EN
OwandyCam – User Manual
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1 Introduction
You have just received your
OwandyCam
intraoral imaging set. We thank you for the confidence you have
placed in us and hope that this product will provide you a complete satisfaction.
We advise you to read this manual carefully prior to installation. Observance of the use and installation
precautions in this document removes risks to the patient and for the care team. Please keep it with your
equipment so that you can refer to it later.
Your intraoral camera is a new generation of digital imaging equipment with USB2 connection. With its
ergonomic design and tailored shape, it enables you to obtain quickly and simply a perfect and clear image
of the endobuccal cavities of your patients. This equipment does not involve backup on a flash memory card,
so avoiding any loss of quality due to compression. Therefore, the USB2 connection enables images to be
transferred and integrated directly into your image processing software, without even relying on an external
power supply box or built-in battery.
1.1 Compliance with regulations
The
OwandyCam
unit is a class I medical system in accordance with European Directive 93/42/CEE relating
to EC branding. It is also a class I type BF system under the terms of regulation EN/IEC60601-1.
The
OwandyCam
is, therefore in compliance with that directive and that regulation, as also with regulation
EN/IEC60601-1-2 regarding electromagnetic compatibility.
Under certain conditions (see paragraph “1.3 Installation precautions”) is necessary for any other
components of the system connected (computer and optional peripherals) also to be in compliance with
regulation CEI950 (EN60950) and that the installation is in compliance with regulation EN/IEC60601-1.
1.2 Power supply
The power supply for the handpiece which lights the 6 LEDs is assured via the USB connection linking it to
the computer, i.e. by a 5V DC supply.
1.3 Installation precautions
The regulations require that your computer is at least in compliance with regulation CEI/EN60950-
1. If you have a Class 1 computer, see that its earth is connected to the building’s earth.
As the handpiece of the
OwandyCam
is located in the patient environment (less than 1.5 metres / 4.9 feet
from the patient), it is imperative that your computer complies with regulation EN/CEI60601-1, or that your
installation including the computer has been made compliant with regulation EN/CEI60601-1. When your
whole installation is in compliance with regulation EN/CEI60601-1, you can then connect the box to your
computer without further precautions being necessary.
If the computer is not located in the patient environment and is not in compliance with regulation
EN/CEI60601-1, it is imperative to insulate the handpiece from the patient by placing it in a non-conducting
envelope (hygienic covers).
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