Classification; Safety Instructions - Soehnle 7730.65.001 Mode D'emploi

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areas designated for medical use. ATEX zones can be created by using combustible anesthetics,
skin cleaning agents, and skin disinfectants.
The scale must only be operated by staff. The scale is not intended for operation by the
patient.

3.3 Classification

Class I Medical Device with measurement function.
Class II Electrical Protection (insulation protected, no protective ground conductor).
Water protection iaw. EN60529: IPX2 for the entire unit.
Application device
The medical device is a Type B application device and is intended for direct
contact by the patient. The leakage currents meet the classification for Type B application
devices.

3.4 Safety instructions

This device is intended strictly for professional use. Before operating the device, please
read the information shown in the user manual with care. These contain important
information about the installation, the intended uses, and maintenance of the device.
The manufacturer is not liable if the following instructions are not observed: When using
electrical components under elevated safety requirements, the corresponding regulations must
be adhered to.
Use in critical and explosive environments is not intended (CT, defibrillator). In mains mode, the
display device must be positioned to ensure that the display can be easily disconnected from
the electrical mains (ensure accessibility of the power outlet). Do not allow the display and the
scale to get wet.
Reposition the scale by lifting and not dragging it across the floor. Then verify level alignment
and adjust as needed.
This device is radio interference suppressed law. The applicable EC Directive is 2014/30/EU.
However, the reading can be influenced under extreme electrostatic and electromagnetic
interference, e.g. when operating a radio transmitter or mobile telephone in the immediate
vicinity of the device. Following the end of the interference, the product can again be used as
intended; it may have to be switched back on. Contact your designated service partner if the
electrostatic interference is permanent in nature.
The device is a measurement instrument. Airflow, vibrations, rapid temperature changes
and sun exposure can influence the weighing result.
The scale meets IPX2 protection class requirements. High relative humidity, vapors, aggressive
fluids, and significant dirt buildup must be avoided.
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7730.65.002

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