The original text is in Italian; this is a translation from the original in Italian.
This User’s manual refers to both the ZEN-X and ZEN-Xi systems (indicated as “the sensor”, “the digital
sensor”, or “the device” to mean the same), providing specific details only when there are differences
between the two versions.
The manual refers to a “computer”, Personal Computer, “work post”, WorkStation or WS indifferently. In all
cases, the computer used will have to satisfy the technical requirements indicated.
1.2. GENERAL WARNINGS
Please pay particular attention to the sections in the manual where the following symbols appear:
Patient or operator safety-related warnings.
Important information on product use.
The ZEN-X / ZEN-Xi sensor and the relevant software iCapture are developed and manufactured by Cefla S.C. – Via
Selice Prov.le 23/A 40026 Imola (Italy), hereinafter referred to as the Manufacturer, which is the manufacturer and
distributor in compliance with the EC Medical Device Directive.
WARNING: These instructions explain how to correctly use the ZEN-X / ZEN-Xi sensor. As regards the
iCapture software instructions, consult the specific manual. Carefully read
both manuals before attempting to use the sensor and program.
In order to use the ZEN-X / ZEN-Xi sensor, software for capturing and saving the images is needed that is not part of
the ZEN-X / ZEN-Xi sensor. Consult the relative manual for information about installation and use of the image
management software.
- The contents of this publication are valuable trade secrets and must not be given to third parties, stored, copied,
reproduced, disclosed or transferred in any manner (via computer, photocopies, translations or other means)
without the prior written consent of the Manufacturer.
- The Manufacturer pursues a policy of continual improvement of its products; therefore, some specific instructions
and images contained in this manual may differ from the product purchased.
- The Manufacturer reserves the right to make changes without prior notice.
- The information, technical specifications and illustrations contained in this publication are not binding. The
Manufacturer reserves the right to make technical modifications and improvements without modifying these
instructions.
- All the registered trademarks and the product names mentioned are the property of the respective owners.
- Carefully read the USER LICENSE AGREEMENT before using the product. When installing the program, you will
explicitly be asked to accept the agreement; if you do not accept, the program cannot be installed.
WARNING: In accordance with privacy laws in force in several countries, all sensitive personal information
must be adequately protected. In addition, patients must sign a consent form before personal information or
images are transmitted across networks. If required by the laws in force, dentists are obliged to protect data
using a protection password. Refer to the Microsoft® Windows operating system manual for data access
protection methods by means of password.
It is recommended to regularly (at least once a week) make a backup copy of the databases. This will allow
restoring the data in the event of damage to the hard disc of the PC or the databases themselves.
1.3. STANDARDS AND REGULATIONS
The sensor was designed to meet the requirements of Directive 93/42/EEC as amended (namely Directive
2007/47/EC) concerning Medical Devices, based on which it is classified as class IIa medical device.
The CE marking certifies compliance of the product as described herein with Medical Device Directive
93/42/EEC and subsequent amendments.
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