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Table of Contents 1. Introduction ...........................................................................1 2. System Description .................................................................3 3. Meter Specifications .............................................................10 4. Performance Characteristics ................................................11 5. Warnings and Precautions ...................................................12 6. Hazards and Symbols ..........................
1. Introduction The 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 INR units. It uses fresh capillary whole blood.
Anticoagulation Medication: Oral anticoagulation medications, are typically prescribed to patients to avoid unwanted clots. The patient’s blood clotting time must be monitored to ensure that their dosage is correct.
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 whole blood.
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. The Power ON/OFF button is located on the right side of the meter.
INR is a mathematical correction of the PT result that adjusts for sensitivity differences among different PT 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. The Coag-Sense Meter has been designed with multiple internal systems to ensure proper system function.
In the absence of NFC tag, the user may manually enter the lot and Barcode number present on the strip packaging using the keypad on the touch screen. A stylus with a rubber capacitive tip may be used to facilitate typing. 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. Note: The Battery is not User replaceable.
If you participate in a testing service, your service provider will provide you with all the necessary testing accessories. If you run out of testing supplies, please contact the service provider that gave you your meter for more supplies.
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/OFF the meter, press and hold Power Button. To Enter/Exit Sleep Mode press the button twice quickly. Cancel or return to previous screen Go to the home screen View additional menu Common Keypad input: a and b) is the input completion button.
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. Home Screen: a) Test Icon- Directs User to Test Strip information screen and subsequently to testing screen b) Control Icon- Allows User to select between High and low control tests.
3. 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 • 500 control test results with date and time • 1000 Operator accounts Lithium Battery Rechargeable Lithium Polymer Battery (3.
4. Performance Characteristics Expected Values: Results are reported in INR units equivalent to the plasma reference method. For PT testing, variations in the source of thromboplastin may cause some differences in results between methods. 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.
5. Warnings and Precautions • Patients taking Warfarin (Coumadin) and other oral blood thinners should consult with their healthcare provider before adjusting their dosage. • Patients should consult with their doctor for their appropriate INR therapeutic range. • Patients who have recently taken or are currently taking any type of Heparin or Low Molecular Weight Heparin anticoagulant should not use this test system and should consult their doctor.
• Use only fresh fingerstick capillary blood for testing. The blood should only come in contact with the products provided with the Coag-Sense PT/INR system. Other products may have anticoagulant agents on their surfaces and result in unreliable test results. • Squeezing the fingerstick site excessively (milking) releases interstitial “tissue layer” fluid that can cause unreliable results. • The fingerstick site can be washed with warm water and soap, and then completely dried.
• The meter is a delicate instrument, and should be handled with care. Dropping or other mishandling may cause damage to the meter. If this should occur, call Technical Support. • Do not allow any liquids to spill on the meter. If this should occur, call Technical Support. • Do not put the meter in liquid. Do not allow liquids to get into any of the connectors or plugs on the meter. • Only use the method provided in this User Manual to clean the CoagSense PT/INR meter.
CoaguSense, 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. If this occurs, unplug the power supply from the back of your meter, wait 5 seconds and plug it back in. Normal operation should return, but you may have to reset the time and date. • DO NOT OPEN THE METER. Do not attempt to repair or modify this meter.
• PT Test Strips, Control Strips, and Control Strip Activating Solution are perishable goods with a limited shelf life. Do not use any of these items if the expiration date has passed. • Refer to the package insert that is supplied with each box of test strips for more information.
6. 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. Electronic device. Dispose of unit properly.
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. Operating conditions are between 65ºF and 90ºF (18ºC and 32ºC). The meter will not allow a test to proceed until the meter is at room temperature. • Relative humidity should be between 10% and 85%, without condensation, for testing.
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. These User settings help the User to configure their PT/INR meter. No. Action Device Information Setting 1.
No. 2. Action Software Version Update Image guided instruction 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. c) User may choose to Reboot the meter after the download or push the reboot to a later time. Device Settings 1.
No. 2. Action Theme: User chooses from Mono/Blue/Color 3. Language Setup Image guided instruction Note: The default language is set to English. 4. Date Format Setup 5. Time Format Setup 6. Date and Time Setup Note: The time automatically adjusts for daylight savings time.
No. 7. Action Time Zone Setup Image guided instruction 8. Brightness: User chooses from range of 1-7 9. Sound Setting: User chooses to Turn sound ON or OFF 10. Target Range Setup 11. Alarm: User can set alarm as a reminder function with Time and set to repeat on selected days of the week. User may edit/ delete an alarm at any time.
No. Action Communication Settings 1. 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. 2. Image guided instruction Wireless (Wi-Fi) Setting: This screen displays icons that a) Scan for Wireless networks nearby b) Wireless ON/OFF icon Clicking the ‘Connect’ icon will require User to input passphrase to connect to the network. 3.
No. 4. Action Wired Setting: Setup wired network connection by inputting the fields displayed in the screen. Image guided instruction Note: If the connection method is DHCP, the contents are automatically assigned if a network with the DHCP server is plugged in. 5. 6. Bluetooth Setting: This screen displays icons that a) Scan for Bluetooth enabled devices nearby b) Bluetooth ON/OFF icon c) Bluetooth broadcast icon This screen displays the list of scanned Bluetooth enabled devices.
No. 8. Action 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.
8. Performing a Control Test There are 2 low control strips, 2 high control strips and a control strip activation solution shipped with each Coag-Sense 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. Please note that your home testing service provider may not include control strips in your supply shipment. Note: The following directions are for running a low control strip.
No. 3. Action Strip lot confirmation screen displays the Lot information of the strip that was last recorded. Proceed with testing if the control strip is from the same lot.
No. 4. Action Open the packaging of the selected control strip by tearing the notched end. 5. 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. 6. The meter warms the strip (for 25 seconds) to operating temperature, display shows a countdown in seconds. Note: Do not apply the control activation solution until the warm-up is complete and the meter display shows ‘Apply Control Solution’.
No. Action solution flow stops at white plug. 9. The meter beeps once and displays “Apply Control Solution” when it is ready for the control strip activation solution. Note: You now have up to 2 ½ minutes to apply the activation solution to the control strip. Rest hand on meter or counter top to steady. Insert transfer tube tip into sample application well of test strip, touching tip down at flashing green light in front of wheel. Depress black plunger completely to dispense the activation solution. 10.
No. 11. Action When testing is complete, the Pass/Fail results are displayed in PT units. Date and Time is also displayed. Image guided instruction Note: Control test results only display PT seconds, this is to avoid confusing control strip INR results with patient test strip INR results. 12. Repeat Steps 3-12 using the ‘High control strip.’ 13. Once the controls have been successfully tested, remember to remove and discard the control strips. You can now proceed to testing blood samples.
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. Before you prick the finger, warm your hand by washing it in warm water, holding it under their armpit, or by using a hand warmer.
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. • There are no bubbles or air pockets in the tube or sample. WARNING: Patient samples, controls, used test strips, transfer tubes and lancets are potentially infectious. Dispose of strips and collection devices using universal precautions. No. 1.
No. 4. Action 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”. A minimum of 10µl of collected blood sample is required. Image guided instruction Note: The blood should flow freely. If it doesn’t, gently squeeze the finger to get it started.
No. 6. Action Once you have collected the blood sample, IMMEDIATELY put it into the sample well on the test strip. See “Performing a PT Test” section of this manual. Image guided instruction WARNING: If there is a bubble or an air pocket present in the blood sample in the transfer tube, start the test over with a fresh fingerstick on a different finger.
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 steps below to perform a patient test: No Action Image guided instruction 1. Turn the meter ON by pressing and holding the (POWER) button on the right side of the meter. 2. 3. After startup and selfcheck, the display will show the Home Screen. To perform a Patient test, press the Test icon on display screen.
No Action If NFC tag information is not available, you may manually enter the Lot # and Barcode # using the keypad on the touchscreen into the respective fields. Image guided instruction 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. 4. Open the packaging of the test strip by tearing the notched end. 5. Holding the round end, gently push the strip completely into the meter.
No Action Image guided instruction While the meter is warming up, get ready to perform a fingerstick. See “Collecting a Fingerstick Sample” section in this manual. When the warm-up is complete, the meter beeps (if sound is turned ON) the screen displays ‘Apply Sample’ message. Note: You now have up to 2 ½ minutes to perform a fingerstick and apply the sample to the test strip. 7.
No 9. Action 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 date and time of the test. Image guided instruction Note: Memo field allows you to make notes such as medication or diet change along with the results. Upon clicking the Check mark icon, the main screen is displayed.
No Action Setting) the meter powers itself OFF. Image guided instruction WARNING: Unexpected results An unexpected result may include any result that falls outside the patient’s therapeutic target range, or a result that falls inside the target range but is not consistent with the patient’s current health status (e.g. patient is experiencing bleeding or bruising).
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. This meter records all test results, i.e. patient tests, and control tests. Memory is not lost if there is a break in power for any length of time.
No. 4. Action 4Clicking the chart icon displays the test results for the selected time interval. Note: The target range lines are set in "Settings>Device Settings>Target range". 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. 5. 5When an individual result is viewed, a memo can be added or changed and the result can be printed to an optional portable printer.
12. Printing With the portable printer (optional accessory) available from CoaguSense, results from the Coag-Sense meter memory can be printed on thermal paper. What you’ll need: • Coag-Sense meter • Optional Portable Printer, Catalog # 03P52-55 • 2” Thermal Paper, Catalog # PD99906-OM Follow the general steps below for printing results. Steps may vary slightly depending upon the model of printer purchased. No. Action Image guided instruction Plug the USB cable from 1.
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 home computer printer.
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. If this meter is connected to a local area network, the network must be protected against unauthorized access.
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. ambient temperature), frequency of use, and test duration. Note: The Battery is not User replaceable.
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. 67619-12) for a contact time of 1 minute to pre-clean blood and other body fluids.
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 than One Person Poses Risk for Transmitting Bloodborne Pathogens: Initial Communication” (2010) http://wayback.archiveit.org/7993/20170111013014/http://www.fda.gov/MedicalDevices/Safety/ AlertsandNotices/ucm224025.
18. Troubleshooting The Coag-Sense Meter continually checks its systems for unexpected conditions. These may arise because of defective components or consumables, environmental factors or due to User handling and procedure errors. 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) Solution If the message displays again contact Technical Support. DETECT PROBLEM There may be a problem with the strip insertion or with the motor carriage in the meter. Take the strip out and reinsert holding the back of the instrument steady with 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.
Meter Display Possible Cause(s) Solution to 32ºC) and allow meter time to adjust to correct temperature. Repeat testing. Turn meter off then on again after 5-7 minutes Try again with another strip. If the display persists, contact Technical Support. TEST STRIP EXPIRED SEE MANUAL The lot of strips have expired. NO SAMPLE DETECTED Either no sample or not enough sample was applied to the strip within 2 1/2 minutes after the “Apply Sample” message was displayed.
Meter Display CONTROL FAIL-CLOT TIME TOO SHORT Possible Cause(s) Solution in the sample or not allowing control activation solution to completely fill transfer tube. If the error message persists, contact your service provider. This may be due to a problem with the shipment/storage of the control strips or the control activation solution. Plasma on control strips is sensitive to exposure to temperatures outside the storage range. This does not indicate meter malfunction.
Meter Display Possible Cause(s) temperatures outside storage range. CLOT TIME TOO SHORT Solution the This does not indicate meter malfunction. The clotting time was very short and out of testing range (<8 seconds). Repeat the entire procedure (including fingerstick on a different finger) with a new strip. An air bubble was detected in the sample. Lancing the finger before ¨Apply Sample¨ displayed on screen.
Meter Display Possible Cause(s) Solution and contact Support. LOW BATTERY The meter battery is low Technical The meter can complete the 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 power ON Insufficient Battery to Power ON. Check if the power adapter (provided with the meter) is connected to the port in the Meter and the wall socket.
Issue Possible Causes Solution Display Screen Flickers Check Battery level and if issue persists, contact Technical Support. Touch screen not responding Dropping or subjecting the meter to strong shocks. Contact Technical Support. Touch screen cracked Dropping or subjecting the meter to strong shocks. Contact Technical Support. Using pointed or sharpedged objects other than the recommended ‘finger’ or rubber stylus to touch the screen elements.
Issue Possible Causes Solution Alternately, if you have additional inventory of the test strip kit from the same kit lot, use the NFC tag from that box(es). NFC Tag Issues: Improper scanning of the NFC tag. • NFC tag not working. • Scanned information does not match the information on the strip packaging Faulty NFC Tag scanner in the meter. Touch or bring the NFC tag to proximity of the NFC Tag scanner.
19. 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. WARNING: Failure to comply with the User Manual could lead to inaccurate PT/INR results which could lead to incorrect medication dosing which could lead to injury or death.
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, Box of 50 03P56-50 Coag-Sense Control Strip Kit -10 03P69-10 Sample Transfer Tubes with Plungers, vial of 54 03P52-54 Sample Transfer Tubes with Preloaded Plungers, vial of 54 03P52-55 Single-Use, 21g 2.2mm depth Auto Safety Lancets - Box of 100 03P58-04 AC Power Adapter – U.S.
21.
Index O Sound Setting, 22 Squeezing the Fingerstick Site, 13 System Description, 3 System Settings, 19 Operating Conditions, 18 P Performance Characteristics, 11 Performing a Control Test, 26 Performing a Patient Test, 35 Power, 40 Power ON/OFF, 18 Printing, 42 PT, 38 T Target Range Setup, 22 Test Strip, 6 Time Zone Setup, 22 Troubleshooting, 48 U R Unexpected results, 39 User Settings, 19 Reordering Information, 58 Reset button, 4 Room Temp Incorrect, 48 W Warnings and Precautions, 12 Warranty, 57 W
Technical Support CoaguSense, Inc. 48377 Fremont Blvd., STE 113 Fremont, CA 94538 USA Toll Free: 1-866-903-0890 E-Mail: techsupport@coagusense.com CoaguSense, Inc.
