Regulatory Requirements - suni SuniCam II Bedienungsanleitung

REGULATORY REQUIREMENTS

COMPLIANCE WITH STANDARDS AND REGULATIONS
This product was designed and manufactured by a company having an
authorized quality system. It meets the requirements of the European directive
93/42/EEC, relative to medical devices. Therefore, it particularly meets
electrical safety and electromagnetic compatibility standards (IEC) (CEM).
ELECTROMAGNETIC INTERFERENCE AND ELECTROSTATIC DISCHARGES
Electromagnetic compatibility (CEM) is the ability of electronic device elements
to correctly interact in an electronic environment. Although this dental camera
system was designed according to this compatibility and complies with the
electromagnetic interference thresholds established by the regulatory agency,
there is no guarantee about the interference likely to occur on a particular
installation.
If the device generates interference with radio communication services (which
can be determined by switching it off and on), the user is recommended to try
to correct this phenomenon by taking whole or part of the following measures:
• Change the receiving antenna orientation.
• Reposition the product according to the receiver.
• Take away the computer from the receiver.
The SuniCam II dental camera system is designed and tested to be used in a
home environment, class B Group 1, according to CISPR11 standard.
MEDICAL DEVICE VIGILANCE
The intraoral dental camera is considered a medical device, which is subjected
to the medical device vigilance dispositions; any serious dysfunction should
then be the subject of a description to the competent authorities and to the
manufacturer as soon as possible and as precisely as possible.
END OF LIFE
This device bears the recycling symbol according to the European directive
2002/96/EC about electric and electronic equipment waste (DEEE or WEEE).
Properly disposing of this device will contribute to avoiding any damage done to
the environment or human health.
This symbol present on the device or on the accompanying
documentation indicates this product cannot be in any way treated
as household waste. Therefore, it should be given to a waste
collection agency in charge of electric and electronic equipment
recycling.
For more details relative to scrapping, recuperation and recycling,
of device, contact Suni. In addition, check with the appropriate
local, state or country offices for instructions specific to your area.
Always respect the standards and regulations in force in your area.
SCLS-267 Rev A SuniCam II International User Guide Part# 900-0632 29 Dec 2008
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