CoaguSense Coag-Sense Prothrombin Time PT/INR Self-Test User'S Manual Download Page 1

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Coag-Sense

Prothrombin Time (PT)/INR

Monitoring System

Self-

Test User’s Manual

Summary of Contents for Coag-Sense Prothrombin Time PT/INR

Page 1: ...Coag Sense Prothrombin Time PT INR Monitoring System Self Test User s Manual ...

Page 2: ...ts 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 3: ...king with your doctor or health care professional Contacting CoaguSense If you have any questions or concerns with the Coag Sense 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 WARNING Contact your health care provider if you have any questions about your test results and an...

Page 4: ...azards and Symbols 15 Directions for Use 16 6 Operating Conditions 16 7 Power On and Off 17 8 Setting the Time and Date 17 9 Performing a Control Test 19 10 Performing a PT Test 24 11 Collecting a Fingerstick Sample 29 Sample Collection and Transfer Methods Error Bookmark not defined 12 Reviewing the Memory 34 13 Control Strips 35 14 Replacing the Batteries 35 15 Cleaning the Meter 38 16 Troublesh...

Page 5: ...stem and practice the test with a health care provider before attempting to use this device The Coag Sense system should only be used with a doctor s prescription This User Manual has different formats and symbols to distinguish warnings notes and meter buttons WARNING This indicates a warning or precaution Please read and understand all warnings and precautions They tell you about potential safet...

Page 6: ...ction of this manual or contact Tech 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 ...

Page 7: ...lf Test Quick Reference Guide Sample Transfer Tubes Sample package of Single use Auto Sterile Lancets Four AA 1 5 V Alkaline Batteries not installed You will also need Coag Sense Test Strip catalog number 03P56 50 which includes 50 Patient Test Strips 2 Low Control Strips 2 High Control Strips 1 Control Strip Activation Solution Gauze or cotton balls Lancets 21 gauge An optional AC Power Adapter c...

Page 8: ...ring System Self Test User s Manual Page 8 For In Vitro Diagnostic Use CoaguSense Inc The Coag Sense Meter Top View The Coag Sense Meter Bottom View Meter Display Power On Off Button Menu Buttons Strip Holder Battery Door Battery Door Release ...

Page 9: ...tic Use Page 9 The Coag Sense Meter Rear View The Coag Sense Test Strip AC Adapter Jack Data Printer Port Handle Mixing Wheel and Reaction Well Bar Code Faces down when inserted into meter Sample Application Area Green light flashing when ready for sample ...

Page 10: ...ns General Patients taking Warfarin Coumadin and other oral blood thinners should consult with their healthcare provider before adjusting their dosage Patients should consult with their doctor for the appropriate INR therapeutic range for them Patients who have recently taken or are currently taking any type of Heparin or Low Molecular Weight Heparin anticoagulant should not use this test system a...

Page 11: ...issue layer fluid and tissue factors that can cause unreliable results The fingerstick site should 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 If Alcohol 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...

Page 12: ...e damage to the meter may result Do not throw used batteries in the trash Dispose of properly 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 Tech Support Do not allow any liquids to spill on the meter If this should occur call Tech Support Do not put the meter in liquid Do not allow liquids to...

Page 13: ... 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...

Page 14: ...t Strips Control Strips Control Strip Activating Solution The test strips are designed for single use only Do not reuse the test strips Discard used strips in a puncture resistant biohazard waste SHARPS container 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...

Page 15: ...ipment 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 containers 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 ...

Page 16: ...ox 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 System is working correctly be sure the following conditions are met Be sure that the meter and strip are at room temperature before use Room temperature is between 65ºF and 90ºF 18ºC and 32ºC Relative humidity should be between 10 and 85 wi...

Page 17: ...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 Meter Display 1 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 2 The blinking characters may be changed by pressing to inc...

Page 18: ...d to change the date or time in the future press SET The meter display shows the set time and date 6 Adjust the time and date by pressing to increase or to decrease When the time and date are correct press DONE when finished Note The clock time does not adjust for daylight savings time Press DONE when date and time are correct 8 00AM 3 07 13 DONE NEXT Press SET to adjust date and time again if nec...

Page 19: ...ips 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 o...

Page 20: ...t 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 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 Note...

Page 21: ...is complete and the meter tells you to do so 6 The meter beeps once when it is ready for the control strip activation solution The screen looks like this Note You now have 2 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 8 Holding the transfer tube below bulb insert into control activ...

Page 22: ...aves tube Note Keep pressure on bulb and pull away from strip avoids back suction 10 When the control strip activation 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 either not enough solution was applied or the solution had bubbles in it Remove the strip Retest with a new control strip Do ...

Page 23: ... only The date and time shown after actual testing is the current date and time Note Remember to repeat this entire procedure with a high control strip 12 When high control testing is complete the display shows OK and looks similar to this Note If an error message appears refer to the Troubleshooting section 13 Once the controls have been successfully tested remember to throw the control strips in...

Page 24: ...play 1 Make sure that the meter is on by pressing the POWER button on the top of the meter Note If an 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 in one smooth m...

Page 25: ... warm up cycle Note Do not apply any test sample until the warm up completes and the meter tells you do so While the meter is warming up get ready to perform a fingerstick See Collecting a Fingerstick Sample in this manual 6 When the warm up completes the meter beeps once The screen looks like this Note You now have 2 minutes to apply the sample to the test strip PAT STRIP DETECTED SET MEM OFF APP...

Page 26: ...ch 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 display looks like this Note If this screen is not disp...

Page 27: ...s Then remove the test strip Throw it away in the biohazard container Note Repeat the test if the results seem unusually low or high If the results still seem unusual after a second test contact your doctor or CoaguSense Tech 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 ...

Page 28: ...et lifestyle or taking nutritional supplements such as ginkgo biloba can affect the action of oral blood thinners and the INR value 3 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 your doctor is aware of any of these conditions before yo...

Page 29: ...getting good access to the blood Thoroughly clean your hands by washing with soap and warm water first The warm water also helps blood circulation Completely dry your hands Instead you may use Isopropyl alcohol wipes and then dry the area with gauze For better blood flow keep your hand below your heart One of the middle or index fingers on either hand is recommended Gently squeeze or massage the f...

Page 30: ...es before doing the fingerstick 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 the Lancet device instructions for more information on use Lance the fleshy part of the fingertip just slightly left or right of the center Press lancet firmly against finger Refer to the package inserts for the Lancet devi...

Page 31: ... any calluses or scars 3 If desired 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 Note Residual alcohol will affect results Be certain that finger is completely dry 5 Hold the finger tightly between your thumb and index finger or place hand on a table with the palm faci...

Page 32: ...in Holding the body of the lancet push down firmly against the finger to lance the surface of skin Note The blood should flow freely If it doesn t gently squeeze the finger to get it started Lowering your hand and arm to your lap so that the fingertip is below the heart helps the blood drop form WARNING Squeezing the fingerstick site excessively milking releases tissue layer fluid that can cause u...

Page 33: ...letely fill capillary 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 10 Apply gauze to your fingerstick site with firm pressure until the bleeding stops Apply a bandage if desired 11 Throw the lancet and the strip into a biohazard container WARNING If there is a bubble or an air pocket s...

Page 34: ...ced 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 Meter Display The memory can be accessed from any mode that displays a MEM button 1 Press MEM The meter displays the last two records Press PREV or NEXT to scroll through the result records 3 Press DONE when finished Note If any messages are displayed such as CLOT TIME TOO...

Page 35: ...h box of test strips Additional controls may be ordered separately See Performing a Control Test in this manual 14 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 go back to the factory settings...

Page 36: ...ower 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 ti...

Page 37: ...stic Use Page 37 3 Remove the old batteries and replace with 4 new standard 1 5V AA alkaline batteries The proper direction for battery placement is shown on a figure inside the battery compartment 4 Replace the battery door 5 Properly dispose of old batteries ...

Page 38: ...abrasive cloth If required a mild disinfectant such as a 10 bleach solution or 70 isopropyl alcohol may be used Apply the cleaning solution to the cloth to dampen Then put cloth on the meter Alcohol prep pads may also be used WARNING Do not put the meter in liquid Do not allow liquids to get into any of the connectors or plugs on the meter WARNING Do not allow any liquids to spill on the meter If ...

Page 39: ...OVE STRIP Meter turned off with used strip in it If no strip present possible shipment damage Remove the strip and begin again Call Tech Support 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 Repeat th...

Page 40: ...ry short and out of testing range 8 seconds An air bubble was detected in the sample Repeat the entire procedure including fingerstick on a different finger with a new strip Visually confirm that no air bubbles are in the sample before applying to test strip Gently squeeze the transfer tube bulb until the blood exits being sure not to introduce air bubbles If the same message repeats contact Techn...

Page 41: ...the transfer tube before removing tip from the test strip well Visually confirm that no air bubbles are in the sample and that the glass portion of the transfer tube is full before applying to test strip Release pressure on the transfer tube bulb only after removing transfer tube from sample application well Repeat the entire procedure including fingerstick with a new strip If the same message dis...

Page 42: ...immediately upon receipt of your shipment of new test strips as they have a limited shelf life ROOM TEMP INCORRECT SEE MANUAL The temperature of the room is either below or above the operating temperature range of the meter Move the meter to a place that is within the operating temperature range of the meter 55ºF to 95ºF 13ºC to 35ºC and allow meter time to adjust to correct temperature Repeat tes...

Page 43: ...g the strip completely with the other hand Insert the strip using a quick smooth motion Move the meter indoors 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 PROBLEM The meter is too warm or too cold or there may be a problem with the meter Move the meter to a place that is within the operating t...

Page 44: ...nsert the strip using a quick smooth motion Try again with another strip If the message persists contact Technical Support LIQUID PROBLEM There may be a problem with the strip or with 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 a...

Page 45: ...use Solution BATTERY LOW The meter batteries need to be replaced The meter can complete the current test as well as one or two more tests However the batteries should be replaced as soon as possible BATTERY TOO LOW The meter batteries must be replaced Replace batteries to continue with testing ...

Page 46: ...c Use CoaguSense Inc 17 Performance Characteristics Expected Values Fingerstick whole blood results are reported in units equivalent to a reference method Measuring Range INR 0 8 to 8 0 Normal Range The following example represents a common normal range for the Coag Sense System INR 0 7 to 1 2 PT 8 0 to 15 0 ...

Page 47: ...ring 100 tests with time and date Battery Quantity 4 of 1 5V AA alkaline batteries AC Input 120 VAC Use Coag Sense Adapter Only Power Output 6 0V 2 0A Blood Sample Size 10 12 µL 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 2 lb 0 5 kg Equipment Classification Class II with external power supply Internally powered when operated with batterie...

Page 48: ...at 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 CoaguSense Te...

Page 49: ...Y 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 5 bleach solution or 70 isopropyl alcohol as described in the Maintenance section The original packaging may be require...

Page 50: ...Time Too Short 41 Collecting a Fingerstick Sample 30 Control Out of Range 43 Control Strip 36 Control Strip Activation Solution 23 Customer Service 3 17 54 D Date 18 19 28 35 36 37 Detect Problem 45 E E Mail Support 3 54 Expected Values 47 H Hazards and Symbols 15 Heater Problem 44 I IEC 60601 1 15 INR 3 28 Install Batteries 36 L Lancet 33 Liquid Problem 45 Low Control Strip 20 M Measuring Range 4...

Page 51: ...tro Diagnostic Use Page 51 Room Temp Incorrect 43 S Squeezing the Fingerstick Site 33 System Description 6 T Test Strip 9 Troubleshooting 40 U Unexpected Results 29 W Warnings and Precautions 10 Warranty 49 Wheel Problem 43 44 ...

Page 52: ...ll Free 1 866 903 0890 E Mail techsupport coagusense com CoaguSense Inc 48377 Fremont Blvd STE 113 Fremont CA 94538 USA Tel 510 270 5442 Fax 510 226 6540 EMERGO EUROPE Molenstraat 15 2513 BH The Hague The Netherlands Product Made in U S A REF Part No 03P51 01 CSI P N 100219 Rev D ...

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