COMPASS HEALTH TRUAIRE-5 User manual

TRUAIRE-5
5-LITER OXYGEN CONCENTRATOR
Manual
MODEL: O2C5L
Read this manual before operating the concentrator.
Save these instructions for future reference.

2
TABLE OF CONTENTS
Page
1. Introduction ............................................3
Intended Use
Contraindications
2. Safety Symbols and Denitions.............................3
3. Labeling Symbols and Descriptions .........................4
4. Safety Precautions and Warnings ...........................5
5. Illustration of Parts ......................................8
6. Technical Specications ..................................9
7. Getting Started ........................................10
Unpacking
Packing List
Inspection
Storage
8. Operating the Concentrator...............................10
Select a Location
Setting up the Concentrator
Flow Rate
O2 Sensor and Alarms
Turning off the Concentrator
9. Maintenance ..........................................12
Cleaning the Cabinet
Cleaning the Cabinet Filter
Replacing the Intake Filter
Cleaning the Humidier Bottle
Cleaning and Disinfection between Patients
10. Preventive Maintenance Log ..............................15
11. Troubleshooting Guide...................................16
12. EMC Information .......................................17
13. Limited Warranty .......................................21

3
INTRODUCTION
INTENDED USE
Thank you for purchasing the TruAire-5 by Roscoe Medical 5-Liter Oxygen
Concentrator. It is intended to provide low ow supplemental oxygen therapy
to a patient in the home, hospital or a healthcare facility. The device delivers
puried oxygen via oxygen mask or nasal cannula by separating nitrogen from
room air through a series of internal electronic functions. The patient is the
intended operator. Although the device can help to raise blood oxygen levels in
a patient, it is not intended to sustain or support life.
CONTRAINDICATIONS
There are no known contraindications.
SAFETY SYMBOLS AND PRECAUTIONS
DANGER
Indicates a potentially hazardous situation which, if not
avoided, could result in death or serious injury.
WARNING
Indicates a potentially hazardous situation which, if not
avoided, could result in serious injury or equipment damage.
CAUTION
Indicates a potentially hazardous situation which, if not
avoided, may result in minor or moderate injury to the user
or patient or damage to the device or other property.
IMPORTANT SAFETY PRECAUTIONS
AND WARNINGS
It is important that you read all warnings in user’s manual before use.
Use the product only for its intended use as described in the manual.
Improper use can result in serious or fatal illness / injury, improper
treatment or property damage. DO NOT attempt to operate this
product without reading all instructions carefully. Save this manual
for future reference.
WARNING
(USA only)
U.S. Federal Law restricts these devices to sale by, or on
the order of, a physician or licensed practitioner. This device
should only be used under the continued supervision of a
physician or licensed practitioner.
DANGER
THIS MEDICAL DEVICE IS NOT INTENDED TO BE USED AS
A LIFE SUSTAINING OR LIFE SUPPORTING DEVICE.

4
LABELING SYMBOLS AND DESCRIPTIONS

5
SAFETY PRECAUTIONS AND WARNINGS
WARNING
• Before use, check the ratings label on the back of the device to ensure that the voltage
and current indicated on the unit correspond with the voltage and current available.
DO NOT overload wall outlets or use with power strips or extension cords.
• DO NOT use this product with a DC to AC converter, or with any AC voltage and/or
frequency other than specied.
• NEVER operate this device if it has a damaged cord or plug, is not working properly
or any abnormalities occur, or has been exposed to any liquids inside or outside of the
housing. Contact your home care provider immediately.
• NEVER allow the power supply cord to be pulled, jerked, strained, twisted, or severely
bent, especially at the plug connections. Damage will occur at the high ex point of
entry into the appliance, causing it to rupture and short.
• DO NOT open or disassemble the compressor. Contact your home care provider for
any service or repair requests.
• DO NOT use the device if it is damaged in any way. Continued use of a damaged
device may cause injury to the patient or further damage to the device.
• Keep ALL electrical cords away from heated surfaces. DO NOT operate or store under
direct sunlight, high temperature or humidity. See technical specications for maximum
storage and operating temperatures and relative humidity
DISCONTINUE OPERATION IMMEDIATELY IF ANY OF THE MOTOR HOUSING PARTS
BECOME DETACHED OR BROKEN, EXPOSING THE MOTOR OR ANY OTHER
INTERNAL ELECTRICAL COMPONENTS.
• There is a risk of re associated with oxygen enrichment during oxygen therapy.
DO NOT use the oxygen concentrator or accessories near sparks or open ames.
DO NOT smoke while the oxygen concentrator is in use.
• Oxygen can make materials ammable. DO NOT leave the nasal cannula or mask on
bed coverings, clothing or chair cushions. Turn the oxygen concentrator OFF when
not in use.
• Keep the oxygen concentrator away from ammable and explosive areas.
• Patients who require continuous oxygen therapy should plan for alternate sources of
power in the event of a power failure. This device is NOT intended to be used as a life
sustaining or life supporting device.
• To avoid the risk of re and burns, NEVER use petroleum or oil-based lotions or salves
before or during oxygen therapy.
• DO NOT lubricate ttings, connections, tubing or other accessories of the device to
avoid the risk of re and burns.
• NEVER spray liquids onto the oxygen concentrator housing, especially near the display
panel or air vents. Fluid could cause damage to the electrical components and lead to
malfunction. If uid enters the unit, discontinue use immediately and return the product
to your home care provider.

6
• ALWAYS unplug immediately after each use and keep unplugged when not in use.
DO NOT run this product unattended.
• This device is to be used ONLY in accordance with the prescription of a physician and
this user manual. If at any time the patient or attendant determines insufcient oxygen
is being delivered, contact the provider and/or physician immediately. DO NOT make
adjustments to the ow rate UNLESS prescribed by a physician.
• Close supervision is necessary when this device is used by or near children and
physically or mentally impaired persons.
• If the electrical power source becomes unstable, discontinue use immediately and nd
an alternate power source.
• ONLY use stable and safe electrical power sources.
• NEVER block air openings of the oxygen concentrator or place it where the air
openings may be obstructed. Keep the openings free from lint, hair, dust, etc.
• ALWAYS place the oxygen concentrator at least 4 inches away from walls, draperies,
furniture, or similar surfaces. ALWAYS avoid deep pile carpets and heaters, radiators or
hot air registers.
• NEVER drop or insert any object into any opening.
• DO NOT place the device in a conned area.
• The oxygen concentrator MUST be kept away from heat, re, and excessive water
sources and conditions at ALL times.
• DO NOT place items on top of the oxygen concentrator.
• NEVER use the oxygen concentrator in the presence of pollutants or fumes. The air
intake and exhaust should be well-ventilated.
• DO NOT connect the oxygen concentrator in parallel or series with other oxygen
concentrators or oxygen therapy devices.
• ALWAYS keep oxygen concentrator at least 10 feet away from wireless communication
equipment such as wi- network devices, mobile phones, cordless phones and base
stations, walkie-talkies, etc.
• DO NOT bring the oxygen concentrator or accessories into a Magnetic Resonance
(MR) environment as it may cause unacceptable risk to the patient or damage to the
oxygen concentrator or MR medical devices.
• DO NOT use this device or accessories in an environment with electromagnetic equip-
ment such as CT scanners, Diathermy, RFID and electromagnetic security systems
(metal detectors) as it may cause unacceptable stable risk to the patient or damage
to the oxygen concentrator. Some electromagnetic sources may not be apparent; if
you notice any unexplained changes in the performance of this device, or it is making
unusual sounds, disconnect the power cord and discontinue use immediately. Contact
your home care provider.
• This device is suitable for use in home and healthcare environments EXCEPT for near
active HF surgical equipment and the RF shielded room of an ME system for magnetic
resonance imaging, where the intensity of electromagnetic disturbances is high.
• Portable RF communications equipment (including peripherals such as antenna cables
and external antennas) should be used no closer than 1 foot of the oxygen concentra-
tor, otherwise degradation of the equipment could result.

7
DANGER
• Smoking during oxygen therapy is dangerous and is likely to result in facial burns or
death. DO NOT allow smoking within the same room or vicinity of the oxygen
concentrator, or any oxygen carrying accessories.
• Open ames during oxygen therapy are dangerous and likely to result in re or death.
DO NOT allow open ames within 10 feet of the oxygen concentrator or any oxygen
carrying accessories.
• Users MUST NOT smoke while using this device. Keep ALL matches, lighted cigarettes
or other sources of ignition out of the room or vicinity of the device. NO SMOKING
signs should be prominently displayed. Textiles and other materials may easily ignite
and burn with greater intensity in oxygen enriched air. Failure to observe this warning
can result in severe re, property damage and cause physical injury or death.
• A spontaneous and violent ignition may occur if oil, grease or greasy substances come
in contact with oxygen under pressure. These substances MUST be kept away from
the oxygen concentrator, tubing and connections, and all other oxygen equipment at
ALL times.
• Avoid creation of any spark near the oxygen concentrator, including static electricity.
• Avoid use while bathing. If continuous usage is required under physician order, the
concentrator MUST be in another room at least 10 feet from the bath or shower.
• DO NOT come into contact with the concentrator while wet.
• DO NOT place or store the concentrator where it can drop into water or any
other liquid.
• DO NOT reach for product that has fallen into water. UNPLUG IMMEDIATELY and
contact your home care provider for examination and repair.
• Seek immediate medical assistance in the event of discomfort or a medical emergency
while undergoing oxygen therapy.
CAUTION
• Before use, check tubing and accessories for proper assembly. All parts should be
rmly in place. Use of improperly assembled tubing and accessories could diminish or
prevent adequate delivery of oxygen and the effectiveness of therapy.
• Tubing and accessories are for single patient use only. DO NOT share tubing and
accessories with other patients.
• DO NOT modify this device without authorization of the manufacturer.
• The oxygen concentrator should ALWAYS be kept in the upright position to
prevent damage.
• The oxygen concentrator cabinet should ONLY be opened by an authorized
repair center.
• DO NOT service or maintain this device while in use.

8
ILLUSTRATION OF PARTS
ITEM #O2C5L
Number Description
1Flowmeter
2Status Indicator Light
3Outlet Connector
4Circuit Breaker
5Power Switch
6Hour Meter
7Humidier Bottle Holder
8Power Cord
9Cabinet Filter
10 Intake Filter
11 Caster Wheels
12 Cabinet Housing
1
9
10
11 12
7
8
32
4
5
6

9
TECHNICAL SPECIFICATIONS
Electrical Requirements AC120V / 60 Hz
Rated Current Input 3.5A
Sound Level ≤50.5 dBA
Altitude
Up to 6000’ without degradation of
concentration levels
Atmospheric Pressure Range: 12.47 psi-15.37
psi (86 kPa-106 kPa)
Oxygen Concentration 93% (±3%) at 0.5~5L/min after warmup
period of 30 min.
Maximum Liter Flow 5L/min
Maximum Outlet Pressure 5.5 psi ±0.7 psi (35 kPa ± 5 kPa)
Low Flow Alarm 0.5-5 L/min
Filters Cabinet, Compressor Inlet, Final Bacteria
Product Dimensions 13”L x 10.25”W x 21.25”H
Product Weight 35.5 lbs
Operating Ambient Temperature and
Humidity
41°F-104°F (5°C-40°C),
≤80% RH
Storage and Transport Temperature
and Humidity
32°F-131°F (0°C-55°C)
10%-90% RH
Electrical Classication Class II equipment, Type BF applied part,
IP21
Mode of Operation Continuous
Minimum Operation Time 30 minutes
Safety System
Low Pressure Alarm
Low Oxygen Concentration Alarm
High Pressure/High Temperature Shutdown
Current Overload/Line Surge Shutdown
Maximum Cannula/Tubing Length 7’ Cannula + 50’ Oxygen Supply Tubing
Expected Life 6 Years
Warranty Period 3 Year Limited, 12,000 Hours on Parts
Software Version A1.0
Flow Range at Outlet Pressure of 0 psi 0.5-5L/min
Flow Range at Outlet Pressure of 1 psi 0.5-5L/min
Change in maximum recommended
ow when back pressure of 1 psi is
applied
<0.5L/min
CAUTION: Technical specications for
owmeter calibration by manufacturer and
tester. This device MUST be used according
to manufacturer instructions and physician’s
order. DO NOT adjust the device ow.

10
GETTING STARTED
UNPACKING
• Check for any obvious damage to the carton or its contents. If damage is
evident, please notify the delivery carrier or your home care provider.
• Remove all loose packing from the carton.
• Carefully remove the oxygen concentrator and all components from the carton.
NOTE: DO NOT dispose of the carton or packing materials. The oxygen concentrator
will be required to ship in its original packaging for warranty repair or return.
NOTE: Store the oxygen concentrator in its original packaging until use is required.
PACKING LIST
• Oxygen Concentrator
• Humidier Bottle
• User Manual
INSPECTION
• Examine exterior of the oxygen concentrator for any visible damage, including
nicks, dents, cracks, or scratches.
• Inspect all components, including accessories, display panel, power cord,
caster wheels, etc.
STORAGE
• Whenever the oxygen concentrator is not in use, place back in the original
packaging and store in a cool, dry area. DO NOT place anything on top of the
repackaged concentrator.
OPERATING THE CONCENTRATOR
SELECT A LOCATION
Select a room in your home where placement of the oxygen concentrator is
most convenient. Take into consideration the Safety Precautions & Warnings
detailed on pages 4-6 of this manual. The oxygen concentrator can be rolled
from room to room as needed.
SETTING UP THE CONCENTRATOR
Plug the oxygen concentrator power cord to an electrical outlet (see electrical
requirements in Technical Specications)

11
CONNECT HUMIDIFIER BOTTLE (IF PRESCRIBED)
• Remove cover from humidier bottle
• Fill humidier with puried or boiled (and cooled) tap water. DO NOT ll past
the maximum water level line.
WARNING: DO NOT ll humidier with boiling water
• Tighten the humidier bottle cover and secure in place by pulling the elastic
band at the front of the device and sliding the humidier bottle down toward
the humidier holder.
• Connect the humidier to the air outlet using humidier tubing.
• Connect the nasal cannula or oxygen mask tubing to the air outlet of the
humidier bottle.
• Press the power switch of the oxygen concentrator to the “on” position.
• After assembly, ensure oxygen ow through cannula or mask.
NOTE: Allow 30 minutes for the device to “warm up” to reach optimum oxygen
concentration. Concentrator may be used during the initial warm up time.
FLOWRATE
• Turn the owmeter knob to the setting prescribed by your physician.
NOTE: DO NOT set the ow above the red
line on the ow-meter. An oxygen ow
greater than 5 L/min will decrease the
oxygen concentration.
NOTE: If the ow rate on the owmeter
falls below 0.5 L/min, check tubing or
accessories for blocked or kinked tubing or
a defective humidier bottle.
Humidifier Safety Valve
Humidifier Cover
Humidifier Outlet
Humidifier Adapter
Humidifier Bottle
Filter Tube
Filter
Minimum
Maximum
5
4
3
2
1
0
5
4
3
2
1
0
min 0
Flowmeter magnitude sign
Flowmeter knob
Back floater
Flowmeter

12
O2SENSOR AND ALARMS
Indicator O2Purity Alarm Details
Green 82% ±2% No Normal operation, no action
needed.
Yellow 73%-82%
±2% No
Continue use and call provider
immediately. Ensure backup oxygen
source is nearby
Yellow N/A Intermittent
Compressor failure, low/high
pressure or low ow. Call provider
immediately.
Red <73% ±2% Intermittent Call provider and switch to backup
oxygen source immediately.
TURNING OFF THE CONCENTRATOR
Press power switch to the “off” position and unplug the concentrator from the
wall outlet.
MAINTENANCE
With proper care and maintenance, the TruAire-5 Oxygen Concentrator has an
expected service life of three years of operation when used in accordance with
the safety instructions, maintenance intervals and correct use stated in this
manual. The effective service life can vary according to frequency and duration
of use. Refer to the Preventive Maintenance Checklist in this manual for a
schedule of recommended maintenance.
WARNING: The oxygen concentrator regularly performs a self-check to
verify pressure and oxygen concentration. There is no need for calibration of
pressure or oxygen concentration. Annual maintenance is recommended for
optimal performance and should ONLY be performed by an authorized repair
center. DO NOT remove cabinet or attempt to make any repairs.

Compass Health Brands recommends use of original parts and lters for optimal
performance of the device.
CLEANING THE CABINET
Check the exterior housing of the oxygen concentrator monthly for visible dirt
or dust.
• Turn off the power switch and unplug the device.
• Using a damp cloth or sponge with a small amount of mild dish soap, gently
clean the exterior case.
• Allow the surface to air dry or use a clean, dry towel to wipe up dampness
before operating the concentrator.
WARNING
DO NOT use acetone, solvents or any other ammable products.
DO NOT spill liquid inside the cabinet
DO NOT use lubricants, oils or grease
DO NOT service or maintain while in use
DO NOT spray or apply any cleaning product directly to the cabinet
DO NOT hose down the product
CLEANING THE CABINET FILTER
• Turn off the power switch and unplug the device.
NOTE: Conditions in the home or facility may require more frequent inspection
and cleaning of the lter, including high dust, air pollutants, pet fur and
dander, etc.
• Carefully pull the cabinet lter from the side panel.
• Wash the lter in a solution of warm water and
mild dish soap.
• Rinse thoroughly with warm tap water and gently
squeeze excess water out. Allow to air dry or blow
dry completely before reinstalling.
WARNING: DO NOT operate the concentrator
without the lters installed, or if lters are wet.
Permanent damage to the concentrator could occur.

14
REPLACING THE INTAKE FILTER
WARNING: The intake lter CANNOT be
cleaned and should only be replaced.
NOTE: Intake lter replacement is recommended
every 2,000 hours. More frequent inspection and
replacement may be required depending on the
conditions of the home or facility.
• The intake lter is accessible from the cabinet lter
vent panel. Pull the cabinet lter panel from the
top tab to access the intake lter behind it.
• Reach inside and remove the intake lter.
• Dispose of the old intake lter and replace with
a new intake lter.
CLEANING THE HUMIDIFIER BOTTLE
NOTE: If using a humidier, change the water daily. Clean the humidier bottle
and cover at least weekly.
• Wash the humidier bottle and cover with warm water and mild dish soap,
then rinse thoroughly with warm running water and dry.
• To disinfect the humidier bottle and cover, soak in a solution of 1 part
vinegar diluted with 10 parts water. Rinse thoroughly with warm running
water and dry.
CAUTION: To limit risk of bacterial growth, clean the humidier and air
dry thoroughly when concentrator is not in use.
CLEANING AND DISINFECTION BETWEEN PATIENTS
WARNING: Cleaning and disinfection of the oxygen concentrator and
accessories between patients should ONLY be performed by qualied
personnel or an authorized repair center.
• Dispose of and replace all single patient accessories including:
o Nasal Cannula or Oxygen Mask and Supply Tubing
o Humidier
o Filters
• Perform maintenance procedures described in this manual and the Preventive
Maintenance Checklist.
• Check oxygen concentrator for any external damage that may require repair.
• Run checks to ensure the concentrator functions properly and all alarms are
in working order.
• Ensure contents of package include concentrator and user manual.

15
PREVENTATIVE MAINTENANCE LOG
Model: Serial Number:
EACH INSPECTION
Date of Service
Hour Meter
Readout
Clean Cabinet
Filter
Liter Flow
Prescription
PREVENTIVE MAINTENANCE/BETWEEN PATIENTS (Every 3 Years or
26,280 Hours)
Oxygen
Concentration
Replace
Cabinet Filter
Replace
Intake Filter
Check Power
Loss Alarm

16
TROUBLESHOOTING GUIDE
SYMPTOM PROBABLE
CAUSE SOLUTION NOTES
* Green and Yellow
lights on
* Continuous Alarm
* Concentrator
stops running
* Hour meter still
elapsing time
1. The valve plug
is loose
2. Exhaust sound
buffer box
jammed
3. Valve is blocked
4. Circuit board
failure
Check and connect
the valve plug to the
circuit board.
2. Replace part.
3. Replace part.
4. Replace part.
All repairs must be
completed by an
authorized repair
center
* Nasal Cannula
is fogging or has
water droplets
1. Improper venti-
lation is causing
elevated operat-
ing temperature
2. Compressor fan
is not running or
running slow
3. Water tempera-
ture in humidier
is too high
4. Water exceeds
max level in
humidier
1. Ensure device is
at least 4 inches
from walls, heat-
ers, or any other
obstructions.
2. Remove any
obstructions
blocking the fan,
or replace.
3. Add cold water
to the humidier
bottle.
4. Remove excess
water.
All repairs must be
completed by an
authorized repair
center
* Concentrator is
running, but yel-
low light is on
1. Oxygen concen-
tration is safe but
decreasing
2. Unit is over-
heating due to
blocked air intake
1. Clean or replace
lters.
2. Ensure device is
at least 4 inches
from walls, heat-
ers or any other
obstructions.
If issue persists,
contact home
care provider
immediately.
* Concentrator is
not running
* Red light is on
* Continuous audi-
ble alarm sounds
1. Low pressure
2. High pressure
1. Clean or replace
lters.
2. Contact equip-
ment provider
immediately.
If issue persists,
contact home
care provider
immediately.
* Concentrator is
not running
* Continuous audi-
ble alarm sounds
1. Compressor open
circuit alarm
2. Compressor short
circuit alarm
1. Contact equip-
ment provider
immediately
2. Contact equip-
ment provider
immediately
All repairs must be
completed by an
authorized repair
center

17
EMC INFORMATION
Guidance and manufacturer declaration – electromagnetic emissions for all
EQUIPMENT and SYSTEMS
Guidance and declaration of manufacturer -Electromagnetic emission
The O2C5L Ni Oxygen Concentrator is intended for use in an environment specied
below. The customer of the user of JMC5A Ni Oxygen Concentrator should assure that
the unit is used in such an environment.
Emission test Compliance Electromagnetic environment-
regulations
RF emissions CIS-
PR 11 Group 1
The O2C5L Ni Oxygen Concentrator uses
RF energy solely for its internal function.
Therefore, its RF emissions are very low
and are not likely to cause any interference
in nearby electronic equipment.
RF emissions CIS-
PR 11 Class B
The O2C5L Ni Oxygen Concentrator is
suitable for use in all establishments,
including domestic and those directly con-
nected to the public low- voltage power
supply network that supplies building used
for domestic purposes.
Emission of
harmonics IEC
61000-3-2 Class A
Voltage uctuations
/ icker emissions
IEC 61000-3-3
Complies

18
Guidance and manufacturer declaration – electromagnetic emissions for all
EQUIPMENT and SYSTEMS
Guidance and manufacturer’s declaration – electromagnetic immunity
The O2C5L Ni OXYGEN CONCENTRATOR is intended for use in the electromagnetic
environment specied below. The customer or the user of O2C5L Ni OXYGEN
CONCENTRATOR should assure that it is used in such an environment.
Immunity test IEC 60601 test
level Compliance level Electromagnetic environment - guidance
Electrostatic dis-
charge (ESD)
IEC 61000-4-2
±6 kV contact
±8 kV air
±6 kV contact
±8 kV air
Floors should be wood,
concrete or ceramic tile.
If oor are covered with
synthetic material, the rel-
ative humidity should be
at least 30%.
Electrical fast
transient/burst IEC
61000-4-4
±2 kV for power
supply lines
±2 kV for power
supply lines
Mains power quality
should be that of a typical
commercial or hospital
environment.
Surge
IEC 61000-4-5
±1 kV differen-
tial mode
±2 kV common
mode
±1 kV differential
mode
±2 kV common
mode
Mains power quality
should be that of a typical
commercial or hospital
environment.
Voltage dips,
short
interruptions and
voltage
variations on
power supply
input lines
IEC 61000-4-11
<5% UT
(>95% dip in
UT)
for 0.5 cycle
40% UT
(60% dip in UT)
for 5 cycles
70% UT
(30% dip in UT)
for 25 cycles
<5% UT
(>95% dip in
UT) for 5 sec
<5% UT
(>95% dip in UT)
for 0.5 cycle
40% UT
(60% dip in UT)
for 5 cycles
70% UT
(30% dip in UT)
for 25 cycles
<5% UT
(>95% dip in UT)
for 5 sec
Mains power quality
should be that of a typical
commercial or hospital
environment. If the user
of the O2C5L Ni OXYGEN
CONCENTRATOR
requires continued
operation during power
mains interruptions, it is
recommended that the
O2C5L Ni OXYGEN
CONCENTRATOR be
powered from an uninter-
ruptible power supply.
Power frequency
(50/60Hz)
magnetic eld
IEC 61000-4-8
3A/m 3A/m
Mains power quality
should be that of a typical
commercial or hospital
environment.
NOTE UT is the AC mains voltage prior to application of the test level.

19
Guidance and manufacturer declaration – electromagnetic immunity for
EQUIPMENT and SYSTEMS that are not LIFE-SUPPORTING
Guidance and declaration of manufacturer - Electromagnetic Immunity
For all Equipment and Systems that are not LIFE SUPPORTING
The Oxygen Concentrator is intended for use in the electromagnetic environment
specied below. The customer or the user of the Oxygen Concentrator should ensure
that the unit is used in such an environment.
Immunity
test
IEC 60601
test level
Compliance
level
Electromagnetic
environment - guidance
Conducted
RF IEC
61000-4-6
Radiated
RF IEC
61000-4-3
3 Vrms
150 kHz to
80 MHz
3 Vrms
80 MHz to
2.5 GHz
3 Vrms
3 V/m
Portable and mobile RF communications equip-
ment should be used no closer to any part of the
OXYGEN CONCENTRATOR, including cables,
than the recommended separation distance
calculated from the equation applicable to the
frequency of the transmitter.
Recommended separation distance
Where P the maximum output power rating of
the transmitter in watts (W) according to the
transmitter manufacturer and d is the recom-
mended separation distance in metres (m).
Field strengths from xed RF transmitters, as
determined by an electromagnetic site survey,a
should be less than the compliance level in each
frequency range.b
Interference may occur in the
vicinity of equipment marked
with the following symbol:
NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected
by absorption and reection from structures, objects and people.
a. Field strengths from xed transmitters, such as base stations for radio (cellular/cordless)
telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast
cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due
to xed RF transmitters, an electromagnetic site survey should be considered. If the measured
eld strength in the location in which the OXYGEN CONCENTRATOR is used exceeds the appli-
cable RF compliance level above, the OXYGEN CONCENTRATOR should be observed to verify
normal operation. If abnormal performance is observed, additional measures may be necessary,
such as reorienting or relocating the OXYGEN CONCENTRATOR.
b. Over the frequency range 150 kHz to 80 MHz, eld strengths should be less than 3 V/m.

20
Recommended separation distance between portable and mobile RF
communications equipment and the EQUIPMENT or SYSTEM for EQUIPMENT
or SYSTEM that are not LIFE-SUPPORTING
Recommended separation distances between portable and mobile RF
communications equipment and the Equipment and Systems that are
NOT LIFE SUPPORTING
The OXYGEN CONCENTRATOR is intended for use in an electromagnetic environment
in which radiated RF disturbances are controlled. The customer or the user of the OX-
YGEN CONCENTRATOR can help prevent electromagnetic interference by maintaining
a minimum distance between portable and mobile RF communications equipment
(transmitters) and the OXYGEN CONCENTRATOR as recommended below, according
to the maximum output power of
Rated maximum
output power of
transmitter
(W)
Separation distance according to frequency of transmitter (m)
150 kHz to 80 MHz 80 MHz to 800 mHz 800 MHz to 2.5 GHz
0.01 0.12 0.12 0.23
0.1 0.37 0.37 0.74
11.17 1.17 2.33
10 3.69 3.69 7.38
100 11.67 11.67 23.33
For transmitters rated at a maximum output power not listed above, the recommended separation
distance d in meters (m) can be estimated using the equation applicable to the frequency of the
transmitter, where P is the maximum output power rating of the transmitter in watts (W) according
to the transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected
by absorption and reection from structures, objects, and people.