VisionAire 5 Patient Manual
Contents
1. Important Safety Rules Page 1 4 Section 1 Introduction Page 5 Why Your Physician Prescribed Oxygen Page 5 What is an Oxygen Concentrator Page 5 Operator Profile Page 6 Section 2 Concentrator Components Page 7 2 1 Front of Concentrator Page 7 8 2 2 Back of Concentrator Page 9 23 Humidifier Bottle Page 10 2 4 Accessories Page 10 25 Materials in direct or indirect contact with the patient Page 11 2 6 Safety Features Page 11 Section 3 How to Operate Your Oxygen Concentrator Page 12 3 1 Humidifier Bottle Connection Page 12 3 2 Cannula Connection Page 12 3 3 Starting the Concentrator Page 12 3 4 Turning the Concentrator Off Page 13 Section 4 Care and Cleaning Page 14 4 1 Humidifier Bottle Page 14 4 2 Outside Cabinet Page 14 Section 5 Troubleshooting Page 15 16 Section 6 Product Specifications Page 17 20 Section 7 Symbols Abbreviations Page 21 Section 8 Conformity with EN 60 601 6 8 2 b Page 23 Classification English A multilingual version of the manual is available through your equipment provider Espa ol Una versi n multiling e del manual est disponible a trav s de su proveedor de equipo Fran ais Une version multilingue du manuel est disponible par l interm diaire de votre fournisseur de mat riel Deutsche Eine mehrsprachige Version des Handbuchs ist in Ihrer Ger te Anbieter i MN136 1 rev H 7 13 Read the Important Safety Rules section before operating this equioment Important Safety Rules Care2. Optimal oxygen concentration is obtained within 10 minutes after the device is switched on 90 of the concentration is obtained after approximately 5 minutes It is very important to follow the prescribed level of oxygen flow Do not CAUTION increase or decrease the flow until you first consult your physician Normally you should not need to adjust the flowmeter on your unit If you turn the flowmeter adjustment knob clockwise you will decrease and can shut off the flow of oxygen from your unit CAUTION If oxygen does not seem to flow first verify that the flowmeter ball is registering a flow Then place the tip of the cannula into a glass of water if bubbles come out of the cannula oxygen is flowing If bubbles do not appear refer to Section 5 0 Troubleshooting Ensure concentrator is operated in an upright position 3 4 Turning the Concentrator Off e Set the UD power switch to the 0 position to turn off the unit 13 MN136 1 rev H 4 0 Read the Important Safety Rules section before operating this equioment Care and Cleaning the unit to prevent accidental electrical shock hazards Only your Disconnect the power cord from the electrical outlet before you clean WARNING Equipment Provider or a qualified service technician should remove the covers or service the unit Do not use liquid directly on the unit A list of undesirable chemical based products concentrated chlorine based p
3. operate this unit in a restricted or confined space where ventilation can be limited This can cause the device to overheat and affect performance In the event of an alarm or you observe the unit is not working properly consult the troubleshooting section of this manual If you cannot resolve the problem consult your Equipment Provider The Oxygen Concentrator may be used during sleep under the recommendation of a qualified clinician If the humidifier bottle tubing is not properly connected to the humidifier bottle fitting or to the oxygen outlet an oxygen leak can occur Storing the device outside of its temperature specifications may affect performance refer to the specification section of the manual Do not position the unit so that it is difficult to access the power cord 3 MN136 1 rev H Read the Important Safety Rules section before operating this equioment The concentrator should be located as to avoid pollutants or fumes If oxygen does not seem to flow first verify that the flowmeter ball is registering a flow Then place the tip of the cannula into a glass of water if bubbles come out of the cannula oxygen is flowing If bubbles do not appear refer to Section 5 0 Troubleshooting To prevent a voided AirSep warranty follow all manufacturers instructions Replace the disposable cannula periodically following normal usage according to your Equipment Providers recommendations AirSep does not recom
4. too many plugs into the same electrical outlet This can result in an overload to the electrical panel causing the breaker fuse to activate WARNING Position the unit away from curtains or drapes hot air registers or heaters Be certain to place the unit on a flat surface and make sure all sides are at least 1 foot 30 cm away from a wall or other obstruction Do not place CAUTION the unit in a confined area Choose a dust and smoke free location away from direct sunlight Do not operate the unit outdoors 12 MN136 1 rev H Read the Important Safety Rules section before operating this equipment Se D Locate the unit near the electrical outlet in the room where you spend most of your time Insert the power cord plug into the electrical outlet Set the I O power switch to the I position to turn the unit on An audible alarm will loudly sound for approximately 5 seconds The low oxygen concentration indicator remains on for a few minutes and until the oxygen concentration reaches minimum concentration requirements only pertains to unit equipped with an Oxygen Monitor To set the flow of supplemental oxygen turn the flowmeter adjustment knob left or right until the ball inside the flowmeter centers on the flow line number prescribed by your physician To view the flowmeter at the proper angle note that the back line and the front number line must give appearance of one line The concentrator is now ready for use
5. whichever is greater Oxygen Concentration 90 5 5 3 115 VAC 60 Hz 3 0A Electrical Requirements 230VAC 50 Hz 1 5A 230VAC 60 Hz 1 5A Power Consumption 290 Watts Di 14 1 in W x 11 5 in Dx 20 8 in H UNENSIONS 35 8 cm W x 29 2 cm D x 52 8 cm H Electrical Shock Protection Class II Type B Operating conditions 5 C to 40 C 41 F to 105 F at altitudes up to 10 000 ft 523mmHg above sea level Storage 20 C 60 C 4 F 140 F Relative Humidity up to 95 RH non condensing Environmental Limit Conditions 1 Based on 21 C 70 F at a nominal operating pressure range of 0 7 kPa 0 1 psig back pressure Maximum output pressure 55 kPa 7 98 psig 2 Operating outside of these operational specifications can limit the concentrator s ability to meet Oxygen Concentration specification at higher liter flow rates 17 MN136 1 rev H Read the Important Safety Rules section before operating this equioment Specifications continued _ Medical equipment needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in this section Guidance and manufacturer s declaration electromagnetic immunity The VisionAire is intended for use in the electromagnetic environment specified below The customer or the user of the VisionAire should assure that it is used in such an environment IEC 60601 e Electromagnetic e
6. 00 4 8 Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment NOTE Uris the a c mains voltage prior to application of the test level 18 MN136 1 rev H Read the Important Safety Rules section before operating this equioment Guidance and manufacturer s declaration electromagnetic immunity The VisionAire is intended for use in the electromagnetic environment specified below The customer or the user of the VisionAire should assure that it is used in such an electromagnetic environment IEC 60601 TEST Compliance p S Portable and mobile RF communications equipment should be used no Conducted RF IEC 3 Vrms closer to any part of the VisionAire including cables than the recommended separation distance calculated from the equation 61900 46 150 kHz to 80 MHz applicable to the frequency of the transmitter Recommended separation distance Radiated RF IEC 3 V m D 1 2 x VP 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 meters 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 following symbol Interference may Y i
7. 2 EEC directive drawn up by the approved organization CAUTION property damage 459 No 0459 Note Provides information 3 Safety agency for CAN CSA C22 2 No important enough to emphasize Bras 601 1 M90 for medical electrical NOTE or repeat ie equipment Consult the accompanying documents Keep unit and accessories dry Use no oil or grease Proper disposal of waste of electrical and electronic equipment required Oxygen outlet connection to the cannula Do not expose to open flames K ON Y Caution Federal law USA restricts this for sale or rental by or on the order of a physician or licensed health care provider Keep in the vertical position Ha Fragile handle with care Oxygen concentration warning LED See Instructions MN136 1 rev H Read the Important Safety Rules section before operating this equipment Method of disposing of waste All waste from AirSep s VisionAire Oxygen Concentrator must be disposed using the appropriate methods specified by local authorities Method for disposing of the device In order to preserve the environment the concentrator must be disposed using the appropriate methods specified by local authorities Cet appareil produit de l oxyg ne concentration lev e favorisant une combustion rapide Ne pas permettre de fumer ou des flammes nues dans un rayon de 5 pieds 1 5 m tre de 1 cet appareil ou 2 tout accessoire con
8. JAR EP VisionAire Oxygen Concentrator Patient Manual AirSep Corporation e 401 Creekside Drive e Buffalo New York 14228 2085 USA Telephone 716 691 0202 24 Hour Fax 716 691 4141 WARNING 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 injury and death You must follow these safety warnings Do not allow smoking candles or open flames within the same room of the device or the oxygen carrying accessories Smoking while wearing an oxygen cannula may result in facial burns and possibly death Removing the cannula and placing it on surfaces such as bedding sofas or other cushion material will cause a flash fire when exposed to a cigarette heat source or flame If you smoke you must follow these 3 life saving steps 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 the oxygen concentrator is in use Patients and their caregivers must be informed about the dangers of smoking in the presence of or while using medical oxygen Read the Important Safety Rules section before operating this equipment
9. O off position when the VisionAire unit is not in use Do not use extension cords with this unit or connect too many plugs into the same electrical outlet This can result in an overload to the electrical panel causing the breaker fuse to activate 1 MN136 1 rev H Read the Important Safety Rules section before operating this equioment A WARNING A WARNING A WARNING A WARNING A WARNING A WARNING A WARNING A WARNING Use only voltage specified on back panel label 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 Care should be taken to prevent unit from getting wet or allowing water to enter the unit This can cause the unit to malfunction or shut down and cause an increased risk for electrical shock or burns Disconnect the power cord from the electrical outlet before you clean the unit to prevent accidental electrical shock hazards Only your Equipment Provider or a qualified service technician should remove the covers or service the unit 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 the unit as they ca
10. Operating Instructions Label o Directs usage of the unit Casters o Four casters enable unit to be easily moved as needed Specification Label o Displays electrical specifications and serial number 8 MN136 1 rev H Read the Important Safety Rules section before operating this equipment 22 Back of Concentrator Humidifier Bottle Recess Power Cord Figure 2 Power Cord o Allows connection of the unit to an electrical outlet Y Humidifier Bottle Recess o Area to place the optional humidifier bottle 9 MN136 1 rev H Read the Important Safety Rules section before operating this equipment 2 3 Humidifier Bottle optional Humidifier Bottle Tubing Oxygen Tubing Cannula Humidifier Bottle p KEAAE Fitting Humidifier Bottle Oxygen Outlet Humidifier Bottle Figure 3 Humidifier Bottle optional o Humidifies the oxygen before it reaches the patient Humidifier Bottle Oxygen Outlet o Connection for oxygen tubing cannula 2 4 Accessories Recommended for use with VisionAire 2 and VisionAire 3 The use of certain administration accessories which are not specified for use with this concentrator may reduce performance and void the manufacturer s warranty Humidifier Bottle o AirSep part number HU003 1 Cannula 25 feet 7 6 m o AirSep part number CU002 4 Humidifier Bottle Tubing o AirSep part number TU176 160 Humidifier Bottle Fitting o AirSep part nu
11. em Probable Cause Solution Condensation collects in the oxygen tubing when you use a humidifier bottle Unit not properly ventilated Elevated operating temperatures Make sure unit is positioned away from curtains or drapes hot air registers or heaters Be certain to place the unit so all sides are at least 1 foot 30 cm away from a wall or other obstruction Do not place the unit in a confined area Refill humidifier bottle with COLD water DO NOT OVERFILL Allow oxygen tubing to dry out or replace with new tubing Intermittent alarm sounds at one second intervals See section 2 6 Safety Features for a description of auditory indicators Set I O power switch to 0 position use your reserve oxygen supply if provided and consult your Equipment Provider immediately Set I O power switch to the 0 position use your reserve oxygen supply if provided All other problems and consult your Equipment Provider immediately Oxygen Oxygen Set I O power switch to the 0 position use Concentration your reserve oxygen supply if provided Indicator remains lit amber concentration is lt 82 43 and consult your Equipment Provider immediately 16 MN136 1 rev H Read the Important Safety Rules section before operating this equipment 6 0 Product Specifications VisionAire Oxygen Concentrator Flow Specifications D PIT 10 of indicated setting or 200 mL
12. er abilities required for concentrator use 6 MN136 1 rev H Read the Important Safety Rules section before operating this equipment 2 0 Concentrator Components Review the figures below and become familiar with the important parts of your VisionAire Oxygen Concentrator 2 1 Front of Concentrator Top Handle Oxygen Outlet our Meter Side Handles Circuit Breaker Flowmeter Reset Button Adjustment Knob ON OFF 1 0 Power Switch Operating Low Oxygen Instructions Concentration Label Indicator optional mandated for EU and specific countries Caster s Figure 1 Specification i V0245905 Label emmmer Figure la 7 MN136 1 rev H Read the Important Safety Rules section before operating this equipment Top and Side Handles o Enables convenience in carrying the unit On Off 1 0 Power Switch o Starts and stops the operation of the unit Oxygen Outlet o Provides connection for a humidifier if required or cannula Circuit Breaker Reset Button o Resets the unit after electrical overload shutdown Flowmeter Adjustment Knob o Controls the oxygen flow rate in liters per minute LPM Low Oxygen Concentration Indicator optional mandated for EU and specific countries o When equipped with an Oxygen Monitor a warning LED amber is activated on the front panel see Section 2 6 Safety Features for details Hour Meter o Records the concentrator s cumulative hours of operation
13. fully review and familiarize yourself with the following important safety information about the VisionAire Oxygen Concentrator WARNING 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 This unit is not to be used for life support Geriatric pediatric or any other patient unable to communicate discomfort while using this oxygen concentrator may require additional monitoring Patients with hearing and or sight impairments may need assistance with monitoring the alarms If you feel discomfort or are experiencing a medical emergency seek medical assistance immediately Use no oil grease or petroleum based or other flammable products on or near nasal end of cannula or on the unit Oxygen accelerates the combustion of flammable substances Electrical shock hazard Disconnect the power cord from the electric 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 Do not leave a nasal cannula under 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
14. ining a minimum distance between portable and mobile RF communications equipment transmitters and the VisionAire as recommended below according to the maximum output power of the communications equipment Separation distance according to frequency of transmitter Rated maximum output m ft itt SE from 150kHz to 80MHz from 80MHz to 800MHz from 800MHz to 2 5GHz d 1 2 x VP d 1 2 x VP d 2 3 x P 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 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 VisionAire is intended for use in the electromagnetic environment specified below The customer or the user of the VisionAire should assure that it is used in such an environment ae The VisionAire uses RF energy only for its internal function Therefore its RF emissions RF emissions Group 1 are very low and are not likely to cause any interference in nearby electronic equipment CISPR 11 RF emissions The Visi
15. lief valve is fitted to the compressor outlet and is calibrated to 280 kPa 40 psig Y Power Failure In the event the unit is operating and a loss of power occurs an audible single pulse intermittent alarm will activate Y Oxygen Monitor The oxygen monitor detects any drop in concentration below 82 3 and activates a visual alarm amber LED indicator on front panel If the concentration continues to operate below 82 an audible 2 pulse intermittent alarm will also activate V Hi Pressure An over pressure safety feature prevents potential damage to device components at a pressure of 228 kPa 33 psig 2 psig An audible 4 pulse intermittent alarm will activate V Low Pressure An audible 3 pulse intermittent alarm will activate if the device pressure reduces to lt 35 kPa 5 psig 1 psig Y No Flow Warning An obstruction to the flow of oxygen such as a pinch or kink in the delivery cannula will activate an audible 6 pulse intermittent alarm Product Filter gt 10 um filter 11 MN136 1 rev H Read the Important Safety Rules section before operating this equioment 3 0 How To Operate Your Oxygen Concentrator Review the following information before you operate your oxygen concentrator permanently discolor temperature sensitive flooring surfaces such as vinyl Pa The concentrator releases warm air out the bottom of the unit which can The concentrator should not be used over flooring that is sen
16. livered to the patient Note There is never a danger of depleting the oxygen in a room when you use your VisionAire unit 5 MN136 1 rev H Read the Important Safety Rules section before operating this equipment Operator Profile AirSep s Stationary Concentrators are intended to supply supplemental Oxygen to users suffering from discomfort due to ailments which affect the efficiency of ones lungs to transfer the oxygen in air to their bloodstream Users can benefit from supplemental oxygen therapy for respiratory care at home in the hospital or at a medical facility Oxygen Concentrator use requires a physician s prescription and are 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 disease 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 1 e cylinder oxygen in the event of a power outage or concentrator failure There are no other unique skills or us
17. mber F0655 1 Oxygen Tubing 25 feet 7 6 m o AirSep part number CU004 3 Tubing Cannula Connector o AirSep part number CU009 1 10 MN136 1 rev H Read the Important Safety Rules section before operating this equipment 2 5 Materials in direct or indirect contact with the patient oConcentrator Cabinet all parts NOVA PS6201 Super High Impact Polystyrene oGas Outlet Nozzle Aluminum Black Anodized oOn Off Switch DuPont FR50 OHotir Meter Acrylonitrile Butadiene Styrene ABS Plastic amp Acrylic e Se E ABS STAT TECH AS1000 OGasoutl t edu Brass oCircuit Breaker Button Melamine or Urea Formaldehyde Mounting Bushing Polyamide 66 Nylon GUnit Labels Lexan oPow r Cordes ae nee Polyvinyl Chloride PVC Metal oCord Strain relief Nylon OCord Wrap ion nest fetes Velcro o Dust Filter due sogceniessistes uen Polyester oHumidifier Strap VYarn Rubber oHumidifier Bottle Top Acrylonitrile Butadiene Styrene ABS en ae pues Bottle Polypropylene PP Diffuser Polyvinyl Chloride PVC o Cannula Tubing Polyvinyl Chloride PVC 2 6 Safety Features Compressor Motor Thermal safety is ensured by a thermostat situated in the stator winding 135 C 275 F A safety re
18. mend the sterilization of this equipment Do not attempt any maintenance other than the possible solutions listed below If the unit has not been used for an extended time period it needs to operate for several minutes before power failure alarm can become activated Portable and mobile RF communications equipment can affect medical electrical equipment The concentrator releases warm air out the bottom of the unit which can permanently discolor temperature sensitive flooring surfaces such as vinyl The concentrator should not be used over flooring that is sensitive to heat staining AirSep is not responsible for flooring that becomes discolored No Smoking Oxygen in Use signs must be prominently displayed in the home or where the oxygen concentrator is in use Patients and their caregivers must be informed about the dangers of smoking in the presence of or while using medical oxygen 4 MN136 1 rev H Read the Important Safety Rules section before operating this equipment 1 0 Introduction This Patient Manual will acquaint you with AirSep s VisionAire Oxygen Concentrator Make sure you read and understand all of the information contained in this guide before operating your concentrator Should you have any questions your Equipment Provider will be happy to answer them for you Why Your Physician Prescribed Oxygen Many people today suffer from a variety of heart lung and other respiratory diseases A significant n
19. n damage the unit s plastic Clean the cabinet control panel and power cord only with a mild household cleaner applied with a damp cloth or sponge and then wipe all surfaces dry Do not allow any liquid to get inside the device No modification of this equipment is allowed The unit 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 Federal USA law restricts this device to sale or rental by order of a physician or other licensed health care provider 2 MN136 1 rev H Read the Important Safety Rules section before operating this equioment AirSep 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 follow the prescribed level of oxygen flow Do not increase or decrease the flow until you first consult your physician Ensure concentrator is operated in an upright position Position the unit away from curtains or drapes hot air registers or heaters Be certain to place the unit on a flat surface and make sure all sides are at least 1 foot 30 cm away from a wall or other obstruction Do not place the unit in a confined area Choose a dust and smoke free location away from direct sunlight Do not operate the unit outdoors Do not
20. n the vicinity of equipment marked with the i 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 VisionAire is used exceeds the applicable RF compliance level above the VisionAire should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as re orienting or relocating the VisionAire b Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m 19 MN136 1 rev H Read the Important Safety Rules section before operating this equipment Recommended separation distances between portable and mobile RF communications equipment and the VisionAire The VisionAire is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the VisionAire can help prevent electromagnetic interference by mainta
21. nvironment Electrostatic 6 kV contact 6 kV contact Floors should be wood concrete or ceramic tile If floors are discharge ESD covered with synthetic material the relative humidity should be 8 KV air 8 KV air at least 30 IEC 61000 4 2 Electrical fast transient burst IEC 61000 4 4 Mains power quality should be that of a typical commercial or hospital environment 2 kV for power supply lines 2 KV for power supply lines 1 KV for input output lines Not Applicable Mains power quality should be that of a typical commercial or hospital environment Surge 1 KV line to line 1 KV line to line IEC 61000 4 5 Voltage dips short interruptions and voltage variations on power IEC 61000 4 11 2 KV line to earth lt 5 K Ur 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 K Ur gt 95 dipin Ur for 5s 2 KV line to earth lt 5 K Ur 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 K Ur gt 95 dipin Ur for bs Mains power quality should be that of a typical commercial or hospital environment If the user of the VisionAire requires continued operation during power mains interruptions it is recommended that the VisionAire be powered from an uninterruptible power supply UPS or a battery Power frequency magnetic field IEC 610
22. ollowing pages for probable causes and solutions Do not attempt any maintenance other than the possible solutions listed below If the unit has not been used for an extended time period it needs to operate for several minutes before power failure alarm can become activated Problem Probable Cause Solution Unit does not operate Power failure condition causes an alarm to sound The power cord is not connected to the electrical outlet No power at the electrical outlet Circuit breaker on concentrator unit is activated Check power cord at the electrical outlet for a proper connection Check power source wall switch in house fuse or circuit breaker Press do not hold in the circuit breaker reset button in the front of the unit If the circuit breaker trips again or the alarm continues to sound after the unit is turned on contact your Equipment Provider Limited or no oxygen flow Dirty or obstructed humidifier bottle or leak present Defective nasal cannula or other oxygen accessories Le oxygen tubing Cannula tubing loose Remove the humidifier bottle and if flow is restored clean or replace the humidifier bottle Remove and check accessories for kinks or obstructions Replace if needed Check cannula tubing connection at control panel MN136 1 rev H Read the Important Safety Rules section before operating this equipment Probl
23. onAire is suitable for use in all establishments including domestic establishments Class B and those directly connected to the public low voltage power supply network that supplies CISPR 11 buildings used for domestic purposes Harmonic emissions Class A IEC 61000 3 2 Voltage fluctuations flicker emissions Complies IEC 61000 3 3 20 MN136 1 rev H Read the Important Safety Rules section before operating this equipment 7 0 Symbols Abbreviations Symbols are frequently used on equipment in preference to words with the intention of lessening any 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 that may be used with AirSep s VisionAire Oxygen Concentrator These symbols are referenced from the appropriate International Electro technical Commission IEC standards Symbol Description Symbol Description ON power switch on OFF power switch off No smoking Do not disassemble Type B equipment Consult instructions for use gt gt WARNING Warning Describes a hazard or unsafe practice that if not avoided can result in severe bodily injury death or property damage Class II Device gt Caution Describes a hazard or unsafe practice that if not avoided can result in minor bodily injury or Complies with the 93 4
24. rements of the MDD 93 42 EEC 2007 47 EC Annex I European directive but its operation may be affected by other devices being used close by such as diathermy and high frequency electro surgical equipment defibrillators short wave therapy equipment mobile telephones CB and other portable devices microwave ovens induction plates or even remote control toys and more generally electromagnetic interferences which exceed the levels specified by the ECN 60601 1 2 standard Classification Type of protection against electric shock Class II Protection from electric shock is achieved by DOUBLE INSULATION Protective earthing or reliance upon installation conditions are not required Degree of protection against electric shock Type B Equipment providing a particular degree of protection against electric shock particularly regarding 1 Allowable leakage current 2 Reliability of protective earth connection if present Not intended for direct cardiac application Method of cleaning and infection control allowed Please refer to your Equipment Provider and the VisionAire Service Manual Degree of safety of application in the presence of flammable gases Equipment not suitable for such application Mode of operation Continuous duty For European Representative Gavin Ayling 9 Bungham Lane Penkridge Stafford Staffordshire ST 19 5NH England CE E mail eurorepcontact airsep com 23 MN136 1 rev H E Manufactured by AirSep Corpora
25. roducts ethylene agents includes but is not limited to the following alcohol and alcohol WARNING chloride and oil based products Pine Sol Lestoil These are NOT to be used to clean the plastic housing on the unit as they can damage the unit s plastic household cleaner applied with a damp cloth or sponge and then wipe Clean the cabinet control panel and power cord only with a mild all surfaces dry Do not allow any liquid to get inside the device WARNING 4 1 4 2 Replace the disposable cannula periodically following normal usage according to your Equipment Providers recommendations To prevent a voided AirSep warranty follow all manufacturers instructions AirSep does not recommend the sterilization of this equipment Humidifier Bottle optional e Check water level daily and add water as needed e To clean and disinfect the humidifier follow your Equipment Provider s instructions or the instructions included with the humidifier bottle Outside Cabinet Use a mild household cleaner applied with a damp cloth or sponge to clean the exterior of the concentrator and then wipe all surfaces dry Do not allow any liquid to get inside the device 14 MN136 1 rev H Read the Important Safety Rules section before operating this equipment 5 0 Troubleshooting If your concentrator fails to operate properly consult your Equipment Provider and refer to the troubleshooting chart on the f
26. sitive to heat NOTE staining AirSep is not responsible for flooring that becomes discolored 3 1 Humidifier Bottle Optional If additional humidification is required with your oxygen therapy perform the following steps each time you fill or clean the humidifier which may have been initially set up for your use Remove the humidifier bottle from the humidifier bottle recess Open the humidifier bottle If you have a pre filled bottle do not perform this step Proceed to step 5 Fill the humidifier bottle with cool or cold water distilled water is preferred to the fill line indicated on the bottle DO NOT OVERFILL Re connect the top cover to the humidifier bottle Place the humidifier bottle in the humidifier bottle recess on the back of the concentrator and connect the humidifier bottle tubing to the oxygen outlet and the humidifier bottle fitting DE NE If the humidifier bottle tubing is not properly connected to the humidifier bottle fitting or to the oxygen outlet an oxygen leak can occur CAUTION 3 2 Cannula Connection Connect the tubing and cannula to the unit s oxygen outlet or to the optional humidifier s oxygen outlet 3 3 Starting the Concentrator NO SMOKING signs must be prominently displayed in the home or wherever unit is in use Patients and their contacts should be informed about the dangers of smoking in the presence of medical oxygen Do not use extension cords with this unit or connect
27. tenant de l oxyg ne Ne pas utiliser de produits base d huile de graisse ou de p trole sur ou proximit de l unit D connecter le cordon d alimentation de la prise lectrique avant de nettoyer ou de faire Ventretien de l unit WARNING Risque de choc lectrique 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 unit 22 MN136 1 rev H Read the Important Safety Rules section before operating this equipment 8 0 Conformity with EN 60 601 6 8 2 b Classification The manufacturer assembler installer or importer are not considered to be responsible themselves for the consequences on the safety reliability and characteristics of a device unless The assembly fitting extensions adjustments modifications or repairs have been performed by persons authorized by the party in question The electrical installation of the corresponding premises complies with IEC regulations The device is used in accordance with the instructions for use If the replacement parts used for the periodic servicing by an approved technician do not comply with the manufacturer s specifications the latter is absolved from all responsibility in the event of an accident Do not open the device while in operation risk of electrical shock This device complies with the requi
28. tion Buffalo NY 14228 2085 USA
29. umber of these patients can benefit from supplemental oxygen therapy for respiratory care at home in the hospital or at a medical facility 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 has prescribed supplemental oxygen therapy because your body is not able to get enough oxygen from room air Oxygen is a non addictive drug and your physician prescribed a flow sufficient to improve your condition Please keep in mind that unauthorized oxygen therapy can be dangerous You must seek medical advice before you use this unit The Equipment Provider who supplies your oxygen equipment will demonstrate how to set the prescribed flow rate What is an Oxygen Concentrator Oxygen concentrators were introduced in the mid 1970s and have become the most convenient reliable source of supplemental oxygen available today Without an oxygen concentrator the average patient would require a delivery of 12 bottles cylinders of oxygen each month Your oxygen concentrator produces all the oxygen you need with no deliveries required The air we breathe contains approximately 21 oxygen 78 nitrogen and 1 other gases In the VisionAire unit room air passes through a regenerative adsorbent material called molecular sieve This material separates the oxygen from the nitrogen and other gases The result is a constant supply of high concentration supplemental oxygen that is de
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