Accellix User manual
Contents
1. ij Accellix Operator Printer Language Offset to GMT Deutsch i EAE 12 53 PM hal ft Figure 4 Settings Page 10 In the Settings page perform the following e Enter the Operator name in the Operator field Note that the operator name appears in the Results page so we recommend you change the operator name if the operator changes e Select a language from the Language list e Set the GMT Offset to define the date and time settings The current time is displayed under the GMT Offset fields e Define a Printer for print jobs This defines where printouts are sent 11 Tap the Home icon tt to return to the home page The device is now ready for use P LeukoDX spc 014 Accellix User Manual Rev 02 Jan 2015 Page 5 of 19 ij Accellix Using the Accellix Diagnostic Device The Accellix device diagnoses cells in a sample which could be blood drawn from a patient or growth media the sample The user inserts the sample into a cartridge which is inserted into the device please see Instructions For Use IFU for the specific cartridge being run 1 Inthe Home page tap of Figure 5 Home Page The process steps 2 7 are displayed by the highlighted gray dots in the bottom of all screens 2 Enter the Patient ID by using the bar code reader or tapping it in on screen The Patient ID will be displayed on all screens until cartridge is removed from device P LeUKOU2. and logistics delays resulting in quicker action and more satisfied patients Intended Use The Accellix platform may be used for a flowcytometric measurement of analytes in biological samples using test specific cartridges intended for use with this instrument Principles of Operation The Accellix platform relying on the general principles of flow cytometry combines fluidics optics and electronics systems in order to measure and analyze optical and fluorescence characteristics of single cells The Flow Cytometer enables complete automation of a 3 step process biochemical sample preparation i e the assay flow cytometry reading and analytical data processing The Accellix platform is designed to enable automatic workflow thus it requires the user to perform only few and simple operational steps Following is a brief description of the mode of operation of the Accellix system e The user selects the assay from the menu displayed on the touchscreen e The user enters the patient ID e The user places a drop of sample in the Assay Cartridge closes the Cartridge Cap inserts the Cartridge to the Reader Instrument and closes the Door P LeukoDx SPC 014 Accellix User Manual Rev 02 Jan 2015 Page 1 of 19 Lj Accellix After closing the Instrument Door the complete assay is automatically executed and the data are analyzed 1 e the system brings the Cartridge into place runs the assay analyzes the results and displays the CD64 i
3. negative controls and data quality checks Automated data analysis providing the user with a final results P LeukoDx SPC 014 Accellix User Manual Rev 02 Jan 2015 Page 17 of 19 Appendix B Symbols 1 Index of Symbols Ce CE Mark DO NOT REUSE z LOT USE BY BATCH CODE MANUFACTURER REP EU Representative g IN VITRO DIAGNOSTIC MEDICAL DEVICE UPPER AND LOWER TEMPERATURE LIMITS CONSULT INSTRUCTIONS FOR USE eE BIOLOGICAL RISKS P LeukoDx SPC 014 Accellix User Manual Rev 02 Jan 2015 Lj Accellix Page 18 of 19 Lj Accellix Appendix C Safety Information e Do not open the device door while the device is processing a sample as it will abort the test This is done to protect the user while the laser is active e For cartridge and assay specific safety issues please refer to the cartridge IFU e Dispose of the cartridge as a biohazard as per local regulations e Electrical safety The instrument meets e IEC EN 61010 2 101 2002 ed 1 Safety requirements for electrical equipment for measurement control and laboratory use Part 2 101 Particular requirements for in vitro diagnostic IVD medical equipment e JEC EN61010 1 2010 e EN61326 EMC emission and immunity requirements P LeukoDx SPC 014 Accellix User Manual Rev 02 Jan 2015 Page 19 of 19
4. X spc 014 Accellix User Manual Rev 02 Jan 2015 Page 6 of 19 ij Accellix Enter Patient ID 51436987 4 is 2 Figure 6 Entering Patient ID 3 Tap Next 4 Extract the cartridge from its bag and scan in the cartridge ID using the bar code reader 5 When the following screen appears insert the sample into the cartridge for further details regarding the sample and the sample loading instructions for a specific test please refer to the Instructions For Use IFU for the test being run and then insert the cartridge into the device ID 51436987 Insert cartridge amp Close Door Figure 6 Instructions How to Insert the Sample and the Cartridge P LeukoDX spc 014 Accellix User Manual Rev 02 Jan 2015 Page 7 of 19 ij Accellix 6 Wait while the screen displays the following message Please wait while cartridge QR code is read and confirmed Please wait while cartidge QR code is read Figure 7 Instruction to Wait While Cartridge Code is Internally Scanned Accellix Confirm Patient ID amp Assay by pressing Next to start test Patient ID 51436987 Assay CD64 Figure 9 Instruction to confirm Patient ID and Assay P LeukoDX spc 014 Accellix User Manual Rev 02 Jan 2015 Page 8 of 19 E S Accellix 7 Tap Next While the device processes and analyzes the sample the following message is displayed Take care not to open the door during processing opening the door will abort the testin
5. cceli g u Are you sure you want to shut down the system Shut Down Figure 15 Shut Down Page 2 Tap Shut Down to shut down To turn the device back on turn the power switch on the rear of the unit to the OFF position and then turn it back to the ON position P LeukoDX sSPC 014 Accellix User Manual Rev 02 Jan 2015 Page 11 of 19 A ccellix Troubleshooting and Maintenance Troubleshooting Computer Issues o User should contact service if the system does not start o User should contact service if the system is out of memory Touchscreen Issues o If touchscreen does not respond the user can operate the system temporarily using a USB connected mouse and keyboard and contact service Internal Instrument Controls and Traceability and Changes in Analytical Performance The Instrument Controls and Traceability are in place via a set of checks performed upon powering up the instrument once a day on a fixed schedule if the instrument is not powered down and up once a day and upon the occurrence of a group 2 error see Error section below This set of self checks includes checking the components required to operate the fully automated system If any such self check detects a component no functioning properly the user will receive an error message that provides information about the failure and instructions to call service Internal assay controls are assay specific and are addressed in the cartridge IFU They include data cont
6. f check This self check program is the same automated procedure which is performed by the instrument automatically upon power up or by automatic scheduling every 24 hours 1f the system is not powered down once a day This self check procedure check a significant number of critical components such as laser detectors cartridge actuation motors and communication between internal components Example of cases where the instrument will request the user to reboot the system to perform self check include e Data controls fail e Laser power is if outside 20 of set point value e Average value of image pixel intensity is below control limit e Acquired file size after acquisition is complete is within 10 of control criteria If the self check is completed successfully the system will request from the user to run another cartridge with the same or a new sample The system may still provide an error message but it could be related to a specific sample that cannot be measured for the test being run Please refer to cartridge IFU for the specific assays being run which provides details about Test Limitations and Interferences such as sample types and medical conditions that may lead to assay failure If the self check fails an error message will provide information about which component is failing the self check test and request the user to contact the manufacturer Specific instructions for each error type are provided on screen as in the examp
7. formed at the manufacturer site according to manufacturing and re work procedures For servicing see Manufacturer information in the beginning of this document or see contact details at www leukodx com e Shipment for service In case shipment for service is required please contact the EU representative or the manufacturer The original packaging is to be saved and stored in a safe place to enable its re use for shipping back to the manufacturer for service In case you consider the instrument to be contaminated please put the instrument in the provided biohazard bag inside the original packaging Cartridge and Assay Specific Issues Cartridge and Assay Specific issues are specific for each assay run on the instrument and are provided in the Instructions for Use IFU provided which each box of assay specific cartridges and available online at www leukodx com The cartridge IFU for each assay provides information about e Measurement Procedure Details e Cartridge and Assay Specific Internal Controls and Traceability and Changes in Analytical Performance The Cartridge and Assay Specific and Traceability and Changes in Analytical Performance are also addressed by the instrument by checking that the data generated in a particular run P LeukoDx SPC 014 Accellix User Manual Rev 02 Jan 2015 Page 15 of 19 _ Accellix meets a certain number of data quality checks Further information is provided in the Instructions for Use IFU provided w
8. g process Please wait while assay completes Time Remaining 1 42 Figure 10 Time to Test End When processing is complete a results page appears similar to the following CD64 Index 0 68 Figure 81 Results Page 8 Tap Next or If desired tap fay to go the page designed print the results If no printer is connected it will give a message P LeukoDX spc 014 Accellix User Manual Rev 02 Jan 2015 Page 9 of 19 amp Accellix Microsoft XPS Document Writer Fax East Wing Figure 92 Choosing Printer 9 Open the door and remove the cartridge when the following message is displayed Ty ad 1 Open Door 2 Remove Cartridge 3 Close Door Figure 13 Instruction to Open Door and Remove Cartridge 10 Dispose of the cartridge as a biohazard according to local regulations O Aou a Please wait while current test terminates Figure 14 Shown immediately after an abort or failure It is displayed while the system returns to initial positions so the cartridge can be removed this can take some time depending on how quickly the assay s script can be aborted and where all the motors are LeuUKO SPC 014 Accellix User Manual Rev 02 Jan 2015 Page 10 of 19 ij Accellix Shutting Down the Device The device can be left on and there is no need to shut it down regularly If you do wish to shut it down T 1 In the Home page tap 0 A confirmation query appears oe k
9. instrument d LeukoDx SPC 014 Accellix User Manual Rev 02 Jan 2015 Page 14 of 19 Lj Accellix e Connection to customer LAN Wi Fi network or Printer should be performed by qualified IT personnel Connection to customers LAN should be with less than 3 meters cable Please contact LeukoDx service department to obtain information regarding how to perform such operation e Cleaning the System The Accellix cytometer may need to be cleaned from time to time In order to maintain the integrity of all of the Accellix components the following cleaning procedure can be used wipe off the device with a cloth or wipe saturated in isopropyl alcohol IPA or an isopropyl alcohol mix Examples of appropriate cleaning solutions include CaviWipes and Purisept spray and wipes The device should be cleaned according to the directions provided with the cleaning solution e Decontamination In case of minor spill from a cartridge proceed with decontamination using alcohol according to your institution handling procedure for materials that have been in contact with blood All blood products should be treated as if they may potentially contain pathogens e Disposal Procedure The instrument should be disposed of according to local regulations in place for electronics and medical equipment Dispose of used cartridges as a biohazard according to local regulations e Service Manual No servicing is to be performs at the user site All servicing is per
10. ith each box of assay specific cartridges e Calibration The instrument self checks ensure that the functionality of the instrument is tested If calibration is required for a certain cartridge or assay type the details of the nature and frequency of the calibration needed to ensure that the device operates properly and safely will be described in the IFU for such cartridge P LeukoDx SPC 014 Accellix User Manual Rev 02 Jan 2015 Page 16 of 19 Lj A ccellix Appendix A Technical Specifications Instrument Description Specification Use conditions Ambient Temperature 15 C 32 C Non Condensing Max Rel Humidity 85 Protect the system from direct sunlight humidity and dust Focus and Alignment of Optical platform Real time focus and excitation alignment utilizing proprietary image analysis control algorithm DAQ A D Resolution Sampling Rate 14 bit 100 KHz Software LeukoDx custom software running on Windows 7 embedded 64 bit operating system Assay automation Motor control of 7 assay motors Auto focus Auto alignment Three reagent injection Sample Mixing Sample Reading Sample type Sample volume Sample Assay Specific see relevant cartridge IFU Limitations Assay automation Assay Specific General capabilities are Three reagent injection steps one temperature controlled Each step enables mixing and incubation time automated sample reading Assay specific integrated positive and
11. le below P LeukoDx SPC 014 Accellix User Manual Rev 02 Jan 2015 Page 13 of 19 ij Accellix CD64 ee ID 51436987 Accellix lt Error Error 32 Error moving motor 0 A fatal error occurred You may either 1 Run a System Check to try and clear the error or 2 Shut down the device and Contact manufacturer System Check _ Figure 17 Example of Group 2 Error Page Handling Handle the instrument with care Protect the system from direct sunlight humidity and dust Environmental operation conditions Ambient Temperature 15 C 32 C Non Condensing Max Rel Humidity 85 For information on instrument dimensions and power refer to Appendix A Technical Specifications Control Method Control methods and means to verify performance within specifications are in inherent to the different assay cartridges and respective data processing Further information is provided in the Instructions for Use IFU provided which each box of assay specific cartridges and available online at www leukodx com Maintenance Maintenance the instrument is maintenance free the user only needs to follow instructions provided by errors messages See Troubleshooting and Error Messages section below This instrument is classified as a Class 1 Laser product according to IEC 60825 1 edition 3 The instrument uses internally a 50mW 488nm Class 3B Laser The user customer technician should never open the
12. mj Accellix p LeukoDx Co A CCCLUX User Manual SPC 014 Version 2 0 January 2015 Copyright 2014 LeukoDx Ltd All rights reserved Accellix is a trademark of LeukoDx Ltd All trademarks used herein are the property of their respective owners P LeukoDx SPC 014 Accellix User Manual Rev 02 Jan 2015 wl Manufacturer Information LeukoDx Ltd Tel 972 2 674 4422 Fax 972 2 674 4455 E mail office leukodx com 3 HaMarpe St 3rd Floor AVX Building Har Hotzvim Jerusalem 9777403 Israel EC REP EU Representative Information Medpace Medical Device B V Maastrichterlaan 127 129 NL 6291 EN Vaals Tel 31 43 306 3320 Fax 31 43 306 3338 Table of Contents RRC ROC DTE OEI AA P A A OEI TO I A AA UniS oo US e A E E E Pinciples OF Operace E Overview of Operating Elements sesccccccccccccccccccccccccccecccccececccccccccccccceccecccccccccccceceeee First Time PMS CAAT ON sineira E aE Oie Using the Accellix Diagnostic DeviCe ssssssssssccccccccccccssssssssccccccecccccccossssssscssccecceseosoo UCI Down the DG VIC 0 ssesscsiissneiai narn E Troubleshooting and Maintenancce cccccccccccccssssssssssssssssssssssssssccccccccccssssssssssssees OTN OU INE O oa E E E S Appendix A Technical Specifications ccccccsssssssssscsscccccccccccccccsssssssssssssssecees POAC BD Sy NOS aa E Appendix C Safety MilOr mato nis siceccssssicsccscssessssccdcecsassvsvsssceteccsusssevsessedencsss
13. ndex e The Cartridge Handling Unit returns the Cartridge to start position and the Cartridge can be removed The GUI prompts the user to remove the Cartridge from the Reader Instrument and to discard it as a biohazard Overview of Operating Elements The Accellix platform is a diagnostic system composed of a tabletop Flow Cytometer and a single use disposable Assay Cartridge The Accellix Cytometer is mainly operated through the touchscreen and attached barcode reader Detailed description and functional specifications of the Assay Cartridge are provided in the Cartridge Instructions For Use IFU Cartridge Figure 1 The Accellix platform Flow Cytometer and Cartridge The Assay Cartridge is shown here upon insertion into the Flow Cytometer p LeukoDX spc 014 Accellix User Manual Rev 02 Jan 2015 Page 2 of 19 hj Accellix First Time Installation 1 Unpack the package and verify it contains e The Accellix device e A power cable e A bar code reader e A biohazard bag to enable shipment of a contaminated instrument The original packaging is to be saved and stored in a safe place to enable its re use for shipping back to the manufacturer for service 2 Place the device on a clean flat and stable surface 3 Connect one end of the power cable to 100 220V AC 50 60Hz power source with the supplied power cable and the other end to the power outlet at the rear of the Accellix unit In areas with power disturbances or t
14. o ensure test completion in case of power outage it is recommended to connect the instrument to the power via an UPS that can provide 300VA or higher for amount of time of 20 minutes not supplied with the instrument RJ 45 port USB ports Power switch Power socket Figure 1 Rear of Accellix Unit 4 Connect the bar code reader to a USB port at the rear of the Accellix unit 5 Optionally connect an Ethernet network cable to the RJ 45 port at the rear of the Accellix unit This enables connectivity to a network Alternatively connect a local printer to one of P LeukoDx SPC 014 Accellix User Manual Rev 02 Jan 2015 Page 3 of 19 ij Accellix the USB ports on the rear of the device if Internet is available to the device so the printer s driver can be downloaded See Maintenance section regarding connecting to a network or installing drivers 6 Optionally connect a keyboard not supplied to a USB port on the rear of the unit This is not mandatory because you can use the device on screen keyboard 7 Turn on the device by switching the Power switch at the rear of the unit to ON The following message appears on screen Performing System Self check Please Wait Figure 2 System Self Check 8 Verify that the system completes initialization and the Home page appears Figure 3 Home Page 9 Tap Settings to access the Settings page P LeukoDX sSPC 014 Accellix User Manual Rev 02 Jan 2015 Page 4 of 19
15. rols to verify data integrity and maintained analytical performance per each run Traceability The internal control materials were developed based on a fluorescence bead suspension traceable to the NIST Standard Reference Material SRM 1932 RM 8640 Error Messages Error Message are classified in two groups Group 1 errors Recoverable errors The system detects that an operation failed and it can be recovered Examples of recoverable errors are The system does not recognize the cartridge barcode or a patient ID and asks the user to extract the cartridge and insert it again or request the user to enter a patient ID manually If a certain operation fails repeatedly the system will move to Group 2 error after a certain number of attempts Specific instructions for each error type are provided on screen as in the example below P LeukoDx SPC 014 Accellix User Manual Rev 02 Jan 2015 Page 12 of 19 ij Accellix ID 51436987 Error 1205 Failed to read Cartridge ID Discard cartridge and repeat with new cartridge Figure 16 Example of Group 1 Error Page Group 2 errors Recoverable errors requiring instrument self check The system detects that an operation failed but the failure may be connected to a specific cartridge or a specific patient sample Before proceeding with repeating the test with another cartridge the system will provide an error message about which test condition failed and request from the user to perform a sel
16. ssessscesbessss P LeukoDX spc 014 Accellix User Manual Rev 02 Jan 2015 Lj Accellix Introduction Accellix is an affordable tabletop diagnostic device with single use assay cartridges that does not require extensive training nor involve complex operational processes Accellix dramatically expands access to flow cytometry capabilities by replacing previously complex testing with a user friendly automated instrument that can be used by any medical practitioner nursing staff or junior lab tech on a 24 7 basis Health practitioners get rapid results that previously required sending samples out to a central lab Accellix eliminates that transport time wait times at the lab and other delays that may directly lead to degradation in patient health and effective treatment The Accellix platform s fast and user friendly interface facilitates simple and reliable analysis using disposable cartridges for sepsis tests Accellix is mainly intended for e Hospitals with time critical departments ICU ER OR neonatal ward Nurses on location can run tests eliminating long waits and queues at a central lab e External Third party run hospital labs Simple automated tests are available 24 7 to all the lab s staff not just senior specialists This eliminates wait time for batch processing and tests can be run and returned quickly proving especially useful for high priority cases e Clinics and Doctors Accellix drastically reduces test travel
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