Regulatory Information; Intended Use; Labeling Information - MORIA 5000 Serie Manual De Instrucciones

The Evo3e control unit and the electrical motors / turbines must follow the following conditions:
Temperature
Transportation 5 - 45°C / 41°F – 113°F
Storage 10 - 40°C / 50°F – 104°F
Normal conditions of use 10 - 40°C / 50°F – 104°F
V.

REGULATORY INFORMATION

Electrical Safety Standard, electromagnetic
compatibility
Annexe "Guidance and manufacturer's
declaration: electromagnetic emissions and
immunity"
Customer Service Information
EUROPE
USA
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 specific knowledge and
training in corneal surgery.
Humidity rate Atmospheric
(without condensation) pressure
30 - 90%
30 - 75%
30 - 75% 70 - 106 kPa
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
IEC 60601-1 Classe I type BF
Refer to annexe document (#65073).
Contact your local dealer or MORIA.
0459 according to MDD 93/42/CEE
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.
VII. LABELING INFORMATION
CATALOGUE NUMBER OR SKU
XXXXXX
SERIAL NUMBER
XXXXXXXX
DATE OF MANUFACTURE
YYYY/MM/DD
MANUFACTURER
XXXXXXX
CAUTION : CONSULT ACCOMPANYING DOCUMENT(S)
XXXXXX
CONSULT OPERATING INSTRUCTIONS
XXXXXX
DISCARD IN A SEPARATE COLLECTION BIN
WARNING AGAINST ELECTROSTATIC DISCHARGES
WARNING AGAINST INTERFERENCE RISK
REFER TO USER MANUAL
SIGN OF GENERAL SAFETY
ALTERNATIVE CURRENT
TYPE « BF » APPLIED PARTS: PROTECTION AGAINST ELECTRIC SHOCK :
• LEAKAGE CURRENT
• GROUNDED POWER SYSTEM
NORMAL CONDITIONS OF USE
75%
40°C
EVO3E CONTROL UNIT AND MOTORS/TURBINES:
TEMPERATURE: 10°C – 40°C / 50°F – 104°F, HUMIDITY RATE: 30 - 75%
10°C
30%
70%
NORMAL CONDITIONS OF USE
35°C
SINGLE USE ITEM :
15°C
TEMPERATURE: 15°C – 35°C / 59°F – 95°F, HUMIDITY RATE: 30 - 70%
30%
IP X6
FOOTSWITCH PROTECTED AGAINST POWERFUL WATER JETS
IP X8
FOOTSWITCH PROTECTED AGAINST WATER SUBMERSION BEYOND 1 METER (3,3 FEET)
THIS SIDE UP
FRAGILE
KEEP DRY
CAUTION FOR USA ONLY: US FEDERAL LAWS RESTRICT THIS DEVICE TO SALE BY, OR ON
THE ORDER OF, A PHYSICIAN.
4
#65060/INTL-J-09.2017 MORIA