STANDARD OPERATING PROCEDURE MULTICARE-IN
Contents
1. UNIVERSITY OF MALTA FACULTY OF MEDICINE amp SURGERY PHARMACY DEPARTMENT STANDARD OPERATING PROCEDURE Ref No SOP PD 226_01 MULTICARE IN Valid for 2 years from approval Table of Contents 1 Scope 2 Objective 3 Definitions 4 Responsibility 5 Procedure 5 1 Diagram 5 2 Set Up General Settings 5 3 Performing a Measurement 5 4 Performing a Control Test 5 5 Memory 5 6 Enabling Data Transfer to a Computer 5 7 Changing the Battery 5 8 Troubleshooting 5 9 Care and Maintenance 5 10 Flowcharts 6 Precautions 7 References 8 Appendices 9 Revision History Authorised Copy for Page eSeuneoecnuwust WwWwwnen we bi eet fee eet a ane S 16 Reading Copy Written by AM tng a Signature Date O Mrne Nl ron _ Francesta Wich m ciii foe tA vz vz va eview R ignature E Approved by mien M Azre ek Signature Date AA lt Ihfjizbz Page 1 of 16 UNIVERSITY OF MALTA FACULTY OF MEDICINE amp SURGERY PHARMACY DEPARTMENT Ref No SOP PD 226_01 STANDARD OPERATING PROCEDURE Valid for MULTICARE IN 2 years from approval 1 Scope This Standard Operating Procedure SOP applies to the staff and students using the multiCare In in the Pharmacy Practice Resource Unit PPRU at the Pharmacy Department University of Malta 2 Objective To describe the procedure for set up configu2. 5 2 4 Setting Date and Time 5 2 4 1 Use and keys to adjust the month and press power button to confirm 5 2 4 2 Use and keys to adjust the day and press power button to confirm 5 2 4 3 The monthjand day blink simultaneously Use and keys to select preferred visualisation of date configuration MM DD or DD MM and ptess power button to confirm 5 24 4 Use and keys to adjust the year and press power button to confirm 5 2 4 5 Use and keys to adjust the hour and press power button to confirm 5 2 4 6 Use and keys to adjust the minutes and press power button to confirm 5 2 4 7 The time blinks and 12h appears on the display Use and keys to select preferred visualisation of time configuration 12h or 24h and press power button to confirm Page 4 of 16 UNIVERSITY OF MALTA FACULTY OF MEDICINE amp SURGERY PHARMACY DEPARTMENT Ref No SOP PD 226_01 STANDARD OPERATING PROCEDURE Valid for MULTICARE IN 2 years from approval 5 3 5 2 5 Setting the Units 5 2 5 1 The unit of measurement mg dL blinks on the display Use and keys to select unit of measurement mg dL or mmol L and press power button key to confirm 5 2 6 Setting the Average of Results 5 2 6 1 0 starts blinking and days AVG appears on the diSplay Use and gt ke
3. MULTICARE IN 2 years from approval 5 3 8 Place the second drop on the reactive area saturating it completely The result will be displayed after a few seconds 5 3 9 Perform a control test if result is out of range too high Hi or too low Lo refer to section 5 4 5 3 10 Turn device Off when test is complete or device will shut down automatically after 1 5 minutes 5 4 Performing a Control Test 5 4 1 Follow section 5 3 using the control solution instead of ajblodd sample 5 4 2 Compare the result with the range shown oneth glabelyof the test strip container 5 5 Memory 5 5 1 Recalling Memory 5 5 1 1 5 5 1 2 5 5 1 3 5 5 1 4 Turn device On using power button Press and release and keys to enter Memory Mode and the average of th testiresultSywill be displayed Press And keys to display memory number if and keys are heldedown the device scrolls quickly and only memory positions aredisplayed Release and keys to display corresponding result 5 5 2 Deleting M mory 3 2A 5 5 22 5 5 2 3 Press power button and key for 1 second to delete one test result Press key for 5 seconds together with the power button to delete all test results Press power button to confirm 5 6 Enabling Data Transfer to a Computer 5 6 1 Install the software on the computer 5 6 2 Insert serial port of the cable in th
4. the strip before man for the drop blinking on the display The plastic support or the reading window are dirty from the meter without applying the drop of blood The strip that you are using dees not correspond to the Parameter of the data chip a strip is removed Page 8 of 16 Take a new strip insert it in the instrument and only after visualized blinking drop on the disphy apply the Blood on the strip Pull out the plastic support where you insert the als fof window using Water glasa win without soraich it Do not use parra or soap ert the Plastic support and repeat the test Switch off the meter by ON OFF button Insert the strip again and apply the blood on the strip without remove the sirip trea the strip holder Remove the data chip and use the one correspon te the sirip that you want to use and check that the sl feat symbol on the dis ia the same of the one sain on the strip UNIVERSITY OF MALTA FACULTY OF MEDICINE amp SURGERY PHARMACY DEPARTMENT Ref No SOP PD 226_01 STANDARD OPERATING PROCEDURE Valid for MULTICARE IN 2 years from approval The strip is inserted Insert the strip again and be upside down careful that the parameter symbol printed on the strip is on the upper part of the strip Dataschip error Remove the data chip and insert it Fia F still remains contact Multicare customer Service Beall The blood is not enough ne t
5. strip is inserted correctly Obtain a capillary blood sample from the fingertip 3uL for GLC and at least 10uL for CH and TGL discard first drop of blood Place the second drop of blood on the reactive area saturating it completely result will be displayed within a few seconds Perform a control test if result is out of range too high Hi or too low Lo refer to Section 5 4 Turn device Off when test is complete or device will shut down automatically after 1 5 minutes End Page 13 of 16 UNIVERSITY OF MALTA FACULTY OF MEDICINE amp SURGERY PHARMACY DEPARTMENT Ref No SOP PD 226_01 STANDARD OPERATING PROCEDURE Valid for MULTICARE IN 2 years from approval 5 10 3 Memory Turn the device On using power button Recalling Memory Press and release and keys to enter Memory Mode and average of the test results will be displayed Press and key to display memory number Release and keys to display corresponding result Deleting Memory Press power button and key for 1 second to delete one test result Press power button and key for 5 seconds to delete all of the test results i Press power button to confirm End Page 14 of 16 UNIVERSITY OF MALTA FACULTY OF MEDICINE amp SURGERY PHARMACY DEPARTMENT STANDARD OPERATING PROCEDURE Ref No SOP PD 226_01 MULTICARE IN Valid for
6. 2 years from approval 5 10 4 Enabling Data Transfer to a Computer Install software on computer Insert serial port of cable in the computer and the connector to the device Press and release power button PC will appear on the display and the data is transferred Turn device Off and remove cable End Page 15 of 16 UNIVERSITY OF MALTA FACULTY OF MEDICINE amp SURGERY PHARMACY DEPARTMENT Ref No SOP PD 226_01 STANDARD OPERATING PROCEDURE Valid for MULTICARE IN 2 years from approval 6 Precautions 6 1 Replace old code chip with new code chip each time a new container of strips is used 6 2 Check that the colour of the code chip and parameter symbol displayed on the device correspond to the parameter that needs to be measured 6 3 Keep test strips in their original container away from direct sunlight and humidity and at a temperature between 10 35 C 6 4 Close the test strip container immediately to avoid damage by4numidity and light 6 5 Do not use test strips after the expiry date 6 6 Dispose used test strips and other blood stained materials as biohazardous waste 6 7 Keep the control solution at room temperature 1Q 35 C 6 8 Do not use the control solutions to clean the device 6 9 Do not keep the device at temperdtures below 25 C or above 60 C 6 10 Turn the device off beforeremovingathe battery Reference Biochemical Systems Internati
7. Y DEPARTMENT STANDARD OPERATING PROCEDURE Ref No SOP PD 226_01 Valid for MULTICARE IN 2 years from approval Units Use the and keys to select the unit of measurement mg dL or mmol L and press power button to confirm Average of results Use the and keys to select 7 14 21 or 28 days and press power button to confirm Acoustic signal Use the or keys to select the acoustic signal on enabled or off disabled then confirm with power button Alarm Use and keys to select alarm number to be enabled 0 1 2 or 3 and power button again to select the hour and minutes alarm Press power button to exit Settings Mode End Page 12 of 16 UNIVERSITY OF MALTA FACULTY OF MEDICINE amp SURGERY PHARMACY DEPARTMENT Ref No SOP PD 226_01 STANDARD OPERATING PROCEDURE Valid for MULTICARE IN 2 years from approval 5 10 2 Performing a Measurement Insert code chip Turn device On code chip number parameter symbol GLC CH TGL and EC will show on the display Take a strip from the container and close container immediately Insert test strip in test strip slot with the slide indicating the printed initials of the parameter at the top Push test strip inwards until a click is heard a symbol showing a drop of blood appears on the display after about 1 5 seconds if the
8. e computer and the connector to the device Page 6 of 16 UNIVERSITY OF MALTA FACULTY OF MEDICINE amp SURGERY PHARMACY DEPARTMENT Ref No SOP PD 226_01 STANDARD OPERATING PROCEDURE Valid for MULTICARE IN 2 years from approval 5 6 3 5 6 4 Press and release the power button PC will appear on the display and data is transferred Turn device Off and remove the cable 5 7 Changing the Battery 5 7 1 5 7 2 5 7 3 5 7 4 Slide the battery compartment outwards Remove the batteries Place the new batteries 2 CR 2032 batteries with the positive side omtop Close the back cover until a click is heard Page 7 of 16 UNIVERSITY OF MALTA FACULTY OF MEDICINE amp SURGERY PHARMACY DEPARTMENT STANDARD OPERATING PROCEDURE Ref No SOP PD 226_01 Valid for 2 years from approval MULTICARE IN 5 8 Troubleshooting The temperature is lower Place the insirument in an area than 5 C 41 than 45 C 11 With temperature between S C 41 F and 45 C 173 F and wail for the instrument t equilibrate with the external py aeons before performing the measurement The strip is used of the Use a new strip to perform the reactive area le coloured measurement The sirip is not correctly Remove and insert the strip again inserted checking that it is plan on the plastic support of the instrument The blood was applied on
9. e of results acoustic signal and alarms Page 2 of 16 UNIVERSITY OF MALTA FACULTY OF MEDICINE amp SURGERY PHARMACY DEPARTMENT STANDARD OPERATING PROCEDURE Ref No SOP PD 226_01 MULTICARE IN Valid for 2 years from approval 4 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 5 Procedure 5 1 Diagram Ye eINAnawne Display Power button key key Test strip slot PC connector Cover Battery cover Code chip slot 10 Ejector Page 3 of 16 UNIVERSITY OF MALTA FACULTY OF MEDICINE amp SURGERY PHARMACY DEPARTMENT Ref No SOP PD 226_01 STANDARD OPERATING PROCEDURE Valid for MULTICARE IN 2 years from approval Code chip inserting Device mode Low battery warning Test results and messages Unit of measurement Test analytes Abnormal temperature warning Time Day and month 10 Alarm rawoeuser waa al bal Jat Ormai o Ne Oia O O32 20Pm P Ng OPNAR PPH 5 2 Set Up General Settings 5 2 1 Place batteries in the battery compartment 5 2 2 Turn device On using power button 5 2 3 Press and hold power button tofenter Settings Mode SET will appear in the display and the date will blink
10. he test and apply more The data chip is not Insert the date chip comesponding inserted to the strips that you want to use The result ts lower than H the result does not correspond the limit of that tothe personal sensations repeat parameter s also the test f LO is obtained again instruction for use ofthe contact your physician for strips additional information In the case of parameters Repeat the test with a big quantity cholesterol and of beod I LO is obtained again triglycerides where contact your physician for blood s oo to be additional information applied has to be abundant it is possible to obtain LO If the quantity of blood is under the bmit of enough volume Page 9 of 16 UNIVERSITY OF MALTA FACULTY OF MEDICINE amp SURGERY PHARMACY DEPARTMENT STANDARD OPERATING PROCEDURE Ref No SOP PD 226_01 Valid for MULTICARE IN 2 years from approval lirit of reading af that m sicia and rapant the t test in parameter a tal The batteries are almost Get new batteries flat It is possible to perform about 30 Measurements The batteries are flat The result is disco Check expiry date of the s nilinueus when the strip and use new strips to perform has expired measurements Blinking result is not saved in the memory VY 5 9 Care and Miintenance 7 rican Kaew 5 9 r Clean the Ae A at least once a week using an alcoh
11. ol swab 5 9 2 t soak the device in cleaning agents Va o 3 De 0 noyplace device under running water a s3 94 a the device to dry naturally Page 10 of 16 UNIVERSITY OF MALTA FACULTY OF MEDICINE amp SURGERY PHARMACY DEPARTMENT Ref No SOP PD 226_01 STANDARD OPERATING PROCEDURE Valid for MULTICARE IN 2 years from approval 5 10 Flowcharts 5 10 1 Set Up General Settings Turn device On using power button Press and hold power button to enter Settings Mode SET will appear in the display and date will blink Date month Select the month with the and keys and press power button to confirm Date day Select the day with the and keys and press power button to confirm Use the and keys to select preferred visualization of date configuration MM DD or DD MM and press power button to confirm Date year Select the year with the and keys and press power button to confirm Time hour Select the hour using the and keys and press power button to confirm Time minutes Select the minutes using the and keys and press power button to confirm Use the and keys to select preferred visualization of time configuration 12h or 24h and press power button to confirm t 2 Page 11 of 16 UNIVERSITY OF MALTA FACULTY OF MEDICINE amp SURGERY PHARMAC
12. onal multiCare In User Manual Arezzo Italy 2008 Appendices N amp Revision History Version Number Amendments Reasons for change ol Initial Release Page 16 of 16
13. ration operation recordingiand recalling of results quality control maintenance and troubleshooting of the multi are In 3 Definitions 3 1 3 2 3 3 3 4 3 5 3 63 Control solution Used to check the proper functioning of the device to ensure reliable results Checking with control solution should be carried out before device is used for the first time when starting a new bex of test strips when inserting a new battery following a cleaning procedure after accidentally dropping the device and when results do noticoincide with clinical symptoms The control solution must be used within 90 days from first opening The result obtained with the control solution must be deleted from memory not to interfere with the average test resulte EC Icon indicating that cod ichipyis inserted into the device Memory Mode multi are Yn_stores up to 500 test results for each parameter The results ncludingdatejand time will be saved in memory position 1 and results previously obtained will be saved in positions 2 3 and so on starting from the most recent multiCare In device Measures concentration of the parameters glucose GLE cholesterol CH and triglycerides TGL in whole blood using test Stfips specific to each parameter Each box of test strips has a unique code chip Reactive Area Circular white area where the blood sample is applied Settings Mode Allows setting of date and time units of measurements averag
14. ys to select 7 14 21 or 28 days and press power button to confirm 5 2 7 Setting the Acoustic Signal 5 2 7 1 BP appears on the display Use 4 and keys to select the acoustic signal on enabled or off disabled and pr ss power button key to confirm 5 2 8 Setting the Alarms 5 2 8 1 0 blinks on the diSplay Use and keys to select alarm number to be enabled 0 1 2 03 dndspfess power button to select hour and minutes alarm 5 2 9 Press power button to exit Settings Mode Performing a Measurement 5 3 1 Jnsert code chip 5 3 2 Switch the device On code chip number parameter symbol GLC CH TGL an EC will show on the display 5 3 3 Take afest strip from the container and close container immediately 5 3 4 Insert test strip in test strip slot with the side indicating the printed initials of the parameter at the top 5 3 5 Push test strip inwards until a click is heard a symbol showing a drop of blood appears after about 1 5 seconds if test strip is inserted correctly the blood drop can be applied with the test strip inserted in the device 5 3 6 Obtain a capillary blood sample from the fingertip 3uL for GLC and at least 10uL for CH and TGL 5 3 7 Discard the first drop of blood Page 5 of 16 UNIVERSITY OF MALTA FACULTY OF MEDICINE amp SURGERY PHARMACY DEPARTMENT Ref No STANDARD OPERATING PROCEDURE SOP PD 226_01 Valid for
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