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PHYSIOMED ELEKTROMEDIZIN AG
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3.4 General Notes
DEEP OSCILLATION
IIa according to the Medical Devices Regulation (2017/745).
It is not intended for operation in explosion hazard zones or hydrotherapy rooms. Drastic temperature
changes should be avoided, since condensation could be caused within the device. Do not start up the
device until it is in thermal equilibrium with its environment!
The device may only be operated by intended users, and only in accordance with the Operating Instruc-
tions. Operating the device in the proximity (e.g. 1 m) of a short-wave or micro-wave therapy unit may
cause output irregularities and should be avoided for this reason, as well as simultaneous connection of
the patient to high-frequency surgical device.
The device must be stored in a way so that dust and particles cannot enter the ports. The device must be
protected from falling down.
The device must not be stored or operated at elevated temperatures. Direct exposure to sunlight must be
avoided. The maximum temperature for operation is 40°C. For every degree of excessive temperature,
three minutes time for accommodation have to be assumed as a guideline.
CAUTION
Technical modifications to the device are not admissible and will inevitably lead to loss of ap-
proval as a medical device.
The assembly of medical electrical systems (ME systems) and their modification during their ef-
fective service life require verification of the compatibility with the standard for ME systems
(EN60601-1, 3rd Edition) by the responsible organization (system builder).
Any serious incident that occurred when operating DEEP OSCILLATION
ported to PHYSIOMED ELEKTROMEDIZIN AG and to the responsible authorities of the respect-
ive country.
3.5 Essential Performance
The essential performance is a pulsed electrostatic field output for a massage/deep oscillation effect.
6
Meaning
Follow operating instructions
Do not charge during treatment! To charge, only use the supplied power adapter
(Ref no. 55965).
®
Personal complies with the technical standard IEC 60601-1, and is assigned to class
3 Introduction
®
Personal has to be re-
®
DEEP OSCILLATION
Personal

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