Professional User`s Guide - Drug testing supplies from CLIA waived
Contents
1. Printer Press the OK button to select 6 The PRINTER options will be displayed Press the UP DOWN button to choose an option NO PRINTER iw Press the OK button to select PRINTER u 36 change set up choosing the printer option Change SetUp Choosing the Printer Option continued Action Meter Display 7 Pressthe MENU button to return to the Change Setup M enu 8 Pressthe MENU button to return to the M ain M enu 9 If you wish to perform a test at this time highlight RUN TEST in the menu by pressing the UP DOWN button Press the OK button to select T o shut down the meter highlight TURN METER OFF by pressing the UP DOWN button Press the OK button to select 37 change set up choosing the print er option cont inued Change SetUp Choosing the Language Action Meter Display 1 Press any button to turn on the meter T he meter will begin a self test PERFORMING SELF TEST 2 T he meter will prompt for a new test strip VERSION IE 3 Press the MENU button to view the M ain Menu 4 Press the UP DOWN button to highlight CHANGE SET UP Press the OK button to select 5 Press the UP DOWN button to highlight LANGUAGE Press the OK button to select 6 T he Language options will be displayed Press the UP DOWN button to choose a language Press the OK button to select 38 change set up choosing the language Change SetUp Choosing the Language continued Action M2. T he sample was applied to the test strip before the warm up was complete or a used test strip was inserted Begin again with a new test strip Be sure to wait until the Add Sample message displays T here was not enough sample applied to the test strip to fill the test area Begin again with a new test strip and perform another fingerstick DO NOT TRY TO ADD MORE BLOOD TOTHE TEST STRIP T he strip code entered was detected to be invalid by the error checking mechanism of the meter Re enter the correct strip code at the prompt If the error message repeats call HemoSense T echnical Support T he error number can be any combination of numerical digits T here was a problem with the test or not enough sample was applied to the test strip Repeat the test If the error message repeats call H emoSense T echnical Support 46 troubleshooting DATE Error Screen REMOVE OLD STRIP INR lt 0 7 ac OK INR gt 7 5 QC OK ERROR TOO COLD ERROR TOO HOT TIME TIME Action to Take T he meter was turned on with anew or used test strip in it or atest strip was left in the meter Begin test again with a new test strip If the error message recurs call H emoSense T echnical Support T he test result is outside the measuring range of the meter R epeat test If the message repeats arrange for testing by another method as soon as possible as the IN R may be dangerously out of range Ambient temperature is
3. 7 5 or lt 0 DATE TIME If this should occur repeat test INR gt 7 5 If it occurs again testing should be done by another method ac OK 16 performing atest continued Action Meter Display 15 T o begin another test insert a new test strip into the strip guide and follow the instructions beginning at step 3 INSERT STRIP If left unattended the meter will turn off automatically after a few minutes It will beep a warning and display this message Press any button if you do not wish it to turn off and it will remain activated 16 T o shut down when testing is completed Press the MENU button to return to the M ain M enu Highlight TURN METER OFF by pressing the UP DOWN button Press the OK button to select Fa NOTE Manual shutdown is recommended when meter is on battery power 17 performing atest cont inued IV Collecting a Fingerstick Sample Follow these steps to obtain a drop of blood from a fingerstick 1 Increase blood circulation by W arming the hand by washing in warm water W arming the hand with a heating pad or hand warmer Gently massaging the finger H olding the hand below the heart 2 Prepare supplies for use Lancet Alcohol pad Gauze or cotton ball e Adhesive Bandage Puncture resistant container Sharps 18 collecting afingerst ick sample IV Collecting a Fingerstick Sample continued 3 Identify a site on the finger to puncture 4 Clean the s
4. N IT S Pressthe OK button to select 6 TheUNIT S options will be displayed Press the UP DOWN button to choose an option Pressthe OK button to select 7 Pressthe MENU button to return to the C hange Setup M enu 8 Pressthe MENU button to return to the M ain M enu 9 If you wish to perform a test at this time highlight RUN TEST in the menu by pressing the UP DOWN button Press the OK button to select T o shut down the meter highlight TURN METER OFF by pressing the UP DOWN button Pressthe OK button to select 32 change set up choosing the units to be displayed continued Using the Target Range Feature Action Meter Display 1 Press any button to turn on the meter PERFORMING T he meter will begin a self test SELF TEST VERSION ee INSERT STRIP 2 T he meter will prompt for a new test strip Far NOTE If an error message appears consult the troubleshooting section 3 Pressthe MENU button to view the M ain M enu 4 Pressthe UP DOWN button to highlight CHANGE SET UP Press the OK button to select 33 using thetarget rangefeature Using the Target Range Feature continued Action Meter Display 5 Pressthe UP DOWN button to highlight TARGET Press the OK button to select 6 T heT arget Range options will be displayed Press the UP DOWN button to choose an option Press the OK button to select 7 To set acustom range highlight CUSTOM and press the OK bu
5. hour clock was selected the AM PM indicator will now be highlighted Press the UP DOWN button to toggle between AM and PM W hen correct press the OK button to select 10 Pressthe MENU button to return to the Change Setup M enu 11 Press the MENU button to return to the M ain Menu Meter Display 29 change set up setting thet ime continued Change SetUp Setting the Time continued Action Meter Display 12 If you wish to perform atest at this time highlight RUN TEST in the menu by pressing the UP DOWN button Press the OK button to select T o shut down the meter highlight TURN METER OFF by pressing the UP DOWN button Press the OK button to select 30 change set up setting thet ime continued Change SetUp Choosing the Units to be Displayed Action Meter Display 1 Press any button to turn on the meter T he meter will begin a self test PERFORMING SELF TEST VERSIONE 2 T he meter will prompt for a new test strip Far NOTE If an error message appears consult the troubleshooting section STRIP 3 Pressthe MENU button to view the M ain M enu 4 Pressthe UP DOWN button to highlight CHANGE SET UP Press the OK button to select 31 change set up choosing the units to be displayed Change SetUp Choosing the Units to be Displayed continued Action Meter Display 5 T he SetU p M enu appears on the display Press the UP DOWN button to highlight U
6. stored properly If you believe the strips are okay repeat the test If an error message is displayed again make note of the error message and call H emoSense T echnical Support for assistance 40 quality control Vil Operational Precautions and Limitations T he IN Ratio system is for in vitro diagnostic use only U se only fresh not anticoagulated capillary blood for testing Blood samples must be applied to the test strip immediately after collection or the blood will begin clotting causing inaccurate results e Squeezing the fingerstick site excessively milking releases interstitial fluid and may cause inaccurate results T he fingerstick site must be completely dry If any alcohol remains on the finger it may cause hemolysis which may cause inaccurate results Do not allow any liquid to spill on the meter If this should occur unplug the meter if it is plugged in and call H emoSense T echnical Support immediately T he meter is a delicate instrument and should be handled with care Dropping or other mishandling may cause it to malfunction Running atest strip with an incorrect strip code may cause erroneous results Confirm the strip code each time a test strip is inserted T he test strips are for one use only Do not reuse them Do not move or touch the meter while it is running a test Al Operational precautions and limit ations Vill Hazards and Symbols AN Attention T he meter genera
7. touch the meter during testing 5 Special requirement s ll Principles of Operation T he H emoSense IN Ratio system performs a modified version of the one stage Prothrombin T ime test and consists of a meter test strips and accessories On the disposable test strip are the sample well and test area T he blood is applied to the sample well T he test area contains the electrodes and reagents needed to perform atest Each strip performs a test on the blood sample applied as well as low and high control tests using reagents that are contained in the test strip T he meter consists of a Liquid Crystal Display LCD test strip area and three buttons T he test strip area contains the test strip guide the sample light and the cleaning door which can be lifted for easy cleaning The MENU button accesses the meter menu and memory functions The UP DOWN button is used to make changes and the OK button to select them T he test strip is inserted into the test strip guide W hen the strip reaches operating temperature a bright green light appears through the sample well on the strip indicating where the blood should be applied A drop of blood is applied to the test strip where it is drawn into the test area and mixed with reagents that cause coagulation to begin As the blood clots there is a change of the impedance in the sample which is detected by the meter T he meter monitors this change in impedance then calculates the PT and INR for t
8. IN RAT I O Professional U ser s G uide Distributed By CLIAwaived Inc San Diego CA 92130 U SA 858 481 5031 Table of Contents I Introducton aueh 1 Customer Service Information ou ccc 2 U se of the IN Ratio system u 3 Installation srir 4 Special Requirements errn 5 I Principles of Operation 6 T he IN Ratio meter Top VIEW 7 T he IN Ratio meter Bottom and End 8 IN Ratio Prothrombin T ime IN R T est Strip 9 Performance Characteristics and Specifications 10 UL Classification srr 11 IH Performins a Test u a 12 IV Collecting a Fingerstick Sample 18 V Main Menu Functions scc 21 Review MEMOIY ans 23 Change Setup Setting the Date wu 25 Change Setup Setting the T ime wuss 28 Units Choosing the U nits to be Displayed 31 T arget Using the T arget Range Feature 33 Change Setup Changing the Printer O ption 36 C hange Setup Choosing the L anguage 38 VL Qualy Eon leeren 40 VII Operational Precautions and Limitations 41 VII Hazards and Symbols ee 42 IX Service and Maintenance 43 Maintenance and Cleaning sesers 44 Installing Batteries nns 45 T OUD ISSO OTING 2 46 W arany eisen 50 Glosa yot Ter MS meari eee ea 51 i Introduction Congratulations on your purchase of the IN Ratio system from H emoSense T his guide will provide you with useful information needed to perform Prothro
9. T he Change Setup M enu allows you to set the clock and calendar as well as choose optional features T ime and D ate T he time and date are stored with test results in the memory of the meter It is important to set the correct time and date so that this feature can be used properly U nits Results can appear on the display as IN R only PT seconds and IN R or PT seconds INR and QC results T arget A target therapeutic range can be set in the meter If results are outside this range they will be displayed with an ABOVE TARGET or BELOW TARGET message You can choose pre set target ranges set a custom target range or deactivate this feature Printer If the optional printer is attached the printer option may be selected L anquage You can choose a language for the meter display from a list of multiple languages 21 main menu functions continued V Main Menu Functions continued TURN METER OFF T his allows you to turn off the meter T he meter will turn off automatically after a few minutes of inattention If you are using batteries shutting it down immediately will help to con serve power RUN TEST T his option returns you to the testing function 22 main menu functions continued Review Memory Action Meter Display 1 Press any button to turn on the meter T he meter will begin a self test PERFORMING SELF TEST VERSIONE 2 When the self test is complete the meter will prompt for a
10. below the operating range of the meter M ove the meter to a warmer location and begin again in a few minutes Ambient temperature is above the operating range of the meter M ove the meter to a cooler location and begin again in a few minutes 47 troubleshooting continued Error Screen ERROR QC 1 2 ERROR QC 1H DATE ERROA TIME GET Ai DGT eae STRIP CODE KH Action to Take One or both of the on board controls is out of range Check expiration date and proper storage of test strips Repeat test paying careful attention to proper technique See Section VI Quality Control for more information If message repeats call H emoSense T echnical Support T he printer option has been selected and either no printer is connected to the meter or the printer is not functioning properly Recheck all the connections If the error message repeats call H emoSense T echnical Support T he printer is out of paper Insert paper into the printer and try again 48 troubleshooting continued Error Screen BATTERIES LOW REPLACE BATTERIES If you have any difficulty inserting a test strip Action to Take T he batteries are running low and should be replaced soon Y ou may continue with the present test but the battery should then be replaced as soon as possible T he batteries are dead and the meter will now be non operational until the batteries are replaced or the unit is plugged into a wall outlet 1 Op
11. ed Power supply IN Ratio T est Strips Quick Reference Guide Alcohol pads Professional U ser s Guide Gauze pads or cotton balls e Lancets e Puncture resistant container SH ARPS container T raining Video Warranty Reply Card Refer to the package insert that is supplied with each box of test strips for further information T he IN Ratio meter may be used on battery power or with the AC adapter See Section IX for instructions on installing the batteries If you choose to use the AC adaptor part 0100011 plug it into the POW ER JACK on the back of the meter and into a conventional 120v outlet See page 8 for a diagram showing the location of the power jack If you purchased a printer part 0200046 please refer to the Printer O perating Instructions included with the printer for set up and operating instructions A installation Special Requirements T o ensure that your IN Ratio system operates correctly be sure the following conditions are met Room temperature should be between 50 F and 95 F 10 C and 35 C for testing Relative humidity should be between 10 and 95 without condensation for testing T he IN Ratio meter should be transported in its original shipping container or another secure container Avoid dropping the meter or treating it roughly T he meter and test strip must be at room temperature before use e T est with the meter on a level surface Do not move or
12. elected area 5 Puncture the finger following On one of the middle fingers of with 70 isopropyl the instructions for the lancet either hand alcohol or an alcohol that you are using N ear the top of the finger on either side pad Dry thoroughly Away from any calluses or scars with cotton or gauze 19 collecting afingerst ick sample continued IV Collecting a Fingerstick Sample continued 6 Apply gentle continuous 7 Apply the hanging drop to the 8 After applying the sample pressure until a large hanging sample well on the test strip hold gauze or a cotton ball drop of blood forms over the green light over the puncture site with firm pressure until the CAUTION bleeding stops AN DO NOT APPLYSTRONG REPETITIVE PRESSURE 9 Dispose of all used materials THIS MAY DILUTE THE properly in a biohazard SAMPLE AND CAUSE sharps container INACCURATE RESULTS 20 collecting a fingerstick sample cont inued V Main Menu Functions T he M ain M enu allows you to access the test results in memory print results access the Change Setup menu turn the meter off or return to testing REVIEW MEMORY T his function allows you to access past test results which are stored with the most recent test first Results will be displayed in the units you have selected PRINT MEMORY If the optional printer is attached results from the meter memory can be printed upon completion of the test or at any time CHANGE SETUP
13. en the cleaning door and remove any obstruction 2 Check that the test strip is not bent If it is bent discard and start again with a new strip 3 If the strip still cannot be inserted call H emoSense T echnical Support 49 troubleshooting continued Warranty Use of the INRatio system T he IN Ratio meter system the M eter is designed for use in monitoring patients on oral anticoagulant therapy Proper adherence to the instructions in the U ser s M anual and package insert are critical to proper operation WARNING Failure to comply with the user manual could lead to inaccurate results and resultant incorrect medication dosing which could result in injury or death Limited Warranty H emoSense guarantees to the original purchaser of the M eter that the M eter is free from material defects in material and workmanship for one year from the date of purchase T his warranty does not guarantee the uninterrupted operation of the meter H emoSense s only liability and Purchaser s only remedy under this warranty is that during the warranty period H emoSense shall replace or repair at no charge any M eter component with defects in material or workmanship HEMOSENSE MAKESNO OTHER WARRANTIES AND EXPRESSLY EXCLUDES ANY IMPLIED WARRANTY OF MERCHANT ABILITY NONINFRINGEMENT OR FITNESS FOR A PARTICULAR USE T he only user serviceable parts of the M eter are the battery the cleaning door and the battery door T ampering with any other portion o
14. eter Display 7 Pressthe MENU button to return to the Change Setup M enu 8 Pressthe MENU button to return to the M ain M enu 9 If you wish to perform a test at this time highlight RUN TEST in the menu by pressing the UP DOWN button Press the OK button to select T o shut down the meter highlight TURN METER OFF by pressing the UP DOWN button Press the OK button to select 39 change set up choosing the language continued VI Quality Control Quality control is an important part of PT testing T esting controls ensures that you are performing the steps of the test correctly and that your IN Ratio system is working properly Each time a test is performed alow and high control are tested automatically by the IN Ratio system When aQC OK message appears or QC 1 and QC2 results are displayed without an error message the meter is working properly the test strip is working properly and testing was done using acceptable techniques If the control result is out of range an error message indicating which controls are not in range will appear on the display If the INR PT QC feature is selected the actual QC results for each test will be displayed An error message usually occurs when test strips have not been stored properly and have deteriorated If you get a control error message check to make sure your test strips have not expired that the correct strip code is input into the meter and confirm that they have been
15. f the M eter abusing the M eter or using the M eter in a manner inconsistent with its user manual will void this warranty T his warranty does not apply to any component that is damaged by improper storage or accident or that is subject to alteration misuse tampering or abuse Before returning any defective components you must obtain a Return M aterial Authorization number and return instructions from H emoSense T echnical Support by calling 1 877 436 6444 HEMOSENSE SENTIRE LIABILITY INCONNECTION WITH THE METER REGARDLESS OF THE LEGAL OR EQUITABLE BASIS OF ANY CLAIM ISLIMITED TO THE PURCHASE PRICE OF THE METER IN NO EVENT WILL HEMOSENSE BE LIABLE FOR ANY INCIDENTAL INDIRECT SPECIAL CONSEQUENTIAL OR PUNITIVE LOSS OR DAMAGESIN ANY WAY RELATED TO THE METER 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 50 warranty Glossary of Terms listed alphabetically Capillary Blood Blood from the smallest blood vessels of the body usually obtained from a fingersick Cleaning Door T he door on the front ofthe IN Ratio meter that can be opened to perform routine cleaning Data Port Port located on the top left side of the meter for connecting to a printer Electrodes T he component on the test strip that allows the meter to measure impedance Fingerstick A small puncture to the finger Hanging Drop A drop of b
16. h the IN Ratio meter IN Ratio T est Strips Box of 48 0100139 48 test strips for use with the IN Ratio meter IN Ratio Power Supply 0100011 U S Power supply for use with the IN Ratio meter U nistik L ancets Box of 50 0902009 U nistik 2 single use lancets 21g 2 cust omer service infor mat ion Use of the INRatio System T he IN Ratio system performs Prothrombin T ime PT testing on fresh capillary whole blood ThePT test is the principle assay used to monitor warfarin therapy T he dosage of warfarin should be adjusted based on test results to recommended therapeutic ranges T he thromboplastins used in performing PT tests can vary substantially causing differences in results between methods T he International N ormalized Ratio IN R is a mathematical correction of the PT result that adjusts for differences in thromboplastins T he American College of Chest Physicians makes these recommendations regarding IN R ranges for patients on oral anticoagulation therapy Indication INR Prophylaxis of venous thrombosis 2 0 3 0 T reatment of venous thrombosis 2 0 3 Treatment of pulmonary embolism 2 0 3 0 Prevention of systemic embolism 2 0 3 0 T issue heart valves 2 0 3 0 AMI 2 0 3 0 Valvular heart disease 2 0 3 0 Atrial fibrillation 2 0 3 0 Mechanical prosthetic valves high risk 2 5 3 5 Bileaflet mechanical valve in aortic position 2 0 3 0 3 useoftheinratio system Installation Your INRatio meter comes with You will also ne
17. he sample based on calibration information entered as a Strip Code and reports them on the display Please see the following pages for a diagram of the meter and test strip 6 principles of operation The INRATIO Meter Top View Display A OK Button Zn UP DOWN Button gt MENU Button u Cleaning Door Sample Light Test Strip Guide 7 theinRatio meter top view The INRATIO Meter Bottom and End Power Jack Data Port Battery Door Release Battery Door 8 the INRatio met er bottomand end The INRATIO Test Strip 9 theinRatiotest strip Performance Characteristics and Product Specifications Operating Conditions T emperature 50 95 F 10 35 C H umidity 10 95 without condensation Atmospheric Pressure 700 hPa 1060 hPa Memory 60 tests with time and date Data Port RS232 Power Battery 4 x 1 5v AA alkaline batteries not included AC Input 120v Output 7 8v DC U se only H emoSense Part 0100011 power supply or damage to meter may result Size 6 2 X 3 x 2 25 in 15 7 x 7 6 x 5 7 cm Weight W ithout batteries 8 1 oz 230 g W ith batteries 11 6 oz 330 g 10 performance characteristics and product specifications UL Classification lite US Medical Electrical Equipment W ith respect to electrical shock fire and mechanical hazards only in accordance with UL 2601 1 CAN CSA C22 2 No 601 Class Il Internally Powered E quipment T ype BF Applied Part Conti
18. igit c Press the OK button again to proceed Kir NOTE If an invalid strip code is entered an error message will be displayed for a short time then the meter will return to the Strip Code screen and allow you to re enter the correct code 5 If necessary the meter will now warm up to operating temperature 13 performing atest cont inued Action 6 T he meter will beep when it has completed the warm up the message APPLY SAM PLE will appear in the display and the green light on the meter will appear under the sample well on the test strip EF NOTE For fingerstick instructions see Section IV 7 Apply a large hanging drop of blood at least 15uL to the sample well on the test strip over the green light Do not move the meter during testing 8 After a few seconds the meter will beep signaling that the sample is accepted T he meter will now perform the test If the meter does not beep and begin processing not enough blood was applied Do not attempt to add more sam ple Begin again at Step 3 with anew test strip and perform a new fingerstick If the meter begins the test but does not detect enough sample an error message will be displayed Do not attempt to add more sample Begin again with a new test strip If the results are unusually low or high repeat the test 14 performing atest continued Meter Display APPLY SAMPLE Action Meter Display 9 When testing is complete the
19. ion of blood clots 51 glossary of terms
20. leach solution or 70 isopropyl alcohol may be used Do not immerse the meter in any liquid Do not use any abrasive cleaner W hen necessary clean the area around the test strip guide by lifting the cleaning door and cleaning underneath with a swab or pad that has been wetted with alcohol or a5 bleach solution AA maint enance and cleaning Installing Batteries Batteries should be replaced when aBAT TERIES LOW messages appears on the meter display Batteries are not necessary if you are using the AC adapter T o replace the batteries 1 T urn the meter upside down 2 Remove the battery door by pressing down on the battery door release 3 Remove the old batteries and replace with four new standard AA batteries T he direction for battery d placement is shown inside the battery compartment ie FPS i ad Ka i N b h es ee ee Tara aki A N won s on EN z REG el 7 mer ase x u rer eet rn _ a m un P un etc 4 Replace the battery door 45 installing batteries Troubleshooting In this section you will find information on how to resolve most problems that you might encounter If you have any questions or problems during the troubleshooting process feel free to call H emoSense T echnical Support W e are available 24 hours day seven days week Error Screen ERROR SAMPLE APPLIED TOO EARLY ERROR HOT ENOUGH i ERROR STRIP CODE ERROR 411 a Action to Take
21. lf test SELF TEST VERSIONE INSERT STRIP 2 W hen the self test is complete the meter will prompt for a new test strip far NOTE If an error message appears consult the troubleshooting section 3 Press the MENU button to view the M ain Menu 4 Press the UP DOWN button to highlight CHANGE SET UP Press the OK button to select 25 change set up setting the date Change SetUp Setting the Date continued Action Meter Display DATE 1 1 00 5 DATE will be highlighted Press the OK button to select it TARGET OFF 6 T he choices for the date format will be displayed MM DD YY wir Push the UP DOWN button to choose a format Push OK to select DD MM YY 7 T he date will appear on the display as currently set with the month highlighted er Press the UP DOWN button to change the month 121 1 300 W hen correct pressthe OK button to select 8 T he day will now be highlighted Press the UP DOWN button to change the day W hen correct press the OK button to select 9 T he year will now be highlighted Press the UP DOWN button to change the year W hen correct press the OK button to select 26 change set up set ting the date cont inued Change SetUp Setting the Date continued Action Meter Display 9 Pressthe MENU button to return to the Change Setup M enu T he meter will cue you if you have selected a day past the number of days in that month Go back and enter the correct day if
22. lood that forms after a fingerstick that is large enough to hang from the fingertip Collecting a hanging drop helps to ensure that an adequate sample at least 15uL is being applied Hemoglobin T he oxygen carrying pigment and predominant protein in the red blood cells Hemolysis T he destruction of red blood cells leading to the release of hemoglobin from within the red blood cells into blood plasma H emolysis should be avoided because it may interfere with the PT test Impedance Resistance that opposes the flow of alternating current conductivity Example T he InRatio meter uses impedance to measure Prothrombin T ime Interstitial Fluid Fluid between the cells in the body International Normalized Ratio INR Standardized system of reporting PT that takes into account the different sensitivity of thromboplastins used in various methods IN R results are comparable across PT measurement systems In Vitro Diagnostic A diagnostic test done outside the body Lancets A sharp pointed instrument example needle used to make a small incision or fingerstick to collect the small drop of blood used in performing aPT test Mechanical Prosthetic Valves A synthetic mechanical substitute for a natural human heart valve Oral Anticoagulant Any oral agent example C oumadin used to prevent the formation of blood clots Plasma T he liquid part of blood Power Jack T he power port located on the top right hand side of the me
23. mbin T ime testing on the IN Ratio system T he H emoSense IN Ratio meter is for quantitative Prothrombin T ime testing with IN Ratio Prothrombin T ime IN R test strips Please see the Package Insert which accompanies the T est Strips for additional information T he IN Ratio system is for in vitro diagnostic use only If you have any questions regarding the use of the IN Ratio system contact H emoSense T echnical Support at 1 877 436 6444 24 hours day seven days week Please access our website at http www hemosense com for additional information Ha NOTE Please read the entire manual and undergo proper training and practice before attempting to use the INRatio system 1 introduction Customer Service Information For additional information regarding H emoSense IN Ratio meters test strips or accessories please contact our customer service department T hey can be reached at H emoSense ATTN Customer Service 651 River O aks Parkway San Jose CA 95134 USA H ours 7 00 am 5 00 pm Pacific Standard T ime M onday Friday T oll Free 1 877 436 6444 International 1 408 719 1393 Fax 1 408 719 1184 E Mail moreinfo hemosense com W eb www hemosense com Product Part N umber D escription IN Ratio Professional K it 0100004 Includes IN Ratio M eter Power Supply 50 L ancets Professional U sers G uide Quick Reference G uide and T raining Video IN Ratio T est Strips Box of 12 0100071 12 test strips for use wit
24. meter will beep and the results will appear on the display with a QC OK message or actual QC results confirming that the low and high controls are in range T he actual display screen will vary depending on units selected 10 Remove the test strip and discard in a puncture proof container Record the results or print as appropriate DATE INR TIME Results are stored in memory with time and date nn Refer to Section V M ain M enu Fundionsfor additional information O02 HR STRIP CODE XAXXX 11 If a printer is attached to the IN Ratio meter and the Printer option has been selected press OK and the following message will appear on the display 12 Press OK to print the test results W hen printing is complete the meter will prompt to run another test 15 performing atest continued Action Meter Display Far NOTE If the onboard controls are out of range or an error message is displayed follow the instructions in the Troubleshooting ERROR QC 1H section or call HemoSense Technical Support for assistance 13 If the T arget Range option is in use and the result is out of the selected target range an ABOVE TARGET or BELOW TARGET message will appear with the test results see Section V Main M enu Functions on page 21 for instructions on setting a target range TIME INR lt 0 7 14 If the result is outside the measuring range of the meter ac OK the result will appear as gt
25. new test strip INSERT Ki NOTE If an error message appears consult the troubleshooting section 3 Pressthe MENU button to view the M ain Menu REVIEW MEMORY will be highlighted Press the OK button to select T he result of the last test will appear on the display T he result will be displayed in the units you have sdected far NOTE Press the UP DOWN button to scroll through the options in the main menu 23 review memory Review Memory continued Action Meter Display If there are no tet resultsin memory the mesage MEMORY EMPTY will appear MEMORY 4 If you wish to print the current result and the optional printer is attached press the OK button and the meter will ask if you want to print Press OK to print the current result or any other key for no 5 If you wish to see previous test results press down on the UP DOWN button Press up or down on the UP DOWN button to move forward or back in the memory 6 Pressthe MENU button when finished to return to the M ain Menu 7 If you wish to perform a test at this time highlight Run T est in the menu by pressing the UP DOWN button Press the OK button to select T o turn off the meter highlight TURN METER OFF by pressing the UP DOWN button Press the OK button to select 24 review memory cont inued Change SetUp Setting the Date Action Meter Display PERFORMING 1 Press any button to turn on the meter T he meter will begin a se
26. nuous O peration 11 ul classification Il Performing a Test Action Meter Display Follow these steps to perform a test Hr NOTE Allow a test strip pouch to reach room temperature before starting this procedure PERFORMING 1 Press any button to turn on the meter SELF TEST T he meter will automatically perform a self test and display the software version VERSION pm Hr NOTE If an error message appears consult the troubleshooting section of this manual INSERT STRIP 2 W hen the self test is complete the meter will prompt for a test strip 3 Remove the test strip from the foil pouch and insert it into the test strip guide until the meter beeps and displays a strip code T he strip has been properly inserted when the words on the strip are readable to the operator 12 performing atest Action Meter Display CAUTION The strip code must be correct or the results may be inaccurate 4 Check the strip code on the test strip pouch or strip container STRIP CODE f the strip code on the display matches the strip code on the strip pouch or strip AA11A container pressthe OK button and continue to step 6 If the strip code on the display does not match the strip code on the strip pouch or strip container STRIP CODE a Pressthe UP DOWN button to highlight and change each digit one at a time H old down the button to scroll through the letters and numbers b Press the OK button to select each changed d
27. ter for use with a IN Ratio power adapter 120 volt Prothrombin Time PT T he clotting test done to test the extrinsic coagulation pathway Pulmonary Embolism T he obstruction of the pulmonary artery or abranch of it leading to the lungs by a blood clot Quality Control T he testing done to show that a system is working properly and giving dependable results Reagent A substance used to produce a chemical reaction to measure a substance or process such as a Prothrombin T ime test Sample Light G reen light on the test strip guide that is directly under the sample well of an inserted test strip T his light helps users identify where to place the blood sample on an IN Ratio strip Sample Well Round target on the single use H emoSense test strip where the blood sample is applied Strip Code C ode entered and used by the IN Ratio system that corresponds to the code identified on the IN Ratio strip box this code should be entered for each new lot Systemic Embolism T he obstruction of a blood vessel by an abnormal particle example air bubble circulating in the blood system Test Strip H emoSense single use test strip used to perform the Prothrombin T ime Thromboplastins A substance used by blood platelets and combined with calcium that converts prothrombin protein into thrombin enzyme as part of the clotting cascade Venous Thrombosis A clot formation in the veins Warfarin An oral agent used to prevent the format
28. tes uses and can radiate radio frequency energy If it is not installed and used in accordance with instructions it may cause interference to other devices in the vicinity Call H emoSense T echnical Support for help in determining whether your IN Ratio meter is causing interference and how to correct any interference Any equipment connected to the data port must be certified to IEC 60601 1 1 If you connect any equipment that is not recommended by H emoSense you are responsible for compliance with this stan dard Please contact H emoSense T echnical Support if you have any questions U se only H emoSense Part 0100011 Power Supply or damage to meter may result E Class II Equipment T he meter is double insulated T ype BF Applied Part T he meter has conductive contact with the patient A Biological Risks D isposable items pose biological risks 42 hazards IX Service and Maintenance In this section you will find information on Maintenance and C leaning Installing Batteries Service and T roubleshooting W arranty If you have any questions or problems call H emoSense T echnical Support W e are available to answer questions 24 hours day seven days week at 1 877 436 6444 43 service and maint enance Maintenance and Cleaning No maintenance is required other than routine cleaning Clean the outside of the IN Ratio meter with a clean damp cloth If necessary a mild detergent or disinfectant such as a 5 b
29. this occurs 10 Pressthe MENU button to return to the M ain M enu 11 If you wish to perform a test at this time highlight RUN TEST in the menu by pressing the UP DOWN button Press the OK button to select T o shut down the meter highlight TURN METER OFF by pressing the UP DOWN button Press the OK button to select 27 change set up setting the date continued Change SetUp Setting the Time Action Meter Display PERFORMING 1 Press any button to turn on the meter T he meter will begin a self test SELF TEST VERSION m 2 T he meter will prompt for a new test strip Far NOTE If an error message appears consult the troubleshooting section 3 Pressthe MENU button to view the M ain Menu 4 Pressthe UP DOWN button to highlight CHANGE SET UP Press the OK button to select 28 change set up setting thetime Change SetUp Setting the Time continued Action 5 Press the UP DOWN button to highlight TIME Press the OK button to select T he choices for time format will be displayed Push the up down button to choose a format Push OK to select T he time appears on the display with the hour highlighted Press the UP DOWN button to change the hour W hen the hour is correct press the OK button to select T he minutes will now be highlighted Press the UP DOWN button to change the minutes W hen the minutes are correct press the OK button to select Ifthe 12
30. tton to select A screen will appear that will allow you to set a target range 8 Pressthe UP DOWN button to change each number one at atime Press the OK button to select each digit and move to the next digit 9 Pressthe MENU button when your custom range is set properly T he meter will cue you if you try to set the lower end of the range higher than the high end or if you set the lower or upper limit outside the measuring range of the meter 0 7 7 5 IN R 34 using thetarget range feat ure continued Using the Target Range Feature continued Action Meter Display 10 Pressthe MENU button to return to the M ain M enu 11 If you wish to perform a test at this time highlight RUN TEST in the menu by pressing the UP DOWN button Press the OK button to select 12 T o shut down the meter highlight TURN METER OFF by pressing the UP DOWN button Press the OK button to select far NOTE Manual shutdown is recommended when meter is on battery power 35 using the target range feat ure continued Change SetUp Choosing the Printer Option Action Meter Display 1 Press any button to turn on the meter T he meter will begin a self test PERFORMING SELF TEST VERSION F 2 T he meter will prompt for a new test strip 3 Pressthe MENU button to view the M ain M enu 4 Press the UP DOWN button to highlight CHANGE SET UP Press the OK button to select 5 Press the UP DOWN button to highlight
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