Nidek Medical Mark 5 Nuvo Lite Series Instructions For Use Manual Download Page 1

______________________________________________________________________________________________________________ 

2010-8401CE-E 

February 2018 

Page 1 of 8 

EN 

INSTRUCTIONS FOR USE

Mark 5 Nuvo Lite Family  

(Nuvo Lite and Nuvo Lite 3) 

OXYGEN CONCENTRATOR 

For models: 525, 535, 925 and 935 

(and variants thereof) 

[Original language is English]

This unit is not a life-support device.  Geriatric, 
pediatric, or any other patient unable to 

communicate discomfort while using this device 
should receive additional monitoring. 

This device supplies highly concentrated oxygen 

enriched product gas that promotes rapid 
burning.   
DO NOT allow smoking or open flames within the 

same room of this device or the administration 
accessory (cannula).  Failure to observe this 
warning can result in severe fire, property 

damage, and / or cause physical injury or death. 

Oxygen accelerates the combustion of flammable 
substances.  DO NOT use oil, grease, petroleum 

based or other flammable products on the 
device, the administration accessory (cannula) or 
the patient’s face / neck. 

Only persons who have read and understood this 
entire manual should be allowed to operate the 

device.

CONTRAINDICATIONS - Those who continue to 
smoke (because of the increased fire risk and the 

probability that the poorer prognosis by smoking 
will offset the treatment benefit). 

Only

Federal Law (US) restricts this device to sale by, or 

on the order of, a licensed physician. This oxygen 
concentrator should be used only under the 
supervision of a licensed physician. 

Contents 

1

GLOSSARY OF SYMBOLS ................... 2

2

YOUR DEVICE ....................................... 2

2.1

Intended Use and Operation .............. 2

2.2

Device Features ................................. 2

2.3

Alarms and Safety Features............... 3

2.4

Device Performance and 

Specifications ............................................... 3
2.5

Accessories and Spare Parts .............. 4

3

UNPACKING AND INSPECTION ......... 4

4

INSTALLATION AND OPERATION .... 4

4.1

Installation ......................................... 4

4.2

Start-Up ............................................. 5

4.3

Shut Down ......................................... 5

5

CLEANING AND MAINTENANCE ...... 5

5.1

Cleaning ............................................ 5

5.2

Maintenance ...................................... 5

6

DISPOSAL ............................................... 6

6.1

Method for Waste Disposal ............... 6

6.2

Disposing of the Device .................... 6

7

TROUBLESHOOTING ........................... 6

8

EMC INFORMATION............................. 7

9

CONFORMITY WITH EN 60601-1 ........ 8

Nuvo Lite (Model 925) shown for reference.

Summary of Contents for Mark 5 Nuvo Lite Series

Page 1: ... flammable products on the device the administration accessory cannula or the patient s face neck Only persons who have read and understood this entire manual should be allowed to operate the device CONTRAINDICATIONS Those who continue to smoke because of the increased fire risk and the probability that the poorer prognosis by smoking will offset the treatment benefit Only Federal Law US restricts...

Page 2: ...e used when your settings were determined While undergoing oxygen therapy if you feel discomfort or experience a medical emergency seek medical assistance immediately The Mark 5 Nuvo Lite Family begins their operation with air being pulled into the external air intake filter This filtered air enters the compressor via a suction resonator and fine filter Pressurized air then exits the compressor an...

Page 3: ...pplied the device has a Blockage Alarm A continuous audible alarm and both indicator lights will be lit immediately in the event the flow of oxygen to patient becomes blocked Malfunction detection If low pressure occurs due to a mechanical failure the indicator light will flash yellow and a continuous audible alarm will actuate If any of the above alarm conditions occur press the Power Switch Fig ...

Page 4: ...mance and void the manufacturer s responsibility Spare Parts Part Ref Cabinet air filter Fig 2 9 8400 1025 Inlet Filter Under Fig 2 9 8400 1180 Ventilation Grill Fig 2 9 8400 0108 Casters 8300 8068 Mains Cable Wrap 8400 0022 Please consult the Nuvo Lite Maintenance Manual PN 2010 8405 for instructions on replacing any above spare parts 3 UNPACKING AND INSPECTION The Oxygen Concentrator is packaged...

Page 5: ...s or other by placing the orifice s on the surface of a glass of water The flow should disturb the surface of the water 6 Adjust the nasal cannula to suit your face 4 3 Shut Down At the end of the treatment press the Power Switch Fig 1 3 to the O OFF position to stop the device The oxygen enriched air flow continues for approximately one minute after the device is stopped Make sure during operatio...

Page 6: ...vidual product markings for disposal Furthermore as part of the marking directive 93 42 EEC the serial number of the device disposed of must be sent to Nidek Medical if the unit has the marking 7 TROUBLESHOOTING Observations Possible Causes Solutions The I O ON OFF button is in the I ON position but the device does not operate Mains cable Fig 2 8 is not correctly plugged into the wall outlet Check...

Page 7: ...______________________________________________________________________________________________________________ 2010 8401CE E February 2018 Page 7 of 8 EN 8 EMC INFORMATION ...

Page 8: ...eriodic servicing by an approved technician do not comply with the manufacturer s specifications the manufacturer is not responsible in the event of an accident or non performance This device complies with the requirements of the FDA Quality System Regulation and 93 42 EEC European directive but its operation may be affected by other devices being used nearby such as diathermy and high frequency e...

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