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Certicates and Standards
The product is in accordance with EC
MDD Directive (93/42/EEC). The fol-
lowing standards apply to the product
manufacture or product design:
ASTM E1965-98
Specication for Infrared Thermom-
eters for Intermittent Determination
of Patient Temperature.
● ISO 14971
Medical devices — Application of
risk management to medical devic-
es. Classication in accordance with
IEC/EN 60601-1, clause 5:
▪ Internal power supply device
▪ IPX0
The device is not suitable for use
with a mixture of ammable anes-
thetic and air, oxygen, or laughing
gas.
Serial number
Number of products in one
packaging
Thermometer certied in
accordance with EU Directive
93/42/EEC
The symbol provides useful
additional information on the
assembly or use
Protection against electric
shock in accordance with BF
(Body Float) type. BF type
device with a high degree of
protection against electric shock
to the body, but not directly to
the heart.
Upon the cessation of the life
cycle of the device, dispose of
the device in accordance with
the local law
Manufacturer name and
address
EU Representative
IP 22
The device is rated IP 22,
which means it is protected
against water and dust particles
entering the device
ENG
Warning!
Before use, read the instruc-
tions for use
Electronic instructions for use:
http://www.mediblink.com/f/
m300.pdf
Product reference number
Class IIa medical device
LOT number*
*Date of production: the rst two digits of the LOT number represent the month of production, and the
second two digits represent the year of production. Example: LOT 10/19 = October 2019.
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