ENG - DIESSE Diagnostica Senese
Contents
1. One power cable for each module according to IEC International Standard Female Plug IEC 320 C 13 Male Plug Schuko EEC 7 VII Rating 10A 250Vac USB cable Handles to lift the ROBOBACT module by hand Two spare delayed fuses T 5A 250V Software installation CD Robobact Manager Document with the HARDWARE PARAMETERS of the module Packing list Positioning The intended working environment for this instrument is an analysis laboratory For normal safety requirements and given the type of examination it performs the instrument must be positioned away from heat sources in areas unreachable by liquids and in a dustfree environment If the specific support trolley is not used position the instrument on a solid perfectly level bench not subject to shaking or vibrations In order to allow immediately acting on the power switch and the power cable in the event of danger leave sufficient space between the laboratory walls or other instruments and ROBOBACT Do not place any object on the instrument In addition it is advisable to position the instrument away from devices that generate electromagnetic waves e g laboratory fridges centrifuges and instruments that do not have the CE marking as they might compromise proper functioning Obligations of the customer The safety of the instrument and of the operator is not guaranteed if one or more of the following conditions are violated The mains must be compatible with2. Sample tray Thermostating unit Unit for identification of the type of examination and its status Mixing unit ROBOBACT USER MANUAL TECHNICAL DATA Instrument composition Technical features External connections and unit of measure Technical description of the Robobact module The ROBOBACT module consists of a single body containing all the operating functions necessary for bacteriological isolation The samples are introduced through the window on the front The power supply and serial USB ports for connection to the computer are positioned on the rear Below follows a description of the functional units of the module The sample tray consists of a round rotary crown divided into seven sections each of which contains the housings for five samples for a total of 35 positions The operating temperature is preset for each method During operation it is measured and compared with the programmed temperature and if there are any variations 0 5 C heating by means of a heating element with fan positioned in the centre of the instrument is activated deactivated When the instrument is not running a cycle a standby temperature of 18 C 0 5 C is maintained This unit consists of a barcode reader which by reading the barcode on the exterior surface of the device identifies the type of sample under examination thus associating it with the enrichment breaking seeding and incubation times and procedures programmed fo
3. nICOCE ROBOBACT Module for growth and isolation of bacteria and yeast from biological samples Diagnostic Device EC IVDD 98 79 USER MANUAL Robobact Manager for MS Windows XP Vista 7 operating systems MIECCE This manual is applicable to the following ROBOBACT instrument models ROBOBACT ROBOBACT SPECIAL LIST OF MANUAL REVISIONS VERSION DATE APPROVED MODIFICATIONS Robobact Manager rel 1 1 0 2 02 03 2009 New software for MS Windows XP Vista 7 operating systems 2 00 Robobact Manager rel 1 4 4 x 20 01 2010 New software for Robobact Special Modules 94210 USB 2 01 USB Robobact Manager rel 1 4 4 x 23 07 2010 Some of the Technical Features have been changed New Technical Support contact Robobact Special declaration of Conformity has been added Standards applied to this document UNI EN 591 Il Edition November 2001 CEI EN 61010 1 Il Edition Dossier 6290 November 2001 The information contained in this manual may be subject to modifications without prior notice No page in this manual may be reproduced in any form or by any means electronic mechanical or otherwise for any use whatsoever without prior written permission from DIESSE DIAGNOSTICA SENESE S p A 2 36 Robobact DIESSE DIAGNOSTICA SENESE S p A Via delle Rose 10 53035 Monteriggioni Siena Italy Tel 0577 58 71 11 Fax 0577 31 86 90 www diesse it LEGAL REPRESENTATIVE MANAGING DIRECTOR REGISTERED AND ADMINISTR
4. Test not found Temp incompatible 02 incompatible Normally it does NOT lock module activity The samples present in the other positions are processed normally When one of these errors occur refer to the table below for the analysis of the problem and the procedure to follow to correct it Description Problems in reading the barcode of the device Error in reading the barcode of the device Error during sample seeding The device ball was not detected during identification The barcode of the device is not in the Methods list There are two methods with different incubation temperatures There are two methods with different atmosphere control Procedure If after starting the cycle and during the device identification phase the barcode is not read label damaged etc the instrument will at the end of the identification phase automatically run a new scan on all 35 samples rereading the label in a slightly different position If code reading fails again the Barcode error is displayed The instrument was unable to read the device label The sample is not processed Stop the cycle put the sample on a new device and restart If the problem occurs frequently even when the labels are in a good condition it may be a problem with the internal barcode reader Notify the Authorised Technical Service The sensor does not see the device ball at the moment of seeding Check whether or not seeding has taken p
5. or clear the bench where the instrument is to be positioned Take the box containing the computer and find a space on the module or on the bench for optimal positioning Screw the handles onto the cover of the ROBOBACT module Place the ROBOBACT module on the trolley or on the bench Remove and put the handles inside the trolley accessible from the rear Fit the 4 bolts to secure the cover Release the trolley wheels and position it in the chosen position Lock the wheels Tie the strips of expanded polyethylene together with some tape Fold the central part of the wooden crate by pushing on it and keep everything together with the cover bottom and handles for possible future moving of the instrument 5 Connect the computer and the ROBOBACT module to the mains two separate power supplies 6 Connect the USB cable between the ROBOBACT module and the computer see Fig 2 1 in Chapter 2 7 Turn on the instrument see Chapter 4 Rev 2 01 USB 17 36 DISCONNECT the instrument from the mains before any technical operation or in the event of malfunctioning of the instrument ROBOBACT USER MANUAL 8 For Robobact Special 94210 you also need to connect the external CO and N bottles using the tubes provided The bottles must be equipped with pressure reducers and pressure gauges The output pressure must be between 3 and 6 Atmospheres Bar The diameter of the male connector at the pressure gaug
6. See APPENDIX A EC Declaration of Conformity For more details consult the sales agreement stipulated with the distributor ROBOBACT USER MANUAL Manufacturers responsibility DIESSE DIAGNOSTICA SENESE S p A declines all responsibility for improper use of the instrument or failing to use the instrument as specifically indicated in this manual The manufacturer s responsibility is in any event limited exclusively to malfunctioning of the instrument and solely during its intended use Directive 1999 34 EC in amendment of European Directive 85 374 EEC implemented in Italy with Pres Decree 224 of 24 May Law Decree 25 of 02 02 2001 and only if the power cables provided with the instrument are used Carefully read this manual before use It is assumed that only qualified and skilled persons will operate the instrument Reference standards DIESSE DIAGNOSTICA SENESE S p A an ISO 13485 and ISO 9001 certified company declares to have followed the Directives in the design and construction of the ROBOBACT instrument in terms of safety as described in Appendix A to this manual DIESSE DIAGNOSTICA SENESE S p A subjects all its products to strict quality controls However should the instrument show signs of malfunctioning despite these controls please contact the authorised Technical Service Centre indicated to you at the time of delivery of the instrument Warranty DIESSE DIAGNOSTICA SENESE S p A guarantees the ROBOBACT
7. connected to the PC N Then insert the sample container in the device and insert this in the unoccupied position on the DIT sample tray positioned in front of the door DINI p yp P Codi Codice test a ae l The sample code is immediately shown on the 02 Dante Alighieri Unknown screen in the position on the tray where the device was inserted If you do not have an external barcode reader or if the code label is damaged you can enter the code by hand Press the Keyboard key type in the code and press Enter then insert the device in the instrument Rev 2 01 USB 30 36 SL ILS WARNING The cycle starts automatically after closing the door The urine samples have priority over the others and immediately go to the seeding phase ROBOBACT USER MANUAL ia WARNING DO NOT REMOVE OR MOVE THE DEVICE AFTER MATCHING IT WITH ITS POSITION Continue as above with insertion of other devices in the accessible housings Move on to the next 5 positions by pressing the key of the next section e g Sect 6 10 or any other section until there are no more unoccupied housings WARNING Each time you move by one section the tray is moving Wait for it to stop before inserting the samples DO NOT MOVE THE TRAY BY HAND Continue with insertion until all the samples to be examined have been inserted or when reaching the maximum capacity of the instrument 35 samples Then close the door
8. directives and their amendments Low Voltage Directive 2006 95 EEC Electromagnetic Compatibility Directive 8N 336 EEC 93 68 EEC and 2004 108 EEC Place date of issue Monteriggioni 1 April 2009 Signature Francesco Cocola General Manager This is the certified copy of the original document stored in archive of DIESSE Diagnostica Senese SpA r Issued Monteriggioni 23 July 2010 f Moe Gabriele Monciatti R A Manager Rev 2 01 USB 35 36 ROBOBACT USER MANUAL EC DECLARATION OF CONFORMITY In accordance with 98 79 EEC regulation regarding In Vitro Medical Diagnostics Devices RIES CE DIESSE Diagnostica Senese S p A DESSE DIAGNOSTICA SENESE S p A with head office in Milan Via A Solari 19 sc 6 certifies that the design type of manufacture of the in vitro medical diagnostics device described hereafter and the version distributed on the market conforms to the 98 79 EEC directive relevant to the In Vitro Medical Diagnostics Devices IVD through the accomplishment to the Annex Ill exceptsection 6 and the essential requirements of Annex l This certificate will lose its validity in the event of modifications made to the machine in question without our authorization incorrect use of the instrument technical interventions performed by unauthorized personnel installation of non original spare parts Product Automatic bacteria streaking and incubation unit Type ROBOBACT SPECIAL Technical da
9. its use any other part or accessory used in the instrument may cause damage or incorrect results The manufacturer therefore declines all responsibility for damages deriving therefrom Particular warnings Even though the Robobact system guarantees a good level of safety in handling biological samples faeces urine or swabs remember that you are still handling potentially infected material Therefore take all the necessary precautions according to the law Also the waste material at the end of the cycle must be processed like any other hospital waste SANITIZATION PROCEDURE The purpose of this protocol is to provide the technical laboratory operator with a procedure for cleaning and decontaminating the entire ROBOBACT instrument to ensure hygiene and reduce risks Whatever the disinfectant or biocide used apply the correct dosage for the minimum required contact time In this connection the instruments and the equipment must be cleaned before the disinfection operation This operation eliminates the biofilm and thus exposes the microorganisms to the action of the disinfectant It is therefore good practice to always keep the accessory instruments and equipment clean MATERIALS The product indicated in this protocol is UMONIUM 38 and acts as disinfectant and detergent Among the applications indicated is also cold disinfection of thermosensitive instruments and medical devices UMONIUM38 SPRAY ready to use solution that acts on a wi
10. of oxygen During a cycle with samples that require a modified atmosphere the controls on the injection of the necessary gases are activated In addition proper functioning of the electrovalves that allow NITROGEN N2 and CARBON DIOXIDE CO to flow into the instrument is indicated as follows CO not available Bottle empty N2 notavailable Bottle empty or generator empty Sa if In this case an acoustic alarm is also activated You can silence the alarm by pressing the Sound off key The cycle is not interrupted If you have a new bottle available you can replace it at this time without interrupting the cycle You can also replace the bottle later at any time without having to stop the cycle If the nitrogen generator is momentarily empty you can in any case decide to continue the cycle The generator will slowly be filled in 2 4 hours After connecting the new bottle the alarm disappears the red warning light goes off and the acoustic alarm stops If you do not have a reserve bottle you can in any case silence the alarm by pressing the Sound off key and continue with analysis of the cycle keeping an eye on the indication of the Oxygen reached WARNING In the event of a power failure or if the ROBOBACT SPECIAL door stays closed es and locked you can use the emergency wrench to OPEN the door and retrieve the samples following the procedure below Emergency door opening procedure Loosen the two black bushings that secure th
11. or insert new samples Insertion using the AUTOMATIC METHOD This method is used when you want to insert the samples by matching the barcode of the sample and its position in the tray If the instrument is in Ready state open the door following the sequence shown in the figure Ready Press the Sector key at the top right of the Main menu the key is activated only when the door is opened A new menu called Sample Insertion similar to the one described above will open where the section keys appear in the first column on the right Selecting a section you can move the 5 positions indicated on the key to in front of the door Sett 1 5 Sett 6 10 Sett 11 15 Sett 16 20 Sett 21 25 Sett 26 30 Sett 31 35 MES X Al 2 Atta OOO AE AE Ale 6 Alt 7 For example pressing the Sect 1 5 key the instrument positions with the first 5 housings of the Sett 1 5 a sa a tray in front of the door While the tray is moving an acoustic alarm is sounded and it will be impossible to insert or remove samples as long as the tray is moving Wait for the tray to stop before continuing WARNING id Sa LE IT IS PROHIBITED TO REMOVE OR INSERT THE DEVICE WHEN THE TRAY IS MOVING When the tray stops the 5 positions in front of the door are shown on EE the display on a green background Sia Before inserting the sample container in the device read the barcode using a barcode reader
12. the value ii n ill bn bh will appear in the box selected then press the Vi a a SAVE Key a a anais Caution pressing the DELETE key the method Sa selected will be deleted a Pressing the RESTORE key all the method characteristics are reset to the default settings recommended by DIESSE Diagnostica Senese S p A All the changes made to the enrichment time incubation time etc will be lost Press the EXIT key to exit the Methods window and return to the Manager page When the EXIT key is pressed a second time the Robobact Manager software closes and you exit the Windows environment If there are any modules connected a warning window will ask you for confirmation Press OK to close the program if you close the program with some modules connected and running a cycle these will continue operating independently When the Robobact Manager software is restarted the status of the samples will be updated to the actual status in the modules only the time recording of the temperature trend and O2 in each module will be lost or press CANCEL to return to the main page of Robobact Manager Rev 2 01 USB 25 36 ROBOBACT USER MANUAL Touching the summary window of each instrument a management page for the relative module is opened showing all 35 positions of the instrument in detail Lavorati Firmware Pos _Samplecode Testcode Start Time Enrich ime pas Time tncub Time EndTime 01 Urine cul
13. 36 Sound off Service F4 i E ROBOBACT USER MANUAL the previous pages you can view the trend in the last 5 days of module operation As the hours go by a line is drawn for the Oxygen trend with the following characteristics Oxygen in cycle Pressure in cycle Unplugged Oxygen in idle Pressure inidle Not monitored The Sound off key disables the acoustic messages and alarms The Service key is exclusively used by Technical Service and requires a password Pressing the Manager key you return to display of the Manager menu with the information on all the modules connected The Start Cycle key starts the cycle The key is active green only when the door is closed To stop the cycle press the same key which will have turned orange with the words Stop Cycle If the instrument has already started a seeding operation for a sample you have to wait for it to be completed see Sample insertion An acoustic signal will tell you that the door has been released and can be opened Rev 2 01 USB 28 36 When the instrument is running a cycle the door is locked To open it stop the cycle ROBOBACT USER MANUAL Sample insertion For sample preparation read the technical instructions that come with the package WARNING The samples contain potentially infected material You can choose from two sample insertion methods MANUAL METHOD the sample
14. ATIVE OFFICE Via A Solari 19 20144 MILANO Italy Tel 39 02 4859121 Fax 39 02 48008530 DIESSE ASSISTANCE CUSTOMER CARE Via delle Rose 10 53035 Monteriggioni SI Italy Tel 39 0577 587154 39 0577 587121 Fax 39 0577 587151 e mail technicalsupport diesse it 3 36 THE ROBOBACT SYSTEM INMICROBIOLOGY330xicuiritananrna TANTRA TIA RTRT TA RTI 6 pesci paon Ory ten COMDONENTS druain A a 6 Manufacturer STreSpOnSiDII Y eanne a cassoasianan Ssaianectasmotnesous 8 Reference standard rl 8 NON GUCE asset anata cin E RA E IERI RO RO 8 Warranty CONditl0Ns isa allinea 8 Materials reduired for use ofthe Instrument hellas 9 Parichat warnine Sienne E S S E cana aseneasaeaccunisahcceceseeamas eee 9 SANITIZATIONPROCEDURE ariana 9 TECHNICALDATA Gein 11 INSTRUMENT COMPOSITION TECHNICAL FEATURES EXTERNAL CONNECTIONS AND UNIT OF MEASURE seccccsceccscscsccsceccscncees 11 Technical description of the Robobact Module 11 Description ofthe Computer Unitaria eli 12 External instrumentconnecions acacia 13 FOCANICINTE ATUTO scacco 14 ROBOBACT and ROBOBACT Special modules csscccccssseccccesseccccensseesccsnseescssussecccsseecessussesecsuaeesessousescesseuseseesensesseseeess 14 TolleviscaRla nausea N E e E 14 Genecniectoea uc A A A 14 Unitor meda I esaa e a a 14 INSTALLATION calcia 15 PACKAGING HANDLING AND POSITIONING EQUIPMENT OBLIGATIONS OF THE CUSTOMER DISPOSAL cescscsccscsccscs
15. The display returns to the main page and the cycle is AUTOMATICALLY started Sample identification and processing Once the cycle has started the instrument begins the sample identification phase i Sr Pos Sample code Test code Start Time Enrich Time B amp S Time Incub Time End Time 01 Urine culture plus 04 June 08 43 04 June 08 43 1 05 June 14 30 In the main menu the position being analysed at that moment is shown on a green background and at the same if a device is present the description and the start date are shown When identification is complete sample processing begins with the following priorities e The urine samples have priority over the others and immediately go to the seeding phase e Next the instrument seeds the samples that do not require enrichment or those that have already been enriched e Finally it waits for the enrichment phase of the remaining samples to be completed and then processes these as well The cycle can be stopped at any time by pressing the Stop Cycle key Wait for the instrument to go into READY state before opening the door Remove the samples that have been completed or insert new samples and press Start Cycle again to restart analysis Rev 2 01 USB 31 36 ROBOBACT USER MANUAL Robobact Special Module 7 0 11 06 mbar The Robobact Special module allows you to modify the atmosphere in the instrument by injecting nitrogen and CO and to control the amount
16. Then the up down and forward backward movements are simultaneously activated for seeding on the agarized culture media by means of the calibrated loops positioned at the end of the fork After seeding the loops are firmly locked thus preventing dropping back to the bottom Finally the jaws are opened and the clamp moves away returning to the rest position Description of the Computer Unit Minimum requirements for the instrument CPU Intel Atom N270 1 6 GHz Dual Core Chipset Intel 945GSE ICH7 RAM 1 GB HDD 100 GB Audio ordinary Video Intel GMA950 ET1602 RadeonHD3450 ET1603 Display 15 6 in 16 9 format with resolution of 1366 x 768 pixels I O ports USB 2 0 one for each modules Connectivity Wireless 802 11 b g n Gigabit LAN 10 100 1000 Mbps optional Operating System Microsoft Windows XP vista 7 A barcode reader can be connected USB or keyboard emulation for insertion of the sample barcodes The code can directly be managed by the Robobact Manager software or alternatively the Robobact ID System can be used which independently manages the samples and communicates directly with the host computer for data transmission Rev 2 01USB 12 36 A USB cable ROBOBACT USER MANUAL External instrument connections The power supply 110 220 V and USB ports for connection to the Computer Manager are on the rear of the ROBOBACT module For the USB connection use the dedicated USB cable A Up to 24 ROBOBACT module
17. a Windows7 operating systems is installed The system is modular and can be equipped with the following components according to the laboratory s requirements e ROBOBACT Module ref 94200 This is the basic instrument and must be connected to a computer e ROBOBACT SPECIAL Module ref 94210 This module allows managing and controlling the amount of oxygen in the instrument It requires a nitrogen and CO distribution system It must be connected to a computer e TROLLEY Ref 94220 This is the trolley to support the PROCESSING UNIT and up to two ROBOBACT modules Equipped with four wheels and a spacious storage compartment it allows moving the instrument around and solves the space problem on laboratory benches e Generator TROLLEY Ref 94222 This is the trolley housing the NITROGEN generator a CO bottle support can be fitted on the outside CO Bottle Support ref 94200 for the ROBOBACT SPECIAL Module It makes the instrument fully stand alone even in laboratories that do not have a distribution system e COMPUTER UNIT ref VPPENT with integrated LCD touch screen display This is the computer that controls the ROBOBACT and ROBOBACT SPECIAL modules up to 12 modules Alternatively a computer with features similar to those indicated above may be used e Robobact Tray ref 94005 made of steel with 18 housings to facilitate device preparation transport and arrangement in the thermostat Rev 2 01USB 7 36
18. amage the internal parts Follow the instructions given in this chapter in order to guarantee the safety of the instrument and of the operator Transport and handling The instrument must be transported and handled in its original packaging which guarantees that it will withstand handling during loading onto trucks planes and ships It is important that the instrument be handled and transported with the top side up and not excessively tilted in order to prevent damaging it Given the dimensions and weight of the instrument it is recommended to use a lift truck for transport Do not let the instrument stand in the rain or in a damp environment even if packed If the instrument has been standing in a place at a temperature below 10 C for more than 24 hours it may only be installed after leaving it to stand at room temperature for one hour Packaging characteristics The instrument is packed in two identical foldable wooden crates 6mm thick birch plywood The crates are lined with strips of expanded polyethylene The product is packed follows Crate A ROBOBACT module Ref 94200 Crate B Trolley Ref 94220 The two crates have the following characteristics AB Width cm 78 78 Depth cm 65 65 Height cm 84 91 Weight of empty crate kg 25 25 Weight of packed crate kg 90 60 Rev 2 01 USB 15 36 I ROBOBACT USER MANUAL Matenals provided ROBOBACT is supplied with the following materials Instruction Manual
19. bols used in this document WARNING potential risk of CAUTION potential risk of damage to the personal injury all the conditions instrument all the conditions indicated in indicated in the relative text must the relative text must be read and be read and understood before understood before proceeding proceeding e N B Important information AA BIOHAZARD risk of Contamination with QV potentially infected substances Legend of electric and safety symbols used on the instrument Preliminary notes Caution risk of electric shock Read the manual observe _ the _ safety related symbols Before installation and use of the instrument it is advisable to carefully read the warnings and instructions contained in this user manual in order to ensure proper and safe use It is important that this user manual be kept together with the instrument for future reference In case of sale or transfer ensure that this manual accompanies the instrument to allow the new owner to be informed about its functioning and the relative warnings It is recommended to allow only qualified and skilled personnel to use the instrument Rev 2 01 USB 5 36 ROBOBACT USER MANUAL INTRODUCTION The Robobact system in microbiology he Robobact System is a fully automatic modern processor that allows seeding and bacterial development to achieve results comparable to the conventional method on plates with the advantage of not having to open th
20. cal Diagnostics Devices RIEC GE DESSE Diagnostica Senese S p A DIESSE DIAGNOSTICA SENESE S p A with head office in Milan Via A Solari 19 sc 6 certifies that the design type of manufacture of the in vitro medical diagnostics device described hereafter and the version distributed on the market conforms to the 98 79 EEC directive relevant to the In Vitro Medical Diagnostics Devices IVD through the accomplishment to the Annex Ill exceptsection 6 and the essential requirements of Annex l This certificate will lose its validity in the event of modifications mace to the machine in question without our authorization incorrect use of the instrument technical interventions performed by unauthorized personnel installation of non original spare parts Product Automatic bacteria streaking and incubation unit Type ROBOBACT Technical data 110 220 Vac 50 60 Hz Product Elaboration and control unit Technical data PROCESSING UNIT Type 110 220 Vac 50 60 Hz conforms as a whole and in its parts with the following standards and their amendments EN 61010 1 Safety requirements for electrical equipment for measurement control and laboratory use Part 1 General requirements EN 61326 1 Electrical Equipment for Measurement Control and Laboratory Use Electromagnetic compatibility requirements Part 1 General requirements And therefore meets the minimum requirements of the following Community
21. cecescces 15 WEF AMS OFC GING WAIN NIN tl ATE A IE A ETE EA ill E TE ila 15 Packaging character STIGS ahri cute saduccewu ci caules ndscsadyaeesmadlenanlvaesueticinss aa 15 Materiais Provide ean luana 16 POSIUONIN E erani a AA A Ea ene eemmeceuneneeat eae 16 Obligations OF the custome pasearen esnan Naa aE AE E TIEA NEENA EE aia A 16 Wis prohibited to usera enra in A EA TAEA E A E OA EAE 17 P S ta lel OO CC Ceci E iaia 17 Limitations and Warning Sanan a E dee tardeade dieses ence taredinnls ltd tants ested ec acl N 18 Operations to uninstall and reinstall the instrument in the same room or in a different place 18 Instrument compositioni DISPOSAL icc ssssoszyne tdensesaceeseustonehelheseuroed es taeeweueammaroaena see iaugs ene rt ere ues eae ene 19 USE ie a Lili leleine edi oil 20 INSTRUCTIONS FOR THE OPERATOR INSTRUMENT PROGRAMMING SAMPLE LOADING 0sceccsccscecceccccecceccsceccecesceccececcseeeees 20 TUNNE ON LAC INSTUMENlas atlanti 20 Descriptiofioftne LED INdICatio nascita 21 Description ofthe Robobact ManagermMend sccoalaliu cicala aaa 22 Insertion using the MANUAL METHOD i 29 Insertion Using the AUTOMATICMETHOD sselelolalraaiianah ea 30 Sample ICentitiCatlOnnane PLOCESSINS errena aE R E EA VANERNE EANET ENEE E NTE 31 Emergency door opening procedure 32 EF 33 APPENDIX A DECULARATIONS OFCONFORMITY uaar RITI 35 Rev 2 01 USB 4 36 SYMBOLS Legend of sym
22. de variety of bacteria mould and viruses UMONIUM38 solution to be diluted with water Manufactured by Huckert s International Chauss e de Namur 60 B 1400 Nivelles Belgium www huckerts net ALL THE OPERATIONS DESCRIBED BELOW MUST BE CARRIED OUT WEARING THE APPROPRIATE PERSONAL PROTECTION DEVICES protective gloves mask goggles Routine cleaning daily Rev 2 01USB 9 36 ROBOBACT USER MANUAL Turn on the Robobact instrument Spray some Umonium38 on the first section of the sample tray and wipe up to the 3rd 4th section with a paper towel Spray again on the next section and wipe onto the remaining sections and leave to dry Extraordinary cleaning In case of contamination considerable dirt or an accident for example biological sample spillage spray some product on each section of the tray and leave to dry If necessary in order to remove debris or dirt from each single housing in the tray unscrew the sections individually and immerse them in an 0 5 aqueous solution of Umonium38 Leave the sections immersed for 10 minutes then rinse with distilled water and leave to dry or dry with a paper towel Note The aqueous solution can be kept and reused within maximum 20 days however if it becomes murky or residues appear a fresh solution must be used Umonium38 is also used to clean and decontaminate the outside of the Robobact instrument including the LCD display which must be turned off Rev 2 01USB 10 36
23. e biological sample containers thus guaranteeing maximum safety for the operator and complete standardization of seeding The ease of use and the time saved together with a vast range of culture media available make this system unique of its kind _ Description of system components The Robobact System consists of containers to collect the samples devices containing culture media for seeding and an automatic instrument Containers for sample collection and transport differentiated by type of biological sample Faeces Coproset Urine Uriset Coproset Uriset Materials that can be swabbed Swabset Rev 2 01 USB 6 36 ROBOBACT USER MANUAL Seeding device containing A housing for the biological sample container Calibrated loops for seeding and colony isolation A housing for Par Test execution Automatic 35 position thermostated instrument that allows Identification of the sample by means of a barcode label Identification of the type of device culture medium Enrichment of the sample under mixing Breaking open the bottom of the sample container Simultaneous seeding on the two culture media of the device Monitoring the incubation temperature Coprobact Uribact Sending a report on the negative samples to the host computer upon indication of the operator The ROBOBACT instrument must be connected to a computer on which the ROBOBACT MANAGER control software for MS Windows XP Vist
24. e green plastic cover of the door and then open the green cover Insert the wrench in the centre of the door and remove the plastic cap by turning it anticlockwise Then again insert the wrench in the centre of the door and applying force turn Open it CLOCKWISE to open the door When the door is open screw the central cap back on by hand turning it clockwise Refit the green plastic cover by screwing on the two black bushings Rev 2 01 USB 32 36 Errors displayed in the function message window Error Type Tray error Ball error Door error Tray step error Clamp close error Clamp open error Horizontal motor error Vertical motor error w sa 3 p 4 5 15 37 28 Error list The error messages may regard a Robobact module in which case they are displayed in the Message Box function message window of the module ROBOBACT USER MANUAL he n or an individual sample being displayed in the status row of the __ processed in which case they are fina see position occupied by the sample BEI When the window is red the message points out a problem that locks normal functioning and stops the cycle When one of these errors occur try restarting the cycle false error otherwise if it reappears refer to the table below for the analysis of the problem and the procedure to follow to correct it If the problem persists after a new cycle start notify t
25. e outlet must be 3 8 inch Instead of the N bottle the GENERATOR TROLLEY ref 94222 with incorporated Nitrogen Generator can be used In this case i the tube is directly connected to the outlet of the nitrogen ato generator After turning it on the generator starts charging 1 bar hour until it reaches 6 7 bar It is advisable to turn it on at least 4 hours before starting a cycle requiring a modified atmosphere Campylobacter Limitations and Warnings IN CASE OF FIRE OR GENERAL DANGER TURN OFF THE INSTRUMENT AND UNPLUG THE POWER CABLE It is prohibited to OPERATE on the instrument while parts are moving only the keyboard may be used to key in commands It is prohibited to INTRODUCE the fingers and objects between the tray and the cover of the instrument It is strictly prohibited to MOVE the tray by hand when the instrument is running a cycle Operations to uninstall and reinstall the instrument in the same room or in a different place Two cases should be distinguished A Uninstallation and reinstallation in the same room or in a place reachable with trolleys and lifts for this procedure it is not necessary for authorised personnel to be present 1 Turn off and disconnect the two power supplies PC and module Release the trolley wheels and carefully move the instrument to the new working position If there is no trolley fit the handles on the ROBOBACT module lift it and position it in the new positi
26. ed in percentage and with 19 progressive colouring e Incubation end date and time The background turns green if already terminated mu 19 The Job print key allows printing the job list if the samples are loaded by matching the barcode A printer is required connected to the PC The Graphs key allows viewing the temperature trend recorded in the last 24 48 hours of operation Moving with the Previous Next keys to the previous pages you can also view the trend in the last 5 days of module operation Temperature chart In cycle Unplugged 1 14 2010 6 41 AM 1 15 2010 12 40 AM Not monitored 12 18 24 6 12 18 24 As the hours go by a line is drawn for the temperature trend with the following characteristics In the event of a power failure you can estimate how long the instrument has been off from the length of the line drawn The temperature range displayed is between 15 C and 50 C Points outside this range are not displayed The Robobact Special module allows you to view the Oxygen and pressure trend in the incubation chamber in the last 24 48 hours of operation Moving with the Previous Next keys to Oxygen pressure chart Oxygen in cycle Pressure in cycle Unplugged 1 14 2010 6 41 AM 1 15 2010 12 40 AM Oxygen in idle Pressure in idle Not monitored 48 00 mbar 40 00 mbar 32 00 mbar 24 00 mbar 16 00 mbar Jequ aunssa d 8 00 mbar 0 00 mbar Rev 2 01 USB 27
27. he Authorised Technical Service Description Error during sample tray movement Error on sensor inside the clamp Error in locking or unlocking the door Delay in sample tray movement Error in clamp closing Error in clamp opening Error during horizontal clamp reset Error during vertical clamp reset Rev 2 01 USB Procedure Move the tray by hand if the movement is obstructed remove all the devices and retry if it moves smoothly check for dirt or debris plastic parts etc in the housings where the devices are positioned remove and reinsert some devices and retry The sensor does not see the emitter 1 This may occur when during a reset the clamp is positioned on the device The clamp closes with the ball on the inside Press START again 2 There may be some dirt on the clamp sensor 3 One of the sensor cables is broken Only on the Special module Notify the Authorised Technical Service Notify the Authorised Technical Service Notify the Authorised Technical Service Notify the Authorised Technical Service Notify the Authorised Technical Service Notify the Authorised Technical Service 33 36 ROBOBACT USER MANUAL Errors displayed in the status row of the position occupied by the sample When the window is red the message points out a problem related to the device present in that position Example Error Type Rescan Barcode error Seeding error Ball up
28. instrument for a period of 12 months from the date of delivery the date on the transport document shall be valid for material or manufacturing defects Should the product prove to be defective during the warranty period the authorised Technical Service Centres will repair it free of charge debiting only the transport costs where applicable Warranty conditions 1 This product shall not be considered defective in terms of materials and manufacture if it has been adapted modified or adjusted to comply with national or local standards different from those for which the product was originally designed and constructed 2 This warranty does not cover periodic inspections maintenance and repair of parts subject to normal wear transport costs and risks directly or indirectly related to the warranty of this product including transport from the Technical Service Centre to the domicile of the customer damage caused by negligence or improper use of the instrument malfunctioning of the instrument caused by modification or repairs made by unauthorised third parties damage caused by installation of parts not approved by the manufacturer Rev 2 01USB 8 36 Characteristics PROCEDURE ROBOBACT USER MANUAL Materials required for use of the instrument Exclusively use the materials of the Robobact line manufactured by DIESSE DIAGNOSTICA SENESE S p A always read the instructions for use that accompany each product before
29. lace by looking at the sections of the loops on the culture medium If the problem occurs often notify the Authorised Technical Service If it is a new sample check if the device loop is in the correct position if it is slightly up push it down and retry or if it is defective If otherwise notify the Authorised Technical Service In the Methods section check if any methods have been deleted or modified and if so press the RESTORE key If it is a new method enter the information on the new code Name Type Incubation Temperature Enrichment Time and Incubation Time using the NEW key Otherwise notify the Authorised Technical Service The cycle is NOT started Remove the incompatible device and retry Thee cycle is NOT started Remove the incompatible device and retry WARNING In the event that a USB connection is broken connection of a Robobact module the Robobact Manager software automatically searches for and restores the connection During this time the software may restart in this case the Windows desktop is displayed for a second and immediately afterwards the Robobact Manager program window reappears with the information on all the modules previously connected No data is lost during this phase and no operation on the modules and on the samples is interrupted Rev 2 01 USB 34 36 ROBOBACT USER MANUAL Appendix A EC DECLARATION OF CONFORMITY In accordance with 98 79 EEC regulation regarding In Vitro Medi
30. nu Methods Pressing the METHODS key a new window is opened where you can view and change the enrichment time and the incubation time in hours for each method Ctrl M A password must be entered to access the Methods menu in this case the password is ds Type in the letters ds and then press Enter Rev 2 01 USB 24 36 CAUTION It is advisable to change only the enrichment and incubation TIMES DO NOT change the other characteristics of the method without permission of DIESSE Exit Ctrl X ROBOBACT USER MANUAL Methods Method code foot Method description Salmonella Shigella ow Yersinia Aeromonas Method type Stool im v Coli Staphylococcus Temperature 137 Enrichment time w Urine culture Incubation time w Throat sw S aureus Par test 02 fill N2 x10 ow Vaginal sw Candida 02 fill CO2 x10 w Rectal swab i Device type v Rectal swab Streak ID On the left you will see the complete list of methods highlighted by type Stool Urine Swab Selecting the method you can view its characteristics Method description Method type Temperature Enrichment time Incubation time You can change each one of these characteristics by selecting the active window relating to the parameter to be changed a virtual keyboard will appear i enter the new value and press ENTER
31. obact Special module temperature set shown in small font in green when samples requiring a controlled atmosphere are present 7 0 In addition proper functioning of the electrovalves that diii allow NITROGEN N2 and CARBON DIOXIDE CO to CO not available Bottle empty flow into the instrument is indicated as follows Le N2 not available Bottle empty The Sample Table shows all the information relating to the 35 positions of the instrument each row represents a position The empty rows represent unoccupied positions not containing samples Eee Pas Sample code Test code Start Time Enrich Time B amp S Time Incub Time End Time DI Urine culture plus 04 June 08 43 i 04 June 08 43 1 05 June 14 30 For each position occupied the following are indicated in order Rev 2 01 USB 26 36 Job print Graphs Oxygen Temperature C 25 0 20 0 15 0 F2 F3 ROBOBACT USER MANUAL e Samplecode showsthe barcode of the sample if inserted see the paragraph Sample insertion e Method description shows the name of the test e Start date and time shows the start date and time of the first cycle for that sample e Enrichment time progress indicated in percentage and with progressive colouring e Sample seeding date and time date and time for breaking and seeding the sample The cell turns green if already done e Incubation time progress indicat
32. on chosen then remove the handles Move the computer using the specific handle and reconnect the two power supplies B Uninstallation and reinstallation in a different place or in a place NOT reachable with trolleys and lifts This procedure requires authorised personnel to be present Rev 2 01 USB 18 36 For DISPOSAL of the instrument at the end of its life cycle refer to the local waste disposal regulations in force ROBOBACT USER MANUAL Instrument composition Disposal The instrument is made up of the following materials expressed in percentage rons PLASTIC MATERIALS PVC ABS etc 7 4 Rev 2 01 USB 19 36 WARNING The instrument runs the SOFTWARE and HARDWARE reset functions and initialises a test program to check the efficiency of the motors and all the instrument functions USE Instructions for the operator Instrument programming Sample loading Before reading this section of the manual it is important to read the previous chapters in order to avoid problems with the instrument and for the operator Turning on the instrument Check that the power supplies of the instrument are connected to the mains and that the module and the computer are connected to each other with the USB cable Turn on the ROBOBACT module with the power switch on the left hand side of the instrument Follow the on screen instructions and observe the green LEDs on the inside of the ROBOBACT d
33. oor Rev 2 01 USB 20 36 ON MODULE SHOWN ON THE DISPLAY WORKING SESSION STARTED ENRICHMENT PHASE ACTIVE ERROR SIGNALLING ROBOBACT USER MANUAL Description of the LED indications A series of GREEN LEDs are housed on the inside of the door at the bottom of the instrument arranged as shown below 1 2 3 4 5 6 When they are on they are well visible from the outside through the transparent part of the door They indicate the following The first small LED on the left 1 indicates that the module is ON The two large LEDs 2 and 3 come on simultaneously to form one single luminous bar When they come on it indicates that the software information shown on the display relates to that module useful information if using several Robobact models When the small central LED 4 comes on it indicates that the module is running a cycle or that the instrument has started a working session The farthest right LED 6 indicates instrument agitation it FLASHES UT the enrichment phase and comes on fixed or is off when agitation is inactive Co ES uN Ie N When the second last LED 5 the second one from the right is on it indicates that an error has occurred during instrument operation Rev 2 01 USB 21 36 ROBOBACT USER MANUAL Description of the Robobact Manager menu If all the motor reset tests are OK the main page of the Robobact Manager program is displayed A module management window
34. r that type of examination In addition an optical sensor positioned at the height of the spherical end of the seeding fork determines its status identifying whether or not a sample has already been seeded This unit is composed of four stations positioned underneath the sample tray in each of which there is a horseshoe shaped magnet The magnets are rotated by means of a belt driven by a motor at 450 rpm The rotating magnet moves the mixing rod housed in the sample containers encouraging enrichment Rev 2 01USB 11 36 Unit for breaking open the bottom of the sample container Seeding unit Any personal computer with similar features and with MS Windows XP Vista or 7 operating system and USB ports may be used ROBOBACT USER MANUAL This unit consists of a metal block with up down movement transmitted by means of a worm screw driven by a stepper motor When the block moves down it pushes the sample container down to break open the bottom of the container and hence allow the liquid to flow into the culture medium section of the device This unit consists of an arm at whose end a clamp is positioned the clamp jaws have an open close movement The arm makes two movements up down and forward backward When it moves down the clamp is positioned on the spherical end of the device seeding fork and the closing movement of the clamp jaws is activated to grip the spherical end A sensor positioned inside the jaws checks its presence
35. s can be connected to the computer Figure 2 1 The power cable for the Robobact module or Robobact Special module must be type Female Plug IEC 320 C 13 Male Plug Schuko EEC 7 VII Rating 10A 250VAC Less than 3 m long Various peripheral devices such as a mouse external keyboard printer etc can also be connected to the computer Rev 2 01USB 13 36 ROBOBACT USER MANUAL Technical features ROBOBACT and ROBOBACT Special modules POWER SUPPLY 110 220 240 V 50 60 Hz FUSES 2x T5A Delayed ELECTRICAL POWER ABSORBED 1000 W DIMENSIONS 65 x 55 x 50 cm WEIGHT 45 kg OPERATING TEMPERATURE 15 C to 40 C RELATIVE HUMIDITY 20 80 without condensation NOISE below 80 decibel Trolley DIMENSIONS 65 x 55 x 70 cm WEIGHT 30 kg Generator trolley POWER SUPPLY 110 220 240 V 50 60 Hz ELECTRICAL POWER ABSORBED 750 VA DIMENSIONS 65 x 55 x 70 cm WEIGHT 90 kg Unit of measure The units of measure are expressed according to the INTERNATIONAL MEASURING SYSTEM as indicated in the CNR UNI 10 003 Technical Standards Rev 2 01 USB 14 36 Keep the original packaging including the internal parts ROBOBACT USER MANUAL INSTALLATION Packaging Handing and posttoning Equipment Obhgatons of the customer Disposal Installation must be carried out by expert personnel trained and authorised by the distributor ROBOBACT is a precision instrument and must be handled as such Improper operations might d
36. ta 110 220 Vac 50 60 Hz Product Elaboration and control unit Technical data PROCESSING UNIT Type 110 220 Vac 50 60 Hz conforms as a whole and in its parts with the following standards and their amendments EN 61010 1 Safety requirements for electrical equipment for measurement control and laboratory use Part 1 General requirements EN 61326 1 Electrical Equipment for Measurement Control and Laboratory Use Electromagnetic compatibility requirements Part 1 General requirements And therefore meets the minimum requirements of the following Community directives and their amendments Low Voltage Directive 2006 95 EEC Electromagnetic Compatibility Directive 89 336 EEC 93 68 EEC and 2004 108 EEC Place date of issue Monteriggioni 01 April 2009 Signature Francesco Cocola General Manager This is the certified copy of the original document stored in archive of DIESSE Diagnostica Senese SpA i Issued Monteriggioni 23 July 2010 ff Mor AG Gabriele Monciatti R A Manager Rev 2 01 USB 36 36
37. the voltage and current specifications indicated on the metal plate affixed on the rear of the instrument The mains must be connected to earth according to the regulations in force The instrument is equipped with an internal stabilizer that withstands voltage variations of 10 If the electric line is strongly disturbed use an external stabilizer Before connecting external devices printer display keyboard etc check their compatibility Before turning on the instrument it is advisable to check that the sample tray is free of foreign matter which might compromise its rotation Rev 2 01 USB 16 36 Exclusively use the power cables provided ROBOBACT USER MANUAL It is prohibited to Remove or modify the safety and protection devices Remove or insert the device when the sample tray is moving Introduce foreign bodies into the instrument Access internal areas not permitted P Installation procedure 1 Unpack the instrument in CRATE A Undo the 4 retaining screws on the cover of the wooden crate one per side and the other 4 screws on the base of the crate using a screwdriver Lift the cover check the contents against the packing list remove the box containing the computer if present and then remove the side panel of the crate pulling it upwards 2 Unpack the trolley in CRATE B as done for CRATE A and position the instrument First position the trolley and lock the wheels with the brakes
38. tray rotation motor needs to be disabled and the tray moved by hand to insert the samples AUTOMATIC METHOD allows inserting the samples by matching the barcode of the sample and its position in the tray The tray is automatically moved in groups of five positions at a time To proceed with inserting the samples go to the main page of the module the instrument must be in READY state shown in the dialogue window If the instrument is running a cycle stop it by pressing the Stop Cycle key The cycle can be interrupted at any time Any samples already present are held in memory and will be recognised when the cycle is restarted and their treatment will resume from where it was interrupted Insertion using the MANUAL METHOD If the instrument is in Ready state open the door following the sequence shown in the figure all the samples to be examined have been inserted or when reaching the maximum N Insert the device in the accessible housings and move the tray forward by hand until CEN Capacity of the instrument 35 samples Then close the door following the sequence in reverse order Press the Start Cycle key At this point the door is locked and the cycle is started beginning with the identification procedure To stop the cycle press Stop Cycle When the module goes back into Rev 2 01 USB 29 36 ROBOBACT USER MANUAL Ready state you can open the door and retrieve the samples for which the analysis has been completed
39. ture plus 08 43 4 Ju 1 05 June 14 30 02 Urine culture plus 04 June 08 43 e OS 1 05 June 14 32 03 Urine culture plus 04 June 08 43 04June08 43 1 05 June 14 34 04 Urine culture plus 04 June 08 43 04June08 43 0 05 June 14 36 os Urine culture plus j une k 05 June 14 38 06 nia ae aims _ I itaca Ready Job print 07 Urine culture plus 28 May 10 22 28 May 10 22 eo sE May 10 27 4 F2 08 Urine culture plus fay 10 22 n i Dialogue window position 09 Urine culture plus na 10 Urine culture plus in Wide Screen mode In 1 Urine culture plus B 12 ja S normal display mode 13 Urine culture plus m Urine culture plus 3 02 Sound ol these windows are 15 Urine culture plus rel Has 16 Urine culture plus l positioned at the bottom 17 Urine culture plus 29 May 17 0 18 Urine culture plus 03 June 11 29 June 11 25 05 June 10 08 s i a 14 49 31 20 21 22 Service 23 ral 24 25 26 27 28 29 30 31 32 33 nirccce 34 35 Description of the information displayed in the dialogue windows Robobact module number Firmware release Module identification number assigned during 3 02 Indicates the module installation firmware version Function message window Date and time 14 49 31 System date and time read indi by the PC indicate the module O activity Current and set temperature status rt 02 and pressure 11 06 mbar the symbols OK High Low status Only in the indicate the status with respect to the Rob
40. uage from those available Options English United Kingdom tai Spanish Spain Connections Italian Italy Alt C Chinese People s Republic of China General Alt G The CONNECTIONS option allows changing the module numbering Select the module of which you want to change the numbering move it with the Move up Move down keys until it is in the desired position Languages Alt L You can display a name or serial number settable from the SERVICE menu for each module next to the module number General ace The Robobact Manager software must be restarted to make the changes effective Close Move Down Delete Ctrl D Canc Esc A The GENERAL option allows making other settings such as the temperature and pressure measurement scales Options Temperature Pressure Languages Fahrenheit F Pascal Pa Alt L Pound square inch Psi j Connections Alt C Virtual keyboard Lal Wide screen Progress time scale Hours X Rev 2 01 USB 23 36 ROBOBACT USER MANUAL Among the options available is the possibility of changing page display from WIDE SCREEN to STANDARD If you have a display with 16 9 screen and select the WIDE SCREEN function the dialog windows will be arranged on the right hand side of the screen when the module page is displayed When selecting the CLOSE option you return to the main menu From the main me
41. will appear on the screen for each instrument connected with a different number and colour The information relating to the module connected is summarised in each window Robobact Manager List of information Status Cycle Running or Ready Temperature No of unoccupied positions No of samples being processed No of samples completed If using an external keyboard if the touch screen function is not Firmware release version 4 available you can press the function keys indicated at the bottom right of each key to activate the corresponding function On the right hand side of the page the following commands for the common functions are available Sn 128 Pressing the About key the information on the the Robobact Manager software version is displayed fo To y Ty sit ae Robobact Manager version 1 0 0 7 About Copyright Diesse 2009 Diesse l Ctrl A OK Pressing the MULTIPLE START key the cycles on all the connected modules are simultaneously started When the modules are running a cycle the key changes to MULTIPLE STOP Pressing the key all the modules that are running a cycle are stopped Methods LL Ctrl M Options Cti 0 Exit Pressing the OPTIONS key a new window is opened containing 4 function keys Ctrl LANGUAGES CONNECTIONS GENERAL CLOSE mircce Rev 2 01 USB 22 36 ROBOBACT USER MANUAL The LANGUAGES option allows selecting a lang
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