PFA-100 System – Instruction Manual (US) – Version 1.0.1
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2.4 Meaning of the warning and information symbols on the analyzer
2.5 Statutory requirements
International standards The analyzer complies with the following directives:
• 73/23/EEC Low-Voltage Directive
• 89/336/EEC EMC Directive
The PFA-100 System has been designed and tested to comply with safety
standards EN 61010 and IEC 61010 under the conditions listed in
Chapter 6.3.
Electromagnetic compatibility
(EMC)
The basis for the test is EN 61326 or IEC 61326. The analyzer has been
developed and tested according to EN 61326-1 class A.
2.6 Obligations of the system owner
The system owner takes on the obligations arising from the national
legislation about the operation of in vitro diagnostic medical devices.
General warning which draws the user’s attention to particular potential
hazards.
This label certifies that the analyzer has been tested according to Canadian
and US safety standards by the nationally recognized testing laboratory TÜV.
Biohazard
The marked area of the analyzer can come into contact with potentially
infectious material.
The safety instructions for working with infectious material must be followed.
Table 2-1 Warning and information symbols
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