URIT-8021A

Automatic Biochemistry Analyzer

Operation Manual
NOTE:

1) Read this manual carefully before operating the analyzer.

first time.

2) Check the electrical requirements of the equipment before turning it on, and

properly connect the grounding wire.

3) Turn off the power of the analyzer and disconnect the electrical wire if

the device has been out of use for a long time.

Do not activate the analyzer if it is in an abnormal condition or

damaged.

5) There is potential biological risk from the reagents and samples; the

The operator must follow appropriate biosafety practices.

Discard the reagent and sample used according to regulations.

local and national.

II
 INDEX
Declaration and Warranty Term ..........................................................01
Prefácio ..................................................................................................05
Symbols ..............................................................................................05
Safety Regulations..........................................................05
Precautions ..........................................................................................07
Chapter 1– Instalação..........................................................................10
1.1 Desempacotamento....................................................................10
1.2 Installation....................................................................................10
1.2.1 Location Requirements
1.2.2 Requisitos de Alimentação.....................................................11
1.2.3 Device Connection ............................................................12
Chapter 2– Overview of the Apparatuso .14
2.1 Expected Use.................................................................14
2.2 Structure .....................................................................................14
2.3 Performance Specifications.................................................17
2.4 Standard Specifications................................................................18
Chapter 3– Principles of Measurement......................................................20
3.1 Principle ......................................................................................20
3.2 Measurement Methods...................................................................20
3.2.1 Measurement of the End Point .........................................................20
3.2.2 Measurement Point 2...............................................................21
3.2.3 Measurement Rate....................................................................22
Capítulo 4–Funcionamento.................................................................23
4.1 General Procedures.................................................................23
4.1.1 Ligand..................................................................................23
4.1.2 Creating the Standard Curve ........................................................23
4.1.3 Performing Quality Control Analysis....................23
4.1.4 Performing the analysis of Samples.........................................24
4.1.5 Turning Off.............................................................................24
4.2 Preparation for Analysis.............................................................24
4.2.1 Turning on the Device.........................................................24
4.2.2 Verification of items..............................................................25
4.2.3 Sample Preparation......................................................25
4.2.4 Preparation of Consumables................................................26
4.3 Analyses
4.3.1 Standard Analysis Record..................................................27
III
 4.3.2 CQ Analysis Record........................................................27
4.3.3 Routine Analysis Record..............................................27
4.3.4 Start of Analyses .................................................................29
4.3.5 STAT Analyses........................................................................29
4.3.6 End of Analyses....................................................................30
4.4 Processing the Test Result.......................................30
4.4.1 Patient Information Entry.....................................30
4.4.2 Modification of Test Result .......................................31
4.5 Review of Test Result...................................................31
4.6 Review of the Analytical Curve .........................................................32
4.7 Manutenção do Banco de Dados................................................32
4.7.1 Database Backup ..................................................32
4.7.2 Database Recovery.........................................32
Chapter 5– Software Configurations............................................33
5.1 Chemical Analysis Menu ...........................................................33
5.1.1 Configuration of test item parameters...................33
5.1.2 Configuration of other parameters.......................................35
5.1.3 Profile Configuration
5.1.4 Configuration of the Calculated Item..........................................36
5.1.5 Item Sequence Configuration......................................37
5.1.6 Quality Control Configuration................................37
5.1.7 CQ Data Processing ..........................................38
5.1.8 Display of the CQ Graph .........................................................38
5.2 Standard Menu and CQ .....................................................................38
5.2.1 Standard and CQ..........................................................................38
5.2.2 A/D Value.................................................................38
5.3 Laboratory Menu.............................................................39
5.3.1 Header and COM Configuration .......................................39
5.3.2 Configuration of hospital information............................39
5.3.3 Color chart configuration..............................................40
Chapter 6– Quality Control and Calibrationo ...............................41
6.1 General Information.....................................................................41
6.2 Use of Sample Control ............................................41
6.2.1 Sample Control Classification .................................41
6.2.2 Precautions in Handling Control Samples ..............41
6.2.3 Target Value Configuration, SD and Control Limit............42
6.2.4 CQ Procedure ..................................................................42
6.3 Quality Control Rules..........................................................43
6.4 How to Handle the Control Machine ...........................46
6.5 Calibration...................................................................................47
6.5.1 When to Calibrate.....................................................................48
6.5.2 How to Calibrate

IV
Capítulo 7–Manutenção ......................................................................50
7.1 Maintenance Procedures...................................................50
7.1.1 Cleaning of the probe and the stirring rod ...........................50
7.1.2 Washing of the Bucket......................................................51
7.1.3 Bucket Signal .....................................................................51
7.1.4 Device Parameter..........................................................52
7.2 Daily Maintenance......................................................................52
7.3 Weekly Maintenance .................................................................53
7.4 Monthly Maintenance....................................................................54
7.5 Maintenance of the Machinery in Disuse.........................................54
7.6 Preventive Maintenance ..............................................................55
Chapter 8– Problem Solvings .56
8.1 General Information
8.2 Troubleshooting Guide...................................................56
8.3 Requesting Technical Assistance...........................................................57
8.4 Problem Solving Table................................................57
Chapter 9– Storage and Transport .........................................66
9.1 Storage..........................................................................66
9.2 Transportation
Appendix A: Parts Replacement............................................................67

V
 Declaration and Warranty Term

Congratulations on becoming a user of MH Lab equipment. From now on you

you have in hand one of the most sophisticated machines in Brazil, which offers high precision and
reliability to your operator.

MH Lab is responsible for the review and explanation of this manual, maintaining the
relevant correct and updated content without isolated notification.

Some of the demonstration figures are for reference to the real object, even though
with some differences.

All the information included here is protected by copyright.

No part of this manual may be reproduced, stored, or transmitted from

any form or means. All instructions must be followed. Under no circumstances the MH
The lab shall be held responsible for failures, errors, and other deficiencies resulting from non-
compliance by the client with the procedures and precautions contained in this manual.

General warranty conditions

This warranty is valid only in Brazil.

General aspects
a) The warranty always starts on the day of billing of the equipment at MH Lab and
refers to all types of material and manufacturing damages that may arise during
the normal use of the equipment.
b) The warranty period is 01 (one) year from the date of invoicing.
present on the product invoice.
c) Carefully keep the original invoice, MH Lab and your authorized distributor.
reserve the right to reject a repair or warranty confirmation if that
document not to be presented.
d) If it is necessary to send us your equipment, make sure that it is

6
 conditioned in its original packaging or in a safe manner for transport. The
MH Lab does not take responsibility for other materials submitted that do not comply.
part of the original volume of the provided equipment.
e) We appreciate you sending us a description of the failure along with the equipment.
o mais detalhadamente possível e uma cópia da nota fiscal. Antes de nos enviar o
equipment, please contact our Customer Service,
through the phone (11) 5102-4433 or with one of our distributors.
f) This warranty is valid only for devices purchased through MH Lab or from
one of its authorized distributors.

Scope
In the event of any failure of the equipment covered by this warranty, MH Lab
ensures the repair or replacement of the same. In this sense, MH Lab may, at its
description, decide, taking into account the repair costs, alternatively, replace the
equipment for a new one, or for a repaired equipment of the same quality.

The warranty for consumable materials is not assumed, that is, parts that during use
normal parts of the device need to be replaced regularly, such as, for example, the
printer reagents and paper coils.

If it is proven during the repair that it is a fault not covered

due to warranty or misuse of the product, MH Lab will only proceed with the repair by charging a
same as the client, after approval of the budget prepared for this purpose.

Problems found in the electrical network that may cause equipment failures
should be resolved by the client and are not the responsibility of MH Lab. If the
the customer is not committed to solving the identified problem, the warranty will be terminated and
Damage caused to the equipment will be the responsibility of the customer.

Exclusion
MH Lab does not assume liability for failures and damages arising from influences.
external, accidental damage, improper use, as well as modifications, renovations,
expansions, use of parts from other manufacturers, negligence, transportation or
inadequate packaging.

7
 The warranty ceases if the equipment failure was caused during a
maintenance or repair carried out by personnel not belonging to MH Lab or the technical service

authorized by it for this equipment. The warranty also ceases if they have been
modified or damaged, making the warranty stickers illegible,
serial numbers of the equipment or an integral part thereof.

The use of reagents from brands not approved by MH Lab will lead to the end of
guarantee.

Customer service
Before sending the equipment to MH Lab, the customer must contact our central office.
customer service, where you will receive more information on how to use your
right of guarantee.

MH Lab additionally offers a free customer support hotline for inquiries.

and questions related to the product. This service will be available whenever the
responsible technicians are available at the time of the request, otherwise, the
the company will respond to the request as soon as possible.

For onsite repair or replacement, the customer must ensure, on their part, the
following points:

You must grant the MH Lab staff unlimited, secure, and immediate access to
equipment.

You must make available to the MH Lab staff all the reagents they need.
to correctly perform your task, for purposes of testing and diagnosis, as well as for
the elimination of errors, with the client bearing the costs.

You should take all other measures that MH Lab needs in order to execute.
your task correctly.

The customer is responsible for the configuration and connection of external devices, if

8
if there are, after having resorted to the MH Lab assistance service.

The minimum cancellation period free of charge for repair or replacement

The local time is 48 (forty-eight) hours. After this period, we will have to invoice the expenses.
that have been presented to us due to a delayed or not completed cancellation.

If, during the service, it is proven that it is a non-covered failure

under warranty, or due to misuse of the product, MH Lab will only proceed with the repair charging
the same as the client, after approval of the budget prepared for this purpose. In this
The budget will include the costs of the technician's travel from the headquarters to the location of the

service.

9
 Preface

This document is the operating manual for the URIT 8021A Automatic Analyzer.
Biochemistry. It describes the structure, operation, maintenance, and procedure for solution.
about the problems of the instrument in detail. Operators should read the manual carefully and
obtain special training before operating to ensure instrument accuracy,
normal operation and personal safety.

Symbols
The meanings of the signals used in the URIT-8021A are as follows:

Care. Please consult the

Care.
document
Electric Shock.
correspondent
Careful.
Biological Hazard
Hot surface
Grounding
Connected
Protector

Turn off In Vitro Diagnosis

Keep away from

Shelf life of protection
sources of heat and
environmental
radiation

Serial number Manufacturer

It can cause damage

Recycling
personal

Consult the Manual

of Operations

10
 Chapter 1 – Safety Guidelines

1.1Safety Precautions
Please comply with the following rules for safety and effective use.

Prevent Breakage and Fire

Please take the following precaution to prevent breakage.
CAUTION
The installation must comply with the installation instructions in the manual.
If the displacement is necessary, contact your distributor first.
local or the MH Lab.

Prevent Electric Shock

Please take the following precaution to prevent electric shock.
CAUTION
1) DO NOT move the screws on the cover, nor the screws on the back plates
the sides.
2) If there is a spill or a liquid comes into contact with the instrument,
please contact MH Lab. Neglecting the fluid can cause shock
electric.

Prevent Injury in Employees

Please take the following precautions to prevent injury.
CAUTION
1) While the instrument is in motion, DO NOT touch the moving parts.
like the suction probe and the mixer, etc. And DO NOT insert the finger or hand
in the open part of the instrument
2) Before changing the bulb, turn off the cooling switch and wait the
cool the lamp. Otherwise, you may burn yourself

Eye protection
Please take the following precaution to protect your eyes.
CAUTION
DO NOT look directly at the light emitted from the lamp source when the instrument
is in motion.
11
 Precision and Accuracy of Data
Please pay attention to the following issues to obtain accurate data.
CAUTION
1) DO NOT open the top cover, rear cover, and the reagent tray.
when the instrument is under the condition of analysis.
Please check the accuracy of the instrument by performing quality control.
before use.
Please follow the manual's guidelines to maintain, check, and replace the
set.
4) Please follow the corresponding explanation for handling the reagent.
quality control materials and reference materials.
5) Please handle the sample according to the requirements of the manual.

Chemical and Biological Safety

Please comply with the following questions for chemical and biological safety.
Biological Hazard
If the chemical substance adheres to the human body, contamination may occur. NO
touch the sample, in the mixed solution and in the residual solutions directly. Use
gloves and protective clothing or even safety goggles, if necessary. If the
sample splashing on the skin accidentally, please treat immediately according to
with the work regulations and consult a doctor.

CAUTION
Some reagents are strong acids or alkaline. Please use them carefully.
avoiding direct contact. If the reagent spills onto the human body,
immediately wash with water and soap. If the reagent splashes in the eyes
accidentally, wash with water and consult an ophthalmologist.

Handling of Residual Solution

Please comply with the following questions when handling the residual solution for
avoid personal injury and protect the environment.
Biological Hazard
Some substances contained in the QC solution, standard solution and solution
residuals are regulated by discharge standards and control norms
pollution, the waste must be disposed of according to protection regulations
relevant environmental.

12
Systematic Use
CAUTION
1) The Automatic Biochemistry Analyzer. URIT-8021A is intended for use by
medical institution and laboratory to analyze some chemical composition
specific to human body fluid. If the instrument will be used beyond
In this regard, first consult the MH Lab.
Please consider it together with the clinical symptom or another outcome of
analysis when making the clinical judgment.

Operational Environment
CARE
1) Please install the instrument according to the installation instructions.
specified in the manual. Otherwise, the results may not be
reliable and this can even cause system damage.
Please contact MH Lab if the system status changes.

Indication for System Use

CAREFUL
1) The operator must be trained before operating the instrument. Please follow
the manual instructions to operate it. Improper operation may cause
personal injury, damage to the system and inadequate result.
2) Please perform calibration and quality control tests before use.
system for the first time to ensure that it can be used normally.
3) A quality control test must be performed when using the system. In case
On the contrary, the reliability of the result will not be guaranteed.
4) The communication articulation of the analytical piece must connect with the
communication articulation of the operational piece. Please use the cables of the
MH Lab for the connection.
5) The operational piece is an external computer on which the software is installed.
specified operational. The computer must remain in use
exclusive to the instrument. DO NOT run any other software when
connected to the instrument. Misuse may result in
computer virus infection

13
1.2 Use Precautions
Precaution for Sample Handling
WARNING
The URIT 8021A can be used to process serum, urine, and sample of
cerebrospinal fluid. Some samples or reagents may not be
compatible with measurements on this device. In this case, please consult the
reagent suppliers.
The sample should not contain insoluble substances such as fibrin and powder.
Coagulation and impurities can block the aspiration probe, causing
such negative effects in exams.
Anticoagulants and preservatives contained in the sample may interfere with
accuracy of examination results.
4) Note the storage condition of the sample. The storage
inadequate can deteriorate the sample. For example, a serum sample
can be stored for 2 weeks at a temperature of -20℃, already at 22~24
°C, only 2 hours. After the expiration, the concentration of substances
contained in the serum will increase or decrease significantly, especially
enzymes such as ALT and AST.
5) If visible suspended substances exist in the urine or in samples
of cerebrospinal fluid, centrifuge the samples to remove the
substances suspended before the analyses.
6) If pretreatment is necessary for the samples, or if you want
centrifuge serum samples, please consult your supplier first
of reagent.
7) DO NOT expose samples to air for too long, as they may be
contaminated or evaporate and, therefore, test results may occur
erroneous.

14
Handling of Reagents, Reference Materials, and Control Serum

CAUTION

1) For storage, handling, and use of reagent, or selection of

reference materials and QC material, consult the Instructions for Use
provided by its manufacturer. Inadequate storage cannot
to guarantee the accuracy of the test results, even without having exceeded the
validity.
2) Please consult the reagent supplier for usage instructions.
reagent, of the standard solution and of the control serum.
3) The maintenance instructions for the reagent, standard solution and materials of
controls are marked on the packaging or included in the manual. A
Improper maintenance can cause incorrect results even within
of validity.
4) For the stability of the reagent in open environments, contact your
reagent supplier.
5) Make sure to perform calibration when replacing the reagent. If
On the contrary, the test result may be inaccurate.
6) Configure the reagent parameters provided by the manufacturer of the
reagent before the analyses. Only the proper configuration of the reagent
can guarantee correct exam results.

Cross-contamination between Reagents

CAUTION
Cross-contamination between reagents can influence the results.
of the tests. Contact your reagent supplier for more
details. As for the way to check for cross-contamination between the
reagents, please contact MH Lab.

Precaution in the Course that Analyzes

CAUTION
1) If the serum is hemolytic, icteric, or whitish (milky), the results
exams can be influenced. Please contact your supplier of
reagents for more details.
Distilled water must be free of bubbles.

15
 Beware of Electromagnetic Wave Interference
CAUTION
Keep the instrument away from strong noise sources and waves
electromagnetic. Turn off cell phones and transmitters-receivers.
operate the instrument, as electromagnetic waves can have effects
adverse in the instrument.

Other Care
CAUTION
1) Do not touch the keyboard, mouse, or trackpad when your hands are
wet, including chemistry.
2) Check if the samples have contaminations (dust or fibrin) and air bubbles
before analyses.
3) To perform periodic maintenance, examinations, and replacements according to the
manual to obtain the exact result.
4) To replace important parts, such as the lamp power supply,
suction probe, reaction bucket, etc., please consult MH Lab.
5) For configuration of sample volume, reagent volume,
wavelength, standard values, etc., please refer to the instructions on
reagent kit as well as this operating manual. Check the quality
of distilled water and detergent, check the calibration results of
check, control results, and sample results after the analyses.
Make sure there are no air bubbles in the flow paths.

1.3 Installation
CAUTION
Only the technician from MH Lab can carry out the installation of the URIT-8021A.

Only the technician from MH Lab can execute the installation of the URIT-8021A, users
They must make preparations to meet the installation requirements according to this.
manual before installation. If displacement is necessary, please contact your
local distributor or MH Lab.

1.3.1 Inspection of the Instrument

Please check the packaging according to the following procedures:

Carefully unwrap the packaging and remove the Automatic Analyzer from
URIT 8021A biochemistry and its accessories.
16
2. Inspect the device and accessories for quantity and visible signs of damage.
according to the Packing List that accompanies it.

3. If there is any loss or damage, please contact the distributor or manufacturer.

immediately.

1.3.2 Installation
The device is highly sophisticated, so proper installation is very important.
important for your performance. The operator must ensure that the environment and conditions
Electricals comply with the recommended conditions. Provide a distance of 50cm by the
less on each side for operation and maintenance.

1.3.3 Requisitos de Ambiente

Keep away from direct sunlight
Dust book
Installed on horizontal floor
Load capacity on the floor: 250kg
Temperatura ambiente: 10℃~35℃
Relative Humidity ≤85% (No condensation)
Atmospheric Pressure 86kPa106kPa
The reliability of the data will not be guaranteed if the temperature and humidity variation
I would exceed the specific limit.
Good ventilation, not facing the air conditioning
No apparent vibration
Keep away from electromagnetic fields and electrical switch
The instrument must be close to the power supply.

1.3.4 Location Requirements

The installation layout of the instrument is below. The distance around is the space.
recommended for maintenance.

17
 Figure 1-1

Measurement: cm

Instrument dimensions: 102cm × 83cm × 112cm (L × W × H)

Operation Plate Dimensions (For reference only): 70cm×50cm×80cm (C×L×H)

1.3.5 Requisitos de Energia

The following power supply must be prepared; the control panel must be
located within 10m.

Energy
Voltage 230V~, 50/60Hz

Grounding
Adapt to local energy needs, using a three-pin plug.

Power outlet
A 15A power strip with more than three 5A outlets. High power devices
power should not share the board with the instrument, such as refrigerator, air
conditioned, etc.

Cable CAT3 must be used; the type of wire and socket depend on voltage.

18
 CAUTION
Ensure that the instrument is properly grounded.
poor grounding can bring negative effects on the test result and
even damage to the instrument.

1.3.6 Instrument Connection

1 Remove the power cord, insert one end into the instrument's power interface, and turn it on.
the other end in the force.

2 Use the communication line provided by MH Lab to connect. One end

connected to the computer's COM serial port; the other end connects to the serial port
WITH the instrument. And please tighten the screws.

Distilled water and detergent are necessary for the analyses, while the solution of
residue discharges. There are inductive liquid level interfaces at the back of the instrument
to connect to the distilled water drum, detergent drum, and waste drum.
Connect one end of the tube and the inductive liquid level line to the instrument, connect
the other end to the corresponding drum. For the connection of the instrument, please see the
figure 1.3.6.

Figure 1-2

Detergente–Água destilada–Sol. de Descarte

19
 CAUTION
Please connect the flow path tubes according to the engineer's instructions.
of services from MH Lab or by employees authorized by them.

NOTE:
Do not place the instrument in a location that makes it difficult to operate the device.
of cutting.

20
 Chapter 2–Introduction to Equipment

2.1 Brief Introduction

The URIT 8021A is a clinical chemical instrument with open characteristics.
full automatic, advanced/optional, STAT priority and computer controlled.
URIT-8021A is intended for use in conjunction with reagents for quantitative measurement.
certain chemical items in serum, urine, and cerebrospinal fluid. Please read the manual of
Operate carefully before use, as this is a highly sophisticated instrument.

1) The URIT-8021A Work Unit consists of the optical unit, operation unit.
mecânica, unidade de controle do caminho do líquido, unidade de circuito de hardware
the operational unit.

2) The mechanical unit consists of a suction system, mixing system, and system
of washing eight probes for bucket. The vacuum system includes sample tray,
reagent tray, suction mechanism, syringe (the inner center of the syringe is
made of ceramic, which provides precise aspiration and requires no maintenance) and
a washing terminal for suction probes. The sample tray consists of
45 positions, with 35 routine positions, 5 standard positions, 3 QC positions, and 2
STAT positions. The test tube or sample cup can be positioned in
routine position. The reagent bottle in various specifications can be positioned
on the reagent tray. The optical unit includes 120 cuvettes, high-resolution filter, and light.
halogen. An optical unit is an optical system of spectrophotometry in conjunction with the sealer,
static, series and rear

3) The control unit for the passage of liquid consists of a pump.

vacuum, solenoid valve, syringe, flushing system, and piping system, etc.

4) The operational unit is an external computer (CPU 2.0 GHz or higher, drives
16X DVD, memory: 1GB or larger), the software application must be configured under the
Windows XP operating system.

5) The instrument is easy to operate. The screen menu layout is rational, the name is simple.
Contains items such as exam parameter settings, entry of information from
["patient","quality control","reagent","data research","standard","perform tests"]
and hardware parameter. After the setup, place the sample and the reagent in
instrument and begin the analysis. At the end, print the result using the external printer.

21
 2.2 Intended Use
The instrument is for professional use only in vitro in hospitals, clinics, and
laboratories.
CAUTION
Some samples may not be analyzed according to the parameter of
exam and reagent. In this case, please contact the manufacturer or distributor of the
reagent.

2.3 Main Structure

2.3.1 Performance and Composition

The analyzer mainly consists of an analytical unit, computer, and printer.
Computer and printer are optional accessories.

The analytical unit is composed of a reagent tray, a sample tray, tray

reaction mechanism, suction mechanism, mixing mechanism, optical system, system of
liquid path and hardware circuit.

O operador podia selecionar o compartimento de acordo com a necessidade.

22
 Figure 2-1

2.3.2 Superior Vision

Figure 2-2

23
 2.3.3 Rear View

Figure 2-3

2.3.4 Operation of the Main Part

1) Sample Tray: Take the sample cup to the suction point and
position the glass.

2) Reagent Tray Take the reagent to the suction arm. The tray of
the reagent has a continuous refrigeration function for 24 hours, and the temperature is maintained at
range of 2-8℃.

3) Reaction Tray: Secure the cuvette. Sample and reagent in reaction in the fixed cuvette
Set the thermostat to 37°C while performing the direct colorimetry.

4) Aspiration mechanism: aspiration of a quantitative volume of reagent from the bottle

of reagent and injection into the cuvette; then aspiration of the quantitative sample from the glass of
sample and injection in the cuvette. The aspirator mechanism with liquid level sensor function.

5) Mixing mechanism: Mixes the reaction solution contained in the reaction cuvettes.

6) Rinsing Mechanism: Drains the reaction solution and washes the cuvettes, adding
and draining the pure water. The eight-step washing design can clean the trays of
proper form.

24
 2.4 Operation and Specification
1) The reagent is open for selection. The examination parameter can be edited in a way
random.

2) Probes with the multi-directional anti-collision space system, when the probe encounters
any obstacle or resistance force will stop moving and trigger the alarm and the
previous exams will not be affected.

3) 120 buckets that can be replaced independently, the bucket has

high-intensity characteristics, corrosion resistance, and high UV resistance.

4) Adopts syringe importation, aspiring with precision.

5) Online control of the bucket and display of the reaction course in real time. Displays and saves
the real-time reaction curve. It automatically skips the unsuitable cuvette.

The reaction curve can be displayed and saved in real time.

The database data can be calibrated, and the parameter can be changed.
There is no need to re-examine and recalculate the test result directly.

8) The item examination sequence can be scheduled, independent cleaning can be

inserted among the items.

Various print formats.

The operator can create their own calculated item using various formulas.

11) Patient information is easy to edit.

12) Automatic alarm when reagent, sample, distilled water or detergent encounter
are insufficient and the residual solution is above the limit. The granting of reagent and
measurable quantities are displayed in real time.

13) Independent suction probe. The internal and external walls of the probe are polished.
Multi-directional washing with distilled water.

Advanced tracking system to detect liquid levels accurately. The probes

25
 can be automatically adjusted to the height of ascent or descent according to the
suction volume.

15) Select the test point again and recalculate when the sample is tested.
is abnormal; the calibration system will select the best point according to the
curve. Work efficiency is improved and reagent spending is saved.

Lifespan: 10 years.

17) High precision suction mechanism.

18) 24-hour standby mode, the system provides energy-saving patterns and
fast ligament.

2.5Technical Parameter
1) System: total automatic, discontinuous/optional, STAT function

Examination Speed: 280 tests/h (pure biochemistry)

Item storage: up to 1200

4) Item analysis: analyze 60 items online simultaneously (extendable)

5) Data storage: Infinite storage according to the space of

computer storage.

6) Testing method: End point, Rate (kinetic method), 2 end points, 2-point rate
(2-point kinetics), double wavelength, null, null reagent, null sample,
immunoturbidimetry etc.

7) 120 buckets, direct colorimetry buckets.

8) Calibration method: linear and nonlinear calibration, linear with multiple points, 6
standards at maximum (compatible with various fitting curves).

Sample tray: 35 routine positions, 5 standard positions, 3 QC positions, 2 of

STAT. The primitive tube whose specification is 5mL, 7mL, and 10mL or sample cup.

26
 specified can be placed in the sample tray.

Reagent tray: 60 reagent positions with cooling function, allowing

place the reagent bottle in various specifications.

11) Sample Volume: 2μL to 100μL, variable in 0.1μL

12) Reagent volume: for the item that uses double reagent for the exam, the first range
the reagent volume is from 5μL to 500μL, and the second is 2,500μL, variable in 0.5μL.

Minimum reaction volume: 150μL

Maximum reaction time: 10 minutes

Optical system: rear sealing spectrophotometry optical system, static, and series
integrals, 10 wavelengths to select (340nm, 405nm, 450nm, 492nm,
510nm, 546nm, 578nm, 630nm, 700nm, 800nm). The wavelength accuracy
does not exceed ±2nm.

Linear absorbance range: 0-3.0Abs, resolution 0.0001Abs

17) Light source: Long-life halogen lamp, 12V/20W.

Consumption: Distilled water 3L/H

19) Controle de temperatura37 ℃+/- 0.1℃

20) Washing system: singular washing system for the suction probe and mixer.
Eight-step washing system for bucket, professional detergent with enzyme and
alkali for selection.
Energy: 230~, 50/60Hz, 500VA

Fuse: T8AL 250V

Relative Humidity: ≤85%

24)Temperatura ambiente10 ℃~35℃

27
25) External insulation resistance of an isolated failure: ≤0.1Ω

28
 Chapter 3 - Principles of Measurement

3.1 Principle
Beer-Lambert Law:
When a parallel monochromatic light beam passes through an absorbing object.
(gas, liquid or solid), some photons are absorbed and the intensity of the light decreases fromI0
forIThe formula is:

I0
-1g ___ = ε LC
I00000

e: Proportionality factor
I: Intensity of light of refraction
I0Light absorption intensity

Measure, I0, e L, then calculate the concentration C according to the formula above.

3.2 Testing Methods

3.2.1 Final Test
The endpoint assay means that the concentration of the measured item is calculated from
agreement with absorbance at the end of the reaction process.

Final Point Rehearsal of 1 point

The final point assay in which the absorbance is measured at a point in time when
Absorbance stops changing at the end of the reaction process.

The reaction curve below explains the test.

Formula: Concentration = (calculated absorbance - blank reagent absorbance) × K

K is the absorbance coefficient, that is, the Standard factor

29
 Figure 3-1

Final Point Review of 2 points

Final point testing in which the measurement is taken twice at different points
(at the beginning and at the end of the reaction time) to obtain the difference in absorbance. Note
the reaction curve below.

Formula: Concentration = (Absorbance 2 - Absorbance 1) × K

K is the absorbance coefficient, that is, the standard factor.

Figure 3-2

3.2.2 Two-point test

The measurement is taken twice at different points (except at the beginning and at the end of
reaction time) to obtain the difference in absorbance. Observe the reaction curve below.

The formula is the same as that of the two-point endpoint test.

This essay is useful for solving some problem without specificity in any.
reaction.

30
 Figure 3-3

3.2.3 Testing Rate (Kinetic Method)

The concentration is obtained from the change in absorbance (ΔA/min) between the points.
of specified measurement. Observe the reaction curve below.

Range of Linearity of Enzymatic Reaction

Figure 3-4

31
 Chapter 4–Operation

4.1 Operation Stage

The operating steps of the instrument are shown below. Suggesting the
standard analyses execution every day after starting and performing control analyses.

4.1.1 Operation Stage

To turn on
4.2.1 Start URIT-8021A
4.2.2 Check the condition of the instrument

Sample preparation and

reagent
4.2.4 Preparation of
Sample

Create standard curve and

Place reagent and sample QC exam
Place the reagent in the instrument Put reagent in
Place the sample in the instrument instrument
Place the sample in
instrument
4.2.5 Standard Order and
Routine operation QC
4.2.5 Standard order 4.2.7 Start Analysis
4.2.5 QC analysis order 4.2.9 End
4.2.6 Routine Order

Sample preparation
of routine
Start the analysis
Put reagent in
4.2.7 Start Analysis
instrument
4.2.7
Place the sample in the
instrument
Analysis 4.2.6 Routine
4.2.7 Start Analysis
4.2.9 End

Film
4.2.9 End
End of test 4.2.9
4.2.8 STAT analyses

32
4.1.2 Start
First, check the distilled water, detergent, and residual solution, and turn on the
cooling switch of the analytical unit and the computer, wait
approximately 30 minutes until the instrument stabilizes.

CAREFUL
1) There are two switches, analysis switch and switch of
refrigeration. Before analyzing, please turn on the switch of
cooling first and only then turn on the switch
analysis.
Please cover the reagent tray to maintain the effect of
refrigeration.

4.1.3 Create Standard Curve

It is recommended to perform standard analyses every day to obtain results.
best. Here are the steps for standard analyses.

1) Put the reagent in the reagent tray and place a known concentration of
standard solution in the standard position of the sample tray.

Apply to the system for standard analyses.

Click "exam" to start standard analyses.

4) Confirm that the new standard curve has been created.

4.1.4 QC Examination
After the standard analyses, it is necessary to perform QC analyses to verify the
instrument precision. QC data is saved in daily operations to make
QC as the basis for analyses.

There are two types of QC analyses: with variation within the QC day and variation between.
one day and another QC. Within-the-day QC is to check the measured data within a
day. Between days QC is to verify the measured data on different days. It is recommended
measure two control samples at different concentrations every day, and each
The control sample must be measured at least twice.

Here are the steps for QC analyses.

33
1) Place the control sample in the control position of the sample tray.

Apply to the system for control analysis.

Click 'examination' to start QC analyses.

4) Check the QC map. (Refer to 5.4.3 for the QC table and 6.3 for rules of
QC)

4.1.5 Patient Sample Examination

The operational steps are as follows:

1) Place the serum, urine or other patient samples on the sample tray

2) Apply to the system for routine item analysis

Click 'exam' to start

4) Repeat steps 1-3 if necessary

5) Check the result and, if necessary, revise and change it.

4.1.6 End
Perform the rinse and log off the system after finishing the analyses and then turn it off.
the force.

4.2 Basic Operation

4.2.1 Start
Start by following the steps below:

1) Connect the main power of the analyzer

2) Turn off the computer

3) Open the top cover of the instrument

4) When starting the operating system, a logout window will appear like this, figure 4.2.1
34
 Figure 4-1

5) Enter the registered doctor's name and the corresponding password to log into the system.
and operate the analyzer.

CAUTION
The operator authorization management is applied to limit certain
functions for the low authorization operator, this benefits the operator
to manage the software rationally.

NOTE:
Please refer to figure [Link] to configure the name and password.

NOTE:
The device has a 24-hour standby mode function, automatic mode of
low consumption and configuration with just one key.

4.2.2 Check the Status of the Instrument

Verifique o estado de instrumento antes de executar

1) Check the distilled water, detergent, and residual solution. If the distilled water or
if the detergents are below the level, refill them. Empty the waste drum first
the analyses.

Biological Hazard
DO NOT TOUCH the detergent or the residual solution. If it adheres to the hands or
clothing, wash with water immediately. If it splashes in the eyes, wash with water
immediately and consult a doctor.

2) Check that the reagent caps have been removed and the remaining volume.
the reagent should be sufficient for your analyses.

35
 CAUTION
If the remaining volume in the reagent bottle is insufficient for analyses,
replace the entire reagent bottle. Do not refill the reagent in the bottle.
If it is recharged, data errors may occur.

3) Check the suction and mixer probe. Ensure that the suction probe does not
be blocked. Ensure that there is no adherence of stains and crystals on the
surface of probes and mixer.

4.2.3 Reagent Preparation

1) Make sure you are using registered reagents. Read the instructions for
reagent and set the parameters appropriately before analyses. For
item parameter configuration, see 5.2.1 and 5.2.2.

2) If the reagent is insufficient, replace it with a new bottle. Place the bottle of
reagent in the specified position according to the pre-defined reagent parameters
configured.

The reagent should be stored at a temperature of 2-8. ℃Exposure to air for

Prolonged exposure can deteriorate the reagents.
Biological Hazard
Be careful not to spill the reagent. If the reagent is spilled,
Wipe the area with a dry cloth immediately.

4.2.4 Sample Preparation, Standard Solution and Detergent

[Link] Sample Preparation

Add samples to cups or special sample tubes, and then select the
sample position corresponding in the examination interface.

CAUTION
Before transferring the samples, observe their appearances and shapes to see if
there are icters, hemolysins, or chyle.

[Link] Preparation of Normal Solution

Add the appropriate volume of standard solution to the sample cup and place the cup
in the standard position.

36
[Link] Preparation of detergent
Dilute the detergent proportionally, and then add it to the detergent drum.
Make sure that the solution level does not exceed the highest line marked on the drum.
of detergent.
NOTE:
Do not confuse the detergent, for example, acidic solution and solution
alkaline will produce toxic gas if mixed.
If detergent spills, wipe the area with a dry cloth or paper.
absorbent. Leaving it spilled will cause erosion of the parts of
instrument.

Biological Danger
1) When opening the detergent drum lid, be careful to avoid
touch the solution. If the detergent sticks to your skin or clothes, wash them
with water.
If the detergent splashes into the eyes, wash with water immediately and
consult a doctor.

3) 4.2.5 Standard and QC Register

QC Record
1) Select "QC --> QC Configuration" to set up the QC parameter.
2) Select "Exam -> QC", then apply the QC item exam.
3) The QC data is processed automatically by the system after finishing the
analyses.
NOTE:
The QC test can be done when the routine examination is being carried out, it's just
set 'sample position' as QC position, like position C1 or C2.
The system will identify you as QC and process the QC result automatically.

Standard Record
1) Click 'Reagent->Routine items->Default configuration' and configure the
standard solution parameter.
2) Click 'EXAM—>STANDARD' to apply the standard.
3) Save the data automatically after finishing the exam.

37
4.2.6 Routine Sample Registration
It is necessary to register analytical items and patient information for each sample
routine before the analysis according to the form.

Figure 4-2

There are two ways to write the to-do list:

1) Single sample applied operation.
Operation applied to reexamine the single sample.

[Link] Edit Single Sample Review Form

Select 'Routine Analyses' from 'Chemistry Analyses' or click the shortcut icon

to enter the 'Routine Insertion Screen.

2) Configure the basic information for sample identification, sex, age, cup of
sample, Noinitial of buckets and analysis date, etc.

3) Select analytical item by clicking the target item. A new click can toggle between
"selecionar" e "desfazer seleção".
Click "ADD" to add the edited sample to the list.

5) Click "NEW" to edit the next sample. Repeating steps 2 to 4 can

add more sample analyses.
NOTE:
Select the combined item directly to choose the analytical item. To edit
for a combined item, see 5.2.3; to edit a chemistry item, see 5.2.1.

38
[Link] Edit the Reexamined Single Sample Form
1. Operate according to steps 1 to 3 of the 'Single Sample Application'.

2. Click 'COPY'. Enter the number of repetitions and select 'Same Cup'
(putting the symbol "√ ").

Figure 4-3

NOTE:
If the "Same Cup" is not selected, the system will recognize the
current sample position as the initial sample position and will arrange
the exam samples in different positions for the same items
analytical.

The created list will include the sample ID, the No of sample cup and the analytical item.
See figure 4-4.

Figure 4-4

39
 The "Pre-Dilution" function can be used in the created list.

Function of the keys

Create new sample ID and sample cup

Add to the current work list

Copy the same group of items for more samples.

Pre-dilute selected item.

Delete the selected item

Test the content of the current work list.

4.2.7 Analysis
Do the following after finishing the preparation:

1) Check parameter configuration, sample positions, and reagent positions.

2) Check the item list, content standard, and QC.

Click on "Exam" to enter the Exam Screen.

4.2.8 STAT Analyses

For a sample that needs to be tested immediately, you can use the function
of STAT analyses.

Click "STAT" or click the icon to perform a sample test of

emergency. Specific operation is the same as routine sample. See figure 4-5.

40
 Figure 4-5

CAREFUL
The STAT Entry Screen is similar to the Routine Entry Screen. Pay attention
be careful not to confuse them when conducting analyses. The STAT samples
they should be placed in the positions of STAT, such as E1, E2, etc.

CAUTION
STAT analyses are performed only after the start of the examination.
routine.

4.2.9 End of Analyses

Routine
When measuring the last sample, the sampling stops automatically and the data is
processed and stored.

Emergency exit
If you need to abort the ongoing measurement, press the 'EXIT' key.
In this case, the measurement is canceled.

CAUTION
If the emergency exit function is executed, the entire examination of
the applied sample will stop and the data will be lost. Reapply if
there is a need to continuously test these samples.

41
4.3 Obtain Result
Check the exam result after completing the analyses.

4.3.1 Sample Information Register

After the measurement, enter the corresponding patient information for
complete the exam report.

Select 'Sample Result Record' or click the icon to enter the

registration interface. Sample information can be recorded in this interface,
como "Data de Relatório", "ID de Amostra", "Nome", "Sexo", "idade", "ID de paciente
internalo of Patient

Click "Calculated Item", the item will be displayed. Click "SAVE" to edit the next one.
sample and repeat this operation until the entire sample editing is complete.

Printing: Offers various printing formats for different needs.

Compatible with print mode in Chinese/English.

4.3.2 Modification of Exam Result

Click 'exam data -> result search -> item sequence' to
modificar o resultado quando aparecer resultado anormal. O sistema exibirá os dados
of the selected item. It is recommended to calculate the coefficient according to the formula
below

Coefficient = target value of QC / actual value of QC

Insert the calculated data in the 'Modify' column, click 'Modify' and the system
will modify all data within a day under this item automatically, then
click 'SAVE' to save the data.
CAUTION
Take objective factors, such as clinical symptoms or sample character,
in consideration before deciding to modify the exam results. The
modified coefficient must be calculated in combination with the
QC results in recent days. To avoid diagnostic errors, doctors
lab professionals must oversee the modification of
exam results.

42
4.4 Analytical Result Research

Select "Analytical Result Search" or click the icon to enter in

search interface. The analytical result can be searched in this interface. The
the system provides several index functions, such as analytical date search, name of
patient, Noof the patient, doctor, etc.

NOTE:
Reports can also be printed according to demand.
laboratory on this screen

4.5 Display of Analytical Curve

The system provides the 'Analytical Chemical Data Screen' interface for the
Laboratory to analyze the result in detail. Select 'Analytical Curve Display'
to analyze the analytical data. In addition, this function can examine the QC and the curve
standard, and analyze the accuracy of the QC and the standard.

4.6 Database Maintenance

Backup or compress various exam data to avoid data loss.
Database maintenance consists of two parts. Operate according to the
following steps:

4.6.1 Database backup

Select "Maintenance".

Select 'Database Backup' to back up the data by date

according to the laboratory's demand.

Select 'Backup' and exit.

4.6.2 Database Reduction

Select 'Maintenance'.

2) Select 'Database Reduction', click 'run' and then it will appear the
database compression dialog box.

3) Compress the data according to the requirements.

43
4) Select 'Reduction' and exit.
NOTE:
The laboratory control system to back up data
manually as necessary, as the system cannot back up
data automatically. After the backup, the data will be deleted.
automatically. You need to restore if you need to check the data
the backup.

44
 Chapter 5 - Advanced Configuration

5.1 Chemical Analysis

5.1.1 Configuration of Routine Item Parameter
The configuration of the routine item parameter is the first step in chemical analyses.
Configuring the parameter accurately can ensure the accuracy of the analytical result. The
basic factors for each analytical method include the name of the chemical item, method of
ensaio, comprimento de onda, volume de reagente, posição de reagente, tempo de
incubação, medição de tempo, volume de amostra, valor baixo nulo, valor alto nulo, valor
below normal, high normal value, unit and decimal, etc. The steps for configuration are
the following:

1) Select the 'Routine Item Parameter' or the icon to enter the interface of
parameter configuration

2) Enter the item name, include the abbreviation and the other name. See figure -1.

Figure 5-1

3) Configure the parameter to add a new analytical item according to the instructions
the laboratory file of the item. See figure 5-2.

Figure 5-2
Definition of Main Parameter:

1) Experiment: Endpoint, method rate (Kinetic method), 2-point endpoint, index

two-point method (two-point kinetic method), Standard Multiple method and
double-wavelength method, etc.
45
2) Wave. 1: Measured wavelength. For Double-Wavelength Method,
"Onda.1" is the primary wavelength.

3) Wave.2: Secondary wavelength for Double-Wavelength Method.

If 'NONE' is selected, the Single Wavelength Length method will be valid.

4) Decimal: decimal position for test results.

5) Unit: Unit for analytical result.

6) Priority: PRI-1 with the highest priority level; PRI-9 with the lowest priority level
low.

7) Modified Factor: modifies the standard factor of the item.

8) Fator Padrão e Valor Padrão: Ponto final, Taxa do método (método Cinético), método
Permanent Time and Double-Wavelength method are all analyzed
with standard and factor.

See figure 5-3. Click the icon select default position and enter default value
corresponding. If the Factor method is adopted, the corresponding standard factor needs to
to be inserted, and it is necessary to set the default value as "0". As shown in figure 5-3,
if the standard number is greater than "1" (not including "1"), this is the multiple standard method, then
it can be used.

Figure 5-3

Sample volume to be aspirated for the cuvette. Please set the volume accordingly.
with the reagent instruction and corresponding laboratory file.

1) Volume of the First Reagent: The volume of reagent to be aspirated in the cuvette in
Single Reagent Method. Regarding the reagent volume in the Reagent Method
Duplo, please consult the reagent instructions and the laboratory demand.

46
2) Volume of the Secondary Reagent: Regarding the volume of the secondary reagent in the Method
for Double Reagent, please consult the reagent's instructions and the demand for
laboratory.

3) Incubation Time: For endpoint assay, the incubation time is of the mixture
of sample and reagent at the end of the reaction process. For the Two-Point test,
the incubation time is from the first measured point to the second measured point. Two
incubation times must be configured in the Double Reagent method. Please
consult the instructions of the reagent and the laboratory requirement.

4) Test Point: The number of test points when continuously reading the absorbance after
the incubation.

5) Normal Value Range Configuration: null low value and null high value are used
to evaluate the quality of the reagent, please consult the maximum absorbance value for
insert the value. The low normal value and the high normal value are used to judge the
analytical result. The linear range can be included when consulting the information of
corresponding reagent.

NOTE:
The laboratory can configure the reference value range of the item accordingly.
with the local situation of the real exam and the laboratory statistical data.

6) Please click 'SAVE' to complete the setup after configuring all the
parameters.

CAREFUL
All new configuration data will be lost if 'SAVE' is not clicked.
be clicked.

5.1.2 Configuration of Special Item Parameter

The software system expands the function of 'Special Item Parameter' to
operators. It allows analytical results detected by other instruments
can be transmitted to the software system in a unified print format.
See figure 5-4

1) Enter the name of the corresponding item and another name.

47
 Figure 5-4

2) Select the data type between 'Char' and 'Float'.

The exam results will be indicated with a character system, such as "+".
_
Float: The exam results will be indicated with numerical data. The decimal, value
high normal and low normal value of the result can be entered.

3) Click 'SAVE' to complete the entire setup.

5.2.2 Combined Item Configuration
The analytical item will be grouped and must receive a separate code with the name 'Item'
"Combined". Add or delete an item according to the laboratory requirements. The item
combined will appear in the "Combined Item Region" interface for later analysis
that the correlational configuration has been made.

NOTE:
Combined Item means multiple items combined into a separate code, that
It is a process; But 'Combined Item' becomes a code after the 'Combined Item'
has been proceeded, what is a name.

5.2.3 Configuration of Calculated Chemical Item

Some analytical items need to be calculated and the corresponding result serves to
assist the doctor in making the diagnosis. These results are the calculated results, and the
items named as calculated items whose function is completed when configured in the selection
of "Calculated Item Configuration".

NOTE:
Pay attention to replace the '-' with '_' in the item name when inserting
an arithmetic expression.

5.2.4 Item Display Sequence and Printing Configuration

Items can be sequenced for display and printing, including the items.
analytical, external items, and calculated items. Click "Display Sequence Configuration"
48
from Item and Printing" to enter the configuration interface.

5.3 Special Analyses

5.3.1 Standard Analyses and QC
Applied pattern and QC analyses can be done in this interface. Please see 4.2 for
specific operations.

5.3.2 A/D Signal Reading

The A/D value and absorbance value of all filters can be read. This function is
only for employees authorized by MH Lab.

CAREFUL
MH Lab is not responsible for any consequences resulting from
Change of values A/D without permission or authorization from MH Lab.

5.4 Quality Control Management of Chemistry

Multi-level QC system support test. The correlating parameter of QC must be

be set up for QC testing. Click "Chemical QC Administration" to
configuration.

Figure 5-5

5.4.1 QC Materials Configuration

Some relevant parameter materials will be accompanied by QC materials.
delivery. The general characteristics of the QC material can be confirmed by inserting its
basic data. Laboratory staff can enter the basic parameter into the system
when introducing new QC materials. The 'QC Setup' includes the basic setup
target value, SD value, and lot number.

49
 NOTE:
The QC Chemistry Item list is added or deleted in the selection of 'Parameter of
Routine Item.

NOTE:
The laboratory must set the target value and SD value for the new material.
QC. The target value must be defined according to the determination method.
presented. The parameter provided by the manufacturer is for reference only.

5.4.2 QC Result Processing

Select a QC chemistry item, the system will display the corresponding information.
from QC automatically. Laboratory staff will process the QC result
by entering data and saving it in the system.

5.4.3 Chemical Diagram Analyses of QC

Select a QC chemistry item, the system will display the corresponding information.
from QC automatically. The laboratory staff will display the QC diagram and
print when inserting the date. The parser provides several QC analytical methods, including
Westgard multi-rule and Levey-Jennings QC rule.

NOTE:
The laboratory may select individual QC standards, see 6.3 for the diagram
of analytical QC method.

5.5 Systematic Parameter Configuration

Systematic parameter configuration is introduced for individual configuration of
laboratory.
5.5.1 Hospital Information Configuration
The hospital setup includes 'examination doctor setup', 'setup of
["clinical doctor","configuration of the responsible department"]

[Link] Examination Physician Configuration

Statistical analyses of the work of the examining physician, convenient for administration
from the laboratory. The figure follows below:

50
 Figure 5-6

When starting the URIT-8021A biochemical operating software, figure 5-7 will appear,
suggesting to insert the name of 'Examination Doctor' and the corresponding 'Password', configure the
work cord and name it here. The work code is used for work registration
and print, use the exam doctor's cord to enter the corresponding password in the
cited figure.

Figure 5-7

The corresponding password can be set in figure 5.5.1-2, if another password exists.
In the system, the archived input of 'Old Password' will appear in the insertion state.
The system will save the new password and pattern as the operational password.

The high priority will allow the examining physician to modify the 'Item Parameter of
["Routine","Combined Item Configuration","Calculated Item Configuration"]
while low priority will not allow it.
51
 NOTE:
The system software adopts strict management of multiple authorities to
ensure data security. Please remember and do not share your password.

[Link] Clinical Doctor Configuration

The cord can be used to represent the doctor, as a number, symbol, or letter, the
The doctor's name can also be used. Configure according to the specific condition.

[Link] Configuration of the Responsible Department

The cord can be used to represent the department as a number, symbol, or

letter, the department title can also be used. Set according to the condition
specific.

NOTE:
"Clinical Doctor" and "Responsible Department" are configured by the person themselves.
laboratory.

5.5.2 Table Color Configuration

The laboratory can configure the color of the table individually, see figure 5-8.

Figure 5-8
52
5.5.3 Configuration of Serial Communication Port and Operator Name
Select the communication port configuration dialog from the menu.

Figure 5-9

The system will automatically test all communication ports and a box of
a dialog will appear for the operator to select the communication port. The name of the operator
it must be inserted into this function module, and the name will be the title of the report sheet and
other diagrams.

53
 Chapter 6 - Quality Control of Analysis and Calibration.

6.1 General Information

The reliability of the test result is determined by two aspects:

One of them is accuracy, which means that the test results will be stable in
repetition. Accuracy can be ensured through the establishment of a control system
perfect quality of the environment; the other is accuracy, which means that the results of
tests are close to the target value. Accuracy can be ensured through measurement and calibration
adequate. Therefore, it is necessary to select the certified control sample and the solution
of calibration, and use them strictly according to their instructions.

6.2 Quality Control

6.2.1 Type of Quality Control Materials
1) Freeze-drying control, liquid control, and mixed serum control, classified
according to the physical property.

2) Control sample of fixed value and non-fixed value, classified according to the
presence or absence of fixed value. A different inspection body may choose more
of a control like quality control.

6.2.2 Use and Storage

1) Use the control sample following the usage instructions provided by the supplier
control.

2) Ensure that the quality of the redissolved control solution of the sample of
Freeze-dried control is stable.

3) Make sure that the dilution ratio is accurate and consistent every time you do it.
lyophilized control sample should be re-dissolved.

Do not shake the control sample quickly when redissolving the sample.
lyophilized control.

Store the control sample according to the requirements. DO NOT use products
defeated.

6) Execute QC analyses under the same operational conditions as the analyses of

sample.

54
6.2.3 Target Value, SD, and Control Limit Configuration
The target value of QC and control limit are usually provided by the supplier of
control samples, you can also determine them through the following methods:

1) Configuration of interim target value (average value) and SD

Perform QC analyses at least 20 times with a new batch of control samples.
Calculate the mean value and standard deviation of the QC data obtained.

2) Configure the regular target value (average value) and SD

Get the average accumulated value of 20 original QC dice as the target value
while the average accumulated value of 3 to 5 months of QC data like the deviation
standard.

3) Configure the control limit

The control limit is the multiplier of the standard deviation. Control limit of the item
analytical is determined according to different CQ rules.

6.2.4 QC Procedures
The QC procedure consists of two systems, they are "QC Administration of
Chemistry and QC Analysis. Select "Chemistry QC Management" in "Analyses of
Chemistry, its function is to set the parameter before QC analysis and processing.
QC data, such as the target value configuration of QC, QC lot number, and SD value.
etc. Select 'QC Analyses' in 'Special Analyses' to start QC Analyses, the
QC data will be saved in the system automatically and a QC diagram will be generated.
for chemistry analyses; QC analyses can be added to the test interface
routine. See 4.2.5 for application of QC Analyses.

6.3 Quality Control Method

6.3.1 Levey-Jennings Method
The 1-2S rule exceeding the mean value ±2SD is considered out of control.

The 1-3S rule exceeding the average value ±3SD is considered out of control.

55
6.3.2 Westgard QC Rule
1-2S Notice
1-3S Random error
2-2S Systematic error
R 4s Random error
4-1S Systematic error
10X Systematic error

Figure 6-1

Rule 1-2s: When a QC result exceeds ±2SD, consider it a 'warning' in the next
standard.

Figure 6-2

56
Rule 1-3S:
When a QC result exceeds ±limit 3SD, this is considered a random error.

Figure 6-3

Rule 2-2S: The result of QC of two successive tests where both exceed +2SD or -
2SD, this is considered as a systematic error.

Figure 6-4

Rule R-4s: When a QC result exceeds the mean + 2SD, and the other exceeds -
2SD, this is considered a casual error.

Figure 6-5
57
Rule 4-1s: When four consecutive QC results exceed +1SD or -1SD, this
is considered a systematic error.

Figure 6-6

Rule 10X: When there are 10 consecutive falls in QC results on the + or – side, that is
judged as systematic error.

Figure 6-7

6.3.3 Reasons for Random Error

Below are the possible reasons for random error:

1) Imprecise volume poured out (sample, reagent)

The suction mechanism is leaking; air bubbles in the flow path; probe
contaminated; defective reagent injection, etc.

2) Failure in the optical system

The lamp is faulty.

3) Metamorphic reagent
Metamorphic reagent
58
Poor quality control of the exam
Use of wrong control sample;

Improper washing
Improper washing of mixer

Bad mixture
The depth of the mixer in the bucket is not correct; mixer mechanism
defective.

6.3.4 Reason for Systematic Error

Imprecise pattern
The solvent of the standard solution is inadequate.

Metamorphic reagent
The reagent is metamorphic, and the lot number varies.

Temperature
The temperature control is inadequate

6.4 How to Deal with Out of Control

1) Fill out the out-of-control report and inform your laboratory supervisor.

2) Quickly read the operating procedure to discover possible reasons

3) If no obvious error is found, follow the steps below to obtain a check-

up better.

Reexamine the out-of-control item using the same control sample vial.
Strictly follow the operational flow to check if the out-of-control item is
due to incorrect operation or random error. If the result of the new test is outside
if within the acceptable range, proceed to the next step.

Reexamine the out-of-control item using a new control sample vial.

(same batch). If the result of the new exam is within control, the previous vial of
The control sample may be the cause. If the result of the new test is still
out of the allowable range, proceed to the next step.

Reexamine the out-of-control item when using a new batch control sample. If the
59
 if the result of the new test is under control, the previous batch of control sample may
be deteriorated. Then check the expiration date and the condition of
storage. If the result of the new exam is still outside the acceptable range,
proceed to the next step.

Carry out the maintenance of the instrument, reexamine the out-of-control item. Check the
state of the instrument; check if the light source or the filter has been changed or not; and if
there is a need to wash or replace the cuvette. Additionally, replace the reagent. If the
If the result of the new one is still outside the range, proceed to the next step.

Recalibrate and reexamine the out-of-control item. Perform the calibration when using the
new calibration solution. Proceed to the next step if the result is still out of range
from the strip.

Get technical support. If you can't get the result in the control after executing
After the five steps above, contact the reagent manufacturer or MH Lab for more information.
technical support.

6.5 Calibration and Procedures

The calibration solution contains the known amount of the object, which is used to
calibrating the value of this method, the calibration solution involves the method, reagent and
instrument. The calibration solution function is to reduce or eliminate systematic errors
caused by instrument and reagent. It is better to use human serum matrix to reduce
effect of the matrix.

6.5.1 When to calibrate

It is recommended to perform calibration every six months or under the following situations:

When installing and running the instrument for the first time.

Upon changing the reagent lot number or its type, unless specified by
laboratory that the change will not affect the accuracy.

After replacing important components, such as the bulb, mechanism of

sampling, probe, or cuvette etc.

After performing preventive maintenance on the instrument.

When the control result shows deviation or abnormal trend, or is outside the
60
 acceptable range and cannot be corrected by routine tests.

6.5.2 Calibration Procedures

There are two ways to perform calibration:

1) Apply standard analyses in "Special Analyses"

Select 'Special Analyses' to apply standard analyses for each item, the data
Analytics will be saved in the system automatically for analysis.

2) Select the item that needs to be calibrated in 'Routine Item Parameter'

a) Insert and save the calibration material concentration value in the standard column.

b) Enter the 'Routine Analyses' interface, if 'Standard Material Concentration'

having been inserted when configuring the analytical item parameter, the selection of this item
will appear on the 'Standard List'.

c) Select the item in the 'Standard' list for standard analyses. The analytical result will be
processed and saved automatically and will be the default for this item (standard factor).

NOTE:
Set the system standard of the value of 'Standard Factor' to 1 when
create a new item; and the system will calculate the result according to the factor
standard "1" if not modified.

NOTE:
It is recommended that all calibration work must be recorded and
compatible in documents. What should be emphasized is that the serum of
fixed value control should never be used as a standard solution.

Note
The calibration cycle can be set manually or automatically.

61
 Chapter 7 - Maintenance and Check Up

This chapter mainly introduces maintenance knowledge; and involves the

maintenance of the main components.
7.1 Manutenção do Analisador
To keep the analyzer in its best working condition, periodic maintenance
for specific components it must be done, as it can ensure operation in state
of flawless operation of the analyzer and stabilize the test result.

Figure 7-1

7.1.1 Probe and Mixer Rinse

Select 'Probe and Mixer Rinse' from the 'Maintenance' menu or click the

icon to rinse the probe and the mixer. It is intended to ensure cleanliness and
avoid residues in the piping. The rinsing time can be configured. See figure 7-2.

Figure 7-2

To initialize all moving components in the initial position.

Click "Rinse" to start.

62
 NOTE:
Please perform the rinsing at least 5 times when turning the instrument on and off.

7.1.2 Bucket Rinse

Select 'Bucket Rinse' from the 'Maintenance' menu or click the icon for
rinse the bucket. It is intended to maintain cleanliness and avoid residual solution. The interface
functional is as follows:

Figure 7-3

NOTE:
It is very important to rinse all the trays at least once when turning on.
turn off the instrument.

7.1.3 Reading of Cuvette Signal

Select 'Cup Signal Reading' from the 'Maintenance' menu or click the icon

It aims to eliminate the difference between cuvettes. Test the system and save absorbance.
zero of each bucket separately, as this also contributes to the exam calculation
retrospective chemistry. In the following figure, the number in the left box is the number of
The buckets and in the upper frame are the wavelengths. All null data from
buckets are saved in this interface.

63
 Figure 7-4

Functional Button

Fill the whole bucket with distilled water

Pump all the distilled water from the bucket. The function is effective only
if there is water in the bucket)

The absorbance reading of all the cuvettes and the result do not
will be saved

Repeat the absorbance reading of all cuvettes, from the average value.
and save them.

Turning the page, the absorbances of 15 cuvettes and 120 will be displayed.
no total.

7.2 Maintenance
Favor fazer o seguinte trabalho de manutenção para manter o analisador em seu melhor
operating and safety status:

64
7.2.1 Daily Maintenance
1) Before the daily work, make sure that the detergent and distilled water are sufficient.
for your analyses. If they are insufficient, fill the detergent drum and the drum
of distilled water. Empty the waste drum if the residual solution exceeds the line
notice marked on the waste drum

2) Check the mechanical movement of the suction probe of the mixer. Check if the
the probe is clogged or not. Examine the exterior of the probes and mixer for any
contamination or dirt. Clean them if necessary.

Biological Hazard
Use protective gloves to avoid contact with the chemical solution. If it
spill on the human body, wash with water immediately and consult a
doctor if necessary.

3) Execute the rinse of 'suction probe and mixer' at least 5 times and then
less one time the rinse of 'bucket'.

4) Execute "Add Water" before turning off to ensure that the bucket is full.
distilled water.

7.2.2 Weekly Maintenance

1) To reduce cross-contamination, it is necessary to wash the suction probe and the
weekly mixer. The probe and mixing bar can be washed
automatically by the maintenance procedure, or manually according to
the following steps:

a) Prepare items: Alcohol, Cloth, nozzle cleaner.

Clean the exterior of the suction probe and the mixer using a cloth.
moistened with alcohol.

c) Insert the mouth cleaner at the tip of the probe to clean it.

2) Rinse the needle according to the method that rinses the aspiration probe and the
mixing bar

65
 NOTE:
Be careful not to bend or scratch the probe while cleaning them.

3) Select 'null bucket' to check if the null bucket value is within range.
acceptable or not. If it is outside the range, remove the relevant trays next to the
reaction tray cubicle shelves. Observe the cubicles carefully and the
replace if necessary.
NOTE:
To receive ideal data, DO NOT read the null cuvette until the lamp
from the source of the source to be stable. It may take 25 minutes to complete the time of
heating.

NOTE:
Be careful not to scratch the reaction vials when removing them.

Biological Hazard
Use protective gloves to avoid contact with the chemical solution. If spilled
on the human body, wash immediately with water.

4) Turn off the instrument's cooling switch, using a cloth dampened with
water or detergent; wipe the instrument panel.

CAUTION
Operate carefully to avoid scratches on the instrument.

7.2.3 Monthly Maintenance

1) Carry out just like the weekly maintenance.

2) Check the flow paths and tube connectors for leaks or blockages.

7.3 Maintenance of Disuse for Prolonged Time

If the instrument is unused for more than two days, execute the following steps first
to turn off and then to turn on.

1) Add new distilled water to the distilled water drum, meanwhile, add
detergent to the detergent drum.

66
2) Enter the maintenance program to wash the flow paths and buckets at least.
twice.

7.4 Preventive Maintenance

Periodic checks and inspections ensure the performance of the instrument. It is therefore
It is recommended to perform preventive maintenance periodically.

Preventive maintenance includes not only checking and repairing but also
following:

Routine check and periodic check.

2) Periodic maintenance for parts subjected to prolonged use or wear.

3) Ensure a sufficient quantity of spare parts.

4) Improvement and control of operational conditions, such as temperature, humidity,

water quality, dust and gas, insects, foreign substances, etc.

67
 Chapter 8–Problem Solving

This chapter lists the various operational problems, along with the probable causes and
recommended repairs to quickly and easily fix the problem. If the problem still
If the problem persists after following the recommended repair, contact MH Lab for technical support.

CAUTION
Handle the functioning problem with extreme care and confirm if it is
It is necessary to cut the power supply at the first problem.

Biological Hazard
Use protective gloves to avoid contact with the chemical solution. If spilled
about the human body, wash immediately with water.

8.1 Troubleshooting Guide

To eliminate the problem of functioning easily and correctly, the operators must
read the Operation Manual and be familiar with routine operation and maintenance
do URIT-8021A.

In general, there are three steps to address the functioning problem:

Step 1: Confirm Operational Issue

The operators must not only confirm the malfunction issue, but
also to know clearly what should be your normal state when the problem of
functioning eliminated.

Step 2: Classify the Operating Problem

The operational problem can be classified into three types.

Malfunction related to hardware

Software-related failure

Malfunction related to operation and analysis.

If the malfunction involves hardware or software, contact your local distributor

or the MH Lab. If the operational and analytical issue is related to the operation and analyses, consult
the problem-solving table below for solution.
68
 Step 3: Eliminate the Functioning Problem
The maintenance engineer authorized by MH Lab takes appropriate measures to
fix the problem.

The operators can also eliminate the problem of functioning under guidance.
of the maintenance engineer.

8.2 Obtain Technical Assistance

Our Customer Service is available to help if the problem is beyond the

scope of this manual or if you need further technical assistance from MH Lab. Before
please identify the following information:

1) The model of the instrument;

The serial number of the instrument;

3) The specific symptom and the operational condition;

4) The data and report related to the issue.

8.3 Problem Solving Method

The problem-solving table below presents various problems and wrongs
functionings that may occur during operation. If the problem cannot be
resolved by the recommended methods, please contact MH Lab.

NOTE:
To replace parts of the instrument, consult Appendix A.

69
 Table 1 Problem Solving
SN SYMPTOM PROBABLE CAUSE REPAIR

1) Connect the electrical wire correctly.

Check if the electrical socket is on
Incorrect connection with the
good conditions.
electric wire.
Replace the fuse (8A)
No electricity 4) Confirm that you have selected the connector
with power receptacle.
correct in [System Parameter—
The Instrument no 3) The safety fuse
1 parameter of instrument
it is active when it is melting
COM configuration
the power is on. 4) A COM interface
5) Make sure that the RS232 cable of
inadequate is communication is connected to the PC
selected.
correctly.
5) Error in the cable
6) If the problem still persists,
communication.
contact your local distributor or MH
Lab.

1) Select [Maintenance—rinse
of the bucket], check if the buckets of
reactions are dirty or damaged.
Dirty or damaged bucket
Replace them if necessary
2 Null bucket error
Wear of the light source
2) Replace the light source.
3) If the problem still persists,
contact your local distributor or MH
Lab.
Check or replace the support of
Poor support contact lamp
3 The lamp is weak from the lamp. 2) Replace the light bulb.
Burnt lightbulb. If the problem still persists,
contact your local distributor or MH
Lab.
Check the path tubes
flow. Reconnect or replace the tubes if
Air leaks in the
for necessary.
flow paths.
Reconnect the meter regulator.
Inadequate volume 2) Air bubbles are
Release the air bubbles.
4 of sample of formed in the regulator of
3) Clear or replace the probe.
reagent or meter.
4) Check the magnetic valve and the
aspirated. The probe is clogged.
replace if necessary.
4) Problem in the valve
If the problem persists,
magnetic.
contact your local distributor or MH
Lab.

A water you
Path tube of
detergent no Reconnect the tube or replace it.
flow has a leak.
saem by Clear the pipe.
5 2) Path tube of
washing pool 3) Replenish the water or detergent.
the flow is blocked.
of the probe or by the If the problem persists,
Water or detergent
wash basin contact your local distributor or MH
they are sold out.
of the mixer. Lab.

70
SN SYMPTOM PROBABLE CAUSE REPAIR
Reconnect the tube or replace it.
1) Tubo de caminho de 2) Desobstrua o tubo.
the flow has a leak. 3) Check the vacuum pump and to
6 Add or drain
the water is abnormal
2) Replace the path tube if necessary.
the flow is clogged. If the problem still persists,
3) Vacuum pump error. Contact your local distributor or MH
Lab.
1) Check the light connection wire or
A certain part replace the coupling.
7 The light switch is with 2) If the problem still persists,
the mobile is out of
short circuit or break. contact your local distributor or MH
control.
Lab.
1) Check the level sensor board
of liquid and replace it if it is
1) Level sensor plate necessary.
The liquid is defective. Reconnect the level sensor board
8 Level sensor of 2) Want contact with the board liquid.
liquid does not work
the level sensor of 3) If the problem still persists,
liquid. contact your local distributor or MH
Lab.
1) Select maintenance –--
1) The bucket is dirty or
"rinse bucket" to check if the
break The bucket is dirty. Clean it or replace it.
2) imprecise volume of
bucket.
reagent or sample
2) Check the sample injector and the tube
aspiration.
to see if there was a leak.
3) A lamp is
3) Replace the light bulb.
Result deteriorated
9 4) Configure the parameter accordingly
test imprecision 4) Item parameters
with the operation manual. Ensure-
or bad repetition. analytical are I know that the instrument is well grounded.
configured in such a way
by means of the grounding pole.
inadequate.
5) Check if the reagent is certified.
5) grounding wire is
Execute the calibration again.
absent from feeding of
If the problem still persists,
energy.
contact your local distributor or MH
Reagent problem.
Lab.
1) Turn off o switch of
cooling, slowly turns the parts
problems and observe if there is noise
abnormal or if you are stuck.
Communication error. 2) Enter the interface of the 'parameter of
2) Mechanical parts are system", and select "Configuration of
Abnormal movement loose or tied. Engineer to adjust parameter.
10 Socket articulation (Accessible only to a professional)
the engine
the engine light is loose. authorized by MH Lab).
The light socket is with 3) Check the light socket and the
defect. replace if necessary.
4) If the problem still persists,
contact your local distributor or MH
Lab.

71
SN SYMPTOM PROBABLE CAUSE REPAIR
1) The motor of the blender Replace the blender motor.
Reinstall the mixer motor.
11 The mixer does notis broken.
Poor circuit connection 3) If the problem persists,
it works.
contact your local distributor or MH
from the mixer.
Lab.
Check the flow path tube.
Reconnect or replace the tube if it is
Pathway tube of necessary.
the flow has a leak. 2) Check the magnetic valve and the
Water leak from
12 wiper nozzles 2) Problem with the valve replace if necessary.
magnetic. 3) Check the vacuum pump and to
of the bucket.
3) Problema na bomba de replace if necessary.
vacuum. 4) If the problem still persists,
contact your local distributor or MH
Lab.
1) Check the flow path tube.
Reconnect or replace the tube if it is
Path tube of necessary.
The drops of water the flow has a leak. 2) Check the magnetic valve and the
Problem
13 will adhere to the tip of the
in the valve replace if necessary.
magnetic. Check the exterior of the probe. Clean it.
probe. The exterior of the probe is or replace the probe if necessary.
dirty or worn out. 4) If the problem still persists,
contact your local distributor or MH
Lab.

Check the reagent tray

it is completely prohibited.
2) Check if the device of
heat dissipation works
normally.
The cooling system Check if the sodas are
A tray is failing or the exhausted.
14 reagent cannot temperature of 4) Check if the circulation system
to be cold. cooling is not low does the cooling device work
sufficient. normally.
5) Replace the peltier.
6) If the problem persists,
contact your local distributor or MH
Lab.

72
SN SYMPTOM PROBABLE CAUSE REPAIR
1) Entre na interface de "Parâmetro
1) The parameters of from System
instrument they are"Engineer" to adjust the parameter.
configured in a way (Accessible only to professionals)
inadequate. authorized by MH Lab.
Human Inattention, 2) Read the Operation Manual and avoid
A probe e o como a tampa de frasco de human error.
15 mixer they arereagent has not been opened. 3) DO NOT place strange objects in
in conflict with Strange objects have been operation panel.
the other. placed on the panel of 4) Check if the engine is installed and
operation. it works correctly.
4) Engine Problem. 5) Check the light socket and the
Error in the socket of replace if necessary.
6) If the problem still persists,
lamp
contact your local distributor or MH
Lab.

73
 Chapter 9 - Storage and Transport

9.1 Storage
The packaged instrument should be stored in a ventilated area, with variation of
temperature between -40 to 55, and ambient humidity not exceeding 95%. DO NOT store the
instrument stored with poisons or corrosives. The instrument stored for more than a year
it may lose measurement accuracy. Therefore, it is recommended to carry out the procedures of
mechanical calibration and alignment when using the instrument.

The device stored for more than a year may not have an accurate measurement.
It is therefore suggested to carry out a calibration and mechanical alignment procedure.
when using the device. Please contact MH Lab to perform the
calibration for the device's mechanism.

9.2 Transport
The transportation must strictly follow the terms and conditions specified in the contract.
of the order.

Do not dispatch the instrument along with any poisons or corrosives.

Transport conditions: Temperature: -40 55 ; Relative Humidity 85%

74
 Appendix A–Replaceable Component

SN Name Observation
1 Fuse T8AL 250V
2 Reaction Bucket
3 Reaction Bucket Shelf
4 Light Source Lamp 12V 20W
5 Teflon tube φ1×2mm
6 PU Tube φ4×6mm, φ2×3mm, φ8×10mm
7 Probes
8 Stepped motor
9 Vacuum Pump
10 Solenoid Valve
11 Temperature controller
12 Temperature sensor
13 Cooling fan

NOTE:
Please use the reserve component provided by MH Lab. Replace
the components with service professionals authorized by the MH
Lab. MH Lab is not responsible for any consequences.
resulting from the use of parts or accessories not specified by
they.

NOTE:
This list of replaceable components is for reference only. The MH
Lab reserves the right to change it without prior notice.