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 5
2.2
Intended
use
The custo watch is a portable Holter recorder with an internal power supply for
recording a 3-channel ECG signal lasting up to 72 hours. The 3-channel ECG signal
is taken via the custo guard 3 ECG transmitter (includes the custo belt 3 electrode
belt) in accordance with the Holter standard. The ECG transmitter has an internal
power supply and transmits the data to the custo watch via radio. The 3-channel
ECG is received and recorded in the Holter device via a radio interface.
The custo watch system is 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 trained specialist staff or physicians in clinics
and medical practices. Patients are only allowed to use the recording device after
receiving instruction by trained specialist staff. Patients who are not capable of un-
derstanding and following the instructions given are not allowed to use the device.
This applies in particular to senile patients or patients suffering from dementia.
custo watch and custo guard are not suitable for intracardiac use.
custo watch and custo guard are not suitable for children with a weight
below 10 kg.
The system is not suitable for electrocardiographic monitoring of patients
in accordance with DIN EN 60601-2-27, e.g. use in intensive care.
