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1 GENERAL INFORMATION
1.1 Definition
1.1.1 Symbols used in these Directions for Use
1.1.2 Symbols used on Packaging, Device and Parts
WARNING
NOTE
If the instructions are not being
followed properly, operation may
result in hazards for the product
or the user/patient.
Additional information,
explanation on operation and
performance.
Lot number
Manufacturer
EC Representative
Class II product
Type BF applied part
Keep dry!
Refer to directions
manual/booklet
Special disposal of waste
electrical and electronic
equipment
(Directive 2002/96/EEC)
Direct current
(connection for power supply)
Caution
CE marking
Fragile
1.2 INTENTED USE
FOR DENTAL USE ONLY!
Apica Pro is a microprocessor controlled device used for root canal length determination.
1.3 Contraindications
Use of the Apica Pro is contraindicated on patients or by operators having implanted electronic
devices such as pacemaker, etc.
1.4 Warnings
In this chapter a description of serious adverse reactions and potential safety hazards for the product
or the user/patient is included. Please readthe following warnings before use.
The device may be used only by qualified dentists acting in accordance with the
national regulations.
• The device may be used only in suitable locations and not outdoor.
• Do not expose the device to direct or in-direct sources of heat. Store
and use the device in a safe environment.
• Do not use the device in the presence of inflammable anesthetic mixtures.
• Do not immerse in liquid.
• Use only original accessories.
• The external adaptor to which the device is connected should comply with standards
in force.
• Do not use the device if it appears to be damaged or defective.
• Do not carry out repairs or modifications to the device without prior
authorization by manufacturer. If any fault occurs, contact your local supplier rather
than have it repaired by an unauthorized person.
•Do not connect the device to or use it in combination with any other
apparatus or system.
• Do not use the device as an integral component of any other
apparatus or system. manufacturer will not be responsible for accidents, equipment
damage, bodily injury or any other trouble which results from ignoring this prohibition.
• Please make sure that any possible electromagnetic interference does not pose any
additional risk.
• The device may be used only by qualified dentists acting in accordance with the
national regulations.
• Refer to the WARNINGS chapter (4) to verify any special care to exercise before
starting to use the device.
• When opening the package and prior to installation, check the device for
completeness. Report any damage sustained during shipping or any missing parts to
your retailer within 24 hours of receipt of the device.
• Ambient Conditions for Operation.
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34
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Содержание Apica Pro
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