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
Nidek Medical Products, Inc.
3949 Valley East Industrial Drive Birmingham, Alabama 35217 USA
Telephone: (205) 856-7200 • 24-Hour Fax: (205) 856-0533
Nidek Medical is a trademark of Nidek Medical Products, Inc.
Mark 5 Nuvo® is a registered trademark of Nidek Medical Products, Inc
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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
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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
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1.0 General Safety Warnings
physician. This oxygen concentrator should be used only under the supervision
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
℞Only
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
of a licensed physician.
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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
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3.0 About the Mark 5 Nuvo Lite Family
3.1 Intended 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.
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Consult your equipment provider for further information regarding altitudes of 2200 m to 4000m (7500 to
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.
13000ft).
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
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:
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.
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%.
• 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)
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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
Frequency
Average Power
Protection Class
Mains Protection
Average Oxygen Content
Average Oxygen Content
Liter Flow
Outlet Pressure
Dimensions
(L x W x H)
Weight
Noise Level
5 LPM 115V 5 LPM 230V
60 Hz 50 Hz 60Hz 50 Hz
330 Watts 300 Watts
Class II
10A 5A 5A
At 2 LPM
> 90%
At 5 LPM
87% to 95.5%
0.125 to 5 LPM 0.125 to 3 LPM
7 Psig
36 x 23 x 58.5 cm (14 x 9 x 23 in.)
14.5 kg (32 lbs.)*
< 58 dBA
3 LPM
115V
210
Watts
At 3 LPM
87% to 95.5%
3 LPM
230V
180
Watts
* Weight dependent on model and features
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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).
4.0 Service Provider (Home / Clinic / Hospital)
4.1 Responsibilities
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.
o The 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.
4.2 Operational 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.
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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.
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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.)
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