Nidek Nuvo Lite User manual (2018)

INSTRUCTIONS FOR USE

uvo

Lite

(Model

shown for reference.

Mark 5 Nuvo Lite Family

(Nuvo Lite and Nuvo Lite 3)

OXYGEN CONCENTRATOR

For models: 525, 535, 925 and 935

(and variants thereof)

[Original language is English]

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.

Contents

1 GLOSSARY OF SYMBOLS ................... 2

2 YOUR DEVICE ....................................... 2

2.1 Intended Use and Operation .............. 2

2.2 Device Features ................................. 2

2.3 Alarms and Safety Features............... 3

2.4 Device Performance and

Specifications ............................................... 3

2.5 Accessories and Spare Parts .............. 4

3 UNPACKING AND INSPECTION ......... 4

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 operate 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).

4 INSTALLATION AND OPERATION .... 4

4.1 Installation ......................................... 4

4.2 Start-Up ............................................. 5

4.3 Shut Down ......................................... 5

5 CLEANING AND MAINTENANCE ...... 5

5.1 Cleaning ............................................ 5

5.2 Maintenance ...................................... 5

6 DISPOSAL ............................................... 6

6.1 Method for Waste Disposal ............... 6

6.2 Disposing of the Device .................... 6

7 TROUBLESHOOTING ........................... 6

Federal Law (US) restricts this device to sale by, or on the order of, a licensed physician. This oxygen

℞Only

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concentrator should be used only under the supervision of a licensed physician.

8 EMC INFORMATION............................. 7

9 CONFORMITY WITH EN 60601-1 ........ 8

1 GLOSSARY OF SYMBOLS

To ensure your safety, u

only after one or more

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

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.

2.2 Device Features

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

2 YOUR DEVICE

2.1 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).

settings have been individually determined or prescribed for you at your specific activity levels – AND – only use the accessories that were used when your settings were determined.

While undergoing oxygen therapy, if you feel discomfort or experience a medical emergency, seek medical assistance immediately.

Front panel (Fig. 1)

1 – Flow adjustment knob 4 – Circuit Breaker 2 – Oxygen Product Outlet 5 – Indicator Lights 3 – Mains Power Switch (green and yellow)

Rear panel (Fig. 2)

6 – Humidfier (space reserved) 9 – Air Filter / Grill 7 – Technical Label 8 – Mains Cable 10 – Hour Meter

(Inlet Filter under – Fig 5)

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Use the power cord provided. Check that the electrical characteristics of the power outlet used match those indicated on the manufacturer’s technical label (Fig 2-7) 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.

2.3 Alarms and Safety Features

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.

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.

Test alarm by actuating the Power Switch (Fig 1-3) when



Oxygen Concentration Status Indicator: The oxygen

concentration monitor is an electronic module capable of checking the effective oxygen concentration supplied by the concentrator. The oxygen monitor measures the concentration and activates an audible and visual alarm if it falls below the alarm set point percentage. When the device is started, the indicator lights (Fig 1-5) located on the front panel operate as described below.

Green indicator: This light indicates that power is

applied to the concentrator and that it is ready to provide oxygen enriched air to the patient.



Yellow indicator: This light and a continuous audible

alarm will activate when the oxygen concentration level falls below the set point.

Devices manufactured prior to 2018 included a red indicator light.



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.

the mains cable is not plugged into the power outlet.

On initial power up, this indicator light will flash green until the device has reached normal operating conditions. This should happen within approximately 2 minutes.

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%.

If any of the above alarm conditions occur, press the Power Switch (Fig 1-3) to the “O” (OFF) position. Call your equipment supplier to service the device.

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 (Fig 1-2). This break will keep fire from entering the device.

2.4 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 525 925 535 935

Description

Frequency 60 Hz 50 Hz 60Hz 50 Hz

Average Power

Protection Class

Mains Protection

Average Oxygen Content

Liter Flow 0.125 to 5 LPM 0.125 to 3 LPM

Outlet Pressure

Dimensions (L x W x H)

Weight 14.5 kg (32 lbs.)*

Noise Level < 58 dBA

* Weight dependent on model and features

 

5 LPM

115V

330 Watts 300 Watts 210 Watts 180 Watts

10A 5A 5A 5A

87% to 95.5%

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.

Materials in direct or indirect contact with the patient

Concentrator enclosure ABS/Polycarbonate Printed labels Polycarbonate Power switch (Fig 1-3) Nylon Oxygen product outlet (Fig 1-2) SS, brass or aluminum

5 LPM

230V

At 2 LPM

> 90%

At 5 LPM

7 Psig 7 Psig

36 x 23 x 58.5 cm (14 x 9 x 23 in.)

3 LPM

115V

Class II

At 2 LPM

> 90%

At 3 LPM

87% to 95.5%

3 LPM

230V

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