FreeStyle® Comfort®
Portable Oxygen Concentrator with autoSat ®, UltraSense®, and autoDOSE™

Technical Manual (English) MN242 C

FreeStyle Comfort
User Controls & System Status Indicator

This manual is applicable only for FreeStyle Comfort units
equipped with the 4-button user interface and firmware
version 2.7 or higher.
Reference MN233 for older models.
ISO 7000: graphical symbols for use on
equipment – Index and synopsis
Read user’s manual before
operation. Reg. #1641

Keep away from open flame, fire,
sparks. Open ignition source andsmoking prohibited. Reg. #P003
Type BF applied part (degree ofprotection against electric shock)Reg. #5333
Warning. Reg. #W001

Storage or operating temperature
range. Reg. # 0632

Storage humidity range Reg. #2620

Council Directive 93/42/EEC: concerning
medical devices
Authorized representative in
the European Community.
If the product unique device
identifier (UDI) label has theCE#### symbol on it, thedevice complies with therequirements of Directive
93/42/EEC concerning
medical devices. The CE####symbol indicates notified
body number.

Atmospheric pressure limitation.
Reg. #2621
Name and address ofmanufacturer. Reg. #3082
Date of manufacturer. Reg. #2497
Catalog Number. Reg. #2493
Serial Number. Reg. #2498

IEC 60417
Class II Equipment, Double
Insulated. Reg. #5172

This way up. Reg #0623
Fragile, handle with care. Reg.
#0621

Power Switch. Reg. #5009
ETL Certification
Safety agency for CAN/CSA
C22.2 No.601.1 M90 for
medical electrical equipment.

Keep away from rain, keep dry.
Reg. #0626
Stacking limit by number. Reg.
#2403
ISO 7010: Graphical symbols – Safety colors
and safety signs – Registered safety signs
The instruction manual must be
read. Reg. #M002
Do not smoke near unit or while
operating unit. Reg. #P002

Internal Symbols
Keep away from flammablematerials, oils, and grease.
Do not disassemble.
Increase flow.
Decrease flow.

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Menu button.
RTCA DO160 Section 21
Category M Compliant. FAA
SFAR 106 requirement
FAA Approved - POC
21 CFR 801.15: Code of Federal Regulations
Title 21
Federal law restricts thisdevice to sale by or on theorder of a physician
IEC 60601-1: Medical electrical equipment Part
1 General requirements for basic safety andessential performance
Drip proof.

FCC NOTICE:
This 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 formodular transmitter approval as detailed in FCC
public Notice DA00-1407. Transmitter operation
is subject to the following two conditions (1) This
device may not cause harmful interference, and(2) This device must accept any interference
received, including interference that may cause
undesired operation.
This product may be covered by one or more
patents, US and international. Please visit our
website below for the listing of applicablepatents.
Pat.: www.caireinc.com/corporate/patents/

Council Directive 2012/189/EU: waste electricaland electronic equipment (WEEE)
WEEE

Contains FCC ID: WAP 2001
FCC Notice3

MN242 Rev C

FreeStyle Comfort
Table of Contents
User Controls & System Status Indicator .......................................................................... 2
FreeStyle Comfort Overview ............................................................................................. 5
Description of Operation.................................................................................................... 7
Safety Instructions ............................................................................................................. 8Specifications ................................................................................................................... 13
Test Procedures ................................................................................................................ 14
Test Mode Operation ....................................................................................................... 16
Verify AC and DC Operation .......................................................................................... 17
Menu Navigation Instructions .......................................................................................... 18
Travel Information ........................................................................................................... 21
Patient Cleaning, Care and Routine Maintenance ............................................................ 22
Equipment Provider Maintenance .................................................................................... 24
Recording Maintenance ................................................................................................... 26
Service Procedures ........................................................................................................... 27
Troubleshooting ............................................................................................................... 28
Troubleshooting Table ..................................................................................................... 29
Accessories and Parts List................................................................................................ 33
Notes ................................................................................................................................ 34

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FreeStyle Comfort
FreeStyle Comfort Overview
Front View
Strap Attachment

User Interface

Oxygen Outlet
Air Outlet

Air Intake / Filter

Battery Pack

Power Port
Receptacle Tab

Battery Pack
Release Button

Increase Setting
Power Button

Decrease Setting

5

Menu Button

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Display Screen on Battery

Flow Setting

Battery Display

autoSAT Indicator

Bolus Delivery Indicator

Battery
Percentage
Remaining

Alarm Display
Space

Display Screen On AC/DC Power

Charge Indicator

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Description of Operation
The air we breathe contains approximately 21% oxygen, 78% nitrogen, and 1% other gasses. In the FreeStyle
Comfort, room air is drawn into the machine through the air intakes. It then passes through an adsorbent material
called molecular sieve. This material separates the oxygen from the nitrogen and allows only the oxygen to 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 beginning of each inhalation. Pulse flow
delivery is ideal for activities and time away from home. It conserves oxygen and extends battery life as opposed
to continuous flow. The FreeStyle Comfort is lightweight enough to be carried via the handle, shoulder strap, orbackpack. It can be operated on AC, DC (vehicle) or battery power.

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Safety Instructions
Safety instructions are defined asfollows:
WARNING: IMPORTANT SAFETYINFORMATION FOR HAZARDS THATMIGHT CAUSE SERIOUS INJURY.
CAUTION: Important information forpreventing 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 A PHYSICIAN OR OTHER LICENSED HEALTH
CARE PROVIDER.
WARNING: THIS UNIT IS NOT TO BE USED FOR
LIFE SUPPORT. GERIATRIC, PEDIATRIC, OR
ANY OTHER USER UNABLE TO COMMUNICATEDISCOMFORT WHILE USING THIS DEVICE MAY
REQUIRE ADDITIONAL MONITORING. USERSWITH HEARING AND/OR SIGHT IMPAIRMENT(S)
MAY NEED ASSISTANCE WITH MONITORING
ALARMS.
WARNING: PULSE DOSE MODE SETTINGSMUST BE DETERMINED FOR EACH USERINDIVIDUALLY FOR THEIR NEEDS AT REST,
DURING EXERCISE, AND WHEN TRAVELING.
WARNING: SOME RESPIRATORY EFFORTS OF
THE PATIENT MIGHT NOT TRIGGER THE
CONVERSERING FUNCTION WARNING: THE
FREESTYLE COMFORT IS NOT INTENDED FOR
USE WITH A TRACHEOTOMISED PATIENTWARNING: PREGNANT OR NURSING WOMENSHOULD NOT USE ACCESSORIESRECOMMENDED IN THIS MANUAL, THEY MAY
CONTAIN PHTHALATES.

8

Contraindications for Use
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 EXPERIENCE ADVERSE HEALTH CONSEQUENCES AS THE
RESULT OF SUCH TEMPORARY INTERRUPTION.

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: 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 ALSO REPORT THE INCIDENT TO
THE COMPETENT AUTHORITY IN THE COUNTRY
WHERE THE INCIDENT OCCURRED.

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WARNING: THE USE OF SOME OXYGEN ADMINISTRATING ACCESSORIESNOT SPECIFIED FOR THIS OXYGENCONCENTRATOR MAY IMPAIR ITSPERFORMANCE. RECOMMENDED ACCESSORIES ARE REFERENCED
WITHIN THIS MANUAL.

WARNING: DO NOT ALLOW EITHER THE AIRINTAKE OR THE AIR OUTLET EXHAUST TO
BECOME BLOCKED. DO NOT DROP OR INSERTANY OBJECTS INTO ANY OPENINGS ON THE
DEVICE. THIS CAN CAUSE THE OXYGENCONCENTRATOR TO OVERHEAT AND IMPAIRPERFORMANCE.

WARNING: IF THE OXYGEN CONCENTRATOR
HAS BEEN DROPPED, DAMAGED OR EXPOSEDTO WATER, PLEASE CONTACT YOUR HOME
CARE PROVIDER FOR INSPECTION OR POSSIBLE
RE- PAIR OF THE DEVICE. DO NOT USE THE
OXYGEN CONCENTRATOR IF IT HAS A DAMAGEDPOWER CORD OR PLUG.

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 DAMAGEDBATTERY MAY CAUSE PERSONAL INJURY.

WARNING: PROPERLY SECURE, BELT OR
OTHER- WISE RESTRAIN THE OXYGENCONCENTRATOR 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 PROVIDERBEFORE ATTEMPTING 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 MANUALFOR TEMPERATURE LIMITS.

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 PORTABLEOXYGEN CONCENTRATOR OUTDOORS WITH
THE AC POWER SUPPLY, CONNECT THE POWER
SUPPLY INTO 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 MEDICALELECTRICAL EQUIPMENT AS REPLACEMENTPARTS FOR INTERNAL COMPONENTS, MAY
RESULT IN INCREASED EMISSIONS OF
DECREASED IMMU- NITY OF THE OXYGENCONCENTRATOR.
WARNING: USE ONLY ELECTRICAL VOLTAGE
SPECIFIED ON THE SPECIFICATION LABEL AFFIXED TO THE DEVICE.

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
LOTIONS OR SALVES SHOULD BE USED.
OXYGEN ACCEL- ERATES THE COMBUSTION OF
FLAMMABLE SUBSTANCES.

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WARNING: DO NOT USE EXTENSION CORDSWITH THIS UNIT OR CONNECT TOO MANY PLUGSINTO THE SAME ELECTRICAL OUTLET. THE USE
OF EXTENSION CORDS COULD ADVERSELY
AFFECT THE PERFORMANCE OF THE DEVICE.
TOO MANY PLUGS INTO ONE OUTLET CANRESULT IN AN OVERLOAD TO THE ELECTRICALPANEL CAUSING THE BREAKER/FUSE TO
ACTIVATE OR FIRE IF THE BREAKER OR FUSEFAILS TO OPERATE.
CAUTION: In the event of an alarm or
you observe the Oxygen Concentrator is
not working properly; consult the
Troubleshooting section in this manual.
If you cannot resolve the problem,
consult your Equipment Provider.
CAUTION: To prevent a void warranty, follow all
manufacturer’s instructions.
WARNING: DO NOT ATTEMPT ANY
MAINTENANCE OTHER THAN THE
POSSIBLE SOLUTIONS LISTED WITHIN
THIS MANUAL. DO NOT REMOVE
COVERS, ONLY YOUR EQUIPMENTPROVIDER OR A QUALIFIED SERVICETECHNICIAN SHOULD REMOVE THE
COVERS OR SERVICE THIS DEVICE.
WARNING: USE ONLY ACCESSORIESRECOMMENDED BY THE MANUFACTURER. USE
OF ANY OTHER MAY BE HAZARDOUS, CAUSESERIOUS DAMAGE TO YOUR OXYGENCONCENTRATOR 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: SMOKING WHILE USING OXYGEN IS
THE NUMBER ONE CAUSE OF FIRE INJURIESAND RELATED DEATHS. YOU MUST FOLLOWTHESE SAFETY WARNINGS:WARNING: DO NOT ALLOW SMOKING, CANDLES, OR OPEN FLAMES IN THE SAME ROOMWITH THE DEVICE OR THE OXYGEN-CARRYINGACCESSORIES.

WARNING: IF YOU SMOKE, THESE 3 STEPS MAY
SAVE YOUR LIFE: TURN OFF THE OXYGENCONCENTRATOR, TAKE OFF THE CANNULA,
AND LEAVE THE ROOM WHERE THIS DEVICE IS
LOCATED.
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, BODILYINJURIES OR DEATH.
WARNING: REMOVING THE CANNULA AND
PUTTING IT ON CLOTHING, BEDDING, SOFAS,OR OTHER CUSHION MATERIAL WILL CAUSE A
FLASH FIRE WHEN EXPOSED TO A CIGARETTE,HEAT SOURCE, OR FLAME.
WARNING: DO NOT LEAVE A NASAL CANNULA
ON OR UNDER CLOTHING, BED COVERINGS OR
CHAIR CUSHIONS. IF THE UNIT IS TURNED ON
BUT NOT IN USE, THE OXYGEN WILL MAKE THE
MATERIAL FLAMMABLE. ENSURE THE POWER IS
OFF WHEN THE OXYGEN CONCENTRATOR IS
NOT IN USE.
WARNING: THE OXYGEN CONCENTRATOR MUSTBE OFF AND DISCONNECTED FROM EXTERNALPOWER BEFORE REMOVING THE BATTERYPACK.
CAUTION: Always disconnect AC power
supply from the wall before
disconnecting the AC power supply fromthe Oxygen Concentrator.
CAUTION: Do not position the Oxygen
Concentrator so that it is difficult to access thepower cord.

CAUTION: Always place oxygen supply tubing andpower cords in a manner that prevents trip hazard
or possible accidental strangulation.

WARNING: SMOKING WHILE WEARING ANOXYGEN CANNULA MAY CAUSE FACIAL BURNSAND POSSIBLY DEATH.

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WARNING: SMALL PARTS MAY
PRESENT A POTENTIAL CHOKING
HAZARD.
WARNING: AVOID CONTACT WITH EXHAUSTAIR VENT FOR LONGER THAN 10 SECONDS AS
IT MAY BE WARM.
WARNING: WIND OR STRONG DRAUGHTS CANADVERSELY AFFECT ACCURATE DELIVERY OF
OXYGEN THERAPY.

CAUTION: When using the Oxygen Concentrator in
an automobile, boat, or on other DC sources with
the DC power supply, make sure that the vehicle isstarted and running before connecting the Oxygen
Concentrator. If the DC power supply does notilluminate and requires resetting, disconnect the
DC power supply from the DC outlet, restart yourvehicle, and then reconnect your DC power supply
into the DC outlet. Failure to follow these
instructions can result in the power supply notsupplying 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 theautomobile. Do not store the Oxygen Concentrator
in a very hot or cold automobile or in other similar,
high- or low-temperature environments.

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: 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 orcompletely discharged battery can degrade its
overall battery life.
Do not attempt to open the battery; there are noserviceable parts inside the battery. Keepbatteries away from children.
CAUTION: ONLY USE the Manufacturer’s provided
batteries. For proper battery disposal, contact
your Equipment Provider or your local
government agency for disposal requirements.
CAUTION: Operating or storing the Oxygen
Concentrator Outside of its normal operating
temperature range and ambient pressure range.
(altitude) can affect performance and decrease
battery run time and/or increase battery charge
time.
Refer to the Specifications section in this manual
for storage and operating temperature limits.

Note: Portable and mobile RF communications
equipment can affect medical electrical equipment.
WARNING: THIS PRODUCT CAN EXPOSE YOU TOCHEMICALS INCLUDING NICKEL, WHICH IS
KNOWN TO THE STATE OF CALIFORNIA TO
CAUSE CANCER. FOR MORE INFORMATION, GO
TO WWW.P65WARNINGS.CA.GOV.

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Note: Ensure the cannula is fully inserted andsecure. This ensures that the Oxygen Concentrator
can properly detect inspiration for oxygen delivery.
During inhalation, you should hear or feel oxygen
flow to the prongs of the nasal cannula.
Note: Lithium batteries may permanently lose
capacity when exposed to extremely hottemperatures with the batteries fully charged orcompletely depleted. For extended storage, it isrecommended that batteries be charged 25 to 50%
and remain within a temperature range of 73°F ±35°F (23°C ± 2°C).
Note: The use of some oxygen administration
accessories not specified for use with this oxygen
concentrator may impair its performance.
Recommended accessories are referenced within
this manual.
Note: Do not operate the Oxygen Concentrator
without the air intake filter in place. If a second
filter is provided, insert the replacement filter
before you clean the dirty filter. Clean the dirty
filter in a warm soap and water solution, then dry
thoroughly prior to use.
Note: The Manufacturer does not recommend thesterilization of this equipment.
Note: There is never a danger of depleting theoxygen in 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 shownin the table below, it should be allowed to return tonormal operating temperature before being
powered on.

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Specifications
FreeStyle Comfort
Dimensions (with Single Battery)

10.0 x 7.3 x 3.1 in (25.4 x 18.5 x 7.9 cm)

Dimensions (with Double Battery)

11.0 x 7.3 x 3.1 in (27.9 x 18.5 x 7.9 cm)

Weight (with Single Battery Pack)

5 lbs. (2.3kg)

Weight (with Double Battery Pack)

6 lbs. (2.7kg)

Nominal Sound Level

39,93 dB(A) ± 0,42 dB(A) @ 2

Flow Settings

Pulse Setting 1, 2, 3, 4, 5

O2 Output Setting

Setting 1 - 210 mL/min
Setting 2 - 420 mL/min
Setting 3 - 630 mL/min
Setting 4 - 840 mL/min
Setting 5 - 1050 mL/min

Oxygen Concentration*
Oxygen Monitor

90% (+5.5% / -3%)
Yes

Maximum Outlet Pressure< 30PSI

Default Dosing Sensitivity> -0.1 cmH2O (adjustable)

Length of Cannula

7 ft. (2.1 m)

AC Power

100-240VAC, 50-60Hz

DC Power

11-18 VDC (10 max amp)

Battery Type

Lithium Ion

Battery Capacity
Battery Re-Charge Time

Single cell: 6700 mAh
Double cell: 13400 mAh
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)
Transportation and Storage Temp.
(Battery)-13°F to +158°F (-25°C to +70°C) up to 10,000 ft. (3048m)

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

Operating Humidity

15-95% relative humidity (non-condensing)

Limited Warranty

3 years unit
1 year battery & power supplies-13°F to +158°F (-25°C to +70°C) up to 10,000 ft. (3048m)* 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. The warm-up screen may continue to display until the concentrator has
reached target concentration or up to 15 minutes. Continue to use the unit during this time.
*** 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 us unused during the entire period.

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Test Procedures

3.

Insert the AC or DC power supply into thepower port receptacle on the front, bottom
right side of the unit.

4.

Connect a nasal cannula to the oxygen outlet
barb. Ensure the connection is secure before
the operation.

Verify General Operation
1.

Locate and position the FreeStyle Comfort ina proper location for use.
a. The concentrator should be well-ventilated
so that the air intake filters and air outlet are
not obstructed.
b. The concentrator should be positioned sothat all audible and visual indicators andalarms can be easily seen and heard.
c. Be sure the air intake filters are in place
before operating the unit. If the unit ismissing a filter, contact your equipment
provider.

2.

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

NOTE: Any Cannula(s) used other than therecommended may affect performance.

5.

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

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

A brief audible alarm will sound to indicate thedevice has powered on. A start-up screen will appear
showing the current firmware revision in the bottom
right corner.

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autoSAT Pulse Volume (mL) * Setting
Breath 1
2
3
4
5
Rate
15
10.5 21.0
31.5
42.0
52.5
20
10.5 21.0
31.5
42.0
52.5
25
10.5 21.0
31.5
42.0
42.0
30
10.5 21.0
31.5
35.0
35.0
35
10.5 21.0
30.0
30.0
30.0
40
10.5 21.0
26.3
26.3
26.3
Note: When the Freestyle Comfort is initiallyturned on the default flow setting is 2. If thesetting is changed, the unit will power on to
the previous flow setting.
Next, the warm-up screen will display while theoxygen concentration is increased until it exceeds
low concentration threshold or up to 15 minutes
whichever is sooner. Also, the FreeStyle Comfort
will start by auto-dosing until a breath is detected or
warmup ends, whichever is sooner.

Non-autoSAT Pulse Volume (mL) * Setting
Breath 1
2
3
4
5
Rate
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%

6.

7.

Position the nasal cannula on your face per
the manufacturer’s instructions provided withthe cannula and breathe normally. You should
feel a puff of oxygen delivered through thenasal cannula each time you inhale.
To change the flow setting, press the increase(+) or decrease (-) flow buttons to the desired
flow rate. It is normal to hear a difference insound as you change the flow settings.

8.

Turn the FreeStyle Comfort off by pressing
the power button.

9.

For Advanced Features see Menu Navigation
Instructions.

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

Note: To Equipment Provider: The following
oxygen administration accessories arerecommended 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• Firebreak: CAIRE Part Number 20629671
A firebreak is recommended for use with any
cannula.
• CAIRE offers a firebreak intended to be usedin conjunction with the oxygen concentrator.
The firebreak is a thermal fuse to stop the flowof gas in the event that the downstream cannulaor oxygen tubing is ignited and burns to thefirebreak. It is placed in-line with the nasal
cannula or oxygen tubing between the patient
and the oxygen outlet of the FreeStyle
Comfort. For proper use of the firebreak,always refer to the manufacturer’s instructions(included with each firebreak kit).
• For any additional recommended accessories,
please see the Accessories Catalog (PN
MLLOX0010) available on www.caireinc.com.

15

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FreeStyle Comfort
Special Product Features
autoSAT®
This feature adjusts oxygen concentrator performance
to guarantee the prescribed amount of oxygen isdelivered with each breath.

Alarm Code in Test Mode
Reviewing the Alarm Code may be useful during thetroubleshooting. The unit will enter an auto-pulse
mode for testing such as oxygen level:1.

To check the Alarm Code, turn the unit on
and enter the Test Mode per instruct from theprevious section.

2.

On the top of the screen, the four-digit
number indicates the operating status of theunit. Any combination beside 0000 will
indicate the specific issue of the unit. Refer to
TROUBLESHOOTING IN TEST MODE for
details.

UltraSense®
This sensitive pulse dose trigger detects the pressurechange during your breath, and releases the pulse ofoxygen 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.

Test Mode Operation
Entering Test Mode
With the unit turned on, press the following
sequence of buttons “+ + - - + - + -”. For the unit torecognize the following sequence, it has to beentered within a 5 second period. If the sequence of
buttons is entered correctly, the unit will alarm andthe screen will change, having a red border aroundthe screen, indicating the unit is now in test mode.
The unit will begin auto-pulsing, enabling O2
concentration testing.

O2 Concentration Test

To exit test mode, turn off the unit or re-enter thetest mode sequence. Be sure to exit test mode before
returning the unit to patient use.

Before reviewing the Troubleshooting Chart, thefollowing steps may be useful to identify any
malfunctions:
1.

Make sure all filters are clean.

Hour Meter

2.

Enter the Test Mode per instruct from theprevious section. After ten minutes ofrunning in test mode, measure the oxygen
concentration. The acceptable O2 range is
90% oxygen +5.5/-3%.

The hour meter will be useful for tracking the usageof the unit and plan the provider maintenance:
1.

To view the total operating hours, turn theunit on and enter Test Mode per the
instruction from the previous section.

2.

Within the Test Mode, the five-digit number
shown at the bottom of the screen (next to thehourglass symbol) is the operating hours of
the unit.

16

Note: The pulse setting can be increased or
decreased as normal operation while in test
mode.
3.

To exit test mode, turn off the unit or re-enter
the test mode sequence. Be sure to exit test
mode before returning the unit to patient use.

MN242 Rev C

FreeStyle Comfort
Verify AC and DC Operation
The FreeStyle Comfort comes with an AC and DC
power supply to keep your concentrator powered
wherever you go.
The AC power supply includes the following:a.

AC Power brick that operates between 100240 volts, 50-60Hz.
b. AC Power cord to connect to the power brickand 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.

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

Verify AC Power Operation
AC power is for use at home or wherever standard AC
outlet power is available. The FreeStyle Comfort isfully functional on AC power. The FreeStyle Comfort
will also recharge the battery pack if needed any time
AC power is available (except in an airplane). The
battery pack will recharge whether the FreeStyle
Comfort is powered on or off.

WARNING: DO NOT CONNECT
EXTERNAL POWER WITHOUT A
BATTERY PACK INSTALLED IN THE
OXYGEN CONCENTRATOR.
To connect the FreeStyle Comfort to AC Power:
1. Connect the AC power brick to the power
connector inlet on the front, right bottom of the
FreeStyle Comfort. Be sure to push inward, so
the connection is secure.

17

4. Connect the AC power brick to the power
connector inlet on the front, right bottom of the
FreeStyle Comfort. Be sure to push inward sothat the connection is secure.
5. Turn on the FreeStyle Comfort by pressing thepower button and increase (+) or decrease (-)
the pulse setting.
6. Verify unit operates properly in all settings.
Note: If the battery pack needs to berecharged, the battery icon on the display will
have a single orange bar.

MN242 Rev C

FreeStyle Comfort
Verify DC Power Operation
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 thebattery 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 OXYGENCONCERTRATOR.
1. Turn on your motor vehicle.

Menu Navigation Instructions
You can enter the Menu in Standby or Run mode. In
Run Mode, if an alarm condition occurs the menu willautomatically be exited. If no buttons are pressed 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 revision number,run time, and battery discharge cycles.
2. Airplane mode (ON/OFF)
3. Sensitivity: adjustable (1-5)
4. autoSAT (ON/OFF)

Note: Never operate the unit without thevehicle running.
2. Connect the DC power supply to the power port
receptacle front, bottom right side of the FreeStyle
Comfort. Be sure to push inward so that the connection
is secure.

Example Status Screen
To scroll through the menus, push the Decrease
Button.
3. Connect the opposite end of the DC power cord to
the automobile or other DC accessory outlet.

StatusThis screen will display the run time in hours, thebattery discharges, and the firmware revision number.

4. Turn on the FreeStyle Comfort by pressing thepower button and select your prescribed flow setting
utilizing the increase (+) or decrease (-) flow buttons.
5. Verify that unit operates properly in all settings.
Note: If the battery pack needs to berecharged, the battery icon on the display will
have a single orange bar.

18

Status Page

MN242 Rev C

FreeStyle Comfort
Airplane Mode
The FreeStyle Comfort ships with Airplane Modeturned off.

Pressing the Decrease Button when the screen shows
the NEXT symbol will move the menu page to thenext 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 ModeTo turn the mode on, press the Increase Button while
the CHANGE icon is visible. The value will toggle tothe blue word “ON”.

The FreeStyle Comfort ships with a default
Sensitivity Mode setting of 3 from the factory andshould not require adjustment under normal
conditions. Sensitivity Setting can be adjusted
between values 1-5, where 1 is the least sensitive, and
5 is the most sensitive.

Airplane Mode: On Selected

Sensitivity Mode Screen at Setting 2

Airplane Mode Main Screen

To confirm Airplane Mode on, press the Decrease
Button while the SAVE icon is visible. The value will
toggle to the black word “ON”.
To cancel Airplane Mode on, press the Menu Button
while the CANCEL icon is visible.

To adjust the Sensitivity Mode, press the Increase
Button while the CHANGE icon is visible. The value
will toggle to the next blue number.

Sensitivity Mode Setting 3 Selected
Airplane Mode: On Confirmed
To turn Airplane Mode off, repeat above while
toggling to OFF.

19

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

MN242 Rev C

FreeStyle Comfort
To cancel the Sensitivity Mode change, press the
Menu Button while the CANCEL icon is visible.

Sensitivity Mode Setting 3 Confirmed

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

autoSAT Mode OFF Selected
To confirm autoSAT Mode off, press the Decrease
Button while the SAVE icon is visible. The value will
toggle to the black word “OFF”.
To cancel autoSAT Mode on, press the Menu Button
while the CANCEL icon is visible.

Sensitivity Mode Setting 5 (Max) Confirmed
Pressing the Decrease Button when the screen shows
the NEXT symbol will move the menu page to thenext screen option.

autoSAT Mode
The FreeStyle Comfort ships with autoSAT Modeturned on.

autoSAT Mode Off Confirmed
To turn autoSAT Mode on, repeat above while
toggling to ON.
Pressing the Decrease Button when the screen showsthe “Next” symbol will move the menu page to thenext screen option

autoSAT Mode Main Screen20

MN242 Rev C

FreeStyle Comfort
Travel Information

1. Turn the POC on using Battery Power ONLY,
when no external power source is connected.

The FreeStyle Comfort meets FAA guidelines for use
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 traveling witha FreeStyle Comfort.
It is suggested to always carry extra batteries with you
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 at least
150% of the expected maximum trip duration (flighttimes, ground time before and after the flight,
connections, and unexpected delays).
Note: If flying, it is recommended that extra
batteries are carried on in a secure carryingbag.

2. Enable Airplane Mode using one of the following
methods:
a. Follow directions to enable Airplane Mode in
Menu Navigation Instructions section.
b. Press and hold both the Increase and Decrease
buttons for 5 seconds until you hear a long beepand see the Airplane symbol appear.

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.

Activate Airplane Mode

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

Battery Power
POCs can be used on an aircraft per normal operatingprocedures using Battery Power ONLY, when no
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 back up to POC
batteries. In this case, the following recommended
procedure regarding the transition from battery toaircraft electrical power must be followed:
Note: Due to aircraft limitations, the batteries
do not charge in Airplane Mode.

21

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FreeStyle Comfort
Patient Cleaning, Care & Routine
MaintenanceRoutine Maintenance
Servicing of internal components inside of the cabinetof the FreeStyle Comfort must be performed by theoxygen provider.
The operator of the unit is responsible for the following
maintenance procedures.
• 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 A QUALIFIED SERVICETECHNICIAN.

Air Intake Filters
Air enters the FreeStyle Comfort through air intake
filters located on the front, bottom of the oxygen
concentrator. These filters prevent dust and other large
particles in the air from entering the unit.
At least once per week, the air intake filters should becleaned. Your oxygen provider may advise you toclean them more frequently, depending upon theoperating conditions. Follow these steps to clean the air
intake filters properly.

1. Remove the filters from the front of the FreeStyle
Comfort by pushing up on the corresponding tab andpulling outward.

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 Duration
Setting Single (8-cell)
Battery Duration
1
Up to 8 hours
2
Up to 4 hours
3
Up to 3 hours
4
Up to 2.25 hours
5
Up to 2 hours

Double (16-cell)
Battery Duration
16 hours
8 hours
6 hours
4.5 hours
4 hours

Battery Service LifeThe FreeStyle Comfort batteries are designed to last
300 charge/discharge cycles.

2. Wash the 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 arecompletely dry before reattaching.
4. Re-install the clean, dry filters.
WARNING: DO NOT OPERATE THE
OXYGEN CONCENTRATOR WITHOUTTHE AIR INTAKE FILTER IN PLACE.

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FreeStyle Comfort
Battery Pack Storage
The oxygen concentrator battery does not need to be
fully discharged before recharging. It is recommended
to charge the oxygen concentrator battery after eachuse.
Do not leave the battery in a location exposed toexcessive heat, such as in direct sunlight or 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 such as rapid
fluctuations in the ambient temperature.
For storage of a month or more, a discharged or
partial charged state of charge between 50% and 75%(two to three LEDs) is recommended. Once charged,
remove the battery from the oxygen concentrator.

Battery Disposal
Your battery is rechargeable and can be recycled. You
can also contact your local city or town offices for
instructions on proper disposal of the battery.

Cleaning
Turn OFF the unit and disconnect from AC or DC
power before any cleaning or disinfection. DO NOT
spray the outer case directly. Use a damp (not wet)cloth or sponge. Spray the cloth or sponge with a mildhousehold cleaner to clean the cabinet and power
supplies. Proceed as directed by the cleaner
manufacturer.

WARNING: TURN OFF THE UNIT AND
DISCONNECT THE POWER CORD
FROM THE ELECTRICAL OUTLETBEFORE YOU CLEAN THE UNIT TO
PREVENT ACCIDENTAL ELECTRICALSHOCK AND BURN HAZARD. ONLYYOUR EQUIPMENT PROVIDER ORA QUALIFIED SERVICE TECHNICIANSHOULD REMOVE THE COVERS ORSERVICE 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. THISCAN CAUSE A MALFUNCTION OR SHUT DOWN,
AND CAUSE AN INCREASED RISK FOR
ELECTRICAL SHOCK OR BURNS.
WARNING: DO NOT USE LIQUID DIRECTLY ON
THE UNIT. A LIST OF UNDESIRABLE 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 LIQUIDTO 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.
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.

23

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FreeStyle Comfort
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, three months)
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.

2. While using the oxygen outlet Spanner and a½” nut driver, unscrew oxygen outlet on thefront top right of the unit.

Additional supplies for replacement are available
through your oxygen provider.

Equipment Provider MaintenanceRequired Tools
 T6 torx driver

3. Once the oxygen outlet is removed, theproduct filter can be taken out by simply
tipping the FreeStyle Comfort to its side, andthe filter will disengage from its position.

 T8 torx driver

4. Insert the new product filter.

 ½” hex driver

5. Screw the oxygen outlet back until it feelssnug.

 Cannula barb tool (CAIRE P/N 21168706)

Air Intake Filter
The external air intake filter is located on the front,
bottom of the oxygen concentrator. You can easily
remove it by hand. Instruct the patient to clean thisfilter weekly. (Reference Air Intake filters in thecleaning, care and Routine maintenance section of thismanual.

WARNING: TURN OFF THE UNIT AND
DISCONNECT THE POWER CORD FROMTHE ELECTRICAL OUTLET BEFORE YOU
CLEAN THE UNIT TO PREVENT
ACCIDENTAL ELECTRICAL SHOCK AND
BURN HAZARD.
REMOVE THE BATTERY FROM THE UNIT
BEFORE PERFORMING ANY MAINTENANCE TO
PREVENT ACCIDENTAL ELECTRICAL SHOCK
AND BURN HAZARD. THE FREESTYLE COMFORTMUST BE OFF AND DISCONNECTED FROMEXTERNAL POWER BEOFRE REMOVING THE
BATTERY PACK.

Compressor Intake Filter
The Compressor Intake Filter is designed to last thelife of the unit when the unit is being used undernormal operating conditions. The filter is locatedunderneath the unit.
If the filter is needing to be replaced, remove thescrews using a T6 torx driver. Replace with a newcompressor intake filter.

Product Filter Replacement
The product filter is designed to last the life of theunit when being used under normal operating
conditions. If it is determined the product filter needs
to be replaced, follow the instructions below:
1. Turn the unit off, disconnect the power cord
and remove the power supply.

24

MN242 Rev C

FreeStyle Comfort
Cleaning and Preparing for New Patient
Use
When you remove the FreeStyle Comfort from apatient’s home, always detach and dispose of the usednasal cannula. Clean the exterior of the unit with amild household cleaner applied with a damp cloth orsponge. Pay special attention to the oxygen outlet forthe cannula connection to make sure it remains free of
dust, water, and particles. Be careful not to get any
liquid into the interior of the unit.
Next, clean the exterior with a common chemical
disinfectant before any other patient uses the unit. Do
not use liquid directly on the unit to clean it.

WARNING: TURN OFF THE UNIT,DISCONNECT THE POWER CORD FROMTHE ELECTRICAL OUTLET BEFORE YOU
CLEAN THE UNIT TO PREVENT
ACCIDENTAL ELECTRICAL SHOCK AND
BURN HAZARD.
REMOVE THE BATTERY FROM THE UNIT BEFOREPERFORMING ANY MAINTENANCE TO PREVENT
ACCIDENTAL ELECTRICAL SHOCK AND BURN
HAZARD. THE FREESTYLE COMFORT MUST BE
OFF AND DISCONNECTED FROM EXTERNALPOWER BEOFRE REMOVING THE BATTERYPACK.

CAUTION: DO NOT USE LIQUIDCOMFORT UNIT TO CLEAN IT. A
LIST OF UNDESIRABLE CHEMICALAGENTS INCLUDES BUT IS NOTLIMITED TO THE FOLLOWING,
ACCORDING TO THE PLASTICS
MANUFACTURER: ALCOHOL AND
ALCOHOL-BASED PRODUCTS,
CHLORINE-BASED PRODUCTS(ETHYLENE CHLORIDE), AND OILBASED PRODUCTS (PINE-SOL,LESTOIL). THESE ARE NOT TO BE
USED TO CLEAN THE PLASTIC
HOUSING ON THE FREESTYLECOMFORT, THEY CAN DAMAGE
THE UNIT’S PLASTIC.
Note: Make the bleach solution a 1:100 dilutionof 5.25% sodium hypochlorite. Mix one parthousehold bleach (e.g., Clorox with 99 parts
cold tap water). To measure the solution easily,take ¼ cup of household bleach, and mix it witha gallon of cold tap water. Allow the mixture to
sit on potentially contaminated surfaces for ten
minutes.
Note: CAIRE does not recommend thesterilization of this equipment.

Clean or replace the air intake filter with warm soapy
water between each patient use. The patients should be
instructed to clean this filter at least once per week,
depending on the environment, during normal
operation.
Allow the unit to air dry. Then re-test oxygen
concentration, test the duration of the battery pack, andensure the AC and DC power supplies are in goodworking condition before you return the unit to yourinventory.

25

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FreeStyle Comfort
Recording Maintenance
Whenever maintenance or service is performed on a unit, an entry should be made in the service log for thatconcentrator or recorded in accordance with your company’s standard procedure.

FreeStyle Comfort Serial Number
DATE

26

HOUR
METER
READING

INITIALSSERVICEPERFORMEDSYSTEM CHECKOUT COMMENTS
PURITY

ALARM

MN242 Rev C

FreeStyle Comfort
Service Procedures

5. Flip the unit in the upright position and pull downon the sieve beds to remove from the manifold.

WARNING: TURN OFF THE UNIT,DISCONNECT THE POWER CORD FROMTHE ELECTRICAL OUTLET BEFOREYOU CLEAN THE UNIT TO PREVENT
ACCIDENTAL ELECTRICAL SHOCK AND
BURN HAZARD.
REMOVE THE BATTERY FROM THE UNIT BEFOREPERFORMING ANY MAINTENANCE TO PREVENT
ACCIDENTAL ELECTRICAL SHOCK AND BURN
HAZARD. THE FREESTYLE COMFORT MUST BE
OFF AND DISCONNECTED FROM XTERNAL POWER
BEOFRE REMOVING THE BATTERY PACK.

Sieve Bed Replacement
1. Disconnect the unit from the AC or DC outlet.
2. Remove the battery and flip the unit upside down.
3. Remove the four screws using a T8 torx bit
screwdriver.

6. Perform the steps in reverse to replace the old sieve
beds with new sieve beds.

Feed/Waste Valve Replacement
Feed/Waste valves are designed to last the life of theunit. Signs of Feed/Waste valve failure: Low O2
 High or Low System Pressure

Replacement Instructions
4. Pull the manifold outward and flex the sieve bed out
slightly from the unit so the manifold can clear the
support bolts. Then simply lift the manifold up andoff the sieve bed.

27

1.
2.
3.
4.
5.

Disconnect the unit from the AC or DC outlet.
Remove the battery and flip the unit upside down.
Remove the 4 fasteners using a T8 torx driver.
Remove the bottom case plastic.
Remove zip tie from the manifold to valve pressureconnection.
6. Remove silicone tubing from feed/waste valve.
7. Disconnect valve from the circuit board.
8. Remove feed/waste valves from sieve beds.
9. Cap sieve bed inlet to prevent moisture ingress whilevalve is removed.
10. Connect new valve to the silicone tubing.
11. Replace zip tie from the manifold to valve pressureconnection.
12. Place valve on sieve bed inlet.
13. Connect valve to the circuit board.
14. Reassemble bottom case plastic using the T8
fasteners (QTY 4).

MN242 Rev C

FreeStyle Comfort
Troubleshooting
Before reviewing the Troubleshooting Chart, the following steps may be useful to isolate any malfunctions:
1.

Make sure all filters are clean.

2.

To test the oxygen concentration, the unit must be turned on. With the unit turned on, press the following
sequence of buttons “+ + - - + - + -”. In order for the unit to recognize the following sequence, it must beentered within a 5 second time period. If the sequence of buttons is entered correctly, the unit will alarmand the screen will change, having a red border around the screen, indicating the unit is now in test mode.

3.

After ten minutes of running in test mode, measure the oxygen concentration. The acceptable O2 range is
90% oxygen +5.5/-3%

4.

Make sure the unit is leak-free by testing all tubing connections and fittings with a leak-testing solution.
Protect the circuit board from the solution, and start the leak test at the compressor, following the air flowof the unit to the oxygen outlet. Repair all leaks by tightening connections and fittings.

5.

To exit test mode, turn off the unit. Be sure to exit test mode before returning the unit to patient use.

Note: The Pulse setting can be increased or decreased as normal operation while in test mode.
The alarm code can stack, e.g., 0x0003 indicates both battery high temperature and case high temperature.
(0x0001 and 0x0002)
The table below is for a single alarm instance at a time. Active Alarm codes are combined through a bit-wise AND
function, so that if multiple alarms are present simultaneously, each alarm can be discerned separately. For
example, Alarm Code 0x00C0 would indicate Alarms 0x0040 and 0x0080 simultaneously.

Decimal
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15

28

Hexadecimal
1
2
3
4
5
6
7
8
9
A
B
C
D
E
F

MN242 Rev C

FreeStyle Comfort
Troubleshooting Table
Review the Troubleshooting Chart that follows to isolate and repair a malfunction:
Alarm
Code
(Hex)

Run Mode
Display

Alarm
Description

ProbableCause

0x0000None

NormalOperation

None

0x0001

BatteryHigh
Temperature

Hot Battery

Test unit with abattery at room
temperature.

Defective
Battery

Suggested
ActionTest unit withanother battery.

0x0002

Case High
Temperature

Case
Temperature
GreaterThan 60°C
Vent
Blockage

Unit isreaching
battery safety
shutdown
threshold.
Unit will shut
down ifthreshold isreached.
1 Beep Every
20 secEnsure there
are noblockages onany vents of
the unit.

Unit isreaching
shutdown
threshold.
Unit will shut
down if itreaches aninternal
temperature of
65°C.

Contact Cairefor repair.

High
Pressure

1 Beep Every
20 secAllow unit tocool down.

Other

0x0004More Details

Sieve Bed
FailureReplace sieve
beds.

Feed /Waste
Valve
FailureReplace feed /waste valves.

1 Beep Every
20 secContact Cairefor repair.

Other

29

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FreeStyle Comfort
0x008

No Breath
Detected

Outlet Filter
Other

Ensure thecannula is leakfree.
Replace outlet
filter.
Contact Cairefor repair.

1 Beep Every
30 secNo breathdetected for 15
seconds.
Activated after
first breath orwarm upscreen is off,
whichevercomes sooner.
During No
BreathDetected
alarm, the unit
will auto-dose
at 20 BPM
until a breath isdetected andthe alarm isdisabled.

0x0010Low Battery
Shutdown

Battery
Level
Below 5%

Test unit with achargedbattery.

Defective
Battery

Test unit withanother battery.

1 Beep Every
30 secAlarms until
battery runsout of power
and unit shuts
down.

0x0020O2 Warmup

Unit isWarmingUp

Allow the unit
to warm up for
15 minutes.

Unit will startby auto-dosing
until a breath isdetected orWarm Up
ends,
whichever issooner.

0x0040Low O2Intake Filter
Clogged

Clean orreplace intake
filters.

1 Beep Every
30 sec, for up
to 5 minSieve Bed
FailureLow / High
Pressure

Replace sieve
beds.
See Low / High
Pressure

Other
Contact Cairefor repair.

30

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FreeStyle Comfort
0x0080

OCD
FailureKink inCannulaOutlet /Product
FilterClogged

0x01000x0200Low Battery
WarningBreath Rate
Exceeded

Ensure there
are no kinks inthe cannula.
Replace outlet /product filter.

Other

Contact Cairefor repair.

Battery
Level 10%or Below

Test unit with achargedbattery.

Defective
Battery

Test unit withanother battery.

Patient
BreathingMore Than
40 BPMRun unit innormaloperation for
15 minutes
without
breathing off
the unit. Ensure
alarm does notoccur during
this period.

Other

1 Beep Every
20 sec1 Beep, No
Repeat1 Beep Every
60 secContact Cairefor repair.
0x0400Fan Failure

Other

Contact Cairefor repair.

0x0800Low
Pressure

Intake Filter
Clogged /Pinched

Clean orreplace intake
filters.

CloggedInlet Tubing

Verify thatcompressor
inlet tubing is
not pinched or
clogged.

Feed /Waste
Valve
FailureSieve Bed
FailureOther

Replace feed /waste valves.
Check for leaks
on bottom
sieve bed caps.
Replace sieve
beds.
Contact Cairefor repair.

31

MN242 Rev C

FreeStyle Comfort
0x1000Low
Temperature

Case
Temperature
Less Than
0°C

Allow unit towarm up toroom
temperature.

0x2000Compressor
FailureOther

Contact Cairefor repair.

0x4000O2 Out of
Range

Other

Contact Cairefor repair.

32

MN242 Rev C

FreeStyle Comfort
Accessories and Parts List
For proper performance and safety, use only these listed accessories supplied by CAIRE through youroxygen provider. Use of accessories not listed below could adversely affect the performance and/ or
safety of the concentrator.

FreeStyle Comfort Standard Accessories
Battery, 8-Cell

BT034-1S

Battery 16-Cell

BT035-1S

Carrying Bag

MI396-1

Backpack

MI459-1

Shoulder Strap

MI397-1

Power Supply,120W 15V

PW036-1S

Oxygen Outlet Spanner

21168706

DC Cord

CD041-1

Optional Accessories Available
Desktop Battery Pack
Charger

BT036-1

Spare Parts List

Sieve Beds

BE566-1S

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

33

MN242 Rev C

FreeStyle Comfort
Notes

34

MN242 Rev C

FreeStyle Comfort

CAIRE Inc.
2200 Airport Industrial Dr., Ste 500
Ball Ground, GA 30107
www.caireinc.com

Medical Product Services GmbH
Borngasse 20
35619 Braunfels, Germany
Tel: +49 (0) 6442-962073
E-mail: info@mps-gmbh.eu
www.caireinc.com

The unit is not approved for the U.S. and is for export only.
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 © 2020 CAIRE Inc. reserves the right to discontinue its products, orchange 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.

35

9 July 2020 PN MN242 Rev C