Spacelabs Healthcare Lifecard CF, Lifecard 12 User manual

Service Manual

Lifecard CF

and

Lifecard 12

Firmware revision 7

18-0583 Rev. C

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Contents Page

1.	PRODUCT OVERVIEW		7
1.1	INTRODUCTION		7
1.2	SpeciÞcation		9
1.2.1		Standard Recording Mode – ECG Inputs	9

1.2.2Standard 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 SpeciÞcations 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 ClassiÞcation		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

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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

4	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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1. PRODUCT OVERVIEW

1.1Introduction

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 PathÞnder, 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

Recorder Unit

Lifecard CF

Display

Yellow Button	Green Button
Menu Navigation	Menu
and	Selection
Patient Event	and
	Patient Event

Microphone

Loudspeaker

Patient Cable Unit

Patient Cable

Electrode Color

Code label

Belt Clip (long cables only)

Slot for Neck

Lanyard

Attachment

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Patient Cable

Varios Active Yoke

1.2Specifi cation

1.2.1Standard 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 Þlter effective from 60Hz to
	> 1MHz, 128 samples per second out
	put rate

1.2.2Standard 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

1.2.3Standard 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
	(PathÞnder systems), Encrypted patient record
	Þle (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 identiÞcation
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 identiÞcation

1.2.5Power 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

1.2.6Extended 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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1.2.7Additional Specifi cations in 12-Lead Mode

Channels	Standard 12-lead, one neutral and nine active
	electrodes
Cable types	10 electrode, deÞbrillation 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

1.2.8Physical and Environmental

Dimensions	96 x 57 x 17.5mm with patient cable Þtted
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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1.2.9Electro-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 speciÞcations 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 Þnd 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 OfÞce, Washington, DC 20402, Stock No. 004-000-00345-4.

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2. SAFETY AND REGULATORY

2.1Intended 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 ßash card.

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

2.2Safety 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 ßammable anesthetic mixture with air or with oxygen or nitrous oxide, or ßammable cleaning agents.

6.Rated for CONTINUOUS OPERATION.

7.EQUIPMENT with an APPLIED PART, speciÞcally 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.

2.3Adjustment, 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.

2.4Defects and abnormal stresses

For continued safety the device must not be maltreated, used outside its speciÞed operation conditions, or stored outside its speciÞed storage conditions.

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

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