Medical Devices Directive
EMC
Applied standard
Year of manufacture
Degree of protection against electric shock
Ingress protection rating
BF-190 Series OPERATION MANUAL
This device complies with the requirements of Directive 93/42/EEC
concerning medical devices.
Classification: Class II a
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
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)
TYPE BF applied part
IPX7
2.2 Specifications
Ch.2
25