Analytik Jena qTOWER3 G IVD Operating Manual
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Analytik Jena qTOWER3 G IVD Operating Manual

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Operating Manual
qTOWER
G IVD
3
For in-vitro diagnostics

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Summary of Contents for Analytik Jena qTOWER3 G IVD

  • Page 1 Operating Manual qTOWER G IVD For in-vitro diagnostics...
  • Page 2 Microsoft and Windows are registered trademarks of Microsoft Corp. Copyrights and The identification with ® or TM is omitted in this manual. Trademarks 10-3107-022-23 Documentation number A (01/2021) Edition Analytik Jena GmbH Implementation of the Technical Documentation Copyright 2021, Analytik Jena GmbH...

  • Page 3: Table Of Contents

    qTOWER G IVD Contents Contents Basic Information ....................... 5 Notes on the manual ......................5 Intended use ........................7 Warranty and liability ....................... 8 Safety instructions ...................... 9 Safety symbols on the qTOWER³ G IVD ................9 Technical condition ......................9 Requirements for the operating personnel ..............
  • Page 4 Contents qTOWER G IVD Figures Fig. 1 Layout of the qTOWER³ G IVD ................15 Fig. 2 Schematic structure of the Epi fluorescence photometer ....... 16 Fig. 3 qTOWER³ G IVD front view ................19 Fig. 4 qTOWER³ G IVD, open ..................19 Fig.

  • Page 5: Basic Information

    qTOWER G IVD Basic Information Basic Information Notes on the manual The operating manual describes the following model of the qTOWER series:  qTOWER G IVD The qTOWER³ G IVD is intended for operation by qualified specialist personnel observ- ing this operating manual. The manual informs about the design and function of the unit and provides personnel familiar with PCR (Polymerase Chain Reaction) technology with the necessary know- how for the safe handling of the equipment.
  • Page 6 Basic Information qTOWER G IVD NOTICE Indicates a potentially hazardous situation which might cause material or environmen- tal damage. In this manual, on the product itself, and on the packaging, the following symbols are used to present important information to the customer, regardless of which language they speak.

  • Page 7: Intended Use

    The qTOWER³ G IVD is intended for in-vitro diagnostic examinations in combination with the use of IVD kits, which Analytik Jena (Jena site, Konrad-Zuse-Str. 1, 07745 Jena) designated and introduced for in-vitro diagnostic purposes (as specified in the designation of the corresponding IVD kit) and use with the qTOWER³...

  • Page 8: Warranty And Liability

     use of the qTOWER³ G IVD other than intended  improper commissioning, operation and servicing of the device  modifications of the equipment without prior consultation with Analytik Jena  unauthorized intervention in the equipment  operation of the device with faulty safety equipment ...

  • Page 9: Safety Instructions

    qTOWER G IVD Safety instructions Safety instructions Safety symbols on the qTOWER³ G IVD The qTOWER³ G IVD is fitted with safety symbols, the content of which must always be observed. Damaged or missing safety symbols can cause incorrect actions leading to personal injury or material damage! The safety symbols must not be removed! Dam- aged safety symbols must be replaced without delay! The following safety symbols are attached to the qTOWER³...

  • Page 10: Requirements For The Operating Personnel

     The operator must decontaminate the device if the housing or the sample block were contaminated with hazardous substances. For suitable disinfection agents and procedures see "Disinfecting the device" p. 27. Other disinfection agents that are not included in the list shall only be used after consultation with Analytik Jena.

  • Page 11: Safety Instructions, Transport And Installation

    The guide values and statutory limits for lifting and carrying loads without aux-  iliary equipment must be observed and adhered to. The qTOWER³ G IVD can be installed by the Analytik Jena customer service or trained specialist personnel authorized by Analytik Jena. Safety instructions - operation 2.5.1...

  • Page 12: Safety Instructions - Protection Against Explosion And Fire

    Observe the following:  Any work on the interior of the device may only be carried out by the customer service of Analytik Jena and specially authorized technicians.  The exterior electrical components must be checked regularly by a qualified electri- cian.

  • Page 13: Handling Of Samples, Auxiliary And Operating Materials

    qTOWER G IVD Safety instructions  Before opening the device it must be switched off from the power switch and the mains connector must be disconnected from the mains outlet!  The qTOWER³ G IVD must be switched off immediately using the power switch and the power supply disconnected from the mains if there is any interference with the electric components.

  • Page 14: Safety Instructions - Service And Repair

    Safety instructions - service and repair On principle, maintenance of the qTOWER³ G IVD is performed by the customer service department of Analytik Jena or its authorized and trained specialist personnel. Unau- thorized maintenance can damage the device. Therefore, the operator may generally only carry out the tasks listed in chapter "Maintenance and care"...

  • Page 15: Function And Setup

    qTOWER G IVD Function and setup Function and setup The qTOWER³ G IVD combines a PCR thermocycler with a patented fluorescence pho- tometer. Upper part with fluorescence photometer Heated lid Sample block Thermal cycler Fig. 1 Layout of the qTOWER³ G IVD Fluorescence spectrometer An 8-channel Epi fluorescence photometer with fiber-multiplexer and mechanical scanning device is used as detector.

  • Page 16: Pcr Thermocycler

    This can be adjusted up to 110 °C and guarantees an optimum contact pressure on the sample vessels during the entire real-time PCR run process. For in-vitro diagnostics, use the detection reagents and plastic products Analytik Jena or AJ Roboscreen GmbH specified for the corresponding qTOWER...

  • Page 17: Commissioning

    qTOWER G IVD Commissioning Commissioning Prior to commissioning, check that all requirements are fulfilled at the installation location (see section "Installation conditions" p. 17). Installation conditions 4.1.1 Environmental conditions The following requirements are placed on the climatic conditions in the operating room of the qTOWER³...

  • Page 18: Space Requirement

    Commissioning qTOWER G IVD Switching-on conditions Energy supply Operating voltage 100 V, 115 V, 230 V Line frequency 50 – 60 Hz Power consumption max. 850 W Instrument fuses Mains voltage Instrument fuses 100 V, 115 V, 230 V 2 x 10 AT / 250 V 4.1.3 Space requirement NOTICE...

  • Page 19: Connections And Control Elements

    qTOWER G IVD Commissioning Connections and control elements Upper part with fluorescence- spectrometer Lock with handle LED for status display Lower part with thermal cycler Fig. 3 qTOWER³ G IVD front view Heated lid Sample block Twistlock Fig. 4 qTOWER³ G IVD, open The qTOWER³...

  • Page 20: Fig. 5 Qtower³ G Ivd Rear View

    Commissioning qTOWER G IVD Ventilation for fluorescence spectrometer Ventilation grille at the thermal cycler Service connection Mains connection Fuse holder for instrument fuses Mains switch Type plate USB port for PC connection Fig. 5 qTOWER³ G IVD rear view The type plate is also located on the rear of the device. The type plate shows the serial number of the device and the electrical connection data.

  • Page 21: Setting Up The Qtower 3 G Ivd

    qTOWER G IVD Commissioning The voltage selector switch is located on the bottom of the device, behind a cover. It can be used to adjust the operating voltage to the mains voltage (see "Setting up the qTOWER G IVD" p. 21). Fig.
  • Page 22 Commissioning qTOWER G IVD The following steps are required during the installation of the qTOWER³ G IVD:  Connect the device to the mains and the PC  Install the qPCRsoft IVD program on the PC 1. Remove the qTOWER³ G IVD, connection cable and operating manual with the installation CD or the USB memory stick from the transport packaging.

  • Page 23: Operation

    qTOWER G IVD Operation Operation Switching the qTOWER³ G IVD on Observe the following sequence when switching on the device: 1. Switch on the qTOWER³ G IVD using the mains switch on the back of the device. 2. Start the qPCRsoft IVD program. ...

  • Page 24: Inserting Samples / Starting The Pcr Analysis

    The qTOWER³ G IVD is equipped with a 96 well SBS sample block. Important: For in-vitro diagnostics, use the detection reagents and plastic products Analytik Jena or AJ Roboscreen GmbH specified for the corresponding qTOWER G IVD kit. Suitable accessories and consumables can be purchased from the manufacturers.

  • Page 25: Fig. 9 Position A1 On The Sample Block

    qTOWER G IVD Operation Fig. 9 Position A1 on the sample block 5. Close the lid. To do so, fold the lid forward and press it down from the handle until the lock engages with a click. 6. Start the PCR run in the qPCRsoft IVD program.

  • Page 26: Maintenance And Care

     Replacing the fuses All maintenance work and repairs beyond this scope must only be performed by Ana- lytik Jena customer service personnel or persons authorized by Analytik Jena. Any un- authorized interference limits warranty entitlements. If the device exhibits any faults or details, please contact the Analytik Jena customer service immediately.

  • Page 27: Disinfecting The Device

     If the qTOWER G IVD has to be sent to Analytik Jena for service, a prior decontam- ination must be carried out and documented (see "Return" p. 31).

  • Page 28: Exchanging Fuses

    3. Remove the old fuses and replace them with new ones. Fig.10 Fuse holder on the rear of the device If the fuses melt repetitively have the qTOWER G IVD checked by Analytik Jena cus- tomer service personnel or by persons authorized by Analytik Jena.

  • Page 29: Troubleshooting

    These are listed in the following chapter. All maintenance work and repairs beyond this scope must only be performed by Analytik Jena customer service personnel or by persons authorized by Analytik Jena. Any unauthorized interference limits warranty entitlements.

  • Page 30: Transport And Storage

    Transport and storage qTOWER G IVD Transport and storage Transport NOTICE Use suitable packaging material and transport locks! Unsuitable packaging material may cause damage to the device! Only transport the qTOWER G IVD in its original packaging and with the transport lock in place! Infor- mation on proper packaging is included with the device.

  • Page 31: Return

     Only use the original packaging for the shipment and insert the transport lock. If the original packaging is no longer available, please contact Analytik Jena or your local distributor.  Please attach the warning note "CAUTION! SENSITIVE ELECTRONIC DEVICE!"...

  • Page 32: Storage

    Disposal qTOWER G IVD Storage NOTICE Possible device damage due to environmental conditions and condensation water! 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.

  • Page 33: Specifications

    qTOWER G IVD Specifications Specifications 10.1 Technical data Block format 96 wells Sample volume 10 – 80 µL Lid temperature 30 – 110 °C Temperature gradient 40°C Max. heating rate* max. 8°C/s, 7°C/s Ø (depending on consumables used) Max. cooling rate* max.
  • Page 34 Specifications qTOWER G IVD Sensitivity 1 copy of the target sequence in human genomic DNA Measuring time 96-well plate (single measurement) approx. 6 s Measuring range ±130 000 (±17 bit) Dynamic range 10 log stages Light source Four high-intensity LEDs (blue, green, white, red) Detector Photo Multiplier (PMT) Color filter modules...

  • Page 35: 10.2 Standards And Directives

    The qTOWER³ G IVD contains restricted substances (according to directive GB/T Guidelines for China 26572-2011). Analytik Jena guarantees, that those hazardous substances may not leak out during the next 25 years when the PlasmaQuant MS is used in accordance with its intended purpose.

  • Page 36: Revision Overview

    Moved the revision overview from page 2 into chapter 11 Chapter 12 Decontamination declaration updated A (01/2021) 20.01.2021 Change of address from Analytik Jena AG to Analytik Jena GmbH due to change of company legal form Chapter 12 Decontamination declaration removed...

  • Page 37: Index

    qTOWER G IVD Index Index Air pressure 17 Operating manual conventions 5 Operating temperature 17 Care 26 Cleaning the housing 26 PCR thermocycler 16 Cleaning the sample block 26 Personnel 10 Commissioning 17 Protection type 35 Control elements 19 Rating plate 19 Decontamination 27 Return 31 Device safety 35...

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