Coag-Sense Users Manual
Contents
1. The Coag Sense Meter Bottom View Monitoring System Use Only Page 10 For In Vitro Diagnostic Use CoaguSense Inc System Description The Coag Sense Meter Rear View Data Printer Port Application Area Green light Bar Code flashing when Faces down when ready for sample inserted into meter CoaguSense Inc For In Vitro Diagnostic Use Page 11 Coag Sense Prothrombin Time PT INR Monitoring System Professional User s Manual 3 Reordering Information For a description of the products listed below please see the information above Product Catalog Coag Sense PT INR Professional System 03P60 01 Coag Sense Test Strip Kit Box of 50 03P56 50 Coag Sense Control Strip Kit 10 03P69 10 Sample Transfer Tubes Pack of 54 03P53 54 Lancets Normal Depth Box of 100 03P58 03 AC Power Adapter 03P64 01 4 Warnings and Precautions A General e This test system is not recommend for patients who have recently taken or are currently taking any type of Heparin anticoagulant Test Site and Blood Sample e The Coag Sense PT INR system is for in vitro diagnostic use only Page 12 For In Vitro Diagnostic Use CoaguSense Inc Warnings and Precautions e The Coag Sense meter will not produce a result if the test strip is past its expiration date e The quality of the blood sample can affect PT test results A blood sample of poor quality can produce unrelia2. Warnings and Precautions e Store and use the Coag Sense PT INR system following the instructions in this manual e This equipment is tested to meet the limits for medical devices which is 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 If this equipment does cause harmful interference to other devices which can be determined by turning the equipment on and off the user is encouraged to try to correct the interference by one or more of the following measures Reorient or relocate the receiving device Increase the separation between the equipment Connect the equipment to an outlet on a circuit different from that to which the other devices are connected e Any equipment connected to the data port must be certified to IEC 60601 1 If you connect any equipment that is not recommended by CoaguSense you are responsible for meeting the requirements of this standard e Inthe unlikely event of an electric power surge i e severe static discharge during a thunderstorm when using the optional AC 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
3. Note If any display other than the one shown is visible such as CLOT TIME TOO SHORT or NO CLOT DETECTED refer to the Troubleshooting section 12 Record the results Then remove the test strip Throw it away ina 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 CoaguSense Technical Support Turn the meter off by pressing the POWER button when you are finished testing If left unattended the meter automatically turns off in a few minutes The last 100 test results are stored in memory with the time and date Refer to Reviewing the Memory in this manual for more information CoaguSense Inc For In Vitro Diagnostic Use Page 29 Coag Sense Prothrombin Time PT INR Monitoring System Professional User s Manual innii 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 over the counter medications for example antibiotics can affect the action of oral blood thinners and the INR value Changes in diet lifestyle or taking nutritional supplements such as ginkgo biloba c
4. Meter Display Possible Cause Solution BAR CODE The strip was inserted Take the strip out and READ at an incorrect angle or reinsert holding the FAILURE speed back of the instrument steady with one hand There may be a while inserting the strip problem with the bar completely with the code on the strip or other hand Insert the with the meter stip vainga quick smooth motion The meter is in direct sunlight or near a high Move the meter indoors intensity light source into room lighting or away from light source If error persists try again with another strip If the message displays again contact Tech Support HEATER The meter is too warm Move the meter to a PROBLEM or too cold or there place that is within the CoaguSense Inc may be a problem with the meter For In Vitro Diagnostic Use operating temperature range of the meter 55 F to 95 F 13 C to 35 C and allow meter time to adjust to correct temperature Repeat testing Turn meter off then on again Try again with another strip If the display persists contact Tech Support Page 49 Coag Sense Prothrombin Time PT INR Monitoring System Professional User s Manual Meter Display Possible Cause Solution DETECT There may be a Take the strip out and PROBLEM problem with the strip reinsert holding the or with the meter back of the instrument steady with one hand while inserting the strip completely with the other hand I
5. light until b a clot forms and interrupts the beam of light The PT result is converted to an INR International Normalized Ratio using the calibration data stored in the meter INR is a mathematical correction of the PT result that adjusts for sensitivity differences among different PT systems The meter continues to check every feature of its operation through a series of self checks Page 8 For In Vitro Diagnostic Use CoaguSense Inc System Description Your Coag Sense PT INR Professional System Catalog number 03P60 01 comes supplied with Coag Sense PT INR Meter Coag Sense PT INR System Professional User s Manual Coag Sense PT INR System Professional Quick Reference Guide Four AA 1 5 V Alkaline Batteries not installed AC Power Supply Sample package of Single use Auto Sterile Lancets You will also need Coag Sense Professional Test Strip Kit 50 Catalog number 03P56 50 which includes 50 Patient Test Strips 2 Low Control Strips 2 High Control Strips 1 Control Strip Activation Solution 54 Sample Transfer Tubes Isopropyl alcohol or alcohol wipes Gauze Single use Auto Lancets 21 gauge box of 100 Puncture resistant bio hazard SHARPS container CoaguSense Inc For In Vitro Diagnostic Use Page 9 Coag Sense Prothrombin Time PT INR Monitoring System Professional User s Manual The Coag Sense Meter Top View Meter Display j i eA 4 Menu or Buttons A OS Strip Holder
6. Meter 11 Control Strips 39 MiniPipette 23 Customer Service 3 18 59 Motor Problem 50 D N Date 19 20 29 36 39 No Sample Detected 44 Detect Problem 49 Normal Range 51 E P E Mail Support 59 Performing a Control Test 21 Expected Values 51 Performing a Patient Test 26 Power 36 Printing 37 Page 56 For In Vitro Diagnostic Use CoaguSense Inc PT 29 PT Test Strip 26 R Remove Strip 44 Room Temp Incorrect 47 S Sharps Container 31 Squeezing the Fingerstick Site 13 System Description 8 CoaguSense Inc Index T Test Strip 11 Troubleshooting 44 U Unexpected Results 30 32 Ww Warnings and Precautions 12 Warranty 53 Wheel Problem 47 For In Vitro Diagnostic Use Page 57 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 IEC REP 48377 Fremont Blvd STE 113 EMERGO EUROPE Fremont CA 94538 USA Molenstraat 15 Peo foe aug 2513 BH The Hague The Netherlands Product Made in U S A t Part No 100220 CSI P N 100220 Rev AF
7. gently squeeze the finger to get it started Lowering the patient s hand and arm so that the fingertip is below the heart helps the blood drop form A WARNING Squeezing the fingerstick site excessively milking releases interstitial tissue layer fluid that can cause unreliable results CoaguSense Inc For In Vitro Diagnostic Use Page 35 Coag Sense Prothrombin Time PT INR Monitoring System Professional User s Manual Action Meter Display 7 When ready to collect the drop of blood hold the Sample Transfer Tube between your thumb and forefinger below the bulb being sure not to cover the air hole in bulb DO NOT v SQUEEZE THE BULB 8 With tube horizontal touch tip to bead of blood Let capillary action fill glass portion of tube until blood flow stops Squeeze finger to produce additional blood if require to completely fill glass portion of tube 9 Once you have collected the sample immediately put it into the sample well on the test strip See Performing a PT Test section of this manual JN WARNING If there is a bubble or an air pocket showing in the blood sample in the collection tube or tip start the test over with a new strip and fingerstick on a different finger Page 36 For In Vitro Diagnostic Use CoaguSense Inc Sample Collection and Transfer Methods 12 Reviewing the Memory The Coag Sense meter stores up to 100 results along with the date and time in i
8. time and date e DO NOT OPEN THE METER Do not attempt to repair or modify this meter The Coag Sense meter does not CoaguSense Inc For In Vitro Diagnostic Use Page 15 Coag Sense Prothrombin Time PT INR Monitoring System Professional User s Manual require any periodic maintenance and there are no user serviceable parts inside If you have problems please contact technical support or your health care provider to arrange for service Test Strips Control Strips Control Strip Activating Solution Page 16 The test strips are designed for single use only Do not reuse the test strips Patient samples controls used strips 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 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 For In Vitro Diagnostic Use CoaguSense Inc Hazards and Symbols 5 Hazards and Symbols Warning This indicates a warning or precaution requiring special attention Class Il Equipment The AC Adapter is double insulated Biological Risks Disposable items pose biological risks The strips and fingerstick materials should be disposed in appropriate biohazard waste containe
9. type connector available from CoaguSense at no charge e Citizen Thermal Paper PD99906 OM or 2 wide thermal labels Page 38 For In Vitro Diagnostic Use CoaguSense Inc Sample Collection and Transfer Methods Printing Test Results 1 Attach the Null Modem Adapter to the data port on the back of the Coag Sense Meter Connect the large DB9 end of the Citizen printer cable to the Null Modem Adapter Insert the small cable connector into the side of the Citizen printer Press and hold the green power button on the left side of the Citizen printer until the power light comes on Turn on the Coag Sense meter Press MEM The two most recent results in memory will be shown If you wish to go further back into the meter s memory to print a result press NEXT Continue to press NEXT until the desired result s are visible in the display Press PREV if you need to scroll back to more recent results Once you have the result s you wish to print displayed press PRINT To print the top result in the display window press PRN1 To print the bottom result in the display window press PRN2 If the results fail to print confirm that the printer is on as it automatically turns off after a few minutes If the printer turns off after pressing the PRN1 or PRN2 then the batteries in the printer are be too weak and should be replaced For assistance with the printing function call Technical Support at 1 866 903 0890 CoaguSense
10. 1 5V AA alkaline batteries The proper direction for battery placement is shown ona figure inside the battery compartment 4 Replace the battery door 5 Properly dispose of old batteries Page 42 For In Vitro Diagnostic Use CoaguSense Inc Replacing the Batteries 16 Cleaning and Disinfecting the Meter No maintenance is required other than routine cleaning and or disinfecting To clean the outside of the meter use a clean damp non abrasive cloth If instructions for use are properly followed patients should not come in direct contact with the Coag Sense meter thereby reducing the possible transmission of bloodborne pathogens between patients Sample should always be transferred from the patient to the meter using a new disposable sample transfer tube or disposable pipette tip The meter housing can be disinfected using a 10 bleach solution EPA reg No 5813 50 Apply the disinfecting product to a lint free cloth and wipe the meter or MiniPipette for a minimum contact time of 2 minutes The test strip is designed to contain the patient sample preventing it from entering the meter Do not clean disinfect inside the meter where the test strip is inserted cleaning this area should be avoided Please call Technical Support at 1 866 903 0890 if this area requires cleaning disinfecting CoaguSense Inc For In Vitro Diagnostic Use Page 43 Coag Sense Prothrombin Time PT INR Monitoring System Professional
11. ARTS NO WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE IS IMPLIED FROM THE SALE OF THE COAG SENSE PT INR SYSTEM NO WARRANTY EXPRESS OR IMPLIED IF ANY SHALL EXTEND FOR A LONGER DURATION THAN THE DURATION OF THE EXPRESS WARRANTY STATED ABOVE Instructions for Meter or Product Return Upon review and agreement with CoaguSense Customer Service you may be directed to return the unit Should this occur clean the outside surface using 10 bleach solution as described in the Cleaning and Disinfecting the Meter section The original packaging may be required for this purpose If this is not available a cushioned shipping box may be required CoaguSense Inc For In Vitro Diagnostic Use Page 55 Coag Sense Prothrombin Time PT INR Monitoring System Professional User s Manual A F AC Adapter 19 Fingerstick Sample 31 AC Power 39 40 Flashing Green Light 28 Air Bubbles 28 Alcohol Wipe 31 H B Hazards And Symbols 17 Heater Problem 48 Bar Code Read Failure 48 High Control Strip 21 25 Batteries 14 19 39 Battery Low 50 l Battery Too Low 50 Blood Flow 31 IEC 60601 1 15 Blood Mini INR 8 ood Minimum Amount 34 INR Results 29 G L Calibration 8 a Lancet 14 34 Cleaning the Metet 42 Liquid Problem 49 Clock 20 i Low Control Strip 21 39 Clot Time Too Long 46 M Clot Time Too Short 45 Collecting a Fingerstick Measuring Range 51 Sample 31 Memory 29 36 Control Out of Range 47
12. Coag Sense Prothrombin Time PT ANR Monitoring System Professional User s Manual Cjausense Copyright 2013 CoaguSense Inc All rights reserved 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 Coag Sense is a registered trademark of CoaguSense Inc Page 2 For In Vitro Diagnostic Use CoaguSense Inc Contacting CoaguSense Contacting CoaguSense If you have any questions or concerns with the Coag Sense Prothrombin Time PT INR Monitoring System please contact CoaguSense Technical Support at CoaguSense Inc 48377 Fremont Blvd STE 113 Fremont CA 94538 Toll Free 1 866 903 0890 E Mail techsupport coagusense com Note The Coag Sense Prothrombin Time PT INR Monitoring System meter is packaged in a special box Do not discard this box Re use the package to transport the meter or if directed by Customer Service to return it for testing The Coag Sense PT INR System may be used for multiple patient testing in a professional healthcare setting CoaguSense Inc For In Vitro Diagnostic Use Page 3 Coag Sense Prothrombin Time PT INR Monitoring System Professional User s Manual The Coag Sense Prothrombin Time PT INR Moni
13. Inc For In Vitro Diagnostic Use Page 39 Coag Sense Prothrombin Time PT INR Monitoring System Professional User s Manual 14 Control Strips Quality control is an important part of PT time testing Using the high and low control strips ensures you are performing the steps of the test correctly It also ensures that your Coag Sense System is working properly and that reagent in the test strips is working as expected Your Coag Sense test strip includes true control strips containing the same thromboplastin reagent as the test strip along with plasma of known INR One high and one low control should be tested before using a new PT test strip lot Controls should also be tested if you have unexpected results There are 2 low control strips 2 high control strips and one control activation solution vial shipped with each new box of test strips Additional controls may be ordered separately See Performing a Control Test in this manual 15 Replacing the Batteries It is not necessary to install batteries in the meter if the optional AC adapter is plugged into a wall socket However if no batteries are installed and the meter is unplugged or there is a power outage the time and date settings reset to the factory settings The meter is designed for AA 1 5 V alkaline batteries only It does not re charge these alkaline batteries when connected to AC power JN WARNING Use only AA 1 5 V alkaline batteries in the Coag Sense meter
14. Rechargeable batteries should not be used as they can result in damage to the meter Page 40 For In Vitro Diagnostic Use CoaguSense Inc Replacing the Batteries The AA 1 5 V batteries will last for approximately 300 tests if the meter is operating only on batteries The batteries may last through their shelf life if the optional AC power adapter is plugged in If the batteries are running low the meter displays a BATTERY LOW message The meter can run one or two additional PT tests but the batteries should be replaced as soon as possible You can plug the optional AC power adapter into a wall socket and replace the batteries later When the message BATTERY TOO LOW SEE MANUAL appears on the meter display the meter shuts off after a brief delay The batteries must be replaced or the meter must be connected to a wall socket with the optional AC power adapter to continue testing The meter time and date settings are lost and the meter will need to have the date and time reset See Setting the Time and Date in this manual Complete the following steps to replace the AA 1 5 V alkaline batteries 1 Turn the meter upside down 2 Remove the battery door by pressing on the battery door E releases CoaguSense Inc For In Vitro Diagnostic Use Page 41 Coag Sense Prothrombin Time PT INR Monitoring System Professional User s Manual 3 Remove the old batteries and replace with 4 new standard
15. Sample ccccceeeeeeeeees 31 Sample Collection and Transfer Methods Error Bookmark not defined 12 Reviewing the Memory cccceeesseeeeeeeteeeeeenaeeeeeenaes 37 TS PYG enrere iden ani aa iR 38 14 Qontrol Stips 2 2 h asin ene 40 15 Replacing the Batteries 2 40 16 Cleaning and Disinfecting the Meter c eeeee 43 17 Troubleshooting 0 0 ee eeeeeeeeneeeeeeeaeeeeeeaeeeeeeaeeeeeeaaes 45 18 Performance Characteristics essees eneee 52 19 Meter Specifications s esseeese eese eee resene nesr rerrnserneens 53 20 Warranty oeae RN 54 21 A i e E E E ET 56 Page 6 For In Vitro Diagnostic Use CoaguSense Inc 1 About This Manual 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 You must complete proper training on the Coag Sense PT INR system before you begin using the system It is also important to read this entire User Manual and the inserts that come with the disposable Coag Sense test strips This User Manual has different formats and symbols to distinguish warnings notes and meter buttons AN WARNING This indicates a warning or precaution Please read and understand all warnings and precautions They tell you about potential safety haz
16. Sample in this manual 6 When the warm up is complete the meter beeps once The screen looks like this Note You now have 2 2 minutes to apply the sample to the test Strip CoaguSense Inc For In Vitro Diagnostic Use APPLY SAMPLE psoe Page 27 Coag Sense Prothrombin Time PT INR Monitoring System Professional User s Manual Action Meter Display 7 Immediately after collecting the patient sample place the tip of the sample transfer tube at a 45 angle into the sample well on the 3 test strip where you see the oe flashing green light Gently touch the tip down onto the sample well 8 Slowly squeeze the bulb until the blood leaves the tube being careful not to introduce air bubbles into the sample Keep pressure on bulb while you pull your hand away to avoid back suction of sample 9 Discard the sample transfer tube in a biohazard waste container 10 When the sample is detected the meter TESTING display looks like this PLEASE WAIT Note w If this screen is not displayed either not enough blood sample was applied or the sample had air bubbles in it Remove the strip and retest with a new strip Page 28 For In Vitro Diagnostic Use CoaguSense Inc Performing a PT Test Action Meter Display 11 When testing is complete INR 2 2 the meter beeps once PT 22 2 The results INR and PT in seconds are shown on 10 18 13 8 50 AM the screen REMOVE STRIP
17. User s Manual After disinfecting the meter gloves should be removed and hands washed before proceeding to the next patient Please call technical support at 1 866 903 0890 with any cleaning or disinfecting questions JN 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 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 www fda gov MedicalDevices Safety AlertsandNotices ucm224025 htm CDC Clinical Reminder Use of Fingerstick Devices on More than One Person Poses Risk for Transmitting Bloodborne Pathogens 2010 http www cdc gov injectionsafety Fingerstick DevicesBGM htm Page 44 For In Vitro Diagnostic Use CoaguSense Inc Troubleshooting 17 Troubleshooting You may see the following error messages while using the Coag Sense meter This section discusses how to resolve most problems that you might encounter If you have any questions or problems during the troub
18. air bubbles If the same message repeats contact Technical Support Page 46 For In Vitro Diagnostic Use CoaguSense Inc Troubleshooting Meter Display Possible Cause Solution NO CLOT The sample clotting Visually confirm that no DETECTED time was very long and air bubbles are in the out of testing range sample and that the glass portion of the There was insufficient transfer tube is full sample transferred to before applying to test the test strip Possible strip causes include improper lancing 21g Release pressure on lancet required an air the transfer tube bulb bubble in the sample only after removing not allowing sample to transfer tube from completely fill glass sample application well portion of transfer tube or the sample Confirm that the patient was drawn back into has not recently taken the transfer tube heparin or other before removing tip contraindicated drugs from the test strip well listed on the test strip package insert Repeat the entire procedure including fingerstick with a new strip If the same message displays use an alternative testing method and contact Tech Support TEST STRIP The lot of strips has Use a different lot of EXPIRED SEE expired strips that has not MANUAL expired CoaguSense Inc Date is incorrect For In Vitro Diagnostic Use Verify the date setting on the meter is current Page 47 Coag Sense Prothrombin Time PT INR Monitoring Syste
19. an affect the action of oral blood thinners and the INR value Liver diseases congestive heart failure thyroid dysfunction Lupus antiphospholipid antibody syndrome APS and other diseases or conditions can affect the action of oral blood thinners and the INR value Be sure to confirm whether the patient has any of these conditions before you begin testing and any time there are changes in health patient status or medications after you have begun testing 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 other corrective actions Page 30 For In Vitro Diagnostic Use CoaguSense Inc Collecting a Fingerstick Sample 11 Collecting a Fingerstick Sample Tips for a Successful Fingerstick e Make sure that you have all the supplies needed before you start Lancet device Single use auto disabling Sample Transfer Tubes Sterile alcohol prep pads Gauze square Band Aids Biohazard waste container SHARPS e 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 have the patient warm their hand by washing it in warm water holding it under their armpit or by using a ha
20. ards and situations that may cause injury If you have any questions please contact CoaguSense Tech Support at 1 866 903 0890 USA Note Notes provide additional information that is useful or important All notes are displayed in italics Words in BOLD ALL CAPITALS refer to buttons on the Coag Sense meter CoaguSense Inc For In Vitro Diagnostic Use Page 7 Coag Sense Prothrombin Time PT INR Monitoring System Professional User s Manual 2 System Description The Coag Sense Prothrombin Time PT INR System is used for quantitative measurement of Prothrombin Time PT in fresh capillary whole blood The Coag Sense PT INR system is intended for use outside the body in vitro diagnostic use to test patients taking warfarin type oral anticoagulant blood thinning therapy who need to monitor clotting time The meter performs a self test when it is first turned on If there are any problems with the meter an error message is shown on the display Refer to the Troubleshooting section of this manual or contact Technical Support A test strip is inserted and heated in the meter prior to sample application The strip contains a tiny wheel with spokes that pull the sample into the reaction well The spokes quickly and completely mix the sample with the clot initiating component of the test strip The PT time is determined from when a the sample is drawn into the reaction well of the test strip and detected by a beam of
21. ble results Read the section on Collecting a Fingerstick Sample for more information e Blood samples must be applied to the test strip immediately after collection or the blood begins to clot causing unreliable results e The blood sample transferred to the test strip must be a minimum of 10 uL in volume Low sample volume may cause an error message e 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 anti coagulant agents on their surfaces and result in unreliable test results e Squeezing the fingerstick site excessively milking releases interstitial tissue layer fluid that can cause unreliable results e The fingerstick site can be washed with warm water and soap and then completely dried The site must be clean of all hand oils lotions and foreign matter which may cause unreliable results e f Isopropyl Alcohol IPA wipes are used wipe the fingerstick site with a gauze pad and make sure the site is completely dry If any alcohol remains or is re introduced on the finger it may cause unreliable results e 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 CoaguSense Inc For In Vitro Diagnostic Use Page 13 Coag Sense Prothrombin Time PT INR Monitoring System Profes
22. cting CoaguSense is too low the risk of blood clots increases If the INR is too high the risk of hemorrhaging increases The patient s physician will determine the most appropriate INR range for the patient depending upon the patient s indication and how they respond to the oral anticoagulant CoaguSense Inc For In Vitro Diagnostic Use Page 5 Coag Sense Prothrombin Time PT INR Monitoring System Professional User s Manual WE le We mO re ai Jal ts Contacting COaguSense ceccceceeeeeeseeceeceeceeeeeseaeeseneeeeneees 3 Table of Contents cccccesccesseeeeseeeeeeeeeesaeseseeeeneeeesseeseseeeeneeneees 6 1 About This Manual essesi 7 2 System Description cccccececeeeeeeeeeceeeeeseeeeesseeeeeneeeeaes 8 3 Reordering Information ccc eeeeeeeeeenteeeeeeneeeeeenaes 12 4 Warnings and Precautions ceeseeeeenteeeeeenneeeeeeaes 12 5 Hazards and Symbols cccccccseeeceeeeeeeeeeeseeeeeneeeeees 17 Directions fOr USC ccccceeceeeeeeeeeeeeneeeeeeeneeseseneeseeeeneeseeeeenes 18 6 Operating Conditions 20 2 0 cece eee eeeeeeeeeeeeeeeeeeneeteaes 18 7 Power On and Off ccccceeececeeeeeseeeeeeeeeeeeeeseaeeeeneeeeaes 19 8 Setting the Time and Date ecceeeeeeeeeteeeesteeeeneeees 19 9 Performing a Control TeSt 0 ceesceeeeeeeeeeeeeeeeeeeeeees 21 10 Performing a PT TeSt eee eecceeeeesneeeeenteeeeeeneeeeeenaes 26 11 Collecting a Fingerstick
23. ense Inc Power On and Off 7 Power On and Off Install the AA 1 5 V batteries which are needed to maintain the time and date settings See Replacing the Batteries for more information The AC adapter can be connected at this time Place the meter on a flat stable surface To turn the meter on Press the POWER button which is on the topside of the meter beneath the display To turn the meter off press the same POWER button again 8 Setting the Time and Date Action A CoaguSense Inc 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 The blinking characters may be changed by pressing to increase or to decrease When correct press NEXT to advance to the next character For In Vitro Diagnostic Use Meter Display 12 00PM 1 01 13 Press NEXT to advance to next character Page 19 Coag Sense Prothrombin Time PT INR Monitoring System Professional User s Manual Action 3 Once you have entered the correct date and time press DONE to exit this function Once the date and time are set the display looks like this If you need to change the date or time in the future press SET The meter display shows the set time and date Adjust the time and date by pressing to increase or to decrease When the time and date are correct press DONE when finished Meter Disp
24. er not enough solution was applied or the solution had bubbles in it Remove the strip Retest with a new control strip DO NOT attempt to add more solution to the strip 11 When testing is complete LO CONTL OK the display shows OK and PT 22 5 looks similar to this 10 18 13 8 01 AM REMOVE STRIP Page 24 For In Vitro Diagnostic Use CoaguSense Inc Performing a PT Test Action Meter Display Note To avoid confusing control strip INR results with patient test strip INR results control test results will display in PT seconds only Note The date and time shown in the display are examples only The date and time shown after actual testing is the current date and time Note If anything other than this is displayed refer to the Troubleshooting section Note Remember to repeat this entire procedure with a high 12 13 control strip When high control testing is HI CONTL OK complete the display shows PT 42 1 OK and looks similar to 10 18 12 8 05 AM this REMOVE STRIP Once the controls have been successfully tested remember to throw the control strips into a biohazard container You can now proceed to testing patient blood samples If you are not going to test turn off the meter by pressing the POWER button The opened control activation solution may be used until the expiration date CoaguSense Inc For In Vitro Diagnostic Use Page 25 Coag Sense Prothrombin Time PT INR Mo
25. ferences 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 0 Page 52 For In Vitro Diagnostic Use CoaguSense Inc Meter Specifications 19 Meter Specifications Operating Temperature 55 F to 95 F 13 C to 35 C Operating Humidity 10 to 85 without condensation Storage Temperature 4F to 122 F 20 C to 50 C Storage Humidity 10 to 95 without condensation Memory Capable of storing 100 tests with time and date Battery Quantity 4 of 1 5V AA alkaline batteries AC Input 120V AC Use with Coag Sense Adapter Only Power Output 6 0V 2 0A Blood Sample Size 10 12 uL Data Port RS232 Size 3 7 6 cm x 6 5 16 5 cm x 5 75 14 5 cm Weight With 4 AA 1 5 V alkaline batteries 1 8 Ib 658 g Equipment Classification Class II with external power supply Internally powered when operated with batteries IPXO rating A WARNING Use only the Coag Sense AC adapter or damage to the meter may result CoaguSense Inc For In Vitro Diagnostic Use Page 53 Coag Sense Prothrombin Time PT INR Monitoring System Professional User s Manual 20 Warranty Limited One 1 Year Warranty Use
26. lay 12 00PM 1 01 13 Press DONE when date and time are correct READY INSERT STRIP Press SET to adjust date and time again if necessary 8 00AM 3 07 13 Press DONE when date and time are correct Note The clock time does not adjust for daylight savings time The date format is mm dd yy Page 20 For In Vitro Diagnostic Use CoaguSense Inc Performing a Control Test 9 Performing a Control Test Control testing confirms the performance of both the meter and the test strips and should be completed for each new lot of test strips Control testing can also be run whenever the PT results are unexpected to make sure that the system is working properly There are 2 low control strips 2 high control strips and a control strip activation solution shipped with each test strip kit Extra controls may be ordered separately Follow these steps to perform a test on a low or high control 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 The meter will display and store the results in PT seconds only The meter does not use or require results from the contro strips prior to running a patient test strip If multiple boxes of test strips are purchased at the same time and they have the same lot number only one low and one high control from that lot needs to be tested JN WARNING Do not move o
27. leshooting process note the display wording and contact Technical Support at 866 903 0890 or email techsupport coagusense com Meter Display Possible Cause Solution REMOVE Meter turned off with Remove the strip and STRIP used strip in it begin again If no strip present Call Tech Support possible shipment damage NO SAMPLE Either no sample or Repeat the entire DETECTED not enough sample procedure including was applied to the strip within 2 1 2 minutes fingerstick on a different finger with a new strip CoaguSense Inc 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 For In Vitro Diagnostic Use e Apply the sample within 2 1 2 minutes after display of the Apply Sample message e Ensure that the transfer tube touches the sample well before dispensing sample Page 45 Coag Sense Prothrombin Time PT INR Monitoring System Professional User s Manual Meter Display Possible Cause Solution CLOT TIME The clotting time was Repeat the entire TOO SHORT very short and out of procedure including testing range lt 8 fingerstick on a different seconds finger with a new strip An air bubble was Visually confirm that no detected in the air bubbles are in the sample sample before applying to test strip Gently squeeze the transfer tube bulb until the blood exits being sure not to introduce
28. m Professional User s Manual CONTROL The control strip result Repeat test with OUT OF is outside of its another control strip If RANGE acceptable range This the second test is out of may be due toa range contact Tech problem with the Support shipment storage of the control strips or the Control strips should be control acivatlan tested immediately solution Plasma on upon receipt of your control strips have S shipment of new test limited shelf life and strips as they have a the clotting time will limited shelf life change when exposed to temperatures outside the storage range ROOM TEMP The temperature of the Move the meter to a INCORRECT room is either below or place that is within the SEE MANUAL above the operating operating temperature temperature range of range of the meter the meter 55 F to 95 F 13 C to 35 C and allow meter time to adjust to correct temperature Repeat testing WHEEL The test strip was Reinsert the strip PROBLEM inserted at an incorrect holding the back of the Page 48 angle or speed There may be a problem with the wheel on the strip or with the meter A used strip was inserted For In Vitro Diagnostic Use meter steady with one hand while inserting the strip completely using a quick smooth motion with the other hand If display persists try again with another strip If the message displays again contact Tech Support CoaguSense Inc Troubleshooting
29. nd warmer Ensure that the patient s hand is dry prior to testing e Do not use fingers with tight rings scars calluses or other features that prevent getting good access to the blood e One of the middle or index fingers on either hand is recommended e Gently squeeze or massage the finger to be lanced near the tip Good circulation can be seen if the patient s fingertip changes to a pinkish shade e Use a 21g 1 8 mm depth single use auto disabling lancet Smaller gauge shallow depth lancets i e diabetes 23g lancets should not be used Refer to CoaguSense Inc For In Vitro Diagnostic Use Page 31 Coag Sense Prothrombin Time PT INR Monitoring System Professional User s Manual the Lancet device instructions for more information on use e Lance the fleshy part of the fingertip just slightly left or right of the center Press lancet firmly against finger e For better blood flow you may have the patient hold their hand below their heart Squeeze the finger from the sides to open up the wound for proper blood flow if necessary to produce pea sized drop The best test sample is when e The blood is collected right after the fingerstick and put into the sample well without delay If the blood is not collected or tested quickly repeat with a fresh fingerstick and a new strip e There are no bubbles or air pockets in the tube or sample Aenean Patient samples controls used test strips and lancets are pote
30. nitoring System Professional User s Manual 10 Performing a PT Test A WARNING Place the meter on a stationary level surface for testing Do not move the meter or allow it to vibrate during a test Unreliable results may occur Wear gloves and follow all applicable hygiene and safety procedures Action Meter Display 1 Make sure that the meter is on by pressing the POWER READY button on the top of the INSERT meter STRIP Note w Ifan error message appears refer to the Troubleshooting section 2 Open a PT test strip package tearing at the notched end Remove the strip Set the package aside Note Make sure that the expiration date has not passed 3 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 Page 26 For In Vitro Diagnostic Use CoaguSense Inc Action 4 When the patient test strip is correctly inserted the display looks like this 5 The meter warms the strip The display looks like this The meter counts down the time remaining during the warm up cycle Note Do not apply any sample until the warm up is complete and the meter tells you do so Performing a PT Test Meter Display PAT STRIP DETECTED WARMING PLEASE WAIT 24 Warming count down in seconds While the meter is warming up get ready to perform a fingerstick See Collecting a Fingerstick
31. nsert the strip using a quick smooth motion Try again with another strip If the message persists contact Technical Support LIQUID There may be a Take the strip out and PROBLEM problem with the strip reinsert holding the or with the meter 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 Page 50 For In Vitro Diagnostic Use CoaguSense Inc Troubleshooting Solution Meter Display Possible Cause MOTOR There may be a Turn the meter off then PROBLEM problem with the strip back on Try again with or with the meter another strip If the message persists contact Technical Support BATTERY The meter batteries The meter can complete LOW need to be replaced the current test as well as one or two more tests However the batteries should be replaced as soon as possible BATTERY TOO The meter batteries Replace batteries to LOW must be replaced continue with testing CoaguSense Inc For In Vitro Diagnostic Use Page 51 Coag Sense Prothrombin Time PT INR Monitoring System Professional User s Manual 18 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 dif
32. ntially infectious Dispose of strips and collection devices using universal precautions Page 32 For In Vitro Diagnostic Use CoaguSense Inc Collecting a Fingerstick Sample Action Meter Display CoaguSense Inc For In Vitro Diagnostic Use Page 33 Coag Sense Prothrombin Time PT INR Monitoring System Professional User s Manual Action Meter Display 1 Have patient wash hands with soap and warm water Dry completely 2 Choose a site near the top of one of the middle fingers to lance Note Avoid the more sensitive area in the center Avoid any calluses or scars 3 Clean the fingertip with an alcohol wipe using one side for the first cleaning Use the second side for a final wipe 4 Dry the fingertip with gauze to remove any excess alcohol 5 Place the patient s on solid surface with the palm of the hand facing up Note w Residual alcohol will affect results Be certain that finger is completely dry Page 34 For In Vitro Diagnostic Use CoaguSense Inc Collecting a Fingerstick Sample Action Meter Display 6 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 skin Do not lance finger until meter displays APPLY SAMPLE A minimum of 10ul of collected blood sample is required Note The blood should bleed freely If it doesn t
33. 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 Limited Warranty CoaguSense warrants that the Coag Sense meter is free from all defects in material and workmanship for a period of one 1 year from date of purchase When the meter is used for the intended purpose and in the appropriate manner the remedy is repair or replacement at CoaguSense s option The warranty does not apply to a meter damaged by misuse alteration or tampering to either the hardware or software Contact Technical Support at 1 866 903 0890 for instructions THIS WARRANTY APPLIES ONLY TO THE METER COAGUSENSE S ENTIRE LIABILITY IN CONNECTION WITH THE METER REGARDLES OF THE LEGAL OR EQUITABLE BASIS OF ANY CLAIM IS LIMITED TO THE PURCHASE PRICE OF THE METER IN NO EVENT SHALL COAGUSENSE INC BE LIABLE TO THE PURCHASER FOR ANY INCIDENTAL CONSEQUENTIAL INCLUDING BUT NOT LIMITED TO LOSS OF INCOME OR PROFITS SPECIAL INDIRECT OR PUNITIVE DAMAGES ARISING FROM OR IN Page 54 For In Vitro Diagnostic Use CoaguSense Inc Warranty ANY WAY CONNECTED WITH THE PURCHASE OR OPERATION OF THE METER OR ITS P
34. r touch the meter while it is running a test Unreliable results may occur Note o If an error message appears consult the Troubleshooting section of this manual CoaguSense Inc For In Vitro Diagnostic Use Page 21 Coag Sense Prothrombin Time PT INR Monitoring System Professional User s Manual Action 1 Make sure that the power is on by pressing the POWER button on the top of the meter and the display looks like this 2 Open a low control package tearing at the notched end Remove the strip Set the package aside Note Make sure that the expiration date has not passed by checking the date on the front of the control package ae ba Exp 2014 08 Meter Display READY INSERT STRIP Coag Sense Low Control Strip For In Vitro Diagnostic Use Only 110564 Store a 32 C t M sore ze 2 pH 35 F CoaguSense Inc Made in USA CSI P N 100211 CSI ART 100206 Rev AB 3 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 4 When the strip is correctly inserted the display looks like this Page 22 For In Vitro Diagnostic Use LOW CONTROL DETECTED CoaguSense Inc Performing a PT Test Action Meter Display Note If anything other than this is displayed refer to the Troubleshooting section 5 The meter warms the strip The displa
35. rs Electronic device Dispose of unit and batteries properly Use by Expiration Date Lot number For In vitro diagnostic use Storage temperature range Manufacturer Single Use Only Do Not Reuse This product meets the provisions of Council Directive 98 79 EC for In Vitro Diagnostic Devices a ROE SG e oe CoaguSense Inc Authorized European Representative For In Vitro Diagnostic Use Page 17 Coag Sense Prothrombin Time PT INR Monitoring System Professional User s Manual Directions for Use Note The Coag Sense PT INR system is packaged in a special box Do not discard this box Re use the package to transport the meter or if directed by Customer Service to return it for testing 6 Operating Conditions To ensure that your Coag Sense PT INR system is working correctly be sure the following conditions are met Page 18 Be sure that the meter and strip are at room temperature before use Room temperature is between 65 F and 90 F 18 C and 32 C 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 Avoid dropping the meter or treating it roughly Use the meter only on a level stable surface Do not move or touch the meter during testing Do not place the meter in direct sunlight or high intensity light For In Vitro Diagnostic Use CoaguS
36. sional User s Manual Meter Page 14 obtain a new strip repeat the fingerstick ona different finger and test again If you need to repeat a test use a different finger for the fingerstick since blood may have started to clot on the first finger which may cause unreliable results If there is a bubble or an air pocket showing in the blood sample in the collection tube start the test over Use a new fingerstick using a different finger and collection tube or results may be unreliable Refer to the package inserts provided with the Lancets and Sample Transfer Tubes for more information If using batteries use only AA 1 5 V alkaline batteries in the Coag Sense meter Rechargeable batteries cannot be used as they may damage the meter Use only the included Coag Sense AC adapter with the meter or damage to the meter may result 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 Coag Sense PT INR meter Do not move or touch the meter while it is running a test Unreliable results may occur For In Vitro Diagnostic Use CoaguSense Inc
37. toring 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 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 The device is not intended to be used for screening purposes The Coag Sense PT INR System may be used for multiple patient testing in a professional healthcare setting Anticoagulation Medication Oral anticoagulation medications also known as blood thinners 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 Oral anti coagulation medication is prescribed to patients with acute and chronic conditions including but not limited to congestive heart failure atrial fibrillation prosthetic heart valve myocardial infarction joint replacement deep vein thrombosis pulmonary embolism thrombotic stroke coronary artery disease venous thromboembolism and cancer Blood clotting Time The rate at which blood clots is measured in units is called International Normalized Ratio INR It is very important for patients to stay within their individual target INR range If the INR Page 4 For In Vitro Diagnostic Use CoaguSense Inc Conta
38. ts memory When the 100th result is reached the first result 1 is replaced written over with test results for test number 101 This continues with the oldest result being replaced with the most recent Memory is not lost if there is a break in power for any length of time Memory cannot be erased Action The memory can be accessed from any mode that displays a MEM button 1 Press MEM The meter displays the last two records 2 Press PREV or NEXT to scroll through the result records 3 Press DONE when finished CoaguSense Inc For In Vitro Diagnostic Use Meter Display Example of display with two most recent records 2 07 13 INR 5 2 12 56 PM PT 49 1 2 06 13 12 56 PM PT 28 8 INR 2 9 DONE i NEXT PREV Note a If any messages are displayed such as NO CLOT DETECTED or CLOT TIME TOO LONG refer to the Troubleshooting section of this manual Page 37 Coag Sense Prothrombin Time PT INR Monitoring System Professional User s Manual With the optional portable printer and cable 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 What you ll need e Coag Sense meter running software version 3 87 or greater e Citizen Pocket Printer PD 22 thermal portable printer e Citizen RS232C Cable Model Ca N PD79901 Sxl RC 2s e Serial Cable Null Modem Adapter RS 232C Cable 9 pin D sub
39. y looks like this WARMING It shows a countdown of PLEASE WAIT the time remaining during 21 the warm up cycle Note Do not apply the control activation solution until Warming count the warm up is down in seconds complete and the meter tells you to do so 6 The meter beeps once when APPLY it is ready for the control strip CONTROL activation solution The SOLUTION screen looks like this Note You now have 2 5 minutes to apply the activation solution to the control strip 7 Open the control activation solution and hold at an angle to allow insertion of the transfer tube hy 8 Holding the transfer tube P below bulb insert into control activation solution Notes DO NOT SQEEZE THE BULB Be careful to avoid getting bubbles in the transfer tube CoaguSense Inc For In Vitro Diagnostic Use Page 23 Coag Sense Prothrombin Time PT INR Monitoring System Professional User s Manual Action Meter Display 9 Rest hand on instrument to a steady Move fingers to flat sides of bulb being sure to g cover air hole Insert tip into sample application well of il D gt test strip touching tip down on strip at flashing green A light Squeeze bulb until solution leaves tube 10 When the control activation TESTING PLEASE WAIT solution is properly applied and detected the flashing green light will turn off and the meter display looks like this Note If this screen is not displayed eith
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