evo Recorder and Docking Station Instruction and Technical Manual Rev B

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Contents 1.

2.

3.

4.

Page

INTRODUCTION

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1.1 1.2

About this Manual Disclaimer

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SAFETY AND REGULATORY

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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 2.14

7 9 10 10 10 10 10 11 11 11 12 12 12 13

Device Description Indications and Intended Use Contraindications Precautions Warning Adverse Reactions Caution Conformance to Standards Adjustment, Replacement of Parts, Maintenance & Repair Defects and Abnormal Stresses Modifications Declaration of Conformity Explanation of Markings Manufacturer

DETAILED OPERATING INSTRUCTIONS

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3.1 3.2 3.3 3.4 3.5 3.6 3.7 3.8 3.9 3.10 3.11 3.12 3.13

15 15 15 16 16 18 19 20 22 23 24 25 26

First-time Use Minimum Software Versions Manual Recording Identification Recording Procedure Overview Prepare the Recorder Prepare the Patient Apply the Electrodes Hook up the Recorder Check the ECG Quality Instruct the Patient On the Patient’s Return Download the Recording Analyse the Recording

MAINTENANCE

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4.1 4.2 4.3

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Cleaning and Disinfecting the evo Recorder Dynamic Energy Source Replacement Kit evo Recorder Accessories and Consumables

Instruction and Technical Manual

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5.

6.

TECHNICAL MANUAL

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5.1 5.2 5.3 5.4 5.5 5.6 5.7 5.8 5.9

31 33 34 34 34 34 35 35 36

evo Recorder Technical Specifications evo Docking Station Technical Specifications evo Error Messages Software Error Messages and Warnings Firmware Update Utility Installation of the Docking Station Infrared Data Transfer User Labelling of the Recorder User labelling of the docking station

INDEX

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Copyright 2008 Spacelabs Healthcare Ltd. 1 Harforde Court, John Tate Road, Hertford SG13 7NW 4

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1.

INTRODUCTION

1.1 About this Manual This manual contains detailed operating instructions for the evo Holter ECG recorder and the evo docking station. It is one of 3 manuals for this recorder. •

evo Recorder Instruction and Technical Manual

•

evo Recorder Quick Guide – Sentinel Users

•

evo Recorder Quick Guide – CardioNavigator Plus

This manual has 6 chapters: Chapter 1

Introduction

Chapter 2

Safety and Regulatory

Chapter 3

Detailed Operating Instructions

Chapter 4

Maintenance

Chapter 5

Technical Manual

Chapter 6

Index

1.2 Disclaimer Every effort has been taken to ensure the accuracy of this manual but Spacelabs Healthcare cannot take 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.

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2.

SAFETY AND REGULATORY

2.1 Device Description The evo recorder is a compact, lightweight three channel Holter Ambulatory ECG recorder utilizing a digital storage technique to store the ECG recording onto an internal flash memory. This recorder provides continuous monitoring of 3 leads of ECG for 24 hours or 48 hours. The on board display allows the user to monitor the ECG and pacing detection during hook-up. Pacing detection is always enabled on all 3 channels. It is important to verify the ECG quality before starting the recording. Menu navigation is controlled by the single button on the front of the recorder. This button also acts as a Patient Event button when Recording Mode is active. This enables the patient to indicate symptomatic episodes in the recording for correlation with the Patient Diary. Four separate lead wires with color coded snap leads are used to connect the electrodes on the chest to the recorder. The internal Dynamic Energy Source is automatically re-energized when each recording is downloaded into the Holter Analyser via the docking station. Recordings may be analyzed using an Impresario Holter analyzer in conjunction with the Sentinel Cardiology Information Management software. The recorder is also compatible with the CardioNavigator Plus database used in conjunction with Impresario scanners.

evo Front View

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evo Top View

evo Rear View

Docking Station Rear View

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evo placed in Docking Station

2.2 Indications and Intended Use The evo Holter recorder is to be used for the non-invasive ambulatory recording of three channel electrocardiograms on an internal, non removable flash memory. The recorder allows data to be collected over a continuous period of up to 48 hours while allowing the subject to perform most of their normal daily activities. No analysis is performed by the evo recorder; the recordings can be analyzed on compatible Holter analysis systems from Spacelabs Healthcare 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 only be operated by suitably competent personnel trained in the use and procedures of Holter electrocardiography for diagnostic purposes.

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2.3 Contraindications None known.

2.4 Precautions Follow the cleaning instructions for reasons of basic hygiene and to reduce the risk of cross-infection. The evo recorder is not intended for use on infants weighing less than 10 Kg. Under normal operating conditions, the recorder may feel slightly warm upon removal from the docking station. During patient hook-up, ensure that the electrodes do not come into contact with other metal parts or ground.

2.5 Warning 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 evo recorder while it is connected to a subject.

2.6 Adverse Reactions Patients may suffer allergic skin reactions from the adhesive of the electrodes, causing reddening, soreness or irritation. Ask the patient if they suffer from these allergies. Contact the electrode provider for further specific information.

2.7 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.

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2.8 Conformance to Standards According to ANSI/AAMI EC38:1998, the evo recorder is a Type 1 ambulatory ECG device. 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.

2.

EQUIPMENT having a TYPE BF APPLIED PART.

3.

ORDINARY EQUIPMENT, without protection against ingress of liquid.

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.

2.9 Adjustment, Replacement of Parts, Maintenance & Repair The device requires no routine adjustments to maintain its operation. The device contains one user serviceable part. 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 warranty. Only use the docking station mains adapter supplied by Spacelabs Healthcare. Use of the wrong adapter may damage the docking station.

2.10 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. The evo recorder contains protection against electrostatic discharge, but there is no protection against defibrillators. To avoid damage the device should be removed before defibrillating.

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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.

2.11 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.

2.12 Declaration of Conformity This product is in conformity with the essential requirements and provisions of Council Directive 93/42/EEC concerning medical de vices.

2.13 Explanation of Markings CE MARK

Year of Manufacture Consult Documents THIS SYMBOL MEANS YOU SHOULD READ THE ACCOMPANYING DOCUMENTS EQUIPMENT having a TYPE BF APPLIED PART If you wish to dispose of this equipment, it must not be disposed of together with ordinary waste but either returned to the manufacturer or to a specialised collection system for used electrical and electronic products

AECG TYPE 1

TYPE 1 AMBULATORY ECG DEVICE ACCORDING TO ANSI/AAMI EC38:1998. 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.

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2.14 Manufacturer Manufactured for: Spacelabs Healthcare Limited 1 Harforde Court John Tate Road Hertford, Herts. SG13 7NW United Kingdom Tel: + 44 (0) 1992 507700 Fax:+ 44 (0) 1992 501213

Distributed by: Spacelabs Healthcare Inc. 5150 220th Avenue SE Issaquah, Washington 98027 United States. Tel: Fax:

(425) 657-7200 (425) 657-7212

Web site: www.spacelabshealthcare.com

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3.

DETAILED OPERATING INSTRUCTIONS

This chapter of the manual provides detailed operating instructions for the evo recorder and the docking station. To help you get started, refer to the separate evo Quick Guides. You may also need to refer to the Sentinel / CardioNavigator Plus Instruction Manuals.

3.1 First-time Use The evo is ready to use ‘out the box’ with the Dynamic Energy Source energized for a full 48hour recording.

3.2 Minimum Software Versions If you are using the Sentinel Data Management software, you must ensure that the software version is V6.0.2.188 or greater. If you are using the CardioNavigator Plus database, the software version must be V3.05. or greater.

3.3 Manual Recording Identification If interface with an evo programmer is not available, there is a location for a user label on the back of the recorder. Write the name of the patient on the label and attach the label to the back of the recorder. Note that a suitable pen and a pack of user labels are included with your recorder. A 70% alcohol wipe may be used to erase writing from the label. Please see section 5.8 of this manual for further details. The recorder stores the date and start time of the recording, together with the serial number of the recorder. If a label is not available, simply note down the recorder serial number (shown on the back of the recorder), date and start time of the recording, together with the patient’s name in a suitable log book.

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3.4 Recording Procedure Overview Step

Description

3.4

Prepare the recorder

3.5

Prepare the patient

3.6

Apply the electrodes

3.7

Hook up the recorder

3.8

Check the ECG quality and start recording

3.9

Instruct the patient

3.10

On the patient’s return, end the recording

3.11

Download the recording

3.12

Analyze the recording

Prepare the recorder Prepare the patient Apply the electrodes Hook up the recorder Check the ECG quality and start recording Instruct the patient On the patients return, end the recording Download the recording Analyze the recording

3.5 Prepare the Recorder When the recorder is not in use, the recorder screen will be blank. The recorder is then in ‘Sleep mode’. 1.

Press the menu navigation button briefly; the recorder will perform a self test.

If a Patient ID is displayed, the recorder has already been configured for a specific patient. Go to Page 17. No Patient ID is shown, there is no patient ID information stored in the recorder. Follow the instructions shown below. The recorder will indicate the time, date and recording length. This screen indicates that there is no patient ID or ECG data in the recorder. You may proceed directly to Section 3.6, Prepare the Patient, but it is highly recommended that you load the patient details (configure the recorder) via the docking station as shown in the next step. 2.

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Place the recorder in the docking station. (The green LED will light). The configuration procedure depends upon the database that you are using, Sentinel or CardioNavigator Plus. Instructions are given in the relevant user manual. 50-0037 Rev B

Configuration Procedure for Sentinel Users Please see the Sentinel User Manual for details.

Configuration Procedure for CNAV+ Systems 1.

With the recorder in the docking station, click on the desktop icon.

2.

The Evo Configuration screen will open. Enter in the patient details, select the recording length, then click on Config.

Note that if the evo clock is not a the current system time, a message will inform you that the clock in the recorder will be synchronised with the PC. Once configuration is complete, the Configuration complete message will appear. The Recorder details will then appear inside the evo configuration screen at the right hand side.

3.

Remove the recorder from the dock when the OK TO REMOVE message appears on the recorder screen.

Now go to Section 3.6, Prepare the Patient.

" From page 15. The recorder has already been prepared for the next scheduled test. Check that this patient name is correct and press the ►Confirm button to continue. Instruction and Technical Manual

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When the recorder is removed from the docking station, the recorder screen is cleared and the amber LED on the docking station will be illuminated. You should now prepare the patient and hook up the recorder. Note that you may delete the patient details at this stage if they are not correct by pressing on the ◄Delete button. You will be asked to confirm your decision. You should then configure the recorder with the correct patient details.

3.6 Prepare the Patient •

Proper preparation of the electrode sites and accurate placement of the electrodes are two crucial steps for successful ECG data recording and analysis.

•

Success of Holter analysis depends largely on the quality of the recording.

•

The recording quality is significantly reduced by artifact, which is caused by improper skin preparation and improper placement of the electrodes.

•

Carefully following the steps in this section for preparing all patients will help in obtaining the best recording by reducing artifact.

Prepare the skin Shave Hair

Clean skin with alcohol wipe*

Gently abrade the skin

" Use good quality electrodes for the final hook-up. We recommend Ambu Blue Sensor types VL-00-S for 24 hour recordings, and VLC-00-S for 48 hour recordings. * a saline wipe may be used if so wished.

Apply the electrodes The electrode positions shown on the following pages are suggested but not mandatory. You may find alternative positions more suitable on individual patients.

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Standard Hookup

Place all electrodes directly over bone to reduce muscle artifact. Channel

Color (Polarity)

Location

Common

White (neg.)

Center of manubrium

Ch. 1 Modified CM–V5

Red (pos.)

Left anterior axillary line, 6th rib

Ch. 2 Modified CM–V1

Brown (pos.)

Two centimeters right of the xiphoid process on the rib

Ch. 3 Modified CM–V3

Orange (pos.)

Left mid-clavicular line, 6th rib

3.7 Apply the Electrodes After you have prepared the electrode sites, remove the electrodes from the package and apply the electrodes as described in the following procedure. NOTE Use only silver/silver-chloride electrodes that are suitable for Holter recording. 1.

Connect a color-coded, snap-lead wire to an electrode.

2.

Remove the adhesive backing of the electrode at the pre-cut separation (located behind the electrode near the gel).

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3.

Apply the electrode to the prepared site.

4.

Smooth the adhesive disk outward, and press it firmly around the edges to ensure good adhesion to the skin.

NOTE Do not press in the middle of the electrode, because doing so will squeeze out the gel.

3.8 Hook up the Recorder The evo recorder is either suspended from the patient’s neck using a chest-pouch or attached to the patient’s belt using the belt mounted pouch option.

Chest-pouch To attach the recorder to the patient using the chest-pouch, perform the following steps:

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1.

Open the plastic clip on the recorder pouch.

2.

Feed the free strap end through the clip.

3.

Adjust to the correct length for the patient and press the clip closed. The strap may be cut to the correct length once the clip is fastened.

4.

You may fix the lower end of the pouch using a Skin Fix if so wished. (Optional)

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