Nidek Medical Max 30 3005 User manual

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2010-9801CE-D March 2022 Page 1 of 8
EN
INSTRUCTIONS FOR USE
Max 30
OXYGEN CONCENTRATOR
For models: 3005 and 3010
(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.
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).
℞Only
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
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
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
8 EMC INFORMATION............................. 7
9 CONFORMITY WITH EN 60601-1 ........ 8

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2010-9801CE-D March 2022 Page 2 of 8
Figure 1
Figure 2
1 GLOSSARY OF SYMBOLS
ON (Power switched on)
OFF (Power switched off)
Manufacturer Name and Address
Type B Device
Class I Electrical Protection
IPX1 Protection from vertically falling water drops
Do Not Smoke
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
FRAGILE – Handle with Care
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 Max 30 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).
To ensure y
our safety, use
only after one or more
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.
The Max 30 concentrators begin 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 finally passes thru a booster pump
to increase the pressure to 50psi (3.4bar) and exits the
device through a fire resistant outlet. The product gas is
delivered to the patient and absorbed by tissues within
the nose, lungs and the pathway between the two.
2.2 Device Features
Front panel (Fig. 1)
1 – Start Button
2 – Stop Button
3 – Home Button
4 – Process Button
5 – Flow Meters
Rear panel (Fig. 2)
6 – Circuit Breakers
7 – Mains Switch
8 – Hour Meters (x 2)
9 – Cabinet Air Fitler (x 3)
10 – Mains Power Supply
11 – Manufacturer’s
Technical Label
12 – Alarm Battery (9V)
Panel Display
(Home Screen)
Figure 3
Panel Display
(Process Screen)
Figure 4

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2010-9801CE-D March 2022 Page 3 of 8
EN
Use the power cord provided.
Check that the electrical characteristics of the power
outlet used match those indicated on the manufacturer’s
plate 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, a continuous audible alarm is activated. The
display will remain off.

Test alarm by actuating the Mains Switch (Fig 2-7) when
the mains power supply is not plugged into the wall
receptacle. Periodically check to alarm to make sure the
9V alarm battery is working properly.
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 display located on the front panel
will show the oxygen concentration percentage.
Green headings: The display panel will show the
oxygen concentration and pressure headings in red until
the set points are reached. When all headings are green,
the device is ready to provide oxygen enriched air to the
patient.
Yellow headings: The Home and Process screens (Figs
3 and 4) will show yellow headings if something is
operating outside of normal conditions.
If any of the above alarm conditions occur, press the
Power Switch (Fig 2-7) to the “O” (OFF) position.
Call your equipment supplier to service the device.

On initial power up, O2 header bar will remain yellow
until the device has reached normal operating conditions
and then will turn green (within approximately 5
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 87% ± 3%.
The HOME (Fig 3) screen shows the following: outlet
pressure LOW / OK, concentration LOW / OK, and
temperature OK / HIGH.
The PROCESS (Fig 4) screen shows the following:
cabinet temperature OK / HIGH, low pressure
permissive, low pressure acceptable, low pressure above
minimum, high pressure demand, high pressure OK, low
oxygen concentration and high temperature.
Thermal safety: The compressor motors (4) are
protected by a thermal switch situated in the stator
winding (145 ± 5° C).
Electrical protection:
 A 15A circuit breaker is incorporated into the back
cabinet of all models
 Five (5) 5A circuit breakers are incorporated into the
device for each compressor and the control board.
 Class I device protection (EN60601-1 standard)
Safety valve: Device is fitted on the low pressure
compressor outlet and is calibrated to 3.4 bar (50 psig). It
is also fitted with a safety valve on the high-pressure
compressor outlet that is calibrated to 7.0 bar (115 psig).
Fire Break: This device is fitted with a metal fire break
at the Oxygen Product Outlet (Fig 1-3). This break will
keep fire from entering the device. See “Accessories and
Spare Parts” (§ 2.5) for fire safe accessories.
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 3005 3010
Description 30 LPM
230V
30 LPM
230V
Frequency 50 Hz 60Hz
Average Power 2100 Watts 2000 Watts
Protection Class Class I
Mains Protection 15A
Average Oxygen Content At 2 LPM: > 90%
Average Oxygen Content At 30 LPM: 87% to 95.5%
Liter Flow Minimum: 2 LPM (outlets combined)
Maximum: 30 LPM (outlets combined)
Outlet Pressure Maximum: 50 psig (3.4 bar)
Dimensions
(L x W x H)
530 x 610 x 1120 mm
(21 x 24 x 44 in.)
Weight 113 kg (250 lbs)
Noise Level Within 80601-2-69:2016 guidelines

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
Aluminum / Kyde
x
Printed
labels
Polycarbonate
Mains
switch (Fig
2
-
7
)
Nylon
Oxygen Outl
ets
/ Cabinet Screws
SS
/
Brass
Cabinet air filter
(Fig
2
-
9
)
Polyester
Mains cable
(Fig
2
-
9
)
PVC

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2010-9801CE-D March 2022 Page 4 of 8
Humidifier - Figure 5
Cannula
-
Figure
6
Inlet Filters
Polypropylene
Humidifier
Polypropylene
Casters
Poly
urethan
e
Pipe/Tubing Aluminum, PVC,
polyurethane and/or
silicone
, copper
2.5 Accessories and Spare Parts
The accessories used with the device must be oxygen
compatible, designed for oxygen therapy use,
biocompatible and comply with the general requirements
of the FDA Quality System Regulation or the 93/42/EEC
European Directive, or any other applicable regulatory
requirements.
The accessories below, available from Nidek Medical
Products, Inc. and our distributors, comply with these
requirements. Contact your equipment supplier to obtain
these accessories.
Accessories Part Ref
High Flow Humidifier (6 to 15 LPM) 9251-8774
High Flow Cannula with 2m (7ft) tubing
(2 to 10 LPM)
9251-8780
Extension Tubing 7.7m (25 ft) 9012-8781
Tubing Adapter 9012-8783
Flow Meter 9800-1047A
Fire Safe Valve 9800-8779
Fire Safe Nozzle 9800-8777
Petroleum and oil based lubricants, lotions and cosmetics
are flammable and the use of them while operating the
device is hazardous.
Improper patient connection to and us
e of the cannula
may result in injury, including strangulation. To reduce the
risk of this occurring, avoid situations that might cause the
cannula or hose to become entangled about the patient’s
neck and do not attach more than 15.5m (50 ft) in length
of tubing.
Ears, nose and neck may become irritated after prolonged
exposure to the cannula. For relief, only a water based
lubricant is recommended.
Nasal passages may become irritated after prolonged
exposure to the product gas. If this occurs, consult your
physician about using a humidifier during treatment.
The use of certain administration accessories and/or spare
parts which are not recommended by the manufacturer
may reduce its performance and void the manufacturer’s
responsibility.
Spare Parts Part Ref
Cabinet air filter (Fig 2-9) 9600-1053
Inlet Air Filters 9800-1027
Flow Meter (0 to 15 LPM) 9800-1047
9V Battery 7206-0027
Please consult the Max 30 Installation and Maintenance
Manual (PN 2010-9800) for instructions on replacing any
of the above spare parts.
3 UNPACKING AND INSPECTION
The Oxygen Concentrator is packaged to protect the
device 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.
If you do not plan to use your device immediately, please
consult the Environmental Storage Conditions below.
Environmental Storage Conditions:
The device should be stored in a dry area, with an
ambient temperature between -20°C to 60°C (0°F to
140°F) at 15-95% relative humidity. It must be stored,
transported and used in the vertical position only.
Oxygen concentration can be affected after prolonged
periods of storage – check device before use.
4 INSTALLATION AND OPERATION
4.1 Installation
Environmental Operating Conditions:
The device should be operated in a dry area, with an
ambient temperature between 10°C to 40°C (50°F to
105°F) at 15-95% relative humidity. The device can be
operated at an altitude of up to 1500m (5000ft) at a
temperature of 21°C (70°F) without causing product
degradation.
DO NOT use in explosive atmosphere.
To avoid risk of fire and explosion the concentrator should
be kept away from heat sources, incandescent sources,
solvents, Aerosols, etc.
Unit should be placed and operated in a well-ventilated
space that is free of pollutants or fumes and protected
from the elements with adequate lighting.
Unit should be placed and operated in a space where the
position and storage of the mains cable (Fig 2-10) and
oxygen tubing do not present a tripping hazard. The
mains cable should be easily accessible for disconnection.
For patient safety and benefit, no modification to the
equipment is allowed. It is also not recommended to
interconnect the device with any equipment or
accessories not specified in this guide.
Device must have power to operate. In the event of power
loss and for continued operation a backup source is
recommended.
Do not use in a specifically magnetic environment (MRI, X-
ray, etc.). May cause device malfunction.

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2010-9801CE-D March 2022 Page 5 of 8
EN
We recommend against the use of extension cords and
adapters, as they are potential sources of sparks and fire.

Consult your equipment provider for further information
regarding altitudes of 1500 m to 4000m (5000 to 13000ft).

Complies with
EN 60529:2001 + A2:2014
rating of
IPX1
;
enclosure protects internal electrical components against
vertically falling water drops.
Complies with EN 60601-1:2006 [11.6.3]; enclosure
protects internal electrical components against spilling of a
glass of water (i.e. contents of humidifier).
4.2 Start-Up
1) Ensure that the Mains Switch (Fig 2-7) is in the “O”
(OFF) position.
If used with a humidifier (Fig 5): Unscrew the flask
and fill it with distilled water up to the line (see
manufacturer’s instructions). Then screw the lid on
the humidifier flask until there are no leaks. Connect
the oxygen tube to the humidifier outlet nozzle.
Screw the humidifier directly to the Flow Meter (Fig
1-5). Ensure that all of the parts are connected
correctly so as to avoid leaks.

Replace water in humidifier bottle before each
treatment.
If not using a humidifier: Connect the oxygen tube to
one of the Flow Meters (Fig 1-5).
2) Plug the Mains Power Supply (Fig 2-10) into a power
outlet of the correct voltage and frequency as defined
on the manufacturer’s technical label (Fig 2-11).
3) Press the Mains Switch (Fig 2-7) to the ON “I”
position. Press the START button (Fig. 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.

The required oxygen concentration is normally
obtained within five minutes after the device is
started.

See the Alarms and Safety Features on page 3 for
panel display colors and meanings.
4) Adjust the Flow Meter (Fig 1-5) to the prescribed
value.

View the flowmeter from straight on for accurate
settings.
5) 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.
6) Adjust the nasal cannula to suit your face.
4.3 Shut Down
At the end of the treatment, press the Stop Button (Fig.
1-2) to shut the device down. If the device will not be
restarted, then place the Mains Switch (Fig. 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.
Make sure during
operation a
nd after shu
t down
that
the cannula is facing away from soft surfaces and
clothing. Excess oxygen can accumulate and cause
ignition if exposed to a spark or open flame.

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.
5 CLEANING AND MAINTENANCE
5.1 Cleaning
Cleaning and your device: Visually check the outside of
the device periodically. To clean the enclosure, make
sure the Mains Switch (Fig 2-7) is in the "O" (OFF)
position, then use a soft, dry cloth or a damp sponge, to
wipe the cabinet enclosure until clean and to prevent
dust and dirt from building up on the device. Allow to
dry thoroughly before operation.

Acetone, solvents or any other flammable products must
not be used. Do not use abrasive powders.
Cleaning and replacing filters: The removable cabinet
air filters (Fig 2-9) can be found on the back and each
side of the device. They must be cleaned in warm water
and household detergent. Dry before reinstalling. The
Air Inlet Filters and the final product filter (not pictured)
should only be replaced by a technician if required.
Cleaning and replacing accessories: Clean the
humidifier according to manufacturer’s instructions. If
no instructions are provided, do the following: empty the
water from the humidifier, rinse the flask and lid under
running water. Regularly disinfect the humidifier by
immersing the flask and lid in a disinfectant solution (we
recommend using a solution of 1 part vinegar to 10 parts
water). Rinse under running water and dry. Tubing and
cannula should be used according to the manufacturer’s
instructions and replaced for each new patient to prevent
the spreading of bacteria and viruses.
5.2 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.
DO NOT disassemble due to danger of electrical shock.
Refer servicing to qualified service personnel.
The expected service life of this device is 10 years with
routine preventive maintenance.

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2010-9801CE-D March 2022 Page 6 of 8
Preventive Maintenance: Wash the cabinet filters (3)
weekly or after approximately 100 hours of use and for
each new patient. More frequent cleaning is
recommended in dusty environments. Inspect inlet air
filters (3) during each service. Replace filter annually, or
more often depending on environment. Check oxygen
concentration every 15,000 hours or 3 years to verify the
continuing OCSI function. Periodically check the 9V
battery to ensure the proper operation of the power loss
alarm.
The manufacturer’s instructions for the preventive
maintenance of the devices are defined in the service
manual, (Ref. 2010-9800). Check with your service
provider for any updates to recommended schedules. The
work must be carried out by suitably trained technicians
certified by the manufacturer. Use original spare parts
only (see “Accessories and Spare Parts”). Upon request,
the supplier can provide circuit diagrams, spare parts
lists, technical details or any other information of use to
qualified technical personnel for parts of the device
which are designated as being the manufacturer’s
responsibility or by the manufacturer as repairable.
6 DISPOSAL
6.1 Method for Waste Disposal
All waste from the device (Patient Circuit, Molecular
Sieve, Filters, Etc.) must be disposed of using methods
appropriate to the civil authority of the location where
disposed.
6.2 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.
7 TROUBLESHOOTING
Observations Possible Causes Solutions
The I-O (ON/OFF) button is in the “I” (ON)
position but the device does not operate.
Mains Power cable (Fig. 2.2-10)
is not correctly plugged into the
wall outlet.
Check the cable connection.
The alarm test does not work.
(See Section 5.4.1 in this User’s Guide)
9V Battery is dead
Internal electrical fault.
Replace 9V battery and retest.
Contact your equipment supplier.
The I-O (ON/OFF) button is in the “I” (ON)
position, the compressor is operating and there is
a flow but the green light is not lighted.
Faulty indicator. Contact your equipment supplier.
The I-O (ON/OFF) button is in the “I” (ON)
position but there is no flow. The audible alarm
sounds continuously.
Pneumatic connection broken or
other pressure problem.
Stop the device by pressing the I-O
(ON/OFF) button.
Contact your equipment supplier.
The I-O (ON/OFF) button is in the “I” (ON)
position, the compressor is operating and there is
a flow but the audible alarm sounds
continuously.
Internal electrical fault.
Pneumatic circuit fault or low
purity.
Stop the device by pressing the I-O
(ON/OFF) button.
Contact your equipment supplier.
The compressor stops in mid-cycle, then starts
again after a few minutes.
Compressor thermal safety
device has been activated.
Dirty Filters.
Fan is not working.
Stop the device by pressing the I-O
(ON/OFF) button and wait for it to cool
down.
Clean cabinet filter. Restart.
If the device does not start, contact your
equipment supplier.
The oxy
gen enriched air flow is interrupted at the
nasal cannula outlet.
Tube disconnected or humidifier
cap is not tight.
Check that tubing connections are secure
and that the humidifier is sealed.
The flow at the nasal cannula outlet is irregular. Cannula tubing is kinked or
restricted.
Straighten the tubing; contact your
equipment supplier if damaged.

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2010-9801CE-D March 2022 Page 7 of 8
EN
8 EMC
INFORMATION

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2010-9801CE-D March 2022 Page 8 of 8
9 CONFORMITY WITH EN 60601-1
CONFORMITY WITH EN 60601-1 (§ 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.
 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.
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 nearby, 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.
EU Representative
mdi Europa GmbH
Langenhagener Str. 71
30855 Hannover-Langenhagen
Germany
Tel: [phone]
Fax: [phone]
[e-mail]
www.mdi-europa.com
Nidek Medical Products, Inc.
3949 Valley East Industrial Drive
Birmingham, Alabama 35217 U.S.A.
Tel: [phone] Fax: [phone]
UK Responsible Person
Qserve Group UK, Ltd
49 Greek Street
W1D 4EG London
United Kingdom
Tel: [phone]
[e-mail]
www.qservegroup.com