Device Dossier
Vkit - Telemetry system, electrocardiograph
Device Dossier for Vkit - Telemetry system, electrocardiograph (Telemetry system, electrocardiograph, Class IIa, sponsor Vpatch Cardio). ARTG record,…
- GMDN category: Telemetry system, electrocardiograph
Intended purpose
The Vpatch system is intended for patients requiring ambulatory monitoring and is controlled via a central point by a clinician. The system is suitable for patients experiencing symptomatic or asymptomatic cardiac arrhythmias. The device is a small, battery operated, portable Remote Event Monitor (REM) system connected to an accessory (electrocardiograph (ECG) electrode) which in turn is in contact with the patient's body. The REM, with arrhythmia detection, is designed to monitor and record ECG rhythms by sending ECG data using a long range repeater accessory to a remote device for analysis. The device is intended to obtain readings of vital physiological data in routine checkups. Any events or variations in vital signs are not intended to be used to summon emergency care. The device is re-usable and intended to be used on the patient for short term periods only.