Edition 1
Printed in the USA
Publication number M4735-90900
The information in this manual appli es
to the M4735A Heartstream XL
Release A.0.0. This informatio n is subject to change without notice.
Agilent Technologies shall not be liabl e
for errors contained herein or for incidental or consequential damages in connection with the furnishing,
performance, or use of this material.
reproduced, or translated to another language without prior written consent of
Agilent Technologies.
WARNING
Radio Frequency (RF) interference
from nearby transmitting devices may
seriously degrade performance of the
M4735A. Electromagnetic compatibility with surrounding devices should be
assessed prior to using the defibrillator.
CAUTION
Use of supplies or accessories other
than those recommended by Agilent
Technologies may compromise product
performance.
THIS PRODUCT IS NOT INTENDED
FOR HOME USE.
IN THE U.S., FEDERAL LAW
RESTRICTS THIS DEVICE TO SALE
ON OR BY THE ORDER OF A PHYSICIAN.
Medical Device Directive
The M4735A Defibrillator/Monito r
complies with the requirements of the
Medical Device Directive 93/42/EEC
This Service Manual provides the information needed to successfully service the Agilent M4735A Heartstrea m XL Defi bril lato r/Mon itors . The i ntende d user s of t his man ual are technical personnel who have been trained in the safe and proper servicing of
the M4735A. 1
Overview
In this chapter, you’ll find general information that you should become familiar with before servicing the M4735A. Detailed information regarding controls, operation, and capabilities of the instrument can be found in the User’s
Guide (M4735-91900) that was shipped with the product. We recommend
you review the User’s Guide before servicing this device. Th is Service Man -
ual assumes you are familiar with the controls and with basic operations.
Defibrillator/Monitor
The M4735A is a biphasic, semi-automatic external defibrillator. This portable, lightweight device offers two modes of operation for defibrillation:
l
Semi-Autom atic External Defibrillat ion (AED) Mode
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Manual Mode
1
In AED Mode, the M4735A analyzes the patient’s ECG and advises the clinician whether or not to deliver a shock. Defibrillation is performed through
multifunction defi b electrode pads.
In Manual Mode, the M4735A turns control of the defibrillation process over
to the clinician. The c li ni ci an a nal yze s the patient’s ECG, decides if defibrillation is advised, and deter mines t he ener gy s etti ng for def ibrill ation . Defibr illa tion is performed eit her through mu ltifunc tion defib el ectrode pa ds or throu gh
paddles.
Manual Mode also allows the c linician to perform synchroni zed cardiover sion
and offers optional noninvasive pacing (using a monophasic waveform).
ECG monitoring can be accomplished in either mode using one of 3 methods:
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ECG from the defib pads
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3-lead ECG using separate monitoring electrodes
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Optional 5-lead ECG using separate monitoring electrodes.
Optional pulse oximetry (SpO
well.
The M4735A automatically stores critical events, such as shocks and alarm
violations, in its internal memo ry. An Event Summary may be printed at any
time. The M4735A also enables you to store data and events on an M3510A
) monitoring is available in both modes, as
2
1-1
6/29/00
Overview
Data Card for downloading to the CodeRunner Web Data Management System.
Batteries
The M4735A is powered by a rechargeable Sealed Lead Acid (SLA) battery
(M3516A). Proper care of these batteries will ensure that they have the
energy required to operate the M4735A and deliver the appropriate therapy
(See "Battery Maintenance" section in User’s Guide).
NOTEThe defibrillator will take longer to charge when powered with AC without a
battery installed. To ensure optimal performance, alwa ys have a fully char ged
battery in the defibrillator, even when using AC power.
Installation
The M4735A does not require installation. The User’s Guide describes the
setup required before pla ci ng the devi ce into service, as well as configuration
options.
Upgrades
Upgrades are availabl e to add spe cific funct ionalit y to units in the fi eld. As of
the publication of this manual, these upgrades are:
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M4738A Pacing Upgrade (adds pacing).
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M4739A SpO2 upgrade. (adds SpO2).
Consult your sales representative or dealer or distributor for the latest details.
Preventive Maintenance
Preventive maintenance and periodic operational checks are intended to be
performed by the user. Both topics are covered i n the Ma inten ance cha pter o f
the User’s Guide.
1-2Introduction
Overview
Repair Philosophy
Defibrillator/Monitor
The repair philosophy of the M4735A i s subassembly repl acement. Examp les
of subassemblies are the printer, the Control Printed Circuit Assembly (PCA),
and selected connectors and other items. Repairs that involve replacing components on a PCA are not supported.
CAUTIONIndividual component replacement should not be attempted outside of a fac-
tory authorized repair facility. Component level repair is extremely difficult
due to the extensive use of surface mount technology and the high parts-density on the circuit boards. Unauthorized component replacement can impair
performance of the M4735A.
Batteries
The repair philosophy for the SLA battery (M3516A) is unit replacement.
These items are not repaired in the field.
For information on ordering replacements, see "Supplies & Accessories" on
page 5-18.
1
M4735A Service Manual1-3
Overview
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1-4Introduction
2Performance Verification and Safety Tests
Overview
This chapter describes the tests and inspections required to verify performance of the M4735A Portable Defibrillator/Monitor.
Chapter Contents
The major sections of this ch apter are as fo llows:
SectionPage
Mandatory Testing2-2
Test Matrix2-4
Test Equipment2-8
Configuration and Diagnostic Modes2-10
The Software Support Tool2-12
Performance V eri fic ati on2-14
2
2-1
6/29/00
Mandatory Testing
Mandatory Testing
The Performa nce Verification Tests in this chapter are intended to verify
proper operation of the M4735A following repair. The level of testing
required corresponds to the t ype of r epair p erforme d, and is divide d into 3 c ategories: External/No Trouble Found, Printer Replacement, and Internal Repairs. Each of these categories is described below.
External Repairs/No Trouble Found
External Repairs are those involving the repair or replacement of one or
more of the items below. No Trouble Found applies when no malfunction
can be found, or when the problem appears to be due to improper use. In
either situation, the key point is that the case has not been opened.
The following testing is required after an External Repair or when the out-
come of the service is No Trouble Found (when the case has not been opened):
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Perform the Visual Inspection (page 2-15).
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Run the Extended Self Test (page 2-22).
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Print and Verify the System Log (page 2-20).
2-2Performance Verification and Safety Tests
Mandatory Testing
Printer
If the printer was replaced , and the case was not opened, the following tests
are required:
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Perform the Visual Inspection (page 2-15).
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Run the Extended Self Test (page 2-22).
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Run the Printer Test (page 2-27).
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Print and Verify the System Log (page 2-20).
Internal Repairs
If the case was opened (regardless of what the repair involved), all of the Performance Verification Tests must be performed, beginning with "Visual
Inspection" on page 2-15.
2
M4735A Service Manual2-3
Test Matrix
Test Matrix
The matrix in Table 2-1 summarizes performance verification tests and
inspections for the M4735A; including test name, test or inspection to perform, expected test results, and data to record.
Table 2-1 Performance Verification and Safety Tests
Test Group Name
Visual Inspection
(V)
Functional
Checks (F)
Extended Self
Test (X)
Test or Inspection to
Perform
Inspect unit, accessor ies,
cables, etc. as described
on page 2-15.
In normal Operating Mode,
perform the following functional checks:
• ECG (page 2-16).• W aveform c lear on displa y;
• Shock Advisory (page 2-
17).
• Synchronized Cardioversion (page 2-18).
(page 2-18). • 95% -100%
• SpO
2
In Diagnostic Mode, run
the Extended Self Test
(page 2-22). Includes Data
Card Test and time/date
check.
Expected Test Results
• No unusual damage, no
corrosion: x=p.
• All functions respond as
expected
HR correct on display; HR
alarm works
• Shock Advised only when
appropriate
• Shock delivered with correct timing
"Pass" reported on all tests
applicable to the device configuration and options: x=p.
Data to Record
x = p (pass) or f(fail)
V:x
Example V:p
F:x
Example F:p
X:x
Example X:p
User Interface
Tests (U)
• In Diagnostic Mode, run
the following tests (page
2-25):
• Controls Test• All keys respond as
• Display Test • Visual Pass assessment by
• Audio Test• Audio Pass assess ment by
• Printer Test• Print quality: visual Pass
All responses as expected.
expected
service personnel
service personnel.
assessment by serv ice personnel
• Print speed: 25 mm
(1.25mm)
± 5%
U:x
Example: U:p
2-4Performance Verification and Safety Tests
Table 2-1 Performance Verification and Safety Tests
Test Matrix
Test Group Name
ECG Tests (E)In Diagnostic Mode, run
Test or Inspection to
Perform
the ECG T ests (page 2-29):
• Status messages (lead,
pad, DSP)
• DC offset • Ignore - used only in fac-
Amplifier gain
• Pads Peak to Peak (Monitor) - aaaa
• Leads Peak to Peak (Diagnostic) - bbbb
Amplifier noise
• Leads Peak to Peak (Diagnostic) - cc
• Pads Peak to Peak (Monitor) - dd
Expected Test Results
All data within limits, all
checks pass: x=p
• "Good" displayed for all
three
tory manufacturing.
• 1000mV ±10%
• 1000mV
• 0 ± 30uV
• 0 ± 30uV
±10%
Data to Record
x = p (pass) or f(fail)
E: aaaa,bbbb,cc,dd,
ee,fff f,x
Example:
E:1000,1000,20,20,
50,2000,p
2
PCI measurement
• PCI - Paddles in Pockets – ee• 50 ± 30 Ω
• PCI - Paddles open – ffff• >
Pacing Test (P)In Diagnostic Mode, run
the Pacing Test (page 2-
33):
• 30 mA – aa• 30 mA ± 5 mA
• 200mA – bbb• 200mA± 20 mA
1250 Ω
P:aa,bbb
Example: P:31,198
M4735A Service Manual2-5
Test Matrix
Table 2-1 Performance Verification and Safety Tests
Test Group Name
Defibrillator T es t AC Power (DA)
(if AC Power used
in normal operation)
Test or Inspection to
Perform
Using only AC power,
enter Diagnostic Mode
and run the Defibrillator
Test (AC Power at 200J)
(page 2-35):
Expected Test Results
Measured by
Defibrillator Analyzer:
• Delivered energy - aaa
• 200
± 30J
Displayed by
M4735A:
• Available Energy after
Shock
• Msec to charge – bbbbb• <
• Delivered energy - ccc• Actual delivered energy
• Impedance - dd• 42 to 57 Ω
• Defib errors • None (0)
• 0
15000 msec
(aaa) ±7%
Data to Record
x = p (pass) or f(fail)
DA:aaa,bbbbb,ccc,dd
Example:
DA:198,13000,195 ,48
Defibrillator T es t Battery Power
(DB)
Defibril lator Disarm Test (D)
Using only battery power,
enter Diagnostic Mode
and run the Defibrillator
Test (Battery Power at
200J) (page 2-36).
Measured by
Defibrillator Analyzer
• Delivered energy - aaa• 200 ± 30 J
Displayed by
M4735A
• Available Energy after
Shock
• Msec to charge – bbbb• <
• Delivered energy - ccc• Actual delivered energy
• Impedance - dd• 42 to 57 Ω
• Defib errors• None (0)
Enter Diagnostic Mode
and run the Defibrillator
Disarm Test (page 2-38)
• 0
3000 msec
(aaa)
±7%
All readings as expected:
x=p
DB:aaa,bbbb,ccc,dd
Example:
DB:198,2545,200,50
D:x
Example: D:p
2-6Performance Verification and Safety Tests
Table 2-1 Performance Verification and Safety Tests
Test Matrix
Test Group Name
Safety Test (S)Test both leads and pads,
Test or Inspection to
Perform
and indicate test results
as follows:
External Leads: t=C
External Pads: t=B
Earth Leakage
Earth Leakage
(Normal Co ndition) - aaa
Earth Leakage
(Single Fault) - bbbb
Patient Lead Leakage
• Source
(Normal Condition) - ccc
• Source
(Single Fault Condition) ddd
• With Mains on appli ed p art
(Single Fault condition) eeee
Table 2-2 lists the equipment needed to pe rf orm t he Performance Verification
tests, and provides specifications for commercially available analyzers and
simulators. Test equipment is called out within each test procedure when
needed. In addition, a digital voltmeter is also useful.
A 50 ohm test load is available from Agilent Technologies (M1781A).
Table 2-2 Equipment List
Equipment/TestSpecifications
ECG Simulator
Calibrated Leads ECG simulator
• Amplitude accuracy±2%
• Rate accuracy±2%
Calibrated Paddles
• Amplitude accuracy±2%
• Rate accuracy±2%
Defibrillator Analyzer
Waveform compatibilityMeets 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
Cardioversion measurement range:–150 to +150 ms
ECG simulator
truncated exponential waveform.
2-8Performance Verification and Safety Tests
Table 2-2 Equipment List
Equipment/TestSpecifications
Pacer tester
Load impedance:≤400 Ω
measurement accuracy
Current
• 30 mA–50 mA:<±2 mA
• 50 mA–200 mA:<±4%
measurement accuracy
Rate
• 40–180 ppm:<±0.5%
Waveform duration accuracy:
• 40–180 ppm:±1ms
Test Equipment
2
M4735A Service Manual2-9
Configuration and Diagnostic Modes
Configuration and Diagnostic Modes
The instructions below describe how to enter Configuration Mode and Diagnostic Mode.
Configuration Mode
These instructions describe briefly how to use Configuration Mode. See the
User’s Guide for details on configuration settings and what effect they have.
1.Power off.
Make sure the unit’s power is off.
2.Insert a Data Card.
If you intend to save the configuration to a Data Card (or load the configuration from a Data Card), insert the Data Card now.
NOTETo avoid possible confusion, designate one Data Card as the "Configuration
Card" and label it c le arl y. Keep this card physically separate from cards used
by the clinical staf f for data storage.
3.Enter Configuration Mode.
Press softkeys 4 and 5 at the same time, and hold them down while turning the power on. See Figure 2-1 for softkey numbering.
4.Select and manage Configuration choices.
l
To select a configuration, press the and softkeys to move up
ENTER
Settings
item is highlighted. Then
Save Settings
Save Settings to
or down the list until the desired
press the softkey to access those settings.
l
To print out a strip with all the current configuration choices, select
Print All Settings
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To store the configuration settings on a data card, select
to Data Card
Data Card? press .
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To load configuration settings from a Data Card, select Load Settings
ENTER
and press .
and press . When prompted with
SAVE
from Data Card and pres s . When pr ompte d wi th Load Settings
from Data Card? press .
5.Exit Configuration Mode.
ENTER
ENTER
LOAD
To exit Configuration Mode, turn the unit off. Remove the Data Card.
2-10Performance Verification and Safety Tests
Figure 2-1 Softkey Numbers
Softkeys
4 5 6 7
Configuration and Diagnostic Modes
2
Diagnostic Mode
These instructions describe how to enter Diagnostic Mode. Once in Diagnostic Mode, you can do the following:
l
Print the System Log. See "System Log" on page 2-20.
l
Run the Extended Self Test. See "Extended Self Test" on page 2-22.
l
Run other Diagnostic Tests. See "Diagnostic Tests" on page 2-19.
1.Power off.
Make sure the unit’s power is off.
2.Enter Diagnostic Mode.
Press softkeys 4 and 6 at the same time, and hold them down while turning the power on. See Figure 2-1 for softkey numbering.
3.Wait for the unit to initialize.
This may take several seconds. The unit is ready to proceed when the
screen cursor responds to softkey inputs.
4.Select the desired test or function.
To select a test, press the and softkeys to move up or down the
list until the desir ed te st is h ighli ghted. Then p ress the softkey to
start that test.
ENTER
5.Exit Diagnostic Mode.
To exit Diagnostic Mode, turn the unit off.
M4735A Service Manual2-11
The Software Su pport Tool
The Software Support Tool
The Software Support Tool (M4735-87890) allows field service personnel to
perform 2 tasks: 1) to enable the SpO
number. These tasks need to be performed under the following circumstances:
l
The Control PCA has been replaced.
The Control PCA contains all the operating software, configured
for the installed hardware. It also contains the unit’s serial numbe r,
which was programmed in during manufacturing.
The new Control PCA must be programmed to recognize the
hardware installed in this unit, and to contain that unit’s
serial number.
l
The unit has received an upgrade adding the SpO2 capability.
The added hardware will not be automatically recognized. The
Control PCA must be programmed to recognize the new hardware
installed.
option, and 2) to program in the serial
2
Using the Support Tool
1.Prepare the unit.
a.Have unit power off, and have either a fresh battery installed or the
AC power cord plugged in.
b. Insert the Support Tool data card into the unit.
c.Turn unit power on.
2.Follow the screen prompts.
a.Select whether SpO
b. Program in the unit’s serial number.
l
If this is an Sp O2 upgrade, the serial number should already be
present. In this case, verify it against the factory-applied label on
the bottom of the case.
l
If this is a Control PCA replacement, program in the serial number found on the factory-applied label on the bottom of the case
using the softkeys as i nstructe d on the screen. Be sure to program
it in accurately, as the serial number is used for all repair history
tracking.
hardware is installed or not as appropriate.
2
c.Check all the displayed information carefully before proceeding.
l
If the displayed information is correct, follow the screen prompts
to save the configuration.
2-12Performance Verification and Safety Tests
The Software Support Tool
l
If any of the information is incorrect, follow the prompts to NOT
save the configuration, then start over by powering the unit off,
then back on.
3.Turn off the power and remove the Data Card.
4.Check the customer configuration.
a.Turn the unit back on and enter Configuration Mode (see "Configura-
tion Mode" on page 2-10).
b. Print the configuration and check it against the printout from before
the servici ng began. Reset the configuration (or load it from a Data
Card) as needed.
5.Verify performance.
Perform Performance Verification Testing as described in "Performance
Verification and Safety Tests" starting on page 2-1.
2
M4735A Service Manual2-13
Performance Verification
Performance Verificatio n
This section gives instructions for running Performance Verification tests on
the M4735A. The tests are seque nced to check more basic fu nctions fi rst, and
then build on that to check more complex functions. We recommend you
perform these tests in this sequence. If desired, you can make copies of the
Test Results Matrix (page 2-4) and use it to record results.
Evidence of liquid spill. Check inside the printer bucket and
clean out any ac cumulation using glove s and an appr oved c leaner.
l
Residue on the therm al printhead.
l
Printer roller wear.
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Wear or damage to power cord and associated strain relief.
l
Corrosion on connector pins, printer parts, or battery contacts.
2
Pass: Only normal wear, no damage serious enough to inhibit
performance. No corrosion visible.
2.Check the consumables.
Check the ECG electrodes and defibrillator pads for freshness (data code
or expiration date) and condition.
Pass: Electrodes and pads are within their expiration date and
appear usable. Packaging is unopened and shows no tears or punctures.
No corrosion visible on connector sockets, electrodes, or pads.
M4735A Service Manual2-15
Performance Verification
Functional Checks
The following functional checks exercise the basic functions of the defibrilla-
tor/monitor. They are intended as a broad check of the unit’s performance,
and are designed to complement (not replace) the Diagnostic Tests described
later.
If all elements of a test pass, record that test as a P A SS and re tu rn to the main
diagnostic menu by pressing . If there is any failure, begin trouble-
shooting and repairing as needed. See "Troubleshooting" on page 3-1.
The Functional Checks include:
This section describes how to check the oper ation of the ECG func tions. Each
of the ECG checks assumes the unit and the simulator are still set up as they
were at the end of the previous ECG check.
To check ECG display and Heart Rate (HR) functions:
1.Set up the simulator.
a.Connect the ECG simulator to both the Pads input and the 3- or
5-lead ECG cable.
b. Set the simula tor for normal sinus rhythm (NSR), 1mV amp litude, at
some nominal rate (e.g., 60 bpm).
2.Set up the M4735A.
Set the M4735A to Manual operating mode (not Diagnostic Mode).
3.Check the displayed ECG.
Using the softkey, verify that the display shows a normal
ECG with a clean baseline for both Pads and Lead II.
LEAD SELECT
4.Check the Heart Rate (HR).
Verify that the Heart Rate (HR) displayed is correct.
5.Check Leads Off.
a.Disconnect the ECG simulator from the pads cable and ver ify that the
display shows a das hed li ne in pla ce of the wavefo rm and t hat the u nit
both alarms and gives the Pads Off message
b. If using a 5-lead ECG cabl e, set the unit to monitor from th e V lead.
2-16Performance Verification and Safety Tests
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