NOVA BIOMEDICAL MAX PRO CREATININE eGFR Instructions For Use Manual
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NOVA BIOMEDICAL MAX PRO CREATININE eGFR Instructions For Use Manual

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Investigational
Use Only
eGFR MeterIFU Manual PRO PN64322.indd 1
eGFR MeterIFU Manual PRO PN64322.indd 1
GFR MeterIFU Manual PRO PN040921.indd 1
NOVA MAX PRO CREATININE and eGFR
METER SYSTEM
1/14/22 3:42 PM
1/14/22 3:42 PM
8/18/21 9:59 AM

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Summary of Contents for NOVA BIOMEDICAL MAX PRO CREATININE eGFR

  • Page 1 NOVA MAX PRO CREATININE and eGFR METER SYSTEM Investigational Use Only eGFR MeterIFU Manual PRO PN64322.indd 1 eGFR MeterIFU Manual PRO PN64322.indd 1 1/14/22 3:42 PM 1/14/22 3:42 PM GFR MeterIFU Manual PRO PN040921.indd 1 8/18/21 9:59 AM...
  • Page 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...
  • Page 3 Supplies: Web Site: www.novabiomedical.com or contact your local distributor Nova Max Pro™ is a Trademark of Nova Biomedical Corporation Made in the U.S.A. by Nova Biomedical Corporation Copyright 2022 Nova Biomedical Corporation PN 64322 Rev. A 01/2022 eGFR MeterIFU Manual PRO PN64322.indd 3...
  • Page 4 Nova Biomedical GmbH Hessenring 13A Geb. G 64546 Mörfelden-Walldorf Germany 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...
  • Page 5 Symbols The following are symbols that are used in this manual, on insert sheets, and on the Meter. Catalog number In vitro diagnostic medical Temperature limitation device Manufactured by Authorized Representative in the European Community Date of Manufacture Caution For Near Patient Testing Consult instructions for use Serial Number Biological risk...
  • Page 6 Important Information! • Before you begin using your new Nova Max Pro Creat and eGFR Meter, please read all of the instructions provided in this Instruc- tions for Use Manual as well as the instructions provided in the Nova Max Pro Creat eGFR Creatinine Test Strips and the Nova Max Pro Creat eGFR Control Solutions.

  • Page 7: Table Of Contents

    Table of Contents Intended Use ........................1 Limitations ........................2 Interfering Substances ....................3 Important Safety Instructions ...................4 Blood-Borne Pathogens Safety ................5 FCC Notice ........................7 General Safety ......................9 Introduction ........................10 The Nova Max Pro Creat and eGFR Meter ............13 Meter Display ......................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...
  • Page 8 Table of Contents Testing a Blood Sample .....................35 Important Safety Instructions ................35 Test Result .........................44 Review Test Results in Memory .................46 Basic Upkeep .........................49 Battery Check ......................49 Charging the Battery .....................50 Cleaning and Disinfecting the Meter ..............51 Displays, Meanings, Actions ..................56 Appendix ........................63 Specifications ......................60 Accuracy and Precision..................62...

  • Page 9: Intended Use

    Intended Use The Nova Max Pro Creatinine and eGFR Meter System is intended for in vitro diagnostic use for the quantitative measurement of creatinine in capillary whole blood obtained from the fingertip for screening of kidney health by calculating Estimated Glo- merular Filtration Rate (eGFR).

  • Page 10: Limitations

    Limitations The Nova Max Pro Creat eGFR Creatinine Test Strips give accurate results when the following limitations are observed: • Blood – Use only capillary whole blood. Do not use serum or plasma. • Do not use the Nova Max Pro Creatinine and eGFR System for testing neonates.

  • Page 11: Interfering Substances

    Interfering Substances A study was conducted to examine Creatinine and eGFR measurement using the Nova Max Pro Creatinine and eGFR Meter System. The following substances were tested and determined to have no clinical interference: Tested Interfering Substances Tested Concentration Level Acetaminophen 20.0 mg/dL Ascorbic acid...

  • Page 12: Important Safety Instructions

    Important Safety Instructions WARNING: Blood samples and blood products are potential sources of hepatitis and other infectious agents. Handle all blood products with care. Wear gloves when performing measurements on another person. Items that are used to measure Creatinine and eGFR, i.e., Test Strips, lancets, and alcohol swabs, must be disposed of in accordance with local regulations.

  • Page 13: Blood-Borne Pathogens Safety

    Important Safety Instructions Blood-Borne Pathogens Safety 1. Healthcare professionals and others using this system should adhere to Standard Precautions when handling or using the Nova Max Pro Creatinine and eGFR Meter System. 2. Healthcare professionals should be aware that all parts of the Nova Max Pro Creatinine and eGFR Meter System are considered potentially infectious and can potentially transmit blood-borne pathogens between patients and healthcare professionals.
  • Page 14 Important Safety Instructions 4. Only auto-disabling, single-use lancing devices may be used with this system. 5. For more information, refer to the following references: “Guideline for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings 2007, ” http://www.cdc. gov/hicpac/2007ip/2007isolationprecautons.html. Biosafety in Microbiological and Biomedical Laboratories (BMBL) found at http://www.cdc.gov/biosafety/publications/bmbl5/.

  • Page 15: Fcc Notice

    Important Safety Instructions Federal Communications Commission (FCC) Notice FCC ID: QYY-61721 IC: 4562A-61721 This device complies with Part 15 of the FCC Rules: Operation is subject to the following conditions: 1. This device may not cause harmful interference, and 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 your authority to operate this equip-...
  • Page 16 Important Safety Instructions Radio Standards Specifications (RSS) Notice This device contains licence-exempt transmitter(s)/receiver(s) that comply with Innovation, Science and Economic Development Canada’s licence- exempt RSS(s). Operation is subject to the following two conditions: 1. This device may not cause interference. 2.

  • Page 17: General Safety

    Important Safety Instructions Reminder: Use of Fingerstick Devices on More than One Person Poses Risk for Transmitting Bloodborne Pathogens. ” (2010) http:// www.cdc.gov/injectionsafety/Fingerstick-DevicesBGM.html. General Safety Personnel operating this Meter must be proficient in the operating and maintenance procedures of the Meter, The following safety procedures must be followed.

  • Page 18: Introduction

    Important Safety Instructions Disposal of Used Batteries, IVD Devices, and Electronic Acces- sories for Customers in Europe : This symbol ( ) on the product label indicates that the product should not be treated as household waste. Batteries: To ensure the used battery is treated properly, remove the used battery from the product and hand over the used battery to the applicable collection point for the recycling of electrical and electronic equipment.
  • Page 19 Introduction Before Testing Before testing and to ensure accurate Creatinine and eGFR results, the patient must wash the hands and the test site; then thoroughly dry these areas. Test Strips The Nova Max Pro Creat eGFR Creatinine Test Strips are designed for use with the Nova Max Pro Creat and eGFR Meter.
  • Page 20 Introduction • Storage temperature for the Nova Max Pro Creat eGFR Test Strips: 35.6°F to 46.4°F (2°C to 8°C) • Do not freeze. • Do not store near heat or moisture. • Store the Test Strips in their original vial only: do not transfer strips between vials.

  • Page 21: The Nova Max Pro Creat And Egfr Meter

    Introduction The Nova Max Pro Creat and eGFR Meter The Meter is a hand-held testing device that measures Creatinine and eGFR levels in capillary whole blood obtained from the finger- tip. • A simple one-step process provides a Creatinine and eGFR blood test result.
  • Page 22 Introduction LCD Display eGFR Result mL/min/1.73 m Charging Cable Connector Wake/Sleep Button Creat Result mg/dL or µmol/L Home Button Patient Demographics Creat eGFR Test Strip inserted here Nova Max Pro Creat and eGFR Meter Components eGFR MeterIFU Manual PRO PN64322.indd 14 eGFR MeterIFU Manual PRO PN64322.indd 14 1/14/22 3:42 PM 1/14/22 3:42 PM...

  • Page 23: Meter Display

    Introduction Meter Display When you turn the Nova Max Pro Creat and eGFR Meter on, the home screen displays. The Home screen is the default screen for the meter. It allows the user to navigate to all screens in the meter. To go to the meter settings press the Settings icon Battery Indicator Run Blood Test...

  • Page 24: Time & Date, Sound, Language, And Advanced Settings

    Date & Time, Sound, Language, and Advanced Settings The Meter Settings menu provides a means of setting the date and time to match the local time zone or adjust for daylight savings. An alert 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.
  • Page 25 Date & Time, Sound, Language, and Advanced Settings 3. To access the Meter 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 MeterIFU Manual PRO PN64322.indd 17 1/14/22 3:42 PM...
  • Page 26 Date & Time, Sound, Language, and Advanced Settings 6. The Date & Time screen displays. 7. To set the current date, press Date. 8. The Set Date screen displays. 9. Set Date uses 3 scroll wheels for the month (1-12), day (1-31), and year (2019-2038).
  • Page 27 Date & Time, Sound, Language, and Advanced Settings Set TIME 1. To set the current time, from the Date & Time screen press Time. The Set Time screen dis- plays. 2. Set Time uses 3 scroll wheels for the hour (1- 12), minute (0-59), and type (AM, PM, or 24H).
  • Page 28 Date & Time, Sound, Language, and Advanced Settings Set Sound: On or Off 1. To enable or disable the alert sound, from the Meter Settings screen press Sound. 2. The Sound screen displays. 3. Touching the speaker icon will toggle the sound between On or OFF.
  • Page 29 Date & Time, Sound, Language, and Advanced Settings Select Language 1. To select a Language and Units, from the Meter Settings screen press Language. 2. The Language with Units screen displays. 3. Select English, German, Spanish, French, Italian, Portuguese, Greek, Dutch, or Russian. 4.
  • Page 30 Date & Time, Sound, Language, and Advanced Settings View Versions 1. To view the Meter’s Software version , Strip Reader version, and Serial Number, from the Meter 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.
  • Page 31 Date & Time, Sound, Language, and Advanced Settings Advanced Settings Advanced Settings allow the meter to be configured to use a selected eGFR Equation, Creatinine Unit of Measurement, and Decimal Separator. To access the Advanced settings, from the Meter Settings screen press Advanced.
  • Page 32 Date & Time, Sound, Language, and Advanced Settings 1. Select eGFR Equation, then select either CKD EPI (2009) or CKD EPI (2021). The selected equation will be displayed with a dark 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.
  • Page 33 Date & Time, Sound, Language, and Advanced Settings 3. Select Creat Units, then select the appropriate Creatinine unit of measure, either mg/dL or µmol/L. The selected equation will be displayed 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.
  • Page 34 Date & Time, Sound, Language, and Advanced Settings 5. Select Decimal Separator, then select the appropriate separa- tor, either a decimal point or comma. The selected separator will be displayed 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.

  • Page 35: Running Nova Max Pro Creat And Egfr Control Solution

    Running Nova Max Pro Creat eGFR Control Solution Nova Max Pro Creat eGFR Control Solution NOTE: Read the package insert sheets for Nova Max Pro Creat eGFR Control Solution for com plete instructions, indications, precautions, and limitations of the system. Nova Max Pro Creat eGFR Control Solution is a liquid control that contains a fixed amount of Creatinine.

  • Page 36: Perform A Control Solution Test

    Running Nova Max Pro Creat eGFR Control Solution Perform a Control Solution Test The Control Solution test confirms that the Meter and Test Strips are working correctly. A Control Solution test is similar to a blood test, except the Nova Max Pro Creat eGFR Control Solution is used instead of a blood sample.

  • Page 37: Important Information For Control Solution

    Running Nova Max Pro Creat eGFR Control Solution The Nova Max Pro Creat eGFR Control Solution should produce re- sults 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 Strip may not be working properly as a system.
  • Page 38 Running Nova Max Pro Creat eGFR Control Solution • Store the Control Solution tightly closed and refrigerated between 35.6°F and 46.4°F (2°C and 8°C). Do not freeze. • Shake the Control Solution well before using. If your Control Solution test results continue to fall outside the range printed on the Control Solution vial label: •...

  • Page 39: Testing A Control Solution

    Running Nova Max Pro Creat eGFR Control Solution Testing a Control Solution 1. From the Home screen, press Run QC Test. The Select QC screen displays. Select Run QC 1, Run QC 2, or QC 3. 2. Once the QC test is selected, the Insert Test Strip screen displays.
  • Page 40 Running Nova Max Pro Creat eGFR Control Solution 4. The countdown waits 30 seconds for the strip reader to process results. It displays the count down in the middle of a progress wheel that shows how much time is remaining. Once the countdown reaches 0, the meter displays the Results screen.
  • Page 41 Running Nova Max Pro Creat eGFR Control Solution NOTE: If the strip is removed before the test starts or is not used for over 2 minutes, the screen will go blank. NOTE: A quick beep sounds when sufficient Control Solution has been added to the Test Strip.
  • Page 42 • The Nova Max Pro Creat eGFR Meter may not be working properly. • Acceptable quality control ranges may differ at your institu tion from the ranges reported by Nova Biomedical. Follow your institu- tion’s guidelines for quality control results.

  • Page 43: Testing A Blood Sample

    Testing a Blood Sample Important Safety Instructions Standard Precautions should be adhered to when handling or us- ing the Nova Max Pro Creatinine and eGFR Meter System to reduce the risk of disease transmission. All parts of the Nova Max Pro Creatinine and eGFR Meter System are considered potentially infectious and can potentially transmit blood- borne pathogens between patients and healthcare professionals.
  • Page 44 Testing a Blood Sample For more information, refer to the following references: • “Guideline for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings 2007, ” http://www.cdc. gov/hicpac/2007ip/2007isolationprecautons.html. • Biosafety in Microbiological and Biomedical Laboratories (BMBL) found at http://www.cdc.gov/biosafety/publications/bmbl5/. “Protection of Laboratory Workers From Occupationally Acquired Infection ;...
  • Page 45 Testing a Blood Sample 1. From the Home screen, press Run Blood Test. This starts the process to run a patient test. 2. The Enter Patient ID screen displays. You can enter the ID by number only. eGFR MeterIFU Manual PRO PN64322.indd 37 eGFR MeterIFU Manual PRO PN64322.indd 37 1/14/22 3:42 PM 1/14/22 3:42 PM...
  • Page 46 Testing a Blood Sample 3. Enter Patient ID allows the patient's ID to be stored with their data. 4. Press the Continue button to display the Enter Patient Age screen. Enter the patient’s age for this test from 18-130 years. 5.
  • Page 47 Testing a Blood Sample 6. Press the Continue button to display the Select Ancestry screen: press Black or Other. NOTE: Both radio buttons are 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.
  • Page 48 Testing a Blood Sample 7. Press the Continue button to display the Insert Strip screen. The meter waits for you to insert a strip. Once the test strip is inserted the meter transitions to the Apply Sample screen. 8. Wash patient's hand with water then dry thoroughly. Alternatively, use alcohol pads to clean area;...
  • Page 49 Testing a Blood Sample 12. Touch the end of the Test Strip to the fresh blood drop until the Test Strip fills and the on-screen countdown timer begins. (Beeper sounds if enabled.) 13. A countdown on the screen appears while the test is in progress.
  • Page 50 Testing a Blood Sample 14. The Result Screen displays the eGFR and Creat results. At this point, the test is finished. The result can be viewed later in the Result screens. You can also click on the patient demographics icon which shows their settings for eGFR.
  • Page 51 Testing a Blood Sample 15. The result is automatically stored in memory. 16. Wash your hands thoroughly with soap and water after han- dling the Meter, Lancet, or Test Strips. NOTE: Do not press the Test Strip directly against the skin. Touch the Test Strip gently to the blood drop.

  • Page 52: Test Result

    Test Result Green Green Orange Yellow 60-90 >30 30-45 45-60 60>90 mL/min/1.73m mL/min/1.73m mL/min/1.73m mL/min/1.73m mL/min/1.73m NOTE: The meter 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.
  • Page 53 Test 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 3:42 PM...

  • Page 54: Review Test Results In Memory

    Review Test Results in Memory To review test results that are stored in memory, start with the Meter displaying the Home screen. The Home screen has a History button 1. Pressing this button displays the Patient History screen. 2. The Result History screen displays a scroll wheel with all avail- able results based on Date and Patient ID.
  • Page 55 Review Test Results in Memory 3. Press the Patient Settings icon to open the Patient demo- graphics screen for that patient , press the Back button to go back to the Patient History screen, or press the Home button to return to the Home screen.
  • Page 56 Review Test Results in Memory 5. The QC History screen displays a scroll wheel with all available QC results based on Date and Creatinine. 6. Select a QC result by date or a Creat result to display the Result screen. 7.

  • Page 57: Basic Upkeep

    Basic Upkeep Battery Check The Meter displays a green battery status bar when the battery charge is >33%. The status bar changes color from green to yellow to red to remind the user to recharge the battery. Test results are stored in non-volatile memory to prevent test result loss.

  • Page 58: Charging The Battery

    Basic Upkeep Charging the Battery The Meter is charged like a cell phone, using an external power supply connected to an electric outlet, and a charging cable connecting the power supply to the meter. The meter should be recharged when the battery icon changes color from green to yellow or red.

  • Page 59: Cleaning And Disinfecting The Meter

    Meter. The cleaning and the disinfecting procedure was validated a total of 10,950 times by Nova Biomedical to simulate a 3-year use-life of the Meter. The validation testing corresponded to cleaning and disinfecting 10 times a day for 3 years.
  • Page 60 Basic Upkeep Meter Cleaning and Disinfection Procedure Clean and disinfect after each patient use by following this protocol to help ensure effective cleaning and disinfection. Cleaning is not the same as disinfecting. Cleaning is intended to remove protein, visible blood, bodily fluids, and soils from the external surfaces. Disinfecting means killing or preventing the growth of disease- carrying microorganisms.
  • Page 61 Basic Upkeep IMPORTANT: Nova recommends cleaning and disinfecting the Meter with the following EPA Registered product - Clorox® Germicidal Wipes, EPA Registration #67619-12, or Super Sani-Cloth® Germicidal Disposable Wipes, EPA Registration #9480-4. Clorox Germicidal Wipes are available from the following suppliers: Amazon.com: http://www.amazon.com Clorox Healthcare: 1-800-234-7700 Office Depot: http://www.officedepot.com.
  • Page 62 Basic Upkeep Cleaning and Disinfecting the Meter NOTE: To properly clean and disinfect the Meter, steps 1 to 5 should be performed together before testing on each patient. 1. Clean the Meter. • Wipe the external surface of the Meter thoroughly with a fresh Germicidal Wipe.
  • Page 63 Basic Upkeep 3. Observe surface contact time. • Ensure the Meter surface stays wet for the recommended time and is allowed to air dry for an additional 1 minute. NOTE: If you must rewet the surface of the Meter, use a new, fresh wipe.

  • Page 64: Displays, Meanings, Actions

    Displays, Meanings, Actions This section addresses the messages that appear on your displays, what they mean, and what action you need to take. Display What it Means What to Do Temperature Error The Meter is outside the When the test strip was required temperature inserted, the Meter range 59°F to 104°F (15°C...
  • Page 65 Displays, Meanings, Actions Test Strip Error Replace with a new strip. The Meter detected Pressing the right arrow the inserted test strip is on any error will bring defective. The Meter shall you back to the insert generate 3 short beeps. strip screen to run an- other strip.
  • Page 66 Displays, Meanings, Actions Display What it Means What to Do The Meter • Test Strip inserted Insert the Test Strip does not upside down or not correctly with the Creat turn on after completely in. name and white tip facing inserting up and out.
  • Page 67 Displays, Meanings, Actions The Meter • Not enough blood Repeat the test with a does not sample new Test Strip. begin test • Sample applied after Repeat the test with a countdown Meter automatically new Test Strip. after apply- turned off ing a blood •...

  • Page 68: Specifications

    Appendix Specifications Test Measured Creatinine and eGFR Creat Methodology Enzyme, Amperometric Creat Blood Test Results 0.30-7.00 mg/dL or 27-619 µmol/L (Plasma values) Sample type Capillary whole blood from the fingertip eGFR Test range 15 - >90 mL/min/1.73 m Limit of Detection 0.119 mg/dL Limit of Quantitation 0.160 mg/dL...
  • Page 69 Appendix Battery Life (normal) 400 Tests Low Battery Life About 10 Tests Operating Ranges Temperature 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 eGFR MeterIFU Manual PRO PN64322.indd 61...

  • Page 70: Accuracy And Precision

    Appendix Accuracy and Precision Clinical Accuracy Clinical accuracy was assessed within 3 Point-of-Care/Near Patient Testing (POC/NPT) settings on normal subjects and subjects previously diagnosed with chronic kidney disease (CKD). The clinical study compared the creatinine and eGFR results obtained from capillary whole blood specimens obtained by finger-stick measured on the Nova Max Pro Creatinine and eGFR Meter with venous, plasma creatinine and eGFR results measured on the IDMS traceable, Seimens Healthineers Dimension RxL Chemistry System...

  • Page 71: Appendix

    Appendix kidney disease. Sensitivity is defined as the ability to correctly identify patients with a disease. Specificity is defined as the ability to correctly identify patients without a disease. The eGFR clinical cut-off level for normal/abnormal kidney function used for this assessment was 60 mL/min/1.73m2.
  • Page 72 Appendix 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): eGFR MeterIFU Manual PRO PN64322.indd 64 eGFR MeterIFU Manual PRO PN64322.indd 64 1/14/22 3:42 PM 1/14/22 3:42 PM...
  • Page 73 Appendix Clinical Precision Within-run precision was assessed using venous whole blood col- lected in lithium heparin within 3 POC/NPT settings at 3 different creatinine target levels. Typical creatinine within-run precision per- formance is shown in Table 1 below. Day-to-Day 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.

  • Page 74: Ordering Information

    Appendix Ordering Information Supplies and parts for the Nova Max Pro Creatinine and eGFR Meter System are available from Nova Biomedical. DESCRIPTION .................Part # Nova Max Pro Creat eGFR Creatinine Test Strips......63983 Nova Max Pro Creat eGFR Creatinine Control Solution Level 1 ... 63941 Nova Max Pro Creat eGFR Creatinine Control Solution Level 2 ...

  • Page 75: Warranty

    Appendix Warranty Your Nova Max Pro Creat and eGFR Meter is warranted to be free of material and workmanship defects for 3 years from the date of purchase (except as noted below). If at any time during the first 3 years after purchase your Nova Max Pro Creat and eGFR Meter does not work for any reason (other than as described below), it will be re- placed with a new Meter, or a substantial equivalent, free of charge.
  • Page 76 4. There is no other express warranty for this product. The option of a replacement, described above, is 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 information responsibly and in compliance with the law.

  • Page 77: Serious Incidents/Adverse Advents

    Appendix Serious Incidents/Adverse Advents Nova Biomedical recommends users report any serious incidents/ adverse 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 eGFR MeterIFU Manual PRO PN64322.indd 69...
  • Page 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...
  • Page 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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