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USER'S GUIDE
Mark 5 Nuvo(Std)
Lite
OXYGEN CONCENTRATOR
[Original language is English]
Federal Law (US) restricts this device to sale
or use by, or on the order of, a licensed physician. This oxygen concentrator should be
used only under the supervision of a licensed
physician.
Contents
Danger: Do not smoke when using oxygen or when
near this device
.
GLOSSARY OF SYMBOLS.......................................... 1
GENERAL SAFETY GUIDELINES ............................ 2
1 Unpacking and Packaging.......................................3
1.1 Method for disposing of waste.................................3
1.2 Method for disposing of device................................3
2 DESCRIPTION.......................................................3
2.1 F
2.2 Rear panel (Fig. 2.2) .............................................. 4
3 STARTING-UP / INSTALLATION .......................4
3.1 Use in direct oxygen therapy ...................................4
3.2 Turning off device.....................................................5
4 CLEANING-MAINTENANCE...............................5
4.1 Cleaning ...................................................................5
ront panel (Fig.2.1)...........................................4
GLOSSARY OF SYMBOLS
: ON (power switched on)
I
: OFF (power switched off)
O
: Type B device
: Class II protection
4.2
Daily disinfection.............................. ............................5
4.3 Maintenance..............................................................6
5 USEFUL INFORMATION........................................6
5.1 Accessories and spare parts.......................................6
5.2 Material in direct or indirect contact with patient..... 7
5.3 Operating principles..................................................7
5.4 Alarms-Safety devices-Indications ........................... 7
5.5 Useful Information ...................................................8
5.6 Technical characteristics ........................................... 8
5.7 Standards...................................................................9
5.8 Troubleshooting.......................................................10
Notes.................................................................................11
: Do not use oil or grease
: Technical information
: Consult the accompanying documents
: Keep in the vertical position
: Fragile - handle with care
: Do not expose to open ames
: Oxygen concentration warning light
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GENERAL SAFETY GUIDELINES
Only persons who have read and understood this entire manual
should be allowed to operate the MARK 5 Nuvo Lite
.
The WARNINGS below indicate a potential
hazardous situation. If conditions are not
avoided a situation could occur that results
in serious injury or death.
Oxygen is not a ammable gas, but it •
accelerates the combustion of materials. Do
notuse inexplosive atmosphere.To avoidrisk
of re 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. Ifconcentratorisoperating
while not connected to patient, position
cannula so that the gas ow is diluted in the
ambient air.
Improper patient connection to and use of•
the cannula may result in injury including
strangulation.
Use of other accessories not described in this•
User's Guide is not recommended. Patient
bene t may be diminished.
No modi cation to the equipment is allowed. •
To do so may affect patient bene t.
Contraindications; Those who continue to•
smoke (because of the increased re risk
and the probability that the poorer prognosis by smoking will offset the treatment
bene t).
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 quali-
ed service personnel.
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 indicated on the
manufacturer’s plate on the rear panel of
the device.
We recommend against the use of extension•
cordsoradapters,asthey arepotentialsources
of sparks and re.
The• Mark 5 Nuvo Lite 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• Mark 5 Nuvo Lite must only be used
for oxygen therapy and only on a medical
prescription. The indicated daily duration
and ow must be followed, otherwise it may
present a risk to the health of the patient.
Do not use in a specifically magnetic•
environment (MRI, X-ray, etc.). May cause
device malfunction.
This unit may be equipped with a polarized•
plug. That is one blade wider than the other.
If it does not t into the outlet, reverse
the plug. If it still does not t, contact a
quali ed electrician. Do not defeat this
safety feature.
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.
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CONFORMITY WITH IEC60601-1 (2nd
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:
Assembly, tting, extensions, adjustments, •
modi cations 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 speci cations,
the manufacturer is not responsible in the event
of an accident.
1.1 METHOD FOR WASTE DISPOSAL
All waste from the device (Patient Circut,
Filters, Etc.) must be disposed of using methods
appropriate to the civil authority of the location
where disposed.
1.2 METHOD FOR DISPOSING OF
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.
2. DESCRIPTION
This device complies with the requirements of
the FDAQuality 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 electro-
surgical equipment, de brillators, 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 speci ed by the EN 60601-
1-2 standard.
1. UNPACKING and PACKAGING
The Oxygen Concentrator is packaged to
protect the device from damage while being
transported and stored. Check for damage to
the packaging. After 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 another
section of this User's Guide.
The Mark 5 Nuvo Lite is intended to supply
supplemental oxygen to persons requiring low
ow oxygen therapy. It is not intended to be
life supporting or life sustaining. It produces
oxygen enriched product by concentrating the
oxygen contained in room air. It can be used to
administer oxygenwith nasal cannulasor another
type of device.
The Mark 5 Nuvo Lite is easy to use.
The single ow adjustment knob allows:
The device to be easily adjusted to the•
prescribed ow rate,
The equipment supplier or medical staff to•
limit ows to a speci c ow rate with a built-
in 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 Nuvo Lite with the accessories
recommended by Nidek Medical Products, Inc.
Refer to section 5.
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3. STARTING UP / INSTALLATION
4
5
5
5
2.1. Front panel (Fig. 2.1)
1 - I/O (ON/OFF) Switch
2 - Indicator Lights
3 - Oxygen product outlet
4 - Flow adjustment knob (l/min.)
5 - Circuit Breaker
11
9
1
3
3
3
4
3.1. Use in direct oxygen therapy
a. Ensure that the switch (Item1 in Fig.2.1) is in
the O (OFF) position.
b. For use without Humidi er Bottle connect
the cannula directly to the concentrator oxygen
product outlet (Item 3 in Fig 2.1). Simply slide
the cannula over the oxygen outlet (Fig 3.1).
c. If a Humidifier Bottle is prescribed:
Unscrew the lid from the bottle and ll with
water, per the humidi er bottle manufacturer's
recommendation. Re-attach the lid to the bottle
and connect to the oxygen concentrator. Place
the bottle on the concentrator and secure with
the attachment straps as indicated in (Fig.2.2).
Connect the clear plastic tube supplied to the
Humidi er Bottle by use of the DISS tting.
Connect the other end of the tube to the oxygen
outlet (Item 3 in Fig 2.1). Connect the cannula
to the outlet on the Humidi er Lid (Fig. 3.2).
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NOTE: The tube between the cannula and
12
the Mark 5 Nuvo Lite should be limited to 20
meters (60 feet) long.
7
10
2.2. Rear panel (Fig. 2.2)
6 - Humidi er
7 - Filter
8 - Power Cord
9 - Elapsed Time Meter
10 - Technical Label
11 - Humidi er Tube
12 - Humidi er Bottle Attachment Strap
13 - Power Cord Retainer
13
d. Ensure that all of the parts are connected
correctly to avoid leaks.
No Humidi er Bottle.
This illustration shows the
Cannula attached directly
8
to the oxygen product
outlet connection on the
concentrator.
(Fig. 3.1)
This illustration shows the
Humidi er Bottle in place. A
tube is attached to the DISS
tting on the bottle lid and
to the oxygen product outlet
connection. The cannula is
attached to the outlet on the
bottle lid.
(Fig.3.2)
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e.Plugthepower cable intoa poweroutlet(Fig.
3.3) of the correct voltage and frequency as
de ned on the manufacturer's technical label
(Fig 2.2).
3.2 Turning off device
At the end of the treatment, press the I/O Switch
to place it in the O (OFF) position to stop the
device. The oxygen enriched air ow continues
for approximately one minute after the device
is stopped.
4. CLEANING - MAINTENANCE
115V (Fig 3.3) 230V
f. Press the power switch (I/O) to the ON
position (I). The green indicator light glows
indicating power is available.
Note: the required oxygen concentration is
normally obtained within ve minutes after
the unit is started.
g. Turn the ow adjustment knob (Item 4 Fig.
2.1) 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.
Forthe equipment supplieror medical staff:
The ow adjustment knob can be locked to
limit it to a speci c predetermined value.
4.1. Cleaning
Only the outside of the Mark 5 Nuvo Lite is
to be cleaned. Use a soft dry cloth, a damp
sponge or wipes with alcohol based solution.
The cabinet must then be thoroughly dried.
Acetone, solvents or any other in ammable
products must not be used. Do not use abrasive powders.
The removable cabinet air lter (Item 2 Fig.4.1)
must be cleaned in warm water and household
detergent weekly or after approximately 100
hours of use. Dry before reinstalling. More
frequent cleaning is recommended in dusty
environments.
9
h. Check the oxygen flow out of the
administration device (nasal cannula or other)
by placing it near the surface of a glass of
water. The ow should disturb the surface of
the water.
i. Adjust the nasal cannula to suit your face,
see (Fig. 3.4).
(Fig. 3.4)
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Fig. 4.1
1. Filter / Silencer
2. Cabinet lter
3. Ventilation grill
Note: Shown with grate removed.
4.2. Daily disinfection
Because there is a nal product lter inside
the device, daily disinfection concerns only
the external oxygen therapy accessories:
humidifier, nasal cannulas (refer to the
respective instructions for use).
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5. USEFUL INFORMATION
The device must be switched off and disconnected from its power source when alcohol
based solutions are used.
a. The following minimum guidelines must
be observed
• Humidi er: (If prescribed by a physician)
Clean according to the manuf actur er's
instructions. If no instructions are provided,
do the following:
Daily
• Empty the water from the humidi er.
• Rinse the humidi er ask under running
water
• Fill humidi er up to the mark with water
per the manufacturer's recommendations.
Regularly
Disinfect the humidi er parts by immersing •
them in a disinfection solution. (In general
we recommend using a solution of 1 part
vinegar diluted with 10 parts water).
• Rinse and dry.
• Check that the humidi er lid seal is in
good condition
5.1. Accessories and spare parts
The accessories used with the Mark 5 Nuvo
Lite must:
• be oxygen compatible.
• be biocompatible.
• comply with the requirements of the FDA
Quality System Regulation.
The connectors, tubes, nasal cannula, 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.
NOTE: The use of certain administration
accessories which are not speci ed for use with
this concentrator may reduce its performance
and void the manufacturer’s responsibility(ISO
8359).
• Oxygen tubing and nasal cannula
Follow the manufacturer’s instructions.
b. For each new patient
Follow the instructions from the humidi er
manufacturer. The Mark 5 Nuvo Lite must be
cleaned and disinfected as per the above instruc-
tions. The cabinet air lter should be washed
or replaced. The entire oxygen administration
circuit (oxygen therapy nasal cannula, 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 Mark
5 Nuvo Lite.
AVAILABLE ACCESSORIES
IF PRESCRIBED BY A PHYSICIAN
Humidi er: Ref: 9012-8774
Cannula with 2 m (7 ft) tubing: Ref: 9012-8780
Extension Tubing 7.7 m (25ft): Ref: 9012-8781
Tubing Adapter: Ref: 9012-8783
The items listed above are available from
Nidek Medical Products, Inc.
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5.2. Materials in direct or indirect contact
with the patient
Concentrator casing ................................ABS
Power Cord ........................................... PVC
Cabinet Air Filter ..............................Polyester
I/0 (On/Off) switch................................Nylon
Casters....................................................Nylon
Flow adjustment knob..............................ABS
Oxygen product outlet ...................Aluminum
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Printed labels.............................Polycarbonate
Pipe/Tubing..........................Aluminium,PVC,
polyurethane or silicone
Humidi er.................................Polypropylene
Humidi er tube........................................PVC
Filter .........................................Polypropylene
Power Quality•
A rapidly pulsing alarm is indicative of a
power quality problem that normally will not
affect the devices output. If the problem persists contact your power provider.
Process Fault•
In the case of a process fault, a visible and
audible alarm is activated (continuous red
light and audible alarm, see trouble shooting
section).
5.4.2. Safety devices
• Compressor motor
5.3. Operating principle
The compressor sends ltered room air to a
solenoid valve, which allows compressed air to
pass to the column in production. The columns
contain a molecular sieve, whose function is
to adsorb the nitrogen and thus allow oxygen
to pass. The oxygen enriched product is then
directed through a pressure reducing valve to
the adjustable ow valve and continuing to the
oxygen product outlet tting.
During this time, the column which is being
"regenerated" is connected to the ambient air
and ow of oxygen enriched product is passed
through it (from the column "in production"). In
this way, when one column is in production, the
other is in a nitrogen desorption or "regenera-
tion" phase. The oxygen enriched product nally
passes through a nal product lter located prior
to the oxygen outlet tting.
5.4. Alarms - Safety devices - Indications
5.4.1. Alarms
No Voltage detection:•
Thermal safety is ensured by a thermal switch
situated in the motor winding (145 ± 5oC).
• Electrical protection
A 5A circuit breaker is incorporated into the
front cabinet of all models.
Class II devices with insulated casings
(EN60601-1 standard)
• Safety valve
This is tted on the compressor outlet and is
calibrated to 2.7 bar (40 psig).
5.4.3 Indicators
The green indicator light (Fig.5.1) indicates•
that power is applied to the device and that
it is ready to provide oxygen enriched air
to the patient. To be lighted, it is necessary
that the device power plug be inserted into
the wall outlet and ON/OFF (I/O) switch be
activated.
In the event of a loss of mains power, an intermittent audible alarm is activated. Test alarm by
activating the I/O (ON/OFF) switch with power
cable unplugged from wall outlet.
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5.4.3 Indicators (continued)
5.5.4 Maintenance of the Device Alarms
The red indicator light is utilized to warn•
the patient of a system fault. The event
that can cause the red indicator to be lighted is abnormal system pressure.
Red Indicator Green Indicator
No special maintenance is required. The alarm
set-point is factory set and the setting cannot
be adjusted.
The equipment supplier veri es that the device
is still operating correctly when the routine
checks are performed.
5.6. Technical characteristics
Dimensions: L x W x H: 36x23x58.5 cm (14
x 9 x 23 in.)
Caster diameter: 3.8 cm (1.5 in.).
Tilt angle (transport with humidi er tted)
30o.
Weight: 14.5 kg. (32 lbs) varies by model.
Noise level 45 to < 40 dBA (depends on
model).
Flow values
(Fig. 5.1)
12 position ow valve 0.125-5 liters/minute.
(Some models may have other values.)
Accuracy of ow supplied
In compliance with the ISO 8359 standard.
The ow supplied is equal to the selected ow,
accurate to within ± 10 % or 200 ml/min,
whichever is the larger.
Oxygen Concentration
• at 2 l/min: >90%.
• at 5 l/min: 90%. (+6.5%/-3%)
(Values at 21oC and at one atmosphere pressure).
Maximum ow: 5 l/min.
The variation of the maximum ow does not
exceed ± 10 % of the indicated value when a
back pressure of 7 kPa (1 psig) is applied to
the output of the device. The maximum outlet
pressure is 50 kPa (7 psig).
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Electrical power supply:
Mark 5 Nuvo Lite Serial No. ________
_________________________________
Rating: 115/230V 60Hz 230V 50Hz
Average Power: 330W(avg) 300 W(avg)
Protection Class: Class II Class II
Mains Protection: 5A 5A
Filters:
At the rear of the device: a cabinet air lter.
At the compressor input: an inlet air lter, 5 µm,
located behind the cabinet air lter.
Before the oxygen outlet: a nal product lter,
< 0.3 µm. (technician only).
Air circulation
A tubeaxial fan cools the compressor compartment.
Environmental limit conditions
The performances of the device (especially the
oxygen concentration) are quoted at 21oC (70oF)
and one atmosphere. They may change with
temperature and altitude. For further information, please consult the maintenance manual Ref
# 2010-8405.
• The device must be stored, transported and
used in the vertical position only.
• Ambient temperature of between 5oC and
40oC (40oF to 104oF) operation.
• Storage temperature from -20oC to 60oC
(-4oF to 140oF).
• Relative humidity of between 15% and 95%
operation and storage, both non-condensing.
• Altitude(21oC): Up to 2,286m (7,500ft)
without degradation; Consult your equipment provider for further information regarding 2,286m to 4000m (7500 to 13000
ft)
• Complies with EN60601-1 standard; spilling a glass of water.
5.7. Standards
Date rst used : __________________
Maintained by: __________________
________________________________
Your distributor: ________________
Address : _______________________
________________________________
Telephone : _____________________
PREVENTIVE MAINTENANCE
a. Wash cabinet lter weekly.
b. Inspect inlet air lter at each patient visit.
Replace lter every 2 years, or more often
depending on environment.
c. Check oxygen concentration every 5,000
or 1 year.
The manufacturer’s instructions for the
preventive maintenance of the devices are
de ned in the maintenance manual. Check
with your service provider for any updates to
recommended schedules. The work must be
carried out by suitably trained technicians.
Use original spare parts only (see Pg. 10)
Upon request, the supplier can provide circuit
diagrams, spare parts lists, technical details
or any other information of use to quali ed
technicalpersonnel for partsofthe devicewhich
are designated as being the manufacturer’s
responsibility or by the manufacturer as
repairable.
EN 60601-1[UL60601-1:2003],CAN/CSAC22.2 No.601.1-M90 w/A1&A2: Electrical
Safety- Medical Devices.
EN60601-1-2:2001 Electromagnetic Compatibility
August 20122010-8400 Rev G 9
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5.8 Troubleshooting.
Observations
The I/O (ON/OFF) button is in the
ON position but the device does not
operate.
The intermittent alarm sounds.
Red light remains lighted.
A rapidly pulsing alarm.
The alarm test does not work.
See 5.4.1
The compressor operates and the
I/O (ON/OFF) button is in the ON
position but the green light is not
lighted.
The I/O (ON/OFF) button is ON and
the compressor is operating but there
is no ow. The audible alarm sounds
(continuously).
Possible Causes
Power cable is not correctly
plugged in.
Power failure.
Product pressure is too low or
too high.
Power Quality
Capacitor is not charged
Internal electrical fault.
Faulty indicator.
Pneumatic connection broken
or other pressure problem.
Solutions
Check the cable connection.
Check the circuit breaker on the
front of the unit under the owme-
ter.
Contact your equipment supplier.
If the problem persist contact your
power provider.
Backup Capacitor has discharged;
operate unit for approximately 10
minutes and retest.
Contact your equipment supplier.
Contact your equipment supplier.
Stop the device by pressing the
I/O (ON/OFF) button and contact
your equipment supplier.
The I/O (ON/OFF) button is ON, the
compressor is operating, there is a
ow but the audible alarm sounds
continuously.
The compressor stops in mid-cycle,
then starts again after a few minutes.
The oxygen enriched product ow
is interrupted at the nasal cannula
outlet.
The ow at the nasal cannula outlet
is irregular.
Maintenance Items
Cabinet Air Filter- Ref: 8400-1025; Wash weekly; Replace as needed.
Humidi er Tubing- Ref. 8400-8409; Wash in warm water; Replace as needed.
Inlet Air Filter- Ref: 8400-1180; Inspect at each patient visit, Replace every 2 years.
Please record all maintenance activity on the Maintenance Log found in the Service Manual
and online at www.nidekmedical.com under the 'Maintenance Log' tab.
Internal electrical fault.
Pneumatic circuit fault.
Compressor thermal safety
device has been activated.
Fan is not working.
Dirty Filters.
Tube disconnected or humidi er
not tight.
Cannula tubing is kinked.
Stop the device and contact your
equipment supplier.
Stop the device and wait for it to
cool down. Clean cabinet lter.Start
up again. Reset the circuit breaker.
Contact your equipment supplier.
If the device does not start, contact
your equipment supplier.
Check that tubing connections are
secure and that the tubing is not
kinked.
Straighten the tubing ; contact your
equipment supplier if damaged.
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NOTES
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Nidek Medical Products, Inc.
3949 Valley East Industrial Drive
Birmingham, Alabama 35217 U.S.A.
Tel: 205-856-7200 Fax: 205-856-0533
info@nidekmedical.com
www.nidekmedical.com
EU Representative
mdi Europa GmbH
Langenhagener Str. 71
30855 Hannover-Langenhagen
Germany
Tel: +49-511-39-08 95 30
Fax: +49-511-39-08 95 39
info@mdi-europa.com
www.mdi-europa.com
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