Nidek Mark 5 Nuvo Lite Service manual (2018)

SERVICE MANUAL

Mark 5 Nuvo® Lite Family

(Nuvo Lite and Nuvo Lite 3)

For models: 520, 525, 535, 920, 925, and 935

And serial numbers beginning 132-XXXXX

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® is a registered trademark of Nidek Medical Products, Inc

2010-8407 Rev E

April 30, 2018

Page 1 of 35

		Contents
1.0	General Safety Warnings........................................................................................................................................		4
2.0	Glossary of Symbols ...............................................................................................................................................		5
3.0	About the Mark 5 Nuvo Lite Family .......................................................................................................................		6
3.1		Intended Use and Operation .............................................................................................................................	6
3.2		Installation and Storage .....................................................................................................................................	6
3.3		Alarms and Safety Features ...............................................................................................................................	7
3.4		Device Performance and Specifications.............................................................................................................	8
4.0	Service Provider (Home / Clinic / Hospital)............................................................................................................		9
4.1		Responsibilities ..................................................................................................................................................	9
4.2		Operational Check..............................................................................................................................................	9
4.3		Patient / Caregiver Instruction.........................................................................................................................	11
5.0	Service Technicians ..............................................................................................................................................		11
5.1		Testing and Troubleshooting ...........................................................................................................................	11
5.2		Troubleshooting Chart .....................................................................................................................................	15
5.3		Component Removal / Replacement Instruction ............................................................................................	16
5.3.1		Remove Cabinet Back .................................................................................................................................	16
5.3.2		Remove Caster(s)........................................................................................................................................	16
5.3.3 Replace Inlet / Silencer Filter ......................................................................................................................			17
5.3.4 Replace Final Product Filter ........................................................................................................................			17
5.3.5		Replace Compressor ...................................................................................................................................	17
5.3.6		Replace Capacitor .......................................................................................................................................	18
5.3.7		Replace Control Valve.................................................................................................................................	18
5.3.8		Replace Sieve Module.................................................................................................................................	18
5.3.9		Replace Cabinet Fan....................................................................................................................................	19

2010-8407 Rev E

April 30, 2018

Page 2 of 35

5.3.10		Replace Circuit Board (OCSI and Pressure) .............................................................................................	19
5.3.11		Adjust Regulator ......................................................................................................................................	20
5.3.12		Clean / Rebuild Regulator........................................................................................................................	20
5.3.13		Replace Circuit Breaker ...........................................................................................................................	21
5.3.14		Replace Power Switch .............................................................................................................................	21
5.3.15		Replace Buzzer ........................................................................................................................................	21
5.3.16		Replace Hour Meter ................................................................................................................................	21
5.3.17		Replace Flow Valve..................................................................................................................................	22
5.3.18		Replace Power Cord ................................................................................................................................	22
5.4	Tools Required - Test Equipment / Gauges Available......................................................................................		22
6.0	Schematics / Assembly Drawings / Part Callouts.................................................................................................		23
6.1	Flow Schematic (OCSI models) ........................................................................................................................		23
6.2	Flow Schematic (Standard models) .................................................................................................................		23
6.3	Electrical Schematic (all models) .....................................................................................................................		24
6.4	Compressor Assembly / Parts Callout..............................................................................................................		25
6.5	Front Cabinet Assembly / Parts Callout ...........................................................................................................		27
6.6	Back Cabinet Assembly / Parts Callout ............................................................................................................		29
6.5	Module Assembly / Parts Callout.....................................................................................................................		31
Appendix A		Service and Maintenance Log .................................................................................................................	33
Conformity with EN 60601-1............................................................................................................................................			35

2010-8407 Rev E

April 30, 2018

Page 3 of 35

1.0 General Safety Warnings

This unit is not a life-support device. Geriatric, pediatric, or any other patient unable to communicate discomfort while using this device should receive additional monitoring.

This device supplies highly concentrated oxygen enriched product gas that promotes rapid burning.

DO NOT allow smoking or open flames within the same room of this device or the administration accessory (cannula).

Failure to observe this warning can result in severe fire, property damage, and / or cause physical injury or death.

Oxygen accelerates the combustion of flammable substances.

DO NOT use oil, grease, petroleum based or other flammable products on the device, the administration accessory (cannula) or the patient’s face / neck.

Only persons who have read and understood this entire manual should be allowed to service the device.

CONTRAINDICATIONS - Those who continue to smoke (because of the increased fire risk and the probability that the poorer prognosis by smoking will offset the treatment benefit).

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

Only

of a licensed physician.

2010-8407 Rev E

April 30, 2018

Page 4 of 35

2.0 Glossary of Symbols

ON (Power switched on)

OFF (Power switched off)

Manufacturer Name and Address

Type B Device

Class II Protection

IPX1 Protection from vertically falling water drops

Do Not Expose to Open Flames

Do Not Expose to Oil or Grease

Tools Required / Technician Only

Refer to Technical Information / Service Manual

Refer to Instructions for Use / User’s Guide

Keep in Vertical Position

FRAGILE – Handle with Care

Visual Alarm Indicator

WARNING – A hazard or unsafe practice that can result in serious injury or death if conditions are not avoided.

Caution - A hazard or unsafe practice that can result in minor injury and / or property damage if conditions are not avoided.

Note – Information important enough to emphasize or repeat

2010-8407 Rev E

April 30, 2018

Page 5 of 35

3.0About the Mark 5 Nuvo Lite Family

3.1Intended Use and Operation

The Mark 5 Nuvo Lite Family (Nuvo Lite and Nuvo Lite 3) Oxygen Concentrators are used as a means of providing continuous oxygen enriched product gas for patients, adolescent to geriatric, suffering from health conditions that cause low levels of oxygen in the blood (hypoxaemia).

The Mark 5 Nuvo Lite Family begins their operation with air being pulled into the external air intake filter. This filtered air enters the compressor via a suction resonator and fine filter. Pressurized air then exits the compressor and passes through a heat exchanger, which reduces the temperature of the compressed air. Next, an electronic valve system directs the air into one of two tubes that contain molecular sieve (sieve beds). The molecular sieve adsorbs (physically attracts) the nitrogen from the air as it is pushed through the sieve beds. This allows the oxygen enriched product gas to pass through before being delivered to the pressure regulator. As one tube is generating the product gas, the other is being purged of the adsorbed nitrogen, this process is called pressure swing adsorption (PSA). After passing through the regulator, the rate of product gas being delivered to the patient is set by the flow meter adjusting valve. Finally, it passes through a fine particle filter and then over a sensor that detects the oxygen concentration of the product gas before it exits the device through a fire resistant outlet.

Make sure during operation and after shut down that the cannula is facing away from soft surfaces and clothing. Excess oxygen can accumulate and cause ignition if exposed to a spark or open flame.

Use the power cord provided.

Check that the electrical characteristics of the power outlet used match those indicated on the manufacturer’s technical label on the rear panel of the device.

This unit may be equipped with a polarized plug. That is one blade wider than the other. If it does not fit into the outlet, reverse the plug. If it still does not fit, contact a qualified electrician. Do not defeat this safety feature.

3.2 Installation and Storage

The device should be operated in a dry area, with an ambient temperature between 10°C to 40°C (50°F to 105°F) at 15-95% relative humidity. The device can be operated at an altitude of up to 2200m (7500ft) at a temperature of 21°C (70°F) without causing product degradation.

DO NOT use in explosive atmosphere.

To avoid risk of fire and explosion the concentrator should be kept away from heat sources, incandescent sources, solvents, Aerosols, etc.

Unit should be placed and operated in a well-ventilated space that is free of pollutants or fumes and protected from the elements with adequate lighting.

Unit should be placed and operated in a space where the position and storage of the mains cable and oxygen tubing do not present a tripping hazard.

The mains cable should be easily accessible for disconnection.

For patient safety and benefit, no modification to the equipment is allowed.

It is also not recommended to interconnect the device with any equipment or accessories not specified in this guide.

Device must have power to operate.

In the event of power loss and for continued operation a backup source is recommended.

Do not use in a specifically magnetic environment (MRI, X-ray, etc.). May cause device malfunction.

We recommend against the use of extension cords and adapters, as they are potential sources of sparks and fire.

2010-8407 Rev E

April 30, 2018

Page 6 of 35

Consult your equipment provider for further information regarding altitudes of 2200 m to 4000m (7500 to 13000ft).

The device should be stored in a dry area, with an ambient temperature between -20°C to 60°C (0°F to 140°F) at 1595% relative humidity. It must be stored, transported and used in the vertical position only.

Oxygen concentration can be affected after prolonged periods of storage – check device before use.

3.3 Alarms and Safety Features

Each device is equipped with indicator lights (green and yellow) and auditory indicators to identify various operational modes. Devices manufactured prior to 2018 were equipped with red and yellow indicator lights. The alarm modes are described below:

The device 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.

If any of the below alarm conditions occur, press the Power Switch to the “O” (OFF) position. Refer to the Troubleshooting Guide in §5.2 for the possible cause and solution.

No voltage detection: In the event of a loss of mains power, an intermittent audible alarm is activated and the green light is no longer illuminated.

Oxygen Concentration Status Indicator: If supplied, in the event that the oxygen concentration falls below the set point percentage, a continuous audible alarm and the yellow indicator light will actuate. The oxygen concentration monitor is an electronic module capable of checking the effective oxygen concentration supplied by the concentrator. When the device is started, the green indicator light will flash until the concentration set point is reached (approximately two minutes).

A solid green indicator light means the power is applied to the concentrator and that it is ready to provide oxygen enriched air to the patient.

No special maintenance is required. The alarm set-point is factory set and the setting cannot be adjusted. All OCSI models are set at 85% ± 3%.

Blocked Cannula detection: If supplied, the device has a Blockage Alarm. A continuous audible alarm and both indicator lights will be lit immediately in the event the flow of oxygen to patient becomes blocked.

Malfunction detection: If low pressure occurs due to a mechanical failure, the indicator light will flash yellow and a continuous audible alarm will actuate.

Thermal safety: The compressor motor is protected by a thermal switch situated in the stator winding (145 ± 5° C). One tubeaxial fan cools the compressor compartment.

Electrical protection:

•A 5A circuit breaker is incorporated into the front cabinet of all 230V models

•A 10A circuit breaker is incorporated into the front cabinet of all 115V models

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

Safety valve: This is fitted on the compressor outlet and is calibrated to 3.4 bar (50 psig).

Fire Break: This device is fitted with a metal fire break at the Oxygen Product Outlet. This break will keep fire from entering the device.

2010-8407 Rev E

April 30, 2018

Page 7 of 35

3.4 Device Performance and Specifications

The performance of the device (especially the oxygen concentration) is quoted at 21°C (70°F) and one atmosphere. The specifications may change with temperature and altitude.

Model	520		525	920		925	535	935
Description	5 LPM 115V			5 LPM 230V			3 LPM	3 LPM
							115V	230V
Frequency		60 Hz			50 Hz		60Hz	50 Hz
Average Power	330 Watts			300 Watts			210	180
							Watts	Watts
Protection Class					Class II
Mains Protection		10A			5A		5A
Average Oxygen Content					At 2 LPM
					> 90%
Average Oxygen Content			At 5 LPM				At 3 LPM
			87% to 95.5%				87% to 95.5%
Liter Flow			0.125 to 5 LPM				0.125 to 3 LPM
Outlet Pressure					7 Psig
Dimensions
(L x W x H)			36 x 23 x 58.5 cm (14 x 9 x 23 in.)
Weight				14.5 kg (32 lbs.)*
Noise Level					< 58 dBA

*Weight dependent on model and features

In compliance with EN ISO 80601-2-69, the flow supplied is equal to the flow set on the flowmeter, accurate to within ± 10% or 200 ml/min, whichever is greater.

The variation of the maximum recommended flow 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.

Complies with EN 60529:2001 + A2:2014 rating of IPX1; enclosure protects internal electrical components against vertically falling water drops.

Complies with EN 60601-1:2006 [11.6.3]; enclosure protects internal electrical components against spilling of a glass of water (i.e. contents of humidifier).

2010-8407 Rev E

April 30, 2018

Page 8 of 35

4.0Service Provider (Home / Clinic / Hospital)

4.1Responsibilities

Service Providers of the Mark 5 Nuvo Lite Family (Nuvo Lite and Nuvo Lite 3) Oxygen Concentrators must assume responsibilities for handling, operational testing, patient instruction, and maintenance. These responsibilities are outlined below and throughout this manual.

To ensure patient safety, use only after one or more settings have been individually determined or prescribed for the patient at their specific activity levels – AND – only use the accessories that were used when the settings were determined.

While undergoing oxygen therapy, if the patient feels discomfort or experiences a medical emergency, seek medical assistance immediately.

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

•Inspect the condition of each device immediately upon delivery to your location. Note any sign of damage, on the delivery receipt, and immediately report it directly to both the freight company and Nidek Medical Products, Inc.

•Ensure the operation of each device before delivery to a patient by completing the “Operational Check” provided in §4.2.

•Ensure each device has been thoroughly cleaned, the cabinet filter has been cleaned or replaced, and the nasal cannula and tubing has been replaced before delivering the device to a new patient or between patients.

•Deliver device only to patients authorized by a physician’s prescription. The device must not be used as a life-supporting or life sustaining device.

•Ensure a backup supply of oxygen is available.

•Instruct patients and patient caregivers how to use the device in conjunction with the Instructions for Use (PN 2010-8401CE), including required routine maintenance and cleaning of the device and filters. See “Patient / Caregiver Instruction” provided in §4.3.

•Record and notify Nidek Medical of any and all complaints provided by the patient or patient caregiver.

oThe 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 after it is released for distribution.”

•Be available to service each patient at any time.

•Keep service records of each device. A form approved by Nidek Medical has been provided in Appendix A.

•Repair components and replace parts only as outlined in this manual. Use only Nidek Medical parts for replacement. Refer to the Product Warranty Statement if parts replacement is required within the warranty period.

4.2Operational Check

Nidek Medical runs each device through a burn in period and tests every device thoroughly after manufacture before releasing it for shipment. As the Service Provider, it is your responsibility to perform the following check to ensure that the device is operational.

2010-8407 Rev E

April 30, 2018

Page 9 of 35

1.Plug in the power cord of the unit, following the electrical characteristics noted on the technical label, and set the Power Switch to the I (ON) position. The compressor should begin running.

2.Once the device has been running for approximately ten minutes, verify the concentration is within specifications, the flow is accurate and the alarms are operational. For units equipped with the Oxygen

Concentration Status Indicator (OCSI) (models 525, 535, 925, 935), the green indicator light will flash until the oxygen concentration reaches 85% ± 3% (approximately two minutes).

a.Verify oxygen concentration by:

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

1.If an oxygen humidifier bottle is used, remove it from the oxygen outlet. The concentration readings of the product gas after it has passed through a humidifier bottle will be erroneous and can result in damage to your analyzer.

2.Oxygen analyzers are available for purchase from Nidek Medical (see §5.4 for testing equipment part numbers).

ii.Set the flow rate of the device to the prescribed rate of the patient.

iii.Record oxygen concentration readings over a period of several minutes to reduce any cyclic variations. These readings should fall within the specifications provided in §3.4.

1.If not, refer to the troubleshooting chart in §5.2 for possible causes and solutions.

b.Verify the flow is accurate by:

i.Connect a calibrated flow gauge to the oxygen outlet.

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

2.Gauges are available for purchase from Nidek Medical (see §5.4 for testing equipment part numbers).

ii.Turn the flow knob clockwise until it stops (wide open).

iii.The reading should indicate 5 liters/min. (models 520, 525, 920 and 925) or 3 liters/min (models 535 and 935).

1.If not, refer to §5.3.11 for adjusting the regulator, or refer to the troubleshooting chart in §5.2 for other possible causes and solutions.

c.Verify alarms are operational by:

i.No Voltage Alarm

1.Unplug the power cord from the wall outlet.

2.Set the Power Switch to the I (ON) position.

3.This should immediately activate the intermittent audible alarm and there should be no indicator lights actuated.

a.If it does not, refer to the troubleshooting chart in §5.2 for possible causes and solutions.

ii.Blockage Alarm

1.Adjust the Flow Knob to desired flow rate.

2.Block the oxygen flow at the patient outlet

3.This should immediately activate a continuous audible alarm and both indicator lights should be actuated.

a.If it does not, refer to the troubleshooting chart in §5.2 for possible causes and solutions.

2010-8407 Rev E

April 30, 2018

Page 10 of 35

4.3 Patient / Caregiver Instruction

It is important that the patient and/or caregiver thoroughly understands how to operate their device. 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 the patient experiences any discomfort or the unit alarm sounds, they must notify their Service Provider and/or physician immediately. You, as the Service Provider, are responsible to see that each patient receives the Instructions for Use (IFU) (PN 2010-8401CE) and understands how to operate, clean and maintain their device.

•Refer to §4.2 in the IFU for the Start-Up procedure.

•Refer to §4.3 in the IFU for the Shut Down procedure.

•Refer to §5.1 in the IFU for the Cleaning procedures of the device itself, the filters and the accessories.

•Refer to §5.2 in the IFU for the Maintenance procedure.

Refer to §5.3.3 and §5.3.4 of this manual for instruction on replacing the inlet and final product filters.

5.0 Service Technicians

The design of the Mark 5 Nuvo Lite Family (Nuvo Lite and Nuvo Lite 3) 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.

•Refer to §5.2 for the Troubleshooting Chart for a list of problems, possible causes and solutions.

•Keep service records of each device. A form approved by Nidek Medical has been provided in Appendix A.

•Repair components and replace parts only as outlined in this manual. Use only Nidek Medical parts for replacement.

•Refer to the Product Warranty Statement if parts replacement is required within the warranty period.

•Analyzers and gauges are available for purchase from Nidek Medical, see §5.4 for part numbers.

For your safety, be sure to set the Power Switch to O (OFF) position and unplug the power cord before you service the device.

5.1 Testing and Troubleshooting

Before reviewing the troubleshooting chart, the following questions may be useful to isolate any malfunctions.

1.Does the concentrator turn on when the switch is activated?

2.Are the filters clean?

3.Connect an oxygen analyzer to the outlet fitting of the device. Set the flow to 2LPM, is the concentration greater than 90%? Set the flow at 5 LPM (or 3LPM for models 535 and 935), is the concentration between 87 and 95.5%?

4.Connect test pressure gauge to the outlet fitting of the unit. Does the pressure read 7.1 psig (49 kPa) ± 20%?

5.Perform an air pressure test (P1). Does the pressure cycle between 10-15 and 25-32 psig approximately (70103 and 172-220 kPa)?

a.Remove the upper cabinet back (see §5.3.1 for instructions).

b.Remove the air supply tubing going to the control valve and install the test port tee fitting. (See Figures 5.1.1 and 5.1.2 below for Normal Operating Configuration and Test Port Configuration.)

2010-8407 Rev E

April 30, 2018

Page 11 of 35