FreeStyle 5™ EN 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.
EN FreeStyle 5™ TABLE OF CONTENTS AirSep® FreeStyle™ 5 Portable Oxygen Concentrator AirSep’s FreeStyle™ 5 Portable Oxygen Concentrator Symbols Why Your Physician Prescribed Oxygen What is the FreeStyle 5 Portable Oxygen Concentrator? Operator Profile FreeStyle 5 for Airline Travel – FAA-Approved Important Safety Rules Important Safety Rules for Optional AirBelt Getting Started with Your FreeStyle 5 Portable Oxygen Concentrator Battery Charging Nasal Cannula FreeStyle 5 Unit Components Operating Instructio
FreeStyle 5™ EN AirSep’s FreeStyle™ 5 Portable Oxygen Concentrator This Patient Manual will acquaint you with AirSep’s FreeStyle™ 5 Portable Oxygen Concentrator (POC). Make sure you read and understand all of the information contained in this manual before you operate your FreeStyle 5 unit. Should you have any questions, your Equipment Provider will be happy to answer them for you.
EN FreeStyle 5™ Consult the accompanying documents Keep unit and accessories dry Use no oil or grease Proper disposal of waste of electrical and electronic equipment required No Smoking Do not disassemble Type BF Equipment RTCA/DO-160 Section 21 Category M Compliant Consult instructions for use This side up Fragile – handle with care Do not expose to open flames FAA – Approved POC RTCA DO160 Section 21 Category M Compliant.
FreeStyle 5™ EN Why Your Physician 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 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.
EN FreeStyle 5™ 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.
FreeStyle 5™ EN ---- [Read the Important Safety Rules section before operating this equipment.] ---- Important Safety Rules Carefully review and familiarize yourself with the following important safety information about the portable FreeStyle 5 Oxygen Concentrator. This device supplies high-concentration oxygen that promotes rapid burning. Do not allow smoking or open flames within the same room of (1) this device, or (2) any oxygen-carrying accessory.
EN FreeStyle 5™ While using the FreeStyle 5 outdoors with the AC power supply, connect the power supply into a Ground Fault Interrupted (GFI) outlet only. Electrical shock hazard. Disconnect the power cord from the electrical outlet before you clean the unit to prevent accidental electrical shock hazard. Only your Equipment Provider or a qualified service technician should remove the covers or service the unit.
FreeStyle 5™ EN In the event of an alarm or you observe that FreeStyle 5 is not working properly; consult the Troubleshooting section in this manual. If you cannot resolve the problem, consult your Equipment Provider. The FreeStyle 5 Portable Oxygen Concentrator may be used during sleep under the recommendation of a qualified clinician.
EN FreeStyle 5™ When the automobile in which you are using the FreeStyle 5 unit is turned off, disconnect and remove the unit from the automobile with you. Do not store FreeStyle 5 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 5. (Refer to the Specifications section in this manual.
FreeStyle 5™ EN Ensure the cannula is fully inserted and secure. This ensures that the FreeStyle 5 unit can properly detect inspiration for oxygen delivery. Storing your FreeStyle 5 for extended periods of time at high temperatures or with a fully charged or completely discharged battery can degrade its overall battery life. Depending upon the temperature of the FreeStyle 5 battery, it can take several minutes for the charging cycle to start after connecting to power.
EN FreeStyle 5™ If the FreeStyle 5 power supply remains connected when the battery is fully charged, the four LEDs will turn off within 2 ½ hours. It may be necessary to initially connect the AC or DC FreeStyle 5 power supply to the FreeStyle 5 unit before the unit will operate for the first time on battery power. Your Equipment Provider may have already performed this step for you. Use only AirSep Part No. FI194-1 for air intake filter for this unit.
FreeStyle 5™ EN 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.
EN FreeStyle 5™ Important Safety Rules for Optional AirBelt 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. Replace safety cap on AirBelt cord when not in use. Do not attempt to charge the optional AirBelt with the FreeStyle 5 power supply, or AirBelt can be damaged. Use only the AirBelt power supply provided to charge AirBelt.
FreeStyle 5™ EN [Read the Important Safety Rules section before operating this equipment.] Getting Started with Your FreeStyle 5 Portable Oxygen Concentrator The FreeStyle 5 packaging contains the following items, as shown in Figures 1-3. If any are missing, contact your Equipment Provider. FreeStyle 5 Portable Oxygen Concentrator with carrying case. Patient manual (not shown) AC power supply (100-240 volts, 50/60 Hz) with power cord.
EN FreeStyle 5™ Figure 2: FreeStyle 5 AC Power Supply/Power Cord Figure 3: FreeStyle 5 DC Power Supply 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 5 AirBelt can cause the battery to get hot, ignite, and may cause serious injury.
FreeStyle 5™ EN All AirBelt Warnings, Cautions and Notes should be read first before proceeding with your equipment. See pg 9, "Important Safety Rules for Optional AirBelt". Other optional accessories include a harness to easily convert the FreeStyle 5 carrying bag to a backpack (part number MI284-1), as shown in Figure 5. The FreeStyle 5 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 5 carrying case. (See Figure 6.
EN FreeStyle 5™ Figure 5: FreeStyle 5 unit worn backpack style Figure 6: FreeStyle 5 unit worn on the waist. Replace safety cap on AirBelt cord when not in use. EN-16 ® AirSep Corporation MN167-1 rev.
FreeStyle 5™ EN Before operating FreeStyle 5 for the first time, familiarize yourself with the major components. These are illustrated in the figures on the following pages and discussed later in the manual. Battery Charging Check to make sure your unit’s battery is fully charged before venturing out with FreeStyle 5 for the first time or upon subsequent use. To check the level of charge of the internal battery, press the BATT button on FreeStyle 5’s keypad.
EN FreeStyle 5™ Optional AirBelt Optionally, you may also have an AirBelt for extended use of FreeStyle 5. The optional AirBelt (Figure 9), can power the FreeStyle 5 unit for up to 7 hours. Before using AirBelt, check that it is sufficiently charged. It requires approximately 3 hours to completely charge. AirBelt is equipped with a battery gauge/indicator to indicate the level of battery charge (25-100%). To check the level of charge, press the button on the AirBelt keypad.
FreeStyle 5™ EN AirBelt Connecting the AirBelt cord to the power supply cord PW009-2 AC/DC Power Supply AirBelt AC/DC Power Supply Figure 9: AirBelt Battery Charging set-up • • • • The FreeStyle 5 AirBelt will completely recharge from its fully depleted state in approximately 3 hours. While charging a fully discharged battery, the LED will continue to blink until 25% capacity is reached. The LED will then turn solid.
EN FreeStyle 5™ ---- [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 5 unit to the user. The tubing is connected to the unit’s oxygen outlet (See Figure 10). Figure 10: Connecting Cannula to FreeStyle 5’s Oxygen Outlet AirSep 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.
FreeStyle 5™ EN Make sure the cannula is fully inserted and secure. This ensures that the FreeStyle 5 unit can properly detect inspiration for oxygen delivery. FreeStyle 5 Unit Components Handle Oxygen Outlet Air Outlet Air Outlet Inlet for Power Connections Air Intake/Filter Cover Figure 11: FreeStyle 5 Exterior View - Front ® AirSep Corporation MN167-1 rev.
EN FreeStyle 5™ Dust Cover Alarm Indicator Pulse Flow Indicator(s) Battery Gauge/ Indicator(s) Flow Selection Button (s) (Internal) Battery Button Figure 12: Close-Up of Keypad/Alarm Display Label/Patient Instructions Figure 13: FreeStyle 5 Exterior View - Back Now that you are familiar with FreeStyle 5’s components, review the instructions on the following pages to operate the Freestyle 5 unit. EN-22 ® AirSep Corporation MN167-1 rev.
FreeStyle 5™ EN [Read the Important Safety Rules section before operating this equipment.] Operating Instructions 1. Locate and position the FreeStyle 5 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.
EN FreeStyle 5™ [Read the Important Safety Rules section before operating this equipment.] Power Supplies FreeStyle 5 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. 2. 3. 4. Internal Battery: A rechargeable internal battery is located within each FreeStyle 5 unit. When it is fully charged, it supplies power to the FreeStyle 5 unit for up to 3 hours.
FreeStyle 5™ EN If the internal battery fully depletes and the FreeStyle 5 unit shuts down, the unit cannot be restarted with the AirBelt. Should this occur, connect your FreeStyle 5 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. Filters Air enters FreeStyle 5 through an air intake filter located under the cover on the lower front of the oxygen concentrator.
EN FreeStyle 5™ Figure 15: Removal of Filter from Filter Cover Do not operate FreeStyle 5 without the air intake filter in place. If a second filter is provided, insert the “replacement” filter before you clean the dirty filter. Use only AirSep Part No. FI194-1 for air intake filter for this unit. EN-26 ® AirSep Corporation MN167-1 rev.
FreeStyle 5™ EN Setting of the Flow Selector The FreeStyle 5 unit has five pulse flow settings: 1, 2, 3, 4, and 5, providing flows equivalent to 1-5 LPM oxygen. Lift the dust cover on the unit’s keypad, and press the 1, 2, 3, 4, or 5 button, which corresponds to the oxygen pulse flow that your physician has prescribed. (See Figures 16 and 17.) Figure 16: Lifting Dust Cover on Keypad Display Figure 17: Pressing Flow Selection Button ® AirSep Corporation MN167-1 rev.
EN FreeStyle 5™ It is very important to select only the prescribed level of oxygen. 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 delivered through the nasal cannula. The green light on the unit’s control panel blinks each time a breath is detected.
FreeStyle 5™ • • • EN FreeStyle 5’s battery simultaneously. The level of battery charge is indicated by the battery gauge/indicator(s). Cannula disconnected When FreeStyle 5 is operating but does not sense breathing, a constant alarm sounds, and the yellow alarm light illuminates after 15 minutes. 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.
EN FreeStyle 5™ How to Respond to FreeStyle 5’s Alarm/Light Indicators Status Audible Alarm Light Indicates Action Indicator Brief, continuous at start–up (Green) pulse; continuous light FreeStyle 5 has been turned on You may begin to operate your FreeStyle 5 unit. Indicator No (Green) pulse; intermittent light FreeStyle 5 is delivering oxygen as a pulse flow. Continue using FreeStyle 5 normally. Indicator No Level indicator Battery charge level. Charge as indicated.
FreeStyle 5™ EN Alarm Rapid intermittent: Beep, beep, beep… (Yellow) alarm; intermittent light Breathing rate is exceeding the capacity of the FreeStyle 5 unit. Reduce activity, then if necessary use another source of oxygen as available. 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.
EN FreeStyle 5™ Cleaning, Care, and Proper Maintenance Cabinet Turn off the FreeStyle 5 unit, and disconnect the power cord from FreeStyle 5 before you clean the cabinet. Do not use liquid directly on the FreeStyle 5 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, concentrated chlorine-based products (ethylene chloride), and oil-based products (Pine-Sol, Lestoil).
FreeStyle 5™ EN Filter Air Intake Filter At least one time each 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. (refer to filter section of this manual) 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.
EN FreeStyle 5™ Part Number / Description PW021-1 AC Power Supply (PW021 cord length 4 ft-6 in / 1.4m) w/ CD023-1 Power Cord 120VAC (8 ft / 2.4m) PW021-2 AC Power Supply w/ CD017-2 Euro Power Cord (8 ft-2 in / 2.5m) PW021-3 AC Power Supply w/ CD025-1 Australian Power Cord 250 VAC (6 ft-6 in / 2.6m) PW021-4 AC Power Supply w/ CD017-4 UK Power Cord (8 ft-2 in / 2.5m) PW024-1 DC Power Supply including power cord adapter (cord length car adapter side 3 ft-5 in / 1m; cord length power supply side 3 ft-1 in / .
FreeStyle 5™ EN Materials in direct or indirect contact with the patient o o o o o o o o o o o o Concentrator casing ...............................Valtra/ABS/Polystyrene Concentrator Control Panel .....................Polyester EBG7 or equivalent Control Panel Door .................................Polycarbonate Concentrator Handle ..............................Polycarbonate Gas Outlet, Nozzle .................................Polycarbonate Air intake filter .........................................
EN FreeStyle 5™ Problem Probable Cause Solution FreeStyle 5 does not operate when a pulse flow selection button is pressed. Battery is discharged. Power the unit through the DC outlet, or an AC outlet. A continuous alarm sounds and the (yellow) alarm light illuminates intermittently. FreeStyle 5 has not detected a breath for 15 minutes. Malfunction. Contact your Equipment Provider, and change to another source of oxygen as necessary. Check the cannula connection.
FreeStyle 5™ EN Problem Probable Cause Solution Rapid intermittent alarm condition, and the (red) alarm light illuminates continuously. A general malfunction has occurred. Change to another source of oxygen as available, and contact your Equipment Provider. Unit does not start on battery power. Unit may be hot or cold if left outdoors such as in an automobile. Allow the unit to reach normal operating temperature, which may take several minutes if exposed to temperature extremes.
EN FreeStyle 5™ FreeStyle 5 Specifications EN-38 Oxygen Concentration:* 1-5 pulse settings; equivalent to a continuous flow of 90% oxygen +5.5 / -3% Pulse Dose: Setting 1: 8.75ml ± 15% Setting 2: 17.5ml ± 10% Setting 3: 26.5ml ± 10% Setting 4: 35.0ml ± 10% Setting 5: 43.75ml ± 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 (.
FreeStyle 5™ EN 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
EN FreeStyle 5™ “Specifications continued” Medical equipment needs special precautions regarding EMC and need to be installed and put into service according to the EMC information provided in this section. Guidance and manufacturer’s declaration ± electromagnetic immunity The FreeStyle 5 is intended for use in the electromagnetic environment specified below. The customer or the user of the FreeStyle 5 should assure that it is used in such an environment.
FreeStyle 5™ EN Guidance and manufacturer’s declaration ± electromagnetic immunity The FreeStyle 5 is intended for use in the electromagnetic environment specified below. The customer or the user of the FreeStyle 5 should assure that it is used in such an electromagnetic environment. IMMUNITY test IEC 60601 TEST LEVEL Compliance level Conducted RF IEC 61000-4-6 3 Vrms 150 kHz to 80 MHz 3 Vrms Radiated RF IEC 61000-4-3 3 V/m 80 MHz to 2.
EN FreeStyle 5™ Recommended separation distances between portable and mobile RF communications equipment and the FreeStyle 5 The FreeStyle 5 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
FreeStyle 5™ EN Classification 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). 3) Not intended for direct cardiac application.
EN FreeStyle 5™ Limited Warranty AirSep Corporation warrants the FreeStyle 5 Oxygen Concentrator to be free from defect in parts for three years (as specified on the original invoice provided) from the date of delivery to the original purchaser, under normal use and operation. The battery is warranted for one year.
