NOVA BIOMEDICAL Lactate Plus Manual

i
Instructions for Use Manual
PN62659B1 Lactate Plus IFU EN.indd 1PN62659B1 Lactate Plus IFU EN.indd 1 8/5/22 11:54 AM8/5/22 11:54 AM

PN62659B1 Lactate Plus IFU EN.indd 2PN62659B1 Lactate Plus IFU EN.indd 2 8/5/22 11:54 AM8/5/22 11:54 AM

i
Contents
Quick Reference Guide...........................................................1
Symbols.................................................................................5
Intended Use .........................................................................6
Limitations .............................................................................7
Safety ....................................................................................8
Introduction.......................................................................... 11
The Lactate Plus Meter ................................................... 11
Overview .........................................................................15
Meter, Supplies, Transport Case.....................................16
Environmental Specications ..........................................16
Disposal of Used Batteries and Meters
for Customers in Europe .................................................17
Interfering Substances ....................................................18
PN62659B1 Lactate Plus IFU EN.indd 1PN62659B1 Lactate Plus IFU EN.indd 1 8/5/22 11:54 AM8/5/22 11:54 AM

ii
Setup ...................................................................................20
Installing the Battery (Replacing) ....................................20
Set the Date and Time ....................................................22
Set Time Format..............................................................22
Set Date Format..............................................................25
Beeper On or Off.............................................................28
End of Setup ...................................................................29
Testing: Blood and Quality Control Solutions ......................30
Testing a Quality Control Solution ...................................32
Important Safety Instructions ..........................................35
Testing a Blood Sample ..................................................37
Data Review ........................................................................44
Data Review....................................................................44
Manually Reviewing Stored Test or Control Results .......44
Basic Upkeep ......................................................................46
PN62659B1 Lactate Plus IFU EN.indd 2PN62659B1 Lactate Plus IFU EN.indd 2 8/5/22 11:54 AM8/5/22 11:54 AM

iii
Cleaning and Disinfecting the Meter ...............................46
General Precautions for Cleaning and Disinfecting the
Meter ...............................................................................53
Error Messages ...................................................................56
Codes..............................................................................56
Appendix..............................................................................57
Specications ..................................................................57
Ordering Information .......................................................59
Performance Characteristics...........................................59
Accuracy .........................................................................60
Methodology....................................................................61
Precision .........................................................................62
Traceability ......................................................................64
Instructional Notes ..........................................................66
Warranty..........................................................................70
PN62659B1 Lactate Plus IFU EN.indd 3PN62659B1 Lactate Plus IFU EN.indd 3 8/5/22 11:54 AM8/5/22 11:54 AM

iv
PN62659B1 Lactate Plus IFU EN.indd 4PN62659B1 Lactate Plus IFU EN.indd 4 8/5/22 11:54 AM8/5/22 11:54 AM

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 lancet is for single-use
only. The needle retracts immediately
after sampling. This leaves the device
safe for immediate disposal into a
sharps container. To reduce the risk
of pre-analytical error, facilities should
consider using a 21-gauge lancet when
collecting capillary samples.
a
b
Quick Reference Guide
PN62659B1 Lactate Plus IFU EN.indd 1PN62659B1 Lactate Plus IFU EN.indd 1 8/5/22 11:54 AM8/5/22 11:54 AM

2
Insert Test Strip: Automatic
System Check begins.
User Prole Number displays:
use the left or right
arrow button to select prole.
2. Insert a Test Strip.
Quick ReferenceGuide
MODELeft Arrow Right Arrow
PN62659B1 Lactate Plus IFU EN.indd 2PN62659B1 Lactate Plus IFU EN.indd 2 8/5/22 11:54 AM8/5/22 11:54 AM

3
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 single-use, disposable
safety 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
PN62659B1 Lactate Plus IFU EN.indd 3PN62659B1 Lactate Plus IFU EN.indd 3 8/5/22 11:54 AM8/5/22 11:54 AM

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
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
PN62659B1 Lactate Plus IFU EN.indd 4PN62659B1 Lactate Plus IFU EN.indd 4 8/5/22 11:54 AM8/5/22 11:54 AM

5
The following are symbols that are used in this manual, on
insert sheets, and on the Lactate Plus Meter.
Symbols
In vitro diagnostic medical
device
REP
EC
Authorized Representative
in the European
Community
Caution, consult
accompanying documents
Consult instructions for use
Biological Risk
Control
Lot Number
SN
Serial Number
Temperature Limitation
Manufacturer
Date of Manufacture
Contents
Catalog Number
Use By Date
Electronic Waste
Device for near-patient
testing
PN62659B1 Lactate Plus IFU EN.indd 5PN62659B1 Lactate Plus IFU EN.indd 5 8/5/22 11:54 AM8/5/22 11:54 AM

6
Nova Biomedical recommends that the user of this device
read this manual and accompanying product inserts
completely 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
associated with Lactate values in whole blood.
PN62659B1 Lactate Plus IFU EN.indd 6PN62659B1 Lactate Plus IFU EN.indd 6 8/5/22 11:54 AM8/5/22 11:54 AM

7
Limitations
• Do not use the Lactate Plus Meter System in the
diagnosis, treatment, or monitoring of disease or other
conditions.
• Use only capillary or venous whole blood.
• Do not use serum or plasma.
• There is no effect of altitudes up to 12,000 feet
(3,658 meters) above sea level.
• Testing outside of Lactate Plus System environmental
specications may cause inaccurate results.
• Testing of blood sample with Hematocrit outside of
20% - 65% range may cause inaccurate results.
PN62659B1 Lactate Plus IFU EN.indd 7PN62659B1 Lactate Plus IFU EN.indd 7 8/5/22 11:54 AM8/5/22 11:54 AM

8
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.
Safety
PN62659B1 Lactate Plus IFU EN.indd 8PN62659B1 Lactate Plus IFU EN.indd 8 8/5/22 11:54 AM8/5/22 11:54 AM

9
Personnel 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 reference.
3. Observe all warnings on the meter and in the
operating instructions
4. Follow all operating and use instructions.
5. Place the meter away from heat sources.
6. The meter should be cleaned only as recommended
by the manufacturer.
7. The meter should be serviced by qualied service
personnel.
Safety
PN62659B1 Lactate Plus IFU EN.indd 9PN62659B1 Lactate Plus IFU EN.indd 9 8/5/22 11:54 AM8/5/22 11:54 AM

10
Electrical Safety
1. Battery powered: 2 AAA batteries
Chemical and Biological Safety
1. Observe all precautionary information printed on the
original solution containers.
2. Operate the meter in the appropriate environment.
3. Dispose of all waste solutions according to standard
hospital procedures.
Safety
PN62659B1 Lactate Plus IFU EN.indd 10PN62659B1 Lactate Plus IFU EN.indd 10 8/5/22 11:54 AM8/5/22 11:54 AM

11
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
PN62659B1 Lactate Plus IFU EN.indd 11PN62659B1 Lactate Plus IFU EN.indd 11 8/5/22 11:54 AM8/5/22 11:54 AM

12
Lactate Plus Meter
LCD Display
Mode
Button
Right Arrow
Button
Eject Button:
Bottom-Middle-
Back
Left Arrow
Button
Lactate Plus
Test Strip
Introduction
PN62659B1 Lactate Plus IFU EN.indd 12PN62659B1 Lactate Plus IFU EN.indd 12 8/5/22 11:54 AM8/5/22 11:54 AM

13
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 proles. P-0 user prole can store
up to 20 test results, P-1 to P-9 can store up to 10
test results in each prole;
• 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
PN62659B1 Lactate Plus IFU EN.indd 13PN62659B1 Lactate Plus IFU EN.indd 13 8/5/22 11:54 AM8/5/22 11:54 AM

14
User Prole Number
Date/Day of Test
Current Date/Day
Test Result in
Memory Indicator
Time of Test
Beeper ON Indicator
User Prole ICON
Lactate Test Result
(in mmol/L)
Current Time Display
Lactate Plus Meter Screen
Introduction
PN62659B1 Lactate Plus IFU EN.indd 14PN62659B1 Lactate Plus IFU EN.indd 14 8/5/22 11:54 AM8/5/22 11:54 AM