C-Aire FreeStyle Comfort User manual

FreeStyle
®
Comfort
™
Technical Manual (English) MN233 B

2
FreeStyle Comfort
User Controls & System Status Indicator
ISO 7000: graphical symbols for use on
equipment –Index and synopsis
Read user’s manual before
operation Reg. #1641
Operating temperature
limitation of these units is 41°F
to 104°F (5°C to 40°C).
Storage temperature limitation
range is -25°C to 70°C (-13°F
to 158°F)
Humidity range is 10 to 95%.
Reg #2620
Atmospheric pressure
limitation. Reg. #2621
Name and address of
manufacturer. Reg. #3082
Date of manufacturer. Reg.
#2497
Catalog Number. Reg. #2493
Serial Number. Reg. #2498
This way up. Reg #0623
Fragile, handle with care. Reg.
#0621
Keep away from rain, keep dry.
Reg. #0626
Stacking limit by number. Reg.
# 2403
ISO 7010: Graphical symbols –Safety colors
and safety signs –Registered safety signs
The instruction manual must be
read. Reg. #M002
Do not smoke near unit or
while operating unit. Reg.
#P0002
Keep away from open flame,
fire, sparks. Open ignition
source and smoking prohibited.
Reg. # P003
Type BF applied part (degree
of protection against electric
shock) Reg. # 5333
Warning. Reg. #W001
Council Directive 93/42/EEC; concerning
medical devices
Authorized representative in
the European Community
This device complies with
the requirements of
Directive 93/42/EEC
concerning medical devices.
It bears the CE markings as
shown
IEC 60417
Class II Equipment, Double
Insulated Reg. #5172
Power Switch. Reg. # 5009
ETL Certification
Safety agency for
CAN/CSA C22.2 No.601.1
M90 for medical electrical
equipment
Internal Symbols
Keep away from
flammable materials, oils,
and grease
Do not Disassemble
Increase flow
Decrease flow
RTCA DO160 Section 21
Category M Compliant.
FAA SFAR 106
requirement
FAA Approved - POC
21 CFR 801.15: Code of Federal Regulations
Title 21
Federal law restricts this
device to sale by or on the
order of a physician
IEC 60601-1: Medical electrical equipment
Part 1 General requirements for basic safety
and essential performance
Drip proof

3
FreeStyle Comfort
Council Directive 2012/189/EU: waste
electrical and electronic equipment (WEEE)
WEEE
Contains FCC ID: WAP 2001
FCC Notice
FCC NOTICE:
This device may contain CYBLE-022001-00,
including the antenna 2450AT18B100 from
Johnson Technology, complies with par 15 of the
FCC rules. The device meets the requirements for
modular transmitter approval as detailed in FCC
public Notice DA00-1407. Transmitter operation
is subject to the following two conditions (1) This
device may not cause harmful interference, and (2)
This device must accept any interference received,
including interference that may cause undesired
operation.
This product may be covered by one or more
patents, US and international. Please visit our
website below for the listing of applicable patents.
Pat.: patents.gtls.io

4
FreeStyle Comfort
Table of Contents
User Controls & System Status Indicators...................................................................................................... 2
FreeStyle Comfort Overview.......................................................................................................................... 5
Description of Operation................................................................................................................................. 7
Safety Instructions........................................................................................................................................... 8
Specifications ................................................................................................................................................ 13
Test Procedures ............................................................................................................................................. 14
Patient Cleaning, Care & Routine Maintenance........................................................................................... 19
Equipment Provider Maintenance................................................................................................................. 21
Service Procedures........................................................................................................................................ 24
Alarm Conditions.......................................................................................................................................... 25
Troubleshooting............................................................................................................................................. 28
Troubleshooting Table .................................................................................................................................. 28
Accessories and Spare Parts List .................................................................................................................. 31
Notes.............................................................................................................................................................. 32

5
FreeStyle Comfort
FreeStyle Comfort Overview
Front View
Strap Attachment
User Interface
Air Outlet
Oxygen Outlet
Battery Pack
Air Intake/Filter
Battery Pack
Release Button
Power Port
Receptacle Tab
Decrease Setting
Power Button
Increase Setting
Display Screen

6
FreeStyle Comfort
Display Screen on Battery
Display Screen On AC/DC Power

7
FreeStyle Comfort
Description of Operation
The air we breathe contains approximately 21% oxygen, 78% nitrogen, and 1% other gasses. In the
FreeStyle Comfort, room air is drawn into the machine through the air intakes. It then passes through
an adsorbent material called molecular sieve. This material separates the oxygen from the nitrogen and
allows only the oxygen to pass through. The result is a flow of high-concentration oxygen delivered to
the user.
The FreeStyle Comfort combines advanced oxygen concentrator and oxygen conserving technologies
to create a portable device that allows for maximum portability and ambulation. The advanced pulse
flow delivery quickly senses when the user breathes in and delivers a pulse of oxygen at the beginning
of each inhalation. Pulse flow delivery is ideal for activities and time away from home. It conserves
oxygen and extends battery life as opposed to continuous flow. The FreeStyle Comfort is lightweight
enough to be carried via the handle, shoulder strap, or backpack. It can be operated on AC, DC (vehicle)
or battery power.

8
FreeStyle Comfort
Safety Instructions
Safety instructions are defined as
follows:
Indications for Use
Contraindications for Use
Safety Guidelines
WARNING: IMPORTANT SAFETY
INFORMATION FOR HAZARDS THAT
MIGHT CAUSE SERIOUS INJURY.
CAUTION: Important information for
preventing damaged to the FreeStyle
Comfort.
Note: Information needing special attention.
WARNING: IT IS VERY IMPORTANT TO
SELECT ONLY THE PRESCRIBED
LEVEL OF OXYGEN. DO NOT CHANGE
THE FLOW SELECTION UNLESS YOU
HAVE BEEN DIRECTED TO DO SO BY
A LICENSED CLINICIAN.
WARNING: FEDERAL (USA) LAW RESTRICTS
THIS DEVICE TO SALE OR RENTAL BY ORDER
OF A PHYSICIAN OR OTHER LICENSED HEALTH
CARE PROVIDER.
WARNING: THIS UNIT IS NOT TO BE USED FOR
LIFE SUPPORT. GERIATRIC, PEDIATRIC, OR
ANY OTHER USER UNABLE TO COMMUNICATE
DISCOMFORT WHILE USING THIS DEVICE MAY
REQUIRE ADDITIONAL MONITORING. USERS
WITH HEARING AND/OR SIGHT IMPAIRMENT(S)
MAY NEED ASSISTANCE WITH MONITORING
ALARMS.
WARNING: PULSE DOSE MODE SETTINGS
MUST BE DETERMINED FOR EACH USER
INDIVIDUALLY FOR THEIR NEEDS AT REST,
DURING EXERCISE, AND WHEN TRAVELING.
WARNING: SOME RESPIRATORY EFFORTS OF
THE PATIENT MIGHT NOT TRIGGER THE
CONVERSERING FUNCTION WARNING: THE
FREESTYLE COMFORT IS NOT INTENDED FOR
USE WITH A TRACHEOTOMISED PATIENT
WARNING: PREGNANT OR NURSING WOMEN
SHOULD NOT USE ACCESSORIES
RECOMMENDED IN THIS MANUAL, THEY MAY
CONTAIN PHTHALATES.
WARNING: IN CERTAIN CIRCUM-
STANCES, THE USE OF NON-PRE-
SCRIBED OXYGEN CAN BE HAZARD-
OUS. THIS DEVICE SHOULD ONLY BE
USED WHEN PRESCRIBED BY A
PHYSICIAN.
WARNING: NOT FOR USE IN THE PRESENCE OF
FLAMMABLE ANESTHETICS.
WARNING: AS WITH ANY ELECTRICALLY
POWERED DEVICE, THE USER MAY
EXPERIENCE PERIODS OF NON-OPERATION AS
A RESULT OF ELECTRICAL POWER
INTERRUPTION, OR THE NEED TO HAVE THE
OXYGEN CONCENTRATOR SERVICED BY A
QUALIFIED TECHNICIAN. THE OXYGEN
CONCENTRATOR IS NOT APPROPRIATE FOR
ANY USER WHO WOULD EXPERIENCE AD-
VERSE HEALTH CONSEQUENCES AS THE
RESULT OF SUCH TEMPORARY
INTERRUPTION.
WARNING: NO MODIFICATION OF
THIS EQUIPMENT IS PERMITTED
WARNING: THIS DEVICE SUPPLIES HIGH-CON-
CENTRATION OXYGEN THAT PROMOTES RAPID
BURNING. DO NOT ALLOW SMOKING OR OPEN
FLAMES WITHIN THE SAME ROOM OF (1) THIS
DEVICE, OR (2) ANY OXYGEN-CARRYING
ACCES- SORY. FAILURE TO OBSERVE THIS
WARNING CAN RESULT IN SEVERE FIRE,
PROPERTY DAMAGE, AND/OR CAUSE
PHYSICAL INJURY OR DEATH.
WARNING: DO NOT OPERATE UNIT IN A RE-
STRICTED OR CONFINED SPACE (I.E., A SMALL
CASE OR HANDBAG) WHERE VENTILATION
CAN BE LIMITED. THIS CAN CAUSE THE
OXYGEN CONCENTRATOR TO OVERHEAT AND
IMPAIR PERFORMANCE.
WARNING: THE CONCENTRATOR SHOULD BE
LOCATED AS TO AVOID SMOKE, POLLUTANTS
OR FUMES.

9
FreeStyle Comfort
WARNING: THE USE OF SOME OXY-
GEN ADMINISTRATING ACCESSORIES
NOT SPECIFIED FOR THIS OXYGEN
PERFORMANCE. RECOMMENDED AC-
CESSORIES ARE REFERENCED
WITHIN THIS MANUAL.
WARNING: IF THE OXYGEN CONCENTRATOR
HAS BEEN DROPPED, DAMAGED OR EXPOSED
TO WATER, PLEASE CONTACT YOUR HOME
CARE PROVIDER FOR INSPECTION OR POSSIBLE
RE- PAIR OF THE DEVICE. DO NOT USE THE
OXYGEN CONCENTRATOR IF IT HAS A DAMAGED
POWER CORD OR PLUG.
WARNING: PROPERLY SECURE, BELT OR
OTHER- WISE RESTRAIN THE OXYGEN
CONCENTRATOR WHEN IN A VEHICLE DURING
TRANSPORT TO PREVENT DAMAGE OR INJURY.
WARNING: THE US DEPARTMENT OF TRANS-
PORTATION (DOT) AND UNITED NATIONS (UN)
REGULATIONS REQUIRE THE REMOVAL OF THE
BATTERY FROM THE DEVICE FOR ALL INTERNA-
TIONAL AIRLINE TRAVEL WHEN THE OXYGEN
CONCENTRATOR IS CHECKED AS LUGGAGE.
WHEN SHIPPING THE OXYGEN CONCENTRATOR,
THE BATTERY MUST ALSO BE REMOVED FROM
THE DEVICE AND PACKAGED PROPERLY.
WARNING: DO NOT OPERATE THIS EQUIPMENT
WITHOUT FIRST READING AND UNDERSTAND-
ING THIS MANUAL. IF YOU ARE UNABLE TO
UNDERSTAND THE WARNINGS AND INSTRUC-
TIONS, CONTACT YOUR EQUIPMENT PROVIDER
BEFORE ATTEMPTING TO USE THIS EQUIPMENT;
OTHERWISE, INJURY OR DAMAGE MAY RESULT.
WARNING: IF YOU FEEL DISCOMFORT OR ARE
EXPERIENCING A MEDICAL EMERGENCY, SEEK
MEDICAL ASSISTANCE IMMEDIATELY.
WARNING: OPERATING THE OXYGEN CON-
CENTRATOR OUTSIDE OF THE OPERATIONAL
TEMPERATURE SPECIFICATIONS CAN LIMIT THE
CONCENTRATOR’S ABILITY TO MEET OXYGEN
CONCENTRATION SPECIFICATION. REFER TO
THE SPECIFICATION SECTION OF THIS MANUAL
FOR TEMPERATURE LIMITS.
WARNING: USE NO OIL, GREASE, OR PETRO-
LEUM-BASED OR OTHER FLAMMABLE PROD-
UCTS WITH THE OXYGEN-CARRYING ACCESSO-
RIES OR THE OXYGEN CONCENTRATOR. ONLY
WATER BASED, OXYGEN COMPATIBLE
LOTIONS OR SALVES SHOULD BE USED.
OXYGEN ACCEL- ERATES THE COMBUSTION OF
FLAMMABLE SUBSTANCES.
WARNING: DO NOT ALLOW EITHER THE AIR
INTAKE OR THE AIR OUTLET EXHAUST TO
BECOME BLOCKED. DO NOT DROP OR INSERT
ANY OBJECTS INTO ANY OPENINGS ON THE
DEVICE. THIS CAN CAUSE THE OXYGEN
CONCENTRATOR TO OVERHEAT AND IMPAIR
PERFORMANCE.
WARNING: THE INCORRECT USE OF THE
BATTERY CAN CAUSE THE BATTERY TO GET
HOT, IGNITE, AND MAY CAUSE SERIOUS
INJURY. BE SURE NOT TO PIERCE, STRIKE,
STEP ON, DROP THE BATTERY, OR OTHERWISE
SUBJECT THE BATTERY TO STRONG IMPACTS
OR SHOCKS. THE USE OF A DAMAGED
BATTERY MAY CAUSE PERSONAL INJURY.
WARNING: DO NOT SHORT-CIRCUIT THE
BATTERY’S METAL CONTACTS WITH METALLIC
OBJECTS, SUCH AS KEYS OR COINS. THIS MAY
CAUSE SPARKS OR EXCESSIVE HEAT TO BE
GENERATED.
WARNING: WHILE USING THE PORTABLE
OXYGEN CONCENTRATOR OUTDOORS WITH
THE AC POWER SUPPLY, CONNECT THE POWER
SUPPLY INTO A GROUND FAULT INTERRUPTED
(GFI) OUTLET ONLY.
WARNING: THE OXYGEN CONCENTRATOR
SHOULD NOT BE USED ADJACENT TO OR
STACKED WITH OTHER EQUIPMENT. IF
ADJACENT OR STACKED USE IS UNAVOIDABLE,
THE DEVICE SHOULD BE OBSERVED TO VERIFY
NORMAL OPERATION.
WARNING: USE OF CABLES AND ADAPTERS
OTHER THAN THOSE SPECIFIED, WITH THE
EXCEPTION OF CABLES AND ADAPTERS SOLD
BY THE MANUFACTURER OF THE MEDICAL
ELECTRICAL EQUIPMENT AS REPLACEMENT
PARTS FOR INTERNAL COMPONENTS, MAY
RESULT IN INCREASED EMISSIONS OF
DECREASED IMMU- NITY OF THE OXYGEN
CONCENTRATOR.
WARNING: USE ONLY ELECTRICAL VOLTAGE
SPECIFIED ON THE SPECIFICATION LABEL AF-
FIXED TO THE DEVICE.

10
FreeStyle Comfort
WARNING: DO NOT USE EXTENSION CORDS
WITH THIS UNIT OR CONNECT TOO MANY PLUGS
INTO THE SAME ELECTRICAL OUTLET. THE USE
OF EXTENSION CORDS COULD ADVERSELY
AFFECT THE PERFORMANCE OF THE DEVICE.
TOO MANY PLUGS INTO ONE OUTLET CAN
RESULT IN AN OVERLOAD TO THE ELECTRICAL
PANEL CAUSING THE BREAKER/FUSE TO
ACTIVATE OR FIRE IF THE BREAKER OR FUSE
FAILS TO OPERATE.
CAUTION: In the event of an alarm or
you observe the Oxygen Concentrator is
not working properly; consult the
Troubleshooting section in this manual.
If you cannot resolve the problem,
consult your Equipment Provider.
CAUTION: To prevent a void warranty, follow all
manufacturer’s instructions.
WARNING: DO NOT ATTEMPT ANY
MAINTENANCE OTHER THAN THE
POSSIBLE SOLUTIONS LISTED WITHIN
THIS MANUAL. DO NOT REMOVE
COVERS, ONLY YOUR EQUIPMENT
PROVIDER OR A QUALIFIED SERVICE
TECHNICIAN SHOULD REMOVE THE
COVERS OR SERVICE THIS DEVICE.
WARNING: ONLY ACCESSORIES RECOMMENDED
BY THE MANUFACTURER. USE OF ANY OTHER
MAY BE HAZARDOUS, CAUSE SERIOUS DAMAGE
TO YOUR OXYGEN CONCENTRATOR AND WILL
VOID THE WARRANTY.
WARNING: THE MANUFACTURER RECOMMENDS
AN ALTERNATE SOURCE OF SUPPLEMENTAL
OXYGEN IN THE EVENT OF A POWER OUTAGE,
ALARM CONDITION, OR MECHANICAL FAILURE.
CONSULT YOUR PHYSICIAN OR EQUIPMENT
PROVIDER FOR THE TYPE OF RESERVE SYSTEM
REQUIRED.
WARNING: SMOKING WHILE USING OXYGEN IS
THE NUMBER ONE CAUSE OF FIRE INJURIES
AND RELATED DEATHS. YOU MUST FOLLOW
THESE SAFETY WARNINGS:
WARNING: DO NOT ALLOW SMOKING, CAN-
DLES, OR OPEN FLAMES IN THE SAME ROOM
WITH THE DEVICE OR THE OXYGEN-CARRYING
ACCESSORIES.
WARNING: SMOKING WHILE WEARING AN
OXYGEN CANNULA MAY CAUSE FACIAL BURNS
AND POSSIBLY DEATH.
WARNING: IF YOU SMOKE, THESE 3 STEPS MAY
SAVE YOUR LIFE: TURN OFF THE OXYGEN
CONCENTRATOR, TAKE OFF THE CANNULA,
AND LEAVE THE ROOM WHERE THIS DEVICE IS
LOCATED.
WARNING: “NO SMOKING – OXYGEN IN USE”
SIGNS MUST BE PROMINENTLY DISPLAYED
IN THE HOME, OR WHERE OXYGEN IS IN USE.
USERS AND THEIR CAREGIVERS MUST BE IN-
FORMED ABOUT THE DANGERS OF SMOKING IN
THE PRESENCE OF, OR WHILE USING, MEDICAL
OXYGEN.
WARNING: DO NOT USE YOUR OXYGEN CON-
CENTRATOR IN THE PRESENCE OF FLAMMABLE
GASES. THIS CAN RESULT IN RAPID BURNING
CAUSING PROPERTY DAMAGE, BODILY
INJURIES OR DEATH.
WARNING: REMOVING THE CANNULA AND
PUTTING IT ON CLOTHING, BEDDING, SOFAS,
OR OTHER CUSHION MATERIAL WILL CAUSE A
FLASH FIRE WHEN EXPOSED TO A CIGARETTE,
HEAT SOURCE, OR FLAME.
WARNING: DO NOT LEAVE A NASAL CANNULA
ON OR UNDER CLOTHING, BED COVERINGS OR
CHAIR CUSHIONS. IF THE UNIT IS TURNED ON
BUT NOT IN USE, THE OXYGEN WILL MAKE THE
MATERIAL FLAMMABLE. ENSURE THE POWER IS
OFF WHEN THE OXYGEN CONCENTRATOR IS
NOT IN USE.
WARNING: THE OXYGEN CONCENTRATOR MUST
BE OFF AND DISCONNECTED FROM EXTERNAL
POWER BEFORE REMOVING THE BATTERY
PACK.
CAUTION: Always disconnect AC power
supply from the wall before
disconnecting the AC power supply from
the Oxygen Concentrator.
CAUTION: Do not position the Oxygen
Concentrator so that it is difficult to access the
power cord.
CAUTION: Always place oxygen supply tubing and
power cords in a manner that prevents trip hazard
or possible accidental strangulation.

11
FreeStyle Comfort
WARNING: SMALL PARTS MAY
HAZARD.
WARNING: AVOID CONTACT, LONGER THAN 10
SECONDS, WITH EXHAUSR VENT AS IT MAY BE
WARM.
WARNING: WIND OR STRONG DRAUGHTS CAN
ADVERSELY AFFECT ACCURATE DELIVERY OF
OXYGEN THERAPY.
CAUTION: When using the Oxygen Concentrator in
an automobile, boat, or on other DC sources with
the DC power supply, make sure that the vehicle is
started and running before connecting the Oxygen
Concentrator. If the DC power supply does not
illuminate and requires resetting, disconnect the
DC power supply from the DC outlet, restart your
vehicle, and then reconnect your DC power supply
into the DC outlet. Failure to follow these
instructions can result in the power supply not
supplying power to the Oxygen Concentrator.
CAUTION: When the automobile in which you are
using the Oxygen Concentrator unit is turned off,
disconnect and remove the device from the
automobile. Do not store the Oxygen Concentrator
in a very hot or cold automobile or in other similar,
high- or low-temperature environments.
Note: Portable and mobile RF communications
equipment can affect medical electrical equipment.
CAUTION: DO NOT leave the Oxygen
Concentrator or the Power Supply
plugged into the vehicle if the ignition is
in the OFF position. Doing so may drain
the vehicle’s battery.
CAUTION: For Oxygen Concentrators equipped
with batteries: Store in a cool and dry location to
help ensure the longevity of your battery. Storing
your Oxygen Concentrator for extended periods of
time at high temperatures or with a fully charged or
completely discharged battery can degrade its
overall battery life.
Do not attempt to open the battery; there are no
serviceable parts inside the battery. Keep
batteries away from children.
CAUTION: ONLY USE the Manufacturer’s provided
batteries. For proper battery disposal, contact
your Equipment Provider or your local
government agency for disposal requirements.
CAUTION: Operating or storing the Oxygen
Concentrator Outside of its normal operating
temperature range and ambient pressure range
(altitude) can affect performance and decrease
battery run time and/or increase battery charge
time.
Refer to the Specifications section in this manual
for storage and operating temperature limits.
Note: Ensure the cannula is fully inserted and
secure. This ensures that the Oxygen Concentrator
can properly detect inspiration for oxygen delivery.
During inhalation, you should hear or feel oxygen
flow to the prongs of the nasal cannula.
Note: Lithium batteries may permanently lose
capacity when exposed to extremely hot
temperatures with the batteries fully charged or
completely depleted. For extended storage, it is
recommended that batteries be charged 25 to 50%
and remain within a temperature range of 73°F ±
35°F (23°C ± 2°C).
Note: The use of some oxygen administration
accessories not specified for use with this oxygen
concentrator may impair its performance.
Recommended accessories are referenced within
this manual.
Note: Do not operate the Oxygen Concentrator
without the air intake filter in place. If a second
filter is provided, insert the replacement filter
before you clean the dirty filter. Clean the dirty
filter in a warm soap and water solution, then dry
thoroughly prior to use.
Note: The Manufacturer does not recommend the
sterilization of this equipment.
Note: There is never a danger of depleting the
oxygen in a room when you use your oxygen
concentrator unit.
WARNING: THE OXYGEN CONCEN-
TRATOR SHOULD NOT BE OPERATED
OR PLUGGED IN TO EXTERNAL (AC/
DC) POWER WITHOUT A BATTERY
INSTALLED. DO NOT ATTEMPT TO
POWER ON THE UNIT OR CONNECT IT
TO EXTERNAL POWER WHEN THE
BATTERY PACK IS REMOVED.

12
FreeStyle Comfort
ONLY REMOVE THE BATTERY PACK WHEN THE
UNIT IS POWERED OFF AND UNPLUGGED FROM
THE POWER SUPPLY. DO NOT ATTEMPT TO
REMOVE THE BATTERY PACK WHILE THE UNIT
IS STILL ON OR PLUGGED INTO THE POWER
SUPPLY.
Note: If the oxygen concentrator has been stored
for an extended period of time outside of its
normal environmental operating conditions shown
in the table above, it should be allowed to return
to normal operating temperature before being
powered on.

13
FreeStyle Comfort
Specifications
FreeStyle Comfort
Dimensions (with Single Battery)
10.0 x 7.3 x 3.1 in (25.4 x 18.5 x 7.9 cm)
Dimensions (with Double Battery)
11.0 x 7.3 x 3.1 in (27.9 x 18.5 x 7.9 cm)
Weight (with Single Battery Pack)
5 lbs. (2.3kg)
Weight (with Double Battery Pack)
6 lbs. (2.7kg)
Nominal Sound Level
43 dbA @ 2
Flow Settings
Pulse Setting 1, 2, 3, 4, 5
O2 Output Setting
Setting 1 - 210 mL/min
Setting 2 - 420 mL/min
Setting 3 - 630 mL/min
Setting 4 - 840 mL/min
Setting 5 - 1050 mL/min
Oxygen Concentration*
90% (+5.5% / -3%)
Oxygen Monitor
Yes
Maximum Outlet Pressure
< 30PSI
Dosing Sensitivity
< 0.5 cmH2O
Length of Cannula
7 ft. (2.1 m)
AC Power
100-240VAC, 50-60Hz
DC Power
11-18 VDC (10 max amp)
Battery Re-Charge Time
Single Battery: 3.5 hours
Double Battery: 6.0 hours
Battery Pack Durations
Single Battery Duration: Setting 2 - up to 4 hours
Double Battery Duration: Setting 2 - up to 8 hours
Operating Temperature**
41°F to 104°F (5°C to 40°C)
Transportation and Storage Temp.
(Unit)
-13°F to +158°F (-25°C to +70°C) up to 10,000 ft. (3048m)
Transportation and Storage Temp.
(Battery)
-13°F to +158°F (-25°C to +70°C) up to 10,000 ft. (3048m)
Operating Altitude**
-1250 to 10,000 ft. (-381 to 3048 m) (tested to 700-1060 hPa)
Operating Humidity
15-95% relative humidity (non-condensing)
Limited Warranty
3 years unit
1 year battery & power supplies
* Based on an atmospheric pressure of 14.7 psi (101 kPa) at 70°F (21°C)
**Operating outside of these operational specifications can limit the concentrator’s ability to meet Oxygen
Concentration specification at higher liter flow rates. The warm-up screen may continue to display until the
concentrator has reached target concentration or up to 15 minutes. Continue to use the unit during this time.
The expected service life is a minimum of five years. The expected shelf life of the sieve beds is approximately one
year if concentrator us unused during the entire peri

14
FreeStyle Comfort
Test procedures
VERIFY GENERAL OPERATION
1. Locate and position the FreeStyle
Comfort in a proper location for use.
a. The concentrator should be well-
ventilated so that the air intake filters
and air outlet are not obstructed.
b. The concentrator should be positioned
so that all audible and visual indicators
and alarms can be easily seen and heard.
c. Be sure the air intake filters are in place
before operating the unit. If the unit is
missing a filter, contact your equipment
provider.
2. Install a Battery Pack in the concentrator
a) Align the battery with the bottom
housing from the center of the FreeStyle
Comfort.
b) Slide the battery inward until you hear a
click to confirm that it has locked in
place.
3. Insert the AC or DC power supply into the
power port receptacle on the front, bottom
right side of the unit.
4. Connect a nasal cannula to the oxygen
outlet barb. Ensure the connection is secure
before the operation.
5. Turn on the FreeStyle Comfort by pressing
the power button and select your
prescribed flow setting utilizing the
increase (+) or decrease (-) flow buttons.
A brief audible alarm will sound to indicate the
device has powered on. A start-up screen will
appear showing the current firmware revision in
the bottom right corner.
NOTE: Any Cannula(s) used other than the
recommended may affect performance.

15
FreeStyle Comfort
Next, the warm-up screen will display while the
oxygen concentration is increased until it
exceeds low concentration threshold or up to 15
minutes whichever is sooner. Also, the FreeStyle
Comfort will start by auto-dosing until a breath
is detected or warmup ends, whichever is sooner.
6. Position the nasal cannula on your face
per the manufacturer’s instructions
provided with the cannula and breathe
normally. Youshould feel a puff of
oxygen delivered through the nasal
cannula each time you inhale.
7. To change the flow setting, press the
increase(+) or decrease (-) flow buttons
to the desired flow rate. It is normal to
hear a difference in sound as you change
the flowsettings.
8. Turn the FreeStyle Comfort off by
pressing the power button.
Pulse Volume (mL)*
Setting
Breath
Rate
1
2
3
4
5
15
14
28
42
56
70
20
10.5
21
31.5
42
52.5
25
8.4
16.8
25.2
33.6
42
30
7
14
21
28
35
35
6
12
18
24
30
40
5.3
10.5
15.8
21
26.3
Tolerance is +/- 15%
Note: When the Freestyle Comfort is initially
turned on the default flow setting is 2. If the
setting is changed, the unit will power on to the
previous flow setting.
Note: The display screen will enter standby
mode and dim after 20 seconds. Press any
button to wake the screen out of standby mode.
Note: To Equipment Provider: the following
oxygen administration accessories are
recommended for use with the oxygen
concentrator:
•Nasal Cannula with 7ft (2.1m) of tubing:
PN 5408-SEQ (1 to 6LPM)
•For any additional recommended
accessories, please see the accessories
Catalog (PN: ML-LOX0010) available on
www.CAIREmedical.com.
•A firebreak is required for use with any
cannula
•Caire offers the OxySafeTM. This is
intended to be used in conjunction with
the oxygen concentrator. The OxySafeTM
is a thermal fuse to stop the flow of gas in
the event that the downstream cannula or
oxygen tubing between the patient and
the oxygen outlet of the FreeStyle
Comfort. For Proper use of the
OxySafeTM, always refer to the
manufacturer’s instructions (included
with each OxySafe kit). CAIRE offers an
OxySafeTM kit that includes a cannula
headpiece, OxySafeTM, and 7’ tubing: PN:
20629671.

16
FreeStyle Comfort
Test Mode Operation and O2
Concentration Check
Entering Test Mode
With the unit turned on, press the following
sequence of buttons “+ + - - + - + -”. For the unit
to recognize the following sequence, it has to be
entered within a 5 second period. If the sequence
of buttons is entered correctly, the unit will alarm
and the screen will change, having a red border
around the screen, indicating the unit is now in
test mode. The unit will begin auto-pulsing,
enabling O2 concentration testing.
To exit test mode, turn off the unit or re-enter the
test mode sequence. Be sure to exit test mode
before returning the unit to patient use.
Hour Meter
The hour meter will be useful for tracking the
usage of the unit and plan the provider
maintenance:
1. To view the total operating hours, turn
the unit on and enter Test Mode per the
instruction from the previous section.
2. Within the Test Mode, the five-digit
number shown at the bottom of the screen
(next to the hourglass symbol) is the
operating hours of the unit
Alarm Code in Test Mode
Reviewing the Alarm Code may be useful during
the troubleshooting. The unit will enter an auto-
pulse mode for testing such as oxygen level:
1. To check the Alarm Code, turn the unit
on and enter the Test Mode per instruct
from the previous section.
2. On the top of the screen, the four-digit
number indicates the operating status of
the unit. Any combination beside 0000
will indicate the specific issue of the unit.
Refer to TROUBLESHOOTING IN
TEST MODE for details.
O2 CONCENTRATION TEST
Before reviewing the Troubleshooting Chart, the
following steps may be useful to identify any
malfunctions:
1. Make sure all filters are clean.
2. Enter the Test Mode per instruct from the
previous section. After ten minutes of
running in test mode, measure the oxygen
concentration. The acceptable O2 range is
90% oxygen+5.5/-3%.
Note: The pulse setting can be increased
or decreased as normal operation while in
test mode.
3. To exit test mode, turn off the unit or re-
enter the test mode sequence. Be sure to
exit test mode before returning the unit to
patient use.
VERIFY AC AND DC OPERATION
The FreeStyle Comfort comes with an AC and
DC power supply to keep your concentrator
powered wherever you go.
The AC power supply includes the following:
a. AC Power brick that operates between
100-240 volts, 50-60Hz.
b. AC Power cord to connect to the power
brick and corresponding AC outlet.
The DC power supply consists of a cord that
plugs directly into the unit and the DC outlet.

17
FreeStyle Comfort
VERIFY AC POWER OPERATION
AC power is for use at home or wherever standard
AC outlet power is available. The FreeStyle
Comfort is fully functional on AC power. The
FreeStyle Comfort will also recharge the battery
pack if needed any time AC power is available
(except in an airplane). Thebattery pack will
recharge whether the FreeStyle Comfort is
powered on or off.
To connect the FreeStyle Comfort to AC Power:
1. Connect the AC power brick to the power
connector inlet on the front, right bottom of
the FreeStyle Comfort. Be sure to push
inward, so the connection is secure.
2. Connect the AC power cord to the AC
power brick.
3. Connect the opposite end of the AC power
cord to the wall or another appropriate
electrical outlet.
4. Connect the AC power brick to the power
connector inlet on the front, right bottom
of the FreeStyle Comfort. Be sure to push
inward so that the connection is secure.
5. Turn on the FreeStyle Comfort by pressing
the power button and increase (+) or
decrease (-) the pulse setting.
6. Verify unit operates properly in all
settings.
VERIFY DC POWER
DC power is for use in the accessory outlets of
automobiles, boat, or other motor vehicles. The
FreeStyle Comfort is fully functional for use on
DC power. The FreeStyle Comfort will also
recharge the battery pack if needed any time DC
power is available. The battery pack will recharge
both if the unit is off, or on and in use.
1. Turn on your motor vehicle.
WARNING: DO NOT CONNECT EX-
TERNAL POWER WITHOUT A
BATTERY PACK INSTALLED IN THE
OXYGEN CONCENTRATOR.
Note:Ifthebatterypackneedstoberecharged,
thebatteryicononthedisplaywillhaveasingle
orange bar.
WARNING: DO NOT CONNECT EX-
TERNAL POWER WITHOUT A BATTERY
PACK INSTALLED IN THE OXYGEN
CONCERTRATOR.
Note:Never operate the unit without the
vehicle running.

18
FreeStyle Comfort
2. Connect the DC power supply to the power
port receptacle front, bottom right side of the
FreeStyle Comfort. Be sure to push inward so that
the connection is secure.
3. Connect the opposite end of the DC power cord
to the automobile or other DC accessory outlet.
4. Turn on the FreeStyle Comfort by pressingthe
power button and select your prescribed flow
setting utilizing the increase (+) or decrease (-)
flowbuttons.
5. Verify that unit operates properly in all
settings.
VERIFY AIRPLANE MODE
The FreeStyle Comfort can be used on an aircraft
per normal operating procedures using battery
power ONLY, with no external power source is
connected. If an electrical outlet is available,
operable, and its location is appropriate for use as
a power source, it may serve as a back up to the
FreeStyle Comfort’s Batteries. In this case, the
following recommended procedure regarding the
transition from battery to aircraft electrical power
must be followed:
1. Turn the FreeStyle Comfort On using
battery power ONLY, with no external
power source connected.
2. Enable airplane mode by press and hold
both Up and Down buttons for 5 seconds
until you hear a long beep and see the
airplane symbol appear as indicated below.
3. When the airplane symbol is displayed,
you can plug in the Freestyle Comfort.
Note: Due to aircraft limitations, the
batteries do not charge in Airplane Mode.
Note:Ifthebatterypackneedstoberecharged,
thebatteryicononthedisplaywillhaveasingle
orange bar.

19
FreeStyle Comfort
Patient Cleaning, Care &
Routine Maintenance
ROUTINE MAINTENANCE
Servicing of internal components inside of the
cabinet of the FreeStyle Comfort must be
performed by the oxygen provider.
The operator of the unit is responsible for the
following maintenance procedures.
•Weekly –Clean the Air IntakeFilters
AIR INTAKE FILTERS
Air enters the FreeStyle Comfort through air intake
filters located on the front, bottom of the oxygen
concentrator. These filters prevent dust and other
large particles in the air from entering the unit.
At least once per week, the air intake filters should
be cleaned. Your oxygen provider may advise you
to clean them more frequently, depending upon the
operating conditions. Follow these steps to clean
the air intake filters properly.
1. Remove the filters from the front of the
FreeStyle Comfort by pushing up on the
corresponding tab and pulling outward.
2. Wash the filters in a warm solution of soapand
water.
3. Rinse the filters thoroughly and remove excess
water with a soft, lint-free cloth. Ensure thefilters
are completely dry before reattaching.
4. Re-install the clean, dry filters.
BATTERY PACK CARE
Do not allow the battery pack to be exposed to
liquids.
Do not attempt to disassemble or open the battery
pack.
Do not expose the battery to open flames. Do not
drop the battery pack.
Keep the battery pack away from children.
If your battery pack appears damaged, contact
your oxygen provide before use.
Do not place the battery in or near a microwave or
other cooking appliances.
BATTERY PACK DURATION
Setting
Single (8-cell)
Battery Duration
Double (16-cell)
Battery Duration
1
Up to 8 hours
16 hours
2
Up to 4.25 hours
8.50 hours
3
Up to 3 hours
6 hours
4
Up to 2.25 hours
4.5 hours
5
Up to 2 hours
4 hours
BATTERY SERVICE LIFE
The FreeStyle Comfort batteries are designed to
last 300 charge/discharge cycles.
WARNING: DO NOT ATTEMPT TO
OPEN OR REMOVE THE PLASTIC
COVERS OF THE OXYGEN CONCEN-
TRATOR. THE UNIT SHOULD ONLY BE
OPENED BY A QUALIFIED SERVICE
TECHNICIAN.
WARNING: DO NOT OPERATE THE
OXYGEN CONCENTRATOR WITHOUT
THE AIR INTAKE FILTER IN PLACE.

20
FreeStyle Comfort
BATTERY PACK STORAGE
The oxygen concentrator battery does not need to
be fully discharged before recharging. It is
recommended to charge the oxygen concentrator
battery after each use.
Do not leave the battery in a location exposed to
excessive heat, such as in direct sunlight or a car.
Doing so could cause the battery’s performance
and life to deteriorate. It may also cause the
battery to generate heat, smoke, catch fire, or
explode. The battery pack should be stored in a
stable environment characterized by low-humidity
(less than 70% RH) and free of corrosive gasses.
To prevent rust, avoid conditions that can create
condensation such as rapid fluctuations in the
ambient temperature.
For storage of a month or more, a discharged or
partial charged state of charge between 50% and
75% (two to three LEDs) is recommended. Once
charged, remove the battery from the oxygen
concentrator.
BATTERY DISPOSAL
Your battery is rechargeable and can be recycled.
You can also contact your local city or town
offices for instructions on proper disposal of the
battery.
Cleaning
Turn OFF the unit and disconnect from AC or DC
power before any cleaning or disinfection. DO
NOT spray the outer case directly. Use a damp
(not wet) cloth or sponge. Spray the cloth or
sponge with a mild disinfectant solution to clean
the cabinet and power supplies. Proceed as
directed by the cleaner manufacturer.
WARNING: TURN OFF THE UNIT AND
DISCONNECT THE POWER CORD
FROM THE ELECTRICAL OUTLET
BEFORE YOU CLEAN THE UNIT TO
PREVENT ACCIDENTAL ELECTRICAL
SHOCK AND BURN HAZARD. ONLY
YOUR EQUIPMENT PROVIDER OR
A QUALIFIED SERVICE TECHNICIAN
SHOULD REMOVE THE COVERS OR
SERVICE THE UNIT.
WARNING: CARE SHOULD BE TAKEN TO
PREVENT THE OXYGEN CONCENTRATOR AND
THE BATTERY PACK FROM GETTING WET OR AL-
LOWING FLUIDS TO ENTER THE UNIT. THIS CAN
CAUSE A MALFUNCTION OR SHUT DOWN, AND
CAUSE AN INCREASED RISK FOR ELECTRICAL
SHOCK OR BURNS.
WARNING: DO NOT USE LIQUID DIRECTLY ON
THE UNIT. A LIST OF UNDESIRABLE CHEMICAL
AGENTS INCLUDES BUT IS NOT LIMITED TO THE
FOLLOWING: ALCOHOL AND ALCOHOL-BASED
PRODUCTS, CONCENTRATED CHLORINE-BASED
PRODUCTS (ETHYLENE CHLORIDE), AND OIL-
BASED PRODUCTS.THESE ARE NOT TO BE USED
TO CLEAN THE PLASTIC HOUSING ON THE CON-
CENTRATOR, AS THEY CAN DAMAGE THE UNIT.
WARNING: CLEAN THE CABINET, CONTROL
PANEL, AND POWER CORD ONLY WITH A MILD
HOUSEHOLD CLEANER APPLIED WITH A DAMP
(NOT WET) CLOTH OR SPONGE, AND THEN WIPE
ALL SURFACES DRY.DO NOT ALLOW ANY LIQUID
TO GET INSIDE THE CONCENTRATOR. PAY
SPECIAL ATTENTION TO THE OXYGEN OUTLET
FOR THE CANNULA CONNECTION TO MAKE
SURE IT REMAINS FREE OF DUST, WATER, AND
PARTICLES.
WARNING: USE A DAMP (NOT WET) CLOTH OR
SPONGE TO CLEAN THE BATTERY PACK. FIRST
SPRAY THE CLOTH OR SPONGE WITH A MILD
HOUSEHOLD CLEANER AND CLEAN THE BAT-
TERY PACK HOUSING.
WARNING: DO NOT DISINFECT/CLEAN WITH
AUTOMATED WASHING SYSTEM