NOVA BIOMEDICAL LACTATE PLUS Instructions For Use Manual
  1. Manuals
  2. Brands
  3. NOVA BIOMEDICAL Manuals
  4. Measuring Instruments
  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

Instructions for Use Manual
i

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 1 Instructions for Use Manual...

  • Page 3: Table Of 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 Specifications ..........16 Disposal of Used Batteries and Meters for Customers in Europe ..........17...
  • Page 4 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...
  • Page 5 Cleaning and Disinfecting the Meter .......46 General Precautions for Cleaning and Disinfecting the Meter ................53 Error Messages ..............56 Codes ................56 Appendix................57 Specifications ..............57 Ordering Information ............59 Performance Characteristics ...........59 Accuracy .................60 Methodology ..............61 Precision .................62 Traceability ..............64 Instructional Notes ............66 Warranty ................70...

  • Page 7: Quick Reference Guide

    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 8 Quick Reference Guide Insert a Test Strip. Insert Test Strip: Automatic System Check begins. User Profile Number displays: use the left or right arrow button to select profile. Left Arrow MODE Right Arrow...
  • Page 9 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 single-use, disposable safety lancet against the pad of the finger, press the release button, remove the device from the finger.
  • Page 10 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 11: Symbols

    Symbols The following are symbols that are used in this manual, on insert sheets, and on the Lactate Plus Meter. Serial Number In vitro diagnostic medical device Temperature Limitation Authorized Representative Manufacturer in the European Date of Manufacture Community Contents...

  • Page 12: 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. The meter system is for in vitro diagnostic use only.

  • Page 13: Limitations

    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.

  • Page 14: Safety

    Safety 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.
  • Page 15 Safety Personnel operating this meter must be proficient 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.
  • Page 16 Safety 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.

  • Page 17: 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 18 Introduction LCD Display Mode Button Left Arrow Right Arrow Button Button Eject Button: Lactate Plus Bottom-Middle- Test Strip Back Lactate Plus Meter...
  • Page 19 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 20 Introduction Beeper ON Indicator Current Date/Day Current Time Display User Profile ICON Lactate Test Result User Profile Number (in mmol/L) Time of Test Date/Day of Test Test Result in Memory Indicator Lactate Plus Meter Screen...

  • Page 21: 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; touches the end of the test strip to the blood drop until the well of the test strip is full and the meter beeps;...

  • Page 22: Meter, Supplies, Transport Case

    Introduction Meter, Supplies, Transport Case The Nova Lactate Plus Meter (62623) comes in a soft carrying case that includes: 1. Lactate Plus Meter with Battery 2. Instructions for Use Manual See Page 59 for Ordering Information. Environmental Specifications • The meter operational temperature range for Lactate: 41°F to 113°F (5°C to 45°C)

  • Page 23: Disposal Of Used Batteries And Meters For Customers In Europe

    Disposal of Used Batteries and Meters for Customers in Europe • This symbol on the product label indicates that the product should not be treated as household waste. Batteries: To ensure the used battery is treated properly, remove the used battery from the product and hand over the used battery to the applicable collection point for the recycling of electrical and electronic equipment.

  • Page 24: Interfering Substances

    Introduction Interfering Substances Seventeen (17) interference compounds were studied to determine if their presence affected the reporting of lactate results in whole blood. None of the compounds interfered with the reporting of the Lactate Results at the tested con- centration range. Concentration Range Compound Tested...
  • Page 25 Introduction Concentration Range Compound Tested Ephedrine 0-0.8 mg/dL D-Glucose 0-900 mg/dL Ibuprofen 0-48 mg/dL L-Dopa 0-100 mg/dL Methyl-Dopa 0-1 mg/dL Salicylate 0-30 mg/dL Tetracycline 0-30 mg/dL Tolazamide 0-15 mg/dL Tolbutamide 0-45 mg/dL Tryglycerides 0-750 mg/dL Uric Acid 0-20 mg/dL...

  • Page 26: Setup

    Setup This section describes how to setup the Nova Lactate Plus Meter. The operator can set the meter for local time and date, have the beeper On or Off, enable the sample counter, and set the date display format. Installing the Battery (Replacing) The meter is powered by 2 AAA batteries.
  • Page 27 Setup CAUTION: Upon installing the battery, the meter software version displays for 3 seconds. Software versions may be numeric (example A1.0); therefore, please exercise caution to ensure the software version is not reported as a test result. 4. After the 3 seconds, the meter immediately goes to setup to configure the meter.

  • Page 28: Set The Date And Time

    Setup Set the Date and Time NOTE: While performing date and time setup, the selected item, hour or minute, day, month or year, will be flashing. Set Time Format 1. Press the MODE button for longer than 3 sec- onds. The meter, if in sleep mode, wakes up and enters the setup mode.
  • Page 29 Setup 3. Press the MODE button to accept the hour format. 4. The meter displays the current time or the default time with the hour digits flashing. Minutes Hour Hour Flashing Flashing Flashing 5. Press the left or right arrow button to set the hour.
  • Page 30 Setup 6. Press the MODE button to accept the displayed hour choice. The hour choice displays with the minute digits flashing. 7. Press the left or right arrow button to set the minutes. Scroll from 00 to 59 minutes. 8. Press the MODE button to accept the displayed minutes choice.

  • Page 31: Set Date Format

    Setup Set Date Format 1. Choose to have the date displayed as DD.MM or MM-DD. Press the left or right arrow button to toggle between the two choices.
  • Page 32 Setup 2. Press the MODE button to accept the displayed date format. The year should be flashing. 3. Press the left or right arrow buttons to select the current year. 4. Press the MODE button to accept the displayed Year. The month should be flashing. Month Flashing Year Flashing...
  • Page 33 Setup 5. Press the left or right arrow buttons to scroll through the 12 months (1 to 12). 6. Press the MODE button to accept the displayed Month. The day should be flashing. 7. Press the left or right arrow buttons to scroll through the days of the month.

  • Page 34: Beeper On Or Off

    Setup Beeper On or Off 1. Select the Left and Right Arrow buttons to toggle between Beeper ON or OFF (flashing). Flashing 2. Press the MODE button to accept the displayed ON or OFF.

  • Page 35: End Of Setup

    Setup End of Setup End displays with the entered date and time. Press the MODE button for 1.5 seconds to exit Setup or the meter will time out in 1 minute.

  • Page 36: 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 37 Only Nova Lactate Plus Lactate Control Solutions are recom- mended for use with the Lactate Plus Meter and the Lactate Plus Lactate Test Strips. Ranges for the Lactate Plus Meter us- ing other commercially available Lactate controls have not been...

  • Page 38: 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 left or right arrow buttons to find the de- sired control level: QC1...
  • Page 39 Testing: Blood and Quality Control Solutions 6. Remove the strip manually or use the ejector button on the back of the meter to eject the strip directly into a biohazard container. 7. The result is automatically stored into memory. 8. If this result is not needed, hold down the both the left and right arrow buttons for 2 seconds to enter...
  • Page 40 Testing: Blood and Quality Control Solutions delete single test mode (while the test strip is still in place). The delete icon flashes at the bottom of the screen. 9. Press the mode button to confirm deletion or press the left or right arrow button to stop deletion and exit the delete mode.

  • Page 41: Important Safety Instructions

    3. The Lactate Plus Meter may only be used for test- ing on multiple patients when standard precautions are followed and when the system is cleaned and disinfected after use on each patient following the procedure in the Appendix.
  • Page 42 Testing: Blood and Quality Control Solutions should wear a new pair of protective gloves before testing each new patient. 4. Only auto-disabling, single-use lancing devices may be used with this system. 5. For more information, refer to the following refer- ences: “Guideline for Isolation Precautions: Preventing Trans mission of Infectious Agents in Healthcare Settings 2007,”...

  • Page 43: 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 thoroughly with soap and water then dry thoroughly.
  • Page 44 Testing: Blood and Quality Control Solutions NOTE: Cleaning of the puncture site is important. Sweat left on the fingers may cause falsely high lactate test results. 5. Holding hand downward, massage finger with thumb toward tip to stimulate blood flow. 6.
  • Page 45 Testing: Blood and Quality Control Solutions 9. 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. NOTE: The on-screen Blood Drop flashes on and off repeat- edly until sufficient blood has been added to the test strip.
  • Page 46 Testing: Blood and Quality Control Solutions NOTE: While ejecting a test strip, care should be exer- cised not to point ejected strips anywhere other than a biohazard container. 13. The result is automatically stored into memory. 14. If the result is not needed, press both the left right arrow buttons for 2 seconds to go to delete mode (while the test strip is still in place).
  • Page 47 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 48 Testing: Blood and Quality Control Solutions Profile Number Lactate Result Date Time Lactate Plus Meter with Display Results...
  • Page 49 Testing: Blood and Quality Control Solutions If the result is LO (less than the measurement range) or HI (greater than the measurement range) repeat the test. LO and HI Result Screens...

  • Page 50: 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 51 Data Review NOTE: When there are no results in the user profile, the monitor will display three dashes (---). 4. Press the right arrow button once to view the aver- age of the test results for the selected user or the con- trol level.

  • Page 52: Basic Upkeep

    Disin- fecting means to kill or prevent the growth of disease- carrying micro organisms. The Nova Lactate Plus Meter should be cleaned and disinfected after each patient use over the intended 3 year use-life of the Meter.
  • Page 53 Basic Upkeep Procedure 1 The Nova Lactate Plus Meter cleaning and disinfecting procedure was validated a total of 10,950 times by Nova Biomedical to simulate 3 year use-life of the Monitor. The validation testing corresponded to cleaning and disinfecting 10 times a day for 3 years.
  • Page 54 Disinfecting means to kill or prevent the growth of disease carrying microorganisms. The Nova Lactate Plus Meter should be cleaned and disinfected after each patient use to minimize the risk of transmission of blood-borne pathogens between patients and healthcare professionals.
  • Page 55 Basic Upkeep NOTE: To properly clean and disinfect the Meter, steps 1 to 5 should be performed together before testing on each patient. 1. Clean the Meter. • Wipe the external surface of the Meter thoroughly with a fresh Germicidal Wipe. •...
  • Page 56 Basic Upkeep 3. Observe surface contact time. • Ensure the Meter surface stays wet for the recommended time and is allowed to air dry for an additional 1 minute. NOTE: If you must rewet the surface of the Meter, use a new, fresh wipe. 4.
  • Page 57 Basic Upkeep Alternate Procedure When cleaning the meter, please follow the guidelines listed below: • Always apply the cleaning agent to a soft cloth to wipe the meter surface. Once complete, immediately dry thoroughly. • The meters should never be immersed in any cleaning agent.
  • Page 58 Basic Upkeep • Avoid harsh solvents such as benzene and strong acids. • Care should be used to limit exposing test ports to flu- ids as it may result in damage to the unit.

  • Page 59: General Precautions For Cleaning And Disinfecting The Meter

    Your warranty and all claims will be void! Only Nova Biomedical authorized service personnel can repair the meter. Call Nova Biomedical or an authorized dealer if the meter needs to be repaired or checked. Healthcare professionals and others should follow Good Laboratory Practice guidelines and these important safety instructions.
  • Page 60 Healthcare professionals should ensure they are wearing protective gloves when disinfecting the meter and should wash their hands thoroughly with soap and water after han- dling the meter. NOTE: Cleaning and disinfection may in rare cases damage the device(s). Meter damage may include plastic housing cracks, cloudiness, or frosting of the display, legibility or response issues with the keypad, or battery compartment fluid leakage.
  • Page 61 The next section addresses the messages that appear on your displays, what they mean, and what action you need to take.

  • Page 62: 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 63: Appendix

    Appendix Specifications Tests Measured Blood Lactate Lactate Methodology Lactate oxidase biosensor Lactate Test Results mmol/L Sample Type Whole blood (capillary or venous) Lactate Test Range 0.3 to 25.0 mmol/L Limit of Detection 0.12 mmol/L Limit of Quantitation 0.12 mmol/L Test Time 13 seconds Test Strip Volumes 0.7 µL...
  • Page 64 Appendix Operating Ranges: Temperature Range 41° to 113°F (5° to 45°C) Humidity 10% to 90% relative humidity Weight 2.77 oz (78.5 g) Size 3.9x2.4x0.9 in (98.0x61.0x22.9 mm) On-board data storage files: User profile P-0 can store up to 20 test results. P-1 to P-9 each can store up to 10 test results.

  • Page 65: Ordering Information

    Appendix Ordering Information Supplies and parts for the Lactate Plus Meter System are available from Nova Biomedical. DESCRIPTION ............Vial of Test Strips (25) ..........40813 Lactate Plus Control Solution, Level 1 ....40815 Lactate Plus Control Solution, Level 2 ......40814 Battery (2 AAA) ............

  • Page 66: Accuracy

    Appendix Accuracy Accuracy of the Lactate Plus Meter system (Lactate Plus Mono- chrome) was assayed at clinical sites by comparing lactate re- sults 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 67: Methodology

    Appendix Methodology The Lactate measurement is based on the following methodology: L-Lactate + LOD –––> Pyruvate + LOD Equation 1 + Fe(CN) –––> LOD + Fe(CN) Equation 2 Fe(CN) —————> Fe(CN) Electrode Equation 3 The current generated at the electrode is proportional to the Lactate concentration of the sample.

  • Page 68: Precision

    Appendix Precision Precision of Nova Lactate Plus Meter was measured with both venous blood samples and control solution in laboratory. The results for the blood samples are shown below: Summary of Lactate Plus Within-Run Precision - Blood Results Lactate Blood Level...
  • Page 69 Summary of Within-Run Precision - Control Solution Results Lactate Lactate Lactate Aqueous Aqueous Aqueous Level 1 Level 2 Level 3 (N=20) (N=20) (N=20) Mean 14.0 Lot 1 SD (mmol/L) 0.05 0.09 0.20 Mean 14.0 Lot 2 SD (mmol/L) 0.06 0.12 0.14...

  • Page 70: Traceability

    Day to Day Precision - Control Solution Results Lactate Lactate Lactate Aqueous Aqueous Aqueous Level 1 Level 2 Level 3 (N=20) (N=20) (N=20) Mean 14.1 Lot 1 4.74 3.46 1.78 SD (mmol/L) 0.06 0.16 0.25 Traceability Analyte is traceable to the Nova L-Lactate Primary Standard (L-Lactate: Sigma CAS 27848-80-2).
  • Page 71 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 72: Instructional Notes

    Appendix Instructional Notes 1. Inserting a test strip overrides all other modes except Upload mode. 2. There is no “All segments Screen” in Upload mode. 3. When in Upload mode, no other meter functions are available, and there is no response by meter to button presses.
  • Page 73 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 74 Appendix 13. The Meter responses to the pressing and the holding of keys: Left or Right Arrow buttons Use the left or right arrow buttons to scroll through the user’s test results. In cases where the arrow buttons move forward through a series of stored test results or increment- ing a value, hold down the left or right arrow button to advance to the next screen.
  • Page 75 Appendix While meter is awake (ON), pressing the MODE button > 1.5 seconds manually turns off the meter (sleep mode). While meter is in sleep mode (OFF), pressing the MODE button < 1.5 seconds wakes up the meter and enters data review mode. While meter is in sleep mode (OFF), pressing the MODE button >...

  • Page 76: 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 77 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 78 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 79 For technical assistance outside the United States, call your local Nova subsidiary or authorized distributor. Nova Biomedical recommends users report any serious incidents/adverse events back to Nova Biomedical or to Nova Biomedical’s Authorized Representative as well as to their local Competent Authority as required. Nova Biomedical Canada Ltd.
  • Page 80 Nova Biomedical GmbH Hessenring 13A, Geb. G Nova Biomedical Diagnósticos Médicos 64546 Mörfelden-Walldorf, e Biotecnologia Ltda Nova Biomedical Brazil Germany Rua Massena, 107, JardimCanadá Tel: + 49 (0) 61054505-0 Nova Lima – MG – Cep: 34007-746 Tel: (55) 31 3360-2500 Nova Biomedical KK sac@novabiomedical.com.br...
  • Page 81 Nova Biomedical Telephone: 1-800-350-5024 200 Prospect Street Technical Support hours: 9AM to 5PM EST Waltham, MA 02454-9141 1-781-894-0800 U.S.A. Fax: 1-781-894-5915 Web: www.novalactate.com Made in the USA by Nova Biomedical Corporation Copyright 2022 Nova Biomedical Corporation 62659B 06.2022...

Table of Contents