NOW MORE W I T H BA LESS W TTERY, EIGHT ! Operator’s Manual For Use with models: XYC100B-SPT & XYC100B-PRO Manufactured & Distributed by www.InovaLabs.
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 www.InovaLabs.
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
INTRODUCTION The Operator’s Manual will provide familiarity with all models of the LifeChoice Activox Portable Oxygen Concentrator (POC) and its 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.
Symbol Descriptions Symbol Description Symbol Description Symbol Description Caution Consult instructions for use No smoking No open flame No oil or grease Do not disassemble Temperature limit Humidity limitation Keep dry This side up Fragile, handle with care Compliant with WEEE Manufacturer Date of manufacture Class II equipment Type BF applied part Device that has conductive contact with patient Catalogue number CE Marking of Conformity Representative Gas flow Prescription only
Contraindications 1. The device is not intended to be life-sustaining or life-supporting. 2. In certain circumstances, oxygen therapy can be hazardous. Please seek medical advice before using this device. 3. 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. 4.
Standard Package Contents 8 2 1 7 5 4 6 1 LifeChoice Activox POC 4-Way Carry Case 2 Use as a backpack, shoulder 3 5 AC Power Adapter 6 DC Power Adapter strap, waist pack or briefcase Adjustable Straps Standard 7-Foot (2-meter) Long 3 For use with 4-Way Carry Case 7 Single Lumen Nasal Cannula† 4 External Battery* 8 Accessory Bag Model identified on unit and packaging labels. See . *An optional External Battery is available for purchase which provides up to 3 hours of additional battery time.
User Controls Control Panel Pulse Setting Control Buttons 1, 2, 3 LPMeq Alarm Indicator Power Button Auto Mode Indicators Battery Charge Indicator Mute Button INT & EXT Indicators Battery Check Button Hour Meter Button For use by trained service personnel only Indicator Lights: Colored LED lights indicate either a change in operating status or a condition that may need response (alarm).
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 75% LED 100% LED Off Off Off Off 0%* Blinking Off Off Off 1% -12%* On Off Off Off 13% - 25% On Blinking Off Off 26% - 37% On On Off Off 38% - 50% On On Blinking Off 51% - 62% On On On Off 63% - 75% On On On Blinking 76% - 95% On On On On 96% - 100% NOTE: Charge level indication is approximate.
PART NAMES Cannula Nozzle Fitting Control Panel Fan Inlet Vent Fan Outlet 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.
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 reference the Carry Case Configuration Instructions. Follow these steps before first use: 1. 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.
OPERATING INSTRUCTIONS continued 2. AC Adapter/Charger: An AC Adapter/Charger allows the POC to be powered from a 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.
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 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.
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.
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.
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. 3. Press the Power Button once to turn the unit on.
5. 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 oxygen is delivered. 6. Place the nasal cannula in the nasal passages and breathe normally.
LIGHT INDICATORS/ALARMS NORMAL OPERATION INDICATORS Normal Operation Audible Alert POC turned on Brief audible tone Light Indication Green LEDs of Power, Active-High and Pulse Setting 1 are illuminated.
Alarm Indicators Problem No breath detected by the unit for approximately 75 seconds Audible Alert Light Indication Action Amber Alarm LED light flashes Check cannula connection. Breathe through nose and alarm will shut off. If alarm persists, contact your provider.
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.
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 it is has not been used on a daily basis.
OXYGEN CONCENTRATION OVER ALTITUDE AND FLOW RATE Oxygen Concentration Over Altitude Range 0-4000 m 95% Oxygen 90% 85% 80% 1 LPMeq 2 LPMeq Flow Rate 3 LPMeq 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” h x 4.38” d (22.98 cm w x 20.00 cm h x 11.
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. (3 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.
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.
WARRANTY continued 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.
WARRANTY 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.
WARRANTY continued FORM OF THE CLAIM, WHETHER IN 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.
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 XYC100BSPT/XYC100B-PRO is intended for use in the electromagnetic environment specified below.
Guidance and Manufacturer’s Declaration - Electromagnetic Immunity The LifeChoice® Activox Portable Oxygen Concentrator Model XYC100BSPT/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.
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 XYC100BSPT/XYC100B-PRO is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
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NOW MORE W I T H BA LESS W TTERY, EIGHT ! Manufactured & Distributed by 3500 Comsouth Drive, Suite 100, Austin, Texas 78744 USA Corporate Office 1.512.617.1700 | www.InovaLabs.com © 2014 Inova Labs Inc. All rights reserved. Made in the USA.