Summary of Contents for Microgem Sal6830
- Page 1 User Guide MicroGEM Sal6830 Point of Care PCR System For Use with MicroGEM Sal6830 SARS-CoV-2 Saliva Test For Use under an Emergency Use Authorization Only M0248 Rev4.3...
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Page 2: Table Of Contents
WARNINGS AND SAFE USE 1 INTRODUCTION 2 MicroGEM Sal6830 Point of Care PCR System AT A GLANCE 3 GETTING STARTED - SETUP 4 SETTINGS MENU 5 RUNNING A TEST 6 EXPORT RESULTS 7 SOFTWARE UPDATES 8 ERRORS AND WARNINGS 9 SYMBOLS... -
Page 3: Warnings And Safe Use
The power supply and adaptor are not serviceable. Caution: The power supply and adaptor that are provided should only be used with the MicroGEM Sal 6830 Point of Care PCR System. - Page 4 WARNINGS AND SAFE USE (Continued) Caution: Do not disassemble or attempt to repair the MicroGEM Sal 6830 Point of Care PCR System as there is a risk of damage to the system. This system does not contain serviceable parts and should be returned for repair.
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Page 5: Introduction
1 INTRODUCTION 1.1 Intended Use The MicroGEM Sal6830 Point of Care PCR System is a fluorescence-based detection system for the automated processing and analysis for use with the MicroGEM Sal6830 SARS-CoV-2 Saliva Test. This document describes the setup, configuration, and operation of the MicroGEM Sal6830 Point of Care PCR System. - Page 6 1 INTRODUCTION (Continued) 1.3 System Specifications 1.3.1 System Color Touch Screen 3.4 x 6” (86 x 154 mm) Communications 1x USB port for data export Data Storage 10,000 test results – 64GB Export via USB Power Requirements 24V – 180W Dimensions 15.8”...
- Page 7 9.2 Amps 1.4 Unpacking Unpack the MicroGEM Sal6830 Point of Care PCR System, taking care when lifting the system. There are carrying features at the front and rear of the system for assistance. Place on a clean, flat, level, and stable surface within reach of an electrical outlet. Place System in a location where the air vents located in the back of the instrument will not be blocked, at least 3.94”...
- Page 8 1 INTRODUCTION (Continued) 1.6 Maintenance & Cleaning The MicroGEM Sal6830 Point of Care PCR System is maintenance-free and has no user serviceable parts. In case of system failure or damage, contact MicroGEM technical support at techsupportedx@microgembio.com. MicroGEM recommends that the exterior system surfaces and the surfaces visible behind the door be cleaned after use.
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Page 9: Microgem Sal6830 Point Of Care Pcr System At A Glance
2 MicroGEM Sal6830 Point of Care PCR System AT A GLANCE MicroGEM Sal6830 Point of Care PCR System, Front View Door Barcode Scanner Touch Screen Connection Latch Test Cartridge Slot Front Lifting Feature Airflow Ventilation Feet... - Page 10 2 MicroGEM Sal6830 Point of Care PCR System AT A GLANCE (Continued) MicroGEM Sal6830 Point of Care PCR System, Rear View Airflow Ventilation Power Button Rear Lifting Feature Power Supply Connection...
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Page 11: Getting Started - Setup
3 GETTING STARTED – SETUP 3.1 Initial Setup Connect the 24V power supply to the system. Plug the adaptor into an appropriate electrical outlet (1). Power Up: Once the power is connected, press the Power Button on the right side of the system to power up and start the system (2). - Page 12 3 GETTING STARTED – SETUP (Continued) 3.2 User Interface Touch Screen Operation control of the MicroGEM Sal6830 Point of Care PCR System is performed using the system Touch Screen (5). 3.3 Home Screen Home Screen (6) displays buttons for access to: •...
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Page 13: Settings Menu
4 SETTINGS MENU Settings Home > Settings The Settings screen allows users to configure the instrument (7). Settings are saved even when power is off. Settings include: • Display Brightness • Volume Control • Version & Licensing • Admin Functions •... - Page 14 4 SETTINGS MENU (Continued) Advanced Settings Home > Settings > Advanced Settings The Advanced Settings page allows the user to adjust Time and Date (9). Settings are saved even when power is off. Settings include: 30 Aug 2021 • Time •...
- Page 15 4 SETTINGS MENU (Continued) Adjust Date Press the Date box on the Advanced Settings page to bring up the System Calendar (11). Touch the screen to change the date and move between months. Press off the Calendar to return to the Advanced Settings page.
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Page 16: Running A Test
5 RUNNING A TEST From the Home Screen, select the “Start New Test” button and follow the prompts (13). It is essential that the on-screen prompts are followed throughout the testing process. See specific test product inserts for further information. -
Page 17: Export Results
6 EXPORT RESULTS 6.1 Export Results via USB download. Test results can be downloaded from the MicroGEM Sal6830 Point of Care PCR System via a USB Flash Memory Drive. Download Sequence STEP 1 From the Home Screen, select Settings>Admin Functions to load the Admin Functions screen. - Page 18 6 EXPORT RESULTS (Continued) 6.2 Export via QR Code Individual test results can be downloaded from the MicroGEM Sal6830 Point of Care PCR System by scanning the QR code on the VIEW RESULTS PAGE (15) after the test is complete.
- Page 19 6 EXPORT RESULTS 6.3 Export Service Logs via USB Download Service logs for technical support troubleshooting can be downloaded from the MicroGEM Sal 6830 Point of Care PCR System via a USB Flash Memory Drive. Download Sequence STEP 1 From the Home Screen, select Settings>Admin Functions to load the Admin Functions screen.
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Page 20: Software Updates
USB Software Update Caution: Stored test data may be deleted during the software update process. Test results stored on the MicroGEM Sal6830 Point of Care PCR System must be exported prior to performing a software update. Caution: DO NOT REMOVE USB DRIVE DURING SOFTWARE UPDATE. -
Page 21: Errors And Warnings
This section provides troubleshooting steps for specific error and warning codes. Once the steps listed below are executed, if the error or warning persists, contact MicroGEM Technical Support. Contact information can be found at the end of the User Guide. - Page 22 8 ERRORS AND WARNINGS (Continued) Test Interrupted Error Error Name: Test Interrupted Description: The test failed because the door was opened during the test. Action: Repeat the test with a new kit and saliva sample. Cannot Save Settings Error Error Name: Cannot Save Settings Description: The settings you changed cannot be saved.
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Page 23: Symbols
A complete list of relevant symbols may be found at www.microgembio.com/covid-19/resources. 10 ORDERING AND CONTACT INFORMATION Reorder Numbers MicroGEM Sal 6830 Point of Care PCR System SCFMA Technical Support and Contact Information Technical support is available by visiting our website at www.microgembio.com/covid-19... -
Page 24: Warranty
11 WARRANTY 1 Year Limited Warranty The MicroGEM Sal 6830 Point of Care PCR System is a fluorescence-based system for the processing and analysis of MicroGEM Sal 6830 SARS-CoV-2 Saliva Tests. Proper adherence to the instructions in the User Guide is critical to proper operation. - Page 25 (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. © 2021 MicroGEM™ All rights reserved. All trademarks referenced are trademarks of MicroGEM group of companies. Pat: www.microgembio.com/patent M0248-Rev4.3...
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