NOVA BIOMEDICAL Lactate Plus Manual

i
Quick Reference Guide ...........................................................1
Intended Use .........................................................................4
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

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Testing a Blood Sample ...................................................27
Data Review ........................................................................32
Data Review .....................................................................32
Manually Reviewing Stored Test or Control Results ........32
Battery Replacement ........................................................34
Cleaning and Care ...........................................................35
Error Messages ...................................................................36
Codes ...............................................................................36
Appendix .............................................................................37
Specifications ...................................................................37
Performance Characteristics ............................................39
Accuracy ..........................................................................40
Precision ..........................................................................41
Instructional Notes ...........................................................43
Warranty ...........................................................................47

1
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.
Quick Reference Guide

2
Insert Test Strip: Automatic
System Check begins.
User Profile Number displays:
use Search key to
select profile.
2. Insert a Test Strip.
MODE SEARCH SELECT
Quick Reference Guide

3
3. Prepare the Puncture Site.
c. The best puncture sites are on
the middle or ring finger. Clean the
finger tip thoroughly with soap and
water. Then dry thoroughly.
d. Place the auto-Lancet against
the pad of the finger, press the
release button, remove the device
from the finger.
e. Wait a few seconds for a blood
drop to form. Wipe off the first drop
with a clean tissue. Squeeze the
finger to form a second drop of
blood. Do not squeeze vigorously.
Quick Reference Guide

4
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
flashes on and off repeatedly
until sufficient blood has been
added to the test strip.
The Lactate result is available
on-screen in 13 seconds.
Quick Reference Guide

5
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.

6

7
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
Fulfills requirements of
Directive 98/79 EC (IVDD)
Caution, consult accompanying
documents
Consult instructions for use
Biological risk
Catalog number
Temperature limitation
Upper Limit of Temperature
Manufactured by

8
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.

9
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

11
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 specific 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 Profile Number
Quality Control
Indicator
Low Battery
Indicator
Blood or Control
Drop Indicator
Test Result in
Memory Indicator
Beeper ON Indicator
User Profile ICON
Lactate Test Result
(in mmol/l)
AM or PM Indicator
Date/Day Hour/Minute
Lactate Plus Meter Screen
Introduction
Average Test Result

13
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 profile’s
results.
Introduction

14
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 39 for a listing of supplies and accessories.
Introduction

15
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

16
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 (flashing) 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 flashing until selected.
Setup

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• Press the SELECT button to select the displayed
Hour choice.
• Next set the minutes. Press the SEARCH button to
progress from 00 to 59 minutes. The minute digits will be
flashing until selected.
• Press the SELECT button to select the displayed
Minutes choice.
Setup