Vision Aire Oxygen Concentrator Patient Manual
Contents
1. e o A TM VistonAire 2 and e o TM VisionAire 3 Oxygen Concentrator Patient Manual AirSep Corporation e 401 Creekside Drive e Buffalo New York 14228 2085 USA Telephone 716 691 0202 e 24 Hour Fax 716 691 4141 Read the Important Safety Rules section before operating this equipment 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 EQUIPMEN OTHER INJURY OR DAMAGE COULD OCCUR Smoking while using oxygen is the number one cause of fire injury and death You must follow these safety nine 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 can cause facial burns and possibly result in death Removing the cannula and placing it on 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 pre2. administration accessories are recommended for use with the Oxygen Concentrator e Humidifier Bottle Part No HU003 1 e Nasal Cannula with 7 feet 2 1 m of tubing Part No CU002 1 The Manufacturer does not recommend the sterilization of this equipment If the unit has not been used for an extended time period it needs to operate for a minimum of several minutes before power failure alarm can become activated For units equipped with the oxygen monitor option When you turn the unit on it s normal for the amber OXYGEN MONITOR light to turn on and remain on for up to five minutes 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 The Manufacturer is not responsible for flooring that becomes discolored To prevent a void warranty follow all manufacturers instructions Do not attempt any maintenance other than the possible solutions listed within the manual 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 MNI165 1 Rev G Read the Important Safety Rules section before operating this equipment 1 0 Introduction This Patient Manual will acquaint you with AirSep s VisionAire 2 and VisionAire 3 Oxyge
3. 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 MN165 1 Rev G 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 2 or VisionAire 3 Oxygen Concentrator 2 1 Front of Concentrator Top Handle Oxygen Outlet Hour Meter Side Handle s a A Circuit Breaker owmeter Reset Button Adjustment Tag A AA p Knob 666 lt ON OFF 1 0 Power Switch VisiohAire D Operating Low Oxygen Instructions Concentration Label Indicator optional mandated for EU and specific countries Caster s Figure 1 Specification Label Figure la MNI165 1 Rev G 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
4. 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 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 liquids to enter the concentrator 15 MN165 1 Rev G 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 following pages for probable causes and solutions Do not attempt any maintenance other than the possible solutions listed within the manual 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 c
5. Class Type 8 Operating conditions 5 C to 40 C 41 F to 105 F at Environmental Limit altitudes up to 10 000 ft 523mmHg above sea level Conditions Storage 20 C 60 C 4 F 140 F Relative Humidity up to 95 RH non condensing 1 Performance based at 21 C 70 F at nominal operating pressure range 0 7 kPa 0 1 psig backpressure Maximum outlet pressure 55 kPa 7 98 psig 2 Operating outside of these operational specifications can limit the concentrators ability to meet Oxygen Concentration specification at higher liter flow rates 18 MN165 1 Rev G Read the Important Safety Rules section before operating this equipment 6 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 unit is intended for use in the electromagnetic environment specified below The customer or the user of the unit should assure that it is used in such an environment IEC 60601 Electromagnetic environment 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 IEC 61000 4 2 Electrical fast transient burst IEC 61000 4 4 Surge IEC 61000 4 5 Voltage dips short i
6. P d 2 3 x JP For transmitters rated at a maximum output power not listed above the recommended separation distance din 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 unit is intended for use in the electromagnetic environment specified below The customer or the user of the unit should assure that it is used in such an environment ar The unit uses RF energy only for its internal function Therefore its RF emissions are very RF emissions Group 1 low and are not likely to cause any interference in nearby electronic equipment CISPR 11 RF emissions The unit is suitable for use in all establishments including domestic establishments and Class B 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 21 MN165 1 Rev G Read the Important Safety Rules section befo
7. aire de votre fournisseur de mat riel Deutsche Eine mehrsprachige Version des Handbuchs ist in Ihrer Gerate Anbieter ii 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 VisionAire 2 and VisionAire 3 Oxygen Concentrator WARNING WARNING 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 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 1 0 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 acce
8. 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 unit used exceeds the applicable RF compliance level above the unit should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as re orienting or relocating the unit b Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m 20 MN165 1 Rev G Read the Important Safety Rules section before operating this equipment Recommended separation distances between portable and mobile RF communications equipment and the Unit The unit is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the unit can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the unit 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 80MHz from 80MHz to 80OMHz from 800MHz to 2 5GHz d 1 2 x VP d 1 2 x V
9. deliveries required The air we breathe contains approximately 21 oxygen 78 nitrogen and 1 other gases In the VisionAire 2 or VisionAire 3 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 delivered to the patient Note There is never a danger of depleting the oxygen in a room when you use your VisionAire 2 or VisionAire 3 unit MN165 1 Rev G 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
10. es e M Fitting Humidifier Bottle Oxygen Outlet Bottle 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 O Cannula 25 feet 7 6 m o AirSep part number CU002 4 O Humidifier Bottle Tubing o AirSep part number TU176 160 O Humidifier Bottle Fitting o AirSep part number F0655 1 O Oxygen Tubing 25 feet 7 6 m o AirSep part number CU004 3 Tubing Cannula Connector o AirSep part number CU009 1 11 MN165 1 Rev G 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 oGas Outlet Nozzle oOn Off Switch oHour Meter oFlowmeter oGas outlet oCircuit Breaker o Unit Labels oPower Cord oCord Strain relief oCord Wrap oDust Filter oHumidifier Strap oHumidifier Bottle o Cannula Tubing 2 6 Safety Features NOVA PS6201 Super High Impact Polystyrene Aluminum Black Anodized DuPont FR50 Acrylonitrile Butadiene Styrene ABS Plastic amp Acrylic ABS STAT TECH AS1000 Brass Button Melamine or Urea Formaldehyde Mounting Bushing Polyamide 66 Nylon Lexan Polyvinyl Chloride PVC Metal Nylon Velcro Polyester Yarn Rubber Top Acrylonitrile Butad
11. gen concentrator 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 The manufacturer is not responsible for flooring that becomes discolored 3 1 Humidifier Bottle Connection 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 e UA D Ne e If the humidifier bottle tubing is not properly connected to the humidifier bottle fitting or to the oxygen outlet an oxygen leak can occur CAUTICN 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 Concentra
12. gnetic interferences which exceed the levels specified by the EN 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 ST19 5NH England E mail eurorepcontact airsep com 0459 24 MN165 1 Rev G AREP Manufactured by AirSep Corporation Buffalo NY 14228 2085 USA
13. iene Styrene ABS Bottle Polypropylene PP Diffuser Polyvinyl Chloride PVC Polyvinyl Chloride PVC unit is operating and a loss of power occurs activate an audible 6 pulse intermittent y Compressor Motor Thermal safety is ensured by a thermostat situated in the stator winding 135 C 275 F A safety relief valve is fitted to the compressor outlet and is calibrated to 280 kPa 40 psig V Power Failure In the event the 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 y Hi Pressure An over pressure safety feature prevents potential damage to device components at a pressure of 207 kPa 30 psig 2 psig An audible 4 pulse intermittent alarm will activate Y 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 alarm Product Filter gt 10 micron 12 MN165 1 Rev G Read the Important Safety Rules section before operating this equipment 3 0 How To Operate Your Oxygen Concentrator Review the following information before you operate your oxy
14. ipement ou un technicien de service qualifi devrait enlever les couvercles ou faire l entretien de l unit 23 MN165 1 Rev G 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 requirements 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 electroma
15. ment Guidance and manufacturer s declaration electromagnetic immunity The unit is intended for use in the electromagnetic environment specified below The customer or the user of the unit should assure that it is used in such an electromagnetic environment IEC 60601 TEST Compliance 2 l Portable and mobile RF communications equipment should be used no closer Conducted RF 3 Vrms to any part of the unit including cables than the recommended separation IEC 61000 4 6 150 kHz to 80 MHz es from the equation applicable to the frequency of the Recommended separation distance Radiated RF 3 Vim 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 P is 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 Interference may occur in the vicinity of equipment marked with the following symbol w 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
16. n Concentrators 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 number 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
17. nterruptions and voltage variations on power IEC 61000 4 11 Power frequency magnetic field IEC 61000 4 8 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 5 Yo Ur gt 95 dipin Ur for 0 5 cycle 40 Ur 60 dipin Ur for 5 cycles 70 Ur 30 Ye dipin Ur for 25 cycles 5 Yo Ur gt 95 dipin Ur for 5s 8 kV air 2 KV for power supply lines Not Applicable 1 KV line to line 2 KV line to earth lt 5 Ur 95 Yo 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 295 dipin Ur for5s NOTE Uris the a c mains voltage prior to application of the test level 19 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 unit requires continued operation during power mains interruptions it is recommended that the unit 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 MN165 1 Rev G Read the Important Safety Rules section before operating this equip
18. or remains on for a few minutes and until the oxygen concentration reaches minimum concentration requirements only pertains to unit equipped with an Oxygen Monitor 5 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 6 The concentrator is now ready for use 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 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 CAUTION 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 Ensure the cannula is fully inserted and secure You should hear or feel oxygen flow to the prongs of the nasal cannula 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 the troubleshooting section of this manual En
19. ord 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 1 e 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 16 MN165 1 Rev G Read the Important Safety Rules section before operating this equipment Problem Probable Cause Solution Condensation Unit not properly Make sure unit is positioned away from collects in the ventilated curtains or drapes hot air registers or oxygen tubing Elevated operating heaters Be certain to place the unit so all when you use temperatures sides are at least 1 foot 30 cm away from a humidifier bottle a wall or other obstruction Do not place the unit in a confined area Refill h
20. r grease Proper disposal of waste of electrical and electronic equipment required Oxygen outlet connection to the cannula Do not expose to open flames a ONI 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 MN165 1 Rev G Read the Important Safety Rules section before operating this equipment Method of disposing of waste All waste from AirSep s VisionAire 2 and VisionAire 3 Oxygen Concentrator must be disposed of using the appropriate methods Method for disposing of the device In order to preserve the environment the concentrator must be disposed of using the appropriate methods Cet appareil produit de l oxyg ne 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 oxyg ne Ne pas utiliser de produits base d huile de graisse ou de WARNING R as NRE Oy AN n p trole sur ou proximit de l unit D connecter le cordon d alimentation de la prise lectrique avant de nettoyer ou de faire l entretien de l unit Risque de choc lectrique Ne pas enlever les couvercles lorsque l unit est branch e Seuls votre fournisseur d qu
21. re 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 2 and VisionAire 3 Oxygen Concentrators These symbols are referenced from the appropriate International Electro technical Commission IEC standards Symbol Description Symbol Description ON power switch on 0 OFF power switch off No smoking a Do not disassemble Type B equipment Consult instructions for use gt gt WAHRNING 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 Q b 3 5 zi Caution Describes a hazard or unsafe practice that if not avoided can result in minor bodily injury or property damage Complies with the 93 42 EEC directive drawn up by the approved organization No 0459 KI o 4 m Note Provides information important enough to emphasize or repeat Safety agency for CAN CSA C22 2 No 601 1 M90 for medical electrical equipment Consult the accompanying documents Keep unit and accessories dry P Use no oil o
22. sant 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 oxyg ne Ne pas utiliser de produits a 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 l entretien de l unit 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 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 unit so that it is difficult to access the power cord The concentrator should be located as to avoid smoke pollutants or fumes Ensure concentrator is operated in an upright position Always place oxygen supply tubing and power cords in a manner that prevents a trip hazard 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 unless the unit is plugged into a Ground Fault Circuit Interrupter GFCI protec
23. sed to clean the plastic housing on the 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 cloth not wet or sponge and then wipe all surfaces dry Do not allow any liquid to get inside the device 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 as 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 MN165 1 Rev G Read the Important Safety Rules section before operating this equipment WARNING CAUTIGN Cet appareil produit de l oxyg ne concentration lev e favori
24. sence 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 Read the Important Safety Rules section before operating this equipment Table of Contents Important Safety Rules Page 1 4 Section 1 Introduction Page 6 Why Your Physician Prescribed Oxygen Page 6 What is an Oxygen Concentrator Page 6 Operator Profile Page 7 Section 2 Concentrator Components Page 8 2 1 Front of Concentrator Page 8 9 2 2 Back of Concentrator Page 10 2 3 Humidifier Bottle Page 11 2 4 Accessories Page 11 2 5 Materials in direct or indirect contact with the patient Page 12 2 6 Safety Features Page 12 Section 3 How to Operate Your Oxygen Concentrator Page 13 3 1 Humidifier Bottle Connection Page 13 3 2 Cannula Connection Page 13 3 3 Starting the Concentrator Page 13 3 4 Turning the Concentrator Off Page 14 Section 4 Care and Cleaning Page 15 4 1 Humidifier Bottle Page 15 4 2 Outside Cabinet Page 15 Section 5 Troubleshooting Page 16 17 Section 6 Product Specifications Page 18 21 Section 7 Symbols Abbreviations Page 22 Section 8 Conformity with EN 60 601 6 8 2 b Page 24 Classification English A multilingual version of the manual is available through your equipment provider Espanol Una version multiling e del manual esta disponible a trav s de su proveedor de equipo Francais Une version multilingue du manuel est disponible par l interm di
25. sound at all consult your Equipment Provider immediately For units equipped with the oxygen monitor option Contact your Equipment Provider immediately if the amber OXYGEN MONITOR light remains on for more than 15 minutes and or the audio alarm activates If the humidifier bottle tubing is not properly connected to the humidifier bottle fitting or to the oxygen outlet an oxygen leak can occur Cannula must be non kinking which can be used for a total length of 25 ft 7 6 m max Ensure the cannula is fully inserted and secure You should hear or feel oxygen flow to the prongs of the nasal cannula 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 the troubleshooting section of this manual 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 MN165 1 Rev G Read the Important Safety Rules section before operating this equipment The use of some oxygen administration accessories not specified for use with this oxygen concentrator may impair its performance Recommended accessories are referenced within this manual To Equipment Provider The following oxygen
26. ssories 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 impairments may need assistance with monitoring the alarms If you feel discomfort or are experiencing a medical emergency seek medical assistance immediately MN165 1 Rev G Read the Important Safety Rules section before operating this equipment WARNING WARNING WARNING Electrical shock hazard Turn Offthe unit and 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 Care should be taken to prevent the Oxygen Concentrator from getting wet or allowing fluids to enter the unit This can cause the unit to 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 u
27. sure concentrator is operated in an upright position CAUTION 3 4 Turning the Concentrator Off e Set the I 0 power switch to the 0 position to turn off the unit 14 MN165 1 Rev G 4 0 Read the Important Safety Rules section before operating this equipment Care and Cleaning Electrical shock hazard Turn Off the unit and 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 WARNING service technician should remove the covers or service the unit 4 1 4 2 Care should be taken to prevent the Oxygen Concentrator from getting wet or allowing fluids to enter the unit This can cause the unit to 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 the unit 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 cloth or sponge and then wipe all surfaces dry Do not allow any liquid to get inside the device Always follow the cannula manufacturer
28. ted outlet Do not operate this unit in a restricted or confined space where ventilation can be limited This can cause the device to overheat and affect performance Do not allow either the air intake or the air outlet vents to be blocked DO NOT drop or insert any object into any openings on the device This can cause the Oxygen Concentrator to overheat and impair performance MN165 1 Rev G Read the Important Safety Rules section before operating this equipment CAUTION 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 Oxygen Concentrator may be used during sleep under the recommendation of a licensed clinician Operating or storing the Oxygen Concentrator outside of its normal operating temperature range can impair the performance of the unit Refer to the specification section of this manual for storage and operating temperature limits In the event of an alarm or you observe the Oxygen Concentrator is not working properly consult the troubleshooting section of this manual If you cannot resolve the problem consult your Equipment Provider If the audio alarm is weak or does not
29. tor 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 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 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 CAUTIGN and smoke free location away from direct sunlight Do not operate the unit outdoors unless the unit is plugged into a Ground Fault Circuit GFCI protected outlet 13 MN165 1 Rev G Read the Important Safety Rules section before operating this equipment 1 Locate the unit near the electrical outlet in the room where you spend most of your time 2 Insert the power cord plug into the electrical outlet 3 Set the l O power switch to the I position to turn the unit on An audible alarm will loudly sound for approximately 5 seconds 4 The low oxygen concentration indicat
30. umidifier 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 0 power switch to 0 position use your reserve oxygen supply if provided and consult your Equipment Provider immediately Set I 0 power switch to the 0 position use your reserve oxygen supply if provided All other problems and consult your Equipment Provider immediately Oxygen O Set I O power switch to the 0 position use xygen f Concentration TON your reserve oxygen supply if provided Indicator remains k YN and consult your Equipment Provider lt 82 43 lit amber immediately 17 MN165 1 Rev G Read the Important Safety Rules section before operating this equipment 6 0 PRODUCT SPECIFICATIONS e on TM A m TM VisionAire 2 and VisionAire 3 ie 2 lpm 3 lpm W Flow Specifications pm 2 Ipm 10 of indicated setting or 200 mL whichever is greater Oxygen Concentration 90 5 5 3 115 VAC 60 Hz 3 0 A Electrical Requirements 230 VAC 50 Hz 1 5 A 230 VAC 60 Hz 1 5 A P C ti VisionAire 2 200 Watts 10 Lo Fri VisionAire 3 175 Watts 10 Sound Di A 14 1 in W x 11 5 in D x 20 8 in H TS 35 8 cm W x 29 2 cm D x 52 8 cm H 30 bs 136 k0 Electrical Shock Protection
31. 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 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 MN165 1 Rev G Read the Important Safety Rules section before operating this equipment 2 2 Back of Concentrator Humidifier Bottle Recess Power Cord Figure 2 V Power Cord o Allows connection of the unit to an electrical outlet Y Humidifier Bottle Recess o Area to place the optional humidifier bottle 10 MNI165 1 Rev G Read the Important Safety Rules section before operating this equipment 2 3 Humidifier Bottle optional Humidifier Bottle Tubing Dxygen Tubing Cannula 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 Humidifier Bottle SO s
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