AMATECH I-ABSLFH, Instructions For Use Manual, Page: 8 / 334

INSTRUCTIONS FOR USE
Document Number: 80028239
Page 8
Issue Date: 18 MAR 2020
Version: B Ref Blank Template: 80025118 Ver. E
Operating the system:
1.5.1 Applicable Symbols:
Symbol used Description Reference
Indicates the device is a medical
device
MDR 2017/745
Indicates the medical device
manufacturer
EN ISO 15223-1
Indicates the manufacturer’s serial
number. The device serial number
is encoded as 1YYWWSSSSSSS.
 YY indicates the year of
manufacture. i.e. 118WWSSSSSSS
where 18 represents the year
2018.
 WW indicates the number
of the manufacturing week
per a standard shop calendar.
(Leading zeros included.)
 SSSSSSS is a sequential unique
number.
EN ISO 15223-1
Indicates the medical device Global
Trade Item Number 21 CFR 830
MDR 2017/745
Indicates the date when the medical
device was manufactured
EN ISO 15223-1
Indicates the manufacturer’s lot code
using the Julian Date yyddd, where yy
indicates the last two digits of the year
and ddd indicates the day of the year.
i.e. April 4
th
, 2019 would be represented
as 19094.
EN ISO 15223-1
Indicates the manufacturer’s
catalogue number
EN ISO 15223-1
Indicates the need for the user to
consult the instructions for use for
important cautionary information
such as warnings and precautions
EN ISO 15223-1