Intended Use - A.MENARINI GLUCOFIX TECH User Manual

1. INTENDED USE

UK
Your GLUCOFIX TECH meter and GLUCOFIX TECH Sensor are in vitro diagnostic medical devices
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to quantitatively measure the glucose level in fresh capillary whole blood.
They are intended for self testing to monitor and control blood glucose levels by people with
diabetes mellitus; they can also be used in a clinical setting by healthcare professionals.
They are not intended for diagnosis or screening of diabetes or for neonatal use.
Do not alter your treatment on the basis of test results of this meter without previously consulting
your doctor or healthcare professional.
The meter complies with the requirements of Directive 98/79/EC on in vitro diagnostic medical
devices and with the requirements of Directive 2011/65/EU on the restriction of use of certain
hazardous substances in electrical and electronic equipment.
The meter is in compliance with Directive 2014/53/EU on radio equipment.
The full text of the EU Declaration of Conformity is available at the following internet address:
www.red.menarinidiagnostics.com.
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GLUCOFIX TECH - 51415 - 02/20
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