NOVA BIOMEDICAL Lactate Plus Manual
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Instructions for Use Manual
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Lact Plus Meter PN 62659A84.indd 2Lact Plus Meter PN 62659A84.indd 2 11/18/19 5:11 PM11/18/19 5:11 PM
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Contents
Quick Reference Guide...........................................................1
Symbols.................................................................................5
Intended Use.........................................................................6
Warnings, Cautions, and Notes.............................................7
Introduction............................................................................9
The Lactate Plus Meter.....................................................9
Overview.........................................................................13
Meter, Supplies, Transport Case.....................................14
Environmental Specications ..........................................14
Disposal of Used Batteries..............................................15
Disposal of Used Meters ................................................15
Interfering Substances....................................................16
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Setup...................................................................................18
Installing the Battery (Replacing)....................................18
Set the Date and Time ....................................................20
Set Time Format..............................................................20
Set Date Format..............................................................23
Beeper On or Off.............................................................26
End of Setup ...................................................................27
Testing: Blood and Quality Control Solutions ......................28
Testing a Quality Control Solution...................................30
Important Safety Instructions ..........................................32
Testing a Blood Sample ..................................................35
Data Review........................................................................41
Data Review....................................................................41
Manually Reviewing Stored Test or Control Results.......41
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Basic Upkeep ......................................................................43
Cleaning and Disinfecting the Meter...............................43
General Precautions for Cleaning and Disinfecting the
Meter...............................................................................50
Error Messages...................................................................53
Codes..............................................................................53
Appendix..............................................................................54
Specications ..................................................................54
Accessories:....................................................................56
Performance Characteristics...........................................56
Accuracy .........................................................................57
Precision .........................................................................58
Instructional Notes ..........................................................60
Warranty..........................................................................64
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1.Prepare the lancet.
a. Simply twist off the lancet cap:
Hold the lancet body and twist off the
lancet cap until you feel it separate
from the device.
b. Do not pull, just twist the lancet
cap. Dispose of the cap in a suitable
container.
NOTE: This lancet is for single-use
only. The needle retracts immediately
after sampling. This leaves the device
safe for immediate disposal into a
sharps container. Nova Biomedical
recommends the use of a 21 gauge,
single use, disposable safety lancet for
capillary blood sampling.
a
b
Quick Reference Guide
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Insert Test Strip: Automatic
System Check begins.
User Prole Number displays:
use the left or right
arrow button to select prole.
2.Insert a Test Strip.
Quick ReferenceGuide
MODELeft Arrow Right Arrow
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3. Prepare the Puncture Site.
c. The best puncture sites are on
the middle or ring nger. Clean the
nger tip thoroughly with soap and
water. Then dry thoroughly.
d. Place the auto-Lancet against
the pad of the nger, press the
release button, remove the device
from the nger.
e. Wait a few seconds for a blood
drop to form. Wipe off the rst drop
with a clean tissue. Squeeze the
nger to form a second drop of
blood. Do not squeeze vigorously.
c
d
e
Quick ReferenceGuide
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4.Add Blood to Test Strip.
When the second blood drop
appears, touch the end of the
test strip to the blood drop until
the well of test strip is full and
the meter beeps.
The on-screen Blood Drop
ashes on and off repeatedly
until sufcient blood has been
added to the test strip.
The Lactate result is available
on-screen in 13 seconds.
Quick ReferenceGuide
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The following are symbols that are used in this manual, on
insert sheets, and on the Lactate Plus 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,consultaccompanying
documents
Consult instructions for use
Biological risk
Use By
Lot Number
Electronic Waste
Catalog number
Temperature limitation
Upper Limit of Temperature
Manufactured by
Symbols
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Nova Biomedical recommends that the user of this device
read this manual and accompanying product inserts com-
pletely before performing blood measurements.
Intended Use
The Lactate Plus Meter System is intended for use by
healthcare professionals to quantitatively measure lactate
in whole blood to evaluate physical performance and/or to
establish a proper intensity of exercise for athletes. The
meter system is for in vitro diagnostic use only. The Lactate
Plus sport meter is NOT intended for use in the diagnosis,
treatment, or monitoring of disease or other conditions as-
sociated with Lactate values in whole blood.
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WARNINGS provide information that is important for user
protection or about risk for inaccurate results.
CAUTIONS provide information that is important for instru-
ment protection.
NOTES provide important or helpful operating information.
Warnings, Cautions, and Notes
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The Lactate Plus Meter
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 lactate, i.e., test
strips, lancets, and alcohol swabs, must be disposed of in
accordance to local regulations to avoid risk to anyone.
WARNING: Please keep the Lactate Plus Meter and its
accessories out of reach of small children to prevent ac-
cidents through improper handling and to avoid the risk of
small parts being swallowed.
Introduction
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Lactate Plus Meter
LCD Display
Mode
Button
Right Arrow
Button
Eject Button:
Bottom-Middle-
Back
Left Arrow
Button
Lactate Plus
Test Strip
Introduction
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The Lactate Plus Meter is a hand-held testing device that
measures lactate (LAC) in whole blood. The test strip is
touched to a drop of blood to initiate the test process.
• A simple one-step process provides a blood lactate
result.
• Test result is available in 13 seconds.
• Supports 10 user proles. P-0 user prole can store
up to 20 test results, P-1 to P-9 can store up to 10 test
results in each prole;
• Stores up to 10 QC test results each for QC1 and QC2.
• The unit is powered by a battery that can perform for
approximately 600 tests.
Introduction
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User Prole Number
Date/Day of Test
Current Date/Day
Test Result in
Memory Indicator
Time of Test
Beeper ON Indicator
User Prole ICON
Lactate Test Result
(in mmol/L)
Current Time Display
Lactate Plus Meter Screen
Introduction
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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 high
temperatures.
Overview
To perform a test, the operator simply inserts a test strip;
touches the end of the test strip to the blood drop until the
well of the test strip is full and the meter beeps; and obtains
a lactate test result in 13 seconds. The test result is auto-
matically stored into the meter’s memory. The operator can
recall, delete, and review test data resident in the meter,
including the average for each control and user prole’s
results.
Introduction
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Meter, Supplies, Transport Case
The Nova Lactate Plus Meter (62623) comes in a soft carry-
ing case that includes:
1. Lactate Plus Meter with Battery
2. Instructions for Use Manual
See Page 56 for a listing of supplies and accessories.
Environmental Specications
• The meter operational temperature range for Lactate:
41°F to 113°F (5°C to 45°C)
• ThestoragetemperaturerangefortheTestStripsandControl
Solutions: room temperature 15°-30°C/59-86°F
• The relative humidity range: 10% to 90% non-condensing
Introduction
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