Device Dossier
Cable/lead, electrocardiograph
Device Dossier for Cable/lead, electrocardiograph (Cable/lead, electrocardiograph, Class IIa, sponsor GE Healthcare). ARTG record, intended purpose, GMDN…
- GMDN category: Cable/lead, electrocardiograph
- Sponsor: GE Healthcare
Intended purpose
This device is intended to assist in the application of ECG electrodes for the recording of resting and stress test ECGs by using an adjustable vacuum to hold the electrodes in place at the respective electrode sites on the skin. The intended use of the hose is to stretch the connection for the partial vacuum between the suction pump connector and the KISS suction tube. The intended use of the electrodes is the placement on the patient’s body to collect electrical signal from the heart. The adherence is done by a partial vacuum.