Nidek medical Mark 5 nuvo mb User manual

November 20132010-2324CE Rev A 1

USER'S GUIDE

Mark 5 Nuvo with Modular Bed

NUVO, NUVO 8 & NUVO 10

OXYGEN CONCENTRATOR

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.

0413: Complies with the 93/42/ EEC directive

certied by the approved organization no 0413.

Danger: Do not smoke when using oxygen or when

near this device

.

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

GENERAL SAFETY 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

I V. USEFUL INFORMATION ......................................... 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

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]

2010-2324CE Rev A

2November 2013

USE OF OXYGEN

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

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

the Mark 5 Nuvo MB 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 MB 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.)

USE AND 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 MB 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 with Modular Bed (MB).

CONFORMITY WITH IEC60601-1 (§ 6.8.2 B):

"The manufacturer, assembler, installer or distributor are not

considered to be responsible themselves for the consequences

on the safety, reliability and characteristics of a device

unless:

• The assembly, 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.

This device complies with the requirements of the FDA Quality

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,

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

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

I. DESCRIPTION

The Mark 5 Nuvo MB is intended to supply supplemental

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 concentrating the oxygen contai-

ned 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 MB 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 MB with the accessories recommended by

Nidek Medical Products, Inc.

5

November 20132010-2324CE Rev A 3

34

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 (if equipped)

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

7 - Cabinet Air Filter

8 - Manufacturer's Technical Label

9 - Power Cord

8

32

3

5

1

5

4

6

3

4

6

3

5

7

9

2

1

II. STARTING UP / INSTALLATION

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. The tube between the cannula and the Mark 5

Nuvo MB should be 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 power cable into a power outlet

of the correct voltage and frequency as

defined on the manufacturer's technical

label (8).

f. Press the power switch ( I / 0 ) 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.

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. 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: the required oxygen concentration is normally obtained

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:

2010-2324CE Rev A

4November 2013

III. CLEANING - MAINTENANCE

III.1. Cleaning

Only the outside of the Mark 5 Nuvo MB 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

water and household detergent weekly or after approximately

100 hours of use. More frequent cleaning is recommended in

dusty enviroments. Dry before reinstalling.

66

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 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 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.

The Mark 5 Nuvo MB must be cleaned and disinfected as

per 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.

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 MB.

IV. USEFUL INFORMATION

IV.1. Accessories and spare parts

The accessories used with the Mark 5 Nuvo MB 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).

AVAILABLE ACCESSORIES

IF PRESCRIBED BY A PHYSICIAN

Humidier: P/N 9012-8774

Humidier High Flow: P/N 9251-8774

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

Cannula High Flow: P/N 9251-8780

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/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

6 Filter / Silencer

7 Cabinet Air Filter

8 Hour Meter

9 Ventilation Grille

7

8

6

9

10

8

76

November 20132010-2324CE Rev A 5

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, 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 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

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 nally passes through a bacterial lter located

prior to the oxygen outlet tting.

IV.5. ALARMS INDICATORS

IV5.1. OCSI (oxygen concentration status indicator) if

equipped

The oxygen monitor (6) is an electronic module capable of

checking the effective oxygen concentration supplied by the

Mark 5 Nuvo MB 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 MB is started, the indicator lights

operates as follows:

IV.5.2. Green indicator

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 (OCSI equipped

). On initioal power up it will ash green until the unit has

reached normal operating conditions.

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.) (Nuvo 10 H: 760mm (29.8))

Caster diameter: 50 mm (2.0 in.).

Tilt angle (transport with humidier tted): 70o.

Weight: 24 kg /54 lbs

Noise level within ISO 8359 guidelines

Flow values:

Continuously Adjustable Flowmeter: 1 to 5, 2 to 8, or 2 to

10 (depending on model)

IV.5.3. Red indicator

IV.5.4. Maintenance of the device 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%.

• The equipment supplier checks that the device is still

operating correctly when the routine checks are performed

on the Mark 5 Nuvo MB.

IV.4. Alarms - Safety devices

IV.4.1. Alarms

• No voltage detection:

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/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 MB 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 ± 5 oC).

• Electrical protection of the Mark 5 Nuvo MB:

A 5A circuit breaker is incorporated into the front cabinet of all

230V models, except NUVO 10 which is 10A. 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 3.4

bar (50 psig).

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 abnormal pressures.

For OCSI units the low oxygen concentration warning will

light when the oxygen concentration set point level is not

reached. When 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.

2010-2324CE Rev A

6November 2013

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 degrada-

tion; 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.

EN 60601-1[UL60601-1:2003],CAN/CSA-C22.2 No.601.1-

M90 w/A1&A2: Electrical Safety- Medical Devices.

EN60601-1-2:2000 Electromagnetic Compatibility

IV.8. Method for disposing of waste

All waste from the Mark 5 Nuvo MB (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 owmeter, accurate to within ±

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

Average oxygen content:

5 1/min, 8 l/min, 10 1/min: 90%. +5.5% / -3.0%

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

Minimum recommended ow: 1 l/min on 5L unit, 2 l/min

on 8 & 10L units.

Maximum recommended ow: 5 l/min, 8 l/min or 10 l/min

model specic.

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: 7psig for 5 l/min, 15 psig for 8

l/min, and 20 psig for 10 l/min.

Electrical power supply:

5 l/min Model: 115 V Units 230 V Units

Frequency: 60Hz 50/60Hz

Average Power: 410 watts 420 watts

Protection Class: Class II Class II

M a i n s P r o t e c t i o n : 1 0 A 5 A

8l/min Model: 115 V Units 230 V Units

Frequency: 60Hz 50/60Hz

Average Power: 490 watts 490 watts

Protection Class: Class II Class II

Mains Protection: 10A 5A

10 l/min Model: 115 V Units 230 V Units

Frequency: 60Hz 50/60Hz

Average Power: 700 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 on 8 & 10 lpm models.

.

Environmental limit conditions:

The performance of the device (especially the oxygen concen-

tration) are quoted at 21oC (70oF) and one atmosphere. They

may change with temperature and altitude. For further infor-

mation, 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

Nuvo Serial No. ___________________________

Date rst used: ___________________________

_________________________________________

Maintained by: ___________________________

_________________________________________

Your distributor: _________________________

Address : ________________________________

_________________________________________

Telephone : ______________________________

November 20132010-2324CE Rev A 7

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 technicians

certied by the manufacturer.

Use original spare parts only (see Pg. 8).

Upon request, the supplier can provide circuit diagrams, spare

parts lists, technical details or any other information of use

to qualied 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.

NOTES

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NOTES

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2010-2324CE Rev A

8November 2013

IV. 10. Troubleshooting.

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.

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.

Observations Possible Causes Solutions

The I-0 (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.

The audible alarm sounds intermit-

tantly.

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

front of the unit; Reset if necessary.

Red light remains lighted. Oxygen concentration is too low.

or pressures are out of specied

range.

Contact your equipment supplier.

The alarm test does not work. See

IV 4.1.

Capacitor is charged

Internal electrical fault.

Plug unit in for 10 minutes and retest

Contact your equipment supplier.

The compressor operates and the I-0

(ON/OFF) button is in the “I” (ON)

position but the green indicator is

not lighted.

Faulty indicator. Contact your equipment supplier.

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

“I” (ON) position but there is no

ow. The audible alarm sounds con-

tinuously.

Pneumatic connection broken or

Nidek Medical Mark 5 Nuvo MB User manual

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