NOVA BIOMEDICAL Max Creat eGFR User manual

For
Investigational
Use Only
NOVA MAX CREAT eGFR MONITORING SYSTEM
For Investigational Use Only
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Nova Max®Creat eGFR Monitoring 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® is a Registered Trademark of Nova Biomedical Corporation
Made in the U.S.A. by Nova Biomedical Corporation
Copyright 2021 Nova Biomedical Corporation
PN 64548 Rev. A 12/2021
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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
Product fullls the requirements
of Directive 98/79 EC (IVDD)
Caution, consult accompanying
documents
Consult instructions for use
Biological risk
Use By
Lot Number
Only
Prescription Use Only
Electronic Waste
Catalog number
Temperature limitation
Upper Limit of
Temperature
Manufactured by
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• Before you begin using your new Nova Max Creat eGFR Meter,
please read all of the instructions provided in this Instructions
for Use Manual as well as the instructions provided in the Nova
Max Creat eGFR Test Strips and the Nova Max Creat eGFR Control
Solutions.
• Your Meter uses a rechargeable 3.7 V Li-Polymer battery.To begin
using your Meter, you may 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!
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Intended Use...................................................................................................................1
Important Safety Instructions...................................................................................2
Limitations ..................................................................................................................2
Blood-Borne Pathogens Safety............................................................................3
Federal Communications Commission (FCC) Notice........................... 5
Introduction ....................................................................................................................7
Nova Max Creat eGFR Meter.................................................................................7
General Safety............................................................................................................8
Before Testing ............................................................................................................9
Test Strips .................................................................................................................... 9
Important Nova Max Creat 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
When to Perform a Quality Control Test.........................................................22
Important Information for Control Solution.................................................23
TOC-1
Table of Contents
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Testing a Control Solution...................................................................................24
Testing a Blood Sample.............................................................................................29
Important Safety Instructions............................................................................29
Test Result .................................................................................................................33
Review Test Results in Memory.........................................................................35
Setting the Time, Date, Beeper, Versions ............................................................38
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
Specications...........................................................................................................62
Ordering Information............................................................................................64
Warranty ....................................................................................................................65
Table of Contents
TOC-2
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1
Intended Use
The Nova Max Creatinine and eGFR Monitoring System is intend-
ed for in vitro diagnostic use for the quantitative measurement of
creatinine in capillary whole blood obtained from the ngertip
for monitoring of kidney health by calculating Estimated Glo-
merular Filtration Rate (eGFR).
The system should only be used with 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 specic kidney disease or condi-
tion. The system should not be used to alter kidney disease
treatment by changing any medication schedule or dosage un-
less specically instructed by a healthcare professional.
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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 Creat and eGFR, i.e., Test Strips,
lancets, and alcohol swabs, must be disposed of in accordance with local
regulations to avoid risk to anyone.
Limitations
The Nova Max Creat eGFR Test Strips give accurate results when the
following limitations are observed:
• Blood–Use onlycapillarywholeblood obtainedfromthengertip.
Do not use serum or plasma.
• Donot usetheNovaMax CreateGFRTest Stripsfortestingneonates.
• Test results arebest obtainedwhen used withinan operating rela-
tive humidity of 10% to 90% (non-condensing). Testing outside
Important Safety Instructions
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3
this range may cause inaccurate results.
• Altitude – There is no eect of altitudes up to 12,000 feet (3658
Meters) above sea level.
Blood-Borne Pathogens Safety
1. Healthcare professionals and others using this system should
adhere to Standard Precautions when handling or using the
Nova Max Creat eGFR Monitoring System.
2. Healthcare professionals 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 healthcare professionals.
3. Only auto-disabling, single-use lancing devices may be used
with this system.
4. For more information, refer to the following references:
Important Safety Instructions
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“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 Infections; Approved Guideline-Third Edition,” Clinical
and Laboratory Standards Institute (CLSI) M29-A3.“FDA Public
Health Notication: Use of Fingerstick Devices on More than
One Person Poses Risk for Transmitting Bloodborne Pathogens:
Initial Communication.” (2010) http://www.fda.gov/Medicalde-
vices/Safety/AlertsandNotices/ucm224025.html. “CDC Clinical
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.
Important Safety Instructions
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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
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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:
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Introduction
The Nova Max Creat eGFR Meter
The Meter is a hand-held testing device that measures Creatinine
and eGFR levels in capillary whole blood obtained from the nger-
tip.
• A simple one-step process provides a Creatinine and 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 damage the Meter. Also, protect the Meter from
moisture, prolonged direct sunlight, and extreme temperatures.
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Introduction
General Safety
Persons 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.
5. Place the Meter away from heat sources.
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Introduction
Before Testing
To ensure accurate Creatinine and eGFR results, wash and thor-
oughly dry your hands before testing.
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.
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Introduction
Important Nova Max Creat eGFR Test Strip Information
• Use only Nova Max Creat eGFR Test Strips when testing.
• Remove the Test Strip from the vial only when ready to test.
• Storage temperature for the Nova Max Creat eGFR Test Strips and
Nova Max Creat eGFR Control Solution: 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.
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11
Introduction
Nova Max Creat eGFR Meter Components
LCD Display
Creat eGFR Test
Strip inserted here
eGFR Result
ml/min/1.73m2
Creat Result
mg/dL
Power
Button
Charging Cable
Connector
Home
Button Personal Settings
Button
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12
Charge the Meter’s battery before use. Connect the in-
cluded power supply to a wall outlet, then insert one end
of the charging cable into the power supply and the other
into the Meter’s charging cable connector. The Meter may
display the charging screen for several minutes. Once the
battery is suciently charged the Meter will prompt you to congure
it for use. In addition to selecting the Lan-
guage, Date, and Time, the Meter asks you
to enter your Age, Gender, and Ancestry for
accurate eGFR results. These settings can be
changed later in the Meter Settings menu
if desired .
Getting Started
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