Nidek Medical Mark 5 Nuvo M5C5 User manual

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User’s Guide
Mark 5 Nuvo
M5C5
Oxygen Concentrator
Manufactured by:
Nidek Medical Products, Inc.
BIRMINGHAM, ALABAMA, USA
Federal Law (US) restricts this device to sale by, or on the
order of, a licensed physician. Read and understand this
entire manual before using this device.
IMPORTANT SAFETY GUIDELINES 1 ACCESSORIES AND SPARE PARTS 2
DESCRIPTION / PURPOSE OF USE 1 ALARMS AND SAFETY DEVICES 3
START UP / INSTALLATION 2 SPECIFICATIONS 3
CLEANING / MAINTENANCE 2 TROUBLESHOOTING AND SYMBOLS 3
• If you are experiencing any signs of discomfort consult your Equipment Provider or your physician immediately.
• The unit should only be used for oxygen therapy and by medical prescription. The prescribed daily duration and flow rate must be
followed, otherwise it may present a risk to the health of the patient.
• Do not leave unit on or unattended if not in use by the patient.
• Do not use extension cords or adapters.
• Do not smoke, or allow others to smoke near the unit while in use.
• Do not use in a magnetic environment such as MRI, X-ray, etc.
• Do not remove the covers of the unit.
• Do not place unit where the intake filter ventilation could be obstructed or blocked.
• Oxygen is not a flammable gas, but accelerates the combustion of materials. To avoid all risks of fire, the unit must be kept away
from all flames, incandescent sources and sources of heat, as well as any combustible products such as oil, grease, solvents,
aerosols, etc.
• This device complies with the requirements of the FDA Quality System Regulation but its operation may be affected by other
devices being used near by.
GLOSSARY OF SYMBOLS
!ATTENTION DO NOT GREASE CLASS II DEVICE
DO NOT EXPOSE TO OPEN
FLAMES TYPE B DEVICE TECHNICAL INFORMATION
DO NOT SMOKE FRAGILE – HANDLE WITH CARE KEEP IN THE VERTIFICAL
POSITION
The Mark5 Nuvo M5C5 is intended solely for medical use in oxygen therapy programs under the supervision of a physician. This
device is available by prescription only and is not intended to support or sustain life. It produces oxygen enriched product by
concentrating the oxygen contained in room air. The prescribed daily duration and flow rate must be followed, otherwise it may
present a risk to the patient’s health.
TABLE OF CONTENTS
IMPORTANT SAFETY GUIDELINES
DESCRIPTION / PURPOSE OF USE

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Front Panel Illustration
1. Power Switch
2. Oxygen Outlet
3. Humidifier (space reserved)
4. Flow Adjustment Knob (l/min)
On Flowmeter
5. Circuit Breaker
6. Indicator Lights
7. Symbols
Rear Panel Illustration
8. External Cabinet Filter
9. Technical Label
10. Power Cord
1. Ensure that the Power Switch (1) is in the (0) Off position.
2. Position unit where the External Cabinet Filter (8) is not obstructed.
3. Plug the Power Cord (10) into a power outlet of the correct voltage and
frequency as defined on the Technical Label (9) located on the rear panel of
the machine.
4. Connect oxygen tubing to the oxygen outlet (2) connector. If a humidifier
has been prescribed, add water to the recommended level and attach the
humidifier to the oxygen outlet (3) then attach the oxygen tubing to the
humidifier outlet.
5. Press Power Switch to the (I) On position. The Red Indicator Light (6) will
illuminate and the audible alarm will sound until the system pressure rises to
the accepted level.
Note: The required oxygen concentration is normally obtained within
five minutes after the machine is turned on.
6. Turn the Flow Adjustment Knob (4) to the prescribed flow rate. The ball
inside the flowmeter (4) should be centered on the line indicating the flow
rate. View the flowmeter in a horizontal plane for accurate settings.
6. Place your nasal cannula or mask as instructed by your Equipment
Provider.
7. At the end of treatment, press the Power Switch (1) to the (0) Off position.
Note: The oxygen enriched air flow continues for approximately one
minute after the machine is turned off.
Note: Unplug the unit before performing maintenance or cleaning.
Only the outside of the unit is to be cleaned with a soft dry cloth or, if
necessary, a damp sponge with a mild soap. Do not use acetone, solvents,
abrasive powders or any inflammable products to clean the cabinet.
The removable External Cabinet Filter (8) must be cleaned weekly. More
frequent cleaning may be required in dusty environments. Clean filter by
washing in soapy water, rinsing thoroughly and allowing filter to air dry before
replacing.
Follow Manufacturer’s Instructions for the cleaning requirements of the
Humidifier (if prescribed) and oxygen tubing, etc.
Note: No additional maintenance is required or should be performed by
the patient. The Manufacturer’s Instructions for Preventative
Maintenance and Repair of the Device is defined in the Technical
Manual provided to your Equipment Provider.
The accessories and spare parts used with or for this unit must comply with
the general requirements of the FDA Quality System Regulation.
Note: The following accessories are recommended for use with this
unit.
9012-8774 Humidifier
9012-8777 Cannula Line Water Trap
9012-8778 Cannula with 15’ Tubing
9012-8780 Cannula with 7’ Tubing
9012-8781 25’ Tubing Extension
9012-8782 Supply Line Adapter
1
2
3
4
5
6 & 7
8
9
10
START UP / INSTALLATION
CLEANING / MAINTENANCE
A
CCESSORIES AND SPARE PARTS

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ALARMS / SAFETY DEVICES
•Power Failure Alarm – In the event of a loss of power, a continuous audible alarm is activated.
•Process Failure Alarm – In the event of a process failure, the Red Light Indicator (6) and audible alarm is activated.
•Electrical Protection Device – in the event of a surge or drop in the power supply the Circuit Breaker (5) will trip.
Restart the unit by depressing the reset button on the Circuit Breaker (5)
•Green Light Indicator (6) indicates that the unit has power and is ready to provide oxygen enriched air to the patient.
•Red Light Indicator (6) indicates that a system fault has occurred or there is no power to the unit.
SPECIFICATIONS
Flow Values: 0 to 5 Liters per Minute Characteristics: Electrical:
Length – 15.5” or 394 mm 120 VAC, 60 Hz, 4.0 amps, 400 watts
Average Oxygen Content: Width – 15.6” or 396 mm 230 VAC, 50-60Hz, 2.0 amps 400 watts
•at 2 Liters per Minute – 94% Height – 27.8” or 706 mm Two-Prong polarized plug
•at 4 Liters per Minute – 93% Weight – 49-51 lbs. or 22-23 kg. Double Insulated Cabinet
•at 5 Liters per Minute – 90% (Varies with models)
Storage Instructions: This device should only be stored, transported and operated in the vertical position.
Disposal of Device and Accessories: The unit and accessories (tubing, humidifier, etc.) should be disposed of using the methods
appropriate to the local waste authority where used.
TROUBLESHOOTING
OBSERVATIONS POSSIBLE CAUSES SOLUTIONS
The (I/0) Power Switch is in the (I) On
Position but the device does not operate.
The audible alarm sounds continuously
Power Cord (10) is not
plugged into outlet
Power failure
Check that the unit is properly plugged into the electrical outlet
Check the Circuit Breaker (5) and reset if necessary
Red Light Indicator (6) remains lit Product pressure or purity is
not at an acceptable level
Contact your Equipment Provider
The audible alarm does not sound when
unit is first turned on
Faulty 9 volt battery
Internal electrical fault
Contact your Equipment Provider
The unit is operating but the Green Light
Indicator (6) is not lit
Faulty indicator Contact your Equipment Provider
The unit is operating but there is no flow
(flowmeter ball not moving)
Internal system failure Stop device immediately and contact your Equipment Provider
The unit is operating but the audible alarm
sounds continuously
Internal fault Stop device immediately and contact your Equipment Provider
The unit suddenly stops and then starts
again in a few moments.
Dirty Filters
Compressor Thermal Shut-Off
Clean External Cabinet Filter (8)
Contact your Equipment Provider
The oxygen flow is interrupted or the flow
at the cannula feels irregular
Tubing is disconnected or not
tight
Tubing is restricted
Check tubing connections
Straighten tubing
Contact your Equipment Provider
NIDEK MEDICAL PRODUCTS, INC.
3949 VALLEY EAST INDUSTRIAL DRIVE
BIRMINGHAM, ALABAMA 35217 USA