Generic Specification For Special Purpose

Transcript

Page 1 of 68 Business Unit: Cobham Technical Services ERA Technology EMC and RF Group Report Title: Generic Specification for Special Purpose Aeromedical Equipment (SPAME) - Final - Issue 5 Author(s): D A Atkey Client: Medical & General Supplies Team Client Reference: FTS3/MGS006 Report Number: 2009-0522 Project Number: 7V0545601 Report Version: Final Report Report Checked by: Approved by: Roger Smith Martin Ganley Senior Consultant Head of EMC and RF Group September 2009 Ref. DAA/vs/62/05456/Rep-6485 Cobham Technical Services ERA Technology Report 2009-0522 © Crown Copyright 2009 Prepared by Cobham (ERA) on behalf of MoD under cover of contract No. FTS3/MGS006 ERA Technology Limited trading as Cobham Technical Services Cleeve Road Leatherhead Surrey KT22 7SA, England Tel : +44 (0) 1372 367000 Fax: +44 (0) 1372 367099 E-mail: [email protected] Read more about Cobham Technical Services on our Internet page at: www.cobham.com/technicalservices Ref: P:\Projects Database\3. Closed Projects\Med & GS - 7V0545601 Generic Spec for SPAME\Rep-6485 - 2009-0522.doc 2 © Crown Copyright Cobham Technical Services ERA Technology Report 2009-0522 Foreword 1. This specification provides the physical, environmental and medical operational requirements for in-service use of Airworthy Medical Equipment (AME). The objective is to allow the procurement of specific items of medical equipment which will meet the requirements for aeromedical flights, on any aircraft type with potential hazards minimised, and with a reduction in the clearance activities required. 2. The document is designed to provide advice and guidance to specialist medical procurement personnel, manufacturers and suppliers, aircraft platform teams, Release To Service Authorities (RTSA) and assessing bodies. This specification is not to be used as a contractible document. 3. Within this specification the term “shall” indicates a mandatory requirement and “should” is a desirable requirement. Ref: P:\Projects Database\3. Closed Projects\Med & GS - 7V0545601 Generic Spec for SPAME\Rep-6485 - 2009-0522.doc 3 © Crown Copyright Cobham Technical Services ERA Technology Report 2009-0522 This page is intentionally left blank Ref: P:\Projects Database\3. Closed Projects\Med & GS - 7V0545601 Generic Spec for SPAME\Rep-6485 - 2009-0522.doc 4 © Crown Copyright Cobham Technical Services ERA Technology Report 2009-0522 Contents Page No. Foreword 2 Introduction 13 Background 13 Requirement 13 Scope 13 Mechanical, Electrical and Environmental Requirements 14 General Considerations 14 Mechanical Requirements 14 General Considerations 14 Physical Characteristics 15 Electrical Requirements 15 General Considerations 15 Power Sources 16 External power 16 Battery Power 17 Alarms 17 Audible Alarms 17 Visual Alarms 17 Visual Displays 18 Data Interfaces 18 Ref: P:\Projects Database\3. Closed Projects\Med & GS - 7V0545601 Generic Spec for SPAME\Rep-6485 - 2009-0522.doc 5 © Crown Copyright Cobham Technical Services ERA Technology Report 2009-0522 User Requirements 18 In-Service Life 18 Utilisation 18 Reliability/Configuration 19 Commercial-Off-the-Shelf Equipment 19 Configuration Control 19 Personnel Safety 19 Electro-Physical Requirements 20 Environmental Requirements 20 Operating Temperature Range 20 Relative Humidity 20 Altitude/Pressure 21 Depressurisation 21 Rapid Decompression 21 Vibration 21 Acceleration (Crash Conditions) 22 Fluid Contaminant Susceptibility 22 Salt Mist Exposure 23 Water-Proofness 23 Sand and Dust Proofing 23 Shock, Drop and Topple Survivability 23 Electromagnetic Compatibility 24 Radiated Tests Applicable to all AME 24 Ref: P:\Projects Database\3. Closed Projects\Med & GS - 7V0545601 Generic Spec for SPAME\Rep-6485 - 2009-0522.doc 6 © Crown Copyright Cobham Technical Services ERA Technology Report 2009-0522 Radiated Emissions 24 Radiated Susceptibility 24 Conducted Tests Applicable to AME connected to aircraft power supplies 25 Conducted Emissions 26 Conducted Susceptibility (Low Frequency) 26 Conducted Susceptibility (High Frequency) 26 Electrostatic Discharge 26 COMPATIBILITY AND STANDARDIZATION 26 SUPPORT PUBLICATIONS 27 REQUIREMENTS OF AIRCRAFT DESIGN AND TECHNICAL AUTHORITIES28 ELECTRICAL INTERFACE REQUIREMENTS 28 MECHANICAL INTERFACE REQUIREMENTS 28 REQUIREMENTS OF MAINTENANCE AUTHORITIES CONFIGURATION REQUIREMENTS CONTROL AND POST 28 DESIGN STANDARD 29 CONFIGURATION CONTROL 29 IN-SERVICE REQUIREMENTS 29 APPLICABILITY OF STANDARDS 30 UK/International Standards 30 SAFETY CASE ASSESSMENT REPORTING 30 General Considerations 30 Aircraft Safety 30 Ref: P:\Projects Database\3. Closed Projects\Med & GS - 7V0545601 Generic Spec for SPAME\Rep-6485 - 2009-0522.doc 7 © Crown Copyright Cobham Technical Services ERA Technology Report 2009-0522 Patient Safety 31 Evaluation / Safety Case Considerations 31 Additional Considerations 32 Release to Service Documentation 33 Post Clearance Modified Equipment 33 ANNEX LIST 36 ANNEX A: DANGEROUS GOODS AND AIR AMBULANCE FLIGHTS 37 General Comments 37 Flight requirements and storage 38 Exceptions 39 ANNEX B: THE TEAM CUBE 40 INTRODUCTION 40 Critical Care Air Support Team (CCAST) - TEAM CUBE 40 Medical Emergency Response Teams - TEAM CUBE 42 AEROMED TEAM CUBE 44 ANNEX C: EQUIPMENT CLINICAL CAPABILITY 46 INTRODUCTION 46 Electro-Physical Requirements 46 APPENDIX C1: VENTILATOR 47 APPENDIX C2: PATIENT AIRWAY SUCTION UNIT 49 APPENDIX C3: VOLUMETRIC PUMP 50 APPENDIX C4: SYRINGE PUMP 51 Ref: P:\Projects Database\3. Closed Projects\Med & GS - 7V0545601 Generic Spec for SPAME\Rep-6485 - 2009-0522.doc 8 © Crown Copyright Cobham Technical Services ERA Technology Report 2009-0522 APPENDIX C5: DEFIBRILLATOR 52 APPENDIX C6: PACEMAKER – EXTERNAL (Transthoracic) 53 APPENDIX C7: ECG 54 APPENDIX C8: END-TIDAL CARBON DIOXIDE MONITOR 56 APPENDIX C9: INVASIVE PRESSURE MONITOR 57 APPENDIX C10: NON-INVASIVE BLOOD PRESSURE MONITOR 58 APPENDIX C11: OXIMETER 59 APPENDIX C12: TEMPERATURE MONITOR 61 APPENDIX C13 : INTRA-CRANIAL PRESSURE MONITOR 61 APPENDIX C14: PACEMAKER – INVASIVE 63 APPENDIX C15: PERIPHERAL NERVE STIMULATOR 63 APPENDIX C16: PATIENT FORCED AIR WARMING SYSTEM 65 APPENDIX C17 GENERIC COSIDERATIONS FOR ALL TYPES OF EQUIPMENT 66 Ref: P:\Projects Database\3. Closed Projects\Med & GS - 7V0545601 Generic Spec for SPAME\Rep-6485 - 2009-0522.doc 9 © Crown Copyright Cobham Technical Services ERA Technology Report 2009-0522 Tables List Page No. Table 1: External Power Supply Voltage Types ................................................................ 16 Table 2: List of Standards Applicable ............................................................................. 34 Figures List Page No. Figure 1: CCAST Team Cube .......................................................................................... 41 Figure 2: MERT Team Cube ........................................................................................... 43 Figure 3: AEROMED Team Cube..................................................................................... 45 Ref: P:\Projects Database\3. Closed Projects\Med & GS - 7V0545601 Generic Spec for SPAME\Rep-6485 - 2009-0522.doc 10 © Crown Copyright Cobham Technical Services ERA Technology Report 2009-0522 Abbreviations List ADS Aircraft Document Set AMRE Aeromedical Role Equipment AME Airworthy Medical Equipment ASD Acceleration Spectral Density BCARs British Civil Aviation Requirements BSI British Standards Institute CAA Civil Aviation Authority COTS Commercial Off The Shelf DSCOM Defence Supply Chain Operations & Movements EMI Electromagnetic Interference EMC Electromagnetic Compatibility FAA Federal Aviation Administration FOD Foreign Object Damage GPSE General Patient Support Equipment IATA International Air Transport Association ICAO International Civil Aviation Organisation LED Light Emitting Diode M&GS Medical and General Supplies MAR Military Aircraft Release MDSS Medical Support Squadron Ref: P:\Projects Database\3. Closed Projects\Med & GS - 7V0545601 Generic Spec for SPAME\Rep-6485 - 2009-0522.doc 11 © Crown Copyright Cobham Technical Services ERA Technology Report 2009-0522 MoD Ministry of Defence NATO North Atlantic Treaty Organisation NVGs Night Vision Goggles OEC Operational Emergency Clearance PT Project Team RAF Royal Air Force RIMS Reliability Improvement Modifications RTS Release to Service RTSA Release to Service Authority SD Service Deviation SOP Standard Operating Procedures TMW Tactical Medical Wing Ref: P:\Projects Database\3. Closed Projects\Med & GS - 7V0545601 Generic Spec for SPAME\Rep-6485 - 2009-0522.doc 12 © Crown Copyright Cobham Technical Services ERA Technology Report 2009-0522 Introduction Background 4. Commercially produced medical equipment has been used on aeromedical and other military flights in both fixed-wing aircraft and helicopters for many years. However, during the introduction of the TriStar aircraft to the RAF in the air-transport role in the mid-1980s, it was recognised that none of the equipment had been specifically designed or modified for use with this aircraft. In fact, no formal clearance had been obtained for the use of such equipment on aircraft, and there was little control over what equipment was actually flown. Subsequent testing had shown that few of the equipments which were in use at the time met the normal electromagnetic compatibility requirements for airborne equipment. Furthermore, build standards and modification states often varied markedly between supposedly identical items of equipment. This led to each item of equipment being tested individually in a specific location on each aircraft type and being cleared in Military Aircraft Release (MAR) or Release To Service (RTS) documentation for use only in that location and on the basis that it generated no apparent hazard to the aircraft. No indication however was given of the margins of safety for either the patient or the aircraft. Requirement 5. Whilst the previous system of clearances offered some limited protection to the aircraft, testing and practical experience have already shown that aircraft systems can interfere with the operation of medical equipment. Furthermore, the expanding use of sophisticated electronic systems in both aircraft and medical equipment increases the likelihood of interference between them. There is therefore a need for Airworthy Medical Equipment (AME) which meets normal airworthiness requirements, reduces the potential hazards to both the aircraft and patient, and which permits a wider airframe clearance than at present. Scope 6. This specification applies to AME. The environmental and medical operational requirements for onboard and immediate aircraft vicinity only are defined in this document. The test methods for evaluation of the equipment in terms of compatibility are given in Defence Standards and standards obtainable from the British Standards Institute (BSI). Ref: P:\Projects Database\3. Closed Projects\Med & GS - 7V0545601 Generic Spec for SPAME\Rep-6485 - 2009-0522.doc 13 © Crown Copyright Cobham Technical Services ERA Technology Report 2009-0522 Mechanical, Electrical and Environmental Requirements General Considerations 7. The AME design shall be suitable to meet airworthiness standards for all year round world wide use on a wide range of fixed and rotary wing aircraft. During flight the AME shall function correctly to the specified medical performance (as defined in Annex C) and within environmental conditions defined in paragraphs 45 to 80. 8. In addition to meeting the requirements of this specification, the procurement authority shall comply with the requirements of DEF STAN 00-35 Part 1 Issue 4 Chapter 3-05 and DEF STAN 05-123 where appropriate. Mechanical Requirements General Considerations 9. The equipment casing shall be of sufficient strength to allow it to be restrained such that it shall maintain its integrity in crash conditions as defined in paragraph 59. All internal parts shall be assembled and secured so that they shall be restrained within the casing. 10. The benefits of an integrated system whether modular, add on or a fully integrated system for major components should be considered during the equipment evaluation by medical personnel. 11. Sharp corners or projections on the enclosure or doors and covers shall be avoided. The “sharpness” of such items shall meet the relevant commercial safety standards for the equipment and of the intended installation, i.e. Shall be the relevant Part of BS EN 60601-1 compliant. Doors or hinged covers shall be provided with stops or retainers to secure them in both the closed and open positions under all anticipated conditions of operation. 12. The enclosure material shall be of a corrosion resistant type or shall be suitably processed to resist corrosion when stored, transported or operated in the aeromedical role. Also it shall be effective in minimising electromagnetic emissions from internal electrical/electronic circuits and reducing susceptibility to externally generated RF fields. 13. The constructional detail of the enclosure and any openings for component parts shall be sealed to prevent fluid ingress to a minimum of IPX3, (preferably IPX4) and Ref: P:\Projects Database\3. Closed Projects\Med & GS - 7V0545601 Generic Spec for SPAME\Rep-6485 - 2009-0522.doc 14 © Crown Copyright Cobham Technical Services ERA Technology Report 2009-0522 dust ingress to IP5Y. Note that, to meet the environmental requirements set out in this specification, any gaskets used may be required to be of an electromagnetically compatible type. 14. The potential for the generation of Foreign Object Damage (FOD) either from inadvertent detachment of equipment parts or from the use of detachable probes, monitoring lines, etc is to be considered. Where appropriate, additional accountability and control of items may need to be considered as part of the supporting Standard Operating Procedures (SOP’s). Physical Characteristics 15. Controls shall be designed to ensure the settings will not be accidentally changed when the equipment is subjected to the proposed specified conditions for use (including movement or transportation whilst in operation, where appropriate). 16. The function of each control shall be identified. Displays and indicators shall be located in positions and contain appropriate levels of lighting which facilitate their readability when the equipment is operated in the proposed specified conditions for use. This should be assessed by medical personnel during the equipments initial evaluation for use in the aeromedical role. Electrical Requirements General Considerations 17. The AME shall be designed and constructed to ensure that electrical safety requirements are met for the operator, the patient and the aircraft. The former requirements are specified in parts of BS EN 60601-1 relevant to the specific equipment type, whilst the latter requirements will be specified in the individual Aircraft Type and Mark, System Specification document where appropriate. 18. Each electrically powered equipment shall be fitted with a single power on/off switch in the appropriate power line. The power supply switch should be guarded against accidental operation by the palm of a typical hand and there shall be an indication that the power supply is switched on. 19. Defence Electromagnetic compatibility (EMC) requirements are stated in paragraphs 66 to 80 inclusive, however, all medical equipment shall be CE marked to minimise the effects of electromagnetic interference (EMI), i.e. in compliance with the relevant Ref: P:\Projects Database\3. Closed Projects\Med & GS - 7V0545601 Generic Spec for SPAME\Rep-6485 - 2009-0522.doc 15 © Crown Copyright Cobham Technical Services ERA Technology Report 2009-0522 parts of EN 60601-2, equipment shall be designed so that its safety is not influenced by external electromagnetic fields as defined in this specification. Power Sources External power 20. All AME equipment which in addition to its battery supply may be powered from an external power supply shall be capable of being powered from at least one of the nominal power supply voltages shown in the following table, 24/28 V dc being the preferred supply source. The salient characteristics necessary for various external power supplies are defined in EUROCAE ED-14 and RTCA/DO-160. Table 1: External Power Supply Voltage Types Supply Type Supply Description 220/240 V, 50 Hz connection to domestic supplies (single phase) 110/115 V, 400 Hz aircraft supply 24/28 Vdc 12 Vdc aircraft supply/vehicle supply vehicle supply 21. Typically Aircraft 28 Vdc supply sockets are rated at 10 amperes (peak) and therefore future equipments current draw should be no more than this amplitude. 22. Environmental and electromagnetic tests shall be carried out with the AME operating from simulated aircraft dc supplies where appropriate. 23. Where power input selectors are employed they shall be clearly labelled so that they can be checked. Also, the power input selected shall be clearly labelled and a requirement to check the input selection by the operator is shown in the relevant equipment operating manuals. The equipment and aircraft power circuit shall be protected by readily accessible fuses or circuit breakers. The fuse ampere rating shall be labelled on or adjacent to the fuse holder. Spare fuse holders shall be labelled as such in the AME. 24. Provision shall be incorporated to protect electrical and electronic circuits from the inadvertent connection of dc power supplies with the incorrect polarity. Ref: P:\Projects Database\3. Closed Projects\Med & GS - 7V0545601 Generic Spec for SPAME\Rep-6485 - 2009-0522.doc 16 © Crown Copyright Cobham Technical Services ERA Technology Report 2009-0522 25. Where no aircraft dc supply is available a power module may be considered to be supplied by the MOD to convert the aircraft supply to 24/28 Vdc. This module shall be cleared for use on the aircraft carrying the equipment and should also include suitable interference suppression so that the aircraft safety requirements of this document are achieved. Battery Power 26. It is likely that a significant number of AME will be capable of being powered by the aircraft 28 V dc supply. These items shall incorporate internal back-up batteries to take over automatically should the 28 V power source be interrupted. The batteries shall have sufficient capacity to allow the equipment to be operated to its full specification for a minimum period defined by the use of the AME. Exchangeable batteries are permitted provided patient safety is not compromised, i.e. Where equipment batteries need to be hot swapped, then there is to be no loss of functions, settings or memory on the device during the swap. All battery types shall meet the standards required for operation on aircraft and thus be UN2800, UN3090, UN3091, UN2794, UN2795, UN3480, UN3481 or recognised specification compliant (i.e. DEF STAN 61-17). See Annex A for further details. The list of compliant batteries can be obtained from DSCOM. The “battery-low” condition shall be signalled. Alarms 27. All items of AME shall have both audible and visual alarms. Audible Alarms 28. Malfunction or electrical failure of AME should produce an audible signal and shall be capable of generating a periodic sound level in accordance with Annex E of STANAG 3204. 29. The suitability of the AME’s audio alarm levels for the intended aeromedical role, should be evaluated by the medical staff prior to procurement. Consideration of the background noise level encountered in individual platforms and function of the AME will be paramount. Visual Alarms 30. Abnormal functions and alarm indications shall be readily identifiable. All indications/displays shall be readable in all ambient light conditions from bright sunlight to total darkness. Ref: P:\Projects Database\3. Closed Projects\Med & GS - 7V0545601 Generic Spec for SPAME\Rep-6485 - 2009-0522.doc 17 © Crown Copyright Cobham Technical Services ERA Technology Report 2009-0522 Visual Displays 31. All visual displays shall be readable in all ambient light conditions from bright sunlight to total darkness. Controls should be provided with backlighting that shall be adjustable to suit ambient light conditions. 32. Visual displays should have adjustable brightness (between 0 and 100%) in line with DEF STAN 00-970 PART 1/5, SECTION 7. See paragraph 112 for further details of review requirements. Data Interfaces 33 During medical personnel’s evaluation for suitability, consideration should be made, where possible, for a data interface to enable automatic data collection. User Requirements In-Service Life 34. Each item of AME shall have an in-service life of not less than five years, from the planned Full Operating Capability Date. Confirmation that support, spare parts and the appropriate accessories will be available for the intended in-service life of the equipment will need to be obtained from the manufacturer prior to procurement. Utilisation 35. The equipment will be required to support a number of aeromedical flights per year with each flight lasting, on average six hours. All equipment should be capable of operating autonomously for a minimum period of 24 hours where applicable. 36. Evidence will be required of the equipment's capability to meet both low and high intensity utilisations. If evidence cannot be provided by the manufacturer or distributor, then clinical trials in a hospital will be required by qualified medical personnel. 37. The low intensity utilisation of the equipment has been estimated from peacetime deployment figures as nine times per annum for all items except ventilators which will be four times per annum. 38. The high intensity utilisation rates during operational aeromedical evacuations should be considered to be continuous. Ref: P:\Projects Database\3. Closed Projects\Med & GS - 7V0545601 Generic Spec for SPAME\Rep-6485 - 2009-0522.doc 18 © Crown Copyright Cobham Technical Services ERA Technology Report 2009-0522 Reliability/Configuration 39. Reliability assessment of any bespoke equipment will be carried out in accordance with Defence Standard STAN 00-40 Part 1. Reliability targets will be agreed during procurement. Commercial-Off-the-Shelf Equipment 40. It is recognised that most AME utilised will be commercial-off-the-shelf (COTS). For reliability purposes all companies from which equipment is procured shall demonstrate that the manufacturer meets ISO 9001 standards for production QA and QC. All procured equipment shall be CE marked and all AME should be trialled for no less than 3 months in a clinical environment to ensure that any reliability issues are highlighted prior to AME testing. 41. The various environmental tests applied as required by this document should show any shortcomings in the reliability of procured AME equipment not discovered during the clinical trial period. Configuration Control 42. The configuration of components and systems for AME shall be strictly controlled. Each type of equipment shall have a set build standard which shall be adhered to for items procured, plus any spares. These standards shall be agreed and set prior to commencement of production. These standards may be reviewed in light of service experience and the Company may propose Reliability Improvement Modifications (RIMs) which may be embodied subject to procurement authority agreement. However, any modification shall be embodied in all items of equipment to which it applies, plus spares, to ensure common configuration. The full cost of the RIM including any AME assessment tests shall be borne by the Contractor and full documentation must be kept to allow design traceability. Personnel Safety 43. Where the handling, servicing or operation of equipment can cause a hazard to personnel, appropriate built-in safety measures shall be defined and implemented. Safety warnings and precautions shall be stated and suitable warning notices shall be supplied. The appropriate handbooks, guides, maintenance manuals etc shall be suitably annotated. AME operating Limitations, Warnings, Cautions and Notes relevant to aircraft operating crews shall be provided in the relevant section of the aircraft MAR or RTS document and associated Aircraft Document Set (ADS). Ref: P:\Projects Database\3. Closed Projects\Med & GS - 7V0545601 Generic Spec for SPAME\Rep-6485 - 2009-0522.doc 19 © Crown Copyright Cobham Technical Services ERA Technology Report 2009-0522 Electro-Physical Requirements 44. Where the AME incorporates a clinical electro-physical performance requirement it should meet the relevant specification detailed in Annex C to this document and shall conform to IEC and British Standards appropriate to the particular equipment, as listed in Table 2. These tolerances shall also be used to define the functional failure criteria (performance requirement) for environmental and EMC susceptibility tests. Environmental Requirements 45. Environmental tests undertaken shall conform with the current edition of EUROCAE ED-14 and/or RTCA/DO-160 test methods and will apply to paragraphs 46 to 65 unless otherwise stated. Operating Temperature Range 46. The AME shall meet the specified operational performance requirements of Annex C when operated at temperatures in the range -15 °C to +60 °C in the aircraft, except where agreed by MOD. The test method will be in line with Section 5 of DO-160 as described in 45. 47. Tests will start from ambient temperature reducing to -15 ºC, stabilising for 2 hours. The temperature will then be raised to +60 °C at a rate of +2 °C per minute again stabilising for a further 2 hours. 48. Prior to procurement manufacturers should define what the failure modes are should this equipment operate outside the stated operational range and at what temperatures these modes are achieved. If this information is not available, the tolerances stated in Annex C will apply. The AME will continue to operate throughout the test cycle within the stated parameters with deviations noted within the test report. Relative Humidity 49. The AME shall suffer no deterioration of operational performance when subjected to an atmosphere where the temperature is cycled. The relative humidity for these tests is 95% ± 4% but is allowed to fall no lower than 85% when the test equipment is in the cooling cycle. This is in accordance with the Category A standard humidity environment, as stated in Section 6 of DO-160. The AME will continue to operate throughout the test cycle within the stated parameters with deviations noted within the test report. Ref: P:\Projects Database\3. Closed Projects\Med & GS - 7V0545601 Generic Spec for SPAME\Rep-6485 - 2009-0522.doc 20 © Crown Copyright Cobham Technical Services ERA Technology Report 2009-0522 Altitude/Pressure 50. The AME shall suffer no deterioration of operational performance at altitudes up to 10,000 ft or equivalent pressure (69.59 kPa). Temperature shall be recorded during this test. Depressurisation 51. The AME shall be placed in a test chamber at standard laboratory conditions of temperature, humidity and pressure. The chamber pressure is then to be reduced to a partial pressure equating to 8,000 ft (75.26 kPa) and allowed to settle for 10 minutes. 52. The chamber pressure shall be further reduced at a rate no less than 15 seconds to 20,000 ft (46.5 kPa). This reduced pressure is to be maintained for 10 minutes, then a functional assessment of the test item will be undertaken. 53. The AME is to be returned to standard atmospheric pressure within 15 minutes. 54. The AME shall continue to function to its performance specification during this test. Rapid Decompression 55. The AME shall still function following rapid decompression equivalent to an altitude of 40,000 ft (18.67 kPa) and during decompression the AME shall not affect aircraft operation. AME shall be capable of correct operation following descent to a safe altitude of 10,000 ft (69.59 kPa). The depressurisation speed will depend on the maximum rapid decompression of the chamber. 56. A functional assessment of the AME shall be undertaken after completion of the test to ensure the performance specification is still achieved. Vibration 57. AME will be used in the main fuselage area of fixed and rotary wing aircraft. During vibration tests the equipment shall be mounted in the plane/s for its intended use. The test period will last one hour and applies to each vibration axis. It shall be capable of operating in the following acceleration spectral density (ASD) levels, where g is the acceleration due to gravity: Ref: P:\Projects Database\3. Closed Projects\Med & GS - 7V0545601 Generic Spec for SPAME\Rep-6485 - 2009-0522.doc 21 © Crown Copyright Cobham Technical Services ERA Technology Report 2009-0522 Fixed Wing ASD level of 0.02 g2/Hz: Helicopter ASD 0.01 g2/Hz (Random) 0.04 g-Pk (sinusoidal), σ = 0 1.6 g-Pk (sinusoidal), σ = 0 58. Random test over the frequency range 10 Hz to 500 Hz reducing ± 6 dB per octave 500 Hz to 2,000 Hz Sine on random test (test curve G) 22 Hz 44 Hz The AME shall continue to function to its performance specification during this test. Acceleration (Crash Conditions) 59. Section 7 methodology of DO-160 / EUROCAE ED-14 will apply. Where equipment is mounted or restrained in position, the harnesses, attachments and any back up structure shall have the same standard of strength as the aircraft and shall allow achievement of the following maximum components of proof acceleration without disintegration of component parts or fittings: Forward direction: 9 (gn) Other directions : 6 (gn) Note 1: gn is the standard sea level acceleration due to gravity i.e. 9.807 m/s2 Note 2: the equipment may cease to function during and after application of the proof acceleration load Fluid Contaminant Susceptibility 60. The AME shall not be adversely affected by fluid contaminants and shall be tested in accordance with BS 3G 100 or RTCA DO 160F. The range of fluid contaminants should include aircraft hydraulic and lubricating oils, aircraft fuel and bodily fluids. Note 1: For aerospace applications the fluids are listed in BS 3G 100 Part 2 sub section 3.12 and Q Stag 362. Note 2: Tests will only be necessary for those parts where behaviour in the presence of fluid contaminants is not known. Ref: P:\Projects Database\3. Closed Projects\Med & GS - 7V0545601 Generic Spec for SPAME\Rep-6485 - 2009-0522.doc 22 © Crown Copyright Cobham Technical Services ERA Technology Report 2009-0522 Salt Mist Exposure 61. The AME shall be subjected to salt mist spray appropriate for cabin equipment or instrumentation and shall not be adversely affected by such spray or its resultant effects. The AME shall suffer no deterioration in performance when subject to a salt mist test in accordance with BS 3G 100, BS EN 60068-2-52 or equivalent test. Water-Proofness 62. Electrical and electronic components and modules shall be mounted in cases sealed against the ingress of water by spray or seepage. This should equate to a minimum requirement of meeting IPX3, but preferably IPX4 in line with EN 60529:1992. X equals sand and dust proof rating. Sand and Dust Proofing 63. Provision shall be made to exclude sand and dust from working parts and should be assessed against the requirements recommended in Section 12 of ED-14/DO-160. This assessment can be undertaken through visual inspection or through test. Should the manufacturer have already undertaken an equivalent test in line with EN 60529:1992, the IP rating for meeting this requirement is IP5Y. Y equals waterproofness rating. Shock, Drop and Topple Survivability 64. The equipment shall survive and shall be capable of fully functioning after 11 ms half sine wave shape shocks of 30 gn in each mutually perpendicular direction. 65. The equipment shall survive and shall be capable of functioning after being dropped onto its base face and also onto a corner (see BS EN 60068-2-31). Equipment which is likely to topple because of its dimensions and centre of gravity (cg) position shall survive and shall be capable of functioning after it has been toppled. Note: Conditions for equipment unlikely to topple are: 1 The ratio of the height of the cg from the base to the smaller dimension of the base is less than 0.25 then the equipment is unlikely to topple. 2 If the ratio of the height to the smaller dimension of the base is less than 0.5 then the equipment is unlikely to topple. Ref: P:\Projects Database\3. Closed Projects\Med & GS - 7V0545601 Generic Spec for SPAME\Rep-6485 - 2009-0522.doc 23 © Crown Copyright Cobham Technical Services ERA Technology Report 2009-0522 Electromagnetic Compatibility 66. Electrically powered AME shall meet the following electromagnetic compatibility requirements for airside equipment as detailed in the current issue of Defence Standard 59-411 Part 3, Annex B for the applicable equipment classification type. Radiated Tests Applicable to all AME 67. The following radiated emissions and susceptibility tests shall be applicable to all AME. Radiated Emissions 68. AME equipment shall meet the applicable radiated emission requirements as stipulated in test DRE01.B, Radiated Emissions, Electric (E)-field, over the frequency range between 50 kHz and 18 GHz, when operating in the mode deemed most likely to produce the highest emissions. 69. The applicable limits for air service use shall apply and be based on the type and size of airframe on which the AME will be utilised. If the airframe is unspecified then the Fixed Wing External and Helicopter limits shall apply. 70. Limits above 1 GHz will only apply to equipment which includes an intentionally generated signal at a frequency greater than 100 MHz. Radiated Susceptibility 71. AME shall operate within its performance specification when illuminated by an electric radiated field susceptibility environment of 10 V/m in the frequency range 10 kHz to 2 MHz and 20 V/m in the frequency range 2 MHz to 18 GHz when tested in accordance with DRS02.B, Radiated Susceptibility (E) Field. 72. The actual applied test levels shall be as stipulated below. The modulation techniques as indicated below and sweep times stated in Section 6.19.1.2 of Defence Standard 59-411 Part 3 shall be applied across relevant frequency ranges. 10 kHz to 50 kHz at 10 V/m 1) CW 50 kHz to 2 MHz at 10 V/m 1) CW 2) AM > 90% square wave at 1 kHz prf 3) 300 Hz to 3 kHz square wave AM > 90% + 1 Hz square wave modulation 90% Ref: P:\Projects Database\3. Closed Projects\Med & GS - 7V0545601 Generic Spec for SPAME\Rep-6485 - 2009-0522.doc 24 © Crown Copyright Cobham Technical Services ERA Technology Report 2009-0522 2 MHz to 30 MHz at 50 V/m 1) CW 2) AM > 90% square wave at 1 kHz prf 3) 300 Hz to 3 kHz square wave AM > 90% + 1 Hz square wave modulation 90% 30 MHz to 100 MHz at 25 V/m 1) CW 2) AM > 90% square wave at 1 kHz prf 3) 300 Hz to 3 kHz square wave AM > 90% + 1 Hz square wave modulation 90% 100 MHz to 150 MHz at 50 V/m 1) CW 2) AM > 90% square wave at 1 kHz prf 3) 300 Hz to 3 kHz square wave AM > 90% + 1 Hz square wave modulation 90% 150 MHz to 18 GHz at 50 V/m 1) CW 2) AM > 90% square wave at 1 kHz prf 3) 300 Hz to 3 kHz square wave AM > 90% + 1 Hz square wave modulation 90% (to 400 MHz) 4) 1 kHz pulse modulation. Pulse width 20 µs, switched at 1 Hz 73. The frequencies and field strengths at which deviations from the performance specification occur shall be recorded for later assessment against known transmission frequencies from the applicable airframes. Conducted Tests Applicable to AME connected to aircraft power supplies 74. The following conducted emissions and susceptibility tests shall be applied to AME equipment connected to aircraft power supplies while in operation or charging (emissions only). 75. Should AME equipment be connected to the aircraft power supply by an intermediary supply (i.e. a transformer or supply conditioner) which has an insertion loss (from both primary and secondary directions) of 40 dB or greater over the frequency range 50 kHz to 400 MHz, then only Low Frequency Conducted Susceptibility tests as defined in line 78 shall be applied. Ref: P:\Projects Database\3. Closed Projects\Med & GS - 7V0545601 Generic Spec for SPAME\Rep-6485 - 2009-0522.doc 25 © Crown Copyright Cobham Technical Services ERA Technology Report 2009-0522 76. Intermediary supplies which utilize active electronics shall be tested to all conducted test requirements of Defence Standard 59-411 Part 3, Annex B applicable for air service, in addition to meeting the requirement for insertion loss stated in 75. Conducted Emissions 77. AME shall meet the applicable conducted emission requirements as stipulated in DCE01.B conducted emission on primary power lines (limit for air service use), over the frequency range between 20 Hz and 150 MHz. The AME will be operated in the mode deemed most likely to produce the highest emissions. Conducted Susceptibility (Low Frequency) 78. AME shall operate within its performance specification when subjected to the conducted susceptibility requirements as stipulated in DCS01.B, conducted susceptibility on primary power lines, over the frequency range between 20 Hz and 50 kHz. Conducted Susceptibility (High Frequency) 79. AME shall operate within its performance specification when subject to the conducted susceptibility requirements as stipulated in DCS02.B over the frequency range 50 kHz and 400 MHz. This test shall be applied to primary power lines only, utilising the accept/reject limit (A) stated for air service use, with the maximum cable bundle current being limited to 100 mA. Electrostatic Discharge 80. AME shall operate within its performance specification when subject to the effects of static electricity and shall meet the requirements of DCS10.B, electrostatic discharge, at a level of ± 8 kV (± 15 kV for non conducting surfaces) also taking into consideration the specific requirements of Section 9.13 of Defence Standard 59-411 Part 3. COMPATIBILITY AND STANDARDIZATION 81. Where appropriate, all AME shall be compatible with aeromedical role equipment (AMRE) and general patient support equipment (GPSE) in current use. Ref: P:\Projects Database\3. Closed Projects\Med & GS - 7V0545601 Generic Spec for SPAME\Rep-6485 - 2009-0522.doc 26 © Crown Copyright Cobham Technical Services ERA Technology Report 2009-0522 82. Any equipment requiring modification to meet AMRE or GPSE shall require confirmation from Medical and General Supplies Team (M&GS Team) & Tactical Medical Wing (TMW) that such modifications are feasible prior to procurement. 83. Aeromedical Role Equipment (AMRE) comprises the aircraft fixtures and fittings, specific to the aircraft type, that are required to enable patients and medical equipment to be carried in a suitable way during flight. Examples of AMRE are: a. stretcher posts, support straps and stanchions b. stretcher support frames c. stretcher privacy fitments (VC10 and TriStar only) d. restraint equipment (strops 'O' rings and 'D' rings) 84. General patient support equipment (GPSE) comprises the basic medical materiel required to tend and carry patients in flight in a safe and appropriate manner. Examples of GPSE are: a. flight nursing attendant pannier b. therapeutic oxygen cylinders c. patient comforts bag d. stretcher complete (including harness) SUPPORT PUBLICATIONS 85. Each equipment shall be supplied complete with the following publications as separate items: a. User Handbook/ Operators Manual b. Illustrated Parts List c. Workshop Manual/Maintenance Manual d. Drawings and subsequent drawing amendments 86. The style of these publications shall be in the appropriate publications format or as agreed by the Authority with the distributor/manufacturer. Ref: P:\Projects Database\3. Closed Projects\Med & GS - 7V0545601 Generic Spec for SPAME\Rep-6485 - 2009-0522.doc 27 © Crown Copyright Cobham Technical Services ERA Technology Report 2009-0522 REQUIREMENTS AUTHORITIES OF AIRCRAFT DESIGN AND TECHNICAL ELECTRICAL INTERFACE REQUIREMENTS 87. Power supply cables for the AME shall be fitted at the aircraft power supply interfacing end with connectors which are compatible with the connectors in the aircraft. The power cable shall be of at least twin screened flexible armoured SY type. 88. Socket will be accordance with the M&GS Team requirements. The electrical characteristics of the power supplies on the aircraft are given in BS 3G100-3. 89. Electrical interface requirements for non-aircraft utilisation should follow the general guidance specified in CEN/TC 239/WG5 N 42 entitled "Air, water and difficult terrain ambulances - Medical devices for the continuity of patient care". 90. All modifications to power leads will be undertaken by aeromed qualified MDSS technicians. MECHANICAL INTERFACE REQUIREMENTS 91. The mechanical interface requirements for aircraft utilisation should follow the general guidance specified in BS EN 13718-1 and EN 13718-2. REQUIREMENTS OF MAINTENANCE AUTHORITIES 92. The MOD has its own technicians trained in the maintenance of medical equipment. These technicians shall be responsible for fault diagnosis and the repair and adjustment of AME as authorised by the support authority. This will involve such operations as the replacement of connectors, indicators, circuit boards and readily accessible components. The manufacturer / distributor shall be requested to provide: a. Maintenance manuals containing components lists, circuit diagrams, assembly diagrams, test data and calibration instructions b. Lists of special purpose test equipment which are required for the maintenance function at the defined level c. Advice on holdings of replacement parts d. Courses of training in the maintenance of any equipment(s) of such complexity as to require special instruction Ref: P:\Projects Database\3. Closed Projects\Med & GS - 7V0545601 Generic Spec for SPAME\Rep-6485 - 2009-0522.doc 28 © Crown Copyright Cobham Technical Services ERA Technology Report 2009-0522 e. Procedures for maintaining the EMC integrity of the AME should be provided so that maintenance shall not degrade the performance of EMI shields/filters/gaskets etc. f. Information on lifted items, gases or hazardous materials. CONFIGURATION CONTROL AND POST DESIGN STANDARD REQUIREMENTS CONFIGURATION CONTROL 93. In order to ensure that the required electro-physical and environmental characteristic performances are maintained throughout the life cycle for all the equipment assessed against the AME criteria, it is essential that a configuration management policy be established. All changes from a specified baseline shall be controlled using a formal procedure. This should allow the maximum degree of latitude for use by medical staff in flight but also introduce sufficient configuration control necessary for maintenance, interoperability and logistic support. 94. The timing and extent of configuration management shall be agreed with the MOD Project Office with regard to its scope, complexity and life cycle phase of the equipment. It shall be applicable to any spares, tools, test equipment and technical documentation. 95. Modification instructions which will change the performance characteristics or replace obsolescent/obsolete parts, shall be agreed by the authority and formally issued. Where necessary these shall be accompanied with a modification kit. IN-SERVICE REQUIREMENTS 96. During the in-service phase of an equipment life cycle, only manufacturer approved maintenance and repair procedures shall be employed. All replacement parts and their installation shall be as specified in the manufacturers maintenance documentation. 97. Changes in electrical or mechanical design which could in any way have an impact on the EMC or environmental characteristics of the AME must be communicated to the relevant MoD maintenance body. The design changes will then be evaluated by an independent body to assess the actual impact on the EMC and environmental characteristics of the AME. Ref: P:\Projects Database\3. Closed Projects\Med & GS - 7V0545601 Generic Spec for SPAME\Rep-6485 - 2009-0522.doc 29 © Crown Copyright Cobham Technical Services ERA Technology Report 2009-0522 APPLICABILITY OF STANDARDS UK/International Standards 98. A number of applicable UK Defence Standards have been identified in this specification along with a small number of British and International Standards. These Standards are listed in Table 2. SAFETY CASE ASSESSMENT REPORTING General Considerations 99. All benchmark tests undertaken on the AME in line with this specification are in consideration of threats to aircraft or patient safety. 100. Testing shall be undertaken by qualified test houses, which are independent from the assessing body as required by JSP 553. 101. Under the circumstances of test failures, mitigation arguments can only be used by assessing bodies if full and comprehensive qualifications are presented. Possible implications for different airframes should also be highlighted and summarised in a summary/conclusions section of the safety case. 102. All test house results and reports should accompany each AME safety case as appendices to support and show evidence for the technical arguments made by the assessing body. 103. NATO Stock Numbers where allocated shall be displayed on the front cover of any safety case report issued. Aircraft Safety 104. These are tests which relate to possible interference to critical avionic, communication, defensive aids and navigation systems. The tests which are considered critical to aircraft safety are as follows: a. Radiated Emissions b. Conducted Emissions. Ref: P:\Projects Database\3. Closed Projects\Med & GS - 7V0545601 Generic Spec for SPAME\Rep-6485 - 2009-0522.doc 30 © Crown Copyright Cobham Technical Services ERA Technology Report 2009-0522 Patient Safety 105. These are tests which relate the possible threats to the normal operation of the AME from external EMI and Environmental phenomena. These relate to those phenomena encountered in most airframes. The tests which are considered critical to patient safety are as follows: a. Radiated Susceptibility b. Conducted Susceptibility (Low and High Frequency) c. Electrostatic Discharge d. Operating Temperature Range e. Relative Humidity f. Altitude/Pressure g. Depressurisation h. Rapid Decompression i. Vibration j. Acceleration (Crash Conditions) k. Water-Proofness l. Sand and Dust Proofing m. Shock, Drop and Topple Survivability. Evaluation / Safety Case Considerations 106. Failure to meet test limits without proper mitigation qualification may result in the equipment not being recommended for use as AME. 107. Some of the tests listed in paragraphs 108, 109 and 110 can be assessed from manufacturers supplied data where there is equivalence between the applied test regime. 108. The following patient safety tests should be considered and assessed prior to aeromedical use. All other tests can use mitigation or qualification arguments as part of the evaluation and the appropriate condition of use procedure written. a. Radiated Susceptibility b. Conducted Susceptibility (Low and High Frequency) Ref: P:\Projects Database\3. Closed Projects\Med & GS - 7V0545601 Generic Spec for SPAME\Rep-6485 - 2009-0522.doc 31 © Crown Copyright Cobham Technical Services ERA Technology Report 2009-0522 c. Electrostatic Discharge d. Vibration e. Altitude/Pressure f. Depressurisation g. Operating temperature. 109. Handheld devices may have special dispensation for Vibration tests under the condition that they will not encounter the level of vibration which may be appropriate to other equipment. The assessing body would have to evaluate if this is the case in practice. 110. It is recognised that certain equipment (i.e. ventilators) may require special protection under some harsh environmental conditions but still be suitable as AME. Thus the following tests may be assessed via visual inspection of the equipments build standard and apertures and the appropriate mitigation recommendations for use in the AME role shall be made. Reference to manufacturers information can also be made in some instances. a. Water-Proofness b. Sand and Dust Proofing c. Shock, Drop and Topple Survivability d. Relative Humidity e. Fluid Contaminant Susceptibility f. Salt Mist Exposure Additional Considerations 111. The Safety Case will specifically consider the suitability of the type of batteries used with the AME, whether they be fixed or removable. This will be undertaken via a paper review of the type of battery utilised verses the requirements of DEF STAN 6121 and Annex A of this document and the Current IATA regulations. Manufacturer’s data where applicable can be used in this review. 112. Consideration of the effect of the AME on Night Vision Goggles shall be required as part of the Safety Case with recommended mitigation (if required) clearly stated. The primary considerations are: a) NVG compatibility of displays and LED indicators Ref: P:\Projects Database\3. Closed Projects\Med & GS - 7V0545601 Generic Spec for SPAME\Rep-6485 - 2009-0522.doc 32 © Crown Copyright Cobham Technical Services ERA Technology Report 2009-0522 b) Practical use of the AME by medical personnel c) Airframe type where equipment will be utilised d) Whether displays can be reflected in the cockpit windows Release to Service Documentation 113. Every item of AME requires inclusion in the Release to Service (RTS) document in the list of cleared Aeromedical Role Equipment prior to being cleared for flight. The Release to Service Authority (RTSA) requires a Safety Case Report prepared in accordance with the requirements of DEF STAN 00-56 and a supporting set of RTS Recommendations, which are specific to each Aeromedical capable aircraft type, before an amendment can be authorised to the RTS. 114. The Safety Case Report (based on the data forthcoming from the testing for compliance with the standards stated in this document) must highlight any hazards, along with appropriate mitigation and associated level of risk. This information must be reflected in the RTS Recommendations, along with any Warnings, Cautions or Limitations specific to each individual aircraft type. 115. A process exists within the Generic Aircraft Release Process (GARP) for providing an Operational Emergency Clearance (OEC) or a Clearance with Limited Evidence (CLE) (Previously known as a Service Deviation (SD) for legacy format RTS) as described in JSP 553. Requests for such clearances will be considered by the RTSA on a case-bycase basis. Post Clearance Modified Equipment 116. Equipment which has been cleared for use as AME should have tests repeated if there are electrical or mechanical changes to the AME’s design. The assessing body should discuss with the M&GS Team or MoD representative body the appropriate tests (if any) required for re-evaluation. 117. Safety case reports for modified equipment shall either be reissued as a subsequent issue document or as an addendum to the existing safety case. Ref: P:\Projects Database\3. Closed Projects\Med & GS - 7V0545601 Generic Spec for SPAME\Rep-6485 - 2009-0522.doc 33 © Crown Copyright Cobham Technical Services ERA Technology Report 2009-0522 Table 2: List of Standards Applicable Number Title DEF STAN 00-42 Part 4 Reliability and Maintainability (R&M) Assurance Guide – Testability DEF STAN 00-35 Environmental handbook for defence materiel DEF STAN 00-40 Reliability and maintainability DEF STAN 00-56 Safety Management Requirements for Defence Systems DEF STAN 05-123 Technical procedures for the procurement of aircraft, weapon and electronic systems DEF STAN 00-970 Design requirements for Service aircraft DEF STAN 68-284 Compressed Breathing Gases for Aircraft, Diving and Marine LifeSupport Applications DEF STAN 59-411 Electromagnetic compatibility DEF STAN 61-21 series General specification for batteries DEF STAN 61-17 The requirements for the selection of batteries for Service equipment DEF STAN 66-31 Basic requirements and tests for proprietary electronic and electrical test equipment BS EN 60068-2 Environmental testing: Test methods BS 2G 239 Specification for primary active lithium batteries for use in aircraft BS 3G 100 Environmental testing of all equipment used in aircraft BS 2011 Environmental testing EN 60601-1 series, BS Medical electrical equipment series. General requirements for safety. 5724 IEC 513 Fundamental aspects of safety standards for medical electrical equipment BS EN ISO 10079-1 Medical suction equipment. Electrically powered suction equipment. Safety requirements RTCA/DO-160 Environmental equipment conditions and test procedures for airborne EUROCAE ED-14 Environmental equipment conditions and test procedures for airborne MDD 93/42/EEC European Union medical device directive EN 60601-1-2 Medical electrical equipment. General requirements for basic safety and essential performance. Collateral standard. Electromagnetic compatibility. Requirements and tests Ref: P:\Projects Database\3. Closed Projects\Med & GS - 7V0545601 Generic Spec for SPAME\Rep-6485 - 2009-0522.doc 34 © Crown Copyright Cobham Technical Services ERA Technology Report 2009-0522 BS EN 13718-1 Medical vehicles and their equipment. Air ambulances. Requirements for medical devices used in air ambulances QSTAG 362 Chemical Environmental Contaminants affecting the Design of Military Material. EN 60529 Specification for degrees of protection provided by enclosures (IP code) Ref: P:\Projects Database\3. Closed Projects\Med & GS - 7V0545601 Generic Spec for SPAME\Rep-6485 - 2009-0522.doc 35 © Crown Copyright Cobham Technical Services ERA Technology Report 2009-0522 ANNEX LIST ANNEX A DANGEROUS GOODS AND AIR AMBULANCE FLIGHTS ANNEX B TEAM CUBE ANNEX C EQUIPMENT CLINICAL CAPABILITY Ref: P:\Projects Database\3. Closed Projects\Med & GS - 7V0545601 Generic Spec for SPAME\Rep-6485 - 2009-0522.doc 36 © Crown Copyright Cobham Technical Services ERA Technology Report 2009-0522 ANNEX A: DANGEROUS GOODS AND AIR AMBULANCE FLIGHTS General Comments 118. Dangerous goods are to be transported within military regulations (JSP 335 Dangerous Air Cargo Regulations) as well as the civilian Dangerous Goods Regulations produced by the International Air Transport Organisation (IATA). The IATA regulations are based on the International Civil Aviation Organisations Technical Instructions for the Safe Transport of Dangerous Goods by Air, but incorporate additional operational requirements, which provide a harmonized system for all operators to accept and transport dangerous goods safely and efficiently by air. JSP 335 takes its lead from the IATA regulations and will only allow specific exemptions from IATA which all have to be approved by the Dangerous Goods by Air Committee, which is an arm of Defence Supply Chain Operations & Movements (DSCOM). 119. All medical gas cylinders are classed as Dangerous Goods. All gas cylinders used for medical purposes by the UK military are supplied by the Defence Fuels Group with the approval of the M&GS Team. All these cylinders meet the required standard for transporting dangerous goods. 120. DSCOM has recently issued guidance for the use or carriage of lithium batteries on airframes (DSCOM/DMTPD/4302/34, 4th Dec 2008) which notes specific documentation and marking requirements of Lithium based cells. DSCOM however, should be consulted about the use or marking of 'wet cell or lithium batteries' where there is any confusion over requirements. 121. DSCOM should be informed of all potential Dangerous Air Cargo requirements, and the necessary agreements/dispensations should be obtained, including any requirement for JATEU trials, preparation procedures and/or tie down schemes, at the earliest opportunity. 122. The MAR or RTS documentation shall consider the following list of factors (where appropriate) when making recommendations:a. Definition of operating environment for the proposed military deployment b. Critical duties for batteries c. Consequences of battery failure d. Indication as to whether spares may be required and if in flight exchange is permitted Ref: P:\Projects Database\3. Closed Projects\Med & GS - 7V0545601 Generic Spec for SPAME\Rep-6485 - 2009-0522.doc 37 © Crown Copyright Cobham Technical Services ERA Technology Report 2009-0522 e. Material Safety data – statement of chemical constituents / leakage precautions / fire fighting measures. 123. The following list of information shall be obtained where appropriate to support the MAR or RTS Safety Case. a. Identification of each battery including detail on component cells b. NATO Codification c. Manufacturers operational limits for the battery (temperature/humidity etc) d. Details of inbuilt protective devices e. Whether the batteries have already been assessed against IATA requirements. f. Any record of safety tests applied to the battery (e.g. BS EN 60086-4, BS EN 60086-5, UL 1642) Flight requirements and storage 124. All dangerous goods (including those transported under the exemption rules) are to be packaged, marked and labelled in compliance with the IATA regulations. Compliance with IATA regulations allows dangerous goods to be transported on either military or civilian aircraft. 125. All dangerous goods carried for use-in-flight by medical personnel are to be controlled under the direct supervision of suitably competent personnel at all times whilst on an aircraft. This includes a requirement for secure stowage. 126. The pilot-in-command of an aircraft is to be informed of all dangerous goods carried on that aircraft. Additionally, flight crews and other employees (such as ground handling teams) need to be aware of the presence of dangerous goods to allow them to carry out their specific responsibilities. 127. The operator must provide information to employees so as to enable flight crews and other employees to carry out their responsibilities with regard to dangerous goods. This information must include: (a) The action to be taken in the event of emergencies involving dangerous goods; (b) Details of the location and identification of cargo holds. Ref: P:\Projects Database\3. Closed Projects\Med & GS - 7V0545601 Generic Spec for SPAME\Rep-6485 - 2009-0522.doc 38 © Crown Copyright Cobham Technical Services ERA Technology Report 2009-0522 Exceptions 128. These regulations do not apply to dangerous goods carried on aircraft where the dangerous goods are: (a) placed on-board with the approval of the operator to provide medical aid to a patient during flight. (b) to provide aid in connection with search and rescue operations during flight. Goods Acceptable with Operator Approval, as Checked Baggage Only. (i) Wheelchairs/Mobility Aids with Non-Spillable batteries. (ii) Wheelchairs/Mobility Aids with Spillable batteries. Goods Acceptable with Operator Approval, as Carry-On Baggage Only. (i) Mercury Barometer or Thermometer. Goods Acceptable with Operator Approval, as Baggage. (i) Medical Oxygen. Small gaseous oxygen or air cylinders required for medical use. (ii) Avalanche Rescue Backpack. Goods Acceptable without Operator Approval (as baggage). (i) Medicinal or Toilet Articles. (ii) Non-radioactive medicinal or toilet articles. The term 'medicinal' is intended to include such items as medicines containing alcohols. (i) Cylinders for mechanical limbs. (ii) Cardiac Pacemakers / Radio-pharmaceuticals. (iii) Medical/Clinical thermometer. Other exceptions include Medical or Clinical Wastes or the loading of Wheelchairs or other battery Operated Mobility Aids as Checked Baggage. Ref: P:\Projects Database\3. Closed Projects\Med & GS - 7V0545601 Generic Spec for SPAME\Rep-6485 - 2009-0522.doc 39 © Crown Copyright Cobham Technical Services ERA Technology Report 2009-0522 ANNEX B: THE TEAM CUBE INTRODUCTION 129. This section provides background information and guidance on the Patients, Team, Equipment, ‘Team Cube’ concept for each of the three AME team types. The intent is to provide information for potential suppliers so that they are aware of the team limitations associated with the number of available personnel free to move patients and equipment on and off different modes of transport, thus enabling future design specifications to take account of equipment use thereby increasing capabilities. Critical Care Air Support Team (CCAST) - TEAM CUBE 130. CCAST Definition – CCAST comprises of RAF Medical Personnel who fill full-time posts and typically consists of: • Consultant anaesthetist (Intensive Care Unit) (ICU)), • Registered Nurse(Adult) (RN(A))(ICU) (Flight Nurse) (FN) • Flight Nursing Officer(FNO) • RAF Medic(Flight Nursing Attendant) (FNA) • Medical & Dental Servicing Section Technician ( MDSS Tech) 131. The aim of the CCAST is: to provide in-flight medical care, utilising multidisciplinary team members to affect the rapid, expedient and safe transfer of critically ill patients by air from any location worldwide; whilst providing training, when applicable, for junior medical multidisciplinary staff whilst maintaining logistic and governance process. 132. The CCAST Team Cube illustrated in Figure 1 gives a pictorial representation on the configuration of a stretcher patient the medical attendees and equipment that “moves” as a unified item or “Cube” when patient transfers are undertaken between different modes of transport throughout the repatriation chain. 133. Note that the stretcher can be moved by non medical personnel at the air head depending on their availability such as movements staff and fire rescue personnel, however the assumption cannot be made that these personnel will be available 134. The items outside of the dashed line /shaded area are considered as being able to be moved separately to the immediate patient transfer but still being available for use. Ref: P:\Projects Database\3. Closed Projects\Med & GS - 7V0545601 Generic Spec for SPAME\Rep-6485 - 2009-0522.doc 40 © Crown Copyright Cobham Technical Services ERA Technology Report 2009-0522 135. The purpose of the illustration is to highlight the weight bearing limitations of the CCAST Team to concurrently transfer the patient and all the equipment as a single entity in a safe manner. Ventilator Critical Care Stretcher with Backrest Monitoring/ Defibrillation Stabilisation mattress Pacing Pressure Relieving mattress Volumetric infusion/PCAS Patient temperature regulation Fluid Warming Wound vacuum Drug Infusion x 6 Emergency Drugs & eqpt (BVM) Airway suction Peripheral Nerve stimulation Blood gas analysis Electronic stethoscope Consumables Equipment packaging ICPM Patient/team personal baggage Medical gas Clinical waste Chest Drain Waste fluids kits Patient & Team IPE: Combat Body Armour Weapons/Ammunition Helmet Figure 1: CCAST Team Cube Ref: P:\Projects Database\3. Closed Projects\Med & GS - 7V0545601 Generic Spec for SPAME\Rep-6485 - 2009-0522.doc 41 © Crown Copyright Cobham Technical Services ERA Technology Report 2009-0522 Medical Emergency Response Teams - TEAM CUBE 136. 137. The MERT Team comprises of 2 Clinicians which will care for up to 4 critical care patients concurrently and typically consists of: • Registered Nurse (Adult) (Emergency Medicine) RN(A) (EM) • RAF Medic (Paramedic) These may be supplemented for MERT Enhanced (MERT (E)) operations by: • Medical Officer ( MO) with specific competencies in Pre-Hospital Emergency Care (PHEC) • An additional RAF Medic (non paramedic) 138. The Aim of the MERT is to provide medically controlled evacuation, normally be rotary wing aircraft of patients as far forward as the tactical situation permits, to the first echelon of medical care. MERT is the medical component of an Inident response Team and is used when the clinical situation dictates the requirement for PHEC clinical intervention during the transit of casualties from the point of wounding (POW) to the appropriate Medical Treatment Facility (MTF) MERT operate throughout the evacuation chain and can be tasked to provide support to special forces (SF) and hence need to be light and agile in capability. The PHEC capability is provided through the means of appropriately trained, Qualified and equipped Paramedics and Emergency Medicine Nurses. 139. MERT May be augmented to provide an enhanced capability known as MERT Enhanced (MERT (E)). The augmentation is by the addition of a Medical Officer (MO) with specific competencies in Pre-hospital and Emergency Care and A Qualified AE RAF Medic. MERT (E) adds additional dimensions to the MERT response with the MO’s ability to undertake specific procedures which include advanced airway management, Rapid sequence Induction, maintaining anaesthesia and exercising a greater degree of clinical judgement. The Decision for MERT (E)( deployment is based on detailed reports of the casualty needs and condition. 140. The MERT Team Cube illustrated in Figure 2 gives a pictorial representation on the configuration of a stretcher patient the medical attendees and equipment that “moves” as a unified item or “Cube” when patient transfers are undertaken between different modes of transport throughout the repatriation chain. Ref: P:\Projects Database\3. Closed Projects\Med & GS - 7V0545601 Generic Spec for SPAME\Rep-6485 - 2009-0522.doc 42 © Crown Copyright Cobham Technical Services ERA Technology Report 2009-0522 141. The items outside of the dashed line /shaded area are considered as being able to be moved separately to the immediate patient transfer but still being available for use. 142. The purpose of the illustration is to highlight the weight bearing limitations of the MERT Team to concurrently transfer the patient and all the equipment as a single entity in a safe manner. Ventilator Basic Stretcher Airway suction Monitoring Patient temperature regulation Electronic stethoscope Defibrillation Consumables Medical gas Pacing Equipment packaging Patient items incl: Fluid Warming Weapons/ ammunition Combat Armour Helmet Patient/team personal baggage Figure 2: MERT Team Cube Ref: P:\Projects Database\3. Closed Projects\Med & GS - 7V0545601 Generic Spec for SPAME\Rep-6485 - 2009-0522.doc 43 © Crown Copyright Cobham Technical Services ERA Technology Report 2009-0522 AEROMED TEAM CUBE 143. The AEROMED Team comprises of a variable number of Clinicians which will care for up to 40 patients concurrently (for planning purposes one team of 10- personnel comprising 1 x GP (GMP), 1 x FNO , 4 x FN & 4 x FNA will be capable of escorting 40 patients per lift). 144. Typically Teams consist of any of the following disciplines or combinations thereof: • • Registered Nurse ( Flight Nurse, Flight Nursing Officer), RAF Medic (Flight Nursing Assistant) • Registered Nurse (Mental Health) • Aeromed Teams provide the non critical medical repatriation of military personnel and entitled civilians from any location world wide both strategic and tactical. o Strategic provides for the Aeromedical evacuation of patients to the UK or other allied country or safe area out of the theatre of operations o Tactical ( not MERT & MERT E) provides for the Aeromedical evacuation for patients between Medical Treatment Facilities within the theatre of operations 145. The Aeromed Team Cube illustrated in Figure 3 gives a pictorial representation on the configuration of a stretcher patient the medical attendees and equipment that “moves” as a unified item or “Cube” when patient transfers are undertaken between different modes of transport throughout the repatriation chain. 146. The items outside of the dashed line /shaded area are considered as being able to be moved separately to the immediate patient transfer but still being available for use. 147. The purpose of the illustration is to highlight the weight bearing limitations of the AEROMED Team to concurrently transfer the patient and all the equipment as a single entity in a safe manner. Ref: P:\Projects Database\3. Closed Projects\Med & GS - 7V0545601 Generic Spec for SPAME\Rep-6485 - 2009-0522.doc 44 © Crown Copyright Cobham Technical Services ERA Technology Report 2009-0522 Stretcher Airway suction Pressure Relieving Mattress Monitor Defib Battery bag Medical gases SKAI Bags Drug infusion Intravenous infusion Drains and Catheter Consumables Equipment packaging Patient/team personal baggage Figure 3: AEROMED Team Cube Ref: P:\Projects Database\3. Closed Projects\Med & GS - 7V0545601 Generic Spec for SPAME\Rep-6485 - 2009-0522.doc 45 © Crown Copyright Cobham Technical Services ERA Technology Report 2009-0522 ANNEX C: EQUIPMENT CLINICAL CAPABILITY INTRODUCTION 148. This requirement for AME defines the capability of equipment which provides monitoring and life support during patient transportation by air. 149. AME is required to maintain its electro-physical performance when subjected to the environmental conditions experienced in the aeromedical role. Additionally, design should ensure that the full air worthiness standard is achieved, allowing the AME to be flown in any aircraft without recourse to special flight trials. Electro-Physical Requirements The electro-physical performance requirements are in Appendixes C1 to C16 inclusive. Monitoring parameters Appendices C7-13 may be included with other capabilities in multifunction device. Capability at Appendices C5 and 6 should be included in the same device. Generic consideration for all equipment is at Appendix C17. Further details of the current equipment capability requirements are stated in Annex A of 20090804_AME_SRD. Requirement Appendix Adult Ventilator Appendix C1 Patient Airway Suction Unit Appendix C2 Volumetric Pump Appendix C3 Syringe Pump Appendix C4 Defibrillator Appendix C5 Pacemaker - External Appendix C6 Electrocardiograph Appendix C7 End Tidal Carbon Dioxide Monitor Appendix C8 Invasive Pressure Monitor Appendix C9 Non-invasive Blood Pressure Monitor Appendix C10 Ref: P:\Projects Database\3. Closed Projects\Med & GS - 7V0545601 Generic Spec for SPAME\Rep-6485 - 2009-0522.doc 46 © Crown Copyright Cobham Technical Services ERA Technology Report 2009-0522 Oximeter Appendix C11 Temperature Monitor Appendix C12 Intra-Cranial Pressure Monitor Appendix C13 Pacemaker – Invasive Appendix C14 Peripheral Nerve Stimulator Appendix C15 Patient Forced Air Warming System Appendix C16 Generic Considerations for Equipment Appendix C17 APPENDIX C1: VENTILATOR 1. Portable intensive care ventilator not requiring compressed air and capable of utilising low or high pressure oxygen. 2. Paediatric/Adult capability 3. Examples of Modes: Volume control, pressure control, SIMV, pressure support, CPAP + pressure support, PEEP, non invasive, tube compensation (for spontaneous breathing), nebulised drugs humidification. 4. Ranges: a. Tidal Volume: 0.4-1 litre b. Rate: 0-50 breaths/min [0-50 Hz] c. Inflation pressure: 0 - 90 cms water pressure d. Inspiratory flow: 10-100 litres/min e. PEEP: 0-20 cms water pressure f. 5. Assist sensitivity: 0-9 litres per minute (flow triggered) Accuracy: a. Tidal volume: ±10% b. Rate: ±1 c. Inflation pressure: ±5% Ref: P:\Projects Database\3. Closed Projects\Med & GS - 7V0545601 Generic Spec for SPAME\Rep-6485 - 2009-0522.doc 47 © Crown Copyright Cobham Technical Services ERA Technology Report 2009-0522 6. Display a. Tidal volume b. Rate c. I/E ratio d. Airway pressure (mean and peak) e. Inspired oxygen concentration f. Expired tidal and minute volume g. PEEP h. Sensitivity i Pressure Control j. Pressure Support k. Mode selected l. Control Lock m. Alarm settings n. Power source o. Patient trigger 7. Controls: a. Mode b. Volume c. Rate d. I/E ratio (may be controlled by setting inspiratory time) e. Inspired oxygen concentration in 1% increments from 21% to 100% g. Upper and Lower inflation pressure limits h. Assist sensitivity i. PEEP level p. Ventilatory cycle Ref: P:\Projects Database\3. Closed Projects\Med & GS - 7V0545601 Generic Spec for SPAME\Rep-6485 - 2009-0522.doc 48 © Crown Copyright Cobham Technical Services ERA Technology Report 2009-0522 8. Alarms: a. Low/High inflation pressure b. Apnoea (automatic default to apnoea settings) c. Low inspired oxygen concentration d. Low expired minute volume e. Failure of gas supply f. Ventilator failure g. Self test failure h. High PEEP i. Change of power supply j. Low power k. Loss of power l. 9. Switch off Power Supply: See Appendix C17 APPENDIX C2: PATIENT AIRWAY SUCTION UNIT 1. Variable suction capability, 40-500 mmHg 2. Free flow on suction over 25 l/min 3. Collection vessel: disposable 4. Mechanism to prevent atmospheric contamination. 5. Suction unit shall be protected from contamination by collection vessel contents. 6. Not dependent on oxygen supply for function. 7. When in continuous use with a battery the unit shall function for at least 45mins at free flow rates. 8. Display a. Illuminated indicators to show: on, battery low, charging b. Vacuum gauge Ref: P:\Projects Database\3. Closed Projects\Med & GS - 7V0545601 Generic Spec for SPAME\Rep-6485 - 2009-0522.doc 49 © Crown Copyright Cobham Technical Services ERA Technology Report 2009-0522 c. Fault 9. Controls a. On/off b. Vacuum regulation 10. Power: See Appendix C17 APPENDIX C3: VOLUMETRIC PUMP 1. Rate: 0.1 - 999 mls/hour in 0.1 ml increments, occlusion pressure to cover full range of patient types – Accuracy ± 5%. Able to deliver more than one infusion concurrently. 2. Flow duration selectable both fixed quantity or fixed rate and must be capable of delivering full range of fluids (crystalloid, therapeutics, whole blood). Giving sets to be disposable. 3. Display: a. Flow rate b. Accumulated volume delivered c. Pump running indicator d. Battery remaining indicator e. Advisory/actual alarm symbols f. Bolus/secondary infusion rate g. Occlusion pressure settings 4. Controls: a. On/Off b. Start/Stop c. Menu d. Programming e. Alarm silence/Reset Ref: P:\Projects Database\3. Closed Projects\Med & GS - 7V0545601 Generic Spec for SPAME\Rep-6485 - 2009-0522.doc 50 © Crown Copyright Cobham Technical Services ERA Technology Report 2009-0522 5. Alarms - audio/visual to indicate: a. Incorrect programming b. Overpressure c. Infusion near completion d. Infusion complete e. Power On Self Test/Pump failure f. Air in line g. Battery low h. Battery failed 6. Power supply: See Appendix C17 APPENDIX C4: SYRINGE PUMP 1. Rate: 0.1-100 mls/hour in 0.1 ml increments - Accuracy ± 2% 2. Syringe size (20 & 50-60 mls) and model selectable 3. Display: a. Flow rate b. Accumulated volume/Volume to be Infused c. Pump running indicator d. Loaded syringe size e. Battery remaining indicator f. Advisory/actual alarm symbols g. Bolus rate h. Occlusion pressure settings 4. Controls: a. On/Off b. Start/Stop c. Menu Ref: P:\Projects Database\3. Closed Projects\Med & GS - 7V0545601 Generic Spec for SPAME\Rep-6485 - 2009-0522.doc 51 © Crown Copyright Cobham Technical Services ERA Technology Report 2009-0522 d. Programming e. Alarm silence/Reset 5. Alarms - audio/visual to indicate: a. Incorrect programming b. Overpressure c. Infusion nearly complete d. Infusion complete e. Disengaged syringe f. Power on self test/ pump failure g. Battery low h. Battery failed 6. Power supply: See Appendix C17 APPENDIX C5: DEFIBRILLATOR 1. Waveform: Bi-phasic suitable neonatal to adult, internal and external capability desirable 2. Output energy: 0-360 Joules, increments variable, to comply with prevailing Resuscitation Council Guidelines – Accuracy ± 5% at 200 Joules. 3. Charge time: less than 10 secs to 360 Joules 4. Battery power: Minimum of 100 shocks at Max output 5. Display: Energy selected/ charging/ delivered/ disarmed 6. Controls: a. Power: On/Off b. Mode: (1) ECG Monitor (2) Defibrillator energy selector c. ECG size selection (x0.5, x1, x2) Ref: P:\Projects Database\3. Closed Projects\Med & GS - 7V0545601 Generic Spec for SPAME\Rep-6485 - 2009-0522.doc 52 © Crown Copyright Cobham Technical Services ERA Technology Report 2009-0522 d. ECG lead selection e. QRS beep volume f. ECG display freeze g. Heart rate alarm On/Off h. Recorder mode i. Synchronised shock delivery j. Paddles - charge/discharge/ energy select k. Auto, semi-auto, manual 7. Audio: Charging, charged, voice prompts with automated modes 8. Miscellaneous: a. Hands free and paddles (adult, paediatric, internal) available. b. Pace functionality independent. c. Monitor through pads. 9. Power supply: See Appendix C17 APPENDIX C6: PACEMAKER – EXTERNAL (Transthoracic) 1. Rate: 30 - 180 stimulations/min 2. Output current: 30 – 180 mA 3. Display: a. Waveform b. Rate c. Output d. Mode/ disabled/enabled e. Battery condition f. 4. Fault indication Controls: a. Power: On/Off Ref: P:\Projects Database\3. Closed Projects\Med & GS - 7V0545601 Generic Spec for SPAME\Rep-6485 - 2009-0522.doc 53 © Crown Copyright Cobham Technical Services ERA Technology Report 2009-0522 b. Mode: Demand, asynchronous c. ECG size selection (x0.5, x1, x2) d. ECG lead selection e. QRS beep volume f. ECG display freeze g. Heart rate alarm (20-300BPM) h. Output current i. Rate j. Recorder mode k. Alarm Silence/Reset 5. Alarms a. Pacer fault at self test b. Lead fault c. Heart rate 6. Audio: a. QRS/ pacing b. Alarm 7. Power supply: See Appendix C17 APPENDIX C7: ECG 1. 3 lead, 5 lead, 12 lead ECG 2. Input: a. 3, 5,12-lead patient cable b. Via Defibrillator paddles c. Manual and hands free defibrillation 3. Display: a. Minimum 80 x 100 mm Ref: P:\Projects Database\3. Closed Projects\Med & GS - 7V0545601 Generic Spec for SPAME\Rep-6485 - 2009-0522.doc 54 © Crown Copyright Cobham Technical Services ERA Technology Report 2009-0522 b. Non-fade c. Sweep speed 25 mm/sec d. View time 4 secs e. Freeze function f. Visual display of heart rate. Interchangeable with source when available g. Dual wave form; one with lag. h. ST segment analysis 4. Controls: a. Power: On/Off b. Mode: (1) ECG Monitor (2) Multiple waveform c. ECG size selection (x0.5, x1, x2) d. ECG lead selection e. QRS beep volume f. ECG display freeze g. Heart rate alarm on/off/ variable h. Recorder settings i. 5. Alarm Silence/Reset Alarms: a. High/Low with default and variable settings b. Lead fault/disconnect 6. Chart recorder: a. Width 50 mm b. Display 4 secs c. Manual and automatic mode (with alarm indication) d. Speed 25 mm/sec Ref: P:\Projects Database\3. Closed Projects\Med & GS - 7V0545601 Generic Spec for SPAME\Rep-6485 - 2009-0522.doc 55 © Crown Copyright Cobham Technical Services ERA Technology Report 2009-0522 e. Trending of measured parameters when part of multifunction monitor 7. Tachometer: a. Range: 20-300 bpm b. Constant averaging time: 5 secs c. Monitor response times according to prevailing guidelines eg. AAMI EC-13-1992 d. Alarms: high/low user selectable with default settings available 8. Power supply: See Appendix C17 APPENDIX C8: END-TIDAL CARBON DIOXIDE MONITOR 1. Infra-red absorption method (mainstream) rather than gas sampling (sidestream) preferred. Should include breath by breath monitoring and be suitable for all patients from neonatal to adult. 2. Range: a. Pressure: 0-80 mm Hg, 0-20 kPa – Accuracy End-tidal CO2: ± 4 mm Hg, ± 0.15 kPa b. Rate: 0-55 rpm 3. Display: a. Waveform b. Selectable units: %, kPa, mm Hg c. Alarm settings d. Rate 4. Controls: a. On/Off b. Alarm On/Off c. Alarm Silence/Reset 5. Alarms: a. Upper and lower limits in 1mm Hg increments Ref: P:\Projects Database\3. Closed Projects\Med & GS - 7V0545601 Generic Spec for SPAME\Rep-6485 - 2009-0522.doc 56 © Crown Copyright Cobham Technical Services ERA Technology Report 2009-0522 b. Audio and visual warning c. Respiratory rate upper and lower 6. Trends: all parameters trended over 12 hours recorded every 15 mins 7. Resolution: 1 mm Hg, 0.1 kPa 8. Power: See Appendix C17 APPENDIX C9: INVASIVE PRESSURE MONITOR 1. Invasive Method 2. Minimum 2, but ideally 4 Channels to measure any combination of: a. Arterial Pressure b. Central Venous Pressure c. Pulmonary Artery Pressure d. Pulmonary Artery occlusion Pressure e. Intra-cranial pressure (see Appendix C13) 3. Range a. Pressure: -10 mm Hg to + 300 mm Hg – Accuracy ± 2 mm Hg b. Rate: 20-300 bpm 4. Display: a. Waveforms b. Systolic pressure c. Diastolic pressure d. Mean pressure e. Rate (where applicable) 5. Controls: a. On/Off b. Re-label, Re-scale, Re-zero Ref: P:\Projects Database\3. Closed Projects\Med & GS - 7V0545601 Generic Spec for SPAME\Rep-6485 - 2009-0522.doc 57 © Crown Copyright Cobham Technical Services ERA Technology Report 2009-0522 c. Alarm On/Off d. Alarm Silence/Reset 6. Alarms: a. All parameters - upper and lower limits in 5 mm Hg increments b. Audio and visual warning 7. Trends: all parameters trended over 12 hours 8. Attached Transducer (disposable item), response: 5 9. Zero Adjustment: ± 1 mm Hg 10. Resolution: 1 mm Hg 11. Power: See Appendix C17 V/V/mmHg APPENDIX C10: NON-INVASIVE BLOOD PRESSURE MONITOR 1. Multiple Cuff sizes suitable for Neonatal, Paediatric and Adult 2. Range: a. Pressure: 30-240 mm Hg systolic, 10-200 mm Hg diastolic – Accuracy +5 mmHg mean error, + 8mmHg standard deviation b. Rate: 30-200 bpm 3. Resolution: a. Pressure: 1 mm Hg b. Rate: 1 bpm 4. Display: a. Systolic pressure b. Diastolic pressure c. Mean arterial pressure d. Display in mmHg/kPa e. Pulse rate Ref: P:\Projects Database\3. Closed Projects\Med & GS - 7V0545601 Generic Spec for SPAME\Rep-6485 - 2009-0522.doc 58 © Crown Copyright Cobham Technical Services ERA Technology Report 2009-0522 5. Controls: a. Start/Stop b. Alarm On/Off c. Alarm Silence/Reset 6. Alarms: a. Artifact b. Check cuff c. Tighten cuff d. Cuff leak e. Motion f. 7. Pre-set and variable high / low limits adjustable for all 4 parameters in increments of 5 mm Hg. Modes: a. Manual b. Automatic - variable 0-30 minute intervals c. Stat/ venous stasis 8. Power: See Appendix C17 APPENDIX C11: OXIMETER 1. Arterial oxygen saturation monitor - various probes for measurements from extremities, nasal or earlobe with suitability for neonatal, paediatric and adult. 2. Pulse Rate: a. Range: 30-250 bpm b. Accuracy: ± 5% or 5bpm whichever is less c. Resolution: 1 bpm d. Pulse beep - adjustable volume Ref: P:\Projects Database\3. Closed Projects\Med & GS - 7V0545601 Generic Spec for SPAME\Rep-6485 - 2009-0522.doc 59 © Crown Copyright Cobham Technical Services ERA Technology Report 2009-0522 3. Saturation a. Range: 35-99% b. Accuracy (85-99%) ± 2% c. Resolution: 1% d. Update period: Every pulse after 4 valid pulses. 4. Display using LCD: a. Saturation b. Pulse rate c. Plethysmographic pulse wave form 5. Controls: a. On/Off b. Alarm On/Off c. Alarm Silence/Reset 6. Alarms: a. Audio/visual b. Low saturation – adjustable c. High/Low rate – adjustable d. Check probe e. Searching f. Signal OK g. No signal h. Low perfusion 6. i. Alarms Enabled/Disabled (icon) j. Testing Power supply: See Appendix C17 Ref: P:\Projects Database\3. Closed Projects\Med & GS - 7V0545601 Generic Spec for SPAME\Rep-6485 - 2009-0522.doc 60 © Crown Copyright Cobham Technical Services ERA Technology Report 2009-0522 APPENDIX C12: TEMPERATURE MONITOR 1. Range: 25 – 50 C 2. Accuracy: ± 0.2 C 3. Response time: 90% of change in less than 30 seconds 4. Probe: Disposable Probe/Covers to read (as a minimum) a. Skin Temperature b. Oesophageal Temperature c. Rectal Temperature d. Tympanic Temperature e. Bladder Temperature Compatibility with a variety of probes will be required to access the variable nature of the above. 5. Display resolution: Digital Readout to 0.1 decimal @ 0.1 steps 6. Controls: a. Alarm On/Off b. Alarm Silence/Reset 7. Alarms: Integrated Audio/Visual Alarm 8. Power Supply: See Appendix C17 APPENDIX C13 : INTRA-CRANIAL PRESSURE MONITOR 1. Range: -50 to +250 mmHg (zero range ± 100 mmHg) 2. Drift ±3 mmHg per 24 hrs maximum 3. Accuracy ±1% or ±1 mmHg 4. Temperature sensitivity ≤0.15 mmHg/°C over the range of 25 to 45°C Ref: P:\Projects Database\3. Closed Projects\Med & GS - 7V0545601 Generic Spec for SPAME\Rep-6485 - 2009-0522.doc 61 © Crown Copyright Cobham Technical Services ERA Technology Report 2009-0522 5. Display a. Systolic/diastolic/mean pressure b. Trends over 8 hours c. Waveform d. Power source e. Low battery f. Charging g. Alarm 6. Controls a. On/off b. Zero c. Range d. Calibrate e. Freeze f. Trend g. Alarm On/Off h. Alarm Silence/Reset 7. Alarm a. Increments of 1 mmHg mean ICP b. Low range -50 to 200 mmHg c. High range -50 to 200 mmHg d. Default settings e.g. 0-20mmHg 8. Audio: a. Alarm: Systolic / diastolic/ mean, low battery 9. Power: See Appendix C17 Ref: P:\Projects Database\3. Closed Projects\Med & GS - 7V0545601 Generic Spec for SPAME\Rep-6485 - 2009-0522.doc 62 © Crown Copyright Cobham Technical Services ERA Technology Report 2009-0522 APPENDIX C14: PACEMAKER – INVASIVE 1. Pulse width: 1.8 msec 2. Pulse amplitude: 0-20 mA variable 3. Mode: Single chamber. Ventricular, VVI, atrial. AAI 4. Rate: variable: 30-800 stimulations/min, ventricular 30-180, atrial 80-800 5. Display: a. Pacing b. Sensing c. Battery condition 6. Controls: a. Power: On/Off b. Output current c. Rate d. Sensitivity e. Mode specific controls 7. Alarms: a. Fault indication: device failed self test b. Battery low (warning time of up to 24 hours) c. Battery failure 8. Power supply: battery life minimum 240 hours, continues function during battery change APPENDIX C15: PERIPHERAL NERVE STIMULATOR 1. Stimulation via skin electrodes, internal electrodes 2. Automatic Repeat Modes: a. 0-80mA or 1 second twitch Ref: P:\Projects Database\3. Closed Projects\Med & GS - 7V0545601 Generic Spec for SPAME\Rep-6485 - 2009-0522.doc 63 © Crown Copyright Cobham Technical Services ERA Technology Report 2009-0522 b. Train-of-Four stimulations - pulse interval = 0.5 seconds (± 5%) c. 50 Hz Tetanic stimulus: pulse interval = up to 5 seconds (± 5%), with lockout (5min) 3. Display a. Digital display of peak current in mA delivered to the patient b. Stimulus in progress c. Internal /external mode d. Lead disconnection/ failure f. 4. Battery condition Controls: a. On/Off b. Mode c. Current d. Programme e. Alarm Silence/Reset 5. Alarms: a. Fault 6. Audio: a. Stimulus in progress 7. Output Stimulus Pulse: a. Width: 200 milliseconds (± 5%) b. Amplitude: Adjustable 0-10 mA internal, 0-150 mA external 8. Accuracy: 1 mA ± 1% 9. Power: Battery, minimum 200 hrs use. Ref: P:\Projects Database\3. Closed Projects\Med & GS - 7V0545601 Generic Spec for SPAME\Rep-6485 - 2009-0522.doc 64 © Crown Copyright Cobham Technical Services ERA Technology Report 2009-0522 APPENDIX C16: PATIENT FORCED AIR WARMING SYSTEM 1. Heating/cooling/maintenance of normothermia 2. Use with various blanket configurations e.g. total body, upper body etc 3. Potential for fluid warming system to be incorporated 4. Variable temperature settings, range 20°C to 40°C set at top and bottom end. 5. Temperature setting change may be seamless or stepped into ranges 6. Cut-out of heater in event of overheat at preset of no higher than 54°C ±2°C 7. Air filtration system 8. Duration of up to 24 hours at maximum duty cycle, minimum acceptable duration 4 hours. 9. Display: a. Power supply b. Temperature or temperature range selected c. Overheat indication 11. Controls: a. On/off b. Temperature/temperature range select c. Alarm Silence/Reset 10. Alarms: a. Audible and visual overheat alarm with simultaneous cut-out of heater element 12. Power: See Appendix C17 13. Miscellaneous: With present technology power consumption remains too high for most aircraft types to supply. In the interim less capable systems may be considered providing they conform to general standards of EMC and mechanical compatibility as described in Annex C17 Ref: P:\Projects Database\3. Closed Projects\Med & GS - 7V0545601 Generic Spec for SPAME\Rep-6485 - 2009-0522.doc 65 © Crown Copyright Cobham Technical Services ERA Technology Report 2009-0522 APPENDIX C17 GENERIC COSIDERATIONS FOR ALL TYPES OF EQUIPMENT 1. Environment: All environments the equipment may encounter when stored, transported or used must be considered. Extremes of temperature and humidity may be experienced along with associated hazards of sand/dust and water ingress. Suitable IP ratings for the equipment need to be in place, but in some instances user precautions and suitable packaging may be required in addition. 2. The equipment may be subjected to EMC emissions onboard aircraft, in proximity to land based equipment and on board ships. The equipment must be able to withstand levels of insult not normally experienced by medical equipment and should be robust enough to maintain function and integrity in the military environment. Equipment needs to withstand the effects of normal aircraft operation and emergencies. It should be tested against the appropriate standards for parameters such as: vibration, acceleration, deceleration, rapid decompression, drop, topple, blackout conditions, bright conditions etc, to ensure patient and aircraft safety. 3. Transport Modes: Equipment will be used in the air on a wide range of military airframes, both rotary and fixed wing. Commercially Owned Military operated Aircraft [COMA] may also be employed. The equipment must continue to operate during road and sea transport to and from the airhead or hospital facilities. 4. Engineering Support: Equipment should be within the capability of appropriately trained MDSS technicians to maintain at first and second line to the support levels as derived from the associated Integrated Logistic Support (ILS) Logistic Support Analysis (LSA) Task output, Test equipment requirements are to be kept to minimum levels and ideally met by the generic test equipment held by the authority,. Generic specified equipment acquisition should be a Triservice initiative and be subject to programme management prioritisation. Prior to final procurement ease of maintenance assessments must be undertaken as part of the Integrated Test Evaluation & and Acceptance (ITEA) process in particular the Logistic Demonstration, (LD). During clinical use intervention by MDSS should be confined to, electrical safety, equipment function monitoring, fault interpretation, straightforward troubleshooting and identification of hazards. There should be no requirement for specialised test equipment during transfers. During deployment it is acknowledged that some test equipment may be required for quality control or routine maintenance. Ref: P:\Projects Database\3. Closed Projects\Med & GS - 7V0545601 Generic Spec for SPAME\Rep-6485 - 2009-0522.doc 66 © Crown Copyright Cobham Technical Services ERA Technology Report 2009-0522 5. The level of MDSS support must be to the level that can sustain the equipment during routine maintenance cycles, while it is being stored prior to use. This will be further influenced by the amount of equipment, the prevailing readiness states and the level of operational activity. 6. Training Requirements: Both users and engineers should receive effective training prior to the equipment being brought into service. This includes technical and clinical aspects of use. These requirements should be identified by effective ILS training needs analysis (TNA). Manufacturer training courses are required initially for certain technical training. Bespoke Defence Systems Approach to Training (DSAT) compatable training should be provided to all personnel. This is to consolidate technical and clinical training to prepare for the military transfer environment. The training executive should be the Training Development Authority (TDA). They should co-ordinate Via the Training Steering Group for the production of the TNA with the subject matter experts. Continuation training is essential for those personnel not employed in the use or maintenance of the equipment on a regular basis to help off set skill fade. 7. Power Requirements: Equipment should normally be capable of being powered from a variety of sources. These include internal or external batteries. Other sources available will be 12 -13.5V dc vehicle supply, 28-31V dc aircraft supply and 110-240V 50 Hz ac aircraft supply. The ac 240V may be supplied directly from the aircraft or via step down systems connected to the aircraft 400 Hz supplies. The flexibility of multiple power supplies for life vital equipment such as ventilators produces a more robust capability and reduces the logistic requirements for missions. It also reduces risk to the patient and increases maintainability of the equipment. For small portable devices alternate power supplies may be impractical or unnecessary. Where internal batteries are the only source of power they should, under normal circumstances be, hot swappable, particularly for life vital equipment. Functionality of the equipment must be maintained during battery changeover whenever possible. 8. Displays: Displays should preferably be in colour and have brightness and contrast control. They will be required to be visible in bright sunlight and also adjustable to take account of blackout conditions. The angle of view should such to allow good visibility for the users. Displays should be invertable and configurable for example with waveform size. The display should also include SI Units. Ruggedised displays or other protection should be available, such as protective covers/ carry cases. 9. Alarms: The environment requires audible alarms to be sufficiently loud to attract attention (at least 80 db, higher in some situations) or audio signals must be capable Ref: P:\Projects Database\3. Closed Projects\Med & GS - 7V0545601 Generic Spec for SPAME\Rep-6485 - 2009-0522.doc 67 © Crown Copyright Cobham Technical Services ERA Technology Report 2009-0522 of being relayed remotely to crew headsets. Visual alarms should use colour change or state change [steady to flashing]. Adjustable limits along with auto set and auto adjust are beneficial and the alarm should default to ON, but be programmable. Data collection and storage with a file format to enable email transmission is desirable. Advance into blue tooth connectivity and should be considered. 10. Functionality: Ease of use and maintenance is a fundamental consideration. This assists in training and skill maintenance (but is not a substitute for these considerations). Ergonomic and intuitive design also contributes to reduced risk to operators/ technicians and markedly increases patient safety. Ref: P:\Projects Database\3. Closed Projects\Med & GS - 7V0545601 Generic Spec for SPAME\Rep-6485 - 2009-0522.doc 68 © Crown Copyright