2010-2324CE Rev A
2
November 2013
USE OF OXYGEN
Oxygen is not a flammable gas, but it accelerates the
combustion of materials. To avoid all risks of fire,
the
Mark 5 Nuvo MB
should be kept away from
all flames, 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 flow is diluted in the ambient air.
Place the device in a ventilated area free from
smoke and atmospheric pollution (rear filter
unobstructed).
The
Mark 5 Nuvo MB
must only be used for oxygen
therapy and only on a medical prescription. The
indicated daily duration and flow 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.)
USE AND MAINTENANCE OF 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 fire.
The
Mark 5 Nuvo MB
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
with Modular Bed (MB)
.
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, fitting, extensions, adjustments, modifications
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
specifications, the manufacturer is not responsible in the event
of an accident.
This device complies with the requirements of the FDA Quality
System Regulation and the 93/42/EEC
E
uropean directive
but its operation may be affected by other devices being used
near by, such as diathermy and high frequency electro-surgi-
cal equipment, defibrillators, 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
specified by the EN 60601-1-2 standard.
I. DESCRIPTION
The
Mark 5 Nuvo MB
is intended to supply supplemental
oxygen to persons requiring low flow oxygen therapy. It is not
intended to be life supporting or life sustaining. It produces an
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 MB
is easy to use.
The single flow adjustment knob allows:
• the device to be easily adjusted to the prescribed flow rate,
• the equipment supplier or medical staff to limit flows to a
specific flow 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 MB
with the accessories recommended by
Nidek Medical Products, Inc.
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