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1. of blood For a venous sample Disinfect venipuncture site with an alcohol wipe Allow to dry Draw sample into syringe For capillary collection only Touch the capillary tube to the drop of blood Keep the tube level and allow it to fill by capillary action Fill the capillary tube halfway Do not place finger over hole in bulb Note Blood may also be applied directly from the finger to the sample target area ol Patient Testing 10 To apply a capillary sample Place finger over hole in end of capillary bulb and gently push down on top of bulb until sample has been completely expelled onto the sample target area Avoid introducing air bubbles when applying the sample To apply a venous sample Discard the first four drops of blood from the needle then immediately place one drop of blood from syringe needle directly onto sample target area of test strip Avoid introducing air bubbles when applying the sample Monitor displays the clock icon Do not touch the test strip or add more blood The result appears in about one minute Results are stored in memory co co CU i Patient Testing 11 Remove test strip and discard according to proper infection control guidelines 12 The flashing test strip icon reappears on the display If you are finished testing turn monitor off If an up or down arrow is in front of the result2. the test result is j B re higher than or lower than the measuring range of the system Refer to the Unexpected Results section of the test strip package insert for more information or Ca on Liquid Quality Control Testing What you need e CoaguChek S monitor e Test Strips in foil pouch e Test Strip Code Chip e CoaguChek S System Controls Level 1 and 2 e Timer Place monitor on a flat surface free of vibrations and turn on Monitor displays code number Make sure it matches the code number of the test strips you are using The test strip icon flashes 1 Remove test strips and controls from the refrigerator Test strips must be out of the refrigerator for at least five minutes before use Please Note Test strips may be stored at room temperature for up to 60 days Controls may be stored at room temperature for up to 30 days 2 Remove control seal by pulling tab 3 Tap vial to settle glass capsule to bottom of vial Liquid Quality Control Testing 4 To avoid the danger of injuries it is recom mended to always wrap a cloth or gauze tightly around the vial before squeezing it Squeeze to break glass capsule DO NOT BEND vial Bending may cause glass to cut through the exterior wall of the vial The capsule must break Start a timer for two and a half minutes While timer runs immediately tap vial HARD on table top ten time
3. CoaguChek S System _ This is a CLIA waived System Quick Reference Guide Coagulation Testing with Fresh Whole Blood Read your User s Manual for additional information May not print or view at 100 All unmarked prints black Coag Swoosh prints gradients of PMS 300 on top and PMS 194 on bottom The letter S in the Coag logo prints PMS300 The word System in the Coag logo prints 50 black Roche Logo prints PMS 300 Inside front and back covers are blank Table of Contents Patent TOSUN g er ascenrseerverren vervent eenen en 3 Liquid Quality Control Testing annae 8 Changing Result Units nanne senen 12 Reviewing Memory seccececeesesseseseeseseesesessesesseeesesenseeetees 12 Patient Testing 1 What you need e CoaguChek S monitor e Test Strips in foil pouch e Test Strip Code Chip e Cotton balls or tissue D e Alcohol wipe Eae A For a capillary sample e Lancet e Capillary tube and bulb Cat No 461 REF 11621173001 optional e Lancet device optional For a venous sample e Plastic syringe anticoagulant free e Syringe needle should be 23 gauge or larger A 21 gauge or larger needle is recommended e Tourniquet Test strips must be out of the refrigerator for at least five minutes before use Keep remaining pouches in refrigerator Make sure Test Strip Code Chip number matches the first three numbers after the lot symbol on the test s
4. both the test results as well as the results stored in memory to the selected unit s You also have the option to switch from single unit display to dual unit display See the User s Manual for specific instructions on dual unit display 1 Place the monitor on a level surface and turn it on 2 When the test strip icon flashes on the display press the SET button located at the back of the monitor The monitor enters the Set mode Press the SET button until the primary unit line flashes Press the Mem button to select the primary units Press the SET button The secondary unit line flashes Press the Mem button to select the secondary units Press the SET button Turn the monitor off ONO e OS Reviewing Memory Place monitor on a flat surface and turn it on Wait for the flashing test strip icon to appear Press the Mem button The monitor stores the last 60 results in memory along with the time and date The most recent result is displayed first Use the Mem button to scroll through the monitor s memory The control test results are followed by a c Turn the monitor off 12 COAGUCHEK is a trademark of Roche The CoaguChek S system monitor and test strips and its use are covered by one or more of the following U S Patents 4 849 340 5 110 727 5 164 598 5 300 779 5 522 255 5 710 622 5 789 664 5 792 944 and 5 886 252 The CoaguChek S monitor and its use are covered by one or more of the following U S Pat
5. ents 5 053 199 5 526 111 5 792 944 5 841 023 and 5 886 252 The CoaguChek test strips are covered by U S Patent No 5 488 816 and 5 975 153 2005 Roche Diagnostics All rights reserved 12137909003 0705 Our medical professionals are ready to answer your questions 24 hours a day 7 days a week 365 days a year Call Roche Diagnostics Technical Service Center at 1 800 428 4674 Roche Diagnostics 9115 Hague Road Indianapolis IN 46256 www coaguchek com
6. s to mix contents Lay control on table for the rest of the two and a half minutes At the end of two and a half minutes turn the monitor ON When the test strip icon flashes open test strip pouch and remove test strip Liquid Quality Control Testing Liquid Quality Control Testing 9 Insert test strip The test strip 12 Discard the first drop of icon appears and the clock control solution into cap icon flashes Discard cap with drop 13 Apply the second drop of control solution to test strip Avoid introducing air bubbles into the sample A hanging drop must be formed on the m bottle tip before applying the sample to the test strip 10 Once the flashing blood drop 14 Monitor beeps as it detects icon appears shake contents wer the drop of vial down to dropper end iH Li PE lle minute 4 Do not disturb test strip while should have elapsed since mm testing breaking the glass ampule Wait for result Control result followed by a c appears in the display Compare result to Control Value sheet Lc en 1 LJ se 11 With dropper end down 15 Remove test strip and dispose of control vial and test remove cap strip according to proper infection control guidelines 16 Turn monitor off if you are finished testing bake 10 11 Changing Result Units Note This procedure changes
7. trip pouch If numbers do not match see User s Manual For capillary sample Prepare lancet device Firmly insert end of capillary tube into capillary bulb to the line For venous sample Prepare a plastic syringe that sa zi is free of anticoagulant Patient Testing 4 Place monitor on a flat surface free of vibrations and turn on Monitor displays code number Make sure it matches the code number of the test strips you are using The test strip icon flashes 5 Open test strip pouch and remove the test strip It must be used within FOUR minutes of opening 6 Gently insert test strip in the direction of the arrows with printed side facing up Push test strip in until it stops Monitor displays the test strip icon The clock icon flashes Do not apply sample until the flashing blood drop icon appears 7 When the flashing blood drop Patient Testing icon appears the monitor rer begins a 180 second H Lt countdown beeping every 30 i seconds until sample is ee uea applied Sample must be applied before the countdown reaches zero En A flashing yellow light through the test strip indicates where to apply the blood x For a capillary sample Clean the finger with an alcohol wipe or use soap and warm water Dry thoroughly Perform fingerstick and gently squeeze finger to develop a hanging drop of blood Use the first drop
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