For
Investigational
Use Only
NOVA MAX CREAT eGFR MONITORING SYSTEM
For Investigational Use Only
eGFR MeterIFU Manual PN64548A Personnal Meter.indd 1
12/20/21 12:19 PM
Страница 1: ...Use Only NOVA MAX CREAT eGFR MONITORING SYSTEM For Investigational Use Only eGFR MeterIFU Manual PN64548A Personnal Meter indd 1 eGFR MeterIFU Manual PN64548A Personnal Meter indd 1 12 20 21 12 19 PM...
Страница 2: ...eGFR MeterIFU Manual PN64548A Personnal Meter indd 2 eGFR MeterIFU Manual PN64548A Personnal Meter indd 2 12 20 21 12 19 PM 12 20 21 12 19 PM...
Страница 3: ...l distributor Supplies Web Site www novabiomedical com or contact your local distributor Nova Max is a RegisteredTrademark of Nova Biomedical Corporation Made in the U S A by Nova Biomedical Corporati...
Страница 4: ...eGFR MeterIFU Manual PN64548A Personnal Meter indd 4 eGFR MeterIFU Manual PN64548A Personnal Meter indd 4 12 20 21 12 19 PM 12 20 21 12 19 PM...
Страница 5: ...e requirements of Directive 98 79 EC IVDD Caution consultaccompanying documents Consult instructions for use Biological risk Use By Lot Number Only Prescription Use Only Electronic Waste Catalog numbe...
Страница 6: ...battery See the section on Battery Charging in this guide for details Perform all quality control checks recommended in this Instruc tions for Use Manual Notes Cautions and Warnings NOTES provide help...
Страница 7: ...eat eGFR Test Strip Information 10 Meter Components 11 Getting Started 12 Running Nova Max Creat eGFR Control Solution 21 Nova Max Creat eGFR Control Solution 21 Perform a Control Solution Test 21 Whe...
Страница 8: ...Personal Settings 43 Basic Upkeep 47 Battery Check 47 Charging the Battery 48 Cleaning and Disinfecting the Meter 49 Displays Meanings Actions 54 Appendix 62 Specifications 62 Ordering Information 64...
Страница 9: ...the Nova Max Creatinine and eGFR Test Strips and Nova Max Creatinine and eGFR Control Solutions and with single use auto disabling lancing devices It is not intended to diagnose a specific kidney dis...
Страница 10: ...ions The Nova Max Creat eGFR Test Strips give accurate results when the following limitations are observed Blood Useonlycapillarywholebloodobtainedfromthefingertip Do not use serum or plasma Donotuset...
Страница 11: ...rofessionals should be aware that all parts of the Nova Max Creat eGFR Monitoring System are considered potentially infectious and can potentially transmit blood borne pathogens between patients and h...
Страница 12: ...tandards Institute CLSI M29 A3 FDA Public Health Notification Use of Fingerstick Devices on More than One Person Poses Risk for Transmitting Bloodborne Pathogens Initial Communication 2010 http www fd...
Страница 13: ...must accept any interference received Including interference that may cause undesired operation Changes and Modifications not expressly approved by Nova Bio medical Corporation can void your authority...
Страница 14: ...antes 1 L appareil ne doit pas produire de brouillage 2 L appareil doit accepter tout brouillage radio lectrique subi m me si le brouillage est susceptible d en compromettre le fonctionnement Importan...
Страница 15: ...blood test result Test results are available in 30 seconds There is a memory for a minimum of 400 test results CAUTION The Meter should be handled with care Dropping rough handling etc may damage the...
Страница 16: ...ting instructions before operating the Meter 2 Retain the safety and operating instructions for future refer ence 3 Observe all warnings on the Meter and in the operating in structions 4 Follow all op...
Страница 17: ...Test Strips The Nova Max Creat eGFR Test Strips are designed for use with the Nova Max Creat eGFR Meter Use each Test Strip only once then discard DO NOT reapply blood to a Test Strip eGFR MeterIFU M...
Страница 18: ...store near heat or moisture StoretheTestStripsintheiroriginalvialonly donottransferstrips between vials After removing aTest Strip from the vial immediately replace the vial cap and close it tightly D...
Страница 19: ...trip inserted here eGFR Result ml min 1 73m2 Creat Result mg dL Power Button Charging Cable Connector Home Button Personal Settings Button eGFR MeterIFU Manual PN64548A Personnal Meter indd 11 eGFR Me...
Страница 20: ...inutes Once the battery is sufficiently charged the Meter will prompt you to configure it for use In addition to selecting the Lan guage Date and Time the Meter asks you to enter your Age Gender and A...
Страница 21: ...change the Date touch the current date to display the Set Date screen To change the Time touch the current time to display the Set Time screen When the correct Date and Time is displayed press Contin...
Страница 22: ...YYY DD MM YYYY orYYYY MM DD Set Date uses 3 scroll wheels for the month 1 12 day 1 31 and year 2021 2037 Scroll up or down to select the current month day and year Press Continue to save the date and...
Страница 23: ...d type AM PM or 24H The hour wheel will update 00 23 if 24H is selected Press Continue to save the time and return to the Verify Date and Time screen Press Back to discard any changes and return to th...
Страница 24: ...or press Back to return to the Verify Date and Time screen 6 From the Select Gender screen select Male or Female The selec tion will turn dark to confirm your choice Press Continue to advance to the S...
Страница 25: ...screen 8 Your selections for Date of Birth Gender and Ancestry are dis played If your selections are correct press Continue to advance to the Home screen Use the Back button to return to any of the fi...
Страница 26: ...t Battery Indicator Nova Max Creat eGFR Meter Screen Display Run QC Test Settings Icon History Icon eGFR MeterIFU Manual PN64548A Personnal Meter indd 18 eGFR MeterIFU Manual PN64548A Personnal Meter...
Страница 27: ...the Meter automatically turns itself off To manually turn off the display press the power button on the left side of the Meter briefly To turn the Meter off press and hold the power button down for 5...
Страница 28: ...ay the Verify Date Time screen Press Continue to display the Home screen If the Meter was in sleep mode the screen shown when the Meter entered sleep mode is displayed eGFR MeterIFU Manual PN64548A Pe...
Страница 29: ...the Meter and test strips are working properly Perform a Control Solution Test The Control Solution test confirms that the Meter and Test Strips are working correctly A Control Solution test is simil...
Страница 30: ...ults that fall within the range of results printed on the vial label of the Control being used If the Control Solution test result is outside the range is either higher or lower the Meter and Test Str...
Страница 31: ...ontrolSolutionvialonlyfor3monthsafterthefirstopen ing When you open a new vial of Control Solution count forward 3 months and write that date on the label of the Control Solution vial StoretheControlS...
Страница 32: ...d Contact Customer Service Testing a Control Solution 1 From the Home screen press Run QC Test The Select QC screen displays Select Run QC 1 or Run QC 2 2 Once the QC test is selected the Insert Test...
Страница 33: ...led Arrow flashes Blue Drop flashes 4 A countdown on the screen appears while the test is in prog ress The QC result is displayed on screen in 30 seconds and automatically stored in memory Running Nov...
Страница 34: ...is removed before the test starts or is not used for over 2 minutes the screen will go blank Out of range results may be caused by the following AnerrorinperformingtheControlSolutiontest retestandfol...
Страница 35: ...in use The Test Strip may have been damaged Retest using a new Test Strip The Meter may not be working properly NOTE If the Control Solution test result is outside the range is either higher or lower...
Страница 36: ...s of the Nova Max Creat eGFR Monitoring System are con sidered potentially infectious and can potentially transmit blood borne pathogens Only auto disabling single use 21 gauge lancing devices may be...
Страница 37: ...Edition ClinicalandLabora tory Standards Institute CLSI M29 A3 FDA Public Health Notification Use of Fingerstick Devices on More than One Person Poses Risk for Transmitting Bloodborne Pathogens Initia...
Страница 38: ...ss the Continue button to display the Insert Strip screen The Meter waits for you to insert a strip Once done the Meter transitions to the Apply Sample screen Testing a Blood Sample eGFR MeterIFU Manu...
Страница 39: ...6 Squeeze your finger to form a drop of blood Wipe away the first drop of blood then squeeze your finger again to form a second drop of blood 10 Touch the end of the Test Strip to the fresh blood drop...
Страница 40: ...results are displayed in 30 seconds and automatically stored in memory 13 Wash your hands thoroughly with soap and water after han dling the Meter Lancet or Test Strips eGFR MeterIFU Manual PN64548A P...
Страница 41: ...iohazard container Test Result Red 30 mL min 1 73m2 Orange 30 45 mL min 1 73m2 Yellow 45 60 mL min 1 73m2 Green 60 90 mL min 1 73m2 Green 60 90 mL min 1 73m2 NOTE The eGFR number indicates how well th...
Страница 42: ...FR value is shown in the table below National Kidney Foundation Estimated Glomeru lar Filtration Rate eGFR kidney org eGFR MeterIFU Manual PN64548A Personnal Meter indd 34 eGFR MeterIFU Manual PN64548...
Страница 43: ...g the Home screen The Home screen has a History button 1 Pressing this button displays the Result History screen Review Test Results in Memory eGFR MeterIFU Manual PN64548A Personnal Meter indd 35 eGF...
Страница 44: ...ght Arrow button for one of your result dates displays that result 3 Press the Personal Settings icon to open your Result Set tings screen Review Test Results in Memory eGFR MeterIFU Manual PN64548A P...
Страница 45: ...on Date 7 Select a QC result by date or a Creat result to display the Result screen 8 At the bottom left of the QC Result screen press the Back but ton to return the Result History screen or Home but...
Страница 46: ...t tone can be enabled for the user if desired and the Meter Software and Strip Reader version as well as the serial number of the Meter are displayed 1 To access the Meter settings menu from the Home...
Страница 47: ...e Set Date screen displays 7 Set Date uses 3 scroll wheels for the month 1 12 day 1 31 and year 2019 2038 Scroll up or down to select the current month day and year Press Continue to save the date and...
Страница 48: ...H The hour wheel will update 00 23 if 24H is selected Press Continue to save the time and return to the Date Time screen Press Back to discard any changes and return to the Date Time screen 10 Press B...
Страница 49: ...ng the speaker icon will toggle the sound between On or OFF Press Continue to save the Sound setting and return to the Meter Settings screen Press Back to discard any changes and return to the Meter S...
Страница 50: ...ersions screen displays 16 The Meter Software and Strip Reader version and the Meter s Serial Number are displayed 17 Press Back to return to the Meter Settings screen or press to return to the Home s...
Страница 51: ...s from the following screens 1 To access the Personal Settings menu from the Home screen press the Settings icon 4 The More screen displays press Personal Settings to display the Personal Settings scr...
Страница 52: ...ages 18 120 The Day scroll wheel adjusts de pending on how many days are in the month 7 Press the Continue button to save the Date of Birth and redisplay the Personal Settings screen Personal Setting...
Страница 53: ...r 9 Press the Continue button to save gender and redisplay the Personal Settings screen 10 Press Ancestry to display the Select Ancestry screen eGFR MeterIFU Manual PN64548A Personnal Meter indd 45 eG...
Страница 54: ...rsonal Settings screen press to return to the Home screen 13 The meter is now set up for your personal use Personal Settings eGFR MeterIFU Manual PN64548A Personnal Meter indd 46 eGFR MeterIFU Manual...
Страница 55: ...ttery status of the Meter Battery is Low The Meter shall display a yellow battery progress bar when the battery charge is 10 and 33 Continue with testing as usual If possible recharge the battery Batt...
Страница 56: ...creens while the Meter is plugged into anything through the USB Port The Meter prevents the user from using the device while it is plugged in This is just an icon not a represen tation for battery cha...
Страница 57: ...t eGFR Meter should be cleaned and disinfected weekly over the intended 3 year use life of the Meter The Nova eGFR cleaning and the disinfecting procedure was validated a total of 10 950 times by Nova...
Страница 58: ...nfecting means killing or preventing the growth of disease carrying microorganisms The Nova Max Creat eGFR Meter should be cleaned and disinfected weekly to minimize the risk of transmission of blood...
Страница 59: ...s Meter damage may include plastic housing cracks cloudiness or frosting of the display legibility or response issues with the keypad or battery compartment fluid leakage Signs of Meter performance d...
Страница 60: ...iscardtheusedwipeperStep4 2 Disinfect the Meter Remove another fresh GermicidalWipe from the canister Thoroughly wipe the top bottom left and right sides of the Meter avoiding the Test Stripport bywip...
Страница 61: ...air dry for an additional 1 minute NOTE If you must rewet the surface of the Meter use a new fresh wipe 4 Dispose of wipes Dispose of the used germicidal wipes in a standard waste container 5 Wash and...
Страница 62: ...Software Error The Meter detected an internal software error The Meter shall generate 3 short beeps Pressing the right arrow on any error will bring you back to the insert strip screen to run an othe...
Страница 63: ...hall generate 3 short beeps Pressing the right arrow on any error will bring you back to the insert strip screen to run an other strip Call Customer Service eGFR MeterIFU Manual PN64548A Personnal Met...
Страница 64: ...is outside the required temperature range 59 F to 104 F 15 C to 40 C Move the Meter to a warmer or cooler area and wait a few minutes Pressing the right arrow on any error will bring you back to the i...
Страница 65: ...ple Error The Meter detected a sample flow problem when applying a sample on the test strip The Meter shall generate 3 short beeps An insufficient sample vol ume was drawn into the Test Strip Repeat t...
Страница 66: ...or A problem was detected with the sample The Meter shall generate 3 short beeps An insufficient sample vol ume was drawn into the Test Strip Repeat the test with a new strip Pressing the right arrow...
Страница 67: ...and 0 30 7 00 for Creatinine mg dL These QC Result Screens will show if Creatinine values are out of the speci fied range for the Meter The current range is 0 30 7 00 for Creatinine mg dL Displays Me...
Страница 68: ...n What to Do Insert the Test Strip correctly with the Creat name and white tip facing up and out The battery is dead Recharge the battery Call Customer Service Displays Meanings Actions eGFR MeterIFU...
Страница 69: ...damaged The Meter may not be working properly Repeat the test with a new Test Strip Repeat the test with a new Test Strip Repeat the test with a new Test Strip After 3 attempts call Customer Service D...
Страница 70: ...lues Sample type Capillary whole blood from the fingertip eGFR Test range 15 90 mL min 1 73 m2 Limit of Detection Limit of Quantitation Length of Test 30 seconds Test Strip Volumes 1 2 L Appendix eGFR...
Страница 71: ...to 40 C Humidity 10 to 90 relative humidity Weight 3 17 oz 90 g Size 3 75 x 2 44 x 0 74 in 95 25 x 61 98 x 18 80 mm Meter data storage Minimum of 400 Results Appendix eGFR MeterIFU Manual PN64548A Pe...
Страница 72: ...ips Dual Pack 64154 Nova Max Creat eGFR Creatinine Control Solution Level 1 64148 Nova Max Creat eGFR Creatinine Control Solution Level 2 64149 PWR SUP SWI5 UNIV AC IN DC 5VO USB 62135 CABL ASSY USB A...
Страница 73: ...ranty This warranty is subject to the following exceptions and limitations 1 This warranty applies only to the original purchaser 2 This warranty does not apply to units which malfunction or are damag...
Страница 74: ...ranty service Contact Nova Biomedical or your local distributor Privacy Policy Nova Biomedical is committed to using your personal information responsibly and in compliance with the law You have our p...
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