Activox Portable Oxygen Concentrator User Manual
Contents
1. LifeChoice O breaking boundaries PORTABLE OXYGEN CONCENTRATOR Operator s Manual FOR USE WITH MODELS XYC 100B SPT amp XYC100B PRO Manufactured amp Distributed by InovaLabsNv wl InovaLabsWw Copyright 2014 Inova Labs Inc All rights reserved No part of this document may be reproduced or transmitted in any form or by any means electronic mechanical photocopying recording or otherwise without prior written permission from Inova Labs Inc Inova Labs Inc 3500 Comsouth Drive Suite 100 Austin TX 78744 USA Phone 1 512 617 1700 Toll Free 1 800 220 0977 C Ess je Represented in Europe by QNET BV Hommerterweg 286 6436 AM Amstenrade The Netherlands TABLE OF CONTENTS Introduction 2 Application Indications For Use 2 Symbol Descriptions 3 Warnings 3 Contraindications 4 Adverse Events Hazards 4 Standard Package Contents 5 User Controls 6 Part Names 8 Operating Instructions 9 Battery Life Timetable 12 Carry Case Configuration Instructions 13 Flying With Your POC 13 Operating Procedure 14 Light Indicators Alarms 16 Routine Cleaning and Maintenance 18 service Life 19 Technical Support 19 Disposal 19 Oxygen Concentration Over Altitude and Flow Rate 20 Specifications 20 Accessories 2l Warranty 22 EMC Information 26 INTRODUCTION LI The Operator s Manual will provide familiarity with all models of the LifeChoice Activox Portable Oxygen Concentrator POC and it2. Peoria Ad 85345 5 480 767 4800 p 693 715 8470 fats Ag y D mir p i tl Pai a T a E Po hue A9 296 997 Sales ActiveForever com E 699 915 847 1 LifeChoice O G TM A breaking boundaries af You Follow Us InovaLifeChoice Manufactured amp Distributed by InovaLabsNv 3500 Comsouth Drive Suite 100 Austin Texas 78744 USA 2014 Inova Labs Inc All rights reserved Made in the USA 12M 015 REV B Feb 2014
3. has not been used for a period of one or more days it will automatically re pressurize itself During this time you may hear the compressors running for a few seconds BATTERY LIFE TIMETABLE Pulse Setting Battery Type l LPMeq 2 LPMeq 3 LPMeq Internal sport Model 5 5 Hours 4 Hours 3 25 Hours Battery CN eee Pro Model 12 5 Hours 1 25 Hours 6 25 Hours EaremmeL All Models 3 Hours 3 Hours 2 Hours Battery Based on breaths per minute 12 CARRY CASE CONFIGURATION INSTRUCTIONS BACKPACK 1 Adjust each strap to make sure they are the same length 2 Unfold the snaps that are tucked into the mesh pocket on the backside of the Carry Case 3 Attach one strap to the top left and bottom right snaps on the Carry Case making sure the shoulder pad is near the top clip 4 Attach the second strap to the top right and bottom left snaps on the Carry Case making sure the shoulder strap is near the top clip 5 Forman X with the straps at the top and slide arms into the configuration as if putting on a backpack Assistance may be required with this step 6 Adjust straps as needed Assistance may be required with this step FLYING WITH YOUR POC The LifeChoice Activox POC is approved by the FAA for use on commercial aircraft This approval is listed as a part of the labeling on the bottom panel of the unit Follow the instructions outlined below before traveling with the POC l Fully charge the Internal and if pur
4. provider may determine the device must be sent in for service The corresponding alarm triggered by an internal component at the end of its service life is listed below Component Alarm Triggered sieve Bed Low Oxygen or Service Alarm Compressor Low Oxygen Low Pressure or Service Alarm Should your device alarm for service see Alarm Table on page 17 switch to another source of oxygen and contact your equipment provider TECHNICAL SUPPORT Please contact the local medical equipment company that provided or sold you the POC for any technical or emergency support If any additional information is needed please contact Inova Labs Customer Care Team toll free at 1 800 220 0977 or 1 512 617 1700 DISPOSAL Inova Labs expects end users to dispose of the POC in an environmentally friendly way and in accordance with local laws and regulations Electrical and electronic equipment is labeled with the crossed out wheeled bin symbol indicating that the equipment should be disposed of by the end user separate from other types of waste The POC device contains lithium ion batteries and end users should contact Inova Labs or their local distributor for disposal collection and recycling options and terms and conditions for their country In 2002 the European Union introduced the Directive on Waste Electrical and Electronic Equipment WEEE The main aim of the Directive is to ensure that WEEE is collected and treated separately WEEE ite
5. reference the Carry Case Configuration Instructions FOLLOW THESE STEPS BEFORE FIRST USE l Charge the POC before initial use The Pro Model can take up to 4 5 hours to fully charge and the Sport Model can take up to 3 hours Begin charging by connecting the AC Adapter to the unit and charger end to an electrical outlet 2 Verify that the Battery Check LED labeled INT is solid green and the Power LED is flashing green This indicates that the system recognizes the external power source and is charging the Internal Battery If an external battery was purchased connect it to the External Battery Port By design the External Battery will begin charging after the Internal Battery has reached a full charge It can take up to 3 hours to fully charge the External Battery CAUTION Never use an external battery that is not authorized by Inova Labs Inc DO NOT dismantle open or shred secondary cells or batteries DO NOT expose cells or batteries to heat or fire Avoid storage in direct sunlight 3 Connect the nasal cannula securely to the POC cannula nozzle fitting POWERING THE LIFECHOICE ACTIVOX POC The POC can be powered in four different ways 1 Internal Battery 2 AC Adapter Charger 3 DC Adapter Charger 4 External Battery optional sold separately from the Standard Package The rechargeable batteries are maintenance free and can only be purchased at the factory or through an authorized repair facility l Int
6. 0MHz 2 5GHz d 2 33 VP 800MHz to 2 5GHz Where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol a NOTE 1 At 80MHz and 800MHz 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 Model XYC 100B SPT XYC100B PRO is to be used exceeds the applicable RF compliance level above the Model XYC100B SPT XYC100B PRO should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as re orienting or relocating the Model XYC100B SPT XYC 100B PRO b
7. AUTOMODE o D W POC is functioning SLEEP LOW ee CHECK eu battery mp aie normally eto POC powered ei mono o MU io POC is functioning by external coon oj IQ a normally battery Green LED light labeled EXT flashes slowly ALARM INDICATORS Audible PEN Problem Light Indication Action Alert PULSE SETTING m OO Check cannula No breath connection Breathe detected by Intermit Ten MA o m aan through nose and the unit for tent beep Ee CHECK 50 alarm will shut off approximately If alarm persists 15 seconds contact your Amber Alarm LED light flashes provider PULSE polis fao Low Battery Single orcs O K Cs Pos Connect the POC to Alarm loud long a e MUA 100 ACTIVE HIGH BATTERY 75 Approximately beep SLEEPLOW Eo CHECK S an external power 10 minutes of every 60 source battery power seconds Amber Battery Check LED labeled INT flashes slowly Critical y Low Battery Fast es Alarm audible AUTOMODE e MTA i 10 Connect the POC to Approximately beep PE ayy Seas soi an external power 30 seconds of Unit shuts source battery power down Amber Battery Check LED labeled INT begins flashing quickly PULSE SETTING Critical High Fast fo OD Ce E Change to another Temperature audible A C arm source of oxygen Alarm beep seer 75 Ten while allowing the Unit is Unit shuts _ unit to cool overheating down Amber Alarm LE
8. D light flashes until unit cools M Pina Turn off the unit O G Ca Cs Change to another Low Oxygen Continu source of AUTOMODE MUE foo service Alarm ous audi Co iia CEN a Pon oxygen and contact ble alarm your equipment provider Alarm LED is solid Amber Switch to another DON source of oxygen Single O O amp O Check the power AC Power audible T A o peit supply If an issue Interruption beep for 2 ee ciao Eo CHECK eo Pron is found solve as seconds appropriate If no issue was found 17 All LEDs off contact your provider 18 ROUTINE CLEANING AND MAINTENANCE The LifeChoice Activox POC was designed to minimize the amount of routine maintenance that is required The device does not have any end user repairable parts Aside from the preventative maintenance outlined below all other maintenance required must be performed by qualified personnel Fan Inlet Vent Cleaning There is one inlet vent located on the right side facing the unit of the POC The carrying case for the unit has mesh material corresponding to the location of the Fan Inlet Vent You should visually check the carrying case to ensure that there is no buildup of lint hair or other materials that could obstruct the flow of air into the unit s fan inlet vent Remove any material buildup using a soft brush At least once a month inspect the grille of the intake vent and ifit appears dirty use a dry cotton swab Q Tip
9. O is intended for use in the electromagnetic environment specified below The customer or the user of the Model XYC 100B SPT XYC100B PRO should assure that it is used in such an environment IEC 60601 Test Level Immunity Test Compliance Level Electrostatic 6 kV contact 6 kV contact Discharge ESD IEC 61000 4 2 8 kV air 8 kV air 2 kV for power supply lines 2 kV for power Electrical Fast supply lines Transient Burst IEC 61000 4 4 Not applicable 1kV for input output lines 1 kV line to line 1 kV Surge line to line line to earth 2 kV line to earth lt 5 Ur lt 5 Ur gt 95 dip in Ur gt 95 dip in Ur for 0 5 cycle for 0 5 cycle Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 40 Ur 60 dip in Ur for 5 cycles 40 Up 60 dip in Ur for 5 cycles 10 Ur 80 dip in Ur for 25 cycles 10 Up 80 dip in Ur for 25 cycles lt 5 Ur gt 95 dip in Ur gt 95 dip in Urp lt 5 Uy for 5 seconds for 5 seconds Power Frequency 50 60Hz Magnetic Field IEC 61000 4 8 3 A m Flectromagnetic Environment Guidance Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Mains power quality should be that of a typical commercial or hospital environment Mains power quality sh
10. Operational Humidity Range 15 to 93 Non condensing Storage Temperature Range 32 F to 140 F 0 C to 60 C Storage Humidity Range 15 to 93 Non condensing Operational Altitude Max 10 000 ft 3 048 m or 10 1 PSIA 522 mmHg When powered by the external AC adapter external DC adapter or external or internal battery Performance degradation may occur at high altitude ACCESSORIES ADDITIONAL REPLACEMENT SPARE 4 Way Carry Case Comes complete with adjustable strap system that allows case to be used as a backpack shoulder strap waist strap or carried as a briefcase Included with purchase of LifeChoice Activox POC Product Number XYC105B AC Adapter Charger 10 ft 8 m Used to charge and run the POC simultaneously Included with purchase of LifeChoice Activox POC Product Number XYC103 DC Adapter Charger 6 ft 1 8 m Used to charge and run the POC simultaneously For use at home or in the car RV motor boat etc Included with purchase of LifeChoice Activox POC Product Number XYC 104 Standard 7 ft 2 m Long Single Lumen Nasal Cannula7y Included with purchase of LifeChoice Activox POC Product Number XYC262 Accessory Bag Included with purchase of LifeChoice Activox POC Product Number XYC340 External Battery Not included with purchase of LifeChoice Activox POC Standard Package Product Number 200122 Accessories adapters and cables other than those specified with the exception of adap
11. Over the frequency range 150kHz to 80MHz field strengths should be less than 3 V m al EMC INFORMATION continued Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and The LifeChoice Activox Portable Oxygen Concentrator Model XYC100B SPT XYC100B PRO The LifeChoice Activox Portable Oxygen Concentrator Model XYC100B SPT XYC100B PRO is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the Model XYC100B SPT XYC100B PRO can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the Model XYC 100B SPT XYC 100B PRO as recommended below according to the maximum output power of the communications equipment Separation Distance According to the Frequency of Transmitter m Rated Maximum Output Power of 150kHz to 80MHz 80MHzto 800MHz 800MHz to 2 5GHz 1 17 VP 1 17 P 2 P Transmitter W i y d y d 2 33 v 0 01 0 12 0 12 0 23 0 1 0 37 0 37 0 74 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters 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 80MHz and 800MHz the separ
12. ROLS Control Panel Battery Charge Indicator Pulse Setting PULSE SETTING Control Buttons eittox CD e a I 2 3 LPMeq p l gaa Alarm Indicator AUTO MODE Nia oe Power Button i ee ATER creas _ For use by Auto Mode trained service Indicators Mute Button INT amp EXT Battery Check personnel only Indicators Button Indicator Lights Colored LED lights indicate either a change in operating status or a condition that may need response alarm Audible Signals An audible signal beep indicates either a change in operating status or a condition that may need response alarm Audio response will vary among users depending upon hearing abilities Pulse Setting Control Buttons There are three individual Pulse setting Control Buttons on the Control Panel 1 2 and 3 which reference oxygen flow Use the setting prescribed by your doctor Power Button To turn the LifeChoice Activox POC on or off press the Power Button Auto Mode Indicators There are two inhalation sensitivity modes on the control panel Active High and Sleep Low which automatically adjust based on oxygen demand e g breathing patterns requirements Reference Control Panel diagram Mute Button The POC features a mute function to disable audible alarms during operation Ifan alarm has been muted the amber Mute Button LED will be illuminated Reference Control Panel diagram A CAUTION Please use this function appropriately as it silences im
13. S OF USE AND LOST REVENUE REGARDLESS OF THE WARRANTY FORM OF THE CLAIM WHETHERIN CONTRACT TORT NEGLIGENCE STRICT LIABILITY OR OTHERWISE ARISING OUT OF OR RELATING TO INOVA LABS ITEMS MATERIALS AND OR SERVICES AND EVEN IF INOVA LABS HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES TO THE FULLEST EXTENT PERMITTED BY APPLICABLE LAW INOVA LABS LIABILITY HEREUNDER OR RELATING HERETO SHALL NOT EXCEED THE PURCHASE PRICE PAID FOR THE ITEMS REGARDLESS OF THE FORUM AND REGARDLESS OF WHETHER ANY ACTION OR CLAIM IS BASED ON CONTRACT TORT NEGLIGENCE STRICT LIABILITY OR OTHERWISE PURCHASER AGREES AND ACKNOWLEDGES THAT THE ITEMS ARE OF A SIZE DESIGN AND CAPACITY SELECTED BY ITS MEDICAL PROVIDER Basis of Bargain PURCHASER ACCEPTS THESE DISCLAIMERS OF WARRANTIES AND LIMITATIONS OF LIABILITY CONTAINED HEREIN AS PART OF A BARGAIN WITH RESPECT TO THE PRICING OF THE ITEMS AND UNDERSTANDS THAT THE PRICING WOULD LIKELY BE HIGHER IF INOVA LABS WERE REQUIRED TO BEAR LIABILITY IN EXCESS OF THAT STATED HEREIN ALL OF THE LIMITATIONS AND DISCLAIMERS SET FORTH HEREIN SHALL APPLY NOTWITHSTANDING THE FAILURE OF THE ESSENTIAL PURPOSE OF ANY LIMITED REMEDY Governing Law and Jurisdiction The rights and obligations of the parties pursuant to this Limited Warranty and any dispute arising hereunder shall be governed by and interpreted in accordance with the internal but not the conflicts laws of the State of Texas USA The 1980 U N Convention
14. URCHASER S EXCLUSIVE REMEDY AND INOVA LABS SOLE OBLIGATION HEREUNDER SHALL BE LIMITED TO REPAIR OR REPLACEMENT OF THE DEFECTIVE ITEM OR REFUND OF THE APPLICABLE PURCHASE PRICE AT INOVA LABS OPTION Inova Lab s warranty obligations hereunder are conditioned upon Purchaser s compliance with the warranty procedures set forth herein If an Item fails continued 23 WARRANTY a4 continued to conform to the Limited Warranty set forth herein Purchaser must give prompt written notice to Inova Labs with such notice in no event beyond the applicable warranty period at which time Inova Labs or its authorized distributor will issue a Return Material Authorization RMA number All Items claimed to be defective within the warranty period shall be properly packaged and shipped on a prepaid basis to Inova Labs USA sales or its authorized distributor at Purchaser s expense The exterior of the shipping container must clearly display the RMA number which properly identifies returned Items and the Item must be packaged together with proof of Date of Purchase Items returned without a proper RMA number and proof of the Date of Purchase shall be refused and returned to Purchaser at Purchaser s expense All returned Items are subject to warranty confirmation by Inova Labs Inova Labs shall pay for standard shipment back to Purchaser for repair or replacement of Items properly covered under this Limited Warranty When repairing or
15. ation distance for the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Guidance and Manufacturer s Declaration Electromagnetic Emissions The LifeChoice Activox Portable Oxygen Concentrator Model XYC100B SPT XYC100B PRO is intended for use in the electromagnetic environment specified below The customer or the user of the Model XYC100B SPT XYC100B PRO should assure that it is used in such an environment Emissions Test Compliance Electromagnetic Environment Guidance The Model XYC100B SPT XYC100B PRO uses RF energy only for its internal function Therefore its RF RF Emissions CISPR 11 Group emissions are very low and are not likely to cause any interference to nearby electronic equipment RF Emissions CISPR 11 ClassB The Model XYC100B SPT XYC100B PRO is H aaa suitable for use in all establishments including Pca 0 ar tae ClassA domestic establishments and those directly connected to the public low voltage power supply Voltage Fluctuations Flicker l network that supplies buildings used for domestic ae Emissions IEC 61000 3 3 COMpPles purposes 29 T I f y IMPROVING OUTCOMES IMPROVING LIVES Scottsdale www ActiveForever com Peoria 10799 N 20th Street ws 9299 W Olive Avenue Scottsdale AT 85240 q a 00 37 f 803 3 Suite 604
16. button to check the charging process 4 When the Internal Battery is fully charged the INT Battery Check LED will turn off NOTE The charge indicator will show 4 solid green lights when the battery has a charge level of 96 percent or more When the battery reaches a full 100 percent charge the INT LED will turn off 5 It is recommended to recharge the Internal Battery even if only partially depleted as often as possible The Internal Battery cannot be overcharged so it is okay to leave it plugged in via an AC or DC Adapter Charger continuously EXTERNAL BATTERY CHARGING 1 Connect the External Battery to the External Battery Port on the POC Then connect the unit to either an AC or DC Adapter and corresponding charger to a suitable outlet To prolong battery life and maintain communication with the POC it is recommended to charge the External Battery when you charge the POC s Internal Battery 2 Verify that the Battery Check LED labeled EXT is solid green and the Power LED is flashing green J This indicates that an external power source is recognized and the battery is charging NOTE By design the Internal Battery will charge first That means that the External Battery will not start charging until the Internal Battery reaches a 100 percent charge level Use the INT and EXT Battery Check LEDs to determine which batteries are charging 3 It takes up to 3 hours for a fully discharged External Battery
17. cell leaking do not allow the liquid to come in contact with the skin or eyes If contact has been made wash the affected area with copious amounts of water and seek medical advice CONTRAINDICATIONS l 2 3 4 The device is not intended to be life sustaining or life supporting In certain circumstances oxygen therapy can be hazardous Please seek medical advice before using this device The device is designed to provide a flow of high purity oxygen up to 3 LPMeq pulse The device should only be used by patients prescribed oxygen therapy within this range As the device will alarm through audio and visual indicators patients who are unable to communicate discomfort hear see and or understand the alarms may require additional monitoring ADVERSE EVENTS HAZARDS Inova Labs Inc assumes no liability for persons choosing not to adhere to manufacturer s recommendations Failure to adhere to the statements below may impair performance of the device and will void all warranties Q DO NOT use power supplies or accessories other than those that IT 3 DO NOT use oil grease or petroleum based products on or near the device as the use of such products may damage the electronic components of the device and will void all warranties came with the device as the use of non specified accessories may impair performance and void all warranties DO NOT allow smoking or open flames within 10 ft 3 m of the device as th
18. chased External battery within 24 hours of a trip 2 Pack all required accessories AC and DC Adapter Charger Operator s Manual etc 3 Download and complete the Physician Statement from InovaLabs com Resources Bring the signed and completed Physician Statement to the airport and be ready to provide it to the airline if requested The POC is FAA approved for air travel The required FAA label location is on the bottom of the POC The FAA approved POC list shows Inova Labs LifeChoice Activox Every airline has specific information required for traveling with oxygen Before traveling review your airline s specific requirements XYC100B LifeChoice Activox The Nether Authorized by FAA for use onboard seers Sameer sn aircraft 14CFR Part 121 SFAR 106 O S eee Portable Oxygen Concentrator O 90 3 1 3 LPMeq Input 19V Output 6 A Qty 1 dii y NOTE Airlines may have specific requirements for traveling with oxygen Before traveling notify your airline that you will be traveling with an approved POC 13 OPERATING PROCEDURE 1 Locate and position the POC so that the Fan Inlet Vent and Fan Outlet Vent are not obstructed The unit particularly the air inlet slots and the air outlet areas should be positioned in a well ventilated space 2 Power the POC using one of the four modes described in the Powering the LifeChoice Activox POC section A p 3 Press the Powe
19. e device produces enriched oxygen gas which accelerates combustion DO NOT operate the device in the accessory bag or any other enclosed bag as improper ventilation will impair performance and void all warranties DO NOT submerge or expose the device to liquids as it may damage the electronic components of the device and will void all warranties DO NOT operate or expose the device to temperatures and humidity levels outside of the specified operational environment conditions listed in the Specifications section on page 20 Extreme temperatures and humidity levels may damage the device and void all warranties DO NOT press the control panel buttons with any hard sharp and or small object as it may damage the control and will void all warranties STANDARD PACKAGE CONTENTS LifeChoice Activox POC Ac Power Adapter 4 Way Carry Case Use as a backpack shoulder O DC Power Adapter strap waist pack or briefcase Adjustable Straps Standard 7 Foot 2 meter Long For use with 4 Way Carry Case Single Lumen Nasal Cannulat External Battery O Accessory Bag Model identified on unit and packaging labels See REF An optional External Battery is available for purchase which provides up to 3 hours of additional battery time Reference Battery Life table as battery life will vary depending upon model breath rate and Pulse Setting Nasal cannula may not be included Based on international requirements USER CONT
20. en concentrator may impair the performance Reference Alarm Indicators Table for explanation of low battery alarms t Nasal cannula may not be included Based on international requirements PART NAMES Nozzle Fitting _ Fan Inlet Vent Control Panel Fan Outlet ee Vent External Battery Port FAA Approval Sticker located on bottom Cannula Nozzle Fitting The Nasal Cannula connects to the oxygen output nozzle at the top of the POC DO NOT place the cannula into nasal passages until the POC is fully powered on Breathing through the Cannula during start up may prevent the system from powering on Control Panel All user controls are located on this panel See User Controls section on page 6 for details Fan Inlet Vent Cooling air is drawn in through this opening See Maintenance section for cleaning instructions Fan Outlet Vent Processed air is exhausted through this opening External Battery Port Connect the External Battery if purchased to this port This connection is to be used solely with the specified external battery Precaution Please pay attention to the orientation of the connector Wrong alignment could cause damage to the connector FAA Approval Sticker Located on the bottom of the unit OPERATING INSTRUCTIONS The LifeChoice Activox POC is recommended and designed to be operated and stored in its carry case at all times To configure the carry case as a backpack please
21. ernal Battery A rechargeable internal battery is located within each POC unit Reference Battery Life Timetable as battery life will vary depending upon model breath rate and Pulse Setting When the POC is being powered from the Internal Battery the Battery Check LED labeled INT will slowly flash Pushing the Battery Check Button will display the charge level of the Internal Battery If not connected to the AC or DC Adapter Charger the Internal Battery will slowly discharge over time even when not in use Always check the battery level prior to use to ensure adequate charge level OPERATING INSTRUCTIONS continued 2 ACAdapter Charger An AC Adapter Charger allows the POC to be powered froma standard 100 240 VAC 50 60 Hz outlet When the unit is operated from an AC Adapter Charger power from the AC outlet powers the unit and recharges the internal and or External Battery See Battery Charging section for details Using an AC Adapter Charger that is not specified by Inova Labs with the POC may damage the unit and will void all warranties 3 DC Adapter Charger A DC Adapter Charger can be connected from the POC unit to a vehicle s car boat motor home etc standard 12 VDC outlet When the system is connected to the DC outlet power from the vehicle battery powers the POC unit and recharges the Internal and or External Battery See Battery Charging section for details NOTE The 12 VDC outlets
22. ice for one 1 year from the Date of Purchase for Sieve Beds on portable oxygen concentrators POC Accessories and Batteries are warranted to Purchaser solely to be free of defects for one 1 year from the Date of Purchase for Accessories and Batteries Refer to the table below for a detailed description of the relevant timeframes under this Limited Warranty Product components which include the Outer Shell Control Panel Compressors Computer Controller amp Power Boards and PSA Lung Assembly Sieve Beds Accessories and Batteries are collectively referred to as Items ITEM LENGTH OF COVERAGE Outer Shell POC Housing 3 Years Control Panel POC Keypad 3 Years Compressors 3 Years Computer Controller amp Power Boards 3 Years PSA Lung Assembly 3 Years Sieve Bed l Year Battery Internal l Year Battery External Supplemental l Year Accessories l Year WARRANTY The Limited Warranty extends only to the Purchaser and is not transferable unless otherwise expressly agreed to in writing by Inova Labs Inova Labs oxygen concentrators produce enriched oxygen gas which accelerates combustion DO NOT ALLOW SMOKING OR OPEN FLAMES within ten 10 feet three 3 meters of these devices while in use A user s SMOKING of any kind including cigarette cigar and pipe while using Product and evidence that a user has smoked while using the Product will void all warranties with respect to that Product and related Ite
23. in some pre 2000 model cars will not provide sufficient current to operate the POC and charge the battery at the same time Verify that a DC outlet can provide at least 10 amps at 12 VDC Car auxiliary power varies significantly therefore the rate of charging will vary It is recommended that the vehicle be turned on before plugging the DC Adapter Charger into the POC 4 External Battery To power the POC from an external battery connect the External Battery to the External Battery Port A fully charged external battery will supply power to the POC for up to three hours Reference Battery Life Timetable as battery life will vary depending upon model breath rate and Pulse Setting When the POC is being powered from the External Battery the Battery Check LED labeled EXT will be slowly flashing Pushing the Battery Check Button will display the charge level of the External Battery INTERNAL BATTERY CHARGING l Connect the unit to either an AC or DC Adapter and corresponding charger to a suitable outlet 2 With the unit powered off verify that the INT Battery Check LED is solid green and the Power LED is flashing green This indicates that an external 10 power source is recognized and the battery is charging OPERATING INSTRUCTIONS continued 3 It can take a fully discharged Internal Battery up to 4 5 hours with the Pro Model or 3 hours with the Sport Model to reach a 100 percent charge level Press the Battery Check
24. ms An extended warranty on the Product is available at a maximum of two 2 additional years and must be purchased at the time of the original Date of Purchase An extended warranty on the Product covers the same Product components as the limited three 3 year warranty refer to chart above and is added on to the original warranty which runs from the Date of Purchase The timeframe for Sieve Bed replacement remains at one 1 year for POCs while Batteries and Accessories remain at one 1 year Extended warranties are offered to the original Purchaser only and are non transferrable unless otherwise expressly agreed to in writing by Inova Labs The Limited Warranty excludes from coverage any damage failure or malfunction caused by or related to a Abuse misuse negligence or accident b Failure to comply with instructions contained in the Operator s Manual c Alteration tampering or modification by someone other than an authorized Inova Labs representative d Unauthorized repairs or alterations Environmental conditions including but not limited to water flame chemicals fumes in the Atmosphere extreme heat or cold food or liquid sand dirt or the like Lack of regular preventive maintenance and cleaning Damage in shipment to Inova Labs Other acts beyond the reasonable control of Inova Labs and Any damage caused by improper packaging when returning Items to Inova Labs D Warranty Service and Coverage P
25. ms may contain hazardous substances that should not end up in the human environment and can have adverse effects on it if they do 20 OXYGEN CONCENTRATION OVER ALTITUDE AND FLOW RATE Oxygen Concentration Over Altitude Range 0 4000 m Oxygen 95 90 85 80 1 LPMeq 2 LPMeq 3 LPMeq Flow Rate SPECIFICATIONS For all Models unless specified Device Electrical Classification Class II Type BF Weight Sport Model 3 9 lbs 1 7 kg Pro Model 4 3 lbs 1 9 kg Dimensions 9 05 w x 7 875 hx 4 38 d 22 98 cm w x 20 00 cmh x 11 12 cmd Mode of Operation Stationary Portable Flow Control Pulse Settings 1 2 amp 3 LPMeq Oxygen Concentration 90 3 Oxygen Concentration Sensor Alarm 85 or less Maximum Outlet Pressure 16 psi 110 kPa 10 Average Sound Level At 2 LPMegd 46 dB at 10 ft 8 m Approximate Internal Battery Duration See Battery Life Timetable on page 13 Approximate Internal Battery Recharge Time Sport Model 3 Hours Pro Model 4 5 hours Power Supply AC 100 to 240 VAC 50 to 60 Hz DC 11 to 16 VDC or Battery 12 tol6 8 VDC LifeChoice Activox POC Input 19VDC 6A External AC Power Adapter Charger Input 100 240VAC 50 60 Hz Output 19VAC 6 3A External DC Power Adapter Charger Input 11 16VDC 10A Output lOVAC 6 3A Nasal Cannula 7 ft 2 m maximum Environmental Conditions for Use Storage and Transport Operational Temperature Range 41 F to 104 F 5 C to 40 C
26. on Contracts for the International Sale of Goods shall not apply If any provision of this Limited Warranty is inconsistent with applicable laws relating to Purchaser Purchaser agrees to waive any and all rights and remedies it may have under such laws to the extent it may waive such rights and remedies This Limited Warranty is offered as an additional benefit to Purchaser s statutory rights and it does not affect such statutory rights in any way The parties agree and consent that the state or federal courts in Texas shall have exclusive jurisdiction with respect to any dispute arising out of or relating to this Limited Warranty If any provision of this Limited Warranty is held to be illegal or unenforceable that provision will be limited or eliminated to the minimum extent necessary so that this Limited Warranty will otherwise remain in full force and effect and enforceable EACH PARTY EXPRESSLY WAIVES ALL RIGHTS TO A TRIAL BY JURY Technical Support Inova Labs Customer Care Team can be reached Monday Friday 8 00AM 5 00PM CST at 1 512 617 1700 continued 25 26 EMC INFORMATION Medical electrical equipment needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in the accompanying tables Guidance and Manufacturer s Declaration Electromagnetic Immunity The LifeChoice Activox Portable Oxygen Concentrator Model XYC100B SPT XYC100B PR
27. or similar to clean it Never use alcohol solvents or petroleum distillates for cleaning Unit and Carrying Case Cleaning If it is necessary to clean the unit and or carrying case use only warm water and a mild liquid dish detergent Dampen a cloth in the solution and carefully wipe the outside surfaces of the unit and or carrying case CAUTION DO NOT use alcohol solvents polishes or any oily substances since they may be flammable Nasal Cannula Inspection At least once a week visually inspect the nasal cannula Make sure there are no kinks or obstructions Replace as needed with a standard 7 ft 2 m single lumen nasal cannula from your local medical equipment supplier Reserve Oxygen Supply Your equipment provider should provide or suggest an alternative source of supplemental oxygen therapy in case there is a mechanical failure or power outage Hour Meter The Hour Meter function is for use by trained service personnel only SERVICE LIFE This section outlines the defined service life of the LifeChoice Activox POC s components The service life of these components is dependent on operating and environmental conditions Daily use of the unit may actually extend the replacement time for some of these items It is recommended that the device be powered on and run for a few hours if itis has not been used on a daily basis Should your device indicate an alarm that requires you to contact your equipment provider the
28. ould be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment If the user of the Model XYC100B SPT XYC100B PRO requires continued operation during power mains interruptions it is recommended that the Model XYC100B SPT XYC100B PRO be powered from an uninterruptible power supply or a battery Power frequency magnetic fields should be at levels characteristic of a typical commercial or hospital environment NOTE Ur is the a c mains voltage prior to application of the test level Guidance and Manufacturer s Declaration Electromagnetic Immunity The LifeChoice Activox Portable Oxygen Concentrator Model XYC100B SPT XYC100B PRO is intended for use in the electromagnetic environment specified below The customer or the user of the Model XYC100B SPT XYC100B PRO should assure that it is used in such an environment Immunity Test IEC 60601 Compliance Electromagnetic Test Level Level Environment Guidance Portable and Mobile RF communications equipment should be used no closer to any part of the Model XYC 100B SPT XYC 100B PRO including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended Separation Distance Conducted RF 3 Vrms 3V d 1 17 VP IEC 61000 4 6 150kHz 80MHz d 1 17 VP 80MHz to 800MHz Radiated RF 3 V m 3 V m IEC 61000 4 3 8
29. oxygen is delivered PULSE gt aig 100 TS Place the nasal cannula in the nasal passages and breathe normally When the POC senses inhalation oxygen is supplied through the cannula The duration and size of the pulse is dependent upon the Pulse Setting selected d Se Check to make sure your unit s lt gt battery is fully charged before venturing out with the POC for 4 BATTERY the first time See Battery Charge Indicator section User Controls To turn the POC off press the Power Button and hold for 2 seconds until the green Power LED goes off and the unit shuts down After the POC is powered off the internal fans may continue to operate for an additional period of time until the temperature inside the unit is sufficiently cooled 15 16 LIGHT INDICATORS ALARMS NORMAL OPERATION INDICATORS Normal Audible Operation Alert Light Indication PULSE ale NG Brief You may begin to POC turned audible use the POC unit in on tone 3 minutes Green LEDs of Power Active High and Pulse Setting 1 are illuminated NOTE After the initial power on the Pulse Setting LED corresponding to the last flow rate used will illuminate POC has PULSE cous MASLO detected an eaaa inhalation breath and z2 O Gees m POC is functioning is delivering e normally a pulse of SENEN Green LED of selected Pulse Setting flashes with each breath w PVE POC powered 3 ee by internal ee
30. portant audio signals regarding the status of the POC INT and EXT Indicators These LED lights will indicate which power source the unit is using or charging The INT LED represents the Internal Battery while the EXT LED represents the External Battery Battery Check Button Displays the battery charge level of the internal and if connected external battery Battery Charge Indicator The Battery Charge Indicator consists of four LEDs labeled 25 50 75 and 100 Battery Check LED Charge Level 25 LED 50 LED 15 LED 100 LED 0 13 25 38 50 63 75 NOTE Charge level indication is approximate The charge indicator will show 4 solid green lights when the battery has a charge level of 96 percent or more When the battery reaches a full 100 percent charge the INT or EXT if connected LEDs will turn off Hour Meter Button The POC will read and display the number of hours that the unit has been used Refer to Routine Maintenance section Nasal Cannula A standard single lumen nasal cannula or equivalent must be used with the POC to provide oxygen from the concentrator Astandard single lumen cannula 7 foot 2 meter is recommended for use For a replacement cannula please contact your local medical equipment supplier Follow cleaning and care instructions provided with the nasal cannula CAUTION Use of some administration accessories not specified for use with this oxyg
31. r Button once to turn the unit on An audible beep will sound and the Power LED the Auto Mode Active High LED and the Pulse Setting of 1 LED will flash il green This indicates that the POC is powered on ready for use and the settings may now be changed Pressing the Power Button for an extended time after the audible beep will cause the system to turn off NOTE After powering on the POC allow 3 minutes for the unit to reach stated performance After initial power on the Pulse Setting LED corresponding to the last flow rate used will illuminate CAUTION DO NOT place the cannula into nasal passages until the POC has fully powered on Breathing through the cannula during start up may prevent the system from powering on 4 There are 2 inhalation sensitivity modes on the control panel Active High and Sleep Low which automatically adjust based on oxygen demand e g breathing pattern requirements No action is required to start the delivery of oxygen AUTO MODE ACTIVE HIGH a EP LOW 14 select a Pulse Setting of 1 2 or 3 as prescribed by your doctor The device utilizes PULSE WAVE Delivery which delivers oxygen congruent with your inhalation rate Because this type of delivery is very gentle you may not feel the pulse of oxygen To verify that oxygen is being delivered reference the LED above your selected Pulse Setting This LED will flash every time a breath is detected and a bolus of
32. replacing the Item Inova Labs may use functionally equivalent products or parts that are new equivalent to new or refurbished All parts removed in the replacement of any Item shall become the property of Inova Labs To the full extent permitted under applicable law the warranty coverage will not be extended or renewed or otherwise affected due to Inova Labs authorized repair or replacement However part s repaired or replacement Items will be warranted for the unexpired portion of the original Limited Warranty Disclaimer of Warranties NO REPRESENTATIVE OF INOVA LABS HAS AUTHORITY TO MAKE ANY REPRESENTATIONS OR PROMISES EXCEPT AS EXPRESSLY STATED HEREIN NO AGREEMENT VARYING OR EXTENDING THIS LIMITED WARRANTY SHALL BE BINDING UPON INOVA LABS UNLESS IN WRITING SIGNED BY A DULY AUTHORIZED REPRESENTATIVE OF INOVA LABS THIS LIMITED WARRANTY IS EXCLUSIVE AND GIVEN AND ACCEPTED IN LIEU OF ANY AND ALL OTHER WARRANTIES AND TO THE FULLEST EXTENT PERMITTED UNDER APPLICABLE LAW INOVA LABS EXPRESSLY DISCLAIMS ANY AND ALL OTHER WARRANTIES EXPRESS OR IMPLIED INCLUDING WITHOUT LIMITATION THE IMPLIED WARRANTIES OF MERCHANTABILITY FITNESS FOR A PARTICULAR PURPOSE AND NON INFRINGEMENT Limitation of Liability TO THE FULLEST EXTENT PERMITTED UNDER APPLICABLE LAW IN NO EVENT SHALL INOVA LABS HAVE ANY LIABILITY FOR ANY CONSEQUENTIAL SPECIAL INCIDENTAL INDIRECT EXEMPLARY OR PUNITIVE DAMAGES INCLUDING WITHOUT LIMITATION LOST PROFITS LOS
33. s accessories Be sure to read all of the enclosed information in its entirety before using the LifeChoice Activox POC The POC is an internally powered Type BF device when powered by the Internal Battery and a Class II Type BF device when connected to the external AC Adapter Charger DC Adapter Charger or rechargeable External Battery The essential performance of the POC is to provide oxygen at a volume that remains within tolerance the tolerance was defined based on technical judgment from within the manufacturer s expertise in this specific medical application In addition the device s ability to detect certain error conditions such as low concentration or no breath and create an alarm is also considered a part of essential performance APPLICATION INDICATIONS FOR USE This manual applies to the LifeChoice Activox POC XYC100B SPT and XYC100B PRO INDICATIONS FOR USE The LifeChoice Activox Oxygen Concentrator is used on a prescriptive basis by patients who are diagnosed as requiring supplemental oxygen This oxygen concentrator will provide supplemental high concentration oxygen to these patients It is not life supporting nor life sustaining It may be used continuously in a home institution or travel environment The LifeChoice Activox is also portable This device should be used only when prescribed by a physician SYMBOL DESCRIPTIONS Symbol Description Symbol Description Symbol Description Consult Caution in
34. structions for No smoking use Do not Temperature Humidity Fragile handle Dae Compliant with with care f WEEE Manufacturer Date of Class II manufacture equipment This side up Type BF applied part Device that Catalogue has conductive number contact with patient CE Marking of Conformity Representative Rechargeable Portable Authorized battery Oxygen representative Concentrator in the European Connection Community l U S Federal law restricts this device to sale by or on the order of a physician 2 Itis the responsibility of the patient and or provider to make back up arrangements for an alternative oxygen supply 3 Availability of an alternate source of oxygen is required in case of power outage or mechanical failure 4 The device is designed to be used in the provided approved carry case The device should be located as to avoid pollutants or flames c 6 Portable and mobile RF communications equipment can affect medical electrical equipment The device should not be used adjacent to or stacked with other equipment a When traveling by air the device and External Battery must be transported as carry on not checked baggage 9 The device and external battery pack contain lithium ion batteries that are subject to special shipping regulations If shipping either the device or battery pack notify the shipper that the shipment will contain lithium ion batteries 10 In the event of a external battery s
35. ters and cables sold by the manufacturer of the medical electrical equipment as replacement parts for internal components may result in increased emissions or decreased immunity of the Model XYC100B XYC 100B SPT XYC 100B PRO t Nasal cannula may not be included Based on local international requirements 21 a2 WARRANTY LIMITED WARRANTY AND DISCLAIMER Limited Warranty NOTE This Limited Warranty provides specific legal rights The Purchaser may also have other rights which vary from state to state or country to country and in some cases due to applicable laws certain limitations or exclusions of this Limited Warranty may not apply Inova Labs Inc Inova Labs warrants solely to the first purchaser from Inova Labs or its authorized distributor Purchaser that each new portable unit or any combination thereof excluding the Sieve Bed Accessories and Batteries such new units excluding the Sieve Bed Accessories and Batteries hereinafter referred to as Product shall be free from defects of design materials and workmanship under normal use operation and service for three 3 years from the date of purchase meaning the date of purchase as evidenced by the sales receipt from Inova Labs or its authorized distributor hereafter referred to as the Date of Purchase The Sieve Bed is warranted to Purchaser be free of defects of design materials and workmanship under normal use operation and serv
36. to reach a 100 percent charge level when plugged into the unit and an AC or DC Adapter Charger Press the Battery Check button to check the charging progress NOTE By design the External Battery will power the POC when plugged in Once the External Battery depletes the unit will switch to internal battery power If both the Internal and External batteries are fully discharged it can take up to 7 5 hours to achieve a 100 percent charge level in both batteries ll OPERATING INSTRUCTIONS continued 4 When the External Battery is fully charged the EXT Battery Check LED will turn off NOTE The charge indicator will show 4 solid green lights when the battery has a charge level of 96 percent or more When the battery reaches a full 100 percent charge the EXT LED will turn off In the event the power supply is interrupted to the POC when the AC or DC Adapter Charger is connected a two second audible alarm will sound and the compressors will transition from external to internal power During this transition you may hear the compressors momentarily pause No action is required as the system will automatically transition to internal power and resume operation NOTE If the POC is powered off and either the AC or DC Adapter Charger is connected and charging is complete the internal fans may continue to operate for an additional period of time until the temperature inside the unit is sufficiently cooled REPRESSURIZATION If the unit
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