EKF Lactate Scout+ User Manual

NEW
Compensated for hematocrit
Integrated BluetoothTM Technology
Lactate Scout+
Fast, accurate and reliable Lactate measurement
Results in 10 seconds
Only 0.2 μl sample volume
Simple to use
Mobile and ergonomic
Diagnostics for life
Easy to use
• Insert/remove sensor to turn on/o
• Jog dial navigation
• Only 0.2 µl of capillary blood required
• Pre-calibrated sensors
• Device calibrated by simple coding
• Lactate measurement, date/time, mode, temperature and memory ID on a single display
• Automatic self test
Fast and accurate
Performance measurement
Practical and reliable
• Enzymatic amperometric detection method
• Results within 10 seconds
• Measuring range: 0.5 - 25 mmol/L
• Compensates for the influence of low and high hematocrit levels
• Imprecision: ± 3 % (minimal standard deviation: ± 0.2 mmol/L) for Hct range 35 – 50%; ± 4 % (minimal standard deviation: ± 0.3 mmol/L) for extended Hct range
• Test solutions available for function control
• Single and step-test measurements (resting/exercise/recreation)
• Stopwatch and countdown timer functions
• Lactate Scout Assistant software available for performance management
• Free Lactate Scout data link software for simple transfer of results to PC
• Stores up to 250 results
• 1,000 tests using just 2 x AAA batteries
• Integrated Bluetooth™ connectivity
• Pocket-size: 91mm (h) x 55mm (w) x 24mm (d)
• Lightweight: 80g
• Operating range: 5-45°C and max. 85% humidity
Simple, accurate and reliable lactate measurement in 3 easy steps
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analyser.
Distributed by
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Prick finger and collect blood by touching with sensor.
Result appears in 10 seconds.Remove sensor and place into
Manufacturer
SensLab GmbH
Bautzner Strasse 67
04347 Leipzig
Germany
+49 (0) 39203 511 0
sales@ekfdiagnostics.com
ekfdiagnostics.com
Diagnostics for life
Revision EN EU 6.1-02.17
Sales and Service: EKF-diagnostic GmbH Ebendorfer Chaussee 3 39179 Barleben
Manufacturer:
SensLab GmbH An EKF Diagnostics Company Bautzner Str. 67 04347 Leipzig
Phone: +49 (0) 39203-785-0 Fax: +49 (0) 39203-785-24
www.ekfdiagnostics.com info@ekfdiagnostics.com
Phone: +49 (0) 341-234-18-41 Fax: +49 (0) 341-234-18-40
www.senslab.de info@senslab.de
Part number 7023-9012-2350
Rev. 2.0–11/2013
User Manual
Copyright© 2013 SensLab GmbH
No part of this publication may be reproduced, transmitted, transcribed, stored in any retrieval system or translated into any human or computer language by any means or in any form, without the prior written permission of Senslab GmbH.
Part Number: 7023-9012-2350 Rev. 2.0 –11/2013 Lactate Scout+ User Manual Valid from serial no. XXXXX02135
This product has been tested to the requirements of CAN/CSA-C22.2 No. 61010-1, second edition, including Amendment 1, or a later version of the same standard incorporating the same level of testing requirements.
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Manufacturer
SensLab GmbH
Bautzner Str. 67 04347 Leipzig Germany
Phone: (+49) 0341 - 234 18 41 Fax: (+49) 0341 - 234 18 40
www.senslab.de
Sales and Support:
EKF-diagnostic GmbH
Ebendorfer Chaussee 3 D-39179 Barleben Germany
Service: +49 (0) 39 203 78514 Email: support@ekf-diagnostic.de
www.ekfdiagnostics.com
Intended use and safety guidelines
• TheLactateScout+mayonlybeused with the Lactate Scout sensors to determine the lactate concentration in capillary whole blood. The Lactate Scout sensors are only for single use.
• Onlyforexternalapplicationoutsidethe
body. (In-vitro diagnostic application)
• LactateScout+issuitableforself-testing. It can also be used by qualied staff in various medical faculties. Test results should only be used as guidance in making decisions for further treatment of patients following a suitable period of evaluation.
• KeepLactateScout+andaccessoriesoutof
the reach of children (choking hazard due to small parts).
• Theprincipalriskofinfectionisinthe
handling of blood samples when measuring lactate concentrations.
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•Onlyundamagedandunusedlancets
and sensors may be used. Used sensors, lancets and cellulose cloths pose a risk of infection. These must be safely disposed of as household waste following use.
• Protectiveglovesmustbewornwhen
performing tests on third parties.
• Thesterilesingleuselancetsmayonly
be used to draw capillary blood on the ngertips or earlobes.
Unpacking Unpack the system and check that the following components are present and undamaged in the pack. If there is anything missing contact customer support.
Lactate Scout+ Analyzer / 1,5V AAA/LR03 batteries (2x) User manual
READ INSTRUCTIONS PRIOR TO USE
Onlyusethedeviceforthepurposedescribedinthismanual. Do not use any other accessories than those supplied by the manufacturer. Do not use the device in case of malfunction or damage. In case of non-intended use the safety measures for the device may become ineffective.
KEEP INSTRUCTIONS FOR USE
Not conforming to cautions may lead to serious health damage. Not conforming to information marked with “attention” may cause faulty measurements or damage of the device.
Contents
1. Getting started
Lactate Scout+ analyzer and sensors 6 Inserting the batteries 7 Code setting 8 Temperature sensor 9 Care and cleaning, Disposal 10
2. Taking a measurement
Inserting a sensor 12 Blood sampling 14
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3. Performing step tests
Settings for step tests 16 Afterload timer 18 Timing functions for step tests 18 Test results 19 Turning the device off 19 Deactivate the step test mode 19
4. Settings
Selecting and modifying settings 20
5. Data storage
Transferring data to the PC 23
6. Troubleshooting
Functionality check in dSC mode 26
Error description, potential causes and solutions 28
7. Technical specications
Parameters 32 Explanation of symbols 33
8. Accessories
Purchasing accessories 34
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Getting started
Lactate Scout+ analyzer
· Insertion slot (1) for the sensor
· Display window (2) for the display of test
readiness, the blood lactate concentration, warnings and setting options
· Scroll wheel (3) for easy operation of the
analyser. Scroll up and down to view menu options. Press the wheel to access the menu
Scrolling: Select option or search
Pressing: Activate/conrm selection or
deactivate/cancel selection
Turn on or off by pressing for 2 seconds
Lactate Scout+ sensor
· Measurement chamber (4) with opening for
the collection of the blood sample
· Connecting contacts (5) must be inserted
completely into the insertion slot of the measuring device with the black contact surface facing up
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1
2
3
4 5
Inserting the batteries
Batteries are included with your Lactate Scout+. Two LR03 / AAA (1.5 V) batteries must be
inserted prior to the initial use of your Lactate Scout+. Alkaline or zinc carbon batteries can
beused.Onlyusebatteriesofthesametype.
If the time to replace the batteries exceeds one minute, the date and time setting will be lost and must be re-entered (see page 20). The stored data and settings will be kept, however.
The Lactate Scout+ must be turned off to replace the batteries. Gently, push the battery cover outward. Remove the used batteries. When inserting the new batteries, ensure that the polarity is correct (+/-). The batteries must be inserted in the same direction. Push the battery cover back until it snaps into place.
Attention: In the case of prolonged periods
of non-use and when ying, the batteries must be removed.
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Please note: Used batteries must not be disposed of with household waste. Return them to the shop or any public collection point.
Getting started
Code setting
The rst time the Lactate Scout+ is used, a two-digit code must be set. This code is printed on the label of the sensor vial.
· Turn on the Lactate Scout+ device by
pressing the scroll wheel for two seconds. The request to set the code appears on the display(blinking)“setCODE”(1).
· After pressing the scroll wheel again briey,
the code setting menu is activated and the left code number will blink (2). Next, set the left digit listed under “code” on the sensor container by scrolling up or down and nally conrm by briey pressing the scroll wheel.
· To enter the right code digit, which will now
be blinking (3), repeat this process. The device is now coded (4).
The nalisation of coding is conrmed by a signal tone. To complete the process, insert a sensor or turn off the device.
Attention: Prior to using a new or other sensor
container, it is necessary to always check whether the code on the label corresponds to the current code in the device. If necessary, the latter must be reset.
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1 2
3 4
Temperature sensor
In order to be able to achieve equally reliable test values under different climatic conditions, the Lactate Scout+ is equipped with a temperature sensor. It is located underneath the insertion slot for the sensors.
The functionality of the temperature sensor impacts the establishment of test readiness as well as the achieved test values. Therefore, contamination must be avoided. To ascertain the ambient temperature, ensure that the temperature sensor is not touched by hand or covered.
The ambient temperature of the device can be displayed for 2 seconds by pressing the scroll wheel briey in test mode.
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Attention: Ensure that the measuring device
and sensors do not vary considerably from each other in temperature prior to a test (e.g. for winter sports or after storing the sensors in the refrigerator). If necessary, allow sufcient time for the temperature of the sensors and the measuring device to adjust.
Getting started
Care and cleaning
The Lactate Scout+ measuring device is an electronic precision measuring device and must be handled and stored with care. It must be protected from liquids, moisture, prolonged solar radiation and excessive effects of cold and heat (below 0°C and above +50°C).
Heavy mechanical loads, improper handling and contamination can partially or completely restrict functionality. Ensure that no liquid or dirt enters the inside of the device through the openings (insertion slot for sensor, scroll wheel and battery housing).
If blood, test solution, dust or other contaminants are present on the housing, it must be cleaned using a soft, lint-free towel or cellulose cloth (e.g. paper towel), which has been pre-soaked in a mild cleaning agent (e.g. water with a minimal amount of washing­up liquid), and then wiped dry. Medical staff should adhere to the regulations of the medical facility in this case.
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Never insert foreign objects or sensors other than Lactate Scout sensors into the insertion slot.
Disposal
In the case of blood lactate measurements it is impossible to exclude the possibility that the device will come into contact with blood. As a result, there is a risk of infection. Dispose of the device with household waste after removing the batteries.
(The device does not fall under the application of the European Directive 2002/96/EC regarding electrical and electronic equipment).
Attention: If the device housing is opened
by the user, this will invalidate all warranty and liability claims. Disinfecting agents containing isopropanol will result in the permanent tarnishing of the display window.
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