2010-2224F Rev C
2
May 2011
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 well as any combustible products such
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
while not supplying oxygen to a patient, position it so
that the gas ow is diluted in the ambient air.
Place the device in a ventilated area free from smoke
and atmospheric pollution (rear lter unobstructed).
The
MARK 5 Nuvo [M5C5]
must only be used for
oxygen therapy and only on 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 speci cally magnetic environment
such as (MRI, X-ray, etc.)
USE AND 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.
GENERAL SAFETY GUIDELINES
Only persons who have read and understood this entire manual
should be allowed to operate the
MARK 5 Nuvo [M5C5]
.
CONFORMITY WITH IEC60601-1 (§ 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, 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 ).
• The 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.
This device complies with the requirements of the FDA Qua-
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
portable devices, microwave ovens, television, induction pla-
tes or even remote control toys or any other electromagnetic
interferences which exceed the levels speci ed by the EN
60601-1-2 standard.
I. DESCRIPTION
The
MARK 5 Nuvo [M5C5]
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 contai-
ned in room air. It can be used either to administer oxygen with
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 performances described pertain to the use of the
MARK 5 Nuvo [M5C5]
with the accessories recommended
by Nidek Medical Products, Inc.
