September 2013
2010-8403CE Rev C
3
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, fi tting, extensions, adjustments,
modifi 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 specifi cations,
the manufacturer is not responsible in the event
of an accident.
This device complies with the requirements of
the FDA Quality 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, defi 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 specifi 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 condi-
tion guidelines are discussed later in another
section of this User's Guide.
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 environ-
mentally 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 compo-
nents normally used in operation. Any accessories
not original to the device must be disposed of in
accordance with the individual product markings
for disposal. Furthermore, as part of the marking
directive 93/42/EEC, the serial number of the
device disposed of must be sent to Nidek Medi-
cal if the unit has the
marking.
2. DESCRIPTION
The
Mark 5 Nuvo Lite
is intended to supply
supplemental oxygen to persons requiring low
fl 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 oxygen with nasal cannulas or another
type of device.
The
Mark 5 Nuvo Lite
is easy to use.
The single fl ow adjustment knob allows:
•
The device to be easily adjusted to the
prescribed fl ow rate,
•
The equipment supplier or medical staff to
limit fl ows to a specifi c fl 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 accesso-
ries recommended by Nidek Medical Products,
Inc. Refer to section 5.
