2
Holter ABPM
Hardware, description of device for custo screen 400
MHW 0004 – DK 1663 | Version 001 – 12/01/2018 | custo med GmbH
[2] Holter ABPM Hardware, custo screen 400 |
page 5
2.2
Intended
use
custo screen 400 is a Holter ABPM recorder with an internal power supply for
synchronous ABPM and Holter recording. The recording can last for up to 24 hours
and is used to evaluate blood pressure behaviour, in combination with the ECG
recorded for this purpose.
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 screen
400 recorder via radio. The 3-channel ECG is received in the recorder via a radio
interface.
custo screen 400 can also be used to carry out separate ABPM recordings (max.
72 hours) OR Holter recordings (max. 24 hours). The type of recording is defined
when the recorder is started in the medical operating system custo diagnostic.
custo screen 400 is perfectly safe for patients with a pacemaker. Pacemaker
recognition is not possible. Caution: The ECG recording may be affected by pace-
maker 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
understanding and following the instructions given are not allowed to use the
device. This applies in particular to senile patients or patients suffering from
dementia.
The system is not suitable for unsupervised use with unconscious patients
(applies to recordings with ABPM measurement).
The system (custo guard 3) is not suitable for intracardiac use.
The system is not suitable for electrocardiographic monitoring of patients
in accordance with DIN EN 60601-2-27, e.g. use in intensive care.
