Nidek Mark 5 Nuvo Lite User manual
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
August 20122010-8400 Rev G 1
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.
2
August 2012
2010-8400 Rev G
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.
August 20122010-8400 Rev G 3
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).
6
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)
4
August 2012
2010-8400 Rev G
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