AirSep FreeStyle 5 User manual

FreeStyle
™
5 P or table
Oxygen C onc en tra t or
Service M anual

FreeStyle 5 Service Manual MN179-1 D
Expedited Product Warranty Check service is available at 800-482-2473
MN179-1 Rev D

FreeStyle 5 Service Manual MN179-1 D i – table of contents
Table of Contents
Section 1.0
I n troduction
Section 2.0
Operation Check and
1.1 E quipmen t Provider R esponsibilit y
1.2
I mpor tan t Notice and Symbol Explanations
1.3 Definitions of Symbols
1.4 FreeStyle 5 Specifications
1.5 FreeStyle 5 Classifications
T est of Oxygen C onc en tration
2.1 Description of Oper a tion
2.2 Operation Check
2.3 Alarm S y stem
2.3.1 S tar t -up
2.3.2 Battery S ta tus
2.3.3
L o w Ba tt er y
2.3.4
Discharged Ba tt er y
2.3.5
Battery Char g ing
2.3.6
Battery Fully Char ged
2.3.7
Cannula Disc onnec t
2.3.8
Performance W ar ning
2.3.9 FreeStyle 5 Capacity Ex c eeded
2.3.10 General M alfunc tion
2.4
Oxygen C onc en tr a tion T est and
Specification

Section 3.0
Patient I nstructions
3.1 General
I nstructions
3.1.1 Connecting to external Power
3.1.2 Optional
AirBelt Battery
3.2
R outine Maintenance by the Patient
3.2.1 Cleaning the
Air I n take
GrossParticle Filter
3.2.2 Alarm/Service
I ndica t or
3.2.3 Usage with Extended
T ubing
3.2.4 Usage at Night
Section 4.0
E quipmen t P r o vider
M ain t enanc e
4.1 R outine Maintenance
4.1.1 Air I n take / Gross Particle Filter
4.1.2 Product Filter R eplac emen t
4.1.3 Compressor Servicing
4.1.4 R ec or ding M ain t enanc e
4.2 I nf ection C on tr ol
4.3 Cleaning and Preparing for New Patient Use
ii – table of contents MN179-1 D FreeStyle 5 Service Manual

FreeStyle 5 Service Manual MN179-1 D iii – table of contents
Section 5.0
Service
5.1 C omponents
5.2
Housing R emo v al
5.2.1 R emo ving Front Cover
5.2.2 R emo ving Back Cover
5.3
I n t er nal Battery R eplac emen t
5.4
PSA R emo v al
5.5
Compressor R eplac emen t
5.5.1 Compressor Assembly R emo v al
5.5.2 Compressor Assembly I nstalla tion
5.6 Product Manifold R eplac emen t
5.7
Solenoid V alv e R eplac emen t
5.8
Adsorbent B ed R eplac emen t
5.9
Feed/Waste Manifold R eplac emen t
5.10
Measuring System P r essur e
5.11
Circuit B oar d R eplac emen t
5.12
Motor Controller B oar d R eplac emen t
5.13
Control/KeyPanel R eplac emen t
5.14
Fan R eplac emen t

Section 6.0
Typical Pressure Profiles
6.1 Pressure Profile Quadrant
Section 7.0
T r oubleshooting
7.1 General T r oubleshooting
7.2 T r oubleshooting Chart
Section 8.0
R ec ommended Tools
8.1 Tools f or FreeStyle 5 Service and Maintenance

MN179-1 FreeStyle 5 Service Manual Rev D
1.0 I n troduction
1.1
E quipmen t Provider R esponsibilit y
All EquipmentProvidersof the FreeStyle™5 PortableOxygen Concentrator must
assume responsibilities for handling,operationalcheck-out,patient instruction,and
maintenance. These responsibilities are outlined below and throughoutthis manual.
This unit is not to be used for life support. Geriatric, pediatric, or any other patients unable to
communicate discomfort while using this unit may require additional monitoring. Patients with
hearing and/or sight impairment(s) may need assistance with monitoring alarms.
As an Equipment Provider, you must do all of the following:
■Inspect the condition of each FreeStyle 5 unit immediately upon
delivery to your business location. Note any sign of damage,
external or internal, on the delivery receipt, and report it
directly to both the freight company and AirSep Corporation
immediately.
■Check the operation of each FreeStyle 5 unit before delivery to a
patient. Always operate the unit for a minimum of 10 minutes,
and check that the oxygen concentration level is within
specifications, as described in Section 5 of this manual.
■Deliver FreeStyle 5 units only to patients authorized by a physician’s
prescription. FreeStyle 5 must not be used as a life-supporting
device.
■Instruct patients how to use FreeStyle 5 in conjunction with the
Patient Manual.
■Instruct patients to notify their physicians and/or Equipment
Providers if they experience any signs of discomfort.
■Be available to service each patient at any time.
■Maintain FreeStyle 5 in accordance with Section 4.0.
■Repair components and replace parts only as outlined in this
manual. Use only AirSep parts for replacement in FreeStyle 5 Oxygen
Concentrators.

MN179-1 FreeStyle 5 Service Manual Rev D
1.2 I mpor tan t Notice and Symbol Explana tions
As you review both the FreeStyle 5 Patient Manual and this FreeStyle 5 Service
Manual, pay special attention to the WARNING, CAUTION, and NOTE messages.
They identify safety guidelines or other important information as follows:
DO NOT OPERATE THIS EQUIPMENT WITHOUT FIRST READING AND UNDERSTANDING THIS
MANUAL. IF YOU ARE UNABLE TO UNDERSTAND THE WARNINGS AND INSTRUCTIONS,
CONTACT YOUR EQUIPMENT PROVIDER BEFORE ATTEMPTING TO USE THIS EQUIPMENT;
OTHERWISE, INJURY OR DAMAGE MAY RESULT.
Smoking while using oxygen is the number one cause of fire injuries and
related deaths. You must follow these safety warnings:
Do not allow smoking, candles, or open flames in the same room with the device or
within 5 feet (1.52 meters) of the oxygen-carrying accessories.
Smoking while wearing an oxygen cannula may cause facial burns and possibly death.
Removing the cannula and putting it on bedding, sofas, or other cushion material will
cause a flash fire when exposed to a cigarette, heat source, or flame.
If you smoke, these 3 steps may save your life:
turn off the oxygen concentrator, take off the cannula, and leave the room where this
device is located.
“No Smoking – Oxygen in Use” signs must be prominently displayed in the home, or
where the oxygen concentrator is in use. Patients and their caregivers must be
informed about the dangers of smoking in the presence of, or while using, medical
oxygen.
Warning –Describes a hazard or unsafe
practice that if not avoided can result in
severe bodily injury, death or property
damage
Caution –Describes a hazard or unsafe
practice that if not avoided can result in
minor bodily injury or property damage
Note – Provides information important
enough to emphasize or repeat

MN179-1 FreeStyle 5 Service Manual Rev D
1.3 Definitions of S ymbols
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 5 Portable Oxygen
Concentrator.
Symbol Description Symbol Description
Warning –Describes a hazard or unsafe
practice that if not avoided can result in
severe bodily injury, death or property
damage
Class II Equipment, double insulated
Caution –Describes a hazard or unsafe
practice that if not avoided can result in
minor bodily injury or property damage
Safety agency for CAN/CSA C22.2 No.
60601-1-08 M90 for medical electrical
equipment
Note – Provides information important
enough to emphasize or repeat
Keep unit and accessories dry
Consult the accompanying
documents
Proper disposal of waste of electrical and
electronic equipment required
Use no oil or grease
Do not disassemble
No smoking Consult instructions for use
Type BF equipment Do not expose to open flames
Fragile - handle with care This side up
FAA-Approved POC
See Instructions
RTCA/DO-160 Section 21
Category M Compliant
RTCA DO160 Section 21 Category M
Compliant. FAA SFAR 106
requirement

MN179-1 FreeStyle 5 Service Manual Rev D
1.4 FreeStyle 5 Specifications
Oxygen
Concentration:*
1-5 pulse settings; equivalent to a continuous flow of 90% oxygen +5.5 / -3%
Flow Rate Settings: 1 ,2, 3, 4 & 5 LPM (equivalent to continuous flow)
Setting 1±15%. Settings 2 through 5±10%
Dimensions: 10.7 in. high x 6.6 in. wide x 4.4 in. deep (27.2 cm high x 16.8 cm wide x 11.2
cm deep)
Weight:
6.2 lb (2.8 kg); 1.8 lb (.8 kg) optional AirBelt
Power: AC Power Supply: Input: 100-240VAC, 50-60Hz, 2A | Output: 15V
DC Power Supply: Input: 12VDC-24VDC, 15A max | Output: 15V, 8A max
Battery duration
(Rechargeable
lithium Battery)
5 LPM – 1 hour; 4 LPM – 1 hour, 15 minutes; 3 LPM – 1 hour, 30 minutes; 2
LPM – 2 hours; 1 LPM – 3 hours
Optional AirBelt when combined with the internal battery:
5 LPM – 2 hours, 30 minutes; 4 LPM – 3 hours; 3 LPM – 3 hours, 30
minutes; 2 LPM – 4 hours, 30 minutes; 1 LPM – 7 hours
Battery recharge
time:
3 hours, 15 minutes; optional AirBelt: 3 hours, 30 minutes
Initial startup time
2 minutes
Battery cycle life: Approximately 300 cycles, then 80% capacity or below.
Audible alarms and
pulse visual
indicators:
Start-up – audible and visual (GREEN indicator light);
Pulse flow – visual (GREEN indicator light);
Battery condition – battery level (GREEN indicator lights);
Battery Low – audible and visual (YELLOW alarm light);
Battery shutdown – audible and visual (YELLOW alarm light);
Cannula disconnect- audible and visual (YELLOW alarm light);
System overdraw – audible and visual (YELLOW alarm light);
General malfunction – audible and visual (RED alarm light).
**Temperature
range:
Operational temperature: 41°F to 104°F (5°C to 40°C)
(Up to 95% RH (non-condensing)
Storage temperature: -4°F to 140°F (-20°C to 60°C)
**Max Operational
Altitude:
up to 12,000 ft (3,657.6 m) (483mmHg) Higher altitudes may affect
performance
* Based on an atmospheric pressure of 14.7 psi (101 kPa) at 70°F (21°C)
** Operating outside of these specifications can limit the concentrator’s ability to meet Oxygen Concentration specifications at higher liter flow
rates.

MN179-1 FreeStyle 5 Service Manual Rev D
1.5 FreeStyle 5 Classifications
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 Medical Electrical Equipment – Part 1: General Requirements for Safety
Tested to be in compliance with applicable requirements of the Standard,
CAN/CSA C22.2 No. 60601-1-08 M90 Medical Electrical Equipment
Protection against potential electromagnetic or other interference between the equipment and other devices.
Tested to be in compliance with:
EN 60601-1-2 Medical Electrical Equipment, Part 1: General Requirements for Safety-
Collateral Standard: Electrical Compatibility - Requirements and Tests
RTCA/DO160 Airborne Equipment, Sec. 21, Emission of Radio Frequency Energy
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 5 Patient
Manual.
Degree of safety of application in the presence of flammable anesthetic gases:
Equipment not suited for such application.
Mode of operation:
Continuous duty.

MN179-1 FreeStyle 5 Service Manual Rev D
2.0 Operation Check and T est of Oxygen C onc en tration
2.1 Description of
Oper a tion
Air enters the FreeStyle 5 Oxygen Concentrator through an external air intake /
gross particle filter. This filteredair enters the compressor via a muffler that quiets
the compressor’s suction sound.
Next, a two-way solenoid feed valve directs the air into one of two sieve beds that
contain molecular sieve. The unique property of molecular sieve enables it to
physically attract (adsorb) nitrogen when air passes through this material, thereby
separating the nitrogen from the oxygen in ambient air.
There are two sieve beds: While one produces high-concentration oxygen, the
other is purged of the nitrogen it adsorbed (collected) while it made oxygen.
In addition to the molecular sieve beds that allow oxygen to be separated from
air, FreeStyle 5 contains an Oxygen Conserving Device (OCD) valve that
controls delivery of high-concentration oxygen to the patient at the point in the
breathing cycle when the patient starts to inhale.
FreeStyle 5 delivers a gas consisting of 90% (+5. 5 -3%) oxygen
at pulse flow rates equivalent from approximately1–5 LPM.
2.2 Operation Check
AirSep tests every FreeStyle 5 Oxygen Concentrator thoroughly after
manufacture. You must perform the following test to ensure that no damage
occurred in shipping or handling.
1. Open and inspect all cartons upon delivery. Unpack the unit and
remove it from the carton. Inspect the unit itself for damage. If
the exterior of a unit’s carton is damaged, or if the unit itself is
damaged, note this on the freight bill signed by the driver.
2. Connect the power supply to the unit, and turn the unit on by pressing
flow setting [5]. Check to see that the following sequence occurs:
a. A brief, continuous alarm sounds to indicate that FreeStyle 5
has been turned on.
b. The compressor runs.
c. After a 10 second start up is complete,
the fan turns on.
d. Exhaust air flowsfrom the unit.
3. Perform an oxygen concentration test, as described in Section 2.4.

MN179-1 FreeStyle 5 Service Manual Rev D
2.3 Alarm S y stem
An audible alarm sounds if FreeStyle 5 has a low battery, senses no
inspiration, high temperature ,system overdraw, high or low pressure. If an
alarm sounds, observe which lights are on. The visual and audible alarm
conditions are explained in detail below.
2.3.1 Start-Up
A one-second, audible alarm sounds to indicate start-up. FreeStyle 5 begins
to operate when the alarm stops.
2.3.2 Battery Status
To check the level of charge of the internal battery, press the BATT button on
FreeStyle 5’s keypad. The battery gauge / indicator(s) LEDs above the BATT
button illuminate from 25-100% to indicate the level (capacity) of the internal
battery. At less than 25% capacity, the 25% LED blinks.
2.3.3 Low Battery
As the battery power approaches a low level, a ½ second beep is emitted every
five seconds, and a yellow LED on the battery gauge / indicator(s) will blink
for a ½-second every five seconds. When this occurs, the patient is instructed
to connect the FreeStyle 5 AC or DC power supply or change to another
source of oxygen. The low battery alarm will continue for approximately 2
minutes before FreeStyle 5 stops operating.
2.3.4 Discharged Battery
When the battery is discharged, the unit shuts down. Before this occurs, a ½
second beep sounds every ½ second and the yellow battery LED blinks at the
same rate until any one of the 1-5 settings on the keypad are pressed. After the
alarm is turned off, connect the FreeStyle 5 unit to its AC or DC power supply
or change to another source of oxygen immediately. When the FreeStyle 5
unit is connected to the AC or DC power supply, FreeStyle 5 operates and
the internal battery recharges simultaneously.

MN179-1 FreeStyle 5 Service Manual Rev D
2.3.5 Battery Charging
To check the level of charge of the battery, press the button on the battery’s keypad.
The battery gauge/indicator(s) illuminate to indicate the level of battery charge (25-100%).
To charge the FreeStyle 5’s internal battery:
 Connect its AC power supply or DC (auto) power supply into the
unit’s power receptacle located on the right side of the FreeStyle
5 unit, and the other end to its proper AC or DC power outlet.
(See Figure 3.1).
The FreeStyle 5 internal battery will completely charge from a fully
depleted state in approximately 3 hours and 15 minutes.
 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 (½ second).
 The LED will continue toblinkuntila25%capacity isreached.The
LED will then turn solid.
 Each of the four LEDs, 25-100%, will blink as stated above, then
turn solid when they reach their capacity.
 Once all LEDs illuminate solid, the battery is fully charged and the
LEDs will remain on solid for approximately 1 ½ hours, then all
four LEDs will turn off.
 If the AC or DC power supply is not connected, the LEDs will turn off within five
seconds.
Depending upon the temperature of the FreeStyle 5 battery, it can take several minutes for the
charging cycle to start after connecting to power. This is a normal condition and is intended for safe
charging.
The lithium ion rechargeable battery that is used in the FreeStyle 5 unit does not need
to be fully depleted before recharging. It is recommended to charge the battery regardless of the
battery’s capacity level after use.
The battery will charge when the unit is off as well as while the unit is running off the AC or DC
power supply.
Lithium batteries may permanently lose capacity when exposed to extremely hot temperatures with
the batteries fully charged or completely depleted. For extended storage, it is recommended that
batteries be charged 25 to 50% and remain within a temperature range of 73°F (23°C).

MN179-1 FreeStyle 5 Service Manual Rev D
2.3.6 Battery Fully Charged
When FreeStyle 5 is connected to an AC or DC outlet and is either in
operation or is off, the green 100% battery gauge/indicators displays to
indicate that the battery is fully charged.
2.3.7 Cannula Disconnect (No inspiration detected)
When FreeStyle 5 is operating and does not sense breathing within 15,
consecutive minutes, a constant alarm (beep) sounds, and the yellow alarm
light illuminates simultaneously. If this occurs, check the connection from
the cannula to the FreeStyle 5 unit, make sure that the nasal cannula is
positioned properly on your face, and ensure that you are breathing
through your nose. (Your physician may recommend the use of a chin strap if
needed.)
If the alarm continues to sound, the patient should change to an alternate
source of oxygen and contact the Equipment Provider.
2.3.8 Performance Warning
The performance of FreeStyle 5 can be affected by two conditions.
1) If the user’s breathing rate causes the FreeStyle 5 unit’s capacity to be exceeded.
The amount of oxygen that FreeStyle 5 supplies is dependent on the flow control switch
setting and the breathing rate. If the breathing rate is too fast for the flow selector setting,
the capacity of FreeStyle 5 can be exceeded. The patient should reduce activity or consider
locating another source of oxygen.
2) The second condition that can result in decreased performance is a general malfunction
(i.e. High temperature, High or Low pressure).
If either of these events occurs, an alarm sounds every five seconds. If
breathing is too fast for the flow selector setting and FreeStyle 5 capacity is
exceeded, the yellow light flashes. If a general malfunction occurs,
a continuous red alarm light appears
2.3.9 FreeStyle 5 Capacity Exceeded
When the patient’s breathing rate has caused the capacity of FreeStyle 5
to be exceeded, a rapid intermittent beep, beep, beep alarm sounds with
an intermittent yellow alarm light. When this occurs, oxygen
concentration is outside specifications.Thepatient shouldreduce activity,
then if necessary use another source of oxygen as available. Contact your
Equipment Provider.

MN179-1 FreeStyle 5 Service Manual Rev D
2.3.10 General Malfunction
If a general malfunction of the FreeStyle 5 unit occurs, Two ½ second alarms
sound every 5 seconds, and the red ALARM light turns on. When this occurs,
oxygen concentration is outside specifications.The patient should change to
another source of oxygen and contact the Equipment Provider.
2.4 Oxygen
C onc en tr a tion T est and Specifica tion
To ensure that FreeStyle 5’s oxygen output is within specification, you must
perform an oxygen concentration test. Test the unit upon delivery to a patient and
at periodic intervals. Equipment Providers, based upon their own expertise and
documentation, may establish and implement their own protocol to check oxygen
concentration.
1.Connect the FreeStyle 5 Oxygen Concentrator using an AirSep-supplied AC
adapter only (AirSep Part No.PW020-1) to a 100-240 volt, 50/60 Hz electrical
outlet.
2.Turn unit on by pressing setting 5 on keypad.
3. Simultaneously press and hold settings 1 and 5 for 10 seconds. After 10 seconds, the
alarm will sound and the LEDs above each flow setting will illuminate verifying auto pulse
mode.
Control Panel
Flow Settings 1 - 5
Figure 2.1
4. Allow unit to warm-up for 2 minutes before recording oxygen concentration.
5. Connect a calibrated oxygen analyzer to the oxygen outlet and record the
unit’s concentration. The specification in test mode is 87% or higher.

MN179-1 FreeStyle 5 Service Manual Rev D
3.0 Patient
I nstructions
3.1 General
I nstructions
It is important that patients thoroughly understand how to operate AirSep’s FreeStyle 5 unit.
This enables proper treatment as prescribed by a qualified,licensed physician. You must
explain that the purpose of this therapy is to alleviate symptoms. If patients experience any
discomfort or if the unit alarms, they must notify their Equipment Provider and/or physician
immediately.
You, as the Equipment Provider, are responsible to ensure that each patient receives the
FreeStyle 5 Patient Manual. Explain each step in the operation of the unit to the patient with
reference to the patient manual.
3.1.1 Connecting to External Power
When connecting the AC or DC power supply to the FreeStyle 5 unit, be certain to first
properly 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 FreeStyle 5’s inlet connection. These must be aligned, and
the button on the power cord must be pressed in for removal. This ensures that neither the unit
nor the power accessories are damaged.
FreeStyle 5
unit’s power
inlet
Press to remove
power cord.
“D”-shaped power cord plug
connects to the FreeStyle 5
unit’s “D”-shaped power inlet.
Figure 3.1
3.1.2Optional AirBelt™ Battery
Instruct patients that connecting an optional AirBelt to the unit by inserting
the power into the unit’s power inlet provides additional total run time, per the specifications.
Note that the unit battery must still have a charge remaining before the external AirBelt is
connected. The patient should be advised to not fully deplete the unit battery as a small amount
of power is needed to engage the AirBelt.
To charge the AirBelt battery:
1) Release safetycap from end of the AirBelt cord.

MN179-1 FreeStyle 5 Service Manual Rev D
2. Connect the AC/DC power supply (included with the AirBelt Accessory kit)
to the end of AirBelts power cord as shown in Figure 3.2.
3. Connect the AirBelt power supply to an AC electrical outlet to recharge.
Replace safety cap on AirBelt cord when not in use.
Do not attempt to charge the optional AirBelt with the any other power supply or the AirBelt can
be damaged. Use only the AirBelt power supply provided to charge AirBelt.

The FreeStyle 5 AirBelt will completely recharge from its fully depleted state in approximately 3 ½ hours.

While charging a fully discharged battery, the LED will continue to blink until 25% capacity is reached. The
LED will then turn solid.

Each of the four LEDs, 25% -100%, will blink as stated above, then turn solid when the battery reaches
it’s 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.
Depending upon the temperature of the AirBelt battery, it can take several minutes for the
charging cycle to start after connecting to power. This is a normal condition and is intended for
safe charging.
Lithium batteries may permanently lose capacity when exposed to extremely hot temperatures with
the batteries fully charged or completely depleted. For extended storage, it is recommended that
batteries be charged 25 to 50% and remain within a temperature range of 73°F (23°C) +/- 2°C.
The incorrect use of AirBelt can cause it to 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.
Figure 3.2: AirBelt Battery Charging set up
AirBelt
AC/DC Power Supply
Connecting the AirBelt cord to the
power supply cord

MN179-1 FreeStyle 5 Service Manual Rev D
AirBelt does not need to be fully discharged before recharging. It is recommended to charge it
after each use.
If the AirBelt power supply remains connected when it is fully charged, the four LEDs will turn off
within ½ hour.