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USAFSAM-TR AD-A TESTING AND EVALUATION OF THE INTERNATIONAL BIOMEDICAL INC. NEONATAL TRANSPORT SYSTEM Thomas E. Philbeck, Jr., Master Sergeant, USAF Howard S. Heiman, Major, USA, MC Ernest G. Roy, Master Sergeant, USAF DTIC EE L EC!-E AUG i December 1990 Final Report For Period April April I'~ll ll ll II II I Approved far public release; distribution is unlimited. I USAF SCHOOL OF AEROSPACE MEDICINE Human Systems Division (AFSC) Brooks Air Force Base, TX NOTICES This final technical report was submitted by personnel of the Crew Systems Branch, Crew Technology Division, USAF School of Aerospace Medicine, Human Systems Division, AFSC, Brooks Air Force Base, Texas, under job order This report was prepared as an account of work sponsored by an agency of the United States Government. Neither the United States Government nor any agency thereof, nor any of their employees, nor any of their contractors, subcontractors, or their employees, makes any warranty, expressed or implied, or assumes any legal liability or responsibility for the accuracy, completeness, or usefulness of any information, apparatus, product, or process disclosed, or represents that its use would not infringe privately owned rights. Reference herein to any specific commercial product, process, or service by trade name, trademark, manufacturer, or otherwise, does not necessarily constitute or imply its endorsement, recommendation, or favoring by the United States Government or any agency, contractor, or subcontractor thereof. The views and )pinion-3 of the author expressed heran dv- not nececzarily state or reflect those of the United States Government or any agency, contractor, or subcontractor thereof. When Government drawings, specifications, or other data are used for any purpose other than in connection with a definitely Government-related procurement, the United States Government incurs no responsibility or any obligation whatsoever. The fact that the Government may have formulated or in any way supplied the said drawings, specifications, or other data, is not to be regarded by implication, or otherwise in any manner construed, as licensing the holder or any other person or corporation; or as conveying any rights or permission to manufacture, use, or sell any patented invention that may in any way be related thereto. The voluntary, fully informed consent of the subjects used in this research was obtained as required by AFR The Office of Public Affairs has reviewed this report, and it is releasable to the National Technical Information Service, where it will be available to the general pub;c, including foreign nationals. This report has been reviewed and is approved for publication. RICHARD J. KNECHT, Lt Col, USAF, NC Project Scientist ROGER L. STORK, Colonel, USAF, BSC Supervisor EOGESWColonel, USAF, MC, CFS Commander REPORT DOCUMENTATION PAGE Form Approved I 0MB No Public reporting burden for this collection of information is estimated to average I hour per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information Send comments re~arding this burden estimate or any other aspect of thi$ collection of information, including suggestions for reducing this burden. to Washington Headquarters Services. Directorate or information Operations ard Reports, 1215 Jetfeon Davis Highway, Suite Arlington, VA and to the Office of Management and Budget. Paperwork Reduction Project ( ). Washington, D( AGENCY USE ONLY (Leave blank) 2. REPORT DATE 3. REPORT TYPE AND DATES COVERED I December 1990 Final - Apr 1989 to Apr TITLE AND SUBTITLE 5. FUNDING NUMBERS Testing and Evaluation of the International Biomedical PE F Inc. Neonatal Transport System PR AUTHOR(S) TA - 16 WU - 12 Thomas E. Philbeck,Jr.; Howard S. Heiman; Ernest G. Roy 7. PERFORMING ORGANIZATION NAME(S) AND ADDRESS(ES) 8. PERFORMING ORGANIZATION USAF School of Aerospace Medicine/VNL Human Systems Division (AFSC) Brooks Air Force BaseTX REPORT NUMBER USAFSAM-TR SPONSORING/ MONITORING AGENCY NAME(S) AND ADDRESS(ES) 10. SPONSORING / MONITORING AGENCY REPORT NUMBER 11. SUPPLEMENTARY NOTES 12a. DISTRIBUTION /AVA!LABILITY STATEMENT 12b. DISTR!BUTION CODE Approved for public release; distribution is unlimited. 13. ABSTRACT (Maximum 200 words) The Military Airlift Command (MAC) is the central manager for aeromedical evacuation. Infants must be transported in a safe, controlled environment. The International Biomedical Inc. Neonatal Transport System (NTS) has beern purchased by several Department of Defense medical treatment facilities for transporting the infants. The Aeromedical Research Function tested and evaluated the NTS, finding that 3 components must be modified to pass the electromagnetic interference standards. The incubator must be modified to allow for carbon dioxide venting and to keep the hood assembly intact during removal. The suction device must not be used outside the NTS structure. The NTS must be operated by a trained neonatal staff member. Wooden blocks and 4 cargo tie-down straps must be used to secure the NTS. The ventilator gas cylinders must not protrude. If the requirements are niet, the International Biomedical Inc. NTS is a safe and reliable device for the airborne transport of neonatal infants. 14. SUBJECT TERMS 15. NUMBER OF PAGES 38 Aeromedical Evacuation; Neonatal Transport System; International 16. PRICE CODE Biomedical Inc. 17. SECURITY CLASSIFICATn'x ' 4 Yrv ':LA' '!IFC.AIION 19. SECURITY CLASSIFICATION 20. LIMITATION OF ABSTRACT OF REPORT OF THIS PAGE OF ABSTRACT UNCLASSIFIED UNCLASSIFIED UNCLASSIFIED UL NSN Standard Form 298 (Rev 2-89) P, ii'r tiwo by A Ni ti d I 18i 24102 TABLE OF CONTENTS BACKGROUND... 1 DESCRIPTION METHODS... 3 Initial Inspection... 3 Test Setups and Performance Checks... 4 Electromagnetic Interference... 7 Altitude... 8 Airborne Feasibility... 9 RESULTS Initial Inspection Electromagnetic Interference Altitude Airborne Feasibility CONCLUSIONS ACKNOWLEDGMENTS REFERENCES APPENDIX A: Neonatal Transport System C-21 Mounting Instructions...23 APPENDIX B: Design and Specifications of the Neonatal Transport System Wooden Support Blocks Fig. List flfgures 1. The International Biomedical Neonatal Transport System Diagram of the C-21 interior Securing the NTS on the C-9A aircraft Securing the NTS on the C-1 41 B aircraft Securing the NTS on the C-21 aircraft Table ULofale 1. Initial MVP Ventilator Settings during Performance Checks... )nfor 2. Battery Operation Times Per ,!nt Change of Ventilator Measurements, at 10,000 ft Altitude v. Ar Ground Level ;0 Icopy '\NSrcrn 1 D13 tribution, Aal Aailbility Codes Dist Special TESTING AND EVALUATION OF THE INTERNATIONAL BIOMEDICAL INC. NEONATAL TRANSPORT SYSTEM BACKGROUND The Department of Defense (DOD) provides care at medical treatment facilities classified by 4 levels; Level I facilities having the least capabilities, and Level IV having the most (1). Newborns delivered at smaller DOD medical facilities often need rapid access to Level IV care. The larger DOD medical centers in each region are tasked with supporting the smaller medical treatment facilities, which are equipped and staffed with only Level I or II nurseries. When feasible, the Military Airlift Command (MAC) has provided the aeromedical support needed to transport infants from the smaller facilities to the larger facilities using equipment found acceptable by the USAF School of Aerospace Medicine (USAFSAM) at Brooks AFB, TX. In addition, Air Force, Army, Navy, and Coast Guard helicopter units have provided neonatal transport on a case-by-case basis, using a mixture of approved, unapproved, or untested medical equipment. To use the unapproved and untested equipment, a waiver is required by the 375th Aeromedical Airlift Wing surgeon (375 AAW/SG); a process that can consume precious time. (NOTE: The 375 AAW was later redesignated the 375th Military Airlift Wing, and the SG components were integrated with HQ MAC/SG.) The life and death nature of most newborn referrals to Level IV facilities requires a quick response time. The standard of care for civilian regional centers involves use of trained neonatal transport teams who leave the Level IV facility, taking along all equipment and supplies needed for the transfer. These teams stabilize and transport the infant from the Level I or II facility to the Level IV facility, using the same equipment and a hospital-to-hospital concept. This concept allows the fastest delivery to Level IV care. There is no transfer of the baby to different incubators, monitors, pumps, or ventilators. Currently, MAC uses an airfield-to-airfield concept; and insists that only approved or waivered equipment be used aboard the aircraft (2). This concept often results in 2 equipment changes; when the infant arrives at the aircraft from the Level I or II facility, and when the baby leaves the aircraft to proceed to the Level IV facility. The American Academy of Pediatrics guidelines call for continuous critical care between aircraft and ambulances (3). Changing equipment causes unnecessary risks to critically ill newborns. A neonatal transport system (NTS), the Airborne Infant Life Support System, manufactured by International Biomedical Inc. of Houston TX, was purchased by 3 DOD Level IV medical facilities in The NTS was acquired to avoid the problems associated with in-transit equipment changes for use primarily on the C-21 Learjet; with the C-9A and C-141B as secondary aircraft. Untested by USAFSAM, the NTS was used in this manner for several months, with the 375.AAW surgeon granting a waiver on each occasion. Eventually some flight safety issues were raised by pilots anti operations persnr,,j; primarily fccusng on secuiing the NTS within the airframes, and the question of electromagnetic interference (EMI) from the medical equipment contained within the system affecting 1 aircraft navigation and communications. Early in 1989, the 375 AAW surgeon suspended granting waivers for the NTS, and directed that, if the system was to be further used on MAC aircraft, it must first be tested and evaluated by USAFSAM. DESCRIPTION The NTS measures 96.5 cm (38 in.) length; 48.3 cm (19 in.) width; and cm (44 in.) height. The system weighs about 90.9 kg (200 Ib). The base is made of tubular steel and sits on 10.2 cm (4 in.) rubber wheels (Fig.1). While individual components may be removed or added, depending on the preference of the neonatal staff, the following components were tested and evaluated at USAFSAM: -- Incubator, Airborne Life Support System (ALSS), Model 20H Ventilator, Bio-Med Devices, Model MVP Neonatal Monitor, Corometrics, Model Pulse Oximeter, Novametrix, Model Neonatal Blood Pressure Monitor, CAS Medical Systems Model Air-Oxygen Blender, Bird, Model 3800A. -- Suction Unit, Laerdal, Model LSU Oxygen Monitor, Catalyst Research, Model MiniOX II Infusion Pump, Travenol, Model AS20S. -- Pulse Oximeter, Nellcor, Model N Gas Cylinder, Pressed Steel Tank Co, Model 3HT Extensive testing of ALSS Model 185 Infant Transport Incubator was conducted in The Model 185 is very similar to the Model 20H, which allowed minimal testing of the 20H. For further details, refer to USAFSAM-TR-89-35, Evaluation of the Model 185 Airborne Life Support Systems Infant Transport Incubator, dated March This item was previously tested for general aeromedical evacuation use in May At that time it was considered unacceptable due to the constant monitoring and adjustments required during altitude changes. 3 This item was previously tested for general aeromedical evacuation use in May At that time it was considered unacceptable due to excessive EMI emissions. 4 Fxtensive testing of the MiniOX III was conducted in , which allowed minimal testing for use with the NTS. For further details, refer to USAFSAM-TR-90-25, Testing and Evaluation of the Catalyst Research MiniOX III Oxygen Monitor. 2 Figure 1. The international Biomedical Neonatal Transport System. METHODS Test methods and performance criteria used were derived from MIL-STD 461C (4), Emergency Care Research Institute (ECRI) Health Devices standards (5), and the Aeromedical Research Function Procedures Guide (6), covering safety and human factor issues regarding the equipment to be tested. A performance check was developed verifying proper functioning of the equipment under various test conditions. The following 3 tests generally involved repetition of the performance check under specified conditions: -- Electromagnetic Interference -- Altitude (encompassing hypobaric and decompression testing) -- Airborne Feasibility Initial Inspection Each item was inspected externally and internally for faulty manufacture and possible damage incurred during shipment. Each item, except the Travenol Infusion 3 Pump and the Bird Blender, was disassembled and inspected for workmanship and component leakage or damage. The Travenol and the Bird devices could not be disassembled without damage. The items were checked to ensure they met safety requirements and operating characteristics, established in AFM 67-1, Vol V, Ch 21, Medical Equiplent Maintenance and Repair, and AFR 160-3, Electrical Safety in Medical Treatment Facilities. Ground resistance and leakage current measurements were made on each applicable electrical device. Operation and calibration procedures were verified with manufacturer specifications, and the performance check procedures described in the protocol developed by the Aeromedical Research Function staff. The following test equipment was used: Bio-Tek Instruments, Inc. DPM III P;essure Meter; DB&M Products Infant Test Lung; Grant Squirrel Meter/Logger, Model 1201; Mercury/Water Manometer; Bio-Tek Instruments, Inc. Lionheart Physiological Simulatcr; Perkin-Elmer Medical Gas Analyzer Model 1100; and Electrical Safety Analyzer, Model 431 F Mod-i. Test Setups and Performance Checks Test setups and performance checks were established to evaluate each function featured on the components of the NTS. Test setups and performance checks were as follows: ALSS incubator. The function of the incubator is to provide the infant with a warm environment, fresh air exchange (to prevent CO 2 buildup), and delivery of supplemental oxygen from an external source. Four temperature sensors (Grant Model EU-UU-V5) measured the incubator's temperature characteristics within the infant chamber. One sensor was placed outside the incubator to measure ambient air temperature for comparison. The temperatures were measured and logged using a Grant Squirrel MeteriLogger, Model The incubator was then prewarmed to 37 C (98.6 OF) using 110 VAC/60 Hz power. Temperatures were logged on the meter/logger every minute. The temperatures were also visually read and manually logged on Data Collection Sheets (DCS) every 5 min. Oxygen concentrations, and the flow required to achieve them, were measured at 10% increments up to the maximum achievable, depending on the altitude. MVP Ventilator. This item, used to provide respiration for the infant, has 2 modes of operation: time-cycled operation, which can be volume or pressure limited with or without positive end expiratory pressure (PEEP); or non-cycled operation, with or without continuous positive airway pressure (CPAP) or continuous oxygen administration. The ventilator was connectpd to the DB&M Product Model infant test lung, using the patient breathing circuit. The test lung analog outputs were connected to the Gould Model 2800S strip-chart recorder for lung and airway pressure measurements during the initial inspection and altitude testing. Flow rates, inspiratory and expiratory times, and tidal volumes were measured manually; as was patient initiated spontaneous breathing. High and low airway pressure safety valves were also checked. The ventilator was first checked in the time-cycled mode, with initial settings as listed in Table 1. 4 Table 1. INITIAL MVP VENTILATOR SETTINGS DURING PERFORMANCE CHECKS Setting lime Cycled Mode Non-Cycled Mode Mode Cycled CPAP Inspiratory Time Expiratory Time Airway Pressure 28 cm H20 28 cm H20 Flow 4 Ipm 4 1pm PEEP/CPAP Off Fully on FiO2 30% 30% Breath Rate With the ventilator operating at the settings, a 1 -min recording of the waveform was made. The PEEP was adjusted to 8, then to maximum, and back to 0. The maximum pressure control was set to 20, and returned to the maximum setting. Inspiratory time was changed to 0.5, and expiratory time to 1.0, which provided a breath rate of 40. This waveform was recorded for 1 min. The settings were returned to the original positions. The expiratory valve on the tubing was occluded, and the ventilator safety pressure valve activation point was recorded. The flow rate was measured by using a pneumotach at the expiratory valve outlet. Next the ventilator was checked in the non-cycled mode, with settings listed in Table 1. The CPAP was adjusted to mid and then maximum pressure points, noting the pressures obtained. Corometrics Monitor. Five physiological parameters are measured by the monitor: Invasive blood pressure, heart rate, ECG, respiration, and skin temperature. The monitor was connected directly to the Bio-Tek Lionheart Model MSP-I Multiparameter Simulator, using the Corometrics monitor cables. The Lionheart simulator was set to provide the following rates: -- Heart Rate: Respirations: Blood Pressure: 10 mmhg -- Temperature: 30 0C After I min, the monitor reading was manually recorded on a DCS. The simulator settings were then set at: -- Heart Rate: 120 and Respirations: 60 and Blood Pressure: 100 and 200 mmhg -- Temperature: 37 and 40 0C 5 Novametrix and Nellcor Pulse Oximeters. These devices measure 2 physiological parameters: calculated blood oxygen saturation (SaO2) and pulse rate. The sensor was attached to a finger of an Aeromedical Research staff member. Pulse readings were verified by palpating the radial pulse for 60 s. At the end of the 60 s, the pulse rate was taken from the pulse oximeter display and recorded, along with the actual palpated pulse. SaO2 readings were not verified. CAS Blood Pressure Monitor. This device measures 2 parameters: Blood pressure and pulse. A cuff was wrapped around an aluminum can, about 3.75 cm (1 1/2 in.) in diameter, simulating a patient's arm. The Bio-Tek pressure meter was placed inline with the pneumatic tubing connecting the cuff with the monitor. The monitor was manually cycled. While the monitor automatically released the air from the pneumatic circuit, the monitor display was watched. At the moment the monitor read the inline pressure as 100 mmhg, the pressure meter reading was noted; and again when the inline pressure was 50 mmhg. All readings from the monitor and the pressure meter were manually recorded for comparison..irdblender. This device blends compressed air and medical grade oxygen for delivery to a ventilator at 50 psi (±5); at percentages determined by the blender control knob; from 21 to 100%. There is also an auxiliary outlet for attaching a flow meter to supply oxygen to a manual resuscitator, and other low-flow applications. An oxygen flow meter was installed on the auxiliary outlet. Oxygen extension tubing was attached, to which the MiniOX Oxygen Monitor was attached, using the Tee-Adaptor. The blender was set to deliver 21 % oxygen. After 3 min, the MiniOX reading was taken and recorded on a DCS. The procedure was repeated, with the blender set at 50 and 100%. Laerdal Suction Unit. This device is for emergency oral-pharyngeal suctioning. The end of the suction tubing was adapted to connect directly to the Bio-Tek pressure meter. The suction, which has 2 settings (full and half), was set to half, and the pressure meter was observed. When the pressure was stabilized, the reading was recorded on a DCS. The procedure was repeated at the full setting. Travenol Infusion Pump. This auto-syringe device can deliver intravenous (IV), intra
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