Professional User Guide
Contents
1. Reorient or relocate the receiving device Increase the separation between the equipment Connect the equipment into an outlet on a circuit different from that to which the other device s are connected Consult the manufacturer or field service technician for help o Class Il Equipment The monitor is double insulated Type BF Applied Part The monitor has conductive contact with the patient Ea Biological Risks Disposable items pose biological risks The monitor is classified as ordinary equipment EA cus UL Classification Medical Electrical Equipment With respect to electrical shock fire and mechanical hazards only in accordance with UL 60601 1 and CAN CSA 22 2 No 601 1 Class I1 Internally Powered Equipment Type BF Applied Part Continuous Operation paw aioe 0 Pili Insert Strip Apply Sample Not enough Remove Strip Setup Mode blood DO NOT add more blood i Alg Temperature Caution Memory Batteries Replace are low Batteries a ele amp x Quality Control Quality Control Target Range Target Range Target Range 1 2 Feature On Feature Off Symbols a J Fn 8 INRatio 2 Power Supply User s Guide Capillary Tubes User s Guide Monitor CD Rom Quick Reference Lancets Carrying Case Training Video Guide 16 Performance Characteristics and Product Specifications Operating Conditions2. Professional User Guide INRatio 2 Prothrombin Time PT Monitoring System m Binverness medical HemoSense life without complications Professional User Guide eu Welcome Congratulations on your purchase of the INRatio2 PT Monitoring System This guide will provide you with useful information on how to perform PT testing with the INRatio2 Table of Contents page Introduction SPL 0 2 Getting your System ready for Testing 4 3 Contacting Technical Support 5 The INRatio 2 PT Monitor 4 System Description 6 5 Precautions and Limitations 7 6 Turning the Monitor ON and OFF 8 7 Changing the Monitor Settings 10 Performing a Test 8 Performing a Test 16 9 Collecting a Fingerstick Sample 20 0 Reviewing Past Results in the Monitor Memory 22 1 Quality Control 23 Maintenance and Troubleshooting 2 Care and Cleaning of your Monitor ne 2D 3 Installing Replacing Monitor Batteries 4 Troubleshooting Error Messages 26 Helpful Reference Information 5 Hazards LCD Display Icons and Symbols 29 6 Performance Characteristics and Specifications 32 ZANATAN Y 32 8 Glossary OFTOMMS oo ccsssssusssssnsmuiaiuiuiunusunuanaieiieianans 33 9 Index 35 1 Introduction Before You Begin Before using this system to test Prothrombin Time PT read this entire User Guide and the inserts that came with the INRatio Test Strips and the Lan
3. T A Example MM DD YY format r 8 Cga i la gt VOI e C WG g J a gt Mm qty JO g 30807 rc g Ezi ih o Example 12 hour format 3 Select the desired format for displaying the date Choose between MM DD YY or DD MM YY formats The first 2 sets of digits DD MM or MM DD will be flashing on the display Use the and F buttons to switch between date formats Press the k button when you have the correct date format on the display 4 Set the year The last 2 digits of the year will begin to flash on the display Use the and buttons to change the year Press the k button when you have the correct year on the display 5 Change the month The month will be flashing on the display Use the and buttons to change the month Press the K button when you have the correct month on the display 6 Change the day The day will be flashing on the display Use the and buttons to change the day Press the K button when you have the correct day on the display 7 Select the desired format for displaying the time of day Choose between 12 hour AM PM or 24 hour formats The 2 digits next to hr will be flashing on the display Use the A and T buttons to switch between 12 hour and 24 hour time formats Press the K button when you have the correct time format on the display g JOI 200 FOG ao CBHI ab 8 C
4. 2 Getting your System ready for Testing Your INRatio 2 PT Monitoring system comes with INRatio2 PT Monitor Power Supply Professional User Guide Training Video e CD ROM of User Guides in other languages Capillary Tubes e Quick Reference Guide Carrying Case e Lancets ivity differences in reagents The INRatio2 PT NOTES e DO NOT use any other Power Supply with the INRatio2 PT Monitor or you may damage the system e The INRatio2 PT monitor can also be powered using standard AA alkaline batteries You will also need NRatio Test Strips Alcohol pads INRatio Test Strips are compatible with Gauze pads the INRatio2 PT Monitor Puncture resistant Sharps container Additional INRatio Test Strips and Lancets may be ordered through an authorized INRatio2 distributor 3 Contacting Technical Support Contact Technical Support if you have questions about using your system correctly or if you are having problems with the monitor or strips Technical Support 1 877 441 7440 toll free or 1 321 441 7200 To re order supplies contact the distributor who provided you with the INRatio 2 system kit Ratio Test Strips 0100071 12 single use test strips for use Box of 12 with the INRatio2 PT Monito Ratio2 Test Strips 0100139 48 single use test strips for use Box of 48 with the INRatio2 PT Monito Ratio2 PT Monitor Power S
5. 5 C r el st NG cl sal ef 4di 12 Set the lower limit of the target range The lower limit of the target range will be flashing and the Low Target symbol will appear on the display The LO message will also appear on your test result display whenever your result falls below the lower limit Use the g and buttons o change the lower limit Press the OK button when you have the correct lower limit on he display 13 Set the higher limit of the target range The higher limit of the target range will be flashing and the High Target symbol will appear on the display The HI message will also appear on your test result display whenever your result falls above the higher limit Use the and buttons to change the higher limit Press the k button when you have the correct higher limit on the display After setting the higher limit OK will begin flashing on the display Ifthe target range is correct press the button to store the target range in the monitor You will return to the monitor display that prompts you to insert a test strip Or if you would like to re enter a target range press the and buttons to go back to the lower limit and repeat steps 12 and 13 until the correct target range is on the monitor display Example monitor displays when test results fall outside the target range 19 INR amp ci B I g The
6. 9 Collecting a Fingerstick Sample Follow these steps to obtain a drop of blood from a finger A CAUTION It is important that you use the correct technique and a 21 or 23 gauge lancet to obtain the right type and amount of blood sample Failure to do so may cause inaccurate results If you use another type of lancing device or lancet make sure to follow the instructions that came with that device to get the correct blood sample 1 Prepare sampling supplies e Lancet Sharps or other puncture resistant Alcohol pad container Gauze 2 Increase blood flow to the fingers by e Warming the hand wash in warm water or use a heating pad hand warmer Gently massaging the finger Holding the hand below the heart 3 Identify a site on the fingertip to puncture Choose a middle finger on either hand e an area near the top of the finger to either side of center e an area away from any calluses or scars 4 Clean the puncture site Clean the selected area with 70 isopropyl alcohol or an alcohol solution Dry thoroughly with gauze 5 Puncture the fingertip Follow the instructions that came with the Lancet device to puncture the fingertip 6 Apply pressure to the fingertip Apply gentle continuous pressure until a large hanging drop of blood at least 15 uL forms Apply the hanging drop of blood to the sample well on the test strip See Performing a Test Section 8 for complete instruct
7. Temperature 50 95 F 10 35 C Humidity 15 95 without condensation Atmospheric Pressure 700 hPa 1060 hPa Memory 120 tests 60 available for on screen review Data Port RS232 Power Battery 4x AA alkaline batteries Supply Input 240 VAC Output 7 5 VDC Use only INRatio Part 0100011 USA or 0100260 outside USA Power Supply or you may damage the monitor Size 5 9 H x 2 9 W x 1 8 D 15 1x7 4x 4 6 cm Weight 9 3 oz 263 g with batteries 17 Warranty Limited Two Year Warranty Use of the INRatio 2 PT Monitoring system The INRatio2 PT monitoring system the Monitor is designed for use in monitoring patients on oral anticoagulant therapy Proper adherence to the instructions in the User Guide and package insert are critical to proper operation WARNING Failure to comply with the User Guide could lead to inaccurate results and resultant incorrect medication dosing which could result in injury or death Limited Warranty HemoSense guarantees to the original purchaser of the Monitor that the Monitor is free from material defects in material and workmanship for two years from the date of purchase This warranty does not guarantee the uninterrupted operation of the monitor HemoSense s only iability and Purchaser s only remedy under this warranty is that during the warranty period HemoSense shall replace or repair at no charge any Monitor component with defects in material or workmanship HEMOSENSE MAKES NO OTHE
8. 1 for medical standards i e IEC 60950 for data processing eq equipment Furthermore all configurations shall comply with the system standard IEC 60601 1 1 Anybody who connects additional equipment to the data port that configures a medical system is responsible that the system complies with the requirements of IEC 60601 1 1 Please contact Technical Support if you have any questions about connecting devices to the data port ZA Use only the INRatio Power Supply Part 0100011 or 0100260 damage the monitor or you may ZA IEC 60601 1 1988 A1 1991 A2 1995 Amendment 2 Sub clause 6 8 2 a EMC This equipment has been tested and found to comply with the limits for medical devices to the IEC 60601 1 2 2001 These limits are designed to provide reasonable protection against harmful interference in a typical medical installation This equipment generates uses and can radiate radio frequency energy and if not installed and used in accordance with the instructions may cause harmful interference to other devices in the vicinity However there is no guarantee that int not occur in a particular installation If this equipment erference wi does cause harmful interference to other devices which can be determined by turning the equipment off and on the user is encouraged to try to correct the interference by one or more of the following measures
9. 4 standard AA batteries Follow the direction for battery placement and ends inside the battery compartment 4 Replace the battery door NOTE Turning the monitor OFF manually when it is not being used will help conserve battery power Your settings for date time display mode and target range will be saved as long as you replace the batteries within about five hours of the Low Battery symbol first appearing on the display 14 Troubleshooting Error Messages Follow these steps to resolve m Display Screen ost problems that you might encounter bo cold below the operating range for the monitor to work properly Battery power is low Replace batteries as soon However there is still as possible enough power to perform a test Battery power is very low Replace batteries There is not enough power immediately to perform a test and the monitor will turn off after about 30 seconds Ambient temperature is too Move the monitor toa warmer location and try again in a few minutes Fi Ambient temperature is too hot above the operating range for the monitor to work properly Move the monitor to a cooler location and try again in a few minutes bio i The monitor strips and or ambient temperature is too cold below the operating range to continue with the test ake sure the monitor and strips are within the operating range of
10. Prothrombin Time PT that takes into account the different sensitivity of thromboplastins reagents used in various methods INR results are comparable across PT measurement systems In Vitro Diagnostic A diagnostic test done outside the body Interstitial fluid Fluid between cells in the body Lancet A pointed device used to make a small incision or fingerstick to collect the small drop of blood used in performing a Prothrombin Time PT test Oral Anticoagulant Any oral medication e g Coumadin used to prevent the formation of blood clots Plasma The liquid part of blood Power Jack The power port located on the top right hand side of the monitor for use with the INRatio2 power supply Prothrombin Time PT Any test that measures the clotting time of plasma The INRatio2 PT monitor measures PT time using a capillary blood sample Quality Control QC The testing done to show that the monitor is working properly and giving dependable results Reagent A substance in the test strip that mixes with the blood sample Sample Light The green light on the onitor test strip guide that is directly under he sample well of an inserted test strip This ight helps users identify where to place the ood sample on a test strip 3 o o Sample Well The round hole target on the single use test strip where the blood sample is applied Strip Code Code entered and used by
11. X XX XX In both cases the monitor The monitor will prepare for The monitor will then will automatically perform a testing for a few seconds prompt you to insert a test self test where all segments strip or to confirm the strip will appear on the display code if you inserted a test strip to turn on the monitor bo e sSsS i NOTE The Low Temperature symbol bo or High Temperature symbol i will appear on the display if the ambient temperature is outside the operating range of the monitor If you get a LO or HI message move the monitor to a location that is within the operating range and begin again You will not be able to perform a test until the ambient temperature is within the monitor s operating range With the monitor ON you can e perform a test or e enter Setup mode where you can change the monitor settings or enter Memory mode where you can review past results See the appropriate sections of this User Guide for complete information for all of these options Turning the monitor OFF NOTE If your monitor is connected to a computer or other external device 2 dashes will appear on the display This means the monitor is turned OFF but is communicating with the external device You can turn the monitor OFF whenever it is idle not in the process of performing a test by pressing and holding the k button for about two seconds EN If you are using the ex
12. cause inaccurate results Confirm the Strip code each time a test strip is i nserted rface that is free of vibrations Testing on an uneven surface or shaking may cause inaccurate results DO NOT hold the monitor in your hand while running a test he test strip immediately after collection or the blood is may cause inaccurate results Strips are for single use only DO NOT reuse them or re apply blood to them This esting error A DONOT move or touch the monitor while it is running a test Collecting a fingerstick blood sa ZA Use only fresh capillary blood for A Squeezing the fingerstick site excessively milking may release interstitial fluid into the blood sample This may cause inaccurate results A The fingerstick site must be completely dry If any alcohol remains on the finger it may cause hemolysis This may cause inaccurate results mple testing 6 Turning the Monitor ON and OFF Follow these steps to turn t NOTE The INRatio 2 PT M INRatio2 and a wall jack be Turning the monitor ON ing the mon Yo have 2 options for turn e 1 2 ress and hold the button until nsert a fresh test strip if you are ready to perform a test he monitor ON or OFF onitor comes with a Power Supply but you must plug it into the fore the monitor will turn ON itor ON he monitor turns on Min ley g INRE HIA PT OR A U Q bio Qe A EN E A ERED nd FB et
13. the INRatio2 PT monitor that corresponds to the code identified on the test strip pouch container This strip code must match each new lot of test strips for your results to be accurate Test Strip A single use test strip used to perform the Prothrombin Time PT test with the PT Monitor Thromboplastins A substance used by blood platelets and combined with calcium that converts prothrombin protein into thrombin enzyme as part of the clotting cascade Warfarin An oral medication used to prevent the formation of blood clots 19 Index listed alphabetically Batteries Capillary blood sample Change monitor setup reel units to be pe eer 12 Classification ies 30 Cleaning RI Customer service information 5 36 DE AE E ene 11 Error Messages 26 Fingerstick sample collection 21 Hazards 29 Sone e IE 4 nstalling batteries 25 ntroduction 4 Limitations AIMEEN ANCE eee 25 anual shut GOWN ccc D 10 emory 22 onitor Bottom and End Views E 7 eal onitor Top VIEW 6 OK button 6 On board controls 23 Operating conditions 32 Out of target range 13 Performance characteristics ccc 32 Performing a test 8 16 Power Supply 5 32 PreCaUtIONS eonia Principles of operation Prothrombin Time test Quality Control Reviewing the memory DOI ee eats teens Se ng the OIC crs nce tn tens K Setting the time dnsenesasm
14. the Temperature symbol g as it warms up for the test EN 17 The monitor display will prompt you to apply a blood sample when it s ready to perform a test i 5 Get a fingerstick sample See Instructions for Collecting a Fingerstick Sample Section 9 for getting the correct blood sample to perform a test 6 Apply the blood sample to the sample well on the g test strip 4 Make sure you apply the sample directly over the green light f DO NOT move the monitor or your finger as you apply the L sample la N Ifyou applied a blood sample before the monitor was ready the CAUTION symbol ZN will flash on the display Remove the test strip DO NOT add more blood to the test strip Go back to step 2 and re test with a fresh test strip r X N 7 Wait for the monitor to beep and then count down for a few seconds as it performs the test ao Bo Pa X S J Ifthe monitor does not beep and count down it means not enough blood was applied DO NOT add more blood to the test A strip Remove the test strip Then go back to step 2 and re test with a fresh test strip X The test result will appear on the monitor display along with the date and time Test results are automatically stored in the monitor memory along 22577 73g with the date and time of the test See Reviewing Past Results in the Monitor Memory Section 10 for reviewing past results Example INR mod
15. the monitor Move the monitor and strips to a warmer location then repeat he test in a few minutes with a fresh strip i The monitor strips and or ambient temperature is too hot above the operating range to continue with the test ake sure the monitor and strips are within the operating range of the monitor Move the monitor and strips to a coole ocation then repeat the est in a few minutes with a fresh strip You applied a blood sample to the test strip before the monitor warm up was Repeat the test with a fresh est strip Make sure to wait until you are prompted to LO complete or you inserteda apply a blood sample ia used test strip You did not apply enough Repeat the test with a fresh m blood to fill the sample well area test strip DO NOT add more blood to the test strip AI GF The strip code is invalid Re enter the correct code beginning with the first digit J The QC1 test result is below the control range of the monitor Repeat the test with a fresh test strip If this message continues call Technical Support for assistance A The QC1 test result is above the control range of the monitor Repeat the test with a fresh test strip If this message continues call Technical Support for assistance HI A The QC test result is below the control ra
16. the body usually obtained that is red blood cells from a fingerstick Heparin A medication taken by injection Data Port The port located on the top that is used to prevent the formation of blood left side of the monitor for computer Electrodes he part of the test strip pigment and main protein in red blood ce that generates an electrical current that is connecting to a clots by inactivating thrombin Hemoglobin The oxygen carrying S impeded by the blood sample once it mixes Hemolysis The destruction of red blood cells with coagulation reagents h leading to the release of hemoglobin from within the red blood cells into blood plasma Fingerstick A small puncture to the finger Leaving alcohol on the fingertip puncture site prior to a fingerstick may lead to hemolysis Hanging Drop A drop of blood that forms Hemolysis should be avoided because it may after a fingerstick that is large enough to hang interfere with the results of the Prothrombin from the fingertip Collecting a Time PT test hanging drop helps to ensure that an adequate sample at leas applied 15uL is being Impedance Resistance of the blood sample as it coagulates to the electrical current produced by the electrodes The INRatio 2 PT monitor measures the change in impedance in the blood sample to calculate Prothrombin Time PT International Normalized Ratio INR Standardized system of reporting
17. Ifthe codes match simply press the k button while OK is flashing on the display and proceed to Step 4 A To scroll m making ch L Cf 7 After setting the fifth digit 0K wil NL Of ZL display Ifthe code is correct press th a H 7 Press the k button to accept the fi L L digit Change each digit using the and button to accept each digit and move to the next digit ore quickly through letters and numbers while ttons down anges hold the and Wb OK code in the monitor a Or if you on the mo nitor display st digi If the codes do not match use the and buttons to change the first digit of the code which will then be flashing tand move to the next buttons then press the begin flashing on the e Ok button to store the need to correct the code press the and buttons to go back to the first digit and repeat step 3 until the correct code is Z CAUTION Always match the code on the monitor display with the strip code on the test strip pouch container Failure to do so may cause inaccurate results ITI IZE NOTE Ifyou entered an invalid strip code the CAUTION symbol hi Ww QS will flash underneath the code Re enter the correct code A beginning with the first digit which is now flashing 4 Wait for the monitor to warm up The monitor will count down for a few seconds and display
18. Low Target symbol w K will appear with your test result on the display whenever your Oe Aage result falls below t Ta Zeo Example test result below Example test result below target range INR mode target range INR QC mode ati wil fl 3l a INR HI iG oa pax ZBIT 1 result is above the your target range Example test result above Example test result above target target range INR PT mode range INR PT QC mode NOTES he lower limit 734 of your target range The High Target symbol will appear with your test result on the display whenever your upper limit of e Ifyou need to go back and correct any selections before you exit you will need to repeat all Setup steps Press the Setup button to return to the monitor display where you are prompted to insert a test strip Press the Setup button again to re enter Setup mode where you will e After you co begin by setting the date mplete all Setup steps you will return to the monitor display w entered Setup mode e Your date ti battery power batteries have c if you unplug the Power Supply To save your settings install or replace the bati needed even w hen using a Power Supply here you first me display mode and target range settings are stored in the monitor using f you are using a Power Supply and have removed the batteries or the ompletely run down you will lose y
19. QC Display QC2 Display INR or HI INR PT w a A A A a Monitor Display Example Low Example High Mode QQ Display QC2 Display INR QC or HI INR QC PT LO A Faz Aaz 220mb 133 aes Ka 133 12 Care and Cleaning of your Monitor Follow these steps to keep your monitor clean NOTE No maintenance is required other than routine cleaning sa Clean the outside of the monitor with a clean damp cloth If Al aa necessary a mild detergent or disinfectant such as a 5 bleach D solution or 70 isopropyl alcohol may be used z Clean the area around the test strip guide with a swab or pad that has been dampened with alcohol or 5 bleach solution 13 Installing Replacing Monitor Batteries Follow these steps to install replace the monitor batteries The monitor batteries should be replaced whenever the Low Battery symbol f appears with the flashing CAUTION symbol A after turning the monitor ON The batteries still have enough power to perform a test but should be replaced as soon as possible When both the Low Battery symbol dih and CAUTION symbol A are flashing on any monitor display it means the batteries A i must be replaced as soon as possible The monitor will turn OFF after about 30 seconds 1 Turn the monitor upside down so that the bottom is facing you 2 Remove the battery door by pressing down on the battery door release 3 Remove the old batteries and replace with
20. R WARRANTIES AND EXPRESSLY EXCLUDES ANY IMPLIED WARRANTY OF MERCHANTABILITY NONINFRINGEMENT OR FITNESS FOR A PARTICULAR USE h e only user serviceable parts o ith any other portion of the Mo nitor abusing fthe Monitor are the battery and the battery door Tampering he Monitor or using the Monitor in a manner 365 inconsistent with its user manual will void this warranty This warranty does not apply to any omponent that is damaged by improper storage or accident or that is subject to alteration isuse tampering or abuse Before returning any defective components you must obtain a Return Material Authorization number and return instructions from Technical Support by calling 1 877 441 7440 HEMOSENSE S ENTIRE LIABILITY IN CONNECTION WITH THE MONITOR REGARDLESS OF THE LEGAL OR EQUITABLE BASIS OF ANY CLAIM IS LIMITED TO THE PURCHASE PRICE OF THE ONITOR IN NO EVENT WILL HEMOSENSE BE LIABLE FOR ANY INCIDENTAL INDIRECT SPECIAL CONSEQUENTIAL ITOR OR ANY THIRD PARTY CLAIMS EVEN IF HEMOSENSE OR ITS DISTRIBUTORS ARE AWARE OF THE POSSIBILITY OF SUCH CLAIM OR DAMAGES AND NOTWITHSTANDING THE ESSENTIAL PURPOSE OF ANY REMEDY aE PAC Cosy AEE listed alphabetically OR PUNITIVE LOSS OR DAMAGES IN ANY WAY RELATED 10 THE Capillary Blood Blood from the smallest Hematocrit The percentage of your blood blood vessels of
21. as 11 Setup DUTION saatoin 6 SPOCMCAUOMS cases ccencecis stances 32 Strip CODE ccccssssssssssstnteienteteseve 6 Supplies Symbols Target range 3 Test strip guide Test strip diagram Therapeutic range 3 ne E E ele 1 Transporting the monitor 7 Troubleshooting 26 Turn OFF MONITOR serene 8 Units choosing display seen 12 Up Down buttons 6 WAITAMLY a cccsssssssensusesssnnvtseviseven 32 Technical Support 1 877 441 7440 toll free M Co Biosite Incorporated MDSS GmbH 9975 Summers Ridge Road Schiffgraben 41 San Diego CA 92121 30175 Hannover Germany Email service support invmed com Web www hemosense com INRatio and HemoSense are registered trademarks of the Inverness Medical group of companies 2009 Inverness Medical All rights reserved 2009 05 12 0200425 Rev C HemoSense life without complications E minverness medical
22. cet device Take special note of CAUTIONS ZA throughout this User Guide You must complete proper training on the INRatio2 PT Monitoring system before you begin using Intended Use The INRatio 2 PT Monitoring system is used for the quan bin Time PT in fresh capillary whole blood The INRatio2 PT Monitori he system itative measurement of Prothrom ng system is intended for use outside the body in vitro diagnostic use by people taking warfarin and other oral anticoagulant Test Principle blood thinning therapy who need to monitor the clotti The INRatio2 PT Monitoring System is not intended to be used for screening purposes ng time of their blood A drop of blood is applied to the test strip where it is drawn into the test area The blood mixes with reagents that start the clotting reaction As the blood clots the impedance in the sample The monitor detects the change and the the sample and reports the result on the screen there is a change in n calculates the PT for The reagents used in performing PT tests can vary substantially between testing methods This may cause differences in test results depending on the method used For this reason the International Normalized Ratio INR unit was developed The INR is a mathematical correction of the PT result that adjusts for sensi Monitoring system provides both a PT and INR result with every test
23. e result Z CAUTION Unexpected results An unexpected result may include any result that falls outside the 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 they have symptoms such as bleeding or bruising What causes unexpected results 1 A hematocrit percentage of blood that is red blood cells that is higher or lower than he validated operating range of the INRatio 2 system can cause an inaccurate result Refer the test strip package insert for more information Verification of the patient s hematocrit will help ensure the reliability of results obtained with the PT monitor 2 Lupus or antiphospholipid antibody syndrome APS may falsely prolong the INR value Testing with an APS insensitive laboratory method is recommended 3 Certain prescription drugs e g heparin Refer to the test strip package insert for more information and over the counter medications e g antibiotics can affect the action of oral anticoagulants and the INR value 4 Liver diseases congestive heart failure thyroid dysfunction and other diseases or conditions can affect the action of oral anticoagulants and the INR value 5 Changes in diet lifestyle or taking nutritional supplements such as ginkgo biloba can affect the action of oral anticoagulants and the INR value Be aware of any of these conditions before you begin testing your patients and ask the
24. esult in memory INR mode Use the and buttons to scroll forward and backward through your previous results To exit Memory mode press the button You will return to EBT the monitor display where you are prompted to insert a fresh Example test resultinmemory test strip INR mode Clearing memory The monitor memory will store up to 120 results of which t on screen review You can clear the monitor memory of all for newer results Make sure to write down previous test results if you wish to keep them before you clear the monitor memory To clear the monitor memory follow these steps 1 Press the Memory button 4 to enter Memory mode 2 Press and hold the Memory button 9 for two seconds _ NM You will see this screen to con I monitor memory e 3 Press and hold the Setup b It will take about 3 seconds fo cleared After the memory is successfu NOTE If there are not yet any results stored in the monitor memory such as when you first receive your monitor a series of dashes will appear on the display he latest 60 are available for previous test results to make room firm that you want to clear the tton Dior wo seconds to confirm that you want to clear the monitor memory the monitor memory to be ly cleared you will return to the monitor display where you first entered Memory mode 11 Quality Control Quality Control QC is an important part of PT testing QC en
25. hange the hour The hour will be flashing on the display Use the and buttons to change the hour Press the OK button when you have the correct hour on the display NOTE The test result in INR 9 Change the minutes Press the k button when The minutes will be flashing you have the correct minutes on the display Use the on the display and buttons to change the minutes 10 Select the test result display mode Use the and buttons to choose 1 of 4 different unit display modes This unit display mode controls how much information will appear along with your INR test result on the monitor display nits will appear on all of the 4 display modes N J INR Mode CJ Test results are displayed in INR INR International Normalized Ratio INR units only The INR is a 2507 A 7 49 Mathematical correction ofthe Prothrombin Time PT result INR Mode Erari MAR MOE that adjusts for differences in the reagents that are used in calculating your test results INR PT Mode ri _j ri L Test results are displayed in INR PT INR PT International Normalized Ratio INR units and Prothrombin OG nh 739 Time PT seconds INR PT Mode Example INR PT Mode a acl acz Goa pae CBT 7 INR QC Mode Example INR QC Mode a bs a ac ace Goa A Hila eof 730 INR PT QC Mode Example INR PT QC Mode INR QC Mode Test results are disp
26. ions 7 Clean and dry the puncture area after applying the sample Hold gauze over the puncture site until the bleeding stops 8 Dispose of all used materials into a sharps or other puncture proof container NOTE Used test strips gauze alcohol pads lancing device and lancets may be considered biohazardous waste in your area Be sure to follow your local regulations for proper disposal 10 Reviewing Past Results in the Monitor Memory Follow these steps to review past results that are stored in the monitor memory Whenever you successfully perform a test the result is automatically stored in the monitor memory along with the date and time of the test The monitor memory will store up to 120 results in the order in which the tests were taken beginning with your most recent result The latest 60 results are available for on screen review The monitor memory also stores PT computation errors errors that occur when not enough blood has been applied to the test strip and QC errors You may access the monitor memory after performing a test or whenever your monitor is turned on Simply press the Memory button 4 Once in Memory mode the Memory symbol Q will appear on the display as you review past results JC When you enter Memory mode your most recent result will r i CJ appear on the display Use the button to scroll to your previous INR result Q bT 7B Example test r
27. layed in E International Normalized Ratio INR units along with the Quality Control QC results that are taken every time you perform a test INR PT QC Mode Test results are displayed in nternational Normalized Ratio INR units Prothrombin Time PT seconds and the Quality Control QC results that are aken every time you perform a test Press the K button when you have the correct display mode on the display 11 Select the target range mode An INR target range may be set in your monitor to alert you whe range n test results fall outside the ZA CAUTION If results fall outside the target range the target range but are not consistent with the pati status e g they have symptoms such as bleeding or bruising follow your usual procedures for taking corrective action Or if results fall within ient s current health va a OFF modes OK If you want the target range mode when the Target Range ON symbol step 12 V Target range mode ON rc Me when the Target Range OFF symbol Use the the and buttons to switch between the Target ON and ON press the button is on the display Go to If you want the target range mode OFF press the K button is on the display You OK will return to the monitor display that prompts you to insert a test strip Skip steps 12 and 13 X Target Range mode OFF cH a0 U J
28. lugged in and call Technical Support immediately The monitor is a delicate instrument and should be handled with care Dropping or other mishandling may cause it to malfunction e The monitor should be transported in a carrying case or another secure container DO NOT store the monitor below 4 F 20 C or above 158 F 70 C Testing environment e Room temperature for testing should be between 50 F and 95 F between 10 C and 35 C e The monitor and test strip must also be at room temperature before use Relative humidity should be between 15 and 95 without condensation Atmospheric pressure should be between 700 hPa and 1060 hPa Patient health status ZN Current patient health status may affect test results and cause inaccurate results or results that are not what you expect It s important to take certain health factors into cons deration when interpreting test results and deciding on a course of action for your patients Failure to do so may lead to an incorrect interpretation of the PT monitor result h See the Performing a Test Section 8 of this Professional User Guide for more information about unexpected results Performing a test Running a test with a Test with the monitor on a level s will begin clotting Th A A A Blood sample must b A Tes may cause inaccurate e applied to results or a n incorrect strip code may
29. m to alert you if there has been any change in their health status or medications once they begin testing Oo What to do when you get an unexpected result Always follow your usual procedures for re testing on the PT monitor re testing using an alternative method adjusting the dose of anticoagulant medication or any other corrective actions 8 Turn the monitor OFF when you are finished testing To turn the monitor off press and hold the button for about two seconds Remove the used test strip when prompted and discard it in a Sharps or other puncture proof container If using batteries the monitor will turn off automatically if you leave it unattended for a few minutes If using the power supply the monitor will stay on indefinitely It is recommended that you turn the monitor OFF manually to conserve power Before turning the monitor OFF you also have the option to 1 Perform another test Remove and discard the used test strip then begin again at step 2 with a fresh test strip using a different finger for the fingerstick sample 2 Review past results in the monitor memory Press the Memory button to enter Memory mode see Reviewing Past Results in Monitor Memory in Section 10 for reviewing past results 3 Change the monitor settings Press the Setup button 4 to enter Setup mode see Changing the Monitor Settings in Section 7 for changing your monitor settings
30. nge of the monitor The QC test result is above the control range of the monitor Repeat the test with a fresh test strip If this message continues call Technical Support for assistance Repeat the test with a fresh test strip If this message continues call Technical Support for assistance There is an error in calculating Prothrombin Time PT for this test There may be a problem with the monitor and strips Repeat the test with a fresh test strip If this message continues call Technical Support for assistance Test result is above the high Repeat tet If result is still 1 target you set in the monitor above the high target follow INR Hg your standard procedure for treating patients with a CGI a 1 high INR Example shown is in INR display mode Test result is below the low target you set in the monitor Repeat test If result is still below the low target follow your standard procedure for treating patients with a low INR Example shown is in INR display mode 15 Hazards and Symbols ZA The monitor generates radio frequency RF energy If your monitor is not set up and used according to this User Guide the RF energy may interfere with other devices in the area Call Technical Support if you have any questions on RF interference st be certified according to the respective IEC ZA Any devices connected to the data port m ipment and IEC 60601
31. our settings within about two hours eries as aH 8 Performing a Test Follow these steps to perform a test Z CAUTION Always place the monitor on a flat surface that is free of vibration while you perform a test DO NOT hold the monitor in your hand Failure to do so may cause inaccurate results 1 Press and hold the button or insert a fresh test strip to turn the monitor ON Q Ge ya AN i AA ae FEE bA A The monitor will es test where all segments on the display will appear ANDEN utomatically perform a self fa f you turned the monitor on LJ by pressing the button he monitor will prompt you o insert a test strip go to XXX XX step 2 The monitor will prepare for If you turned the monitor on a test for a few seconds by inserting a fresh test strip he monitor will prompt you o confirm the strip s code go to step 3 2 Insert a test strip into the test strip guide on the monitor Remove a fresh test strip from its foil pouch Insert it into the test strip guide so that the clear end with the vertical contact bars goes in first On the blue end of the strip you should be able to read the word INRatio appearing from left to right Make sure the sample well in the strip lines up with the green light on the test strip guide 3 Match the code on the monitor display with the strip code on the test strip pouch or strip container
32. ternal power supply the monitor will stay on indefinitely 71 f7 NOTE Turning the monitor OFF manually when it is not YI I Lf being used will help conserve battery power If you are using battery power and the monitor is left idle for about 10 minutes the monitor will count down for about 10 seconds and then turn OFF Press any button to keep the monitor ample timeout when belig turned ON and return to the previous monitor display prompted to apply blood 7 Changing the Monitor Settings Follow these steps to change the date time units how you want your test results displayed and whether you want to set a target range for your results 1 Press and hold the k button to turn the monitor ON eT O INRE HI Figo U Q OY A Mha CA Mhz A EEE A EEE XXX XX The monitor will The monitor will begin The monitor will then automatically perform a self preparing for a test fora few prompt you to insert a test test where all segments will seconds Strip appear on the display NOTE You may access Setup mode whenever your monitor is turned on or after performing atest 2 Enter Setup mode Press the Setup button amp o enter Setup mode The Setup symbol will appear on the display along with the year that s currently set in the monitor NOTE When you turn on the monitor for the first time the date will be set to 01 01 2004 and the time will be set to 12 00 idid
33. test correctly and that your PT monitor and test strips are wo gt Each time a PT test is performed a Low and High control tes corresponding control result s and targets s the PT monitor If either or both controls is are out of range you will be notified on the monitor with a flashing CAUTION symbol N and a LO QC1 LO QC2 HI QC1 or Hl QC2 message f your monitor is in either the INR QC or INR QC PT di sures that you are performing the are performed automatically by splay modes you will also see the rking properly together as a system A LO or HI QC message appears when the test strips have expired or have not been stored properly and have deteriorated If you get a LO or HI QC message check to make sure your test strips have not expired that the correct strip code was entered into the monitor and confirm that the strips have been stored properly Repeat the test if you believe the strips are okay If you continue to get a LO or HI QC message make note of the information on the monitor display and call Technical Support for assistance Monitor Display Example Low Example High Mode QC1 Display QC1 Display Monitor Display Example Low Example High Mode QC1 Display QC1 Display INR QC HI INR 0C PT L0 A A Yla fal ibla A ZT 739 ZT 739 Monitor Display Example Low Example High Mode
34. upply 0100011 USA Power Supply for use with the USA NRatio2 PT Monito Ratio2 PT Monitor Power Supply 0100260 Worldwide Power supply for use with Worldwide Plugset with the INRatio2 PT Monito icroSafe Capillary Tubes 0200235 Bag of 50 disposable capillary sampling tubes Unistik 21g Single Use Lancets 9902009 Disposable single use lancets Box of 50 a 4 System Description The INRatio 2 PT Monitor Top View OK Button turns the monitor ON and OFF and accepts Stores display entries LCD Display A UP and DOWN Buttons changes information on the display and scrolls between results in the monitor memory A Memory Button puts the monitor in Memory mode D Setup Button puts the monitor in Setup mode Test Strip Guide insert test strip here to turn monitor ON for Testing Sample Light apply blood sample here after the test strip is inserted The INRatio 2 PT Monitor The Test Strip Top End and Bottom Views Electrodes Battery Door Battery Door Release YY Test Area Data Port Power Supply Jack 5 Precautions and Limitations Certain conditions limit the effectiveness of the INRatio 2 PT Monitoring system to work properly and provide accurate results Take note of these limitations and precautions Care of your INRatio2 PT monitor DO NOT allow any liquid to spill on the monitor If this should occur unplug the monitor if it is p
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