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3 .2 . CAUTIONS OVERVIEW

1 . 

Keep away from heat sources (fireplaces, 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 difficult 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 flow 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 specified oxygen concentration purity until it has been in 

use for up to 2 minutes at set flowrate. 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 specified 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 humidifier or nebuliser. If a humidifier or 

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

may be damaged.

D.SPEC.26.4 Zen-O lite - Mode d'emploi_EN

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Summary of Contents for Zen-O lite RS-00600

Page 1: ...Zen O lite User manual D SPEC 26 4 Zen O lite Mode d emploi_EN v 09 09 2021 1 46...

Page 2: ...oxygen concentrator Zen O lite Oxycure oxygen concentrator Zen O not in the picture Oxycure Stationary oxygen concentrator Oxycure oxygen concentrator Kr ber Oxycure cylinders gaseous oxygen Oxycure B...

Page 3: ...o urgent installations or repairs on our medical devices Call to guard service 1 Leave a message on the answering machine with your name and phone number and give a brief reason of your call 2 The cus...

Page 4: ...User Manual Portable Oxygen Concentrator Models RS 00600 RS 00600C GCE HEALTHCARE D SPEC 26 4 Zen O lite Mode d emploi_EN v 09 09 2021 4 46...

Page 5: ...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 Cann...

Page 6: ...11 3 Service Life 29 11 4 Service Connector 30 12 Device Repair and Disposal 30 12 1 Repair 30 12 2 Sieve Modules Replacement Instructions 30 12 3 Disposal 31 13 Warranty 31 14 Trademarks and Disclaim...

Page 7: ...ral 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...

Page 8: ...effective use of the device IMPORTANT Statements calling attention to additional significant information about the device or a procedure 2 INTENDED USE Zen O lite portable oxygen concentrator is inte...

Page 9: ...ys 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 flow of...

Page 10: ...utic 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 specific activity levels by...

Page 11: ...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 sy...

Page 12: ...n 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 a...

Page 13: ...ce 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 Us...

Page 14: ...attery 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...

Page 15: ...pply DC power supply 6 1 ACCESSORIES LIST Only use power supplies adapters or accessories specified in this manual Using ac cessories that are not specified may create a hazard and or negatively affec...

Page 16: ...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 t...

Page 17: ...inal capacity Replace the battery when the reduced battery life is affect ing your mobility IMPORTANT The DC power supply should be utilised on vehicles with the proper power output rating IMPORTANT T...

Page 18: ...the backlight on the display screen will remain off Pressing any button will turn the backlight on briefly The backlight will also remain activated during an un muted alarm condition 7 1 CONNECTING A...

Page 19: ...startup sequence will take approximate ly 35 seconds Specified oxygen level will be reached within 2 minutes of use The device starts working in the previous setting The device will deliver a pulse o...

Page 20: ...he display will alternate back to the main screen showing the current flow setting It will also automatically exit the battery status menu and go back to the main flow setting display after approximat...

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