Classification Of Equipment; Operation Principle; Symbol - NSK iPex II Manual De Operación

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Classification of Equipment
●
Type of protection against electric shock :
-Internally powered equipment
●
Degree of protection against electric shock :
-Type BF applied part (Applied part: File clip and Lip hook)
●
Method of sterilization or disinfection recommended by the manufacturer :
-See '9-2 Sterilization of file clip and lip hook'
●
Degree of protection against ingress of water as detailed in the current edition of
IEC 60529 :
-Control Unit...IPX0
●
Degree of safety of application in the presence of a flammable anesthetic mixture
with air or with oxygen or nitrous oxide :
-Equipment NOT suitable for use in the presence of a flammable anesthetic
mixture with air or with oxygen or nitrous oxide.
●
Mode of operation :
-Continuous operation
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Operation Principle

The lip hook and file clip as electrodes are attached to the patient's mouth and the
operation instrument such as a file, respectively. And the motion of the instrument
end in the root canal causes an impedance variation between the pair of electrodes.
The position of the apical foramen is detected by measuring the impedance variation
using two different frequencies.
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Symbol

TUV Rhineland of North America is a Nationally Recognized Testing Labora-
tory (NRTL) in the United States and is accredited by the Standards Council
of Canada to certify electro-medical products with Canadian National
Standards.
Conforms to CE European Directive of "Medical equipment directive 93/42/
EEC."
Type BF applied part.
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