INSTRUCTIONS FOR USE
1.4.3
Notice to users and/or patients:
Any serious incident that has occurred in relation to the device should be reported
using the contact details provided in section 1.3 of this Instruction for Use and to the
competent authority of the Member State in which the user and/or patient is
established.
Note: Refer to the surgical table manufacturer's user guide for instructions on use.
Always refer to the surgical table manufacturer's weight limits.
NEVER EXCEED THE WEIGHT CAPACITY OF THE OPERATING ROOM TABLE
1.4.4
Safe disposal:
Customers should adhere to all federal, state, regional, and/or local laws and
regulations as it pertains to the safe disposal of medical devices and accessories.
If in doubt, the users of the device shall first contact their supplier for guidance on
safe disposal protocols.
Operating the system:
1.5.1 Applicable Symbols:
Symbol used
Document Number: 80028209
Version: A
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.
Page 7
Reference
MDR 2017/745
EN ISO 15223-1
EN ISO 15223-1
Issue Date: 23 MAR 2020
Ref Blank Template: 80025118 Ver. E