VisioFocus PRO 06480 - Regulatory Compliance (UE)

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+40°C (60.8 and 104°F). Store at a temperature not lower than -25°C (-13°F) or higher
than +70°C (158°F).
- Internally powered equipment; mode of operation: continuous.
- The VisioFocus PRO LEDs emit low light radiation in compliance with EN 62471.
- Measuring system tested in hospitals, private clinics and medical oces. Clinical
accuracy, characteristics and procedures are available from the manufacturer on re
-
quest.
13.3 Declaration of Conformity UE
Tecnimed srl, P.le Cocchi, 12 - 21040 Vedano Olona (VA) - Italy is the manufacturer of
the VisioFocus PRO 06480 non-contact clinical infrared thermometer.
TECNIMED guarantees that VisioFocus PRO 06480 meets all the provisions appli
-
cable in the Regulation (UE) 2017/745.
VisioFocus PRO 06480 is a class IIa medical device manufactured following appro
-
priate production processes in accordance with an EN ISO 9001:2015 and EN ISO
13485:2016 certied Quality System, with GMP requirements and with the following
standards: EN 60601-1, EN 60601-1-2, EN 60601-1-6, EN 60601-1-11, EN 62366,
EN 62471, EN 62304, EN 80601-2-56, ASTM E 1965-98.
Full responsibility for the conformance of this product to the standards is assumed by
Tecnimed srl, P.le Cocchi, 12 - 21040 Vedano Olona (VA) – ITALY.
Complete Declaration of Conformity is available from the manufacturer on request:
info@tecnimed.eu
SYMBOLS on the thermometer, on its packaging or in this user manual:
Manufacturer
UDI
UDI code
MD
Medical Device
SN
Serial Number
0051
European Conformity mark. The product conforms to:
- Regulation (EU) 2017/745 on medical devices. The Conformity to
the Regulation (EU) 2017/745 applies to the medical use only and it is
veried by the notied body no. 0051 (IMQ).
- 2014/30/EU directive for the non-medical use (ref. par. 4.4)
Operating
instructions
Refer to the instruction manual
CAUTION: read the
warnings
Direct current