Download Certification of Transport Medical Equipment

Flight Structures Ltd
Hamilton
Certification of Transport
Medical Equipment
Ensuring Patient Safety
and Wellbeing While in the Air
Flight Structures Ltd
Aircraft & Helicopter Certification Consultants
CAA Approved:
Part 146 Design Organisation
Phone: +(64) 7 843-1128
Fax : +(64) 7 843-1129
Website: www.flightstructures.co.nz
Chris Raynes
Senior Design and Certification Engineer
Flight Structures Ltd
Hamilton
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
Flight Structures Ltd
Hamilton
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
Flight Structures Ltd
Hamilton
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.
Flight Structures Ltd
Hamilton
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
Flight Structures Ltd
Hamilton
Transport Incubator
The transport incubator makes an ideal
case study to cover the certification issues
common to medical equipment fits
Flight Structures Ltd
Hamilton
Ventilator
Monitor
Batteries
Incubator
Oxygen
Cylinder
Air
Cylinder
Trolley
Base for
Aircraft
Interface
Vacuum
Humidifier
Syringe
Driver
Flight Structures Ltd
Hamilton
Certification Points
•
•
•
•
•
Patient restraint
Restraint of items of mass
Component fire resistance
Electrical system safety and function
Electromagnetic compatibility
Flight Structures Ltd
Hamilton
CERTIFICATION GUIDANCE
• FAA AC135-14A EMS HELICOPTERS
• FAA AC135-15 EMS AIRCRAFT
• CAANZ AC43-14 AVIONIC SYSTEMS
• CAA ACU STAFF
Flight Structures Ltd
Hamilton
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
Flight Structures Ltd
Hamilton
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.
Flight Structures Ltd
Hamilton
Flight Structures Ltd
Hamilton
Flight Structures Ltd
Hamilton
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
Flight Structures Ltd
Hamilton
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.
Flight Structures Ltd
Hamilton
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
Flight Structures Ltd
Hamilton
EMC Compliance
The paths available to demonstrate
compliance.
1. Obtain DO160 Section 21 Category M
Certification.
2. For IFR approval flight testing may be
required.
3. For VFR approval ground testing for
NAV/COM radio interference is required.
Flight Structures Ltd
Hamilton
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 AC4314 and FAA AC43.13-2B to ensure that there is
no radiated or conducted interference with the
aircraft navigation and communication systems.
Flight Structures Ltd
Hamilton
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.
Flight Structures Ltd
Hamilton
QUESTIONS
Flight Structures Ltd
Hamilton
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:
• 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.
Flight Structures Ltd
Hamilton
Flight Structures Ltd
Hamilton