Nidek medical Mark 5 nuvo series User manual

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2010-2324CE-G March 2022 Page 1 of 8

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

(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

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

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

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