Page 287 - Safety Risk Management for Medical Devices

266 Appendix C: Example Device—Vivio

Vivio is comprised of the base unit, two disposable pads, and the outer casing.
The user is expected to apply the pads to the victim’s bare chest according to the
drawings on the pads, and follow the verbal instructions given by the base unit.

C.2 VIVIO PRODUCT REQUIREMENTS

The following are the System requirement specifications for Vivio:
• Automatically detect ventricular fibrillation with a sensitivity of $ 95% and speci-
ficity of $ 90%
• Deliver at least 150 joules of energy per shock
• Able to deliver a minimum of 200 shocks on a fresh battery
• Standby longevity $ 4 years on a fresh battery
• Max time between shocks: 20 seconds
• Able to detect and cope with artifacts, e.g., implanted pacemakers
• Visible indication of readiness for use
• Protective case for installation in public spaces
• Weight: # 2 kg (with battery, case, and pads)
• Resistance to dust and water ingress:
• While inside the case: IP54 or better
• While outside the case: IP52 or better