 Safety Certification
Safety certified to UL60601 standard HIPAA
US FDA 510(k) Clearance for marketing
System protection
|
| |
 Console ON/OFF switch is fused
Bed Base ON/OFF switch is fused
Air/Vacuum Pump relay is overload protected
Air/Vacuum Pump is thermally protected |
Patient Protection
|
| |
Automatic vacuum deflation of cuffs on early/extra
systole
Over pressure limit protection
Treatment is suspended during episodes of high
or low heart rate
Emergency stop switch located on both sides of
the console
Air to cuffs is actively cooled
Auditory alarms: |
| |
- Heart rate out of limits
- Oxygen saturation out of limits*
- Lack of an adequate triggering signal
- Loss of communication between computer and ECP device
|
