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Safety instructions

14

Edition 06/2015

InnuPure C16

3.11

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 applicable
laws, standards and regulations were applied. The safety of the device is confirmed by the
CE mark and the declaration of conformity.

All the information regarding safety corresponds to the currently valid regulations of the Eu-
ropean Union. In other countries, the applicable laws and country specific regulations have
to be complied with.

Besides the safety instructions contained in this user manual and the local safety regulations
that apply to the operation of the device, the general applicable regulations regarding acci-
dent prevention, 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.

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Содержание InnuPure C16

Страница 1: ...InnuPure C16 Extraction system Operating manual...

Страница 2: ...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...

Страница 3: ...the device 13 3 10 Behavior during emergencies 13 3 11 Standards and directives 14 4 Technical description 15 4 1 Basic system design 15 4 2 Design connections indications 15 4 3 Principle of operatio...

Страница 4: ...B stick 42 Viewing logfiles 42 6 3 7 Working with user management 44 User rights 44 Creating changing deleting a user profile 45 Switching user login at start on off 46 Logging in a different user 46...

Страница 5: ...ing station and optionally available perforation tool 18 Figure 7 HID Pro 320 18 Figure 8 Start window 24 Figure 9 Program overview of the InnuPure C16 29 Figure 10 Assignment of the sample positions...

Страница 6: ...Figures 4 Edition 06 2015 InnuPure C16...

Страница 7: ...the dan ger The meaning of the pictographs and signal words used is explained in the chapter Safety notes The elements of the control program are indicated as follows Program terms are identified with...

Страница 8: ...ility in the event of a claim Damage to wearing parts or breakage of glass are not included in the warranty Warranty and liability claims are excluded for personal injury and property damage due to on...

Страница 9: ...ed through sealed reagent strips and plates Tips max 32 per preparation each with a capacity of 1000 l Samples Sample capacity up to 16 preparations in parallel processing of different source material...

Страница 10: ...PC interface USB Interference suppres sion electromagnetic compatibility interference suppression in compliance with the requirements of BMPT Vfg 243 1991 and EN 55022 Class A Environmental conditions...

Страница 11: ...nal 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 3 2 Symbo...

Страница 12: ...ts Biological hazard Warning against damage from biological sub stances Observe the corresponding protection instructions Reaching inside the de vice prohibited during operation Warning against crushi...

Страница 13: ...gs or medication is not permitted It must be ensured that only authorized personnel works at the device The operating personnel must be familiar with the dangers arising from the sub stances used Appr...

Страница 14: ...round 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...

Страница 15: ...wing substances Hydrogen fluoride HF hydrofluoric acid Highly concentrated acids Cleaning powder Paint thinner Naphtha Gasoline Acetone Cleaning spray Ozone Salt containing detergent NaCIO sodium hypo...

Страница 16: ...f conformity All the information regarding safety corresponds to the currently valid regulations of the Eu ropean Union In other countries the applicable laws and country specific regulations have to...

Страница 17: ...ure nucleic acids with excellent yields The extraction principle effectively prevents cross contamination a problem often occurring in vacuum based extraction methods The isolated nucleic acids can th...

Страница 18: ...3 Sample tray adapter 4 LED status indication 5 Touch sensor Figure 2 Front view of the InnuPure C16 1 Mains switch 2 Fuse holder 3 Mains connection 4 RS 232 interface 5 Bridging switch of the touch...

Страница 19: ...available adapters are used to accept the reagent strips Reagent plates are placed directly into the sample tray For populating the sample tray the tray must be placed into the priming station suppli...

Страница 20: ...hus the entire system be comes a stand alone device For the review of the running extraction the status of the cur rent step is displayed in real time The user can thus follow every routine clearly an...

Страница 21: ...the respective extraction kit Mixing of lysate magnetic particles Transfer of binding buffer to the sample Mixing of sample and binding buffer Collection of the magnetic particles and transfer of the...

Страница 22: ...olding position 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 cavity Disc...

Страница 23: ...The elution process represents the separat ing of the nucleic acids from the magnetic particles This is improved by heating the elution buffer and mixing well through pipet ting on and off To be able...

Страница 24: ...for air conditioning Never cover the front door or the ventilation slits of the device with other equipment or installations Keep a safety distance of at least 5 cm from the rear of the device to oth...

Страница 25: ...ess 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 The InnuPure C16 is now ready for operation Switc...

Страница 26: ...Alternatively you can put the InnuPure C16 into sleep mode To do so touch the touch sen sor for approx 3 s until the status indication currently flashing green red changes to red only and the indicat...

Страница 27: ...preheat the thermal mixer for some steps of the lysis in ac cordance with the kit manual 6 2 Preparing the sample tray and inserting it into the InnuPure C16 CAUTION Nickel allergy The sample tray is...

Страница 28: ...to the holder The red mark ing on the adapter must also point to the red point at the holder here Caution Load the sample tray evenly in both adapters see below 4 Place the strips into the adapter The...

Страница 29: ...ers are attached on the side ATTENTION 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...

Страница 30: ...nfirming the Protocol End step by means of the NEXT but ton After the tray moves out of the device the protocol is automatically closed To remove the tray press lightly against the tip block The sampl...

Страница 31: ...tions takes place The end of initialization is signaled by a beeping sound Only then may entries be made via the control unit HID Pro 320 6 3 1 Overview of the InnuPure C16 program All program functio...

Страница 32: ...s window and delete un necessary protocols see chapter Copying moving or deleting extraction protocols p 34 Via TOOLS 4 you can start programs for testing or executing individual device functions e g...

Страница 33: ...e status line of the window in accordance with the inputs and confirm the query with OK Press CAN CEL to cancel the protocol if the volume shown does not meet your requirements In this case restart th...

Страница 34: ...and inserting them into the InnuPure C16 p 25 and then confirm the message with OK Se lect CANCEL if you want to cancel the protocol 8 This is followed by tray calibration The status line displays a b...

Страница 35: ...rotocol 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 11 After completion of the entire protocol the tray remain...

Страница 36: ...ng the protocol folders to be copied or to which protocol folders from the SD memory card of the HID Pro 320 are moved In the example copying a protocol DNA_internal_Lysis_FAST_C16 to the SD memory ca...

Страница 37: ...ions until the message disappears and the copying pro cess has been completed This may take up to 20 s per protocol During this time the device cannot be operated At the end of the copying process con...

Страница 38: ...vice functions can be executed and checked in the TOOLS menu Using these tools the filter tips can for example be emptied or ejected and the tray removed from the device after aborting an extraction p...

Страница 39: ...on of using a sample setup tool is provided at the beginning of each extraction pro tocol started via the HID Pro control unit see also chapter Starting and executing an extrac tion protocol p 30 This...

Страница 40: ...y is populated with samples This also enables the corresponding text fields The text fields appear orange until a sample name is assigned 3 Select the text field for a sample position and enter its na...

Страница 41: ...ol at any time with CLOSE In this case an empty setup is stored in the logfile with the information that the tool was closed with out any transfer of data Creating a sample setup via an external PC IM...

Страница 42: ...setup should now look as follows note that the display has been highlighted to allow the necessary spaces to be recognized more easily Figure 11 Empty sample setup in the PC program 3 Now add the des...

Страница 43: ...possible to recognize or open the setup An example of a completed setup with the sample configuration from section Creating and saving a sample setup via the HID Pro 320 p 37 Figure 12 Sample setup cr...

Страница 44: ...e contents of logfiles can be viewed on a computer with a text editor installed The files are transferred to the computer via a USB stick 1 Exit the start screen of the InnuPure C16 program Press the...

Страница 45: ...C16 Edition 06 2015 43 Figure 13 Example logfile of a demo protocol run The following data is stored in the logfile Date of execution Logged in user installed software version installed firmware vers...

Страница 46: ...tor User rights User management allows the creation of two types of users Administrator and Extended user They have the following rights Action Administrator Extended user Execute protocols Execute to...

Страница 47: ...er profile or EDIT to change an existing profile e g to change the password Note After confirming the confirmation message an administrator can delete another user profile with button DEL The standard...

Страница 48: ...reen 2 Select the menu item NEW LOGIN 3 Enter the new user name and the corresponding password and confirm your entries with OK 6 3 8 Enabling the interior light and the touch sensor The interior of t...

Страница 49: ...he date and time of the InnuPure C16 are configured via the clock symbol in the top right corner of the start screen 1 Press the clock symbol in the start window 2 Set the date and time and confirm yo...

Страница 50: ...of Analytik Jena AG 7 1 Error messages Possible error message Meaning Command incorrect Internal command incorrect incomplete Slave response incorrect Response from 2nd control incorrect incomplete C...

Страница 51: ...id can be discharged using the tool EMPTYING_TIPS in the TOOLS menu see the section Checking and executing individual device functions with tools p 36 2 Wait approx 30 s after switching on the InnuPur...

Страница 52: ...e user interface is possible after an abortion by pressing the x symbol top right in the window During the tip ejection step applicable to all extraction protocols tools it is not possible to abort th...

Страница 53: ...of infectious material great care must be taken because the InnuPure C16 cannot be decontaminated as a whole device Visible contamination must be removed immediately using suitable detergents making s...

Страница 54: ...rvice a prior decon tamination must be carried out and documented see the documents in the product folder 8 2 Changing fuses CAUTION Electric shock Disconnect the mains plug before changing fuses If t...

Страница 55: ...witch on the InnuPure C16 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 In the main men...

Страница 56: ...wide side walls and a lit The parts of the box are connected with clamps to each other which are pressed into the slits on the edges of the walls The clamps have a longer and a shorter side and can on...

Страница 57: ...disconnect the mains plug from the InnuPure C16 3 Insert the sample tray 1 the priming station 2 and the adapters for rea gent strips 3 optional into the spac es in the accessory box provided 4 Place...

Страница 58: ...ft the device and must position themselves on both sides of the equipment Grip the de vice firmly with both hands at the lower end lifting it simultaneously Make sure the door is closed Do not use the...

Страница 59: ...tructions in the chapter Safety instructions transport and installation p 11 Avoid the following during transport Shocks and vibrations Risk of damage from jolts shocks or vibrations Large fluctuation...

Страница 60: ...simultaneously Observe the guide values and adhere to the legally mandated limits for lifting and carrying without auxiliary means For the setup at the new location observe the notes in the section Si...

Страница 61: ...dition 06 2015 59 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 regulati...

Страница 62: ...EC Declaration of Conformity 60 Edition 06 2015 InnuPure C16 11 EC Declaration of Conformity...

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