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TDS IntelliVue X3 Patient Monitor RelM0indd

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0% found this document useful (0 votes)
345 views24 pages

TDS IntelliVue X3 Patient Monitor RelM0indd

Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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IntelliVue

Content
X3
Secondary content
Multi-Measurement
Module and
Patient Monitor

Monitoring on the move


Philips 867030 technical data sheet

The IntelliVue X3 is a compact, versatile, and portable patient respiration, SpO2, NBP, two invasive pressures, temperature,
monitoring device with a color touchscreen display. The and CO2.
state-of-the-art display with its modern multi-touch screen
The X3 can be used with adult, pediatric, and neonatal
allows easy interaction by sliding and tapping with one or two
patients in a hospital environment and during patient
fingers - smartphone style.
transport inside hospitals. The monitor stores data in trend
Chemically resistant housing together with Antimicrobial databases. You can see tabular trends (vital signs) and
Corning® Gorilla® Glass designed for improved damage document them on a printer connected to a central station
resistance, make the X3 a robust monitor designed to or a host monitor. You can view measurement trend graphs,
withstand challenges associated with in-hospital mobile including horizon trends, to help you identify changes in the
monitoring. patient’s physiological condition.
Full integration into the IntelliVue patient monitoring solution The monitor can operate using battery power for over five
helps providing best possible care for patients across all levels hours with basic monitoring configuration (see page 8) to
of acuity and supports institution-wide standardization. A let you reliably monitor patients during in-hospital transfer.
dual-purpose patient monitor, the X3 can be used as:
The X3 is powered from one of the following sources:
• A multi-measurement module for the IntelliVue family of
• A user-exchangeable rechargeable battery.
patient monitors.
• A host monitor, for example, an MX500 connected to the X3.
• A stand-alone patient/transport monitor.
• AC mains using the optional docking solution IntelliVue Dock1
By automatically turning from a multi-measurement module (867043), or the external power supply (M8023A).
into a fully functional transport monitor, without the need
During in-hospital transport the measurement extensions
for changing cables on the patient, the X3 supports the
(867039, 867040, and 867041) are powered by the X3, without
streamlining of clinical workflows and reduces transport
requiring the use of the IntelliVue Battery Extension (865297).
preparation time.
The X3 can simultaneously monitor ECG (using 3-, 5-, 6-,
or 10-lead sets, including arrhythmia and ST monitoring),
1. Not available for sale in the U.S.
Measurement Features • Ergonomic carrying handle. (optional).
• User exchangeable battery.
• Compact, rugged, lightweight monitor with a comprehensive
set of built-in clinical measurements.
Indications for Use
• ECG monitoring using any combination of 3 to 10 electrodes.
• 12-lead ECG monitoring with five electrodes using the EASI The monitor is indicated for use by health care professionals
placement method, with six electrodes using the Hexad whenever there is a need for monitoring the physiological
placement method, or with 10 electrodes using conventional parameters of patients.
electrode placement.
The monitor is intended to be used for monitoring and
• Multi-lead arrhythmia, and ST segment analysis at the
recording of, and to generate alarms for, multiple physiological
bedside on all available leads.
parameters of adults, pediatrics, and neonates. The monitor
• Mainstream/sidestream CO2
is intended for use by trained health care professionals in a
• Second Philips FAST SpO21 for Dual SpO2 applications
hospital environment.
• Dual2 invasive pressure, and a temperature measurement.
• Choice of Philips FAST SpO2, Nellcor3 OxiMax SpO2, Masimo4 The monitor is also intended for use during patient transport
rainbow SET SpO2. inside the hospital environment.
• With the Masimo rainbow SET technology, the measurement
The monitor is only for use on one patient at a time. It is not
device has options to monitor SpCO, SpMet, SpHb/SpOC,
intended for home use. Not a therapeutic device. The monitor
PVI, and rainbow acoustic (RRac) measurements.
is for prescription use only.
• IntelliVue XDS Database, enables the collection and storage
of vital signs information (numeric data only - no waves), Rx only: U.S. Federal Law restricts this device to sale by or on
for example, heart rate, pressure, ... on an external SQL the order of a physician).
database.
The ECG measurement is intended to be used for diagnostic
recording of rhythm and detailed morphology of complex
Usability Features
cardiac complexes (according to AAMI EC 11).
• Capacitive multi-touch screen as input device.
ST segment monitoring is intended for use with adult patients
• Intuitive smartphone-style operation.
only and is not clinically validated for use with neonatal and
• 6.1 inch state-of-the-art TFT flat-panel-display with 1024
pediatric patients.
x 480 resolution, wide viewing angle, large numerics,
permanently visible alarm limits5, and up to five real-time The Integrated Pulmonary Index (IPI) is intended for use with
waves. adult and pediatric (1 to 12 years) patients only. The IPI is an
• Ambient Light Sensor for optimal backlight brightness. adjunct to and not intended to replace vital sign monitoring.
• Multiple screen layouts to adapt to various clinical scenarios.
The derived measurement Pulse Pressure Variation (PPV)6 is
• Screen layouts are easily adjustable, allowing flexible display
intended for use with sedated patients receiving controlled
of measurement information.
mechanical ventilation and mainly free from arrhythmia. The
• The monitor can be used in either the vertical or horizontal
PPV measurement has been validated only for adult patients.
position, the display adapts to the orientation.
• Simple menu hierarchy and customizable SmartKeys provide
Hospital Environment
fast access to all primary monitoring tasks.
• Temperature, height, and weight can be configured either The monitor is suitable for use in all medically used
in metric or imperial units. Pressure measurements can be rooms which fulfill the requirements regarding electrical
displayed in kPa or mmHg. Gases can be displayed in kPa, installation according to IEC 60364-7-710 “Requirements
and mmHg. for special installations or locations - Medical locations”, or
• Patient data management with tabular and graphic trends. corresponding local regulations.
• Settings “Profiles” for rapid case turnover.
• Patented “AutoLimits” help caregivers to manage alarms Main Components
more effectively.
• Timers application lets you define and set clinical timers to Monitor
notify you when a specific time period has expired.
The monitor has a color TFT display with a wide viewing angle,
• Capable of functioning in a wireless infrastructure
providing high-resolution waveform and data presentation.
(SmartHopping - 1.4 GHz, or WLAN).
The display, processing unit, and measurements are integrated
• Additional independent display capability using IntelliVue
into one device.
XDS Remote Display.
• Bedside information access using the IntelliVue XDS Clinical
User Interface
Workstation.
The color Graphical-User-Interface is designed for fast and
intuitive operation, and ensures that clinicians quickly feel at
1. Only available with Philips FAST SpO2 ease using the monitor.
• Configurable SmartKeys with intuitive icons allow monitoring
2. Enabling dual pressure capability requires the use of a dual pressure
tasks to be performed quickly and easily, directly on the
cable or dual pressure adapter. See "Invasive Pressure Accessories" on
monitor screen.
page 23 for related options.
• Waves and numerics are color-coded, colors are
3.The following are trademarks and registered trademarks of a customizable.
Medtronic company: Nellcor, OxiMax. • The monitor displays up to five waves simultaneously. For
12-lead ECG monitoring, it can display 12 real-time ECG
4.The following are trademarks and registered trademarks of the Masimo
Corporation: Masimo, SET, rainbow, rainbow acoustic.

5. Dependent on screen layout. 6. Not available for sale in the U.S.

2
waves, with a rhythm strip and all ST values. Measurement Extensions
• Flexible screen layout allows you to quickly adapt to
• The 867039 Hemodynamic extension: adds temperature,
different clinical scenarios, for example, from your standard
two pressures, and optionally cardiac output/PiCCO to the
monitoring screen, to for example, to a Big Numerics screen,
X3.
or to 12-lead monitoring to acquire a diagnostic 12-lead ECG.
• The 867040 Capnography extension: adds mainstream/
• Change to a different screen layout by simply swiping - with
sidestream capnography, and optionally temperature, two
two fingers - across the screen.
pressures, and cardiac output/PiCCO to the X3.
• The Basic Help provides on-screen operating help,
• The 867041 Microstream1 extension: adds Microstream CO2,
explaining INOP and alarm messages.
and optionally temperature, two pressures, and cardiac
• Screen content automatically adjusts to the monitor
output/PiCCO to the X3.
orientation.
• The M3012A Hemodynamic extension: adds temperature,
pressure, an additional pressure or a temperature and
optionally cardiac output/PiCCO to the X3.
• The M3014A Capnography extension: adds mainstream and
sidestream capnography, and optionally one pressure plus
either a pressure or a temperature and cardiac output/PiCCO
to the X3.
• The M3015A Microstream CO2 extension: adds Microstream
CO2, and optionally either pressure or temperature to the X3.
• The M3015B Microstream CO2 extension: adds Microstream
CO2, and optionally two pressures and a temperature to the
X3.
Measurements from the M3012A, M3014A, and M3015A/B
measurement extensions are only available when the
extension is connected to an X3, and this is running on
• Usability evaluated through usability study conducted by an
external power. This is the case when the X3 is connected to:
independent human factors consulting group.
• An IntelliVue Dock (867043)2.
• The External Power Supply (M8023A).
Touchscreen
• The IntelliVue Battery Extension (865297).
The monitor is supplied with a capacitive multi-touch screen.
Touch a screen element to get to the actions linked to that Applications for Specific Care Settings
element, for example, touch a measurement numeric and
the setup menu for that measurement opens. Touch a wave Critical and Cardiac Care Features
to enter the setup menu for that wave. To scroll through lists
• The monitor performs multi-lead arrhythmia analysis on
and menus you can “swipe” over the screen, similar to using
the patient’s ECG waveform at the bedside. It analyzes for
a smartphone. The touchscreen supports the use of medical
ventricular arrhythmias, calculates heart rate, and generates
gloves.
alarms, including asystole, bradycardia, ventricular and atrial
fibrillation.
Simulated Keyboard
• Up to 12 leads of ST segment analysis can be performed
If alpha or numeric data entry is required, for example to on adult patients at the bedside, measuring ST segment
enter patient demographics, an on-screen keyboard will elevation and depression, and generating alarms and events.
automatically appear on the screen. The user can trend ST changes, set high and low alarm limits,
and set both ST and isoelectric measurement points. ST
Mounting points can be set either relative to the J-point or directly by
selecting a numeric value. Using ST Snippets, one-second
The mounting options available enable flexible, space saving
wave segments can be compared with a baseline segment
placement of the monitor for an ergonomic work space.
for each measured ST lead. The monitor also offers
• Bedhanger Mount - ideally suited for mounting the IntelliVue
independent ST Elevation (STE) analysis and alarming using
X3 during in-hospital patient transport. When mounted the
automated ISO and J-point determination and measuring
monitor is facing upwards to support direct access to the
the ST segment directly at the J-point (J +0). This is based on
monitor screen.
the recommendations for measuring ST Elevation published
• Fix Clamp Mount - ideally suited for mounting the
by the American Heart Association, the American College of
IntelliVue X3 for stationary use to, for example, an IV pole or
Cardiology and the European Society of Cardiology.
wall-mounted rail.
• QT/QTc interval monitoring provides the measured QT
• Rotatable Quick Claw Mount - ideally suited for mounting
interval, the calculated heart-rate corrected QTc value, and
the IntelliVue X3 during or following in-hospital patient
a ∆QTc value, which tracks variation in the QT interval in
transport. Enables quick release and supports the rotation of
relation to a baseline value.
the mounted monitor.
• ST Map application shows ST changes over time in two
multi-axis spider diagrams.
Extending Measurements
• STE Map adds gender-specific STE (ST Elevation) limits to ST
The X3 is compatible with Philips measurement extensions. Map. ST values violating these limits are indicated in red.
The extensions allow you to add specific measurements • Optional 12-lead ECG data can be measured in diagnostic
to those already integrated into the X3. The measurement
extensions connect to the X3 and use the X3 settings. Trend
data and measurement settings from the measurements in the 1. Microstream is a registered trademark of a Medtronic company.
extensions are stored in the X3.
2. Not available for sale in the U.S.

3
quality using conventional electrode placement with 10 disconnect the monitor for transport and reconnect to the
electrodes. Alternatively it can be measured using the mount after transport.
EASI lead system with five electrodes in EASI placement, • The universal admission/discharge/transfer (ADT) feature
or the Hexad lead system with six electrodes in standard means that all ADT information is shared between the
placement1. networked monitor and the Information Center. Information
• 12 realtime ECG waveforms can be displayed simultaneously. need only be entered once.
Diagnostic 12-lead ECG can be captured, reviewed, and • The monitor can operate using battery power for over
stored on the patient monitor before it is sent to the five hours - in a basic monitoring configuration (see
Information Center. Local printout is available, in harmonized page 8) - to let you reliably monitor patients during
layout. procedures or in-hospital transfers.
• High-performance pulse oximetry technologies perform • The IntelliVue Battery Extension (865297) extends the
accurately even in cases with low perfusion. battery runtime to up to 15 hours.
• Choice of sidestream or mainstream CO2 monitoring • During in-hospital transport the monitor powers the
for high-quality measurements with intubated and measurement extensions (867039, 867040, and 867041)
non-intubated patients without requiring the use of the battery extension. For the
• Integrated Pulmonary Index (IPI) enables clinicians to quickly measurement extensions M3012, M3014, M3015A, and
and easily assess a patient’s ventilatory status and monitor M3015B, the battery extension is required.
changes in a patient’s condition, facilitating more timely • Enhanced ruggedness due to:
interventions. - Ruggedized structural design
• Pulse Pressure Variation (PPV)2 is calculated from - Deploying chemically resistant housing materials designed
beat-to-beat arterial pressure values. Pulse pressure is the to resist deterioration from cleaning and disinfection agents
difference between the systolic and the diastolic pressure - Antimicrobial Corning® Gorilla® Glass3
values for a single beat. Pulse pressure variation is defined as - Improved ingress protection.
the maximal pressure less the minimum pressure divided by
the average of these two pressures. Patient Data Documentation
• An extensive range of Patient Reports can be printed:
Trends
- 12-lead ECG Reports
Trends are patient data collected over time and displayed - Alarm Limit Reports
in graphic, tabular or histogram form to give you a picture of - Vital Signs
how your patient’s condition is developing. Trend information - Graphic Trends
is stored in the trends database for continuously-monitored - Realtime Wave Reports
measurements, such as ECG, as well as for aperiodically • Report templates can be defined in advance, enabling
measured parameters, such as noninvasive blood pressure. print-outs tailored to each hospital’s specific requirements
• The Trends database stores patient data from up to to be started quickly. Reports can be printed on a printer
50 individual measurement parameters. The measurement connected to a central station, or via the IntelliVue XDS
information can be sampled every 12 seconds, 1 minute, or 5 Printing Service, and they can be initiated manually or
minutes, and stored for a period ranging from 4 to 48 hours. automatically at user-defined intervals.
- Each NBP measurement generates a column in the Vital • The IntelliVue XDS Printing Service allows printing of reports,
Signs trend table. The values for the other measurements waveform captures, and trends from the monitor to an
are added to provide a complete vital signs set for the NBP off-the-shelf printer or to an electronic file.
measurement time.
• Horizon Trends provide a graphical representation of Viewing Reports on the Host Monitor
changes to a patient’s measurements to make information
All reports stored in the print database of the X3, can be
clearer at a glance.
reviewed on the host monitor (with the appropriate monitor
option). Most reports will be displayed as a full-page report, in
Transport Features
the same format as they are printed out. Only electronic strip
Combining its role as multi-measurement module with that of reports are displayed differently - in the form of a recording
stand-alone monitor, the X3 is particularly suited to transport strip. The electronic strip report opens with the section of the
situations. When the X3 is disconnected from the host monitor, wave from the time the report was triggered. You can scroll to
it continues to monitor the patient as a stand-alone monitor see the rest of the strip. When an electronic strip is printed out,
running on battery power, eliminating the need for a separate it will be in the standard page format. When the X3 is used in
transport monitor. When the X3 is reconnected to a host companion mode, that is, connected to a host monitor, the
monitor, it resumes its role as multi-measurement module, strips can be reviewed on, and printed from the host monitor.
uploading trend data, patient demographic information and
measurement settings, supporting a gap free medical record. Alarms
• The compact portable design offers seamless in-hospital
The alarm system can be configured to present either the
transport across all levels of patient monitoring, simply
traditional HP/Agilent/Philips alarm sounds or sounds
unplug and go.
compliant with the IEC 60601-1-8 Standard.
• Specially-designed mounting solutions let you quickly
Dependent on the screen layout, alarm limits are permanently
visible on the main screen. When an alarm limit is exceeded, it
1. EASI/Hexad-derived 12-lead ECGs and their measurements are
is signaled by the monitor in the following ways:
approximations to conventional 12-lead ECGs. As the 12-lead ECG
derived with EASI/Hexad is not exactly identical to the 12-lead
conventional ECG obtained from an electrocardiograph, it should not
3. Refer to the Product Information Sheet: https://www.corning.com/
be used for diagnostic purposes.
content/dam/corning/microsites/csm/gorillaglass/PI_Sheets/CGG_
2. Not available for sale in the U.S. PI_Sheet_Anitimicrobia_Gorilla_Glass.pdf

4
• An alarm tone sounds, graded according to severity. Networking Capabilities
• An alarm message is shown on the screen, color-coded
according to severity. Network Interface
• The numeric of the alarming measurement flashes on the
The network interface provides the system with networking
screen.
capability via a wired connection (LAN) when connected
• Alarm lamps flash for red and yellow alarms and are
to the 867043 IntelliVue Dock (option E50), or the M8023A
illuminated for technical INOPs.
external power supply (optionE27), or via a wireless network
The alarm-limit review page offers an overview of alarm limit connection as described below.
settings and the possibility to modify these settings for all
parameters. Wireless Network
A ‘Smart Alarm Delay’ feature helps to reduce the number of The monitor can function within a wireless infrastructure based
pulse-oximetry nuisance alarms. on an IEEE 802.11a/b/g/n network in the 2.4 GHz / 5 GHz
bands (ISM). Also, the monitor can function within a telemetry
If the monitor is connected via a network to a central
infrastructure compatible with the Philips Cellular Telemetry
monitoring station, alarming is simultaneous at the monitor
System (CTS) in the WMTS1 band.
and at the Information Center.
Additional components are required to complete the system.
Alarms are graded and prioritized according to severity:
Refer to the M3185A IntelliVue Clinical Network Technical Data
- Red Alarms*** identify a potentially life-threatening
Sheet for further information.
situation for a patient.
- Yellow Alarms** indicate conditions violating preset
Optional Networking Capabilities
vital-signs limits.
- Yellow Alarms* indicate arrhythmia alarms. The monitor can operate as part of a networked system
- Technical Alarms (INOPs) are triggered by signal quality (wired/ wireless) using the Philips IntelliVue Clinical Network
problems, equipment malfunction, or equipment interface.
disconnect.
This includes:
• The Silence function allows you to switch off alarm tones
• DHCP/BootP
with one touch while retaining visual alarm messages.
• QoS Tagging
• Holding the Silence button opens a window which lets
• WMM on wireless networks.
you pause alarms. All alarms can be paused indefinitely, or
• 802.11 WLAN, or Smart Hopping Interface (1.4 GHz - USA
for one, two, three, five, or 10 minutes depending on their
only)
configuration.
• Electronic strip recording allows alarm-triggered and
Device Connections
manually started electronic strips to be captured in the
monitor database and printed in the form of reports when a The monitor can be connected to:
printer is available. The strips can be sent to an Information • Measurement extensions2 (867039, 867040, 867041).
Center or to the XDS Printing Service that is part of the • Measurement extensions3, (M3012A, M3014A, M3015A/B).
IntelliVue XDS Application. The reports can then be printed • A compatible host monitor of the IntelliVue family4.
to a standard off-the-shelf printer and can also be stored • An IntelliVue Dock (867043)5.
as files on the Information Center or the PC hosting the XDS • An external power supply (M8023A)
Printing Service. For printing the X3 must be connected to a • IntelliVue Battery Extension (865297).
host monitor, an M8023A external power supply, or a 867043 • A Central Station/ Information Center (for example, PIC iX).
IntelliVue Dock. • A PC running the IntelliVue XDS Solution.
• Patented “AutoLimits” help caregivers to manage alarms
more effectively, automatically adapting the alarm limits Compatibility
to the patient’s currently measured vital signs within a safe
Compatible host monitors for the X3 are:
margin defined individually for each patient.
- IntelliVue MP20/30, MP40/50, MP60/70, MP80/90
• Visual and/or audible latching and non-latching alarm
- IntelliVue MX400, MX430, MX450, MX500, MX550,
handling is available.
MX600, MX700, MX800, XG50
Profiles
Service Features
Profiles are predefined configuration settings for screens,
measurement settings, and monitor properties. Each A password-protected service mode ensures that only trained
Profile can be designed for a specific application area and staff can access service tests and tasks.
patient category, for example OR adult, or ICU neonatal.
Profiles enable a quick reaction to patient and care location
changes: activating a Profile with a particular patient category
(adult, pediatric, or neonatal) automatically applies suitable 1. USA only.
alarm and safety limits and saves time usually spent carrying
2. The measurement extensions 867039, 867040, and 867041 are
out a complete set-up procedure.
powered from the X3 internal battery during transport.
A selection of Profiles for common monitoring situations is
3.The measurement extensions M3012A, M3014A, and M3015A/B will
provided with the monitor. Profiles can also be created directly
only function when they are connected to the IntelliVue Battery
on the monitor or remotely on a PC and transferred to the
Extension, or the monitor is connected to either an external power
monitor using the IntelliVue Support Tool.
supply or a host monitor.

4. The host monitor requires software M.0 or higher.

5. Not available for sale in the U.S.

5
A password-protected configuration mode allows trained Physical Specifications
users to customize the monitor configuration.

Upgradability
Product Max. Weight WxHxD
The monitor allows new capabilities to be added in the future
as your monitoring requirements evolve. This upgradability IntelliVue X3 1.4 kg (3.1 lb) Without handle:
gives the security of knowing that the monitors can be (incl. options, 194 x 97 x 85 mm
enhanced and updated as practices and technologies battery pack (7.6 x 3.8 x 3.3 in)
advance, and it protects long-term investments. and handle)
With handle:
IntelliVue Support Tool 249 x 97 x 111 mm
(9.8 x 3.8 x 4.4 in)
The IntelliVue Support Tool helps technical personnel to:
• Carry out configuration, upgrades, and troubleshooting via
the network, or on an individual monitor
• Share configuration settings between monitors
• Back up the monitor settings Environmental Specifications
Care and Cleaning
Item Condition Range
The X3 deploys chemically-resistant surface materials,
Temperature range Operating 0–40°C (32–104°F)
designed to resist deterioration from cleaning and disinfection
Or, 0–35°C (32–95°F)
agents. Even against very aggressive disinfectants, the X3's
- when charging the
housing materials have been tested, and found to resist
battery, or
deterioration about 60 times longer than the housing material
- when using a Smart
used for its predecessor. Refer to the list of tested agents in
Hopping Interface or
the monitor's Instructions for Use.
WLAN, or
- when mounted on the
Monitor Specifications back of a host monitor.

For measurement extensions, see the respective Data Sheets.


Storage -20–60°C (-4–140°F)
Safety Specifications
Humidity range Operating 15–95% RH
The monitor complies with the Medical Device Directive
non-condensing
93/42/EEC and, among other standards, with:
• IEC 60601-1, Ed.3.1:2012-08 (cons.)
Storage 5–90% RH
• EN 60601-1:2006 + AC:2010 + A1:2013, Ed.3
non-condensing
• ANSI/AAMI ES60601-1:2005/(R)2012, Ed.3 (cons.)
• CAN/CSA-C22.2 No. 60601-1:14, Ed.3 (cons.)
Altitude range Operating -500–3000 m
• IEC 60601-1-2:2007, Ed.3
(-1640–9842 ft)
• EN 60601-1-2:2007 + AC:2010, Ed.3
• IEC 60601-1-2:2014, Ed.4
Storage -500–4600 m
• EN 60601-1-2:2015, Ed.4
(-1640–15091 ft)
• IEC 60601-1-6:2010 + A1:2013
• EN 60601-1-6:2010
Ingress protection Monitor IP32 (when in the
• IEC 60601-1-8:2006 + A1:2012
horizontal position)
• EN 60601-1-8:2007 + A1:2013
• IEC 60601-2-49:2011
External • M8023A:
• EN 60601-2-49:2015
Power Supply - IP31 when rested on its
All applied parts are Type CF unless otherwise specified. (M8023A, or rubber feet on a flat,
They are protected against damage from defibrillation and 867043) level surface.
electrosurgery. - IP32 when mounted
with the connectors
The possibility of hazards arising from software errors was
facing downwards.
minimized in compliance with:
• 867043: IP32
• ISO 14971:2007
• EN ISO 14971:2012
• ANSI/AAMI ISO 14971:2010 Performance Specifications
• IEC 62304:2006
• EN 62304:2006 +AC:2008 X3 patient monitor
This ISM device complies with Canadian ICES-001. Cet
appareil ISM est conforme à la norme NMB-001 du Canada.
Power
Power consumption • <12 W average
• <20 W when on IntelliVue
Dock

6
Power Alarm Signal
System delay <4 seconds.
Operating voltage 36–60 V dc floating
The system alarm delay is the
processing time the system
Current 1.3–0.7 A
requires for any alarm to be
indicated on the monitor, after
Frequency 50/60 Hz
the measurement has triggered
the alarm.
Display
Delay for alarm availability on <5 seconds
Active matrix color LCD display with capacitive multi-touch the network This is the time required after
screen an alarm indication on the
monitor, until the alarm signal
Sweep speeds 6.25, 12.5, 25, and 50 mm/s is available on the network, to
the Patient Information Center,
Resolution 1024 x 480 or for transmission to other
systems.
Useful screen 140 x 65 mm (5.5 x 2.6 in)
Pause duration 1, 2, 3 minutes or infinite,
Pixel pitch 0.14 x 0.14 depending on configuration

Extended alarm pause 5 or 10 minutes


Indicators
Sound pressure range Minimum 0 dB(A)
Alarms off Red or yellow LED with
Maximum 45–85 dB(A)
crossed out alarms symbol

Alarms Red/yellow/light blue (cyan)


Review Alarms
LED
Information All alarms / INOPs, main
On/Standby/Error Green/red LED integrated in alarms on /off, alarm silence,
power switch and time of occurrence

External power Green LED Capacity 300 items

Battery Green (full), yellow (charging),


red blinking (empty) LED Real Time Clock
Range From: January 1, 1997, 00:00
to: December 31, 2080, 23:59
Sounds
• Audible feedback for user input Accuracy Better than 4 seconds per day

• Prompt tone Hold Time when switched off • If powered by AC: Infinite
• With battery: time is stored
• QRS tone, or SpO2 modulation tone but a hold time is not
specified, as storing a battery
• Four different alarm sounds in an unused device for a
longer period of time is not
recommended.
Display Wave Speeds • Without power or battery at
least 48 hours.
Available for standard waves 6.25 mm/s, 12.5 mm/s,
25 mm/s, 50 mm/s with ±5%
accuracy (guaranteed only for
Buffered Memory
integrated displays)
Contents Active settings, trends, patient
data, realtime reports, events,
Trends review alarms
Resolution 12 or 16 numerics @
12 seconds, 1 minute, 5 minute
resolution.

Information Multiple choices of number


of numerics, resolution, and
duration depending on trend
option and application area.

7
External Power Supply M8023A Performance Specifications
Buffered Memory
Hold Time when switched off • Infinite If powered by AC.
Power
• With battery memory is
buffered but a hold time is Power consumption • <12 W average
not specified, as storing a • <30 W peak
battery in an unused device
for a longer period of time is Line voltage 100–240 V ∼
not recommended.
• Without power: at least Current 1.3–0.7 A
4 hours
Frequency 50/60 Hz ∼

Internal Battery (453564526811)


The battery is required for the operation of the monitor. The
battery lifetime is 3 years from manufacturing date or 500 Indicators
charge/discharge cycles. AC power Green LED
Operating time (with a new, Basic Mode 1: >5 hours.
fully charged battery at 25°C) • ECG/Resp
• FAST SpO2
• NBP every 15 minutes
• Brightness (auto mode off)
Interface Specifications
set to optimum (4)
X3 patient monitor
• Extended Mode 2: >3 hours.
• ECG/Resp
• FAST SpO2
Measurement Link (MSL)
• Dual Pressure
• Temperature Connectors Female MSL (proprietary)
• NBP every 15 minutes
• CO2 Power 36–60 V input
• Wireless radio
• Brightness (auto mode off) Power sync Unused
set to optimum (4)
LAN signals IEEE 802.3 10Base-T and
Charge time • When monitor is off: 3 hours 100Base-TX compliant
approx.
• When monitor is in use and Serial signals RS-422 compliant
connected to an IntelliVue
Dock, without measurement Local signals Provided for connecting
extensions: 2.5 hours approx. measurement extensions
• When monitor is in use and
connected to the external Local voltage 9–12.3 V - provided to power
power supply (M8023A) the measurement extensions:
without measurement 867039, 867040, and 867041
extensions: 4 hours approx.

Restart Time
Smart Hopping IF 1.4 GHz (USA only)
After a power interruption, an
ECG wave will be shown on
Type Internal WMTS adapter
the display after a maximum of
30 seconds.
Technology Compatible with Philips
Cellular Telemetry System
(CTS), cellular infrastructure

Frequency band WMTS, 1395–1400 MHz and


1427–1432 MHz

Modulation technique GFSK

Effective isotropically Below 22 dBm (164 mW)


radiated power (EIRP)

8
802.11 Wireless IF (Wireless Network Adapter) Performance Specifications

Nominal voltage 10.8 V


Type Internal wireless adapter
Rated capacity at discharge 2000 mAh (typically)
Technology IEEE 802.11a/b/g/n
C/5
Frequency band 2.4 GHz and 5 GHz ISM
Continuous discharge 4A
capability
USA • 2.400–2.483 GHz
• 5.15–5.35 GHz
• 5.72–5.825 GHz
Environmental Specifications
Europe • 2.400–2.483 GHz
Temperature range • Discharge 0–60°C (32–140°F)
• 5.15–5.35 GHz,
• Charge 0–60°C (32–140°F)
• 5.470–5.725 GHz
• Storage and Transport:
-20–65°C (-4–149°F)
Japan • 2.400–2.483 GHz
• 5.15–5.25 GHz
Humidity range • Operating: 15–90% Relative
• 5.25–5.35 GHz
Humidity (RH)
• 5.470–5.725 GHz
• Storage and Transport:
5–95% Relative Humidity
China • 2.400–2.483 GHz
(RH)
• 5.725–5.85 GHz
Battery type Lithium-ion, 10.8 V, 2000 mAh
Modulation technique • DSSS (CCK, DQPSK, DBPSK)
802.11b/g/n • OFDM (BPSK, QPSK,
Safety Complies with:
16-QAM, 64-QAM)
UL 62133/IEC 62133
Modulation technique OFDM (BPSK, QPSK, 16-QAM,
Electromagnetic compatibility Complies with the
802.11a/n 64-QAM)
requirements for FCC
Type B computing device,
Bandwidth 20 MHz (nominal)
and EN 61000-4-2, and
EN 61000-4-3
Effective isotropically Below 20 dBm (100 mW)
radiated power (EIRP)
Communication standard Complies with the SMBus
specification v1.1

M8023A External Power Supply Interface Specifications


Measurement
Specifications
Measurement Link (MSL)
Connectors Male MSL (proprietary)
ECG/Arrhythmia/ST/QT
Complies with:
Power 48 V output • IEC 60601-2-25:2011
• ANSI/AAMI/IEC 60601-2-25:2012
Power sync. RS-422 compliant output • IEC 60601-2-27:2011
78.125 kHz (typical) • ANSI/AAMI/IEC 60601-2-27:2011 + Err:2012

LAN signals IEEE 802.3 10Base-T


compliant
ECG/Arrhythmia/ST Performance Specifications

Battery Specifications
Cardiotach
45364526811 Battery
Range • Adult/pedi: 15–300 bpm
• Neo: 15–350 bpm
Physical Specifications
Accuracy ±1% of range
WxHxD 69.6 x 72.3 x 21.6 mm
(2.7 x 2.8 x 0.8 mm) Resolution 1 bpm

Weight 0.2 kg (0.4 lb) Sensitivity 200 μVpeak

9
PVC Rate Bandwidth

Range 0–300 bpm Diagnostic mode Adult/neo/pedi: 0.05–150 Hz

Resolution 1 bpm Extended monitoring mode Neo/pedi: 0.5–150 Hz

Monitoring mode • Adult: 0.5–40 Hz


ST Numeric • Neo/pedi: 0.5–55 Hz

Range -20–20 mm Filter mode Adult/neo/pedi: 0.5–20 Hz

Accuracy ±0.5 mm or 15% whichever is


greater Bandwidth - when ECG is transmitted from a telemetry device
via a short-range radio
Resolution 0.1 mm
Diagnostic mode Adult/neo/pedi: 0.05–40 Hz

Extended monitoring mode Adult/neo/pedi: 0.5–40 Hz


QT Numeric
Monitoring mode • Adult: 0.5–40 Hz
Range 200–800 ms
• Neo/pedi: 0.5–40 Hz
Accuracy ±30 ms
Filter mode Adult/neo/pedi: 0.5–20 Hz
Resolution 8 ms
Differential Input Impedance
QTc Numeric
• >2 M RA-LL leads (Resp)
• >5 M at all other leads (at 10 Hz including patient cable)
Range 200–800 ms

Resolution 1 ms
Common Mode Rejection Ratio

• Diagnostic mode: >86 dB (with a 51 k/47 nF imbalance)


∆QTc Numeric
• Filter mode: >106 dB (with a 51 k/47 nF imbalance)
Range -600–600 ms
Electrode Offset Potential Tolerance
Resolution 1 ms
±500 mV
QT-HR Numeric
Auxiliary Current (Leads off Detection)
Range - Adult 15–150 bpm
• Active electrode: <100 nA
Range - Pedi/neo 15–180 bpm
• Reference electrode: <900 nA
Resolution 1 bpm
Input Signal range
Sinus and SV Rhythm Ranges
±5 mV
Brady • Adult: 15–59 bpm
• Pedi: 15–79 bpm ECG/Arrhythmia/ST Supplemental Information as required
• Neo: 15–89 bpm by IEC 60601-2-27

Normal • Adult: 60–100 bpm


• Pedi: 80–160 bpm Respiration Excitation Waveform
• Neo: 90–180 bpm
Sinusoidal signal, <260 μA @ 40.5 kHz
Tachy • Adult: >100 bpm
• Pedi: >160 bpm
Noise Suppression
• Neo: >180 bpm
RL drive gain 44 dB maximum, maximum voltage 1.8 Vrms

10
Time to Alarm for Tachycardia Pacemaker Pulse Rejection of Fast ECG Signals

Vent Tachycardia 1 mVpp, • Gain 0.5, Range 6.5–8.4 seconds, 2.2 V/s RTI (Paced Mode)
206 bpm Average 7.2 seconds
• Gain 1.0 Range 6.1–6.9 seconds,
Average 6.5 seconds Minimum Input Slew Rate
• Gain 2.0, Range 5.9–6.7 seconds,
Average 6.3 seconds 2.2 V/s RTI

Vent Tachycardia 2 mVpp, • Gain 0.5, Range 5.4–6.2 seconds,


ECG/Arrhythmia/ST Alarm Specifications
195 bpm Average 5.8 seconds
• Gain 1.0, Range 5.7–6.5 seconds,
Average 6.1 seconds
HR
• Gain 2.0, Range 5.3–6.1 seconds,
Average 5.7 seconds Range 15–300 bpm maximum delay:
10 seconds according to
IEC 60601-2-27
Tall T-Wave Rejection Capability
Adjustment Adult:
1.2 mV T-Wave amplitude according to IEC 60601-2-27, • 1 bpm steps (15–40 bpm)
clause 201.12.1.101.17. • 5 bpm steps (40–300 bpm)
Pedi/neo:
• 1 bpm steps (15–50 bpm)
Heart Rate Averaging Method • 5 bpm steps (50–300 bpm)

Three different methods are used:


• Normally, heart rate is computed by averaging the 12 most
recent RR intervals.
Extreme Tachy
• For runs of PVCs, up to eight RR intervals are averaged to
compute the HR.
Range • Difference to high limit 0–50 bpm
• If each of three consecutive RR intervals is >1200 ms (that
• Clamping at 150–300 bpm
is, rate <50 bpm), then the four most recent RR intervals are
averaged to compute the HR.
Adjustment • 5 bpm steps

Response Time of Heart Rate Meter to Change in Heart Rate


Extreme Brady
HR change from 80–120 bpm: • Range: 6.4–7.2 seconds
• Range • Difference to low limit 0–50 bpm
• Average: 6.8 seconds
• Clamping at 15–100 bpm
HR change from 80–40 bpm: • Range: 5.6–6.4 seconds
• Adjustment • 5 bpm steps
• Average: 6.0 seconds

Run PVCs
Heart Rate Meter Accuracy and Response to Irregular Rhythm
Range None, fixed setting of 2 PVCs
• Ventricular bigeminy: 80 bpm
• Slow alternating ventricular bigeminy: 60 bpm
Adjustment Not adjustable by user
• Rapid alternating ventricular bigeminy: 120 bpm
• Bidirectional systoles: 90 bpm
PVCs Rate
Accuracy of Input Signal Reproduction
Range 1–99 PVCs/minute
Methods A and D (according to IEC 60601-2-25, clause
Adjustment 1 PVC
201.12.4.107.1.1.1) were used to establish overall system error
and frequency response.
Vent Tach HR
Pacemaker Pulse Rejection Performance
Range 20–300 bpm
Rejection of pacemaker pulses with amplitudes from ±2 mV to
Adjustment 5 bpm
±700 mV and widths from 0.1 ms to 2.0 ms (Method B)

11
Respiration
Vent Tach Run
Respiration Performance Specifications
Range 3–99 PVCs/minute

Adjustment 1 PVC Respiration Rate


Range • Adult/pedi: 0–120 rpm
• Neo: 0–170 rpm
Vent Rhythm Run
Accuracy • At 0–120 rpm ±1 rpm
Range 3–99 PVCs/minute
• At 120–170 rpm ±2 rpm
Adjustment 1 PVC
Resolution 1 rpm

SVT HR

Range 120–300 bpm Bandwidth

Adjustment 5 bpm 0.3–2.5 Hz (-6 dB)

SVT Run
Noise
Range 3–99 SV beats
<25 m (rms) referred to the input
Adjustment 1 SV beat

Respiration Alarm Specifications


ST High

Range -19.8–20 mm High


Range • Adult/pedi: 10–100 rpm
Adjustment 0.2 mm
• Neo: 30–150 rpm

Adjustment • <20 rpm: 1 rpm steps


ST Low
• 20 rpm: 5 rpm steps
Range -20–19.8 mm
Delay Maximum 14 seconds
Adjustment 0.2 mm
Low
QTc High
Range • Adult/pedi: 0–95 rpm
• Neo: 0–145 rpm
Range 200–800 ms
Adjustment • <20 rpm: 1 rpm steps
Adjustment 10 ms steps
• 20 rpm: 5 rpm steps

Delay • For limits from 0 to 20 rpm:


∆QTc High
maximum 4 seconds
• For limits above 20 rpm: maximum
Range 30–200 ms
14 seconds
Adjustment 10 ms steps
Apnea Alarm

Range 10–40 seconds

Adjustment 5 second steps

12
FAST SpO2 (867030 #SP1)
With Nellcor Sensors with M1943A(L) adapter cable
Complies with:
• ISO 80601-2-61:2011
Accuracy 3% (70–100%) • MAXA
• EN ISO 80601-2-61:2011
• MAXAL
Measurement Validation • MAXP
• MAXI
The SpO2 accuracy has been validated in human studies
• MAXN
against arterial blood sample reference measured with a
• D-25
CO-oximeter. Pulse oximeter measurements are statistically
• D-20
distributed, only about two-thirds of the measurements can
• I-20
be expected to fall within the specified accuracy compared to
• N-25
CO-oximeter measurements.
• OxiCliqa A, P, I, N
The specified accuracy is the root-mean-square (RMS) a. requires additional Nellcor OC3
difference between the measured values and the reference adapter cable
values.

Philips FAST SpO2 Performance Specifications With Masimo Reusable Sensors with LNOP MP12 or LNC
MP10 adapter cable
Accuracy 2% (70–100%) • LNOP DCI
Range and Resolution
• LNOP DCIP
Range 0–100% • LNOP YI (Adult/pedi/infant)
• LNCS DCI
Resolution 1% • LNCS DCIP
• LNCS YI (Adult/pedi/infant)

With Philips Reusable Sensors Accuracy 3% (70–100%) • LNOP YI (Neonate)


• LNCS YI (Neonate)
Accuracy 2% (70–100%) • M1191A
• M1191AL Accuracy 3.5% (70–100%) • LNOP TC-I
• M1191B • LNCS TC-I
• M1191BL
• M1192A
With Masimo Disposable Sensors with LNOP MP12 or LNC
Accuracy 3% (70–100%) • M1193A MP10 adapter cable
• M1194A
Accuracy 2% (70–100%) • LNOP Adt
• M1195A
• LNOP Adtx
• M1196A/S
• LNOP Pdt
• LNOP Pdtx
• LNOP Inf-L
With Philips Reusable Sensors with M1943A(L) adapter cable
• LNOP Neo-L (Adult)
• LNCS Adtx
Accuracy 3% (70–100%) • M1191T
• LNCS Adtx-3
• M1192T
• LNCS Pdtx
• M1193T (Adult)
• LNCS Pdtx-3
• M1196T
• LNCS Inf
• LNCS Inf-3
Accuracy 4% (70–100%) • M1193T (Neonate)
• LNCS Neo (Adult)
• LNCS Neo-3 (Adult)
With Philips Disposable Sensors with M1943A(L) adapter
Accuracy 3% (70–100%) • LNOP Neo-L (Neonate)
cable
• LNOP NeoPt-L
Accuracy 2% (70–100%) • M1132A • LNCS Neo (Neonate)
• M1133A • LNCS Neo-3 (Neonate)
• M1134A (Adult/infant) • LNCS NeoPt
• LNCS NeoPt-3
Accuracy 3% (70–100%) • M1131A
• M1133A
• M1134A (Neonate) Pulse
• M1901B
• M1902B Range 30–300 bpm
• M1903B
• M1904B Accuracy 2% or 1 bpm, whichever is greater

Resolution 1 bpm

13
Sensors Sensors - with M1943NL adapter cable

Wavelength range 500–1000 nm Wavelength range b 500–1000 nm

Emitted light energy 15 mW Emitted light energy 15 mW

Numeric update rate Numeric update rate

Typical 1 second Typical 1 second

Maximum 30 seconds - Maximum with Maximum 60 seconds


noninvasive blood pressure INOP
suppression on: 60 seconds
a.
Specification applies to the performance of the device. Reading
accuracy in the presence of low perfusion (detected IR pulse
Pulse Oximeter Calibration Range modulation amplitude 0.03–1.5%) was validated using signals supplied
by a patient simulator. SpO2 and pulse rate values were varied across
70–100% the monitoring range over a range of weak signal conditions and
compared to the known true saturation and pulse rate of the input
signals.
Nellcor OxiMax SpO2 (867030 #SP6) b.
Information about the wavelength range can be especially useful to
Complies with: clinicians (for instance, when photodynamic therapy is performed).
• ISO 80601-2-61:2011
• EN ISO 80601-2-61:2011 Pulse Oximetry Accuracy Table
Measurement Validation
The SpO2 accuracy has been validated in human studies SaO2 Range: 70–100% SaO2 Range:
against arterial blood sample reference measured with a 60–80%
CO-oximeter. Pulse oximeter measurements are statistically
distributed, only about two-thirds of the measurements can
Sensor Adult/Infant Neonate Adult
be expected to fall within the specified accuracy compared to
CO-oximeter measurements. MAXA, MAXAL 2% n/a 3%
The specified accuracy is the root-mean-square (RMS)
MAXN a 2% 2% 3%
difference between the measured values and the reference
values.
MAXP 2% n/a 3%
Pulse Oximetry Performance Specifications
MAXI 2% n/a 3%

MAXFAST 2% n/a 3%
SpO2
Measurement range 1–100% MAXR b 3.5% n/a n/a

Resolution 1% SC-A 2% n/a n/a

Accuracy See the Pulse Oximetry Accuracy SC-PR c n/a 2% n/a


Table
SC-NEO c n/a 2% n/a
Low perfusion accuracy a 2% (70–100%)
OxiCliq A 2.5% n/a n/a

OxiCliq P 2.5% n/a n/a


Pulse
OxiCliq N d 2.5% 3.5% n/a
Range 25–300 bpm
OxiCliq I 2.5% n/a n/a
Resolution 1 bpm
D-YS d 3% 4% n/a
Accuracy ±3 bpm (20–250 bpm)
D-YS & D-YSE 3.5% n/a n/a
a
Low perfusion accuracy ±3 bpm (20–250 bpm)
D-YSPD 3.5% n/a n/a

DS100A 3% n/a n/a

14
SaO2 Range: 70–100% SaO2 Range: Pulse
60–80%
Range 30–300 bpm
Sensor Adult/Infant Neonate Adult
Adjustment Adult:
OXI-A/N d 3% 4% n/a • 1 bpm steps (30–40 bpm)
• 5 bpm steps (40–300 bpm)
OXI-P/I 3% n/a n/a Pedi/neo:
• 1 bpm steps (30–50 bpm)
M1901B a Identical to OxiMax MAXN • 5 bpm steps (50–300 bpm)

M1902B Identical to OxiMax MAXI Delay Maximum 14 seconds

M1903B Identical to OxiMax MAXP


Tachycardia
M1904B Identical to OxiMax MAXA
a.
Range • Difference to high limit: 0–50 bpm
M1901B/MAXN: Clinical functionality has been demonstrated on a
• Clamping at 150–300 bpm
population of hospitalized neonate patients. The observed SpO2
accuracy was 2.5% in a study of 42 patients with ages of 1 to 23 days,
Adjustment 5 bpm steps
weight from 750–4100 grams, and 63 observations made spanning a
range of 85–99% SaO2 while monitored with Nellcor OxiMax N-595
Delay Maximum 14 seconds
pulse oximeters.
b.
The accuracy specification has been determined between saturations
of 80–100%.
c.
SoftCare SC-PR-I, SC-NEO-I: Clinical functionality has been Bradycardia
demonstrated on a population of hospitalized neonate and infant
Range • Difference to low limit: 0–50 bpm
patients. The observed SpO2 accuracy was 3.0% in a study of
• Clamping at 30–100 bpm
57 patients with ages of 24 to 40 weeks, weight from 710–5000 grams,
and 185 observations made spanning a range of 63–100% SaO2 while
Adjustment 5 bpm steps
monitored with Nellcor OxiMax N-595 pulse oximeters.
d.
Neonatal accuracy: When sensors are used on neonatal subjects as
Delay Maximum 14 seconds
recommended, the specified accuracy range is increased by ±1 digit,
as compared to adult usage, to account for the theoretical effect on
oximeter measurements of fetal hemoglobin in neonatal blood. For
example, OxiCliq N accuracy on neonates is ±3.5 digits, rather than
Masimo rainbow SET SpO2
±2.5.
(867030 #SP5)
Alarm Specifications for Philips FAST Complies with:
• ISO 80601-2-61:2011
SpO2 and Nellcor OxiMax SpO2 • EN ISO 80601-2-61:2011

SpO2 General Performance Specifications SpO2

Range • Adult: 50–100% Numeric update rate for • Typical: 1 second


• Pedi/neo: 30–100% SpO2, Pulse Rate, and Perf• Maximum: 30 seconds

Adjustment 1% steps Sensors • Emitted Light Energy 25 mW


• Wavelength Range a 500–1400 nm
Delay 0–30 seconds (0, 1, 2, 3,... 30) a.
Information about wavelength range can be especially useful to
+ 4 seconds
clinicians (for instance when photodynamic therapy is performed).

Indications for Use


Desat
The Masimo rainbow SET measurement is indicated for the
Range • Adult: 50% to low alarm limit noninvasive monitoring of functional oxygen saturation of
• Pedi/neo: 30% to low alarm limit arterial hemoglobin (SpO2), pulse rate, carboxyhemoglobin
saturation (SpCO), methemoglobin saturation (SpMet), total
Adjustment 1% steps hemoglobin concentration (SpHb), and/or respiratory rate
(RRac). The Masimo rainbow SET measurement is indicated for
Delay 0–30 seconds (0, 1, 2, 3,... 30) use with adult, pediatric, and neonatal patients during both no
+ 4 seconds motion and motion conditions, and for patients who are well
or poorly perfused.

15
Operating Conditions
Measurement Accuracy
In addition to the general specifications for operating
conditions for the X3 portable patient monitor, the following
additional environmental limitations apply for the Masimo RRac 4–70 ±1 breath per minute,
rainbow SET measurement: Adult/pedi (>10 kg)

Environmental Limitations Measurement Range and Resolution

Incandescent Light Intensity 100 klx


SpO2
Fluorescent Light Intensity 10 klx
Range 0–100%
Fluorescent Light Frequency • 50 Hz or 60 Hz ±1.0 Hz
Resolution 1%
(LNOP, LNCS sensors)
• 50 Hz or 60 Hz ±0.5 Hz
(rainbow sensors)

Ambient Noise Level (Sound 65 dB, Alarm tolerant Perf


Pressure Level) (applies
to acoustic respiration Range • 0.02–20 for disposable sensors
measurement only) • 0.05–20 for reusable sensors

Resolution 0.01
Measurement Accuracy
The following accuracy specifications represent only
the device’s portion of the integrated Masimo rainbow PVI
SET technology performance. The actual measurement
performance and accuracy depends on the accessory used Range 0–100%
and can be limited by the accessory as specified in the
sensor’s Directions For Use. Resolution 1%
Ensure that you only use accessories that are specified and
provide accuracy specifications applicable for your device.
Pulse

Range 25–240 bpm


Measurement Accuracy
Resolution 1 bpm
SpO2, no motion • 60–80 ±3%, Adult/pedi/
infant
• 70–100 ±2%, Adult/pedi/ SpCO
infant, ±3% Neo
Range 0–100%

SpO2, motion 70–100 ±3%, Adult/pedi/ Resolution 1%


infant/neo

SpO2, low perfusion 70–100 ±2%, Adult/pedi/ SpMet


infant/neo
Range 0–100%
Pulse Rate, no motion 25–240 ±3 bpm, Adult/pedi/
infant/neo Resolution 0.1%

Pulse Rate, motion 25–240 ±5 bpm, Adult/pedi/


infant/neo SpHb

Pulse Rate, low perfusion 25–240 ±3 bpm, Adult/pedi/ Range 0–25 g/dl (0-15.5 mmol/l)
infant/neo
Resolution 0.1 g/dl (0.1 mmol/l)
SpCO 1–40 ±3%, Adults/pedi/infant

SpMet 1–15 ±1%, Adult/pedi/infant/ SpOC


neo
Range 0–35 ml/dl
SpHb 8–17 ±1 g/dl (arterial or
venous), Adult/pedi Resolution 1 ml/dl

16
RRac SpOC

Range 4–70 rpm Adjustment 1 ml/dl steps

Resolution 1 rpm Delay Maximum 4 seconds

Alarm Specifications
Pulse a

Range Adult/pedi/neo: 30–300 bpm


SpO2
Range • Adult: 50–100% Adjustment Adult:
• Pedi/neo: 30–100% • 1 bpm steps (30–40 bpm)
• 5 bpm steps (40–300 bpm)
Adjustment 1% steps Pedi/neo:
• 1 bpm steps (30–50 bpm)
Delay 0–30 seconds (0, 1, 2, 3,... 30) • 5 bpm steps (50–300 bpm)
+ 4 seconds
Delay Maximum 14 seconds

Desat
Tachycardia
Range • Adult: 50–99%
• Pedi/neo: 30–99% Range • Difference to high limit: 0–50 bpm
• Clamping at 150–300 bpm
Adjustment 1% steps
Adjustment 5 bpm steps
Delay 0–30 seconds (0, 1, 2, 3,... 30)
+ 4 seconds Delay Maximum 14 seconds

SpMet Bradycardia

Range Adult/pedi/neo: 0–100% Range • Difference to low limit: 0–50 bpm


• Clamping at 30–100 bpm
Adjustment • 0.1% steps (0–9.9%)
• 1% steps (10–100%) Adjustment 5 bpm steps

Delay Maximum 4 seconds Delay Maximum 14 seconds

SpCO PVI

Range Adult/pedi/neo: 0–100% Range Adult/pedi/neo: 0–100%

Adjustment 1% Adjustment 1%

Delay Maximum 4 seconds Delay Maximum 4 seconds

SpHb RRac b

Range Adult/pedi/neo: 0–25 g/dl Range • Adult/pedi: 0–100 rpm


(0–15.5 mmol/l) • Neo: 0–150 rpm

Adjustment • 0.1 g/dl steps (0–9.9 g/dl) Adjustment • 1 rpm steps below 20 rpm
0.1 mmol/l (0–9.9 mmol/l) • 5 rpm steps above 20 rpm
• 0.5 g/dl steps (10–25 g/dl)
0.5 mmol/l (10–15.5 mmol/l) Delay 0-60 seconds (0, 10, 15, 30, 60)
+ 4 seconds
Delay Maximum 4 seconds

RRac Pause Time


SpOC
15, 20, 25, 30, 35, 40 seconds.
Range Adult/pedi/neo: 0–35 ml/dl

17
Perf Diastolic

Range Adult/pedi/neo: 0.02–20 Range • Adult: 10–245 mmHg (1.5–32 kPa)


• Pedi: 10–150 mmHg (1.5–20 kPa)
Adjustment • 0.01 steps (0.02–0.10) • Neo: 10–100 mmHg (1.5–13 kPa)
• 0.10 steps (0.10–1)
• 1 steps (1–20)
Mean
Delay Maximum 4 seconds
Range • Adult: 20–255 mmHg (2.5–34 kPa)
a.
• Pedi: 20–160 mmHg (2.5–21 kPa)
The Masimo rainbow SET technology only provides pulse rate values
• Neo: 20–120 mmHg (2.5–16 kPa)
up to 240 bpm. To get pulse rate alarms, set the high alarm limit below
240 bpm.
b.
The Masimo rainbow SET technology only provides respiration rate
Pulse Rate
values from 4 rpm to 70 rpm. For respiration rate alarms, set the high
alarm limit below 70 rpm and the low alarm limit above 4 rpm.
Range • Adult: 40–300
• Pedi: 40–300
3D Perf Delta
• Neo: 40–300

% Decrease Adjustment Duration Adjustment


Accuracy
10–100% 2% 1 min to 1 min, 5 min,
48 hr, 30 min, 1 hr, Max. Std. Deviation 8 mmHg (1.1 kPa)
infinite 4 hr, 8 hr, 12 hr,
24 hr, 36 hr, Max. Mean Error ±5 mmHg (±0.7 kPa)
48 hr, infinite

Pulse Rate Measurement


3D Desat Index
Accuracy • 40–100 bpm: ±5 bpm
• 101–200 bpm: ±5% of reading
Delta Threshold
• 201–300 bpm: ±10% of reading
Range 2–10% (average over NBP measurement
cycle)
Adjustment 1%

Count
Measurement Time
Range 1–25
Typical at HR >60 bpm
Adjustment 1 step
Auto/manual • Adult: 30 seconds
• Neo: 25 seconds
Period
• Stat: 20 seconds
Range 1–4 hours
Maximum time • Adult/pedi: 180 seconds
• Neo: 90 seconds
Adjustment 1 hour steps

Noninvasive blood pressure (NBP) Cuff Inflation Time


Complies with:
Typical for normal adult <10 seconds
• IEC 80601-2-30:2010 + A1:2013
cuff
• EN 80601-2-30:2010 + A1:2015

NBP Performance Specifications Typical for neonatal cuff <2 seconds

Systolic
Range • Adult: 30–270 mmHg (4–36 kPa) Initial Cuff Inflation Pressure
• Pedi: 30–180 mmHg (4–24 kPa)
• Neo: 30–130 mmHg (4–17 kPa) • Adult: 165 ±15 mmHg
• Pedi: 130 ±15 mmHg
• Neo: 100 ±15 mmHg

18
Maximum Cuff Pressure Diastolic

• Adult/pedi: 300 mmHg Adjustment • 10–30 mmHg (1.5–4 kPa): 2 mmHg


• Neo: 150 mmHg (0.5 kPa)
• >30 mmHg (>4 kPa): 5 mmHg
(1 kPa)
Auto Mode Repetition Times

1, 2, 2.5, 3, 5, 10, 15, 20, 30,


Mean
45 minutes, or 1, 2, 4, 8, 12, 24 hours
Range • Adult: 20–255 mmHg (2.5–34 kPa)
• Pedi: 20–160 mmHg (2.5–21 kPa)
STAT Mode Cycle Time • Neo: 20–120 mmHg (2.5–16 kPa)

5 minutes Adjustment • 10–30 mmHg (1.5–4 kPa): 2 mmHg


(0.5 kPa)
• >30 mmHg (>4 kPa): 5 mmHg
Venipuncture Mode Inflation (1 kPa)

Inflation pressure • Adult: 20–120 mmHg (3–16 kPa)


• Pedi: 20–80 mmHg (3–11 kPa) NBP Overpressure Settings (Not user adjustable)
• Neo: 20–50 mmHg (3–7 kPa)
Adult >300 mmHg (40 kPa)
Automatic deflation • Adult/pedi: after 170 seconds >2 seconds
• Neo: after 85 seconds
Pedi >300 mmHg (40 kPa)
Measurement Validation: >2 seconds
Clinical investigation according to ISO 81060-2:2013 with the
Neo >150 mmHg (20 kPa)
auscultatory reference method:
>2 seconds
• The 5th Korotkoff sound (K5) was used in adult / adolescent
subjects and the 4th Korotkoff sound (K4) was used in
pediatric subjects to determine the diastolic reference Invasive Pressure and Pulse
pressures.
Supports up to two pressure transducers via one connector
• The approximation MAP = (2*DIA + SYS) / 3 was used to
and one Y-cable.
calculate reference MAP (mean arterial pressure) values from
the systolic and diastolic reference pressures. Complies with:
• IEC 60601-2-34:2011
Clinical investigation according to ISO 81060-2:2013 with the
• EN 60601-2-34:2014
intra-arterial reference method:
• The radial artery was used for the intra-arterial reference
Invasive Pressure Performance Specifications
measurement.
• The MAP values displayed by the reference invasive blood
pressure monitor were used as MAP reference values.
Measurement Range
Blood pressure recordings with any arrhythmias were
-40–360 mmHg
excluded.

NBP Alarm Specifications


Pulse Rate

Range 25–350 bpm


Systolic
Range • Adult: 30–270 mmHg (4–36 kPa) Accuracy ±1% full range
• Pedi: 30–180 mmHg (4–24 kPa)
• Neo: 30–130 mmHg (4–17 kPa) Resolution 1 bpm

Adjustment • 10–30 mmHg (1.5–4 kPa): 2 mmHg


(0.5 kPa) Input Sensitivity
• >30 mmHg (>4 kPa): 5 mmHg
(1 kPa) Sensitivity 5 μV/V/mmHg (37.5 μV/V/kPa)

Adjustment range ±10%


Diastolic

Range • Adult: 10–245 mmHg (1.5–32 kPa) Transducers (Compliant with ANSI/AAMI BP22)
• Pedi: 10–150 mmHg (1.5–20 kPa)
• Neo: 10–100 mmHg (1.5–13 kPa) Load impedance 200–2000  (resistive)

19
Transducers (Compliant with ANSI/AAMI BP22) Extreme High

Output impedance 3000  (resistive) Delay Maximum 12 seconds

Frequency Response Extreme Low

DC to 12 Hz or 40 Hz Range Difference to low limit 0–25 mmHg


(0–3.5 kPa)

Zero Adjustment Adjustment 5 mmHg steps (0.5 kPa)

Range ±200 mmHg (±26 kPa) Range Clamping at -40–355 mmHg


(-5–47 kPa)
Accuracy ±1 mmHg (±0.1 kPa)
Adjustment 5 mmHg steps (1.0 kPa)
Drift <0.1 mmHg/°C (0.013 kPa/°C)
Delay Maximum 12 seconds

Gain Accuracy
Pulse
Accuracy ±1%
Range 25–300 bpm
Drift <0.05%/°C
Adjustment Adult:
Non linearity and Error of  0.4% FS (@CAL • 1 bpm steps (25–40 bpm)
Hysteresis 200 mmHg) • 5 bpm steps (40–300 bpm)
Pedi/neo:
• 1 bpm steps (25–50 bpm)
Overall Accuracy (including transducer) • 5 bpm steps (50–300 bpm)

±4% of reading or ±4 mmHg Delay Maximum 12 seconds


(±0.5 kPa), whichever is greater

Tachycardia
Volume displacement of CPJ840J6
Range • Difference to high limit 0–50 bpm
0.1 mm3/100 mmHg • Clamping at 150–300 bpm

Adjustment 5 bpm steps


Invasive Pressure Alarm Specifications
Delay Maximum 14 seconds
Pressure
Range -40–360 mmHg (-5.0–48 kPa) Bradycardia

Adjustment • -40–50 mmHg (-5–4 kPa): Range • Difference to low limit 0–50 bpm
2 mmHg (0.5 kPa) • Clamping at 25–100 bpm
• >50 mmHg (>4 kPa): 5 mmHg
(1 kPa) Adjustment 5 bpm steps

Delay Maximum 12 seconds Delay Maximum 14 seconds

Extreme High
Temperature
Complies with:
Range Difference to high limit 0–25 mmHg • ISO 80601-2-56:2009
(0–3.5 kPa) • EN ISO 80601-2-56:2012

Adjustment 5 mmHg steps (0.5 kPa) Temp Performance Specifications

Range Clamping at -35–360 mmHg


(-4–48 kPa) Temp
Range (absolute) -1–45°C (30–113°F)
Adjustment 5 mmHg steps (1.0 kPa)
Range (differential) ±46°C (±115°F)

20
Temp awRR
Resolution 0.1°C (0.1°F) Accuracy ±1 rpm

Accuracy ±0.1°C (±0.2°F)


Warm-up Time

Average Time Constant 2 minutes with CO2 transducer


attached for full accuracy
<10 seconds specification

Temp Alarm Specifications


Response Time

<60 ms (with adult or infant


Temp High/Low Alarms
reusable or disposable adapter)
Range -1–45°C (30–113°F)
Sidestream CO2 Performance Specifications
Adjustment • -1–30°C (30–86°F), 0.5°C (1.0°F)
steps
• 30–45°C (86–113°F), 0.1°C (0.2°F)
CO2
steps
Range 0–150 mmHg (0–20 kPa)
CO2 Accuracy After 2 minutes warm-up:
Complies with: • For values between 0 and
• ISO 80601-2-55:2011 40 mmHg (0 and 5,3 kPa):
• EN ISO 80601-2-55:2011 ±2.0 mmHg (±0.29 kPa).
• For values from 41–70 mmHg
Mainstream CO2 Performance Specifications (5.4–9.3 kPa): ±5% of reading.
• For values from 71–100 mmHg
(9.4–13.3 kPa) ±8% of reading.
CO2 • For values from 101–150 mmHg
(13.4–20 kPa): ±10% of reading.
Range 0–150 mmHg (0–20 kPa)
At respiration rates above 80 rpm,
all ranges are ±12% of reading. The
Accuracy After 2 minutes warm-up:
specifications are valid for gas
• For values between 0 and
mixtures of CO2, balance N2, dry
40 mmHg (0 and 5,3 kPa):
gas at 760 mmHg (101.3 kPa) within
±2.0 mmHg (±0.29 kPa).
specified operating temperature
• For values from 41–70 mmHg
range.
(5.4–9.3 kPa): ±5% of reading.
• For values from 71–100 mmHg
Resolution • Numeric: 1.0 mmHg (0.1 kPa)
(9.4–13.3 kPa) ±8% of reading.
• Wave: 0.1 mmHg (0.01 kPa)
For values from 101–150 mmHg
(13.4–20 kPa): ±10 % of reading the
Stability:
specifications are valid for standard
gas mixtures, balance air, fully
Short-term drift ±0.8 mmHg (0.11 kPa) over four
hydrated at 35°C, Pabs = 760 mmHg
hours.
(101.3 kPa), flow rate = 2 l/min
Long-term drift Accuracy specification is
Resolution • Numeric: 1.0 mmHg (0.1 kPa)
maintained over a 120-hour period
• Wave: 0.1 mmHg (0.01 kPa)

Stability:
awRR
Short-term drift ±0.8 mmHg (0.11 kPa) over four
Range 2–150 rpm
hours.
Accuracy ±1 rpm
Long-term drift Accuracy specification is
maintained over a 120-hour period
Warm-up Time
awRR
2 minutes with CO2 sensor attached
Range 2–150 rpm for full accuracy specification

21
Sample Flow Rate Apnea Delay
Adjustment 5 second steps
50 ±10 ml/minute
Delay Set apnea delay time + 4 seconds

Total System Response Time


Ordering Information
3 seconds

Base Unit
CO2 Alarm Specifications
Philips 867030 including:
- 1 x Lithium-ion battery
etCO2 High a. Not available for sale in the U.S.

Range 20–95 mmHg (2–13 kPa)


Mandatory Options
Adjustment 1 mmHg (0.1 kPa) steps
Application Areas
Delay <14 seconds
Critical Care Transport Software, includes: H72
- Full Arrhythmia Capability
- ST/STE Map
etCO2 Low
- Full Networking
Range 10–90 mmHg (1–12 kPa) - Timers
- Alarm Visualization
Adjustment 1 mmHg (0.1 kPa) steps - Smart Alarm Delay
- QT Analysis
Delay <14 seconds - Hexad derived 12-lead ECG
- Full Customization

imCO2 High
Waves
Range 2–20 mmHg (0.3–3 kPa)
3-wave capability A03
Adjustment 1 mmHg (0.1 kPa) steps
4-wave capability A04
Delay <14 seconds
5-wave capability A05

awRR High
SpO2 Technology
Range • Adult/pedi: 10–100 rpm
• Neo: 30–150 rpm FAST SpO2 SP1

Adjustment • <20 rpm: 1 rpm steps Masimo rainbow SET SpO2 SP5
• >20 rpm: 5 rpm steps
Nellcor OxiMax SpO2 SP6
Delay <14 seconds
Add-On Options
awRR Low
Measurement Options
Range • Adult/pedi: 0–95 rpm
• Neo: 0–145 rpm Dual SpO2 B02 a

Adjustment • <20 rpm: 1 rpm steps Respironics CO2 ready B03 a


• >20 rpm: 5 rpm steps
Dual Press and Temp B06 b
Delay • Settings <20 rpm: <4 seconds
• Settings >20 rpm: <14 seconds

Apnea Delay
Range 10–40 seconds

22
a.
Check availability in your country.
Measurement Options
a.
Only available with Philips FAST SpO2
Sensors and Disposables Options
b.
Requires the use of Dual IBP Adapter (option K14), or Transpac IV Dual
IBP Cable (option K16) Starter Kits
12-lead Accessories Bundle ICU-AAMI G01
Clinical Applications
12-lead Accessories Bundle ICU-IEC G02
Parameter Histograms C09
12-lead Accessories Bundle OR-AAMI G03
Conventional 12-Lead ECG C12
12-lead Accessories Bundle OR-IEC G04

XDS Options 5-lead Accessories Bundle ICU-AAMI G06


XDS Connectivity X00
5-lead Accessories Bundle ICU-IEC G07
XDS Clinical Workstation X30
5-lead Accessories Bundle OR-AAMI G08
XDS Database X40
5-lead Accessories Bundle OR-IEC G09

Accessories Bundle Neonatal-AAMI G14


Pulse Oximetry Options
Masimo rainbow SpHb + SpOC R01 Accessories Bundle Neonatal-IEC G15

Masimo rainbow SpCO R02 3-lead Accessories Bundle ICU-AAMI G16

Masimo rainbow SpMet R03 3-lead Accessories Bundle ICU-IEC G17

Masimo rainbow PVI R04 3-lead Accessories Bundle OR-AAMI G18

SpHb + SpOC + PVI, includes: R11 3-lead Accessories Bundle OR-IEC G19
- Masimo rainbow SpHb + SpOC - R01
- Masimo rainbow PVI - R04
Invasive Pressure Accessories
SpHb + SpOC + PVI + SpMet + SpCO, includes: R12
Dual IBP Adapter - for use with existing K14
- Masimo rainbow SpHb + SpOC - R01
Philips-compatible invasive pressure cables
- Masimo rainbow SpCO - R02
- Masimo rainbow SpMet - R03
Transpac IV Dual IBP Cable - for use with K16
- Masimo rainbow PVI - R04
compatible ICU Medical pressure transducers
Masimo RainbowAcousticMon R21
Respironics CO2
Wireless Interfaces CO2 Mainstream Sensor N01
802.11 Wireless IF J35
Reusable Adult/Pediatric Airway Adapter N02
a.
Smart Hopping IF 1.4 GHz J45
Reusable Infant Airway Adapter N03

Single-Use Adult Airway Adapter N04


Hardware Add-Ons
Fix Clamp Mount E20 Single-Use Infant Airway Adapter N05

Bedhanger Mount E21 LoFlo Sidestream CO2 Sensor N11

Add 1 Lithium-ion Battery (includes battery charger Non-intubated Adult Airway Adapter (Sidestream) N12
E24
adapter)
Non-intubated Pediatric Airway Adapter N13
Rotatable Quick Claw Mount E29 (Sidestream)

Carrying Handle E31 Intubated Adult Airway Adapter (Sidestream) N14

IntelliVue Dock E50 Intubated Pediatric Airway Adapter (Sidestream) N15

Sync Signal Cable SN3


Supplies and Accessories
For information about supplies and accessories, refer to the
separate “Philips IntelliVue Accessories” technical data sheet.

Related Products
M3086A IntelliVue Support Tool. Available on DVD and via
InCenter. For more information, see: www3.medical.philips.
com/resources/hsg/docs/en-us/custom/Intellivue_order.asp.

Documentation
All documentation is available in .pdf format on a
documentation DVD that is shipped with the product.
Additionally, a predefined number of printed Instructions for
Use ships with each order.

© 2017 Koninklijke Philips N.V. All rights reserved. How to reach us


Specifications are subject to change without notice. www.healthcare.philips.com
Trademarks are the property of Koninklijke Philips [email protected]
N.V. or their respective owners.

4522 991 23321 * FEB 2017

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