Safety Designation Per Iec 60601-1 - Micro Direct MicroLab Operating Manual

Safety Designation per IEC 60601-1

Type of protection against electrical shock
Degree of protection against electrical
shock
Power Equipment
Degree of Electrical connection between
equipment and patient
Degree of mobility
Mode of operation
Classifications according to IEC 60601-1
MicroLab
Volume Transducer
WARNING: No modification of this equipment is allowed.
Note: When you connect other equipment to the unit, always make sure
that the whole combination complies with the international safety
standard IEC 60601-1 for medical electrical systems. During
measurements, connect the MicroLab only to printers and computers that
comply with IEC 60601-1 / ANSI/AAMI ES60601-1:2005 /CAN/CSA-
C22.2 No. 60601-1:14.
WARNING: The user must not touch any voltage carrying parts and the
patient at the same time.
During database upload, the MicroLab may be connected to a computer
that complies with EN 60950 – 'Information technology equipment –
Safety – Part 1: General requirements'.
IMPORTANT: Only use the mains adapter supplied (PSU1012 12V DC
2.5A). The adapter contains a transformer. Do not cut off the adapter to
replace it with another plug as this causes a hazardous situation.
• The adapter transforms the mains voltage (100-240 Volts) to a
safe voltage (12V DC)
• Make sure the adapter does not get wet
• Do not use a damaged adapter
• Always unplug your MicroLab before cleaning
WARNING: Do not connect devices that are not specified as part of the
system.
Internally powered
Equipment and Class I
Type B applied part
Battery type: NiMH battery
pack, 8.4V, 1100mAh
Equipment designed as
non-electrical connection
to the patient
Transportable
Continuous
Applied part, type B
Applied part, type B
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