Nidek Mark 5 Nuvo Lite Service manual (2010)

Nidek Medical Products, Inc®

Mark 5 Nuvo® Lite Oxygen Concentrator

Service Manual

Nidek Medical Products, Inc. 3949 Valley East Industrial Drive

Birmingham, Alabama 35217 USA

Telephone: [phone] • 24-Hour Fax: [phone]

Nidek is a registered trademark of Nidek Medical Products, Inc..

Mark 5 Nuvo® Lite are registered trademarks of Nidek Medical Products, Inc..

Table of Contents
General Safety

2

Instructions

Section 1.0

Production and Use of Oxygen 4
Use and Maintenance of the Device 4
Standards and Regulations 5

Introduction

1.1

1.2

1.3
Section 2.0

Home Service Provider Responsibility 6
Important Notice and Symbol Explanations 7
Functional Specifications 7

Operational Check and Concentration Test

2.1

2.2

2.3

2.4

Description of Operation
Operation Check
Alarm System

2.3.1 Power Failure Alarm test
Oxygen Concentration Test and Specification

Section 3.0
Patient Instructions

3.1

3.2

General Instructions
Routine Maintenance by the Patient

3.2.1 Cleaning the Cooling Air Inlet Filter

3.2.2 Checking the Alarm System Battery

Section 4.0
Home Service Provider Maintenance

4.1

4.2

Routine Maintenance 12

4.1.1 Cooling Air Filter 12

4.1.2 Bacteria Filter Replacement 12

4.1.3 Compressor Filter Replacement 13

4.1.4 Recording Maintenance 13

Cleaning and Infection Control 13

4.2.1 Preparing for New Patient Use 13

Section 5.0
Service

5.1

5.2

Components 14
Cabinet Removal 14

5.2.1 Removing Cabinet Back 14

5.2.2 Caster Replacement 14

8
9

9
10
10

11
12

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5.3

Compressor 14

5.3.1 Compressor Replacement 15

5.3.2 Capacitor Replacement 16

Section 6.0
Troubleshooting

6.1

5.4

5.5

5.6

5.7

5.8

5.9

5.10

5.11

5.12

5.13

5.14

5.15

6.2

6.3

6.4

6.5

Process Control Valve 16
Sieve Bed Replacement 17

5.5.1 Sieve Bed Removal 17

5.5.2 Sieve Bed Installation 17
Cabinet Fan Replacement 18
Circuit Board Replacement 18

5.7.1 Circuit Board Removal 18

5.7.2 Circuit Board Installation 19
Product Regulator Check and Setting 19

5.8.1 Product Regulator Cleaning or Rebuilding 19
Pressure Switch Replacement 20
Circuit Breaker Replacement 20

5.10.1 Circuit Breaker Removal 20

5.10.2 Circuit Breaker Installation 20
I/0 (ON/OFF) Power Switch Replacement 21

5.11.1 I/0 (ON/OFF) Power Switch Removal 21

5.11.2 I/0 (ON/OFF) Power Switch Installation 21
Buzzer Replacement 21
Hour Meter Replacement 21
Flow Valve Replacement 21

5.14.1 Flow Valve Removal 21

5.14.2 Flow Valve Installation 22
Power Cord Replacement 22

Air Pressure Test (P1) 22

6.1.1 High Air Pressure (P1) 24

6.1.2 Low Air Pressure (P1) 24
Product Pressure Test (P2) 25

6.2.1 Low Product Pressure 25

6.2.2 High Product Pressure 25
General Troubleshooting 26
Troubleshooting Chart 27
Tool Kit and Pressure Test Gauge 31

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Appendices

Exploded
Drawings

A2: OSCI Pneumatic Diagram 32
A3: 115 Volt Electrical Schematic 33
A4: 230 Volt Electrical Schematic 34
A5: 115Volt Compressor Assembly 35
A6: 230Volt Compressor Assembly 36
A7: Front Cabinet Standard Assembly 37
A8: Front Cabinet OSCI Assembly 38
A9: Back Cabinet Assembly Sandard 39
A10: Back Cabinet Assembly OSCI 40
A11: Module Assembly 5 Liter/Minute 41
A12: Module Assembly 3 Liter/Minute 42

A1:Standard Pneumatic Diagram 32

General Safety Instructions

Production and use of oxygen

Oxygen is not a flammable gas, but accelerates the combustion of materials. To

prevent fire risks, the MARK 5 NUVO Lite should be kept away from flames,

incandescent sources or sources of heat (cigarettes) and combustible products such as
oil, grease, solvents, aerosols, etc.

Do not use in an explosive atmosphere.

Prevent oxygen from accumulating on upholstered seats or any other fabric. If the

concentrator operates without being administered to a patient, locate it so that the flow
of gas generated is dissipated into the air.

Locate the equipment in a free space (filter to the rear and below) which is well
ventilated and free of fumes or atmospheric pollution.

Use and Maintenance of the Device

Use the electric cable provided and check that the voltage of the mains socket used
complies with the electrical characteristics of the appliance indicated on the
manufacturers plate on the rear of the appliance.

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Do not use an extension cord or multiple sockets which can create sparks and therefore
pose a fire risk.

Use of the MARK 5 NUVO Lite must be restricted solely to oxygen therapy on

medical prescription in compliance with the daily rate and duration.

Use in other circumstances may represent a hazard to patient health.

Do not use in a specifically magnetic environment (MRI, etc.).

The MARK 5 NUVO Lite has an audible alarm intended to warn the user of any

problems. The user must determine the maximum distance away from the Nuvo
based on the on the sound levels in the environment, to ensure that the alarm is always
audible.

Standards & Regulations
In compliance with UL60601-1 [EN60601-1] (para 6.82.b):

“The manufacturer, assembler, installer or importer are not considered to be responsible
for consequences or the safety, reliability and characteristics of a device unless,

● the assembly, extensions, adjustments modifications or repairs have been
performed by persons authorized by the manufacturer,

● the electrical installation of the corresponding premises complies with appropriate
regulations and codes,

● the device is used in accordance with the instructions for its use.

If the replacement parts used for periodic servicing by an approved technician do not
comply with the manufacturer’s specifications, the manufacturer is absolved of all
liability in the event of an incident.

Do not open the equipment when it is powered on: risk of electrocution.

This device complies with the requirements of the FDA Quality System Regulation and
EU Directive 93/42/EEC, but its operation may be affected by the use in the surrounding
area of appliances such as diathermy, high frequency electro-surgical instruments,
defibrillators, short wave treatment appliances, cell-phones, CB devices and other
portables, microwave ovens, induction hot plates or remote control toys, and more
generally, by electromagnetic interference exceeding the levels specified in standard
IEC(EN) 60601-1-2:2001.

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1.0 Introduction

1.1 Home Service Provider Responsibility

All Home Service Providers of the Nidek MARK 5 NUVO Lite Oxygen

Concentrator must assume responsibilities for handling, operational check-out,
patient instruction, and maintenance. These responsibilities are outlined below and
throughout this manual.

WARNING

MARK 5 NUVO Lite units must not be used for or with any life-supporting or life

sustaining applications. Patients unable to communicate discomfort while using this
device may require additional monitoring. Advise patients to immediately notify their
Home Service Provider(s) and/or physician(s) in case of an alarm or any discomfort.

As a Home Service Provider, you must do all of the following:

● Inspect the condition of each MARK 5 NUVO Lite unit immediately

upon delivery to your business location. Note any sign of damage,
external or internal, on the delivery receipt, and report it directly to both
the freight company and Nidek Medical Products, Inc. immediately.

● Check the operation of each MARK 5 NUVO Lite before delivery to a

patient. Always operate the unit for a reasonable length of time and check
that the oxygen concentration level is within specifications as referred to
in Section 2.4. Test the power failure alarm as described in Section 2.3 of
this manual.

● Deliver MARK 5 NUVO Lite units only to patients authorized by a
physician’s prescription. The MARK 5 NUVO Lite must not be used as

a life-supporting or life sustaining device. A backup supply of oxygen
must be available.

● Instruct patients how to use the MARK 5 NUVO Lite in conjunction with

the Users Manual.

● Instruct patients to notify their physicians and/or Home Service Providers
if they experience any signs of discomfort.

● Instruct each patient how to perform routine maintenance of the cooling
air filter and how to check the alarm system. (Refer to Section3.2.)

Be available to service each patient at any time. Maintain the MARK 5
NUVO Lite in accordance with Section 4.0.

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Repair components and replace parts only as outlined in this manual. Use only

Nidek parts for replacement in MARK 5 NUVO Lite Oxygen Concentrators.

● Refer to the MARK 5 NUVO Lite Product Warranty if parts replacement

is required within the warranty period.

1.2 Important Notice and Symbol Explanations

As you read the manual, pay special attention to the WARNING, CAUTION, and
NOTE messages. They identify safety guidelines or other important information as
follows:

WARNING:

CAUTION:

NOTE:

The following harmonized symbols (pictograms), used for non-English language

countries, will be located in the User’s Guide of the MARK 5 NUVO Lite unit:

Describes a hazard or unsafe practice that can result
in severe bodily injury or death.

Describes a hazard or unsafe practice that can result
in minor bodily injury or property damage.

Provides information important enough to emphasize
or repeat.

Read the accompanying documents; particularly the patient

operating guide.

Store, ship and use the device in an upright condition.

No smoking within five feet of this device, oxygen-carrying tubing, or

1.3 Functional Specifications
Dimensions: 35.6 cm long, 22.9 cm wide, 58.5 cm high

(14 in. long, 9 in. wide, 23 in. tall)

Weight: 13 kg 30 Ib depending on sound attenuation package

Electrical 120 VAC, 60 Hz, +/- 10% <330 watts(avg)
Requirements: 230 VAC, 50 Hz, +/- 10% <300 watts(avg)
230 VAC, 60 Hz, +/- 10% <330 watts(avg)

accessories.

Indicates an alarm signal.

Do not use any oil or grease on or near the device

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Capacity: Max. 5 liters per minute

Accuracy: Flow Valve ±10% indicated flow rate +/- 200 ml

whichever is greater as per ISO 8359 Standard

Concentration: 2 liters per minute at >90%
5 liters per minute at 90% (+ 6.5 / - 3%)
(Based on 70°F [21°C] at sea level)

Response Time: Acceptable concentration is normally achieved in about

90 seconds; allow 5 minutes to attain full concentration.

Positioning: Operate the unit in an upright position, maintaining at

least six inches of open space on all sides for ventilation.

2.0 Operational Check and Concentration Test

2.1 Description of Operation

Air enters the MARK 5 NUVO Lite Oxygen Concentrator through an external

cooling air intake filter. This filtered air enters the compressor via a suction tube and
fine filter, which quiets the suction sounds made by the compressor. Pressurized air
then exits the compressor and passes through a heat exchanger into a pair of 3­way solenoid valves. The heat exchanger reduces the temperature of the
compressed air. Next, the solenoid valve directs the air into one of two sieve beds
that contain molecular sieve. The special characteristic property of molecular sieve
is that it physically attracts (adsorbs) nitrogen when air passes through this material,
thus enabling the production of high purity oxygen.

There are two sieve beds or adsorbent columns; while one produces high purity
oxygen, the other is purged of the nitrogen it adsorbed (collected) while it was
producing oxygen. Each column produces oxygen for approximately five seconds
and delivers it to the product storage volume tank integrated into the modular bed.
Oxygen exits the product storage tank through a pressure regulator, flow control
valve, and bacteria filter. The flow control valve, controls the flow rate of oxygen

delivered to the patient. The MARK 5 NUVO Lite unit delivers up to 95% oxygen

concentration at flow rates from .125 to 5 l/min. The remaining constituents of the
product gas stream are nitrogen and argon, both of which are part of the air we
breathe, are inert and are completely safe.

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2.2 Operational Check

Nidek runs each device through a burn in period and tests every MARK 5 NUVO
Lite Oxygen Concentrator thoroughly after manufacture before releasing for

shipment. As the home service provider, it is your responsibility to perform the
following test to ensure that no damage occurred in shipping or handling.

1. Open and inspect all concentrator cartons upon receipt. Unpack each

unit and remove it from its carton. Inspect the unit itself for damage. If
the exterior of the carton is damaged, or the unit itself is damaged,
note it on the freight bill signed by the driver.

2. Plug in the power cord of the unit, and set the I/0 (ON/OFF) switch to

the I (ON) position. Check to see that the following occurs:

● The compressor runs, listen for the sound.

● Exhaust air flows out of the bottom rear of the unit.

● OPTIONAL for Units Equipped with Oxygen Concentration Status

Indicator (OCSI): The OCSI green light remains off until the oxygen
concentration reaches 85% ± 3% (82% ± 2% for 50 Hz units)
(approximately two minutes).

● After performing above steps remove the power cord from the wall
outlet. actuate the I/0 (ON/OFF) switch to the I (ON) position and
note that the audible alarm sounds intermittently. (See Section

2.3). If the unit does not initial sound off, plug the unit in and allow
the unit to run approximately 10 minutes to charge the capacitor
and re-perform the test. Move the switch to the 0 (OFF) position.

3. Turn the flow valve adjustment knob clockwise until it stops (wide
open). The flow valve should indicate 5 liters/min. and the output of
the unit should be 5 liters/min. If not, refer to Section 5.8 to adjust the
product regulator.

4 Perform an oxygen concentration test, as described in Section 2.4.

2.3 Alarm System

The MARK 5 NUVO Lite Oxygen Concentrator is equipped with a capacitor-

powered alarm system, which sounds an intermittent alarm when a power failure
occurs and a continuous alarm when one or more cycle variables are not within
specification. It sounds an alarm if the high or low pressure indicators are activated
or if the optional OCSI detects lower than predetermined levels of oxygen
concentration. The alarm remains on until you correct the alarm condition or you set

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the I/0 (ON/OFF) switch to the 0 (OFF) position. Refer to
Section 6.0 for a list of probable alarm causes.

2.3.1 Power Failure Alarm Test

To test the power failure alarm, perform the following actions:

Unplug the power cord from the wall outlet, and set the I/0 (ON/OFF) switch to the I

(ON) position.

If the unit has been stored for a prolonged period, Allow unit to run for
approximately 10 minutes to charge the capacitor and re-test the unit.

This should immediately activate the intermittent audible alarm. If it does not, refer
to the troubleshooting chart in Section 6.0 of this manual.

2.4 Oxygen Concentration Test and Specification

To ensure that the output of oxygen from the device is within specification, you must
perform an oxygen concentration test. Test the unit upon delivery to a patient and at
periodic intervals. Home Service Providers, based on their expertise and
documentation, may establish and implement their own plans for checking oxygen

concentration. Consult the proper Nidek User’s Guide for recommended interval

for testing.

1. If an oxygen humidifier bottle is used, remove it from the oxygen outlet.

2. Connect a calibrated oxygen concentration analyzer to the oxygen outlet.

3. Set the I/0 (ON/OFF) power switch to the I (ON) position. (It takes
approximately five minutes for the oxygen concentration to stabilize.) Take
oxygen concentration readings over a period of several minutes to reduce
any cyclic variations

4. Verify that the product flow rate delivered by the unit matches the patient’s

prescription and does not exceed the capacity of the unit.

5. Disconnect the oxygen analyzer, and reconnect the humidifier bottle (if used)
and any other equipment / accessories that may be required.

6. Adjust the flow valve knob to the prescribed flow rate.

NOTE:

Do not measure oxygen concentration output after the product stream passes
through a humidifier bottle, erroneous readings will result and your oxygen
concentration measuring device might be damaged.

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Nidek MARK 5 NUVO Lite Concentration Specifications

Liter Flow Specification
2 l/min greater than 90%
5 l/min 90% + 6.5 / - 3%

3.0 Patient Instructions

3.1 General Instructions

It is important that patients thoroughly understand how to operate the Nidek MARK
5 NUVO Lite unit. This enables proper treatment as prescribed by a qualified,

licensed physician. You must explain that the purpose of this therapy is to alleviate
symptoms. If patients experience any discomfort or the unit alarms, they must notify
their Home Service Provider and/or physician immediately. You, as the Home
Service Provider, are responsible to see that each patient receives the Patient
Manual. Explain each step in the operation of the unit to the patient in reference to
this manual.

3.2 Routine Maintenance by the Patient

To ensure accurate output and efficient operation of the unit, the patient must
perform two simple routine maintenance tasks:

• Clean the cooling air intake filter

• Check the alarm system

3.2.1 Cleaning the Cooling Air Intake (Cabinet) Filter
NOTE: The patient must clean this filter weekly, as described below. The filter

may require daily cleaning if the MARK 5 NUVO Lite unit operates in a harsh

environment such as a house heated by wood, kerosene, or oil, or one with

excessive cigarette smoke.

1 Remove the dirty cooling air filter from the back of the

MARK 5 NUVO Lite unit.

2 Wash the dirty filter in warm water with household

detergent, and rinse.

3 Use a soft absorbent towel to remove excess water.

4 Reinstall the clean cooling air filter on the grille in the

back of the unit.

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3.2.2 Checking the Power Alarm System

See Procedure described in Paragraph 2.3.1

4.0 Home Service Provider Maintenance

4.1 Routine Maintenance

The MARK 5 NUVO Lite unit has three filters that require scheduled maintenance

and replacement.

To ensure that the output of oxygen from the unit is within specification, you must
perform an oxygen concentration test. Test the unit upon delivery to a patient and at
periodic intervals. Home Service Providers, based on their expertise and
documentation, may establish and implement their own practices for checking
oxygen concentration. The interval established may be longer or shorter than 90
days, which is the default time period recommended for providers who do not
choose to establish their method.

Nidek does not require preventive maintenance on the concentrator. You do not

need to perform any maintenance as long as the MARK 5 NUVO Lite unit

remains within specifications at the prescribed flow rate. (Refer to Section 2.4)

4.1.1 Cooling Air Filter

The external cooling air filter is located on the back of the unit, You can easily
remove it by hand. Instruct the patient to clean this filter weekly. (Refer to Section

3.2.1.)

NOTE

The filter may require more frequent cleaning if the MARK 5 NUVO Lite unit

operates in a harsh environment such as a house heated by wood, kerosene, or oil,
or one with excessive cooking, cigarette smoke or atmospheric dust.

4.1.2 Bacteria Filter Replacement

The bacteria filter must be replaced after every 2 years or 15,000 hours of use.

1. Set the I/0 (ON/OFF) switch to the 0 (OFF) position, and unplug the power

cord.

2. Remove the cabinet back to locate the bacteria filter.

NOTE: Observe the position of the filter before removal.

3. Separate the silicone tubing from both sides of the filter.

4. Install the new filter with the inlet side in the same position as before. Push

the tubing together so that it overlaps the barbs of the bacteria filter
connections.

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5. Record information about the bacteria filter replacement on the History

Record Card, as recommended in Section 4.1.5.

6. Reinstall the cabinet back.

4.1.3 Compressor Filter Replacement

The compressor air inlet filter requires changing every 24 months or 20,000 hours of
use.

1. Set the unit I/0 (ON/OFF) switch to the 0 (OFF) position, and unplug the

power cord.

2. Remove the cooling air filter to locate the intake filter.

3. Remove filter from the unit, and replace with a new filter.

4. Record information about the filter replacement on the History Record Card

as recommended in Section 4.1.5.

5. Reinstall the cooling air filter.

4.1.4 Recording Maintenance

As the Home Service Provider, it is suggested that you record all routine

maintenance and repairs performed on the MARK 5 NUVO Lite unit, including

hours and dates of service.

4.2 Cleaning Unit

Periodically, use a damp cloth to wipe down the exterior case of the MARK 5
NUVO Lite. If you use medical disinfectants, be sure to follow manufacture’s

instructions.

4.2.1 Preparing for New Patient Use

When you remove the MARK 5 NUVO Lite from a patient’s home, always dispose

of the used nasal cannula and humidifier bottle. .

Replace the cabinet dust filter between each patient’s use or clean with warm soapy
water if it is in good condition. Clean this filter at least once per week or more
frequently if operated in a dusty environment.

Change the bacteria filter every 2 years or 15,000 hours of use (under adverse
conditions, filter may need to be changed more frequently if dingy or dirty) It is
recommended to change the bacteria filter between patients.

Retest the MARK 5 NUVO Lite before you return it to your inventory.

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