Nidek Medical Mark5 Nuvo User manual

Nidek Medical Products, Inc®
Mark5 Nuvo® [M5C5] Oxygen
Concentrator Service Manual
Nidek Medical Products, Inc. 3949 Valley East Industrial Drive
Birmingham, Alabama 35217 USA
Telephone: [phone] • 24-Hour Fax: [phone]

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Nidek Medical is a trademark of Nidek Medical Products, Inc.
Mark5 Nuvo® and M5C5 are registered trademarks of Nidek Medical Products, Inc.

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Table of Contents
3-5
General Safety
Instructions Production and Use of Oxygen 6
Use and Maintenance of the Device 6
Standards and Regulations 6
Section 1.0
Introduction
1.1
Home Service Provider Responsibility 7
1.2
Important Notice and Symbol Explanations 8
1.3
Functional Specifications 9
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 Battery Test
2.3.2 Power Failure Alarm test
Oxygen Concentration Test and Specification
9
10
10
11
11
11
Section 3.
0
Patient Instructions
3.1
3.2 General Instructions Routine Maintenance by the Patient 12 12
3.2.1 Cleaning the Cabinet Air Filter
3.2.2 Checking the Alarm System Battery 12 13
Section 4.0
Home Service Provider Maintenance
4.1
Routine Maintenance 13
4.1.1 Cabinet Air Filter 13
4.1.2 Final Product Filter Replacement 13
4.1.3 Inlet Air Filter Replacement 14
4.1.4 Battery Replacement 14
4.1.5 Wick Replacement 14
4.1.6 Recording Maintenance 15
4.2
Cleaning and Infection Control 15
4.2.1 Preparing for New Patient Use 15
Section 5.0
Service
5.1
Components 16
5.2
Cabinet Removal 16
5.2.1 Removing Cabinet Back 16
5.2.2 Removing Cabinet Front 16
5.2.3 Removing Control Panel 16
5.2.4 Main Structure 16

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5.2.5 Caster Replacement 17
5.3
Compressor 17
5.3.1 Compressor Replacement 18
5.3.2 Capacitor Replacement 19
5.4
Process Control Valve 19
5.5
Sieve Bed Replacement 19
5.5.1 Sieve Bed Removal 20
5.5.2 Sieve Bed Installation 20
5.
6
Cabinet Fan Replacement 20
5.7
Circuit Board Replacement 21
5.7.1 Circuit Board Removal 21
5.7.2 Circuit Board Installation 22
5.8
Product Regulator Check and Setting 22
5.8.1 Product Regulator Cleaning or Rebuilding 22
5.9
Pressure Switch Replacement 23
5.10
Circuit Breaker Replacement 23
5.10.1 Circuit Breaker Removal 23
5.10.2 Circuit Breaker Installation 23
5.11
I/0 (ON/OFF) Power Switch Replacement 23
5.11.1 I/0 (ON/OFF) Power Switch Removal 23
5.11.2 I/0 (ON/OFF) Power Switch Installation 24
5.12
Buzzer Replacement 24
5.13
Hour Meter Replacement 24
5.14
Flow Meter Replacement 24
5.14.1 Flow Meter Removal 24
5.14.2 Flow Meter Installation 24
5.15
Power Cord Replacement 24
Section 6.0
Troubleshooting
6.1
Air Pressure Test (P1) 25
6.1.1 High Air Pressure 25
6.1.2 Low Air Pressure 26
6.2
Product Pressure Test (P2) 26
6.2.1 High Product Pressure 26
6.2.2 Low Product Pressure 27
6.3
General Troubleshooting 27
6.4
Troubleshooting Chart 28-32
6.5
Tool Kit and Pressure Test Gauge 33

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Appendices
Exploded
Drawings A1: Base Assembly A1.1: Base Assembly 34 35
A2: Main Structure Assembly – Front View 36
A3: Main Structure Assembly – Rear View 37
A4: Regulator Assembly 38
A5: Compressor Assembly
A5.1: Compressor Assembly 39 40
A6: Control Panel Assembly; OCSI Unit - Front 41
A7: Control Panel Assembly; OCSI Unit - Rear 42
A6.1: Control Panel Assembly; OCSI Unit - Front 43
A7.1: Control Panel Assembly; OCSI Unit - Rear 44
A8: Control Panel Assembly; Non OCSI Unit -
Front 45
A9: Control Panel Assembly; Non OCSI Unit –
Rear 46
A10: Air Tank Assembly 47
A10.1: Air Tank Assembly 48
A11: Front Cabinet Assembly 49
A11.1: Front Cabinet Assembly 50
A12: Rear Cabinet Assembly 51
A12: Rear Cabinet Assembly 52
A13: Module Assembly 53
Parts Listing
A14: Replacement Parts Listing 54-57
Maintenance
Record A15: Maintenance Log 58-59

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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 MARK5 NUVO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.
Do not use an extension cord or multiple sockets which can create sparks and
therefore pose a fire risk.
Use of the MARK5 NUVO 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 MARK5 Nuvo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,

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● 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.
1.0 Introduction
1.1 Home Service Provider Responsibility
All Home Service Providers of the Nidek Medical Mark5 Nuvo® Oxygen
Concentrator must assume responsibilities for handling, operational check-out,
patient instruction, and maintenance. These responsibilities are outlined below and
throughout this manual.
WARNING
Mark5 Nuvo 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 Mark5 Nuvo® 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 Mark5 Nuvo® 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 battery and power disconnect alarm as described in
Section 2.3 of this manual.

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● Deliver Mark5 Nuvo® units only to patients authorized by a physician’s
prescription. The Mark5 Nuvo® 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 Mark5 Nuvo® in conjunction with the
Patient 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 cabinet
air filter and how to check the alarm system battery. (Refer to Section
3.2.)
Be available to service each patient at any time. Maintain the Mark5
Nuvo® 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 Mark5 Nuvo® Oxygen Concentrators.
● Refer to the Mark5 Nuvo® 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.
The following harmonized symbols (pictograms), used for non-English language
countries, will be located on the exterior of the Mark5 Nuvo® unit:
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
accessories.
Indicates an alarm signal.

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Do not use any oil or grease on or near the device
1.3 Functional Specifications
Dimensions: 15.5 in. long, 15.6 in. wide, 27.8 in. tall
(394 mm long, 396 mm wide, 706 mm high)
Weight: 50 to 54 Ib (22.5 to 24.5 kg) depending on sound attenuation;
Electrical 120 VAC, 60 Hz, 4 amps, 410 watts
Requirements: 220 VAC, 50 Hz, 2 amps, 420 watts
Capacity: 5 liters per minute at 90% oxygen
(Based on 70°F [21°C] at sea level)
Accuracy: Flow meter ±5% full scale. (Based on pre-calibrated analysis.)
Concentration: 1 - 3 liters per minute at 95% + 0.5 / - 3%
4 liters per minute at 92% + 3.5 / - 3%
5 liters per minute at 90% + 5.5 / - 3%
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 Mark5 Nuvo® Oxygen Concentrator through an external cooling air
intake filter. This filtered air enters the compressor via a suction resonator 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 an air tank.
The heat exchanger reduces the temperature of the compressed air and the air tank
stores air when feed is interrupted. Next, a rotary poppet feed 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 four seconds
and delivers it to the product storage volume in the end of the column. Oxygen exits
the adsorbent column through a pressure regulator, flow control valve, flow meter,
and final product filter. The flow control valve, which is part of the flow meter,
controls the flow rate of oxygen delivered to the patient. The Mark5 Nuvo® unit

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delivers up to 95% oxygen concentration at flow rates from 1 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 Mark5
Nuvo® 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.
● Before plugging the unit into the wall outlet, actuate the I/0
(ON/OFF) switch to the I (ON) position and note that the audible
alarm sounds continuously. (See Section 2.3). Move the switch to
the 0 (OFF) position.
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 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).
3. Turn the flow meter adjustment knob counterclockwise until it stops
(wide open). The flow meter should register in excess of 5.5 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 Mark5 Nuvo® Oxygen Concentrator is equipped with a battery-powered alarm
system, which sounds a continuous and loud alarm when a power failure occurs or
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,