Gazelle GZ100 User Manual

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GZL-LBL-0004 r15 Gazelle Diagnostic Device User Manual

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July 4, 2025

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Summary of Contents for Gazelle GZ100

Page 1 GZ100 GZL-LBL-0004 r15 Gazelle Diagnostic Device User Manual...
Page 2 Office No.1208, 12th Floor, Real tech Building, Near vashi station, next to Four Point hotel, MDSS GmbH Bhagwan Mahaveer Rd, Sector 30A, Vashi, Navi Schiffgraben 41 Mumbai, Maharashtra 400703, INDIA 30175 Hannover, Germany GZL-LBL-0004 r15 Gazelle Diagnostic Device User Manual...
Page 3: Table Of Contents
2.2 Status Light Meanings ................................... 18 2.3 Error Messages and Auditory Alerts ............................19 2.4 Touch Screen ....................................19 2.5 Onscreen Keyboards ..................................20 2.6 Toggle Switches and Scroll Buttons ............................. 21 3 Reader Setup ......................................22 GZL-LBL-0004 r15 Gazelle Diagnostic Device User Manual...
Page 4 4.11 Registration of Additional Users and Admins (Optional) ......................44 4.12 Printer Setup (Admins Only) ............................... 46 4.13 Volume and Display Settings (Optional) ............................ 56 4.14 Keyboard Tone .................................... 56 4.15 Register Your Gazelle Diagnostic Device ........................... 57 GZL-LBL-0004 r15 Gazelle Diagnostic Device User Manual...
Page 5 7.4 Transfer Patient Results to a USB Drive ............................74 7.5 Transfer Patient Results to a Computer (Windows 8 and above) ..................... 75 8 Settings Menus ..................................... 76 8.1 USER Settings ....................................77 GZL-LBL-0004 r15 Gazelle Diagnostic Device User Manual...
Page 6 11 Software Updates .................................... 119 12 Maintenance & Cleaning ................................. 120 13 How to Order Supplies ..................................121 14 Symbols ......................................122 15 Contact a Service Representative ..............................123 16 Product Warranty..................................... 124 GZL-LBL-0004 r15 Gazelle Diagnostic Device User Manual...
Page 7: Introduction
The Reader uses magnetic 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 Gazelle Hb Variant test; or fluorescence detection to perform and read results from the Gazelle COVID-19 test.
Page 8: Intended Use
1.3 Device Description The Gazelle Reader is a small, table-top device 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.
Page 9: Principle Of Procedure
Gazelle separates hemoglobin types in a small volume of blood on a piece of cellulose acetate paper that is housed in a cartridge. The basis of Gazelle’s technology lies in hemoglobin electrophoresis, in which different hemoglobin types, including A (normal), S (sickle), C (hemoglobin C disease), A2, E (hemoglobin E disease), and F (fetal) have different net negative charges in an alkaline solution and move across the paper at different speeds due to an applied voltage.
Page 10: Warnings And Precautions
WARNING: Only operate the Gazelle Diagnostic Device for its intended purpose and in accordance with these instructions and warnings. If the Gazelle Diagnostic Device is used in a manner not specified in the Gazelle™ Setup Guide and onscreen Gazelle™ Diagnostic Device User Manual, protection provided by the equipment will be impaired.
Page 11 Reader before moving it. Press and hold the power button until the POWER OFF? screen appears and select YES. CAUTION: If any Gazelle product is dropped, cracked, found to be damaged, or open when received, DO NOT USE. GZL-LBL-0004 r15 Gazelle Diagnostic Device User Manual...
Page 12 CAUTION: Use only the supplies from Gazelle™ Multipacks, Control Kit, or Gazelle PathoCatch™ COVID-19 Test Kit for testing. CAUTION: Do not insert fingers or foreign objects into the Malaria Cartridge chamber of the Reader. CAUTION: Any serious incident that has occurred in relation to this IVD medical device should be reported to the manufacturer and the authority with jurisdiction where the IVD medical device was purchased or used.
Page 13: Materials Shipped With Reader
Wall Adapter & Micro-USB Type B Cable Gazelle™ Setup Guide Gazelle™ Diagnostic Device User Manual (onscreen) 1.8 Associated Products Sold Separately Gazelle™ Malaria Test Multipack M-10 Gazelle™ Malaria Controls Test Kit MC-10 Gazelle™ Hb Variant Test Multipack S-10 GZL-LBL-0004 r15 Gazelle Diagnostic Device User Manual...
Page 14: Calibration And Quality Control Procedures
Malaria Multipack lot as shown on the Gazelle™ Malaria Test Multipack packaging. External COVID-19 Positive and Negative Controls from the Gazelle PathoCatch™ COVID-19 Test Kit should 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.
Page 15 IEC 62262:2002-02 - Degrees of protection provided by enclosures for electrical equipment against external mechanical impacts (IK code) The Gazelle™ Reader complies with the emission and immunity requirements of CISPR 11 Class A, IEC 61326 series emission standards and immunity requirements described in IEC 61326-2-6 The electromagnetic environment should be evaluated prior to operation of the Reader.
Page 16: Gazelle Reader Overview
• Repeatability and reproducibility for the Gazelle™ PathoCatch™ COVID-19 FIA Test was demonstrated with 3 users, 3 Readers, and 1test kit lot across 5 days of testing. • Repeatability for the Gazelle Hb Variant Test was demonstrated using 4 different anticoagulants with 1 multipack lot across 4 days of testing.
Page 17: Power Off And Sleep Modes
• To turn off the Reader when it is not plugged in, press and hold the power button until the POWER OFF? screen appears, and select YES. • To put the Reader in sleep mode (and save power), quickly press and release the power button. GZL-LBL-0004 r15 Gazelle Diagnostic Device User Manual...
Page 18: Status Light Meanings
Sleep Mode; No external power connected and battery fully charged Amber Steady On or Off; Battery Charging Amber Blinking Sleep Mode; Battery Charging Blinking Battery Low or Error* No Light Reader turned off GZL-LBL-0004 r15 Gazelle Diagnostic Device User Manual...
Page 19: Error Messages And Auditory Alerts
All User interactions with the Reader are performed using the touch screen. A typical menu screen (with navigational aids) is shown below. NOTE: The “breather icon” (an icon that pulses off and on) indicates that the Reader is working and responsive. GZL-LBL-0004 r15 Gazelle Diagnostic Device User Manual...
Page 20: Onscreen Keyboards
The Alpha keyboard is initially set to upper case and reverts to lower case after the first key is pressed. Pressing the shift key (↑) switches between upper case and lower-case letters. When the lower-case keyboard is displayed, the ‘ABC’ key appears as ‘abc’. GZL-LBL-0004 r15 Gazelle Diagnostic Device User Manual...
Page 21: 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 the scroll buttons to navigate between fields in a menu or scroll to a specific menu choice, as on the SET TIME & DATE screen. GZL-LBL-0004 r15 Gazelle Diagnostic Device User Manual...
Page 22: Reader Setup
• Insert the supplied cable’s USB Type A (larger) connector into the adapter and plug the supplied wall adapter into a power outlet. • Insert the supplied cable’s micro-USB Type B (smaller) connector into the micro-USB Type B port on the back of the Reader. GZL-LBL-0004 r15 Gazelle Diagnostic Device User Manual...
Page 23 The Reader will automatically power on after it is plugged in. The following screen will appear: GZL-LBL-0004 r15 Gazelle Diagnostic Device User Manual...
Page 24 NOTE: A lightning bolt (charging icon) will appear if the Reader is charging. The number of bars (up to 4) indicates the battery charge status. Battery Legend 100% charged 10% to 99% charged GZL-LBL-0004 r15 Gazelle Diagnostic Device User Manual...
Page 25: Battery Operation
CAUTION. Do not leave the battery uncharged if the status is low or critical. If the battery is left uncharged for several days after falling to 0%, it can take 4 to 5 hours to recharge the battery to the level needed for running a test. GZL-LBL-0004 r15 Gazelle Diagnostic Device User Manual...
Page 26 NOTE: You can check the onscreen user manual for more information if you receive a warning about the battery status. GZL-LBL-0004 r15 Gazelle Diagnostic Device User Manual...
Page 27: Reader Configuration
This menu lets you set the preferred formats for date/time and units of measure. After you have set up your device, a registered Admin can reset these formats by going to (HOME) > (SETTINGS) > ADMIN SETTINGS > LOCAL SETTINGS to bring up this menu. GZL-LBL-0004 r15 Gazelle Diagnostic Device User Manual...
Page 28: Set Time & Date
(SETTINGS) > USER SETTINGS > DATE & TIME to bring up this menu. NOTE: Selecting ‘AM’ or ‘PM’ automatically selects the 12-hour clock. • Use the scroll buttons to make your selections, and press DONE to continue. GZL-LBL-0004 r15 Gazelle Diagnostic Device User Manual...
Page 29 • You should see the following message after selecting DONE key: GZL-LBL-0004 r15 Gazelle Diagnostic Device User Manual...
Page 30: Admin Registration
Reader. • Create an Admin ID and password on the CREATE ADMIN ID AND PASSWORD screen. The default username is ‘Admin’ and the default password is ‘Admin’ (both case sensitive). GZL-LBL-0004 r15 Gazelle Diagnostic Device User Manual...
Page 31 • Press CANCEL on the confirmation screen to return to this step (4.3). CAUTION: Be sure to make a note of both your username and password. Do not share your password with others. Contact your support representative if you have forgotten your Admin password. GZL-LBL-0004 r15 Gazelle Diagnostic Device User Manual...
Page 32: Wireless Configuration
• To enable Wi-Fi, select the Wi-Fi toggle button to set the switch to ON (white background). • Shortly, a list of available Wi-Fi networks will be displayed. Press RESCAN if the desired network does not appear. GZL-LBL-0004 r15 Gazelle Diagnostic Device User Manual...
Page 33 • Select the appropriate network name and enter the password at least 8 characters in length as required by the networks supported by Gazelle. When 8 characters have been entered into the PASSWORD field, the NEXT key will activate (turn orange).
Page 34 • Select NEXT to continue. • Wait for the Reader to connect to the network. You will see a screen similar to the following: GZL-LBL-0004 r15 Gazelle Diagnostic Device User Manual...
Page 35 • 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 with setup. The Wi-Fi connection can be added after the setup is complete by selecting the WIRELESS menu in the USER or ADMIN settings. GZL-LBL-0004 r15 Gazelle Diagnostic Device User Manual...
Page 36: Test Results Access
Registered Admins have access to all patient test results stored on the Reader. You can also determine if all registered Users will have access to all test results or access only to the results of tests they ran. After you have set up your device, a GZL-LBL-0004 r15 Gazelle Diagnostic Device User Manual...
Page 37: Patient Questions
The Patient Questions menu lets you select the patient information you want collected before each test. After you have set up your device, a registered Admin can reset these questions by going to (HOME) > (SETTINGS) > ADMIN SETTINGS > PATIENT QUESTIONS to bring up this menu. GZL-LBL-0004 r15 Gazelle Diagnostic Device User Manual...
Page 38 NOTES: 1. Gazelle comes configured with the following default selections: Patient Last Name, Patient First Name, and Date of Birth. You can remove any of these selections by touching the orange circle. 2. Patient ID will always be a required field for all tests. The AGE field is required for the Hb Variant test.
Page 39: Custom Questions (Optional)
After you have set up your device, a registered Admin can reset these questions by going to (HOME) > (SETTINGS) > ADMIN SETTINGS > CUSTOM QUESTIONS to bring up this menu. NOTE: An entry is required for each custom question. GZL-LBL-0004 r15 Gazelle Diagnostic Device User Manual...
Page 40: Customize Device (Optional)
After you have set up your device, a registered Admin can reset these fields by going to (HOME) > (SETTINGS) > ADMIN SETTINGS > CUSTOMIZE DEVICE to bring up this menu. GZL-LBL-0004 r15 Gazelle Diagnostic Device User Manual...
Page 41 • Enter any other information (such as the address) in ORG FIELD 1, 2, or 3. • Use the orange arrow to scroll to the next entry. • Scroll down to ORG FIELD 3 to enable the NEXT key and continue setup. GZL-LBL-0004 r15 Gazelle Diagnostic Device User Manual...
Page 42: Memory Management
4.9 Memory Management The Gazelle Reader stores up to 2500 patient test results. The Admin can select a method for freeing up memory space that works best for the organization. • Select MANUALLY SELECT TESTS TO DELETE to be notified that memory is full and you need to delete some of the stored test results.
Page 43: Home Menu
At this point, it is recommended that you register other Admins or Users and adjust the volume and brightness settings. See next sections for details. GZL-LBL-0004 r15 Gazelle Diagnostic Device User Manual...
Page 44: Registration Of Additional Users And Admins (Optional)
• Select ADMIN to log into ADMIN SETTINGS. • Log into ADMIN SETTINGS with your ADMIN ID and ADMIN PASSWORD NOTE: Your ADMIN ID can also be accessed from the dropdown menu by pressing next to the ADMIN ID field. GZL-LBL-0004 r15 Gazelle Diagnostic Device User Manual...
Page 45 CAUTION: Admins or Users who forget their password should contact another Admin or a support representative. Hemex recommends assigning the role of Admin to multiple Users to allow for a backup in case an Admin password is forgotten. GZL-LBL-0004 r15 Gazelle Diagnostic Device User Manual...
Page 46: Printer Setup (Admins Only)
HOME menu. 4.12 Printer Setup (Admins Only) Gazelle lets you view and print patient reports from the Reader. The print function is available directly from the Malaria, Hb Variant, or COVID-19 TEST RESULTS screens or from the REPORT VIEW SCREEN.
Page 47 If you set up different printers using Wi-Fi Direct Printing and Computer Based Printing, the last printer configured will be the default. After the printer is set up, it will be available for use every time you start your Gazelle Reader. Wi-Fi Direct Printing Setup CAUTION: To see if this printing method is available for your device, go to HOME >...
Page 48 • Select WI-FI DIRECT PRINTING and NEXT. GZL-LBL-0004 r15 Gazelle Diagnostic Device User Manual...
Page 49 Computer Based Printing Setup – supported on Windows computers only To print to a printer attached a computer that shares the Wi-Fi with the Reader, you will need to install the Gazelle Printer Application on a computer with an attached printer.
Page 50 NOTES: • This application is supported on Windows computers only. • You only need to install the Gazelle printer application on one 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.
Page 51 • The application must be running (in your icon tray) for the printing function to work. • The Gazelle Printer Application must be uninstalled before reinstalling the same or newer version. Click on the tray icon and note the IP address of your computer.
Page 52 • 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 SETUP. GZL-LBL-0004 r15 Gazelle Diagnostic Device User Manual...
Page 53 • Select COMPUTER BASED PRINTING and NEXT. GZL-LBL-0004 r15 Gazelle Diagnostic Device User Manual...
Page 54 • Enter your computer’s IP address as displayed in the 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 on your Gazelle Reader.
Page 55 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 the default setting for your printer. GZL-LBL-0004 r15 Gazelle Diagnostic Device User Manual...
Page 56: Volume And Display Settings (Optional)
HOME menu. 4.14 Keyboard Tone The Reader is set at the factory for audible feedback from the onscreen keyboard. You can turn off or adjust this setting from the USER SETTINGS menu. GZL-LBL-0004 r15 Gazelle Diagnostic Device User Manual...
Page 57: Register Your Gazelle Diagnostic Device
• 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 to https://www.HemexHealth.com/registration, and follow the instructions on the website. GZL-LBL-0004 r15 Gazelle Diagnostic Device User Manual...
Page 58 • 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 the Home menu. GZL-LBL-0004 r15 Gazelle Diagnostic Device User Manual...
Page 59: Logging In And Logging Out
5 Logging In and Logging Out Gazelle Readers employ a system of User and Admin accounts to help ensure security. We recommend having each User log in and log out of each 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.
Page 60: Resetting Passwords
5.3 Logging Out • When you are ready to log out, go to the HOME menu by selecting , and select LOGOUT. NOTES: 1. Users are logged off automatically when the Reader powers down. GZL-LBL-0004 r15 Gazelle Diagnostic Device User Manual...
Page 61 2. Users are NOT logged off automatically when the Reader enters the sleep mode. GZL-LBL-0004 r15 Gazelle Diagnostic Device User Manual...
Page 62: Running A Test (Operating Instructions)
Follow the instructions in the Gazelle PathoCatch™ COVID-19 Test Kit. • If your Reader is enabled for malaria testing, verify the Malaria test operation by running the Gazelle Malaria Positive and Negative Controls. Follow the Gazelle Malaria Positive Control Instructions for Use and Gazelle Malaria Negative Control Instructions for Use in the Gazelle Malaria Test Controls Kit.
Page 63: Go To The Home Menu
Refer to the appropriate test multipack instructions for use to guide you through the steps for running a test. NOTE: The screen will dim slightly while the Hb Variant test is running to save power. Touch the screen to bring it back to normal brightness. GZL-LBL-0004 r15 Gazelle Diagnostic Device User Manual...
Page 64: Creating, Reviewing, Printing, And Transferring Patient Test Reports
7.1 Creating your Customized Report Gazelle’s reporting feature is designed to let you print patient results on plain paper or your inhouse 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.
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Page 68: Find A Patient Report To Review Or Print
Admin has configured the Reader to allow all Users to see all test results. Admins can set this configuration during the initial setup or through ADMIN settings. • From the (HOME) menu, select REVIEW. • Select the appropriate patient type for tests enabled on the Reader, either Hb VARIANT, MALARIA, or COVID-19. GZL-LBL-0004 r15 Gazelle Diagnostic Device User Manual...
Page 69 • 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 first. GZL-LBL-0004 r15 Gazelle Diagnostic Device User Manual...
Page 70 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. GZL-LBL-0004 r15 Gazelle Diagnostic Device User Manual...
Page 71 • To sort by date, select (DATE ) and enter the time period you want to search. GZL-LBL-0004 r15 Gazelle Diagnostic Device User Manual...
Page 72: Display And Print The Patient Report
• 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 menu (Section 7.2), select REPORT VIEWER. GZL-LBL-0004 r15 Gazelle Diagnostic Device User Manual...
Page 73 NOTE: If the Reader is not connected to Wi-Fi, the PRINT button will be grayed out and inactive. To connect to a network, use the WIRELESS menu located under USER or ADMIN Settings. Follow the instructions in Section. 4.4. GZL-LBL-0004 r15 Gazelle Diagnostic Device User Manual...
Page 74: Transfer Patient Results To A Usb Drive
• Insert an OTG compatible USB drive into the micro-USB port in the back of the Reader or use an OTG adapter for other USB drives. GZL-LBL-0004 r15 Gazelle Diagnostic Device User Manual...
Page 75: Transfer Patient Results To A Computer (Windows 8 And Above)
Patient results in PDF format can sent directly to your computers running Windows 8 and above. Go to the printer settings menu on your computer and select PDF printing as the default setting for your printer. GZL-LBL-0004 r15 Gazelle Diagnostic Device User Manual...
Page 76: Settings Menus
8 Settings Menus The Settings menus include settings accessible to all Users and those available only to Admins. To access SETTINGS, press icon. GZL-LBL-0004 r15 Gazelle Diagnostic Device User Manual...
Page 77: User Settings
NOTE: Adjusting the volume slide to the leftmost position turns the sound off. WIRELESS Enables a connection to a wireless network. See Section 4.4 for instructions. When Wi-Fi is enabled and a network with a supported printer has been selected, Patient Reports can be printed. GZL-LBL-0004 r15 Gazelle Diagnostic Device User Manual...
Page 78: Help Menus
8.3 CONTROL TESTS This button gives you access to the positive and negative malaria controls tests. Please see the instructions in the Gazelle Malaria Controls Kit for a complete explanation of how to run these tests.
Page 79 PATIENT These menus let you define the information you want collected from each patient. With Gazelle, QUESTIONS you can select from several pre-defined fields as well as create your own customized questions. Testers will be asked to fill in the patient information for each selected field before running the test.
Page 80 Uers to see all patient test results. MEMORY The Gazelle Reader can store up to 2500 patient test results. The Admin can select a method for MANAGEMENT freeing up memory space before the Reader memory becomes full.
Page 81 The SET TIME & DATE menu lets you set the current date as well as the time using either a 24-hour clock (default) or 12-hour clock. NOTE: Selecting ‘AM’ or ‘PM’ automatically selects the 12-hour clock. • Use the scroll buttons to make your selections, and press DONE to continue. GZL-LBL-0004 r15 Gazelle Diagnostic Device User Manual...
Page 82 SOFTWARE UPDATE Software updates can be downloaded from the Hemex customer resources page: www.HemexHealth.com/crc (Password=GZLC) onto a USB drive on your computer. Select this button to load the update onto the Gazelle Reader. Use an OTG drive (or OTG adapter with drive) when instructed. GPS STATUS Enable the toggle switch to turn on GPS.
Page 83 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 CONFIG Displays the battery gauge (% charged) next to the battery icon. GZL-LBL-0004 r15 Gazelle Diagnostic Device User Manual...
Page 84: Help And Troubleshooting
The HELP menu (which contains this user manual and the support functions) can be accessed by pressing the icon. The SUPPORT menu contains information for contacting support and provides support representatives with access to additional support settings. Only an authorized support representative can access the SUPPORT Settings. GZL-LBL-0004 r15 Gazelle Diagnostic Device User Manual...
Page 85: Troubleshooting Problems With The Reader
Screen buttons are not Dirty Screen Clean Reader screen. See “Maintenance and Cleaning” responsive section for instructions. Lost Password Users or Admins who have forgotten their password should contact another Admin to set up a new GZL-LBL-0004 r15 Gazelle Diagnostic Device User Manual...
Page 86 1. Press power button until Reader screen turns black or white Gazelle Screen off. during startup 2. Wait for LED on the power button to turn off. 3. Press the power button to turn the Reader back on. GZL-LBL-0004 r15 Gazelle Diagnostic Device User Manual...
Page 87 2. Disable and enable Wi-Fi. 3. Press RESCAN, select your network name from the list., and enter password noting case sensitivity. If you are still having trouble, try restarting the Reader and repeat steps 1-3. GZL-LBL-0004 r15 Gazelle Diagnostic Device User Manual...
Page 88 Admins can allow Users to have access to all reports Admins to transfer all PDF patient results through the TEST RESULTS ACCESS reports. Users can only menu in ADMIN settings. transfer the tests they took. GZL-LBL-0004 r15 Gazelle Diagnostic Device User Manual...
Page 89 • Retry printing and wait for successful message printer • Disconnect and reconnect to Wi-Fi • Reconfigure the print function to print to a computer on the network with an attached printer. (See Section 4.12.) GZL-LBL-0004 r15 Gazelle Diagnostic Device User Manual...
Page 90: Troubleshooting A Malaria Or Malaria Control Test
• Review the Instructions for Use Test will not continue after opening Reader will automatically terminate • If door is opened, the Reader door. test when door is opened terminates test, and cartridge should be removed and discarded. GZL-LBL-0004 r15 Gazelle Diagnostic Device User Manual...
Page 91 3. If after three attempts you do not get a satisfactory result, rerun the Malaria Controls. 4. If the controls perform correctly, then the device is functioning properly, and the blood vial may GZL-LBL-0004 r15 Gazelle Diagnostic Device User Manual...
Page 92: Troubleshooting An Hb Variant Or Hb Variant Control Test
Reader can identify problems with the sample preparation, and will display a message with a recommended remedy. To review any aspect of the sample preparation procedure, please view the Gazelle narrated instructional video located on our customer resources page at http://www.HemexHealth.com/crc...
Page 93 Hb Variant image blurry on PDF report Hb Variant window needs cleaning. • Dampen a clean lint free cloth or LCD with deionized water to clean the Hb Variant window in the Hb Variant chamber. GZL-LBL-0004 r15 Gazelle Diagnostic Device User Manual...
Page 94: Troubleshooting A Covid-19 Test
• DO NOT REUSE cartridges for patient testing. • To repeat test, make new sample using new cartridge GZL-LBL-0004 r15 Gazelle Diagnostic Device User Manual...
Page 95: Error And System Messages
This section provides information about error and user messages. NOTE: Messages that are self-explanatory have not been included. For issues concerning power or the battery, please also review Section 3.3 Battery Operation. BATTERY ERRORS Message Explanation GZL-LBL-0004 r15 Gazelle Diagnostic Device User Manual...
Page 96 This message is displayed when the Reader batter is below 1% when the START TEST button is pressed. Plug in the adapter and wait a few minutes until the message disappears to run the test. GZL-LBL-0004 r15 Gazelle Diagnostic Device User Manual...
Page 97 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 your support representative. MEMORY ERRORS GZL-LBL-0004 r15 Gazelle Diagnostic Device User Manual...
Page 98 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. Memory Management of this manual. GZL-LBL-0004 r15 Gazelle Diagnostic Device User Manual...
Page 99 The firmware update will be attempted again after the next power cycle. However, if you see this message more than 3 times in a row when you turn on the Reader, contact your support representative. GZL-LBL-0004 r15 Gazelle Diagnostic Device User Manual...
Page 100 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 this message more than 3 times in a row when you turn on the Reader, contact your support representative. GZL-LBL-0004 r15 Gazelle Diagnostic Device User Manual...
Page 101 If you see this message more than 3 times in a row when you turn on the Reader, contact your support representative. GZL-LBL-0004 r15 Gazelle Diagnostic Device User Manual...
Page 102 Battery is recharging after reaching a low charge state. If the battery was left uncharged for a long time, this process may take a few hours. See Section 3.3 for more information about battery operation. GZL-LBL-0004 r15 Gazelle Diagnostic Device User Manual...
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Page 104 NOTE: Only the COMMENTS field is optional. This message occurs during setup if the Admin selected a Custom Question entry under PATIENT SETTINGS, but then did NOT enter the question in the CUSTOM QUESTION menu. GZL-LBL-0004 r15 Gazelle Diagnostic Device User Manual...
Page 105 This message is displayed when user selects ‘NO’ for infant question or enters a birthdate more than 6 months prior to test (during Hb variant patient info entry) but enters an age less than or equal to 6 months entry. GZL-LBL-0004 r15 Gazelle Diagnostic Device User Manual...
Page 106 This warning occurs if CUSTOM QUESTION 1, (2 or 3) was selected in the PATIENT INFORMATION menu. Enter a question or deselect this option in the PATIENT INFORMATION menu. USB MESSAGES Message Explanation GZL-LBL-0004 r15 Gazelle Diagnostic Device User Manual...
Page 107 Reader or use an OTG adapter for other USB drives. 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. GZL-LBL-0004 r15 Gazelle Diagnostic Device User Manual...
Page 108 1. Unable to transfer data when USB is removed immediately after start of transfer process. 2. Unable to create destination directory to transfer data to USB drive. 3. USB drive is full and data transfer is initiated GZL-LBL-0004 r15 Gazelle Diagnostic Device User Manual...
Page 109 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 MESSAGES Message Explanation GZL-LBL-0004 r15 Gazelle Diagnostic Device User Manual...
Page 110 The maximum number of Users that can be registered on the Reader (99) has been reached A registered Admin must log into ADMIN settings and select EDIT ADMIN to add or update an Admin. GZL-LBL-0004 r15 Gazelle Diagnostic Device User Manual...
Page 111 A registered Admin must log into ADMIN settings and select EDIT USER to add or update a User. GZL-LBL-0004 r15 Gazelle Diagnostic Device User Manual...
Page 112 WI-FI MESSAGES Message Explanation Section 4.4 for instructions. Wi-Fi network may not be available. Try connecting to Wi-Fi again. GZL-LBL-0004 r15 Gazelle Diagnostic Device User Manual...
Page 113 NEW TEST screen, and press RETEST LAST PATIENT. The patient information will be saved. Prepare a new sample. NOTE: In most cases, the Reader can identify problems and will display a message with a recommended remedy. GZL-LBL-0004 r15 Gazelle Diagnostic Device User Manual...
Page 114 1. Ensure that a cartridge was not left in the device before starting a new test. 2. Try restarting the Reader and retesting the sample three times. If you continue to get the message, call your Support Representative. PRINTING MESSAGES Message Explanation GZL-LBL-0004 r15 Gazelle Diagnostic Device User Manual...
Page 115 Warning message that incorrect IP 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 been lost between Gazelle Printer Application and device. Review instructions in Section 4.12.
Page 116: Memory Management
10 Memory Management The Gazelle Reader stores up to 2500 patient test results. The Admin can select a method for freeing up memory space that works best for the organization either at the time of initial setup or at any time by selecting MEMORY MANAGEMENT from the Admin Settings menu.
Page 117 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 will be deleted. GZL-LBL-0004 r15 Gazelle Diagnostic Device User Manual...
Page 118 If you select DELETE DATA BY TEST ID, you can select individual tests to delete. Tests will be in descending order by • time taken. GZL-LBL-0004 r15 Gazelle Diagnostic Device User Manual...
Page 119: Software Updates
Software updates can also be downloaded from the Hemex customer resources page: www.HemexHealth.com/crc (Password=GZLC) onto a USB drive on your computer. Select this button to load the update onto the Gazelle Reader. Use an OTG drive (or OTG adapter with drive) when instructed.
Page 120: Maintenance & Cleaning
Allow the surfaces to air dry. To clean the Hb Variant cartridge slot in the Reader, dampen a clean lint free cloth with deionized water. Clean daily or clean immediately after contamination from patient samples. GZL-LBL-0004 r15 Gazelle Diagnostic Device User Manual...
Page 121: How To Order Supplies
13 How to Order Supplies To order additional supplies, contact your sales representative. GZL-LBL-0004 r15 Gazelle Diagnostic Device User Manual...
Page 122: Symbols
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 batteries. Manufacturer GZL-LBL-0004 r15 Gazelle Diagnostic Device User Manual...
Page 123: Contact A Service Representative
15 Contact a Service Representative Go to www.HemexHealth.com/support for the phone number of the closest support office. GZL-LBL-0004 r15 Gazelle Diagnostic Device User Manual...
Page 124: Product Warranty
HemexDx Pvt. Ltd. Manufactured at: G - 582 - 584, EPIP, Boranada, Jodhpur, Rajasthan, India – 342012 GZL-LBL-0004 r15 Gazelle Diagnostic Device User Manual...