3.5 DISPOSAL
Disposal of the packaging, device and individual components must be in accordance with the regulations
in force in the country of use for the treatment and disposal of potentially bio-contaminated waste.
Do not dispose of packaging material in the environment.
4
TECHNICAL DATA
Classification of the medical device according to Directive
93/42/EEC updated with the changes made by the new
Directive 2007/47/EC
(Annex IX)
Safety class
Level of protection against electric shock
Supply gas flow rate (l/min)
Supply gas pressure (bar / PSI)
Maximum device flow rate (l/min)
Maximum gas supply pressure (bar / PSI)
External mains power supply (Power supply input)
Built-in battery: Pb-Ca battery
Power consumption
Battery fuse 12VAC
Mains fuses
The Declaration of Conformity is attached to the device
CLASSIFICATION
SAFETY CATEGORY
O
AND N
O SPECIFICATIONS
2
2
ELECTRICAL SPECIFICATIONS
Refer to Annex No.0Z00H0004
IIa (in application of rule 11)
Short-term duration
Non-invasive medical device.
Active medical device
Type I
Applied part type B
~ 100 LPM
3.5 ÷ 6 bar - 50 ÷ 87 PSI
12 Nl/min
6 bar - 87 PSI
AC 100 ÷ 240 V +/-10%
50 ÷ 60 Hz 1.5 A
Capacity: 7Ah;
Rated voltage 12VDC
40VA
F1A (5 x 20 mm)
F1A (5 x 20 mm)
10 - 33
ENGLISH