Custo Med Custo Guard 1/3 User manual

Operating Manual
Cardiac Rehabilitation
Part 2: Hardware, description of device for custo guard (custo cardio concept)
123 4
Safety Hardware Software Hygiene
Operating characteristics:
1, 3-channel ECG,
Cardiac rehabilitation
MHW 0010 – DK 1696
Version 001 – 21/09/2017

[2] Cardiac Rehabilitation hardware, custo guard (custo cardio concept) | page 2
© 2017 custo med GmbH
This Operating Manual may not be copied in its entirety or in part, duplicated in any
form or by any means or translated into another 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 be downloaded from our web-
site: www.customed.de.
CAUTION:
This Operating Manual is part of a modular system consisting of four parts. All
four parts must be downloaded from the Internet or from a CD to ensure the
Operating Manual is complete.
MHW 0010 – DK 1696 | Version 001 – 21/09/2017 | custo med GmbH [2] Cardiac Rehabilitation hardware, custo guard (custo cardio concept) | page 2

MHW 0010 – DK 1696 | Version 001 – 21/09/2017 | custo med GmbH [2] Cardiac Rehabilitation hardware, custo guard (custo cardio concept) | 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 the custo guard ECG transmitter .............................................9
2.5 Preparing the patient ........................................................................10
2.5.1 Fitting the custo guard ECG transmitter with
an electrode belt ...................................................................10
2.5.2 Sitting position on the ergometer ............................................11
2.5.3 Blood pressure cuff ................................................................11
2.5.4 Adjusting the length of the custo belt 3
(for 3-channel ECG) ...............................................................12
2.5.5 Attaching custo guard 1 without an electrode belt
to the patient........................................................................14
2.5.6 Attaching custo guard with custo ECG cable guard 3 .................15
2.6 Technical data and system requirements..............................................16
2.7 Manufacturer's declaration regarding EMC. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .18
2.8 EC Declaration of Conformity .............................................................21
2.9 List of product components and accessories .........................................23
Operating Manual
Cardiac Rehabilitation
Part 2: Hardware, description of device for custo guard (custo cardio concept)
123 4
Safety Hardware Software Hygiene

MHW 0010 – DK 1696 | Version 001 – 21/09/2017 | custo med GmbH
2
[2] Cardiac Rehabilitation hardware, custo guard (custo cardio concept) | page 4
Cardiac Rehabilitation
Hardware, description of device for custo guard (custo cardio concept)
IP65
Manufacturer:
custo med GmbH, Maria-Merian-Str. 6, 85521 Ottobrunn, Germany
CE mark
Observe the Operating Manual
Separate collection of electrical and electronic equipment,
do not dispose with domestic waste
Medical electrical equipment classification
according to DIN EN 60601-1 (Type BF)
Safety class of electrical equipment
(protection against the ingress of foreign matter and spray water)
2.1 Symbols on the device

MHW 0010 – DK 1696 | Version 001 – 21/09/2017 | custo med GmbH
2
[2] Cardiac Rehabilitation hardware, custo guard (custo cardio concept) | page 5
Cardiac Rehabilitation
Hardware, description of device for custo guard (custo cardio concept)
2.2 Intended use
The custo guard ECG transmitter (always includes the custo belt electrode belt) is
used for receiving a 1 or 3-channel ECG signal in accordance with Holter standards.
The ECG is then processed by custo diagnostic. custo guard is an ECG transmitter
with an internal power supply that transmits the data by radio waves.
custo guard is used in cardiac rehabilitation for wireless patient monitoring. The ra-
dio transmission allows continuous monitoring of patients independent of exercise
station. Via the real-time transmission of the ECG signal in custo diagnostic, the
therapist is aided in the visual monitoring of patients.
custo guard can safely be used on patients with pacemakers. Caution! The ECG
recording may be affected by pacemaker pulses.
The system is intended for use by trained specialist staff or physicians in clinics and
rehab centres.
The system is not suitable for electrocardiographic monitoring of patients in accord-
ance with DIN EN 60601-2-27, e.g. use in intensive care.