oxycure Zen-O lite Manual del operador
Oxycure Concentrator
Zen-O lite
User manual
D.SPEC.26.4 Zen-O lite - Mode d'emploi_EN
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Thank you for choosing an Oxycure concentrator.
More information at www.oxycure.be
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 – Simply Go Mini
Oxycure portable concentrator – SimplyGo
Oxycure portable concentrator – eQuinox
Oxycure concentrators
Oxycure – Kröber concentrator
Oxycure cylinders (gaseous oxygen)
Oxycure B2 cylinder – 0.4 m³
Oxycure B5 cylinder – 1.0 m³
Oxycure tanks (liquid oxygen)
Oxycure liquid oxygen tank – 25.6 m³
Oxycure portable liquid oxygen tank (1.0 m³)
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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
OPENING HOURS
From Monday to Friday 09.00 – 12.30 and 13.30 – 18.00
CUSTOMER SERVICE 0800 98 0 68
Our customer service operates 24/7.
It is exclusively to urgent installations or repairs on our medical devices.
Call to guard service
Leave a message on the answering machine with your name and phone number and give a brief reason of
your call ;
The customer service will call you within 20 minutes ;
If the customer service did not call you within 20 minutes, call again.
Notes
1. Technical interventions (repairs) are included in the price of the assistance of the leasing.
2. Deliveries of goods, outside the opening hours, will be charged.
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User Manual
Portable Oxygen Concentrator
Model: RS - 00600
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User manual: Zen-O lite™ Portable Oxygen Concentrator (Model: RS-00600)
CONTENT
1. Foreword ..............................................................................4
1.1. General Information .................................................................4
1.2. Classication........................................................................4
1.3. Typographical Conventions ..........................................................5
2. Intended Use...........................................................................5
3. Safety Instructions .....................................................................6
3.1. Warnings Overview..................................................................6
3.2. Cautions Overview ..................................................................7
3.3. Overview of Important Information:..................................................9
4. Instructions and Training ...............................................................9
5. Product Description ....................................................................10
5.1. Schematic Description...............................................................10
6. General Instructions Before Use .........................................................11
6.1. Accessories List......................................................................11
6.2. Battery .............................................................................11
6.3. Nasal Cannula.......................................................................13
7. Operating Zen-Olite™ ..................................................................14
7.1. Connecting a Nasal Cannula .........................................................14
7.2. Turning On..........................................................................15
7.3. Choosing a Preferred Language ......................................................15
7.4. Adjusting Setting ...................................................................15
7.5. Battery Button ......................................................................16
7.6. Responding to Alarms ...............................................................16
7.7. Turning O..........................................................................16
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User manual: Zen-O lite™ Portable Oxygen Concentrator (Model: RS-00600)
8. Traveling with the Zen-Olite™ POC by Air ...............................................17
8.1. Passenger Pre-ight Preparation .....................................................17
8.2. Boarding and In-ight Information ...................................................19
8.3. Transportation Security Administration (TSA) Requirements...........................20
9. Alarm Indicators. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .21
9.1. Alarms..............................................................................22
10. Troubleshooting ......................................................................25
11. Maintenance and Cleaning ............................................................26
11.1. Routine Maintenance...............................................................26
11.2. Cleaning...........................................................................26
11.3. Service Life ........................................................................26
11.4. Service Connector..................................................................26
12. Device Repair and Disposal ............................................................27
12.1. Repair .............................................................................27
12.2. Sieve Modules Replacement Instructions: ...........................................27
12.3. Disposal ...........................................................................28
13. Warranty .............................................................................28
14. Trademarks and Disclaimer ............................................................28
14.1. Trademark .........................................................................28
14.2. Disclaimer .........................................................................28
15. Technical Description..................................................................29
15.1. Electromagnetic Compatibility (EMC) Information ...................................31
16. Glossary - Explanation of Packaging and Labelling Symbols .............................34
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Foreword
Please refer to this manual for detailed instructions on warnings, cautions, specications, and ad-
ditional information.
Important: Users should read this entire manual before operating the Zen-Olite™ 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.
1.1. General Information
This user manual provides information for users of the Zen-Olite™ Portable Oxygen Concen-
trator. For the sake of brevity, the terms“concentrator,”"POC",“unit,” or“device”are sometimes
used in this document to refer to the Zen-Olite™ Portable Oxygen Concentrator. "Patient"
and "User" are used interchangeably.
1.2. Classication
This device is listed with an internationally recognised testing laboratory and classied with
respect to electric shock, re, and mechanical hazards in accordance with the following stand-
ards:
• IEC/EN 60601-1:2012, Medical Electrical Equipment – Part 1: General Requirements for Basic
Safety and Essential Performance.
• IEC/EN 60601-1-2:2014, Part 1-2: General Requirements for Safety – Collateral Standard:
Electromagnetic Compatibility – Requirements and Tests.
• IEC/EN 60601-1-6:2010+A1:2013 Medical Electrical Equipment – Part 1-6: General
Requirements for Basic Safety and Essential Performance – Collateral Standard: Usability.
• IEC/60601-1-8:2006 Medical Electrical Equipment – Part 1-8: General Requirements for
Safety – Collateral Standard: General Requirements, Tests and Guidance for Alarm Systems
in Medical Electrical Equipment and Medical Electrical Systems.
• IEC/60601-1-11:2011 Medical Electrical Equipment - Part 1-11: General Requirements for
Safety - Collateral Standard: Requirements for Medical Electrical Equipment and Medical
Electrical Systems Used in the Home Healthcare Environment.
• ISO 80601-2-67:2014, Medical Electrical Equipment - Part 2-67: Particular Requirements for
Basic Safety and Essential Performance of Oxygen Conserving Equipment.
• ISO 80601-2-69:2014, Medical Electrical Equipment - Part 2-69: Particular Requirements for
Basic Safety and Essential Performance of Oxygen Concentrator Equipment.
• CAN/CSA C22.2 No. 60601-1:14, Canadian Standard, Medical Electrical Equipment - Part 1:
General Requirements for Basic Safety and Essential Performance.
• RTCA DO-160G:12/8/2010 Environmental Conditions and Test Procedures for Airborne
Equipment.
1.
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• 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 classied as:
• Class II
• Class IIa according to the MDD 93/42/EEC
• Type BF
• IP22 with the carry bag
1.3. Typographical Conventions
This user manual contains warnings, cautions, and notes to help call attention to the most im-
portant safety and operational aspects of the device. To help identify these items when they
occur in the text, they are shown using the following typographical conventions:
WARNING: Statements that describe serious adverse reactions and potential safety haz-
ards.
CAUTION: Statements that call attention to information regarding any special care to be ex-
ercised by the practitioner and/ or patient for the safe and eective use of the device.
IMPORTANT: Statements calling attention to additional signicant information about the device
or a procedure.
Intended Use
Zen-Olite™ portable oxygen concentrator is intended to provide supplemental oxygen to
patients with chronic pulmonary diseases and any patient requiring supplemental oxygen.
The device is portable, enabling patients who need an oxygen device to be treated at home
according to a clinician’s prescription or direction.
Zen-Olite™ is not intended for use in life supporting or life sustaining situations, and is pro-
vided non-sterile. It is a prescription only device, and designed for indoor and outdoor use.
For correct operational conditions see Chapter 15. Technical Description.
Zen-Olite™ Portable Oxygen Concentrator is not intended to be used:
• in life-supporting or life-sustaining situations
• in an operating or surgical environment
• with a non-adult population
• in conjunction with ammable anaesthetic or ammable materials
2.
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Safety Instructions
3.1. Warnings Overview
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 re associated with oxygen equipment and therapy. Do not use near
sparks or open ames.
3. The settings of Zen-Olite™ Portable Oxygen Concentrator RS-00600 might not corre-
spond with continuous ow oxygen.
4. The settings of other models or brands of portable oxygen concentrators do not cor-
respond with the settings of Zen-Olite™ Portable Oxygen Concentrator RS-00600.
5. Wind or strong drafts can adversely aect accurate delivery of oxygen therapy.
6. Geriatrics or any other patient unable to communicate discomfort can require addi-
tional monitoring to avoid harm.
7. Smoking (including e-cigarettes) during oxygen therapy is dangerous and is likely to
result in facial burns, serious injury or death of the patient and others from re. Do
not allow smoking or open ames within the same room as the portable oxygen con-
centrator or any oxygen carrying accessories. If you smoke, you must always turn the
oxygen concentrator o, remove the cannula and leave the room where either the
cannula or the concentrator is located. If unable to leave the room, you must wait 10
minutes after the ow of oxygen has been stopped.
8. Use only water based lotions that are oxygen compatible, before and during oxygen
therapy. Never use petroleum or oil based lotions or salves when operating the device
to avoid the risk of re and burns.
9. Open ames during oxygen therapy are dangerous and are likely to result in re or
death. Do not allow open ames within 3 metres (10 feet) of the oxygen concentrator
or any oxygen carrying accessory.
10. Oxygen makes it easier for a re to start and spread. Do not leave the nasal cannula
on bed coverings or chair cushions with the concentrator on, but not in use; the oxy-
gen will make the materials ammable. Turn the concentrator o when not in use to
prevent oxygen enrichment.
11. Explosion hazard. Do not use in the presence of ammable anaesthetics!
12. Do not use this device in the presence of pollutants or fumes.
13. Do not submerge this device in liquid. Do not expose to water or precipitation. Do not
expose to dusty conditions.
14. Do not use a device or any accessory that shows any sign of damage.
3.
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