Philips HEARTSTART XLT M3500B, HEARTSTART XLT M5500B User manual
HEARTSTART XLT
Service Manual
M3500B/
M5500B
Service Manual
M3500B HeartStart XLT/
M5500B Heartstart 4000
Defibrillator/Monitor
Notice
About This Edition
Edition 2
Printed in the USA
Publication number M3500-90900
The information in this manual applies
to the M3500B HeartStart XLT Release
Main 34 and earlier, and to the
Heartstart 4000 Release Main 34 and
earlier. This information is subject to
change without notice.
Philips Medical Systems 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.
Edition History
Edition 1.1, March 28, 2000
Edition 2, February 2003
Copyright
Copyright © 2003
Philips Electronics North America
Corporation
3000 Minuteman Road
Andover, MA 01810-1099 USA
(978) 687-1501
All rights are reserved. Reproduction in
whole or in part is prohibited without
the prior written consent of the copyright holder.
WARNING
Radio Frequency (RF) interference
from nearby transmitting devices may
seriously degrade performance of the
M3500B/M5500B defibrillator/monitor. Electromagnetic compatibility with
surrounding devices should be assessed
prior to using the defibrillator.
CAUTION
Use of supplies or accessories other
than those recommended by Philips
Medical Systems 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.
Medical Device Directive
The M3500B/M5500B Defibrillator/
Monitor complies with the requirements
of the Medical Device Directive 93/42/
EEC and carries the
accordingly.
Authorized EU-representative:
Philips Medizinsysteme Böblingen
GmbH
Hewlett Packard Str. 2
71034 Böbingen
Germany
Canada EMC:ICES-001
0123
mark
ii
Conventions
This manual uses the following text conventions:
NO TE Notes contain additional information on servicing this product.
CAUTION Caution statements describe conditions or actions that can result in damage to
the equipment or loss of data.
WARNING W arning statements describe conditions or actions that can result in personal injury
or loss of life.
Text represents messages that appear on the display
Softkey
represents softkey labels that appear on the display
above or below the button to which they correspond
iii
Contents
Introduction
Overview ............................................................................................................................... 1-1
Defibrillator/Monitor ...................................................................................................... 1-1
Batteries, Power Modules, Battery Charger Adapter ..................................................... 1-2
Installation ...................................................................................................................... 1-2
Upgrades ......................................................................................................................... 1-2
Preventive Maintenance .................................................................................................. 1-2
Repair Philosophy ...........................................................................................................1-3
Defibrillator/Monitor ................................................................................................ 1-3
Batteries, Power Modules, Battery Charger Adapter ............................................... 1-3
Performance Verification and Safety Tests
Overview ............................................................................................................................... 2-1
Mandatory Testing ................................................................................................................ 2-1
External Repairs/No Trouble Found ...............................................................................2-1
Printer .............................................................................................................................. 2-2
Internal Repairs ...............................................................................................................2-2
Test and Inspection Matrix ................................................................................................... 2-3
Test Equipment ..................................................................................................................... 2-8
Configuration and Diagnostic Modes ................................................................................. 2-10
Configuration Mode ...................................................................................................... 2-10
Diagnostic Mode ........................................................................................................... 2-11
Performance Verification .................................................................................................... 2-12
Visual Inspection .......................................................................................................... 2-12
Functional Checks ......................................................................................................... 2-13
ECG Functional Checks .......................................................................................... 2-13
Shock Advisory Functional Check ......................................................................... 2-14
Synchronized Cardioversion Functional Check ..................................................... 2-14
Functional Check ........................................................................................... 2-15
Sp0
2
Diagnostic Tests .................................................................................................................. 2-16
The System Log ............................................................................................................ 2-16
Extended Self Test ........................................................................................................ 2-17
User Interface Tests ...................................................................................................... 2-19
To check the Controls (keys): ................................................................................. 2-19
To check the display: .............................................................................................. 2-20
To check the audio output: ...................................................................................... 2-20
To check the printer: ............................................................................................... 2-21
ECG Tests ..................................................................................................................... 2-22
ECG Status messages .............................................................................................. 2-23
DC Offset ................................................................................................................ 2-23
ECG amplifier tests ................................................................................................. 2-23
PCI function ............................................................................................................ 2-24
v
Contents
Pacing Test ....................................................................................................................2-25
Defibrillator Test (AC Power At 200 J) ........................................................................ 2-27
Defibrillator Test (Battery Power At 200 J) ................................................................. 2-28
Defibrillator Disarm Test ..............................................................................................2-29
Safety Tests ...................................................................................................................2-30
Earth Leakage ......................................................................................................... 2-30
Patient Lead Leakage ..............................................................................................2-30
Battery Capacity Test ..........................................................................................................2-31
Troubleshooting
Overview ............................................................................................................................... 3-1
Repair Philosophy ...........................................................................................................3-1
Equipment Required ....................................................................................................... 3-1
Troubleshooting and Repair Methodology ........................................................................... 3-2
Interview the User ..................................................................................................... 3-2
Identify the Problem ................................................................................................. 3-2
Perform the Repair ....................................................................................................3-2
Test the Unit .............................................................................................................. 3-2
Initial Assessment ................................................................................................................. 3-3
Attempt Power Up .................................................................................................... 3-3
Evaluate the Response .............................................................................................. 3-3
Diagnosing External Failures ................................................................................................ 3-4
Capture the Configuration Data ................................................................................ 3-4
Print the System Log ................................................................................................. 3-4
Rule out external components and improper use ...................................................... 3-4
Diagnosing Internal Failures ................................................................................................. 3-5
Run Self Tests ........................................................................................................... 3-5
Use the Troubleshooting Tables ............................................................................... 3-5
Configuration and Diagnostic Modes ............................................................................. 3-5
Accessing Configuration Mode ...................................................................................... 3-5
Accessing Diagnostic Mode ........................................................................................... 3-6
Printing the System Log ........................................................................................... 3-6
Troubleshooting Tables ........................................................................................................ 3-8
Using the Tables ............................................................................................................. 3-8
Unit Unresponsive ................................................................................................................ 3-9
Error Codes ......................................................................................................................... 3-11
System Messages ................................................................................................................3-13
Momentary Messages ......................................................................................................... 3-16
Audio Tones .................................................................................................................. 3-17
Extended Self Test Failures .......................................................................................... 3-18
vi
Contents
Operational Problems ......................................................................................................... 3-19
ECG Monitoring ........................................................................................................... 3-19
SpO2 Monitoring ........................................................................................................... 3-21
Defibrillation and Cardioversion .................................................................................. 3-22
Pacing ............................................................................................................................ 3-24
Printer ............................................................................................................................ 3-25
Display .......................................................................................................................... 3-26
Audio ............................................................................................................................ 3-27
Keys .............................................................................................................................. 3-28
Battery and Power Modules .......................................................................................... 3-29
Data Card ......................................................................................................................3-31
Calling for Service - Philips HeartStart XLT ..................................................................... 3-32
United States of America .............................................................................................. 3-32
Latin America ............................................................................................................... 3-32
Canada .......................................................................................................................... 3-32
Other International Areas .............................................................................................. 3-33
Calling for Service - Laerdal Heartstart 4000 .....................................................................3-34
United States of America ......................................................................................... 3-34
International Customers ................................................................................................ 3-34
Removal and Replacement
Overview ............................................................................................................................... 4-1
Servicing Notes ..................................................................................................................... 4-1
Key Components ............................................................................................................. 4-1
Removal, Handling, and Replacement ........................................................................... 4-1
Flex Circuit Connections .......................................................................................... 4-1
Flex Circuit Handling ............................................................................................... 4-2
Internal Connections ................................................................................................. 4-2
Cable and Assembly Placement ................................................................................ 4-2
Instrument Reassembly ............................................................................................. 4-2
Tool Requirements ................................................................................................................ 4-3
User-replaceable Parts and Accessories ................................................................................4-4
Manual Door ................................................................................................................... 4-4
Removal .................................................................................................................... 4-4
Replacement ..............................................................................................................4-4
Carrying Case ................................................................................................................ 4-7
Removal .................................................................................................................... 4-7
Replacement ..............................................................................................................4-8
User Maintenance ................................................................................................................. 4-9
Cleaning the Printer Printhead ........................................................................................ 4-9
vii
Contents
External Assemblies ........................................................................................................... 4-10
Printer Assembly ........................................................................................................... 4-11
Removal .................................................................................................................. 4-11
Replacement ............................................................................................................4-12
Printer Sliding Door ...................................................................................................... 4-13
Removal .................................................................................................................. 4-13
Replacement ............................................................................................................4-13
Printer Platen .................................................................................................................4-14
Removal .................................................................................................................. 4-14
Replacement ............................................................................................................4-14
Battery Cover ................................................................................................................ 4-15
Removal .................................................................................................................. 4-15
Replacement ............................................................................................................4-16
Main Fuse ..................................................................................................................... 4-17
Removal .................................................................................................................. 4-17
Replacement ............................................................................................................4-17
Battery Eject Assembly ................................................................................................ 4-17
Removal .................................................................................................................. 4-17
Replacement ............................................................................................................4-18
Data Card Door ............................................................................................................. 4-18
Removal .................................................................................................................. 4-18
Replacement ............................................................................................................4-18
Labels .................................................................................................................................. 4-19
Label Descriptions ........................................................................................................ 4-19
Case Label Set ........................................................................................................ 4-19
Branding Label Set ................................................................................................. 4-21
Ambient Light Sensor Label ...................................................................................4-21
Speaker Label Set ................................................................................................... 4-22
Removing and Replacing Labels .................................................................................. 4-22
Removal .................................................................................................................. 4-22
Replacement ............................................................................................................4-22
Opening the Sealed Case .................................................................................................... 4-23
Discharging the Power Supply Capacitors ................................................................... 4-23
Primary Method ......................................................................................................4-23
Secondary Method: ................................................................................................. 4-23
Separating the Case ..................................................................................................... 4-25
Discharging the Defibrillator Capacitor ....................................................................... 4-27
Primary Method ......................................................................................................4-27
Secondary Method .................................................................................................. 4-28
Identifying Internal Subassemblies ..................................................................................... 4-29
viii
Contents
Top Case Assemblies .......................................................................................................... 4-30
Lithium Backup Battery ................................................................................................ 4-30
Removal .................................................................................................................. 4-30
Cleaning .................................................................................................................. 4-30
Replacement ............................................................................................................4-30
Disconnecting the Control PCA ................................................................................... 4-31
From the Rest of the Unit ....................................................................................... 4-31
From the Display .................................................................................................... 4-31
Reconnecting the Control PCA ..................................................................................... 4-31
To the Display ......................................................................................................... 4-31
To the Rest of the Unit ............................................................................................ 4-32
Control Stack ................................................................................................................ 4-33
Removal .................................................................................................................. 4-33
Replacement ............................................................................................................4-33
Control PCA ................................................................................................................. 4-34
Removal .................................................................................................................. 4-34
Replacement ............................................................................................................4-35
LCD Display Assembly ................................................................................................ 4-37
Removal .................................................................................................................. 4-37
Replacement ............................................................................................................4-37
SpO2 PCA ..................................................................................................................... 4-38
Removal .................................................................................................................. 4-38
Replacement ............................................................................................................4-39
ECG Connector .............................................................................................................4-40
Removal .................................................................................................................. 4-40
Replacement ............................................................................................................4-41
SpO2 Connector ............................................................................................................ 4-42
Removal .................................................................................................................. 4-42
Replacement ............................................................................................................4-43
Manual Keypad Assembly ............................................................................................ 4-44
Removal .................................................................................................................. 4-44
Replacement ..................................................................................................................4-47
Interface PCA ............................................................................................................... 4-50
Removal .................................................................................................................. 4-50
Replacement ............................................................................................................4-52
Speaker .......................................................................................................................... 4-55
Removal .................................................................................................................. 4-55
Replacement ............................................................................................................4-55
Top Case Assembly ............................................................................................................ 4-56
Description ..............................................................................................................4-56
Removal and replacement ....................................................................................... 4-56
ix
Contents
Bottom Case Assemblies .................................................................................................... 4-58
Battery PCA .................................................................................................................. 4-58
Removal .................................................................................................................. 4-58
Replacement ............................................................................................................4-59
Defibrillator Capacitor .................................................................................................. 4-60
Removal .................................................................................................................. 4-60
Replacement ............................................................................................................4-61
Power PCA ................................................................................................................... 4-62
Removal .................................................................................................................. 4-62
Replacement ............................................................................................................4-63
Power Connector ........................................................................................................... 4-64
Removal .................................................................................................................. 4-64
Replacement ............................................................................................................4-64
Patient Connector .......................................................................................................... 4-65
Removal .................................................................................................................. 4-65
Replacement ............................................................................................................4-65
Bottom Case Assembly ....................................................................................................... 4-66
The Language Support Tool ............................................................................................... 4-67
Using the Support Tool ................................................................................................. 4-67
Closing the case .................................................................................................................. 4-69
Disposing of the M3500B/M5500B ................................................................................... 4-70
Disposing of the SLA Battery ....................................................................................... 4-70
Replacement Parts
Overview ............................................................................................................................... 5-1
Ordering Replacement Parts ........................................................................................... 5-1
Ordering Supplies and Accessories ................................................................................ 5-1
Key Components ................................................................................................................... 5-1
Calling for Service - Philips HeartStart XLT ....................................................................... 5-2
United States of America ................................................................................................ 5-2
Latin America ................................................................................................................. 5-2
Canada ............................................................................................................................ 5-2
Other International Areas ................................................................................................ 5-3
Calling for Service - Laerdal Heartstart 4000 .......................................................................5-4
United States of America ........................................................................................... 5-4
International Customers .................................................................................................. 5-4
Special Tools ......................................................................................................................... 5-4
M3500B Unit Exchange Program ......................................................................................... 5-5
Logistics .................................................................................................................... 5-5
Replacement Parts Tables ..................................................................................................... 5-6
Electrical Assemblies ............................................................................................................ 5-7
Control PCA ................................................................................................................... 5-7
Other Replacement PCAs ............................................................................................... 5-8
Other Electrical Assemblies ............................................................................................ 5-8
Individual Electrical Parts ............................................................................................... 5-8
x
Contents
Mechanical Assemblies ........................................................................................................ 5-9
Manual Door ................................................................................................................... 5-9
Manual Keypad Assembly ............................................................................................ 5-10
Other Mechanical Assemblies ...................................................................................... 5-12
Connectors .................................................................................................................... 5-12
Individual Mechanical Parts ......................................................................................... 5-13
Labels .................................................................................................................................. 5-14
Case Label Sets ............................................................................................................. 5-14
Other Labels .................................................................................................................. 5-15
Supplies & Accessories ...................................................................................................... 5-16
Key Components .................................................................................................................5-20
Theory of Operation
Overview ............................................................................................................................... 6-1
PCA Descriptions ................................................................................................................. 6-2
Control PCA ................................................................................................................... 6-2
Interface PCA ................................................................................................................. 6-3
Power PCA ..................................................................................................................... 6-3
SpO2 PCA .......................................................................................................................6-3
Battery PCA ....................................................................................................................6-4
Battery ............................................................................................................................. 6-4
Printer .............................................................................................................................. 6-4
System Level Interconnections ............................................................................................. 6-5
System Functional Descriptions ........................................................................................... 6-6
Signal and Data Flow ...................................................................................................... 6-6
ECG Monitoring Functions ............................................................................................ 6-7
ECG - Pads ................................................................................................................ 6-7
ECG - 3/5-lead cable ................................................................................................. 6-7
Patient impedance functions ..................................................................................... 6-8
SpO2 Monitoring Functions ........................................................................................... 6-8
Defibrillation Functions .................................................................................................. 6-9
Charging .................................................................................................................... 6-9
Delivering a shock .................................................................................................... 6-9
Delivering synchronized cardioversion .................................................................. 6-10
Pacing Functions ...........................................................................................................6-11
Audio Functions ............................................................................................................ 6-12
Display Functions ......................................................................................................... 6-12
Contrast - manual control ....................................................................................... 6-12
Contrast - automatic control ................................................................................... 6-12
Backlight ................................................................................................................. 6-12
Indicator Functions ....................................................................................................... 6-13
Key Functions ............................................................................................................... 6-14
Main Keys ...............................................................................................................6-14
Other Keys ..............................................................................................................6-14
xi
Contents
Printing Functions ......................................................................................................... 6-15
Contrast ................................................................................................................... 6-15
Out of paper/door open ........................................................................................... 6-15
Battery/Power Functions ............................................................................................... 6-16
Contacts/Battery Type ............................................................................................ 6-16
Charging .................................................................................................................. 6-16
Lithium Backup Battery ................................................................................................ 6-18
Data Card ......................................................................................................................6-18
Specifications
Overview ............................................................................................................................... 7-1
Specifications ........................................................................................................................ 7-1
Defibrillator .................................................................................................................... 7-1
Manual Mode ............................................................................................................ 7-2
AED Mode ................................................................................................................ 7-3
ECG Monitoring ............................................................................................................. 7-3
Frequency Response: ................................................................................................ 7-4
Patient Isolation: ....................................................................................................... 7-4
Display ............................................................................................................................ 7-4
Thermal Array Printer ..................................................................................................... 7-4
Continuous Real Time Strip: .................................................................................... 7-4
Battery and Battery Power Modules ............................................................................... 7-5
Noninvasive Pacing ........................................................................................................ 7-6
SpO2/Pulse Oximetry ...................................................................................................... 7-6
Accuracy with: .......................................................................................................... 7-6
Event Storage ..................................................................................................................7-6
Internal Event Summary: .......................................................................................... 7-6
Data Card Event Summary: ...................................................................................... 7-6
General ............................................................................................................................ 7-7
Environmental ................................................................................................................. 7-7
Waveforms - 150J ................................................................................................................. 7-8
150J, 25 ohms .............................................................................................................. 7-8
150J, 50 ohms .............................................................................................................. 7-8
Waveforms -150J (continued) .............................................................................................. 7-9
150J, 75 ohms ............................................................................................................... 7-9
150J, 100 ohms ............................................................................................................ 7-9
Waveforms -150J (continued) ............................................................................................ 7-10
150J, 125 ohms (2ms/div) ........................................................................................ 7-10
150J, 125 ohms (5 ms/div) .......................................................................................... 7-10
xii
Contents
Waveforms - 200J ............................................................................................................7-11
Waveforms - 200J (continued) ........................................................................................... 7-12
Waveforms - 200J (continued) ...................................................................................... 7-13
Symbol Definitions .............................................................................................................7-14
Safety Considerations ......................................................................................................... 7-16
Electromagnetic Compatibility ........................................................................................... 7-18
Reducing Electromagnetic Interference ........................................................................ 7-18
Restrictions for Use ...................................................................................................... 7-18
Immunity Level ............................................................................................................. 7-19
xiii
1Introduction
This Service Manual provides the information needed to successfully service
the Philips M3500B HeartStart XLT and the Laerdal M5500B Heartstart 4000
Defibrillator/Monitors. The intended users of this manual are technical personnel who have been trained in the safe and proper servicing of the M3500B/
M5500B.
Overview
In this chapter, you’ll find general information that you should become familiar with before servicing the M3500B/M5500B. Detailed information regarding controls, operation, and capabilities of the instrument can be found in the
Instructions for Use that was shipped with the product. 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.
1
Defibrillator/Monitor
The M3500B/M5500B is a biphasic, semi-automatic external defibrillator.
This portable, lightweight device offers two modes of operation for defibrillation:
z Semi-Automatic External Defibrillation (AED) Mode
z Manual Mode
In AED Mode, the M3500B/M5500B analyzes the patient’s ECG and advises
the clinician whether or not to deliver a shock. In Manual Mode, the M3500B/
M5500B turns control of the defibrillation process over to the clinician. The
clinician analyzes the patient’s ECG, decides if defibrillation is advised, and
determines the energy setting for defibrillation. Manual Mode also allows the
clinician to perform synchronized cardioversion and offers optional noninvasive pacing (using a monophasic waveform).
Defibrillation is performed through multifunction defib electrode pads. In
addition, both AED and Manual Mode offer monitoring through pads, 3-lead
ECG monitoring electrodes, or optional 5-lead ECG monitoring electrodes.
Optional pulse oximetry (SpO
well.
) monitoring is available in both modes, as
2
1-1
Overview
The M3500B/M5500B automatically stores critical events, such as shocks
and alarm violations, in its internal memory. An Event Summary may be
printed at any time. The M3500B/M5500B also enables you to store data and
events on an M3510A/M5510A Data Card for downloading to the Event
Review Data Management System.
Batteries, Power Modules, Battery Charger Adapter
The M3500B/M5500B is powered by a rechargeable Sealed Lead Acid (SLA)
battery (M3516A/M5516A). Proper care of these batteries will ensure that
they have the energy required to operate the M3500B/M5500B and deliver the
appropriate therapy (See "Battery Maintenance" section in Instructions for
Use).
Batteries may be charged either in the defibrillator or in the Battery Charger
Adapter (M3506A/M5506A). In either case, power for charging can be provided by the AC Power Module (M3517A/M5517A), or by the DC Power
Module (M3518A/M5518A).
NO TE The defibrillator will take longer to charge when powered with either power
module without a battery installed. The recommended practice is to use a battery in conjunction with the power module to ensure optimal performance.
For information on either the power modules or the adapter, see the documentation supplied with the power module or adapter.
Installation
The M3500B/M5500B does not require installation. The Instructions for Use
describes the setup required before placing the device into service, as well as
configuration options.
Upgrades
Upgrades are available to add specific functionality to units in the field. As of
the publication of this manual, these upgrades are:
z M3514A Pacing Upgrade (adds pacing)
z M3515A SpO2 upgrade.
Consult your sales representative or dealer or distributor for the latest details.
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.
1-2 Introduction
Overview
Repair Philosophy
Defibrillator/Monitor
The repair philosophy of the M3500B/M5500B is subassembly replacement.
Examples of subassemblies are the printer, the Control Printed Circuit Assembly (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 outside of a fac-
tory authorized repair facility. Component level repair is extremely difficult
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 M3500B/M5500B.
Batteries, Power Modules, Battery Char ger Adapter
The repair philosophy for the SLA battery (M3516A/M5516A), AC Power
Module (M3517A/M5517A), DC Power Module (M3518A/M5518A), and
the Battery Charger Adapter (M3506A/M5506A) is unit replacement. These
accessories are not repaired in the field.
1
For information on ordering replacements, see "Supplies & Accessories" on
page 5-16.
M3500B/M5500B Service Manual 1-3
2 Performance Verification and Safety Tests
Overview
This chapter describes the tests and inspections required to verify performance of the M3500B/M5500B Defibrillator/Monitor.
The information is presented in the following sequence:
Test Matrix A list of the tests required to verify per-
formance of the M3500B/M5500B,
along with expected test results.
Test Equipment A list of commercially available test, cal-
ibration and simulation devices needed
to perform performance verification
tests.
Performance Verification Step-by-step instructions for performing
each of the Performance Verification
Tests.
Mandatory Testing
The Performance Verification Tests in this chapter are intended to verify
proper operation of the M3500B/M5500B following repair. The level of testing required corresponds to the type of repair performed, and is divided into 3
categories:
2
z External/No Trouble Found
z Printer
z Internal
External Repairs/No Trouble Found
External Repairs are those involving the repair or replacement of one or
more of the items below. No Trouble Found applies when no malfunction
can be found, or when the problem appears to be due to improper use. In
either situation, the key point is that the case has not been opened.
z ECG cable
z SpO
z Battery
cable or sensor
2
2-1
Mandatory Testing
z Labels
z AC or DC Power module
z Consumables (ECG monitoring electrodes, multifunction defibrilla-
tion pads, printer paper)
z Main fuse (on Battery PCA)
z Manual Door Assembly
z Data Card Door Assembly
z Battery Eject Assembly
The following testing is required after an External Repair or when the outcome of the service is No Trouble Found (when the case has not been
opened):
z Perform the Visual Inspection (page 2-12).
z Run the Extended Self Test (page 2-17).
z Print and Verify the System Log (page 2-16).
Printer
If the printer was replaced, and the case was not opened, the following tests
are required:
z Perform the Visual Inspection (page 2-12).
z Run the Extended Self Test (page 2-17).
z Run the Printer Test (page 2-21).
z Print and Verify the System Log (page 2-16).
Internal Repairs
If the case was opened (regardless of what the repair involved), all of the Performance Verification Tests must be performed, beginning with "Visual
Inspection" on page 2-12.
2-2 Performance Verification and Safety Tests
Test and Inspection Matrix
The matrix in Table 2-1 summarizes performance verification tests and
inspections for the M3500B/M5500B; including test name, test or inspection
to perform, expected test results, and data to record.
Table 2-1 Performance Verification and Safety Tests
Test and Inspection Matrix
Test Group Name
Visual Inspection
(VI)
Functional
Checks (F)
Test or Inspection to
Perform
Inspect unit, accessories,
cables, etc. as described on
page 2-12.
In normal Operating Mode,
perform the following functional checks:
• ECG (page 2-13). • Waveform clear on dis-
• Shock Advisory (page 2-
14).
• Synchronized Cardiover-
sion (page 2-14).
• SpO
(page 2-15). • 95% -100%
2
Expected Test Results
• If no unusual damage, no
corrosion, no missing
items,
then Visual Inspection
passes
• If all functions respond as
expected:
play; HR correct on display;
HR alarm works. Leads off,
pads off indicators as
expected.
• Shock Advised only when
appropriate
• Shock delivered with cor-
rect timing (<
60msec)
Data to Record
P (pass) or F (fail)
Example VI:p
Example F:p
2
then Functional test passes
Extended Self
Test (X)
In Diagnostic Mode, run the
Extended Self Test (page 2-
17). Includes Data Card Test
and time/date check.
If "Pass" reported on all
tests applicable to the device
configuration and options,
then Extended Self test
passes
Example X:p
M3500B/M5500B Service Manual 2-3
Test and Inspection Matrix
Table 2-1 Performance Verification and Safety Tests (Continued)
Test Group Name
User Interface
Tests (U)
ECG Tests (E) In Diagnostic Mode, run the
Test or Inspection to
Perform
• In Diagnostic Mode, run
the following tests
(page 2-19):
• Controls Test • All keys respond as
• Display Test • Display goes dark, then
• Audio Test • Alerts, alarms, and tones
• Printer Test • Print quality is adequate;
ECG Tests (page 2-22):
Expected Test Results
If all responses as expected: Example: U:p
expected
light. Black vertical bar
scrolls across the screen
from left to right.
are clearly heard
no stray marks or lines
• Print speed: 25 mm +
(1.25mm)
then User Interface test
passes
If all data within limits, all
checks pass:
5%
Data to Record
P (pass) or F (fail)
Example:E:p
• Status messages (lead,
pad, DSP)
PCI measurement If all PCI measurements are
• PCI - Test Load attached • 50 ± 30 Ω
• PCI - Pads open • >
Pacing Test (P) In Diagnostic Mode, run the
Pacing Test (page 2-25):
• 200 mA • 200 mA± 20 mA
• "Good" displayed for all
three status messages
within the following ranges:
2000 Ω
then ECG test passes
If measurement is within the
following limit:
then Pacing test passes
Example: P:p
2-4 Performance Verification and Safety Tests
Table 2-1 Performance Verification and Safety Tests (Continued)
Test and Inspection Matrix
Test Group Name
Defibrillator Test AC or DC P ower
Module (DM)
(Required only
when AC or DC
power module
used.)
Test or Inspection to
Perform
Using only the AC or DC
power module, enter Diagnostic Mode and run the
Defibrillator Test (at
200Joules) (page 2-27):
Displayed by
M3500B/M5500B:
• Available Energy after
Shock
• Msec to charge • <
• Delivered energy • Actual delivered energy
• Impedance • 42 to 57 Ω
• Defib errors • None (0)
Expected Test Results
If the measurements are as
follows:
• 0
15000 msec
200 +
7%
then the Defibrillator test
(Power Module) passes
Data to Record
P (pass) or F (fail)
Example: DM:p
2
Defibrillator Test Battery Power
(DB)
Defibrillator
Disarm Test (D)
Using only battery power,
enter Diagnostic Mode and
run the Defibrillator Test (at
200Joules) (page 2-28).
Displayed by
M3500B/M5500B
• Available Energy after
Shock
• Msec to charge • <
• Delivered energy • Actual delivered energy
• Impedance • 42 to 57 Ω
• Defib errors • None (0)
Enter Diagnostic Mode and
run the Defibrillator Disarm
Test (page 2-29)
If the measurements are as
follows:
• 0
3000 msec
200 +
7%
then the Defibrillator test
(Battery Power) passes
If all readings as expected
Available energy - failure >0
No errors reported
then the Defibrillator Disarm
test passes
Example: DB:p
Example: D:p
M3500B/M5500B Service Manual 2-5
Test and Inspection Matrix
Table 2-1 Performance Verification and Safety Tests (Continued)
Test Group Name
Safety Tests Indicate test results as
Earth Leakage
Current (S1)
(Required only
when AC Power
module is used.)
Patient Lead
Leakage (S3)
(Required only
when AC Power
module is used.)
Test or Inspection to
Perform
follows:
Earth Leakage Current NC
(Normal Condition)
Earth Leakage SF
(Single Fault - open neutral)
ECG Patient Cable If readings are as expected:
• Source
(Normal Condition) - aa
Expected Test Results
Note: All Safety tests include
both Normal and Reverse
Polarity conditions.
If NC maximum leakage
current:
300 uA (UL), <500 uA
<
and
If SF maximum leakage
current:
< 1000 uA
then S1 test passes
• <
10 uA
Data to Record
P (pass) or F (fail)
Example: S1:p/200/300
S3:p/aa/bb/cc/dd/ee/ff/ggg/
hhh/iii
Example: S3:p/9/49/49/10/
50/50/100/499/750
• Source (Single Fault
Condition - open earth,
open neutral) - bb
• With Mains on applied part
(Single Fault condition) - cc
SPO
2
• Source
(Normal Condition) - dd
• Source (Single Fault
Condition - open earth,
open neutral) - ee
With Mains on applied part
(Single Fault condition) - ff
• <
50 uA
• <
50 uA
then Safety Patient Lead
Leakage test passes
If readings are as expected:
• <
10 uA
• <
50 uA
• <
50 uA
then Safety Patient SPO2
Leakage test passes.
2-6 Performance Verification and Safety Tests
Table 2-1 Performance Verification and Safety Tests (Continued)
Test and Inspection Matrix
Test Group Name
Note: When recording test results, separate results within a test by slashes; separate tests by a semicolon (;); and
do not use empty spaces. For example:
VI:p;F:p;X:p;U:p;E:p;P:p;DM:p;DB:p;D:p;S1:p/200/300;S3:p/9/49/49/10/50/50/100/499/750
Test or Inspection to
Perform
Pads If readings are as expected:
• Source
(Normal Condition) - ggg
• Source (Single Fault
Condition) - hhh
• With Mains on applied part
(Single Fault condition) - iii
Expected Test Results
<
100 uA
<
500 uA
<
5000 uA
then Safety Pads Test
passes
Data to Record
P (pass) or F (fail)
2
M3500B/M5500B Service Manual 2-7
Test Equipment
Test Equipment
Table 2-2 lists the equipment needed to perform the Performance Verification
tests, and provides specifications for commercially available analyzers and
simulators. Test equipment is called out within each test procedure when
needed. In addition, a digital voltmeter is also useful.
A 50 ohm test load is available from Philips Medical Systems (M1781A).
Table 2-2 Equipment List
Equipment/Test Specifications
ECG Simulator
Calibrated Leads
• Amplitude accuracy ±2%
• Rate accuracy ±2%
Calibrated Paddles
• Amplitude accuracy ±2%
• Rate accuracy ±2%
Defibrillator Analyzer
Waveform compatibility Meets all specs below using biphasic
Load resistance: 50 Ω ±1% (non-inductive)
Maximum energy: ≥ 200 joules
Maximum voltage: ≥ 2500 V
Maximum current: ≥50 A
Measurement accuracy:
• ≥ 20 joules: ≤ ±2% of reading
• < 20 joules: ≤ ±0.4 joules
ECG simulator
ECG simulator
truncated exponential waveform.
Cardioversion measurement range: –150 to +150 ms
2-8 Performance Verification and Safety Tests
Table 2-2 Equipment List
Equipment/Test Specifications
Pacer tester
Load impedance: ≤400 Ω
Test Equipment
Current
• 10 mA–50 mA: <±2 mA
• 50 mA–200 mA: <±4%
Rate
• 30–180 ppm: <±0.5%
Waveform duration accuracy:
• 30–180 ppm: ±1ms
measurement accuracy
measurement accuracy
2
M3500B/M5500B Service Manual 2-9
Configuration and Diagnostic Modes
Configuration and Diagnostic Modes
The instructions below describe how to enter Configuration Mode and Diagnostic Mode.
Configuration Mode
These instructions describe briefly how to enter Configuration Mode. See the
Instructions for Use for details on configuration settings and what effect they
have.
CAUTION Inserting or removing the Data Card while the unit is on can corrupt the Data
Card and prevent the unit from powering on again. If this occurs, see Chapter
3, Troubleshooting.
1. Power off.
Make sure the unit’s power is off.
2. Insert the Data Card.
If you intend to save the configuration to a Data Card (or load the configuration from a Data Card), insert the Data Card now. To avoid possible
confusion, designate one Data Card as the "Configuration Card" and label
it clearly. Keep this card physically separate from cards used by the clinical staff for data storage.
3. Enter Configuration Mode.
Press softkeys 4 and 5 at the same time, and hold them down while turning the power on. See Figure 2-1 for softkey numbering.
4. Select and manage Configuration choices.
z To select a configuration, press the and softkeys to move up
or down the list until the desired Settings item is highlighted. Then
press the softkey to access those settings.
z To print out a strip with all the current configuration choices, select
Print All Settings and press .
z To store the configuration settings on a data card, select Save Settings
to Data Card and press . When prompted with Save Settings to
Data Card? press .
z To load configuration settings from a Data Card, select Load Settings
from Data Card and press . When prompted with Load Settings
from Data Card? press .
ENTER
ENTER
ENTER
SAVE
ENTER
LOAD
5. Exit Configuration Mode.
z To exit Configuration Mode, turn the unit off.
z Wait 2 seconds. Remove the Data Card by pressing the black eject
button and pulling the Data Card from the compartment.
2-10 Performance Verification and Safety Tests
Loading...