Biolog id SSTRBIOLOGID RFID BLOOD TRAKING SYSTEM User Manual Users manual

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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
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Table of Contents
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
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
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
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
Cleaning instructions ................................................................................................................. 24
First level maintenance. ............................................................................................................ 26
Warranty................................................................................................................................... 27
Transport .................................................................................................................................. 28
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Manufacturer liability................................................................................................................ 28
10 Service life................................................................................................................................. 28
11 Disposal and recycling ............................................................................................................... 28
12 Product identification................................................................................................................ 29
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1 General 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
at support@biolog-id.com
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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.
2 Overview 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.
PROCESSOR
DRAWERS
Fig. Example of an SST-R Kit
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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
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0 to 40°C
Operating temperature
(Power supply: -25°C to +40°C)
SST-R Kit: -10°C to 40°C
Special recommendations must be followed when
storing the following two components:
Battery:
Storage temperature
1 year: -20°C to 25°C
3 months: -20°C to 45°C
1 month: -20°C to 60°C
Button cell: CR2032
Operating humidity
Recommendation: +10°C to +25°C
(do not exceed 30°C)
40% RH to 95% RH
40% RH to 95% RH
Maximum storage humidity
(CR2032 button cell Recommendation: 40% RH to 95%
RH)
Atmospheric pressure
700hPa
Min / Max
1060hPa
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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
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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.
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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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Drawer satellites provide RBC bag location.
A satellite is installed beneath each drawer. Satellites consist of a sub-assembly of RFID
antennas that communicate with the RFID (Tag) in the RBC bag label.
The RFID system operates on the principle of a transponder (tags, RFID labels, etc.) and an
interrogator (coupler). The interrogator is an active radiofrequency emitter which activates
the RFID labels located in the space 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 tag responds. A simple command might involve returning the number of donations
corresponding to a unique identifier.
2.3.5
Temperature probe.
The temperature probe integrated into the SST-R is a sealed unit. It is used to measure zone
temperatures.
Fig. temperature probe
The only reference temperature is that provided by the controlled climate chamber. The
SST-R makes no claims as to temperature-related performance.
The SST-R temperature reading is for information only. This function is unrelated to cold
chain maintenance security.
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2.4 Hardware and software compatibility
This chapter details the third party hardware and software that is compatible with the SST-R.
2.4.1 Refrigerator.
The SST-R is compatible with the refrigerators listed in the table below:
Refrigerator
Angelantoni BBR 700
B Medical System BR 750
B Medical System BR 490
B Medical System BR 410
B Medical System BR 250
SST-R range
4x3
5x3
4x2
4x2
4x2
Number of
drawers
15
15
14
11
Maximum
number of bags
180
225
112
88
40
Depending on which type of refrigerator is used, three drawer combination ranges may be
available:
ü 2 rows of 4 spaces (8 spaces / 4x2)
ü 3 rows of 4 spaces (12 spaces / 4x3)
ü 3 rows of 5 spaces (15 spaces / 5x3)
The system is designed to provide 1 to 15 drawers.
The device must not be overloaded.
2.4.2 Cold room.
The SST-R is compatible with all RBC bag storage cold rooms. When used in this way, the
SST-R is installed using the specific cold room fixing kit.
(Demonstrate whether or not cold room testing is required)
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2.4.3 RFID label.
Fig. RBC bag and RFID tag
Fig. RFID label and blood bag
The RFID label stores the product and patient data and RBC bag tracking data.
The following passive RFID labels are compatible with the SST-R:
TBC + DIMENSIONS + supplier reference (PARAGON, etc.)
Supplier ref
TAG_HF_100E1PS140_1R_75SLIS45
Dimensions
TAG_HF_102E1AI102_R5_31SLIS16
TAG_HF_102E1AI102_R5_50LRI2K50
TAG_HF_102E1PI102_R5_31SLIS16
TAG_HF_ETI4"X4"_RW_SLI_S
TAG_HF_INA47X47_RW_SLI_S
TAG_HF_INA52X52_RW_LRI2K
TAG_HF_INA55X55_RW_LRI2K
TAG_HF_INA55X55_RW_SLI_S
TAG_HF_INI34X20_RW_SLI_S
TAG_HF_INI45X20_RW_LRI2K
TAG_HF_INW34X20_RW_SLI_S
TAG_HF_PA43X34X20_RW_LRI2K
TAG_HFIN34X20_RWBS_SLI_S
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2.4.4 Third party software.
The SST-R can link to third party programs and communicate over their web service to
share/exchange RBC bag tracking data (using a standard communication protocol). The third
party program can therefore ask the SST-R to write data to the RFID label memory.
Before this type of software is used, its compatibility will be validated.
The third party system is responsible for interpreting the data received by the SST-R.
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3 Using the Smart Storage Fridge (SST-R).
The purpose of this chapter is to show how the SST-R works.
3.1 How to place the RBC bags in the SST-R:
1 - Open a drawer
2 - Place the RBC bag in the drawer with the tube folded
beneath it*
*For better visibility, we recommend
putting the bag label on top.
3 - LEDs showing blue*: indicates which spaces are
available in a drawer.
*In this SST-R model, this function is only applicable if a third party system is linked to the web
service.
Please note: In diagnostic mode (RFID and LED operation verification), the front of the
drawer flashes
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3.2 Using the processor:
The processor is located outside the refrigerated chamber. There are three types of LED on
the front of the processor and their meanings are explained in this chapter.
Steady green LED: The processor is in normal
operating mode and is functioning normally.
Flashing green LED: The processor is in
maintenance operating mode and is
functioning normally.
Steady orange LED: The battery is fully charged
Flashing orange LED: The battery is charging.
Orange LED + red LED
Steady red LED: The processor is either in non-functional
mode (faulty) or it is disconnected from the network.
Please refer to Chapter 6 - 1st level maintenance in this
manual
Steady green and red LED: Network disconnected.
Green LED + red LED
Green LED only
Please refer to Chapter 6 - 1st level maintenance in this
manual
Green LED only: 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
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A battery integrated into the processor box provides backup power to keep the RFID
electronic surveillance functions working for less than 2 hours.
4 Safety instructions.
This chapter provides a detailed description of the safety instructions to apply when using
the SST-R.
Please pay special attention to these instructions
4.1 General safety instructions.
• Ensure that the installation and settings work is carried out by qualified
personnel. Operations carried out by personnel lacking the requisite skills
could impact the performance of the device and cause personal injury or
equipment damage.
• Only qualified customer service technicians are authorised to carry out
maintenance operations and repairs.
• Make sure that the connecting cable is not trapped or kinked during
installation or when moving the device.
• The SST-R must be positioned in such a way that the disconnection
mechanism is difficult to use.
• Never dismantle or modify any of the system components after the
installation has been validated
• Never place any objects other than blood bags in a drawer
• Never lean on a drawer
• The SST-R must not be stored or used outside the temperature and
atmospheric pressure ranges specified in this manual (Chapter 2.2)
• Never cover the SST-R drawers and/or obstruct the air vents.
• The SST-R must be fixed in such a way as to prevent it from being
dismantled without tools (for maintenance purposes).
• To prevent short-circuiting or oxidisation of the metal parts, never allow
water or any other liquid to penetrate into the device
• Use of the SST-R is restricted to trained personnel who are qualified to work
in a medical environment.
• Unless carrying out maintenance (see the installation and maintenance
manual), never unplug the electrical power supply (220V AC/12V DC), never
disconnect the connecting cables between the drawers and never disconnect
the Ethernet network cable.
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• The SST-R must only be used with original accessories and spare parts
because these are the only accessories/spare parts whose reliability, safety
and compatibility with our medical device are controlled
• Always follow the instructions shown on the safety labels affixed to the SSTR (see Chapter XXXX).
• The safety instructions affixed to the SST-R or beside it must remain legible
and complete throughout the period the product is in use. If the safety labels
become discoloured or are damaged during the service life of the SST-R,
please inform Biolog-id customer support (support@biolog-id.com).
• The SST-R must be installed in a refrigerator which is stable and equipped with an anti-
tipping system (this generally requires it to be fixed to a wall).
• Never push the SST-R.
• Never sit on a drawer.
• Never climb onto or walk on a drawer.
RISK
SAFETY INSTRUCTIONS
Contamination
Follow the cleaning instructions.
Operators must undergo authorised Biolog-id training so that they
know how the product works, are familiar with the documentation and
in particular, are aware of the safety instructions.
The electrical supply connecting cables must be installed in accordance
with applicable national regulations.
The machine-specific electrical voltages must be noted and the voltages
on the data plates must be compared with the voltages available at the
installation location before the installation is connected.
The machine wiring diagrams must be followed.
The device must be connected to a socket with a Circuit Protective
Conductor*
To prevent the system from developing a fault 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 other electrical devices.
Handling
Electrical
Electrical
Electrical
Electrical
Electrical
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Mechanical
Mechanical
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SAFETY INSTRUCTIONS
Before connecting and commissioning the machine, check that the
power 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-R
Only pull out the drawers using the handles provided
4.2 RF radiation hazards.
The SST-R electronic system antennas each emit a frequency of 13.56 MHz
with a power output of 200 mW (the law applicable to the design of RFID
readers prohibits a power output over 2 W).
MEDICAL ELECTRICAL DEVICES require special EMC precautions. The SST-R
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 the 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
on top of 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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Directives and manufacturer declaration - electromagnetic emissions
The PRD-7130100C, PRD-7130110C, PRD-7130120C and PRD-7130130C models are designed to be used in the
electromagnetic environment specified below. PRD-7130100C, PRD-7130110C, PRD-7130120C and PRD-7130130C
customers or users must ensure that their devices are used in such an environment.
Emissions test
Compliance
RF emissions
CISPR11
Group 1
RF emissions
CISPR11
Harmonic emissions
CEI 61000-3-2
Voltage fluctuations/
Flicker
CEI 61000-3-3
Class B
Class B
Electromagnetic environment - directives
The PRD-7130100C, PRD-7130110C, PRD-7130120C and PRD7130130C models only use RF energy for internal functions.
As a result, RF emissions are extremely low and are unlikely
to cause interference in nearby electronic devices.
The PRD-7130100C, PRD-7130110C, PRD-7130120C and PRD7130130C models are suitable for use in all buildings,
including domestic and those connected directly to the
public low-voltage electrical power supply network that
supplies power to domestic dwellings.
Compliant
Directives and manufacturer declaration - electromagnetic immunity
The PRD-7130100C, PRD-7130110C, PRD-7130120C and PRD-7130130C models are designed to be used in the
electromagnetic environment specified below. PRD-7130100C, PRD-7130110C, PRD-7130120C and PRD-7130130C
customers or users must ensure that their devices are used in such an environment.
Test level
CEI 60601
Immunity test
Electrostatic
discharges
(ESD)
CEI 61000-4-2
Fast
transient bursts
CEI 61000-4-4
Transient
overvoltages
CEI 61000-4-5
Voltage dips, short
outages and voltage
fluctuations in the
electrical power supply
input lines
CEI 61000-4-11
Level of
compliance
± 6 kV on contact
± 8 kV into the air
± 6 kV on contact
± 8 kV into the air
± 2 kV for electrical
supply lines
± 1 kV for
input/output lines
± 1 kV between
phases
± 2 kV between
phase and earth
<5% UV
(>95% UV dip) for
0.5 cycles
<40 % UV
(60 % UV dip) for 5
cycles
<70% UV
(30% UV dip) for 25
cycles
<5% UV
(>95% UV dip) for 5
seconds
± 2 kV for electrical
supply lines
± 1 kV for input/output
lines
± 1 kV between phases
± 2 kV between phase
and earth
Magnetic field at the
electrical network
frequency (50/60 Hz)
3 A/m
<5% UV
(>95% UV dip) for 0.5
cycles
<40 % UV
(60 % UV dip) for 5
cycles
<70% UV
(30% UV dip) for 25
cycles
<5% UV
(>95% UV dip) for 5
seconds
3 A/m
Electromagnetic environment - directives
The floors must be made of wood, concrete or
ceramic tiles. If the floors are covered with
synthetic material, relative humidity must be
at least 30%.
The quality of the electrical power supply
network must equate to that in a typical
commercial or hospital environment.
The quality of the electrical power supply
network must equate to that in a typical
commercial or hospital environment.
The quality of the electrical power supply
network must equate to that in a typical
commercial or hospital environment. If a PRD7130100C, PRD-7130110C, PRD-7130120C or
PRD-7130130C user requires continuous
operation during electrical power supply
network outages, we recommend connecting
the PRD-7130100C, PRD-7130110C, PRD7130120C or PRD-7130130C to an
uninterruptible power supply or battery.
Magnetic fields at the electrical network
frequency must be at levels that are
characteristic of a typical commercial or
hospital environment.
CEI 61000-4-8
NOTE UV is the voltage of the AC network before application of the test level.
Directives and manufacturer declaration - electromagnetic immunity
The PRD-7130100C, PRD-7130110C, PRD-7130120C and PRD-7130130C models are designed to be used in the
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electromagnetic environment specified below. PRD-7130100C, PRD-7130110C, PRD-7130120C and PRD-7130130C
customers or users must ensure that their devices are used in such an environment.
Immunity test
Test level
According to CEI
60601
Level of
compliance
Electromagnetic environment - directives
Portable or mobile RF communication devices must not be
used any closer than the recommended separation
distance from any part of the PRD-7130100C, PRD7130110C, PRD-7130120C or PRD-7130130C, including the
cables, as calculated using the applicable equation for the
emitter frequency.
Emissions Conducted RF
CEI 61000-4-6
3 Veff
150 kHz to 80 MHz
3V
Recommended separation distance
d = 1.17 √ P
d = 1.17 √ P
d = 2.34 √ P
Emissions Radiated RF
CEI 61000-4-3
3V
80 MHz to 2.5 GHz
3V
80 MHz to 800 MHz
800 MHz to 2.5 GHz
where P is the maximum characteristic power output of
the emitter in Watts (W) as provided by the manufacturer
of the emitter, and d is the recommended separation
distance in metres (m).
The strength of the fixed RF emitter fields, determined by
carrying out an electromagnetic survey on site ᵃ, must be
below the compliance level in each of the range of
frequencies. ᵇ
Interference can be caused by proximity to devices
marked with the following symbols:
NOTE 1 At 80 MHz and at 800 MHz, the highest range of frequencies is applicable.
NOTE 2 These directives might not be applicable to all situations. Electromagnetic propagation is affected by absorption and
reflections of structures, objects and persons.
ᵃ The strength of the fixed emitter fields such as radiotelephone base stations (cellular/cordless), mobile terrestrial radios,
amateur radios, AM and FM radio transmitters and TV transmitters cannot be calculated theoretically with any degree of
accuracy. To assess the electromagnetic environment due to fixed RF emitters, an on-site electromagnetic survey must be
carried out. If the strength of the field measured at the location in which the PRD-7130100C, PRD-7130110C, PRD-7130120C
or PRD-7130130C is used exceeds the applicable RF compliance level set out above, the PRD-7130100C, PRD-7130110C,
PRD-7130120C or PRD-7130130C must be monitored to check that it is operating normally. If the PRD-7130100C, PRD7130110C, PRD-7130120C or PRD-7130130C is observed to be performing abnormally, additional measures may be needed
such as re-orientating or repositioning it.
ᵇ The field strength over the range 150 kHz to 80 MHz must be lower than 3 V/m.
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Recommended separation distances between portable and mobile RF communication devices and the PRD-7130100C,
PRD-7130110C, PRD-7130120C or PRD-7130130C
The PRD-7130100C, PRD-7130110C, PRD-7130120C and PRD-7130130C models are designed to be used in electromagnetic
environments in which radiated RF emissions are controlled. PRD-7130100C, PRD-7130110C, PRD-7130120C and PRD7130130C customers and users can help prevent electromagnetic interference by maintaining a minimum distance between
portable and mobile RF communication devices (emitters) and the PRD-7130100C, PRD-7130110C, PRD-7130120C or PRD7130130C, as recommended below and in accordance with the maximum emitted power of the communication devices in
question.
Maximum assigned output power
Separation distance according to emitter frequency
150 kHz to 80 MHz
80 MHz to 800 MHz
800 MHz to 2.5 GHz
of the emitter
d = 1.17 √ P
d = 1.17 √ P
d = 2.34 √ P
0.01
0.1
0.37m
0.37m
0.74m
10
100
In the case of an emitter whose assigned maximum output power is not given above, the recommended separation
distance d in metres (m) can be estimated using the applicable equation for the emitter frequency, where P is the maximum
characteristic power output of the emitter in Watts (W) according to its manufacturer.
NOTE 1 At 80 MHz and at 800 MHz, the separation distance for the highest range of frequencies is applicable.
NOTE 2 These directives might not be applicable to all situations. Electromagnetic propagation is affected by absorption and
reflections of structures, objects and persons.
Directives and manufacturer declaration - electromagnetic immunity
The PRD-7130100C, PRD-7130110C, PRD-7130120C and PRD-7130130C models are designed to be used in the
electromagnetic environment specified below. PRD-7130100C, PRD-7130110C, PRD-7130120C and PRD-7130130C
customers or users must ensure that their devices are used in such an environment.
Test level
Level of
Electromagnetic environment - directives
Immunity test
CEI 60601
compliance
Electrostatic
± 6 kV on contact
± 6 kV on contact
The floors must be made of wood, concrete
discharges
± 8 kV into the air
± 8 kV into the air
or ceramic tiles. If the floors are covered with
(ESD)
synthetic material, relative humidity must be
CEI 61000-4-2
at least 30%.
Fast
± 2 kV for electrical
± 2 kV for electrical
The quality of the electrical power supply
transient bursts
supply lines
supply lines
network must equate to that in a typical
± 1 kV for
± 1 kV for input/output commercial or hospital environment.
CEI 61000-4-4
input/output lines
lines
Transient
± 1 kV between
± 1 kV between phases
The quality of the electrical power supply
overvoltages
phases
± 2 kV between phase
network must equate to that in a typical
CEI 61000-4-5
± 2 kV between
and earth
commercial or hospital environment.
phase and earth
Voltage dips, short
<5% UV
<5% UV
The quality of the electrical power supply
outages and voltage
(>95% UV dip) for
(>95% UV dip) for 0.5
network must equate to that in a typical
fluctuations in the
0.5 cycles
cycles
commercial or hospital environment. If a
electrical power supply <40 % UV
<40 % UV
PRD-7130100C, PRD-7130110C, PRDinput lines
(60 % UV dip) for 5
(60 % UV dip) for 5
7130120C or PRD-7130130C user requires
cycles
cycles
continuous operation during electrical power
CEI 61000-4-11
<70% UV
<70% UV
supply network outages, we recommend
(30% UV dip) for 25 (30% UV dip) for 25
connecting the PRD-7130100C, PRDcycles
cycles
7130110C, PRD-7130120C or PRD-7130130C
<5% UV
<5% UV
to an uninterruptible power supply or
(>95% UV dip) for 5 (>95% UV dip) for 5
battery.
seconds
seconds
Magnetic field at the
Magnetic fields at the electrical network
electrical network
frequency must be at levels that are
frequency (50/60 Hz)
3 A/m
3 A/m
characteristic of a typical commercial or
hospital environment.
CEI 61000-4-8
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NOTE UV is the voltage of the AC network before application of the test level.
The PRD-7130100C, PRD-7130110C, PRD-7130120C and PRD-7130130C models use 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.
Apparent power is 100 mW.
4.3 Contraindications
As a preventive measure, it is recommended that people fitted with pacemakers do not use
the SST-R. To be corroborated and added to the FMECA
4.4 Warning for users in United States
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.
- 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.
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.
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5 Cleaning instructions
This chapter explains the process to follow when cleaning the SST-R.
The device must be cleaned or disinfected before use.
The SST-R 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-R. Staff
members who are responsible for cleaning the SST-R must be familiar with how it works, its
documentation and the safety instructions in particular.
The cleaning procedure is as follows:
ü Switch the SST-R to maintenance mode
ü Move the bags into a different refrigerator
ü Use a spray product that is chemically compatible with the SST-R component
materials and cleans and disinfects. Rub with a soft cloth (ANIOS XXXX
cleaner)
Fig. 1. Apply the detergent disinfectant spray to the area to clean or to a non-woven wipe.
Fig.2. Spread the product evenly
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To clean the SST-R and maintain it in good working condition, we advise following the
instructions below.
Before cleaning the SST-R, always switch it to maintenance mode (cf HMI
manual). This rule also applies to maintenance operations.
The SST-R materials may be damaged if unsuitable cleaning tools, high
pressure washers, pressurised water or water jets are used.
Never use cleaning products containing the following:
-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
It is essential that the manufacturers’ instructions for the cleaning product
regarding temperature, dosage, acting time, etc. used are followed to the
letter.
After completing all the cleaning operations, check that the device works.
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6 First level maintenance.
This chapter explains the first level faults you might encounter when using the SST-R.
Actions to carry out
Red indicator on the
drawer fronts
Blood bag tracking may
no longer be possible in
the space showing a red
indicator
Red indicator on the
front of the processor
Red and green indicators
on the front of the
processor
1 Move the bag to a space
that works,
Inform the member of staff
in charge of maintenance
so that corrective
maintenance can be
carried out.
Inform the member of staff in
charge of maintenance so that
corrective maintenance can be
carried out.
Inform the member of staff in
charge of maintenance so that
corrective maintenance can be
carried out.
Change the image (consistency)
Requires updating
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Red drawer space LED
Possible causes
Action
Data cannot be written
The drawer has been open for longer than 4
minutes
Move the bag to a different space and try again
Close the drawer
Switch to maintenance mode, then restart the
processor
Communication with processor lost
Red processor LED
Possible causes
CAN bus communication lost
The CAN bus power supply has short-circuited
The processor probe has become disconnected
The Ethernet network has become
disconnected
Insufficient SD card memory
Power supply fault on at least one drawer
Battery charger fault
Action
Switch to maintenance mode and restart the
processor
Switch to maintenance mode and restart the
processor
Connect the temperature probe
Unplug the Ethernet cable and plug it back in again
Check that a notification has been sent to the third
party system. Contact the administrator.
Check that a notification has been sent to the third
party system. Contact the administrator.
Check that a notification has been sent to the third
party system. Contact the administrator.
When a red LED appears, try to detect the cause of the fault and eliminate it as quickly as
possible.
Contact the supplier of your device if it malfunctions.
Never carry out repairs or modifications without first obtaining authorisation from Biolog-Id.
Before carrying out any maintenance operations, the SST-R must be switched to
maintenance mode (cf HMI Manual).
7 Warranty
Failure to observe any of the recommendations will void the warranty.
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8 Transport
Check the device for damage when it is delivered.
If you notice any transport-related anomalies, immediately contact your carrier or retailer
and show them the delivery note or purchase order.
Required transport conditions: See the transport crate description (BC)
Manufacturer liability
The manufacturers cannot be held responsible in the following cases:
§ Failure to observe the manufacturer’s installation recommendations.
§ Work or repairs carried out by persons who are not authorised by the
manufacturer.
§ Using the device as part of an electrical installation that does not comply with
the applicable regulations.
§ Using the device for purposes other than those specified in this manual
§ Using accessories (tags, temperature probe, etc.) other than those supplied by
Biolog-Id
10 Service life
The service life of the device under recommended maintenance conditions is 10 years. After
this period, the device is no longer covered by the CE marking.
11 Disposal and recycling
Because the medical device is an item of electric and electronic equipment, it must be
disposed of using a company that specialises in waste collection, removal, recycling or
destruction.
The machine must be recycled in accordance with the applicable national requirements.
European Union legislation requires that member states collect and dispose of electrical and
electronic equipment separately from other unsorted communal waste.
Our devices fall into Category X as defined in directives 2002|95|EC (RoHS) and 2002|96|EC
(WEEE).
The product including the accessories, cells and batteries must not be disposed of as
recyclable waste.
The cells and batteries must be removed before the machine is disposed of or scrapped and
must be deposited in the specially provided local collection boxes.
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12 Product identification
The product label below is affixed to each processor box.
Detailed view of serial number BI 16450000XX
§
§
§
§
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 on Biolog-Id’s instructions.
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