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 (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 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
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.
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.
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.
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Batteries, Power Modules, Battery Charger Adapter |
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The M3500B/M5500B is powered by a rechargeable Sealed Lead Acid (SLA) |
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battery (M3516A/M5516A). Proper care of these batteries will ensure that |
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they have the energy required to operate the M3500B/M5500B and deliver the |
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appropriate therapy (See "Battery Maintenance" section in Instructions for |
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Use). |
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Batteries may be charged either in the defibrillator or in the Battery Charger |
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Adapter (M3506A/M5506A). In either case, power for charging can be pro- |
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vided by the AC Power Module (M3517A/M5517A), or by the DC Power |
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Module (M3518A/M5518A). |
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NOTE |
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The |
defibrillator will take longer to charge when powered with either power |
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module without a battery installed. The recommended practice is to use a bat- |
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tery in conjunction with the power module to ensure optimal performance. |
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For information on either the power modules or the adapter, see the documen- |
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tation supplied with the power module or adapter. |
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Installation |
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The M3500B/M5500B does not require installation. The Instructions for Use |
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describes the setup required before placing the device into service, as well as |
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configuration options. |
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Upgrades |
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Upgrades are available to add specific functionality to units in the field. As of |
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the publication of this manual, these upgrades are: |
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z M3514A Pacing Upgrade (adds pacing) |
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z M3515A SpO2 upgrade. |
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Consult your sales representative or dealer or distributor for the latest details. |
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Preventive Maintenance |
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Preventive maintenance and periodic operational checks are intended to be |
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performed by the user. Both topics are covered in the Maintenance chapter of |
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the Instructions for Use. |
1-2 |
Introduction |
Overview
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Repair Philosophy |
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Defibrillator/Monitor |
1 |
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The repair philosophy of the M3500B/M5500B is subassembly replacement. |
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Examples of subassemblies are the printer, the Control Printed Circuit Assem- |
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bly (PCA), and selected connectors and other items. Repairs that involve |
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replacing components on a PCA are not supported. |
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CAUTION |
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Individual component replacement should not be attempted outside of a fac- |
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tory authorized repair facility. Component level repair is extremely difficult |
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due to the extensive use of surface mount technology and the high parts-den- |
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sity on the circuit boards. Unauthorized component replacement can impair |
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performance of the M3500B/M5500B. |
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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 |
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Overview |
2 |
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This chapter describes the tests and inspections required to verify perfor- |
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mance of the M3500B/M5500B Defibrillator/Monitor. |
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The information is presented in the following sequence: |
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Test Matrix |
A list of the tests required to verify per- |
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formance of the M3500B/M5500B, |
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along with expected test results. |
Test Equipment |
A list of commercially available test, cal- |
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ibration and simulation devices needed |
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to perform performance verification |
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tests. |
Performance Verification |
Step-by-step instructions for performing |
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each of the Performance Verification |
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Tests. |
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 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).
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).
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 |
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2 |
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Test Group Name |
Test or Inspection to |
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Expected Test Results |
Data to Record |
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Perform |
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P (pass) or F (fail) |
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Visual Inspection |
Inspect unit, accessories, |
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• If no unusual damage, no |
Example VI:p |
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(VI) |
cables, etc. as described on |
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corrosion, no missing |
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page 2-12. |
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items, |
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then Visual Inspection |
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passes |
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Functional |
In normal Operating Mode, |
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• If all functions respond as |
Example F:p |
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Checks (F) |
perform the following func- |
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expected: |
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tional checks: |
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• ECG (page 2-13). |
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• Waveform clear on dis- |
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play; HR correct on display; |
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HR alarm works. Leads off, |
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pads off indicators as |
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expected. |
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• Shock Advisory (page 2- |
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• Shock Advised only when |
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14). |
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appropriate |
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• Synchronized Cardiover- |
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• Shock delivered with cor- |
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sion (page 2-14). |
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rect timing (< 60msec) |
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• SpO2 (page 2-15). |
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• 95% -100% |
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then Functional test passes |
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Extended Self |
In Diagnostic Mode, run the |
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If "Pass" reported on all |
Example X:p |
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Test (X) |
Extended Self Test (page 2- |
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tests applicable to the device |
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17). Includes Data Card Test |
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configuration and options, |
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and time/date check. |
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then Extended Self test |
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passes |
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M3500B/M5500B Service Manual |
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 |
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Perform |
P (pass) or F (fail) |
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User Interface |
• In Diagnostic Mode, run |
If all responses as expected: |
Example: U:p |
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Tests (U) |
the following tests |
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(page 2-19): |
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• Controls Test |
• All keys respond as |
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expected |
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• Display Test |
• Display goes dark, then |
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light. Black vertical bar |
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scrolls across the screen |
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from left to right. |
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• Audio Test |
• Alerts, alarms, and tones |
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are clearly heard |
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• Printer Test |
• Print quality is adequate; |
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no stray marks or lines |
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• Print speed: 25 mm + 5% |
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(1.25mm) |
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then User Interface test |
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passes |
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ECG Tests (E) |
In Diagnostic Mode, run the |
If all data within limits, all |
Example:E:p |
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ECG Tests (page 2-22): |
checks pass: |
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• Status messages (lead, |
• "Good" displayed for all |
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pad, DSP) |
three status messages |
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PCI measurement |
If all PCI measurements are |
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within the following ranges: |
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• PCI - Test Load attached |
• 50 ± 30 Ω |
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• PCI - Pads open |
• > 2000 Ω |
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then ECG test passes |
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Pacing Test (P) |
In Diagnostic Mode, run the |
If measurement is within the |
Example: P:p |
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Pacing Test (page 2-25): |
following limit: |
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• 200 mA |
• 200 mA± 20 mA |
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then Pacing test passes |
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2-4 |
Performance Verification and Safety Tests |
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Test and Inspection Matrix |
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Table 2-1 Performance Verification and Safety Tests (Continued) |
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Test Group Name |
Test or Inspection to |
Expected Test Results |
Data to Record |
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Perform |
P (pass) or F (fail) |
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Defibrillator Test - |
Using only the AC or DC |
If the measurements are as |
Example: DM:p |
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AC or DC Power |
power module, enter Diag- |
follows: |
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Module (DM) |
nostic Mode and run the |
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(Required only |
Defibrillator Test (at |
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when AC or DC |
200Joules) (page 2-27): |
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power module |
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2 |
used.) |
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Displayed by |
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M3500B/M5500B: |
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• Available Energy after |
• 0 |
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Shock |
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• Msec to charge |
• < 15000 msec |
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• Delivered energy |
• Actual delivered energy |
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200 +7% |
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• Impedance |
• 42 to 57 Ω |
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• Defib errors |
• None (0) |
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then the Defibrillator test |
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(Power Module) passes |
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Defibrillator Test - |
Using only battery power, |
If the measurements are as |
Example: DB:p |
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Battery Power |
enter Diagnostic Mode and |
follows: |
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(DB) |
run the Defibrillator Test (at |
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200Joules) (page 2-28). |
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Displayed by |
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M3500B/M5500B |
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• Available Energy after |
• 0 |
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Shock |
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• Msec to charge |
• < 3000 msec |
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• Delivered energy |
• Actual delivered energy |
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200 +7% |
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• Impedance |
• 42 to 57 Ω |
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• Defib errors |
• None (0) |
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then the Defibrillator test |
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(Battery Power) passes |
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Defibrillator |
Enter Diagnostic Mode and |
If all readings as expected |
Example: D:p |
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Disarm Test (D) |
run the Defibrillator Disarm |
Available energy - failure >0 |
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Test (page 2-29) |
No errors reported |
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then the Defibrillator Disarm |
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test passes |
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M3500B/M5500B Service Manual |
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 |
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Perform |
P (pass) or F (fail) |
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Safety Tests |
Indicate test results as |
Note: All Safety tests include |
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follows: |
both Normal and Reverse |
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Polarity conditions. |
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Earth Leakage |
Earth Leakage Current NC |
If NC maximum leakage |
Example: S1:p/200/300 |
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Current (S1) |
(Normal Condition) |
current: |
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(Required only |
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< 300 uA (UL), <500 uA |
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when AC Power |
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and |
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module is used.) |
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Earth Leakage SF |
If SF maximum leakage |
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(Single Fault - open neutral) |
current: |
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< 1000 uA |
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then S1 test passes |
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Patient Lead |
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S3:p/aa/bb/cc/dd/ee/ff/ggg/ |
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Leakage (S3) |
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hhh/iii |
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(Required only |
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Example: S3:p/9/49/49/10/ |
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when AC Power |
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50/50/100/499/750 |
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module is used.) |
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ECG Patient Cable |
If readings are as expected: |
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• Source |
• < 10 uA |
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(Normal Condition) - aa |
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• Source (Single Fault |
• < 50 uA |
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Condition - open earth, |
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open neutral) - bb |
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• With Mains on applied part |
• < 50 uA |
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(Single Fault condition) - cc |
then Safety Patient Lead |
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Leakage test passes |
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SPO2 |
If readings are as expected: |
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• Source |
• < 10 uA |
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(Normal Condition) - dd |
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• Source (Single Fault |
• < 50 uA |
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Condition - open earth, |
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open neutral) - ee |
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With Mains on applied part |
• < 50 uA |
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(Single Fault condition) - ff |
then Safety Patient SPO2 |
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Leakage test passes. |
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2-6 |
Performance Verification and Safety Tests |
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Test and Inspection Matrix |
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Table 2-1 Performance Verification and Safety Tests (Continued) |
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Test Group Name |
Test or Inspection to |
Expected Test Results |
Data to Record |
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Perform |
P (pass) or F (fail) |
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Pads |
If readings are as expected: |
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• Source |
< 100 uA |
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(Normal Condition) - ggg |
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• Source (Single Fault |
< 500 uA |
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Condition) - hhh |
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2 |
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• With Mains on applied part |
< 5000 uA |
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(Single Fault condition) - iii |
then Safety Pads Test |
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passes |
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Note: When recording test results, separate results within a test by slashes; separate tests by a semicolon (;); and |
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do not use empty spaces. For example: |
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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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M3500B/M5500B Service Manual |
2-7 |
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 |
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ECG Simulator |
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Calibrated Leads ECG simulator |
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• Amplitude accuracy |
±2% |
• Rate accuracy |
±2% |
Calibrated Paddles ECG simulator |
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• Amplitude accuracy |
±2% |
• Rate accuracy |
±2% |
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Defibrillator Analyzer |
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Waveform compatibility |
Meets all specs below using biphasic |
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truncated exponential waveform. |
Load resistance: |
50 Ω ±1% (non-inductive) |
Maximum energy: |
≥ 200 joules |
Maximum voltage: |
≥ 2500 V |
Maximum current: |
≥50 A |
Measurement accuracy: |
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• ≥ 20 joules: |
≤ ±2% of reading |
• < 20 joules: |
≤ ±0.4 joules |
Cardioversion measurement range: |
–150 to +150 ms |
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2-8 |
Performance Verification and Safety Tests |
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Test Equipment |
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Table 2-2 Equipment List |
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Equipment/Test |
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Specifications |
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Pacer tester |
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Load impedance: |
≤400 Ω |
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Current measurement accuracy |
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• 10 mA–50 mA: |
<±2 mA |
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• 50 mA–200 mA: |
<±4% |
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2 |
Rate measurement accuracy |
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• 30–180 ppm: |
<±0.5% |
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Waveform duration accuracy: |
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• 30–180 ppm: |
±1ms |
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M3500B/M5500B Service Manual |
2-9 |
CAUTION
Configuration and Diagnostic Modes
The instructions below describe how to enter Configuration Mode and Diagnostic 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 |