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: 1-781-647-3700
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
Containssufcientfor
<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
Specications...........................................................................................................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 specic kidney
disease or condition. The system should not be used to alter
kidney disease treatment by changing any medication schedule
or dosage unless specically 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 eect 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
Table of contents
Other NOVA BIOMEDICAL Measuring Instrument manuals
NOVA BIOMEDICAL
NOVA BIOMEDICAL Stat Profile PRIME User manual
NOVA BIOMEDICAL
NOVA BIOMEDICAL StatStrip Xpress Manual
NOVA BIOMEDICAL
NOVA BIOMEDICAL Lactate Plus Manual
NOVA BIOMEDICAL
NOVA BIOMEDICAL Max Creat eGFR User manual
NOVA BIOMEDICAL
NOVA BIOMEDICAL Nova StatSensor Xpress-i Manual
NOVA BIOMEDICAL
NOVA BIOMEDICAL STATSTRIP User manual
