Nidek medical Nuvo series User manual

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2010-2324CE-B September 2015 Page 1 of 12

USER'S GUIDE

Mark 5 Nuvo Family

NUVO, NUVO 8 & NUVO 10

OXYGEN CONCENTRATOR

[Original language is English]

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.

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CONTENTS GLOSSARY OF SYMBOLS

ARNING

GLOSSARY OF SYMBOLS 1

1.GENERAL SAFETY GUIDELINES 2

1.1. Method for aste Disposal 3

1.2. Method for Disposing of Device 3

2. Des ription 3

2.1. Front panel (Fig. 2. 1) 3

2.2. Rear panel (Fig. 2. 2) 3

3. STARTING-UP / INSTALLATION 3

3.1. Use in direct oxygen therapy 3

4. CLEANING-MAINTENANCE 4

4.1.Cleaning 4

4.2.Everyday disinfection 4

4.3.Maintenance 4

5.USEFUL INFORMATION 4

5.1.Accessories and spare parts 4

5.2.Materials in direct/indirect contact

with patient 5

5.3.Operating principles 5

5.4.Alarms - Safety devices 5

5.5.Indicators 5

5.6.Expected Life 6

5.7.Technical characteristics 6

5.8.Standards 7

5.9.Preventative Maintenance 7

5.10 Troubleshooting 8

6. EMC, Ele tromagneti statements 9

: ON (Power Switched on)

: OFF (Power Switched off)

: Type B Device

: Class II Protection

: DO NOT EXPOSE TO OPEN FIRE

: DO NOT USE OIL OR GREASE

: Technical Information

: Consult the accompanying documents

: Keep in vertical position

: Fragile - Handle with care

: Oxygen concentration warning light

0413 Complies with the 93/42/EEC directive

certified by the approved organization 0413.

DANGER: Do not smoke when using

oxygen or when near this devi e.

NUVO 8

hown for reference

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2010-2324CE-B September 2015 Page 2 of 12

GENERAL SAFETY GUIDELINES

Only persons who have read and understood this entire manual should be allowed to operate the device.

The WARNINGS below indi ate a potentially hazardous situation. If onditions are not avoided a situation

ould o ur that results in serious injury or death.

• Oxygen is not a flammable gas, but it accelerates the combustion of materials. Do not use in explosive

atmosphere. To avoid risk of fire and explosion the concentrator should be kept away from Flames, Heat

sources, Incandescent sources, Smoking Materials, Matches, Oil, Grease, Solvents, Aerosols, etc. Do not allow

oxygen to accumulate on upholstery or other fabric such as bedding or personal clothing. If concentrator is

operating while not connected to patient, position cannula so that the gas flow is diluted in the ambient air.

• Improper patient connection to and use of the cannula may result in injury including strangulation. Avoid

situations that might cause the cannula or hose to become entangled about the patients neck.

• Use of other accessories not described in this User's Guide are not recommended. Patient benefit may be

diminished.

• No modification to the equipment is allowed. To do so may affect patient benefit.

• 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).

• Device must have power to operate. In the event of power loss and for continued operation a backup source is

recommended.

• DO NOT disassemble due to danger of electrical shock. Refer servicing to qualified service personnel.

The CAUTIONS below indi ate a potentially hazardous situation. If onditions are not avoided a situation ould

o ur that results in property damage or minor injury or both.

• Use the power cord provided, and check that the electrical characteristics of the power socket used match those

indicated on the manufacturer’s plate on the rear panel of the device.

• e recommend against the use of extension cords and adapters, as they are potential sources of sparks and fire.

• 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.

• The device must only be used for oxygen therapy and only on a medical prescription. The indicated daily

duration and flow must be followed, otherwise it may present a risk to the health of the patient.

• Do not use in a specifically magnetic environment (MRI, X-ray, etc.). May cause device malfunction.

• 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.

• Note: Medical Device Regulations require users and service providers to report to the manufacturer any incident

that could, if repeated, result in injury to any person.

CONFORMITY WITH IEC60601-1-2003

(2ND EDITION)

“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 near by, 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.

UNPACKING and PACKAGING

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.

Operating environmental condition guidelines are discussed later in another section of this User’s Guide.

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2010-2324CE-B September 2015 Page 3 of 12

1.1 METHOD FOR WASTE DISPOSAL

All waste from the device (Patient Circuit, Filters, Etc.) must be disposed of using methods appropriate to the civil authority

of the location where disposed.

1.2 METHOD FOR 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.

2. DESCRIPTION

The device is intended to supply supplemental oxygen to persons requiring oxygen therapy. It is not intended to be life

supporting or life sustaining. It produces an oxygen enriched product by concentrating the oxygen contained in room air. It

can be used to administer oxygen with nasal cannulas or another type of device.

The device is easy to use, it has a power failure alarm and an operating fault alarm. A single flow adjustment knob allows:

• the device to be easily adjusted to the prescribed flow rate,

• the equipment supplier or medical staff to limit flows to a specific flow rate with a built in locking device.

Note: the performances described pertain to the use of the device with accessories recommended by Nidek Medical

Products, Inc. Refer to section 5.

2.1. Front panel (Fig. 2.1)

• 1 - (I/O) On/Off Power Swit h

• 2 - Humidifier (spa e reserved)

• 3 - Oxygen produ t outlet

• 4 - Flow adjustment knob (lpm)

• 5 - Cir uit Breaker

• 6 - OCSI (Oxygen Con entration

Status Indi ator) Indi ator Lights

2.2. Rear panel (Fig. 2.2)

• 7 - Cabinet Air Filter

• 8 - Manufa turer's Te hni al Label

• 9 - Power Cord

3. STARTING UP / INSTALLATION

3.1. Use in dire t oxygen therapy

a. Ensure that the switch I/O is in the "O" (OFF) position.

b. If used with a humidifier:

• Unscrew the flask and fill it with water up to the line (see humidifier instructions). Then screw

the lid on the humidifier flask until there are no leaks.

• Connect the oxygen tube to the humidifier outlet nozzle or to the concentrator outlet if a

humidifier has not been prescribed. The tube between the cannula and the device should be

limited to 20 meters (60 feet) long, in order to ensure that the oxygen flow rate remains

within specification values.

• Ensure that all of the parts are connected correctly so as to avoid leaks

c. Plug the power cable into a power outlet of the correct voltage and frequency as defined on the

manufacturer's technical label (8).

d. Press the power switch ( I / O ) to the ON position ( I ). The green indicator will light when the oxygen

concentration exceeds the set point (OCSI) or normal operating pressures.

Note: 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.

Figure 2.1

Figure 2.2

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2010-2324CE-B September 2015 Page 4 of 12

e. Turn the flow adjustment knob (4) to the prescribed value. This knob may have already been locked in the medically

prescribed position. In this case, do not force it. Only the technician or medical personnel are authorized to release it.

Note: View the flowmeter from straight on for accurate settings.

f. 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.

g. Adjust the nasal cannula to suit your face.

Note: the required oxygen concentration is normally obtained within five minutes after the unit is started.

h. At the end of the treatment, press the I/O Switch to place it in the O (OFF) position to stop the device. The

oxygen enriched air flow continues for approximately one minute after the device is stopped.

Note: For the equipment supplier or medi al staff: The flow adjustment knob may be locked to limit it to a specific

predetermined value.

4. CLEANING - MAINTENANCE

4.1. Cleaning

Only the outside of the device is to be cleaned, with a soft, dry cloth or, if necessary, a damp

sponge, then thoroughly dried with wipes and an alcohol based solution. Acetone, solvents or

any other inflammable products must not be used. Do not use abrasive powders.

The removable cabinet air filter (7) must be cleaned in warm water and household

detergent weekly or after approximately 100 hours of use. More frequent cleaning is

recommended in dusty environments. Dry before reinstalling.

4.2. Daily disinfe tion

Because there is a final product filter inside the device, daily disinfection concerns only the

external oxygen therapy accessories: humidifier, nasal cannulas (refer to the respective

instructions for use).

The devi e must be swit hed off when al ohol based solutions are used.

a. The following minimum guidelines must be observed:

Humidifier: (If prescribed by a physician)

Clean according to the manufacturer's instructions. If no instructions are provided, do the following:

Daily:

• Empty the water from the humidifier.

• Rinse the humidifier flask under running water.

• Fill humidifier up to the mark with distilled water.

Regularly:

• Disinfect the humidifier parts by immersing them in a disinfectant solution (In general, we recommend using a

solution of 1 part vinegar diluted with 10 parts water).

• Rinse and dry.

• Check that the humidifier lid seal is in good condition.

Oxygen tubing and nasal cannula: Follow the manufacturer’s instructions.

b. For ea h new patient:

Follow the instructions from the humidifier manufacturer. The device must be cleaned and disinfected as per the above

instructions. The cabinet air filter (7) should be washed or replaced. The entire oxygen administration circuit (oxygen

therapy nasal cannulas, etc.) must be changed.

4.3. Maintenan e

No spe ial maintenan e needs to be arried out by the patient. Your equipment supplier performs periodic maintenance

operations to assure continued reliable service from the device.

5. USEFUL INFORMATION

5.1. A essories and spare parts

The accessories used with the device must:

• be oxygen compatible,

• be biocompatible,

• comply with the general requirements of the FDA Quality System Regulation or the 93/42/EEC European

Directive as appropriate.

The connectors, tubes, nasal cannulas, or masks must be designed for oxygen therapy usage.

Figure 2.3

10 - Hourmeter

11 - Filter / Silen er

Ventilation Grille

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2010-2324CE-B September 2015 Page 5 of 12

The accessories with a Nidek Medi al part number reference, or included in the set of accessories supplied with the device,

comply with these requirements. Contact your equipment supplier to obtain these accessories.

Note: The use of certain administration accessories which are not specified for use with this concentrator may reduce its

performance and void the manufacturer’s responsibility (ISO 8359).

AVAILABLE ACCESSORIES IF PRESCRIBED BYA PHYSICIAN

• Humidifier: Part Ref. 9012-8774 (1-5LPM) Part Ref. 9251-8774 (2-10LPM)

• Cannula with 2 m (7 ft) tubing: Part Ref. 9012-8780 (1-5LPM) Part Ref. 9251-8780 (2-10LPM)

• Extension Tubing 7.7 m (25ft): Part Ref. 9012-8781

• Tubing Adapter: Part Ref. 9012-8783

The items listed above are available from Nidek Medical Products, Inc.

5.2. Materials in dire t or indire t onta t with the patient

• Concentrator enclosure ABS/Polycarbonate

• Mains cable PVC

• Cabinet air filter Polyester

• I/O (On/Off) switch Nylon

• Casters Nylon

• Flow adjustment knob ABS

• Oxygen product outlet SS or Brass

• Printed labels Polycarbonate

• Pipe/Tubing Aluminum, PVC, polyurethane and/or silicone

• Humidifier Polypropylene

• Filter Polypropylene

5.3. Operating prin iple

The compressor sends filtered ambient air to an electronic valving system, which allows compressed air to pass to the

column in production. The columns contain a molecular sieve, whose function is to adsorb the nitrogen and thus allow

oxygen to pass. The oxygen enriched product is then directed to a pressure reducing valve through the adjustable flow

meter to the oxygen outlet fitting. During this time, the column which is being "regenerated" is connected to the ambient air

and flow of oxygen enriched product is passed through it (from the column "in production"). In this way, when one column

is in production, the other is in a nitrogen desorption or "regeneration" phase. The oxygen enriched product finally passes

through a bacterial filter located prior to the oxygen outlet fitting.

5.4. Alarms - Safety devi es

5.4.1. Alarms

• No voltage dete tion: In the event of a loss of mains power, a intermittent audible alarm is activated and the

green light turns off. Test alarm by actuating the I/O (On/Off) switch when the power cord is not plugged into the

wall receptacle.

• Oxygen on entration: The oxygen monitor measures the concentration and activates an audible and visual

alarm if it falls below the alarm set point percentage.

• Blo ked annula: If supplied, the device Oxygen Concentrator has a No Flow Alarm. This device provides an

continuous audible alarm and red light in the event the Oxygen Flow to patient becomes blocked.

• Maintenan e of the devi e alarms: No special maintenance is required. The alarm set-point is factory set and the

setting cannot be adjusted. All OCSI models are set at 84% ± 2%. The equipment supplier checks that the device is

still operating correctly when the routine checks are performed on the device.

5.4.2. Safety devi es

Compressor motor:

• Thermal safety is ensured by a thermal switch situated in the stator winding (145 ± 5° C).

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2010-2324CE-B September 2015 Page 6 of 12

Ele tri al prote tion of the device:

• 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 castings (EN60601-1 standard)

Safety valve:

• This is fitted on the compressor outlet and is calibrated to 3.4 bar (50 psig).

5.5 INDICATORS

Oxygen Con entration Status Monitor

The oxygen concentration monitor (6) 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. hen the device is started, the indicator lights located on the front panel

operate as described below.

5.5.1. Green indi ator

The green indicator light indicates that power is applied to the concentrator and that it is ready to provide oxygen

enriched air to the patient. To be lighted, it is necessary that the concentrator power plug be inserted into the wall

outlet, that the I/O (On/Off) switch be actuated and that the oxygen concentration has reached the alarm set-point. On

initial power up it will flash green until the unit has reached normal operating conditions.

5.5.2. Red indi ator

The red indicator light is used to warn the patient of a system fault. The two events that can cause the red indicator to

be lighted are low oxygen concentration or blockage of the cannula or hose (if equipped). The low oxygen

concentration warning will light when the oxygen concentration level falls below the set point. hen the red indicator

light is lighted for 15 minutes (±2 minutes), a continuous audible alarm is activated. Call the equipment supplier to

service the device.

5.6. Expe ted Servi e Life

• The expected service life of this device is 15,000 hrs or 3 years.

5.7. Te hni al hara teristi s

Physi al Properties

• Dimensions: L x x H: 394 x 396 x 706 mm (15.5 x 15.6x 27.8 in.)

• Caster diameter: 50 mm (2.0 in.)

• Tilt angle (transport with humidifier fitted): 70°

• eight: 24 kg /54 lbs

• Noise level within ISO 8359 guidelines

Flow values:

• Continuously Adjustable Flowmeter: 1 to 5 lpm, 2 to 8 lpm, or 2 to 10 lpm (depending on model)

A ura y of flow supplied:

• In compliance with the ISO 8359 standard, the flow supplied is equal to the flow set on the flowmeter, accurate to

within ± 10% or 200 ml/min, whichever is the larger of the two.

Average oxygen ontent:

• 2 lpm: > 90% (Values at 21°C and at one atmosphere pressure)

• 5 lpm, 8 lpm, 10 lpm: from 87% to 95.5% (Values at 21°C and at one atmosphere pressure)

• Minimum recommended flow: 1 lpm on Nuvo unit, 2 lpm on Nuvo 8 & 10 units

• Maximum recommended flow: 5 lpm on Nuvo, 8 lpm on Nuvo 8 and 10 lpm on Nuvo 10 model specific

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. The maximum outlet pressure is: 7psig for Nuvo

5 lpm, 15 psig for Nuvo 8 lpm, and 17 psig for Nuvo 10 lpm.

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2010-2324CE-B September 2015 Page 7 of 12

Ele tri al power supply:

Model 5lpm 115V 5LPM 230V 8LPM 115V 8LPM 230V 10LPM 115V 10LPM 230V

Frequency 60Hz 50/60Hz 60Hz 50Hz 60Hz 50Hz

Avera e

Power

410 Watts 420 Watts 500 Watts 490 Watts 700 Watts 600 Watts

Protection

Class

Class II Class II Class II Class II Class II Class II

Mains

Protection

10A 5A 10A 5A 10A 5A

Filters:

• At the rear of the device: a cabinet air filter (7).

• At the compressor input: an inlet air filter (11), behind cabinet air filter.

• Before the oxygen outlet: a final product filter < 0.3 µm. (technician only)

Air ir ulation:

• One tubeaxial fan cools the compressor compartment and additional fans cool the heat exchanger coil on 8 & 10

lpm models.

Environmental limit onditions:

The performance of the device (especially the oxygen concentration) are quoted at 21°C (70°F) and one atmosphere.

They may change with temperature and altitude. For further information, please consult the service manual. See Section

5.9.

• The device must be stored, transported and used in the vertical position only.

• Ambient temperature of between 10°C and 40°C (50ºF to 105°F) operation.

• Storage temperature from -20°C to 60°C (0°F to 140°F).

• Relative humidity of between 15 % and 95 % operation and storage, both non-condensing.

• Altitude(21°C): Up to 1500m (5000ft) without degradation;

Consult your equipment provider for further information regarding 1500 m to 4000m (5000 to 13000ft).

Complies with EN60601-1:2003 standard; spilling of a glass of water.

5. 8. Standards - Nuvo, Nuvo 8 & Nuvo 10

ISO 8359:1996 Oxygen concentrators for medical use.

EN60601-1[UL60601-1:2003]

CAN/CSA-C22.2No.601.1-M90 w/A1&A2: Electrical Safety- Medical Devices.

EN60601-1-2:2001 Electromagnetic Compatibility

Nuvo Serial No. __________________________

Date first used: __________________________

Maintained by: __________________________

Your equipment provider address: ________________________

Telephone : ______________________

5.9. PREVENTIVE MAINTENANCE:

a. ash cabinet filter (7) weekly.

b. Inspect inlet air filter (11) at each patient visit. Replace filter annually, or more often depending on environment.

c. 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, part ref:

2010-2329 NUVO Family Service Manual. 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 section 5.8 Maintenance). 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.

Medical Device Regulations require users and service providers to report to the manufacturer any incident that could, if

repeated, result in injury to any person.

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2010-2324CE-B September 2015 Page 8 of 12

5. 10. Troubleshooting.

Observations Possible Causes Solutions

The I-O (ON/OFF) button is in the “I” (ON)

position but the device does not operate.

Power cable (9) is not correctly

plugged into the wall outlet.

Check the cable connection.

Capacitor is not charged Internal electrical fault. Capacitor is not charged Internal

electrical fault.

Check the circuit breaker (5) on the front

of the unit; Reset if necessary.

Capacitor is not charged Internal electrical fault. Capacitor is not charged Internal

electrical fault. Contact your equipment supplier.

The alarm test does not work. See IV 4.1. Capacitor is not charged Internal

electrical fault.

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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