MORIA EVOLUTION 3E - Technical Specifications; Regulatory Information; Intended Use

#65060/INTL-K-10.2020 MORIA 6
IV TECHNICAL SPECIFICATIONS
The control unit is mainly composed of the following elements:
• 1 x 12V-7Ah battery (back-up)
• 1 x transformer
• 2 x vacuum pumps: vacuum circuit (main pump + « back-up » pump)
• valves for the vacuum & gas circuit
• 1 x gas regulator used for the set up of the nitrogen pressure going to the turbine (manual
microkeratomes)
• Electronic boards.
Reference mm kg Pressure Elect. Supply
19380 430 x 240 x 190 13.6 IN : 4-6 bars / 58-87 psi
OUT : 2.5-3.5 bars / 36-50 psi
Precision of displayed values:
+/-0,2bar = 2,9 psi.
Vacuum display: +/- 30 mmHg
100-120V / 220-240V
50/60Hz
Fuse : 500 mA high switching power
Battery :12 V - 7 Ah (Pb)
1
Power input: 50 VA
19381 Double footswitches:
220 x 200 x 60
Single footswitch :
100 x 70 x 30
2.55
19361 Double footswitches:
160 x 130 x 70
Single footswitch :
100 x 70 x 30
1.05
19381C Double footswitches:
160X130X70
Simple pédale:
100X70X30
1.05
19381J Double pédale:
220X200X30
Single footswitch:
100X70X30
2.55
1
If a battery change is necessary, the used battery is classied as waste, which must be dealt with according to the specic regulations for
collection, treatment, recycling and disposal set out in directive 2006/66/EC of 9 September 2006 relating to batteries and accumulators and
waste batteries and accumulators. As such the battery must be disposed of at an appropriate collection point.
The Evolution 3E control unit and the electrical motors / turbines must follow the following conditions:
Temperature Humidity rate
(without condensation)
Atmospheric
pressure
Transportation 5 - 45°C / 41°F – 113°F 30 - 90%
Storage 10 - 40°C / 50°F – 104°F 30 - 75%
Normal conditions of use 10 - 40°C / 50°F – 104°F 30 - 75% 70 - 106 kPa
V. REGULATORY INFORMATION
MORIA S.A.
15, rue Georges Besse - 92160 Antony - France
Phone +33 (0) 146 744 674
Fax +33 (0) 146 744 670
moria@moria-int.com
http://www.moria-surgical.com
Electrical Safety Standard, electromagnetic
compatibility
IEC 60601-1 Classe I type BF
Annexe “Guidance and manufacturer’s
declaration: electromagnetic emissions and
immunity”
Refer to annexe document (#65073).
Customer Service Information Contact your local dealer or MORIA.
EUROPE
0459 according to MDD 93/42/CEE
USA
Product registered at the Food and Drug Administration (FDA).
Caution USA only: Federal law restricts the use of this device to
physicians or licensed practitioners.
For EU customers only: this symbol indicates that within the
European Union, the product must be discarded in a separate
collection bin at the end of its useful life. This applies not only to
this device, but also all accessories, including the footpedal and
electrical motors, regardless of whether those accessories are
marked with the symbol. Do not dispose as unsorted municipal
waste.
For users out of EU: please refer to local environmental regulatory
regarding waste of electrical and electronic equipment.
VI. INTENDED USE
The power unit has been designed to operate Moria keratomes by means of electric motor or turbine.
Evolution 3E console must be used only by experienced ophthalmic surgeons with specic knowledge and
training in corneal surgery.