Nidek Mark 5 Nuvo 8 User manual

USER'S GUIDE

Mark 5 Nuvo 8

(OCSI)

OXYGEN CONCENTRATOR

[Original language is English]

FederalLaw(US)restrictsthisdevicetosale by, or on the order of, a licensed physician. This oxygen concentrator should be used only under the supervision of a licensed physician.

CONTENTS

GLOSSARYOFSYMBOLS..........................................1

GENERALSAFETYGUIDELINES............................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

GLOSSARYOFSYMBOLS

0413: Complies with the 93/42/ EEC directive

certi ed by the approved organization no 0413.

Danger: Donot smokewhenusing oxygen or when near this device

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

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

IV.2. Materials in direct/indirect contact with patient........4

IV.3. Operating principles..................................................5

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

IV.5. Oxygen Monitor (OCSI) 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

V. EMC, Electromagnetic statements...........................8-9

.

: 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

May 20112010-2238CE Rev C 1

GENERALSAFETY GUIDELINES

Only persons who have read and understood this entire manual

should be allowed to operate the Mark 5 Nuvo 8.

USE OFOXYGEN

Oxygen is not a  ammable gas, but it accelerates

the combustion of materials. To avoid all risks of

 re, the Mark 5 Nuvo 8 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 orotherfabrics.Iftheconcentratorisoperating 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 8 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

(MRI, X-ray, etc.)

CONFORMITYWITH IEC60601-1 (§ 6.8.2 B):

"The manufacturer, assembler, installer or distributor are not consideredtobe responsiblethemselvesfor theconsequences on 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,

• The electrical installation of the corresponding premises 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 the 93/42/EEC European directive but its operation may be affected by other devices being used near by, such as diathermy and high frequency electro-surgi-

cal equipment, de brillators, short wave therapy equipment,

mobiletelephones,CBand otherportabledevices,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.

USEAND MAINTENANCE OF 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 8 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.

2

I. DESCRIPTION

TheMark5Nuvo8isintendedtosupplysupplementaloxygen

to persons requiring low  ow oxygen therapy. It is not intended

to be life supporting or life sustaining. Itproducesan oxygen enriched product by concentrating the oxygen contained in roomair. It can beusedeitherto administer oxygenwithnasal cannulas or another probe or mask type of device.

The Mark 5 Nuvo 8 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: the performances described pertain to the use of the Mark 5 Nuvo 8 with the accessories recommended by Nidek Medical Products, Inc.

May 2011

2010-2238CE Rev C

II. STARTING UP / INSTALLATION

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4

5

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

1 - (I/0) On/Off Power Switch 2 - Humidi er (space reserved) 3 - Oxygen product outlet 4 - Flow adjustment knob (l/min) 5 - Circuit Breaker 6 - OCSI (Oxygen Concentration

Status Indicator) Indicator Lights

5

1

32

3

4

2

5

II.1. Use in direct oxygen therapy

a. Ensure that the switch (1) is in the 0 (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.

Thetubebetweenthecannula and the Mark 5Nuvo8should belimitedto20meters (60 feet)long,inordertoensurethat

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 power cable into a power outlet of the correct

voltage and frequency as de ned on the

manufacturer's technical label (8).

f. Press the power switch ( I / 0 ) to the ON position ( I ). Thegreenindicatorwill light when theoxygenconcentration

exceeds the set point. 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.

9

I.2. Rear panel (Fig. I.2) 7 - Cabinet Air Filter

8 - Manufacturer's Technical Label 9 - Power Cord

g. Turn the  ow adjustment knob (4) to the prescribed value.

This knob may have already been locked in the medically

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8

prescribed position. In this case, do not force it. Only the technician or medical personnel are authorized to release it. Note: View the  owmeter in the horizontal plane for accurate settings.

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/0 Switch to place it in the 0 (OFF) position to stop the device. The oxygen enri-

ched 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.3. Maintenance

III.1. Cleaning

Only the outside of the Mark 5 Nuvo 8 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 in ammable products must not be used. Do not use abrasive powders.

The removable cabinet air  lter (7) must be cleaned in warm

waterandhousehold detergentweekly orafterapproximately 100 hours of use. More frequent cleaning is recommended in dusty enviroments. Dry before reinstalling.

7

8

7

9

.

II.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 solutions are used.

a. The following minimum guidelines must be observed:

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6

6 Filter / Silencer 7 Cabinet Air Filter 8 Hour Meter 9 Ventilation Grille 10 Battery, if equipped

• 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 humidi er 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.

TheMark5Nuvo8mustbecleanedanddisinfectedasper the

above instructions. The cabinet air  lter should be washed or

replaced. The entire oxygen administration circuit (oxygen therapy nasal cannulas, etc.) must be changed.

4

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 8.

Note: If the concentrator unit is to be stored (not used) for a period of time exceeding 6 months, the 9 volt battery, if equipped, should be disconnected and removed.

IV. USEFUL INFORMATION IV.1.Accessories and spare parts

The accessories used with the Mark 5 Nuvo 8 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.

TheaccessorieswithaNidekMedicalpartnumber 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 BYAPHYSICIAN

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 TubingAdapter: 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 ......................................Polycarbonate

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

Cabinet air  lter ..................................................... Polyester

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

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

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

Oxygen product outlet .................................................Brass

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

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

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

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

May 2011

2010-2238CE Rev C

IV.3. Operating principle

The compressor sends  ltered ambient air to an electronic

valving system, which allows compressed air to pass to the column in production. The columns contain a molecular sieve,whosefunctionis to adsorbthenitrogenandthus allow oxygen to pass. The oxygen enriched product is then directed to a pressure

reducing valve through the adjustable  ow meter to the oxygen 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,whenone column is in production, the other is in a nitrogen desorption or "regeneration" phase. The oxygen

enriched product  nally passes through a bacterial  lter located prior to the oxygen outlet  tting.

IV.5. OCSI (oxygen concentration status indicator) function

IV.5.1. Operating principle

The oxygen monitor (6) is an electronic module capable of checking the effective oxygen concentration supplied by the Mark 5 Nuvo 8 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 Mark 5 Nuvo 8 is started, the indicator lights operates as follows:

IV.5.2. Green indicator (OCSI ONLY)

IV.4.Alarms - Safety devices IV.4.1.Alarms

• No voltage detection: In the event of a loss of mains power, a continuous audible alarm is activated and the green light turns off. Test alarm by actuating the I/0 (On/Off) switch when the power cord is not plugged into the wall receptacle.

• 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 Flow Alarm (Optional): If supplied the Nuvo 8 Oxygen Concentrator has a No Flow Alarm. This device provides an continuous audible alarm in the event the Oxygen Flow to patient becomes blocked.

IV.4.2. Safety devices

• Compressor motor: Thermal safety is ensured by a thermal switch situated in the stator winding (145 ± 5oC).

• Ambient air valve: In the case of a negative pressure in the molecular sieve columns, this valve allows ambient air to enter.

• Electrical protection of the Mark 5 Nuvo 8: A 5A circuit breaker is incorporated into the front cabinet of all 230V models.A 10Acircuit breaker is included with 115V models.

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

IV.5.3. Red indicator (OCSI ONLY) 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 lightedarelowoxygenconcentrationandlossofmainspower. The low oxygen concentration warning will light when the oxygen concentration set point level is not reached. When the red indicatorlightislightedfor15minutes(±2minutes), a continuous audible alarm is activated. Call the equipment supplier to service the device.

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 8.

IV.6. Technical characteristics

Dimensions: L x W x H: 394 x 396 x 706 mm (15.5 x 15.6 x 27.8 in.) Caster diameter: 50 mm (2.0 in.).

Tilt angle (transport with humidi er  tted): 70

o

. Weight: 24 kg /54 lbs Noise level < 53 dBA

• Class II devices with insulated castings (EN60601-1 standard)

• Safety valve:

This is  tted on the compressor outlet and is calibrated to 3.4

bar (50 psig).

May 20112010-2238CE Rev C 5

Flow values:

ContinuouslyAdjustable Flowmeter: 2 to 8 liters/minute. (Some models may have other values.)

Accuracy of  ow supplied:

IV.8. Method for disposing of waste

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

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

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

Average oxygen content:

8 l/min: 90%. +5.5% / -3.0% (Values at 21oC and at one atmosphere pressure).

Minimum recommended  ow, 2 lpm. Maximum recommended  ow, 8 lpm.

The variation of the maximum recommended  ow 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 117 kPa (17 psig).

Electrical power supply:

115V Units 230 V Units

Frequency: 60Hz 50/60Hz Average Power: 490 watts 490/585 watts 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, behind cabinet air  lter. Before the oxygen outlet: a  nal product  lter < 0.3 µm.

(technician only)

Air circulation:

One tubeaxial fan cools the compressor compartment and a second fan cools the heat exchanger coil. .

Environmental limit conditions:

Theperformanceofthedevice(especiallytheoxygenconcentration) are quoted at 21oC (70oF) and one atmosphere. 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.

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

• Storage temperature from -20oC to 60oC (0oF to 140oF).

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

• Altitude(21oC): Up to 1500m (5000ft) without degradation; Consult your equipment provider for further infor mation regarding 1500 m to 4000m (5000 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.601.1M90 w/A1&A2: Electrical Safety- Medical Devices. EN60601-1-2:2000 Electromagnetic Compatibility

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May 2011

AllwastefromtheMark5 Nuvo 8 (patient circuit,  lter, etc.) mustbedisposed ofusingthe methodsappropriateto thecivil 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 materials 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.

Nuvo 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 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 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 tech-

nicians certi ed by the manufacturer.

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

Uponrequest,the supplier canprovidecircuitdiagrams, sparepartslists,technicaldetailsoranyotherinformation

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

devicewhicharedesignatedasbeingthe manufacturer’s responsibility or by the manufacturer as repairable.

Medical Device Regulations require users and service providers to report to the manufacturerany incident that could, if repeated, result in injury to any person.

2010-2238CE Rev C

IV. 10. Troubleshooting.

Observations Possible Causes Solutions

The I-0 (ON/OFF) button is in the “I” (ON) position but the device

does not operate. The audible alarm sounds continu-

ously.

Red light remains lighted. Oxygen concentration is too low. Contact your equipment supplier. 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 con-

tinuously. 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.

Power cable (9) is not correctly plugged into the wall outlet.

Power failure. Check the circuit breaker (5) on the

Faulty 9 Volt battery.

Internal electrical fault.

Faulty indicator. Contact your equipment supplier.

Pneumatic connection broken or other pressure problem.

Internal electrical fault.

Pneumatic circuit fault.

Check the cable connection.

front of the unit; Reset if necessary.

Replace battery.

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.

The compressor stops in mid-cycle, then starts again after a few minutes.

The oxygen enriched air  ow is in-

terrupted at the nasal cannula outlet.

The  ow at the nasal cannula outlet

is irregular.

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 res-

tricted.

Stop the device and wait for it to cool down.

Clean cabinet  lter. Restart.

If the device does not start, contact your equipment supplier.

Check that tubing connections are se-

cure and that the humidi er is sealed.

Straighten the tubing; contact your equipment supplier if damaged.

Maintenance Items

Cabinet Air Filter: Part Ref: 9250-1025; Wash weekly; Replace as needed. Inlet Air Filter: Part Ref: 9250-1180; Inspect at each patient visit; Replace annually. Battery, 9 Volt: Part Ref: 7206-0027; Replace annually or sooner if needed.

Please record all maintenance activity in the Maintenance Log found in the service manual and online at www.

nidekmedical.com under the 'Maintenance Log' tab.

May 20112010-2238CE Rev C 7

V. EMC, Electromagnetic Statements

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May 2011

2010-2238CE Rev C

May 20112010-2238CE Rev C 9

NOTES

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2010-2238CE Rev C

NOTES

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May 20112010-2238CE Rev C 11

Nidek Medical Products, Inc.

3949 Valley East Industrial Drive

Birmingham,Alabama 35217 U.S.A.

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

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

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May 2011

2010-2238CE Rev C

Nidek Mark 5 Nuvo 8 User manual

Specifications and Main Features

Frequently Asked Questions

User Manual