standard operating procedure coaguchek xs
Contents
1. 5 3 15 5 3 16 5 3 17 5 3 18 5 3 19 5 3 20 5 3 21 5 3 22 5 3 23 Repeatedly press the Set button while the result is being displayed until the desired unit of measurement is displayed if the current unit is not the desired one Result is automatically saved in memory If result is displayed in INR and an up too high or down too low arrow is also displayed this indicates that the value is outside the defined target range If c is displayed along with the result this indicates that the haematocrit value was very low or that the blood used was erroneously collected Repeat the measurement checking that hands are completely dry If gt or lt is displayed next to the result this indicates that the result is outside the valid measuring ranges of the test strips Remove the test strip from the test strip guide Press the On Off button to switch the device off Discard the used test strip in the sharps container Accessing Memory 5 3 22 1 Press the M button while the device is switched off 5 3 22 2 Wait until the display is stabilised and the most recent value is displayed 5 3 22 3 Repeatedly press the M button to scroll through the saved readings 5 3 22 4 Repeatedly press the Set button while viewing a result in memory if the displayed unit is not the desired one to temporarily change the unit in which the result is being displayed Erasing Memory 5 3 23 1 Press and hold the M butto2. UNIVERSITY OF MALTA FACULTY OF MEDICINE amp SURGERY Ref No PHARMACY DEPARTMENT SOP PD 211_01 STANDARD OPERATING PROCEDURE Valid for COAGUCHEK XS 2 years from approval Table of Contents Page 1 Scope 2 2 Objective 2 3 Definitions 2 4 Responsibility 3 5 Procedure 4 6 Precautions 15 7 References 15 8 Appendices 15 9 Revision History 15 Original Authorised Copy for Genn Muset Temhlggnarepae Bt jou FONWwso Wieth Signature Date fok D4 Oi 1 Written by Reviewed by Approved by Livan M Acze pal Signature Date x Page 1 of 16 UNIVERSITY OF MALTA FACULTY OF MEDICINE amp SURGERY PHARMACY DEPARTMENT Ref No SOP PD 211_01 STANDARD OPERATING PROCEDURE Valid for COAGUCHEK XS 2 years from approval 1 Scope This Standard Operating Procedure SOP applies to the staff and students using the CoaguChek XS in the Pharmacy Practice Resource Unit PPRU at the Pharmacy Department University of Malta 2 Objective To describe the procedure for the configuration operation maintenance and troubleshooting of the CoaguChek XS 3 Definitions 3 1 3 2 3 3 3 4 3 5 3 6 3 7 Battery Compartment F The area in which four 1 5V alkali manganese batteries type AAA are inserted in CoaguChek XS A point of care testing device used to quantitatively determine prothrombin t
3. 5 4 3 5 Hold the device upright with the test strip guide facing downwards 5 4 3 6 Clean the accessible white area with a cotton bud moistened in 70 alcohol 5 4 3 7 Wipe away any residual moisture with a dry cotton bud 5 4 3 8 Allow all wiped areas to dry for at least 10 minutes before performing a test 5 4 3 9 Re attach the test strip guide cover Page 7 of 16 UNIVERSITY OF MALTA FACULTY OF MEDICINE amp SURGERY PHARMACY DEPARTMENT Ref No STANDARD OPERATING PROCEDURE SOP PD 211_01 Valid for COAGUCHEK XS 2 years from approval 5 5 Troubleshooting Error Cause s Solution s error test strip Test strip was already Remove test strip symbol flashing inserted when device was switched on Test strip is unusable or not of the correct brand Remove test strip and repeat test with a new or correct one error temperature symbol flashing Device is too cold or too warm to measure correctly Switch device off and allow to stand for about 30 minutes at room temperature 15 C to 32 C error battery symbol flashing Battery level is too low to perform test Replace batteries with a new set error cover symbol Test strip guide cover is not Arrange test strip guide cover flashing closed properly accordingly error infrared Error during communication Keep away from sources of symbol flashing via an infrared interface stray ligh
4. E with the lettering CoaguChek XS PT facing upwards 5 3 6 Wait until a beep tone is heard to indicate that the device has detected the test stip 5 3 7 Check that the displayed code chip number corresponds to the code number printed on the label of the test strip container 5 3 8 Press the M button to confirm that the two values are identical 5 3 9 Wait until a beep tone is heard to indicate that test strip warm up time is complete 5 3 10 Wait until both the blood drop symbol and the symbol for the test strip application test area start flashing to indicate that the device is ready to perform a test A blood drop must now be applied to the test strip in 180 seconds 5 3 11 Apply the first drop of blood to the semicircular transparent sample application area of the test strip or else touch the blood drop against the side of the sample application area to draw the blood via capillary action 5 3 12 Hold the blood drop to the test strip until the flashing blood drop symbol disappears and a beep tone is heard 5 3 13 Wait until a tick appears next to QC to indicate that the test strip has passed the automatic quality control check of the meter 5 3 14 Wait until the result is displayed Page 5 of 16 FACULTY OF MEDICINE amp SURGERY UNIVERSITY OF MALTA PHARMACY DEPARTMENT Ref No STANDARD OPERATING PROCEDURE SOP PD 211_01 Valid for COAGUCHEK XS 2 years from approval
5. Device contaminated with blood Wipe exterior with a piece of cloth moistened in 70 alcohol Wipe away any residual moisture with a lint free cloth Press front edge of test strip guide cover upwards to remove it Wipe test strip guide cover with a piece of cloth moistened in 70 alcohol Hold device upright with test strip guide facing downwards Clean accessible white area with a cotton bud moistened in 70 alcohol Wipe away any residual moisture with a dry cotton bud Allow all wiped areas to dry for at least 10 minutes before performing a test Re attach test strip guide cover End Page 14 of 16 UNIVERSITY OF MALTA FACULTY OF MEDICINE amp SURGERY PHARMACY DEPARTMENT Ref No SOP PD 211_01 STANDARD OPERATING PROCEDURE Valid for COAGUCHEK XS 2 years from approval 6 Precautions 6 1 6 2 6 3 6 4 6 5 6 6 6 7 Operate the device in an ambient temperature of 15 C to 32 C Always close the test strip container as soon as a strip is removed since external influences such as humidity may deteriorate the test strips Do not store the device in damp and humid conditions Do not remove or insert a code chip while the meter is performing a test Do not use a different code chip from the one supplied with the test strips that are being used Always operate the device with the correct set time and date Do not wait for more than 15 seconds after lancing
6. G until it snaps into place Check that the displayed code chip number corresponds to the number on the label of the test strip container Press the M button to confirm code chip number If Error and Code are displayed the code chip is incorrectly inserted Press the Set button H if the device does not automatically enter into Set Mode Page 4 of 16 FACULTY OF MEDICINE amp SURGERY UNIVERSITY OF MALTA PHARMACY DEPARTMENT Ref No STANDARD OPERATING PROCEDURE SOP PD 211_01 Valid for COAGUCHEK XS 2 years from approval 5 3 5 2 9 Repeatedly press the Set button to scroll between the different configuration parameters available in the Set Mode see SOP PD 211_01 A1 5 2 10 Press the M button to change the setting that is currently flashing 5 2 11 Repeatedly press the M button until the desired setting is displayed 5 2 12 Press the Set button to confirm the selected setting 5 2 13 Press the On Off button to exit Set Mode at any time Operation 5 3 1 Place the device on a level stable surface or hold it in such a way as to be roughly in a horizontal position 5 3 2 Press the On Off button to switch the device On 5 3 3 Check that all of the display symbols are displayed properly since results may be misread if a segment of the display is missing 5 3 4 Wait until a flashing test strip symbol is displayed 5 3 5 Insert a test strip into the test strip guide
7. etely dry Remove test strip from test strip guide Press On Off button to switch off meter Page 12 of 16 UNIVERSITY OF MALTA FACULTY OF MEDICINE amp SURGERY PHARMACY DEPARTMENT Ref No SOP PD 211_01 STANDARD OPERATING PROCEDURE Valid for COAGUCHEK XS 2 years from approval Discard used test strip in sharps container Need to erase memory Need to access memory Press M button while device Press and hold M button while is switched off device is switched off Wait until display is stabilised and most recent value is displayed Repeatedly press M button to scroll through saved readings Repeatedly press Desired unit of Set button until measurement displayed desired unit is Need to exit Erase Mode displayed Press M button to confirm Wait until number of results in f is set to 0 and th Press On Off button PAMIROTY IS SSE 10 ORA util bars are displayed in centre of 3 display to indicate that entire memory has been erased End Page 13 of 16 UNIVERSITY OF MALTA FACULTY OF MEDICINE amp SURGERY PHARMACY DEPARTMENT Ref No SOP PD 211_01 STANDARD OPERATING PROCEDURE Valid for COAGUCHEK XS 2 years from approval 5 6 3 Maintenance Check that device is switched off before performing any maintenance procedures No Bars left in Replace all 4 batteries battery symbol ai Yes No
8. ime using capillary blood from a fingertip or untreated venous whole blood CoaguChek XS PT Test Strips Have a lyophilised reagent containing thromboplastin and a peptide substrate When a blood sample is applied to the test strip the thromboplastin activates coagulation leading to the formation of thrombin which goes on to cleave the peptide substrate generating an electrochemical signal The valid measuring ranges for the strips are 0 8 8 0 for INR 120 5 for Q quick percentage value and 9 6 96 for Sec seconds Code Chip Provides the device with important information about the test method the lot number and the expiry date of the test strips being used Each pack of test strips comes with a new code chip that should be inserted into the device when the new pack of strips is to be used Code Chip Slot G The area in which the code chip is inserted Display Screen A Displays the results and the information symbols Infrared Window I Used to transfer data stored in the device via an infrared interface Page 2 of 16 UNIVERSITY OF MALTA FACULTY OF MEDICINE amp SURGERY PHARMACY DEPARTMENT Ref No SOP PD 211_01 STANDARD OPERATING PROCEDURE Valid for COAGUCHEK XS 2 years from approval 3 8 M Button B The memory button used to recall results from memory and to change device settings Also used to confirm the code number displayed before each test 3 9 Memory Saves the la
9. n while the device is switched off 5 3 23 2 Press and hold the On Off button 5 3 23 3 Keep both buttons pressed for at least 5 seconds 5 3 23 4 Wait until mem and clr are displayed together with the number of results in memory on the upper right hand corner of the display 5 3 23 5 Press the On Off button to exit the Erase Mode without erasing the results 5 3 23 6 Press the M button to confirm 5 3 23 7 Wait until the displayed number of results in memory is set to O and are displayed in the Page 6 of 16 UNIVERSITY OF MALTA FACULTY OF MEDICINE amp SURGERY PHARMACY DEPARTMENT Ref No STANDARD OPERATING PROCEDURE SOP PD 211_01 Valid for COAGUCHEK XS 2 years from approval 5 4 Maintenance centre of the display to indicate that the entire memory has been erased 5 4 1 Check that the device is switched off before performing any maintenance procedures 5 4 2 Replace all 4 batteries if no bars are left in the battery symbol on the lower left hand corner of the display 5 4 3 Clean disinfect the device whenever it becomes contaminated with blood 5 4 3 1 Wipe the exterior with a piece of cloth moistened in 70 alcohol 5 4 3 2 Wipe away any residual moisture with a lint free cloth 5 4 3 3 Press the front edge of the test strip guide cover upwards to remove it 5 4 3 4 Wipe the test strip guide cover with a piece of cloth moistened in 70 alcohol
10. ollow the steps on correctly applying blood sample more carefully error 6 displayed Measurement error Switch device off and repeat test with a new test strip Do not touch or remove test strip when a test is in progress error 7 displayed Measurement error resulting from blood sample Switch device off and repeat test with a new test strip and blood taken from a new puncture site at the tip of another finger error 8 displayed Error during internal diagnostic test Switch device off and remove batteries Wait for at least 1 minute before re inserting them and reset the date and time Repeat test and if error message re appears contact supplier error 9 displayed Error during internal diagnostic test Switch device off and wait for at least 2 minutes Repeat test and if error message re appears contact supplier Page 9 of 16 UNIVERSITY OF MALTA FACULTY OF MEDICINE amp SURGERY PHARMACY DEPARTMENT Ref No SOP PD 211_01 STANDARD OPERATING PROCEDURE Valid for COAGUCHEK XS 2 years from approval 5 6 Flow Charts 5 6 1 Set Up Start Press On Off button to switch device On Check that number on code chip corresponds to number on label of test strip container Slide code chip into code chip slot G until it snaps into place Check that displayed code chip number corresponds to number on label of tes
11. t detects strip When pre heating of test strip is complete and sample needs to be applied When it detects sample When result is displayed _ When an error occurs Therapeutic Range with INR On or Off and x x To select between switching On or Off the option of displaying whether result is outside therapeutic range Set lower limit within the therapeutic range of 1 5 3 5 INR Set upper limit within the therapeutic range of 2 5 4 5 INR Page 16 of 16
12. t strip container Press M button to confirm code chip number Device o automatically Press Set button H entered into Set Mode Yes Repeatedly press Set button to scroll between different configuration Error and Code displayed Yes Remove and re insert code chip parameters in Set Mode see SOP PD 211_01 A1 Press M button to change setting that is currently flashing Repeatedly press M button until desired setting is displayed Press Set button to confirm Press On Off button to exit Set Mode at any time Page 10 of 16 UNIVERSITY OF MALTA FACULTY OF MEDICINE amp SURGERY PHARMACY DEPARTMENT Ref No SOP PD 211_01 STANDARD OPERATING PROCEDURE Valid for COAGUCHEK XS 2 years from approval 5 6 2 Operation Place device on level stable surface or hold it in such a way as to be roughly in a horizontal position Press On Off button to switch device On Check that all display symbols are displayed properly Wait until a flashing test strip symbol is displayed Insert test strip into test strip guide E with the lettering CoaguChek XS PT facing upwards Wait until beep tone is heard to indicate that device has detected test strip Check that displayed code chip corresponds to code number printed on label of test strip container Press M button to confirm that both values are identical Wait until beep tone is heard to indica
13. t while using the caused by stray light infrared interface error QC flashing Test strip failed internal quality control check Switch device off and remove test strip Repeat test with a new test strip error code flashing Code chip is missing not properly inserted or damaged Insert code chip or remove and re insert it error 000 displayed Maximum allowed time of 180 seconds for applying blood has been exceeded Switch device off remove test strip and start new test using the same test strip error 3 displayed Test strip is beyond its expiry date First check that date setting is correct If not arrange accordingly see SOP PD 211_01 A1 and repeat test If correct switch device Off remove code chip and repeat test with a test strip from a new lot together with the new code chip that is supplied with new test strips error 4 displayed Test strip is unusable Switch device off remove test strip and re insert it If error message re appears discard test strip and use a new one Page 8 of 16 UNIVERSITY OF MALTA FACULTY OF MEDICINE amp SURGERY PHARMACY DEPARTMENT Ref No STANDARD OPERATING PROCEDURE SOP PD 211_01 Valid for COAGUCHEK XS 2 years from approval Error Cause s Solution s error 5 displayed Blood not correctly applied to test strip Repeat test with a new test strip and f
14. te that test strip warm up time is complete Wait until both blood drop symbol and symbol for test strip application test area start flashing to indicate that device is ready to perform test A drop of blood must now be applied to the test strip in 180 seconds Page 11 of 16 UNIVERSITY OF MALTA FACULTY OF MEDICINE amp SURGERY PHARMACY DEPARTMENT Ref No SOP PD 211_01 STANDARD OPERATING PROCEDURE Valid for COAGUCHEK XS 2 years from approval Apply first drop of blood to application test area of strip or else touch blood drop against side of application test area to draw blood via capillary action Hold blood drop to test strip until flashing blood drop symbol disappears and a beep tone is heard Wait until a tick appears next to QC to indicate that test strip has passed automatic quality control check Wait until result is displayed Desired unit of Repeatedly press Set button measurement until desired unit of displayed measurement is displayed Result is automatically saved Result displayed in INR No lt or gt displayed next to result c displayed next to result Haematocrit value is very low or blood used was erroneously collected Result is outside valid measuring ranges of test strips Up or Down arrow displayed next to result Value is outside target range Repeat measurement checking that hands are compl
15. test 100 value readings in chronological order with the latest result first together with the relevant time and date 3 10 On Off Button C To turn the device On or Off 3 11 Set Button H To set the various monitor configuration parameters 3 12 Set Mode Allows the device to be set according to the user s preferences see SOP PD 211_01 A1 3 13 Test Strip Guide E The area in which the test strip is inserted 3 14 Test Strip Guide Cover D To be removed whenever the test strip guide requires cleaning Responsibility 4 1 The members of the Department of Pharmacy staff and students are responsible for following this SOP 4 2 The designated Laboratory Officer or Laboratory Assistant is responsible for ensuring that this SOP is followed Page 3 of 16 FACULTY OF MEDICINE amp SURGERY UNIVERSITY OF MALTA PHARMACY DEPARTMENT Ref No STANDARD OPERATING PROCEDURE SOP PD 211_01 Valid for COAGUCHEK XS 2 years from approval 5 Procedure 5 1 Diagram of CoaguChek XS 5 2 Configuration 5 2 5 2 2 5 2 3 5 2 4 5 2 5 5 2 6 5 2 7 5 2 8 Insert the batteries accordingly into the battery compartment F Press the On Off button to switch the device On Check that the number on the code chip to be inserted into the device corresponds to the number on the label of the test strip container Slide the code chip into the code chip slot
16. the fingertip before applying the blood to the test strip since longer times would falsify the result as the coagulation process would already have begun 7 References Roche Diagnostics CoaguChek XS Users Manual Mannheim Roche Diagnostics GmbH 2010 8 Appendices SOP PD 211_01 A1 Configuration Parameters Table 9 Revision History Version Number Amendments Reasons for change 01 Initial Release Page 15 of 16 UNIVERSITY OF MALTA FACULTY OF MEDICINE amp SURGERY PHARMACY DEPARTMENT Ref No STANDARD OPERATING PROCEDURE SOP PD 211_01 Valid for COAGUCHEK XS 2 years from approval SOP PD 211_01 A1 Configuration Parameters Table Setting Display Symbol Function Date Format xx xx xx To select between Day Month Year Month Day Year Year Month Day Date xx xx xx To enter the date in the following order Year Month Day Time Format 24h or 12hr To select between a 24 hour or a 12 hour time format with a m and p m Time xx xx To enter the time in the following order Hours and Minutes Unit INR Q or Sec To select the desired coagulation unit If INR is selected therapeutic target range can also be inputted Beep Tone On or Off To select between switching On or Off the beep tone signal Device will beep in the following situations When i
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