Lifecard CF and Lifecard 12 Operations Manual Firmware Rev 8 and Higher Rev B

Consult Documents THIS SYMBOL MEANS YOU MUST READ THE ACCOMPANYING DOCUMENTS (Note: All further instances of this symbol will be represented in black & white)

“WARNING”

- Actions or circumstances that may result in personal injury or death.

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

©2017 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. Specifications and price change privileges are reserved. Spacelabs Healthcare considers itself responsible for the effects on safety, reliability and performance of the equipment only if: • assembly operations, re-adjustments, modifications or repairs are carried out by persons authorized by Spacelabs Healthcare, and • the electrical installation of the relevant room complies with the requirements 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, 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. 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 U.S.A.

Spacelabs Healthcare Ltd. Unit B, Foxholes Centre, John Tate Road, Hertford, SG13 7DT UK

Tel: +1 425 396 3300 Tel: +44 1992 507700 Fax: +1 425 396 3301 Fax: +44 1992 501213 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.

0123

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. 070-2256-01 Rev. B

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Lifecard CF & Lifecard 12 Operations Manual

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Table of Contents

1.

Introduction

1.1 1.2

About This Manual Disclaimer

2.

SAFETY AND REGULATORY

2.1 2.2 2.3 2.4 2.5 2.6 2.7 2.8 2.9 2.10 2.11 2.12 2.13

Overview Indications and Intended Use Contraindications Precautions Warnings Adverse Reactions Conformance to Standards Adjustment, Replacement of Parts, Maintenance and Repair Defects and Abnormal Stresses Modifications Decommissioning equipment Service life Product packaging

3.

LIFECARD CF OPERATING INSTRUCTIONS

3.1 3.2

Recording Procedure Flow Diagram Recording Patient Details

3.2.1. Initializing a Flashcard 3.2.2 Making a Speech Recording 3.2.3. Writing Details on the CF Card Label

3.3

3.3.1 3.3.2 3.3.3 3.3.4 3.3.5 3.5.3

3.4

1-1 1-1 2-1 2-3 2-4 2-4 2-4 2-4 2-5 2-5 2-5 2-6 2-6 2-6 2-6

3-1 3-2 3-2 3-4 3-5

Preparing the Recorder

3-5

Open the Recorder Insert the Battery Battery Capacity Battery Insert the Flashcard Six Electrode Patient Cable

3-5 3-6 3-6 3-7 3-7 3-8

Preparing the Patient

3-9

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3.4.1

Prepare the Skin

Procedures Using 3, 4 and 6 Electrode Patient Cables

3-10

3.5.1 3.5.2 3.5.3 3.5.4 3.5.5 3.5.6 3.5.7 3.5.9 3.5.11 3.5.12

Three Electrode Patient Cable Four Electrode Patient Cable Six Electrode Patient Cable Attach to the Patient Securing the Patient Cable Standard Recording Mode - The “Start” Menu Option Extended Recording Mode - The “Start Week” Menu Option Battery Requirements in Extended Mode Additional Patient Instructions for Extended Recordings Start the Recording

12-Lead Procedure Using the 10 Electrode Patient Cable

3-10 3-11 3-12 3-13 3-14 3-14 3-14 3-15 3-15 3-15

3-15

3.6.1 3.6.2 3.6.3 3.6.4 3.6.5 3.6.6 3.6.7 3.6.8

Apply the Electrodes Electrode Location & Labeling - 10 Electrode Cable Assemble the Recorder Connect the Patient Cable ECG Variation Using the Mason-Likar System Fit the Yoke Harness Secure the Lead-Wires 12-Lead Recording Behavior with Lead Off

All Procedures - Start the Recording

3-16 3-16 3-17 3-17 3-18 3-18 3-18 3-18

3-19

3.7.1 3.7.2 3.7.3 3.7.4 3.7.5 3.7.6 3.7.7 3.7.8 3.7.9

Set the Pacing detection option Select Start... or Start Week... Confirm the Patient ID Make a Speech Recording Monitor the ECG - Check the ECG Quality High Impedance or Lead-off Warning Hints for Paced Patients Check the Clock Start the Recording

Patient’s Instructions During the Recording

3-19 3-19 3-19 3-19 3-20 3-20 3-21 3-22 3-22

3-22 3-23

3.9.1 3.9.2 3.9.3 3.9.4 3.9.5

Patient Event Lead Off Alert Checking the ECG Interrupting and Re-Starting the Recording End of Recording

3-23 3-23 3-24 3-24 3-24

3.5

3.6

3.7

3.8 3.9

3.10

On the Patient’s return

3.10.1 Downloading the Recording

3.11

3.11.1 3.11.2 3.11.3 3.11.4 3.11.5

3.12

3-24 3-25

Lifecard CF Menu

3-30

Main Menu Set Up Menu Monitor Mode Recording Mode Recorder Sleep Mode

3-30 3-30 3-30 3-30 3-30

Lifecard CF Menu Options

3.12.1 Main Menu Options 3.12.2 Set Up Menu Options Lifecard CF & Lifecard 12 Operations Manual

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3-9

3-30 3-30 3-31

3.13 3.14

Lifecard CF Sounds Error and Warning Displays

3-32 3-34

4.

MAINTENANCE

4.1

Care of Flashcards

4-1

4.1.1 4.1.2

Reliability Difficulty in Reading Flashcards

Cleaning and Disinfecting Lifecard CF Recorders

4-1 4-2

4-2

4.2.1 4.2.2 4.2.3 4.2.4 4.2.5

Cleaning Lifecard CF Removing Adhesive Residues Cleaning Pouches and Lanyards Disinfecting the Lifecard CF Contamination by Body Fluids

4-3 4-3 4-3 4-3 4-3

4.2

4.3

Lifecard CF Accessories

4-4

5.

LIFECARD CF TECHNICAL MANUAL

5.1 5.2 5.3

Technical Specifications Lifecard CF Decontamination Overview of the Lifecard CF Recorder

5-1 5-4 5-4

5.3.1 5.3.2 5.3.3

Patient Cable Battery Compact Flashcard

Functional Confidence Check

5-4 5-5 5-6

5-6

5.4.1 5.4.2 5.4.3 5.4.4 5.4.5

Checking the Hardware and Software Revision Annual Service Reminder How do I find out when the next service is due? What happens when the service is due? How do I clear the Reminder Screen?

5-6 5-6 5-6 5-7 5-7

5.5.1 5.5.2 5.5.3 5.5.4 5.5.5

General Notes 5-7 Guidance and Manufacturer’s declaration – electromagnetic emissions 5-8 Guidance and manufacturer’s declaration – electromagnetic immunity 5-9 Guidance and manufacturer’s declaration – electromagnetic immunity 5-10 Recommended separation distances between portable and mobile RF communications equipment and the Lifecard CF 5-11

5.4

5.5

Electromagnetic Compatibility

5-7

6.

REFERENCE

6.1

Reference Publications

6-1

General 12-Lead Ischemia Pacing

6-1 6-1 6-1 6-1

6.1.1 6.1.2 6.1.3 6.1.4

Appendix - Signs and Symbols

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Lifecard CF & Lifecard 12 Operations Manual

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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.

1.2

•

Lifecard CF / Lifecard 12 Instruction and Technical Manual.

•

Lifecard CF Quick Guide

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.

For correct use of Lifecard, please follow the instructions in Section 3

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Lifecard CF & Lifecard 12 Operations Manual

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2. SAFETY AND REGULATORY

2.1

Overview

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.)

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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

Lifecard CF & Lifecard 12 Operations Manual

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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.

Patient Cable Varios Active Yoke

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.

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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.

2.3

Contraindications

Not intended for use with infants weighing less than 10kg. Flammable substances: The device is not intended for use in an oxygen rich environment or near a flammable anaesthetic mixture.

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. Do not sterilize the device Lifecard is not designed for use with or to be worn near an MRI machine. Remove the patient cable and all ECG electrodes before entering the machine as the electric field can cause damage to the patient. The device shall be operated only be suitably competent personnel trained in the use and procedures of Holter electrocardiography for diagnostic purposes

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. Using a defibrillator with the recorder attached to the patient will reduce the effectiveness of the defibrillator. It is recommended that the chest area is cleared first..

Lifecard CF & Lifecard 12 Operations Manual

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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. 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. Spacelabs Healthcare will make available, on request, such circuit 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 Lifecard 12 and it’s 10-electrode patient cable have defibrillator protection).

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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 defibrillation.

2.10 Modifications Do not modify this equipment without authorisation of the manufacturer 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

2.11 Decommissioning equipment Contact an authorised representative of Spacelabs Healthcare for guidance concerning decommissioning of the equipment

2.12 Service life The service life of the recorder is seven years

2.13 Product packaging It is recommended that user retain product packaging to store the unit and accessories in. If users wish to dispose of the packaging it should be done in conformance with hospital policy of the relevant local environment policy.

Lifecard CF & Lifecard 12 Operations Manual

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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. Inspect the Lifecard and its accessories for damage before use, any damaged devices should be removed from service.

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

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3.2

Recording Patient Details

There are three ways to set up the patient details. It is recommended that you do all 3 to ensure patient data is correctly identified on download and analysis. 1.

Initialize the Flashcard using the utility supplied in the Pathfinder, CardioNavigator or Impresario program, and save the patient details if known.

2.

Make a speech recording on the flashcard using the microphone on the front of the Lifecard CF, identifying the patient.

3.

Write the patient’s name or ID on the flashcard using a felt-tip marker. For best security, don’t use this method alone, but combine it with ‘1’ or ‘2’.

3.2.1.

Initializing a Flashcard

Initializing the flashcard erases the previous recording and checks the file structure. Patient details, if known, can be stored on the card at this time.

Conditioning a Flashcard Compact flashcards from Spacelabs Healthcare are supplied with the required file structure in place (conditioned), but occasionally a card may need reconditioning. If a card needs to be conditioned before use, the recorder will display this message:

The following instructions will condition the card if required, and will delete any files that are on the card. 1.

Insert the flashcard into the flashcard reader, ensuring the correct orientation of the card.

The next step will depend upon which type of analyzer you are using. Select 2a, b, c, d, or e as appropriate.

You may be using: •

Pathfinder or Lifescreen with the CardioNavigator database (see 2a)

•

Pathfinder or Lifescreen with the Report Manager (Archive Maintenance) database (see 2b/2c)

•

Impresario (see 2d).

•

Sentinel (see 2e)

Follow the appropriate instructions below, according to the system you have. Lifecard CF & Lifecard 12 Operations Manual

3-2

2a.

Using CardioNavigator 1.

Click on the Patient menu and select the New Patient option or click on the New Patient icon

2.

Enter the details in the New Patient dialog box and when complete, click on OK.

3.

Highlight the patient in the Patient List and with the flashcard inserted into the reader, click on the Lifecard CF Configure icon. The patient details will then be transferred to the card.

2b.

Using Pathfinder with Report Manager 1.

In the Pathfinder Utilities menu, select the Initialize Compact Flash option.

2.

In the dialogue box displayed, you can enter the patient’s name and ID. Click the Initialize CF button to store the details on the card and to prepare the card for a new recording.

2c.

Using Lifescreen If your Lifescreen program is using the CardioNavigator database, click on the File menu and then select CardioNavigator and follow the above procedure “2a”. If your Lifescreen program is using the Report Manager database, use the “Initialize Lifecard CF” desktop shortcut. This displays the same entry dialog as shown in “2b”.

2d.

Using Impresario 1.

Open the Impresario application by double clicking on the desktop icon.

2.

Enter the patient details or if the details are already in the database, select the patient from the patient list that appears upon selecting the Browse button [...]

3.

Click on the Initialize Lifecard button.

4.

A message will show when initialization is complete.

2e

The Acquire tab should be highlighted.

Using Sentinel V8 or 9 1.

From the Sentinel Home Page click Holter.

2.

The Holter Worklist page opens. Click Configure. Sentinel will now scan for all connected Holter recorders or Compact Flash cards and will display these in a list to the left of the screen.

3.

Select the Lifecard CF.

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4.

Click the Configure button.

5.

Enter the patients name or ID that is to be associated with the test in the Find text box.

6.

If the correct record is shown in the search results, double click on the required record or click once on the record and then click on the Select Patient button.

7.

If the desired record is not shown, click on Add New Patient and input the patients details.

8.

You may at this time edit the test details by clicking on the Edit Test button and making the desired changes. (See Sentinel user manual for further details).

9.

Click Save when finished.

10. To configure the recorder or Compact Flash card click on Start Configure. 11. Click OK in the successful configuration box. 12. You will now be presented with the Holter Worklist Screen.

2f Using Sentinel 10 From the HOME screen, select the Holter Module from the Function Bar 1.

Ensure a Holter recorder is connected to your PC, click on Configure recorder for patient

2.

The Configure Holter recorder work screen opens

3.

Enter search criteria, when the patient is found, highlight and select patient from search results.

4.

Click on Use selected patient.

5.

If the patient is not found, click on Add patient to create a new patient then select Save patient and configure Holter.

6.

Sentinel will search for a connected recorder

7.

Configuration window will open; click Configure to continue. Confirm the patient details and select Configure.

If configuration is successful no further message will be displayed, the test status will now be displayed as Configured

3.2.2

Making a Speech Recording

A Speech Recording is made by the user, following the normal procedure to prepare the recorder and start the recording. The speech recording can be any message that will identify the patient later when the Lifecard CF & Lifecard 12 Operations Manual

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