Section XI: Symbols
CE marking of conformity
Manufacturer
Date of manufacture
Authorized representative in
the European Community
Type BF equipment
Consult instructions for use
Autoclavable up to 135 °C
Section XII: Specifications
Classifications
Type of protection against electric shock:Class I
Degree of protection against electric shock:Type BF
Mode of operation:Intermittent (5 min on/10 min off)
According to medical device directive:IIa
Complies to following Directive/Standards
EN/ISO13485:
EN/IEC 60601-1:
EN/IEC 60601-1-2:
Medical Devices, Quality Management Systems, Requirements for
regulatory purposes
Medical Electrical Equipment, General Requirement for Safety
Medical Electrical Equipment, Electromagnetic Compatibility,
Requirements and Tests
- 20 -
Fragile; handle with care
Keep dry
This side up
Requires immediate attention
Serial number
Illumination, LED