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ONE – User manual Page 6/44
1.3 Application environments
One kit may be used in dental practice environment.
One may be used in professional buildings or in residential buildings. For the purpose of EMC environment
classification, both installations are classified as “Professional healthcare facility environment and Home healthcare
environment”.
1.4 Applied parts
During normal use, One sensor is in contact with the patient via intraoral sensor and part of cable near to the sensor.
The intraoral sensor and cable are inside a protective sheath during use .These parts are classified as Type BF applied
parts.
1.5 Frequency of use
The maximum duration of use correspond to 10 minutes. It’s very probable that for a given patient, total contact
will not exceed one hour in patient lifetime
1.6 Prescription Use Statement
Caution: Federal law restricts this device to sale by or on the order of a dentist or any other practitioner licensed by
the law of the State in which he practices to use or order the use of the device
1.7 Compliance with standards
The ONE kit is class IIa equipment within the meaning of the European Directive 93/42/CEE concerning CE markings.
The ONE kit complies with the IEC60601-1, IEC 60601-1-6, IEC 60601-1-2 and IEC62304 medical devices standards.
It is necessary that the other components of the system that are possibly connected (computer and optional
peripherals) are compliant to standard IEC60950-1
The intra-oral sensor is contained within a hermetic and sealed case (resistant to immersion). There is no physical
or electrical connection between the ONE kit and the X-ray generator.
1.8 Power supply
The power to the ONE box is provided directly by the power supply of the USB cable connecting it to the computer. For the
procedure for switching the device ON and OFF refer to the computer instructions
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