FreeStyle® Comfort®
Portable Oxygen Concentrator with autoSAT®, UltraSense® and autoDOSETM

User Manual (English)

FreeStyle Comfort

User Controls & System Status Indicators
ISO 7000; Graphical symbols for use on
equipment—Index and synopsis
Read user’s manual before operation.
Reg. # 1641
Storage or operating temperature
range. Reg. # 0632

Storage humidity range Reg. # 2620

Council Directive 93/42/EEC; concerning
medical devices
Authorized representative in theEuropean Community
If the product unique device identifier(UDI) label has the CE#### symbolon it, the device complies with therequirements of Directive 93/42/EEC
concerning medical devices. The
CE#### symbol indicates notified
body number.
IEC 60417

Atmospheric pressure limitation. Reg.
# 2621

Class II Equipment, Double
Insulated Reg. # 5172

Name and address of manufacturer.
Reg. # 3082

Power switch. Reg. # 5009

Date of manufacturer. Reg. # 2497

ETL Certification
Safety agency for CAN/CSA C22.2
No. 601.1 M90 for medical electricalequipment

Catalog Number. Reg. # 2493
Serial Number. Reg. # 2498
This way up. Reg. # 0623

Internal Symbols
Keep away from flammable materials,
oil and grease.

Fragile, handle with care. Reg. #0621

Do not disassemble.

Keep away from rain, keep dry. Reg.
# 0626

Increase flow.

Stacking limit by number. Reg. # 2403

Decrease flow.

ISO 7010: Graphical symbols—Safety colors andsafety signs—Registered safety signs
The instruction manual must be read.
Reg. # M002
Keep away from open flame, fire,
sparks. Open ignition source andsmoking prohibited. Reg. # P003
Do not smoke near unit or while
operating unit. Reg. # P002
Type BF applied part (degree ofprotection against electric shock).
Reg. # 5333
Warning. Reg. # W001

2 - ENG PN MN232 K | User Manual

Menu button.
RTCA/DO160 Section
21
Category M
Compliant

RTCA DO160 Section 21 Category
M Compliant. FAA SFAR 106
requirement
Class II Equipment, Double Insulated
FAA Approved – POC

21 CFR 801.15: Code of Federal Regulations Title
21
Federal law restricts this device tosale by or on the order of a physician.

FreeStyle Comfort
Council Directive 2012/19/EU: waste electrical andelectronic equipment (WEEE)
WEEE

IEC 60601-1: Medical electrical equipment Part 1
General requirements for basic safety and essential performance
Drip Proof
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.: www.caireinc.com/corporate/patents/ .

What is the Oxygen Concentrator
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 molecularsieve. This material separates the oxygen fromthe nitrogen and allows only the oxygen to passthrough. The result is a flow of high-concentration
oxygen delivered to the user.

prescribed a flow or setting to address yourparticular respiratory condition.
Although oxygen is a non-addictive drug,
unauthorized oxygen therapy can be dangerous.
You must seek medical advice before you use thisoxygen concentrator. The Equipment Provider who
supplies your oxygen equipment will demonstrate
how to set the prescribed flow rate.

Operator Profile

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 beginningof 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 islightweight enough to be carried via shoulder strap.
It can be operated on AC (wall), DC (vehicle) orbattery power.

Concentrators are intended to supply supplemental
oxygen to users suffering from discomfort due toailments which effect the efficiency of one’s lungs
to transfer oxygen in the air to their bloodstream.
Portable oxygen concentrators (POCs) do not store
or contain oxygen. They do not need to be refilled,
and can recharge anywhere AC or DC power isavailable (except on an airplane). This makes theuser relatively self-sufficient in terms of in-homeuse, ambulation (both within and outside of thehome), mobility, and overall lifestyle. Oxygen
concentrator use requires a physician’s prescription
and is not intended for life support use.

Intended Use

Although oxygen therapy can be prescribed forusers of all ages, the typical oxygen therapy user
is older than 65 years of age and suffers from avariety of respiratory diseases, including Chronic
Obstructive Pulmonary Disease (COPD). Users
typically have good cognitive abilities and must
be able to communicate discomfort. If the user
is unable to communicate discomfort, or unable
to read and understand the concentrator labelingand instructions for use, then use is recommended
only under the supervision of one who can. If any
discomfort is felt while using the concentrator,
users are advised to contact their healthcare
provider. Users are also advised to have back-up
oxygen available (i.e. cylinder oxygen) in the eventof a power outage or concentrator failure. There areno other unique skills or user abilities required forconcentrator use.

The CAIRE FreeStyle Comfort Oxygen Concentrator is intended for the administration of supplemental oxygen. The device is not intended for life
support nor does it provide any patient monitoring
capabilities.

Why Your Physician
Prescribed Oxygen
Many people suffer from a variety of heart, lung,and other respiratory diseases. A significant numberof these people can benefit from supplemental
oxygen therapy at home, when traveling, or while
participating in daily activities away from home.
Oxygen is a gas that makes up 21% of the ambient
air we breathe, and our bodies depend on a steadysupply to function properly. Your physician

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FreeStyle Comfort

Unpacking Your FreeStyle Comfort
Verify that all of the components listed are included in
the package. If any items are
missing, contact your oxygen
provider immediately.

Standard Accessories• Portable Oxygen Concentrator• Carrying Bag• Shoulder Strap• 8-Cell Battery Pack
• AC Power Supply• AC Power Cord
• DC Power Supply• User Manual

Optional Accessories• Additional 8-Cell Battery Pack• 16-Cell Battery Pack
• Desktop Charger• Carry-all Accessory Bag

Getting to Know Your FreeStyle Comfort
Become familiar with the key features of the FreeStyle Comfort and its user interface.

Front View
Strap Attachment

User Interface

OxygenOutletAir Outlet

Air Intake/Filters
Air Intake/
Filters
Power Port
Receptacle
Tab
Battery Pack
Battery Pack
Release Button
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Top View
Display Screen
Increase Flow

Power Button

Menu Button

Decrease Flow

Display Screen On Battery
Flow Setting

Battery Display

autoSAT Indicator
Battery
Percentage
Remaining

Alarm Display
Bolus Delivery
Indicator

Display Screen On AC/DC Power
Flow Setting
Battery Display

Alarm Display
Space

Charge Indicator

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FreeStyle Comfort

Important!

Safety Instructions are defined as follows:
WARNING: IMPORTANT SAFETY INFORMATION FOR HAZARDS THAT MIGHT
CAUSE SERIOUS INJURY.
CAUTION: Important information for preventing damage to the FreeStyle Comfort.
Note: Information needing special attention.

Indications for Use
WARNING: IT IS VERY IMPORTANT
TO SELECT ONLY THE PRESCRIBEDLEVEL OF OXYGEN. DO NOT CHANGE
THE FLOW SELECTION UNLESS YOUHAVE BEEN DIRECTED TO DO SO BY A
LICENSED CLINICIAN.
WARNING: FEDERAL (USA) LAW RESTRICTS THIS
DEVICE TO SALE OR RENTAL BY ORDER OF APHYSICIAN OR OTHER LICENSED HEALTH CAREPROVIDER.
WARNING: THIS UNIT IS NOT TO BE USED FOR
LIFE SUPPORT. GERIATRIC, PEDIATRIC, OR
ANY OTHER USER UNABLE TO COMMUNICATEDISCOMFORT 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 MUSTBE DETERMINED FOR EACH USER INDIVIDUALLYFOR THEIR NEEDS AT REST, DURING EXERCISE,
AND WHEN TRAVELING.
WARNING: SOME RESPIRATORY EFFORTS
OF THE PATIENT MIGHT NOT TRIGGER THE
CONSERVING FUNCTION.
WARNING: THE FREESTYLE COMFORT IS NOTINTENDED FOR USE WITH A TRACHEOTOMISEDPATIENT.
WARNING: PREGNANT OR NURSINGWOMEN SHOULD NOT USE ACCESSORIESRECOMMENDED IN THIS MANUAL, THEY MAY
CONTAIN PHTHALATES.

Contraindications for Use

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WARNING: IN CERTAIN
CIRCUMSTANCES, THE USE OF
NON-PRESCRIBED OXYGEN CAN BE
HAZARDOUS. 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 ELECTRICALLYPOWERED DEVICE, THE USER MAY EXPERIENCEPERIODS OF NON-OPERATION AS A RESULT OF
ELECTRICAL POWER INTERRUPTION, OR THE
NEED TO HAVE THE OXYGEN CONCENTRATORSERVICED BY A QUALIFIED TECHNICIAN. THE
OXYGEN CONCENTRATOR IS NOT APPROPRIATEFOR ANY USER WHO WOULD EXPERIENCEADVERSE HEALTH CONSEQUENCES AS THE
RESULT OF SUCH TEMPORARY INTERRUPTION.

Safety Guidelines
WARNING: NO MODIFICATION OF THISEQUIPMENT IS PERMITTEDWARNING: THIS DEVICE SUPPLIES HIGHCONCENTRATION OXYGEN THAT PROMOTESRAPID BURNING. DO NOT ALLOW SMOKING
OR OPEN FLAMES WITHIN THE SAME ROOMOF (1) THIS DEVICE, OR (2) ANY OXYGENCARRYING ACCESSORY. FAILURE TO OBSERVETHIS WARNING CAN RESULT IN SEVERE FIRE,
PROPERTY DAMAGE, AND/OR CAUSE PHYSICALINJURY OR DEATH.
WARNING: DO NOT OPERATE UNIT IN A
RESTRICTED OR CONFINED SPACE (I.E., A SMALL
CASE OR HANDBAG) WHERE VENTILATION CAN
BE LIMITED. THIS CAN CAUSE THE OXYGENCONCENTRATOR TO OVERHEAT AND IMPAIRPERFORMANCE.
WARNING: THE CONCENTRATOR SHOULD BE
LOCATED AS TO AVOID SMOKE, POLLUTANTS ORFUMES.
WARNING: IN THE EVENT THERE IS A SERIOUS
INCIDENT OCCURRING WITH THIS DEVICE,THE USER SHOULD IMMEDIATELY REPORTTHE INCIDENT TO THE PROVIDER AND/OR
THE MANUFACTURER. A SERIOUS INCIDENT IS
DEFINED AS AN INJURY, DEATH, OR POTENTIALTO CAUSE INJURY/DEATH SHOULD THERE BE
A REOCCURRENCE OF THE INCIDENT. THE
USER CAN ALSO REPORT THE INCIDENT TO
THE COMPETENT AUTHORITY IN THE COUNTRY
WHERE THE INCIDENT OCCURRED.

FreeStyle Comfort
WARNING: THE USE OF SOME OXYGENADMINISTRATING ACCESSORIESNOT SPECIFIED FOR THIS OXYGENCONCENTRATOR MAY IMPAIR ITSPERFORMANCE. RECOMMENDED ACCESSORIES ARE REFERENCED WITHIN
THIS MANUAL.
WARNING: IF THE OXYGEN CONCENTRATOR HAS
BEEN DROPPED, DAMAGED OR EXPOSED TO
WATER, PLEASE CONTACT YOUR EQUIPMENTPROVIDER FOR INSPECTION OR POSSIBLE REPAIR OF THE DEVICE. DO NOT USE THE OXYGENCONCENTRATOR IF IT HAS A DAMAGED POWER
CORD OR PLUG.
WARNING: PROPERLY SECURE, BELT OR OTHERWISE RESTRAIN THE OXYGEN CONCENTRATOR
WHEN IN A VEHICLE DURING TRANSPORT TO
PREVENT DAMAGE OR INJURY.
WARNING: THE US DEPARTMENT OF TRANSPORTATION (DOT) AND UNITED NATIONS (UN)REGULATIONS REQUIRE THE REMOVAL OF THE
BATTERY FROM THE DEVICE FOR ALL INTERNATIONAL AIRLINE TRAVEL WHEN THE OXYGENCONCENTRATOR 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 EQUIPMENTWITHOUT FIRST READING AND UNDERSTANDING
THIS MANUAL. IF YOU ARE UNABLE TO UNDERSTAND THE WARNINGS AND INSTRUCTIONS,CONTACT YOUR EQUIPMENT PROVIDER BEFOREATTEMPTING TO USE THIS EQUIPMENT; OTHERWISE, INJURY OR DAMAGE MAY RESULT.
WARNING: IF YOU FEEL DISCOMFORT OR ARE
EXPERIENCING A MEDICAL EMERGENCY, SEEKMEDICAL ASSISTANCE IMMEDIATELY.
WARNING: OPERATING THE OXYGEN CONCENTRATOR OUTSIDE OF THE OPERATIONALTEMPERATURE SPECIFICATIONS CAN LIMIT THE
CONCENTRATOR’S ABILITY TO MEET OXYGENCONCENTRATION SPECIFICATION. REFER TO THE
SPECIFICATION SECTION OF THIS MANUAL FORTEMPERATURE LIMITS.
WARNING: USE NO OIL, GREASE, OR PETROLEUM-BASED OR OTHER FLAMMABLE PRODUCTS WITH THE OXYGEN-CARRYING ACCESSORIES OR THE OXYGEN CONCENTRATOR. ONLYWATER BASED, OXYGEN COMPATIBLE LOTIONSOR SALVES SHOULD BE USED. OXYGEN ACCELERATES THE COMBUSTION OF FLAMMABLE
SUBSTANCES.

WARNING: DO NOT ALLOW EITHER THE AIRINTAKE OR THE AIR OUTLET EXHAUST TO BECOME BLOCKED. DO NOT DROP OR INSERT ANYOBJECTS INTO ANY OPENINGS ON THE DEVICE.
THIS CAN CAUSE THE OXYGEN CONCENTRATORTO 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 CAUSEPERSONAL INJURY.
WARNING: DO NOT SHORT-CIRCUIT THE
BATTERY’S METAL CONTACTS WITH METALLICOBJECTS, 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 SUPPLYINTO A GROUND FAULT INTERRUPTED (GFI)
OUTLET ONLY.
WARNING: THE OXYGEN CONCENTRATORSHOULD NOT BE USED ADJACENT TO OR
STACKED WITH OTHER EQUIPMENT. IF ADJACENT OR STACKED USE IS UNAVOIDABLE, THE
DEVICE SHOULD BE OBSERVED TO VERIFYNORMAL OPERATION.
WARNING: USE OF CABLES AND ADAPTERS
OTHER THAN THOSE SPECIFIED, WITH THE
EXCEPTION OF CABLES AND ADAPTERS SOLDBY THE MANUFACTURER OF THE MEDICAL ELECTRICAL EQUIPMENT AS REPLACEMENT PARTS
FOR INTERNAL COMPONENTS, MAY RESULT IN
INCREASED EMISSIONS OF DECREASED IMMUNITY OF THE OXYGEN CONCENTRATOR.
WARNING: USE ONLY ELECTRICAL VOLTAGE
SPECIFIED ON THE SPECIFICATION LABELAFFIXED TO THE DEVICE.
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.

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FreeStyle Comfort
CAUTION: In the event of an alarm or you
observe the Oxygen Concentrator is notworking properly; consult the Troubleshooting section in this manual. If you
cannot resolve the problem, consult yourEquipment Provider.
CAUTION: To prevent a void warranty, follow all
manufacturers’ instructions.
WARNING: DO NOT ATTEMPT ANY
MAINTENANCE OTHER THAN THE POSSIBLE SOLUTIONS LISTED WITHIN THISMANUAL. DO NOT REMOVE COVERS,ONLY YOUR EQUIPMENT PROVIDER
OR A QUALIFIED SERVICE TECHNICIANSHOULD REMOVE THE COVERS ORSERVICE 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 SUPPLEMENTALOXYGEN IN THE EVENT OF A POWER OUTAGE,
ALARM CONDITION, OR MECHANICAL FAILURE.
CONSULT YOUR PHYSICIAN OR EQUIPMENTPROVIDER FOR THE TYPE OF RESERVE SYSTEMREQUIRED.
WARNING: DO NOT ALLOW EITHER THE AIRINTAKE OR THE AIR OUTLET VENTS TO BECOMEBLOCKED. DO NOT DROP OR INSERT ANYOBJECTS INTO ANY OPENINGS ON THE DEVICE.
THIS CAN CAUSE THE OXYGEN CONCENTRATORTO OVERHEAT AND IMPAIR PERFORMANCE.
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, CANDLES,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 STEPSMAY SAVE YOUR LIFE: TURN OFF THE OXYGENCONCENTRATOR, TAKE OFF THE CANNULA,
AND LEAVE THE ROOM WHERE THIS DEVICE IS
LOCATED.

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WARNING: “NO SMOKING – OXYGEN IN USE”
SIGNS MUST BE PROMINENTLY DISPLAYEDIN THE HOME, OR WHERE OXYGEN IS IN USE.
USERS AND THEIR CAREGIVERS MUST BE INFORMED ABOUT THE DANGERS OF SMOKING IN
THE PRESENCE OF, OR WHILE USING, MEDICALOXYGEN.
WARNING: DO NOT USE YOUR OXYGEN CONCENTRATOR IN THE PRESENCE OF FLAMMABLE
GASES. THIS CAN RESULT IN RAPID BURNINGCAUSING PROPERTY DAMAGE, BODILY INJURIESOR 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 MUSTBE OFF AND DISCONNECTED FROM EXTERNALPOWER BEFORE REMOVING THE BATTERY PACK.
WARNING: SMALL PARTS MAY PRESENTA POTENTIAL CHOKING HAZARD.
WARNING: AVOID CONTACT WITH EXHAUST AIR
VENT FOR LONGER THAN 10 SECONDS AS IT MAY
BE WARM.
WARNING: WIND OR STRONG DRAUGHTS CANADVERSELY AFFECT ACCURATE DELIVERY OF
OXYGEN THERAPY.
WARNING: THIS PRODUCT CAN EXPOSE YOU
TO CHEMICALS INCLUDING NICKEL, WHICH IS
KNOWN TO THE STATE OF CALIFORNIA TO CAUSECANCER. FOR MORE INFORMATION, GO TO WWW.
P65WARNINGS.CA.GOV.
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 sothat it is difficult to access the power cord.

FreeStyle Comfort
CAUTION: Always place oxygen supply tubing andpower cords in a manner that prevents trip hazard or
possible accidental strangulation.
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. 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 areusing 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 orcold automobile or in other similar, high- or low-temperature environments.
Note: Portable and mobile RF communications equipment can effect 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: Operating or storing the Oxygen Concentrator outside of its normal operating temperature
range and ambient pressure range (altitude) can affectperformance 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.
CAUTION: For Oxygen Concentrators equipped withbatteries: Store in a cool and dry location to help
ensure the longevity of your battery. Storing yourOxygen Concentrator for extended periods of time athigh 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 noserviceable parts inside the battery. Keep batteries
away from children.
CAUTION: ONLY USE the Manufacturer’s provided
batteries. For proper battery disposal, contact yourEquipment Provider or your local government agency
for disposal requirements.

Note: Ensure the cannula is fully inserted and secure.
This ensures that the Oxygen Concentrator canproperly detect inspiration for oxygen delivery. During
inhalation, you should hear or feel oxygen flow to theprongs of the nasal cannula.
Note: Lithium batteries may permanently lose capacity
when exposed to extremely hot temperatures with thebatteries fully charged or completely depleted. For
extended storage, it is recommended that batteries becharged 25 to 50% and remain within a temperature
range of -4°F – 68°F (-20°C – 20°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 andwater solution, then dry thoroughly prior to use.
Note: The Manufacturer does not recommend thesterilization of this equipment.
Note: There is never a danger of depleting the oxygenin a room when you use your oxygen concentrator
unit.
WARNING: THE OXYGEN CONCENTRATOR SHOULD NOT BE OPERATEDOR PLUGGED IN TO EXTERNAL (AC/DC) POWER WITHOUT A BATTERYINSTALLED. DO NOT ATTEMPT TO
POWER ON THE UNIT OR CONNECT
IT TO EXTERNAL POWER WHEN THE
BATTERY PACK IS REMOVED.
ONLY REMOVE THE BATTERY PACK WHEN THE
UNIT IS POWERED OFF AND UNPLUGGED FROM
THE POWER SUPPLY. DO NOT ATTEMPT TOREMOVE 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 thetable above, it should be allowed to return to normal
operating temperature before being powered on.

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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 (2.3 kg)

Weight (with Double Battery Pack)

6 lbs (2.7 kg)

Nominal Sound Level***

39,93 dB(A) ± 0,42 dB(A) @ 2

Flow Settings

Pulse Setting 1, 2, 3, 4, 5

O2 Output Setting (@ 20bpm)

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*
Oxygen Monitor
Maximum Outlet Pressure
Dosing Sensitivity

90% (+5.5% / -3%)
Yes
<30 PSI> -0.1 cm H2O (adjustable)

AC Power

100–240 VAC, 50-60Hz, 120W Max

DC Power

11–18 VDC (10 max amp)

Battery Type

Lithium Ion

Battery Capacity

Single cell: 6700 mAh; Double cell: 13400 mAh

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 10000 ft (3048 m)

Transportation and Storage Temp.
(Battery)-13°F to +158°F (-25°C to +70°C) up to 10000 ft (3048 m)

Operating Altitude**-1250 to 10,000 ft (-381 to 3048 m) (tested to 700 – 1060 hPa)

Operating Humidity

15 - 95% relative humidity (non-condensing)

Storage Humidity

0 - 90% 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)** The unit will function in all environments as long as the environment is with the specified temperature and humidity
ranges. Operating outside of these operational specifications can limit the concentrator’s ability to meet Oxygen Concentration specification at higher liter flow rates. Warm up screen may continue to display until the concentrator has reachedtarget concentration or up to 15 minutes. Continue to use unit during this time.
***Sound level measured per test method Nr. 14-1 10/2018 MDS-Hi.
The expected service life is a minimum of five years. The expected shelf life of the sieve beds is approximately one year
if concentrator is unused during the entire period.

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Operating Instructions

FreeStyle Comfort

1. Locate and position the FreeStyle Comfort in aproper 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.

power port receptacle on the front, bottom rightside of the unit.

2. Install a Battery Pack in the concentrator.
a. Align the battery with the bottom housingfrom the center of the FreeStyle Comfort.

4. Connect a nasal cannula to the oxygen outlet
barb. Ensure the connection is secure before
operation.
NOTE: Any cannula(s) used other than the recommended may affect performance.

b. Slide the battery inward until you hear aclick to confirm that it has locked in place.

Note: To Equipment Provider: The following oxygen
administration accessories are recommended for use
with the FreeStyle Comfort:• Nasal Cannula with 7 feet (2.1 m) of tubing (Maximum LPM: 6 LPM): CAIRE Part Number 5408-SEQ• Additional recommended accessories information isavailable online at www.caireinc.com.

3. Insert the AC or DC power supply into the

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FreeStyle Comfort
5. Turn on the FreeStyle Comfort by pressing thepower button and select your prescribed flow
setting utilizing the increase (+) or decrease (-)
flow buttons.

Breath
Rate
15
20
25
30
35
40

autoSAT Pulse Volume (mL)*Setting
1
2
3
4
5
10.5
10.5
10.5
10.5
10.5
10.5

21.0
21.0
21.0
21.0
21.0
21.0

31.5
31.5
31.5
31.5
30.0
26.3

42.0
42.0
42.0
35.0
30.0
26.3

52.5
52.5
42.0
35.0
30.0
26.3

*Tolerance is +/- 15%

A brief audible alarm will sound to indicate thedevice has powered on.
Note: When the FreeStyle Comfort is initially turnedon the default flow setting is 2. If the setting ischanged, the unit will power on to the previous flow
setting.
6. Position the nasal cannula on your face per the
manufacturer’s instructions provided with thecannula and breathe normally. You should feel apuff 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 flow settings.

Breath
Rate
15
20
25
30
35
40

non-autoSAT Pulse Volume (mL)* Setting
1
2
3
4
5
14.0
10.5
8.4
7.0
6.0
5.3

28.0
21.0
16.8
14.0
12.0
10.5

42.0
31.5
25.2
21.0
18.0
15.8

56.0
42.0
33.6
28.0
24.0
21.0

70.0
52.5
42.0
35.0
30.0
26.3

8. Turn the FreeStyle Comfort off by pressing thepower button.
Note: The display screen will enter standby mode anddim after 20 seconds. Press any button to wake thescreen out of standby mode.
9. For Advanced Features see Menu Navigation
Instructions

SPECIAL PRODUCT FEATURES
autoSAT®
CAIRE’s proprietary autoSAT feature allows the
FreeStyle Comfort to deliver a consistent volumeof oxygen (bolus) per breath, up to a maximum
breath rate. As the user’s breath rate increases
during activities like walking, the autoSAT featureadjusts the device operation to maintain a set bolus
volume.
UltraSense®
This sensitive pulse dose trigger detects thepressure change during your breath, and releases
the pulse of oxygen when you inhale.
autoDOSE™
Should a “no breath alarm” occur, this feature willpulse oxygen at 20 breaths per minute at the unit’s
current flow setting until the alarm state is resolved.
12 - ENG PN MN232 K | User ManualPower Supplies
The FreeStyle Comfort can be powered in threeways:• Rechargeable Battery Pack
• AC Power• DC Power
Information on the operation of each of these components is in the following sections.
WARNING: USE ONLY THE POWER
SUPPLIES OUTLINED IN THIS USER’SMANUAL. USE OF NON-CAIRE POWER
SUPPLIES AND BATTERY PACKS CANCAUSE DAMAGE TO THE UNIT AND
IMPROPER OPERATION.

FreeStyle Comfort
REMOVING THE BATTERY

Push the battery release button downward awayfrom the FreeStyle Comfort. While HOLDING thisbutton, slide the battery out by pulling it away fromthe concentrator.
WARNING: THE OXYGEN CONCENTRATOR MUST BE OFF AND DISCONNECTED FROM EXTERNAL POWER BEFOREREMOVING THE BATTERY PACK.

BATTERY PACKThe FreeStyle Comfort can be operated by the rechargeable battery pack which is supplied with thedevice. There are no operational limitations of theconcentrator when running from the battery pack.
All flow rates are available on battery power.

CHECKING BATTERY PACK CHARGEINSTALLING THE BATTERY

Align the battery with the bottom housing from thecenter of the FreeStyle Comfort. Push the battery
inward until you hear a click to confirm that it has
locked in place.

To check the battery charge when it is installed in
the FreeStyle Comfort, reference the battery icon
and the estimated time remaining on the display.
80–100%60–80%

40–60%

20–40%

20%

PN MN232 K | User Manual ENG - 13

FreeStyle Comfort
Note: If the battery is in the process of charging, a plug
indicator will show instead of the charge percentage
remaining.
To check the battery charge when it is not installedin the FreeStyle Comfort, lay it flat and press the
TEST button. The battery gauge indicator lights(25-100%) will illuminate to the right of the TEST
button to indicate the level of the battery packcharge.

BATTERY OPERATING DURATION

When external AC or DC power is disconnected,
the concentrator will automatically switch over tousing battery power if a charged battery is installed.
The table below shows the typical durations fora new battery pack. Battery pack durations willremain constant regardless of your breath rate.
Pulse
Setting

Single (8-cell)
Battery Duration

Double (16-cell)
Battery Duration1

up to 8 hours

up to 16 hours

2

up to 4 hours

up to 8 hours

3

up to 3 hours

up to 6 hours

4

up to 2.25 hours

up to 4.5 hours

5

up to 2 hours

up to 4 hours

TYPICAL BATTERY RECHARGE TIME

The typical time to fully recharge your battery packfrom a fully discharged battery is 3.5 hours for asingle battery, and 6.0 hours for a double battery.

INITIAL CHARGINGThe new battery supplied with your FreeStyle
Comfort is only partially charged when it is shippedfrom the factory. Before using for the first time, you
should fully charge the battery pack using either
AC or DC power.

GENERAL CHARGING INFORMATIONThe FreeStyle Comfort will recharge the battery
pack anytime it is installed in the concentrator andthe concentrator is connected to an external AC or
DC power source (except on an airplane).
Battery is fully charged when it displays 100%.
Alternately, the battery pack may be charged using
the optional desktop charger.

14 - ENG PN MN232 K | User Manual

Note: The battery may not initially start charging if thebattery pack has been fully depleted.

BATTERY SERVICE LIFE

The FreeStyle Comfort batteries are designed tolast 300 charge/discharge cycles.

AC & DC Power Supply

FreeStyle Comfort

The FreeStyle Comfort comes standard with AC
and DC power supplies.
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.

AC POWER

2. Connect the AC power cord to the AC power
brick.

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 any
time AC power is available (except on an airplane).
The battery pack will recharge whether the FreeStyle Comfort is powered on or off.
WARNING: DO NOT CONNECT EXTERNAL POWER WITHOUT A BATTERYPACK INSTALLED IN THE OXYGENCONCENTRATOR.
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 sothat the connection is secure.

3. Connect the opposite end of the AC power cord
to the wall or other appropriate electrical outlet.

PN MN232 K | User Manual ENG - 15

FreeStyle Comfort
4. Turn on the FreeStyle Comfort by pressing thepower button and select your prescribed flow
setting utilizing the increase (+) or decrease (-)
flow buttons.

Note: If the battery pack needs to be recharged, thebattery icon on the display will have a single orangebar.

DC POWER

DC power is for use in the accessory outlets ofautomobiles, 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 isavailable. The battery pack will recharge both if theunit is off, or on and in use.
WARNING: DO NOT CONNECT EXTERNAL POWER WITHOUT A BATTERYPACK INSTALLED IN THE OXYGENCONCENTRATOR.
WARNING: DO NOT OPERATE THE DEVICE ON
12 VDC CAR OUTLETS WHILE THE VEHICLE IS
TURNED OFF.
1. Turn on your motor vehicle.
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 theconnection is secure.

16 - ENG PN MN232 K | User Manual

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 pressing thepower button and select your prescribed flow
setting utilizing the increase (+) or decrease (-)
flow buttons.
Note: If the battery pack needs to be recharged, thebattery icon on the display will have a single orangebar.

FreeStyle Comfort
Cleaning, Care & Routine Maintenance
ROUTINE MAINTENANCE

Preventative MaintenanceThe device is maintenance free. Filters inside thedevice are intended to last the lifetime of the device. If the device is not working properly, the unit
should be returned to provider for repair. Servicing
of internal components inside of the cabinet of
the FreeStyle Comfort must be performed by theoxygen provider.
The operator of the unit is responsible for thefollowing maintenance procedure.
• Weekly – Clean the Air Intake Filters
WARNING: DO NOT ATTEMPT TO OPEN
OR REMOVE THE PLASTIC COVERS OF
THE OXYGEN CONCENTRATOR. THE
UNIT SHOULD ONLY BE OPENED BY AQUALIFIED SERVICE TECHNICIAN.

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 otherlarge 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 theoperating conditions. Follow these steps to properly
clean the air intake filters.
1. Remove the two filters from the front of the
FreeStyle Comfort by pushing up on the corresponding tab and pulling outward.

WARNING: DO NOT OPERATE THE
OXYGEN CONCENTRATOR WITHOUTTHE AIR INTAKE FILTER IN PLACE.

BATTERY PACK CARE

Do not allow the battery pack to be exposed toliquids.
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 youroxygen provide before use.
Do not place the battery in or near a microwave orother cooking appliances.

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 toexcessive heat, such as in direct sunlight or in a car.
Doing so could cause the battery’s performance andlife 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 suchas 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.

2. Wash both filters in a warm solution of soap andwater.
3. Rinse the filters thoroughly and remove excesswater with a soft, lint-free cloth. Ensure the filters
are completely dry before replacing it.
4. Re-install the clean, dry filters.
PN MN232 K | User Manual ENG - 17

FreeStyle Comfort
CLEANING

Turn OFF the unit and disconnect from AC or DC
power before any cleaning. DO NOT spray theouter case directly. Use a damp (not wet) clothor sponge. Spray the cloth or sponge with a mildhousehold cleaner solution to clean the cabinet andpower supplies. Proceed as directed by the cleaner
manufacturer.
WARNING: TURN OFF THE UNIT AND
DISCONNECT THE POWER CORD FROMTHE ELECTRICAL OUTLET BEFOREYOU CLEAN THE UNIT TO PREVENT
ACCIDENTAL ELECTRICAL SHOCK AND
BURN HAZARD. ONLY YOUR EQUIPMENT PROVIDER OR A QUALIFIED SERVICE TECHNICIAN SHOULD REMOVETHE COVERS OR SERVICE THE UNIT.
WARNING: CARE SHOULD BE TAKEN TO PREVENTTHE OXYGEN CONCENTRATOR AND THE BATTERY PACK FROM GETTING WET OR ALLOWINGFLUIDS TO ENTER THE UNIT. THIS CAN CAUSE A
MALFUNCTION OR SHUT DOWN, AND CAUSE AN
INCREASED RISK FOR ELECTRICAL SHOCK ORBURNS.
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 CONCENTRATOR,
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 TOGET 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.

18 - ENG PN MN232 K | User Manual

WARNING: USE A DAMP (NOT WET) CLOTH ORSPONGE TO CLEAN THE BATTERY PACK. FIRSTSPRAY THE CLOTH OR SPONGE WITH A MILD
HOUSEHOLD CLEANER AND CLEAN THE BATTERYPACK HOUSING.
WARNING: DO NOT CLEAN WITH AUTOMATED
WASHING SYSTEM.

CANNULA REPLACEMENT

Always follow the cannula manufacturer’s instructions for proper use. Replace the nasal cannula or
oxygen tubing every 3 to 6 months (if daily use, 3months) as per manufacturer’s recommendation
as recommended by the cannula manufacturer oryour oxygen provider. Your physician or oxygen provider will provide you with cleaning andreplacement instructions.
Additional supplies for replacement are available
through your oxygen provider.

FreeStyle Comfort

Alarm Conditions
Priority #Alarm
Description

1

System
Malfunction
Battery High
Temperature

Display

AudibleSignalMore Details / Suggested Action

1 beepevery 20
sec

Unit will alarm when battery temperature isapproaching safety shutdown threshold.
If shutdown threshold is reached, unit will
shut down. If external power is connected,
alarm screen will display and audible alarm
will continue for 2 min.
Test with battery at room temperature. If
problem persists, contact provider.

2

System
MalfunctionHigh
Temperature

1 beepevery 20
sec

Unit will alarm when internal temperature isapproaching shutdown threshold.
If shutdown threshold is reached, unit will
shut down and alarm screen will display
and audible alarm will continue for 2 min.
Ensure there are no blockages on any
vents of the unit. If problem persists,
contact provider.

3

4

System
Malfunction
High
Pressure

1 beepevery 20
sec

No Breath
Detected

1 beepevery 30sec

If shutdown threshold is reached, unit will
shut down and alarm screen will display
and audible alarm will continue for 2 min.
If problem persists, contact provider.
No breath detected for 15 seconds.
Activated after first breath or warm up
screen is off, whichever comes sooner.
Check cannula for kinks or leaks. Increase
the sensitivity setting. If problem persists,
contact provider.

5

Low Battery
Shut Down

6

Warm Up

Priority #Alarm
Description

Display

1 beepevery 30
sec

Alarms until battery runs out of power andunit shuts down.

none

Unit will start by auto-dosing until a breathis detected or Warm up ends, whicheveris sooner.

AudibleSignalMore Details

Charge battery.

PN MN232 K | User Manual ENG - 19

FreeStyle Comfort
7

Low
Concentration

1 beepevery 30
sec, forup to 5min

If problem persists, contact provider.

8

System
Malfunction
Flow Rate(OCD Valve
Failure,Obstructionof GasPathway)

1 beepevery 30
sec

If problem persists, contact provider.

9

Low Battery
Warning

1 beep,no repeat

Charge battery.

10

Breathing
Rate
Exceeded

1 beepevery 60
sec

Breathing Rate exceeds 40 bpm.

11

System
Malfunction
Fan Failurenone

If problem persists, contact provider.

12

System
Malfunction
Low Pressurenone

If problem persists, contact provider.

13

System
Malfunction
Low Temp

none

Allow unit to warm up to room temperature.
If problem persists, contact provider.

Info

Start up

1 infobeep

Screen displays at power-on and you
should hear one beep to confirm buzzer isfunctioning

If dose is being falsely triggered, decrease
the sensitivity setting. If problem persists,
contact provider.

Start up screen display current firmware
revision in bottom right corner.
Priority #Alarm
Description

20 - ENG PN MN232 K | User Manual

Display

AudibleSignalMore Details

FreeStyle Comfort
Info

Normal Run
Screen in
autoSAT
Mode (noDC Powerconnected)

none

Info

Normal Run
Screen with
autoSATdisabled (NoDC Powerconnected)

None

Info

SettingChanged

1 infobeep

InfoPlug inexternal
Power in theoff condition

none

Info

Plug inexternal
power in the
run condition

none

Info

Unplugexternal
power in theoff Condition

1 infobeep

InfoUnplugexternal
power in the
run Condition(with battery
present)

1 infobeep

Priority #Alarm
Description

Display

AudibleSignalDisplay CAIRE screen for 2 seconds,
followed by Battery & Plug status for 5 sec
before screen turns off

Display CAIRE screen for 2 seconds andthen turn display off.

More Details

PN MN232 K | User Manual ENG - 21

FreeStyle Comfort
Info

In Standby
Mode - whenup or down
button ispresseddisplay showsbattery andcharging
state

none

Info

Airplane
Mode on battery power

1 longbeep

Info

Airplane
Mode while
plugged in

1 longbeep

22 - ENG PN MN232 K | User Manual

Screen will display for 5 sec then turn off

Menu Navigation Instructions

FreeStyle Comfort

You can enter the Menu in Standby or Run mode.
In Run Mode, if an alarm condition occurs themenu will automatically be exited. If no buttons arepressed for 20 seconds, the Menu will automatically be exited. In Standby, you may need to press
the Menu button twice to wake unit, then enter the
Menu.
There are four Menu screens:
1. Status screen: Displays Firmware rev number,run time, battery discharge cycles

Airplane Mode

2. Airplane mode (ON/OFF)
3. Sensitivity: adjustable (1-5)
4. autoSAT (ON/OFF)

Sensitivty

Example Status Screen

SETTINGS MENU OPERATION
Settings menu is entered by pressing Menu/SelectbuttonautoSATin Run or Standby modes.

To scroll through the menus, push the.

Status Page

PN MN232 K | User Manual ENG - 23

FreeStyle Comfort
STATUS PAGE
The Status Page of the Freestyle Comfort shows
Firmware Revision, Run Hours, and number ofbattery cycles on the attached battery.

To cancel Airplane Mode on, press
CANCEL icon is visible.

while theAirplane Mode On Confirmed

Status Page

Run hours are shown in whole hours.
Battery Discharges is the number of cycles theattached battery has been drained and recharged.

AIRPLANE MODE
The FreeStyle Comfort ships with Airplane Modeturned off.

To turn Airplane Mode off, repeat above while
toggling to OFF.
Pressing
when the screen show the “Next”
symbol will move the menu page to the next screen
option.
Airplane Mode is intended for use in Run Mode.
Airplane Mode will be automatically disabled if theunit is left in Standby on battery power.
Note: See section Activate Airplane Mode for more
information about Airplane Mode.

SENSITIVITY MODE

Airplane Mode Main Screen

To turn the mode on, press
while the CHANGE
icon is visible. The value will toggle to the blue
word “ON”.

The FreeStyle Comfort ships with a default Sensitivity Mode setting of 2 from the factory and should
not require adjustment under normal conditions.
Sensitivity Setting can be adjusted between values
1-5, where 1 is the least sensitive, 5 is the mostsensitive.

Sensitivity Mode Screen at Setting 2
Airplane Mode On Selected

To confirm Airplane Mode on, press
while theSAVE icon is visible. The value will toggle to theblack word “ON”.

24 - ENG PN MN232 K | User Manual

To adjust the Sensitivity Mode, press
while theCHANGE icon is visible. The value will toggle tothe next blue number.

FreeStyle Comfort
AUTOSAT MODE
The FreeStyle Comfort ships with autoSAT Modeturned on.

Sensitivity Mode Setting 3 Selected

To confirm Setting 3 in Sensitivity Mode, press
while the SAVE icon is visible. The value will
toggle to the black “3”.
To cancel the Sensitivity Mode change, press
while the CANCEL icon is visible.

autoSAT Mode Main Screen

To turn the mode off, press
while theCHANGE icon is visible. The value will toggle tothe blue word “OFF”.

Sensitivity Mode Setting 3 Confirmed
autoSAT Mode On Selected

To confirm autoSAT Mode off, press
while theSAVE icon is visible. The value will toggle to theblack word “OFF”.
To cancel autoSAT Mode on, press
CANCEL icon is visible.

while theSensitivity Mode Setting 5 (Max) Confirmed

Pressing
when the screen show the “Next”
symbol will move the menu page to the next screen
option.

autoSAT Mode Off Confirmed

To turn autoSAT Mode on, repeat above while
toggling to ON.
Pressing
when the screen show the “Next”
symbol will move the menu page to the next screen
option.

PN MN232 K | User Manual ENG - 25

FreeStyle Comfort

Troubleshooting
Problem

Probable Cause

Solution

FreeStyle Comfort displays
alarm and produces
intermittent beep.

Refer to Alarm Conditions
table.

Refer to Alarm Conditions table.

Oxygen concentrator does
not turn on.

Battery is discharged.

Power the unit through the AC or DC outlet.

Not connected to external
power.

Ensure that external connects are secure.

General malfunction.

Perform a Full Power Cycle by removing thebattery and disconnecting any AC or DC external
power source. Then reinstall battery, and thepower cycle is complete. Reconnect external
power source if desired.
Contact your Equipment Provider, and change toanother source of oxygen as necessary.

All other problems.

Perform a Full Power Cycle by removing thebattery and disconnecting any AC or DC external
power source. Then reinstall battery, and thepower cycle is complete. Reconnect external
power source if desired.
Change to another source of oxygen as
available, and contact your Equipment Provider.

Note: Some alarms will cause the unit to shut down.
Note: During a total power loss, the alarm system resets (clears any previous alarms) and will only display an
alarm if the condition still exists once power is restored.

26 - ENG PN MN232 K | User ManualTravel Information

FreeStyle Comfort
1. Turn POC On using Battery Power ONLY, whenno external power source is connected.

The FreeStyle Comfort meets FAA guidelines foruse on-board commercial aircraft. Prior to any
travel (airline, train, cruise, etc.) you should:• Ensure the concentrator is in good operation
condition.
• Contact your carrier at least 48 hours prior to
departure to inform them you will be travelingwith a FreeStyle Comfort.
It is suggested to always carry extra batteries withyou on trips. For airline travel, please allow enoughbattery life to account for ground time (preflightcheck in, security, etc.) and layovers. Most airlines
require that you have an adequate number of fully
charged battery packs to power the device for atleast 150% of the expected maximum trip duration(flight times, ground time before and after theflight, connections, and unexpected delays).

2. Enable Airplane Mode using one of the following methods:
a. Follow directions to enable Airplane Mode in
Menu Navigation Instructions section.

Note: If flying, it is recommended that extra batteries
are carried on in a secure carrying bag.

FAA REGULATION

Spare batteries must be individually protected toprevent short circuits by placement in the originalretail packaging or by otherwise insulating theterminals, e.g. by taping over exposed terminals
or placing each battery in a separate plastic bag orprotective pouch, and carried in carry-on baggage
only.

b. Press and hold both Up and Down buttons for
5 seconds until you hear a long beep and see theAirplane symbol appear.

ACTIVATE AIRPLANE MODE
Battery Power
POC can be used on an aircraft per normal operating procedures using Battery Power ONLY, whenno external power source is connected
External PowerOn an airplane, if an electrical outlet is available,
operable, and its location is appropriate for use
as a POC power source, it may serve as a backup to POC batteries. In this case, the following
recommended procedure regarding the transition
from battery to aircraft electrical power must be
followed:

3. When the airplane symbol is displayed, plug in
the POC.

Note: Due to aircraft limitations, the batteries do not
charge in Airplane Mode.

PN MN232 K | User Manual ENG - 27

FreeStyle Comfort

Accessories

INSERTING UNIT INTO CARRYING BAG

For proper performance and safety, use only theselisted accessories supplied by CAIRE throughyour oxygen provider. Use of accessories not listed
below could adversely affect the performance and/or safety of the concentrator.

1. Insert unit into bottom of bag, properly aligningfilters and battery openings.

FreeStyle Comfort Standard Accessories
Carrying Bag

MI396-1

Backpack

MI459-1

Shoulder Strap

MI397-1

AC Power Supply (All Cords
Included)

PW036-1SDC Power Cord

CD041-1

External Gross Particle Filter (Right)

FI226-1

External Gross Particle Filter (Left)

FI227-1

2. Secure zipper around bottom of pouch.

Optional Accessories Available
Additional 8-Cell Battery Pack

BT034-1S

16-Cell Battery Pack

BT035-1SDesktop Battery Pack Charger

BT036-1

Carry-all Accessory Bag

MI372-2

Note: Additional options may be available for country-specific power cords where noted above. Contact
CAIRE or your oxygen provider if alternate options areneeded for order.

SHOULDER STRAP INSTALLATION
1. Shoulder strap can be attached to either the unit
directly or the carrying bag.
2. Clip strap onto the ring on the unit or bag.

Carrying Bag Instructions
To insert and secure your FreeStyle Comfort in the
carrying bag, utilize the following instructions.

28 - ENG PN MN232 K | User ManualFreeStyle Comfort
Disposal and Reuse
Always return FreeStyle Comfort, including allcomponents, to your equipment provider for proper
disposal. You can also contact your local city or
town offices for instructions on proper disposal of
the battery. The unit can be reused between people
but must be returned to equipment provider for
reprocessing.

end of its life, per Waste Electrical and Electronic
Equipment (WEEE) Directive.
Our products will comply with the restriction ofHazardous Substances (RoHS) directive. They will
not contain more than trace amounts of lead orother hazardous material content.

WEEE and RoHS

CAUTION: For proper disposal, contact
your equipment provider or local government agency for disposal instructions

This symbol is to remind the equipment
owners to return it to a recycling facility at theMaterials in Direct Contact with the Operator
Concentrator Casing..........................................................................................................................PC/ABS
Concentrator Control Panel.............................................................................Polyester EBG7 or equivalent
Concentrator Handle................................................................................................................Polycarbonate
Oxygen Outlet, Nozzle.............................................................................................................Polycarbonate
Unit Label..............................................................................................................................................Lexan
Cord Connectors...............................................................................................Polycarbonate/Vinyl chloride
Power Cord.................................................................................................................................. PVC, Metal
Power Supply...................................................................................................... .Lexan 940(Polycarbonate)
Battery Pack......................................................................................................................................PC/ABS
Battery Pack, Power Supply Labels......................................................................................... Polyester film
Concentrator Carrying Case..................................................................... Cordura, Neoprene, Nylon Lining
Strap................................................................................ Polypropylene, Acetyl, Vinyl, Cordura, Neoprene

EMC Testing
Guidance and Manufacturer’s Declaration­—Electromagnetic Emissions
The FreeStyle Comfort is intended for use in the electromagnetic environment specified below. The customer or theuser of the FreeStyle Comfort should assure that it is used in such an environment.
Emissions Test
RF emissions
CISPR 11
RF emissions
CISPR 11
Harmonic emissions
IEC 61000-3-2
Voltage fluctuations/
flicker emissions
IEC 61000-3-3ComplianceElectromagnetic Environment - GuidanceGroup 1The FreeStyle Comfort uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely tocause any interference in nearby electronic equipment.

Class BClass A
Complies

The FreeStyle Comfort is suitable for use in all establishments,
including domestic establishments and those directly connected tothe public low-voltage power supply network that supplies buildings used for domestic purposes.

PN MN232 K | User Manual ENG - 29

FreeStyle Comfort
Guidance and Manufacturer’s Declaration—Electromagnetic Immunity

The FreeStyle Comfort is intended for use in the electromagnetic environment specified below. The customer or theuser of the FreeStyle Comfort should assure that it is used in such an environment.
Immunity test
IEC 60601 test level
Compliance level
Electromagnetic environment – guidanceElectromagnetic
Floors should be wood, concrete orenvironment – guid- ±8 kV contact±8 kV contact
ceramic tile. If floors are covered withance
synthetic material, the relative±15 kV air discharge±15 kV air discharge
humidity should be at least 30 %.
IEC 61000-4-2
Electrical fasttransient/burst
IEC 61000-4-4

Surge
IEC 61000-4-5±2 kV for power supplylines±1 kV for input/output
lines±1 kV line(s) to line(s)±2 kV for power supply
lines
N/A

±2kV common mode on ±1 kV line(s) to line(s)AC lines±1kV differential on
AC lines

Mains power quality should be that of atypical professional healthcare
facility and home healthcare
environments.

Mains power quality should be that of atypical professional healthcare
facility and home healthcare
environments.

±2kV common mode on
outdoor I/O lines
0% UT for 0.5 cycle (0°, 0% UT for 0.5 cycle (0°,45°, 90°, 135°, 180°,
45°, 90°, 135°, 180°,
Mains power quality should be that of
225°, 270°, 315°)
225°, 270°, 315°)
a typical professional healthcare facility
Voltage dips, shortand home healthcare environments. If
00interruptions and
0% UT for 1 cycle (0 )0% UT for 1 cycle (0 ) the user of the FreeStyle Comfort revoltage variations
quires continued operation during poweron power supply
mains interruptions, it is recommended
70%
U
70%
U
(30%
dip
in
U
)
(30%
dip
in
U
)
input lines IEC
T
T
T
T
that the FreeStyle
0
0
for
25/30
cycles
(0
)
for
25/30
cycles(0)
61000-4-11
Comfort is powered from anuninterruptible power supply or a battery.
0% UT for 250/300
0% UT for 250/300
00cycles (0 )cycles (0 )Power frequency magnetic fields should
Power frequency
be at levels characteristic of a typical(50/60 Hz) magnetic 3 A / m
3A/mlocation in a professional healthcare
field IEC 61000-4-8
facility and home healthcare environments.
NOTE UT is the A.C. mains voltage prior to application of the test level.
NOTE In some cases, the Freestyle Comfort may reset after a significant Electrostatic Discharge, and may requirea Full Power Cycle to resume normal operation. See Troubleshooting section for more details.

30 - ENG PN MN232 K | User ManualFreeStyle Comfort
Guidance and Manufacturer’s Declaration–Electromagnetic Immunity

The FreeStyle Comfort is intended for use in the electromagnetic environment specified below. The customer or theuser of the FreeStyle Comfort should assure that it is used in such an environment.
Immunity test
IEC 60601 test level
Compliance level
Electromagnetic environment – guidance
10 Vrms
Portable and mobile RF communications
10 Vrms
Conducted RF
equipment should be used no closer
150 kHz to 80 MHz
IEC 61000-4-6
to any part of the FreeStyle Comfort,
including cables, than the recommended
separation distance calculated from theequation applicable to the frequency of
10 V/m
10 V/mRadiated RF
the transmitter.
80 MHz to 2700 MHz
IEC 61000-4-3
Recommended separation distanced  1.2 P
d  1.2 P = 80 MHz to 800 MHz
d  1.2 P = 800 MHz to 2700 MHz
where P is the maximum output power
rating of the transmitter in watts (W)according to the transmitter manufacturer
and d is the recommended separation
distance in meters (m).
Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey,a should be less thanthe compliance level in each frequency
range. b
Interference may occur in the vicinityof 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 andreflection from structures, objects and people.
aField strengths from fixed 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 withaccuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey
should be considered. If the measured field strength in the location in which the FreeStyle Comfort is used exceeds
the applicable RF compliance level above, the FreeStyle Comfort should be observed to verify normal operation. If
abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the
FreeStyle Comfort.
bOver the frequency range 150 kHz to 80 MHz, field strengths should be less than 10 V/m.

PN MN232 K | User Manual ENG - 31

FreeStyle Comfort
Recommended separation distances between portable and mobile RFcommunications equipment and the FreeStyle Comfort

The FreeStyle Comfort is intended for use in an electromagnetic environment in which radiated RF disturbances
are controlled. The customer or the user of the FreeStyle Comfort can help prevent electromagnetic interference by
maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) andthe FreeStyle Comfort as recommended below, according to the maximum output power of the communications
equipment.
Rated maximum
Separation distance according to frequency of transmitter
output power ofmtransmitter
150 kHz to 80 MHz
80 MHz to 800 MHz
800 MHz to 2,5 GHzd  1.2 P
d  1.2 P
d  1.2 P
W
0,01
0.12
0.12
0.23
0,1
0.38
0.38
0.73
1
1.2
1.2
2.3
10
3.8
3.8
7.3
100
12
12
23
For transmitters rated at a maximum output power not listed above, the recommended separation distance d inmeters (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 andreflection from structures, objects and people.

Classification

Type of protection against electric shock:Class II
Protection from electric shock is			achieved by double insulation.
Degree of protection against electric shock:Type BF Equipment providing a particular		 degree of protection against electric
		 shock regarding		 1) allowable leakage current;		 2) reliability of protective earth connection
		 (if present).
		 Not intended for direct cardiac application.
Independent testing for Medical Electrical Equipment Standard:
Tested to be in compliance with
• IEC 60601-1 edition 3.1: Medical Electricalequipment - Part 1 General Requirements forsafety.
• CAN/CSA C22.2 No. 60601-1-8 edition
2.1, Medical Electrical Equipment – Part 1:
General Requirements for Safety
Protection against potential electromagnetic orother interference between the equipment and otherdevices.
• Tested to be in compliance with EN 60601-1-2/IEC 60601-1-2: 4th Edition.
32 - ENG PN MN232 K | User Manual• Tested to be in compliance with RTCA/DO160
Section 21 Category M.
• CISPR 11 / EN 55011 Class B Group 1,“Industrial, Scientific, and Medical (ISM)
Equipment”• FCC Part 15, Subpart B – Class B
Unintentional Radiators
IP22 - Protection against ingress of fingers orsimilar objects greater than 12.5 mm diameter.
Vertically dripping water shall have no harmful
effect when the enclosure is tilted at an angle of
15° from its normal position.
Method of cleaning and infection control allowed:
Please refer to “Cleaning, Care, and Proper
Maintenance” section of this FreeStyle User
Manual.
Degree of safety of application in the presence offlammable anesthetic gases:
Equipment not suited for such application.
Mode of operation: Continuous duty.

NotesFreeStyle Comfort

PN MN232 K | User Manual ENG - 33

FreeStyle Comfort

Notes

34 - ENG PN MN232 K | User ManualNotesFreeStyle Comfort

PN MN232 K | User Manual ENG - 35

www.c air e inc. com

CAIRE Inc.
2200 Airport Industrial Dr., Ste. 500
Ball Ground, GA 30107 U.S.A.
Medical Product Service GmbH
Borngasse 20
35619 Braunfels, Germany
Tel: +49 (0) 6442-962073
E-mail: info@mps-gmbh.eu
CAIRE and CAIRE Inc. are registered trademarks of CAIRE Inc. Please visit
our website below for a full listing of trademarks. Trademarks: www.caireinc.
com/corporate/trademarks/.
© Copyright 2021 CAIRE Inc. All Rights Reserved. CAIRE Inc. reserves
the right to discontinue its products, or change the prices, materials,
equipment, quality, descriptions, specifications and/or processes to its
products at any time without prior notice and with no further obligation orconsequence. All rights not expressly stated herein are reserved by us, asapplicable.

|MN232-K0~
4 Nov 2021

PN MN232 K