User Manual MUT_RD_009H_GB Page
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9.1
Transportation
For transportation, the weight (7 kg) and dimensions (L x w x h = 365 x 320 x 265 mm) of the Control Unit
must be taken into account.
When transporting the EyeOP1 Control Unit over short distances, carry using the handle located at the rear.
Avoid shocks and carry using both hands.
To transport the device over long distances, place the EyeOP1 Control Unit in its storage case and avoid
shocks.
9.2
Storage and use conditions of the Control Unit and EYEOP-PACK
Storage
Storage temperature
4 to 40 °C
Relative humidity
20 to 80 %
Pressure
750 hPa to 1013 hPa (1 atm)
Transport
Storage temperature
4 to 40 °C
Relative humidity
20 to 80 %
Pressure
750 hPa to 1013 hPa (1 atm)
Use
Operating temperature
15 to 25°C
Relative humidity
20 to 80 %
Pressure
At atmospheric pressure close to normal pressure (1 atm)
When the medical device is stored after use, disconnect the firing pedal and the power
cable from the control unit.
9.3
Lifetime
The lifetime of the EyeOP1 control unit is 7 years.
The validity period of the EYEOP-PACK consumable is 36 months.
10.
INFORMATION ON USER MANUAL UPDATES
Compared to the previous version of the User Manual on the market, the different updates are as follow:
SECTION
COMMENTS
SECTION 2 §1
SECTION 2 §5
SECTION 3 §4.2.1
SECTION 3 §2.2 & SECTION 4
§2.2
SECTION 4 §2.2
SECTION 6 §3 Step 4.1
Addition of the expected benefits.
Creation of a part “User profile”.
Update of the Tyvek covering picture with the sterile barrier system symbol.
Development of the note explaining the risks to re-use the sterile single-use EYEOP-
PACK.
Addition of a note asking the user to check the green sterility indicator onf the carton
box of the EYEOP-PACK consumable.