InnuPure C16
Contents
1. 2x4 AT 250V Identification of the internal fuse Only use the specified fuses WEEE identification of electrical The device must be disposed of and electronic equipment separately from household waste as electrical and electronic waste after its useful life has expired 10 Edition 09 2012 InnuPure C16 3 4 3 9 3 6 InnuPure C16 Safety instructions Technical condition The InnuPure C16 corresponds in its design and construction to the current state of the art technology Unauthorized modifications or changes especially such that affect the safety of the staff and the environment are generally not allowed Observe the following notes Q D The operator must only operate the device in a sound and operationally safe condi tion The technical condition must always comply with the legal requirements and regulations Prior to every use the device must be checked for damage and sound condition Any changes in the device affecting its safety must be reported by the operating personnel to the operator without delay Requirements for the operating personnel Observe the following notes Q Q The InnuPure C16 must only be commissioned operated and serviced by trained personnel instructed in technical safety The operation or servicing of the device by minors or individuals under the influ ence of alcohol drugs or medication is not permitted It must be ensured that only authorized personn2. use desiccant 8 Edition 09 2012 InnuPure C16 3 1 InnuPure C16 Safety instructions Safety instructions General notes For your own safety and to ensure error free and safe operation of the InnuPure C16 please read this chapter carefully before using the appliance Comply with all safety instructions in this user manual and pay careful attention to all mes sages and notes which are displayed on the screen by the program You must also comply with the safety instructions on the labels as well as the information on handling storage and disposal of the kits Besides the safety instructions in this user manual and the local safety regulations that apply to the operation of the device the general applicable regulations regarding accident preven tion occupational health and safety and environmental protection have to be observed and complied with References to potential dangers do not replace the work protection regulations which must be observed Symbols and signal words used in the user manual The user manual uses the following symbols and signal words to indicate hazards or instruc tions The safety instructions are always placed before an action CAUTION Indicates a potentially hazardous situation If it is not prevented light or minor injuries and material damage can result ATTENTION Indicates a potentially hazardous situation Unless avoided the product or items in its vicinity may be damaged IM
3. new software version the actual update LJ IPCupd exe tool executing the update The steps required for an update are described below 1 44 Switch on the InnuPure C16 Edition 09 2012 InnuPure C16 InnuPure C16 Maintenance and care 2 Wait for the device to initialize beeping sound and log in if necessary 3 Insert the USB stick into the USB port at the right hand side of the HID Pro 320 4 Inthe main menu press the button SETTINGS 5 Press UPDATE 6 Inthe UPDATE menu press the UPDATE button to start the UPDATE TOOL 7 Inthe main menu of the UPDATE TOOL press the UPDATE SOFTWARE button 8 Inthe menu SOFTWARE UPDATE press the UPDATE button v The update is executed automatically and is complete as soon as the Close is displayed again after approx 3 4s 9 Press CLOSE to exit the SOFTWARE UPDATE menu 10 Exit the UPDATE TOOL with EXIT 11 Switch the device off and back on to perform a re initialization v The InnuPure C16 is ready for operation again Note The software update is not tied to user rights It can be executed by any user Edition 09 2012 45 Transport and storage 9 9 1 9 1 1 46 Transport and storage Transport Preparing the device for transport ATTENTION For packaging only use the transport packaging recommended by AJ Only this provides optimum protection of the InnuPure C16 against transport damage Pack the InnuPure C16 as follows 1 Remove r
4. Wizard 1 4 Page 14 Please wat Magnet test tool is starting in process Step time 00 00 14 A sample tray must be in the device to execute the tools If this is not the case when a tool is started a prompt to insert the tray is automatically displayed The following tools have been integrated into the program Too Funcom S O O Adjusting the sample tray position for correct tip removal EMPTYING TIPS Emergency emptying of strips and plates during protocol abortion into IN CAVITY 3 the 3rd cavity to discharge fluid from the tips in a controlled manner The sample tray must be populated with corresponding strips and plates Control of the heating function Initialization of the InnuPure C16 after protocol abortion or after an error InnuPure C16 Edition 09 2012 35 Operation MAGNET TEST Control of the positioning of the magnet unit TRANSPORT LOCK _ Arresting the transport lock for minor transports moving within the lab IN TIPLINE 1 TRAY OUT Release of the sample tray from the device WASTE TIPS Ejection of the filter tips into the 3rd cavity after a protocol abortion IN CAVITY 3 The sample tray must be populated with corresponding strips and plates 6 3 5 Work with user ID management IMPORTANT A user with administration rights has been configured in as default Password IPC16 User name Administrator User rights Within the user administration the rights can be ass
5. Blood mini 16 01 Plant DNA 016 01 virus C16 01 Edition 09 2012 InnuPure C16 InnuPure C16 Operation Enter the eluate volume in 25 ul steps een If the volume has not been entered in 25 window ul steps the volume is rounded off by the program Volume values 100 125 150 500 ul EV 100p1 S00pI Check that the entered eluate volume has been accepted in the status line of the window in accordance with the inputs and confirm the query with OK Please watt the protocol is started EV value in the status line correctly Ok yes Cancel no abort Protocol wzp Wizard 141 Page 1738 A check is performed during protocol start seer ihe P whether the sample tray is already in the de protocol is started vice If not a prompt appears to insert the wa sample tray now This is followed by a device calibration Calibrate ai The status line displays a blue progress bar 2 Belt the remaining time till the end of the extraction protocol and the remaining time of the current step in process Remaining time 00 11 30 Step time 00 00 05 Edition 09 2012 31 Operation Protacolwzp Wizard 11 Page 3 35 in process Remaining time 00 10 22 Step time 00 00 11 CAUTION Risk of burns 32 Edition 09 2012 Whilst the extraction protocol is run the current step is displayed and symbolized by a pictro graph On the right side of the window the pictographs of
6. Figure HIDE Pro 5320 areas enerne Seen 18 FOUE Gs SET MIdO0M users eres eee 24 Figure 9 Program overview of the InnuPure C16 rrrarrrrarannarennnnrnnnnnnnnrnnarennnnennnnnnnnnennnne 29 Figure 10 Switching the interior light on enabling the touch sensor rrranrrranrnnnnevnnnrvnnnn 38 Figure 11 Window for configuring date and time rrrrnnnnnnnanannanennnnrnnnnnnnnnnnnnnennnnnnnnennnnennnee 39 Figure 12 Open Tuse Nolder varaner ee 44 Edition 09 2012 3 Figures 4 Edition 09 2012 InnuPure C16 1 1 1 2 InnuPure C16 Basic Information Basic Information User manual notes The InnuPure C16 is intended for operation by qualified specialist personnel observing this user manual The user manual informs about the design and operation of the InnuPure C16 and provides personnel familiar with the isolation and purification of nucleic acid the necessary know how for the safe handling of the equipment and its components The user manual further includes notes on the maintenance and service of the equipment and potential causes and remedies of any faults User manual conventions Instructions for action which occur in chronological order are numbered and combined into action units and furnished with the corresponding results Lists which are not in chronological order are shown as itemized lists sub listings as bullet points Safety notes are indicated by pictogaphs and signal words The type and source of the danger are
7. directly into the sample tray For populating the sample tray the tray must be placed into the priming station supplied Positions 1 and 3 of the strips and plates are used as ejection location for used tips later in the process For the correct operation of the tip ejection it is absolutely necessary that these positions are fully opened at least 7 mm diameter with the optional perforation tool or an other suitable tool before starting The loaded sample tray is inserted into the adapter in the front door 3 in Figure 2 p 16 and then automatically pulled into the correct position in the InnuPure C16 1 Filter tips 2 Elution vessels for purified samples 3 Tip block 4 Pressure pad 5 Sample block for reagent plates or adapter for reagent strips 6 Serrated guide rail a Adapter for reagent strips P 6 gt 4 Figure 5 Sample tray InnuPure C16 Edition 09 2012 17 18 Technical description Figure 6 Priming station and optionally available perforation tool The InnuPure C16 uses the flexible and portable control unit HID Pro 320 with the large 5 7 touchscreen The integrated PC on Windows CE basis enables the use of typical Win dows functions with a clearly structured menu interface Thus the entire system becomes a stand alone device For the review of the running extraction the status of the current step is displayed in realtime The user can thus follow every routine clearly and continually Via the USB por
8. error message and notify the service department of Analytik Jena AG Error messages Possible error message Command incorrect Slave response incorrect Calibrating error Z axis Calibrating error Y axis Positioning error Y axis Positioning error Z axis Positioning error P axis Positioning error M axis Positioning error ejector Initialization error Y axis Initialization error Z axis Initialization error P axis Initialization error M axis Initialization error ejector Reading default values failed Writing default values failed Reading calibrate values failed Writing calibrate values failed Runtime Error Maxdiff value Y1 axis exceeded Maxdiff value Y2 axis exceeded Maxdiff value Z axis exceeded Maxdiff value P1 axis exceeded Maxdiff value M axis exceeded Edition 09 2012 Meaning Internal command incorrect incomplete Response from 2nd control incorrect incomplete Error during the calibration of a drive axis Error during the positioning of a drive axis Error during the initialization of a drive axis Reading or writing of the default values failed Reading or writing of the calibration values failed Undefined error Maximum permissible position deviation exceeded in a drive axis InnuPure C16 7 2 InnuPure C16 Maxforce value Y1 axis exceeded Maxforce value Y2 axis exceeded Maxforce value Z axis exceeded Maxforce value P1 axis exceeded Maxforce value M axis exceeded Difference temperature sensor va
9. only release the sample tray use the tool TRAY OUT Edition 09 2012 InnuPure C16 Maintenance and care 8 Maintenance and care The InnuPure C16 is mainly maintenance free Care and maintenance are limited to cleaning the device changing the fuses and installing software updates CAUTION The device cover must only be opened by the technical customer service of Analytik Jena AG or its authorized agency Before opening the device cover disconnect the mains plug 8 1 Cleaning the InnuPure C16 CAUTION Danger of electric shock Before cleaning the device with disinfection agents disconnect the mains plug from the con nection of the InnuPure C16 The InnuPure C16 must only be recommissioned once it is completely dry Clean the InnuPure as follows LJ Avoid contamination by handling sample substances with care LI Wipe spilled samples or reagents immediately with an absorbent cloth or piece of paper LJ If the InnuPure C16 is used for the analysis of infectious material great care must be taken because the InnuPure C16 cannot be decontaminated as a whole device LJ Visible contamination must be removed immediately using suitable detergents making sure that no solvent enters the inside of the device Q The drip tray can be removed from the device for cleaning with the door open Caution The magnet heating elements must not be in the up position LJ The adapters for accepting the reagent strips can be autoclave
10. phase alternating current The installation of the electrical equipment of the laboratory must comply with the standard DIN VDE 0100 After the connection point an electrical current in accordance with the standard IEC 38 must be available Connecting the InnuPure C16 and switching it on off IMPORTANT Retain the transport packaging Return transport for service must be in the original packag ing This alone prevents transport damage Connecting the InnuPure C16 1 Take the InnuPure C16 out of the packaging 2 Check the device for completeness and soundness 3 Insert the control unit HID Pro 320 into the interface on the front of the InnuPure C16 1 in Figure 2 p 16 4 Connect the mains cable at the rear v The InnuPure C16 is now ready for operation Switching on the InnuPure C16 ATTENTION When switching on the InnuPure C16 no USB stick must be connected to the control unit HID Pro 320 The user date on the HID Pro 320 could be overwritten 1 Switch the InnuPure C16 on from the mains switch at the equipment backplate 2 Activate the InnuPure C16 via the touch sensor on the front of the device Touch the sensor for approx 3 s until the red illuminated status indication changes to green and the control unit HID Pro 320 switches on Note The switch is a capacitive button that could be damaged by strong pressure Only touch the button lightly y The InnuPure C16 is initialized automatically The process takes appr
11. stated together with notes on preventing the danger The meaning of the picto graphs and signal words used is explained in the chapter Safety notes The elements of the control program are indicated as follows LJ Program terms are identified with SMALL CAPS LJ Buttons are shown by square brackets e g OK button LJ Menu items are divided by an upright line e g FILE OPEN Intended use The InnuPure C16 is a flexible and efficient extraction system for the fully automated isola tion and purification of nucleic acid in chemical and biological laboratories In the field of medicine and diagnostics its used is limited to research The InnuPure C16 including its original accessories must only be used for the applications described in this instruction manual The manufacturer does not accept liability for any other use including that of any individual modules or components Q The device must only be operated by qualified and trained personnel LJ The device must only be used in accordance with this instruction manual This ap plies in particular to the adherence to the connection values conditions of use and notes on maintenance service transport and disposal LJ The safety notices in this instruction manual must be observed Edition 09 2012 5 Basic Information 1 3 It is not permissible Q E Q E to work with explosive substances in this device to operate this device in an explosive environment to use cons
12. the previous current and next step are also displayed from top to bottom By pressing the STOP button the extraction protocol can be aborted after acknowledging the message ABORT with OK However the current command will still be completed Select CANCEL if you want to continue the extraction protocol To return to the start win dow after aborting a protocol press the x button at the top right in the window Note During a step in which the filter tips are ejected the STOP button is disabled Do not reach into the device interior immediately after aborting the extraction protocol The magnet elements may be up to 80 C hot at this time but cool down to 50 C within 5 min InnuPure C16 Operation 6 3 3 Copying moving or deleting extraction protocols IMPORTANT Administrator rights are required for moving deleting or copying extraction protocols Extraction protocols have already been pre installed on the InnuPure C16 It might however be necessary to install protocols for a new reagent kit and to delete unnecessary protocols or move them temporarily to external data carriers This administration of the extraction proto cols takes place in the protocol window The data transfer when moving or copying always takes place between a USB stick Stick and the memory card in the HID Pro 320 Card A folder Wizard must be present on the USB stick containing the program folders to be copied or to which pro
13. 3 p 16 to position v The LED of the touch sensor illuminates permanently green Now the In nuPure C16 only can be switched on and off at the mains switch 24 Edition 09 2012 InnuPure C16 Operation 6 Operation 6 1 Preparation of the buffers and solutions All buffers and solutions are provided in pre filled and sealed reaction cups reagent plates or strips dependent on the isolation routine and source material The preparation of the sample tray has been described in detail in each kit manual and section Preparing the sam ple trays p 25 Follow the instructions described in the preparatory steps within the kit components of the kit manual It is recommended to preheat the thermal mixer for some steps of the lysis in ac cordance with the kit manual 6 2 Preparing the sample trays and inserting them into the InnuPure C16 CAUTION Nickel allergy The sample tray is coated with nickel IMPORTANT Use the priming station to populate the sample tray The filter tips are longer than the tip block and would impact against the table top Prior to extraction the sample tray must be loaded with the reagent plates and or reagent strips of the kit used In the example the sample tray is populated with a reagent plate and four reagent strips When inserting the plates and strips always ensure the correct orienta tion Move the sample tray into the priming station and fold the holding down clamp at the sample tray
14. 30 C The following requirements are placed on the location of the InnuPure C16 LJ Donot locate the device directly near a door or window I Place the device on a stable surface LI Do not locate the device near sources of electromagnetic interference E Avoid direct sunlight and radiation from heaters onto the device if necessary en sure air conditioning D Never cover the front door and the air vents of the device with other equipment or installations Q Keep a safety distance of at least 5 cm from the rear of the device to other equip ment or walls Space requirement The space requirement results from the device dimensions Closed device W x D x H 380 mm x 530 mm x 435 mm Device with open front door W x D x H 380 mm x 920 mm x 435 mm Sample tray W x D x H 200 mm x 250 mm x 83 mm Priming station W x D x H 210 mm x 260 mm x 165 mm The loaded sample tray is moved through the opening in the door into the device The device door must be opened for cleaning and maintenance purposes and must therefore be added to the dimensions The air vents on the rear of the device must remain unobstructed to ensure air circulation Edition 09 2012 InnuPure C16 5 2 InnuPure C16 First commissioning Energy supply WARNING The InnuPure C16 must only be connected to a properly grounded mains outlet in accord ance with the voltage specifications on the type plate The InnuPure C16 is operated on single
15. Because the device does not have carrying handles grip the device firmly with both hands at the lower device end Make sure the doors are closed before lifting the device simultaneously Observe the guide values and adhere to the legally mandated limits for lifting and carrying without auxiliary means LJ For the setup at the new location observe the notes in section Site requirements p 22 Edition 09 2012 InnuPure C16 9 2 InnuPure C16 Transport and storage Storage CAUTION Environmental influences and condensate formation can destroy individual components of the device The device must only be stored in air conditioned rooms The atmosphere must be low in dust and free from aggressive vapors If the device is not installed immediately after delivery or not required for prolonged periods it should be stored in its original packaging A suitable desiccant should be added to the equipment to prevent damage from moisture The following storage conditions must be met Q Temperature range 10 55 C Q Max humidity max 80 use desiccant Edition 09 2012 49 Disposal 10 Disposal ENVIRONMENTAL PROTECTION At the end of its service life the InnuPure C16 and all its electronic components must be dis posed of in accordance with the applicable regulations as electronic waste 50 Edition 09 2012 InnuPure C16 CyBio An Analytik Jena Company EG Konformit tserkl rung EC Declaration of Conformity
16. Name und Anschrift des Herstellers Name and address of the manufacturer CyBio AG G schwitzer Stra e 40 D 07745 Jena Hiermit erkl ren wir dass das nachstehend beschriebene Produkt Herewith we declare that the product described below InnuPure C16 30 7115 001 26 Seriennummer ccc ccccceecccccccaucctecccevseeeceeess allen einschlagigen Bestimmungen der Maschinenrichtlinie 2006 42 EG entspricht Das Produkt entspricht zus tzlich den Bestimmungen der europ ischen Richtlinien 2006 95 EG Uber elektrische Betriebsmittel und 2004 108 EG ber elektromagnetische Vertr glichkeit is complying with all essential requirements of the Machinery Directive 2006 42 EC In addition the product is in conformity with the EC Directives 2006 95 EC relating to electrical equipment an 2004 108 EC relating to electromagnetic compatibility Angewandte harmonisierte Normen Harmonized Standards used Sicherheit von Maschinen Allgemeine EN ISO 12100 03 2011 Gestaltungsleitsdtze Risikobeurteilung und Risikominderung Safety of Machinery General principles for design Risk assessment and risk reduction 3 Fie F Safety requirements for electrical equipment EN 61010 1 07 2011 Jeneinelsbestimmungen f r eb ie for measurement control and laboratory Mess Steuer Regel und Laborger te FA Elektrische Mess Steuer Regel und Electrical equipment for measurement EN 61326 1 10 2006 Laborger te EMV Anforderungen control an
17. PORTANT Indicates application hints and other especially useful information without any resulting haz ardous or damaging situations ENVIRONMENTAL PROTECTION Indicates application hints and information to aid the proper disposal and handling of the substances and materials used Edition 09 2012 9 Safety instructions 3 3 Safety marking at the InnuPure C16 Safety and notice symbols have been attached to the InnuPure C16 whose content must always be observed Damaged or missing safety and notice symbols can cause incorrect actions leading to per sonal injury or material damage The symbol labels must not be removed Damaged symbol labels must be replaced without delay Figure 1 Safety symbols at the front and rear of the InnuPure C16 Warning symbol Meaning Remark Warning against a hazard loca Warning against mechanical danger tion from moving equipment parts A Biological hazard Warning against damage from bio logical substances Observe corre sponding protection instructions A Reaching prohibited during op Warning against crushing by moving eration parts Notice symbol Meaning Remark Before opening the device al Before opening the device ways disconnect the mains plug Switch off the device and disconnect the mains plug from the mains sock et and the device Observe the instructions for Prior to starting work read the in AA use structions for use
18. Qlfferent USE Las 38 6 3 6 Switching the interior light on and enabling the touch sensor 38 873 7 COMMOUNIMNG NE INE zen entre 39 Faul removal nee 40 Gal JETORMMCSSAGCS Lee 40 7 2 Notes on preventing errors cccccccccssecccesececeseecceseeceeseeeueseessaeeecsueeensueeeneees 41 Maintenance and CALC sossen E E 43 8 1 Cleaning The IANURUTe G10 Arrr ae 43 8 2 NNN EN 44 8 3 Sollware UDO ALC NAN 44 Transport nd Storage 46 9 1 TSN SPR 46 9 1 1 Preparing the device for transport cccccscccsseecseeecesecceeseueeseueeseeeseeeeseeens 46 9 462 Transpor notes ana 48 9 1 3 Moving the device in the laboratory 0002000000000020en neuen neuen nnnnn nennen 48 92 DOG ersehen 49 DISPOSA licni ira NED 50 EG cConformily declaratii iissa rE 51 Edition 09 2012 InnuPure C16 InnuPure C16 Figures Figures Figure 1 Safety symbols at the front and rear of the InnuPure C16 cece eeeee seers 10 Figure 2 Front view of the InnuPure C16 rrannrnnnrnnanornanernnnevnnnnnnnnnnanrnnanennnnennnnnnnnnnnanennnne 16 Figure 3 Rear connections and switches at the InnuPure C16 u224002240 nennen 16 Figure 4 Device view with open front COOP cccceccecceseeceeeeeceeeeseeeeseeeeseeeeseeeseeeeseeeesaees 17 Foues Sampe AY area erre Senere 17 Figure 6 Priming station and optionally available perforation tool rrranrrrarrrnnnennnnnnnnnnr 18
19. analytikjena InnuPure C16 Extraction system pSaNnqnuut Operating manual analytikjena Manufacturer CyBio AG Goeschwitzer Strasse 07745 Jena Germany Phone Hotline 49 0 3641 351 0 Fax 49 0 3641 351 409 Email info analytik jena de Service Analytik Jena AG Life Science U Konrad Zuse Str 1 TH RINGEN 07745 Jena ENN Germany 15 100 6153 Phone Hotline 49 0 3641 77 94 11 Fax 49 0 3641 77 76 77 76 Email k fritzsche analytik jena de General information about Analytik Jena AG on the internet http www analytik jena de Copyrights and Trademarks Microsoft and Windows are registered trademarks of Microsoft Corp The identification with or TM is omitted in this manual Documentation number 30 7115 002 23 Edition September 2012 Implementation of the Technical Documentation Analytik Jena AG This publication describes the state of this product at the time of publishing It need not necessarily agree with future versions of the product Modifications reserved Copyright 2012 Analytik Jena AG InnuPure C16 Contents Contents ASIC Information nee 5 il User IU NOC Sa reces entice otesnecnaden sane atenansdanaeseeecendoneaeecteanceeese teimeeauaten 5 User manual convenon S SPS 5 122 MENE NN D to Waranty and EDI pre 6 TECHNICAL Ea EEE 7 Safety INSUCHONS nie 9 Sok General Nolo S 544244 9 3 2 Symbols and signal words used in the user manual r
20. ce will only be operable again after these have completed during pure waiting collection steps heating inactive up to 60 s during heated eluation steps up to 100 s during drying steps up to 420 s However switching off from the mains switch results in immediate abortion If a message is present in an overriding window this must be edited acknowledged prior to an abortion Returning to the main screen of the user interface is possible after an abortion by pressing the cross symbol top right in the window During the tip ejection step applicable to all extraction protocols tools it is not possible to abort the protocol using the STOP button The button is disabled during this step During the processing of protocols tools the sample tray must only be inserted by the user after a prompt or only be removed after completion of the protocol even if it pro trudes from the housing After switching off the device min 5 minutes must pass before an intervention in the device is permitted In worst cases the magnetic strip may be up to 80 C hot at the time of switching off but cools down relatively quickly to a temp lt 50 C During the automatic pulling in of the sample tray the overcurrent protection of the tray drives may occasionally trip without an error message being issued The sample tray stops during entry and is not initialized The device can be re activated by restarting any extraction protocol or device function To
21. d and are also suit able for dip and spray disinfection D The sample tray is also suitable for dip and spray disinfectant LI Asa possible disinfection agent we recommend Decosept AF disinfectant spray Fa Dr Schuhmacher GmbH Meliseptol HBV cloths by B Braun Ql Ifthe InnuPure C16 has to be sent to Analytik Jena AG for service after infectious material has been processed with it a prior decontamination must be carried out and documented see documents in the product folder InnuPure C16 Edition 09 2012 43 Maintenance and care 8 2 Changing fuses CAUTION Electric shock Disconnect the mains plug before changing fuses If the fuses in the heat exchanger are faulty you can replace them 1 Switch off the InnuPure C16 and disconnect the mains plug from the connection of the InnuPure C16 Open the fuse holder by pulling its cover Replace the faulty mains fuses Use the following fuses 2 x T 4A 250 V Close the fuse holder Connect the InnuPure C16 to the mains Switch on the InnuPure C16 1 Mains switch 2 Fuses 3 Fuse holder Figure 12 Open fuse holder 8 3 Software update The software update is sent by email Observe the instructions for decompressing and where applicable renaming the files Save the files in accordance with the instruction on a USB stick in the directory IPC16 The following files must then be in this folder LI appfile txt designates the file to be updated LI IPC16 exe
22. d laboratory use EMC Allgemeine Anforderungen requirements General requirements Bevollm chtigter f r die Zusammenstellung der relevanten technischen Unterlagen The person authorized to compile the relevant technical documentation Jochen Eckardt G schwitzer Str 40 D 07745 Jena 7 AA EEE TE ET TE Emm ga a ERREGER EEEE ER HH E Steffen Kammel Leiter Produktion Manager Production
23. ed 1 On the start screen press the button SETTINGS 2 Select the menu item DEVICE COMMANDS 3 Press the LIGHT ON OFF button to switch the light on and back off 4 To re enable the touch sensor press the button TOUCH SENSOR ON Touch sensor on Light ontott Cancel Figure 10 Switching the interior light on enabling the touch sensor Edition 09 2012 InnuPure C16 6 3 7 InnuPure C16 Operation Configuring the time The date and time of the InnuPure C16 are configured via a clock symbol in the top right corner of the start screen 1 Press the clock symbol kl in the start window 2 Set the date and time and confirm the entries with OK ree oe Figure 11 Window for configuring date and time Edition 09 2012 39 Fault removal 7 7 1 40 Fault removal IMPORTANT If faults cannot be remedied by the customer the Analytik Jena AG service department or agency must always be informed This also applies for the repeated occurrence of individual faults In case of an error message perform the following steps LJ Acknowledge the error message with OK Switch the device off and back on E LJ Wait until the beep sounds to signal the completion of the initialization LJ Remove any sample residue and filter tips left behind with the tool EMPTYING TIPS IN CAVITY 3 and WASTE TIPS IN CAVITY 3 If this does not fix the error or the problem reoccurs make a note of the
24. el works at the device The operating personnel must be familiar with the dangers arising from the sub stances used The appropriate protective equipment must be used Safety instructions transport and installation Observe the following notes Q Only transport the device in its original packaging Ensure that all transport protec tions have been fitted and the device is completely empty cleaned and decontami nated The InnuPure C16 may only be installed by service personnel from Analytik Jena AG or by persons authorized by Analytik Jena AG To prevent health damage the following must be observed when moving the device in the laboratory lifting and carrying For reasons of safety 2 persons are required to transport the device and must position themselves on both sides of the equipment Since the device does not have handles grip the device firmly with both hands at the lower end lifting it simultaneously Make sure the door is closed Do not hold from the door area The guide values and statutory limits for lifting and carrying loads without aux iliary equipment must be observed and adhered to Edition 09 2012 11 Safety instructions Sil Safety instructions operation Observe the following notes E The operator of the InnuPure C16 must make sure before each commissioning that the condition of the device including the safety equipment is sound This applies in particular after each modification o
25. emaining consumables from the InnuPure C16 2 Switch off the device and disconnect the mains plug from the InnuPure C16 Insert the sample tray 1 the priming station 2 and the adapters for rea gent strips 3 optional into the spaces in the accessory box provid ed Place the foam cover onto the sam ple tray and place the insert into the priming station Place the HID Pro 320 into the open ing of the insert for the priming sta tion Cover the openings of the sample tray and the priming station with the black foam mats Edition 09 2012 InnuPure C16 InnuPure C16 Edition 09 2012 Transport and storage Place the foam frame for the device base onto the floor of the packaging Warp the InnuPure C16 into the plas tic bag to protect it against scratching and place it into the packaging CAUTION For reasons of safety 2 per sons are required to lift the device and must position themselves on both sides of the equip ment Grip the device firmly with both hands at the lower end lifting it simulta neously Make sure the door is closed Do not hold from the door area 9 Slide the second foam frame for the device top onto the InnuPure C16 Place the accessory packaging be tween the struts of the foam frame for better visibility shown without cover in the photo 47 Transport and storage 48 Cover the accessory insert with the white foam cover and place the card board cover on t
26. gram folders from the memory card of the HID Pro 320 are moved In the example copying of the protocol DNA external Lysis C16 01 to the memory card of the HID Pro 320 is explained step by step Select protocol Load protocol O Blood midi C16 01 O Blood mini 16 01 Plant DNA 016 01 O virus C16 01 Load protocol O Blood midi C16 01 Blood mini 16 01 O Fart DNA 016 01 virus c16 01 Card Edit JM Select Start InnuPure C16 Edition 09 2012 1 Switch on the InnuPure C16 and wait for the device to initialize 2 Connect the USB stick with the file to be copied in the folder Wizard to the HID Pro 320 3 Press the SELECT PROTOCOL BUTTON 4 Press SELECT this makes the menus EDIT and CARD available Now the START cannot be actuated The EDIT contains the three functions LJ Move moving a file to a different data carrier LJ Copy copying a file to a different data carrier LJ DELETE deleting a file on the cur rent data carrier Using the buttons CARD or STICK you can move between the data carriers 5 Press CARD and in the menu select the data carrier containing the protocol to be edited here STICK 33 Operation Load protocol _ Highlight the desired protocols in the list displayed Ef Dra external Lysis C16 01 C DNA internal Lysis C16 0 Inthe EDIT menu select the menu item here Copy and acknowledge the subse quent secu
27. ice Remove the consumables using the tools EMPTYING TIPS WASTE TIPS and TRAY OUT in the TOOLS menu 4 If tips are present at the cones no protocol may be started and the tools AUTOCALIBRA TION and TRANSPORT LOCK may not be executed Otherwise the tips might be dam aged and the device be calibrated incorrectly 5 The InnuPure C16 can be switched off at any time from mains switch at the equpment backplate even whilst an extraction protocol is running Switching off using the touch sensor is only possible if this has been enabled 6 To protect against accidentally switching the device off the touch sensor function is disabled between calibration and the completion of the protocol when protocols tools are run during which fluids are moved Since in the case of an aborted protocol after calibration the touch sensor function is not re enabled automatically this can be per formed by the user via SETTINGS DEVICE COMMANDS TOUCH SENSOR ON 7 During the execution of extraction protocols or device functions the process can be aborted using the STOP button However the last sent command is still completed This has the following effects Edition 09 2012 41 Fault removal 42 10 The device does not stop immediately if a movement command is running The last movement command is still completed During a calibration initialization this may take max 30 s If heating or waiting steps are running the devi
28. igned at two levels Changing user login Exiting the control program of the InnuPure C16 Control of LOGIN AT START Creating deleting users pm Note Service settings are only accessible to service personnel with appropriate access rights Creating modifying a user profile The creation of a user profile or modification of an existing profile takes place via the SET TINGS menu The password can be changed in an existing user profile An administrator may also block the profile of an extended user 36 Edition 09 2012 InnuPure C16 InnuPure C16 Operation Meu e 1 Inthe start window press the button SET TINGS 7 tf Select a ANE ss b nn T Sx gt CNA Life Science unlimited Settings menu 2 Select the menu item USER MANAGE jena i Settings 3 Press ADD to create a new user profile or EG ee EDIT to modify an existing profile e g to Adminis tr ator If Administrator change the password User name 4 Enter the following data for a new user User profile Password USER NAME user administration Password and password confirmation Confirm the password Selection of the user level USER LEV EL User tev Extended user N ote i By enabling the checkbox USER IS BLOCKED an User is blocked administrator can block an extended user profile 5 Acknowledge the entries with OK and exit the next screen also with OK Switchi
29. l ues too high Plausibility error temperature sen sor left Plausibility error temperature sen sor right Error heating system Timeout by communication Device Error Fault removal Permissible maximum current of a drive axis exceeded Max permissible difference between the two tempera ture sensor values exceeded Temperature value of the left or right temperature sensor not plausible Error in the heating system Timeout during the execution of an internal command of the user interface Generally displayed after all error messages in an ad ditional message window Notes on preventing errors Observe the following notes to prevent errors during the daily routine 1 After switching on the device automatically moves to its start position Any fluids still present in the tips after an abortion power failure are not discharged in the process In this case the fluid can be discharged using the tool EMPTYING TIPS in the TOOLS menu see section Checking and executing individual device functions with Tools p 35 2 Wait approx 30 s after switching on the InnuPure C16 for the device initialization to be completed which is indicated by a beeping sound Only then may the HID Pro 320 be operated or the sample tray be moved into the device Otherwise program faults may result 3 Before starting an extraction protocol or a device function make sure that no consuma bles from previous processes have remained in the dev
30. le The above mentioned components are not resistant to the following substances LJ hydrogen fluoride HF hydrofluoric E acid g LJ highly concentrated acids a LJ cleaning powder J Q paint thinner LJ naphtha 3 10 Behavior during emergencies E gasoline acetone cleaning spray ozone If there is no immediate danger of injury switch the device switch of the InnuPure C16 into the 0 position during dangerous situations or accidents when possible and or disconnect the mains plugs from the mains outlets Because a rapid response can save lives during an emergency the following has to be en sured Q The operating staff must be familiar with the location of safety equipment accident and danger alarms as well as first aid and rescue equipment as well as their han dling U The operator is responsible for the respective training of the operating staff LJ All equipment for first aid first aid kit eyewash bottles stretcher etc as well as equipment for firefighting fire extinguishers must be within reach and easy to ac cess All equipment has to be in a sound condition and should be checked regular InnuPure C16 ly Edition 09 2012 13 Safety instructions 3 11 14 Standards and directives The device was manufactured according to the currently valid technology regulations and the approved safety related regulations When constructing the device the relevant safety and health requirements of the app
31. less steel pistons Cleaning easy accessibility of system components through front door Temperature control heating up to 80 C Application parameter Consumables completely contained in the required kit sealed pre filled reagent strips or plates Lysis step automated in the device dependent on the source material Extraction routines pre installed protocols optimized for the most varied source materi als Piercing function removing the sealing film from the reagent strips and plates not nec essary Cross contamination completely precluded through sealed reagent strips and plates Tips max 32 per preparation with 1000 ul each Sample capacity up to 16 preparations in parallel processing of different source materials possible with identical pipet ting protocols Sample preparation pre insertion of the pipette tips samples and elution tubes into the sample tray insertion of pre filled reagent strips plates into the sample tray Other technical data Weight Approx 28 kg Dimensions 380 mm x 435 mm x 530 mm WxHxD InnuPure C16 Edition 09 2012 N Technical data Interference suppression Interference suppression in compliance with the rules BMPT electromagnetic compati Vig 243 1991 and EN 55022 class A bility Environmental conditions Temperature during 5 35 C operation Humidity during operation max 80 at 30 C Temperature during 10 55 C storage Humidity during storage max 80
32. licable laws standards and regulations were applied The safety of the device is confirmed by the CE mark and the declaration of conformity Information regarding safety corresponds to the currently valid regulations of the European Union In other countries the applicable laws and country specific regulations have to be complied with Besides the safety instructions in this user manual and the local safety regulations that apply to the operation of the device the general applicable regulations regarding accident preven tion occupational health and safety and environmental protection have to be observed and complied with References to potential dangers do not replace the work protection regulations which must be observed Edition 09 2012 InnuPure C16 4 1 4 2 InnuPure C16 Technical description Technical description Basic system design The InnuPure C16 is a flexible and efficient extraction system for the fully automated isola tion and purification of nucleic acid The system developed and produced in Germany has been designed for low sample throughput A large selection of different source materials can be used The system combines a unique technology for handling fluids with an extremely fast walk away principle The InnuPure C16 is equipped with pre installed extraction protocols to prevent time consuming programming The high degree of flexibility of the InnuPure C16 enables the par allel isolation of DNA and RNA fr
33. n LED strip This illuminates dependent on the operating state green or red or indicates the use of the touch sensor by alternating green red flashing Edition 09 2012 15 Technical description U QU le I a 3 c LED status indication Touch sensor 4 Control unit HID Pro 320 front door 1 5 2 sample tray adapter Figure 2 Front view of the InnuPure C16 p PLN TALET SEN ov ER RS 232 interface 4 Mains switch Fuse holder bridging switch of the touch sensor standby switch Type plate 5 6 Mains connection Figure 3 Rear connections and switches at the InnuPure C16 InnuPure C16 Edition 09 2012 16 Technical description 1 tip ejector 4 Drip tray 2 cones for accepting tips 5 magnet heating element only visible when 3 guide rails for the sample tray extracted Figure 4 Device view with open front door All pre manufactured reagent packs necessary for the extraction process including all buffer solutions the filter tips and the elution vessels are placed onto the sample tray Dependent on the number of samples reagent plates deep well plates with eight sample positions or reagent strips for individual samples will be used Thus within a single extraction protocol one sample in a reagent strip up to a maximum of 16 samples win two deep well plates can be processed Optionally available adapters are used to accept the reagent strips Reagent plates are placed
34. ng user login at Start on off The automatic user login at the start of the InnuPure C16 is a program default It can only be disabled by a user with administrator rights The function for disabling enabling is accessed via the MENU button in the top left corner of the start screen 1 Press the MENU button Edition 09 2012 37 Operation 6 3 6 38 2 Inthe menu displayed disable the function LOGIN AT START if no login prompt is to be shown when starting the InnuPure C16 At the next program start the last logged in user is automatically logged in Logging in a different user Whilst working in the program of the InnuPure C16 a different user can be logged in The change of login is affected via the MENU button in the top left corner of the start screen 1 Press the MENU button 2 Select the menu item NEW LOGIN 3 Enter the new user name and corresponding password and confirm your entries with OK Switching the interior light on and enabling the touch sensor The interior of the InnuPure C16 is illuminated during the processing of an extraction proto col However the illumination can also be switched on and off separately During the pro cessing of an extraction protocol the touch sensor is disabled to prevent the device from accidentally being switched off If a running protocol is aborted using the STOP button or on account of an error the touch sensor remains disabled and must be switched back on if re quir
35. nnn 23 Switching on the InnuPure C16 arrrnanrnnnnrnnnnvnnnnnvnnrnnanennnnennnnnnnnnnnnnennanennnnennn 23 Switching off the InnuPure C16 arrrnanrnnanennnnrnnnnnnnnrnnanrnnnnennnnnnnnnnnnnrnnanennnnennn 24 Switching off the touch sensor cccccescccseeceececeueeceueeceeeceeessueessueeseeeeeeeeeaas 24 SRO Maa aaa EE EE 25 6 1 Preparation of the buffers and solutions 0022000220022n0 nenne nenn nennen 25 6 2 Preparing the sample trays and inserting them into the InnuPure C16 25 6 3 Operating InnuPure with HID Pro 320 rrrronrrnrnnnrnnnrnrvnnnenrnnnennnnnennnnnnnnnnennnnne 29 6 3 1 Overview of the InnuPure C16 program rrnrrnnnrnranrnranennnnernnnnnnnnnnanenvanennnnennn 29 Edition 09 2012 1 Contents 10 11 6 3 2 Starting an extraction PrOtOCOl ce cceeccceccceeeceeeeceeeeseeeeaeeseeeeseeeeseeesseeesaeeees 30 6 3 3 Copying moving or deleting extraction ProtocolS rrrrrrrrrrrrnnrnranrrnanennnnennnnnn 33 6 3 4 Checking and executing individual device functions with Tools 35 6 3 5 Work with user ID management rrnnnnnnnnnnnnnnnnnnnnnnnnnrrnnnnennnnrennnnrennnsrnnnnsennnnsen 36 GST IQS Se RE een ee 36 Creating modifying a user profile uu00244400Rnennne nennen nennen nennen nnennneenenn 36 Switching user login at Start ON off uuu404400444ne nenne nnnnn nenne nenne nnenne nennen 37 LOGGING In a
36. olding position Ww Ww Tip washing To prevent the carry over of washing solution residue the tips used are flushed between specific washing steps Removal of the washing solution from the 1st work Change of the work cavity cavity Prior to the final washing step the washing solution is removed completely from the 1st p work cavity and transferred by pipetting over WT into the 4th work cavity VPN wv The quality of the already washed nucleic acids is significantly improved by the transfer into a clean work cavity Any lysis residue at Discharge of the washing solution into the 4th work the walls are retained in the dirty cavity and cavity only the already washed nucleic acids bound to the magnetic particles are transferred on 2 Ethanol removal NEE The removal of ethanol residue at the mag zn netic particles and within the samples takes EN place via a drying step In this step a heating is activated in the cavity floor causing the ethanol residue to evaporate 20 Edition 09 2012 InnuPure C16 Technical description Transfer of the elution buffer into the work cavity Elution The elution volume can be adjusted in the range from 100 to 500 ul and is defined at a the start of the protocol WT NNN Heating of the elution buffer The corres
37. om up to 16 samples The work intensive process of sample lysis which so far mostly had to be performed separately now is part of the automatic extrac tion process dependent on the source material The nucleic acids to be isolated adsorb at surface functionalized magnetic particles The necessary extraction chemicals are added manually as necessary and enable the purifica tion of ultrapure nucleic acids with excellent yields The extraction principle prevents cross contamination effectively a problem often occurring in vacuum based extraction methods The isolated nucleic acids can then be used immedi ately for further downstream applications Different specifically optimized extraction kits are available for the InnuPure C16 LJ for the isolation of genomic DNA LI for cellular RNA LJ for viral or bacterial nucleic acids LJ for the processing of forensic samples Dependent on the application the extractions take between 45 and 75 minutes Design connections indications The InnuPure C16 is a stand alone device The operation and device control take place via the control unit HID Pro 320 attached to the front The sample processing follows pre installed protocols tailored to the extraction kits The kits include all reagents necessary for extraction permitting the extraction to run fully automated During operation the front door of the InnuPure C16 is closed For the status control of the device the touch sensor has been equipped with a
38. op of it 12 Place the mains plug onto the card board cover as shown Note If you send the InnuPure C16 to Analytik Jena AG complete the decontamination description and place it together with an error description into the cardbox Transport notes Observe the safety instructions in chapter Safety instructions transport and installation p 11 Transport the InnuPure C16 very carefully to prevent damage from impact or vibration The InnuPure C16 should be transported in such a way that major temperature fluctuations are avoided and the formation of condensate is thus prevented Moving the device in the laboratory CAUTION Unintentional dropping of the InnuPure C16 creates a risk of injury and damage to the mod ule Move the InnuPure C16 with great care 2 persons are required to lift and carry the device When moving the InnuPure C16 in the laboratory observe the following LJ Insert the sample tray and start the tool TRANSPORTATION LOCK IN TIPLINE 1 This moves the cones into the tip row 1 of the sample tray and arrests the axes for a short transport LJ Switch off the device and disconnect the mains connection Remove the HID Pro 320 from the device LJ To prevent health damage the following must be observed when moving the device in the laboratory lifting and carrying For reasons of safety 2 persons are required to transport the device and must position themselves on both sides of the equipment
39. ox 30 s The end of initialization is signaled by a beeping sound Only then may en tries be made via the control unit HID Pro 320 Edition 09 2012 23 First commissioning 3 Enter the following password User name Administrator Password IPC16 v The InnuPure C16 is now ready for operation Note User administration is enabled using the menu item MENU LOGIN AT START Disable the command if you do not want to use user administration This requires administrator rights At the next device start the last logged in user is automatically logged in Select a Mew Sea ENG Life Science unlimited Figure 8 Start window Switching off the InnuPure C16 Wait until all processes of the current extraction protocol have completed Then switch the InnuPure C16 off from the mains switch at the equipment backplate Alternatively you can put the InnuPure C16 into sleep mode To this end touch the touch sensor for approx 3 s until it illuminates red and the indication at the control unit HID Pro 320 goes out Note During sleep mode the InnuPure C16 is not switched off completely but consumes power To switch off the InnuPure C16 completely switch off the device from the mains switch at the equipment backplate Switching off the touch sensor The touch sensor can be bypassed Then the device can no longer be switched on and off from this switch If you do not want to use the touch sensor move the switch 5 in Figure
40. ple tray once it is being pulled in Otherwise there is a risk of your hand being crushed 12 Start the extraction protocol Inthe start window press the button SELECT PROTOCOL Select the desired extraction protocol and press START see chapter Starting an extraction protocol p 30 13 After completion of the protocol press again lightly against the tip block The sample tray is then automatically moved out of the sample block InnuPure C16 Edition 09 2012 27 Operation 14 Remove the sample tray from the adapter of the InnuPure and move it back into the priming station 15 Close the elution vessels PAIN IMPORTANT Load the sample tray evenly For an extraction protocol both adapters in the sample tray must be filled in order to be bal anced and to allow for optimum movement of the tray inside the device to the necessary positions LJ If more than one reagent strip are processed during the extraction protocol insert two adapters into the tray and distribute the strips evenly between them LI If only one sample is extracted then place an adapter with an empty strip onto the second adapter in the sample tray LI If you process the samples in a reagent plate populate the second adapter with an empty plate 28 Edition 09 2012 InnuPure C16 Operation 6 3 Operating InnuPure with HID Pro 320 Device control is via the HID Pro 320 unit After switching on the InnuPure C16 a de
41. pondingly selected volume is re moved from the holding position and trans ferred to the magnetic particles in the work 85 g i q cavity wy hA Elution and collection of the magnetic particles The elution process represents the separat ing of the nucleic acids from the magnetic ue o ve particles This is improved by heating the elution buffer and mixing well through pipet VW WT WNT ting on and off Change of the work cavity To be able to transfer the eluates free from magnetic particles into the elution vessels the eluate is transferred once again into a new work cavity There the remaining magnetic TM Wye particles are finally collected at the cavity floor Eluate transfer m ser 1 The nucleic acids are now extracted are ss w transferred into the elution tube and are available for further downstream applications Note Filling levels and filling colors are only shown for illustration and do not match the actual filling levels and colors of the kit reagents InnuPure C16 Edition 09 2012 21 First commissioning 5 5 1 5 1 1 5 1 2 22 First commissioning Site requirements Installation conditions The following requirements are placed on the climatic conditions in the operating room of the InnuPure C16 Q Temperature range 5 C to 35 C LJ Max humidity 80 at
42. r extension of the device or its repair The device must only be operated if all protective equipment e g doors are pre sent properly installed and fully operational Free access to the device switch on the back of the enclosure must be ensured during operation During operation and immediately after aborting an extraction protocol the operator must not reach with his hands into the device chamber Otherwise the operator may get burned at the magnet heating adapters max 80 C After aborting an ex traction protocol it is necessary to wait 5 min before performing additional tasks in side the device The ventilation equipment on the device must be in good working condition Cov ered vents or ventilation slits etc may cause the device to break down or may cause damage to it The mains plug must only be plugged into a power outlet with protective ground connection The device may only be connected to power sources whose nominal voltage is the same as that on the nameplate of the equipment The protective ef fect must not be invalidated by the use of an extension line which does not have a protective conductor Do not introduce any objects into the device and prevent fluids from entering the device through openings or gaps Do not short circuit the device and only use fuses in accordance with the specifica tions in the technical data 3 8 Handling hazardous substances Even with intended use there is a risk of health damage
43. r the nucleic acids are bound to the magnetic particles Dependent on the protocol sequence with external or internal lysis the binding of the nucleic acids takes place in different posi tions of the reagent structure In the external lysis the mix of lysed sample and MAG suspension is first homogenized by pipetting on and off The binding buffer is then transferred to the sample During the next step the magnetic unit is moved to the floor of the work cavity The magnetic particles with the bound nucleic acids are held by the magnetic field on the floor of the work cavity The excess of binding buffer is transferred to the original holding position by pipetting off Technical description Washing buffer transfer Washing of the nucleic acids The magnetic particles remain in the work cavity and the washing buffer is then trans ferred there By pipetting different washing Nr AG buffers on and off the nucleic acids are washed Washing The number of washing steps and volume and type of washing buffer depend on the TT type of the source material used In addition Beck the buffers differ in the case of DNA or RNA v NE h extraction Collection of the magnetic particles and transfer of the Between each washing step the magnetic excess particles are collected with the bound nucleic acids from the cavity floor The correspond ing wash excesses are pipetted off and re TE p ag turned to their original h
44. rity prompt Wait with further operations until the cop ying process has completed and the message PROCESS FINISHED is dis played This may take up to 20 s per pro tocol During this time the device cannot be operated Acknowledge the comple tion of the copying process with OK Load protocol After completed copying go back to the data carrier CARD and make sure that the Blood midi C16 01 j Blood_mici_C16_ protocols have been copied O Blood mini C16 01 O DNA external Lysis 015 01 Plant DNA 016 01 virus C16 01 Edit EEE Select Start Load protocol 10 Press SELECT again Blood_midi_c16_04 v This concludes the copying pro Hk cess and the START button be ie ition J comes available again The ex traction protocol can now be Plant DNA C16 01 started virus C16 01 N ote Only remove the USB stick after the device has been switched off Otherwise the USB DMA external _Lysis_C16_01 34 Edition 09 2012 InnuPure C16 Operation 6 3 4 Checking and executing individual device functions with Tools Individual device functions can be executed in the TOOLS menu Using these tools the filter tips can e g be emptied and removed from the device after aborting an extraction protocol In the start window press the button TOOLS Select a Tools menu 2 Select the tool for a device function and press START Emptying tips n cavity 31 Heat test Initialization Protocol wzp
45. rrnnnnanoranenanennnenanennnnnnr 9 3 3 Safety marking at the InnuPure C16 rrranrrnnnnennnnonnnrnnnnrrnanennnnnnnnnnnnnrnnanennnnennn 10 34 TOCAAIGAl CONGITION kseronina a a a N 11 3 5 Requirements for the operating personnel cccceeceseeecaeeeeaeeeeeeeeseeeeseeeeaes 11 3 6 Safety instructions transport and installation u2 202220222022neenn 11 3 7 Safety instructions operation 2 uz0020000000nnennnnno neuen neuen nnnnnnnnnnnennnnnennnnnenn 12 3 8 Handling hazardous Substances uuu224sssnennennennennnnne nenne nenne nenne nnnnne nennen 12 3 9 Chemical resistance of the device z0220000020000nenen neuen neuen nnnnnn nennen nennen 13 3 10 Behavior during emergencies 0000000000000nennnonnnnn neuen nnnnnnnnnnnnnnnnne nennen 13 3 11 standards and direelives u ieee ees 14 BECHNICaAL GESCHPLON u ee encoun 15 4 1 Basic system ESN 15 4 2 Design connections indications rranrrnnrrnnrnnnnvnnnrnannnnnnvanevanenanevanenanenanennnennee 15 4 3 Picple or oreralNa nee NNN 19 FIrSE COMMISSIONING au san ee ee ehe 22 9 1 SllETEequiremenlsz eier REN 22 Sila Installation CONANONS iis anne 22 51 2 SPACE rede EN NNN 22 SD BIEN SUNT 23 5 2 Connecting the InnuPure C16 and switching it on off rrrrnnnnnnnrrnrnnrrnrnnnennnn 23 Connecting the InnuPure C16 rrrarrnnnnrnnnnrnnnnrnnnnnnnnrnnanrnnanennnnnnnnnnnnnsnnanennnne
46. t the isolation protocols can be transferred and a simple software update is also possible 1 interface to connect to the InnuPure 3 USB port 2 network connection Figure 7 HID Pro 320 Edition 09 2012 InnuPure C16 4 3 Principle of operation Pre filled reagent structure mm Magnetic Beads Washing Solution Lysis Solution Water me Binding Solution Elution Buffer External lysis U Internal lysis ue Mixing of lysate magnetic particles 00 w v W ge Mixing of sample and binding buffer Du Collection of the magnetic particles and transfer of the EXCESS InnuPure C16 vu we p Edition 09 2012 Technical description Reagent structure The reagent strips or reagent plates are completely pre filled and contain in addition to the magnetic particles all reagents neces sary for the extraction process for the bind ing washing and elution of nucleic acids After starting an extraction protocol the In nuPure C16 takes the tips provided from the corresponding row in the tip block of the sample tray Lysis Dependent on the type of source material the lysis is processed either inside the device internal or must be performed manually outside the device external The lysis step for the corresponding source material has been described in detail in the manual for the respective extraction kit Binding With the aid of the binding buffe
47. tool see item 8 For the strips position 1 is at the tab labeled AJ On the plates the po sition numbers are attached on the side Caution Open the cavities fully at least 7 mm in diameter The used filter tips are ejected into these cavities during the extraction protocol If the cavities are closed or insufficiently opened the tips may be thrown out of the cavities after ejection due to travel This may result in errors during the extraction process and in adverse cases even a cancellation of the protocol 8 When using the perforation tool place it onto the edges of the rear holding down clamp with the four long bolts sitting against the edges Then press the tool down until the stop to make the tips pierce through the sealing film and creating large openings The use of the tool is iden tical for reagent plates and strips 9 Continue preparing the reagent strips and plates in accordance with the kit descrip tions 10 Switch on the InnuPure C16 and wait for the device initialization to complete which is signaled by a beeping sound 11 Move the loaded sample tray with the reagent strips forward into the adapt er on the front of the InnuPure The serrated rails at the side of the sam ple tray must protrude into the grooves of the adapter After press ing lightly against the tip block the sample tray is automatically pulled in to the device CAUTION Risk of crushing A Immediately let go of the sam
48. umables that are not recommended for the InnnuPure C16 and the cor responding kits to use overfilled consumables The operator is responsible for the use of the equipment as intended Warranty and liability The warranty duration and liability comply with the legal requirements and the provisions in the general terms and conditions of Analytik Jena AG Deviations from the intended use described in this user manual result in limitations of war ranty and liability during a damage event Damage to wearing parts is not included in the warranty Warranty and liability claims are excluded for personal injury and property damage due to one or several of the following causes Q DODO DODO use of the InnuPure C16 other than intended improper commissioning operation and service of the device modifications of the equipment without prior consultation with Analytik Jena AG unauthorized intervention in the equipment operation of the device with faulty safety equipment or improperly fitted safety and protection equipment inadequate monitoring of the equipment components subject to wear use of other than original spare parts wearing parts or consumables improper repairs faults due to the non observance of this user manual Edition 09 2012 InnuPure C16 Technical data 2 Technical data Device operation stand alone via HID Pro 320 with 5 7 touchscreen color Maintenance maintenance free through the use of non wearing stain
49. upwards InnuPure C16 Edition 09 2012 25 Operation Place the reagent plate into the hold er of the sample tray The red line on the cover film must point to the red dot at the holder Place the adapter for the reagent Strips into the holder Here too the red marking on the adapter must point to the red point at the holder Caution Load the sample tray evenly in both adapters see below Place the strips into the adapter The long tab marked with the label AJ must point to the engraved numbers on the sample tray Fold down the holding down clamp to prevent the plates and strips to be pulled out of the holder during the ex traction process Place the filter tips into the two rows with the smaller drill holes Place the elution vessels into the wider drill hole at the edge of the tip block Empty sample positions do not need to be filled Especially with the strips make sure that for every strip the tips and the elution vessel are in the cor responding positions in the tip block arrows in figure on the left 26 Edition 09 2012 InnuPure C16 Operation Caution The number of filter tips per sample and their positioning 1st or 2nd row in the tip block depends on the rea gent kit used Pay attention to the kit description 7 Open all cavities of positions 1 and 3 on the strips and plates by piercing the film with an unused filter tip and widening it or using the optionally available perforation
50. vice initialization lasting approx 30 s is automatically performed testing various device functions and moving the electro mechanical drives into their start positions The completion of initiali zation is signaled by a beeping sound Only then may entries be made in the HID Pro 320 unit 6 3 1 Overview of the InnuPure C16 program All program functions are easily accessible via the start window Mew login w Login at start Service mode Blood midi 016 01 Blood mini 016 01 DNA external Lysis CE Plant DA 016 01 virus C16 01 Settings menu Emptying tips in cavity 31 Heat test Initialization Magnet test Transport lock fin tipline 1 Traw out Life Science unlimited 1 Menu with functions for user administration and 4 Starting tools to execute individual device for exiting the InnuPure C16 program functions 2 Time and date configuration 5 General settings 3 Starting loading and deleting extraction 6 Version information protocols Figure 9 Program overview of the InnuPure C16 InnuPure C16 Edition 09 2012 29 Operation 6 3 2 30 Using the MENU 1 button in the top left corner you open a menu with the functions for dis abling the user login when switching on the InnuPure C16 and for changing user logins see chapter Work with user ID management p 36 A user logged in with administrator rights can leave the program with EXIT and arrives at the operating system of the HID Pro 320 pass
51. when handling hazardous substanc es The operator is solely responsible for the compliance with all safety requirements to pro tect individuals and property when handling radioactive infectious toxic caustic flammable and other hazardous substances E 12 Control the handling of hazardous substances in accordance with the safety cate gory of the lab the details in the manufacturer safety data sheets and additional national and international regulations WHO Laboratory Biosafety Manual Wear personal protective equipment when working at the device Observe all notices on the cleaning and decontamination of the device Edition 09 2012 InnuPure C16 3 9 Chemical resistance of the device Safety instructions Aggressive substances may damage the device Although the materials used are resistant to most commonly use substances material damage from aggressive substances may not be precluded E Before using aggressive substances e g acids bases or organic solutions check whether the materials in direct contact with the substances are resistant to them LJ Only use substances compatible with the materials listed Aluminum stainless steel PTFE rubber NBR 70 The pistons are not contaminated with sample if the filter tips LJ If in doubt contact Analytik Jena AG Components Material Filter tips PP Piston seal are used Reagent cups PP or PTFE Overview 1 Components and materials in direct contact with the samp
52. word ipex The SERVICE MODE is only accessible to service staff Hidden behind the clock symbol ul 2 in top right corner there is a window for configuring the date and time of the InnuPure C16 program see chapter Configuring the time p 39 Using the SELECT PROTOCOL button 3 you select an installed extraction program and start it see chapter Starting an extraction protocol p 30 A user with administrator rights can also install additional extraction protocols in this window and delete unnecessary protocols see chapter Copying moving or deleting extraction protocols p 33 Via TOOLS 4 you start programs for testing or executing individual device functions e g the control of the heating function or the ejection of the filter tips With SETTINGS 5 you gain access to the following program functions Q User administration Creating modifying a user profile p 36 LI Device functions Switching the interior light on and enabling the touch sensor p 38 Q Language selection currently only English LJ Software update Software update p 44 Information about the installed software version is available in the SETTINGS MENU via the HELP button 6 Starting an extraction protocol 1 Press the SELECT PROTOCOL BUTTON Select protocol Life Science unlimited settings 2 Select the desired protocol from the list Load protocol 3 Press the START button Blood midi 16 01
Download Pdf Manuals
Related Search