Reference guidelines
15.
The instrument is compliance with the below guidelines::
•EN12470-5 and ASTM E1965-1998
•EN980:
Graphical symbols tor use in the labeling of medical devices
• EN1041:
Information supplied by the manufacturer with medical
devices
• EN60601-1:
Medical electrical equipment Part 1: General requirements
tor safety (IEC:60601-1
•EN60601-1-2:
Medical electrical equipment Part 1-2
requirements tor safety Collateral standard Electromagnetic
compatibility Requirements and test (IEC
EMC Directive
This device has been tested and homologated in accordance with
EN60601-1-2:2007 tor EMC. This does not guarantee in any way that
the device will not be affected by electromagnetic interference. Avoid
using the device in high electromagnetic
The MEDICAL DELECTRICAL EQUIPMENT needs special precautions
regarding EMC and needs to be installed and put into service according
to the EMC information provided in the ACCOMPANYING
Non-contact forehaed infrared thermometer
:1998)
environment.
EN - 17
:
General
60601-1-2:2001)
DOCUMENTS.