USER MANUAL - O2 Concepts
Contents
1. 42 Air Inlet Filter Cleaning 42 Battery Disposal 44 Device Disposal cnr Bodl idi fos foa Ede 44 Section 7 Standards Compliance Section 1 Introduction Symbols Reference ICON MEANING ICON MEANING Off BUTTON Use e Or ols On o ype BF Equipmen dispose of in i household waste Pulse Mode m Keep dry in transport and TN storage Breath Detect Icon Not suitable for usein the presence of a flammable anesthetic mixture Increase Flow Setting No smoking while using or neardevice LI Decrease Flow Setting No open flames D Caution as seen in manual Warning asseen in manual e Oxlife Independence protects again solid objects ov er 12mm and direct sprays of waterup to 15 of v ertical IEC 60529 The device conforms to Directiv e 93 42 EEC concerning medical devices The Oxlife Independence complies with IEC 60601 1 3 Edition Medical Electrical Equipment Part 1 General Requirements for Basic Safety and Essential Performance How to Contact O2 Concepts Please contact your homecare provider if your Oxlife Independence requires service Please call O2 Concepts Technical Support at 1 877 867 4008 for support with your Oxlife Independence Please call Customer Service toreport any unexpected operation and events associated withthe device Information2. 18 Applhed 19 Section 4 Operating Instructions 20 Before OPETAN uictor aec 20 Locating Your 21 Device Selling p n e RID 22 PULSE MODE BOLUS VOLUMES 23 Installing and Removing the Battery 24 Typical Battery Operation Times 24 Battery Time 20 AC Power Supply 26 DC Power Supply Aufo 2 DC Power Supply Information Guide for Use 28 DC Power Supply Troubleshooting Guide for Use 29 UCI GUNG eM E 3 BOG oc ooa n d 32 Camnula eed 33 HUoinidilsr aaa 34 Firesafe Cannula 35 Section 5 User Alerts and Alarms Alarm and 37 How to Simulate Alarms and Alerts Providers eu er vente 38 How to Respond to Alarms 40 Section 6 Maintenance and Cleaning 42 42 User Care
3. Invalid Box Temperature High Priority Technical Unauthorized Battery Alert Medium Priority Technical Unauthorized Battery Alarm High Priority Technical Low External Alert Medium Priority Technical Low External Alarm High Priority Technical High External Power Alarm High Priority Technical No External Power Alarm High Priority Technical 39 When the internal box temperature sensor is out of a valid range the screen will flash red at 2Hz sound a 10 beep sequence repeated after 2 5seconds of silence and the text Invalid Box Temperature will flash in the system status window The unit will continue to sound until the power button is pressed to silence the audio the power button is held to power off the unit or 15seconds has expired If the unit detects that a battery other thanone from C2 Concepts has been installed in the unit the battery icon will show an exclamation point within the battery outline The unit will continue to run if on AC DC or a second valid battery is present The screen wil turn amber sound a 3 beep sequence repeated after 15seconds of silence and the text Unauthorized Battery will flash in the system status window Pushing POWER button once silences the bee ping If the unit detects that a battery other thanone from C2 Concepts hos been installe din the unit the battery icon will show an exclamatio
4. D Clean the outside case of your dev ice using a soft cloth dampened with a mild detergent and water D DO NOT spray orsoak the case or front panel Air Inlet Filter Cleaning Regular cleaning of the Air Inlet Filteris the only maintenance you will perform on your device To keep your Oxlife Independence working properly it is recommended you clean the Arr Inlet Filter weekly If the Oxlife Independence is used in a dusty environment more frequent Cleaning of the Air Inlet Filter may berequired Nev er use your Oxlife Independence without an Air Inlet Filter Air Inlet Filter Cleaning Continued Follow these simple directions to clean the Air Inlet Filter IR Remov e the Air Inlet Filter Wash the filter by running underwarmtap waterusing a mild detergent Rinse thoroughly under warm running water Squeeze out excess water Itis important to allow the filter to dry completely before reinserting into the dev ice Moisture from a wet or damp Air Inlet Filter may damage your dev ice You may want to keep an extra Air Inlet Filter to use as a replacement while one is drying AIRINLET FILTER Contact your authorized dealer for extra Air Inlet Filters 43 44 Battery Disposal Your battery isrechargeable and canbe recycled Always return to your authorized dealer for proper disposal You can also contact yourlocal city or town offices for proper disposal instructions fora lithiumion battery Device Disposal
5. This product may contain substances that could be harmful to the environment if disposed ofin landfills that are inappropriate Follow local governing ordinances and recycling plans regarding disposal of the dev ice 45 Section 7 Standards Compliance This dev ice is designed to comply with the following standards IEC 60601 1 39 Edition Medical Electrical Equipment Part 1 General Requirements for Basic Safety and Essential Performance IEC 60601 1 2 2 9 Edition Medical Electrical Equipment Part 1 2 General Requirement for Safety Collateral Standard Electromagnetic EMC Compatibility ISO 8359 2 4 Edition Oxygen Concentrators for Medical Use Safety Requirements RTCA DO 160 Section 21 Category M Emission of Radio Frequency Energy ISO 13485 2003 Medical Devices Quality Management Systems Requirements for Regulatory Purposes 46 47 Oxlife INDEPENDENCE O2 Concepts LLC 15 Commerce Road Newtown CT 06470 877 867 4008 www o2 concepts com Represented in Europe by MT Promedt Consulting GmbH Altenhofstrasse 80 66386 St Ingbert Germany 0086 PN 800 1008 Rev C April 15 2015 48
6. oxygen if necessary Remove unauthorized battery and replace with an authorized O2 Concepts battery Remove unauthorized battery and replace with an authorized O2 Concepts battery Ensure all charging connections cre intact Refer to the DC user guide secion of this manual Ensure all charging connections cre intact Refer to the DC user guide secion of this manual Disconnect the external power source from the Oxlife Independence and use an alternative power source that is within the operating limits Ensure all charging connections are intact Inthe case of an extended power outage utilize an alternate non powered source of oxygen 42 Section 6 Maintenance and Cleaning Maintenance All maintenance MUST be conducted by a qualified Oxlife Independence serv ice technician DON OT attempt to disassemble or perform any maintenance on your device Any such attempt will void the warranty Routine cleaning of the air inlet filter as described below is the only routine maintenance The Oxlife Independence andits parts requires maintenance at the end of the 5 yearserv ice life or asrequired determined by yourcare prov ider There is no routine maintenance or serv ice to the O2 Concepts rechargeable batteries User Care and Cleaning A Unplug your Oxlife Independence andor power supplies before cleaning A DO NOT use alcohol ethylene chloride or petroleum based cleaners on the case or power supplies
7. Low Purity Alert Low Priority Technical Low Purity Alarm High Priority Technical No Flow Alarm High Priority Technical Over Temperature Alarm High Priority Technical Invalid Motor Temperature High Priority Technical How to Respond to Alarms Alarm Description When in PULSE a breath is not detected for 45 seconds the screen wil turn amber sound one beep and the text ALERT No Breath will flash in the system status window If no breath is detected for an additional 15 seconds the unit wil switch to the previous CONTINUOUS mode setting selected When calculated battery run time reaches 6 minutes the screen wil turn amber sound one beep per30 seconds and the text ALERT Low Battery will flash in the system status window Pushing POWER button once silences the beeping When battery power is depleted the pump shuts off the screen wil flash red at 2Hz sound a 10 beep sequence repeated after 2 5seconds of silence and the text Low Battery will flash in the system status window The unit will continue to sound until the power button is pressed to silence the audio the power button is held to power off the unit or 15seconds has expired When oxygen levels drop below 85 the screen wil turn amber sound one beep per 30seconds and the text ALERT Low Purity will flash in the system status window Pushing POWER button once silences the bee ping W
8. Section 3 Product Description Device and Accessories Informationregarding how to operate the Oxlife Independence and its accessories can be found in the following sections Product Description and Operating Instructions D The use of certainhumidifiers and administration accessories not specified for use withthis oxygen concentrator may impair performance Accessories for the Oxlife Independence Battery Battery Shell Blank Desktop Charger Single Bay Desktop Charger 6 Bay AC Power Supply DC Power Cord Accessory Bag Humidifier Kit ft Cannula 50 Cannula Firesate Cannula Valve 16 Feature Identification CONTROL PANEL LCD DISPLAY OXYGEN OUTLET PORT EXHAUST PORT WHEELS RECHARGEABLE BATTERY SLOTS FAA APPROVAL IDENTIFICATION PULL HANDLE AIR INTAKE PORT FILTER 10 EXTERNAL POWER INPUT 11 HANDLE LOCK RELEASE BUTTON 12 CARRY HANDLE RS UIN 12 CARRY HANDLE 17 Understanding the Control Panel 13 POWER BUTTON 14 BATTERY STATUS 15 EXTERNAL POWER SOURCE CHARGING INDICATOR 16 NCREASE UP BUTTON 17 DECREASE DOWN BUTTON 18 SYSTEM STATUS 19 BREATH DETECT PULSE MODE ONLY 20 MODE SETTING 21 MODE BUTTON OXLIFE INDEPENDENCE get Ed nL sreath pa FLOW OK 000 P PURITY OK a 18 Applied Parts The applied parts or components that a patient will come in contact
9. gt gt gt RB Batteries will not charge at any setting if the engine is not running DC poweris not sufficient to charge the batteries at all settings Charging will NOT occur at settings higher than Continuous 2 0 or Pulse 4 0 The device may rev more while operating on DC power This is normal operation while connected to DC power andnot cause forany concern DO NOT leave the device plugged into the v ehicle when the engine is not running A DO NOT use the Oxlife Independence with anypower splitting devices 27 DC Power Supply Information Guide for Use Starting the Device on DC Power 1 Be sure that the vehicle s engine is running PRIOR to plugging in your Oxlife Independence Plug DC power cord into the device before plugging into the vehicle s DC outlet Plug DC power cord into the vehicle s DC outlet Remove the DC power cord from the vehicle s DC outlet when the engine is not running Stopping the device on DC power 1 Without batteries installed keep the vehicle s engine running and power the device Off by pressing and holding the power button henthe device Off disconnect the DC power cord from the vehicle s DC outlet With batteriesinstalled disconnect the DC power cord from device The device will beep once and switchtointernal battery power To Reset Reboot l 28 With batteries installed remove DC power from the device and wait 15 seconds Remove the ba
10. FLOW MODE CONTINUOUS In Continuous Flow Mode a continuous flow of oxygen wil A flow through the cannula andinto your nose The oxygen is measured in Liters per Minute or LPM PULSEFLOW MODE PULSE A In Pulse Flow Mode the device will detect your breath 2668 and supply a measured pulse of oxygen or bolus The breath detect icon will flash on the control panel with each breath At higher flow settings you may notice the motor revving which normal and necessary to achieve maximum oxygen output PULSE MODE BOLUS VOLUMES o f no breath is detected for 45 seconds the display screen will turn amber and the device will beep once f no breath is detected for an additional 15 seconds the device will default to the previous continuous flow mode setting 23 Installing and Removing the Battery INSTALL REMOVE SLIDE INTO BACK OF DEVICE BATIERY PULL TAB AWAY FROM UNIT LIFT WILL DROP DOWN SLIGHTLY AND BATTERY UPSLICHTLY THEN SLIDE CLICK INTO POSITION STRAIGHT OUT Typical Battery Operation Times 20 Breaths Minute PULSE FLOW FLOW RATE Hours of Battery Life OPERATING TIME WILL DEGRADE WITH BATTERY USE AND AGE 24 Battery Time Management With the combined use of the battery AC powercord and DC powercord your time away from home is virtually limitless Using the AC and DC power cords whenever possible will giv e you optimal battery life The battery will charge in the device when plugged into an exter
11. source This is a continuous operation device Cannula Specification A W eighted Sound Pressure Level DO NOT use cannula tubing longer than 7ft 2 13m w hen using Pulse Fow Mode Do NOT use cannula tubing longer than 50ft 15 25m w hen using Continuous Flow Mode The volume that the device ill reach at maximum settings w illbe 56dBA with maximum peaks of 58 8 Alarm Sound Level All alarms triggered by the device ill be 85cBA at ee imrommem EA Maximum Outlet Pressure Device ill maintain flow upto 5psi back pressure ss inoummbacepeenuen Oo Device 5yrs Accessories lyr 10 11 Contraindications Under certain circumstances the use of non prescribed oxygen therapy can be hazardous This device should only be used when prescribed by a physician Not for use in the presence of aerosol sprays or flammable anesthetics Additional monitoring may be required for patients using this device who are unable to hear or see alarms or communicate discomfort The Oxlife Independence is not appropriate for any patient who would experience adverse health consequences as a result of a temporaryinterruptionin oxygen therapy he availability of an alternate source of supplemental oxygen is strongly recommended in the case of power interruption or a mechanical failure of the device This device is for adult use only It is not qualified for use by pediatric patients Indications for Use gt PRE
12. to lubricate the oxygen outlet port Read and follow the instructions included with the cannula and follow the instructions giv en by your authorized dealer Place the cannula over your ears and position the cannula prongs in your nose Clean and replace your cannula regularly as instructed by your authorized dealer O2 Concepts recommends 125310 from Salter Labs or equiv alent as a 7ft cannula and 1650HF 50 10 from Salter Labs or equivalent asa 50 cannula Oxygen Port 34 Humidifier Kit The O2 Concepts Oxlife Independence portable oxygen concentrator is designed to be used witha humidifier bottle in continuous flow mode only Use of this Device with a humidifier in pulse mode may impair performance and or damage your device DO NOT overfill humidifier Fill the humidifier with distilled water only to the level shown by the manufacturer of the humidifier bottle DO NOT reverse the oxygen input and output connections W ater from the humidifier will trav el through the cannula and back tothe patient DO NOT operate your O2 Concepts Oxlife Independence and ambulate while a humidifier is attached Always remove the humidifier before walking DO NOT lay your device down horizontally while attachedtoa humidifier Using the Humidifier O2 Concepts recommends using the 800 1015 Humidifier Bottle Strap to attach your humidifier to your oxygen concentrator 1 Raise the Oxlife Independence handle slide the humid
13. with during normal operation of the device are listed below l Handle 2 Display 3 Oxygen Port 19 Section 4 Operating Instructions Before Operating Your authorized dealer willand orshould demonstrate proper operation of your Oxlife Independence This manual should be saved for future reference to help you safely operate your dev ice If you have any further questions please contact your authorized dealer This equipment needs to be installed and put into service in accordance with the information provided in the accompanying documents DO NOT operate the Oxlife Independence without first reading the Safety Guidelines included in SECTION 2 of this manual Please follow all operating instructions If you arerelocating your Oxlife Independence from an extreme environment allow the device toreturm to the specified operating temperature and humidity ranges before use Operating your device outside of specified ranges may dama ge your device impact device performance and may void yourwarranty See Operating Temperature and Humidity Ranges listed in the Specification Table Fully charge batteries before first use 20 Locating Your Device Place the Oxlife Independence in a well v entilated area free of smoke fumes pollutants and away from direct sun light Av oid high humidity environments Ensure that air intake and exhaust ports are not obstructed The Oxlife Independence MUST be located so that alarms can b
14. 85 the screen will turn amber sound beep per 30 seconds and the text ALERT Low Purity will flash in the system status window Pushing POWER button once silences the beeping When oxygen levels drop below 72 the screen will flash red at 2Hz sound a 10 beep sequence repeated after 2 5 seconds of silence and the text Low Purity will flash in the system status window The unit will continue to sound until the power button is pressed to silence the audio the power button is held to power off the unit or 15seconds has expired When the flow of oxygen is stopped for 45 seconds the screen wil flash red at 2Hz sounda 10 beep sequence repeated after 25 seconds of silence and the text No Flow wil flash in the system status window The unit will continue to sound until tne power button is pressed to silence the audio the power button is held to power off the unit or 15seconds has expired The maximum operating temperature of the enclosure ond pump is 70C and 90C respectively When either of these temperatures are reached the screen will flash red at 2Hz sound a 10 beep sequence repeated after 2 5seconds of silence and the text OverTemperature will flash in the system status window The unit will continue to sound until the power button is pressed to silence the audio the power button is held to power off the unit or 15seconds has expired When the motor temperature sensor is out of a valid ran
15. Oxlife INDEPENDENCE USER MANUAL PORTABLE OXYGEN CONCENTRATOR USER READ THIS MANUAL BEFORE OPERATING THIS DEVICE SAVE THIS MANUAL FOR FUTURE REFERENCE DEALER THIS MANUAL MUST BE GIVEN TO THE END USER PROUDLY MADE IN THE U S A PLEASE READ THIS OPERATION MANUAL CAREFULLY BEFORE USING THIS DEVICE BE AWARE OF ALL WARNINGS AND SAFETY INFORMATION ONLY USE ACCESSORIES APPROVED BY 02 CONCEPTS AND REFERENCED WITHIN THIS MANUAL IF YOU DO NOT FULLY UNDERSTAND ALL THE WARNINGS SAFETY PRECAUTIONS AND OPERATING INSTRUCTIONS CONTACT YOUR AUTHORIZED DEALER OR PROVIDER FOR TECHNICAL SUPPORT CAUTION U S FEDERAL LAW RESTRICTS THESE DEVICES TO SALE BY OR ON THE ORDER OF A PHYSICIAN Table of Contents Table of Contents Section 1 Introduction eese Symbols Reference 7 How to Contact O2 9 SDecincallolis Siia 10 Indications Tor Use io tne sunset 12 Section 2 Safety Guidelines 13 Device Safety Guidelines 13 Battery and Power Supply Safety Guidelines 15 Section 3 Product Description 16 Device and Accessories 16 Feature Identification 17 Understanding the Control
16. SCRIBED MODE AND FLOWSETTINGS SHOULD ONLY BE ADJUSTED UNDER THE ADVICE OF A PHYSICIAN A The O2 Concepts Oxlife Independenceis indicated on a prescription basis for the administration of supplemental oxygen It is not intended for life support nor does it prov ide any patient monitoring capabilities A Federal law restricts this dev ice to sale by or on the order of a physician A No modification of this equipment is allowed There is no know interference posed by ME equipment during specific inv estigations or treatments There are no known devices that will cause interference issues 12 e o 00 ese 13 Section 2 Safety Guidelines Device Safety Guidelines Avoid exposure to open flames or creation of any spark near your Oxlife Independence This includes sparks fromstatic electricity created by any type of friction Protect electrical power cords fromsharp edges to avoid electrical shock and serious physical injury Locate the Oxlife Independence in a wellv entilated area to allow for adequate airintake Av oid the intake of airbome pollutants smoke or fumes Use only approved accessories as specified in this User Manual Use of non approv ed accessories may cause serious damage to the device and will v oid the warranty Locate oxygen tubing and power cords away from hot surfaces and in a mannerto prev enttripping hazards DO NOT Operate the device in an enclosed space such asa closet DO NOT blockthe air inlet or
17. about the Oxlife Independence and O2 Concepts can also be found on our website at www o2 concepts com Device Dimensions w ith Handle W heels Specifications DIMENSIONS 20 29 y H 51 5 cm W 10 85in 27 55 D 9 45 in D 24 cm WEIGHTS Device W eight Cart Kit Wheels amp Pull Handle Battery AC Charger DC Charger MODES OF OPERATION Continuous Flow Pulse Dose Battery Specification Ex ternal Pow er Supply Pow er Input Altitude Oxygen Purity Operating Temperature Operating Humidity Operating Atmospheric Pressure Operating Environment Transport Storage Temperature 0 5 to 3LPM in 0 5 LPM increments Measured flow values w ithin 2 of actual values Max flow 3 0 LPM Flow maintained w ith outlet pressure ranging from to 5 0 psig 0 34kPa 0 5 6 0 8ML 96mL setting increments Measured flow values are w ithin 2 of actual values AC pow er 100 240 VAC 50 60 Hz 2 5 amps DC pow er 12 15 VDC Recommended 15A outlet at 12V 91 4 87 95 from 0 5 to 3 0 LPM Measured purity values w ithin 2 of actual values There is no variationin purity w ithinthe operating altitude 50 F 10 to 104 F 40 10 95 82 4 F 28 C 101kPa to 63kPa Free of smoke pollutants and fumes 4 F 20 C to 140 F 60 C Transport Storage Humidity 95 non condensing Operating Time 24 hours per day w hen connected to an external AC or DC pow er
18. commendation for Use Use no electrical outlets controlled by a switch When changing powersources wait forthe control panelto display the new powersource icon and unit to beep before remov ing the original source The detachable power supply cord to the power supply is the means of isolating the unit from the supply mains If AC poweris remov ed from the dev ice wait 10 seconds before re applying power When traveling internationally a standard international power plug adapteris all that is required EXTERNAL POWER INPUT 26 D Use only the power supplies prov ided with this dev ice The DC powersupply allows you to power your Oxlife Independence from your v ehicle s car boat RV 12 15 v olt DC outlet cigarette lighter in all settings Use the DC outlet closest to the battery Use no other DC outlets in the vehicle If your vehicles DC power drops below 11 5 volts the device will revert to battery power A 15 amp outlet at 12 volts is recommended for use with the device gt The external power supply icon will be displayed on the control panel Recommendations for Use ALWAYS have the vehicle s engine running before plugging in your Oxlife Independence With the engine running plugin and turn on your device When operating the Oxlife Independence in your vehicle ensure thatthe device is securely stowed and will not get damaged during transport Ensure that air inlet and exhaust ports are not blocked
19. continue to sound until tne power button is pressed to silence the audio the power button is held to power off the unit or 15seconds has expired If power is removed while the unit is running the unit will sound a 10 beep sequence repeated after 4 seconds of sience Since the poweris remove the display is blank and no backlight color is available Chil the unit to 34 deg F while off then turn on while still cold Install a battery from a manufacturer other than C2 Concepts while another power source is present Install a battery from a manufacturer other than C2 Concepts wth no other power source present Connect to an external DC power supply capable of delivering 20amps Run unit on 2 0 continuous Starting at 14 volts steadily reduce input voltage until unit alerts Connect to an external DC power supply capoble of delivering 20amps Run unit on 2 0 continuous Starting at 14 volts steadily reduce input voltage until unit alarms Connect to an external DC power supply capable of delivering 20amps Run unit on 2 0 continuous Starting at 14 volts steadily increase input voltage until unit alarms Run unit on 2 0 continuous using AC power supply Remove dl batteries Remove AC power supply DO NOTIGNORE ALARMS 40 Alarm Name Priority and Type No Breath Alarm Low Priority Physiological Low Battery Alert Low Priority Technical Low Battery Alarm High Priority Technical
20. determine your vehicle s DC power amperage and wattage The device requires 150 watts 15 amps to run at all settings You may require an Inverter with at least a 450 watt capacity This can be purchased through any Auto Service Provider Handle Operation OPEN CLOSE Press buttonto unlock handle Begin rotating and release button Handle will re lockin open close position automatically PULL HANDLE PRESS BUTTON CARRY HANDLE 30 31 CAUTION CAUTION Handling DO NOT LEAN ON UNIT To prevent damage to the unit avoid resting excessive weight on handle STAIRS While transporting the unit down stairs it is recommended to allow Unit to travel down first 32 Accessory Bag The Accessory Bagis designed to carry your Oxlife Independence accessories including batteries AC chargerand cable and DC charger CHARGING ACCESSORIES 2 BATTERIES 33 Cannula Use A Your physician or dealer willrecommend the proper cannula for your use A Use of a cannula not specified for use with oxygen may impairthe performance of your dev ice A DO NOT use cannula tubing longer than 7 feet when using Pulse Flow Mode DO NOT use cannula tubing longer than 50 feet when using Continuous Flow Mode Your physician will prescribe the appropriate cannula for your Use Connect the cannula to the oxygen outlet port asshownon adjacent page The cannula fitting may be tight DO NOT use grease or oils
21. e heard Position the oxygen supply tubing and power cords in a manner that prevents kinking air flow obstructions and tripping hazards To protect dev ice finish it is recommended to use the Oxlife Independence in either an upright position orlying on its back DO NOT operate the device in an enclosed space such as a closet DO NOT locate the Oxlife Independence near any flammable materials or cleaning product orin the direct path of any heat source such asa stove heat register or a carheater Keep the Oxlife Independence atleast 5 feet 1 6m from hot sparking objects or open flame 21 Device Settings Tum the device on by pressing the Power Press the Mode Buttoni to select Continuous or Pulse Flow Mode A Press the Increase or Decrease V buttons to select the correct flow rate Tum the dev ice off by pressing and holding the Power Buttoni OXLIFE INDEPENDENCE 6 6 mL Breath System Status PULSE w FLow ok 0000 PURITY ok CONCEPTS THE PROPER FLOWMODE ANDFLOW RATE AREPRESCRIBEDBY YOUR PHYSICIAN DO CHANGE THESE SETTINGS WITHOUT CONSULTING WITH YOUR PHYSICIAN PULSE FLOW MODE SHOULD ONLY BE USED UNDER THE DIRECTION OF YOUR PHYSICIAN APPROPRIATE AND SAFE PULSE MODE SETTINGS MUST ACCOMMODATE THE INDIVIDUAL PATIENT S LIFESTYLEINCLUDING REST TRAVELAND EXERCISE The device may take up to 3 minutes in order to warm up andreach desired performance 22 CONTINUOUS
22. er off the unit or 15seconds has expired When the voltage from an external power source falls to 11 6 volts or less as measured by the unit internally the screen wil turn amber sound a3 beep sequence separated by 15 seconds of silence and the text ALERT Low Ext Power will flash in the system status window Pushing POWER button once silences the beeping When the voltage from an external power source falls below 10 6 volts as measured by the unit internally the screen wil flash red at 2Hz sound 10 beep sequence repeated after 2 5seconds of silence and the text Low External Power will flash in the system status window The unit will continue to sound until the power button is pressed to silence the audio the power button is held to power off the unit or 15seconds has expired When the voltage from an external power source is above 26 volts as measured by the unit internally the screen wil flash red at 2Hz sounda 10 beep sequerce repeated after 2 5 seconds of silence and the text High External Power will flash in the system status window The unit will continue to sound until the power button is pressed to silence the audio the power button is held to power off the unit or 15seconds has expired If power is removed while the unit is running the unit will sound a 10 beep sequence repeated after 4 seconds of silence Since the poweris removed the display is blank and no backlight color is available
23. ge the screen wil flash red at 2Hz sound a 10 beep sequence repeated after 25 seconds of silence and the text Invalid Motor Temperature wil flash in the system status window The unit will continue to sound until the power button is pressed to silence the audio the power button is held to power off the unit or 15seconds has expired How to Simulate Alarm Run unit in PULSE mode with no cannula connected Unt will automatically trigger alarm and revert to CONTINUOUS mode Run unit in CONTINUOUS mode 2 0 with one low charge battery Unit will alarm with 6 minutes of run time remaining Run unit in CONTINUOUS mode 2 0 with a low charge battery Allow unit to enter battery alert mode then alarm mode Introduce a nitrogen rich stream of gas to the inlet port of the enclosure Oxygen purity should fal when unit is deprived of clean air Introduce a nitrogen rich stream of gas to the inlet port of the enclosure Oxygen purity should fal when unit is deprived of clean air Run the unit in 2 0 Continuous and allow it to warm up Placeacapover the outlet of the unit and wait the appropriate amount of time Remove display circuit board and associated sheet metal Apply heat froma heat gun gradually to thermistor located on board until unit alarms Sensor output can be monitored in engineering mode of device in real time Disconnect the temp wires on the motor hall sensor cable 2 purple wres
24. he device when wet DO NOT use oll grease or petroleum based products on ornearthe device DO NOT use the device with an extension cord e 80 eoo 0000 00 15 Battery and Power Supply Safety Guidelines Use of non approved battery or power supply may cause serious damage to the device and will v oid the warranty Store the battery in a cool dry place when not in use Remove the battery from the device if it will not be used for an extended period of time Locate the extemal power supply in the open air to prevent ov erheating when in use U S Department of Transportation DOT and United Nations UN regulations require that batteries be remov ed from the device when checked asluggage on international flights The battery may explode if exposed to or disposed of in a fire Use only the supplied battery AC and or DC powersupplies that were prov ided with the device Keep the battery away from children Use of a damaged battery or powersupply may cause personal injury DO NOT attempt to disassemble the battery or power supply DO NOT short circuit the battery s metal contacts with metallic objects such as keys or coins It may cause sparks or excessiv e heat DO NOT use the battery or power supply for anything other than its intended purpose DO NOT drop the battery or expose it to mechanical shock DO NOT expose the battery to water or other liquids DO NOT expose the battery to excessiv e heat or cold
25. hen oxygen levels drop below 72 the screen wil flash red at 2Hz sound a 10 beepsequence repeated after 2 5 seconds of silence and the text Low Purity wil flash in the system status window The unit will continue to sound until the power button is pressed to silence the audio the power button is held to power off the unit or 15seconds has expired When the flow of oxygen is stopped for 45 seconds the screen wil flash red at 2Hz sounda 10 beep sequerce repeated after 25 seconds of silence and the text No Flow will flash in the system status window The unit will continue to sound until the power button is pressed to silence the audio the power button is held to power off the unit or 15seconds has expired The maximum operating temperature of the enclosue and pump is 70C and 90C respectively When either of these temperatures are reached the screen wil flash red at 2Hz sound a 10 beepsequence repeated after 2 5 seconds of silence and the text Over Temperature wil flash in the system status window The unit wil continue to sound until the power button is pressed to silence the audio the power button is held to power off the unit or 15seconds has expired When the motor temperature sensor is out of a valid range the screen will flash red at 2Hz sound a 10 beep sequence repeated after 2 5seconds of silence and the text Invalid MotorTemperature will flash in the system status window The unit will continue t
26. iders Alarm Name Priority and Type No Breath Alarm Low Priority Physiological Low Battery Alert Low Priority Technical Low Battery Alarm High Priority Technical Low Purity Alert Low Priority Technical Low Purity Alarm High Priority Technical No Flow Alarm High Priority Technical Over Temperature Alarm High Priority Technical Invalid Motor Temperature High Priority Technical 38 Only Alarm Description When in PULSE mode if a breath is not detected for 45 seconds the screen wil turn amber sound one beep and the text ALERT No Breath will flash in the system status window If no breath is detected for an additional 15 seconds the unit will switch to the previous CONTINUOUS mode setting selected When calculated battery run time reaches 6 minutes remaining the screen wil turn amber sound one beep per 30 seconds and the text ALERT Low Battery wil flash in the system status window Pushing POWER button once silences the beeping When battery power is depleted the pump shuts off the screen wil flash red at 2Hz sounda 10 beep sequence repeated after 25 seconds of silence and the text Low Battery will flash in the system status window The unit will continue to sound until the power button is pressed to silence the audio the power button is held to power off the unit or 15seconds has expired When oxygen levels drop below
27. ifier strap on unit pull it down until tight and buckle the bottom strap Place the humidifier bottle into the front pocket Install The tubing to the top of the humidifier bottle 4 Connect the other end of the tubing to the oxygen output connector on the Oxlife Independence 5 Install the cannula to the output port on the humidifier bottle o he Refer tothe 800 1015 Humidifier Bottle Adapter Assembly Instructions for additional direction descriptions and troubleshooting help 35 Cleaning the Humidifier Note To cleanthe humidifier follow the instructions provided by the manufacturer If none are provided follow these steps l Clean the humidifier daily 2 Washitin soapy water and rinse it witha solution of ten parts water to one part vinegar 3 Rinse thoroughly with hot water Replace the humidifier monthly or as recommended by the manufacturer or your authorized dealer Purchase of humidifier bottle and cannula equipment should be purchased through your oxygen provider O2 Concepts recommends the use of the 7100 0 50 humidifier from Salter Labs or equivalent Firesafe Cannula Valve Intended Use The Firesafe Cannula Valve is a thermal fuse designed to extinguish an oxygen deliverytube fire and stopthe flow of oxygenif the tube is accidentlyignited AN Read Firesafe Cannula Valve Instructions before installing As withall medical equipment attempting to use or install this device without a
28. n point within the battery outline If no other power source is present the screen wil flash red at 2Hz sound a 10 beep sequence repeated after 2 5 seconds of silence and the text Unauthorized Battery will flash in the system status window The unit will continue to sound until the power button is pressed to silence the audio the power button is held to power off the unit or 15seconds has expired When the voltage from an external power source falls to 11 6 volts or less as measured by the unit internally the screen wil turn amber sound a3 beep sequence separated by 15 seconds of silence and the text ALERT Low Ext Power wil flash in the system status window Pushing POWER button once silences the bee ping When the voltage from an external power source falls below 10 6 volts as meosured by the unit internaly the screen will flash red at 2Hz sound a 10 beep sequence repeated after 2 5 seconds of silence and the text Low External Power wil flash in the system status window The unit will continue to sound until tne power button is pressed to silence the audio the power button is held to power off the unit or 15seconds has expired When the voltage from an external power source is above 26 volts as measured by the unit internally the screen wil flash red at 2Hz sound a 10 beep sequence repeated after 2 5 seconds of silence and the text High External Power wil flash in the system status window The unit will
29. nal power source The Oxlife Independence comes equipped with a rechargeable lithium battery that is NOT user serv iceable Battery Charge Statusis also disolayed on the control panel Each bar represents approximately 25 of the total battery charge When the battery is fully charged ov er 90 the battery icon will appear solid The Oxlife Independence battery includes a battery charge status indicator located on the front of the battery Simply press the PUSH button on battery to display the remaining battery life in 25 increments Indicates that there is 75 charge remaining The typical time to recharge a fully discharged battery is approximately 1 5 hours if charging a single battery and 2 5 hours if charging two with the device plugged into AC power and powered off Battery Charge times with the device running will v ary depending on setting used There is no routine maintenance orserv ice to the O2 Concepts rechargeable batteries 25 AC Power Supply Home D Use only the powersupplies provided with this device The AC powersupply charges the battery using a 100 240 volt 50 60 Hertz outlet a typical wall outlet in your home Using the AC powersupply allows you to use your Oxlife Independence while simultaneously recharging the battery Touse the AC powersupply connect the powersupplyto a wall outlet and the Oxlife Independence The external power source icon will be displayed on the control panel Re
30. o sound until the power button is pressed to silence the audio the power button is held to power off the unit or 15seconds has expired Ensure cannula tubing does not exceed 7 feet 2 1m Ensure user breathing through nose and not mouth Note No Breath Detected is used when in Pulse Flow Mode ONLY Plug into an external power source OR Replace depleted battery batteries with a charged battery Plug into an external power source Replace depleted battery batteries with a charged battery Clean or replace air inlet filter Contact your authorized dealer Repair or replace tubing or humidifier Clean or replace air inlet filter Contact your authorized dealer Check cannula connection Repair or replace tubing or humidifier Clean or replace air inlet filler Move device to ensue adequate air flow Contact your authorized dealer Allow the device to reach operating temperature Utilze an alternate source of oxygen if necessary Allow the device to reach operating temperature Utilize an alternate source of oxygen if necessary Allow the device to reach Invalid Box When the internal box temperature sensor is out of a operating temperature 41 High Priority Technical Unauthorized Battery Alert Medium Priority Technical Unauthorized Battery Alarm High Priority Technical Low External Alert Medium Priority Technical Low External Ala
31. rm High Priority Technical High External Power Alarm High Priority Technical No External Power Alarm High Priority Technical valid range the screen will flas beep sequence repeated after 2 5 seconds of silence and the text Invalid Box Temperature will flash in the system status window The unit will continue to sound until the power button is pressed to silence the audio the power button is held to power off the unit or 15seconds has expired If the unit detects that a battery other thanone from O2 Concepts has been installed in the unit the battery icon wil show an exclamation point within the battery outline The unit wil continue to run if on AC DC ora second valid battery is present The screen will turn amber sound beep sequence repeated after 15 seconds of silence and the text Unauthorized Battery wil flash in the system status window Pushing POWER button once silences the beeping If the unit detects that a battery other thanone from O2 Concepts has been installed in the unit the battery icon wil show an exclamation point within the battery outline If no other power source is present the screen wil flash red at 2Hz sound a 10 beep sequence repeated after 2 5 seconds of silence and the text Battery Alarm will flash in the system status window The unit will continue to sound until the power button is pressed to silence the audio the power button is held to pow
32. the exhaust ventslocated on the side ofthe device DO NOTcoverthe device with a towel blanket etc DO NOT drop or insert any objectsor liquid into any opening DO NOT leave your Oxlife Independence or batteries in your v ehicle or trunk Extreme hot or cold may damage your dev ice and or batteries DO NOT ship the Oxlife Independence withthe batteries installed Batteries must be shipped separately and packaged appropriately PP bb bbb gt gt gt 14 Device Safety Guidelines DO NOT SMOKE WHILE USING THIS DEVICE KEEP ALL MATCHES LIT CIGARETTES CAN DLES OR OTHER SOURCES OF IGNITION AT LEAST 10 FEET FROMTHE DEVICE THIS DEVICE PRODUCES ENRICHED OXYGEN GAS WHICH ACCELERATES COMBUSTION Outdoor use must be conducted using battery power Keep unit away from children pets and potential house hold pests Use caution when operating with long power cords or cannulas due to possibility of strangulation from excess length Use caution as small parts may pose a choking hazard Do not remove any parts or fasteners from unit Small parts can cause injury if inhaled or swallowed DO NOT use the dev ice with a damaged power cord or plug DO NOT operate the device on wet surfaces orin standing water and do not submerge or expose to water If the Oxlife Independence has been dropped damaged or exposed to water please contact your authorized dealer for insoection and possible repair of the device DO NOT come in contact with t
33. thorough understanding of its operations and limitations may result in patient oruser injury The deviceisintendedfora life of 4 years from the manufacturing date statedonthe device label The Firesafe Cannula Valve must be used in order to comply with IEC 60601 1 and ISO 8359 36 Refer to Insiructions for Use for Part Number 1109 2017 CE from Applied Home Healthcare Equipment This includes intended use warnings installation instructions cleaning maintenance disposal and device specifications Section 5 User Alerts and Alarms The functionality of the alarm systemis v erified automatically by the Unit upon start up by the unit flashing the various visual display colors and audible indicators There are delays that are greater than 10 seconds inherent to specific alarms and these delays are explainedin detail foreach alarmin the tables below Alarm and Alert Screens OXLIFE INDEPENDENCE 6 0 E mL Breath purse Ay System stats e PURITY ok CONCEPTS ALERTS AND ALARMS WILL BE INDICATED IN THE LOWER RIGHT CORNER OFTHE LCD DISPLAY Red Screens Amber Screens ALERT No External Pow er LOW Purity HIGH EXTERNAL UNAUTHORIZED BATIERY NO Breath LOW OVER ALERT PURITY TEMPERATURE LOW Battery INVALID MOTOR UNAUTHORIZED TEMPERATURE BATIERY LOW BATTERY LOW EXTERNAL POWER 37 INVALID BOX ALERT LOW TEMPERATURE EXTERNAL POWER How to Simulate Alarms and Alerts Prov
34. tteriesfromthe device Re insert the DC power cordinto the device Turn device On using the power button DC Power Supply Troubleshooting Guide for Use Batteries Not Charging Low Battery Alarm Device Alerting Beeping Intermittently Unit Not A Running Low External Power Alarm 29 If There is no charging icon lightning bolt symbol reduce the device setting to O 5LPM Continuous and wait for charging icon to appear Next increase the flowrate by 0 5 increments until desired flowrate is reached Batteries will not charge on settings higher than 2 0 Continuous or 4 0 Pulse If batteries are fully depleted to 0 they may not charge until the device is powered off Batteries mayrequire being charged to 10 order for the lightning bolt to appear on the display To prevent accidental discharge of fully charged batteries batteries canbe removed from the device while running on DC If the DC power drops below 11 5 volts the device will beep If batteries are installed the device will switch battery power The device will automatically return to DC power once the vehicle supplies the proper voltage The device will default to the most reliable source of power To suppl Perform a Reset Reboot There may be too much of a power draw on the vehicles electrical system ie air conditioning radio or GPS Try eliminating these power draws Check your vehicle s user manual or consult an auto technicianto
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