06/29/30-1st mark-up
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1. Patient Manual Focus Portable Oxygen Concentrator EEE NETT 260 Creekside Drive Buffalo NY 14228 2085 USA 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 COULD OCCUR Smoking while using oxygen is the number one cause of fire injuries and related deaths You must follow these safety warnings WARNING Do not allow smoking candles or open flames in the same room with 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 flame 4 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 1s located No Smoking Oxygen in Use signs must be prominently displayed in the home or where the 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 CAUTI2. 12 Volt DC outlet Connect the power supply cord labeled DC OUT To Focus into the Focus unit s power inlet as shown in Figure 8 Place the DC accessory adapter on the end of the DC power cord Connect the other end into the power supply input connection labeled Accessory DC IN You can then connect the DC power cord with adapter attached into the 12 Volt DC power source Do not force the cords as they can be inserted only one way aaa DC OUT to Focus DC accessory adapter Connect to Focus Accessor DC power cord Figure 8 MN170 1 rev D 13 3 Connecting Focus with the Battery as shown Before using the battery check that it has a sufficient charge The battery s equipped with a gauge Figure 9 to indicate the level of battery charge 25 100 To check the level of charge of the battery press the button on the battery s keypad The battery gauge indicator s LEDs to the left of the button illuminate to indicate the level of battery charge 25 100 Connect the switch end of the battery cord into the Focus unit s power inlet only as shown in Figures 5 and 6 Connect the other end into the battery Do not force the cords as they can be properly inserted only one way Refer to the instructions on charging the battery in the Battery Charging section Focus units Power Inlet BENEH H MTTLLLELIEZIITTETT Belt Shoulder Figure 9 Strap clip Bag with Battery Pockets The Focus with carrying bag Item 1
3. AirBelt power supply provided to charge AirBelt CAUTION MN170 1 rev D 17 turn off The optional AirBelt w ll completely recharge from its fully depleted state in approximately 3 hours While charging a fully discharged battery the LED will continue to blink until 25 capacity is reached The LED will then turn solid Each of the four LEDs 25 100 will blink as stated above then turn solid when the battery reaches it s capacity 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 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 lf 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 is recommended to charge it after each use Depending upon the temperature of the AirBelt it can take several minutes for the charging cycle to start after c
4. Universal AC DC power supply the battery for the Focus unit will display the charge level of the battery 25 to 100 state of charge on the battery gauge indicator s and when at 100 LEDs lights remain on for approximately 15 minutes after reaching a full charge An audible alarm sounds if Focus has a low battery if the cannula is disconnected or if performance of the unit is outside of specifications The light and audible alarm conditions are explained in detail below and summarized on the chart later in this section of the manual e Start Up A brief alarm sounds and the green and red LEDs lights will alternate at start up Focus begins to operate when the alternating LEDs light stop and green LED lights remains on e Low Battery gt Focus unit indicators As the battery power approaches a low level the amber light on the Focus unit will flash on for 12 second with a 5 second pause and simultaneously a Y2 second alarm sounds with a 5 second pause Following the battery warning indicators if action is not taken the unit will shut down This will be indicated when the amber light flashes 2 times with a 5 second pause and simultaneously a 2 second alarm sounds 2 times with a 5 second pause Battery indicator The green light indicator on the battery gauge Figure 9 light illuminates intermittently When either of these conditions occurs connect Focus to a DC power outlet or to an AC power outlet or change to another sourc
5. in the manual MN170 1 rev D 11 Connecting to the Focus Power Inlet Locate the arrow marking at the top of the connector Insert connector Figure 5 into the Focus power inlet Figure 6 with the arrow on the side of the connector facing outward Do not force the connector into the power inlet as it can be inserted only one way This ensures that neither the unit nor the power accessories are damaged Focus unit s Focus unit s power connector power inlet Figure 5 Figure 6 Focus operates from four different power sources NOTE Always connect to the Focus power inlet first before connecting to a power supply 1 Connecting Focus to AC electrical power When you are near an AC outlet you may choose to operate Focus with the universal AC DC power supply rather than the battery Connect the cord on the power supply labeled as DC OUT To Focus into the Focus unit s power inlet as shown in Figure 7 Do not force the plug as it should be inserted only one way From the other end of the power supply connect the 3 prong AC cord from the power supply into any standard outlet Focus unit s dr power inlet by Airsep Dc our To Focus DC Out To bartery DC OUT to Focus Figure 7 MN170 1 rev D 12 2 Connecting Focus to a DC power source The universal power supply can also be used to operate the Focus unit from any 12 Volt DC power source For example to an automobile boat motor home etc w th a
6. outlet immediately Charge battery Connect the Focus unit into aDC outlet or an AC outlet immediately Charge battery Connect the Focus unit into a DC outlet or an AC outlet immediately Charge battery Check the cannula connection Ensure that you are breathing through your nose If the alarm persists contact your Equipment Provider Reduce activity and 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 Equipment Provider Check air inlet and exhaust vents for obstruction Clear obstruction at air inlet and exhaust 25 Cleaning Care and Proper Maintenance Cabinet WARNING WARNING MN170 1 rev D 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 the unit 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
7. the home Focus 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 affect 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 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
8. 20 35619 Braunfels Germany Tel 49 0 6442 962073 E mail info mps gmbh eu Ce 0459 MN170 1 rev D 35 For service on your Focus Portable Oxygen Concentrator please contact your local Equipment Provider at AirSep Corporation AANA I MN170 1 Rev D MN170 1 rev D 36
9. ON 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 diaire de votre fournisseur de materiel Deutsche Eine mehrsprachige Version des Handbuchs ist in Ihrer Gerate Anbieter TABLE OF CONTENTS AirSep Focus Portable Oxygen Concentrator AirSep s Focus Portable Oxygen Concentrator 1 Symbols 1 2 Why Your Physician Prescribed Oxygen 2 3 What is the Focus Portable Oxygen Concentrator 3 Operator Profile 3 Focus for Airline Travel FAA Approved 4 Important Safety Rules 5 10 Getting Started with Your Focus Portable Oxygen Concentrator 11 14 Battery Charging 15 Optional AirBelt Charging the Optional AirBelt 16 18 Nasal Cannula 19 20 Focus Unit Components 20 Operating Instructions 21 Power Supplies Overview 22 TABLE OF CONTENTS AirSep Focus Portable Oxygen Concentrator Audible Alarm and Indicator Lights How to Respond to Focus s Audible Alarm and Indicator Lights Cleaning Care and Proper Maintenance Cabinet Carrying Bag Focus Accessories Materials in direct or indirect contact with the patient Reserve Oxygen Supply Troubleshooting Focus Specifications Classification 23 23 25 26 26 26 27 28 28 28 29 30 33 34 AirSep s Focus Portable Oxygen C
10. Safety Fragile handle with care Keep unit and accessories dry Proper disposal of waste of electrical and electronic equipment required Use no oil or grease Type BF equipment Consult instructions for use FAA Approved POC Do not expose to open flames menschen RTCA DO160 Section 21 Category M This sid Category M Compliant Compliant FAA SFAR 106 man requirement Authorized Representative in the a nen REP European Community Method of disposing of waste All waste from AirSep s Focus Oxygen Concentrator must be disposed of 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 of using the appropriate methods specified by local authorities 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 n 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 Prov
11. assure that it is used in such an electromagnetic environment IEC 60601 TEST Compliance Portable and mobile RF communications equipment should be used no closer Conducted RF 3 Vrms to any part of the Focus including cables than the recommended separation IEC 61000 4 6 150 kHz to 80 MHz an ale 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 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 Q 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 en
12. cal 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 the unit This can cause a malfunction or shut down and cause an increased risk for electrical shock or burns MN170 1 rev D 5 WARNING WARNING WARNING WARNING 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
13. can be placed in the bag with battery pockets Item 10 This will allow you the ability to carry additional battery power in one bag while still operating the Focus The Focus shoulder strap Item 9 can be used with either the Focus in the carrying bag Item 1 or with the Focus with carrying bag Item 1 placed in the Focus bag with battery pockets Item 10 Focus s very light weight and easy to wear using the AirSep supplied shoulder strap Figure 3 or you may clip the battery on either your shoulder strap or belt Focus can be worn on the waist by the Focus bags S Clip to your own waist belt or the optional AirBelt Figure 11 Focus can also be worn over the shoulder with the use of the AirSep supplied shoulder strap as shown Figure 12 3 at Figure 10 Focus unit worn on the waist Figure 11 Focus unit worn with AirBelt Figure 12 Focus unit worn with the shoulder strap MN170 1 rev D 14 Battery Charging Check to make sure your unit s battery s fully charged before venturing out w th Focus for the first time or upon subsequent use To check the level of charge of the battery press the button on the battery s keypad The battery gauge indicator s illuminate to indicate the level of battery charge 25 100 To charge the Focus battery while using Focus la Using AC Power Follow the instructions in the Connecting Focus to AC electrical power section 1b Using DC Power Follow the instructions in the Connecting Focu
14. 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 power to the Oxygen Concentrator MN170 1 rev D 7 N 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
15. e 22 Indicator of Required Inspection Service Dual display Service Required amber MN170 1 rev D 24 How to Respond to Focus s Audible Alarm and Indicator Lights Green and Red hn a Indicator Indicator Alarm Alarm Alarm Alarm Alarm MN170 1 rev D Brief continuous at start up e Battery Intermittent Beep Intermittent Beep beep Continuous Beep Intermittent Beep beep beep Audible alarm sounds beep beep Audible alarm sounds beep beep beep re Green flashes on each breath Amber continuous light 25 Green light flashes Amber alarm intermittent light Amber alarm intermittent light Amber alarm continuous light Amber alarm intermittent light Red light Focus has been turned on Battery charge is low Warning Battery voltage approaching too low a level to continue operating Focus Battery shutdown Battery voltage is too low to operate Focus No breath detected by the unit for a predetermined time period Breathing rate is exceeding the capacity of the Focus unit General malfunction of the Focus unit has occurred You may begin to operate your Focus unit Focus is delivering oxygen Continue using Focus normally as a pulse flow Inspection and or Service Return unit to Equipment Provider required for inspection and or service Connect the Focus unit into aDC outlet or an AC
16. e of oxygen within two minutes The level of battery charge is indicated by the battery gauge indicator s You can also check the state of charge at any time by pressing the button As noted above when the unit is connected to AC or DC power outlet you may simultaneously charge the Focus battery supplied with the unit while using the unit In the event of an alarm or you observe Focus is not working properly consult the Troubleshooting section in this manual If you cannot resolve the problem consult your Equipment Provider WARNING MN170 1 rev D 23 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 e Cannula disconnected When Focus is operating but does not sense breathing for 15 minutes a constant alarm sounds and the amber alarm light illuminates simultaneously If this occurs check the connection from the cannula to the Focus unit make sure that the nasal cannula is positioned properly on your face and ensure that you are breathing through your nose Your physicia
17. er may recommend another source of supplemental oxygen therapy in case there is a mechanical failure or a power outage In the event of an alarm or you observe Focus is not working properly consult the Troubleshooting section in this manual If you cannot resolve the problem consult your Equipment Provider WARNING 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 Troubleshooting The Focus product is designed for years of trouble free use If your Focus 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 Do not attempt any maintenance other than the possible solutions listed below MN170 1 rev D 28 Alarm condition Intermittent Beep beep Amber light illuminates simultaneously and Focus shuts down Alarm condition Intermittent Beep beep beep and the Amber alarm light illuminates simultaneously Unit does not start o
18. gure 19 IN Bi color LED Green light On Pulse Flow Indicator Amber light Alarm and Service Indicator Label Patient Instructions Now that you are familiar with Focus s components review the instructions on the following pages to operate the Focus unit MN170 1 rev D 20 Read the Important Safety Rules section before operating this equipment Operating Instructions 1 Locate and position Focus so that the air inlet and outlet are not obstructed 2 Power the unit from a the battery b DC outlet i e automobile or motor boat or c an AC outlet i e normal household electric Refer to the Power Supplies section of this Patient Manual Refer to Connecting to Focus s Power Inlet section for specific instructions on the connection of power sources 3 Securely connect your cannula to the oxygen outlet as shown in Figure 18 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 WARNING accelerates the combustion of flammable substances 4 Lift the control panel tab on the unit s power inlet and connect the selected power source 1 e battery AC or DC power supply or optional AirBelt 5 Turn the Focus unit on by pressing the power switch to the on position The LEDs on the control panel will illuminate alternating between green and red momentarily A
19. ider who supplies your oxygen equipment will demonstrate how to operate the Focus Portable Oxygen Concentrator MN170 1 rev D 2 What is the Focus Portable Oxygen Concentrator Oxygen concentrators were introduced in the mid 1970s and have become the most convenient reliable source of supplemental oxygen available today Oxygen concentrators are 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 Focus 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 Focus combines advanced oxygen concentrator technology with oxygen conserving technology for the world s smallest and lightest portable oxygen concentrator at just 1 75 Ib 0 8 kg The unit efficiently produces its own oxygen and quickly delivers it as a pulse of oxygen at the very beginning of your inhalation This eliminates the waste associated with a continuous flow oxygen device that delivers oxygen even while you are exhaling Focus produces the equivalent of 2 LPM liters per minute continuous flow oxygen in a lightweight package that patients can wear easily away from
20. isual Battery condition battery level indicator on battery Normal operating 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 Operational Altitude up to 10 000 ft 3 048m 523 mmHg Higher altitudes 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 MN170 1 rev D 30 4 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 Focus is intended for use in the electromagnetic environment specified below The customer or the user of the Focus should assure that it is used in such an environment 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 8kV 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 dipi
21. lluminate to indicate the level of battery charge 25 100 Connect the interface cable Figure 15 into the AirBelt then plug the other end of the interface cable into the Focus as shown in Figure 16 For proper orientation of the connector see Connecting to the Focus Power Inlet section AirBelt battery charge level 25 100 Figure 15 AirBelt to Focus cord AirBelt to Figure 14 Figure 16 Focus l AirBelt battery AirBelt battery connection with Focus MN170 1 rev D 16 Charging the Optional AirBelt To charge the AirBelt battery for extended use 1 Release safety cap from end of the AirBelt cord 2 Connect the Universal AC DC power supply included with AirBelt Accessory kit to the end of AirBelt s power cord as shown in Figure 17 3 Connect the AirBelt power supply to an AC electrical outlet to recharge N Arsen am Connecting the AirBelt cord to the power supply cord _ AC DC Power Supply Figure 17 AirBelt Battery Charging set up For oxygen concentrators equipped with the optional Airbelt 1 The incorrect use of AirBelt can cause the battery to get hot ignite and can cause serious injury Be WARNING sure not to pierce strike step on or drop the battery or otherwise subject the battery to strong impacts or shocks Replace safety cap on AirBelt cord when not in use Do not attempt to charge the optional AirBelt with the Focus power supply or the AirBelt can be damaged Use only the
22. lso each time you turn on Focus a brief alarm sounds This indicates that Focus is powered for use When Focus senses inhalation oxygen is supplied to you through your cannula The time required to reach maximum oxygen concentration after turning on the Focus unit is approximately two minutes 6 To turn Focus off press the power switch to the off position MN170 1 rev D 21 Read the Important Safety Rules section before operating this equipment Power Supplies Overview Focus can be powered in four different ways the battery AC power DC power or an optional AirBelt The Focus power supply functions both as an AC power supply and a DC power supply Refer to Connecting to Focus s Power Inlet section for specific instructions regarding the connection of optional power sources e Battery Two rechargeable batteries are supplied with Focus Each battery when fully charged supplies power to the Focus unit for up to 1 hours An audible alarm sounds when the battery power is getting low The alarm is discussed in the Audible Alarm and Indicator Lights section of this manual The 25 capacity LED will blink every 2 second to indicate a low state of charge when the button is pressed During this condition change to another battery or alternate power source Battery Charging Battery Charging section To charge the battery connect the battery to either the power supply and a 100 240 volt 50 60 Hz AC power outlet
23. lt with Power Supply including the following power cords as applicable AirBelt with Power Supply BT017 extended cord length 4 ft 1 2m w CD023 2 Power Cord 120VAC 8 ft 2 4m AirBelt with Power Supply BT017 extended cord length 4 ft 1 2m w CD017 2 Euro Power Cord 8 ft 2 in 2 5m AirBelt with Power Supply 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 BT017 extended cord length 4 ft 1 2m w CD017 4 UK Power Cord 8 ft 2 in 2 5m Cord for connecting AirBelt to Focus AirBelt to Focus cord with On Off switch 8in 203 2mm 27 Materials in direct or indirect contact with the patient o Concentrator casing Valtra ABS Polystyrene o Concentrator Control Panel Nitrile Rubber SGaS Que lit een Delrin o ON OFF Power Switch Thermoplastic SUN Labels sine Lexan GCOC ee Polyurethane o Cord connectors ccceeeeeees Polycarbonate Vinyl chloride OCOL SWICK A ee Nylon o Power SUPPIV iss fcr dt cew seed enw esedeneeeet Lexan 940 Polycarbonate Battery PACK ss tuetieseodieaceasennteewacened Lexan 945 o Battery Pack Power Supply Labels Polyester film o Concentrator carrying case 100 Polyester microfiber w PCV backing o Power Supply Battery carrying case Belt and Strap 100 Polyester microfiber w PVC backing Reserve Oxygen Supply Your Equipment Provid
24. main within a temperature range of 73 F 35 F 23 C 2 C 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 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 Nasal cannula must be non kinking which can be used for a total length of up to 25 ft 7 6 m maximum 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 MN170 1 rev D 9 AirSep offers the OxySafe as an optional accessory This is intended to be used in conjunction with the Focus concentrator For customers in regions requiring compliance to EN ISO 8359 1996 Ammendment1 2012 this accessory will meet this need The Ox
25. moval of the battery from the device for all international airline travel when the oxygen concentrator is checked as luggage When shipping the oxygen concentrator the battery must also be removed from the device and packaged properly MN170 1 rev D 8 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 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 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 re
26. n may recommend the use of a chin strap if needed If the alarm condition continues change to another source of oxygen as available and contact your Equipment Provider e Focus s capacity is exceeded If your breathing rate causes the capacity of Focus to be exceeded an alarm sounds 3 times every 2 second with a 5 second pause and the amber alarm light illuminates simultaneously You should reduce any physical activity reset alarm by turning unit off and back on and then if necessary change to another source of oxygen as available and contact your Equipment Provider e General malfunction A general malfunction may be one of the following 1 An audible alarm sounds beep beep and the red alarm light illuminates If this alarm condition occurs change to another source of oxygen as available and contact your Equipment Provider 2 An audible alarm sounds beep beep beep and the red alarm light illuminates If this alarm occurs check air inlet and exhaust vents for obstruction Clear obstruction at air inlet and exhaust e Service light If the Focus unit s normally green light changes to solid amber with no audible alarm contact your Equipment Provider When the service indicator illuminates solid amber it is time for your Focus unit to be inspected and or serviced by your Equipment Provider After any necessary service and the performance is verified by the Equipment Provider the service indicator light will be reset Figur
27. n Ur for 5 cycles 70 Ur 30 dipin Ur for 25 cycles lt 5 Ur gt 95 dipin Ur for 5s 6 kV contact 8kV air 2 kV for power supply lines Not Applicable 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 30 dipin Ur for 25 cycles lt 5 Ur gt 95 dipin Ur for5s NOTE Uy is the a c mains voltage prior to application of the test level MN170 1 rev D IEC 60601 Electromagnetic environment 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 Ifthe user ofthe Focus requires continued operation during power mains interruptions it is recommended that the Focus 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 31 Guidance and manufacturer s declaration electromagnetic immunity The Focus is intended for use in the electromagnetic environment specified below The customer or the user of the Focus should
28. n battery power although the battery indicates a charge Delay in recharging battery Unit alarms does not start in automobile while connected to a properly functioning DC outlet Alarm condition Audible alarm sounds beep beep and Red alarm light illuminates OR Alarm condition Audible alarm sounds beep beep beep and Red alarm light illuminates All other problems MN170 1 rev D Battery voltage is too low to operate the Focus unit Breathing rate has exceeded the capacity of the Focus unit Battery may be hot too or cold if left outdoors such as in an automobile Battery exceeds charging temperature Focus power supply needs resetting A general malfunction has occurred 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 Allow the battery to reach normal operating temperature which may take several minutes if exposed to temperature extremes Temporarily connect your AC or DC power supply to the unit s power inlet and power source as needed Unit may be operated however charging may not resume until battery temperature is reduced Turn off unit Disconnect the DC power supply from the automobile outlet restart the automobile and then reconnect the DC power supply into the automobile DC outlet to reset the DC power
29. ng 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 Focus is intended for use in the electromagnetic environment specified below The customer or the user of the Focus should assure that it is used in such an environment Wer The Focus uses RF energy only for its internal function Therefore its RF emissions are RF emissions Groupi very low and are not likely to cause any interference in nearby electronic equipment CISPR 11 RF emissions The Focus 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 MN170 1 rev D 33 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 curren
30. oncentrator This Patient Manual will acquaint you with AirSep s Focus Portable Oxygen Concentrator POC Make sure you read and understand all the information contained in this manual before you operate your Focus 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 Focus Portable Oxygen Concentrator Description Symbol Description OO POET ENCE EN OFF power switch off severe bodily injury death or property damage Caution Describes a hazard or unsafe Complies with the 93 42 EEC directive practice that if not avoided can result in drawn up by the approved organization minor bodily injury or property damage 0459 No 0459 Warning Describes a hazard or unsafe practice that if not avoided can result in Class II Equipment double insulated Note Provides information important PS Safety agency for CAN CSA C22 2 No enough to emphasize or repeat 2 60601 1 08 M90 for medical electrical equipment Consult the accompanying See Instructions documents Catalog Number el Date of Manufacture MN170 1 rev D 1 Certified Electrical
31. onnecting to power This is a normal condition and is intended for safe charging For oxygen concentrators equipped with the optional Airbelt 1 MN170 1 rev D f the AirBelt power supply remains connected when AirBelt is fully charged the four LEDs will turn off within 15 minutes 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 18 Read the Important Safety Rules section before operating this equipment Nasal Cannula A nasal cannula with tubing are used to deliver oxygen from the Focus unit to the user The tubing is connected to the unit s oxygen outlet See Figure 18 Focus Power Inlet Connect the Cannula to Focus s Oxygen Outlet Figure 18 AirSep recommends a nasal cannula with 7 ft 2 1 m of tubing AirSep Part No CU002 1 or other suitable cannula Other lengths of non kinking star channel cannula can be used for a total length of up to 25 ft 7 6 m maximum When Focus is operating but does not sense breathing for 15 minutes a constant alarm sounds and the amber alarm light illuminates simultaneously If this occurs check the connection from the cannula to the Focus unit make sure that the nasal cannula is positioned properly on your face and ensure that y
32. or connect the power supply to a DC power outlet in an automobile boat motor home etc A discharged battery requires approximately four hours to fully charge It is recommended to recharge the battery even if only partially depleted as often as possible e Universal Power Supply The AC power supply side of the universal power supply allows the Focus unit to connect to a 100 240 volt 50 60 Hz outlet The power supply converts 100 240 volt AC to a DC voltage for the Focus unit to operate while recharging the Focus battery simultaneously The DC power inlet on the universal power supply allows the Focus unit to connect to a motor vehicle s 12 Volt DC outlet for the Focus unit to operate while recharging Focus s battery simultaneously e Optional AirBelt Focus can also be powered with AirBelt AirBelt can be worn around the waist When fully charged the battery supplies power to Focus for up to 4 hours AirBelt connects to the Focus unit s power inlet It can be recharged by connecting it only to the AirBelt AC power supply MN170 1 rev D 22 Read the Important Safety Rules section before operating this equipment Audible Alarm and Indicator Lights When the Focus unit senses inhalation a pulse of oxygen is delivered through the nasal cannula The green light on the unit s control panel blinks each time a breath is detected Additionally when the unit is operating and the battery is simultaneously being charged through the
33. ou are breathing through your nose Your physician may recommend the use of a chin strap if needed If the alarm condition continues change to another source of oxygen as available and contact your Equipment Provider 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 Additional supplies are available from your Equipment Provider Cannula tubing must be non kinking which can be used for a total length of up to 25 ft 7 6 m maximum MN170 1 rev D 19 Focus Unit Components Focus Power Inlet Air Outlet Air Inlet Figure 20 Focus Exterior View Front Focus Control Panel Top view Alarm Display and Power Inlet Alarm Indicator AIRSEP CORPORATION SURIER 401 CREEXSIDE ORME BUFFALO NEW YORK 14228 USA MODEL ASO78 FOCUS Oxygen Concentrator 15 VOC 1 55 cat MN SEE INSTRUCTIONS No smokin pen flames are allowed within 5 feet of g or open 1 this device or 2 any oxygen carrying accessory Ss Use no oll of grease CA Do not disassemble or heat above 60 C Keep Dry 5 feet Figure 21 Focus Exterior View Back Fi
34. 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 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 The Manufacturer does not recommend the sterilization of this equipment To prevent a void warranty follow all manufacturers instructions 26 Carrying Bag Battery Case Belt and Strap To clean the carrying bag battery case belt and strap brush only with warm soapy water do not saturate then allow to air dry Do not machine wash or dry Focus Accessories For proper performance and safety u
35. r le WARNING 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 Cet appareil produit de l oxyg ne a concentration lev e favorisant une combustion rapide Ne pas permettre de 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
36. r oxygen concentrators equipped with the optional Airbelt 1 The AirBelt does not need to be fully discharged before recharging It is recommended to charge it after each use 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 MN170 1 rev D 10 Read the Important Safety Rules section before operating this equipment Getting Started with Your Focus Portable Oxygen Concentrator The Focus packaging contains the following items as shown below If any items are missing contact your Equipment Provider 1 2 3 4 5 6 5 9 10 Bag W Battery Pockets 11 Patient Manual not shown gt Q Figure 2 Focus Power Supply with DC Input Cord and adapter ome ISA Focus unit with carrying bag Coil Cord w Switch connects battery to Focus Battery Pack Lithium Ion Rechargable 2 supplied Battery case Universal Power Supply AC DC AC Power Cord DC Power Cord Coil Cord without switch connects battery to power supply charger to battery Focus shoulder strap i 22 da OO On Ai Figure 1 Focus with battery Figure 3 Focus shoulder strap Figure 4 Bag W Battery Pockets Before operating Focus for the first time familiarize yourself with the major components These are illustrated in the Figures on the following pages and discussed later
37. rying 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 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 electri
38. s with the Battery_section 2 Connect the coiled battery cord no on off switch into the Universal AC DC power supply outlet labeled DC OUT To Battery Connect the other end to the battery Note The battery 1s charging whenever the unit operates on AC or DC power e The Focus battery will completely recharge from its fully depleted state in approximately 4 hours whether the unit is in use on AC or on DC power e While charging a fully discharged battery 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 the battery reaches it s 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 N DC OUT To Battery DC OUT to Focus m by AirSep 0 Focus CD032 2 Cord for recharging only no on off switch Figure 13 MN170 1 rev D 15 Optional AirBelt Optionally you may also have an AirBelt for extended use of Focus The optional AirBelt Figure 14 can power the Focus unit for up to 4 hours Before using AirBelt check that it is sufficiently charged It requires approximately 3 hours to completely charge AirBelt 1s equipped with a battery gauge indicator to indicate the level of battery charge 25 100 To check the level of charge press the button on the AirBelt keypad The battery gauge indicator s i
39. se 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 Focus Portable Oxygen Concentrator MI332 1 includes BT023 1 CD034 1 CD032 1 CD032 2 PW023 1 2 3 or 4 BT017 1 2 3 or 4 CD035 1 MI333 1 MI379 1 MI380 1 MI345 1 PW023 1 PW023 2 PW023 3 PW023 4 BT017 1 BT017 2 BT017 3 BT017 4 MN170 1 rev D Focus Bag Set includes the following Battery Case Focus Bag W Battery Pockets Shoulder Strap Focus Carrying Bag Focus Lithium lon battery pack 2 supplied DC power cord 33in 860mm Battery to Focus cord with On Off Switch 18in 456mm Battery to Power Supply cord only for charging battery 18in 456mm 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 120V 8ft 2 4m and CD034 1DC power cord 33in 860mm Universal AC DC Power Supply 4ft 1 2m w CD017 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 AirBe
40. skills or user abilities required for concentrator use MN170 1 rev D 3 Focus for Airline Travel FAA Approved Focus has received the US Federal Aviation Administration s FAA acceptance for onboard in flight use by oxygen passengers on commercial airlines via a 2012 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 MN170 1 rev D 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 Focus Oxygen Concentrator WARNING 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 car
41. spose 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 MN170 1 rev D 6 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 Y damage or injury If the oxygen concentrator has been dropped damaged or exposed to water please contact your home care WARNING provider for inspection or possible repair of the device Do not use the oxygen concentrator if it has a damaged power cord or plug 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 connecte
42. supply Turn off unit Change to another source of oxygen as available and contact your Equipment Provider Check air inlet and exhaust vents for obstruction Clear obstruction at air inlet and exhaust Turn off unit Change to another source of oxygen as available and contact your Equipment Provider 29 Focus Specifications Oxygen Concentration Pulse Dose Dimensions Weight Power Battery duration Rechargeable lithium Battery Battery recharge time Warm up time Battery cycle life Audible alarms and pulse visual indicators Temperature range Operational Altitude Pulse setting equivalent to a continuous flow of 90 oxygen 3 5 5 17 25ml 10 6 4 in high x 4 8 in wide x 2 5 in deep 16 4 cm high x 12 2 cm wide x 6 1 deep Concentrator 1 75 Ib 0 8 kg Battery 0 53 Ib 0 2 kg Optional AirBelt Battery 1 8 Ib 0 8 kg Universal Power Supply AC Power Supply Input 1_100 240 VAC 1 5 Amps max at 120 VAC 50 60 Hz DC Power Supply Input 2_11 16 VDC 5 0 Amps max Battery 1 hours per battery Optional AirBelt Battery 4 hours 4 hours optional AirBelt 3 hours 2 minutes Approximately 300 cycles then 80 capacity or below Start up audible and visual Pulse flow visual Cannula disconnect audible and visual Breath rate alarm audible and visual General malfunction audible and visual Service required visual Low battery audible and v
43. t 2 reliability of protective earth connection if present Not intended for direct cardiac application Independent testing for Medical Electrical Equipment Standard Tested by QPS Testing Services NA Inc to be in compliance with IEC 60601 1 Medical Electrical Equipment Part 1 General Requirements for Safety Tested by QPS to be in compliance with applicable requirements of the Standard 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 by Ultratech Group of Labs to be in compliance with EN 60601 1 2 Medical Electrical Equipment Part 1 General Requirements for Safety Collateral Standard Electrical Compatibility Requirements and Tests RTCA DO160 Airborne Equipment Sec 21 Emission of Radio Frequency Energy 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 Focus 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 MN170 1 rev D 34 For European Representative Medical Product Services GmbH MPS Borngasse
44. 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 the 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 re
45. 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 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 di
46. vironment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the Focus is used exceeds the applicable RF compliance level above the Focus should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as re orienting or relocating the Focus b Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m MN170 1 rev D 32 Recommended separation distances between portable and mobile RF communications equipment and the Focus The Focus is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the Focus can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the Focus as recommended below according to the maximum output power of the communications equipment Separation distance according to frequency of transmitter Rated maximum output m from 150kHz to 80MHz from 80MHz to 800MHz from 800MHz to 2 5GHz d 1 2 x VP d 1 2 x P d 2 3 x P power of transmitter 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 rati
47. ySafe 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 placed in line with the nasal cannula or oxygen tubing between the patient and the oxygen outlet of the Visionaire For proper use of the 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 2062967 1 Important Safety Rules for Optional AirBelt For oxygen concentrators equipped with the optional Airbelt 1 The incorrect use of AirBelt can cause the battery to get hot ignite and can cause serious injury Be sure not to pierce strike step on or drop the battery or otherwise subject the battery to strong impacts WARNING or shocks Replace safety cap on AirBelt cord when not in use For oxygen concentrators equipped with batteries 1 When connected to AC or DC power the units 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 Fo
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