USER’s Manual COAG-SENSE® PT3 PROTHROMBIN TIME(PT)/INR MONITORING SYSTEM
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Table of Contents Table of Contents .............................................. 3 1. Introduction ............................................ 1 2. System Description................................. 3 3. Meter Specifications ............................. 12 4. Performance Characteristics ................. 14 5. Warnings and Precautions .................... 15 6. Hazards and Symbols........................... 20 Directions for Use ........................................... 21 7. Meter Setup............
1. Introduction The Coag-Sense® PT3 Prothrombin Time (PT)/INR Monitoring System Intended Use The Coag-Sense PT3 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.
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 LCD screen that shows results, information, icons and results recalled from memory. To select an option, gently click on button below the screen. There are four buttons, SET, SCROLL UP, SCROLL DOWN and RETURN or Previous Screen Button. The Power ON/OFF button is located on the top right side of the meter. The NFC (Near Field Communication) Tag scanner is a built-in scanner that is used to scan the NFC card containing the strip (Control and Test Strip) data.
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. When powered ON, the meter runs an extensive selfcheck protocol to ensure, for example, that operating temperature, timing functions, battery level and optical and mechanical functions are within specification.
Battery: Coag-Sense PT3 PT/INR Professional System is powered with 4 AA batteries. Note: The battery is user replaceable. To save power, the meter automatically powers off by itself if left unattended for a set time (user configurable). When the meter powers off, all results obtained up to that point remain in the memory.
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 Sample Transfer Tubes w/ plungers Package Insert Qty 50 2 2 1 1 54 1 • Following are standard medical supplies that are required with each use: • Gauze • Isopropyl alcohol or alcohol wipes, • Single-Use- 21g Auto Safety Lancets, •
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 its description are provided in ‘Troubleshooting’ section.
Image Description Settings Blue Tooth Sound Page 9
Thermometer Battery NFC Tag-Reader Apply Sample No Sample Detected Error Page 10
Memory Insert/Remove Strip Control Hi/Low Pass/ Fail Result in Range/Out of Range Date Time Page 11
3. Meter Specifications Operating Temperature 64.4°F to 89.6°F (18°C to 32°C) Operating Humidity 10% to 90% (without condensation) Storage Temperature 32°F to 122°F (0°C to 50°C) Storage Humidity 20% to 80% (without condensation) Altitude 10.000 ft (3,048 m) above sea level Memory Capable of storing up to, • 500 test results with date and time Battery 4 AA Batteries Battery Capacity Minimum 100 tests Power Output 6.0V, 1.
NFC 13.56MHz Equipment Classification Internally powered when operated with battery. IPX0 rating.
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 This test system is not recommended for patients who have recently taken or are currently taking any type of Heparin anticoagulants. 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 expiration date.
If any alcohol remains (or is re-introduced) on the finger, it may cause unreliable results. • Do not use wipes containing chlorhexidine gluconate, as it may produce unreliable results. • The quality of fingerstick and the sample delivery technique are important to the test results. If there is a question about the sample or sample collection, obtain a new strip, repeat the fingerstick on a different finger, and test again.
• This equipment is tested to meet the limits for medical devices, which are designed to provide a reasonable protection against harmful interference when the equipment is operated in a clinical or home environment. If not installed and used in accordance with these instructions, it may cause harmful interference to other devices in the vicinity.
Test Strips/Control Strips/Control Strip Activating Solution • The test strips are designed for single use only. Do not reuse the test strips. • Patient samples, controls, used strips, transfer tubes and lancets are potentially infectious. Discard used materials in a puncture resistant, biohazard waste container using universal precautions. • PT Test Strips, Control Strips, and Control Activating Solution (CAS) are perishable goods with a limited shelf life.
FCC Caution: Any changes or modifications not expressly approved by the party responsible for compliance could void the user’s authority to operate this equipment. This device and its antenna(s) must not be co-located or operation in conjunction with any other antenna or transmitter. IMPORTANT NOTE: FCC Radiation Exposure Statement: This equipment complies with FCC radiation exposure limits set forth for an uncontrolled environment.
6. Hazards and Symbols Warning: This indicates a warning or precaution, requiring special attention. Class II Equipment. 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 64ºF and 90ºF (18ºC and 32ºC). The meter will not allow a test to proceed unless it is within the operating temperature range. • Relative humidity should be between 10% and 90%, 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. If the date and time have not been set before on the meter or the setting has been lost, the display looks like this with blinking characters.
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. Note: The following directions are for running a low control strip. When this procedure is complete, run a high control strip. The controls may be run in any order.
3. Scan the NFC tag against the NFC Tag scanner on the meter, the Lot # (six-digit number) will auto populate. 4. 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 holder. 5. When the strip is correctly inserted, meter starts warm-up cycle and the display shows a countdown of the time remaining. 6. The meter beeps once when it is ready for the control strip activation solution. 7.
Note: To avoid confusing control strip INR results with patient test strip INR results, the high control test will display the control result in PT seconds only. Note: If anything other than this is displayed, refer to the “Troubleshooting” section. Note: If control test fails, repeat the test with a new strip. If the control test continues to FAIL, please contact your POC testing administrator or Coag-Sense Technical Support for assistance.
9. Collecting a Fingerstick Sample Tips for a Successful Fingerstick • Make sure that you have all the supplies you start. needed before ▪ 21g Lancet device (Single use, auto disabling) ▪ Sample Transfer Tubes ▪ Sterile alcohol prep pads ▪ Gauze square and Band-Aids ▪ Biohazard waste container (SHARPS) • For fingerstick blood testing, increasing the flow of blood in the finger will help you capture a good drop of blood.
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 the strips and collection devices using universal precautions. No. 1.
No. 3. 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.
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. Wear gloves and follow all applicable hygiene and safety procedures. Follow the below steps to perform a patient test: Follow these steps to perform a test on a low or high control. 11. Make sure that the meter is on by pressing the POWER button on the top right side of the meter. 12.
16. 17. The meter beeps once when it is ready for the sample. 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. Depress the plunger completely to dispense blood sample. 18. When testing is complete, the results are displayed in INR units.
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 500 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.
12. Meter Software Update If a critical update is available, the meter may require the installation of an update prior to proceeding with testing. Make sure to check if the battery is charged enough before performing an update. If the battery’s charge is not enough and then the meter is abruptly turned off during update, an error may occur on the meter. Software can be updated connecting meter to a laptop using a USB Cable.
13. Battery Turn the meter upside down. Remove the battery door by pressing on the battery door release. Remove the old batteries and replace with 4 new standard 1.5V AA alkaline batteries. Replace the battery door. Properly dispose of old batteries . Note: The Battery is User replaceable. When the battery is running low the status bar on the touchscreen of the meter displays a red indicator in the ‘Battery status’ icon. The touchscreen displays a ‘Low Battery’ warning.
14. 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.
15. 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 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 TEST STRIP EXPIRED SEE MANUAL The lot of strips have expired. Use a different lot of strips that has not expired. NO SAMPLE DETECTED Meter date correctly. is not set Verify the date setting on the meter is current. Either no sample or not enough sample was applied to the strip within 2 1/2 minutes after icon was displayed. This can also happen if sample is applied on the strip but outside of the sample application well.
Meter Display Possible Cause(s) Solution An air bubble was detected in the control activation solution sample. activation solution sample before applying to test strip. The sample transfer tube was not filled with the control activation solution to the white plug CONTROL FAIL-OUT OF RANGE Ensure that the tube is filled to the white plug. Depress black plunger completely to dispense the control activation solution sample.
Meter Display Possible Cause(s) Solution CLOT TIME TOO SHORT 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 icon is displayed on screen. Taking too long to collect the sample in transfer tube (make sure of using 21g needle lancet for good flow of blood flow).
Meter Display Possible Cause(s) Solution should be replaced with new one. General Troubleshooting Issue Possible Causes Solution Meter does not power ON Insufficient Battery to Power ON. Install new batteries. If issue persists, Technical Support. contact Not pressing and holding Power button when turning meter on. Cannot insert strip completely Accumulation of dirt, dust, control activation solution, or blood in the strip insertion area.
Issue Possible Causes Solution 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. If the issue persists enter the strip information manually into the touchscreen to perform the current test.
16. Warranty Limited One (1) Year Warranty Use of the Coag-Sense PT/INR System The Coag-Sense PT3 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.
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.
17. Reordering Information For a description of the products listed below, please see the information above. Product Catalog # Coag-Sense PT3 PT/INR Professional System 03P83-01 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.
Discharges (ESD) ±2 ㎸, ±4 ㎸, ±8 ㎸, ±15 ㎸ Air 10 V/m 80 ㎒ to 2.7 G ㎐ 80%, 1 ㎑ AM Radiated RF electromagne tic Fields IEC 61000-43:2006+ A1:2007+A2:2010 Enclosure Electric Fast Transients and bursts IEC 61000-44:2012 AC Mains ±2 ㎸ AC, 100 ㎑ PRR Surges IEC 61000-45:2014 AC Mains ±0.5 ㎸, ±1 ㎸ L1 to L2 (DM) RF Wireless Comm. (Refer to test report clause 7.
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T Troubleshooting, 36 U Unexpected Results, 30 W Warnings and Precautions, 15 Warranty, 43 Wheel Problem, 36
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.
