Philips HeartStart XL Service manual (2)
HEARTSTART XL
Service Manual
M4735A
Service Manual
M4735A HeartStart XL
Defibrillator/Monitor
Notice
About This Edition
Edition 2
Printed in the USA
Publication number M4735-90900
The information in this manual applies
to the M4735A HeartStart XL Release
Main 15 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, October 1, 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
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 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 M4735A Defibrillator/Monitor
complies with the requirements of the
Medical Device Directive 93/42/EEC
and carries the
ingly.
Authorized EU-representative:
Philips Medizinsysteme Böblingen
GmbH
Hewlett Packard Str. 2
71034 Böbingen
Germany
Canada EMC:ICES-001
mark accord-
0123
ii
Conventions
This manual uses the following text conventions:
Printed and On-Line
WARNING W arning statements describe conditions or actions that can result in personal injury
or loss of life.
CAUTION Caution statements describe conditions or actions that can result in damage to
the equipment or loss of data.
NO TE Notes contain additional information on servicing this product.
TIP:
Tips provide hands-on insight into servicing this product.
Tex t represents messages that appear on the display
Softkey
represents softkey labels that appear on the display
above or below the button to which they correspond
On-Line Only
Hypertext
represents hypertext links, which will display as blue;
click on the link to go to that destination, then click on
the destination to return.
iii
Contents
Text Conventions
Printed and On-Line .....................................................................................................iii
On-Line Only ...............................................................................................................iii
Hypertext ...........................................................................................................................iii
Introduction
Overview ....................................................................................................................1-1
Web-Based Training ....................................................................................................... 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
Required Testing Levels .............................................................................................2-2
External Repairs/No Trouble Found ............................................................................... 2-2
Printer .............................................................................................................................. 2-3
Internal Repairs ...............................................................................................................2-3
Test and Inspection Matrix .........................................................................................2-4
Test Equipment ....................................................................................................... ..2-10
Configuration and Diagnostic Modes ......................................................................2-11
Configuration Mode ...................................................................................................... 2-11
Diagnostic Mode ........................................................................................................... 2-12
The Language Support Tool .....................................................................................2-13
Using the Language Support Tool ................................................................................ 2-13
Performance Verification Tests ................................................................................2-15
Visual Inspection ........................................................................................................... 2-16
Functional Checks ......................................................................................................... 2-18
Diagnostic Tests ............................................................................................................ 2-22
Safety Tests ...................................................................................................................2-43
Battery Capacity Test .................................................................................................... 2-47
v
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
Evaluate ......................................................................................................................3-3
Troubleshoot ...............................................................................................................3-5
System Errors ..................................................................................................................3-5
Repair .........................................................................................................................3-6
Check the repair .............................................................................................................. 3-6
Verify ..........................................................................................................................3-7
Troubleshooting Tables ..............................................................................................3-8
Using the Tables ............................................................................................................. 3-8
General Problems .......................................................................................................3-9
Unit Unresponsive ...........................................................................................................3-9
Error Codes ................................................................................................................... 3-10
System Messages .......................................................................................................... 3-12
Momentary Messages ................................................................................................... 3-15
Audio Tones ................................................................................................................ 3-17
Extended Self Test Failures .......................................................................................... 3-18
Operational Problems ...............................................................................................3-19
ECG Monitoring ......................................................................................................... 3-19
SpO2 Monitoring ..........................................................................................................3-22
Defibrillation and Cardioversion .................................................................................. 3-23
Pacing ............................................................................................................................3-25
Printer ............................................................................................................................ 3-26
Display .......................................................................................................................... 3-27
Audio ............................................................................................................................ 3-28
Controls ......................................................................................................................... 3-29
Battery and Charging Circuits ......................................................................................3-30
Data Card ......................................................................................................................3-31
Calling for Service ...................................................................................................3-32
United States of America .............................................................................................. 3-32
Latin America ............................................................................................................... 3-32
Canada .......................................................................................................................... 3-32
Other International Areas .............................................................................................. 3-33
Equipment Information ................................................................................................. 3-34
vi
Contents
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
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 .................................................................................. 4-23
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
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
vii
Contents
Internal Assemblies - Bottom Case ..........................................................................4-79
Battery PCA .................................................................................................................. 4-80
Defibrillator Capacitor .................................................................................................. 4-84
Power PCA .................................................................................................................... 4-86
Power Supply ................................................................................................................ 4-90
Patient Connector .......................................................................................................... 4-94
Replacement Bottom Case ............................................................................................4-97
Closing the Case .......................................................................................................4-99
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
Latin America ................................................................................................................. 5-3
Canada ............................................................................................................................ 5-3
Other International Areas ................................................................................................ 5-4
Special Tools ..............................................................................................................5-5
M4735A Unit Exchange Program ..............................................................................5-6
Replacement Parts Tables ...........................................................................................5-7
Electrical Assemblies .................................................................................................5-8
Control PCA ................................................................................................................... 5-8
Other Replacement PCAs ............................................................................................. 5-10
Other Electrical Assemblies .......................................................................................... 5-10
Individual Electrical Parts ............................................................................................. 5-11
Mechanical Assemblies ............................................................................................5-12
Bezel Assembly ............................................................................................................ 5-12
Pacer Keypad Assembly ...............................................................................................5-13
Other Mechanical Assemblies ...................................................................................... 5-14
Connector Assemblies .................................................................................................. 5-14
Individual Mechanical Parts ..........................................................................................5-15
Labels .......................................................................................................................5-16
Instruction Label Sets ................................................................................................... 5-16
Case Label Sets ............................................................................................................. 5-18
Paddle Labels ................................................................................................................ 5-20
Other Labels .................................................................................................................. 5-20
Supplies & Accessories ............................................................................................5-21
Key Components ......................................................................................................5-25
viii
Contents
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
Power Supply .................................................................................................................. 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
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 ................................................................................................ 6-16
Data Card ......................................................................................................................6-16
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
ix
Contents
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
Waveforms - 200J .................................................................................................7-11
Waveforms - 200J (continued) .................................................................................7-12
Waveforms - 200J (continued) ............................................................................7-13
Symbol Definitions ..................................................................................................7-14
Safety Considerations ...............................................................................................7-16
Electromagnetic Compatibility ................................................................................7-19
Reducing Electromagnetic Interference ........................................................................ 7-19
Restrictions for Use ...................................................................................................... 7-20
Immunity Level ............................................................................................................. 7-20
x
1Introduction
This Service Manual provides the information needed to successfully service the
M4735A HeartStart XL Defibrillator/Monitor. The intended users of this manual 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
Instructions for Use (M4735-91900) 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.
Web-Based Training
Web-based service training for the M4735A HeartStart XL
Defibrillator/Monitor is available. You can access the training through the
Biomed On-Line web site at http://bol.medical.philips.com.
Defibrillator/Monitor
1
The M4735A is a biphasic, semi-automated external defibrillator. This
portable, lightweight device offers two modes of operation for defibrillation:
z Semi-Automatic External Defibrillation (AED) Mode
z Manual Mode
In AED Mode, the M4735A analyzes the patient’s ECG and advises the
clinician whether or not to deliver a shock. Defibrillation is performed
through multifunction defib electrode pads.
In Manual Mode, the M4735A 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.
Defibrillation is performed either through multifunction defib electrode pads
or through paddles.
Manual Mode also allows the clinician to perform synchronized cardioversion
and offers optional noninvasive pacing (using a monophasic waveform).
ECG monitoring can be accomplished in either mode using one of 3 methods:
z ECG from the defib pads.
z 3-lead ECG using separate monitoring electrodes.
z Optional 5-lead ECG using separate monitoring electrodes.
1-1
Overview
Optional pulse oximetry (SpO2) monitoring is available in both modes, as
well.
The M4735A automatically stores critical events, such as shocks and alarm
violations, in its internal memory. An Event Summary may be printed at any
time. The M4735A also enables you to store data and events on an optional
M3510A Data Card for downloading to the Event Review 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. For more
details see the “Battery Maintenance” section in the Instructions for Use, and
the Battery Maintenance Application Note.
NO TE The defibrillator will take longer to charge when powered by AC without a
battery installed. To ensure optimal performance, always have a fully charged
battery in the defibrillator, even when using AC power.
Installation
The M4735A does not require installation. The Instructions for Use describes
the setup required before placing the device into service, as well as configuration options.
Upgrades
Upgrades are available to add specific functionality to units in the field.
These upgrades are:
z M4738A Pacing Upgrade (adds pacing).
z M4739A SpO
upgrade. (adds SpO2).
2
Consult your sales representative or dealer or distributor for the latest details.
Preventive Maintenance
Preventive maintenance and periodic operational checks are intended to be
performed by the user. Both topics are covered in the Maintenance chapter of
the Instructions for Use.
1-2 Introduction
Overview
Repair Philosophy
Defibrillator/Monitor
The repair philosophy of the M4735A is subassembly replacement. Examples
of subassemblies are the printer, the Control Printed Circuit Assembly (PCA),
and selected connectors and other items. Repairs that involve replacing components on a PCA are not supported.
CAUTION Individual component replacement should not be attempted outside of a fac-
tory authorized repair facility. Component level repair is extremely difficult
due to the extensive use of surface mount technology and the high parts-density on the circuit boards. Unauthorized component replacement can impair
performance of the M4735A.
Batteries
The repair philosophy for the SLA battery (M3516A) is unit replacement. If a
battery fails, it is replaced, not repaired.
For information on ordering replacements, see "Supplies & Accessories" on
page 5-21.
1
M4735A Service Manual 1-3
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 chapter are as follows:
Section Page
Required Testing Levels 2-2
Test and Inspection Matrix 2-4
Test Equipment 2-10
Configuration and Diagnostic Modes 2-11
The Language Support Tool 2-13
Performance Verification Tests 2-15
2
2-1
Required Testing Levels
Required Testing Levels
The Performance Verification Tests in this chapter are intended to verify
proper operation of the M4735A following repair. The level of testing
required corresponds to the type of repair performed, and is divided into 3
categories:
z External Repairs/No Trouble Found.
z Printer Replacement.
z Internal Repairs.
External Repairs/No Trouble Found
External Repairs are those involving the repair or replacement of one or
more of the items below. No Trouble Found applies when no malfunction
can be found, or when the problem appears to be due to improper use. In
either situation, the key point is that the case has not been opened.
z External paddles
z Internal paddles and/or adapter cable
z Paddle holders
z Pads adapter cable
z ECG cable
z SpO
z Battery
z Labels
z AC Power cord
z Consumables (ECG monitoring electrodes, multifunction defibrilla-
cable or sensor
2
tion pads, printer paper)
z Main fuse (on Battery PCA)
z Data Card Door Assembly
z Battery Eject Assembly
The following testing is required after an External Repair or when the
outcome of the service is No Trouble Found (when the case has not been
opened):
z Perform the Visual Inspection (page 2-16).
z Run the Extended Self Test (page 2-25).
z Print and Verify the System Log (page 2-23).
2-2 Performance Verification and Safety Tests
Required Testing Levels
Printer
If the printer was replaced, and the case was not opened, the following tests
are required:
z Perform the Visual Inspection (page 2-16).
z Run the Extended Self Test (page 2-25).
z Run the Printer Test (page 2-30).
z Print and Verify the System Log (page 2-23).
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 2-16.
2
M4735A Service Manual 2-3
Test and Inspection Matrix
Test and Inspection Matrix
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)
Test or Inspection to
Perform
Inspect the unit, accessories, cables, etc.for signs
of wear, damage, corrosion, or missing items, as
described on page 2-16.
In normal Operating Mode,
perform the following functional checks:
• ECG (page 2-18). • Waveform clear on dis-
• Shock Advisory (page 2-
19).
• Synchronized Cardiover-
sion (page 2-20).
• SpO
(page 2-21). • 95% -100%
2
Expected Test Results
If no unusual damage, no
corrosion, no missing items:
x=p.
then Visual Inspection
passes
If all functions respond as
expected: x=p
play; HR correct on display;
HR alarm works. Leads off,
pads off indicators as
expected.
• Shock Advised only when
appropriate
• Shock delivered with cor-
rect timing (<
60msec)
Data to Record
x = p (pass) or f(fail)
V:x
Example V:p
F:x
Example F:p
then Functional Check
passes
Extended Self
Test (X)
In Diagnostic Mode, run
the Extended Self Test
(page 2-25). Includes Data
Card T est and time/date
check.
If “Pass” reported on all tests
applicable to the device configuration and options: x=p.
then Extended Self test
passes
X:x
Example X:p
2-4 Performance Verification and Safety Tests
Table 2-1 Performance Verification and Safety Tests (Continued)
Test and Inspection Matrix
Test Group Name
User Interface
Tests (U)
ECG Tests (E) In Diagnostic Mode, run
Test or Inspection to
Perform
• In Diagnostic Mode, run
the following tests (page
2-28):
• Controls Test • All keys respond as
• Display Test • Visual Pass assessment by
• Audio Test • Alerts, alarms, and tones
• Printer Test • Print quality is adequate;
the ECG Tests (page 2-33):
• Status messages (lead,
pad, DSP)
Expected Test Results
If all data within limits, all
checks pass: x=p
expected
service personnel
are clearly heard
no stray marks or lines.
• Print speed: 25 mm
(1.25mm)
then User Interface test
passes
If all data within limits, all
checks pass: x=p
• “Good” displayed for all
three status messages
± 5%
Data to Record
x = p (pass) or f(fail)
U:x
Example: U:p
2
E: x
Example: E:p
• DC offset • Ignore DC Offset - used
only in factory manufacturing.
Amplifier gain
• Pads Peak to Peak (Moni-
tor)
• Leads Peak to Peak (Diag-
nostic)
Amplifier noise
• Leads Peak to Peak (Diag-
nostic) - cc
• Pads Peak to Peak (Moni-
tor) - dd
PCI measurement
• PCI - Paddles in Pockets • 50 ± 30 Ω
• PCI - Paddles open • >
• 1000uV
• 1000uV
• 0
• 0
then ECG Test passes
±10%
±10%
± 30uV
± 30uV
1250 Ω
M4735A Service Manual 2-5
Test and Inspection Matrix
Table 2-1 Performance Verification and Safety Tests (Continued)
Test Group Name
Pacing Test (P) In Diagnostic Mode, run
Defibrillator Test AC Power (DA)
(if AC Power used
in normal operation)
Test or Inspection to
Perform
the Pacing Test (page 2-
38):
• (70 ppm) 30 mA • 30 mA ± 5 mA
• (180 ppm) 200mA • 200mA± 20 mA
Using only AC power,
enter Diagnostic Mode
and run the Defibrillator
Test (AC Power at
200Joules) (page 2-40):
Measured by
Defibrillator Analyzer:
• Delivered energy
Displayed by
M4735A:
• Available Energy after
Shock
• Msec to charge • <
Expected Test Results
All data within limits, all
checks pass: x=p
All data within limits, all
checks pass: x=p. If the
measurements are as follows:
± 30J
• 200
• 0
15000 msec
Data to Record
x = p (pass) or f(fail)
P:x
Example: P:p
DA:x
Example: DA:p
• Delivered energy • Actual delivered energy
±7%
• Impedance • 42 to 57 Ω
• Defib errors • None (0)
then the Defibrillator test
(AC Power) passes
2-6 Performance Verification and Safety Tests
Table 2-1 Performance Verification and Safety Tests (Continued)
Test and Inspection Matrix
Test Group Name
Defibrillator Test Battery Power
(DB)
Test or Inspection to
Perform
Using only battery power,
enter Diagnostic Mode
and run the Defibrillator
Test (at 200Joules) (page
2-41).
Measured by
Defibrillator Analyzer
• Delivered energy • 200 ± 30 J
Displayed by
M4735A
• Available Energy after
Shock
• Msec to charge • <
• Delivered energy • Actual delivered energy
Expected Test Results
All data within limits, all
checks pass: x=p
If the measurements are:
• 0
3000 msec
±7%
• Impedance • 42 to 57 Ω
• Defib errors • None (0)
Data to Record
x = p (pass) or f(fail)
DB:x
Example: DB:p
2
Defibrillator
Disarm Test (D)
Enter Diagnostic Mode
and run the Defibrillator
Disarm Test (page 2-42)
then the Defibrillator test
(Battery Power) passes
All readings as expected:
x=p. No errors reported.
then the Defibrillator Disarm
test passes
D:x
Example: D:p
M4735A Service Manual 2-7
Test and Inspection Matrix
Table 2-1 Performance Verification and Safety Tests (Continued)
Test Group Name
Test or Inspection to
Perform
Safety Tests Indicate test results as
follows:
Earth Leakage
Current (S1)
Earth Leakage Current
NC (Normal Condition) - aaa
Earth Leakage Current
SF (Single Fault -open neutral) - bbbb
Patient Lead
ECG Patient Cable If readings are as expected: S3:P/aa/bb/cc/dd/ee/ff/ggg/
Leakage (S3)
Expected Test Results
Note: All leakage current
tests include both Normal
and Reverse Polarity Conditions.
Report worst case values.
All values within limits: x=p
If Normal Condition Maximum leakage current
• < 300 uA (UL, 120 VAC)
500 uA (IEC, 240 VAC)
• <
If Single Fault Maximum
leakage current
1000 uA
• <
then Earth Leakage Safety
test passes
Data to Record
x = p (pass) or f(fail)
S1:P/aaa/bbbb
Example:
S1:P/125/800
hhh/iii/jj/kk/lll
Example:
S3:P/9/49/49/10/50/50/100/
499/4750/9/49/83
• Source
(Normal Condition) - aa
• Source (Single Fault
condition - open earth,
open neutral) - bb
• With Mains on applied part
(Single Fault condition) - cc
SPO
2
• Source
(Normal Condition) - dd
• Source (Single Fault
Condition - open earth,
open neutral) - ee
• With Mains on applied part
(Single Fault condition) - ff
< 10 uA
<
50 uA
<
50 uA
then Patient Lead Leakage
Safety test passes
If readings are as expected:
<
10 uA
<
50 uA
50 uA
<
then Patient SPO
Leakage
2
Safety test passes
2-8 Performance Verification and Safety Tests
Table 2-1 Performance Verification and Safety Tests (Continued)
Test and Inspection Matrix
Test Group Name
Test or Inspection to
Perform
External Paddles/Pads If readings are as expected:
• Source
(Normal Condition) - ggg
• Source (Single Fault
Condition) - hhh
• With Mains on applied part
(Single Fault Condition) - iii
Internal Paddles If readings are as expected:
• Source
(Normal Condition) - jj
• Source
(Single Fault Condition) kk
• With Mains on applied part
(Single Fault Condition) - lll
Expected Test Results
<
100 uA
<
500 uA
<
5000 uA
then External Paddles/Pads
Safety test passes
<
10 uA
<
50 uA
<
100 uA
then Internal Paddles/Pads
Safety test passes
Data to Record
x = p (pass) or f(fail)
2
Note: When recording test results, separate results within a test by slashes; separate tests by a semicolon (;); and
use no empty spaces. For example:
V:x;F:x;X:x;U:x;E:x;P:x;
DA:x;DB:x;D:x;
S1:P/aaa/bbbb;S3:P/aa/bb/cc/dd/ee/ff/ggg/hhh/iii/jj/kk/lll
V:p;F:p;X:p;U:p;E:p;P:p;
DA:p;DB:p;D:p;
S1:P/125/800; S3:P/9/49/49/10/50/50/100/499/4750/9/49/83
M4735A Service Manual 2-9
Test Equipment
Test Equipment
Table 2-2 lists the equipment needed to perform the Performance Verification
tests, and provides specifications for commercially available analyzers and
simulators. Test equipment is called out within each test procedure when
needed. In addition, A 50 ohm test load is available (M1781A or M3725A).
Table 2-2 Equipment List
Equipment/Test Specifications
ECG Simulator
Calibrated Leads
• Amplitude accuracy ±2%
• Rate accuracy ±2%
Calibrated Paddles
• Amplitude accuracy ±2%
• Rate accuracy ±2%
Defibrillator Analyzer
Waveform compatibility Meets all specs below using biphasic
Load resistance: 50 Ω ±1% (non-inductive)
Maximum energy: ≥ 200 joules
Maximum voltage: ≥ 2500 V
Maximum current: ≥50 A
Measurement accuracy:
• ≥ 20 joules: ≤ ±2% of reading
• < 20 joules: ≤ ±0.4 joules
ECG simulator
ECG simulator
truncated exponential waveform.
Cardioversion measurement range: –150 to +150 ms
Pacer tester
Load impedance: ≤400 Ω
Current
measurement accuracy
• 10 mA–50 mA: <±2 mA
• 50 mA–200 mA: <±4%
Rate
measurement accuracy
• 30–180 ppm: <±0.5%
Waveform duration accuracy:
• 30–180 ppm: ±1ms
2-10 Performance Verification and Safety Tests
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
Instructions for Use for details on configuration settings and what effect they
have.
CAUTION Inserting or removing the Data Card while the unit is on can corrupt the Data
Card and prevent the unit from powering on again. If this occurs, see Chapter
3, Troubleshooting.
1. Power off.
Make sure the unit’s power is off.
2. Insert a Data Card (if applicable).
If you intend to save the configuration to a Data Card (or load the
configuration from a Data Card), insert the Data Card now. To avoid
possible confusion, designate one Data Card as the “Configuration Card”
and label it clearly. Keep this card physically separate from cards used by
the clinical staff for data storage.
3. Enter Configuration Mode.
Press softkeys 4 and 5 at the same time, and hold them down while
turning the power on. See Figure 2-1 for softkey numbering.
4. Select and manage Configuration choices.
z To select a configuration, press the and softkeys to move up
or down the list until the desired Settings item is highlighted. Then
press the softkey to access those settings.
ENTER
2
z To print out a strip with all the current configuration choices, select
Print All Settings and press .
z To store the configuration settings on a Data Card, select Save Set-
tings to Data Card and press . When prompted with Save Settings to Data Card? press .
z To load configuration settings from a Data Card, select Load Settings
from Data Card and press . When prompted with Load Settings
from Data Card? press .
M4735A Service Manual 2-11
ENTER
ENTER
SAVE
ENTER
LOAD
Configuration and Diagnostic Modes
5. Exit Configuration Mode.
Figure 2-1 Softkey Numbers
z To exit Configuration Mode, turn the unit off.
z Wait 2 seconds. Remove the Data Card by pressing the black eject
button and pulling the Data Card from the compartment.
4567
123
Diagnostic Mode
These instructions describe how to enter Diagnostic Mode. Once in
Diagnostic Mode, you can do the following:
z Print the System Log. See "System Log" on page 2-23.
z Run the Extended Self Test. See "Extended Self Test" on page 2-25.
z Run other Diagnostic Tests. See "Diagnostic Tests" on page 2-22.
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 Energy Select Switch to Manual 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.
2-12 Performance Verification and Safety Tests
The Language Support Tool
4. Select the desired test or function.
To select a test, press the and softkeys to move up or down the
list until the desired test is highlighted. Then press the softkey to
ENTER
start that test.
5. Exit Diagnostic Mode.
To exit Diagnostic Mode, turn the unit off.
The Language Support Tool
The Language Support Tool allows field service personnel to perform several
tasks:1) to set the language of the Control PCA of the defibrillator; 2) to
enable the SpO
to be performed under the following circumstances:
z 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 number,
which was assigned and programmed during manufacturing.
The new Control PCA must be programmed to recognize the
hardware installed in this unit, to contain that unit’s
serial number, and to set the language of the unit.
z The unit has received an upgrade adding the SpO
The added hardware will not be automatically recognized. The
Control PCA must be programmed to recognize the new hardware
installed.
z The unit’s software is being updated.
Software upgrades are periodically released to resolve customer
issues. The Language Support tool enables you to load new software
onto the unit.
option; 3) to program in the serial number. These tasks need
2
capability.
2
2
Using the Language Support Tool
1. Save the configuration to a Data Card.
a. Make sure the unit is powered off, and have either a fresh battery
installed or the AC power cord plugged in.
b. Follow the instructions in "Configuration Mode" on page 2-11 to save
the configuration to a Data Card.
M4735A Service Manual 2-13
The Language Support Tool
2. Activate the Language Support Tool
a. Insert the Language Support Tool data card into the unit.
b. Press softkey 7 and Mark at the same time, and hold them down while
turning the Energy Select Switch to Manual On. (See Figure 2-1 for
softkey numbering.)
3. Follow the screen prompts.
a. Press YES to continue.
The message "Upgrade software found Proceed to Program?" is displayed.
b. Press Yes to set the unit’s language. Do not press any keys or touch
the unit until the process is complete.
c. Select whether SpO
d. Program in the unit’s serial number.
z If this is an SpO
hardware is installed or not as appropriate.
2
upgrade, the serial number should already be
2
present. In this case, verify it against the factory-applied label on
the bottom of the case.
z If this is a Control PCA replacement, program in the serial num-
ber found on the factory-applied label on the bottom of the case
using the softkeys as instructed on the screen. Be sure to program
it in accurately, as the serial number is used for all repair history
tracking.
e. Check all the displayed information carefully before proceeding.
z If the displayed information is correct, follow the screen prompts
to save the configuration.
z 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.
4. Turn off the power. Wait 2 seconds. Remove the Data Card by press-
ing the black eject button and pulling the card from the compartment.
5. Check the customer configuration.
a. Turn the unit back on and enter Configuration Mode (see
"Configuration Mode" on page 2-11).
b. Print the configuration and check it against the printout from before
the servicing began. Reset the configuration (or load it from a Data
Card) as needed.
6. Verify performance.
Perform Performance Verification Testing as described in "Performance
Verification and Safety Tests" starting on page 2-1.
2-14 Performance Verification and Safety Tests
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