MHW 0012 – DK 1713 | Version 004 – 20/04/2020 | custo med GmbH
2
Resting and Stress ECG
Hardware, description of device for custo cardio 400 BT and custo cardio 400 accu
[2] Resting and Stress ECG Hardware, custo cardio 400 devices |
page 5
2.2
Intended
use
custo cardio 400 BT / custo cardio 400 accu is a 12-channel electrocardiograph
with integrated electrode application system which is used professionally as a rest-
ing or stress ECG. The electrode application system is used to attach the electrodes
to the patient‘s body using underpressure. R, L and F according to Einthoven and C1
to C6 according to Wilson are used as derivations.
Intracardiac application is not intended.
The unit has no protection against possible influences of
high-frequency surgery devices.
The custo cardio 400 devices can be used safely for patients with pacemakers. ECG
recording is not affected by pacemaker pulses.
Users are trained specialists in medical practices, laboratories, rehabilitation facilities
or hospitals. These include in particular doctors and medical-technical assistants.
Use at home, especially by laypersons, is not part of the intended use.
