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PEBBLE qcLAMP Platform

A point-of-care diagnostic platform for nucleic acids detection

in clinical samples using real-time

quantitative colorimetric loop-meditated isothermal amplification (qcLAMP).

PPL-01-INSTRUCTIONS FOR USE | v1.1 | DATE OF

ISSUE: 10.08.2021

BIOPIX DNA TECHNOLOGY P.C.

Science and Technology Park of Crete
N. Plastira 100, Vassilika Vouton
GR-700 13, Heraklion, Greece

www.biopix-t.com

[email protected]

(+30) 281 0391986

For

in vitro

diagnostics use.

For professional use only.

000057

Содержание PEBBLE qcLAMP Platform

Страница 1: ...tric loop meditated isothermal amplification qcLAMP PPL 01 INSTRUCTIONS FOR USE v1 1 DATE OF ISSUE 10 08 2021 BIOPIX DNA TECHNOLOGY P C Science and Technology Park of Crete N Plastira 100 Vassilika Vo...

Страница 2: ...U S E v1 1 10 08 2021 This Instructions for Use IFU complies with the requirements of EN ISO 18113 3 2019 IEC 61326 2 6 2020 and IEC 61010 2 101 2018 The labels used and described into the next sectio...

Страница 3: ...cLAMP Platform will conform to its specifications and performance for a period of 12 months after its shipment date from the Seller Non complying with the warnings and precautions as well as the produ...

Страница 4: ...Detection Kits 9 C Equipment 9 D Consumables 9 6 WARNINGS AND PRECAUTIONS 9 7 INSTRUMENT INSTALLATION 11 8 TEST PROCEDURE 17 9 BIOPIX T CLOUD SYSTEM 37 10 RESULTS INTERPRETATION 39 11 CLEANING INSTRUC...

Страница 5: ...PEBBLE qcLAMP Platform 5 I N S T R U C T I O N S F O R U S E v1 1 10 08 2021...

Страница 6: ...el limited resource areas etc The PEBBLE qcLAMP Platform is intended to be used only with test kits produced by BIOPIX DNA TECHNOLOGY P C COV19 qcLAMP kit CAT 000055 and Flu A qcLAMP kit CAT 000056 Th...

Страница 7: ...as color index units versus time The device connects via Bluetooth to a smart device mobile phone or tablet and operates through an Android application named PEBBLE Platform powered by BIOPIX DNA Tec...

Страница 8: ...r supply with a 5 V DC 6 Heating Element Heats the vials 7 Camera Records the pixels of the color change in the vials 8 White LED Lights Illuminates the chamber 4 STORAGE AND HANDLING REQUIREMENTS Kee...

Страница 9: ...ety should be followed in all circumstances Use nuclease free disposable plasticware and pipette tips Testing should be performed in an appropriate equipped facility by trained personnel Use the devic...

Страница 10: ...ot disassemble the PEBBLE qcLAMP device as it might result to performance issues Do not touch or move neither the camera nor camera lens Sensitivity can be significantly reduced Post amplification qcL...

Страница 11: ...e If it is damaged do not open and contact BIOPIX T technical support 7 1 2 Unbox PEBBLE components Take out PEBBLE qcLAMP Platform power supply body and power plug Check the items If they are damaged...

Страница 12: ...O N S F O R U S E v1 1 10 08 2021 7 2 INSTALLATION OF APPLICATION AND REGISTRATION 7 2 1 Open Google Play Store on your Android device Search for the PEBBLE Platform application powered by BIOPIX T do...

Страница 13: ...PEBBLE qcLAMP Platform 13 I N S T R U C T I O N S F O R U S E v1 1 10 08 2021 7 2 3 Locate Choose Language option 7 2 4 Choose language current available languages are English and Greek...

Страница 14: ...R U C T I O N S F O R U S E v1 1 10 08 2021 7 2 5 Locate Register button 7 2 6 Fill in the fields with the requested info In order to be able to register user has to accept the terms of use and privac...

Страница 15: ...I N S T R U C T I O N S F O R U S E v1 1 10 08 2021 7 2 7 Click on the REGISTER button A verification code will be sent to your registered e mail account 7 2 8 To verify and activate your account cli...

Страница 16: ...PEBBLE qcLAMP Platform 16 I N S T R U C T I O N S F O R U S E v1 1 10 08 2021 7 2 9 Fill in your email assigned to the account and the received activation code 7 2 10 Click on VERIFY...

Страница 17: ...uctions for Use for both the kit and the PEBBLE qcLAMP Platform before starting the test Ensure that your PEBBLE qcLAMP Platform device will be operating in environmental conditions as described in se...

Страница 18: ...plugging the power supply When O is pressed the device is OFF When I is pressed the device is ON 8 1 2 Turn on the device 8 1 3 You need to wait approximately two to three minutes 2 3 min for the syst...

Страница 19: ...ng the registered e mail and password Make sure that you have enabled the Bluetooth option on your smart device 8 1 6 After login you will be redirected to the home menu Your smart device will ask to...

Страница 20: ...R U C T I O N S F O R U S E v1 1 10 08 2021 8 1 7 Click on option Connect 8 1 8 Available devices will show up automatically You can also scan for devices by clicking on the blue search button on the...

Страница 21: ...qcLAMP Platform 21 I N S T R U C T I O N S F O R U S E v1 1 10 08 2021 8 1 9 Once device is found click on the CONNECT button in order to pair your smart device with the available PEBBLE Otherwise sca...

Страница 22: ...latform 22 I N S T R U C T I O N S F O R U S E v1 1 10 08 2021 8 1 10 You will be automatically redirected to hardware diagnostics check screen 8 1 11 If everything is fine you will be redirected in t...

Страница 23: ...e contact BIOPIX T see section 13 2 Technical Support For example if temperature sensor is disconnected you will see a message Same for camera led light and hardware controls 8 1 12 After completing t...

Страница 24: ...R U C T I O N S F O R U S E v1 1 10 08 2021 It is found either on the bottom of the device or on the side of the PEBBLE packaging The assign verification takes place only during the first connection...

Страница 25: ...S F O R U S E v1 1 10 08 2021 8 2 ADD CONSUMABLES STEP DESCRIPTION IMAGE 8 2 1 To load consumables click on the Add Consumables button 8 2 2 A pop up window will appear to scan your data matrix code i...

Страница 26: ...O R U S E v1 1 10 08 2021 Your smart device will ask to allow Pebble Platform application to take pictures and record video via a popup window To use the application permissions must be allowed 8 2 3...

Страница 27: ...llow the aforementioned steps For any new purchased kit you should follow the same process 8 3 PREPARE YOUR SAMPLES STEPS DESCRIPTION IMAGE For this step please refer to the respectively Instruction f...

Страница 28: ...qcLAMP Platform 28 I N S T R U C T I O N S F O R U S E v1 1 10 08 2021 8 4 PERFORM ANALYSIS AND START TESTING STEP DESCRIPTION IMAGE 8 4 1 Click on Perform analysis button 8 4 2 Click on Number of sa...

Страница 29: ...T R U C T I O N S F O R U S E v1 1 10 08 2021 8 4 3 Set number of samples ranging from minimum 1 to maximum 6 and click ok When selecting the number of samples you should include your control sample...

Страница 30: ...C T I O N S F O R U S E v1 1 10 08 2021 8 4 5 Select the name of consumable that you will use for the run You may have more than one options based on the purchased kits The number of available runs is...

Страница 31: ...th data Green border color indicates that the slot has no data yet and needs to be filled with data Grey background indicates that the current slot is unavailable 8 4 8 Click on the various fields and...

Страница 32: ...you assign the properties to all samples the slots are activated by changing color from white to green DO NOT PRESS YET THE START BUTTON 8 4 10 When your samples are prepared push them in the tube hol...

Страница 33: ...m 33 I N S T R U C T I O N S F O R U S E v1 1 10 08 2021 8 4 11 Once you have inserted the tube holder inside the main body of PEBBLE qcLAMP device click the START button 8 4 12 A short validation pro...

Страница 34: ...N S T R U C T I O N S F O R U S E v1 1 10 08 2021 8 4 13 A green LED light on top of the PEBBLE device should light up to indicate that the test run started 8 4 14 The data curves are displayed in re...

Страница 35: ...programmed to run for a specific time and it will stop automatically In case you want to abort the test simply click on the red STOP button on the top left corner and Confirm that you want to be redi...

Страница 36: ...hen removing the tube holder from the main body of PEBBLE DO NOT OPEN the post amplification tubes as there is a high risk of contaminating the area including the device In case of an incident please...

Страница 37: ...A pop up message will appear Click on CONFIRM and you will be automatically redirected to the home menu Any recorded data up to the stop time will be available through the cloud service For accessing...

Страница 38: ...S E v1 1 10 08 2021 9 1 USE OF CLOUD SYSTEM STEP DESCRIPTION IMAGE 9 1 To access your data click on the Tests History tab in home menu 9 2 You can filter and select by date or and by device of your ch...

Страница 39: ...ser POSITIVE TEST RESULTS o The specific time point at which a change in the slope of the real time curve occurs color index units increase corresponds to the time to positive result red solid line Th...

Страница 40: ...AMP Platform has been validated for use with COV19 qcLAMP kit BIOPIX T CAT 00055 and FLU A qcLAMP kit BIOPIX T CAT 000056 only For reliable results it is essential to adhere to this IFU as well as to...

Страница 41: ...ructions for use of the IVD kit False Negative Samples with lower or close to the limit of detection Consult the instructions for use of the IVD kit Incorrect heating temperature Contact BIOPIX T Devi...

Страница 42: ...he device Contact BIOPIX T Heating element does not work Electrical failure Contact BIOPIX T Over heating Temperature sensor is detached Contact BIOPIX T Loss of sensitivity Camera lens has relocated...

Страница 43: ...rsion installed prior to this update New Version Identifies the operating system s version that will be installed after this update What s New Debriefs what has changed to the new version of the appli...

Страница 44: ...safety tests and complies with the requirements IEC 61010 2 101 2018 and IEC 61326 2 6 2012 17 REFERENCES 1 G Papadakis et al Real time colorimetric LAMP methodology for quantitative nucleic acids det...

Страница 45: ...ndle with care Indicates a medical device that can be broken or damaged if not handled carefully Waste Electrical and Electronic Equipment To indicate that the product should not be discarded as unsor...

Страница 46: ...eness or operator action to avoid undesirable consequences Wireless Communications To identify the control that enables or activates wireless communications To indicate the operational status of the w...

Страница 47: ...ase Chain Reaction qcLAMP quantitative colorimetric Loop mediated isothermal amplification RNA Ribonucleic acid UI User Interface UK United Kingdom US United States UPS Uninterruptible Power Supply 20...

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