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BioNote Vcheck M10 User Manual Download Page 2

      

   VCM751EA

VCM752EA

VCM753EA

Doc. No.: IM751-1E(CE)

Issued date : 2022-11-21

Authorized Representative 

Altenhofstrasse 80 D-66386 St. Ingbert Germany

Tel: +49-6894-581020   l   Fax: +49-6894-581021

Manufactured by 

Head office

C-4th&5th, 16, Deogyeong-daero 1556beon-gil, Yeongtong-gu, Suwon-si, 

Gyeonggi-do, 16690, Republic of Korea

Manufacturing site

74, Osongsaengmyeong 4-ro, Osong-eup, Heungdeok-gu, Cheongju-si, 

Chungcheongbuk-do, 28161, Republic of Korea

Tel: +82-31-300-0400   l   Fax: +82-31-300-0499 

www.sdbiosensor.com

Distributed by 

             

22, Samsung 1-ro 4-gil, Hwaseong-si, Gyeonggi-do, 18449, Republic of Korea

Tel: +82-31-211-0516   l   Fax: +82-31-8003-0618

www.bionote.co.kr

Summary of Contents for Vcheck M10

Page 1: ...FOR VETERINARY USE ONLY USER MANUAL ...

Page 2: ...th 16 Deogyeong daero 1556beon gil Yeongtong gu Suwon si Gyeonggi do 16690 Republic of Korea Manufacturing site 74 Osongsaengmyeong 4 ro Osong eup Heungdeok gu Cheongju si Chungcheongbuk do 28161 Republic of Korea Tel 82 31 300 0400 l Fax 82 31 300 0499 www sdbiosensor com Distributed by 22 Samsung 1 ro 4 gil Hwaseong si Gyeonggi do 18449 Republic of Korea Tel 82 31 211 0516 l Fax 82 31 8003 0618 ...

Page 3: ...is user manual and the instructions included in each test cartridge package before using the analyzer In addition please familiarize yourself with the necessary preparation and the procedures For further inquiries about the analyzer please contact your local dealer Product demonstrations can be found at www bionote co kr ...

Page 4: ... 1 Intended Use 11 2 Product Overview 11 3 Components of Vcheck M10 12 4 Software GUI Description 14 5 Components 15 6 Specifications 16 7 Unpacking 16 8 Precautions Before Measurement 17 Log On and Setting 1 Initial Setup 18 1 1 Installation 1 2 Analyzer LogIn 1 3 Analyzer Status Light 1 4 Analyzer Settings CHAPTER 1 CHAPTER 2 CHAPTER 3 TABLE OF CONTENTS ...

Page 5: ... 3 Review 41 CHAPTER 4 QC 1 QC Test 42 Cleaning and Maintenance 1 Analyzer Cleaning 45 2 Maintenance and Transportation 45 Warning Info Error Messages 1 Warning Messages 46 2 Info Messages 47 3 Error Messages 49 CHAPTER 5 CHAPTER 6 CHAPTER 7 ...

Page 6: ...tient Scan Apply Sample Sample Scan Insert Cartridge Sample Scan Insert Cartridge Cartridge Check Cartridge Scan Cartridge Check Scan Scan Select Summary Summary Amplification Amplification Details Details General Date Time Volume Install Laguage Patient Registration Brigthness Auto Logout Early Call Update Result List Network HIS LIS Login User Module Select ...

Page 7: ...h Indicates the OFF position of the main power switch Indicates the ON OFF position of the main power switch Safety Symbols Symbols Description Caution Indicates a situation which if not avoided could result in damage to the analyzer or incorrect results Indicates the presence of a laser inside the analyzer and to proceed with appropriate caution Environmental Symbols Symbols Description WEEE cros...

Page 8: ... with care Fulfills the requirements of Electro Magnetic Compatibility Directive 2014 30 EU Low Voltage Directive 2014 35 EU Indicates to keep the analyzer dry that you should keep the analyzer dry EU Representative Temperature limit Humidity limitation Abbreviations Abbreviations Description Comm Communication LIS Laboratory Information Systems HIS Hospital Information System GUI Graphic User Int...

Page 9: ...be installed where the power supply and power switch are easily accessible and easily disconnectable Installing the analyzer in an inappropriate location such as where the system cannot be easily disconnected from the power supply may cause fire or lead to a serious damage to the system 10 Use an approved adapter 11 For accurate result please refer to the instruction manual provided with each cart...

Page 10: ...ital regulations Specimens must be considered as potential biohazards If you have no experience in specimen collection and handling procedures you must receive appropriate training or guidance Nitrile latex gloves are recommended when handling specimens 4 Warranty and Free Warranty Period Service Policy 1 ThefreewarrantyperiodofVcheckM10Systemis2yearsfromthedateofproductinstallation In the case of...

Page 11: ...ridge packages 2 Product Overview The Vcheck M10 is a real time PCR analyzer which automatically performs nucleic acid extraction and amplification and detection of the target sequences in various specimens Vcheck M10 is a closed system which is only used with BIONOTE Vcheck M cartridge This Vcheck M10 analyzer consists of the Vcheck M10 Module and the Vcheck M10 Console The entire PCR process is ...

Page 12: ...ode reader Used for scanning specimen IDs and cartridges barcodes C Speaker Audio output location D USB port Used for connecting with keyboard printer and USB memory E Power switch Used for turning on off the Console F D sub cable port Used for connecting console and module using D sub cable G LAN port Used for communicating through the local area network H AC power port Used for connecting AC Pow...

Page 13: ...an filter mounted on the vent that discharges heat to the outside E Air Intake Filter Cover Cover for replacing the filter mounted on the external air intake F Mini USB port USB port for developers for FW update not for users H D sub cable port Used for connecting console and module using D sub cable J AC power port Input port to connect power K Power switch Used to turn the Module on off L AC pow...

Page 14: ... status of wired LAN connection 2 USB Indicate the status of USB connection 3 CAL CAL Indication alarm recommending calibration 4 Home Move to the Home screen 5 Setting User setting 6 Review Check accumulated results 7 User Indicate user s name 8 Log Out User Log out 1 2 3 4 5 7 6 8 ...

Page 15: ... Module Item Appearance Description Gender Connect AC power D sub between modules AC cover Terminate AC power of module block the user contact Bracket Connect upper side of the modules AC power cable Connect AC power of module 3 Accessory Item Appearance Description D sub cable Connect D sub between console and module Side Bracket Connect modules which located up and down ...

Page 16: ...iquid media Technology Silica technology Operation Syringe air pressure Temperature control Temperature rise speed 3 5 sec From 60 to 95 Temperature drop speed 3 0 sec From 95 C to 60 C Accuracy 0 5 Uniformity 0 3 7 Unpacking Unpack the analyzer on a clean level and stable surface The air vents on the analyzer are on the back These vents must not be blocked when installing the analyzer Avoid placi...

Page 17: ...ear gloves and follow other relevant health and safety regulations Operating Conditions To correctly operate the Vcheck M10 please follow the guidelines below The Vcheck M10 system must be operated in the permitted temperature range Since the range is different for each test please refer to the manual of the test cartridge suitable for the specific test To perform a test on the Vcheck M10 system p...

Page 18: ...sub cable at the back of the Vcheck M10 Console and Vcheck M10 Module to link them together Connect the supplied AC power cable to the Vcheck M10 Console and the Vcheck M10 Module respectively Connect the power cord of AC cable to a power outlet B A C A Vcheck M10 Module power cable AC power cable B Vcheck M10 Console power cable AC power cable C Communication cable D Sub cable ...

Page 19: ... additional M10 Modules Connect the M10 Modules using the bracket and screws supplied with M10 Module Bracket Connect the supplied gender at the back of the M10 Module 1 and M10 Module 2 to link them together 2 1 Gender ...

Page 20: ...20 2 2 Installing additional M10 Modules Connect multiple modules using bracket and side bracket Bracket Side Bracket ...

Page 21: ...o create a virtual keyboard Login ID is admin and password is 1111 Change the password of admin account at initial log on for further security Click the input box to create a virtual keyboard After entering the ID and password press the Log in button to enter the Home screen ...

Page 22: ...nincorrectIDorpassword the icon may turn red and the warning pop up may appear Ifyouloginsuccessfully aninstallation will proceed automatically Theinstalledmodulesarerecognizedin the order in which they are connected ...

Page 23: ...23 1 3 Analyzer Status Light State Red Yellow Indication Not connected Installing LED sign State Blue Green Indication Connected Running LED sign ...

Page 24: ...10 Module and the number of M10 Module recognized on UI are different Please check the connection cables or gender Re installation Procedure Only the admin account is able to proceed this task Click the install button on the Settings menu to proceed During the process the yellow LED light may flash If the problem continues check the connection between the console and modules Turn off all power at ...

Page 25: ...ting the admin s password it is very recommended to be noted While running the assays the Update Install and Network functions are blocked as these functions may affect the results For details of the Settings menu refer to the following Stage Menu Sub Menu 1 General Date Time Language Brightness Volume Patient ID Early Detection Call Auto Logout Install USB Registration Update 2 User Add Edit Dele...

Page 26: ...26 1 Select on the main menu screen to enter the Settings menu 2 Settings menu consists of General User and Network ...

Page 27: ... when performing a test Early Detection Call If you use the Early Detection Call function you can check the positive result while running Install If the number of modules changes or there are issues with initial auto installation please proceed with the re installation USB Registration For cyber security only admin account can register or unregister the USB memory stick by using the Register butto...

Page 28: ...an be registered edited and deleted 5 If you click the input box a keyboard will appear In User category the password is same as the Password when you logged in 6 In User category you can add an Operator ID by clicking the Add New button ...

Page 29: ...29 Enter the ID and password to be added Click the Add button If the password is incorrect the Please check password will appear ...

Page 30: ...ed will appear Make sure that PW consists of 8 to 15 characters including numbers and lowercase letters 7 To edit the Operator ID select the ID to be modified Press button on the Edit screen After modifying the ID and password click the Edit button ...

Page 31: ...he ID to be deleted and press button Then press the OK button on Delete screen 9 In Network category you can set the Network of HIS LIS and analyzer Set the network IP Netmask Gateway Port of the M10 Console Apply it through the Save button ...

Page 32: ... currently used Protocol has Off HL7 LAW methods Select the desired communication method among them After that click the Save button to apply the desired results If Off is selected the result data for the patient will not be transmitted even if the Auto send function is activated ...

Page 33: ...ndow will appear When you click Import the crt file in the USB memory will install the certificate into the M10 Console When you click Export the certificate in the M10 Console is saved as a USB memory address the top path of the inserted USB memory Certificate sddev crt Check the certificate regarding the designated person and the issuer M10 Self Signed ...

Page 34: ... the patient to the server applying the set protocol and security When set to On the setting is activated For example if protocol HL7 setting and Security Off are set the patient s test result is transmitted to the server without security through HL7 communication ...

Page 35: ... to the analyzer Is the set date and time on the analyzer correct Have you checked the analyzer settings 1 Run Test 1 By selecting button you can check the progress status of M10 on the Main screen Depending on the operation status of M10 the progress status is displayed as Running Completed Available ...

Page 36: ... or Available status can be operated 3 Scan the barcode of the sample or manually type the sample ID If the input is successful it automatically moves to the next step Before starting the test remove any cartridges or materials inside the module If not a pop up will appear asking you to remove it ...

Page 37: ...lly moves to the next step 5 Inject the specimens into the test cartridge Then touch the screen or wait 9 seconds Place the cartridge in the M10 Module immediately Close the M10 Module door manually Refer to Procedure in the assay specific Vcheck M Cartridge instructions for further details ...

Page 38: ... the M10 Module the next screen will be displayed Select OK to proceed or select Reset to restart 7 It automatically checks the surface temperature of the cartridge and the proper operation of the optical module After that the test proceeds ...

Page 39: ...39 8 When the assay is completed the M10 Module Door opens automatically Once the operation is completed remove the used cartridge immediately Dispose of as biohazardous waste and dispose of immediately ...

Page 40: ...sults 1 You can check the summary of a result in the Summary tab Pathogen IC Valid 2 You can check the target amplification graph for each item in the Amplification tab Result Ehrlichia Anaplasma Result Ehrlichia Anaplasma Ehrlichia Anaplasma Result ...

Page 41: ...etailed result information in the Details tab 3 Review You can check the accumulated test results in Review You can check the detailed results of each test Pathogen IC Valid Babesia gibsoni Babesia canis 22 94 Ct 24 94 Ct ...

Page 42: ... the set date and time on the analyzer correct Have you checked the analyzer settings Is the QC control solution ready 1 QC Test 1 By selecting button you can check the progress status of M10 on the Main screen Depending on the operation status of M10 the progress status is displayed as Running Completed Available ...

Page 43: ... or Available status can be operated 3 The barcode of the specified QC Solution should be scanned If the barcode of the QC to be tested is recognized it automatically moves to the next stage If you scan the QC barcode provided by the BIONOTE the QC check box is automatically checked ...

Page 44: ...44 4 The next step will be proceeded the same as the Run Test 5 If the test is completed the result will be recorded in Review If you click the QC filter you can review only QC results ...

Page 45: ...of 1 propanol 2 propanol and glutaraldehyde trade name Bacillol plus Do not use abrasive cloth or antiseptic solution as this may damage the display screen Always turn off the analyzer and remove the power cable before cleaning 2 Maintenance and Transportation If there is any problem on the Vcheck M10 system the Console automatically shows what went wrong for each time the system is powered on Be ...

Page 46: ... ID or Password Wrong ID or password is input Solution Input the correct ID or password Warning Cartridge Not Found The door is closed but there is no cartridge inserted Solution Open the door and insert the cartridge to re test Warning The update file could not be found There is no update file in USB Solution Check if there is an update file on the USB If you confirm that there is an update file ...

Page 47: ... the M10 Module click the OK button Warning Not registered USB The USB memory stick inserted into the M10 Console is not registered Solution In the order of Setting USB Registration Register register the use of USB memory 2 Info Messages Indication Info Description Information Check updates Solution Check for updates Information Check if M10 Module is reinstalled Solution Check for reinstall ...

Page 48: ...ormation Have no crt file in USB memory Solution Copy the certificate file crt you want to install into the USB memory and try again Information Please eject all USB memory sticks then Then re insert it Solution This is an alarm when trying to register USB security After removing all USB memory insert it again and proceed registering USB security Information Please reboot M10 Console Solution It i...

Page 49: ...xpired Error Temperature Error The cartridge temperature is out of Solution The analyzer and the inspection cartridge are moved within an appropriate temperature range and the test is performed Do not artificially heat or cool the analyzer Error Operation module Angle Encoder Error While operating the cartridge in the M10 problem occurred in the operation of lower angle motor Solution If error occ...

Page 50: ...Total number turn off the power of M10 Console and M10 Module and check if the cable and gender are properly connected Error Operation module operation error Error occurring in M10 motor operation module Solution Turn off the power of M10 Console and M10 Module and check if the cable and gender are properly connected Error Optic module operation error Error in M10 Optical Measurement Module Soluti...

Page 51: ...dule information Connect UI number and it must be identical to the number of physically installed M10 Solution If the Connect number is displayed differently from the Total number turn off the power of M10 Console and M10 Module and check if the cable and gender are properly connected Error Network setting is not properly completed The setting of network related to the Network and LIS of M10 Conso...

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