Qiagen QIAreach eHub User Manual
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Qiagen QIAreach eHub User Manual

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QIAreach
User Manual
9002969
QIAGEN GmbH, QIAGEN Strasse 1, D-40724 Hilden
1118891EN
R2
Sample to
Insight__
October 2020
eHub
TM

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Summary of Contents for Qiagen QIAreach eHub

  • Page 1 October 2020 QIAreach eHub User Manual 9002969 QIAGEN GmbH, QIAGEN Strasse 1, D-40724 Hilden 1118891EN Sample to Insight__...
  • Page 2 QIAreach eHub User Manual 10/2020...

  • Page 3: Table Of Contents

    Contents Introduction ......................5 About this user manual ..................5 General Information ..................6 Intended use of the QIAreach eHub ..............6 Symbols on the QIAreach eHub ............... 8 Safety Information ....................10 Proper use ....................11 Electrical safety ....................11 Chemical safety ....................11 Biological safety ...................12...
  • Page 4 General information ..................26 Contacting QIAGEN Technical Services ............26 QIAreach eHub error codes ................26 Technical Specifications ..................32 Appendix A – Technical Data ..................34 10.1 FCC Compliance: Supplier’s Declaration of Conformity ........34 10.2 Waste Electrical and Electronic Equipment (WEEE) ........36 10.3 Disclaimer of warranties ................36 Ordering Information ....................37...

  • Page 5: Introduction

    1 Introduction This manual describes how to operate the QIAreach eHub. Before using the QIAreach eHub, it is essential that you read this user manual carefully and pay particular attention to the safety information. The instructions and safety information in the user manual must be followed to ensure safe operation of the instrument and to maintain the instrument in a safe condition.

  • Page 6: General Information

    Please contact QIAGEN Technical Services. 1.3 Intended use of the QIAreach eHub The QIAreach eHub is intended for use in conjunction with QIAreach in vitro diagnostic tests. QIAreach technology on the digital detection eStick provides diagnostic results that are displayed to the user on the QIAreach eHub visual display.
  • Page 7 When charging the QIAreach eHub, use only the USB charger and USB cable supplied with  this product. The QIAreach eHub should only be operated on a flat, horizontal surface with no angles or  tilts. Do not re-run a QIAreach assay eStick if it has already been used successfully or if it has been ...

  • Page 8: Symbols On The Qiareach Ehub

    1.4 Symbols on the QIAreach eHub The following symbols may appear on the packaging or labelling. Symbol Location Description Type plate and outer box label of the eHub CE mark Type plate on the bottom of the eHub FCC Mark...
  • Page 9 Type plate and outer box label of the eHub UL mark that indicates the instrument complies with the applicable standards for electrical safety Front of the eHub Biohazard QIAreach eHub User Manual 10/2020...

  • Page 10: Safety Information

    2 Safety Information Before using the QIAreach eHub, it is essential that you read this user manual carefully and pay particular attention to the safety information. The instructions and safety information in the user manual must be followed to ensure safe operation of the eHub and to maintain a safe working condition.

  • Page 11: Proper Use

     read and become acquainted with the Instructions for Use before running a QIAreach test. Improper use of the QIAreach eHub may cause personal injuries or damage to the eHub.  The QIAreach eHub must only be operated by qualified and appropriately trained QIAGEN ...

  • Page 12: Biological Safety

    The QIAreach eHub itself does not contain any biohazardous material. Samples tested on the QIAreach eHub may contain infectious agents. Users should be aware of the health hazard presented by such agents and should use, store and dispose of such samples according to the required safety regulations.

  • Page 13: General Description

    The QIAreach eHub USB charger and USB cable allow the eHub to be powered from either an electrical outlet or from a computer equipped with USB ports. Use of the optional QIAreach software requires the QIAreach eHub to be connected to a computer.
  • Page 14 Battery LED indicator  Figures 1 and 2 show the location of various QIAreach eHub features. Figure 1. Front view of QIAreach eHub. Figure 2. Side view of QIAreach eHub. QIAreach eHub User Manual 10/2020...

  • Page 15: Installation Procedures

    4 Installation Procedures 4.1 Site requirements Select a flat, dry, and clean workbench space for the QIAreach eHub. Make sure that the space is free of excessive moisture and dust, protected from direct sunlight, large temperature fluctuations, heat sources, vibration and electrical interference. Refer to Section 9 for the weight and dimensions of the QIAreach eHub and the correct operating conditions (temperature and humidity).

  • Page 16: Qiareach Ehub Delivery And Components

    4.2 QIAreach eHub delivery and components The QIAreach eHub is delivered in a single box and includes all the necessary components for setting up and connecting the eHub. The contents of the box are described below: Note: QIAreach tests kits (sold separately) are required to perform QIAreach testing.
  • Page 17 The following components are required for testing but are provided in separate test kits. These components can be purchased separately. Components Description QIAreach eStick – product specific Processing Tube – product specific Buffer – product specific QIAreach eHub User Manual 10/2020...

  • Page 18: Unpacking And Installing The Qiareach Ehub

    Remove the QIAreach eHub from its delivery box and place on a flat, level surface. The QIAreach eHub should be charged prior to use. To charge the eHub, connect the USB cable from the QIAreach eHub USB port to either the supplied power adapter or to a computer. While charging, the Battery LED indicator flashes a green light.

  • Page 19: Operating The Qiareach Ehub

    QIAreach software, then we recommend to connect the QIAreach eHub to a power outlet (if available) through the provided USB power adapter and USB cable. 3. To turn on the QIAreach eHub, press ON/OFF on the side of the unit until the visual display screen lights up.
  • Page 20 Once the QIAreach eHub is ready for use, the visual display screen above each available QIAreach eStick connection port will display the “Insert eStick” icon shown below. Figure 6. Insert eStick icon. This signifies that a QIAreach eHub port is available for use.

  • Page 21: Running A Test On The Qiareach Ehub

    Note: Each of the connection ports on the QIAreach eHub operates separately. Up to eight (8) QIAreach tests can be run simultaneously. 1. When a QIAreach test eStick has been inserted in a QIAreach eHub connection port, the self- test icon will be displayed while the eStick performs a self-test.

  • Page 22: Shutting Down The Qiareach Ehub

    Figure 11. Error icon and associated error code. 5.3 Shutting down the QIAreach eHub After use, the QIAreach eHub should be turned off by pressing and holding the ON/OFF button for >2.5 seconds. The QIAreach eHub battery will continue to charge when turned off if connected to a power source.

  • Page 23: Qiareach Ehub Functions

    Icon Description Please Insert The QIAreach eHub port is available for eStick use. Self-test The eStick has been inserted and a self-test is being performed. The eStick is ready for sample addition to the detection port. The sample must be Add sample added within 60 minutes of removing the eStick from the foil packaging.

  • Page 24: Battery Led Indicator

    6.2 Battery LED indicator If not connected to a power source, the QIAreach eHub should have sufficient battery power to complete all in-progress QIAreach tests. A fully charged QIAreach eHub should maintain internal battery power for at least 8 hours. QIAreach tests should not be performed if the battery power is less than 10% and is not connected to a power source.

  • Page 25: Maintenance

    When cleaning the QIAreach eHub surface: Wear laboratory gloves, coat, and protective glasses.  Wet a paper towel in mild detergent and wipe down the QIAreach eHub surface and the  surrounding workbench area. Take care not to intentionally wet the eStick connection ports or ON/OFF button and USB port.

  • Page 26: Troubleshooting

    Frequency of error occurrence (i.e., intermittent or persistent error)  Photo of error, if possible  8.3 QIAreach eHub error codes If the QIAreach eHub displays an error code, refer to the table below specific error descriptions and solutions. QIAreach eHub User Manual 10/2020...
  • Page 27 Table 2. QIAreach eHub error codes categories – general description Error type Error code format Description Self-Test A-[Error code] eStick electronic failure Algorithm B-[Error code] Run error or user workflow error Communication/ C-[Error code] Invalid data or missed communication Other between eStick and eHub Table 3.
  • Page 28 A-32768 Dark Frequency Failure Remove and re-insert the eStick. If error persists, discard and use new eStick. A-65535 Unknown value Remove and re-insert the eStick. If error persists, discard and use new eStick. QIAreach eHub User Manual 10/2020...
  • Page 29 Discard and use new eStick. B-255 Test Removed Early Wait for test completion before removing eStick. Discard and use new eStick. * See Troubleshooting Guide section of applicable kit Instructions for Use regarding optical interference. QIAreach eHub User Manual 10/2020...
  • Page 30 Algorithm Failure Remove and re-insert the eStick. If error persists, discard and use new eStick. If error persists with new eStick, discontinue use of eHub port. Table continued on next page QIAreach eHub User Manual 10/2020...
  • Page 31 C-15 eHub Internal Error The eHub can no longer be used. Contact QIAGEN Customer Support. C-16 eHub RTC Failure The eHub can no longer be used. Contact QIAGEN Customer Support. QIAreach eHub User Manual 10/2020...

  • Page 32: Technical Specifications

    Air Temperature 15–30°C (59–86°F) Relative Humidity 30–65% (non-condensing) RoHS (Responsibility of Health and Safety) Compliance: Compliant with RoHS 3 EU Directive 2015/863: Restriction of the Use of certain  Hazardous Substances in electrical and electronic equipment QIAreach eHub User Manual 10/2020...
  • Page 33 Meets the requirements of FCC Title 47 CFR Part 15 Subpart B– unintentional radiators  as a Class A device Electrical Safety Compliant with IEC 61010-1: Safety requirements for electrical equipment for  measurement, control, and laboratory use - Part 1: General requirements QIAreach eHub User Manual 10/2020...

  • Page 34: Appendix A - Technical Data

    10 Appendix A – Technical Data 10.1 FCC Compliance: Supplier’s Declaration of Conformity 47 CFR § 2.1077 Compliance Information Unique Identifier: 9002969 – QIAGEN QIAreach eHub Responsible Party – U.S. Contact Information QIAGEN Inc. - USA 19300 Germantown Road Germantown, MD 20874 Telephone: (800-362-7737) Email: customercare-us@qiagen.com...
  • Page 35 • Plug the equipment into a different outlet so that the equipment and the radio/television receiver are on different power mains branch circuits. • Consult a representative of QIAGEN or an experienced radio/television technician for additional suggestions. In order to maintain compliance with FCC regulations, this equipment must be used with the supplied USB cable and USB Charger.

  • Page 36: Waste Electrical And Electronic Equipment (Weee)

    Recycling can be provided by QIAGEN upon request at additional cost. In the European Union, in accordance with the specific WEEE recycling requirements and where a replacement product is being supplied by QIAGEN, free recycling of its WEEE-marked electronic equipment is provided.

  • Page 37: Ordering Information

    1 QIAreach eHub dust cover For up-to-date licensing information and product-specific disclaimers, see the respective QIAGEN kit handbook or user manual. QIAGEN kit handbooks and user manuals are available at www.qiagen.com or can be requested from QIAGEN Technical Services or your local distributor.

  • Page 38: Document Revision History

    Updated the Symbols section to add the RoHS, UL, and Biohazard symbols Added the Biohazard warning in the Biological Safety section Updated the Unpacking and installing the QIAreach eHub section to add information about the Battery LED indicators on the eHub...
  • Page 39 QIAGEN specifically disclaims any other licenses, expressed or implied other than those expressly stated. The purchaser and user of the kit agree not to take or permit anyone else to take any steps that could lead to or facilitate any acts prohibited above. QIAGEN may enforce the prohibitions of this Limited License Agreement in any Court, and shall recover all its investigative and Court costs, including attorney fees, in any action to enforce this Limited License Agreement or any of its intellectual property rights relating to the kit and/or its components.
  • Page 40 Ordering www.qiagen.com/shop | Technical Support support.qiagen.com | Website www.qiagen.com QIAreach eHub User Manual 10/2020...

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