AirSep FreeStyle Patient Manual
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AirSep FreeStyle Patient Manual

Portable oxygen concentrator
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See also: Service Manual , Patient Manual
Patient Manual
AirSep Corporation
401 Creekside Drive
Buffalo, New York 14228 USA
Tel: 716-691-0202
Fax: 716-691-4141
0459

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Summary of Contents for AirSep FreeStyle

  • Page 1 Patient Manual AirSep Corporation 401 Creekside Drive Buffalo, New York 14228 USA Tel: 716-691-0202 Fax: 716-691-4141 0459...
  • Page 2 FreeStyle™ 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.

  • Page 3: Table Of Contents

    Oxygen Concentrator AirSep’s FreeStyle™ Portable Oxygen Concentrator Symbols EN1-2 Why Your Physician Prescribed Oxygen EN2-3 What is the FreeStyle Portable Oxygen Concentrator? Operator Profile FreeStyle for Airline Travel – FAA-Approved Important Safety Rules EN5-11 Important Safety Rules for Optional AirBelt...

  • Page 4: Airsep's Freestyle™ Portable Oxygen Concentrator

    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...

  • Page 5: Why Your Physician Prescribed Oxygen

    FreeStyle™ Proper disposal of waste of electrical Use no oil or grease and electronic equipment required No Smoking Do not disassemble Consult instructions Type BF Equipment for use RTCA DO160 Section Safety agency for 21 Category M CAN/CSA C22.2 No.

  • Page 6: What Is The Freestyle Portable Oxygen Concentrator

    FreeStyle combines advanced oxygen concentrator technology along with oxygen conserving technology for the world’s smallest and lightest portable oxygen 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.

  • Page 7: Operator Profile

    FreeStyle™ Operator Profile: AirSep’s Concentrators are intended to supply supplemental Oxygen to users suffering from discomfort due to ailments which effect the efficiency of ones lungs to transfer the oxygen in air to their bloodstream. POC’s provide the convenience of using a non-delivery POC system rather than delivery system (O2 tank) which makes the user relatively self-sufficient in terms of in-home use, ambulation (both within and outside of the home) mobility and overall lifestyle.

  • Page 8: Important Safety Rules

    Use no oil, grease, or petroleum-based or other flammable products with the oxygen-carrying accessories or the FreeStyle unit. Only water based, oxygen compatible lotions or salves should be used. Oxygen accelerates the combustion of flammable substances.
  • Page 9 FreeStyle™ The incorrect use of the FreeStyle battery can cause the battery 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.

  • Page 10: Troubleshooting

    Federal (USA) law restricts this device to sale or rental by order of a physician or other licensed health care provider In the event of an alarm or you observe that FreeStyle is not working properly; consult the Troubleshooting section in this manual.
  • Page 11 When the automobile in which you are using the FreeStyle unit is turned off, disconnect and remove the unit from the automobile with you. Do not store FreeStyle in a very hot automobile or in other similar, high-or low-temperature environments. Operating or storing the unit outside the normal temperature range can affect the performance of the FreeStyle.

  • Page 12: Battery Charging

    This is a normal condition and is intended for safe charging. The FreeStyle battery does not need to be fully discharged before recharging. It is recommended to charge the FreeStyle battery after each use.
  • Page 13 Provider may have already performed this step for you. Use only AirSep Part No. FI144-1 for air intake filter for this unit. 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.
  • Page 14 Do not attempt any maintenance other than the possible solutions listed within this manual. The lithium ion 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 regardless of the battery’s capacity level after use.

  • Page 15: Important Safety Rules For Optional Airbelt

    Replace safety cap on AirBelt cord when not in use. Do not attempt to charge the optional AirBelt with the FreeStyle Universal AC/DC power supply, or AirBelt can be damaged. Use only the AirBelt power supply provided to charge AirBelt.

  • Page 16: Getting Started With Your Freestyle Portable

    [Read the Important Safety Rules section before operating this equipment.] 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.
  • Page 17 (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 through the loops on the FreeStyle carrying case. (See Figure 6.) The optional accessories bag (part number MI320-1) enables even...

  • Page 18: 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%).
  • Page 19 FreeStyle™ The FreeStyle battery does not need to be fully discharged before recharging. It is recommended to charge the FreeStyle battery after each use. Charging may take several minutes after connecting the power to initiate, depending on the battery’s internal operating temperature.

  • Page 20: Nasal Cannula

    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 AirSep recommends a nasal cannula with 7 ft (2.1 m) of tubing, AirSep Part No.

  • Page 21: Freestyle Unit Components

    Consult your licensed health care provider to determine how often the cannula should be replaced. Make sure the cannula is fully inserted and secure. This ensures that the FreeStyle unit can properly detect inspiration for oxygen delivery. FreeStyle Unit Components...
  • Page 22 Label/Patient approved to comply Instructions with FAA standards. 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. ® AirSep Corporation EN-19...

  • Page 23: Operating Instructions

    Connect your cannula to the oxygen outlet. Lift the dust cover on the unit. 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.

  • Page 24: Power Supplies

    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.

  • Page 25: Freestyle™ Universal Ac/Dc Power Supply

    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.
  • Page 26 For all procedures below, it is recommended that you first connect the universal power supply to the FreeStyle POC inlet, as shown in Figure 14. Be sure to properly connect to the unit by ensuring that the carrying case alignment with the FreeStyle unit inlet allows you to obtain a secure connection so that the cord “locks”...
  • Page 27 Connect the opposite end of the AC electrical cord to the wall or other appropriate electric outlet, as shown in Figure 16. To operate the POC, press the FreeStyle [1], [2], or [3] setting on the unit’s top panel, as determined by your prescription.
  • Page 28 Connect the DC power cord to the motor vehicle’s DC outlet, as shown in Figure 18. To operate the POC, press the FreeStyle [1], [2], or [3] setting on the unit’s top panel, as determined by your prescription. To turn the unit off, press the setting associated with the LED illuminated above it.
  • Page 29 Insert the 4-pin connection to the airline passenger DC outlet optionally available at your seat. To operate the POC, press the FreeStyle [1], [2], or [3] setting on the unit’s top panel, as determined by your prescription. To turn the unit off, press the setting associated with the LED illuminated above it.

  • Page 30: Filters

    Filters Air enters FreeStyle through an air intake filter located under the cover on the lower front of the oxygen concentrator. (See Figures 21 and 22.) 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.

  • Page 31: Setting Of The Flow Selector

    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.

  • Page 32: Alarm/Light Indicators

    Change the pulse flow selection only under the guidance of your physician. 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.
  • Page 33 FreeStyle™ In the event of an alarm or you observe FreeStyle is not working properly; consult the Troubleshooting section in this manual. If you cannot resolve the problem, consult your Equipment Provider. If you feel discomfort or are experiencing a medical emergency, seek medical assistance immediately.

  • Page 34: How To Respond To Freestyle's Alarm/Light Indicators

    FreeStyle™ General malfunction If FreeStyle has a general malfunction, 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.
  • Page 35 Contact your Equipment Provider. Alarm Rapid (Red) alarm; General malfunction Turn off the unit. intermittent: continuous light of the FreeStyle unit Change to another Beep, beep, has occurred. source of oxygen, and beep… contact your Equipment Provider. ® EN-32...

  • Page 36: Cleaning, Care, And Proper Maintenance

    Turn off the FreeStyle unit, and disconnect the power cord from FreeStyle before you clean the cabinet. 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...

  • Page 37: Filter

    Ensure that the filter is dry before replacing it. 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.

  • Page 38: Carrying Bag

    Figure 25: Indicator of Required Inspection/Service Alarm/Service Indicator When the alarm service/indicator illuminates (yellow), it is time for your FreeStyle unit to be inspected/serviced by your Equipment Provider. After any necessary service and the performance is verified by the Equipment Provider, the alarm service/indicator light will be reset.

  • Page 39: Freestyle Accessories

    FreeStyle Accessories For proper performance and safety, use only these listed accessories supplied by AirSep through your Equipment Provider. Use of accessories not listed below could adversely affect the performance and/or safety of the Freestyle Portable Oxygen Concentrator Description/Part Number...
  • Page 40 MI078-1 AirBelt Extender New Velcro Version MI284-1 Shoulder Harness option enables converting the supplied FreeStyle carrying bag to a backpack FI144-1 Air Intake Filter Use of cables and adapters other than those specified, with the exception of cables and adapters sold by the manufacturer of...

  • Page 41: Materials In Direct Or Indirect Contact With The Patient

    Troubleshooting The FreeStyle product is designed for years of trouble-free use. If your FreeStyle Portable Oxygen Concentrator fails to operate properly, refer to the chart on the following pages for possible causes and solutions and, if needed, consult your Equipment Provider.
  • Page 42 FreeStyle™ Problem Probable Cause Solution FreeStyle does not Battery is discharged. Power the unit through the operate when a pulse DC outlet, or an AC outlet. flow selection button is Malfunction. pressed. Contact your Equipment Provider, and change to another source of oxygen as necessary.
  • Page 43 Reduce activity, and then condition, and the (red) exceeded the capacity turn unit off and back on alarm light illuminates of the FreeStyle unit. again to reset unit. If intermittently. necessary, change to another source of oxygen as available and contact your Equipment Provider.
  • Page 44 FreeStyle™ Problem Probable Cause Solution Unit alarms while in No power to the unit if Disconnect the Universal automobile and battery depleted and AC/DC power supply from connected to the DC DC outlet not charging. the automobile outlet, outlet. restart the automobile,...

  • Page 45: Freestyle Specifications

    FreeStyle™ FreeStyle Specifications Oxygen 1-3 pulse settings; equivalent to a continuous flow of 90% Concentration:* oxygen +5.5/-3% Flow Rate Settings: 1, 2 & 3 LPM (equivalent to continuous flow) Settings 1 through 3 ±10% Dimensions: 8.6 in. high x 6.1 in. wide x 3.6 in. deep (21.8 cm high x 15.5 cm wide x 9.1 cm deep)
  • Page 46 Guidance and manufacturer’s declaration ± electromagnetic immunity The FreeStyle is intended for use in the electromagnetic environment specified below. The customer or the user of the FreeStyle should assure that it is used in such an environment. IEC 60601 test Electromagnetic environment ±...
  • Page 47 FreeStyle™ Guidance and manufacturer’s declaration ± electromagnetic immunity The FreeStyle is intended for use in the electromagnetic environment specified below. The customer or the user of the FreeStyle should assure that it is used in such an electromagnetic environment. IMMUNITY...
  • Page 48 Guidance and manufacturer’s declaration – electromagnetic emissions The FreeStyle is intended for use in the electromagnetic environment specified below. The customer or the user of the FreeStyle should assure that it is used in such an environment.

  • Page 49: Classification

    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 Patient Manual. Degree of safety of application in the presence of flammable anesthetic gases: Equipment not suited for such application.

  • Page 50: Limited Warranty

    The battery is warranted for one year. AirSep Corporation’s obligations under this warranty are limited to the repair or replacement of any such item of equipment (or part thereof) shown to be defective or, at AirSep Corporation’s option, to refund the purchase price of any such defective item of equipment.
  • Page 51 FreeStyle™ ® EN-48 AirSep Corporation MN131-1 rev. B - 02/13...
  • Page 52 Manufactured by: AirSep Corporation Buffalo, NY 14228-2085 USA |MN131-1_B2~ MN131-1 Rev B ® AirSep Corporation MN131-1 rev. B - 02/13...

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