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1 | Product Manual | Users Manual | 1.94 MiB | January 15 2021 / July 17 2021 | delayed release |
SMART STORAGE HIGH DENSITY
SST-HD
USER MANUAL
Main Establishment:
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
Web: www.biolog-id.com
Smart Storage High Density User Manual
Version
0.6
Contents
1
General user information. ............................................................................................................... 4
1.1
1.2
1.3
1.4
1.5
2.1
2.2
2.3
Purpose of the manual. ........................................................................................................... 4
Intended audience................................................................................................................... 4
Structure of the manual. ......................................................................................................... 4
User advice. ............................................................................................................................. 4
Documents supplementing this manual ................................................................................. 4
2
Presentation of the Smart Storage High Density (SST-HD). ............................................................ 5
Claimed use of the SST-HD. ..................................................................................................... 5
Required environmental characteristics for SST-HD operation. ............................................. 5
Description of the SST-HD. ...................................................................................................... 8
2.3.1
Processor and power supply ........................................................................................... 9
2.3.2 Wiring harness ................................................................................................................. 9
2.3.3
Tray ................................................................................................................................ 10
2.3.4
Satellite .......................................................................................................................... 10
2.4
Hardware and software compatibility .................................................................................. 11
2.4.1
Freezer and refrigerator. ............................................................................................... 11
2.4.2
Cold room. ..................................................................................................................... 11
2.4.3
RFID tag. ........................................................................................................................ 11
2.4.4
Third-party software. .................................................................................................... 12
3 Using the Smart Storage High Density (SST-HD). .......................................................................... 13
3.1
Placing bags in the SST-HD and satellite indicator lights....................................................... 13
3.1.1
Placing bags in the SST-HD ............................................................................................ 13
3.1.2
Satellite light indicators ................................................................................................. 14
3.2
Processor light indicators ...................................................................................................... 15
4
Safety instructions. ........................................................................................................................ 16
4.1
4.2
4.3
4.4
General safety instructions. .................................................................................................. 16
RF radiation hazards. ............................................................................................................. 18
Electromagnetic compatibility: ............................................................................................. 19
Contraindications .................................................................................................................. 23
4.5 Warning for United States users ........................................................................................... 23
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4.6 Warning to users in the CANADA / Attention pour les utilisateurs au CANADA .................. 24
Cleaning instructions ..................................................................................................................... 25
First-level maintenance. ................................................................................................................ 27
7 Warranty ....................................................................................................................................... 28
8
Transport ....................................................................................................................................... 28
9 Manufacturer liability .................................................................................................................... 28
10 Service life ..................................................................................................................................... 29
11 Disposal and recycling ................................................................................................................... 29
12 Product identification .................................................................................................................... 30
13 Description of the logos ................................................................................................................ 31
5
6
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1 General user information.
1.1 Purpose of the manual.
Please read this user manual carefully and in its entirety before using the equipment.
This manual clearly and extensively gives you information on how to use the SST-HD and how
to maintain it properly and safely.
The illustrations and images contained in this manual represent all the SST-HD models.
This also applies to all the actions, comments and explanations contained in this manual.
Please keep all documentation on the SST-HD for its entire service life.
Throughout this document:
• The term “bag” refers to a bag of packed red blood cells.
• The term “ LBP” refers to the Labile Blood Product
1.2 Intended audience.
This manual is intended for all users likely to carry out operations on the SST-HD throughout
its usage cycle. It covers all the main fields and topics for the various user groups.
1.3 Structure of the manual.
The structure of the chapters follows the chronological order of the various usage phases of
the SST-HD.
Please read the chapter dedicated to general safety instructions carefully.
1.4 User advice.
If you cannot find answers to questions linked to the operation or use of the SST-HD in this
manual, do not hesitate to contact us at the following email address customercare@biolog.com
In the event of a serious incident relating to the SST-HD, this must be reported to the
manufacturer and the competent authority for the member state in which you are
established.
1.5 Documents supplementing this manual
The following is provided along with this user manual:
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•
•
Installation and maintenance manual. Note that the SST-HD must be installed
by a trained individual authorised by Biolog-id.
Manual for using the HMI (Human Machine Interface)
All these manuals are available in paper and PDF format.
2 Presentation of the Smart Storage High Density (SST-HD).
2.1 Claimed use of the SST-HD.
The SST-HD is a class I medical device used as a blood bank refrigerator or cold room
accessory. It is a fixed device which can only be used inside this type of equipment.
The SST-HD is a Radio-Frequency Identification (RFID) product used to track packed red
blood cell (RBC) bags. It improves blood bag storage safety.
The SST-HD is in permanent communication with the RFID tags affixed to the bags. This
ensures that the history of each bag is recorded and accessible to users.
The SST-HD tracks all bag movements into and out of the storage unit and displays a stock
status.
Figure 1 – Processor (above) and 20-tray SST-HD kit (right)
The SST-HD can also exchange and write data by communicating with third-party software.
This software can then display data relating to a bag (expiry date, movements, etc.).
2.2 Required environmental characteristics for SST-HD operation.
The SST-HD is designed to be used in a hospital environment by laboratory technicians who
have been specifically trained to handle blood products.
The SST-HD is used inside a blood bank refrigerator or cold room that has been specifically
qualified to work with this medical device. (See Chapter 2.4, Hardware and software
compatibility).
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Fig. Installing the tray modules in a refrigerator
Figure 2 – SST-HD shelf assembly
SST-HD compatible storage units manage the climate-related aspects (temperature and
moisture) of the storage of the blood products they contain. The SST-HD in no way alters the
performance of the unit in which it is installed.
The required environmental characteristics for SST-HD operation are specified in the table
below. It is important that these are followed in order for the SST-HD to operate correctly.
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Operating temperature
0°C to 40°C
Storage temperature
(GlobTek external supply: 0°C to +50)
SST-HD 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
Recommended: +10°C to +25°C
(Do not exceed 30°C)
Operating humidity
10% RH to 95% RH
10% RH to 95% RH
Maximum storage humidity
(CR2032 button cell Recommendation: 40% RH
to 95% RH)
Atmospheric pressure
Min/max
700hPa
1060hPa
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2.3 Description of the SST-HD.
This chapter describes the component parts of the SST-HD kit and their function.
Figure 3 - SST-HD kit with 5 elementary satellite kits
Trays
Satellite
Figure 4 - SST-HD elementary satellite kit composed of 4 trays and a satellite
The system is designed to have a between 1 and 6 elementary satellites. The device must
not be overloaded.
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2.3.1 Processor and power supply
Figure 5 - SST-HD processor
The processor in the SST-HD system manages data and queries and transfers information to
higher-level applications such as third-party software.
Power supply inlet voltage ranges from 100 to 240 VAC.
2.3.2 Wiring harness
Figure 6 - SST-HD wiring harness
A wiring harness supplies power to every satellite and carries data between the processor and
the RFID antennas.
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2.3.3 Tray
Figure 6 - SST-HD tray
The tray is the module used to store the LBP bags.
The tray must not be overloaded.
There are two ranges of tray:
• Those which can contain up to 14 bags (the HD45);
• Those which can contain up to 18 bags (the HD60).
2.3.4 Satellite
Figure 7 - SST-HD satellite
A “satellite” is fitted below each row of trays enabling the bags to be located. The satellite
consists of a sub-assembly of RFID antennas which communicate with the RFID tag affixed
to the bag.
The operating principle of the RFID system is based on a transponder (RFID tags) and an
interrogator (coupler). The interrogator is an active radio-frequency emitter. These radio
frequencies activate the RFID tags affixed onto the bags by supplying them with the energy
they need to operate. In addition to supplying the energy, the interrogator also sends specific
commands to which the RFID tag responds. A simple command might involve returning the
donation number corresponding with a unique identifier.
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2.4 Hardware and software compatibility
This chapter details the third-party hardware and software compatible with the SST-HD.
2.4.1 Freezer and refrigerator.
The SST-HD is compatible with the refrigerators on the market, provided that they are
referenced by Biolog-id.
Before any installation of an SST-HD in a refrigerator, Biolog-id conducts thermal compatibility tests.
For further details, please contact the Biolog-id quality department at: Qualite@biolog-
id.com
2.4.2 Cold room.
The SST-HD is compatible with all bag storage cold rooms. When used in this way, the SST-
HD is installed using its specific cold room storage unit.
Before installing an SST-HD in a cold room, Biolog-id conducts compatibility tests on the
SST-HD and the cold room beforehand.
2.4.3 RFID tag.
Figure 8 – Blood bag and RFID tag
The RFID tag stores product and patient data as well as bag tracking data. Only passive RFID
tags referenced by Biolog-id are compatible with the SST-HD.
For further details, please contact the quality department at: Qualite@biolog-id.com
For optimal RFID reading, the side of the bags on which the RFID tag is affixed must all be
facing the same way in the tray (all towards the front of the tray)
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Recommendation: For optimal location, the tag should be positioned on the bag as follows:
O
p
t
i
m
a
l
a
r
e
a
50mm
50mm
m
1
2
5
m
6
0
m
m
Figure 9 – Position of the tag on the bag for optimal RFID reading
2.4.4 Third-party software.
The SST-HD can link to third-party software and communicate via their web service to
share/exchange tracking data relating to bags equipped with RFID tags. The third-party
software can then ask the SST-HD to write data to the RFID tag memory.
If third-party software is used, its compatibility must be validated. In this case, please
contact Biolog-id.
The third-party system is responsible for interpreting the data received from the SST-HD.
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3 Using the Smart Storage High Density (SST-HD).
The purpose of this chapter is to describe how the SST-HD works.
3.1 Placing bags in the SST-HD and satellite indicator lights
3.1.1 Placing bags in the SST-HD
1 - Open a tray with available spaces
2 - Place the bag in a vertical position in the tray
N.B. Be particularly careful with the tube when
handing the bag
3 - Close the tray
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3.1.2 Satellite light indicators
LED status
Green
Meaning
Action(s) required
The tray is functional and
empty
No action required
The satellite is in
maintenance mode
Wait for the end of the maintenance currently
in progress before handling the trays in
question and/or their contents
The tray in question is
functional and contains at
least one bag
No action required
Tray in which the desired
bag is located
Open the tray and remove the bag(s) you are
looking for.
If no action is taken within five minutes, the
flashing stops and the normal cycle is
resumed
RFID read/write error
Please refer to Chapter 6 - 1st level
maintenance in this manual
Firmware update in
progress
Wait for the end of the update currently in
progress before handling the trays in question
and/or their contents
Satellite rebooting
following:
• 1st installation
• Update
• Firmware reboot
Wait until the satellite is functional (blue or
green indicator) before handling the trays in
question and/or their content
Power supply fault
Please refer to Chapter 6 - 1st level
maintenance in this manual
Flashing green
Blue
Flashing blue
Orange (Yellow)
Flashing orange
Green-Orange-
Red cycle
Off
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3.2 Processor light indicators
The processor is located outside the refrigerated storage unit. There are three LEDs on the
front of the processor, the meanings of which are explained in this chapter.
LED status
Green
Flashing green
Orange
Flashing orange
Red (green LED off)
One green and one red
Green only
Meaning
Action(s) required
The processor is in normal
operating mode and is
functioning normally.
No action required
The processor is in
maintenance operating mode
and is functioning normally
No action required
The battery is fully charged
No action required
The battery is charging
No action required
The processor is faulty or it is
disconnected from the
network.
Please refer to Chapter 6 - 1st
level maintenance in this
manual
Embedded software has an
anomaly.
Please refer to Chapter 6 - 1st
level maintenance in this
manual
The battery is no longer
charging and may be
discharged. Make sure that
the mains cable is plugged in.
Please refer to Chapter 6 - 1st
level maintenance in this
manual
A battery integrated into the processor box provides backup power to keep the RFID
electronic surveillance functions working for at least 2 hours.
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4 Safety instructions.
This chapter provides a detailed description of the safety instructions applicable when using
the SST-HD.
Please read these instructions carefully
4.1 General safety instructions.
• The SST-HD must only be used with original accessories and spare parts as these are the
only accessories/spare parts whose reliability, safety and compatibility with our medical
device have been controlled
• Always follow the instructions shown on the safety labels affixed to the SST-HD.
• The safety instructions affixed to or beside the SST-HD must remain legible and complete
throughout the period the product is in use. If the safety labels become discoloured or
damaged during the service life of the SST-HD, please inform Biolog-id customer support
(customercare@biolog-id.com).
• The SST-HD must be installed in a blood bank refrigerator, freezer or cold room which is stable and
equipped with an anti-tipping system (this generally requires attachment to the wall).
• Never push the SST-HD.
• Never sit on a tray or satellite.
• Never climb onto or walk on a tray or satellite.
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RISK
Contamination
Follow the cleaning instructions.
SAFETY INSTRUCTIONS
Handling error
• Operators must undergo authorised Biolog-id training so that they know
how the product works, are familiar with the documentation and, more
specifically, are aware of the safety instructions.
• Trays must be handled with no sudden movements.
•
Install power supply connecting cables in accordance with applicable national
regulations.
• Take into account the machine-specific electrical voltages and compare them
to the voltages available at the installation location on the data plates before
the installation is connected.
• Machine wiring diagrams must be complied with.
• The device must be connected to a socket with a Circuit Protective
Conductor*
Electrical
• To prevent the system from breaking down due to problems with other
electrical devices, it must be connected to a separate electrical circuit.
• Under no circumstances should it be connected to a multi-socket along with
• Before connecting and commissioning the machine, check that the power
other electrical devices.
supply is connected correctly.
• Ensure that the device connecting plug is readily accessible so that it can be
pulled out easily when necessary, without having to push other devices out of
the way.
• The power plug serves as a network disconnection device.
Regularly check the fixings.
Make sure that only trained operators who are familiar with the safety measures use
the SST-HD
Mechanical
Only pull out the trays using the handles provided.
After handling and before releasing the tray, always check that it is in a stable
state.
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Mechanical
Never hang from the satellites.
Thermal
The SST-RHD processor can reach temperatures higher than 50°C. Do not
touch the processor while it is in these conditions.
4.2 RF radiation hazards.
The SST-HD electronic system antennas each emit a frequency of 13.56 MHz
with a maximum power output :
6.9 dBµA/m at 3 m for PRD_7170100A.
6.9 dBµA/m at 3 m for PRD_7170200A.
(less than the 42 dBµA/m limit threshold).
MEDICAL ELECTRICAL DEVICES require special EMC precautions. The SST-
HD must be installed and commissioned in accordance with the EMC data
supplied in the ACCOMPANYING DOCUMENTS.
Portable or mobile RF communication devices can affect MEDICAL
ELECTRICAL DEVICES
Using ACCESSORIES, transducers or cables other than those specified can
increase EMISSIONS or reduce the IMMUNITY of the DEVICE or EM
SYSTEM. This does not include transducers and cables sold by the
MANUFACTURER of the DEVICE or EM SYSTEM and used as spare parts to
replace internal components.
The DEVICE or EM SYSTEM must not be used beside other devices or
stacked with them.
The DEVICE or EM SYSTEMS can be affected by interference caused by
other devices even if they comply with CISPR EMISSION requirements.
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4.3 Electromagnetic compatibility:
While the SST-HD complies with current electromagnetic compatibility standards, users
must ensure that any electromagnetic interference does not create additional risk, such as
RF transmitters or other electronic devices.
In this chapter you will find the information you need to ensure the best possible installation
and commissioning of the SST-HD in terms of electromagnetic compatibility.
The different cords of the SST-HD must be placed far apart.
Certain types of mobile telecommunication devices such as mobile phones are likely to
interfere with the SST-HD. The separation distances recommended in this chapter must
therefore be complied with.
The SST-HD should not be used in the vicinity or placed on top of another device. If this
cannot be avoided, its effective operation must be checked under operational conditions
before use. Using accessories other than those specified or sold by Biolog-id as replacement
parts can increase emissions or reduce the immunity of the SST-HD.
The SST-HD 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_7170100A and PRD_7170200A is 6.9dBµA/m at 3m.
The tables below relate to the SST-HD range (PRD_7170100A et PRD_7170200A).
All information featured below comes from normative requirements which apply to the
manufacturers of medical electrical devices, under standard IEC60601-1-2 Ed4.
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Length of cables:
Cables and accessories
Type of test
In accordance with
Maximum
length
Power cable
< 3m
Voltage fluctuation and flicker
RF emission
Harmonic current emissions
CISPR 11, Class B
IEC 61000-3-2
IEC 61000-3-3
Electrostatic discharge immunity
IEC 61000-4-2
CAN cable
< 3m
immunity – Electromagnetic
IEC 61000-4-3
Radiated
fields
Ethernet cable
> 3m
Surge immunity
Immunity to fast transient bursts
IEC 61000-4-4
IEC 61000-4-5
IEC 61000-4-6
Conducted immunity – Conducted radio
frequency interference
Radiated immunity - Magnetic fields
IEC 61000-4-8
Voltage dips, short
voltage variations immunity
interruptions and
IEC 61000-4-11
Recommended separation distances:
The SST-HD 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-HD, including cables specified by the manufacturer.
Otherwise the performance of these devices could be adversely affected.
Electromagnetic emissions
The SST-HD is intended to be used in the electromagnetic environment described in the table
below. The user and installer must therefore ensure that the SST-HD is used in the
environment described below.
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electromagnetic
Compliance
Group 1
Electromagnetic environment - comments
The PRD_7170100A et PRD_7170200A medical
devices uses RF energy for internal operation.
Emission test
Radiated
disturbance
(Radiated emissions)
(CISPR 11)
Power terminal disturbance voltage
Class B
NA
(Conducted emissions)
(CISPR 11)
Harmonic current emissions
(IEC61000-3-2)
Voltage
fluctuations and flicker
variations,
(IEC61000-3-3)
Compliant
voltage
Compliant
Magnetic and electromagnetic immunity
The SST-HD is intended to be used in the magnetic and electromagnetic environment
described in the table below. The user and the installer must guarantee the compliance of the
electromagnetic environment.
Immunity test
Compliance level
level according to
Test
IEC60601
Electrostatic discharge (ESD)
± 8 kV contact discharge
± 8 kV contact discharge
Electromagnetic
environment/comments
Professional
facility environment.
healthcare
± 15 kV air discharge
± 2 kV; ± 4 kV; ± 8 kV; ± 15
kV air discharge
± 2 kV for power supply
lines
± 2 kV for power supply
lines
± 1 kV for signal ports
Professional
facility environment.
healthcare
Surges
± 1 kV in Differential mode
± 1 kV in Differential mode
Professional
facility environment.
healthcare
(IEC61000-4-2)
Fast transient bursts
(IEC61000-4-4)
(IEC61000-4-5)
± 2 kV in common mode
± 2 kV in common mode
Power-frequency magnetic
field
30 A/m
30 A/m
Professional
facility environment.
healthcare
(IEC61000-4-8)
short
Voltage
interruptions and voltage
variations
dips,
(IEC61000-4-11)
0% UT for 0.5 cycles
0% UT for 0.5 cycles
At 0°, 45°, 90°, 135°, 180°,
225°, 270° and 315°
At 0°, 45°, 90°, 135°, 180°,
225°, 270° and 315°
healthcare
Professional
facility environment.
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0% UT for 1 cycle
0% UT for 1 cycle
70% UT
70% UT
for 25 cycles at 50 Hz
for 25 cycles at 50 Hz
For 30 cycles at 60 Hz
For 30 cycles at 60 Hz
Single-phase: at 0°
0% UT;
Single-phase: at 0°
0% UT;
for 250 cycles at 50 Hz
for 250 cycles at 50 Hz
for 300 cycles at 60 Hz
for 300 cycles at 60 Hz
Voltage interruptions
(IEC61000-4-11)
healthcare
Professional
facility environment.
Electromagnetic immunity, radio frequencies:
The SST-HD is intended to be used in the magnetic and electromagnetic environment
described in the table below. The user and the installer must guarantee the compliance of the
electromagnetic environment.
Immunity test
Test level
Compliance level
Electromagnetic
environment/comments
WARNING: 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 PRD_7170100A
and PRD_7170200A, including cables specified by the manufacturer. Otherwise the performance of
these devices could be adversely affected.
RF
Radiated
electromagnetic fields
Professional
facility environment.
healthcare
3 V/m
3 V/m
80 MHz to 2.7 GHz
80 MHz to 2.7 GHz
Professional
facility environment.
healthcare
(IEC61000-4-3)
Proximity fields emitted by
wireless RF communication
devices
61000-4-3
interim method)
(IEC
80% MA at 1 kHz
80% MA at 1 kHz
9 V/m
9 V/m
710 MHz, 745 MHz,
710 MHz, 745 MHz,
780 MHz, 5240 MHz,
780 MHz, 5240 MHz,
5550 MHz, 5785 MHz
5550 MHz, 5785 MHz
27 V/m
385 MHz
27 V/m
385 MHz
28 V/m
28 V/m
450 MHz, 810 MHz,
450 MHz, 810 MHz,
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Conducted
induced by RF
fields (IEC610004-6)
disturbances,
3 V
3 V
Professional
facility environment.
healthcare
150 kHz to 80 MHz
150 kHz to 80 MHz
870 MHz, 930 MHz,
870 MHz, 930 MHz,
1720 MHz, 1845 MHz,
1720 MHz, 1845 MHz,
1970 MHz, 2450 MHz
1970 MHz, 2450 MHz
6 V within ISM band and
6 V within ISM band and
band ranging from
band ranging from
0.15 MHz to 80 MHz,
0.15 MHz to 80 MHz,
80% MA at 1 kHz
80% MA at 1 kHz
4.4 Contraindications
As a preventive measure, it is recommended that people fitted with pacemakers do not
use the SST-HD.
4.5 Warning for United States users
Federal Communication Commission Interference
Statement 47 CFR Section 15.105(b)
This equipment has been tested and found to comply with the limits for a Class B digital device,
pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable
protection against harmful interference in a residential installation. This equipment generates
uses and can radiate radio frequency energy and, if not installed and used in accordance with
the instructions, may cause harmful interference to radio communications. However, there is
no guarantee that interference will not occur in a particular installation. If this equipment does
cause harmful interference to radio or television reception, which can be determined by
turning the equipment off and on, the user is encouraged to try to correct the interference by
one of the following measures:
- Reorient or relocate the receiving antenna.
- Increase the separation between the equipment and receiver.
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- Connect the equipment into an outlet on a circuit different from that to which the
receiver is connected.
- Consult the dealer or an experienced radio/TV technician for help.
This PRD_7170100A and PRD_7170200A complies with Part 15 of the FCC Rules. Operation is
subject to the following two conditions: (1) This device may not cause harmful interference,
and (2) this device must accept any interference received, including interference that may
cause undesired operation.
NO UNAUTHORIZED MODIFICATIONS
47 CFR Section 15.21
CAUTION: This equipment may not be modified, altered, or changed in any way without signed
written permission from Biolog-id. Unauthorized modification may void the equipment
authorization from the FCC and will void the Biolog-id warranty.
This device complies with FCC RF radiation exposure limits set forth for general population
(uncontrolled exposure). This device must be installed to provide a separation distance of at
least 20cm from all persons and must not be collocated or operating in conjunction with any
other antenna or transmitter.
4.6 Warning to users in the CANADA / Attention pour les utilisateurs
au CANADA
This device complies with Industry Canada licence-exempt RSS standard(s). Operation is
subject to the following two conditions: (1) this device may not cause interference, and (2)
this device must accept any interference, including interference that may cause undesired
operation of the device.
Under Industry Canada regulations, this radio transmitter may only operate using an antenna
of a type and maximum (or lesser) gain approved for the transmitter by Industry Canada.
To reduce potential radio interference to other users, the antenna type and its gain should be
so chosen that the equivalent isotropically radiated power (e.i.r.p.) is not more than that
necessary for successful communication.
This device complies with Industry Canada RF radiation exposure limits set forth for general
population (uncontrolled exposure). This device must be installed to provide a separation
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distance of at least 20cm from all persons and must not be collocated or operating in
conjunction with any other antenna or transmitter.
Le présent appareil est conforme aux CNR d’Industrie Canada applicables aux appareils radio
exempts de licence. L’exploitation est autorisée aux deux conditions suivantes: (1) il ne doit
pas produire de brouillage, et (2) l’utilisateur du dispositif doit être prêt a accepter tout
brouillage radioélectrique reçu, même si ce brouillage est susceptible de compromettre le
fonctionnement du dispositif.
Conformément à la réglementation d’Industrie Canada, le présent émetteur radio peut
fonctionner avec une antenne d’un type et d’un gain maximal (ou inférieur) approuvé pour
l’émetteur par Industrie Canada.
Dans le but de réduire les risques de brouillage radioélectrique à l’ intention d’autres
utilisateurs, il faut choisir le type d’antenne et son gain de sorte que la puissance isotrope
rayonnée équivalente (p.i.r.e.) ne dépasse pas l’intensité nécessaire à l’établissement d’une
communication satisfaisante.
Le présent appareil est conforme aux niveaux limites d’exigences d’exposition RF aux
personnes définies par Industrie Canada. Cet appareil doit être installé afin d’offrir une
distance de séparation d’au moins 20cm avec l’utilisateur, et ne doit pas être installé à
proximité ou être utilisé en conjonction avec une autre antenne ou un autre émetteur.
5 Cleaning instructions
This chapter sets out the SST-HD cleaning procedure to follow.
The device must be cleaned or disinfected before use.
The SST-HD must be cleaned at least once a month and more frequently if necessary in order
for it to operate correctly.
Only staff members qualified by the company are authorised to clean the SST-HD. Staff
members who are responsible for cleaning the SST-HD must be familiar with how it works,
its documentation and the safety instructions in particular.
The cleaning procedure is as follows:
• Switch the SST-HD to maintenance mode
• Transfer the bags to another storage unit which is in operation
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• Use a spray product chemically compatible with the SST-
HD component materials, which both cleans and disinfects
Rub with a soft cloth
•
• Verify the condition of the trays during reassembly. They must not be cracked,
worn or dirty!
Important! To clean the SST-HD and maintain it in good working condition, we recommend
following the instructions below.
Always switch the SST-HD to “Maintenance” mode before cleaning
Never use unsuitable cleaning tools (high-pressure washers, pressurised
water or water jets) as there is a risk of damage to the equipment
Never use cleaning products containing:
-Acids or halogen compounds (chlorides, bromides, halides)
-Strongly acidic salts such as formic acid or sulphonic amino acid descalers
- Drain unblockers, hydrochloric acid, silver cleaners
- Chlorine
- Abrasive compounds or scourers (scouring powder, steel wool)
- Polishing products, waxes, bleaching agents
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Always follow the cleaning product manufacturers’ instructions regarding
temperature, dosage, acting time, etc.
After completing all cleaning operations, check that the device is operational.
6 First-level maintenance.
This chapter describes the actions you may be required to perform if a first-level fault occurs
during use of the SST-HD.
Table 1 – Symptoms or faults: Overview
Symptoms or Faults
Illustration
Actions required
Flashing red indicator on
the front of a satellite
Potentially no tray may be
detected in the position under
which the red
is
displayed
indicator
Red indicator on the front
of a satellite
a
There
may
communication
(>4
minutes) or an electrical fault
on the antennas and satellite
be
fault
If there is a tray:
➢ Check
that
positioned
the
tray
is correctly
➢ If the problem persists, transfer the
tray’s contents to an operational tray
and inform the member of staff in
charge of maintenance
that
corrective maintenance can be carried
out
so
Transfer its contents to an operational tray
and inform the member of staff in charge of
maintenance so that corrective maintenance
can be carried out.
(See Table 2 – Symptoms or faults: Red
indicator on the satellite)
Red indicator on the front
of the processor
Inform the member of staff in charge of
maintenance so that corrective maintenance
can be carried out.
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Red and green indicators
the
the
on
processor
front of
Inform the member of staff in charge of
maintenance so that corrective maintenance
can be carried out.
* In the event of a failure, RFID traceability may be interrupted. This interruption is referred to in the
product’s event log.
When a red LED appears, try to detect the cause of the fault and eliminate it as quickly as
possible.
Table 2 – Symptoms or faults: Red indicator on the satellite
Red indicator on satellite
Possible causes
Data cannot be written
The tray has been open for more than 4
minutes
Close the tray
Actions
Move the bag to a different space and try again
Communication with processor lost
Inform the member of staff in charge of
maintenance so that corrective maintenance
can be carried out.
Failure to observe any of the recommendations will void the warranty.
7 Warranty
8 Transport
When receiving the SST-HD, verify that it has not been damaged during transport.
If you notice any transport-related anomalies, immediately contact your carrier or retailer
and show them the delivery note or purchase order.
The required transport conditions are determined by Biolog-id. They must be respected to
preserve the physical integrity of the device.
9 Manufacturer liability
The manufacturer shall not be held liable in the following cases:
▪ Failure to observe the manufacturer’s installation recommendations.
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▪ Work or repairs carried out by persons who have not been authorised by the
▪ Using the device as part of an electrical installation that does not comply with
manufacturer.
applicable regulations.
▪ Using the device for purposes other than those specified in this manual
▪ Using accessories (RFID tags, temperature probe, etc.) other than those supplied
by Biolog-id
10 Service life
The service life of the device under recommended usage and maintenance conditions is 10
years.
11 Disposal and recycling
The SST-HD must be disposed of and recycled in accordance with applicable national
requirements. The different components of the SST-HD must be sorted and processed in the
appropriate waste processing channels.
As the different components of the SST-HD are electrical and electronic, they must be
processed by a specialised collection, removal and recycling or destruction channel.
The batteries in the SST-HD components must be removed from the components before
being disposed of. They must be processed by a specialised collection, removal and recycling
or destruction channel.
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12 Product identification
PRD717_0100A label:
PRD717_0200A label:
Detailed view of serial number xxBIAASSNNNNNN
Product version: 2 characters
Supplier index: 2 letters: BI (index allocated to each supplier and provided by BIOLOG_ID: BI
represents Biolog-Id).
Year: 2 characters: 00 to 99: 16 represents 2016.
Week: 2 characters: 01 to 53: 45 represents week 45
Serial number: 6 characters: 000001 to 999999
Only reset to 1 when the maximum value is reached or in accordance with Biolog-Id’s
instructions
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13 Description of the logos
: Read the user manual.
: This product is FCC compliant
: This product is CE-compliant.
: This product is NRTL-compliant.
: This product emits an electromagnetic field.
: This product is manufactured at the address shown
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1 | Product Label | ID Label/Location Info | 213.65 KiB | January 15 2021 / January 18 2021 |
Etiquette d'identification PRD_7170200A version USA et CANADA :
Medical Device Class I 1 rue du commandant Robert Malrait ZA des Granges 27 300 BERNAY - FRANCE Smart Storage Refrigerator High Density REF PRD_7170200A SN 01BI2018000056 FCC ID : 2AKUFSSTHD60 IC : 23919-SSTHD60 UDI *XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX*
This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) this device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. Etiquette d'identification PRD_7170205A version USA et CANADA :
Medical Device Class I 1 rue du commandant Robert Malrait ZA des Granges 27 300 BERNAY - FRANCE Smart Storage Refrigerator High Density REF PRD_7170205A SN 01BI2018000058 FCC ID : 2AKUFSSTHD60 IC : 23919-SSTHD60 UDI *XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX*
This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) this device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation.
1 | Product Label Location | ID Label/Location Info | 406.33 KiB | January 15 2021 / January 18 2021 |
Technical Documentation Label Location FCC ID IC 2AKUFSSTHD60 23919-SSTHD60 Publication History Version 01 Date October 2, 2020 Modification description Creation of the document Technical Documentation Label Location The identification label is place on the calculator box. Label Location View Version : 01 Page 2/2
1 | Confidentiality Request Letter | Cover Letter(s) | 535.41 KiB | January 15 2021 / January 18 2021 |
biologid Connecting healthcare to empower people Biolog-ld 1, rue du commandant Robert Malrait 27 300 Bernay, FRANCE To: Federal Communications Commission 7435 Oakland Mills Road Columbia, MD 21046-1609 Curtis-Straus LLC TCB One Distribution Center Circle, #1 Littleton, MA 02702 Re: Confidentiality Request Ladies and Gentlemen:
Permanent Confidentiality:
This letter is to comply with 47 CFR 0.457(d)(2) and 0.459 pertaining to confidential material. BIOLOG-ID requests that the following documents regarding this submission for FCC ID: 2AKUFSSTHD60 be kept confidential:
1. Schematics 2. Block Diagram 3. Circuit/Technical Description 4. Part List The material above contains technical data, which would customarily be guarded from competitors. Short-term Confidentiality:
This request for confidentiality is made pursuant to 47 CFR 0.457(d)(2) and 0.459 of FCC rules. BIOLOG-ID requests that the following documents regarding this submission for FCC ID: 2AKUFSSTHD60 are kept confidential for a period of 180 days from the date of the Grant of Equipment Authorization. 1. Internal Photos 2. User manuel The material above contains technical data, which would customarily be guarded from competitors. Sincerely, BRUNO CHAPPE CEO ORG, VE AG) CERTIFICAT DE. __Etablissement Principal: 1, tue du Commandant Robert Malrait ZA des Granges - BP 30303 - 27303 BERNAY CEDEX - FRANCE Ghd untbrBaceen sie QUALITE Tl. : +33(0)2 32 47 83 40 - Fax : +33(0)2 32 47 83 50 - R.C.S. PARIS B 481 216 430 00027 4 Web : www.biolog-id.com / Email : commercial@biolog-id.com 4
-sgs. !SO 9001 ~, Sige social : 46-48 Avenue du Gnral LECLERC 92100 BOULOGNE-BILLANCOURT - FRANCE - S.A.S. au capital de 7 017 533 Libert + Egalit + Fraternit R.C.S. PARIS B 481 216 430 000 35 / NAF 2733Z - N T.V.A. FR 48 481 216 430 - NEORI FR481216430 00035 REPUBLIQUE FRANCAISE
1 | Product Certification Representative Auth Letter | Cover Letter(s) | 385.13 KiB | January 15 2021 / January 18 2021 |
biologid Connecting healthcare to empower people Biolog-Id 1, rue du commandant Robert Malrait 27 300 Bernay, FRANCE To: Federal Communications Commission 7435 Oakland Mills Road Columbia, MD 21046-1609 Date: January 12, 2020 To Whom It May Concern:
Ladies and Gentlemen:
We, the undersigned, hereby authorize Zorica COROLLEUR, Engineer Certification, at LCIE Bureau Veritas to act on our behalf in all matters relating to application for equipment authorization FCC ID: 2AKUFSSTHD60 including the signing of all documents related to this matter. Any and all acts carried out by our authorized agent shall have the same effect as acts of our own. For instances where our authorized agent signs the applications on our behalf, we acknowledge that all responsibility for complying with the relevant terms and conditions still resides with us. We also hereby certify that no party to this application is subject to a denial of benefits including FCC benefits, pursuant to Section 5301 of Anti-drug Abuse Act of 1988, 21 U.S.C 862. Sincerely, BRUNO CHAPPERT IRGANISME PRIVE AGREE TE _ CERTIFICAT DE Etablissement Principal : 1, rue du Commandant Robert Malrait ZA des Granges - BP 30303 - 27303 BERNAY CEDEX FRANCE Chbir e67 RecauaGain if UALITE Tl. : +33(0)2 32 47 83 40 - Fax : +33(0)2 32 47 83 50 - R.C.S. PARIS B 481 216 430 00027 Q Web : www.biolog-id.com / Email : commercial@biolog-id.com
% 9
"ss. SO 9001 Sige social : 46-48 Avenue du Gnral LECLERC 92100 BOULOGNE-BILLANCOURT - FRANCE - S.A.S. au capital de 7 017 533 Libert Libert Egalit Fraterit Fraternit REPUBLIQUE FRANCAISE R.C.S. PARIS B 481 216 430 000 35 / NAF 2733Z - N T.V.A. FR 48 481 216 430 - NEORI FR481216430 00035
1 | Product Family Letter | Cover Letter(s) | 507.22 KiB | January 15 2021 / January 18 2021 |
PRODUCT FAMILY SST-R HD Smart Storage High Density kits for blood bank Refrigerators SST-R HD kits SST-R HD kits are part of the Biolog-id Inventory solution. They are designed for real-time inventory management of large quantities of Red Blood Cell concentrates (RBCs) into blood bank refrigerators and walk-in cold rooms. Technical Specifications of product family:
FCC ID:
IC:
2AKUFSSTHD60 23919-SSTHD60 Models Kit Designation PRD_7170205A PRD_7170200A SST-R HD360 SST-R HD432 Storage Capacity per kit (RBC bags1) 360 Integration into Refrigerator Storage Capacity per drawer (RBC bags1) Storage Capacity per shelf (RBC bags1) Number of Shelves 18 72 5 Drawer internal size (W x D x H mm) 119 x 556 x 120 mm Footprint2 (W x D x H mm) 579 x 610 x 1250 Kit weight3 Power Supply 90Kg 100 240 VAC 432 Cold-room 18 72 6 750 x 750 x 1900
(Kit incl. cold-room frame) 200Kg
(incl. cold-room frame) 1 RBC bags: Standard Red Blood cell Concentrate bags (20mm thickness) 2 Footprint: Minimum space needed to retrofit a storage cabinet. 3 Weight: weight of an empty kit (including drawers, RFID satellites) SST-RHD_EN_F02
frequency | equipment class | purpose | ||
---|---|---|---|---|
1 | 2021-01-18 | 13.56 ~ 13.56 | DXX - Part 15 Low Power Communication Device Transmitter | Original Equipment |
app s | Applicant Information | |||||
---|---|---|---|---|---|---|
1 | Effective |
2021-01-18
|
||||
1 | Applicant's complete, legal business name |
Biolog-id
|
||||
1 | FCC Registration Number (FRN) |
0027223015
|
||||
1 | Physical Address |
1 rue du commandant Robert Malrait
|
||||
1 |
Bernay, N/A
|
|||||
1 |
France
|
|||||
app s | TCB Information | |||||
1 | TCB Application Email Address |
c******@bureauveritas.com
|
||||
1 | TCB Scope |
A1: Low Power Transmitters below 1 GHz (except Spread Spectrum), Unintentional Radiators, EAS (Part 11) & Consumer ISM devices
|
||||
app s | FCC ID | |||||
1 | Grantee Code |
2AKUF
|
||||
1 | Equipment Product Code |
SSTHD60
|
||||
app s | Person at the applicant's address to receive grant or for contact | |||||
1 | Name |
B**** C********
|
||||
1 | Title |
CEO
|
||||
1 | Telephone Number |
06703******** Extension:
|
||||
1 | Fax Number |
02324********
|
||||
1 |
b******@biolog-id.com
|
|||||
app s | Technical Contact | |||||
n/a | ||||||
app s | Non Technical Contact | |||||
n/a | ||||||
app s | Confidentiality (long or short term) | |||||
1 | Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | Yes | ||||
1 | Long-Term Confidentiality Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | Yes | ||||
1 | If so, specify the short-term confidentiality release date (MM/DD/YYYY format) | 07/17/2021 | ||||
if no date is supplied, the release date will be set to 45 calendar days past the date of grant. | ||||||
app s | Cognitive Radio & Software Defined Radio, Class, etc | |||||
1 | Is this application for software defined/cognitive radio authorization? | No | ||||
1 | Equipment Class | DXX - Part 15 Low Power Communication Device Transmitter | ||||
1 | Description of product as it is marketed: (NOTE: This text will appear below the equipment class on the grant) | Smart Storage Refrigerator High Density | ||||
1 | Related OET KnowledgeDataBase Inquiry: Is there a KDB inquiry associated with this application? | No | ||||
1 | Modular Equipment Type | Does not apply | ||||
1 | Purpose / Application is for | Original Equipment | ||||
1 | Composite Equipment: Is the equipment in this application a composite device subject to an additional equipment authorization? | No | ||||
1 | Related Equipment: Is the equipment in this application part of a system that operates with, or is marketed with, another device that requires an equipment authorization? | No | ||||
1 | Is there an equipment authorization waiver associated with this application? | No | ||||
1 | If there is an equipment authorization waiver associated with this application, has the associated waiver been approved and all information uploaded? | No | ||||
app s | Test Firm Name and Contact Information | |||||
1 | Firm Name |
LCIE Etablissement Sud-Est
|
||||
1 | Name |
A******** M****
|
||||
1 | Telephone Number |
00-33********
|
||||
1 | Fax Number |
00-33********
|
||||
1 |
a******@bureauveritas.com
|
|||||
Equipment Specifications | |||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
1 | 1 | 15C | 13.56000000 | 13.56000000 |
some individual PII (Personally Identifiable Information) available on the public forms may be redacted, original source may include additional details
This product uses the FCC Data API but is not endorsed or certified by the FCC