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

2010-8101CE-B December 2019 Page 10 of 36
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

2010-8101CE-B December 2019 Page 11 of 36
4.4 HUMAN MACHINE INTERFACE (HMI)
Symbol Meaning Operation
On / Off - Press once to turn “ON”
- Press and hold for one second to turn “OFF”
Mute Audible
Alarms Press this button to toggle between the
audible alarm being on or off.
Info /
Specifications Press this button to display the information of
the device.
Adjust Flow
Settings Press these buttons to adjust the flow setting up or down
Breath Detection
Indicator This blue indicator will light when a breath is
detected and a pulse dose is administered.
Alarm Indicator This yellow indicator will light when there is an
active alarm that may require response.

2010-8101CE-B December 2019 Page 12 of 36
4.5 SCREENS
HOME SCREEN
Icon Description
Flow Setting (from 1 to 5)
Battery Charge Level
Device Run Time
(H:MM) (single use)
Alerts are Muted
Alerts are Audible

2010-8101CE-B December 2019 Page 13 of 36
SCREENS (CONT.)
POWER SUPPLY SCREENS
•Device is ON
•Only battery attached
(Power Supply not attached)
•Battery level shows
percentage remaining
time remaining (H:MM)
•Device is ON
•Only battery attached
(Power Supply not attached)
•Battery level ≥ 25%
•Device is ON
•Only Power Supply attached
(No battery attached)
•Device is ON
•Battery attached; charging
Power Supply attached
•Battery level shows
percentage charged
time remaining to fully
charge battery (H:MM)
•Device is OFF
•Battery attached; charging
Power Supply attached
•Battery level shows
percentage charged
time remaining to fully
charge battery (H:MM)

2010-8101CE-B December 2019 Page 14 of 36
SCREENS (CONT.)
POWER SUPPLY SCREENS (CONT.)
•Device is OFF
•Only Power Supply attached
(No battery attached)
ALARM SCREENS (See §4.5 for all active alarm messages and actions)
Active Alarm in Audible Mode
Active Alarm in Mute Mode
Multiple Active Alarms
(screen will display scrolling
alarm messages)
INFORMATION SCREEN
Information includes:
Battery temperature, battery status,
molecular (sieve) temperature, molecular
(sieve) runtime, device model, device
temperature, device runtime, firmware
version, hardware version
Absence
o
f Breath
Check Cannula
Absence
o
f Breath
Check Cannula
Absence
o
f Breath
Check Cannula
BATTERY
TEMP: 20
Model: 8100-1550 Status: Good
MOLECULAR
TEMP: 26
Runtime: 5h Status: Good
DEVICE
TEMP: 27
Runtime: 5h Model: 855
Firmware Ver: Nidek_Nano_V1
Hardware Ver: Nidek_Nano_V1

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4.6 SAFETY FEATURES AND ALARMS
SAFETY FEATURES
Fire Break: This device is fitted with a metal fire break at the Oxygen
Product Outlet (Fig 1-2). This break will keep fire from entering the
device.
Auto Pulse Mode: This mode is enabled when no breath has been
detected for 15 seconds. The device will begin to pulse automatically
about once every 3 seconds until it detects a breath. Once it detects a
breath, it will exit auto pulse mode and begin delivering pulses based
on your breathing.
ALARMS
In the event of an alarm, the “Alarm Indicator” (§4.3) will light yellow
and activate the intermittent audible alarm (2 short beeps in 15 second
intervals).
WARNING
The device has an audible alarm to alert the user of
problems. In order that the alarm may be heard, the
maximum distance that the user can move away from it
must be determined to suit the surrounding noise level.
Whilewearingdeviceincarrying bag,ensurealarmcanbe
heard.

2010-8101CE-B December 2019 Page 16 of 36
SAFETY FEATURES AND ALARMS (CONT.)
ACTIVE ALARM MESSAGES
Message Display Explanation and Action
Absence of Breath
Check Cannula
No breath detected for more than 15 seconds.
Auto pulse mode enabled.
Check if cannula is connected firmly, not kinked, worn
correctly and breathing through nose.
Low Oxygen: < 87%
Contact Provider
Oxygen concentration is below 87% for more than 5
minutes (continuous).
Contact equipment provider for maintenance.
Low Oxygen: < 50%
Contact Provider
Oxygen concentration is below 50% for more than 5
minutes (continuous).
Device will shut down after 30 seconds.
Contact equipment provider for maintenance.
Low Battery
Charge Now Battery level is between 5% and 20%.
Connect AC/DC power supply to charge.
Battery Depleted
Connect to Adapter
Battery level is less than 5%.
Device will shut down after 10 seconds.
Replace battery or connect Power Supply to charge.
Battery too Cold
Warning: Consult IFU
Battery temperature is too low (< 0°C / 32°F).
Device will shut down after 10 seconds.
Move to a warmer environment and restart.
Battery too Hot
Only Use Adapter
Battery temperature is too high (> 65°C / 149°F).
Device will shut down after 10 seconds.
Disconnect battery and use Power Supply until battery
has cooled, then reattach and restart.
System too Cold
Warning: Consult IFU
System temperature is too low (< 0°C / 32°F).
Device will shut down after 10 seconds.
Move to a warmer environment and restart.
System Too Hot
Warning: Consult IFU
System temperature is too high (> 65°C / 149°F).
Device will shut down after 10 seconds.
Move to a cooler environment and restart.
Battery Exhausted
Contact Provider
Battery health is less than 50% (charge / discharge has
exceeded 500 cycles)
Replace battery soon (contact equipment provider).
Low Input Voltage
Check Adapter
Supplied input voltage is less than 17V.
Device will be powered by battery only.
Replace AC/DC Power Adapter (contact equipment
provider).

2010-8101CE-B December 2019 Page 17 of 36
SAFETY FEATURES AND ALARMS (CONT.)
Message Display Explanation and Action
Sieve Bed Fail
Contact Provider
Sieve bed does not work or has become invalid.
Device will shut down after 10 seconds.
Replace Sieve bed (Contact equipment provider).
Power Supply Fail
Contact Provider
System voltage is less than 10.5V.
Device will shut down after 10 seconds.
Attach fully charged battery.
Replace AC Power Supply (contact equipment provider).
Replace Sieve Bed
Contact Provider Sieve bed is expired / Sieve bed chip error.
Replace Sieve bed (Contact equipment provider).
Compressor Fail
Contact Provider
Compressor does not work.
Device will shut down after 10 seconds.
Contact equipment provider for maintenance.
Valve Check Fail
Contact Provider
Valve does not work (not switching).
Device will shut down after 10 seconds.
Contact equipment provider for maintenance.
Cooling Fan Fail
Contact Provider
Fan does not work.
Device will shut down after 10 seconds.
Contact equipment provider for maintenance.
Gas Supply Fail
Contact Provider
Product gas supply is abnormal.
Device will shut down after 10 seconds.
Contact equipment provider for maintenance.
Sys Startup Fail
Contact Provider
Concentration does not reach 87% within startup period.
Device will shut down after 10 seconds.
Contact equipment provider for maintenance.
Gas Obstruction
Contact Provider
Output gas tube is blocked / cannula is kinked.
Device will shut down after 30 seconds.
Contact equipment provider for maintenance.
Breath Sensor Fail
Contact Provider
Breath sensor does not work.
Device will shut down after 30 seconds.
Contact equipment provider for maintenance.
Oxygen Sensor Fail
Contact Provider
Oxygen sensor does not work.
Device will shut down after 30 seconds.
Contact equipment provider for maintenance.
Gas Delivery Fail
Contact Provider
Oxygen delivery has not been detected.
Device will shut down after 30 seconds.
Contact equipment provider for maintenance.
Tank Pressure Fail
Contact Provider
Tank pressure is abnormal.
Device will shut down after 30 seconds.
Contact equipment provider for maintenance.

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4.7 PERFORMANCE AND SPECIFICATIONS
The performance of the device (especially the oxygen concentration) is
quoted at 21°C (70°F) and one atmosphere. The specifications may
change with temperature and altitude.
Model 855
Description Nuvo Nano Oxygen Concentrator
Power Supply AC Input 100 to 240 VAC / 50 to 60 Hz
Rechargeable Battery 14.54VDC Voltage / 6.8Ah Rated Capacity
User Interface 2.8 inch large LCD color display
Average Oxygen Content 87% to 96% at all settings
Breathing Frequency 10 to 40 breaths per minute
Inspiratory Trigger Sensitivity ≤0.12 cm H2O
Maximum Outlet Pressure 25 PSI
Dimensions (L x W x H) 22.6cm x 8.9cm x 16.5cm
(8.3 in x 3.5 in x 6.5 in)
Weight 2.1 kg (4.7lbs)
Noise Level 49 dBA (on setting 2)
Battery Duration Up to 4 hours
Battery Charging Time Not more than 4 hours
Protection Class Class II
Components: Type BF
Ingress Protection* IP22
* Complies with EN 60529:2001 + A2:2014 rating of IP22; enclosure protects internal
electrical components against vertically falling water drops at a 15°tilt and for
particulates larger than 12.5mm while in carrying bag.
* Complies with EN 60601-1:2006 [11.6.3]; enclosure protects internal electrical
components against spilling of a glass of water

2010-8101CE-B December 2019 Page 19 of 36
PERFORMANCE AND SPECIFICATIONS (CONT.)
FLOW CONTROL SETTINGS AND PULSE VOLUMES
Settings 1 2 3 4 5
Breath
Rate Pulse Volumes (ml)
10 21 42 63 84 100
15 14 28 42 58 66.7
20 10.5 21 31.5 42 50
25 8.4 16.8 25.2 33.6 40
30 7 14 21 28 33.3
35 6 12 18 24 28.6
40 5.3 10.5 15.8 21 25
±15% at
Standard Temperature and Pressure, dry (STDP)*
± 25% over the rated environmental range
* STDP is 101.3kPa at an operating temperature of 20°C, dry
Materials in direct or indirect contact with the patient
Item Material
Concentrator enclosure PC+ ABS
Printed labels Polycarbonate
HMI PET
Oxygen product outlet Aluminum
AC Power Supply PVC
Cabinet air filter Stainless Steel Screen
Intake Filter 100% Wool Felt
Product Filter PP + Glass Fiber
Pipe/Tubing Aluminum, PVC, polyurethane
and/or silicone

2010-8101CE-B December 2019 Page 20 of 36
4.8 ACCESSORIES AND SPARE PARTS
The accessories used with the device must be oxygen compatible,
designed for oxygen therapy use, biocompatible and comply with the
general requirements of the FDA QSR or the 93/42/EEC European
Directive, or any other applicable regulatory requirements.
Theaccessoriesbelow,availablefromNidek MedicalProducts, Inc.and
our distributors, comply with these requirements.
Contact your equipment supplier to obtain these accessories.
Item Part Number
Adult Cannula
With 2m (7ft) of tubing, rated at 6 LPM 9012-8780
Carrying Bag 8100-1650
Silicone Sleeve 8100-1675
AC / DC Power Adapter 8100-1540
Battery 8100-1550
Intake Filter (set of 5) 8100-1181
Cabinet Filter 8100-1031
WARNING
Improper patient connection to and use of the cannula
may result in injury, including strangulation. To reduce
the risk of this occurring, avoid situations that might
cause the cannula or hose to become entangled about
the patient’s neck and do not attach more than 7.6m (25
ft) in length of tubing.
CAUTION Ears, noseandneckmay becomeirritatedafterprolonged
exposure to the cannula. For relief, only a water-based
lubricant is recommended.
CAUTION The use of certain administration accessories and/or
spare parts which are not recommended by the
manufacturer may reduce its performance and void the
manufacturer’s responsibility.
NOTE Cannula should be rated for at least 6 LPM