SMART STORAGE FREEZER SST-F USER MANUAL 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 Web: www.biolog-id.
Smart Storage Freezer user manual Version Contents 1 2 General user information. ............................................................................................................... 4 1.1 Purpose of the manual. ........................................................................................................... 4 1.2 Intended audience................................................................................................................... 4 1.3 Structure of the manual. ...
Smart Storage Freezer user manual Version 6 First-level maintenance. ................................................................................................................ 31 7 Warranty........................................................................................................................................ 32 8 Transport .......................................................................................................................................
Smart Storage Freezer user manual Version 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-F and how to maintain it properly and safely. The illustrations and images contained in this manual represent all the SST-F models. This also applies to all the actions, comments and explanations contained in this manual.
Smart Storage Freezer user manual Version 1.5 Documents supplementing this manual The following is provided along with this user manual: - Installation and maintenance manual. Note that the SST-F 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 Freezer (SST-F). 2.1 Claimed use of the SST-F.
Smart Storage Freezer user manual Version 2.2 Required environmental characteristics for SST-F operation. The SST-F is designed to be used in a hospital environment by laboratory technicians who have been specifically trained to handle FFP bags. The SST-F is used inside a blood bank freezer/cold room that has been specifically qualified to work with this medical device. (See Chapter 2.4, Hardware and software compatibility). Fig.
Smart Storage Freezer user manual Operating temperature Version -40°C to 40°C (Power supply: -25°C to +40°C) SST-F 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 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%
Smart Storage Freezer user manual 2.3 Description of the SST-F. This chapter describes the component parts of the SST-F kit and their function. Figure 3 SST-F kit Figure 4 SST-F satellite drawer assembly Manual validation date: 18/07/2019 8 of 33 Version 4.
Smart Storage Freezer user manual Version Recommendation: For optimal location, the tag must be centred on the bag. Tag positioning area FFP bag Figure 5 Tag positioning 2.3.1 Processor and power supply. Figure 6 Processor and power supply The processor in the SST-F 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. Manual validation date: 18/07/2019 9 of 33 4.
Smart Storage Freezer user manual Version 2.3.2 Wiring harness. Figure 7 wiring harness A wiring harness supplies power to every drawer and carries data between the processor and the RFID antennas. 2.3.3 Drawer. Figure 8 drawer unit The drawer is a module used to store FFP (fresh frozen plasma) bags. There is only one range of drawers and it provides 10 spaces: • • 2 rows of 4 small spaces 1 row of 2 large spaces Manual validation date: 18/07/2019 10 of 33 4.
Smart Storage Freezer user manual Version Up to 3 standard FFP bags from a “contact shock freezer” or 2 bags from a normal freezer can be stacked on top of each other in small spaces. Up to 3 standard FFP bags from a “contact shock freezer” or 2 apheresis bags from a “contact shock freezer” or 2 bags from a normal freezer can be stacked on top of each other or staggered in large spaces. Recommendation: Any bag entering the SST-F must be frozen to ensure the effective functioning of the equipment. 2.3.
Smart Storage Freezer user manual Version 2.3.5 Temperature probe. The temperature probe integrated into the SST-F is waterproof. It measures the temperature of an area. Figure 10 temperature probe The only reference temperature is that provided by the controlled climate chamber. The SST-F makes no claims as to temperature-related performance. The SST-F temperature reading is for information only. This function is unrelated to cold chain maintenance security. 2.
Smart Storage Freezer user manual Version 2.4.3 RFID tag. Figure 11 RFID tag and Fresh Frozen Plasma bag The RFID tag stores product and patient data as well as FFP bag tracking data. Only passive RFID tags referenced by Biolog-id are compatible with the SST-F. For further details, please contact the quality department at: Qualite@biolog-id.com 2.4.4 Third-party software.
Smart Storage Freezer user manual 3 Using the Smart Storage Freezer (SST-F). The purpose of this chapter is to show how the SST-F works. 3.1 Placing FFP bags in the SST-F and satellite indicator lights 3.1.1 Installation of FFP bags 1 - Open a drawer 2 - Place the FFP bag in a free space or one with enough room to stack another FFP bag. Pay special attention to the tube if the FFP bag is unboxed* *For better user visibility, we recommend placing the bag label on top.
Smart Storage Freezer user manual Version 3.1.2 Light indicators of the satellite Please note: In diagnostic mode (RFID and LED operation verification), the front of the drawer flashes Red indicator on the drawer fronts: Figure 12 Red LED on SST-F A technical failure has been identified on the RFID. FFP bag tracking may no longer be possible in the drawer showing a red indicator.
Smart Storage Freezer user manual Version 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, the meanings of which 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.
Smart Storage Freezer user manual Version 4.0 4 Safety instructions. This chapter provides a detailed description of the safety instructions applicable when using the SST-F. Please read these instructions carefully 4.1 General safety instructions.
Smart Storage Freezer user manual Electrical Mechanical Version 4.0 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. Before connecting and commissioning the machine, check that the power supply is connected correctly.
Smart Storage Freezer user manual Version 4.2 RF radiation hazards. The SST-F electronic system antennas each emit a frequency of 13.56 MHz with a maximum power output of -2.38dBµA/m at 3m (less than the 42dBµA/m limit threshold). MEDICAL ELECTRICAL DEVICES require special EMC precautions. The SSTF must be installed and commissioned in accordance with the EMC data supplied in the ACCOMPANYING DOCUMENTS.
Smart Storage Freezer user manual Version All information featured below comes from normative requirements which apply to the manufacturers of medical electrical devices, under standard IEC60601-1-2 Ed3. Directives and manufacturer declaration - electromagnetic emissions The PRD-7140100A is designed to be used in the electromagnetic environment specified below. PRD-7140100A customers or users must ensure that their devices are used in such an environment.
Smart Storage Freezer user manual Version Directives and manufacturer declaration - electromagnetic immunity The PRD-7140100A is designed to be used in the electromagnetic environment specified below. PRD-7140100A customers or users must ensure that their devices are used in such an environment.
Smart Storage Freezer user manual Version Directives and manufacturer declaration - electromagnetic immunity The PRD-7140100A is designed to be used in the electromagnetic environment specified below. PRD-7140100A 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 NOTE 1 At 80 MHz and at 800 MHz, the highest range of frequencies is applicable.
Smart Storage Freezer user manual Version Directives and manufacturer declaration - electromagnetic immunity The PRD-7140100A is designed to be used in the electromagnetic environment specified below. PRD-7140100A customers or users must ensure that their devices are used in such an environment.
Smart Storage Freezer user manual Version The tables below relate to the SST-F (PRD_7140300A). All information featured below comes from normative requirements which apply to the manufacturers of medical electrical devices, under standard IEC60601-1-2 Ed4.
Smart Storage Freezer user manual Version Recommended separation distances The SST-F 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.
Smart Storage Freezer user manual Immunity test Version Test level according to IEC60601 Compliance level Electromagnetic environment/comments ± 8 kV contact discharge ± 8 kV contact discharge Professional healthcare facility environment. ± 2 kV; ± 4 kV; ± 8 kV; ± 15 kV air discharge ± 2 kV for power supply lines ± 15 kV air discharge ± 2 kV for power supply lines ± 1 kV for signal ports Professional healthcare facility environment.
Smart Storage Freezer user manual Immunity test Test level Compliance level Version 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_7140300A, including cables specified by the manufacturer. Otherwise the performance of these devices could be adversely affected. Radiated electromagnetic fields RF 3 V/m 3 V/m 80 MHz to 2.
Smart Storage Freezer user manual Version 4.4 Contraindications As a preventive measure, it is recommended that people fitted with pacemakers do not use the SST-F. 4.5 Warning for US 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.
Smart Storage Freezer user manual Version 5 Cleaning instructions This chapter sets out the SST-F cleaning procedure to follow. The device must be cleaned or disinfected before use. The SST-F 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-F.
Smart Storage Freezer user manual Version Figure 16 Spread the product evenly To clean the SST-F and maintain it in good working condition, we advise following the instructions below. Before cleaning the SST-F, 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.
Smart Storage Freezer user manual Version 6 First-level maintenance. This chapter outlines the first-level faults* you may encounter when using the SST-F. Actions required 1 Move the bag to a drawer that works, Red indicator on the drawer fronts 2 FFP bag tracking may no longer be possible in the drawer showing a red indicator Inform the member of staff in charge of maintenance so that corrective maintenance can be carried out.
Smart Storage Freezer user manual Version 4.0 When a red LED appears, try to detect the cause of the fault and eliminate it as quickly as possible. Red LED on drawers Possible causes Actions Data cannot be written Move the bag to a different space and try again The drawer has been open for more than 4 Close the drawer minutes Inform the member of staff in charge of Communication with processor lost maintenance so that corrective maintenance can be carried out.
Smart Storage Freezer user manual Version 4.0 10 Service life The service life of the device under recommended usage and maintenance conditions is 10 years. 11 Disposal and recycling As the medical device is a piece of electrical 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 applicable national requirements.
