Device Dossier
Patient monitor, cardiotocograph
Device Dossier for Patient monitor, cardiotocograph (Patient monitor, cardiotocograph, Class IIb, sponsor Wiselink Group). ARTG record, intended purpose,…
- GMDN category: Patient monitor, cardiotocograph
Intended purpose
This product is intended for use in hospital to monitor the maternal ECG, heart rate, NIBP, SpO2, pulse, pulse rate, respiration, temperature, TOCO, and to monitor fetal heart rate and fetal movement. This product is expected to be used in the labor and delivery room, in the prenatal examination room, and during postpartum recovery. All models of monitors shall be operated by trained health care professionals.