Nidek Medical Nano User manual

2010-8101CE-B December 2019
Nano
PORTABLE OXYGEN CONCENTRATOR
INSTRUCTIONS FOR USE
For Nuvo Nano, model 855
(and variants thereof)
[Original language is English]

2010-8101CE-B December 2019

2010-8101CE-B December 2019 Page 3 of 36
TABLE OF CONTENTS
1 SYMBOLS............................................................................................4
2 GENERAL WARNINGS AND PRECAUTIONS.........................................6
3 CONTRAINDICATIONS ........................................................................7
4 YOUR DEVICE......................................................................................8
4.1 INTENDED USE AND OPERATION.................................................8
4.2 DEVICE FEATURES ........................................................................9
4.3 POWER SUPPLY..........................................................................10
4.4 HUMAN MACHINE INTERFACE (HMI).........................................11
4.5 SCREENS.....................................................................................12
4.6 SAFETY FEATURES AND ALARMS................................................15
4.7 PERFORMANCE AND SPECIFICATIONS.......................................18
4.8 ACCESSORIES AND SPARE PARTS...............................................20
5 UNPACKING AND INSPECTION.........................................................21
5.1 ENVIRONMENTAL STORAGE CONDITIONS.................................21
6 OPERATION......................................................................................22
6.1 ENVIRONMENTAL OPERATING CONDITIONS.............................22
6.2 TRAVEL.......................................................................................23
6.2 START UP....................................................................................24
6.3 SHUT DOWN...............................................................................27
6.4 TROUBLESHOOTING...................................................................28
7 CLEANING AND MAINTENANCE.......................................................29
7.1 CLEANING...................................................................................29
7.2 MAINTENANCE...........................................................................30
8 DISPOSAL..........................................................................................32
9 EMC INFORMATION.........................................................................33
10 CONFORMITY WITH EN 60601-1....................................................35

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1 SYMBOLS
These symbols are found in this Instructions for Use (IFU), on the
device and shipping cartons, and on the device labels.
Symbol Meaning
WARNING – A hazard or unsafe practice that can result in
serious injury or death if conditions are not avoided.
CAUTION - A hazard or unsafe practice that can result in
minor injury and / or property damage if conditions are
not avoided.
NOTE Note – Information important enough to emphasize or
repeat
℞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.
Complies with Applicable EU Directives; Including Medical
Device Directive
Authorized Representative in the European Community
Do Not Smoke
Do Not Expose to Open Flames
Do Not Expose to Oil or Grease
Manufacturer Name and Address
Type BF Device
Class II Protection
IP22 Protection from vertically falling water drops while in
carrying bag

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SYMBOLS (CONT.)
Tools Required / Technician Only
Do Not Dispose of as Unsorted Municipal Waste
Keep in Dry conditions
Direct Current (DC)
Date of Manufacture
Job Number (Lot / Batch number)
Serial Number
Catalog Number (Model number plus variant)
Refer to Technical Information / Service Manual
Refer to Instructions for Use / User’s Guide
Keep in Vertical Position
FRAGILE – Handle with Care
Temperature Limits for storage
Humidity Limits for storage
Symbols used for the operation of the device can be found in §4.3.

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2 GENERAL WARNINGS AND PRECAUTIONS
WARNING 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.
WARNING
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.
WARNING
Oxygen accelerates the combustion of flammable
substances, therefore, DO NOT useoil, grease, petroleum
based or other flammable products:
•on the device
•on the accessories (ex. cannula)
•on the patient’s face / neck
•to lubricate fittings, connections, tubing, etc.
WARNING
A back up oxygen source is recommended for power
outages or mechanical problems.
The patient is responsible for making arrangements for
alternate oxygen supply during travel.
WARNING
The settings of the Nano might not correspond with
continuous flow oxygen.
The settings of the Nano do not correspond with other
brands or models of oxygen concentrators.
Please see the specifications on pg 18 to determine your
setting.
WARNING Forpatientsafetyandbenefit,DONOTmodifythissystem
or equipment in any way.

2010-8101CE-B December 2019 Page 7 of 36
GENERAL WARNINGS AND PRECAUTIONS (CONT.)
WARNING Only persons who have read and understood this entire
manual should be allowed to operate the device.
℞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.
3 CONTRAINDICATIONS
WARNING 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).
CAUTION In certain circumstances, oxygen therapy can be
hazardous. Please seek medical advice before using this
device.

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4 YOUR DEVICE
4.1 INTENDED USE AND OPERATION
The Nuvo Nano Portable Oxygen Concentrators are used to provide
oxygen enriched product gas for patients, adolescent to geriatric,
suffering from health conditions that cause low levels of oxygen in the
blood (hypoxaemia). The Nano is small, portable and may be used in
home, institution and various mobile environments.
WARNING
To ensureyour safety, useonly after oneor more settings
have been individually determined or prescribed for you
at your specific activity levels – AND – only use the
accessories that were used when your settings were
determined.
WARNING While undergoing oxygen therapy, if you feel discomfort
or experience a medical emergency, seek medical
assistance immediately.
The Nuvo Nano (Nano) begins its operation with air being pulled into
the external air intake filter. This filtered air enters the compressor via
a fine filter. Pressurized air then exits the compressor. Next, an
electronicvalvesystemdirectstheairintooneoftwotubesthatcontain
molecular sieve (sieve beds). The molecular sieve adsorbs (physically
attracts) thenitrogen fromtheairasitispushed throughthesievebeds,
this process is called pressure swing adsorption (PSA). As one tube is
generating the product gas, the other is being purged of the adsorbed
nitrogen. After passing through the oxygen storage tank, the rate of
product gas being delivered to the patient is set by a restricting orifice
and pulse dose valve based upon detection of a breath. It then passes
through a fine particle filter and thru a sensor that detects the oxygen
concentration of the product gas before it exits the device through a
flame-resistant outlet. Once the product gas leaves the device, it
travels to the patient via oxygen tubing and a cannula inserted in the
nose.

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4.2 DEVICE FEATURES Front panel (Fig. 1)
1 – Human Machine
Interface (HMI)
2 – Oxygen Product Outlet
3 – Cabinet Filter
4 – Air Exhaust
Intake Filter not pictured –
accessed after removing
Cabinet Filter (Fig. 1-3)
See pg. 29 for replacing.
Rear panel (Fig. 2)
5 – Battery
6 – Battery Release
7 – Power Supply Input
Technical Label not
pictured – located on
bottom of device.
Figure 1
Figure 2
1
2
3
4
5
6
7

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4.3 POWER SUPPLY
BATTERY (PN 8100-1550)
One power supply option is our standard
lithium ion battery. When fully charged, the
battery can serve for up to 4 hours of
operation.
To recharge the battery, install it in the Nano
and connect the AC/DC Power Supply
(below). Fully charging will take no more
than 4 hours.
AC POWER SUPPLY
Another power supply option is our AC Power Supply (Power Supply)
which combines the AC/DC Power Adapter (Adapter) and a country
specific AC Cord (Cord) inserted in a functioning wall outlet. The Power
Supply automatically adapts to input voltages from 100V to 240V (50-
60 Hz) permitting use with most power sources throughout the world.
Toattachthesupply tothedevice:1)insert CintoD, 2)connectadapter
B into Power Supply Input (Fig 2-7), 3) insert A into wall outlet.
Description Part Number
Adapter 8100-1540
US Cord 4500-1311
EU Cord 4500-1330
UK Cord 4500-1341
** Additional country specific
cords available upon request.
WARNING
DO NOT use power supplies or power cables other than
the ones listed above.
The use ofnon-specified supplies andcables maycreate a
safety hazard and / or impair device performance.
CAUTION It is the responsibility of the patient to periodically check
the battery and replace as necessary. Nidek Medical
assumesnoliabilityfor personschoosingnotto adhereto
manufacturer recommendations.
Figure 3