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Gazelle GZ100 User Manual Download Page 2

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GZL-LBL-0004 r15 Gazelle Diagnostic Device User Manual

HemexDx Pvt. Ltd.

Registered Office Address:
Office No.1208, 12th Floor, Real tech Building,
Near vashi station, next to Four Point hotel,
Bhagwan Mahaveer Rd, Sector 30A, Vashi, Navi
Mumbai, Maharashtra 400703, INDIA

MDSS GmbH
Schiffgraben 41
30175 Hannover, Germany

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Summary of Contents for GZ100

Page 1: ...1 GZL LBL 0004 r15 Gazelle Diagnostic Device User Manual GZ100...

Page 2: ...l HemexDx Pvt Ltd Registered Office Address Office No 1208 12th Floor Real tech Building Near vashi station next to Four Point hotel Bhagwan Mahaveer Rd Sector 30A Vashi Navi Mumbai Maharashtra 400703...

Page 3: ...ecautions 10 1 7 Materials Shipped with Reader 13 1 8 Associated Products Sold Separately 13 1 9 Calibration and Quality Control Procedures 14 1 10 Specifications 14 2 Gazelle Reader Overview 16 2 1 P...

Page 4: ...Admin Registration 30 4 4 Wireless Configuration 32 4 5 Test Results Access 36 4 6 Patient Questions 37 4 7 Custom Questions Optional 39 4 8 Customize Device Optional 40 4 9 Memory Management 42 4 10...

Page 5: ...the Controls Tests to Verify Operation 62 6 4 Go to the HOME menu 63 6 5 Fill in the Patient Questions 63 6 6 Run the Test 63 7 Creating Reviewing Printing and Transferring Patient Test Reports 64 7...

Page 6: ...with the Reader 85 9 3 Troubleshooting a Malaria or Malaria Control Test 90 9 4 Troubleshooting an Hb Variant or Hb Variant Control Test 92 9 5 Troubleshooting a COVID 19 Test 94 9 5 Error and System...

Page 7: ...c field technology in conjunction with a photodetector to perform and read results from the Gazelle Malaria test cellulose acetate electrophoresis technology to perform and read results from the Gazel...

Page 8: ...that reads test results from proprietary single use test kits cartridges that use one of 3 technologies miniaturized electrophoresis fluorescent or visual lateral flow and magneto optical detection Fo...

Page 9: ...t different speeds due to an applied voltage The different hemoglobin types separate into visible bands on the paper The image analysis algorithm extracts the image characteristics of the hemoglobin b...

Page 10: ...arker The result Malaria Detected or Malaria Not Detected is displayed on the screen after about one minute 1 5 Warnings and Precautions WARNING Do not disassemble or attempt to repair the Reader as t...

Page 11: ...e spills from the surface of the Reader See Section 12 Maintenance Cleaning for instructions CAUTION It is recommended that the battery be fully charged before first use Use the micro USB power adapte...

Page 12: ...rect sunlight as this may cause a result of TEST PROBLEM ENCOUNTERED requiring a retest using new materials WARNING Follow proper infection control guidelines for handling all specimens and related it...

Page 13: ...from SARS CoV 2 not for any other viruses or pathogens This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vi...

Page 14: ...hould be run with each new kit Hb Variant Marker Fluid from the Gazelle Hb Variant Test Multipack serves as a control for each Hb Variant test WARNING Materials should only be used before their stated...

Page 15: ...ssion standards and immunity requirements described in IEC 61326 2 6 The electromagnetic environment should be evaluated prior to operation of the Reader WARNING Do not use this device in close proxim...

Page 16: ...n Conditions Reader transportation temperature range 25 C to 60 C 13 F to 140 F Reader transportation relative humidity range 5 to 95 Altitude Up to 3000 meters 9842 feet Precision Repeatability and r...

Page 17: ...OWER OFF screen appears and select YES The charging screen will appear for 1 minute before the screen goes blank The power button remains lit showing the charging status described in the next section...

Page 18: ...ader powers down 2 Users are NOT logged off automatically when the Reader enters sleep mode CAUTION Before moving the Reader press and hold the power button until the POWER OFF screen appears and sele...

Page 19: ...t will notify the User with an error message and auditory alert beep The status light will turn red and blink The Help and Troubleshooting section of this user manual lists the error messages that may...

Page 20: ...ard appear on specific screens to enable User input CAPITALIZATION The Alpha keyboard is initially set to upper case and reverts to lower case after the first key is pressed Pressing the shift key swi...

Page 21: ...text and number entry 2 6 Toggle Switches and Scroll Buttons To enable a toggle switch such as Wi Fi select the switch so that the background turns white and the orange circle moves to the right Use...

Page 22: ...issing or if there are obvious signs of damage to the Reader or components 3 2 Power Up and Battery Charge CAUTION The battery should be fully charged using the adapter before first use A fully draine...

Page 23: ...23 GZL LBL 0004 r15 Gazelle Diagnostic Device User Manual The Reader will automatically power on after it is plugged in The following screen will appear...

Page 24: ...eader s self test After the self test has completed the battery icon will appear on the top right of the LOCAL SETTINGS menu NOTE A lightning bolt charging icon will appear if the Reader is charging T...

Page 25: ...uation plugging in the adapter will bring up the DEVICE DEEP CHARGE message The message will stay on the screen until the Reader reaches sufficient charge which takes about 30 seconds to a minute When...

Page 26: ...26 GZL LBL 0004 r15 Gazelle Diagnostic Device User Manual NOTE You can check the onscreen user manual for more information if you receive a warning about the battery status...

Page 27: ...eone who will be a designated Admin NOTES 1 FACTORY RESTORE may only be performed by a qualified support representative 2 An Admin can change any of these settings after setup by going to the ADMIN se...

Page 28: ...urrent date as well as the time using either a 24 hour clock default or 12 hour clock After you have set up your device any registered User can reset the time and date by going to HOME SETTINGS USER S...

Page 29: ...29 GZL LBL 0004 r15 Gazelle Diagnostic Device User Manual You should see the following message after selecting DONE key...

Page 30: ...nd date again after setup by going to the User Settings Section 8 1 If you still notice a discrepancy contact your service representative 4 3 Admin Registration The Reader requires at least one Admin...

Page 31: ...word Press NEXT to continue You will be reminded to write down your username and password Press CANCEL on the confirmation screen to return to this step 4 3 CAUTION Be sure to make a note of both your...

Page 32: ...ckup in case an Admin password is forgotten 4 4 Wireless Configuration When Wi Fi connections are enabled patient reports can be printed on supported printers You can access the WIRELESS CONNECTION me...

Page 33: ...ported by Gazelle When 8 characters have been entered into the PASSWORD field the NEXT key will activate turn orange Selecting the icon allows you to view the characters as you type them NOTE The firs...

Page 34: ...34 GZL LBL 0004 r15 Gazelle Diagnostic Device User Manual Select NEXT to continue Wait for the Reader to connect to the network You will see a screen similar to the following...

Page 35: ...i icon will appear on the top banner If there is an issue with the Wi Fi connection the screen below will be displayed Select the CONTINUE key disable the Wi Fi Wi Fi toggle switch to OFF and continue...

Page 36: ...Reader The Reader will only connect to password protected networks open and hotel networks are not supported Select DONE on the WIRELESS CONNECTION menu to continue 4 5 Test Results Access Registered...

Page 37: ...gistered Users to see all patient test results OR to limit registered Users to see only the results of tests they ran Select DONE to continue 4 6 Patient Questions The Patient Questions menu lets you...

Page 38: ...riant test 3 Users must provide an input for all patient entry fields before starting a test Only the COMMENTS field if selected may be left blank Use the scroll buttons to navigate through all three...

Page 39: ...DEVICE menu will appear 4 7 Custom Questions Optional If you selected QUESTION 1 2 or 3 on the PATIENT QUESTIONS menu the ENTER CUSTOM QUESTIONS menu will be displayed After you have set up your devi...

Page 40: ...the keypad to enter your custom questions and once all question fields are entered press the highlighted NEXT key to continue 4 8 Customize Device Optional The information entered in this menu will b...

Page 41: ...ries are optional Enter your facility or laboratory name in the ORGANIZATION field Enter any other information such as the address in ORG FIELD 1 2 or 3 Use the orange arrow to scroll to the next entr...

Page 42: ...ct MANUALLY SELECT TESTS TO DELETE to be notified that memory is full and you need to delete some of the stored test results Recommended Select AUTOMATICALLY OVERWRITE TESTS if you want the Reader to...

Page 43: ...the HOME menu 4 10 Home Menu From the HOME menu you can run the tests enabled on your Reader Hb Variant COVID 19 and or Malaria review patient reports go to the settings menus or log out At this poin...

Page 44: ...ditional up to 99 Users and Admins to operate Gazelle NOTE Only a registered Admin can add delete or change other User or Admin passwords From the HOME menu select to go to the SETTINGS menu Select AD...

Page 45: ...Reader Select EDIT ADMINS and then ADD ADMIN to register additional Admins on the Reader CAUTION Admins or Users who forget their password should contact another Admin or a support representative Heme...

Page 46: ...y from the Malaria Hb Variant or COVID 19 TEST RESULTS screens or from the REPORT VIEW SCREEN See Section 7 3 You can print out patient reports from the Reader in three different ways Wi Fi Direct Pri...

Page 47: ...T PRINTING setting is not visible on this screen then this method is not available for this device Please use the COMPUTER BASED PRINTING REQUIRES GAZELLE PRINTER APPLICATION method instead Wi Fi must...

Page 48: ...48 GZL LBL 0004 r15 Gazelle Diagnostic Device User Manual Select WI FI DIRECT PRINTING and NEXT...

Page 49: ...e a message that reads Configuration Successful The printer will now be automatically ready for use each time you turn on your Gazelle Reader Press CONTINUE to return to the PRINTER SETUP screen Press...

Page 50: ...e computer on the shared network It can service up to 256 Gazelle devices Wi Fi must be enabled on the Reader and a network connection established as described in Section 4 4 Download the Gazelle Prin...

Page 51: ...ll appear in your icon tray NOTES AND CAUTIONS The Gazelle Printer Application will launch each time you start your computer The application must be running in your icon tray for the printing function...

Page 52: ...LBL 0004 r15 Gazelle Diagnostic Device User Manual From the HOME menu select to go to the SETTINGS menu Log into the ADMIN menu admins only Scroll to the bottom of the menu selections and select PRINT...

Page 53: ...53 GZL LBL 0004 r15 Gazelle Diagnostic Device User Manual Select COMPUTER BASED PRINTING and NEXT...

Page 54: ...he Gazelle Printer Application complete with periods and select NEXT You should see a message that reads Printer Setup Successful The printer will now be automatically ready for use each time you turn...

Page 55: ...tic Device User Manual NOTE You can also send PDFs directly to your computer to be stored supported on Windows 8 and above Go to the printer settings menu on your computer and select PDF printing as t...

Page 56: ...locate the VOLUME BRIGHTNESS menu Tap the scroll buttons to adjust the slider bars to the desired levels NOTE Adjusting the volume slide to the leftmost position turns the sound off Select DONE to re...

Page 57: ...go to the SETTINGS menu Select USER Select KEYPAD TONE Select DONE to return to the SETTINGS menu or select to return HOME menu 4 15 Register Your Gazelle Diagnostic Device To register your device go...

Page 58: ...0004 r15 Gazelle Diagnostic Device User Manual To turn off the Keypad Tone switch the toggle key to the off position as shown in the figure Adjust the volume using the slider bar Press to return to th...

Page 59: ...h testing session to prevent unauthorized use 5 1 Log In After the Reader has been configured a login screen will appear each time the Reader is turned on The usernames for all registered Admins and U...

Page 60: ...OME menu select to go the SETTINGS menu Select ADMIN and log in using your Admin login and password To reset a User password select EDIT USER and then UPDATE Select the User from the list of registere...

Page 61: ...61 GZL LBL 0004 r15 Gazelle Diagnostic Device User Manual 2 Users are NOT logged off automatically when the Reader enters the sleep mode...

Page 62: ...y doing the following If your Reader is enabled for Hb Variant testing verify the Hb Variant test operation by running a control test using an Hb Variant Cartridge Marker Fluid and Buffer with a sampl...

Page 63: ...croll buttons next to each field to move to the next screen NOTES 1 An Admin can revise the selection of Patient Information screens from Admin Settings HOME SETTINGS ADMIN SETTINGS PATIENT QUESTIONS...

Page 64: ...stationery and to set the information fields you want included Gazelle will customize the reports according to the fields you set during the initial setup or later by a registered Admin From the SETT...

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Page 66: ...66 GZL LBL 0004 r15 Gazelle Diagnostic Device User Manual...

Page 67: ...67 GZL LBL 0004 r15 Gazelle Diagnostic Device User Manual...

Page 68: ...can only review the results of patients they tested unless the Admin has configured the Reader to allow all Users to see all test results Admins can set this configuration during the initial setup or...

Page 69: ...9 GZL LBL 0004 r15 Gazelle Diagnostic Device User Manual Scroll through the menu to find the patient for review using either the Patient ID or Date of Test The most recent test results are listed firs...

Page 70: ...70 GZL LBL 0004 r15 Gazelle Diagnostic Device User Manual Data Sort To narrow your search you can sort on TEST ID or DATE To sort by test ID select TEST ID and enter the range you want to search...

Page 71: ...71 GZL LBL 0004 r15 Gazelle Diagnostic Device User Manual To sort by date select DATE and enter the time period you want to search...

Page 72: ...c Device User Manual Select the report you want to review or print by touching the associated circle 7 3 Display and Print the Patient Report After selecting a patient to review on the PATIENT REVIEW...

Page 73: ...go back to the REVIEW PATIENT menu to select another patient to review or select to return to the HOME menu NOTE If the Reader is not connected to Wi Fi the PRINT button will be grayed out and inactiv...

Page 74: ...the HOME menu select REVIEW Select either MALARIA Hb VARIANT or COVID 19 patient type depending on the test s enabled on your Reader and your desired test type then select NEXT Scroll through the men...

Page 75: ...OTES 1 A copy of the selected test results will remain in Reader memory 2 File names on the USB directory are formatted as follows Malaria tests MOD_ device serial number _ Test ID _ Date _ Time Hb Va...

Page 76: ...GZL LBL 0004 r15 Gazelle Diagnostic Device User Manual 8 Settings Menus The Settings menus include settings accessible to all Users and those available only to Admins To access SETTINGS press the ico...

Page 77: ...orrect and select the DONE key to continue with the Reader setup CAUTION If you notice a discrepancy between the time and date stamp on the screen and the settings you entered try resetting the time a...

Page 78: ...ria Controls Kit for a complete explanation of how to run these tests 8 4 ADMIN Settings The ADMIN Settings menus allow the Admin to configure the Reader Use the scroll buttons to page through the sel...

Page 79: ...from Admin Settings HOME SETTINGS ADMIN SETTINGS PATIENT QUESTIONS 2 Users must provide an input for each patient entry field before starting a test Only the COMMENTS field may be left blank 3 If the...

Page 80: ...ou can view or print the selected test results from the REPORT VIEWER NOTE Registered Users can also see any test result depending upon the setting in the RESULTS ACCESS menu See below RESULTS ACCESS...

Page 81: ...laboratory name in the ORGANIZATION field Enter any other information such as the address in FIELDS 1 2 and 3 Use the arrows to scroll through ALL the questions then press the highlighted NEXT key to...

Page 82: ...ader See Section 7 4 REGISTER DEVICE Reminder to Admin to go to www HemexHealth com register to register your device Follow the instructions on the website to create an account DEVICE CONFIG Provides...

Page 83: ...SETUP Configures a default printer directly connected to the shared Wi Fi with the Reader or connected to a computer sharing the Wi Fi with the Reader for printing reports See Section 4 12 BATTERY CON...

Page 84: ...oting problems with the Hb Variant or Hb Variant Controls Tests Troubleshooting problems with COVID 19 Tests Description of error messages 9 1 The HELP menu The HELP menu which contains this user manu...

Page 85: ...t Once the steps listed below are executed if the situation persists contact your Support Representative and provide the Reader serial number test ID and test date READER QUESTIONS Description Possibl...

Page 86: ...hen the battery gauge on the screen shows 2 charge you will be able to run a test See Section 3 3 for a description of battery operation Reader will not turn on when wall adapter connected Press the p...

Page 87: ...STIONS Description Possible Cause Next Steps Cannot find your Wi Fi network on the Reader wireless connection list Open and hotel networks are not visible in the Reader menu Reader will only connect t...

Page 88: ...lected Wi Fi network USB COMMUNICATIONS Description Possible Cause Next Steps USB Transfer not working USB thumb drive or wall adapter cable problem Use new USB drive or USB adapter cable User unable...

Page 89: ...Check that the Reader is connected to the correct Wi Fi network Check that a printer or a computer with a printer are available on network Review the printer setup instructions in Section 4 12 Printe...

Page 90: ...r when you do not receive the expected results for a test MALARIA TEST AND MALARIA CONTROL TEST QUESTIONS Description Possible Cause Next Steps One or both Malaria Control tests failed Cartridge Failu...

Page 91: ...1 Obtain new patient sample and retest 2 Test Reader using Malaria Controls 3 Check to see if diluent or multipack has expired Malaria test displays Test Problem Encountered message Patient sample too...

Page 92: ...ting suggestions for when you do not receive the expected results for a test In most cases the Reader can identify problems with the sample preparation and will display a message with a recommended re...

Page 93: ...uching screen will bring display back to normal brightness Reader freezes during Hb Variant test Reader issue Rerun test If repeated contact support for assistance No Hb Variant test image on display...

Page 94: ...9 Test The following section provides troubleshooting suggestions for when you do not receive the expected results for a test In most cases the Reader can identify problems with the sample preparation...

Page 95: ...prepared NOTE The message will give additional information on the problem Check orientation of the cassette If cassette was inserted properly review test procedure and rerun the test 9 5 Error and Sy...

Page 96: ...apter before the Reader powers down Occurs when Reader charge falls below 1 during a test Once the test has completed you will have one minute to plug in the adapter before the Reader powers down This...

Page 97: ...vice User Manual Disconnect the adapter to allow the battery to cool down Occurs when the battery charge is at 9 or below Recommend connecting adapter for uninterrupted operation Battery fail Contact...

Page 98: ...iagnostic Device User Manual Message Explanation This message occurs if you have opted to delete test results manually when memory is full For instructions on deleting test results see Section 10 Memo...

Page 99: ...er note the hardware error number and contact your support representative This message usually occurs due to a problem with the internet connection The firmware update will be attempted again after th...

Page 100: ...n a row when you turn on the Reader contact your support representative If you see this message more than 3 times in a row when you turn on the Reader contact your support representative If you see th...

Page 101: ...101 GZL LBL 0004 r15 Gazelle Diagnostic Device User Manual If you see this message more than 3 times in a row when you turn on the Reader contact your support representative...

Page 102: ...T screen and press RETEST LAST PATIENT The patient information will be saved Prepare a new sample BATTERY MESSAGES Message Explanation Battery is recharging after reaching a low charge state If the ba...

Page 103: ...103 GZL LBL 0004 r15 Gazelle Diagnostic Device User Manual...

Page 104: ...e marked on the PATIENT QUESTIONS screen must be filled in by the tester otherwise a warning message is displayed NOTE Only the COMMENTS field is optional This message occurs during setup if the Admin...

Page 105: ...age is displayed when user selects NO for infant question during Hb variant patient info entry but enters an age less than or equal to 6 months entry This message is displayed when user selects NO for...

Page 106: ...me of the person who ordered the test NOTE This is an optional field selected by the Admin This warning occurs if CUSTOM QUESTION 1 2 or 3 was selected in the PATIENT INFORMATION menu Enter a question...

Page 107: ...to get this error contact your Support Representative Insert an OTG compatible drive into the micro USB port in the back of the Reader or use an OTG adapter for other USB drives Insert an OTG compatib...

Page 108: ...and insert a USB drive This message occurs if a patient test file is corrupted Warning message when 1 Unable to transfer data when USB is removed immediately after start of transfer process 2 Unable...

Page 109: ...e Diagnostic Device User Manual When the message no longer appears it is safe to remove your USB drive When the message no longer appears it is safe to remove your USB drive USER ADMIN REGISTRATION ME...

Page 110: ...aximum number of Admins 99 that can be registered on the Reader 99 has been reached The maximum number of Users that can be registered on the Reader 99 has been reached A registered Admin must log int...

Page 111: ...111 GZL LBL 0004 r15 Gazelle Diagnostic Device User Manual A registered Admin must log into ADMIN settings and select EDIT USER to add or update a User...

Page 112: ...112 GZL LBL 0004 r15 Gazelle Diagnostic Device User Manual WI FI MESSAGES Message Explanation See Section 4 4 for instructions Wi Fi network may not be available Try connecting to Wi Fi again...

Page 113: ...TING MESSAGES Message Explanation May occur when running the Covid Hb Variant or Malaria tests Remove the cartridge or cassette continue to the NEW TEST screen and press RETEST LAST PATIENT The patien...

Page 114: ...than normal to allow the Reader to analyze the sample If this message occurs during testing 1 Ensure that a cartridge was not left in the device before starting a new test 2 Try restarting the Reader...

Page 115: ...address of the desktop with the Gazelle Printer Application was entered during printer setup process for computer based printing Review instructions in Section 4 12 Warning message that connection has...

Page 116: ...ESTS TO DELETE to be notified when memory is full so that you can manually delete some of the stored test results Select AUTOMATICALLY OVERWRITE TESTS if you want the Reader to automatically overwrite...

Page 117: ...04 r15 Gazelle Diagnostic Device User Manual Your screen will present the enabled test types If you select MALARIA TEST DATA Hb VARIANT TEST DATA or COVID 19 TEST DATA all test results of that type wi...

Page 118: ...118 GZL LBL 0004 r15 Gazelle Diagnostic Device User Manual If you select DELETE DATA BY TEST ID you can select individual tests to delete Tests will be in descending order by time taken...

Page 119: ...Reader is connected to Wi Fi the notification will appear when the Reader is first turned on and when you are logged in to ADMIN SETTINGS The update can be initiated from the notification Software up...

Page 120: ...with the bleach solution making sure that no excess fluid drips from the cloth Wipe all accessible exterior surfaces of Reader so they are moist including under the lid Allow the surfaces to air dry T...

Page 121: ...121 GZL LBL 0004 r15 Gazelle Diagnostic Device User Manual 13 How to Order Supplies To order additional supplies contact your sales representative...

Page 122: ...azelle Diagnostic Device User Manual 14 Symbols Warning or Caution Biological Hazard If disposal of the Reader is necessary follow local guidelines for disposing non reusable devices with lithium ion...

Page 123: ...123 GZL LBL 0004 r15 Gazelle Diagnostic Device User Manual 15 Contact a Service Representative Go to www HemexHealth com support for the phone number of the closest support office...

Page 124: ...nty coverage from the date of receipt by customer Fluids and other consumables are warranted through their expiration date Warranties are not transferable from the original purchaser Warranty coverage...

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