Nidek Mark 5 Plus User manual

CONTENTSCONTENTS

CONTENTS

CONTENTSCONTENTS

GENERAL SAFETY GUIDELINES ..................................... 1

I. DESCRIPTION..................................................................... 3

I. 1. Front panel (Fig. I. 1) ...................................................... 3

I. 2. Rear panel (Fig. I. 2) ......................................................... 3

II. STARTING-UP / INSTALLATION ................................ 3

II. 1. Use in direct oxygen therapy ......................................... 3

III. CLEANING - MAINTENANCE .................................... 4

III. 1. Cleaning .......................................................................... 4

III. 2. Everyday disinfection ................................................... 4

GENERAL SAFETY GUIDELINES

Only persons who have read and understood this entire manual should be allowed to operate the Mark 5 Plus.

USE OF OXYGEN

• Oxygen is not a flammable gas, but it accelerates the combustion of materials. To avoid all risks of fire, the Mark 5 Plus should be kept away from all flames, incandescent sources and sources of heat (cigarettes), as well as any combustible products such as oil, grease, solvents, aerosols, etc.

• Do not use in an explosive atmosphere.

• Avoid letting oxygen accumulate on an upholstered seat or other fabrics. In the event the concentrator is operating while not supplying oxygen to a patient, position it so that the gas flow is diluted in the ambient air.

• Place the device in a ventilated area free from smoke and atmospheric pollution (rear filter unobstructed).

USE AND MAINTENANCE OF THE DEVICE

• Use the power cord provided, and check that the electrical characteristics of the power socket used match those indicated on the manufacturer’s plate on the rear panel of the machine.

• We recommend avoiding the use of extension cords or adapters, as they are potential sources of sparks and fire.

• The MARK 5 Plus must only be used for oxygen therapy and only on medical prescription. The indicated daily duration and flow must be followed, otherwise it may present a risk to the health of the patient.

• Do not use in a specifically magnetic environment (MRI, etc.).

III. 3. Maintenance ................................................................... 4

IV. USEFUL INFORMATION .............................................. 4

IV. 1. Accessories and spare parts ........................................ 4

IV. 2. Materials in direct or indirect contact with the patient 4

IV. 3. Operating principles ..................................................... 4

IV. 4. Alarms - Safety devices ................................................ 5

IV. 5. Mark 5 Plus function .................................................... 5

IV. 6. Technical characteristics .............................................. 5

IV. 7. Standards ......................................................................... 6

IV. 8. Symbols - Abbreviations .............................................. 6

IV. 9. Method for disposing of waste ................................... 6

IV. 10. Method for disposing of device ................................ 6

IV. 12. Troubleshooting .......................................................... 7

•The Mark 5 Plus 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.

Conformity with IEC601-1 (§ 6.8.2 b):

"The manufacturer, assembler, installer or distributor are not considered to be responsible themselves for the consequences on the safety, reliability and characteristics of a device unless:

- The assembly, fitting, extensions, adjustments, modifications or repairs have been performed by persons authorized by the party in question,

- The electrical installation of the corresponding premises complies with IEC /NEC requirements.

- The device is used in accordance with the instructions for use." If the replacement parts used for the periodic servicing by an approved technician do not comply with the manufacturer’s specifications, the manufacturer is not responsible in the event of an accident.

•Do not open the device while in operation: risk of electrical shock. This device complies with the requirements of the FDA Quality System Regulation and the 93/42/EEC European directive but its operation may be affected by other devices being used near by, such as diathermy and high frequency electro-surgical equipment, defibrillators, short wave therapy equipment, mobile telephones, CB and other portable devices, microwave ovens, induction plates or even remote control toys or any other electromagnetic interferences which exceed the levels specified by the EN 60601-1-2 standard.

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AVAILABLE ACCESSORIES IF PRESCRIBED BY A PHYSICIAN

Humidifier: P / N 9012-8774 Cannula: P / N 9012-8780 Extension Tubing 25ft. (7.6m): P / N 9012-8781 Tubing Adapter P / N 9012-8783

The above items are available from Nidek Medical Products, Inc.

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I. DESCRIPTION

II. STARTING UP / INSTALLATION

The Mark 5 Plus is an oxygen concentrator designed to satisfy oxygen therapy prescriptions at home or in the clinic. It provides a continuous flow of oxygen enriched Product by separating the oxygen and nitrogen contained in ambient air. It can be used either to administer oxygen with nasal cannulas or another probe or mask type of device.

The Mark 5 Plus is easy to use. The single flow adjustment knob allows:

• the device to be easily adjusted to the prescribed flow rate,

• the equipment supplier or medical staff to limit flows to a specific range of flow rates with an internal locking device. It has a power failure alarm and an operating fault alarm.

Note: the performances described pertain to the use of the Mark 5 Plus with the accessories recommended by Nidek Medical Products, Inc.

Attention : Les performances peuvent être dégradées au delà de 4000 mètres. Dans ce cas veuillez consulter votre technicien pour un réglage précis.

I. 1. Front panel (Fig.

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I. 1)

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1 Start/stop (on/off) Rocker Switch

2 Humidifier (space reserved)

a) Flask

b) Lid

c) Outlet connector

3 Oxygen enriched air outlet

4 Flow adjustment knob (l/min.)

5 Safety instructions

6 Oxygen monitor (when installed).

II. 1. Use in direct oxygen therapy

a - Ensure that the switch (1) is in the 0/(OFF) position.

b - Turn the flow adjustment knob (4) to the prescribed value. This knob may have already been locked in the medically prescribed position. In this case, do not force it. Only the technician or medical personnel are authorized to release it.

c - If used with a humidifier: Unscrew the flask and fill it with water up to the line (see the

humidifier instructions). Then screw the humidifier flask onto its lid until there are no leaks from it.

d - Connect the oxygen tube to the humidifier outlet nozzle or to the

concentrator outlet if a humidifier has not been prescribed. The tube between the cannula and the Mark 5 Plus should be limited to 60 feet (20 meters) long, in order to ensure that the oxygen flow rate remains within specification values.

e - Ensure that all of the parts are connected correctly so as to avoid leaks.

f - Plug the power cable into a power outlet of correct voltage and frequency as defined on the manufacturer's label (8).

g - Press the switch to the start position I/ ON (LED lit). Units without OCSI will sound an alarm for a few seconds. Units with OCSI will suppress the green LED until oxygen concentration exceeds the set point.

h - Check that the oxygen flows out of the administration device (nasal cannulas or other) by placing the orifice(s) on the surface of a glass of water. The flow should disturb the surface of the water.

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I. 2. Rear panel (Fig.

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. 2)

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7 Dust filter

8 Manufacturer’s label

9 Electrical power cord

10 Hour meter (located under the dust filter)

11 Internal filter access panel (service provider)

i - Adjust the nasal cannulas or mask to suit your face.

Remark: the required oxygen concentration is normally obtained within five minutes after the unit is switched on.

At the end of the treatment, press the Rocker Switch (1) to place it in the O/(OFF) position to stop the device. The oxygen enriched air flow continues for approximately 1 minute after the device is stopped.

For the equipment supplier or medical staff:

The flow adjustment knob may be locked to limit it to a given range of values. (See procedure in the maintenance manual).

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