Patient Data Module: Service Manual

Patient Data Module
Service Manual
Software version 2
For use with the Solar 8000M/i and Transport Pro patient monitors
Patient Data Module

English
2nd edition
2030046-006
© 2017-2018 General Electric Company.
All rights reserved.
Due to continuing product innovation, specifications in this manual are subject to change without notice.
For technical documentation purposes, the abbreviation GE is used for the legal entity names, GE Medical Systems Information Technologies,
Inc. and GE Healthcare Finland Oy.
2 Patient Data Module 2030046-006

2018-05-21
Contents
1 About this manual ......................................................................................... 9
Intended use of this manual........................................................................... 9
Intended audience of this manual ................................................................. 9
Manual conventions ....................................................................................... 9
Module naming conventions ...................................................................... 10
Other naming conventions ......................................................................... 10
Illustrations and names ................................................................................ 10
Related documents....................................................................................... 10
Revision history ............................................................................................. 10
Ordering manuals ......................................................................................... 10
Product availability ....................................................................................... 10
Trademarks ................................................................................................... 11
Third party trademarks ............................................................................... 11
Manufacturer responsibility ......................................................................... 11
2 Safety ............................................................................................................13
Safety message signal words....................................................................... 13
Safety symbols .............................................................................................. 13
System safety................................................................................................ 14
Equipment warning....................................................................................... 14
Intended use.................................................................................................. 14
3 Module introduction ....................................................................................17
PDM introduction .......................................................................................... 17
Main components ......................................................................................... 18
Controls and connectors ............................................................................ 18
Indicators..................................................................................................... 19
Data Acquisition System board .................................................................. 20
Internal main components ......................................................................... 20
ePort host interface cable .......................................................................... 21
PDM battery................................................................................................. 21
Docking stations.......................................................................................... 21
Measurement principle................................................................................. 21
2030046-006 Patient Data Module 3

Equipment symbols ...................................................................................... 21
Service information....................................................................................... 23
Service requirements .................................................................................. 23
Unique Device Identifier (UDI) .................................................................... 24
Equipment identification............................................................................. 24
4 Service tool and configuration...................................................................27
PDM Service Tool interface........................................................................... 27
Equipment required to use the PDM Service Tool ....................................... 27
PC connections and setup............................................................................ 27
Connecting the PDM and service computer to the Solar 8000M/I
patient monitor............................................................................................ 27
Connecting the PDM and service computer to the PDM service
adapter ........................................................................................................ 28
Changing the IP address on a Windows 7 service computer................... 29
Disabling the firewall or networking services on a Windows 7 service
computer ..................................................................................................... 30
Logging on to the PDM Service Tool from Windows 7................................ 30
PDM Service Tool modules ........................................................................... 30
Information module ...................................................................................... 31
Viewing PDM Device Information............................................................... 31
Printing PDM Device Information ............................................................... 31
Configuration module................................................................................... 31
Asset Settings .............................................................................................. 32
ECG Filter Config page ................................................................................ 32
Licensing ...................................................................................................... 33
Software Transfer........................................................................................ 33
Diagnostics module ...................................................................................... 33
Downloading or viewing log files ............................................................... 33
Viewing PDM service metrics ..................................................................... 33
Analog outputs calibration ........................................................................... 34
Required tools for analog output calibration ............................................ 34
Making connections for analog outputs calibration................................. 34
Calibrating analog outputs......................................................................... 34
5 Installation....................................................................................................37
Unpacking ..................................................................................................... 37

Inspecting the PDM equipment before installation..................................... 37
Installing batteries ........................................................................................ 38
Testing the battery charge ......................................................................... 38
Replacing the PDM battery ......................................................................... 38
PDM software ................................................................................................ 40
Mounting options .......................................................................................... 40
Mounting points to note ............................................................................. 41
Connecting to bedside monitor.................................................................. 42
Connecting the PDM to a transport monitor ............................................. 43
Performing an admit/discharge cycle on the PDM .................................... 44
Installation check procedure........................................................................ 45
Performing visual inspection ...................................................................... 45
Checking that the battery indicator displays ............................................ 45
PDM parameter checkout tests using a Solar 8000M/I patient
monitor ........................................................................................................ 45
6 Planned and corrective maintenance .......................................................47
About the maintenance check procedures ................................................. 47
Manufacturer responsibility ......................................................................... 47
Corrective maintenance ............................................................................... 47
Planned maintenance................................................................................... 48
Performing visual inspection........................................................................ 49
Performing electrical safety tests *.............................................................. 49
Performing functional check for PDM.......................................................... 49
Functional check for Defib/Sync analog outputs........................................ 49
Required tools.............................................................................................. 49
Connections................................................................................................. 50
Monitor configuration ................................................................................. 50
Simulator configuration .............................................................................. 50
Analog output and defibrillator synchronization marker out signals
tests.............................................................................................................. 50
Maintaining the battery ................................................................................ 52
About the lithium-ion battery ..................................................................... 52
Improving battery performance................................................................. 52
Battery storage recommendations............................................................ 53

Testing the battery charge ......................................................................... 53
Charging a battery inside the module ....................................................... 53
Charging a battery using an external battery charger............................. 53
Conditioning the battery............................................................................. 53
Battery recycling ......................................................................................... 55
7 Troubleshooting...........................................................................................57
Troubleshooting guidelines .......................................................................... 57
Performing visual inspection for the PDM ................................................... 57
Troubleshooting module functionality......................................................... 58
PDM error messages..................................................................................... 58
Required troubleshooting tools and equipment ......................................... 60
Troubleshooting the absence of parameter data....................................... 61
Troubleshooting poor quality parameter data............................................ 61
Troubleshooting invasive pressure measurement...................................... 61
Troubleshooting temperature measurement.............................................. 62
Troubleshooting non-invasive blood pressure measurement ................... 62
Troubleshooting the loss of communication............................................... 62
Troubleshooting loss of power at the module............................................. 63
Troubleshooting exterior damage ............................................................... 63
Troubleshooting docking issues................................................................... 64
Troubleshooting temperature & voltage rails service metrics ................... 64
ta_Troubleshooting_slow_%20tabular_graphical_trends_updates.dita........... 64
Troubleshooting Solar 8000M/I patient monitor CONNECTING
messages ...................................................................................................... 64
Troubleshooting the battery......................................................................... 65
8 Disassembly and reassembly.....................................................................67
Disassembly guidelines ................................................................................ 67
ESD precautions .......................................................................................... 67
Before PDM disassembly ............................................................................ 68
Reassembly precautions............................................................................. 68
Required tools.............................................................................................. 68
Disassembly procedures .............................................................................. 68

Replacing the PDM front labels .................................................................. 70
Replacing the PDM bottom label................................................................ 71
Replacing the PDM battery door and tray ................................................. 71
Replacing the PDM pull tab and mount rail............................................... 72
Replacing the PDM top housing ................................................................. 73
Replacing the PDM main board.................................................................. 75
Replacing the PDM NIBP hose and coupling ............................................. 76
Replacing the PDM NIBP assembly with manifold hose ........................... 76
Replacing the PDM main flex circuit assembly.......................................... 78
Reassembling the module .......................................................................... 81
9 Service parts.................................................................................................83
Ordering parts ............................................................................................... 83
PDM exploded views ..................................................................................... 84
Exploded view of mount rail and housing assembly, PDM ....................... 84
Exploded view of NIBP assembly, PDM ...................................................... 85
Exploded view of main board assembly, PDM........................................... 85
Exploded view of flex assembly, PDM ........................................................ 86
List of FRUs for PDM...................................................................................... 86
10 Maintenance check form ............................................................................91
Solar 8000M/I Patient Monitor Maintenance Check Form ......................... 91
Visual inspection ........................................................................................... 91
Electrical safety checks ................................................................................ 92
Functional check ........................................................................................... 95
11 Compliance and specifications ..................................................................99
Design, environmental, and physical specifications................................... 99
PDM specifications ...................................................................................... 99
PDM battery specifications......................................................................... 99
Standards compliance................................................................................ 100
IEC 60601-1 ................................................................................................. 100
Parameter specifications............................................................................ 100
ECG standards compliance ...................................................................... 100
ECG performance specifications .............................................................. 101
Impedance respiration performance specifications............................... 103
SpO2 standards compliance ..................................................................... 104

SpO2 displayed saturation values ............................................................ 104
SpO₂ summary of clinical studies used to establish accuracy
claims......................................................................................................... 104
SpO2 test methods used to establish accuracy claims during
motion........................................................................................................ 105
SpO₂ test methods used to establish accuracy claims during low
perfusion.................................................................................................... 106
SpO₂ test methods used to establish pulse rate accuracy..................... 106
SpO2 performance specifications ............................................................ 106
NIBP standards compliance ..................................................................... 109
NIBP performance specifications............................................................. 109
Invasive pressure standards compliance ................................................ 110
Invasive pressure performance specifications........................................ 110
Temperature standards compliance........................................................ 111
Temperature performance specifications ............................................... 111
C.O. standards compliance....................................................................... 111
Cardiac output (C.O.) performance specifications................................... 111
12 Electromagnetic compatibility (EMC) ......................................................113
IEC 60601-1-2.............................................................................................. 113
Essential performance in EMC ................................................................... 113
Electromagnetic compatibility safety precautions ................................... 114
Electromagnetic emissions ........................................................................ 114
Electromagnetic immunity ......................................................................... 115
Recommended separation distances........................................................ 116
Compliant cables and accessories ............................................................ 117

About this manual
1
Intended use of this manual
This manual contains instructions for the planned and corrective maintenance of the
acquisition module. This manual must be used together with the monitor’s service
manual for important safety and installation information.
Use the manual as a guide for maintenance procedures and repairs considered field
repairable. Where necessary the manual identifies additional sources of relevant
information and technical assistance.
See the monitor’s service manual for an overview of the patient monitoring
system, information needed for system installation and for planned and corrective
maintenance of the monitor.
See the monitor’s supplemental information manual for the technical specifications,
default settings and compatibility information, including electromagnetic compatibility.
See the monitor’s user manual for the instructions necessary to operate the device
safely in accordance with its function and intended use.
Intended audience of this manual

This manual is intended for service representatives and technical personnel who
install, maintain, troubleshoot, or repair this device.
Manual conventions
This manual uses the following styles to emphasize text or indicate an action. Also
note the terminology conventions.
Item Description
bold Indicates hardware keys and connectors.
bold italic Indicates menu options, software keys and messages.
italic Indicates terms for emphasis.
> Indicates menu options to select consecutively.
select The word select means choosing and confirming.
NOTE Note statements provide application tips or other useful

information.

About this manual
Module naming conventions

In this manual, the Patient Data Module is also referred to as PDM. When a generic
term is more appropriate, it is referred to as the acquisition module, device, or module.
Other naming conventions

For technical documentation purposes, the abbreviation GE is used for the legal entity
names, GE Medical Systems Information Technologies, Inc.
In this manual, the document name for a user manual and operator’s manual are
interchangeable.
In this manual, the Solar 8000M/I or Transport Pro patient monitors are referred to
as the Solar 8000M/I monitor or Transport Pro monitor. When a generic term is more
appropriate, it is referred to as the bedside monitor, host monitor, transport monitor, or
monitor.
Illustrations and names

This manual uses illustrations as examples only. Illustrations in this manual may not
necessarily reflect all system settings, features, configurations, or displayed data.
Names of persons, institutions, and places and related information are fictitious; any
similarity to actual persons, entities, or places is purely coincidental.
Related documents
● Patient Data Module Software Installation Instructions
● CARESCAPE Modular Monitors Mounting Solutions
● CARESCAPE Monitors Supplemental Information Manual
● Solar 8000M/I Patient Monitor Service Manual
● Solar 8000M/I Patient Monitor Operator’s Manual
● Transport Pro Patient Monitor Service Manual
● Transport Pro Patient Monitor Operator’s Manual
Revision history
Revision Description
1st Edition Initial release.
2nd Edition Updated FRU information.
Ordering manuals
A paper copy of this manual will be provided upon request. Contact your local GE
representative and request the part number on the first page of the manual.
Product availability
NOTE Due to continual product innovation, design and specifications
for these products are subject to change without notice.

About this manual
Some of the products mentioned in this manual may not be available in all countries.
Please consult your local representative for the availability.
Trademarks
GE, GE Monogram, Solar and CARESCAPE are trademarks of General Electric Company.
Third party trademarks

All third party product and company names are the property of their respective
owners.
Manufacturer responsibility
GE is responsible for the effects on safety, reliability, and performance of the
equipment only if:
● Assembly operations, extensions, readjustments, modifications, servicing, or
repairs are carried out by authorized service personnel.
● The electrical installation of the relevant room complies with the requirements
of the appropriate regulations.
● The equipment is used in accordance with the instructions for use.
● The equipment is installed, maintained and serviced in accordance with the
instructions provided in the related service manuals.

About this manual

Safety
2
Safety message signal words
Safety message signal words designate the severity of a potential hazard.
DANGER Indicates a hazardous situation that, if not avoided, will result
in death or serious injury.
WARNING Indicates a hazardous situation that, if not avoided, could

result in death or serious injury.
CAUTION Indicates a hazardous situation that, if not avoided, could

result in minor or moderate injury.
NOTICE Indicates a hazardous situation not related to personal injury

that, if not avoided, could result in property damage.
Safety symbols
Symbol Explanation
General warning sign. ISO 7010.
This symbol is identified by a yellow background, black triangular band, and
a black symbol.
Caution. ISO 7000.
This symbol is identified by a white background, black triangular band, and
a black symbol.
Follow instructions for use. ISO 7010.
This symbol indicates mandatory action and it is identified by a blue
background and a white symbol.
Consult operating instructions. / Operating instructions.
WARNING — Electric shock hazard. This equipment must be serviced by

qualified service personnel only.
ISO 7010.
This symbol is identified by a yellow background, black triangular band, and
a black symbol.

Safety
Symbol Explanation
MR Unsafe. Indicates that the device is not intended for use in an MR
environment.
This symbol is identified by a white background, red or black circular band, and
a black symbol.
Electrostatic sensitive device. Connections should not be made to this device

unless ESD precautionary procedures are followed.
Non-ionizing electromagnetic radiation. Interference may occur in the vicinity

of this device.
Type BF (IEC 60601-1) protection against electric shock. Isolated (floating)

applied part suitable for intentional external and internal application to the
patient, excluding direct cardiac application.
Type BF (IEC 60601-1) defibrillator-proof protection against electric shock.

Isolated (floating) applied part suitable for intentional external and internal
application to the patient, excluding direct cardiac application.
Type CF (IEC 60601-1) protection against electric shock. Isolated (floating)

applied part suitable for intentional external and internal application to the
patient, including direct cardiac application.
Type CF (IEC 60601-1) defibrillator-proof protection against electric shock.

Isolated (floating) applied part suitable for intentional external and internal
application to the patient including direct cardiac application.
Safety ground. Remove power cord from the mains source by grasping the
plug. Do not pull on the cable.
U.S. only:
System safety
For a complete list of system safety messages that apply to the entire system, refer to
the user manual. For safety messages specific to parts of the system or to a certain
installation or service task, refer to the relevant sections.
Equipment warning
WARNING ACCIDENTAL SPILLS — To avoid electric shock or device
malfunction liquids must not be allowed to enter the device. If
liquids have entered a device, take it out of service and have it
checked by a service technician before it is used again.
Intended use
This device is intended for use under the direct supervision of a licensed health care
practitioner.
This device is not intended for home use.

Safety
Contact your local GE representative for information before connecting any devices to
the equipment that are not recommended in this manual.
Parts and accessories used must meet the requirements of the applicable IEC 60601
series safety standards, and/or the system configuration must meet the requirements
of the IEC 60601 medical electrical systems standard.
Periodically, and whenever the integrity of the device is in doubt, test all functions.
The use of accessory equipment not complying with the equivalent safety
requirements of this equipment may lead to a reduced level of safety of the resulting
system. Consideration relating to the choice shall include:
● use of the accessory in the patient vicinity; and
● evidence that the safety certification of the accessory has been performed in
accordance to the appropriate IEC 60601-1 and/or IEC 60601-1-1 harmonized
national standard.
If the installation of the equipment, in the USA, will use 240V rather than 120V, the
source must be a center-tapped, 240V, single-phase circuit.

Safety

Module introduction
3
PDM introduction
This document provides information for maintenance and service of the Patient Data
Module (PDM). This document only supports the PDM with the hardware product code
SPX and software version 2. Due to continuing product innovation, the specifications
in this document are subject to change without notice.
The PDM is a data acquisition device for a CARESCAPE modular monitor and Solar
8000M/I or Transport Pro patient monitors. It provides a connection from the monitor
to the patient, processes the patient data signals and stores a limited amount of
patient data (24 hours captured at 1 minute resolution) for seamless transport.
Calculated parameters are:

● ECG/impedance respiration
● Up to four invasive blood pressure channels
● Two temperature channels or cardiac output
● Pulse oximetry
● Non-invasive blood pressure
● Defibrillator sync/analog out interface

Module introduction
Main components
Controls and connectors
Front panel of the PDM:
Connector Description
ECG ECG and impedance respiration connector (green).
Temp/CO Temperature and cardiac output connector (brown).
P1/P3 Invasive blood pressure channel 1 and channel 3 connector (red).
P2/P4 Invasive blood pressure channel 2 and channel 4 connector (red).
SpO₂ Pulse oximetry connector for Masimo or Nellcor technology. (blue).
NIBP Non-invasive blood pressure connector.
Defib/Sync Defibrillator synchronization connector (white).
Communication indicator light.
Power indicator light.
Back panel of the PDM:
Connector Description
ePort ePort host interface connector.
Battery door Battery compartment door.
ePort host interface connector

The PDM connects to a monitor using the ePort host interface connector and an ePort
host interface cable, carrying power and communication to the module.
Defibrillation/Sync connector
The defibrillator/Sync connector carries analog and digital signals to auxiliary devices.

Module introduction
PDM keys
The power/zero all key has a dual role as a power on and zero all function.
Power on — Turns the data acquisition function ON. Power is derived
from a battery or monitor. When turned on, the function changes to
the zero all function.
Zero all — Zeros all invasive pressure lines which are open to atmosphere.
Each pressure can also be zeroed, if desired, with a menu option in the
pressure menu.
Indicators
Communication and power indicators:
1. Communication icon and indicator.

2. Power icon and indicator.
3. Power ON/IBP Zero All key.
Communication indicator
The following LED condition identifies the communication status with a monitor:
● No light indicates no communication.
● Solid amber indicates an application reset.
● Solid green indicates communication.
● Flashing amber indicates communication failure.
● Alternately flashing with the power LED indicates software transfer.
Power indicator
The following LED condition identifies the power status:
● No light indicates no power applied.
● Solid amber indicates software booting up.
● Solid green indicates powered by AC-derived mains or battery.
● Flashing amber indicates approximately five minutes battery power remaining
● Alternately flashing with the communication LED indicates software transfer.

Module introduction
Data Acquisition System board

The Data Acquisition System board, referred to as DAS, consists of two independent
patient parameter acquisition subsystems. The first subsystem, referred to as the
Main DAS, provides interfaces to one pulse oximetry transducer, four invasive pressure
transducers, one non-invasive blood pressure transducer, and either two temperature
transducers or one thermal dilution cardiac output transducer.
The second subsystem, referred to as the ECG DAS, provides interfaces to ten ECG
electrodes. It also supports the measurement of impedance-based respiration from
up to three differential pairs of ECG electrodes and the detection of pacemaker activity
from up to three differential pairs of ECG electrodes for the purpose of pacemaker
identification. The ECG and respiration circuitry is electrically isolated from all the
other parameters. Each isolated parameter section contains a processing unit and
a serial communication unit. Communications are implemented through a custom
serial communication link.
Internal main components

The PDM contains a main processor board, NIBP assembly with tubing, and Data
Acquisition System.
The PDM shares power and communicates with host devices through the host
interface connection called the ePort. The PDM connects directly to a transport
monitor through a docking station. The PDM connects to the bedside host patient
monitor through the bedside docking station and an ePort host interface cable. The
PDM can connect to the bedside host patient monitor with just an ePort host interface
cable without the docking station.

Module introduction
ePort host interface cable

The ePort host interface cable provides external power and communication between
the PDM and a monitor.
PDM battery
The PDM is designed to operate on battery power when used with a transport monitor
or whenever AC power is interrupted. A complete battery management system allows
you to obtain maximum battery performance. When connected to a bedside monitor,
audible and visual alarms alert you when loss of power is imminent, and on-screen
capacity gauges on the transport monitor indicate battery charge condition and
capacity.
The Lithium-Ion battery is a rechargeable battery containing Lithium-Ion cells. Each
battery contains an integrated electronic fuel gauge and a safety protection circuit.
The processor within the equipment communicates with both the battery and the
charger.
Docking stations
There are three versions of docking stations:
● Bedside Dock for use with the Solar 8000M/I patient monitor.
The Bedside Dock mounts the PDM to a bedside monitor. The Bedside Dock has
a host interface connection which delivers power, provides communication and
allows easy connection with a bedside monitor.
● Mini Dock for use with mounting hardware.
The Mini Dock provides a mechanical connection between the PDM and mounting
hardware. There are no electrical connections on the Mini Dock.
● Transport Dock for use with the Transport Pro patient monitor.
The Transport Dock fastens to the back of the transport monitor and delivers
power, provides communication and allows easy connection and disconnection.
Measurement principle
The PDM is a portable acquisition device. It collects data from a patient, converts the
data to a digital form for processing, and sends the data to a bedside, transport or
surgical monitor for further processing and display.
The data that it collects, converts, and sends includes the patient’s vital signs and
physiological waveforms. It also stores patient history including trends and special
events, and setup information such as blood pressure zero points and alarm limit
settings. The patient history is stored so that the collected information is transferred
with the PDM when a patient is transferred to a different monitor.
Equipment symbols
The following symbols appear on one or more of the devices.
Battery (PDM).
Communication.

Module introduction
Power indicator.
(black or red)
Zero all.
ePort connection.
Degree of ingress protection.

Degree of protection against harmful ingress of water:
Components not marked with an IPX n code are rated as
Ordinary (no protection against fluid ingress). All other IPXn rated
components have the degree of protection per the ‘n’ rating.
IPX1: This equipment is protected against harmful effects of
dripping water per IEC 60529.
Defib/Sync Defibrillator synchronization connector (PDM).
Date of manufacture. This symbol indicates the date of
manufacture of this device. The first four digits identify the year,
the following two digits identify the month, and, if indicated, the
last two digits identify the day.
Manufacturer name and address.
Catalogue or orderable part number.
Device serial number.
Every device has a unique marking for identification. The UDI

marking appears on the device label.
Atmospheric pressure limitations.
Temperature limitations.
Humidity limitations.
This symbol indicates that the waste of electrical and electronic

equipment must not be disposed as unsorted municipal waste
and must be collected separately. Please contact an authorized
representative of the manufacturer for information concerning
the decommissioning of your equipment.
Recycled materials or may be recycled.

Module introduction
Recyclable Lithium-Ion.
European authorized representative.
European Union Conformity Mark
India only. Indian Conformity Assessment Certification granted

by the Bureau of Indian Standards.
CAUTION U.S. Federal law restricts this device to

sale by or on the order of a physician.
Underwriters Laboratories product certification mark.

MEDICAL – PATIENT – MONITORING EQUIPMENT AS TO
ELECTRICAL SHOCK, FIRE AND MECHANICAL HAZARDS ONLY
E348644 IN ACCORDANCE WITH ANSI/AAMI ES60601-1 (2005) + AMD 1
(2012, CAN/CSA-C22.2 No. 60601-1 (2014), IEC 60601-1-6, IEC
60601-2-27, IEC 80601-2-30, IEC 60601-2-34, IEC 60601-2-49,
ISO 80601-2-56, AND ISO 80601-2-61.
Service information
Service requirements
Follow the service requirements listed below.
WARNING Failure on the part of all responsible individuals, hospitals or
institutions, employing the use of this device, to implement the
recommended maintenance schedule may cause equipment
failure and possible health hazards. The manufacturer
does not, in any manner, assume the responsibility for
performing the recommended maintenance schedule,
unless an Equipment Maintenance Agreement exists. The
sole responsibility rests with the individuals, hospitals, or
institutions utilizing the device.
CAUTION DISPOSAL. At the end of its service life, the product described
in this manual, as well as its accessories, must be disposed of
in compliance with the guidelines regulating the disposal of
each product. If you have any questions concerning disposal
of a product, please contact GE or its representatives.
● Refer servicing of the equipment to qualified service personnel only. Service

personnel servicing this product must have an appropriate technical qualification,
or equivalent work experience, and be familiar with the service requirements
described in this manual and in any related service documentation. Service training
for the product is recommended.
● Any unauthorized attempt to repair equipment under warranty voids that warranty.

Module introduction
● It is the user's responsibility to report the need for service to GE or to one of their
authorized agents.
● Regular maintenance, irrespective of usage, is essential to ensure that the
equipment will always be functional when required.
Unique Device Identifier (UDI)

Unique Device Identifier. (UDI)
Every medical device has a unique marking for identification.
The UDI marking appears on the device labeling.
Note that this is only an example of a UDI marking. The
device may have a linear barcode as in this example, or a
DataMatrix code, or only alphanumeric identifiers with no
barcode. Also the identifiers vary per product.
The characters used in the UDI marking represent specific identifiers. In the example above:
Device identifiers:
● (01) = GS1 global trade item number (GTIN) of the device.
● 1234567891234 = Global trade item number.
Production identifiers:
● (21) = GS1 application identifier for the serial number of the device.
● SJN14241237HA = Serial number.
● (11) = GS1 application identifier for the manufacturing date of the device.
● 150628 = Manufacturing date: year,month,day (YYMMDD).
Note that for some product types the production identifiers can have other elements instead of the ones
listed above:
● (10) = GS1 application identifier for the batch or lot number, followed by the batch or lot number.
● (17) = GS1 application identifier for the expiration date of the device, followed by the expiration date.
In addition to the UDI marking, also note the following:

Date of manufacturing. This symbol indicates the date of
manufacturing of the device. The first four digits identify the
year, the following two digits identify the month, and the last
two digits identify the day.
Equipment identification
Every GE device has a unique serial number for identification. The serial number is
written in a device label.
The product code for the PDM is SPX.

Module introduction
1 Product code
2 Year manufactured
3 Fiscal week manufactured
4 Production sequence number
5 Manufacturing site
6 Miscellaneous characteristic

Module introduction

Service tool and configuration
4
PDM Service Tool interface
The PDM Service Tool interface is a PC-based application used to calibrate, configure,
troubleshoot and view or print PDM service information when the PDM is not in clinical
use.
The PDM Service Tool interface is password protected and can be accessed locally
when a PDM and a service computer are connected to the Solar 8000M/I patient
monitor or the PDM Service Adapter.
Equipment required to use the PDM Service Tool

The following equipment is required to use the PDM Service Tool with a Solar 8000M/I
patient monitor.
● PC with Microsoft Windows 7 operating system, CD drive, and a network card
● Category 5 crossover cable (PN 415480-001)
● ePort host interface cable (PN 2017098-001)
● Solar 8000M/i patient monitor with PDM service adapter (PN 2028845-002)
● PDM software CD with PDM Service Tool
The following equipment is required to use the PDM Service Tool without a host
monitor.
● PDM Service Tool Kit
￭ 2030924–003 (with power supply)
￭ 2030924–004 (without power supply)
PC connections and setup

Connecting the PDM and service computer to the Solar
8000M/I patient monitor
The PDM requires a stable power source and communication interface to the service
computer before you can log onto the PDM Service Tool.

1. Connect the category 5 crossover cable between the service computer’s network
port and the PDM service adapter.
2. Connect the ePort host interface cable between the ePort connector on the PDM
and the ePort connector on the PDM service adapter.
3. If present, remove the PDM battery.
4. Power on the service computer.
5. Power on the Solar 8000M/I patient monitor if it is not already powered on.
The ePort host interface cable connected to the monitor provides the necessary
power to the PDM.
Connecting the PDM and service computer to the PDM

service adapter
The PDM requires a stable power source and communication interface to the service
computer before you can log onto the PDM Service Tool.

1. Connect the category 5 crossover cable between the service computer’s network
port and the PDM service adapter.
2. Connect the ePort host interface cable between the ePort connector on the PDM
and the ePort connector on the PDM service adapter.
3. Connect the external power supply to the PDM service adapter.
4. If present, remove the PDM battery.
6. Plug the external power supply’s power cable into a power outlet.
Changing the IP address on a Windows 7 service computer

Before changing the service computer’s IP address, you must first disable all network
ports on the service computer except the PDM connection.
2. Open a command prompt window and make note of the service computer’s IP
address, subnet mask, and default gateway:
a. From the Windows toolbar, select the Start menu > All Programs >
Accessories.
b. Select Command Prompt.
c. Enter ipconfig<space>/all and press Enter.
d. If present, note the IP address, subnet mask and default gateway.

3. Change the service computer’s network properties:

a. Open theNetwork and Sharing Center.
b. From View your active networks, select Local Area Connection > Properties.
c. Select the appropriate internet protocol (e.g., Internet Protocol Version
TCP/IPv4).
d. Select Use the following IP address and complete the following steps:
i. In the IP address field, enter 192.168.252.95.
ii. In the Subnet mask field, enter 255.255.255.0.
iii. Select OK.
4. Close all open windows.
Disabling the firewall or networking services on a Windows

7 service computer
If the service computer is running any firewall protection or networking services
(including wireless network cards), these services may need to be disabled. Contact
your IT department for assistance.
Logging on to the PDM Service Tool from

Windows 7
Before you can logon to the PDM Service Tool, you must first complete the following
tasks in the order presented:
● Connect the PDM and service computer to a Solar 8000M/I patient monitor or
PDM Service Adapter.
● Change the IP address on the service computer.
● Disable the firewall and networking services on the service computer.
1. Power on the service computer, if not already powered on.
2. From the Windows toolbar, select the Start menu.
3. Select All Programs > GE Healthcare > PDM Version x.x > PDM Version x.x.
4. Enter the username and password and select Login or press Enter.
Username: biomed
Password: Change Me
NOTE
The password “Change Me” contains two words, separated with one space.
Username and password are case sensitive. Username and password cannot
be created, edited, or deleted.
PDM Service Tool modules

The PDM Service Tool provides Information, Configuration, Diagnostics, and
Calibration modules for servicing and configuring the PDM.

To view a basic description of each module, select Help > Help from the PDM Service
Tool module toolbar to launch the Help file.
NOTE Some information displayed in a PDM Service Tool module is
updated in 30–second intervals.
Information module
From the PDM Service Tool Information module, you can select the Device
Information page to display general PDM information and the date and times when
the last calibration was performed for NBP, analog out IP, and analog out ECG.
Viewing PDM Device Information

2. Log onto the PDM Service Tool.
3. Select Information > Device Information.
Printing PDM Device Information

1. Connect the service computer to a parallel printer or enable a network port that
has connectivity to a network printer.
4. Select Information > Device Information.
5. Select File > Print.
6. After printing is finished, disconnect or disable the network port used for printing.
Removing connectivity to the network port prevents inadvertent access to the
PDM.
Configuration module
From the PDM Service Tool Configuration module, you can select the Asset Settings,
ECG Filter Config., Licensing, and Software Transferpages to view and configure
PDM module settings.

Asset Settings
The Asset Settings page displays the PDM serial number and the user assigned asset
number.
Entering the PDM serial number
The serial number must follow the specific format found on the PDM serial number
label.
The PDM serial number must be changed if the main board is replaced.
2. Select Configuration > Asset Settings,
3. Enter the PDM serial number and select Submit.
Entering the PDM asset number
The user assigned asset number can be up to 13 alphanumeric characters.
2. Select Configuration > Asset Settings.
3. Enter the user assigned asset number and select Submit.
ECG Filter Config page

The ECG Filter Config page allows configuration of the power frequency and ECG filter.
NOTE The power frequency of the PDM must match the power
frequency of the host patient monitor.
The ECG filter is always enabled, but may be temporarily disabled. The ECG filter will
always default to Enabled after a power cycle or reboot.
CAUTION Do not disable ECG Filter during clinical use.

Licensing
The Licensing page allows activation and removal of license(s). To obtain a license,
contact GE Service and provide the PDM serial number and MAC address.
Activating or removing Licenses
A new license activation code must be requested and entered if the main board is
replaced. Contact GE Service to request a new activation code.
2. Select Configuration > Licensing.
3. To activate a license, complete the following procedure:
a. Enter the license activation code and select Actvate.
b. After activating license, perform the checkout procedures provided in the
host patient monitor service manual.
4. To remove a license, select Remove.
Software Transfer
The Software Transfer page is used for installing PDM software. Follow the
instructions on the screen.
To power cycle the PDM , disconnect and reconnect the ePort host interface connector.
CAUTION Do not disconnect the power during software transfer. The
Patient Data Module could be damaged.
NOTE After installation, perform the checkout procedures provided

in the host patient monitor service manual.
Diagnostics module
From the PDM Service Tool Diagnostics module, you can select the Log Files and
Service Metrics pages.
Downloading or viewing log files

Log files contain messages and errors that may be used for troubleshooting problems.
2. Select Diagnostics > Log Files.
3. To download log files, select Download Log.
4. To view log files, select View Log.
Viewing PDM service metrics

If a Service Metrics value falls outside of specification, the data field will be highlighted
red. Contact GE Service.
NOTE Some PDM statistics update every 30 seconds.
PDM service statistics can be used to troubleshoot problems and to track NBP useage.

If the NBP pump assembly is replaced, clear all NBP statistics

2. Select Diagnostics > Service Metrics.
3. To view the NBP usage statistics, complete the following steps:
a. Select NBP STATISTICS to view the data.
b. To clear all NBP statistics simultaneously and start collecting new statistics,
select REFRESH ALL.
c. To individually clear and start collecting a new NBP statistic, select the desired
NBP statistic:
● NBP Pump Run time
● NBP Deflate Valve Cycle Count
● NBP Dump Valve Cycle Count
● NBP Pump Cycle Count
Analog outputs calibration

Analog outputs calibration shall be performed:
● If the main board is replaced.
● If the measured value is not within the specification limits.
Required tools for analog output calibration

NOTE Use only accurate, properly maintained, calibrated, and
traceable calibration tools for the parameter calibration to
ensure measurement accuracy.
● Unterminated defib sync cable (2017842-001)

● Digital voltmeter
Making connections for analog outputs calibration

2. Disconnect all parameter cables.
3. Make sure the power indicator on the module is ON (green).
4. Connect the unterminated cable to the Defib/ Sync connector on the module.
5. From the service computer, select Calibration > Start Calibration and follow the
instructions displayed on the screen.
Calibrating analog outputs

Calibrating analog outputs is required after the main board is replaced.
NOTE To end the analog out calibration at any time with out making
any changes, select Stop Calibration.

1. Calibrate ECG analog output:

a. Use the digital voltmeter to measure the DC voltages across the following
unterminated cable:
Wire color Signal name Digital voltmeter
Brown ECG_ANALOG_OUT POSITIVE
Green ANALOG_RETURN GROUND
b. On the service laptop, enter the measured voltage.

c. Select OK to confirm and save the measured voltage.
2. Calibrate the invasive pressure analog output:
a. Use the digital voltmeter to measure the DC voltages across the following
unterminated cable:
Wire color Signal name Digital voltmeter
Red BP_ANALOG_OUT POSITIVE
Green ANALOG_RETURN GROUND
b. On the service laptop, enter the measured voltage.

c. Select OK to confirm and save the measured voltage.
3. Perform the functional check to test the analog output and defibrillator
synchronization marker out signals provided in the Solar 8000M/I Patient Monitor
Service Manual.


Installation
5
Unpacking
WARNING EXCESSIVE LEAKAGE CURRENT. If the device has been
transported or stored outside operating temperature range
allow it to stabilize back to operating temperature range
before removing it from the plastic bag and connecting it to
the power line.
CAUTION PACKAGING DISPOSAL. Dispose of the packaging material,

observing the applicable waste control regulations.
1. Confirm that the packing box is undamaged. If the box is damaged, contact the
shipper.
2. Open the top of the box and carefully unpack all components.
3. Confirm that all components are undamaged. If any of the components is
damaged, contact the shipper.
4. Confirm that all components are included. If any of the components is missing,
contact your GE distributor.
Inspecting the PDM equipment before

installation
Inspect the equipment and its components carefully before installation. Do not use
damaged equipment. If any equipment is damaged, contact GE Service.
1. Check the received equipment against the sales order.
2. Unpack the equipment from the shipping box.
3. Inspect the equipment for damaged or missing components:
a. Inspect the case for cracks or other physical damage.
b. Inspect cables for fraying or other damage.
c. Inspect all plugs and connectors for bent pins or other damage.
d. Check for loose or missing screws on the mounting hardware.
4. Replace all damaged or missing components.

Installation
5. Check that the PDM is labeled and configured according to the shipping box and
sales order.
a. Check that the PDM serial number matches the serial number printed on the
shipping box.
b. Check that the PDM SpO2 label matches the SpO2 technology listed in the
sales order.
The SpO2 technology is printed on the front PDM label, located above the
blue SpO2 connector. The label will display Masimo SET for Masimo SpO2
technology or Nellcor Oxi/Max for Nellcor SpO2 technology.
c. If the invasive pressure channels are disabled, check that the parameter caps
are installed over the invasive pressure ports.
Installing batteries
WARNING EXPLOSION HAZARD. Do not incinerate a battery or store at
high temperatures. Serious injury or death could result.
Testing the battery charge

Before installing a battery, verify the battery’s state of charge. Each battery must be
fully charged before use.
1. Press the TEST button on the battery and check the green charging level indicators
to see how much charge is left:
● Four LEDs illuminated: 75% to 100% of full-charge capacity.
● Three LEDs illuminated: 50% to 74.9% of full-charge capacity.
● Two LEDs illuminated: 25% to 49.9% of full-charge capacity.
● One LED illuminated: 10% to 24.9% of full-charge capacity.
● One LED flashing: < 10% of full-charge capacity.
Replacing the PDM battery

WARNING EXPLOSION OR FIRE. Using non-recommended batteries
could result in injury/burns to the patients or users. Only use
batteries recommended or manufactured by GE. The warranty
can be voided if non-recommended batteries are used.
WARNING EXPLOSION HAZARD. Do not incinerate the battery or store at


Installation
1. Open the battery door by gently pulling on the battery door pull tab.
2. Pull the battery tray out of the module using the battery tray strap and remove
the battery from the tray.
3. Insert a new battery with the test button facing up and the arrow pointing into
the module.
4. Press the battery door closed until it seals the battery compartment.
WARNING PHYSICAL INJURY. Do not install the device above a
patient. Make sure the battery is completely inserted
and the battery door is completely closed. Falling
batteries could seriously or fatally injure neonatal or other
vulnerable patients.
5. Press the Power button on the PDM.

6. Check that the Power LED illuminates amber while the PDM boots up, then
illuminates green.

Installation
PDM software
The PDM leaves the factory with software installed. If you need to install the software,
contact your local GE representative.
Mounting options
WARNING For safety reasons, all connectors for patient cables
and sensor leads are designed to prevent inadvertent
disconnection, should someone pull on the leads. Do not route
cables in a way that they may present a stumbling hazard.
WARNING Do not hang articles on the IV pole that are not related to the
PDM’s use.
Do not place the PDM more than 147 cm (58 in) from the floor
when mounting on an IV pole with a base not less than 58
cm (23 in) in diameter.
WARNING PHYSICAL INJURY. Take care when mounting devices to an IV

pole. If a device is mounted too high the IV pole may become
unbalanced and tip over.
WARNING To avoid accidental ingress of liquids, do not tilt the PDM in

any direction or mount the PDM in a vertical position with the
patient cables facing up or down.
Mounting options include mounting to a bed headboard or footboard, an IV pole, or

a roll stand using one of the docking stations. Mounting kits include all necessary
hardware and installation instructions.

Installation
Mounting points to note

● Before docking the PDM to the Bedside Dock, Transport Dock or Mini Dock, be sure
that the PDM rails are aligned with the docking station rails. Shown below are the
PDM rails engaged with the Mini Dock rails:
● Be sure that the PDM is mounted at a convenient height, allowing all users to align
the PDM rails with the Bedside Dock rails, as shown:

Installation
● The PDM can be mounted using the Mini Dock (P/N 2021968-001), shown here
with the L-bracket (P/N 2021967-001):
● An ePort host interface cable can be connected directly to the PDM as shown here:
Connecting to bedside monitor

If using the PDM with a bedside monitor:
1. Connect one end of the ePort host interface cable to the PDM ePort connector.
● 5 ft (P/N 2017098-001)
● 15 ft (P/N 2017098-003)
● 25 ft (P/N 2017098-005)
2. Connect the other end of the ePort host interface cable to the PDM adapter on
the back of the host patient monitor.
The bedside dock (P/N 2030340-002) can be positioned using various mounts.
Horizontal mounting of the bedside dock is recommended, as shown using the
L-bracket (P/N 2021967- 001). The ePort host interface cable is used to connect the
bedside dock to the host patient monitor.

Installation
Connecting the PDM to a transport monitor

The PDM can be connected to a Transport Pro patient monitor for the display of
patient data and for extending PDM battery charge capacity during transport.
1. To connect the PDM to the Transport Dock (PN 2030341–001), complete the
following steps:
a. Guide the mounting rails of the PDM onto the Transport Dock mounting rails.
b. Slide the PDM toward the Transport Dock ePort connector until the locking key
secures the PDM to the Transport Dock.
The following figure shows the PDM docked to the Transport Pro patient
monitor.

Installation
2. To connect the PDM to the Transport Dock using the ePort host cable, connect
the ePort host cable to the PDM ePort connector and to the Transport Dock ePort
connector as shown.
NOTE The orderable part numbers for the ePort host interface
cable are as follows:
● ePort host interface cable, 2.5 feet long, PN
2017099–001.
● ePort host interface cable, 12 feet long, PN
2017099–003.
Performing an admit/discharge cycle on the PDM

Prior to patient use, perform an admit/discharge cycle on the PDM to clear all patient
data. Refer to the monitor’s operator manual for instructions.
CAUTION DISCHARGE TO CLEAR PATIENT DATA. When admitting

a new patient/starting a new case, you must clear all
previous patient data from the system. To accomplish
this, be sure the acquisition module is securely mounted,
disconnect the patient cables, then discharge the previous
patient/end the case.

Installation
Installation check procedure

The purpose of the installation check is to ensure that the system is properly installed
and configured for use.
Service personnel shall perform the following checkout procedure for the monitoring
system after the hardware installation and platform configuration is completed:
● Visual inspection
● Electrical safety test
NOTE The manufacturer has performed the electrical safety
test for the patient monitor and acquisition modules
during final inspection. You do not have to perform the
electrical safety tests during installation checkout, if there
is less than 12 months since the patient monitor was
manufactured. Check the manufacturing week and year
from the device plate.
● Functional check
Performing visual inspection

1. Remove the module and check that:
a. The front cover is intact.
b. All connectors are intact, clean and attached properly.
c. The module casing and the latch are clean and intact.
d. The patient cables are clean and intact.
Checking that the battery indicator displays

Check that the battery indicator displays on the monitor without displaying any
battery errors.
PDM parameter checkout tests using a Solar 8000M/I

patient monitor
The PDM must be connected to a Solar 8000M/I patient monitor to complete the
parameter checkout tests. See the Solar 8000M/I Patient Monitor Service Manual,
Maintenance and checkout chapter for complete checkout procedures.
Complete the following checkout tests.
1. Check that the ECG parameter functions per the customer configuration.
a. Connect the PDM to the monitor.
b. Connect the PDM to a patient simulator.
c. Confirm that the ECG waveforms display on the monitor.

Installation
2. Check that the invasive blood pressure parameter functions.

b. Connect the PDM to a patient simulator.
c. Zero the pressure and select dynamic waveform.
d. Confirm that a waveform is displayed on the monitor.
e. Repeat to check all enabled invasive pressure channels.
3. Check that the temperature parameter functions.
b. Connect the PDM to a patient simulator, connect a temperature adapter, and
select a known temperature value.
c. Confirm that the value displayed on the monitor is within the output range
specified in the temperature technical specifications.
4. Check that the SpO2 parameter functions.
a. Follow the SpO2 parameter checkout procedure in the Solar 8000M/I Patient
Monitor Service Manual, Maintenance and checkout chapter.
b. Use the appropriate test for your PDM SpO2 technology.
The SpO2 technology is printed on the front PDM label, located above the
blue SpO2 connector. The label will display Masimo SET for Masimo SpO2
technology or Nellcor Oxi/Max for Nellcor SpO2 technology.

Planned and corrective maintenance
6
About the maintenance check procedures
This chapter describes the planned and corrective maintenance check procedures
for the product. To help ensure the equipment remains in proper operational and
functional order and maintains its essential performance and basic safety, follow the
corrective and planned maintenance recommendations. The tests that are related to
the essential performance and basic safety are marked with the *.
The cleaning precautions, cleaning requirements, cleaning procedures, and
recommended cleaning solutions are described in the monitor’s user manual.
For details about cleaning, disinfecting and sterilizing the accessories, see the
instructions for use in the accessory package.
Record the results of the planned and the corrective maintenance check procedures
in the check form provided in this manual.
CAUTION Make sure the patient is disconnected from the monitor before
performing any service on the device.
Manufacturer responsibility
WARNING Failure on the part of all responsible individuals, hospitals or
institutions, employing the use of this device, to implement the
recommended maintenance schedule may cause equipment
failure and possible health hazards. The manufacturer
does not, in any manner, assume the responsibility for
performing the recommended maintenance schedule,
unless an Equipment Maintenance Agreement exists. The
sole responsibility rests with the individuals, hospitals, or
institutions utilizing the device.
Corrective maintenance
Perform the following check procedure after any corrective maintenance, before
taking the product back into clinical use:
See the Solar 8000M/I Patient Monitor Service Manual to complete the following
procedures:
● Checkout procedures
● Electrical safety tests
● NBP calibration

● Defib/Sync analog output test using an oscilloscope

See this manual to complete the following procedures:
● Analog output calibration procedure
● Defib/Sync analog output test using the GE Analog Out/Defib Sync Tester
Required checkout procedure
Performed service
activity Visual inspections Electrical safety test Functional check
Product casing All steps All steps Checkout
opened either for procedures:
troubleshooting
● Parameter tests
purpose or for
replacing any of ● NIBP calibration
the internal parts.
● Defib/sync and
analog output
test
Main board All steps All steps Checkout
procedures:
● Parameter tests
● NIBP calibration
● Defib/sync and
analog output
test
Calibration
procedure:
● Analog outputs
calibration
Top housing All steps All steps Not applicable
● Battery, battery All steps Not applicable Not applicable
door, or battery
tray replaced.
● Product labels
or other external
part replaced.
Planned maintenance
Perform the planned maintenance procedure completely every 12 months after
installation. Perform the procedure in the following order:
1. Visual inspection
2. Electrical safety test
3. Functional check
4. Battery maintenance

Performing visual inspection

Performing electrical safety tests *

Perform the electrical safety tests described in the monitor’s service manual, Checkout
procedures chapter. Perform the following tests:
1. Patient (source) leakage current test
2. Patient (sink) leakage current test
Performing functional check for PDM

Note that the temperature and cardiac output measurement share the same
hardware circuitry. A separate test procedure for cardiac output is not necessary.
See the Solar 8000M/I Patient Monitor Service Manual to complete the following
procedures:
● Checkout procedures
● Electrical safety tests
● NBP calibration
● Defib/Sync analog output test using an oscilloscope
See this manual to complete the following procedures:
● Analog output calibration procedure
● Defib/Sync analog output test using the GE Analog Out/Defib Sync Tester
● Battery maintenance
Functional check for Defib/Sync analog outputs

Complete the following procedure to test the Defib/Sync analog outputs using a GE
Analog Out/Defib Sync Tester and Solar 8000 M/I patient monitor.
WARNING PATIENT RISK HAZARD. Never use the Analog Out/Defib Sync
Tester while the monitor is connected to a patient.
Required tools
The following tools are required for Defib/Sync analog outputs:
● GE Analog Out/Defib Sync Tester, GE PN2040582-001
● Analog output/Defib sync cable for the module you are testing. It is recommended
that you strip the ends of the unterminated analog output cable and tin the ends
with a soldering Iron.

● A multiparameter patient simulator that supports the ECG and invasive pressure
measurements. The multiparameter patient simulator may have to be isolated
from ground or run on battery power to eliminate noise while doing this test.
● Invasive BP patient cable
● 5-lead ECG patient cable and leadwires
Connections
1. Make the connections for Defib/Sync analog outputs as follows:
For ECG:
● Connect the 5-lead ECG cable to the module’s ECG connector and the ECG
leadwires to the simulator.
For invasive pressure:
● Connect the invasive pressure cable to the module’s invasive pressure
connector and to the simulator.
Monitor configuration
Refer to the monitor’s user manual for configuration information and the simulator’s
documentation for how to use and configure the simulator.
1. Configure the monitor for Defib/Sync analog outputs as follows:
For ECG:
● If the second ECG waveform displayed on the monitor is not the V Lead, set
the second waveform to the V Lead.
● Zero the invasive pressure on the simulator and on the monitor.
● P1 ART1 scale: 160 kPa.
Simulator configuration
For instructions on how to use and configure the simulator, refer to the documentation
provided with the simulator.
1. Configure the simulator for Defib/Sync analog outputs as follows::
For ECG:
● ECG rhythm: a normal sinus rhythm
● Heart rate: 80–90 bpm
● BP: ART waveform
Analog output and defibrillator synchronization marker out

signals tests
1. Connect analog output/Defib sync cable to the module’s Defib/Sync connector.
2. Connect the bare wires of the analog output/Defib sync cable to their
corresponding connections in the tester:
a. Connect the green wire (ANALOG_RETURN) from the analog output/Defib sync
cable to the tester’s ground terminal (GND).

b. Connect the gray wire (DEFIB_SYNC_MARKER_OUT) ) from the analog

output/Defib sync cable to the tester’s Mark connector.
c. Connect the brown wire (ECG_ANALOG_OUT) from the analog output/Defib
sync cable to the tester’s ECG connector.
d. Connect the red wire (BP_ANALOG_OUT) from the analog output/Defib sync
cable to the tester’s BP connector.
PDM analog output/Defib sync cable
Wire color Signal name
Brown ECG_ANALOG_OUT
Red BP_ANALOG_OUT
Orange NO_CONNECTION
Yellow MARKER_RETURN
Shield DRAIN WIRE
Green ANALOG_RETURN
Blue NO_CONNECTION
Violet DEFIB_SYNC_MARKER_IN
Gray DEFIB_SYNC_MARKER_OUT
3. Plug the RL ground cable from the tester into the simulator’s RL terminal and
connect the patient leadwire to the simulator’s RL terminal.
4. Disconnect the V lead of the patient cable from the simulator and connect it to the
V LEAD terminal of the tester.
5. Test ECG:
a. Set the tester selector switch to ECG.
b. On the monitor, observe that the V lead waveform resembles the primary
ECG waveform.
6. Test BP:
a. Set the tester selector switch to BP.
b. On the monitor, observe that the V lead waveform resembles the BP waveform.
7. Test Marker Out:
a. Set the tester selector switch to MARK.
b. On the monitor observe that the V lead waveform has a marker pulse
corresponding to the R wave of the primary ECG waveform.
8. Test Marker In:
a. Set the tester selector switch to ECG.
b. Connect the violet wire (DEFIB_SYNC_MARKER_IN) and the gray wire
(DEFIB_SYNC_MARKER_OUT) of the analog output/Defib sync cable to the
tester’s Mark connector.
c. On the monitor, observe the negative spikes in the R-waves of the displayed
ECG waveform:
i. Observe normal R-waves (1) before shorting Marker Out and Marker In.

ii. Observe negative spikes in the R-waves (2) after shorting Marker Out
and Marker In. Note that the spikes are small, and can be difficult to see
at times.
If the test fails, calibrate analog outputs and re-test. If the test continues to fail,
replace the main board.
Maintaining the battery

About the lithium-ion battery
The lithium-ion (Li-Ion) battery is a rechargeable battery containing lithium-ion cells.
Each battery contains an integrated electronic fuel gauge and a safety protection
circuit.
● The battery discharges on its own, even when it is not installed in the equipment.
This discharge is the result of the lithium-ion cells and the bias current required
for the integrated electronics.
● The self-discharge rate of lithium-ion cells double for every 10°C (18°F) rise in
temperature.
● The capacity loss of the battery degrades significantly at higher temperatures.
● As the battery ages, the full-charge capacity of the battery degrades and is
permanently lost. As a result, the amount of charge that is stored and available
for use is reduced.
The following terms are used to define the battery capacity:
● Design The rated/minimum capacity of the battery cells when the battery is new.
capacity
● Full-charge The actual amount of charge the battery can store and deliver.
capacity
● Remaining The amount of full-charge capacity currently remaining in the battery.
charge This is a percent of full-charge capacity.
capacity
Improving battery performance

Follow these guidelines to improve the battery performance:
1. Position the equipment in a location that does not artificially increase the
operating temperature of the battery.
2. GE recommends using an approved GE external battery charger to charge the
battery whenever possible. The external battery charger maintains a lower
battery cell temperature during the charge cycle.
This reduction in temperature can extend the life of the battery.

3. Condition the battery when the Battery Quality status indicates that battery
conditioning is needed (Monitor Setup > Main Setup > Battery Status > PDM >
Battery Quality > Condition).
Battery conditioning re-calibrates the electronic fuel gauge. GE recommends
using an external battery charger to condition the battery.
See the supplemental information manual for details about a compatible external
battery charger.
Battery storage recommendations

GE recommends storing the battery outside of the device at a temperature between
20°C to 25°C (68°F to 77°F) if the device will not be used for a long period of time.
Testing the battery charge

Before installing a battery, verify the battery’s state of charge. Each battery must be
fully charged before use.
1. Press the TEST button on the battery and check the green charging level indicators
to see how much charge is left:
● Four LEDs illuminated: 75% to 100% of full-charge capacity.
● Three LEDs illuminated: 50% to 74.9% of full-charge capacity.
● Two LEDs illuminated: 25% to 49.9% of full-charge capacity.
● One LED illuminated: 10% to 24.9% of full-charge capacity.
● One LED flashing: < 10% of full-charge capacity.
Charging a battery inside the module

The module battery is charged whenever the module is installed into a monitor and
the monitor is connected to an AC power source. The module battery is charging both
when the monitor is turned on and when the monitor is in the standby mode.
There are some special conditions when the module battery charging is temporarily
denied, for example, when the battery temperature is too high, or while the monitor
battery is being charged.
Charging a battery using an external battery charger

See the supplemental information manual for details about an approved GE external
battery charger.
Follow the external battery charger instructions for use to charge the battery.
Conditioning the battery

Battery conditioning re-calibrates the electronic fuel gauge. GE recommends using an
external battery charger to condition the battery. See the supplemental information
manual for details about an approved GE external battery charger.
Condition the battery when the Battery Quality status indicates that battery
conditioning is needed:
1. Select Monitor Setup > Main Setup > Battery Status > PDM.

2. Next to Battery Quality, check for a Condition status.

A Condition status means that the battery requires conditioning.
3. Follow the external battery charger instructions for use to condition the battery.


the module.


illuminates green.
Battery recycling
This product contains Lithium-Ion batteries. At the end of their service life, batteries
in this product must be recycled or disposed in accordance with local or national
regulations. Do not dispose of batteries as trash or unsorted municipal waste.
Requirements and services for recycling of batteries vary between countries.
● USA: You may follow the battery manufacturers instructions on the battery to
recycle it. Alternatively, you may return GE product batteries to GE for recycling.
For information about returning batteries to GE, contact your authorized GE Service
representative or contact GE Equipment Services at 1-800-437-1171.
● Canada: Contact the approved battery stewardship program in your province for
information on recycling your batteries.
● Other countries: Recycle batteries through your local, regional or national collective
scheme in accordance with your local or national regulations.


Troubleshooting
7
Troubleshooting guidelines
CAUTION Make sure the patient is disconnected from the monitor before
performing any service on the device.
This chapter focuses on troubleshooting technical problems. Refer to the user manual
for troubleshooting monitoring problems and clinical configuration issues.
If a problem remains, contact technical support for service. To ensure accurate
problem solving, please be prepared to provide the following information:
● Product name and serial number or UDI
● Hardware and software versions
● Detailed problem description
● Error messages, if any
● Configuration information (or settings file)
● Service Logs
● The troubleshooting you have done so far
Perform the specified corrective maintenance check after any corrective maintenance
to the product.
Performing visual inspection for the PDM

Before any detailed troubleshooting, complete a thorough visual inspection for the
module.
2. If you suspect that there are loose parts or cable connections inside the PDM,
remove the battery, pull tab, mount rail, and the top housing, and check that:
a. All the screws are tightened properly.
b. All cables are connected properly.
c. There are no loose objects inside the module.

Troubleshooting
Troubleshooting module functionality

Follow these instructions to identify the component causing the functional problem.
Before you begin, ensure that the monitor is turned on, and the module is connected.
1. Check if there are any error messages shown in the message field.
For a list of possible causes and solutions, see PDM error messages.
2. Check the compatibility of each system component.
For a list of the compatible monitors, modules, and accessories, see the
supplemental information manual.
3. Check that there are no identical modules connected to the monitor.
For a list of identical modules, see the supplemental information manual.
4. Visually check the accessories in use. Replace them, if necessary.
For a list of compatible accessories, see the supplemental information manual.
5. Connect the accessories with a simulator to the module. Check that the
parameters measured by the module are configured to the display with adequate
priority.
6. Press one of the module keys.
7. Check that the correct menu opens or the activity starts. If nothing happens,
check if there are other problems with the module.
PDM error messages

The following error messages display at the monitor if there is a serious problem
with the PDM.
Message Probable cause Recommended action
BATTERY FAIL The battery is faulty See Troubleshooting the battery.
COMMUNICATION FAILURE ● PDM is not properly connected ● Disconnect and reconnect the
to the monitor. PDM.
ePort host interface cable or the
● See Troubleshooting the loss of
module is damaged.
communication.
● Solar 8000M/I patient monitor
● See Troubleshooting Solar
may have incompatible
8000M/I patient monitor
hardware or software.
CONNECTING messages.
CONNECTING ● PDM is not properly connected ● Disconnect and reconnect the
to the monitor. PDM.
● ePort host interface cable or the ● See Troubleshooting the loss of
module is damaged. communication.
● Solar 8000M/I patient monitor ● See Troubleshooting Solar
may have incompatible 8000M/I patient monitor
hardware or software. CONNECTING messages.
Service the PDM - Error Code The data in secure storage is Replace the main board and
0xPDM1000 corrupt. reinstall the software.

Troubleshooting

Service the PDM - Error Code One or more of the PDM’s flash file Replace the main board and
0xPDM1001 system partitions is full. reinstall the software.
Service the PDM - Error Code An error occurred writing data to Replace the main board and
0xPDM1002 secure storage. reinstall the software.
Service the PDM - Error Code An error occurred writing to the SPI Replace the main board and
0xPDM1003 bus. reinstall the software.
Service the PDM - Error Code An error occurred reading the Replace the main board and
0xPDM1004 network interface information. reinstall the software.
Service the PDM - Error Code An error occurred reading flash file An error occurred reading flash file
0xPDM1005 system partition information. system partition information.
Service the PDM - Error Code An error occurred using the TWI Replace the main board and
0xPDM1006 bus. reinstall the software.
Service the PDM - Configure Power line frequency could not be Reapply the power frequency.
Power Frequency read from secure storage using
default.
Service the PDM - Install License Purchased option count could not Reinstall the license.
be read from secure storage using
default.
Service the PDM - Calibrate NIBP NIBP calibration values could not Perform NIBP calibration.
be read from secure storage using
defaults.
Service the PDM - Calibrate ECG ECG analog out calibration values Perform analog out ECG calibration.
Analog Out could not be read from secure
storage using defaults.
Service the PDM - Calibrate IP IBP analog out calibration values Perform analog out IP calibration.
Analog Out could not be read from secure
storage using defaults.
Service the PDM - Error Code MAC address could not be read Replace the main board.
0xPDM100C from hardware using default.
Service the PDM - Error Code Main CPU board 1.8V rail voltage Replace the main board.
0xPDM1100 out of spec.
Service the PDM - Error Code Main CPU board 12V rail voltage Replace the main board.
Service the PDM - Error Code Main CPU board -12V rail voltage Replace the main board.
Service the PDM - Error Code Main CPU board power bus voltage Replace the main board.
Service the PDM - Error Code ECG DAS board 1.26V rail voltage Replace the DAS assembly.

Troubleshooting

Service the PDM - Error Code ECG DAS board 5V rail voltage out Replace the DAS assembly.
0xPDM1108 of spec.
Service the PDM - Error Code ECG DAS board -7.5V rail voltage Replace the DAS assembly.
0xPDM110A out of spec.
Service the PDM - Error Code Main DAS board 1.26V rail voltage Replace the DAS assembly.
0xPDM110B out of spec.
0xPDM110C out of spec.
Service the PDM - Error Code Main DAS board 5V rail voltage out Replace the DAS assembly.
0xPDM110D of spec.
0xPDM110E out of spec.
Service the PDM - Error Code Main DAS board Nellcor 5V rail Replace the DAS assembly.
0xPDM110F voltage out of spec.
Service the PDM - Error Code Main DAS board Nellcor -3V rail Replace the DAS assembly.
0xPDM1110 voltage out of spec.
Service the PDM - Error Code Temperature out of spec. Replace the main board.
0xPDM1120
Required troubleshooting tools and equipment

The following equipment and tools are required for troubleshooting the PDM:
● Patient Data Module software CD with PDM Service Tool (shipped with Patient
Data Module)
● Solar 8000M/i patient monitor with PDM service adapter (2028845-002)
● PC with Microsoft Windows 7 operating system, a CDROM drive, and a network card
● Category 5 crossover cable (415480-001)
● ePort host interface cable (2017098-001)
If you are troubleshooting the PDM without the use of a monitor, the following kit is
required:
● PDM Service Tool Kit
￭ 2030924–003 (with power supply)
￭ 2030924–004 (without power supply)

Troubleshooting
Troubleshooting the absence of parameter data

Problem Possible causes Recommended actions
No parameter data Parameter cable is Check for loose cable connections. Tighten
from the module. disconnected. connections if loose.
Parameter interface is Check for damage to the parameter interface. If
damaged. damaged, contact GE technical support to service
the module.
Related parameter license is Check for licensing using the PDM Service Tool. If the
not activated. PDM license is not activated, install the license(s).
Host monitor is not Check that the host monitor is configured to display
configured to display the the parameter.
parameter.
Troubleshooting poor quality parameter data

Noisy waveforms, ● The ECG filter is not 1. Check to see if the ECG Filter setting is set to
missing markers or enabled. Enabled.
inaccurate patient
● The parameter cable or 2. Check for damage to the parameter cable. If
data.
parameter interface is damaged, replace the cables.
damaged.
3. Check for damage to the parameter interface. If
● The PDM and host damaged, contact GE technical support to service
monitor’s power the module.
frequency settings do
4. Check that the PDM power frequency setting
not match.
matches the host monitor’s power frequency
setting.
Troubleshooting invasive pressure measurement

Abnormally low Transducer wrongly Check mid-heart level and reposition transducer.
pressure. positioned.
No pressure. Defective transducer. Check or replace transducer.
Module not connected. Connect module.
Transducer adapter cable Connect the transducer adapter cable with the
not connected to the transducer to the module.
module.
Invasive pressure channel Configure the invasive pressure channel to the screen
not configured to the screen with adequate priority and check that it is active.
(with adequate priority).
Invasive pressure channel Zero the invasive pressure channel.
not zeroed.

Troubleshooting
Troubleshooting temperature measurement

No temperature Temperature channel not Configure the temperature channel to the screen
displayed. configured to the screen with adequate priority and check that it is active.
(with adequate priority).
Incompatible temperature Use correct probe (400 series).
probe.
The STP setting incorrect. Check the STP setting and configure it, if needed.
Faulty temperature probe. Replace temperature probe.
Temperature out of The measurement range is between 10 to 45°C (50
measurable range. to 113°F).
Troubleshooting non-invasive blood pressure

measurement
NIBP is not functioning. ● NIBP is not calibrated. 1. Check to see if calibration is required.
To check the NIBP Calibration Information, log onto
● Cuff pressure is not being
the PDM Service Tool. Select Device Information.
maintained.
2. To calibrate the NIBP measurement, perform the
NIBP calibration procedure.
3. Check to see if the NIBP cuff is maintaining cuff
pressure for at least one minute (listen for hissing
as the air escapes). If the cuff is leaking air, replace
the cuff.
4. If the NIBP measurement is still not functioning,
replace the NIBP assembly with manifold.
Unable to complete Maximum permitted gain Replace the main CPU.
NIBP calibration correction is exceeded.
because the Confirm When NIBP calibration
button is inactive. requires more than ±10%
change from the original
factory calibration, the NIBP
components on the main
CPU are not functioning
properly.
Troubleshooting the loss of communication

ePort to host interface cable Check for damage to the ePort to host interface
Communication LED is damaged. cable. If damaged, replace the cable.
indicator is not lit. ePort connector on monitor 1. Check for damage to the ePort connector on the
is damaged. monitor. If damaged, go to the monitor’s service
manual.

Troubleshooting
2. Connect a known good module to the monitor. If

the module is not powering, go to the monitor’s
service manual.
3. Connect the module to a known good monitor.
If the module is still not powering, replace the
module’s main board.
ePort connector on module Check for damage to the ePort connector on the
is damaged. module. If damaged, replace the module’s main
acquisition flex assembly.
Module is bad. Connect a known good module to the monitor.
Troubleshooting loss of power at the module

No power at the ePort host interface cable is Check for damage to the ePort to host interface
module. damaged. cable. If damaged, replace the cable.
ePort connector on monitor 1. Check for damage to the ePort on the monitor. If
is damaged. damaged, go to the monitor’s service manual.
2. Connect a known good module to the monitor. If
the module is not powering, go to the monitor’s
service manual.
3. Connect the module to a known good monitor.
If the module is still not powering, replace the
module’s main board.
ePort connector on the Check for damage to the ePort connector on the
module is damaged. module. If damaged, replace the module’s main
acquisition flex assembly.
Module battery is not Check the module battery.
charging.
Troubleshooting exterior damage

Top or bottom housing Top housing is damaged. Check for cracks or other damage to the top housing.
is damaged. If damaged, replace the top housing.
Bottom housing is damaged. Check for cracks or other damage to the bottom
housing. If damaged, contact GE technical support to
service the module.

Troubleshooting
Troubleshooting docking issues

The module will not The mounting rails on the Replace the mounting rails on the module.
dock to the docking module are damaged.
station.
The docking station is Check the docking station for damage. If damaged,
damaged. replace the docking station.
Troubleshooting temperature & voltage rails

service metrics
The TEMPERATURE & VOLTAGE RAILS service metric values are accessed via the PDM
Service Tool interface > Diagnostics > Service Metrics.
Service metric values that are highlighted red are not operating within the normal
operating specification.
Complete the following steps to troubleshoot:
1. If the Main DSP voltage and temperature value is highlighted red (out of
specification), replace the main board.
2. If the ARM and ECG voltage value is highlighted red (out of specification), contact
GE technical support to service the PDM.
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Troubleshooting Solar 8000M/I patient monitor

CONNECTING messages
Solar 8000M/I patient PDM is not admitted. 1. Perform an admit/discharge cycle with the PDM.
monitor randomly Solar 8000M/I patient ● If the message clears, the issue is resolved.
displays CONNECTING monitor may require service.
messages. ● If the message does not clear, go to the next
step.
2. Solar 8000M/I patient monitor has v5.3 software
or later.
● If the Solar 8000M/I patient monitor has
software v5.3 or later, contact GE technical
support to service the Solar 8000M/I patient
monitor.

Troubleshooting
● If the Solar 8000M/I patient monitor

has software v5.1 or v5.2, the random
CONNECTING message only affects the
following Solar 8000M/I patient monitor CPU
hardware with v5.1 or v5.2 software:
● Solar 8000M/i patient monitor with single video.
Product codes 3T, SBH, SBL, SCZ.
● CPU board p/n 2008705-002.
● Solar 8000M/I Dual Video. Product codes 3S,
SBJ, SBM. CPU board p/n 801586-002.
Contact GE technical support to update the Solar
8000M/I patient monitor CPU board.
Troubleshooting the battery

Battery is not charging. Battery tray is damaged. Check for damage to the battery tray. If damaged,
replace the battery tray.
Battery connector is 1. Check for damage to the battery connector inside
damaged. the battery compartment. If damaged, contact GE
technical support to service the module.
2. Check that the battery is charging by inserting
a known good battery in the module. If not
charging, contact GE technical support to service
the module.
Battery is bad. 1. Check that the battery is fully charged by pressing
the TEST button on the battery. If the LED is not at
100%, charge the battery.
2. Check for damage to the battery connector and
external surfaces. If damaged, replace the battery.
3. Check that the battery is charging with the GE
recommended battery charger. If not charging,
replace the battery.

Troubleshooting

Disassembly and reassembly
8
Disassembly guidelines
Field repair of the device is limited to replacing field replaceable units (FRUs).
WARNING Attempting a field repair on a PCB or a factory sealed
component or assembly could jeopardize the safe and
effective operation of the module, and void the warranty.
NOTE Only qualified service personnel should perform field

replacement procedures.
NOTE Perform the specified corrective maintenance check after any

corrective maintenance to the product.
ESD precautions
All external connectors of the device are designed with protection from ESD damage.
However, if the device requires service, exposed components and assemblies inside
are susceptible to ESD damage. This includes human hands, non-ESD protected work
stations or improperly grounded test equipment. The following guidelines may not
guarantee a 100% static-free workstation, but can greatly reduce the potential for
failure of any electronic assemblies being serviced:
● Discharge any static charge you may have built up before handling semiconductors
or assemblies containing semiconductors.
● Wear a grounded, antistatic wristband or heel strap at all times while handling or
repairing assemblies containing semiconductors.
● Use properly grounded test equipment.
● Use a static-free work surface while handling or working on assemblies containing
semiconductors.
● Do not remove semiconductors or assemblies containing semiconductors from
antistatic containers until absolutely necessary.
● Do not slide semiconductors or electrical/electronic assemblies across any surface.
● Do not touch semiconductor leads unless absolutely necessary.
● Store the semiconductors and electronic assemblies only in antistatic bags or
boxes.
● Handle all PCB assemblies by their edges.
● Do not flex or twist a circuit board.

Before PDM disassembly

● Turn off the PDM.
● If the PDM is in a mount, detach the PDM from the mount.
● Remove the PDM battery.
● Remove all external cables connected to the PDM.
Reassembly precautions
Pay attention to the following generic precautions when reassembling the patient
monitor:
● Note the positions of any wires, cables or connectors. Mark them if necessary to
ensure that they are reassembled correctly.
● Save and set aside all hardware for reassembly.
● GE recommends using the new fasteners (screws, washers, etc.) provided in the
FRU kits rather than reusing the old fasteners. Some fasteners are not intended
to be re-used.
When you fasten the screws:
● Visually ensure that the screws are properly attached.
● Do not use too much force, as this may damage the existing thread patterns.
Required tools
● T6 Torx driver
● T10 Torx driver
● Standard set of hand tools
● Safety glasses
● Antistatic wristband
Disassembly procedures
For reference, see the exploded view in Service parts chapter.



the module.

illuminates green.

Replacing the PDM front labels

1. Apply labels as shown.

Replacing the PDM bottom label

1. Apply the label in the label pocket as shown.
Replacing the PDM battery door and tray

1. Remove the one screw that holds the battery door to the housing and remove
the door and washer.
3. Use a flathead screwdriver to lift the catch tab on the tray as you pull it out of
the housing.

Replacing the PDM pull tab and mount rail

1. Remove the two screws on the latch stop and remove the latch stop.
2. Grasp the pull tab between thumb and index finger as shown and gently pull it
straight out about 1.27 cm/0.5 in. Lift the assembly out of the rail slot.
NOTE In the event that the pull tab assembly comes apart when
pulled from the rail slot, reassemble as shown below

3. Remove the two short screws (1) at the rear of the mount rail and the two long
screws (2) at the front of the mount rail.
4. Unseat the mount rail by twisting it slightly. Lift mount rail off the top housing.
NOTE When reassembling, make sure there are no gaps
between the mount rail and the housing when re-seating.
Replacing the PDM top housing

1. Remove the pull tab and mount rail.
2. Remove the four machine screws that hold the top and bottom housing together.
3. Turn the module right side up and lift off the top housing.
4. Install the top housing as follows:
a. Inspect the gasket (1) in the top housing to be sure it is securely placed in
the groove.

b. Make sure the flex connector to the front panel board is connected securely.
c. Starting at the rear of the module, position alignment pins of the top housing
into the bottom housing holes, then close the housing straight down.

d. Squeeze the top and bottom housings together to eliminate gaps. Install the
screw near the Power ON button first.
Replacing the PDM main board

1. Remove the top housing.
2. Disconnect the NIBP cable (1) from the connector without pulling on the wires.
3. Remove the six screws on the main board.

4. Remove the main board.

5. To install the main board:

a. Position the main board into the alignment pins (2).
b. Fold the flex material over the top of the board.

c. Hold the main board in place while installing screws.
6. If needed, re-install the PDM software, using the software included with the Main
board FRU kit.
7. Calibrate the analog outputs. Follow the procedure provided in this manual.
8. Re-enter the PDM licensing information, asset number, and serial number. Follow
the procedures provided in this manual.
Replacing the PDM NIBP hose and coupling

1. Remove the top housing and the main board.
2. Disconnect the front panel connector (1).
3. Disconnect the main board flex pump connector (2).

4. Hold flex out of the way and disconnect the NIBP hose from the coupling (3).
5. Remove the hose from the manifold (4).
NOTE When reassembling, slide the hose all the way onto the
manifold fitting so that the hose lays flat.
Replacing the PDM NIBP assembly with manifold hose

1. Remove the top housing, main board, NIBP hose and coupling.

2. Remove the four screws from the battery cover.
3. Grasp and slide the battery cover (1) out to the rear.
4. Remove the single screw from under the pump tube connection.
5. Lift off the manifold with pump.

6. Remove the interface gasket.
7. Before installing the NIBP assembly with manifold:

a. Make sure the pump and manifold are fully seated together.
b. Make sure the gasket is in place.
c. Position the manifold and pump in the bottom housing and carefully press to
seat connector.
d. Install the screw, then connect the hose. Slide hose all the way onto the
manifold fitting so that the hose lays flat.
e. Make sure the pump is resting between the positioning protrusions.
Replacing the PDM main flex circuit assembly

1. Using a T6 Torx driver, remove the three screws from the flex circuit assembly.

2. Remove the two screws (1) holding the battery connector to the bottom housing
and the two screws (2) holding the DAS rear cover to the bottom housing.
3. Insert a screwdriver under the DAS rear cover, pop up and remove the DAS rear
cover.
NOTE If the DAS rear cover is damaged, replace it with the new
cover provided in the FRU kit when reassembling the
module.

4. Remove the ePort connector attached to the flex circuit assembly from the
bottom housing.
5. Remove the flex circuit assembly from the module.

6. Before installing the replacement flex circuit assembly, ensure that the red gasket
(1) is in place on the DAS top cover (2) as shown. (Gasket may remain attached
to the removed flex circuit assembly.)
7. Replace the main flex circuit assembly in the reverse order of disassembly.

8. When replacing the DAS rear cover (1) , ensure that the red rectangular gasket is
in place as shown below. Note the two snap features (2) on the DAS rear cover
that secure the DAS rear cover to the bottom housing.
9. Press the DAS rear cover firmly into the bottom housing until the two snap
features snap into place as shown.
10. After replacing the flex assembly, reassemble the module in the reverse order.
Reassembling the module

1. Reassemble in reverse order. Make sure that:
a. All screws are tightened properly.
b. All cables are connected properly.
c. There are no loose objects inside the module.


Service parts
9
Ordering parts
To order parts, contact your local GE representative. Contact information is available
at www.gehealthcare.com. To make sure you get the correct service part, provide the
device type and the serial number information.

Service parts
PDM exploded views

Exploded view of mount rail and housing assembly, PDM

Service parts
Exploded view of NIBP assembly, PDM
Exploded view of main board assembly, PDM

Service parts
Exploded view of flex assembly, PDM
List of FRUs for PDM

Part number Description
2031069-002 FRU, Battery Door and Tray, PDM
● Battery tray with pull strap (#1)
● Battery door (#2)
● 1 mounting screw for battery door (#3)
2031069-003 FRU, Battery, PDM (#4)

Service parts

2031069-004 FRU, Mount Rail and Pull Tab, PDM
● Mount rail (#5)
● 2 short mounting screws for rear of mount rail/housing (#6)
● 2 long mounting screws for front of mount rail/housing (#7)
● Latch stop (#8)
● 2 mounting screws for latch stop (#9)
● Pull tab lock unit (#10)
2031069-033 FRU, Label Kit Nellcor, PDM
● Front Panel Label, Nellcor-OXI, English, PDM (#11)
● Front Panel Label, Nellcor-OXI, German, PDM (#11)
● Front Panel Label, Nellcor-OXI, French, PDM (#11)
● Front Panel Label, Nellcor-OXI, Swedish, PDM (#11)
● Front Panel Label, Nellcor-OXI, Spanish, PDM (#11)
● Front Panel Label, Nellcor-OXI, Italian, PDM (#11)
● Front Panel Label, Nellcor-OXI, Dutch, PDM (#11)
● Front Panel Label, Nellcor-OXI, Danish, PDM (#11)
● Front Panel Label, Nellcor-OXI, Norwegian, PDM (#11)
● Front Panel Label, Nellcor-OXI, Japanese, PDM (#11)
● Front Panel Label, Nellcor-OXI, Portuguese, PDM (#11)
● Front Panel Label, Nellcor-OXI, Russian, PDM (#11)
● Front Panel Label, Nellcor-OXI, Chinese, PDM (#11)
● Front Panel Label, Nellcor-OXI, Hungarian, PDM (#11)
● Front Panel Label, Nellcor-OXI, Polish, PDM (#11)
● Front Panel Label, Nellcor-OXI, Czech, PDM (#11)
● Front Panel Label, Nellcor-OXI, Greek, PDM (#11)
● Front Panel Label, Nellcor-OXI, Finnish, PDM (#11)
● Label, ADH Compliance, PDM (#12)
● Label, ADH, Compliance, Assembled in Mexico, PDM (#12)
2031069-034 FRU, Label Kit Masimo, PDM
● Front Panel Label, Masimo, English, PDM (#11)
● Front Panel Label, Masimo, German, PDM (#11)
● Front Panel Label, Masimo, French, PDM (#11)
● Front Panel Label, Masimo, Swedish, PDM (#11)
● Front Panel Label, Masimo, Spanish, PDM (#11)
● Front Panel Label, Masimo, Italian, PDM (#11)
● Front Panel Label, Masimo, Dutch, PDM (#11)
● Front Panel Label, Masimo, Danish, PDM (#11)

Service parts
● Front Panel Label, Masimo, Norwegian, PDM (#11)

● Front Panel Label, Masimo, Japanese, PDM (#11)
● Front Panel Label, Masimo, Portuguese, PDM (#11)
● Front Panel Label, Masimo, Russian, PDM (#11)
● Front Panel Label, Masimo, Chinese, PDM (#11)
● Front Panel Label, Masimo, Hungarian, PDM (#11)
● Front Panel Label, Masimo, Polish, PDM (#11)
● Front Panel Label, Masimo, Czech, PDM (#11)
● Front Panel Label, Masimo, Greek, PDM (#11)
● Front Panel Label, Masimo, Finnish, PDM (#11)
● Label, ADH Compliance, PDM (#12)
● Label, ADH, Compliance, Assembled in Mexico, PDM (#12)
2031069-007 FRU, NIBP Assembly With MFLD Hose, PDM
● NIBP assembly (#13)
● 1 mounting screw for NIBP assembly (#14)
● Manifold hose from pump to bezel (#15)
● 1 mounting screw for manifold hose (#16)
2031069-041 FRU, NIBP MFLD Hose With Coupling and Elbow Only, PDM
● Tubing for NIBP pump to bezel (#15)
● Coupling for NIBP at the front end of PDM, 3rd Edition (not shown)
● Fitting for pneumatic dual NIBP (not shown)
2031069-009 FRU, Top Housing, PDM
● Top housing (#17)
● 2 short mounting screws for rear of mount rail/housing (#6)
● 4 mounting screws for top and bottom housing (#19)
● 2 long mounting screws for front of mount rail/housing (#7)
2031069-010 FRU, Main Board (includes software CD), PDM
● Main board (#18)
● 6 mounting screws for the main board (#20)
2031069-015 FRU, Main Acquisition Flex Assembly UI Connector Update, PDM
● DAS rear cover (# 21)
● Main acquisition flex assembly (#22)
● Gasket for the ePort system flex cable (#23)
2017098-001 ePort to host interface cable, 1.52m (5ft.)
2017098-003 ePort to Host Interface Cable, 4.57m (15ft)

2017098-005 ePort to Host Interface Cable, 7.62m (25ft).

Service parts

2017098-007 ePort to Host Interface Cable, 13.72m (45ft).
2021968-001 PDM Mini Dock
2030340–002 PDM Bedside Dock
2030341–001 PDM Transport Dock

Service parts

Maintenance check form
10
Solar 8000M/I Patient Monitor Maintenance
Check Form
Solar 8000M/I Patient Monitor
Customer Monitor type S/N
Service record # Module type S/N
Customer Equipment ID Software version
Service Document # 2026265–075 Solar 8000M/I Patient Monitor
Planned maintenance Start date
Prior to testing, check that all equipment is calibrated via “Cal” labeling and record Cal Due Dates.
Measuring equipment used

Equipment/ tool Manufacturer Model/ Type/ Part Serial number/ ID Calibration due
No date
PASS = Test passed N.A.= Test is not applicable, a component or a FAIL = Test failed
feature is not part of the tested system.
Visual inspection
Observed
Visual inspection results Conclusion Comments
The front cover is intact.
All connectors are intact, clean and attached
The module casing and the latch are clean and intact.
The patient cables are clean and intact.

Electrical safety checks

Task Acceptance criteria Observed results Conclusion Comments
Power outlet is correctly wired per the required
electrical code standard for your country.
Ground continuity ≤ 0.1 ohms without
power supply cord
≤ 0.2 ohms with power

supply cord
Electrical leakage ≤ 0.1 ohms without
power supply cord
≤ 0.2 ohms with power
supply cord
Ground (earth) wire leakage current tests
Norm Pol, GND Open Current leakage ≤ 300 -
μA when powered from
100 to 120 V/50 to 60
Hz.
Current leakage is ≤
300 μA when powered
from a center-tapped
200 to 240 V/50 to 60
Hz single-phase circuit.
from a non-center
tapped 200 to 240 V/50
to 60 Hz single-phase
circuit.
RVS Pol, GND Open Current leakage ≤ 300
100 to 120 V/50 to 60
Hz.
200 to 240 V/50 to 60
from a non-center
circuit.
Enclosure leakage current tests


Norm Pol, GND Open Current leakage ≤ 300
100 to 120 V/50 to 60
Hz.
200 to 240 V/50 to 60
from a non-center
circuit.
100 to 120 V/50 to 60
Hz.
200 to 240 V/50 to 60
from a non-center
circuit.
GND Closed Current leakage ≤ 100
μA.
RVS Pol, GND Closed Current leakage ≤ 100
μA
Patient (source) leakage current tests — ECG
μA
μA
μA
μA
Patient (source) leakage current tests — SpO2
μA


μA
μA
μA
Patient (sink) leakage current tests — ECG
μA at 120 VAC using
the test body.
Current leakage ≤ 20
the test body.
μA at 120 to 240 VAC
using the cable.
μA at 120VAC using the
test body.
the test body.
using the cable.
Patient (sink) leakage current tests — SpO2
the test body.
the test body.
using the cable.
μA at 120VAC using the
test body.
the test body.
using the cable.

Functional check
Functional Check — ECG tests
ECG Test: Normal ECG II waveform is
Sinus Rhythm displayed on the screen
and is noise free.
Heart rate is 80 ±1 BPM
Audible QRS tone is
heard.
All 6 ECG leads are
available and are noise
free.
ECG Test: Pacemaker symbol
Pacemaker with asterisk is
Detection displayed in the ECG
parameter block.
Heart rate is 80 ±1 BPM
ECG Test: Leads Off RA FAIL is displayed on
Detection without the screen.
the RA leadwire
Lead II is replaced by
Lead III.
ECG Test: Leads Off Lead II is located in the
Detection with the top trace position.
RA leadwire
Check that the
waveform pulses are 1
mV in amplitude.
12SL ECG Analysis Check that the
waveform pulses are
equal to the input
voltage in amplitude.
All 12 leads are
available and are noise
free.
Functional Check — Impedance Respiration Tests

Impedance RESP waveform is
Respiration Tests: displayed on the screen
Respiration Rate: and is distortion free.
Lead II
RR value is 30 ±2
breaths per minute.
Impedance RESP waveform is
Respiration Tests: displayed on the screen
Respiration Rate: and is distortion free.
Lead I
RR value is 30 ±2
breaths per minute.

Functional Check — Invasive Pressure Tests

Invasive Pressure ART1 label and
Tests: ART1 label graticules are displayed
on the screen.
Invasive Pressure 240 ±4 mmHg
Tests: Static Pressure
(BP1)
Invasive Pressure BP1 waveform is
Tests: Pressure displayed on the screen
Waveforms (BP1) and is distortion free.
Blood pressure reading
is approximately
120/80 (93) mmHg.
(BP2)
is approximately
120/80 (93) mmHg.
(BP3)
is approximately
120/80 (93) mmHg.
(BP4)
is approximately
120/80 (93) mmHg.
Functional Check — Temperature Tests

Temperature Test: 37 ±0.4 °C
(T1)
Temperature Test: 37 ±0.4 °C
(T2)

Functional Check — Cardiac Output Tests

Cardiac Output IT Value displayed on
Tests: IT Value at the screen matches the
0.0 °C input.
Cardiac Output The C.O. reading is ±5%
Tests: C.O. Reading of the simulated value.
at 0.0 °C
Cardiac Output IT Value displayed on
Tests: IT Value at the screen matches the
24 .0 °C input.
Cardiac Output The C.O. reading is ±5%
Tests: C.O. Reading of the simulated value.
at 24.0 °C
Functional Check — SpO2 Tests

SpO2 Function A waveform with the
(Masimo) SpO2 label displays on
the screen.
The SpO2% reading is
78 to 84.
PRR reading is 60 to 62
BPM
SpO2 Function SpO2 reading is 75 ±2
(Nellcor OxiMax):
1st Test Pulse rate is 60 ±2

(Nellcor OxiMax):
2nd Test Pulse rate is 200 ±3

(Nellcor OxiMax):
3rd Test Pulse rate is 200 ±3

(Nellcor OxiMax):
4th Test Pulse rate is 200 ±3

(Nellcor OxiMax):
5th Test Pulse rate is 200 ±3
Functional Check — NIBP

NIBP Calibration The pressure readings
Check on the host monitor and
the manometer are the
same ±1 mmHg.

Functional Check — NIBP

NIBP Calibration Calibration completed Observed results Conclusion Comments
(Yes, No, NA)
Functional Check — Defib sync/Analog Output Test (Using an Oscilloscope or GE Analog Out/Defib Sync
Tester)
Defib sync/Analog The ECG signal
Output Tests resembles the
(Oscilloscope): ECG waveforms displayed in
the Service Manual.
Defib sync/Analog The Arterial BP
Output Tests signal resembles the
(Oscilloscope): waveforms displayed in
Arterial BP the Service Manual.
Defib sync/Analog The Marker Out
Output Tests signal resembles the
(Oscilloscope): waveforms displayed in
Marker Output the Service Manual.
Defib sync/Analog Negative spikes in the
Output Tests R-waves are displayed.
(Oscilloscope)
Defib sync/Analog The V lead waveform
Output Tests (GE resembles the primary
Analog Out/Defib ECG waveform.
Sync Tester)
The V lead waveform
resembles the BP
waveform.
The V lead waveform
has a marker pulse
corresponding to the
R wave of the primary
ECG waveform.
The negative spikes
in the R-waves are
displayed.

Compliance and specifications
11
Design, environmental, and physical
specifications
PDM specifications
Size (H x W x D 70 x 146 x 216 mm (2.8 x 5.7 x 8.5 in)
Weight 1.1 kg (2.4 lb) without optional battery
1.3 kg (2.9 lb) with optional battery
Operating temperature range 10 to 40°C (50 to 104°F)
Battery charging temperature 10 to 35°C (50 to 95°F)
range
Non-operating temperature -40 to 60°C (-40 to 140°F)
range
Operating humidity range 15 to 95% RH non-condensing
Non-operating humidity range 10 to 95% RH non-condensing
Degree of protection against IPX1
harmful ingress of water
Defib/Sync connector Analog output for ECG, invasive blood pressure, and
defibrillation synchronization output/input
PDM battery specifications

Battery model 2016989-003
Battery type Rechargeable Lithium-Ion battery
Size (H x W x D) 59 x 81 x 20 mm (2.3 x 3.2 x 0.8 in)
Weight 0.16 kg (0.36 lb)
Operating temperature range 10 to 40°C (50 to 104°F)
Charging temperature range 10 to 35°C (50 to 95°F)
Storage temperature range -20°C to 60°C (-4°F to 140°F)
Operating humidity range 10 to 95% RH non-condensing
Storage humidity range 5 to 95% RH non-condensing

Battery nominal voltage 10.8 V

Battery capacity 1.85 AH nominal
Battery run time (new fully Approximately 1.5 h
charged battery)
Battery charge time Approximately 2.5 h
Battery life 300 cycles to 60% capacity
Standards compliance
The system complies with the following standards.
● IEC 60601–1:2012–08
● IEC 60601-1-2:2007–03
● IEC 60601-1-6:2013–10
● IEC 60601-2-49:2011–02
● IEC 62304:2015–06
● IEC 62366:2014–01
Compliance with the standard IEC 60601-1:2012, 3.1 edition applies only to those
products that are currently being manufactured and shipped. It does not apply to
older devices or devices that have had their software upgraded.
Compliance to parameter and function specific standards is disclosed in the applicable
sections.
IEC 60601-1
● Type of protection against electrical shock: Class I.
● Degree of protection against electrical shock: applied parts are marked with a
symbol indicating degree of protection.
● Degree of safety of application in the presence of flammable anesthetic mixture
with air or with oxygen or nitrous oxide: Not suitable.
WARNING EXPLOSION. Do not use this equipment in the presence of
flammable anesthetics, vapors or liquids.
● Mode of operation: Continuous.

● Method(s) of sterilization or disinfection recommended by the manufacturer: see
the user’s manual.
Parameter specifications
ECG standards compliance
When used with a compatible module, the system complies with IEC
60601-2-25:2011–10, IEC 60601–2–27:2011–03 and AAMI EC57:2012.
Compatible module and specified accessories: applied parts are classified as TYPE CF
DEFIBRILLATION-PROOF per IEC 60601–2–27 Clause 201.6.2 and Clause 201.8.5.5.

When used to generate diagnostic ECG analysis reports, the system complies with
IEC 60601–2–25:2011–10.
NOTE Moderate and Maximum reduced bandwidths do not comply
with all requirements of the IEC 60601-2-27 standard.
ECG performance specifications

NOTE QT/QTc measurement is not available with combination monitoring.
ECG heart rate range 20 to 300 bpm

ECG heart rate accuracy ±1% or ±1 bpm, whichever is greater.
ECG heart rate resolution 1 bpm
ECG heart rate sensitivity > 0.5 mV peak
ECG heart rate response time Modules indicate a new heart rate for a step increase of 80 bpm to
120 bpm or a step decrease of 80 bpm to 40 bpm in < 10 s
Heart rate accuracy and response to Modules’ heart rate calculation operates with irregular rhythms of
irregular rhythm EC 60601-2-27 Clause 201.7.9.2.9.101 b) 4) as follows:
Ventricular bigeminy: 80 bpm
Slow alternating ventricular bigeminy: 60 bpm
Rapid alternating ventricular bigeminy: 120-128 bpm
Bidirectional systoles: 108-112 bpm
ECG heart rate averaging computation Average of 12 second median values

ECG heart rate display update interval Not less than once every 1 second
ECG QRS detection range ±0.5 to ±5 mV
ECG QRS detection width (Q to S) 40 to 120 ms
PVC rate range 0 to 300 PVCs per minute
PVC rate resolution 1 PVC per minute
ST numeric range -20.0 to +20.0 mm
ST numeric resolution 0.1 mm
ST numeric accuracy Per EC57 (ESC database):
● ST Mean Absolute Difference < 100 µV
● ST Mean Difference (Mean error) < 50 µV
● Correlation coefficient > 0.90
● ST tolerance ±0.4 mm or 20%, whichever is greater
ST averaging computation Average of 10 QRS complexes.
QRS numeric accuracy Per EC57 (AHA and MIT-BIH databases):
● QRS sensitivity >97.5%
● QRS positive predictivity: >97.5%

VEB numeric accuracy Per EC57 (AHA and MIT-BIH databases):

● VEB sensitivity >90%
● VEB positive predictivity: >90%
VF numeric accuracy Per EC57 (AHA and MIT-BIH databases):
● VF episode sensitivity >95%
● VF episode positive predictivity: >95%
QT numeric range 100 to 900 ms
QT numeric accuracy ±30 ms in the range 250 ms to 750 ms, unspecified outside this
range
QT numeric resolution 2 ms
QTc numeric range 100 to 900 ms
QTc numeric resolution 2 ms
ECG gain selections 0.5x = 5 mm/V
1x = 10 mm/V
2x = 20 mm/V
4x = 40 mm/V
ECG display bandwidth ● Diagnostic: 0.05 to 150 Hz
Diagnostic and Monitoring (at 60 Hz ● Monitoring:
powerline frequency) bandwidths
tested from 0.67 to 40 Hz as per IEC ￭ 50 Hz powerline frequency: 0.05 to 32 Hz
60601-2-27 Clause 201.12.1.101.8. ￭ 60 Hz powerline frequency: 0.05 to 40 Hz
With Monitoring (at 60 Hz powerline
frequency) bandwidth recorder tested for ● Moderate: 0.5 to 22 Hz
clause a) Frequency response method A ● Maximum: 5 to 25 Hz
and clause b) Impulse response
Moderate and maximum bandwidths
not tested from 0.67 to 40 Hz as per IEC
60601-2-27 Clause 201.12.1.101.8
ECG diagnostic (12SL) analysis signal 0.05 to 150 Hz
bandwidth
Low-pass filter setting 150 Hz tested as
per IEC 60601-2-25 Clause 201.12.4.107
ECG differential offset voltage (allowable ±0.4V
offset)
ECG input impedance ● Common mode: > 10 MΩ at 50/60 Hz
● Differential: > 2.5 MΩ from dc to 60 Hz
ECG system noise < 30 µV (referred to input)
ECG common mode rejection ratio 90 dB minimum at 50/60 Hz
Maximum tall T-wave rejection capability < 4.5 mV
(with a 1 mV QRS test signal)
ECG sweep speed options 6.25, 12.5, 25, and 50 mm/s
ECG leads available I, II, III, V1 to V6, aVR, aVL, and aVF
ECG leadsets supported 3-, 5-, 6-, or 10-leadwire ECG

Pacemaker pulse display capability ● Pulse width: 0.5 to 2 ms

● Voltage range:
￭ Sensitive mode: ±2 to ±700 mV
￭ Normal mode: Leads L and F minimum 2.3 mV, leads V/V1
and V5 minimum 3.5 mV
Pacemaker pulse rejection capability ● Voltage range: ±2 to ±700 mV
● Pulse width: 0.1 to 2 ms
Overshoot according to Method A IEC 60601-2-27 Clause
201.12.1.101.13 with amplitude max. 2 mV
Time constant:
● 4 to 8 ms
NOTE According to IEC 60601-2-27 Clause
201.12.1.101.13 an atrial pace pulse with
identical amplitude and duration precedes
ventricular pace pulse by 150 ms to 250
ms.
ECG leads disconnection (direct current ● Active patient electrode: < 30 nA

for leads-off) detection
● Reference electrode: < 270 nA
Defibrillation protection 5000 V, 360 J
ECG analog signal output (gain) 1 V/1 mV ±10%
ECG analog signal bandwidth 0.05 to 100 Hz
ECG analog output delay < 35 ms
Pacemaker marker 5 V ±10%, 2 ms ±5% pulse that is summed with the ECG analog
output
Sync signal Square pulse, low level 0 to 0.8 V, high level 9 to 10.5 V, duration
10 ms (±10%); output impedance < 10kΩ
Defibrillator sync delay < 35 ms
Impedance respiration performance specifications

Compatible modules and specified accessories: applied parts are classified as a
DEFIBRILLATION PROOF TYPE CF per IEC 60601–2–27 Clause 201.6.2 and Clause 201.8.5.5
Impedance respiration 1 to 200 breaths per minute

measurement range
Impedance respiration ● 0 to 120 breaths per minute: ±1 breath per minute
measurement accuracy
● 121 to 200 breaths per minute: ±3 breaths per
minute
Impedance respiration input ● Dynamic: 0.2 to 10 Ω
impedance range
● Static: 100 to 1500 Ω @ 52.7 kHz
Impedance respiration waveform 0.625, 6.25 mm/s, 12.5 mm/s, 25 mm/s and 50 mm/s
sweep speed options

Impedance respiration 140 µA AC RMS typical

normalized respiration sensing
current
Impedance respiration carrier 52.7 kHz typical
frequency
SpO2 standards compliance

When used with a compatible module, the system complies with ISO
80601–2–61:2011–04.
PDM and specified accessories: SpO2 applied parts are classified as TYPE CF
DEFIBRILLATION-PROOF per IEC 60601–1, Clause 6.
SpO2 displayed saturation values

Masimo SET and Nellcor OxiMax pulse oximetry are calibrated to display functional
saturation.
NOTE You can verify the functionality of pulse oximeter sensor and
monitor with a functional SpO2 tester but you cannot evaluate
their accuracy with such a device. For more information,
refer to the standard ISO 80601-2-61:2011–04 Annex FF
(Simulators, calibrators and functional testers for pulse
oximeter equipment).
This information may be useful to clinicians such as those performing photodynamic

therapy:
● Nellcor OxiMax pulse oximetry sensors contain LEDs that emit red light at a
wavelength of approximately 660 nm and infrared light at a wavelength of
approximately 900 nm. The total optical output power of the sensor LEDs is less
than 15 mW.
● Masimo SET pulse oximetry sensors contain LEDs that emit red light at a
wavelength of approximately 653 nm to 660 nm and infrared light at a wavelength
of approximately 880 nm to 905 nm. The total optical output power of the LEDs is
less than or equal to 15 mW.
SpO₂ summary of clinical studies used to establish accuracy

claims
Accuracy of Nellcor Oximax technology with Oximax sensors
Measurement modules using Nellcor Oximax Technology with Oximax sensors have
been validated for no motion accuracy in controlled hypoxia studies with healthy
non-smoking adult volunteers over the specified saturation SpO2 range(s). Pulse
oximeter SpO2 readings were compared to SaO2 values of drawn blood samples
measured by hemoximetry. Subjects used to validate SpO2 measurement accuracies
were healthy and recruited from the local population. Subjects comprised both adult
men and women and spanned a range of skin pigmentations. Because scatter and
bias of pulse oximeter SpO2 and blood SaO2 comparisons commonly increase as the
saturation decreases, and accuracy specifications are calculated from data spanning
the stated range, different accuracy values may result when describing partially
overlapping ranges. When sensors are used on neonatal subjects as 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 more detailed information, refer to the supplemental information analysis graphs
in the appendix (Bland and Altman. Agreement between methods of measurement
with multiple observations per individual. Journal of Biopharmaceutical Statistics
(2007) vol. 17 pp. 571–582).
Accuracy of SpO2 with the MAX-N sensor
Clinical functionality has been demonstrated on a 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, weight from 750 to 4100 grams, and 63 observations made spanning a
range of 85 to 99% SaO2.
Accuracy of SpO2 with Softcare SC-PR and SC-NEO sensors
Clinical functionality has been demonstrated on a population of hospitalized neonate
and infant patients. The observed SpO2 accuracy was 3.0% in a study of 57 patients
with ages of 24 to 40 weeks, weight from 710 to 5,000 grams, and 185 observations
made spanning a range of 63 to 100% SaO2.
Accuracy of Masimo SET technology with Masimo SET sensors
The Masimo SET Technology with Masimo sensors has been validated for no motion
accuracy in human blood studies on healthy adult male and female volunteers with
light to dark skin pigmentation in induced hypoxia studies in the range of 70-100%
SpO2 against a laboratory co-oximeter and ECG monitor. This variation equals ±1
standard deviation. Plus or minus one standard deviation encompasses 68% of the
population.
For detailed information, refer to the supplemental analysis graphs in sensor-specific
instructions for use provided by the sensor manufacturer.
SpO2 test methods used to establish accuracy claims during

motion
The Masimo SET Technology with Masimo sensors has been validated for motion
accuracy in human blood studies on healthy adult male and female volunteers with
light to dark skin pigmentation in induced hypoxia studies while performing rubbing
and tapping motions, at 2 to 4 Hz at an amplitude of 1 to 2 cm and non-repetitive
motion between 1 to 5 Hz at an amplitude of 2 to 3 cm in the range of 70% to 100%
SpO2 against a laboratory CO-oximeter and ECG monitor. This variation equals ±1
standard deviation, which encompasses 68% of the population.
NOTE Accuracy during motion has not been specified for Masimo
SET sensors TC-I, TF-I, DBI, Blue, and E-1.

SpO₂ test methods used to establish accuracy claims during

low perfusion
Low perfusion accuracy of Nellcor Oximax technology with Oximax sensors
Nellcor Oximax technology with Oximax sensors have been validated for SpO2 low
perfusion accuracy in bench top testing using Nellcor's PS II simulator with signal
strength setting of 0.03% modulation and oxygen saturation levels of 70 to 100% at
a pulse rate of 90 BPM. Nellcor Oximax Technology with Oximax sensors have been
validated for low perfusion pulse rate accuracy in bench top testing using Nellcor's PS
II simulator at a simulated low perfusion level of 0.10% modulation in the pulse rate
range of 40 to 250 beats per minutes (BPM) at a SpO2 of 95%.
Low perfusion accuracy of Masimo SET technology
The Masimo SET technology has been validated for low perfusion accuracy in bench
top testing against Biotek Index 2TM simulator and Masimo's simulator with signal
strengths of greater than 0.02% and transmission of greater than 5% for saturations
ranging from 70 to 100%. This variation equals ±1 standard deviation. Plus or minus
one standard deviation encompasses 68% of the population.
SpO₂ test methods used to establish pulse rate accuracy

Pulse rate accuracy of Nellcor Oximax technology with Oximax sensors
Nellcor Oximax technology with Oximax sensors has been validated for pulse rate
accuracy in bench top testing using Nellcor's PS II simulator over the specified range
at a SpO2 of 95%.
Pulse rate accuracy of Masimo SET technology with Masimo sensors
Masimo SET Technology with Masimo sensors has been validated for pulse rate
accuracy for the range of 25-240 bpm in bench top testing against a Biotek Index
2 simulator. The variation equals plus or minus one standard deviation, which
encompasses 68% of the population.
SpO2 performance specifications

NOTE Accuracy during motion has not been specified for Masimo SET
sensors TF-I, TC-I, E-1, DBI, and Blue.

Pulse oximetry saturation measurement 1 to 100%

value and display range
Pulse oximetry saturation measurement The specified accuracy for each module is the root-mean-square
value accuracy (RMS) difference between the measured values and the reference
values. Because pulse oximetry equipment measurements are
statistically distributed, only about two-thirds of the pulse oximetry
equipment measurements can be expected to fall within the ±1
Arms of the value measured by a CO-oximeter. Actual accuracy
depends on sensor. Please refer to the sensor instructions for use
for more detailed information.
(Nellcor):
● SpO2 (70 to 100%): ±2 Adult, ±2 Neonate
● SpO2 (60 to 80%): ±3 Adult, ±3 Neonate
● SpO2 (<60%): Unspecified
● Low perfusion:
￭ SpO2 (70 to 100%): ±2 Adult, ±2 Neonate
￭ SpO2 (< 70%): Unspecified
(Masimo):
● Without motion:
● With motion:
● Low perfusion:
Pulse oximetry saturation display 1 digit (% of SpO2)
resolution
Pulse oximetry declared pulse rate range (Masimo): 25 to 240 bpm
(Nellcor): 20 to 250 bpm
Pulse rate display range 20 to 300 bpm
Pulse oximetry peripheral pulse rate The specified accuracy for each module is the root-mean-square
accuracy (RMS) difference between the measured values and the reference
values. Actual accuracy depends on sensor. Please refer to the
sensor instructions for use for more detailed information.
(Masimo):
● Without motion: ±3 bpm Adult, ±3 bpm Neonate
● With motion: ±5 bpm Adult, ±5 bpm Neonate
● Low perfusion: ±3 bpm Adult, ±3 bpm Neonate
(Nellcor):
● ±3 bpm Adult, ±3 bpm Neonate
● Low perfusion: ±3 bpm Adult, ±3 bpm Neonate

Pulse oximetry peripheral pulse rate 1 bpm

display resolution
Pulse oximetry perfusion range (Masimo): 0.02 to 20%
(Nellcor): 0.03 to 20%
Pulse oximetry data update period < 30 s
Pulse oximetry saturation and pulse rate The (Masimo) provide averaging time options of 2, 4, 8, 10, 12, 14,
averaging time and 16 seconds. When using the default averaging time the overall
alarm generation delay of SpO2 is typically less than 28 seconds
from the actual SpO2 value in the patient. This delay is due to the
SpO2 averaging, signal processing and data transmission delays.
The delay consists of the alarm condition and alarm generation
delay, being typically <10 seconds and <18 seconds, respectively.
For pulse rate the alarm generation delay is typically less than 11
seconds, in which the alarm signal delay is less than a second. The
SpO2 and Pulse Rate data is updated every second.
The Nellcor OXIMAX algorithm used in the (Nellcor) measurement
module automatically extends the amount of data required for
measuring SpO2 and pulse rate depending on the measurement
conditions. There are various matrices within the saturation pulse
rate detection algorithm. Some of these are used to assess the
severity of conditions presented to the measuring of SpO2 and
pulse rate on a patient. These individual matrices or combinations
of these matrices are used to determine the quality of the received
SpO2 signal. The advanced signal processing in the algorithms
automatically extends the amount of data required for measuring
SpO2 and pulse rate depending on the measuring conditions.
During normal measurement conditions, the averaging time is
approximately three seconds. The overall alarm generation delay
of SpO2 is typically less than 28 seconds from the actual SpO2
value in the patient. This delay is due to the SpO2 averaging, signal
processing and data transmission delays. The delay consists of the
alarm condition and alarm generation delay, being typically <10
seconds and <18 seconds, respectively. For pulse rate the alarm
generation delay is typically less than 11 seconds, in which the
alarm signal delay is less than a second. The SpO2 and Pulse Rate
data is updated every second.
Pulse oximetry sweep speed options 6.25, 12.5, 25, and 50 mm/s
Signal strength indication Signal strength is indicated through the display of asterisks (No
asterisk, *, **, or ***). Three asterisks indicate good signal quality
and no asterisks indicate poor signal quality. All waveforms are
normalized to fit the allocated display area.
Pulse oximetry waveform scale options 1x, 2x, 4x, and 8x

Wavelength of SpO2 probe LEDs Information on the peak wavelengths and maximum output power
can be especially useful to clinicians performing photodynamic
therapy.
(Masimo):
● Infrared LED: 880 to 905 nm
● Red: 653 to 660 nm
(Nellcor):
● Infrared LED: 900 nm
● Red: 660 nm
Maximum energy of SpO2 probe LEDs Information on the peak wavelengths and maximum output power
can be especially useful to clinicians performing photodynamic
therapy.
< 15 mW
NIBP standards compliance

80601–2–30:2013–07.
The measurement has been validated with patient populations requiring clinical
investigations according to ISO 81060-2:2013 apart from pregnant and pre-eclamptic
women.
Compatible modules and specified accessories: applied parts are classified as TYPE BF
DEFIBRILLATION-PROOF per IEC 80601–2–30 Clause 201.6.
NIBP performance specifications

In the NICU software package, infant specifications are equal to neonatal specifications.
NIBP measurement technique Oscillometric

NIBP measurement supported modes Manual, Auto, and Stat
NIBP measurement range ● Adult: 25 to 260 mmHg (3.3 to 34.7 kPa)
● Child: 25 to 190 mmHg (3.3 to 25.3 kPa)
● Infant: 15 to 140 mmHg (2.0 to 18.7 kPa)
NIBP measurement range accuracy ● ±5 mmHg (0.7 kPa) average error, 8 mmHg (1.1 kPa) standard
deviation
Venous stasis characteristics (pressure Venous stasis pressure may be lower than the values above if the
and time) patient has low blood pressure. The venous stasis pressure adapts
to the measured mean pressure being approximately the same as
the mean pressure but always at least the following:
● Adult: 40 ±5 mmHg
● Child: 30 ±5 mmHg
● Infant: 20 ±5 mmHg
NIBP measurement default initial ● Adult: 135 mmHg (18.0 kPa)
inflation pressure
● Child: 125 mmHg (16.7 kPa)
● Infant: 100 mmHg (13.3 kPa)

Cuff pressure range 0 to 315 mmHg (0 to 42.0 kPa)

Supported cuff sizes ● Disposable: Large adult, adult, small adult, pediatric, child,
and neonatal
● Reusable: Adult thigh, adult forearm, large adult, adult, small
adult, small adult/child, child, and infant
Cuff maximum inflation pressure ● Adult: 290 ±6 mmHg (38.7 ±0.8 kPa)
● Child: 250 ±5 mmHg (33.3 ±0.7 kPa)
● Infant: 145 ±5 mmHg (19.3 ±0.7 kPa))
NIBP measurement available automatic 1 min, 2 min, 2.5 min, 3 min, 4 min, 5 min, 10 min, 15 min, 20 min,
cycle times 30 min, 1 h, 2 h, and 4 h
Invasive pressure standards compliance

60601-2-34:2011–05.
Compatible modules and specified accessories: applied parts are classified as TYPE CF
DEFIBRILLATION-PROOF per IEC 60601–2–34 Clause 201.6.
Invasive pressure performance specifications

Invasive pressure physiological range -25 to 320 mmHg (-3.3 to 42.7 kPa)
Invasive pressure measurement range -30 to 320 mmHg (–4 to 42.7 kPa
Invasive pressure measurement ±4% or ±4 mmHg (±0.5 kPa)
accuracy
Invasive pressure pulse rate range 30 to 300 bpm
Invasive pressure pulse rate accuracy ±2% or ±2 bpm, whichever is greater
Invasive pressure pulse rate display 1 bpm
resolution
Invasive pressure zero adjustment range ±150 mmHg (±20.0 kPa)
Invasive pressure zero adjustment ±1 mmHg (±0.1 kPa) or 2%, whichever is greater
accuracy
Invasive pressure frequency response User-selectable as DC to 12 Hz or 40 Hz (-3dB)
(waveform filter)
Invasive pressure waveform display 0-10 to 0-300 mmHg, with a step size of 10 mmHg (0.0-2.0, to
scale selections 0.0-40.0 kPa, with a step size of 2.0 kPa); or automatic scale based
on valid waveform values from last 4 seconds with a lower limit
of -100 mmHg (-14 kPa) and an upper limit of 350 mmHg (48 kPa)
and a step size of 10 mmHg (2.0 kPa)
Invasive pressure waveform display -30 to 300 mmHg (-4.0 to 40.0 kPa)
range
Invasive pressure sweep speed options 6.25, 12.5, 25, and 50 mm/s
Invasive pressure transducer sensitivity 5 µV/V/mmHg
Invasive pressure analog output signal 1 V/100 mmHg ±10%
(gain)

Invasive pressure analog output delay < 35 ms

Invasive pressure defibrillation recovery < 10 s
time
Temperature standards compliance

When used with a compatible module, the system complies with ISO
80601–2–56:2009–10.
PDM and specified accessories: applied parts are classified as TYPE CF
DEFIBRILLATION-PROOF per IEC 60601–1 Clause 6.
Temperature performance specifications

Temperature rated output range 10 to 45°C (50 to 113°F)
Temperature measurement range 0 to 45°C (32 to 113°F)
Temperature display range 0 to 45°C (32 to 113°F)
Temperature measurement accuracy With series 400 disposable probes:
● 0°C to 45°C (32°F to 113°F): ±0.3°C (±0.5°F)
With series 400 reusable probes:
● 0°C to 45°C (32°F to 113°F): ±0.2°C (±0.4°F)
Temperature measurement display ±0.1°C (±0.1°F)
resolution
Temperature measurement units °C or °F
Temperature probe types supported Series 400
Temperature test measurement cycle Every minute
C.O. standards compliance

PDM and specified accessories: applied parts are classified as TYPE CF
DEFIBRILLATION-PROOF per IEC 60601–1 Clause 6.
Cardiac output (C.O.) performance specifications

C.O. measurement technique Thermodilution
C.O. blood temperature range 17 to 42ºC (62.6 to 107.6ºF)
C.O. blood temperature accuracy ● 17 to 30ºC (62.6 to 86.0ºF): ± 0.5ºC (0.9ºF)
● 30 to 42ºC (86.0 to 107.6ºF) ± 0.2ºC (0.4ºF)
C.O. blood temperature display resolution 0.1ºC (0.1ºF)
C.O. injectate temperature range 0 to 30ºC (32.0 to 86.0ºF)
C.O. injectate temperature accuracy ± 0.3ºC (0.6ºF)
C.O. injectate temperature display 0.1ºC (0.1ºF)
resolution
C.O. measurement range 0.2 to 15 l/min

C.O. measurement accuracy ± 5%

C.O. display resolution 0.1 l/min

Electromagnetic compatibility (EMC)
12
IEC 60601-1-2
The system complies with IEC 60601-1-2:2007-03.
In accordance with IEC 60601-1-2, modules marked with the ESD warning symbol (IEC
60417-5134) require user training in ESD awareness and prevention as follows:
● The contents of the training are specified in the local ESD Control Program Plan,
issued in accordance with IEC 61340-5-1. The training should at least include an
introduction to ESD and its impacts on electrical devices and how to prevent it by
using appropriate personal protection equipment, proper work practices and tools.
According to parameter-specific IEC 60601–2–x series standard requirements for ESU
(electrosurgical unit) tests, the equipment is protected against malfunction caused
by electrosurgery.
Essential performance in EMC

ECG
ECG heart rate accuracy ± 1% or ±1 bpm, whichever is greater

ST numeric accuracy ST Mean Difference (Mean error) < 50 µV
NIBP
NIBP measurement range accuracy (over the Static: ± 2 mmHg (0.3 kPa)
display range)
SpO2
Pulse oximetry saturation measurement value SpO2 (70 to 100%): ± 2
accuracy
Pulse oximetry peripheral pulse rate accuracy ± 3 bpm
Temperature
Temperature measurement accuracy With series 400 probes: 25 to 45°C: ± 0.3°C
Invasive pressures
Invasive pressure measurement accuracy ± 4% or ± 4 mmHg (± 0.5 kPa)

C.O.
C.O. blood temperature accuracy ±0.5ºC
Electromagnetic compatibility safety

precautions
WARNING The use of accessories, transducers and cables other
than those specified may result in increased emissions or
decreased immunity performance of the equipment or
system.
WARNING Pins of connectors identified with the ESD warning symbol

should not be touched. Connections should not be made
to these connectors unless electrostatic discharge (ESD)
precautions are used.
WARNING EMC. Magnetic and electrical fields are capable of interfering

with the proper performance of the device. For this reason
make sure that all external devices operated in the vicinity
of the monitor comply with the relevant EMC requirements.
X-ray equipment or MRI devices are a possible source of
interference as they may emit higher levels of electromagnetic
radiation. Changes or modifications to this device/system
not expressly approved by GE may cause EMC issues with
this or other equipment. This device/system is designed and
tested to comply with applicable standards and regulations
regarding EMC and needs to be installed and put into service
according to the EMC information stated as follows: This
device/system is suitable for use in all establishments other
than domestic and those directly connected to the public
low-voltage power supply network that supplies buildings
used for domestic purposes. Mains power should be that of a
typical commercial or hospital environment.
WARNING The device/system should not be used adjacent to, or stacked

with, other equipment. Consult qualified personnel regarding
device/system configuration.
CAUTION Use of known RF sources, such as cell/portable phones,

or other radio frequency (RF) emitting equipment near the
system may cause unexpected or adverse operation of
this device/system. Consult qualified personnel regarding
device/system configuration.
CAUTION Changes or modifications to this device/system not expressly

approved by GE may cause EMC issues with this or other
equipment.
Electromagnetic emissions
The device is intended for use in the electromagnetic environment specified below.
The customer or the user of the device should assure that it is used in such an
environment.

Emissions test Compliance Electromagnetic environment - guidance

RF emissions Group 1 The Patient Data Module uses RF energy only for its internal
CISPR 11 function. Therefore, RF emissions are very low and are not likely
to cause any interference in nearby electronic equipment.
RF emissions Class A The equipment is suitable for use in all establishments other than
CISPR 11 domestic and those directly connected to the public low-voltage
power supply network that supplies buildings used for domestic
Harmonic emissions Class A purposes.
IEC 61000-3-2
Voltage Complies
fluctuations/flicker
emissions
IEC 61000-3-3
Electromagnetic immunity
This device is intended for use in the electromagnetic environment specified below.
It is the responsibility of the hospital to assure that the device is used in such an
environment.
Ut is the AC mains voltage prior to application of the test level.
Guidance and manufacturer’s declaration — electromagnetic immunity
Electromagnetic environment
Immunity test IEC 60601 test level Compliance level — guidance
Electrostatic Discharge ± 6 kV contact Floors should be wood, concrete
(ESD) ± 8 kV air or ceramic tile. If floors are
IEC 61000-4-2 covered with synthetic material,
the relative humidity should be
at least 30%.
Electrical Fast ± 2 kV for power supply lines Mains power quality should be
Transient/ Burst ± 1 kV for input/output lines that of a typical commercial or
IEC 61000-4-4 hospital environment.
Surge IEC 61000-4-5 ± 1 kV differential mode

± 2 kV common mode
Voltage dips, short <5% Ut (>95% dip in Ut) for 0.5 cycles Mains power quality should be
interruptions and 40% Ut (60% dip in Ut) for 5 cycles that of a typical commercial
voltage variations on or hospital environment. If the
power supply input 70% Ut (30% dip in Ut) for 25 cycles user of the equipment requires
lines <5% Ut (>95% dip in Ut) for 5 s continued operation during
IEC 61000-4-11 power mains interruptions,
it is recommended that the
equipment be powered from an
uninterruptible power supply or
a battery.
Power Frequency 3 A/m Power frequency magnetic
(50/60 Hz) Magnetic fields should be at levels
Field characteristic of a typical
IEC 61000-4-8 location in a typical commercial
or hospital environment.

Guidance and manufacturer’s declaration — electromagnetic immunity

Electromagnetic environment
Immunity test IEC 60601 test level Compliance level — guidance
Conducted RF 3 Vrms 150 KHz to 80 3 V rms Portable and mobile RF
IEC 61000-4-6 MHz communications equipment
should not be used closer to any
Radiated RF 3 V/m 80 MHz to 2.5 3 V/m part of the equipment, including
IEC 61000-4-3 GHz cables, than the recommended
separation distance calculated
from the equation applicable to
the frequency of the transmitter.
Recommended separation distance:

d = 1.2 √P
d = 1.2 √P 80 MHz to 800 MHz1
d = 2.3 √P 800 MHz to 2.5 GHz
where P is the maximum output power rating of the transmitter in watts (W) according
to the transmitter manufacturer, and d is the recommended separation distance
in meters (m).
Field strengths from fixed RF transmitters, as determined by an electromagnetic site
survey2, should be less than the compliance level in each frequency range.3
Interference may occur in the vicinity of equipment marked with the following symbol:
These guidelines may not apply in all situations. Electromagnetic propagation is

affected by reflection from structures, objects, and people.
Recommended separation distances

The following table provides the recommended separation distances (in meters)
between portable and mobile RF communications equipment and the device.
This device is intended for use in the electromagnetic environment on which
radiated RF disturbances are controlled. The customer or the user of the device
can help prevent electromagnetic interference by maintaining a minimum distance
between portable and mobile RF communications equipment (transmitters) and the
device as recommended below, according to the maximum output power of the
communications equipment.
1. At 80 MHz and 800 MHz, the higher frequency range applies.

2. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radio, AM and FM
radio broadcast, and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to
fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the
equipment is used exceeds the applicable RF compliance level above, the equipment should be observed to verify normal operation. If
abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the equipment.
3. Over the frequency range 150 KHz to 80 MHz, field strengths should be less than 3 V/m.

Rated Separation distance in meters (m) according to frequency of transmitter

maximum 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz
output power
of transmitter d = 1.2 d = 3.5 d = 4.4 d = 1.2 d = 3.5 d = 4.4 d = 2.3 d = 7.0 d = 8.8
in watts (W) √P √P √P √P √P √P √P √P √P
0.01 0.12 0.35 0.44 0.12 0.35 0.88 0.23 0.70 0.88
0.1 0.38 1.1 1.4 0.38 1.1 2.8 0.73 2.2 2.8
1 1.2 3.5 4.4 1.2 3.5 8.8 2.3 7.0 8.8
10 3.8 11 14 3.8 11 27.8 7.3 22 28
100 12 35 44 12 35 88 23 70 88
For transmitters rated at a maximum output power not listed above, the recommended
separation distance [d] in meters (m) can be estimated using the equation applicable
to the frequency of the transmitter, where P is the maximum output power rating of
the transmitter in watts (W) according to the transmitter manufacturer.
At 80 MHz and 800 MHz, the separation distance for the higher frequency range
applies.
These guidelines may not apply in all instances. Electromagnetic propagation is
affected by absorption and reflection from structures, objects and people.
Compliant cables and accessories

WARNING Use only approved accessories, including mounts, and
defibrillator-proof cables and invasive pressure transducers.
For a list of approved accessories, see the CARESCAPE
Monitors Supplemental Information Manual. Other cables,
transducers and accessories may cause a safety hazard,
damage the equipment or system, result in increased
emissions or decreased immunity of the equipment or system
or interfere with the measurement.


content
GE Medical Systems GE Medical Systems
Information Technologies, Inc. Information Technologies GmbH
8200 West Tower Avenue Munzingerstrasse 5
Milwaukee WI 53223 USA 79111 Freiburg
Tel: + 1 414 355 5000 Germany
1 800 558 5120 (US only) Tel: + 49 761 45 43 - 0
GE Medical Systems Information Technologies, Inc., a General Electric Company, doing business as GE
Healthcare.
www.gehealthcare.com

Patient Data Module: Service Manual

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Patient Data Module

Patient Data Module

2 Patient Data Module 2030046-006

2030046-006 Patient Data Module 3

4 Patient Data Module 2030046-006

2030046-006 Patient Data Module 5

6 Patient Data Module 2030046-006

2030046-006 Patient Data Module 7

8 Patient Data Module 2030046-006

Intended audience of this manual

NOTE Note statements provide application tips or other useful

2030046-006 Patient Data Module 9

Module naming conventions

Other naming conventions

Illustrations and names

10 Patient Data Module 2030046-006

Third party trademarks

2030046-006 Patient Data Module 11

12 Patient Data Module 2030046-006

WARNING Indicates a hazardous situation that, if not avoided, could

CAUTION Indicates a hazardous situation that, if not avoided, could

NOTICE Indicates a hazardous situation not related to personal injury

Consult operating instructions. / Operating instructions.

WARNING — Electric shock hazard. This equipment must be serviced by

2030046-006 Patient Data Module 13

Electrostatic sensitive device. Connections should not be made to this device

Non-ionizing electromagnetic radiation. Interference may occur in the vicinity

Type BF (IEC 60601-1) protection against electric shock. Isolated (floating)

Type BF (IEC 60601-1) defibrillator-proof protection against electric shock.

Type CF (IEC 60601-1) protection against electric shock. Isolated (floating)

Type CF (IEC 60601-1) defibrillator-proof protection against electric shock.

14 Patient Data Module 2030046-006

2030046-006 Patient Data Module 15

16 Patient Data Module 2030046-006

Calculated parameters are:

2030046-006 Patient Data Module 17

Back panel of the PDM:

ePort host interface connector

18 Patient Data Module 2030046-006

1. Communication icon and indicator.

2030046-006 Patient Data Module 19

Data Acquisition System board

Internal main components

20 Patient Data Module 2030046-006

ePort host interface cable

2030046-006 Patient Data Module 21

The following symbols appear on one or more of the devices.

Degree of ingress protection.

Manufacturer name and address.

Catalogue or orderable part number.

Device serial number.

Every device has a unique marking for identification. The UDI

Atmospheric pressure limitations.

This symbol indicates that the waste of electrical and electronic

Recycled materials or may be recycled.

22 Patient Data Module 2030046-006

The following symbols appear on one or more of the devices.

European authorized representative.

European Union Conformity Mark