manual - H-P-COSMOS Sports and Medical

IMPORTANT NOTE: PLEASE READ THE FOLLOWING PRODUCT INFORMATION
CAREFULLY BEFORE USING THE H/P/COSMOS SIRIUS TEST STRIPS!
Lactate - test strips
Product information about the h/p/cosmos sirius test strips for one-time disposable use
with the h/p/cosmos sirius analyzer to determine lactate in whole blood
INTENDED USE
h/p/cosmos sirius test strips are only to be used with the h/p/cosmos sirius analyzer to determine the lactate content in capillary blood. For in-vitroapplication
only! The h/p/cosmos sirius test strips and the h/p/cosmos sirius analyzer can be used both by individuals and by health personnel.
WARNING NOTICES
Please ensure the h/p/cosmos sirius analyzer and accessories are kept out of reach of children, to prevent accidents through improper handling
and to avoid the risk of small parts being swallowed!
If you get results which are unexpectedly high or low, then the measurement may be affected by substances like sweat or alcohol from the disin-
fecting pad: If sweat and/or alcohol is mixed with the blood sample, the reading may be incorrect. Clean the area for the sample uptake carefully
with water and dry thoroughly. If you think the measurement is wrong, repeat the measurement with a new test strip and check the meter with the
h/p/cosmos sirius control solution under the menu display „dSC“, as described in the instruction manual.
Read the instruction manual and package insert before using the h/p/cosmos sirius!
Measuring lactate carries the risk associated with exposure to blood and infection: Please make sure items containing blood such as test
strips, lancets and alcohol swabs are disposed of properly according the local regulations, to avoid any risk to third parties. Should the h/p/cosmos
sirius analyzer, the lancing device or any other item come into contact with blood, please use an alcohol swab to clean and to disinfect it. Medical
personnel should observe the internal regulations of their particular institution. Always wear gloves when you are carrying out a measurement
on another person!
STORAGE AND HANDLING
• Transport and store the test strip only in the original vial with the correct code information.
• The vial should be kept closed at all times to maintain the guaranteed shelf life.
• Keep the test strips protected from moisture, light, and long period of time above +46 o F (+8 o C).
• Before using refrigerated test strips, take the closed vial out and keep at room temperature for 20 minutes at least.
• Take out the individual test strip just before using it and close the vial immediately. Never leave the vial open!
• Wash and dry your fi ngers before handling the strips. Avoid touching the ends of the strips, pick them up in the middle.
• Do not write on the test strip, or scratch, bend, fold or damage it before use.
APPLICATION / ONE - TIME DISPOSABLE USE
• h/p/cosmos sirius-test strips are to be used only with the h/p/cosmos sirius analyzer. Please follow the attached instructions!
• Do not reuse test strips which have been used or use strips that are contaminated, that show conspicious changes or have passed the
expiration date indicated on the label of the original vial.
• Make sure that the test strip you insert comes from a vial with the same code that appears on the display of the analyzer. If the code does
not match, take off the test strip again and reset the code number of the analyzer as described.
• Disinfect the fi ngertip or earlobe carefully with an alcohol swab.
• Remove any residue (sweat or alcohol) from the skin with fresh water and and dry it thoroughly with a clean tissue before pricking.
• Squeeze slightly the surrounding area to get the blood sample and wipe away the fi rst drop of blood. Use the next drop of blood that forms
for measurement.
• Lower the tip of the inserted strip to the fresh drop of blood until it is absorbed.
• When the required sample volume is taken up completely, it will be confi rmed by a beep signal, and „LAC“ appears on the display.
• After the test, take the test strip in the middle, remove it from analyzer and dispose of it properly according the local regulations.
Do the same with the used lancet and any other disposable material that have contacted blood.
1. Take out the test strip, insert it according the illustration 2. Insert a new lancet in the lancing device
3. Twist the protective cap off 4. Disinfect and clean 5. Load and release the lancet 6. Lower the strip to the drop
KEY TO THE SYMBOLS / LEGEND
Expiry date for the Batch No. for Number of test Calibration code, to
unopened vial quality proof strips in the vial set into the analyzer
Keep away from children!
For in-vitro-application only!
Only store in original vial!
Protect from light, moisture and
longer storage temperatures
above +46°F / +8°C !
After opening the vial of test strips,
the storage stability will be reduced.
Support: www.h-p-cosmos.com
LIFE SUPPORT POLICY
H/P/COSMOS SIRIUS - PRODUCTS ARE NOT AUTHORIZED
FOR USE AS CRITICAL COMPONENTS IN LIFE SUPPORT
DEVICES OR SYSTEMS WITHOUT THE EXPRESSLY WRIT-
TEN APPROVAL OF THE MANUFACTURERS PRESIDENT
OF SENSLAB GMBH, GERMANY.
FDA owner / operator number: 9064575
FDA establishment registration number: 3004635143
The device is 510(k) exempt under 21CFR 862.1450

IMPORTANT NOTE: PLEASE READ THE FOLLOWING PRODUCT INFORMATION
CAREFULLY BEFORE USING THE H/P/COSMOS SIRIUS TEST STRIPS!
Product information about the h/p/cosmos sirius test strips for one-time disposable use
with the h/p/cosmos sirius analyzer to determine lactate in whole blood
SPECIAL RULES FOR LACTATE MEASUREMENT
The h/p/cosmos sirius is easy to handle: Nevertheless, sampling for lactate measurement has to follow some special rules to get meaningful
results. One of the main reasons for wrong results is the contamination of the blood drop by sweat. The human skin is always covered with sweat,
which contains a great deal of lactate. Due to the high density of sweat glands, especially in the fi ngertips, sweat is continuously secreted and
accumulated at the surface. If the fi nger was not washed by water, lactate accumulated from the sweat will be dissolved by the blood drop immediately
after puncturing and the lactate reading will be much higher than it should be. Therefore, if possible, professional users prefer to draw the
blood from the earlobe because there sweat secretion is much lower.
In any case, to avoid taking an unclean sample ensure that the area (fi ngertip or earlobe) is cleaned carefully with water before sampling. Please
note that alcohol swabs can disinfect your puncture area, but alcohol does not dissolve the lactate residue from the sweat. In addition, do not
use saliva for cleaning, because it contains lactate also. To avoid other contaminations or dilution of the blood drop, dry the puncture area after
cleaning / disinfection thoroughly. After puncture, the fi rst drop should be wiped away and the next drop that forms should be used immediately for
the measurement. Within a few seconds, physical and chemical parameters of the blood drop are changing and sweat will be produced permanently
which increases the lactate concentration. Hence, the delay time between drop generation and measurement should be very short.
The lactate level of the blood depends on the individual metabolism of the body and of the state of the metabolism. Especially the glycogen
storage of the body can affect the lactate level. E.g., the lactate concentration of the blood increases immediately after a meal. Depending on
the individual metabolic activity, at least 90 minutes are required to approach a normal level between 1 - 2 mmol/l again. In contrast, after a hard
physical exercise or diet, the glycogen storage is diminished and the glucose release from glycogen is limited for several (up to 24) hours resulting
in lower lactate concentrations. For meaningful results it is recommended to carry out a step test (see below) under normal metabolic conditions.
Diabetic, overweight, stressed or untrained persons or persons with heart diseases usually will fi nd increased lactate values. Here it is strictly
recommended to collaborate closely with a doctor for supervision ensuring a careful and qualifi ed training control.
HOW TO UNDERSTAND THE READINGS
The lactate values that are obtained for certain effort levels must be charted as points (y-axis) above the corresponding values of running velocity or
power (x-axis). The resulting curve which is obtained from the serial connection of these points has to be evaluated within the range between 2 mmol/l
and 6 mmol/l. According to the Mader-model the anaerobic threshold is defi ned at 4 mmol/l. The more a proband is trained, the more on the right the
curve will pass the anaerobic threshold of 4 mmol/l.
The steady state anaerobic threshold has an average of 4 mmol/l. But this value does not represent the individual characteristics of one‘s metabolism:
The anaerobic threshold of an untrained person can be between 5 - 6 mmol/l lactate. In contrast, the anaerobic threshold of professionals usually ranges
between 2.5 - 3 mmol/l lactate but passing at a much higher effort level. For that reason, the „individual anaerobic threshold (IAT)“ was introduced into
sports medicine. Meanwhile there exist about 15 different methods and models to determine the IAT. Most of them are based on the determination of a
well-defi ned increase of the lactate concentration via a tangent-method: For example, an angle of 45 was detected for runners using the running velocity
as the effort level.
To choose the proper testing method and an aligned evaluation system, it is advisable to proof carefully its performance and handling and use them
long-term in an analogous manner. For ambitious amateurs and competitive athletes it is recommended to collaborate with experts of sports science and
coaching, to carry out the measuring at an optimum time and to use the data for effective improvement of endurance and fi tness. The application of an
analyzer software (e.g. „h/p/cosmos sirius Assistant“ or „h/p/cosmos para analysis“) makes it much easier to illustrate and to interpret the data.
TECHNICAL DATA
Measuring method: The lactate of the sample is oxidized by the enzyme lactate oxidase. In the course of this redox
reaction electrons are transferred via an additional electron mediator from the enzyme to a working
electrode. This resulting measuring current corresponds with the lactate concentration.
Measuring range: 0.5 - 25.0 mmol/l
Sample volume: 0.5 µl
Coeffi cient of Variation: 3.0 - 8.0% (depends on concentration; validated average)
Reagent per test strip: Lactate oxidase, electron mediator, additives
Interfering compounds: An increase of the readings up to 0.4 mmol/l is possible by uric acid at its highest physiological
concentration and by acetaminophen/paracetamol at the highest therapeutic concentration applied.
Haematocrit values above 0.5 l/l lead to higher results. Drugs taken may cause unexpected results.
Contamination of the small blood sample with sweat or alcohol will result in inaccurate readings:
Sweat (and saliva) contains a high lactate concentration. If alcohol or other solvents in the disinfecting
pad mix with the blood drop, the red blood cells of the sample could be hemolyzed, so that com-
pounds of the cells are released, causing inaccurate test results.
Infl uence of temperature: The h/p/cosmos sirius is equipped with a temperature sensor, located below the test strip slot. The test
results are adjusted automatically by an algorithm to enable reliable measurement in all kinds of temperatures.
If the temperature before testing is too high or too low, the h/p/cosmos sirius will not function
(no display of drop symbol): The analyzer displays a thermometer symbol then.
If the temperature is below +41o F (+5o C), keep the device and the test strips near your body or in a
warm and protected place. If the analyzer and the test strips have been exposed to extreme temperatures
(lower than +41o F (5o C), or higher than +104o F (45o C)), a transition time of 20 min is needed.
Ensure that the test strips and the meter are approximately at the same temperature.
Health note: There are no known health risks from using h/p/cosmos sirius test strips according to the instructions if
the test results are not used for therapeutic purposes (regard the life support policy on the front page).
The test strip contains biologic material of animal origin. Risks of infection cannot be ruled out absolutely
if the test strip is ingested.
If you fell ill during testing, consult a doctor immediately, especially in case of improper use of the
lancing device, swallowing of test strips, control solution, batteries or lancets.
Persons prone to excessive bleeding or infection should consult a doctor before puncturing puncturing.
Control solution (option): Contains lactate, buffer solution, and additives for viscosity adjustement and stabilisation.
Do not swallow! Keep away from children! After fi rst opening of the bottle, the storage stability is
three months at a storage temperature of +41 - 77o F (+5- 25o C) or until expiration if it‘s sooner.
Open the bottle only immediately before application. Close it tightly afterwards. after Do not dilute!
Additional control solutions are available as a regular content of the h/p/cosmos sirius „BigPack 72+“.
Please read the instruction manual before using the control solution and the „dSC“-option!
Distributed by: Manufacturer:
h/p/cosmos sports & medical gmbh
Am Sportplatz 8
DE 83365 Nussdorf-Traunstein / Germany
phone +49 (0) 8669 / 8642-0
fax +49 (0) 8669 / 8642-49
sales@h-p-cosmos.com
www.h-p-cosmos.com
Gesellschaft zur Entwicklung und Herstellung
bioelektrochemischer Sensoren mbH
Bautzner Straße 67
D - 04347 Leipzig
Tel.: 03 41 - 2 34 18 30
Fax: 03 41 - 2 34 18 40
www.senslab.de
info@senslab.de
Release: hpc-BPZ-TS-en_Rev 1.0_27.09.2010 0123