GCE Zen-O lite Návod na používanie

GCE HEALTHCARE

User Manual

Portable Oxygen Concentrator

Models: RS-00600 & RS-00600C

English . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

Magyar . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44

Türkçe . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 88

Česky . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 130

172 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .ﺔﻴﺑﺮﻌﻟا ﺔﻐﻠﻟا

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User manual: Zen-O lite™ Portable Oxygen Concentrator

(Model: RS-00600/RS-00600C)

CONTENT

1. Foreword . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4

1.1. General Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4

1.2. Classiﬁ cation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4

1.3. Typographical Conventions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5

2. Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5

3. Safety Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6

3.1. Warnings Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6

3.2. Cautions Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8

3.3. Important Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10

4. Instructions and Training . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10

5. Product Description. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11

5.1. Schematic Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11

6. General Instructions Before Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12

6.1. Accessories List . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12

6.2. Battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12

6.3. Nasal Cannula . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14

7. Operating Zen-Olite™ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .15

7.1. Connecting a Nasal Cannula . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .15

7.2. Turning On . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .16

7.3. Choosing a Preferred Language . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .16

7.4. Adjusting Setting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .16

7.5. ECO Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .17

7.6. Battery Button . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .17

7.7. Responding to Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .17

7.8. Turning O . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .18

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User manual: Zen-O lite™ Portable Oxygen Concentrator

(Model: RS-00600/RS-00600C) 8. Traveling with the Zen-Olite™ POC by Air . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .18

8.1. Passenger Pre-ﬂ ight Preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .18

8.2. Boarding and In-ﬂ ight Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .20

8.3. Transportation Security Administration (TSA) Requirements . . . . . . . . . . . . . . . . . . . . . .22

8.4. Placing your device in Airplane Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .22

9. Alarm Indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .23

9.1. Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .24

10. Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .27

11. Maintenance and Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .28

11.1. Routine Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .28

11.2. Cleaning and Disinfection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .28

11.3. Service Life . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .28

11.4. Service Connector . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .29

12. Device Repair and Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .29

12.1. Repair . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .29

12.2. Sieve Modules Replacement Instructions: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .29

12.3. Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .30

13. Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .31

14. Trademarks and Disclaimer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .33

14.1. Trademark . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .33

14.2. Disclaimer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .33

15. Technical Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .33

15.1. Electromagnetic Compatibility (EMC) Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .36

15.2. FCC warning statement for Model RS-00600C: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .40

15.3. EU RED Article 10(10) Restrictions on Use for Model RS-00600C: . . . . . . . . . . . . . . . . .40

15.4. RF Exposure Information: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .42

16. Glossary - Explanation of Packaging and Labelling Symbols . . . . . . . . . . . . . . . . . . . . . . . .42

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1. FOREWORD

Please refer to this manual for detailed instructions on warnings, cautions, speciﬁ ca-

tions, and additional information.

Important: Users should read this entire manual before operating the Zen-Olite™ Port-

able Oxygen Concentrator. Failure to do so could result in personal injury and/or death.

If you have questions about the information in this user manual or about the safe opera-

tion of this system, contact your distributor.

1.1. GENERAL INFORMATION

This user manual provides information for users of the Zen-Olite™ Portable Oxygen Con-

centrator. For the sake of brevity, the terms “concentrator,” "POC", “unit,” or “device” are

sometimes used in this document to refer to the Zen-Olite™ Portable Oxygen Concentra-

tor. "Patient" and "User" are used interchangeably.

1.2. CLASSIFICATION

This device is listed with an internationally recognised testing laboratory and classiﬁ ed

with respect to electric shock, ﬁ re, and mechanical hazards in accordance with the fol-

lowing standards:

• 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.

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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 classiﬁ ed as:

• Class II FDA classiﬁ cation

• Class IIa according to the MDD 93/42/EEC

• Type BF in accordance with IEC 60601

• IP22 in accordance with IEC 60509

1.3. TYPOGRAPHICAL CONVENTIONS

This user manual contains warnings, cautions, and notes to help call attention to the most

important 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

hazards.

CAUTION: Statements that call attention to information regarding any special care to be

exercised by the practitioner and/ or patient for the safe and eﬀ ective use of the device.

IMPORTANT: Statements calling attention to additional signiﬁ cant information about the

device or a procedure.

2. INTENDED USE

Zen-Olite™ portable oxygen concentrator is intended to provide supplemental oxygen

to patients with chronic pulmonary diseases and any patient requiring supplemental oxy-

gen.

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-Olite™ is not intended for use in life supporting or life sustaining situations, and is

provided 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-Olite™ 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 ﬂ ammable anaesthetic or ﬂ ammable materials

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3. 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 ﬁ re associated with oxygen equipment and therapy. Do not use

near sparks or open ﬂ ames.

3. The settings of Zen-O lite™ Portable Oxygen Concentrator RS-00600/RS-00600C

might not correspond with continuous ﬂ ow oxygen.

4. The settings of other models or brands of portable oxygen concentrators do not cor-

respond with the settings of Zen-Olite™ Portable Oxygen Concentrator RS-00600/

RS-00600C.

5. Wind or strong drafts can adversely aﬀ ect 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 ﬁ re. Do

not allow smoking or open ﬂ 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 oﬀ , 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 ﬂ 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 de-

vice to avoid the risk of ﬁ re and burns.

9. Open ﬂ ames during oxygen therapy are dangerous and are likely to result in ﬁ re or

death. Do not allow open ﬂ ames within 3 metres (10 feet) of the oxygen concentrator

or any oxygen carrying accessory.

10. Oxygen makes it easier for a ﬁ 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 ﬂ ammable. Turn the concentrator oﬀ when not in use to

prevent oxygen enrichment.

11. Explosion hazard. Do not use in the presence of ﬂ 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.

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14. Do not use a device or any accessory that shows any sign of damage.

15. Do not use lubricants on this device or any of its accessories to avoid the risk of ﬁ re

and burns.

16. Use of this device at an altitude above 4,000 m (13,000 feet), or outside the tem-

perature range of 5°C (41°F) to 40°C (104°F), or outside the humidity range of 5% to

93% may adversely aﬀ ect the ﬂ owrate and percentage of oxygen and consequently

the quality of therapy. When not in use, the device should be stored in a clean, dry

environment between -20°C and 60°C (-4°F and 140°F). Use and/or storage outside of

the valid conditions may damage the product. For more technical details see Chapter

15. Technical Description. Allow this device up to 20 minutes to warm/cool from stor-

age temperatures to operating temperature before use.

17. Always ensure the battery is inserted before using this device.

18. If feeling ill or experiencing discomfort while using this device, contact your clinician

or seek medical assistance immediately to avoid harm.

19. Your home oxygen provider must verify the compatibility of the device and all acces-

sories used prior to use. To ensure you are receiving the therapeutic amount of oxy-

gen for your medical condition, the device and accessories must only be used after

one of more settings have been determined or prescribed for you at your speciﬁ c

activity levels by a healthcare professional.

20. The electrical cord and tubing could present a tripping or strangulation hazard. Keep

away from children and pets.

21. Do not disassemble or modify this device or any of its accessories. Do not attempt

any maintenance other than tasks described in Chapter 10 - Troubleshooting. Disas-

sembly can create an electric shock hazard and will void the warranty. Contact your

distributor for servicing by authorised personnel.

22. Use only spare parts recommended by the manufacturer to ensure proper function

and to avoid the risk of ﬁ re and burns.

23. Do not repair or perform service work while the device is in use by the patient.

24. Do not position your device and its power supply such that it is, di cult to unplug from

the power source in the event of an emergency or it is di cult to isolate the device in

the event of a ﬁ re, electrical hazard or any other incident.

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3.2. CAUTIONS OVERVIEW

1. Keep away from heat sources (ﬁ replaces, radiant heaters, etc.) that could cause the

operating temperature at or near the device to exceed 40°C (104°F).

2. The display may be diﬃ cult to read under bright lighting conditions (sunlight, interior

lights, etc.), move away from direct light for viewing the display.

3. Keep away from lint or other loose material that could block the air intake vents.

4. Some countries restrict this device to be sold by or on an order of a prescribing clini-

cian. Please ensure you comply with relevant local laws.

5. Non-prescribed oxygen therapy can be hazardous under certain circumstances. Use

this device only when prescribed by a clinician.

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.

7. Always operate the device at the setting prescribed by a clinician. Do not alter the

setting unless prescribed by a clinician. Periodic reassessment of the ﬂ ow settings

should be done by a clinician.

8. Do not use this device while sleeping unless prescribed by your clinician.

9. It is recommended for an alternate source of oxygen to be made available in the

event of power outage or mechanical failure. Consult your home oxygen provider or

clinician for an appropriate backup system.

10. This device may not reach speciﬁ ed oxygen concentration purity until it has been in

use for up to 2 minutes at set ﬂ owrate. Additional warm up time of up to 30 minutes

may be required to reach an optimum oxygen purity level, if the device has been

stored/unused for an extended period or kept in cold temperatures.

11. This device is designed for use by one patient at a time.

12. If you are unable to hear or see alarms, do not have normal tactile sensitivity, or can-

not communicate discomfort, consult a clinician before using this device.

13. If oxygen concentration drops below the speciﬁ ed level, an alarm will indicate this

condition. If alarm persists, stop using this device, switch to an alternate source of

oxygen, and contact your home oxygen provider.

14. Only use approved accessories with this device. See approved accessories list in

section 6.1 and cannula approved for use with this device. Using unapproved acces-

sories or cannula may impair the performance of this device.

15. This device is not designed for use with a humidiﬁ er or nebuliser. If a humidiﬁ er or

nebuliser is used with this device, performance may be diminished and the device

may be damaged.

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16. Always follow the cannula manufacturer’s instructions for proper use.

17. Replace the cannula on a regular basis. Check with your home oxygen provider or

clinician to determine how often the cannula should be replaced.

18. Check that this device operates on battery after disconnecting from the power source.

19. Only charge battery in this device or in an approved charger. (See approved acces-

sories list.)

20. Remove battery if this device is not going to be used for more than seven days. Store

battery in a cool, dry place.

21. Do not use cleaning agents other than those speciﬁ ed in this manual. Allow the clean-

ing solution to dry from the cleaned surface before use.

22. Always turn oﬀ this device when not in use.

23. Always disconnect power and turn oﬀ this device before cleaning, see Chapter 11 -

Maintenance 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.

25. Do not place objects on top of this device.

26. Keep away from children and pets to prevent damage to the device and accessories

and/or inadvertent setting changes.

27. Keep the device away from pets and pests.

28. This device is rated IP22 while used in the carry bag. Do not use in dusty or wet con-

ditions.

29. Always use in a well ventilated location.

30. Always follow the maintenance schedule as speciﬁ ed in section 11.1 - Routine Main-

tenance.

31. If this device indicates an abnormal condition, see Chapter 10 - Troubleshooting.

32. Use caution when touching this device in high ambient temperatures.

33. The device can be re-used by a new patient. The device should be cleaned as indi-

cated in section 11.2 of this user manual and, according to local laws and prescrip-

tions prior to delivering to a new patient.

34. The device can be isolated from power by disconnecting the power supply from the

input connector, see ﬁ g. 1, position the device for easy access to the power supply

input connector.

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3.3. IMPORTANT INFORMATION

1. If an extension cord is necessary, use a UL listed 15 amp or higher cord. Do not con-

nect any other devices on the same extension cord. Do not use a multisocketed

extension cord.

2. Inhale through the nose for the concentrator to work most e ectively. Inhaling

through the mouth may result in less e ective oxygen therapy.

3. Your device is designed for everyday use, for optimum performance use your device

for a minimum of 4 hours a day.

4. INSTRUCTIONS AND TRAINING

The Medical Devices Directive 93/42/EEC states that the product provider must ensure

that all users of the device are provided with the User Manual. The User Manual for this

device has been written to account for training and knowledge of the patient population

in order to operate the device appropriately.

WARNING: Do not use the product without ﬁ rst reading the user manual. Do not oper-

ate this device if unsure of its operation or function. Contact your home oxygen pro-

vider for assistance or further information.

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5. PRODUCT DESCRIPTION

5.1. SCHEMATIC DESCRIPTION

Green LED - power ON

Power button

Display screen

Battery indicator Alarm mute button

Alarm mute indicator

Red LED - warning

Yellow LED - warning

Pulse setting

selection buttons

Breath detect LED

Air intake

Battery cover

Battery

Fig. 1

Power

input

Exhaust

vent

Battery release

button

Nasal

cannula port

• The device uses a process called pressure swing adsorption to produce high concen-

tration of oxygen from the atmosphere, a nasal cannula is used to deliver the oxygen

to the patient.

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6. GENERAL INSTRUCTIONS BEFORE USE

A variety of accessories can enhance the portability and use of the Zen-Olite™ Portable

Oxygen 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 accessories.

Always inspect the device and its accessories for any sign of damage before use.

Important: While the box or packaging may exhibit some damage, e.g., tears or dents,

the device may still be in a usable condition. If the device or any accessory shows any

sign of damage, contact your home oxygen provider.

Before you get started, check to make sure you have the following:

• Concentrator

• Battery

• Carry bag

• Accessory bag

• AC power supply

• DC power supply

6.1. ACCESSORIES LIST

Only use power supplies/adapters or accessories speciﬁ ed in this manual. Using ac-

cessories that are not speciﬁ ed may create a hazard and/or negatively aﬀ ect the perfor-

mance of the device.

• Rechargeable battery (RS-00601)

• AC power supply – European cord

(RS-00602)

• AC power supply – United Kingdom

cord (RS-00603)

• AC power supply – North America cord

(RS-00604)

• AC power supply without cord

(RS-00612)

• DC power supply (RS-00605)

• Carry bag (RS-00606)

• European power cord (RS-00504)

• United Kingdom cord (RS- 00506)

• North America cord (RS-00503)

• External battery charger

- European (RS-00516)

• External battery charger

- North America (RS-00515)

• External battery charger

- United Kingdom (RS-00517)

• Nasal cannula MM6012

Note: Contact your provider or retailer if your speciﬁ c power supply connection is not

listed.

WARNING: Do not use the device or any accessory that shows any sign of damage.

6.2. BATTERY

Zen-Olite™ Portable Oxygen Concentrator can always be used when directly connected

to a power source. However, to enhance its portability, the concentrator is equipped with

a rechargeable lithium-ion internal battery.

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WARNING: Always ensure the battery is inserted

before using this device.

IMPORTANT: Optional power cords are available

for various global use and travel (see Section 6.1 -

6.1. Accessories List).

6.2.1. Charging the Battery

CAUTION: Only charge the battery in this device

or in an approved charger section 6.1 - 6.1. Acces-

sories List.).

• Prior to using the device for the ﬁ rst time, install

the battery as shown in Fig. 2. the battery will

latch when fully seated.

• Close the battery compartment ensuring the cov-

er latches to the device.

• Connect the AC/DC power supply by plugging

the round connector into the power input on the

side of the concentrator Fig. 3.

• Plug the other end of the AC/DC power supply

into a power outlet. Always use caution when in-

serting the power supply to a wall outlet.

• The display shows .

The charger is universal and supports a wide vari-

ety of international markets, so it can be plugged

into an outlet with 100-240V AC, 50-60 Hz.

Allow the battery/batteries to fully charge before

ﬁ rst time use. Once completely charged, the de-

vice can run for up to 4 hours on battery power, at

setting 2 and 18 breaths per minute.

IMPORTANT: Battery run time may vary based on

breathing rate, age of battery, and environmental conditions. See displayed text on de-

vice for battery charge status.

IMPORTANT: Ensure power status icon (see Fig. 7) indicates power is connected. If not,

check that cord is plugged in completely (see Chapter 10 - Trouble shooting for more

information)

Fig. 2

Fig. 3

Power

supply

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To maximise battery life and run time, avoid letting the battery deplete and use while

connected to a power source whenever possible. The battery will automatically charge

whenever the concentrator is connected to a power source. You can use the device

while the battery is charging. The LCD display will indicate whether the device is operat-

ing on battery or external AC power.

The fully charged battery will retain some level of charge for up to thirty days in this de-

vice when not in use - see Caution below for battery removal/storage recommendation.

IMPORTANT: Battery damage may result if the concentrator’s battery is allowed to dis-

charge completely.

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 a ect-

ing your mobility.

IMPORTANT: The DC power supply should be utilised on vehicles with the proper power

output rating.

IMPORTANT: The vehicle should be running while utilising the DC adapter to power the

Zen-Olite™ Portable Oxygen Concentrator.

CAUTION: Remove battery if this device is not going to be used for more than seven

days. Store battery in a cool, dry place.

CAUTION: Check that this device operates on battery after disconnecting from the pow-

er source.

IMPORTANT: When not using the battery inside the unit, be sure to store it in the protec-

tive sleeve that was provided with the original package. If the battery will not be utilised

for long durations, charge the battery fully at a minimum of once per year.

6.3. NASAL CANNULA

Only use a nasal cannula with the following speciﬁ cations:

• Length: 1.2m (4ft), 2.1m(7ft) or 7.6m(25ft)

• High ﬂ ow

• Crush resistant

• Large internal diameter bore

• Suitable for up to 15 litres per minute (lpm) at a max. pressure of 3.6 psi

• Meets substance compatibility of IEC/EN 60601-1

CAUTION: Only use approved accessories with this device. Refer to the approved ac-

cessories guide for a complete list of accessories and cannula approved for use with this

device. Using unapproved accessories or cannula may impair the performance of this

device, including ﬂ ow rate or oxygen purity.

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Contact your distributor for updated information and accessories or if additional, option-

al, or replacement accessories are needed.

7. 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

accessed through just a few buttons on the control panel.

The device should be carried in its carry bag and used when

positioned upright on a ﬂ at surface or on the ﬂ oor while in the

carry bag. The patient should be within the recommended

cannula length during use.

IMPORTANT: Except during startup and shutdown sequenc-

es, the backlight on the display screen will remain o . Press-

ing any button will turn the backlight on brieﬂ y. The backlight

will also remain activated during an un-muted alarm condi-

tion.

7.1. CONNECTING A NASAL CANNULA

CAUTION: Replace the cannula on a regular basis. Check

with your home oxygen provider or clinician to determine

how often the cannula should be replaced.

CAUTION: Always follow the cannula manufacturer’s instruc-

tions for proper use.

Connect the tubing to the cannula port as shown in Fig. 5.

To connect the cannula to the patient, position the cannula

tips in patient’s nostrils and pass tubing over both ears and

under chin. Follow manufacturer’s instructions.

Slide adapter up tubing to adjust for comfort and ﬁ t.

Once the cannula is secured, breathe normally through the

nose. Zen-Olite™ will detect a breath and deliver the oxygen

during inhalation.

IMPORTANT: Improper cannula placement may result in the

device being unable to detect all respiratory e orts of the

patient. Ensure cannula is connected securely and it has been fully inserted.

Cannula

port

Fig. 5

Fig. 6

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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 ﬂ ash once, while

the screen displays the device name.

Red LED - indicates a warning danger and/or a need for urgent action

Yellow LED - indicates caution or attention required

Flashing green LED - indicates oxygen is being delivered.

IMPORTANT: No adjustments can be made until the startup sequence is completed.

7.3. CHOOSING A PREFERRED LANGUAGE

• While the device is on, hold down the plus and mute buttons together for ap-

proximately four seconds until it says “Language:”.

• Next cycle through the available languages using the plus or minus buttons.

• When the desired language is shown, press the battery button to select. The device

will change the language and go back to the normal ﬂ ow screen.

7.4. ADJUSTING SETTING

IMPORTANT: After powering on Zen-Olite™, the startup sequence will take approximate-

ly 35 seconds. Speciﬁ ed oxygen level will be reached within 2 minutes of use.

• The device starts working in the previous setting.

• The device will deliver a pulse of oxygen at the beginning of each of your inhalation.

• Auto Mode: If no inhalation is detected for 60 seconds when in pulse mode, the “Check

Cannula” alarm will be activated and the device will automatically enter Auto-Mode and

continue to deliver oxygen at a rate of 18 breaths per minute. When an inhalation is

detected, the device will clear the “Check Cannula” alarm and exit Auto-Mode.

• Pulse mode of operation can be adjusted from 1.0 to 5.0 in 0.5 increments with the

and buttons.

IMPORTANT: If an air leak is suspected, leaks can be detected with a solution of soap

and water applied to the cannula-concentrator connection point and looking for bub-

bles.

The current setting and power source (external power or battery; battery icon also shows

approximate level of charge remaining) are shown on the display screen as shown in Fig.

7.

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7.5. ECO MODE

ECO Mode: While the Setting screen is shown, press and hold the Battery button for

approximately four seconds until it changes from “Pulse XX” to “Eco Mode”. Press and

hold the Battery button again to return to Pulse Mode. At startup, the device will always

default to standard Pulse Mode.

In standard Pulse Mode, the device will give you the same amount of oxygen every

breath, regardless of your breath rate. This can consume more battery power at higher

breath rates. In Eco Mode, the device will deliver a ﬁ xed volume of oxygen per minute

regardless of breath rate, and will give an extended battery duration.

7.6. 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 or .

• Next the number of charge cycles will be shown or

.

After the third push of the battery button, the display will alternate back to the main

screen showing the current ﬂ ow setting. It will also automatically exit the battery status

menu and go back to the main ﬂ ow setting display after approximately 15 seconds of no

buttons being pushed.

7.7. RESPONDING TO ALARMS

CAUTION: If you are unable to hear or see alarms, do not have normal tactile sensitivity,

or cannot communicate discomfort, consult your clinician before using this device.

Pressing the alarm mute button at any time will silence the buzzer. The length of the

mute period depends on the severity of the alarm (see Chapter 9 - Alarm Indicators). Dur-

ing this mute period, the mute LED will remain illuminated, indicating the alarm buzzer is

muted. Push the mute button again to un-mute alarms. Pressing the mute button when

there is no active alarm will mute any future medium or low priority alarms for eight hours.

See Chapter 9 - Alarm Indicators and Chapter 10 - Troubleshooting for additional informa-

tion on alarms.

IMPORTANT: The alarm system is tested during the startup sequence. You should see

all alarm lights brieﬂ y turn on and the audible alarm indicator chirp. If alarms are sus-

pected of mis-operating, contact your distributor for veriﬁ cation that alarms are working

correctly.

Fig. 7

Zen-Olite™ operating on battery

power. Zen-Olite™ running on external

power.

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7.8. TURNING OFF

CAUTION: Always turn o this device when not in use.

To turn the Zen-Olite™ Portable Oxygen Concentrator oﬀ , press and hold the power but-

ton. The device will chirp and the screen will display a shutdown message

for approximately ﬁ ve seconds, then go into low-power mode.

IMPORTANT: Do not disconnect the AC power supply and remove the battery at the

same time while the unit is running. Always use the power button to turn the device o .

Wait until the device has completely shut down before disconnecting from power and

removing the battery.

8. 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 United States Federal Aviation Administration (FAA). This is veriﬁ ed by the statement

on the back of the POC that states, in red text, “The manufacturer of this POC has deter-

mined this device conforms to all applicable FAA acceptance criteria for POC carriage

and use on board aircraft”. Prior to the ﬂ ight, you may be asked to show this text on the

POC to the ﬂ ight attendant.

8.1.2. Healthcare Provider Consultation

The FAA does not require a passenger to consult with a healthcare provider prior to us-

ing a Zen-Olite™ POC on board an aircraft. However, you, together with your healthcare

provider, may wish to discuss the following:

• The eﬀ ects of a pressurised cabin (cabin pressure altitude can reach 8,000 feet) on

your oxygen needs.

- Some Zen-Olite™ POC users need higher litre ﬂ ow or litre per minute (LPM) setting for

the Zen-Olite™ POC in the air because of cabin pressure altitude.

-Some Zen-Olite™ POC users who use a Zen-Olite™ POC occasionally on the ground

may need to use their Zen-Olite™ POC for the entire ﬂ ight because of cabin pressure

altitude.

• Your oxygen needs at the time of travel and whether your needs have changed since

the Zen-Olite™ POC was ﬁ rst prescribed or during the most recent consultation with a

healthcare professional.

• Certain button provisions in the Zen-Olite™ POC operating manual regarding oxygen

delivery, indicators, warnings, and alerts, as well as setting/changing litre ﬂ ow or LPM.

• All crewmembers (pilots and ﬂ ight attendants (F/A)) receive training regarding the han-

dling of in-ﬂ ight medical events. However, the FAA does not require that air carriers or

crewmembers provide medical assistance to passengers.

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