AirSep FreeStyle User Manual
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Summary of Contents for AirSep FreeStyle
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Page 1: Table Of Contents
Oxygen Concentrator Symbols EN1-2 Why Your Physician Prescribed Oxygen What is the FreeStyle Portable Oxygen Concentrator? Operator Profile FreeStyle for Airline Travel – FAA-Approved Important Safety Rules EN5-10 Getting Started with Your FreeStyle Portable Oxygen Concentrator EN11-12 Battery Charging EN13-14... - Page 2 TABLE OF CONTENTS ® AirSep FreeStyle™ Portable Oxygen Concentrator Cleaning, Care, and Proper Maintenance EN29 EN29 Cabinet EN30 Filter EN31 Carrying Bag EN31 Alarm/Service Indicator FreeStyle Accessories EN32 Materials in direct or indirect contact with the patient EN33 Reserve Oxygen Supply...
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Page 3: Airsep's Freestyle Portable Oxygen Concentrator
This Patient 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 Provider will be happy to answer them for you. -
Page 4: Why Your Physician Prescribed Oxygen
Symbol Description Symbol Description No Smoking Do not disassemble Type BF Equipment Consult instructions for use Safety agency for CAN/CSA RTCA DO160 Section 21 C22.2 No. 60601-1-08 M90 RTCA/DO-160 Section 21 Category M Compliant. FAA for medical electrical Category M Compliant SFAR 106 requirement equipment Safety agency for CAN/CSA... -
Page 5: What Is The Freestyle Portable Oxygen Concentrator
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. -
Page 6: Freestyle For Airline Travel - Faa-Approved
FreeStyle for Airline Travel – FAA-Approved 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... -
Page 7: Important Safety Rules En5-10
Important Safety Rules Carefully review and familiarize yourself with the following important safety information about the portable FreeStyle Oxygen Concentrator. “No Smoking – Oxygen in Use” signs must be prominently displayed in the home, or where oxygen is in use. Patients and their caregivers must be informed about the dangers of smoking in the presence of, or while using, medical oxygen. - Page 8 Do not use liquid directly on the unit. A list of undesirable chemical agents includes but is not limited to the following: alcohol and alcohol-based products, concentrated chlorine-based products (ethylene chloride), ® ® and oil- based products (Pine-Sol , Lestoil ).
- Page 9 Properly secure, belt or otherwise restrain the oxygen concentrator when in a vehicle during transport to prevent damage or injury. If the oxygen concentrator has been dropped, damaged, or exposed to water, please contact your home care provider for inspection or possible repair of the device. Do not use the oxygen concentrator if it has a WARNING damaged power cord or plug.
- Page 10 The Manufacturer recommends an alternate source of supplemental oxygen in the event of a power outage, alarm condition, or mechanical failure. Consult your physician or Equipment Provider for the type of reserve system required. It is very important to select only the prescribed level of oxygen. Do not change the flow selection CAUTION unless you have been directed to do so by a licensed clinician.
- Page 11 There is never a danger of depleting the oxygen in a room when you use your Oxygen Concentrator unit. AirSep offers the OxySafe as an optional accessory. This is intended to be used in conjunction with the FreeStyle concentrator. For customers in regions requiring compliance to EN ISO 8359:1996- Ammendment1:2012, this accessory will meet this need.
- Page 12 Important Safety Rules for Optional AirBelt For oxygen concentrators equipped with the optional Airbelt : 1. The incorrect use of AirBelt can cause the battery to get hot, ignite, and can 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.
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Page 13: Getting Started With Your Freestyle Portable Oxygen Concentrator En11-12
Getting Started with Your FreeStyle Portable Oxygen Concentrator Figure 2: FreeStyle Universal AC/DC Power Supply/Power Cord The FreeStyle packaging contains the following items, as shown in Figures 1-3. If any are missing, Figure 1: FreeStyle Unit contact your Equipment Provider. - Page 14 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 through the loops on the FreeStyle carrying case.
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Page 15: Battery Charging
Power Inlet 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. - Page 16 25 to 50% and remain within a temperature range of 73°F ± 35°F (23°C ± 2°C). 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 • Universal AC/DC power...
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Page 17: Nasal Cannula
[Read the Important Safety Rules section before operating this equipment.] 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). -
Page 18: Freestyle Unit Components
FAA standards. 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. MN131-1 rev C... -
Page 19: Operating Instructions
4. Lift the dust cover on the unit. 5. 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. - Page 20 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 constant speed regardless of setting.
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Page 21: Power Supplies
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. - Page 22 Connects to FreeStyle unit Figure 13 AirSep’s new universal power supply for the FreeStyle Portable Oxygen Concentrator (POC) is an all- in-one way to keep you fully powered, yet traveling even lighter – wherever you go. The universal power supply (Part Number PW022), described in this insert, enables you to operate your unit while charging its internal battery –...
- Page 23 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 24 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 25 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...
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Page 26: 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 27: 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 28: Alarm/Light Indicators
25% Battery gauge/indicator (Figure 11) light also illuminates intermittently. When this occurs, connect FreeStyle to a DC power outlet or to an AC power outlet, or change to another source of oxygen within two minutes. When FreeStyle is connected to DC power outlet or AC power outlet, the unit operates while recharging FreeStyle’s battery simultaneously. - Page 29 15 minutes. 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 physician may recommend the use of a chin strap if needed.) If the alarm continues to sound, change to another source of oxygen as...
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Page 30: How To Respond To Freestyle's Alarm/Light Indicators
How to Respond to FreeStyle’s Alarm/Light Indicators Status Audible Alarm Light Indicates Action Brief, continuous (Green) pulse; FreeStyle has been You may begin to operate Indicator at start–up continuous light turned on your FreeStyle unit. (Green) pulse; FreeStyle is Continue using FreeStyle... -
Page 31: Cleaning, Care, And Proper Maintenance
Equipment Provider. NOTE 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. -
Page 32: Filter
“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. Use only AirSep Part No. FI144-1 as the air intake filters for this unit. The Manufacturer does not recommend the sterilization of this equipment... -
Page 33: 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 34: 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 35: Materials In Direct Or Indirect Contact With The Patient
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 36: En36
Do not attempt any maintenance other than the possible solutions listed below. NOTE Problem Probable Cause Solution FreeStyle does not operate when a Battery is discharged. Power the unit through the DC outlet, or pulse flow selection button is an AC outlet. - Page 37 Intermittent alarm condition, and the Breathing rate has exceeded the Reduce activity, and then turn unit off and (red) alarm light illuminates capacity of the FreeStyle unit. back on again to reset unit. If necessary, intermittently. change to another source of oxygen as available and contact your Equipment Provider.
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Page 38: Freestyle Specifications
FreeStyle Specifications Oxygen Concentration:* 1-3 pulse settings; equivalent to a continuous flow of 90% 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 39 EMC information provided in this section. 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.
- Page 40 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. IEC 60601 IMMUNITY TEST Electromagnetic environment ±...
- Page 41 FreeStyle The FreeStyle is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the FreeStyle can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the FreeStyle as recommended below, according to the maximum output power of the communications equipment.
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Page 42: 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.