Nidek Max 30 User manual (2017)

USER'S GUIDE

The MAX Family

MAX 30 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

WARNING

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under the supervision of a licensed physician.

CONTENTS GLOSSARY OF SYMBOLS _____

GLOSSARY OF SYMBOLS 1

1. GENERAL SAFETY GUIDELINES 2

1.1 Method for Waste Disposal 3

1.2 Method for Disposing of the 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 or indirect contact
with patient 5

5.3 Operating principles 5

5.4 Alarms - Safety devices 5

5.5 Indicators 6

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

DANGER: Do not smoke when using
oxygen or when near this device.

ON (Mains Power switched on)

OFF (Mains Power switched off)

Type B Device

Class I Electrical Protection

DO NOT EXPOSE TO OPEN FIRE

DO NOT USE OIL OR GREASE

Technical Information

Consult the accompanying documents

Keep in a vertical position

Fragile – Handle with care

QMS certified to Annex II of 93/42/EEC by
the approved organization 0413

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1. GENERAL SAFETY GUIDELINES
Only persons who have read and understood this entire manual should be allowed to operate the Max 30 Oxygen
Concentrator (hereafter known as the device).

The WARNINGS below indicate a potentially hazardous situation. If conditions are not avoided a situation
could occur that results in serious injury or death.

• Oxygen is not a flammable gas, but it accelerates the combustion of materials. Do not use in explosive
atmosphere. To avoid risk of fire and explosion the concentrator should be kept away from Flames, Heat
sources, Incandescent sources, Smoking Materials, Matches, Oil, Grease, Solvents, Aerosols, etc. Do not allow
oxygen to accumulate on upholstery or other fabric such as bedding or personal clothing. If concentrator is
operating while not connected to patient, position cannula so that the gas flow is diluted in the ambient air.

• Improper patient connection to and use of the cannula may result in injury including strangulation. Avoid
situations that might cause the cannula or hose to become entangled about the patient’s neck. Additional
monitoring is required for patients unable to communicate discomfort.

• Use of other accessories not described in this User's Guide are not recommended. Patient benefit may be
diminished. Do not lubricate any fittings associated with accessories.

• No modification to the equipment is allowed. To do so may affect patient benefit.

• 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).

• Device must have power to operate. In the event of power loss and for continued operation a backup source is
recommended.

• DO NOT disassemble due to danger of electrical shock. Refer servicing to qualified service personnel.

• To avoid the risk of electric shock, this equipment must only be connected to a supply mains with protective

earth. If not available, contact a qualified electrician. Do not defeat this safety feature.

The CAUTIONS below indicate a potentially hazardous situation. If conditions are not avoided a situation could
occur that results in property damage or minor injury or both.

• Use the power cord provided, and check that the electrical characteristics of the power socket used match those

CCONFORMITY WITH IEC60601-1:2005

(3RD EDITION)
“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:

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 or non-performance.
This device complies with the requirements of the FDA Quality System Regulation and 93/42/EEC European directive but
its operation may be affected by other devices being used near by, such as diathermy and high frequency electrosurgical
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.

indicated on the manufacturer’s plate on the rear panel of the device.

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

• 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.

• The device must only be used for oxygen therapy and only on a medical prescription. The indicated daily
duration and flow must be followed, otherwise it may present a risk to the health of the patient. If the patient
should feel any discomfort, they should consult the physician or respiratory technician.

• Do not position device so that it is difficult to access the mains power cord, so that it accessible for disconnect.

• Do not use in a specifically magnetic environment (MRI, X-ray, etc.). May cause device malfunction.

• Note: Medical Device Regulations require users and service providers to report to the manufacturer any incident

that could, if repeated, result in injury to any person.

• Assembly, fitting, extensions, adjustments, modifications or repairs have been performed by persons authorized
by the party in question.

• Electrical installation of the corresponding premises complies with local electrical codes. (e.g. IEC/NEC)

• Device is used in accordance with the instructions for use.

UNPACKING and PACKAGING

The device is packaged to protect it from damage while being transported and stored. After the device is removed from the
package, inspect for damage. If damage is detected, please contact your equipment provider. Operating environmental
condition guidelines are discussed later in Section 5.7 of this User’s Guide.

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1.1 Method for Waste Disposal

All waste from the device (Patient Circuit, Filters, Etc.) must be disposed of using methods appropriate to the civil authority
of the location where disposed.

1.2 Method for Disposing of the Device

This device has been supplied by an environmentally aware manufacturer. A majority of the parts in the device are
recyclable.
Follow local governing ordinances and recycling plans regarding disposal of the device or components normally used in
operation. Any accessories not original to the device must be disposed of in accordance with the individual product
markings for disposal. Furthermore, as part of the marking directive 93/42/EEC, the serial number of the device disposed of

must be sent to Nidek Medical if the unit has the marking.

2. DESCRIPTION

The device is intended to supply supplemental oxygen to persons requiring oxygen therapy. It is not intended to be life
supporting or life sustaining. It produces an oxygen enriched product by concentrating the oxygen contained in room air. It
can be used to administer oxygen with nasal cannulas or another type of device.
Note: the performances described pertain to the use of the device with accessories recommended by Nidek Medical

Products, Inc. Refer to section 5.1.

2.1 Front panel (Fig. 2.1)

1. Start Button

2. Stop Button

3. Home Button

4. Utility Button

5. Flow Meters

2.2 Rear panel (Fig. 2.2)

6. Circuit Breakers

Figure 2.1

7. Mains Switch

8. Hour Meters (x 2)

9. Cabinet Air Filter (x 3)

10. Mains Power Supply

11. Manufacturer's Technical Label

12. Alarm Battery (9V)

Figure 2.2

3. STARTING UP / INSTALLATION

3.1 Use in direct oxygen therapy

a. Ensure that the Mains Switch (Fig. 2.2–7) is in the “O” (OFF) position.
b. Connect the oxygen tube to one of the Flow Meters (Fig. 2.1-5)

• If used with a high flow humidifier bottle:

• Unscrew the flask and fill it with distilled water up to the line. Then screw the lid on

the humidifier flask until there are no leaks.

• Connect the oxygen tube to the humidifier outlet nozzle. The tube between the
cannula and the device should be limited to 20 meters (60 feet) long in order to ensure that the oxygen
flow rate remains within specification values.

• Ensure that all of the parts are connected correctly so as to avoid leaks

• Connect humidifier bottle directly to the flow meter.

c. Plug the Mains Power Supply (Fig. 2.2-10) into a power outlet of the correct voltage and

frequency as defined on the manufacturer's technical label (Fig. 2.2-11).

d. Turn the Mains Switch (Fig. 2.2-7) to the “I” (ON) position. Press the START button (Fig. 2.1-

1) on the front of the display panel. The panel displays will remain red until the oxygen
concentration exceeds the set point. Once the set point is reached, the displays will turn green

and indicate the concentration on the display panel. (See section 5.5 Indicators for further information)
Note: the required oxygen concentration is normally obtained within five minutes after the unit is started.
e. Adjust the Flow Meter (Fig. 2.1-5) to the prescribed value.
Note: View the Flow Meter from straight on for accurate settings.

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f. 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.
g. Adjust the nasal cannula to suit your face.
h. At the end of the treatment, press the Stop Button (Fig. 2.1-2) to shut the device down. If the

device will not be restarted, then place the Mains Switch (Fig. 2.2-7) in the “O” (OFF) position to

shut the device down. The oxygen enriched air flow continues for approximately one minute after

the device is stopped.
Note: After turning the unit off, the user must wait 5-10 minutes before turning it back on. System pressure

must dissipate before the unit will properly restart.

4. CLEANING - MAINTENANCE

4.1 Cleaning

Only the outside of the device is to be cleaned, with a soft, dry cloth or, if necessary, a damp sponge, then thoroughly dried
with wipes and an alcohol based solution. Acetone, solvents or any other inflammable products must not be used. Do not
use abrasive powders.
The removable cabinet air filters (Fig. 2.2-9) are located on each side and on the back of the machine. Each must be cleaned
in warm water and household detergent weekly or after approximately 100 hours of use. More frequent cleaning is
recommended in dusty environments. Dry before reinstalling.

4.2. Daily disinfection

Because there is a final product filter inside the device, daily disinfection concerns only the external oxygen therapy
accessories: humidifier bottles and nasal cannulas (refer to the respective instructions for use).

The device must be switched off when alcohol based solutions are used.
a. The following minimum guidelines must be observed:

Humidifier: (If prescribed by a physician)

Clean according to the manufacturer's instructions. If no instructions are provided, do the following:

Daily:

• Empty the water from the humidifier.

• Rinse the humidifier flask under running water.

• Fill humidifier up to the mark with distilled water.

Regularly:

• Disinfect the humidifier parts by immersing them in a disinfectant solution (In general, we recommend using a
solution of 1 part vinegar diluted with 10 parts water).

• Rinse and dry.

• Check that the humidifier lid seal is in good condition.

Oxygen tubing and nasal cannula: Follow the manufacturer’s instructions.

b. For each new patient:

Follow the instructions from the humidifier manufacturer. The device must be cleaned and disinfected as per the above
instructions. The cabinet air filters (Fig. 2.2-9) should be washed or replaced. The entire oxygen administration circuit
(oxygen therapy nasal cannulas, etc.) must be changed.

4.3 Maintenance

No special maintenance needs to be carried out by the patient. Your equipment supplier performs periodic maintenance

operations to assure continued reliable service from the device.

5. USEFUL INFORMATION

5.1 Accessories and spare parts

The accessories used with the device must:

• be oxygen compatible,

• be biocompatible,

• Comply with the general requirements of the FDA Quality System Regulation or the 93/42/EEC European

Directive as appropriate.

The connectors, tubes, nasal cannulas, or masks must be designed for oxygen therapy usage.
The accessories with a Nidek Medical part number reference, or included in the set of accessories supplied with the device,
comply with these requirements. Contact your equipment supplier to obtain these accessories.

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