NOVA BIOMEDICAL MAX PRO CREATININE eGFR Manual

For
Investigational
Use Only
NOVA MAX PROCREATININE and eGFR
METER SYSTEM
eGFR MeterIFU Manual PRO PN040921.indd 1 8/18/21 9:59 AM
eGFR MeterIFU Manual PRO PN64322.indd 1eGFR MeterIFU Manual PRO PN64322.indd 1 1/14/22 3:42 PM1/14/22 3:42 PM

eGFR MeterIFU Manual PRO PN64322.indd 2eGFR MeterIFU Manual PRO PN64322.indd 2 1/14/22 3:42 PM1/14/22 3:42 PM

Nova Max Pro™ Creatinine and eGFR Meter System
Instructions for Use Manual
Nova Biomedical Corporation
200 Prospect Street
Waltham, MA 02454-9141 U.S.A.
Customer Service Telephone: [phone]
or contact your local distributor
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 3eGFR MeterIFU Manual PRO PN64322.indd 3 1/14/22 3:42 PM1/14/22 3:42 PM

Hessenring 13A
Geb. G
64546 Mörfelden-Walldorf Germany
REP
EC Nova Biomedical GmbH
eGFR MeterIFU Manual PRO PN64322.indd 4eGFR MeterIFU Manual PRO PN64322.indd 4 1/14/22 3:42 PM1/14/22 3:42 PM

Symbols
The following are symbols that are used in this manual, on insert
sheets, and on the Meter.
In vitro diagnostic medical
device
REP
EC
Authorized Representative
in the European Community
Caution
Consult instructions 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 Number
Control
n
 Containssufcientfor 
<n>tests
Device complies with Part
15 of the FCC rules
Bluetooth
eGFR MeterIFU Manual PRO PN64322.indd 5eGFR MeterIFU Manual PRO PN64322.indd 5 1/14/22 3:42 PM1/14/22 3:42 PM

• 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 CreatinineTest Strips and the Nova Max
Pro Creat eGFR Control Solutions.
• Your Meter uses a rechargeable, 3.7V Li-Polymer battery. To begin
using your Meter, 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 Warnings:
NOTES provide helpful operating information.
CAUTIONS provide information that is important for instrument
protection.
WARNINGS provide information that is important for user protection
or about the risk of inaccurate results.
Important Information!
eGFR MeterIFU Manual PRO PN64322.indd 6eGFR MeterIFU Manual PRO PN64322.indd 6 1/14/22 3:42 PM1/14/22 3:42 PM

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
When to Perform a Quality Control Test.........................................................28
Important Information for Control Solution.................................................29
Testing a Control Solution...................................................................................31
TOC-1
eGFR MeterIFU Manual PRO PN64322.indd 7eGFR MeterIFU Manual PRO PN64322.indd 7 1/14/22 3:42 PM1/14/22 3:42 PM

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
Specications...........................................................................................................60
Accuracy and Precision.........................................................................................62
Ordering Information............................................................................................66
Warranty ....................................................................................................................67
Serious Incidents/Adverse Advents.................................................................69
Revision History ......................................................................................................69
Table of Contents
TOC-2
eGFR MeterIFU Manual PRO PN64322.indd 8eGFR MeterIFU Manual PRO PN64322.indd 8 1/14/22 3:42 PM1/14/22 3:42 PM

1
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 ngertip
for screening of kidney health by calculating Estimated Glo-
merular Filtration Rate (eGFR). It is intended for multiple patient
use in Near-Patient/Point of Care and professional 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-disabling
lancing devices. It is not intended to diagnose a specic kidney
disease or condition. The system should not be used to alter
kidney disease treatment by changing any medication schedule
or dosage unless specically instructed by a healthcare profes-
sional.
eGFR MeterIFU Manual PRO PN64322.indd 1eGFR MeterIFU Manual PRO PN64322.indd 1 1/14/22 3:42 PM1/14/22 3:42 PM

2
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.
• Test resultsare best obtained when used within an operating rela-
tive humidity of 10% to 90% (non-condensing). Testing outside
this range may cause inaccurate results.
• Altitude – There is no eect of altitudes up to 12,000 feet (3658
meters) above sea level.
• Meteroperationaltemperaturerange: 59°F to 104°F (15°C to 40°C)
eGFR MeterIFU Manual PRO PN64322.indd 2eGFR MeterIFU Manual PRO PN64322.indd 2 1/14/22 3:42 PM1/14/22 3:42 PM

3
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 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(+) Maltose Monohydrate 500 mg/dL
Methyl Dopa 2 mg/dL
Salicylate 48 mg/dL
Tolazamide 25 mg/dL
Tolbutamide 25 mg/dL
Triglyceride 750 mg/dL
Uric Acid 20.0 mg/dL
eGFR MeterIFU Manual PRO PN64322.indd 3eGFR MeterIFU Manual PRO PN64322.indd 3 1/14/22 3:42 PM1/14/22 3:42 PM

4
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.
Healthcare professionals and others must wear gloves while
using this system on multiple patients and should be aware that
all products or objects that come into contact with human blood
should be handled as if capable of transmitting viral diseases,
even after cleaning.
Important Safety Instructions
eGFR MeterIFU Manual PRO PN64322.indd 4eGFR MeterIFU Manual PRO PN64322.indd 4 1/14/22 3:42 PM1/14/22 3:42 PM

5
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.
3. The Nova Max Pro Creatinine and eGFR Meter System may
only be utilized for testing on multiple patients when Standard
Precautions are followed and when the system is cleaned and
disinfected after use on each patient following the Cleaning
and Disinfecting Procedure. Healthcare professionals should
wear a new pair of protective gloves before testing each new
patient.
Important Safety Instructions
eGFR MeterIFU Manual PRO PN64322.indd 5eGFR MeterIFU Manual PRO PN64322.indd 5 1/14/22 3:42 PM1/14/22 3:42 PM

6
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/.
“Protection of Laboratory Workers From Occupationally Ac-
quired Infection ; Approved Guideline - Fourth Edition,” Clinical
and Laboratory Standards Institute (CLSI) M29-A4. CDC Clinical
Reminder: Use of Fingerstick Devices. https://www.cdc.gov/
injectionsafety/ngerstick-devicesbgm.html
Important Safety Instructions
eGFR MeterIFU Manual PRO PN64322.indd 6eGFR MeterIFU Manual PRO PN64322.indd 6 1/14/22 3:42 PM1/14/22 3:42 PM

7
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 Modications not expressly approved by Nova Bio-
medical Corporation can void your authority to operate this equip-
ment under Federal Communications Commissions rules.
Important Safety Instructions
eGFR MeterIFU Manual PRO PN64322.indd 7eGFR MeterIFU Manual PRO PN64322.indd 7 1/14/22 3:42 PM1/14/22 3:42 PM

8
1. This device may not cause interference.
2. This device must accept any interference, including interference
that may cause undesired operation of the device.
L’émetteur/récepteur exempt de licence contenu dans le présent appareil
est conforme aux CNR d’Innovation, Sciences et Développement
économique Canada applicables aux appareils radio exempts de licence.
L’exploitation est autorisée aux deux conditions suivantes :
1. L'appareil ne doit pas produire de brouillage;
2. L'appareil doit accepter tout brouillage radioélectrique subi, même si
le brouillage est susceptible d'en compromettre le fonctionnement.
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:
eGFR MeterIFU Manual PRO PN64322.indd 8eGFR MeterIFU Manual PRO PN64322.indd 8 1/14/22 3:42 PM1/14/22 3:42 PM

9
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 procient in the operating
and maintenance 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 future refer-
ence.
3. Observe all warnings on the Meter and in the operating in-
structions.
4. Follow all operating and use instructions.
Important Safety Instructions
eGFR MeterIFU Manual PRO PN64322.indd 9eGFR MeterIFU Manual PRO PN64322.indd 9 1/14/22 3:42 PM1/14/22 3:42 PM

10
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.
Devices/Accessories: To ensure the product is disposed properly,
decontaminate the product according to the instructions provided
in chapter on " cleaning and disinfecting the meter" of this manual
and hand over the product to the applicable collection point for
the recycling of electrical and electronic equipment.
Important Safety Instructions
eGFR MeterIFU Manual PRO PN64322.indd 10eGFR MeterIFU Manual PRO PN64322.indd 10 1/14/22 3:42 PM1/14/22 3:42 PM

11
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. 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 Information
• Use only Nova Max Pro Creat eGFR Creatinine Test Strips when
testing.
• Remove the Test Strip from the vial only when ready to test.
eGFR MeterIFU Manual PRO PN64322.indd 11eGFR MeterIFU Manual PRO PN64322.indd 11 1/14/22 3:42 PM1/14/22 3:42 PM

12
• 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 theTest Strips in their original vial only: do not transfer strips
between vials.
• After removing aTest Strip from the vial, immediately 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 months after the rst
opening.
Controls
• Storage temperature for the Nova Max Pro Creat eGFR Control
Solution: 35.6°F to 46.4°F (2°C to 8°C)
Introduction
eGFR MeterIFU Manual PRO PN64322.indd 12eGFR MeterIFU Manual PRO PN64322.indd 12 1/14/22 3:42 PM1/14/22 3:42 PM