No part of this publication may be reproduced, transmitted, transcribed, stored in a retrieval system or translated into any language or computer language, in any form or by any means, including, but not limited to, electronic, magnetic, optical, chemical, manual, or otherwise without written permission of CoaguSense. CoaguSense has made every reasonable effort to ensure that all the information contained in this manual is correct at the time of printing.
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 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.
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.
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. The Coag-Sense Meter has been designed with multiple internal systems to ensure proper system function.
reads the data stored in the NFC Tag and auto populates the relevant test strip kit lot information on the touch screen. 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 Professional System can be operated only with the power adapter provided. The power adapter also serves as a charger.
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 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-
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. To Enter/Exit Sleep Mode press the button once quickly and press the button again and hold for few seconds.
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 IconDirects 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 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.
• Do not pull the strip out while the wheel is spinning. STOP the test, meter will display “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, which are designed to provide a reasonable protection against harmful interference when the equipment is operated in a clinical or home environment.
precautions regarding EMC and needs to be put into service according to the EMC information provided in this manual.” • “Portable and mobile RF communications equipment can affect 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.
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. Note that all Settings options will only be available when logged in as Admin.
No. 2. Action 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. 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 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 (WiFi), 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. Wireless (Wi-Fi) Setting: This screen displays icons that a) Scans 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: Image guided instruction Setup wired network connection by inputting the fields displayed in the screen. Note: If the connection method is DHCP, the contents are automatically assigned if the network with the DHCP server is plugged in. 5. 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. 6.
No. Action External Connection 8. 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 9. QC Lock Settings: If a Control test (High Control or Low control) does not produce a result, or if the result is outside of the target value range, the meter can be locked from further patient testing. The frequency for required testing can be set.
No. 11. Action 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 field. b) displays the list of User accounts. c, d) lets you add and delete user accounts. Image guided instruction Edit Administrator Login Note: User Management is only visible in the Admin login view. 12.
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. Coag-Sense User Instructions recommends testing one set of Controls (High and Low) per new Lot# of Patient Test Strip Kits immediately upon receipt of shipment.
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.
2. No. 2. Action Press the Login icon. User is now directed to enter login credentials or scan operator barcode using a standard barcode scanner. Image guided instruction Note: To configure your meter for Auto login please contact technical support. 3. 3. Successful login directs the user to the Home screen. Press the Control icon on display icon. 4. 4. Select from the following two options as applicable; Low Control Test or High Control Test. 5.
No. Action Barcode # (eight-digit 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. Contact your Coag-Sense distributor for help with reordering. 6. 6Open the packaging of the selected control strip by tearing the notched end. 7.
No. 9. Action 9Insert 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). 10. 1Open the control activation 0solution and hold at an angle to allow insertion of the transfer tube. Insert transfer tube into control activation solution. Let capillary action fill until solution flow stops at white plug. 11.
No. 12. Action 1When the control activation 3solution is properly applied and detected, the flashing green light will turn off, and the meter displays ‘Testing Please Wait’. Image guided instruction Note: If this screen is not displayed within 8 seconds not enough solution was applied. Remove the strip. Retest with a new control strip. DO NOT attempt to add more solution to the strip. 13. 1When testing is complete, 4the Pass/Fail results are displayed in PT units. Date and Time are also displayed.
9. Collecting a Fingerstick Sample Tips for a Successful Fingerstick • Make sure that you have all you start. the supplies 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: No. Action Image guided instruction 1. Turn the meter ON by pressing and holding the (POWER) button on the right side of the meter.
No. 4. Action 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 number) will auto populate. 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. Press the forward button.
No. 7. Action 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. 8. The meter warms the strip (for 25 seconds) to operating temperature. The display shows a countdown in seconds. Image guided instruction 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.
No. 11. Action 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. DO NOT attempt to add more sample. Stop the test and retest with a new strip and fingerstick. 12. 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.
No. “Printing” manual. Action section Image guided instruction in this 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. 15. Turn the meter OFF by pressing and holding the POWER button when you are finished testing. If left unattended for a set time, (User preferred Setting) the meter powers itself OFF.
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). What can cause unexpected results: Certain prescription drugs (for example, heparin) and certain overthe-counter medications (for example, antibiotics) can affect the action of oral blood thinners and the INR value.
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. Note: The memory does not store patient ID or operator ID for any Stat test performed. Follow the steps below to perform an Stat test: No.
No. Action respective fields. Press the forward button. Image guided instruction Note: Make sure the expiration date on the strip packaging has not passed. Contact your Coag-Sense distributor for help with reordering. 3. 3Open the packaging of the test strip by tearing the notched end. 4. 4Holding 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. 5.
No. 8. Action 7IMMEDIATELY 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 plunger completely to apply blood sample. Discard the sample transfer tube in a biohazard waste container. 9. 8When the blood sample is detected, the meter displays a ‘Testing Please Wait’ message.
No. 11. Action 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.
12. 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, control and Stat tests.
No. 3. Action Successful login directs the user to the Home screen. Press the Results on display screen. 4. 2The ‘Results’ screen lists Patient test results and Control test results. 5. 3User can select from the various results stored in memory to view details of that results. 6. 4User can filter and view test results for a specific Patient Identifier by clicking on the Show Results of History button. Note: User may choose to list result history for a patient by selecting Patient ID.
No. 7. Action 5Clicking the chart icon displays the test result for the selected patient in a chart/list output. Note: 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.
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.
No. 3. Action User may choose from three different printer connection modes. Network and Bluetooth connection modes will require configuration using the setup icon prior to printing. Press Print to print the result. Image guided instruction 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.
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 CoagSense 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. It must not be linked directly to any other network or the Internet.
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. If a critical update is available, the meter may require the installation of an update prior to proceeding with testing.
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.
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. 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.
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 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. Meter date correctly. is not set Verify the date setting on the meter is current. 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. 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 ¨Apply Sample¨ 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 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. Power Adapter not connected properly for charging the battery. Not pressing and holding Power button when turning meter on.
Issue Possible Causes Solution Touch screen not responding Prolonged exposure to direct sunlight. Avoid prolonged exposure to direct sunlight, as it may reduce life expectancy and functionality of the display. Dropping or subjecting the meter to strong shocks. Contact Technical Support. Dropping or subjecting the meter to strong shocks Contact Technical Support.
Issue Possible Causes Solution NFC Tag Issues: Improper scanning of the NFC tag. 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.
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.
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.
20. 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, 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 Motor Problem, 56 STAT Test, 41 System and User Settings, 18 System Description, 3 N Near Field Communication (NFC) Tag, 5 Network Connectivity and Security, 50 No Sample Detected, 57 Normal Range, 11 T Time Zone Setup, 21 Troubleshooting, 55 U Unexpected Results, 40 User Accounts, 25 User Management, 25 O Operating Conditions, 17 P W Performance Characteristics, 11 Performing a Control Test, 27 Performing a Patient Test, 35 Power, 45 Power ON/OFF, 17 Power Supply, 6 Printing, 48 PT Seconds, 38,
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.
