AirSep FreeStyle User manual

Patient Manual
FreeStyle™ Portable
Oxygen Concentrator

English: A multilingual version of the manual is available through your equipment provider
.
Español : Una versión multilingüe del manual está disponible a través de su proveedor de equipo.
Français: Une version multilingue du manuel est disponible par l'intermédiaire de votre fournisseur de matériel.
Deutsche
:
Eine mehrsprachige Version des Handbuchs ist in Ihrer Geräte - Anbieter.

TABLE OF CONTENTS
AirSep® FreeStyle™ Portable
Oxygen Concentrator
AirSep’s FreeStyle™ Portable
Oxygen Concentrator 1
Symbols 1
Why Your Physician Prescribed Oxygen 3
What is the FreeStyle Portable
Oxygen Concentrator? 4
FreeStyle for Airline Travel – FAA - App roved 4
Important Safety Rules 5
Getting Started with Y our
FreeStyle Portable Oxygen Concentrator 7
Battery Charging 9
N asal Cannula 11
FreeStyle Unit Components 12
Operating Instructions 13
Power Supplies 14
Filter
s 15
Setting of the Flow Selector 16

TABLE OF CONTENTS
AirSep® FreeStyle™ Portable
Oxygen Concentrator
Alarm/Light Indicators 17
How to Respond to FreeStyle’s Alarm/Light
Indicators 19
Cleaning, Ca
re, and Proper Maintenance 21
Cabinet
21
Filter
22
Carrying Bag
23
Alarm/Servi ce Indicator
23
FreeStyle Accessories 24
Reserve Oxygen Supply 24
Troubleshooting 25
FreeStyle Specifications 27
Classification 28
Limited Warranty 29

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1
AirSep’s
FreeStyle™ Portable Oxygen Concentrator
This Pati ent Manual will acquaint you with AirSep’s FreeStyle™ Portable Oxygen Concentrator (POC). Make sure you read and
understand all the information contained in this manual before you operate your FreeStyle unit. Should you have any questions, your
Equipment P rovider will be happy to answer them for you .
Symbols
Symbols are frequently used on equipment and/or the manual in preference to words with the intention of decreasing the
possibility of misunderstanding caused by language differences. Symbols can also permit easier comprehension of a concept
within a restricted space.
The following table is a list of symbols and definitions used with the FreeStyle Portable Oxygen Concentrator.
Symbol Description Symbol Description
Warning –
Desc ribes a hazard or
unsafe practice that can result in severe
bodily injury or death
Class II
Caution –
Describes a hazard or
unsafe practice that can result in minor
bodily injury or property damage
CE Mark
Note – Provides information
important enough to emphasize or
repeat
Safety agency for CAN/CSA C22.2 No.
601.1 M90 for medical electrical
equipment
Refer to Patient Manual Instructions Keep unit and accessories dry
No o il or grease
Proper disposal of waste of electrical
and electronic equipment required
No Smoking Do not disassemble

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Type BF Equipment Consult instructi ons for use
RTCA/DO - 160D Section 21
Category M Compliant
FAA SFAR 106 requirement
In the event of an alarm , you observe the FreeStyle is not working properly, or if you feel discomfort, consult your
Equipment Provider and/or your physici an immediately.
This unit is not to be used for life support. Geriatric, pediatric, or any other patients unable to communicate discomfort
while using this machine may require additional monitoring. Patients with hearing and/or sight impairment(s) m ay
need assistance with monitoring alarms.
This device supplies high -c oncentration oxy gen that promotes rapid burning. Do not allow smoking or open flames
within five feet (1.5 m) of (1) this device, or (2) any oxygen - carrying accessory.
Use no oil, grease, or petroleum - based products on or near FreeStyle.
Disconnect the power cord from the electrical outlet before you clean or service the unit.
While using the FreeStyle outdoor s with the AC power supply, connect the power supply into a Ground Fault
Interrupted (GFI) outlet only .
4
Care should be taken to prevent the unit from getting wet or allowing water to enter the unit.

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Why Your Physician Prescribed Oxygen
Many people suffer from a variety of heart, lung, and other respi ratory diseases. A significant number of these patients can benefit
from supplemental oxygen therapy at home, when traveling, or while participating in daily activities away from home.
Oxygen is a gas that makes up 21% of the room air we breathe. Our
bodies depend on a steady supply to function properly. Your
physician prescribed a flow or setting to address your particular respiratory condition.
Although Oxygen i s a non - additive drug, unauthorized oxygen therapy can be dangerous. You must seek medi cal advice before you
use this oxygen concentrator. The Equipment Provider who supplies your oxygen equipment will demonstrate how to set the
prescribed flow rate.
It is very important to select the prescribed level of oxygen flow. Do not increase o r decrease the flow until you fi r st
consult your physician.
Th e FreeStyle Portable Oxygen Concentrator may be used during sleep under the recommendation of a qualified
clinician.

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What i s the FreeStyle Portable Oxygen Concentrator?
Oxygen concentr ators were introduced in the mid-1970’s and have become the most convenient, reliable source of supplemental
oxygen available today. Oxygen concentrators are the most cost - effective, efficient, and safe st alternative to using high - pressure
oxygen cylinder s or l iquid oxygen. An oxygen concentrator provides all the oxygen you need with no cylinder or bottle deliveries
required.
The air we breathe contains approximately 21% oxygen, 78% nitrogen, and 1% other gases. In the FreeStyle unit, room air passes
thr ough a regenerative, adsorbent material called “molecular sieve.” This material separates the oxygen from the nitrogen . The result is
a flow of high - concentration oxygen delivered to the patient.
FreeStyle combines advanced oxyg en concentrator technology along with oxygen conserving technology for the world’s smallest and
lightest portable ox ygen concentrator at just 4.4 lb (2 kg). The FreeStyle efficiently produces its own oxygen, and quickly delivers it as
a pulse of oxygen when you breathe at the very beginning of your inhalation. This eliminates the waste associated with a continuous
flow oxygen device that flows oxygen while you are exhaling. This pulsing of the oxygen is equivalent to continuous flow. FreeStyle
produces the equivalent of up to 3 LPM (liters per minute) in a lightweight package that can be easily carried and used away from the
home.
FreeStyle ope r ates from four different power sources. (Refer to the Power Supplies section of this manual.)
FreeStyle for Airline Travel
–
FAA - Appro ved
FreeStyle has received the US Federal Aviation Administration’s (FAA) acceptance for onboard in-flight use by oxygen
passengers on commercial airlines via a 2006 amendment to SFAR 106.
In addition, as of May 13, 2009, a new Department of Transporation (DOT)/FAA ruling has determined that US-based carriers,
as well as international flight
s with origination or destination in the US, must allow passengers with FAA-approved portable
oxygen concentrators to use them on board, and in flight, as medically necessary. Check directly with the individual airlines
with which you would like to travel for up
- to- date information on their specific POC policies.

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Important Safety Rules
Carefully review and familiarize yourself with the following important safety information about the portable FreeStyle Oxygen
Concentrator.
In the event of an alarm , y ou observe the FreeStyle is not working properly, or if you feel discomfort, consult your
Equipment Provider and/or your physician immediately.
This unit i s not to be used for life support. Geriatric, pediatric, or any other patients unable to communicate discomfort
while using this machine may require additional monitoring. Patients with hearing and/or sight impairment(s) may need
assistance with monitoring alarms.
Never use FreeStyle with the device itself located in the trunk of an automobile.
Do not allow either the air intake or the air outlets to become blocked. This may affect the performance of the FreeStyle
during use, such as under an automobile or airline seat, or in a carrying bag or case that is not supplied through AirSep.

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When the automobile in which you are using the FreeStyle unit is turned off, disconnect and remove the unit from the
automobile with you. Never allow FreeStyle to be stored in a very hot automobile or in other similar, high - or low -
temperature environments. (Refer to the Specifications section in this manual.)
If the unit has been stored for an extended period of time in a cold environment (outsid e its normal operating range),
the unit should be allowed to warm up to ambient temperature before being turned on.
Federal (USA) law restricts this device to sale by order of a physician.
When using FreeStyle in an automobile, boat, or other v ehicle with the DC power supply, make sure that the vehicle is
started and running befor e connecting the FreeStyle unit. If the DC power supply does not illuminate and requires
resetting , disconnect the DC power supply from the DC outlet, restart your vehi cle, and then reconnect your DC power
supply into the DC outlet.
Although FreeStyle is a low - voltage device, do not remove its housing. Only your Equipment Provider should remove
the unit covers.
While using FreeStyle outside of its normal opera ting temperature range, there may be a decrease in battery
performance or an increase in charge time.

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7
Getting Started with Your FreeStyle Portable Oxygen Concentrator
The FreeStyle packaging contains the following items, as shown in Figures 1-3. If any are missing, contact your Equipment
Provider.
•
FreeStyle Portable Oxygen Concentrator with carrying case.
•Patient manual (not shown)
•
AC power supply (100 -240 volts, 50/60 Hz) with power cord.
•
Automobile DC power supply
Figure 2: FreeSytle AC Power Supply/Power Cord
Figure 1: FreeStyle Unit
Figure 3: FreeStyle DC Power Supply

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Optionally, you may also have an AirBelt for extended battery duration. That packaging contains the following, as shown in
Figure 4:
•
AirBelt battery belt
•
AC power supply (100 -240 Volt, 50/60 Hz) with power cord
The incorrect use of the FreeStyle AirBelt can cause the battery t o get hot, ignite, and may cause serious injury. Be
sure not to pierce, strike, step on, or drop the battery, or otherwise subject the battery to strong impacts or shocks.
Never allow FreeStyle or its AirBelt to be stored in a very hot automobile or in other similar, high - or low - temperature
environments. (Refer to the Specifications section in this manual.)
Other optional accessories include a harness to easily convert the FreeStyle carrying bag to a backpack (part number MI284-1),
as shown in Figure 5. The FreeStyle can also be worn on the waist if desired by feeding the AirBelt or other belt you are
wearing throught the loops on the FreeStyle carrying case. (See Figure 6.) The optional accessories bag (part number
MI286 -1)
enables even more convenient travel when transporting all power accessories and optional AirBelts and/or the harness for use at
your intended destination.
Figure 4: AirBelt and AC Power Supply/Power Cord Figure 5: FreeStyle unit worn backpack style Figure 6: FreeStyle unit worn on the waist
Before operating FreeStyle for the first time, famil i arize yourself with the major components. These are illustrated in the figures
on the following pages and discussed later in the manual.

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Battery Charging
Check to make sure your unit’s battery is fully charged before venturing out with FreeStyle for the first time or upon subsequent
use. To check the level of charge of the internal battery, press the BATT button on FreeStyle’s keypad. The battery
gauge/indi cator(s) LEDs above the BATT button illuminate to indicate the level of internal battery charge (25-100%). Note: The
internal battery is charging whenever the unit is operating on AC or DC power. To charge FreeStyle’s internal battery, simply
connect its
A C power supply or DC power supply into the unit’s power connection inlet (as shown in Figure 7). Be certain to
first p r operly align the power cord to this inlet. To do this, take note of the “D” -shaped plug of both the power cord connector
and the FreeSty
le ’s inlet connection. These must be properly aligned and when removing the power cord, the release button
must be pressed to remove it fro m the FreeStyle unit. This ensures that neither the unit nor the power accessories are damaged.
Optional
AirBelt
The optional AirBelt, which can increase FreeStyle’s total battery duration up to 10 hours, requires approximately 3 hours to
completely charge when the external battery is fully depleted. To recharge AirBelt, connect its own AC power supply to the end
of Air Belt’s power cord (as shown in F igure 8 ), and the other end of the power supply into a proper AC power outlet. A separate
battery gauge/indicator for checking the level of charge on the AirBelt’s battery is located on this accessory’s cord and functions
exactly like the internal battery’s indicator on the keypad.
Figure 7: Internal Battery Charging Figure 8: AirBelt Battery Charging
•The FreeStyle’s internal battery will completely recharge from its fully depleted state in approximately 3 ½ hours, whether or not the
unit is in use on AC or DC power .
•While charging a fully discharged battery, initially the 25% LED will start blinking rapidly for a few minutes, then start to blink at a
slower rate every (1/2 seco nd).
•
The LED will continue to blink until 25% capacity is reached. The LED will then turn solid.
•
Each of the four LED s, 25% - 100% , will blink as stated above, then turn solid when they reach their capacity.
•
When all LEDs illuminate solid , the battery is fully charged and the LEDs will remain solid for a period of time, then all four LEDs will
turn off.
FreeStyle unit’s
Power Inlet
Press to remove
power cord.

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10
Charging may take several minutes after connecting the powe r to initiate, depending on the battery’s internal operating
temperature. This is a no
rmal condition and is intended for safe battery charging. This circumstance is more likely when
the battery has been fully discharged.
The rechargeable battery that is used in the FreeStyle unit does not need to be fully depleted before recharging. It is
recommended to charge the battery after each use.
When connected to AC or DC power, the unit’s battery charges until it reaches full capacity, either while the unit is
operating or turned off.
If the power supply remains connected when the in ternal battery is fully charged, the four LEDs will turn off after
approximately one hour.
If the internal battery fully depletes and the FreeStyle unit shuts down, the unit cannot be restarted with the AirBelt.
Should this occur, connect your FreeSty le to its AC or DC power supply for a short period of time in order to provide
sufficient internal battery power to start the unit. AirBelt can then be connected to provide additional run time.
Storing your AirBelt for extended periods of time at hig h temperatures or with a fully charged/completely discharged
battery can degrade its overall battery life.

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Nasal Cannula
A nasal cannula and tubing are used to deliver oxygen from the FreeStyle unit to the user. The tubing is connected to the unit’s
oxygen outlet (See Figure 9 ).
Figure
9 : Connecting Cannula to FreeStyle’s Oxygen Outlet
AirS ep recommends a nasal cannula with 7 ft (2.1 m) of tubing, AirSep Part No. CU002-1. Other lengths of tubing up to 25 ft
(7.6 m) maximum, including nasal cannula, may be used.

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FreeStyle Unit Components
Figure 11: Close-Up of Keypad/Alarm Display
Figure 10: FreeStyle Exterior View - Front
Figure 12: FreeStyle Exterior View - Back
Now that you are familiar with FreeStyle’s components, review the instructions on the following pages to operate the FreeStyle
unit.
Dust Cover
Alarm/Service
Indicator
Pulse Flow
Indicator(s)
Battery Gauge/
Indicator(s)
Flow Selection B utton
(Internal) Battery
Button
Oxygen Outlet
Handle
Air Outlet
Air Outlet
Inlet for Power Connections
Air Intake/Filter
Cover
Label/Patient
Instructions
RTCA DO160D
indicates that
FreeStyle unit has
been tested and
approved to
comply with FAA
standards.

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Operating Instructions
1.
Locate and position the FreeStyle so that the air inlets and air outlets are not obstructed.
2.
Power the unit from (a) the internal battery; (b) AirBelt; (c) DC outlet (i.e. automobile or motor boat); or (d) an AC
outlet (i.e. normal household electric). (Refer to the Power Supplies section of this Patient Manual.)
It may be necessary to initial ly connect the AC or DC FreeStyle power supply to the FreeStyle unit before the unit will
operate for the first time on battery power. Your Equipment Provider may have already performed this step for you.
Each time the FreeStyle unit is turned on , it cycles through an automatic start - up period for approximately seven minutes.
During this time, it maintains a const ant speed regardless of setting. After this period, it is normal to hear a change in
speed at the 1 and 2 settings. This variation in sound r epresents the difference s in oxygen production the unit makes at
each setting.
1.
Connect your cannula to the oxygen outlet.
2.
Lift the dust cover on the unit.
3.
Turn the FreeStyle unit on by pressing 1, 2, or 3 button on the unit’s keypad for the liter flow prescribed by your
physician. The green LED above the button selected illuminates. Each time you turn on the FreeStyle unit, a brief alarm
sounds. This indicates that FreeStyle is powered for use.
4.
To change the pulse flow setting, press the appropriate button. After the automatic start-up mode, it is normal to hear a
difference in sound as you change the settings.
5.
To turn FreeStyle off, press the button corresponding to the pulse flow setting light that is illuminated.
When FreeStyle senses inhalation, o xygen is supplied to you through your cannula.
The time required to reach maximum oxygen concentration after turning on the FreeStyle unit is approximately two
minutes.

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Power Supplies
FreeStyle can be power
e d in four different ways – the internal battery, an AC power supply, DC power supply, and an optional
AirBelt battery belt in combination with the unit’s internal battery.
1.
Internal Battery: A rechargeable internal battery is located within each FreeStyle unit. When it is fully charged, it
supplies power to the FreeStyle unit for up to 3 ½ hours. An audible alarm sounds when the battery power is getting low.
The alarm is discussed in the Alarm/Light Indicators section of this manual.
Battery Charging: To charge the internal battery, connect FreeStyle to either the AC power supply and a 100-240 volt,
50/60 Hz AC power outlet, or connect it to a DC power outlet in an automobile (boat, motor home, etc.). A discharged
battery requires approximately 3 ½ hours to fully charge. It is recommended to recharge the battery, even if only partially
depleted, as often as possible.
2.
AC Power Supply: An AC power supply allows FreeStyle to be connected to a 100-240 volt, 50/60 Hz outlet. The
power supply converts 100-240 volt AC to a DC voltage for the FreeStyle
unit. W hen FreeStyle is operated with the AC
power supply, power from the AC outlet powers the unit and recharges FreeStyle’s battery simultaneously.
3.
DC Power Supply: A DC power supply can be connected from the FreeStyle unit to an automobile’s (boat, motor home,
etc.) 12 volt DC outlet. When FreeStyle is connected to the automobile’s DC outlet, power from the automobile battery
powers the FreeStyle unit and recharges the FreeStyle
battery simultaneously.
4.
Optional AirBelt (External Battery Belt): FreeStyle can also be powered by an external battery belt. This belt can be
worn around the waist, and when used in combination with a fully charged internal battery, supplies power to FreeStyle
for up to 10 hours. The belt pack connects to the FreeStyle unit’s power inlet, and it can be recharged by connecting it to
the battery belt’s own AC power supply.
When using the AirBelt with a fully charged internal battery, the FreeStyle’s internal battery will deplete before the
AirBelt. The AirBelt must be connected to the FreeStyle unit before the FreeStyle’s internal battery is depleted. Observe
and connect the AirBelt to the FreeStyle unit before its internal battery discharges to 25% or less.
If the internal battery fully depletes and the FreeStyle unit shuts down, the unit cannot be restarted with the AirBelt.
Should this occur, connect your FreeStyle to its AC or DC power supply for a short period of time in order to provide
sufficient internal battery power to start the unit. AirBelt can then be connected to provide a dditional run time.

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Filters
Air enters FreeStyle through an air intake filter located under the cover on the lower front of the oxygen concentrator. (See
Figures 13 and 14.) This filter prevents du s t and other large particles in the air from entering the unit. Before you operate
FreeStyle, make sure this filter is clean and positioned correctly.
Figure 13: Removal of Air Intake Figure 14: Removal of Filter from
Filter Cover Filter Cover
Use only AirSep Part N o. FI144 - 1 as the air intake filter for this unit.

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Setting of the Flow Selector
The FreeStyle unit has three pulse flow settings: 1, 2, and 3, providing flows equivalent to 1-3 LPM oxygen. Lift the dust cover
on the unit’s keypad, and press the 1, 2, or 3 button, which corresponds to the oxygen pulse flow that your physician has
prescribed. (See Figures 15 and 16.)
Figure 15: Lifting Dust Cover on Keypad Display Figure 16: Pressing Flow Selection Button
It is very important to select only the prescribed level of oxygen. Change the pulse flow selection only under the guidance
of your physician.