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Vathin DVM-A2 - Applicable Standards

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6
Caution
When advancing or retreating a Vathin endoscope, always watch the real-time endoscopic image on the
monitor connected to the product. You should carefully check whether the image on the screen is a
real-time image or a video record, and check that the direction of image meets the expectations.
The use of accessories other than the accessories, sensors or cables specified or provided by the
manufacturer of the product may increase the electromagnetic radiation or reduce the electromagnetic
immunity of the product, and cause improper operation.
When using any portable radio frequency communication equipment (including antenna cables, external
antennas and other peripheral equipment), such equipment should not be placed over 30 cm (12 inches)
away from any part of the product, including the cables specified by the manufacturer; or else, the
performance of such equipment may be impaired.
Do not connect or disconnect the endoscope connector when the product is started; or else, the
endoscope may be damaged.
Do not use any sharp object to operate the screen of the product; or else, the screen may be damaged.
Never apply excessive force to the connector; or else, the product may be damaged.
Always prepare an applicable and immediately available standby system to ensure that treatment
procedure can be continued in the event of equipment failure.
Always keep the product dry when preparing, using and storing it.
Always use the spare parts provided by Vathin Medical. Never refit any spare part.
Always place the power cable in the place where it is unlikely to be stepped on. Do not place any objects
on the power cable.
The real-time imaging of the product may be affected by the use of high-frequency tools inside the
connected endoscope. This phenomenon is not a malfunction. In such a case, just wait a few seconds to
reset the image.
The product is not repairable. In case that the product becomes defective, it should be discarded.
In case of any serious accident arising out of the use of the product, please report it to both the manufacturer
and the competent authority of your country.
Applicable Standards
The Vathin
®
Digital Video Monitor meets the following standards:
- REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on
medical devices
- IEC 60601-1 Medical electrical equipment - Part 1: General requirements for basic safety and essential
performance
- IEC 60601-1-2 Medical Electrical Equipment - Part 1–2 General requirements for basic safety and essential
performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests

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