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User manual - | Users Manual | 1.70 MiB | April 03 2019 / June 03 2019 | |||
1 | Cover Letter(s) | April 03 2019 / June 03 2019 | ||||||
1 | Cover Letter(s) | April 03 2019 / June 03 2019 | ||||||
1 | External Photos | April 03 2019 / June 03 2019 | ||||||
1 | Internal Photos | April 03 2019 / June 03 2019 | ||||||
1 | ID Label/Location Info | April 03 2019 / June 03 2019 | ||||||
1 | Operational Description | April 03 2019 / June 03 2019 | ||||||
1 | Test Report | April 03 2019 / June 03 2019 | ||||||
1 | Test Setup Photos | April 03 2019 / June 03 2019 |
1 | User manual - | Users Manual | 1.70 MiB | April 03 2019 / June 03 2019 |
Smart Storage Refrigerator User Manual Version: 5.0 SMART STORAGE REFRIGERATOR USER MANUAL 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 Manual validation date: 26/10/2018 1 of 34 Smart Storage Refrigerator User Manual Version: 5.0 Content 1 General user information. .............................................................................................................. 4 1.1 1.2 1.3 1.4 1.5 Purpose of the manual. .......................................................................................................... 4 Intended audience. ................................................................................................................. 4 Structure of the manual. ........................................................................................................ 4 User advice. ............................................................................................................................ 4 Documents supplementing this manual ................................................................................. 5 2 Presentation of the Smart Storage Refrigerator (SST-R). ............................................................... 5 2.1 2.2 2.3 Claimed use of the SST-R. ....................................................................................................... 5 Required environmental characteristics for SST-R operation. ............................................... 6 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 tag. ....................................................................................................................... 12 2.4.4 Third-party software...................................................................................................... 13 3 Using the Smart Storage Refrigerator (SST-R). ............................................................................. 14 3.1 3.2 Installation of the RBC bags in the SST-R and drawers indicator lights ............................... 14 Light indicators of the processor ........................................................................................... 15 4 Safety instructions. ....................................................................................................................... 16 4.1 4.2 4.3 4.4 General safety instructions. ................................................................................................. 16 RF radiation hazards. ............................................................................................................ 19 Electromagnetic compatibility: ............................................................................................. 20 Contraindications .................................................................................................................. 29 4.5 Warning for users in United States ....................................................................................... 29 5 6 Cleaning instructions ..................................................................................................................... 29 First-level maintenance. ............................................................................................................... 32 Manual validation date: 26/10/2018 2 of 34 Smart Storage Refrigerator User Manual Version: 5.0 7 Warranty........................................................................................................................................ 33 8 Transport ....................................................................................................................................... 33 9 Manufacturer liability .................................................................................................................... 33 10 Service life ..................................................................................................................................... 33 11 Disposal and recycling ................................................................................................................... 33 12 Product identification .................................................................................................................... 34 Manual validation date: 26/10/2018 3 of 34 Smart Storage Refrigerator User Manual Version: 5.0 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-R and how to maintain it properly 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 documentation on the SST-R for its entire service life. 1.2 Intended audience. This manual is intended for all users likely to carry out operations on the SST-R 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-R. One chapter is dedicated to general safety instructions. Please read this chapter carefully. 1.4 User advice. If you cannot find answers to questions linked to the operation or use of the SST-R, do not hesitate to contact us at the following email address support@biolog-id.com Manual validation date: 26/10/2018 4 of 34 Smart Storage Refrigerator User Manual Version: 5.0 1.5 Documents supplementing this manual The following is provided along with this user manual:
Installation and maintenance manual. Note that the SST-R 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 format only. 2 Presentation of the Smart Storage Refrigerator (SST-R). 2.1 Claimed use of the SST-R. The SST-R is a class I medical device used as a blood bank refrigerator/cold room accessory. It is a fixed device which can only be used inside this type of equipment. The SST-R is a Radio-Frequency Identification (RFID) product used to track packed red blood cell (RBC) bags. It improves the storage of red blood cells. The SST-R continuously communicates with the RFID tags affixed onto the RBC bags so that the history of every RBC bag is saved and accessible to users. The SST-R tracks all bag movements into and out of a refrigerator or cold room and displays a stock status. PROCESSOR DRAWERS Fig. Example of an SST-R Kit Manual validation date: 26/10/2018 5 of 34 Smart Storage Refrigerator User Manual Version: 5.0 The SST-R 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-R operation. The SST-R is designed to be used in a hospital environment by laboratory technicians who have been specifically 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. (See Chapter 2.4, Hardware and software compatibility). Fig. example of SST-R kit integration into a refrigerator Manual validation date: 26/10/2018 6 of 34 Smart Storage Refrigerator User Manual Version: 5.0 The SST-R-compatible blood bank refrigerator/cold room controls the climate-related aspects (temperature and moisture) of RBC product storage. The SST-R does not affect 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 Operating temperature 0 to 40C Storage temperature
(Power supply: -25C to +40C) SST-R kit: -10C to 40C Special recommendations must be followed when storing the following two components:
Battery:
1 year: -20C to 25C 3 months: -20C to 45C 1 month: -20C to 60C Button cell: CR2032 Operating humidity Maximum storage humidity Recommended: +10C to +25C
(do not exceed 30C) 40% RH to 95% RH 40% RH to 95% RH
(CR2032 button cell Recommendation: 40% RH to 95%
RH Atmospheric pressure Min/max 700hPa 1060hPa Manual validation date: 26/10/2018 7 of 34 Smart Storage Refrigerator User Manual Version: 5.0 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 Manual validation date: 26/10/2018 8 of 34 Smart Storage Refrigerator User Manual Version: 5.0 2.3.1 Processor and power supply. Fig. Processor and its power supply The processor in the SST-R system manages the data and queries and transfers information to higher-level applications such as third-party software. 2.3.2 Wiring harness. Fig. wiring harness A wiring harness supplies power to every drawer and carries data between the processor and the RFID antennas. Manual validation date: 26/10/2018 9 of 34 Smart Storage Refrigerator User Manual Version: 5.0 2.3.3 Drawer. Fig. drawer unit The drawer is a module used to store RBC bags. There are 3 ranges of drawers with different storage arrangements:
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6 spaces i.e. 2 rows of 3 spaces. 8 spaces i.e. 2 rows of 4 spaces. 12 spaces i.e. 3 rows of 4 spaces. 15 spaces i.e. 3 rows of 5 spaces. 2.3.4 Satellite. Manual validation date: 26/10/2018 10 of 34 Smart Storage Refrigerator User Manual Version: 5.0 Fig. satellite box The satellite associated with a drawer helps locate the RBC bags. A satellite is installed underneath every drawer. The satellite consists of a sub-assembly of RFID antennas which communicate with the RFID tag affixed to the RBC bag. The operating principle of the RFID system is based on a transponder (RFID tags) and an interrogator (coupler). The interrogator is an active radiofrequency emitter; these radio frequencies activate the RFID tags affixed onto the RBC 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. 2.3.5 Temperature probe. The temperature probe temperature of an area. integrated into the SST-R is waterproof. It measures the Fig. temperature probe Only the temperature of the temperature-controlled chamber is representative. 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. Manual validation date: 26/10/2018 11 of 34 Smart Storage Refrigerator User Manual Version: 5.0 2.4 Hardware and software compatibility This chapter details the third-party hardware and software compatible with the SST-R. 2.4.1 Refrigerator. The SST-R is compatible with some refrigerators listed by Biolog-id. For more information, please contact the quality service of Biolog-id at this adress :
quality@biolog-id.com Depending on which type of refrigerator is used, three drawer combination ranges may be available:
2 rows of 3 spaces (6 spaces / 3x2) 2 rows of 4 spaces (8 spaces / 4x2) 3 rows of 4 spaces (12 spaces / 4x3) 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. Before installing an SST-R in a cold room, Biolog-id conducts compatibility tests on the SST-R and the Cold room. 2.4.3 RFID tag. Fig. RFID tag and blood bag The RFID tag stores product and patient data as well as RBC bag tracking data. The passive RFID tags compatible with the SST-R are listed by Biolog-id. Manual validation date: 26/10/2018 12 of 34 Smart Storage Refrigerator User Manual Version: 5.0 The RFID chips have to stick on the label of the RBC bag. For each location, the tag must be positioned in a delimited central area as in the diagram below. Delimitation of the reading area (proportional to a location) RFID tags positioned between two zones or outside the red zone are not identified by the SST-R. For more information, please contact the quality service of Biolog-id at this adress :
quality@biolog-id.com 2.4.4 Third-party software. The SST-R can link to third-party programmes and communicate via their web service to share/exchange tracking data relating to RBC bags equipped with RFID tags. The third-party programme can therefore ask the SST-R 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 by the SST-R. Manual validation date: 26/10/2018 13 of 34 Smart Storage Refrigerator User Manual Version: 5.0 3 Using the Smart Storage Refrigerator (SST-R). The purpose of this chapter is to show how the SST-R works. Installation of the RBC bags in the SST-R and drawers indicator lights 1 - Open a drawer 3.1 2 - Place the RBC bag in the drawer with the tube folded beneath it*
*For better user visibility, we recommend putting the bag label on top. 3 - LEDs lighting up 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 diagnosis mode (RFID and LED operation verification), the front of the drawer flashes Manual validation date: 26/10/2018 4 - LED lighting up red on a space: Loss of RBC traceability in the space with a red LED. Please refer to Chapter 6 - First-level maintenance in this manual 14 of 34 Smart Storage Refrigerator User Manual Version: 5.0 3.2 Light indicators of 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. Red LED on (green LED off): The processor is in non-functional mode
(faulty). Please refer to Chapter 6 - First-level maintenance in this manual Green and red LEDs on: Network disconnected. Please refer to Chapter 6 - First-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 - First-level maintenance in this manual A battery integrated to the calculator keeps the monitoring functions of the RFID electronics functioning in case of power outage for at least 2 hours. Manual validation date: 26/10/2018 15 of 34 Smart Storage Refrigerator User Manual Version: 5.0 4 Safety instructions. This chapter provides a detailed description of the safety instructions applicable when using the SST-R. Please read these instructions carefully 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 may affect 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. Ensure 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 qualified to work in a medical environment. Unless carrying out maintenance (see installation and maintenance manual), never unplug the power supply (220V AC/12V DC), never disconnect the connecting cables between the drawers and never disconnect the Ethernet network cable. The SST-R 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-
R. 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 damaged during the service life of the SST-R, please inform Biolog-id customer support (support@biolog-id.com). Manual validation date: 26/10/2018 16 of 34 Smart Storage Refrigerator User Manual Version: 5.0 The SST-R must be installed in a refrigerator which is stable and equipped with an anti-
tipping system (this generally requires wall mounting). Never push the SST-R. Never sit on a drawer. Never climb onto or walk on a drawer. For the effective storage of products and optimal, safe use, the tubes must be folded beneath the bag. Example of storage with folded tubes It is forbidden to store products on the top cover. Manual validation date: 26/10/2018 17 of 34 Smart Storage Refrigerator User Manual Version: 5.0 RISK Contamination Handling Electrical Electrical Electrical Electrical Electrical SAFETY INSTRUCTIONS 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, more specifically, are aware of the safety instructions. Power supply connecting cables must be installed in accordance with applicable national regulations. Machine-specific electrical voltages must be taken into account and compared with 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 protection conductor 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 other electrical devices. RISK 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 fastenings. Ensure that only trained operators familiar with safety measures use the SST-R Only pull out the drawers using the handles provided Never vertically move the drawer handle when opening and closing the drawer. Electrical Mechanical Mechanical Never hang from the handles or drawers. Manual validation date: 26/10/2018 18 of 34 Smart Storage Refrigerator User Manual Version: 5.0 Open the drawers using the handles. Mechanical They must be handled with no sudden movements. 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 exceeding 2W). 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 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. Manual validation date: 26/10/2018 19 of 34 Smart Storage Refrigerator User Manual Version: 5.0 4.3 Electromagnetic compatibility:
in or best cords other electronic conditions transmitters SST-R different The SST-R complies with applicable electromagnetic compatibility standards, however, the user will ensure that any electromagnetic interference does not create an additional hazard, such as radiofrequency devices. In this chapter you will find necessary information to ensure an installation and a commissioning of compatibility. the The each other. Some types of mobile telecommunication devices such as mobile phones are likely to interfere with the SST-R. The separation distances recommended in this chapter must therefore be strictly observed. The SST-R 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-R. electromagnetic distant from terms SST-R must of be the of in The SST-R uses the frequency 13.56 MHz. The frequency band is 13.553 - 13.567Mhz compliant with ISO 15693. The modulation type is ASK, the RF mode is TX / RX. The apparent power is 100mW. The tables below are for the SST-R type:
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4x2 (PRD_7130100D), 4x3 (PRD_7130200C), 5x3 (PRD_7130300A). All the information below is based on the normative requirements to which the manufacturers of electromedical devices are subject, in the sense of the standard IEC60601-1-2 Ed3. Directives and manufacturer declaration - electromagnetic emissions The PRD-7130100D, PRD-7130200C, and PRD-7130300A models are designed to be used in the electromagnetic environment specified below. PRD-7130100D, PRD-7130200C, and PRD-7130300A customers or users must ensure that their devices are used in such an environment. Emissions test Compliance Electromagnetic environment - directives RF emissions CISPR11 RF emissions CISPR11 Harmonic emissions CEI 61000-3-2 Voltage fluctuations/
Flicker CEI 61000-3-3 Group 1 Class B Class B Compliant The PRD 7130100D, PRD-7130200C, and PRD-7130300A models only use RF energy for internal functions. As a result, RF emissions are extremely low and unlikely to cause interference in nearby electronic devices. The PRD-7130100D, PRD-7130200C, and PRD-7130300A 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. Manual validation date: 26/10/2018 20 of 34 Smart Storage Refrigerator User Manual Version: 5.0 Directives and manufacturer declaration - electromagnetic immunity The PRD-7130100D, PRD-7130200C, and PRD-7130300A models are designed to be used in the electromagnetic environment specified below. PRD-7130100D, PRD-7130200C, and PRD-7130300A customers or users must ensure that their devices are used in such an environment. Immunity test Electrostatic discharges
(ESD) CEI 61000-4-2 Fast transient bursts CEI 61000-4-4 Transient overvoltage CEI 61000-4-5 Voltage dips, short outages and voltage fluctuations on power supply input lines CEI 61000-4-11 Test level CEI 60601 6kV on contact Level of compliance 6kV on contact 8kV into the air 8 kV into the air 2kV for electrical supply lines 2kV for electrical supply lines 1kV for input/output lines 1 kV for input/output lines Electromagnetic environment - directives Floors must be made of wood, concrete or ceramic tiles. If floors are covered in synthetic materials, relative humidity should be at least 30%. The quality of the power supply network must be equivalent to that of a standard retail or hospital environment. 1 kV phase-to-
phase 2kV phase-to-
earth 1 kV phase-to-phase 2 kV phase-to-earth The quality of the power supply network must be equivalent to that of a standard retail or hospital environment. The quality of the power supply network must be equivalent to that of a standard retail or hospital environment. If a PRD-7130100D, PRD-7130200C, and PRD-7130300A user requires continuous operation during electrical power supply network outages, we recommend connecting the PRD-7130100D, PRD-7130200C, and PRD-7130300A to an uninterruptible power supply or battery.
<5% UV
<5% UV
(>95% UV dip) for 0.5 cycles
(>95% UV dip) for 0.5 cycles 40 % UV 40% UV
(60% UV dip) for 5 cycles
(60% UV dip) for 5 cycles 70% UV 70% UV
(30% UV dip) for 25 cycles
(30% UV dip) for 25 cycles
<5% UV
<5% UV
(>95% UV dip) for 5 seconds
(>95% UV dip) for 5 seconds Power-frequency magnetic field (50/60 Hz) 3 A/m 3 A/m Power-frequency magnetic fields must remain at levels characteristic of a representative location in a typical retail or hospital environment. CEI 61000-4-8 NOTE UV is the voltage of the AC network before application of the test level. Manual validation date: 26/10/2018 21 of 34 Smart Storage Refrigerator User Manual Version: 5.0 Directives and manufacturer declaration - electromagnetic immunity The PRD-7130100D, PRD-7130200C, and PRD-7130300A models are designed to be used in the electromagnetic environment specified below. PRD-7130100D, PRD-7130200C, and PRD-7130300A customers or users must ensure that their devices are used in such an environment. Immunity test According to CEI Test level Level of compliance 60601 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-7130100D, PRD-
7130200C, and PRD-7130300A, including the cables, as calculated using the applicable equation for the emitter frequency. 3 V Recommended separation distance d = 1.17 P d = 1.17 P 80MHz to 800MHz 3 V/m Conducted RF 3 Veff d = 2.34 P 800MHz to 2.5GHz emissions 150kHz to 80MHz CEI 61000-4-6 Radiated RF 3 V/m emissions CEI 61000-4-3 80 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 , must be below the compliance level in each of the range of frequencies. Interference can be caused by proximity to devices marked with the following symbols:
NOTE 2 These directives may not be NOTE 1 At 80 MHz and at 800 MHz, the highest range of frequencies is applicable. applicable to all situations. Electromagnetic propagation is affected by absorption and reflections from structures, objects and persons. 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-7130100D, PRD-7130200C, and PRD-
7130300A is used exceeds the applicable RF compliance level set out above, the PRD-7130100D, PRD-7130200C, and PRD-
7130300A must be monitored to check that it is operating normally. If the PRD-7130100D, PRD-7130200C, and PRD-
7130300A is observed to be performing abnormally, additional measures may be needed such as re-orientating or repositioning it. The field strength over the range 150 kHz to 80 MHz must be lower than 3 V/m. Manual validation date: 26/10/2018 22 of 34 Smart Storage Refrigerator User Manual Version: 5.0 Recommended separation distances between portable and mobile RF communication devices and the PRD-7130100D, PRD-7130200C, and PRD-7130300A The PRD-7130100D, PRD-7130200C, and PRD-7130300A models are designed to be used in electromagnetic environments in which radiated RF emissions are controlled. PRD-7130100D, PRD-7130200C, and PRD-7130300A customers and users can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communication devices (emitters) and the PRD-7130100D, PRD-7130200C, and PRD-7130300A, 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 the transmitter's frequency of the emitter 150kHz to 80MHz 80MHz to 800MHz 800MHz to 2.5GHz d = 1.17 P d = 1.17 P d = 2.34 P W 0.01 0.1 1 10 100 0.37m 0.37m 0.74m In the case of a transmitter whose assigned maximum output power is not indicated above, the recommended separation distance d in metres (m) can be estimated using the applicable equation for the transmitter frequency, where P is the maximum characteristic power output of the transmitter 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 may not be applicable to all situations. Electromagnetic propagation is affected by absorption and reflections from structures, objects and persons. 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 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. This device complies with Industry Canada RF radiation exposure limits set forth for general population. This device must be installed to provide a separation distance of at least 20cm from all persons and must not be co-located or operating in conjunction with any other antenna or transmitter. Manual validation date: 26/10/2018 23 of 34 Smart Storage Refrigerator User Manual Version: 5.0 The tables below are for SST-R 3x2 (PRD_7130400B). All the information below is derived from the normative requirements to which the manufacturers of electromedical devices are subject, in the sense of the standard IEC60601-
1-2 Ed4. Cable length:
Cables and accessories Maximum length Type of test Compliant with Power cable CAN cable Temperature probe cable Ethernet cable
< 3m
< 3m
< 3m
> 3m RF emission CISPR 11, Classe B Harmonic current emission IEC 61000-3-2 Fluctuation of Voltage and Flicker of Voltage Electrostatic discharge immunity Radiated Immunity -
Electromagnetic Fields Immunity to fast electrical transients in salvo IEC 61000-3-3 IEC 61000-4-2 IEC 61000-4-3 IEC 61000-4-4 Immunity to shock waves IEC 61000-4-5 Driving immunity -
Radiofrequency driving disturbance Radiated Immunity -
Magnetic Fields Immunity to voltage dips, short interruptions and voltage variations IEC 61000-4-6 IEC 61000-4-8 IEC 61000-4-11 Recommended separation distances :
The SST-R 3x2 is intended for use in an electromagnetic environment in which the disturbance due to RF radiation are controlled. The user or installer of the medical device can help to avoid electromagnetic interference by maintaining a minimum distance, depending on the maximum power of the radio frequency transmission equipment. RF portable communications equipment (including peripherals such as antenna cables and external antennas) should not be used closer than 30 cm (12 inches) to any part of the SST-R 3x2, including cables specified by the manufacturer. Otherwise, the performance of these devices may be altered. Manual validation date: 26/10/2018 24 of 34 Smart Storage Refrigerator User Manual Version: 5.0 Electromagnetic emissions The SST-R 3x2 is intended for use in the electromagnetic environment described in the table below. The user and the installer must therefore ensure that the SST-R 3x2 is used in the environment described below. Manual validation date: 26/10/2018 25 of 34 Emission test Electromagnetic radiation disturbance
(Radiated emissions)
(CISPR 11) Interference voltage at the power terminals
(Emissions conducted)
(CISPR 11) Harmonic current emission
(IEC61000-3-2) Voltage variations, voltage fluctuations and flicker Smart Storage Refrigerator User Manual Version: 5.0 Compliance Electromagnetic environment - remarks Group 1 The PRD_7130400B medical device uses RF energy for its internal function. Class B Compliant Compliant NA
(IEC61000-3-3) Magnetic and electromagnetic immunity The SST-R 3x2 is intended for use in the magnetic and electromagnetic environment described installer must ensure that the electromagnetic environment is compliant. in the table below. The user and the Immunity test Test level according to Level of compliance IEC60601 Electromagnetic environment / remarks Electrostatic discharge (ESD) 8 kV in contact
(IEC61000-4-2) Fast electrical transients in bursts
(IEC61000-4-4) 2 kV; 4 kV; 8 kV; 15 kV in the air 8 kV in contact 15 kV in the air 2 kV for power lines 2 kV for power lines 1 kV for signal ports Shockwaves 1 kV in Differential mode 1 kV in Differential mode
(IEC61000-4-5) 2 kV in common mode 2 kV in common mode Magnetic field at assigned industrial frequency
(IEC61000-4-8) Voltage dips, brief interruptions and voltage variations
(IEC61000-4-11) 30 A/m 30 A/m 0% UT pour 0.5 cycles 0% UT for 0.5 cycles At 0, 45, 90, 135, 180, 225, 270 et 315 A 0, 45, 90, 135, 180, 225, 270 and 315 Environment of a professional health care facility. Environment of a professional health care facility. Environment of a professional health care facility. Environment of a professional health care facility. Environment of a professional health care facility. Manual validation date: 26/10/2018 26 of 34 Smart Storage Refrigerator User Manual Version: 5.0 0% UT pour 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) Environment of a professional health care facility. Manual validation date: 26/10/2018 27 of 34 Smart Storage Refrigerator User Manual Version: 5.0 Electromagnetic immunity, radiofrequency:
The SST-R 3x2 is intended for use in the magnetic and electromagnetic environment described installer must ensure that the electromagnetic environment is compliant. in the table below. The user and the Immunity test Test level Level of compliance Electromagnetic environment / remarks WARNING: RF portable communication devices (including peripherals such as antenna cables and external antennas) should not be used closer than 30 cm (12 inches) to any part of the PRD_7130400B, including cables specified by the manufacturer. Otherwise, the performance of these devices may be altered. Radiofrequency electromagnetic fields radiated 3 V/m 3 V/m 80 MHz to 2.7 GHz 80 MHz to 2.7 GHz
(IEC61000-4-3) 80 % MA at 1 kHz 80 % MA at 1 kHz Environment of a professional health care facility. 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 Proximity Fields Transmitted by RF Wireless Communication Devices (IEC 61000-4-3 Method provisional) 27 V/m 385 MHz 28 V/m 27 V/m 385 MHz 28 V/m Environment of a professional health care facility. 450 MHz, 810 MHz, 450 MHz, 810 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 3 V 3 V 150KHz to 80MHz 150KHz to 80MHz 6 V in ISM band and 6 V in ISM band and band between band between 0.15 MHZ and 80 MHZ, 0.15 MHZ and 80 MHZ, 80% MA at 1 KHz 80% MA at 1 KHz Conducted disturbances, induced by fields RF (IEC610004-6) Environment of a professional health care facility. Manual validation date: 26/10/2018 28 of 34 Smart Storage Refrigerator User Manual Version: 5.0 4.4 Contraindications As a preventive measure, it is recommended that people fitted with pacemakers do not use the SST-R. 4.5 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. 5 Cleaning instructions This chapter outlines the process which must be followed 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. Manual validation date: 26/10/2018 29 of 34 Smart Storage Refrigerator User Manual Version: 5.0 Only staff members trained by the company are authorised to clean the SST-R. Staff members responsible for cleaning the SST-R must be familiar with how it works, its documentation and more specifically safety instructions. The cleaning procedure is as follows:
Switch the SST-R to maintenance mode Remove the bags before dismantling a drawer (move the bags into a different refrigerator) Verify the condition of the drawer during reassembly Do not assemble cracked, worn or dirty drawers. Use a spray product chemically compatible with the SST-R component materials which both cleans and disinfects. Rub with a soft cloth. Fig. 1. Spray the detergent disinfectant onto the area to be cleaned or onto a non-woven wipe. Fig. 2. Spread the product evenly To clean the SST-R and maintain it in good working condition, we recommend following the instructions below. Before cleaning the SST-R, always switch it to maintenance mode (see HMI manual). Risk of damage caused by unsuitable cleaning tools such as high-pressure washers, pressurised water or water jets. Do not 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 Manual validation date: 26/10/2018 30 of 34 Smart Storage Refrigerator User Manual Version: 5.0
- Abrasive compounds or scourers (scouring powder, steel wool)
- Polishing products, waxes, bleaching agents Always follow the cleaning product manufacturers instructions regarding temperature, dosage, acting time, etc. After completing all cleaning operations, check that the device is operational. Manual validation date: 26/10/2018 31 of 34 Smart Storage Refrigerator User Manual Version: 5.0 6 First-level maintenance. This chapter outlines the first-level faults* you may encounter when using the SST-R. Red indicator on the drawer fronts RBC 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 Actions required 1 Move the bag to a functional space, 2 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.
* In case of fault, the RFID traceability can be interrupted. This interruption is referenced in the product event log. When a red LED appears, try to detect the cause of the fault and eliminate it as quickly as possible. Red drawer space LED Possible causes Data cannot be written The drawer has been open for more than 4 minutes Communication with processor lost Move the bag to another space and try again Action Close the drawer Inform the member of staff in charge of maintenance so that corrective maintenance can be carried out. Manual validation date: 26/10/2018 32 of 34 Smart Storage Refrigerator User Manual Version: 5.0 7 Warranty Failure to observe any of the recommendations will void the warranty. 8 Transport When receiving the SST-R, 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 manufacturers installation recommendations. Work or repairs carried out by persons who have not been authorised by the manufacturer. Using the device as part of an electrical installation that does not comply with 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 Because the medical device is an item of electric and electronic equipment, it must be disposed of via a specific waste collection, removal, recycling or destruction process. The machine must be recycled in accordance with applicable national requirements. Manual validation date: 26/10/2018 33 of 34 Smart Storage Refrigerator User Manual Version: 5.0 European Union legislation requires that member states collect and dispose of electrical and electronic equipment separately from other unsorted municipal waste. The product, including accessories, cells and batteries, must not be disposed of as recyclable waste. Cells and batteries must be removed before the machine is disposed of or scrapped, and must be deposited in specially provided local collection boxes. 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 52: 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-Ids instructions Manual validation date: 26/10/2018 34 of 34
frequency | equipment class | purpose | ||
---|---|---|---|---|
1 | 2019-03-06 | 13.56 ~ 13.56 | DXX - Part 15 Low Power Communication Device Transmitter | Original Equipment |
app s | Applicant Information | |||||
---|---|---|---|---|---|---|
1 | Effective |
2019-03-06
|
||||
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 27300
|
|||||
1 |
France
|
|||||
app s | TCB Information | |||||
1 | TCB Application Email Address |
t******@us.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 |
SSTR-V2
|
||||
app s | Person at the applicant's address to receive grant or for contact | |||||
1 | Name |
P****** P********
|
||||
1 | Telephone Number |
02 32********
|
||||
1 | Fax Number |
02324********
|
||||
1 |
c******@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?: | No | ||||
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 SST-R | ||||
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
|
||||
1 | Name |
P**** P********
|
||||
1 | Telephone Number |
00-33********
|
||||
1 | Fax Number |
00-33********
|
||||
1 |
p******@lcie.fr
|
|||||
Equipment Specifications | |||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
1 | 1 | 15C | 20 | 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