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Related Manuals for VivaChek BioSieve ToxiSmart FIA Reader
Summary of Contents for VivaChek BioSieve ToxiSmart FIA Reader
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- Page 2 ToxiSmart FIA Reader Dear BioSieve™ ToxiSmart FIA Reader User, Thank you for choosing the BioSieve™ ToxiSmart FIA Reader! The Reader has the advantages of easy operation, robust, reliable results, and simple maintenance. It can be used in a laboratory or in a point of care setting. This User Manual applies to BioSieve™...
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Page 3: Table Of Contents
TABLE OF CONTENTS 1. Understanding Your Reader..........1 Introduction....……………………......1 Components List……….……………………......1 Structure……………..……………………..…....1 Reader Display……………..……………..…....2 SBOM Information……………....……..…....2 Reader Use and Precautions……………..…....3 Important Safety Information……………………………….. Electromagnetic Compatibility………………………………. Precautions for Instrument Cybersecurity…………………. 5 2. Installation and Use Conditions........8 Installation.....……..……………………..….. -
Page 4: Understanding Your Reader
Note: If some parts are missing or damaged, please contact your Local Distributor or VivaChek Diagnostics Inc. USA immediately. The contact information for VivaChek Diagnostics Inc. USA is shown on the last page in this User Manual. Components List... -
Page 5: Reader Display
Reader Display Icon What it means Standard test mode Quick test mode System Quality Control mode Memory Bluetooth Battery level Printer Illegal devices attempting to connect A List for Interface That Is Expected to Receive and/or Send Testing Results: Interface Functionality Incoming, Outgoing, or Both Destination End-point... -
Page 6: Reader Use And Precautions
Important Safety Information • It is for in vitro diagnostic use by professionals only. • Use the accessories provided by VivaChek with your BioSieve™ ToxiSmart FIA Reader. Do not use other accessories. • Please read this User’s Manual carefully before use and keep your User Manual in a safe place for referring it in the future. -
Page 7: Electromagnetic Compatibility
Electromagnetic Compatibility Caution • Use of accessories, transducers and cables other than those specified or provided by the manufacturer could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation. Warning • Medical electrical equipment requires special precautions regarding EMC and must be installed and operated according to these instructions. -
Page 8: Precautions For Instrument Cybersecurity
IEC/EN 61000-3-3 Pass Voltage fluctuation / flicker emission Applicable EMC Standards • IEC 60601-1-2:2014+A1:2020 • EN 60601-1-2:2015+A1:2021 • IEC TS 60601-4-2:2024 RF Exposure Compliance This equipment complies with FCC radiation exposure limits set forth for an uncontrolled environment. End user must follow the specific operating instructions for satisfying RF exposure compliance. - Page 9 Bluetooth for wireless communication. The Bluetooth module on the Reader is only used for connecting to a printer. The Bluetooth connected printer is only used for printing the test results. The primary display of test results is with the Reader. Use of a printer is optional by the user. The Reader does not rely on networking or network connections to perform its intended use.
- Page 10 control or cybersecurity vulnerability by calling toll-free telephone or sending us email listed in the user manual or outer box.
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Page 11: Installation And Use Conditions
CHAPTER 2: INSTALLATION AND USE CONDITIONS Installation Please use the Reader under the proper conditions. Step 1: Place the Reader on a stable and level surface. The unit is portable and can be moved to a suitable location for testing. Avoid direct sunlight. Step 2: Press the right button “▶”... -
Page 12: Setting Up Your Reader
CHAPTER 3: SETTING UP YOUR READER Before using the Reader for the first time, you should check and update your Reader settings. System Log Press the right button “▶” for 5 seconds to turn on the Reader. Press the left button “◀”... - Page 13 (Figure 5) Set the Time and Date Press the left button “◀” to enter into the interface (Figure 6). Press the right button “▶” to select 24-hour time or 12-hour time format. (Figure 6) Press the left button “◀” to enter into the 24-hour time format (Figure 7). (Figure 7) Press the left button “◀”...
- Page 14 Note: Press the left button “ ” for 3 seconds to return to the previous ◀ interface. Bluetooth Pinter Connection Press the right button “▶” to select "Bluetooth", and press the left button “◀” to turn on the Bluetooth (Figure 9). (Figure 9) Press the right button “▶”...
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Page 15: About
successfully connected to the printer, last four digits of the connected printer model are displayed on the interface. If the Reader’s Bluetooth and printer are turned on, the interface will show the icons “ ” and “ ” (Figure 12). When the test is finished, press the right button “▶”... -
Page 16: Operation Instructions
CHAPTER 4: OPERATION INSTRUCTIONS Set up your Reader correctly and have all the materials you will need ready before you begin testing. It includes your BioSieve™ ToxiSmart FIA Reader and BioSieve™ FIA Test Kit. Start Press the right button “▶” for 3 seconds to turn on the Reader (Figure 14). (Figure 14) Choose Test Mode Standard Test Mode... -
Page 17: Standard Test
(Figure 16) In the quick test mode, you need to insert the test device after the reaction time is completed, and the Reader will display the test result in a few seconds. System Quality Control Mode Press the left button “◀” twice to change the test mode to system quality control test. -
Page 18: Quick Test
(Figure 19) Quick Test Step 1: Take the test device out of the foil pouch and place it on a clean, dust-free and flat surface. Step 2: Refer to the package insert to add the sample and wait for the pre-determined incubation time. -
Page 19: Viewing Your Test Results
Reader works normally, the interface will display “Pass”. Otherwise, it will display “Fail”. (Figures 22, 23) Viewing Your Test Results Press the left button “◀” for 3 seconds to enter into the "Menu". Test Record Press the left button “◀” to enter into the interface of "Test Record" (Figure 24). -
Page 20: Turning Off The Reader
first. Turning Off the Reader Press the right button “▶” for 3 seconds to turn off the Reader. -
Page 21: Maintenance And Precautions
CHAPTER 5: MAINTENANCE AND PRECAUTIONS Maintenance The Reader includes a rechargeable 3.7 Volt Lithium Ion battery. The battery will automatically charge while plugged into AC power. The Reader will automatically switch to battery power when battery is not recharged. Charging Instructions Indications on the Reader displayed for when the Reader is properly connected, actively charging, and adequately recharged: When the Reader is properly connected and actively charging, the Reader... - Page 22 BioSieve™ ToxiSmart FIA Reader can only be repaired, replaced or upgraded by the manufacturer. Please contact your local distributor or Vivachek Diagnostics Inc, USA for technical support. (3) To avoid the possible electrical shock, please turn off and unplug the cable prior to cleaning.
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Page 23: Precautions For Reader Use
Maintenance Plan The Reader should be cleaned and disinfected a minimum of once per week. Precautions for Reader Use 1. Please use the Reader in accordance with the User’s Manual provided by the manufacturer. 2. Reader data preservation and recovery procedures: The Reader can save the user test records. -
Page 24: Technical Information
CHAPTER 6: TECHNICAL INFORMATION System Specifications Feature Specification Principle Fluorescence Immunochromatography 4.90 inches (124.5 mm) x 2.85 inches (72.5 Dimensions mm) x 1.57 inches (40 mm) Weight 0.36 Ibs (165 g) Display size 1.54 inches LCD Power source Rechargeable 3.7 Volt Lithium Ion battery ⎓... -
Page 25: Limitations
Limitations • Please use the Reader carefully according to the User’s Manual provided by manufacturer. • Do not insert anything else into the slot except the test device. • The tested urine samples are potentially contagious. Please take protective measures such as wear protective gloves to avoid skin contact with the urine sample. -
Page 26: Index Of Symbols
Index of Symbols These symbols may appear on the packaging and in the instructions for the BioSieve™ POCT system. Symbols Explanation Consult instructions for use or consult electronic instructions for use Manufacturer Temperature limit Humidity limitation Batch code Catalogue number Model number Serial Number Caution, consult accompanying documents... -
Page 27: Warranty
Warranty Please complete the warranty card that came with the product and mail it to your distributor to register your purchase. If the Reader fails to work for any reason other than obvious abuse within the first three (3) years from purchase, we will repair or replace it with a new one free of charge. - Page 28 Warranty Card Please complete this warranty card to validate your warranty. Mail it within 30 days of purchase to your local distributor. If the Reader does not work for any reason other than obvious abuse in the first 3 years after purchase, we will repair or replace it with a new or equivalent Reader free of charge.
- Page 29 Level 2, Block 2, 146 East Chaofeng Rd.. Yuhang Economy Development Zone, Hangzhou, 311100, Zhejiang P.R. China Email: info@vivachek.com www.vivachek.com VivaChek Diagnostics Inc. USA Technical Support Toll Free No.: (888) 860-3894 Our service time is Monday-Friday, 8:00AM-5:00PM, Eastern Standard Time.
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