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CoaguSense Coag-Sense Prothrombin Time PT/INR Self-Test User's Manual

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Coag-Sense
Prothrombin Time (PT)/INR
Monitoring System
Self-Test User's Manual

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

  • Page 1 ® Coag-Sense Prothrombin Time (PT)/INR Monitoring System Self-Test User’s Manual...
  • Page 2 CoaguSense. Coag-Sense is a registered trademark of CoaguSense, Inc.

  • Page 3: Contacting Coagusense

    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...

  • Page 4: Table Of Contents

    ® Prothrombin Time (PT)/INR Monitoring System Self-Test User’s Manual Coag-Sense Table of Contents Contacting CoaguSense ..............3 Table of Contents ................. 4 About This Manual ..............5 System Description ..............6 Reordering Information ............10 Warnings and Precautions ............10 Hazards and Symbols ..............

  • Page 5: About This Manual

    Technical Support (USA) at 1-866-903-0890. Note ◙: Notes provide additional information that is useful or important. All notes are italicized. Words in BOLD ALL- CAPITALS refer to buttons on the Coag-Sense meter. CoaguSense, Inc. For In Vitro Diagnostic Use Page 5...

  • Page 6: System Description

    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 system of self-checks. Page 6 For In Vitro Diagnostic Use CoaguSense, Inc.
  • Page 7  2 High Control Strips  1 Control Strip Activation Solution  Gauze or cotton balls  Lancets, 21 gauge An optional AC Power Adapter can be ordered (catalog number 03P64-01). CoaguSense, Inc. For In Vitro Diagnostic Use Page 7...
  • Page 8 Prothrombin Time (PT)/INR Monitoring System Self-Test User’s Manual Coag-Sense The Coag-Sense Meter: Top View Meter Display Menu Buttons Power On/Off Button Strip Holder The Coag-Sense Meter: Bottom View Battery Door Battery Door Release Page 8 For In Vitro Diagnostic Use CoaguSense, Inc.
  • Page 9 Jack Data/Printer Port The Coag-Sense Test Strip Mixing Wheel and Reaction Well Sample Application Area Bar Code Handle (Green light flashing (Faces down when when ready for sample) inserted into meter) CoaguSense, Inc. For In Vitro Diagnostic Use Page 9...

  • Page 10: Reordering Information

    Test Site and Blood Sample  The quality of the blood sample can become the weakest link in any PT test. A blood sample of poor quality can produce results of poor quality. Read the Page 10 For In Vitro Diagnostic Use CoaguSense, Inc.
  • Page 11  If a test requires a repeat, use a different finger for the fingerstick, since blood may have started to clot on the first finger, which may cause unreliable results. CoaguSense, Inc. For In Vitro Diagnostic Use Page 11...
  • Page 12 Store and use the Coag-Sense PT/INR Test System following the instructions in this manual.  Use only the optional Coag-Sense AC power adapter with the meter or damage to the meter may result. Page 12 For In Vitro Diagnostic Use CoaguSense, Inc.
  • Page 13  DO NOT OPEN THE METER. Do not attempt to repair or modify this meter. The Coag-Sense Self-Test PT Meter does not require any periodic maintenance CoaguSense, Inc. For In Vitro Diagnostic Use Page 13...
  • Page 14 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. Page 14 For In Vitro Diagnostic Use CoaguSense, Inc.

  • Page 15: Hazards And Symbols

    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 CoaguSense, Inc. For In Vitro Diagnostic Use Page 15...

  • Page 16: Directions For Use

    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. Page 16 For In Vitro Diagnostic Use CoaguSense, Inc.

  • Page 17: Power On And Off

    The blinking characters may be changed by Press NEXT to advance pressing + to increase or to next character. – to decrease. When correct, press NEXT to advance to the next character. CoaguSense, Inc. For In Vitro Diagnostic Use Page 17...
  • Page 18 DONE DONE NEXT when finished. Press DONE when date and time are correct Note ◙: The clock time does not adjust for daylight savings time. Page 18 For In Vitro Diagnostic Use CoaguSense, Inc.

  • Page 19: Performing A Control Test

    WARNING: Do not move or touch the meter while it is running a test. Unreliable results may occur. Note ◙: If an error message appears, consult the “Troubleshooting” section of this manual. CoaguSense, Inc. For In Vitro Diagnostic Use Page 19...
  • Page 20 The strip fits snuggly when pushed all the way toward the back wall of the strip holder. When the strip is correctly inserted, the display looks LOW CONTROL like this. DETECTED Note ◙: If anything other than Page 20 For In Vitro Diagnostic Use CoaguSense, Inc.
  • Page 21 Holding the transfer tube below bulb insert into control activation solution. Note ◙: DO NOT SQEEZE THE BULB. Be careful to avoid getting CoaguSense, Inc. For In Vitro Diagnostic Use Page 21...
  • Page 22 11. When the low control testing LO CONTL OK is complete, the display PT 12.8 shows “OK” and looks 12/18/13 4:01 PM similar to this. REMOVE STRIP Page 22 For In Vitro Diagnostic Use CoaguSense, Inc.
  • Page 23 (SHARPS) container. You can now proceed to test your blood. If you are not going to test, turn off the meter by pressing the POWER button. CoaguSense, Inc. For In Vitro Diagnostic Use Page 23...

  • Page 24: Performing A Pt Test

    Holding the round end, gently push the strip completely into the meter in one smooth motion. The strip fits snuggly when pushed all the way toward the back wall of the strip holder. Page 24 For In Vitro Diagnostic Use CoaguSense, Inc.
  • Page 25 When the warm-up APPLY completes, the meter SAMPLE beeps once. The screen looks like this. Note ◙: You now have 2 ½ minutes to apply the sample to the test strip. CoaguSense, Inc. For In Vitro Diagnostic Use Page 25...
  • Page 26 Note ◙: If this screen is not displayed, either not enough blood sample was applied or the sample had bubbles in it. Remove the strip and retest with a new strip. Page 26 For In Vitro Diagnostic Use CoaguSense, Inc.
  • Page 27 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.
  • Page 28 Follow instructions for re-testing on the Coag-Sense PT/INR meter. For unexpected results, contact Technical support at 1-866-903-0890. Always follow your doctor’s instructions for adjusting your dose of anticoagulant medication, or any other corrective actions. Page 28 For In Vitro Diagnostic Use CoaguSense, Inc.

  • Page 29: Collecting A Fingerstick Sample

     Gently squeeze or massage the finger to be lanced, near the tip. Good circulation can be seen if your fingertip changes to a pinkish shade. CoaguSense, Inc. For In Vitro Diagnostic Use Page 29...
  • Page 30 (within 15 seconds), repeat with a fresh fingerstick and a new strip.  There are no bubbles or air pockets in the tube or sample. Page 30 For In Vitro Diagnostic Use CoaguSense, Inc.
  • Page 31 Hold the finger tightly between your thumb and index finger, or place hand on a table with the palm facing up. Keep your fingertip from touching anything so that it remains clean and ready. CoaguSense, Inc. For In Vitro Diagnostic Use Page 31...
  • Page 32 WARNING: Squeezing the fingerstick site excessively (milking) releases “tissue layer” fluid that can cause unreliable results. Page 32 For In Vitro Diagnostic Use CoaguSense, Inc.
  • Page 33 11. Throw the lancet and the Note ◙: The minimum amount strip into a biohazard must be collected before container. adding it to the test strip. Never add more blood to the test strip. CoaguSense, Inc. For In Vitro Diagnostic Use Page 33...

  • Page 34: Reviewing The Memory

    PREV 3. Press DONE when finished. Note ◙: If any messages are displayed, such as CLOT TIME TOO SHORT, or NO CLOT DETECTED refer to the “Troubleshooting” section of this manual. Page 34 For In Vitro Diagnostic Use CoaguSense, Inc.

  • Page 35: Control Strips

    The AA 1.5 V batteries can last for approximately 300 tests if the meter is operating only on batteries. The batteries can last CoaguSense, Inc. For In Vitro Diagnostic Use Page 35...
  • Page 36 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 release. Page 36 For In Vitro Diagnostic Use CoaguSense, Inc.
  • Page 37 4 new standard 1.5V AA alkaline batteries. (The proper direction for battery placement is shown on a figure inside the battery compartment). Replace the battery door. Properly dispose of old batteries. CoaguSense, Inc. For In Vitro Diagnostic Use Page 37...

  • Page 38: Cleaning The Meter

    WARNING: Do not allow any liquids to spill on the meter. If this should occur, unplug the meter (if plugged in) and call Tech Support. Page 38 For In Vitro Diagnostic Use CoaguSense, Inc.

  • Page 39: Troubleshooting

    “Apply Sample” DETECTED is applied on the strip message. but outside of the  Ensure that the sample application pipette tip/transfer well. tube touches the sample well before dispensing sample. CoaguSense, Inc. For In Vitro Diagnostic Use Page 39...
  • Page 40 CLOT TIME TOO SHORT Gently squeeze the transfer tube bulb until the blood exits being sure not to introduce air bubbles. If the same message repeats, contact Technical Support. Page 40 For In Vitro Diagnostic Use CoaguSense, Inc.
  • Page 41 The lot of strips has Use a different lot of expired. strips that has not TEST STRIP expired. EXPIRED SEE Date is incorrect. MANUAL Verify the date setting on the meter is current. CoaguSense, Inc. For In Vitro Diagnostic Use Page 41...
  • Page 42 If on the strip or with the PROBLEM display persists try meter again with another strip. A used strip was If the message displays inserted. again, contact Tech Support. Page 42 For In Vitro Diagnostic Use CoaguSense, Inc.
  • Page 43 35ºC) and allow meter time to adjust to correct temperature. Repeat testing. HEATER PROBLEM Turn meter off then on again. Try again with another strip. If the display persists contact Tech Support. CoaguSense, Inc. For In Vitro Diagnostic Use Page 43...
  • Page 44 If the message persists contact Technical Support. There may be a Try again with another problem with the strip strip or contact Tech MOTOR or with the meter. Support. PROBLEM Page 44 For In Vitro Diagnostic Use CoaguSense, Inc.
  • Page 45 BATTERY tests. However, the batteries should be replaced as soon as possible. BATTERY TOO The meter batteries Replace batteries to must be replaced. continue with testing. CoaguSense, Inc. For In Vitro Diagnostic Use Page 45...

  • Page 46: Performance Characteristics

    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 46 For In Vitro Diagnostic Use CoaguSense, Inc.

  • Page 47: Meter Specifications

    Equipment Classification Class II with external power supply. Internally powered when operated with batteries. IPXO rating. WARNING: Use only the Coag-Sense AC power adapter or damage to the meter may result. CoaguSense, Inc. For In Vitro Diagnostic Use Page 47...

  • Page 48: Warranty

    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.
  • Page 49 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”...

  • Page 50: Index

    Performing a Patient Test, 25 Prothrombin Time, 3 PT, 3, 28 Date, 18, 19, 28, 35, 36, 37 PT Test Strip Package, 25 Detect Problem, 45 Remove Strip, 40 E-Mail Support, 3, 54 Page 50 For In Vitro Diagnostic Use CoaguSense, Inc.
  • Page 51 Room Temp Incorrect, 43 Troubleshooting, 40 Squeezing the Fingerstick Site, Unexpected Results, 29 System Description, 6 Warnings and Precautions, 10 Warranty, 49 Test Strip, 9 Wheel Problem, 43, 44 CoaguSense, Inc. For In Vitro Diagnostic Use Page 51...
  • Page 52 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. 48377 Fremont Blvd, STE 113 EMERGO EUROPE Fremont, CA 94538 USA Molenstraat 15 Tel: (510) 270-5442 2513 BH, The Hague Fax: (510-226-6540 The Netherlands Product Made in U.S.A...

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