18
2.3 Specifications
TB-0545PC/IC/FC, TB-0535PC/IC/FC, TB-0520IC, TB-0510IC
INSTRUCTION MANUAL
Ch.2
Medical Devices Directive
This device complies with the requirements of Directive 93/42/EEC
concerning medical devices.
Classification: Class II b
EMC Applied standard IEC 60601-1-2: 2007
• This instrument complies with the EMC standard for medical
electrical equipment; edition 3 (IEC 60601-1-2: 2007). However,
when connecting to an instrument that complies with the EMC
standard for medical electrical equipment, edition 1
(IEC 60601-1-2: 1993), the whole system complies with edition
1.
• CISPR 11 of emission:
Group 1, Class A
Year of manufacture Indication The last digit of the year of manufacture is the second digit of the
lot number. In this example, the year is 2010.
Ex. K0
123 (lot number)
This device complies with the requirements
of Directive 93/42/EEC concerning medical
devices.
Classification: TYPE CF applied part electromedical equipment.
The degree of protection against electric shock of this instrument
depends upon the electromedical equipment employed. Refer to
the particular unit and its instruction manual.
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