2.2 Specifications
25
BF-190 Series OPERATION MANUAL
Ch.2
Medical Devices Directive
This device complies with the requirements of Directive 93/42/EEC
concerning medical devices.
Classification: Class II a
EMC Applied standard IEC 60601-1-2: 2001
IEC 60601-1-2: 2007
• This instrument complies with the EMC standard for medical
electrical equipment, edition 2 (IEC 60601-1-2: 2001) and
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 B
Year of manufacture The last digit of the year of manufacture is the second digit of the
serial number. In this example, the year is 2013
.
Ex. 2301234 (serial number)
Degree of protection against electric shock TYPE BF applied part
Ingress protection rating IPX7
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