Safety Designation Per Iec 60601-1 - Micro Direct MicroLoop 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
MicroLoop
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 MicroLoop only to
printers and computers that comply 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.
Shaft of the
syringe is being
pushed down
26
The syringe should be
emptied and filled with
one smooth stroke,
avoid pushing down on
the shaft or banging at
the end of each
maneuver
Internally powered
Equipment and Class I
Type B applied part
Battery type: Lithium
ion polymer LP385085,
3.7V, 1600mAh
Equipment designed as
non-electrical
connection to the
patient
Transportable
Continuous
Applied part, type B
Applied part, type B