Indications For Use; Contraindication; Warnings - Coxo C-SMART-1 Pro User Manual

C·SMART· IPro

2 Indications for use

The device is the supplementary root-canal treatment device which can assist
the dentists to shape more standard root-canal in the process of root-canal
treatment based on the micro-electronic control technology. This instrument
contributes to alleviate the dentist's working intensity.
This device must only be used in hospitalenvironments, clinics or dental offices
by qualified dental personnel.
3 Contraindication&
In cases where a patient has been fitted with an implanted heart pacemaker
o
(or other electrical equipment) and has been cautioned against the use of small
electrical appliances (such as electric shavers, hair dryers, etc.) it is
recommended not to use the device.
The device should not be used for severely curved root canal preparation.
o
Do not use the device for implant or any other dentist procedure outside
o
endodontics.
f4

Warnings

The device must only be used in suitable locations and only by specialized
physicians licensed to practice dentistry.
In this chapter, a description of serious adverse reactions and potential safety
hazards for the product or the user/patient is included.
Read the following warnings before use.
WARNINGS
The device must only be used in suitable locations and only by specialized
o
physicians licensed to practice dentistry.
Confirm that the operating voltage and the mains voltage are compatible.
o
• Use the specified battery for this product. Never use a battery other than
those specified by manufacturer.
Use the manufacturer AC adapter for this product. Never use any other AC
o
adapters.
If you do not use the device for a long period of time,remove the battery to
o
avoid fluid leak.
If you should notice battery fluid leak, deformation of the motor handpiece
o
casing or partial discoloring, immediately stop use and contact your distributor
II
Usar Manual C-SMART-1 Pro User Manual
Then remove the accessories from the disinfection bath and rinse them
o
thoroughly with water for at least five times for 1 min.and press and release
the file clip five times. Inspect, dry and pack the accessories as quickly as
possible after removal(see chapter INSPECTION, and PACKING).Please
make sure that the accessories do not have direct contact.
9.2.3 Inspection/Maintenance
Check all accessories after cleaning or cleaning
accessories should be immediately discarded. These defects include:
• Plastic deformation
·Corrosion
Accessories which are still contaminated must be cleaned and disinfected again.
Maintenance is not required. Instruments oil must not be used.
9.2.4 Packing
Please pack the accessories into disposable Sterilization packages (single
disposable packaging) meeting the following requirements:
•Compliant with DIN EN ISOIANSIAAMIISO 11607
·Suitable for steam Sterilization
9.2.5 Sterilization
Use only the Sterilization methods listed below; other Sterilization methods are
not permitted.
• Steam Sterilization
• Fractional vacuum/pre-vacuum (at least three vacuum cycles) method or
gravity displacement method (product must be sufficiently dry).
The less effective gravitational method should only be used if the fractional
vacuum method is not available.
·Steam sterilizer according to DlN EN 13060 or DIN EN 285.
·The Sterilization validation has been performed in compliance with DIN EN
ISO 17665 (Valid installation and operation qualification (IQ and OQ) and
product-specific performance qualification (PQ).
• Maximum Sterilization temperature 134
according to ISO DIN EN ISO 17665.
·Sterilization time (exposure time at Sterilization temperatura) at least
•c
18 min.at 134 (273 aF).
I disinfection. Defective
ac
GF);
(273 plus tolerance