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D-A234 593 


USAARL Report No. 91-14 



Test and Evaluation Report 
of the Physio Control Defibrillator/Monitor 
Model L1FEPAK®10 


us 


By 

Jeffrey D. Haun (Project Officer) 
and 

Joseph R. Licina (Project Officer) 
Bill Olding (UES, Inc.) 
Martin Quattlebaum (UES, Inc.) 


Biodynamics Research Division 


March 1991 


$ 


DT1C 

ELECTE 
APR 19 1991 

B 



y 


Approved for public release; distribution unlimited. 


91 4 17 088 

United States Army Aeromedical Research Laboratory 
Fort Rucker, Alabama 36362-5292 






Notice 


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Destroy this document when it is no longer needed. Do not return 
it to the originator. 

Disclaimer 

The views, opinions, and/or findings contained in this report are 
those of the author(s) and should not be construed as an official 
Department of the Army position, policy, or decision, unless so 
designated by other official documentation. Citation of trade 
names in this report does not constitute an official Department 
of the Army endorsement or approval of the use of such commercial 
items. 

Reviewed: 


f.cZjL 


DENNIS F. SHANAHAN 
LTC, MC, MFS 


Director, Biodynamics 


Research Division 


_ 

ROdER W. WILEY, O.D., Ph.D. 
Chairman, Scientific 
Review Committee 


Released for publication: 



DAVID H. KARNE 
Colonel, MC, S I 
Commanding 







UNCLASSIFIED 




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USAARL Report No. 91-14 



6*. NAME OF PERFORMING ORGANIZATION 
U.S. Army Aeromedical Research 
Laboratory 

6b. OFFICE SYMBOL 
(If applicable) 

SGRD-UAD-IE 

7*. NAME OF MONITORING ORGANIZATION 

U.S. Army Medical Research and Development 
Command 

6c. ADDRESS (City, State, and ZIP Code) 

P.0. Box 577 

Fort Rucker, AL 36362-5292 

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Fort Detrick 

Frederick, MD 21702-5012 

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WORK UNIT 
ACCESSION NO. 


11. TITLE (Include Security Classification) 

Test and Evaluation Report of the Physio Control Defibrillator/Monitor Model LIFEPAK® 10 


12. PERSONAL AUTHOR(S) 

Jeffrey D. Haun, Joseph R. Licina, Bill Olding, Martin Quattlebaum 


13b. TIME COVEREO 114. DATE OF REPORT (Year, Month. Day) IlS. PAGE COUNT 

™OM_TO_ | 1991 March 66 


16. SUPPLEMENTARY NOTATION 


COSATI COOES 


GROUP SUB-GROUP 



18, SUBJECT TERMS (Continue on reverse if necessary and identify by block number) 
Electromagnetic compatibility, test and evaluation, 
aeromedical equipment 


19. ABSTRACT (Continue on reverse if necessary and identify by block number) 

?"The Physio Control Defibrillator/Monitor Model LIFEPAK® 10 was tested for electromagnetic 
interference/compatibility in the UH-60A helicopter under the U.S. Army Program for Testing 
and Evaluation of Equipment for Aeromedical Operations. The tests were conducted using 
current military and industrial standards and procedures for electromagnetic interference/ 
compatibility and human factors. The LIFEPAK® 10 passed the overall evaluation and is 
validated as compatible with U.S. Army aeromedical aircraft. .-< C 


20. DISTRIBUTION/AVAILABILITY OF ABSTRACT 121 A8STRACT SECURITY CLASSIFICATION 

CO UNCLASSIFIEO/UNUMITEO □ SAME AS RPT. □ DTIC USERS I UNCLASSIFIED 


22*. NAME OF RESPONSIBLE INDIVIDUAL |22b TELEPHONE (Include Area Code) 22c. OFFICE SYMBOL 

Chief, Scientific Information Center | (205) 255-6907 SGRD-UAX-SI 


DO Form 1473, JUN 86 


Previous editions are obsolete. 


SECURITY CLASSIFICATION OF THIS PAGE 




































The authors would like to acknowledge the invaluable efforts of 
Dennis F. Shanahan, flight surgeon, USAARL; and Harold D. Moore, 
research aviator, USAARL, for their contributions to this report. 




□ □ 




Table of contents 


SECTION PAGE 

1. EXECUTIVE DIGEST 

1.1 Test objectives. 1-1 

1.2 Testing authority . 1-2 

1.3 Scope.1-2 

1.4 Material description . 1-2 

1.5 Summary.1-3 

1.6 Conclusion.1-4 

2. SUBTESTS 

2.1 Initial inspection . 2-1 

2.2 Battery life evaluation.2-1 

2.3 Electrical safety evaluation . 2-2 

2.4 Human factors evaluation (laboratory) . 2-3 

2.5 Altitude (low pressure) test.2-3 

2.6 Vibration test.2-4 

2.7 High temperature test.2-6 

2.8 Low temperature test.2-8 

2.9 Humidity test.2-9 

2.10 Electromagnetic characteristics test . 2-10 

2.11 In-flight human factors evaluation . 2-11 

2.12 In-flight EMI/EMC characteristics test . 2-12 

3. SUPPORTING DOCUMENTATION 

3.1 Detailed test information.3-1 

i 























Table of contents (Continued) 


3.2 Test data...3-3 

3.3 Criteria, significant problems, and . 3-41 

suggested improvements 

3.4 References.3-44 

3.5 Abbreviations.3-46 

3.6 Distribution list.3-48 


ii 











The Army program for Test and Evaluation of Aeromedical 
Equipment uses existing military standards (MIL-STD) and collec¬ 
tive professional expertise to test and evaluate selected medical 
equipment proposed for use aboard Army aircraft. Equipment 
meeting these standards ensures the safety of the crew, patients, 
and aircraft by eliminating risks due to: (1) interference by 
the medical equipment with aircraft systems/subsystems operation, 
(2) the aircraft system's interference with the operation of the 
medical equipment, (3) the medical equipment's susceptibility to 
environmental exposure, or (4) physical and/or functional incom¬ 
patibility while in use on board selected rotary-wing aircraft. 
This program tests both developmental and nondevelopmental (off 
the shelf) medical equipment destined for use aboard Army aero¬ 
medical aircraft. 

1.1 TEST OBJECTIVES 

1.1.1 To determine if the medical equipment is complete and 
operational per the manufacturer's operating instructions. 

1.1.2 To ensure the electrical safety of the medical equipment. 

1.1.3 To ensure the equipment will function as designed through¬ 
out the rated battery operation time. 

1.1.4 To ensure the safety of the operator, the patient, and the 
aircrew. 

1.1.5 To assess design considerations which potentially could 
contribute to an operator error. 

1.1.6 To determine if the medical equipment can function as 
designed in a low pressure environment. 

1.1.7 To determine the ability of the medical equipment to with¬ 
stand the vibrational stresses expected in a rotary-wing flight 
environment without degradation or malfunction. 

1.1.8 To determine the ability of the medical equipment to be 
stored and operated in a high temperature environment. 

1.1.9 To determine the ability of the medical equipment to be 
stored and operated in a low temperature environment. 

1.1.10 To determine the ability of the medical equipment to 
operate satisfactorily for short periods during exposure to 
highly humid conditions. 


1-1 





1.1.11 To assess the levels of electromagnetic emissions pro¬ 
duced by the medical equipment within selected frequency ranges. 

1.1.12 To assess the minimum electromagnetic susceptibility 
levels of the medical equipment within selected frequency ranges. 

1.1.13 To assess the physical and/or functional compatibility of 
the medical equipment while in use on board the aircraft. 

1.1.14 To assess the electromagnetic interference (EMI) and 
electromagnetic compatibility (EMC) characteristics of the 
medical equipment with the host aircraft and its installed 
systems. 

1.2 TESTING AUTHORITY 

Research and Technology Work Unit Summary, dated 5 October 
1989. Project number 3M462807D836, titled. Army Program for 
Testing and Evaluation of Equipment for Aeromedical Operations . 

1.3 SCOPE 

1.3.1 This test was conducted at the United States Army Aeromed¬ 
ical Research Laboratory (USAARL), Cairns Army Airfield (CAAF), 
and designated test flight areas in and around Fort Rucker, 
Alabama. 

1.3.2 The usaarl UH-60A aircraft, serial number 88-26069, with 
subsystems delineated in paragraph 3.2.2, was configured with the 
Physio Control defibrillator/monitor, model LIFEPAK® 30 and used 
as the test aircraft for the in-flight evaluation. The in-flight 
evaluation required 4.3 flight hours. 

1.3.3 Laboratory testing was accomplished at USAARL using 
government furnished equipment (GFE) by Universal Energy Systems, 
Inc. (UES), under contract No. DAMD 17-86-C-6215. 

1.3.4 Prior to flight testing, the following tests were accom¬ 
plished: Acceptance inspection, equipment training, electromag¬ 

netic compatibility, human factors and safety, environmental 
compatibility, and in-flight compatibility. 

1.3.5 An airworthiness release (AWR) dated 27 December 1990 was 
received from the U.S. Army Aviation Systems Command (AVSCOM) 
prior to the in-flight testing of the LIFEPAK® 10. 

1.4 MATERIAL DESCRIPTION 

The Physio Control LIFEPAK® 10 is a portable defibrillator, 
monitor, and optional noninvasive pacer. It is battery powered 
and contains both a cathode ray tube (CRT) cardioscope, which 


1-2 









displays real tine electrocardiographs (ECG), and two defibril¬ 
lator paddles which nay discharge any of nine selectable energy 
levels. 

1.5 SUMMARY 

1.5.1 Laboratory testing 

1.5.1.1 Battery Life Evaluation: The LIFEPAK* 10 performed 
longer than the nanufacturer specification of 45 ninutes of 
operation with a fully charged battery. Although no recharge 
tine was specified in the manufacturer's nanuals, the batteries 
were recharged in 90 ninutes in the laboratory. 

1.5.1.2 Electrical Safety Evaluation: All neasurenents were 
within acceptable limits. No unsafe qualities were found in the 
LIFEPAK* 10. The limits for currents and resistances were in 
accordance with the National Fire Prevention Association (NAFP) 
standards. 

1.5.1.3 Human Factors Evaluation: The LIFEPAK* 10 was found to 
be unsatisfactory in the conductor criteria. The cables connect¬ 
ing the defibrillator paddles interfere with the replacement of 
the paddles in their storage holders. Standards referenced 
include MIL-STD-1472D, McCormick's HFE Guide, and UL-544. 

1.5.1.4 Environmental Tests: The LIFEPAK* 10 can be expected to 
perform in a variety of environmental conditions. Its perfor¬ 
mance was found to be satisfactory in all stages of the environ¬ 
mental testing. The requirements for environmental tests are 
established in MIL-STD-810D, methods 500.2 (altitude), 514.3 
(vibration), 501.2 (high temperature), 502.2 (low temperature), 
and 507.2 (humidity). 

1.5.1.5 Radiated Emissions Tests (RE02): The LIFEPAK* 10 may be 
unsatisfactory for use in certain EMI sensitive environments. 
Narrowband (NB) and broadband (BB) radiated emissions were 
detected in the test frequency ranges. Some narrowband and 
broadband emissions exceeded the test limits. Emission limits 
are set forth in MIL-STD-461, Notice 4. 

1.5.1.6 Radiated Susceptibility Test (RS03): The LIFEPAK* 10 
was not found to be susceptible to the radiated interference 
levels in this test. Testing was not performed in the frequency 
range 10 kHz to 200 MHz due to the "in repair status" of the 
transmitter amplifier used for this range of testing. 

1.5.2 In-flioht testing 

1.5.2.1 During the in-flight human factors evaluation, the 
LIFEPAK* 10 was found to be satisfactory in all but two cate- 


1-3 



gories of the evaluation criteria. First, the human factors 
deficiency noted in the laboratory evaluation (paragraph 1.5.1.3) 
was exacerbated by the cramped quarters in the aircraft. Second, 
the inability of the flight surgeon to hear the audio alarms 
while wearing the required flight ensemble and the environmental 
noise produced by the aircraft precludes the use of the audio 
alarms. 


1.5.2.2 The aircraft and its subsystems were not adversely 
affected by the operation of the LIFEPAK* 10 in any of the pre¬ 
scribed flight test modes. 

1.5.2.3 The LIFEPAK* 10 was not affected by the aircraft and its 
subsystems during the in-flight testing. 

1.6 CONCLUSIONS 

Based on the combination of laboratory and in-flight test¬ 
ing, the LIFEPAK* 10 is validated as compatible with U.S. Army 
aeromedical UH-60A Blackhawk with the subsystems listed in 
paragraph 3.2.2. The LIFEPAK* 10 must be restricted to battery 
use only. 


1-4 




SECTION 2. _ SUBTESTS 


2.1 INITIAL INSPECTION 

2.1.1 obiastlvs 

To determine if the LIFEPAK* 10 is complete and operational 
for testing per the manufacturer's operating instructions. 

2.1.2 Cr.lt3.Elfl 

2.1.2.1 The physical inventory is conducted solely for investi¬ 
gation and documentation. 

2.1.2.2 The LIFEPAK* 10 will display a consistent and accurate 
measurement of simulated ECG signals within + 2 percent and 
deliver the programmed defibrillator energy within 1 percent. 

2.1.3 T.3 6 .t. BC9-C Sdur ,3 

2.1.3.1 A complete physical inventory of the LIFEPAK* 10 was 
completed per the manufacturer's equipment list. 

2.1.3.2 An operational validation test of the LIFEPAK* 10 was 
conducted per the manufacturer's operating instructions by 
USAARL's medical maintenance personnel. 

2.1.4 Tea t. tinsUngg 

2.1.4.1 The LIFEPAK* 10 was inventoried and found to be com¬ 
plete. 

2.1.4.2 The LIFEPAK* 10 operated as prescribed in the manufac¬ 
turer's operating manual P/N 805057-00. Criteria met. 

2.2 BATTERY LIFE EVALUATION (Laboratory) 

2.2.1 Qfr lmotive 

To ensure the equipment will function as designed throughout 
the rated battery operation time. 

2.2.2 Criterion 

Verify manufacturer's specified full power battery life 
expectancy of 45 minutes during continuous monitoring of a 
simulated ECG rate of 60 beats per minute (BPM). 


2-1 




2.2.3 Te st pr<?g g tiM re 


2.2.3.1 Charging and operation cycles were conducted in ambient 
room conditions of 23°C, 40-60 percent relative humidity (RH). 

2.2.3.2 The LIFEPAK® 10 was operated continuously using its 
three nickel-cadium (NiCad) batteries. The ECG simulator was set 
to 60 BPM and the CRT display was set for a 1.5 cm ’R' wave 
display. Monitoring was continued until all three batteries were 
depleted. Depletion times for individual batteries were noted. 

2.2.3 Test findings 

The test was conducted using three fully charged batteries. 
The average operating time in testing was 1 hour and 51 minutes 
at room temperature (75 e F and 55 percent RH). This exceeds 
manufacturer specification. Although no recharge time was 
specified in the manufacturer’s manuals, the batteries were 
recharged in 90 minutes in the laboratory. Criterion met. 

2.3 ELECTRICAL SAFETY EVALUATION 

2.3.1 Objective 

To ensure the electrical safety, by evaluation of case-to- 
ground resistance and case-to-ground current leakage, of the 
LIFEPAK® 10. 

2.3.2 Criterion 

The LIFEPAK® 10 shall meet the standards established in 
National Fire Protection Association (NFPA) 99 for electrical 
safety of medical equipment. 

2.3.3 Test procedure 

Measurements in the electrical safety evaluation were made, 
with a Neurodyne-Dempsey model 431F electrical safety analyzer, 
in accordance with the procedures described in Technical Bulletin 
(TB) Number 38-750-2. Case-to-ground resistance and various 
case-to-ground leakage currents were measured. Leakage currents 
were measured using a 10 by 20 centimeter aluminum foil sheet 
taped flush to the equipment case. Checks were made for safety 
concerns such as case integrity, breaks in power cord insulation, 
and connectors. 

2.3.4 Test findings 

Grounding conductor resistance was 41.3 milliohms and 
maximum case leakage current was 11.6 microamperes. Measurements 
were taken only on the battery charger unit for the LIFEPAK® 10. 


2-2 


External power supply connections for the LIFEPAK* 10 were not 
included for the shipped unit. These measurements are below the 
limits specified in NFPA 99. 

2.4 HUMAN FACTORS EVALUATION (Laboratory) 

2.4.1 Objectives 

2.4.1.1 To assure the safety of the operator, the potential 
patient, and the aircrew. 

2.4.1.2 To assess the design considerations which could poten¬ 
tially contribute to an operator error. 

2.4.2 Criterion 

The LIFEPAK* 10 must be rated satisfactory in all major 
categories of the evaluation. These include visual displays, 
controls, maintainability, conductors, fasteners, test points, 
test equipment, fuses and circuit breakers, labels and coding, 
and safety. 

2.4.3 Test procedure 

2.4.3.1 The evaluation was conducted in a laboratory under 
fluorescent lighting and ambient room conditions. 

2.4.3.2 The LIFEPAK* 10 was operated according to prescribed 
instructions through its full range of functions. 

2.4.4 Test finding 

The LIFEPAK* 10 was found to be unsatisfactory in one of the 
evaluation criteria: Conductors. The coiled cables connecting 
the paddles to the defibrillator interfere with the replacement 
of the paddles in their storage spaces. The two coiled cables 
cannot be stacked in the space between the paddle holders. There 
is no provision for holding these cables in place vertically 
while paddles are in use. Therefore, the cables are free to move 
into the spaces designed for paddle storage. Criterion partially 
met. 

2.5 ALTITUDE (LOW PRESSURE) TEST [IAW MIL-STD-810D, METHOD 
500.2] 

2.5.1 Objective 

To determine if the LIFEPAK* 10 can function as designed in 
a low pressure environment. 


2-3 





2.5.2 Criterion 


The LIFEPAK* 10 will display consistent 
surement of simulated ECG signals within + 2 
the programmed defibrillator energy within 1 
exposed to an altitude equivalency of 15,000 
level. 


and accurate mea- 
percent and deliver 
percent while 
feet above sea 


2.5.3 Test procedure 

2.5.3.1 A pretest performance check was conducted to ensure 
proper operation of the LIFEPAK* 10. 

2.5.3.2 The altitude test was performed in a Tenney Engineering 
model 64S altitude chamber. This test is based on MIL-STD-810D, 
Method 500.2. The LIFEPAK* 10 was placed in operation near the 
center of the floor of the chamber. The LIFEPAK* 10 was turned 
on by means of an armature through the chamber wall and made to 
monitor a signal from an ECG simulator during the test. The 
defibrillator was not discharged during this test because there 
are no provisions for operation from outside the chamber. 

Chamber pressure was decreased to 420 mm Hg (15,000 ft equivalent 
altitude) over a 15-minute period, held constant for 60 minutes, 
then raised, at 1500 fpm, to ambient conditions (760 mm Hg) over 
a 10-minute period. There are no provisions for the control of 
temperature or humidity inside this chamber. 

2.5.3.3 A posttest performance check was conducted to ensure 
proper operation of the LIFEPAK* 10 after the exposure to low 
pressure. 

2.5.4 Tjest findings 

2.5.4.1 The pretest performance check met criterion 2.1.2.2. 

2.5.4.2 No failures in the performance of the LIFEPAK* 10 were 
noted before, during, or after the altitude test. Criterion met, 

2.5.4.3 The posttest performance check met criterion 2.1.2.2. 

2.6 VIBRATION TEST (IAW MIL-STD-810D, METHOD 514.3) 

2.6.1 Objective 

To determine the ability of the LIFEPAK* 10 to withstand the 
vibrational stresses expected in a rotary-wing environment 
without degradation or malfunction. 


2-4 






2.6.2 Criterion 


While exposed to vibrational stresses, the LIFEPAK* 10 will 
remain operational and be able to display consistent and accurate 
measurement of simulated EC6 signals within ± 2 percent and 
deliver the programmed defibrillator energy within 1 percent. 

2 . 6.3 Test.jucagfldMrs 


2.6.3.1 A pretest performance check was conducted to ensure 
proper operation of the LIFEPAK* 10. 

2.6.3.2 The vibration test was performed using an Unholtz-Dickey 
model TA115-40/CSTA vibration test system. It is a single-axis 
system with an electromagnetic driver unit. The test consisted 
of sinusoidal vibrations superimposed on random vibrations over a 
frequency range of 500 Hz, as shown below. These vibrations are 
derived from measurements taken on the floor under the copilot's 
seat in a UH-1 helicopter traveling at 120 knots. The reference 
spectrum breakpoints are from MIL-STD-810D, Method 514.3; refer¬ 
ence spectrum levels are based on field measurements with a 
conservatism factor of 1.5. Independent tests were conducted in 
the X, Y, and Z axes. 


Z-axis 


duration: 60 minutes 
broadband intensity: 0.4506 G,., 
random vibration: initial slope 


5 Hz level: 
100 Hz level: 
300 Hz level: 
500 Hz level: 


99.00 dB/HZ 


0.00006210 G 


iqr/Hi 


0.0006210 G f(ll/H , 
0.0006210 G iar/H , 
0,00006210 G, vMl 


final 

slope: ■ 

-99. 

00 dB/oct 

vibration: 

.5450 

G pk 

at 

11.25 

HZ 


.1690 


at 

22.50 

HZ 


.1200 

G* 

at 

33.75 

HZ 


.0310 

Gp k 

at 

45.00 

HZ 


.0530 

Gp k 

at 

56.25 

Hz 


X and Y axes 


duration: 60 minutes each 

broadband intensity: 0.3099 G ra , 

random vibration: initial slope; 99.00 dB/oct 

5 Hz level: 0.00002920 G, 0I/t „ 
100 Hz level: 0,0002920 G, cr/Hl 
300 Hz level: 0.0002920 G ivmt 
500 HZ level: 0.00002920 G„ f/Mz 
final slope: -99.00 dB/oct 


2-5 






sinusoidal vibration: .3200 G M at 11.25 Hz 

.0670 G* at 22.50 Hz 
.0950 Gp* at 33.75 Hz 
.0350 G* at 45.00 Hz 
.0770 GU at 56.25 Hz 

The LIFEPAK* 10 was strapped to the vibration table fixture, and 
its performance was evaluated before, during, and after exposure 
to vibration. ECG signals were provided by a Valmedix simulator. 
Defibrillator discharge energy was measured with a Dynatech 
Nevada defibrillator analyzer. 

2.6.3.3 A posttest performance check was conducted to ensure 
proper operation of the LIFEPAK* 10. 

2.6.4 Test findings 

2.6.4.1 The pretest performance check met criterion 2.1.2.2. 

2.6.4.2 No failures in the performance of the LIFEPAK* 10 
occurred before, during, or after exposure to vibration. Maximum 
artifact of 1 mm was observed on ECG display and strip chart 
recordings during vibration exposure in the X and Y axes. 

Maximum artifact in the Z-axis was 2 mm. These vibration arti¬ 
facts may obscure fine details (P, Q, and S waves) in a low 
amplitude ECG signal. However, heart rate and R wave detection 
were not compromised. Criterion met. 

2.6.4.3 The posttest performance check met criterion 2.1.2.2. 

2.7 HIGH TEMPERATURE TEST [IAW MIL-STD-810D, METHOD 501.2] 

2.7.1 objective 

To determine the ability of the LIFEPAK* 10 to be stored and 
operated in a high temperature environment. 

2.7.2 criteria 

2.7.2.1 During the high temperature operation check, the 
LIFEPAK* 10 must display consistent and accurate measurement of 
simulated ECG signals within ± 2 percent and deliver the program¬ 
med defibrillator energy within 1 percent. 

2.7.2.2 After the high temperature storage cycle, the LIFEPAK* 

10 must be able to display consistent and accurate measurement of 
simulated ECG signals within ± 2 percent and deliver the program¬ 
med defibrillator energy within 1 percent. 


2-6 





2 . 7.3 Test procedure 


2.7.3.1 A pretest performance check was conducted to ensure 
proper operation of the LIFEPAK* 10. 

2.7.3.2 The high temperature test was conducted in a Tenney 
Engineering model ZWUL-10107D walk-in controlled environment 
chamber. This test is based on MIL-STD-810D, Method 501.2. For 
the high temperature operation test, the LIFEPAK* 10 was placed 
in operation on a wire test stand near the center of the 
environmental chamber. The ECG leads were routed through a 
portal in the chamber wall to a Valmedix ECG simulator. Defib¬ 
rillator energy was measured with a Dynatech Nevada defibrillator 
analyzer. The chamber temperature was raised to 49*C and the 
humidity was stabilized at a maximum of 20 percent RH within 15 
minutes. The environmental control system is capable of regulat¬ 
ing temperature within ±2*C and humidity within ±5 percent RH. 
Temperature and humidity were held constant for 2 hours. At 30- 
minute intervals, the chamber door was opened briefly to minimize 
the change in chamber conditions during performance checks. 

After the operational test, the LIFEPAK* 10 was allowed to return 
to ambient conditions over a 30-minute period. 

2.7.3.3 A posttest performance check was conducted to ensure 
proper operation of the LIFEPAK* 10. 

2.7.3.4 The LIFEPAK* 10 was stored (not operated) at tempera¬ 
tures of 63*C for 1 hour, 71‘C for 4 hours, then again at 63"C 
for 1 hour. The ECG cable was coiled and placed on top of the 
defibrillator/monitor and the paddles were stored in their 
holders. The chamber and LIFEPAK* 10 then were returned to 
ambient conditions over a 30-minute period. 

2.7.3.5 A poststorage performance check was conducted to ensure 
proper performance of the LIFEPAK* 10. 

2.7.4 Test, findi ng s 

2.7.4.1 The pretest performance check met criterion 2.1.2.2. 

2.7.4.2 No operational failures occurred during the high temper¬ 
ature test. Criterion met. 

2.7.4.3 The posttest performance check met criterion 2.1.2.2. 

2.7.4.4 The LIFEPAK* 10 functioned properly after the high 
temperature storage test. Criterion met. 


2-7 




2.8 LOW TEMPERATURE TEST [IAW MIL-STD-810D, METHOD 502.2] 

2.8.1 Objective 

To determine the ability of the LIFEPAK* 10 to be stored and 
operated in a low temperature environment. 

2.8.2 Criteria 

2.8.2.1 During the low temperature operation check, the LIFEPAK* 
10 must display consistent ar.u accurate measurement of simulated 
ECG signals within + 2 percent and deliver the programmed defi¬ 
brillator energy within 1 percent. 

2.8.2.2 After the low temperature storage cycle, the LIFEPAK* 10 
must be able to display consistent and accurate measurement of 
simulated ECG signals within ± 2 percent and deliver the pro¬ 
grammed defibrillator energy within 1 percent. 

2.8.3 Test procedure 

2.8.3.1 A pretest performance check was conducted to ensure 
proper operation of the LIFEPAK* 10. 

2.8.3.2 The LIFEPAK* 10 was placed on the floor of the environ¬ 
mental chamber and the temperature was lowered to 0’C within 25 
minutes. The environmental control system is capable of regulat¬ 
ing temperature within 2*C. Humidity cannot be controlled in the 
chamber at freezing temperatures. The temperature was held 
constant for 2 hours. The chamber door was opened briefly, to 
minimize the change in chamber conditions, every 30 minutes and a 
performance check was conducted. The chamber temperature then 
was raised to ambient temperature within a 30-rcinute period. 

2.8.3.3 A posttest performance check was conducted to ensure 
proper operation of the LIFEPAK* 10. 

2.8.3.4 The LIFEPAK* 10 was "stored" in a nonoperational mode 
with the power cord coiled and placed on top of the LIFEPAK* 10. 
The LIFEPAK* 10 was placed on the floor of the environmental test 
chamber and the temperature was lowered to -46°C for 6 hours. 

The chamber then was raised to ambient temperature over a 30- 
minute period. 

2.8.3.5 A poststorage perfcrmance check was conducted to ensure 
proper operation of th> LIFEPAK* 10. 

2.8.4 Test findings 

2.8.4.1 The pretest performance check met criterion 2.1.2.2. 


2-8 


2.8.4.2 No operational failures occurred during the low tempera 
ture test. Criterion met. 

2.8.4.3 The posttest performance check met criterion 2.1.2.2. 

2.8.4.4 The LIFEPAK® 10 functioned properly after the low 
temperature storage test. Criterion met. 

2.9 HUMIDITY TEST [IAW MIL-STD-810D, METHOD 507.2] 

2.9.1 Objective 

To determine the ability of the LIFEPAK® 10 to operate 
satisfactorily for short periods of time during exposure to 
highly humid conditions. 

2.9.2 Criterion 


While exposed to a high humidity environment, the LIFEPAK® 

10 must display consistent and accurate measurement of simulated 
ECG signals within ± 2 percent and deliver the programmed defi¬ 
brillator energy within 1 percent. 

2.9.3 Test procedure 

2.9.3.1 A pretest performance check was conducted to ensure the 
proper operation of the LIFEPAK® 10. 

2.9.3.2 The humidity test was conducted in a Tenney Engineering 
model ZWUL—10107D walk-in controlled environment chamber. This 
test is based on MIL-STD-810D, Method 507.2. For the humidity 
test, the LIFEPAK® 10 was placed in operation on a wire test 
stand near the center of the environmental chamber. The ECG 
leads were routed through a portal in the chamber wall to a 
Valmedix ECG simulator. Defibrillator energy levels were 
measured with a Dynatech Nevada defibrillator analyzer. The 
chamber temperature was raised to a temperature of 29.5'C and a 
relative humidity of 95 percent within 25 minutes. Temperature 
and relative humidity were maintained for 4 hours. The environ¬ 
mental control system is capable of regulating temperature within 
±2*C and humidity within ±5 percent RH. At 45-minute intervals 
the defibrillator/monitor performance was checked. The chamber 
door was opened briefly to minimize the change in chamber condi¬ 
tions. The chamber and the LIFEPAK® 10 were returned to ambient 
conditions before the posttest performance validation check was 
conducted. 

2.9.3.3 A posttest performance check was conducted to ensure the 
proper operation of the LIFEPAK® 10. 


2-9 






2.9.4 Test findings 

2.9.4.1 The pretest performance check met criterion 2.1.2.2. 

2.9.4.2 No failures were noted in the LIFEPAK® 10 performance 
checks conducted during the exposure to the high humidity en¬ 
vironment. Criterion met. 

2.9.4.3 The posttest performance check met criterion 2.1.2.2. 

2.10 ELECTROMAGNETIC CHARACTERISTICS TEST [IAW MIL-STD-461A, 
Notice 4, MIL-STD-462, Notice 3, and MIL-STD-704C] 

2.10.1 Objectives 

2.10.1.1 To assess the maximum levels of radiated electromag¬ 
netic emissions produced by the LIFEPAK® 1C in the 14 kHz to 1.0 
GHz frequency range. 

2.10.1.2 To assess the tolerances of radiated electromagnetic 
susceptibility of the LIFEPAK® 10 within the 10 kHz to 10 GHz 
broadband electric field and the 14 kHz to 12.4 GHz narrowband. 

2.10.2 Criteria 

2.10.2.1 The LIFEPAK® 10 shall not produce emissions in excess 
of the limits set forth in MIL-STD-461A, Notice 4, paragraph 
6.13. 


2.10.2.2 The LIFEPAK® 10 shall not malfunction when it is sub¬ 
jected to radiated emissions as specified in MIL-STD-461A, Notice 
4, paragraph 6.20. 

2.10.3 T est procedure 

2.10.3.1 The radiated emissions test was performed according to 
MIL-STD-462, Notice 3, Method RE02. The LIFEPAK® 10 was posi¬ 
tioned on a wooden test stand 1 meter tall, 0.18 meters wide, and 
0.21 meters long, inside the EMI chamber. The unit was directly 
in line with, and at a horizontal distance of 1 meter from the 
receiving antennas. The antennas were mounted for both vertical 
and horizontal polarities and connected to the appropriate EMI 
receivers. Electrometries EMC-25 and EMC-50 receivers were used 
for this test. Their frequency ranges in testing are 14 kHz to 1 
GHZ and 1 to 12.4 GHz. Broadband and narrowband detection 
methods were used from 14 kHz to 1 GHz. Narrowband detection 
methods were used from l GHz to 12.4 GHz. The monitor operated 
continuously while displaying ECG signals provided by a Valmedix 
ECG simulator. The defibrillator was charged to 100 joules and 
discharged into a Dynatech Nevada defibrillator analyzer at 20- 
second intervals. 


2-10 





2.10.3.2 The radiated susceptibility test was performed accord¬ 
ing to MIL-STD-462, Notice 3, Method RS03. The LIFEPAK* 10 was 
positioned on a wooden test stand 1 meter tall, 0.18 meters wide, 
and 0.21 meters long, inside the EMI chamber. The unit was 
directly in line with, and at a horizontal distance of l meter 
from the transmitting antennas. The antennas were mounted for 
both vertical and horizontal polarities and connected to radio 
frequency (RF) transmitters. The defibrillator/roonitor was 
exposed to fields of 10 V/m from 200 MHz to 2 GHz, and 5 V/m from 
2 to io GHz. The LIFEPAK* io was not tested in the frequency 
range 10 kHz to 200 MHz because the transmitter necessary for 
these frequencies was out for repair. All RF carrier waves were 
50 percent amplitude modulated with a 1000 Hz tone. The ECG 
leads were routed through a wave guide tube through the chamber 
wall. ECG signals were provided by a Valmedix ECG simulator. 

The defibrillator was in standby mode during this test. 

2.10.4 Test findings 


2.10.4.1 During the radiated emissions test, narrowband and 
broadband emissions which exceeded specification limits of MIL- 
STD-461, Notice 4, were detected in the frequency ranges below. 

Frequency Amount of failure 


191 kHz - 
7.46 - 

191 kHz - 
200 


3.83 MHz 
829.82 MHz 
3.83 MHZ 
875 MHZ 


3.8 - 40.6 dB (NB) 
1.4 - 48.1 dB (NB) 
0.9 - 24.5 dB (BB) 

1.9 - 39.4 dB (BB) 


Criterion partially met. 


2.10.4.2 The LIFEPAK* 10 was not found to be susceptible to any 
fields generated during this test. No abnormalities were noticed 
in defibrillator/monitor operation as a result or exposure to the 
test fields. Criterion met. 


2.11 IN-FLIGHT HUMAN FACTORS EVALUATION 

2.11.1 Objective 

To assess the physical and/or functional compatibility of 
the LIFEPAK* 10 while in use onboard the aircraft. 

2.11.2 Criterion 

The flight surgeon shall be able to operate the LIFEPAK* 10 
without physical or functional restrictions aboard the aircraft. 
Major areas of concern include: Proper operation, visual dis¬ 
plays, controls, maintainability, conductors, fasteners, test 


2-11 





points, test equipment, fuses and circuit breakers, labels and 
coding, and safety. 

2.11.3 Test procedure 

2.11.3.1 A human factors evaluation was performed in accordance 
with MIL-STD-1472D, McCormick’s Human Factors Evaluation Guide, 
and UL-544 to ensure the compatibility of the LIFEPAK* 10 and the 
in-flight environment. The flight surgeon conducted the test 
wearing a flight suit, flight gloves, and an SPH-4 flight helmet. 
An evaluation of the compatibility with the nuclear, biological, 
and chemical (NBC) protective equipment was not conducted. 

Due to restrictions of the AWR, testing was conducted during 
daylight hours only. 

2.11.3.2 The LIFEPAK* 10 was placed on the top pan of the litter 
carousel which was configured for four patients. The litter 
carousel was flown in the "load" position (perpendicular to the 
long axis of the helicopter). The LIFEPAK* 10 was tested in both 
the defibrillation and monitoring modes in all flight scenarios 
required by the In-Flight Test Operations Procedures (ITOP) 

(refer to section 3.2). 

2.11.4 Test findings 

During the in-flight human factors evaluation, the LIFEPAK* 
10 was found to be satisfactory in all but two categories of the 
evaluation criteria. First, the deficiency noted in the labora¬ 
tory evaluation (paragraph 1.5.1.3) was exacerbated by the 
cramped quarters in the aircraft. Second, the flight surgeon was 
unable to hear the audio alarms while wearing the required flight 
ensemble. However, all audio alarms on the LIFEPAK* 10 are 
backed up by visual alarms which are acceptable, criterion 
partially met. 

2.12 IN-FLIGHT EMI/EMC CHARACTERISTICS 

2.12.1 Objective 

To assess the EMI/EMC characteristics of the LIFEPAK* 10 
with the host aircraft and its installed systems. 

2.12.2 geltaria 

2.12.2.1 The LIFEPAK* 10 shall not radiate EMI to disrupt or 
interfere with other equipment or systems aboard the aircraft. 

2.12.2.2 The aircraft shall not radiate EMI to disrupt or 
interfere with the LIFEPAK* 10's operation. 


2-12 





2.12.3 Test procedure 


A qualitative EMI/EMC assessment was performed with both the 
LIFEPAK® 10 and the aircraft operating as source and victim. The 
LIFEPAK® 10 and applicable aircraft instruments and systems were 
monitored for unusual operation, readings, surges, or power 
anomalies for each checklist item (see pages 3-5 through 3-8). 

2.12.4 Test findings 

2.12.4.1 There were no adverse instances of EMI/EMC noted with 
the LIFEPAK® 10 acting as either the source or victim. Criterion 
met. 


2.12.4.2 There were no adverse instances of EMI/EMC noted with 
the aircraft acting as either the source or victim. Criterion 
met. 


2-13 



SECTION 3 t_ SUPPORTING DOCUMENTATION 


3.1 DETAILED TEST INFORMATION 

3.1.1 General information 

3.1.1.1 LIFEPAK* 10 testing is not considered a major action 
significantly affecting the quality of the human environment and 
therefore qualifies for categorical exclusion A-28, appendix A, 
AR 200-1. 


3.1.1.2 A safety pilot will be designated for each flight. 

Flight operations will be conducted in accordance with (IAW) the 
aircraft operator's manual, appropriate aircrew training manuals, 
and test item technical data. 

3.1.2 Material description 

3.1.2.1 The Physio Control LIFEPAK* 10 is a portable defibril¬ 
lator, monitor, and optional noninvasive pacer. The LIFEPAK* 10 
is powered from one of the three rechargeable "FASTPAK" NiCad 
batteries included in the unit. Power is controlled with a 
green, five-position rotary switch labeled "1 POWER" located on 
top of the unit case. The rotary switch allows the operator to 
select one of the three batteries or an optional auxiliary 
external power source labeled "AUX" (not included in testing). 
Each battery select switch position has an adjacent red lamp that 
flashes to indicate a low battery or is continuously illuminated 
to indicate a depleted battery. 

The electrocardiograph (ECG) monitor has a nonfade cathode 
ray tube (CRT) cardioscope which displays real time ECG. Digital 
indications of heart rate are displayed on a liquid crystal 
display (LCD). Two rocker switches, spring-loaded center-off, on 
the front panel of the monitor are labeled, "ECG SIZE" and "QRS 
VOLUME". Depressing the left side of the switches decreases ECG 
size or QRS volume and depressing the right side of the switches 
increases the ECG size or QRS volume. A pushbutton on/off switch 
labeled "CAL" on the front panel superimposes a 1 mV pulse on the 
cardioscope and recorder traces. A pushbutton on/off switch 
labeled "LEAD SELECT" on the front panel allows the operator to 
select the ECG input mode. Pressing the "LEAD SELECT" button 
will advance the input mode through paddles, lead I, lead II, and 
lead III. A pushbutton on/off switch labeled "RECORDER" on the 
front panel activates and deactivates the thermal array recorder 
on top of the monitor. This recorder operates in a 3-second 
delay mode. A pushbutton on/off switch labeled "CODE SUMMARY" on 
the front panel activates and deactivates the thermal array 
recorder to provide printed documentation of critical events on 
the strip chart. A pushbutton on/off switch labeled "FREEZE" on 


3-1 





the front panel allows the operator to freeze the trace on the 
cardioscope as long as the pushbutton is held down. A pushbutton 
switch labeled "SYNC” on the front panel selects the synchronized 
discharge mode of defibrillation and "SYNC" is displayed on the 
LCD. Patient connection is made through a 6-pin Physio Control 
patient cable connector. 

The defibrillator paddles are stored horizontally in slots 
on the front panel. Nine energy levels of 0, 5, 10, 20, 50, 100, 
200, 300, and 360 joules cire selected by a rotary switch labeled 
"2 ENERGY JOULES" located on. the sternum (left hand) paddle. A 
round, yellow pushbutton switch on the apex (right hand) paddle 
labeled "CHARGE" allows the operator to initiate the defibril¬ 
lator charge cycle. A round, grey pushbutton switch on the apex 
paddle labeled "RECORDER" activates the thermal recorder on the 
monitor. A digital readout, on the LCD indicates available energy 
when the defibrillator is energized. Round, red pushbuttons on 
the front of ea •addle discharge the defibrillator when they 
are pressed sir,. reously. 

3.1.2.2 Method of Operation: The LIFEPAK® 10 power switch ener¬ 
gizes the monitor and defibrillator. The ECG leads selector will 
be set for "LEAD II" upon startup. The lead selector mode is 
displayed on the LCD screen below the heart rate readout. The 
incoming ECG signal travels through the three-lead ECG cable to 
the preamp circuitry in the monitor where it is amplified and 
digitized. The signal then is filtered through the defibril- 
lator/ECG microcomputer which s .res the digital ECG waveform to 
be displayed on the CRT. System integrity is monitored continu¬ 
ously by microprocessors which check read only memory (ROM), 
random access memory (RAM), and software module check sums. The 
monitor is controlled by a main control panel with pushbuttons 
that provide logic signals to an executive microprocessor. The 
defibrillator 1 operates by reading the selected energy setting 
from the rotary dial on the sternum paddle when the charge button 
is pressed. A high voltage capacitor then is charged to the 
appropriate level. When the selected level has been reached, an 
audible tone sounds and the yellow charging light emitting 
display (LED) on the sternum paddle switches from flashing to 
continuous illumination. When the two round, red discharge 
buttons — located on the front of the paddles — are pressed 
simultaneously, contacts in the transfer relay deliver high 
voltage to the paddles. Depressing one discharge button alone 
will not activate the transfer relay. Selecting another charge 
level with the rotary dial on the sternum paddle after the 
capacitor is charged will cause the capacitor to discharge 
internally. Energy discharge through both paddles is controlled 
solely by the paddle discharge buttons. 


7 


REPRODUCED FROM 
BEST AVAILABLE COPY 



3♦2 TEST DATA 

3.2.1 Photograp hic Description 



LIFEPAK*10 with paddles stored. 



LIFEPAK*10 showing cable interference with paddle replacement. 







3.2.2 Aircraft equipment list 


Item No. 


Nomenclature 


1 

2 

3 

4 

5 

6 

7 

8 
9 

10 

11 

13 

14 

15 

16 

17 

18 

19 

20 
21 
22 

23 

24 

25 


Receiver radio - R-1496A/ARN-89 
(automatic direction finder) 

Displacement gyro - CN-1314/A 
Gyro directional - CN-998/ASN-43 
Signal data converter - CV-3338/ASN-128 
Receiver - R-2139/ARN-123 
(VOR/LOC/MB/GS) 

Command instrument system processor - 70600-01038- 
101 

SAS amplifier - 70901-02908-104 

(flight control stability augmentation system) 

Rate gyro - TRU-2A/A 

Amplifier, impedance - AM-4859A/ARN-89 
Cargo hook - FE-7590-145 
Receiver, radar - RT-1193/ASN-128 
(doppler navigation receiver) 

Barometric altimeter - AAU-31/A-1 
Barometric altimeter - AAU-32A 
Receiver/transmitter - RT-1300/ARC-186 
(VHF-AM and/or FM radio) 

UHF-AM radio set - RT-1518/ARC-164 
Interphone control - C6533/ARC 
(aircraft intercom control) 

Receiver/transmitter - RT-1115D/APN-209 
(radar altimeter) 

Indicator altimeter - ID-1917C/APN-209 
(radar altimeter) 

Control radio set - C-7392A/ARN-89 
(automatic direction finder) 

Comparator signal data - CM-482/ARC-186 
(comparator for ARC-186) 

Receiver/transmitter - RT-1296A/APX-100 
(transponder with IFF) 

Computer display unit - CP-1252/ASN-128 
(ioppler navigation system) 

Compass set controller - C-8021E/ASN75 
Magnetic compass - standby - MS-17983-4 


3-4 





3.2.3 In-flight test data card 


DATA CARD FORMAT 

GUIDELINE FOR DATA COLLECTION 

IN-FLIGHT SUITABILITY TEST OF MEDICAL ITEMS 

1. Installation/removal. Suitable 

Yes No 

a. Weight and balance X 

(DD Form 365-4, Clearance 

Form F). 

b. Space/area allocation. 


(1) Operational X 

requirements. 

(2) Storage requirements. X 

c. Interface connections X 

(safe, positive, secure). 

d. Installation/removal X 

(expedient/easily achieved). 

e. Mounting/final config- X 

uration (functional/stable). 

2. Operations and performance. Suitable 

Yes No 

a. Manufacturer's operating X 

instruction. 

b. Medical item operation X 

before aircraft runup. 

c. System interface during X 

aircraft engine runup and 

medical item operation (EMI 
switchology checklist). 

(1) Aircraft voltage X 

output. 


3-5 


Comments 


Comments 




(2) Flight control Suitable 

function (UH-60). Yes No 

(3) Stabilator function X 

(UH-60). 

(4) Radio communication 
vs medical item operation. 


(a) FM X 

(b) UHF X 

(c) VHF X 

(5) Navigation equipment 
vs medical item operation. 

(a) Transponder X 

(b) ADF X 


(c) VOR 


X 


(d) DOPPLER X 

(6) Radar altimeter X 

operation vs medical 
item operation. 

d. System interface during air¬ 
craft hover and medical item 
operation (EMI switchology check¬ 
list) . 

(1) Voltage output. n/a 

(2) Radio communication vs 
medical item operation. 

(a) FM X 

(b) UHF X 

(c) VHF X 


Comments 


3-6 



(3) Navigation equipment Suitable 

operation vs medical item Yes No 

operation. 

(a) Transponder X 

(b) ADF X 

(c) VOR X 

(d) DOPPLER X 


e. Flight mission profile vs 
medical item operation (EMI 
switchology checklist). 

(1) Straight and level 
(1000 ft MSL for 20 
minutes). 

(a) Compatibility of X 

flight mode and 

medical item operation. 

(b) Radio communication 


vs medical item opera¬ 
tion. 

a. fm x 

fa. UHF X 

fi. VHF X 

(2) NOE (20 minutes). X 

compatibility of flight 

mode and medical item 
operation. 

(3) FM homing (10 minutes). X 

(4) DOPPLER navigation vs 
medical item operation. 

(a) Initialize X 

function. 

(b) Fix function. X 

(c) Update function. X 


Comments 


3-7 









Suitable 
Yes No 


Comments 


(5) VOR navigation 

7000 ft MSL for 20 
minutes) vs medical 
item operation. 

X 

(6) ILS approach vs 
medical item operation. 

X 

f. Medical item operation 
after engine shutdown 
(external power source). 

X 

g. Restrictions to the 
medical item's use (i.e., 
electrical connectors). 

h. Deviations from the labor¬ 
atory test results. 

X 

(1) Electrical/ 
electronic. 

None 

(2) Mechanical 
environment. 

None 

(3) Human factors 

(user interface, controls, 

markings, lighting, egress). 

None 

(4) Safety. 

None 


3. Deviations from the in-flight test protocol. 

a. The VOR navigation portion of the in-flight test con¬ 
ducted at 2000 feet MSL due to air traffic control clearance. 


3-8 




m 









3.2.4 EMI switcholocrv checklist 


EMI SWITCHOLOGY CHECKLIST UH-60 AIRCRAFT 
IN-FLIGHT SUITABILITY OF MEDICAL ITEMS 


ENG INSTRUMENTS/CDU 

No EMI 

EMI Affected 

Explanation 


Affect 

Gnd Fit 


Fuel quantity 

X 



Fuel indicator test 

X 



XMSN oil temperature 

X 



XMSN oil pressure 

X 



#1 engine oil temperature 

X 



#2 engine oil temperature 

X 



#1 engine oil pressure 

X 



#2 engine oil pressure 

X 



#1 TGT 

X 



#2 TGT 

X 



#1 Ng speed 

X 



#2 Ng speed 

X 



CDU digits on/off 

X 



CDU instruments dim 

X 



ENG INSTRUMENTS/PLT PDU 

No EMI 

EMI Affected 

Explanation 


Affect 

Gnd Fit 


#1 engine RPM 

X 



#2 engine RPM 

X 



Rotor RPM 

X 



#1 torque 

X 



#2 torque 

X 



ENG INSTRUMENTS/COPLT PDU 

No EMI 

EMI Affected 

Explanation 


Affect 

Gnd Fit 


#1 engine RPM 

X 



#2 engine RPM 

X 



Rotor RPM 

X 



#1 torque 

X 



#2 torque 

X 




3-9 




ENG CONTROLS 


#1 overspeed 
#2 overspeed 
RPM switch 
#1 engine anti-ice 
#2 engine anti-ice 
#1 inlet anti-ice 
#2 inlet anti-ice 

RADIO EQUIPMENT 


ICS, C-6533 ARC 
VHF-FM, ARC-186/115 
VHF-AM, ARC-186/115 
UHF-AM, ARC-164(V) 

Crypto, KY-28 
Radio retransmissions PLN 
Transponder, APX-IOO(V) 
KIT-1A/TSEC IFF computer 

MISSION EQUIPMENT 


RWR, APP-39(V) 

IR CM, ALQ-144 
Chaff dispenser, M-130 
Cargo hook system 

HYDRAULIC CONTROL SYSTEM 


Backup hydraulic pump 
Servo off 1st stage/PLT 
Servo off 2nd stage/PLT 
Servo off 1st stage/COPLT 
Servo off 2nd stage/COPLT 
Hydraulic leak test 
Tail servo 
Boost servos 


No EMI EMI Affected 
Affect Gnd Fit 

X 

X 

X 

X 

X 

X 

X 

No EMI EMI Affected 
Affect Gnd Fit 

X 

X 

X 

X 

Not installed 
Not installed 
X 

Not keyed with code 

No EMI EMI Affected 
Affect Gnd Fit 

Not installed 
Not installed 
Not installed 
X 

No EMI EMI Affected 
Affect Gnd Fit 

X 

X 

X 

X 

X 

X 

X 

X 


Explanation 


Explanation 


Explanation 


Explanation 


3-10 


FUEL SYSTEM 


NO EMI EMI Affected 
Affect Gnd Fit 


Fuel pump switch 
Fuel boost pump #1 
Fuel boost pump #2 
Fuel cont panel ESSS 

WARNING SYSTEM 


Low rotor RPM 
Master caution 
Caution advisory 
Fire warning 
AFCS 

Stabilator 
#1 engine out 
#2 engine out 

NAVIGATION INSTRUMENTS 


ADF 

Magnetic compass 
CONUS NAV, ARN-123 
DOPPLER, ASN-128 
Gyro mag compass (PLT) 

Gyro mag compass (COPLT) 
Compass cont panel, ASN-75 
HSI 

FLIGHT INSTRUMENTS 


Radar altimeter 
Stabilator pos indicator 
VS I 

CIS mode select 

SAS 1 

SAS 2 

FPS 

Trim 

Go-around enable 
Cyclic trim release 
Cyclic stick trim 
ALR encoder 


X 

X 

X 

Not installed 

No EMI EMI Affected 
Affect Gnd Fit 

X 

X 

X 

X 

X 

X 

X 

X 

No EMI EMI Affected 
Affect Gnd Fit 

X 

X 

X 

X 

X 

X 

X 

X 

No EMI EMI Affected 
Affect Gnd Fit 

X 

X 

X 

X 

X 

X 

X 

X 

X 

X 

X 

X 


Explanation 


Explanation 


Explanation 


Explanation 


3-11 



FLIGHT INSTRUMENTS (CONT) 

No EMI 

EMI Affected 

Explanation 


Affect 

Gnd Fit 


HSI/VSI mode select (PLT) 




DPLR 

X 



VOR/ILS 

X 



BACK CRS 

X 



FM HOME 

X 



TURN RATE 

X 



CRS HDG 

X 



VERT GYRO 

X 



BRG 2 

X 



HSI/VSI Mode Select (COPLT) 




DPLR 

X 



VOR/ILS 

X 



BACK CRS 

X 



FM HOME 

X 



TORN RATE 

X 



CRS HDG 

X 



VERT GYRO 

X 



BRG 2 

X 



MISCELLANEOUS EQUIPMENT 

No EMI 

EMI Affected 

Explanation 


Affect 

Gnd Fit 


Blade de-ice 

Not tested 

Ambient 




tempera¬ 
ture was 
out of 
test 
limits. 

Windshield anti-ice 

X 



Pilot heat 

X 



Vent blower 

X 



Windshield wiper 

X 



Heater 

X 



APU 

X 



Generator #1 

X 



Generator #2 

X 



Generator APU 

X 



Air source heat start 

X 



Tail wheel lock 

X 



Gyro erect 

X 




3-12 





LIGHTING 

No EMI 

EMI Affected Explanation 


Affect 

Gnd Fit 


Cockpit utility X 
Cockpit flood X 
Cabin dome X 
Search light X 
Search light control X 
Landing light X 
Fit instr lights (PLT) X 
Fit instr lights (COPLT) X 
Nonflight instr lights X 
Console lights, upper X 
Console lights, lower X 
Position lights X 
Formation lights X 
Anticollision lights X 
NVG lighting X 


3-13 




3.2.5 Battery life evaluation 


Battery Life Evaluation 
Report Form 

Nomenclature: Defibrillator/Monitor 
Manufacturer: Physio Control 
Model number: LIFEPAK* 10 
Serial number: 00004322 
Military item number: None 

Options installed: None 

Manufacturer battery life specification: 

45 minutes in monitor mode 
Specified battery recharge time: 

none; information not provided in manuals 
Specified mode of operation under battery power: 

monitoring of ECG signal at 60 BPM 
Overall performance: Pass 

Measurements: 


Dates of first test: 

27 Dec 

90 


Temperature: 

22 * C 



Humidity: 

50% RH 



Start times: 

0902 



End times: 

1059 



Operating times: 

1 hour 

57 

minutes 

*********************** 



Total operating time: 

1 hour 

57 

minutes 

Performance: 

Pass 



Dates of second test: 

27 Dec 

90 


Temperature: 

2 3 ° C 



Humidity: 

65% RH 



Start times: 

0927 



End times: 

1118 



Operating times: 

1 hour 

51 

minutes 

*********************** 



Total operating time: 

1 hour 

51 

minutes 

Performance: 

Pass 




3-14 



Dates of third Test: 
Temperature: 

Humidity: 

Start times: 

End times: 

Operating times: 
********************* 

Total operating time: 
Performance: 


27 Dec 90 
23*C 
65% RH 
1337 
1518 

1 hour 41 minutes 

1 hour 41 minutes 
Pass 


Comments: The unit averaged 1 hour 49 minutes of 
operation. 








3.2.6 Electrical safety test 


Electrical Safety Test 
Report Form 

Nomenclature: Defibrillator/monitor 
Manufacturer: Physio Control 
Model number: LIFEPAK* 10 
Serial number: 00004322 
Military item number: None 

Line cord identification: Northwire, Inc., 16/3, SJT 
Options installed: None 

Date of test: 21 Dec 90 

Measurements: 

Grounding conductor resistance (milliohms): 41.3 

Leakage current - Case to ground (microamps): 

unit off, grounded, normal polarity N/A 

unit off, ungrounded, normal polarity N/A 
unit off, ungrounded, reverse polarity N/A 

unit on, grounded, normal polarity 5.0 

unit on, ungrounded, normal polarity 11.6 

unit on, ungrounded, reverse polarity 6.0 

MAXIMUM LIMITS: 

ground resistance: 150 milliohms 
current (grounded, type A unit): 10 
current (ungrounded, type A unit): 100 
current (grounded, type B unit): 50 
current (ungrounded, type B unit): 500 

Comments on item set-up or checks: 

The test was conducted on the battery charger. The 
charger does not have a power switch (always on when 
plugged in). The defibrillator/monitor is 
completely battery powered with no external power 
conductors. 

Comments on test run (including interruptions): 

Metal foil was used for leakage current tests on the 
charger. It does not have an external grounded 
metal surface. The ground conductor resistance was 
measured at the AC cord connector. 


3-16 



Comments on other data: 


Additional tests for defibrillators 

Current to paddles ( ), EUT off: N/A 
(G, NP) (UG, NP) (UG, RP) 

Current to paddles ( ), EUT on: N/A 
(G, NP) (UG, NP) (UG, RP) 


Output energy (watt-seconds): 


Control 

Energy 

Energy 


setting 

indicated 

delivered 

(Battery) 

10 

10 

N/A 

10 

20 

20 

N/A 

20 

50 

50 

N/A 

50 

100 

100 

N/A 

101 

200 

200 

N/A 

196 

300 

300 

N/A 

296 

360 

360 

N/A 

354 

Maximum time to 

full charge 

(seconds), AC: N/A 

DC: 10 

Maximum time for 

synchronized discharge (mS): 

27 

Comments on item 

set-up or 

checks: 


Comments on test 

run (including interruptions) 

• 

• 


Comments on other data: 


3-17 




3.2.7 Human factors evaluation 


Human Factors Evaluation 
Report Form 

Nomenclature: Defibrillator/Monitor 
Manufacturer: Physio Control 
Model number: LIFEPAK* 10 
Serial number: 00004322 
Military item number: None 

Options installed: None 

Date of test: 27 Dec 90 

Item configuration during test: 

Prepared for operation, sitting on a countertop. 


Checklist for HFE 


RESULTS 

VISUAL DISPLAYS: Satisfactory 

PASS: display type, format, content 

PASS: location of displays 

PASS: indicator lights 

PASS: scalar displays 

PASS: color coding 

PASS: legends and labels 

PASS: cathode ray tubes 

PASS: counters 

PASS: flags, go/no go, center-null indicators 

Comments: 


CONTROLS: Satisfactory 

PASS: location 

PASS: characteristics of controls 
PASS: labeling 

PASS: control - display relationships 


3-18 



Comments: 


TIME REQUIRED TO PREPARE FOR OPERATION (list in comment) 
Comments: Approximately 10 minutes 


MAINTAINABILITY: Satisfactory 

PASS: component location 
PASS: component characteristics 
PASS: rests & stands 
PASS: covers, cases, access doors 
PASS: handles 
N/A : lubrication 
PASS: component mounting 
PASS: cord storage provisions 
PASS: external accessibility 
PASS: internal accessibility 

NONE: list special tools required 

* : list realistic inspection requirements 

** : list realistic inspection intervals 

Comments: * daily check of operation and accessories 
** quarterly preventive maintenance 


CONDUCTORS: Unsatisfactory 

PASS: binding & securing 
PASS: length 
PASS: protection 
FAIL: routing 
PASS: conductor coding 
PASS: fabrication 

PASS: connectors 

Comments: Paddle cables interfere with the replacement 
of the paddles in their storage area. 


FASTENERS: Satisfactory 

PASS: access through inspection panel covers 

PASS: enclosure fasteners 

PASS: device mounting bolts & fasteners 

Comments: 


3-19 




TEST POINTS: 


N/A 


N/A : general 

N/A : location & mounting 

N/A : test point labeling & coding 

Comments: 


TEST EQUIPMENT: Satisfactory 

PASS: general 

PASS: equipment self-test 

PASS: indicators (list in comments) 

PASS: controls 

PASS: positive indication of proper operation 

Comments: All segments of the display screen are 

illuminated during the self-test. Failure 
is visible if the self-test finds an error. 


FUSES & CIRCUIT BREAKERS: Satisfactory 

PASS: external accessibility 

PASS: easy replacement or reset by operator 

Comments: A fuse is accessible on the battery charger 
only; fuses on the defibrillator/monitor are 
internal. 


LABELS & CODING: Satisfactory 

PASS: placed above controls and displays 

PASS: near or on the items they identify 

PASS: not obscured by other equipment components 

PASS: describe the function of the items they identify 

PASS: readable from normal operating distance 

PASS: conspicuous placards adjacent to hazardous items 

Comments: 


3-20 





SAFETY J 


Satisfactory 


PASS: manual 
PASS: materials 

PASS: fire & explosive protection 

PASS: operator protection from mechanical hazards 
PASS: patient protection from mechanical hazards 
PASS: electrical safety (operator and patient) 

Comments: 


3-21 








3.2.8 Altitude test 


Altitude Test 
Report Form 

Nomenclature: Defibrillator/Monitor 
Manufacturer: Physio Control 
Model number: LIFEPAK* 10 
Serial number: 00004322 
Military item number: None 

Options installed: None 

Date of test: 26 Dec 90 

Item configuration during test: 

Operating on the chamber floor with a simulated ECG 
signal of 60 BPM. 

Performance test criteria: 

Consistent and accurate measurements of simulated ECG 
signals and correct delivery of programmed defibrillator 
energy. 

Ambient conditions outside chamber: 

Temperature 7 5 * F 

Humidity 50% RH 

Barometric pressure 1 atm 


PRETEST DATA 


Pretest performance check: 

Item functional (based on performance test criteria) 

All OK Pass 


Installation of item 
list connections 
list connections 
list connections 
list unconnected 


in test facility: 


to power 
to simulators 
to dummy loads 
terminals 


None 

Valmedix ECG 
None 

Pace and Aux. 
outlets 


3-22 








IN-TEST DATA 


Tine of test start: 14:00 


POSTTEST DATA 

Posttest performance check : 

(complete check of item and accessories) 

Time of test end : 15:00 

Item functional (based on performance test criteria) 

All OK Pass 

Deviation from pretest: None 


Comments on item set-up or checks: 

Comments on test run (including interruptions): 
Comments on other data: 


3-23 







Vibration Test 

Report Form « 

j 

Nomenclature: Defibrillator/Monitor j 

Manufacturer: Physio Control i 

Model number: LIFEPAK* 10 , \ 

Serial number: 00004322 j 

Military item number: None 

* j 

Options installed: None 
Date of test: 26 Dec 90 
Item configuration during test: 

Strapped down on vibration table fixture. 

Performance test criteria: 

Consistent and accurate measurement of simulated ECG 
signals and correct delivery of programmed 
defibrillator energy. 

PRETEST DATA 

Pretest performance check : 

Item functional (based on performance teat criteria) 

All OK Pass 

in test facility: 
to power 
to simulators 


to dummy loads 
terminals 


Ambient conditions 

Temperature 7 0 * F 

Humidity 50% RH 

Barometric pressure 1 atm 


None 

Defibrillator 
Analyzer, Valmedix 
ECG 
None 

Pace and Aux. 
outlets 


Installation of item 
list connections 
list connections 


list connections 
list unconnected 


3-24 






IN-TEST DATA 


Data and performance checks during test: 
Times and dates of test start 


X: 12/26/90, 0910 

Y: 

12/26/90, 1015 

Z: 12/26/90, 1233 

Time at first check: 

X: 0920 

Y: 

1020 

Z: 1242 


Item functional (based on performance test criteria) 

All OK Pass 

Deviation from pretest: None 
Time at second check: 

X: 1002 Y: 1107 Z: 1330 

Item functional (based on performance test criteria) 

All OK Pass 

Deviation from pretest: None 


POSTTEST DATA 
Time at test end: 

X: 1005 Y: 1115 Z: 1333 

Posttest performance check: 

(complete check of item and accessories) 

Item functional (based on performance test criteria) 

All OK Pass 

Item intact: Yes 
Deviation from pretest: None 


Comments 

Comments 

Comments 


on item set-up or checks: 

on test run (including interruptions): 

on other data: 


3-25 




3.2.10 High temperature test 


High Temperature Test 
(equipment operating) 

Report Form 

Nomenclature: Defibrillator/Monitor 
Manufacturer: Physio Control 
Model number: LIFEPAK* 10 
Serial number: 00004322 
Military item number: None 

Options installed: None 

Date of test: 22 Dec 90 

Item configuration during test: 

Operating on wire test stand in the center of the 
chamber. 

Performance test criteria: 

Consistent and accurate measurement of simulated ECG 
signals and correct delivery of programmed 
defibrillator energy. 

Ambient conditions outside chamber: 

Temperature 2 3 * C 

Humidity 54% RH 

Barometric pressure 1 atm 


PRETEST DATA 


Pretest performance check : 

Item functional (based on performance test criteria) 

All OK Pass 


Installation of item in test facility: 
list connections to power 
list connections to simulators 


list connections to dummy loads 
list unconnected terminals 


None 

Defibrillator 
Analyzer, Valmedix 
ECG 
None 

Pace and Aux. 
outlets 


3-26 





distance from north wall (meters) 0.57 
distance from south wall (meters) 0.57 
distance form east wall (meters) 1.22 
distance from west wall (meters) 1.38 
distance from ceiling (meters) 1.50 
distance from floor (meters) 0.50 


Time of test start: 7:55 
Performance checks during test: 
First cneck: 


Time: 8:25 

Temperature: 49*C ± l'C 

Humidity: 15% RH ± 1% RH 

Barometric pressure: 1 atm 

Item functional (based on performance test 

All OK 

Deviation from pretest: None 


Second check: 

Time: 8:55 

Temperature: 49 *C ± 1*C 

Humidity: 15% RH ± 1% RH 

Barometric pressure: 1 atm 

Item functional (based on performance test 

All OK 

Deviation from pretest: None 
Third check: 

Time: 9:25 

Temperature: 49’C ± 1*C 

Humidity: 15% RH ± 1% RH 

Barometric pressure: 1 atm 

Item functional (based on performance test 

All OK 

Deviation from pretest: None 


criteria) 

Pass 


criteria) 

Pass 


criteria) 

Pass 


3-27 


POSTTEST DATA 


Posttest performance check: 

(complete check of item and accessories) 

Time of test end: 9:55 

Item functional: (based on performance test criteria) 

All OK Pass 

Deviation from pretest: None 


Comments on item set-up or checks: 


Comments on test run (including interruptions): 


Comments on other data: 


3-28 



3.2.11 High temperature storage test 


High Temperature Test 
(equipment in storage) 

Report Form 

Nomenclature: Defibrillator/Monitor 
Manufacturer: Physio Control 
Model number: LIFEPAK* 10 
Serial number: 00004322 
Military item number: None 

Options installed: None 

Date of test: 22 Dec 90 

Item configuration during test: 

Sitting on wire test stand in the center of the 
chamber. The unit is in storage, not operating. 

Performance test criteria: 

Consistent and accurate measurement of simulated ECG 
signals and correct delivery of programmed 
defibrillator energy. 

Ambient conditions outside chamber: 

Temperature 23°C 

Humidity 54% RH 

Barometric pressure 1 atm 


PRETEST DATA 

Pretest performance check: 

Item functional (based on performance test criteria) 

All OK Pass 

Installation of item in test facility: 
list connections to power 
list connections to simulators 
list connections to dummy loads 
list unconnected terminals 


None 

None 

None 

All (Pace and 
Aux.) 


3-29 






distance from north wall (meters) 0.57 
distance from south wall (meters) 0.57 
distance form east wall (meters) 1.22 
distance from west wall (meters) 1.38 
distance from ceiling (meters) 1.50 
distance from floor (meters) 0.50 


Time of test start: 10:25 

Midtest time: 13:25 

Midtest temperature: 49*C ± 1*C 
Midtest humidity: 15% RH ± 1% RH 


POSTTEST DATA 

Posttest performance check: 

(complete check of item and accessories) 

Time of test end: 16:25 

Item functional (based on performance test criteria) 

All OK pass 

Deviation from pretest: None 


Comments on item set-up or checks: 


Comments on test run (including interruptions): 


Comments on other data: 


3-30 








3.2.12 Low temperature test 


Low Temperature Test 
(equipment operating) 

Report Form 

Nomenclature: Defibrillator/Monitor 
Manufacturer: Physio Control 

Model number: LIFEPAK® 10 
Serial number: 00004322 
Military item number: None 

Options installed: None 

Date of test: 23 Dec 90 

Item configuration during test: 

Operating on the wire test stand in the center of 
the chamber. 

Performance test criteria: 

Consistent and accurate measurement of simulated ECG 
signals and correct delivery of programmed 
defibrillator energy. 

Ambient conditions outside chamber: 

Temperature 24°C 

Humidity 58% RH 

Barometric pressure 1 atm 

PRETEST DATA 

Pretest performance check: 

Item functional (based on performance test criteria) 

All OK Pass 


None 

Defibrillator 
Analyzer, Valmedix 
ECG 
None 

Pace and Aux. 
outlets 


Installation of item in test facility: 
list connections to power 
list connections to simulators 


list connections to dummy loads 
list unconnected terminals 


3-31 







distance from north wall (meters) 0.57 
distance from south wall (meters) 0.57 
distance form east wall (meters) 1.22 
distance e rom west wall (meters) 1.38 
distance .rom ceiling (meters) 1.50 
distance from floor (meters) 0.50 


Time of test start: 7:55 
Performance checks during test: 

First check: 

Time: 8:25 

Temperature: 0.0*C ± l* C 

Humidity: n/a 

Barometric pressure: 1 atm 

Item functional (based on performance test criteria) 

All OK Pass 

Deviation from pretest: None 
Second check: 

Time: 8:55 

Temperature: 0.0*C ± '."C 

Humidity: n/a 

Barometric pressure: 1 atm 

Item functional (based on performance test criteria) 

All OK Pass 

Deviation from pretest: None 
Third check: 

Time: 9:25 

Temperature: 0.0*C ± 1*C 

Humidity: n/a 

Barometric pressure: 1 atm 

Item functional (based on performance test criteria) 

All OK Pass 

Deviation from pretest: None 


3-32 


m 




POSTTEST DATA 


Posttest performance check: 

(complete check of item and accessories) 

Time of test end: 9:55 

Item functional (based on performance test criteria) 

All OK Pass 

Deviation from pretest: None 


Comments on item set-up or checks: 

Comments on test run (including interruptions): 
Comments on other data: 


3-33 



3.2.13 Low temperature storage test 


Low Temperature Test 
(equipment in storage) 

Report Form 

Nomenclature: Defibrillator/Monitor 

Manufacturer: Physio Control 
Model number: LIFEPAK® 10 
Serial number: 00004322 
Military item number: None 

Options installed: None 

Date of test: 23 Dec 90 

Item configuration during test: 

Sitting on wire test stand in the center of the 
chamber. The unit is in storage, not operating. 

Performance test criteria: 

Consistent and accurate measurement of simulated ECG 
signals and correct delivery of programmed 
defibrillator energy. 

Ambient conditions outside chamber: 

Temperature 2 4 * C 

Humidity 58% RH 

Barometric pressure 1 atm 


PRETEST DATA 


Pretest performance check: 

Item functional (based on performance test criteria) 

All OK Pass 


Installation of item in test facility: 
list connections to power: 
list connections to simulators: 
list connections to dummy loads 
list unconnected terminals 


None 

None 

None 

All (Pace and 
Aux.) 


3-34 






distance 

distance 

distance 

distance 

distance 

distance 


from north wall (meters) 
from south wall (meters) 
form east wall (meters) 
from west wall (meters) 
from ceiling (meters) 
from floor (meters) 


0.57 

0.57 

1.22 

1.38 

1.50 

0.50 


Time of test start: 
Midtest time: 

Midtest temperature: 


10:30 

13:30 

-46'C ± 1*C 


POSTTEST DATA 

Posttest performance check: 

(complete check of item and accessories) 

Time of test end: 15:10 

Item functional (based on performance test criteria) 

All OK Pass 

Deviation from pretest: None 


Comments on item set-up or checks: 


Comments on test run (including interruptions): 


Comments on other data: 

The EUT was allowed to return to ambient conditions 
overnight. 


3-35 








3.2.14 


Humidity Test 
Report Form 


Nomenclature: Defibrillator/Monitor 
Manufacturer: Physio Control 
Model number: LIFEPAK* 10 
Serial number: 00004322 
Military item number: None 

Options installed: None 

Date of test: 24 Dec 90 

Item configuration during test: 

Operating on the wire test stand in the center of 
the chamber. 

Performance test criteria: 

Consistent and accurate measurement of simulated ECG 
signals and correct delivery of programmed 
defibrillator energy. 

Ambient conditions outside chamber: 

Temperature 2 4 * C 

Humidity 40% RH 

Barometric pressure l atm 


4 



PRETEST DATA 

Pretest performance check: 

Item functional (based on performance test criteria) 


All OK 

Installation of item in test facility: 
list connections to power 
list connections to simulators 


list connections to dummy loads 
list unconnected terminals 


Pass 

% 

None 

Defibrillator 

Analyzer, Valroedix 4 

ECG 

None 

Pace and Aux. 
outlets 


3-36 




distance from north wall (meters) 0.57 
distance from south wall (meters) 0.57 
distance form east wall (meters) 1.22 
distance from west wall (meters) 1.38 
distance from ceiling (meters) 1.50 
distance from floor (meters) 0.50 


IN-TEST DATA 

Time of test start: 8:10 
Performance checks during test: 

First check: 

Time: 8:55 

Temperature: 29.5°C ± 1°C 

Humidity: 95% RH ± 1% RH 

Barometric pressure: 1 atm 

Item functional (based on performance test criteria) 

All OK Pass 

Deviation from pretest: None 
Second check: 


Time: 

Temperature: 

Humidity: 

Barometric pressure: 
Item functional (based 


9:40 

29.5°C ± 1*C 
95% RH ± 1% RH 
1 atm 

on performance test criteria) 
All OK Pass 


Deviation from pretest: None 


Third check: 


Time: 

Temperature: 

Humidity: 

Barometric pressure: 
Item functional (based 


10:25 

29.5 ° C ± l'C 
95% RH ± 1% RH 
1 atm 

on performance test criteria) 
All OK Pass 


Deviation from pretest: None 


3-37 


Fourth check: 


Time: 11:10 

Temperature: 29.5'C ± 1*C 

Humidity: 95% RH ± 1% RH 

Barometric pressure: 1 atm 

Item functional (based on performance test criteria) 

All OK Pass 

Deviation from pretest: None 
Fifth check: 

Time: 11:55 

Temperature: 29.5'C ± 1*C 

Humidity: 95% RH ± 1% RH 

Barometric pressure: 1 atm 

Item functional (based on performance test criteria) 

All OK Pass 

Deviation from pretest: None 


POSTTEST DATA 

Posttest performance check: 

(complete check of item and accessories) 

Time of test end: 12:25 

Item functional (based on performance test criteria) 

All OK Pass 

Deviation from pretest: None 


Comments on item set-up or checks: 

Comments on test run (including interruptions): 


Comments on other data: 


3.2.15 Elagtrgnaqnstlg-shflEflStftclafclsfl.fcaat 


***************************************************************** 

Electromagnetic characteristics testing 
evaluation of performance 

********** 4 **************************** 

T & E Item Number: 27 Date: 21 Dec 90 

Nomenclature: Defibrillator/Monitor Manufacturer: Physio Control 
Model number: LIFEPAK* 10 Serial number: 00004322 

Military item number: None 

****************************************************************** 


Conducted emissions ":ests 


CE01 Testing configuration(s): n/a 

Performance (pass/fail): n/a 

Comments: The unit has no external power leads. 

CE02 Testing configuration(s): n/a 

Performance (pass/fail): n/a 

Comments: The unit has no external power leads. 

CE04 Testing configuration(s): n/a 

Performance (pass/fail): n/a 

Comments: The unit has no external power leads. 


i 


V 


Conducted susceptibility tests 

CS02 Testing configuration(s): n/a 

Performance (pass/fail): n/a 

Comments: The unit has no external power leads. 


CS06 Testing configuration(s): n/a 

Performance (pass/fail): n/a 

Comments: The unit has no external power leads. 


3-39 





Radiated emissions tests 


RE02 Testing configuration(s): Operating 

stand in the EMC chamber. 


Performance (pass/fail): 
Comments: 

Fail 

Narrowband failure data 

dB of 

191 kHz - 3.83 MHZ 

3.8 - 

7.46 MHZ - 829.82 MHZ 

1.4 - 

Broadband failure data 

db of 

191 kHz - 3.83 MHZ 

0.9 - 

200 MHZ - 875 MHz 

1.9 - 


Radiated susceptibility tests 

RS03 Testing configuration(s): Operating 

test stand in the EMC chamber. 

Performance (pass/fail): Pass 
Comments: 

The unit was not susceptible to the 
between 200 MHz and 10 GHz. 


on wooden test 


failure 

40.6 

48.1 

failure 

24.5 

39.4 


on the wooden 


test fields 


3-40 



3.3 CRITERIA, SIGNIFICANT PROBLEMS, AND SUGGESTED IMPROVEMENTS 


3.3.1 

Item 

1 

2 

3 

4 

5 


£r-itecia 


Criteria (Source) Remarks 

The physical inventory is con- N/A 
ducted solely for investigation 
and documentation. 


The LIFEPAK® 10 will display a met 

consistent and accurate measure¬ 
ment of simulated ECG signals 
within + 2 percent and deliver 
the programmed defibrillator en¬ 
ergy within 1 percent. 

Verify manufacturer’s specified met 

full power battery life expec¬ 
tancy of 45 minutes during con¬ 
tinuous monitoring of a simu¬ 
lated ECG rate of 60 BPM. 

The LIFEPAK® 10 shall meet the met 
limits established in NAFP 99 
for electrical safety of medical 
equipment. 

The LIFEPAK® 10 must be rated par- 

satisfactory in all major categ- tial- 
ories of the evaluation. These ly met 
include: Visual displays, con¬ 
trols, maintainability, con¬ 
ductors, fasteners, test points, 
test equipment, fuses and cir¬ 
cuit breakers, labels and cod¬ 
ing, and safety. 

The LIFEPAK® 10 will display met 

consistent and accurate measure¬ 
ment of simulated ECG signals 
within ± 2 percent and deliver 
the programmed defibrillator en¬ 
ergy within 1 percent while ex¬ 
posed to an altitude equivalency 
of 15,000 feet above sea level. 


Applicable 
aifeB&EflflcaBli 
2 . 1 . 2.1 

2 . 1 . 2.2 

2 . 2.2 

2.3.2 

2.4.2 


3-41 






7 


2 . 6.2 


While exposed to vibrational net 

stresses, the LIFEPAK® 10 will 
remain operational and be able 
to display a consistent and 
accurate measurement of simu¬ 
lated ECG signals within ± 2 
percent and deliver the pro¬ 
grammed defibrillator energy 
within 1 percent. 

8 During the high temperature met 

operation check, the LIFEPAK® 10 
must display consistent and 
accurate measurement of simu¬ 
lated ECG signals within ± 2 
percent and deliver the pro¬ 
grammed defibrillator energy 
within 1 percent. 

S After the high temperature stor- met 

age cycle, the LIFEPAK® 10 must 
be able to display consistent 
and accurate measurement of sim¬ 
ulated ECG signals within ± 2 
percent deliver the programmed 
defibrillator energy within 1 
percent. 

10 During the low temperature oper- met 

ation check, the LIFEPAK® 10 

must be able to display consis¬ 
tent and accurate measurement of 
simulated ECG signals within ± 2 
percent programmed defibrillator 
energy within 1 percent. 

11 After the low temperature stor- met 

age cycle, the LIFEPAK® 10 must 

be able to display consistent 
and accurate measurement of sim¬ 
ulated ECG signals within ± 2 
percent and deliver the pro¬ 
grammed defibrillator energy 
within 1 percent. 


2.7.2.1 


2.7.2.2 


2 . 8 . 2.1 


2 . 8 . 2.2 


3-42 








2.9.2 


* 


12 While exposed to a high humidity met 
environment, the LIFEPAK® 10 

must display consistent and 
accurate measurement of 
simulated ECG signals within ± 2 
percent and deliver the 
programmed defibrillator energy 
within 1 percent. 

13 The LIFEPAK® 10 shall not pro- par- 

duce emissions in excess of the tially 
limits set forth in MIL-STD-461A met 

Notice 4, paragraph 6.13. 

14 The LIFEPAK® 10 shall not mal- met 

function when it is subjected to 
radiated fields as specified in 
MIL-STD-461A, Notice 4, para¬ 
graph 6.20. 

15 The flight surgeon shall be able par- 

to operate the LIFEPAK® 10 tially 

without physical or functional met 

restrictions aboard the air¬ 
craft. 

16 The LIFEPAK® 10 shall not radi- met 

ate EMI to disrupt or interfere 

with the other equipment or sys¬ 
tems aboard the aircraft. 

17 The aircraft shall not radiate met 

EMI to disrupt or interfere with 

the LIFEPAK® 10. 


2 . 10 . 2.1 


2 . 10 . 2.2 


2 . 11 . 2.1 


2 . 12 . 2.2 


2.12.2.3 


3.3.2 Significant problems which require corrective action 


None 

3.3.3 Suggested improvements 
Suggestion 

1. A method to channel or contain the 
defibrillator cables between the paddles 
needs to be added. This would preclude 
the cables interference when replacing 
the paddles in the LIFEPAK® 10. 


Applicable 

Subparagraph 

2.3.4 and 

2.10.4 


3-43 










3.4 REFERENCES 


3.4.1 Department of Defense. 1971. EMI chara cter istics. 
requirements for equipment . Washington, D.C. M1L-STD-461A, 
Notice 4. February. 

3.4.2 Department of Defense. 1971. EMI characteristics, 
measurement of . Washington, D.C. MIL-STD-462, Notice 3. 
February. 

3.4.3 Department of Defense. 1983. Environmental test methods 
and engineering guidelines . Washington, D.C. MIL-STD-810D. 
July. 

3.1.4 Department of the Army. 1987. Maintenance management 
procedures for medical equipment . Washington, D.C. TB 38-750-2. 
April. 


3.4.5 Department of Defense. 1985. Standard general require¬ 
ments for electronic equipment . Washington, D.C. MIL-STD-454K. 
February. 

3.4.6 Underwriters Laboratory's, Inc. 1978. Standard for 
safety, medical and dental equipment . Chicago, Illinois. 

UL-544. 

3.4.7 Department of Defense. 1989. Human_engineering design 
gni terla . for mili tar y , systems , equip m en t, a n d fagiliti e ft- 
Washington, D.C. MIL-STD-1472D. March. 

3.4.8 Association for the Advancement of Medical Instruments. 
Human factors eng ineering guidelines and preferred practices for 
the design of medical devices . Arlington, Virginia. AAMI-HE- 
1988. February. 

3.4.9 Department of the Army. 1978. Operator's manual. UH-60 
and EH-60 helicopter, with changes 1-5 . Washington, D.C. 

TM 55-1520-237-10. January. 

3.4.10 Department of the Army. 1987. Maintenance management 
procedures for medical earjpment . Washington, D.C. TB 38-750-2. 
April. 

3.4.11 National Fire Protection Association. 1987. Standard 
for health care facilities . Quincy, Massachusetts. February. 


3-44 






3.4.12 Physio Control. 1989. Operating instructions. LIFEPAK* 
10 defibri llator/monitor. Redmond, Washington. 


3.4.13 Mitchell, G. W., and Adams, J. E. 1988. Technical test 
and evaluation of aerone d lcal eq ui p ment. Fort Rucker, AL: U. S. 
Army Aeromedical Research Laboratory. USAARL Letter Report 
LR-88-16-1-2. 




t 




v 


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3.5 ABBREVIATIONS 


AVSCOM 

AEST 

AWR 

BB 

BPM 

CAAF 

CRT 

DC 

ECG 

EMC 

EMI 

fpm 

GFE 

Gpk 

G(rms) 

Hz 

IAW 

ITOP 

IGE 

KHZ 

KIAS 

LCD 

LED 

LIFEPAK® 


MEDEVAC 

MHz 

MIL-STD 

ml 

mm 

mmHg 

MSL 

NAFP 

NB 

NBC 

NiCad 

NVG 


Army Aviation Systems Command 
aeromedical equipment suitability test 
airworthiness release 

broadband 
beats per minute 

Cairns Army Airfield 
cathode ray tube 

direct current 

electrocardiograph 
electromagnetic compatibility 
electromagnetic interference 

feet per minute 

government furnished equipment 

gravity, peak 

gravity (root mean square) 

hertz 

in accordance with 

in-flight test operating procedure 

in-ground effect 

kilohertz 

knots indicated airspeed 

liquid crystal display 
light emitting diode 

10 Physio Control defibrillator/rconitor, 

model LIFEPAK® 10 

medical evacuation 
mega hertz 
military standard 
milliliter 
millimeter 

millimeters of Mercury 
mean sea level 

National Association of Fire Prevention 
narrowband 

nuclear, biological ana chemical 
nickel cadmium 
night vision goggle 


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RAM 

random access memory 

RF 

radio frequency 

RH 

relative humidity 

ROM 

read only memory 

TB 

technical bulletin 

TFT 

technical feasibility testing 

T & E 

test and evaluation 

UES 

Universal Energy Systems, Inc. 

USAARL 

U. S. Army Aeromedical Research Laboratory 

V/m 

volts per meter 


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