NOVA BIOMEDICAL LACTATE PLUS Instructions For Use Manual
  1. Manuals
  2. Brands
  3. NOVA BIOMEDICAL Manuals
  4. Medical Equipment
  5. Lactate Plus
  6. Instructions for use manual

NOVA BIOMEDICAL LACTATE PLUS Instructions For Use Manual

Hide thumbs Also See for LACTATE PLUS:
Table of Contents

Advertisement

Quick Links

Advertisement

Table of Contents
loading
Need help?

Need help?

Do you have a question about the LACTATE PLUS and is the answer not in the manual?

Questions and answers

Subscribe to Our Youtube Channel

Related Manuals for NOVA BIOMEDICAL LACTATE PLUS

Summary of Contents for NOVA BIOMEDICAL LACTATE PLUS

  • Page 2: Table Of Contents

    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...
  • Page 3 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...
  • Page 4 Quick Reference Guide 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.
  • Page 5 Quick Reference Guide Insert a Test Strip. Insert Test Strip: Automatic System Check begins. User Profile Number displays: use Search key to select profile. SEARCH SELECT MODE...
  • Page 6 Quick Reference Guide 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.
  • Page 7 Quick Reference Guide 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.

  • Page 8: Intended Use

    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.

  • Page 10: Symbols

    Symbols The following are symbols that are used in this manual, on insert sheets, and on the Lactate Plus Meter. In vitro diagnostic medical Catalog number device Fulfills requirements of Temperature limitation Directive 98/79 EC (IVDD) Caution, consult accompanying documents...

  • Page 11: Warnings, Cautions, And Notes

    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.

  • Page 12: Introduction

    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...
  • Page 13 Introduction Lactate Plus Test Strip LCD Display Select Search Button Button Mode Button Lactate Plus Meter...
  • Page 14 Introduction 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.
  • Page 15 User Profile Number User Profile ICON Quality Control Indicator Lactate Test Result (in mmol/l) Test Result in Low Battery Memory Indicator Indicator Average Test Result Blood or Control Drop Indicator AM or PM Indicator Date/Day Hour/Minute Lactate Plus Meter Screen...

  • Page 16: Overview

    Introduction 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;...

  • Page 17: Meter, Supplies, Transport Case

    Introduction 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.

  • Page 18: Environmental

    Introduction 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) •...

  • Page 19: Setup

    Setup 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.
  • Page 20 Setup • 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.
  • Page 21 Setup 1a. Select 12 Hour, then select 2. Select minutes. hour with AM/PM. 1b. Or Select 24 Hour, then select hour.

  • Page 22: Set Date Format

    Setup Set Date Format • After the time has been set up, set date format is next. The display is 12-31 2004 or 31.12 2004. • You can choose to have the date as DD.MM or MM-DD. These digits will be flashing until selected. Press the SEARCH button to toggle between DD.MM or MM- •...
  • Page 23 Setup • The date is displayed as selected in the date format: either DD.MM or MM-DD. • Press the SEARCH button to progress through the 12 months (1 to 12). The 2 month numbers will be flashing. • Press the SELECT button to select the displayed Month choice.
  • Page 24 Setup 3. Select Date format: 4. Select Year with MM-DD or DD.MM. Search button. 5. Select Month. 6. Select Day.

  • Page 25: Beeper On Or Off

    Setup Beeper On or Off • Next is the Beeper on or off. Press the SEARCH button to toggle between ON and OFF (flashing). • Press the SELECT button to select the displayed ON or OFF choice. 7. Select Beeper ON or Beeper OFF.

  • Page 26: End Of Setup

    Setup End of Setup • The screen displays END. • Press the MODE button for 1.5 seconds to save the setup configuration. • The meter will power down. The new settings will be ap- plied once the meter is powered back up. 8.

  • Page 27: Testing: Blood And Quality Control Solutions

    You should run a control solution test: • Before using your Nova Lactate Plus Meter for the first time and at least once a week thereafter • Each time you open a new box of Nova Lactate Test Strips •...

  • Page 28: Testing A Quality Control Solution

    Testing: Blood and Quality Control Solutions Testing a Quality Control Solution 1. Grasp a test strip with logo side up and gold side down. Then insert the gold end into the meter. (See Meter figure.) 2. Identify the sample as a control; use the SEARCH button to find the desired control level: CrL 1 or CrL 2. 3. Shake the control solution well before each use. Discard the first drop. 4. Place a drop of control solution from the bottle at the end of the test strip until the solu- tion is drawn into the well of the test strip. NOTE: The on-screen Control Drop flashes on and off repeatedly until sufficient control solution has been added to the test strip.
  • Page 29 Testing: Blood and Quality Control Solutions 5. A Lactate quality control test result is available on- screen in 13 seconds. 6. The result is automatically stored into memory. 7. If this result is not needed, press the SELECT but- ton for 2 seconds to go to dELEtE (flashes) mode (while the test strip is still in place).

  • Page 30: Testing A Blood Sample

    Testing: Blood and Quality Control Solutions Testing a Blood Sample NOTE: The hands should be warm and relaxed. Obtain blood sample from a finger. 1. Check that the expiration date of the test strips has not elapsed. 2. Wash hands with water then dry thoroughly. Alternatively, use alcohol pads to clean area 3 times;...
  • Page 31 Testing: Blood and Quality Control Solutions 5. Holding hand downward, massage finger with thumb toward tip to stimulate blood flow. 6. Use the lancet to puncture the finger. 7. Wipe off the first drop with a clean tissue. The first drop may be contaminated.
  • Page 32 Testing: Blood and Quality Control Solutions 10. If subject has to immediately return to exercise and puncture site is still bleeding, apply light pressure with a cotton pad or tissue until the bleeding stops or cover with a bandage. 11. The Lactate result is available on-screen in 13 seconds. 12.
  • Page 33 Testing: Blood and Quality Control Solutions WARNING: Once a disposable item, i.e., lancet, test strip, alcohol swab, etc., has been used, it is consid- ered contaminated. Dispose of all contaminated mate- rials in accordance with local regulations. Equipment such as lancets and tissues must be used only once and then disposed of even when repeated measure- ments are being made on the same subject.
  • Page 34 Testing: Blood and Quality Control Solutions Profile Number Lactate Result Date Time Lactate Plus Meter with Display Results...

  • Page 35: Data Review

    Data Review Data Review NOTE: If a test strip is inserted while in the Data Review mode, the meter immediately switches to test mode. If you then exit the test mode, the meter screen goes blank- the meter does not return to the Data Review mode. Manually Reviewing Stored Test or Control Results 1.
  • Page 36 4. Press the MODE button to advance to the user profile (P0 to P9) or control level (*1 or *2) that you want to review. 5. Press the SEARCH button to review the test results for the selected user or the control level.

  • Page 37: Battery Replacement

    Basic Upkeep Battery Replacement The meter is powered by a single 3V coin cell battery, 2450. Replace the battery as follows: 1. Remove the back battery cover on the meter. Low Battery 2. Remove the battery and re- place with a new one with the + side facing up.

  • Page 38: Cleaning And Care

    Basic Upkeep Cleaning and Care If necessary, clean the Lactate Plus Meter with a clean cloth dampened with water. Keep liquids from entering the test strip port or the Search, Enter, and Mode buttons. CAUTION: Do Not attempt to open the Lactate Plus Meter to make any repairs.

  • Page 39: Error Messages

    Error Messages Codes Code Alerts Action Software error detected Perform the test again. If you get the same error, call Nova Technical Support. Hardware error detected Perform the test again. If you get the same error, call Nova Technical Support. Meter temperature is outside Move the meter to an area of the range for testing...

  • Page 40: Appendix

    Appendix Specifications Tests Measured Blood Lactate Lactate Methodology Lactate oxidase biosensor Lactate Test Results mmol/l (Plasma values) Sample Type Whole blood Lactate Test Range 0.3 to 25.0 mmol/l Test Time 13 seconds Test Strip Volumes 0.6 µl Battery Life (nominal) 600 Tests Data Output Port Serial...
  • Page 41 Appendix Operating Ranges: Temperature Lactate 41° to 113°F (5° to 45°C) Humidity 10% to 90% relative humidity Weight 2.65 oz (75 g) Size 3.6x2.3x0.9 in (91.4x58.4x22.9 mm) On-board data storage files: 1 common file for 20 tests 9 additional user files for 10 tests each 2 control files, 10 tests each...

  • Page 42: Performance Characteristics

    Lactate Plus Control Solution, Level 2 (REF 40814) PC Data Communication (upload) Cable (REF 41235) Soft Carrying Case (41266) Battery (DL2450) (REF 41221) Performance Characteristics The test result range for Nova Lactate Plus Meter is 0.3 to 25.0 mmol/l for Lactate.

  • Page 43: Accuracy

    Appendix Accuracy Accuracy of the Lactate Plus Meter system was assayed at clinical sites by comparing lactate results obtained by Lactate Plus Meter vs YSI Reference method from subjects at clinical sites. Blood lactate measurements obtained from Nova Lactate Plus Meter were compared with the same subjects’...

  • Page 44: Precision

    Appendix Precision Precision of Nova Lactate Plus Meter was measured with both ve- nous blood samples and control solution in laboratory. The results are shown below: Lactate Level Lactate Mean (mmol/l) 10.8 18.1 22.1 20 measurements S.D. (mmol/l) 0.06 0.12 0.17...
  • Page 45 Appendix References Clark, L.C. Jr, Noyes, L.K., Grooms, T.A., Moore, M.S.1984. Rapid Micromeasurement of Lactate in Whole Blood: Critical Care Medicine. Vol. 12 pp 481-464. Hirano, K., Yamato, N., Kunimoto, K., and Ohwa, M. 2001. Novel Electron Transfer mediators Based on Dichloroindophenol Derivatives for Lactate Oxidase: Journal Electroanalytical Chemistry.

  • Page 46: Instructional Notes

    Appendix Instructional Notes 1. Inserting a test strip overrides all other modes. 2. There is no “All segments Screen” in Upload mode. 3. When in Upload mode, no other meter functions are avail- able, and there is no response by meter to button presses.
  • Page 47 Appendix 7. If in Data Review mode when the test strip is inserted, the meter immediately switches to test mode. Upon exit- ing test mode the meter screen goes blank and does not return to Data Review mode. 8. Battery low icon is displayed in every mode except setup. 9.
  • Page 48 Appendix 12. The Meter responses to the pressing and the holding of keys: SEARCH key The Meter responds immediately after the SEARCH key is pressed. In cases where the SEARCH key moves forward through a series of stored test result screens or increments a value, hold down the SEARCH key to speed up screen change process.
  • Page 49 Appendix While meter is in sleep mode (OFF), pressing the MODE button > 3.0 seconds wakes up the meter and enters setup mode. While meter is awake (ON), pressing the MODE button > 1.5 seconds manually turns off the meter (sleep mode).

  • Page 50: Warranty

    Warranty Subject to the exclusions and upon the conditions specified below, Nova Bio- medical or the authorized Nova Biomedical distributor warrants that he will correct free of all charges including labor, either by repair, or at his election, by replacement, any part of an instrument which fails within one (1) year from date of shipment because of defective material or workmanship.
  • Page 51 All requests for war- ranty replacement must be received by Nova or their authorized distributor within thirty (30) days after the component failure. Nova Biomedical reserves the right to change, alter, modify or improve any of its instruments without any obligation to make corresponding changes to any instrument previously sold or shipped.
  • Page 52 CONNECTION WITH THE SALE OR FURNISHING OF GOODS OR PARTS, THEIR DESIGN, SUITABILITY FOR USE, INSTALLATION OR OPERATION. NOVA BIOMEDICAL WILL IN NO EVENT BE LIABLE FOR ANY SPECIAL OR CONSEQUENTIAL DAMAGES WHATSOEVER, AND OUR LIABILITY UNDER NO CIRCUMSTANCES WILL EXCEED THE CONTRACT PRICE FOR THE...
  • Page 55 Telephone: 1-800-350-5024 200 Prospect Street 1-781-894-0800 Waltham, MA 02454-9141 Fax: 1-781-894-5915 U.S.A. Web: www.novalactate.com U.S. Patent Nos. 6,258,229, 6,287,451, and 6,837,976 (Additional Foreign Patents apply) Made in the USA by Nova Biomedical Corporation Copyright 2006 Nova Biomedical Corporation 41293B 01.2007...

This manual is also suitable for:

41293b

Table of Contents

Save PDF