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Nidek Medical Nuvo 10 - User Manual

Nidek Medical Nuvo 10
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______________________________________________________________________________________________________________
2010-2324CE-B September 2015 Page 1 of 12
USER'S GUIDE
Mark 5 Nuvo Family
NUVO, NUVO 8 & NUVO 10
OXYGEN CONCENTRATOR
[Original language is English]
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 of a licensed physician.
____________________________________________________________________________________
CONTENTS GLOSSARY OF SYMBOLS
WARNING
GLOSSARY OF SYMBOLS 1
1.GENERAL SAFETY GUIDELINES 2
1.1. Method for Waste Disposal 3
1.2. Method for Disposing of Device 3
2. Description 3
2.1. Front panel (Fig. 2. 1) 3
2.2. Rear panel (Fig. 2. 2) 3
3. STARTING-UP / INSTALLATION 3
3.1. Use in direct oxygen therapy 3
4. CLEANING-MAINTENANCE 4
4.1.Cleaning 4
4.2.Everyday disinfection 4
4.3.Maintenance 4
5.USEFUL INFORMATION 4
5.1.Accessories and spare parts 4
5.2.Materials in direct/indirect contact
with patient 5
5.3.Operating principles 5
5.4.Alarms - Safety devices 5
5.5.Indicators 5
5.6.Expected Life 6
5.7.Technical characteristics 6
5.8.Standards 7
5.9.Preventative Maintenance 7
5.10 Troubleshooting 8
6. EMC, Electromagnetic statements 9
: ON (Power Switched on)
: OFF (Power Switched off)
: Type B Device
: Class II Protection
: DO NOT EXPOSE TO OPEN FIRE
: DO NOT USE OIL OR GREASE
: Technical Information
: Consult the accompanying documents
: Keep in vertical position
: Fragile - Handle with care
: Oxygen concentration warning light
0413 Complies with the 93/42/EEC directive
certified by the approved organization 0413.
DANGER: Do not smoke when using
oxygen or when near this device.
NUVO 8
s
hown for reference
.

Other manuals for Nidek Medical Nuvo 10

Questions and Answers

Overview

The NIDEK Mark 5 Nuvo Family Oxygen Concentrator, including the Nuvo, Nuvo 8, and Nuvo 10 models, is a medical device designed to supply supplemental oxygen to individuals requiring oxygen therapy. It is not intended to be life-supporting or life-sustaining. This device produces an oxygen-enriched product by concentrating oxygen from room air and can be used with nasal cannulas or other administration devices. Federal Law (US) restricts its sale to, or on the order of, a licensed physician, and it should only be used under the supervision of a licensed physician.

Function Description:

The concentrator operates by drawing in filtered ambient air. A compressor then sends this air to an electronic valving system, which directs the compressed air to columns containing a molecular sieve. The molecular sieve adsorbs nitrogen, allowing oxygen to pass through. The oxygen-enriched product is then directed through a pressure-reducing valve to an adjustable flow meter and finally to the oxygen outlet fitting. While one column is in production (adsorbing nitrogen and producing oxygen), the other column undergoes a "regeneration" phase, desorbing nitrogen back into the ambient air. A bacterial filter is located prior to the oxygen outlet fitting to ensure product purity.

Important Technical Specifications:

  • Dimensions (L x W x H): 394 x 396 x 706 mm (15.5 x 15.6 x 27.8 in.)
  • Weight: 24 kg / 54 lbs
  • Caster Diameter: 50 mm (2.0 in.)
  • Tilt Angle (transport with humidifier fitted): 70°
  • Noise Level: Within ISO 8359 guidelines
  • Flow Values: Continuously adjustable flowmeter, with ranges of 1 to 5 lpm, 2 to 8 lpm, or 2 to 10 lpm, depending on the model.
  • Flow Accuracy: Equal to the flow set on the flowmeter, accurate to within ± 10% or 200 ml/min, whichever is larger.
  • Average Oxygen Content (at 21°C and one atmosphere pressure):
    • 2 lpm: > 90%
    • 5 lpm, 8 lpm, 10 lpm: 87% to 95.5%
  • Minimum Recommended Flow: 1 lpm on Nuvo unit, 2 lpm on Nuvo 8 & 10 units.
  • Maximum Recommended Flow: 5 lpm on Nuvo, 8 lpm on Nuvo 8, and 10 lpm on Nuvo 10 model specific.
  • Maximum Outlet Pressure: 7 psig for Nuvo 5 lpm, 15 psig for Nuvo 8 lpm, and 17 psig for Nuvo 10 lpm.
  • Electrical Power Supply (Model Dependent):
    • 5 lpm 115V 60Hz: 410 Watts, Class II, 10A Mains Protection
    • 5 lpm 230V 50/60Hz: 420 Watts, Class II, 5A Mains Protection
    • 8 lpm 115V 60Hz: 500 Watts, Class II, 10A Mains Protection
    • 8 lpm 230V 50Hz: 490 Watts, Class II, 5A Mains Protection
    • 10 lpm 115V 60Hz: 700 Watts, Class II, 10A Mains Protection
    • 10 lpm 230V 50Hz: 600 Watts, Class II, 5A Mains Protection
  • Circuit Breaker: 5A for 230V models, 10A for 115V models.
  • Safety Valve: Calibrated to 3.4 bar (50 psig) on the compressor outlet.
  • Expected Service Life: 15,000 hours or 3 years.
  • Environmental Conditions:
    • Operation Temperature: 10°C to 40°C (50°F to 105°F)
    • Storage Temperature: -20°C to 60°C (0°F to 140°F)
    • Relative Humidity: 15% to 95% (non-condensing) for operation and storage.
    • Altitude: Up to 1500m (5000ft) without degradation.

Usage Features:

  • Easy Adjustment: A single flow adjustment knob allows for easy adjustment to the prescribed flow rate. This knob can be locked by equipment suppliers or medical staff to limit flows to a specific rate.
  • Power Switch (I/O): Used to turn the device ON ("I") or OFF ("O").
  • OCSI (Oxygen Concentration Status Indicator): Indicator lights on the front panel provide visual feedback on oxygen concentration. A green light indicates power is applied and oxygen-enriched air is being provided at the set point. A red light indicates a system fault, such as low oxygen concentration or a blocked cannula/hose.
  • Audible Alarms: The device features an audible alarm for power loss, low oxygen concentration, and blocked cannula/hose. The user must ensure the alarm can be heard within their environment.
  • Humidifier Compatibility: Designed to be used with a humidifier (if prescribed), with a dedicated space reserved on the front panel.
  • Polarized Plug: May be equipped with a polarized plug for safety.
  • Warm-up Time: After turning off, users must wait 3-5 minutes before restarting to allow system pressure to dissipate.

Maintenance Features:

  • Cabinet Air Filter (7): Removable and located on the rear panel. Must be cleaned weekly in warm water with household detergent or after approximately 100 hours of use. More frequent cleaning is recommended in dusty environments.
  • Inlet Air Filter (11): Located behind the cabinet air filter. Should be inspected at each patient visit and replaced annually, or more often depending on the environment.
  • Final Product Filter: Located before the oxygen outlet (technician-only maintenance).
  • Humidifier Disinfection: If prescribed, the humidifier flask should be emptied daily, rinsed with running water, and refilled with distilled water. Regularly disinfect humidifier parts by immersing them in a solution (e.g., 1 part vinegar diluted with 10 parts water), then rinse and dry. Check the humidifier lid seal condition.
  • Oxygen Tubing and Nasal Cannula: Follow manufacturer's instructions for cleaning and replacement. For new patients, the entire oxygen administration circuit (including nasal cannulas) must be changed.
  • Periodic Maintenance: No special patient maintenance is required beyond filter cleaning and humidifier care. Equipment suppliers perform periodic maintenance operations, including checking oxygen concentration every 15,000 hours or 3 years to verify OCSI function.
  • Troubleshooting Guide: The manual provides a troubleshooting section for common issues like the device not operating, alarms, or irregular flow.
  • Service Manual: Detailed preventive maintenance instructions are defined in the service manual (part ref: 2010-2329 NUVO Family Service Manual) and should be performed by suitably trained technicians certified by the manufacturer, using original spare parts.
  • Maintenance Log: Users are advised to record all maintenance activity in the Maintenance Log found in the service manual and online at www.nidekmedical.com.

Safety Information:

  • Oxygen accelerates combustion; keep the device away from flames, heat sources, smoking materials, oil, grease, solvents, and aerosols.
  • Avoid oxygen accumulation on upholstery or bedding.
  • Ensure proper patient connection to avoid injury, including strangulation.
  • No modifications to the equipment are allowed.
  • Use only accessories recommended by Nidek Medical Products, Inc.
  • Do not disassemble due to electrical shock.
  • Use the provided power cord and ensure electrical characteristics match the power socket. Avoid extension cords and adapters.
  • Do not use in magnetic environments (MRI, X-ray).
  • The device complies with the 93/42/EEC directive and is certified by the approved organization 0413.

Nidek Medical Nuvo 10 Specifications

General IconGeneral
BrandNidek Medical
ModelNuvo 10
CategoryMedical Equipment
LanguageEnglish

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