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
SpiroUSB
Volume Transducer
WARNING: No modification of this equipment is allowed.
CAUTION: 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 SpiroUSB 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 or the operator must not create
a "bridge" between the device I/O ports and the patient by
simultaneously touching both.
Powered by computers that
comply with IEC 60601-1 / ANSI/
AAMI ES60601-1:2005 / CAN/
CSA-C22.2 No. 60601-1:14.
Type B applied part
Powered by computers that
comply with IEC 60601-1 / ANSI/
AAMI ES60601-1:2005 / CAN/
CSA-C22.2 No. 60601-1:14.
Equipment designed as non-
electrical connection to the
patient.
Transportable
Continuous
Applied part, type B
Applied part, type B
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