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

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Instructions for Use Manual
NOVA Lact Plus Meter PN 41293D.indd 1
6/12/18 8:50 AM

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  • Page 1 Instructions for Use Manual NOVA Lact Plus Meter PN 41293D.indd 1 6/12/18 8:50 AM...
  • Page 2 NOVA Lact Plus Meter PN 41293D.indd 2 6/12/18 8:50 AM...

  • Page 3: Table Of Contents

    Quick Reference Guide ..............1 Intended Use ..................5 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 End of Setup ................23...
  • Page 4 Testing a Blood Sample ..............30 Data Review ...................35 Data Review................35 Manually Reviewing Stored Test or Control Results ....35 Battery Replacement ..............37 Cleaning and Disinfecting the Meter ...........38 Disposal of Used Batteries for Customers in Europe....44 Disposal of Used Meters for Customers in Europe .....44 Error Messages ................45 Codes, Alerts, Actions ..............45 Appendix..................46...
  • Page 5 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 6 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 NOVA Lact Plus Meter PN 41293D.indd 2 6/12/18 8:50 AM...
  • Page 7 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 8 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 9: 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 NOVA Lact Plus Meter PN 41293D.indd 6 6/12/18 8:50 AM...

  • Page 11: 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 Lot Number device Authorized Representative Electronic Waste in the European Community Product fulfills the requirements Catalog number...

  • Page 12: 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. NOVA Lact Plus Meter PN 41293D.indd 8 6/12/18 8:50 AM...

  • Page 13: 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 14 Introduction Lactate Plus Test Strip LCD Display Select Search Button Button Mode Button Lactate Plus Meter NOVA Lact Plus Meter PN 41293D.indd 10 6/12/18 8:50 AM...
  • Page 15 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 16 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 NOVA Lact Plus Meter PN 41293D.indd 12 6/12/18 8:50 AM...

  • Page 17: 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 18: 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 48 for a listing of supplies and accessories.

  • Page 19: 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 20: 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 21 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 22 Setup 1a. Select 12 Hour, then select 2. Select minutes. hour with AM/PM. 1b. Or Select 24 Hour, then select hour. NOVA Lact Plus Meter PN 41293D.indd 18 6/12/18 8:50 AM...

  • Page 23: 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 24 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 25 Setup 3. Select Date format: 4. Select Year with MM-DD or DD.MM. Search button. 5. Select Month. 6. Select Day. NOVA Lact Plus Meter PN 41293D.indd 21 6/12/18 8:50 AM...

  • Page 26: 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. NOVA Lact Plus Meter PN 41293D.indd 22 6/12/18 8:50 AM...

  • Page 27: 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 28: 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 29: 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.
  • Page 30 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 31: 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 32 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 33 Testing: Blood and Quality Control Solutions • “FDA Public Health Notification: Use of Fingerstick Devices on More than One Person Poses Risk for Tranmitting Blood- borne Pathogens: Initial Communication.” (2010) http:// www.fda.gov/Medicaldevices/Safety/AlertsandNotices/ ucm224025.html. • “CDC Clinical Reminder: Use of Fingerstick Devices on More than One Person Poses Risk for Transmitting Bloodborne Pathogens.”...

  • Page 34: 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 35 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 36 Testing: Blood and Quality Control Solutions 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 37 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 38 Testing: Blood and Quality Control Solutions Profile Number Lactate Result Date Time Lactate Plus Meter with Display Results NOVA Lact Plus Meter PN 41293D.indd 34 6/12/18 8:50 AM...

  • Page 39: 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 40 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. NOVA Lact Plus Meter PN 41293D.indd 36 6/12/18 8:50 AM...

  • Page 41: 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 42: Cleaning And Disinfecting The Meter

    The Nova Lactate Plus Meter should be cleaned and disinfected after each patient use over the intended 3 year use-life of the Meter. 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 Meter.
  • Page 43 Disinfecting means to kill or prevent the growth of disease carrying microorganisms. The Nova Lactate Plus Meter should be cleaned and disin- fected after each patient use to minimize the risk of trans- NOVA Lact Plus Meter PN 41293D.indd 39...
  • Page 44 Basic Upkeep mission of blood-borne pathogens between patients and healthcare professionals. Healthcare professionals and others should follow Good Labora- tory Practice guidelines and these important safety instructions. 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.
  • Page 45 Basic Upkeep 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. Signs of Meter performance deterioration may include failure to recover proper control results or the inability to perform a blood test.
  • Page 46 Basic Upkeep 1. Clean the Meter. • Wipe the external surface of the Meter thoroughly with a fresh Germicidal Wipe. • Discard the used wipe per Step 4. 2. Disinfect the Meter. • Remove another fresh Clorox Germicidal Wipe from the canister.
  • Page 47 Basic Upkeep NOTE: If you must rewet the surface of the Meter, use a new, fresh wipe. 4. Dispose of wipes • Dispose of the used germicidal wipes in a standard waste container. 5. Wash and sanitize hands. • Wash your hands thoroughly with soap and water.

  • Page 48: Disposal Of Used Batteries For Customers In Europe

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

  • Page 49: Error Messages

    Error Messages This section addresses the messages that appear on your displays, what they mean, and what action you need to take. 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.

  • Page 50: 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 0.6 µL...
  • Page 51 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 NOVA Lact Plus Meter PN 41293D.indd 47 6/12/18 8:50 AM...

  • Page 52: Performance Characteristics

    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. NOVA Lact Plus Meter PN 41293D.indd 48 6/12/18 8:50 AM...

  • Page 53: 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 lac- tate measurements obtained from Nova Lactate Plus Meter were compared with the same subjects’...

  • Page 54: 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 55 Appendix References Goldman, Lee, and Schafer, Andrew I. Goldman-Cecil Medicine, 25th Edition. Copyright @ 2016. (27 Apr 2015). ISBN 978145570177. E- ISBN 9780323322867. Goodwin, Matthew L., Harris, James E., Hernández, Andrés, and Gladden, L. Bruce. Blood Lactate Measurements and Analysis during Exercise: A Guide for Clinicians.

  • Page 56: 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 57 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 58 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 59 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 60: 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 61 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 62 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 63 NOVA Lact Plus Meter PN 41293D.indd 59 6/12/18 8:50 AM...
  • Page 64 Fax: 1-781-894-5915 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 2018 Nova Biomedical Corporation 41293D 06.2018 NOVA Lact Plus Meter PN 41293D.indd 60 6/12/18 8:50 AM...

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