Operating The System; Applicable Symbols - AMATECH F-PRSLH Instrucciones De Uso

INSTRUCTIONS FOR USE

Operating the system:

1.5.1

Applicable Symbols:

Symbol used
Document Number: 80028309
Version: B
Description
Indicates the device is a medical device
Indicates the medical device manufacturer
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.
Indicates the medical device Global Trade
Item Number
Indicates the date when the medical
device was manufactured
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
2019 would be represented as 19094.
Indicates the manufacturer's catalogue
number
Indicates the need for the user to consult
the instructions for use for important
cautionary information such as warnings
and precautions
Page 8
Reference
MDR 2017/745
EN ISO 15223-1
EN ISO 15223-1
21 CFR 830
MDR 2017/745
EN ISO 15223-1
EN ISO 15223-1
,
th
EN ISO 15223-1
EN ISO 15223-1
Issue Date: 31 MAR 2020
Ref Blank Template: 80025118 Ver. E