ADVIA® 360

Hematology System

ADVIA® 360 Hematology System

Operator’s Guide
Digitally signed by
PHẠM THỊ THU
HÀ
Date: 2022.04.30
10:23:01 +07'00'

11170855 Rev. 03, 2021-05

© 2019–2021 Siemens Healthineers. All rights reserved

No part of this manual or the products it describes may be reproduced by any means or in any
form without prior consent in writing from Siemens Healthineers.

ADVIA is a trademark of Siemens Healthineers.

All other trademarks and brands are the property of their respective owners.

The information in this manual was correct at the time of issue. Access the Document Library for
current information. Siemens Healthineers continues to improve products and reserves the right
to change specifications, equipment, and maintenance procedures at any time without notice.

If the ADVIA 360 Hematology System is used in a manner differently than specified by
Siemens Healthineers, the protection provided by the equipment may be impaired. Observe all
warning and hazard statements.

THE CUSTOMER DOCUMENTATION INCLUDES INFORMATION ON THE SAFETY HAZARDS

ASSOCIATED WITH USE OF THE SYSTEM AND PRECAUTIONS TO BE TAKEN TO AVOID SUCH
HAZARDS. FAILURE TO OBSERVE WARNINGS OR USE OF THE SYSTEM IN A MANNER DIFFERENT
FROM THAT SPECIFIED BY SIEMENS HEALTHINEERS MAY RESULT IN INJURY TO THE OPERATOR OR
OTHER PERSONS. SEE WARNING AND HAZARD STATEMENTS.

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 1 System Overview
Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9
Who Should Use This Manual . . . . . . . . . . . . . . . . . . . . . . . . .9
Conventions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9
Product Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10
ADVIA 360 Hematology System Information . . . . . . . . . . . .11
Hardware Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12
Front Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Back Panel Connectors. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Reagent Connectors. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Left Side . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Built-in Printer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Principles of Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .17
Measured Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Measurement Methods. . . . . . . . . . . . . . . . . . . . . . . . . . . . . .20
Photometric Light Absorbance Method. . . . . . . . . . . . . . . . . . . . . 20
Volumetric Impedance Method . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
3-Part Differential Analysis Method . . . . . . . . . . . . . . . . . . . . . . . 22
Measurement Sequence . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24

2 System Operation
Powering On the System . . . . . . . . . . . . . . . . . . . . . . . . . . . .25
Powering Off the System . . . . . . . . . . . . . . . . . . . . . . . . . . . .26
User Interface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .27
Using the Touchscreen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
Cleaning the Touchscreen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
Entering Information on the System . . . . . . . . . . . . . . . . . . . . . . . 27
Logging In to the System . . . . . . . . . . . . . . . . . . . . . . . . . . . .28
User Management. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .28
Adding a New User . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
Removing a User . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
Setting Automatic Login . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
Editing a User. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30

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3 Sample Measurement and Interpretation of Results

Sample Tubes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
Supported Sample Tube Types. . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
Sample Adapters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
Sample Collection and Handling . . . . . . . . . . . . . . . . . . . . . 33
Sample Types and Sample Modes . . . . . . . . . . . . . . . . . . . . 33
Sample Identification. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
Preparing to Run Samples . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
Running a Blank Cycle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
Running a Patient Sample . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
Remote Work List (EMR) Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
Interpretation of Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
Measure Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
Flags . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39

4 Quality Control
New QC Material Lot . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
Manually Entering a New Lot of QC Material . . . . . . . . . . . . . . . . 46
Using the Barcode Reader to Enter New Lot of QC Material. . . . . 46
Viewing Control Lot Data Files . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
Printing or Exporting Control Lot Data Files . . . . . . . . . . . . . . . . . 47
QC Measure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
Running a QC Measurement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
Viewing a Levey-Jennings Chart . . . . . . . . . . . . . . . . . . . . . . . . . . 47
Displaying Results for a Specific Measurement Point . . . . . . . . . . 48
Showing the Reference Values for a Lot . . . . . . . . . . . . . . . . . . . . 48
Database View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
Displaying the QC Measurement Results in
Database (Table) View. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48

5 Maintenance
Maintenance Schedule . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
Before Daily Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
After Daily Operation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
Weekly Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
Preventative Maintenance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
Cleaning the System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54

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Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
Viewing or Modifying Calibration Factors. . . . . . . . . . . . . . . . . . . 55
Preparing to Run a Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
Running a Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56
Viewing Calibration Events History . . . . . . . . . . . . . . . . . . . . . . . . 57
Viewing the Calibration Database . . . . . . . . . . . . . . . . . . . . . . . . 57
Diagnostics. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .58
Reagent Status. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .59
Replacing Reagents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60
Liquid Sensors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62
Viewing or Saving the Reagent Log History . . . . . . . . . . . . . . . . . 63

6 Troubleshooting
Error Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .65
Mechanical Problems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .65
Sample Rotor Issues. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66
Dilutor Errors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69
Priming Issues – Reagent Warnings . . . . . . . . . . . . . . . . . . . . . . . 70
Touchscreen does not Work. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71
System Does Not Power On . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71
Problems Related to Measurement Results . . . . . . . . . . . . .72
Fluctuating PLT Background . . . . . . . . . . . . . . . . . . . . . . . . . . . . 72

7 Data Management
Database Operations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .73
Database Navigation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73
Viewing Records in the Database . . . . . . . . . . . . . . . . . . . . . . . . . 73
Calculating Statistics for Selected Records . . . . . . . . . . . . . . . . . . 75
Viewing Database Records Details . . . . . . . . . . . . . . . . . . . . . . . . 75
Managing Selected Records in the Database . . . . . . . . . . . . . . . . 76

8 System Configuration Settings

General Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .79
Communication Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . .80
Setting Up Networking . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 80
Setting Up Peer Communication . . . . . . . . . . . . . . . . . . . . . . . . . . 80
Measurement Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .82
Printer Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .83
Date and Time Settings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . .84

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Appendix A: Safety Information

General Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 85
Serious Incident Reporting . . . . . . . . . . . . . . . . . . . . . . . . . . 86
Electrical Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87
Emergency Situations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 88
Moving and Storing the System . . . . . . . . . . . . . . . . . . . . . . 88
Reagent Warnings and Precautions . . . . . . . . . . . . . . . . . . . 89
Safety References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 90
Biohazard Safety Resources. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 90
Barcode Scanner Safety Resources . . . . . . . . . . . . . . . . . . . . . . . . 90

Appendix B: Warranty and Support Information

Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91
About Limited System Warranty and Service Delivery Policy . . . . 91
About the Warranty Period . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91
Support Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 92

Appendix C: Orderable Supplies

Reagents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 93
Approved Controls and Calibrator . . . . . . . . . . . . . . . . . . . . 95

Appendix D: Specifications
System Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 97
Reagent Consumption . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 99
Environmental Requirements . . . . . . . . . . . . . . . . . . . . . . . 100
Electrical Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . 100
Waste Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 101
Known Limitations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 101
Performance Characteristics . . . . . . . . . . . . . . . . . . . . . . . . 101
Accuracy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 102
Precision . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 102
Linearity. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 103
Carryover . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 103

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Sample Stability . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 103

Reference Ranges . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 104
Interfering Substances . . . . . . . . . . . . . . . . . . . . . . . . . . . . 105

Appendix E: Symbols

Appendix F: Barcode Reader

Calibrating the Barcode Reader. . . . . . . . . . . . . . . . . . . . . 111

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8 11170855 Rev. 03
1 System Overview

Intended Use
The ADVIA® 360 Hematology System is a quantitative, fully-automated,
multi-parameter, bench-top hematology analyzer designed for in vitro
diagnostic use in clinical laboratories. The ADVIA 360 Hematology System
is for professional use only.

Who Should Use This Manual

This user manual is intended for clinical laboratory professionals using the
ADVIA 360 Hematology System. The manual includes information about
the operation and use of the ADVIA 360 Hematology System.

Conventions
The operator’s guide uses the following symbol and text conventions.

Convention Description
BIOHAZARD
Biohazard statements alert the operator to potentially
biohazardous conditions.
WARNING
Warning statements alert the operator to conditions
that may cause severe personal injury or loss of life if
operating procedures and practices are not strictly
observed.
CAUTION
Caution statements alert the operator to conditions
that may cause minor or moderate injury to the
operator or patient, the possibility of damage to the
system, or loss of data, if operating procedures and
practices are not strictly observed.
NOTE Note statements alert the operator to important
information that requires attention.

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System Overview ADVIA 360 Hematology System

Convention Description
BOLD Bold type indicates commands on the user interface,
keys, or the exact text that an operator needs to tap,
select, or type.
Italic Italic type refers to the title of a document or a section
title in the operator’s guide.

Product Information
The Document Library includes all customer-facing product information
related to assays, consumables, reagents, calibrators, symbols, security
whitepapers, and the system.
1. From a browser, such as Internet Explorer, on a standalone computer
or tablet, enter https://doclib.siemens-healthineers.com/home.
2. In the top-right corner, select Login/Register > Login.
• Register if this is the first time entering site.
• Login, if already registered.
3. To filter documents by language, ensure a Country/Language
preference is selected.
4. In the search bar, enter 1 or more words and select Enter.
NOTE: Suggested keywords include product name, operator, release
notes, or a specific assay name.
5. View the document by selecting the checkbox by the document.
6. Select Download to view, print, or save the document.

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ADVIA 360 Hematology System Information

The ADVIA 360 Hematology System provides the following hematology
parameters:

GRA# MCH PCT* RBC

GRA% MCHC PDW–CV* RDW-CV
HCT MCV PDW–SD* RDW-SD*
HGB MID# P–LCC* WBC
LYM# MID% P–LCR*
LYM% MPV PLT

* non-USA parameters
See Measured Parameters for full names and description of the
hematology parameters.
The system processes 100 µL of K2 or K3–EDTA anti-coagulated whole
blood from an open or closed sample tube.
The ADVIA 360 Hematology System supports external printers with USB
connectors.
The internal database stores up to 10,000 patient results, separate Quality
Control (QC) and calibration result records including flags and graphical
histograms.
The system features advanced Ethernet LIS connectivity using the HL7
protocol in addition to a standard serial interface.
NOTE: If the system operation is different from the manufacturer’s
specifications, the protection provided by the equipment can be
diminished. Accuracy and precision can also be impaired. Similarly, misuse
of the equipment or use other than that for which the equipment is
designed, invalidates the warranty.

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System Overview ADVIA 360 Hematology System

Hardware Overview
Front Panel
Figure 1: Front Panel

1 Touch-screen
2 Built-in Printer (optional)
3 Side Door Lock
4 Sample Rotor Station

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Back Panel Connectors

Figure 2: Back Panel Connectors

1 Reagent and Waste Connectors

2 Grounding Screw
3 Reagent Key
4 Power Switch (toggle)
5 Power Connector
6 USB (A) Port 1
7 USB (A) Port 2
8 LAN / Ethernet Port
9 USB-B Port

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Reagent Connectors
Figure 3: Reagent Connectors on the Back Panel

1 Reagent Connector Diluent (ADVIA 360/560 Dil 20L)

2 Reagent Connector Lyse (ADVIA 360 Lyse 3P Diff 1L)
3 Reagent Connector Cleaner (ADVIA 360 Cleaner 1L)
4 Waste Outlet Connector 1
5 Waste Outlet Connector 2

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Left Side
Figure 4: 2 USB Ports

Built-in Printer
The optional built-in thermal printer prints on 58-mm wide thermal paper.
The printer has an LED status indicator:
• If LED is lit solid, the printer is ready to use.
• If LED is blinking, the printer requires paper.

Loading Paper into the Built-in Printer

1. Open the paper lid by pulling the lid upwards by the handle.
2. Remove the plastic roller of the old paper roll.
3. Unwind a new paper roll, with the leading edge of the paper facing you
from the bottom of the roll.
4. Gently drop the new roll into the holder of the printer.
5. Hold the leading edge of the paper and ensure that the paper advances
from the front of the printer.

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Figure 5: Loading a New Paper Roll

6. Close the lid, ensuring that the paper is captured between the lid and
the printer mechanics, and that the lid is securely closed.
NOTE: Press the button on the front-right of the printer to advance the
paper.

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Principles of Operation
The system uses a combination of methods to determine measurement
results:
• Impedance measurement technology is used to measure leukocyte
(WBC), erythrocyte (RBC), and platelet (PLT) concentrations.
• A differential lyse reagent is used in measuring the 3-part WBC
differential (LYM, MID, GRA).
• Photometric technology is used to measure the hemoglobin (HGB)
concentration of red blood cells.

Measured Parameters
The ADVIA 360 Hematology System measures the hematology parameters
(including the 3-part WBC differential) shown in Table 1.
The system samples 100 µL of whole blood from a closed or open sample
tube placed in the sample rotor. Measurement cycle time is 60 seconds.

Table 1: Parameters Measured

Parameter Description Unit Calculation Method

9/L
WBC White Blood Cell x10 Number of leukocytes
count or
WBC = WBC cal x counted WBC
x103/μL
RBC Red Blood Cell x1012/L Number of erythrocytes
count or
RBC = RBC cal x counted RBC
106/μL
HGB Hemoglobin g/dL, g/L, Measured photometrically at 540 nm;
concentration mmol/L in each cycle blank measurement is
performed on diluent.

HGB = HGB cal x (HGB measured – HGB

blank)
MCV Mean fL Average volume of individual
Corpuscular erythrocytes derived from the RBC
Volume histogram.

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Parameter Description Unit Calculation Method

HCT Hematocrit percentage, Calculated from the RBC and MCV
absolute values.

HCT percentage = RBC x MCV / 10

HCT absolute = HCT percentage / 100

MCH Mean pg, fmol Average hemoglobin concentration of
Corpuscular depends on erythrocytes, calculated from RBC and
Hemoglobin HGB unit HGB values.
selected
MCH = HGB / RBC
MCHC Mean g/dL, g/L, Calculated from the HGB and HCT
Corpuscular mmol/L values.
Hemoglobin equal to
Concentration HGB unit MCHC = HGB / HCT absolute
selected
RDW–SD* Red Cell fL Distribution width of the erythrocyte or
Distribution platelet population derived from the
Width–SD histogram at 20% of peak

PDW–SD* xDW–SD = RDW cal x (P2 - P1) (fL)

Platelet
fL
Distribution
Width–SD
RDW–CV
Red Cell xDW–CV = RDW cal x 0.56 x (P2 - P1) /
Distribution % (P2 + P1) by the factor of 0.56 CV is
PDW–CV* Width–CV corrected to the 60% cut

Platelet
Distribution %
Width–CV
PLT Platelet count x109/L Number of thrombocytes (platelets)
or
PLT = PLT cal x counted PLT
x103/μL
PCT* Thrombocrit percentage, Calculated from the PLT and MPV
absolute values

PCT percentage = PLT x MPV /10.000

PCT absolute = PLT percentage /100

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Parameter Description Unit Calculation Method

MPV Mean Platelet fL Mean volume of platelets derived from
Volume PLT histogram.

MPV has its own calibration factor.

P–LCC* Large PLT Count x109/L Number of platelets larger than 12 fL
or
x103/μL
P–LCR* Large PLT % Percentage of platelets larger than
percentage 12 fL

P–LCR = P–LCC/PLT
White blood cell Absolute values counted in the
3-part channels determined by the 3 WBC
differential: discriminators:
LYM# Count and % of x109/L
LYM% lymphocyte
or
cells
x103/μL
MID# MID% Count and % of
medium size
cells

Percentages calculated from the

absolute WBC value.

LYM# = LYM% x WBC

MID# = MID% x WBC

GRA# = GRA% x WBC

GRA# Count and % of
GRA% granulocyte
cells

* non-USA parameters

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Measurement Methods
The ADVIA 360 Hematology System uses the following 3 methods to
determine measurement results:

Method Description
Photometric Light Measures the WBC dilution to determine
Absorbance Method the hemoglobin (HGB) concentration of
erythrocytes (RBC).
Volumetric Impedance Measures the cellular concentrations and
Method volume distributions of erythrocytes (RBC),
and platelets (PLT) from RBC dilution.
The volumetric impedance method is also
used with a lytic reagent to determine the
distribution of leukocytes (WBC), and their
3 sub-populations (LYM, MID, GRA).
3-Part Differential Analysis Counts and simultaneously size-
Method differentiates the white blood cells by using
a WBC lytic process.

Photometric Light Absorbance Method

The lyse reagent causes the red blood cells to release cellular hemoglobin.
The hemoglobin concentration is measured by taking a photometric
reading across the ADVIA 360 Hematology System WBC chamber.
The HGB result is calculated as the difference between a blank and a
sample measurement with and without illumination to reduce the effect of
liquid refraction and incident light.

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ADVIA 360 Hematology System System Overview

Volumetric Impedance Method

The volumetric impedance method determines cellular concentrations and
volume distributions of cells. The ADVIA 360 Hematology System detects
and measures changes in electrical impedance when particles that are
suspended in a conductive liquid pass through a small aperture.
A constant direct current flows between the electrodes on both sides of the
aperture. Each cell passing through the aperture causes a change in the
electrical impedance of the conductive blood cell suspension (diluted
blood). This impedance change is detected by the system electronics and
the change is converted to an electrical voltage pulse. The number of
pulses is proportional to the number of particles in the diluted sample.

Figure 6: Volumetric Impedance Method

1 Current generator 7 Electrodes

2 Voltage meter 8 Aperture
3 Voltage 9 Measuring chamber
4 Voltage pulse 10 Diluted blood
5 Time (µ sec) 11 Electrodes
6 Cell passing the aperture

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System Overview ADVIA 360 Hematology System

Intensity (amplitude) of each voltage pulse is proportional to the volume

of the particle. The volume distribution diagrams of the particles are
displayed as the WBC, RBC, and PLT histograms measured in
femtoliter (fL, µm3) units.
Electronic discrimination by size allows separation of platelets (PLT) and
erythrocytes (RBC), and leucocytes (WBC). Discriminators are indicated by
dotted vertical lines on the histograms.

RBC histogram WBC histogram

3-Part Differential Analysis Method

The ADVIA 360 Hematology System is a 3-part WBC differential
hematology analyzer. The ADVIA 360 Hematology System uses
electronic sizing and a lytic process to determine 3 distinct white cell
subpopulations.
Cells correlating to lymphocytes are included in the small cell
subpopulation.
Cells correlating to granulocytes are included in the large cell
population.
The remaining cells correlating to monocytes, basophils, eosinophils,
blasts, and other precursor white cells are included in the mid-size cell
population.

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ADVIA 360 Hematology System System Overview

Three elements determine where the different cell types fall in the WBC
histogram:

Element Description
Chemical formulation and The lytic reagent controls how different
concentration of the lytic WBC types are differentially lysed.
reagent Concentration of the lytic reagent controls
the rate of the lysing (shrinking) process
during the incubation time.
Type and maturation of the Different WBC types and grades of
cells present for analysis. maturation have different sensitivities to
3-part WBC differential the lytic reagent.
analysis: LYM, MID, GRA Different WBC types lyse at different rates:
• Lymphocytes are the most
sensitive type.
• Band neutrophils and segmented
neutrophils are the least
sensitive types.
Eosinophils, basophils, monocytes,
immature granulocytes and blasts are
classified as mid-size cells based on their
cell membrane sensitivity to the lytic
process.
Time window in the lytic This is the time frame for counting and
process sizing cells.
As the lytic process is a dynamic reaction,
the count and sizing-time window used
during the lytic process has been optimized
for performance.

Particle data presents a size-distribution histogram of the WBC populations.

Since size distribution is the only data available for the WBC histogram, the
resolution is not high enough to accurately differentiate more than 3
distinct WBC populations. Consequently, all possible normal and abnormal
WBC cell types fall into one of the 3 histogram populations. Therefore,
when abnormal WBC populations are present in the sample, resolution is
not high enough to accurately generate specific morphological flags. This
is a well-recognized limitation of all 3-part differential WBC cell counter
systems in the market today.

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System Overview ADVIA 360 Hematology System

Measurement Sequence
The ADVIA 360 Hematology System performs sample preparation in
several stages. Table 2 is an example of a sample preparation.

Table 2: Sample Preparation Process

Stage Description
1 The sampling needle moves into the sample tube, and aspirates
100 µL of EDTA anti-coagulated venous whole blood sample.
The 25 µL of this sample is separated in the sampler head. The
remaining blood is disposed of through the sampling needle
into a dedicated washing chamber.
2 The 25 µL of whole blood sample is transported to the mixing
chamber through the sampling needle with an addition of 4 mL
diluent, to form a 1:160 primary dilution.
25 µL of this diluted sample is aspirated into the sampler head,
and then mixed with another 4 mL of diluent dispensed into the
RBC chamber. This forms a 1:25,600 overall RBC dilution.
3 The remaining mix dilution moves into the WBC chamber where
0.9 mL of lysing reagent is added.
The ADVIA 360 Hematology System uses bubbles for mixing
lyse with the mix dilution.
This lytic dilution of the 1:196 is suitable for photometric
measurement and WBC counting.
4 The WBC cell counting is performed for 2–6 seconds.

HGB is measured for 2 seconds at the end of the WBC counting

process.
5 The RBC and PLT counting is performed for 5 seconds.
6 The system drains and cleans measuring chambers and related
tubing, and prepares for the next blood sample.

Apertures are cleaned with high-voltage burning pulses.

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2 System Operation

Powering On the System

1. Power on all external and peripheral devices, such as printer and host
computer.
2. Power on the ADVIA 360 Hematology System by pressing the main
power toggle switch on the back of the system.
An I indicates the power-on position. See Figure 2 in Chapter 1,
Hardware Overview.
3. After powering on the system, wait 5 minutes before initiating any
measuring process to allow the system to reach optimal working
temperature.
During start up, the ADVIA 360 Hematology System screen appears for a
few seconds, then the Home screen displays.

Figure 7: Home screen

1 Measure 4 Exit
2 Database 5 Settings
3 Maintenance 6 Quality Control

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System Operation ADVIA 360 Hematology System

If the fluidic system requires additional liquid and the fluid sensors are on,
the ADVIA 360 Hematology System automatically runs a priming cycle.
Run a priming cycle in the following circumstances:
• After installation
• After an extended unused period
• After the replacement of any component related to the fluidic system
• After the replacement of any reagents

Powering Off the System

WARNING
Do not shut down the system by pressing the power switch on the rear
panel without initiating Shutdown from the Home Screen. Powering off
using only the rear panel power switch can result in erroneous operation,
loss of data, or a prolonged start-up cycle during subsequent use of the
system.

CAUTION
If the shut-down procedures are not followed, a blood sample could
remain inside the system and increase the risk of contamination causing
carryover. A dried blood sample in the system can permanently block the
sample path.

Powering off the system must be initiated from the Home screen because
the software shutdown performs a crucial shutdown sequence:
• Saves data, settings, closes the databases. (If the power is turned off
before all data items are securely saved, data might be lost.)
• Cleans and flushes debris from the system to prevent clogs and
contamination.
• The system moves mechanical parts (sample needle, syringe
pumps, valves) into safe, home positions.
1. On the Home screen, tap Exit.
2. On the Exit screen, tap Shutdown.
You can safely power-off the system when a warning message displays
and the system emits a sustained tone.
3. Power off the system using the power switch on the rear panel.
The Off position is marked by the O symbol.

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ADVIA 360 Hematology System System Operation

User Interface
Interact with the system by using the touchscreen and the virtual on-
screen keypad, or by using an external keyboard and a mouse.

Using the Touchscreen

• Operate the touchscreen with a finger or a conductive stylus designed
for touchscreens. The screen is not pressure-sensitive.
• The touchscreen supports simple operations, but does not support
multi-touch gestures and multiple tapping.
• If the touchscreen is dirty, the system may not recognize your
selections. Clean the screen.

Cleaning the Touchscreen

Ensure that the system is off before cleaning the screen. Use a mild soap
and water solution with a microfiber cloth recommended for cleaning
electronics. Mild soaps include the following ingredients:
• U.S. Pharmacopeia (USP) green soap
• Sodium hypochlorite solution (1:10 dilution of household chlorine
bleach in water).
NOTE: Using this solution can lighten color over time.
• Phenolic germicidal detergent (1% aqueous solution)
• Cidex 2.4% Activated Glutaraldehyde Solution
• 50% isopropyl alcohol mixed in 50% water solution
• Steriplex
• Novus 1

Entering Information on the System

The ADVIA 360 Hematology System often requires the operator to enter
information such as sample ID or patient data. Enter information into a
data field by tapping the data entry field. An enabled data entry field is
white.
When tapping an enabled field, the border changes color indicating that
the field is active and data can be entered.
If a data entry field is disabled or unavailable, the field appears darker or
shaded.

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System Operation ADVIA 360 Hematology System

Enter information using the on-screen keyboard or keypad or with an

external keyboard and mouse.
Data is not saved until you select Enter, Save, or Accept, depending on the
particular screen. Select Cancel to discard changes and return to previous
screen.

Logging In to the System

An operator must enter a login ID and password to use the system.
1. On the Home screen, select Exit.
2. Tap Log in.
3. Tap the Login name field and select a user.
4. Type the password and tap Enter on the on-screen virtual keypad.

About Administrator Accounts

Only Administrator (Admin) accounts can add or change new users.
When logged in as Admin, the User management screens are available.
NOTE: Siemens Healthineers strongly recommends changing the default
Admin password, so that the user privileges cannot be changed without
authorization. The default Admin password is 0.

User Management
Administrators use the User Management screen to add users, delete
(remove) users, and modify permissions.

Task Action
To set up a new user account. Tap Add new user
To delete an existing user account. Tap Remove user
To set up automatic login. Tap Automatic login set
To modify an existing user account. Tap Edit user

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ADVIA 360 Hematology System System Operation

The system administrator controls access to the ADVIA 360 Hematology

System to ensure that only authorized users operate the system, by setting
a User Type for each operator. There are 3 user types:

User Type Description

Admin Administrator users have access to all system functions
and can create new Admin users.
Advanced Advanced users can access all functions, except for setting-
up users. For example, Advanced users have the authority
to perform critical system functions, such as maintenance
and calibration.
Basic Basic users can run samples, but cannot perform
calibration or change system settings.

Adding a New User

1. On the Home screen, select Exit > User Management.
2. On the User Management screen, tap Add new user.
3. On the Add new user screen, tap the Login Name field.
4. Enter the login name for the new user.
This is an alphanumeric field.
5. Tap the Password field and enter the new password.
6. Tap the Re-enter password field and reenter the password.
7. Select a User type: Admin, Advanced, or Basic.
Tap the User type field to scroll through the 3 types.
8. Enter the Name, Phone, and Email address.
9. Select Accept to save the new user account.
To exit without saving the new user, tap Cancel.

Removing a User
1. On the Home screen, select Exit > User Management.
2. On the User Management screen, tap Remove User.
3. Tap the Login field to scroll through user names until locating the user
name to remove.
4. Tap Accept.
To exit without removing the user, tap Cancel.

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Setting Automatic Login

To have the system automatically log in a particular user upon system
startup, set the Automatic log-in feature.
1. On the Home screen, select Exit > User Management.
2. On the User management screen, tap Automatic login set.
3. Tap the Login name field and select the user account for automatic
login.
4. Tap Accept.

Changing Automatic Login Set User

If the Automatic Login feature is set for an existing user, the system logs in
as that user.
1. On the Home screen, select Exit > User Management.
2. On the User Management screen, tap Automatic login set.
3. Tap the Login field to scroll through user names until the login name
for the automatic login displays.
4. Tap Accept.

Turning Off Automatic Login

1. On the Home screen, select Exit > User Management.
2. On the User Management screen, tap Automatic login set.
3. Tap the Login name field until Automatic login off displays.
4. Select Accept.

Editing a User
1. On the Home screen, select Exit > User Management.
2. On the User Management screen, tap Edit user.
3. Tap the Login name field to scroll through the user names.
4. Select the user name and tap Accept.
5. In the Edit User screen, tap the fields to update.
6. Tap Accept.

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3 Sample Measurement and Interpretation of
Results

Sample Tubes
Supported Sample Tube Types
The ADVIA 360 Hematology System supports K2- or K3-EDTA, 13 x 75-mm
sample tubes:
• Becton Dickinson (BD) Vacutainer
• Terumo Venosafe
• Sarstedt Monovette in open mode only
Sample tubes supplied by other vendors must meet these conditions:
• The tube is mechanically compatible (13 x 75-mm) with the sample
rotor and adapter.
• The tube cap can be pierced or used in open sample tube mode.
Although these sample tube types are designed for multiple piercing,
Siemens Healthineers recommends removing the cap after 3–4 piercing
cycles. Rubber pieces from the cap can clog or contaminate the sample,
adversely affecting the performance of the system.
NOTE: Do not place multiple labels on the sample tube. Multiple labels can
prevent the sample tube from fitting in the sample adapter.

Sample Adapters
The ADVIA 360 Hematology System can process both open and closed
sample tubes in the sample rotor.
Before placing a sample tube into the sample rotor, place the sample tube
into the standard sample adapter.

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Standard Sample Adapter

The standard adapter is used for piercing vacutainer tubes of 13 x 75-mm,
and control tubes.

Figure 8: Standard Adapter

1 Vacutainer with cap removed

2 Vacutainer with cap
3 5-mL Control tube with screw-cap removed

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ADVIA 360 Hematology System Sample Measurement and Interpretation of Results

Sample Collection and Handling

When processing samples follow these guidelines:
• Blood samples must be analyzed within 7 hours of collection.
• The blood and anticoagulant must be properly mixed by inverting the
tube at least eight times. Do not shake the sample as this could damage
blood cells and cause micro bubbles.
• A minimum of 30 minutes must elapse between taking the blood
sample and running the sample on the ADVIA 360 Hematology System.
This period ensures that the blood and anticoagulant have fully
stabilized.
• Samples must be room temperature when analyzed.

BIOHAZARD
Handle all blood samples as potentially infectious material that represent a
biohazard.
Wear personal protective equipment. Use universal precautions. See the
operator’s guide for your system for recommended safety precautions
when working with biohazardous materials.

Sample Types and Sample Modes

The ADVIA 360 Hematology System processes the following 3 sample
types:
• Whole human venous blood (Male, Female, Profiles 1–7)
• Calibrator
• Quality Control
Select the sample mode before a measurement starts. The
ADVIA 360 Hematology System has the following 3 Sample Modes:

Sample Mode Description

Blank Mode No sample has to be presented to run a blank. Blank
mode checks that the measuring system is operating
correctly.

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Sample Measurement and Interpretation of Results ADVIA 360 Hematology System

Sample Mode Description

Control (QC) The hematological parameters of QC and control
Mode materials are known prior to analysis. Controls are
used to check the long-term stability of the
ADVIA 360 Hematology System.
Human Blood Ten human blood profiles are available: Human, Male,
Mode Female, and Profiles 1–7.
Each mode has a unique set of normal ranges associated
with it. For Profiles 1–7 the name of profile can be
changed and the normal ranges can be redefined by the
operator.

NOTE: Calibration with calibrator material is not one of the

ADVIA 360 Hematology System sample modes. Calibration is a separate
and specific procedure (Home > Maintenance > Calibration).

Sample Identification

CAUTION
Do not enter incorrect sample ID or patient ID information. If samples are
misidentified, patient results will be reported incorrectly.

Sample identifiers are used to distinguish each sample.

Sample Identifiers Description

Sample Mode Blank, Control, Human, Male, Female, and
Profiles 1–7.
Time of measurement Assigned automatically—time-stamped in
60 second increments—by the system software

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ADVIA 360 Hematology System Sample Measurement and Interpretation of Results

Sample Identifiers Description

Sample ID The Sample ID does not apply to Blank mode
runs.
The Sample ID can be submitted by any of these
methods:
• Manual typing
• Manual barcode reader
• Automatically assigned by the
ADVIA 360 Hematology System software
You can run the sample ID through the system
multiple times for repeated measurements.
Patient ID Assigned by the operator using a keyboard.
NOTE: Patient ID is not applicable for Blank or
Control runs.

Preparing to Run Samples

After powering on the ADVIA 360 Hematology System, ensure the system
is ready to process samples:
• All reagents and the waste receptacle are properly connected.
• Blank cycle has been run and accepted (see Running a Blank Cycle).
• Quality Control materials have been tested and produced acceptable
results, so that calibration of the system is valid. (See Chapter 4,
Quality Control for more information.)
• The sample is ready to use, well-mixed, and is within the
recommended time frame for measurement (see Sample Collection
and Handling).

Running a Blank Cycle

A blank cycle is a cycle that is run without a sample to ensure the
cleanliness of the system:
• An acceptable blank cycle must be run before running patient samples,
controls, or calibrators.
• An acceptable blank cycle must be run before sample analysis starts,
and at the beginning of every shift.

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Sample Measurement and Interpretation of Results ADVIA 360 Hematology System

• An acceptable blank cycle must be run if the system has not been used
for more than 3 hours.
• An acceptable blank cycle must be run after any reagent replacement
or maintenance operation.
1. On the Home screen, select Measure > New Sample.
2. Tap Blank.
After 1 minute, the system displays blank values. Acceptable blank
value ranges:

Parameter Acceptable Range

HGB 0–1 g/dL
WBC 0–0.5 x 103 /µL
PLT 0–10 x 103 /µL
RBC 0–0.05 x 106 /µL

3. If the blank values are within acceptable ranges, tap Accept.

If one or more parameters are out of range, run a blank cycle 2 or 3 more
times, by tapping the Re-blank.
If blank values are consistently high for any parameters, run Cleaning or
Hard cleaning. See Chapter 5, Cleaning the System.

Running a Patient Sample

NOTE: An accepted blank cycle must be performed before running
samples. See Running a Blank Cycle.
1. Mix the sample gently but thoroughly by inverting the sample tube
8–11 times.
For more information, see Sample Collection and Handling.
2. On the Home screen, select Measure > New Sample.
3. Insert the appropriate tube adapter into the sample rotor.
4. Open the tube, if necessary.
5. Place the sample tube into the adapter.
6. Select a sample Type (Human, Male, Female, Profile 1-7).
7. Identify the sample (Sample ID) either manually or by scanning the
barcode. See Sample Identification.

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ADVIA 360 Hematology System Sample Measurement and Interpretation of Results

8. Tap Run.
The sample rotor turns in and the needle aspirates 100 µL of sample
from the tube. The sampling needle is then retracted, and the surface is
automatically rinsed with diluent. After a few seconds, the sample
rotor turns out.

WARNING
Do not reach inside the ADVIA 360 Hematology System during piercing.
The needle can puncture skin, resulting in personal injury

9. Remove the sample tube from the adapter.

After 1 minute the system displays the results. See Interpretation of
Results in this chapter for result interpretation.
If a blank cycle was not performed before the sample run, this message
displays:
There is no valid blank measurement. Press OK
to measure a blank first.

Remote Work List (EMR) Mode

If a work list was sent to the ADVIA 360 Hematology System from an LIS
(Laboratory Information System), the list is available in the Measure
screen.
1. On the Home screen, select Measure > New Sample.

2. In the New Sample screen, tap EMR (LIS) to show the list of samples to
be measured.

3. Tap Sample ID to select a sample, or scan the barcode of a sample from

the list to automatically set the Sample ID.

4. Tap Run.

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Interpretation of Results
This section describes results and flags.

Measure Screen
The Results of a sample are displayed in the Measure screen (Home >
Measure) in the following categories:
• Parameters
• Normal Ranges
• Tech Details
The ID header at the top of the screen remains the same for each category
of results and displays information:
• PID – Patient ID, date and time of sample run
• SID – Sample ID and sample Type
• Warning flags when appropriate

Results Screen: Parameters

• Values within the normal range display in white.
• Values outside the normal range display in red, and the system flags
the values:
○ L - if lower than normal range
○ H - if higher than normal range
• Histograms display graphical information about volume distribution of
WBC, RBC, and PLT. Histograms indicate discriminators by vertical lines
that separate different cell populations.

Results Screen: Normal Ranges

• Normal ranges display in a graphical format on the right of the screen.
A downward-pointing white arrowhead indicates each value within the
normal range graphics.
• Low and high limits of the normal range are displayed on either side of
the range line.
If the value is out of normal range, the line is red, otherwise the value is
green.
If a normal range has not been defined for a particular parameter, a normal
range graphics does not display.

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Results Screen: Technical Details

• Probe voltage: Shows electrode voltages for counting WBC and RBC.
The min. and max. values are shown for service purposes only.
• WBC lyse volume: The default value is 0.9 mL.
• Diagnostic flags: Shows evaluations made by the system based on the
results. Diagnostic flags can appear on the Results screen.
• Warning flags display for the measurement.

Flags
This section describes diagnostic and warning flags.

Out-of-Normal-Range Flags
• The first flagging method is an evaluation against the normal ranges.
• Out-of-Range parameters are highlighted in red.
If the parameter is under the normal range, an L flag displays.
If the parameter is over the normal range, an H flag displays.
• The operator can establish normal ranges for each Profile provided by
the software. (See Chapter 8, Setting Normal Ranges for Measured
Parameters.)
NOTE: If a 0 (zero) value is set for a range limit of a parameter, the
parameter cannot be verified, and no normal range graphics generate.

Measurement Condition Flags

If the ADVIA 360 Hematology System cannot interpret measurements
appropriately, condition flags are attached to the result. These flags display
in the header section of the Measure screen (Home > Measure), indicated
by a Warning. These condition flags also appear in the Tech Details screen
(Home > Measure > Tech Details) with a short explanation.

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Flagging on WBC and HGB channels

Uppercase letters — WBC or HGB flags.

Flag Meaning Explanation Recommended Action

E No WBC 3-part Possible lyse Rerun sample, making
differential problem, or sample sure to use sufficient
was inadequate. Can volume.
also occur in
pathological
lymphocytosis.
W 3-part differential Possible lyse Run prime lyse, and
warning problem, or the rerun sample.
sample is more than
7 hours old.
G HGB blank is high, Probably bubbles in Repeat a blank cycle.
or no HGB blank the WBC chamber. Run prime lyse, run
cleaning, and run blank
again. Close the side
door if open during
measurement.
B WBC blank is high, Possible lyse Repeat blank cycle, or
or no WBC blank contamination or run prime lyse and try
noise problem. blank cycle again.
C WBC clogging Aperture clogged or Perform cleaning of
low temperature aperture or hard
reagent can also cleaning and rerun
cause this flag sample. If this flag
(mainly diluent). persists, contact your
technical support
provider or distributor.
In the case of low
temperature reagent,
wait until the reagent
warms to room
temperature.
M WBC coincidence N/A Rerun sample after
is too high. manual pre-dilution
Linearity error. and correct the
proportional results
D WBC/RBC The RBC–WBC Rerun or use alternate
threshold discriminator is over method.
Interference 45 fL on the
histogram.

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ADVIA 360 Hematology System Sample Measurement and Interpretation of Results

Flagging on RBC/PLT channel

Lowercase letters — RBC/PLT flags.

Flag Meaning Explanation Recommended

Action
p PLT blank is high, Diluent or system Run cleaning or Hard
or no PLT blank cleanliness problem cleaning and repeat a
blank cycle.
Check for bubbles at
reagent inlets, and
prime diluent. If the
diluent is stable high,
replace the diluent.
b RBC blank is high, N/A Run cleaning or Hard
or no RBC blank cleaning and repeat a
blank cycle.
Check for bubbles at
reagent inlets, and
prime diluent. If diluent
is stable high, replace
the diluent.
c RBC/PLT clogging N/A Perform a cleaning of
the aperture or Hard
Cleaning and rerun the
sample. If this flag
persists, contact your
technical support
provider or distributor.
In the case of low
temperature reagent,
wait until the reagent
warms to room
temperature.
m RBC/PLT N/A Rerun sample after
coincidence is too manual pre-dilution
high. Linearity and correct the
error. proportional results.
d RBC/PLT threshold The analytical Rerun or use an
interference software could not alternate method.
separate RBCs from
PLTs because of a
population overlap.
Possibly clumped
PLTs.

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Warning Flags of Differential Parameters

Flag Parameter Flag Type Flag Description Possible Indication

H LYM cell The following sample-related
LYM% Distributional population > 46% causes do not contain all
L LYM cell conditions that could cause
population < 11% these flags.
H GRA cell • Hemolysis
GRA% Distributional population > 81% • Cryoglobulins
L GRA cell • Chylomicrons
population < 44% • Pyropoikilocytosis
• Lipemia
Multiple occurrences of these
flags, especially for
consecutive samples, can
indicate a system problem.
However, isolated instances
of this flag are usually sample
related.
H MID% Distributional MID cell Abnormal WBC cell types;
population > 17% immature granulocytes;
blasts; basophilia,
monocytosis, esosinophilia;
Chronic inflammation;
Leukoerythroblastic pattern if
combined with a d or D
region interference flag.
D N/A Region Interference WBC fragments, RBC
Interference between PLT and agglutination
WBC population
d N/A Region Interference Nucleated RBCs, Giant
Interference between PLT and platelets, Platelet clumps
RBC population

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ADVIA 360 Hematology System Sample Measurement and Interpretation of Results

Blank Cycle Flagging

Parameters are flagged if the operator has accepted a high blank value. In
some cases the associated parameter is flagged, but in other cases the
parameter is dashed out.

Parameter Value is displayed but Value is dashed-out (---)

flagged by an * (!) and flagged by an E (error)
(asterisk and flag
exclamation)
WBC 0.50–85x 103 /µL > 85 x 103 /µL
HGB 1–25 g/dL > 25 g/dL
RBC 0.05–8 x 106 /µL > 8 x 106 /µL
PLT 10–1000 x 103 /µL > 1000 x 103 /µL

NOTE: Perform a cleaning cycle then run a blank cycle to correct blank
cycle measurement flags.

Known Limitations in WBC Differentials

• Each laboratory is responsible for establishing their own protocols for
addressing flags. The ADVIA 360 Hematology System classifies cells
based only on size differentiation. The system cannot flag specimens
with morphologic abnormalities of any particular cell type.
• Due to the limited performance characteristics of the system, some
abnormal cell types that are present at low frequencies may not be
identified.
• The ADVIA 360 Hematology System does not have the resolution to
differentiate atypical or abnormal lymphocytes from normal
lymphocytes based strictly on size alone.
• The ADVIA 360 Hematology System does not classify or flag nucleated
red blood cells.

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44 11170855 Rev. 03
4 Quality Control

This chapter specifies recommended quality control material and quality

control frequency for the individual method.
Siemens Healthineers recommends monitoring the
ADVIA 360 Hematology System using the ADVIA 360 Control Set (Low,
Normal, and High).
Assay the control materials when any of the following situations occur:
• At the beginning of each shift, or an interval chosen by the laboratory.
• After a reagent log number change.
• After replacement of any part or component of the analytical module
that can affect analytical performance.
The laboratory must evaluate all control results before reporting patient
results. If control results fail to meet the laboratory's established criteria for
acceptability, all patient test results obtained in the unacceptable test run
must be evaluated to determine if patient test results were adversely
affected. The laboratory should perform and document appropriate
corrective actions, which can include recalibration and reassaying of
patient samples, before reporting patient results.
By analyzing control materials on a regular basis, day-to-day reproducibility
and general condition of the analyzer can be monitored. Target values and
acceptable (tolerance) ranges for each parameter can be specified for an
unlimited number of QC materials.

New QC Material Lot

Before performing any QC measurements, you must enter target values
and tolerance ranges for each parameter of the QC material being used.
Enter the information for a new lot of QC materials by scanning the
barcode or manually entering the data.
The assay sheet that comes with the QC material contains the target values
and tolerance ranges for that particular lot.
NOTE: Target values and tolerance ranges of the QC material are set once
for each lot. When target values and tolerance ranges are reset, the
previous QC results are deleted. Similarly, any change made to the QC
control setting also deletes the previous QC results. Siemens Healthineers
recommends printing QC results before entering new values.
Use control materials before their expiration date. Always observe the
control manufacturer’s instructions for storage and use. Control materials
must be well mixed before use.

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Manually Entering a New Lot of QC Material

1. On the Home screen, select Quality Control > Set QC reference.

2. In the QC Reference screen, enter the QC identifying information,

target values and tolerance ranges for any parameters that are to be
controlled with the ADVIA 360 Hematology System QC system.
NOTE: Exclude a parameter from the QC procedure by leaving the
target fields and tolerance range fields empty.

3. Tap Save reference.

Using the Barcode Reader to Enter New Lot of QC

Material
1. On the Home screen, select Quality Control > New Lot.
2. Use the barcode reader to scan target and range values from the
ADVIA 360 Hematology System assay sheet.
You can enter the data manually by tapping the LOT field, typing the
lot number of the control material, then tapping Enter.
3. Tap the Level field and select Normal, Low, or High.
4. Type in the correct expiration date.
Use the appropriate date format for your system.
5. Tap Enter.
6. Enter the Target values and Tolerance ranges manually.
7. Tap Accept.

Viewing Control Lot Data Files

1. On the Home screen, select Quality Control.
2. Tap the radio button to the left of the Lot name to view the lot.
3. Tap Monthly view.
4. On the QC Monthly View window, use the arrows on the QC lot that
were measured in mm/yyyy field to scroll through the QC lots.

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Printing or Exporting Control Lot Data Files

1. On the Home screen, select Quality Control.
2. Tap the radio button to the left of the Lot name.
• Tap Print.
• Tap Export to write the selected records as an ASCII file (.txt) to a
USB storage device.
If a USB storage device is not detected, the system prompts you to
insert a USB storage device.

QC Measure

Running a QC Measurement
1. Ensure that a valid blank measurement has been run and accepted.
2. On the Home screen, select Quality Control > QC measure.
3. On the QC measure screen, select the matching QC name in the
selector field below QC measure (marked by the left and right arrow),
4. Select Measure.
5. Place the control material sample tube in the sample rotor, and
tap Run.
QC measurement results are saved to the QC database and associated with
matching QC material lot.

Viewing a Levey-Jennings Chart

The QC database contains the results of QC measurements in Levey-
Jennings format and in a database table format.
1. On the Home screen, select Quality Control.
2. Select a Control Lot by tapping the radio button to the left of the Lot
name.
3. Tap the greater-than control (>) to the right of the expiration date.
The Levey-Jennings chart displays:
• The mean and the specified range display on the right of each
parameter.
• Measurement points are indicated by a white o.
• Out-of-range points are indicated by a red x.

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Navigating Through a Levey-Jennings Chart

Navigate through the Levey-Jennings chart to view the different
parameters of the results by tapping the up or down arrows near the
bottom of the screen.

Displaying Results for a Specific Measurement Point

1. Tap the left or right arrows on either side of View to scroll to a specific
measurement.
2. Tap View.
The record details screen that is displayed shows the parameter
measurements.
3. Tap Normal ranges and Tech Details to view those results for that
particular measurement.

Showing the Reference Values for a Lot

1. On the Home screen, select Quality Control.
2. Tap > (greater-than) to the right of the expiration date.
3. Tap References.
NOTE: The fields are not writable and cannot be changed.

Database View

Displaying the QC Measurement Results in Database

(Table) View
1. On the Home screen, select Quality Control.
2. Tap the radio button in front of the Lot name.
3. Tap > (greater-than) to the right of the selected lot information.
4. Tap Database.
In the Database table, navigate through all parameters by tapping the
left or right arrows at the bottom of the screen.
View subsequent and previous samples in the database by tapping the
up or down arrows. See Chapter 7, Data Management, for information
on database options.

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Operators can access, maintain, and check the fluidic system and
mechanical parts that are located behind the right-side door of the
ADVIA 360 Hematology System:
• Tubing and chambers
• Wash head on the X-Y needle mechanics

WARNING
Do not open or service the following parts:
• Power supply
• Instrument housing and electronic boards
Accessing these parts can cause damage to the system.

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Figure 9: Operator accessible area (Located inside the right-side door)

1 Needle Chamber / 8 Sample micro-dilutor

Drain Chamber
2 Mixing Chamber 9 Lyse Dilutor
3 RBC Chamber 10 Dilutors
4 X-Y Sampling Unit with 11 Valves
Piercing Needle
5 Sampler Head 12 HGB Head
6 Reagent Sensors 13 WBC Aperture Assembly
Chamber
7 Vacuum Receiver Chamber

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Maintenance Schedule
Before Daily Operation

CAUTION
Do not lift the waste tank when the waste tank reaches 80% or more
capacity. A waste tank that is 80% full can be heavy to lift. If lifting this
weight is a concern, empty the waste tank before the waste tank
becomes 80% full.

Task Instruction
1. Check reagent condition On the Home screen, select
Maintenance > Reagent status.
Check the reagent container to ensure
there is enough liquid for the expected
number of daily measurements.
2. Check the contents of the If the level is above 80% full, empty the
waste tank tank.
3. Check for air bubbles Inspect the rear reagent liquid
connectors and syringes (except waste
line).
If there are bubbles, prime the reagent
and perform a blank run.
4. Run blank measurement If the results of the blank run are within
range, tap Accept and proceed with the
routine.
5. Run QC samples Run QC samples according to
established laboratory protocols before
patient samples.

After Daily Operation

At the end of the work day perform the daily cleaning.
1. On the Home screen, select Maintenance.
2. Tap Cleaning.

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Weekly Maintenance

BIOHAZARD
All products or objects that come in contact with human blood, even after
cleaning, should be handled as if capable of transmitting infectious
diseases. Wear facial protection, gloves, and protective clothing. Refer to
Protection of Laboratory Workers from Occupationally Acquired Infections;
Approved Guideline–Third edition, (2005), Document M29-A3,
promulgated by the Clinical and Laboratory Standards Institute (CLSI), for
information about user protections when working with biohazardous
material.

WARNING
Do not touch the piercing needle without wearing rubber gloves. The
sharp tip of the piercing needle can puncture skin, resulting in personal
injury. Always use rubber gloves and a cotton swab to clean the wash
head to avoid injury to fingers.

Maintenance Task Instruction

Performing Hard Add 1 mL of ADVIA Hypoclean CC reagent into a
Cleaning sample tube and run the Hard Cleaning
function: Home > Maintenance > Cleaning >
Hard Cleaning.
Checking Tubing Open the side door and look for any liquid
System leakage. Contact an authorized technician if
there is leakage.
Cleaning the Needle 1. Perform the shut-down procedure: Home >
Wash Head Exit > Shutdown.
2. Power off the system.
3. Open the side door.
4. Use a moistened cotton swab to remove
salt and blood residuals from the bottom of
the needle wash head (Figure 10 ).

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Figure 10: The Needle Wash Head

Preventative Maintenance
Certified service personnel should perform service maintenance on the
ADVIA 360 Hematology System every 10,000 measurements or annually.

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Cleaning the System

WARNING
Disconnect the ADVIA 360 Hematology System from the power supply
before cleaning the chassis of the analyzer and front cover. If the power
is not disconnected, damage can occur to the system or mechanical parts
can move and cause personal injury.

• Clean the system on the outside only, using a lint-free tissue damp with
a 5% sodium hypochlorite solution.
• Do not allow liquids inside the unit or near the electrical connectors.
On the Home screen, select Maintenance > Cleaning.

Tasks Description
Cleaning Home > Maintenance > Cleaning > Cleaning
Starts a wash cycle using the cleaning reagent
connected to cleaner input.
A cleaning cycle is automatically performed during a
start up and a shutdown procedure.
Hard cleaning Home > Maintenance > Cleaning > Hard Cleaning
Perform a hard cleaning as part of the weekly routine
maintenance.
The software prompts for insertion of the cleaning
solution into the sample rotor using a sample tube.
NOTE: Clogging errors or high PLT blank values
indicate the need for additional hard cleaning.
Drain Chamber Home > Maintenance > Cleaning > Drain Chamber
Drain Chamber is only used during troubleshooting
or component replacement.
Run the Drain Chamber task before removal or
replacement of parts related to the measuring
chambers or apertures. This is a service personnel
task.

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Calibration
The ADVIA 360 Hematology System must be calibrated for all parameters.
Siemens Healthineers recommends using the ADVIA 360/560 Calibrator.
Perform the Calibration procedure:
• Upon installation of the system.
• If there is a significant shift in control values after the replacement of a
critical hardware component or reagent lot, after checking gains.
• Anytime control results or moving averages are out of range and
verification confirms that the out-of-control condition is instrument
related.
The ADVIA 360 Hematology System calibration process consists of running
a commercial calibrator material or a human whole blood sample with
known parameter values multiple times. The known parameter values and
the average values of multiple runs are used to calculate calibration
factors. The new calibration factors take effect once the factors are
accepted by the operator.
If you are using a human whole blood as a calibrator, measure the
calibration target values on a reference analyzer according to applicable
regulations, standards, or laboratory procedures.
Calibration is required whenever the control values are out of range.

Viewing or Modifying Calibration Factors

1. On the Home screen, select Maintenance > Calibration > Factors.
2. Tap the field of a factor and manually enter a new value using the
keypad.
3. After entering all calibration factors, tap Accept.
The system stores the new factors and generates a new event in the
calibration history log, with the current date and time. See Viewing
Calibration Events History.

Preparing to Run a Calibration

Prior to running a Calibration, run a Self-test and a blank measurement
with acceptable results:
1. On the Home screen, select Maintenance > Diagnostics > Self Test.
2. On the Home screen, select Measure > New Sample > Blank.

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Running a Calibration
1. On the Home screen, select Maintenance > Calibration > Calibration
with measurement.
2. Scan the barcode on the calibrator assay sheet to upload the lot
number, expiration date, and target values for the calibrator material.
If a barcode reader is not available, enter the values manually.

3. Select the Number of runs: 3 or 7.

4. Tap Accept.
5. Mix the calibrator material, insert the tube into the sample adapter and
tap Run.
6. If the results are within range and no warning flags display, tap Accept.
7. Select Run again until you reach the required number of runs, 3 or 7.
NOTE: Between runs, mix the sample thoroughly.
NOTE: If a warning flag displays (C or c, clogging), tap Discard to
delete that particular calibration run. Run Calibration with
Measurement again.
After performing all runs, the results display a statistical evaluation of
calibration results.
• Each calibration factor must be within 1.00 ± 0.20 limits.
• If a calibration factor is outside this range, the factor is highlighted
in red.
• The left area of the screen displays: Target values, Mean Values of
Runs, CV% (coefficient of variance), and the newly calculated
calibration factors.
8. If CV% values and the new factors are satisfactory, tap Accept.
If results are not acceptable:
1. Tap Cancel to discard the unacceptable calibration factors.
2. Repeat the calibration process using a new container of calibrator
material.
If results still are not acceptable, contact your local technical support
provider or distributor.

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Viewing Calibration Events History

On the Home screen, select Maintenance > Calibration > History.
The Calibration History screen displays the calibration factors generated by
each calibration.

Viewing the Calibration Database

On the Home screen, select Maintenance > Calibration > Database.
The calibration database screen displays the details of each calibration run.

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Diagnostics
The operator can view stored information about the system, perform
diagnostic procedures (self-test), and check the operational history of the
instrument (Statistics), set or check the status of the reagents.
On the Home screen, select Maintenance > Diagnostics.

Option Description
Device Information Displays the model, serial number, software
version, PIC version, and software compilation
date.
Statistics Displays the device statistics for measurement
cycles, errors, and other information for use by
service personnel.
Self test Initiate a self test to test the key functions and
components of the analyzer. This process takes
approximately 1 minute.
Run Self-test:
• After installation
• After replacing any component
• After extended time not in use
• When you suspect that the system is not
giving reliable results.

When the Self-test completes, the system displays

a summary of the results. The results must fall
within the ranges specified by the min. and max.
values.
To save the results, insert a USB storage device
and tap Save.
NOTE: If any of the self-test parameters fail,
contact your local technical support provider or
distributor representative.

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Reagent Status
This menu monitors reagents, sets up and checks lot numbers, expiration
dates, and actual levels.
There are individual sensors for the 3 reagents. Turn the sensors on or off
by moving the Sensor icon left or right.
On the Home screen, select Maintenance > Reagent status and select an
option:

Reagent option Description

Prime The prime option for each reagent; initiates a
priming for that particular reagent.
Prime all Select Prime all to prime all 3 reagents.
Waste After disposing of the contents of waste
container, tap Empty Waste to reset the waste
counter to 0%.
The waste and reagent level % calculation is based
on the setting of the tank capacity. Use the
Volume key to set the capacity of the containers.
Waste tracking ON/ • If the system empties directly into a drain, set
OFF Waste tracking to OFF.
• If the system empties into a waste container
set Waste tracking to ON.
Empty waste Resets the waste counter if waste tracking is ON.
Sets the waste counter to 0%.
Replace Use this option when replacing Reagents.
NOTE: The waste and reagent level% calculation
is based on the setting of the tank capacity.
View log Shows reagent replacement history.
Measurement credits Shows the measurement credit counter.
For more information, see Displaying
Measurement Credits in this chapter.

Reagent Sensor Error

If a reagent sensor error message displays, run Calibrate Sensors.

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Replacing Reagents
1. On the Home screen, select Maintenance > Reagent status.
2. Tap Replace.
3. Tap the Reagent Type field, and select the reagent to be replaced from
the drop-down list.
4. Type the Lot number and the Expiration date or scan the barcode.
NOTE: If you are replacing ADVIA 360 Lyse 3P Diff (1L) insert the
reagent hardware key into the key slot on the back of the system.
5. Tap Accept.

Reagent Lock System and the HW Key

The measuring system and analysis software work with
Siemens Healthineers reagents. The reagent lock feature allows only
Siemens Healthineers reagents to be used, thereby ensuring accurate
results. Siemens Healthineers cannot guarantee optimal performance of
the ADVIA 360 Hematology System with incompatible reagents.
When the number of measurement credits reaches 0 (zero), the system
cannot perform measurements. This error message displays:
Error 6001
No more measurements allowed!
NOTE: Each measurement cycle decreases the number of measurement
credits by one, except for initialization, standby, and wake-up cycles which
do not affect the measurement credits.
To restore measurement credits, you must obtain a new reagent hardware
key and insert the key into the HW Key reagent slot.

Figure 11: Reagent Hardware Key

Each ADVIA 360 Lyse 3P Diff (1L) reagent comes with a hardware key
containing 900 measurement credits.

Displaying Measurement Credits

1. On the Home screen, select Maintenance > Reagent status.
2. Tap Measurement credits.
The measurement credits on the system and on the reagent hardware
key display.

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Loading Measurement Credits from a Hardware Key

Replace the reagent key before replacing the ADVIA 360 Lyse reagent
container.
1. Remove the old reagent key from the reagent lock slot located on the
back of the instrument.
2. Remove the hardware key from the zip bag of a new ADVIA 360 Lyse 3P
Diff (1L) reagent.
3. Insert the hardware key into the key connector on the back of the
system. (See Figure 12 .)
The gold contacts of the key face down.
NOTE: Do not insert the hardware key into a USB port. The
ADVIA 360 Hematology system cannot read the hardware key that is
inserted into a USB port.

Figure 12: Installing the Hardware (HW) Key

4. Replace the ADVIA 360 Lyse reagent container.

5. On the Home screen, select Maintenance > Reagent Status.
6. Tap Replace at the bottom of the screen.
7. In the Reagent Type field, select Lyse-DIFF.

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8. Tap Accept.
The new license for 900 measurement credits uploads to the system
and the counter resets.
NOTE: Dispose of the hardware key according to local laws or regulations
governing the disposal of electronic materials or collect the keys for your
distributor or local service provider for recycling.
If you do not insert a key when the system reaches zero credits, or if a used
key is inserted, or a key that is not compatible with your particular system,
this error message displays:
Error 6003
Hardware key not found, or is not suitable for this
device! Please connect a proper hardware key!
If this error message displays, insert a new key and tap Retry.
Credit counting is linked to lyse reagent in the system; however, a small
amount lyse remains in the reagent container when the counter gets to
zero (0) to ensure that enough lyse is available if extra maintenance is
required.

Liquid Sensors
The ADVIA 360 Hematology System has 4 liquid sensors.
• Diluent
• Lyse
• Cleaner reagent
• The fourth sensor is built into the sampling head and checks aspiration
of the blood sample. If this sensor detects bubbles during sampling, an
error message is displayed after measurement.

Troubleshooting Sensors
The two most common sensor problems are micro-bubbles and blockages.

Issue Maintenance Operation

Micro-bubbles in the tubing Check the tubing connections at the
reagent container connections and the
reagent tubes and at the back of the unit.
Reconnect the tubing.
Dried or accumulated When this type of blockage occurs, a
contamination in a position sensor incorrectly detects liquid.
that blocks the sensor.
1. Perform a hard cleaning to remove the
blockage.
2. Run a sensor calibration.

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Viewing or Saving the Reagent Log History

1. On the Home screen, select Maintenance > Reagent status.
2. On the Reagent status screen, tap View log.
3. Tap Filter and select which reagents to display in the log.
4. Tap Export to save the Reagent change log on a USB storage device.
5. Name the file: reagent_tracking.csv and save in ASCII format.
Use Microsoft Excel to open this log file.

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6 Troubleshooting

The ADVIA 360 Hematology System performs all the maintenance

functions required to keep the system running optimally. The system can
encounter problems that require operator intervention.
The system displays error messages when a condition exists that requires
attention.

Error Messages
Error message codes help to identify the cause of an error. The codes are
important for service personnel who can interpret the codes and take
necessary actions.
If an error message with a numerical code displays, record the message
and describe the operation you were performing before the error occurred.
This information helps the service engineer diagnose the problem. The
system stores and displays every error message, but additional information
you provide helps with troubleshooting.
When an error occurs, the software usually offers a solution and requests a
retry of the operation. If this recovery process fails, or if the problem
persists, contact your support provider or distributor representative.

Mechanical Problems
The system is designed to be error-tolerant and recover from minor
problems. However, some physical obstructions and extreme operating
conditions can cause a mechanical part to behave unexpectedly. In such
cases the system displays an error message.
Problems caused by severe blockages are often accompanied by a grinding
noise. The noise is generally a motor unsuccessfully attempting to turn, but
this does not usually result in mechanical damage to moving parts.

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BIOHAZARD
All products or objects that come in contact with human blood, even after
cleaning, should be handled as if capable of transmitting infectious
diseases. Wear facial protection, gloves, and protective clothing. Refer to
Protection of Laboratory Workers from Occupationally Acquired Infections;
Approved Guideline–Third edition, (2005), Document M29-A3,
promulgated by the Clinical and Laboratory Standards Institute (CLSI), for
information about user protections when working with biohazardous
material.

WARNING
Do not perform maintenance inside the system unless the system is
stopped. Mechanical parts can move and cause injury.

Sample Rotor Issues

Issue and Description Additional Information
Sample tube is too tall. 1. Use an approved sample tube.
If the sample tube is too tall, this 2. Place the sample tube in the
causes the tube to hit the front correct adapter.
cover.
3. Replace and Retry operation.
An incorrect sample adapter is
used with the sample tube.
The opening on the front is not 1. Open the door and check the
aligned with the sample rotor wash head for contamination
door. (blood and salt).
Excessive salt build up can
prevent the wash head from
lifting up effectively and the
sample rotor door can get
stuck.
2. Perform wash head cleaning.
See Chapter 5, Weekly Maintenance.

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Needle Mechanics, Vertical Motor (MVert) Issues

WARNING
Do not shut down the system by pressing the power switch on the rear
panel without initiating Shutdown from the Home Screen. Powering off
using only the rear panel power switch can result in erroneous operation,
loss of data, or a prolonged start-up cycle during subsequent use of the
system.

BIOHAZARD
All products or objects that come in contact with human blood, even after
cleaning, should be handled as if capable of transmitting infectious
diseases. Wear facial protection, gloves, and protective clothing. Refer to
Protection of Laboratory Workers from Occupationally Acquired Infections;
Approved Guideline–Third edition, (2005), Document M29-A3,
promulgated by the Clinical and Laboratory Standards Institute (CLSI), for
information about user protections when working with biohazardous
material.

WARNING
Do not perform maintenance inside the system unless the system is
stopped. Mechanical parts can move and cause injury.

Issue Description Additional Information

Sampling depth is not set correctly See Supported Sample Tube Types.
for the sample tube used.
Needle in wash head does not Salt build up or a thick salt layer can
move. block the movement.
Perform a wash head cleaning.
See Weekly Maintenance.
Wash head does not move or wash Salt build up or a thick salt layer can
head is blocked. block the movement.
Perform a wash head cleaning.
See Weekly Maintenance.

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Issue Description Additional Information

The piercing needle is bent or the Contact your technical support
needle is not set or is misaligned. provider or distributor.
The vertical rod holding the needle Remove the blockage or contact
carriage is blocked. your technical support provider or
distributor for assistance.

Needle Mechanics, Horizontal Motor (MHori) Issues

WARNING
Do not shut down the system by pressing the power switch on the rear
panel without initiating Shutdown from the Home Screen. Powering off
using only the rear panel power switch can result in erroneous operation,
loss of data, or a prolonged start-up cycle during subsequent use of the
system.

BIOHAZARD
All products or objects that come in contact with human blood, even after
cleaning, should be handled as if capable of transmitting infectious
diseases. Wear facial protection, gloves, and protective clothing. Refer to
Protection of Laboratory Workers from Occupationally Acquired Infections;
Approved Guideline–Third edition, (2005), Document M29-A3,
promulgated by the Clinical and Laboratory Standards Institute (CLSI), for
information about user protections when working with biohazardous
material.

WARNING
Do not perform maintenance inside the system unless the system is
stopped. Mechanical parts can move and cause injury.

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Issue Solution
The piercing needle is bent or the Contact your technical support
needle is not set or is misaligned. provider or distributor.
The horizontal driving rod holding Remove the blockage.
the needle carriage is blocked. Contact your technical support
provider or distributor for
assistance.

Dilutor Errors

BIOHAZARD
All products or objects that come in contact with human blood, even after
cleaning, should be handled as if capable of transmitting infectious
diseases. Wear facial protection, gloves, and protective clothing. Refer to
Protection of Laboratory Workers from Occupationally Acquired Infections;
Approved Guideline–Third edition, (2005), Document M29-A3,
promulgated by the Clinical and Laboratory Standards Institute (CLSI), for
information about user protections when working with biohazardous
material.

WARNING
Do not perform maintenance inside the system unless the system is
stopped. Mechanical parts can move and cause injury.

Issue and Description Additional Information

Pinched or clogged tube around Check for free flow of reagents.
the diluter or at the rear reagent
tubes.
Physical obstruction (foreign Remove any obstructions.
material) present in the tubing.

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Priming Issues – Reagent Warnings

BIOHAZARD
All products or objects that come in contact with human blood, even after
cleaning, should be handled as if capable of transmitting infectious
diseases. Wear facial protection, gloves, and protective clothing. Refer to
Protection of Laboratory Workers from Occupationally Acquired Infections;
Approved Guideline–Third edition, (2005), Document M29-A3,
promulgated by the Clinical and Laboratory Standards Institute (CLSI), for
information about user protections when working with biohazardous
material.

WARNING
Do not perform maintenance inside the system unless the system is
stopped. Mechanical parts can move and cause injury.

Issue Description Additional Information

Out of reagent Replace reagent.
Tubing on a reagent container is Reattach the tube.
disconnected.
Tubing on a reagent container is • Straighten the tube and
bent. remove the blockage
• Replace the tube.
Tubing on a reagent container • Trim a piece of the tubing from
has a leak or is broken. the end and reconnect the
reagent lines.
• Replace the tube.
A tube inside the system is 1. Open the side door and look for
disconnected. the open tube.
2. Reconnect the tube to the valve
or tubing connection.
A tube inside the system is • Look for leakage, or salt traces
damaged. of liquid.
• Contact your local support
provider or distributor.

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Touchscreen does not Work

1. Check the screen for moisture.
Moisture on the screen glass can interfere with touch operation.
2. Power-off the system.
3. Clean the screen with a lint-free tissue, damp with 5% sodium
hypochlorite solution.
NOTE: Using this solution can lighten color over time.
4. Wipe the screen completely dry.
5. Power on the system and retry the touchscreen.
If the problem persists, contact your support provider or distributor.
If these steps do not resolve the issue, connect an external USB mouse. You
can use an external mouse to select screen elements.

System Does Not Power On

• Ensure all the power connections are functioning (wall outlet, power
supply, and the system power).
• Check the state of the power switch at the rear of the system.

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Problems Related to Measurement Results

See Chapter 3, Flags for information about warning flags.

Fluctuating PLT Background

Issue Description Additional Information
Blank PLT values are not Perform a Hard cleaning using Siemens
consistent, or increasing ADVIA 360 Hypoclean CC reagent.
unexpectedly See Chapter 5, Cleaning the System.
Measure a blank several times to ensure
that the system is clean and stable.
Stable but high PLT blank Reagents can be contaminated.
Load a new Diluent container.
When replacing a container, avoid cross-
contamination of the tubes:
1. Flush the tubes with tap water.
2. Clean the outside of the tubes using
a lint-free cloth dampened with
5% sodium hypochlorite solution.
3. Place the tubes in the new reagent
container.
The PLT blank should be low and
acceptable.
PLT blank fluctuates Check the area around the system for a
device that radiates electromagnetic
noise.
Relocate the ADVIA 360 Hematology
System if you suspect that electronic
interference is causing a high PLT blank.
NOTE: Proper electrical grounding is
essential for stable, background-free
operation.

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7 Data Management

Database Operations
Patient results are stored in system memory and can be viewed in the
database at any time.
Memory capacity is 10,000 patient records, including all parameters,
histograms, flags, sample ID, and date/time of measurement.
If storage space is full, the latest record overwrites the oldest record in the
database.

Database Navigation
Select all of the records in the database by tapping the check box at the top
of the Database screen —the check box to the immediate left of words
Patient ID. This check box is a toggle—tapping the check box again
deselects any record that is currently selected, even a record that is off-
screen (scrolled out of sight). The top check box is checked if at least 1
record is selected.
As you scroll through a large database, this check box remains selected
even if you have only 1 record selected.

Viewing Records in the Database

1. On the Home screen, select Database.
2. In the Database screen, tap the check box of the record to view.
3. Tap Details.
4. Tap an option: Parameters, Normal Ranges, or Tech Details.

Filtering and Viewing Database Records

1. On the Home screen, select Database.
2. Tap Filter.

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3. On the Results filter screen, type the data criteria by which you want to
filter.

Filter by Action
Date from The default setting for the date is the current date.
The date must be in the format setup by the system’s
administrator. The system automatically adds the
forward slash (/) to separate the days, month, and years.
Tap Enter on the keypad.
Date to
Patient ID Type and tap Enter on the keypad.
Sample ID
Type Select one of the 10 profile types, or Control, or Blank, or
All.
Records Siemens Healthineers recommends using Selected,
otherwise the filter runs against the entire database,
providing too many results.

Restore default settings or delete all dates by tapping Clear.

4. Tap Filter.
Records that match your filter criteria display.
5. To filter the initial results tap Filter again and select (or type) further
criteria.
Select records from the filtered results by tapping the check box next to
the Patient ID of the desired records.
6. The Statistics option and Print option are enabled to view stats or print
filtered, selected records.

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Calculating Statistics for Selected Records

The system calculates statistics (SD, CV, Levey-Jennings chart, mean
values) for 2 or more selected records. If you do not select 2 or more
records the Statistics option is grayed-out.
1. On the Home screen, select Database.
2. Select the records to include in the statistics calculation by tapping the
check box next to the record.
3. Tap Statistics.
The Levey-Jennings charts for the selected records display.
4. Navigate through the charts and data points using the arrows on either
side of the View option.
5. Tap View to display the Parameters, Normal Ranges and Tech Details.

Viewing Database Records Details

1. On the Home screen, select Database.
2. Tap the check boxes next to the records you want to view.
3. Tap Details.
4. To view the details for Parameters, Normal ranges, and Tech Details,
tap that particular option.

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Managing Selected Records in the Database

Deleting Records
1. On the Home screen, select Database.
2. Select a record by tapping the check box next to a record.
3. Tap Manage.
4. Select Delete to remove a record
5. Select Yes to confirm.
Deleted records cannot be restored.

Sending Records
If a hardware connection exists between the system and the external PC or
network, you can select records to transmit to an external computer or
laboratory information system (LIS). Select one of the following to transmit
information:
1. On the Home screen, select Database.
2. Select the records by tapping the check box next to a record.
3. Tap Manage.
• Select PC to transmit selected records to a PC through an Ethernet
channel.
• Select Electronic Medical Record (EMR) to upload the selected
record to a PC or LIS connected via Ethernet port.
• Select USB-Serial to use PC link via the USB-B port connection, and
serial communication protocol.
Note If the options to send records are active in Settings, you can
select the method by which records are transmitted even if the
connection type has not yet been configured. See Chapter 8, System
Configuration Settings.

Backing Up Selected Records

The Back-up options displays selected records that can be saved in different
file formats. These records can be saved onto a USB storage device
connected to the system
1. Before performing a backup, insert a USB storage device into a USB
port.
2. On the Home screen, select Database.
3. Tap the check box for the selected record.

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4. Tap Manage > Backup.

5. Tap a Backup option:
Backup option Function
Save Saves selected records in.db format. Data saved in
this format can be viewed using Backup view.
NOTE: Wait until the save operation completes
(progress bar finishes). When the USB storage
device is no longer flashing, remove the drive from
USB port to avoid data loss.
Export Exports selected records as an ASCII file (.txt). In this
format, data can be easily imported into Microsoft
Excel and other programs.
See Chapter 8, System Configuration Settings to
learn about setting up the format of the text
exported to file.
Backup view Opens a .db format data files previously saved onto
a USB storage device. See the Viewing Back Up
Records for more information.
Backup one day Allows you to backup data records for a specific day
(.db format).

Viewing Back Up Records

1. Insert the USB storage device containing saved data records (.db file
format).
2. On the Home screen, select Database > Manage > Backup > Backup
view.
3. Select the database file to view and tap OK.
4. View individual records by tapping Details.
Records loaded from the USB storage device can be viewed, printed,
transmitted, filtered, managed, just as for normal database records. See
Data Management for details on database functions.

Printing records for a single day (Backup one day)

1. On the Home screen, select Database.
2. Select records to print by tapping the check boxes next to the records.
3. Tap Print.
• Select Result by result to print in normal report format.
• Select Table format to print a summary of records without
histograms.

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Print Job Errors

If a print job has started but did not finish because of an error (for example,
the connection to the printer was lost or the printer is out of paper), the
system displays an error icon (an exclamation mark) in the header.
1. Tap the error icon (exclamation mark) in the screen header.
The Print Jobs screen displays the printer status and print jobs that are
pending.
• Select Abort to cancel the current printing job
• Select Abort All to delete all print jobs from the queue.

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8 System Configuration Settings

General Settings
1. Select Home > Settings > General Settings.
2. In General Settings, tap a field to change a setting.

Field Setting Description

Sound Turns on or off system beeps and other notification
sounds.
Language User interface Language. Opens a window to select a
language.
Export format Select the format data transmission.
• Simple text: Results only
• Advanced text: Results and ranges only
• Extended text: Results with histograms and
ranges
Barcode • Select Disabled if a barcode reader is not
connected to the system.
• Select Patient ID if a barcode reader is used only
for patient IDs.
• Select Sample ID if a barcode reader is used only
for sample IDs.

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Communication Settings
Setting Up Networking
1. On the Home screen, select Settings > Communication >
Device Communication.
The current settings display.
2. Tap a field to change the setting.

Field Setting Description

DHCP If Enabled, the master device on the local network
assigns an IP address for the system.
IP address If DHCP is Disabled, enter a valid IP address.
Contact your network administrator for a valid IP
address.
Subnet mask Typically set to 255.255.255.0
If DHCP is Disabled, contact the your network
administrator for the subnet mask.
Gateway Typically set to 0.0.0.0
DNS Typically set to 0.0.0.0

Setting Up Peer Communication

1. On the Home screen, select Settings > Communication >
Peer Communication.
2. Tap a field to change the setting.
NOTE: Contact your technical support provider or the LIS administrator for
more information on these settings.

Field Setting Description

PC If a PC is connected to the system, select Active.
PC remote IP address If PC setting is Active, enter a valid network
address so the system can send data to an LIS.

NOTE: The interface enables you to enter an IP

address even if the PC setting is set to Inactive.
This enables you to store a valid IP address for
later use. For example, if you set the PC setting
to Active at a later time.
EMR Set to Active if the system must receive work
lists.

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Field Setting Description

EMR remote IP If EMR setting is Active, enter a valid network
address address, otherwise the system cannot send or
receive work lists.
EMR local port Enter the local port number on which the system
receives work lists from a local device.
USB-Serial link If a PC is connected using the USB-B port, enable
this setting.
USB-Serial Baud Rate To connect a PC using a USB-B emulated serial
link, set the baud rate to that of the connected PC
serial baud rate.
Automatic send After a measurement completes, select a port to
send the data record automatically:

• PC only: Records sent to a PC connected by

the LAN port
• EMR (LIS) only: Records sent to an LIS
address through a LAN
• PC and EMR(LIS): Records sent to both
addresses through the LAN (Ethernet) port
• USB-Serial: Records sent through the USB-B
port to a PC.
The default, Disabled, means that no records
automatically transmit.

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Measurement Settings
Setting the Units of Measured Parameters
1. On the Home screen, select Settings > Measurement > Units.
2. Select the unit type for Count and HGB.

Unit Measurement Type

Count Tap to select:
• cells/μL
• cells/L
HGB Tap to select:
• g/dL
• g/L
• mmol/L
PCT/HCT Tap to select:
• %
• absolute

Setting Normal Ranges for Measured Parameters

Normal ranges can be set for Human, Male, Female, and all other Profiles.
1. On the Home screen, select Settings > Communication >
Measurement > Normal ranges.
2. Tap the field for which you want to enter or change data.

Renaming a Profile (1–7)

1. On the Home screen, select Settings > Communication >
Measurement > Normal ranges.
2. Tap the Type field and tap the Profile to rename.
3. Tap Rename.
4. Type a new name and tap Enter.

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Printer Settings
Selecting Printer and Paper Settings
On the Home screen, select Settings > Printer > Device.

Field Setting
Printer Select the printer connection:
• USB port
• Built-in
Mode Black & White or Color
Paper A4 or Letter
Top margin Enter the distance from the edge of paper from
where printing should begin.
Automatic printing If enabled, the ADVIA 360 Hematology System
automatically prints all results after each run.

Modifying Report Content

On the Home screen, select Settings > Printer Setting > Format.

Field If Enabled
Limits Normal ranges are printed.
Warnings Warning flags are printed.
Technical information Lyse volume and probe voltages are printed.
Diagnostic flags Diagnostic flags are printed
Logo ADVIA 360 Hematology System Logo appears
on the print-outs.
Histogram WBC, RBC, and PLT histograms are printed.

Modifying Report Headers

1. On the Home screen, select Settings > Printer Setting > Format.
2. Locate Laboratory headers.
3. In the Laboratory header fields, enter text to be printed in the headers
of each report page.
For example, Header lines 1–2 can contain the name of the lab and the
address. Header lines 2–4 contain a contact name and telephone
number.

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Date and Time Settings

Changing the System Date and Time
On the Home screen, select Settings > Communication > Measurement >
Date and time.

Setting Description
Date Enter current date in the Date format.
Time Enter current time, and tap Enter.
Date format • Day/Month/Year
• Month/Day/Year
• Year/Month/Day
Time format 12-hour or 24-hour

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Appendix A: Safety Information

This section provides information about biohazards and safety resources.

This summary is for general information only. This information does not
replace or change laboratory or hospital biohazard control procedures.
A biohazardous condition is any situation involving infectious, biological
agents, such as the hepatitis B virus, the human immunodeficiency virus,
and the tuberculosis bacterium. These infectious agents may be present in
human blood, blood products, and other bodily fluids.
Dispose of hazardous or biologically contaminated materials according to
the practices of your institution. Discard all materials in a safe and
acceptable manner and in compliance with prevailing regulatory
requirements.

General Precautions
Read this section carefully before operating the ADVIA 360 Hematology
System.

BIOHAZARD
All products or objects that come in contact with human blood,
even after cleaning, should be handled as if capable of transmitting
infectious diseases. Wear facial protection, gloves, and protective
clothing.

BIOHAZARD
The sampling needle and other components inside the system may
cause injury, or can get damaged if handled incorrectly. Only
certified personnel should open the covers. Running samples with
opened cover is not recommended due to the risk of possible injury.
Always wear safety gloves while performing maintenance actions.

The system operates with chemically and biologically active reagents.

Physical contact with these reagents should be avoided. Read reagent
descriptions and MSDS carefully for possible emergency actions.
To ensure reliable operation and reliable results:
• Only analyze human blood samples.
• Only use Siemens reagents.

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Safety Information ADVIA 360 Hematology System

• Perform the required maintenance as detailed in this operator’s guide.

• Only Siemens Healthineers certified service personnel should perform
service actions.
• Only use Siemens Healthineers service materials and spare parts.
• Only Siemens Healthineers certified service personnel that have
successfully completed the Siemens Service Training program are
qualified to service the ADVIA 360 Hematology System.
• Before operating the ADVIA 360 Hematology System, all operators
should complete an ADVIA 360 Hematology System Operator Training
program. This program is offered by your distributor or local service
provider.
Waste contains poisonous substances (because of chemical content) and
human origin substances meaning biohazard. These substances are
representing potential danger to environment. For this reason, safe
handling of the waste liquid is very important.
Replacement materials or spare parts (tubes, valves, etc.) that might have
been in contact with human blood or reagents should be handled as a
potentially biologically hazardous and chemically dangerous material. All
local laws and regulations must be observed in the handling and disposal
of these materials.
The ADVIA 360 Hematology System is designed for laboratory operation.
Mobile operation is not supported. Operate the system within the ambient
temperature range described in Appendix D, Specifications.
This IVD equipment complies with the emission and immunity
requirements described in relevant part of the IEC 61326 series.
This equipment has been designed and tested to CISPR 11 Class A. In a
domestic environment, the equipment may cause radio interference, in
which case, you may need to take measures to mitigate the interference.
Electromagnetic environment should be evaluated prior to operation of the
device.
This system contains electronic components. Handle electronic waste
adhering to local or federal regulations.

Serious Incident Reporting

According to EU regulation 2017/746, any serious incident that has
occurred in relation to the device shall be reported to the manufacturer
and the competent authority of the EU Member State in which the user
and/or patient is established.

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Electrical Safety

ELECTRICAL HAZARD
Do not operate the system without a protective grounding connection
that prevents electrical shock. Electrical shock can cause equipment
damage and bodily harm.
Use caution when working around these locations or contact a local
technical support provider for more information about using a protective
grounding connection and avoiding electrical shock hazards.

ELECTRICAL HAZARD
Do not perform system maintenance procedures that require the power
to be off without powering off the system. Performing these procedures
with the system powered on can result in exposure to shock hazards or
system damage.

CAUTION
Do not place any objects that interfere with access to the power
connection. Interference can damage the electrical cord or provide
intermittent power to the system and prevent access to the system’s
main power disconnect.

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Emergency Situations
Always follow all applicable laws and regulations regarding emergency
situations. An emergency shutdown of the system can sometimes be
required:
• When there is a risk of personal injury
• If there is a fire or flood in the laboratory
• If the wrong reagent is connected to the system
• When there is a risk of high voltage on the electric grid such as in a
lightening storm

ELECTRICAL HAZARD
In case of fire or electrical arcing, disconnect the ADVIA 360 Hematology
System power cord. Do not use water to extinguish the fire unless the
ADVIA 360 Hematology System is disconnected from the electrical power
network. Using water to extinguish the fire can result in electric shock.

In an emergency situation, disconnect the main power cable from the

outlet, or turn off the main switch. In case of an electrical risk, turn-off the
power from the external power supply unit — do not use the main switch.
Use a fire extinguisher with the correct classification, if necessary.

Moving and Storing the System

Move the system in an upright position.
Retain the original packaging material for safe transportation and storage
in the future.
To prepare the system for shipping, storage or extended periods of
inactivity, drain the reagents, decontaminate, and repackage the system in
the system’s original packaging.
Store the ADVIA 360 Hematology System within the temperature range
of 5–35°C (41–95°F). Do not expose the system to direct sunlight or to
extreme high or low temperatures, or humidity over 85%. If the system
was subjected to extreme temperatures during shipment or storage, the
system must be placed in a room whose temperature is within the
operational range for at least 1 hour before installation or use.

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Reagent Warnings and Precautions

When working with Siemens reagents, follow the warnings and
precautions associated with that particular reagent.

Reagent and Symbol GHS Codes Description

Ordering Code
ADVIA 360/560 Dil 20L Warning!
H317 Can cause an allergic skin reaction.
SMN (11170845) P280 Wear protective gloves/protective
clothing/eye protection/face
protection.

P302+P352 IF ON SKIN: Wash with plenty of soap

P333+P313 and water. If skin irritation or rash
occurs, get medical attention.

P501 Dispose of contents and container in

accordance with all local, regional,
national, and international
regulations.
P272
Do not allow contaminated work
clothing out of the workplace.

Contains 5-chloro-2-methyl-3(2h)-
isothiazolone mixture with 2-methyl-
3(2h)-isothiazolone
ADVIA 360/560 H319 Warning!
Hypoclean CC 100 mL
H315 Causes serious eye irritation. Causes
for hard cleaning
skin irritation. Wear protective
P280 gloves/protective clothing/eye
SMN 11170851 P264 protection/face protection. Wash
hands thoroughly after handling.

P305+P351+ IF IN EYES: Rinse cautiously with

P338 water for several minutes. Remove
contact lenses, if present and easy to
do so. Continue rinsing.

Contains sodium hydroxide

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Safety Information ADVIA 360 Hematology System

Safety References
Biohazard Safety Resources
1. CDC. Update: universal precautions for prevention of transmission of
human immunodeficiency virus, hepatitis B virus and other blood
borne pathogens in health-care settings. MMWR, 1988; 37:377–382,
387, 388.
2. Clinical and Laboratory Standards Institute (formerly NCCLS).
Protection of Laboratory Workers from Occupationally Acquired
Infections; Approved Guideline—4th ed. CLSI Document M29-A4. [ISBN
1-56238-961-0]. Wayne, PA: Clinical and Laboratory Standards
Institute, 2005).
3. Federal Occupational Safety and Health Administration. Bloodborne
Pathogens Standard. 29 e-CFR 1910. 1030.
4. IEC 61010-2-101:2015. Safety requirements for electrical equipment
for IEC measurement, control, and laboratory use. Part 2-101:
Particular requirements for in-vitro diagnostic (IVD) medical
equipment. Geneva, Switzerland.
5. IEC 62471:2006 Photobiological safety of lamps and lamp systems,
Geneva, Switzerland.

Barcode Scanner Safety Resources

1. IEC 61010-2-101:2015. Safety requirements for electrical equipment
for IEC measurement, control, and laboratory use. Part 2-101:
Particular requirements for in-vitro diagnostic (IVD) medical
equipment. Geneva, Switzerland.
2. IEC 62471:2006 Photobiological safety of lamps and lamp systems,
Geneva, Switzerland.

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Appendix B: Warranty and Support
Information

Warranty
About Limited System Warranty and Service Delivery
Policy
Siemens Healthineers and its authorized distributors may provide
customers who acquire new Siemens Healthineers systems with a limited
warranty either in a specific agreement or standard language on their
invoices. This limited warranty is designed to protect customers from the
cost associated with repairing systems that exhibit malfunctions due to
defects in materials and/or workmanship during the warranty period.
Siemens Healthineers, at its election, provides warranty service either by
providing repair service of the system on site, or by exchanging the
defective system or component, subject to the limitations and exclusions
set forth in Replacement of Parts and Warranty and Service Exclusions
Repairs, replacements, or exchanges of systems or components provided
during the warranty or any additional service period, do not extend the
warranty or service period beyond the initially agreed upon period.
When the customer calls for service, the representative or authorized
distributor informs the customer of the type of service available for the
customer’s system, and instructs the customer how to obtain that service.

About the Warranty Period

The limited warranty period generally commences upon installation of the
original system at the customer’s location and extends for a period of
1 year thereafter, unless otherwise specifically agreed upon between
Siemens Healthineers (or its authorized distributors) and the customer in a
writing signed by duly authorized representatives of both parties (sales
representatives are generally not authorized representatives of
Siemens Healthineers for these purposes).

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Warranty and Support Information ADVIA 360 Hematology System

Support Information
For technical assistance, contact your local technical support provider. For
customer service or additional information contact your local support
provider or distributor.

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Appendix C: Orderable Supplies

Reagents
Use only the reagents listed in Table 3. All these reagents are for in vitro
use only. Open bottle stability for these reagents is:
• ADVIA 360 Lyse 3P Diff – 90 days
• ADVIA 360/560 Dil – 60 days
• ADVIA 360 Cleaner 1L – 90 days
Reagent storage temperature: 15–30°C (59–86°F).

WARNING
Wear suitable eye, face, and skin protection, which includes wearing
gloves, protective eye shield, and laboratory coat. In case of contact with
the eyes, rinse the eyes immediately with plenty of water and seek
medical advice. In case of accident or if you feel unwell, seek medical
advice. If possible, show the bottle label and the Material Safety Data
Sheet. In case of accidental ingestion of reagent, call a physician
immediately.

Siemens Healthineers is not responsible for the performance and lifespan

of the ADVIA 360 Hematology System when reagents other than those
supplied by the manufacturer are used.

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Table 3: ADVIA 360 Hematology System Reagents

Reagent Type and Ordering Color Code Description

Ordering Code Code (SMN) & Shelf Life
ADVIA 360/560 Dil 20L 11170845 Green An isotonic, filtered saline
solution is used to dilute
3 years
whole blood samples and
rinse the fluidic system
between measuring cycles.
The solution is connected to a
dedicated diluent input at the
rear of the system.
ADVIA 360 Lyse 3P Diff 11170848 Yellow Lyse reagent is connected to
1L the rear reagent input.
4 years
The Lyse reagent creates
hemolysate for 3-part WBC
differential, total WBC count
and HGB determination.
The reagent key attached to
the bottle in a plastic bag
contains 900 measurement
credits.
ADVIA 360 Cleaner 1L 11170849 Dark Blue Cleaning solution of the
fluidics, connected to the
4 years
dedicated rear reagent input.
The system uses this reagent
to clean the tubing, counting
chambers and apertures.
ADVIA 360/560 11170851 15 months Used for Hard Cleaning
Hypoclean CC 100 mL procedure to remove protein
for Hard cleaning and lipids from sample tubes,
chambers, and apertures.
This reagent should be
dispensed into a sample tube,
before starting a Hard
cleaning.
ADVIA 360/560 11170852 Used for calibrating the
Calibrator system to ensure accuracy.

For reagent consumption information, see Appendix D, Reagent

Consumption.

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Approved Controls and Calibrator

Hematology controls and calibrator are used to check precision, accuracy,
and to calibrate the system.
ADVIA 360 Hematology System control and calibrator materials are the
validated products to use with the ADVIA 360 Hematology System:

Table 4: Approved Controls and Calibrator

Material Purpose Reagent Type and

Ordering Code
Control material (low, Checking performance of ADVIA 360
normal, high levels) the ADVIA 360 Hematology System
Hematology System Control Set
SMN 11170853
Calibrator material Performing calibration of ADVIA 360/560
the ADVIA 360 Hematology System
Hematology System Calibrator
SMN 11170852

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Orderable Supplies ADVIA 360 Hematology System

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Appendix D: Specifications

System Specifications
Item Description
Operating conditions Temperature: 15–30°C (59–86°F)
Optimal temperature is 20–25°C (68–77°F)
Relative humidity: 45–85% non-condensing
Analyzer operation at altitudes above 3000 meters
(9800 feet) is not guaranteed.
Storage conditions Temperature: 5–35°C (41–95°F)
Relative humidity: 15–90% non-condensing
Power supply unit External, auto-ranging power supply unit.
Input: 90-240 VAC, 47–63 Hz
Maximum input current: 6A at 90VAC, 3A at
240 VAC.
Output: 12 VDC, maximum 8.3 A, maximum 100 W
User interface Easy-to-use, user interface with a touchscreen
Data storage capacity 10,000 results with RBC, PLT, and 3-part diff. WBC
histograms
Host computer interface USB-B port (direct connection to host computer
through a USB port)
PC, LAN: Ethernet port on rear panel
Data back-up method USB storage device up to 16 GB.
Send data to LIS (Laboratory Information System)
Printer interface USB with support for most HP printer languages
(DeskJet, LaserJet, PCL3, PS, LIDIL)
Built-in printer Optional 58-mm thermal printer, monochrome
printout with histograms
Display 173 x 104 mm (8 inch), LED backlit,
color graphics LCD
External keyboard Optional, using an USB connection
Software upgrade method USB port using USB storage device (maximum 16 GB)
Sampling volume 100 µL of whole blood

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Specifications ADVIA 360 Hematology System

Item Description
Chambers 3 chambers for diluting whole blood and counting;
MIX, RBC, WBC
+1 needle-washing/draining chamber
Reagent system Isotonic diluent, Lyse, Cleaner
Aperture diameter 80 μm (RBC/PLT), 100 μm (WBC)
Throughput up to 60 tests/hour
Sampling method Open tube or closed tube system with automatic
sample rotor
Specimen types supported Human whole blood
Recommended sample collection K2- or K3-EDTA primary blood sample tubes,
method venipuncture
Sample identification method Individual sample ID entered by operator. Barcode
with external manual barcode reader
Sample types Control, Human, Male, Female (built-in reference
ranges), and Profiles 1–7 for additional operator-
defined ranges.
Clog prevention High-voltage pulse on apertures in each analysis
cycle; chemical cleaning; high-pressure back flush of
apertures.
Cleaning procedure High-voltage burst of the apertures, high-pressure
back-flush, chemical cleaning of the apertures.
Quality control Maximum 24 QC levels, QC parameters including:
number of runs, mean, ± range, SD and CV for all
measured and calculated parameters, Levey-Jennings
charts, separate QC database.
Calibration Automatic with 3 or 7 measurements, or manual
(factorial) calibration of WBC, HGB, RBC, PLT, and
MCV.
Dimensions (WxDxH) 316 x 492 x 360 mm
(12 7/16 x 19 3/8 x 14 11/64 inches)
Net weight 17.8 kg (39.24 lbs)

98 11170855 Rev. 03
ADVIA 360 Hematology System Specifications

Reagent Consumption
Reagent Consumption (mL)
ADVIA 360, ADVIA 360 ADVIA 360
Dil 20L Lyse 3P Diff Cleaner 1L
SMN 1L SMN
11170845 SMN 11170849
Function
11170848
Startup (initialize + 114.0 3.0 6.5
wake up)
Shutdown 54.0 0.0 4.6
Measure Blank 40.2 1.1 0.0
Measure Human 41.0 1.1 0.0
Measure Calibration 40.9 1.1 0.0
Measure QC 40.9 1.1 0.0
Prime Diluent 36.0 0.0 0.0
Prime Lyse 14.8 2.4 0.0
Prime Cleaner 19.3 0.0 2.0
Prime All 29.2 2.1 1.9
Standby 13.5 0.0 0.0
Wake up 0.9 0.0 0.0
Clean 49.8 0.0 4.6
Hard clean* 76.5 0.0 0.0
Self-test 11.4 0.0 0.0

*Hard cleaning cycle: 0.4 mL of ADVIA 360 Hematology System

HypocleanCC 100 mL. Preparing for shipment: 122 mL of DI water.

11170855 Rev. 03 99
Specifications ADVIA 360 Hematology System

Environmental Requirements
Operate the ADVIA 360 Hematology System within the ambient
temperature range of 15–30° C (59–86 °F) and a relative humidity range of
45–85%. Optimum operating temperature is between 20–25°C (68–77° F).
Store the ADVIA 360 Hematology System within the temperature range
of 5–35°C (41–95°F). Avoid exposing the system to direct sunlight or to
extreme high or low temperatures. If the system was subjected to extreme
temperatures during shipment or storage, the system must be placed in a
room whose temperature is within the operational range for at least 1 hour
before installation or use.
Store reagents at a temperature range of 15–30°C (59–86°F). Reagents
can tolerate temperature ranges of 5–35°C (41–95°F) for a maximum
of 3 days.

Electrical Requirements
The system should only be operated from a power (wall) outlet meeting
these power input requirements:
• Input voltage: 100–240VAC; 47Hz to 63Hz, maximum 100 VA.
• The system must be operated from its 12V power supply module.
• The system must be earth-grounded.
The ADVIA 360 Hematology System includes a power cord appropriate for
your power system. Use the appropriate power cord to ensure adequate
grounding of the system. If the power at your location is not reliable,
contact your representative for options such as installation of an external
UPS (uninterruptible power supply) module.

WARNING
Failure to properly ground the ADVIA 360 Hematology System bypasses
important safety features and can result in electrical hazard.

Do not place the ADVIA 360 Hematology System near potentially

interfering devices capable of emitting radio frequencies. For example,
radio or television transmitters, radars, centrifuges, X-ray devices, or fans.
The ADVIA 360 Hematology System is designed to be safe for transient
voltages to Installation Category II and Pollution Degree 2.

100 11170855 Rev. 03

ADVIA 360 Hematology System Specifications

Waste Disposal
The ADVIA 360 Hematology System waste contains human blood and
reagents that are chemically and biologically active, and should be
considered potentially infectious and a biohazard threat. Safe laboratory
practices must be followed including the use of personal protective
equipment (PPE) when operating the ADVIA 360 Hematology System and
handling blood, reagents, and waste.

BIOHAZARD
System waste contains poisonous substances (chemical content) and
substances of human origin that must be handled as a biohazard. These
substances represent an environmental danger that must be handled with
all the standard precautions and safeguards required by local laws,
regulations, and good laboratory practices.

Known Limitations
The ADVIA 360 Hematology System is not intended for analysis of animal
blood samples. Anti-coagulated and well-mixed human blood samples
must be free from contamination and clots.
Blood samples should be analyzed within 7 hours of venipuncture,
otherwise precision is not guaranteed, especially on WBC 3-part differential
parameters.

Performance Characteristics
Performance characteristics of the ADVIA 360 Hematology System are
listed sections below:
• Accuracy
• Precision
• Linearity
• Carry-over
• Sample Stability
• Reference ranges
• Interfering Substances

11170855 Rev. 03 101

Specifications ADVIA 360 Hematology System

Accuracy
Difference Criteria Evaluation Levels
Parameter Absolute Percent Low High
Range Range
WBC (103/µL) 0.30 6.00% 0.00 85.00
GRA% (%) 3.00 10.00% 0.00 100.00
LYM% (%) 3.00 10.00% 0.00 100.00
MID% (%) 3.00 10.00% 0.00 40.00
RBC (106/µL) 0.15 6.00% 0.00 8.00
HGB (g/dL) 0.30 6.00% 1.00 25.00
MCV (fl) 1.00 6.00% 50.00 120.00
RDW (%) 0.50 6.00% 8.00 20.00
PLT (103 /µL) 15.00 8.00% 0.00 1000.00
MPV (fl) 0.50 10.00% 5.00 30.00

Precision
Repeatability Within-Device Precision
Parameter SD CV% SD CV%
WBC (103/µL) < 0.18 < 2.7% < 0.40 < 4.0%
GRA% (%) < 3.5 < 8.0% < 3.5 < 8.0%
LYM% (%) < 3.1 < 8.0% < 3.1 < 8.0%
MID% (%) < 2.0 < 17.0% < 2.0 < 17.0%
RBC (106/µL) < 0.11 < 1.7% < 0.15 < 2.5%
HGB (g/dL) < 0.20 < 2.0% < 0.22 < 2.4%
MCV (fl) < 1.0 < 1.7% < 1.20 < 2.0%
RDW (%) < 0.4 < 2.5% < 0.45 < 3.0%
PLT (103/µL) < 23 < 6.0% < 27 < 7.0%
MPV (fl) < 0.45 < 8.7% < 0.5 < 10.0%

102 11170855 Rev. 03

ADVIA 360 Hematology System Specifications

Linearity

Param. Determination Nonlinearity Nonlinearity Reportable Reportable

(R2) absolute relative Low High
error error
WBC (103/µL) > 0.95 < 0.80 < 3.0% 0.95 83.45
HGB (g/dL) > 0.95 < 0.27 < 3.0% 1.4 23.7
RBC (106/µL) > 0.95 < 0.20 < 3.0% 0.44 7.74
3
PLT (10 /µL) > 0.95 < 35 < 3.0% 11 975

Carryover

Parameter Maximum Reportable Reportable

Carryover (%) Low High
WBC (103/µL) < 1.0% 0.95 83.45
HGB (g/dL) < 0.8% 1.4 23.7
RBC (106/µL) < 0.5% 0.44 7.74
3
PLT (10 /µL) < 1.0% 11 975

Sample Stability
Long-term sample stability studies on blood specimens drawn in K2- and
K3EDTA collection tubes at room temperature showed no significant
clinical variation for all parameters between 30 minutes and 7 hours post
phlebotomy. MPV results can show instability in the first 2 hours but are
stable afterwards.

11170855 Rev. 03 103

Specifications ADVIA 360 Hematology System

Reference Ranges

Male Female Human Units

Parameter Low High Low High Low High
WBC 4.0 11.7 4.0 11.7 4.0 11.7 (103 cells/
µL)
LYM% 10.8 45.4 10.8 45.4 10.8 45.4 %
MID% 1.8 17.0 1.8 17.0 1.8 17.0 %
GRA% 44.0 80.9 44.0 80.9 44.0 80.9 %
LYM 0.8 3.3 0.8 3.3 0.8 3.3 (103 cells/
µL)
MID 0.3 1.7 0.3 1.7 0.3 1.7 (103 cells/
µL)
GRA 2.3 8.8 2.3 8.8 2.3 8.8 (103 cells/
µL)
RBC 3.26 5.73 2.75 5.59 2.75 5.73 (106 cells/
µL)
HGB 10.1 16.5 8.8 15.5 8.8 16.5 g/dL
HCT 30.6 49.6 26.1 47.4 26.1 49.6 %
MCV 76.4 102.0 76.4 102.0 76.4 102.0 fL
MCH 23.3 36.1 23.3 36.1 23.3 36.1 pg
MCHC 29.7 36.7 29.7 36.7 29.7 36.7 g/dL
RDW 12.2 16.6 12.2 16.6 12.2 16.6 %
3
PLT 97 390 97 390 97 390 (10 cells/
µL)
MPV 7.1 10.9 7.1 10.9 7.1 10.9 fL

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ADVIA 360 Hematology System Specifications

Interfering Substances
The substances below can interfere with parameter measurement and
alternate measurement procedures can be required.

Parameter Interference
WBC > 5 NRBCs/100 WBCs, PLT clumps/large PLTs
RBC WBC Count > 50.0 x 103/µL
MCV WBC Count > 50.0 x 103/µL
PLT PLT clumps/large PLTs (Abnormal histogram)
HGB WBC count > 50.0 x 103/µL, Lipids > 270 mg/dL
Differential > 5 NRBCs/100 WBCs, PLT clumps/large PLTs (Abnormal
histogram)

11170855 Rev. 03 105

Specifications ADVIA 360 Hematology System

106 11170855 Rev. 03

Appendix E: Symbols

This section describes the symbols that can appear on the exterior of the
ADVIA 360 Hematology System or on the system packaging. The symbols
on the system provide you with the location of certain components and
with warnings for proper operation. The symbols on the system packaging
provide you with other important information. For information on the
symbols that appear on the reagent packaging and labeling, see the
related assay instruction for use.

Symbol Description
This symbol is used for both Warnings and Cautions.
• A Warning indicates the risk of personal injury or
loss of life if operating procedures and practices
are not correctly followed.
• A Caution indicates the possibility of loss of data
or damage to or destruction of equipment if
operating procedures and practices are not
strictly observed.
This symbol alerts you to a biohazard.

This symbol alerts you to the risk of exposure to lasers.

This symbol alerts you to a potential electrical hazard.

This symbol alerts you to the risk of corrosive materials

This symbol identifies the location of a protective

earth (GND) conductor terminal.

This symbol indicates that this equipment is classified

as Waste Electrical and Electronic Equipment under
the European WEEE Directive. The equipment must be
recycled or disposed of in accordance with applicable
local requirements.

11170855 Rev. 03 107

Symbols ADVIA 360 Hematology System

Symbol Description
This symbol indicates that the main power supply is
on.

This symbol indicates that the power switch is off.

This symbol indicates that the product has a

temperature limitation. In this example, the product
must be stored at 5° to 25 ° C.

This symbol indicates that you should consult

instructions for use.

This symbol indicates the number used for ordering a

part or product.

This symbol indicates the serial number of a part or

product.

This symbol indicates the revision letter of a part or

product.
This symbol indicates an in vitro diagnostic device or
an in vitro medical device.

This symbol indicates the name and location of the

product manufacturer.

This symbol indicates the date of manufacture of the

product.

This symbol indicates the manufacturer’s authorized

representative within the European community.

This symbol indicates Diluent connection.

108 11170855 Rev. 03

ADVIA 360 Hematology System Symbols

Symbol Description
This symbol indicates a Lyse connection.

This symbol indicates a waste line connection.

This symbol indicates a cleaning line connection.

This symbol indicates the batch code for a product.

This symbol indicates that the product complies with

the applicable directives of the European Union.

This symbol indicates that the product complies with

Canadian Safety Standards (CAN/CSA C22.2 No.
61010-1 2nd edition).

This symbol indicates compliance with the restriction

of hazardous substances used in electrical or
electronic equipment.

This symbol indicates that the input electricity is direct

current.

This symbol indicates a USB port.

This symbol indicates the location of an Ethernet

connection.

This is the UDI symbol that indicates a barcode

containing Unique Device Identifier information.

11170855 Rev. 03 109

Symbols ADVIA 360 Hematology System

110 11170855 Rev. 03

Appendix F: Barcode Reader

Calibrating the Barcode Reader

Use this sheet to calibrate the Motorola DS 4208 bar code reader.
1. Power off the system.
2. Connect the bar code reader to a USB slot on the system.
3. Power on the system.
4. Scan the barcodes in order:
a. Set Factory Defaults
b. <Data> <Suffix 1>
c. Medium Delay.

After scanning completes, the DS 4208 barcode reader is ready to use with
the ADVIA 360 Hematology System.

11170855 Rev. 03 111

Barcode Reader ADVIA 360 Hematology System

112 11170855 Rev. 03

 ADVIA® 560
Hematology System

ADVIA® 560 Hematology System

Operator’s Guide

11316937 Rev. 01, 2020-11

© 2020 Siemens Healthineers. All rights reserved

No part of this manual or the products it describes may be reproduced by any means or in any form
without prior consent in writing from Siemens Healthcare Diagnostics Inc.
ADVIA is a trademark of Siemens Healthineers.

All other trademarks and brands are the property of their respective owners.

The information in this manual was correct at the time of printing. However, Siemens Healthineers
continues to improve products and reserves the right to change specifications, equipment, and
maintenance procedures at any time without notice.

If the ADVIA 560 Hematology System is used in a manner differently than specified by
Siemens Healthineers, the protection provided by the equipment may be impaired. Observe all
warning and hazard statements.

2 / 202 11316937 Rev. 01

Contents

1 Overview
Indications for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Who Should Use This Manual . . . . . . . . . . . . . . . . . . . . . . . . 10
Hardware Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Front Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Back Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Back Panel Tubing Connection Points . . . . . . . . . . . . . . . . . . . . . . 13
Back Panel I/O Ports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Left-Side Assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Right-Side Assembly. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Front Assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Principles of Operation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Volumetric Impedance Method . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Photometric Light Absorbance Method. . . . . . . . . . . . . . . . . . . . . 21
Optical Light Scatter and Diffraction Method . . . . . . . . . . . . . . . . 21

2 Starting Up and Shutting Down

Starting the System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Visual Inspection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Power Up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Start Up the User Interface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
User Logon . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Pneumatic System Start and Blank Measurement. . . . . . . . . . . . . 25
Exiting the System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
Log Off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
Shut Down . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
Prepare for Shipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
Immediate Shut-Down. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
Repackaging the System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

3 System Operation
User Interface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
Using the Touch Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
Using an External Mouse . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
Using an External Keyboard. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34

11316937 Rev. 01 3/202

 Using the On-Screen Virtual Keypads . . . . . . . . . . . . . . . . . . . . . . 34
Using the Graphical User Interface (GUI). . . . . . . . . . . . . . . . . . . . 35
Menu System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
Sample Measurement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
Supported Sample Tubes Types. . . . . . . . . . . . . . . . . . . . . . . . . . . 46
Open or Closed Sample Tubes . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
Sample Identification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .49
Running Samples . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50
Manual Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50
Result screen options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
Automatic Mode of Auto-loader . . . . . . . . . . . . . . . . . . . . . . . . . . 51
Automatic Scanning and Processing . . . . . . . . . . . . . . . . . . . . . . . 53
Full Scan Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
Result Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
The Measurement Process . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
Result Interpretation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62
The Result Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62
Sample Identification Information. . . . . . . . . . . . . . . . . . . . . . . . . 63
Parameter Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64
Scatter Diagrams and Histograms . . . . . . . . . . . . . . . . . . . . . . . . . 66
RBC and PLT Histograms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67

4 Calibration
Calibration Factors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75
Manual Calibration. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 76
Automatic Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 76
Beginning Subsequent Calibrations . . . . . . . . . . . . . . . . . . . 77
Viewing Calibrations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77
Viewing Calibration History . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77
Deleting a Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77
Viewing Calibration Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78
Viewing Calibration Targets. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78

4 /202 11316937 Rev. 01

 5 Quality Control
Setting QC Reference . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 80
Manual Entry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 80
Scanned Entry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 80
QC Measure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81
Viewing QC References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81
Viewing QC Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81
Viewing QC Diagrams (Levey-Jennings) . . . . . . . . . . . . . . . 81
Viewing Moving Averages Data . . . . . . . . . . . . . . . . . . . . . . 82
Viewing Moving Averages Diagrams . . . . . . . . . . . . . . . . . . 82
Testing CAP Survey Material . . . . . . . . . . . . . . . . . . . . . . . . . 83

6 Maintenance
Opening the Front Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . 85
Closing the Front Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 86
Removing the Side Panels . . . . . . . . . . . . . . . . . . . . . . . . . . . 86
User Maintenance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87
Software Maintenance Functions. . . . . . . . . . . . . . . . . . . . . 87
Cleaning the Shear Valve. . . . . . . . . . . . . . . . . . . . . . . . . . . . 90
Cleaning the Wash Head . . . . . . . . . . . . . . . . . . . . . . . . . . . . 93
Software Cleaning Maintenance Functions. . . . . . . . . . . . . 95
Daily Cleaning As Part of Shutdown . . . . . . . . . . . . . . . . . . . . . . . 96
Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 96
Hard Cleaning (Extended Cleaning) . . . . . . . . . . . . . . . . . . . . . . . 97
Reagent Lock and Hardware Key (HK) . . . . . . . . . . . . . . . . . 98
Replenishing the Measurement Count . . . . . . . . . . . . . . . . . . . . . 99

7 Troubleshooting
Instrument Diagnostics . . . . . . . . . . . . . . . . . . . . . . . . . . . . 101
Self Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 101
Log . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 103
Reagent Status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 104
Statistics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 104
Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 105

11316937 Rev. 01 5/202

 Autoloader Diagnostics . . . . . . . . . . . . . . . . . . . . . . . . . . . . 105
Explanation of Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 105
Barcode Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 107
Error Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 107
Pneumatic error messages. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 108
Mechanical Problems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 108
Sample Rotor (SR) Failures. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 108
Measurement results related problems. . . . . . . . . . . . . . . . . . . . 112

8 Data Management
Database Functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 113
Database Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 113
Scrolling the Database View . . . . . . . . . . . . . . . . . . . . . . . . . . . . 114
Sorting Database Information . . . . . . . . . . . . . . . . . . . . . . . . . . . 116
Manual Selection of Database Records . . . . . . . . . . . . . . . . . . . . 116
Automatic Selection of Database Records . . . . . . . . . . . . . . . . . 117
Viewing Detailed Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 117
Statistics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 117
Managing Database Records . . . . . . . . . . . . . . . . . . . . . . . . . . . . 117
Patients . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 121

9 System Configuration
Multi-User Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 123
Types of Users . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 123
Creating a New User . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 124
Deleting or Changing Users . . . . . . . . . . . . . . . . . . . . . . . . . . . . 125
Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 126
Customize Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 126
Laboratory Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 127
External Devices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 127
Laboratory Information System Communication Error . . . . . . . . 128
System Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 129
Units . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 130
Printer Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 131
Profile Limits Settings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 132
Panic Ranges . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 132
Moving Averages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 132

6 /202 11316937 Rev. 01

 Multi-User Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 133
Types of Users . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 133
Date and Time Adjustment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 133

Appendix A: Symbols

Appendix B: Warranty and Support Information

Appendix C: Reagents
ADVIA 360/560 Dil (20L) Information . . . . . . . . . . . . . . . . . 141
ADVIA 560 Lyse 5L Information . . . . . . . . . . . . . . . . . . . . . 142
ADVIA 560 5P Diff 1L Information. . . . . . . . . . . . . . . . . . . . 142
ADVIA 360/560 Hypoclean CC (100 mL) Information . . . . 143
Reagent Warnings and Precautions . . . . . . . . . . . . . . . . . . 144

Appendix D: Reagent Consumption

Appendix E: Error Codes

Error Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 149

Appendix F: Specifications
Environmental Factors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 181
Electrical Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . 182
Space Requirements. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 182
Weight Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 183
Waste Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 183
Known Limitations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 184
Emergency Situations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 184
Performance Characteristics . . . . . . . . . . . . . . . . . . . . . . . . 185
Precision . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 185
Accuracy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 186
Normal Mode Linearity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 186
Carry-over and Reportable Ranges. . . . . . . . . . . . . . . . . . . . . . . . 186
Sample Stability . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 187
Reference Ranges. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 188
Analytical Measurement Range . . . . . . . . . . . . . . . . . . . . . 190
Interfering Substances. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 191

11316937 Rev. 01 7/202

 Appendix G: Parameter Calculations
Calculation Formulas . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 193
Parameter Display Ranges . . . . . . . . . . . . . . . . . . . . . . . . . . 196

Appendix H: Installation
ADVIA 560 Hematology System Package Contents . . . . . 197
Autoloader Package Contents . . . . . . . . . . . . . . . . . . . . . . . 197

Appendix I: Barcodes

Appendix J: AutoSampler Error Codes

11316937 Rev. 01 8/202

1 Overview

The ADVIA® 560 Hematology System is a fully-automated, high-quality

hematology system for in vitro diagnostic use in clinical laboratories.
• The system uses the impedance method for measurement of leukocyte
(WBC), erythrocyte (RBC), and platelet (PLT).
• Hemoglobin (HGB) concentration of red blood cells is measured by
photometrics.
• The system provides a 5-part WBC (LYM%, MON%, NEU%, EOS%, BAS%)
differential measurement using a laser-based optical flow-cytometry
technology.

The ADVIA 560 Hematology System identifies patients with hematologic

parameters within and outside of established reference (normal) ranges.

CAUTION
If equipment operation is different from the manufacturer’s specifications
and intended use, the protection provided by the equipment can be
impaired.
Misuse of equipment or use for other than its intended purpose
invalidates conditions of warranty. Accuracy and precision can also be
impaired.

• The ADVIA 560 Hematology System supports printers via USB ports.
• The internal database can store 100,000 patient, Quality control (QC)
and calibration results including flags, graphical scatter diagrams, and
histograms.
• The system software is field-upgradeable via a USB storage device to
ensure up-to-date operation.
• An automatic optional Auto-loader (sold separately) is available for
automated processing of up to 100 sample tubes for increased
laboratory efficiency and automation.
• In addition to standard serial interfaces, the system uses advanced
Ethernet connectivity with HL7 protocol.

11316937 Rev. 01 9 / 202

Overview ADVIA 560 Hematology System

Indications for Use

The ADVIA 560 Hematology System is a quantitative multi-parameter
automated hematology analyzer designed for in-vitro diagnostic use in
clinical laboratories for enumeration of the following parameters in K2 and
K3 EDTA anti-coagulated venous whole blood samples:
WBC, LYM%, LYM#, MON%, MON#, NEU%, NEU#, EOS%, EOS#, BAS%,
BAS#, RBC, HGB, HCT, MCV, MCH, MCHC, RDWcv, RDWsd, PLT, MPV, PCT,
PDWsd, PDWcv, PLCC, and PLCR.
The ADVIA 560 Hematology System is indicated for use to identify patients
with hematologic parameters within and outside of established reference
ranges.

Who Should Use This Manual

This user manual is intended for clinical laboratory professionals using the
ADVIA 560 Hematology System. The manual includes information about
the operation and user interface of the ADVIA 560 Hematology System.
This manual also contains basic steps necessary to perform the setup
procedures to customize the operation of the analyzer to the requirements
of your laboratory.
This manual also describes daily routine maintenance requirements to
keep your analyzer functioning properly.

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ADVIA 560 Hematology System Overview

Hardware Overview
Front Panel
The front panel is a hinged cover that provides access to the shear valve
and syringes for cleaning and maintenance.

Figure 1: ADVIA 560 Hematology System Front Panel

1 Touchscreen
2 Status light
3 Sample Rotor Station and sample tube adapter

• Clean the front panel, touchscreen, and sample rotor with a lint-free
tissue damp with distilled water.
• Status light color indicates the mode of the
ADVIA 560 Hematology System:
○ Green – ready mode
○ Red – busy mode
○ Orange – standby mode

11316937 Rev. 01 11 / 202

Overview ADVIA 560 Hematology System

Back Panel
Figure 2: ADVIA 560 Hematology System Back Panel

1 Power Connector
2 Power On/Off Switch
3 I/O Ports Panel
4 System Computer On/Off Switch
5 Label displaying the power rating, serial
number, and other manufacturing information
6 Tubing connection points

The power supply switch (2), located above the power supply
connector (1), turns on and off the built-in power for the system. Leaving
the power supply on enables the ADVIA 560 Hematology system to remain
in standby state (status light is orange).
The power on/off switch (4) is spring-loaded and returns to its original
position when released.

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ADVIA 560 Hematology System Overview

Five color-coded tubing connectors provide connection to the reagents.

There are three reagent connectors and two separate waste connectors.
• Green – ADVIA® 360/560 Dil diluent
• Orange – ADVIA 560 5P Diff
• Yellow – ADVIA 560 Lyse
• Red – 2 waste connections

Back Panel Tubing Connection Points

Figure 3: Liquid Connectors

1 Diluent: ADVIA 360/560 Dil

2 ADVIA 560 5P Diff
3 Waste out
4 ADVIA 560 Lyse

11316937 Rev. 01 13 / 202

Overview ADVIA 560 Hematology System

Back Panel I/O Ports

The I/O port connectors provide standard connection to peripherals such as
external keyboard, mouse, printers, and barcode readers.

Figure 4: Hardware Block 2

1 PS2 Mouse port for optional mouse

2 PS2 Keyboard for optional PS2 keyboard
3 COM port for LIS
4 DVI-D port (unused)
5 Two Ethernet ports for LIS
6 Line-in jack (unused)
7 Audio-out jack (unused)
8 Audio-in jack (unused)
9 Four USB 2.0 ports for peripherals
10 VGA port (unused)
11 COM port for LIS

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ADVIA 560 Hematology System Overview

Figure 5: Hardware Block 3

1 COM port 1
2 COM port 2
3 LAN 1
4 LAN 2
5 Mouse port
6 Audio-out jack (unused)
7 Audio-in jack (unused)
8 Keyboard
9 Display port
10 DVI
11 DC-In

11316937 Rev. 01 15 / 202

Overview ADVIA 560 Hematology System

Left-Side Assembly
To access the left-side assembly, the side panel must be removed. See
Chapter 6, Maintenance in the Removing the Side Panels section for more
information.

Figure 6: Left-side Assembly

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ADVIA 560 Hematology System Overview

1 Pressure Sensors The Pressure sensors measure the differential

pressures of the vacuum buffer for impedance base
measurement and optical measurement.
2 Drain Buffer The Drain buffer controls chamber draining.
3 Mix Chamber The Mix chamber performs the first step of RBC
dilution.
4 RBC Chamber The RBC chamber performs the second step of RBC
dilution and contains the RBC aperture.
5 WBC Chamber The WBC chamber performs the WBC dilution and
holds the WBC aperture and HGB photometric
measurement head.
6 Valves 1–22 Valves 1–22 are connected pneumatic components
to perform dilution, reaction, measurement, and
waste disposal processes.
7 Valves 23–44 Valves 23–44 are connected pneumatic components
to perform dilution, reaction, measurement, and
waste disposal processes.
8 Diluent buffer The Diluent buffers are reservoirs for ADVIA 360/560
Dil 20L diluent.
9 Diff and Lyse buffers The Diff-5P buffer is a reservoir for ADVIA 560 5P Diff
1Lreagent.
The Lyse-5P buffer is a reservoir for ADVIA 560 Lyse
5Lreagent.
10 Sheath buffer The Sheath buffer is a reservoir for ADVIA 360/560Dil
20L diluent for optical measurements.
11 Small measure buffer The Small Measure buffer is a vacuum buffer used
for impedance measurement.

11316937 Rev. 01 17 / 202

Overview ADVIA 560 Hematology System

Right-Side Assembly
To access the right-side assembly, the side panel must be removed. See
Chapter 6, Maintenance in the Removing the Side Panels section for more
information.

Figure 7: Right-side Assembly

1 Wash Head The Wash head cleans the aspiration needle to

prepare for the next sample.
2 Horizontal, Vertical The Horizontal, vertical motion (X-Y) unit positions
motion (XY) unit the aspiration needle.
3 Aspiration Needle The Aspiration / piercing needle aspirates a blood
sample from an open or closed sample tube.
4 Optical Head The Optical head contains the laser source, optical
detectors and the flowcell for optical measurement.
5 Power Supply The Power supply provides the system with electrical
power.
6 Auto-loader The Auto-loader connector powers and controls the
connector optional Auto-loader.

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ADVIA 560 Hematology System Overview

Front Assembly
Remove the front panel to access the front assembly. See Chapter 6,
Maintenance for information on opening the front panel.

Figure 8: Assembly Behind the Front Panel

1 Dilutors The Dilutors control the volume and flow rate of reagents
through the pneumatic components.
2 Shear valve The Shear valve is an integrated multi-functional valve for
segmenting precise volumes of blood.
3 Optical Head Unit The Optical head contains the laser source, optical
detectors and the flowcell for optical measurement.
4 Sample rotor The Sample rotor holds the sample tube in a adapter and
rotates the sample tube inside for aspiration.

11316937 Rev. 01 19 / 202

Overview ADVIA 560 Hematology System

Principles of Operation
The ADVIA 560 Hematology System uses a combination of methods to
provide measurement results:
• Volumetric impedance is used to determine the quantity and volume
distributions of leukocytes (WBC), erythrocytes (RBC), and
platelets (PLT).
• Photometric measurement of light absorbance is used to determine
hemoglobin (HGB) concentration.
• Optical measurement of light scattering and diffraction is used to
determine five part leukocyte (LYM%, MON%, NEU%, EOS%, BAS%)
differential parameters.

Volumetric Impedance Method

The volumetric impedance method determines quantity and volume
distributions of cells by detecting and measuring changes in electrical
impedance when particles suspended in a conductive liquid pass through a
small aperture. The method is volumetric because a small known volume
of blood is precisely diluted with a conductive diluent and vacuum pulled
through the aperture at a fixed rate.
A constant direct current flows between the electrodes on either side of
the aperture. Each cell passing through the aperture causes a change in the
electrical impedance of the conductive blood cell suspension. This change
is sensed by the ADVIA 560 Hematology System electronics and converted
to an electrical pulse. The quantity of pulses is proportional to the number
of particles. The intensity of each pulse is proportional to the volume of the
particle. The volume distribution diagrams of the particles result in the
WBC, RBC, and PLT histograms that measured in femtoliter volume units.
Electronic discrimination allows separation of erythrocytes (RBC) and
platelets (PLT). A lytic reaction lyses erythrocytes to clearly measure
leukocytes (WBC).

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ADVIA 560 Hematology System Overview

Photometric Light Absorbance Method

A lysed blood sample dilution can be analyzed for hemoglobin (HGB)
concentration based on its stable chromogen content.
The reagent lyses the red blood cells causing the release of cellular
hemoglobin. The hemoglobin concentration is measured by taking a
photometric reading across the ADVIA 560 Hematology System WBC
chamber. The HGB measurement is calculated as the difference between
and blank and a sample measurement with and without illumination to
reduce the effect of liquid refraction and incident light.

Optical Light Scatter and Diffraction Method

Optical measurement of light scattering and diffraction is used to
determine five part leukocyte (LYM%, MON%, NEU%, EOS%, BAS%)
differential parameters. An optical measuring head contains a focused
laser source that is used to illuminate a stream of leukocytes (WBC)
suspended in an optically clear diluent moving through a flow cell.
The cells scatter light as they flow through the path of the laser beam. An
optical detector senses changes in the intensity of the scattered laser light
which are proportional to the cell volume and granularity of the cell’s
internal structure. The ADVIA 560 Hematology System electronics convert
these changes to electrical pulses which are gathered and stored for
analysis. Five part population discrimination is based on analysis of the two
dimensional volume and granularity distribution scatter diagram.
Cells with greater volume or size or more granularity will tend to scatter
greater amounts of light. The intensity of scattered light is detected by an
optical signal processing system.

11316937 Rev. 01 21 / 202

Overview ADVIA 560 Hematology System

External structure and the size of the cell cause lower angles of scatter, and
internal granularity or complexity causes higher angles of diffraction. Both
low and high angles of light scatter are captured by optical sensors,
providing the ADVIA 560 Hematology System with two independent
measurements for each cell crossing the path of the laser beam.

Figure 9: Light Scatter Diagram

1 Laser light source

2 High angle scattered light
3 Low angle scattered light
4 Direct light
5 Low angle scattered light
6 High angle scattered light

22 / 202 11316937 Rev. 01

2 Starting Up and Shutting Down

The ADVIA 560 Hematology System is an advanced instrument with

computer and pneumatic subsystems that need to be properly started up
and shut down for continuing reliable performance. Not following proper
startup and shutdown procedures may lead to increased maintenance and
unnecessary service calls.
The ADVIA 560 Hematology System start up sequence requires four steps:
1. Power up the electrical system.
2. Start up the internal user interface computer and log in if the multi-
user mode is activated.
3. Start up the pneumatic system components.
4. Perform and accept an initial blank measurement.
A normal shut down of the ADVIA 560 Hematology System has the reverse
steps:
1. Clean and empty the pneumatic system components.
2. Log off (multi-user mode is activated) and properly shut down the
internal user interface computer.
3. Power down the electrical subsystem.
The ADVIA 560 Hematology System also has a prepare for shipment shut
down option that performs an extended cleaning and emptying of the
pneumatic components. This option can be used to prepare the
ADVIA 560 Hematology System for an extended period of inactivity or for
shipping to a new location.
There are also emergency shutdown procedures in case of emergency.

Starting the System

Visual Inspection
Perform a visual inspection of the ADVIA 560 Hematology System before
starting up. This is particularly important if the
ADVIA 560 Hematology System is operated by multiple operators.
• Check the reagent tubes by gently pulling on the tubes to ensure that
connections are not loose.
• Open the front cover and ensure that there is no leakage around the
shear valve or the syringe pumps.

11316937 Rev. 01 23 / 202

Starting Up and Shutting Down ADVIA 560 Hematology System

• Check for salt stains around the reagent tubing and the reagent
containers.
• Check that the power cord is plugged in both into the back panel of the
ADVIA 560 Hematology System and to the wall outlet.
• Empty the waste container. After start up reset the waste level in the
Main menu/ Diagnostics/Reagent status panel.

Power Up
1. Turn on the main power switch (small switch) on the rear panel of the
system located near the power connection to the up position labeled
1 to power on the electrical system of the
ADVIA 560 Hematology System analyzer.
2. If the optional Autoloader is installed, turn the power switch on the
right side of the Autoloader to the on position labeled 1 to power on
the electrical system of the Autoloader.
3. Turn on printers or any peripherals that have power switches.
The electrical system of the ADVIA 560 Hematology System can remain
powered up indefinitely. Follow local regulations or laboratory procedures
when deciding whether to fully power down the
ADVIA 560 Hematology System after work hours.

Start Up the User Interface

To start up the internal user interface computer of the
ADVIA 560 Hematology System, move the power on switch near the top of
the rear panel of the ADVIA 560 Hematology System to the up position.
The standby switch springs back to the down position after activation.
The following sequence of events takes place after enabling the standby
switch:
1. The internal computer starts up.
2. The Windows operating system starts up.
As the display initializes the screen changes color.
3. The ADVIA 560 Hematology System application software starts up
displaying the ADVIA 560 Hematology System logo screen. Individual
component start up status is displayed in the bottom right corner of the
logo.

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ADVIA 560 Hematology System Starting Up and Shutting Down

4. If the multi-user option is enabled then a user ID and password is

required.
5. The ADVIA 560 Hematology System main menu is displayed.
At this point, the ADVIA 560 Hematology System user interface is ready to
use, but the analyzer is not yet ready to measure samples. This requires
initialization of the ADVIA 560 Hematology System pneumatic system. The
following functions are available at this time:
• Use the patient database to add and modify entries.
• Review, archive, send to LIS and print existing measurement records.
• Review calibration and QC results and history.
• Change settings.

User Logon
If the multi-user feature is activated, a user must be logged in before the
user interface of the ADVIA 560 Hematology System can be accessed. You
can log in two different ways:
• Enter the user ID and password assigned to your account.
• Create a new user account.
The multi-user feature of the ADVIA 560 Hematology System tracks which
user is logged on when important activities are performed such as sample
or QC measurements or calibration. The multi-user feature allows full
access to administrator users while restricting regular users from actions
that change the way the ADVIA 560 Hematology System operates, such as
changing calibration settings.
See Chapter 9, System Configuration for details about user management.

Pneumatic System Start and Blank Measurement

Before measuring any blood or control samples, the pneumatic system
components of the ADVIA 560 Hematology System need to be initialized
and a blank measurement run and accepted. To start the pneumatic
system and run a blank measurement, click or tap the Measure icon with
the single test tube graphic on the top left corner of the screen. The
following sequence takes place:
• The color of the Status button changes to red.
• The reagents are primed.
• The measuring system is flushed.
• The sample-door, syringe, needle x/y movement, and shear valve
motors are activated and tested.

11316937 Rev. 01 25 / 202

Starting Up and Shutting Down ADVIA 560 Hematology System

• The vacuum system is activated, and pump sensors and vacuum

leakage is tested.
• An empty result screen is displayed.
• Blank measurement should be performed by user.
The results of a blank measurement must be accepted before blood or
control samples can be processed.
NOTE: The analyzer can run the first Blank measurement three times
automatically if the results are not within range. The system will give the
start measurement sound to warn the user that the Blank is repeated. After
the third measurement, the results are displayed.
If the results from the first blank measurement are not acceptable,
consider the following:
• Blood proteins or other particles can accumulate in the pneumatic
tubing or components.
• Contaminated reagent may cause high background. Perform cleaning/
hard cleaning, replace the diluent and try Blank measurement again.
• An extended period of inactivity without performing a ‘prepare for
shipment’ procedure may result in salt crystal development in the
pneumatic components, which will increase background count.
Perform cleaning.
Running additional blank measurements will usually bring the blank
measurements down to an acceptable level. Blank measurements will be
flagged if they exceed the following thresholds:
• WBC >0.20 x 103 cells/μL
• RBC >0.05 x 106 cells/μL
• PLT >15 x 103 cells/μL
• HGB >1.0 g/dL
If the ADVIA 560 Hematology System was not in use for an extended
period of time, the startup of the pneumatic system components can take
significantly longer and require more blank measurements. To prevent
these problems, use the ‘prepare for shipment’ process when the
ADVIA 560 Hematology System will be inactive for an extended time.

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ADVIA 560 Hematology System Starting Up and Shutting Down

Exiting the System

After you have completed lab operations and you are ready to exit the
ADVIA 560 Hematology System, you can:
1. Log off
2. Shut down ADVIA 560 Hematology System
3. Power off ADVIA 560 Hematology System
4. Prepare ADVIA 560 Hematology System for shipment
Click or tap the Exit icon on the main menu to access various exit options.
Click or tap the Cancel button to return to normal operation.

Log Off
Clicking or tapping the Exit icon on the main menu brings up the Shutting
down Analyzer panel. Select Log off to end the active user session.
After the current user is logged off the logon panel is displayed.

Shut Down
The shutdown procedure must be used to maintain the reliable operation
of the instrument. To properly shut down the
ADVIA 560 Hematology System, click or tap the Exit icon on the main
menu and select Shutdown.
The shutdown procedure performs two key functions:
• If the pneumatic system components of the
ADVIA 560 Hematology System were initialized, a shutdown procedure
is performed that rinses the pneumatic components. This prepares the
instrument for a period of inactivity of up to 5 days.
• The ADVIA 560 Hematology System operating software and the
Windows operating system are shut down. The analyzer saves all
settings, closes the file system and database, and automatically shuts
down the internal user interface computer.
The ADVIA 560 Hematology System can ask to perform cleaning based on
the analyzer usage patterns and the state of the pneumatic components. If
this occurs, the ADVIA 560 Hematology System will request that a tube
with cleaning reagent be introduced at the sample rotor. The cleaning
procedure may take a few minutes. Do not turn off the analyzer until the
system indicates that it is safe to do so.

11316937 Rev. 01 27 / 202

Starting Up and Shutting Down ADVIA 560 Hematology System

CAUTION
If the ADVIA 560 Hematology System is powered off without proper
shutdown or prepare for shipment procedure, the following occur:
• The pneumatic components lock in an undefined state. The next
startup and pneumatic initialization may take longer with increased
reagent consumption.
• The ADVIA 560 Hematology System software and the operating
system can suffer damage or data loss.
• The ADVIA 560 Hematology System has to be restarted by a service
engineer after an improper shutdown or power off sequence.

Prepare for Shipment

If the ADVIA 560 Hematology System is not to be used for more than
5 days or is being transported to a new location then perform the Prepare
for shipment procedure instead of the regular shutdown procedure.
1. Select Exit on the main menu.
2. Select Prepare for shipment.
The Prepare for Shipment procedure should be used for following reasons:
• The reagents may spill out if the ADVIA 560 Hematology System is
tilted, potentially causing electrical short circuit or corrosion.
• Reagents can flow out of the ADVIA 560 Hematology System if the
reagent intakes are disconnected.
• Evaporation may cause reagents left in the pneumatic components in
the ADVIA 560 Hematology System analyzer to become concentrated
and form crystals that increase blank results, damage pneumatic
components, and may require a service engineer to restore proper
operation.
• Microbial growth may occur if reagents are left in an inactive analyzer
for extended time periods, causing high blank results and may require
a service engineer to restore proper operation.
• Accidental storage at very low temperatures may cause freezing that
damages the pneumatic components.
The Prepare for shipment procedure should be used if the analyzer will be
inactive for more than five days. Higher temperature or lower humidity
decreases the period of time the ADVIA 560 Hematology System can be
idle without performing the Prepare for shipment procedure.
The analyzer will guide you through the preparing for shipment process.

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ADVIA 560 Hematology System Starting Up and Shutting Down

This process takes about 30 minutes and requires the following items:
• Prepare for shipment tube set included with your
ADVIA 560 Hematology System
• Distilled water
After initiating the Prepare for shipment procedure the system prepare for
the draining process. Do not power off the analyzer during these steps
unless the system indicates that is safe to do so.
1. The analyzer prompts you to disconnect the reagents from the reagent
connectors on the back panel except for the waste connection.
2. Leave the waste container tubing connected to the analyzer.
The system drains all inner reagent buffers throughout the pneumatic
system.
This step takes approximately 9 minutes. Do not turn the analyzer off
during this step.
3. The instrument prompts you to connect distilled water to the reagent
inputs.
Use the Prepare for shipment tube set that was included with your
ADVIA 560 Reagent Tubing Set.
The system primes and fully rinses the tubing and pneumatic system
with distilled water. This step takes approximately 7 minutes. Do not
turn the analyzer off during this step.
4. The analyzer prompts you to disconnect the prepare for shipment tube
set from the reagent connectors on the back panel except for the waste
connections.
Leave the waste container tubing connected to the analyzer. The
analyzer drains all liquids from the instrument.
This step takes approximately 10 minutes. Do not turn the analyzer off
during this step.
When the process is over, the system indicates the instrument should be
powered off. Tap the OK button on the notification panel and wait until
Windows exits and power off the user interface computer.

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CAUTION
Do not turn off power of the ADVIA 560 Hematology System at this
stage. First tap the OK button, then wait until Windows operating system
exits and shuts down the internal ADVIA 560 Hematology System user
interface computer.
After the shutdown process completes, press the main power switch on
the rear panel to the off position.

Disconnect the waste container tubing from the waste connector on the
back panel of the ADVIA 560 Hematology System.
Small droplets of distilled water may remain in the tubing after the Prepare
for shipment process completes. These droplets will not cause any
malfunction during transportation or the next start up procedure.
Emergency Shut Down
CAUTION
The procedures described in this section can damage the
ADVIA 560 Hematology System or cause data loss or damage to critical
system computer files. Use these procedures in case of emergency only!

Immediate Shut-Down
The immediate shut-down can be initiated by pressing the power on
button near the top of the back panel of the
ADVIA 560 Hematology System. This is the same button which is used to
start up the ADVIA 560 Hematology System user interface computer. This
shuts down the user interface computer without properly shutting down
the pneumatic system components.
Possible side-effects:
• The pneumatic components may be left in an undefined state. The next
startup and pneumatic initialization may take longer with increased
reagent consumption.
• The last settings changes and measurement results are not saved.
Immediate shut down should be avoided as a routine procedure.
Immediate shut down should only be used if loss of electrical power is
imminent such as thunderstorms or if loss of uninterruptible power supply
(UPS) backup power is imminent.

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Immediate Switch Off

In case of immediate danger, power off the
ADVIA 560 Hematology System by performing the following actions:
• Turn off the main laboratory power supply,
• Unplug the power cord from the wall outlet,
• Turn off the main power switch (small switch) on the rear panel of the
ADVIA 560 Hematology System located near the power connection to
the ‘down’ position labeled 0.

Repackaging the System

Before repackaging your ADVIA 560 Hematology System for transportation
or storage, always perform the following actions:
• Perform a Prepare for shipment procedure.
• Fully power down the analyzer.
• Make sure to disconnect all reagent tubes, power cords and peripheral
connections.
• Clean the shear valve and put pull out card between the two ceramics
plates.
• Always use the original packaging materials to repackage the
ADVIA 560 Hematology System.
Prepare the following packaging materials that were included in your
original shipment:
• Mini-pallet
• Upper and lower packaging foams
• Upper and lower carton box
• Accessory box for power cord, reagent tubing, sample adapter, etc.
• Plastic bag with desiccant bag

Packing the system

1. Collect all accessories into the accessory box.
2. Place the pallet on the ground.
3. Place the lower part of the carton box on the pallet.
4. Place the lower packaging foam on the carton bottom.
5. Place the ADVIA 560 Hematology System into the plastic bag, and
place the system into the bottom foam part.
6. Put a desiccant bag into the plastic bag, and close the bag.

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7. Place the top packaging foam on the analyzer.

8. Place the accessory box on top of the top foam spacer.
9. Put on the top carton cover box over the package.
10. Align the lower carton box flaps so that the flaps fit beneath the upper
box edges.
Use shipping straps to fix and hold the package on the pallet.

CAUTION
Use shipping straps or band to hold the package fixed on the pallet,
otherwise the analyzer can be seriously damaged during shipping.
Do not apply excess force to the straps because excess force can break
the carton box and damage the analyzer.
Never place the analyzer upside down on the pallet!

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3 System Operation

User Interface
The user interface of the ADVIA 560 Hematology System analyzer is
designed to be intuitive and easy to use, and provide access to all user level
functions. You can interact with the ADVIA 560 Hematology System by
using only the touch screen and the virtual on-screen keypad, or by using
an external keyboard and mouse (PS2 or USB).

Using the Touch Screen

CAUTION
Simple operations are supported, but multi-touch gestures or multiple
tapping are not supported and can result in system lockup.

The touchable items on the ADVIA 560 Hematology System user interface
are designed to be large enough to tap with a finger. The use of a tapping
tool may be useful if the operator has larger or thicker fingers, or when
wearing oversize gloves. A tapping tool can be pencil eraser or a specially
designed stylus available at computer or consumer electronics stores.
Do not use sharp or heavy objects to operate the touch screen. The surface
material is moderately resistant to liquids. Avoid touching the screen with
wet fingers, or allow liquids to come in contact with the screen or the
surrounding area.
If you find that the ADVIA 560 Hematology System touch screen responds
in a different area, rather than the area you are tapping, then perform a
touch screen calibration procedure before calling for service or support.

Using an External Mouse

An external mouse can be used to perform the same functions as the touch
screen. Navigate the mouse pointer over the desired item and select the
left mouse button instead of tapping the touch-screen to activate the
function. This procedure is referenced as selecting (select) an item. Touch
screen operation continues to be available even if an external mouse is
connected to the ADVIA 560 Hematology System.
The mouse pointer can move to a place on the screen where the mouse
pointer is not viewable. Move the mouse pointer up or to the left to make
the pointer visible again.

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Using an External Keyboard

An external keyboard provides the same data entry features as the
on-screen virtual keypad presented by the touch screen user interface with
faster typing.
The Settings/Customize/On screen keyboard active check-box enables
you to choose whether the on-screen virtual keypad is presented or not
when data entry is required (name, sample ID, target value). If the check
box is left unchecked, then the on-screen virtual keypads are not presented
and an external keyboard is required for data entry. If the check box
remains checked, the external keyboard can still be used by pressing the
ESC key on the external keyboard to dismiss the on-screen virtual keyboard
and complete the data entry using the external keyboard.

Using the On-Screen Virtual Keypads

There are three types of virtual on-screen keypads:
• Alpha-numeric with shift and symbol options
• Numeric only
• Date
The particular virtual on-screen keypad presented is tailored to the data
entry required. If only numeric values are accepted than a numeric-only
keypad is presented. For selection of dates, a date keypad is presented.
The touch-pad of the ADVIA 560 Hematology System handles single taps
only. The Shift and Symbol keys are sticky on the virtual on-screen keypads
like the caps-lock on a PC key-board. Select or tap on the appropriate
buttons to type in the required value. Complete the operation by selecting
or tapping the Done button. The Symbols button presents special
characters such as the question mark or ampersand.

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Using the Graphical User Interface (GUI)

The graphical user interface (GUI) of the ADVIA 560 Hematology System is
divided into 3 main sections.
The main menu in Figure 10 displays in the interactive display area when
the ADVIA 560 Hematology System is initially powered up.

Figure 10: Home Screen

1 Quick links to main functions

2 Interactive display
3 Status display

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System Operation ADVIA 560 Hematology System

Quick Links
The top of the GUI is always visible during all operations and presents
several quick link buttons. Selecting one of the quick link buttons
determines what is displayed in the interactive display area. The selected
button is highlighted.
The quick link for Autoloader functions is enabled only if the optional
Autoloader is connected and turned on.

Interactive Display
The middle section of GUI is used to display the main menu, functions,
information, results, etc.

Status Display
The bottom section of GUI is the Status display, and presents the user with
the following:

Figure 11: Status Display

AS state Status of the Auto-loader unit. If not lit, the Auto-

loader is not connected, or turned off

The state of the reagent and waste containers

Green: Diluent
Yellow: Lyse
Orange: Diff
Red: Waste

Error and Tap the icon for detailed information

Warnings Icon

Printer status In-progress or in Standby

Pneumatic Standby, manual measure, rinse, clean, and so forth

system status

Language and Selected language and keyboard layout language

Keyboard

Current time Tap to show date and time setting window

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Entering Information
Enter information using the on-screen keypad or an external keyboard and
mouse. To activate a data field, tap (or click) its field.
• An enabled data entry field is white.
• A field changes to yellow when tapped, indicating that the field is
active and can accept data.
• If a data entry field is disabled or unavailable, the field appears darker
or shaded.
Data is not saved until the operator taps Enter, OK, Save, or Accept,
depending on the screen. Tap Cancel to discard changes and return to
previous screen.

Menu System
The graphical user interface of the ADVIA 560 Hematology System has
primary functions that are accessible directly by means of icons or controls
that are always available to the operator.
The ADVIA 560 Hematology System also has secondary functions that are
available via two or more taps or selects through the menu structure, or
menu tree.

Primary Menu Items

The following menu items or functions are directly accessible:
• Start a manual single tube measurement
• Start an automated measurement
• Access the database
• Initiate printing
• Access the main menu
• Access the control panel of the Autoloader (opens with double select or
tap)
• Access the time adjustment panel (opens with double select/tap)
• Access the warnings panel (only visible if an error or warning was
reported)

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System Operation ADVIA 560 Hematology System

Starting a Manual Single Tube Measurement

Tapping or selecting on the Measure icon with the single sample tube
graphic allows access to the following functions:
• Initiate a primary blank measurement
• Make adjustments and settings about the manual measurement
• Enter the Sample ID (unique or auto-increment)
• Select the associated patient
• Select the sample type or patient mode
• Start a manual measurement
• View the measurements results in detail:
• View the measured parameters
• View the calculated parameters
• View parameters that are out of the normal range
• View error, warning, or clinical flags
See section Manual Mode for more information.

Start Automated Measurements

Tapping or selecting the AS icon with the multiple sample tube graphic
allows access to the following functions:
• Initiate automated measurements in one of four modes:
○ Full scan mode
○ Free list mode
○ Selected samples mode
○ Remote worklist mode
• Define sample parameters (the parameter list depends which one of
the three sample modes are selected)
• Monitor the progress of the automated measurements
• View the details of completed measurements

Access the Database

Tapping or selecting the Database icon with the file cabinet with wrench
graphic allows access to the following functions:
• Select completed measurements that are stored as database records.
• Export database records for storage or import results for viewing
• Delete database records

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ADVIA 560 Hematology System System Operation

• Send database records to the LIS

• Review the details of selected measurements
See Chapter 8, Data Management for more information about accessing
and using the ADVIA 560 Hematology System database.

Initiate Printing
Tapping or selecting the Print icon with the printer graphic will print the
active panel or measurement result according to the printer settings.
See Chapter 9, System Configuration for more information about printing
on the ADVIA 560 Hematology System.

Main Menu
Tapping or selecting the Menu icon with the main menu graphic displays
and allows access to the main menu. The main menu is automatically
displayed when the ADVIA 560 Hematology System is started up. The main
menu icons are arranged in an intuitive circular design.

Autoloader (AS) Control Panel

If you have an optional Autoloader installed, the AS control panel can be
opened by double selecting/tapping the AS state on the left side of the
status display on the bottom of the screen.
The AS control panel allows you to see if the Autoloader is operational and
perform an Autoloader initialization.

Adjust the Time and Date

Double select or tap the time display on the right side of the status display
to adjust the stored time and date of the ADVIA 560 Hematology System.
See Chapter 9, System Configuration for more information about time and
date adjustment.

Open the Warning Panel

If an error or warning is currently active, an exclamation point icon appears
on the status display. Select the icon to review the active error or warning
and jump to the appropriate menu where the error or warning can be
addressed (such as reagent replacement).

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System Operation ADVIA 560 Hematology System

Menu Tree
The following table lists the ADVIA 560 Hematology System main menu
tree:

Menu Description

Patient

New Add a new patient

Edit Modify an individual patient’s information

Details View an individual patient’s information

Exit

Cancel Cancels shutdown of the

ADVIA 560 Hematology System

Prepare for shipment Performs an extensive drain procedure of the

ADVIA 560 Hematology System pneumatic
system in preparation for shipment or an
extended period of inactivity

Log off Logs off the current user session

Shutdown Prepares the ADVIA 560 Hematology system

for a complete shutdown

Settings > Customize

Patient’s displayed Patient identifier visible in the database

data display

Language Change the active language

Limit Style View parameter normal range status in

numerical or graphical format

Sound Volume Change the volume of the built-in speaker

On screen keyboard Turn off on-screen virtual keypads for use with
active an optional external keyboard

Laboratory Lines of text with lab information that appears

on each printed page

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Menu Description

Settings > External Devices

Sending port baud Select transmission rate for serial LIS

rate

Automatic LIS Select whether to automatically transmit

results each time a sample is processed

LIS Select Ethernet LIS connection

IP IP address of Ethernet-based LIS host

computer

Port Port number of Ethernet-based LIS host

computer IP address

Bidirectional LIS Selects whether Autoloader can receive

remote worklists from the host computer

Settings > System

Special flags (G, L) Select the check box to display the G, L flags

Waste container Selects a 10L, 20L, or no waste container

volume (direct to drain)

Database display limit Selects all or only last month of database

record display

Use only Sarstedt- Change sampling adjustments to

Monovette tube from accommodate Sarstedt Monovette tubes
sample rotor

Standby time Time period of inactivity before the

ADVIA 560 Hematology System automatically
enters standby

Offline rinsing Time period of inactivity before the

frequency ADVIA 560 Hematology System performs an
offline rinse to keep the pneumatic system in
peak operating condition

Screen saver Time period of inactivity before screen saver

takes effect

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System Operation ADVIA 560 Hematology System

Menu Description

Blank request time Time interval between system requests to

process a blank specimen (0 h = no blank
request reminders)

Settings > Units

HGB unit Selects the units for HGB and HGB-derived or

calculated parameters

Count unit Selects the units for WBC, RBC, and PLT and
derived or calculated parameters

Settings > Printer

Printer Selects which printer to print to

Printer status Display the currently selected printer status

Color printing Selects whether to print in color

Double sided printing Selects whether to print multi-page printouts

on both sides of a page

Items in queue Number of items in the printer queue

Cancel all jobs Cancels all items in the selected printer’s

queue

Pre-printed paper’s Reserves space (pixels) at top of page for pre-

header length (px) printed letterhead

Automatic print Selects whether to print for every new sample

processed

Logo visible Select to display company logo on screens and

printed reports

Refresh printers list Refreshes the list of displayed printers

Settings > Profile limits

Profile limits Enter normal ranges for Human, Male,

Female, and Alternate 1 and 2 profile limits

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Menu Description

Settings > Moving averages

Moving averages Set ranges, targets, and action % for the

moving average parameters: MCV, MCH and
MCHC

Settings > User

User Add and manage users of the ADVIA 560

Hematology System (only available to
administrator users)

Delete user Initiates deletion of a user account

Administrator Selects or deselects administrator privileges

for the currently selected user

Maintenance

Cleaning Perform extended cleaning of various

pneumatic components

Draining Drain various internal system reservoirs

Empty chamber Empty RBC, WBC, and mix chambers

Prime Prime one or all reagent reservoirs

Fill Fills the fluidic components of the system

with reagents

Show MS On-Screen Displays a vertical keyboard

Keyboard

Touchscreen Calibrate the touchscreen location for taps

and button presses

Reset Autoloader Sets Autoloader to home position

Calibration

Calibration mode Select type of calibration procedure to run

Calibration type Select human blood or calibrator material

Target values Enter the target ranges for each calibrated

parameter

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Menu Description

Cancel Cancels a calibration procedure

Next Initiates processing of calibration run

View calibrations View and delete previous calibrations

QC

QC measure Initiate processing of a control sample

QC reference select Select which stored QC reference this

measurement belongs to

Set QC reference Create a new stored QC reference

Load QC reference Load QC reference values from removable

media such as a flash drive

Save reference Save entered QC reference values

View QC references Browse stored QC references

Delete Delete a stored QC reference

Details View detailed results for a stored QC reference

View QC data Browse individual QC sample measurements

Delete Delete currently selected QC run

View QC diagrams View QC diagrams to view diagrams for

control measurements

Details View detailed result screen of a QC run

Next diagrams Browse the next set of QC diagrams

View Moving Averages Browse individual Moving Averages sample

measurements

Reject Reject a run from being included in Moving

Averages calculations

View rejected View previously rejected Moving Averages

runs

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Menu Description

Undo reject Restore a previously rejected Moving

Averages run and use in Moving Averages
calculation

View Moving Averages Navigate directly to Moving Averages

diagrams diagrams

View Moving Averages View Moving Averages diagrams of Moving

diagrams Averages data

Diagnostics

Self test Perform electronic and/or pneumatic system

self tests

Load last self test Loads the results of the last self test

Start electronic Starts the electronic tests

Start both Starts both electronic and pneumatic tests

Log Review and obtain additional details about

events in the system log

Details Display details about the selected event in the

event log

Self test Navigates directly to self test screen

Reagent status Reset levels for individual reagents and waste

(or all) for reagent replacement

Statistics Provides operating statistics such as cycle

counts, errors, etc.

Information Provides version information for all software

items in the ADVIA 560 Hematology System

Collect Creates a collect file with information about

the analyzer for troubleshooting

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System Operation ADVIA 560 Hematology System

Safety Access Codes

Some functions require password protected confirmation. For example,
deleting a record from the database requires a password. The default
security password for deleting database entries is: 555.
The system prompts for a confirmation password. The confirmation
password can be changed by your distributor or local service provider.

Sample Measurement
In this chapter you will find information about the samples usable with the
ADVIA 560 Hematology System instrument.

Supported Sample Tubes Types

The ADVIA 560 Hematology System supports the following EDTA, sample-
tubes:
• Sarstedt Monovette 13x75mm with tube adapter 5
• Becton Dickinson (BD) Hemogard Vacutainer 13x75mm with tube
adapter 5
• Terumo Venosafe 13x75mm with tube adapter 5
• Sarstedt Multivette 600 K3E with tube adapter 6
Use only sample tubes containing EDTA K2 or K3 anticoagulant.

CAUTION
Sarstedt Monovette sample tubes have a false bottom that is not the
same as the bottom of the sample tube. The sampling depth on the
ADVIA 560 Hematology System must be changed for a Sarstedt
Monovette sample tube.

To change the sampling depth for manually presented Sarstedt Monovette

tubes at the sample rotor:
1. Check the Use only Sarstedt Monovette tube from sample rotor check
box in the Main menu > Settings > System panel.
2. The AutoSampler automatically recognizes Sarstedt Monovette tubes
and automatically changes the sampling depth.

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Open or Closed Sample Tubes

The ADVIA 560 Hematology System can process both open and closed
sample tubes in manual mode using the sample rotor. Manually presented
sample tubes must be mixed properly before being presented to the
ADVIA 560 Hematology System.
Only closed sample tubes will be automatically processed by the optional
Autoloader. Open sample tubes placed in the Autoloader will be skipped
and not processed.

Sample Collection and Handling

BIOHAZARD
Handle all samples as potentially infectious material and treat as a
biohazard.

Consider the following information when collecting and handling blood

samples:
• The ADVIA 560 Hematology System aspirates 110 μL of sample in both
closed and open vial modes. Under the following conditions, the
ADVIA 560 Hematology System may aspirate less than 110 μL of
sample, but will detect and flag any inadequate sample aspirations:
○ The sample tube does not vent properly and contains residual
vacuum
○ The viscosity of the blood is very high
• Ensure that the sample tube is filled to the sample level line indicated
by the tube manufacturer. The anticoagulant not only prevents the
coagulation of blood, but also dilutes it. If the volume of blood is too
low, than this dilution can adversely affect measurement results.
• Ensure that the blood and anticoagulant are properly mixed by
inverting the sample at least 8 times. Do not shake the sample as this
could damage blood cells.
• A minimum of 30 minutes should elapse between taking the blood
sample and running the sample on the ADVIA 560 Hematology System
for analysis to ensure that the interaction of blood and anticoagulant
has fully stabilized. Check the data sheet of the sample tube for the
exact period of time.
• Use only EDTA K2 or K3 anticoagulated fresh whole blood as sample.

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System Operation ADVIA 560 Hematology System

• Analyze blood samples within 7 hours of collection.

• Samples should be analyzed at room temperature.
• Do not deliver or store the samples at temperatures above normal body
temperature.

Sample Types and Modes

The ADVIA 560 Hematology System processes the following sample types
and provides associated information:
• Whole human venous blood to determine the hematology parameters
of the blood
• Quality control (QC) materials for quality control purposes
• Calibrator materials for calibration of the hematology parameters
QC samples are artificially modified human or human and animal blood
samples with known parameter values. QC samples can be stored for a
period of time as indicated by the manufacturer.
The ADVIA 560 Hematology System works in the following modes. The
sample mode must be selected before a measurement starts:
• Blank mode: No sample need be presented to run a blank. Blank mode
checks that the measuring system is operating correctly and that blank
measurement results are acceptable.
• Human blood mode: Choose one of the human blood modes (Human,
Control, Male, or Female). Each mode has a unique set of normal
ranges associated with it.
NOTE: Alternate 1 and Alternate 2 are sample modes that are different
than Human, Male and Female, and have user-definable normal
ranges.
• Control (QC) mode: The hematological parameters of QC materials are
known prior to analysis. Controls are used to check the long term
stability of the ADVIA 560 Hematology System.
Calibration with a calibrator material is not one of the
ADVIA 560 Hematology System sample modes, but a specific procedure
that can be accessed from the Calibration icon on the main menu.

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Sample Identification
CAUTION
Use caution to ensure accurate data entry when manually entering
sample ID or patient ID information into the
ADVIA 560 Hematology System to avoid possible misidentification of
sample results.

The following sample information items are used to uniquely identify

samples:
• Sample Mode
• Measurement date and time: assigned automatically by the
ADVIA 560 Hematology System
• Result ID: unique database identifier automatically assigned by the
ADVIA 560 Hematology System
• Sample ID: assigned by the operator
○ The ADVIA 560 Hematology System does not require the sample ID
to be unique. Good laboratory practices should be followed when
assigning sample IDs

○ The sample ID can be submitted by:

• Manual typing
• Bar code reading (manual or Autoloader)
• Auto-increment
○ The sample ID is not applicable on blank measurements
• Patient:
○ A record from the patient database connected to a measurement
○ Not applicable for blank and QC measurements
○ Can be changed by setting the name or the database identifier of
the patient displayed with the measurement results
○ The default patient (ID =1) patient is used if no patient is selected

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System Operation ADVIA 560 Hematology System

Running Samples
The ADVIA 560 Hematology System supports both manual and automatic
sample presentation modes. Automatic sample presentation requires the
optional Autoloader. The ADVIA 560 Hematology System software
automatically detects and initializes the Autoloader.
Before performing any measurement the ADVIA 560 Hematology System
should be:
• Powered up and started
• The pneumatic system initialized and a blank measurement performed
and accepted
This section specifies recommended quality control material and quality
control frequency for the individual method. In general, Siemens
recommends that the ADVIA 560 Hematology System be monitored using
the ADVIA 560 Controls (Low, Normal, and High), SMN 11170854. Control
materials should be assayed at the beginning of each shift or at some other
interval chosen by the laboratory, after a reagent lot number change, and
after replacement of any part or component of the analytical module that
may affect analytical performance. The laboratory must evaluate all control
results before reporting patient results. If control results fail to meet the
laboratory's established criteria for acceptability, all patient test results
obtained in the unacceptable test run must be evaluated to determine if
patient test results were adversely affected. The laboratory should take and
document appropriate corrective actions, which may include recalibration
and re-assaying of patient samples, before reporting patient results.

Manual Mode
NOTE: To use Sarstedt Monovette manually presented tubes at the sample
rotor, check the Use only Sarstedt Monovette tube from sample rotor check
box in the Main menu > Settings > System panel.
1. Tap the Measure icon at the top left of the screen to initiate a manual
measurement.
NOTE: To review the results of the previous measurement tap Last
Measure at the bottom left of the screen. This feature can be useful
when a batch is interrupted during measurement, and needs to be
double-checked which sample is processed last.
2. Select a Sample ID.
The system can auto-generate a sample ID. If the Auto-increment mode
check box is selected, the system increments the last sample ID after
each analysis cycle automatically.

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3. Select a sample Mode.

4. Enter Patient Unique No. (a mandatory field).
5. To start a measurement cycle tap Start.
The status light changes to red to indicate that a run is in progress.
When the measurement results are available, the result screen is
displayed. See the Result Interpretation section in this chapter for more
information about the results screen.
After the ADVIA 560 Hematology System has finished cleaning the
pneumatic system, the status light changes to green—ready for the
next sample.

Result screen options

• Tap the Print icon at the top of the screen to print results. Note that the
printing feature is always available.
• Tap Back to return to the measurement screen.
• To run the next sample in the same mode:
a. Edit the Next sample ID just below the actual results.
b. Accept the auto-generated sample ID.
c. Tap Start.
NOTE: In the patient and sample modes the ID is carried over from the
previous sample unless an operator changes the ID.

Automatic Mode of Auto-loader

Only human samples in closed sample tubes can be processed in automatic
mode from the Auto-loader. QC samples and open sample tubes must be
processed in manual mode.
1. After starting up the system, tap the Measure icon at the top of the
screen. An automatic blank cycle starts if there was no blank
measurement processed and accepted before, or if an earlier blank has
expired due to inactivity.
2. Tap the AS icon (Auto-loader) at the top of the screen.

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Four different modes are available for automated sample measurement:

Automated Mode Description
Full Scan mode Auto-loader scans the entire sample tray.
• Selected same sample mode (e.g.,
Human, Male, Female) is used for all
samples.
• Sample ID for each sample vial is
generated from the sample tube barcode
(if available).
• It is not possible to assign a patient to
samples that have been automatically
processed. Default patients are used for
all samples.
Free List mode The Free list mode is one in which samples are
defined in a work list received from an LIS.
Barcode labels are not the sample primary
identifiers.
The following parameters can be individually
defined per sample:
• Sample ID
• Patient
• Sample mode
The samples can be placed in the sample tray
in any order.
Empty sample positions are skipped on the
sample tray.
Selected Samples mode Samples can be defined for each physical
position on the sample tray.
Only selected sample positions on the sample
tray are processed. Additional samples are
skipped and missing samples are marked for
later review.
The following parameters can be defined for
each sample:
• Sample ID
• Patient
• Sample mode

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Automated Mode Description

Remote Work list (Free list Samples are defined in a list received from the
mode) LIS.
The samples can be placed in the sample tray
in any order.
Empty sample positions are skipped on the
sample tray.

Automatic Scanning and Processing

Samples are automatically scanned and processed in the following order:
Rack order starting from Rack A is the rack nearest to the front panel of
rack A to rack J the ADVIA 560 Hematology System.
Rack J is the rack nearest to the back panel of
the ADVIA 560 Hematology System.
Sample order for each Sample 1 is the sample closest to the
rack starting from ADVIA 560 Hematology System (sample to
sample 1 to sample 10 the left).
Sample 10 is the sample closest to the right of
Auto-loader tray.
Sample A1 is the first sample processed and
sample J10 is the last one.

Full Scan Mode

Full Scan Mode is used in laboratories where these conditions are found:
• Batches of samples with the same sample mode exist.
• Barcode labels are in use.
An LIS system, rather than the ADVIA 560 Hematology System, associates
patients with sample results.
Sample tubes are skipped if the tube has no cap or if the Auto-loader
cannot determine the tube type.
Aspiration and measurement processes are the same in automatic and in
manual modes.
Progress of the sample tray can be followed in tray view or the list view. To
view individual results for completed samples tap a completed sample.
Patient ID is not editable in Full Scan mode as this field is automatically set
to the default patient.

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Sample ID is not editable because the Sample ID is read from the barcode
label. If the barcode label is missing or not readable, the
ADVIA 560 Hematology System assigns a default sample ID based on
position, and allows manual entry of the sample ID.

Adding Sample Tubes to a Full Scan in Progress

In Full Scan mode you can add more samples to the batch after starting the
automated measurement. An accepted blank is necessary before starting
automatic sample processing.
1. Tap Stop.
2. Tap OK.
3. Insert the new sample(s) into a rack.
4. Open the cover of the Auto-loader.
5. Place the new samples behind the last measured sample.
6. Close the Auto-loader cover.
7. Tap Start.
After restarting the full scan process, the ADVIA 560 Hematology System
moves the Auto-loader to the last processed position and continues
scanning from there.

Free List Mode

Free List mode does not require that samples are matched to exact rack
and sample positions.
The main difference between Free List mode and Full Scan mode is that
Free List mode matches the samples ID on the sample to the correct ID in
the list which was defined and uploaded earlier, and compares their
measurement results to the normal range associated with the sample
mode selected for that sample.

Starting Sample Measurement in Free List Mode

1. Perform and accept a blank measurement if one is needed.
2. Tap the AS (Auto-loader) icon at the top of the screen.
3. Select Free list mode.

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After automated measurement has started in Free List mode it is not

possible to add additional samples to the batch. The Free List mode screen
enables these actions:
• Return to the AS (Autoloader) screen to select a different type of
automated measurement by using the Back function.
• Add or remove list items.
• Define the following parameters for the new list items
○ Measure mode
○ Sample ID
○ Patient ID
• Swap between the tray and list views by using the View list and View
tray functions.
• Tap Start.
As with the Full Scan mode, the Autoloader scans all the sample positions
on the tray and rows. Missing racks are skipped. The Autoloader processes
only those sample tube types it recognizes with caps attached.
NOTE: It is not necessary to put the samples to the Autoloader in the same
order as the list containing the samples. During measurement, the Auto-
loader reads the barcode ID of the sample and automatically matches the
results of the sample with the same ID in the list.
If there is no barcode on the sample, the system warns the user after the
final sample was found and measured. A missing ID can be set to a sample
at the end of the Free List process. The ID can be typed by the user by
tapping Sample ID label. If the sample has no ID and the user types an ID
which is already in the list, the system pairs the sample results with that ID.
It can happen that there are more sample IDs set in the list than sample
tubes available in the rack. In such a case, after all the sample tubes have
received their ID number (from the user or the automatic system), the IDs
that are without a matched sample tube are ignored and disappear from
the list.
If the automated processing is interrupted for any reason, it can be
restarted it by tapping Start.

Selected Samples Mode

Used in laboratories in these conditions:
• Barcode labels are used.
• In a given batch, there are samples which are to be measured using
different modes for different normal ranges.

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Prior to measurement in Selected Sample mode, an accepted blank

measurement is required as with all sample processing.
This mode can also be used to rerun only certain samples in a sample tray
which have already been processed in one of the other two modes.
Samples cannot be added to the sample tray once automatic processing is
started in Selected Samples mode.
In Selected Samples mode, the ADVIA 560 Hematology System looks for
samples only in those sample positions that are selected for analysis. Any
samples that are in sample positions that have not been selected are
ignored. If a sample position is selected for processing but contains no
sample tube, that sample position is marked for review.
The Selected Sample mode screen enables these actions:
• Return to the AS (Auto-loader) screen to select a different type of
automated measurement by using the Back function.
• Define the samples to be measured:
a. Tap the sample tray position icon where the selected sample is
located.
b. Select the appropriate measure mode.
c. Define the sample ID.
d. Define the patient ID.
e. Tap Add to save changes.
• Tap Remove.
• Swap between the tray and list views by using the View list and View
tray functions.

Remote work list

The remote work list (free list) works the same way as the Free List. In this
mode, the ADVIA 560 Hematology System receives the sample list from
the LIS. This option is available when LIS is activated in settings.
This mode enables to identify and send a sample list from a remote
workstation or lab and the operator only need to insert the samples into
the Autoloader. As in the Free List mode, the sample order is not important
in the tray.

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Supported Bar Code Symbologies

Some of the ADVIA 560 Hematology System analyzer automatic processing
modes use the bar code on the sample tube to determine the sample ID of
the sample tube. The following bar code symbologies are supported by
Autoloader bar code reader:

Bar Code Symbology Checksum Status

Code 128 Uses check digits

Code 39 No check digits used.

If check digit are present they are considered
part of the sample ID

Interleave 2 of 5 No check digits used.

If check digit are present the check digits are
considered part of the sample ID

Codabar Uses check digits

Code 93 Uses check digits

The use of bar code symbologies with check digits identify incorrect bar
code reads in the unlikely event that the Autoloader bar code reader
incorrectly reads the sample tube bar code. Siemens recommends the use
of bar code symbologies that uses check digits to help prevent sample
misidentification.

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Symbols of sample types in tray view:

Sample (in position 6) has bar code and cap. Auto

sampler finished the mixing.

Sample (in position 5) has bar code and cap. Sample

is currently measured.

Sample (in position 4) has bar code and cap. Sample

measurement is finished.

Sample (in position 1) has no barcode but has cap.

Sample measurement is finished.

Sample (in position 2) has no cap. Sample is ignored.

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CAUTION
Incorrect reading of a sample tube bar code without check digits may
result in sample misidentification. Use bar code symbologies with check
digits to prevent this.

CAUTION
The blood sensor is monitoring the sample status during the run of the
AutoSampler. If sample is not detected for 3 times by the blood sensor
(empty vials), the system will stop the autosampler mode to save
reagents.

Interrupting Automatic Processing for Stat Samples

If one or more stat samples need to be processed, you can interrupt
automatic processing to analyze the stat sample(s) without having to wait
until the entire sample tray has been processed. To interrupt automatic
processing for stat specimens, perform the following steps:
1. Select or tap Stop.
The ADVIA 560 Hematology System prompts you to wait until the
current sample completes.
2. Acknowledge the message by selecting or tapping OK.
3. Place the stat sample into the sample rotor.
4. As soon as the current measurement completes, change to the manual
measurement panel by selecting or tapping the Measure quick-link at
the upper left corner of the screen.
5. Process the stat samples in manual mode.
6. Return to the automated measurement panel by selecting or tapping
the AS quick link.
7. Restart the measurement by selecting or tapping Start.
The ADVIA 560 Hematology System continues automated
measurement from where the processing was interrupted.

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Controlling the Autoloader

Detailed information about the Autoloader is available from the Autoloader
info panel. Double select or tap the Autoloader status in the bottom left
corner of the screen to view the Autoloader info panel.

With this panel, you can command the Autoloader to repeat the last
command, or reset the Autoloader. It views the Autoloader Status, Error
messages with detailed information about the last action or sample tube
processed.
The following is a list of messages from the Autoloader:
• Home message:
○ Response after a successful reset
○ +HOME_XX.YY (The XX.YY is the software revision number)
• VT zzzzzzz XY:
○ Vacutainer style tube detected
○ Barcode content: "zzzzzzzzzzz"
○ Tray position XY
• MV zzzzzzz XY:
○ Monovette style tube detected
○ Barcode content: "zzzzzzzzzzz"
○ Tray position XY
• +F : confirmation that the tube was moved from the mixing to the
sampling position (Fetched)
• The power-on message contains the serial number of the Autoloader
unit
During the reset cycle the Autoloader moves the Autoloader components
to their home position. The mixing stations moves to an upright position,
the active rack moves back on to the sample tray, and the entire tray
moves to its home position.

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Result Display
After the analysis is completed, the result screen displays all measured
parameters, flags, histograms and scatter plots. This information is
automatically stored in the database, and stored result data can be
retrieved at any time from the database.
Histograms and scatter plots can be zoomed for closer inspection by
selecting or tapping. Select or tap the Close button on the upper right
corner of the image to close and return to the result display.
Comparison of parameters to the normal range can be displayed
numerically or graphically. Other kinds of flags are also displayed in the
result screen.

Printing Reports
Select or tap the Print icon at the top of the screen to send a report (or any
displayed screen) to the external printer.

The Measurement Process

The ADVIA 560 Hematology System measures 21 parameters of whole
human blood samples. Internal dilutions are made to allow measurement
of particles in the sample. Manual or automatic mode samples are
processed in the same way.
When you present the sample tube and select Start, the
ADVIA 560 Hematology System rotates the sample rotor and takes the
sample tube inside the analyzer. The piercing needle pierces the sample
tube cap (if present) and aspirates approximately 110 μL of primary blood
sample. Blood sensors ensure that the primary blood sample is continuous
and free of major bubbles as the sample moves to the shear valve. The
shear valve separates the primary sample into further samples of exact
volumes of blood that are distributed to provide dilutions for the RBC, WBC,
HGB and WBC 5 DIFF population measurements. Lysing reagents are used
to eliminate RBCs for dilutions that measure WBCs.
RBC/PLT and WBC are measured with impedance technology through 70
and 80 μm apertures respectively. Two portions of the sample are used for
determining a five subpopulation differential of WBC in two independent
4-DIFF and BASO measurements.
Sample results are displayed on the screen as the process is nearing
completion. Results are stored in the internal database and transmitted to
an external LIS if configured to do so. The ADVIA 560 Hematology System
performs a cleaning rinse of the internal pneumatic components and
prepares to measure the next sample.

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Result Interpretation
This chapter provides description about interpreting and understanding
reports provided by the ADVIA 560 Hematology System.

The Result Screen

The ADVIA 560 Hematology System result screen is divided into 4 major
areas:

Figure 12: Result Screen

1 Sample identification information: contains identifying information used

to uniquely identify this sample’s information.
2 Parameter information: contains parameter names, values, units, and
normal range. Normal range, linearity, and high blank flags are also
displayed in this area.

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3 Histograms and scatter diagrams: Visual elements that provide

information about the measured population dispersion. These are active
elements that can be individually magnified by clicking or tapping.
4 Flags area: this area displays warning, interpretive, and morphological
flags associated with this sample. If flag display overflows its assigned
space, an ellipsis will be displayed and the user can click on the
information icon to see a detailed display of flags.

Sample Identification Information

This part of the results screen contains information that uniquely identifies
a particular sample run.

Identifier Description

Sample ID The Sample ID is the ID entered by the operator from

a keyboard or hand-held barcode reader for a
manually processed specimen. For automatically
processed specimens, the sample ID can be read
from a sample tube barcode or entered into a list for
one of the automatic processing list modes. Sample
IDs can be reused in the
ADVIA 560 Hematology System, but other identifying
information together with the sample ID uniquely
identify the sample run.

Patient ID This is the patient associated with this sample run. If

none was entered or selected, the default patient ID
is set to 1.

Run Date/Time This is the time and date that this sample was run.

Sample Mode This is the sample mode selected for this specimen.
Each sample mode applies a different set of normal
ranges to this sample run.

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Parameter Information
The parameter information area of the ADVIA 560 Hematology System
result screen lists information on 21 parameters.

Figure 13: Parameter Information

Each row shows the parameter name, value, flags (normal range, linearity
range, and high blank), units, and normal range. The unit area displays the
differential percentage for the five leukocyte subpopulations (NEU, LYM,
MON, EO, BASO).
Parameter names are listed with their standard abbreviation. Parameter
values are always displayed according to their selected unit. In case of error
during sample evaluation, the software will display ' --- ' sign to indicate the
problems. Parameter values falling within the normal range are un-flagged
and displayed with black text. Parameter values falling above the normal
range are marked with a H and displayed with red text, and values falling
below the normal range are marked with a L, and displayed in blue text.
Normal range information can also be conveyed graphically as well as
numerically. This setting can be changed in the Main menu/Settings/
Customize panel.

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The flags displayed in the parameter information area are as follows:

Table 1: Normal Range Flags

Normal range flags are raised when a particular parameter is above or

below the normal range, which is defined for the patient profile.
Flags Meaning Color code
L Parameter is under Profile Blue
Limits value
LL Parameter is under Panic Blue
range value
H Parameter is over Profile Red
Limits value
HH Parameter is over Panic range Red
value

Table 2: Linearity Range Flags

Linearity range flags are raised when a particular parameter is above or

below the linearity range of the device.
Flag Meaning Color code
* The related parameter is out N/A
of the linearity range
** The related parameter is out N/A
of the display range

Table 3: High Blank Flags

A high blank flag is raised when the blank measurement result of the
particular parameter was higher than the blank.
Flag Meaning Color code
* The blank value of the related N/A
primary parameter is high.

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Scatter Diagrams and Histograms

Scatter Diagrams (4-DIFF and BASO)
The ADVIA 560 Hematology System displays the results of optical
measurements in scatter diagrams. Scatter diagrams represent
2-dimensional distribution data.
The two scatter diagrams in a patient report,4-DIFF and BASO, display
different types of white blood cells.
4-DIFF scatter diagram displays cells identified after the lysing and optical
measurement process. Due to the measurement technology, cells are
classified based on their optically detected properties, low and high angle
scattered light. The optical sensors can measure the intensity of the light
scattered or diffracted by each cell.
A portion of this scattered light- the Y axis-is proportional to the cell size,
while another portion-the X axis-is proportional to the cell complexity.

Figure 14: Scatter Diagrams (4-DIFF and BASO)

Cells in a leukocyte sub-population have similar light scattering properties,

allowing them to be grouped together and identified separately from other
cell types. Different colors are used to identify various populations of blood
cells.
BASO scatter diagram shows the BASO population separately (in pink) from
all the other types of white blood cell, which are shown in blue.

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RBC and PLT Histograms

RBC and PLT are measured by the impedance method, and their
populations are represented by histograms.
• The histograms show the number of cells on the Y axis, and the cell size
on the X axis.
• Smaller cells are displayed on the left side of the histogram, and larger
cells are displayed on the right side.
• The height of the histogram at a given size represents the relative
number of cells at that size. Greater histogram height indicates more
cells.
Both the RBC and PLT histograms can be zoomed. Discriminators
(thresholds) are displayed in red. Platelets are located on the left-most part
of the RBC histogram to the left of the red discriminator. The PLT histogram
is a magnified version of this region.

Figure 15: RBC and PLT Histograms

Flags
The warnings area of the result screen shows flags and messages related to
the evaluation of the sample. Selecting or tapping on the individual
sections of the results screen displays a detailed warnings panel. Select or
tap OK to close the detailed warnings panel.
The ADVIA 560 Hematology System provides Warning flags, Morphological
flags, and Interpretive messages in the Warnings panel. The following
tables describe these flags and messages in detail. The table also provides
guidance on actions to correct the problem described by the flag.

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Table 4: Warning Flags

Flag Meaning Cause Action

A 4 Diff Alarm The 4-DIFF populations If other parameters predict a normal
are not clearly sample, perform a cleaning procedure
distinguishable on the and repeat the measurement.
scatter diagram If not all the parameters reported or the
sample is predicted as pathological,
perform a manual count on a stained
smear.
B WBC blank is WBC > WBC blank high Visually inspect reagents for
high limit particulates.
Perform cleaning of the
ADVIA 560 Hematology System.
Repeat blank measurement. (See
Chapter 2, Pneumatic System Start and
Blank Measurement.)
b RBC blank is RBC > RBC blank high Visually inspect reagents for
high limit particulates.
Perform cleaning of the
ADVIA 560 Hematology System.
Repeat blank measurement. (See
Chapter 2, Pneumatic System Start and
Blank Measurement.)
C WBC Drift in the probe Check the reagent connections.
clogging voltage of the WBC Perform a cleaning procedure. (See
capillary. The two main Chapter 6, Maintenance.)
reasons for this drift are
Repeat the measurement.
the misconnected
reagent and the
clogging of the
capillary.
c RBC/PLT Drift in the probe Check the reagent connections.
clogging voltage of the WBC Perform a cleaning procedure. (See
capillary. The two main Chapter 6, Maintenance.)
reasons for this drift are
Repeat the measurement.
the misconnected
reagent and the
clogging of the
capillary.

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Flag Meaning Cause Action

D MON - NEU The MON and NEU If other parameters predict a normal
alert populations are not sample, perform a cleaning procedure
clearly distinguishable and repeat the measurement.
on the scatter-gram If not all the parameters reported or the
sample is predicted as pathological,
perform a manual count on a stained
smear.
E EO - NEU The EO and NEU If other parameters predict a normal
alert populations are not sample, perform a cleaning procedure
clearly distinguishable and repeat the measurement.
on the scatter-gram. If not all the parameters reported or the
sample is predicted as pathological,
perform a manual count on a stained
smear.
F Differential More than 100 cells Check cleanliness of the reagents and
blank high detected during the the ADVIA 560 Hematology System.
4-DIFF-blank procedure. Perform flow cell cleaning of the
ADVIA 560 Hematology System.
Repeat blank measurement. See
Chapter 2, Pneumatic System Start and
Blank Measurement.
f BASO blank More than 100 cells Check cleanliness of the reagents and
high detected during the the ADVIA 560 Hematology System.
Baso- blank procedure. Perform flow cell cleaning of the
ADVIA 560 Hematology System.
Repeat blank measurement. See
Chapter 2, Pneumatic System Start and
Blank Measurement.
H HGB blank Last accepted blank Check cleanliness of the reagents and
high result: HGB ≥ 1.0 g/dL the ADVIA 560 Hematology System.
Perform cleaning of the
ADVIA 560 Hematology System. Repeat
blank measurement. See Chapter 2,
Pneumatic System Start and Blank
Measurement.

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Flag Meaning Cause Action

I PLT URI The PLT-RBC gap is not Check the sample quality.
clearly detectable on the Repeat the sample.
PLT-RBC histogram:
If the problem persists, perform a
small MCV, fractured
manual count on a stained smear.
RBC-s, aggregated PLT-s
(cold blood), side-effect
of blood-transfusion.
M Out of RBC The RBC coincidence is Check the sample homogeneity.
linearity over the limit: too high Repeat the sample with manual pre-
range RBC count. dilution.
m Close to RBC The RBC coincidence is Repeat the sample with manual pre-
linearity close to the limit: too dilution.
range high RBC count.
N High angle The flow in the optical Perform a blank measurement.
noise head is not clean or If noise still appears, perform a flow cell
contains bubbles. backwash.
n Low angle The flow in the optical Perform a blank measurement.
noise head is not clean or If noise still appears, perform a flow cell
contains bubbles. backwash.
O High If any of RBC, PLT or Perform manual pre-dilution of sample
linearity WBC results are higher and re-measure it.
range limit than high linearity
exceeded range limits.
o Low linearity If any of RBC, PLT or None
range limit WBC results are lower
exceeded than Low linearity range
limits.
P PLT blank Last accepted blank Check cleanliness of the reagents and
high result: the ADVIA 560 Hematology System.
PLT ≥ 15 x 103/µL Perform cleaning of the
ADVIA 560 Hematology System see
Chapter 2, Pneumatic System Start and
Blank Measurement.

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Flag Meaning Cause Action

Q MON - LYM The MON and LYM If other parameters predict a normal
alert populations are not sample then perform a cleaning
clearly distinguishable procedure and repeat the
on the scatter-gram. measurement.
If not all the parameters reported or the
sample is predicted as pathological
then perform a manual count on a
stained smear.
S WBC The distribution of the Perform cleaning of the
measure- WBC detection changes ADVIA 560 Hematology System.
ment in time. It points to Check the homogeneity, the
statistics clogging, non- temperature and the coagulation of the
warning homogeneous sample, sample.
cold sample, partial
Check for clots.
coagulation of the
sample. Repeat the sample.

s RBC The distribution of the Perform cleaning of the ADVIA 560

measure- RBC detection changes Hematology System.
ment in time. It points to Check the homogeneity, the
statistics clogging, non- temperature and the coagulation of the
warning homogeneous sample, sample.
cold sample, partial
Check for clots.
coagulation of the
sample. Repeat the sample.

T Blood Blood Sensor was Wait for the system to go to Standby

detector unable to calibrate itself and then run a blank.
error during turning on. During the wakeup process, the sensor
recalibrates.
u BASO high The number of the Repeat the measurement or perform a
BASO population is high manual count on a stained smear.
or there are lyse-
resistant cells in the
sample.
V WBC vacuum There is a (partial) Perform cleaning of the
warning clogging or leakage in ADVIA 560 Hematology System.
the WBC part of Perform a self-test.
measurement system. A
If the problem persists, contact your
faulty/ worn-out pump
local service provider.
can create vacuum
errors as well.

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System Operation ADVIA 560 Hematology System

Flag Meaning Cause Action

v RBC vacuum There is a (partial) Perform cleaning of the
warning clogging or leakage in ADVIA 560 Hematology System.
the RBC part of Perform a self-test.
measurement system. A
If the problem persists, contact your
faulty/ worn-out pump
local service provider.
can create vacuum
errors as well.
W Sampling Blood Detector detected Check sample volume in sample vial.
warning a sample volume that Check sampling process. Re-run
was too small. sample.
X Differential Not enough cells Perform a flow cell cleaning procedure!
error detected during the Repeat the measurement.
4-DIFF WBC If the problem persists, contact your
differentiating. local service provider.
x BASO error Not enough cells If the total-WBC count is below
detected during the 2 x 103/µl, perform a manual count on
BASO WBC a stained smear.
differentiating. Perform a flow cell cleaning procedure.
Repeat the measurement.
If the problem persists, contact your
local service provider.
Y Differential Algorithm error while Repeat the measurement.
percentage distinguishing the If the problem persists on a specific
error WBC-s in the 4-DIFF sample, perform a manual count on a
procedure. stained smear.
y BASO Algorithm error while Repeat the measurement.
percentage distinguishing the If the problem persists on a specific
error WBC-s in the BASO sample, perform a manual count on a
procedure. stained smear.

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Flag Meaning Cause Action

Z WBC noise During WBC count there Perform Clean process.
high is too much (more than Perform Hard Clean process.
10% of the total)
detected pulse on the
first 10 channel of the
255 channel full range.
This may be caused by
lyse resistant RBC,
electronic noise,
contaminated WBC
chamber or
contaminated reagents.

Table 5: Interpretive Flags

Flag Meaning

Leukopenia WBC LL
Leukocytosis WBC H or WBC HH
Neutropenia NEU LL
Neutrocytosis NEU HH
Lymphopenia LYM LL
Lymphocytosis LYM HH
Monocytosis MON HH
Eosinophilia EOS HH
Basophilia BASO HH
Anemia RBC L or RBC LL
Polycythemia RBC H or RBC HH
Microcytic RBC MCV L or MCV LL
Macrocytic RBC MCV H or MCV HH
Hypochromic MCHC L or MCHC LL
Hyperchromic MCHC H or MCHC HH
Anisocytosis RDW H or RDW HH
Thrombocytopenia PLT LL
Thrombocytosis PLT H or PLT HH
Microcytic PLT MPV L or MPV LL
Macrocytic PLT MPV H or MPV HH

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Table 6: Morphological Flags

Flag Meaning Cause Action

G Immature The count in the region Perform a manual count on a stained

granulocytes of (low - high angle smear.
scatter of ADVIA 560
Hematology System)
where the Immature
granulocyte typically
located is > 3% of the
total WBC count.
L Atypical The count in the region Perform a manual count on a stained
lymphocytes of (low - high angle smear.
scatter of ADVIA 560
Hematology System)
where atypical
lymphocytes typically
located is > 1% of the
total WBC count.

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4 Calibration

The ADVIA 560 Hematology System must be calibrated for all parameters.
Siemens recommends the use of ADVIA 360/560 Calibrator
(SMN 11170852). Calibration procedure should be performed:
• Upon installation of the system.
• If there is a significant shift in control values after the replacement of a
critical hardware component or reagent lot, after checking gains.
• Anytime control results and/or moving averages are out of range and it
has been verified that the out-of-control condition is instrument-
related.
• At the 6th month software dialog box system reminder.
The ADVIA 560 Hematology System calibration process consists of running
a commercial calibrator material or a human whole blood sample with
known parameter values multiple times. The known parameter values and
the average values of multiple runs are used to calculate calibration
factors. The new calibration factors take effect once they are accepted by
the operator.
If you are using a human whole blood as a calibrator, the calibration target
values must be measured on a reference analyzer according to applicable
regulations, standards, or laboratory procedures.

Calibration Factors
Calibration factors can be modified directly without running a calibration
procedure. Only the parameters that are traceable to reference methods
are calibrated WBC, RBC, PLT, HGB, MCV, MPV, and RDW-CV.
Limits of the calibration target values are linked to the normal range of the
Human sample mode.

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Manual Calibration
1. Navigate to Home > Calibration > Calibrate.
2. Skip Automatic calibration by selecting Manual calibration mode on
the calibration screen and tapping Next.
The calibration factor screen is displayed for manual entry of
calibration values.
Manually entered calibration values can be accepted in the same way as
calculated factors from calibrator sample runs, and are stored by the
ADVIA 560 Hematology System in the same way.

Automatic Calibration
Before performing automated calibration procedure, ensure that the
pneumatic system is started up and that a valid blank measurement has
been accepted.
1. Prepare a sample tube with calibrator or human whole blood.
Ensure that there is sufficient sample volume for 3 or 7 consecutive
runs.
2. Select Three runs or Seven runs according to your laboratory's
standard practices.
3. Select Calibrate.
4. Select Calibrator for commercial calibrator or Human for whole
human blood used for calibration.
5. Select Control for a calibrator or Human for whole human blood used
for calibration.
6. Enter or upload (using Load reference) the calibration target values
provided with your commercial calibrator or the previously determined
parameter values for human blood.
7. Tap Next to begin the calibration process.
The system displays an empty result screen.
8. Place the calibration material into the sample rotor, and tap Start to
begin calibration.
9. Wait until the screen displays results when measurement is completed.
10. Tap Accept, if the measurement run is acceptable.

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Beginning Subsequent Calibrations

Selecting Start next without accepting a calibration run discards the run.
Selecting Restart without accepting a calibration run discards the run.
Selecting Abort stops the entire calibration procedure and discards all
calibration results.
1. Tap Start next to begin the next calibration run.
The calibration procedure ends when 3 or 7 accepted calibration runs
complete. The calibration factors are calculated and presented in the
calibrator factor screen. The previous calibration factors and the
coefficient of variation (CV) of the sample runs for each parameter are
also displayed.
2. Tap Accept to replace the current calibration factors with the accepted
factors.

Viewing Calibrations
Viewing calibrations allows the review of the system calibration history.
Over time, increasing or decreasing calibration values can indicate a
problem that requires service intervention.

Viewing Calibration History

Navigate to Home > Calibration > Calibration history.
Calibration history is presented in a table view that can be navigated in the
same way as the database screen.

Deleting a Calibration
Any calibration can be deleted. Deleting the actual (last) calibration causes
the ADVIA 560 Hematology System to revert to the previous accepted
calibration.
1. Navigate to Home > Calibration > Calibration history.
2. Tap the calibration to be deleted.
3. Tap Delete.
The system prompts for a confirmation password to avoid accidental
deletion of calibration data. The confirmation password is set by default to
555, and can be changed by your distributor or local service provider.

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Viewing Calibration Results

Navigate to Home > Calibration > View Calibration results.

Viewing Calibration Targets

Navigate to Home > Calibration > View Calibration targets.

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5 Quality Control

This section specifies recommended quality control material and quality

control frequency for the individual method. In general, Siemens
recommends that ADVIA 560 Hematology System be monitored using the
ADVIA 560 Controls (Low, Normal, and High) SMN 11170854. Control
materials should be assayed at the beginning of each shift or at some other
interval chosen by the laboratory, after a reagent lot number change, and
after replacement of any part or component of the analytical module that
may affect analytical performance. The laboratory must evaluate all control
results before reporting patient results. If control results fail to meet the
laboratory's established criteria for acceptability, all patient test results
obtained in the unacceptable test run must be evaluated to determine if
patient test results were adversely affected. The laboratory should perform
and document appropriate corrective actions, which may include
recalibration and re-assaying of patient samples, before reporting patient
results.
By analyzing control materials on a regular basis, day-to-day reproducibility
and general condition of the analyzer can be monitored. Target values and
acceptable (tolerance) ranges for each parameter can be specified for an
unlimited number of QC materials.

CAUTION
Control materials must be used before their expiration date. Always
observe the control manufacturer’s instructions for storage and use.
Control materials must be well mixed before use.

Siemens recommends the use of ADVIA 560 Control Set material. For more
information see Appendix C Reagents.
The ADVIA 560 Hematology System does not limit the number of QC
material lots or the number of QC measurement runs that are stored in the
control database. Each QC measurement run is saved to the selected QC
material lot.
QC lots can be commercial control materials or a whole human blood
sample whose parameter values and ranges are determined by other
means. The advantage of a commercial control material is that is shelf life
is much longer than human blood, allowing control of the analyzer for a
longer period of time.
Controls in the ADVIA 560 Hematology System are processed in manual
mode only. To access the QC panel, select the QC icon on the main menu.

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Setting QC Reference
Before taking any QC measurements, target values and acceptable ranges
must be specified for a QC lot of control material. Tap the Set QC
reference button to display the Set QC panel.
The QC name is the name that will be displayed for selecting the control to
associate with a QC measurement. Enter the identifying information, and
the target values and tolerance ranges for any parameters that are to be
controlled with the ADVIA 560 Hematology System QC system.

Manual Entry
1. Manually enter the target values and tolerance ranges for each
parameter that is to be controlled with the ADVIA 560 Hematology
System QC package insert sheet.
2. Exclude a parameter from the QC procedure by leaving the target value
and tolerance range field empty.
3. Press the Save reference button after completing data entry.

Scanned Entry
1. Scan the ADVIA 560 Hematology System QC package insert
2D barcode.
All target values and tolerance ranges for each parameter are
populated.
2. Check the values loaded against the Assay sheet values.
3. Press the Save reference button after data entry is correct and
completed.
NOTE: Target values and tolerance ranges for each parameter can only be
adjusted when using manual entry.

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QC Measure
Ensure that a valid blank measurement has been run and accepted before
running a QC measurement.
1. Scan the controls barcode or associate the QC measurement to the
correct control material lot by selecting the matching QC name in the
selector below the QC measure button on the QC panel.
2. Place the control material sample tube in the sample rotor and tap
QC measure.
The QC measurement results will be added to the QC database and
associated with matching QC material lot.

Viewing QC References
Tap the View QC References button to see a list of QC lot references stored
in the ADVIA 560 Hematology System control database. Target values and
ranges can be viewed for any stored QC references.

Viewing QC Data
Selecting View QC data displays QC runs stored in the QC database in a
table format that operates the same way as the ADVIA 560 Hematology
System database. QC measurement results have sequential ID numbers.
Option buttons are provided to switch back and forth between viewing QC
data and viewing QC diagrams.

Viewing QC Diagrams (Levey-Jennings)

Select or tap View QC diagrams to see the QC diagrams for control
measurements.
Means, standard deviations (StDev) and coefficients of variation (CVar) are
calculated based on the QC analyses. The dotted lines delineate acceptable
ranges on QC diagrams. Use the selector control at the top of the panel to
view graphical control information for other lots of control materials.

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Viewing Moving Averages Data

The ADVIA 560 Hematology System offers Moving Averages to facilitate
trend analysis of samples run.
For example the MCV, MCH, and MCHC values show the proportion
between the blood components. These values fall within narrow limits in
human blood therefore these values are able to show the drifting of the
device.
The moving average works with batches. There are 20 samples in 1 batch.
The average deviation of the corresponding batch is calculated as follows:
1. Divide the average deviation of the corresponding batch by the number
of the items in the batch (N = 20).
2. Add the square of the resulting deviation to the mean; then the result
represents a point on the diagram.
3. The value of the mean will be changed with all counted average
deviation from the corresponding batch.
The average of the first batch (X) equals the target value. All the average
deviations belonging to the corresponding batch are added to the mean
with correct signs.
The samples are used in calculation chronologically therefore the deviation
points show the deviation from the mean line.

Viewing Moving Averages Diagrams

Viewing Moving Average diagrams displays moving average charts for
MCV, MCH, and MCHC.
Viewing Moving Average data function displays moving average
information in a table format similar to view QC data.

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Testing CAP Survey Material

You can perform a College of American Pathologists (CAP) survey.
1. On the main screen tap the Measure.
2. On the measure screen tap the left arrow for Mode to scroll to Control.
3. Enter an identifier for the CAP sample by tapping Sample ID.
4. On the Sample ID screen, enter an identifier for the sample.
For example, use the keyboard to enter CAP 23.
5. Select Done when finished entering data from the keyboard.
6. Select Start to begin sampling.

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6 Maintenance

Ensure reliable operation by performing regular maintenance. This chapter

describes necessary procedures and steps required to keep your analyzer in
a good operating condition.

CAUTION
Only Siemens service personnel certified in
ADVIA 560 Hematology System service training can resolve major
problems that can occur during operation. Electrical and moving parts
should always be serviced by trained service personnel.

There are, however some maintenance actions the operator should

perform to keep the analyzer in good operating condition.

BIOHAZARD
Any elements inside the analyzer such as tubes, valves, chambers,
containers should be handled as a potentially biologically and chemical
dangerous material. Observe local laws and regulations regarding handling
and during disposal.

Opening the Front Panel

Several components that require regular cleaning and maintenance are
behind the front panel.
Make sure that objects are not placed on top or in front of the analyzer.
Grasp the lower sides of the front panel, gently pushing the sides. Pull the
lower part towards you, lifting up the front panel.

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Upon opening, a lever becomes visible. Make sure to tilt the front panel
upwards so that you can push the lever into the secure position.

Figure 16: Opening the Front Panel

Closing the Front Panel

CAUTION
Do not push down on the front panel while the security lever is in the
locked position.

Gently lift the front panel so that the security support lever can be moved
to the free position.
Gently lower the front panel. When it reaches its lowest position, gently
push on the front side to select the lock-levers in place.

Removing the Side Panels

With the front panel open and secured in the upright position, thumb
screws become visible that fix the side panels to the instrument: 2 in the
front and 2 in the back. The screws are designed to stay on the analyzer to
avoid losing them.
The system valves and measuring chambers are behind the left side panel.
Open the left side panel if chamber cleaning is requested by the analyzer.
The sampling unit, wash head and sampling needle are behind the right
side cover. Open the right side cover if the wash head needs to be cleaned
or replaced.

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When closing the side panels, always make sure to re-tighten the thumb
screws.

WARNING
After opening the system covers, potentially hazardous parts become
accessible such as electronic boards, motors, moving parts, sampling
needle, chambers, tubes, and valves.

WARNING
The sampling needle and other components inside the analyzer may
cause injury or can be damaged if handled incorrectly. Use extreme
caution when operating the analyzer with the front cover open. Running
measurements with an open cover is not recommended due to the risk of
injury. Always wear safety gloves while performing maintenance actions.

User Maintenance
There are 3 user maintenance points inside the ADVIA 560 Hematology
System:
Maintenance Point Description
Shear valve Critical component responsible for correct
sampling and dilution.
Wash head Keeps the sampling needle clean, ensuring
reliable piercing and sampling.
Measuring Contamination-induced problems such as noise
chambers or high blank values can usually be resolved by
cleaning the plastic measuring chambers.

Software Maintenance Functions

Maintenance functions can be accessed by selecting or tapping the
Maintenance main menu item. This opens the maintenance function
panel.
Selecting or tapping any of the function buttons initiates the
corresponding maintenance functions. The maintenance functions are
grouped into the following categories

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Cleaning Description
Bleaching Cleans the diluent buffer and the connecting
tubes with ADVIA 360/560 Hypoclean
CC 100 mL, SMN 11170851 reagent introduced
through the sample rotor. This type of cleaning
does not affect the optical head's flow cell and
its tubing
Flowcell backwash Cleans the optical head and the flowcell by
draining the sheath buffer through the optical
head with a frequently used backflush through
the flowcell, then refills and rinses the system.
Shear valve cleaning Drains the shear valve so the operator can open
it to clean the ceramic valve, then refills and
rinses the system.
Rinse Washes the tubing system with diluent.
Cleaning Cleans the system with ADVIA 360/560
Hypoclean CC 100 mL, SMN 11170851
introduced through the sample rotor.
Hard cleaning Extended cleaning of the system with
ADVIA 360/560 Hypoclean CC 100 mL,
SMN 11170851 introduced through the sample
rotor.
Draining Description
Drain Diff-5P Drains the Diff-5P buffer.
Drain sheath Drains the sheath buffer.
Drain Lyse Drains the Lyse buffer.
Drain diluent Drains the diluent buffers.
Drain All Drains all of the above buffers.
Empty Chamber Description
Empty Mix chamber Empties the Mix chamber (Intermediate step for
RBC dilution).
Empty RBC chamber Empties the RBC counting chamber.
Empty WBC chamber Empties the WBC counting chamber.

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Prime Description
Prime Diff-5P Primes the Diff-5P buffer and tubing with Diff-5P
reagent.
Prime sheath Primes the sheath buffer and optical head with
diluent.
Prime Lyse Primes the Lyse buffer and tubing with Lyse
reagent.
Prime diluent Primes the diluent buffers and tubing with
diluent or primes the entire system with diluent
(the operator is given a choice by the software
maintenance function).
Prime all Primes all reagent buffers with their
corresponding reagents (the operator is given a
choice to perform a full system prime or prime
individual buffers sequentially).
Fill
Fill Initial filling of the system with reagents. This
must be performed PRIOR to first use of the
system after installation or after the system has
been drained for transportation or storage.
Show MS On-Screen keyboard
Show Activating this option shows the touch-screen
keyboard.
Touchscreen
Touchscreen Calibrates the touchscreen by prompting the
calibration operator to tap specific areas of the display.
Use a pointed touchscreen pen to make precise
calibration.
Auto-sampler reset
Reset Initializes the Auto-loader from an error
condition (for example, if the operator opened
the cover of the Auto-loader while the Auto-
loader was running).

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Cleaning the Shear Valve

Clean the inner surfaces of the shear valve regularly to prevent salt
deposits resulting in analyzer malfunction. It is recommended that the
operator cleans the shear valve after every 1200 samples.
Materials required to perform a shear valve cleaning include these items:
• A clean, soft, damp cloth
• A clean, soft, dry cloth
• Lint-free, soft, dry cloth
• Gloves
• Stylet
• Water

BIOHAZARD
The shear-valve comes in contact with the sample blood. Wear gloves
while cleaning the shear-valve. Handle the materials used to clean the
shear-valve as potentially infectious material.

The shear valve is fixed with a screw that can be turned by hand. No
screwdriver or other tools are required.
1. Navigate to Home > Maintenance > Shear valve cleaning.
The system automatically empties the shear valve and connecting
tubing of liquids. A small amount of liquid may remain inside the
tubing and shear valve. When the shear valve and the connecting
tubing are empty, the system displays the following message:
Do not tap OK until the shear valve has been cleaned
and re-assembled!
2. Open the front cover and secure the cover with the latch.
3. Locate the shear valve in the center of the system.

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4. Unscrew and remove the axis screw that secures the shear valve.

Figure 17: Removing the Shear Valve Axis and Opening the Shear Valve

5. Clean the axis screw with water and wipe it dry.

6. Slide off the upper disc of the shear valve.
The ceramic discs may adhere to each other because they are
extremely smooth. If the shear valve has not been in use for a few days,
apply a few drops of water at the contact point of the upper and lower
discs. The salts dissolve in a short time and release the upper disc

WARNING
Some of the tubes connected to the shear valve have a critical length and
position. Do not pull or move the upper disc of the shear valve, as this
might dislodge some of the attached tubes.

7. Gently clean the mating surfaces of the discs of the shear valve, the
housing of the valve and the tube connections.
8. Remove any salt build-up:
a. Use a stylet to push in the dampened and the dry cloths.
b. Apply a few drops of water to soften any hardened deposits.
c. Use a stylet to remove any salt crystals from narrow places.
Note Do not use any sharp metal or hard objects that can scratch
the smooth surfaces of the shear valve.
9. Place the cleaned upper disc on the metal cover plate of the shear valve
mechanics, to prevent tubes from being pulled and dislodged.

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10. Clean the outside of the shear valve, the housing, and mounting parts
of the shear valve.
NOTE: Clean the aligning surface.
11. Ensure that no lint or fibers remain on the smooth mating surfaces of
the ceramic discs.
12. After cleaning the shear valve, housing and surrounding area, gently
put the two discs together.
13. Place the axis screw back into the center of the upper disc.
The spring on the axis hand-screw guarantees the necessary closing
force for the two discs.

Figure 18: Closing the Shear Valve and Re-inserting the Shear Valve Axis

14. Inspect the tube to ensure that the tube between the shear valve and
the needle is horizontal and not bent.
15. Gently tap down and rotate the axis screw clockwise until it clicks into
the lower part.
16. Turn the axis screw until it stops.
17. Clean the area surrounding the shear valve again.
Allow salt crystals and other small debris to fall.
18. Sweep any particles laying on bottom of the
ADVIA 560 Hematology System though the ventilation holes.
19. Close the front door, and remove and dispose of your gloves.

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20. Tap OK when that shear valve cleaning has been completed.

Figure 19: Shear Valve Cleaning Maintenance Function Prompt

The shear valve cleaning maintenance function checks the movement and
end positions of the shear valve.

Cleaning the Wash Head

The wash head cleans the outer surface of sampling needle tip with
diluent. This is a critical function that protects the integrity of sample
results by preventing contamination with previous blood samples. Salt
build-up on the lower surface of the wash head may cause a malfunction
during operation.
The following materials are required to clean the washing head:
• Cotton Swab
• Distilled Water
• Personal Protective Equipment

WARNING
Use extreme caution when working near the sampling needle. The
sampling needle is sharp and can cause injury. Always wear gloves when
performing maintenance on the ADVIA 560 Hematology System.

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BIOHAZARD
All products or objects that come in contact with human blood, even after
cleaning, should be handled as if capable of transmitting infectious
diseases. Wear facial protection, gloves, and protective clothing. Refer to
Protection of Laboratory Workers from Occupationally Acquired Infections;
Approved Guideline–3rd edition, (2005), Document M29-A3, promulgated
by the Clinical and Laboratory Standards Institute (CLSI), for information
about user protections when working with biohazardous material.

1. Power off the system.

NOTE: The instrument must be powered off before proceeding to avoid
injury and to enable the sample rotor door to open.
2. Open and secure the front cover in open position, then locate the
sample rotor.
3. Press the latch in the hole on the left side to unlock the sample rotor.
See Figure 20 to locate the latch and unlocking direction.

Figure 20: Unlock and Rotate Sample Rotor

4. Turn the sample rotor clockwise by hand.

5. Locate and, with a cotton swab and distilled water, clean the bottom of
the wash head. See Figure 21.
NOTE: Do not remove the wash head.

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Figure 21: Wash Head and Sample Rotor

1 Wash head
2 Sample Rotor

6. Turn the sample rotor back to the default position.

7. Close the front cover.
8. Power on the instrument.
The sample rotor door locks into default position.

Software Cleaning Maintenance Functions

Daily cleaning with ADVIA 360/560 Hypoclean CC 100 mL, SMN 11170851
reagent during shutdown helps to keep the
ADVIA 560 Hematology System clean and in good operating condition.
However, blank measurements results may sometimes still be too high
during daily use or calibration.
When this occurs, the Cleaning and Hard cleaning maintenance function
are available to perform additional system cleaning on demand.

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The Cleaning and Hard cleaning software maintenance functions are also
available to perform deeper cleaning of the system tubing and pneumatic
components.
If the blank measurements are still too high after the Cleaning
maintenance function, it will be necessary to perform the Hard cleaning
maintenance function for a more in-depth, thorough system cleaning.
Running several blank measurements may be required after performing
software maintenance cleaning functions to return blank values to within
specifications.
If blank measurements do not return to normal after the Clean or Hard
clean software maintenance functions and after running several blank
measurements, contact your certified service engineer for additional
assistance.

Daily Cleaning As Part of Shutdown

1. Select Exit.
2. Select Shutdown.
3. Select OK then follow the on screen instructions.
The Shutdown function at the end of the daily routine will request that a
sample vial with 2-3 mL of ADVIA 360/560 Hypoclean CC 100 mL, SMN
11170851 reagent with no cap be placed into the sample rotor. The
software shutdown function will clean the tubing in the measurement
system. Once cleaning is complete the system will automatically power off.

CAUTION
Rubber sample caps are not designed for multiple punctures. The
ADVIA 360/560 Hypoclean CC 100 mL, (SMN 11170851) reagent causes
rubber vial caps to harden, releasing small particles that clog the
analyzer. Always remove the rubber cap when performing daily cleaning.

Cleaning
If the system consistently reports high blank values, the measuring
chambers must be cleaned.
1. Remove the cap from a clean, dry empty sample tube. Fill the sample
tube with 2 mL of deionized water and 1 mL of ADVIA 360/560
Hypoclean CC 100 mL, SMN 11170851 reagent. Do not replace the cap
onto the sample tube.

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2. Insert the sample tube with ADVIA 360/560 Hypoclean CC 100 mL,
reagent into the sample rotor.
3. Select or tap the Cleaning button on the maintenance functions panel
in the Cleaning group.
4. Follow the on-screen instructions.
5. Run a blank measurement and ensure the blank measurement values
return to acceptable levels. Re-run the blank measurement a few times
if necessary.

Hard Cleaning (Extended Cleaning)

If the blank values do not return to acceptable levels after performing the
Cleaning maintenance function, repeat the above steps except for
selecting or tapping the Hard cleaning button in step 3 rather than the
Cleaning button. This maintenance function will perform a longer, deep
cleaning of the measurement system, buffers and chambers.
If the blank measurements do not return to normal after performing the
Clean and Hard clean software maintenance functions and running several
blank measurements, contact your certified service engineer for additional
assistance.

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Maintenance ADVIA 560 Hematology System

Reagent Lock and Hardware Key (HK)

The measuring system and analysis software are designed to work with
Siemens reagents. The reagent lock feature allows only Siemens reagents
to be used, thereby ensuring accurate results. Siemens cannot guarantee
optimal performance of the ADVIA 560 Hematology System with
incompatible reagents.
Each ADVIA 560 Lyse reagent container comes with a reagent hardware
(HK) key. The reagent key is stored in an electrostatic plastic envelope
located underneath the tear-out flap on the top of the reagent container
cardboard box.

Figure 22: ADVIA 560 Lyse Reagent Container with reagent hardware (HK)
key

1 Reagent key in an electrostatic envelope

2 ADVIA 560 Lyse Reagent container

Each reagent hardware (HK) key contains a license for 900 measurements.
The system counts the number of measurements performed, and warns
the operator when the number of measurement remaining is 50.
The ADVIA 560 Hematology System ceases performing sample
measurements when measurement credits reach zero. Blank, Calibration,
and QC measurements are included in the overall measurement count.

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Replenishing the Measurement Count

Replace the reagent key before replacing the ADVIA 560 Lyse reagent
container.
1. Remove the old reagent key from the reagent lock slot located on the
right panel.

Figure 23: Reagent Key Slot

2. Remove the new reagent key from the electrostatic envelope and insert
the key in the port.
NOTE: Do not insert a reagent key into a USB port, insert the key only
into the special key slot on the right side of the system.
3. Replace the ADVIA 560 Lyse reagent container.
4. Navigate to Home > Diagnostics > Reagent status and tap Reset
Lyse-5P.
This uploads the new license for 900 measurement credits and resets
the counter for the ADVIA 560 Lyse to 100% (900 credits).

CAUTION
Do not attempt to reuse HK keys. Treat the keys as waste material.
Dispose of the key according to local laws or regulations governing the
disposal of electronic materials or collect the keys for your distributor or
local service provider for recycling.

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7 Troubleshooting

Instrument Diagnostics
The instrument diagnostics section enables the operator to perform
diagnostic procedures, check the operational history of the analyzer, set or
check the status of the reagents and view stored information about the
system.
Tap Diagnostics on the main menu to view the available options in the
Diagnostics panel. Diagnostics provides procedures to aid with
troubleshooting.

Self Test
Initiating a Self Test tests the key functions and components of the
analyzer. The process takes approximately 1 minute. The individually
tested items and their acceptable ranges can be found in Table 7 and
Table 8 . Selecting or tapping any of the individual test items provides
detailed information including the item readings, limits, and comments.
Selecting or tapping the Load last self test button lets you view the results
of the previous self test for comparison.

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Table 7: Self test Item Limits

Big and small buffer times for 0 to 1000 m (0 to 1380 ft.) Altitude
Big buffer time Small buffer time

Generate 3000 to 12000 ms Generate 1 1200 to 3300 ms

Release 3000 to 6000 ms Generate 2 1200 to 3300 ms
Release 700 to 1300 ms
Big and small buffer times for altitude between 1000 and 2000 m
(3280 to 6560 ft.)
Big buffer time Small buffer time

Generate 3000 to 16800 ms Generate 1 1200 to 4290 ms

Release 3000 to 7200 ms Generate 2 1200 to 4290 ms
Release 700 to 1560 ms
Big & small buffer times for altitudes higher than 2000 m (6560 ft.)
Big buffer time Small buffer time
Generate 3000 to 26400 ms Generate 1 1200 to 5940 ms
Release 3000 to 10200 ms Generate 2 1200 to 5940 ms
Release 700 to 2210 ms
Big buffer drift Small buffer drift
Maximum 540 to 560 mbar Maximum 225 to 235 mbar
Minimum 530 to 560 mbar Minimum 215 to 235 mbar
Drift -5 to +15 mbar Drift -5 to +15 mbar
Max vacuum P1 Max vacuum P2
Maximum 550 to 1000 mbar Maximum 550 to 1000 mbar
Time 0 to 6000 ms Time 0 to 6000 ms
Pump Status Null pressures
Pump 1 1 to 1 Sheath -20 to +20 mbar
Pump2 1 to 1 Capillary -20 to +20 mbar
Chamber -20 to +20 mbar
Noise/pulse HGB head
pls/8 sec 0 to 20 pulses HGB dark 0 to 3000 pulses
20000 19990 to 20050 pulses HGB light 3000 to 60000
pulses pulses

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Table 8: Electronics Tests

TCU Temperature Laser parameters

Actual Reference ± 0.2º C Temperature No Specification
(0.35º F)
Sink 0 to 70º C (32 to Laser Power 32 to 128
158º F)
Laser DC Level Reagent lock
Laser off 0.00 to 0.05 V Status UNLOCKED/
LOCKED/NA
Laser on 0.05 to 0.8 mV No specification
Available
measurements
Electrode Battery/Power Supply
Voltage 45 to 55 V Battery Voltage 0.0 to 3.5 V
Current 620 to 680 μA +12 V 11.4 to 13.0 V
Offset -5.0 to 5.0 mV -12 V -13.0 to -11.4 V
Temperature
WBC Pre- None (LSDACQ v3.0)
heater
34.0 to 38.0º C
(LSDACQ v3.1)
LSDACQ No specification

If any of the values falls outside the above limits, the software lists the
errors on the Self Test report screen.

Log
The system log provides information for service or troubleshooting
purposes. The log lists events and possible problems related to operation
or measurements. The log also lists routine events such as log on. If the
multi-user mode is enabled, the user ID of the operator that is logged at
the time an event occurs will also be stored with the log entry.
The selector at the top of the panel filters the log entries by category

Filter Description
All Displays all log entries, no filter
Error Displays only error log entries
Pneumatic Displays only pneumatic system errors
Software Displays only software system errors

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Filter Description
User Displays only user-related log entries
System Displays only system action log entries

The Details button provides more information about the currently selected
log entry. The Self test button provides direct access to the self test panel
in the event a maintenance procedure is needed in response to a log entry.

Reagent Status
The reagent status panel displays the level of each of the on-line reagents
and waste containers. If you change the reagent container, you can reset
the level of the reagent. You can reset the waste container level after
emptying the waste. Reset All lets you reset the levels of all reagent
containers and waste.
The ADVIA 560 Hematology System has built-in reagent consumption
calculators. The calculated level of each reagent is graphically and
numerically indicated on the reagent status panel. The current reagent
levels are also indicated in the status area at the bottom of the screen.
The ADVIA 560 Hematology System notifies the user when any of the
reagents are running low or when the waste container is almost full. If you
receive a reagent low notification, check the reagent container and
replace. Tap the Reset Diluent, Reset Lyse-5P or Reset Diff-5P button
reset the software counters to a full container level.
Similarly, if you receive a notification that the waste is almost full, empty
the waste container and tap the Reset Waste button on the reagent status
panel to reset the software counters to an empty waste container level.
If the reagent-locking feature is activated, remove the old hardware key
and insert the new hardware key provided in the Lyse-5P package before
selecting or tapping pressing the Reset Lyse-5P button. Tapping Reset
Lyse-5P activates the uploading of additional measurement counts from
the hardware key.

Statistics
View statistics by navigating to Home > Diagnostics > Statistics.
Statistics displays cumulative information such as the measurements and
number of error events experienced during operation. Statistical data can
be only reset by a certified service engineer.

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Information
View Information about system components by navigating to
Home > Diagnostics > Information.
The Information window displays the instrument serial number and
software versions of various system components. This data is important for
maintenance purposes, and your service engineer will ask for this
information prior to a service call.
The information panel also contains a Collect button. By pressing Collect,
there is a chance to save a *.gz file to the selected path. This file can be
send to the local service engineer. The file contains valuable information
about the instrument including self test, stress measurement, and the
calibration factors.
If an issue occurs with the instrument, the Collect file helps the engineer to
analyze the problems, check the measurements, and read the log file.
Before tapping the Collect button, load a pen drive to enable the system to
find this external storage after collect button is pressed. After the pen drive
is found, browse to the external drive to save the .gz file.

Autoloader Diagnostics
Explanation of Messages
The error messages that are triggered by ADVIA 560 Hematology System
are displayed in pop-up windows and logged in the system database.
The details of the error are available by selecting Details option.
In the event the AutoSampler has a mechanical issue during the run, the
system displays a Pneumatic error.
This message will not indicate whether the error message originated from
the analyzer or the AutoSampler.
Select Details in the message window for more information about the
error.
The Details window displays multiple messages showing the process that
the system software was running when the mechanical error occurred.
Explanation of the example error screen:
• SAMPLER_WAITSTATE (86) - system was waiting for AutoSampler
• AUTOSAMPLER (166) - AutoSampler is running

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• AUTOSAMPLER_MEASURE (102) - measurement has been started

Process name:
• NEXT_TO_MIXING_AS (65) - Sample mixing was running at the time of
the mechanical error.
For more details, select AS State on the status bar.
AutoSampler Information window provides more details. Detailed
information on the AutoSampler is available from the AutoSampler info
panel. To view the AutoSampler info panel double click or tap the
AutoSampler status button on the bottom left corner of the screen.
With this panel, you can command the AutoSampler to repeat the last
command, or reset the AutoSampler. You can also view detailed
information about the last action or sample tube processed.
Status: Home/ Position /Fetched /Reset/ Loaded /Error
Last error: It displays the latest error
Technical: It displays the current and the four previous messages.
(+Home_2.4: AutoSampler was initialized by Reset)
AutoSampler Info screen monitors normal operation.
Home message:
• Response after a successful reset, the AS mechanics are ready
• +HOME_2.5 (The 2.5 is the software revision number)
+MV 01 100221:
• Monovette tube detected
• Tray position 01 (A2 in tray)
• Barcode content: "100221" Fetch order/message:
• +F: confirmation that the tube was moved (retrieved) from the mixing
to the sampling position.
+NC 02 (No Cap)
• There was a tube in position 02 (A3 in tray) without a cap. The position
is marked with the "No Cap" symbol and the tube is ignored.
+VT 03 100212
• Vacutainer tube detected
• Tray position 03 (A4 in tray)
• Barcode content: "100212"
See Appendix J AutoSampler Error Codes for a list of AutoSampler Error
Codes.

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Barcode Information
See Appendix I for the Autoloader barcode specifications.

Error Messages
The ADVIA 560 Hematology System provides all the necessary software
maintenance functions required to keep the analyzer operating in
optimum working order. Despite excellent maintenance, the analyzer can
still encounter problems where operator intervention is required. The
ADVIA 560 Hematology System software informs the operator of situations
when further help is required. These are called error messages. Refer to
Appendix E, Error Codes for a list of error codes and their meaning.
The ADVIA 560 Hematology System provides additional information in the
form of numerical codes that help the operator to identify the root cause of
the error. These error codes are important for service personnel. They can
interpret the messages and take necessary actions.
If an error message with a code displays, record the code and message and
describe the operation you were performing before the error occurred. This
information helps the service engineer diagnose the problem. The system
stores and displays every error message, but the system cannot describe
the operation you were performing when the error occurred.
When an error comes up, the software usually attempt to offer a solution,
or will try to resolve the problem and retry the current operation. If this
recovery process fails, or the problem continues to occur, please contact
your service engineer.

CAUTION
If a Windows operating system error appears, accept the error message
and repeat the operation. If the error messages appears again, restart the
analyzer. Contact your local technical support provider or distributor.

Low level error messages provide status information about the data
acquisition system and pneumatic system. Each error message includes the
affected part and the area of the equipment. Check this area and part to
find any irregularities like clogging, mechanical problems or blocked
elements. Try to repeat the operation. The system will try to recover from
the failure. If the error continues to occur, please contact your service
personnel.

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Pneumatic error messages

The analyzer software is designed to be error tolerant and recover from
minor problems. However, if some physical obstructions or extreme
operating conditions cause some mechanical parts to behave
unexpectedly, the system will give you an error message.
Selecting or tapping the OK button returns and retries the current
operation. Selecting or tapping the Details button provide you with further
information about the error. It will describe additional conditions of the
failure. The numbers in the second row are important for the service
engineer.

Mechanical Problems
Most mechanical problems arise because of some physical blockage of the
moving parts. Problems caused by severe blocks are usually accompanied
by a grinding noise. The noise is a result of a motor not being able to move,
but this does not usually result in mechanical damage to moving parts.
Typical failure situations can be traced to salt build-ups around the wash
head or the shear valve. Incorrect operation during cleaning of the system,
especially after long inactive periods of time can cause valves or tubes to
get filled with dry salt deposits. These problems can be the source of
dilutor motor noise.
In extreme tube or valve clogging situations the pressure build-up inside
the dilutors can cause some tubes to be released from their connections.
This symptom is not normal, but will not cause damage to the system.
However, contact your service engineer to determine the cause and
resolve the problems.

Sample Rotor (SR) Failures

Grinding Noise And / Or SW Displays SR Error Messages
• The front panel is not closed properly
• The opening is not aligned with the sample rotor door
• There is liquid in the SR, if you can see traces of salt around the SR,
contact your service engineer
• Check the washing head for contamination (blood and/or salt) as
excessive salt build up can prevent the wash head from lifting up
effectively and the sample rotor door can get stuck

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SR Error Appears During Initialization Process:

• Check the washing head for contamination (blood and/or salt)
• Contact your service engineer

The SR Does Not Turn Into The Analyzer Even With Open Front
Panel
• Check the washing head for contamination (blood and salt)

Needle Mechanics, Vertical Motor (Mvert) Problems

The Needle Carriage Keeps Dropping Back (Down) At Initialization

The wash head and surrounding area should be free of salt build-ups
• Salt build up, or thick salt layer at the bottom or on the inside can block
the movement of the needle in the wash head (or the movement of the
wash head around the needle)
• The through hole of the needle in the vertical carriage should be free of
salt.
• Salt around the needle can damage the needle and can influence the
sampling process, sampling quality or amount of sample
• The wash head position relative to the needle and to the SR is not
correct
• The wash head comes down too far, and if lifted, leaves no room for
the SR door to turn
• The vertical rod holding the wash head is not inserted correctly, or was
not pushed up to the maximum, and the wash head is sitting in a low
position

Shear Valve (SV) Related Errors

SV Error At The First Startup

• The SV cannot turn:
○ Ensure that the pull tab has been removed
○ Check free movement by hand (rotate the shear valve)
• The SV is stuck:
○ Try to open the Shear Valve

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Grinding Noise After SV Cleaning (After SV Reinstallation)

• The SV cannot rotate to reach the opto sensor position - check if the
thumb screw is secured correctly and that there is no gap between the
upper and lower discs
• If shear valve is aligned, adjust the opto sensor panel to the opto rods
on the shear valve

SV Leakage
• The upper disc is not sitting well on the lower disc
• Open, and reseat the upper disc
• There must not be any opening left between the closing screw and the
upper disc

Figure 24: Proper Seating of Shear Valve Thumbscrew

Dilutor Errors
• pinched, clogged tube around dilutor or at the rear reagent tubes
• physical obstruction (foreign material)

Priming Problems

The Analyzer does not Prime Liquids

• The respective reagent is out
• Aspirating tube (in container):
○ has fallen off
○ has a leak
○ is broken

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• A reagent buffer is leaking, look for liquid below the analyzer

• Damaged tube in the system, look for leakage, or traces of liquid, and
contact Service

Electronics Related Problems

No Image on Display, No Backlight

Contact your service engineer.

Touch Sensitive Surface Not Working

• Connect an external USB mouse:
○ This allows selecting on the screen elements
○ Contact your local service provider for resolution of the problem.

Touch (select) Is Inaccurate

• The touch screen needs calibration
• Connect an external USB mouse
○ Perform the calibration under Main Menu > Maintenance > Touch
screen calibration.

The Cursor Seems To Be Moving With Good Ratios, but In a Smaller

Area
• Calibrate the touch screen. (use an external USB mouse to access the
function).
• If the problem persists, contact service.

The Analyzer Does Not Power On

• Check proper power connections, and the state of the (small) switch at
the power supply.
• If the above fails, contact your local service provider.

I2C Errors Displayed At Startup

• Contact your local service provider.

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Measurement results related problems

Fluctuating PLT background values
When the workload increases for the ADVIA 560 Hematology System,
running 300 samples a day in 5 hours of continuous operation is possible.
Despite built-in maintenance programs, the system can require intensive
cleaning. If the blank PLT values are increasing and decreasing
unexpectedly, perform a Hard cleaning.
1. On the Main menu, select Maintenance.
2. In the Cleaning area, select Hard cleaning.

Long, smeared population

A long, smeared population with this appearance shows that a key part of
the measurement process is not operating as expected. This could be the
temperature control unit (TCU), the reagents, or the sample mixing.
Possible root causes are:
• The 2 lyse reagents are interchanged
• Check tube connections or container connection

Figure 25: Smeared Cell Population

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8 Data Management

Database Functions
The ADVIA 560 Hematology System database stores all measured data
including sample results, QC, and patient data. Each sample result stored
includes the complete parameter list, histograms, flags, and identifying
data. The ADVIA 560 Hematology System has a data capacity of up to
100,000 total records.
To activate Database panel, clicking or tapping the Database quick link on
the top of the screen will take you to the database view from any screen.
The database can be accessed at any time, even when processing samples
in the background. You can return to the measurement panel anytime to
view ongoing sample measurements.

Database Overview
The ADVIA 560 Hematology System database provides a powerful, easy-to-
use method of storing, accessing, and managing patient and sample result
information. The database of the ADVIA 560 Hematology System is
capable of storing up to 100,000 measurement, control and patient
records.
The database presents information in a table view of rows and columns.
Each row in the database panel represents one sample measurement.
Rows are also called records. Each column in the database consists or
sample identification information or measurement parameter results.
The database information can be scrolled using navigation buttons along
the right and the bottom of the database view, or by a moving a vertical
scroll bar. Database records can be selected individually or in groups.
Detailed result views are available for selected database records. Selected
records can be printed, sent to an LIS and exported into a tab file. Various
sort options are provided for quickly finding results.

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Database records can be exported for storage and backup. Exported

database information can be later imported for review. Imported records
do not become part of your ADVIA 560 Hematology System database. They
are only imported for viewing, but can be sorted, selected, and managed
the same way as with regular data the stored inside the
ADVIA 560 Hematology System database. The
ADVIA 560 Hematology System database displays 2 numerical counters
separated by a slash under the left side of the database table. The left
number is the number of selected rows, and the right number is the total
number of rows in the database.

Scrolling the Database View

The limited size of the interactive database display acts like a viewport into
the large amount of information inside your database. You can scroll the
database view to bring desired information into view.

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1 Tapping or selecting the button advances the display to the first item in
the list
2 Tapping or selecting the button advances the display by one page of
information at one time.
3 Tapping or selecting the button advances the display by one line or one
column
4 The scrollbar: tapping, holding and moving the scrollbar with the tip of
your finger on the touch screen display quickly scrolls information in the
vertical direction. Selecting and dragging with an optional external
mouse achieves the same effect
5 Tapping or selecting the button advances the display by one line or one
column

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6 Tapping or selecting the button advances the display by one page of

information at one time
7 Tapping or selecting the button advances the display to the last item in
the list

Sorting Database Information

The database is sorted by Result ID by default. Clicking or tapping the
following database column headings changes the sort order of the
database records:

Heading Description
Sample ID Sample ID entered by the operator or read from a
sample tube barcode label
Patient Identifier that associates a result record with a patient
records
Analysis Time Time and date this sample tube was analyzed
SEQ Unique sequential identifier assigned by the
ADVIA 560 Hematology System to each record

Selecting or tapping the same column heading again changes the

ascending or descending order of values in the column.

Manual Selection of Database Records

Tapping a row in the database displays a single row. Tapping the row again
deselects the row. Selecting another row deselects previously selected
rows in single selection. Selected rows are highlighted with white text on a
black background.
Checking the Multiselect check box below the left side of the database
table enables the selection of multiple rows. Tapping once selects a row,
but previous selections remain selected unless you select or tap the row
again to deselect. Unchecking the Multiselect check box deselects all
selected records.
Multiple selections are useful for viewing, managing and quickly viewing
statistics of only a few selected records.

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Automatic Selection of Database Records

When the total number of records in a database becomes very large,
manual selection of records can become difficult. The Select by function in
the Manage records panel provides the means to select a group of records
automatically according to their identifying information. See the section
heading on the Select By database function.

Viewing Detailed Results

Multiple selection is also useful for viewing the detailed results of a few
records rather than navigating through the database. After selecting
several records, clicking or tapping the Details button on the database
panel will display the detailed results for the first record in the selection.
Clicking or tapping the Up or Down buttons on the details screen displays
the details of the next record in the selection.

Statistics
After selecting a group of records, click or tap the Statistics button on the
database panel to view the coefficients of variation (CV) associated with
each of the 21 parameters. This function is useful to quickly measure the
imprecision of multiple runs of the same sample.

Managing Database Records

ADVIA 560 Hematology System database management functions are
accessed by selecting or tapping the Manage records button to bring up
the Manage records panel.

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Select By
Click or tap the Select by button on the Manage Records panel to display
the Select by panel. The Select by panel allows you to select a group of
records with dates and Result IDs that match criteria entered into the
panel.
The Select by panel provides various ways to select records. Only one of
the four selection methods can be chosen.

Method Description
Select day Clicking or tapping the Change button displays a
virtual on-screen date keyboard. All records analyzed
on the date entered will be selected.
Select interval The two Change buttons allow entry of a start and end
date. All records on the start date, the end date, and
all dates in between will be selected.
Select all All records in the database will be selected.
Select Result ID Entering one Result ID will select a record with the
same Result ID. Entering two Result IDs will select a
range of records including the start and end Result IDs.

Importing
Clicking or tapping the Importing button displays a blank, modified
version of the database panel.
The database importing panel provides the following options:
• The Import button brings up a panel to select previously exported
database record files to load and view.
• Select by performs the select by database function to select a group of
imported records according to criteria entered by the operator.
• Details views the detailed result information for all or a selection of
imported records.
• Clear removes selected records from the imported records table, but
does not permanently remove the cleared records from the stored
database file.
• Back ends viewing of imported database information and returns to the
ADVIA 560 Hematology System stored database.

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Export
The database export panel allows you to select a directory location to store
records in a selection for backup or reference purposes. To back up all
records in the database, first use the Select by function to select all records
in the database and export the records using the export function.
Clicking or tapping the Export button displays the database export panel.
Introduce a USB storage device (USB hard drive, memory stick, etc.) into an
available USB port on the back panel of the
ADVIA 560 Hematology System. Select the directory to store the exported
data and press the Ok button to start the export.
The file format of exported data is an internal format, and can only be read
and interpreted by the ADVIA 560 Hematology System using the Import
function. Each database record is stored as an individual file with an.rp
extension.

Send to LIS
The Send to LIS button immediately transmits selected database records to
the external LIS according to your LIS settings. The
ADVIA 560 Hematology System is able to transmit all flags related to
measurement using the Ethernet (HL7) LIS. The warning flags, normal
range flags, linearity range flags, high blank flags, interpretive flags and
morphological flags will be transferred with the records.
In case of improper serial LIS connection there will be a warning displayed:
Serial LIS communication error. 0/1 package(s) was sent
successfully.
Press OK and the warning disappears, and the user should try to find the
root cause of connection error by checking the serial cable and the receiver
side or the baud rate setting in the Settings/External Device menu. Note
that the missing acknowledge message can cause a similar error in the
serial transmission.
In case of improper Ethernet LIS connection this warning message will be
displayed:

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Press Retry and the software tries to sending out the actual record to the
receiver (HL7 server). The timeout for record transmission trial is
20 seconds. After the timeout passes, the warning message displays again.
Press Retry again and the record transmission trial restarts.
Press Cancel and the warning disappears, and the user should search for
the connection error by checking the cable or the receiver side or the
connection settings in the Settings/External Device menu.
During manual measurements in case of the Automatic LIS setting is
enabled and there is a transmission problem with the LIS connection, the
LIS warning will be displayed. Every new pending record will be sent into
the HL7 buffer. If the transmission trial is terminated by pressing Cancel,
the HL7 buffer will be emptied.
The Settings/External Device menu can be edited after the last
measurement finishes. After fixing the connection issue the result records
can be transferred manually to the HL7 server from the Database.

Save Tab File

The Save tab file function is used to archive database data to a tab
separated text file. The Save tab file button displays a directory panel
except that the file saved in the selected location is a tab separated text file
rather than a database backup file. Tab separated text files can be loaded
and viewed by a text editor or imported into spreadsheet software.
The filename created by the Save tab file function is generated
automatically in the following format: TAB_YYYYMMDDHHMMSS.txt with
the year, month, day, hour, minute, and second of the time when the
operation started.
To archive database data using this function, insert a USB data storage
device to one of the USB inputs on the back panel of the
ADVIA 560 Hematology System. Select the file location of your USB data
storage device and click or tap the OK button to begin the export.

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Save Raw Data

The Save raw data function saves the raw data information associated with
a selection of database records. Raw data files are only suitable for internal
use by Siemens support. Your service engineer may ask you to save raw
data files to help diagnose a service issue.
A confirmation password is required to save raw data. The default factory-
set confirmation password is 555. This password can be changed only by a
certified service engineer.
Insert a USB data storage device to one of the USB inputs on the back panel
of the ADVIA 560 Hematology System. Click or tap the Save raw data
button on the Manage records panel, then enter the correct confirmation
password. Click or tap the Ok button to display a directory panel. Select the
file location of your USB data storage device and click or tap the OK button
to begin saving raw data.

Delete
The Delete function is used to delete records from a selection permanently
from the ADVIA 560 Hematology System analyzer database. To
permanently delete records, select a group of records and click or tap the
Delete button on the Manage records panel.
To prevent accidental deletion of data, the ADVIA 560 Hematology System
requests the same confirmation password used in the Save raw data
function. After entering the correct password and clicking or tapping the
Ok button, the records will be permanently deleted.
The password to allow deleting records is: 555.

Patients
The ADVIA 560 Hematology System allows the operator to define and store
patients in the patient database during manual measurement. Patients can
also be predefined while creating a list for one of the automatic processing
modes.
Select the Patients icon on the main menu to display the Patients panel.
The Patients panel displays patient information in the familiar table format
of the ADVIA 560 Hematology System database, and operates the same
way as the database panel. Use the New function to define new patients,
and Edit to change existing patient information. Details displays patient
data in a read-only mode.

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The Patient panel can also be accessed by clicking or tapping the Name or
Patient ID field in the Measurement panel. Two additional function buttons
are available if the Patient panel is accessed from the Measurement panel.
The Select ID function associates the currently selected patient to the
sample measurement and returns to the Measurement panel. The Cancel
function returns to the measurement panel without selecting any patient
to associate to the sample measurement.
You can select either Name or Patient ID to be displayed as the patient
identifier in the Measurement panel by changing the settings in the
Patient’s displayed data in the Main Menu/Settings/Customize panel.
The Save function saves any changes made. To discard any changes made,
click or tap the Back button.

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Multi-User Mode
The multi-user mode provides the clinical laboratory manager the means to
control access to the ADVIA 560 Hematology System by ensuring that only
authorized users can operate the analyzer. With the multi-user mode, the
laboratory manager can assign some users the authority to perform critical
system functions such as maintenance and calibration, and restrict other
users to routine activities such as running samples.
The multi-user mode also provides audit tracking of activities by recording
the user ID of the currently logged on user in the event log. Events that are
normally tracked in the event log such as maintenance and calibration will
also store the user ID of the user that initiated the event. Logon and logoff
become new events that are tracked in the system log when the multi-user
mode is enabled.
The multi-user mode is disabled by default, and can only be enabled by
your Siemens certified service engineer. If you want to use the multi-user
mode, ask your Siemens certified service engineer during the analyzer
installation (or at any time) to create the first administrator user with the
user ID and password you provide. The system prompts for a confirmation
password. The confirmation password is set by default to 555, and can be
changed by your distributor or local service provider. This allows you
administrator access to the ADVIA 560 Hematology System and permits
you to create additional users.

Types of Users
The multi-user mode provides two types of users. Administrator users have
access to all system functions except service functions, and a regular user
has access to a limited set of system functions such as running samples.
Your Siemens service engineer creates the first administrator user account
for the laboratory manager. As an administrator user, you can create other
administrator user accounts or regular user accounts.
All administrator users have the same rights and privileges of the original
administrator user, including the ability to create other administrator
users. Use caution in assigning administrator user privileges.

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The following table shows the menu items that are restricted for each user
type.

Item Administrator Regular User

Measure No restrictions No restrictions
Auto No restrictions No restrictions
Sampler
Database No restrictions No access to Delete button in Manage Records
Print No restrictions No restrictions
Menu – No restrictions No restrictions
Patient
Menu – Exit No restrictions No restrictions
Menu – No restrictions No access except Customize button
Settings
Menu – No restrictions No restrictions
Maintenance
Menu – No restrictions No access to Calibrate button
Calibrations
Menu – QC No restrictions No access to Set QC Reference button
No access to Delete button in View QC Data
No access to Reject button in View X-B data
No access to Undo Rejection button in View Rejected in
View X-B Data
Menu – No restrictions No restrictions
Diagnostics

Creating a New User

When the analyzer is started with the multi-user mode enabled, enter your
user ID and password at the login screen.
1. Log on with an administrator account.
2. Tap Add user by administrator.
The Add user panel displays.
3. Enter a new user ID in the User ID text field.
4. Enter the new user password into the Password text field.
5. Reenter the password in the Re-enter password text field.

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6. Assign a user type: administrator or user.

• Tap the Administrator check box for an administrator ID.
• Leave the Administrator check box unchecked for a user ID.
7. Tap Create when you have finished entering the user information.
8. Tap OK.
You can continue to create users, or tap Close to finish adding users.

Deleting or Changing Users

User IDs with a valid administrator account can delete administrator or
regular users. Regular users do not have privileges to create or delete
users.

Deleting a User Account

1. Log on with an administrator account.
2. Tap Menu.
3. Tap Settings.
4. Tap User.
The User Management windows displays.
5. Select the user ID to delete.
6. Tap Delete user.
7. Tap Yes.

Changing a User Account

1. Log on with an administrator account.
2. Tap Menu.
3. Tap Settings.
4. Tap User.
The User Management windows displays.
5. Select the user ID to modify.
6. Change the access:
• Check Administrator to assign administrator rights.
• Uncheck Administrator to change to a user account.
7. Tap Yes.
8. Cancel the change by tapping No.

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System Configuration ADVIA 560 Hematology System

Settings
The ADVIA 560 Hematology System can be tailored to your laboratory’s
needs by changing or customizing system settings such as user interface
language, sound volume, on-screen keyboard active or external Qwerty
keyboard active (or both). Select or tap the Settings icon on the main
menu to access the Settings panel.
The options available on the Settings panel are:
• Customize
• Laboratory
• External Devices
• System
• Units
• Printer
• Profile Limits
• X-B
• User
Selecting or tapping one of the buttons in the Settings panel displays the
selected panel where settings changes can be made. Each panel has a Back
and Save button. The Save button saves any changes made and returns to
the Settings panel, and the Back button discards any changes and returns
to the Settings panel.

Customize Settings
The Customize panel allows you to customize the
ADVIA 560 Hematology System user interface language and other
preferences about the analyzer operation. Click or tap the Customize
button on the Settings panel to access the Customize panel.
On the Customize panel, you can change the following settings:
• Patient’s displayed data – choose Name or Patient ID as the patient
identifier displayed in the Measurement panel.
• Language – select the language that the
ADVIA 560 Hematology System user interface uses to communicate
with the operator. Only English (United States) is available in the US
version of the ADVIA 560 Hematology System.
• Limit style – select Number, Graphical1, and Graphical2 display modes
to change the display method for parameters outside the normal
ranges on the result screens and printed reports.

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• Sound volume – modify the sound volume up or down

• On screen keyboard active – Select whether to use the on-screen
virtual keyboards for displaying information, or an external keyboard.
• QWERTY keyboard – Select the alphabetic or QWERTY style on screen
keyboard.

Laboratory Settings
The Laboratory settings panel allows entry of seven lines of text up to 50
characters of descriptive information about the laboratory such as
laboratory name, address, etc. All non-empty lines are displayed at the top
of every result printout.

External Devices
The External Devices panel allows entry of external LIS settings. The
ADVIA 560 Hematology System supports external LIS communications over a
serial communications link using the Siemens version 3.1 protocol. It also
supports an Ethernet communications link over the HL7 version 2.5
protocol.
The External Devices panel lets you change the following settings:
• Serial field
• Sending port baud rate – select 9600 or 115200 baud for serial
LIS connection.
• Ethernet (HL7 2.5)
• Enable – Ethernet Network communication can be enabled by
its checkbox – ADVIA 560 Hematology System will use an
Ethernet connection rather than a serial connection. The next
fields IP and Port become available by this option.
• IP – the IP address of the external LIS computer should be
entered here if an Ethernet LIS connection is used. IP addresses
consist of four numbers from 0 to 255 separated by periods.
See your IT administrator for more information about the IP
address of your host LIS computer.
• Port – the port number of the external LIS computer should be
entered here, without commas if an Ethernet LIS connection is
used. Ports are a single number between 0 and 65535. See your
IT administrator for more information about the port number of
your host LIS computer.
• Bidirectional LIS – check this check box if the LIS computer will
download lists for one of the list modes for automatic sample
processing.

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• SampleID in OBR2 field – You can enable that the system sends
the Sample ID in an extra field of HL7 record in case of Ethernet
(HL7) LIS transmission
• Common settings
• Send images – Scatter and Histogram sending to LIS can be
enabled by this checkbox
• Automatic LIS – The ADVIA 560 Hematology System will
transmit every measurement result as soon as it is available if
this check box is checked. In case of communication error in the
Ethernet (HL7) LIS the setting will be disabled by user
interaction (pressing the Cancel button for the LIS
communication error pop-up). The setting could be enabled
again entering into the External devices menu and marking as
checked the Automated LIS setting again. During Autoloader
measurements if the Automatic LIS setting is enabled and there
is transmission problem with the LIS connection the LIS
warning message will be displayed. Every new pending record
will be sent into the HL7 buffer. If the transmission trial is
terminated by pressing the Cancel button the HL7 buffer will be
emptied. The Settings/External Device menu can be edited after
the Autoloader session finished. After fixing the connection
issue the results can be transferred manually to the HL7 server
from the Database.

Laboratory Information System Communication Error

• If there is an unsuccessful event using HL7, with the LIS error LIS
Communication error dialog box will be displayed:

• Tapping Retry sends the transmission again. In the event the

retransmission fails, after 20 seconds the warning will be displayed
again.
• If the samples are run in the autoloader mode, the Automatic LIS
setting is disabled. Enable the Automatic LIS setting. Check your host
database to determine which results need to be retransmitted.

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• Tapping Cancel deletes the buffer of any pending results. If the

samples run in the manual mode, the Automatic LIS setting is not
disabled.
NOTE: Consult your information technology staff regarding the
configuration of the host computer and the
ADVIA 560 Hematology System for proper LIS operation. Your information
technology staff person may need to consult your Siemens certified service
engineer to ensure the Internet Protocol (IP) settings of the
ADVIA 560 Hematology System are set properly.
The ADVIA 560 Hematology System listens on port 6600 for incoming LIS
instructions.

System Settings
Navigate to Home > Settings > Laboratory to change various options
regarding the operation and behavior of the
ADVIA 560 Hematology System. System settings change various options
about the operation and behavior of the ADVIA 560 Hematology System.
The System settings panel lets you change the following settings:
• Waste container volume – select 10L, 20L, or None. Selecting 10L or
20L changes the waste container tracking display behavior in the
reagent status area at the bottom of the screen. Selecting None
assumes waste is being drained directly into the laboratory drain and
disables waste container tracking.
• Database display limit – select All or Last month to change the number
of database records displayed in the database panel. Last month only
displays the last 30 days of measurement results, and All displays all
measurement results stored in the ADVIA 560 Hematology System
database.
• Use only Sarstedt Monovette tube from sample rotor – Check this check
box to change the sampling depth for manually presented tubes at the
sample rotor to accommodate Sarstedt Monovette tubes. Uncheck this
check box to manually process standard sample tubes. This setting
does not affect automatic sample processing with the optional
Autoloader, which is able to recognize tube types and change sampling
depth automatically.
• Standby time – This defines the time period of inactivity before the
analyzer automatically leaves the ready state and drains the pneumatic
components to prepare for overnight standby.

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• Offline rinsing frequency – this defines the time period between

automatic fluidic operations to ensure that fresh reagents are available
in critical pneumatic components so that the analyzer can quickly
return to the ready state from standby. If this time is set to zero, the
analyzer will never perform automatic fluidic operations while it is in
standby state, but may increase the amount of time needed to return
to the ready state from standby.
• Screen saver – this defines the time period of inactivity before the
analyzer automatically starts the screen saver. Entering a time of zero
(0) prevents the analyzer from invoking the screen saver.
• Blank request time – defines that time period after the system requests
an accepted blank measurement in order to run further samples. This
periodic quality check ensures that the system condition is checked
periodically.
NOTE: Blank request time warning message shuts off next Offline
rinsing run.
• Special flags (G, L) – selecting the check box enables the generation,
storage, LIS transmission, and display of the G (Immature
Granulocytes) and L (atypical Lymphocytes) flags on the screen and
printed reports.

Units
The Units panel allows the user to choose which units are displayed for
certain parameters.
The following options are available on the Units panel:
• HGB unit – choose g/dL, g/L, or mmol/L to change the displayed units
for the HGB and MCHC parameters.
• Count unit – choose cells/μL, cells/L, or cells/mm3 to change the
displayed units for the parameters in the table below.

Parameter Cells/µL Cells/L

3
WBC 10 /µL 109/L
LYM 103/µL 109/L
NEU 103/µL 109/L
MON 103/µL 109/L
EO 103/µL 109/L
BAS 103/µL 109/L

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Parameter Cells/µL Cells/L

PLT 103/µL 109/L
RBC 106/µL 1012/L

Printer Settings
The Printer Settings panel lets you choose which installed printer to use,
view the status of the printer, and change the print behavior of the
analyzer during operation.
The following options are available on the Printer Settings panel:
• Printer – select an installed printer to use.
• Printer status – indicates the status of the currently selected printer.
• Color printing – check this check box to print in color, or uncheck to
print in black and white.
• Double sided printing – check this check box to print on both sides of
the paper, or uncheck to print on one side only. This option is only
available if your installed printer supports double-sided printing.
• Items in queue – indicates how many printouts are currently waiting in
the printer queue.
• Cancel all jobs – select or tap this button to cancel printing and clear all
items waiting in the printer queue.
• Microscopic Examination – check it to print a form for manual WBC Diff
on printout
• Automatic print – check this check box to print every sample or control
as it is run.
• Logo visible – check this box to print the Siemens logo on every printed
report.
• Pre-printed paper header height – select from 0 to 80 pixels.
• The Print Queue is limited to 10 print commands. When more than 10
print commands are received, the system no longer prints.
• While manually sampling, if you press the printer icon or are using
automatic printing the Automatic print setting is not disabled. The
following error message displays.
There are too many documents waiting in the
printer queue. (warn_PrinterQueuelsFull_Manual)
• If the samples are run in the autoloader mode, the Automatic print
setting is disabled. The following error message displays.

There are too many documents waiting in the

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printer queue. The auto printing will be switched

off. (warn_PrinterQueuelsFull_Auto)
• Check that the printer is functioning properly. The printer will print all
print records in the buffer. If using the Autoloader, re-enable the
Automatic print setting for future samples.

Profile Limits Settings

The Profile Limits settings are used to view and modify the normal ranges
associated with the ADVIA 560 Hematology System sample modes:
Human, Male, Female, Profile 1 to Profile 7.
NOTE: Profile 1 to 7 are sample modes that are different than Human,
Male and Female and have user-definable normal ranges.
The selector switch at the top of the screen selects one of the five sample
modes. The panel is then populated with the lower and upper limit values
for each of the 21 parameters. Modify the values as needed, then select or
tap Save to save the new values and return to the Settings panel, or select
Back to discard any changes and return to the Settings panel.

Panic Ranges
Panic Ranges allows a second set of critical ranges to be customized on the
system. Whereas the first set of out-of-range results are marked as H or L in
the results, Panic Ranges, which are set in the Panic Ranges page, are
marked as HH and LL in results reports.

Moving Averages
The moving averages panel displays the currently selected moving
averages constants. Change the values as needed, then select or tap Save
to save the new values and return to the Settings panel, or select Back to
discard any changes and return to the Settings panel.
The following moving averages settings are available:
• Lower and upper limit – A parameter is usable in moving averages
statistics if its value is between these criteria
• Target – The start value of the first batch in the moving averages
algorithm
Action limit (%) – Maximum percent deviation of the running average
values from the target value. The user needs to check the moving averages
diagrams regularly as no action is performed by the software if the action
limit is reached.

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Multi-User Mode
Multi-user mode provides the clinical laboratory manager the means to
control access to the ADVIA 560 Hematology System by ensuring that only
authorized users can operate the system. With the multi-user mode, the
laboratory manager can assign some users the authority to perform critical
system functions such as maintenance and calibration, and restrict other
users to routine activities such as running samples.
Multi-user mode also provides tracking of activities by recording the user ID
of the currently logged on user in the event log. Logon and logoff become
new events that are tracked in the system log when the multi-user mode is
enabled.
Multi-user mode is disabled by default, and can be enabled only by your
distributor or local service provider.

Types of Users
Multi-user mode provides two types of users. Administrator users have
access to all system functions except service functions, and a regular user
has access to a limited set of system functions such as running samples.
Your service provider creates the first administrator user account for the
laboratory manager. An administrator can create other administrator
accounts and regular user accounts.

Date and Time Adjustment

Double-select or tap the time display on the bottom right side of the screen
to display a time/date settings panel. Change the time and date if needed,
then select or tap the OK button to save the new settings. Select or tap
Cancel to exit the Time/Date settings without saving.
The ADVIA 560 Hematology System does not support automatic time zone
or daylight savings time changes. Please change the time and date
manually when necessary.

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Appendix A: Symbols

This section describes the symbols that can appear on the exterior of the
ADVIA 560 Hematology System system or on the system packaging.
The symbols on the system provide you with the location of certain
components and with warnings for proper operation.
The symbols on the system packaging provide you with other important
information. For information on the symbols that can display on the
automation reagent packaging and labeling, see the related assay
instruction for use.

Symbol Description
This symbol is used for both Warnings and Cautions.
• A Warning indicates the risk of personal injury or loss
of life if operating procedures and practices are not
correctly followed.
• A Caution indicates the possibility of loss of data or
damage to or destruction of equipment if operating
procedures and practices are not strictly observed.

This symbol alerts you to a biohazard.

This symbol alerts you to the risk of exposure to lasers.

This symbol alerts you to a potential electrical hazard.

This symbol alerts you to the risk of corrosive materials.

This symbol identifies the location of a protective earth

(GND) conductor terminal.

This symbol indicates that this equipment is classified as

Waste Electrical and Electronic Equipment under the
European WEEE Directive. It must be recycled or disposed of
in accordance with applicable local requirements.

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Symbols ADVIA 560 Hematology System

Symbol Description
This symbol indicates that the main power supply is on.

This symbol indicates that the power switch is off.

This symbol indicates that the product has a temperature

limitation. In this example, you need to store the product at
5° to 25 ° C.
This symbol indicates that you should consult instructions
for use.

This symbol indicates the number used for ordering a part

or product.

This symbol indicates the serial number of a part or

product.

This symbol indicates the revision letter of a part or

product.
This symbol indicates an in vitro diagnostic device or an in
vitro medical device.

This symbol indicates the name and location of the product

manufacturer.

This symbol indicates the date of manufacture of the

product.

This symbol indicates the manufacturer’s authorized

representative within the European community.

This symbol indicates the batch code for a product.

This symbol indicates a Diluent connection.

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ADVIA 560 Hematology System Symbols

Symbol Description
This symbol indicates a Lyse line connection.

This symbol indicates a waste line connection.

This symbol indicates a cleaning line connection.

This symbol indicates Digital Video Input port.

This symbol indicates a VGA monitor port.

This symbol indicates Ethernet ports.

This symbol indicates communications ports for LIS.

This symbol indicates a line-out jack.

This symbol indicates a line-in jack.

This symbol indicates audio line-in port

This symbol indicates a keyboard port.

This symbol indicates a mouse port.

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Symbols ADVIA 560 Hematology System

Symbol Description
This symbol indicates a USB port.

This symbol indicates that the product complies with the

applicable directives of the European Union.

This symbol indicates that the product complies with

Canadian Safety Standards.(CAN/CSA C22.2 No. 61010-1
2nd edition)

This symbol indicates compliance with the restriction of

hazardous substances used in electrical or electronic
equipment.

This symbol indicates that the input electricity is direct

current.

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Appendix B: Warranty and Support
Information

For customer service or additional information contact your distributor or

local service provider.

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Warranty and Support Information ADVIA 560 Hematology System Operator’s Guide

140 / 202 11316937 Rev. 01

Appendix C: Reagents

Use only Siemens reagents to ensure proper performance of the system.

Reagents are manufactured for in vitro diagnostic use only.

WARNING
Do not allow any reagent to be ingested. If any of the reagents are
ingested, drink water immediately, and seek medical attention. Do not
allow eyes or skin make contact with any of the reagents. If contact is
made, flush abundantly with water.

The ADVIA 360/560 Dil Diluent reagent is a multiple micro-filtered, particle

free buffered isotonic solution, containing stabilizers, special additives and
preservatives.

ADVIA 360/560 Dil (20L) Information

Application Quantitative and qualitative determination of RBC,
WBC, PLT, and HGB concentration.
Appearance Colorless, odorless solution.
Shelf-life 36 months
Open bottle 60 days
stability
Storage Between +15° C and +30° C. (~59–86° F)
Siemens reagent REF/SMN is 11170845
code (ADVIA 360/560 Dil 20L)
Color code Green

The product is environmentally-friendly, and contains neither azide nor

cyanide.

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Reagents ADVIA 560 Hematology System

ADVIA 560 Lyse 5L Information

Description Multiple micro-filtered, particle-free reagent
solution, containing lysing detergents, stabilizers,
leucoprotective components, special additives and
preservatives.
Application Quantitative and qualitative determination of WBC,
5 diff, and HGB concentration.
Appearance Colorless solution, foaming by shaking.
Shelf-life 24 months
Open bottle 60 days
stability
Storage Between +15° C and +30° C. (~59–86° F)
Siemens reagent REF/SMN is 11170846 (ADVIA 560 Lyse 5L)
code
Color code Yellow

The product is environmentally-friendly, and contains neither azide nor

cyanide.

ADVIA 560 5P Diff 1L Information

Description Multiple micro-filtered, particle-free reagent
solution, containing stabilizers, leucoprotective
components, special additives and preservatives.
Application Quantitative determination of WBC, leukocyte
four-part differentiation (LYM, MON, NEU, EOS)
Appearance Colorless, odorless solution.
Shelf-life 24 months
Open bottle 60 days
stability
Storage Between +15° C and +30° C. (~59–86° F)
Siemens reagent REF/SMN is 11170847 (ADVIA 560 5P Diff 1L)
code
Color code Orange

The product is environmentally friendly, and does not contain azide nor
cyanide.

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ADVIA 560 Hematology System Reagents

ADVIA 360/560 Hypoclean CC (100 mL) Information

Description Contains alkaline hypochlorite, special additives,
and preservatives.
Application Washing capillaries, tubing and chambers, and
removing blood component precipitates
Appearance Slightly yellow liquid with chlorine odor
Shelf-life 15 months
Open bottle 60 days
stability
Storage Between +15° C and +30° C (~59–86° F)
Siemens reagent REF/SMN is 11170851
code ADVIA 360/560 Hypoclean CC (100 mL)

ADVIA 360/560 Hypoclean CC (100 mL), SMN 11170851 is not an online-

reagent (not directly connected to the ADVIA 560 Hematology System).
This reagent is aspirated from an open sample tube an operator places in
the sample adapter.

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Reagents ADVIA 560 Hematology System

Reagent Warnings and Precautions

When working with Siemens reagents follow the warnings and precautions
associated with that particular reagent.

Reagent and Symbol GHS Codes Description

Ordering Code
ADVIA 360/560 Dil H317 WARNING!
20L
May cause an allergic skin reaction.

SMN 11170845
P280 Wear protective gloves/protective
clothing/eye protection/face protection.
Contaminated work clothing should not
P272
be allowed out of the workplace.
P302+P352
IF ON SKIN: Wash with plenty of soap
P333+P313
and water. If skin irritation or rash
occurs, get medical attention.
P501 Dispose of contents and container in
accordance with all local, regional,
national, and international regulations.

Contains: 5-chloro-2-methyl-3(2h)-
isothiazolone mixture with 2-methyl-
3(2h)-isothiazolone

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ADVIA 560 Hematology System Reagents

Reagent and Symbol GHS Codes Description

Ordering Code
ADVIA 560 5P Diff 1L H317 WARNING!
May cause an allergic skin reaction.
SMN 11170847

P280 Wear protective gloves/protective

clothing/eye protection/face protection.
Contaminated work clothing should not
P272
be allowed out of the workplace.
P302+P352
IF ON SKIN: Wash with plenty of soap
P333+P313
and water. If skin irritation or rash
occurs, get medical attention.
P501 Dispose of contents and container in
accordance with all local, regional,
national, and international regulations.

ADVIA 360/560 H319 WARNING!

Hypoclean CC 100
Causes serious eye irritation.
mL for hard cleaning
H315 Causes skin irritation. Wear protective
SMN 11170851 P280 gloves/protective clothing/eye
protection/face protection.

P264 Wash hands thoroughly after handling.

P305+P351+ IF IN EYES: Rinse cautiously with water

P338 for several minutes. Remove contact
lenses, if present and easy to do so.
Continue rinsing.

Contains: Sodium hydroxide

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Reagents ADVIA 560 Hematology System

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Appendix D: Reagent Consumption

Function Reagent consumption per function (mL)

ADVIA 560 Lyse (5L) ADVIA 560 5P Diff (1L) ADVIA 360/560 Dil (20L)
SMN 11170846 SMN 11170847 SMN 11170845
StartUp 13.6 1.7 128
Measure Blank, 5.7 0.7 52
Human, QC
Standby 0 0 11.2
Wakeup 1 0 9
Cleaning 6.7 0.7 133
Hard Cleaning 6.7 0.7 144.2
Shutdown 7.7 0.7 153.2

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Reagent Consumption ADVIA 560 Hematology System

148 / 202 11316937 Rev. 01

Appendix E: Error Codes

During normal operation, errors can occur. The ADVIA 560 Hematology
System software runs several procedures simultaneously. The following list
contains error codes with description and explanation. Ensure you record
the error code, message, and tasks you were performing when the error
occurred.
Performing the troubleshooting steps can require the Service account log
on to the system.

Error Messages
Every error message has an option to display the error details. The details
list shows all the tasks that were running when the error occurred or the
tasks that were related to the error. The process names (Task ID) start with
the letters EG to indicate a task or process and not an error. The list
provides details about each task. The service engineer uses this
information to determine which currently running task caused the error.
Every detailed error message lists multiple tasks, but not every task is
responsible for the error. Usually only one of the tasks created an
interruption during the currently running process. Use this list to
determine which task caused the error and which task in the error details
can be ignored.
Ensure you record the error code, message, and tasks you were performing
when the error occurred.

Task code Each task is assigned a unique code and defined as a

number.
Task ID The name of the task that was running when the error
occurred.
Description Describes when the error occurred or the cause of the
error.
Rated (PMC) Tasks are related to 3 types: Pressure (P), Movement
(M) or Control (C).
Pressure (P):
The task and function is pressure or vacuum related.
These tasks occur because the vacuum measured by
the pressure sensors was improper. This can involve
the pressure sensor, valves, tube or pump problem.

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Error Codes ADVIA 560 Hematology System

Movement (M)
The task and function is related to mechanical
movement. These type of tasks occur when one of the
moving mechanisms failed to reach the correct
position. This can involve the XY unit (needle
horizontal and vertical movement) with sample rotor
(BOB), Shear valve movement, and all dilutor
movements.
Control (C)
The task and function is related to a controlling
process in the software or the firmware controlling the
hardware. This can involve LSDACQ or PPB boards,
communication or firmware error. Most of these tasks
are software tasks, which control the processes during
measurement. In most cases Control-related tasks are
not directly responsible for the error.
Troubleshooting Perform the steps to resolve the error. Some
Information troubleshooting steps require service personnel to
perform the tasks.

NOTE: Performing the troubleshooting steps can require the Service

log-on account for the system. The Service menu is not available for
operators.

BIOHAZARD
All products or objects that come in contact with human blood, even after
cleaning, should be handled as if capable of transmitting infectious
diseases. Wear facial protection, gloves, and protective clothing. Refer to
Protection of Laboratory Workers from Occupationally Acquired Infections;
Approved Guideline–3rd edition, (2005), Document M29-A3, promulgated
by the Clinical and Laboratory Standards Institute (CLSI), for information
about user protections when working with biohazardous material.

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ADVIA 560 Hematology System Error Codes

BIOHAZARD
Any elements inside the analyzer such as tubes, valves, chambers,
containers should be handled as a potentially biologically and chemical
dangerous material. Observe local laws and regulations regarding handling
and during disposal.

Task Task ID Description Rated Troubleshooting

Code (PMC) Information and Options
3 EG_PNEU_INIT Initialization failed. PMC Perform a self test:
Error during 1. In Diagnostics, select
mechanics Self Test.
movement or
2. Select Pneumatic tests.
pressure related
problem. 3. Select Start both.
4. When the self test
completes, check the
Pressures area for
Passed or Failed.
5. Contact technical
support.
Technical support may
perform this action to
resolve the issue:
• In Service > Service
Testing, select Test
mechanics.
13 EG_PRIME Error occurred P Interrupted task.
during priming. Check other tasks in error
details or repeat the
process.

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Error Codes ADVIA 560 Hematology System

Task Task ID Description Rated Troubleshooting

Code (PMC) Information and Options
15 EG_MEASURE_PUFFE Vacuum problem in P Perform a self test:
R vacuum reservoir 1. In Diagnostics, select
(leaking or bad Self Test.
valve/pressure
2. Select Pneumatic tests.
sensor).
3. Select Start both.
4. When the self test
completes, check the
Pressures area for
Passed or Failed.
5. Contact technical
support.
Technical support may
request or perform these
actions to resolve the issue:
• Check the glass
reservoir for cracks.
• Ensure the tubing is
connected to the
reservoir.
• Check the tubing for
cracks.
• Check the waste tube
on valve 5.
• Check valve 3 and
replace the valve, if
needed.

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Task Task ID Description Rated Troubleshooting

Code (PMC) Information and Options
16 EG_MEASURE_PUFFE Vacuum problem in P Perform a self test:
R_ SPEC vacuum reservoir 1. In Diagnostics, select
(leaking or bad Self Test.
valve/pressure
2. Select Pneumatic tests.
sensor).
3. Select Start both.
4. When the self test
completes, check the
Pressures area for
Passed or Failed.
5. Contact technical
support.
Technical support may
request or perform these
actions to resolve the issue:
• Check the glass
reservoir for cracks.
• Verify the tubing is
connected to the
reservoir.
• Check the waste tube
on valve 5.
• Check valve 3 and
replace valve, if
needed.
18 EG_TEST_MOTORS Error occurred M Perform a self test:
during motor test. 1. In Diagnostics, select
Self Test.
2. Contact technical
support.
Technical support may
perform this action to
resolve the issue:
• In Service > Service
testing, run Test
pumps.

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Error Codes ADVIA 560 Hematology System

Task Task ID Description Rated Troubleshooting

Code (PMC) Information and Options
19 EG_TEST_VALVES Error occurred P Interrupted task.
during valve test. Check other tasks in error
details or repeat the
process.
20 EG_TEST_PUMPS Error occurred P A problem occurred when
during pump test. measurement started. The
vacuum problem appeared;
possibly during
Initialization.
Verify the pumps are
working.
Perform a self test:
1. In Diagnostics, select
Self Test.
2. Contact technical
support.
Technical support may
request or perform this
action to resolve the issue:
• Check valves V14, V15.
21 EG_PREP_FOR_SHIP Error occurred P Verify that the tubes are
during Preparing for disconnected from the rear
shipment process. inlets of the analyzer unit.
22 EG_CLEAN Error occurred PMC Interrupted task.
during Cleaning Check other tasks in error
procedure. details or repeat the
process.
24 EG_BLANK Error occurred PMC Interrupted task.
during Blank. Check other tasks in error
details or repeat the
process.
25 EG_STRESS Error occurred PMC Interrupted task.
during Stress. Check other tasks in error
details or repeat the
process.

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Task Task ID Description Rated Troubleshooting

Code (PMC) Information and Options
26 EG_EMPTYCHAMBER Error occurred P Perform a self test:
during Emptying 1. In Diagnostics, select
chambers. Self Test.
The system cannot 2. Select Pneumatic tests.
drain one of the
3. Select Start both.
chambers. This error
can be a valve issue, 4. When the self test
pressure sensor completes, check the
issues, or chamber Pressures area for
draining cone issue. Passed or Failed.
5. Contact technical
support.
Technical support may
request or perform these
actions to resolve the issue:
• Clean the chamber
draining cones.
• Check the common
draining valves (V14,
V15).
• Check valve 9 for MIX
chamber.
• Check valve 10 for RBC
chamber.
• Check valve 11 for
WBC chamber.
27 EG_SHUTDOWN Error occurred PMC Interrupted task.
during Shutdown. Check other tasks in error
details or repeat the
process.
28 EG_HARDWARE_INIT Error occurred PMC Interrupted task.
during Init process. Check other tasks in error
details or repeat the
process.
29 EG_PNEUCONTROL Error occurred PMC Interrupted task.
during Check other tasks in error
measurement. details or repeat the
process.

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Error Codes ADVIA 560 Hematology System

Task Task ID Description Rated Troubleshooting

Code (PMC) Information and Options
32 EG_PNEUCONTROL_ Error during the PMC Verify the cables are
INIT hardware Init. connected correctly. The
PPB or LSDACQ may not be
receiving power.
Perform a self test:
1. In Diagnostics, select
Self Test.
2. Contact technical
support.
Technical support may
request or perform these
actions to resolve the issue:
• Check Start.
• In Service > SW
upgrade, select
Refresh.
• Verify all software and
firmware are present.
33 EG_MEASURE Error during PMC Interrupted task.
CONTROL measurement Check other tasks in error
control functions. details or repeat the
process.
34 EG_SV Error occurred M Mechanical error. This
during Shear Valve indicates that a problem
movement. occurred while moving the
Possibly the disk is Shear valve.
stuck or Opto sensor Verify that the disks are not
is not in position. stuck and can be moved by
hand.
Verify the Opto sensor is in
the correct position.
36 EG_NEXT_MIX Error during moving PM Interrupted task.
the next sample to Check other tasks in error
mix position in the details or repeat the
AutoSampler. process.
Check AS state window.

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Task Task ID Description Rated Troubleshooting

Code (PMC) Information and Options
37 EG_NEXT_PIERCE Error during moving PM Interrupted task.
the sample to pierce Check other tasks in error
position in the details or repeat the
AutoSampler. process.
Check AS state window.
38 EG_INIT_PORT Error during port Init C During normal operation
(HGB back light cannot be displayed.
missing). Development error.
39 EG_INIT_FPGA FPGA ERROR. C During normal operation
If this error occurs, no cannot be displayed.
error message Development error.
displays as the
communication fails.
40 EG_INIT_PIC Error during PIC Init C During normal operation
or upgrade (TCU or cannot be displayed.
LASER). Development error.
43 EG_SAMPLER_DELEG Error in AutoSampler MC During normal operation
main working cannot be displayed.
function. Development error.
44 EG_MOVING_DELEG Error in main moving MC During normal operation
function. (This cannot be displayed.
should not occur as Development error.
specific errors are
handled one by
one.)
45 EG_NMOVING_ Error in main non- MC During normal operation
DELEG moving function. cannot be displayed
(This should not Development error.
occur as specific
errors are handled
one by one.)

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Error Codes ADVIA 560 Hematology System

Task Task ID Description Rated Troubleshooting

Code (PMC) Information and Options
46 EG_COMM_PARAM NO communication C Contact technical support.
between HLS and Technical support may
LLS. request or perform this
action to resolve the issue:
• Check
communications:
1. Select Service > SW
upgrade.
2. Select Refresh data.
49 EG_FILE_NOT_FOUN File not found. Can C Contact technical support.
D occur when opening Technical support may
files. request or perform this
action to resolve the issue:
• Check
communications:
1. Select Service > SW
upgrade.
2. Select Refresh data.
50 EG_FILE_NO_INFOR File information read C During normal operation
MAT ION error. Can occur cannot be displayed.
when opening files. Development error
51 EG_FILE_OPEN Error opening a file. C Contact technical support.
Technical support may
request or perform this
action to resolve the issue:
• Check
communications:
1. Select Service > SW
upgrade.
2. Select Refresh data.

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ADVIA 560 Hematology System Error Codes

Task Task ID Description Rated Troubleshooting

Code (PMC) Information and Options
52 EG_GET_FILE LLS file cannot be C Contact technical support.
loaded (Can occur Technical support may
during upgrade). request or perform this
action to resolve the issue:
• Check
communications:
1. Select Service > SW
upgrade.
2. Select Refresh data.
53 EG_SEND_FILE LLS cannot be sent C Contact technical support.
during LLS upgrade. Technical support may
request or perform this
action to resolve the issue:
• Check
communications:
1. Select Service > SW
upgrade.
2. Select Refresh data.
54 EG_CRC_CREATE Cannot write the C During normal operation
CRC file to the SD cannot be displayed
card. Development error.
57 EG_ANSWER Cannot load C During normal operation
response packet into cannot be displayed
the communication Development error.
queue.
59 EG_DRAIN Error occurred while P Interrupted task.
Draining reservoirs. Check other tasks in error
Possible clogging or details or repeat the
pickup tubes were process.
not removed.

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Error Codes ADVIA 560 Hematology System

Task Task ID Description Rated Troubleshooting

Code (PMC) Information and Options
60 EG_NEEDLESETTING Error occurred M Can be caused by a
S during Needle mechanical error during
setting procedure. needle position
adjustment.
Perform a recovery.
Check needle position.
Technical support may
perform this action to
resolve the issue:
• Test XY and sample
rotor in Service testing
menu.
61 EG_HARDCLEANING Error occurred PMC Interrupted task.
during Hard Check other tasks in error
cleaning. details or repeat the
process.
62 EG_MAININIT Error occurred C During normal operation
during initialization. cannot be displayed
Development error.
67 EG_PRESSURE Error occurred P Perform a self test:
during measurement 1. In Diagnostics, select
or Init process. Self Test.
Possible pressure
2. Select Pneumatic tests.
sensor offset
problem or valves 3. Select Start both.
not working 4. When the self test
correctly. Timeout completes, check the
problem during Pressures area for
chamber draining. Passed or Failed.
5. Contact technical
support.
71 EG_DELETE_FILE Cannot delete file. C Cannot delete the selected
file. Database may be
damaged.
Check database to ensure
that all the measurements
are saved correctly.

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Task Task ID Description Rated Troubleshooting

Code (PMC) Information and Options
72 EG_SETTINGS Cannot save C The settings cannot be
settings. saved because of an
unknown error.
Select Save again.
Restart the analyzer
software.
75 EG_SAMPLER_INIT Error occurred C Check the AS state window
during Sampler Init. for error messages.
AutoSampler cannot In the AS state window,
reset. Mechanical select Reset.
misalignment on the
feeder disks or the
latch.
83 EG_SAMPLER_ Error occurred while C During sampler
WAITSTATE sampler was in wait measurement, one of the
state. samples has to wait until
the previous sample
measurement is finished.
An error occurred during
the measurement.
Check the AS state window
for error details.
99 EG_SAMPLER_CMD AutoSampler C The AutoSampler did not
communication is receive the command.
not working. Disconnect and reconnect
the AutoSampler.
Repeat the command.
Power off and power on the
AutoSampler.
102 EG_AUTOSAMPLER_ Error occurred C An error occurred during
MEASURE during AutoSampler the measurement.
measurement. Check the AS state window
for error details.

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Error Codes ADVIA 560 Hematology System

Task Task ID Description Rated Troubleshooting

Code (PMC) Information and Options
103 EG_FILL An error occurred PMC Run recovery.
during Filling the Check tubing.
system. A possible
Perform a self test:
clogging or pressure
sensor issue. 1. Select Diagnostics >
Self Test.
Possible mechanical
failure. 2. Select Pneumatic tests.
3. Select Start both.
4. When the self test
completes, check the
Pressures area for
Passed or Failed.
5. If pressure area failed,
contact technical
support.
105 EG_MOVE_DILUTOR_ An error occurred M Restart the analyzer.
1 during Dilutor 1. If error persists, perform a
Opto sensor or stuck self test.
piston.
1. Select Diagnostics >
Self Test.
2. Select Pneumatic tests.
3. Select Start both.
4. When the self test
completes, check the
Pressures area for
Passed or Failed.
5. If pressure area failed,
contact technical
support.

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Task Task ID Description Rated Troubleshooting

Code (PMC) Information and Options
106 EG_MOVE_DILUTOR_ Error occurred M Restart the analyzer.
2 during Dilutor 2. If error persists, perform a
Opto sensor or stuck self test.
piston.
1. Select Diagnostics >
Self Test.
2. Select Pneumatic tests.
3. Select Start both.
4. When the self test
completes, check the
Pressures area for
Passed or Failed.
5. If pressure area failed,
contact technical
support.
107 EG_MOVE_DILUTOR_ Error occurred M Restart analyzer.
3 during Dilutor 3. If error persists, perform a
Opto sensor or stuck self test:
piston.
1. Select Diagnostics >
Self Test.
2. Select Pneumatic tests.
3. Select Start both.
4. When the self test
completes, check the
Pressures area for
Passed or Failed.
5. If pressure area failed,
contact technical
support.

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Error Codes ADVIA 560 Hematology System

Task Task ID Description Rated Troubleshooting

Code (PMC) Information and Options
108 EG_MOVE_DILUTOR_ Error occurred M Restart analyzer.
4 during Dilutor 4. If error persists, perform a
Opto sensor or stuck self test:
piston.
1. Select Diagnostics >
Self Test.
2. Select Pneumatic tests.
3. Select Start both.
4. When the self test
completes, check the
Pressures area for
Passed or Failed.
5. If pressure area failed,
contact technical
support.
109 EG_BOB Error occurred M Check the sample rotor to
during Sample rotor ensure that the sample rotor
movement. Motor or is not hitting the front
micro switch failure cover.
because of an Check the micro switch.
overflow. PPB 1 is
not controlling the
sample rotor.
Process name in the
pneumatic error
details can indicate
that the problem
appeared during
turning the sample
rotor in or out.
110 EG_HORIZONTAL Error occurred M Restart the analyzer.
during Needle
horizontal
movement. Opto
flag misalignment
or greasing problem.

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ADVIA 560 Hematology System Error Codes

Task Task ID Description Rated Troubleshooting

Code (PMC) Information and Options
111 EG_VERTICAL Error occurred M Verify the sample tube is
during Needle correctly placed in the
vertical movement. sample adapter.
Washing head is not
set correctly or
needle height is not
correct.
Possible problem
during tube piercing.
112 EG_DILUFULL Cannot fill dilutor. M Repeat the diluter process.
(Dilutor may be
stuck).
113 EG_GET_BUBBLE Error when PM Interrupted task.
aspirating air for RBC Check other tasks in error
or WBC. (Dilutor may details or repeat the
be stuck.) process.
114 EG_BUBBLING Error bubbling RBC PM Interrupted task.
or WBC (dilutor may Check other tasks in error
be stuck). details or repeat the
process.
116 EG_MEAPUFF Error occurred P Perform a self test:
during 1. In Diagnostics, select
Measurement. Self Test.
Possible pressure
2. Select Pneumatic tests.
sensor related error,
leaking, or bad 3. Select Start both.
valve. 4. When the self test
completes, check the
Pressures area for
Passed or Failed.
5. Contact technical
support.
Technical support may
request or perform these
actions to resolve the issue:
• Check waste tube for
clogs.
• Check tubing valve 3,
valves 4, and 5.

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Error Codes ADVIA 560 Hematology System

Task Task ID Description Rated Troubleshooting

Code (PMC) Information and Options
117 EG_MEAPUFFBIG Error occurred P Perform a self test:
during Measurement 1. In Diagnostics, select
in glass reservoir. Self Test.
Possible pressure
2. Select Pneumatic tests.
sensor related error,
leaking or bad valve. 3. Select Start both.
4. When the self test
completes, check the
Pressures area for
Passed or Failed.
5. Contact technical
support.
Technical support may
request or perform these
actions to resolve the issue:
• Check waste tube for
clogs.
• Check tubing valve 3,
valves 4, and 5.
118 EG_MEAPUFFSMALL Error occurred P Perform a self test:
during Measurement 1. Select Diagnostics >
in Vacuum reservoir. Self Test.
Possible pressure
2. Select Pneumatic tests.
sensor related error,
leaking, or bad 3. Select Start both.
valve. 4. When the self test
completes, check the
Pressures area for
Passed or Failed.
5. If pressure area failed,
contact technical
support.
If the self test passes,
perform these tasks to
resolve the issue:
• Check tubing valve 23,
then valves 34 and 35.
• Check waste tube for
clogs.

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ADVIA 560 Hematology System Error Codes

Task Task ID Description Rated Troubleshooting

Code (PMC) Information and Options
121 EG_SAMPLE_MOVE Error occurred M Check the AS state window
during Sample for error details.
movement in Contact technical support.
AutoSampler.
122 EG_NEEDLE_ Error occurred PC Interrupted task.
WASHING during Needle Check other tasks in error
washing. details or repeat the
process.
124 EG_MIX_SAMPLE Error occurred PM Interrupted task.
during Mixing the Check other tasks in error
sample in details or repeat the
AutoSampler. process.
125 EG_CHAMBER_MIX Error during MIX PM Interrupted task.
chamber fill or wash. Check other tasks in error
details or repeat the
process.
126 EG_CHAMBER_RBC Error during RBC PM Interrupted task.
chamber fill or mix. Check other tasks in error
details or repeat the
process.
127 EG_CHAMBER_WBC Error during WBC fill PM Interrupted task.
or mix. Check other tasks in error
details or repeat the
process.
130 EG_BASO_SAMPLE Error during moving P Interrupted task.
sample from WBC Check other tasks in error
chamber to laser. details or repeat the
process.
137 EG_SET_POSITION Cannot set dilutor M Test or move dilutors in the
position. Service Testing menu.
Repeat the process.

11316937 Rev. 01 167 / 202

Error Codes ADVIA 560 Hematology System

Task Task ID Description Rated Troubleshooting

Code (PMC) Information and Options
140 EG_TIMEOUT Error occurred P Perform a self test:
during 1. Select Diagnostics >
Measurement. Self Test.
Chambers are not
2. Contact technical
draining in time.
support.
Chamber related
Technical support may
error (valve 9, 10,
request or perform these
11, 14, 15).
actions to resolve the issue:
• Check tubing.
• Drain chambers one-
by-one. (Select
Maintenance >
Check/clean draining
cones.)
• Change the related
valves.
149 EG_PRIME_DILU Error occurred PC Check diluent container and
during priming reservoirs.
diluent. Check diluent reservoir
valves.
150 EG_PRIME_SHEATH Error occurred PC Check diluent container and
during priming reservoirs.
sheath. Check diluent reservoir
valves.
151 EG_PRIME_LYSE Error occurred PC Check lyse container and
during priming lyse. reservoirs.
Check lyse reservoir valves.
152 EG_PRIME_STOPPER Error occurred PC Check diff 5 p container and
during priming reservoirs.
diff 5 p. Check diff 5 p reservoir
valves.
153 EG_AS_ERROR Error occurred MC Reset the AutoSampler.
during AutoSampler Check AS state window for
movement, Rack details.
movement failure or
cover is opened.

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ADVIA 560 Hematology System Error Codes

Task Task ID Description Rated Troubleshooting

Code (PMC) Information and Options
154 EG_RINSE Error occurred P Interrupted task.
during Rinsing. Check other tasks in error
details or repeat the
process.
155 EG_PNEU_INIT_2 Error in pneuinit 2. PC Interrupted task.
(Pneumatic Unit 2) Check other tasks in error
details or repeat the
process.
157 EG_WAKEUP Error occurred PMC Check tubing.
during Wakeup. Perform a self test:
Chamber draining,
1. In Diagnostics, select
pressure sensor or
Self Test.
dilutor movement
problem. 2. Select Pneumatic tests.
3. Select Start both.
4. When the self test
completes, check the
Pressures area for
Passed or Failed.
5. Contact technical
support.
158 EG_STANDBY Error occurred PMC Perform a self test:
during Standby 1. In Diagnostics, select
process. Chamber Self Test.
draining, pressure
2. Select Pneumatic tests.
sensor or dilutor
movement problem. 3. Select Start both.
4. When the self test
completes, check the
Pressures area for
Passed or Failed.
5. Contact technical
support.
Technical support may
request or perform this
action to resolve the issue:
• Check tubing.

11316937 Rev. 01 169 / 202

Error Codes ADVIA 560 Hematology System

Task Task ID Description Rated Troubleshooting

Code (PMC) Information and Options
160 EG_SELFTEST Error occurred PC Interrupted task.
during self test. Check other tasks in error
details or repeat the
process.
Retry the self test:
1. Select Diagnostics >
Self Test.
165 EG_SV_CLEAN Error occurred PMC Check shear valve assembly
during Shear valve and opto sensors
cleaning. Opto Check shear valve
sensor problem or movement.
disk is not replaced
correctly.
166 EG_AUTOSAMPLER Error occurred MC Interrupted task.
during AutoSampler Check other tasks in error
movement. details or repeat the
process.
167 EG_EXTRA1 Extra 1 task was C Interrupted task.
running during the Check other tasks in error
interruption. details or repeat the
process.
168 EG_EXTRA2 Extra 2 task was C Interrupted task.
running during the Check other tasks in error
interruption. details or repeat the
process.
169 EG_EXTRA3 Extra 3 task was C Interrupted task.
running during the Check other tasks in error
interruption. details or repeat the
process.
170 EG_SELFTEST Error occurred PMC Interrupted task.
during Self Test. Check other tasks in error
details or repeat the
process.

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Task Task ID Description Rated Troubleshooting

Code (PMC) Information and Options
171 EG_CHAMBERS Chamber drain times P Perform a self test:
are higher than the 1. In Diagnostics, select
predefined value – Self Test.
partial clogging.
2. Select Pneumatic tests.
3. Select Start both.
4. When the self test
completes, check the
Pressures area for
Passed or Failed.
5. Contact technical
support.
Technical support may
request or perform these
actions to resolve the issue:
• Drain chambers one-
by-one. (Select
Maintenance >
Check/clean draining
cones.)
• Check/clean draining
cones.
• Change the related
valves.
172 EG_CELL_CLOGGING Flow cell clogging. P 1. On the Maintenance
screen, select Flow cell
cleaning.
2. Turn on valve 1 and 20
or 1 and 32 for flow
checking.
173 EG_FILL_LASER Flow cell clogging. P This error displays when
recovery failed from
previous error.
Check the error details.
175 EG_REPAIR Error occurred C This error displays when the
during Recovery recovery failed from
from previous error. previous error.
Check the error details.

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Error Codes ADVIA 560 Hematology System

Task Task ID Description Rated Troubleshooting

Code (PMC) Information and Options
178 EG_PIC_ERROR TCU/Laser PIC C During normal operation,
firmware upgrade. cannot be displayed.
Development error.
179 EG_SET_OFFSET Error occurred C Contact technical support.
during Offsetting the Technical support may
system. This error request or perform this
can occur when action to resolve the issue:
reading and setting
1. If error occurred during
offsets together.
amplifier offsetting, in
Service > Adjustments,
select Read data.
2. Select Stop data.
3. Repeat the offsetting.
181 EG_REAGENT_LOCK Error occurred C 1. Contact technical
during Init or support immediately.
measurement. 2. Record the analyzer’s
Reagent lock OEM, software version,
module is not correct and the 4- or 6-digit
(wrong product, code on the reagent
OEM damaged or lock module connected
missing.) to LSDACQ board.
192 EG_SERIALS Cannot get LSDACQ C Contact technical support.
serial number. Technical support may
request or perform this
action to resolve the issue:
• Repeat the process.
• In Service >
Adjustments enter the
serial number and
select set serial.
193 EG_OFFLINERINSING Error during offline PM Check all reagent
rinsing. containers.
194 EG_DC NO laser DC level. C Contact technical support

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ADVIA 560 Hematology System Error Codes

Task Task ID Description Rated Troubleshooting

Code (PMC) Information and Options
195 EG_CLEANCELL Flow cell cleaning P Verify the laser is not
error occurred. clogged.
Perform a self test:
1. Select Diagnostics >
Self Test.
Repeat the Flow Cell
cleaning process.
196 EG_CLEANDILU Error during PM Interrupted task.
bleaching. Check other tasks in error
details or repeat the
process.
199 EG_CHECK_ALTITUD If the analyzer is P NOTE: Analyzer cannot
E operated above the operate above 3000 m
recommended (9842 feet). See Chapter
specifications, the F, Environmental Factors.
vacuum does not Check the waste tube on
perform at capacity valve 5.
or maximum level.
Replace valve 5.
Perform a self test:
1. In Diagnostics, select
Self Test.
2. Select Pneumatic tests.
3. Select Start both.
4. When the self test
completes, check the
Pressures area for
Passed or Failed.
5. Contact technical
support.

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Error Codes ADVIA 560 Hematology System

Task Task ID Description Rated Troubleshooting

Code (PMC) Information and Options
200 EG_RELEASE_AIR The status of any P NOTE: Analyzer cannot
valve cannot be operate above 3000 m
changed. There may (9842 feet). See Chapter F,
be salt build up in Environmental Factors.
the valve. Check the waste tube on
valve 5.
Replace valve 5.
Perform a self test.
1. Select Self Test.
2. Select Pneumatic tests.
3. Select Start both.
4. When the self test
completes, check the
Pressures area for
Passed or Failed.
5. Contact technical
support.
201 EG_AS_COVER AutoSampler cover is C Verify the AutoSampler
open. cover is closed properly.
202 EG_BLOODSENSOR Blood sensor C Check blood sensor tube.
malfunction.
203 EG_BLOODSENSOR_ Blood sensor C Check blood sensor tube.
CA LIB calibration failed.
205 EG_PRESSURE_OFFS Error occurred P Offset results are too high.
ET during Pressure Contact technical support.
sensor offsetting. Technical support may
perform this action to
resolve the issue:
• Replace the pressure
sensor.

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ADVIA 560 Hematology System Error Codes

Task Task ID Description Rated Troubleshooting

Code (PMC) Information and Options
207 EG_DRAIN_TCU Error occurred P Verify TCU inlet tubes are
during TCU draining. disconnected during
Possible vacuum draining.
problem. Pump or Fill and drain the TCU again.
clogging.
Perform a self test.
1. Select Self Test.
2. Select Pneumatic tests.
3. Select Start both.
4. When the self test
completes, check the
Pressures area for
Passed or Failed.
5. Contact technical
support.
208 EG_FILL_TCU Error occurred P Perform a self test.
during TCU filling. 1. Select Self Test.
Possible vacuum
2. Select Pneumatic tests.
problem. Pump, bad
valve, or clogging. 3. Select Start both.
4. When the self test
completes, check the
Pressures area for
Passed or Failed.
5. Contact technical
support.
Technical support may
request or perform this
action to resolve the issue:
• Verify all TCU tubes are
connected correctly.
See the specifications
for TCU tube
installation in the
ADVIA 560 Service
guide.

11316937 Rev. 01 175 / 202

Error Codes ADVIA 560 Hematology System

Task Task ID Description Rated Troubleshooting

Code (PMC) Information and Options
209 EG_DRAIN_FLOW_ Error occurred P Perform a self test.
CELL during Flow cell 1. Select Self Test.
draining. Possible
2. Select Pneumatic tests.
clogging or
valve 1, 20, 32 issue. 3. Select Start both.
4. When the self test
completes, check the
Pressures area for
Passed or Failed.
5. Contact technical
support.
On the Maintenance screen,
select Flow cell cleaning.
• Turn on valve 1 and
20 or 1 and 32 for flow
checking.
Clean the laser with syringe.
Check valve 1.
210 EG_FILL_FLOW_CELL Error occurred P On the Maintenance screen,
during Flow cell select Flow cell cleaning.
filling. Possible Turn on valve 1 and 20 or
clogging. 1 and 32 for flow checking.
Clean the laser with syringe.
Check valve 1.
211 EG_XY Error occurred M Contact technical support.
during Needle Check needle movement.
movement.
212 EG_EMPTY Error occurred P In the Maintenance screen,
RCHAMBER during Emptying RBC select Empty RBC
chamber. chamber.
Cone is clogged or Clean the draining cone on
valve 10 is not RBC chamber.
working correctly.

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ADVIA 560 Hematology System Error Codes

Task Task ID Description Rated Troubleshooting

Code (PMC) Information and Options
213 EG_EMPTY Error occurred P On the Maintenance screen,
WCHAMBER during Emptying select Empty WBC
WBC chamber. Chamber.
Cone is clogged or Clean the draining cone on
valve 11 is not the WBC chamber.
working correctly. Contact technical support.
220 EG_I2C_ERROR The internal C Communication error. The
communication I2C communication line is
inside the LSDACQ is not working.
down. Contact technical support.

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Error Codes ADVIA 560 Hematology System

178 / 202 11316937 Rev. 01

Appendix F: Specifications

Item Specification
H 520 mm 20 1/2 inches
System only W 410 mm 16 1/8 inches
Dimensions
D 493 mm 19 3/8 inches
System with Auto- H 520 mm 20 1/2 inches
loader W 671 mm 26 3/8 inches
D 493 mm 19 3/8 inches
Weight System only 36 kg 79.4 pounds
System with Auto-loader 46.7 kg 103 pounds
Sample Volume Closed and open vial mode 110 μL
Sample Type Human whole blood (K2- or K3-EDTA anticoagulant)
Tube Identification • By means of a keyboard (enter ID)
• By means of the barcode labels (manual and/or auto-
loader)
Sampling method Ceramic shear valve with 3 separate primary loops
Measured CBC+5-DIFF mode (26 parameters):
parameters
WBC, LYM, MON, NEU, EOS, BAS, LYM%, MON%, NEU%,
EOS%, BAS%, RBC, HCT, MCV, RDWsd, RDWcv, HGB, MCH,
MCHC, PLT, MPV, PCT, PDWsd, PDWcv, PLCC, PLCR
Throughput 60 tests/hour
Measurement • Volumetric impedance change for WBC, RBC, PLT
method
• Light scattering BASO measurement
• Light scattering 4-diff measurement LYM, MON, NEU,
EOS
• Spectrophotometry for HGB
Aperture diameter WBC 80 μm, RBC/PLT 70 μm
HGB measurement • Light source green LED with 568 nm wavelength
• Detector light to frequency converter

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Specifications ADVIA 560 Hematology System

Item Specification
Optical • Light source semiconductor laser diode with
measurement 650 nm wavelength and an output of 7 mW.
• Beam divergence ~1.5°
• Class 1 Laser Product (Class IIIB laser module if the
protective housing is opened, and interlocks are
defeated)
• Quartz flowcell with hydro-dynamic focusing
• Detector fiber optic coupled PIN Si photodiodes
• Internal safety interlock
Auto-alignment Horizontal calibration of laser beam position
system
Fine calibration with 5 μm polystyrene microsphere
calibration material
Reagents • ADVIA 360/560 Dil (20 liter) REF/SMN is 11170845
• ADVIA 560 Lyse 5L (5 liter) – with reagent lock key for
900 runs REF/SMN is 11170846
• ADVIA 560 5P Diff (1 liter) REF/SMN is 11170847
• ADVIA 360/560 Hypoclean CC (100 mL) – For hard
cleaning
See Chapter 6, Reagent Lock and Hardware Key (HK)
section for details.
Dilution ratios • WBC/BAS dilution – 1:170
• RBC/PLT dilution – 1:21,250
• 4 Diff dilution – 1:50
Sheath fluid Diluent
Control material ADVIA 560 Control Set (L-N-H), REF/SMN is 11170854
Calibrator • ADVIA 360/560 Calibrator 3.0 mL REF/SMN is
11170852
Quality Control QC diagrams, QC database
Flagging • Pathological (diagnostic) flags
• Lab limits (normal ranges)
• Reagents alert (3 measurement pre-alert-online
reagent replacement)
• Instrumental alerts, internal buffer for reagents
Calibration Manual and automatic modes supported
Software upgrade using a USB storage device
Data storage 100,000 records including flags, scatter- and histograms
capacity

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ADVIA 560 Hematology System Specifications

Item Specification
Data processing Intel Atom 1.6 GHz
Data store Windows 8 or XP Embedded
Display 800 x 600 color graphic LCD, portrait layout
External printing Using a USB port, any Windows 8 or XP compatible printer
External keyboard Via PS/2 or USB
Barcode Reader • Manual barcode reader via USB
• Built-in Barcode in the Auto-loader
Peripheral ports 4 x USB 2.0, Ethernet, PS/2
Power requirements • Power supply input 100–127VAC/200–240 VAC; 47Hz
to 63Hz
• Power Consumption maximum 400 VA (including
optional Auto-loader)
Main fuse F 10A H 250 V
Operating 15–30° C (59–86° F)
temperature
Maximum relative 80%
humidity
Minimum relative 10%
humidity

Environmental Factors
Operate the ADVIA 560 Hematology System within the ambient
temperature range of 15–30°C (59–86 °F) and a relative humidity range of
10% - 80%. The optimum operating temperature is 25°C (~77°F).
The ADVIA 560 Hematology System should be stored within the
temperature range of 5–35°C (41–95 °F). Avoid exposing the
ADVIA 560 Hematology System to direct sunlight or to extreme high or low
temperatures. If the ADVIA 560 Hematology System is subjected to
extreme temperatures during shipment or storage, the analyzer must be
placed for at least 1 hour in a room whose temperature is within the
operational range before installation or use.
Reagents should be stored at a temperature range of 15–30°C (59–86 °F).
Reagents may experience a temperature range of at most 5–35°C
(41–95 °F) for a maximum of 3 days.
Place the analyzer in a well-ventilated location.
Operation at an altitude above 3000 meters (9800 ft) is not recommended.
Transport temperature should be 5-40 °C (41-104 °F).

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Specifications ADVIA 560 Hematology System

Electrical Requirements
The analyzer should only be operated from a wall outlet meeting these
power input requirements:
• 100–127VAC/200–240VAC; 47Hz to 63Hz
• Power Consumption: maximum 400 VA
Please ensure that the wall outlet is also capable of supplying the power
consumption of any additional devices (such as a printer).
Use only the power cord supplied with the instrument. Avoid using
extension cords. The ADVIA 560 Hematology System comes with a power
cord appropriate for your power system. Proper use of the appropriate
power cord assures adequate grounding of the system. If the power is not
reliable, contact your representative for options such as the installation of
an external UPS module.

CAUTION
Failure to properly ground the ADVIA 560 Hematology System bypasses
important safety features and can result in an electrical hazard.

The instrument should not be placed near potentially interfering devices

capable of emitting radio frequencies (e.g. radio or television transmitters/
receivers, radars, centrifuges, X-ray devices, fans, etc.).
This analyzer is designed to be safe for transient voltages to INSTALLATION
CATEGORY II and POLLUTION DEGREE 2.

Space Requirements
Install the instrument in a suitable location. A poor location can adversely
affect its performance.
Select a well-ventilated location near a power source and close to a
suitable drain.
Place the unit on a clean, level surface. Leave at least 0.5 m (18 inches)
space on both sides and above the instrument to access pneumatics. A
minimum of 0.2 m (8 inches) must be maintained between the rear panel
and the wall to allow for heat dissipation and tubing clearance.
Ensure there is enough clearance in front of the
ADVIA 560 Hematology System to open the front panel. Allow enough
space if an optional external keyboard, mouse, or bar code reader will be
installed.

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ADVIA 560 Hematology System Specifications

The location should allow placement of the reagents in an unobtrusive

location below the laboratory bench where the instrument is placed.
Placement below the laboratory bench also enables storage of a spare set
of reagents. Never place the reagents above the
ADVIA 560 Hematology System.

CAUTION
Placing reagents above the ADVIA 560 Hematology System could result in
reagent overflow or spilling. Always put diluent tank on the floor, never
on the same level as the analyzer.

Weight Requirements
The ADVIA 560 Hematology System weighs 35 Kg (77 lb) without the
AutoSampler. The ADVIA 560 Hematology System with optional
AutoSampler weighs 47Kg (104 lb). Adding an external keyboard,
documents etc. can bring the total weight up to 60 Kg (132 lb). If you
decide to store the reagents on the same surface, then the combined
weight can reach 100 Kg (220 lb).
Select a table, laboratory shelf, or other location that can support the
weight of the ADVIA 560 Hematology System with accessories and is free
from vibration.

CAUTION
To allow reliable operation and to provide a safe work environment,
make sure that the table supporting the unit is stable enough to carry the
weight of the instrument and accessories.

Waste Disposal
The ADVIA 560 Hematology System waste contains human blood and
reagents that are chemically and biologically active, and should be
considered to be a potential infection and biohazard threat. Safe laboratory
practices must be followed including the use of personal protective when
operating the ADVIA 560 Hematology System and handling blood,
reagents, and waste.

BIOHAZARD
Biohazard System waste should be handled as a potentially biohazard
material. All applicable laws, regulations, and laboratory practices should
be followed in the handling and disposal of waste.

11316937 Rev. 01 183 / 202

Specifications ADVIA 560 Hematology System

Known Limitations
The ADVIA 560 Hematology System is not intended for analysis of animal
blood samples. Anti-coagulated and homogenized (well-mixed) human
blood samples must be free from contamination.
Blood samples must be analyzed within 7 hours of venipuncture.

Emergency Situations
Always follow all applicable laws and regulations with regard to emergency
situations.
If the ADVIA 560 Hematology System needs to be powered off due to an
emergency situation, such as fire or thunderstorms, follow the procedures
in Chapter 2, Emergency Shut Down.

ELECTRICAL HAZARD
In case of fire, do not use water to extinguish the fire unless the
ADVIA 560 Hematology System is disconnected from the electrical power
network.

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ADVIA 560 Hematology System Specifications

Performance Characteristics
Precision
System repeatability and reproducibility are defined as a standard
deviation (SD) or as a coefficient of variation (CV), whichever is greater.
Specifications are provided for primary and derived parameters only.
Normal Mode Normal Mode
Parameter Repeatability Reproducibility/ Units
Precision
SD CV% SD CV%
WBC < 0.18 < 2.7% < 0.20 < 3.4% 103/µL
NEU% < 3.50 < 3.50 %
LYM% < 3.10 < 3.10 %
MON% < 2.00 < 2.00 %
EOS% < 2.00 < 2.00 %
BAS% < 0.50 < 0.50 %
RBC < 0.11 < 1.7% < 0.13 < 2.0% 106/µL
HGB < 0.20 < 2.0% < 0.22 < 2.4% g/dL
MCV < 1.0 < 1.7% < 1.20 < 2.0% fL
RDWcv < 0.4 < 2.5% < 0.45 < 3.0% %
PLT < 23 < 6.0% < 27 < 7.0% 103/µL
MPV < 0.45 < 8.7% < 0.50 < 10.0% fL

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Specifications ADVIA 560 Hematology System

Accuracy
Normal Mode Criteria Evaluation
Parameter Levels Units
Absolute Percent Range Range
Low High
WBC 0.3 6.0% 0 100 103/µL
NEU% 3 10.0% 0 100 %
LYM% 3 10.0% 0 100 %
MON% 3 10.0% 0 40 %
EOS% 1.5 10.0% 0 30 %
BAS% 0.5 40.0% 0 5 %
RBC 0.15 6.0% 0 8 106/µL
HGB 0.3 6.0% 1 25 g/dL
MCV 1 6.0% 50 120 fL
RDWcv 0.5 6.0% 8 20 %
PLT 15 8.0% 0 2000 103/µL
MPV 0.8 10.0% 5 20 fL

Normal Mode Linearity

Parameter Coefficient of Nonlinearity Nonlinearity Linearity Linearity Units

Determination Absolute Relative Range Range
(R2) Error Error Low High
WBC > 0.95 00.80 < 3.0% 0.20 100.0 103/µL
RBC > 0.95 00.20 < 3.0% 0.36 7.190 106/µL
HGB > 0.95 < 0.27 < 3.0% 1.10 22.20 g/dL
PLT > 0.95 < 35.0 < 3.0% 15.00 1000 103/µL

Carry-over and Reportable Ranges

Parameter Allowable Carryover Units
3
WBC < 1.00% 10 /µL
RBC < 0.50% 106/µL
HGB < 0.80% g/dL
PLT < 1.00% 103/µL

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ADVIA 560 Hematology System Specifications

Sample Stability
Sample stability is characterized by the absolute and percent difference
from the baseline values measured after 30 minutes of venipuncture for
the parameters:
WBC NEU LYM EOS
RDW MON% HGB BAS%
RBC MON HCT BAS
PLT MCV EOS%
NEU% LYM%

For MPV, the baseline is 2 hours after venipuncture.

Either the absolute or percent difference must be under either the absolute
or the percent difference criteria indicated in the table in Accuracy in this
chapter. The maximum expected stability is 7 hours from venipuncture.

Mode to Mode Performance

Mode to mode performance specifies correlation between open versus
closed vial modes, and between close versus Autoloader modes.

Parameter n Correlation Intercept Slope Mean Units

Closed Open
Vial Vial
WBC 40 0.9997 -0.055 1.008 13.152 13.200 103/µL
NEU% 40 0.9954 -0.573 1.006 58.025 57.868 %
LYM% 40 0.9963 -0.025 1.004 30.696 30.661 %
MON% 40 0.9750 0.202 0.970 8.780 8.767 %
EOS% 39 0.8953 0.323 0.927 1.356 1.659 %
BAS% 40 0.6944 0.454 0.547 0.959 0.980 %
RBC 40 0.9989 -0.014 1.003 4.274 4.276 106/µL
HGB 40 0.9956 -0.105 1.016 12.104 12.191 g/dL
MCV 40 0.9957 -1.675 1.020 86.330 86.404 fL
RDWcv 39 0.9925 -0.212 1.015 16.263 16.327 %
PLT 39 0.9976 4.401 0.997 246.177 249.886 103/µL
MPV 40 0.9315 0.290 0.953 7.830 7.763 fL

11316937 Rev. 01 187 / 202

Specifications ADVIA 560 Hematology System

Reference Ranges
Parameter n Correlation Intercept Slope Mean Units
Closed Open
Vial Vial
WBC 40 0.9998 -0.050 1.015 13.152 13.055 103/µL
NEU% 40 0.9967 -0.391 1.006 58.025 57.794 %
LYM% 40 0.9957 0.104 1.013 30.696 30.263 %
MON% 40 0.9654 0.551 0.887 8.780 9.314 %
EOS% 39 0.9224 0.219 0.917 1.356 1.541 %
BAS% 40 0.7494 0.400 0.587 0.959 0.986 %
RBC 40 0.9989 -0.056 1.017 4.274 4.259 106/µL
HGB 40 0.9985 0.054 1.007 12.104 12.055 g/dL
MCV 40 0.9977 -0.489 1.006 86.330 86.410 fL
RDWcv 39 0.9923 -0.354 1.025 16.263 16.140 %
PLT 39 0.9963 4.795 0.997 246.177 245.949 103/µL
MPV 40 0.9236 0.330 0.947 7.830 7.880 fL

Evaluation of reference ranges for the ADVIA 560 Hematology System

system was conducted using a data set of 240 normal human whole blood
samples. Of the 240 samples, 120 were from female patients and 120
were from male patients > 22 years of age. Siemens recommends that
each laboratory establishes its own reference ranges.
Parameter Unit Lower Limit Upper Limit
WBC 103/µL 4.50 10.37
LYM % 14.76 45.40
MON % 2.91 12.1
NEU % 42.90 78.10
EOS % 0.10 7.00
BAS % 0.15 1.60
3
LYM 10 /µL 1.08 3.17
3
MON 10 /µL 0.20 0.91
3
NEU 10 /µL 2.43 7.42
EOS 103/µL 0.01 0.53
3
BAS 10 /µL 0.01 0.13
6
RBC 10 /µL 3.86 5.62
F-3.86 F-5.18
M-3.91 M-5.62

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ADVIA 560 Hematology System Specifications

Parameter Unit Lower Limit Upper Limit

HGB g/dL Normal 11.8 Normal 16.9
Female 11.8 Female 15.1
Male 12.0 Male 16.9
HCT % Normal 35.5 Normal 48.0
Female 35.5 Female 46.5
Male 36.2 Male 48.0
MCV fL 81.6 97.7
MCH pg 26.8 33.8
MCHC g/dL 31.1 35.5
RDWcv % 12.8 16.8
PLT 103/µL 151 361
3
PLCC 10 /µL 45 112
PLCR % 20.5 43.3
MPV fL 6.1 14.1

Background Limits in Normal Measurement Mode

Parameter Unit Blank High Limit

WBC 103/µL 0.20
HGB g/dL 1.0
RBC 106/µL 0.05
3
PLT 10 /µL 15

11316937 Rev. 01 189 / 202

Specifications ADVIA 560 Hematology System

Analytical Measurement Range

Parameter AMR Units
Low High
WBC 0.21 100.00 103/µL
NEU% 0.00 100.00 %
LYM% 0.00 100.00 %
MON% 0.00 100.00 %
EOS% 0.00 100.00 %
BAS% 0.00 010.00 %
NEU 0.00 100.00 103/µL
LYM 0.00 100.00 103/µL
MON 0.00 100.00 103/µL
EOS 0.00 100.00 103/µL
BAS 0.00 10.00 103/µL
RBC 0.36 07.19 106/µL
HGB 1.10 22.20 g/dL
HCT NA NA %
MCV 50 120 fL
MCH NA NA pg
MCHC NA NA g/dL
RDWcv 8 40 %
RDWsd 10 250 fL
PLT 16 1000 103/µL
MPV 4 30 fL

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ADVIA 560 Hematology System Specifications

Interfering Substances
The substances below can interfere with parameter measurement and
alternate measurement procedures may be required.

Parameter Interference
WBC > 5 NRBCs/100 WBCs, PLT clumps/large PLTs
RBC WBC Count > 75.0 x 103/µL
MCV WBC Count > 75.0 x 103/µL
PLT PLT clumps/large PLTs
Hemoglobin WBC count > 75.0 x 103/µL, Triglycerides > 280 mg/dL
Differential > 5 NRBCs/100 WBCs, PLT clumps/large PLTs

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Specifications ADVIA 560 Hematology System

192 / 202 11316937 Rev. 01

Appendix G: Parameter Calculations

Calculation Formulas
Parameter Description Units Calculation
3 9
WBC Leukocyte (white 10 /µL or 10 /L WBC = WBCCAL x WBCMEASURED
blood cells)
concentration
NEU Neutrophil 103/µL or 109/L Calculated from differential
LYM Lymphocyte percentage and WBC
MON Monocyte NEU = NEU% x WBC
Eosinophil LYM = LYM% x WBC
EOS
Basophil MON = MON% x WBC
BAS
concentration
EOS = EOS% x WBC
BAS = BAS% x WBC
NEU% Neutrophil Relative value are derived from
LYM% Lymphocyte % the optical 4 diff scatter
Monocyte populations
MON%
Eosinophil five-part
EOS%
differential
percentage
BAS% Basophil five part Relative value is calculated
differential % from the basophil optical
percentage scatter populations

RBC Erythrocyte (red 106/µL or 1012/L RBC = RBCCAL x RBCMEASURED

blood cells)
concentration
HGB Hemoglobin g/dL or g/L or Measured photometrically at a
concentration mmol/L wavelength of 568 nm; blank
measurement is performed per
cycle on diluent and lyse
mixture
HGB = HGBCAL x
(HGBMEASURED – HGBBLANK)
HCT Hematocrit % or absolute Calculated from RBC and MCV
HCTPERCENT = RBC x MCV / 10
HCTABS = HCTPERCENT x 100

11316937 Rev. 01 193 / 202

Parameter Calculations ADVIA 560 Hematology System

Parameter Description Units Calculation

MCV Mean Corpuscular fL Average volume of individual
Volume RBCs derived from the RBC
histogram
MCH Mean Corpuscular pg or fmol depends Average hemoglobin
Hemoglobin on HGB unit concentration of RBCs,
calculated from RBC and HGB
values.
MCH = HGB / RBC
MCHC Mean Corpuscular g/dL or g/L Calculated from HGB and
Hemoglobin HCTABSOLUTE
Concentration MCHC = HGB / HCTABSOLUTE
RDWcv Red Cell
Distribution Width %
cv (coefficient of
variation)

Derived from the distribution

width of the RBC histogram at
20% of peak
RDWCV = RDWCAL x
0.56 x (P2 – P1) / (P2 + P1)
A factor of 0.56 converts
measurement at 20% of peak
to 60% of peak.
RDWsd Red Cell Calculated from RDWcv and
Distribution Width fL the distribution width of the
sd (standard RBC histogram at 20% of peak
deviation) RDWsd = RDWcv x (P2 + P1) /
0.56
PLT Platelet 103/µL or 109/L PLT = PLTCAL x PLTMEASURED
(thrombocyte)
concentration
PCT Thrombocrit % or absolute Calculated from PLT and MPV
PCTPERCENT = PLT x MPV /
10.000
PCTABSOLUTE = PLTPERCENT /100

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ADVIA 560 Hematology System Parameter Calculations

Parameter Description Units Calculation

MPV Mean Platelet fL Average volume of individual
Volume platelets derived from the PLT
histogram.
PDWcv Platelet Distribution Derived from PLT histogram by
Width cv % PDWcv = RDWCAL x 0.56 x
(coefficient of (P2 – P1) / (P2 + P1)
variation) A factor of 0.56 converts
measurement at 20% of peak
to 60% of peak
PDWsd Platelet Distribution Calculated from PDWcv and
Width sd (standard fL the distribution width of the
deviation) platelet histogram at 20% of
peak PDWsd = PDWcv x
(P2 + P1) / 0.56
PLCC Large platelet 103/µL or 109/L PLT count above 12 fl in size
count *
PLCR Large platelet % PLCR = PLCC / PLT x 100
percentage *

11316937 Rev. 01 195 / 202

Parameter Calculations ADVIA 560 Hematology System

Parameter Display Ranges

Parameter Range Selectable
#WBC 0.00–120.00 * 103/µL or 109/L cells/µL, cells/L
#NEU 0.00–120.00 * 103/µL or 109/L cells/µL, cells/L
3 9
#LYM 0.00–120.00 * 10 /µL or 10 /L cells/µL, cells/L
#MON 0.00–120.00 * 103/µL or 109/L cells/µL, cells/L
#EOS 0.00–120.00 * 103/µL or 109/L cells/µL, cells/L
#BAS 0.00–120.00 * 103/µL or 109/L cells/µL, cells/L
#NEU% 0–100% Not selectable
#LYM% 0–100% Not selectable
#MON% 0–100% Not selectable
#EOS% 0–100% Not selectable
#BAS% 0–10% Not selectable
6 12
RBC 0.00–10.00 * 10 /µL or 10 /L cells/µL, cells/L
HGB 0–30 g/dL or 0–300 g/L or 0-20 g/dL, g/L, mmol/L
mmol/L
HCT 0–60% or 0.00–0.60 percentage or
absolute
MCV 0–250 fL Not selectable
MCH (no restrictions) pg or fmol depends on HGB unit
MCHC (no restrictions) g/dL or g/L or same as HGB unit
mmol/L
RDWsd (no restrictions) fL Not selectable
RDWcv (no restrictions)% Not selectable
3 9
PLT 0–1200 * 10 /µL or 10 /L cells/µL, cells/L
3 9
PLCC 0–2400 * 10 /µL or 10 /L cells/µL, cells/L
PLCR 0–100% Not selectable
PCT (no restrictions)% Not selectable
MPV 3.0–(no upper restriction) fL Not selectable
PDWsd (no restrictions) fL Not selectable
PDWcv (no restrictions)% Not selectable

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Appendix H: Installation

Your Siemens certified service engineer will perform the initial installation
of the ADVIA 560 Hematology System. The ADVIA 560 Hematology System
should only be operated by properly trained laboratory personnel.

ADVIA 560 Hematology System Package Contents

After opening the ADVIA 560 Hematology System packaging, you will find
an accessory box. The analyzer is in a plastic bag in between cushioning
protective material. After opening the bag, remove the desiccant packs.
The package should contain the following items:
• The ADVIA 560 Hematology System
• Accessories box containing:
○ Power cord
○ User Manual (this document)
○ Sample tube adapter (1 pc)
○ Reagent tube kit in a plastic bag, with 3 caps and 5 color-coded
tubing
○ Plastic waste container
○ Cardboard box for the waste container
○ Preparing for shipment tube kit (1 piece)
○ ADVIA 560 Hematology System final check report
Please inform your Siemens Representative if any item is missing or
damaged. Retain the original ADVIA 560 Hematology System packaging
for future transportation and storage.

Autoloader Package Contents

The Autoloader is an optional unit that attaches to the
ADVIA 560 Hematology System. If the optional Autoloader unit was
ordered, package should contain the following items:
• Autoloader unit
• Sample tray and 10 pieces of sample racks
• Autoloader final check report
Please inform your sales representative if any item is missing or damaged.
Retain the original Autoloader packaging for future transportation and
storage.
11316937 Rev. 01 197 / 202
Installation ADVIA 560 Hematology System

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Appendix I: Barcodes

11316937 Rev. 01 199 / 202

Barcodes ADVIA 560 Hematology System

200 / 202 11316937 Rev. 01

Appendix J: AutoSampler Error Codes

Sample positions on the AutoSampler information screen are shown

differently than in tray view. The tray view shows positions from A1 to J10
while on the AutoSampler information screen the same range is coded as
00-99. (Position 00 is A1, position 01 is A2…position 99 is J10).

AS Error Troubleshooting Action

Code
1 The cover has been Enure that the AS cover is in down position and the
opened! top green LED is green.
17 Undesired position The rack is jammed. Reset the sampler and repeat
reached: X mid! the same process without the racks.
20 Cannot move tray! The x opto sensor is damaged or misaligned. The
rack is not moving. Check X opto sensor LED under
the rack.
33 Cannot leave Unit cannot move the racks into the unit. Possible
position: Y home mechanical misalignment. Make sure that the Y
opto board is not misaligned, the opto sensors are
correct and that the opto flag is in home position.
39 Cannot reach desired The rack cannot go into the unit. Possible rack jam
Y position! or mechanical movement error. Repeat the same
process without the rack.
40 Cannot move rack! The rack is jammed. Reset the sampler and repeat
the same process without the racks.
50 Cannot reach K home Mixer problem. The mixer cannot go to home
position! position. Check that the home opto sensor LED is on
when opto sensor is triggered.
51 Cannot reach K end Mixer problem. The mixer cannot reach the end
position! position or the end opto is not working. Check end
opto LED when end opto is triggered. Bend the
mixer manually to reach the end position.
53 Cannot leave K end The end opto of the mixer is continuously sensing.
position! Possibility that the opto is damaged or there is dirt
on the sensor.
57 Mixing error! The mixer jammed during mixing after end opto is
reached. Check that the tube in the AS is supported
and there is no foreign material in the mixer.

11316937 Rev. 01 201 / 202

 AutoSampler Error Codes ADVIA 560 Hematology System

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202 / 202 11316937 Rev. 01