Chapter 1 - Introduction; Essential Performance - KaVo IXS Benutzerhandbuch

Chapter
1
This User Manual contains original instructions by KaVo for safe set-up, use and
maintenance of the KaVo IXS. The user must be able to read and understand the
written language of the manual.
It also contains technical specifications of the system and basic information on how
the system works. Carefully follow setup, assembly and alignment procedures,
defined in this manual, to ensure quality image captures of defined areas of the
patient's anatomy.
Please read this manual carefully before starting to use the device, paying particular
attention to warnings, especially safety warnings. Operators are strongly urged to
comply with the current recommendations of the International Commission on
Radiological Protection and, in the United States, the US National Council for
Radiological Protection.

Essential Performance

WARNING
No modification of this equipment is allowed.
The essential performance of the KaVo IXS sensor system comprises:
The ability of the sensor to capture X-ray images suitable for
•
recognition of normal anatomical structures, dental pathologies,
and abnormal conditions, where inadequate images may result in
mis-diagnosis, subjecting the patient to incorrect or unnecessary
dental procedures that would present an unacceptable risk to the
patient;
The ability of the sensor holder to align the sensor with the X-ray
•
source for imaging the desired anatomy.
The ability of the single use sensor sheaths to isolate the sensor
•
from the patient, where cross-contamination could present an
unacceptable risk to the patient.
English
Introduction
1-1