FreeStyle™ Portable Oxygen Concentrator
Contents
1. Contraindications for Use In certain circumstances the use of non prescribed oxygen can be hazardous This device should only be used when prescribed by a physician NOT FOR USE IN THE PRESENCE OF FLAMMABLE ANETHETICS WARNING As with any electrically powered device the user may experience periods of non operation as a results of electrical power interruption or the need to have the oxygen concentrator serviced by a qualified technician The oxygen concentrator is not appropriate for any patient who would experience adverse health consequences as the result of such temporary interruption 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 WARNING inspection or possible repair of the device Do not use the oxygen concentrator if it has a damaged power cord or plug Cet appareil produit de l oxygene a concentration lev e favorisant une combustion rapide Ne pas permettre de fumer ou des flammes nues dans la m me chambre 1 cet appareil ou 2 tout accessoire contenant de l oxygene Ne pas utiliser de produits a base d huile de graisse ou de p trole sur ou a proximit de l unite D connecter le cordon d alimentation de la prise lectrique avant de nettoyer ou de faire l entretien de l unit WARNING Risque de choc lectri2. Patient Manual FreeStyle Portable Oxygen Concentrator 260 Creekside Drive Buffalo NY 14228 2085 USA WARNING DO NOT OPERATE THIS EOUIPMENT 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 COULD OCCUR 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 the oxygen carrying accessories WARNING Smoking while wearing an oxygen cannula can cause facial burns and possibly result in death Removing the cannula and placing it clothing bedding sofas or other cushion material will cause a flash fire when exposed to a cigarette heat source spark or open flame If you smoke you must always follow these 3 important steps first 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 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 Federal USA law restricts this device to sale or rental by order of a physician or other licensed health care provider CAUTION
3. Battery cycle life Audible alarms and pulse visual indicators Sound Temperature range Max Operational Altitude 1 3 pulse settings equivalent to a continuous flow of 90 oxygen 5 5 3 Flow Rate Settings 1 2 amp 3 LPM equivalent to continuous flow Settings 1 through 3 10 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 4 4 lb 2 0 kg 1 8 Ib 8 kg optional AirBelt Universal AC DC Power Supply 100 240VAC 1 75A Max 50 60Hz 11 16VDC 8 0A Max 3 LPM 2 hours 2 LPM 2 5 hours 1 LPM 3 5 hours Optional AirBelt when combined with the internal battery 3 LPM 5 hours 2 LPM 6 hours 1 LPM 10 hours 3 5 hours optional AirBelt 3 hours 2 minutes Approximately 300 cycles then 80 capacity or below Start up audible and visual GREEN indicator light Pulse flow visual GREEN light Battery condition battery level GREEN indicator lights Cannula disconnect audible and visual RED alarm light System overdraw audible and visual RED warning and alarm lights High and low pressure audible and visual RED alarm light Service required visual YELLOW alarm light 38 dBA at setting 41 dBA at 2 setting 44 dBA at 3 setting 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 up to 12 000 ft 3 657 6 m 483mmHg Higher alti
4. Do not attempt any maintenance other than the possible solutions listed below FreeStyle does not operate when a pulse flow Battery is discharged Power the unit through the DC outlet or an AC selection button is pressed outlet Malfunction Contact your Equipment Provider and change to another source of oxygen as necessary A continuous alarm sounds and the red alarm FreeStyle has not detected a breath for 15 Check the cannula connection light illuminates continuously minutes Ensure that cannula tubing is not kinked Make sure that the cannula is positioned properly and that you are breathing through your nose For mouth breathing your clinician may recommend a chin strap Intermittent alarm condition and the yellow Battery requires charging Connect to a DC or an AC outlet within 2 minutes BATT light illuminates intermittently or connect to the optional AirBelt MN123 1 rev F 34 Rapid alarm condition and the yellow BATT light illuminates intermittently and FreeStyle shuts down Intermittent alarm condition and the red alarm light illuminates intermittently Intermittent alarm condition and the red alarm light illuminates continuously Unit does not start on battery power Delay in recharging internal battery Unit alarms while in automobile and connected to the DC outlet All other problems MN123 1 rev F Battery voltage is too low to operate the FreeStyle unit Breathing
5. NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people 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 Emissions test Compliance Electromagnetic Environment guidance The FreeStyle uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions CISPR 11 Group 1 The Freestyle is suitable for use in all establishments including domestic establishments and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes RF emissions CISPR 11 Class B Harmonic emissions IEC 61000 3 2 Class A Voltage fluctuations flicker emissions Complies IEC 61000 3 3 MN123 1 rev F 39 Classification Type of protection against electric shock Class Il 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 in
6. Red alarm continuous light FreeStyle has been turned on Freestyle is delivering oxygen as a pulse flow Battery charge level Service required No breath detected by the unit for a predetermined time period Battery voltage is too low to operate FreeStyle Breathing rate is exceeding the capacity of the FreeStyle unit General malfunction of the FreeStyle unit has occurred You may begin to operate your FreeStyle unit Continue using FreeStyle normally Charge as indicated 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 Connect the FreeStyle unit into a DC outlet or an AC outlet immediately Reduce activity then if necessary use another source of oxygen as available Contact your Equipment Provider Turn off the unit Change to another source of oxygen and contact your 28 Cleaning Care and Proper Maintenance Cabinet Electrical shock hazard Turn OFF the unit and disconnect the power cord from the electrical outlet before you clean the unit to prevent accidental electrical shock and burn hazard Only your Equipment Provider or a qualified service technician should remove the covers or service the unit Care should be taken to prevent the Oxygen Concentrator and the battery from getting wet or allowing fluids to enter WARNING the unit
7. 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 MN123 1 rev F 24 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 See Figures 23 and 24 Figure 23 Lifting Dust Cover on Keypad Display Figure 24 Pressing Flow Selection Button 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 unless you have CAUTION been directed to do so by a licensed clinician The portable Oxygen Concentrator may be used during sleep under the recommendation of a qualified clinician MN123 1 rev F 25 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 interm
8. 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 Symbols 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 Portable Oxygen Concentrator Symbo Symbo 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 Complies with the 93 42 EEC unsafe practice that can result in directive drawn up by the approved minor bodily injury or property organization No 0459 damage Class II Equipment double insulated Note Provides information important enough to emphasize or See Instructions repeat Consult the accompanying Keep unit and accessories dry documents Use no oil or grease Proper disposal of waste of electrical and electronic equipment required MN123 1 rev F 1 RTCA DO160 Section 21 Category i Safety agency for CAN C
9. gt 95 dipin Ur for 0 5 cycle 40 Ur 60 dipin Ur for 5 cycles 70 Ur 30 dipin Ur for 25 cycles lt 5 Ur gt 95 dipin Ur for5s NOTE U is the a c mains voltage prior to application of the test level MN123 1 rev F Electromagnetic environment guidance Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment If the user of the FreeStyle requires continued operation during power mains interruptions it is recommended that the FreeStyle be powered from an uninterruptible power supply UPS or a battery Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment 37 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 TEST Compliance f F 3 Portable and mobile RF communications equipment should be used no closer Conducted RF 3 Vrms to any part of the FreeStyle including
10. Additional supplies are available from your Equipment Provider MN123 1 rev F 15 FreeStyle Unit Components Handle Oxygen Outlet Air Outlet Figure 10 FreeStyle Exterior View Front Air Outlet Dust Cover Alarm Service Indicator Pulse Flow Indicator s Battery Gauge Flow Selection Button Indicator s Internal Battery Button Figure 11 Close Up of Keypad Alarm Display Inlet for Power Connections Air Intake Filter Cover RTCA DO160 indicates that FreeStyle unit has been tested and approved to Label Patient comply with FAA Instructions 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 MN123 1 rev F 16 Read the Important Safety Rules section before operating this equipment Operating Instructions I 2 Locate and position the FreeStyle so that the air inlets and air outlets are not obstructed Power the unit from a the internal battery b AirBelt c DC outlet 1 e automobile or motor boat or d an AC outlet 1 e normal household electric Refer to the Power Supplies section of this Patient Manual 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 gre
11. English A multilingual version of the manual is available through your Equipment Provider Espanol Una version multiling e del manual esta disponible a traves de su proveedor de equipo Francais Une version multilingue du manuel est disponible par l interm diaire de votre fournisseur de materiel Deutsche Eine mehrsprachige Version des Handbuchs ist in Ihrer Gerate Anbieter TABLE OF CONTENTS AirSep FreeStyle Portable Oxygen Concentrator AirSep s FreeStyle Portable Oxygen Concentrator 1 Symbols 1 2 Why Your Physician Prescribed Oxygen 2 What is the FreeStyle Portable Oxygen Concentrator 3 Operator Profile 3 FreeStyle for Airline Travel FAA Approved 4 Important Safety Rules 5 10 Getting Started with Your FreeStyle Portable Oxygen Concentrator 11 12 Battery Charging 13 14 Nasal Cannula 15 FreeStyle Unit Components 16 Operating Instructions 17 18 Power Supplies 19 23 Filters 24 Setting of the Flow Selector 25 TABLE OF CONTENTS AirSep FreeStyle Portable Oxygen Concentrator Alarm Light Indicators How to Respond to FreeStyle s Alarm Light Indicators Cleaning Care and Proper Maintenance Cabinet Filter Carrying Bag Alarm Service Indicator FreeStyle Accessories Materials in direct or indirect contact with the patient Reserve Oxygen Supply Troubleshooting FreeStyle Specifications Classification 26 27 28 29 29 30 31 31 32 33 33 33 35 36 39 40 AirSep
12. causing property damage bodily injuries or death Do not leave a nasal cannula on clothing bed coverings or chair cushions If the unit is turned on but not in use the oxygen will make the material flammable Set the I O power switch to the 0 Off position when the Oxygen Concentrator is not in use Use no oil grease or petroleum based or other flammable products with the oxygen carrying accessories or the Oxygen Concentrator Only water based oxygen compatible lotions or salves should be used Oxygen accelerates the combustion of flammable substances This unit is not to be used for life support Geriatric pediatric or any other patient unable to communicate discomfort while using this device may require additional monitoring Patients with hearing and or sight impairment s may need assistance with monitoring alarms Pulse Dose Node settings must be determined for each patient individually for their needs at rest during exercise and when traveling If you feel discomfort or are experiencing a medical emergency seek medical assistance immediately Electrical shock hazard Turn OFF the unit and disconnect the power cord from the electrical outlet before you clean the unit to prevent accidental electrical shock and burn hazard Only your Equipment Provider or a qualified service technician should remove the covers or service the unit Care should be taken to prevent the Oxygen Concentrator and the battery from getting wet or allowing
13. power to the Oxygen Concentrator MN123 1 rev F 7 CAUTION When the automobile in which you are using the Oxygen Concentrator unit is turned off disconnect and remove the device from the automobile Do not store the Oxygen Concentrator in a very hot or cold automobile or in other similar high or low temperature environments DO NOT leave the Oxygen Concentrator or the Power Supply plugged into the vehicle if the ignition is in the OFF position Doing so may drain the vehicle s battery 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 unless you have been directed to do so by a licensed clinician The portable Oxygen Concentrator may be used during sleep under the recommendation of a qualified clinician If the Oxygen Concentrator has been stored for an extended period of time outside its normal operating temperature range the unit should be allowed to return to normal operating temperature before being turned on Refer to the Specifications section in this manual Operating or storing the Oxygen Concentrator outside of its normal operating temperature range can affect performance and decrease battery run time and or increase battery charge time Refer to t
14. saturate the bag then allow to air dry Do not machine wash or dry the bag Dual display Service Required yellow Alarm Condition red 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 This feature is not available in all models MN123 1 rev F 31 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 includes CD034 1 PW022 1 2 3 or 4 BT017 1 2 3 or 4 MI240 2 MIO78 1 MI284 1 FI144 1 MI320 1 MI283 1 MI304 1 PW022 1 PW022 2 PW022 3 PW022 4 BTO17 1 BTO17 2 BTO17 3 BTO17 4 MN123 1 rev F Freestyles Bag Set includes the following Carry All Accessory Bag Carrying Bag FreeStyle Shoulder Strap FreeStyle This is part of the MI283 1 DC power cord 33in 860mm Universal AC DC Power Supply with battery charger including the following power cords as applicable Universal AC DC Power Supply 4ft 1 2m w CD023 2 Power Cord 12
15. the most cost effective efficient and safest alternative to using high pressure 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 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 This eliminates the waste associated with a continuous flow oxygen device that flows oxygen while you are exhaling 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 FreeStyle operates from four different power sources Refer to the Power Supplies section of this manual Operator Profile AirSep s Concentrators are intended to supply supplemental Oxygen to users suffering from discomfort due to ailments which
16. to another source of oxygen as available and contact your Equipment Provider o General malfunction If FreeStyle has a general malfunction a rapid alarm sounds every 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 This unit is not to be used for life support Geriatric pediatric or any other patient unable to communicate discomfort while using this device may require additional monitoring Patients with hearing and or sight impairment s may need assistance with monitoring alarms WARNING Pulse Dose Node settings must be determined for each patient individually for their needs at rest during exercise and when traveling If you feel discomfort or are experiencing a medical emergency seek medical assistance immediately MN123 1 rev F 27 How to Respond to FreeStyle s Alarm Light Indicators Brief continuous at start up Indicator Indicator Continuous Alarm Beep Intermittent Beep beep beep Rapid intermittent Beep beep beep Rapid intermittent Beep beep beep MN123 1 rev F Green pulse sei heed Green pulse intermittent light Level indicator Yellow continuous light Red alarm continuous light 20 Yellow BATT battery indicator Red alarm intermittent light
17. 0V 8ft 2 4m and CD034 1DC power cord 33in 860mm Universal AC DC Power Supply 4ft 1 2m w CDO17 2 Euro Power Cord 8 ft 2 in 2 5m and CD034 1DC power cord 33in 860mm Universal AC DC Power Supply 4ft 1 2m w CD025 1 Australian Power Cord 250 VAC 6 ft 6 in 2 6m and CD034 1 DC power cord 33in 860mm Universal AC DC Power Supply 4ft 1 2m w CD017 4 UK Power Cord 8 ft 2 in 2 5m and CD034 1 DC power cord 33in 860mm Optional AirBelt includes the following AirBelt with Power Supply including the following power cords as applicable AirBelt with Power Supply PWOO8 1 BTO17 extended cord length 4 ft 1 2m w CD023 2 Power Cord 120VAC 8 ft 2 4m AirBelt with Power Supply PWO08 2 BTO17 extended cord length 4 ft 1 2m w CDO17 2 Euro Power Cord 8 ft 2 in 2 5m AirBelt with Power Supply PW008 3 BT017 extended cord length 4 ft 1 2m w CD025 1 Australian Power Cord 250 VAC 6 ft 6 in 2 6m AirBelt with Power Supply PW008 4 BTO17 extended cord length 4 ft 1 2m w CD017 4 UK Power Cord 8 ft 2 in 2 5m Additional or Other Options AirBelt Extender AirBelt Extender New Velcro Version Shoulder Harness option enables converting the supplied FreeStyle carrying bag to a backpack Air Intake Filter 32 No modification of this equipment is permitted Use of cables and adapters other than those specified with the exception of cables and adapters sold by the manufacturer of the medical electr
18. SA C22 2 Pe ae kiad raaraa M Compliant FAA SFAR 106 3 No 60601 1 08 M90 for medical aid P requirement a electrical equipment SID C222 No 60601 1408 This side up j No 601 1 M90 for medical electrical equipment mar Safety agency for CAN CSA C22 2 Fragile handle with care FAA Approved POC i EC REP CT REP Authorized Representative in the Saal Number European Community Eu Catalog number T Date of Manufacture 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 Your physician prescribed a flow or setting to address your particular respiratory condition Although Oxygen is a non addictive drug unauthorized 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 MN123 1 rev F 2 What is the FreeStyle Portable Oxygen Concentrator Oxygen concentrators were introduced in the mid 1970 s and has become the most convenient reliable source of supplemental oxygen available today Oxygen concentrators are
19. Sep 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 PWO22 described in this insert enables you to operate your unit while charging its internal battery all from one component whether you are driving to the grocery market taking a vacation flight or simply relaxing at a friend s home This universal power supply replaces the two separate AC and DC power supplies that were previously packaged with the FreeStyle unit and covered in your patient manual Your power supply kit is packed complete with three essential accessories as follows e universal power supply PWO17 1 which operates on AC power from 120 240 volts and with multiple DC power sources including automobile and airplane power e removable AC power cord CD023 2 UsS style CD017 2 Euro style depending on usage location CD025 1 Australian style or CD017 4 UK style e removable DC power cord which incorporates both the connector for automobile type outlets and the D shaped 4 pin connector for EmPower type outlets commonly used on airlines CD034 1 Note FreeStyle s internal battery will completely recharge from its fully depleted state in approximately 3 hours whether the unit is in use on AC or DC power MN123 1 rev F 20 Start with the Universal AC DC Power Supply and FreeStyle Connection Fo
20. This can cause a malfunction or shut down and cause an increased risk for electrical shock or burns 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 These are NOT to be used to clean the plastic housing on Oxygen Concentrator as they can damage the units plastic Clean the cabinet control panel and power cord only with a mild household cleaner applied with a damp not wet cloth or sponge and then wipe all surfaces dry Do not allow any liquid to get inside the device Pay special attention to the oxygen outlet for the cannula connection to make sure it remains free of dust water and particles While using the portable Oxygen Concentrator outdoors with the AC power supply connect the power supply into a Ground Fault Interrupted GFI outlet only Always disconnect AC Power Supply from the wall before disconnecting the AC Power Supply from the oxygen concentrator Always follow the cannula manufacturer s instructions for proper use Replace the disposable cannula as recommended by the cannula manufacturer or your Equipment Provider Additional supplies are available from your Equipment Provider Keep the FreeStyle unit clean and free from moisture and dust Clean the plastic housing periodically by wiping with a lint free c
21. acturer or your Equipment Provider Additional supplies are available from your Equipment Provider MN123 1 rev F 18 Power Supplies FreeStyle can be powered in four different ways the internal battery a Universal AC DC power supply and an optional AirBelt battery belt in combination with the unit s internal battery l 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 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 Universal AC DC power supply and a 100 240 volt 50 60 Hz AC power outlet or connect it to a DC power outlet in an automobile boat motor home etc A discharged battery requires approximately 3 hours to fully charge It is recommended to recharge the battery even if only partially depleted as often as possible Universal AC DC Power Supply A Universal AC DC 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 Universal AC DC power supply power from the AC outlet powers the unit and recharges FreeStyle s battery simultaneously Optional AirBelt External Battery Belt Fre
22. cables than the recommended separation IEC 61000 4 6 150 kHz to 80 MHz ng from the equation applicable to the frequency of the Recommended separation distance Radiated RF 3 V m D 1 2 x VP IEC 61000 4 3 80 MHZ to 2 5 GHz D 1 2 x VP from 80MHz to 800MHz D 2 3 x VP from 800MHz to 2 5GHz where Pis the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in metres m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people a Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the FreeStyle is used exceeds the applicable RF compliance level above the FreeStyle sh
23. cial airlines via a 2006 amendment to SFAR 106 In addition as of May 13 2009 a new Department of Transporation DOT FAA ruling has determined that US based carriers as well as international flights with origination or destination in the US must allow passengers with FAA approved portable oxygen concentrators to use them on board and in flight as medically necessary Check directly with the individual airlines with which you would like to travel for up to date information on their specific POC policies MN123 1 rev F 4 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 Oxygen Concentrator WARNING WARNING WARNING MN123 1 rev F 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 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 Failure to observe this warning can result in severe fire property damage and or cause physical injury or death Do not use your oxygen concentrator in the presence of flammable gases This can result in rapid burning
24. eStyle 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 AC power supply When using the AirBelt with a fully charged internal battery the FreeStyle s internal battery will deplete before the AirBelt The AirBelt must be connected to the FreeStyle unit before the FreeStyle s internal battery is depleted Observe and connect the AirBelt to the FreeStyle unit before its internal battery discharges to 25 or less For oxygen concentrators equipped with batteries 1 When connected to AC or DC power the unit s battery charges until it reaches full capacity either while the unit is operating or turned off If the internal battery fully depletes and the Oxygen Concentrator shuts down the unit cannot be restarted with the optional AirBelt Should this occur connect your Oxygen Concentrator 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 MN123 1 rev F 19 FreeStyle Universal AC DC Power Supply Instructions for use GI Connections for removable AC or DC power cord az Connects to FreeStyle unit Figure 13 Air
25. 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 Oxygen Concentrator use requires a physician s prescription and is not intended for life support use Although Oxygen therapy can be prescribed for patients of all ages the typical oxygen therapy patient is older than 65 years of age and suffers from Chronic Obstructive Pulmonary Disorder COPD Patients typically have good cognitive abilities and must be able to communicate discomfort If the user is unable to communicate discomfort or unable to read and understand the concentrator labeling and instructions for use then use is recommended only under the supervision of one who can If any discomfort is felt while using the concentrator patients are advised to contact their healthcare provider Patients are also advised to have back up oxygen available i e cylinder oxygen in the event of a power outage or concentrator failure There are no other unique skills or user abilities required for concentrator use MN123 1 rev F 3 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 commer
26. en 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 To change the pulse flow setting press the appropriate button After the automatic start up mode it is normal to hear a difference in sound as you change the settings 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 time required to reach maximum oxygen concentration after turning on the FreeStyle unit is approximately two minutes 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 Failure to observe this warning can result in severe fire property damage and or cause physical injury or death WARNING Do not use your oxygen concentrator in the presence of flammable gases This can result in rapid burning causing property damage bodily injuries or death Do not leave a nasal cannula on clothing bed coverings or chair cushions If the unit is turned on but not in use the oxygen will make the material flammable Set the I O power switch to the O Off position when the Oxygen Concentrator is not in use Use no oil grease or petroleum based or other flammable products with the oxygen carrying access
27. fluids to enter the unit This can cause a malfunction or shut down and cause an increased risk for electrical shock or burns WARNING WARNING WARNING WARNING MN123 1 rev F 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 These are NOT to be used to clean the plastic housing on Oxygen Concentrator as they can damage the unit s plastic Clean the cabinet control panel and power cord only with a mild household cleaner applied with a damp not wet cloth or sponge and then wipe all surfaces dry Do not allow any liquid to get inside the device Pay special attention to the oxygen outlet for the cannula connection to make sure it remains free of dust water and particles While using the portable Oxygen Concentrator outdoors with the AC power supply connect the power supply into a Ground Fault Interrupted GFI outlet only Always disconnect AC Power Supply from the wall before disconnecting the AC Power Supply from the oxygen concentrator The Oxygen Concentrator should not be used adjacent to or stacked with other equipment If adjacent or stacked use is unavoidable the device should be observed to verify normal operation No modification of this equipment is permitted Use of cables and adapters other than t
28. he Specifications section in this manual for storage and operating temperature limits For oxygen concentrators equipped with batteries Store in a cool and dry location to help ensure the longevity of your battery Storing your Oxygen Concentrator for extended periods of time at high temperatures or with a fully charged or completely discharged battery can degrade its overall battery life Do not attempt to open the battery there are no serviceable parts inside the battery Keep batteries away from children ONLY USE the Manufacturer s provided batteries For proper battery disposal contact your Equipment Provider or your local government agency for disposal requirements In the event of an alarm or you observe the Oxygen Concentrator is not working properly consult the Troubleshooting section in this manual If you cannot resolve the problem consult your Equipment Provider Do not attempt any maintenance other than the possible solutions listed within this manual DO NOT remove covers only your Equipment Provider or a qualified service technician should remove the covers or service this device The US Department of Transportation DOT and United Nations UN Regulations require the removal of the battery from the device for all international airline travel wnen the oxygen concentrator is checked as luggage When shipping the oxygen concentrator the battery must also be removed from the device and packaged properly MN123 1 rev F g Ens
29. hose specified with the exception of cables and adapters sold by the manufacturer of the medical electrical equipment as replacement parts for internal components may result in increased emissions of decreased immunity of the Oxygen Concentrator Use only electrical voltage specified on the specification label affixed to the device Do not use extension cords with this unit or connect too many plugs into the same electrical outlet The use of extension cords could adversely affect the performance of the device Too many plugs into one outlet can result in an overload to the electrical panel causing the breaker fuse to activate or fire if the breaker or fuse fails to operate Operating outside of the operational specifications can limit the concentrator s ability to meet Oxygen Concentration specification Refer to the specifications section of this manual for storage and operating temperature limits The incorrect use of the battery can cause the battery to get hot ignite and may cause serious injury Be sure not to pierce strike step on drop the battery or otherwise subject the battery to strong impacts or shocks The use of a damaged battery may cause personal injury DO NOT expose the battery to fire or dispose of in a fire This may cause the battery to explode and cause potential injury DO NOT short circuit the battery s metal contacts with metallic objects such as keys or coins This may cause sparks or excessive heat to be generated
30. ical equipment as replacement parts for internal components may result in increased emissions of VARNING decreased immunity of the Oxygen Concentrator Materials in direct or indirect contact with the patient O Concentrator Casing s sesessesesses Valtra ABS Polystyrene o Concentrator Control Panel Polyester EBG7 or equivalent O Control Panel Doof ass ee Polycarbonate o Concentrator Handle Polycarbonate Gas Outlet Nozzle race Polycarbonate Misael rennen essen Lexan ZEOIL CONS ee ee Polyurethane Cord CONNECIOLS rei Polycarbonate V inyl chloride POWER CO ende PVC Metal POWet SUPPLY use Lexan 940 Polycarbonate O Battery Packen senden Lexan 945 o Battery Pack Power Supply Labels Polyester film o Concentrator carrying case 100 Polyester microfiber w PCV backing o Battery carrying case Belt and Strap 100 Polyester microfiber w PVC backing Reserve Oxygen Supply Your Equipment Provider may recommend another source of supplemental oxygen therapy in case there is a mechanical failure or a power outage 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 MN123 1 rev F 33
31. ied for use with this oxygen concentrator may impair its performance Recommended accessories are referenced within this manual To Equipment Provider The following oxygen administration accessories are recommended for use with the Oxygen Concentrator e Nasal Cannula with 7 feet 2 1 m of tubing Part No CU002 1 e Use only the manufacturer s replacement air intake filter Part No Fl144 1 e OxySafe Kit Part No 20629671 Do not operate the Oxygen Concentrator without the air intake filter in place If a second filter is provided insert the 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 The Manufacturer does not recommend the sterilization of this equipment To prevent a void warranty follow all manufacturers instructions Portable and mobile RF communications equipment can effect medical electrical equipment There is never a danger of depleting the oxygen in a room when you use your Oxygen Concentrator unit MN123 1 rev F 9 concentrator For customers in regions requiring compliance to EN ISO 8359 1996 Ammendment1 2012 this accessory will meet this need VI AirSep offers the OxySafe as an optional accessory This is intended to be used in conjunction with the FreeStyle The OxySafe is a thermal fuse to stop the flow of gas in the event that the downstream cannula or oxygen tubing is ignited and burns to the OxySafe It is
32. 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 Read the Important Safety Rules section before operating this equipment MN123 1 rev F 13 Charging of the battery may take several minutes after connecting the power to initiate depending on the battery s internal operating temperature This is anormal condition and is intended for safe battery charging This circumstance is more likely when the battery has been fully discharged If the device power supply remains connected when the battery is fully charged the four LEDs will turn off within approximately 1 hour For oxygen concentrators equipped with batteries The Oxygen Concentrator battery does not need to be fully discharged before recharging It is recommended to charge the Oxygen Concentrator battery after each use 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 35 F 23 C 2 C e The FreeStyle s internal battery will completely recharge from its fully depleted state in approximately 3 hours whether or not the unit is in use on Universal AC DC power e While charging a fully discharged battery initially the 25 LED will start blinking rapidly fo
33. ittently each time a breath is detected Additionally when the unit is operating on and simultaneously being charged through the Universal AC 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 summarized on the chart later in this section of the manual This unit is not to be used for life support Geriatric pediatric or any other patient unable to communicate discomfort while using this device may require additional monitoring Patients with hearing and or sight impairment s may need assistance with monitoring alarms WARNING Pulse Dose Node settings must be determined for each patient individually for their needs at rest during exercise and when traveling If you feel discomfort or are experiencing a medical emergency seek medical assistance immediately 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 o Start Up A brief alarm sounds at start up FreeStyle begins to operate when the alarm stops o Low Battery As the battery power approaches a low le
34. life support Geriatric pediatric or any other patient unable to communicate discomfort while using this device may require additional monitoring Patients with hearing and or sight impairment s may need assistance with monitoring alarms Pulse Dose Node settings must be determined for each patient individually for their needs at rest during exercise and when traveling If you feel discomfort or are experiencing a medical emergency seek medical assistance immediately It may be necessary to initially connect the Universal AC DC FreeStyle power supply to the FreeStyle unit before the unit will operate for the first time on battery power 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 After this period it is normal to hear a change in speed at the 1 and 2 settings This variation in sound represents the differences in oxygen production the unit makes at each setting Ensure the cannula is fully inserted and secure This ensures that the Oxygen Concentrator can properly detect inspiration for oxygen delivery During inhalation you should hear or feel oxygen flow to the prongs of the nasal cannula Always follow the cannula manufacturer s instructions for proper use Replace the disposable cannula as recommended by the cannula manuf
35. lluminate and requires resetting disconnect the power supply from the motor vehicle s DC outlet restart your vehicle and then reconnect your power supply into the DC outlet 1 Make sure your power supply is securely connected to the FreeStyle inlet as shown in Figure 14 2 Connect the proper DC power cord end to the inlet marked ACCESSORY DC IN on the power supply as shown in Figure 17 3 Turn on your motor vehicle 4 Connect the DC power cord to the motor vehicle s DC outlet as shown in Figure 18 t 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 Figure 17 Figure 18 Use with AirLine Power at Passenger seat with 4 pin connection configuration AirSep s FAA approved FreeStyle enables you to use this POC in flight on most commercial airlines around the world Each airline establishes its own policy for FAA approved POC use as well as the requirements for and the availability of optionally allowing you to power your unit onboard the aircraft Aircraft equipped passenger power may include one or more of the following sources an AC power outlet a DC power outlet similar to that typically found in an automobile or a DC power outlet with a 4 pin configuration If the specific airline on which you are traveling allows you to connect your POC unit at a seat equi
36. loth 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 To prevent a voided AirSep warranty follow all manufacturer s instructions MN123 1 rev F 29 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 1s 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 the Oxygen Concentrator without the air intake filter in place If a second filter is provided insert the 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 MN123 1 rev F 30 Carrying Bag To clean the carrying bag and strap brush only with warm soapy water do not
37. ories 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 See Figure 6 The optional accessories bag part number MI320 1 enables even more convenient travel when transporting all power accessories and optional AirBelts and or the harness for use at your intended destination Figure 4 AirBelt and Universal AC DC Power Supply Power Cord Figure 5 FreeStyle unit worn backpack style Figure 6 FreeStyle unit worn on the waist Replace safety cap on AirBelt cord when not in use WARNING Before operating FreeStyle 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 Read the Important Safety Rules section before operating this equipment MN123 1 rev F 12 Battery Charging Check to make sure your unit s battery s 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 Note The internal battery is charging whenever the unit is operating on AC o
38. ories or the Oxygen Concentrator Only water based oxygen compatible lotions or salves should be used Oxygen accelerates the combustion of flammable substances See additional warnings on page 18 of this manual MN123 1 rev F 17 Operating outside of the operational specifications can limit the concentrator s ability to meet Oxygen Concentration specification Refer to the specifications section of this manual for storage and operating temperature limits WARNING The Oxygen Concentrator should not be used adjacent to or stacked with other equipment If adjacent or stacked use is unavoidable the device should be observed to verify normal operation No modification of this equipment is permitted Use of cables and adapters other than those specified with the exception of cables and adapters sold by the manufacturer of the medical electrical equipment as replacement parts for internal components may result in increased emissions of decreased immunity of the Oxygen Concentrator Use only electrical voltage specified on the specification label affixed to the device Do not use extension cords with this unit or connect too many plugs into the same electrical outlet The use of extension cords could adversely affect the performance of the device Too many plugs into one outlet can result in an overload to the electrical panel causing the breaker fuse to activate or fire if the breaker or fuse fails to operate This unit is not to be used for
39. ould be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as re orienting or relocating the FreeStyle b Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m MN123 1 rev F 38 Recommended separation distances between portable and mobile RF communications equipment and the 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 Separation distance according to frequency of transmitter Rated maximum output m power of transmitter from 150kHz to SOMHz from 80MHz to 800MHz from 800MHz to 2 5GHz ue d 1 2 x P d 1 2 x VP d 2 3 x P 0 23 0 73 ZO 13 23 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in Watts W according to the transmitter manufacturer NOTE 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies
40. placed in line with the nasal cannula or oxygen tubing between the patient and the oxygen outlet of the Visionaire For proper use ofthe OxySafe always refer to the manufacturer s instructions included with each OxySafe kit AirSep offers an OxySafe kit that includes OxySafe with 2 of tubing to connect to the oxygen outlet PN 20629671 Important Safety Rules for Optional AirBelt For oxygen concentrators equipped with the optional Airbelt 1 WARNING 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 For oxygen concentrators equipped with batteries When connected to AC or DC power the unit s battery charges until it reaches full capacity either while the unit is operating or turned off If the internal battery fully depletes and the Oxygen Concentrator shuts down the unit cannot be restarted with the optional AirBelt Should this occur connect your Oxygen Concentrator 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 For oxygen concentrators equipped with the optional Airbelt 1 The AirBelt does not need to be fully discharged before recharging It i
41. pped with a 4 pin DC power configuration take the following steps MN123 1 rev F 22 Make sure your power supply is securely connected to the FreeStyle inlet as shown in Figure 14 Connect the proper DC power cord end to the ACCESSORY DC IN inlet on the power supply as shown in Figure 19 Remove the tip of the DC connector by pressing on the tab to expose the 4 pin connector as shown in Figure 20 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 VR WN Figure 19 Figure 20 For more information on the universal power supply for FreeStyle or any AirSep product accessories please contact your local equipment provider MN123 1 rev F 23 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 Figure 21 Removal of Air Intake Figure 22 Removal of Filter from Filter Cover Filter Cover Do not operate the Oxygen Concentrator without the air intake filter in place If a second filter is provided insert the
42. que Ne pas enlever les couvercles lorsque l unit est branch e Seuls votre fournisseur d quipement ou un technicien de service qualifi devrait enlever les couvercles ou faire l entretien de l unite Federal USA law restricts this device to sale or rental by order of a physician or other licensed health care provider Do not position the Concentrator so that it is difficult to access the power cord The concentrator should be located as to avoid smoke pollutants or fumes Always place oxygen supply tubing and power cords in a manner that prevents a trip hazard Do not operate unit in a restricted or confined space i e a small case or handbag where ventilation can be limited This can cause the Oxygen Concentrator to overheat and impair performance Do not allow either the air intake or the air outlet vents to become blocked DO NOT drop or insert any objects into any openings on the device This can cause the Oxygen Concentrator to overheat and impair performance When using the Oxygen Concentrator in an automobile boat or on other DC sources with the DC power supply make sure that the vehicle is started and running before connecting the Oxygen Concentrator If the DC power supply does not illuminate and requires resetting disconnect the DC power supply from the DC outlet restart your vehicle and then reconnect your DC power supply into the DC outlet Failure to follow these instructions can result in the power supply not supplying
43. r DC power To charge FreeStyle s internal battery simply connect its Universal AC DC power supply into the unit s power connection inlet as shown in Figure 7 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 s inlet connection These must be properly aligned and when removing the power cord the release button must be pressed to remove it from the FreeStyle unit This ensures that neither the unit nor the power accessories are damaged Press to remove FreeStyle unit s power cord Power Inlet m The optional AirBelt which can increase FreeStyle s total battery duration 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 8 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 Optional AirBelt For oxygen concentrators equipped with the optional Airbelt 3 The AirBelt does not need to be fully discharged before recharging It is recommended to charge it after each use NOTE 4 Depending upon the temperature of the AirBelt
44. r a few minutes then start to blink at a slower rate every 1 2 second e The LED will continue to blink until 25 capacity is reached The LED will then turn solid e Each of the four LEDs 25 100 will blink as stated above then turn solid when they reach their capacity e 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 MN123 1 rev F 14 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 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 CU002 1 Other lengths of tubing up to 25 ft 7 6 m maximum including nasal cannula may be used Cannula tubing must be non kinking which can be used for a total length of up to 25 ft 7 6 m maximum Ensure the cannula is fully inserted and secure This ensures that the Oxygen Concentrator can properly detect inspiration for oxygen delivery During inhalation you should hear or feel oxygen flow to the prongs of the nasal cannula Always follow the cannula manufacturer s instructions for proper use Replace the disposable cannula as recommended by the cannula manufacturer or your Equipment Provider
45. r 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 in place When disconnecting the power supply from the FreeStyle POC make sure you press down on the tab near the end of the cord to properly disengage the connection to the unit and release the cord Figure 14 Use with AC Electric Make sure your power supply is securely connected to the FreeStyle inlet as shown in Figure 14 Connect the proper end of the AC electrical cord to the unmarked AC inlet on the power supply as shown in Figure 15 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 To turn the unit off press the setting associated with the LED illuminated above it oo I S Figure 15 Figure 16 Use with DC Power Automobile Motorboat etc 21 Caution When using FreeStyle with the universal power supply in an automobile boat or other motor vehicle make sure that the vehicle is started and running before turning on and operating the FreeStyle unit If the power supply indicator light does not i
46. rate has exceeded the capacity of the FreeStyle unit A general malfunction has occurred Unit may be hot or cold if left outdoors such as in an automobile Internal battery exceeds charging temperature No power to the unit if battery depleted and DC outlet not charging Connect to DC or an AC outlet immediately Reduce activity and then turn unit off and back on again to reset unit If necessary change to another source of oxygen as available and contact your Equipment Provider Change to another source of oxygen as available and contact your Equipment Provider Allow the unit to reach normal operating temperature which may take several minutes if exposed to temperature extremes Temporarily connect your Universal AC DC power supply to the unit s power inlet and power source as needed to reset the unit s internal battery Unit may be operated however charging may not resume until battery temperature is reduced See page 9 notes Disconnect the Universal AC DC power supply from the automobile outlet restart the automobile and then reconnect the power supply into the automobile DC outlet to reset the breaker within DC power supply Change to another source of oxygen as available and contact your Equipment Provider 35 FreeStyle Specifications Oxygen Concentration Dimensions Weight Power Battery duration Rechargeable lithium Battery Battery recharge time Warm up time
47. s recommended to charge it after each use NOTE 2 Depending upon the temperature of the AirBelt 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 MN123 1 rev F 10 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 Patient manual not shown Universal AC DC power supply 100 240 volts 50 60 Hz with power cord DC Power Cable eo oe o Figure 1 FreeStyle Unit Figure 3 FreeStyle DC Power Optionally you may also have an AirBelt for extended battery duration That packaging contains the following as shown in Figure 4 e AirBelt battery belt e Universal AC DC power supply 100 240 Volt 50 60 Hz with power cord MN123 1 rev F 11 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 WARNING All AirBelt Warnings Cautions and Notes should be read first before proceeding with your equipment See pg 10 Important Safety Rules for Optional AirBelt Other optional access
48. tended for direct cardiac application Independent testing for Medical Electrical Equipment Standard Tested to be in compliance with IEC 60601 1 General Requirements for safety CAN CSA C22 2 No 60601 1 08 M90 Medical Electrical Equipment Part 1 General Requirements for Safety Protection against potential electromagnetic or other interference between the equipment and other devices Tested to be in compliance with EN60601 1 2 EMC Tested to be in compliance with RTCA DO160 Section 21 Category M 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 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 MN123 1 rev F 40 For European representative Medical Product Services GmbH MPS Borngasse 20 35619 Braunfels Germany Tel 49 0 6442 962073 E mail info mps gmbh eu 0459 For service on your FreeStyle Portable Oxygen Concentrator please contact your local Equipment Provider at Manufactured by tsil AirSep Corporation NIVA MIN MN123 1 Rev F
49. tudes may affect performance Based on an atmospheric pressure of 14 7 psi 101 kPa at 70 F 21 C Operating outside of these operational specifications can limit the concentrator s ability to meet Oxygen Concentration specification at higher liter flow rates MN123 1 rev F 36 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 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 Electrostatic discharge ESD IEC 61000 4 2 Electrical fast transient burst IEC 61000 4 4 Surge IEC 61000 4 5 Voltage dips short interruptions and voltage variations on power IEC 61000 4 11 Power frequency magnetic field IEC 61000 4 8 6 kV contact 8 kV air 2 kV for power supply lines 1 kV for input output lines 1 kV line to line 2 kV line to earth lt 5 Ur gt 95 dipin Ur for 0 5 cycle 40 Ur 60 dipin Ur for 5 cycles 70 Ur gt 30 dipin Ur for 25 cycles lt 5 Ur gt 95 dipin Ur for 5s 6 kV contact 8kVair 2 kV for power supply lines Not Applicable 1 kV line to line 2 kV line to earth lt 5 Ur
50. ure the cannula is fully inserted and secure This ensures that the Oxygen Concentrator can properly detect inspiration for oxygen delivery During inhalation you should hear or feel oxygen flow to the prongs of the nasal cannula Always follow the cannula manufacturer s instructions for proper use Replace the disposable cannula as recommended by the cannula manufacturer or your Equipment Provider Additional supplies are available from your Equipment Provider Charging of the battery may take several minutes after connecting the power to initiate depending on the battery s internal operating temperature This is a normal condition and is intended for safe battery charging This circumstance is more likely when the battery has been fully discharged If the device power supply remains connected when the battery is fully charged the four LEDs will turn off within approximately 1 hour For oxygen concentrators equipped with batteries The Oxygen Concentrator battery does not need to be fully discharged before recharging It is recommended to charge the Oxygen Concentrator battery after each use 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 35 F 23 C 2 C The use of some oxygen administration accessories not specif
51. vel a brief alarm sounds intermittently and the yellow 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 The level of battery charge is indicated by the battery gauge indicator s MN123 1 rev F 26 o Cannula disconnected When FreeStyle is operating but does not sense breathing a constant alarm sounds and the alarm light illuminates after 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 available and contact your Equipment Provider o FreeStyle s capacity is exceeded If your breathing rate causes the capacity of FreeStyle to be exceeded a rapid alarm sounds every second and the alarm light illuminates red intermittently When this occurs the concentration of oxygen that FreeStyle is supplying is outside of the unit specifications You should reduce any physical activity reset alarm by turning unit off and back on and then if necessary change
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