USER MANUAL abioSCOPE
Contents
1. according to ISO 9001 2008 and ISO 13485 2003 and annex Il section 3 of directive 93 42 EEC The medical device is classified as active diagnostic device in class according to the annex IX and fulfils the essential requirements according to annex of directive 93 42 EEC USER MANUAL abioSCOPE 01 Version EU 1 0 Page 9 39 Operating conditions Main power supply 110 240V 50 60 Hz Current rating 1 7A Operating temperature 18 C 25 C Relative humidity 20 80 To avoid the risk of electric shock this equipment must only be connected to a mains electricity supply fitted with a protective earth Only use the provided power supply 100 240 VAC 50HZ Laser information The laser is located inside the abioSCOPE and the beam is not accessible from outside As the beam used inside the abioSCOPE is harmful to eyes do not attempt to open or disassemble the housing Refer servicing of the abioSCOPE to qualified personnel only The abioSCOPE integrates two Class 3B lasers which emit laser radiation in the red Internal laser radiation Wave lengths 635nm and 780nm Output power lt 35mW Class 3B The abioSCOPE should not be opened under any circumstances Laser beam Do not use the abioSCOPE without the device housing due to harmful light intensity causing permanent eye injury USER MANUAL abioSCOPE 01 Version EU 1 0 Page 10 39 The following label is located on the abioSCOPE housing2. Figure 1 1 abioSCOPE laser class 1 warning label The following label is located inside the abio SCOPE Figure 1 2 abpioSCOPE laser class 3B warning label USER MANUAL abioSCOPE 01 Version EU 1 0 Page 11 39 2 System Components About the System s Components The abioSCOPE is a biomedical device that provides rapid low cost allergy diagnosis abioSCOPE tests are designed to be complementary to skin tests and to offer quantitative in vitro allergy analysis at the point of care Abionic technology is user friendly users do not need special training and the device provides to the user a support for clinical diagnosis of IgE mediated allergic disorders thanks to a clear concise result for up to 10 different allergens per capsule within 20 minutes Operating the abioSCOPE is straightforward The patient s blood sample is mixed with a proprietary reagent abioMIX and placed into a special test capsule that contains biosensors capable of quantifying IgE levels The capsule is placed into an abioDISC mounting plate that is then inserted into the abioSCOPE in the same way that a DVD is inserted into a player The results are then presented on a touch screen and saved onto a SD card provided by Abionic which can be read by all standard SD card readers SD card Touchscreen abioSCOPE abioDISC support Capsule Power supply 100 240 VAC 50Hz USER MANUAL abioSCOPE 01 Version EU 1 0 Page 12 39 AADIONIC Optional wall su
3. 01 Version EU 1 0 Page 30 39 Troubleshooting E001 Hardware failure at Startup On starting up the system enters a short initialization phase that involves the system checking the functionality of the abioSCOPE If one or several functions do not initialize properly the system will not be usable and the following error message will appear on screen Hardware failure WON CENTET Sec The user should restart the abioSCOPE If the problem persists please contact Abionic customer service at service abionic com USER MANUAL abioSCOPE 01 Version EU 1 0 Page 31 39 A AaDIONIC E002 No SD Card inserted missing SD card A SD card must be inserted into the abioSCOPE before starting the device If the SD card is missing during the initialization process the following screen will invite the user to insert a SD card into the dedicated slot The abioSCOPE will then immediately continue its initializing process H No SD Card Pease insert SO Card If this screen appears when a SD card is present in the abioSCOPE check that the SD card is correctly inserted by removing it completely and re inserting it Check that the SD card is correctly orientated the metal contacts should not be visible and that the SD card is the one provided by Abionic special format If the problem persists check whether the SD card is damaged by inserting another one If the problem persists then the abioSCOPE could be d
4. 5 Alexanian Clyde 22 04 2015 B 73 22 56 Alge Coral 22 04 2015 B 53 57 95 AlmeterDee 22 04 2015 B 91 79 26 Alsbrook Denisse 22 04 2015 B 51 60 51 Amack Duncan 22 04 2015 B B1 97 39 Amancio Earle 22 04 2015 B 75 60 86 Amell Elene 22 04 2015 B 14 57 19 Amorin Emanuel 22 04 2015 B 50 41 89 Andradez Ezequiel 22 04 2015 B 85 52 88 Antonopoulos Halley Previous results 2 Next results Armat ID Capsule Type Capsule Type 4 Capsule Type 4 Total IgE Capsulse Type 2 Capsule Type 3 Capsule Type 3 Total IgE Capsule Type 4 Capsule Type 4 Total IgE Capsule Type 3 Capsule Type 4 Total IgE Capsule Type 3 Capsule Type 4 Capsule Type 3 Capsule Type 3 Capsule Type 3 Capsule Type 3 Capsule Type 3 Search for a specific archived result generated by the abioSCOPE using one of the following search filter date patient ID patient name sample ID or capsule type name Click on a specific row to display full details about the result see screen 3 USER MANUAL abioSCOPE 01 Version EU 1 0 Page 26 39 Patient Information ID 123457 Name OWER Sample information ID ASFG Test results A aDIONIC Test information Capsule type Beta Test Capsule ID 01 00001 Abio SCOPE ID ECHO debug DS Control measurements Passed Date 20 02 2015 Allergy Control Control Birch Birch Timothy Olive Cat Dog Mite Cattle Chicken Peanut positive negative rBet v 1 rBet v 2 rPhi p 1 role a 1 Feld 1 ran f 1
5. 8340 Capsule Type 4 22 04 2015 6 71 43 63 Aleizar Clarice S 708396 Capsulse Type 2 22 04 2015 B 5648 73 Abbadessa Agripina 5 720555 TotallgE 22 04 2015 Abke Allegra S d23807 Capsulse Type 2 22 04 2015 6 41 53 18 Aboytes Alton 5 219558 Capsulse Type 2 22 04 2015 68 55 79 62 Abrantes Amalia S 661666 Total IgE 22 04 2015 8 80 28 79 Aceituno Angelo S 721065 Capsulse Type 2 22 04 2015 6 36 17 95 Acencio Angelyn 5 848715 Capsule Type 3 The homepage displays you the last 20 results generated by the abioSCOPE Click on display the search tool button to search amp find archived results using several available search filters see screen 2 Click on a specific row to display full details about the result See screen 3 USER MANUAL abioSCOPE 01 Version EU 1 0 Page 25 39 EN lt search panel A aDIONIC Search A o pa A dh rara LATI S 627358 S 722805 5 512042 o 120665 S B42573 S 226399 5 917534 501349 5 100251 5 975521 o 549843 5 495700 o 177837 Data 23 04 2015 Result list wee Mon Tue Wed Thu Fi Set Sun Date Patent ID Wo O Bd 22 04 2015 B 99 75 60 ie 22 04 2015 B 51 10 94 fen os 22 04 2015 B 27 28 23 gt gt 22 04 2015 B 80 86 97 Auarnonrrwiarnuie 22 04 2015 B 78 43 15 Addeo Arturo 22 04 2015 B 66 94 52 Addo Ashli 22 04 2015 B 81 66 72 Aita Carlos 22 04 2015 B 25 20 26 Akmal Cassy 22 04 2015 B 88 84 33 Alby Ch ryle 22042015 B 78 97 72 Alcaraz Chieko 22 04 2015 B 27 76 1
6. IONIC HTM stored in the SD card Recommended system requirements At least 1GHz CPU At least 256MB of RAM Internet Explorer 8 Google Chrome Firefox 3 Opera 9 or Safari 3 JavaScript is turned on for the browser Windows XP Vista 7 8 10 or later Mac OS X 10 4 or later Ubuntu 10 4 and Fedora 19 USER MANUAL abioSCOPE 01 Version EU 1 0 Page 24 39 m abion Printing results procedure Insert the SD card into your computer s SD card slot Double click on the file ABIONIC HTM which will be opened by your Web browser abionic EN Display the search taal Last 20 diagnostics generated Date Patient ID Patient Name sample ID Capsule Type 22 04 2015 B 84 11 23 Abdin Albina 5 311203 Capsulse Type 2 22 04 2015 B 82 59 89 Abdullah Alejandra S 964096 Capsule Type 3 22 04 2015 B 71 73 98 Able Allene 5 107965 Total IgE 22 04 2015 B 84 18 40 Abson Anastasia 5 111812 Capsulse Type 2 22 04 2015 B 91 87 71 Acemo Angila 5 606880 Capsulse Type 2 22 04 2015 B 74 91 27 Affelt Bernard 5 284423 Total IgE 22 04 2015 6 59 70 83 Agee Bethel 5 429145 Capsule Type 3 22 04 2015 B 84 40 35 Adler Bill S 107467 Capsule Type 3 22 04 2015 B 26 38 61 Aguilar Breana 5 858 7 54 Total IgE 22 04 2015 6 41 80 95 Aguinaldo Brenda 5 133410 Capsule Type 4 22 04 2015 6 45 17 74 Ahner Buford S 420989 Capsulse Type 2 22 04 2015 B 20 24 40 Albares Charise 5 793135 Capsule Type 4 22 04 2015 B 14 14 66 Alcalde Ch t 5 99
7. OSTIC TEST to start the testing sure that the capsule is correctly set in the touching DISC TRAY on the screen Be careful sequence abioDISC and that the abioDISC is the correct not to trap your fingers when closing the tray Note you can come back to previous screens by EEN touching BACKWARD on the screen Never use a defective capsule e g one that is leaking or cracked etc USER MANUAL abioSCOPE 01 Version 1 0 Page 20 39 The testing sequence will now start and a circle progress bar will be displayed It takes approximately 5 minutes to get the measurement completed for 1 test and approximately 20 minutes to get measurement completed for 10 tests USER MANUAL abioSCOPE 01 Version 1 0 At the end of the test sequence the results are displayed and recorded onto the SD card By touching QR CODE a code will be displayed for retrieving results by the abioGUIDE application see step 9 Touch DISC TRAY to access the abioDISC and retrieve the used capsule see step 10 Pine can the UD coda using the ao GUIDE application By touching RESULTS the user will return to the results screen screen 8 Page 21 39 Si AN abIONIC By touching HOME the user will return to the Always remove the used capsule and dispose of welcome screen screen 1 it in an appropriated biohazard container The abioDISC but not capsules may be stored in the abioSCOPE drive when
8. PE It should be disposed of in a biohazard container Be aware that the test is performed with human whole blood plasma or serum which may carry a risk of transmitting infectious agents USER MANUAL abioSCOPE 01 Version EU 1 0 Page 28 39 6 abioSCOPE configuration Entering the Responsible Physician s and user information Turn the abioSCOPE on The welcome screen will appear The next step is to register the details of the responsible physician on the abioSCOPE and the name of the person performing the tests Touch CONFIGURATION on the Home screen and the following screen appears PRI EE EK ER La USER MANUAL abioSCOPE 01 Version EU 1 0 Page 29 39 The physician s office information as well as the person s name performing the test can now be entered This information will appear in the results file that is stored on the SD card Select the appropriated field by touching the corresponding white area enter the information using the keyboard and touch DONE when finished This information will remain in the system until changed For example if there are several people using the system each user should enter their own name prior to conducting a test However the name and address of the responsible physician does not need to be re entered at each time There is only one keyboard type Switzerland QUERTZ It only offers capital letters and has no accents USER MANUAL abioSCOPE
9. WADIONIC NANOTECHNOLOGY FOR HEALTHCARE EXPERTS abioSCOPE USER MANUAL Version EU 1 0 c 2015 Abionic SA A aDIONIC Abionic SA EPFL Innovation Park B CH 1015 Lausanne SWITZERLAND info abionic com http www abionic com Document version EU 1 0 USER MANUAL abioSCOPE Copyright 2015 Abionic SA All rights reserved Reproduction in whole or in part is prohibited without the prior written consent of the copyright holder The information in this book is subject to change without notice Print History Version Publication Date Reason for Revision Issue USER MANUAL abioSCOPE 01 Version EU 1 0 Page 2 39 Warranty The information contained in this document is subject to change without notice Abionic makes no warranty of any kind with regard to this material including but not limited to the implied warranties of merchantability and fitness for a particular purpose Abionic shall not be liable for errors contained herein or for incidental or consequential damages in connection with the furnishing performance or use of this material This product may contain remanufactured parts equivalent to new in performance or parts that have had incidental use Warnings The abioSCOPE uses laser components The device casing must not be opened except by the manufacturer or an authorised specialist Unauthorised opening of the casing and breaking of the security seal will render the guarantee invalid w
10. abioSCOPE is probably damaged and should be returned to Abionic please contact Abionic customer service at service abionic com E006 Disc tray is blocked If the disc tray is partially opened touch DISC TRAY twice to close and open the disc tray correctly If the disc tray is blocked in its closed position restart the abioSCOPE If the disc tray cannot be opened then the abioSCOPE is probably damaged and should be returned to Abionic please contact Abionic customer service at service abionic com USER MANUAL abioSCOPE 01 Version EU 1 0 Page 34 39 AN aDIONIC E007 Capsule missing Only certified capsules provided by Abionic should be inserted into the abio SCOPE Capsules must be new and unused If a capsule is missing or if a non compatible capsule is inserted the abioSCOPE will detect it and invite the user to insert a new compatible capsule The following screen will be displayed Touch BACKWARD and follow the instructions displayed on the screen USER MANUAL abioSCOPE 01 Version EU 1 0 Page 35 39 E008 abioDISC missing Only official disc supports abioDISC provided by Abionic should be used with the abioSCOPE If an abioDISC is missing or if a non compatible abioDISC is inserted the abioSCOPE will detect it The following screen will be displayed Touch BACKWARD and follow the instructions displayed on the screen The abioSCOPE can only read approved abioDISCs Do not inse
11. amaged Please contact Abionic customer service at service abionic com USER MANUAL abioSCOPE 01 Version EU 1 0 Page 32 39 E003 SD Card full During the initialization phase at start up the system controls the remaining space on the SD card If the SD card is full the following screen will appear SD Card full Pirase insert mew SO Card The user must replace the SD card with a new one provided by Abionic Then touch RETRY E004 Touchbutton is not responding interface software is frozen If the touchscreen does not respond within 20 seconds except during the measurement time restart the abioSCOPE If the abioSCOPE still not responds when the touchscreen is touched several times then read through the list of possible causes below e As for any capacitive touchscreen users should take care to correctly touch the screen longer contact time avoid touching with finger nails etc e Ensure that the users gloves are not too thick the abioSCOPE touchscreen has been designed to be used only with standard medical gloves Please try wearing thinner gloves e Initialization at start up can cause the touchscreen to block If this happens the abioSCOPE should be restarted USER MANUAL abioSCOPE 01 Version EU 1 0 Page 33 39 E005 Disc tray is not opening If the disc tray does not open when DISC TRAY is pressed restart the abioSCOPE If the disc tray cannot be opened then the
12. e that the capsule is correctly set in the abioDISC and that the abioDISC is the correct way up as per the above diagram Never use a defective capsule e g one that is leaking or cracked etc Please follow steps 1 to 3 of the analysis procedure in order to open abioSCOPE disc tray Page 18 39 Analysis procedure Turn the abioSCOPE on The welcome screen will appear The welcome screen invites you to choose between configuring the abioSCOPE and starting a diagnostic test Touch ALLERGY TEST see step 2 or CONFIGURATION see chapter 6 abioSCOPE configuration USER MANUAL abioSCOPE 01 Version 1 0 Patient information Paes erase Owe RTZUNGoeP AS DEG H J RK Zei E p Ve D TT i When launching a diagnostic test the first screen requires the user to input patient and sample information for identification and documentation purposes Select fields by touching the relevant white area Enter the information using the keyboard and when finished touch FORWARD DIAGMOSTIO TEST 3 Load dic watt the martedi capsule t Chatta dee ra GENT G ns tant Touch DISC TRAY to open the disc tray The process can be cancelled by touching BACKWARD Page 19 39 L Open tha dee ina Dren the chee ina 2 Load cite wath tha martedi Capsule L Chea thet dae ira an When placing the abioDISC in the disc tray make After inserting the abioDISC close the disc tray by Touch DIAGN
13. he abioSCOPE is placed on a wall support unscrew and remove the abioSCOPE from the wall support Visually control the electrical pins on the support Place the abioSCOPE again on its support and secure it with its dedicated screw In all cases check the electrical plug by testing another device on the same plug If the other device is working properly and not the abioSCOPE please contact Abionic customer service at service abionic com In case of a power failure during the measurement restart the abioSCOPE remove the used capsule and start the diagnostic test with a new capsule USER MANUAL abioSCOPE 01 Version EU 1 0 Page 38 39 er A ADIONIC E013 Problem using the abioCARD If the SD card is not correctly inserted in your computer or if the data stored are corrupted the abioCARD tool will detect it and will display on screen the following error message An error occur while starting the application Please contact Abionic Customer Service Service abionic com The user must replace the SD card with a new one provided by Abionic If the problem persists please contact Abionic customer service at service abionic com USER MANUAL abioSCOPE 01 Version EU 1 0 Page 39 39
14. ith immediate effect Electrical Shock Hazard Do not remove system covers To avoid electrical shock use only supplied mains cord set and power leads and connect only to properly earthed main power outlets Explosion Hazard Do not operate the system in the presence of flammable substances or anaesthetics Radio Frequency Communications Equipment Hazard The use of portable and mobile RF communications equipment in close proximity can affect the operation of medical equipment USER MANUAL abioSCOPE 01 Version EU 1 0 Page 3 39 CE marking This system fulfils the essential requirements of the European Directive 98 79 EC on in vitro diagnostic medical devices as per Annex with the conformity assessment route described in Annex III This Manual This document provides the information needed to setup and operate the abioSCOPE product from Abionic SA Intended Audience This abioSCOPE User Manual is intended to assist physicians medical staff and biomedical engineers who may operate the abioSCOPE system If You Need Assistance If you have questions regarding either the use of the abioSCOPE or the information contained in the accompanying documentation please contact Abionic SA Customer Support at service abionic com On no account should the user attempt to open the device casing The abioSCOPE uses laser components The device casing must not be opened except by the manufacturer or an authorised specialist U
15. mentation cable accessible in order to be able to disconnect the abioSCOPE Also verify that a SD card is correctly inserted into its dedicated slot situated at the top right side of the abioSCOPE next to the touchscreen To turn the abioSCOPE on or off use the On Off switch situated on the rear side of the system Restarting the abioSCOPE In the unlikely event that your system becomes frozen or is not working properly use the following procedure to restart the abioSCOPE e Turn the abioSCOPE off by pressing the On Off button e Wait at least 10 seconds e Turn the abioSCOPE on by pressing the On Off button USER MANUAL abioSCOPE 01 Version EU 1 0 Page 15 39 3 Instruction of Use Principle of detection The principle underlying the abioSCOPE allergy detection system is the biomolecular interaction that occurs in the nanofluidic biosensors contained in the capsules The patient s serum or blood sample containing immunoglobulin E IgE is diluted with a solution composed of fluorescently labeled biomolecules anti IgE The sample is deposited into a capsule where it fills the biosensors inside through capillary action Within the biosensors the biomolecules diffuse interact and form fluorescent molecular complexes The immobilized fluorescent complexes are then optically measured by the abioSCOPE reading unit containing a miniaturized fluorescent microscope The amplitude of the detected fluorescent signal q
16. nauthorised opening of the casing and breaking of the security seal will render the guarantee invalid with immediate effect USER MANUAL abioSCOPE 01 Version EU 1 0 Page 4 39 Safety symbols Note A NOTE provides additional or special information to assist operation Disregarding a NOTE may cause inconvenience but will not result in personal injury or damage to equipment Protective gloves Always wear protective gloves when handling components of the abioSCOPE or abioKIT a because of biological risk Laser beam The abioSCOPE is fitted with a class 1 laser which has the risk of causing permanent eye injury Never open the housing to look into the laser Biological hazard Indicates the presence of hazardous substances that may be infectious The test is performed with human whole blood plasma or serum which may carry a risk of transmitting infectious agents Warning A WARNING is provided in a procedure whenever electrical or mechanical damage may occur Failure to heed a WARNING may result in some form of damage to the equipment or personal injury USER MANUAL abioSCOPE 01 Version EU 1 0 Page 5 39 Content PAG e E 2 Weil E WA AVA CET 3 01046 ZI IA 4 LEM in 4 1 INIRODUGTION cca 7 PDC TS ee 7 CII SCOPE WOT OI EE 7 OS CO Eege 8 CIOS COPE Cl CONG EE 8 NNO E 9 EELER 10 EE 10 2 SYSIEMC COMPONENTS csatcesavsntcssssencsentsanssesevenssesasenesenasencussssaneiasssoassaussentessseepiueeiueacansssonssauasanaresmse
17. neseessapiaansseouns 12 About TAS system ee 12 Olona wall SUD DOLE FINS COO OM ME 13 Total amp specific IGE diagnostic kit ADIOKIT CL content 14 L caling The dbiosCOPE Seria e 15 EE 15 ee 15 amp INSTRUCTION Kei 16 EE ee 16 Pre analysis Drocedure iii 17 ue ee 19 A ARCHIVING AND PRINTING THE RESULTS iii 23 POSE GIGS procede 23 HOMO and Eege 24 5 TESTKITAND STORAGE ca 28 6 ABIOSCOPE CONFIGURATION piu TIRI 29 Entering the Responsible Physician s and user information iii 29 7 TROUBLESHOOTING RE 31 E001 Hardware failure at Startup iii 31 E002 No SD Cord inserted missing SD card ee 32 EPSO 33 E004 Touchbutton is not responding interface software is frozen rei 33 FOOD EEN 34 BOO G IS ge 1S DIE 34 F007 CaP UENEN dE 35 BOOB e a B e CIS SING iaia 36 F009 Progress Eet 37 010 Hardware failure duting meas remenl eege 37 BOLL Wino CTO LO CS CONG NEE 38 E012 Problem of electrical supply iii 38 USER MANUAL abioSCOPE 01 Version EU 1 0 Page 6 39 1 Introduction Intended use The abioSCOPE is a biomedical device that measures specific Immunoglobulin E IgE levels in blood and provides a support for clinical diagnosis of IgE mediated allergic disorders abioSCOPE in vitro tests abioKIT a are designed to deliver quantitative information about patients allergen sensitization at the point of care Protective gloves Always
18. not in use Control that disc tray is closed and turn the abioSCOPE off USER MANUAL abioSCOPE 01 Version 1 0 Page 22 39 4 Archiving and printing the results Post analysis procedure The quantitative results of the test are displayed on the touch screen and saved onto the SD card The user can therefore transfer the results to a computer to print or to store them Abionic s diagnostic tests provide quantitative results on a scale from 3 5 to 500 kU I The results should only be interpreted by a physician Displayed colour bar IgE Concentration kU I IgE Concentration ng ml pe pe pe p E __ p Te USER MANUAL abioSCOPE 01 Version EU 1 0 Page 23 39 Storing and printing results The results are automatically saved onto the SD card that is compatible with most systems Please note that once the HOME is touched or the abioSCOPE is turned off the results are deleted from the abioSCOPE s memory and are then only available on the SD card To transfer store or print the results remove the SD card from abioSCOPE and insert it into your computer s SD card slot If your computer doesn t have one use the USB adapter in option Do not remove SD card after having introduced the patient data SD card can only be removed once the results are displayed Otherwise the measurement date may be lost or corrupted To start the SD card application on your Web browser double click on the file AB
19. pport installation The abioSCOPE may be placed on wall using its dedicated wall support The following instructions indicate how to mount it properly LN Using the screws provided within Dispose the abioSCOPE reader Connect the wall support power the kit fix the support at on the support and immediately supply to an AC source between appropriated height on a wall fix the reader on its support with 100 and 240V the plastic head screw Use only original parts and consumable from Abionic or its agent USER MANUAL abioSCOPE 01 Version EU 1 0 Page 13 39 A aDIONIC Total amp specific IgE diagnostic kit abioKIT a content Each kit is composed of e 1x capsule a e 1x phial of abioMIX reagent b e 1x Point of Care POC blood collector c e 1x test notice not depicted Do not use any of the elements for any other purposes than with the abioSCOPE USER MANUAL abioSCOPE 01 Version EU 1 0 Page 14 39 ian A aDIONIC Locating the abioSCOPE Serial Number The system serial number is printed on a label at the bottom side of the device Unauthorised removal of the label will invalidate your warranty Turning on your abioSCOPE Before starting the abio SCOPE make sure that the system is properly connected to its dedicated power supply and that this is properly connected to an AC source between 100 and 240V The power supply connection is situated on the rear side of the abioSCOPE Keep the ali
20. rDer pi nBos d 4 nGald 1 rAra h 1 Kl Class ok 6 DK 0 34 KULL A 1 2 KWL 1 1 0 KIL 1 60 KUL 5 0 7 KUL D 0 4 KUL 1 0 3 KU L A 0 6 KUL 1 0 1 KUL D 0 5 KUVL 1 Full details about an abioSCOPE s result are displayed on screen in a new tab User can print the result as well as using the QR code to switch to our abioGUIDE mobile application USER MANUAL abioSCOPE 01 Version EU 1 0 Page 27 39 5 Test kit and storage Abionic provides individually packaged abioKIT a for each diagnostic test including the capsule the blood collector and one phial of abioMIX One vial of abioMIX contains 50 ul of detecting reagent which corresponds to the quantity for one analysis one capsule The abioMIX contains a fluorescently labelled anti human IgE antibody at 2 ug mL in phosphate buffered saline supplemented with 0 05 v v of polyoxyethylene 20 sorbitan monolaurate Tween 20 CAS number 005 64 5 The reagent does not contain any preservative and is ready for use Lot number recommended storage condition and expiration date are indicated on the label of the tube The reagent is for in vitro diagnostic use only The kit must be stored in a refrigerated area at 2 6 C Based on lifetime tests the kit s shelf life is estimated at 6 months The user is invited to carefully read the user instruction provided with each abioKIT a Biological hazard Once a capsule has been used it must not be reinserted into the abioSCO
21. rt CDs CD ROMs DVDs or any other media into the abioSCOPE USER MANUAL abioSCOPE 01 Version EU 1 0 Page 36 39 A ADIONIC E009 Progress bar is frozen If the circle progress bar is frozen in the same position for more than 10 minutes restart the abioSCOPE If a test on a capsule has already been started the abioSCOPE will ask for a new capsule to insert If the progress bar repeatedly freezes at the same point in its progression please contact Abionic customer service at service abionic com E010 Hardware failure during measurement If the abioSCOPE experiences a hardware problem during the measurement phase the system will stop and the following error message will appear on screen HardWw are fall LIFE Touch DISC TRAY and follow the instructions displayed on the screen USER MANUAL abioSCOPE 01 Version EU 1 0 Page 37 39 E011 Writing error to a SD card Just before displaying the results the abioSCOPE will write the results data to the SD card If the card is damaged the system will request that a new card is inserted Touch RETRY and follow the instructions displayed on the screen If the problem persists insert a new SD card and touch RETRY E012 Problem of electrical supply If the electrical supply connector is not fully inserted the abio SCOPE may not start after pressing the On Off button In this case check the connector as well as the electrical plug If t
22. s and harmonized documents IEC 61010 1 2001 Safety requirements for electrical equipment IVD IEC 61010 2 101 Safety requirements particular requirements for in vitro diagnostic IVD medical equipment IEC 60825 1 2014 Safety of laser products EN 61326 1 2013 Electrical equipment for measurement control and laboratory use EMC requirements IEC 61326 1 2012 Electrical equipment for measurement control and laboratory use EMC requirements EN 61326 2 6 2013 EMC requirements particular requirements In vitro diagnostic IVD medical equipment IEC 61326 2 6 2012 EMC requirements particular requirements In vitro diagnostic IVD medical equipment EN 301 489 1 Electromagnetic compatibility and Radio spectrum Matters ERM ElectroMagnetic Compatibility EMC standard for radio equipment and services EN 301 489 3 Electromagnetic compatibility and Radio spectrum Matters ERM ElectroMagnetic Compatibility EMC standard for radio equipment and services IEC 62304 2006 Medical device software software life cycle processes ISO 15223 1 2012 Symbols for use in the labeling of medical devices EN 1041 2008 Information supplied by the manufacturer of medical devices The product also complies with the EEC directive 98 79 EC in vitro diagnostic medical devices October 27th 1998 and has received the CE Marking C The product has been developed produced and tested within a Quality Management System
23. uantifies the patient specific IgE levels and thus the patient s allergic sensitization Due to the innovative technology that comprises the nanofluidic biosensor washing and cleaning steps are eliminated and incubation times greatly decreased USER MANUAL abioSCOPE 01 Version EU 1 0 Page 16 39 Pre analysis procedure The following procedure describes the abioKIT a preparation Using the provided POC blood collector take Empty the sample in the POC blood collector in SOul of capillary blood from the patient if the phial filled with the provided abioMIX solution specified whole blood on the abioKIT a package Alternatively it can also be taken 50pl of serum or plasma from the patient USER MANUAL abioSCOPE 01 Version EU 1 0 Shake the closed phial with the solution for at least 10 seconds to mix the patient sample and the abioMIX solution Following tap the phial several times on a hard surface Page 17 39 Insert the open capsule carefully into the abioDISC Using the same pipette extract the solution from the phial using capillary effect and deposit the solution into the central opening in the capsule In order to prevent spilling deposit the entire solution slowly to let the liquid penetrate the capsule USER MANUAL abioSCOPE 01 Version 1 0 Close the capsule by folding over the cover carefully to avoid spilling the solution When placing the abioDISC in the disc tray make sur
24. wear protective gloves when performing tests with the abioSCOPE The abioSCOPE is intended to provide information to medical doctors who are wholly responsible for the interpretation of the test results and for their subsequent decisions abioSCOPE Warranty The abioSCOPE uses laser and high voltage components The device casing must not be opened except by the manufacturer or an authorised specialist Unauthorised opening of the casing and breaking of the security seal will render the guarantee invalid with immediate effect USER MANUAL abioSCOPE 01 Version EU 1 0 Page 7 39 abioSCOPE features e Measurement of specific IgE concentrations displayed on a high resolution touchscreen e Allergy test reports are saved on an SD card in a format that can be opened with any Internet browser abioSCOPE cleaning abioSCOPE cleaning consists in periodically disinfecting the abioSCOPE tray and the abioDISC surfaces with isopropyl alcohol There is no obligation to disinfect the other parts of the system However in order to ensure the correct functionality of the touchscreen it is recommended to clean and disinfect the abioSCOPE surfaces regularly with a standard disinfectant Do not steam sterilize or steam clean as this will damage the device which is not resistant to moisture or heat USER MANUAL abioSCOPE 01 Version EU 1 0 Page 8 39 International conformity The abioSCOPE complies with the following standard
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