NOVA BIOMEDICAL Lactate Plus Manual

Instructions for Use Manual
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Quick ReferenceGuide ......................................................................1
Intended Use ....................................................................................5
Symbols............................................................................................7
Warnings, Cautions, and Notes........................................................8
Introduction.......................................................................................9
The Lactate Plus Meter.................................................................9
Overview.....................................................................................13
Meter, Supplies, Transport Case.................................................14
Environmental.............................................................................15
Setup ..............................................................................................16
Set the Time................................................................................16
Set Date Format..........................................................................19
Beeper On or Off.........................................................................22
End of Setup ...............................................................................23
Testing: Blood and Quality Control Solutions .................................24
Testing a Quality Control Solution...............................................25
Important Safety Instructions ......................................................27
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Testing a Blood Sample ..............................................................30
Data Review ...................................................................................35
Data Review................................................................................35
Manually Reviewing Stored Test or Control Results ...................35
Battery Replacement ..................................................................37
Cleaning and Disinfecting the Meter...........................................38
Disposal of Used Batteries for Customers in Europe..................44
Disposal of Used Meters for Customers in Europe.....................44
Error Messages ..............................................................................45
Codes, Alerts, Actions.................................................................45
Appendix.........................................................................................46
Specications..............................................................................46
Performance Characteristics.......................................................48
Accuracy .....................................................................................49
Precision .....................................................................................50
Instructional Notes ......................................................................52
Warranty .....................................................................................56
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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 device is single-use.
The needle retracts immediately
after sampling. This leaves
the device safe for immediate
disposal into a sharps container.
a
b
Quick ReferenceGuide
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Insert Test Strip: Automatic
System Check begins.
User Prole Number displays:
use Search key to
select prole.
2. Insert a Test Strip.
MODESEARCH SELECT
Quick ReferenceGuide
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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 sufcient blood has been
added to the test strip.
The Lactate result is available
on-screen in 13 seconds.
Quick ReferenceGuide
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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
device 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. The meter is in-
tended for use by healthcare professionals to quantitatively
measure lactate in whole blood to evaluate physical perfor-
mance and/or to establish a proper intensity of exercise for
athletes.
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Symbols
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 fullls the requirements
of Directive 98/79 EC (IVDD)
Caution, consult accompanying
documents
Consult instructions for use
Biological risk
Use By
Lot Number
Electronic Waste
Catalog number
Temperature limitation
Upper Limit of Temperature
Manufactured by
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Warnings, Cautions, and Notes
NOTES provide important or helpful operating information.
CAUTIONS provide information that is important for instru-
ment protection.
WARNINGS provide information that is important for user
protection or about risk for inaccurate results.
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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
Search Button
Mode
Button
Select
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.
• There is memory for one common user’s set of test
results (20):
Nine specic users’ set of test results (10 each);
Two sets of Quality Control (QC) results (10 each)
• The unit is powered by a battery that can perform for
approximately 600 tests.
Introduction
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User Prole Number
Quality Control
Indicator
Low Battery
Indicator
Blood or Control
Drop Indicator
Test Result in
Memory Indicator
Beeper ON Indicator
User Prole ICON
Lactate Test Result
(in mmol/l)
AM or PM Indicator
Date/Day Hour/Minute
Lactate Plus Meter Screen
Introduction
Average Test Result
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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;
places a drop of sample onto the test strip; and obtains a
lactate test result in 13 seconds. The test result is automati-
cally 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 prole’s
results.
Introduction
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Meter, Supplies, Transport Case
The Nova Lactate Plus Meter (40828) comes in a soft carry-
ing case that includes:
1. Lactate Plus Meter with Battery
2. Instructions for Use Manual
3. Quick Reference Guide
See Page 48 for a listing of supplies and accessories.
Introduction
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Environmental
• The storage temperature range for the Meter:
-13°F to 115°F (-25°C to 46°C)
• The storage temperature range for the Test Strips and Control
Solutions: room temperature - 15°-30°C/59-86°F
• The meter operational temperature range for Lactate:
41°F to 113°F (5°C to 45°C)
• The relative humidity range: 10% to 90% non-condensing
Introduction
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Set the Time
• Press the MODE button for longer than 3 seconds. The
meter if in Sleep Mode wakes up and enters the SETUP
Mode.
• View the hour (ashing) format: either 12 Hr or 24 Hr by
pressing the SEARCH button to toggle between the
2 time format options available.
• Press the SELECT button to choose the Hour For-
mat.
• The meter displays the current time or the default time:
12:00 AM or 0:00 (hours).
• Press the SEARCH button to progress from 1AM to
12PM (for 12 Hr Clock) or 0 to 23 (for 24 Hr Clock). The
hour digits will be ashing until selected.
Setup
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