Nidek Medical Mark 5 Nuvo Series User manual

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2010-2324CE-G March 2022 Page 1 of 8
EN
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
(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
10
(Model
1005
)
shown for reference.

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2010-2324CE-G March 2022 Page 2 of 8
Figure 1
Figure 2
Figure 3
1 GLOSSARY OF SYMBOLS
ON (Power switched on)
OFF (Power switched off)
Manufacturer Name and Address
Type B Device
Class II Protection
IPX1 Protection from vertically falling water drops
Do Not Smoke
Do Not Expose to Open Flames
Do Not Expose to Oil or Grease
Tools Required / Technician Only
Refer to Technical Information / Service Manual
Refer to Instructions for Use / User’s Guide
Keep in Vertical Position
FRAGILE – Handle with Care
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 – Information important enough to
emphasize or repeat
2 YOUR DEVICE
2.1 Intended Use and Operation
The Mark 5 Nuvo Family (Nuvo, Nuvo 8 and Nuvo 10)
Oxygen Concentrators are used as a means of providing
continuous oxygen enriched product gas for patients,
adolescent to geriatric, suffering from health conditions
that cause low levels of oxygen in the blood
(hypoxaemia).
To ensu
re y
our safety, use
only after one or 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.
While undergoing oxygen therapy, if you feel discomfort
or experience a medical emergency, seek medical
assistance immediately.
The Mark 5 Nuvo 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
and passes through a heat exchanger, which reduces the
temperature of the compressed air. Next, an electronic
valve system directs the air into one of two tubes that
contain molecular sieve (sieve beds). The molecular
sieve adsorbs (physically attracts) the nitrogen from the
air as it is pushed through the sieve beds. This allows the
oxygen enriched product gas to pass through before
being delivered to the pressure regulator. As one tube is
generating the product gas, the other is being purged of
the adsorbed nitrogen, this process is called pressure
swing adsorption (PSA). After passing through the
regulator, the rate of product gas being delivered to the
patient is set by the flow meter adjusting valve. Finally,
it passes through a fine particle filter and then over a
sensor that detects the oxygen concentration of the
product gas before it exits the device through a fire
resistant outlet. The product gas is delivered to the
patient and absorbed by tissues within the nose, lungs
and the pathway between the two.
2.2 Device Features
Front panel (Fig. 1)
1 - Power Switch
2 - Humidifier
(space reserved)
3 - Oxygen product outlet
4 - Flow adjustment knob
(LPM)
5 - Circuit Breaker
6 - Indicator Lights
(yellow and green)
Rear panel (Fig. 2)
7 - Cabinet Air Filter
8 - Manufacturer's
Technical Label
9 – Mains Cable
Rear panel (Fig. 3)
10 – Hour meter
11 - Filter / Silencer
12 - Ventilation Grille

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2010-2324CE-G March 2022 Page 3 of 8
EN
Use the power cord provided.
Check that the electrical characteristics of the power
outlet used match those indicated on the manufacturer’s
plate on the rear panel of the device.
This unit may be equipped with a polarized plug. That is
one blade wider than the other. If it does not fit into the
outlet, reverse the plug. If it still does not fit, contact a
qualified electrician. Do not defeat this safety feature.
2.3 Alarms and Safety Features
The device has an audible alarm to warn 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.
No voltage detection: In the event of a loss of mains
power, an intermittent audible alarm is activated and the
green light turns off.

Test alarm by actuating the Power Switch (Fig 1-1) when
the mains cable is not plugged into the power outlet.
Oxygen Concentration Status Indicator: The oxygen
concentration monitor is an electronic module capable of
checking the effective oxygen concentration supplied by
the concentrator. The oxygen monitor measures the
concentration and activates an audible and visual alarm if
it falls below the alarm set point percentage. When the
device is started, the indicator lights (Fig 2-6) located on
the front panel operate as described below.
Green indicator: This light indicates that power is
applied to the concentrator and that it is ready to provide
oxygen enriched air to the patient.

On initial power up, this indicator light will flash green
until the device has reached normal operating conditions.
This should happen within approximately 2 minutes.
Yellow indicator: This light and a continuous audible
alarm will activate when the oxygen concentration level
falls below the set point.
Devices manufactured prior to 2018 included a red indicator light.

No special maintenance is required. The alarm set-point is
factory set and the setting cannot be adjusted.
All OCSI models are set at 85% ± 3%.
Blocked Cannula detection: If supplied, 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 1-1) to the “O” (OFF) position.
Call your equipment supplier to service the device.
Thermal safety: The compressor motor is protected by a
thermal switch situated in the stator winding (145 ± 5° C).
One tubeaxial fan cools the compressor compartment and
additional fans cool the heat exchanger coil for the Nuvo
8 and Nuvo 10 models (585, 985, 595, and 1005).
Electrical protection:
 A 5A circuit breaker is incorporated into the front
cabinet of all 230V models
 A 10A circuit breaker is incorporated into the front
cabinet of all 115V models
 Class II devices with insulated casings (EN60601-1 standard)
Safety valve: This is fitted on the compressor outlet and
is calibrated to 3.4 bar (50 psig).
Fire Break: This device is fitted with a metal fire break
at the Oxygen Product Outlet (Fig 1-3). This break will
keep fire from entering the device. See “Accessories and
Spare Parts” (§ 2.5) for fire safe accessories.
2.4 Device 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 505/565 905/965 585 985 595 1005
Description 5lpm
115V
5LPM
230V
8LPM
115V
8LPM
230V
10LPM
115V
10LPM
230V
Frequency 60Hz 50/60Hz 60Hz 50/60Hz 60Hz 50Hz
Average
Power
410
Watts
420
Watts
500
Watts
490
Watts
700
Watts
600
Watts
Protection
Class Class II
Mains
Protection 10A 5A 10A 5A 10A 5A
Average
Oxygen
Content
At 2 LPM
> 90%
At 2 LPM
> 90%
At 2 LPM
> 90%
Average
Oxygen
Content
At 5 LPM
87% to 95.5%
At 8 LPM
87% to 95.5%
At 10 LPM
87% to 95.5%
Liter Flow 1 to 5 LPM 2 to 8 LPM 2 to 10 LPM
Outlet
Pressure 7 Psig 15 Psig 20 Psig
Dimensions
(L x W x H) 394 x 396 x 706 mm (15.5 x 15.6 x 27.8 in.)
Weight 24.5-26 kg (54-58 lbs)*
Noise Level < 58 dBA
* Weight dependent on model and features

In compliance with EN ISO 80601-2-69, the flow supplied is
equal to the flow set on the flowmeter, accurate to within
± 10% or 200 ml/min, whichever is greater.

The variation of the maximum recommended flow does not
exceed ± 10 % of the indicated value when a back pressure
of 6.9 kPa (1 psig) is applied to the output of the device.
Materials in direct or indirect contact with the patient
Concentrator enclosure ABS/Polycarbonate
Printed labels Polycarbonate
Power switch (Fig 1-1) Nylon
Oxygen product outlet (Fig 1-3) SS or Brass
Flow adjustment knob (Fig 1-4) ABS

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2010-2324CE-G March 2022 Page 4 of 8
Humidifier - Figure 4
Cannula - Figure 5
Cabinet air filter (Fig 2-7) Polyester
Mains cable (Fig 2-9) PVC
Filter / Silencer (Fig 3-11) Polypropylene
Humidifier Polypropylene
Casters Nylon
Pipe/Tubing Aluminum, PVC,
copper, polyurethane
and/or silicone
2.5 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 Quality System Regulation or the 93/42/EEC
European Directive, or any other applicable regulatory
requirements.
The accessories below, available from Nidek Medical
Products, Inc. and our distributors, comply with these
requirements. Contact your equipment supplier to obtain
these accessories.
Accessories Part Ref
Humidifier (1 to 5 LPM) 9012-8774
High Flow Humidifier (2 to 10 LPM) 9251-8774
Cannula with 2m (7ft) tubing (1 to 5 LPM) 9012-8780
High Flow Cannula with 2m (7ft) tubing
(2 to 10 LPM)
9251-8780
Extension Tubing 7.7m (25 ft) 9012-8781
Tubing Adapter 9012-8783
Adapter, DISS to hose 9012-8785
Fire Safe Valve 9800-8779
Fire Safe Nozzle 9800-8777
Petroleum and oil based lubricants, lotions and cosmetics
are flammable and the use of them while operating the
device is hazardous.
Improper patient connection to an
d us
e 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 15.5m (50 ft) in length
of tubing.
Ears, nose and neck may become irritated after prolonged
exposure to the cannula. For relief, only a water based
lubricant is recommended.
Nasal passages may become irritated after prolonged
exposure to the product gas. If this occurs, consult your
physician about using a humidifier during treatment.
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.
Spare Parts Part Ref
Cabinet air filter (Fig 2-7) 9250-1025
Filter / Silencer (Fig 3-11) 9250-1180
Ventilation Grille (Fig 3-12) 9250-1006
Casters 8300-8068
Mains Cable Wrap 8400-0022
Please consult the Nuvo Family Service Manual (PN 2010-
2329) for instructions on replacing any above spare parts.
3 UNPACKING AND INSPECTION
The Oxygen Concentrator is packaged to protect the
device from damage while being transported and stored.
After the device is removed from the package, inspect
for damage. If damage is detected, please contact your
equipment provider.
If you do not plan to use your device immediately, please
consult the Environmental Storage Conditions below.
Environmental Storage Conditions:
The device should be stored in a dry area, with an
ambient temperature between -20°C to 60°C (0°F to
140°F) at 15-95% relative humidity. It must be stored,
transported and used in the vertical position only.
Oxygen concentration can be affected after prolonged
periods of storage – check device before use.
4 INSTALLATION AND OPERATION
4.1 Installation
Environmental Operating Conditions:
The device should be operated in a dry area, with an
ambient temperature between 10°C to 40°C (50°F to
105°F) at 15-95% relative humidity. The device can be
operated at an altitude of up to 1500m (5000ft) at a
temperature of 21°C (70°F) without causing product
degradation.
DO NOT use in explosive atmosphere.
To avoid risk of fire and explosion the concentrator should
be kept away from heat sources, incandescent sources,
solvents, Aerosols, etc.
Unit should be placed and operated in a well-ventilated
space that is free of pollutants or fumes and protected
from the elements with adequate lighting.
Unit should be placed and operated in a space where the
position and storage of the mains cable (Fig 2-9) and
oxygen tubing do not present a tripping hazard. The
mains cable should be easily accessible for disconnection.
For patient safety and benefit, no modification to the
equipment is allowed. It is also not recommended to
interconnect the device with any equipment or
accessories not specified in this guide.

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2010-2324CE-G March 2022 Page 5 of 8
EN
Device must have power to operate. In the event of power
loss and for continued operation a backup source is
recommended.
Do not use in a specifically magnetic environment (MRI, X-
ray, etc.). May cause device malfunction.
We recommend against the use of extension cords and
adapters, as they are potential sources of sparks and fire.

Consult your equipment provider for further information
regarding altitudes of 1500 m to 4000m (5000 to 13000ft).

Complies with
EN 60529:2001 + A2:2014 rating of
IPX1
;
enclosure protects internal electrical components against
vertically falling water drops.
Complies with EN 60601-1:2006 [11.6.3]; enclosure
protects internal electrical components against spilling of a
glass of water (i.e. contents of humidifier).
4.2 Start-Up
1) Ensure that the Power Switch (Fig 1-1) is in the “O”
(OFF) position.
If used with a humidifier (Fig 4): Unscrew the flask
and fill it with distilled water up to the line (see
manufacturer’s instructions). Then screw the lid on
the humidifier flask until there are no leaks. Connect
the oxygen tube to the humidifier outlet nozzle.
Screw the humidifier directly to the Oxygen Product
Outlet (Fig 1-3). Ensure that all of the parts are
connected correctly so as to avoid leaks.

Replace water in humidifier bottle before each
treatment.
If not using a humidifier: Attach a DISS to hose
Adapter (PN 9012-8785) to the Oxygen Product
Outlet (Fig 1-3). Connect the oxygen tube to the
adapter.
2) Plug the power cable into a power outlet of the
correct voltage and frequency as defined on the
manufacturer’s technical label (Fig 2-8).
3) Press the Power Switch (Fig 1-1) to the ON “I”
position.

See the Alarms and Safety Features on page 3 for
indicator lights and meanings.
4) Turn the flow adjustment knob (Fig 1-4) to the
prescribed value.

View the flowmeter from straight on for accurate
settings.

The required oxygen concentration is normally
obtained within two minutes after the device is
started.
5) Check that the oxygen flows out of the administration
device (nasal cannulas 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
1-1) 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
operati
on a
nd after shut down
that
the cannula is facing away from soft surfaces and
clothing. Excess oxygen can accumulate and cause
ignition if exposed to a spark or open flame.

After turning the unit off, the user must wait 3-5
minutes before turning it back on. System pressure must
dissipate before the unit will properly restart.
5 CLEANING AND MAINTENANCE
5.1 Cleaning
Cleaning your device: Visually check the outside of the
device periodically. To clean the enclosure, make sure
the Mains Switch (Fig 1-1) is in the "O" (OFF) position,
then use a soft, dry cloth or a damp sponge, to wipe the
cabinet enclosure until clean and to prevent dust and dirt
from building up on the device. Allow to dry thoroughly
before operation.

Acetone, solvents or any other flammable products must
not be used. Do not use abrasive powders.
Cleaning and replacing filters: The removable cabinet
air filter (Fig 2-7) must be cleaned in warm water and
household detergent. Dry before reinstalling. The inlet /
silencer filter (Fig 3-11) should be inspected at each
patient visit and replaced if required. The final product
filter (not pictured) should only be replaced by a
technician if required (not common).
Cleaning and replacing accessories: Clean the
humidifier according to manufacturer’s instructions. If
no instructions are provided, do the following: empty the
water from the humidifier, rinse the flask and lid under
running water. Regularly disinfect the humidifier by
immersing the flask and lid in a disinfectant solution (we
recommend using a solution of 1 part vinegar to 10 parts
water). Rinse under running water and dry. Tubing and
cannula should be used according to the manufacturer’s
instructions and replaced for each new patient to prevent
the spreading of bacteria and viruses.
5.2 Maintenance
No special maintenance needs to be carried out by the
patient. Your equipment supplier performs periodic
maintenance operations to assure continued reliable
service from the device.
DO NOT disassemble due to danger of electrical shock.
Refer servicing to qualified service personnel.
The expected service life of this device is 10 years with
routine preventive maintenance.

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2010-2324CE-G March 2022 Page 6 of 8
Preventive Maintenance: Wash cabinet filter (see
“Cleaning and replacing filters”) weekly or after
approximately 100 hours of use and for each new patient.
More frequent cleaning is recommended in dusty
environments. Inspect inlet air filter (Fig 3-11) at each
patient visit. Replace filter annually, or more often
depending on environment. Check oxygen concentration
every 15,000 hours or 3 years to verify the continuing
OCSI function.
The manufacturer’s instructions for the preventive
maintenance of the devices are defined in the service
manual, (Ref. 2010-2329). Check with your service
provider for any updates to recommended schedules. The
work must be carried out by suitably trained technicians
certified by the manufacturer. Use original spare parts
only (see “Accessories and Spare Parts”). Upon request,
the supplier can provide circuit diagrams, spare parts
lists, technical details or any other information of use to
qualified technical personnel for parts of the device
which are designated as being the manufacturer’s
responsibility or by the manufacturer as repairable.
6 DISPOSAL
6.1 Method for Waste Disposal
All waste from the device (Patient Circuit, Molecular
Sieve, Filters, Etc.) must be disposed of using methods
appropriate to the civil authority of the location where
disposed.
6.2 Disposing of the Device
This device has been supplied by an environmentally
aware manufacturer. A majority of the parts in the device
are recyclable.
Follow local governing ordinances and recycling plans
regarding disposal of the device or components normally
used in operation. Any accessories not original to the
device must be disposed of in accordance with the
individual 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 2-9) is not correctly
plugged into the wall outlet.
Check the cable connection.
The no voltage detection alarm test does not work.
(See Alarms and Safety Features)
Capacitor is not charged Internal
electrical fault.
Check the circuit breaker (Fig 1-5) on the front
of the unit; Reset if necessary.
Plug unit in for 10 minutes and retest.
Contact your equipment supplier.
The I-O (ON/OFF) button is in the “I”
(ON) position, the
compressor is operating and there is a flow but the
green light is not lighted.
Faulty indicator. Contact your equipment supplier.
The I-O (ON/OFF) button is in the “I” (ON) position but
there is no flow. The audible alarm sounds
continuously.
Pneumatic connection broken or
other pressure problem.
Stop the device by pressing the I-O (ON/OFF)
button and contact your equipment supplier.
The I-O (ON/OFF) button is in the “I”
(ON) position, the
compressor is operating and there is a flow but the
audible alarm sounds continuously.
Internal electrical fault.
Pneumatic circuit fault or low purity.
Stop the device by pressing the I-O (ON/OFF)
button and contact your equipment supplier.
The compressor stops in mid-cycle, then starts again
after a few minutes.
Compressor thermal safety device
has been activated.
Dirty Filters.
Cooling fan(s) not operating.
Stop the device and wait for it to cool down.
Clean cabinet filter. Restart. If the device does
not start, contact your equipment supplier.
Stop the device by pressing the I-O (ON/OFF)
button and contact your equipment supplier.
The oxygen enriched air flow is interrupted at the
nasal cannula outlet.
Tube disconnected or humidifier cap
is not tight.
Check that tubing connections are secure and
that the humidifier is sealed.
The flow at the nasal cannula outlet is irregular. Cannula tubing is kinked or
restricted.
Straighten the tubing; contact your equipment
supplier if damaged.

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2010-2324CE-G March 2022 Page 7 of 8
EN
be powered from an uninterruptable power supply (UPS).
8 EMC INFORMATION

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2010-2324CE-G March 2022 Page 8 of 8
9 CONFORMITY WITH EN 60601-1
CONFORMITY WITH EN 60601-1 (§ 6.8.2 b):
The manufacturer, assembler, installer or distributor are not considered to be responsible themselves for the
consequences on the safety, reliability and characteristics of a device unless the:
 Assembly, fitting, extensions, adjustments, modifications or repairs have been performed by persons authorized by
the party in question.
 Electrical installation of the corresponding premises complies with local electrical codes. (e.g. IEC/NEC)
 Device is used in accordance with the instructions for use.
If the replacement parts used for the periodic 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
electrosurgical equipment, mobile telephones, 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.
EU Representative
mdi Europa GmbH
Langenhagener Str. 71
30855 Hannover-Langenhagen
Germany
Tel: [phone]
Fax: [phone]
[e-mail]
www.mdi-europa.com
Nidek Medical Products, Inc.
3949 Valley East Industrial Drive
Birmingham, Alabama 35217 U.S.A.
Tel: [phone] Fax: [phone]
UK Responsible Person
Qserve Group UK, Ltd
49 Greek Street
W1D 4EG London
United Kingdom
Tel: [phone]
[e-mail]
www.qservegroup.com