Mediblink M520 - Reference to Standards; Remark

17
EN
11. Reference to Standards
Device standard: Device corresponds to the requirements of the European
standard for non-invasive blood- pressure monitor.
Standard
IEC60601-1-6:2010+A1:2013 / EN60601-1-6:2010+A1:2015
IEC60601-1:2005+A1:2012 / EN60601 1:2006+A11:2011+A1:2013+A12:2014
IEC60601-1-2:2014 / EN60601-1-2:2015
IEC / EN60601-1-11:2015
IEC80601-2-30:2009+A1:2013 / EN80601-2-30:2010+A1:2015
The stipulations of the EU-Guidelines 93 / 42 / EEC for Medical Products Class
IIa have been fullled.
12. Remark
Serial number
Class IIa medical device
Unique Device Identication
system
Number of products in one
packaging
Before use, read the instructions.
Electronic instructions for use:
http://www.mediblink.com/f/m520.pdf
Type BF equipment
IP22 Ingress of water
EU Representative
Some electrical and electrical
equipment forbid to abandon and
disposal at will
Manufacturer’s name and address
Inapplicable baby
Cu󰀨 Connector
Warning! Consult accompanying
documents
Product reference number
#
Model number
Batch number*
*TheproductiondatecanbereadfromLOTnumber[YYYYMM];rstfourdigitsrepresenttheYearandlast
twodigitsMonthofproduction.Example:LOT202503=March2025