2010-2324CE Rev A
6
November 2013
to 105
o
F) operation.
• Storage temperature from -20
o
C to 60
o
C (0
o
F
to 140
o
F).
• Relative humidity of between 15 % and 95 % operation
and storage, both non-condensing.
• Altitude(21
o
C): Up to 1500m (5000ft) without degrada-
tion; Consult your equipment provider for further infor
mation regarding 1500 m to 4000m (5000 to 13000ft).
• Complies with EN60601-1 standard; spilling of a glass
of water.
IV. 7. Standards
ISO 8359:1996 Oxygen concentrators for medical use.
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 MB
(patient circuit, filter,
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 recycleable.
Furthermore, as part of the marking (directive 93/42/EEC),
the serial number of the device disposed of must be sent to
the
Nidek
Medical
technical service department if the unit
has the marking.
Accuracy of flow supplied:
I
n compliance with the ISO 8359 standard, the flow supplied
is equal to the flow set on the flowmeter, accurate to within ±
10% or 200 ml/min, whichever is the larger of the two.
Average oxygen content:
5 1/min, 8 l/min, 10 1/min: 90%. +5.5% / -3.0%
(Values at 21
o
C and at one atmosphere pressure).
Minimum recommended flow: 1 l/min on 5L unit, 2 l/min
on 8 & 10L units.
Maximum recommended flow: 5 l/min, 8 l/min or 10 l/min
model specific.
The variation of the maximum recommended flow does not
exceed ± 10 % of the indicated value when a back pressure
of 6.9 kPa (1 psig) is applied to the output of the device. The
maximum outlet pressure is: 7psig for 5 l/min, 15 psig for 8
l/min, and 20 psig for 10 l/min.
Electrical power supply:
5 l/min Model:
115 V Units
230 V Units
Frequency:
60Hz
50/60Hz
Average Power:
410 watts
420 watts
Protection Class:
Class II
Class II
Mains Protection:
10A
5A
8
l/min Model:
115 V Units
230 V Units
Frequency:
60Hz
50/60Hz
Average Power:
490 watts
490 watts
Protection Class:
Class II
Class II
Mains Protection:
10A
5A
10 l/min Model:
115 V Units
230 V Units
Frequency:
60Hz 50/60Hz
Average Power:
700 watts 490/585 watts
Protection Class:
Class II Class II
Mains Protection:
10A 5A
Filters:
At the rear of the device: a cabinet air filter.
At the compressor input: an inlet air filter, behind cabinet
air filter.
Before the oxygen outlet: a final product filter < 0.3 µm.
(technician only)
Air circulation:
One tubeaxial fan cools the compressor compartment and a
second fan cools the heat exchanger coil on 8 & 10 lpm models.
.
Environmental limit conditions:
The performance of the device (especially the oxygen concen
-
tration) are quoted at 21
o
C (70
o
F) and one atmosphere. They
may change with temperature and altitude. For further infor
-
mation, please consult the maintenance manual.
• The device must be stored, transported and used in the
vertical position only.
• Ambient temperature of between 10
o
C and 40
o
C (50
o
F
Nuvo
Serial No. ___________________________
Date first used:
___________________________
_________________________________________
Maintained by: ___________________________
_________________________________________
Your distributor: _________________________
Address : ________________________________
_________________________________________
_________________________________________
Telephone : ______________________________
