NOVA BIOMEDICAL Max Creat eGFR Manual de usuario
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: 1-781-647-3700
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 fullls 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
Specications...........................................................................................................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 specic 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 specically instructed by a healthcare professional.
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2
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 obtainedfromthengertip.
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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