Myray ZEN-X - 1. Introduction and Indications for Use; 1.1. Description of the Manual

EN
OPERATOR'S MANUAL
3
1. INTRODUCTION AND INDICATIONS FOR USE
ZEN-X / ZEN-Xi are digital intraoral sensors intended for acquiring intraoral digital images when exposed to X-rays,
for diagnostic radiographic examination of the human dentition (teeth, maxillary area and oral structures).
The produced digital images are automatically transmitted via digital connection to a PC.
The devices can be used as accessories to legally marketed components such as conventional X-ray tubes and
software for the acquisition of images.
The devices are managed and used by doctors, dentists, radiologists and other legally qualified professionals.
The intraoral sensor ZEN-X / ZEN-Xi has been developed to simplify the entire intraoral x-ray acquisition procedure
and display the images on a computer screen. Thanks to the new shape ergonomics, these sensors allow an easy
intraoral positioning. The smoothed edges and rounded corners comfortably adapt to the shape of the patient’s
mouth, ensuring an easy positioning. ZEN-X / ZEN-Xi sensors are available in two interchangeable sizes to satisfy
various diagnostic requirements.
The sensor electronic module is compatible with the extremely fast USB
®
2.0 standard, thereby cutting down the time
that elapses between x-ray exposure and display of the image on the computer screen to a few seconds.
- ZEN-X is designed as a portable device (stand-alone);
- ZEN-Xi is constructed to be integrated in dental units that are mechanically compatible.
In ZEN-X, the USB
®
connection makes the system convenient and portable. In fact, no power supply adapters are
needed as power is fed directly through the USB
®
port, thanks to the low consumption requirements.
In ZEN-Xi, the X-ray sensor is placed on-board the dental unit like any other instrument on the dentist’s board.
A computer and program to view x-ray images are required for use of both versions. If used in conjunction with a
dental office practice management software, the x-ray images can be associated to each patient and saved for
processing and viewing when required.
The sensor system makes use of a communication standard called TWAIN
®
, adopted by many electronic products
such as scanners and digital cameras. TWAIN
®
ensures product compatibility with all the best programs for digital
image management and processing.
Regardless of the selected program, refer to the manual supplied together with the program for all the warnings,
precautions and operating instructions.
The sensor is supplied together with software called iCapture, that assures the x-ray images are correctly transferred
from the electronic module to the computer.
USA federal law restricts this device to sale by or on the order of a licensed healthcare practitioner.
Use a third-party software for the management and treatment of digital images acquired with the intraoral
sensor only as long as such software does not alter the content of the images provided by iCapture
independently from the user's will.
The Manufacturer’s website contains a list of authorised agents.
1.1. DESCRIPTION OF THE MANUAL
This Manual is an essential consultation tool and contains important information and instructions for the use
of the digital sensor.
These instructions describe how to properly and safely use the sensor.
Carefully read and familiarise yourself with the entire contents of the Manual before attempting to use the
product.
To use the software, refer to the specific manual.
The Manual is only provided in electronic format and can be consulted directly on the PC screen during use.
It is advisable to keep a copy of this manual within reach with the aim of training the operators and as guide
for consultation during the use of the device. This manual also contains all the essential information for the
safety of patient, operator and device.
It is therefore advisable to read carefully the paragraphs on the safety rules.