FreeStyle® Comfort®
Portable Oxygen Concentrator with UltraSense® and autoDOSE®

User Manual (English)

FreeStyle Comfort

User Controls & System Status Indicators
ISO 7000
Operator’s manual; operating instructions. Reg. # 1641
The country and date of manufacture.
The “CC” identifies the two-lettercountry code of the country of manufacture. The date of manufacture is in
YYYY-MM-DD format. Reg. # 6049

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

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

Do not smoke near unit or while
operating unit. Reg. # P002

Stacking limit by number, where “n”
indicates the maximum number ofunits allowed. Reg. # 2403

Warning. Reg. # W001
IEC 60417
Type BF applied part (degree ofprotection against electric shock).
Reg. # 5333

Catalog Number. Reg. # 2493
Serial Number. Reg. # 2498
Storage or operating temperature
range. Reg. # 0632
Storage humidity range. Reg. # 2620
Atmospheric pressure limitation. Reg.
# 2621Name and address of manufacture.
Reg. # 3082

Class II Equipment, Double InsulatedReg. # 5172
EU Regulation 2017/745
Authorized representative in theEuropean Community
If the product unique device identifier(UDI) label has the CE#### symbolon it, the device complies with therequirements of concerning medical
devices. The CE#### symbol indicates notified body number.
Additional Symbols

This way up. Reg. # 0623

Keep away from flammable materials,
oil and grease.

Fragile, handle with care. Reg. # 0621

Do not disassemble.

Contains hazardous substances. Reg.
# 3723

Increase flow.
Decrease flow.

Importer. Reg. # 3725

Power switch. Reg. # 5009

O2 Outlet
RTCA/DO160 Section
21
Category M
Compliant

2 - ENG PN MN250 J | User Manual

The manufacturer of this POC hasdetermined this device conforms to
all applicable FAA acceptance criteria
and use on board aircraft.
The manufacturer of this POC hasdetermined this device conforms to
all applicable FAA acceptancecriteria and use on board aircraft.

FreeStyle Comfort
Recycle Symbol
Authorized representative in Switzerland (ADD)
If the device bears the UKCA markas shown with UKCA#### indicating
the notified body number, this device
complies with UKCA regulations.
21 CFR 801.15
Federal law restricts this device tosale by or on the order of a physician.
ETL Certification
Certified for both the U.S. and Canadian markets, to the applicable U.S.
and Canadian standards
Contains FCC ID: WAP2001
FCC NoticeThis device may contain CYBLE-022001-00,
including the antenna 2450AT18B100 fromJohnson Technology, complies with par 15 of the
FCC rules. The device meets the requirements
for modular transmitter approved as detailedin FCC public notice DA00-1407. Transmitter
operation is subject to the following two
conditions (1) The device may not cause harmfulinterference, and (2) This device must accept
any interference received, including interference
that may cause undesired operation. The productmay be covered by one or more patents, US andinternational. Please visit our website below
for the listing of applicable patents. Pat: www.
caireinc.com/corporate/patents
Graphical Symbols for Use on Equipment
IEC 60417
Direct Current Reg. # 5031

Council Directive 2012/19/EU
WEEE
This symbol is to remind the equipment owners to return it to a recycling
facility at the end of its life, per Waste
Electrical and Electronic Equipment(WEEE) Directive.
Our products will comply with therestriction of Hazardous Substances(RoHS) directive. They will not contain more than trace amounts of leador other hazardous material content.
IEC 60601-1-8
Low Priority Technical Alarm
ISO 15223-1
Medical Device. Reg. # 5.7.7
Unique device identifier # 5.7.10
A S/NZS 4417.1, AS/NZS 4417.2
ACMA Regulatory ComplianceMark– indicates compliance with
ACMA regulations (ADD)
Wireless Technology
Connection types

SSP, iAP2, GATT

Frequency

2402 to 2480 MHz

Max RF power output+4 dBmOperating range

10m (Class 2)

It is recommended that the machine is at a minimum
distance of 0.43” (1.1 cm) from the body during
operation. Not applicable to masks, air tubing, oraccessories.

Alternating Current Reg. # 5032
IEC 60601-1
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FreeStyle Comfort

What is the Oxygen
Concentrator

The air we breathe contains approximately 21%
oxygen, 78% nitrogen, and 1% other gases. In the
FreeStyle® Comfort®, room air is drawn into themachine 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.
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 is lightweight
enough to be carried via shoulder strap. It can be
operated on AC (wall), DC (vehicle) or battery
power.

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

4 - ENG PN MN250 J | User Manual

Operator Profile
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.

Guidelines for Oxygen Therapy
Users: Considerations andRecommendations
The typical oxygen therapy user is older than 65
years of age and suffers from a variety 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 theconcentrator labeling and instructions for use, thenuse is recommended only under the supervision of
one who can. If any discomfort is felt while using
the concentrator, users are advised to contact theirhealthcare provider. Users are also advised to haveback-up oxygen available (i.e. cylinder oxygen) in
the event of a power outage or concentrator failure.
There are no other unique skills or user abilities
required for concentrator use.

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

FreeStyle Comfort
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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FreeStyle Comfort
Top View

Display Screen

Increase Flow

Power Button

Decrease Flow

Display Screen On Battery
Battery Display

Flow Setting

Battery
Percentage
Remaining

Alarm Display
Space
Bolus Delivery
Indicator

Display Screen On AC/DC Power
Flow Setting
Battery Display

Alarm Display
Space

6 - ENG PN MN250 J | User Manual

Charge IndicatorImportant!

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

Indications for Use
Intended 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.
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 DEVICE HAS NOT BEEN TESTEDOR APPROVED FOR USE WITH PEDIATRICPATIENTS.
WARNING: THIS UNIT IS NOT TO BE USED FOR
LIFE SUPPORT. ADDITIONAL MONITORING MAY
BE REQUIRED FOR ANY USER WHO IS UNABLE
TO COMMUNICATE DISCOMFORT WHILE USING
THIS DEVICE. USERS WITH HEARING AND/OR
SIGHT IMPAIRMENT(S) MAY NEED ASSISTANCE
WITH MONITORING ALARMS.

FreeStyle Comfort
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: THIS DEVICE IS INTENDED FOR USE IN
THE HOME HEALTHCARE AND SIMILAR OUTPATIENT ENVIRONMENTS.
WARNING: THIS DEVICE IS INTENDED TO BE
USED BY THE PATIENT RECEIVING OXYGENTHERAPY.
WARNING: PREGNANT OR NURSING WOMENSHOULD NOT USE ACCESSORIES RECOMMENDED IN THIS MANUAL, THEY MAY CONTAINPHTHALATES.

Contraindications for Use
WARNING: IN CERTAIN CIRCUMSTANCES, THE USE OF NON-PRESCRIBEDOXYGEN 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: THIS DEVICE IS NOT INTENDED FOR
USE IN OR NEAR MAGNETIC RESONANCE ENVIRONMENTS, SUCH AS MRI MACHINES.
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 APPROPRIATE FOR ANY USER WHO WOULD EXPERIENCEADVERSE HEALTH CONSEQUENCES AS THE
RESULT OF SUCH TEMPORARY INTERRUPTION.

WARNING: PULSE DOSE MODE SETTINGS MUSTBE DETERMINED FOR EACH USER INDIVIDUALLYFOR THEIR NEEDS AT REST, DURING EXERCISE,
AND WHEN TRAVELING.

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FreeStyle Comfort

Safety Guidelines

WARNING: NO MODIFICATION OF THISEQUIPMENT IS PERMITTEDWARNING: THIS DEVICE SUPPLIES HIGH-CONCENTRATION 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 ACCESSORY. FAILURE TO OBSERVE THIS WARNING CANRESULT IN SEVERE FIRE, PROPERTY DAMAGE,
AND/OR CAUSE PHYSICAL INJURY OR DEATH.
WARNING: THIS DEVICE IS NOT APPROVED FOR
USE IN ALL ENVIRONMENTS. EXPOSURE TO
CERTAIN ELECTROMAGNETIC SOURCES MAY
RESULT IN INTERFERENCE OR UNINTENDED
DEVICE PERFORMANCE. IN THE EVENT OF
INTERFERENCE THE DEVICE SHOULD BE SHUT
DOWN IMMEDIATELY.
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 REPORT THE
INCIDENT TO THE PROVIDER AND/OR THE MANUFACTURER. A SERIOUS INCIDENT IS DEFINEDAS AN INJURY, DEATH, OR POTENTIAL TO CAUSE
INJURY/DEATH SHOULD THERE BE A REOCCURRENCE OF THE INCIDENT. THE USER CAN ALSOREPORT THE INCIDENT TO THE COMPETENT AUTHORITY IN THE COUNTRY WHERE THE INCIDENTOCCURRED.

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.

8 - ENG PN MN250 J | User ManualFreeStyle Comfort
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.

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
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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FreeStyle Comfort
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: APPROVED OXYGEN DELIVERYACCESSORIES ARE DESIGNED TO REDUCE THE
PROPAGATION OF FIRE FOR THE SAFETY OF THE
PATIENT. USE OF UNAPPROVED ACCESSORIESMAY INCREASE THE RISK OF INJURY OR DAMAGE RELATED TO FIRES.
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 PRESENT A 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
CAUSE CANCER. FOR MORE INFORMATION, GO
TO WWW.P65WARNINGS.CA.GOV.

10 - ENG PN MN250 J | User Manual

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 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 isstarted 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
are using the Oxygen Concentrator unit is turnedoff, disconnect and remove the device from theautomobile. 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 effect medical electrical equipment.
CAUTION: DO NOT leave the Oxygen
Concentrator or the Power Supply
plugged into the vehicle if the ignition isin 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 affect performance and decrease battery
run time and/or increase battery charge time. Referto the Specifications section in this manual forstorage and operating temperature limits.
CAUTION: For Oxygen Concentrators equippedwith batteries: Store in a cool and dry location to
help ensure the longevity of your battery. Storing
your Oxygen Concentrator for extended periods oftime at high temperatures or with a fully charged
or completely discharged battery can degrade
its overall battery life. Do not attempt to open thebattery; there are no serviceable parts inside thebattery. 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.

FreeStyle Comfort
Note: To mitigate harm caused by concentrator or
power failure, equipment provider should assess
the need for back-up oxygen during installation andperiodically when these attributes change:-The condition of the patient-The environment in which the patient lives-The ability to resupply the patient with back-up
supplies of supplementary oxygen.
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).

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 thespecifications table, it should be allowed to return tonormal operating temperature before being poweredon.

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.

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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 STPD)
All Volumes +/- 15%

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> -0.5 cm H2O

AC Power

100–240 VAC, 50-60Hz

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

See Warranty Statement* 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. Warm up screen may continue to display until the concentrator has reached target
concentration or up to 15 minutes. Continue to use unit during this time.
The expected service life is a minimum of five years.

12 - ENG PN MN250 J | User Manual

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

PN MN250 J | User Manual ENG - 13

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.

Pulse Volume (mL)* Setting
Breath
Rate

1

2

3

4

5

15

14.0

28.0

42.0

56.0

70.0

20

10.5

21.0

31.5

42.0

52.5

25

8.4

16.8

25.2

33.6

42.0

30

7.0

14.0

21.0

28.0

35.0

35

6.0

12.0

18.0

24.0

30.0

40

5.3

10.5

15.8

21.0

26.3

*Tolerance is +/- 15%

A brief audible alarm will sound to indicate thedevice has powered on.

8. Turn the FreeStyle Comfort off by pressing thepower button.

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.

Note: The display screen will enter standby mode anddim after 20 seconds. Press any button to wake thescreen out of standby mode.

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.

14 - ENG PN MN250 J | User Manual

SPECIAL PRODUCT FEATURES

UltraSense®
This sensitive pulse dose trigger detects the pressure change during your breath, and releases thepulse 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.

Power Supplies
The FreeStyle Comfort can be powered in 3 ways:• 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 MN250 J | User Manual ENG - 15

FreeStyle Comfort
Note: If the power supply is attached, 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.

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.

BATTERY OPERATING DURATION

16 - ENG PN MN250 J | 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.

2. Connect the AC power cord to the AC power
brick.
The DC power supply consists of a cord that plugs
directly into the unit and the DC outlet.

AC POWER

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.

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

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.

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

PN MN250 J | User Manual ENG - 17

FreeStyle Comfort
3. Connect the opposite end of the DC power cord
to the automobile or other DC accessory outlet.

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.

4. Turn on the FreeStyle Comfort by pressing thepower button and select your prescribed flow
setting utilizing the increase (+) or decrease (-)
flow buttons.
CAUTION: To prevent possible fire or
overheating, ensure the 12V DC power
outlet is free of debris and the adapter
plug of the DC Power Supply fits properly and remains securely in place.
CAUTION: DC power supply metal surfaces canbecome VERY HOT when in use due to highcurrent. Allow sufficient time for surfaces to cool
before touching.
CAUTION: DO NOT USE THE DC POWER SUPPLYWITH ANY EXTENSIONS, SPLITTERS, OR ADAPTERS. USE OF UNAPPROVED ACCESSORIESMAY RESULT IN THEM OVERHEATING OR BEING
DAMAGED.
CAUTION: ATTACHING THE DEVICE TO A 12V DC
POWER OUTLET CAN DEPLETE THE VEHICLESBATTERY IF THE ENGINE IS NOT RUNNING, EVEN
IF THE DEVICE IS TURNED OFF.
CAUTION: DO NOT JUMP-START A VEHICLE
WHILE THE DC POWER SUPPLY IS CONNECTED.

18 - ENG PN MN250 J | User Manual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
the oxygen 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.

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.
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 gases. To prevent rust,
PN MN250 J | User Manual ENG - 19

FreeStyle Comfort
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.

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 (notwet) cloth or sponge. Spray the cloth or spongewith a mild disinfectant solution to clean the cabinet and power supplies. Proceed as directed by thecleaner 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 TOPREVENT THE OXYGEN CONCENTRATOR AND
THE BATTERY PACK FROM GETTING WET OR ALLOWING FLUIDS TO ENTER THE UNIT. THIS CANCAUSE A MALFUNCTION OR SHUT DOWN, AND
CAUSE AN INCREASED RISK FOR ELECTRICALSHOCK OR BURNS.
WARNING: DO NOT USE LIQUID DIRECTLY ON
THE UNIT. A LIST OF UNDESIRABLE CHEMICALAGENTS INCLUDES BUT IS NOT LIMITED TO THE
FOLLOWING: ALCOHOL AND ALCOHOL-BASEDPRODUCTS, CONCENTRATED CHLORINE-BASEDPRODUCTS (ETHYLENE CHLORIDE), AND OILBASED PRODUCTS. THESE ARE NOT TO BE USEDTO CLEAN THE PLASTIC HOUSING ON THE CONCENTRATOR, AS THEY CAN DAMAGE THE UNIT.
WARNING: CLEAN THE CABINET, CONTROLPANEL, 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 OUTLETFOR THE CANNULA CONNECTION TO MAKE
SURE IT REMAINS FREE OF DUST, WATER, AND
PARTICLES.

20 - ENG PN MN250 J | 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 BATTERY PACK HOUSING.
WARNING: DO NOT DISINFECT/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 asrecommended by the cannula manufacturer or youroxygen provider. Your physician or oxygen provider will provide you with cleaning and replacement
instructions.
Additional supplies for replacement are available
through your oxygen provider.

FreeStyle Comfort

Alarm Conditions
Priority #Alarm
Description

1

System
Malfunction
Battery Over
Temp

Display

AudibleSignalMore Details

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

System
Malfunction
High
Pressure(High System
Pressure orCompressor
Fault)

1 beepevery 20
sec

4

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

1 beepevery 30
sec

If problem persists, contact provider.

5

Low Battery
Shut Down

1 beepevery 30
sec

Alarms until battery runs out of power andunit shuts down.

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.

Charge battery.

PN MN250 J | User Manual ENG - 21

FreeStyle Comfort
Priority #Alarm
Description

6

No Breath
Detected

Display

AudibleSignalMore Details

1 beepevery
10 minNo breath detected for 15 seconds.
Activated after first breath or warm up
screen is off, whichever comes sooner.
Check cannula for kinks or leaks. If problem persists, contact provider.

7

Warm Up

none

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

8

Low
Concentration

1 beepevery
10 min,for up to
30 minIf problem persists, contact provider.

9

Low Battery
Warning

1 beep,no repeat

Charge battery.

10

Breathing
Rate
Exceeded

1 beep,no repeat

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.

22 - ENG PN MN250 J | User Manual

If problem persists, contact provider.

If problem persists, contact provider.

FreeStyle Comfort
Priority #Alarm
Description

Info

Start up

Display

AudibleSignalMore Details

1 infobeep

Screen displays at power-on and you
should hear one beep to confirm buzzer isfunctioning
Start up screen display current firmware
revision in bottom right corner.

Info

Normal Run
Screen (noDC Powerconnected)

none

Info

SettingChanged

1 infobeep

InfoPlug inexternal
Power in theoff condition

none

Info

Plug inexternal
power in the
run condition

none

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

PN MN250 J | User Manual ENG - 23

FreeStyle Comfort
Priority #Alarm
Description

Info

AudibleSignalMore Details

Unplugexternal
power in theoff Condition

1 infobeep

Display CAIRE screen for 2 seconds andthen turn display off.

Info

Unplugexternal
power in the
run Condition(with battery
present)

1 infobeep

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

24 - ENG PN MN250 J | User Manual

Display

Screen will display for 5 sec then turn off

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.

PN MN250 J | User Manual ENG - 25

FreeStyle Comfort

Travel Information

ACTIVATE AIRPLANE MODE

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.

Battery Power
POC can be used on an aircraft per normal operating procedures using Battery Power ONLY, whenno external power source is connected

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).

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

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.

2. Enable Airplane Mode - Press and hold both Up
and Down buttons for 5 seconds until you hear along beep and see the Airplane symbol appear.

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

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

26 - ENG PN MN250 J | User Manual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

Carrying Bag Instructions

1. Shoulder strap can be attached to either the unit
directly or the carrying bag.

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

2. Clip strap onto the ring on the unit or bag.

PN MN250 J | User Manual ENG - 27

FreeStyle Comfort

DisposalAlways 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
This symbol is to remind the equipment
owners to return it to a recycling facility at the

CAUTION: For proper disposal,
contact your equipment provider or
local government agency for disposal
instructions
CAUTION: Always dispose of molecular sieve inaccordance with all federal, state, and local environmental control regulations.

Materials 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 61000-3-3
28 - ENG PN MN250 J | User ManualComplianceElectromagnetic 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.

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.

PN MN250 J | 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 – 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.

30 - ENG PN MN250 J | User Manual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.

• 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.

PN MN250 J | User Manual ENG - 31

www.c a ire inc .c om

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
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Serfontana 106834 Morbio Inferiore
Switzerland
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 2024 CAIRE Inc. All Rights Reserved. CAIRE Inc. reserves the rightto 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 or consequence. All rights not expressly
stated herein are reserved by us, as applicable.

|MN250-J'~

10 September 2024

PN MN250 J