Spacelabs Healthcare Lifecard CF, Lifecard 12 User manual

1

Lifecard CF Service Manual

and

Lifecard 12

Firmware revision 7

Lifecard CF

18-0583 Rev. C

Service Manual

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18-0583 Rev.C

Contents Page

1. PRODUCT OVERVIEW 7

1.1 INTRODUCTION 7

1.2 SpeciÞ cation 9

1.2.1 Standard Recording Mode – ECG Inputs 9

1.2.2 Standard Recording Mode - Pacemaker Pulse Detection 10

1.2.3 Standard Recording Mode - Data Storage 10

1.2.4 User Interface 10

1.2.5 Power Requirements 11

1.2.6 Extended Recording Mode 11

1.2.7 Additional SpeciÞ cations in 12-Lead Mode 12

1.2.8 Physical and Environmental 12

1.2.9 Electro-Magnetic Compatibility 13

2. SAFETY AND REGULATORY 15

2.1 Intended Use of Equipment 15

2.2 Safety ClassiÞ cation 15

2.5 Explanation of Markings 17

3. LCF BUILT-IN TESTS 21

3.1 Primary Built-in Tests 21

3.2 Second Level Built-in Tests 21

3.3 Third Level Built-in Tests 21

3.4 User Level Tests 22

3.5 Fault Protection While Recording 22

3.6 Lifecard CF Menu Options 23

3.6.1 Main Menu Options 23

3.6.2 Setup Menu 25

3.7 Lifecard CF Sounds 28

3.8 Error and Warnings Displays 29

3.9 Decontamination 32

3.10 Patient Cable 33

3.11 Battery 34

3.12 Battery Check 34

3.13 Checking the Hardware & Software Revision 34

3.14 Compact Flashcard 35

Lifecard CF Service Manual

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4. Test Procedure 37

4.1 Checking the Patient Cable 37

4.2 LC12 Varios Yoke Assembly 37

4.3 Lifecard CF Check-out 39

5. Spares & Part Numbers 41

6. Assembly Views 43

6.1 Front Assembly - Front View - Complete 43

6.2 Front Assembly - Rear View 44

6.3 Intermediate Moulding 45

6.4 Circuit Board 46

6.5 Patient Cable Mounting with Clip 48

6.6 Short Patient Cable 49

6.7 Varios with 46-1123 Cable 46-1152 50

6.8 Varios Lead Parts 51

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18-0583 Rev.C

©Copyright 2010 Spacelabs Healthcare Ltd.

1 Harforde Court, John Tate Road, Hertford. SG13 7NW

Lifecard CF Service Manual

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18-0583 Rev.C

1. PRODUCT OVERVIEW

1.1 Introduction

The Lifecard CF is a compact Holter Ambulatory ECG Recorder
utilising a digital storage technique to store the ECG recording onto
a Compact Flash (CF) card. The Lifecard CF provides continuous
recording of 2 or 3 leads of ECG for up to 48 hours in standard mode
and up to 7 days in extended mode.

The Lifecard 12 option provides continuous recording of 12 leads of
ECG for a period of 24 hours. The recorder has a built in display for
you to monitor the ECG and pacing detection during hook-up. This
enables you to verify the ECG quality before starting the recording.
Menu options are selected using the 2 buttons on the front of the
recorder unit.

The Lifecard CF requires one AAA battery. The patient cables for the
Lifecard CF are designed to prevent accidental disconnection from the
recorder by the patient.

The Patient Event button on the front of the recorder unit enables the
patient to indicate symptomatic episodes in the recording for correla­tion with the patient diary. Pacemaker pulse detection may be enabled
and disabled by the physician or cardiac technician. Recordings may
be analysed using a Spacelabs Healthcare PathÞ nder, Impresario, or
Lifescreen Holter analysis system, if they have compatible hardware
and software. (Lifescreen is incompatible with 12-lead recordings.)

The Lifecard CF comprises two sections, the ‘Recorder Unit’ and the
‘Patient Cable Unit’.

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LIFECARD CF RECORDER UNIT

Lifecard CF

Display

Yellow Button

Menu Navigation

and

Patient Event

Microphone

Green Button

Menu

Selection

and

Patient Event

Loudspeaker

Patient Cable Unit

Patient Cable

Electrode Color

Code label

Belt Clip

(long cables only)

Slot for Neck

Lanyard

Attachment

Recorder Unit

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Patient Cable

Varios Active Yoke

1.2 Specifi cation

1.2.1 Standard Recording Mode – ECG Inputs

Channels 3, type BF applied part patient isolation

types 2 or 3 channel 3 electrode, 2
4 electrode, 3 channel 6 electrode with
detachable leadwires.

Input impedance > 5Mȍ Ohms

Input DC offset ± 300 mV, with saturation

recovery circuit (3 seconds max)

CMRR > 60 dB at 10Hz, > 80 dB at 50 Hz and
above, 2 Vpp signal

Dynamic range 10 mV

Resolution 2.5ȝV

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Calibration ± 5%

Bandwidth 0.05 - 40 Hz (-3 dB)

Sampling rate 1024 samples per second per channel

Noise fi lter Linear phase Þ lter effective from 60Hz to

> 1MHz, 128 samples per second out
put rate

1.2.2 Standard Recording Mode - Pacemaker Pulse
Detection

Sensitivity 7 mV nominal, channels 1 and 2 only

Noise rejection > 50 mVpp for sinusoids up to 200 Hz

CMRR 2 V common mode spikes are rejected

Refractory period 40 ms

1.2.3 Standard Recording Mode - Data Storage

Media type Removable card, CompactFlash Association

standard (Type 1)

Data types Full disclosure ECG, with pacing and patient
event markers. Recording Time and Date.
Patient name and record number
(PathÞ nder systems), Encrypted patient record
Þ le (CardioNavigator). 8 second voice recording.

Recorder serial number

Capacity req 15 Mbytes per channel per 24 hours eg.
a 48 hour three channel recording occupies
90 Mbytes

1.2.4 User Interface

Type Text menus with audio cues and keys for up, down

and select

Languages English, German, French, Italian, Spanish, Danish
and Polish languages also Hebrew patient ID support

Clock Clock and calendar (to 2098), selectable 12/24 hour
and US/European date formats. 13mm digit height for
patient use

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Basic features Pacing detection on/off, hook-up display,

voice recording for patient identiÞ cation

Ancillary features Identify and delete unread recordings,
warning/error screens for battery and
memory card conditions

Hook-up display Real time display of each channel, with 60
ȝV/30 ms resolution and pacing annotation

Set-up options Time and date, language, display contrast,
recorder identiÞ cation

1.2.5 Power Requirements

Disposable cell Single AAA alkaline (Duracell MN2400 or

equivalent), two 24 hour recordings or one 48
hour recording

Rechargable cell Single AAA nickel metal hydride (Ansmann
600 mAh or equivalent), one 24 hour
recording per charge

Battery check User is warned of poor battery condition
before recording

Clock battery Internal rechargeable cell, charged during re
cording. The clock is maintained
for > 3 months between recordings

1.2.6 Extended Recording Mode

Channels 2 channel recording, with pacing detection

Cable Types 2 channel 3 electrode or 2 channel 4 electrode

Resolution 10ȝV

Sampling Rate 256 samples per second per channel

Compression 10ȝV maximum compression error when

tested with MIT-BIH Arrhythmia and
Compression databases

Capacity required 90 Mbytes for dual channel 1 week

Disposable Cell AAA alkaline (Duracell MN2400 or equivalent)

for 1 week.

User Interface Includes an audible alarm to alert the
patient if an electrode becomes detached.
Sense current is < 10 nA.

Note: other specifi cations are the same as Standard Recording Mode.

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1.2.7 Additional Specifi cations in 12-Lead Mode

Channels Standard 12-lead, one neutral and nine active

electrodes

Cable types 10 electrode, deÞ brillation protected, IEC
or AHA code

Isolation DEFIBRILLATION-PROOF TYPE
CF APPLIED PART

Input impedance 10 Mohm

Sampling rate 4096 samples per second per channel

CMRR > 80dB per IEC and ANSI/AAMI methods

Suppression Active neutral system (‘right leg drive’)

Resolution 0.6ȝV

Noise < 0.6ȝV RMS

Pacing detection >2mV, 200ȝs to 5ms pulse in any electrode

Capacity required 256 MByte card for 24 hour recording

Battery An alkaline AAA cell is required for

24 hour recording

Fault tolerance In the event of electrode detachment
noise is suppressed, and the available leads
are recorded (differential V leads only if R, L
or F is detached)

Note: other specifi cations are the same as Standard Recording Mode

1.2.8 Physical and Environmental

Dimensions 96 x 57 x 17.5mm with patient cable Þ tted

Weight Recorder body 55g: patient load 130g

including battery, card and typical
patient cable

User labelling Area provided is 52 x 15 mm

Temperature 0 to 45°C operation, -20 to 65°C storage

Humidity Operation or storage 5% to 95%,

non-condensing

Pressure Operation or storage air pressure
700 - 1060 mbar

Shock 1 m drop

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1.2.9 Electro-Magnetic Compatibility

General Complies with EN60601-1-2:1993 and ANSI/

AAMI EC38:1998

ESD (1) 4 kV air and 2 kV contact discharges: no inter
ruption in recorder function

ESD (2) 8 kV air and 6 kV contact discharges: no
damage to the recorder, recording
resumes automatically in < 10 s

Radiated emissions CISPR 11:1997, EN55011:1998 Group 1
Class B

Radiated immunity 3 V/m 26 MHz - 1 GHz, 80% AM modulated
at 5 Hz. Keyed carrier immunity to
EN50082:1996

This equipment has been tested and found to comply with the limits
for a class B computing device in accordance with the speciÞ cations
in Subpart J of Part 15 of FCC Rules, which are designed to provide
reasonable protection against interference to radio and television
reception.

This equipment generates and uses radio frequency energy and if not
installed and used in accordance with the instructions it may cause
interference. However, there is no guarantee that interference will not
occur in a particular installation. If this equipment does cause
interference to radio or television reception, which can be determined
by turning the equipment off or on, the user is encouraged to try to
correct the interference by one or more of the following measures:

• Reorient the receiving antenna

• Relocate the equipment with respect to the receiver

• Move the equipment away from the receiver

If necessary, the user should consult Spacelabs Healthcare or an
experienced radio/television technician for additional suggestions. The
user may Þ nd the following booklet prepared by the Federal
Communications Commission helpful:

“How to Identify and Resolve Radio-TV Interference Problems”

This booklet is available from the U.S. Government Printing OfÞ ce,
Washington, DC 20402, Stock No. 004-000-00345-4.

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2. SAFETY AND REGULATORY

2.1 Intended Use of Equipment

The Lifecard CF Holter recorder is to be used for the non-invasive
ambulatory recording of two or three channel electrocardiograms on a
standard commercial compact ß ash card.

The Lifecard 12 option is to be used for the non-invasive ambulatory
recording of 12-lead electrocardiograms on a standard commercial
compact ß ash card.

The recorder allows data to be collected over a continuous period of
up to 7 days whilst allowing the subject to perform most of their nor­mal daily activities.

The recordings can be analysed on compatible analysis systems from
Spacelabs Healthcare.

This device has been designed and supplied speciÞ cally for the long
term recording of electrocardiograms in ambulatory patients using
standard Holter monitoring techniques. It shall not be used for any
other purposes.

The device shall be operated only be suitably competent personnel
trained in the use and procedures of Holter electrocardiography for
diagnostic purposes.

The Lifecard CF comprises two sections; the ‘Recorder Unit’ and the
‘Patient Cable Unit’.

2.2 Safety Classifi cation

This device has been designed in accordance with EN60601 - 1 ,
“Medical
electrical equipment, Part 1: General requirements for safety”, as fol­lows:

1. EQUIPMENT with an INTERNAL ELECTRICAL POWER
SOURCE. The equipment is designed to be battery operated only.
Under NO circumstances shall a mains powered battery elimina­tor or any other external power source be used with the equip­ment.

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2. EQUIPMENT having a TYPE BF APPLIED PART. or

3. EQUIPMENT having a TYPE CF APPLIED PART if so marked.

4. IPX4 EQUIPMENT protected against the ingress of splashing
water, if so marked. Otherwise, ORDINARY EQUIPMENT, without
protection against ingress of liquid.

5. Not suitable for use in the presence of a ß ammable anesthetic
mixture with air or with oxygen or nitrous oxide, or ß ammable
cleaning agents.

6. Rated for CONTINUOUS OPERATION.

7. EQUIPMENT with an APPLIED PART, speciÞ cally designed for
application where a CONDUCTIVE CONNECTION is made to the
PATIENT, but not directly to the heart. According to ANSI/AAMI
EC38:1998.Lifecard CF is Type 1 ambulatory ECG device.

2.3 Adjustment, replacement of parts,

maintenance and repair

The device requires no routine adjustments to maintain its operation.

The device contains no user serviceable parts. It shall be serviced
only by Spacelabs Healthcare or by an agent accredited by them to
service device of this type. Unauthorised repairs or dismantling of the
device will invalidate the guarantee.

2.4 Defects and abnormal stresses

For continued safety the device must not be maltreated, used outside
its speciÞ ed operation conditions, or stored outside its speciÞ ed stor-
age conditions.

Lifecard CF contains protection against electrostatic discharge, but
there is no protection against deÞ brillators. To avoid damage the
device should be removed before deÞ brillating. The Varios active yoke
and 46-1123 / 46-1127 patient cables have deÞ brillator protection.
(The protection is a combination of the cable and the yoke).

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Whenever it is likely that protection has been impaired, the device

CE Mark

Date of Manufacture

Manufacturer

Consult Documents
This symbol means you should read the
accompanying documents

EQUIPMENT having a TYPE BF APPLIED PART

EQUIPMENT having a DEFIBRILLATION-PROOF
TYPE CF APPLIED PART

Battery Eject symbol

shall be made inoperative and secured against any unintended opera­tion. The protection is likely to be impaired if, for example, the device
shows visible damage.

a) shows visible damage

b) fails to perform the intended measurements

c) has been subjected to prolonged storage under unfavorable
conditions

d) has been subjected to severe transport stresses

e) the device has been connected to a patient during deÞ brillation.

2.5 Explanation of Markings

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18-0583 Rev.C

Protected against ingress of splashing water when

the patient cable is Þ tted.

AECG-

Type 1 ambulatory ECG device according to ANSI/
AAMI EC38:1998

This product must be sent to separate collection
facilities for recovery and recycling

12 LEAD 9

Compatible with Varios Active Yoke & 10-electrode
cable

2.6 Warranty

Subject to the conditions set out below, Spacelabs Healthcare (“The
Company”) warrants that its Products will be free from defects in
material and workmanship for a period of 12 months from delivery.

This warranty is given by The Company subject to the following
conditions:

1. The Company shall be under no liability in respect of any defect arising from fair
wear and tear, willful damage, negligence, abnormal working conditions, failure
to follow instructions (whether oral or in writing), misuse, improper installation or
alteration or repair of the Products without The Company’s approval.

2. The above warranty does not extend to parts, materials or devices not manufactured
by The Company, in respect of which the Customer shall only be entitled to the
beneÞ t of any such warranty or guarantee as is given by the manufacturer to The
Company.

3. Subject as expressly provided here, all warranties, conditions or other terms
implied by statute or common law are excluded to the fullest extent permitted by
law.

4. Any claim by the Customer which is based on any defect in material or
workmanship of the Products shall be notiÞ ed to The Company immediately after
discovery of the defect. If the Customer does not notify The Company accordingly,
the Customer shall not be entitled to reject the Products and The Company shall
have no liability for such defect.

5. Where any valid claim in respect of any of the Products which is based on any
defect in the material or workmanship of the Products is notiÞ ed to The Company,
The Company shall be entitled to replace or repair (at The Company’s sole
discretion, either at the Customer’s premises or at The Company’s premises in
the United Kingdom) the Products (or part in question) but The Company shall
have no further liability to the Customer.

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Lifecard CF Service Manual

6. The Company shall not be liable to the Customer by reason of any representation,
or implied warranty, condition or other term, or any duty at common law, or for
any consequential loss or damage (whether for loss of proÞ t or otherwise), costs,
expenses or other claims for consequential compensation whatsoever arising
out of or in connection with any act or omission of The Company relating to the
manufacture or supply of the Products or use by the Customer.

7. Spacelabs Healthcare recommends the use only of approved accessories and
parts. The use of third party accessories may result in damage to recordings or
equipment, and may invalidate your warranty.

2.7 Contact Details

Spacelabs Healthcare Ltd
1 Harforde Court
John Tate Road
Hertford
SG13 7NW
United Kingdom

Tel: [phone]
Fax: [phone]

Spacelabs Healthcare Inc.
5150 220th Ave. SE
Issaquah,
WA 98029
USA

Tel: [phone]
Fax: [phone]

Web site: www.spacelabshealthcare.com

2.7

Modifi cations

For continued safety, the device shall not be subjected to any
Unauthorised modiÞ cations and must be used only for the purpose for
which it was originally supplied.

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Lifecard CF Service Manual

3. LCF BUILT-IN TESTS

3.1 Primary Built-in Tests

When a battery is inserted the internal functions of the microcontroller
are tested automatically. If any errors are found the recorder will start
to beep loudly, before the patient cable is Þ tted. The pattern of beeps
indicates the cause of the problem.

3.2 Second Level Built-in Tests

When the patient cable is Þ tted the microcontroller applies further
automatic tests before proceeding with normal operation. The integrity
of the complete operating programme is tested at this point.
If any errors are found the recorder will start to beep after the cable
has been Þ tted. The pattern of beeps again indicates the cause of the
problem.

3.3 Third Level Built-in Tests

Lastly, the microcontroller tests the remaining peripheral circuits, com­municating any errors with a text message on the LCD. The following
service screen codes are used:

0001 Oscillator/clock fault
0002 SRAM fault
0003 EEPROM data error (data includes the unit serial
number, etc.)
0004 ADC operation fault
0005 ADC calibration fault
0006 ConÞ guration fault
0007 LCD Voltage fault
0008 Varios Active Yoke EEPROM data error
012 (TIMI recorders only) Clock, EEPROM, SRAM or LCD
Voltage fault.

3.4 User Level Tests

Before commencing the recording the recorder checks all aspects that
are under the user’s control, and will display warning or error
messages as described in the user manual. Items checked include:

• Battery voltage

• Loss of time and date since last use

• CF card needs conditioning

• CF card contents- have they been read out for analysis?

• Patient cable type

If a recorder frequently requires the time and date to be entered or
corrected, it should be returned for service.

3.5 Fault Protection While Recording

During recording the recorder operation is supervised in various ways,
to ensure that all recorded data is correct and the recording is as
complete as possible:

• The battery level is continually monitored. Low battery shutdown
is described in the user manual.

• If the LCD is found to be in the wrong state the recorder will
re-load the display.

• Data written to the CF card includes error detection information
which is checked before analysis.

• The recorder shuts down immediately if the cable is removed.

• If the patient cable is removed and then replaced, the recorder
will continue after a countdown message. The analyser will dis­play a corresponding blank period in the ECG.

• The 32768Hz crystal is monitored via a watchdog to ensure that
it is operating correctly.

Other transient faults can cause a short blank in the ECG while the
recorder resets and restarts:

• Intermittent power supply, due to contact corrosion, bad joints,
or possibly severe shock.

• The recorder software running improperly (watchdog timer).

• Error messages from the CF card that cannot be resolved.

• Any other unexpected condition such as data errors due to large
electrostatic discharge.

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3.6 Lifecard CF Menu Options

The Lifecard displays are controlled by two buttons:

• The yellow Ÿ Up and ź Down button is used to move up and
down the menus, to highlight the menu option. You also use it to
choose which channel is displayed on the monitor.

• The green Ź Select button is used to select the highlighted
option.

3.6.1 Main Menu Options

Displays options for starting and setting up the recorder.

1. Lifecard CF Option

If alternative operating modes are available on your recorder and you
wish to use them, contact Spacelabs Healthcare Ltd. for the
appropriate user manual.

2. Pacing option

Use this option to select or deselect pacing detection.

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3. Start... Option

Select Start when you want to make a recording in Standard

Recording Mode, up to 48 hours of 2 or 3 channel ECG, or 24
hours of 12-lead ECG.

4. Start Week ...Option

Select Start Week when you want to make a recording in Extended
Recording Mode, to record up to 7 days of continuous 2 channel ECG.

5. Recorder ID

This is a name or number you have chosen for the recorder using an
option in the Set Up menu. Your chosen ID will appear in the Main
Menu and on PathÞ nder reports.

There is a space inside the recorder unit for you to affi x a bar code or
similar.

6. Set Up Option

Select this option to conÞ gure the recorder.

7. Language Option

Select this to change the language displayed on the monitor. Keep
pressing the green Ź Select button to switch between the languages
until the correct one is displayed.

8. About option

This option displays the Software Version number and Hardware
Serial number. Pressing the green Ź Select button returns you to the
Main Menu.

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Lifecard CF Service Manual

3.6.2 Setup Menu

1. Contrast Option

Displays a bar indicating the current setting of the contrast.

The display can be darkened or lightened by pressing the yellow Up
or Down button. Press the green Select button to return to the Set Up
Menu.

2. Time Adjustment Option

This option enables you to select a 12 or 24 hour clock display. Use
the yellow Ÿ Up or ź Down button to change the selection and then
press the green Ź Select button to select it.

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Adjust the hours by pressing the yellow Ÿ Up or ź Down button until
the correct one is displayed, then press the green Ź Select button.
This moves the highlight onto the minutes which you then adjust in the
same way.

Pressing the green Ź Select button again returns you to the Set Up
Menu.

3. Date Adjustment Option

This option enables you to select a European or American date for­mat. Use the yellow Ÿ Up or ź Down button to change the selection
and then press the green Ź Select button to select it.

Adjust the date in the same way as you have adjusted the time.

4. Speech Recording On/Off

Press the green Ź Select button to switch between the Speech
Recording option being on or off.

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Lifecard CF Service Manual

5. ID:Enabled/Disabled

This option enables you to give the recorder a personalised name
or number ID. Your chosen ID will appear in the Main Menu and on
reports.

To use this option, highlight the ID:Disabled line in the Set Up menu
and press on the green Ź Select button.

Press either of the yellow Ÿź buttons until ‘ID: enabled’ is displayed.

Then press the green Ź Select button to enter your recorder ID.

The Þ rst character of the ID will be highlighted. Use the yellow Ÿ ź
buttons to change the character as required and then press the green
Ź Select to move the highlight onto the next character.

You can enter a name or number up to 10 characters long.

6. Sounds On/Off

Use the green Ź Select button to select or deselect the Lifecard
sounds.

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7. Service

The recorder will remind you when the annual service is due.

3.7 Lifecard CF Sounds

The Lifecard CF generates sounds to conÞ rm your actions, or to in-
form you about the status of the recorder.

1. Click

The ‘click’ sound is emitted whenever you press the yellow Ÿ Up or
ź Down button.

2. OK ‘boing’

The ‘OK’ boing tells you that the recorder is functioning properly
and also sounds whenever you press the green Ź Select button.
The tone is a higher note than the ‘error’ tone.

3. Error tone

The Error tone tells you that the recorder has identiÞ ed an error
or warning condition. The tone is a lower note than the ‘OK’ boing.

4. High Impedance or Lead Off Alarm

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Lifecard CF Service Manual

During an extended recording, if a lead becomes detached, the
Lifecard will generate an alarm to warn the patient. The alarm is a
‘ding-dong’ tone lasting 15 seconds, and the clock display will be
replaced by the LEAD OFF message, indicating which channel has
been affected.

Once the patient has replaced the lead, the clock display resumes.

You can turn the sound off by selecting Sound Off in the set up
menu. This does not affect the ‘Lead Off’ alarm.

3.8 Error and Warnings Displays

1. You will see this error message if you are trying to use Extended
Recording Mode with a six electrode cable. Either select Start. . . for
Standard Recording Mode or change the patient cable.

2. You are trying to use Standard Recording Mode with a two elec­trode cable. Either select Start Week for Extended Recording Mode or
change the patient cable.

3. There may be a fault in the cable, or you may require a Þ rmware
upgrade to use this cable type.

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4. If this error message is displayed, contact the Service Department
at Spacelabs Healthcare Ltd.

5. This message is displayed if a patient loses a lead during an Ex­tended Recording. The Lifecard will also generate an alarm which will
consist of a series of ‘dingdong’ tones lasting 15 seconds. Once the
patient has replaced the lead, the clock display resumes.

6. This warning is generated if you have selected Start Week... and
the battery is partially discharged.

7 day recording needs a new alkaline battery.

7. You will see a warning of this format if you have selected Start

Week.... and the capacity is too small to record 7 days. Select

Continue only if the recording description meets or exceeds your
requirements.

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Lifecard CF Service Manual

8. This message appears if the card capacity and patient cable are
not appropriate to provide a 24 hour recording.

9. The Lifecard has been closed without a Flashcard inserted.
Reopen the recorder and insert the card.

10. The Flashcard has been inserted before being correctly
initialised. Remove the card and initialise the card.

11. If the Flashcard contains a recording that has not previously
been analysed, you have the option to delete it. Select the ‘DETAILS’
option - if the patient information is available, then the Patient screen
is displayed. Otherwise the screen will display just the time that the
recording was started.

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12. If the recorder detects that the rechargeable clock battery has
discharged since the last use, you must enter the time and date.

13. If this message is displayed before you start a recording, you
should insert a new battery immediately.

3.9 Decontamination

Before commencing any service or maintenance procedures, ensure
the Lifecard CF recorder has been suitably decontaminated. Unless
contamination with body ß uids is known or suspected, we recommend
low-level disinfection.

See the user instructions for further details on cleaning and
disinfecting the recorder.

In the case of severe contamination, the recorder may be beyond
repair. Please contact Spacelabs Healthcare for further advice.

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Lifecard CF Service Manual

3.10 Patient Cable

Lifecard CF patient cables use screened lead-wires with tinsel con­ductors and an antimicrophonic barrier to provide strength, ß exibility
and low noise. There is a choice of 7 patient cable units:

• 4 electrode cable with belt clip

• 4 electrode cable, short, no belt clip

• 3 electrode cable with belt clip

• 3 electrode cable, short, no belt clip

• 6 electrode cable with belt clip and renewable lead wires
(unscreened)

• 10 electrode cable for Varios Active Yoke, AHA code

• 10 electrode cable for Varios Active Yoke, IEC code

Two electrode cables for single channel ECG are no longer offered.
We recommend three electrode hook-up in long term applications.

Cables with 4 electrodes provide two channels of ECG. The popper
colour code, which is detailed on the cable, conforms to AHA (1985)
recommendations. The short cable without belt clip is designed to
maximise patient comfort when the recorder is worn under clothes.

The 3 electrode scheme and popper colour code, as detailed on the
cable label, is proprietary to Spacelabs Healthcare.

The 6 electrode cable provides three channels of ECG from 6 elec­trodes. The individual lead wires are detachable and can be replaced
with any DIN42802 connector lead wire,

useful in situations requiring unusual hook-up or electrode termina­tions. The yoke is colour coded to AHA (1985) recommendations.

The cable yoke/back unit forms a complete assembly and is not
serviceable. In the case of failure, the complete assembly must be
replaced.

In the case of the 6 electrode cable, the individual lead wires may be
replaced if broken.

The 10 electrode cable is replaceable as a complete assembly by
releasing the screw securing it to the Varios active yoke.

The Active Yoke itself it not serviceable and must be returned to Spa­celabs Healthcare for repair.

3.11 Battery

Lifecard CF requires one AAA cell, either:

Disposable cell Single AAA alkaline (Duracell MN2400 or
equivalent), two 24 hour recordings or one 48
hour recording or in Extended Recording
Modeup to 7 days, or in 12-lead mode 24
hours.

Rechargeable cell Single AAA nickel metal hydride (Ansmann
600 mAh or equivalent), one 24 hour
recording per charge, or in Extended
Recording Mode up to 3 days.
Not suitable for 12-lead recording

3.12 Battery Check

The user is warned of poor battery condition before recording, when
starting the recorder. Please refer to the detailed instructions, in this
user manual.

The real-time clock is maintained by an internal rechargeable lithium
cell, charged during recording from the main battery. With a full
charge, the clock is maintained for at least 3 months after the main
battery is removed or exhausted.

The clock cell is not replaceable by the user, and in the case of
suspected failure the Lifecard CF should be returned to Spacelabs
Healthcare for service.

Dispose of used batteries carefully, using environmentally friendly
methods wherever possible.

3.13 Checking the Hardware & Software
Revision

1. Insert a battery and close the back cover.

2. Press the Yellow (DOWN) key to highlight the About menu op­tion, then press the Green (SELECT) key.

3. The revision numbers are displayed on the LCD.

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18-0583 Rev.C

3.14 Compact Flashcard

The recorder uses a CF card (type 1) Compact Flashcard, non volatile
memory card meeting the Compact Flash Association type 1 standard.

A new ß ashcard must be conditioned before Þ rst-time use, which may
be done by the user from a menu option in the Spacelabs Healthcare
Ltd. Holter analyser. However, cards supplied by Spacelabs Health­care are already conditioned.

Full details are in the user instructions manual. If the card has not
been supplied by Spacelabs Healthcare Ltd, ensure the type is
exactly as listed in the Accessories section of this manual Other types
may give short or unreadable recordings.

Lifecard CF Service Manual

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18-0583 Rev.C

4. Test Procedure

4.1 Checking the Patient Cable

• Fit a battery and CF card to the Lifecard CF

• Connect the patient cable to the 9270 Tracker calibrator. ( For
a 3 lead cable – Red to CH1+,Yellow to CH2-, Green to CH2+,
and select Cal1, PACE 2.) If using another cable or source
ensure that there is a unique signal in each channel.

• In the main menu, select Start….

• Skip the voice recording

• Verify that the patients name has been written on the card.

• In the hook-up screen, scroll down the three channels and
check signal and quality when the cable is gently ß exed to
reveal any intermittent cable faults. Channel 2 has a negative
pacing spike only.

• When all the leads have been checked, disconnect the Lif­ecard CF and calibrator.

4.2 LC12 Varios Yoke Assembly

The Lifecard CF used to check these leads must have version V07.xx
Þ rmware. An Electromedicina ST-20 ECG Simulator is required, select
Pacemakers/DVI, test signal.

• Fit the battery and CF card to the Lifecard CF

• Connect the patient cable to the ST-20 simulator:

• Connect the Lifecard CF to the Varios yoke

• Verify that the Lifecard CF shows the Lifecard 12 splashscreen

• In the main menu, select Pacing On

• In the main menu, select Start...

• Skip the voice recording

• Verify that the patients name has been written on the card.

• In the hook-up screen, scroll down through 9 leads, checking
each one:

• All should have regular pacing markers (small vertical arrow
with P).

Lifecard CF Service Manual

37

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18-0583 Rev.C

• All should have baselines that settle in the central 1/3 of the
screen.

• The expected signals are shown in the Þ gure below.

• Checking leads I, II and III is not necessary.

• When all the leads have been checked, disconnect the Lif­ecard CF and ST-20 simulator.

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Lifecard CF Service Manual

4.3 Lifecard CF Check-out

Connect the 3 Lead Patient Cable to the 9270 Tracker Calibrator, Red
to CH1+, Yellow to CH2-, Green to CH2+, and select Cal 1, PACE 2.
If using another cable or source ensure that there is a unique signal in
each channel.

Fit a CF card, a AAA battery and the 3 Lead Patient Cable to the unit
under test. Check that the speaker tone and display are normal.
In the main menu ensure that PACING DET. Is ON, and then select
START.

Select RECORD and speak clearly into the microphone from a dis­tance of approximately 150 mm. The recording is replayed automati­cally; check that the recording / replay is clear and audible.

Select CONFIRM and then check the Channel 1, Channel 2 and
Channel 3 hook-up displays (push the ‘down’ button twice). Using the
9270 calibrator, Channel 2 has a negative pacing spike only.

Press the ‘select’ button to leave the hook-up display then select
START NOW.

Approximately 30 minutes after starting the recording press the Green
button to mark a Patient

Event in the recording. Wait for 1 minute and remove the Patient
Cable. Wait for another minute before re-attaching the Patient Cable.
After 30 seconds the Recording should continue.

Leave the recording running for up to 24 hours.

Remove the 3 Lead Patient Cable and eject the CF card, eject the
AAA battery to check for jamming.

Analyse the recording on PathÞ nder or Lifescreen. Check for the
Patient Event and recording break 30 minutes into the recording.

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18-0583 Rev.C

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Lifecard CF Service Manual

5. Spares & Part Numbers

Product Code Description

19-5000 Lithium Battery, Rechargeable

19-5044 LCF Speaker, 64 Ohms

19-5074 Microphone, Condenser

19-5075 Battery Contact, Positive

19-5077 LCD Display

19-7508 Screw PT 1.8 x 10mm, Philips

23-0223 Pocket Clip

23-0224 Mount

23-0226 Spring Pocket Clip

46-0037 Hinge Moulding

46-0043 Top Cover Moulding

46-0044 Intermediate Moulding

46-0045 Card Ejector Moulding

46-0046 Retainer Moulding, Up/Down

46-0047 Retainer Moulding, Select

46-0050 Switch Moulding, Up/Down

46-0051 Switch Moulding, Select

46-0056 PCB Insulator

46-0057 Internal Label

46-0059 Main Seal

46-0062 Top Cover Assembly

46-1570 LCF PCB Assembly, Exchange

46-0420 Mic Speaker

46-0421 Speaker Seal

46-0426 Acoustic Membrane

46-0462 Battery Contact, Negative

46-0493 Catch Moulding Printed

46-0551 Waterproof Lens

46-0418 3 Electrode Patient Cable with

Clip

46-0480 3 Electrode Patient Cable, Short

46-0556 4 Electrode Patient Cable with

Clip

46-0557 4 Electrode Patient Cable, Short

046-0031 6 Electrode Patient Cable with

Clip

19-7509 6 Electrode Wire Lead Set

046-0523 7 Electrode Patient Cable with

Clip

19-7510 7 Electrode Wire Lead Set

46-1152 LC12 Varios with 46-1123 Cable

46-1153 LC12 Varios with 46-1127 Cable

46-1122 LC12 US Patient Cable (Leads)

46-1123 LC12 EU Patient Cable (Leads)

46-1125 LC12 Varios Active Yoke (No

Leads)

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18-0583 Rev.C

6. Assembly Views

6.1 Front Assembly - Front View - Complete

Lifecard CF Service Manual

43

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18-0583 Rev.C

6.2 Front Assembly - Rear View

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Lifecard CF Service Manual

6.3 Intermediate Moulding

6.4 Circuit Board

46-0464

Batterry Contact, Negative

19-5075

Batterry Contact, Positive

19-5077

LCD Display

46-1570

LCF

PCB Assembly

46-0421

Speaker Seal,

LCF

19-5044

LCF Speaker, 64ohms

19-5074

Microphone, Condenser

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18-0583 Rev.C

Lifecard CF Service Manual

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18-0583 Rev.C

6.5 Patient Cable Mounting with Clip

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Lifecard CF Service Manual

6.6 Short Patient Cable

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18-0583 Rev.C

6.7 Varios with 46-1123 Cable 46-1152

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Lifecard CF Service Manual

6.8 Varios Lead Parts

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18-0583 Rev.C