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User`s Manual - Biochemical Systems International

1. 0 The control solution must be used within 90 days from first opening if the expiry date is valid When to carry out a working check up using the control solutions When suspecting a possible defect of the multiCare in instrument When suspecting the possibility of a malfunction or wrong measurement The result obtained with the control solutions has to be deleted by the memory of the meter in order to not interfere with the average calculation of the glycaemia 11 0 Pe O ES Oe gt 5 Memory functions recalling and deleting result from the memory The multiCare in meter stores up to 500 test results for all analytes letting you review them in order from the recent 1 to the oldest 500 If you insert the data chip of glucose into the meter you allow to recall only previous glucose test results It s all the same for other analytes 1 Press and release the or button in the STANDBY mode The meter will enter MEMORY mode and the average of test results is displayed amp amp 55 While pressing the or button memory number will be displayed If you hold down the or button the meter scrolls quickly and only memory positions are displayed A result is not shown until you release the button When release the or button the corresponding result will be displayed Repeat step 2 to se
2. Enabling data transfer to a computer All the test results stored in the multiCare in can be downloaded to a computer n Install the software according to the manufacturer s instructions 2 Insert the cable into the USB port of the computer and the jack of the cable into the meter 3 Press and release the power button PC will appear in the meter s display 4 Set up your computer software to receive information from the meter After the data has been transferred you can turn off the meter by pressing the power button and remove the jack cable from the port of the meter Care and maintenance For glucose measurement it is necessary a particular cleaning procedure only if blood or other material debris dust etc come into direct contact with the plastic support of the reader If so use only a wet cloth moistened by water or alcohol solution of 70 to clean the external parts of the instrument Since for cholesterol or triglycerides measurement the instrument uses an optical measuring method its components must be kept clean To clean the optical components lift the front cover and use a wet cloth on the glass surface of the optics After the cleaning dry the plastic support of the reader without scratching it For taking measurements on different people like in a hospital for example clean the instrument after every measurement with a solution 7096 alcohol before proceeding with the next measurement a
3. Switch off the meter by Power button Insert the strip again and aspirate the blood on the strip without remove the strip from the strip holder Remove the data chip and use the one corresponding to the strip that you want to use and check that the parameter symbol on the display is the same of the one printed on the strip messages Error messages Error Problem message Data chip error The blood is not enough inserted The result is lower than the limit of that parameter see also instruction for use of the strips The data chip is not E07 Remove the data chip and insert it again If E05 still remains contact Multicare customer Service Repeat the test and apply more blood Insert the data chip corresponding to the strips that you want to use If the result does not correspond to the personal sensations repeat the test applying a big drop of blood If LO is obtained again contact your physician for additional information 18 Error message Problem Error messages Solution hospital laboratory Get new batteries Replace the batteries before taking a measurement Check expiry date of the strips and use new strips to perform the measurements Blinking result is not saved in the memory Substituting the batteries The multiCare in instrument houses two lithium batteries 3V type CR 2032 If the battery icon is blinking the charge is low and the battery must be rep
4. choose between 12 or 24 hours SET SET 8 Press and release the power button to change the unit of measurement Press and release the or button to moria choose between mg dL and mmol L 9 Pressandrelease the power button to select how many days you want the average of results Press and release the or button up to reach the wished number of days 0 7 14 21 28 days 0 means that the meter will not show any average of the measurements Setting the acoustic signal 1 Switch onthe meter and press continuously the power button to enter in the SET mode Press and release the power button up to see bp fixed and On blinking on the display 2 Press the or button to activate or not the acoustic signal Setting the alarms SET Follow these instructions to set the alarms 1 Press and release the power button of the meter L Press the power button continuously to enter in the SET mode Press and release up to see the icon of the 4 alarm fixed 0 blinking 2 Press the or button to select the number of the alarm to be set 0 1 2 or 3 3 Press the power button again to select the hour and the minutes related to the alalrms that you are setting 4 You can exit by the SET mode in every moment by pressing continuously the power button for three seconds The alarms are not activated if they are set on 12 00 E or 0 00 ionem
5. The multiCare in meter uses a data chip that is inside the strips box It will be necessary to change the data chip in the following cases a before using a new strips box b when you want to change the analyte Measurement 1 Remove the data chip from the strips box 2 Insert the data chip in the proper space in the lateral part of the meter 3 Gently press the data chip up to the complete insertion 4 Press power button and check the three digit number is the same of the one printed on the strips vial 5 If the data chip is not inserted it is impossible to perform the measurement 6 Analytes GLC EL GLUCOSE ELECTRODES BLUE CH CHOLESTEROL GREEN TGL TRIGLYCERIDES YELLOW a How to obtain a drop of blood To perform a measurement with multiCare in System it is necessary to withdraw a drop of capillary blood using the following procedure Wash the hands with hot water to increase the blood circulation in the fingers to make easier the withdrawal of blood Dry well the hands Check that the finger to be pricked is completely dried Prepare the lancing device that is inside the multiCare in kit by inserting the sterile lancet Read carefully the instruction for use of the lancing device contained in the meter kit Use a new not damaged lancet for each prick and use the lancing device only on yourself Before the inserting verify that the lancets and the protection of the
6. the display 4 The meter will emit an acoustic signal and the result will be visualised on the display and automatically stored in the memory of the meter refers to the instruction for use that you are using to know the reading time 5 Press the ejector key to remove the strip that you used pointing the meter down for the low Warnings When the measuring is finished it is possible to turn OFF the multiCare in instrument The instrument will shut down automatically after 60 seconds if not used for other operations The measured value along with date and time will be saved in position 1 in the memory of the instrument The values previously measured will be saved in positions 2 3 etc starting from the most recent How to recall from the memory a measured value and how to erase memorized values is described on page 12 The strips and the used materials have to be properly disposed avoiding contamination The meter has to be disposed following the Electric and Electronic Waste law In a laboratory and in a hospital the procedures of biological safety must be followed when handling potentially infected material in particular when measurements are performed on different patients To avoid infections clean the instrument regularly and dispose of the used strips in a way that there is no risk of infections for other people The strips The correct use of the multiCare in strips is very important for o
7. btaining accurate results Therefore it is important to keep in mind the following The strips are sensitive to light and humidity keep the strips only in their original vial Protect the vial from direct sunlight and keep at a temperature between 5 and 30 41 86 F Usethe strips immediately after removing from the vial and close the vial immediately with its cap The strips must not be used after the expiry date When first opening write the date on the vial the strips must be used within 90 days after the vial has been opened Do not use strips that are damaged Carefully read the instructions contained in the package of strips Take measurements only with original multiCare in strips The Control Solutions Read carefully the instruction for use of the control solution that you want to use It is possible to check the working of the multiCare in instrument using the multiCare in control solutions The control solutions can be obtained as a separate accessory through specialized retailers The control solution is applied on the strip just like blood When testing is done with the control solution the obtained result must be within the interval as shown on the label of the strip s vial In this way it is possible to learn how to use the multiCare in properly and at the same time check if it is working Write the date of opening on the vial when the solution is opened for the first time
8. e in areas of specific voltage levels The appropriate legal provisions apply or the use of multiCare in The accuracy of the instrument should be checked after 3 years Please refer to local updated regulation 24 Customer Service Web wwwbiosys it multicare biosys it 0039 0575 984164 passi Biochemical Systems International Srl Arezzo Italy ED2008 REV02 EN multi Clare BIOCHEMICAL SYSTEMS INTERNATIONAL s r l Via G Ferraris 220 Arezzo Italia http www biosys it e e mail multicare biosys it WC
9. e the remaining stored results Keep the power button pressed and then press the button for 1 second to delete one test result stored in the meter Press button for 5 seconds together with the power button to delete all test results stored in the meter ticam cue Modification of settings l Press and release the power button to select the month Press and release the or button up to reach the correct month Press and release the power button to select the day Press and release the power button to change Press and release the power button to choose the date format Press and release the or button to choose between month day mm dd or day month dd mm Press and release the power button to change the year Press and release the or button up to reach the actual year The meter allows to change the year from 2007 to 2017 Press continuously the power button for 3 seconds The meter will enter in the SET mode and it will be possible to change the hour Press and release the or button up to reach the correct hour Press and release the power button to change the minutes Press and release the or button up to reach the correct minutes o0 pruri o0 7 Press and release the power button to change the hour format Press and release the or button to
10. l g gt Batch number Store at temperatures between 3V direct current and battery type C CE mark 0123 Do not dispose the instrument in the urban waste Perfom a separated collecting specific for Electric and Electronic X waste or give the instrument to the distributor when you buy a new or when you want to sobstitute it Please refere to local update regulation 23 Performance Measurement range Power source Dimensions Weight Display Temperature limits Humidity limits Memory capacity Interface for data processing Special requirements for electromagnetic radiation Hint for Healthcare Professionals Waste management disposal when the meter is unusable Performance 10 600 mg dl 0 6 33 3 mmol l glucose electrodes 130 400 mg dl 3 3 10 2 mmol l cholesterol 50 500 mg dl 0 56 5 6 mmol l triglycerides 2x3V lithium button cell type CR 2032 The battery can be used for approx 1 year with 3 measurements per day approx 1000 measur 97 mm length 49 mm height 20 5 mm width 65 g incl battery LCD 10 to 40 C 50 F to 104 F 0 to 90 relative humidity non condensing 500 measured values with time and date Connecting cable The CE mark on the device indicates that it complies with the requirements of the EC directives 89 336 EEC relating to electro magnetic compatibility 73 23 EEC for electrical equipment intended for us
11. laced before taking a measurement Sobstituting the batteries Always insert a new battery and not a used one Shut down the instrument before removing the battery Check out the new battery to see if it is of the right type before placing How to change the battery Open the sliding rear panel of the instrument 1 Remove the battery from the plastic holder 2 Place the new battery so that the type is readable The negative side of the battery must be at the top 3 Close the back cover until a click is heard Flat batteries can be disposed of through recycling centers Information on the conditions of warranty Biochemical Systems International Srl grants to the customer that the instrument will be free of material defects manufacturer handling for 3 years starting from the purchasing date During such period Biochemical Systems International Srl should replace the defected instrument with an equivalent version or the same model after verifying the defect Such warranty is subject to exception and limitation as described below The warranty is limited to the replacement due to defects in some parts and handling Instruments that present defects due to damages caused from improper use alteration negligence technical assistance performed from not authorised personnel accident abuse or by using strips which are different from multiCare in will not be replaced Biochemical Systems International Srl
12. lancets are intact Only a lancet protection intact can guarantee sterile lancet Store the protection of the lancet in order to use it to seal the lancet after use Application of the blood Read carefully the instruction for use of the strips that you want to use to perform the measurement l Press the Power button after inserted data chip The number that appears on the display has to match the one printed on the strips vial If it does not match contact Customer Service 2 Take a strip from the vial and insert it in the meter with the printed or coloured part on the upper side You will hear a click and the meter will emit an acoustic signal Procedure to test glucose 3a Perform the prick on the finger with the lancing device Apply a drop of blood on the part of the strips that comes outside the meter Let the strip aspirate the blood up to see the moving segments on the display If the volume is not sufficient the measurement does not start 7 Procedure to test cholesterol and triglycerides 3 b Sit down for one minute with the arm along the body Massage the finger to be pricked in order to increase the blood flow Prick the finger remove the first drop with a sterile gauze and gently press the finger to obtain a second drop Without touching and pressing the finger on the strip apply the drop on the white circular area of the strip that comes out of the meter Wait until moving segments will appear on
13. mode b Recall next stored results in the MEMORY mode c Change parameters displayed and decrease values in the SET mode d Reset the test results The meter automatically enters the TEST mode when a test strip is inserted PC Connector Transfers data from the meter to a computer Put your finger on this to let the battery cover slide I N i Data chip inserting D D Nea Meter s mode D Low battery warning y 0 Test results and messages EV e SEBS 4 c 9LeTGLCHEL TO temperature warning Unit of measurement Gad pm 3 danaa Day and month Test analytes 10 Alarm The mode The multiCare in has three modes You can check the present mode of the meter by seeing the top of display L Standby Mode Press and release the power button A strip shaped symbol will twinkle and the meter will display the data chip number time and date Memory Mode Press and release the or button in the standby mode The meter will display a MEM symbol on the top of the display Set Mode Press and release the power button in the standby mode Press again the power button for 3 seconds The meter will display a SET symbol on the top of the display 3 When switch on the meter check that the date and the hour are correct Coding the meter
14. multi USER S MANUAL In Vitro Diagnostic aid for self testing multi Introduction ssn The system A The meter The cens A The mode 1 2 s The measurement ssn Coding the meter How to obtain a drop of blood v Application of the blood Procedure to test glucose Procedure to test cholesterol and triglycerides 8 ees 9 The strips _ en mA 10 The control solutions Memory functions s 12 General settings ERE Modification of the settings s 18 Setting the acoustic 14 Setting the alarms m HU HN Enabling data transfer to a computer Ec Manteinance and Preservation conditions 16 Care and manteinance 16 Preservation and measuring conditions 16 Error messages cc T Substituting the batteries _ 20 Warranty A Symbols o o ooo 2 Performance 24 Table of contents A A A The system Thank you for choosing multiCare in system multiCare in is a new system useful for the monitoring of glucose cholesterol and triglycerides in the blood multiCare in has two different technologies amperometric with multiCare in in glucose electrodes strips reflectometric with multiCare in cholesterol and triglycerides strips Self monitoring of glucose cholesterol and triglycerides could be helpful but
15. nd Preservation conditions c cb mJ c 1 Preservation and measuring conditions To assure the accuracy of each measurement it is important to meet some conditions The measurement with multiCare in strips has to be performed between 10 and 40 C 50 104 F The multiCare in kit meter and strips has not to be stored at temperature lower than 5 C 41 F and over 30 C 86 F Error messages The temperature is out of the allowed range The strip is used or the reactive area is coloured The blood was applied on the strip before waiting for the drop blinking on the display The reading window is dirty The strip is removed from the meter without applying the drop of blood The strip that you are using does not correspond to the parameter of the data chip Error Problem message Place the instrument in an area with temperature between 10 50 F and 40 104 F and wait for the instrument to equilibrate with the external temperature before performing the measurement Use a new strip to perform the measurement Take a new strip insert it in the instrument and only after visualized blinking drop on the aspirate the blood on the strip Open the plastic cover where you insert the strip and clean the glass window using only water Dry the glass without scratch it Do not use solvents or soap Close the plastic counter and repeat the test
16. reserves the right to apply technical modifications to the instrument multiCare in without the obligation to insert such specification to those products already introduced in the market Any other warranty will be granted for this product unless the replacement option described above Every responsibility for special indirect or consequential damages is excluded 21 Cognome Vorname First name Prenom Nombre Nome Name Surname Nom Appelido Via Strasse Street Rue Calle CAP amp Luogo PLZ amp Ort Town amp Post code Localit C P amp Localidad Telefono Telefon Telephone T l phone Tel fono Telefax Fax Faxnummer E mail Numero di serie Seriennummer Serial number Num ro de s rie Num ro de serie Data di acquisto Kaufdatum Date of purchase Date d achat Fechade compra In conformit al D L gs 196 2003 sulla tutela dei dati prsonali la informiamo che le informazioni che vorr fornirci saranno trattate al fine di inviarle il materiale da lei richiesto ed elaborare elettronicamente con l adozione di misure idonee a garantire la sicurezza AUTORIZZO NON AUTORIZZO Data Datum Date Fecha Firma Unterschift Signature Spedire a Send to Envoyer Enviar a Senden zu Spett le BIOCHEMICAL SYSTEMS INTERNATIONAL s r l Via G Ferraris 220 52100 Arezzo Italia sca ED2008 REV01 IEDFS Symbols used on the packaging Follow instructions In Vitro Diagnosticum Use unti
17. the treatment to be applied has to be anyway agreed with the physician Information about multiCare in system line The multiCare in system line includes all is the necessary for the analytes check O prar 5 O i id multiCare in meter multiCare in strips lancing device Sterile lancets multiCare in control solutions multiCare in data manager software Read carefully the instruction for use inside the box of multiCare in strips that you want to use and read carefully the instruction for use of the lancing device that are inside the multiCare in meter box Glucose Electrodes Cholesterol Triglycerides Strip Strip Strip T TT l i Button Press this button to Button Press this button to Test Strip Slot Insert test strip here Cover Open this for cleaning Battery Cover Data chip Slot Insert the data chip Ejector Press to discharge the used strip Display Shows test results messages and results stored in memory Power Button Press this button to a Turn on the meter or turn off the meter b Enter the SET mode in the STANDBY mode C Go to the next step in the SET mode d Exit the SET mode and enter the STANDBY mode a Enter the MEMORY mode b Recall previous stored results in the MEMORY mode c Change parameters displayed and increase values in the SET mode a Enter the MEMORY

User`s Manual - Biochemical Systems International

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