User Manual

FreeStyle™ & FreeStyle™ 5

Contents
User Controls & System Status Indicators..............................................3
What is the Oxygen Concentrator...........................................................4
Why Your Physician Prescribed Oxygen................................................4
Operator Profile.......................................................................................5
Unpacking Your FreeStyle or FreeStyle 5..............................................5
Getting to Know Your FreeStyle or FreeStyle 5.....................................6
Indications for Use..................................................................................8
Contraindications for Use.......................................................................8
Safety Guidelines....................................................................................8
Operating Instructions...........................................................................13
Power Supplies.....................................................................................15
Battery Pack..........................................................................................15
FreeStyle AC & DC Power Supply.......................................................17
FreeStyle 5 AC & DC Power Supply....................................................19
Cleaning, Care & Routine Maintenance...............................................21
Alarm Conditions..................................................................................23
Troubleshooting....................................................................................24
Travel Information................................................................................25
Accessories...........................................................................................25
Carrying Bag Instructions.....................................................................26
Materials in Direct Contact with the Operator......................................27
EMC Testing.........................................................................................27
Notes.....................................................................................................31
2 — MN218 B

User Controls & System Status Indicators
SymbolDefinition

SymbolDefinition

Consult instructions for use

Do not disassemble

No Smoking Icon: Do not smoke near unit.

Use no oil or grease.

This side up

No open or naked flames.

RTCA/DO-160
Section 21 RTCA DO160 Section 21 Category M
Category M Compliant. FAA SFAR 106 requirement
Compliant

Safety agency for CAN/CSA C22.2 No. 60601-108 M90 for medical electrical equipment

Fragile – handle with care

Safety agency for CAN/CSA C22.2 No. 601.1
M90 for medical electrical equipment

Type BF Equipment

FAA Approved – POC

Name and address of manufacturer

Serial Number

Authorized representative in the European
Community

Date of Manufacture

Catalog number

Class II Equipment, Double Insulated

Do not get wet.

Prescription onlyThis device complies with the requirementsof Directive 93/42/EEC concerning medical
devices. It therefore bears the CE marking as
shown.

Indicates the temperature limits to which the
medical device can be safely exposed.

This symbol is to remind the equipment
owners to return it to a recycling facility atthe end of its life, per Waste Electrical andElectronic Equipment (WEEE) Directive.

FreeStyle & FreeStyle 5 User Manual — 3

What is the Oxygen Concentrator
The air we breathe contains approximately 21%
oxygen, 78% nitrogen, and 1% other gasses. In the
FreeStyle and FreeStyle 5, room air is drawn into
the machine through the air intake. 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.
FreeStyle and FreeStyle 5 combine advanced
oxygen concentrator and oxygen conserving
technologies to create a portable device that allows
for maximum portability and ambulation. Theiradvanced pulse flow delivery quickly senses when
the user breathes in and delivers a pulse of oxygenat the beginning of each inhalation. Pulse flow
delivery is ideal for activities and time away fromhome. It conserves oxygen and extends battery
life as opposed to continuous flow. The FreeStyleand FreeStyle 5 are both lightweight enough to be
carried via handle, shoulder strap, or backpack.
They can be operated on AC, DC (vehicle) orbattery power.

Why Your Physician Prescribed Oxygen
Many people suffer from a variety of heart, lung,and other respiratory diseases. A significant
number of these people can benefit fromsupplemental oxygen therapy at home, whentraveling, or while participating in daily activities
away from home.
Oxygen is a gas that makes up 21% of the room air
we breathe. Our bodies depend on a steady supply
to function properly. Your physician prescribeda flow or setting to address your particularrespiratory condition.

4 — MN218 B

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

Operator Profile
Concentrators are intended to supply supplemental
oxygen to users suffering from discomfort due toailments which effect the efficiency of ones lungs
to transfer oxygen in the air to their bloodstream.
Portable oxygen concentrators (POCs) do notstore or contain oxygen. They do not need to berefilled, and can recharge anywhere AC or DC
power is available. This makes the user relatively
self-sufficient in terms of in-home use, ambulation(both within and outside of the home), mobility,
and overall lifestyle. Oxygen concentrator use
requires a physician’s prescription and is notintended for life support use.

Although oxygen therapy can be prescribed forusers of all ages, the typical oxygen therapy user
is older than 65 years of age and suffers from avariety of respiratory diseases, including Chronic
Obstructive Pulmonary Disorder (COPD). Users
typically have good cognitive abilities and must
be able to communicate discomfort. If the user
is unable to communicate discomfort, or unable
to read and understand the concentrator labelingand instructions for use, then use is recommended
only under the supervision of one who can. If any
discomfort is felt while using the concentrator,
users are advised to contact their healthcare
provider. Users are also advised to have back-up
oxygen available (i.e. cylinder oxygen) in the eventof a power outage or concentrator failure. There
are no other unique skills or user abilities requiredfor concentrator use.

Unpacking Your FreeStyle or FreeStyle 5
Verify that all of the components listed andshown below are included in the package. If any
items are missing, contact your oxygen provider
immediately.
FreeStyle:• Portable Oxygen Concentrator• Carrying Bag• Shoulder Strap• Carry-All Accessory Bag• Battery Pack
• AC/DC Universal Power Supply• AC Power Cord
• DC Power Cable• User’s Manual
FreeStyle 5:• Portable Oxygen Concentrator• Carrying Bag• Shoulder Strap• Carry-All Accessory Bag• Battery Pack
• AC Power Supply• DC Power Supply• User’s Manual

FreeStyle & FreeStyle 5 User Manual — 5

Getting to Know Your FreeStyle or
FreeStyle 5
Become familiar with the key features of the FreeStyle and FreeStyle 5 and their control panels

HandleControl Panel

Oxygen Outlet

Air Outlet(s)Inlet for Power
Connections

Battery Pack

Air Intake/Filter
Cover

6 — MN218 B

Battery Pack
Release Button

Alarm Indicator
Light

Battery Gauge
Indicator Lights

Pulse Flow
Indicator

Battery Status
ButtonFlow Selection
Buttons

Flow Selection Buttons:

Battery Status Button:

To power the device ON or OFF, press the numericbutton of your prescribed pulse flow setting. The
Pulse flow indicator light will illuminate green
above the selected flow setting when the unit is
ON. You can also change flow settings by pressing
the numeric button of the desired setting.

Press once to display the battery gauge indicator
to determine how much time is remaining on the
charge of the installed battery pack.

Pulse Flow Indicator Lights:
Will illuminate green to indicate the selected flow
setting. The light above the flow selection button
indicates it is running at that flow setting. The
pulse flow indicator light will blink with each
inhalation to indicate oxygen has been delivered.

Battery Gauge Indicator Lights:
Each light represents approximately 25% of thetotal battery pack charge. Battery charge will
display when the battery status button is pressed.
When the battery is charging, the indicator lights
will blink until the % capacity level is reached.
Once the capacity level is reached they will turnsolid.

Alarm Indicator Light:
Indicates an alarm condition on the concentrator.
A prompt response is necessary. Refer to thetroubleshooting table in this manual, and contact
your homecare provider if necessary for assistance.

FreeStyle & FreeStyle 5 User Manual — 7

Important!

Safety Instructions are defined asfollows:
WARNING: IMPORTANT SAFETYINFORMATION FOR HAZARDS THAT MIGHT
CAUSE SERIOUS INJURY.
CAUTION: Important information forpreventing damage to the FreeStyle or
FreeStyle 5.
Note: Information needing special attention.

Indications for Use
WARNING: IT IS VERY IMPORTANT TO
SELECT ONLY THE PRESCRIBED LEVEL OFOXYGEN. DO NOT CHANGE THE FLOWSELECTION UNLESS YOU HAVE BEEN
DIRECTED TO DO SO BY A LICENSED
CLINICIAN. THE PORTABLE OXYGENCONCENTRATOR MAY BE USED DURINGSLEEP UNDER THE RECOMMENDATION OF
A QUALIFIED CLINICIAN.
WARNING: FEDERAL (USA) LAW RESTRICTS THIS
DEVICE TO SALE OR RENTAL BY ORDER OF APHYSICIAN OR OTHER LICENSED HEALTH CAREPROVIDER.
WARNING: THIS UNIT IS NOT TO BE USED FOR LIFE
SUPPORT. GERIATRIC, PEDIATRIC, OR ANY OTHER
USER UNABLE TO COMMUNICATE DISCOMFORT
WHILE USING THIS DEVICE MAY REQUIRE ADDITIONALMONITORING. USERS WITH HEARING AND/OR SIGHT
IMPAIRMENT(S) MAY NEED ASSISTANCE WITH
MONITORING ALARMS.
WARNING: PULSE DOSE MODE SETTINGS MUST BE
DETERMINED FOR EACH USER INDIVIDUALLY FOR
THEIR NEEDS AT REST, DURING EXERCISE, AND WHEN
TRAVELING.

Contraindications
for UseWARNING: IN CERTAIN CIRCUMSTANCES,
THE USE OF NON-PRESCRIBED OXYGENCAN 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 ELECTRICALLY POWEREDDEVICE, THE USER MAY EXPERIENCE PERIODS OFNON-OPERATION AS A RESULTS OF ELECTRICAL
POWER INTERRUPTION, OR THE NEED TO HAVE THE
OXYGEN CONCENTRATOR SERVICED BY A QUALIFIEDTECHNICIAN. THE OXYGEN CONCENTRATOR IS
NOT APPROPRIATE FOR ANY USER WHO WOULD
EXPERIENCE ADVERSE HEALTH CONSEQUENCES AS
THE RESULT OF SUCH TEMPORARY INTERRUPTION.

Safety Guidelines
WARNING: NO MODIFICATION OF THISEQUIPMENT IS PERMITTEDWARNING: THE MANUFACTURER RECOMMENDS AN
ALTERNATE SOURCE OF SUPPLEMENTAL OXYGEN IN
THE EVENT OF A POWER OUTAGE, ALARM CONDITION,
OR MECHANICAL FAILURE. CONSULT YOUR PHYSICIANOR EQUIPMENT PROVIDER FOR THE TYPE OF RESERVESYSTEM REQUIRED.
WARNING: THIS DEVICE SUPPLIES HIGHCONCENTRATION 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 CAN RESULT IN SEVERE
FIRE, PROPERTY DAMAGE, AND/OR CAUSE PHYSICALINJURY OR DEATH.
WARNING: DO NOT OPERATE UNIT IN A RESTRICTEDOR CONFINED SPACE (I.E., A SMALL CASE OR
HANDBAG) WHERE VENTILATION CAN BE LIMITED.
THIS CAN CAUSE THE OXYGEN CONCENTRATOR TO
OVERHEAT AND IMPAIR PERFORMANCE.
WARNING: THE CONCENTRATOR SHOULD BE LOCATEDAS TO AVOID SMOKE, POLLUTANTS OR FUMES.
WARNING: THE USE OF SOME OXYGENADMINISTRATING ACCESSORIES NOT SPECIFIEDFOR THIS OXYGEN CONCENTRATOR MAY IMPAIR ITSPERFORMANCE. RECOMMENDED ACCESSORIES ARE
REFERENCED WITHIN THIS MANUAL.
WARNING: IF YOU SMOKE, YOU MUST ALWAYS
FOLLOW THESE 3 IMPORTANT STEPS FIRST: TURN
OFF THE OXYGEN CONCENTRATOR, TAKE OFF THE
CANNULA, AND LEAVE THE ROOM WHERE THIS DEVICEIS LOCATED.

8 — MN218 B

WARNING: IF THE OXYGENCONCENTRATOR HAS BEEN
DROPPED, DAMAGED OR EXPOSEDTO WATER PLEASE CONTACTYOUR HOME CARE PROVIDER FOR
INSPECTION OR POSSIBLE REPAIR
OF THE DEVICE. DO NOT USE THE
OXYGEN CONCENTRATOR IF IT HAS ADAMAGED POWER CORD OR PLUG.
WARNING: PROPERLY SECURE, BELT OR
OTHERWISE 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 REMOVALOF THE BATTERY FROM THE DEVICE FOR
ALL INTERNATIONAL AIRLINE TRAVEL WHEN
THE OXYGEN CONCENTRATOR IS CHECKED
AS LUGGAGE. WHEN SHIPPING THE OXYGENCONCENTRATOR, THE BATTERY MUST ALSO BE
REMOVED FROM THE DEVICE AND PACKAGED
PROPERLY.
WARNING: DO NOT OPERATE THISEQUIPMENT WITHOUT FIRST READING AND
UNDERSTANDING THIS MANUAL. IF YOU ARE
UNABLE TO UNDERSTAND THE WARNINGS AND
INSTRUCTIONS, CONTACT YOUR EQUIPMENTPROVIDER BEFORE ATTEMPTING TO USE THISEQUIPMENT; OTHERWISE, INJURY OR DAMAGE
MAY RESULT.
WARNING: IF YOU FEEL DISCOMFORT OR ARE
EXPERIENCING A MEDICAL EMERGENCY, SEEKMEDICAL ASSISTANCE IMMEDIATELY.
WARNING: OPERATING THE OXYGENCONCENTRATOR OUTSIDE OF THE
OPERATIONAL TEMPERATURE SPECIFICATIONSCAN LIMIT THE CONCENTRATOR’S ABILITYTO MEET OXYGEN CONCENTRATIONSPECIFICATION. REFER TO THE SPECIFICATIONSECTION OF THIS MANUAL FOR TEMPERATURE
LIMITS.
WARNING: USE NO OIL, GREASE,OR PETROLEUM-BASED OR OTHER
FLAMMABLE PRODUCTS WITH THE OXYGENCARRYING ACCESSORIES OR THE OXYGENCONCENTRATOR. ONLY WATER BASED, OXYGENCOMPATIBLE LOTIONS OR SALVES SHOULD BE
USED. OXYGEN ACCELERATES THE COMBUSTION
OF FLAMMABLE SUBSTANCES.

WARNING: DO NOT ALLOW EITHER THE AIRINTAKE OR THE AIR OUTLET EXHAUST TO
BECOME BLOCKED. DO NOT DROP OR INSERTANY OBJECTS INTO ANY OPENINGS ON
THE DEVICE. THIS CAN CAUSE THE OXYGENCONCENTRATOR TO OVERHEAT AND IMPAIRPERFORMANCE.
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
GENERATEDWARNING: 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 IMMUNITY OF THE OXYGENCONCENTRATOR.
WARNING: USE ONLY ELECTRICAL VOLTAGE
SPECIFIED ON THE SPECIFICATION LABELAFFIXED TO THE DEVICE.
WARNING: DO NOT USE EXTENSION CORDSWITH 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 ONEOUTLET CAN RESULT IN AN OVERLOAD TO THE
ELECTRICAL PANEL CAUSING THE BREAKER/FUSE TO ACTIVATE OR FIRE IF THE BREAKER ORFUSE FAILS TO OPERATE.
FreeStyle & FreeStyle 5 User Manual — 9

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
THIS MANUAL. DO NOT REMOVE
COVERS, ONLY YOUR EQUIPMENTPROVIDER OR A QUALIFIED SERVICETECHNICIAN SHOULD REMOVE THE
COVERS OR SERVICE THIS DEVICE.
WARNING: ONLY ACCESSORIES RECOMMENDED
BY THE MANUFACTURER.USE OF ANY OTHER
MAY BE HAZARDOUS, CAUSE SERIOUS DAMAGE
TO YOUR OXYGEN CONCENTRATOR AND WILL
VOID THE WARRANTY .
WARNING: THE MANUFACTURER RECOMMENDS
AN ALTERNATE SOURCE OF 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 OXYGENIS 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 SAMEROOM WITH THE DEVICE OR THE OXYGENCARRYING ACCESSORIES.
WARNING: SMOKING WHILE WEARING ANOXYGEN CANNULA MAY CAUSE FACIAL BURNSAND 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.

10 — MN218 B

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,
MEDICAL OXYGEN.
WARNING: DO NOT USE YOUR OXYGENCONCENTRATOR IN THE PRESENCE OF
FLAMMABLE GASES. THIS CAN RESULT IN
RAPID BURNING CAUSING PROPERTY DAMAGE,
BODILY INJURIES OR DEATH.
WARNING: REMOVING THE CANNULA AND
PUTTING IT ON CLOTHING, BEDDING, SOFAS,OR OTHER CUSHION MATERIAL WILL CAUSE A
FLASH FIRE WHEN EXPOSED TO A CIGARETTE,HEAT SOURCE, OR FLAME.
WARNING: DO NOT LEAVE A NASAL CANNULA
ON OR UNDER CLOTHING, BED COVERINGS OR
CHAIR CUSHIONS. IF THE UNIT IS TURNED ON
BUT NOT IN USE, THE OXYGEN WILL MAKE THE
MATERIAL FLAMMABLE. ENSURE THE POWER
IS OFF WHEN THE OXYGEN CONCENTRATOR IS
NOT IN USE.
WARNING: THE FREESTYLE OR FREESTYLE 5
MUST BE OFF AND DISCONNECTED FROMEXTERNAL POWER BEFORE REMOVING THE
BATTERY PACK.

CAUTION: Always disconnect AC power
supply from the wall before disconnection
the AC power supply from the oxygen
concentrator.
CAUTION: Do not position the Concentrator so that itis 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. If the DC power supply does notilluminate and requires resetting, disconnect the DC
power supply from the DC outlet, restart your vehicle,
and then reconnect your DC power supply into the
DC outlet. Failure to follow these instructions canresult in the power supply not supplying power to the
Oxygen Concentrator.
CAUTION: When the automobile in which you areusing the Oxygen Concentrator unit is turnedoff, disconnect and remove the device from theautomobile. Do not store the Oxygen Concentrator ina very hot or cold automobile or in other similar, highor low-temperature environments.

Note: Ensure the cannula is fully inserted and secure.
This ensures that the Oxygen Concentrator can properly
detect inspiration for oxygen delivery. During inhalation,
you should hear or feel oxygen flow to the prongs of thenasal cannula.
Note: Lithium batteries may permanently lose capacity
when exposed to extremely hot temperatures withthe batteries fully charged or completely depleted. For
extended storage, it is recommended that batteries becharged 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 arereferenced 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 the oxygen in aroom when you use your oxygen concentrator unit.

Note: Portable and mobile RF communications equipment
can effect medical electrical equipment.
CAUTION: DO NOT leave the Oxygen
Concentrator or the Power Supply plugged
into the vehicle if the ignition is in the OFF
position. Doing so may drain the vehicle’s
battery.
CAUTION: Operating or storing the Oxygen
Concentrator outside of its normal operating
temperature range can affect performance anddecrease battery run time and/or increase battery
charge time. Refer to the Specifications section in thismanual for storage and operating temperature limits.
CAUTION: For oxygen concentrators equipped withbatteries: Store in a cool and dry location to help
ensure the longevity of your battery. Storing yourOxygen Concentrator for extended periods of time
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 no serviceable parts inside the battery. Keepbatteries away from children.
CAUTION: ONLY USE the Manufacturer’s provided
batteries. For proper battery disposal, contact yourEquipment Provider or your local government agency
for disposal requirements.

WARNING: THE FREESTYLE OR
FREESTYLE 5 SHOULD NOT BEOPERATED OR PLUGGED IN TO
EXTERNAL (AC/DC) POWER WITHOUTA BATTERY INSTALLED. DO NOTATTEMPT TO POWER ON THE UNIT
OR CONNECT IT TO EXTERNALPOWER WHEN THE BATTERY PACK ISREMOVED.
ONLY REMOVE THE BATTERY PACK WHEN THE
UNIT IS POWERED OFF AND UNPLUGGEDFROM THE POWER SUPPLY. DO NOT ATTEMPTTO REMOVE THE BATTERY PACK WHILE THE
UNIT IS STILL ON OR PLUGGED INTO THE
POWER SUPPLY.

Note: If the oxygen concentrator has been stored
for an extended period of time outside of its normal
environmental operating conditions shown in the table
above, it should be allowed to return to normal operating
temperature before being powered on.

FreeStyle & FreeStyle 5 User Manual — 11

Specifications
FreeStyle

FreeStyle 5

8.6 in x 6.1 in x 3.6 in

10.7 in x 6.6 in x 4.4 in(21.8 cm x 15.5 cm x 9.1 cm)(27.2 cm x 16.8 cm x 11.2 cm)

Weight (w/ Battery
Pack)

4.9 lbs (2.2 kg)

6.7 lbs (3.0 kg)

Nominal Sound Level

41 dB(A) at setting 2

48 dB(A) at setting 3

44 dB(A) at setting 3

51 dB(A) at setting 5

Pulse Settings 1, 2, 3

Pulse Setting 1, 2, 3, 4, 5Dimensions

Flow Settings
Oxygen Concentration

90% oxygen +5.5/-3%

90% oxygen +5.5/-3%

AC Power

100-240 VAC, 50-60 Hz (1.75 amps max)

100–240 VAC, 50/60 Hz (2 amps max)

DC Power

11–16 VDC (8.0 amps max)

12-24 VDC (15 amps max)Battery Pack

Rechargeable, lithium battery

Rechargeable, lithium battery

Setting 1 – 6.5 hours

Setting 1 – 4.25 hours

Setting 2 – 3.5 hours

Setting 2 – 2.5 hours

Setting 3 – 3 hours

Setting 3 – 1.75 hours

Battery Pack Durations

Setting 4 – 1.5 hours
Setting 5 – 1.25 hrs
Warm Up Time

2 minutes

2 minutes

Operating Temperature

41°F to 104°F (5°C to 40°C)

41°F to 104°F (5°C to 40°C)

Storage Temp. (Unit)-4°F to 140°F (-20°C to 60°C)-4°F to 140°F (-20°C to 60°C)

Storage Temp. (Battery)

1 month -4°F to +122°F (-20 to +60 C)

1 month -4°F to +122°F (-20 to +60 C)

3 months -4°F to +104°F (-20 to +45C)

3 months -4°F to +104°F (-20 to +45C)

1 year -4°F to +68°F (-20 to 20C)

1 year -4°F to +68°F (-20 to 20C)

Operating Altitude

Up to 12,000 ft (3,657.6 m)

Up to 12,000 ft (3,657.6 m)

Operating Humidity<95%, non-condensing<95%, non-condensing* 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

12 — MN218 B

Operating Instructions
1 Locate and position the FreeStyle or FreeStyle 5
in a proper location for use.
a The concentrator should be well-ventilated sothat they air intake and air outlets are not be
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 filter and filter cover are
in place before operating the unit. If the unit
is missing the filter or filter cover, contact
your equipment provider.

3 Insert the AC or DC power supply into thereceptacle on the right side of the unit if
recharging the battery pack and/or running fromthe external power source.

2 Install a Battery Pack in the concentratora Align the battery with the front housing fromthe right side of the FreeStyle or FreeStyle 5.
4 Connect a nasal cannula to the oxygen outlet
barb. Ensure the connection is secure before
operation.
NOTE: The maximum length or tubing that can be used is
25 ft (7.62 m).

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

FreeStyle & FreeStyle 5 User Manual — 13

5 Turn on the FreeStyle or FreeStyle 5 by pressing
the numeric flow selection button of the pulse
flow setting prescribed by your physician to turnon the device.

A brief audible alarm will sound to indicate thedevice has powered on and the green light above
the flow selection button you pressed should
remain illuminated.
6 Position the nasal cannula on your face per the
manufacturer’s instructions provided with thecannula and breathe normally.
You should feel a puff of oxygen delivered
through the nasal cannula each time you inhale.
The green light above the selected flow rate
button will blink with each dose of oxygen
delivered.
7 To change the flow setting, press the numericbutton of the new desired flow rate. It is normal
to hear a difference in sound as you change theflow settings.
8 Turn the FreeStyle or FreeStyle 5 off by pressing
the button corresponding to the pulse flow
indicator light that is illuminated.

14 — MN218 B

Power Supplies

The FreeStyle and FreeStyle 5 can be powered in
3 ways:• Re-chargeable Battery Pack
• AC Power• DC Power
Information on the operation of each of thesecomponents 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.

REMOVING THE BATTERY:
Pull the battery release button outward away fromthe FreeStyle or FreeStyle 5. While HOLDING
this button, slide the battery out by pulling it awayfrom the concentrator. Use the depressed finger
slot to grip the battery when pulling outward.
WARNING: THE FREESTYLE OR
FREESTYLE 5 MUST BE OFF ANDDISCONNECTED FROM EXTERNALPOWER BEFORE REMOVING THE
BATTERY PACK.

Battery Pack

The FreeStyle or FreeStyle 5 can be operated by
the rechargeable battery pack which is suppliedwith the device. There are no operational
limitations of the concentrator when running fromthe battery pack. All flow rates are available onbattery power.

CHECKING BATTERY PACK CHARGE:
To check the battery charge when it is installed in
the FreeStyle or FreeStyle 5, press the “BATT”
battery status button on the control panel of theconcentrator. The battery gauge indicator lights(25-100%) will illuminate above the BATT button
to indicate the level of the battery pack charge.

INSTALLING THE BATTERY:
Align the battery with the front housing from theright side of the FreeStyle or FreeStyle 5 so that it
will slide into the empty compartment. Push thebattery inward until you hear a click to confirm thatit has locked in place.

Note: If the battery is in the process of charging, the gauge
indicator lights will show the status without pressing the
BATT button.

FreeStyle & FreeStyle 5 User Manual — 15

To check the battery charge when it is not installedin the FreeStyle or FreeStyle 5, turn the battery on
its back 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 ofthe battery pack charge.

INITIAL CHARGING:
The new battery supplied with your FreeStyle or
FreeStyle 5 is only partially charged when it isshipped from the factory. Before using for the
first time, you should fully charge the battery packusing either AC or DC power.

GENERAL CHARGING INFORMATION:
The FreeStyle and FreeStyle 5 will recharge
the battery pack anytime it is installed in theconcentrator and the concentrator is connected toan external AC or DC power source.
While charging a fully discharge battery, the
25% battery gauge indicator light on top of the
FreeStyle or FreeStyle 5 will begin by blinking
rapidly for a few minutes, and then start to blink
at a slower rate (every ½ second). The LED willcontinue to blink until 25% battery capacity isreached. The LED will then turn solid. Each of
the 4 battery gauge indicator lights (25-100%) will
blink as stated above during charging, then turnsolid when they reach capacity.
When all 4 of the battery gauge indicator lights are
solid, the battery is fully charged. The lights willremain on for a short period of time to indicate afull charge, and will then turn off.
Alternately, the battery pack may be charged
using the optional desktop charger. Reference
the manual for the desktop charger (MN221) for
instructions on its operation.
16 — MN218 B

BATTERY OPERATING DURATION:
When external AC or DC power is disconnected,
the concentrator will automatically switch over tousing battery power if the battery pack is installed
and has a charge. The table below shows the
typical durations for a new battery pack.
Battery pack durations will remain constantregardless of your breath rate.
Pulse Setting

FreeStyle

FreeStyle 51

6.5 hours (6 hrs,
30 minutes)

4.25 hrs (4 hrs,
15 minutes)

2

3.5 hours (3 hrs,
30 minutes)

2.5 hrs (2 hrs, 30
minutes)3

3.0 hours (3 hrs)

1.75 hrs (1 hr, 45
minutes)4-

1.5 hrs (1 hr, 30
minutes)5-1.25 hrs (1 hr, 15
minutes)

TYPICAL BATTERY RECHARGE TIME:
The typical time to recharge your battery packinside of the FreeStyle or FreeStyle 5 to achieve
full capacity from a fully discharged battery is
between 4-5 hours.
If using the optional desktop charger, the battery
pack will fully charge in 4-5 hours.

FreeStyle AC & DC Power Supply
The FreeStyle is equipped with a universal AC/DC
power supply to keep your concentrator powered
wherever you go. It replaces separate AC and DC
power supplies so you only have a carry and keep
up with one power supply.
The universal power supply includes the following:
1. Universal power supply (brick) which operates
on:a. AC Power between 100-240 volts, 5060Hz.
b. DC Power sources including 12V
automobile accessory outlets
2. Removable AC power corda. Plug style varies by country or location ofpurchase
3. Removable DC Power Cord

To connect the FreeStyle to AC Power:
1. Connect the universal power supply to thepower connector inlet on the side of the
FreeStyle. Be sure to push inward so that theconnection is secure.

2. Connect the AC power cord to the unmarked
AC inlet on the power supply

AC POWER
AC power is for use at home or wherever standard
AC outlet power is available. The FreeStyle is fully
functional on AC power. The FreeStyle will also
recharge the battery pack if needed any time AC
power is available. The battery pack will recharge
whether the FreeStyle 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
BATTERY PACK INSTALLED IN THE
FREESTYLE OR FREESTYLE 5.

FreeStyle & FreeStyle 5 User Manual — 17

4. Ensure the green light on top of the Universal
power supply is illuminated. This indicatesthat the power supply is receiving power fromthe outlet. If the green light is not illuminated,check for secure connections and refer to thetroubleshooting section of this manual.

2. Connect the DC power cord to the inlet marked“ACCESSORY DC IN” on the universal power
supply3. Connect the opposite end of the DC power
cord to automobile or other DC accessory outlet.
5. If the battery pack is in need of re-charge,
the battery status indicator lights should blink
accordingly to show charging.
6. Turn on the FreeStyle by pressing the numericflow selection button of the pulse flow settingprescribed by your physician to turn on thedevice.

DC POWER
DC power is for use in the accessory outlets ofautomobiles, boat, or other motor vehicles. The
FreeStyle is fully functional on DC power for use.
The FreeStyle will also recharge the battery pack
if needed any time DC power is available. The
battery pack will recharge both if the unit is off oron and in use.

4. Turn on your motor vehicle.
5. Ensure the green light on top of the Universal
power supply is illuminated. This indicatesthat the power supply is receiving power fromthe outlet. If the green light is not illuminated,disconnect the power supply from the DC outlet,
restart the motor vehicle, and then reconnect thepower supply to the DC outlet.

WARNING: DO NOT CONNECT
EXTERNAL POWER WITHOUT A
BATTERY PACK INSTALLED IN THE
FREESTYLE OR FREESTYLE 5.
1. Connect the universal power supply to thepower connector inlet on the side of the
FreeStyle. Be sure to push inward so that theconnection is secure.
6. If the battery pack is in need of re-charge,
the battery status indicator lights should blink
accordingly to show charging.
7. Turn on the FreeStyle by pressing the numericflow selection button of the pulse flow settingprescribed by your physician to turn on thedevice.
18 — MN218 B

FreeStyle 5 AC & DC Power Supply
The FreeStyle 5 is equipped with separate power
supplies for AC and DC operation.

2. Connect the AC power cord to the inlet on the
power supply.

The FreeStyle 5 includes the following:
1. AC power supply which operates on AC Powerbetween 100-240 volts, 50-60Hz.
2. Removable AC power cord
3. DC Power Supply which operates on DC Power
sources including 12V automobile accessory
outlets

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

AC POWER
AC power is for use at home or wherever standard
AC outlet power is available. The FreeStyle
5 is fully functional on AC power for use. The
FreeStyle 5 will also recharge the battery pack
if needed any time AC power is available. The
battery pack will recharge both if the unit is off oron and in use.
WARNING: DO NOT CONNECT
EXTERNAL POWER WITHOUT A
BATTERY PACK INSTALLED IN THE
FREESTYLE OR FREESTYLE 5.
To connect the FreeStyle 5 to AC Power:
1. Connect the AC power supply to the power
connector inlet on the side of the FreeStyle 5.
Be sure to push inward so that the connection issecure.

4. Ensure the green light on top of the AC power
supply is illuminated. This indicates that thepower supply is receiving power from theoutlet. If the green light is not illuminated,check for secure connections and refer to thetroubleshooting section of this manual.

5. If the battery pack is in need of re-charge,
the battery status indicator lights should blink
accordingly to show charging (See Battery Packsection).
6. Turn on the FreeStyle 5 by press the numericflow selection button of the pulse flow settingprescribed by your physician to turn on thedevice.
FreeStyle & FreeStyle 5 User Manual — 19

DC POWER
DC power is for use in the accessory outlets ofautomobiles, boat, or other motor vehicles. The
FreeStyle is fully functional on DC power for use.
The FreeStyle 5 will also recharge the battery pack
if needed any time DC power is available. The
battery pack will recharge both if the unit is off oron and in use.

4. Ensure the green light on top of the DC supply
is illuminated. This indicates that the power
supply is receiving power from the outlet. If
the green light is not illuminated, disconnect
the power supply from the DC outlet, restart the
motor vehicle, and then reconnect the power
supply to the DC outlet.

WARNING: DO NOT CONNECT
EXTERNAL POWER WITHOUT A
BATTERY PACK INSTALLED IN THE
FREESTYLE OR FREESTYLE 5.
1. Connect the DC Power Supply to the power
connector inlet on the side of the FreeStyle. Be
sure to push inward so that the connection issecure.

5. If the battery pack is in need of re-charge,
the battery status indicator lights should blink
accordingly to show charging (See Battery Packsection) .
6. Turn on the FreeStyle 5 by pressing the numericflow selection button of the pulse flow settingprescribed by your physician to turn on thedevice.

2. Connect the DC power cord to automobile orother DC accessory outlet.

3. Turn on your motor vehicle.

20 — MN218 B

Cleaning, Care & Routine Maintenance
ROUTINE MAINTENANCE

2. Remove the filter from the cover.

Servicing of internal components inside of thecabinet of the FreeStyle or FreeStyle 5 must be
performed by the oxygen provider.
The operator is responsible for the following
maintenance procedures.
• Weekly – Clean the Air Intake Filter
WARNING: DO NOT ATTEMPT TO
OPEN OR REMOVE THE PLASTIC
COVERS OF THE FREESTYLE OR
FREESTYLE 5. THE UNIT SHOULD
ONLY BE OPENED BY A QUALIFIEDSERVICE TECHNICIAN.

AIR INTAKE FILTER
Air enters the FreeStyle and FreeStyle 5 throughan air intake filter located under the cover on thelower front of the oxygen concentrator. This filter
prevents dust and other large particles in the airfrom entering the unit.
At least once per week, the Air Intake Filter should
be cleaned. Your oxygen provider may advise
you to clean it more frequently, depending on
the operating conditions. Follow these steps toproperly clean the Air Intake Filter
1. Remove the filter cover from the front of the
FreeStyle or FreeStyle 5 by pulling it outward.

3. Wash the filter in a warm solution of soap andwater
4. Rinse the filter thoroughly and remove excesswater with a soft, absorbent towel. Ensure thefilter is completely dry before replacing it.
5. Replace the clean and dry filter in the filter
cover and re-install the filter cover in the
FreeStyle or FreeStyle 5.
WARNING: DO NOT OPERATE THE
FREESTYLE OR FREESTYLE 5 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 visually,
contact your oxygen provide before use

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 place the battery in or near a microwave orother cooking appliances. Do not leave the battery
in a location exposed to excessive heat, such as indirect sunlight or in a car. Doing so could cause
the battery’s performance and life to deteriorate. It
FreeStyle & FreeStyle 5 User Manual — 21

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 ofcorrosive 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. For 1 year of storage,
it is recommended the battery remains withina temperature range of -4°F to +68°F (-20°C
to +20°C). Every 6 months charge the battery
between 50% and 75% (two to three LEDs) andremove it from the Oxygen Concentrator. For
3 months of storage, it is recommended that thebattery remains within a temperature range of-4°F to +104°F (-20°C to +40°C). For 1 month ofstorage, it is recommended that the battery remains
within a temperature range of -4°F to +122°F(-20°C to +50°C).

BATTERY DISPOSALYour battery is rechargeable and can be recycled.
Always return to your homecare provider for
proper disposal. You can also contact your local
city or town offices for instructions on proper
disposal of the battery.
CAUTION: For proper disposal, contact
your equipment provider or local
government agency for disposal
instructions

CLEANING
Turn OFF the unit and disconnect from AC or DC
power before any cleaning or disinfection activity.
DO NOT spray the outer case directly. Use adamp (not wet) cloth or sponge. Spray the cloth orsponge with a mild detergent solution to clean thecabinet and power supplies. Proceed as directed by
the cleaner manufacturer.
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.
ONLY YOUR EQUIPMENT PROVIDER OR AQUALIFIED SERVICE TECHNICIAN SHOULDREMOVE THE COVERS OR SERVICE THE
UNIT.
WARNING: CARE SHOULD BE TAKEN TO PREVENTTHE OXYGEN CONCENTRATOR AND THE BATTERYPACK FROM GETTING WET OR ALLOWING FLUIDS TOENTER THE UNIT. THIS CAN CAUSE A MALFUNCTION
OR SHUT DOWN, AND CAUSE AN INCREASED RISK FOR
ELECTRICAL SHOCK OR BURNS.
WARNING: DO NOT USE LIQUID DIRECTLY ON
THE UNIT. A LIST OF UNDESIRABLE CHEMICALAGENTS INCLUDES BUT IS NOT LIMITED TO THE
FOLLOWING: ALCOHOL AND ALCOHOL-BASEDPRODUCTS, CONCENTRATOR CHLORINE-BASEDPRODUCTS (ETHYLENE CHLORIDE), AND OIL-BASEDPRODUCTS (PINE-SOL, LESTOIL). THESE ARE NOT TO
BE USED TO CLEAN THE PLASTIC HOUSING ON THE
CONCENTRATOR, AS THEY CAN DAMAGE THE UNIT.
WARNING: CLEAN THE CABINET, CONTROL PANEL,
AND POWER CORD ONLY WITH A MILD HOUSEHOLDCLEANER 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 THEOXYGEN OUTLET FOR THE CANNULA CONNECTION TO
MAKE SURE IT REMAINS FREE OF DUST, WATER, AND
PARTICLESWARNING: USE A DAMP (NOT WET) CLOTH ORSPONGE TO CLEAN THE BATTERY PACK. FIRST SPRAY
THE CLOTH OR SPONGE WITH A MILD HOUSEHOLDCLEANER AND CLEAN THE BATTERY PACK HOUSING.

CANNULA REPLACEMENT
Always follow the cannula manufacturer’s
instructions for proper use. Replace the nasal
cannula or oxygen tubing as recommended by thecannula manufacturer or your oxygen provider.
Your physician or oxygen provider will provide
you with cleaning and replacement instructions.
Additional supplies for replacement are available
through your oxygen provider.

22 — MN218 B

Alarm Conditions
face, and ensure that you are breathing throughyour nose. If the alarm continues to sound, change
to another source of oxygen as available, andcontact your Equipment Provider.

START-UP ALARM
A brief alarm sounds when the FreeStyle or
FreeStyle 5 is first powered on. This is normal.
The concentrator begins to operate once the brief
alarm stops.

BREATH RATE EXCEEDEDAs the battery pack power approaches a low level,a brief alarm sounds intermittently and the yellow
25% battery gauge indicator light will illuminate
intermittently. When this occurs, connect the
FreeStyle or FreeStyle 5 to an AC or DC power
outlet, or change to an alternate oxygen source.
When connected to AC or DC power, theconcentrator will operate while recharging thebattery pack.

If your breathing rate causes the capacity of
FreeStyle or FreeStyle 5 to be exceeded, a rapid
alarm sounds every ½ second, and the alarm lightilluminates red intermittently. When this occurs,
the concentration of oxygen that the FreeStyle
or FreeStyle 5 is supplying is outside of the unit
specifications. You should reduce any physicalactivity, reset alarm by turning unit off and backon, and then if necessary change to anothersource of oxygen as available, and contact yourEquipment Provider.

CANNULA DISCONNECT

GENERAL MALFUNCTION

When FreeStyle or FreeStyle 5 is operating but
does not sense breathing, a constant alarm sounds,
and the alarm light illuminates after 15 minutes. If
this occurs, check the connection from the cannula
to the FreeStyle or FreeStyle 5 unit, make sure thatthe nasal cannula is positioned properly on yourIf FreeStyle or FreeStyle 5 has a generalmalfunction, a rapid alarm sounds every ½ second,
and the alarm light illuminates red continuously.
When this occurs, the concentration of oxygen that
FreeStyle is supplying is below unit specifications.
You should change to another source of oxygen as
available, and contact your Equipment Provider.

LOW BATTERY ALARM

StatusAudible Alarm

Light

Indicates

ActionStart-Up

Brief, continuous at(Green) pulse;
continuous light

FreeStyle or FreeStyle
5 has been turned on

You may begin to operate your FreeStyle
unit.

start–up

NormalOperation

No(Green) pulse;intermittent light

FreeStyle or FreeStyle
5 is delivering oxygen
as a pulse flow.

Continue using FreeStyle normally.

Alarm

Continuous: Beep

(Red) alarm;
continuous light

No breath detectedby the unit for apredetermined time
period.

Check the cannula connection. Ensurethat you are breathing through yournose. If the alarm persists, contact yourEquipment provider.

Alarm

Intermittent: Beep,
beep, beep.

25% (Yellow) BATT;
battery indicator.

Battery voltage is
too low to operate
FreeStyle.

Connect the FreeStyle or FreeStyle 5unit into a DC outlet or an AC outlet
immediately.

Alarm

Rapid intermittent:
Beep, beep, beep.

(Red) alarm;intermittent light

Breathing rate isexceeding the capacityof the FreeStyle or
FreeStyle 5 unit.

Reduce activity, then if necessary use
another source of oxygen as available.
Contact your Equipment Provider.

Alarm

Rapid intermittent:
Beep, beep, beep.

(Red) alarm;
continuous light

General malfunctionof the FreeStyle or
FreeStyle 5 unit has
occurred.

Turn off the unit. Change to anothersource of oxygen, and contact yourprovider.

FreeStyle & FreeStyle 5 User Manual — 23

Troubleshooting
Problem

Probable Cause

Solution

FreeStyle does not operate whena pulse flow selection button ispressed.

Battery is discharged.

Power the unit through the DC outlet, or an AC
outlet.

A continuous alarm sounds
and the (yellow) alarm lightilluminates continuously.

FreeStyle has not detected abreath for 15 minutes.

Malfunction.

Contact your Equipment Provider, and change toanother source of oxygen as necessary.
Check the cannula connection.
Ensure that cannula tubing is not kinked.
Make sure that the cannula is positioned properly
and that you are breathing through your nose. For
mouth-breathing your clinician may recommend achin strap.

Intermittent alarm condition,and the (yellow) BATT lightilluminates intermittently.

Battery requires charging.

Connect to a DC or an AC outlet within 2 minutes, or
exchange battery packs for a fully charged pack.

Rapid alarm condition, and the(yellow) BATT light illuminatesintermittently and FreeStyle
shuts down.

Battery pack charge is too low to
operate the FreeStyle unit.

Connect to DC or an AC outlet immediately.

Intermittent alarm condition,and the (red) alarm lightilluminates intermittently.

Breathing rate has exceeded thecapacity of the FreeStyle unit

Reduce activity, and then turn unit off and back onagain to reset unit. If necessary, change to anothersource of oxygen as available and contact yourEquipment Provider.

Intermittent alarm condition,and the (red) alarm lightilluminates continuously.

A general malfunction has
occurred.

Change to another source of oxygen as available, andcontact your Equipment Provider.

Unit does not start on battery
pack power.

Unit may be hot or cold ifleft outdoors such as in an
automobile.

Allow the unit to reach normal operating
temperature, which may take several minutes if
exposed to temperature extremes.

Delay in recharging internal
battery.

Internal battery exceeds charging
temperature.

Unit may be operated; however, charging may notresume until battery temperature is reduced.

Unit alarms while in automobileand connected to the DC outlet.

No power to the unit if battery
depleted and DC outlet not
charging.

Disconnect the power supply from the automobile
outlet, restart the automobile, and then reconnect
the power supply into the automobile DC outlet toreset the breaker within DC power supply.

All other problems.

24 — MN218 B

Change to another source of oxygen as available, andcontact your Equipment Provider.

Travel Information
The FreeStyle and FreeStyle 5 are both FAA
approved 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 travellingwith a FreeStyle or FreeStyle 5.
It is suggested to always carry extra batteries withyou on trips.
For airline travel, please allow enough battery lifeto account for ground time (preflight check in,security, etc.) and layovers. Most airlines requirethat 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 arecarried on in a secure carrying bag or the carry-all accessory
bag provided.

FAA REGULATION
Spare batteries must be individually protected
to prevent short circuits by placement in theoriginal retail packaging or by otherwise insulation
terminals, 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.

Accessories
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.
FreeStyle Standard Accessories (Included With Package):
Carry-all Accessory Bag

MI320-1

Carrying Case

MI419-1

Shoulder Strap

MI426-1

Universal AC Power Supply(All Cords And Components
Included)

PW032-1 (US Cord)
PW032-2 (EU Cord)
PW032-3 (UK Cord)

Battery Pack

BT033-1

Air Intake Filter

FI144-1

FreeStyle 5 Standard Accessories (Included With Package):
Carry-all Accessory Bag

MI372-1

Carrying Case

MI420-1

Shoulder Strap

MI426-1

AC Power Supply (Cord
Included)

PW035-1 (US Cord)
PW035-2 (EU Cord)
PW035-4 (UK Cord)

DC Power Supply

PW034-1

Battery Pack

BT033-1

Air Intake Filter

FI194-1

Optional Accessories Available
Desktop Battery Pack
Charger

BT032-1 (US Cord)
BT032-2 (EU Cord)
BT032-4 (UK Cord)

Note: Additional options may be available for countryspecific power cords where noted above. Contact CAIRE
or your oxygen provider if alternate options are needed fororder.

FreeStyle & FreeStyle 5 User Manual — 25

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

SHOULDER STRAP INSTALLATION
1. Unclip the carry handle.

INSERTING UNIT INTO CARRYING
BAG
1. Insert unit into bottom of bag, properly aligningfilters and battery openings.

2. Insert long section into same clip.

2. Secure zipper around bottom of pouch.

3. Attach remaining end to other side of carryhandle.

26 — MN218 B

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 and FreeStyle 5 are intended for use in the electromagnetic environment specified below. The
customer or the user of the FreeStyle and FreeStyle should assure that it is used in such an environment.
Emissions Test
RF emissions
CISPR 11
RF emissions
CISPR 11
Harmonic emissions
IEC 61000-3-2
Voltage fluctuations/
flicker emissions
IEC 61000-3-3ComplianceElectromagnetic Environment - GuidanceGroup 1The FreeStyle and FreeStyle 5 uses RF energy only for its internalfunction. Therefore, its RF emissions are very low and are not
likely to cause any interference in nearby electronic equipment.

Class BClass A
Complies

The FreeStyle and FreeStyle 5 are suitable for use in all
establishments, including domestic establishments and those
directly connected to the public low-voltage power supply
network that supplies buildings used for domestic purposes.

FreeStyle & FreeStyle 5 User Manual — 27

Guidance and Manufacturer’s Declaration—Electromagnetic Immunity
The FreeStyle and FreeStyle 5 are intended for use in the electromagnetic environment specified below. The
customer or the user of the FreeStyle and FreeStyle 5 should assure that it is used in such an environment.
Immunity test IEC 60601 test level
Compliance level
Electromagnetic environment –guidance
Electromagnetic
Floors should be wood, concrete orenvironment –±6 kV contact±6 kV contact
ceramic tile. If floors are covered withguidancesynthetic material, the relative humidity±8 kV air
±8 kV airshould be at least 30 %.
IEC 61000-4-2±2 kV for power supply±2 kV for power supply
lines
Electrical fast
Mains power quality should be thatlines
transient/burstof a typical commercial or hospitalenvironment.
IEC 61000-4-4±1 kV for input/output
N/A
lines
±1 kV line(s) to line(s) ±1 kV line(s) to line(s) Mains power quality should be thatSurgeof a typical commercial or hospital
IEC 61000-4-5
environment.
±2 kV line(s) to earth<5 % UT

Voltage
dips, shortinterruptionsand voltage
variations on
power supply
input lines IEC
61000-4-11<5 % UT(>95 % dip in UT )(>95 % dip in UT )for 0,5 cycle

for 0,5 cycle

40 % UT

40 % UT(60 % dip in UT )(60 % dip in UT )for 5 cycles

for 5 cycles

70 % UT

70 % UT(30 % dip in UT )(30 % dip in UT )for 25 cycles

for 25 cycles<5 % UT<5 % UT(>95 % dip in UT )(>95 % dip in UT )for 5 sec

for 5 sec

Power frequency(50/60 Hz)
3A/m
magnetic field
IEC 61000-4-8

3A/m

NOTE UT is the A.C. mains voltage prior to application of the test level.

28 — MN218 B

Mains power quality should be thatof a typical commercial or hospitalenvironment. If the user of the FreeStyleand FreeStyle 5 require continued
operation during power mains
interruptions, it is recommended that
the FreeStyle and FreeStyle are poweredfrom an uninterruptible power supply
or a battery.

Power frequency magnetic fields should
be at levels characteristic of a typicallocation in a typical commercial or
hospital environment.

Guidance and Manufacturer’s Declaration–Electromagnetic Immunity
The FreeStyle and FreeStyle 5 are intended for use in the electromagnetic environment specified below. The
customer or the user of the FreeStyle and FreeStyle should assure that it is used in such an environment.
Immunity test IEC 60601 test level
Compliance level
Electromagnetic environment –guidance
3 VrmsPortable and mobile RF
3 VrmsConducted RF
communications equipment should
150 kHz to 80 MHz
IEC 61000-4-6
be used no closer to any part of the
FreeStyle and FreeStyle 5, including
cables, than the recommended
separation distance calculated from the
3 V/m
3 V/m
Radiated RF
equation applicable to the frequency of
80 MHz to 2,5 GHz
IEC 61000-4-3
the transmitter.
Recommended separation distanced  1.2 P
d  1.2 P = 80 MHz to 800 MHz
d  1.2 P = 800 MHz to 2,5 GHz
where P is the maximum output
power rating of the transmitterin watts (W) according to thetransmitter manufacturer and d is therecommended separation distance inmetres (m).
Field strengths from fixed RF
transmitters, as determined by anelectromagnetic site survey,a should beless than the compliance level in eachfrequency range. b
Interference may occur in the vicinity ofequipment marked with the following
symbol:NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption
and reflection 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 theoreticallywith accuracy. 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 and FreeStyle
5 are used exceeds the applicable RF compliance level above, the FreeStyle and FreeStyle 5 should be observed
to verify normal operation. If abnormal performance is observed, additional measures may be necessary, suchas re-orienting or relocating the FreeStyle and FreeStyle 5.
bOver the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

FreeStyle & FreeStyle 5 User Manual — 29

Recommended separation distances between portable and mobile RFcommunications equipment and the FreeStyle or FreeStyle 5
The FreeStyle and FreeStyle 5 are intended for use in an electromagnetic environment in which radiatedRF disturbances are controlled. The customer or the user of the FreeStyle and FreeStyle 5 can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile RFcommunications equipment (transmitters) and the FreeStyle and FreeStyle 5 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 inmetres (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the
maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption
and reflection 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 General Requirements forsafety.
• CAN/CSA C22.2 No. 60601-1-08 M90
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 EN60601-1-2(EMC).
30 — MN218 B• 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
Method of cleaning and infection control allowed:
Please refer to “Cleaning, Care, and Proper
Maintenance” section of this FreeStyle User
Manual.
Degree of safety of application in the presence offlammable anesthetic gases:
Equipment not suited for such application.
Mode of operation:
Continuous duty.

NotesFreeStyle & FreeStyle 5 User Manual — 31

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

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

Copyright © 2016 Chart Industries. CAIRE Inc. reserves the right to discontinue
its products, or change the prices, materials, equipment, quality, descriptions,specifications and/or processes to its products at any time without prior notice
and with no further obligation or consequence. All rights not expressly statedherein are reserved by us, as applicable.

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MN218 B