FreeStyle Patient Manual Aug 2007

FreeStyle™

AirSep® Corporation

FreeStyle™

AirSep® Corporation

FreeStyle™

AirSep® Corporation

FreeStyle™

AirSep® Corporation

FreeStyle™ TABLE OF CONTENTS I. Why Your Doctor Prescribed Oxygen... 1-GB II. What Is the FreeStyle Portable Oxygen Concentrator?... 2-GB III. Important Safety Rules... 2-GB IV. Getting Started with your FreeStyle Portable Oxygen Concentrator... 3-GB IV. 1. Battery Charging and Installation... 4-GB IV. 2. Nasal Cannula... 5-GB V. FreeStyle Unit Components... 6-GB VI. Operating Instructions... 7-GB VII. Power Supplies... 8-GB VIII. Filter... 8-GB IX. Setting of the Flow Selector for Prescribed Oxygen Concentration... 10-GB X. Alarm/Light Indicators...11-GB X. 1. How to Respond to FreeStyle’s Alarm/Light Indicators...12-GB XI. Cleaning, Care, and Proper Maintenance... 13-GB XI. 1. Cabinet... 13-GB XI. 2. Filter... 13-GB XI. 3. Carrying Bag... 13-GB XI. 4. Alarm/Service Indicator... 14-GB XII. FreeStyle Accessories... 14-GB XIII. Reserve Oxygen Supply... 14-GB XIV. Troubleshooting... 14-GB XV. FreeStyle Specifications... 16-GB XV. 1. Classification... 17-GB XV. 2. Symbols... 18-GB XVI. Limited Warranty... 19-GB

AirSep® Corporation

GB

FreeStyle™

AirSep® Corporation

FreeStyle™

GB

AirSep’s FreeStyle™ Portable Oxygen Concentrator

This Patient Manual will acquaint you with AirSep’s FreeStyle™ Portable Oxygen Concentrator. 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 Provider will be happy to answer them for you. • If you observe that the FreeStyle unit is not working properly, if you feel ill or uncomfortable, or if you are unable to hear and/or feel the oxygen pulse, consult your Equipment Provider and/or your doctor immediately. • This unit is not to be used for life support. Geriatric, paediatric, or any other patient unable to communicate discomfort or hear or see the alarms while using this concentrator may require additional monitoring. A doctor should be consulted immediately if the patient is experiencing any signs of patient discomfort. • This device supplies high concentration oxygen that promotes rapid burning. Do not allow smoking or open flames within 1.5 metres (five feet) 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 FreeStyle outdoors with the AC power supply, connect the power supply into a Residual Current Device (RCD) outlet only. FreeStyle should not be used in the rain without proper protection of the unit.

I. Why Your Doctor Prescribed Oxygen

Many people suffer from a variety of heart, lung, and other respiratory diseases. A significant number of these patients can benefit from supplemental oxygen therapy at home, when travelling, 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 doctor has prescribed supplemental oxygen therapy because your body is not able to get enough oxygen from room air. Oxygen is a non-addictive drug, and your doctor prescribed a flow sufficient to improve your condition. Please keep in mind that unauthorised oxygen therapy can be dangerous. You must seek medical advice before you use this oxygen concentrator. The Equipment Provider who supplies your oxygen equipment will demonstrate how to set the prescribed flow rate. • It is very important to select the prescribed level of oxygen flow. Do not increase or decrease the flow until you first consult your doctor. • Use the FreeStyle Portable Oxygen Concentrator during sleep only under the recommendation of a qualified clinician.

AirSep® Corporation

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FreeStyle™

II. What Is the FreeStyle Portable Oxygen Concentrator?

Oxygen concentrators were introduced in the mid-1970s and have become the most convenient, reliable source of supplemental oxygen available today. Oxygen concentrators are the cost-effective, efficient, and safe alternative to using highpressure oxygen cylinders or liquid 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 through 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. The size and weight of traditional oxygen concentrators have limited their portability. A person who needs oxygen away from home or a hospital has used high-pressure oxygen cylinders and/or liquid oxygen. Oxygen conserving devices (OCDs) have been used to increase the length of time that cylinders last. OCDs deliver oxygen only at the beginning of inhalation, when oxygen is most beneficial. Using this technique, OCDs conserve oxygen. FreeStyle uses traditional oxygen concentration technology and combines it with oxygen conserving technology. This combination enables a significant reduction in the size of the oxygen concentrator and makes FreeStyle ultra-portable. A typical oxygen concentrator weighs more than 22kg (50 lbs). In contrast, your FreeStyle concentrator weighs only 2kg (4.4 lbs). FreeStyle delivers a flow of oxygen up to an equivalent flow of 3 LPM (litres per minute) in this lightweight package that can be easily carried and used away from home. FreeStyle operates from four different power sources. (Refer to the Power Supplies section of this manual.)

III. Important Safety Rules

Carefully review and familiarise yourself with the following important safety information about the portable FreeStyle Oxygen Concentrator. • In the event of an alarm or if you are experiencing any signs of discomfort, consult your Equipment Provider and/or your doctor immediately. • This unit is not to be used for life support. Geriatric, paediatric, 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. • When using FreeStyle in a car, boat, or other vehicle with the DC power supply, make sure that the vehicle is started and running before connecting the FreeStyle unit. If the FreeStyle unit is connected to the vehicle while starting it, jumping or charging the vehicle may cause a need to reset the FreeStyle unit’s DC power supply. If this occurs, disconnect the DC power supply from the DC outlet, restart your vehicle, and then reconnect your DC power supply into the DC outlet.

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AirSep® Corporation

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FreeStyle™

• Never use FreeStyle with the device itself located in the boot of a car. • Do not allow either the air intake filter or the air outlets to become blocked during use. • When the car in which you are using FreeStyle is turned off, disconnect and remove the unit from the car with you. Never allow FreeStyle to be stored in a very hot car or in other similar, high- or low-temperature environments. (Refer to the Specifications section in this manual.) • Do not leave a nasal cannula under bed coverings or chair cushions. If FreeStyle is turned on but not in use, the oxygen could make the material flammable. Make sure FreeStyle is off when not in use. • Although FreeStyle is a low-voltage device, do not remove its housing. Only your Equipment Provider should remove the unit covers. • AirSep recommends an alternative source of supplemental oxygen in the event of a power failure, alarm condition, or mechanical failure. Consult your doctor or Equipment Provider for the type of reserve system required. • Federal (USA) law restricts this device to sale by order of a doctor. Use FreeStyle in accordance with AirSep’s FreeStyle Patient Manual.

IV. 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 (alternative power cords available for use in various countries) • Car DC power supply

Figure 2: FreeStyle AC Power Supply/Power Cord

Figure 1: FreeStyle Unit

Figure 3: FreeStyle DC Power Supply

AirSep® Corporation

3-GB

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FreeStyle™

Optionally, you may also have an AirBelt for extended battery life. That packaging contains the following, as shown in Figure 4: • AirBelt battery belt • AC power supply (100-240 volts, 50/60 Hz) with power cord (alternative power cords available for use in various countries)

Figure 4: AirBelt and AC Power Supply/Power Cord

Before operating FreeStyle for the first time, familiarise yourself with the locations of the major components. These are illustrated in the figures on the following pages and discussed later in the manual.

IV. 1. 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/indicator(s) LEDs above the BATT button illuminate to indicate the level of internal battery charge (25-100%). To charge FreeStyle’s internal battery, simply connect its AC power supply or DC power supply into the unit’s power connection inlet (as shown in Figure 5) and the other end to its proper AC or DC power outlet. FreeStyle’s internal battery will completely recharge from its fully depleted state in approximately 3½ hours. While charging the battery, the battery gauge/indicator(s) on the FreeStyle unit’s keypad will illuminate to indicate the level of internal battery charge. When fully charged, all four LEDs will illuminate continuously. The optional AirBelt, which can increase FreeStyle’s battery duration to 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 AirBelt’s power cord (as shown in Figure 6), 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.

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AirSep® Corporation

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FreeStyle™

Figure 5: Internal Battery Charging

Figure 6: AirBelt Battery Charging

• If the power supply remains connected when the internal battery is fully charged, the four LEDs will turn off after approximately one hour.

IV. 2. 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 7.)

Figure 7: Connecting Cannula to FreeStyle’s Oxygen Outlet

AirSep® Corporation

5-GB

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FreeStyle™

AirSep recommends a nasal cannula with 2.1 m (7 ft) of tubing, AirSep Part No. CU002-1. Other lengths of tubing up to 7.62 m (25 ft) maximum, including nasal cannula, may be used. Normally, when the unit is in its carrying case, it will be necessary to first feed the cannula through the specially designed hole in the top centre of the case and then to lift the cover of the case to secure the cannula to the oxygen outlet.

V. FreeStyle Unit Components

Handle Oxygen Outlet Air Outlet Inlet for Power Connections Air Intake/Filter Cover

Figure 8: FreeStyle Exterior View - Front Dust Cover Alarm/Service Indicator Pulse Flow Indicator(s) Battery Gauge/ Indicator(s)

Flow Selection Button (Internal) Battery Button Figure 9: Close-Up of Keypad/Alarm Display

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AirSep® Corporation

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FreeStyle™

Label/Patient Instructions

Figure 10: FreeStyle Exterior View - Back

Now that you are familiar with FreeStyle’s components, review the instructions in the following section to operate the FreeStyle unit.

VI. Operating Instructions

1. Locate and position FreeStyle so that the air inlets and air outlets are not obstructed. The unit, particularly the air intake area, should be located in a wellventilated space. 2. Power the unit from (a) the internal battery; (b) AirBelt; (c) DC outlet; or (d) an AC outlet. (Refer to the Power Supplies section of this Patient Manual.) a. Use the internal battery only; or b. Use the AirBelt by connecting it to the FreeStyle unit’s inlet. c. If you are in a car, connect one end of the DC power supply into the FreeStyle unit’s inlet and the other end into the DC outlet; or d. If you are near an AC outlet, connect one end of the AC power supply into the FreeStyle unit’s inlet and the other end into the AC outlet. 3. Connect your cannula to the oxygen outlet. 4. Lift the dust cover on the unit. 5. Turn the FreeStyle unit on by pressing the 1, 2, or 3 button on the unit’s keypad for the litre flow prescribed by your doctor. 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. 6. To change the pulse flow setting, press the appropriate button. You will observe a change in compressor speed, which is normal. 7. To turn FreeStyle off, press the button corresponding to the pulse flow setting light that is illuminated. When FreeStyle senses inhalation, oxygen is supplied to you through your cannula. The duration of this pulse flow is dependent upon the flow setting. The time required to reach maximum oxygen concentration after turning on the FreeStyle unit is approximately two minutes. AirSep® Corporation

7-GB

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FreeStyle™

VII. Power Supplies

FreeStyle can be powered 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 a car (boat, motor home, etc.). It takes a minimum of 3 1/2 hours for a discharged battery 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. When 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 a car's (boat, motor home, etc.) 12-volt DC outlet. When FreeStyle is connected to the car's DC outlet, power from the car battery powers the FreeStyle unit and recharges the FreeStyle’s 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 power supply.

VIII. Filter

Air enters FreeStyle through an air intake filter located under the cover on the lower front of the oxygen concentrator. (See Figures 11 and 12.) This filter prevents dust and other large particles in the air from entering the unit. Before you operate FreeStyle, make sure this filter is clean and positioned correctly.

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AirSep® Corporation

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FreeStyle™

Figure 11: Removal of Air Intake Filter Cover

Figure 12: Removal of Filter from Filter Cover

• Use only AirSep Part No. FI144-1 as the air intake filter for this unit.

AirSep® Corporation

9-GB

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FreeStyle™

IX. Setting of the Flow Selector for Prescribed Oxygen Concentration 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 doctor has prescribed. (See Figures 13 and 14.)

Figure 13: Lifting Dust Cover on Keypad Display

Figure 14: Pressing Flow Selection Button

• It is very important to select only the prescribed level of oxygen flow. Change the pulse flow selection only under the guidance of your doctor.

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AirSep® Corporation

FreeStyle™

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X. Alarm/Light Indicators When the FreeStyle unit senses inhalation, a pulse of oxygen is sent through the nasal cannula. The green light above the selected pulse flow setting displays intermittently each time a breath is detected. Additionally, when the unit is operating on and simultaneously being charged through the AC or DC power supply, the FreeStyle unit’s battery gauge/indicator(s) display the charge level of the battery and remain on for approximately one hour after reaching a full charge. An audible alarm sounds if FreeStyle has a low battery, if the cannula is disconnected, or if performance of the unit is outside specifications. The light and audible alarm conditions are explained in detail below and summarised on the chart later in this section of the manual. • Start-Up A brief alarm sounds at start-up. FreeStyle begins to operate when the alarm stops. • Low battery As the battery power approaches a low level, a brief alarm sounds intermittently, and the yellow 25% BATT light also illuminates intermittently. When this occurs, connect FreeStyle into a DC power outlet or an AC power outlet, or change to another source of oxygen within two minutes. When FreeStyle is connected to a DC power outlet or to an AC power outlet, the unit operates while recharging FreeStyle’s battery simultaneously. The level of battery charge is indicated by the battery gauge/indicator(s). • Cannula disconnected When FreeStyle is operating but does not sense breathing within a predetermined time period, a constant alarm sounds, and the red alarm/service light illuminates. If this occurs, check the connection from the cannula to the FreeStyle unit, make sure that the nasal cannula is positioned properly on your face, and ensure that you are breathing through your nose. (Your doctor may recommend the use of a chin strap if needed.) If the alarm continues to sound, change to an alternative source of oxygen, and contact your Equipment Provider. • FreeStyle’s capacity is exceeded If your breathing rate causes the capacity of FreeStyle to be exceeded, a rapid alarm sounds, and the red alarm/service light illuminates intermittently. When this occurs, the concentration of oxygen that FreeStyle is supplying is outside the unit specifications. You should reduce any activity, change to another source of oxygen, and contact your Equipment Provider. • General malfunction If FreeStyle has a general malfunction, a rapid alarm sounds, and the red alarm light illuminates continuously. When this occurs, the concentration of oxygen that FreeStyle is supplying is outside the unit specifications. You should change to another source of oxygen and contact your Equipment Provider.

AirSep® Corporation

11-GB

GB

FreeStyle™

X. 1. How to Respond to FreeStyle’s Alarm/Light Indicators Status

Audible Alarm

Light

Indicates

Action

Indicator

Brief, continuous, (Green) pulse; at start-up continuous light

FreeStyle has been turned on.

You may begin to operate your FreeStyle unit.

Indicator

No

(Green) pulse; intermittent light

FreeStyle is Continue using delivering oxygen FreeStyle normally. as a pulse flow.

Indicator

No

Level Indicator

Battery charge level.

Charge as indicated.

Indicator

No

(Yellow) continuous light

Service required.

Return unit to Equipment Provider for inspection/service. Check the cannula connection. Ensure that you are breathing through your nose. If the alarm persists, contact your Equipment Provider.

Alarm

Continuous: Beep

(Red) alarm; continuous light

No breath detected by the unit for a predetermined time period.

Alarm

Intermittent: Beep, beep, beep...

25% (Yellow) BATT; battery indicator

Battery voltage is too low to operate FreeStyle.

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

Alarm

Rapid intermittent: Beep, beep, beep...

(Red) alarm; intermittent light

Breathing rate is exceeding the capacity of the FreeStyle unit.

Reduce activity, and/or locate and use another source of oxygen. Contact your Equipment Provider.

Alarm

Rapid intermittent: Beep, beep, beep...

(Red) alarm; continuous light

General malfunction of the FreeStyle unit has occurred.

Turn off the unit. Change to another source of oxygen, and contact your Equipment Provider.

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AirSep® Corporation

FreeStyle™

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XI. Cleaning, Care, and Proper Maintenance XI. 1. Cabinet

• Turn off the FreeStyle unit, and disconnect the power cord from FreeStyle before you clean the cabinet. • Keep the FreeStyle unit clean and free from moisture and dust. Clean the plastic housing periodically by wiping with a lint-free cloth or with a mild household cleaner applied with a damp cloth or sponge. Pay special attention to the oxygen outlet for the cannula connection to make sure it remains free of dust, water, and particles. • Do not use liquid directly on the FreeStyle unit to clean it. A list of undesirable chemical agents includes, but is not limited to, the following, according to the plastics manufacturer: alcohol and alcohol-based products (isopropyl alcohol), concentrated chlorine-based products (ethylene chloride), and oil-based products (Pine-Sol, Lestoil). These are NOT to be used to clean the plastic housing on FreeStyle. These chemicals and the cleaners that contain them will crystallise the plastic and break down the plastic’s molecular properties. • Replace the disposable cannula periodically following normal usage. Additional supplies are available from your Equipment Provider. • To prevent the AirSep warranty being void, follow all manufacturer’s instructions.

XI. 2. Filter

Air Intake Filter At least once a week, remove the cover on the lower front of the unit, and wash the air intake filter, which is positioned on the inside of the cover. Your Equipment Provider may advise you to clean it more often, depending upon your operating conditions. Follow these steps to properly clean the air intake filter: 1. Remove the filter from the air intake filter cover, and wash it in a warm solution of soap and water. 2. Rinse the filter thoroughly, and remove excess water with a soft, adsorbent towel. Ensure that the filter is dry before replacing it. 3. Replace the dry filter. • Do not operate FreeStyle without the air intake filter in place. If a second filter is provided, insert the “replacement” filter before you clean the dirty filter. • AirSep does not recommend the sterilisation of this equipment.

XI. 3. Carrying Bag To clean the carrying bag and strap, brush only with warm soapy water (do not saturate the bag), then allow to air dry. Do not machine wash or dry the bag.

AirSep® Corporation

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