Philips Agilent Heartstream XL Service manual

Service Manual
M4735A Defibrillator/Monitor
Verification Draft 29 June 2000
Notice
About This Edition
Edition 1 Printed in the USA Publication number M4735-90900
The information in this manual appli es to the M4735A Heartstream XL Release A.0.0. This informatio n is sub­ject to change without notice.
Agilent Technologies shall not be liabl e 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, July, 2000
Copyright
Copyright © 2000 Agilent Technologies, Inc. 3000 Minuteman Road Andover, MA 01810-1099 USA (978) 687-1501 This document ma y not be photoc opied,
reproduced, or translated to another lan­guage without prior written consent of Agilent Technologies.
WARNING
Radio Frequency (RF) interference from nearby transmitting devices may seriously degrade performance of the M4735A. Electromagnetic compatibil­ity with surrounding devices should be assessed prior to using the defibrillator.
CAUTION
Use of supplies or accessories other than those recommended by Agilent Technologies 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 M4735A Defibrillator/Monito r complies with the requirements of the Medical Device Directive 93/42/EEC
and carries the ingly.
Authorized EU-representative: Agilent Technologies GmbH Herrenbergerstrasse 130 D-71034 Boeblingen, Germany Fax: +49-7031-14-2346
mark accord-
0123
ii
Conventions
This manual uses the following text conventions:

Printed and On-Line

NOTE Notes contain additional information on servicing this product.
CAUTION Caution statements descr ibe cond ition s or acti ons that can resu lt in damag e to
the equipment or loss of data.
WA RN I N G Warning statements describe conditions or actions that can result in personal injury
or loss of life.
Te x t
Softkey

On-Line Only

Hypertext

represents messages that appear on the display represents softkey labels that appear on the display
above or below the button to which they correspond
represent hypertext links, which will display as blue; click on the link to go t o that d estin ation, then cl ick on the destination to return.
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iv
Contents
Conventions
Printed and On-Line .......................................................................................................... iii
On-Line Only ................................................................................................................. iii
Hypertext ..........................................................................................................................iii
Introduction
Overview ....................................................................................................................1-1
Defibrillator/Monitor ...................................................................................................... 1-1
Batteries .......................................................................................................................... 1-2
Installation ......................................................................................................................1-2
Upgrades ......................................................................................................................... 1-2
Preventive Maintenance .................................................................................................. 1-2
Repair Philosophy ........................................................................................................... 1-3
Performance Verification and Safety Tests
Overview .........................................................................................................................2-1
Chapter Contents ............................................................................................................. 2-1
Mandatory Testing ......................................................................................................2-2
External Repairs/No Trouble Found ............................................................................... 2-2
Printer ..............................................................................................................................2-3
Internal Repairs ...............................................................................................................2-3
Test Matrix .................................................................................................................2-4
Test Equipment ...........................................................................................................2-8
Configuration and Diagnostic Modes ......................................................................2-10
Configuration Mode ...................................................................................................... 2-10
Diagnostic Mode ........................................................................................................... 2-11
The Software Support Tool ......................................................................................2-12
Using the Support Tool ................................................................................................. 2-12
Performance Verification .........................................................................................2-14
Visual Inspection ........................................................................................................... 2-15
Functional Checks ......................................................................................................... 2-16
Diagnostic Tests ............................................................................................................ 2-19
Safety Tests ..................................................................................................................2-39
Battery Capacity Test ....................................................................................................2-40
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Contents
Troubleshooting
Overview .........................................................................................................................3-1
Chapter Contents ............................................................................................................. 3-1
Repair Philosophy ........................................................................................................... 3-1
Equipment Required .......................................................................................................3-1
Troubleshooting and Repair Methodology ................................................................3-2
Methodology Overview .................................................................................................. 3-2
Initial Assessment ......................................................................................................3-3
Diagnosing External Failures .....................................................................................3-4
Diagnosing Internal Failures ......................................................................................3-5
Troubleshooting Tables ..............................................................................................3-6
Using the Tables ............................................................................................................. 3-6
General Problems .......................................................................................................3-8
Unit Unresponsive .......................................................................................................... 3-8
Error Codes ................................................................................................................... 3-10
System Messages .......................................................................................................... 3-12
Momentary Messages ...................................................................................................3-14
Audio Tones ................................................................................................................ 3-16
Extended Self Test Failures .......................................................................................... 3-17
Operational Problems ...............................................................................................3-18
ECG Monitoring ......................................................................................................... 3-18
SpO2 Monitoring .......................................................................................................... 3-20
Defibrillation and Cardioversion .................................................................................3-21
Pacing ............................................................................................................................3-24
Printer ........................................................................................................................... 3-25
Display .......................................................................................................................... 3-26
Audio ............................................................................................................................3-27
Keys .............................................................................................................................3-28
Battery and Charging Circuits ...................................................................................... 3-29
Data Card ......................................................................................................................3-30
Calling for Service ................................................................................................... 3-31
United States of America ..............................................................................................3-31
Canada ..........................................................................................................................3-31
Other International Areas .............................................................................................. 3-31
Equipment Information ................................................................................................. 3-31
Removal and Replacement
Overview .........................................................................................................................4-1
Chapter Contents ............................................................................................................. 4-1
Servicing Notes ..........................................................................................................4-1
Key Components ............................................................................................................. 4-1
Removal, Handling, and Replacement ........................................................................... 4-2
Tool Requirements .......................................................................................................... 4-3
vi
Contents
Disposal ..........................................................................................................................4-3
External Assemblies ...................................................................................................4-4
User-replaceable Parts and Accessories .......................................................................... 4-5
User Maintenance ...........................................................................................................4-5
Printer Assembly ............................................................................................................. 4-6
Battery Cover ................................................................................................................ 4-10
Main Fuse ..................................................................................................................... 4-12
Battery Eject Assembly ................................................................................................ 4-14
Data Card Door .............................................................................................................4-16
Energy Select Knob ....................................................................................................4-17
Paddle Holders .............................................................................................................. 4-18
Labels ............................................................................................................................4-20
Label Descriptions ........................................................................................................ 4-20
Removing and Replacing Labels .................................................................................. 4-22
Opening the Case ..................................................................................................... 4-24
Discharge the Power Supply Capacitors ...................................................................... 4-24
Separate the Case ........................................................................................................ 4-26
Discharge the Defibrillator Capacitor .......................................................................... 4-30
Identifying Internal Subassemblies ...............................................................................4-32
Internal Assemblies - Top Case ................................................................................4-33
Lithium Backup Battery ................................................................................................ 4-34
Control PCA ................................................................................................................ 4-36
Shield Plate ...................................................................................................................4-40
Keyscan PCA ................................................................................................................ 4-42
Bezel Assembly .......................................................................................................... 4-48
Energy Select Switch .................................................................................................... 4-52
......................................................................................................................................4-53
Display Assembly .........................................................................................................4-54
Parameter PCA ............................................................................................................. 4-56
SpO2 PCA .................................................................................................................. 4-58
ECG Connector ............................................................................................................. 4-60
SpO2 Connector ............................................................................................................ 4-62
Speaker ....................................................................................................................... 4-64
AC Mains Connector ....................................................................................................4-66
ECG Out (Sync) Connector .......................................................................................... 4-69
Pacer Keypad ................................................................................................................ 4-70
Replacement Top Case .................................................................................................. 4-75
Internal Assemblies - Bottom Case ..........................................................................4-79
Battery PCA .................................................................................................................. 4-80
Defibrillator Capacitor ..................................................................................................4-84
Power PCA ................................................................................................................... 4-86
AC Power Module ........................................................................................................4-90
Patient Connector .......................................................................................................... 4-94
Replacement Bottom Case ............................................................................................ 4-97
Closing the Case .......................................................................................................4-99
vii
Contents
Replacement Parts
Overview .........................................................................................................................5-1
Chapter Contents ............................................................................................................. 5-1
Ordering Replacement Parts .......................................................................................... 5-1
Ordering Supplies and Accessories ................................................................................ 5-1
Key Components ........................................................................................................... 5-2
Calling for Service ..................................................................................................... 5-3
United States of America ...........................................................................................5-3
Canada ........................................................................................................................ 5-3
Other International Areas ............................................................................................ 5-3
Special Tools ..............................................................................................................5-4
M4735A Unit Exchange Program ..............................................................................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 ............................................................................................... 5-9
Mechanical Assemblies ............................................................................................5-10
Bezel Assembly ............................................................................................................ 5-10
Pacer Keypad Assembly ............................................................................................... 5-11
Other Mechanical Assemblies ......................................................................................5-12
Connector Assemblies .................................................................................................. 5-12
Individual Mechanical Parts ......................................................................................... 5-13
Labels .......................................................................................................................5-14
Instruction Label Sets ................................................................................................... 5-14
Case Label Sets ............................................................................................................. 5-16
Other Labels .................................................................................................................5-17
Supplies & Accessories ............................................................................................5-18
Key Components ......................................................................................................5-21
Theory of Operation
Overview .........................................................................................................................6-1
PCA Descriptions .......................................................................................................6-2
Control PCA ................................................................................................................... 6-2
Power PCA ..................................................................................................................... 6-3
Parameter PCA ............................................................................................................... 6-3
Keyscan PCA .................................................................................................................. 6-3
SpO2 PCA .......................................................................................................................6-4
Battery PCA ....................................................................................................................6-4
Battery .............................................................................................................................6-4
AC Power Module ..........................................................................................................6-4
Printer ..............................................................................................................................6-4
viii
Contents
System Level Interconnections ..................................................................................6-5
System Functional Descriptions ............................ .................. ................... ................ 6-6
Signal and Data Flow ...................................................................................................... 6-6
ECG Monitoring Functions ............................................................................................ 6-7
Patient impedance functions ........................................................................................... 6-7
SpO2 Monitoring Functions ...........................................................................................6-8
Defibrillation Functions .................................................................................................. 6-9
Pacing Functions ........................................................................................................... 6-11
Audio Functions ............................................................................................................ 6-11
Display Functions ......................................................................................................... 6-11
Indicator Functions .......................................................................................................6-11
Key Functions ............................................................................................................... 6-11
Energy Select Switch .................................................................................................... 6-12
Printing Functions ......................................................................................................... 6-12
Battery/Power Functions ............................................................................................... 6-12
Lithium Backup Battery ................................................................................................ 6-15
Data Card ......................................................................................................................6-15
Specifications
Overview .........................................................................................................................7-1
Specifications .............................................................................................................7-1
Defibrillator ....................................................................................................................7-1
ECG Monitoring ............................................................................................................. 7-3
Display ............................................................................................................................ 7-4
Battery .............................................................................................................................7-4
Thermal Array Printer .....................................................................................................7-5
Noninvasive Pacing ........................................................................................................ 7-6
SpO2/Pulse Oximetry ...................................................................................................... 7-6
Event Storage ..................................................................................................................7-6
General ............................................................................................................................7-7
Environmental .................................................................................................................7-7
Waveforms - 150J ......................................................................................................7-8
Waveforms - 200J .................................................................................................7-11
Symbol Definitions ..................................................................................................7-14
Safety Considerations ...............................................................................................7-16
Electromagnetic Compatibility ................................................................................7-19
Reducing Electromagnetic Interference ........................................................................ 7-19
Restrictions for Use ...................................................................................................... 7-20
Immunity Level ............................................................................................................. 7-20
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Contents
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x

1Introduction

This Service Manual provides the information needed to successfully service the Agi­lent M4735A Heartstrea m XL Defi bril lato r/Mon itors . The i ntende d user s of t his man ­ual are technical personnel who have been trained in the safe and proper servicing of the M4735A. 1

Overview

In this chapter, you’ll find general information that you should become famil­iar with before servicing the M4735A. Detailed information regarding con­trols, operation, and capabilities of the instrument can be found in the User’s
Guide (M4735-91900) that was shipped with the product. We recommend you review the User’s Guide before servicing this device. Th is Service Man - ual assumes you are familiar with the controls and with basic operations.

Defibrillator/Monitor

The M4735A is a biphasic, semi-automatic external defibrillator. This porta­ble, lightweight device offers two modes of operation for defibrillation:
l
Semi-Autom atic External Defibrillat ion (AED) Mode
l
Manual Mode
1
In AED Mode, the M4735A analyzes the patient’s ECG and advises the clini­cian whether or not to deliver a shock. Defibrillation is performed through multifunction defi b electrode pads.
In Manual Mode, the M4735A turns control of the defibrillation process over to the clinician. The c li ni ci an a nal yze s the patient’s ECG, decides if defibrilla­tion is advised, and deter mines t he ener gy s etti ng for def ibrill ation . Defibr illa ­tion is performed eit her through mu ltifunc tion defib el ectrode pa ds or throu gh paddles.
Manual Mode also allows the c linician to perform synchroni zed cardiover sion and offers optional noninvasive pacing (using a monophasic waveform).
ECG monitoring can be accomplished in either mode using one of 3 methods:
l
ECG from the defib pads
l
3-lead ECG using separate monitoring electrodes
l
Optional 5-lead ECG using separate monitoring electrodes.
Optional pulse oximetry (SpO well.
The M4735A automatically stores critical events, such as shocks and alarm violations, in its internal memo ry. An Event Summary may be printed at any time. The M4735A also enables you to store data and events on an M3510A
) monitoring is available in both modes, as
2
1-1
6/29/00
Overview
Data Card for downloading to the CodeRunner Web Data Management Sys­tem.

Batteries

The M4735A is powered by a rechargeable Sealed Lead Acid (SLA) battery (M3516A). Proper care of these batteries will ensure that they have the energy required to operate the M4735A and deliver the appropriate therapy (See "Battery Maintenance" section in User’s Guide).
NOTE The defibrillator will take longer to charge when powered with AC without a
battery installed. To ensure optimal performance, alwa ys have a fully char ged battery in the defibrillator, even when using AC power.

Installation

The M4735A does not require installation. The User’s Guide describes the setup required before pla ci ng the devi ce into service, as well as configuration options.

Upgrades

Upgrades are availabl e to add spe cific funct ionalit y to units in the fi eld. As of the publication of this manual, these upgrades are:
l
M4738A Pacing Upgrade (adds pacing).
l
M4739A SpO2 upgrade. (adds SpO2).
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 i n the Ma inten ance cha pter o f the User’s Guide.
1-2 Introduction
Overview

Repair Philosophy

Defibrillator/Monitor
The repair philosophy of the M4735A i s subassembly repl acement. Examp les of subassemblies are the printer, the Control Printed Circuit Assembly (PCA), and selected connectors and other items. Repairs that involve replacing com­ponents on a PCA are not supported.
CAUTION Individual component replacement should not be attempted outside of a fac-
tory authorized repair facility. Component level repair is extremely difficult due to the extensive use of surface mount technology and the high parts-den­sity on the circuit boards. Unauthorized component replacement can impair performance of the M4735A.
Batteries
The repair philosophy for the SLA battery (M3516A) is unit replacement. These items are not repaired in the field.
For information on ordering replacements, see "Supplies & Accessories" on page 5-18.
1
M4735A Service Manual 1-3
Overview
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1-4 Introduction

2 Performance Verification and Safety Tests

Overview

This chapter describes the tests and inspections required to verify perfor­mance of the M4735A Portable Defibrillator/Monitor.

Chapter Contents

The major sections of this ch apter are as fo llows:
Section Page
Mandatory Testing 2-2 Test Matrix 2-4 Test Equipment 2-8 Configuration and Diagnostic Modes 2-10 The Software Support Tool 2-12 Performance V eri fic ati on 2-14
2
2-1
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Mandatory Testing

Mandatory Testing
The Performa nce Verification Tests in this chapter are intended to verify proper operation of the M4735A following repair. The level of testing required corresponds to the t ype of r epair p erforme d, and is divide d into 3 c at­egories: External/No Trouble Found, Printer Replacement, and Internal Repairs. Each of these categories is described below.

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.
l
External paddles
l
Internal paddles and/or adapter cable
l
Paddle holders
l
Pads adapter cable
l
ECG cable
l
SpO2 cable or sensor
l
Battery
l
Labels
l
AC Power cord
l
Consumables (ECG monitoring electrodes, multifunction defibrilla­tion pads, printer paper)
l
Main fuse (on Battery PCA)
l
Data Card Door Assembly
l
Battery Ejec t Assembly
The following testing is required after an External Repair or when the out- come of the service is No Trouble Found (when the case has not been opened):
l
Perform the Visual Inspection (page 2-15).
l
Run the Extended Self Test (page 2-22).
l
Print and Verify the System Log (page 2-20).
2-2 Performance Verification and Safety Tests
Mandatory Testing

Printer

If the printer was replaced , and the case was not opened, the following tests are required:
l
Perform the Visual Inspection (page 2-15).
l
Run the Extended Self Test (page 2-22).
l
Run the Printer Test (page 2-27).
l
Print and Verify the System Log (page 2-20).

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 2-15.
2
M4735A Service Manual 2-3

Test Matrix

Test Matrix
The matrix in Table 2-1 summarizes performance verification tests and inspections for the M4735A; including test name, test or inspection to per­form, expected test results, and data to record.
Table 2-1 Performance Verification and Safety Tests
Test Group Name
Visual Inspection (V)
Functional Checks (F)
Extended Self Test (X)
Test or Inspection to
Perform
Inspect unit, accessor ies, cables, etc. as described on page 2-15.
In normal Operating Mode, perform the following func­tional checks:
ECG (page 2-16). W aveform c lear on displa y;
Shock Advisory (page 2-
17).
Synchronized Cardiover­sion (page 2-18).
(page 2-18). 95% -100%
SpO
2
In Diagnostic Mode, run the Extended Self Test (page 2-22). Includes Data Card Test and time/date check.
Expected Test Results
No unusual damage, no corrosion: x=p.
All functions respond as expected
HR correct on display; HR alarm works
Shock Advised only when appropriate
Shock delivered with cor­rect timing
"Pass" reported on all tests applicable to the device con­figuration and options: x=p.
Data to Record
x = p (pass) or f(fail)
V:x
Example V:p
F:x Example F:p
X:x
Example X:p
User Interface Tests (U)
• In Diagnostic Mode, run the following tests (page 2-25):
Controls Test All keys respond as
Display Test Visual Pass assessment by
Audio Test • Audio Pass assess ment by
Printer Test • Print quality: visual Pass
All responses as expected.
expected
service personnel
service personnel.
assessment by serv ice per­sonnel
Print speed: 25 mm (1.25mm)
± 5%
U:x Example: U:p
2-4 Performance Verification and Safety Tests
Table 2-1 Performance Verification and Safety Tests
Test Matrix
Test Group Name
ECG Tests (E) In Diagnostic Mode, run
Test or Inspection to
Perform
the ECG T ests (page 2-29):
Status messages (lead, pad, DSP)
DC offset Ignore - used only in fac-
Amplifier gain
Pads Peak to Peak (Moni­tor) - aaaa
Leads Peak to Peak (Diag­nostic) - bbbb
Amplifier noise
Leads Peak to Peak (Diag­nostic) - cc
Pads Peak to Peak (Moni­tor) - dd
Expected Test Results
All data within limits, all checks pass: x=p
"Good" displayed for all three
tory manufacturing.
1000mV ±10%
1000mV
0 ± 30uV
0 ± 30uV
±10%
Data to Record
x = p (pass) or f(fail)
E: aaaa,bbbb,cc,dd, ee,fff f,x
Example: E:1000,1000,20,20, 50,2000,p
2
PCI measurement
PCI - Paddles in Pockets – ee• 50 ± 30
PCI - Paddles open – ffff >
Pacing Test (P) In Diagnostic Mode, run
the Pacing Test (page 2-
33):
30 mA – aa 30 mA ± 5 mA
200mA – bbb 200mA± 20 mA
1250
P:aa,bbb
Example: P:31,198
M4735A Service Manual 2-5
Test Matrix
Table 2-1 Performance Verification and Safety Tests
Test Group Name
Defibrillator T es t ­AC Power (DA)
(if AC Power used in normal opera­tion)
Test or Inspection to
Perform
Using only AC power, enter Diagnostic Mode and run the Defibrillator Test (AC Power at 200J) (page 2-35):
Expected Test Results
Measured by Defibrillator Analyzer:
Delivered energy - aaa
200
± 30J
Displayed by M4735A:
Available Energy after Shock
Msec to charge – bbbbb <
Delivered energy - ccc Actual delivered energy
Impedance - dd 42 to 57
Defib errors None (0)
0
15000 msec
(aaa) ±7%
Data to Record
x = p (pass) or f(fail)
DA:aaa,bbbbb,ccc,dd
Example: DA:198,13000,195 ,48
Defibrillator T es t ­Battery Power (DB)
Defibril lator Dis­arm Test (D)
Using only battery power, enter Diagnostic Mode and run the Defibrillator Test (Battery Power at 200J) (page 2-36).
Measured by Defibrillator Analyzer
Delivered energy - aaa 200 ± 30 J
Displayed by M4735A
Available Energy after Shock
Msec to charge – bbbb <
Delivered energy - ccc Actual delivered energy
Impedance - dd 42 to 57
Defib errors None (0)
Enter Diagnostic Mode and run the Defibrillator Disarm Test (page 2-38)
0
3000 msec
(aaa)
±7%
All readings as expected: x=p
DB:aaa,bbbb,ccc,dd
Example: DB:198,2545,200,50
D:x
Example: D:p
2-6 Performance Verification and Safety Tests
Table 2-1 Performance Verification and Safety Tests
Test Matrix
Test Group Name
Safety Test (S) Test both leads and pads,
Test or Inspection to
Perform
and indicate test results as follows: External Leads: t=C External Pads: t=B
Earth Leakage
Earth Leakage (Normal Co ndition) - aaa
Earth Leakage (Single Fault) - bbbb
Patient Lead Leakage
Source (Normal Condition) - ccc
Source (Single Fault Condition) ­ddd
With Mains on appli ed p art (Single Fault condition) ­eeee
Expected Test Results
< 500 uA (< 300 uA UL)
<
1000 uA
CF/ BF Applied Parts < 10 uA/100 uA
<
50 uA/500 uA
50 uA/5000 uA
<
Data to Record
x = p (pass) or f(fail)
S:aaa,bbbb, t,ccc,ddd,eeee,fff,ggg; t,ccc,ddd,eeee,fff,ggg
Example: S:125,150, C,10,40,40,10,40; B,90,150,2500,90,250
2
Auxiliary (Normal Condition) - fff
Auxiliary (Single Fault Condition) ­ggg
Note: All leakage current tests include both Normal and Reverse Polarity Condi­tions. Report worst case values.
Note: When recording test results, separate results within a test by commas; separate tests by a semicolon (;); and use no empty spaces. For example:
V:x;F:x;X:x;U:x;E: aaaa,bbbb,cc,dd,ee,ffff,x;P:aa,bbb; DA:aaa,bbbbb,ccc,dd;DB:aaa,bbbb,ccc,dd;D:x; S:aaa,bbbb,t,ccc,ddd,eeee,fff,ggg;t,ccc,ddd,eeee,fff,ggg
V:p;F:p;X:p;U:p;
DA:198,13000,195,48;DB:198,2545,200,50;D:p; S:125,150,C,10,40,40,10,40;B,90,150,2500,90,250
E:1000,1000,20,20,50,2000,p;P:31,198;
< 10 uA/100 uA
<
50 uA/500 uA
M4735A Service Manual 2-7

Test Equipment

Test Equipment
Table 2-2 lists the equipment needed to pe rf orm t he 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 Agilent Technologies (M1781A).
Table 2-2 Equipment List
Equipment/Test Specifications
ECG Simulator
Calibrated Leads ECG simulator
Amplitude accuracy ±2%
Rate accuracy ±2%
Calibrated Paddles
Amplitude accuracy ±2%
Rate accuracy ±2%
Defibrillator Analyzer
Waveform compatibility Meets all specs below using biphasic
Load resistance: 50 ±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
ECG simulator
truncated exponential waveform.
2-8 Performance Verification and Safety Tests
Table 2-2 Equipment List
Equipment/Test Specifications
Pacer tester
Load impedance: 400
measurement accuracy
Current
30 mA–50 mA: <±2 mA
50 mA–200 mA: <±4%
measurement accuracy
Rate
40–180 ppm: <±0.5% Waveform duration accuracy:
40–180 ppm: ±1ms
Test Equipment
2
M4735A Service Manual 2-9

Configuration and Diagnostic Modes

Configuration and Diagnostic Modes
The instructions below describe how to enter Configuration Mode and Diag­nostic Mode.

Configuration Mode

These instructions describe briefly how to use Configuration Mode. See the User’s Guide for details on configuration settings and what effect they have.
1. Power off.
Make sure the unit’s power is off.
2. Insert a 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.
NOTE To avoid possible confusion, designate one Data Card as the "Configuration
Card" and label it c le arl y. Keep this card physically separate from cards used by the clinical staf f 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.
l
To select a configuration, press the and softkeys to move up
ENTER
Settings
item is highlighted. Then
Save Settings
Save Settings to
or down the list until the desired press the softkey to access those settings.
l
To print out a strip with all the current configuration choices, select
Print All Settings
l
To store the configuration settings on a data card, select
to Data Card
Data Card? press .
l
To load configuration settings from a Data Card, select Load Settings
ENTER
and press .
and press . When prompted with
SAVE
from Data Card and pres s . When pr ompte d wi th Load Settings from Data Card? press .
5. Exit Configuration Mode.
ENTER
ENTER
LOAD
To exit Configuration Mode, turn the unit off. Remove the Data Card.
2-10 Performance Verification and Safety Tests
Figure 2-1 Softkey Numbers
Softkeys 4 5 6 7
Configuration and Diagnostic Modes
2

Diagnostic Mode

These instructions describe how to enter Diagnostic Mode. Once in Diagnos­tic Mode, you can do the following:
l
Print the System Log. See "System Log" on page 2-20.
l
Run the Extended Self Test. See "Extended Self Test" on page 2-22.
l
Run other Diagnostic Tests. See "Diagnostic Tests" on page 2-19.
1. Power off.
Make sure the unit’s power is off.
2. Enter Diagnostic Mode.
Press softkeys 4 and 6 at the same time, and hold them down while turn­ing the power on. See Figure 2-1 for softkey numbering.
3. Wait for the unit to initialize.
This may take several seconds. The unit is ready to proceed when the screen cursor responds to softkey inputs.
4. Select the desired test or function.
To select a test, press the and softkeys to move up or down the list until the desir ed te st is h ighli ghted. Then p ress the softkey to
start that test.
ENTER
5. Exit Diagnostic Mode.
To exit Diagnostic Mode, turn the unit off.
M4735A Service Manual 2-11

The Software Su pport Tool

The Software Support Tool
The Software Support Tool (M4735-87890) allows field service personnel to perform 2 tasks: 1) to enable the SpO
number. These tasks need to be performed under the following circum­stances:
l
The Control PCA has been replaced. The Control PCA contains all the operating software, configured
for the installed hardware. It also contains the unit’s serial numbe r, which was programmed in during manufacturing.
The new Control PCA must be programmed to recognize the hardware installed in this unit, and to contain that unit’s serial number.
l
The unit has received an upgrade adding the SpO2 capability. The added hardware will not be automatically recognized. The
Control PCA must be programmed to recognize the new hardware installed.
option, and 2) to program in the serial
2

Using the Support Tool

1. Prepare the unit.
a. Have unit power off, and have either a fresh battery installed or the
AC power cord plugged in.
b. Insert the Support Tool data card into the unit. c. Turn unit power on.
2. Follow the screen prompts.
a. Select whether SpO b. Program in the unit’s serial number.
l
If this is an Sp O2 upgrade, the serial number should already be present. In this case, verify it against the factory-applied label on
the bottom of the case.
l
If this is a Control PCA replacement, program in the serial num­ber found on the factory-applied label on the bottom of the case using the softkeys as i nstructe d on the screen. Be sure to program it in accurately, as the serial number is used for all repair history tracking.
hardware is installed or not as appropriate.
2
c. Check all the displayed information carefully before proceeding.
l
If the displayed information is correct, follow the screen prompts to save the configuration.
2-12 Performance Verification and Safety Tests
The Software Support Tool
l
If any of the information is incorrect, follow the prompts to NOT save the configuration, then start over by powering the unit off, then back on.
3. Turn off the power and remove the Data Card.
4. Check the customer configuration.
a. Turn the unit back on and enter Configuration Mode (see "Configura-
tion Mode" on page 2-10).
b. Print the configuration and check it against the printout from before
the servici ng began. Reset the configuration (or load it from a Data Card) as needed.
5. Verify performance.
Perform Performance Verification Testing as described in "Performance Verification and Safety Tests" starting on page 2-1.
2
M4735A Service Manual 2-13

Performance Verification

Performance Verificatio n
This section gives instructions for running Performance Verification tests on the M4735A. The tests are seque nced to check more basic fu nctions fi rst, and then build on that to check more complex functions. We recommend you perform these tests in this sequence. If desired, you can make copies of the Test Results Matrix (page 2-4) and use it to record results.
The Performance Verification tests include:
Section Page
Visual Inspection 2-15 Functional Checks 2-16 Diagnostic Tes ts 2-19 Safety Tests 2-39 Battery Capacity Test 2-40
2-14 Performance Verification and Safety Tests
Performance Verification

Visual Inspection

1. Inspect the unit.
Inspect the entire unit, especially paddles, power cord, printer, battery, cables, and sensors for signs of the following.
l
Wear or damage to paddles, cables, and adapters.
l
Wear or damage to patient cables and associated strain reliefs.
l
Mechanical damage to case, membrane switches, speaker cover, ambient light sensor cover, display window.
l
Loose or missing hardware.
l
Evidence of liquid spill. Check inside the printer bucket and clean out any ac cumulation using glove s and an appr oved c leaner.
l
Residue on the therm al printhead.
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Printer roller wear.
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Wear or damage to power cord and associated strain relief.
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Corrosion on connector pins, printer parts, or battery contacts.
2
Pass: Only normal wear, no damage serious enough to inhibit performance. No corrosion visible.
2. Check the consumables.
Check the ECG electrodes and defibrillator pads for freshness (data code or expiration date) and condition.
Pass: Electrodes and pads are within their expiration date and appear usable. Packaging is unopened and shows no tears or punctures. No corrosion visible on connector sockets, electrodes, or pads.
M4735A Service Manual 2-15
Performance Verification

Functional Checks

The following functional checks exercise the basic functions of the defibrilla-
tor/monitor. They are intended as a broad check of the unit’s performance, and are designed to complement (not replace) the Diagnostic Tests described later.
If all elements of a test pass, record that test as a P A SS and re tu rn to the main diagnostic menu by pressing . If there is any failure, begin trouble-
shooting and repairing as needed. See "Troubleshooting" on page 3-1. The Functional Checks include:
Check Page
ECG Functional Checks 2-16 Shock Advisory Functional Check 2-17
MAIN
Synchronized Cardiovers ion Funct ional Check
Sp02 Functional Check 2-18
2-18
ECG Functional Checks
This section describes how to check the oper ation of the ECG func tions. Each of the ECG checks assumes the unit and the simulator are still set up as they were at the end of the previous ECG check.
To check ECG display and Heart Rate (HR) functions:
1. Set up the simulator.
a. Connect the ECG simulator to both the Pads input and the 3- or
5-lead ECG cable.
b. Set the simula tor for normal sinus rhythm (NSR), 1mV amp litude, at
some nominal rate (e.g., 60 bpm).
2. Set up the M4735A.
Set the M4735A to Manual operating mode (not Diagnostic Mode).
3. Check the displayed ECG.
Using the softkey, verify that the display shows a normal ECG with a clean baseline for both Pads and Lead II.
LEAD SELECT
4. Check the Heart Rate (HR).
Verify that the Heart Rate (HR) displayed is correct.
5. Check Leads Off.
a. Disconnect the ECG simulator from the pads cable and ver ify that the
display shows a das hed li ne in pla ce of the wavefo rm and t hat the u nit both alarms and gives the Pads Off message
b. If using a 5-lead ECG cabl e, set the unit to monitor from th e V lead.
2-16 Performance Verification and Safety Tests
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