CoaguChek XS - Medicinas preces
Contents
1. touch or remove the test strip during a test Wi wait more than 15 seconds after lancing the fingertip before apply ing the blood add more blood after the test has begun perform a test with a drop of blood from a previous puncture AN Failure to comply with the above may lead to inaccurate results 45 English Testing a capillary blood sample Getting a good capillary blood sample To get a suitable drop of blood W Wash your hands in warm water and dry thoroughly Residues of water on the skin can dilute the drop of blood and Z so produce false results m Let your hand hang at your side before lancing your finger W Immediately after lancing massage gently along the side of your finger to obtain a sufficiently large blood drop without pressing or squeezing too hard The CoaguChek Softclix lancing device is intended only for A patient self monitoring by a single person It must not be used to collect blood in a multi patient setting as it does not incorporate any features to guard against cross infection 46 Preparing to test Testing a capillary blood sample Have the test strip container to hand Make sure that the code chip belonging to these test strips is inserted in the monitor Prepare the lancing device by inserting a fresh lancet Do not lance your finger until asked to do so further on in this description 47 English Testing a capillary blood sample Per2. We recommend obtaining the capillary blood from the side of the fingertip as this causes least pain Massage the lanced finger until a drop of blood is formed Do not press or squeeze the finger Apply the first drop of blood from the finger The CoaguChek Softclix lancing device is intended only for patient self monitoring by a single person It must not be used to collect blood in a multi patient setting as it does not incorporate any features to guard against cross infection 53 English Testing a capillary blood sample 11 Apply the blood directly from the finger to the semicircular transparent sample applica tion area of the test strip Testing a capillary blood sample Alternatively you can touch the blood drop against the side of the sample applica tion area instead of applying it to the centre from above The test strip draws up the blood by capillary action During this process you must hold the blood drop to the test strip until the flashing blood drop symbol has disap peared and the monitor beeps provided the beep tone is turned on Apply the blood drop to the test strip within 15 seconds of lanc ing the fingertip Applying blood after this period of time would falsify the result as the coagula tion process would already have begun 55 English Testing a capillary blood sample You hear a beep tone when you have applied enough blood pro vided the beep tone is turned
3. high or a down arrow too low 59 English Testing a capillary blood sample 60 A c is displayed along with the result This may occur if the haematocrit value is very low or due to erroneous blood collection e g wet hands Repeat the measure ment and make sure that your hands are dry If the message persists please contact your healthcare professional for a haematocrit check You can temporarily change the unit in which the result is pre sented by pressing the Set button while the result is dis played Each press of the button takes you to the next available unit Q Sec INR When you next perform a test the result is again displayed in the standard unit you selected during setup Testing a capillary blood sample The valid measuring ranges for CoaguChek XS PT test strips are W INR 0 8 8 0 W Q 120 5 B Sec 9 6 96 Results that are outside the measuring range are indicated by the symbols gt greater than or smaller than and flashing In this case refer to the section Test limitations and known inter ferences in the package insert supplied with the test strips and repeat the test 61 English Testing a capillary blood sample Testing by healthcare professionals Follow the appropriate infection control guidelines in force in your facility W Wear protective gloves m Wash or disinfect the patient s finger and allow it to dry thoroughly Residu
4. Setting the time format Now select the time format You can choose between the 24 hour time format presetting and the 12 hour time format with a m or p m 9 Press the M button to toggle between 24 hour and 12 hour format 10 Press the Set button to save the correct setting and con tinue with the time setting set The display automatically moves on to the time setting 34 Setting the time First you set the hour then the minutes 11 12 Monitor setup Pressthe M button to change the number that is currently flashing Press the Set button to confirm You can now set the minutes again using the M button If you have selected the 12 hour time format a m changes to p m and vice versa when you reach 12 xx Press the Set button to save this setting and continue with selection of the unit for reporting the result 35 English Monitor setup Selecting the unit Choose the coagulation unit you wish the monitor to use to display the result The options are W Q m Sec W INR presetting AN Ask your doctor if you are not sure which unit to select The current coagulation unit flashes 13 Press the M button to cycle through the three options 14 Press the Set button to save the correct unit The display then automatically moves on to the beep tone setting 37 If you have selected INR as your coagulation unit you have the option o
5. Softclix lancing device is intended only for A patient self monitoring by a single person It must not be used to collect blood in a multi patient setting as it does not incorporate any features to guard against cross infection Please note This manual contains all the information you need to operate and care for the CoaguChek XS System Please read this entire manual carefully before you use the monitor Last update user information 2008 03 English The CoaguChek XS System The CoaguChek XS System 3 Introduction 9 The CoaguChek XS System 9 Test principle 10 Contents of the pack ees 10 Operating conditions sees 11 Quiaality control i retro chaton 12 About this manual 13 Manual formatini 13 The CoaguChek XS monitor 16 The CoaguChek XS monitor 17 Bette se 18 Starting up 19 Inserting the batteries 20 Code chip 23 Inserting the code chip eeeseeesssssseesssssssssssseesssssesseeetsesssceeseeeetenssseeet 24 Monitor setup 26 Settings summary ettet tsnsene 27 Setting up the monitor Set Mode 28 Setting the date format S tting the date Roca duties deiszatecestaht ts Setting the time format Setting the time tttttttccnenn Selecting the unit Setting the beep tone Setting the therapeutic range INR 38 English Testing a capillary blood sample Important notes aa Getting a good capillary blood sample Preparing to test Performing a test Notes concern
6. and symbols is provided in this User s Manual starting on page 94 75 English Error messages Error messages overview Error message always prefaced by error Brief description Test strip Test strip in monitor or 78 o Cm test strip unusable or the test 82 i strip is nota CoaguChek XS PT test strip Temperature symbol Monitor too warm or too cold 78 flashing E Battery symbol flashing I Battery level too low 80 Cover symbol X Measurement chamber cover 80 flashing C gt open IR symbol Infrared download error 92 flashing f QC symbol flashing Qc Quality control test strip 88 unusable Code symbol code Code chip error 82 flashing 76 Error messages Error message always Brief description prefaced by error Error number GGG Allowed time for blood 86 application exceeded Error number 3 Beyond expiry date 84 Error number H Test strip unusable 84 Error number 5 Blood application error 86 Error number amp Measurement error 88 Error number 1 Measurement error 90 Error number B Diagnostic testing error 92 Error numbers 1 and 2 are reserved for internal purposes by Roche 77 English Error messages Error messages after turning the monitor on Display Description of error Error test strip A test strip was already inserted when the monitor was turned on with the On Off button Error ambient temperature The monitor is too cold or too warm t
7. customer service 89 English Error messages Display Description of error Error measurement Measurement error resulting from the blood sample 90 Error messages Solution Turn the monitor off and remove the test strip Repeat the measurement using a new test strip and blood taken from a new puncture site at the tip of another finger Do not touch or remove the test strip when a test is in progress Note on Error 7 Measurement The CoaguChek XS PT test strip may be used for patients under a combination therapy of oral anticoagulants plus heparin injections For maximum heparin concentrations which do not interfere with the test please refer to the package insert Under no circumstances however should heparinized capillary tubes be used for sample application If capillaries are used please use only the dedicated CoaguChek capillary tubes Be sure to apply the blood drop to the test strip within 15 seconds of lancing the fingertip This error message 7 can occur in rare cases i e in patients A with long coagulation times gt 8 INR lt 5 Quick If this error message appears again when you repeat the test your results must be checked using another method Please contact the doctor treating you immediately 91 English Error messages Display Description of error Error diagnostic test Error during the internal diagnos tic test which the monitor per forms Error message during infrared d
8. format the entire date display flashes The display options are as follows W 31 12 00 presetting Day Month Year W 12 31 00 Month Day Year Wi 00 12 31 Year Month Day When elements in the display are surrounded by a halo it indicates that they are flashing in the monitor s display Pressing the Set button takes you to Set Mode This is indicated by the word set in the display 1 Press the M button to select the date format 31 12 00 flashes in the display You can now select the date format 2 Press the Set button to save this setting and continue with the date setting The display automatically moves on to the date setting 31 English Monitor setup Setting the date The next three settings involve entering first the year then the month and finally the day 32 Press the M button to change the number that is currently flashing and set the current year Press the Set button to save the year The display then automatically moves on to the month setting The preset month flashes Press the M button until the correct month is displayed Press the Set button to save the setting The display then automatically moves on to the day setting Monitor setup 7 The preset day flashes Press the M button until the correct day is displayed 8 Press the Set button to save the setting The display then automatically moves on to the time format setting 33 English Monitor setup
9. of the monitor and lift off the cover 3 Insert the four batteries in the battery compartment as indi cated Pay attention to the positions of top of bat tery and flat end Once you have inserted the batter ies the monitor turns itself on after about 5 seconds Only use alkaline manganese batteries 1 5 V AAA Think of the environment Dispose of used batteries sensibly 20 E Ben sm X x BB BB BB mem iL e ost so wel HN ur Ws INR E rmt Starting up 4 Close the battery compart ment 5 Check that all of the display symbols are displayed prop erly Results may be misread if a segment is missing Tip If the display check when you turn on the monitor is too quick you can putit on hold by pressing and holding down the On Off button T the next time you turn the monitor on For as long as you keep the button pressed the display remains frozen 21 English Starting up 6 Onthe next screen that appears check that the date and time are correctly set If these have not yet been set or if they have been lost because the batteries were removed from the monitor for more than one minute your CoaguChek XS monitor now automatically enters Set Mode After you have set the date and time the monitor enters Test Mode If you wish to enter any further settings turn to the chapter Setting up the monitor Set Mode start ing on page 28 7 Turn the
10. on The blood drop symbol dis appears and the test starts Do not add more blood Do not touch the test strip until the result is displayed ted iro sud 56 The monitor now performs an automatic quality control check on the test strip QC appears in the display Following a successful outcome of the quality control check a tick appears after QC 7 IEr sr B Testing a capillary blood sample It is at this point that the coagula tion measurement begins The hourglass flashes until the moni tor has the result The result is displayed in the unit you chose when setting up the monitor It is automatically saved to memory You can change the unit if you wish by pressing the Set button while the result is dis played see page 60 Enter the test result in your patient logbook When interpret ing your result please also read the test strip package insert care fully 57 English Testing a capillary blood sample 58 12 Remove the test strip from the measurement chamber 13 Turn the monitor off 14 Discard the used lancet and test strip with your regular household waste 15 Clean the monitor if this becomes necessary see page 71 Testing a capillary blood sample Notes concerning the results display If your results are displayed in INR and you have activated the relevant option values that are outside a defined target range are flagged with an up arrow too
11. pressing the On Off button Then enter the monitor setup again by turning on the monitor with the Set button and press the Set button repeatedly until you reach the setting you wish to change 41 English Monitor setup 42 Testing a capillary blood sample Testing a capillary blood sample What you need CoaguChek XS monitor The code chip already inserted in the monitor each test strip container has its own code chip Test strips belonging to the code chip mentioned above Lancing device e g CoaguChek Softclix Lancet e g CoaguChek Softclix Lancet Lint free swab or paper tissue 43 English Testing a capillary blood sample Important notes Always Wi close the container immediately after having removed a test strip Wi operate the monitor at an ambient temperature between 18 C and 32 C Wi place the monitor on a level stable surface table or hold it so it is roughly horizontal Wi follow the information on correct handling of test strips in the package insert Wi keep the test strip guide and housing clean See also the chapter entitled Cleaning page 71 44 Testing a capillary blood sample Never Wi store the monitor at extreme temperatures Wi store the monitor in damp or humid conditions without protection Mm remove or insert the code chip while the monitor is performing a test Wi use the code chip from a pack other than the one in use Wi
12. 60 Results can be downloaded from memory via an inbuilt infrared inter face Please note When downloading results via the infrared interface avoid strong stray light as this can cause the download to break off see page 92 For more information on downloading results to a suitable system such as a PC please call your local customer support and service centre see page 100 67 English Memory Erasing memory You can erase the entire memory from your CoaguChek XS monitor You cannot however erase individual results 1 Place the monitor which must be turned off on a level vibration free surface or hold it so it is roughly horizontal 2 To turn the monitor on first press and hold down the M button then press the On Off button as well and hold down both buttons for at least 5 seconds 68 Memory The monitor runs the usual dis play check and then displays mem flashing and clr The number of results in memory is shown in the top right corner of the display 3 Press the M button to con firm that you wish to erase the entire memory To exit Erase Mode without erasing the results press the On Off button instead 69 English Memory The hourglass flashes while the results are being erased The counter is set to 0 and three bars are displayed indicating that there are no results saved in memory the entire memory has been erased 70 Cle
13. EALI 31 Display BUY GCs UC oY aT cy 9 6 dte 21 48 SVMDONS Rati tah 94 96 DISPOSAl E 18 20 24 25 58 99 E Electromagnetic interference tees 11 Error messages cuiii bir rbi laeta riii 75 93 F xeu M 53 G erase C 9 101 H miUia E M 11 I Information service e ssssssttsstttttrtnnsssattettttttcttsas 100 Infrared interface uiua sime iait 67 92 L Lancing your finger e tttttttttttnnntccettn 53 103 English Alphabetical index M Mib ttoni su eat ed datis fa ai t ea uy Measurement chamber cover erasing ere tpe ire Rep edit bones Monitor SEUD n T DRM MANT MD Ld 26 41 Monitor guide zinc tco eed aecenas 17 0 Operating conditions rnnt 11 98 Ordering P Prothrombin time sccsssssscssssecsssesssssesessssessssscssssseesssseesssseerssseesssseesssseeessneesssseeessneeessees 9 Q Quality CORO ciam toties fepe pte 56 R ReSUlE riter uc tet ETETA 57 selecting the coagulation unit es 36 104 Alphabetical index S Set DUT N c 28 NM 26 41 SIR C MN 37 dale hates 32 dat FOAL sssini aa 31 setting up the monitor oaaaaeeeessessseeeessseccscecsssseeesessseesecessneeseeeceeeeessnnetees
14. PEDI TE S TOONDE CoaguChek XS User s Manual Manuale per l uso On the packaging on the type plate of the monitor and in the User s Manual you may encounter the following symbols and abbreviations shown here with their meaning z LOT IVD E pH A N Use by Expiry date Lot number For in vitro diagnostic use This product fulfills the requirement of Directive 98 79 EC on in vitro diagnostic medical devices Catalogue number Please consult instructions for use Caution refer to accompanying documents Please refer to safety related notes in the manual accompanying this instrument Manufacturer Store at The CoaguChek XS System The CoaguChek XS System The CoaguChek XS System is used for quantitative monitoring of coagu lation values common terms thromboplastin time PT Quick value with CoaguChek XS PT test strips Self monitoring and self adjustment of oral coagulation therapy using coagulation values determined with the aid of the CoaguChek XS System may only be undertaken after consultation with your doctor and compre hensive instruction by a qualified healthcare professional Your pharma cist specialist supplier can provide you the training and or put you in touch with associations or institutions offering training in coagulation self monitoring Please read the special notes on INR self monitoring in the package insert accompanying the test strips The CoaguChek
15. a Roche Diagnostics Australia Pty Ltd 31 Victoria Ave Castle Hill NSW 2154 Telephone 02 98997999 New Zealand Roche Diagnostics N Z Ltd 15 Rakino Way Mt Wellington Auckland Telephone 09 2764157 Please note that repairs and other modifications to the monitor may only be performed by persons authorized by Roche Diagnostics 100 Guarantee Guarantee The statutory guarantee provisions on rights in consumer goods sales in the country of purchase shall apply The following U S Patents have been granted for the CoaguChek XS System meter and test strips 6 662 439 7 073 246 6 645 368 6 881 378 6 207 000 7 049 131 7 084 251 5 625 036 7 338 639 Additional U S Pat ents pending COAGUCHEK and SOFTCLIX are trademarks of Roche 2008 Roche Diagnostics All rights reserved 101 English Alphabetical index Alphabetical index A Altitude operating conditions Applying blood ee B Batteries SETIN ioca uus in Gun nena eae eet LL AE 37 Blood sample testing e eeteetnennnnccas 43 63 C Capillary blood sample testing 43 63 I e 71 74 by healthcare professionals sees 74 test strip guide Coagulation process Coagulation UNIS nsii Code ChIP sinana Pte hne COME MUMDER de inserting Collecting blood 102 Alphabetical index D Br cm ia 32 B
16. aning Cleaning Cleaning the housing Clean the monitor whenever it becomes dirty Turn off the monitor before cleaning it Use only the following items for cleaning W Ordinary lint free swabs available at pharmacies W Warm water with or without washing up liquid m Soft lint free moistened cloth or cotton bud Do not use sprays of any sort as these may enter the monitor Z and damage it 1 Clean the outside of the monitor with a lightly moistened cloth 2 Then dry the monitor with a fresh cloth 71 English Cleaning Cleaning the test strip guide Check the test strip guide regularly for signs of soiling If the test strip guide has become soiled with blood or any other material you must clean this area 1 Remove the measurement chamber cover by pressing upwards from the front e g using your thumb nail You can rinse the detached meas urement chamber cover sep arately from the monitor with water 2 Clean the easily accessible white areas with a lint free swab or a moistened cotton bud Make sure that no liquid enters the monitor Do not insert any objects in the test strip guide Doing so may damage the electrical con tacts behind the test strip guide 72 On completion of cleaning test strip holder Cleaning Let the inside of the test strip guide dry for about 10 minutes After this time re attach the measurement chamber cover to the housing ensuring that the
17. at all segments of the symbols are showing 15 English The CoaguChek XS monitor The CoaguChek XS monitor The CoaguChek XS monitor The CoaguChek XS monitor A Display E Test strip guide Shows results information symbols and results recalled from memory M memory button Press this button to recall results from memory and to change the monitor settings You also press this button to confirm the code number dis played before each test On Off button Press this button to turn the monitor on or off Measurement chamber cover Remove this cover to clean the test strip guide Insert the test strip here Battery compartment cover Covers the battery compart ment 4 1 5 V alkali manga nese batteries type AAA Code chip slot Insert the code chip here Set button Press this button to enter or change the monitor settings Infrared window You can transfer data stored in memory via this infrared interface English The CoaguChek XS monitor Batteries To save power the CoaguChek XS monitor automatically turns itself off after 3 minutes unless a button has been pressed or a new test strip has been inserted When the monitor turns itself off all results obtained up to that point remain in memory The monitor briefly indicates the battery power level when it is turned on The battery symbol is divided into four segments which correspond to the battery power level When replacing the batter
18. ate generating an electrochemical signal Depending on the time elapsed when it first appears this signal is then converted by means of an algorithm into customary coagulation units INR Quick seconds and the result is displayed Contents of the pack CoaguChek XS monitor 4 alkali manganese batteries 1 5 V type AAA CoaguChek Softclix lancing device with instructions for use CoaguChek Softclix Lancet System carry case User s Manual Introduction Operating conditions To ensure that your CoaguChek XS System functions properly please observe the following guidelines W Only use the monitor at a room temperature between 18 C and 32 C W Only use the monitor at a relative humidity between 10 and 85 W When testing place the monitor on a level vibration free surface or hold it so it is roughly horizontal Ifthe monitor is to remain unused for a longer period of time keep it in the carry case supplied Wi Use the monitor only up to a maximum altitude of 4300 metres Electromagnetic interference Strong electromagnetic fields may interfere with the proper operation of the monitor Do not use the monitor near strong electromagnetic fields English Introduction Quality control The CoaguChek XS System has a number of inbuilt quality control functions such as W A check of the electronic components and functions every time the monitor is turned on m A check of the test strip temperature while a tes
19. c Results are displayed in seconds INR Results are displayed in INR units 94 Display information and symbols Symbol Meaning n Beep tone is turned on Un A nr Beep tone is turned off UFFA Result is above the chosen therapeutic range only with INR as unit Result is below the chosen therapeutic range only with INR as unit Ct Ge n Results in the chosen unit Error numbers Memory contains no results or no further results 6 38 Time in the format hour minutes BB BB BB Date in the format day month year month day year or year month day set The monitor is in Setup Mode code Gives the code number of the code chip presently inserted gt lt Result in the chosen unit is above the measuring range Result in the chosen unit is below the measuring range 95 English Display information and symbols Symbol Meaning Battery status When the batteries still have their full charge all segments are lit Individual segments disappear one by one as the batteries become weaker When there is no segment remaining you can no longer perform a test You can however still access the monitor s memory The monitor is in Memory Mode mem l QC v Il Automatic quality control completed success fully C Result for this blood test is flagged with a c due to a low haematocrit value or wet hands Reports an
20. eeeeeseenees 28 CIS 27 therapeutic range e tettttttnnnnnttttttttnnnnnacas 38 39 ju 35 HInEIUnrgee m 34 Me 36 Starting UP ineeie 19 25 Stray MIG N ssnstinin n 67 92 Symbols blood drop 52 summary type plate 105 English Alphabetical index T Target rafige ios e i aa aa E ae 38 59 SEWING att RR tte ed scl et 38 39 Technical datai ttt tertie tette e dale eite 98 Telephone number information service 100 Temperature range t stttttttttnnnsnanttttttttttnsssss 11 44 Test performing 2 5 dea aa SR e EO i peel 48 58 preparing astitit reete ite inerenti TTS 47 principle oue nte a teh tede ceat eds 10 Test strip inserting i ee e n aei 50 Symbol cus scite nti clara iecit tdt cutie e d 49 Therapeutic target range e tttttttnnnnnnccas 38 59 Settlrig ihi Rte tede meiden 38 39 Time 35 Duae 34 U Unit changing temporarily etttttttnnnnnnccas results INR Quick seconds 106
21. error see Error messages error Room or monitor temperature is outside the acceptable range Communication is taking place via the infra iz E red interface S A Measurement chamber cover is open 96 Further information Further information Ordering Please contact your pharmacist or specialist supplier CoaguChek XS PT Test REF 0 4625358 24 test strips CoaguChek XS PT Test REF 0 4625315 2 x 24 test strips CoaguChek Softclix Lancet REF 0 3506509 50 lancets Product limitations Please read the information in the package insert supplied with the test strips for detailed product data and limitations 97 English Product specifications Product specifications Operating conditions and technical data Temperature range 18 C to 32 C Relative humidity 10 to 85 no condensation Maximum altitude 4300 m Position Place the monitor on a level vibration free sur face or hold it so it is roughly horizontal Measuring range Q 120 5 SEC 9 6 96 INR 0 8 8 0 Memory 100 test results with date and time Interface Infrared interface LED IRED Class 1 Battery operation 4 x 1 5 V batteries alkali manganese type AAA Number of tests per set of batteries Up to 2 years or up to 300 tests depending on frequency of use Safety class Automatic power off After 3 minutes Dimensions 138 x 78 x 28 mm Weight 127 g without batterie
22. es of water or disinfectant on the skin can dilute the drop of blood and so produce false results m Use only a lancing device that is approved for use by healthcare pro fessionals for example the Safe T Pro Plus lancing device from Roche shown below Follow the manufacturer s instructions for use in a multi patient setting Wi Follow all health and safety regulations in force locally 62 Testing a capillary blood sample There is a potential risk of infection Healthcare profession AN als using the CoaguChek XS monitor to perform tests in more than one patient must be aware that any object coming into contact with human blood is a potential source of infection Healthcare professionals must also be aware that any cross contamination is a potential source of infection for patients See Clinical and Laboratory Standards Institute Protection of Laboratory Workers from Occupationally Acquired Infections Approved Guideline Third Edition CLS document M29 A3 2005 Getting a good capillary blood sample in a healthcare setting Wi Select and lance a puncture site along the side of a fingertip m Use gentle pressure massage the finger towards the fingertip to encourage a drop of blood to form approx 10 pL Follow the procedure for testing as outlined from page 47 Use only a lancing device that is approved for use by healthcare professionals for example the Safe T Pro Plus lancing device from Roche Disposal by hea
23. f entering your therapeutic target range If you enter this you will be able to see after every test whether the result is within your therapeutic target range see page 38 36 Monitor setup Setting the beep tone After you have set the unit you can choose whether you want the beep tone On or OFF If you have selected On the monitor will beep in the following situations B when it detects a test strip W when pre heating of the test strip is complete and you need to apply a sample B when it detects a sample m when the result is displayed and m if an error occurs three short beeps We recommend you leave the beep tone turned on 15 Press the M button to toggle between OFF and On On is the presetting 16 Press the Set button to save the chosen setting The dis play automatically moves on to the next setting option 37 English Monitor setup Setting the therapeutic range INR What happens next depends on the coagulation unit you have chosen for your results If you selected Q or Sec the settings are now complete and End appears in the display see page 40 If you selected INR as the unit you can now choose whether you want a further element to be displayed if the result is outside above or below your therapeutic target range If you switch on this display option an up or down arrow is displayed whenever the result is above or below the target range you have se
24. forming a test ABB tn y BEBEBE mem la LA Set so TIN Sec V ES ils Lm 48 1 Wash your hands with soap and warm water Dry them thoroughly Residues of water on A the skin can dilute the drop of blood and so produce false results 2 Place the monitor on a level vibration free surface or hold it in your hand so it is roughly horizontal Turn the monitor on by pressing the On Off button T Alterna tively you can insert a test strip to turn it on 3 Check that all of the display symbols are displayed prop erly as shown on the picture Results may be misread if a segment is missing Testing a capillary blood sample 4 Check the battery level If there are no bars left in the battery symbol you cannot perform any more tests 5 Check that the date and time are correct Correct any wrong entries as described from page 28 onwards 6 The flashing test strip symbol prompts you to insert a test strip Remove a test strip from its container Immediately after removing a test strip close the container again with the stopper Exposure to external influences e g humidity may deteriorate the test strips and may lead to error messages 49 English Testing a capillary blood sample 50 Hold the test strip so the lettering CoaguChek XS PT is facing upward Slide the test strip into the test strip guide in the direction indicated by the arrows Slide the
25. he symbols in the display The code chip accompanying the test strips contains lot specific information about these test strips including calibration data that allow the correct results to be calculated and the expiry date for the test strips You only need to insert the code chip turn the monitor on insert the test strip and apply a blood sample When the CoaguChek XS monitor is ready for a measurement the result will be displayed about 1 minute after application of the sample After the meas urement the monitor automatically stores the result in memory If you have any questions about the CoaguChek XS monitor please con tact your local customer support and service centre You will find contact details on page 100 Please note Before you use the monitor for the first time i e after you have first inserted the batteries you must set the date and time correctly to allow you to carry out measurements properly Each time you replace the batteries you need to check and if necessary adjust the date and time English Introduction Test principle The CoaguChek XS PT test strip contains a lyophilized reagent reagent in dried form The reactive components of this reagent consist of throm boplastin and a peptide substrate When a sample is applied thrombo plastin activates coagulation which leads to the formation of thrombin At the same time the monitor starts to measure the time The enzyme thrombin cleaves the peptide substr
26. ies you must insert the new batteries within one minute of removing the old ones to keep the date and time set tings If you take longer than this you must re enter the date and time Use only alkali manganese batteries type AAA The CoaguChek XS monitor is shipped with high quality batteries Since quality varies among different battery brands Roche recom mendis replacing your used batteries with new batteries of a similar high quality and not mixing different brands Do not mix new and already used batteries Please be aware that battery life may be affected by many factors such as battery quality operating conditions e g ambient tempera ture frequency of use and test duration Results are retained in memory together with the date and time even when no batteries are inserted All other settings are retained too Think of the environment Dispose of used batteries sensibly AN Do not throw batteries onto a fire They may explode Starting up Starting up Before using the monitor for the first time carry out the following steps 1 Insert the batteries 2 Insert the code chip you can also carry out this step immediately before testing 3 Set the current date and time 4 Select the coagulation unit in which the results are to be displayed 19 English Starting up Inserting the batteries 1 With the monitor turned off turn it over 2 Gently press the tab on the battery compartment cover towards the centre
27. ing that is in the monitor when it leaves the factory 27 English Monitor setup Setting up the monitor Set Mode All settings are entered with the Set button and the M button 1 If the monitor did not auto matically enter Set Mode when you turned it on press the Set button on the left side of the monitor to put it in Set Mode You can also press the Set button to change to Set Mode when the monitor is already turned on 2 If the currently displayed set ting is correct e g the date is correct and you only wish to change the time you can press the Set button to move on to the next setting or 28 Monitor setup Press the M button to change the setting that is currently flashing You may press the M button repeatedly or press it and hold it down until you have reached the correct setting Settings where there are only two options time format beep tone can be toggled on and off with the M button Press the Set button again to confirm the current setting which is saved to memory and move on to the next one 29 English Monitor setup 30 5 You can only move forward from one setting to the next not backward Corrections can only be made by repeat ing the settings You can exit the settings procedure at any time by pressing the On Off button T All settings you have already entered are retained Monitor setup Setting the date format First select the date
28. ing the results display Testing by healthcare professionals Getting a good capillary blood sample in a healthcare setting es 63 Disposal by healthcare professionals 63 Memory 65 Viewing test results ttt 65 Erasing mielTiQby petente tectis doceo 68 Cleaning Cleaning the housing Cleaning the test strip guide Cleaning by healthcare professionals 74 Error messages Error messages overview Error messages after turning the monitor on Error messages when preparing to test s Error messages after the code number was confirmed 84 Error messages during or after blood application Error message during infrared downloads Display information and symbols 94 Further information 97 Ordering ttc el ebat sane 97 Product limitations EEE PESEE E le te n EE 97 Product specifications 98 Operating conditions and technical data 98 Sample material Storage and transport conditions Disposal of the CoaguChek XS monitor Information service Repairs Guarantee 101 Alphabetical index 102 English Introduction Introduction The CoaguChek XS System The CoaguChek XS System CoaguChek XS monitor and CoaguChek XS PT test strips quantitatively determines prothrombin time PT Quick value INR using capillary blood from a fingertip or untreated venous whole blood The CoaguChek XS System makes coagulation testing easy The CoaguChek XS monitor guides you through the test step by step using t
29. lthcare professionals Dispose of used items in line with the disposal policy of your hospital institute or medical practice 63 English Testing a capillary blood sample 64 Memory Memory The CoaguChek XS monitor has a 100 value memory for saving results together with time and date Viewing test results 1 Place the monitor on a level vibration free surface or hold itin your hand so it is roughly horizontal 2 Press the M button to turn the monitor on in Memory Mode PI d nec nun The monitor runs the usual dis ILI 5 BED 08 g play check and displays the most mem recent result The display also shows mem signifying that this is a result from memory and not one that has just been obtained by testing The date and time of testing are also shown 65 English Memory 3 Press the M button again to move one result back in time When you have reached the oldest result the monitor displays a blank entry When all memory locations are full the oldest result is erased to make way for the most recent one n If no result has yet been saved the display looks similar but has mem a 0 in the top right corner ea em e INR Memory You can temporarily change the unit in which the result is dis played in the same way as directly following a test by press ing the Set button while viewing a result in memory Each press of the button takes you to the next available unit see page
30. monitor off again when the settings are cor rectly entered 22 Code chip Code chip The code chip provides the monitor with important information which it needs to perform the coagulation test The chip contains information about the test method the lot number and the expiry date The monitor is ready to use once the code chip has been inserted W Each time you test check that the correct code chip is inserted in the monitor m When you start each new pack of test strips you must remember to remove the old code chip from the monitor and replace it with the new code chip supplied with the test strips m Each code chip belongs to a particular lot of test strips Only remove the code chip when you are testing with test strips taken from a new pack with a new code chip Wi Protect the code chip from moisture and equipment which produces magnetic fields 23 English Code chip Inserting the code chip 1 Remove the old code chip if ib one is inserted in the monitor Discard the old code chip with your household waste 2 Always make sure that the number on the code chip matches the number on the label of the test strip con tainer AN Using the wrong code chip can produce incorrect results 24 Code chip 3 Slide the new code chip into ib the slot on the side of the monitor as shown until you feel it snap into place Every time you insert a test strip in the monitor the display shows the number
31. o measure correctly 78 Error messages Solution Remove the test strip The error message disappears the monitor is ready Turn the monitor off and allow it to stand for about 30 minutes at room temperature 18 C to 32 C 79 English Error messages Display Description of error Error battery Battery level too low Error messages when preparing to test Error cover The measurement chamber cover is not properly closed 80 Error messages Solution Insert new batteries as described on page 20 Close the measurement chamber cover The error message disappears the monitor is ready 81 English Error messages Display Description of error Error test strip The test strip is unusable or the test strip is not a CoaguChek XS PT test strip Error code chip The code chip is missing not properly inserted in the monitor or damaged 82 Error messages Solution Remove the test strip and repeat the test with a new or correct test strip Insert the code chip or remove it and re insert it 83 English Error messages Error messages after the code number was confirmed Display Description of error Error test strip The test strip is beyond its expiry date Error test strip The test strip is unusable 84 Error messages Solution First check whether the date setting is correct in the monitor If it is not set the correct date If the date is cor
32. of the code chip that is presently inserted Always compare the code number you see on the display with the number that is printed on the test strip container If the two numbers are identical confirm by pressing the M button see page 51 If the code numbers are not identical turn the monitor off and insert the correct code chip Discard the old code chip to prevent mix ups If the code chip is missing or incorrectly inserted Error and Code appear in the display please refer also to the chapter Error messages starting on page 75 25 English Monitor setup Monitor setup 26 Please note If you have not set the date after turning on for the first time or because the batteries were removed from the monitor for more than one minute you cannot perform a test In that case turning on the monitor takes you immediately to Set Mode where you must set the date and time Once you have set date and time the monitor automatically enters Test Mode Settings summary Monitor setup Setting Options Presetting Date format Day Month Year 31 12 00 31 12 00 Month Day Year 12 31 00 Year Month Day 00 12 31 Date 31 12 00 Time format 24 hour format 24h 24h 12 hour format 12h with a m p m Time 12 00 Unit Q INR Sec INR Beep tone On On Off Therapeutic range On Off only INR Off Set range INR Lower range 1 5 3 5 1 5 INR Upper range 2 5 4 5 2 5 INR Presetting means the sett
33. ownloads Error infrared interface Error during communication via the infrared interface caused by stray light 92 Error messages Solution Turn the monitor off and remove the batteries Wait at least one minute before re inserting the batteries in the battery compartment and then set the date and time as described starting on page 26 Repeat the test If the error message persists the monitor has a fault Please call your local customer support and service centre see page 100 Data downloads are performed via the infrared interface and can be dis turbed by bright surrounding light especially if the light shines directly into the infrared window on the monitor or at the receiving end e g on a computer Keep away from sources of stray light when downloading results 93 English Display information and symbols Display information and symbols These symbols may appear on the display They have the meanings shown Symbol Meaning C J Test strip without sample application area W Test strip with sample application area Apply sample User must wait until the monitor has com pleted an action C 24 hour time format h h 12 hour time format 4 4 2 Time between midnight and noon in 12 hour time format pm Time between noon and midnight in 12 hour time format 4Q Results are displayed as a Quick percentage value Se
34. rect turn the monitor off remove the code chip and test strip Use a test strip from a new lot of test strips and insert the code chip that came with the new lot Turn the monitor off remove the test strip and re insert it If the error mes sage appears again discard the unusable test strip and use a new one 85 English Error messages Display Description of error Error time exceeded The maximum allowed time of 120 seconds for applying blood has been exceeded Error messages during or after blood application Error blood application Error applying blood to the test strip 86 Error messages Solution Turn the monitor off remove the test strip and start a new test using the same test strip Turn the monitor off and remove the test strip Re read the instructions about applying blood starting on page 43 and repeat the test with a new test strip 87 English Error messages Display Description of error Error measurement Measurement error Error quality control The test strip failed the internal quality control check The test strip is unusable error Qc 88 Error messages Solution Turn the monitor off and remove the test strip Repeat the test with a new test strip Do not touch or remove the test strip when a test is in progress Turn the monitor off and remove the test strip Repeat the test with a new test strip In case the error occurs again call Roche
35. s 98 Product specifications Sample material Sample type Capillary whole blood or non anticoagulated venous whole blood Sample size At least 10 uL Interactions Refer to test strip package insert Storage and transport conditions Temperature range 25 C to 70 C Relative humidity 10 to 85 no condensation Disposal of the CoaguChek XS monitor During measurements the monitor itself may come into contact with blood Used monitors therefore carry a risk of infection Please dispose of your used monitor after removing the batteries and cleaning the moni tor according to the regulations applicable in your country For informa tion about correct disposal please contact your local council The monitor falls outside the scope of the European Directive 2002 96 EC Directive on waste electrical and electronic equipment WEEE For healthcare professionals Dispose of the monitor in line with your facility s procedures for dealing with potentially biohazardous waste 99 English Product specifications Information service If you have any further questions please contact your local customer support and service centre United Kingdom Roche Diagnostics Ltd Charles Avenue Burgess Hill RH15 9RY CoaguChek Careline 0808 100 7666 Canada Roche Diagnostics 201 Boulevard Armand Frappier Laval Qu bec H7V 4A2 Coagulation Info Line Telephone 1 877 4 COAGUCHEK Repairs Australi
36. t This highlights the fact that the result is out side your target range 17 Press the M button to toggle between OFF and On 18 Press the Set button to save the chosen setting and con tinue with the monitor setup If you have activated this display option On you are now able to enter the limits of your target range Consult your doctor about what target range is appropriate for you 38 19 20 21 22 Monitor setup Press the M button to set the lower limit symbolized by the down arrow within the range 1 5 3 5 INR Press the Set button to save the chosen lower limit and continue with the upper limit setting Now press the M button to set the upper limit symbol ized by the up arrow within the range 2 5 4 5 INR The selectable range will be at least 0 1 INR above the lower limit you have selected Press the Set button to save the chosen upper limit and close the monitor setup 39 English Monitor setup The monitor setup is now complete This display screen appears auto matically after you have com pleted the last setting and remains for a few seconds to indi cate that the setup procedure is now complete After that the monitor automati cally enters Test Mode 40 Monitor setup If you do not wish to perform a test at this point turn the monitor off You can exit the monitor setup procedure at any time e g if you have made an incorrect entry by
37. t is in progress W A check ofthe expiry date and lot information on the test strip W A quality control function is incorporated into the test strip Quality control and system checks using control test solutions that you may be familiar with from other systems are no longer required About this manual About this manual Manual format The layout of this User s Manual has been specially designed to help you locate the most important information quickly and easily Where illustra tions are used they always appear on the left side of the page with the accompanying explanation text on the right All instructions that require you to actively do something as well as especially important information appear on a blue background This symbol draws attention to the possible risk of sustaining Z X injury or of damaging your health 13 English About this manual Example This column contains an illustra This column states what you tion should do at this point 1 Press the On Off button Example This column contains an illustra tion of the display screen code mem 6 08 im a y 885888 error set so melee TCU Sec am INR E rm About this manual This column contains information linked to the display screen Each time you turn on the moni tor it runs a full display check briefly showing all the symbols that might be displayed To prevent reading errors check regularly th
38. test strip holder is in the correct position and properly attached Make sure that the cover is properly closed You will hear it snap into place 73 English Cleaning Cleaning by healthcare professionals Use 70 ethanol or isopropyl alcohol to clean the monitor We recom mend a mixture of 1 propanol 2 propanol and glutaraldehyde sold in some countries under the brand name Bacillol plus W Make sure the meter is off W Gently wipe the meters surface Wi Cotton buds wipes and cloths lightly moistened with disinfectant are all suitable for cleaning the meter W Allow areas you have wiped time to dry thoroughly W Remove any fluff or lint that may remain Refer to the section Cleaning page 71 for further information Observe the following precautions to avoid damaging the system W Make sure that no liquid enters the meter Do not spray anything onto the meter and do not immerse it in liquid Doing so may damage the meter s internal components and stop it from working properly W Observe the disinfection guidelines of your institution 74 Error messages Error messages Depending on the circumstances an error message may appear on the display of your monitor Your first step on receiving an error message should be to try the solution suggested for that error If the problem per sists please contact your local customer support and service centre see page 100 A complete list of display messages
39. test strip in as far as it will go A beep tone indi cates that the monitor has detected the test strip pro vided the beep tone is turned on in the settings Testing a capillary blood sample The code number of the code chip inserted in the monitor flashes in the display Make sure that this number is identical with the code number printed on the test strip container 9 Ifthe two numbers are identi cal confirm by pressing the M button The code number stops flashing If the code numbers are not identical remove the wrong code chip and insert the code chip that was supplied with the test strips you are using Using the wrong code chip can produce inaccurate results 51 English Testing a capillary blood sample 52 The hourglass symbol shows that the test strip is warming up When the warming up process is complete a further beep tone provided the beep tone is turned on indicates that you can now apply blood The blood drop symbol and the application area flash to indicate that the monitor is ready to per form the test and is waiting for blood to be applied At the same time a 120 second countdown begins You must apply the drop of blood to the test strip within this time otherwise you will receive an error message error and 000 where the result would normally be dis played Testing a capillary blood sample 10 Now lance the side of a fingertip with the lancing device
Download Pdf Manuals
Related Search