Gazelle GZ100 User manual

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GZL-LBL-0004 r15 Gazelle Diagnostic Device User Manual
GZ100

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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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GZL-LBL-0004 r15 Gazelle Diagnostic Device User Manual
Contents
1 Introduction............................................................................................................................................................................................7
1.1 About this User Manual ..................................................................................................................................................................7
1.2 Intended Use....................................................................................................................................................................................8
1.3 Device Description...........................................................................................................................................................................8
1.4 Principle of Procedure ....................................................................................................................................................................9
1.5 Warnings and Precautions ...........................................................................................................................................................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 Power Off and Sleep Modes.........................................................................................................................................................17
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

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3.1 Inspection and Placement ............................................................................................................................................................22
3.2 Power Up and Battery Charge......................................................................................................................................................22
3.3 Battery Operation..........................................................................................................................................................................25
4 Reader Configuration ..........................................................................................................................................................................27
4.1 Local Settings .................................................................................................................................................................................27
4.2 Set Time & Date .............................................................................................................................................................................28
4.3 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 Home Menu .................................................................................................................................................................................43
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

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5 Logging In and Logging Out ................................................................................................................................................................59
5.1 Log In ..............................................................................................................................................................................................59
5.2 Resetting Passwords .....................................................................................................................................................................60
5.3 Logging Out....................................................................................................................................................................................60
6 Running a Test (Operating Instructions)............................................................................................................................................62
6.1 Ensure the Reader is Set Up Correctly for the Test....................................................................................................................62
6.2 Assemble Materials .......................................................................................................................................................................62
6.3 Run 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
7.1 Creating your Customized Report ...............................................................................................................................................64
7.2 Find a Patient Report to Review or Print.....................................................................................................................................68
7.3 Display and Print the Patient Report...........................................................................................................................................72
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

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8.2 HELP Menus ...................................................................................................................................................................................78
8.3 CONTROL TESTS ............................................................................................................................................................................78
8.4 ADMIN Settings..............................................................................................................................................................................78
9 Help and Troubleshooting ..................................................................................................................................................................84
9.1 The HELP menu .............................................................................................................................................................................84
9.2 Troubleshooting Problems 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 Messages .........................................................................................................................................................95
10 Memory Management.....................................................................................................................................................................116
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

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GZL-LBL-0004 r15 Gazelle Diagnostic Device User Manual
1 Introduction
Your Gazelle Reader is enabled with one or more of the following test capabilities:
•Hb Variant
•COVID-19
•Malaria
The enabled tests will be shown on the HOME page.
The Gazelle Test System is comprised of the following components:
•Gazelle Reader, and
•Gazelle Malaria test or
•Gazelle Hb Variant test, or
•COVID-19 test
The Gazelle Reader is a small, table-top, in vitro diagnostic instrument that works with Gazelle proprietary, single-use
disposable cartridges to perform a test. 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.
See the applicable Cartridge Package Insert for the Intended Use for the test.
1.1 About this User Manual
This Gazelle™ Diagnostic Device User Manual is intended to be a comprehensive source of information for setup, settings, error
messages, maintenance tips and troubleshooting tips. The Reader also comes with a Gazelle™ Setup Guide sheet for
instructions on setting up the Reader upon unboxing. The instructions for use inserts included with the Hb Variant Test

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Multipack, Gazelle PathoCatch™ COVID-19 Test FIA Kit, Malaria Test Multipack, and Malaria Controls Test Kit contain
instructions for running each test.
This Gazelle™ Diagnostic Device User Manual can also be downloaded from the customer resources page at:
http://www.hemexhealth.com/crc (Password=GZLC).
1.2 Intended Use
The Gazelle™Reader is an in vitro diagnostic device intended for the qualitative or quantitative detection of components
indicative of infectious disease, metabolic, or physiologic conditions. It uses miniaturized electrophoresis, fluorescent and
visual lateral flow, and magneto-optical detection methods, depending on the test cartridge used. The device is intended for
professional use in a healthcare point-of-care or laboratory setting.
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.
For some tests, the Reader provides a quantitative test result, while other test results are qualitative.
The Reader can be used in challenging environments that may be warm (operating temperature range 5°C to 45°C) or high in
humidity (operating relative humidity range 5% to 95%) and operates on a built-in lithium-ion battery. The Reader can be
charged using the standard micro-USB wall adapter provided.
The Reader has internal data storage to keep a record of test results. From the Reader, Users can print test results to a Wi-Fi
connected printer or to a printer connected to a Wi-Fi accessible computer.
The Gazelle Reader allows remote software updates to ensure operation with the latest testing algorithms. Administrators
are automatically notified about software updates when the Reader is connected to the internet via Wi-Fi and can choose to
upgrade the software if desired.

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1.4 Principle of Procedure
The information below describes the principle of procedure for those tests enabled on your reader.
Microchip electrophoresis: Gazelle Hb Variant uses a miniaturized version of the gold standard test for hemoglobinopathy
detection known as electrophoresis. When a disposable cartridge (from the Hb Variant Test Multipack) containing a lysed
blood sample (20 µL) is inserted into the Reader, the hemoglobin types are separated according to their charge. In about 8
minutes, the interpretation (normal, trait, disease) as well as the types and percentages of hemoglobin are displayed on the
screen and stored digitally.
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. The
different hemoglobin types separate into visible bands on the paper. The image analysis algorithm extracts the image
characteristics of the hemoglobin bands to determine the type of hemoglobin as well as its relative amount. This information
is used to offer an interpretative statement based on hemoglobin proportions.
COVID-19 Fluorescent immunoassay: Gazelle works in conjunction with the Gazelle PathoCatch™ COVID-19 Test Cassette’s
fluorescent immunoassay technology to detect COVID-19. The Gazelle™ PathoCatch™ COVID-19 Test Cassette for SARS-CoV-2
antigen employs immunofluorescence technology in a sandwich design that is used with the Gazelle Reader to detect SARS-
CoV-2 nucleocapsid protein. The nucleocapsid protein in the nasal sample combines with the fluorescently labeled SARS-
CoV-2 antibody to form a complex, which is subjected to chromatography. The complex moves forward through the
nitrocellulose membrane to the SARS-CoV-2 detection line (T line). The complex is captured by the SARS-CoV-2 antibody-
coated detection line to form the final reaction, making the detection line (T line) visible to the Gazelle Reader. An internal
procedure control band will appear at the control line (C line) region for each test if the test was conducted properly.

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Magneto-optical detection: Gazelle Malaria operates by detecting the biomarker hemozoin, a by-product of all malaria
parasite species, in a small (30 µL) blood sample. A disposable cartridge (from the Malaria Test Multipack) containing a
diluted blood sample is inserted into the Reader. The diluted blood sample is lysed in the Reader using ultrasonic energy to
release the hemozoin. Hemozoin is paramagnetic and aligns when exposed to an intense magnetic field, but in a low
magnetic field, the hemozoin orientation is random. A light beam is passed through the sample while the sample is exposed
to alternating high and low magnetic fields. Since more light is blocked when hemozoin is aligned than when the orientation
is random, changes in light passing through the sample are indicative of the presence of hemozoin –a malaria biomarker.
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 there is a risk of harm to the Reader and the
User. This Reader does not contain User serviceable parts. Disassembling the Reader will void the warranty and
the Reader may not perform properly.
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. The Gazelle Diagnostic Device is designed to operate within the manufacturer’s specifications. Do not
exceed the manufacturer specifications when in use.
WARNING: Operators should familiarize themselves with the Warnings and Precautions provided in the
Gazelle™ Setup Guide or this onscreen Gazelle™ Diagnostic Device User Manual before proceeding with the test.

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WARNING: Do not use the Reader in close proximity to sources of strong electromagnetic radiation (e.g.
unshielded intentional RF sources), as these can interfere with proper operation.
WARNING: This Reader contains a lithium ion battery. Keep the Reader away from heat greater than the
operating temperature and fire.
WARNING: Materials should only be used before their stated expiration dates.
CAUTION: For in vitro diagnostic use only.
CAUTION: Clean all sample 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
adapter that is provided with the Reader, as charge time may be impacted by a third-party adapter. Third-party
adapters should be CE approved. NOTE: EMI performance with third-party adapters will degrade.
CAUTION: Do not move the Reader while a test is in progress. To avoid damage to the Reader, power down the
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.

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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.
CAUTION: Do not perform the COVID-19 test in direct 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 items. Wear
personal protective gloves while handling samples and change gloves between testing each specimen. If the
gloves come in contact with specimen or appear to be wet, change gloves to avoid contamination. Change
gloves before leaving work area and upon entry into work areas.
Properly dispose of all contaminated waste.
WARNING: If disposal of the Reader is necessary, follow local guidelines for disposing non-reusable devices
with lithium ion batteries.
USA FDA Warnings and Precautions for the Gazelle™ PathoCatch™ COVID-19 FIA Test

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CAUTION: USA Federal law restricts this device to sale by or on the order of a licensed healthcare practitioner.
•For Use Under An Emergency Use Authorization Only.
•This test is only for in vitro diagnostic use only.
•For Prescription Use Only.
•This test has not been FDA cleared or approved.
•This test has been authorized by FDA under an EUA for use by authorized laboratories and at the point of
care.
•This test has been authorized only for the detection of nucleic acid 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 vitro diagnostic tests for detection and/or diagnosis of COVID-19
under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the
authorization is terminated or revoked sooner.
1.7 Materials Shipped with Reader
Gazelle™ Reader GZ-100
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

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Gazelle™PathoCatch™ COVID-19 FIA Test Kit made by Mylab Discovery Solutions MGPF25
Gazelle™ PathoCatch™ COVID-19 FIA Test Kit made by Mylab Discovery Solutions MGPF025
1.9 Calibration and Quality Control Procedures
The Gazelle Reader is factory calibrated and does not require any further calibration. The Hb Variant cartridges, COVID-19
cassettes, and Malaria cartridges do not require calibration.
External Malaria Positive and Negative Controls from the Gazelle™ Malaria Controls Test Kit should be run with each new
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.
WARNING: Materials should only be used before their stated expiration dates.
1.10 Specifications
Safety and Regulatory Compliance
The Gazelle™ Reader has been tested and found to be in compliance with applicable requirements of the following safety
and electromagnet standards:
IEC 60601-1-2 Edition 4.0:2015 Medical electrical equipment –Part 1-2: General requirements for basic safety and essential
performance –Collateral Standard Electromagnetic disturbances -Requirements and tests
IEC 61010-1:2010. Safety Requirements for Electrical Equipment for Measurement, Control and Laboratory Use –Part 1:
General Requirements
IEC 61010-2-101:2015. Safety Requirements for Electrical Equipment for Measurement, Control and Laboratory Use –Part 2-
101: Particular requirements for in vitro diagnostics (IVD) medical equipment

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IEC 61326-1:2012. Electrical Equipment for Measurement, Control and Laboratory Use –EMC requirements –Part 1: General
Requirements
IEC 61326-2-6:2012. Electrical Equipment for Measurement, Control and Laboratory Use –EMC requirements –Part 2-6:
Particular Requirements –In vitro diagnostics (IVD) medical equipment
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.
WARNING: Do not use this device in close proximity to sources of strong electromagnetic radiation (e.g.,
unshielded intentional RF sources), as these may interfere with proper operation
The Gazelle™ Reader complies with mechanical requirements of IEC 61010-1 with IEC 62262 degree of protection code IK05
READER SPECIFICATIONS
Color Touch Screen
•7”
Data storage
•Reader stores up to 2500 patient test results
•Results can be transferred via USB to other devices
Power
Requirements
•Line power for wall adapter: 100-240 VAC, 50-60Hz; 0.3A
•The provided external adapter supplies 5V DC to the Reader
Dimensions
•14.5cm x 20cm x 26cm (5.7 inches x 7.9 inches x 10 inches)

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Weight
•2.75 kg (6 pounds)
Operating and
Storage Conditions
•Reader storage temperature range: -25°C to +60°C (-13°F to +140°F)
•Reader operating temperature range: +5°C to +45°C (-45°F to +113°F)
•Reader operating and storage relative humidity range: 5% to 95%
Transportation
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 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.
2 Gazelle Reader Overview

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2.1 Power Off and Sleep Modes
•To turn on the Reader, press the power button.
•To turn off the Reader when it is plugged in, press and hold the power button until the POWER 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).
•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.

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•If left unattended for 15 minutes, the Reader will automatically revert to sleep mode. Tap the screen, press the power
button, or lift the lid to return to active operation.
•If left unattended for 30 minutes, the Reader will automatically power down.
NOTES:
1. Users are logged off automatically when the Reader 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 select YES.
2.2 Status Light Meanings
Color
State
Meaning
Green
Steady
On; Sleep Mode; External power connected
and a fully charged battery
Green
Blinking
Sleep Mode; No external power connected
and battery fully charged
Amber
Steady
On or Off; Battery Charging
Amber
Blinking
Sleep Mode; Battery Charging
Red
Blinking
Battery Low or Error*
No Light
Reader turned off

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*See “Help and Troubleshooting”in this guide for more information.
2.3 Error Messages and Auditory Alerts
Whenever the Reader encounters a condition that prevents continued operation (such as a critically low battery or open lid
during a test), it 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 be displayed along with their
remedies.
2.4 Touch Screen
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.

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2.5 Onscreen Keyboards
An Alpha Keyboard and Numeric Keyboard 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 (↑) switches between upper case and lower-case letters.
-When the lower-case keyboard is displayed, the ‘ABC’ key appears as ‘abc’.