Spacelabs Healthcare Lifecard CF, Lifecard 12 User manual
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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’.
Lifecard CF Service Manual
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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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18-0583 Rev.C
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.
Lifecard CF Service Manual
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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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