The information in this document applies to the
HeartStart MRx product version indicated below. This
information is subject to change without notice.
Philips shall not be liable for errors contained herein or
for incidental or consequential damages in connection
with the furnishing, performance, or use of this material.
Radio frequency (RF) interference from nearby
transmitting devices may degrade the performance of the
HeartStart MRx. Electromagnetic compatibility with
surrounding devices should be assessed prior to using the
monitor/defibrillator.
Koninklijke Philips Electronics N.V.
All rights are reserved. Permission is granted to copy and
distribute this document for your organization’s internal
educational use. Reproduction and/or distribution
outside your organization in whole or in part is
prohibited without the prior written consent of the
copyright holder.
SMART Biphasic is a registered trademark of Philips.
FilterLine is a registered trademark of Oridion Medical
Ltd.
Use of supplies or accessories other than those
recommended by Philips may compromise product
performance.
THIS PRODUCT IS NOT INTENDED FOR HOME
USE.
IN THE U.S., FEDERAL LAW RESTRICTS THIS
DEVICE TO SALE ON OR BY THE ORDER
OF A PHYSICIAN.
i
Conventions Used in This Manual
This Service Manual contains the following conventions:
WARNINGWarning statements describe conditions or actions that can result in personal injury or loss of life.
CAUTION Caution statements describe conditions or actions that can result in damage to the equipment or loss of
data.
NOTE Notes contain additional information on usage.
TIP Tips provide hands-on insight into servicing this product.
TEXTrepresents messages that appear on the screen
[Softkey]represents softkey labels that appear on the screen above or below the
button to which they correspond.
On-line viewing only
Hypertextrepresents hypertext links, which will display as blue; click on
Discharge the Power Supply Capacitors102
Separate the Case102
Discharge the Therapy Capacitor105
Disconnect the Case Halves106
Internal Assemblies - Front Case107
Overview of Front Case108
PCMCIA Hole Plug109
Speaker and Microphone Assembly111
Internal Memory Card113
SpO2 PCA115
Measurement Module Panel117
Therapy Switch119
Fan Assembly121
Processor PCA123
Clock Battery132
Printer Connector PCA133
Display Assembly135
Ready For Use Indicator138
Front Panel Buttons140
Front Case Assembly141
Internal Assemblies - Rear Case144
Overview of Rear Case145
Therapy Capacitor146
Power PCA148
NBP and CO2 Module Tray152
Therapy PCA154
Therapy Port158
NBP Module160
CO2 Module162
CO2 Compartment Door167
Battery Connector PCA169
Rear Case Assembly174
System Level Interconnections236
Signal and Data Flow237
ECG Signal Flow238
Functional Descriptions239
Processor PCA239
Therapy PCA240
Power PCA240
Battery Connector PCA240
Power/Batteries240
Display Assembly241
Indicators242
RFU Indicator242
Front Panel Buttons242
Therapy Knob242
Paddle Indicators and Controls242
Printer Assembly and Printer Connector PCA243
ECG Monitoring Functions243
Defibrillation244
Transcutaneous Pacing246
Audio246
Data Storage247
Clock Backup Battery247
NBP Module247
SpO2 PCA247
CO2 Module248
vii
8 Specifications and Safety249
Specifications249
General249
Defibrillator249
ECG and Arrhythmia Monitoring252
Display254
Battery254
Thermal Array Printer255
Noninvasive Pacing255
SpO2 Pulse Oximetry256
NBP256
EtCO2257
AwRR258
Calibration Gas for CO2 Measurement System259
12-Lead ECG259
Patient Data Storage259
Environmental (M3535A)259
Environmental (M3536A)261
Symbol Definitions263
Safety Considerations266
General266
Defibrillation268
Battery268
Electromagnetic Compatibility270
Reducing Electromagnetic Interference270
Restrictions for Use270
Emissions and Immunity270
Guidance and Manufacturer’s Declaration271
Waveforms278
1 Index283
This Service Manual provides the information needed to successfully service the M3535A/M3536A
HeartStart MRx monitor/defibrillator. This manual provides you with information on
troubleshooting, repairing, and performance verification and safety testing of the monitor/defibrillator.
There is also information on the theory of operation, maintenance procedures, and ordering parts and
supplies.
Who Should Use This Manual
The intended users of this manual are technical personnel who have been trained in the safe and proper
servicing of the HeartStart MRx. To assist in training, the Service Training video
(M3535-89300 NTSC, M3535-89310 PAL) is available.
1
1Introduction
Overview
In this chapter, you’ll find general information that you should know before servicing the HeartStart
MRx. Detailed information regarding controls, operation, and capabilities of the device can be found
in the Instructions for Use that was shipped with the product. The Instructions for Use also provides
information on setting up the device and regular maintenance procedures, such as performing
operational checks and battery maintenance. We recommend you review the Instructions for Use before
servicing this device. This Service Manual assumes you are familiar with the controls and with basic
operations.
This chapter is organized into the following sections:
To p icPa ge
Features and Capabilities2
Tour of the Device3
General Service Information8
Accessing Service Mode10
Other Resources16
1
1 IntroductionFeatures and Capabilities
Features and Capabilities
The HeartStart MRx is a lightweight, portable, monitor/defibrillator. It provides four modes of
operation, Monitor, Manual Defib, AED, and Pacer (optional).
In Monitor Mode you can monitor up to four ECG waveforms, acquired through a 3-, 5-, or 10-lead
ECG set or multifunction electrode pads. Optional monitoring of pulse oximetry (SpO
blood pressure (NBP), and carbon dioxide (EtCO
parameters are presented on the display and alarms are available to alert you to changes in the patient’s
condition.
Monitor Mode also provides an optional 12-Lead ECG function, enabling you to preview, acquire,
store, and print 12-lead ECG reports, with or without analysis/interpretation.
Manual Defib Mode offers simple, 3-step defibrillation. You analyze the patient’s ECG and, if
appropriate: 1) select an energy setting, 2) charge, and 3) deliver the shock. Defibrillation may be
performed using paddles or multifunction electrode pads. Manual Defib Mode also allows you to
perform synchronized cardioversion and internal defibrillation.
In AED Mode, the HeartStart MRx analyzes the patient’s ECG and determines whether a shock is
advised. Voice prompts guide you through the 3-step defibrillation process, providing easy-to-follow
instructions and patient information. Voice prompts are reinforced by messages that appear on the
display.
) are also available. Measurements from these
2
), noninvasive
2
Both Manual Defib and AED Mode incorporate the Philips’ low energy SMART Biphasic waveform
for defibrillation.
Optional Pacer Mode offers noninvasive transcutaneous pacing therapy. Pace pulses are delivered
through multifunction electrode pads, using a monophasic waveform.
The HeartStart MRx is powered by rechargeable lithium ion batteries. Available battery power is easily
determined by viewing the convenient battery power indicators located on the device display or by
checking the indicators on the battery itself. Additionally, an external AC or DC power supply may be
applied as a secondary power source and for continual battery charging.
The HeartStart MRx performs Automated Tests on a regular basis. The status of the device’s critical
functions are reported to the Ready For Use (RFU) indicator. Prominently displayed, the RFU
indicator communicates the status of your device, letting you know if it is operating correctly, needs
attention, or is unable to deliver therapy. In addition, performing the specified Operational Check
ensures that the HeartStart MRx is functioning properly.
The HeartStart MRx automatically stores critical event data in its internal memory, such as Event
Summaries and 12-Lead Reports. The HeartStart MRx also enables you to copy data and event
information on an optional external data card for downloading to Philips’ data management solution,
HeartStart Event Review Pro.
The HeartStart MRx is highly configurable to better meet the needs of diverse users. Be sure to
familiarize yourself with the device’s configuration before using the HeartStart MRx.
2
Tour of the Device1 Introduction
Tour of the Device
This section gives an overview of the outside of the device.
Figure 1 Front view
External Power Indicator
Synchronized Cardioversion
(Sync) button
Ready For Use (RFU)
Indicator
Mark Event
button
Lead Select
button
Display
Alarm Pause button
Event Summary
button
Soft keys (4 total)
c
n
y
S
120
b
b
i
i
100
f
f
e
e
70
D
D
l
l
a
a
50
u
u
n
n
a
a
30
M
M
20
15
1-10
n
O
P
acer
O
ff
M
onitor
Navigation buttons
A
dult
D
ose
150
170
200
S
elect
E
nergy
1
C
harge
O
n
AED
2
S
hock
3
Menu Select button
Therapy Knob
CHARGE button
SHOCK button
Printer
Printer door
Printer door
latch
Print button
Speaker
3
1 IntroductionTour of the Device
Right Side
Figure 2 Right side view
Data Card
Therapy port (behind connector)
Therapy connector
4
Tour of the Device1 Introduction
Left Side
Figure 3 Left side view
CO2 Inlet Port
CO2 Outlet Port
ECG Out (Sync)
Jack
2
CO
™
m
a
e
r
t
s
o
r
c
i
M
1
NBP Port
2
ECG Port
ECG
SpO2 Port
RJ11 Telephone
Jack
ECG
5
1 IntroductionTour of the Device
t
Rear
Figure 4 Rear view
Bed Rail Hook Moun
Battery/AC
Compartment B
Battery
Compartment A
LAN Connection
RS 232 Serial Port
AC Power Module
NOTE The LAN port is for factory use only.
Battery
DC Power Input
6
Tour of the Device1 Introduction
Top
Figure 5 Top view.
Top access panel
PCMCIA card slots
Internal memory card slot
7
1 IntroductionGeneral Service Information
General Service Information
Keep the following points in mind when servicing this product.
Installation
The HeartStart MRx does not require installation. The Instructions for Use describes the setup required
before placing the device into service, as well as configuration options. All setup activities are designed
to be performed by personnel trained in the proper operation of the product. To obtain a copy of the
Instructions for Use and other MRx documentation go to:
To display a menu, press the Menu Select button. Then use the up or down Navigation
buttons to scroll through the available choices until the desired selection is highlighted. To activate the
selection, press the Menu Select button. Press Exit to close the menu without activating a selection.
Passwords
In order to access different modes within the monitor/defibrillator, a password is required. The
passwords are listed below:
Upgrades
• Service Mode: 27689
• Configuration Mode: 387466
Upgrades are available to add specific functionality to the device after purchase. These upgrades are:
• M4765A Hardware Upgrade Option B01 - Version B hardware that supports 12-lead transmission
Consult your sales representative, dealer, or distributor for the latest details.
2
2
Preventive Maintenance
Preventive maintenance and periodic operational checks are intended to be performed by the user.
Both topics are covered in the Maintenance chapter of the Instructions for Use.
The Maintenance chapter of this manual provides procedures for the CO
procedures, which are intended to be performed by qualified service personnel.
8
and NBP calibration
2
General Service Information1 Introduction
Repair Philosophy
Monitor/Defibrillator
The repair philosophy of the HeartStart MRx is subassembly replacement. Examples of subassemblies
are the printer, the Processor Printed Circuit Assembly (PCA), Therapy PCA, and selected connectors
and other items. Repairs that involve replacing components on a PCA are not supported.
CAUTION Individual component replacement should not be attempted. Component level repair is inadvisable
due to the extensive use of surface mount technology and the high parts-density on the circuit boards.
Unauthorized component replacement can impair performance of the HeartStart MRx.
WARNINGRemove all power sources (AC, battery, DC) before opening the device. Failure to do so may allow the
device to charge without warning and could result in serious injury or death.
Batteries
The M3538A Lithium Ion battery is rechargeable. The battery periodically requires a calibration. At
the end of the battery’s useful life, it should be discarded and replaced. Refer to the Instructions for Use
for additional information.
For information on ordering replacements, see "Ordering Supplies and Accessories" on page 212.
WARNINGNever crush, penetrate or attempt to open lithium ion batteries. Never incinerate lithium ion batteries.
High case temperatures resulting from abuse of the battery could cause physical injury. The electrolyte
is highly flammable. Rupture of the battery pack may cause venting and flame.
CAUTION Due to their high energy density, lithium ion batteries can deliver significant power. Use care when
working with or testing lithium ion batteries. Do not short circuit the terminals.
9
1 IntroductionAccessing Service Mode
Accessing Service Mode
CAUTION Be sure that the monitor/defibrillator is not connected to a patient when performing any function in
Service Mode.
NOTE Make sure that you insert a battery charged to at least 20% into the device or connect external power
when you are performing functions in Service Mode.
To access Service Mode:
1. Turn the Therapy Knob to Monitor.
2. Press the Menu Select button to display the Main menu.
3. Select Other.
4. From the Other menu select Service.
The message “Leaving Normal Operating Mode. Patient Monitoring is Off. To return to Normal
Operating Mode, press the Exit Softkey.” appears.
5. Press the Menu Select button to acknowledge the message.
You are prompted to enter a password.
6. Enter the password (27689) by scrolling through the list until the desired number is highlighted.
7. Press the Menu Select button to activate each selection.
8. Select Done when you have entered all of the numbers.
10
Accessing Service Mode1 Introduction
The Service Mode Main menu is displayed, as shown in Figure 6.
Figure 6 Service Mode Main Menu
02 Mar 2003 10:52
Service
Exit
Service
.
MAIN
Service
Operational Check
Status Log
NBP
CO2
Controls
Printer
Device Info
Software Upgrade
Navigating in Service Mode
Service Mode uses the same navigation controls as normal operating mode:
• To select a menu item, use the Navigation buttons to highlight your choice, then select that choice
by pressing the Menu Select button.
• To exit Service Mode and return to clinical mode, press the [Exit Service] soft key.
• To return to the Service Mode Main menu from any service screen press the [Main Service]
soft key.
NOTE The device’s default configuration settings are restored when you return to clinical mode after exiting
Service Mode.
11
1 IntroductionAccessing Service Mode
Service Mode Functions
You can perform a variety of service related activities from Service Mode, as follows:
• Run an Operational Check - See “Operational Check” on page 39.
• View, print and clear the Status log - See “Status Log Errors” on page 55.
• Perform maintenance on the NBP module - See “Checking the NBP Module” on page 19.
• Perform maintenance on the CO
• Run the Controls test - See “Controls Test” on page 193.
• Run the Printer test - See “Printer Test” on page 194.
• View information about the device, such as model number, serial number, options enabled on the
device, and the device’s language - See “Device Info” on page 13. You also use the Device Info menu
to enter the serial number and to enable options on the device after a Processor PCA repair. See
“Entering the Serial Number and Enabling Options” on page 128 for more information.
NOTE You can print detailed information on board and module levels through the Print Device Info option,
available in normal operating mode. See “Printing the Device Information” on page 16.
• Install software and change the device’s language using the Software Support Tool - See “Software
Support Tool” on page 13.
module - See “Checking the CO2 Module” on page 23.
2
12
Accessing Service Mode1 Introduction
Device Info
To view information about the device:
1. From the Service Mode Main menu, select Device Info.
Figure 7 Device Info Screen
02 Mar 2003 10:52
Service
Model Number: M3536A
Serial Number: US00100320
Options: SpO2, CO2, NBP
Language: American English
.
DEVICE INFO
Main
Service
Software Support Tool
To install software onto the device or to change the device’s language:
1. Be sure an AC power module or battery charged to at least 20% is in place.
2. Insert the Software Support Tool into the data card slot.
3. From the Service Mode Main menu, select Software Upgrade.
4. Select the appropriate product version.
5. Press the [Upgrade] soft key.
The software is installed on the device. This process takes a few minutes. While the software is
being updated, progress messages are displayed and the [Main Service] soft key is disabled.
MENU
13
1 IntroductionAccessing Service Mode
NOTE
Be careful not to interrupt the software installation process by removing the power source or turning
the device off.
Figure 8 Software Upgrade Screen
02 Mar 2003 10:52
ServiceSOFTWARE UPGRADE
HeartStart MRx Version B.04.00 Upgrade: American English
.
Main
Service
6. When the software or language installation process is complete, turn the device off and on.
7. Run an Operational Check.
8. Review the Operational Check results to ensure all tests have passed.
See “Operational Check” on page 39.
9. Print the Device Info to ensure the product version or language is correct.
See “Printing the Device Information” on page 16.
Prev
Item
Next
ItemUpgrade
14
Accessing Service Mode1 Introduction
10. Affix the appropriate label found in the Software Support Tool kit to battery compartment B, as
show in Figure 9. Additionally, make sure that the customer has the Instructions for Use (found
on the User Documentation CD) that matches the product version.
Figure 9 Rear case labels
Primary label
Product Version
label
B2.04.00
NOTE The label that you apply to the device is in the format Xx.xx. This is functionally equivalent to the X.xx
Product Version that appears on the Device Info and Software Upgrade screens and the printed device
information report. For example, product version B2.04 is functionally equivalent to B.04.
15
1 IntroductionOther Resources
Printing the Device Information
You can print detailed information on product versions, and board and module levels from the Print
Device Info menu option. This option is available from the Other menu in clinical modes.
To print the device information:
1. Be sure a battery charged to at least 20% is in place, or that external power is connected.
2. Turn the Therapy Knob to Monitor.
3. Press the Menu Select button to access the Main menu.
4. From the Main menu, select Other.
5. From the Other menu, select Print Device Info.
Detailed information about the device is printed.
Other Resources
For additional information on the HeartStart MRx, refer to the following Learning Products:
• HeartStart MRx Instructions for Use (M3535-91900)
• HeartStart MRx Service Training Video (M3535-89300 NTSC, M3535-89310 PAL)
• HeartStart MRx Lithium Ion Battery Characteristics and Care Application Note (M3535-91930)
Other documentation can be found on the Philips website at:
This chapter describes how to perform routine maintenance on the HeartStart MRx
monitor/defibrillator.
Overview
Most routine maintenance is performed by the user. This includes:
• Performing operational checks
• Replacing paper
• Charging and maintaining the lithium ion battery
•Cleaning
2
2Maintenance
Refer to the Instructions for Use for detailed information on these maintenance procedures.
Service personnel are responsible for the following routine maintenance:
• Yearly calibration (or every 10,000 cycles) of the Noninvasive Blood Pressure (NBP) module
• Yearly calibration (or every 4000 hours) of the End-tidal Carbon Dioxide (EtCO
This chapter provides the following information:
To p icPa ge
Maintenance Tools and Equipment18
Checking the NBP Module19
Checking the CO
Module23
2
) module
2
17
2MaintenanceMaintenance Tools and Equipment
Maintenance Tools and Equipment
You will need the following equipment to perform the yearly calibration procedures:
• Password to access Service Mode (27689)
•NBP
– manometer
– expansion chamber (volume 250 ml +/- 10%) or an NBP cuff can be used
NOTE If you are using an NBP cuff, make sure it is wrapped around a solid object.
•CO
NOTE In addition to the items listed above, the calibration procedures require tubing and connectors typically
found in a biomedical engineering shop.
2
– calibration gases and regulator
cal 1 gas 15210-64010 (5% CO
cal 2 gas 15210-64020 (10% CO
cal gas flow regulator M2267A
– electronic flowmeter, M1026-60144
– Gas calibration equipment
cal tube 13907A
FilterLine set, M1920A
– local barometric pressure rating or reading received from a reliable local source (airport, regional
weather station, or hospital weather station) which is located at the same altitude as the hospital
or EMS service.
– calculator
)
2
)
2
18
Checking the NBP Module2 Maintenance
Checking the NBP Module
NBP
These instructions describe how to test the NBP measurement function. A complete test consists of the
following activities, which are described in detail in this chapter.
NBP CheckPage
Setup
Setup
Check the status displays
Test the accuracy
Test for leaks
Tes t t he l i ne a r it y
Calibrate the NBP Measurement
Run an Operational Check
Each of the procedures assumes the monitor/defibrillator, the manometer, and the expansion chamber
are still set up as they were at the end of the previous test.
If all results are as described, the device passes that portion of the test. Return to the Service Mode
Main menu by pressing the [Main Service] soft key.
If there is any failure, begin troubleshooting and repairing the device as needed. See
“Troubleshooting” on page 33.
1Access the Service Mode Main menu as described in “Accessing Service Mode” on page 10.
2From the Service Mode Main menu, select NBP.
The NBP Service screen is displayed.
19
20
21
21
22
22
22
19
2MaintenanceChecking the NBP Module
NOTE
You will hear a high-pitch tone when you access the NBP Service screen - this is normal operation.
Figure 10 NBP Service Screen
02 May 2003 10:52
Service
Cycle Counter: 50,010
Last Calibration: 2 May 2004
Pressure In Cuff: 23 mmHg
.
NBP
Replacement recommended
Calibration recommended
Main
Service
Check the status displays
1. Check the cycle counter.
Check the number of measurement cycles shown on the screen. If the NBP module has executed
more then 50,000 cycles, replacement is recommended. See “NBP Module” on page 160 for
instructions on replacing the NBP module.
Following replacement, run the required Performance Verification and Safety Tests (see “Required
Testing Levels” on page 180).
2. Check the calibration status.
If the screen indicates that calibration is recommended, perform all of the actions described in this
chapter, beginning with "Test the accuracy".
The calibration status is automatically reset at the successful completion of a calibration.
20
Calibrate
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