SYMBOLS
This instructions for use contains different typefaces and symbols to make the content easier to read
and understand:
•
Standard text—used for regular data.
Boldface text—emphasizes a word or phrase.
•
NOTE:—sets apart special data or important instruction clarification.
•
•
CONTRAINDICATION, WARNING, or CAUTION
–
A CONTRAINDICATION identifies situations or actions that may have an effect on patient
safety.
–
A WARNING identifies situations or actions that may have an effect on patient or user
safety. To ignore a warning could cause patient or user injury.
–
A CAUTION identifies special procedures or precautions that persons must obey to help
prevent equipment damage.
Symbol
Page 9 of 106
ICU Prone Head Positioner Instructions for Use (773439 REV 2 DIR: 80028583 REV A)
P
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
•
manufacturing weeks 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 catalog number
Indicated the need for the user to consult the
instructions for use for important cautionary
information such as warnings and precautions.
Symbols
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
EN ISO 15223-1