WelchAllyn Schiller MT100 Instruction Booklet First Issue a Jan 2000

MT-100

Holter Recorder / Enregistreur Holter

Operating Instruction Booklet - Manuel d'Utilisateur

MT-100 User's Guide - Manuel d'Utilisateur 2. 510 106a First Issue/Première Edition (a):

Januar 2000 - bi-lingual version (EF)

Associated Documents

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Guide to the WELCH ALLYN Measurement and Interpretation Programs (Physicians Guide) E Article N° 2. 510 179wa MT-200 User's Guide - English Article N° 2. 510 107

MT-100

Holter Recorder / Enregistreur Holter

Operating Instruction Booklet - Manuel d'Utilisateur

DECLARATION OF CONFORMITY

PC-Based Arrhythmia, Detection and Evaluation Program

MT-100

Serial numbers starting with:

273.

Years of manufacturing:

1997 onwards

We, the undersigned, hereby declare that the medical device (class II a) specified above conforms with the Essential Requirements listed in Annex I, of EC Directive 93/42/EEC This declaration is supported by: Certificate of approval No: 11425-02 45112-60-01 and 45112-16-01

ISO 9001 / EN 46001 by SQS valid date 17. January 2001 ISO 9001/ 07.94, EN 46001 / 08.96 by DEKRA valid date 30.04.200 Annex II, Section 3 of the Directive 93/42/EEC, valid date 30.04.2003

Baar (Switzerland) 09.06.1998

J.J. Schmid Research & Development Manager

WA MT-100 Instruction Booklet. Article No. 2. 510 108. Copyright © 1997 - 1999 by SCHILLER AG

Markus Bütler Quality Assurance Manager

MT-100

Holter Recorder / Enregistreur Holter

Operating Instruction Booklet - Manuel d'Utilisateur

Disclaimer The Information in this guide has been carefully checked for reliability; however no guarantee is given as to the correctness of the contents and WELCH ALLYN SCHILLER makes no representations or warranties regarding the contents of this manual. We reserve the right to revise this document and make changes in the specification of the product described within at any time without obligation to notify any person of such revision or change. Trademarks WELCH ALLYN SCHILLER and MT-100 are registered trademarks of WELCH ALLYN SCHILLER. All trademarks are the property of their owners. Copyright Notice © Copyright 1998 and 1999 by WELCH ALLYN SCHILLER. All rights reserved. You may not reproduce, transmit, transcribe, store in a retrieval system or translate into any language, in any form or by any means, electronic, mechanical, magnetic, optical, chemical, manual or otherwise, any part of this publication without express written permission of WELCH ALLYN SCHILLER. Terms of Warranty WELCH ALLYN SCHILLER warrants the MT-100 Holter Recorder when new, to be free of defects in material and workmanship and to perform in accordance with manufacturer`s specifications for the period of one (1) year from the date of purchase from Welch Allyn or it`s authorized distributors or agents. Accessory items such as electrodes, batteries and cables are limited to a warranty of 90 days from the date of purchase from Welch Allyn or its authorized distributors or agents. Welch Allyn will repair or replace any components found to be defective or at variance from manufacturer`s specifications within this time at no cost to the customer. It shall be the purchasers responsibility to return the instrument to Welch Allyn or an authorized distributor, agent or service representative. This warranty does not include breakage or failure due to tampering, misuse, neglect, accidents, modifications or shipping. This warranty is also void if the instrument is not used in accordance with manufacturer`s recommendations or if repaired by other than a Welch Allyn or authorized agent. Purchase date determines warranty requirements. No other express warranty is given.

MT-100

Holter Recorder / Enregistreur Holter

Operating Instruction Booklet - Manuel d'Utilisateur

PHYSICIAN`S RESPONSIBILITY THE MT-100 HOLTER RECORDER AND THE MT-200 DATA MANAGEMENT PROGRAM ARE PROVIDED FOR THE EXCLUSIVE USE OF QUALIFIED PHYSICIANS OR PERSONAL UNDER THEIR DIRECT SUPERVISION. THE NUMERICAL AND GRAPHICAL RESULTS FROM A RECORDING MUST BE EXAMINED WITH RESPECT TO THE PATIENT`S OVERALL CLINICAL CONDITION. THE RECORDING

PREPARATION QUALITY AND THE GENERAL RECORDED DATA QUALITY, WHICH

COULD EFFECT THE REPORT DATA ACCURACY, MUST ALSO BE TAKEN INTO ACCOUNT.

IT IS THE PHYSICIAN`S RESPONSIBILITY TO MAKE THE DIAGNOSIS OR TO OBTAIN EXPERT OPINION ON THE RESULTS, AND TO INSTITUTE CORRECT TREATMENT IF INDICATED. FEDERAL LAW IN THE USA RESTRICTS THE SALE OF THE MT-100 TO, OR BY THE ORDER OF A PHYSICIAN. PATIENT POPULATION THE ECG DEVICE MT-100 IS A RECORDING DEVICE USED FOR HOLTER RECORDINGS FOR A MEDICAL EXAMINATION IN HUMAN BEINGS OF ANY AGE, ANY SEX, AND ANY RACE.

SAFETY WARNINGS WHEN A NEW HOLTER RECORDING IS INCORRECTLY STARTED, THERE IS A

POSSIBILITY THAT THE RECORDED ECG DATA FROM THE PREVIOUS PATIENT WILL

REMAIN IN THE MT-100 MEMORY. THEREFORE, IT IS IMPORTANT TO CORRECTLY START THE MT-100 WHICH WILL BE INDICATED BY THE LED BLINKING EVERY 2.5

SECONDS.

THE MT-100 MUST BE DISCONNECTED FROM THE PATIENT DURING DEFIBRILLATION. DO NOT USE THE MT-100 IN THE PRESENCE OF INFLAMMABLE GASES SUCH AS

ANAESTHETIC AGENTS.

THE MT-100 PRODUCT IS NOT DESIGNED FOR STERILE USE. DO NOT IMMERSE THE MT-100 IN LIQUID, NOR USE SOLVENT CLEANERS, HIGH

TEMPERATURE STERILISING PROCESSES (SUCH AS AUTOCLAVE), E-BEAM OR GAMMA RADIATION STERILISATION.

WA MT-100 Instruction Booklet. Article No. 2. 510 108. Copyright © 1997 - 1999 by SCHILLER AG

MT-100

Holter Recorder / Enregistreur Holter

Operating Instruction Booklet - Manuel d'Utilisateur

RESPONSIBILITE DU MEDECIN LE LOGICIEL DE TRAITEMENT DE DONNÉES MT-200 EST DESTINÉ UNIQUEMENT À L'USAGE DE MÉDECINS QUALIFIÉS OU DE PERSONNEL SOUS LEUR SUPERVISION DIRECTE. LES RÉSULTATS NUMÉRIQUES ET GRAPHIQUES D'UN ENREGISTREMENT SONT À METTRE EN RELATION AVEC L'ÉTAT DE SANTÉ GÉNÉRAL DU PATIENT. EGALEMENT À PRENDRE EN CONSIDÉRATION SONT LA QUALITÉ DE LA PRÉPARATION DE L'ENREGISTREMENT AINSI QUE LA QUALITÉ GÉNÉRALE DES DONNÉES ENREGISTRÉES. CELLES-CI SONT SUSCEPTIBLES D'INFLUENCER LES RÉSULTATS ET DONNÉES FOURNIES. IL INCOMBE AU MÉDECIN D'ÉTABLIR UN DIAGNOSTIC OU D'OBTENIR UN AVIS D'EXPERT SUR LES RÉSULTATS, PUIS DE METTRE EN OEUVRE LE TRAITEMENT MÉDICAL APPROPRIE.

POPULATION DES PATIENTS L'APPAREIL ECG MT-100 EST UN ENREGISTREUR UTILISÉ POUR DES ENREGISTREMENTS HOLTER ORDONNÉS POUR DES RAISONS MÉDICAUX DANS LES HOMMES, INDÉPENDANT DE L'ÂGE, SEXE OU DE L'ETHNIE.

CONSIGNES DE SÉCURITÉ SI UN NOUVEL ENREGISTREMENT HOLTER A ÉTÉ LANCÉ DE FAÇON INCORRECTE, IL EST POSSIBLE QUE LES DONNÉES ECG DU PATIENT PRÉCÉDEMENT ENREGISTRÉ SE TROUVENT ENCORE DANS LA MÉMOIRE DU MT-100. IL EST DONC NÉCESSAIRE QUE LE MT-100 SOIT LANCÉ CORRECTEMENT, CE QUI EST INDIQUÉ PAR LE LED CLIGNOTANT TOUTES LES 2,5 SECONDES. LE MT-100 DOIT ÊTRE DÉCONNECTÉ DU PATIENT PENDANT UNE DÉFIBRILLATION. LE MT-100 NE DOIT PAS ÊTRE UTILISÉ EN PRÉSENCE DES GAZS INFLAMMABLES COMME LES GAZS ANESTHÉSIQUES. IL N'EST PAS PRÉVU D'UTILISER LE MT-100 EN MODE STÉRILE. N'IMMERGER LE MT-100 DANS AUCUN LIQUIDE. N'UTILISER PAS DE DÉTERGENTS LIQUIDES, NE PAS PROCEDER À UNE STÉRILISATION À HAUTE TEMPÉRATURE (AUTOCLAVE), NE PAS UTILISER DE RAYONS ÉLECTRONIQUES DU GAMMA.

WA MT-100 Instruction Booklet. Article No. 2. 510 108. Copyright © 1997 - 1999 by SCHILLER AG

MT-100

Holter Recorder / Enregistreur Holter

Operating Instruction Booklet - Manuel d'Utilisateur

Taking a Holter Recording We strongly recommend to check the ECG signal before commencing every Holter recording using the MT-200 Software. However, the MT-100 Holter recorder can be started without first checking the ECG signal if required. To check the signal from the patient and commence a Holter recording proceed as follows: INSERT FRESH BATTERIES IN THE MT-100. Gently apply downward pressure on the battery cover top and open cover - insert 2 AA 1.5V batteries - ensure correct orientation of the batteries. Close battery cover and 'click' to secure. Prepare patient (Electrode placement shown). Form a stress loop in every lead for electrode security and patient comfort. Give enough slack between stress loop and electrode to allow patient to move without affecting electrode positioning. Secure leads and electrodes with tape or plaster. Instruct patient to place hands above head, ensure that the electrodes remain positioned and that no undue stress is placed on the leads and electrode positions. Electrode Placement Holter ECGs use a bipolar lead system (one positive and one negative lead) for each channel. Channel 1 approximates to modified lead V5; Channel 2 approximates to modified lead V2 . Channel 1

Place the WHITE negative electrode under the clavicle on the right sternal margin. Place the RED positive electrode in the fifth left intercostal space on the anterior axillary line (position approximately equates to V5).

Channel 2

Place the BROWN negative electrode under the clavicle to the left sternal margin. Place the BLACK positive electrode in the fourth left intercostal space near the sternum (position approximately equates to V2 ).

Ground

The GREEN ground electrode should be centered over a rib on the right side of the body. Exact placement is not critical and does not affect the recording ° The suggested electrode placement is given a guide. Other electrode configurations are possible. ° Ensure that the QRS complex is bigger than the T wave. ° To avoid artifacts in women patients the red and black electrodes can be placed lower if necessary

Windows® is a trademark of Microsoft Corporation

MT-100

Holter Recorder / Enregistreur Holter

Operating Instruction Booklet - Manuel d'Utilisateur

Taking a Holter Recording ° ° °

Remove the Protective cover on the Opto (PC) connector on the MT-100 Holter unit Remove the protective cover on the opto connector on the back of the PC Connect the MT-100 Holter recorder to the opto connector on the back of the PC with the opto cable assembly

The special opto cable must be handled with care. To ensure reliable service from the opto cable observe the following points: • Take care not to crush the cable with a heavy object. • Take care not to run over the cable with, for example a chair. • Do not tread on the cable. • When not in use, coil the cable in a loop - DO NOT BEND.

PC Opto Connector LED Indicator

Event Button °

Open the MT-200 program on the desktop (double click with the mouse) or the Start menu>Schiller>MT-200. The welcome page is displayed:

°

With the mouse click on the `New Recording` icon on the extreme left of the function icon bar.

The patient data screen is displayed:

WA MT-100 Instruction Booklet. Article No. 2. 510 108. Copyright © 1997 - 1999 by SCHILLER AG

MT-100

Holter Recorder / Enregistreur Holter

Operating Instruction Booklet - Manuel d'Utilisateur

Taking a Holter Recording °

Enter patient data. •

Select the next data entry field with the mouse

OR

•

Select the next data entry field with the TAB key on your computer

If the patient is known to have a pacemaker fitted check the pacemaker box. If this box is not ticked pacemaker spikes will not be detected or displayed.*

*

°

When the details of the patient have been entered press the ENTER key on your computer or click with the mouse on OK. The electrode screen is displayed.

°

Switch the MT-100 on by pressing the event button.

°

Click OK (in the above screen). The patients ECG is displayed.

For pacemaker signals to be detected by the MT-200, the pacemaker detection function must be switched on at the MT-100 before starting data acquisition - this is done by checking the pacemaker box in the patient data screen. Pacemaker signals are detected in the long-term ECG recording by the MT-100 when the slopes and amplitudes of the signal exceeds preset limits and when pacemaker detection is enabled. The MT-200 program cannot determine pacemaker spikes itself and it is not possible to detect pacemaker signals by later analyzing the recording in the program if the pacemaker detection function was not enabled during the original recording. Pacemaker detection is confined to the first channel of the MT-100 and is therefore optimal when the amplitude of the pacemaker signal for the first ECG channel is greater than that for the second channel. In some instances this is not the case, and it is recommended that the real-time ECG traces are viewed on the screen before starting the long-term recording. Pacemaker detection is automatically enabled on the real time display. The pacemaker signals however, are not always detected. If this is the case and the amplitude of the pulse is greater in the second channel, simply exchange the electrodes of channels 1 and 2.

MT-100

Holter Recorder / Enregistreur Holter

Operating Instruction Booklet - Manuel d'Utilisateur

Taking a Holter Recording

°

Check the signal - reapply electrodes if necessary.

°

Click START RECORDING to commence the recording. Recording has now commenced and the MT-100 will continue to record the patients ECG for 24 hours or until terminated. Recording is indicated on the MT-100 by the LED indicator flashing every 2.5 seconds.

°

Remove the connector from the Holter Recorder MT-100 and replace the protective cover over the connector.

°

Remove the connector from the PC and replace the protective cover on the connector.

°

Instruct the patient on use. The following should be mentioned: -

-

Logging the time of activities and symptoms in the patient diary. Instruct the patient to press the EVENT button at any time during the recording to register an event. Event acknowledgment is given by the LED flickering continuously for approximately 7.5 seconds. The MT-100 is not waterproof - the patient should be advised not to take a bath or shower.

MT-100 Indications During Use The following table gives the MT-100 LED indications during use. MT-100 Functions

LED Indication

Unit active

LED lit - momentarily flashes off every 2.5 seconds

Unit Recording

LED off - momentarily flashes on every 2.5 seconds

Event Recorded (during recording)

Blinks continuously for 7.5 seconds after an event is recorded (event button pressed during recording).

Monitor mode - ECG displayed on PC

Flashes off and on (ON 1s, OFF ¼s)

Downloading recording to PC

Flashes on and off (ON ¼s, OFF 1s)

WA MT-100 Instruction Booklet. Article No. 2. 510 108. Copyright © 1997 - 1999 by SCHILLER AG

MT-100

Holter Recorder / Enregistreur Holter

Operating Instruction Booklet - Manuel d'Utilisateur

Taking a Holter Recording without the MT200 PC Program

Starting the Holter recording without the PC program is not recommended as the signal levels cannot be checked. Only do this when the PC program is inaccessible. To start the Holter independently procede as follows: °

Connect the Patient as described in Section 1

°

Insert new batteries in the MT-100

°

Switch the MT-100 on - press the event button. The LED lights and momentarily flashes off every 2.5 seconds.

°

To start recording press the event button for approximately 4 seconds. The LED switches off and recording is indicated by the LED flashing momentarily every 2.5 seconds.

Stopping the Recording When the memory is full (approximately 24-25 hours), recording is stopped automatically - the LED stops blinking. The data remains in the memory until downloaded to the PC. To stop the recording prematurely, °

First remove the electrodes from the patient

°

Hold the event button pressed for approximately 4 seconds until the LED lights continuously then release the button.

°

The LED extinguishes and the MT-100 is switched off.

Downloading to the PC Download the recording data as detailed in Section 1 of the MT-100/ MT-200 User Guide.

MT-100

Holter Recorder / Enregistreur Holter

Operating Instruction Booklet - Manuel d'Utilisateur

MT-100 Technical Data Technical data subject to change without notice. Dimensions

110 x 70 x 19 mm; 4.3 x 2.7 x 0.7 ins

Weight

140 grams; 0.3 lbs (with batteries)

Battery

AA alkaline 1.5V (2 off)

Battery Capacity

Working time 24 hours plus data transfer

Power Consumption

120mW (recording)/360mW (monitoring or downloading)

Data Acquisition

Simultaneous sampling of two channels

Environmental Conditions:

Temperature, Operating:

10O to 40OC

Temperature, Storage:

-10O to 50O C

Relative humidity:

25 to 95% (non condensing)

Atmospheric pressure:

700 to 1060 hPa

Sampling frequency:

500 Hz

Digital resolution:

12.5 µV

Dynamic range:

±5.5 mVAC

Max. electrode potential:

±300 mVDC

Time constant:

3.2 s

Frequency response:

0.05 to 150 Hz (-3 dB)

Input impedance:

>2.5MOhms at 10Hz

Common Mode rejection

> 100dB

ECG Amplifier:

Patient Input:

Fully floating and isolated, defibrillation protected.

Safety Standard:

BF according to IEC and complying with the following RL 93/42/EEC EN 60601-1:1990 IEC 601-1 IEC 601-2-25:1993 pr EN 1441:1994

EMC:

CISPR 11: 1985, EN 55011: 1992 IEC 801-2: 1991 IEC 801-3: 1984 IEC 801-4: 1988 IEC 801-5:

Safety Class:

I according to IEC 601-1 (with internal power supply)

Data subject to change without notice.

WA MT-100 Instruction Booklet. Article No. 2. 510 108. Copyright © 1997 - 1999 by SCHILLER AG

MT-100

Holter Recorder / Enregistreur Holter

Operating Instruction Booklet - Manuel d'Utilisateur