Country: Singapura
Bahasa: Inggeris
Sumber: HSA (Health Sciences Authority)
GE HEALTHCARE PTE. LTD.
Class B medical device
GE Healthcare
Cardiovascular
The MAC400 is used under the direct supervision of a licensed healthcare practitioner. Trained operators in small and medium hospitals will use the MAC 400 to record ECG signals from surface electrodes. The MAC400 is intended to acquire, measure, display and record information from adult and pediatric populations. The basic system delivers 3 channels in automatic mode and 1 or 3 channels in manual mode. The arrhythmia detection portion of the MAC400 is provided to the customer for the convenience of automatic documentation. It is not designed to provide alarms for arrhythmia detection. It is not intended for use as a vital signs physiological monitor. The MAC400 is not intended for use during patient transport.
Device System Info:[Device with measuring function], Device with Measuring Function; Models: MAC 400 resting ECG analysis system - 2033547-001, MAC 400 resting ECG analysis system - 2033547-002, IEC starter kit - 2035819-001, AHA starter kit - 2035819-002, PWR SPLY CRD ST BRITISH 10A 250V 2.5M FSD - 401855-102, MAC400 Op. Manual ENG - 2032589-001
2012-03-08