NOVA BIOMEDICAL Lactate Plus Instructions For Use Manual
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NOVA BIOMEDICAL Lactate Plus Instructions For Use Manual

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Lact Plus Meter PN 62659A84.indd 1
Lact Plus Meter PN 62659A84.indd 1
Instructions for Use Manual
i
11/18/19 5:11 PM
11/18/19 5:11 PM

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  • Page 1 Instructions for Use Manual Lact Plus Meter PN 62659A84.indd 1 Lact Plus Meter PN 62659A84.indd 1 11/18/19 5:11 PM 11/18/19 5:11 PM...
  • Page 2 Lact Plus Meter PN 62659A84.indd 2 Lact Plus Meter PN 62659A84.indd 2 11/18/19 5:11 PM 11/18/19 5:11 PM...

  • Page 3: Table Of Contents

    Quick Reference Guide ............1 Symbols .................5 Intended Use .................6 Warnings, Cautions, and Notes ..........7 Introduction ................9 The Lactate Plus Meter .............9 Overview .................13 Meter, Supplies, Transport Case ........14 Environmental Specifications ..........14 Disposal of Used Batteries ..........15 Disposal of Used Meters ..........15 Interfering Substances ............16...
  • Page 4 Setup ...................18 Installing the Battery (Replacing) ........18 Set the Date and Time ............20 Set Time Format ..............20 Set Date Format ..............23 Beeper On or Off .............26 End of Setup ..............27 Testing: Blood and Quality Control Solutions ......28 Testing a Quality Control Solution ........30 Important Safety Instructions ..........32 Testing a Blood Sample ..........35 Data Review ................41...
  • Page 5 Basic Upkeep ..............43 Cleaning and Disinfecting the Meter .......43 General Precautions for Cleaning and Disinfecting the Meter ................50 Error Messages ..............53 Codes ................53 Appendix................54 Specifications ..............54 Accessories: ..............56 Performance Characteristics ...........56 Accuracy .................57 Precision .................58 Instructional Notes ............60 Warranty ................64 Lact Plus Meter PN 62659A84.indd 3 Lact Plus Meter PN 62659A84.indd 3 11/18/19 5:11 PM...
  • Page 6 Lact Plus Meter PN 62659A84.indd 4 Lact Plus Meter PN 62659A84.indd 4 11/18/19 5:11 PM 11/18/19 5:11 PM...

  • Page 7: Quick Reference Guide

    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. Nova Biomedical recommends the use of a 21 gauge, single use, disposable safety lancet for capillary blood sampling.
  • 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 Lact Plus Meter PN 62659A84.indd 2 Lact Plus Meter PN 62659A84.indd 2 11/18/19 5:11 PM 11/18/19 5:11 PM...
  • 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 auto-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. Lot Number In vitro diagnostic medical device Electronic Waste Authorized Representative in the European Community Product fulfills the requirements Catalog number...

  • 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.

  • Page 13: Warnings, Cautions, And Notes

    Warnings, Cautions, and Notes 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. Lact Plus Meter PN 62659A84.indd 7 Lact Plus Meter PN 62659A84.indd 7 11/18/19 5:11 PM 11/18/19 5:11 PM...
  • Page 14 Lact Plus Meter PN 62659A84.indd 8 Lact Plus Meter PN 62659A84.indd 8 11/18/19 5:11 PM 11/18/19 5:11 PM...

  • Page 15: 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 small parts being swallowed.
  • Page 16 Introduction LCD Display Mode Button Left Arrow Right Arrow Button Button Eject Button: Lactate Plus Bottom-Middle- Test Strip Back Lactate Plus Meter Lact Plus Meter PN 62659A84.indd 10 Lact Plus Meter PN 62659A84.indd 10 11/18/19 5:11 PM 11/18/19 5:11 PM...
  • Page 17 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 18 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 Lact Plus Meter PN 62659A84.indd 12 Lact Plus Meter PN 62659A84.indd 12 11/18/19 5:11 PM 11/18/19 5:11 PM...

  • Page 19: 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 20: Meter, Supplies, Transport Case

    Introduction Meter, Supplies, Transport Case The Nova Lactate Plus Meter (62623) comes in a soft carry- ing case that includes: 1. Lactate Plus Meter with Battery 2. Instructions for Use Manual See Page 56 for a listing of supplies and accessories.

  • Page 21: Disposal Of Used Batteries

    Introduction Disposal of Used Batteries • Remove the used batteries from the meter and hand over the used batteries to the applicable collection point for the recycling of electrical and electronic equipment. Disposal of Used Meters • The meter may become infectious during the course of use.

  • Page 22: 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 23 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 Lact Plus Meter PN 62659A84.indd 17 Lact Plus Meter PN 62659A84.indd 17 11/18/19 5:11 PM 11/18/19 5:11 PM...

  • Page 24: Installing The Battery (Replacing)

    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 25 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 26: 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 27 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 28 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 29: 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. Lact Plus Meter PN 62659A84.indd 23 Lact Plus Meter PN 62659A84.indd 23 11/18/19 5:11 PM 11/18/19 5:11 PM...
  • Page 30 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 Lact Plus Meter PN 62659A84.indd 24...
  • Page 31 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 32: 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. Lact Plus Meter PN 62659A84.indd 26 Lact Plus Meter PN 62659A84.indd 26 11/18/19 5:11 PM 11/18/19 5:11 PM...

  • Page 33: 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. Lact Plus Meter PN 62659A84.indd 27 Lact Plus Meter PN 62659A84.indd 27 11/18/19 5:11 PM 11/18/19 5:11 PM...

  • Page 34: 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 35 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 established.

  • Page 36: 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 arrow buttons to find the de- or right sired control level: QC1...
  • Page 37 Testing: Blood and Quality Control Solutions 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 delete single test mode.

  • Page 38: Important Safety Instructions

    Testing: Blood and Quality Control Solutions Important Safety Instructions Standard Precautions should be adhered to when handling or using the Nova Lactate Plus Meter to reduce the risk of disease transmission. All parts of the Nova Lactate Plus Meter are considered po- tentially infectious and can potentially transmit blood-borne pathogens between patients and healthcare professionals.
  • Page 39 Testing: Blood and Quality Control Solutions Healthcare professionals should wear a new pair of protec- tive gloves before testing each new patient. For more information, refer to the following references: • “Guidline for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings 2007,” http:// www.cdc.gov/hicpac/2007ip/2007isolationprecautons.html.
  • Page 40 Testing: Blood and Quality Control Solutions • “FDA Public Health Notification: Use of Fingerstick Devices on More than One Person Poses Risk for Transmitting Bloodborne Pathogens: Initial Communication.” (2010) http://www.fda.gov/Medicaldevices/Safety/AlertsandNo- tices/ucm224025.html. • “CDC Clinical Reminder: Use of Fingerstick Devices on More than One Person Poses Risk for Transmitting Bloodborne Pathogens.”...

  • Page 41: 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 42 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 43 Testing: Blood and Quality Control Solutions 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. 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.
  • Page 44 Testing: Blood and Quality Control Solutions mode (while the test strip is still in place). The delete flashes at the bottom of the screen. icon button to confirm deletion or press 15. Press the MODE the left or right arrow button to stop deletion and exit the delete mode.
  • Page 45 Testing: Blood and Quality Control Solutions Profile Number Lactate Result Date Time Lactate Plus Meter with Display Results Lact Plus Meter PN 62659A84.indd 39 Lact Plus Meter PN 62659A84.indd 39 11/18/19 5:11 PM 11/18/19 5:11 PM...
  • Page 46 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 Lact Plus Meter PN 62659A84.indd 40 Lact Plus Meter PN 62659A84.indd 40 11/18/19 5:11 PM 11/18/19 5:11 PM...

  • Page 47: 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 48 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 49: 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 50 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 51 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 52 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 53 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 54 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 55 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. Lact Plus Meter PN 62659A84.indd 49 Lact Plus Meter PN 62659A84.indd 49 11/18/19 5:11 PM 11/18/19 5:11 PM...

  • Page 56: 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 57 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 Lact Plus Meter PN 62659A84.indd 51 Lact Plus Meter PN 62659A84.indd 51...
  • Page 58 response issues with the keypad, or battery compartment fluid leakage. Signs of Meter performance deterioration may include failure to recover proper control results or the inability to perform a blood test. If you observe damage due to cleaning and disinfecting, please stop using the Meter and contact Customer Service.

  • Page 59: 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 60: 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 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 61 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 62: Accessories

    Lactate Plus Control Solution, Level 2 (REF 40814) Battery (2 AAA) (REF 57081) Soft Carrying Case (41266) Performance Characteristics The test measurement range for Nova Lactate Plus Meter is 0.3 to 25.0 mmol/L for Lactate. Lact Plus Meter PN 62659A84.indd 56 Lact Plus Meter PN 62659A84.indd 56...

  • Page 63: Accuracy

    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 64: Precision

    Appendix Precision Precision of Nova Lactate Plus Meter was measured with both venous blood samples and control solution in labora- tory. The results for the blood samples are shown below: Lactate Level Lactate Mean (mmol/L) 11.7 16.5 20 measurements S.D. (mmol/L) 0.11...
  • Page 65 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 66: 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 67 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 68 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 69 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 70: 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 71 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 72 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 GOODS FOR WHICH THE LIABILITY IS CLAIMED.
  • Page 73 Hessenring 13A, Geb. G Fax: +49 6105 4505-37 64546 Mörfelden-Walldorf Germany For technical assistance outside the United States, call your local Nova subsidiary or authorized distributor. Nova Biomedical Canada Ltd. Nova Biomedical UK Nova Biomedical KK 2900 Argentia Road Innovation House Mita43MT Bldg-7F...
  • Page 74 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 2019 Nova Biomedical Corporation 62659A 08.2019 Lact Plus Meter PN 62659A84.indd 68 Lact Plus Meter PN 62659A84.indd 68 11/18/19 5:11 PM 11/18/19 5:11 PM...

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