2010-2224F Rev C
6
May 2011
MARK 5 Nuvo [M5C5]
Serial No. ____________
Date rst used:
___________________________
_________________________________________
Maintained by: ___________________________
_________________________________________
Your distributor: _________________________
Address : ________________________________
_________________________________________
Telephone : ______________________________
PREVENTIVE MAINTENANCE:
a
. Wash cabinet dust lter weekly.
b. Inspect inlet air lter at each patient visit.
Replace lter annually, or more often depending on
environment.
c. Check oxygen concentration every 5,000 hours or
one year.
The manufacturer’s instructions for the
preventive
maintenance
of the devices are de ned in the
maintenance manual. Check with your service provider
for any updates to the recommended schedules.
The work must be carried out by suitably trained
technicians certi ed by the manufacturer.
Use original spare parts only (see Pg. 7).
Upon request, the supplier can provide circuit diagrams,
spare parts lists, technical details or any other information
of use to quali ed technical personnel for parts of the
device which are designated as being the manufacturer’s
responsibility or by the manufacturer as repairable.
Medical Device Regulations require users and
service providers to report to the manufacturer any
incident that could, if repeated, result in injury to
Electrical power supply:
115 V Units
230 V Units
Frequency:
60Hz
50/60Hz
Average Power:
410 W
420 W
Protection Class:
ClassII
Class II
Mains Protection:
10A
5A
Filters:
At the rear of the device: a cabinet dust lter.
At the compressor input: an inlet air lter, behind cabinet
air lter.
Before the oxygen outlet: a nal product lter < 0.3 µm.
(technician only).
Air circulation:
A tubeaxial fan cools the compressor compartment
.
Environmental limit conditions:
The performances of the device (especially the oxygen
concentration) are quoted at 21
o
C (70
o
F) and one atmosphere.
They may change with temperature and altitude. For further
information, please consult the maintenance manual.
• The device must be stored, transported and used in the
vertical position only.
• Ambient temperature of between 5
o
C and 40
o
C (40
o
F and
100
o
F) (operation).
• Storage temperature range -20
o
C to 60
o
C. (0
o
F to140
o
F).
• Relative humidity of between 15 % and 95 % operation and
less than 95% storage, both non-condensing.
• Altitude(21
o
C): Up to 1500 m (5000 ft) without degrada-
tion;
Consult your equipment provider for further information
regarding 1500 m to 4000 m (5000 to 13000 ft).
• IPX1: Complies with EN60601-1 standard; spilling of a
glass of water.
IV. 7. Standards
EN 60601-1[UL60601-1:2003],CAN/CSA-C22.2 No.601.1-
M90 w/A1&A2: Electrical Safety- Medical Devices.
EN60601-1-2:2000 Electromagnetic Compatibility
I
V. 8. Method for disposing of waste
All waste from the
MARK 5 Nuvo [M5C5]
(patient circuit,
lter, etc.) must be disposed of using the methods appropriate
to the civil authority of the location where disposed.
IV. 9. Method for disposing of the device
In order to preserve the environment, the concentrator must
only be disposed of using the appropriate methods. All ma-
terials of construction are recyclable.
Cabinet
Dust
Filter
Air
Filter
