Symbols; Symboles; Zeichenerklärung - IGEA I-ONE User Manual

IGEA

11. SYMBOLS

Class II device: protection against direct contact consists not only of basic insulation, but also of
additional safety measures for double insulation.
The device has a BF-type applied part: the device has a specific degree of protection against electrical
hazards, with particular regard to permissible leakage currents, and an F-type applied part (floating)
isolated from all other parts of the device (Coil).
Direct current: the symbol shown on the nameplate of the external power supply indicating the type
of power supplied to the generator.
Alternating current: the symbol indicating the type of power supply required from the external power
supply.
Warning - consult accompanying documentation: this symbol informs the user that they need to
check the documentation supplied with the device, including the user manual, for a correct
understanding and/or use of the part marked with the symbol.
Follow operating instructions: this symbol tells the user that the operating instructions must be read
before starting to use the device.
Name and address of the manufacturer: Manufacturer's identification details; next to the symbol
are the name and address of the manufacturer
Date of manufacture: the year of manufacture is shown next to the symbol
IP rating: this symbol informs the user that the device offers a certain degree of protection against
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the penetration of dust and liquids.
Serial number: this symbol shows the serial number.
Medical device: the symbol identifying the device as medical grade
Catalogue number: the symbol associated with the product catalogue number assigned by the
manufacturer
UDI code: A two-dimensional code used to enter all the required information in accordance with
the UDI (Unique Device Identification) coding system
Model code identifier of a single medical device
Separate collection and recycling of batteries: battery elements are subject to a separate collection
for recycling.
Separate collection: IGEA devices and their applied parts cannot be disposed of as municipal waste
but are subject to a separate collection in accordance with the procedures established by the local
authorities.
CE Marking symbol: the device complies with Medical Device Regulation MDR 2017/745 of the
European Union. The number following the CE mark is the identifier of the Notified Body that
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performs the conformity check with the MDR to enable the mark to be affixed to the product.
Atmospheric pressure limits for transportation and storage: the symbol on the outer packaging of
the device.
Relative humidity limits for transportation and storage: the symbol on the outer packaging of the
device.
Relative temperature limits for transport and storage: the symbol on the outer packaging of the
device.
Handle with care: the symbol on the outer packaging of the device.
Transportation packaging must be kept out of the rain and in dry conditions
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