Nidek Mark 5 Nuvo User manual
USER'S GUIDE
Mark 5 Nuvo
M5C5
OXYGEN CONCENTRATOR
[Original language is English ]
FederalLaw(US)restricts thisdevicetosale
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: Donot smoke when using oxygen or when
near this device
.
GLOSSARYOF SYMBOLS..........................................1
GENERALSAFETY GUIDELINES ............................2
I. DESCRIPTION ...........................................................2
I.1.F
ront 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
III.3.Maintenance..............................................................4
GLOSSARYOF SYMBOLS
: ON (power switched on)
: Off (power switched off).
: Type B device
IV. USEFULINFORMATION...................................4
IV.1. Accessories and spare parts.....................................4
IV.2. Materials in direct or indirect contact with
patient .....................................................................4
IV.3. Operating principles................................................4
IV.4. Alarms - Safety devices...........................................5
IV.5. Indicator light function ..........................................5
IV.6. Technical characteristics..........................................5
IV.7. Standards.................................................................6
IV.8. Method for disposing of waste................................6
IV.9. Method for disposing of device...............................6
: Do not use oil or grease.
: Technical information.
: Consult the accompanying documents.
: Class II protection
: Do not expose to open ames.
: Keep in the vertical position.
: Fragile - handle with care.
May 20112010-2224F Rev C 1
GENERALSAFETY GUIDELINES
Only persons who have read and understood this entire manual
should be allowed to operate the MARK 5 Nuvo [M5C5].
USE OF OXYGEN
Oxygen is not a ammable gas, but it accelerates the
combustion of materials. To avoid all risks of re, the
MARK 5 Nuvo [M5C5] should be kept away from
all ames, incandescent sources and sources of heat
(cigarettes),as wellasanycombustibleproductssuch
as oil, grease, solvents, aerosols, etc.
Do not use in an explosive atmosphere.
Avoid letting oxygen accumulate on an upholstered
seat or other fabrics. If the concentrator is operating
whilenot supplyingoxygento apatient, positionit so
that the gas ow is diluted in the ambient air.
Place the device in a ventilatedarea free from smoke
and atmospheric pollution (rear lter unobstructed).
The MARK 5 Nuvo [M5C5] must only be used for
oxygentherapyandonlyonmedicalprescription.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 speci cally magnetic environment
such as (MRI, X-ray, etc.)
CONFORMITYWITH IEC60601-1 (§ 6.8.2 B):
"The manufacturer, assembler, installer or distributor are not
consideredtobe responsiblethemselvesfor theconsequences
onthe safety,reliability andcharacteristics of a device unless:
• The assembly, tting, extensions, adjustments, modi cations
or repairs have been performed by persons authorized by the
party in question,
• The electrical installation of the corresponding premises
complies with local electrical codes. ( e.g. IEC / NEC ).
•Thedeviceisusedinaccordancewiththeinstructionsforuse."
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.
This device complies with the requirements of the FDAQua-
lity System Regulation 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
portabledevices, microwaveovens, television,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.
USEAND MAINTENANCE OF THE DEVICE
Do not open the device while in operation: risk of
electrical shock.
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 against the use of extension cords
or adapters, as they are potential sources of sparks
and re.
The MARK 5 Nuvo [M5C5] 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.
2
I. DESCRIPTION
TheMARK5Nuvo[M5C5]isintendedtosupplysupplemental
oxygen to persons requiring low ow oxygen therapy. It is not
intended to be life supporting or life sustaining. It produces
oxygenenrichedproductby concentratingtheoxygen containedinroomair.It canbeusedeithertoadministeroxygenwith
nasal cannulas or another probe or mask type of device.
The MARK 5 Nuvo [M5C5] 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 performancesdescribed pertainto the useof the
MARK5 Nuvo [M5C5] with the accessoriesrecommended
by Nidek Medical Products, Inc.
May 2011
2010-2224F Rev C
II. STARTING UP / INSTALLATION
II. 1. Use in direct oxygen therapy
6
1
a - Ensure that the switch (1) is in the 0/(OFF) position.
1
b - If used with a humidi er:
3
3
4
4
2
Unscrew the ask and ll it with water up
to the line (see the humidi er instructions).
Then screw the humidi er ask onto its lid
until there are no leaks.
5
5
I. 1. Front panel (Fig. I. 1)
1 - I/0 (ON/OFF) Switch
2 - Humidi er (space reserved)
3 - Oxygen product outlet
4 - Flow adjustment knob (l/min.)
5 - Circuit Breaker
6 - Indicator Lights
c - Connect the oxygen tube to the humidi er outlet nozzle
or to the concentrator outlet if a humidi er has not been
prescribed. The tube between the cannula and the MARK
5 Nuvo [M5C5] should be limited to 60 feet (20 meters)
long, in order to ensure that the oxygen ow rate remains
within speci cation values.
d - Ensure that all of the parts are connected correctly so as
to avoid leaks.
e - Plug the power cable into a power outlet of the correct
voltage and frequency as de ned on the
manufacturer's technical label(8).
f - Press the power switch (I/0) to the ON position (I). The
red indicator will light and the audible alarm willsound for
a few seconds until system pressure rises to the accepted
level.
g - Turn the ow 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.
7
Note: View the owmeter in the horizontal plane for accurate
settings.
7
9
I. 2. Rear panel (Fig. I. 2 )
7 - Cabinet Dust Filter
8 - Technical Label
9 - Power Cord
h - Check that the oxygen ows out of the administration
device (nasal cannulas or other) by placing the ori ce(s) on
8
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.
Note:therequiredoxygenconcentrationisnormallyobtained
within ve minutes after the unit is started.
At the end of the treatment, press the (I/0) switch to place
it in the (0) [OFF] position to stop the device. The oxygen
enriched air ow continues for approximately 1 minute after
the device is stopped.
For the equipment supplier or medical staff:
The ow adjustment knob may be locked to limit it to a
speci c predetermined value.
May 20112010-2224F Rev C 3
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