biolog id SST-R Manual de usuario
Smart Storage for fridge : user manual Backup date 12/05/2017 17:14:00
Version 0.10
Author Loïc Marouteau
Manual validation date: 19/04/2017 1 sur 29
USER MANUAL
SMART STORAGE FOR FRIDGE
SST-R
Headquarters:
1, rue du Commandant Robert Malrait
ZA des Granges BP 30303
27303 Bernay cedex France
Tel.: +33 (0)2 32 47 83 40
Fax: +33 (0)2 32 47 83 50
Website: www.biolog-id.com
Smart Storage for fridge : user manual Backup date 12/05/2017 17:14:00
Version 0.10
Author Loïc Marouteau
Manual validation date: 19/04/2017 2 sur 29
Table of Contents
1 General user information. ...........................................................................................................4
1.1 Purpose...............................................................................................................................4
1.2 Intended audience...............................................................................................................4
1.3 Structure. ............................................................................................................................4
1.4 Advice. ................................................................................................................................4
1.5 Accompanying documents...................................................................................................5
2 Overview of the Smart Storage Fridge (SST-R). ............................................................................5
2.1 SST-R intended use. .............................................................................................................5
2.2 Required environmental characteristics for SST-R operation................................................6
2.3 Description of the SST-R. .....................................................................................................8
2.3.1 Processor and power supply. .......................................................................................9
2.3.2 Wiring harness.............................................................................................................9
2.3.3 Drawer.......................................................................................................................10
2.3.4 Satellite......................................................................................................................10
2.3.5 Temperature probe....................................................................................................11
2.4 Hardware and software compatibility................................................................................12
2.4.1 Refrigerator. ..............................................................................................................12
2.4.2 Cold room..................................................................................................................12
2.4.3 RFID label...................................................................................................................13
2.4.4 Third party software. .................................................................................................14
3 Using the Smart Storage Fridge (SST-R). ....................................................................................15
3.1 How to place the RBC bags in the SST-R:............................................................................15
3.2 Using the processor:..........................................................................................................16
4 Safety instructions.....................................................................................................................17
4.1 General safety instructions. ...............................................................................................17
4.2 RF radiation hazards. .........................................................................................................19
4.3 Contraindications ..............................................................................................................23
4.4 Warning for users in United States ....................................................................................23
5 Cleaning instructions.................................................................................................................24
6 First level maintenance. ............................................................................................................26
7 Warranty...................................................................................................................................27
8 Transport ..................................................................................................................................28
Smart Storage for fridge : user manual Backup date 12/05/2017 17:14:00
Version 0.10
Author Loïc Marouteau
Manual validation date: 19/04/2017 3 sur 29
9 Manufacturer liability................................................................................................................28
10 Service life.................................................................................................................................28
11 Disposal and recycling...............................................................................................................28
12 Product identification................................................................................................................29
Smart Storage for fridge : user manual Backup date 12/05/2017 17:14:00
Version 0.10
Author Loïc Marouteau
Manual validation date: 19/04/2017 4 sur 29
1General user information.
1.1 Purpose.
Please read this user manual meticulously and in its entirety before using the equipment.
This manual clearly and extensively sets out how to use the SST-R and service it correctly and
safely.
The illustrations and images contained in this manual represent all the SST-R models.
This also applies to all the actions, comments and explanations contained in this manual.
Please keep all the SST-R documentation for the service life of your equipment.
1.2 Intended audience.
This manual is intended for all users likely to carry out operations on the SST-R during its
usage cycle. It covers all the main fields and topics for the various user groups.
1.3 Structure.
The chapters are arranged chronologically in SST-R usage phase order, making it quick and
easy to find answers to specific questions by selectively reading the contents of the relevant
topics.
One of the chapters is devoted to the general safety instructions. Please read it meticulously.
1.4 Advice.
If you cannot find answers to questions arising from SST-R operation or general questions
concerning the work done by the SST-R in this manual, please do not hesitate to contact us
Smart Storage for fridge : user manual Backup date 12/05/2017 17:14:00
Version 0.10
Author Loïc Marouteau
Manual validation date: 19/04/2017 5 sur 29
1.5 Accompanying documents
The following are provided in addition to this user manual:
-General installation and maintenance instructions
-A manual on using the HMI (Human Machine Interface)
-Information on spare parts
-Certificates
All manuals are available in hard copy only.
The SST-R must be installed by Biolog-id trained and authorised personnel.
2Overview of the Smart Storage Fridge (SST-R).
2.1 SST-R intended use.
The SST-R is a class I medical device used as a blood bank refrigerator/cold room accessory.
It is a fixed device that can only be used inside buildings.
The SST-R is a Radio-Frequency Identification (RFID) product used to track packed red blood
cell (RBC) bags. It improves blood bag storage safety by recording the history of each bag
and making it available to the user. This system tracks all bag movements into and out of the
refrigerator or cold room.
The SST-R is in permanent communication with the RFID tags affixed to the RBC bags so that
it can display the stock status.
Fig.Example of an SST-R Kit
PROCESSOR
DRAWERS
Smart Storage for fridge : user manual Backup date 12/05/2017 17:14:00
Version 0.10
Author Loïc Marouteau
Manual validation date: 19/04/2017 6 sur 29
The SST-R can also exchange and write data by communicating with a third party program
linked to the SST-R that displays bag data (expiry date, movements, etc.).
2.2 Required environmental characteristics for SST-R operation.
The SST-R is designed to be used in a hospital environment by laboratory technicians who
have been specially trained to handle RBC bags.
The SST-R is used inside a blood bank refrigerator/cold room that has been specifically
qualified to work with this medical device. (cf Chapter 2.4, Hardware and software
compatibility).
Fig.Installing the drawer modules in a refrigerator
Fig. SST-R drawer assembly
The SST-R-compatible blood bank refrigerator/cold room controls the climate-related
aspects (temperature and hygrometry) of labile blood product storage. The SST-R does not
impact the performance of the refrigerator/cold room.
The required environmental characteristics for SST-R operation are specified in the table
below. It is important that these are followed in order for the SST-R to operate correctly
Smart Storage for fridge : user manual Backup date 12/05/2017 17:14:00
Version 0.10
Author Loïc Marouteau
Manual validation date: 19/04/2017 7 sur 29
Operating temperature
0 to 40°C
(Power supply: -25°C to +40°C)
Storage temperature
SST
-
R Kit:
-
10°C to 40°C
Special recommendations must be followed when
storing the following two components:
Battery:
1 year: -20°C to 25°C
3 months: -20°C to 45°C
1 month: -20°C to 60°C
Button cell: CR2032
Recommendation: +10°C to +25°C
(do not exceed 30°C)
Operating humidity
40% RH to 95% RH
Maximum storage humidity
40% RH to 95% RH
(CR2032 button cell Recommendation: 40% RH to 95%
RH)
Atmospheric pressure
Min / Max
700hPa
1060hPa
Smart Storage for fridge : user manual Backup date 12/05/2017 17:14:00
Version 0.10
Author Loïc Marouteau
Manual validation date: 19/04/2017 8 sur 29
2.3 Description of the SST-R.
This chapter details the component parts of the SST-R kit and their functions.
Fig. SST-R kit
Smart Storage for fridge : user manual Backup date 12/05/2017 17:14:00
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Author Loïc Marouteau
Manual validation date: 19/04/2017 9 sur 29
2.3.1 Processor and power supply.
Fig.Processor and power supply
The middleware referred to as the processor in the SST-R system manages the data, queries
and transfers to higher level applications such as third party programs.
2.3.2 Wiring harness.
Fig. wiring harness
The wiring harness supplies power to the individual drawers and carries the data between
the processor and the RFID antennas.
Smart Storage for fridge : user manual Backup date 12/05/2017 17:14:00
Version 0.10
Author Loïc Marouteau
Manual validation date: 19/04/2017 10 sur 29
2.3.3 Drawer.
Fig. drawer unit
The drawer is the module used to store the RBC bags.
There are 3 ranges of drawers with different storage arrangements:
-8 spaces (2 rows of 4 spaces).
-12 spaces (3 rows of 4 spaces).
-15 spaces (3 rows of 5 spaces).
2.3.4 Satellite.
Fig. satellite box
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