GCE Zen-O Kasutusjuhend

Bränd: GCE

Mudel: Zen-O

Tüüp: Kasutusjuhend

User Manual

Portable Oxygen Concentrator

Models: RS-00500 & RS-00500C

GCE HEALTHCARE

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

Norsk . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .44

Dansk . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .86

Suomi . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .128

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English

User manual: Zen-O™ Portable Oxygen Concentrator (Models: RS-00500 & RS-00500C)

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. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

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

6.4. Pull Cart . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

6.5. Connecting a Humidiﬁ er . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

7. Operating Zen-O™ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

7.1. Connecting Nasal Cannula . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

7.2. Turning On . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

7.3. Choosing a Preferred Language . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

7.4. Adjusting Setting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

7.5. ECO Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

7.6. Battery Button . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

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English

User manual: Zen-O™ Portable Oxygen Concentrator (Models: RS-00500 & RS-00500C) 7.7. Responding to Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

7.8. Turning O . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

8. Traveling with the Zen-O™ POC by Air . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

8.1. Passenger Pre-ﬂ ight Preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

8.2. Boarding and In-ﬂ ight Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22

8.3. Transportation Security Administration (TSA) Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24

8.4. Placing your device in Airplane Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24

9. Alarm Indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25

9.1. Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26

10. Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

11. Maintenance and Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30

11.1. Routine Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30

11.2. Cleaning and Disinfection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30

11.3. Service Life . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30

12. Device Repair and Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

12.1. Repair . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

12.2. Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

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

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

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

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

15. Technical Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34

15.1. Electromagnetic Compatibility (EMC) Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37

15.2. FCC warning statement: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40

15.3. EU RED Article 10(10) Restrictions on Use for Model RS-00500C: . . . . . . . . . . . . . . . . . . . . . . . 41

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™ Portable

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 operation of

this system, contact your distributor.

1.1. GENERAL INFORMATION

This user manual provides information for users of the Zen-O™ 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™ Portable Oxygen Concentrator.

"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 ﬁ 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 haz-

ards.

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

exercised by the practitioner and/ or patient for the safe and e 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™ portable oxygen concentrator is intended to provide supplemental oxygen to pa-

tients 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-O™ 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-O™ 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 pulse settings of Zen-O™ Portable Oxygen Concentrator RS-00500/RS-00500C

might not correspond with continuous ﬂ ow oxygen.

4. The settings of other models or brands of portable oxygen concentrators do

not correspond with the settings of Zen-O™ Portable Oxygen Concentrator

RS-00500/RS-00500C.

5. Wind or strong drafts can adversely a ect accurate delivery of oxygen therapy.

6. Geriatrics or any other patient unable to communicate discomfort can require additional

monitoring to avoid harm.

7. Smoking (including e-cigarettes) during oxygen therapy is dangerous and is likely to re-

sult 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 concentrator or

any oxygen carrying accessories. If you smoke, you must always turn the oxygen con-

centrator 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

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 device

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 oxygen

will make the materials ﬂ ammable. Turn the concentrator o 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.

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

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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 tempera-

ture range of 5°C (41°F) to 40°C (104°F), or outside the humidity range of 5% to 93%

may adversely a 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 en-

vironment 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

storage temperatures to operating temperature before use.

17. Always ensure at least one 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 accesso-

ries used prior to use. To ensure you are receiving the therapeutic amount of oxygen 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. Disassembly

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 di 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 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 nebuliser. If a nebu¬liser is used with this

device, performance may be diminished and the device may be damaged.

16. A humidiﬁ er should only be used with this device when in continuous ﬂ ow mode

mode. Follow the humidiﬁ er manufacturer’s user instructions.

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17. Always follow cannula manufacturer’s instructions for proper use.

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

clinician to determine how often the cannula should be replaced.

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

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

sories list.)

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

battery in a cool, dry place.

22. 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.

23. Always turn o this device when not in use.

24. Always disconnect power and turn o this device before cleaning. See Chapter 11 -

Maintenance and Cleaning.

25. 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.

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

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

and/or inadvertent setting changes.

28. Keep the device away from pets and pests.

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

ditions.

30. Always use in a well ventilated location.

31. Always follow the maintenance schedule as speciﬁ ed in Section 11.1. Routine Mainte-

nance.

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

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

34. 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.

35. 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. This oxygen concentrator can operate in either continuous ﬂ ow mode or pulse deliv-

ery mode. Your clinician will provide you with speciﬁ c instructions for both modes if

applicable. See Chapter 15 - Technical Description.

4. 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 operate

this device if unsure of its operation or function. Contact your home oxygen provider for

assistance or further information.

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5. PRODUCT DESCRIPTION

5.1. SCHEMATIC DESCRIPTION

Green LED - power on

Power key

Display screen

Battery indicator Alarm mute key

Alarm mute indicator

Red LED - warning

Yellow LED - warning

Pulse/Flow setting

selection keys

Nasal cannula port

Mode key

Fig. 1

Battery

Air intake

Power

input

Power

input

Exhaust

vent

Battery release

button

Battery cover/Han-

dle

• 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.

12/178

6. GENERAL INSTRUCTIONS BEFORE

USE

A variety of accessories can enhance the port-

ability and use of the Zen-O™ Portable Oxygen

Concentrator. In addition to the device, the pack-

age 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 exhib-

it 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

• Pull Cart

6.1. ACCESSORIES LIST

Only use power supplies/adapters or accessories

speciﬁ ed in this manual. Using accessories that

are not speciﬁ ed may create a hazard and/or neg-

atively a ect the performance of the device.

• Rechargeable battery (RS-00501)

• AC power supply – European cord (RS-00520)

• AC power supply – United Kingdom cord (RS-00521)

• AC power supply – North America cord (RS-00522)

• AC power supply without cord (RS-00510)

• DC power supply (RS-00508)

• Carry bag (RS-00509)

• Pull cart (RS-00507)

• European power cord (RS-00504)

Fig. 2

Fig. 3

Power supply

13/178

12/178

• 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)

• Humidiﬁ er kit (RS-00534)

• 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™ 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. Two batteries can be placed in the concentrator

battery slots or one battery can be placed in either slot.

WARNING: Always ensure that at least one battery is inserted before using this device.

IMPORTANT: Optional power cords are available for various global use and travel (see

Section 6.1. Accessories List).

6.2.1. Charging the Battery/Batteries

CAUTION: Only charge the battery in this device or in an approved charger. (See Section

6.1. Accessories List.)

• Prior to using the device for the ﬁ rst time, install one or two batteries as shown in Fig.

2. each battery will latch when fully seated.

• Connect the AC/DC power supply by plugging the round connector into the power in-

put 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 inserting the power supply to a wall outlet.

• The display shows .

The charger is universal and supports a wide variety 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 device can run for up to 4 hours with one battery or 8 hours with two batteries at set-

ting 2 in pulse mode, at 18 breaths per minute. In continuous mode at setting 2 the device

can run for up to 0.75 hours on one battery and 1.5 hours on two batteries.

14/178

IMPORTANT: Battery run time may vary based on breathing rate, age of battery, and

environmental conditions. See displayed text on device 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 - Troubleshooting for more

information.)

IMPORTANT: While the concentrator is powered from the DC power supply and operat-

ing in continuous mode at setting 2, the battery will not charge.

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 Portable Oxygen Concentrator.

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.

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.

6.3. NASAL CANNULA

Only use a nasal cannula with the following speciﬁ cations:

• Length: 1.2m (4ft), 2.1m(7ft), 7.6m(25ft) or 15.2m (50ft)

• 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

15/178

14/178

Fig. 4

• Meets substance compatibility of IEC/EN

60601-1

A 15.2m (50ft) cannula must only be used when

device is operating at a continuous mode set-

ting.

CAUTION: Only use approved accessories with

this device. Refer to the approved accessories

guide for a complete list of accessories and can-

nula 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.

Contact your distributor for updated information

and accessories or if additional, optional, or re-

placement accessories are needed.

6.4. PULL CART

When using the device with a pull cart, attach

and secure the concentrator with the straps as

shown in Fig. 4.

IMPORTANT: It is recommended that patients

use the pull cart to transport the device when-

ever possible.

6.5. CONNECTING A HUMIDIFIER

WARNING: A humidiﬁ er may only be used in continuous mode!

Do not use a humidiﬁ er while the POC is in pulse mode or eco mode!

Do not overﬁ ll the humidiﬁ er!

Use humidiﬁ er only if prescribed by a clinician!

To attach the humidiﬁ er:

• Remove the cover on the humidiﬁ er bottle

• Fill the humidiﬁ er with boiled tap water which has

been left to cool or distilled water

• Fill the humidiﬁ er bottle to the level speciﬁ ed by the

humidiﬁ er bottle manufacturer mark then replace

the cover.

• Attach the angle adapter directly to the humidiﬁ er

bottle and - Place the assembled humidiﬁ er bottle

into humidiﬁ er bag and attach the humidiﬁ er bag to

the pull cart.

Oxygen

adapter

hose

Angle

adapter

Humidiﬁ er

Cannula

Humidiﬁ er

bag

16/178

• Connect the oxygen adapter hose (max 50 cm) to the angle adapter and ﬁ t the other

end to the oxygen outlet on the concentrator. Make sure all connections are secure.

• Connect the nasal cannula to the humidiﬁ er bottle outlet and ensure oxygen is ﬂ owing

through the cannula.

• The concentrator and the humidiﬁ er should always be used in an upright position to

prevent water from entering the nasal cannula.

NOTE: Using only speciﬁ ed cannula.

7. OPERATING ZENO™

IMPORTANT: Read Chapter 3 - Safety Instructions before using this device.

Zen-O™ Portable Oxygen Concentrator is designed for ease of use, with all functions ac-

cessed through just a few buttons on the control panel.

The device should be carried in its carry bag, placed on a cart and used when positioned

upright on a table 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 sequences, the backlight on the dis-

play screen will remain o . Pressing any button will turn the backlight on brieﬂ y. The

backlight will also remain activated during an

un-muted alarm condition.

7.1. CONNECTING NASAL CANNULA

CAUTION: Replace the cannula on a regular basis.

Check with your home oxygen provider or clini-

cian to determine how often the cannula should

be replaced.

CAUTION: Always follow cannula manufacturer’s

instructions 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™ 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 pa-

tient. Ensure cannula is connected securely and it has been

fully inserted.

play screen will remain o . Pressing any button will turn the backlight on brieﬂ y. The

Cannula

port

Fig. 5

Fig.6

17/178

16/178

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

Green LED - indicates device is on. The green LED will then stay lit.

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 about

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 mode 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™, the startup sequence will take approximately 35

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

• The device starts working in the previous setting.

Use the mode button to alternate between pulse mode and continu-

ous ﬂ ow mode .

• In pulse mode, 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.

• In continuous ﬂ ow mode, the device will provide a continuous ﬂ ow of oxygen, but will

consume more power and have a shorter battery life.

Setting the mode can be done as follows:

• Pulse mode of operation can be adjusted from 1.0 to 6.0 in 0.5 increments with the

and buttons.

• Continuous mode of operation can be adjusted from 0.5 to 2.0 in 0.5 increments with

the and buttons.

18/178

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.

IMPORTANT: Flow can be veriﬁ ed by putting the oxygen concentrator in continuous

mode and placing the end of the nasal cannula under the surface of a half full cup of

water and looking for bubbles.

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.

7.5. 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 or batteries. Repeat-

edly pushing the button will cycle through all the information.

Fig. 7

Continuous ﬂ ow mode

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

Zen-O™ operating

on battery power. Zen-O™ running

on external power.

Pulse mode

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