Bowa CV3-400, Instructions For Use Manual, Page: 10 / 132

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3. Instruments must only be used by trained medical staff.
4. Do not use for the preparation of metallic implants, such as stents.
5. Do not use on the heart, on the central circulatory system or on the central
nervous system.
6. The operation area must be free of explosive gases or inflammable fluids and
materials.
7. The instrument must not come into contact with any other uninsulated instru-
ments or objects.
8. Perform coagulation only when the contact surfaces are visible.
9. Care should be taken when operating in the vicinity of nerves.
10. To avoid patient injury in the event of accidental activation, do not lay active
instruments on the patient.
5.3 EMC INSTRUCTIONS
For detailed EMC information refer to the LOTUS Series 4 Ultrasonic Surgical
Systems & Accessories instructions for use.
6 REPROCESSING INSTRUCTIONS
Please ensure that following use the Single Use Handpiece / Double Blade
Sleeve has been removed from the Transducer and disposed of as clinical waste.
Reprocessing instructions have been validated by the manufacturer to ensure the
capability of the LOTUS system for reuse. Instruments should be sterilized prior
to use using the following guidelines. It is the responsibility of the user to ensure
that reprocessing is performed in a controlled manner using validated and
calibrated equipment. Any deviation by the reprocessor from these instructions
should be evaluated for effectiveness and potential adverse consequences. All
Transducers are provided clean but not sterile. All Transducers have been inspected
prior to shipment. Please contact your local dealer or Technical Service if further
information is needed. Transducers can be autoclaved a maximum of 50 times.
• Follow instructions and warnings issued by the manufacturer for cleaning and
equipment use.
• 285 ºF (140 ºC) is NOT to be exceeded during the reprocessing steps.
• Do NOT use ULTRASONIC WASHING or CYDEX.
• Do NOT sterilize the LOTUS generator.
• Scratches or dents to the Waveguide can result in breakage or malfunction.
• Care should be taken to remove debris or tissue that may collect on the LOTUS
generator.
• Place the end cap on the plug when the Transducer is not connected to the
generator, in particular during transport, storage and reprocessing.
• Remove the end cap immediately prior to connecting to the generator in the
non-sterile area.
• To protect the Waveguide, it is recommended to use the following trays for the
automated cleaning and sterilization.
REF TRAY CODE
773-984
SV3-200
CV3-400
ES4-200CT
ES4-400CT
LR3-200
LR3-400
W3-200
W3-400
DB3-400
DB3-100
773-985
SV3-500
ES4-500CT
773-984 / 773-985
LOTUS reprocessing basket with lid