Safety Designation Per Iec 60601-1 - Vyaire MicroRPM Operating Manual

Safety Designation per IEC 60601-1

Type of protection against
electrical shock
Degree of protection against
electrical shock
Power Equipment
Battery life:
Degree of Electrical connec-
tion between equipment and
Patient
Degree of mobility
Mode of operation
Classification according to IEC 60601-1
Respiratory Pressure Meter
WARNING: No modification of this equipment is allowed.
WARNING: Do not connect devices that are not specified as part of
the system.
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 MicroRPM only to computers that
comply with IEC/EN 60601-1 / ANSI/AAMI ES60601-1:2005.
WARNING: The user must not touch any voltage-carrying parts
and the patient at the same time.
Internally powered Equipment
Type B applied part
Battery
2000 tests.
Equipment designed as non-
electrical connection to the
patient.
Transportable
Continuous
Applied part, type B
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