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Freestyle Comfort Manual

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FreeStyle Comfort User Manual English AMSR oxygenconcentratorstore com 1 877 774 9271

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FreeStyle Comfort User Controls System Status Indicators ISO 7000 Graphical symbols for use on equipment Index and synopsis Read user s manual before operation Reg 1641 Operating temperature limitation of these units is 41 F to 104 F 5 C to 40 C Storage temperature limitation range is 13 F to 158 F 25 C to 70 C Reg 0632 Council Directive 93 42 EEC concerning medical devices Authorized representative in the European Community This device complies with the requirements of Directive 93 42 EEC concerning medical devices It bears the CE marking as shown IEC 60417 Humidity range is 10 to 95 Reg 2620 Class II Equipment Double Insulated Reg 5172 Atmospheric pressure limitation Reg 2621 Power switch Reg 5009 Name and address of manufacturer Reg 3082 ETL Certification Safety agency for CAN CSA C22 2 No 601 1 M90 for medical electrical equipment Date of manufacturer Reg 2497 Catalog Number Reg 2493 Internal Symbols Keep away from flammable materials oil and grease Serial Number Reg 2498 This way up Reg 0623 Do not disassemble Fragile handle with care Reg 0621 Increase flow Keep away from rain keep dry Reg 0626 Stacking limit by number Reg 2403 ISO 7010 Graphical symbols Safety colors and safety signs Registered safety signs The instruction manual must be read Reg M002 Keep away from open flame fire sparks Open ignition source and smoking prohibited Reg P003 Do not smoke near unit or while operating unit Reg P002 Type BF applied part degree of protection against electric shock Reg 5333 Decrease flow RTCA DO160 Section 21 Category M Compliant RTCA DO160 Section 21 Category M Compliant FAA SFAR 106 requirement Class II Equipment Double Insulated FAA Approved POC 21 CFR 801 15 Code of Federal Regulations Title 21 Federal law restricts this device to sale by or on the order of a physician Warning Reg W001 2 ENG PN MN232 C User Manual AMSR oxygenconcentratorstore com 1 877 774 9271

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FreeStyle Comfort Council Directive 2012 19 EU waste electrical and electronic equipment WEEE IEC 60601 1 Medical electrical equipment Part 1 General requirements for basic safety and essential performance WEEE Drip Proof This product may be covered by one or more patents US and international Please visit our website below for the listing of applicable patents Pat patents gtls io What is the Oxygen Concentrator The air we breathe contains approximately 21 oxygen 78 nitrogen and 1 other gasses In the FreeStyle Comfort room air is drawn into the machine through the air intakes It then passes through an adsorbent material called molecular sieve This material separates the oxygen from the nitrogen and allows only the oxygen to pass through The result is a flow of high concentration oxygen delivered to the user The FreeStyle Comfort combines advanced oxygen concentrator and oxygen conserving technologies to create a portable device that allows for maximum portability and ambulation The advanced pulse flow delivery quickly senses when the user breathes in and delivers a pulse of oxygen at the beginning of each inhalation Pulse flow delivery is ideal for activities and time away from home It conserves oxygen and extends battery life as opposed to continuous flow The FreeStyle Comfort is lightweight enough to be carried via handle shoulder strap or backpack It can be operated on AC DC vehicle or battery power Why Your Physician Prescribed Oxygen Many people suffer from a variety of heart lung and other respiratory diseases A significant number of these people can benefit from supplemental oxygen therapy at home when traveling or while participating in daily activities away from home Oxygen is a gas that makes up 21 of the ambient air we breathe and our bodies depend on a steady supply to function properly Your physician prescribed a flow or setting to address your particular respiratory condition Although oxygen is a non addictive drug unauthorized oxygen therapy can be dangerous You must seek medical advice before you use this oxygen concentrator The Equipment Provider who supplies your oxygen equipment will demonstrate how to set the prescribed flow rate Operator Profile Concentrators are intended to supply supplemental oxygen to users suffering from discomfort due to ailments which effect the efficiency of one s lungs to transfer oxygen in the air to their bloodstream Portable oxygen concentrators POCs do not store or contain oxygen They do not need to be refilled and can recharge anywhere AC or DC power is available except on an airplane This 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 users of all ages the typical oxygen therapy user is older than 65 years of age and suffers from a variety of respiratory diseases including Chronic Obstructive Pulmonary Disorder COPD Users 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 users are advised to contact their healthcare provider Users 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 PN MN232 C User Manual AMSR oxygenconcentratorstore com ENG 3 1 877 774 9271

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FreeStyle Comfort Unpacking Your FreeStyle Comfort Verify that all of the components listed are included in the package If any items are missing contact your oxygen provider immediately Standard Accessories Portable Oxygen Concentrator Carrying Bag Shoulder Strap 8 Cell Battery Pack AC Power Supply AC Power Cord DC Power Supply User Manual Optional Accessories Additional 8 Cell Battery Pack 16 Cell Battery Pack Desktop Charger Carry all Accessory Bag Getting to Know Your FreeStyle Comfort Become familiar with the key features of the FreeStyle Comfort and its user interface Front View User Interface Strap Attachment Oxygen Outlet Air Outlet Air Intake Filters Air Intake Filters Power Port Receptacle Tab Battery Pack Battery Pack Release Button 4 ENG PN MN232 C User Manual AMSR oxygenconcentratorstore com 1 877 774 9271

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FreeStyle Comfort Top View Display Screen Increase Flow Power Button Decrease Flow Display Screen On Battery Battery Display Flow Setting Battery Percentage Remaining Alarm Display Space Display Screen On AC DC Power Flow Setting Battery Display Alarm Display Space Charge Indicator PN MN232 C User Manual AMSR oxygenconcentratorstore com ENG 5 1 877 774 9271

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FreeStyle Comfort Important Contraindications for Use Safety Instructions are defined as follows WARNING IMPORTANT SAFETY INFORMATION FOR HAZARDS THAT MIGHT CAUSE SERIOUS INJURY CAUTION Important information for preventing damage to the FreeStyle Comfort Note Information needing special attention Indications for Use WARNING 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 WARNING FEDERAL USA LAW RESTRICTS THIS DEVICE TO SALE OR RENTAL BY ORDER OF A PHYSICIAN OR OTHER LICENSED HEALTH CARE PROVIDER WARNING IN CERTAIN CIRCUMSTANCES THE USE OF NON PRESCRIBED OXYGEN CAN BE HAZARDOUS THIS DEVICE SHOULD ONLY BE USED WHEN PRESCRIBED BY A PHYSICIAN WARNING NOT FOR USE IN THE PRESENCE OF FLAMMABLE ANESTHETICS WARNING AS WITH ANY ELECTRICALLY POWERED DEVICE THE USER MAY EXPERIENCE PERIODS OF NON OPERATION AS A RESULT 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 USER WHO WOULD EXPERIENCE ADVERSE HEALTH CONSEQUENCES AS THE RESULT OF SUCH TEMPORARY INTERRUPTION Safety Guidelines WARNING NO MODIFICATION OF THIS EQUIPMENT IS PERMITTED WARNING THIS UNIT IS NOT TO BE USED FOR LIFE SUPPORT GERIATRIC PEDIATRIC OR ANY OTHER USER UNABLE TO COMMUNICATE DISCOMFORT WHILE USING THIS DEVICE MAY REQUIRE ADDITIONAL MONITORING USERS WITH HEARING AND OR SIGHT IMPAIRMENT S MAY NEED ASSISTANCE WITH MONITORING ALARMS WARNING THIS DEVICE SUPPLIES HIGH CONCENTRATION OXYGEN THAT PROMOTES RAPID BURNING DO NOT ALLOW SMOKING OR OPEN FLAMES WITHIN THE SAME ROOM OF 1 THIS DEVICE OR 2 ANY OXYGEN CARRYING ACCESSORY FAILURE TO OBSERVE THIS WARNING CAN RESULT IN SEVERE FIRE PROPERTY DAMAGE AND OR CAUSE PHYSICAL INJURY OR DEATH WARNING PULSE DOSE MODE SETTINGS MUST BE DETERMINED FOR EACH USER INDIVIDUALLY FOR THEIR NEEDS AT REST DURING EXERCISE AND WHEN TRAVELING WARNING 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 WARNING SOME RESPIRATORY EFFORTS OF THE PATIENT MIGHT NOT TRIGGER THE CONSERVING FUNCTION WARNING THE FREESTYLE COMFORT IS NOT INTENDED FOR USE WITH A TRACHEOTOMISED PATIENT WARNING THE CONCENTRATOR SHOULD BE LOCATED AS TO AVOID SMOKE POLLUTANTS OR FUMES WARNING PREGNANT OR NURSING WOMEN SHOULD NOT USE ACCESSORIES RECOMMENDED IN THIS MANUAL THEY MAY CONTAIN PHTHALATES 6 ENG PN MN232 C User Manual AMSR oxygenconcentratorstore com 1 877 774 9271

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FreeStyle Comfort WARNING THE USE OF SOME OXYGEN ADMINISTRATING ACCESSORIES NOT SPECIFIED FOR THIS OXYGEN CONCENTRATOR MAY IMPAIR ITS PERFORMANCE RECOMMENDED ACCESSORIES ARE REFERENCED WITHIN THIS MANUAL WARNING IF THE OXYGEN CONCENTRATOR HAS BEEN DROPPED DAMAGED OR EXPOSED TO WATER PLEASE CONTACT YOUR HOME CARE PROVIDER FOR INSPECTION OR POSSIBLE REPAIR OF THE DEVICE DO NOT USE THE OXYGEN CONCENTRATOR IF IT HAS A DAMAGED POWER CORD OR PLUG WARNING PROPERLY SECURE BELT OR OTHERWISE RESTRAIN THE OXYGEN CONCENTRATOR WHEN IN A VEHICLE DURING TRANSPORT TO PREVENT DAMAGE OR INJURY WARNING THE US DEPARTMENT OF TRANSPORTATION DOT AND UNITED NATIONS UN REGULATIONS REQUIRE THE REMOVAL OF THE BATTERY FROM THE DEVICE FOR ALL INTERNATIONAL AIRLINE TRAVEL 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 WARNING DO NOT OPERATE THIS EQUIPMENT WITHOUT FIRST READING AND UNDERSTANDING THIS MANUAL IF YOU ARE UNABLE TO UNDERSTAND THE WARNINGS AND INSTRUCTIONS CONTACT YOUR EQUIPMENT PROVIDER BEFORE ATTEMPTING TO USE THIS EQUIPMENT OTHERWISE INJURY OR DAMAGE MAY RESULT WARNING IF YOU FEEL DISCOMFORT OR ARE EXPERIENCING A MEDICAL EMERGENCY SEEK MEDICAL ASSISTANCE IMMEDIATELY WARNING OPERATING THE OXYGEN CONCENTRATOR OUTSIDE OF THE OPERATIONAL TEMPERATURE SPECIFICATIONS CAN LIMIT THE CONCENTRATOR S ABILITY TO MEET OXYGEN CONCENTRATION SPECIFICATION REFER TO THE SPECIFICATION SECTION OF THIS MANUAL FOR TEMPERATURE LIMITS WARNING 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 WARNING DO NOT ALLOW EITHER THE AIR INTAKE OR THE AIR OUTLET EXHAUST 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 WARNING 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 WARNING 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 WARNING WHILE USING THE PORTABLE OXYGEN CONCENTRATOR OUTDOORS WITH THE AC POWER SUPPLY CONNECT THE POWER SUPPLY INTO A GROUND FAULT INTERRUPTED GFI OUTLET ONLY WARNING THE OXYGEN CONCENTRATOR SHOULD NOT BE USED ADJACENT TO OR STACKED WITH OTHER EQUIPMENT IF ADJACENT OR STACKED USE IS UNAVOIDABLE THE DEVICE SHOULD BE OBSERVED TO VERIFY NORMAL OPERATION WARNING 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 WARNING USE ONLY ELECTRICAL VOLTAGE SPECIFIED ON THE SPECIFICATION LABEL AFFIXED TO THE DEVICE WARNING 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 PN MN232 C User Manual AMSR oxygenconcentratorstore com ENG 7 1 877 774 9271

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FreeStyle Comfort CAUTION 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 WARNING NO SMOKING OXYGEN IN USE SIGNS MUST BE PROMINENTLY DISPLAYED IN THE HOME OR WHERE OXYGEN IS IN USE USERS AND THEIR CAREGIVERS MUST BE INFORMED ABOUT THE DANGERS OF SMOKING IN THE PRESENCE OF OR WHILE USING MEDICAL OXYGEN CAUTION To prevent a void warranty follow all manufacturers instructions WARNING DO NOT USE YOUR OXYGEN CONCENTRATOR IN THE PRESENCE OF FLAMMABLE GASES THIS CAN RESULT IN RAPID BURNING CAUSING PROPERTY DAMAGE BODILY INJURIES OR DEATH WARNING 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 WARNING ONLY ACCESSORIES RECOMMENDED BY THE MANUFACTURER USE OF ANY OTHER MAY BE HAZARDOUS CAUSE SERIOUS DAMAGE TO YOUR OXYGEN CONCENTRATOR AND WILL VOID THE WARRANTY WARNING 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 WARNING 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 WARNING 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 WARNING SMOKING WHILE WEARING AN OXYGEN CANNULA MAY CAUSE FACIAL BURNS AND POSSIBLY DEATH WARNING IF YOU SMOKE THESE 3 STEPS MAY SAVE YOUR LIFE TURN OFF THE OXYGEN CONCENTRATOR TAKE OFF THE CANNULA AND LEAVE THE ROOM WHERE THIS DEVICE IS LOCATED 8 ENG WARNING REMOVING THE CANNULA AND PUTTING IT ON CLOTHING BEDDING SOFAS OR OTHER CUSHION MATERIAL WILL CAUSE A FLASH FIRE WHEN EXPOSED TO A CIGARETTE HEAT SOURCE OR FLAME WARNING DO NOT LEAVE A NASAL CANNULA ON OR UNDER CLOTHING BED COVERINGS OR CHAIR CUSHIONS IF THE UNIT IS TURNED ON BUT NOT IN USE THE OXYGEN WILL MAKE THE MATERIAL FLAMMABLE ENSURE THE POWER IS OFF WHEN THE OXYGEN CONCENTRATOR IS NOT IN USE WARNING THE OXYGEN CONCENTRATOR MUST BE OFF AND DISCONNECTED FROM EXTERNAL POWER BEFORE REMOVING THE BATTERY PACK WARNING SMALL PARTS MAY PRESENT A POTENTIAL CHOKING HAZARD WARNING AVOID CONTACT WITH EXHAUST AIR VENT FOR LONGER THAN 10 SECONDS AS IT MAY BE WARM WARNING WIND OR STRONG DRAUGHTS CAN ADVERSELY AFFECT ACCURATE DELIVERY OF OXYGEN THERAPY CAUTION Always disconnect AC power supply from the wall before disconnecting the AC power supply from the Oxygen Concentrator CAUTION Do not position the Oxygen Concentrator so that it is difficult to access the power cord CAUTION Always place oxygen supply tubing and power cords in a manner that prevents trip hazard or possible accidental strangulation PN MN232 C User Manual AMSR oxygenconcentratorstore com 1 877 774 9271

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FreeStyle Comfort CAUTION 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 Failure to follow these instructions can result in the power supply not supplying power to the Oxygen Concentrator 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 Note Portable and mobile RF communications equipment can effect medical electrical equipment CAUTION 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 CAUTION Operating or storing the Oxygen Concentrator outside of its normal operating temperature range and ambient pressure range altitude 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 CAUTION 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 CAUTION ONLY USE the Manufacturer s provided batteries For proper battery disposal contact your Equipment Provider or your local government agency for disposal requirements Note 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 Note 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 4 F 68 F 20 C 20 C Note 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 Note 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 Note The Manufacturer does not recommend the sterilization of this equipment Note There is never a danger of depleting the oxygen in a room when you use your oxygen concentrator unit WARNING THE OXYGEN CONCENTRATOR SHOULD NOT BE OPERATED OR PLUGGED IN TO EXTERNAL AC DC POWER WITHOUT A BATTERY INSTALLED DO NOT ATTEMPT TO POWER ON THE UNIT OR CONNECT IT TO EXTERNAL POWER WHEN THE BATTERY PACK IS REMOVED ONLY REMOVE THE BATTERY PACK WHEN THE UNIT IS POWERED OFF AND UNPLUGGED FROM THE POWER SUPPLY DO NOT ATTEMPT TO REMOVE THE BATTERY PACK WHILE THE UNIT IS STILL ON OR PLUGGED INTO THE POWER SUPPLY Note If the oxygen concentrator has been stored for an extended period of time outside of its normal environmental operating conditions shown in the table above it should be allowed to return to normal operating temperature before being powered on PN MN232 C User Manual AMSR oxygenconcentratorstore com ENG 9 1 877 774 9271

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FreeStyle Comfort Specifications FreeStyle Comfort Dimensions with Single Battery 10 0 x 7 3 x 3 1 in 25 4 x 18 5 x 7 9 cm Dimensions with Double Battery 11 0 x 7 3 x 3 1 in 27 9 x 18 5 x 7 9 cm Weight with Single Battery Pack 5 lbs 2 3 kg Weight with Double Battery Pack 6 lbs 2 7 kg Nominal Sound Level 43 dbA 2 Flow Settings Pulse Setting 1 2 3 4 5 O2 Output Setting Setting 1 210 mL min Setting 2 420 mL min Setting 3 630 mL min Setting 4 840 mL min Setting 5 1050 mL min Oxygen Concentration Oxygen Monitor Maximum Outlet Pressure Dosing Sensitivity 90 5 5 3 Yes

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FreeStyle Comfort Operating Instructions 1 Locate and position the FreeStyle Comfort in a proper location for use a The concentrator should be well ventilated so that the air intake filters and air outlet are not obstructed b The concentrator should be positioned so that all audible and visual indicators and alarms can be easily seen and heard c Be sure the air intake filters are in place before operating the unit If the unit is missing a filter contact your equipment provider 2 Install a Battery Pack in the concentrator a Align the battery with the bottom housing from the center of the FreeStyle Comfort 3 Insert the AC or DC power supply into the power port receptacle on the front bottom right side of the unit 4 Connect a nasal cannula to the oxygen outlet barb Ensure the connection is secure before operation NOTE Any cannula s used other than the recommended may affect performance b Slide the battery inward until you hear a click to confirm that it has locked in place Note To Equipment Provider The following oxygen administration accessories are recommended for use with the Oxygen Concentrator Nasal Cannula with 7 feet 2 1 m of tubing 1 to 6 LPM PN 5408 SEQ For any additional recommended accessories please see the Accessories Catalog PN MLLOX0010 available on www CAIREmedical com A firebreak is required for use with any cannula CAIRE offers the OxySafe This is intended to be used in conjunction with the oxygen concentrator The OxySafe is a thermal fuse to stop the flow of gas in the event that the downstream cannula or oxygen tubing is ignited and burns to the OxySafe It is placed in line with the nasal cannula or oxygen tubing between the patient and the oxygen outlet of the FreeStyle Comfort For proper use of the OxySafe always refer to the manufacturer s instructions included with each OxySafe kit CAIRE offers an OxySafe kit that includes a cannula headpiece OxySafe and 7 tubing PN 20629671 PN MN232 C User Manual AMSR oxygenconcentratorstore com ENG 11 1 877 774 9271

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FreeStyle Comfort 5 Turn on the FreeStyle Comfort by pressing the power button and select your prescribed flow setting utilizing the increase or decrease flow buttons A brief audible alarm will sound to indicate the device has powered on Note When the FreeStyle Comfort is initially turned on the default flow setting is 2 If the setting is changed the unit will power on to the previous flow setting 6 Position the nasal cannula on your face per the manufacturer s instructions provided with the cannula and breathe normally You should feel a puff of oxygen delivered through the nasal cannula each time you inhale Pulse Volume mL Setting Breath Rate 1 2 3 4 5 15 14 28 42 56 70 20 10 5 21 31 5 42 52 5 25 8 4 16 8 25 2 33 6 42 30 7 14 21 28 35 35 6 12 18 24 30 40 5 3 10 5 15 8 21 26 3 Tolerance is 15 8 Turn the FreeStyle Comfort off by pressing the power button Note The display screen will enter standby mode and dim after 20 seconds Press any button to wake the screen out of standby mode 7 To change the flow setting press the increase or decrease flow buttons to the desired flow rate It is normal to hear a difference in sound as you change the flow settings 12 ENG PN MN232 C User Manual AMSR oxygenconcentratorstore com 1 877 774 9271

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FreeStyle Comfort REMOVING THE BATTERY Power Supplies The FreeStyle Comfort can be powered in 3 ways Rechargeable Battery Pack AC Power DC Power Information on the operation of each of these components is in the following sections WARNING USE ONLY THE POWER SUPPLIES OUTLINED IN THIS USER S MANUAL USE OF NON CAIRE POWER SUPPLIES AND BATTERY PACKS CAN CAUSE DAMAGE TO THE UNIT AND IMPROPER OPERATION Push the battery release button downward away from the FreeStyle Comfort While HOLDING this button slide the battery out by pulling it away from the concentrator WARNING THE OXYGEN CONCENTRATOR MUST BE OFF AND DISCONNECTED FROM EXTERNAL POWER BEFORE REMOVING THE BATTERY PACK BATTERY PACK The FreeStyle Comfort can be operated by the rechargeable battery pack which is supplied with the device There are no operational limitations of the concentrator when running from the battery pack All flow rates are available on battery power CHECKING BATTERY PACK CHARGE To check the battery charge when it is installed in the FreeStyle Comfort reference the battery icon and the estimated time remaining on the display INSTALLING THE BATTERY Align the battery with the bottom housing from the center of the FreeStyle Comfort Push the battery inward until you hear a click to confirm that it has locked in place 80 100 60 80 40 60 20 40 20 PN MN232 C User Manual AMSR oxygenconcentratorstore com ENG 13 1 877 774 9271

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FreeStyle Comfort Note If the battery is in the process of charging a plug indicator will show instead of the charge percentage remaining To check the battery charge when it is not installed in the FreeStyle Comfort lay it flat and press the TEST button The battery gauge indicator lights 25 100 will illuminate to the right of the TEST button to indicate the level of the battery pack charge BATTERY OPERATING DURATION When external AC or DC power is disconnected the concentrator will automatically switch over to using battery power if a charged battery is installed The table below shows the typical durations for a new battery pack Battery pack durations will remain constant regardless of your breath rate Pulse Setting Single 8 cell Battery Duration Double 16 cell Battery Duration 1 up to 8 hours up to 16 hours 2 up to 4 25 hours up to 8 5 hours 3 up to 3 hours up to 6 hours 4 up to 2 25 hours up to 4 5 hours 5 up to 2 hours up to 4 hours TYPICAL BATTERY RECHARGE TIME The typical time to fully recharge your battery pack from a fully discharged battery is 3 5 hours for a single battery and 6 0 hours for a double battery INITIAL CHARGING The new battery supplied with your FreeStyle Comfort is only partially charged when it is shipped from the factory Before using for the first time you should fully charge the battery pack using either AC or DC power Note The battery may not initially start charging if the battery pack has been fully depleted BATTERY SERVICE LIFE The FreeStyle Comfort batteries are designed to last 300 charge discharge cycles GENERAL CHARGING INFORMATION The FreeStyle Comfort will recharge the battery pack anytime it is installed in the concentrator and the concentrator is connected to an external AC or DC power source except on an airplane Battery is fully charged when it displays 100 Alternately the battery pack may be charged using the optional desktop charger 14 ENG PN MN232 C User Manual AMSR oxygenconcentratorstore com 1 877 774 9271

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FreeStyle Comfort AC DC Power Supply The FreeStyle Comfort comes standard with AC and DC power supplies The AC power supply includes the following a AC Power brick that operates between 100 240 volts 50 60Hz b AC Power cord to connect to the power brick and corresponding AC outlet The DC power supply consists of a cord that plugs directly into the unit and the DC outlet 2 Connect the AC power cord to the AC power brick AC POWER AC power is for use at home or wherever standard AC outlet power is available The FreeStyle Comfort is fully functional on AC power The FreeStyle Comfort will also recharge the battery pack any time AC power is available except on an airplane The battery pack will recharge whether the FreeStyle Comfort is powered on or off WARNING DO NOT CONNECT EXTERNAL POWER WITHOUT A BATTERY PACK INSTALLED IN THE OXYGEN CONCENTRATOR To connect the FreeStyle Comfort to AC Power 1 Connect the AC power brick to the power connector inlet on the front right bottom of the FreeStyle Comfort Be sure to push inward so that the connection is secure 3 Connect the opposite end of the AC power cord to the wall or other appropriate electrical outlet PN MN232 C User Manual AMSR oxygenconcentratorstore com ENG 15 1 877 774 9271

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FreeStyle Comfort 4 Turn on the FreeStyle Comfort by pressing the power button and select your prescribed flow setting utilizing the increase or decrease flow buttons Note If the battery pack needs to be recharged the battery icon on the display will have a single orange bar DC POWER 3 Connect the opposite end of the DC power cord to the automobile or other DC accessory outlet 4 Turn on the FreeStyle Comfort by pressing the power button and select your prescribed flow setting utilizing the increase or decrease flow buttons Note If the battery pack needs to be recharged the battery icon on the display will have a single orange bar DC power is for use in the accessory outlets of automobiles boat or other motor vehicles The FreeStyle Comfort is fully functional for use on DC power The FreeStyle Comfort will also recharge the battery pack if needed any time DC power is available The battery pack will recharge both if the unit is off or on and in use WARNING DO NOT CONNECT EXTERNAL POWER WITHOUT A BATTERY PACK INSTALLED IN THE OXYGEN CONCENTRATOR WARNING DO NOT OPERATE THE DEVICE ON 12 VDC CAR OUTLETS WHILE THE VEHICLE IS TURNED OFF 1 Turn on your motor vehicle 2 Connect the DC power supply to the power port receptacle front bottom right side of the FreeStyle Comfort Be sure to push inward so that the connection is secure 16 ENG PN MN232 C User Manual AMSR oxygenconcentratorstore com 1 877 774 9271

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FreeStyle Comfort Cleaning Care Routine Maintenance ROUTINE MAINTENANCE Servicing of internal components inside of the cabinet of the FreeStyle Comfort must be performed by the oxygen provider The operator of the unit is responsible for the following maintenance procedures Weekly Clean the Air Intake Filters WARNING DO NOT ATTEMPT TO OPEN OR REMOVE THE PLASTIC COVERS OF THE OXYGEN CONCENTRATOR THE UNIT SHOULD ONLY BE OPENED BY A QUALIFIED SERVICE TECHNICIAN AIR INTAKE FILTERS Air enters the FreeStyle Comfort through air intake filters located on the front bottom of the oxygen concentrator These filters prevent dust and other large particles in the air from entering the unit At least once per week the air intake filters should be cleaned Your oxygen provider may advise you to clean them more frequently depending upon the operating conditions Follow these steps to properly clean the air intake filters 1 Remove the two filters from the front of the FreeStyle Comfort by pushing up on the corresponding tab and pulling outward 2 Wash both filters in a warm solution of soap and water 3 Rinse the filters thoroughly and remove excess water with a soft lint free cloth Ensure the filters are completely dry before replacing it 4 Re install the clean dry filters WARNING DO NOT OPERATE THE OXYGEN CONCENTRATOR WITHOUT THE AIR INTAKE FILTER IN PLACE BATTERY PACK CARE Do not allow the battery pack to be exposed to liquids Do not attempt to disassemble or open the battery pack Do not expose the battery to open flames Do not drop the battery pack Keep the battery pack away from children If your battery pack appears damaged contact your oxygen provide before use Do not place the battery in or near a microwave or other cooking appliances BATTERY PACK STORAGE 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 Do not leave the battery in a location exposed to excessive heat such as in direct sunlight or in a car Doing so could cause the battery s performance and life to deteriorate It may also cause the battery to generate heat smoke catch fire or explode The battery pack should be stored in a stable environment characterized by low humidity less than 70 RH and free of corrosive gasses To prevent rust PN MN232 C User Manual AMSR oxygenconcentratorstore com ENG 17 1 877 774 9271

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FreeStyle Comfort avoid conditions that can create condensation such as rapid fluctuations in the ambient temperature For storage of a month or more a discharged or partial charged state of charge between 50 and 75 two to three LEDs is recommended Once charged remove the battery from the oxygen concentrator WARNING USE A DAMP NOT WET CLOTH OR SPONGE TO CLEAN THE BATTERY PACK FIRST SPRAY THE CLOTH OR SPONGE WITH A MILD HOUSEHOLD CLEANER AND CLEAN THE BATTERY PACK HOUSING WARNING DO NOT DISINFECT CLEAN WITH AUTOMATED WASHING SYSTEM CANNULA REPLACEMENT CLEANING Turn OFF the unit and disconnect from AC or DC power before any cleaning or disinfection DO NOT spray the outer case directly Use a damp not wet cloth or sponge Spray the cloth or sponge with a mild disinfectant solution to clean the cabinet and power supplies Proceed as directed by the cleaner manufacturer WARNING 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 Always follow the cannula manufacturer s instructions for proper use Replace the nasal cannula or oxygen tubing every 3 to 6 months if daily use 3 months as per manufacturer s recommendation as recommended by the cannula manufacturer or your oxygen provider Your physician or oxygen provider will provide you with cleaning and replacement instructions Additional supplies for replacement are available through your oxygen provider WARNING CARE SHOULD BE TAKEN TO PREVENT THE OXYGEN CONCENTRATOR AND THE BATTERY PACK 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 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 OILBASED PRODUCTS THESE ARE NOT TO BE USED TO CLEAN THE PLASTIC HOUSING ON THE CONCENTRATOR AS THEY CAN DAMAGE THE UNIT WARNING 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 CONCENTRATOR PAY SPECIAL ATTENTION TO THE OXYGEN OUTLET FOR THE CANNULA CONNECTION TO MAKE SURE IT REMAINS FREE OF DUST WATER AND PARTICLES 18 ENG PN MN232 C User Manual AMSR oxygenconcentratorstore com 1 877 774 9271

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FreeStyle Comfort Alarm Conditions Priority Alarm Description 1 Audible Signal More Details System Malfunction Battery Over Temp 1 beep every 20 sec Unit will alarm when battery temperature is approaching saftey shutdown threshold System Malfunction High Temperature 1 beep every 20 sec Unit will alarm when internal temperature is approaching shutdown threshold 3 System Malfunction High Pressure 1 beep every 20 sec If shutdown threshold is reached unit will shut down and alarm screen will display and audible alarm will continue for 2 min 4 No Breath detected 1 beep every 30 sec No breath detected for 15 seconds 5 Low Battery Shut Down 1 beep every 30 sec Alarms until battery runs out of power and unit shuts down 6 Warm Up none Unit will start by auto dosing until a breath is detected or Warm up ends whichever is sooner 7 Low Concentration 1 beep every 30 sec for up to 5 min 2 Display If shutdown threshold is reached unit will shut down If external power is connected alarm screen will display and audible alarm will continue for 2 min If shutdown threshold is reached unit will shut down and alarm screen will display and audible alarm will continue for 2 min Activated after first breath or warm up screen is off whichever comes sooner PN MN232 C User Manual AMSR oxygenconcentratorstore com ENG 19 1 877 774 9271

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FreeStyle Comfort Priority Alarm Description Display Audible Signal 8 System Malfunction Flow Rate OCD Valve Failure Obstruction of Gas Pathway 1 beep every 30 sec 9 Low Battery Warning 1 beep no repeat 10 Breathing Rate Exceeded 1 beep every 60 sec 11 System Malfunction Fan Failure none 12 System Malfunction Low Pressure none 13 System Malfunction Low Temp none Info Start up 1 info beep More Details Breathing Rate exceeds 40 bpm Screen displays at power on and you should hear one beep to confirm buzzer is functioning Start up screen display current firmware revision in bottom right corner Info Normal Run Screen no DC Power connected 20 ENG none PN MN232 C User Manual AMSR oxygenconcentratorstore com 1 877 774 9271

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FreeStyle Comfort Priority Alarm Description Display Audible Signal Info Setting Changed 1 info beep Info Plug in external Power in the off condition none Info Plug in external power in the run condition none Info Unplug external power in the off Condition 1 info beep Info Unplug external power in the run Condition with battery present 1 info beep More Details Display CAIRE screen for 2 seconds followed by Battery Plug status for 5 sec before screen turns off Display CAIRE screen for 2 seconds and then turn display off PN MN232 C User Manual AMSR oxygenconcentratorstore com ENG 21 1 877 774 9271

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FreeStyle Comfort Priority Alarm Description Info Audible Signal More Details In Standby Mode when up or down button is pressed display shows battery and charging state none Screen will display for 5 sec then turn off Info Airplane Mode on battery power 1 long beep Info Airplane Mode while plugged in 1 long beep 22 ENG Display PN MN232 C User Manual AMSR oxygenconcentratorstore com 1 877 774 9271

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FreeStyle Comfort Troubleshooting Problem Probable Cause Solution FreeStyle Comfort displays alarm and produces intermittent beep Refer to Alarm Conditions table Refer to Alarm Conditions table Oxygen concentrator does not turn on Battery is discharged Power the unit through the AC or DC outlet Not connected to external power Ensure that external connects are secure General malfunction Perform a Full Power Cycle by removing the battery and disconnecting any AC or DC external power source Then reinstall battery and the power cycle is complete Reconnect external power source if desired Contact your Equipment Provider and change to another source of oxygen as necessary All other problems Perform a Full Power Cycle by removing the battery and disconnecting any AC or DC external power source Then reinstall battery and the power cycle is complete Reconnect external power source if desired Change to another source of oxygen as available and contact your Equipment Provider Note Some alarms will cause the unit to shut down Note During a total power loss the alarm system resets clears any previous alarms and will only display an alarm if the condition still exists once power is restored PN MN232 C User Manual AMSR oxygenconcentratorstore com ENG 23 1 877 774 9271

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FreeStyle Comfort ACTIVATE AIRPLANE MODE Travel Information The FreeStyle Comfort is FAA approved for use on board commercial aircraft Prior to any travel airline train cruise etc you should Ensure the concentrator is in good operation condition Contact your carrier at least 48 hours prior to departure to inform them you will be traveling with a FreeStyle Comfort It is suggested to always carry extra batteries with you on trips For airline travel please allow enough battery life to account for ground time preflight check in security etc and layovers Most airlines require that you have an adequate number of fully charged battery packs to power the device for at least 150 of the expected maximum trip duration flight times ground time before and after the flight connections and unexpected delays Battery Power POC can be used on an aircraft per normal operating procedures using Battery Power ONLY when no external power source is connected External Power On an airplane if an electrical outlet is available operable and its location is appropriate for use as a POC power source it may serve as a back up to POC batteries In this case the following recommended procedure regarding the transition from battery to aircraft electrical power must be followed 1 Turn POC On using Battery Power ONLY when no external power source is connected Note If flying it is recommended that extra batteries are carried on in a secure carrying bag FAA REGULATION Spare batteries must be individually protected to prevent short circuits by placement in the original retail packaging or by otherwise insulating the terminals e g by taping over exposed terminals or placing each battery in a separate plastic bag or protective pouch and carried in carry on baggage only 2 Enable Airplane Mode Press and hold both Up and Down buttons for 5 seconds until you hear a long beep and see the Airplane symbol appear 3 When the airplane symbol is displayed plug in the POC Note Due to aircraft limitations the batteries do not charge in Airplane Mode 24 ENG PN MN232 C User Manual AMSR oxygenconcentratorstore com 1 877 774 9271

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FreeStyle Comfort Accessories INSERTING UNIT INTO CARRYING BAG For proper performance and safety use only these listed accessories supplied by CAIRE through your oxygen provider Use of accessories not listed below could adversely affect the performance and or safety of the concentrator 1 Insert unit into bottom of bag properly aligning filters and battery openings FreeStyle Comfort Standard Accessories Carrying Bag MS396 1 Shoulder Strap MS397 1 AC Power Supply All Cords Included 4997 SEQ DC Power Cord CD04 1 External Gross Particle Filter Right FI226 1 External Gross Particle Filter Left FI227 1 2 Secure zipper around bottom of pouch Optional Accessories Available Additional 8 Cell Battery Pack BT034 1S 16 Cell Battery Pack BT035 1S Desktop Battery Pack Charger BT036 1 Carry all Accessory Bag MI372 2 Note Additional options may be available for country specific power cords where noted above Contact CAIRE or your oxygen provider if alternate options are needed for order SHOULDER STRAP INSTALLATION 1 Shoulder strap can be attached to either the unit directly or the carrying bag 2 Clip strap onto the ring on the unit or bag Carrying Bag Instructions To insert and secure your FreeStyle Comfort in the carrying bag utilize the following instructions PN MN232 C User Manual AMSR oxygenconcentratorstore com ENG 25 1 877 774 9271

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FreeStyle Comfort Disposal Always return FreeStyle Comfort including all components to your homecare provider for proper disposal You can also contact your local city or town offices for instructions on proper disposal of the battery Our products will comply with the restriction of Hazardous Substances RoHS directive They will not contain more than trace amounts of lead or other hazardous material content CAUTION For proper disposal contact your equipment provider or local government agency for disposal instructions WEEE and RoHS This symbol is to remind the equipment owners to return it to a recycling facility at the end of its life per Waste Electrical and Electronic Equipment WEEE Directive Materials in Direct Contact with the Operator Concentrator Casing PC ABS Concentrator Control Panel Polyester EBG7 or equivalent Concentrator Handle Polycarbonate Oxygen Outlet Nozzle Polycarbonate Unit Label Lexan Cord Connectors Polycarbonate Vinyl chloride Power Cord PVC Metal Power Supply Lexan 940 Polycarbonate Battery Pack PC ABS Battery Pack Power Supply Labels Polyester film Concentrator Carrying Case Cordura Neoprene Nylon Lining Strap Polypropylene Acetyl Vinyl Cordura Neoprene EMC Testing Guidance and Manufacturer s Declaration Electromagnetic Emissions The FreeStyle Comfort is intended for use in the electromagnetic environment specified below The customer or the user of the FreeStyle Comfort should assure that it is used in such an environment Emissions Test RF emissions CISPR 11 RF emissions CISPR 11 Harmonic emissions IEC 61000 3 2 Voltage fluctuations flicker emissions IEC 61000 3 3 26 ENG Compliance Electromagnetic Environment Guidance Group 1 The FreeStyle Comfort uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment Class B Class A Complies The FreeStyle Comfort is suitable for use in all establishments including domestic establishments and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes PN MN232 C User Manual AMSR oxygenconcentratorstore com 1 877 774 9271

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FreeStyle Comfort Guidance and Manufacturer s Declaration Electromagnetic Immunity The FreeStyle Comfort is intended for use in the electromagnetic environment specified below The customer or the user of the FreeStyle Comfort should assure that it is used in such an environment Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance Electromagnetic Floors should be wood concrete or environment 8 kV contact 8 kV contact ceramic tile If floors are covered with guidance synthetic material the relative 15 kV air discharge 15 kV air discharge humidity should be at least 30 IEC 61000 4 2 Electrical fast transient burst IEC 61000 4 4 Surge IEC 61000 4 5 2 kV for power supply 2 kV for power lines supply lines 1 kV for input output lines 1 kV line s to line s 2kV common mode on AC lines N A 1 kV line s to line s 1kV differential on AC lines Mains power quality should be that of a typical professional healthcare facility and home healthcare environments Mains power quality should be that of a typical professional healthcare facility and home healthcare environments 2kV common mode on outdoor I O lines 0 UT for 0 5 cycle 0 0 UT for 0 5 cycle 0 45 90 135 180 45 90 135 180 Mains power quality should be that 225 270 315 225 270 315 of a typical professional healthcare Voltage dips short facility and home healthcare envi0 UT for 1 cycle 00 ronments If the user of the FreeStyle interruptions and 0 UT for 1 cycle 00 voltage variations Comfort requires continued operation on power supply during power mains interruptions it is 70 UT 30 dip in 70 UT 30 dip in UT input lines IEC recommended that the FreeStyle UT for 25 30 cycles 0 for 25 30 cycles 0 61000 4 11 Comfort is powered from an 00 uninterruptible power supply or a battery 0 UT for 250 300 0 UT for 250 300 0 cycles 0 cycles 00 Power frequency magnetic fields Power frequency should be at levels characteristic of 50 60 Hz mag3A m 3A m a typical location in a professional netic field IEC healthcare facility and home health61000 4 8 care environments NOTE UT is the A C mains voltage prior to application of the test level NOTE In some cases the Freestyle Comfort may reset after a significant Electrostatic Discharge and may require a Full Power Cycle to resume normal operation See Troubleshooting section for more details PN MN232 C User Manual AMSR oxygenconcentratorstore com ENG 27 1 877 774 9271

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FreeStyle Comfort Guidance and Manufacturer s Declaration Electromagnetic Immunity The FreeStyle Comfort is intended for use in the electromagnetic environment specified below The customer or the user of the FreeStyle Comfort should assure that it is used in such an environment Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance 10 Vrms Portable and mobile RF communica10 Vrms Conducted RF tions equipment should be used no 150 kHz to 80 MHz IEC 61000 4 6 closer to any part of the FreeStyle Comfort including cables than the recommended separation distance calculated from the equation applicable 10 V m 10 V m Radiated RF to the frequency of the transmitter 80 MHz to 2700 MHz IEC 61000 4 3 Recommended separation distance d 1 2 P d 1 2 P 80 MHz to 800 MHz d 1 2 P 800 MHz to 2700 MHz 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 metres m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey a should be less than the compliance level in each frequency range b Interference may occur in the vicinity of equipment marked with the following symbol NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people a Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the FreeStyle Comfort is used exceeds the applicable RF compliance level above the FreeStyle Comfort should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as re orienting or relocating the FreeStyle Comfort b Over the frequency range 150 kHz to 80 MHz field strengths should be less than 10 V m 28 ENG PN MN232 C User Manual AMSR oxygenconcentratorstore com 1 877 774 9271

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FreeStyle Comfort Recommended separation distances between portable and mobile RF communications equipment and the FreeStyle Comfort The FreeStyle Comfort is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the FreeStyle Comfort can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the FreeStyle Comfort as recommended below according to the maximum output power of the communications equipment Rated maximum Separation distance according to frequency of transmitter output power of m transmitter 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz d 1 2 P d 1 2 P d 1 2 P W 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23 For transmitters rated at a maximum output power not listed above the recommended separation distance d in metres 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 Classification Type of protection against electric shock Class II Protection from electric shock is achieved by double insulation Degree of protection against electric shock Type BF Equipment providing a particular degree of protection against electric shock regarding 1 allowable leakage current 2 reliability of protective earth connection if present Not intended for direct cardiac application Independent testing for Medical Electrical Equipment Standard Tested to be in compliance with IEC 60601 1 edition 3 1 Medical Electrical equipment Part 1 General Requirements for safety CAN CSA C22 2 No 60601 1 8 edition 2 1 Medical Electrical Equipment Part 1 General Requirements for Safety Protection against potential electromagnetic or other interference between the equipment and other devices Tested to be in compliance with EN 60601 1 2 IEC 60601 1 2 4th Edition Tested to be in compliance with RTCA DO160 Section 21 Category M CISPR 11 EN 55011 Class B Group 1 Industrial Scientific and Medical ISM Equipment FCC Part 15 Subpart B Class B Unintentional Radiators IP22 Protection against ingress of fingers or similar objects greater than 12 5 mm diameter Vertically dripping water shall have no harmful effect when the enclosure is tilted at an angle of 15 from its normal position Method of cleaning and infection control allowed Please refer to Cleaning Care and Proper Maintenance section of this FreeStyle User Manual Degree of safety of application in the presence of flammable anesthetic gases Equipment not suited for such application Mode of operation Continuous duty PN MN232 C User Manual AMSR oxygenconcentratorstore com ENG 29 1 877 774 9271

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FreeStyle Comfort Notes 30 ENG PN MN232 C User Manual AMSR oxygenconcentratorstore com 1 877 774 9271

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FreeStyle Comfort Notes PN MN232 C User Manual AMSR oxygenconcentratorstore com ENG 31 1 877 774 9271

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American Medical Sales and Rental 7032 S Revere Parkway Suite 320 Centennial CO 80112 1 877 774 9274 AMSR oxygenconcentratorstore com 1 877 774 9271