CoaguSense Coag-Sense User Manual
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CoaguSense Coag-Sense User Manual

Prothrombin time (pt)/inr monitoring system
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PST
Patient Self-Testing
User Manual
Coag-Sense
®
Prothrombin Time (PT)/INR
Monitoring System

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Summary of Contents for CoaguSense Coag-Sense

  • Page 1 Patient Self-Testing User Manual Coag-Sense ® Prothrombin Time (PT)/INR Monitoring System...
  • Page 2 CoaguSense, Inc. CoaguSense, Inc. has made every reasonable effort to ensure that all the information contained in this manual is correct at the time of printing. However, CoaguSense, Inc. reserves the right to make any changes necessary without notice as part of ongoing product development.

  • Page 3: Table Of Contents

    Table of Contents Introduction ................1 System Description ..............3 Meter Specifications ..............11 Performance Characteristics ............. 13 Warnings and Precautions ............14 Hazards and Symbols ............... 18 Directions for Use ................20 Meter Setup ................20 Performing a Control Test ............28 Collecting a Fingerstick Sample ..........
  • Page 4 The Coag-Sense Prothrombin Time (PT)/INR ® Monitoring System for Patient Self-Testing is intended to be used by a single person and should not be shared.

  • Page 5: Introduction

    Coag-Sense Prothrombin Time (PT)/INR Monitoring System ® Intended Use For self-test users, the Coag-Sense Prothrombin Time (PT)/INR Monitoring ® System is an in vitro diagnostic device that provides quantitative prothrombin time (PT) results, expressed in seconds and International Normalized Ratio (INR) units.
  • Page 6 ® System User Manual is to help you understand your Coag-Sense ® INR System, its parts, and its intended function. It provides you with the information you need to perform a PT test with the Coag-Sense PT/INR ® System. The Coag-Sense System should only be used with a doctor’s...

  • Page 7: System Description

    2. System Description The Coag-Sense Prothrombin Time PT/INR System is used for quantitative ® measurement of INR (International Normalized Ratio) based on a Prothrombin Time (PT) response to monitor the effect of therapy with vitamin K antagonists like Coumadin (warfarin). The system uses fresh, capillary ®...
  • Page 8 Meter: The meter has a TFT color LCD Touch Screen that shows results, information, icons and results recalled from memory. To select an option, gently click on the display button. There are three touch buttons, Cancel or Previous Screen Button, Home Screen Button and View Menu Button Screen for the Guided User Interface (GUI) operation.
  • Page 9 Handle Control Strips and Control Activation Solution Quality control is an important part of PT testing to verify the integrity of the performance characteristics of the testing system. The Coag-Sense Meter ® has been designed with multiple internal systems to ensure proper system function.
  • Page 10 Power Supply and Battery: Coag-Sense PT/INR Patient Self-Test System can be operated only with ® the power adapter provided. The power adapter also serves as a charger. It charges the built-in Lithium Polymer Battery. The battery life is shown on top right corner of the meter.
  • Page 11 If you participate in a testing service, your service provider will provide you with all the necessary testing components. If you run out of testing supplies, please contact the service provider that gave you your meter for more supplies. If you purchased a Coag-Sense Test Strip Kit (Catalog# 03P56- ®...
  • Page 12 Overview of Buttons and Icons The buttons and icons that appear during normal operation are shown here, along with their respective meanings. Error messages and their description are provided in ”Troubleshooting” section. Buttons/Icons Meaning Power ON/OFF To power ON the meter, press and hold Power Button.
  • Page 13 Buttons/Icons Meaning The Status Bar 1. Current Date/Time 2. Sound On/Off status 3. Alarm – The presence or absence of set alarm 4. Bluetooth On/Off status 5. Wi-Fi On/Off Status 6. Battery status Icons on the Touchscreen The Icons on the Touch Screen 7.
  • Page 14 Buttons/Icons Meaning Home Screen 1. Test Icon - Go forward to test screen when touched. 2. Control Icon - Go forward to control test screen when touched. 3. Results Icon - Go forward to result screen when touched. 4. Settings Icon - Go forward to setup screen when touched.

  • Page 15: Meter Specifications

    Rechargeable Lithium Polymer Battery Lithium Battery (3.7V, 2350mAh) Fully charged battery (6 hours of charging) Battery Capacity can run ~100 tests 120V AC Adapter (Use with Coag-Sense ® Power Input Adapter Only) 100-240V~, 50-60Hz, 0.5A AC Input (Mains supply voltage fluctuation: ±10%) Power Output 5.0V, 2.0A...
  • Page 16 315 grams Class II with external power supply. Equipment Classification Internally powered when operated with battery. IPX0 rating. WARNING: Use the Coag-Sense Meter along ® with the provided Power Adapter only. Use only AC adapter type UES12lCP-050200SPA (Manufacturer: Dongguan Shilong Fuhua Electronics).

  • Page 17: Performance Characteristics

    Measuring Range: INR 0.8 to 8.0 units Normal Range: The following results represent a common normal range for an individual in good health using the Coag-Sense PT/INR Monitoring ® System.

  • Page 18: Warnings And Precautions

    • The system should also not be used to monitor patients on direct oral anticoagulants (DOACs) including Factor Xa and Direct Thrombin inhibitors. Test Site and Blood Sample • The Coag-Sense PT/INR System is for in vitro diagnostic use only. ® • The Coag-Sense Meter will not produce a result if the test strip is past its ®...
  • Page 19 Meter • The meter has a built-in rechargeable lithium polymer battery (3.7 V, 2350 mAh). • Use only the power adapter included with the Coag-Sense System or ® damage to the meter may result.
  • Page 20 • Any equipment connected to the data port must be certified to IEC 60601-1. If you connect any equipment that is not recommended by CoaguSense, Inc., you are responsible for meeting the requirements of this standard. • In the unlikely event of an electric power surge (i.e., severe static discharge during a thunderstorm), when using the power adapter, the display screen may go blank.
  • Page 21 Prothrombin Time PT/INR Monitoring System. ® • The use of accessories, transducers and cables other than those specified by CoaguSense, Inc. may result in increased EMISSIONS or decreased IMMUNITY of the EQUIPMENT. • The Coag-Sense Prothrombin Time PT/INR Monitoring System should ®...

  • Page 22: Hazards And Symbols

    6. Hazards and Symbols Caution is necessary when operating the device Class II Equipment Biological risks: The strips and fingerstick materials should be disposed of in appropriate biohazard waste containers Indicates the date after which the medical device is not to be used Indicates the manufacturer’s batch code so that the batch or lot can be identified...
  • Page 23 Indicates the entity importing the medical device into the locale The system fulfills the U.S. safety requirements (NEMKO listed) Consult instructions for use Near Field Communication (NFC) Tag Indicates the manufacturer’s serial number so that specific medical device can be identified Indicates a carrier that contains unique identifier information Bluetooth Connectivity, BLE Enabled Devices...

  • Page 24: Directions For Use

    Directions for Use 7. Meter Setup Operating Conditions To ensure that your Coag-Sense PT/INR System is working correctly, be ® sure the following conditions are met: • Be sure that the meter and strips are at room temperature before use.
  • Page 25 System and User Settings: The meter is set to default factory settings, English is the default language and time/time zone is Pacific Standard time (UTC-8:00). User may modify User settings as appropriate. Refer to User Settings section in this manual for the list of settings and their functions.
  • Page 26 Action Instructions 2. Software Version Update 1. See Device Information screen for version of software. 2. If there is a new software version: The latest version can be found in this screen. Clicking the ‘New version’ will download the software update. 3.
  • Page 27 Action Instructions Device Setup 1. Device Settings Screen 2. Date/Time Settings Page 23...
  • Page 28 Action Instructions Communication Settings 1. Status The screen lists the status of the communication channels. The forward button on each type will direct the User to a detailed view. 1. Communication settings. 2. If connected to the Wireless, touchscreen displays the name of the Wi-Fi network. 3.
  • Page 29 Action Instructions 3. Upon clicking the ‘Setup’ icon 12. The touchscreen displays the Wireless Information screen. 13. Select a connection method. 14. Input into the fields for the wireless network information, i.e., IP address, Mask, Router and DNS server. 15. Click ‘Confirm’ to proceed and enter the security password for connecting to a network.
  • Page 30 DHCP server is plugged in. 6. Bluetooth Bluetooth Select Menu. Connect mobile device. 23-1. Set the external device ready to connect to the Coag-Sense Meter. ® 23-2. Bluetooth broadcast success pop-up. 23-3. Bluetooth Broadcast Fail pop-up. Troubleshoot when mobile device has a bluetooth pairing problem.
  • Page 31 Instructions 7. Reset Bluetooth Paired Devices 24-1. Reset and connect cell. Reset Bluetooth paired devices pop-up Broadcast Bluetooth will pair the Coag-Sense ® PT/INR Meter to an external device. Set the external device ready to connect to the PT/INR meter.

  • Page 32: Performing A Control Test

    8. Performing a Control Test There are 2 low control strips, 2 high control strips and a control strip activation solution shipped with each test strip kit. Controls should be tested immediately upon receipt of each new lot number. Extra controls may be ordered separately if more frequent QC testing is required.
  • Page 33 Follow these steps to perform a test on a Low or High Control. Action Instructions 1. Power the meter ON by pressing and holding the (POWER) button on the right side of the meter. Note: The message field on the first screen will display any errors encountered during self-check.
  • Page 34 Action Instructions 2. Home screen will be displayed. 1. Test. Go forward to Test screen when touched. 2. Control Test. Go forward to Control test screen when touched. 3. Results. Go to forward to Results screen when touched. 4. Settings. Go forward to Settings screen when touched.
  • Page 35 Lot # and Barcode # manually using the keypad on the touchscreen. Press the “Forward arrow.” Note: Ensure the strip expiration date on the strip packaging has not passed. Contact your Coag-Sense System distributor for help ® with reordering. 5. Open the packaging of the selected Control Strip by tearing the notched end.
  • Page 36 Action Instructions 6. Holding the round end, gently push the strip completely into the meter. The strip fits snugly when pushed all the way toward the back wall of the strip insertion area. 7. The meter warms the strip (for 25 seconds) to operating temperature, the display shows a countdown in seconds.
  • Page 37 POWER button. The opened control activation solution may be used until the expiration date. Note: If control test fails, repeat the test with a new strip. If the control test continues to FAIL, contact Coag-Sense Technical Support for assistance. ®...

  • Page 38: Collecting A Fingerstick Sample

    9. Collecting a Fingerstick Sample Tips for a Successful Fingerstick • Make sure that you have all the supplies needed before you start. • 21g Lancet device (Single use, auto disabling) • Sample Transfer Tubes • For fingerstick blood testing, increasing the flow of blood in the finger will help you capture a good drop of blood.
  • Page 39 WARNING: Blood samples, controls, used test strips, transfer tubes and lancets are potentially infectious. Dispose of strips and collection devices using universal precautions. Image Guided Action Instruction 1. Wash your hands with soap and warm water. Dry completely. If cleaning with an alcohol wipe, the finger must be wiped dry with sterile gauze (air drying is insufficient to remove residual alcohol in time).
  • Page 40 WARNING: Squeezing the fingerstick site excessively (milking) releases interstitial “tissue layer” fluid that causes unreliable results. Action Instructions 4. When ready to collect the drop of blood, hold the Sample Transfer Tube horizontally. Touch tip to bead of blood and let capillary action fill until blood flow stops at the green band.

  • Page 41: Performing A Pt Test

    10. Performing a PT Test WARNING: Place the meter on a stationary, level surface for testing. DO NOT move the meter or allow it to vibrate during the test. Unreliable results may occur. Follow the below steps to perform a patient test: Action Instructions 1.
  • Page 42 Action Instructions 3. Patient Strip Lot confirmation screen displays the Lot information of the strip that was last recorded. Proceed with testing if the test strip is from the same lot. Otherwise, scan the NFC Tag against the NFC Tag scanner on the meter, the Lot # (six-digit numeric identifier) and Barcode # (eight-digit numeric identifier) will auto populate.
  • Page 43 Action Instructions 6. The meter warms the strip (for 25 seconds) to operating temperature. The display shows a countdown in seconds. Note: Do not apply test sample until the warm-up is complete and the meter display shows ‘Apply sample.’ While the meter is warming up, get ready to perform a fingerstick See “Collecting a Fingerstick Sample”...
  • Page 44 Action Instructions 9. When testing is complete, the meter beeps (if sound is turned ON). The results (INR and PT seconds) are displayed on the screen along with the date and time of the test. Note: Memo field allows you to make notes such as medication or diet change along with the results.
  • Page 45 What to do when you get an unexpected result: Follow instructions for re-testing on the Coag-Sense PT/INR ® Meter. For unexpected results, contact Technical Support at 1-866-903-0890.

  • Page 46: Reviewing The Memory

    11. Reviewing the Memory The Coag-Sense Meter stores up to 2000 patient test results and 500 control ® test results, along with the respective date and time of the test performed. When the memory has reached maximum storage capacity, the oldest result is automatically deleted and gets replaced with the most recent result.
  • Page 47 Action Instructions 3. The ‘Results’ screen lists Patient test results and Control test results. 4. User can select an individual result from the list of results stored in memory to view its details or select the graph icon in the lower right corner to plot the results over a time period.

  • Page 48: Printing

    12. Printing With the portable printer (optional accessory) available from CoaguSense, Inc. results from the Coag-Sense Meter memory can be printed on thermal ® paper. What you’ll need: • Coag-Sense Meter ® • Optional Portable Printer, Catalog # 03P76-01 • 2” Thermal Paper, Catalog # PD99906 Follow the steps below for printing results.
  • Page 49 If the results fail to print, confirm that the printer is ON and charged as it automatically turns OFF after a few minutes. Note that the meter can only print to specific printers qualified and supplied by CoaguSense, Inc. The meter cannot print directly to your home computer printer.

  • Page 50: Network Connectivity And Security

    13. Network Connectivity and Security The Coag-Sense Meter offers the ability to receive product software ® updates from the manufacturer via the Internet. The Coag-Sense Meter can ® be connected to a Local Area Network (LAN) via either a direct Ethernet connection or wirelessly using Wi-Fi.

  • Page 51: Meter Software Update

    15. Meter Software Update When connected to the Internet the Coag-Sense ® Meter will check for the availability of meter software updates which can be downloaded. If the meter is not continuously connected to the Internet, you should make it a practice to periodically connect the meter to the Internet to check for software updates.

  • Page 52: Battery

    Only charge battery using the power adapter provided along with the Coag-Sense® Meter. Use of other power cables may result in damage to the meter.

  • Page 53: Cleaning And Disinfecting The Meter

    Do not clean/disinfect inside the meter where the test strip is inserted. Cleaning this area should be avoided. Please contact Technical Support at techsupport@coag-sense.com or call 1-866-903-0890 if this area requires cleaning/disinfecting. WARNING: Do not put the meter in liquid. Do not allow liquids to get inside the meter or into any of the connectors or plugs on the meter.
  • Page 54 Always refer to local, state and federal disinfecting guidelines. More information on bloodborne pathogen safety and proper disinfecting techniques can be found at: Federal Register: Guidance for Industry and Food and Drug Administration Staff; Blood Lancet Labeling; Availability (https://www.federalregister.gov/documents/2010/11/29/2010-29795/ guidance-for-industry-and-food-and-drug-administration-staff-blood-lancet- labeling-availability#:~:text=On%20August%2026%2C%202010%2C%20 the%20FDA%20and%20Centers,patient%20poses%20a%20risk%20of%20 transmitting%20bloodborne%20pathogens.)

  • Page 55: Troubleshooting

    This section details how to resolve most problems that you might encounter. If you have any questions or problems during the troubleshooting process, note the display wording and contact Technical Support at 1-866- 903-0890 or email techsupport@coag-sense.com. Meter Display Possible Cause(s)
  • Page 56 Meter Display Possible Cause(s) Solution LIQUID There may be a problem with the Take the strip out and reinsert PROBLEM strip or with the optical system of holding the back of the instrument the meter. steady with one hand while inserting the strip completely with the other hand.
  • Page 57 Meter Display Possible Cause(s) Solution TEST STRIP The lot of strips have expired. Use a different lot of strips that has EXPIRED not expired. SEE MANUAL Meter date is not set correctly. Verify the date setting on the meter is current. NO SAMPLE Either no sample or not enough Repeat the entire procedure...
  • Page 58 Meter Display Possible Cause(s) Solution CONTROL There was no clot formation; Repeat the entire procedure with FAIL-NO CLOT sample clotting time was very long a new strip. If the same message DETECTED and out of testing range. persists and if you have additional inventory of the test strip kit from the same kit lot, use the control There was insufficient control...
  • Page 59 Meter Display Possible Cause(s) Solution CONTROL The control strip result is outside Repeat test with another control FAIL-OUT OF of its acceptable range (FAIL-out strip. If the second test is out of RANGE of range). This may be due to a range, contact Technical Support.
  • Page 60 General Troubleshooting Meter Display Possible Cause(s) Solution Meter does not Insufficient Battery to Power ON. Check if the power adapter power ON (provided with the meter) is connected to the port in the Meter Power Adapter is not connected and the wall socket. properly for charging the battery.
  • Page 61 Meter Display Possible Cause(s) Solution Touch screen Dropping or subjecting the meter Contact Technical Support. scratched or to strong shocks. cracked Using pointed or sharp- edged objects other than the recommended ‘finger’ or rubber stylus to touch the screen elements. Power Adapter Faulty Adapter (Bent power cord.
  • Page 62 Meter Display Possible Cause(s) Solution NFC Tag Issues: Improper scanning of the NFC Touch or bring the NFC Tag in Tag. proximity to the NFC Tag scanner. NFC Tag not If the issue persists, enter the working strip information manually into the Scanned Faulty NFC Tag scanner in the touchscreen to perform the...

  • Page 63: Warranty

    OF ONE (1) YEAR FROM DATE OF DELIVERY. WHEN THE METER IS USED FOR THE INTENDED PURPOSE AND IN THE APPROPRIATE MANNER, AND AFTER AN ATTEMPT IS MADE BY YOU AND COAGUSENSE, INC. TO FIX THE ISSUE BY TELEPHONE, COAGUSENSE, INC’S REMEDY IS TO REPAIR OR REPLACE THE METER AT THEIR DISCRETION.
  • Page 64 Instructions for Meter’s Return If there is an issue with the Meter, you agree to a telephone consultation with CoaguSense, Inc. Technical Service to attempt to remedy the issue. Upon review and agreement, you may be directed to return the PT/INR Meter to CoaguSense, Inc.

  • Page 65: Reordering Information

    20. Reordering Information For a description of the products listed below, please see the information above. Product Catalog # Coag-Sense PT/INR Patient Self-Test System 03P70-01 ® Coag-Sense Test Strip Kit - 50 count, Controls included 03P56-50 ® Coag-Sense Test Strip Kit 6-count 03P70-06 ®...

  • Page 66: Emc Tables

    21. EMC Tables The following tables contain the Manufacturer’s declaration and additional information required by IEC 60601-2:2014 (Fourth Edition). Ref. Ports to AC Mains Test Level Test Name Notes Standard Test Voltage Required Mains 100V-50Hz CISPR Terminal 100V-60Hz Group I, 11:2015±...
  • Page 67 Ref. Ports to AC Mains Test Level Test Name Notes Standard Test Voltage Required ±0.5kV, 5 pulses at EC 61000- ±1kV 0° 90° Surges 4-5:2014/ AC Mains 230V-50Hz L1 to L2 180° AMD:2017 (DM) 270° 3Vrms 150kHz to 80MHz Conducted 6Vrms in Disturbances, EC 61000-...

  • Page 68: Index

    22. Index Alarm 9 Email Support 2, 66 Alcohol wipes 7,15, 35 EMC Tables 61 Ethernet Port 4 Expected Values 13 Battery 6, 9, 11, 47, 48, 51, 56 External Server Connection 27 Battery Low 53 Blood Flow 34, 36, 55 Fingerstick Sample 14, 15, 34 Bluetooth 24, 26, 27 Bluetooth Settings 9, 19, 34, 36, 55...
  • Page 69 Measuring Range 13 Software Update 48 Memory 11, 40, 42, 43, 44 Software Version Update 22 Meter Specifications 11 Sound Settings 24 Squeezing the Fingerstick Site 14, 36 Motor Problem 52 System Description 3 System Settings 21 Near Field Communication (NFC) Tag 4, 5, 6, 7, 19, 31, 38, 57, 58 Network Connectivity 46 Technical Support 2, 66...
  • Page 70 Technical Support CoaguSense, Inc. 48377 Fremont Blvd., Suite 113 Fremont, CA 94538 U.S.A. Techincal Support: 1-866-903-0890 Email: techsupport@coag-sense.com www.coag-sense.com Manufactured By: CoaguSense, Inc. 48377 Fremont Blvd., Ste 113 Fremont, CA 94538 U.S.A. Made in Korea In vitro diagnostic medical device...
  • Page 71 Authorized Representatives Australian Sponsor Qatar Emergo Australia Sedeer Medical Services Level 20 Tower II Address: Bldg No 155 ,Door #1, Darling Park 1st Floor, Gate #1, 201 Sussex Street Ahmed Bin Ali St. Sydney, NSW 2000 St no 232, Area 37,Town Center Australia Bin Omran PO Box: 6782, Doha-Qatar...
  • Page 72 Patent 7,235,213 CSI P/N 200219 Rev AE Edition: July 2023 Page 68...

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