Instructions of use for the PRIMA 2in1 in English
Contents
1. Delay starting the measurement after lancing Subject the instrument to sudden movements and shakes during a measurement Store the meter and test strips at extreme temperatures Store the instrument and strips under humid or damp conditions without suitable protection Failure to comply with the above notes may lead to inaccurate and false results 24 Further Information Ordering Information m Deseo REF Prima Cholesterol Test 25 test strips for PL301 Strips determining blood cholesterol 10 test strips PL302 Prima Triglycerides Test 25 test strips for PL303 Strips determining blood triglycerides 10 test strips PL304 Prima Cholesterol Con Control solution to PL308 trol Solution be used with the cholesterol test strips Prima Triglycerides Con Control solution to PL309 trol Solution be used with the tri glycrides test strips Prima 2 in 1 Meter PL300 multiparameter diagnostic 5 Cholesterol and device 5 Triglycerides strips Sterile lancets for Lancing 50 Sterile lancets PL313 device 100 Sterile lancets PL314 25 Product limitations Please read the package inserts for the test strips and control solutions for detailed information on product data and the respective test limitations Distributed by PRIMA Lab SA TecnoPolo Ticino 6928 Manno Switzerland WwwW primahometest com Made in Italy In vitro diagnostic medical device Read instructions before use2. Range temperature Expiry date 26 Reference number Batch code Manufacturer CE mark ED2014 LUGLIO EN
3. Are date and time correct If the measured values must be stored with time information enter the correct setting Does battery symbol appear If it appears only a few more measurements can be performed Replace batteries as soon as possible picture1 If the instrument has not been coded yet insert a respective Data chip into designed slot When the chip is entered correctly you will hear a beep picture2 3 e Verify if the code digit on the display corresponds to the code printed on the strip container 17 Now take the test strip from the test strip container Close the container immediately after re moving strip to protect the desiccants and remaining strips otherwise the test strips may become unusable before expiry date Liquids must not enter the test strip contai ner Hold the test strip with thumb and index finger so that the blood sample application area is facing upwards Insert the test strip into the designated strip slot From the printing on the reverse side of the strip the meter detects which test parameter is to be measured and which code is needed for the test strip If the code has not been entered via data chip yet an error message is displayed after inserting the test strip picture 4 After inserting the strip F Female on the left and M Male on the right will appear on the display Press the corresponding button for F or fo
4. both international units as mmol L used in Canada and Anglo American units as mg dL You can choose desirable units by setting the meter in the SET mode and pressing and buttons 3 mgldL mmol L What you need to perform a measurement Your PRIMA 2 in 1 meter Test strips for the desired measurement parameter with the related data chip Lancing Device Sterile Lancet User Manual Alcohol swap optional not provided with the kit Cotton ball or gauze not provided with the kit Log book to record results not provided with the kit Overview of the test strips and data chips The starter package of the PRIMA 2 in 1 home test includes a container with 5 test strips for measuring cholesterol and a container with 5 test strips for measuring triglycerides There are also containers with 25 strips available to purchase separately Test strips are chemically modified with enzymes The test strip changes color as it reacts to either total cholesterol or triglycerides in a drop of blood and the meter measures this color change Your total blood cholesterol or triglyce rides level is then shown on the display screen Each new container of the test strips is supplied with the data chip The chip provides the meter with important information on the specific properties of the respective test strip calibration data The chip is required before the strips are used 11 That means that you have to inser
5. needed massage your fingertip Hold the firmly against the side of the finger with the cap resting on the finger The harder it is pressed the deeper is the puncture Press the release button to prick After lancing yourself try obtaining a hanging drop of blood Always wipe off the first drop with a cotton ball and use the second drop for the testing The first drop of blood usually contains ex tracellular tissue fluids that may dilute your real capillary blood and cause er roneously low results After you finished with the measure ments unscrew the tip of the lancing device by turning it counter clock wise Push the lancet ejector forward with the thumb and simultaneously pull out the sliding barrel to dispose of the used lan cet in a proper container 16 Performing a measurement Get the test strip container for the required LLLLLLLLLLLL measurement manual Check the expiry date of the test strips Always use the strips before their expiry date has passed Make sure that Data chip belonging to these test strips is at hand see Coding the Instrument section of this NOTE Environmental influences e g air humidity and light on the test strips may damage test strips integrity and lead to false me asurements or error messages Do not remove the test strips from the strip container until immediately before performing a test e Turn on the meter Check the display before running the test
6. the meter and repeat the test after a few seconds E04 when the meter was coded for cholesterol test but a strip for triglyceri des was inserted for testing Solution remove the strip and repeat using a test strip matching the code for the test being attempted Alternatively re code the instrument for the respective test strip E05 error indicates data chip error Solution remove the chip and re insert properly If the E05 error remains call Customer care E06 error appears when insufficient blood sample was applied to the test strip application area Solution remove the used test strip and repeat the measurement applying a large drop of blood E07 error indicates that the data chip is not inserted Solution Insert a data chip for proper coding of the instrument LO error indicates that the result falls outside of the lower limit of the instru ment sensitivity e g too low values Solution Perform a control function check If control passes the check repe at the test applying a large drop of blood and ensuring that the first drop was wiped out and only the second drop was tested If the control check fails your instrument is not functioning properly Contact the Customer care Hl error appears when the result falls outside of the higher limit of the instru ment sensitivity e g too high values Solution Perform a control function check If control passes the check repe at the test If the repeated result is still h
7. ame time because batte ries with different capacities may impair the function of the meter 3 Close the battery compartment by sliding the rear cover back in until a click is heard 4 Power the instrument on to test the function of the new batteries When replacing batteries you have to insert new batteries within one minute to keep the set date and time If this time period is exceeded you have to re enter the date and time Measurement results including the related measure ment of date and time as well as all over instrument settings remain stored even when no batteries are inserted Please respect the environment and discard used batteries according to your local regulations and laws Do not throw batteries onto an open fire There is a risk of explosion Setting up the meter SET mode DATE MONTH and YEAR There are two formats dd mm and mm dd displayed in the lower right corner To set up the preferred format press and release the power button to enter SET mode until the date format is flashing Press or button to choose between the date formats To select month press and release on off button until the digit is flashing Press or to set the right month Similarly the date and the year are set by pressing power and buttons i 33 am nt J rt a am UL LI LU LI TIME There are also two formats for the setting time International format with 24h display A
8. ed a new lot of the test strip container When you want to check the performance of the meter and the test strip Memory The meter is capable of storing up to 500 test results and lets you review results in order from the most recent 1 to the oldest 500 When you insert an Data chip into the meter you can recall previous results While in the standby press and release and button to enter MEMORY mode The average result will be displayed If you press or button the memory number can be displayed If you hold down or the meterscrolls quickly and displays memory positions 20 A result corresponding to the memory position will be shown when you release the button To delete one of the stored results press the power button and button simultaneously for one second To clear all the test results stored continue to press power and buttons for five seconds Care and Maintenance A clean optical measuring system is a basic prere quisite for obtaining accurate and precise values for cholesterol and triglycerides Therefore regular cleans are highly recommended Always power off the meter before clea ning Use ordinary lint free cotton balls or gauze or cotton clean tissue or cloth Mild soap as well as 70 alcohol or iso propanol alcohol are suitable to moisten the cotton cloth to clean plastic surfaces Lift the front cover and gently clean glass surfaces o
9. f the optic with a dry gauze or cotton ball Clean plastic cover support of the meter with moistened and then dry gauze or cloth Do not use any disinfectant sprays or cloth cotton balls which are dripping wet as the liquid may penetrate and damage the instrument Error Messages In certain circumstances error messages may appear on your display E01 error means that the instrument or ambient temperature does not fall within the acceptable range for the selected test Solution move the instrument to an environment which has an appropriate temperature 18 35 C and wait for the meter to equilibrate before repea ting measurement Do not artificially heat or cool the meter by any means 21 E02 error can imply several things First the test strip is compromised because of coloration of the reactive area This might happen when a used or dirty strip is inserted or when a new strip was stored inappropriately It can also mean that the blood sample was applied too soon before the meter displayed flashing symbol of a blood drop Solution remove and discard the used strip open the plastic lid covering the test strip clot and clean plastic window with a slightly moistened with water gauze Take a new test strip insert it into the designated slot and apply a blood sample only after a blood symbol is displayed on the screen E03 error indicates that the strip was removed prematurely without applying a blood sample Solution power off
10. igh make a visit to your doctor If the control check fails your instrument is not functioning properly Contact the Customer care 22 Flashing results are indicative that the test strip is too old and may be expired Note that flashing results are not stored in the memory Battery is dying and needs replacement Performance specifications Operating conditions We Relative humidity 0 90 Temperature range for measurement 10 C 40 C Measurement range Cholesterol 3 3 10 2 mmol L 130 400 mg dL Triglycerides 0 56 5 6 mmol L 50 500 mg dL Memory capacity Up to 500 tests Battery 2x 3V button cell Type CR 2032 Number of measurements with new Approximately 1000 batteries 65 g battery inclusive Length 97 mm Width 20 5 mm Height 49 mm Display 23 Warranty The meter comes with three years of limited manufacturer warranty The warranty does not cover damages caused by improper usage and handling accident and or negligent care Important Notes Always Operate the instrument within the acceptable temperature range Place the instrument on a level surface or hold it steady in your hand e Make sure that all display elements are functioning during the self test Read the test strip inserts Keep the meter and the test strip container clean and tidy To get less variable results fast at least 10 hours before measurement Never Touch or remove the test strip during actual measurement
11. loodstream triglycerides are present as plasma lipids combined with cholesterol While cholesterol is used to build cell membranes and certain hormones triglycerides function is primarily to store energy All excessive calories that come from carbohydrates are converted to triglycerides and stored as fats to be used later as energy Although it s unclear how elevated levels of triglycerides are associated with hardening and thickening of the artery walls atherosclerosis which increa ses the risk of stroke heart attack and heart disease The condition is known as hypertriglyceridemia and aside from high calorie foods it can be caused by diabetes kidney disease or the specific genetic make up PRIMA 2 in 1 CHOLESTEROL and TRIGLYCERIDES system is intended for home use by people who have not previously had a lipid panel test done in order to give them an indication of whether one s cholesterol tri glyceride levels are high enough to visit their doctor for further advice and or to monitor lipid levels at home if one has already been told by the doctor that they are elevated The test is not intended for neonatal use since it hasn t been validated for that purpose It is intended to provide quantitative determina tion of total cholesterol and or triglycerides levels in the blood taken by finger stick It does not diagnose any medical condition and as with any test careful ly following the user instructions is a key for getting the most acc
12. nglo American format 12h display with am or pm To set up the preferred format press and release power button for 3 seconds to enter SET mode until the time format is flashing Press or button to choose between the time formats As with setting date and month you can set the right hour and minutes by pressing on off and or buttons Please note if you use the instrument without right set of time and date all measured results will be stored with correct time date information BEEPER After setting the time you can set the beeper by choosing ON or OFF It is recommended that you always leave the beeper enabled default setting If the beeper is enabled you will hear a beep in the following situations When the instrument detects that a test strip is inserted When the results appear on the display When an error occurs ALARM You can also enable an alarm on the meter if you wish to remind yourself about the testing You can program up to 3 alarms Note that the alarm does not function if it has been set on 12 00 or 00 00 time SET M ARN onem A AVERAGE You can set the meter to store an average of the test results performed during a particular period of time For example an average for 14 days as illustrated The principle of the setting is the same by pressing power button and and buttons 10 SET SET UNITS The meter allows displaying the test results in
13. nient tool for collecting capillary blood samples for tests which require one or two drops of blood As a more advanced lancing device it provides ultimate safety and comfort for obtaining blood samples An adjustable tip offers 5 levels of skin penetration for individual user s comfort and a lancet ejector enables the safe disposal of the used lancet How to obtain blood Preparation of the lancing device by inserting a new sterile lancet COMPONENTS mM Sliding Barrel Ejection System Depth Indicator Adjustable Tip Release Button 7 Unscrew the tip of the lancing devi M ce by turning it counter clockwise A while holding the base firmly PT s e N X Le a N k i z b 14 With two fingers pull out the lancet carrier and hold it in place While holding the lancet carrier insert a new sterile lancet into the bottom of lancet carrier Twist the cap of the lancet off Put the tip of the lancing device back on and turn it clockwise Hold the tip firmly in one hand then pull out the sliding barrel with the other hand This will cock the lancing device 15 SU ad T en y an wr a I F I z N sil k r J 2 a F zi T ral il d P zum A u X icc RE he s i L r F ral l j aqu s Es Fa Wwe aj L in Wash your hands with warm water En sure hands are warm and dry before lan cing If
14. od for levels of the two most common types of lipids cholesterol and triglycerides These lipids are frequently measured in tandem as part of the lipid panel to assess risk of heart disease Cholesterol is a soft waxy substance that serves as a precursor to bile acids steroids and vitamin D It is primarily synthesized in the liver and intestinal wall In normal circumstances the liver keeps a balance between absorption and excretion of cholesterol This balance however can be disturbed in cer tain types of diseases such as diabetes hypertension familiar hyperchole sterolemia as well as a result of leading an unhealthy lifestyle such as smo king alcohol abuse and unbalanced diet with excess of saturated fats and insufficient physical exercise Moreover stress hormonal contraceptives and pregnancy could lead to elevated levels of cholesterol A high cholesterol level is one of the major risk factors of heart disease The Canadian Cardiovascular Society recommends routine measurement of blood cholesterol for men over 40 and women over 45 years if there are no other risk factors If other risk factors are present testing is recommended for all those over 25 years old Triglycerides three molecules of fatty acids and a glycerol are the most common form of fat that humans digest To be absorbed these molecules are broken apart in the small intestine and afterwards are reassembled with cholesterol to form chylomicrons Therefore in the b
15. r M to select the gender After about two seconds A before meal on the left and P after meal on the right Will appear on the display Press the corresponding button for A or for P to select the letter The selected letter will remain two seconds on the display After that the code and the blinking drop will appear on the display indicating that the meter is ready to receive the blood picture5 The result will be stored in the memory as showed in the figure picture5 18 Lance the outer side of the fingertip with the lancing device and a sterile lancet to obtain a lar ge hanging drop of blood Wipe off the first drop with the cotton ball or gauze and use the second hanging drop of blood to apply to the test strip The meter displays a drop symbol on the scre en window indicating that the strip is inserted and ready for the blood sample Apply a large hanging drop of blood directly from the finger to the white sample application area of the strip Do not touch the application area with the finger The drop of blood must be applied to the test strip immediately after lancing the fingertip Blo od which is applied later may lead to inaccurate result For cholesterol and triglycerides testing it is cri tical to wipe away the first drop and immediately apply the second drop picture6 Read and record your result If the displayed result does not match your state of
16. t data chip when you want to change measuring parameter from cholesterol to triglycerides or vice versa Cholesterol CH Strip Cholesterol green Data chip Trigl riglycerides Triglycerides TGL Strip Data chi yellow E Do not forget to have the Data chip which is supplied with each new strip container at hand before performing the first measurement Each Data chip belongs to one particular test strip container or lot If possible store the test strip container together with the data chip in order to have the latter at hand 12 Coding the Meter 1 2 Remove Data chip from the container Insert the chip into Data chip slot Gently press the chip into the slot Press power onloff button If the instrument reads the chip information correctly a short beep confirms the successful coding if bee per is enabled The three digits code number should appear on the screen Check if this digit code is the same as on your strip container If you ve inserted the cholesterol chip then the strip sha ped symbol will be flashing with the CH symbol if triglycerides chip was inserted you should look for the TGL symbol If any problems occurs during coding the meter displays E05 error see Error Messages section of this manual If an error occurs repeat insertion of the chip after few seconds 13 Overview of the Lancing Device The PRIMA 2 in 1 test system includes the lancing device a conve
17. ter x J Temperature warnings Time gt s Day Month Year xs _ Alarm nmol L mg dL 6c D acu 29 Qaa pm gem 50 SOONODUOARWHD The Meter s Modes There are three modes in the meter STANDBY Mode Standby mode is the default mode that you enter every time you power on the meter by pressing power button The display in this mode should have a strip shaped symbol flashing along with the data chip number date and time clearly present MEMORY Mode While in the Standby mode press or button to enter Memory mode The meter will display MEM symbol on the top of the display and message code digit SET Mode SET SET While in the Standby mode press and relea se the power button Press the button again for 3 seconds The meter will display SET Pm symbol on the top of the display Operating the Meter Before using the instrument for the first time perform the following steps 1 Insert batteries 2 Set date time and beeper 3 Insert data chip can also be done just prior to performing the measurement Inserting batteries 1 Ensure that the instrument is turned off Open the battery compartment by sliding the rear cover 2 Insert two lithium batteries 3V type CR 2032 into compartment according to the illustrations Please note orientation of and sides of the battery Only use lithium 3V CR 2032 batteries Always replace all two batteries at the s
18. the health or seems to be unusually high or low check the me ter function using a new test strip and a control solution not provided in the starter package If this check confirms proper functioning of the in strument read again the proceeding instructions of this manual Perform another measurement using a new test strip If the new result also se ems to be not plausible consult your doctor 19 e When measurement is complete use the ejector key on the back of the meter to remove the used strip Press power button until the instrument po wers off Properly dispose of the used lancets and test strip according to your local laws and guide lines Clean the instrument if necessary see Care and Maintenance section of this manual pic ture 7 Quality Control Recommendations To ensure that meter is functioning properly you should consider using con trol solutions for a function check For each test parameter separate con trol solutions are available to purchase A function check is performed in the same way as a regular measurement except that control solutions are used instead of blood Make a habit of carrying out a function check in the following situations f you leave the test strips container opened for a long time or if the contai ner integrity was compromised If you drop the meter f you repeated a test and the result is still not plausible higher or lower than expected When you open
19. urate result Items in the Package One digital meter Five cholesterol strips a box of 5 or 25 strips is available to purchase separately Five triglyceride strips a box of 5 or 25 strips is available to purchase separately Two Data chips one for the cholesterol and another for triglyceride testing The chip contains lot specific information of the calibration curve for either cholesterol or triglycerides test One lancing device Ten sterile lancets One user s manual in both English and French One quick guide One carrying case Items not provided with the package Control solutions available to purchase separately Log book The Digital Meter Overview of the instrument 1 Display 2 Power Button 3 Button 4 Button 5 Test Strip Slot 6 PC Connector Slot 7 Cover Lid 8 Battery Compartment Lid 9 Data Chip Slot 10 Test Strip Ejector Rear DISPLAY AND SYMBOLS Every time the instrument is powered on you should check the display The instrument temporarily shows all the symbols that may appear in the display window Regularly check that all display elements are functioning correctly to prevent misinterpretations due to a defective display The symbols in the display have the following meanings Data chip inserted Meter s Modes Low battery warnings 2 Test results and other messages c JAVGMEMSET Unit of measurement w j w Test parame
20. w D R M A HOME TEST 2 N1 SELF TESTING KIT USER S MANUAL MULTIPARAMETER DIAGNOSTIC DEVICE y E O e e CHOLESTEROL ees TRIGLYCERIDES 41 0 91 605 1030 PL300 ENGLISH Thank you for buying the PRIMA 2 in 1 Cholesterol and Triglycerides home test system This manual contains step by step the instructions how to use the instrument and keep it ready to operate Please read this manual carefully before running the test Familiarize yourself with the required preparations and procedures before performing the first measurement Please also read the package inserts of the respective test strips If you have any questions please call Customer Care Summary What is the Prima 2 in 1 meter for 3 Items in the Package 4 The Digital Meter 5 Overview of the instrument 5 Display and symbols 6 Operating the Meter T Inserting batteries 8 Setting up the meter SET mode 8 What you need to perform a measurement 11 Overview of the test strips and data chips 11 Coding the Meter 13 Overview of the Lancing Device 14 How to obtain blood 14 Performing a measurement 17 Quality Control Recommendations 20 Memory 20 Care and Maintenance 21 Error Messages 21 Performance specifications 23 Warranty 24 Important Notes 24 Further Information 25 What is the Prima 2 in 1 system for PRIMA 2 in 1 Cholesterol and Triglycerides kit is the in vitro outside of the body system designed to self test the finger pricked blo
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