Smart Storage Agitator for PC4200 User Manual Version: 2.2 USER MANUAL Smart Storage Agitator for PC4200 SST-A for PC4200 Headquarters : 1, rue du Commandant Robert Malrait ZA des Granges BP 30303 27303 Bernay cedex France Tél. : +33(0)2 32 47 83 40 Fax : +33(0)2 32 47 83 50 Web : www.biolog-id.
Smart Storage Agitator for PC4200 User Manual 1. 2. General information to the user ..................................................................................................... 4 1.1. Function of the Manual ........................................................................................................... 4 1.2. Manual Recipient..................................................................................................................... 4 1.3. Manual Plan.....................
Smart Storage Agitator for PC4200 User Manual 4.6. Version: 2.2 Warning to users in the CANADA/ Attention pour les utilisateurs au CANADA ................... 26 5. Cleaning Instructions ..................................................................................................................... 27 6. First Level Maintenance ................................................................................................................ 29 7. Warranty..........................................
Smart Storage Agitator for PC4200 User Manual Version: 2.2 1. General information to the user 1.1. Function of the Manual The user manual must be read thoroughly and carefully before using. This user manual informs you in a clear and detailed manner on how to use the SST-A for PC4200 and to carry out maintenance correctly and safely. The illustrations and photos in this manual are representative of the SST-A for PC4200. This also applies to all actions, remarks and explanations contained in this manual.
Smart Storage Agitator for PC4200 User Manual Version: 2.2 1.5. Additional Documents to this Manual In parallel with this user manual the below is provided: Installation and maintenance instructions. Note that the installation of the SST-A for PC4200 must be performed by a trained and authorized person by Biolog-id. A manual for using the GUI (Graphical User Interface). All these manuals are available only in paper format. 2. Presentation of the Smart Storage Agitator for PC4200 (SST-A for PC4200) 2.
Smart Storage Agitator for PC4200 User Manual Version: 2.2 The SST-A for PC4200 can also exchange and write data by communicating with a third-party software. The latter can then display the data relating to a bag (expiry date, movements). 2.2. Environmental characteristics of the Use of SST-A for PC4200 The SST-A for PC4200 is designed for usage in hospitals. The SST-A is used in a platelets agitator Helmer PC4200 of blood bank specifically qualified to function with the medical device. Fig.
Smart Storage Agitator for PC4200 User Manual Version: 2.
Smart Storage Agitator for PC4200 User Manual Version: 2.2 2.3. Description of SST-A for PC4200 This chapter details the different components of the SST-A for PC4200 as well as their function. Fig. SST-A for PC4200 set 2.3.1. Calculator and Power Fig. Calculator and its Power supply set The calculator in the SST-A for PC4200 system is responsible for managing data, queries and transferring information to higher-level applications (third-party software for example).
Smart Storage Agitator for PC4200 User Manual Version: 2.2 2.3.2. Drawer Fig. Drawer The drawer is the component for storing the PC bags. 2.3.3. Satellite Fig. Satellite An RFID satellite placed between two drawers allows the localization of PC bags. The satellite is a subset consisting of RFID antennas for communication with the RFID tag of the PC bag.
Smart Storage Agitator for PC4200 User Manual Version: 2.2 The operating principle of the RFID system is based on a transponder (RFID tags) and an interrogator (coupler). The latter is an active radiofrequency transmitter device that will activate the RFID tags located in the slot by providing them with the energy they need to operate. In addition to the energy, the interrogator sends particular commands to which the RFID tag responds.
Smart Storage Agitator for PC4200 User Manual Version: 2.2 Fig. Lower shielding The shielding prevents the satellites of each SST-A kit from detecting tags located in other kits of the full SST-A for PC4200 set (more information below) Fig.
Smart Storage Agitator for PC4200 User Manual Version: 2.2 2.4. Hardware and software compatibility 2.4.1. Agitator The SST-A is compatible with the Helmer PC4200 agitator. 2.4.2. Climate chamber The SST-A for PC4200 is compatible with all environmental chambers used for the storage of the PC bags if the platelets agitator is not an incubator. 2.4.3. RFID tag. Fig Platelet concentrate bag and RFID tag The RFID tag is used to store product and patient data as well as PC bag traceability data.
Smart Storage Agitator for PC4200 User Manual Version: 2.2 In red: area of non-detection of the tag The RFID tags compatible with the SST-A for PC4200 are passive tags. 2.4.4. Third party software. The SST-A for PC4200 can subscribe a third-party software and communicate via its web service to share / exchange PC traceability data (standard communication protocol). The third-party software can then request the SST-A for PC4200 to write data to the RFID tag memory.
Smart Storage Agitator for PC4200 User Manual Version: 2.2 3. Using Smart Storage Agitator for PC4200 (SST-A for PC4200) This chapter aims to present the SST-A for PC4200 operation. 3.1. Implementation of PC bags in SST-A for PC4200: 1 - Open a drawer 2 – Positioning of the PC bag in the drawer Note: In diagnostic mode (verification of the operation of RFID and LEDs) the front of the satellite flashes. PC bags can be placed in any direction: in the width or length of the drawer.
Smart Storage Agitator for PC4200 User Manual Version: 2.2 Red LED on: The calculator is in non-functional mode (out of order) or there is a disconnection to the network. Refer to "Chapter 6 - Level 1 Maintenance" of this manual Green and red LEDs on: Network disconnection. Refer to "Chapter 6 - Level 1 Maintenance" of this manual Green LED on only: The battery is no longer charging and potentially discharged. Check that the power cord is securely connected.
Smart Storage Agitator for PC4200 User Manual Version: 2.2 Within the same SST-A kit of the 4 SST-A kits included in the full set; In the event of a write failure on an RFID chip, an error message is returned to the request-initiated third-party system and the LED of one or two satellites lights up in orange.
Smart Storage Agitator for PC4200 User Manual Version: 2.
Smart Storage Agitator for PC4200 User Manual Version: 2.2 4. Safety instructions This chapter details the safety precautions to be applied when using the SST-A for PC4200. Please read these instructions carefully 4.1. General safety • Have all installation work and adjustments performed by qualified personnel only. Operations performed by persons lacking competence in this area may adversely affect the performance of the device and cause damage to property and body.
Smart Storage Agitator for PC4200 User Manual Version: 2.2 • The SST-A for PC4200 must only be used with the original accessories or original spare parts as these are the only accessories / spare parts whose reliability, safety and compatibility with our medical device have been checked. • In all circumstances, follow the instructions of the safety signs affixed to the SST-A for PC4200.
Smart Storage Agitator for PC4200 User Manual Mechanical Version: 2.2 Check the fasteners regularly. Ensure that only operators trained and familiar with security measures use SST-A for PC4200. Draw the drawers only by the handle provided for this purpose. 4.2. Hazards of RF radiation The SST-A electronic system antennas each emit a frequency of 13.56 MHz with a maximum power output of -6,40dBµA/m at 3m (less than the 42dBµA/m limit threshold).
Smart Storage Agitator for PC4200 User Manual Version: 2.2 Certain types of mobile telecommunication devices such as mobile phones are likely to interfere with the SST-A. The separation distances recommended in this chapter must therefore be complied with. The SST-A should not be used in the vicinity or placed on top of another device. If this cannot be avoided, its effective operation must be checked under operational conditions before use.
Smart Storage Agitator for PC4200 User Manual Version: 2.2 Recommended separation distances The SST-A 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 Agitator for PC4200 User Manual Version: 2.2 Magnetic and electromagnetic immunity The SST-A is intended to be used in the magnetic and electromagnetic environment described in the table below. The user and the installer must guarantee the compliance of the electromagnetic environment. Immunity test Test level according to IEC60601 Compliance level Electromagnetic environment/comments ± 8 kV contact discharge ± 8 kV contact discharge Professional healthcare facility environment.
Smart Storage Agitator for PC4200 User Manual Version: 2.2 Electromagnetic immunity, radio frequencies: The SST-A is intended to be used in the magnetic and electromagnetic environment described in the table below. The user and the installer must guarantee the compliance of the electromagnetic environment.
Smart Storage Agitator for PC4200 User Manual band ranging from band ranging from 0.15 MHZ to 80 MHZ, 0.15 MHZ to 80 MHZ, 80% MA at 1 KHz 80% MA at 1 KHz Version: 2.2 4.4. Cons-indications As a prevention, it is advisable for people with a pacemaker not to use the SST-A for PC4200. 4.5. Warning for United States users Federal Communication Commission Interference Statement 47 CFR Section 15.
Smart Storage Agitator for PC4200 User Manual Version: 2.2 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).
Smart Storage Agitator for PC4200 User Manual Version: 2.2 Conformément à la réglementation d’Industrie Canada, le présent émetteur radio peut fonctionner avec une antenne d’un type et d’un gain maximal (ou inférieur) approuvé pour l’émetteur par Industrie Canada. Dans le but de réduire les risques de brouillage radioélectrique à l’ intention d’autres utilisateurs, il faut choisir le type d’antenne et son gain de sorte que la puissance isotrope rayonnée équivalente (p.i.r.e.
Smart Storage Agitator for PC4200 User Manual Version: 2.2 Fig.2. Distribute the product To clean and maintain the proper functioning of the SST-A for PC4200, we advise you to follow the instructions below. Before each cleaning, make sure to put the SST-A for PC4200 in maintenance mode (see GUI manual). Risks of material damage caused by the use of unsuitable cleaning utensils, high-pressure cleaner or water spray or under pressure.
Smart Storage Agitator for PC4200 User Manual Version: 2.2 6. First Level Maintenance This chapter describes the first-level failures, which you can meet when using the SST-A for PC4200. Actions to be taken Appearance of a red indicator on the facades of satellites There is potentially no traceability at the location where the indicator is red 1 Move the bags to a functional location 2 Notify maintenance reference personnel for corrective maintenance intervention.
Smart Storage Agitator for PC4200 User Manual Version: 2.2 When a red LED appears, try to detect the cause of the fault and eliminate it as soon as possible.
Smart Storage Agitator for PC4200 User Manual Version: 2.2 8. Transport Upon receipt of the SST-A for PC4200, check that it has not been damaged during transport. If you notice any transport damage, immediately contact the carrier or your dealer with the delivery note or the purchase order. Packaging example: RFID Card pack SST-A for PC4200 kit Calculator pack 9.
Smart Storage Agitator for PC4200 User Manual 11. Version: 2.2 Disposal and recycling As electrical and electronic equipment, the disposal of the medical device must be carried out according to a specialized system of collection, removal, and recycling or destruction. The recycling of the machine must comply with national regulations. The legislation of the European Union member states prescribed to collect electrical and electronic equipment separately from unsorted municipal waste.
Smart Storage Agitator for PC4200 User Manual 13. Version: 2.
