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
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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

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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

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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.

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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.

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2.2 Environmental characteristics
The SST-A30 is designed for usage in hospitals.
The SST-A30 is used in a platelet agitator Helmer PF48 This model has been specifically
qualified to function with the SST-A30.
Fig. 2: SST-A30 for PF48 drawers set.
The incubator / climatic chamber of the blood bank compatible with the SST-A30 manages the
climatic aspects (temperature and hygrometry) of conservation of labile blood products. SST-
A30 does not alter the performance of the platelet agitator nor the performance of the
incubator in which the agitator is placed.
The environmental characteristics of use of SST-A30 are specified in the table below. These
must be respected in order to preserve the proper functioning of the SST-A30.
Operating temperature
0 to 40°C
(FYI: Globtek Power Supply: 0C to + 50°C)
Storage temperature
SST-A30 set: -10°C to 40°C
Special recommendations should be taken for the storage
of the two following components:
Battery:
1 year: -20°C to 25°C

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3 months: -20°C to 45°C
1 month: -20°C to 60°C
Button cell: CR2032
Recommended: + 10°C to + 25°C (not to exceed 30°C)
Operating Humidity
40% RH to 95% RH
Maximum storage humidity
40% RH to 95% RH
(FYI: CR2032 button Recommended: 40% RH to 95% RH)
Atmospheric pressure
Min / max
700hPa
1060hPa

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2.3 Description of SST-A30
This chapter details the different components of the SST-A30 as well as their function.
Fig. 3: SST-A30 set.
2.3.1 Calculator and Power
Fig. 4: Calculator and its power supply set.
The calculator in the SST-A30 system is responsible for managing data, queries and
transferring information to higher-level applications (third-party software for example).
Power supply inlet voltage ranges from 100 to 240 VAC.

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2.3.2 Drawer
The drawer is the component for storing the PC bags.
Fig. 5: Drawer.
2.3.3 Satellite
A RFID satellite placed between two drawers allows the localization of PC bags.
The satellite is a subset consisting of RFID antennas for communication with the RFID tag of
the PC bag.
Fig. 6: Satellite.

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The operating principle of the RFID system is based on a transponder (RFID tag) and an
interrogator (coupler). The latter is an active radiofrequency transmitter device that will
activate the RFID tags located in the slot by providing them with the energy they need to
operate. In addition to the energy, the interrogator sends specific commands to which the
RFID tag responds. For example, the interrogator can ask the tag to return the matching
donation number associated to a unique identifier.
2.3.4 Temperature sensor
The temperature sensor integrated in the SST-A30 is waterproof. It allows to measure the
temperature of an area.
Fig. 7: Temperature sensor.
Only the temperature of the climatic chamber (incubator) is the reference. SST-A30 has no
claimed performance regarding temperature.
The SST-A30 gives the temperature only as an indication. This function does not provide the
safety associated with maintaining the storage temperature of platelet concentrates.
2.3.5 Agitator sensor
The Agitation sensor (accelerometer) integrated in the SST-A30 set allows to record the
shaking and stopping phases of the agitator.
2.4 Hardware and software compatibility
2.4.1 Agitator
The SST-A30 is compatible with the Helmer PF48 agitator.
For more information, please contact Biolog-id's Quality Department at Qualite@biolog-
id.com.
2.4.2 Climate chamber
The SST-A30 is compatible with all environmental chambers used for the storage of the PC
bags if the platelet agitator is not an incubator.

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2.4.3 RFID tag
The RFID tag is used to store product and patient data as well as PC bag traceability data.
Recommendation: For optimal localization, the tag should be centered on the bag.
Fig. 8: Platelet concentrate bag and RFID tag.
Fig. 9: Tag positioning.
You must place your RFID tag on the center of your bag so that the RFID tag cannot be within
2cm of the edges of the drawers of the SST-A30 (risk of non-detection of the RFID chip by the
antenna of the drawer).
The RFID tags compatible with the SST-A30 are passive tags. For more information, please
contact Biolog-id's Quality Department at [email protected].
Tag
positioning
PC bag

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Fig. 10: Area of non-detection of the tag in red.
2.4.4 Third party software
The SST-A30 can subscribe a third-party software and communicate via its web service to
share / exchange PC traceability data (standard communication protocol). The third-party
software can then request the SST-A30 to write data to the RFID tag memory.
In case of use of such software, compatibility validation will be performed with Biolog-id.
The third-party system is responsible for interpreting the data received from the SST-A30.

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3Using Smart Storage Agitator (SST-A30)
This chapter aims to present the SST-A30 operation.
3.1 Implementation of PC bags into SST-A30
1. Open a drawer
2. Place the PC bag on the drawer
Note: In diagnostic mode (verification of the operation of RFID and LEDs) the front of the
satellite flashes.
PC bags can be placed in any direction: in the width or length of the drawer. The maximum
number of PC bags allowed per drawer is 1 for large sizes and 2 for standard sizes.
The RFID tag must be placed on the center of the bag containing the PC face up to a maximum
height of 1.9 cm above the bottom of the drawer.

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3.2 Using the Calculator
The calculator is outside of the incubator. On its facade, it has three types of LEDs, whose
meanings are explained in this chapter.
Calculator LED Light Status
Hardware State
ORANGE LED ON steady
The battery is fully charged.
ORANGE LED ON blinking
The battery is charging.
ORANGE LED OFF
The battery is not charging and
potentially discharged.
Refer to chapter First Level
Maintenance of this manual.
GREEN LED ON steady & RED
LED OFF
Normal and functional
operation mode.
GREEN LED ON blinking & RED
LED OFF
Maintenance and functional
operation mode (cleaning or
technical intervention).
GREEN LED OFF & RED LED ON
steady
Hardware failure or network
disconnection.
Refer to chapter First Level
Maintenance of this manual.
GREEN & RED LED ON steady
Software crashed.
Refer to chapter First Level
Maintenance of this manual.
A battery built into the calculator box keeps the monitoring functions of the RFID electronics
running in case of power interruption for less than 2 hours.

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3.3 Status of the satellite LED
The satellites are placed between 2 drawers. On their front, they have a LED having 3 different
colors whose meanings are explained in this chapter.
Satellites LED Light Status
Hardware State
GREEN LED ON steady
Normal and functional
operation mode.
GREEN LED ON blinking
Maintenance and functional
operation mode (cleaning or
technical intervention).
ORANGE LED ON steady
An error occurs while
reading/writing an RFID chip
with no hardware failure
identified.
Refer to chapter First Level
Maintenance of this manual.
More details above this table.
ORANGE LED ON blinking
A drawer is left open more than
4 minutes.
Close the drawer.
RED LED ON steady
Note: There is potentially no
traceability at the location
where the indicator is red.
Hardware failure.
Refer to chapter First Level
Maintenance of this manual.
GREEN/ORANGE/RED cycle
Note: It is an indicator at
start-up to check that when
powering up the satellites
are working.
5 seconds on power up.
Wait for the complete start of
the hardware.
LED OFF
Hardware OFF or failure.
Refer to chapter First Level
Maintenance of this manual.
In the event of a writing failure on an RFID chip, an error message is returned to the third-
party system that initiated the request and the LED of one or two satellites lights up in orange.
If the RFID chip that could not be written is in:
➢drawer # 1
-The LED of satellite # 1 is lit in orange

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➢drawer # 2
-The LED of satellite # 1 is lit in orange
-The LED of satellite # 2 is lit in orange
➢drawer # 3
-The LED of satellite # 2 is lit in orange
-The LED of satellite # 3 is lit in orange
➢drawer # 4
-The LED of satellite # 3 is lit in orange
-The LED of satellite # 4 is lit in orange
➢drawer # 5
-The LED of satellite # 4 is lit in orange
The orange LED should be off if the write operation is working again or if the RFID tag is no
longer present.

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4Safety instructions
This chapter details the safety precautions to be applied when using the SST-A30.
Please read these instructions carefully.
4.1 General safety
•Have all installation work and adjustments performed by qualified personnel only.
Operations performed by persons lacking competence in this area may adversely
affect the performance of the device and cause damage to property and body.
•Only qualified service technicians will be authorized to perform maintenance
operations and repairs.
•Make sure that the power cord is not pinched or kinked when installing or moving
the machine.
•Do not disassemble or modify system elements once the installation has been
validated.
•Do not put an object other than insert bags on a drawer.
•Do not lean on a drawer.
•The SST-A30 cannot be stored or used outside the temperature and air pressure
ranges specified in this manual (chapter 2.2)
•Do not cover the drawers of the SST-A30 and / or obstruct the air vents.
•The SST-A30 must be fixed in the Platelet agitator so that it cannot be
disassembled without the use of a tool (as part of a maintenance operation).
•Never allow water or other liquids to enter the equipment to avoid the risk of
short circuiting or oxidation of metal parts.
•The use of the SST-A30 is limited to trained and qualified personnel to work in a
medical environment.
•Excluding maintenance activities (see installation and maintenance manual), do
not disconnect the power supply (100 / 240Vac - 15Vdc), do not disconnect the
cable between the calculator and the RFID module attached to the back of the
unit, do not disconnect the Ethernet network cable.
•Do not disconnect satellite from the RFID card if the SST-A30 system is powered.
•The SST-A30 must only be used with the original accessories or original spare parts
as these are the only accessories / spare parts whose reliability, safety and
compatibility with our medical device have been checked.
•In all circumstances, follow the instructions of the safety signs affixed to the SST-
A30.
•The safety instructions on or adjacent to the SST-A30 must always be legible and
complete throughout the life of the product. If, during the life of the SST-A30, the
safety signs are discolored or damaged, notify the Biolog-id support service
([e-mail]).

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•The agitator with the SST-A30 set must be placed on a bench or in an incubator.
•It is forbidden to push the SST-A30.
•It is forbidden to sit on a drawer.
•It is forbidden to go up and walk on a drawer.
RISK
SAFETY RULES
Contamination
Follow the cleaning instructions.
Handling
Operators must follow a training of a person authorized by Biolog-id to know
the operation of the product and its documentation, and especially the safety
instructions.
Electric
The connection cables of the power supply must be installed in accordance
with the national regulations in force.
Electric
The machine-specific electrical voltages must be considered and compared to
the voltages at the installation site on the nameplate before connecting the
installation.
Electric
Follow the wiring diagrams of the machine.
Electric
Connect inevitably the device to a socket protected by a protective conductor.
Electric
To prevent the device from failing due to problems with other electrical
appliances, it must be connected to a separate electrical circuit.
You should not connect it with other electrical devices to a multiple socket
under any circumstances.
Electric
Before connecting and commissioning the machine, check that the power
supply is correctly connected.
Make sure that the connection plug of the device is easily accessible so that it
can easily be removed, if necessary, without having to push other devices.
The socket plug serves as a disconnecting device for the network
Mechanical
Check the fasteners regularly.
Ensure that only operators trained and familiar with security measures use
SST-A30.
Draw the drawers only by the handle provided for this purpose.

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4.2 Hazards of RF radiation
The SST-A30 electronic system antennas each emit a frequency of 13.56 MHz with
a maximum power output of 4,05dBμA/m at 3m (less than the 42dBμA/m limit
threshold).
ELECTROMEDICAL EQUIPMENT requires special precautions regarding EMC. The
SST-A30 must be installed and put into service according to the EMC information
provided by the ACCOMPANYING DOCUMENTS.
Portable or mobile RF communications devices may affect ELECTROMEDICAL
EQUIPMENT
The use of ACCESSORIES, transducers, and cables other than those specified, except
for transducers and cables sold by the EQUIPMENT MANUFACTURER or EM SYSTEM
as replacement parts for internal components, may result in an increase in
EMISSIONS or a decrease in the IMMUNITY of the DEVICE or EM SYSTEM.
The DEVICE or EM SYSTEM should not be used alongside other devices or stacked
with them.
The DEVICE or the EM SYSTEMS may be interfered with by other devices, even if
they comply with the CISPR EMISSION REQUIREMENTS.
4.3 Electromagnetic compatibility
The SST-A30 complies with applicable electromagnetic compatibility standards, however, the
user will ensure that any electromagnetic interference does not create an additional hazard,
such as radiofrequency transmitters or other electronic devices.
In this chapter you will find necessary information to ensure an installation and a
commissioning of the SST-A30 in best conditions in terms of electromagnetic compatibility.
The different cords of the SST-A30 must be distant from each other.
Some types of mobile telecommunication devices such as mobile phones are likely to interfere
with the SST-A30. The separation distances recommended in this chapter must therefore be
strictly observed.
The SST-A30 must not be used near or on another device. If this cannot be avoided, it must be
checked for proper operation under the conditions of use before use. Use of accessories other
than those specified or sold by Biolog-id as replacement parts may result in increased emission
or decreased immunity of the SST-A30.
The SST-A30 uses the 13.56 MHz frequency. The frequency band is 13.553 - 13.567 MHz in
accordance with the ISO 15693 standard. The modulation type is ASK and the RF mode is
TX/RX.
The maximum power output of the PRD_7150200A is 5.04dBμA/m at 3m. The tables below
are for the SST-A30 (PRD_7150200A).

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All information featured below comes from normative requirements which apply to the
manufacturers of medical electrical devices, under standard IEC60601-1-2 Ed4.
Length of cables:
Cables and
accessories
Maximum
length
Type of test
In accordance
with:
Power cable
CAN cable
Ethernet cable
< 3m
< 3m
> 3m
RF emission
CISPR 11, Class B
Harmonic current emissions
IEC 61000-3-2
Voltage fluctuation and flicker
IEC 61000-3-3
Electrostatic discharge immunity
IEC 61000-4-2
Radiated immunity –Electromagnetic fields
IEC 61000-4-3
Immunity to fast transient bursts
IEC 61000-4-4
Surge immunity
IEC 61000-4-5
Conducted immunity –Conducted radio
frequency interference
IEC 61000-4-6
Radiated immunity - Magnetic fields
IEC 61000-4-8
Voltage dips, short interruptions, and
voltage variations immunity
IEC 61000-4-11
Recommended separation distances
The SST-A30 is intended to be used in an electromagnetic environment in which radiated RF
disturbances are controlled.
The user or installer of the medical device can help prevent any electromagnetic interference
by maintaining a minimum distance, as a function of the maximum power output of the radio
frequency transmission equipment. Portable RF communication devices (including peripherals
such as antenna cables and external antennas) should not be used within 30 cm (12 inches) of
any part of the SST-A30, including cables specified by the manufacturer. Otherwise, the
performance of these devices could be adversely affected.
Electromagnetic emissions
The SST-A30 is intended to be used in the electromagnetic environment described in the table
below. The user and installer must therefore ensure that the SST-A30 is used in the
environment described below.
Emission test
Compliance
Electromagnetic environment - comments
Radiated electromagnetic
disturbance
(Radiated emissions)
(CISPR 11)
Group 1
The PRD_7150200A medical devices uses RF
energy for internal operation.
Power terminal disturbance
voltage
(Conducted emissions)
(CISPR 11)
Class B
NA
Harmonic current emissions
Compliant