Delivered by Publishing Technology to: Wright State University IP: 130.108.121.217 On: Wed, 16 Apr 2014 19:58:19 Copyright: Aerospace Medical Association Aviation, Space, and Environmental Medicine x Vol. 85, No. 4 x April 2014 473 TECHNICAL NOTE C ICEK I, S ERRES JL. Safe-to-fly test and evaluation of fatigue re- search study test devices. Aviat Space Environ Med 2014; 85:473–9. Introduction: The U.S. Air Force (USAF) School of Aerospace Medi- cine is conducting a fatigue research study titled “ Assessment of Fatigue in Deployed Critical Care Air Transport Team (CCATT) Crews” using two electronic devices onboard USAF aircraft during actual CCATT missions. Both devices were subjected to testing to support a safe-to-fly (STF) rec- ommendation prior to their use in flight. The purpose of the test and evaluation process was to ensure the devices can be safely operated in flight without posing a hazard to the research participant, crewmembers, or aircraft during an actual mission. The goal of this article is to outline the key factors involved in the STF certification process. Methods: This paper discusses the test and evaluation process for making STF recom- mendation and presents the rationale for selecting the applicable tests and test susceptibilities. The following STF tests were conducted: base- line assessment, vibration, electromagnetic interference, altitude, rapid decompression, and explosive atmosphere. Acceleration testing, envi- ronmental (temperature and humidity) testing, and in-flight assessments were deemed not required for the STF certification of these devices. Results: Based on the results of this study, the devices were deemed safe to the flight crew and aircraft. Conclusions: The outcome of this study was subsequent approval letters issued by the respective airframe system program offices to allow use of these devices onboard USAF C-130 E/H/J, C-17, and KC-135 aircraft. Keywords: aeromedical flight testing, aviation fatigue, CCATT. T HE DEPARTMENT of Aeromedical Research at the U.S. Air Force (USAF) School of Aerospace Medicine, Wright-Patterson Air Force Base (WPAFB), is conducting a fatigue assessment study on Critical Care Air Transport Team (CCATT) personnel titled “Assessment of Fatigue in Deployed CCATT Crews.” This study includes an in- theater activity monitoring phase to identify sleep pat- terns and collect subjective and objective fatigue data on the participants. In support of this project, the Surgeon General’s office at Air Mobility Command tasked the USAF Agile Combat Support Directorate, Aeromedical Branch, Aeromedical Test Lab (ATL) for safe-to-fly (STF) testing of a PDA and actigraph to ensure compatibility with aircraft and mission requirements. These types of devices are commonly used for ground-based fatigue field studies (3,14). Similar meth- ods have been proposed and used in fatigue studies in commercial aviation when commercial flight atten- dants were studied (13,16,18). A search of the literature did not reveal any other research study in military avi- ation to use these devices. Therefore, the devices must undergo testing to ensure that they do not adversely affect the operation of aircraft systems and that the air- craft systems do not adversely affect the proper opera- tion of the devices. In general, medical devices are designed to function in environmentally controlled locations, such as station- ary hospitals, and not in the harsh, dynamic aircraft en- vironment. Yet, the same medical devices used to care for patients in a hospital environment are often the most capable devices for patient care during transport from one location to another. Often referred to as medical evacuation (medevac) and aeromedical evacuation (AE) missions, these missions supply the means to provide en route medical care to a wide variety of patients. How- ever, since medical devices are often designed for station- ary, controlled facilities, there is the chance the devices may adversely affect aircraft operations and, conversely, the aircraft may adversely affect the operation of the medical equipment (12). Additionally, all medical equip- ment, including research devices, identified for use on USAF fixed-wing aircraft must undergo STF evaluation in accordance with Section 2.5.1.7 of Air Force Instruction (AFI) 11-2AEV3, General Flight Rules (20), before the STF certification can be issued by the authorizing aircraft system program offices. Military and civilian standards, regulations, and specifications, as well as professional experience and expertise, are all part of the STF test and evaluation process. The aeromedical equipment STF test process starts with receiving a formal letter from the requesting agency: Air Mobility Command. Fig. 1 describes the STF test process in an activity flow diagram. The activities of the ATL are shown in the second column. If the manufacturer of a test article does not have Food and Drug Adminis- tration (FDA) clearance at the time of testing, testing may commence; however, an STF recommendation letter is sought until the manufacturer shows evidence of FDA clearance (12). Medical equipment that is under testing and evaluation is expected to have an identification From the Agile Combat Support Directorate, Aeromedical Test Lab, U.S. Air Force, and the U.S. Air Force School of Aerospace Medicine, Wright-Patterson Air Force Base, OH. This manuscript was received for review in April 2013. It was accepted for publication in October 2013. Address correspondence and reprint requests to: Jennifer Serres, Ph.D., Department of Aeromedical Research, USAF School of Aero- space Medicine, Bldg. 840, W 118.14, 2510 Fifth St., Wright-Patterson AFB, OH 45433-7913; jennifer.serres@wpafb.af.mil. Reprint & Copyright © by the Aerospace Medical Association, Alexandria, VA. DOI: 10.3357/ASEM.3729.2014 Safe-to-Fly Test and Evaluation of Fatigue Research Study Test Devices Ismail Cicek and Jennifer L. Serres