SciCan E-STATIS Prep 40-P Manuel De L'opérateur page 5

1 Important Information
Electricity:
Electrical shock caused by incorrectly connecting third-party system to the medical device.
• When installing and operating the medical device with treatment equipment and devices from other
manufacturers, observe the provisions in "Protection against electrical shock," "Leakage current," and
"Non-grounding the application part" in accordance with IEC 60601-1.
Risk from the lack of control equipment:
Hazards can arise if control equipment is not available for changing the speed and the direction of rotation.
• The connected dental treatment unit must have control equipment for changing the speed and direction
of rotation.
• In addition, the accompanying documents must refer to them due to responsibilities arising from safety,
reliability and performance.
Premature wear and tear; malfunctions caused by improper care and maintenance:
Foreshortened product life:
• Perform proper care and maintenance operations on a regular basis.
Malfunctions from electromagnetic fields:
The product meets the applicable requirements regarding electromagnetic fields.
Given the complex interactions between equipment and cell phones, the product may be influenced by a cell
phone that is in use.
• Do not use cell phones in medical offices, hospitals, or laboratories.
• Turn off electronic devices such as computer storage media, hearing aids, etc. during operation.
Damaged cord / brittle cord:
Electric shock
• Inspect the cord before use.
Instrument tubing damage as a result of adhesive labels:
The instrument tubing may break
• Do not attach adhesive labels or tape to the tubing.
Endangering of the practitioner and the patient:
Stop using the device immediately in the event of damage, irregular running noises, excessive vibrations,
unusual generation of heat or if the drill bit is not firmly gripped.
Note:
Together with the dental treatment device, this medical device meets the requirements of IEC 60601-1-2.
Only trained personnel are authorised by the manufacturer to repair and maintain the medical device.
Any claim under warranty shall be excluded if defects or the consequences thereof are due to manipulation
or modifications to the product by the customer or by any third parties not authorized by SciCan.
Product Variant
The E-STATIS Prep 40-P is a derivative of SciCan's E-STATIS 40 kit.
Page 5
E-STATIS Prep 40-P