User`s Manual - La tienda de hiperuricemia.es
Contents
1. g HAW JH HH cc UH HL H 30 Avoid leaving the meter in extremely hot or cold place such as near a heat source or in an extremely hot or cold car Do not store or use the meter or test strips where they may be exposed to high humidity levels such as in a bathroom or kitchen Never immerse or hold the meter under running water DO NOT take the UASure Meter apart If there are technical problems or questions in use of the meter call the authorized dealer Chapter 7 Changing the Battery The UASure Blood Uric Acid Meter operates on one 3V lithium coin cell battery CR2032 When the LCD screen displays a flashing symbol of this indicates the battery is low and should be replaced as soon as possible NNOTE To save battery power the UASure Blood Uric Acid Meter will turn itself off after 3 minutes of non use All results stored in memory will be saved even if the meter shuts off automatically To replace the battery _ rm a mm Step 1 Open battery compartment cover on backside of the meter Step 2 Remove the old battery and replace with a new 3V Lithium coin cell battery CR2032 Step 3 Replace the battery compartment cover NIMPORTANT Discard used battery according to your local regulation 31 B uidit 0 OL LHHM B SNOLHUGHAINI 33USS Chapter 8 Message Interpretations amp What to Do If there is a problem with the way you are performing a test or if ther2. 1 About Your UASure Blood Uric Acid Monitoring System Contents Of Kit skl dalal k laka ka kea llke seek sya a kal n l s saa k d l daka k d d w k c n be b na ke la UASure Blood Uric Acid Meter ssssee mnm UASure Blood Uric Acid Test Strip E kk keke Adjustable Lancing Device and Lancets sseeeen UASure Uric Acid Control Solution optional cccceeeeeeeeeeeeteeeeeeees Before Testing Changing Unit of Measurement sssssssesseseseeeeenn enne Monitor Checker Test accio retinet itio ki denen suture cede dn H k no Ro EL R EWA WA ek anek edie Quality Control TESTING sacs eui ren tii rro eio rati e irit t d p Mte iuda Inserting Lancet Into Lancing Device sss Uric Acid Testing Coding the Meter E kk kk kek eene nennen nennt KK KA KK KAK kK KA nnn Performing a Blood Uric Acid Test i x 44y1 2 4 ki lalana kani A in n al n ka a kl kana z SINJINOD 40 1IHHI Understanding Your Blood Uric Acid Test Results Normal Blood Uric Acid Readings seruron aa 26 High Blood Uric Acid Readings eene 27 Frequency of Testing EE 27 Using Meter Memory simikan nin ea a eee 28 Caring for the Meter SINJINOD 40 11441 Cleaning the Meter cere ee aude een wereld tele 29 Storage and Precautions i k lt i sdklkl
3. Blood Uric Acid Test Strips come in a moisture proof light protected aluminum foil package Adjustable Lancing Device and Lancets Adjustable Cap Release Button Lancet Holder Protective Cover DET Lancet The UASure kit includes an adjustable 5 setting lancing device and sterile lancets for 2s c your comfort and protection You can adjust the puncture depth of your lancing device gt according to the thickness of your skin from the lightest 1 to the deepest 5 UASure Uric Acid Control Solution optional Standard uric acid concentration solution required to perform the Quality Control Testing in Chapter 2 p 13 to check for system accuracy practice test procedure and when using a new lot of UASure Blood Uric Acid Test Strips 10 Chapter 2 Before Testing Changing Unit of Measurement Your UASure Blood Uric Acid Meter can display test results in either mg dL or pmol L The factory setting is mg dL Consult your healthcare professional before changing the unit of measurement Material you will need Your UASure Blood Uric Acid Meter Step 1 Remove the battery cover at the backside of the Meter Step 2 Step 3 Step 4 Step 5 Remove the battery from the battery compartment Locate a switch on the left side in the battery compartment Slide the switch downwards for setup of measurement unit at mg dL or push the switch upwards for setup at pmol L Install the batte
4. found in each box of test strips Ti 38 Applied Product Standards IEC 61010 1 IEC 60601 1 EN 60601 1 EN 61010 1 EN 60601 1 2 EN 61326 39 Chapter 11 Supplies Part Number U3000 U3004 U3500 U3600 U3601 65235010001 65295710804 40 Product Name UASure Blood Uric Acid Monitoring System EZ LET J Lancet UASure Blood Uric Acid Monitoring System Lancing Device UASure Blood Uric Acid Control Solution UASure Blood Uric Acid Test Strips 25 s Bottle UASure Blood Uric Acid Test Strips 25 s Aluminum foil package Lancing Device Lancets 50 s Chapter 12 Symbols Used in this Manual c m ed EXP Expiration date use by last day of month 2 Q LOT Batch code m whe Temperature limitations Ti Consult instructions for use IVD In vitro diagnostic device Ez ZA Caution warning consult accompanying documents E5 Product code number pos Keep away from sunlight direct light Do not re use E Do not re use 41 Tr SE gt gt a J 1 MNHHUI Chapter 13 Product Warranty The UASure Blood Uric Acid Meter is guaranteed to be free of defects in workmanship and materials under normal use for a period of five 5 years from the date of purchase to the consumer The liability of Apex Biotechnology Corp is limited to repair or replacement and in no event shall Apex Biotechnology Corp be liable for any collateral or consequential damages or
5. loss Instruments subjected to misuse abuse neglect unauthorized repair or modification will be excluded from this warranty This guarantee specifically excludes expendables and consumables All warranty claims must be directed to the Apex Biotechnology Corp authorized dealer responsible for the sale of the system The warranty applies only to the original purchaser of the system 42 43
6. testing range of 18 C to 38 C 5 64 F to 100 F the screen will show and the meter is now ready for testing NIMPORTANT 1 Each time the UASure Blood Uric Acid Meter is used the current code will appear on the display screen when turned on Verify that the code displayed on screen matches the code number printed on the test strip package before testing The code needs to be set only once for each package of test strips The meter will memorize the code until it is changed Code number displayed on screen not matching the code number printed on the test strip package will create an inaccurate test result 2 If the screen shows Code meaning that the Meter is not coded or if the code number on the screen does not match the code number on the test strip package refer to Chapter 3 p 19 Coding the Meter 1 E NOTE If the temperature is outside of the operating range the meter needs to be moved to an area that is within its operating range of 18 C to 38 C s 64 F to 100 F and allow 10 to 15 minutes for it to reach the new temperature before use Measurement outside the temperature range will affect accuracy of test result 23 Si li fj ilu Hdl JU DIN 00014 HIJA INIL n u BMI Ol amp Hld WH BMI MJH JUN 00014 UNDA INISI Step 2 Wash hands with soap and warm water and dry thoroughly Step 3 Obtain a drop of blood using your lancing device refer to Chapter
7. the results you get in a laboratory The UASure Blood Uric Acid Monitoring System is intended for use outside the body in vitro diagnostic use and provides important information relating to blood Uric Acid control Your UASure Blood Uric Acid Monitoring System is designed for both individual self testing and for use by healthcare professionals Handicaped person and children way need assistance to use this device Contents of Kit The UASure kit package includes the following items g EE UASure Blood Uric Monitor Checker 1 Acid Test Strips 5 Code Card 1 Lancets 5 Adjustable Lancing Device 1 UA Sure Blood Uric Acid Meter 1 Uric Acid The kit contents may vary in some certain areas Contact the dealer if you find difference from the above User s Manual 1 Log Book 1 Test Strip insert for UASure Blood Uric Acid Test Strips 1 Carring Case 1 00014 ous UASure Blood Uric Acid Meter Display Screen Large easy to read window guides you through testing displaying results and error messages using simple words or symbols Push Button Recalls test results in the memory Refer to chapter 5 p 28 Using Meter Memory for details Til Press and hold to turn off meter Test Strip Holder Insertion site for test strips and monitor checker Located at the bottom front side of the meter When a test strip or the monitor checker is inserted the meter will power on automa
8. 2 p 17 Inserting Lancets into Lancing Device C Consult your healthcare professional for the proper technique of using a lancing device Step 4 Apply the blood to the yellow reaction zone on the top of the test strip When the reaction zone has filled completely the Meter will beep indicating that blood has been received by the test strip wore DO NOT proceed testing if the yellow window is not full of blood sample Insufficient blood sample may cause inaccurate test result DO NOT touch the target area of the test strip DO NOT smear the blood drop onto the target area DO NOT add or apply a second drop of blood This may cause false result 24 Step 5 The meter screen will display timing bars The bars will flash and gradually diminish for countdown Step 6 After the timing bars disappear approximately 30 seconds the screen will display test result Record the test result in the uric acid log book The test result is also automatically stored into the meter s memory refer to Chapter 5 p 28 Using Meter Memory 3 The meter will automatically turn off after the test strip is removed or after 3 minutes NCAUTION The used lancet and test strip are biohazard materials which should be disposed of properly to avoid injury or contamination udi BMI 03H JUN 0001A HAGA INLLSII 25 1 OJU JIN il IS1I 1 HIJA SNIONUISHIONA Had ved SINS Chapter 4 Understanding Your U
9. bi dise tisian en l lae de dee nennen 29 Changing the Battery illi alal llllnlu siselan nikere nennen nen dan be nnn 31 Message Interpretations amp What to do u E eke 32 Performance Evaluation ACCUTACY cani a adi za n sekla raa niya De Ei dert edere desea etse Poi Uem Zan av n e eee 35 Precision soie 6a k51 Ken eb k IM UM IEEE Lf PE ILLUM 36 10 Specifications uc m na neren le eoe Hec n re tek E RED Inde terc rauca 38 T1 SUP PMCS xcci e e e daneya khe n ken dD ey 4 5 Wed R Fen ierit tdt ettet an b VER N y 40 12 Symbols Used in this Manual seem 41 13 Product Warranty nu eL e ae eee KE H adel 42 SINTINO 40 TIGUL Chapter 1 About Your UASure Blood Uric Acid Monitoring System Thank you for choosing the UASure Blood Uric Acid Monitoring System to help you manage your blood uric acid levels All of the information that will be needed to use and maintain the UASure Blood Uric Acid Meter is included in this manual Read it carefully before using the system Utilizing Biosensor Technology your UASure Blood Uric Acid Monitoring System provides an easy and precise way of measuring the level of Uric Acid in capillary blood from the finger at specific points in time The results are plasma referenced which means that the results obtained from the UASure Blood Uric Acid Monitoring System is comparable to
10. cc Chapter 2 p 12 Monitor Checker Test il zx Step 2 After the display screen of the meter showing as ES the screen will then display the current code number being used Verify that code number on screen is the same with the code sg Se 25 Se 38 number printed on the alumium foil package of test strip NIMPORTANT 1 Do not use test strip that has expired Check the expiration date amp that is printed on the test strip package 15 2 Use each test strip immediately after removing it from the aluminum foil package 3 Do not use wet bent or scratched test strips 4 Keep away from direct sunlight and heat Store the test strip in a dry cool place 25 Step 3 Insert a brand new UASuree Blood Uric Acid Test Strip into the test strip holder of the meter The screen will show ctrl This will ensure the control results will not be stored into memory Step 4 When the screen shows apply a drop of UASure Blood Uric Acid Control Solution on top of the yellow reaction zone of the Test Strip Step 5 The display screen will show timing bars The bars will flash and gradually diminish for countdown Step 6 After the timing bars disappear the screen will show test result Compare the reading on the screen to the control range indicated on the test strip package The test result falling within the range means the meter and the test strip are working together properly Remove the test s
11. ding the meter ensures accurate test results when you perform a test A new code card is packaged along with each box of UASure Blood Uric Acid Test Strips Materials your will need A code card for the UASure Blood Uric Acid Test Strips A brand new UASure Blood Uric Acid Test Strip Your UASure Blood Uric Acid Meter NNOTE Make sure the UASure Blood Uric Acid Test Strips are not expired Check the test strip expiration date on the box and the test strip package The month printed refers to the end of the month 19 udi TAA rag JIH 00014 HOA SNIUSTE cc BMI MJH JUN 00014 HN Step 1 Locate the code card J in the package of test strip Step 2 Verify that the code number on the code card matches the code number on the test strip package Step 3 Insert the code card with the code number facing up firmly and completely into the code card port on the backside of the meter Step 4 Obtain a test strip SEE and insert the strip into the test strip holder located at front bottom of the meter The meter will turn on with a beep sound Step 5 A 4 digit code number will display on the meter screen Verify the code number on the screen with that on the code card and that on the test strip package All three sets of numbers should be the same NNOTE 1 The code card found in the test strip package is for use with that particular package only Test strips from different packages and other brands of tes
12. e is a problem with your UASure Blood Uric Acid Meter any of the following messages may appear on the meter screen If you have further questions after reviewing these messages call our authorized dealer Message Meaning What To Do code then The monitor has not been Code your Meter with a UASure the meter shuts coded with a code card Plus Code Card see Chapter 3 p 19 off in 3 seconds Coding the Meter The battery in the meter Replace the battery See the is running out of power instructions on Chapter 7 p 31 cyi Changing the Battery Ti 32 Message t LO t HI LO The temperature of the meter is below its operating range of lt 18 C lt 64 F The temperature of the meter is above its operating range of gt 38 C gt 100 F The blood uric acid result is lower than 3mg dL 179 pmol L What To Do The meter needs to be moved to an area that is within the meter s operating range 18 C to 38 C 64 F to 100 F The meter needs to be moved to an area that is within the meter s operating range 18 C to 38 C 64 F to 100 F f Repeat the test to confirm the test result If it reads LO again contact your healthcare professional 33 SIN d 8 Hild HH OO OL LUHM B SNOIHHHdHILNI 33US Message Meaning HI The blood uric acid result is higher than 20 mg dL 1190 pmol L 1 A used test strip is inserted SIN J 8 uidi 2 The meter does not function p
13. inical Site Studies Number of Samples 96 Range 3 7 mg dL to 19 2 mg dL Slope 0 9856 Intercept 0 32 mg dL Correlation Coefficient 0 9519 Precision Precision describes the variation between readings in the test system A test system with little variation is defined as precise A study was conducted with the UASure System using venous heparinized whole blood The whole blood will be spiked to provide samples at four different glucose concentrations 5 4 to 18 4 mg dL Multiple replicates n 20 were tested using multiple UASure Meter and one lot of UASure Blood Uric Acid Test Strips The following precision results were obtained 36 Individual Use Method Number of Readings Average mg dL S D mg dL C V 6 UiidEHi SNOHUITTUA EP 37 Chapter 10 Specifications Test Strips Test Range Blood Source Hematocrit Range Display Type Memory Dimension Weight Power Supply Operating Temperature Relative Humidity Storage Condition A NOTE UASure Blood Uric Acid Test Strips 3 20 mg dL 179 1190 pmol L Capillary whole blood 35 50 Large LCD screen 10 blood uric acid test result 100L x 58W x 21H mm 64g 1 x 3V Lithium coin cell battery CR2032 18 C to 38 C 64 F to 100 F Less than 85 4 C to 55 C 39 2 F to 131 F for meter 4 C to 30 C 39 2 F to 86 F for test strip For more information regarding the test strips see the test strip package insert
14. m gt c Ire m c c 13 14 NIMPORTANT The acceptable range for the control solution is listed on the package of test strips Use only the UASure Uric Acid Control Solution Always check the expiration date DO NOT use control solution if expired Newly opened bottle of control solution must be marked with the date opened discard any unused control solution three months after opening or expiration date amp Control solutions should be refrigerated after use DO NOT FREEZE When control solutions needs to be used again allow it to stand under room temperature at least 30 minutes before use If a control solution test is not within the expected range that is printed on the test strip package DO NOT use the system to test Repeat the test until a control solution test performs within the expected range If the results continue falling outside the expected range call the authorised dealer for service DO NOT touch the test area with the tip of the control solution bottle DO NOT apply a second drop of control solution to the test strip Replace the bottle cap on the control solution bottle immediately after use Materials you will need UASure Blood Uric Acid Control Solutions optional items contact our authorized dealer for purchasing information A brand new UASure Blood Uric Acid Test Strip Your UASure Blood Uric Acid Meter Step 1 Perform the Monitor Checker Test refer to
15. nstructions 27 SUINSAH ISAL OH JHN UNDA SNIONUISHIONA HH DH AMOWIW HIIN INISN LEH dHIJ Chapter 5 Using Meter Memory Your UASure Blood Uric Acid Meter automatically stores 10 test results When more than 10 test results have been performed the oldest result will be dropped from memory each time a new result is added When the test results are recalled from memory the most recent result is always displayed first To recall the results from memory Step 1 Press the push button to turn on your UASure Blood Uric Acid Meter The screen will display the latest test result stored in memory Step 2 Repeat pressing the push button for reviewing further test results in memory 28 Chapter 6 Caring for the Meter Cleaning the Meter Your UASure Blood Uric Acid Meter does not require special cleaning If the meter gets dirty use a moist NOT WET lint free cloth dampened with a mild detergent NNOTE 1 DO NOT get water inside the UASure Blood Uric Acid Meter Never immerse the meter or hold it under running water 2 DO NOT use glass cleaners or household cleaners on the meter 3 DO NOT try to clean the test strip holder ANStorage and Precautions Handle the meter with care severe shock such as dropping the meter could damage the electronics The meter and the test strips are designed to be used within the temperature ranges between 18 C to 38 C 64 F to 100 F wela 29 I LI Corm
16. ric Acid Test Results Uric acid in your body may fluctuate over time Your test results may also vary because of several factors Some of these factors include but are not limited to the following The food you eat Activities you perform Uric acid testing should be performed on fasting If you feel your test results do not reflect how you feel repeat the test If abnormally high readings persist contact your healthcare professional Normal Blood Uric Acid Readings Target blood uric acid levels are as follows Male 3 5 7 2 mg dL 208 428 pmol L Female 2 6 6 0 mg dL 155 357 pmol L 26 High Blood Uric Acid Readings If your test results are higher than 7 2 mg dL above 428 pmol L for men or 6 0 mg dL above 357 pmol L for women than you may have a medical condition known as hyperuricemia Hyperuricemia patients maybe at risk of kidney complications such as kidney stones and some may develop into a chronic form of arthritis known as gout Record your results in logbook The logbook assists in keeping a record of blood uric acid results along with information on food intake exercise and medication Frequency of Testing How often you need to test your blood uric acid will vary according to your age your diet the medication you are taking and your physical and emotional health Your healthcare professional will assist you in deciding when and how often you should test It is important that you follow their i
17. roperly questions and concerns O0 01 LUHM B SNOLILHUCHRINT 33US 34 What To Do Repeat the test to confirm the test result If it reads HI again contact your healthcare professional Remove and discard the used test strip amp then perform the Monitor Checker Test on p 12 i If the problem persists contact our authorized dealer for service If you are unable to correct the problem after following the What To Do procedures call our authorized dealer in your country or contact your healthcare professional with Chapter 9 Performance Evaluations The performance evaluation is determined in both clinical and laboratory settings Accuracy Accuracy describes how well the readings from a testing system meter and test strips agree with the readings from an accepted reference system laboratory analyzer A total of 24 venous blood samples collected with anticoagulants from different subjects were performed at 4 different uric acid concentrations range with UASure Meter and UASure Blood Uric Acid Test Strips The reference measurement was done on the EPAC 6140 Eppendorf Hamburg Germany included UA Plus 1661868 Kit ROCHE Postfach Switzerland The specimens ranged from 3 7 mg dL to 19 2 mg dL as measured by the EPAC 6140 comparative method Linear regression data from the combined studies compared well with results from the EPAC 6140 method 35 SNOLUNTUAI JIN b SNOLUNTUA JONG Cl
18. ry and replace the battery cover Monitor Checker Test The Monitor Checker Test will help ensure the electronics in your UASure Blood Uric Acid Meter is working properly This test should be done on a brand new meter or when the performance of the meter needs to be confirmed Materials you will need Monitor Checker included in kit Your UASure Blood Uric Acid Meter Step 1 Step 2 12 Insert the Monitor Checker R1 end into the test strip holder until you hear a beep When the meter display screen shows smiling face it means your meter is functioning properly and you can proceed to the next step If the display screen shows a sad face then repeat the testing procedure If continues to appear refer to Chapter 8 p 32 Message Interpretations amp What to do Ti Step 3 Repeat the testing procedures steps 1 through 2 on the R2 end of the Monitor Checker Quality Control Testing Perform Quality Control Testing when You first get your meter before performing a blood uric acid test You first begin to use a new package of UASure Blood Uric Acid Test Strips You suspect your UASure Blood Uric Acid meter and test strips are not working properly The blood uric acid results do not reflect how you feel When your test strips have been exposed to extreme temperatures N see UASure Blood Uric Acid Test Strip Insert for operation ranges Practice the test procedure Im
19. t strip may produce inaccurate results 2 Make sure the three sets of numbers from the meter display screen the code card and the test strip package match 20 3 Re coding needs to be done when a new package of test strip is opened for use or when changing battery The code number displayed on the meter should match the code number on the green code card and on the front of the test strip package Code Card cS rei c mm c M c c c c c c oo En e ss pares E E 3 8 8 S En s E amp 2 E 5 8 S 8 3 E amp 2 5 2 2 S Ed E 21 cc BMI MJH JUN 00014 HN 22 Performing a Blood Uric Acid Test Materials you will need A brand new UASure Blood Uric Acid Test Strip Your UASure Blood Uric Acid Meter NIMPORTANT 1 Do not use test strip that has expired Check the expiration date g that is printed on the test strip package and box 2 Use each test strip immediately after removing it from the aluminum package Do not use wet bent or scratched test strip 4 Keep away from direct sunlight and heat Store the test strip package in a dry cool place aX 09 Step 1 After you have performed the previous section Coding the Meter the meter will now self test the environment temperature If the temperature is below or above operation range the screen will display the tLO or tHI When the temperature is within the
20. tically When the test strip or the monitor checker is removed the meter will power off automatically Code Curd The code card programs the meter for a specific lot of test strips A new code card comes with each new package of test strips R1 Check R2 Check Z gt Monitor Checker Used to confirm that the UASure Blood Uric Acid Meter is functioning properly Refer to Chapter 2 p 12 Monitor Checker Test for details L3 er Code Card Port Insertion site for the code card Located at the top back of the meter UASure Wo A C n Manufactured by Apex Biotechnology Corp 4FNo 6 Innovation Rd 2 Science based Industrial Park Hsinchu Taiwan R O C Tel 886 3 5641952 Fax 886 3 5678302 Battery Compartment Located on the back of the meter Holds one 3V Lithium coin cell battery CR2032 Refer to Chapter 7 p 31 Changing the Battery Cli lt a eo zz Em c m c UASure Blood Uric Acid Test Strips Contact Points Test Strip Handle Reaction Zone Apply Blood Here Contact Points Sense the position and orientation of the test strip Test Strip Handle The only area to be touched when handling the test strip Reaction Zone The area where the blood sample or Control Solution is applied The UASure Blood Uric Acid Meter is designed specifically to detect uric acid in whole blood with the UASure Blood Uric Acid Test Strip only The UASure
21. trip Q 16 IMPORTANT If the test result is not within the expected range repeat the control solution testing If the results continue falling outside the expected range call our authorized dealer Inserting Lancets Into Lancing Device Materials you will need zE A sterile lancet Lancing device included in kit ae Step 1 Take out the lancing device and a new lancet Unscrew the adjustable cap of the lancing device and insert the lancet into the lancet holder and push down firmly until it is fully seated Step 2 Twist the protective cover off from the lancet then screw clockwise the adjustable cover back onto D the lancing device 17 Step 3 Adjust the puncture setting located on the adjustable cap for the puncture depth level 1 is the lightest and 5 is the deepest Step 4 With one hand holding the adjustable cap pull gt back the lancing device with your other hand until you hear a click sound The lancing device is now ready for blood sampling NIMPORTANT 1 Use only lancets that have been approved for use by your local health authority 2 Use a new sterile lancet every time you test to avoid cross contamination If alcohol wipes are used to cleanse the fingers make sure the area is dry before the blood sample is obtained 18 Chapter 3 Testing Your Blood Uric Acid Level Coding the Meter Before you can begin testing on your UASure Blood Uric Acid meter you must code the meter Co
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