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INSTRUCTIONS FOR USE
Mark 5 Nuvo Family
(NUVO, NUVO 8 & NUVO 10)
OXYGEN CONCENTRATOR
For models: 505, 565, 585, 595, 905, 965, 985 and 1005
[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).
Federal Law (US) restricts this device to sale by, or
℞
on the order of, a licensed physician. This oxygen
Only
concentrator should be used only under the
supervision of a licensed physician.
______________________________________________________________________________________________________________
2010-2324CE-I
(and variants thereof)
October 2023
NUVO 10 (Model 1005) shown for reference.
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
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
EN
Page 1 of 8
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Summary of Contents for Nidek Medical Nuvo
-
Page 1: Table Of Contents
For models: 505, 565, 585, 595, 905, 965, 985 and 1005 (and variants thereof) [Original language is English] NUVO 10 (Model 1005) shown for reference. This unit is not a life-support device. Geriatric, Contents pediatric, or any other patient unable to communicate discomfort while using this device GLOSSARY OF SYMBOLS .... -
Page 2: Glossary Of Symbols
YOUR DEVICE Technical Label 9 – Mains Cable Intended Use and Operation The Mark 5 Nuvo Family (Nuvo, Nuvo 8 and Nuvo 10) Figure 2 Oxygen Concentrators are used as a means of providing continuous oxygen enriched product gas for patients, adolescent to geriatric, suffering from health conditions Rear panel (Fig. -
Page 3: Alarms And Safety Features
One tubeaxial fan cools the compressor compartment and Oxygen product outlet (Fig 1-3) SS or Brass additional fans cool the heat exchanger coil for the Nuvo Flow adjustment knob (Fig 1-4) 8 and Nuvo 10 models (585, 985, 595, and 1005). -
Page 4: Accessories And Spare Parts
Please consult the Nuvo Family Service Manual (PN 2010- 2329) for instructions on replacing any above spare parts. of the FDA Quality System Regulation or the European Medical Device Regulation, (EU) 2017/745, or any other applicable regulatory requirements. -
Page 5: Start-Up
Shut Down Device must have power to operate. In the event of power loss and for continued operation a backup source is At the end of the treatment, press the Power Switch (Fig recommended. 1-1) to the “O” (OFF) position to stop the device. The Do not use in a specifically magnetic environment (MRI, X- oxygen enriched air flow continues for approximately ray, etc.). -
Page 6: Disposal
2017/745, the serial number of the device disposed of which are designated as being the manufacturer’s must be sent to Nidek Medical if the unit has the responsibility or by the manufacturer as repairable. marking. -
Page 7: Emc Information
EMC INFORMATION be powered from an uninterruptable power supply (UPS). ______________________________________________________________________________________________________________ 2010-2324CE-I October 2023 Page 7 of 8... -
Page 8: Conformity With En 60601-1
CB and other portable devices, microwave ovens, induction plates or even remote-control toys or any other electromagnetic interferences which exceed the levels specified by the EN 60601-1-2 standard. Nidek Medical Products, Inc. 3949 Valley East Industrial Drive Birmingham, Alabama 35217 U.S.A.
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