biolog id SMART STORAGE AGITATOR 30 User manual

USER MANUAL
SMART STORAGE AGITATOR 30
SST-A30
Headquarters:
1, rue du Commandant Robert Malrait
ZA des Granges BP 30303
27303 Bernay cedex France
Phone: [phone]
Fax: [phone]
Web: www.biolog-id.com

User Manual Smart Storage Agitator 30
Version : 1.0
Validation date of the manual: 01/08/2021
2 of 29
Summary
1 General information to the user ..................................................................................................... 4
1.1 Function of the Manual........................................................................................................... 4
1.2 Manual Recipient..................................................................................................................... 4
1.3 Manual Plan............................................................................................................................. 4
1.4 User Tips.................................................................................................................................. 4
1.5 Additional Documents to this Manual .................................................................................... 5
2 Presentation of the Smart Storage Agitator 30............................................................................... 5
2.1 Claimed Use of SST-A30 .......................................................................................................... 5
2.2 Environmental characteristics................................................................................................. 6
2.3 Description of SST-A30............................................................................................................ 8
2.3.1 Calculator and Power ...................................................................................................... 8
2.3.2 Drawer............................................................................................................................. 9
2.3.3 Satellite............................................................................................................................ 9
2.3.4 Temperature sensor...................................................................................................... 10
2.3.5 Agitator sensor .............................................................................................................. 10
2.4 Hardware and software compatibility................................................................................... 10
2.4.1 Agitator.......................................................................................................................... 10
2.4.2 Climate chamber ........................................................................................................... 10
2.4.3 RFID tag ......................................................................................................................... 11
2.4.4 Third party software...................................................................................................... 12
3 Using Smart Storage Agitator (SST-A30) ....................................................................................... 13
3.1 Implementation of PC bags into SST-A30.............................................................................. 13
3.2 Using the Calculator .............................................................................................................. 14
3.3 Status of the satellite LED...................................................................................................... 15
4 Safety instructions......................................................................................................................... 17
4.1 General safety ....................................................................................................................... 17
4.2 Hazards of RF radiation ......................................................................................................... 19
4.3 Electromagnetic compatibility .............................................................................................. 19
4.4 Contraindications .................................................................................................................. 23
4.5 Warning for United States users ........................................................................................... 23
4.6 Warning to users in the CANADA/Attention pour les utilisateurs au CANADA .................... 24

User Manual Smart Storage Agitator 30
Version : 1.0
Validation date of the manual: 01/08/2021
3 of 29
5 Cleaning Instructions..................................................................................................................... 25
6 First Level Maintenance ................................................................................................................ 26
7 Warranty........................................................................................................................................ 27
8 Transport....................................................................................................................................... 27
9 Manufacturer Responsibility......................................................................................................... 27
10 Lifetime.......................................................................................................................................... 28
11 Disposal and recycling ................................................................................................................... 28
12 Product identification.................................................................................................................... 29
13 Logo description............................................................................................................................ 29

User Manual Smart Storage Agitator 30
Version : 1.0
Validation date of the manual: 01/08/2021
4 of 29
1General information to the user
1.1 Function of the Manual
The user manual must be read thoroughly and carefully before using.
This user manual informs you in a clear and detailed manner on how to use the SST-A30 and
to carry out maintenance correctly and safely.
The illustrations and photos in this manual are representative of the SST-A30.
This also applies to all actions, remarks and explanations contained in this manual.
All paper and electronic documentation relating to your SST-A30 must be retained for the life
of your equipment.
1.2 Manual Recipient
This manual is for all users’ groups in SST-A30 throughout its cycle of usage. All topics and
important areas for different groups are treated.
1.3 Manual Plan
The structure of the chapters chronologically follows the various SST-A30 usage phases.
A chapter is dedicated to general safety. Please read this chapter.
1.4 User Tips
If this manual does not give you an answer in case of issues during the operation of the SST-
A30 or if you have any questions concerning the use of the SST-A30, do not hesitate to contact
us at the following email address [email protected].
In the event of a major incident related to SST-A30, you must report it to the manufacturer
and to the competent authority of the Member State in which you are established.

User Manual Smart Storage Agitator 30
Version : 1.0
Validation date of the manual: 01/08/2021
5 of 29
1.5 Additional Documents to this Manual
In parallel with this user manual the below is provided:
•Installation and maintenance instructions. Note that the installation of the SST-A30
must be performed by a trained and authorized person by Biolog-id.
•A manual for using the GUI (Graphical User Interface).
All these manuals are available only in paper format.
2Presentation of the Smart Storage Agitator 30
2.1 Claimed Use of SST-A30
The SST-A30 is a class I medical device used as an accessory to the Helmer PF48 Platelet
Agitator.
The SST-A30 is a Radio Frequency Identification (RFID) product applied to the traceability of
Platelet Concentrate (PC) bags. It secures the storage of bags: the history of each bag is
recorded and accessible to the user. This system makes it possible to trace all the movements
(entry and exit of bags from a platelet agitator).
The SST-A30 constantly communicates with the RFID tags stuck on the PC bags so that it can
display a stock status.
The SST-A30 can also exchange and write data by communicating with a third-party software.
The latter can then display the data related to a bag (expiry date, movements).
Fig. 1: Example of an SST-30 set.