Safety Designation Per Iec 60601-1 - CareFusion Spiro USB Manual De Funcionamiento

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/EN 60601-1 / UL
60601-1.
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.
WARNING: Do not connect devices that are not specified as part of
the system.
WARNING: To avoid risk of electric shock, this equipment must
only be connected to supply mains with protective earth.
Powered by computers that
comply with IEC/EN 60601-1 /
UL 60601-1.
Type B applied part
Powered by computers that
comply with IEC/EN 60601-1 /
UL 60601-1.
Equipment designed as non-
electrical connection to the
patient.
Transportable
Continuous
Applied part, type B
Applied part, type B
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