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Experiment X Germany GmbH 

Perleberger Straße 42d

 

D-10559 Berlin 

Germany

 

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Igloo™ + Dx Care 

Instructions for Use

 

Contents

 

 

Introduction

 

 

Intended Use

 

 

Symbols Used in this Manual

  

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Safety Instructions

 

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Cautions

 

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General Precautions

 

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Prerequisites

 

 

Installing, Upgrading and Configuring the Software

 

 

Step-by-Step Instructions

  

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Before You Begin

 

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Measurement 

 

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Device Indicator Legend

 

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Cleaning, Turning off and Storing Your Igloo

 

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Troubleshooting

 

 

Technical Specifications

  

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Technical Data

 

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Scope of Delivery

 

 

Customer Support and Service Information

 

 

Copyright Information

 

Introduction 

Thank you for purchasing Igloo, an Experiment X products.

 

Igloo is a portable electronic measuring device for professional use in combination with in-vitro 
lateral  flow  tests.  It  supports  qualitative,  quantitative  and  semi-quantitative  lateral  flow 
immunochromatographic  and  colorimetric  tests  and  allows  the  in-vitro  examination  of 
specimens derived from the human body, as well as other biological samples. 

Igloo uses embedded firmware and can be used with its specially designed software only. Igloo 
measurement results can only be viewed with such software applications. 

Igloo is powered by a 2000 mAh Li-Ion battery or an USB-C cable included in the delivery. The 
USB-C cable can also be used for charging the device. 

Igloo  is  a  camera-based  device  enclosed  in  a  plastic  case  with  an  LED  indicator  ring,  a  touch 
sensor/button on the top, and a reset button on the bottom. 

Содержание Igloo

Страница 1: ...ent X products Igloo is a portable electronic measuring device for professional use in combination with in vitro lateral flow tests It supports qualitative quantitative and semi quantitative lateral flow immunochromatographic and colorimetric tests and allows the in vitro examination of specimens derived from the human body as well as other biological samples Igloo uses embedded firmware and can b...

Страница 2: ...s carefully before using your Igloo Intended Use Igloo is a portable electronic IVD medical device for professional use intended for reading processing and analyzing qualitative quantitative and semi quantitative in vitro lateral flow immunochromatographic and colorimetric tests It is intended to be used as a part of the Experiment X platform comprising Igloo and either the Dx Studio or the Dx Car...

Страница 3: ...t Experiment X may recommend their preferred shape and manufacturing method You must calibrate the device to each test batch or test type before using it for test reading The calibration procedure needs an NFC tag placed on the bottom of the cassette adapter The calibration procedure writes the test specific data to the NFC tag which the device will then transfer wirelessly using near field commun...

Страница 4: ...g the device Safety Instructions When used properly the device cannot adversely affect the life and health of patients Measurement results obtained using the device should always be analyzed by professionals Results obtained using rapid tests should only be interpreted by professionals in conjunction with other diagnostic procedures and clinical data to eliminate any false positive or false negati...

Страница 5: ...ids can cause irreparable damage to Igloo Do not clean Igloo with excess liquid and do not spray disinfectants directly onto or into it Considering these limitations the device can only be cleaned with a disinfectant solution e g Mikrozid AF Liquid Aerodesin 2000 or similar applied to a cloth Do not expose the device to strong electromagnetic radiation This may cause data to be lost Protect the de...

Страница 6: ...e Do not move or rotate the device during the measurement as this may cause its contamination or incorrect measurement results Preparing a test cassette without following the instructions may lead to incorrect test results The calibration data and other test specific information is written on the NFC tag on the underside of the test cassette adapter Be careful not to mix up adapters from different...

Страница 7: ...tall Dx Care on your computer or laptop The download link is https support Igloo today dxcare You can also find it at the bottom of the device and on the device s packaging Dx Care is available for Windows and MacOS Carefully read the End User License Agreement EULA shown at first application startup You may not use the product without accepting the End User License Agreement Dx Care automatically...

Страница 8: ...ould damage the device The work area should have enough free space to be able to easily insert and eject the test cassette adapter cartridge For the initial startup launch Dx Care and connect your Igloo to your computer via the supplied USB C cable To turn on your Igloo for further startups either 1 Connecting it via USB C cable to your computer OR 2 Pressing the touch button for 3 seconds The LED...

Страница 9: ...lect Control mode The device indicator will on breathe fast The application will prompt you to insert an adapter with the test cassette into the device Use gloves Prepare the test cassette following its instructions for use Igloo reads the incubation time and other important test information from the NFC tag Prior to the measurement make sure the NFC tag is located on the underside of the cassette...

Страница 10: ...evice before launching the application eject the adapter and insert it again The measurement process always starts with the countdown of the incubation time Note that this process cannot be undone or paused once started Do not eject the cassette adapter until the reading is complete If you eject the adapter for more than 10 seconds the incubation time will be reset and the application will ask to ...

Страница 11: ...r that the test results can be false positive or false negative for a variety of reasons Make sure to always have professionals double check the results obtained using the device using approved comparable diagnosis technique The manufacturer does not recommend starting a measurement if the battery level is below 9 as the device might run out of charge before the procedure is completed Nevertheless...

Страница 12: ...ing or printing the result make sure not to mix up the data between different measurements The manufacturer explicitly disclaims its responsibility for the correct placement and safety of measurement results Device Indicator Legend Color Mode Meaning Cases White Fast breath Igloo needs your attention or action also check notifications in the application Insert or eject the cassette adapter Measure...

Страница 13: ... each use After 10 minutes of inactivity the device indicator becomes less bright After 15 minutes Igloo automatically goes into standby mode If you touch the device before this time has passed the indicator will start breathing slowly and the device will wait for a new interaction Another way to turn off the device is to press the touch button and hold it for 3 seconds The device indicator bright...

Страница 14: ...as complete repeat the procedure with new test The battery is insufficiently charged connect the device via USB C cable results will be taken from the device if the measurement was finished 5 Self test error Contact support 6 Igloo not responsive Use the reset button located on the rubber at the bottom of the device Press the button release and then push again within 5 seconds to reset Igloo to it...

Страница 15: ...rinciple The test is done by measuring of the different colored lines test and control on a test strip The test lines are evaluated either qualitatively by checking whether the test band occurs at all or quantitatively semi quantitatively by calculating the color intensity according to the peak height or the surface area under the peak curve Both methods can be are used to determine the analyte co...

Страница 16: ...prox 200g Dimensions Height 91 mm Width 87 5 mm Depth 87 5 mm Connection USB C cable 2 0 or higher input power 5V min 1400 мА Wi Fi Bluetooth Module 802 11 b g n 2 4 GHz powered up 100 mW Issue date Expiration date Warranty One year if the number of battery recharge cycles will exceed 500 during the first year then warranty expires since the moment of this event Scope of Delivery Igloo device USB ...

Страница 17: ...8 79 EС Restriction of Hazardous Substances Directive 2011 65 EU The disposal of Igloo must be carried out in accordance with Regulation 2002 96 EC Customer Support and Service Information Igloo is maintenance free The device is designed to self test every time it is turned on The camera sensor automatically calibrates at regular intervals throughout its life cycle If you will keep the device clea...

Страница 18: ...ration of the warranty does not prohibit the use of Igloo the manufacturer is not responsible for the results obtained after the device expiration More information is available at https support Igloo today dxcare For additional information and support please contact support experimentx co Igloo is powered by a Li Ion 2000 mAh battery please follow the internal regulations of your country for the p...

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