PBECISION^MDICM., 

300 Held Drive 

Northampton, PA 16067 USA 

Tel: 610-262-6090 

Fax:610-262-6080 

• '. .'OTifr.r v 

CF -Ml/m: 

L; ' ^' ,.; 

.• - L ^ ^ •3r 

Docket Management Facilit y 

US Department of Transportation 

1200 New Dersey Avenue, SE 

West Building Ground Floor 

Room W12-140 

Washington, DC 20590 

Concerning: FAA-2011-0784-0001 

To whom it may concern, 

Would like to petition the rule making committee to amend the Rule (SFAR 106) to add 

Precision Medical Inc Portable oxygen concentrator to the list of oxygen concentrator 

allowed on aircraft. 

Enclosed are the Letter from the FDA, operator's manual, and the RTCA/DO-160F 

testing results. 

Please respond back to me with any further questions. 

Thank you for your consideration. 

Sincerely, 

fcmPaft40t 

Quality Manager 

Precision Medical Inc. 

300 Held Drive 

Northampton, Pa 18067 

Email:jparker(S)precisionmedical.com 

Phone: 610-262-6090 ext 228 

Fax:610-262-6080 

Cell: 610-762-9673 
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service 

Food and Drug Administration 

10903 New Hampshire Avenue 

Document Control Room -WO66-G609 

Silver Spring, MD 20993-0002 

Precision Medical Inc. 

C/0 Mr. James Parker 

Quality Assurance Manager 

300 Held Drive 

Northhamption, Pennsylvania 18067 JUL - ^ 201^ 

Re: K103563 

Trade/Device Name: Precision Medical Easy Pulse Portable Oxygen Concentrator 

(Model PM4150) 

Regulation Number: 21 CFR 868.5440 

Regulation Name: Portable Oxygen Concentrator 

Regulatory Class: II 

Product Code: CAW 

Dated: June 27, 2011 

Received: June 28, 2011 

Dear Mr. Parker: 

We have reviewed your Section 510(k) premarket notification of intent to market the device 

referenced above and have determined the device is substantially equivalent (for the 

indications for use stated in the enclosure) to legally marketed predicate devices marketed in 

interstate commerce prior to May 28, 1976, the enactment date of the Medical Device 

Amendments, or to devices that have been reclassified in accordance with the provisions of 

the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket 

approval application (PMA). You may, therefore, market the device, subject to the general 

controls provisions of the Act. The general controls provisions of the Act include 

requirements for annual registration, listing of devices, good manufacturing practice, 

labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does 

not evaluate information related to contract liability warranties. We remind you, however, 

that device labeling must be truthful and not misleading. 

If your device is classified (see above) into either class II (Special Controls) or class III 

(PMA), it may be subject to additional controls. Existing major regulations affecting your 

device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In 

addition, FDA may publish further announcements concerning your device in the Federal 

Register. 
Page 2 - Mr. Parker 

Please be advised that FDA's issuance of a substantial equivalence determination does not 

mean that FDA has made a determination that your device complies with other requirements 

of the Act or any Federal statutes and regulations administered by other Federal agencies. 

You must comply with all the Act's requirements, including, but not limited to: registration 

and Usting (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting 

(reporting of medical device-related adverse events) (21 CFR 803); good manufacturing 

practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); 

and if applicable, the electronic product radiation control provisions (Sections 531-542 of 

the Act); 21 CFR 1000-1050. 

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), 

please go to 

http://www.fda.gov/AboutFDA/CentersQfrices/CDRH/CDRHOffices/ucml 15809.htm for 

the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, 

please note the regulation entitled, "Misbranding by reference to premarket notification" 

(21CFR Part 807.97). For questions regarding the reporting of adverse events under the 

MDR regulation (21 CFR Part 803), please go to 

fattp://www.fda.gov/MedicalDevices/Safetv/ReportaProblem/default.htm for the CDRH's 

Office of Surveillance and Biometrics/Division of Postmarket Surveillance. 

You may obtain other general infonnation on your responsibilities under the Act from the 

Division of Small Manufacturers, International and Consumer Assistance at its toll-fi*ee 

number (800) 638-2041 or (301) 796-7100 or at its hitemet address 

http://www.fda.eov/MedicalDevices/ResourcesforYou/Industrv/default.htm. 

Sincerely yours, 

Anthony D. Watson, B.S., M.S., M.B.A. 

Director 

Division of Anesthesiology, General Hospital, 

Infection Control and Dental Devices 

Office of Device Evaluation 

Center for Devices and 

Radiological Health 

Enclosure 
Portable oxygen concentrator 510IC 103563 

510 (k) number (if Iuiown)_Kl 03563 

Device Name: Precision Medical EasyPulse portable oxygen concentrator 

(Model PM4150) 

Indications for use: 

The Precision Medical EasyPulse portable oxygen concentrator (model PM415b) is 

intended to provide supplemental oxygen to persons requiring oxygen therapy. 

The device can be used in a home, institution, vehicle, and for transportable use. 

(Please do not write below this line- continue on another page if needed) 

Concurrence of CDRH, office of device Evaluation (ODE) 

Prescription Use: X Or Over the counter use_ 

(Per21 CFR801.109)/^ , (Optional Format 1-2-9) 

. (Division Sign-OfI) 

Division of Anesthesiology, General Hospital 

Infection Control, Dental Devices 

510(k)Number: m^^L p 
USER MANUAL 

EASYPUlSElPi 

PORTABLE OXYGEN CONCENTRATOR 

Model: PM4150 Series 

ACAUTION 

SAVE THESE INSTRUCTIONS 

Federal (USA) law restricts this device to sale 

by or on the order of a physician. 

PRECISIONfMEDICAL, 

300 Held Drive Tel: (+001) 610-262-6090 

Northampton, PA 18067 USA Fax: (+001) 610-262-6080 

wvvw.precisionmedical.com 
CONTENTS 

RECEIVING/INSPECTION 2 

INTENDED USE 2 

READALL INSTRUCTIONS BEFORE USING 2 

EXPLANATION OF ABBREVIATIONS 2 

SAFETY INFORMATION - WARNINGS AND CAUTIONS 2 

SPECIFICATIONS 4 

COMPONENT DESCRIPTION 5 

OPERATING INSTRUCTIONS 6 

Using the EasyPulse POC 6 

Operating Position 7 

Using the Carry Bag 7 

POWER SUPPLY 9 

ACCESSORIES / REPLACEMENT PARTS 10 

ALARM/INDICATORS/TROUBLESHOOTING 10 

MAINTENANCE/CLEANING 12 

RETURNS 13 

DISPOSAL INSTRUCTIONS 13 

LIMITED WARRANTY 15 

EASrPUlSElPSIXC -

Ponabli Oiyyin Coitctnimef 
RECEIVING / INSPECTION 

Remove the Precision Medical, Inc. EasyPulse Portable Oxygen Concentrator 

(POC) from the packaging and inspect for damage. If there is any damage, DO 

NOT USE and contact your Provider. 

INTENDED USE 

The Precision Medical EasyPulse POC (model PM4150) is intended to provide 

supplemental oxygen to persons requiring oxygen therapy The Precision Medical 

POC can be used in a home, institution, vehicle and for transportable use. 

READALL INSTRUCTIONS BEFORE USING 

This manual is provided for your safety and to prevent damage to the POC. If 

you do not understand this manual, DO NOT USE the POC and contact your 

Provider. 

^DANGER 

This product is not intended as a life-sustaining or life-supporting device. 

EXPLANATION OF ABBREVIATIONS 

mL/min Milliliters Per Minute LED Light Emitting Diode 

POC Portable Oxygen Concentrator 

SAFETY INFORMATION - WARNINGS AND CAUTIONS 

^DANGER 

^WARNING 

•CAUTION 

CAUTION 

us 

OR •a 

Indicates an imminently hazardous situation which, if not avoided, 

will result in death or serious injury. 

Indicates a potentially hazardous situation which, if not avoided, 

could result in death or serious injury. 

Indicates a potentially hazardous situation which, if not avoided, 

may result in minor or moderate injury. 

Used without the safety alert symbol indicates a potentially hazardous 

situation wtiich, if not avoided, may result in property damage. 

PM4150 WITH RESPECT TO ELECTRICAL SHOCK, FIRE 

AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH 

UL60601-1,IEC60601-1,CAN/CSAC22.2 No. 601.1 

Caution! U.S. Federal Law restricts this device to sale by or on 

the order of a physician. 

CONSULT ACCOMPANYING DOCUMENTS 

This device may contain electrical con^ponents that are hazardous to ttie 

environment. DO NOT dispose device into standard trash. Contact your 

local waste Management for disposal of Electronic Equipment. 

Excessive Heat Warning 

I Q I Class II equipment 

/ ^ General Alarm 

Q Power OFF 

S ^ NO SMOKING ® 

IPX1 

DO NOT 

disassemble 

Type BF equipment 

Direct current 

Drip Proof equipment 

NO Oil or Grease 

^ EAsrPuisEiPm: 

PorHblt Oxntn Co/Ktotntor 
• DANGER 

• DO NOT smoke, allow others to smoke or have open flames near the POC 

when in use. 

• DO NOT use near any type of flame or flammable/explosive substances. 

• DO NOT allow POC to exceed "Operating or Storage Temperature Specifications'. 

• Excessive heating of the Carry Bag can occur if Intake vents are blocked. 

• Equipment not suitable for use in the presence of flammable anesthetic. 

TO REDUCE THE RISK OF ELECTRICAL SHOCK: 

• DO NOT use while bathing. 

• DO NOT reach for the POC that has fallen into water. Unplug immediately 

• DO NOT attempt to repair POC. Any attempt could result in electrical shock. 

•WARNING 

• Use the POC for its "Intended Use" as described in this manual. 

• This POC contains magnetic, ferrous material that may affect the results of 

an MRI. 

• In the event of an equipment alamn or if you are experiencing any signs of 

discomfort, connect to another source of oxygen and contact your Provider 

and / or Health Care Professional immediately. 

• In certain circumstances oxygen therapy can be hazardous; any user should 

seek medical advice prior to using this POC. 

• Where the prescribing Health i:are professional has determined that an interruption 

in the supply of oxygen, for any reason, may have serious consequences to the 

user, an alternative source of oxygen should be available for immediate use. 

• ALWAYS keep the POC in an upright position during operation. 

• ALWAYS keep at least 6 in. (15.24 cm) away from walls, furniture, and especially 

curtains that could prevent adequate airflow to the POC. 

• DO NOT place the POC in a small closed space such as a closet. 

• DO NOT use extension cords or electrical adapters. 

• The POC is designed to operate with a single lumen, adult cannula with a 

maximum length of 7 ft (2.1 m). 

• The Setting Knob does not rotate 360". Rotating the knob less than the 

"OFF (6) position" or over "setting 5" will damage the Concentrator. 

• DO NOT use Components / Accessories not recommended by Precision 

Medical, see "ACCESSORIES / REPLACEMENT PARTS". 

TO REDUCE RISK OF BURNS. ELECTROCUTION, FIRE, OR INJURY TO PERSONS: 

• Keep away from heat or open flame. 

• DO NOT use an AC or DC Power Adapter with a damaged power cord or plug. 

• DO NOT use if POC has been dropped or damaged. 

• DO NOT use oil or grease on the POC. 

• DO NOT cover the air vents, the POC requires proper ventilation. 

" DO NOT remove the cover on the POC. Servicing must be performed by a 

trained professional. 

• CAUTION 

The POC is designed to be used indoors or outdoors, in the outdoore 

environment the POC should be used in a "dry location' with Battery only. 

POC is designed to be used in dry conditions, the POC is not to be 

submerged or operated under water. 

Pd/Ub/e Oiyptn ConCfntrMir 3 
CAUTION 

DO NOT place any liquids on or near the POC. If any liquid gets on the POC, 

immediately turn "OFF" the power switch and unplug from the electrical outlet. 

SPECIFICATIONS 

Dimensions: Height: 

Width: 

Depth: 

Weight: 

Shipping Weight: 

Altitude: 

Operating Temperature: 

Storage / Transport Temperature: 

Operating / Storage / Transport 

10.1 in (25.7 cm) 

6.5 in (16.5 cm) 

4.5 in (11.4 cm) 

6.8 lbs (3.08 kg) 

13.1 lbs (5.94 kg) 

Sea level to 9000 ft (2743 m) 

41Tto104T{5°Cto40'C) 

-4T to 140T (-20'C to 60X) 

Relative Humidity: 

Oxygen Concentration: 

Start Up Time 

Oxygen Minute Volume*: 

Up to 95% Non-Condensing 

87% to 95% 

87% OJ Concentration s 10 min 

Setting 1: 240 +/-15% mL/min 

Setting 2: 380 +/-15% mL/min 

Setting 3: 520 +/-15% mL/min 

Setting 4: 660 +/-15% mL/min 

Setting 5: 780 +/-15% mL/min 

Mode of Delivery: 

Trigger Sensitivity: 

Trigger Delay: 

Power: 

Battery Duration: 

(Approximate) 

Sound (@ Setting 2): 

Pulsed Dose 

0.50 cmHjO 

only 

maximum 

0.11 seconds typical 

AC Power Adapter: 

DC Power Adapter: 

Setting 1: 

Setting 2: 

Setting 3: 

Setting 4: 

Setting 5: 

44dBA 

100-240 VAC 

11-16 VDC 

4.5 hrs 

3.2 hrs 

2.5 hrs 

1.8 hrs 

1.5 hrs 

(1.0A@120VAC) 

(5.0 A @ 12 VDC) 

Cannula: Maximum 7 ft (2.1 m) long standard aduH single lumen nasal cannula. 

Equipment Classification: 

Class II - with respect to protection from electrical shock 

Type BF - degree of protection against electrical shock 

IPX1 - degree of protection against ingress of liquids 

Mode of Operation - Continuous 

Volatile Organic Compound (VOC) and Particulate Requirements: 

The oxygen delivered from the EasyPulse POC meets the following requirements for particulate 

levels, VOC levels, carbon monoxide levels, carbon dioxide levels and ozone levels. 

Particulate Matter 

Ozone Levels 

Carbon Monoxide Levels 

Carbon Dioxide Levels 

EPAPMjs 

ASTM D5466 

21 CFR 801.415 

EPA NAAQS - Carbon Monoxide 

OSHA Permissable Exposure Limits 

Standard Test Method for Detennination of Volatile Organic Chemicals in Astmospheres 

(Canister Sampling Methology) 

" At Sea level 

Specrfications a'e subjACt to change without prior notice. 

4 fWM t Ojfjtn Conctnlntor 
COMPONENT DESCRIPTION 

ACAUTION 

Missing or Illegible labels must be replaced, contact Precision Medical, Inc. 

Handle 

Power 

Input Jack 

Setting 

Indicator 

Oxygen Outlet 

Fitting 

Internal Battery 

Level Indicator 

Alarm Indicator 

Inlet Filter 

Product 

Serial # Label '&;^1»S* C ^ 

EASrPlMSElP&lE t 

PortiUs Oiypwi Concomw 
OPERATING INSTRUCTIONS 

•WARNING 

Read this User Manual before operating the POC. 

The POC shall be used by an adult or supervised by an adult when 

being used by a child. 

Additional monitoring or attention may be required for patients using this 

POC who are unable to hear or see alarms or communicate discomfort. 

The Settirtg Knob does not rotate 360^. Rotating the knob less than 

the "OFF (6) position" or over "setting 5" will damage the Concentrator 

•CAUTION 

For Proper Oxygen Flow, be sure that cannula is not kinked or 

obstructed before or during use. 

DO NOT use humidifier bottles with the POC. 

DO NOT use pediatric, low flow nasal cannulas or oxygen masks with 

the POC. 

CAUTION 

Inspect the POC for visual damage before use, DO NOT USE if damaged. 

To prevent damage to the POC, DO NOT operate the POC without 

the inlet filter or while the inlet filter is wet. 

Using the EasyPulse POC 

1. Connect the end of a standard adult single lumen oxygen nasal cannula 

with a maximum length of 7 feet (2.1 m) to the POC's oxygen outlet fitting. 

2. Place the cannula over your ears and 

position the prongs in your nose as 

instructed by your Equipment Provider 

or cannula manufacturer. 

3. Prior to operation, ensure the inlet and exhaust vents on the POC are 

clear. Any blockage of the vents can inhibit performance. 

4. Choose one of the 3 power options: AC Power Adapter, DC Power 

Adapter or Internal Battery {Refer to the "POWER SUPPLY" section of the 

user manual for details on these 3 options). 

5. Turn "ON" the POC by rotating the setting knob clockwise until the 

knob points to your prescribed flow setting number and the number is 

Illuminated green. 

6. Breathe normally through your nose. A measured pulse of oxygen will be 

delivered each time the POC senses an inhalation. To show the POC is 

triggering properly the illuminated setting number will turn off briefly each 

time it senses an inhalation. 

7. To turn "OFF" the POC, rotate the setting knob counterclockwise to the 

"OFF" (6) position. _ ,^ ^ 

6 ParlaNe Qqigin Conctn^hv 
Operating Position 

The POC can be operated in an upright position with or without the 

carry bag as shown below. 

The POC can be operated lying on its back ONLY while in the carry 

bag as shown below. 

Using the Carry Bag 

The carry bag was intended to make the POC easier to transport, 

keep the POC from moving due to vibration and to protect the device 

from minor mishaps. 

CAUTION 

The carry bag was not intended to make the POC waterproof, or 

to protect from major falls or accidents/abuse. 

When inserting the POC into the carry bag make sure of the following: 

• Before placing POC inside bag make sure bag is clean and 

empty. 

• Make sure the control knob and control panel are aligned with 

the clear window on the bag. 

• Make sure bottom exhaust vents are aligned with the mesh 

opening along the bottom of the bag. 

EASyPLOSEimS: i 

Pwtiblt Otjffin Conuntnlof 
Control panel and clear window properly aligned 

Exhaust vents and mesh area properly aligned Proper carrying position 

AWARNING 

The mesh on the carry bag must be aligned with the 

exhaust vents on the POC to keep the POC cool and 

operating properly. 

Be sure the exhaust vents are facing away from body 

while being carried. 

If the outside of the bag feels hot or causes any discomfort, 

set the POC down and check to be sure all vents are 

unobstructed. 

DO NOT cover Air Vents, the POC requires proper 

ventilation. 

DO NOT allow the POC to come in direct contact with 

skin while in the carry bag. 

The carry handle can be placed in either of the positions below with 

the flap secured. 

EASrPUSElPm: 

PortaM Oiypen Conctntnhv 
POWER SUPPLY 

A C Power Adapter: 

The AC power adapter connects the POC to a 100-240 VAC. 50/60 Hz wall outlet. The 

power adapter converts AC voltage to DC voltage in order to power the POC. The AC 

adapter will power the POC and simultaneously charge the internal battery. 

Connecf/o/i; To connect theACPowerAdapter to the POC, insert the DC plug connector 

into the power input jack on the POC and insert the AC wall plug into a wall socket. 

North American Cord (Shown) 

110 Vott/10 Amp ONLY 

DC Plug ^ AG Wall Plug 

DC Power Adapter: 

The DC power adapter connects the POC to an automobile's 12 VDC outlet. The DC 

adapter will power the POC and simultaneously charge the internal battery. 

Connecf/on.'ToconnecttheAC PowerAdapterto the POC, insert the DC plug connector 

into the power input jack on the POC and insert the other end into your automobile's 

12 V accessory jack. 

Auto Accessory Plug 

Internal Battery Pack: 

The POC contains an internal rechargeable lithium ion battery pack. When fully charged, 

the battery will power the POC for up to 4.5 hours dependent upon setting. The Battery 

Level Indicator in the upper right corner of the control panel continuously displays the 

charge level of the internal battery while the POC is on. When the battery charge level 

drops to 15%, the last LED will turn solid red and a brief audible beep will be emitted 

once every minute. When the battery charge level drops to 5% the last LED starts to 

flash red and a brief audible beep is emitted once every 20 seconds to signal that the 

battery is almost depleted and you will need to connect the POC to another power source. 

Charging: The internal battery can be charged by connecting either the AC Power 

Adapter or DC Power Adapter to the POC. The internal battery will begin charging as 

soon as power is connected. You will also be able to run the POC while the internal 

battery charges. 

B^SrPiltSElPSir = 

Pottitle Ojrypin Coflcwrnnv 
ACCESSORIES / REPLACEMENT PARTS 

Precision Medical, Inc. recommends that only the items listed below be used with the POC. 

Description 

Inlet Filter 

AC Power Supply 

DC Power Supply 

Carry Bag 

Cannula 

Part it 

505847 

506629 

506750 

506707 

504833 

Other Power Cord / Plug combination for the AC Power Adapter available thru Precision Medical, Inc. ONLY. 

ALARM / INDICATORS / TROUBLESHOOTING 

The Audible Alarm and LED Indicators are listed in the chart. 

Visual Indicator/ 

Problem 

The last LED on the 

internal Battery Level 

Indicator turns red 

The last LED on 

the internal Battery 

L.evel Indicator 

flashes red 

Amber alarm indicator 

is illuminated and 

setting number is 

not flashing during 

inhalation to signal a 

detected breath 

Red alarm indicator 

Is Illuminated and 

setting number is 

not flashing during 

inhalation to signal 

a detected breath 

Amber alarm 

indicator Is 

illuminated 

Red alarm Indicator 

is illuminated 

Red alarm indicator 

is illuminated, unit 

is not running and 

setting numbers 1 & 

2 are flashing 

Audible Alami 

Repetitive beep 

Repetitive beep 

Repetitive beep 

Repetitive beep 

Repetitive beep 

Repetitive beep 

Repetitive beep 

Probable Cause 

Intemal battery has 

dropped below 15% 

charge remaining 

Intemal battery has 

dropped below^ 5% 

charge remaining 

No breath detected 

for 1 minute 

No breath detected 

for 2 minutes 

Breath rate 

exceeding 35 

breaths / minute 

Breath rate 

exceeding 35 

breaths / minute 

for longer than 

1 minute 

Abnormal 

compressor 

operation detected 

Remedy 

Connect the POC to the AC 

Povrer Adapter, DC Powrer 

Adapter, or external battery pack 

1. Connect the POC to the AC 

Power Adapter, DC Power 

Adapter, or external battery 

pack 

2. Change to alternate oxygen 

source if pov/er source is not 

available 

1. Verify the cannula is not kinked 

2. Veri^ the cannula is properly 

connected to oxygen outlet 

3. Verify the cannula is properly 

positioned in the nose 

1. Verify the cannula is not kinked 

2. Verify the cannula is properly 

connected to oxygen outlet 

3. Verify the cannula is properly 

positioned in the nose 

4. If alami persists change to 

alternate oxygen source and 

contact your Equipment Provider 

Reduce level of activity to a\\o\N 

breath rate to slow 

1. Reduce level of activity to 

allow breath rate to slow 

2. If alarm persists, change to 

alternate oxygen source and 

contact your Equipment Provider 

1.TumthePOCtothe"OFF" 

position 

2. Turn the POC back-ON" to 

prescribed setting 

3. If alami persists, change to 

alternate oxygen source and 

contact your Equipment Provider 

10 

EAsrPLii^ipmr 

fortiM OiyVN CoKentttor 
Visual Indicator/ 

Problem 

Red alarm indicator 

is illuminated, unit 

is not running and 

setting numbers 1 & 

3 are flashing 

Red alarm indicator 

is illuminated, unit 

is not running and 

setting numbers 1 & 

4 are flashing 

Red alarm indicator 

is illuminated, unit 

is not running and 

setting numbers 1 & 

5 are flashing 

Red alami indicator 

is illuminated, unit 

is not running and 

setting numbers 2 & 

3 are flashing 

Red alarm indicator 

is illuminated, unit 

Is not running and 

setting numbers 2 & 

4 are flashing 

Amber alarm 

indicator is flashing 

and unit is running 

Red alarm indicator 

is flashing and unit 

Is running 

Audible Alarm 

Repetitive beep 

Repetitive beep 

Repetitive beep 

Repetitive beep 

Repetitive beep 

NA 

NA 

Probable Cause 

Intemal battery is 

outside its operating 

temperature range 

tOlotor is above it's 

maximum operating 

temperature 

Pressure outside of 

normal operation 

Fan malfunction 

Failed electrical 

connection 

Service Needed 

Service Needed 

Remedy 

1. Turn offthe POC and 

disconnect any power 

supplies 

2. Check that the inlet filter is 

clean 

3. Ensure inlet and exhaust vents 

are not blocked in any way 

4. Verify you are operating the 

POC within the specified 

operating temperature range. 

5. It may be necessary to allow 

the POC to wanri up or cool 

before turning back on 

1. Turn off the POC 

2. Check that the Inlet filter is 

clean 

3. Ensure inlet and exhaust vents 

are not blocked in any way 

4. Verify you are operating the 

POC within the specified 

operating temperature range 

5. It may be necessary to allow 

the POC to cool before 

turning back "ON" 

1. Turn the POC to the "OFF" 

position 

2. Turn the POC back "ON" to 

prescribed setting 

3. If alarm pei^ists, change 

to alternate oxygen source 

and contact your Equipment 

Provider 

1. Turn the POC to the "OFF" 

position 

2. Turn the POC back "ON" to 

prescribed setting 

3. If alarm persists, change 

to alternate oxygen source 

and contact your Equipment 

Provider 

1. Turn the POC to the "OFF" 

position 

2. Turn the POC back "ON" to 

prescribed setting 

3. If alamn persists, change 

to alternate oxygen source 

and contact your Equipment 

Provider 

1. Continue to use POC 

2. Contact Equipment Provider 

1. Switch to another source of 

oxygen 

2. Contact Equipment Provider 

EASyPlMSEpQ£ 5 

PortiMt Oiypn Concwwafor 11 
MAINTENANCE / CLEANING 

AWARNING 

Prior to cleaning, ensure the POC is turned off and unplug any 

external power sources. 

DO NOT disassemble or attempt to repair. There are no user 

serviceable parts inside. Contact your Equipment Provider for service. 

DO NOT spray or apply any cleaners directly onto the case. 

DO NOT allow any liquids to drip inside any case openings^ 

Perform Cleaning as required. 

Cabinet: 

1. The patient should connect to an alternate Oxygen source. 

2. Turn the POC to the "OFF" (6) position. 

3. Unplug the external power source before cleaning. 

4. Clean exterior surfaces of the POC with a cloth dampened with 

disinfectant solution. Example: Sporicidin® Brand Disinfectant Solution. 

5. Allow POC to air dry. 

6. DO NOT place inside carry bag or run the POC until it is thoroughly dry. 

7. When not in use, store the POC in a clean area free from grease, oil and 

other sources of contamination. 

Inlet Filter: 

1. Remove the inlet filter by pulling on the protruding tab. 

2. Wash filter with mild detergent. Rinse thoroughly with water and allow to 

dry completely. 

3. Once filter is dry, push the filter back into the case so only the small tab is 

protruding. 

Inlet Filter 

Tab 

B^syptiSEipm: 

1 2 fWMbh Oxygtn CoiKtntrttor 
RETURNS 

Returned products require a Returned Goods Authorization 

(RGA) number, contact F=*recision Medical, Inc. All returns must 

be packaged in sealed containers to prevent damage. Precision 

Medical, Inc. will not be responsible for goods damaged in 

transit. Refer to Precision Medical, Inc. Return Policy available 

on the Internet, www.precisionmedical.com. 

Manuals available on our website; www.precisionmedical.com. 

DISPOSAL INSTRUCTIONS 

This device may contain electrical components that are hazardous 

to the environment. DO NOT dispose device into standard trash. 

Contact your local waste Management for disposal of Electronic 

Equipment. 

PcvtaWe Oxyyen Coocwifrifor 1 3 
LIMITED WARRANTY 

AND 

LIMITATION OF LIABILITY 

Precision Medical, Inc. warrants that the Portable Oxygen Concentrator 

POC, {the Product), will be free of defects in workmanship and/or 

material for the following period: 

Portable Oxygen Concentrator three (3) years from date of shipment 

Battery 90 days from date of shipment 

Precision l^edical. Inc. is NOT responsible for normal wear and tear, orany 

neglect or abuse of the product. 

Precision Medical, Inc. is NOT responsible for the shipping cost of the repair 

Should any failure to conform to this warranty appear within the 

applicable period, Precision Medical, Inc. shall, upon written notification 

thereof and substantiation that the goods have been stored, installed, 

maintained and operated in accordance with Precision Medical, Inc.'s 

instructions and standard industry practice, and that no modifications, 

substitutions, or alterations have been made to the goods, correct 

such defect by suitable repair or replacement at its own expense. 

ORAL STATEMENTS DO NOT CONSTITUTE WARRANTIES. 

The representatives of Precision Medical, Inc. or any retailers are not 

authorized to make oral warranties about the merchandise described 

in this contract, and any such statements shall not be relied upon 

and are not part of the contract for sale. Thus, this writing is a final, 

complete and exclusive statement of the terms of that contract. 

THIS WARRANTY IS EXCLUSIVE AND IS IN LIEU OF ANY 

WARRANTY OF MERCHANTABILITY, FITNESS FOR A PARTICULAR 

PURPOSE OR OTHER WARRANTY OF QUALITY, WHETHER 

EXPRESS OR IMPLIED. 

Precision Medical, Inc. shall not under any circumstances be liable for 

special, incidental or consequential damages including but not limited 

to lost profits, lost sales, or injury to person or property. Correction 

of non-conformities as provided above shall constitute fulfillment of 

all liabilities of Precision Medical, Inc. whether based on contract, 

negligence, strict tort or otherwise. Precision Medical, Inc. reserves 

the right to discontinue manufacture of any product or change product 

materials, designs, or specifications without notice. 

Precision Medical, Inc. reserves the right to correct clerical or 

typographical errors without penalty. 

14 PoflMbh Qxfgin Conanlntot 
DECLARATION OF CONFORMITY 

Manufacturer: Precision Medical, Inc. 

300 Held Drive. Northampton, PA 18067, 

USA CONTACT Quality Manager 

Phone:610-262-6090 

Authorized European Representative: Emerge Europe (European Office) 

Molenstraat 15 

2513 BH, The Hague 

The Netherlands 

Phone: +31 (0) 70.345.8570 

Fax: -1-31 (0) 70.346.7299 

Product: Portable Concentrator 

Model(s): PM4150 

MDD Class: lib 

Classification criteria: Clause 3.2 Rule 11 of Annex IX of MDD 

As delivered, the object of the declaration described above is in conformity with 

the requirements of MDD 93/42/EEC Annex 11.3 of 14 June 1993, and Directive 

2007/47/EC of The European Parliment and the following documents: 

BS EN 60601 -1, BS EN 60601 -1 -2, BS EN 60601 -1 -8, EN 980, EN 1041, 

lEC 60601-1-4, lEC 60601-1-6. ISO 3744. IEC62366. ISO 3744, ISO 8359, 

ISO 14971, ISO 15001, ISO 15223-1 

Notified Body for Product Safety: 

TUV Rheinland Products Safety GmbH C€oi97 

Certification Registration No's: HD 60019110 0001 

Date of Expiry: 03/08/2012 

PEECISION^'MEDICAL. 

ISO 13485 Certified 

Precision Medical, Inc. 

300 Held Drive 

Northampton, PA 18067 USA 

(-hOOl) 610-262-6090 

[-1-001)610-262-6080 

vifww.precisionmedical.com 

C€ 

0197 506640 RevO 06/28/11 PRINTED IN USA 
ReM Testing Laboratories 

3131 Detwilwr Road, Harleysvllle, PA 19438 

215-256^133 - Fax: 215-256-4130 

CORPORATE OFFICE 

rss IMiwcail Avtn a 

RoHuvikaniB, NY 117TB 

431-737-1500 F u ai-T37-14?7 

(A NT CupBitWii) 

BnAP4CH LABORATORIEB 

101 (tow Baton RO M 

QelWowfi. NH<ao49 

v»4n-WB Fixaoj^r^ni 

WASHMSTON 

REGULATOHV OFFICE 

703-533-1GM Fax TD3-933-1S1E 

MEMBE R 

EMl/RFI Test Report 

For 

Portable Oxygen Concentrator (POC) 

Model Number PM4150 

Customer Name: 

Customer P.O.: 

Date of Report: 

Test Report No.: 

Test Start Date: 

Test Finish Date: 

Test Technicians: 

Precision Medical 

1812088 

Febnjary 11, 2011 

R-1608P 

January 13, 2011 

January 31, 2011 

R. Wilson, F. Civiello 

Approved By: R. J. Reitz 

Report Prepared By: J. Bailey, C. Reitz 

Government Source Inspection: Not Applicable 

Our lettsra, procedures and reports are for the exchisive use of the cuitomer to wtiom they are addmaed and their commuracabon or 

the use of the name of RetH Tettina Laboratories must receive our prior written approval. Our letters, procedures and reports apply only 

to the sample tested and are not necessarily Indicathw of ttie quaHtJes of apparently klentlcal or similar products. Ttie letten, pro»dures, 

reports and the nsme of Retlif Testing Laboratortes or insignia are not to be used under any circumstances in advertising to the piiMc. 

Thb report shall not be reproduced, except in fuD, without prior written approval of Retlif Testkig Laboratories. 

A New York State Corporation 

http://www. retlif.com 
Table of Contents 

List of Tables 4 

List of Figures 4 

Certification and Signatures 5 

Test Program Summary 6 

Revision History 8 

1.0 Scope 9 

2.0 Applicable Documents 9 

3.0 Acronyms and Definitions 10 

4.0 General Requirements 11 

4.1 Test Environment 11 

4.1.1 Shielded Enclosures 11 

4.1.2 RF Absorber Material 11 

4.1.3 Ground Plane 12 

4.2 Test Instrumentation 12 

4.2.1 Grounding 12 

4.2.2 Measurement Accuracy 12 

4.2.3 Detector Function 13 

4.3 Emissions Testing 13 

4.3.1 Ambient Interference Levels 13 

4.3.2 Emission Identification 13 

4.3.3 Bandwidths 13 

4.3.4 Frequency Scanning 13 

4.3.5 Emission Data Presentation 14 

4.3.6 Software- Emissions 14 

4.3.6.1Svk^ept (Analog) Scans 14 

4.4 Calibration of Measuring Equipment 14 

4.4.1 Measurement System Verification 14 

4.4.2 Antenna Factors 14 

4.5 Determination of Antenna Positioning 15 

5.0 Description of Equipment Under Test 17 

5.1 EUT Description 17 

5.1.1 EUT Configuration: 17 

5.1.2 Designations 17 

5.1.3 Physical Characteristics 17 

5.2 Intended Installation 18 

5.3 Electrical Characteristics 18 

5.3.1 Power Input 18 

5.3.2 Grounding 18 

5.3.3 Bonding 18 

5.4 Modifications 18 

5.4.1 Emission of Radio Frequency Energy- Radiated 18 

Retlif Testin g Laboratorie s 

Report No. R-1608P 

Page 2 of 95 
5.5 

6.0 

6.1 

Mode of Operation 18 

5.5.1 Support Equipment 19 

5.5.2 Monitoring Equipment 19 

Test Sequence and Results 21 

RTCA/DO-160F, Section 21, RF Radiated Emissions, Category M, 

100 MHz to 6 GHz 22 

6.1.1 Purpose 22 

6.1.2 Test Description 22 

6.1.3 Test Setup 23 

6.1.4 Test Equipment 25 

6.1.5 Test Procedure 26 

6.1.6 Test Results 27 

Test Photographs 28 

Test Data 44 

Transducer Factors 92 

Retlif Testing Laboratories 

Report No. R-1608P 

Page 3 of 95 
List of Tables 

Table 1 - Test Methods and Results 7 

Table 2 - RF Absorber Material 11 

Table 3 - Bandwidths and Measurement Times 13 

Table 4 - EUT Designations 17 

Table 5 - Physical Characteristics 17 

Table 6-Power Input 18 

Table 7 - Test Sequence and Results 21 

Table 8 - Radiated RF Emissions, Test Antennas 23 

List of Figures 

Figure 1 -Antenna Positioning 16 

Figure 2 - General Test Setup, Configuration 1 20 

Figure 3 - General Test Setup, Configuration 2 20 

Figure 4 - Radiated RF Emissions, Category M Test Limit 22 

Figure 5 - Antenna Positions Setup 23 

Figure 6 - Radiated RF Emissions, 100 MHz to 6 GHz, Test Setup 24 

Retlif Testing Laboratories 

Report No. R-1608P 

Page 4 of 95 
Certification and Signatures 

We certify that this report is a true representation of the results obtained from the tests of 

the equipment stated and related only to the equipment tested. We further certify that the 

measurements shown in this report were made in accordance with the procedures 

indicated and vouch for the qualifications of all Retlif Testing Laboratories personnel taking 

them. 

^^i-y^/^4 ^ 

Daniel Mis 

EMC Test Engineer 

Richard J. Reitz 

Corporate Laboratory Manager 

INARTE Certified Engineer ATL-0036-E 

NVLAP Approved Signatory 

Non-Warranty Provlalon 

Th« testing services have been performed, findings obtained and reports prepared In acconlance with generally accepted laboratory 

priiiciples and practices. This warranty is in lieu of all others, either expressed or implied. 

Non-Endoraement 

This teat report contains only findings and results arrived at after employing the specific test procedures and standards listed herein It is 

not intendad to constitute a recommendation, endorsement or certification of the product or material tested. This test report may not be 

used by the dient to clatm product endorsement by NVLAP, NIST or any agency of the U.S. Government. 

n Retlif Testing Laboratories 

Report No. R-1608P 

Page 5 of 95 
Test Program Summary 

Report Number: R-1608P 

Customer: Precision Medical 

Address: 300 Held Drive 

Northampton. PA 18067 

Test Sample: Portable Oxygen Concentrator (POC) 

IModei Number: PM4150 

Serial Number: TSU1730 

{Manufactured By: Precision Medical 

Test Specification: 

RTCA/DO-160F Environmental Conditions and Test Procedures for Airborne Equipment 

EUT Configuration: 

During the performance of all testing specified herein, the Portable Oxygen Concentrator 

was tested in the following configurations: 

Configuration 1: 

• The Portable Oxygen Concentrator was using an External Battery providing 18 VDC 

Configuration 2: 

• The Portable Oxygen Concentrator was using an Internal Battery providing 18 VDC 

IMode of Operation: 

During the performance of all testing specified herein, the Portable Oxygen Concentrator 

(POC) was operated as detailed below; 

• The Oxygen Minute Volume was set at 5: 760 ± 15% cc/min 

e Battery LED indicators (4) were Green 

a Alarm indicator was in the OFF state 

The following software was running during the course of all testing specified herein: 

• 1.A2 

Page 6 of 95 

Retlif Testing Laboratories 

Report No. R-1608P 
Test {Methods: 

The test methods performed on the Portable Oxygen Concentrator (POC) and the 

corresponding test results are shown in Table 1. 

Table 1 - Test Methods and Results 

RTCA/DOleOFPara. 

21 

Para. 

Herein 

6.1 

Method 

Emission of Radio Frequency Energy -

Radiated, Category M 

Configuration 

1 

2 

Test Results 

Complied'^^ 

Complied'^* 

^^' Emission of Radio Frequency Energy - Radiated, Configuration 1 

January 13, 2011 

The EUT produced a single discrete emission above the specified limit at 151.303 MHz 

with the antenna in the vertical polarization. This emission was 37.99 dBuV/m, 0.52dB 

above the limit of 37.49 dBuV/m. 

January 31, 2011 

After the modification detailed in Paragraph 5.4.1 was performed the EUT was retested and 

found to comply with the specified requirements of RTCA/DO-160F, Section 21, Radiated 

RF Emissions. 

'^^ Emission of Radio Frequency Energy - Radiated, Configuration 2 

January 13, 2011 

The EUT produced a single discrete emission above the specified limit at 150.301 MHz 

with the antenna in the vertical polarization. This emission was 38.36 dBuV/m, 0.94 dB 

above the limit of 37.42 dBuV/m. 

January 31, 2011 

After the modification detailed in Paragraph 5.4.1 was performed the EUT was retested and 

found to comply with the specified requirements of RTCA/DO-160F, Section 21, Radiated 

RF Emissions. 

NVLAP Lab Code 200815-0 

All test methods listed above are included in Harleysville, Pennsylvania NVLAP Scope of 

Accreditation and were performed in accordance with the Retlif Testing Laboratory Quality 

System which is compliant with the requirements of ISO/IEC 17025 General Requirements 

for the Competence of Calibration and Testing Laboratories. 

Page 7 of 95 

Retlif Testing Laboratories 

Report No. R-1608P 
Revision History 

Revisions to this document are listed below; the latest revised document supersedes all 

previous issues of this document: 

Revision Date 

February 11,2011 

Pages Affected 

Original Release 

Retlif Testing Laboratories 

Report No. R-1608P 

Page 8 of 95 
1.0 Scope 

The purpose of this test program was to determine the compliance of the Portable 

Oxygen Concentrator (POC), Model Number: PM4150, Serial Number: TSU1730, 

manufactured by Precision Medical of Northampton, PA 18067, to the requirements 

of RTCA/DO-160F. The test methods performed on each unit are outlined in 

Paragraph of this test report. 

2.0 Applicable Documents 

The following documents form a part of this test report to the extent specified herein: 

Retlif Testing Laboratories, RCM-001; Rev. H, Calibration Manual 

Retlif Testing Laboratories, RQM-001; Rev. O, Quality Assurance Manual 

ANSI/NCSL Z540.1; 94 (R2002), Calibration Laboratories and Measuring and Test 

Equipment General Requirements 

ISO/IEC 17025: 2005, General Requirements for the Competence of Testing and 

Calibration Laboratories 

MIL-PRF-15733H, Filters, Radio Frequency Interference, General Specifications for 

MIL-STD-220B, Insertion Loss Measurement, Method of 

IEEE-Std-299; 09/15/06, Attenuation Measurements for Enclosures, 

Electromagnetic Shielding for Electronic Test Purposes 

RTCA/DO-160F, Environmental Conditions and Test Procedures for Airborne 

Equipment 

Retlif Testin g Laboratorie s 

Report No. R-1608P 

Page 9 of 95 
3.0 Acronyms and Definitions 

The following acronyms may be used within this test report: 

BIT: 

BCI: 

CE: 

CS: 

dB: 

dBpT: 

dBpA: 

dBfjV: 

dSpV/m: 

EMC: 

EME: 

EMI: 

EMICP: 

EMITP: 

EMITR: 

ERP: 

EUT: 

GFE: 

GHz: 

GSI: 

Hz: 

ISM: 

kHz: 

LISN; 

mA: 

mS: 

mQ: 

MHz: 

POC: 

RE: 

RF: 

RS: 

RMS: 

TEM: 

TPD: 

pA: 

MF: 

pH: 

pV: 

|jV/m: 

V/m: 

Q: 

Built-in Test 

Bull< Cable Injection 

Conducted Emissions 

Conducted Susceptibility 

Decibel 

Decibels Relative to One Picotesia 

Decibels Relative to One Microampere 

Decibels Relative to One Microvolt 

Decibels Relative to One Microvolt per Meter 

Electromagnetic Compatibility 

Electromagnetic Environment 

Electromagnetic Interference 

Electromagnetic Interference Control Procedures 

Electromagnetic Interference Test Procedures 

Electromagnetic Interference Test Report 

Effective Radiated Power 

Equipment Under Test 

Government Furnished Equipment 

Gigahertz 

Government Source Inspection 

Hertz 

Industrial, Scientific and Medical 

Kilohertz 

Line Impedance Stabilization Network 

Milliampere 

Millisecond 

Milliohm 

Megahertz 

Portable Oxygen Concentrator 

Radiated Emissions 

Radio Frequency 

Radiated Susceptibility 

Root Mean Square 

Transverse Electromagnetic 

Terminal Protection Device 

Microampere 

Microfarad 

Microhenry 

Microvolt 

Microvolts per Meter 

Volts per Meter 

Ohm 

Page 10 of 95 

Retlif Testing Laboratories 

Report No. R-1608P 
4.0 General Requirements 

4.1 Test Environment 

All testing was performed at the Retlif Testing Laboratories, Harleysville, 

Pennsylvania facility. Each test method was performed in the environment specified 

within RTCA/DO-160F. Where the test environment deviated from that specified, it 

is noted in the applicable test method. 

4.1.1 Shielded Enclosures 

Alt testing which required the use of a shielded enclosure was performed in a 

solid steel, double wall, modular type enclosure. The attenuation characteristics 

of the enclosure were in accordance with IEEE-Std-299. All input power lines to 

the enclosure were filtered utilizing filters manufactured in accordance with MILPRF-15733H and tested in accordance with MIL-STD-220B. 

4.1.2 RF Absorber Material 

Test methods requiring anechoic treatment, Radiated RF Emissions, was 

performed in a room treated with a combination of pyramidal carbon impregnated 

foam absorber, flat carbon impregnated foam absorber and ferrite tile. The RF 

absorber was placed above, behind and on both sides of the EUT, as well as 

behind the radiating or receiving antenna. Minimum performance of the material 

is as specified in Table 2. 

Table 2 - RF Absorber Material 

Frequency 

100 MHz to 250 MHz 

Above 250 MHz 

Minimum Absorption 

6.0 dB 

10.0 dB 

Retlif Testin g Laboratorie s 

Report No. R-1608P 

Page 11 of 95 
4.0 General Requirements (con't.) 

4.1.3 Ground Plane 

The ground planes were 0.032 or thicker, % hard brass measuring 2.25 m^ or 

larger in area with the smaller side no less than 76.0 cm. The ground plane had 

a surface resistance no greater than 0.1 mO per square meter. The DC 

resistance between the ground plane and the shielded enclosure was 2.5 mQ or 

less. The metallic ground plane was electrically bonded to the wall of the basic 

shielded room structure at least once every meter. The metallic bond straps 

were solid and maintained a five-to-one ratio or less in length to width. 

4.2 Test Instrumentation 

A listing of all test instrumentation utilized is contained within each applicable test 

method. These listings indicate the model, manufacturer, and frequency range of all 

instrumentation utilized. All instrumentation utilized was calibrated prior to use in 

accordance with the procedures set forth in Retlif Testing Laboratories standard 

manuals RCM-001 and RQM-001, which are in accordance with the requirements of 

ANSI/NCSL Z-540-1. 

4.2.1 Grounding 

Interference measuring instruments were physically grounded with only one 

connection, where possible. When an antenna was used, the measuring 

instrument was connected to ground with only the power cord ground (green 

wire). When a copper bonding strap was used on the measuring instrument or 

the antenna (such as the rod counterpoise), neither the power cord ground or the 

instrument ground terminals were used. When the measurement system was 

grounded by other means, care was taken to ensure the validity of the test 

results. 

4.2.2 Measurement Accuracy 

The accuracy of all measurements is as follows: 

• Frequency: ±2% 

• Amplitude, measurement receiver: ±2 dB 

• Amplitude, measurement system: ±3 dB 

• Distance: ±5% 

• Time (waveforms): ±5% 

Retlif Testin g Laboratorie s 

Report No. R-1608P 

Page 12 of 95 
4.0 General Requirements (con't.) 

4.2.3 Detector Function 

A peak detector was used for all frequency domain emissions and susceptibility 

measurements. This device detects the peak value of the modulation envelope 

in the receiver band pass. Measurement receivers were calibrated in terms of an 

equivalent RMS value of a sine wave that produces the same peak value. When 

other measurement devices such as oscilloscopes, non-selective voltmeters, or 

broadband field strength sensors are used for susceptibility testing, correction 

factors were applied to test signals to convert the reading to the equivalent RMS 

values under the peak of the modulation envelope. 

4.3 Emissions Testing 

4.3.1 Ambient Interference Levels 

Ambient interference levels within the shielded enclosures for radiated emissions 

were measured prior to EMI tests with the EUT de-energized and were at least 6 

dB below the allowable specification limits. 

4.3.2 Emission Identification 

All emissions, regardless of characteristics, were measured with the 

measurement receiver bandwidths, as specified in Table 3, and compared 

against the limits shown herein. Identification of emissions with regard to 

narrowband or broadband characterization is not applicable. 

4.3.3 Bandwidths 

Interference was measured utilizing the peak detector function of the interference 

measuring equipment set to the IF bandwidths (BWI) shown in Table 3. 

4.3.4 Frequency Scanning 

For emission measurements, the entire frequency range for each applicable test 

was scanned. These frequencies included the critical frequencies of the EUT, 

provided they fell within the frequency range of test. 

Table 3 - Bandwidths and Measurement Times 

Frequency Band 

100 MHz to 400 MHz 

400 MHz to 1 GHz 

1 GHz to 6 GHz 

6 dB Bandwidtli 

BW) 

10 kHz 

100 MHz 

1 MHz 

{Minimum Measurement Time for 

Analog {Measurement Receivers 

1.5 sec/MHz 

0.15 sec/MHz 

15 sec/GHz 

Retlif Testin g Laboratorie s 

Report No. R-1608P 

Page 13 of 95 
4.0 General Requirements (con't.) 

4.3.5 Emission Data Presentation 

Amplitude versus frequency profiles of emissions data were automatically 

generated and displayed at the time of test and were continuous. The displayed 

information accounted for all applicable correction factors and included the 

applicable limit. The plotted data provides a minimum frequency resolution of 

1% or twice the measurement receiver bandwidth, whichever was less stringent 

and minimum amplitude resolution of 1.0 dB. 

4.3.6 Software - Emissions 

4.3.6.1 Swept (Analog) Scans 

EMI Measurement Software ES-K1 Version 1-6 SP1, manufactured by Rohde and 

Schwarz of Munich, Germany was utilized for the following tests: 

• Emission of Radio Frequency - Radiated 

This software directs the Rohde & Schwarz EMI Receiver sweep start and stop 

frequencies, scan rate, bandwidths and detector functions. The software 

integrates antenna factors, cable losses, and amplifier factors (when applicable), 

and presents the resultant measurements in graphical format and includes the 

specified test limits. Software is validated prior to test means of pretest 

measurement system verifications. 

4.4 Calibration of Measuring Equipment 

Test equipment and accessories required for measurement in accordance with 

RTCA/DO-160F were calibrated in accordance with ANSI/NCSL Z540.1, ISO 10012-

1 or under an approved calibration program traceable to the National Institute for 

Standards and Technology. In particular, measurement antennas, current probes, 

field sensors, and other devices used in the measurement loop are calibrated at 

least every year. 

4.4.1 Measurement System Verification 

At the start of each emission test, the complete test system (including 

measurement receivers, cables, attenuators, couplers) was verified by injecting a 

knovt/n signal, as stated in the individual test procedure. 

4.4.2 Antenna Factors 

Factors for test antennas were determined in accordance with SAE ARP958. 

Page 14 of 95 

Retlif Testin g Laboratorie s 

Report No. R-1608P 
4.0 General Requirements (con't.) 

4.5 Determination of Antenna Positioning 

The number of required antenna positions depended on the size of the test setup 

boundary and the number of enclosures included in the setup. The test setup 

boundary is defined to include the EUT enclosure(s) and 1.0 meters of exposed 

interconnecting cable (except for leads that are shorter in actual installation) and the 

1.0 meters of exposed power leads positioned 10 cm from and parallel to the front 

edge of the test bench. The actual test boundary size is documented in the test 

results in Section 6 of this test report. 

The physical reference points of the antennas shown in Figure 1 were used for 

measuring the heights of the antennas and distances of the antenna from the test 

boundary. The antennas were placed 1.0 meter from the front edge of the EUT, and 

positioned laterally as shown in Figure 1 The Biconical and Horn antennas were 

centered 0.3 meters above the ground plane and parallel to the ground plane as 

shown in Figure 1. Antennas were placed at least 0.3 meters from the shielded 

enclosure wall or absorber. For radiated emissions, the 41 inch active Rod was 

positioned at the same height as the ground plane. 

Retlif Testing Laboratories 

Report No. R-1608P 

Page 15 of 95 
Figure 1 - Antenna Positioning 

n 

Field 

Caiitvation 

Polni 

TransmIrT[_ 

1 meior AntenngJJ" 

End of txptxed CaUe. 

Unetiieldad cable may be shielded from 

here 10 wall. 

E-Field 

Monitor 

Power Amplrfior 

Signal Gansrator 

Retlif Testing Laboratories 

Report No. R-1608P 

Page 16 of 95 
5.0 Description of Equipment Under Test 

5.1 EUT Description 

The Portable Oxygen Concentrator (POC) is intended to provide supplemental 

oxygen to persons requiring oxygen therapy. The POC is not intended to be life 

supporting or life sustaining. The POC is intended for use in the home or hospital 

institutional environment or while ambulatory. 

5.1.1 EUT Configuration: 

During the performance of all testing specified herein, the EUT was configured 

as shown in Figure 2 - General Test Setup, Configuration 1 and Figure 3 -

General Test Setup, Configuration 2. The EUT was tested in the following 

configurations: 

Configuration 1: 

• The Portable Oxygen Concentrator was using an External Battery 

providing 18 VDC 

Configuration 2: 

• The Portable Oxygen Concentrator was using an Internal Battery 

providing 18 VDC 

5.1.2 Designations 

Table 4 details the equipment nomenclature, Part Number, Model Number and 

Serial Number, where applicable, of all EUT system components. 

Table 4 - EUT Designations 

System Component Manufacturer 

Model / Part 

Number 

Serial 

Number 

Configuration 1 

Portable Oxygen Concentrator (POC) Precision Medical, Inc PM4150 TSU1730 

External Battery Pack Cell-Con 506760 N/A 

Configuration 2 

Portable Oxygen Concentrator (POC) 

with Internal Battery 

Precision Medical, Inc. PM4150 TSU1730 

5.1.3 Physical Characteristics 

Table 5 details the physical characteristics of all EUT components. 

Table 5 

System Component 

Portable Oxygen Concentrator (POC) 

External Battery Pack 

- Physical Characteristics 

Depth (cm) 

11.3 

17.0 

Width (cm) 

16.5 

8.0 

Height cm) 

25.4 

3.0 

Weight kg) 

3.0 

0.59 

Page 17 of 95 

Retlif Testing Laboratories 

Report No. R-1608P 
5.2 Intended Installation 

The EUT is intended is a portable device. 

5.3 Electrical Characteristics 

5.3.1 Power Input 

Table 6 details the electrical power requirements of all EUT components for 

Configuration 1 and Configuration 2. 

Table 6 - Power Inpu 

System Component Input Voltage Frequency Current 

Portable Oxygen Concentrator (POC) 18V DC 1.0 Amp 

5.3.2 Grounding 

The EUT contained no external wire grounds. 

5.3.3 Bonding 

No bonding was performed on the EUT during testing. 

5.4 Modifications 

The following modifications were made to the EUT during the course of this testing 

program in order to demonstrate compliance: 

5.4.1 Emission of Radio Frequency Energy - Radiated 

Configuration 1 and 2 

January 31, 2011 

• Added a Toroid, Manufacturer: Lorid, Part Number: 28B0375-400, to the 

Equalization value leads. The Toroid was placed at the top of the EUT 

near the control PCB. 

5.5 Mode of Operation 

During the performance of all testing specified herein, the Portable Oxygen 

Concentrator (POC) was operated as detailed below: 

• The Oxygen Minute Volume was set at 5: 760 ± 15% cc/min 

• Battery LED indicators (4) were Green 

• Alarm indicator was in the OFF state 

The following software was running during the course of all testing specified herein: 

• 1.A2 

Page 18 of 95 

Retlif Testing Laboratories 

Report No. R-1608P 
5.5.1 Support Equipment 

No additional equipment was utilized to achieve the EUT operating state 

specified in Paragraph 5.5. 

5.5.2 Monitoring Equipment 

The EUT was visually monitored for indications of degradation or malfunction 

(susceptibility) as detailed in Paragraph 5.6. No additional equipment utilized to 

monitor the EUT for indications of degradation or malfunction (susceptibility) as 

detailed in Paragraph 5.6. 

Page 19 of 95 

Retlif Testing Laboratories 

Report No. R-1608P 
Figure 2 - General Test Setup, Configuration 1 

Ground Plane 

EUT 

"T> 

EUT placed lOorTlrom 

edge of plane 

Figure 3 - General Test Setup, Configuration 2 

Ground Plane 

O 

EUT 

y 

EUT placed 10cm from 

edge of plane 

Page 20 of 95 

Retlif Testing Laboratories 

Report No. R-1608P 
6.0 Test Sequence and Results 

The following test methods were performed on the Portable Oxygen Concentrator (POC), 

Model Number: PM4150, Serial Number: TSU1730, to the requirements of RTCA/DO-160F 

as specified by Precision Medical, Environmental Conditions and Test Procedures for 

Airborne Equipment, RTCA DO-160F, December 6, 2007. All testing documented herein 

was performed in the sequence shown in Table 7. 

Testing Date Para. 

Herein 

Table 7 - Test Sequence and Results 

Method Configuration Test Results 

January 13, 2011 6.1 Section 21, Emission of Radio 

Frequency Energy - Radiated 

1 Did Not Comply 

Did Not Comply 

January 31, 2011 See Paragraph 5.4.1 for a detailed description of the modification performed. 

January 31, 2011 6.1 Section 21, Emission of Radio 

Frequency Energy - Radiated 

1 Complied 

Complied 

See the individual test method contained in Paragraph 6.1 of this test report for a full 

description of the procedures utilized and test results obtained. 

Retlif Testing Laboratories 

Report No. R-1608P 

Page 21 of 95 
6.1 RTCA/DO-160F, Section 21, RF Radiated Emissions, Category M, 

100 MHz to 6 GHz 

6.1.1 Purpose 

The purpose of this test method was to verify the EUT does not emit undesired RF noise by 

radiation from system enclosure and interconnecting harnesses in excess of the specified 

limits. 

6.1.2 Test Description 

Compliance with the specified radiated emissions requirements were evaluated by 

measuring the RF emissions present at a distance of 1 meter from the equipment under 

test over the frequency range of 100 MHz to 6 GHz. The measured RF emission was 

compared to the limit curve shown in Figure 4 below for compliance determination. This 

curve was for Category M equipment and was derived from Figure 21-6 of RTCA/DO-160F. 

Unless otherwise specified by EUT test specification, radiated ambient measurements 

were required only if EUT emissions exceeded or were within 6 dB of specified limit. When 

required, radiated emissions were measured with the EUT "off" and support equipment 

on . 

Figure 4 - Radiated RF Emissions, Category M Test Limit 

80 7 

*—'•-+ • » • 

Frequency 

MHz 

100 

108 

108 

152 

152 

960 

960 

1215 

1215 

1525 

1525 

1680 

1680 

6000 

Limit Level 

dBuV/m 

44.6 

45.13 

35 

37.5 

47.5 

60.29 

50.3 

52 

61.92 

63.5 

53.5 

54 

64.17 

73 

1000 

Frequency (MHz) 

10000 

Retlif Testing Laboratories 

Report No. R-1608P 

Page 22 of 95 
Figure 5 - Antenna Positions Setup 

D 

100 fc 20CM.HI 

2(X IC lOOCMHz 

• CtcftCGHi 

-» -• K: 

cN:a^CNO'*-CN:a-.cr\:tr-.cr*.-c^-.CN;t r 

6.1.3 Test Setup 

The EUT was configured as shown in Figure 2 - General Test Setup, Configuration 1 and 

Figure 3 - General Test Setup, Configuration 2 within a shielded enclosure employing RF 

absorber material. The test instrumentation was configured as shown in Figure 6. The 

length of the power leads from the EUT to the five microhenry line impedance stabilization 

networks were one meter long. All power returns defined as local, less than one (1) meter 

in length, were separated from cable bundles and connected directly to the ground plane. 

The RF port(s) of the LISN(s) were terminated into 50 ohms. All measurements were 

made using the Peak detector function of the interference measuring equipment Test 

antennas were connected to the interference analyzer by means of fifty ohm shielded 

cabling. Test antenna versus frequency range of use was in accordance with Table 8. For 

all testing, the test antennas were positioned for both horizontal and vertical polarizations. 

Table 8 - Radiated RF Emissions, Test Antennas 

Test Antenna 

Biconical Antenna 

Double Ridged Guide 

Double Ridged Guide 

Frequency Range 

100 MHz to 200 MHz 

200 MHz to 1 GHz 

1 GHz to 6 GHz 

Page 23 of 95 

Retlif Testing Laboratories 

Report No. R-1608P 
Figure 6 - Radiated RF Emissions, 100 MHz to 6 GHz, Test Setup 

Field 

Calibrabon 

Point 

^ TrantmiHT 

1 meier AntennaJ P 

If 

End of Exposed Cable 

unstiialded cable msv be shielded from 

here to wall. 

E-FiekJ 

Power Ampltfier 

Signal Generator 

© 

ft Retlif Testing Laboratories 

Report No. R-1608P 

Page 24 of 95 
6.1.4 Test Equipment 

The details of the test equipment utilized during the 

shown below: 

January 13, 2011 

EN 

713 

713D 

713E 

713F 

8017 

8276 

8317 

8398 

6399 

Manufacturer Description 

ROHDE 4 SCHWARZ EMI TEST RECEIVER 

MICRO-COAX CABLE ASSEMBLY 

MICRO-COAX CABLE ASSEMBLY 

MICRO-COAX CABLE ASSEMBLY 

EMCO DOUBLE RIDGE GUIDE 

ELGAR TRANSFORMER 

AGILENT / HP PRE-AMPLIFIER 

EMCO BICONICAL ANTENNA 

EMCO DOUBLE RIDGE GUIDE 

Re-Test - January 31, 2011 

EN 

713 

713D 

713E 

713F 

8017 

8276 

8317 

6398 

6399 

8442 

8442A 

Manufacturer Description 

ROHDE & SCHWARZ EMI TEST RECEIVER 

MICRO-COAX CABLE ASSEMBLY 

MICRO-COAX CABLE ASSEMBLY 

MICRO-COAX CABLE ASSEMBLY 

EMCO DOUBLE RIDGE GUIDE 

ELGAR TRANSFORMER 

AGILENT / HP PRE-AMPLIFIER 

EMCO BICONICAL ANTENNA 

EMCO DOUBLE RIDGE GUIDE 

UNIVERSAL SHIELDED ENCLOSURE -

SHIELDING TEST CHAMBER 

UNIVERSAL SHIELDED ENCLOSURE -

SHIELDING SUPPORT CHAMBER 

Range 

performance of this test method are | 

Model No. 

20 Hz-26.5 GHz ESIB26 

3 FT. 

6 FEET 

25 FT 

1 -18 GHz 

2.5-13 

UFB311A1-0360-

50U50U 

UFB311A1-0720-

50U50U 

UFB311A1-2400-

50U50U 

3115 

Inspect Before Use 

1-26.5 GHz. 30 dB 8449B 

20 - 200 MHz 

200 - 2500 MHz 

Range 

3104C 

3106B 

Modei No. 

20 Hz-26.5 GHz ESIB26 

3 FT. 

6 FEET 

25 FT 

1 -18 GHz 

UFB311A1-0360-

50U50U 

UFB311A1-0720-

50U50U 

UFB311A1-2400-

50U50U 

3115 

2.5-13 

1-26.5 GHz, 30 dB B449B 

20 - 200 MHz 

200 - 2500 MHi 

lOOdB, 14kf-lzlOOdB. 14liHz-

<3> 

3104C 

3106B 

10GHz 10X20X12 

10GHz 8X20X12 

Cal Date 

5/18/2010 

10/7/2010 

10/7/2010 

10/7/2010 

9/2/2009 

5/26/2010 

1/16/2010 

8/9/2010 

Cai Date 

5/18/2010 

10/7/2010 

10/7/2010 

10/7/2010 

9/2/2009 

Due Date 

5/18/2011 

10/7/2011 

10/7/2011 

10/7/2011 

9/2/2011 

5/26/2011 

1/16/2012 

8/9/2011 

Due Date 

5/18/2011 

10/7/2011 

10/7/2011 

10/7/2011 

9/2/2011 

Inspect Before Use | 

5/26/2010 

1/16/2010 

8/9/2010 

1/4/2010 

1/4/2010 

5/26/2011 

1/16/2012 

6/9/2011 

2/4/2011 

2/4/2011 

Retlif Testing Laboratories 

Report No. R-1608P 

Page 25 of 95 
6.1.5 Test Procedure 

With the test instrumentation and the EUT were configured as stated in paragraph 6.1.3, 

the following steps were performed: 

1. The test instrumentation was configured as shown in Figure 6. 

2. EUT area of maximum radiation was determined by probing with a near field 

probe. The EUT was repositioned with the area of maximum radiation facing 

the test antenna. 

3. The EUT was operated in accordance with Paragraph 5.5, herein. 

4. The interference analyzer was configured with the appropriate bandwidths 

and sweep times as specified in Paragraph 4.3.3, herein. 

5. All measured emissions were recorded and compared to the specified limit. 

6. If radiated emissions observed exceeded or were within 6 dB of specified 

limits, ambient scans were recorded over the designated frequency range 

with the EUT powered "off "and the support equipment "on". 

7. Steps 6 and 7 were repeated over the frequency range from 100 MHz to 200 

MHz using a Biconical Antenna with the appropriate bandwidths and sweep 

times as specified in Paragraph 4.3.3, herein. Measurements were made with 

the Biconical Antenna positioned in both horizontal and vertical polarizations. 

8. Steps 6 and 7 were repeated over the frequency range from 200 MHz to 1 

GHz using a Double Ridged Guide Antenna with the appropriate bandwidths 

and sweep times as specified in Paragraph 4.3.3, herein. Measurements 

were made with the Double Ridged Guide Antenna positioned in both the 

horizontal and vertical polarizations. 

9. Steps 6 and 7 were repeated over the frequency range from 1 to 6 GHz using 

a Double Ridged Guide Antenna with the appropriate bandwidths and sweep 

times as specified in Paragraph 4.3.3, herein. Measurements were made with 

the Double Ridged Guide Antenna positioned in both the horizontal and 

vertical polarizations. 

Retlif Testing Laboratories 

Report No. R-1608P 

Page 26 of 95 
6.1.6 Test Results 

January 13, 2011 

Configuration #1 : 

The EUT produced a single discrete emission above the specified limit at 151.303 MHz 

with the antenna in the vertical polarization. This emission was 37.99 dBuV/m, 0.52 dB 

above the limit of 37.49 dBuV/m. 

January 31,2011 

After the modifications detailed in Paragraph 5.4.1 were performed the EUT was retested 

and found to comply with the specified requirements of RTCA/DO-160F, Section 21, 

Radiated RF Emissions. 

January 13, 2011 

Configuration #2: 

The EUT produced a single discrete emission above the specified limit at 150.301 MHz 

with the antenna in the vertical polarization. This emission was 38.36 dBuV/m, 0.94 dB 

above the limit of 37.42 dBuV/m. 

January 31, 2011 

After the modifications detailed in Paragraph 5.4.1 were performed the EUT was retested 

and found to comply with the specified requirements of RTCA/DO-160F, Section 21, 

Radiated RF Emissions. 

See the following test photographs and data sheets for a complete presentation of the test 

results obtained. 

Page 27 of 95 

Retlif Testing Laboratories 

Report No. R-1608P 
Test Photographs 

Radiated RF Emissions 

January 13, 2011 - Configuration 1 

Retlif Testing Laboratories 

Report No. R-1608P 

Page 28 of 95 
Test Photographs 

Radiated RF Emissions 

Horizontal, Biconical, 100 MHz to 200 MHz 

Vertical, Biconical, 100 MHz to 200 MHz 

Retlif Testing Laboratories 

Report No. R-1608P 

Page 29 of 95 
Test Photographs 

Radiated RF Emissions 

Horizontal, Double Ridged Guide, 200 MHz to 1.0 GHz 

Vertical, Double Ridged Guide, 200 MHz to 1.0 GHz 

Retlif Testing Laboratories 

Report No. R-1608P 

Page 30 of 95 
Test Photographs 

Radiated RF Emissions 

Horizontal, Double Ridged Guide, 1.0 GHz to 6.0 GHz 

Vertical, Double Ridged Guide, 1.0 GHz to 6.0 GHz 

Retlif Testing Laboratories 

Report No. R-1608P 

Page 31 of 95 
Re - Test Photographs 

Radiated RF Emissions 

January 31, 2011 - Configuration 1 

Retlif Testing Laboratories 

Report No. R-1608P 

Page 32 of 95 
Test Photographs 

Radiated RF Emissions 

Horizontal, Biconical, 100 MHz to 200 MHz 

Vertical, Biconical, 100 MHz to 200 MHz 

Retlif Testing Laboratories 

Report No. R-1608P 

Page 33 of 95 
Test Photographs 

Radiated RF Emissions 

Horizontal, Double Ridged Guide. 200 MHz to 1.0 GHz 

Vertical, Double Ridged Guide, 200 MHz to 1.0 GHz 

Retiif Testing Laboratories 

Report No. R-1608P 

Page 34 of 95 
Test Photographs 

Radiated RF Emissions 

Horizontal, Double Ridged Guide, 1.0 GHz to 6.0 GHz 

Vertical, Double Ridged Guide, 1.0 GHz to 6.0 GHz 

Retlif Testing Laboratories 

Report No. R-1608P 

Page 35 of 95 
Test Photographs 

Radiated RF Emissions 

January 13, 2011 - Configuration 2 

Retlif Testing Laboratories 

Report No. R-1608P 

Page 36 of 95 
Test Photographs 

Radiated RF Emissions 

Horizontal, Biconical, 100 MHz to 200 MHz 

Vertical, Biconical, 100 MHz to 200 MHz 

Retlif Testing Laboratories 

Report No. R-1608P 

Page 37 of 95 
Test Photographs 

Radiated RF Emissions 

Horizontal, Double Ridged Guide, 200 MHz to 1.0 GHz 

..•t^ . 

Vertical, Double Ridged Guide, 200 MHz to 1.0 GHz 

Retlif Testing Laboratories 

Report No. R-1608P 

Page 38 of 95 
Test Photographs 

Radiated RF Emissions 

Horizontal, Double Ridged Guide, 1.0 GHz to 6.0 GHz 

Vertical, Double Ridged Guide, 1.0 GHz to 6.0 GHz 

Retlif Testing Laboratories 

Report No. R-1608P 

Page 39 of 95 
Re - Test Photographs 

Radiated RF Emissions 

January 31, 2011 - Configuration 2 

Retlif Testing Laboratories 

Report No. R-1608P 

Page 40 of 95 
Test Photographs 

Radiated RF Emissions 

Horizontal, Biconical, 100 MHz to 200 MHz 

Vertical, Biconical, 100 MHz to 200 MHz 

Retlif Testing Laboratories 

Report No. R-1608P 

Page 41 of 95 
Test Photographs 

Radiated RF Emissions 

Horizontal, Double Ridged Guide, 200 MHz to 1.0 GHz 

Vertical, Double Ridged Guide, 200 MHz to 1.0 GHz 

Retlif Testing Laboratories 

Report No. R-1608P 

Page 42 of 95 
Test Photographs 

Radiated RF Emissions 

Horizontal, Double Ridged Guide, 1.0 GHz to 6.0 GHz 

Vertical, Double Ridged Guide, 1.0 GHz to 6.0 GHz 

Retlif Testing Laboratories 

Report No. R-1608P 

Page 43 of 95 
RTCA/DO-160F, Section 21.5, Radiated RF Emissions 

Test Data 

January 13, 2011 - Configuration 1 

Page 44 of 95 

Retlif Testing Laboratories 

Report No. R-1608P 
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RTCA/DO-160F, Section 21.5, Radiated RF Emissions 

Sweep Tables 

Retlif Testing Laboratories 

Test Report No. R-XXXX 

Page 51 of 95 
SWEEP TABLE: "DO-ieOF RE 100MHz' 

Short Description: 

Unit: depV/m 

Detector: 

Radiated Emissions 

Mode: 

Curve 1: MaxPeak GlearWrite 

Subrange 1: 

Start Frequency: 

Stop Frequency: 

Measure Time: 

IF Bandwidth: 

100.0 MHz 

200.0 MHz 

150.0 s 

10 kHz 

Receiver: 

Signal Path: 

Meas. Mode: 

Tracking Gen. 

Input: 

Preamplifier: 

RFAtt.: 

Ref. Level: 

Min. RF Att.: 

IFAtt.: 

ESIX Transducer: PAEN8398 

None System Transducer; None 

Lin Add.Transd. 1: PAEN713F 

- Add. Transd. 2: PA EN713E 

1 Add. Transd. 3: None 

20 dB Op. Range: 

10 dB Preselection: On 

-25.0 dBm Rep. by Device: --

- Option: 

- Video Bandwidth: 100 kHz 

Curve 1 

Curve 2 

Curve 3 

Curve 4 

On Repetition: Single 

Off Stop Mark: Off 

Off Stop Message: Off 

Off Stop Message: 

Page 52 of 95 

Retlif Testing Laboratories 

Test Report No. R-XXXX 
SWEEP TABLE: "DO-160F RElOOMMz' 

Short Description: 

Unit: dBpV/m 

Radiated Emissions 

Detector: Mode: 

Curve 1: MaxPeak ClearWhte 

Subrange 1: 

Start Frequency: 

Stop Frequency: 

Measure Time: 

IF Bandwidth: 

Receiver: 

Signal Path: 

Meas. Mode: 

Tracking Gen.: 

Input: 

Preamplifier: 

RFAtt.: 

Ref. Level: 

Min. RFAtt.: 

IFAtt.: 

200.0 MHz 

400.0 MHz 

300.0 s 

10 kHz 

ESIX Transducer: PAEN8399 1M 

None System Transducer: None 

Lin Add. Transd. 1: PA EN713E 

-- Add. Transd. 2: PA EN713F 

1 Add. Transd. 3: None 

20 dB Op. Range: 

20 dB Preselection: On 

-25.0 dBm Rep. by Device: --

~ Option: 

- Video Bandwidth: 100 kHz 

Curve 1 

Curve 2 

Curves 

Curve 4 

On Repetition: Single 

Off Stop Mark: Off 

Off Stop Message: Off 

Off Stop Message: 

Retlif Testing Laboratories 

Test Report No. R-XXXX 

Page 53 of 95 
Subrange 2: 

Start Frequency: 

Stop Frequency: 

Measure Time: 

IF Bandwidth: 

400.0 MHz 

1.0 GHz 

90.0 s 

100 kHz 

Receiver: 

Signal Path: 

Meas. Mode: 

Tracking Gen. 

Input: 

Preamplifier: 

RFAtt.: 

Ref. Level: 

Min. RFAtt.: 

IFAtt.: 

ESIX Transducer: PAEN8399 1M 

None System Transducer; None 

Lin Add. Transd. 1: PA EN713E 

-- Add. Transd. 2: PA EN713F 

1 Add. Transd. 3: None 

20 dB Op. Range: 

10 dB Preselection: On 

-25.0 dBm Rep. by Device: -

- Option: 

- Video Bandwidth: 200 kHz 

Curve 1 

Curve 2 

Curve 3 

Curve 4 

On Repetition; Single 

Off Stop Mark: Off 

Off Stop Message: Off 

Off Stop Message: 

Page 54 of 95 

Retlif Testing Laboratories 

Test Report No. R-XXXX 
SWEEP TABLE: "DO-160F RE 1to 6GHz' 

Short Description: 

Unit: dB|jV/m 

Radiated Emissions 

Detector; Mode: 

Curve 1; MaxPeak GlearWrite 

Subrange 1: 

Start Frequency: 

Stop Frequency; 

Measure Time: 

IF Bandwidth; 

Receiver: 

Signal Path: 

Meas. Mode: 

Tracking Gen.; 

Input: 

Preamplifier: 

RFAtt.: 

Ref. Level: 

Min. RFAtt.; 

IFAtt.: 

1.0 GHz 

6.0 GHz 

300.0 s 

1 MHz 

ESIX Transducer: PAEN8017DRG 

None System Transducer; None 

Lin Add. Transd. 1; PA EN713D& 713E 

- Add. Transd. 2: PAEN8317pamp 

1 Add. Transd. 3: PAEN713F 

Off Op. Range: 

10 dB Preselection: On 

-25.0 dBm Rep. by Device: ~ 

- Option: 

- Video Bandwidth: 1 MHz 

Curve 1 

Curve 2 

Curve 3 

Curve 4 

On Repetition: Single 

Off Stop Mark: Off 

Off Stop Message; Off 

Off Stop Message: 

Retlif Testin g Laboratorie s 

Test Report No. R-XXXX 

Page 55 of 95 
RTCA/DO-160F, Section 21.5, Radiated RF Emissions 

Re-Test Data 

January 31, 2011 - Configuration 1 

Retlif Testing Laboratories 

Test Report No. R-XXXX 

Page 56 of 95 
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RTCA/DO-160F, Section 21.5, Radiated RF Emissions 

Sweep Tables 

Retlif Testing Laboratories 

Report No. R-1608P 

Page 63 of 95 
SWEEP TABLE: "DO-160FRE 100MHz' 

Short Description: 

Unit: dB|jV/m 

Radiated Emissions 

Detector; Mode: 

Curve 1: MaxPeak ClearWrite 

Subrange 1: 

Start Frequency: 

Stop Frequency: 

Measure Time: 

IF Bandwidth: 

Receiver; 

Signal Path: 

Meas. Mode: 

Tracking Gen.: 

Input; 

Preamplifier: 

RFAtt.: 

Ref. Level: 

Min. RF Att.: 

IFAtt; 

100.0 MHz 

200.0 MHz 

150.0 s 

10 kHz 

ESIX Transducer: PAEN8398 

None System Transducer: None 

Lin Add. Transd. 1; PA EN713F 

- Add. Transd. 2: PA EN713E 

1 Add. Transd. 3: None 

20 dB Op. Range; 

10 dB Preselection: On 

-25.0 dBm Rep. by Device; --

- Option: 

- Video Bandwidth: 100 kHz 

Curve 1 

Curve 2 

Curve 3 

Curve 4 

On Repetition; Single 

Off Stop Mark: Off 

Off Stop Message: Off 

Off Stop Message: 

Retlif Testing Laboratories 

Report No. R-1608P 

Page 64 of 95 
SWEEP TABLE: "PO-160F RE 200MHz' 

Short Description; 

Unit: dB|jV/m 

Detector; 

Curve 1: MaxPeak 

Subrange 1: 

Start Frequency; 

Stop Frequency: 

Measure Time: 

IF Bandwidth; 

Receiver: 

Signal Path; 

Meas. Mode; 

Tracking Gen.: 

Input: 

Preamplifier: 

RFAtt.: 

Ref. Level: 

Min. RFAtt.; 

IFAtt: 

Radiated Emissions 

Mode; 

ClearWrite 

200.0 MHz 

400.0 MHz 

300.0 s 

10 kHz 

ESIX Transducer; PAEN8399 1M 

None System Transducer: None 

Lin Add.Transd. 1: PAEN713E 

-- Add. Transd. 2: PAEN713F 

1 Add. Transd. 3: None 

20 dB Op. Range: 

20 dB Preselection; On 

-25.0 dBm Rep. by Device; -

-- Option; 

--Video Bandwidth: 100 kHz 

Curve 1 

Curve 2 

Curve 3 

Curve 4 

On Repetition; Single 

Off Stop Mark: Off 

Off Stop Message: Off 

Off Stop Message; 

Page 65 of 95 

Retlif Testing Laboratories 

Report No. R-1608P 
Subrange 2: 

Start Frequency: 

Stop Frequency: 

Measure Time: 

IF Bandwidth: 

400.0 MHz 

1.0 GHz 

90.0 s 

100 kHz 

Receiver: 

Signal Path; 

Meas. Mode; 

Tracking Gen. 

Input: 

Preamplifier: 

RFAtt.: 

Ref Level: 

Min. RFAtt.: 

IFAtt.; 

ESIX Transducer; PAEN8399 1M 

None System Transducer: None 

Lin Add. Transd. 1: PA EN713E 

- Add. Transd. 2: PA EN713F 

1 Add. Transd. 3; None 

20 dB Op. Range: 

10 dB Preselection: On 

-25.0 dBm Rep. by Device: -

- Option: 

- Video Bandwidth: 200 kHz 

Curve 1: 

Curve 2: 

Curve 3: 

Curve 4; 

On Repetition; Single 

Off Stop Mark: Off 

Off Stop Message; Off 

Off Stop Message; 

Page 66 of 95 

Retlif Testing Laboratories 

Report No. R-1608P 
SWEEP TABLE: "DO-160F RE Ito 6GHz" 

Short Description: Radiated Emissions 

Unit dBpV/m 

Detector: 

Curve 1: MaxPeak 

Subrange 1; 

Start Frequency; 

Stop Frequency: 

Measure Time; 

IF Bandwidth; 

Receiver: 

Signal Path; 

Meas. Mode: 

Tracking Gen.; 

Input; 

Preamplifier: 

RFAtt.; 

Ref Level: 

Min. RFAtt.: 

IFAtt.; 

Mode: 

ClearWrite 

1.0 GHz 

6.0 GHz 

300.0 s 

1 MHz 

ESIX Transducer; PAEN8017DRG 

None System Transducer: None 

Lin Add.Transd. 1: PA EN713D & 713E 

-- Add. Transd. 2: PAEN8317pamp 

1 Add. Transd. 3: PAEN713F 

Off Op. Range: 

10 dB Preselection: On 

-25.0 dBm Rep. by Device; -

-- Option: 

- Video Bandwidth: 1 MHz 

Curve 1 

Curve 2 

Curve 3 

Curve 4 

On Repetition: Single 

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Retlif Testing Laboratories 

Report No. R-1608P 

Page 67 of 95 
RTCA/DO-160F, Section 21.5, Radiated RF Emissions 

Test Data 

January 13, 2011 - Configuration 2 

Page 68 of 95 

Retlif Testing Laboratories 

Report No. R-1608P 
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RTCA/DO-160F, Section 21.5, Radiated RF Emissions 

Sweep Tables 

Retlif Testing Laboratories 

Test Report No. R-XXXX 

Page 75 of 95 
SWEEP TABLE: "DO-160FRE 100MHz' 

Short Description: 

Unit: dBpV/m 

Detector: 

Curve 1: MaxPeak 

Subrange 1: 

Start Frequency: 

Stop Frequency: 

Measure Time: 

IF Bandwidth: 

Receiver: 

Signal Path: 

Meas. Mode: 

Tracking Gen.: 

Input: 

Preamplifier: 

RFAtt.: 

Ref. Level: 

Min. RFAtt.: 

IFAtt.: 

Radiated Emissions 

Mode: 

ClearWrite 

100.0 MHz 

200.0 MHz 

150.0 s 

10 kHz 

ESIX Transducer: PAEN8398 

None System Transducer: None 

Lin Add. Transd. 1: PA EN713F 

- Add. Transd. 2: PA EN713E 

1 Add. Transd. 3: None 

20 dB Op. Range: 

10 dB Preselection: On 

-25.0 dBm Rep. by Device: -

- Option: 

- Video Bandwidth: 100 kHz 

Curve 1 

Curve 2 

Curve 3 

Curve 4 

On Repetition: Single 

Off Stop Mark: Off 

Off Stop Message: Off 

Off Stop Message: 

Page 76 of 95 

Retlif Testing Laboratories 

Test Report No. R-XXXX 
SWEEP TABLE: "DO-ldOF RE 200MHz' 

Short Description: 

Unit: dB|jV/m 

Radiated Emissions 

Detector: Mode: 

Curve 1: MaxPeak ClearWrite 

Subrange 1: 

Start Frequency: 

Stop Frequency: 

Measure Time: 

IF Bandwidth: 

Receiver: 

Signal Path: 

Meas. Mode: 

Tracking Gen.: 

Input: 

Preamplifier: 

RFAtt.: 

Ref. Level: 

Min. RFAtt.: 

IFAtt.: 

200.0 MHz 

400.0 MHz 

300.0 s 

10 kHz 

ESIX Transducer: PAEN8399 1M 

None System Transducer: None 

Lin Add. Transd. 1: PA EN713E 

.- Add. Transd. 2: PAEN713F 

1 Add. Transd. 3: None 

20 dB Op. Range: 

20 dB Preselection: On 

-25.0 dBm Rep. by Device: --

- Option: 

-- Video Bandwidth: 100 kHz 

Curve 1 

Curve 2 

Curve 3 

Curve 4 

On Repetition: Single 

Off Stop Mark: Off 

Off Stop Message: Off 

Off Stop Message: 

Retlif Testing Laboratories 

Test Report No. R-XXXX 

Page 77 of 95 
Subrange 2: 

Start Frequency: 

Stop Frequency: 

Measure Time: 

IF Bandwidth: 

400.0 MHz 

1.0 GHz 

90.0 s 

100 kHz 

Receiver: 

Signal Path: 

Meas. Mode: 

Tracking Gen. 

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RFAtt.: 

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Min. RFAtt.: 

IFAtt.: 

ESIX Transducer: PAEN8399 1M 

None System Transducer: None 

Lin Add. Transd. 1: PA EN713E 

- Add. Transd. 2: PA EN713F 

1 Add. Transd. 3: None 

20 dB Op. Range: 

10 dB Preselection: On 

-25.0 dBm Rep. by Device: ~ 

-- Option: 

- Video Bandwidth: 200 kHz 

Curve 1 

Curve 2 

Curve 3 

Curve 4 

On Repetition: Single 

Off Stop Mark: Off 

Off Stop Message: Off 

Off Stop Message: 

Retlif Testing Laboratories 

Test Report No. R-XXXX 

Page 78 of 95 
SWEEP TABLE: "DO^IGOF RE it o 6GHz' 

Short Description: 

Unit: dBpV/m 

Detector: 

Curve 1: MaxPeak 

Subrange 1: 

Start Frequency: 

Stop Frequency: 

Measure Time: 

IF Bandwidth: 

Receiver: 

Signal Path: 

Meas. Mode: 

Tracking Gen.: 

Input: 

Preamplifier: 

RFAtt.: 

Ref. Level: 

Min. RFAtt.: 

IFAtt.: 

Radiated Emissions 

Mode: 

ClearWrite 

1.0 GHz 

6.0 GHz 

300.0 s 

1 MHz 

ESIX Transducer: PAEN8017DRG 

None System Transducer: None 

Lin Add.Transd. 1: PA EN713D & 713E 

-- Add. Transd. 2: PAEN8317pamp 

1 Add. Transd. 3: PAEN713F 

Off Op. Range: 

10 dB Preselection: On 

-25.0 dBm Rep. by Device: ~ 

-- Option: 

-- Video Bandwidth: 1 MHz 

Curve 1 

Curve 2 

Curve 3 

Curve 4 

On Repetition: Single 

Off Stop Mark: Off 

Off Stop Message: Off 

Off Stop Message: 

Page 79 of 95 

Retlif Testing Laboratories 

Test Report No. R-XXXX 
RTCA/DO-160F, Section 21.5, Radiated RF Emissions 

Re-Test Data 

January 31, 2011 - Configuration 2 

Retlif Testing Laboratories 

Test Report No. R-XXXX 

Page 80 of 95 
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RTCA/DO-160F, Section 21.5, Radiated RF Emissions 

Sweep Tables 

Retlif Testing Laboratories 

Report No. R-1608P 

Page 87 of 95 
SWEEP TABLE: "DO-160F RE 100MHz' 

Short Description: 

Unit: dBpV/m 

Radiated Emissions 

Detector: Mode: 

Curve 1: MaxPeak ClearWrite 

Subrange 1: 

Start Frequency: 

Stop Frequency: 

Measure Time: 

IF Bandwidth: 

Receiver: 

Signal Path: 

Meas. Mode: 

Tracking Gen.: 

Input: 

Preamplifier: 

RFAtt.: 

Ref. Level: 

Min. RFAtt.: 

IFAtt: 

100.0 MHz 

200.0 MHz 

150.0 s 

10 kHz 

ESIX Transducer: PAEN8398 

None System Transducer: None 

Lin Add. Transd. 1: PA EN713F 

- Add. Transd. 2: PA EN713E 

1 Add. Transd. 3: None 

20 dB Op. Range: 

10 dB Preselection: On 

-25.0 dBm Rep. by Device: -

- Option: 

-- Video Bandwidth: 100 kHz 

Curve 1 

Curve 2 

Curves 

Curve 4 

On Repetition: Single 

Off Stop Mark: Off 

Off Stop Message: Off 

Off Stop Message: 

Page 88 of 95 

Retlif Testing Laboratories 

Report No. R-1608P 
SWEEP TABLE: "DO-160F RE 200MHz" 

Short Description: Radiated Emissions 

Unit: dB|jV/m 

Detector: Mode: 

Curve 1: MaxPeak ClearWrite 

Subrange 1: 

Start Frequency: 

Stop Frequency: 

Measure Time: 

IF Bandwidth: 

Receiver: 

Signal Path: 

Meas. Mode: 

Tracking Gen.: 

Input; 

Preamplifier: 

RF Att.: 

Ref. Level: 

Min. RFAtt.: 

IFAtt: 

200.0 MHz 

400.0 MHz 

300.0 s 

10 kHz 

ESIX Transducer: PAEN8399 1M 

None System Transducer: None 

Lin Add. Transd. 1: PA EN713E 

-- Add. Transd. 2: PA EN713F 

1 Add. Transd. 3: None 

20 dB Op. Range: 

20 dB Preselection: On 

-25.0 dBm Rep. by Device: -

~ Option: 

- Video Bandwidth: 100 kHz 

Curve 1: 

Curve 2: 

Curve 3: 

Curve 4: 

On Repetition: Single 

Off stop Mark: Off 

Off Stop Message: Off 

Off Stop Message: 

Page 89 of 95 

Retlif Testing Laboratories 

Report No. R-1608P 
Subrange 2: 

start Frequency: 

stop Frequency: 

Measure Time: 

IF Bandwidth: 

400.0 MHz 

1.0 GHz 

90.0 s 

100 kHz 

Receiver: 

Signal Path: 

Meas. Mode: 

Tracking Gen. 

Input: 

Preamplifier: 

RF Att.; 

Ref. Level: 

Min. RFAtt.: 

IF Att.: 

ESIX Transducer: PAEN8399 1M 

None System Transducer: None 

Lin Add. Transd. 1: PA EN713E 

~ Add. Transd. 2: PA EN713F 

1 Add. Transd. 3: None 

20 dB Op. Range: 

10 dB Preselection: On 

-25.0 dBm Rep. by Device: -

- Option: 

- Video Bandwidth; 200 kHz 

Curve 1 

Curve 2 

Curves 

Curve 4 

On Repetition; Single 

Off stop Mark: Off 

Off stop Message; Off 

Off stop Message: 

Retlif Testing Laboratories 

Report No. R-1608P 

Page 90 of 95 
SWEEP TABLE: "DO-160F RE Ito 6GHz' 

Short Description: 

Unit dBpV/m 

Detector; 

Curve 1: MaxPeak 

Subrange 1: 

start Frequency: 

stop Frequency; 

Measure Time: 

IF Bandwidth: 

Receiver: 

Signal Path: 

Meas. Mode; 

Tracking Gen.: 

Input: 

Preamplifier: 

RFAtt.; 

Ref. Level: 

Min. RF Att.; 

IFAtt.: 

Radiated Emissions 

Mode: 

ClearWrite 

1.0 GHz 

6.0 GHz 

300.0 s 

1 MHz 

ESIX Transducer; PAEN8017DRG 

None System Transducer; None 

Lin Add. Transd. 1; PA EN713D & 713E 

- Add. Transd. 2: PAEN8317pamp 

1 Add. Transd. 3: PAEN713F 

Off Op. Range: 

10 dB Preselection: On 

-25.0 dBm Rep. by Device: -

- Option; 

- Video Bandwidth; 1 MHz 

Curve 1; 

Curve 2: 

Curve 3; 

Curve 4: 

On Repetition: Single 

Off Stop Mark; Off 

Off Stop Message: Off 

Off Stop Message: 

Page 91 of 95 

Retlif Testing Laboratories 

Report No. R-1608P 
RTCA/DO-160F, Section 21.5, Radiated RF Emissions 

Transducer Factors 

Retlif Testing Laboratories 

Report No. R-1608P 

Page 92 of 95 
CORRECTION FACTORS 

EQUIPMENT TYPE: Double Ridge Guide Antenna 

MODEL: 3115 

S/N: 2425 

FREQUENCY RANGE: 1 -18 GHz 

RETLIF EN: 8017 

CALIBRATION DATE: 09/02/09 

DUE DATE: 09/02/11 

1 Meter 

Frequency 

(MHz) 

1,000.00 

1,500.00 

2,000.00 

2,500.00 

3,000.00 

3,500.00 

4.000.00 

4,500.00 

5.000.00 

5,500.00 

6,000.00 

6,500.00 

7,000.00 

7,500.00 

8,000.00 

8,500.00 

9,000.00 

9,500.00 

10,000.00 

10,500.00 

11,000.00 

11,500.00 

12.000.00 

12.500.00 

13,000.00 

13.500.00 

14,000.00 

14,500.00 

15,000.00 

15,500.00 

16,000.00 

16,500.00 

17,000.00 

17,500.00 

18,000.00 

Antenna 

Factor 

(dB/m) 

25.8 

26.0 

27.9 

28.7 

30.4 

31.8 

32.9 

32.9 

34.0 

34.6 

35.0 

35.3 

36.5 

37.3 

37.4 

37.9 

38.3 

38.4 

38.7 

38.8 

39.0 

39.3 

39.0 

38.8 

39.5 

40.6 

40.8 

40.9 

39.5 

38.2 

38.2 

39.34 

41.5 

44.3 

47.0 

® 

ri 

Page 93 of 95 

Retlif Testing Laboratories 

Report No. R-1608P 
CORRECTION FACTORS 

EQUIPMENT TYPE: Biconical Antenna 

MODEL: 3104C 

S/N:00086623 

FREQUENCY RANGE: 20 MHz - 200 MHz 

Frequency 

MHz 

20 

25 

30 

35 

40 

45 

50 

60 

70 

80 

90 

100 

110 

120 

125 

1 Meter 

Antenna 

Factor 

13.6 

11.7 

11.2 

11.4 

12.0 

12.3 

12.0 

11.3 

9.9 

8.2 

9.5 

10.7 

12.6 

14.3 

14.6 

Frequency 

MHz 

130 

140 

150 

160 

170 

175 

180 

190 

200 

ri 

RETLIF EN: 8398 

CALIBRATION DATE: 01-16-10 

DUE DATE: 01-16-12 

Antenna 

Factor 

14.4 

13.5 

12.9 

13.3 

14.9 

15.8 

16.6 

17.9 

17.3 

Retlif Testing Laboratories 

Report No. R-1608P 

Page 94 of 95 
CORRECTION FACTORS 

EQUIPMENT TYPE: Double Ridqe Guide Antenna 

MODEL: 3106B 

S/N:00084096 

FREQUENCY RANGE: 200 MHz - 2500 MHz 

Frequency 

(MHz) 

200.0 

225.0 

250.0 

275.0 

300.0 

325.0 

350.0 

375.0 

400.0 

425.0 

450.0 

475.0 

500.0 

525.0 

550.0 

575.0 

600.0 

625.0 

650.0 

675.0 

700.0 

725.0 

750.0 

775.0 

1.0 Meter 

Factor 

dB/m 

11.2 

11.7 

12.0 

12.4 

13.0 

13.5 

13.9 

14.2 

14.1 

14.1 

15.4 

16.2 

16.7 

16.5 

16.0 

17.3 

17.6 

17.6 

17.7 

17.9 

18.0 

18.4 

18.5 

18.3 

Frequency 

(MHz) 

800.0 

825.0 

850.0 

875.0 

900.0 

925.0 

950.0 

975.0 

1000.0 

1025.0 

1050.0 

1075.0 

1100.0 

1125.0 

1150.0 

1175.0 

1200.0 

1225.0 

1250.0 

1275.0 

1300.0 

1325.0 

1350.0 

1375.0 

Factor 

dB/m 

19.1 

19.4 

19.9 

20.0 

20.4 

21.1 

22.4 

22.8 

23.0 

23.3 

22.5 

22.6 

23.4 

22.9 

22.8 

22.8 

22.9 

23.7 

23.9 

24.0 

25.3 

24.5 

25.7 

25.3 

Frequency 

(MHz) 

1400.0 

1425.0 

1450.0 

1475.0 

1500.0 

1525.0 

1550.0 

1575.0 

1600.0 

1625.0 

1650.0 

1675.0 

1700.0 

1725.0 

1750.0 

1775.0 

1800.0 

1825.0 

1850.0 

1875.0 

1900.0 

1925.0 

1950.0 

1975.0 

ri 

RETLIF EN: 8399 

CALIBRATION DATE: 08/09/2010 

DUE DATE: 08/09/2011 

Factor 

dB/m 

25.1 

24.8 

25.0 

25.1 

25.6 

25.5 

25.4 

25.5 

25.3 

25.0 

25.6 

25.4 

25.4 

25.4 

25.3 

25.1 

25.2 

25.3 

25.3 

26.2 

26.9 

28.2 

28.9 

28.0 

Frequency 

(MHz) 

2000.0 

2025.0 

2050.0 

2075.0 

2100.0 

2125.0 

2150.0 

2175.0 

2200.0 

2225.0 

2250.0 

2275.0 

2300.0 

2325.0 

2350.0 

2375.0 

2400.0 

2425.0 

2450.0 

2475.0 

2500.0 

Factor 

dB/m 

28.8 

28.5 

28.2 

29.1 

29.7 

28.8 

29.1 

28.0 

27.5 

27.0 

27.8 

27.1 

26.4 

26.4 

26.1 

26.7 

26.3 

26.9 

27.0 

26.9 

26.7 

Retlif Testing Laboratories 

Report No. R-1608P 

Page 95 of 95