NOVA BIOMEDICAL StatStrip Xpress Instructions For Use Manual
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NOVA BIOMEDICAL StatStrip Xpress Instructions For Use Manual

Lactate hospital meter
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Lactate Hospital Meter
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  • Page 1 Nova StatStrip Xpress Lactate Hospital Meter Instructions for Use Manual For Export Only...

  • Page 3: Table Of Contents

    Table of Contents Symbols..................1 About.This.Manual...............2 Safety..................3 Intended.Use................8 Introduction..................9 Clinical.Utility................13 The.Sample................13 Interfering.Substances............14 Operation.Overview...............15 Meter.Sleep/Wakeup..............17 Setup..................18 Installing.the.Battery.(Replacing)...........18 Set.the.Time................20 Set.Date.Format..............23 Beeper.On.or.Off..............27 Testing:.QC/Linearity/Proficiency/Blood.Samples.....29 Testing.a.Quality.Control.Solution..........29 Testing.a.Blood.Sample............34...
  • Page 4 Table of Contents Testing.a.Linearity/Proficiency.Solution.........38 Reviewing.Test.Results............41 Deleting.Stored.Test.Results..........42 Troubleshooting.................44 Battery.Check................44 Error.Codes................48 Appendix...................52 Specifications.................53 Reference.Values..............54 Lactate.Methodology..............55 Quality.Control.Solution............56 Chemistry.Measurement............56 Ordering.Information..............57 Cleaning.and.Care..............58 Warranty..................60...

  • Page 5: Symbols

    Symbols The following are symbols that are used in this manual, on insert sheets, and on the meter. In vitro diagnostic medical Electronic Waste device Authorized Representative Catalog number in the European Community Product fulfills the requirements Temperature limitation of Directive 98/79 EC (IVDD) Caution, consult accompanying documents Upper Limit of Temperature...

  • Page 6: About.this.manual

    About This Manual This manual is for the Nova Biomedical StatStrip Xpress Lactate Meter. Unit of Measure Information The unit of measure of the StatStrip Xpress Lactate Hospital Meter is factory set to mmol/L. Throughout this manual: NOTES provide important or helpful operating information. CAUTIONS provide information that is important for instru- ment protection.

  • Page 7: Safety

    3. Observe all warnings on the meter and in the operating instructions. 4. Follow all operating and use instructions. 5. The meter should be cleaned only as recommended by the Nova Biomedical. Electrical Safety 1. Battery powered: 3-volt coin battery...
  • Page 8 Safety 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. Disposal of Used Batteries for customers in Europe. •...
  • Page 9 Safety Disposal of Used Meters for customers in Europe. • The meter may become infectious during the course of use. Discard in accordance with local regulations for biohazardous waste. Environmental • Operating temperature range: 59˚F to 104˚F (15˚C to 40˚C) •...
  • Page 10 Lactate Test Strip LCD Display Test Strip Ejector mmol/L Push Up to Eject Right Arrow Button Left Arrow Button Mode Button Result in mmol/L Nova StatStrip Xpress Lactate Hospital Meter...
  • Page 11 Lactate Beeper ON Indicator Lactate Test Blood or Control Result Drop Indicator Test Result mmol/L Low Battery Indicator Memory AM or PM Indicator Date/Day Hour/Minute Nova StatStrip Xpress Lactate Hospital Meter Screen...

  • Page 12: Intended.use

    Intended Use The Nova StatStrip Xpress Lactate Meter System is intend- ed for in vitro diagnostic use by health care professionals and for point-of-care usage in the quantitative determination of Lactate (Lac) in fresh venous and arterial whole blood. It is intended to provide plasma equivalent results to labora- tory methods.

  • Page 13: Introduction

    Introduction This manual provides all necessary instructions for the routine operation and maintenance of the Nova StatStrip Xpress Lactate Meter. Please read this manual carefully. It has been prepared to help you attain optimum performance from your Meter. WARNING: Blood samples and blood products are potential sources of infectious agents.
  • Page 14 Introduction • Prior to use, read the StatStrip Lactate Meter In- structions for Use Manual. • DO NOT reuse test strips. • Discard used test strips according to local regulations. • Use only the Nova StatStrip Lactate Test Strips with the Nova StatStrip Lactate Meter.
  • Page 15 Introduction Additional Information for Healthcare Professionals • The Nova StatStrip Lactate Test Strips are calibrated against plasma. • The Nova StatStrip Lactate Test Strips are used for whole blood testing only. • Healthcare professionals and others using this system on multiple patients should be aware that all products or objects that come into contact with human blood should be handled as if capable of transmitting viral diseases, even after cleaning.
  • Page 16 Introduction The Nova StatStrip Xpress Lactate Meter is a hand-held, battery-powered, in vitro diagnostic laboratory instrument that works in conjunction with Nova Biomedical lactate electrochemical test strips to measure lactate in a whole blood sample, a Quality Control (QC) solution, linearity, or proficiency solutions.

  • Page 17: Clinical.utility

    Introduction Clinical Utility The Measurements of lactic acid (lactate) in whole blood, serum, and plasma are used to evaluate the acid-base status of patients suspected of having lactic acidosis. Ref. 1. Burtis, Carl A. and Ashwood, Edward R., ed. 1999. Tietz Textbook of Clinical Chemistry. Philadel- phia, PA: W.

  • Page 18: Interfering.substances

    Introduction Interfering Substances Lactate Interferences: The Nova StatStrip Xpress Lactate Hospital Meter exhibits no interference from the following substances up to the following concentration levels: Substances Conc Substances Conc mg/dL(mmol/L) mg/dL(mmol/L) L-Dopa (0,25) Acetaminophen 20.0 (0.66) Methyl-Dopa (0.042) Ascorbic Acid 10.0...

  • Page 19: Operation.overview

    Introduction Operation Overview • To perform a test, the operator inserts a test strip into the test strip port. Touch the end of the strip to a drop of blood, QC solution, or linearity solution. The results are obtained in 13 seconds. •...
  • Page 20 Introduction • A coin-size battery provides power to operate the meter. The battery provides sufficient power to operate for approximately 600 tests. A low-battery warning on the meter display alerts the operator to change the battery.

  • Page 21: Meter.sleep/Wakeup

    Introduction Meter Sleep/Wakeup The LCD display is turned off to conserve battery power (sleep mode) after one minute of no activity. If the meter goes into sleep mode, the following conditions should be expected: • If blanking occurs when a Patient Result screen is displaying, the result is automatically saved.

  • Page 22: Setup

    Setup This section describes how to setup the Nova StatStrip Xpress Lactate 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 a single 3V coin cell battery, 2450.
  • Page 23 Setup 3. Replace the battery cover. All segments flash 3 times. The software version and the current date and time will appear for 3 seconds then the screen will go blank. 4. If this is the initial installation, go to setup. If this is a battery replacement and the battery was replaced successfully within the time limit (30...

  • Page 24: Set.the.time

    Setup seconds), all setup settings will be saved. If this is a battery replacement and the battery was not replaced within the time limit (30 seconds), the time and date settings may be lost. The software version and the default date and time will appear for 3 seconds.
  • Page 25 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. 5. Press the Right/Left Arrow buttons to scroll from 1AM to 12PM (for 12 Hr Clock) or 0 to 23 (for 24 Hr Clock).
  • Page 26 Setup 6. Press the MODE button to accept the displayed Hour choice. 7. Next set the minutes (digits flashing). Press the Right/Left Arrow buttons to scroll from 00 to 59 minutes. 8. Press the MODE button to accept the displayed Min- utes choice.

  • Page 27: Set.date.format

    Setup Set Date Format 1. Next set the date format. The display is 12-31 2010 or 31.12.2010. 2. You can choose to have the date displayed as DD.MM or MM-DD. Press the Right/Left Arrow buttons to toggle between DD.MM or MM-DD. 3.
  • Page 28 Setup 4. The year should be flashing. Press the Right/Left Arrow buttons to select the current year. 5. Press the MODE button to accept the displayed Year.
  • Page 29 Setup 6. The month should be flashing. Press the Right/ Left Arrow buttons to scroll through the 12 months (1 to 12). 7. Press the MODE button to accept the displayed Month.
  • Page 30 Setup 8. The day should be flashing. Press the Right/Left Ar- buttons to scroll through the days of the month. 9. Press the MODE button to scroll the displayed Day.

  • Page 31: Beeper.on.or.off

    Setup Beeper On or Off 1. Press the Right/Left Arrow buttons to toggle between Beeper ON or OFF (flashing). 2. Press the MODE button to accept the displayed ON or OFF.
  • Page 32 Setup End is displayed 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 33: Testing:.qc/Linearity/Proficiency/Blood.samples

    Testing a Quality Control Solution Only the Nova StatStrip Lactate Control Solutions are rec- ommended for use with the Nova StatStrip Xpress Lactate Meter and the Nova StatStrip Lactate Test Strips. Run 2 different levels of the StatStrip Lactate Control Solutions...
  • Page 34 Testing a Quality Control Solution • As required by the institution’s quality control policy or local regulatory requirements • Anytime there is a concern the accuracy of the meter may have been affected by rough handling (such as dropping the meter).
  • Page 35 Testing a Quality Control Solution The following section explains how to run a Quality Control Test with one of the 2 StatStrip Lactate Control Solutions. Read the StatStrip Lactate Solution package insert sheet for complete instructions, indications, precau- tions, and limitations of the system. 1. Insert a test strip into the meter. All segments of the screen will display for 2 seconds.
  • Page 36 Testing a Quality Control Solution 2. Identify the sample as a Control; use the Left or Right button to find the desired control level: C1 and 3. Touch the end of the test strip to a drop of control solution until the test strip fills and the meter beeps. NOTE: A quick beep sounds when sufficient control solution has been added to the test strip.
  • Page 37 Testing a Quality Control Solution 4. Lactate quality control test results are available on- screen in 13 seconds. Result Displayed in mmol/L 5. There is one long beep when the results are ready. There are 3 short beeps if test results are outside the measurement range of the test strip.

  • Page 38: Testing.a.blood.sample

    Testing a Blood Sample NOTE: Do not test patient samples until control solution test results are within expected range. 1. Insert a test strip into the meter. All segments of screen will display for 2 seconds. Then a flashing blood drop will display. NOTE: If strip is re- moved before the test starts or is not used for over 2 minutes, the screen will go blank.
  • Page 39 Testing a Blood Sample 2. Draw a fresh blood sample from an artery or a vein. 3. Perform a Lactate test immediately after drawing the whole blood sample. 4. Use either a syringe or a pipette to add a blood drop to the Lactate test strip.
  • Page 40 Testing a Blood Sample Result in mmol/L 7. There is one long beep when the results are ready. There are 3 short beeps if test results are outside the range of the test strip.
  • Page 41 Testing a Blood Sample If result is LO (less than the measurement range) or Hi (greater than the measurement range) repeat the test. HI Lactate LO Lactate (>20 mmol/L Lac) (<0.3 mmol/L Lac) NOTE: Test results are automatically saved. If no activity for 1 minute, the meter will time-out: screen goes blank.

  • Page 42: Testing.a.linearity/Proficiency.solution

    Testing a Linearity/Proficiency Solution This section describes how to perform Linearity tests with the StatStrip Xpress Lactate Hospital Meter. There are 4 levels in the StatStrip Lactate Linearity kit. 1. Insert a test strip into the meter. All segments of screen will display for 2 seconds.
  • Page 43 Testing a Linearity/Proficiency Solution 2. Touch the end of the test strip to a drop of linearity solution or proficiency solution until the test strip fills and the meter beeps. NOTE: LinearitylProficiency test results are stored in memory as a blood sample. NOTE: A quick beep sounds when sufficient linearity/ proficiency solution has been added to the test strip. 3. Linearity or proficiency test results are available on- screen in 13 seconds.
  • Page 44 Testing a Linearity/Proficiency Solution Result in mmol/L 4. There is one long beep when the results are ready. There are 3 short beeps if test results are outside the measurement range of the test strip.

  • Page 45: Reviewing.test.results

    Reviewing Test Results The meter is able to store up to 400 test results. 1. To review test results, press the Mode button once for less than 3 seconds. 2. If there are no results in memory, the screen displays - - - on the mem (memory) screen.

  • Page 46: Deleting.stored.test.results

    Deleting Stored Test Results You can delete all stored test and QC results. Proceed as follows to delete all results: 1. Press the Mode button once to display the number of stored test results. 2. Press the Right and Left arrow button simultaneously for longer than 3 seconds.
  • Page 47 Deleting Stored Test Results 4. When the Screen displays dELEtE (flashing), press the left and right buttons simultaneously for greater than 3 seconds. All results are deleted. The screen will display OK and dELEtEd as shown below. 5. To exit without deleting results. press the MODE button once.

  • Page 48: Troubleshooting

    Troubleshooting This section describes Battery status, Error Codes, and Ac- tions for the Nova StatStrip Xpress Lactate Hospital Meter. Battery Check The battery provides sufficient power to operate for approximately 600 tests. A battery low warning will alert the user to replace the battery. Test results are stored in non-...
  • Page 49 Troubleshooting How to view the battery status of the meter: • Insert a test strip to the meter when it is turned off. • All segments will display for 2 seconds. • Battery is OK: a flashing blood drop appears at the lower left corner of the screen.
  • Page 50 Troubleshooting • Battery is Low: a flashing blood drop and battery icon appear at the lower left corner of the screen: battery charge sufficient for up to 10 tests. Continue with testing as usual. Battery icon remains on the screen. Battery Icon Flashing Blood Drop...
  • Page 51 Troubleshooting • Battery is very Low: battery icon at the lower left corner of the screen: battery charge insufficient for testing. Meter will not operate and battery icon disappears when the test strip is removed. Replace the battery. Battery Icon...

  • Page 52: Error.codes

    Troubleshooting Error Codes There are 8 Error Codes to inform you of problems with the meter. This section provides action procedures when these Error Codes are displayed. The error code displays after the test strip is inserted and the all segments screen displays for 2 seconds.
  • Page 53 Troubleshooting E1 System Hardware Error A system hardware error has been detected. Action: Perform the test again. If you get the same error, call Nova Technical Support. E2 Operating Temperature Error The Meter temperature is outside of the range for testing. Action: Move the meter to an area where the temperature is acceptable (59°-104°F or 15°-40°C), allow meter to adjust to the...
  • Page 54 Troubleshooting E3 Used Strip Error The test strip was previously used. Action: Repeat the test with a new test strip. If the error persists, perform the test using an alternate test strip vial or alternate method. E4 Short Sample Error An insufficient sample volume (Control or blood) was drawn into the test strip.
  • Page 55 Troubleshooting E5 Strip Not Recognized Error The test strip is not recognized. Action: Repeat the test with a new test strip. If the error persists, perform the test using an alternate test strip vial or alternate method. E8 Bad Strip Error The test strip is defective or bad.

  • Page 56: Appendix

    Troubleshooting E9 Bad Sample Error A problem was detected with the sample. Action: Repeat the test with a new test strip. If the error persists, perform the test using an alternate test strip vial or alternate method. Appendix The Appendix includes solution and reagent specifications, accuracy and precision, consumable list, reference informa- tion, and warranty.

  • Page 57: Specifications

    Appendix Specifications Tests Measured Blood Lactate (referred to Plasma Values) Lactate Methodology Enzyme, Amperometric Lactate Test Results mmol/L Sample Type Whole blood: Venous & Arterial Lactate Test Range 0.3 to 20.0 mmol/L Test Time 13 seconds Test Strip Volumes 0.6 µL Memory storage 400 Tests Battery Life (nominal)

  • Page 58: Reference.values

    Appendix Operating Ranges: Temperature 59° to 104°F (15° to 40°C) Humidity 10% to 90% relative humidity Hematocrit 20% to 65% Weight 2.65 oz (75 g) Size 3.6x2.3x0.9 in(91.4x58.4x22.9 mm) Reference Values Each laboratory should establish and maintain its own reference value.

  • Page 59: Lactate.methodology

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

  • Page 60: Quality.control.solution

    Appendix Quality Control Solution QC Solutions Levels 1, 2 Linearity Solutions Levels 1, 2, 3, 4 Chemistry Measurement The typical imprecision for lactate both for within-run and day-to-day Lactate Levels (mmol/L) 0.76 2.16 10.5 16.8...

  • Page 61: Ordering.information

    Appendix Ordering Information Supplies and parts for the Nova StatStrip Xpress Lactate Hospital Meter are available from Nova Biomedical. DESCRIPTION ............Instructions for Use Manual ........47654 Quick Reference Guide .......... 47631 StatStrip Lactate Test Strips, 50 test strips per box 47486 Lactate Control Solution, Level 1 ......

  • Page 62: Cleaning.and.care

    Appendix Cleaning and Care The meters should never be immersed in any cleaning agent. Always apply the cleaning agent to a soft cloth to wipe the meter surface. Once complete, immediately dry thoroughly. When cleaning the meter, please follow the guidelines listed below: •...
  • Page 63 Appendix CAUTION: DO NOT immerse the meter or hold the meter under running water. DO NOT spray the meter with a disinfectant solution. CAUTION: Do Not attempt to open the meter to make any repairs. Your warranty and all claims will be void! Call Nova Biomedical or an authorized dealer if the meter needs to be repaired or checked.

  • Page 64: Warranty

    Warranty Subject to the exclusions and upon the conditions specified below, Nova Biomedical 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 after delivery to the customer because of defective material or workmanship.
  • Page 65 1. The date printed on the package label has been exceeded. 2. Non-Nova Biomedical reagents or controls are used, as follows: Nova Bio- medical will not be responsible for any warranty on Nova StatStrip Xpress Lactate Hospital Meter if used in conjunction with and are adversely affected by reagents, controls, or other material not manufactured by Nova but which contact or affect such parts.
  • Page 66 DAMAGES IN CONNECTION WITH THE SALE OR FURNISHING OF GOODS OR PARTS, THEIR DESIGN, SUITABILITY FOR USE, INSTAL- LATION OR OPERATION. NOVA BIOMEDICAL WILL IN NO EVENT BE LIABLE FOR ANY SPECIAL OR CONSEQUENTIAL DAMAGES WHAT- SOEVER, AND OUR LIABILITY UNDER NO CIRCUMSTANCES WILL EXCEED THE CONTRACT PRICE FOR THE GOODS FOR WHICH THE LIABILITY IS CLAIMED.
  • Page 67 Deeside Industrial Park, Deeside Flintshire, CH5 2JZ For technical assistance outside the United States, call your local Nova subsidiary or authorized distributor. Nova Biomedical Canada Ltd. Nova Biomedical UK Nova Biomedical GesmbH 17 - 2900 Argentia Road C3-5 Evans Business Centre...
  • Page 68 200 Prospect Street 1-781-894-0800 Waltham, MA 02454-9141 Fax: 1-781-893-6998 U.S.A. Web: www.novabiomedical.com U.S. Patent Nos. 6,258,229; 6,287,451; 6,837,976; and 6,942,770 CA 2,375,089; 2,375,092; EP 1,212,609 Made in the USA by Nova Biomedical Corporation Copyright 2011 Nova Biomedical Corporation 47654B 03.2011...

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