Hillrom O-FAS, Instructions For Use Manual, Page: 8 / 203

INSTRUCTIONS FOR USE
Document Number: 80028140
Page 8
Issue Date: 27 MAR 2020
Version: B Ref Blank Template: 80025117 Ver. F
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 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 date when the medical
device was manufactured
EN ISO 15223-1
Indicates the manufacturer’s
catalogue number
EN ISO 15223-1