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oxycure Zen-O lite User Manual & Safety Instructions

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D.SPEC.26.4 Zen-O lite - Mode d'emploi_EN
Oxycure Concentrator
Zen-O lite
User manual
v. 28/06/2019

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  • Page 1 D.SPEC.26.4 Zen-O lite - Mode d'emploi_EN Oxycure Concentrator Zen-O lite User manual v. 28/06/2019...
  • Page 2 D.SPEC.26.4 Zen-O lite - Mode d'emploi_EN Thank you for choosing an Oxycure concentrator. The Oxycure range, from left to right Oxycure portable concentrators Oxycure portable concentrator – Inogen G4 Oxycure portable concentrator – Inogen G3 Oxycure portable concentrator – Zen-O lite Oxycure portable concentrator –...
  • Page 3 D.SPEC.26.4 Zen-O lite - Mode d'emploi_EN OXYCURE : ORDERS 081 22 15 90 Oxycure Belgium plc. Business Park Fernelmont L. Génicot, 9 B-5380 Fernelmont Belgium Tel + 32 (0)81 22 15 90 Fax + 32 (0)81 22 15 99 http://www.oxycure.be e-mail : oxycure@oxycure.be...
  • Page 4 D.SPEC.26.4 Zen-O lite - Mode d'emploi_EN Portable Oxygen Concentrator Model: RS - 00600 User Manual v. 28/06/2019...
  • Page 5 D.SPEC.26.4 Zen-O lite - Mode d'emploi_EN v. 28/06/2019...

  • Page 6: Table Of Contents

    D.SPEC.26.4 Zen-O lite - Mode d'emploi_EN English User manual: Zen-O lite™ Portable Oxygen Concentrator (Model: RS-00600) CONTENT 1. Foreword ................4 1.1.
  • Page 7 D.SPEC.26.4 Zen-O lite - Mode d'emploi_EN 8. Traveling with the Zen-O lite™ POC by Air ..........17 8.1.

  • Page 8: Foreword

    D.SPEC.26.4 Zen-O lite - Mode d'emploi_EN Foreword Please refer to this manual for detailed instructions on warnings, cautions, specifications, and ad- ditional information. Important: Users should read this entire manual before operating the Zen-O lite™ Portable Oxy- gen Concentrator. Failure to do so could result in personal injury and/or death. If you have ques- tions about the information in this user manual or about the safe operation of this system, contact your distributor.

  • Page 9: Typographical Conventions

    D.SPEC.26.4 Zen-O lite - Mode d'emploi_EN • ISO 7637-2:2011 Road Vehicles - Electrical disturbances from conduction and coupling- Part 2: Electrical transient conduction along supply lines only. • Medical Device Directive 93/42/EEC. This equipment is classified as: • Class II •...

  • Page 10: Safety Instructions

    D.SPEC.26.4 Zen-O lite - Mode d'emploi_EN Safety Instructions Warnings Overview 3.1. 1. The device must be used in the carry bag to provide protection from liquid intrusion from rain and/or spills. 2. There is a risk of fire associated with oxygen equipment and therapy. Do not use near sparks or open flames.

  • Page 11: Cautions Overview

    D.SPEC.26.4 Zen-O lite - Mode d'emploi_EN 15. Do not use lubricants on this device or any of its accessories. 16. Use of this device at an altitude above 4,000 m (13,000 feet), or outside the tempera- ture range of 5°C (41°F) to 40°C (104°F), or outside the humidity range of 5% to 93% may adversely affect the flowrate and percentage of oxygen and consequently the quality of therapy.
  • Page 12 D.SPEC.26.4 Zen-O lite - Mode d'emploi_EN 6. Patients with a fast breathing rate requiring a higher oxygen setting may require more oxygen than this device can produce - see Chapter 15 - Technical Description. This device may not be appropriate in that case. Consult your clinician for alternative treatment.

  • Page 13: Overview Of Important Information

    D.SPEC.26.4 Zen-O lite - Mode d'emploi_EN 23. Always disconnect power and turn off this device before cleaning, see Chapter 11 - Main- tenance and Cleaning 24. Do not obstruct air intake or exhaust vents when operating this device. Blockage can cause buildup of internal heat and shut down or damage this device.

  • Page 14: Product Description

    D.SPEC.26.4 Zen-O lite - Mode d'emploi_EN Product Description 5.1. Schematic Description Breath detect LED Alarm mute indicator Red LED - warning Display screen Green LED - power ON Yellow LED - warning Pulse setting Power button selection buttons Battery indicator...

  • Page 15: General Instructions Before Use

    D.SPEC.26.4 Zen-O lite - Mode d'emploi_EN General Instructions Before Use A variety of accessories can enhance the portability and use of the Zen-O lite™ Portable Oxy- gen Concentrator. In addition to the device, the package contains accessories to get started and a user manual. Contact your home oxygen provider for a complete list of available acces- sories.
  • Page 16 D.SPEC.26.4 Zen-O lite - Mode d'emploi_EN 6.2.1. Charging the Battery CAUTION: Only charge the battery in this device or in an approved charger section 6.1 - 6.1. Accessories List.). • Prior to using the device for the first time, install the battery as shown in Fig.

  • Page 17: Nasal Cannula

    D.SPEC.26.4 Zen-O lite - Mode d'emploi_EN IMPORTANT: Battery damage may result if the concentrator’s battery is allowed to discharge com- pletely. IMPORTANT: After 300 charge/discharge cycles, the battery capacity will be at least 80% of its original capacity. Replace the battery when the reduced battery life is affecting your mobility.

  • Page 18: Operating Zen-O

    D.SPEC.26.4 Zen-O lite - Mode d'emploi_EN Operating Zen-O lite™ IMPORTANT: Read Chapter 3. Safety Instructions before using this device. Zen-O lite™ Portable Oxygen Concentrator is designed for ease of use, with all functions ac- cessed through just a few buttons on the control panel.

  • Page 19: Turning On

    D.SPEC.26.4 Zen-O lite - Mode d'emploi_EN 7.2. Turning On • To turn the device on, press the power button • The concentrator will chirp and the green, yellow, and red LEDs will flash once, while the screen displays the device name.

  • Page 20: Battery Button

    D.SPEC.26.4 Zen-O lite - Mode d'emploi_EN 7.5. Battery Button The battery button allows you to check the status of the battery. Repeatedly pushing the button will cycle through all the information. • First, the gauge information will be shown • Next...

  • Page 21: Traveling With The Zen-O Lite™ Poc By Air

    D.SPEC.26.4 Zen-O lite - Mode d'emploi_EN Traveling with the Zen-O lite™ POC by Air 8.1. Passenger Pre-flight Preparation 8.1.1. Required Labeling Your Zen-O lite™ POC is suitable for aircraft use and has met all acceptance criteria of the Unit- ed States Federal Aviation Administration (FAA). This is verified by the statement on the back of the POC that states, in red text, “The manufacturer of this POC has determined this device...
  • Page 22 D.SPEC.26.4 Zen-O lite - Mode d'emploi_EN • Zen-O lite™ owner’s manual information regarding expected duration of battery power. IMPORTANT: You should never rely upon available onboard aircraft electrical power during a flight. • Air carrier requirements to carry a certain amount of batteries are typically available on each airline’s web site.

  • Page 23: Boarding And In-Flight Information

    D.SPEC.26.4 Zen-O lite - Mode d'emploi_EN 8.2. Boarding and In-flight Information 8.2.1. Carry-on baggage Your Zen-O lite™ POC is an assistive device. In this case, carriers shall not, in implementing their carry-on baggage policy, count the Zen-O lite™ POC toward a limit on carry-on items brought into the cabin by a qualified individual with a disability.

  • Page 24: Transportation Security Administration (Tsa) Requirements

    D.SPEC.26.4 Zen-O lite - Mode d'emploi_EN FAA safety rules. For example: 1. Some seats on an aircraft, such as bulkhead seats, may or may not have approved stow- age space to accommodate a Zen-O lite™ POC during movement on the surface, take-off, and landing.

  • Page 25: Alarm Indicators

    D.SPEC.26.4 Zen-O lite - Mode d'emploi_EN The following general security screening considerations apply to Zen-O lite™ POCs: 1. The limit of one carry-on and one personal item (e.g., purse, briefcase, or computer case) does not apply to medical supplies, equipment, mobility aids, and/or assistive devices carried by and/or used by a person with a disability.

  • Page 26: Alarms

    D.SPEC.26.4 Zen-O lite - Mode d'emploi_EN IMPORTANT: The most recent alarms indicated by the device are logged for reference by service personnel. This log is maintained even if the device is powered down or if power is lost for any other reason.
  • Page 27 D.SPEC.26.4 Zen-O lite - Mode d'emploi_EN 9.1.2. High Priority Alarms IMPORTANT: These alarms will allow the device to continue operating. Alarm message Description Action Device is unable to maintain oxy- Be sure air inlet/outlet has not been gen purity. blocked. If alarm persists, contact your distributor.
  • Page 28 D.SPEC.26.4 Zen-O lite - Mode d'emploi_EN 9.1.5. Other Messages Message Description Action External power has been discon- No action is required. nected; unit is now running on battery. Displayed while unit goes through No action is required. its power-down sequence.

  • Page 29: Troubleshooting

    D.SPEC.26.4 Zen-O lite - Mode d'emploi_EN Troubleshooting 10 . Problem Possible Cause Troubleshooting System becomes • System may be dis- • Check that the system is connected inoperative connected from the securely to the power source. • Ensure the system is powered on.

  • Page 30: Maintenance And Cleaning

    D.SPEC.26.4 Zen-O lite - Mode d'emploi_EN Maintenance and Cleaning 11 . 11.1. Routine Maintenance WARNING: Do not use lubricants on this device or any of its accessories. CAUTION: Replace the cannula on a regular basis. Check with your distributor or clinician to determine how often the cannula should be replaced.

  • Page 31: Device Repair And Disposal

    D.SPEC.26.4 Zen-O lite - Mode d'emploi_EN Device Repair and Disposal 12 . 12.1. Repair Do not attempt to repair the device. Contact your home oxygen provider or distributor for assistance (see Chapter 10 - Troubleshooting). The sieve modules may be replaced by the patient as determined by the home oxygen pro- vider or distributor.

  • Page 32: Disposal

    Test Failed - Press battery button to exit, then repeat steps 4-15. 16. If the leak test has passed, then clear the device sieve hour counter. a. Turn on your Zen-O lite portable oxygen concentrator. b. Simultaneously press the buttons until "Diagnostics" is displayed.

  • Page 33: Technical Description

    D.SPEC.26.4 Zen-O lite - Mode d'emploi_EN 14.2.1. This Document The information in this document is subject to change without notice. This document con- tains proprietary information that is protected by copyright. No part of this document may be reproduced in any manner, in whole or in part (except for brief excerpts in reviews and scien- tific papers), without the prior written consent of the manufacturer.
  • Page 34 D.SPEC.26.4 Zen-O lite - Mode d'emploi_EN Technical Description (continued) Type of protection (electrical): Class II Degree of protection (electrical): Type BF Degree of protection IP22 in carry bag (protection against small objects and tilted drip- (water): ping water) IP20 out of carry bag (protection against small objects and no...

  • Page 35: Electromagnetic Compatibility (Emc) Information

    D.SPEC.26.4 Zen-O lite - Mode d'emploi_EN 15.1. Electromagnetic Compatibility (EMC) Information Medical electrical equipment requires special cautions regarding electromagnetic compati- bility (EMC). Portable and mobile radio frequency (RF) communications equipment can affect devices such as the Zen-O lite™ Portable Oxygen Concentrator. As such, the device should not be used adjacent to other equipment.
  • Page 36 D.SPEC.26.4 Zen-O lite - Mode d'emploi_EN 15.1.2. Guidance and Manufacturer’s Declaration: Electromagnetic Immunity Zen-O lite™ is intended for use in the electromagnetic environment specified below. The cus- tomer or the user of the concentrator should assure that it is used in such an environment.
  • Page 37 D.SPEC.26.4 Zen-O lite - Mode d'emploi_EN Immunity test IEC 60601 test Compliance Electromagnetic environment/ level level guidance Conducted RF 3 Vrms 150 kHz 3 Vrms Portable and mobile RF communi- IEC 61000-4-6 to 80 Mhz ; (6Vrms ISM cations equipment should be used...

  • Page 38: Glossary - Explanation Of Packaging And Labelling Symbols

    D.SPEC.26.4 Zen-O lite - Mode d'emploi_EN 15.1.3. Recommended Separation Distances between Portable and Mobile RF Communications Equipment and the Zen-O lite™ Portable Oxygen Concentrator The Zen-O lite™ Portable Oxygen Concentrator is intended for use in an electromagnetic en- vironment in which radiated RF disturbances are controlled. The concentrator user can help...
  • Page 39 D.SPEC.26.4 Zen-O lite - Mode d'emploi_EN Glossary - Explanation of Packaging and Labelling Symbols U.S. federal law restricts this device to sale by or on the Date of manufacture order of a physician Do not use if packaging is Manufacturer...

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