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Custo Med custo belt, Руководство по эксплуатации

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MHW 0008 – DK 1695  |  Version 002 – 21/08/2019  |  custo med GmbH

[2] Holter hardware, custo watch | 

page 3

Table of contents

2.1 

Symbols on the devices

 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

4

2.2 Intended 

use

 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

5

2.3 

Part names, components for the recording

 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

6

2.4   Charging custo watch and custo guard

 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

7

2.5   Device operation custo watch and custo guard 

 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

8

 

2.5.1 

Display and control elements on the devices

 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

8

 

2.5.2   Changing the custo watch strap set

 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

8

 

2.5.3   custo watch information elements 

   during 

recording

 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

9

 

2.5.4   Operating the custo watch display

 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

10

2.6   Attaching the holter recorder to the patient

 

2.6.1 

Fitting the custo watch

 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

13

 

2.6.2   Fitting the custo guard ECG transmitter with electrode belt

 . . . . . . . .

13

 

2.6.3   Length adjustment of the custo belt 3

 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

14

 

2.6.4   Attaching custo guard with ECG cable custo guard 3

 . . . . . . . . . . . . . . . . .

16

2.7 

Patient instructions, handling of the device

 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

17

2.8   Technical data and system requirements

 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

18

2.9 

Manufacturer’s declaration regarding EMC 

 (electromagnetic 

compatibility) 

 

according to DIN EN 60601-1-2:2016-05

 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

22

2.10  EC Declaration of Conformity

 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

25

2.11  List of product components and accessories

 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

27

Operating Manual

Holter

Part 2: Hardware, description of device for custo watch

1

2

3

4

Safety

Hardware

Software

Hygiene

Содержание custo belt

Страница 1: ...Manual Holter Part 2 Hardware description of device for custo watch 1 2 3 4 Safety Hardware Software Hygiene Operating characteristics For 3 channel holter up to 72 hours MHW 0008 DK 1695 Version 002...

Страница 2: ...nother language without the prior written consent of custo med GmbH The manufacturer reserves the right to change the information in this Operating Manual without prior notice The current version can...

Страница 3: ...play 10 2 6 Attaching the holter recorder to the patient 2 6 1 Fitting the custo watch 13 2 6 2 Fitting the custo guard ECG transmitter with electrode belt 13 2 6 3 Length adjustment of the custo belt...

Страница 4: ...r custo med GmbH Maria Merian Str 6 85521 Ottobrunn Germany CE mark Medical electrical equipment classification according to DIN EN 60601 1 Type BF Observe the Operating Manual Protection class of ele...

Страница 5: ...perfectly safe for patients with a pacemaker Pacemaker recognition is not possible with the device Caution The ECG recording may be affected by pacemaker pulses The system is intended for use by trai...

Страница 6: ...usto guard 3 3 channel ECG transmitter custo belt 3 red 3 channel electrode belt custo belt 1 3 extender extension piece for the electrode belt Washing net for custo belt custo docking station charger...

Страница 7: ...mark appears for the corresponding device If the rechargeable bat tery capacity is less than 24 hours the current charge status is displayed If there is no custo guard 3 ECG transmitter on the custo d...

Страница 8: ...dicates the opera tional readiness of the system when both devices are in the custo docking station and connected to the PC or power supply unit 2 5 2 Changing the custo watch strap set To change the...

Страница 9: ...ppears when the connection to the ECG transmitter is successful ECG symbol appears when QRS complexes are detected Recording symbol appears when the ECG recording has been started Duration of current...

Страница 10: ...ay by briefly pressing the grey button To ensure a full 24 hour or 72 hour recording both devices must be sufficiently charged If the custo watch is outside the custo docking station the display is sw...

Страница 11: ...played see The grey button is then held pressed approx 10 seconds until the Finish recording query appears in the display The recording is ended by briefly pressing the grey button again The message R...

Страница 12: ...ge 12 Memory full The memory card in the custo watch is full The custo watch must be downloaded into custo diagnostic before a new recording can be performed The data are stored in the custo diagnosti...

Страница 13: ...oiled Soiling will affect the quality of the ECG1 CAUTION The electrode contact surfaces must always be in contact with the skin Ensure that there are no textiles between the electrode and the skin Ma...

Страница 14: ...ed directly next to the point where the material becomes wider on the custo belt The elastic excess length is completely pulled through the slider so that the slider is directly next to the black plas...

Страница 15: ...k and the wide material point Extension with the custo belt extender If the maximum length is not sufficient use a custo belt extender extension piece The custo belt extender is adjusted to the minimu...

Страница 16: ...sensive to the cable ends Attach the neck strap to the hooks of the ECG cable custo guard 3 Put the ECG transmitter around the patients neck and adjust the neck strap to the desired length Clean the...

Страница 17: ...er A custo belt electrode belt stretches after prolonged wear due to moisture sweat The custo belt should be re tensioned after some time so that it rests firmly against the upper body again and to en...

Страница 18: ...Pa Classification Device with internal power supply Class IIa Type BF Underlying standards DIN EN 60601 1 DIN EN 60601 1 2 DIN IEC 60601 2 47 Technical data custo docking station Connection to the PC...

Страница 19: ...10 95 rH Air pressure 700 1060 hPa Classification Device with internal power supply Class IIa Type BF Underlying standards DIN EN 60601 1 DIN EN 60601 1 2 DIN EN 60601 2 47 Technical data custo belt 3...

Страница 20: ...r 2012 R older versions are not supported PC The PC hardware should meet the minimum requirements of the operating system used Provide additional RAM 1 GB for custo diagnostic Please ensure that there...

Страница 21: ...sition systems Fanless Dual DVI or DP graphics card for CPET Windows 8 1 x64 PRO version for joining a domain Ports One USB 2 0 port per USB device preferably not USB 3 0 One COM port each for ergomet...

Страница 22: ...ccording to IEC61000 3 2 Voltage fluctuations flickers according to IEC61000 3 3 Compliance Group 1 Class B Not applicable Not applicable Electromagnetic environment guidelines custo watch uses the fr...

Страница 23: ...80 MHz are 6 765 to 6 795 MHz 13 553 MHz to 13 567 MHz 26 957 MHz to 27 283 MHz and 40 66 MHz to 40 70 MHz The amateur radio bands between 0 15 MHz and 80 MHz are 1 8 MHz to 2 0 MHz 3 5 MHz to 4 0 MH...

Страница 24: ...ided as this could result in fault operation If the devices must nonetheless be used as described above this device and the other devices should be monitored to ensure proper functionality a For some...

Страница 25: ...MHW 0008 DK 1695 Version 002 21 08 2019 custo med GmbH 2 Holter Hardware description of device for custo watch 2 Holter hardware custo watch page 25 2 10 EC Declaration of Conformity...

Страница 26: ...MHW 0008 DK 1695 Version 002 21 08 2019 custo med GmbH 2 Holter Hardware description of device for custo watch 2 Holter hardware custo watch page 26...

Страница 27: ...Z 1 Strap set for custo watch large circumference 180 260 mm 10302 1 custo guard 3 10301 R 1 custo belt 3 red for custo guard 3 10118 1 custo belt 1 3 extender for custo guard 1 3 10121 1 1 ECG cable...

Страница 28: ...Manufacturer s contact details custo med GmbH Maria Merian Stra e 6 85521 Ottobrunn Germany Phone 49 0 89 710 98 00 Fax 49 0 89 710 98 10 E mail info customed de Internet www customed de...

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