Philips HEARTSTART XLT M3500B, HEARTSTART XLT M5500B User manual

H E A R TS TA R T X LT

S e r v i c e M a n u a l

M 3 5 0 0 B /

M 5 5 0 0 B

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 [phone]

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 0123 mark accordingly.

Authorized EU-representative:

Philips Medizinsysteme Böblingen GmbH

Hewlett Packard Str. 2 71034 Böbingen Germany

Canada EMC:ICES-001

ii

Conventions

NOTE

CAUTION

WARNING

This manual uses the following text conventions:

Notes contain additional information on servicing this product.

Caution statements describe conditions or actions that can result in damage to the equipment or loss of data.

Warning statements describe conditions or actions that can result in personal injury or loss of life.

Text		represents messages that appear on the display
		represents softkey labels that appear on the display
	Softkey
		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
Sp02 Functional Check ...........................................................................................	2-15
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

1 Introduction

1

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.

Defibrillator/Monitor

The M3500B/M5500B is a biphasic, semi-automatic external defibrillator. This portable, lightweight device offers two modes of operation for defibrillation:

zSemi-Automatic External Defibrillation (AED) Mode

zManual 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 (SpO2) monitoring is available in both modes, as

well.

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 pro-
		vided by the AC Power Module (M3517A/M5517A), or by the DC Power
		Module (M3518A/M5518A).
NOTE		The	defibrillator will take longer to charge when powered with either power
		module without a battery installed. The recommended practice is to use a bat-
		tery in conjunction with the power module to ensure optimal performance.
		For information on either the power modules or the adapter, see the documen-
		tation 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		1
		The repair philosophy of the M3500B/M5500B is subassembly replacement.
		Examples of subassemblies are the printer, the Control Printed Circuit Assem-
		bly (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-den-
		sity on the circuit boards. Unauthorized component replacement can impair
		performance of the M3500B/M5500B.

Batteries, Power Modules, Battery Charger 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.

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		2
		This chapter describes the tests and inspections required to verify perfor-
		mance 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:

zExternal/No Trouble Found

zPrinter

zInternal

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.

zECG cable

zSpO2 cable or sensor

zBattery

2-1

Mandatory Testing

zLabels

zAC or DC Power module

zConsumables (ECG monitoring electrodes, multifunction defibrillation pads, printer paper)

zMain fuse (on Battery PCA)

zManual Door Assembly

zData Card Door Assembly

zBattery 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):

zPerform the Visual Inspection (page 2-12).

zRun the Extended Self Test (page 2-17).

zPrint 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:

zPerform the Visual Inspection (page 2-12).

zRun the Extended Self Test (page 2-17).

zRun the Printer Test (page 2-21).

zPrint 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

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
						2
Test Group Name	Test or Inspection to		Expected Test Results	Data to Record
	Perform			P (pass) or F (fail)
Visual Inspection	Inspect unit, accessories,		• If no unusual damage, no	Example VI:p
(VI)	cables, etc. as described on		corrosion, no missing
	page 2-12.		items,
			then Visual Inspection
			passes
Functional	In normal Operating Mode,		• If all functions respond as	Example F:p
Checks (F)	perform the following func-		expected:
	tional checks:
	• ECG (page 2-13).		• Waveform clear on dis-
			play; HR correct on display;
			HR alarm works. Leads off,
			pads off indicators as
			expected.
	• Shock Advisory (page 2-		• Shock Advised only when
	14).		appropriate
	• Synchronized Cardiover-		• Shock delivered with cor-
	sion (page 2-14).		rect timing (< 60msec)
	• SpO2 (page 2-15).		• 95% -100%
			then Functional test passes
Extended Self	In Diagnostic Mode, run the		If "Pass" reported on all	Example X:p
Test (X)	Extended Self Test (page 2-		tests applicable to the device
	17). Includes Data Card Test		configuration and options,
	and time/date check.		then Extended Self test
			passes

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2-3

Test and Inspection Matrix

Table 2-1 Performance Verification and Safety Tests (Continued)

	Test Group Name	Test or Inspection to	Expected Test Results	Data to Record
		Perform		P (pass) or F (fail)
	User Interface	• In Diagnostic Mode, run	If all responses as expected:	Example: U:p
	Tests (U)	the following tests
		(page 2-19):
		• Controls Test	• All keys respond as
			expected
		• Display Test	• Display goes dark, then
			light. Black vertical bar
			scrolls across the screen
			from left to right.
		• Audio Test	• Alerts, alarms, and tones
			are clearly heard
		• Printer Test	• Print quality is adequate;
			no stray marks or lines
			• Print speed: 25 mm + 5%
			(1.25mm)
			then User Interface test
			passes
	ECG Tests (E)	In Diagnostic Mode, run the	If all data within limits, all	Example:E:p
		ECG Tests (page 2-22):	checks pass:
		• Status messages (lead,	• "Good" displayed for all
		pad, DSP)	three status messages
		PCI measurement	If all PCI measurements are
			within the following ranges:
		• PCI - Test Load attached	• 50 ± 30 Ω
		• PCI - Pads open	• > 2000 Ω
			then ECG test passes
	Pacing Test (P)	In Diagnostic Mode, run the	If measurement is within the	Example: P:p
		Pacing Test (page 2-25):	following limit:
		• 200 mA	• 200 mA± 20 mA
			then Pacing test passes

2-4	Performance Verification and Safety Tests

			Test and Inspection Matrix
Table 2-1 Performance Verification and Safety Tests (Continued)
Test Group Name	Test or Inspection to	Expected Test Results	Data to Record
	Perform		P (pass) or F (fail)
Defibrillator Test -	Using only the AC or DC	If the measurements are as	Example: DM:p
AC or DC Power	power module, enter Diag-	follows:
Module (DM)	nostic Mode and run the
(Required only	Defibrillator Test (at
when AC or DC	200Joules) (page 2-27):
power module					2
used.)
	Displayed by
	M3500B/M5500B:
	• Available Energy after	• 0
	Shock
	• Msec to charge	• < 15000 msec
	• Delivered energy	• Actual delivered energy
		200 +7%
	• Impedance	• 42 to 57 Ω
	• Defib errors	• None (0)
		then the Defibrillator test
		(Power Module) passes
Defibrillator Test -	Using only battery power,	If the measurements are as	Example: DB:p
Battery Power	enter Diagnostic Mode and	follows:
(DB)	run the Defibrillator Test (at
	200Joules) (page 2-28).
	Displayed by
	M3500B/M5500B
	• Available Energy after	• 0
	Shock
	• Msec to charge	• < 3000 msec
	• Delivered energy	• Actual delivered energy
		200 +7%
	• Impedance	• 42 to 57 Ω
	• Defib errors	• None (0)
		then the Defibrillator test
		(Battery Power) passes
Defibrillator	Enter Diagnostic Mode and	If all readings as expected	Example: D:p
Disarm Test (D)	run the Defibrillator Disarm	Available energy - failure >0
	Test (page 2-29)	No errors reported
		then the Defibrillator Disarm
		test passes

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2-5

Test and Inspection Matrix

Table 2-1 Performance Verification and Safety Tests (Continued)

	Test Group Name	Test or Inspection to	Expected Test Results	Data to Record
		Perform		P (pass) or F (fail)
	Safety Tests	Indicate test results as	Note: All Safety tests include
		follows:	both Normal and Reverse
			Polarity conditions.
	Earth Leakage	Earth Leakage Current NC	If NC maximum leakage	Example: S1:p/200/300
	Current (S1)	(Normal Condition)	current:
	(Required only		< 300 uA (UL), <500 uA
	when AC Power		and
	module is used.)
		Earth Leakage SF	If SF maximum leakage
		(Single Fault - open neutral)	current:
			< 1000 uA
			then S1 test passes
	Patient Lead			S3:p/aa/bb/cc/dd/ee/ff/ggg/
	Leakage (S3)			hhh/iii
	(Required only			Example: S3:p/9/49/49/10/
	when AC Power			50/50/100/499/750
	module is used.)
		ECG Patient Cable	If readings are as expected:
		• Source	• < 10 uA
		(Normal Condition) - aa
		• Source (Single Fault	• < 50 uA
		Condition - open earth,
		open neutral) - bb
		• With Mains on applied part	• < 50 uA
		(Single Fault condition) - cc	then Safety Patient Lead
			Leakage test passes
		SPO2	If readings are as expected:
		• Source	• < 10 uA
		(Normal Condition) - dd
		• Source (Single Fault	• < 50 uA
		Condition - open earth,
		open neutral) - ee
		With Mains on applied part	• < 50 uA
		(Single Fault condition) - ff	then Safety Patient SPO2
			Leakage test passes.

2-6	Performance Verification and Safety Tests

			Test and Inspection Matrix
Table 2-1 Performance Verification and Safety Tests (Continued)
Test Group Name	Test or Inspection to	Expected Test Results	Data to Record
	Perform		P (pass) or F (fail)
	Pads	If readings are as expected:
	• Source	< 100 uA
	(Normal Condition) - ggg
	• Source (Single Fault	< 500 uA
	Condition) - hhh				2
	• With Mains on applied part	< 5000 uA
	(Single Fault condition) - iii	then Safety Pads Test
		passes
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

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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 ECG simulator
• Amplitude accuracy	±2%
• Rate accuracy	±2%
Calibrated Paddles ECG simulator
• Amplitude accuracy	±2%
• Rate accuracy	±2%
Defibrillator Analyzer
Waveform compatibility	Meets all specs below using biphasic
	truncated exponential waveform.
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
Cardioversion measurement range:	–150 to +150 ms

2-8	Performance Verification and Safety Tests

		Test Equipment
Table 2-2 Equipment List
Equipment/Test		Specifications
Pacer tester
Load impedance:	≤400 Ω
Current measurement accuracy
• 10 mA–50 mA:	<±2 mA
• 50 mA–200 mA:	<±4%			2
Rate measurement accuracy
• 30–180 ppm:	<±0.5%
Waveform duration accuracy:
• 30–180 ppm:	±1ms

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2-9

Configuration and Diagnostic Modes

CAUTION

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.

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.

zTo select a configuration, press the and softkeys to move up or down the list until the desired Settings item is highlighted. Then press the ENTER softkey to access those settings.

zTo print out a strip with all the current configuration choices, select

Print All Settings and press ENTER .

zTo store the configuration settings on a data card, select Save Settings to Data Card and press ENTER . When prompted with Save Settings to Data Card? press SAVE .

zTo load configuration settings from a Data Card, select Load Settings from Data Card and press ENTER . When prompted with Load Settings from Data Card? press LOAD .

5.Exit Configuration Mode.

zTo exit Configuration Mode, turn the unit off.

zWait 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