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.
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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