Myray ZEN-X - 1.6. General Safety Warnings; 1.6.1. Installation Conditions; 1.6.2. Conditions of Use

EN
OPERATOR'S MANUAL
7
necessary to install the sensor with longer cables, a USB
®
repeater must be compulsorily installed every
4.5m, and for a maximum of three cable sections (two repeaters).
WARNING: The sensor used to capture images is fragile and bothered by
electrostatic discharges. Handle it with care. Do not deform or squeeze it. Do not touch the electric contacts
when the connector is not plugged into the electronic control module.
Do not disconnect it while the interface is on; see paragraph 3 “DESCRIPTION OF OPERATION”.
1.6. GENERAL SAFETY WARNINGS
The instructions inform the user on how to properly operate the system. Read this manual thoroughly before
using the device.
The owner or manager of the installation site is responsible for verifying the compliance with local requirements
and/or requesting advice from a Qualified Expert. Pay special attention to compliance with legal obligations regarding
the protection of workers, the population and patients from radiation.
The main regulations are listed in this manual (1.3 - Standards and Regulations).
Do not use the system for tasks other than described as intended use (1 – Foreword and instructions for use), and do
not use it if you are not an expert in dentistry and radiology.
Law restricts sale and use of this device only to doctors, dentists or radiologists.
USA federal law restricts this device to sale by or on the order of a licensed healthcare practitioner.
1.6.1. INSTALLATION CONDITIONS
- The system must not be used if it shows any electrical or mechanical defect. Like for all medical electrical
systems, this device requires proper installation, use, maintenance and service with the aim of assuring safe
and efficient operation.
- For Europe, the electric system in the room where the device is installed must comply with the IEC 60364-7-
710 standards (requirements for electric systems in rooms used for medical purposes).
- Before installing the sensor software and drivers, ensure that programs using TWAIN® for image
management (cameras, digital cameras, scanners) are installed on the personal computer. Keep in mind that
any system drivers installed may interfere with operation of the programs and vice versa.
- It is recommended to use a dedicated computer for the device. This computer should be used only as a work
tool and any software programs that are not needed should be uninstalled.
- In order to use the device, the sensor software components have to be installed. Consult the iCapture
manual and refer to the relevant instructions.
- If the ZEN-Xi sensor is integrated in Manufacturer's dental chairs equipped with an incorporated Workstation,
no installation procedures are required as all the drivers and software needed are factory-installed.
For further details, refer to the installation template and the detailed instructions given in the service manual.
1.6.2. CONDITIONS OF USE
The equipment may only be used by authorised and adequately trained staff (physicians and paramedics).
Comply with all safety use requirements:
- Do not forget to turn off the main switch on the equipment before leaving the surgery.
- The equipment is not suitable for use in the presence of a mixture of flammable anaesthetic gas with oxygen
or nitrous oxide.
- This equipment must be stored properly so that it is kept in top working order at all times.
- The user must be present at all times when the equipment is turned on or ready for start-up. In particular,
never leave the equipment unattended in the presence of children or other unauthorised personnel in
general.
- The Manufacturer shall not be held responsible (under civil and criminal law) for misuse, carelessness or
improper use of the equipment.
- If any person who is not an authorised technician changes the product in any way by replacing parts or
components with other ones not used by the Manufacturer, they shall assume responsibility for the product.
Do not tamper with the equipment unless authorised by the Manufacturer.