CoaguSense Coag-Sense PT/INR User Manual
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CoaguSense Coag-Sense PT/INR User Manual

Prothrombin time /inr monitoring system
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Summary of Contents for CoaguSense Coag-Sense PT/INR

  • Page 2 CoaguSense. CoaguSense has made every reasonable effort to ensure that all the information contained in this manual is correct at the time of printing. However, CoaguSense reserves the right to make any changes necessary without notice as part of ongoing product development.

  • Page 3: Table Of Contents

    Table of Contents Table of Contents ..................3 Introduction....................1 System Description ..............3 Meter Specifications .............10 Performance Characteristics ..........11 Warnings and Precautions ...........12 Hazards and Symbols ............16 Directions for Use .................17 Meter Setup ................17 Performing a Control Test ............27 Collecting a Fingerstick Sample ...........32 Performing a PT Test ............34 Performing an Stat Test............41...

  • Page 5: Introduction

    Introduction ® The Coag-Sense Prothrombin Time (PT)/INR Monitoring System Intended Use 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. It uses fresh capillary whole blood. It is intended for use by health care professionals at the point of care to monitor patients who are on warfarin-type (coumarin) anticoagulation therapy.
  • Page 6 The purpose of the Coag-Sense Prothrombin Time (PT)/INR Monitoring System User Manual is to help you understand your Coag-Sense PT/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.

  • Page 7: Table Of Contents

    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 whole blood. Page 3...
  • 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 display button. There are three touch buttons, Cancel or Previous Screen Button, Home Screen Button and View Button Screen for the Guided User Interface (GUI) operation.
  • Page 9 seconds result (a true prothrombin time) is converted to an INR (International Normalized Ratio) using the calibration data communicated by the NFC tag and subsequently stored in the meter. INR is a mathematical correction of the PT result that adjusts for sensitivity differences among different PT/INR systems. 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.
  • Page 10 A stylus with a rubber capacitive tip may be used to facilitate typing. Power Supply and Battery: Coag-Sense PT/INR Professional System can be operated only with the power adapter provided. The power adapter also serves as a charger. It charges the in-built Lithium Polymer Battery.
  • Page 11 To perform a test, you require the following:  Coag-Sense Test Strip Kit- 50 (Catalog # 03P56-50) is supplied with the following items; Item Description Patient Test Strips Low Control Strips High Control Strips Control Strip Activation Solution Lot Info label w/NFC Tag (Bottom Right Corner of Box) Sample Transfer Tubes w/ plungers Package Insert ...
  • 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 message and the its 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 Icons on the touchscreen: a) Back Icon- Directs to the previous screen b) Home Icon- Directs to the home screen c) Settings Icon- Directs to the setting screen d) User Information Icon- Directs to the User Information screen e) Log-out Icon- Directs to the logout pop up screen.

  • Page 14: Meter Specifications

    Meter Specifications Operating Temperature 65°F to 90°F (18°C to 32°C) Operating Humidity 10% to 85% (without condensation) Storage Temperature 32°F to 122°F (0°C to 50°C) Storage Humidity 20% to 80% Memory Capable of storing up to,  2000 patient test results with date and time ...

  • Page 15: Performance Characteristics

    It is recommended that the same method be used to monitor the anticoagulation therapy over time. Measuring Range: INR 0.8 to 8.0 Normal Range: The following example represents a common normal range for the Coag-Sense PT/INR system. INR: 0.7 to 1.2 PT: 8.0 to 15.0 Page 11...

  • Page 16: Warnings And Precautions

    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 expiration date.
  • Page 17  Only use the method provided in this User Manual to clean the Coag-Sense PT/INR meter.  Do not move or touch the meter while it is running a test. Unreliable results may occur.
  • Page 18 “Test Cancelled, Remove Strip‟ The strip should be removed at this time only.  Store and use the Coag-Sense PT/INR system following the instructions in this manual.  This equipment is tested to meet the limits for medical devices,...
  • Page 19 The Coag-Sense Prothrombin Time (PT)/INR Monitoring System.”  “The use of accessories, transducers and cables other than those specified by CoaguSense, may result in increased EMISSIONS or decreased IMMUNITY of the EQUIPMENT.”  “The Coag-Sense Prothrombin Time (PT)/INR Monitoring System...

  • Page 20: Hazards And Symbols

    Hazards and Symbols Warning: This indicates a warning or precaution, requiring special attention. Class II Equipment. The Power Adapter is double insulated. Biological Risks: Disposable items pose biological risks. The strips and fingerstick materials should be disposed of in appropriate biohazard waste containers.

  • Page 21: Directions For Use

    Directions for Use 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. Operating conditions are between 65ºF and 95ºF (18ºC and 35ºC).
  • Page 22 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 function.
  • Page 23 Action Image guided instruction Software Version Update a) If there is a new software version available, it can be found in this screen (only if meter is connected to the Internet- Refer to Section 15). b) Clicking the new version will download the version.
  • Page 24 Action Image guided instruction Theme: User chooses from Mono/Blue/Color Language Setup Note: The default language is set to English. Date Format Setup Time Format Setup Date and Time Setup Note: The time automatically adjusts for daylight savings time. Page 20...
  • Page 25 Action Image guided instruction Time Zone Setup Brightness: User chooses from range of 1-7 Sound Setting: User chooses to Turn sound ON or OFF Target Range Setup Alarm: User can set alarm as a reminder function with Time and set to repeat on selected days of the week.
  • Page 26 Action Image guided instruction Communication Settings The screen lists the status of the communication channels. If connected to Wireless (Wi-Fi), the touchscreen displays the name of the Wi-Fi network. The forward button on each type will direct the User to a detailed view.
  • Page 27 Bluetooth broadcast icon This screen displays the list of scanned Bluetooth enabled devices. Broadcast Bluetooth will pair the Coag-Sense PT/INR meter to external device. Note: Set the external device ready to connect to the Coag-Sense meter. The touchscreen displays a message if the Bluetooth connection fails.
  • Page 28 Action Image guided instruction External Connection a) Screen lists server IP address for socket communication b) Open/Close port for serial communication with external program c) Connects PT/INR meter to PC program using Bypass Mode. Admin Settings QC Lock Settings: If a Control test (High Control or Low control) does not produce a result, or if the result is outside of...
  • Page 29 Action Image guided instruction User Management: User Management screen, a) displays the „Admin‟ account that was previously set up (Initial Setting Section). Admin User may choose to change the password by clicking this Edit Administrator Login field. b) displays the list of User accounts.
  • Page 30 (Admin User defined) frequency. In the QC Lock Settings menu, the Admin User can define the QC Testing time intervals. The time intervals options are; Daily, Weekly, Monthly and No cycle. Note: For waived testing performed under a CLIA Certificate of Waiver, quality control checks must be performed by following manufacturer‟s instructions.

  • Page 31: 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 32 Action Image guided instruction Press the Login icon. User is now directed to enter login credentials or scan operator barcode using a standard barcode scanner. Note: To configure your meter for Auto login please contact technical support. Successful login directs the user to the Home screen.
  • Page 33 Action Image guided instruction number) will auto populate. If box with NFC tag information is not available, you may manually enter the Lot # and Barcode # using the keypad on the touchscreen into the respective fields. Press the forward button. Note: Ensure the strip expiration date on the strip packaging has not passed.
  • Page 34 Action Image guided instruction 9 Insert the black plastic plunger into the end of the glass capillary tube with the red stripe. Use care to avoid hitting white plug. (Preloaded tubes are also available) Open the control activation solution and hold at an angle to allow insertion of the transfer tube.
  • Page 35 Action Image guided instruction When the control activation solution is properly applied and detected, the flashing green light will turn off, and the meter displays „Testing Please Wait‟. Note: If this screen is not displayed within 8 seconds not enough solution was applied.

  • Page 36: Collecting A Fingerstick Sample

    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  Sterile alcohol prep pads  Gauze square and Band-Aids ...
  • Page 37 The best test sample is when:  The blood is collected right after the fingerstick and put into the sample well without delay. If there is any delay in sample collection or application, repeat with a fresh fingerstick and a new strip.

  • Page 38: Performing A Pt Test

    Action Image guided instruction Remove the cap from the single use lancet. Place it against the skin. Holding the body of the lancet, push down firmly against the finger to lance the surface of the skin. Do not lance finger until meter displays “APPLY SAMPLE”.
  • Page 39 Successful login directs the user to the Home screen. Press the Test icon on display screen. Note: If the control test fails, patient test feature will be disabled, please contact CoaguSense technical support for assistance. Page 35...
  • Page 40 Action Image guided instruction 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 number) and Barcode # (eight-digit...
  • Page 41 Action Image guided instruction Holding the round end, gently push the strip completely into the meter. The strip fits snuggly when pushed all the way toward the back wall of the strip insertion area. The meter warms the strip (for 25 seconds) to operating temperature.
  • Page 42 Action Image guided instruction Note: Discard the sample transfer tube in a biohazard container. When the sample is detected, the meter displays a „Testing Please Wait‟ message. Note: If this screen is not displayed within 8 seconds not enough blood sample was applied.
  • Page 43 Action Image guided instruction User may also print the results as well, refer to the “Printing” section in this manual. Note: The meter stores about 2000 patient test results in memory with the time and date stamp. Refer to “Reviewing the Memory” in this manual for more information.
  • Page 44 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. Consider re-testing using an alternative method prior to adjusting the patient‟s dose of anticoagulant medication, or any...

  • Page 45: Performing An Stat Test

    11. Performing a Stat Test A Stat Test allows the user to perform and obtain results of a patient test without logging in a user account or entering a Patient ID. Stat test results are saved in the memory of the meter with Patient ID as Stat, along with patient result it also records the date and time the test was performed.
  • Page 46 Action Image guided instruction Barcode # using the keypad on the touchscreen into the respective fields. Press the forward button. Note: Make sure the expiration date on the strip packaging has not passed. Contact your Coag-Sense distributor for help with reordering. 3 Open the packaging of the test strip by tearing the notched end.
  • Page 47 Action Image guided instruction 7 IMMEDIATELY after collecting the patient sample, place the tip of the sample transfer tube at a 45º angle into the sample well on the test strip in front of the wheel where you see the flashing green light. Gently touch the tip down onto the sample well.
  • Page 48 Action Image guided instruction Remove the test strip and dispose in a biohazard collection container. Note: Repeat the test if the results seem unusually low or high. If the results still seem unusual after a second test, contact Technical Support. Page 44...

  • Page 49: Reviewing The Memory

    POCT1-A protocol. Memory is not lost if there is a break in power for any length of time. Test results stored in the Memory can only be erased by CoaguSense technical support. Follow the steps below to review results in memory:...
  • Page 50 Action Image guided instruction Successful login directs the user to the Home screen. Press the Results on display screen. 2 The „Results‟ screen lists Patient test results and Control test results. 3 User can select from the various results stored in memory to view details of that results.
  • Page 51 Action Image guided instruction 5 Clicking the chart icon displays the test result for the selected patient in a chart/list output. The unit of the x-axis value of the chart depends on the period selected. The User may choose to view up to one month.

  • Page 52: Printing

    13. Printing With the portable printer (optional accessory) available from Coag- Sense, results from the Coag-Sense meter memory can be printed on either thermal paper or other media such as thermal labels for applying to patient charts. Note: Contact your Coag-Sense distributor for help with ordering. Note: Refer to the User Manual provided with the printer for its general operation.
  • Page 53 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. The meter cannot print directly to your computer printer.

  • Page 54: Network Connectivity And Security

    14. Network Connectivity and Security The Coag-Sense meter offers the ability to send patient test results to electronic medical records or laboratory information systems. The Coag- Sense meter can be connected to a Local Area Network (LAN) via either a direct Ethernet connection or wirelessly using Wi-Fi. If this meter is connected to a local area network, the network must be protected against unauthorized access.

  • Page 55: Upgrading Meter Software

    15. Meter Software Update When connected to the Internet, the Coag- Sense meter can 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 56: Battery

    16. Battery The Coag- Sense meter has a factory installed Rechargeable Lithium Polymer Battery, that charges when the power adapter (provided with the meter) is plugged into the wall socket. A charged battery (6 hours to fully charge) can run approximately 200 tests. Please be aware that battery life may be affected by many factors such as operating conditions (e.g.

  • Page 57: Cleaning And Disinfecting The Meter

    17. Cleaning and Disinfecting the Meter No maintenance is required other than routine cleaning and/or disinfecting. When the power is off and the USB cable is not connected, the meter housing can be cleaned and disinfected. Wipe all exposed surfaces with Healthcare Bleach Germicidal Wipes containing Sodium Hypochlorite (EPA No.
  • Page 58 the connectors or plugs on the meter. If you suspect any physical damage or deterioration of the meter (such as cracking or gross distortion), or if the meter does not turn on after cleaning, call Technical Support. Always refer to local, state and federal disinfecting guidelines. More information on bloodborne pathogen safety and proper disinfecting techniques can be found at: “FDA Public Health Notification: Use of Fingerstick Devices on More...

  • Page 59: 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 866-903-0890 or email techsupport@coagusense.com. Meter Display Possible Cause(s)
  • Page 60 Meter Display Possible Cause(s) Solution one hand while inserting the strip completely with the other hand. Insert the strip using a quick smooth motion. Try again with another strip. If the message persists, contact Technical Support. LIQUID There may be a problem with Take the strip out and PROBLEM the strip or with the optical...
  • Page 61 Meter Display Possible Cause(s) Solution correctly. Verify the date setting on the meter is current. NO SAMPLE Either no sample or not Repeat the entire procedure DETECTED enough sample was applied (including fingerstick on a to the strip within 2 1/2 different finger) with a new minutes after the “Apply strip.
  • Page 62 Meter Display Possible Cause(s) Solution activation solution to the Depress black plunger white plug completely to dispense the control activation solution sample. Applying the control activation solution to the test strip before ¨Apply Control Repeat the entire procedure Solution¨ displayed on with a new strip.
  • Page 63 Meter Display Possible Cause(s) Solution CLOT TIME The clotting time was very Repeat the entire procedure TOO SHORT short and out of testing range (including fingerstick on a (<8 seconds). different finger) with a new strip. An air bubble was detected in the sample.
  • Page 64 Meter Display Possible Cause(s) Solution current test. The meter connected to the power adapter should be plugged into the wall socket. General Troubleshooting Issue Possible Causes Solution Meter does not Insufficient Battery to Power Check if the power adapter power ON (provided with the meter) is connected to the port in the Meter and the wall socket.
  • Page 65 Issue Possible Causes Solution not responding sunlight. direct sunlight, as it may reduce life expectancy and functionality of the display. Dropping or subjecting the Contact Technical Support meter to strong shocks. Touch screen Dropping or subjecting the Contact Technical Support scratched or meter to strong shocks cracked...
  • Page 66 Issue Possible Causes Solution test strip kit from the same kit lot, use the NFC tag from that box(es). NFC Tag Touch or bring the NFC tag Improper scanning of the Issues: NFC tag. to proximity of the NFC Tag ...

  • Page 67: Warranty

    Limited One (1) Year Warranty Use of the Coag-Sense PT/INR System The Coag-Sense PT/INR system is designed for use in monitoring patients on oral anticoagulant therapy. Proper adherence to the instructions in this User Manual and package insert are critical to proper operation.
  • Page 68 Instructions for Meter or Product Return Upon review and agreement with CoaguSense Technical Service, you may be directed to return the unit. Should this occur, clean the outside surface as described in the “Cleaning and Disinfecting the Meter” section. The original packaging may be required for this purpose.

  • Page 69: Reordering Information

    Reordering Information For a description of the products listed below, please see the information above. Product Catalog # Coag-Sense PT/INR Professional System 03P70-02 Coag-Sense Test Strip Kit, Box of 50 03P56-50 Coag-Sense Control Strip Kit -10 03P69-10 Sample Transfer Tubes with Plungers,...

  • Page 70: Index

    21. Index Admin Settings, 24 E-Mail Support, 69 Alarm, 21 Ethernet Port, 4 Alcohol Wipe, 32 Expected Values, 11 External Server Connection, Battery, 6, 52 Battery Low, 60 Blood Flow, 32 Fingerstick Sample, 32 Bluetooth Setting, 23 Brightness, 21 Hazards And Symbols, 16 Heater Problem, 56 Calibration, 5 High Control Strip, 27...
  • Page 71 Motor Problem, 56 Room Temp Incorrect, 55 Near Field Communication Sharps Container, 32 (NFC) Tag, 5 Sleep Settings, 24 Network Connectivity and Software Udate, 51 Security, 50 Software Version Update, 19 No Sample Detected, 57 Sound Setting, 21 Normal Range, 11 Squeezing the Fingerstick Site, 12 STAT Test, 41...
  • Page 72 Technical Support CoaguSense, Inc. 48377 Fremont Blvd., STE 113 Fremont, CA 94538 Toll Free: 1-866-903-0890 E-Mail: techsupport@coagusense.com CoaguSense, Inc. 48377 Fremont Blvd, STE 113 Fremont, CA 94538 USA Tel: (510) 270-5442 Fax: (510-226-6540 EMERGO EUROPE Prinsessegracht 20 2514 AP, The Hague...

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