User Manual MUT_RD_009H_GB Page
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The EYEOP-PACK consumable, containing the therapy probe and coupling cone, is intended
for single-use. Consequently, it must not, under any circumstance, be reused.
The EYEOP-PACK elements are ethylene-oxide sterilized. Before use, check the sterility of the
product by making sure the packaging is undamaged.
Do not resterilize the EYEOP-PACK elements, before or after use. In case of sterility problems
due to damaged packaging, do not use the product.
Check for leakage of the coupling cone tubing, this could prevent sufficient suction.
An inappropriate re-sterilization by the user, not authorized by EYE TECH CARE, could damage
the elements of the EYEOP-
PACK consumable, such as the probe’s transducers, and could lead
to under-treatment and/or undesired treatment on surrounding tissues.
The parameters of the therapy probe are specific to each probe and determine the ultrasound
energy delivered to the patient. They are automatically detected by the Control Unit once the
therapy probe is connected to it.
Proper positioning of the coupling cone and therapy probe is essential, so the patient must
remain still in order not to displace them. If these recommendations are not complied with,
this may cause improper treatment to be delivered, or even patient injury.
The operator must be present at all times during the treatment and carefully supervise the
medical device and the patient.
3.3
Protection against electric shocks
In order to protect the persons against electric shocks, the following recommendations must be
followed:
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To avoid any risk of electric shock, this device must be connected to an earthed mains network.
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Always comply with the rules and specifications on electrical installations.
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Never open the EyeOP1 Control Unit. Only qualified personnel are authorized to undertake such an
operation.
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Keep the Control Unit away from liquids and never spray water or other liquids on it.
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In case of breakdown or prolonged disuse, it is recommended to disconnect the device.
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If the EyeOP1 control unit is moved, check that the electric plug is suitable for the equipment.
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In case of fire and risk for a device, disconnect the EyeOP1 control unit from the mains network and
contact the relevant staff.
3.4
Labelling
Before going further into this manual, read and understand the information appearing on the EyeOP1
Control Unit and EYEOP-PACK labels.
