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O2 Concepts, LLC Oxlife Independence, User Manual

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O2 Concepts, LLC Oxlife Independence User Manual Download Page 6

6 

 

Table of Contents 

Table of Contents 

Section 1: Introduction ................................................. 9

 

Symbols Reference ..................................................... 9

 

How to Contact O2 Concepts ............................... 11

 

Specifications ............................................................ 12

 

Indications for Use .................................................... 14

 

Dynamic Network Analysis ...................................... 15

 

Section 2: Safety Guidelines...................................... 16

 

Device Safety Guidelines ........................................ 16

 

Battery and Power Supply Safety Guidelines ....... 18

 

Section 3: Product Description .................................. 19

 

Device and Accessories .......................................... 19

 

Feature Identification ............................................... 20

 

Understanding the Control Panel .......................... 21

 

Applied Parts ............................................................. 22

 

Section 4: Operating Instructions .............................. 23

 

Before Operating ...................................................... 23

 

Locating Your Device .............................................. 24

 

Device Settings ......................................................... 25

 

Pulse Mode Bolus Volumes ...................................... 26

 

Installing and Removing the Battery ..................... 27

 

Typical Battery Operation Times ............................. 27

 

Battery Time Management ..................................... 28

 

Summary of Contents for Oxlife Independence

Page 1: ...B L E O X Y G E N C O N C E N T R A T O R USER READ THIS MANUAL BEFORE OPERATING THIS DEVICE SAVE THIS MANUAL FOR FUTURE REFERENCE DEALER THIS MANUAL MUST BE GIVEN TO THE END USER Oxlife INDEPENDENCE USER MANUAL ...

Page 2: ......

Page 3: ...PROUDLY MADE IN THE U S A ...

Page 4: ......

Page 5: ... USE ACCESSORIES APPROVED BY O2 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 ...

Page 6: ...y Guidelines 16 Battery and Power Supply Safety Guidelines 18 Section 3 Product Description 19 Device and Accessories 19 Feature Identification 20 Understanding the Control Panel 21 Applied Parts 22 Section 4 Operating Instructions 23 Before Operating 23 Locating Your Device 24 Device Settings 25 Pulse Mode Bolus Volumes 26 Installing and Removing the Battery 27 Typical Battery Operation Times 27 ...

Page 7: ...ntering and Exiting Airplane Mode 40 Accessing the Provider Screen and Changing Languages 42 Section 5 User Alerts and Alarms 45 Alarm and Alert Screens 45 Alarm System Test 46 How to Simulate Alarms and Alerts Providers Only 50 How to Respond to Alarms 54 Section 6 Maintenance and Cleaning 58 Maintenance 58 User Care and Cleaning 58 Air Inlet Filter Cleaning 58 Battery Disposal 60 Device Disposal...

Page 8: ...8 NOTES 62 ...

Page 9: ...sehold waste Pulse Mode Keep dry in transport and storage Breath Detect Icon Not suitable for use in the presence of a flammable anesthetic mixture Increase Flow Setting No smoking while using or near device Decrease Flow Setting No open flames Battery Life Indication Date of Manufacture AC DC Power Caution as seen in manual AC DC Charging Indicator Warning as seen in manual ...

Page 10: ... as seen in manual Home as seen in manual The Oxlife Independence protects against solid objects over 12mm and direct sprays of water up to 15 of vertical IEC 60529 Refer to instructions Contains Dynamic Network Analysis DNA technology Class II Equipment ...

Page 11: ...lease call O2 Concepts Technical Support at 1 877 867 4008 for support with your Oxlife Independence Please call Customer Service to report any unexpected operation and events associated with the device Information about the Oxlife Independence and O2 Concepts can also be found on our website at www o2 concepts com ...

Page 12: ...ty values are within 2 of actual values There is no variation in purity within the operating altitude Operating Temperature 50 F 10 C to 104 F 40 C Operating Humidity 10 95 82 4 F 28 C Operating Atmospheric Pressure 101kPa to 63kPa Operating Environment Free of smoke pollutants and fumes Transport Storage Temperature 4 F 20 C to 140 F 60 C Transport Storage Humidity 0 95 non condensing Operating T...

Page 13: ...s 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 temporary interruption in oxygen therapy The availability of an alternate source of supplemental oxygen is strongly recommended in the case of power interruption or a mechanical failure of the...

Page 14: ...tration of supplemental oxygen It is not intended for life support nor does it provide any patient monitoring capabilities Federal law restricts this device to sale by or on the order of a physician No modification of this equipment is allowed There is no know interference posed by ME equipment during specific investigations or treatments There are no known devices that will cause interference iss...

Page 15: ...ce continues to operate within specification The cell must be deactivated prior to flight on a commercial aircraft Instructions for deactivating the cell are listed on page 39 and 40 within the Section Entering and Exiting Airplane Mode Device is FAA approved for use aboard passenger aircraft FAA Advisory Circular 91 21 1B including radio frequency emission limits of RTCA Document DO 160 section 2...

Page 16: ...ual Use of non approved accessories may cause serious damage to the device and will void the warranty Locate oxygen tubing and power cords away from hot surfaces and in a manner to prevent tripping hazards DO NOT operate the device in an enclosed space such as a closet DO NOT block the air inlet or the exhaust vents located on the side of the device DO NOT cover the device with a towel blanket etc...

Page 17: ...rom 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 device with a damaged power cord or plug DO NOT operate the device on wet surfaces or in standing water and do not submerge or expose to water If the Oxlife Independence has been dropped damaged or exposed to water...

Page 18: ...ggage 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 power supplies that were provided with the device Keep the battery away from children Use of a damaged battery or power supply may cause personal injury DO NOT attempt to disassemble the battery or power supply DO NOT short circuit the battery s metal contacts wi...

Page 19: ...ating Instructions The use of certain humidifiers and administration accessories not specified for use with this oxygen concentrator may impair performance Accessories for the Oxlife Independence Battery Battery Shell Blank Desktop Charger Single Bay Desktop Charger Dual Bay Desktop Charger 6 Bay AC Power Supply DC Power Cord Accessory Bag Humidifier Kit 7ft Cannula 50ft Cannula FiresafeTM Cannula...

Page 20: ...ol Panel 2 LCD Display 3 Oxygen Outlet Port 4 Exhaust Port 5 Wheels 6 Rechargeable Battery Slots 7 FAA Approval Identification 8 Pull Handle 9 Air Intake Port Filter 10 External Power Input 11 Handle Lock Release Button 12 Carry Handle ...

Page 21: ...ntrol Panel 13 Power Button 14 Battery Status 15 External Power Source Battery Charging Indicator 16 Increase Up Button 17 Decrease Down Button 18 System Status 19 Breath Detect Pulse Mode Only 20 Mode Setting 21 Mode Button ...

Page 22: ...22 Applied Parts The applied parts or components that a patient will come in contact with during normal operation of the device are listed below 1 Handle 2 Display 3 Oxygen Port ...

Page 23: ...ded 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 are relocating your Oxlife Independence from an extreme environment allow the device to return to the specified operating temperature and humidity ranges before use Operating your device outside of ...

Page 24: ... power cords in a manner that prevents kinking air flow obstructions and tripping hazards To protect device finish it is recommended to use the Oxlife Independence in either an upright position or lying 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 or in the direct path of any heat ...

Page 25: ...ng the Power Button THE PROPER FLOW MODE AND FLOW RATE ARE PRESCRIBED BY YOUR PHYSICIAN DO NOT 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 LIFESTYLE INCLUDING REST TRAVEL AND EXERCISE The device may take up to 3 minutes in ord...

Page 26: ...on the control panel with each breath At higher flow settings you may notice the motor revving which is normal and necessary to achieve maximum oxygen output Pulse Mode Bolus Volumes Pulse Mode Setting Bolus Volume mL 0 5 8 1 0 16 1 5 24 2 0 32 2 5 40 3 0 48 3 5 56 4 0 64 4 5 72 5 0 80 5 5 88 6 0 96 If no breath is detected for 45 seconds the display screen will turn amber and the device will beep...

Page 27: ...ours of Battery Life PULSE FLOW Hours of Battery Life 1 Battery 2 Batteries 1 Battery 2 Batteries 0 5 2hr 53 min 5hr 45min 3hr 8 min 6hr 15min 1 0 2hr 38 min 5hr 15 min 3hr 6hr 1 5 1hr 45 min 3hr 30 min 3hr 6hr 2 0 1hr 15 min 2hr 30 min 2hr 53min 5hr 45min 2 5 1hr 2hr 2hr 23min 4hr 45min 3 0 45 min 1hr 30min 2hr 4hr 3 5 N A 1hr 45min 3hr 30min 4 0 1hr 30 min 3hr 4 5 1hr 15min 2hr 30min 5 0 1hr 8mi...

Page 28: ... total battery charge When the battery is fully charged over 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 The typical time to recharge a fully discharged battery is approximately 1 5 hours if charging ...

Page 29: ...dence The external power icon will be displayed on the control panel Recommendation for Use Use no electrical outlets controlled by a switch When changing power sources wait for the control panel to display the new power icon and unit to beep before removing the original source The detachable power supply cord to the power supply is the means of isolating the unit from the supply mains If the AC p...

Page 30: ...ning before plugging in your Oxlife Independence With the engine running plug in and turn on your device When operating the Oxlife Independence in your vehicle ensure that the device is securely stowed and will not get damaged during transport Ensure that air inlet and exhaust ports are not blocked Batteries will not charge at any setting if the engine is not running DC power is not sufficient to ...

Page 31: ...opping 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 2 When the device is Off disconnect the DC power cord from the vehicle s DC outlet 3 With batteries installed disconnect the DC power cord from device The device will beep once and switch to internal battery power To Reset Reboot 1 With bat...

Page 32: ...vice while running on DC power Device Alerting Beeping Intermittently If the DC power drops equal to or below 11 6 volts the device will beep If batteries are installed the device will switch to 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 supply oxygen Unit Not Running Pe...

Page 33: ...33 Handle Operation OPEN CLOSE Press button to unlock handle Begin rotating and release button Handle will re lock in open close position automatically ...

Page 34: ...34 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 ...

Page 35: ...35 Accessory Bag The Accessory Bag is designed to carry your Oxlife Independence accessories including batteries AC charger and cable and DC charger ...

Page 36: ...onnect the cannula to the oxygen outlet port as shown on adjacent page The cannula fitting may be tight DO NOT use grease or oils to lubricate the oxygen outlet port Read and follow the instructions included with the cannula and follow the instructions given by your authorized dealer Place the cannula over your ears and position the cannula prongs in your nose Clean and replace your cannula regula...

Page 37: ...umidifier is attached Always remove the humidifier before walking DO NOT lay your device down horizontally while attached to a 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 humidifier strap on unit pull it down until tight and buckle the bottom ...

Page 38: ...cepts recommends the use of the 7100 0 50 humidifier from Salter Labs or equivalent FiresafeTM Cannula Valve Intended Use The FiresafeTM Cannula Valve is a thermal fuse designed to extinguish an oxygen delivery tube fire and stop the flow of oxygen if the tube is accidently ignited Read FiresafeTM Cannula Valve Instructions before installing As with all medical equipment attempting to use or insta...

Page 39: ... to Instructions 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 ...

Page 40: ...mode follow the steps listed in the procedure below Step 1 Press and hold both the Up Arrow Button and Down Arrow Button simultaneously in order to enter the Service Mode screen Step 2 Press the Up Arrow Button in order to enter Airplane Mode The mode listed in the upper right corner of the display is the mode that you will be entering ...

Page 41: ...ill exit Airplane Mode after 24 hours have passed or the user manually re enters Normal Mode Press the Up Arrow Button again to enter Normal Mode Step 4 Press the Down Arrow Button in order to exit the service mode screen ...

Page 42: ...and language setting of the unit Within the Provider Screen the language of the device can be changed to six different languages including English German Dutch Spanish French and Italian Entering the Provider Screen Press and hold the Mode Button and Down Arrow Button simultaneously to enter the Provider Screen ...

Page 43: ...ovider Screen the user can change the device language by pressing the Down Arrow Button The current language is displayed in the bottom right corner The language changes each time the Down Arrow Button is pressed in the order shown below ...

Page 44: ...d row on a scale of 0 through 31 ex Sg 31 The cell status is listed in the eighth row ex Cell Connected Voltage In The voltage in is the voltage that the unit is receiving from an external power source such as the AC power supply or DC power supply ex VIN 23 7 where 23 7 is in volts ...

Page 45: ...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 explained in detail for each alarm in the tables below Alarm and Alert Screens Red Screens Amber Screens ...

Page 46: ...ncludes screen color screen flashing sequence and audible alarm sequence Follow the steps in the procedure listed below Step 1 Press and hold both the Up Arrow Button and Down Arrow Button simultaneously in order to enter the Service Mode screen Step 2 Press the Mode Button to test the alarm system ...

Page 47: ...The unit will automatically enter the Medium Priority Alarm test once the High Priority Alarm sequence has concluded Pressing the Mode Button while the High Priority Alarm test is in progress will terminate the High Priority Alarm test and start the Medium Priority Alarm The Medium Priority Alarm consists of a 3 beep sequence separated by 15 seconds of silence and the LCD screen will flash amber ...

Page 48: ...ile the Medium Priority Alarm test is in progress will terminate the Medium Priority Alarm test and start the Low Priority Alarm The Low Priority Alarm consists of 1 beep and a solid amber LCD screen Step 6 The screen will display Test Done after the Alarm System Test has concluded Press the Mode Button once to reset and complete the Alarm Test feature ...

Page 49: ...49 Step 7 Press the Down Arrow Button in order to exit the Service Mode screen ...

Page 50: ... at 2Hz sound a 10 beep sequence repeated after 2 5 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 15 seconds has expired Run unit in CONTINUOUS mode 2 0 with a low charge battery Allow unit to enter battery alert mode then ala...

Page 51: ... gradually to thermistor located on board until unit alarms Sensor output can be monitored in engineering mode of device in real time Invalid Motor Temperature High Priority Technical 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 5 seconds of silence and the text Invalid Motor Temperature will flash in the syste...

Page 52: ...edium Priority Technical When the voltage from an external power source falls to 11 6 volts or less as measured by the unit internally the screen will turn amber sound a 3 beep sequence separated by 15 seconds of silence and the text Low External Power will flash in the system status window Pushing POWER button once silences the beeping Connect to an external DC power supply capable of delivering ...

Page 53: ...nce the audio the power button is held to power off the unit or 15 seconds has expired 20amps Run unit on 2 0 continuous Starting at 14 volts steadily increase input voltage until unit alarms No External Power Alarm High Priority Technical 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 power is removed the display ...

Page 54: ...a 10 beep sequence repeated after 2 5 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 15 seconds has expired Plug into an external power source Replace depleted battery batteries with a charged battery Low Purity Alert Low Prior...

Page 55: ...valid Motor Temperature High Priority Technical 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 5 seconds of silence and the text Invalid Motor 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...

Page 56: ...zed battery and replace with an authorized O2 Concepts battery Low External Power Alert Medium Priority Technical When the voltage from an external power source falls to 11 6 volts or less as measured by the unit internally the screen will turn amber sound a 3 beep sequence separated by 15 seconds of silence and the text Low External Power will flash in the system status window Pushing POWER butto...

Page 57: ...n is pressed to silence the audio the power button is held to power off the unit or 15 seconds has expired Oxlife Independence and use an alternative power source that is within the operating limits No External Power Alarm High Priority Technical 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 power is removed the d...

Page 58: ...able batteries User Care and Cleaning Unplug your Oxlife Independence and or power supplies before cleaning DO NOT use alcohol ethylene chloride or petroleum based cleaners on the case or power supplies Clean the outside case of your device using a soft cloth dampened with a mild detergent and water DO NOT spray or soak the case or front panel Air Inlet Filter Cleaning Regular cleaning of the Air ...

Page 59: ...ent 3 Rinse thoroughly under warm running water 4 Squeeze out excess water 5 It is important to allow the filter to dry completely before reinserting into the device Moisture from a wet or damp Air Inlet Filter may damage your device You may want to keep an extra Air Inlet Filter to use as a replacement while one is drying Contact your authorized dealer for extra Air Inlet Filters AIR INLET FILTER...

Page 60: ...n also contact your local city or town offices for proper disposal instructions for a lithium ion battery Device Disposal This product may contain substances that could be harmful to the environment if disposed of in landfills that are inappropriate Follow local governing ordinances and recycling plans regarding disposal of the device ...

Page 61: ...with the following standards ISO 8359 2nd 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 ...

Page 62: ...62 NOTES ...

Page 63: ...63 ...

Page 64: ...Oxlife INDEPENDENCE O2 Concepts LLC 199 Park Road Extension Middlebury CT 06762 877 867 4008 www o2 concepts com PN 800 1029 Rev B 10 26 2016 ...

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