5
Symbols interpretation
Safety Test Standards:
Medical Devices Directive 93/42/EEC
IEC 60601-1:2005+A1:2012/EN 60601-1:2006 Medical electrical equipment - Part 1: General
requirements for basic safety and essential performance
IEC 60601-1-2:2007/EN 60601-1-2:2007 Medical electrical equipment - Part 1-2: General
requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and
tests
IEC 60601-2-10:2012/EN 60601-2-10:2000+A1:2001 Medical electrical equipment - Part 2-10:
Particular requirements for the safety of nerve and muscle stimulators
IEC 60601-1-11:2010 Medical electrical equipment -- Part 1-11: General requirements for basic
safety and essential performance -- Collateral standard: Requirements for medical electrical
equipment and medical electrical systems used in the home healthcare environment.
EN 980 Symbols for use in the labeling of medical devices
EN 1041 Information supplied by the manufacturer with medical devices
IEC/60601-1-6/ EN 60601-1-6 Medical electrical equipment – Part1-6: General requirements for
basic safety and essential performance – Collateral standard: Usability
Fragile, handle with care
Type BF applied part
Keep the product in the dry
place
Away from water and rain.
CAUTION, Avoid injury.
Read and understand owner’s
manual before operating this
product.
This way up
Manufacturer
Product package should be
recycled.
Symbol for "AUTHORISED
REPRESENTATIVE IN THE
EUROPEAN COMMUNITY"
Unrecyclable
Batch code
Date of manufacture
FDA
510(k)
FDA 510(k) cleared
Serial number
IP22
IP code of the device