Nidek medical Lite User manual

May 20112010-8401CE Rev C 1

USER'S GUIDE

Mark 5 Nuvo(OCSI)

LITE

OXYGEN CONCENTRATOR

FederalLaw (US) restricts this deviceto sale

or use by, or on the order of, a licensed phy-

sician. This oxygen concentrator should be

used only under the supervision of a licensed

physician.

0413 Complies with the 93/42/EEC directive

certi ed by the approved organization no 0413.

CONTENTS

: ON (power switched on)

: Off (power switched off)

: Type B device

: Class II protection

: Do not expose to open  ames

: Do not use oil or grease

: Technical information

: Consult the accompanying documents

: Keep in the vertical position

: Fragile - handle with care

: Oxygen concentration warning light

GLOSSARY OF SYMBOLS

[Original language is English]

GLOSSARY OF SYMBOLS..........................................1

GENERALSAFETY GUIDELINES............................2

I. DESCRIPTION.......................................................2

I.1. F

ront panel (Fig. I. 1)......................................... 3

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

II. STARTING-UP / INSTALLATION ......................3

II.1. Use in direct oxygen therapy....................................3

III. CLEANING-MAINTENANCE.............................4

III.1. Cleaning...................................................................4

III.2.

Everyday disinfection...................................................4

III.3. Maintenance.............................................................4

IV. USEFULINFORMATION...................................4

IV.1. Accessories and spare parts.....................................4

IV.2. Materials in direct or indirect contact with

patient .....................................................................4

IV.3. Operating principles................................................4

IV.4. Alarms - Safety devices...........................................5

IV.5. Indicator light function ..........................................5

IV.6. Technical characteristics..........................................5

IV.7. Standards.................................................................6

IV.8. Method for disposing of waste................................6

IV.9. Method for disposing of device...............................6

IV.10.Troubleshooting........................................................7

APPENDIXA: EMC INFORMATION.......................8,9

Danger: Do not smoke when using oxygen or when

near this device

.

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USE OF OXYGEN

Oxygen is not a  ammable gas, but it accelerates the

combustion of materials. To avoid all risks of  re,

the MARK 5Nuvo LITE should be kept away from

all  ames, incandescent sources and sources of heat

(cigarettes), as well as any combustible products

such as oil, grease, solvents, aerosols, etc.

Do not use in an explosive atmosphere.

Avoid letting oxygen accumulate on an upholstered

seat or other fabrics. If the concentrator is operating

while not supplying oxygen to a patient, position it

so that the gas  ow is diluted in the ambient air.

Place the device in a ventilated area free from

smoke and atmospheric pollution (rear filter

unobstructed).

The MARK 5 Nuvo LITE must only be used for

oxygen therapy and only on a medical prescription.

The indicated daily duration and  ow must be

followed, otherwise it may present a risk to the

health of the patient.

Do not use in a speci cally magnetic environment

such as: (MRI, X-ray, etc.)

USEAND MAINTENANCE OFTHE DEVICE

Do not open the device while in operation: risk of

electrical shock.

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 machine.

We recommend against the use of extension cords

or adapters, as they are potential sources of sparks

and  re.

The MARK 5 Nuvo LITE 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.

GENERAL SAFETY GUIDELINES

Only persons who have read and understood this entire manual

should be allowed to operate the MARK 5 Nuvo LITE.

CONFORMITY WITH IEC60601-1 (§ 6.8.2 B):

"The manufacturer, assembler, installer or distributor are not

consideredtoberesponsiblethemselvesfortheconsequenceson

the safety, reliability and characteristics of a device unless:

• The assembly,  tting, extensions, adjustments, modi cations

or repairs have been performed by persons authorized by the

party in question,

• Theelectricalinstallationofthecorrespondingpremises

complies with local electrical codes. (e.g. IEC / NEC).

• The 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

speci cations, the manufacturer is not responsible in the event

of an accident.

ThisdevicecomplieswiththerequirementsoftheFDAQuality

System Regulation and 93/42/EECEuropean directive but its

operation may be affected by other devices being used near

by, such as diathermy and high frequency electro-surgical

equipment, de brillators, short wave therapy equipment,

mobiletelephones,CBandotherportabledevices,microwave

ovens, induction plates or even remote control toys or any

other electromagnetic interferences which exceed the levels

speci ed by the EN 60601-1-2 standard.

I. DESCRIPTION

The MARK 5 Nuvo LITE is intended to supply supplemen-

tal oxygen to persons requiring low  ow oxygen therapy.

It is not intended to be life supporting or life sustaining. It

produces an oxygen enriched product by removing most of

the nitrogen contained in room air. It can be used either to

administer oxygen with nasal cannulas or another probe or

mask type of device.

The MARK 5 Nuvo LITE is easy to use.

The single  ow adjustment knob allows:

• the device to be easily adjusted to the prescribed  ow rate,

• the equipment supplier or medical staff to limit  ows to a

speci c  ow rate with a built-in locking device.

It has a power failure alarm and an operating fault alarm.

Note:theperformancesdescribedpertaintotheuseofthe

MARK 5 Nuvo LITE with the accessories recommended

by Nidek Medical Products, Inc.

May 20112010-8401CE Rev C 3

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5

I.1. Front panel (Fig. I.1)

1 - I/O (ON/OFF) Switch

2 - Indicator Lights

3 - Oxygen product outlet

4 - Flow adjustment knob (l/min.)

5 - Circuit Breaker

I.2. Rear panel (Fig. I.2)

6 - Humidi er

7 - Filter

8 - Power Cord

9 - Elapsed Time Meter

10 - Technical Label

11 - Humidi er Tube

12 - Humidi er Bottle Velcro Strap

13 - Power Cord Retainer

3

5

1

5

43

7

II. STARTING UP / INSTALLATION

II.1. Use in direct oxygen therapy

a. Ensure that the switch (1) is in the O(OFF) position.

b. If used with a humidi er:

Unscrew the  ask and  ll it with water up

to the line (see humidi er instructions).

Then screw the lid on the humidi er  ask

until there are no leaks.

c. Connect the oxygen tube to the humidi er outlet nozzle

or to the concentrator outlet if a humidi er has not been

prescribed. The tube between the cannula and the MARK 5

Nuvo LITE shouldbe limited to 20 meters (60 feet) long,

in order to ensure that the oxygen  ow rate remains within

speci cation values.

d. Ensure that all of the parts are connected correctly so as

to avoid leaks.

e.Plug the powercableintoapoweroutlet of

the correct voltage and frequency as de ned

on the manufacturer's technical label (Fig

I.2).

f. Press the power switch (I/O)to the ON position ( I ).

Thegreenindicatorwilllightwhentheoxygenconcentration

exceeds the set point.

g. Turn the  ow 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.

h. Check that the oxygen  ows out of the administration

device (nasal cannulas or other) by placing the ori ce(s) on

the surface of a glass of water. The  ow should disturb the

surface of the water.

i. Adjust the nasal cannula to suit your face.

Note:therequiredoxygenconcentrationisnormallyobtained

within  ve minutes after the unit is started.

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  ow continues for approximately one minute

after the device is stopped.

For the equipment supplier or medical staff:

The  ow adjustment knob may be locked to limit it to a

speci c predetermined value.

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III. CLEANING - MAINTENANCE

III.1. Cleaning

Only the outside of the MARK5NuvoLITEis to becleaned,

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 in ammable products must

not be used. Do not use abrasive powders.

The removable cabinet air  lter (2) must be cleaned in warm

waterandhouseholddetergentweeklyorafterapproximately

100 hours of use. More frequent cleaning is recommended in

dusty enviroments. Dry before reinstalling.

66

9

III.2. Daily disinfection

Because there is a  nal product  lter inside the device, daily

disinfection concerns only the external oxygen therapy

accessories: humidi er, probes, nasal cannulas (refer to the

respective instructions for use).

The device must be switched off when alcohol based so-

lutions are used.

a. The following minimum guidelines must be

observed:

• Humidi er : (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 humidi er.

• Rinse the humidi er  ask under running water.

• Fill humidi er up to the mark with distilled water.

Regularly:

• Disinfect the humidifer 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 humidi er lid seal is in good condition.

•Oxygen tubing and nasal cannula:

Follow the manufacturer’s instructions.

b. For each new patient:

Follow the instructions from the humidi er manufacturer.

The MARK 5 Nuvo LITE must be cleaned and disinfected

as per the above instructions. The cabinet air  lter should be

washed orreplaced.The entire oxygen administration circuit

(oxygen therapy nasal cannulas, etc.) must be changed.

III.3. Maintenance

No special maintenance needs to be carried out by the

patient. Your equipment supplier performs periodic main-

tenance operations to assure continued reliable service from

the MARK 5 Nuvo LITE.

IV. USEFULINFORMATION

IV.1.Accessories and spare parts

The accessories used with the MARK 5 Nuvo LITE 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, probes or masks

must be designed for oxygen therapy usage.

The accessories with a Nidek Medical part number

reference, or included in the set of accessories supplied with

the device, comply with these requirements.

Contact your dealer to obtain these accessories.

NOTE: The use of certain administration accessories

which are not speci ed for use with this concentrator may

reduce its performance and void the manufacturer’s

responsibility (ISO 8359).

AVAILABLEACCESSORIES

IF PRESCRIBED BYA PHYSICIAN

Humidi er: P/N 9012-8774

Cannula with 2 m (7 ft) tubing: P/N 9012-8780

Extension Tubing 7.7 m (25ft): P/N 9012-8781

Tubing Adapter: P/N 9012-8783

The items listed above are available from

Nidek Medical Products, Inc.

IV.2. Materials in direct or indirect contact with the

patient

Concentrator casing ..................................................... ABS

Mains cable ................................................................. PVC

Cabinet Air fFlter................................................. .Polyester

I/0 (On/Off) switch ....................................................Nylon

Casters........................................................................Nylon

Flow adjustment knob.................................................. ABS

Oxygen product outlet ..................................Stainless Steel

Printed labels.................................................Polycarbonate

Pipe/Tubing......Aluminium,PVC, polyurethane or silicone

Humidi er ....................................................Polypropylene

Humidi er tube..............................................................PVC

Filter .............................................................Polypropylene

H

Tuyau d'alimentation de NEBAL .....Silicone

1. Filter / Silencer

2. Cabinet  lter

3. Ventilation grill

78

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910

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May 20112010-8401CE Rev C 5

IV.3. Operating principle

The compressor sends  ltered room air to a solenoid valve,

whichallowscompressedairtopass tothecolumninproduc-

tion.The columns contain a molecularsieve, 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  ow valve to the

oxygen product outlet  tting.

During this time, the column which is being "regenerated"

is connected to the ambient air and  ow of oxygen enriched

productispassedthroughit(fromthecolumn"inproduction").

In this way, when one column is in production, the other is in

a nitrogen desorption or "regeneration" phase. The oxygen

enriched product  nally passes through a  nal product  lter

located prior to the oxygen outlet  tting.

IV. 5. OCSI (oxygen concentration status indication mo-

dule) function

IV. 5.1. Operating principle

The Oxygen Monitor (2) is an electronic module capable of

checking the effective oxygen concentration supplied by the

MARK 5 Nuvo LITE concentrator.

The Oxygen Monitor measures the concentration and activa-

tes an audible and visual alarm if it falls below the alarm set

point percentage. When the MARK 5 Nuvo LITE is started,

the indicator lights operate as follows:

IV. 5.2. Green indicator

Thegreen(LED)indicatorlightindicatesthatpowerisapplied

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

Dimensions: L x W x H: 36x23x58.5 cm (14 x 9 x 23 in.)

Caster diameter: 3.8 cm (1.5 in.).

Tilt angle (transport with humidi er  tted): 30o.

Weight: 15 kg. 33 lbs (depends on model)

Noise level 45 to < 40 dBA (depends on model)

Flow values:

12 position  ow valve 0.125-5 liters/minute.

(Some models may have other values.)

IV.5.4. Maintenance of the Device Alarms

• No special maintenance is required. The alarm set-point is

factorysetandthesettingcannotbeadjusted.Modelsoperating

at 50 Hz are set at 83% and 60 Hz models are set at 85%.

• The equipment supplier checks that the device is still

operating correctly when the routine checks are performed

on the MARK 5 Nuvo LITE.

IV.6. Technical characteristics

IV.4. Alarms - Safety devices

IV.4.1.Alarms

•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 I/O (On/Off) switch when the power cord is

not plugged into the wall outlet.

•Process fault:

In the case of a process fault, a visible and audible alarm is

activated (continuous red light or lighted alarm and audible

alarm, see p. 7).

•No oxygen  ow alarm (if supplied with the unit):

The Nuvo Lite concentrator has a no  ow alarm option.

This device provides a continuous audible alarm in the

event the oxygen  ow to the patient becomes blocked.

IV.4.2. Safety devices

•Compressor motor:

Thermal safety is ensured by a thermal switch situated in the

motor winding (145 ± 5 oC).

•Electrical protection: of the MARK 5 Nuvo LITE:

A 5A circuit breaker is incorporated into the front cabinet

of all 230V models. A 10 A circuit breaker is included with

115V models.

Class II devices with insulated castings (EN60601-1

standard)

•Safety valve:

This is  tted on the compressor outlet and is calibrated to

2.7 bar (40 psig).

IV.5.3. Red indicator

The red (LED) indicator light is used to warn the patient

of a system fault. The event that can cause the red (LED)

indicator tobe lighted is low oxygen concentration . The low

oxygen concentration red (LED) warning will light when the

oxygen concentration falls below a predetermined set point.

When the red (LED) warning light is on for 15 minutes (±2

minutes),a continuous audiblealarm is activated.An audible

alarm will sound intermittently on loss of mains power. Call

the equipment supplier to service the device.

2010-8401CE Rev C

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MARK 5 Nuvo LITE Serial No. ______________

Date  rst used: ___________________________

Maintained by: ___________________________

_________________________________________

Your distributor: _________________________

Address : ________________________________

_________________________________________

Telephone : ______________________________

PREVENTIVE MAINTENANCE:

a. Wash cabinet  lter weekly.

b. Inspect inlet air  lter at each patient visit.

Replace  lter every 2 years, 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 de ned in the

maintenance manual. Check with your service

provider for any updates to recommended schedules.

The work must be carried out by suitably trained

technicians certi ed by the manufacturer.

Use original spare parts only (see Pg. 7).

Uponrequest,thesuppliercanprovidecircuitdiagrams,

sparepartslists,technicaldetailsoranyotherinformation

of use to quali ed technical personnel for parts of the

devicewhicharedesignatedasbeingthemanufacturer’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.

IV.8. Method for disposing of waste

AllwastefromtheMARK5NuvoLITE (patient circuit,  lter,

etc.) must be disposed of using the methods appropriate to

the civil authority of the location where disposed.

IV.9. Method for disposing of the device

In order to preserve the environment, the concentrator must

only be disposed of using the appropriate methods. All ma-

terials of construction are recycleable.

Furthermore, as part of the marking (directive 93/42/EEC),

the serial number of the device disposed of must be sent to

the Nidek Medical technical service department if the unit

has the marking.

Accuracy of  ow supplied:

In compliance with the ISO 8359 standard, the  ow supplied

is equal to the  ow set on the  owvalve, accurate to within ±

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

Oxygen Concentration:

• at 2 l/min: >90%. .

• at 5 l/min: 90%. (+6.5%/-3%)

(Values at 21oC and at one atmosphere pressure).

Maximum recommended  ow: 5 l/min.

The variation of the maximum recommended  ow does not

exceed ± 10 % of the indicated value when a back pressure

of 7 kPa (1 psig) is applied to the output of the device. The

maximum outlet pressure is 50 kPa (7 psig).

Electrical power supply:

115 V Units 230 V Units

Frequency: 60Hz 50 & 60Hz

Average Power: 330W(avg) 300 W(avg)

Protection Class: Class II Class II

Mains Protection: 10A 5A

Filters:

At the rear of the device: a cabinet air  lter.

At the compressor input: an inlet air  lter, 5 µm, located

behind the cabinet air  lter.

Before the oxygen outlet: a  nal product  lter, < 0.3 µm.

(technician only).

Air circulation:

A tubeaxial fan cools the compressor compartment.

Environmental limit conditions:

The performances of the device (especially the oxygen

concentration)arequotedat21oC(70oF)andoneatmosphere.

They may change with temperature and altitude. For further

information, please consult the maintenance manual.

• The device must be stored, transported and used in the

vertical position only.

• Ambienttemperatureofbetween5oCand 40oC(40oFto

104oF) operation.

• Storage temperature from -20oC to 60oC (-4oF to 160oF).

• Relative humidity of between 15 % and 95 % operation

and storage, both non-condensing.

• Altitude(21oC): Up to 2,286m (7,500ft) without degra

dation; Consult your equipment provider for further in

formation regarding 2,286m to 4000m (7,500 to

13000ft).

• Complies with EN60601-1 standard; spilling of a glass

of water.

IV. 7. Standards

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

May 20112010-8401CE Rev C 7

IV. 10. Troubleshooting.

Solutions

Check the cable connection.

Check the circuit breaker(5) on the

front of the unit; Reset if necessary.

Contact your equipment supplier.

Backup capacitor has discharged

operate unit for approximately 10

minutes and retest

Contact your equipment supplier.

Stop the device by pressing the

I-0 (ON/OFF) button and contact

your equipment supplier.

Stop the device and contact your

equipment supplier.

Stop the device and wait for it to

cool down.

Clean cabinet  lter. Restart.

Reset circuit breaker. If the device

does not start, contact your equip-

ment supplier.

Check that tubing connections are

secure and that the humidi er is

sealed.

Straighten the tubing; contact your

equipment supplier if damaged.

Power cable (9) is not correctly

plugged into the

wall outlet.

Power failure.

Oxygen concentration is too

low.

Capacitor is not charged

Internal electrical fault.

Faulty indicator.

Pneumatic connection broken

or other pressure problem.

Internal electrical fault.

Pneumatic circuit fault.

Compressor thermal safety

device has been activated.

Dirty Filters.

Fan is not working.

Tube disconnected or

humidi er cap is not tight.

Cannula tubing is kinked or

restricted.

Observations

The I-0 (ON/OFF) button is in the "I"

(ON) position but the device does not

operate.

The audible alarm sounds intermit-

tently.

Red light remains lighted.

The alarm test does not work.

See IV 4.1.

The compressor operates and the

I-0 (ON/OFF) button is in the "I"

(ON) position but the green indicator

is not lighted.

The I-0 (ON/OFF) button is in the "I"

(ON) position but there is no  ow.

The audible alarm sounds continu-

ously.

The I-0 (ON/OFF) button is in the

"I" (ON) position, the compressor is

operating and there is a  ow but the

audible alarm sounds continuously.

The compressor stops in mid-cycle,

then starts again after a few minutes.

The oxygen enriched air  ow is inter-

rupted at the nasal cannula outlet.

The  ow at the nasal cannula outlet is

irregular.

Maintenance Items

Cabinet Air Filter: Part Ref: 8400-1025; Wash weekly; Replace as needed.

Inlet Air Filter: Part Ref: 8400-1180; Inspect at each patient visit; Replace every 2 years.

Humidi er Tube: Part Ref: 8400-8409; Wash in warm water; Replace as needed.

Please record all maintenance activity on the Maintenance Log found in the Service Manual and online

at www.nidekmedical.com under the 'Maintenance Log' tab.

Possible Causes

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NOTES

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May 20112010-8401CE Rev C 11

NOTES

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2010-8401CE Rev C

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Nidek Medical Products, Inc.

3949 Valley East Industrial Drive

Birmingham, Alabama 35217 U.S.A.

Tel: 205-856-7200 Fax: 205-856-0533

info@nidekmedical.com

www.nidekmedical.com

EU Representative

mdi Europa GmbH

Langenhagener Str. 71

30855 Hannover-Langenhagen

Germany

Tel: +49-511-39-08 95 30

Fax: +49-511-39-08 95 39

info@mdi-europa.com

www.mdi-europa.com

Nidek Medical Lite User manual

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