Spacelabs Healthcare Lifecard CF User manual

1
ИНСТИТУТ ЗА КАРДИОВАСКУЛАРНЕ
БОЛЕСТИ ВОЈВОДИНЕ, СРЕМСКА КАМЕНИЦА
Пут доктора Голдмана 4, 21204 Сремска Каменица
РЕПУБЛИКА СРБИЈА
Тел: [phone]; Фаx: 021/66 22 881
Ред.бр.ЈН-МВ-07/19
Бр. 3742 - 7
Датум: 26.12.2019.
ПРЕДМЕТ: Додатно појашњење увези са припремањем понуда за јавну
набавку бр. ЈН-МВ-07/19 –Батерије и акумулатори
Дана 25.12.2019. године електронским путем нам је достављен допис
заинтересованог лица којим се тражи додатно појашњење увези са припремањем понуде за
јавну набавку ЈН-МВ-07/19 –Батерије и акумулатори, уоквиру којег је тражено следеће
појашњење:
“Собзиром да је батерија AAA LR03 намењена за свакодневни рад холтер апарата, молимо
Вас за информацију оминималним техничким карактеристикама упогледу унутрашњег
отпора иживотног века батерије.”
На основу члана 63. став 3. Закона ојавним набавкама („Службени гласник
РС“ бр. 124/2012, бр. 14/15 и68/15), достављамо појашњење:
У упуству произвођача за холтер апарат Lifecard CF се не захтевају минималне
техничке карактеристике у погледу унутрашњег отпора и животног века батерије.
У упуству произвођача за холтер апарат Lifecard CF се за батерију захтева alkalna baterija
Duracell MN2400 или одговарајућа.
На страни 3-6 тачка 3.3.3 упуства произвођача за холтер апарат Lifecard CF детаљно се
наводи захтевани батеријски капацитет или еквивалент. Такође под тачком 3.3.4 се наводи
упозорење произвођача, ако корисник холтер уређаја користи батерије које нису препорука
произвођача може доћи до оштећења уређаја Lifecard CF тј. батеријских контаката или може
угрозити дужину снимања података пацијента.
Сходно наведеном, потребно је да понуђено добро буде одговарајуће алкалној
батерији Duracell MN2400.
Наручилац прилаже уз додатно појашњење упуство за употребу произвођача за
холтер апарат Lifecard CF.
Ова информација, сходно члану 63. став 3. Закона ојавним набавкама, се објављује
на Порталу јавних набавки иинтернет страници Наручиоца.
Комисија за јавну набавку

Lifecard CF & Lifecard 12
Firmware Rev7
070-2256-00 Rev. C | www.spacelabshealthcare.com
OPERATIONS MANUAL

Consult Documents
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ACCOMPANYING DOCUMENTS
(Note: All further instances of this symbol will be represented
in black & white)

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070-2256-00 Rev C
©2013 Spacelabs Healthcare Ltd.
All rights reserved. Contents of this publication may not be reproduced in any form
without the written permission of Spacelabs Healthcare. Products of Spacelabs
Healthcare are covered by U.S. and foreign patents and/or pending patents. Specifi-
cations and price change privileges are reserved.
Spacelabs Healthcare considers itself responsible for the eects on safety, reliability
and performance of the equipment only if:
• assembly operations, re-adjustments, modifications or repairs are car-
ried out by persons authorized by Spacelabs Healthcare, and
• the electrical installation of the relevant room complies with the re-
quirements of the standard in force, and
• the equipment is used in accordance with the operations manual.
Spacelabs Healthcare will make available, on request, such circuit diagrams, compo-
nent part lists, descriptions, calibration instructions or other information which will
assist appropriately qualified technical personnel to repair those parts of the equip-
ment which are classified by Spacelabs Healthcare as field repairable.
Spacelabs Healthcare is committed to providing comprehensive customer support
beginning with your initial inquiry through purchase, training, and service for the life
of your Spacelabs Healthcare equipment.
CORPORATE OFFICES
Spacelabs Healthcare Inc
35301 SE Center Street
Snoqualmie, WA 98065
USA
Tel: [phone]
Fax: [phone]
Spacelabs Healthcare Ltd.
1 Harforde Court,
John Tate Road
Hertford. SG13 7NW
UK
Tel: [phone]
Fax: [phone]
Brands and product names are trademarks of their respective owners.
Caution:
Federal (USA) law restricts this device to sale by or on the order
of a medical practitioner licensed by the law of the state in which
he practices to use or order the use of the device.
CE marked in accordance with the Medical Device Directive,
93/42/EEC
Security-related information is indicated in the following manner in this manual:.
“WARNING” - Actions or circumstances that may result in personal injury or
death.
“ATTENTION” - Actions or circumstances that could damage the equipment,
produce inaccurate data, or invalidate a procedure.
“NOTE” - Useful information to a product feature, function, or procedure.

Lifecard CF & Lifecard 12 Operations Manual
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070-2256-00 Rev C
1. Introduction
1.1 About This Manual 1-1
1.2 Disclaimer 1-1
2. SAFETY AND REGULATORY
2.2 Indications and Intended Use 2-3
2.3 Contraindications 2-4
2.4 Precautions 2-4
2.5 Warnings 2-4
2.6 Adverse Reactions 2-4
2.7 Conformance to Standards 2-4
2.8 Adjustment, Replacement of Parts, Maintenance and
Repair 2-5
2.9 Defects and Abnormal Stresses 2-5
2.10 Modifications 2-6
2.11 Declaration of Conformity 2-6
2.12 Warranty 2-6
3. LIFECARD CF OPERATING
INSTRUCTIONS
3.1 Recording Procedure Flow Diagram 3-1
3.2 Recording Patient Details 3-2
3.2.1. Initializing a Flashcard 3-2
3.2.2. Making a Speech Recording 3-4
3.2.3. Writing Details on the CF Card Label 3-4
3.3 Preparing the Recorder 3-5
3.3.1 Open the Recorder 3-5
3.3.2 Insert the Battery 3-6
3.3.3 Battery Capacity 3-6
3.3.4 Warning! 3-6
3.3.5 Insert the Flashcard 3-7
3.4 Preparing the Patient 3-8
3.4.1 Prepare the Skin 3-8
Table of Contents

Lifecard CF & Lifecard 12 Operations Manual
vi
3.5 Procedures Using 3, 4 and 6 Electrode Patient Cables 2-1
3.5.1 Three Electrode Patient Cable 2-1
3.5.4 Attach to the Patient 3-1
3.5.5 Securing the Patient Cable 3-2
3.5.6 Standard Recording Mode - The “Start” Menu
Option 3-2
3.5.7 Extended Recording Mode - The “Start Week” Menu
Option 3-3
3.5.8 Lead Off Alarm in Extended Mode 3-3
3.5.9 Battery Requirements in Extended Mode 3-3
3.5.10 Electrodes for Extended Recordings 3-3
3.5.11 Additional Patient Instructions for Extended
Recordings 3-4
3.5.12 Start the Recording 3-4
3.6 12-Lead Procedure Using the 10 Electrode Patient
Cable 3-4
3.6.1 Apply the Electrodes 3-5
3.6.2 Electrode Location and Labeling When Using the
10 Electrode Patient Cable 3-5
3.6.3 Assemble the Recorder 3-6
3.6.4 Connect the Patient Cable 3-6
3.6.5 ECG Variation Using the Mason-Likar System 3-6
3.6.6 Fit the Yoke Harness 3-6
3.6.7 Secure the Lead-Wires 3-7
3.6.8 12-Lead Recording Behavior with Lead Off 3-7
3.7 All Procedures- Start the Recording 3-7
3.7.1 Set the Pacing detection option 3-7
3.7.2 Select Start... or Start Week... 3-8
3.7.3 Confirm the Patient ID 3-8
3.7.4 Make a Speech Recording 3-8
3.7.5 Monitor the ECG - Check the ECG Quality 3-8
3.7.6 High Impedance or Lead-off Warning 3-10
3.7.7 Hints for Paced Patients 3-10
3.7.8 Check the Clock 3-11
3.7.9 Start the Recording 3-11
3.8 Patient’s Instructions 3-11
3.9 During the Recording 3-12
3.9.1 Patient Event 3-12
3.9.2 Lead Off Alarm 3-12
3.9.3 Checking the ECG 3-13
3.9.4 Interrupting and Re-Starting the Recording 3-13
3.9.5 End of Recording 3-13
3.10 On the Patient’s return 3-13
3.10.1 Downloading the Recording 3-14
3.11 Lifecard CF Menu 3-17
3.11.1 Main Menu 3-17

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070-2256-00 Rev C
3.11.2 Set Up Menu 3-18
3.11.3 Monitor Mode 3-18
3.11.4 Recording Mode 3-18
3.11.5 Recorder Sleep Mode 3-18
3.12 Lifecard CF Menu Options 3-18
3.12.1 Main Menu Options 3-18
3.12.2 Set Up Menu Options 3-19
3.13 Lifecard CF Sounds 3-20
3.14 Error and Warning Displays 3-21
4. MAINTENANCE
4.1 Care of Flashcards 4-1
4.1.1 Reliability 4-1
4.1.2 Difficulty in Reading Flashcards 4-2
4.2 Cleaning and Disinfecting Lifecard CF Recorders 4-2
4.2.1 Cleaning Lifecard CF 4-3
4.2.2 Removing Adhesive Residues 4-3
4.2.3 Cleaning Pouches and Lanyards 4-3
4.2.4 Disinfecting the Lifecard CF 4-3
4.2.5 Contamination by Body Fluids 4-3
4.3 Lifecard CF Accessories 4-4
5. LIFECARD CF TECHNICAL MANUAL
5.1 Technical Specifications Lifecard CF 5-1
5.2 Decontamination 5-4
5.3 Overview of the Lifecard CF Recorder 5-4
5.3.1 Patient Cable 5-4
5.3.2 Battery 5-5
5.3.3 Compact Flashcard 5-6
5.4 Functional Confidence Check 5-6
5.4.1 Checking the Hardware and Software Revision 5-6
5.4.2 Annual Service Reminder 5-6
5.4.3 How do I find out when the next service is due? 5-7
5.4.4 What happens when the service is due? 5-7
5.4.5 How do I clear the Reminder Screen? 5-7
5.5 Electromagnetic Compatibility 5-7
5.5.1 General Notes 5-7
5.5.2 Guidance and Manufacturer’s declaration –
electromagnetic emissions 5-8
5.5.3 Guidance and manufacturer’s declaration –
electromagnetic immunity 5-10
5.5.4 Guidance and manufacturer’s declaration –
electromagnetic immunity 5-11
5.5.5 Recommended separation distances between portable
and mobile RF communications equipment and the
Lifecard CF 5-12

Lifecard CF & Lifecard 12 Operations Manual
viii
6. REFERENCE
6.1 Reference Publications 6-1
6.1.1 General 6-1
6.1.2 12-Lead 6-1
6.1.3 Ischemia 6-1
6.1.4 Pacing 6-1
Appendix - Signs and Symbols

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070-2256-00 Rev C
1. Introduction
1.1 About This Manual
This manual contains detailed operating instructions for the Lifecard CF recorder
and the 12-lead Lifecard 12 option. It is one of two manuals for this recorder.
• Lifecard CF / Lifecard 12 Instruction and Technical Manual.
• Lifecard CF Quick Guide
1.2 Disclaimer
Every effort has been taken to ensure the accuracy of this manual but Spacelabs
Healthcare cannot accept liability for consequences caused by errors or omissions.
You are advised to check with Spacelabs Healthcare on any point on which you are
unsure or need confirmation.
All images within this manual are intended for illustration purposes only and may
differ slightly from the actual product.

Lifecard CF & Lifecard 12 Operations Manual
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070-2256-00 Rev C
2. SAFETY AND REGULATORY
The Lifecard CF is a compact Holter Ambulatory ECG Recorder utilizing 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 two buttons on the front of the
recorder unit.
The Lifecard CF recorder requires one AAA (LR03) 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 analyzed using a Spacelabs Healthcare Pathfinder, Pathfinder SL
Impresario, or Lifescreen Holter analysis system, if they have compatible hardware
and software. (Lifescreen is incompatible with 12-lead recordings.)

Lifecard CF & Lifecard 12 Operations Manual
2-2
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

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070-2256-00 Rev C
The Lifecard CF comprises two sections; the ‘Recorder Unit’ and the ‘Patient Cable
Unit’.
The 12-lead option has a two-part cable unit comprising the ‘Varios’ Active Yoke unit
and the 10 electrode patient cable. The Lifecard CF recorder remains as shown on
the previous page.
Note Do not attempt to remove the patient cable from the yoke, unless
replacing a broken cable
2.2 Indications and Intended Use
The Lifecard CF Holter recorder is to be used for the non-invasive ambulatory
recording of two or three channel electrocardiograms on an approved compact flash
card.
The Lifecard 12 option is to be used for the non-invasive ambulatory recording of
12-lead electrocardiograms on an approved compact flash 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 analyzed on compatible analysis systems from Spacelabs
Healthcare.
Patient Cable
Varios Active Yoke

Lifecard CF & Lifecard 12 Operations Manual
2-4
This device has been designed and supplied specifically 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.
2.3 Contraindications
Not intended for use with infants weighing less than 10kg.
2.4 Precautions
Follow the cleaning instructions for reasons of basic hygiene and to reduce the risk
of cross-infection.
Medical electrical equipment needs special precautions regarding electromagnetic
compatibility (EMC). The Lifecard CF should be used in accordance with the EMC
guidance given in section 5.5 of this manual.
2.5 Warnings
This device must not be used for direct cardiac application.
Never attempt to connect any other device or instrument to the internal connections
or circuitry of the Lifecard CF while it is connected to a patient. Electrodes and their
associated connectors should not be allowed to contact other conductive parts even
if they are at ground potential.
This device is not suitable for use in wet environments.
2.6 Adverse Reactions
Patients may suffer allergic skin reactions from the adhesive electrodes, causing
reddening, soreness or irritation. Ask the patient if they suffer from these allergies.
Contact the electrode manufacturer for further specific information.
2.7 Conformance to Standards
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.
2. EQUIPMENT having a TYPE BF APPLIED PART.

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070-2256-00 Rev C
or
3. EQUIPMENT having a TYPE CF APPLIED PART if so marked.
4. Not suitable for use in the presence of a flammable anaesthetic mixture
with air or with oxygen or nitrous oxide, or flammable cleaning agents.
5. Rated for CONTINUOUS OPERATION.
6. EQUIPMENT with an APPLIED PART, specifically 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.
2.8 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.
Unauthorized repairs or dismantling of the device will invalidate the guarantee.
SpacelabsHealthcare will makeavailable,on request, suchcircuit diagrams,component
part lists, descriptions, calibration instructions or other information which will assist
appropriately qualified technical personnel to repair those parts of the equipment
which are classified by Spacelabs Healthcare as field repairable.
2.9 Defects and Abnormal Stresses
For continued safety the device must not be maltreated, used outside its specified
operation conditions, or stored outside its specified storage conditions.
Lifecard CF contains protection against electrostatic discharge, but there is no
protection against defibrillators. To avoid damage the device should be removed
before defibrillating. (The 10-electrode patient cable has defibrillator protection).
Whenever it is likely that protection has been impaired, the device shall be made
inoperative and secured against any unintended operation. The protection is likely to
be impaired if, for example, the device :-
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 defibrilla-
tion.

Lifecard CF & Lifecard 12 Operations Manual
2-6
2.10 Modifications
For continued safety, the device shall not be subjected to any unauthorized
modifications and must be used only for the purpose for which it was originally
supplied.
2.11 Declaration of Conformity
This product is in conformity with the essential requirements and
provisions of Council Directive 93/42/EEC concerning medical
devices.
2.12 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 benefit 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 notified 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 notified
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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070-2256-00 Rev C
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 profit 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.

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070-2256-00 Rev C
3. LIFECARD CF OPERATING
INSTRUCTIONS
This chapter of the manual provides detailed operating instructions for the Lifecard
CF recorder. To help you get started, refer to the separate Quick Guide.
3.1 Recording Procedure Flow Diagram
Prepare the flashcard with patient details

Prepare the recorder

Prepare the patient

Apply electrodes and hook-up

Attach the recorder

Start the recording

Check the ECG quality

Instruct the patient

After recording, remove and clean the recorder

Download the recording