Nidek Mark 5 Nuvo Lite Service manual (2013)

Nidek Medical Products, Inc®

Mark 5 Nuvo® Lite Oxygen Concentrator

Service Manual for Serial Numbers beginning 013-XXX

Nidek Medical Products, Inc.

3949 Valley East Industrial Drive Birmingham, Alabama 35217 USA

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

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

Mark 5 Nuvo® Lite is a registered trademark of Nidek Medical Products, Inc

Table of Contents

General Safety Instructions

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

Section 1.0 Introduction

1.1

1.2

1.3

Home Service Provider Responsibility
Important Notice and Symbol Explanations
Functional Specifications

Section 2.0 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
No Oxygen Flow Alarm test Procedure

2.5

Section 3.0 Patient Instructions

3.1

3.2

General Instructions
Routine Maintenance by the Patient

3.2.1 Cleaning the Cabinet Air Filter

3.2.2 Checking the Power Alarm System

Section 4.0 Home Service Provider Maintenance

4.1

Routine Maintenance

4.1.1 Cabinet Air Filter

4.1.2 Final Product Filter Replacement

4.1.3 Compressor Inlet Air Filter Replacement

4.1.4 Recording Maintenance

2

5
5
5

6
7
8

9

9
10
10
10
11

10
11
11
12

12
12
12
13
13

Section 5.0 Service

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4.2

5.1

5.2

5.3

5.4

5.5

Cleaning Unit

4.2.1 Preparing for New Patient Use

Components
Cabinet Removal

5.2.1 Removing Cabinet Back

5.2.2 Caster Replacement

Compressor

5.3.1 Compressor Replacement

5.3.2 Capacitor Replacement

Process Control Valve
Sieve Bed Replacement

5.5.1 Sieve Bed Removal

5.5.2 Sieve Bed Installation

13
13

13
14
14
14

14
15
16

16
16
17
17

5.6

Cabinet Fan Replacement

17

5.7

5.8

5.9

5.10

5.11

5.12

5.13

5.14

5.15

Section 6.0 Troubleshooting

6.1

6.2

6.3

6.4

6.5

Exploded Drawings / Parts

A-1:
A-2:
A-3
A-4
A-5
A-6:
A-6-A:
A-7:
A-7-A:
A-8:
A-8-A:
A-9:
A-9-A:
A-10:

Circuit Board Replacement

5.7.1 Alarm Circuit Board Removal

5.7.2 Timing Circuit Board Removal
Product Regulator Check and Setting

5.8.1 Product Regulator Cleaning or Rebuilding
Pressure Monitoring Board Replacement
Circuit Breaker Replacement

5.10.1 Circuit Breaker Removal

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

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

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

5.14.1 Flow Valve Removal

5.14.2 Flow Valve Installation
Power Cord Replacement

Air Pressure Test (P1)

6.1.1 High Air Pressure (P1)

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

6.2.1 Low Product Pressure

6.2.2 High Product Pressure
General Troubleshooting
Troubleshooting Chart
Tool Kit, Oxygen Purity Testing and Pressure Test

Gauge

18
18
18
18
19
19
19
19
19
20
20
20
20
20
20
20
20
20

21
23
23
23
24
24
25
26
28

Flow Schematic – OCSI Option 29
Flow Schematic – Standard Option 29
Flow Schematic – No Flow Alarm 30
115 / 230 Volt Electrical Schematic 31
Electrical Schematic – No Flow Alarm 33
Compressor Assembly 34
Parts, Compressor Assembly 35
Front Cabinet Assembly 36
Parts, Front Cabinet Assembly 37
Back Cabinet Assembly 38
Parts, Back Cabinet Assembly 39
Module Assembly 40
Parts, Module Assembly 41
Service and Maintenance Log 42

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 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
(including 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 product gas produced 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 manufacturer's plate on the rear of the
device.

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 medically prescribed oxygen therapy in
compliance with the prescribed 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 Lite 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 distributor are not considered to be responsible themselves
for the consequences on the safety, reliability and characteristics of a device unless the:

• Assembly, fitting, extensions, adjustments, modications or repairs have been performed by persons
authorized by the party in question.

• Electrical installation of the corresponding premises complies with local electrical codes. (e.g. IEC /
NEC).

• Device is used in accordance with the instructions for use.
If the replacement parts used for the periodic servicing by an approved technician do not comply with

the manufacturer’s specications, the manufacturer is not responsible in the event of an accident.

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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 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.

As a regulated medical device, both manufacturers and service providers have certain responsibilities
regarding complaints.

FDA defines a complaint as any written, electronic or oral communication that alleges
deficiencies related to the identity, quality, durability, reliability, safety, effectiveness or
performance of a device that has been released for distribution.

Service providers have a responsibility to evaluate any complaints received from their direct

customers. ( Ref. CFR 820.198 ). Nidek Medical does not have direct links to your customers.

Your evaluation should include the following:

 Determine if the complaint warrants action by Nidek Medical,

 If NO, resolve the complaint with your customer,

 If YES, contact Nidek Medical customer service,

 Work with Nidek Medical to resolve all complaints.

1.0 Introduction

1.1 Home Service Provider Responsibility

All Home Service Providers of the Nidek Medical MARK 5 NUVO Lite Oxygen Concentrator must
assume responsibilities for handling, operational testing, 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 immediately report it directly to both the freight company and Nidek Medical Products,
Inc.



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 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 and patient caregivers how to use the MARK 5 NUVO Lite in conjunction

with the Users Manual.

 Instruct patients and patient caregivers to notify their physicians and/or Home Service

Providers if they experience any signs of discomfort.

 Instruct each patient and patient caregivers how to perform routine maintenance of the

cabinet air filter and how to check the alarm system. (Refer to Section 3.2.)
Be available to service each patient at any time. Maintain the MARK 5 NUVO Lite in
accordance with Section 4.0.

Repair components and replace parts only as outlined in this manual. Use only Nidek Medical 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: Describes a hazard or unsafe practice that can result in severe bodily

injury or death.

CAUTION: Describes a hazard or unsafe practice that can result in minor bodily

injury or property damage.NOTE:Provides information important
enough to emphasize or repeat.

NOTE Provides information important enough to emphasize or repeat.

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The following harmonized symbols (pictograms) are located in the User’s Guide of the MARK 5 NUVO
Lite unit:

Read the accompanying documents; particularly the User's Guide

Store, ship and use the device in an upright condition

No smoking within 2 meters (six feet) of this device, oxygen-carrying

tubing, or accessories.

Indicates an alarm signal for low oxygen concentration or other problem

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

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: 14.5 kg [32 Ib] varies with sound attenuation package
Electrical 115 VAC, 60 Hz, +/- 10% <330 watts(avg)
Requirements: 230 VAC, 50 Hz, +/- 10% <300 watts(avg)

230 VAC, 60 Hz, +/- 10% <330 watts(avg) (280 W for 3 l/min unit)
Capacity: Max. 5 liters per minute ( 3 l/min for 925/60K )
Accuracy: Flow Valve ±10% indicated flow rate or +/- 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 21°C [70°F] 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 15 cm (six inches) of open space on all sides for ventilation.

.

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2.0 Operational Check and Concentration Test

2.1 Description of Operation

Air enters the MARK 5 NUVO Lite Oxygen Concentrator through an external cabinet air 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 3-way 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 sieve module. Oxygen exits the product storage tank through a pressure regulator, flow control
valve, and final product 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

0.125 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.

2.2 Operational Check

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

3. The compressor runs, listen for the sound.

4. Exhausted cooling air flows out of the bottom rear of the unit.

5. 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).

6. OPTIONAL for Units Equipped with No Oxygen Flow Alarm Board: The No Oxygen Flow board
test should be preformed as in Section 2.5 of this manual.

7. After performing the 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 initially sound off, plug the unit in and allow the unit to
run approximately 10 minutes to charge the capacitor and repeat the test. Move the switch to
the 0 (OFF) position.

8. 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.

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

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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 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:

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

2. 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.

3. 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 Nidek Medical’s Service and Maintenance Log (A-

11) for the recommended maximum intervals 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 adjustment knob to the prescribed flow rate.

Nidek Medical MARK 5 NUVO Lite Concentration Specifications

Liter Flow Specification

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

 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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2.5 No Oxygen Flow Alarm Test Procedure

A No Oxygen Flow Alarm board is available as an option with the Nuvo Lite
Oxygen Concentrator. To test the function of “No Flow” alarm if so equipped, follow the instructions
below:

1. Turn Concentrator on and allow the unit to reach normal operating purity.

2. Adjust the Oxygen Flow to desired flow rate.

3. Block the oxygen flow at the patient outlet

4. A continuous audible alarm should sound as long as the Oxygen flow is blocked

3.0 Patient Instructions

3.1 General Instructions

It is important that patients thoroughly understand how to operate the Nidek Medical 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 alarm sounds, 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 User's Guide.
Explain each step in the operation of the unit to the patient in reference to that guide.

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 cabinet air filter

• Check the alarm system

3.2.1 Cleaning the Cabinet Air Filter

● NOTE: The patient must clean this filter weekly, as described below. 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 cigarette smoke.

1. Remove the dirty cabinet 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 cabinet air filter on the grille in the back of the unit. Be careful that the filter
edges are under the tabs.

3.2.2 Checking the Power Alarm System

See Procedure described in Paragraph 2.3.1

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4.0 Home Service Provider Maintenance

4.1 Routine Maintenance

The MARK 5 NUVO Lite unit has three filters that require inspection and scheduled maintenance or

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, should 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
own method.

Nidek Medical 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 Cabinet Air Filter

The external cabinet 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 Final Product Filter Replacement

The final product filter does not require periodic replacement; it needs to be replaced only if it restricts
oxygen flow. It is suggested that it be replaced whenever the sieve module is repaired or replaced and
after the compressor is rebuilt.

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

2. Remove the upper upper cabinet back to locate the final product filter.

NOTE: Observe the position of the filter ( flow direction ) 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 final product filter connections.

5. Record information about the final product filter replacement in Appendix 11 of this manual and
online at www.nidekmedical.com under the ‘Maintenance Log’ tab.

6. Reinstall the upper upper cabinet back.

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4.1.3 Compressor Inlet Air Filter Replacement

The inlet air filter requires inspection at each patient visit. The filter should be replaced every 2 years,
or more often depending on environment.

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

2. Remove the cabinet air filter to locate the inlet air filter.

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

4. Record information about the filter replacement in Appendix 11 of this manual and online at
www.nidekmedical.com under the ‘Maintenance Log’ tab.

5. Reinstall the cabinet air filter.

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.

4.1.4 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 in Appendix 11 of this
manual and online at www.nidekmedical.com under the ‘Maintenance Log’ tab.

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. Inspect the humidifier tube and clean or replace as needed.

Replace the cabinet air 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.

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

5.0 Service

5.1 Components

The design of the Nidek Medical MARK 5 NUVO Lite Oxygen Concentrator allows for easy access and
removal of most components. This allows you to perform scheduled maintenance, repair, and
replacement of parts with minimal time and effort. The inlet air filter is conveniently located behind the
cabinet air filter on the upper cabinet back.
Caution: For your safety, be sure to set the I/0 (ON/OFF) switch to 0 (OFF) position and unplug the
power cord before you service the MARK 5 NUVO Lite Oxygen Concentrator.
Note: Record all scheduled maintenance on the Maintenance Log found in Appendix 10.
(Refer to Section 4.1.4)

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