Philips HeartStart XL Service manual
HEARTSTART XL
Service Manual
M4735A
Service Manual
M4735A HeartStart XL
Defibrillator/Monitor
Notice
About This Edition
Edition 5
Printed in the USA
Publication number M4735-90900
The information in this manual applies
to the M4735A HeartStart XL Release
Main 20 and earlier This information is
subject to change without notice.
Philips 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
Edition 3, October 2004
Edition 4, July, 2005
Edition 5, April, 2006
Copyright
Copyright © 2006
Koninklijke Philips Electronics N.V
All rights are reserved. Reproduction in
whole or in part is prohibited without
the prior written consent of the copyright holder.
Use of supplies or accessories other
than those recommended by Philips
Medical Systems may compromise
product performance.
Warning
Radio Frequency (RF) interference
from nearby transmitting devices may
seriously degrade performance of the
M4735A HeartStart XL Defibrillator/
Monitor. Electromagnetic
compatibility with surrounding devices
should be assessed prior to using the
defibrillator.
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.
Manufacturer
Philips Medical Systems
3000 Minuteman Road
Andover, MA USA 01810-1099
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 Medizin Systeme Böblingen
GmbH
Hewlett Packard Str. 2
71034 Böbingen
Germany
Canada EMC:ICES-001
For the Declaration of Conformity
Statement, please see the Philips
Medical web site at
http://incenter.medical.philips.com/
PMSPublic. Scroll over the Quality and
Regulatory Tab located in the upper left
corner of the window. Click to select
Regulatory by Modality. Then click to
select Defibrillators and select the entry
for Declaration of Conformity (DoC)
mark accord-
0123
.
China:
After sales service: Beijing MEHECOPHILIPS Medical Equipment Service
Center
After sales service address: No. 208,
2nd District, Wang Jing Li Ze Zhong
Yuan, Chao Yang District, Beijing
Postal Code: 100102
Telephone: 010-64392415
Registration Number:
SFDA(I)20043212740
Product standard number:
YZB/USA 2764-21
ii
This manual uses the following text conventions:
Printed and On-Line
WAR NIN G Warning 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.
NOTE Notes contain additional information on servicing this product.
TIP:
Tips provide hands-on insight into servicing this product.
Te x 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
Introduction
Who Should Use this Manual ....................................................................................1-1
Overview ....................................................................................................................1-1
Web-Based Training ....................................................................................................... 1-1
Defibrillator/Monitor ...................................................................................................... 1-2
Batteries .......................................................................................................................... 1-2
Installation ...................................................................................................................... 1-3
Upgrades ......................................................................................................................... 1-3
Preventive Maintenance .................................................................................................. 1-3
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 ....................................................................................................... ....2-9
Configuration and Diagnostic Modes ......................................................................2-10
Configuration Mode ...................................................................................................... 2-10
Diagnostic Mode ........................................................................................................... 2-11
The Language Support Tool .....................................................................................2-12
Using the Language Support Tool ................................................................................ 2-12
Performance Verification Tests ................................................................................2-14
Visual Inspection ........................................................................................................... 2-15
Functional Checks ......................................................................................................... 2-17
Diagnostic Tests ............................................................................................................ 2-21
Safety Tests ..................................................................................................................2-42
Battery Capacity Test .................................................................................................... 2-46
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
v
Contents
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 ................................................................................................................... 3-11
System Messages .......................................................................................................... 3-13
Momentary Messages ................................................................................................... 3-16
Audio Tones ................................................................................................................ 3-18
Extended Self Test Failures .......................................................................................... 3-19
Operational Problems ...............................................................................................3-20
ECG Monitoring ......................................................................................................... 3-20
SpO2 Monitoring .........................................................................................................3-23
Defibrillation and Cardioversion ................................................................................. 3-24
Pacing ............................................................................................................................3-26
Printer ........................................................................................................................... 3-27
Display .......................................................................................................................... 3-28
Audio ............................................................................................................................ 3-29
Controls ......................................................................................................................... 3-30
Battery and Charging Circuits ......................................................................................3-31
Data Card ......................................................................................................................3-32
Calling for Service ...................................................................................................3-33
North America .............................................................................................................. 3-33
Latin America ............................................................................................................... 3-33
Europe ........................................................................................................................... 3-33
Asia/Asia Pacific ........................................................................................................... 3-34
Equipment Information ................................................................................................. 3-35
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 .......................................................................................................................... 4-4
External Assemblies ...................................................................................................4-5
User Replaceable Parts and Accessories ......................................................................... 4-6
User Maintenance ........................................................................................................... 4-6
Printer Assembly ............................................................................................................. 4-7
Battery Cover ................................................................................................................ 4-11
Main Fuse ..................................................................................................................... 4-13
vi
Contents
Battery Eject Assembly ................................................................................................ 4-15
Data Card Door ............................................................................................................. 4-17
Energy Select Knob .................................................................................................... 4-19
Paddle Holders .............................................................................................................. 4-20
Labels ............................................................................................................................ 4-22
Label Descriptions ........................................................................................................ 4-22
Removing and Replacing Labels .................................................................................. 4-25
Opening the Case .....................................................................................................4-26
Discharge the Power Supply Capacitors ...................................................................... 4-26
Separate the Case ........................................................................................................ 4-28
Discharge the Defibrillator Capacitor .......................................................................... 4-32
Identifying Internal Subassemblies ............................................................................... 4-34
Internal Assemblies - Top Case ................................................................................4-35
Lithium Backup Battery ................................................................................................ 4-36
Control PCA ................................................................................................................ 4-38
Shield Plate ...................................................................................................................4-42
Keyscan PCA (EL Display) .......................................................................................... 4-44
Keyscan PCA (LCD Display) ....................................................................................... 4-52
Bezel Assembly .......................................................................................................... 4-59
Energy Select Switch .................................................................................................... 4-63
Display Assembly (EL Display) ................................................................................... 4-65
Display Assembly (LCD Display) ................................................................................ 4-68
Hooded Plastic Shield ................................................................................................... 4-71
Parameter PCA .............................................................................................................. 4-72
SpO2 PCA .................................................................................................................. 4-78
ECG Connector ............................................................................................................. 4-81
SpO2 Connector ............................................................................................................ 4-84
Speaker ....................................................................................................................... 4-86
AC Mains Connector ....................................................................................................4-88
ECG Out (Sync) Connector .......................................................................................... 4-91
Pacer Keypad ................................................................................................................4-92
Replacement Top Case ..................................................................................................4-97
Internal Assemblies - Bottom Case ........................................................................4-101
Battery PCA ................................................................................................................ 4-102
Defibrillator Capacitor ................................................................................................ 4-106
Power PCA .................................................................................................................. 4-108
Power Supply .............................................................................................................. 4-112
Patient Connector ........................................................................................................ 4-118
Replacement Bottom Case ..........................................................................................4-121
Closing the Case .....................................................................................................4-123
Replacement Parts
Overview ....................................................................................................................5-1
Chapter Contents ............................................................................................................. 5-1
Ordering Replacement Parts ..........................................................................................5-1
vii
Contents
Ordering Supplies and Accessories ................................................................................ 5-1
Key Components ........................................................................................................... 5-2
Special Tools ..............................................................................................................5-3
M4735A Unit Exchange Program ..............................................................................5-4
Replacement Parts Tables ...........................................................................................5-5
Electrical Assemblies .................................................................................................5-6
Control PCA ................................................................................................................... 5-6
Other Replacement PCAs ............................................................................................... 5-7
Other Electrical Assemblies ........................................................................................... 5-7
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
Paddle Labels ................................................................................................................ 5-18
Other Labels ................................................................................................................. 5-18
Supplies & Accessories ............................................................................................5-19
Key Components ......................................................................................................5-23
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
viii
Contents
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 (EL) ...................................................................................................................7-4
Display (LCD) ................................................................................................................ 7-4
Battery ............................................................................................................................. 7-5
Thermal Array Printer ..................................................................................................... 7-5
Noninvasive Pacing ........................................................................................................ 7-6
SpO2 Pulse Oximetry ..................................................................................................... 7-6
Event Storage ..................................................................................................................7-7
General ............................................................................................................................ 7-7
Environmental ................................................................................................................. 7-8
Waveforms .................................................................................................................7-9
Symbol Definitions ..................................................................................................7-16
Safety Considerations ...............................................................................................7-19
Electromagnetic Compatibility ................................................................................7-22
Reducing Electromagnetic Interference ........................................................................ 7-22
Restrictions for Use ...................................................................................................... 7-23
Immunity Level (Devices with Serial Numbers US001XXXXX) ............................... 7-23
Emissions and Immunity (Devices with Serial Numbers US002XXXXX or greater) . 7-23
Guidance and Manufacturer’s Declaration (Devices with Serial Numbers US002XXXXX
or greater) ...................................................................................................................... 7-24
Recommended Separation Distances ............................................................................ 7-30
ix
1Introduction
Who Should Use this Manual
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.
For additional documentation on the HeartStart XL, visit our web site at:
www.medical.philips.com/goto/productdocumentation
1
Web-Based Training
Web-based service training for the M4735A HeartStart XL
Defibrillator/Monitor is available. You can access the training through the
InCenter web site at incenter.medical.philips.com. Contact your Philips
representative to get access to the InCenter web site.
1-1
Overview
Defibrillator/Monitor
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.
Optional pulse oximetry (SpO
) monitoring is available in both modes, as
2
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
HeartStart XL-compatible Data Card (see Chapter 5 for a listing) 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.
NOTE 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.
1-2 Introduction
Overview
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).
1
z M4739A SpO
Consult your sales representative or dealer or distributor for the latest details.
upgrade. (adds SpO2).
2
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.
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 5-19.
M4735A Service Manual 1-3
Overview
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 chapter are as follows:
Section Page
Required Testing Levels 2-2
Test and Inspection Matrix 2-4
Overview
2
Test Equipment 2-9
Configuration and Diagnostic Modes 2-10
The Language Support Tool 2-12
Performance Verification Tests 2-14
M4735A Service Manual 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 2-15).
z Run the Extended Self Test (page 2-24).
z Print and Verify the System Log (page 2-22).
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 2-15).
z Run the Extended Self Test (page 2-24).
z Run the Printer Test (page 2-29).
z Print and Verify the System Log (page 2-22).
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 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 G roup N a me Test or Inspection to Perform Expected Test Results
Visual Inspection
(V)
Functional Checks
(F)
Extended Self Test
(X)
Inspect the unit, accessories,
cables, etc.for signs of wear,
damage, corrosion, or missing items, as described on
page 2-15.
In normal Operating Mode,
perform the following functional checks:
• ECG (page 2-17). • Waveform clear on display;
• Shock Advisory (page 2-18). • Shock Advised only when
• Synchronized Cardioversion
(page 2-19).
• SpO
(page 2-20). • 95% -100%
2
In Diagnostic Mode, run the
Extended Self Test (page 2-
24). Includes Data Card Test
and time/date check.
If no unusual damage, no corrosion, no missing items: x=p.
then Visual Inspection passes
If all functions respond as
expected: x=p
HR correct on display; HR
alarm works. Leads off, pads
off indicators as expected.
appropriate
• Shock delivered with correct
timing (<
then Functional Check passes
If “Pass” reported on all tests
applicable to the device configuration and options: x=p.
then Extended Self test passes
60msec)
Data to Record
x = p (pass) or f(fail)
V:x
Example V:p
F:x
Example F:p
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 G roup N a me Test or Inspection to Perform Expected Test Results
User Interface Tests
(U)
ECG Tests (E) In Diagnostic Mode, run the
• In Diagnostic Mode, run the
following tests (page 2-27):
• Controls Test • All keys respond as expected
• Display Test • Visual Pass assessment by
• Audio Test • Alerts, alarms, and tones are
• Printer Test • Print quality is adequate; no
ECG Tests (page 2-32):
• Status messages (lead, pad,
DSP)
If all data within limits, all
checks pass: x=p
service personnel
clearly heard
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
Amplifier gain
• Pads Peak to Peak (Monitor)
• Leads Peak to Peak (Diagnos-
tic)
Amplifier noise
• Leads Peak to Peak (Diagnostic) - cc
• Pads Peak to Peak (Monitor) dd
PCI measurement
• PCI - Paddles in Pockets • 50 ± 30 Ω
• PCI - Paddles open • >
Pacing Test (P) In Diagnostic Mode, run the
Pacing Test (page 2-37):
in factory manufacturing.
• 1000uV
• 1000uV
• 0
• 0
then ECG Test passes
All data within limits, all
checks pass: x=p
±10%
±10%
± 30uV
± 30uV
1250 Ω
P:x
Example: P:p
• (70 ppm) 30 mA • 30 mA ± 5 mA
• (180 ppm) 200mA • 200mA± 20 mA
M4735A Service Manual 2-5
Test and Inspection Matrix
Table 2-1 Performance Verification and Safety Tests (Continued)
Test G roup N a me Test or Inspection to Perform Expected Test Results
Defibrillator Test AC Power (DA)
(if AC Power used in
normal operation)
Using only AC power, enter
Diagnostic Mode and run the
Defibrillator Test (AC Power
at 200Joules) (page 2-39):
Measured by
Defibrillator Analyzer:
• Delivered energy
Displayed by
M4735A:
• Available Energy after Shock • 0
• Msec to charge • <
• Delivered energy
• Impedance • 42 to 57 Ω
• Defib errors • None (0)
All data within limits, all
checks pass: x=p. If the measurements are as follows:
± 30J
• 200
15000 msec
• Actual delivered energy ±7%
then the Defibrillator test (AC
Power) passes
Data to Record
x = p (pass) or f(fail)
DA:x
Example: DA:p
Defibrillator Test Battery Power (DB)
Defibrillator
Disarm Test (D)
Using only battery power,
enter Diagnostic Mode and
run the Defibrillator Test (at
200Joules) (page 2-40).
Measured by
Defibrillator Analyzer
• Delivered energy • 200 ± 30 J
Displayed by
M4735A
• Available Energy after Shock • 0
• Msec to charge • <
• Delivered energy
• Impedance • 42 to 57 Ω
• Defib errors • None (0)
Enter Diagnostic Mode and
run the Defibrillator Disarm
Test (page 2-41)
All data within limits, all
checks pass: x=p
If the measurements are:
3000 msec
• Actual delivered energy ±7%
then the Defibrillator test (Battery Power) passes
All readings as expected: x=p.
No errors reported.
then the Defibrillator Disarm
test passes
DB:x
Example: DB:p
D:x
Example: D:p
2-6 Performance Verification and Safety Tests
Table 2-1 Performance Verification and Safety Tests (Continued)
Test and Inspection Matrix
Test G roup N a me Test or Inspection to Perform Expected Test Results
Safety Tests Indicate test results as
follows:
Earth Leakage
Current (S1)
Patient Lead Leakage (S3)
Earth Leakage Current
NC (Normal Condition) - aaa
Earth Leakage Current
SF (Single Fault -open neutral)
- bbbb
ECG Patient Cable If readings are as expected: S3:P/aa/bb/cc/dd/ee/ff/ggg/
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
2
• 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
Safety test passes
Leakage
2
M4735A Service Manual 2-7
Test and Inspection Matrix
Table 2-1 Performance Verification and Safety Tests (Continued)
Test G roup N a me Test or Inspection to Perform Expected Test Results
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
<
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)
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
2-8 Performance Verification and Safety Tests
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 trun-
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
ECG simulator
ECG simulator
cated exponential waveform.
2
• < 20 joules: ≤ ±0.4 joules
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
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
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.
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 Set-
tings to Data Card? press .
z To load configuration settings from a Data Card, select Load Settings
from Data Card and press . When prompted with Load Settings
from Data Card? press .
ENTER
ENTER
ENTER
SAVE
ENTER
LOAD
2-10 Performance Verification and Safety Tests
Configuration and Diagnostic Modes
5. Exit Configuration Mode.
z To exit Configuration Mode, turn the unit off.
z Wait 2 seconds. Remove the Data Card by pressing the black eject
button and pulling the Data Card from the compartment.
Figure 2-1 Softkey Numbers
4567
2
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 2-22.
z Run the Extended Self Test. See "Extended Self Test" on page 2-24.
z Run other Diagnostic Tests. See "Diagnostic Tests" on page 2-21.
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.
M4735A Service Manual 2-11
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.
option; 3) to program in the serial number. These tasks need
2
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
capability.
2
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.
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 2-10 to save
the configuration to a Data Card.
2-12 Performance Verification and Safety Tests
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 Ye s to set the unit’s language. Do not press any keys or touch
the unit until the process is complete.
2
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 2-10).
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.
M4735A Service Manual 2-13
Performance Verification Tests
Performance Verification Tests
This section gives instructions for running Performance Verification tests on
the M4735A. The tests are sequenced to check more basic functions first, 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 2-17
Diagnostic Tests 2-21
Safety Tests 2-42
Battery Capacity Test 2-46
2-14 Performance Verification and Safety Tests
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