Certification of Transport Medical Equipment

1. Certification of Transport Medical Equipment Ensuring Patient Safety and Wellbeing While in the Air Chris Raynes Senior Design and Certification Engineer

2. Introduction Taken individually each component of a medical fit-out is not complex but when combined into a medical system the certification complexity increases There is often confusion from the customer as why equipment suitable for use in an intensive care medical environment requires such attention when used on an aircraft There is a balancing act between patient well-being and airworthiness during medi-vac operations

3. MEDI-VAC OPERATION • Evacuation or patient transfer • Occupant is often critically ill • Medical staff are in constant attendance • Flight is at all times and all weather conditions • Role equipment is removable • Equipment is certified to medical standards

4. Medical Transport Equipment Certification Medical Transport Systems are designed to provide self contained life support and monitoring of a patient while in transit between medical facilities.

5. Medical Equipment A typical medical fit out will contain a wide range of medical equipment including but not limited to: • Monitor • Ventilator • Syringe pumps • Air / oxygen blender • Suction pump • Infant incubator • Heated mattress • Oxygen supply – portable bottle • Air supply – portable bottle • Patient Stretcher

6. Transport Incubator The transport incubator makes an ideal case study to cover the certification issues common to medical equipment fits

7. Ventilator Monitor Batteries Incubator Oxygen Cylinder Air Cylinder Trolley Base for Aircraft Interface Syringe Driver Humidifier Vacuum

8. Certification Points • Patient restraint • Restraint of items of mass • Component fire resistance • Electrical system safety and function • Electromagnetic compatibility

9. CERTIFICATION GUIDANCE • FAA AC135-14A EMS HELICOPTERS • FAA AC135-15 EMS AIRCRAFT • CAANZ AC43-14 AVIONIC SYSTEMS • CAA ACU STAFF

10. Patient Restraint • Require full restraint harness with additional straps to support the lower body Applicable Design Standards are: • TSO-C114 - Torso Restraint Systems • TSO-C22G - Safety Belts

11. Items of Mass Restraint • Restraint of mass is not insignificant • A typical incubator assembly has a certified weight in the order of 140 kgs. • Combined with an operational requirement for a simple stretcher latching system. • Most aircraft make use of a locating frame for the stretcher which may be supplemented through the use of tie-down straps.

14. Fire Resistance • The certification basis for the medical transport aircraft typically requires all materials to be “Flame-Resistant” or “Flash-Resistant”. • This requirement is common to the medical certification requirements • All other non-metallic components are either aircraft specification or tested to demonstrate compliance

15. System Safety • Power is distributed from the medical batteries to the medical equipment through inverters and converters as required. • All electrical wiring, circuit breakers, switches, etc must comply with the appropriate aircraft standards. • A functional check of the electrical system is carried out to ensure that all the components operate correctly and remain within manufacturers recommended temperatures.

16. Electromagnetic Compatibility • Electromagnetic Compatibility can be the most challenging certification requirement to meet, due in part to final checks that are required to be accomplished with the medical system installed into the aircraft. • Several common medical components are known to produce electromagnetic interference: • Incubator heating controllers • Switch-mode power supplies commonly used in AC to DC voltage converters • DC to AC power inverters

17. EMC Compliance The paths available to demonstrate compliance. • Obtain DO160 Section 21 Category M Certification. • For IFR approval flight testing may be required. • For VFR approval ground testing for NAV/COM radio interference is required.

18. EMC Compliance • A large proportion of the medical components comply with ISO 60601-1-2 EMC standard which is less stringent than the DO160 requirements, with compliance making the equipment acceptable for use during the cruise flight phases on an IFR rated aircraft without the need for flight testing. • All equipment installations undergo ground EMC checks following the guidance from CAA AC43-14 and FAA AC43.13-2B to ensure that there is no radiated or conducted interference with the aircraft navigation and communication systems.

19. Summary • Equipment fits designed and approved for use in intensive care units and ambulances require attention to be approved for use on aircraft. • In some cases medical equipment do not meet the aircraft standards and require upgrades to show compliance with the aircraft standards.

20. QUESTIONS

21. Batteries – Deep Cycle Sealed Lead Acid (SLA) Voltage converters – 12/24 VDC  18 VDC - 12 VDC  24 VDC - 24 VDC  12 VDC Power converters – 12/24 VDC  240 VAC Battery charging from 12VDC, 24VDC, 115VAC, or 240VAC aircraft power supply. Electrical Equipment The majority of the electrical medical equipment is powered by individual internal rechargeable batteries. In support of longer duration patient transport missions supplemental power supplies to the medical equipment internal batteries is required. The additional power may be supplied from a combination of aircraft power and the following components: