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Pooled creatinine data assessed using Linear Regression from all 3

clinical testing sites is shown below.

Capillary Whole Blood obtained from Finger-stick

Number of Samples:

Slope:

Y-intercept:

R squared (R2):

Appendix

eGFR MeterIFU Manual PRO PN64322.indd 64

1/14/22 3:42 PM

Содержание MAX PRO CREATININE eGFR

Страница 1: ...se Only NOVA MAX PRO CREATININE and eGFR METER SYSTEM GFR MeterIFU Manual PRO PN040921 indd 1 8 18 21 9 59 AM eGFR MeterIFU Manual PRO PN64322 indd 1 eGFR MeterIFU Manual PRO PN64322 indd 1 1 14 22 3...

Страница 2: ...eGFR MeterIFU Manual PRO PN64322 indd 2 eGFR MeterIFU Manual PRO PN64322 indd 2 1 14 22 3 42 PM 1 14 22 3 42 PM...

Страница 3: ...r contact your local distributor Supplies Web Site www novabiomedical com or contact your local distributor Nova Max Pro is aTrademark of Nova Biomedical Corporation Made in the U S A by Nova Biomedic...

Страница 4: ...Hessenring 13A Geb G 64546 M rfelden Walldorf Germany REP EC Nova Biomedical GmbH eGFR MeterIFU Manual PRO PN64322 indd 4 eGFR MeterIFU Manual PRO PN64322 indd 4 1 14 22 3 42 PM 1 14 22 3 42 PM...

Страница 5: ...ons for use Biological risk Use By Lot Number Only Prescription Use Only Electronic Waste Catalog number Temperature limitation Manufactured by Date of Manufacture For Near Patient Testing SN Serial N...

Страница 6: ...you need to charge the 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 Warn...

Страница 7: ...lay 15 Time Date Sound Language and Advanced Settings 16 Running Nova Max Pro Creat and eGFR Control Solution 27 Nova Max Pro Creat and eGFR Control Solution 27 Perform a Control Solution Test 28 When...

Страница 8: ...ry 50 Cleaning and Disinfecting the Meter 51 Displays Meanings Actions 56 Appendix 63 Specifications 60 Accuracy and Precision 62 Ordering Information 66 Warranty 67 Serious Incidents Adverse Advents...

Страница 9: ...sional healthcare settings The system should only be used with the Nova Max Pro Creat eGFR Creatinine Test Strips and Nova Max Pro Creat eGFR Creatinine Control Solutions and with single use auto disa...

Страница 10: ...FR System for testing neonates Testresultsarebestobtainedwhenusedwithinanoperating rela tive humidity of 10 to 90 non condensing Testing outside this range may cause inaccurate results Altitude There...

Страница 11: ...taminophen 20 0 mg dL Ascorbic acid 2 mg dL Bilirubin 20 mg dL Cholesterol 500 mg dL Creatinine 15 mg dL L Dopa 1 mg dL Dopamine 5 mg dL Glucose 600 mg dL Heparin 500 units dL Ibuprofen 48 mg dL D Mal...

Страница 12: ...ts andalcoholswabs mustbedisposed ofinaccordancewithlocalregulations Healthcareprofessionalsandothersmustweargloveswhile us ingthissystemonmultiplepatientsandshouldbeawarethat allproductsorobjectsthat...

Страница 13: ...lood borne pathogens between patients and healthcare professionals 3 The Nova Max Pro Creatinine and eGFR Meter System may only be utilized for testing on multiple patients when Standard Precautions a...

Страница 14: ...Microbiological and Biomedical Laboratories BMBL found at http www cdc gov biosafety publications bmbl5 Protection of Laboratory Workers From Occupationally Ac quired Infection Approved Guideline Four...

Страница 15: ...2 This device 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...

Страница 16: ...conditions suivantes 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 fonction...

Страница 17: ...e procedures of the Meter The following safety procedures must be followed 1 Read the safety and operating instructions before operating the Meter 2 Retain the safety and operating instructions for fu...

Страница 18: ...icable collection point for the recycling of electrical and electronic equipment Devices Accessories To ensure the product is disposed properly decontaminate the product according to the instructions...

Страница 19: ...designed for use with the Nova Max Pro Creat and eGFR Meter Use each Test Strip only once then discard DO NOT reapply blood to a Test Strip Important Nova Max Pro Creat and eGFR Test Strip Informatio...

Страница 20: ...diately replace the vial cap and close it tightly Do not use Test Strips beyond the expiration date printed on the package as this may cause inaccurate results Use an opened Test Strip vial only for 3...

Страница 21: ...eGFR 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 damag...

Страница 22: ...t eGFR Test Strip inserted here eGFR Result mL min 1 73 m2 Creat Result mg dL or mol L Patient Demographics Wake Sleep Button Charging Cable Connector Home Button eGFR MeterIFU Manual PRO PN64322 indd...

Страница 23: ...lows the user to navigate to all screens in the meter To go to the meter settings press the Settings icon Run Blood Test Battery Indicator Nova Max Pro Creat and eGFR Meter Screen Display Introduction...

Страница 24: ...d and the Meter Software and Strip Reader version as well as the serial number of the Meter are displayed 1 When the Meter is powered up the Meter will display the Nova Max Pro splash screen followed...

Страница 25: ...ter settings menu from the Home screen press the Settings icon 4 The Meter Settings screen is displayed 5 To set the current Date or Time press Date Time eGFR MeterIFU Manual PRO PN64322 indd 17 eGFR...

Страница 26: ...croll 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 return to the Date Time screen Press Back to...

Страница 27: ...0 59 and type AM PM or 24H The hour wheel will update 00 23 if 24H is se lected Press Continue to save the time and return to the Date Time screen Press Back to discard any changes and return to the...

Страница 28: ...Sound screen displays 3 Touching 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 cha...

Страница 29: ...ays 3 Select English German Spanish French Italian Portuguese Greek Dutch or Russian 4 Press Back to return to the Meter Settings screen or press to return to the Home screen Date Time Sound Language...

Страница 30: ...Settings screen press Versions 2 The Versions screen displays 3 The Meter Software and Strip Reader version and the Meter s Serial Number are displayed 4 Press Back to return to the Meter Settings sc...

Страница 31: ...ation Creatinine Unit of Measurement and Decimal Separator To access the Advanced settings from the Meter Settings screen press Advanced Date Time Sound Language and Advanced Settings eGFR MeterIFU Ma...

Страница 32: ...ark background 2 Press Continue to keep your selection and return to the Ad vanced screen or press Back to discard any changes and return to the Advanced screen Date Time Sound Language and Advanced S...

Страница 33: ...layed with a dark background 4 Press Continue to keep your selection and return to the Ad vanced screen or press Back to discard any changes and return to the Advanced screen Date Time Sound Language...

Страница 34: ...layed with a dark background 6 Press Continue to keep your selection and return to the Ad vanced screen or press Back to discard any changes and return to the Advanced screen Date Time Sound Language...

Страница 35: ...is a liquid control that contains a fixed amount of Creatinine UsethissolutiontotestthattheMeterandTestStripsareworking properly as a system If the Meter reading is within the range printed on the Con...

Страница 36: ...fore using the Nova Max Pro Creat and eGFR Meter for the first time As required by your institution s quality control policy or local regulatory requirements Ifapatienttesthasbeen repeatedandthebloodC...

Страница 37: ...s a system Important Information for Control Solution Use only Nova Max Pro Creat eGFR Control Solution Check the expiration date on the Control Solution vial Do not use Control Solution past the expi...

Страница 38: ...est results continue to fall outside the range printed on the Control Solution vial label TheNovaMaxProCreateGFRMetermaynotbeworkingproperly Do not use the Meter to test the patient s blood Contact Cu...

Страница 39: ...2 Once the QC test is selected the InsertTest Strip screen displays Insert a test strip 3 TheAddQC1 QC2 orQC3screendisplays Add theQCsolutionasshownonthedisplaytothestrip Running Nova Max Pro Creat eG...

Страница 40: ...me is remaining Once the countdown reaches 0 the meter displays the Results screen 5 The QC Result Screen displays Creatinine for the QC test At this point the test is finished Press the Home button t...

Страница 41: ...sults may be caused by the following You may not be doing the test properly Retest and follow the instructions carefully Thecontrolsolutionmayhaveexpiredorhavebeencon taminated Check the expiration da...

Страница 42: ...E If the Control Solution test result is outside the range is either higher or lower the Meter and Test Strip may not be working as a system Repeat the process using a new Test Strip Do not use the Me...

Страница 43: ...auto disabling single use lancing devices may be used with this system The Nova Max Pro Creatinine and eGFR Meter System may only be utilized for testing on multiple patients when Standard Precautions...

Страница 44: ...llyAcquired Infection Approved Guideline Fourth Edition Clinical and Laboratory Standards Institute CLSI M29 A4 FDA Public Health Notification Use of Fingerstick Devices on More than One Person Poses...

Страница 45: ...starts the process to run a patient test 2 The Enter Patient ID screen displays You can enter the ID by number only Testing a Blood Sample eGFR MeterIFU Manual PRO PN64322 indd 37 eGFR MeterIFU Manual...

Страница 46: ...Continue button to display the Enter Patient Age screen Enter the patient s age for this test from 18 130 years 5 Press the Continue button to display the Select Gender screen press Male or Female eGF...

Страница 47: ...unchecked on the initial startup for Se lect Gender and Select Ancestry screens This data is used to calculate eGFR and is stored with the result If you navigate back to this page through settings on...

Страница 48: ...massage finger with thumb toward the tip to stimulate blood flow 10 Use a single use disposable safety lancet to puncture the finger To reduce the risk of pre analytical error facilities should consi...

Страница 49: ...down timer begins Beeper sounds if enabled 13 A countdown on the screen appears while the test is in progress The eGFR and Creat results are available on screen in 30 seconds Testing a Blood Sample eG...

Страница 50: ...viewed later in the Result screens You can also click on the patient demographics icon which shows their settings for eGFR Press the Home button to return to the Home screen Testing a Blood Sample eG...

Страница 51: ...er Lancet or Test Strips NOTE Do not press the Test Strip directly against the skin Touch the Test Strip gently to the blood drop NOTE Discard used Lancets and Test Strips in a puncture proof con tain...

Страница 52: ...er flags calculated eGFR values into four categories Red Orange Yellow and Green The eGFR number indicates how well the kidneys are functioning As kidney disease progresses eGFR goes down Green 60 90...

Страница 53: ...t Result The Stages of Chronic Kidney Disease vs the eGFR value is shown in the table below eGFR MeterIFU Manual PRO PN64322 indd 45 eGFR MeterIFU Manual PRO PN64322 indd 45 1 14 22 3 42 PM 1 14 22 3...

Страница 54: ...splays the Patient History screen 2 The Result History screen displays a scroll wheel with all avail able results based on Date and Patient ID Pressing a Patient ID displays the patient s test results...

Страница 55: ...ack to the Patient History screen or press the Home button to return to the Home screen 4 To review QC History press the QC button at the bottom right of the Patient History screen Review Test Results...

Страница 56: ...a QC result by date or a Creat result to display the Result screen 7 At the bottom left of the QC Result screen press the Result but ton to return the Result History screen Review Test Results in Mem...

Страница 57: ...iew the battery status of the Meter Battery is Low The Meter displays a yellow battery status bar when the battery charge is 10 and 33 Continue with testing as usual If possible recharge the battery B...

Страница 58: ...charging screen is dis played if a test strip is inserted The remaining meter functions Patient and QC history and Meter Settings are fully acces sible while the meter is charging Charge the meter for...

Страница 59: ...eGFR Meter should be cleaned and disinfected after each patient use over the intended use life of the Meter The cleaning and the disinfecting procedure was validated a total of 10 950 times by Nova Bi...

Страница 60: ...and eGFR Meter should be cleaned and disinfected after each patient use to minimize the risk of transmission of blood borne pathogens between patients and healthcare professionals Healthcare professi...

Страница 61: ...eaning and disinfection may in rare cases damage the device s Meter damage may include plastic housing cracks cloudiness or frosting of the display legibility or response issues with the keypad or bat...

Страница 62: ...with a fresh GermicidalWipe DiscardtheusedwipeperStep4 2 Disinfect the Meter Remove another fresh GermicidalWipe from the canister Thoroughly wipe the top bottom left and right sides of the Meter avo...

Страница 63: ...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 sanitize hands Wash your hands thoroug...

Страница 64: ...ted operating temperature out of range The Meter shall generate 3 short beeps The Meter 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 a...

Страница 65: ...other strip Sample 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...

Страница 66: ...inserted upside down or not completely in 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...

Страница 67: ...tomatically turned off Test Strip may be 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...

Страница 68: ...L Plasmavalues Sample type Capillary whole blood from the fingertip eGFR Test range 15 90 mL min 1 73 m2 Limit of Detection 0 119 mg dL Limit of Quantitation 0 160 mg dL Length of Test 30 seconds Tes...

Страница 69: ...re 59 F to 104 F 15 C 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 400 Results Appendix eGFR MeterIFU Manual P...

Страница 70: ...ne and eGFR Meter with venous plasma creatinine and eGFR results measured on the IDMS traceable Seimens Healthineers Dimension RxL Chemistry System Seimens Healthineers Erlangen Germany The eGFR resul...

Страница 71: ...is assessment was 60 mL min 1 73m2 Subjects with an eGFR above 60 mL min 1 73m2 are considered to have normal kidney function Subjects below 60 mL min 1 73m2 are considered to have abnor mal kidney fu...

Страница 72: ...all 3 clinical testing sites is shown below Capillary Whole Blood obtained from Finger stick Number of Samples Slope Y intercept R squared R2 Appendix eGFR MeterIFU Manual PRO PN64322 indd 64 eGFR Met...

Страница 73: ...y Precision was as sessed using stabilized control solutions within 3 POC NPT settings at 3 different creatinine target levels over 20 days 4 measurements per day Typical Day to Day results are shown...

Страница 74: ...Nova Max Pro Creat eGFR Creatinine Control Solution Level 1 63941 Nova Max Pro Creat eGFR Creatinine Control Solution Level 2 63942 Nova Max Pro Creat eGFR Creat Linearity Level 1 2 and 3 63946 PWR SU...

Страница 75: ...stantial equivalent free of charge Limitations on Warranty This warranty is subject to the following exceptions and limitations 1 This warranty applies only to the original purchaser 2 This warranty d...

Страница 76: ...the warrantor s only obli gation under this warranty For warranty service Contact Nova Biomedical or your local distributor Privacy Policy Nova Biomedical is committed to using your personal informati...

Страница 77: ...events back to Nova Biomedical or Nova Biomedical s Authorized Representative as well as to their local Competent Authority as required Revision History PN 64322 Rev A Initial Release Appendix eGFR Me...

Страница 78: ...eGFR MeterIFU Manual PRO PN64322 indd 70 eGFR MeterIFU Manual PRO PN64322 indd 70 1 14 22 3 42 PM 1 14 22 3 42 PM...

Страница 79: ...eGFR MeterIFU Manual PRO PN64322 indd 71 eGFR MeterIFU Manual PRO PN64322 indd 71 1 14 22 3 42 PM 1 14 22 3 42 PM...

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