NOVA BIOMEDICAL Nova StatSensor Xpress-i Instructions For Use Manual
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NOVA BIOMEDICAL Nova StatSensor Xpress-i Instructions For Use Manual

Creatinine hospital meter
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Creatinine Hospital Meter
Instructions for Use Manual
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Summary of Contents for NOVA BIOMEDICAL Nova StatSensor Xpress-i

  • Page 1 Nova StatSensor Xpress-i ® ™ Creatinine 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................6 Introduction..................9 Clinical.Utility................13 The.Sample................13 Interfering.Substances............14 Operation.Overview...............15 Meter.Sleep/Wakeup..............16 Setup..................18 Installing.the.Battery.(Replacing)...........19 Set.the.Time................21 Set.Date.Format..............24 Beeper.On.or.Off..............28 Set.Offset:.Blood.Creatinine.Result.Only.......29 Testing:.QC/Linearity/Proficiency/Blood.Samples.....32 When.to.Perform.a.QC.Test...........32 StatSensor.Creatinine.Control.Solution.........33...
  • Page 4 Table of Contents Testing.a.Quality.Control.Solution..........34 Testing.a.Blood.Sample............38 Testing.a.Linearity/Proficiency.Solution.........43 Reviewing.Test.Results............46 Deleting.Stored.Test.Results..........47 Troubleshooting.................49 Battery.Check................49 Error.Codes................53 Appendix...................57 A.1.Specifications..............58 A.2.Reference.Values............59 A.3.Creatinine.Methodology...........60 A.4.Quality.Control.Solution...........61 A.5.Chemistry.Measurement..........61 A.6.Ordering.Information............62 A.7.Cleaning.and.Care............63 Warranty..................65...

  • 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 Discard 90 days after opening Product fulfills the requirements of Directive 98/79 EC (IVDD) Temperature limitation Caution, consult accompanying...

  • Page 6: About.this.manual

    Creatinine Meter. ™ Unit of Measure Information The unit of measure of the Nova StatSensor Xpress-i Creatinine Meter is factory set to the standards in the country of use. The Meter either reports creatinine results in mg/dL or µmol/L and can not be changed. Separate Result screens and specifications are shown in the Instructions for Use Manual for each unit of measure.

  • Page 7: Safety

    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 8 Electrical Safety 1. Battery powered: 3-volt coin battery 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 9 Safety applicable collection point for the recycling of electri- cal and electronic equipment. 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 •...

  • Page 10: Intended.use

    Weight: 75 g (2.65 oz) Intended Use The Nova StatSensor Xpress-i Creatinine Meter System is intended for in vitro diagnostic use by health care pro- fessionals and for point-of-care usage in the quantitative determination of Creatinine (Creat ) in capillary, venous, and arterial whole blood.
  • Page 11 Creatinine Test Strip Strip Ejector Button mg/dL µmol/L Left Arrow Button Right Arrow Button Mode Button Result in mg/dL Result in µmol/L Nova StatSensor Xpress-i Creatinine Meter...
  • Page 12 Creatinine Beeper ON Indicator Creatinine Test Blood or Control Result Drop Indicator Test Result mg/dL or µmol/L Low Battery Indicator Memory AM or PM Indicator Date/Day Hour/Minute Nova StatSensor Xpress-i Creatinine Meter Screen...

  • Page 13: Introduction

    Introduction WARNING: 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 ca- pable of transmitting viral diseases, even after cleaning. This section introduces the meter and covers requirements, tests performed, procedural limitations, clinical utility, and sample handling.
  • Page 14 • Discard used test strips according to local regulations. • Use only the Nova StatSensor-i Creatinine Test Strips for testing with the Nova StatSensor Xpress-i Creati- nine Meter. • If test result is higher or lower than expected, run a control solution test.
  • Page 15 Introduction Additional Information for Healthcare Professionals • The Nova StatSensor-i Creatinine Test Strips are calibrated against plasma. • The Nova StatSensor-i Creatinine Test Strips are used for whole blood testing only.
  • Page 16 Introduction The Nova StatSensor Xpress-i Creatinine Meter is a hand-held, battery-powered, in vitro diagnostic laboratory instrument that works in conjunction with Nova Biomedical creatinine electrochemical test strips to measure creatinine in a whole blood sample, a Quality Control (QC) solution, linearity, or proficiency solutions. The meter can store up to 400 patient and/or quality control test results.

  • Page 17: Clinical.utility

    Clinical Utility The StatSensor Xpress-iCreatinine Meter is intended for in vitro diagnostic use by health care professionals and for Point-Of-Care usage for the quantitative measurement of creatinine in capillary, venous, and arterial whole blood. Creatinine measurements are used in the diagnosis and treatment of renal diseases and in monitoring renal dialysis.

  • Page 18: Interfering.substances

    Introduction Interfering Substances Creatinine Interferences: The Nova StatSensor Xpress-i Creatinine 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) D(+) Maltose Mono 100.0 Acetaminophen 10.0 (0.66) Oxygen All Conc Ascorbic Acid (0.20)

  • 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 30 seconds. •...

  • Page 20: Meter.sleep/Wakeup

    • 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. An auto sleep feature conserves power when the meter is not in use.
  • Page 21 Introduction 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. • If the currently displayed screen is a Setup screen, any unconfirmed input data or menu selection are discarded prior to blanking.

  • Page 22: Setup

    Setup This section describes how to setup the Nova StatSensor Xpress-i Creatinine 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.

  • Page 23: Installing.the.battery.(Replacing)

    Setup Installing the Battery (Replacing) The meter is powered by a single 3V coin cell battery, 2450. Install/Replace the battery as follows: 1. Remove the back battery cover on the meter. 2. Install the coin cell battery with the + side facing up. (If replacing the battery, remove the used battery and replace with a new one.)
  • Page 24 Setup 3. Replace the battery cover. All segments flash 3 times. The software version and the default date and time will appear for 3 seconds then the screen will go blank. CAUTION: Upon installing the battery, the meter software version is displayed for 3 seconds. Software versions are alpha characters.

  • Page 25: Set.the.time

    Setup 4. Go to setup to configure the meter. Set the Time 1. Press the MODE button for longer than 3 seconds. The meter if in Sleep Mode wakes up and enters the SETUP Mode.
  • Page 26 Setup 2. Select the hour (flashing) format: either 12 Hr or 24 Hr. Press the Right/Left Arrow buttons to toggle between the 2 time format options. 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.
  • Page 27 Setup 8. Press the MODE button to accept the displayed Min- utes choice.

  • Page 28: Set.date.format

    Setup Set Date Format 1. Next set the date format. The display is 1-31 2010 or 31.01.2010. 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 29 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 30 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 31 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 32: Beeper.on.or.off

    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 33: Set.offset:.blood.creatinine.result.only

    Setup Set Offset: Blood Creatinine Result Only 1. For mg/dL meters, press the Right/Left Arrow buttons to set the offset from -0.95 to 0.95 mg/dL in increments of 0.05 mg/dL. For µmol/L meters, press the Right/Left Arrow buttons to set the offset from -95 to 95 µmol/L in increments of 5 µmol/L.
  • Page 34 Setup Minimum to Maximum Minimum to Maximum Offset Screens for mg/dL Offset Screens for µmol/L Meters Meters 2. Press the MODE button to accept the displayed Offset for Creatinine Blood Result Only.
  • Page 35 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 36: Testing:.qc/Linearity/Proficiency/Blood.samples

    External control materials are available from Nova Biomedical for verifying the integrity of the Nova StatSensor Xpress-i Creatinine Meter. These StatSensor Creatinine Control Solutions consist of 3 levels of ready-to-use liquid controls.

  • Page 37: Statsensor.creatinine.control.solution

    Only the Nova StatSensor Creatinine Control Solutions are recommended for use with the Nova StatSensor Xpress-i Creatinine Meter and the Nova StatSensor Creatinine Test Strips. Ranges for the Nova StatSensor Xpress-i Creatinine Meter using other commercially available creatinine controls have not been established and may give erroneous results.

  • Page 38: Testing.a.quality.control.solution

    Testing a Quality Control Solution • Each new operator • Before using the StatSensor Meter for the first time • When opening a new vial of test strips • If a patient test has been repeated and the blood creatinine results are still lower or higher than expected •...
  • Page 39 Testing a Quality Control Solution Good Laboratory Practice principles suggest that external controls must be run whenever the laboratory director has any question about the test system integrity or operator technique. This section describes how to run QC (Quality Control), Linearity Solution, Proficiency Solution, and blood samples.
  • Page 40 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, C2, or C3. 3. Touch the end of the test strip to a drop of control solution until the test strip fills and the meter beeps.
  • Page 41 Testing a Quality Control Solution 4. Creatinine quality control test results are available on-screen in 30 seconds. Result Result Displayed Displayed in mg/dL in µmol/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 42: 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 43 Testing a Blood Sample 2. Wash patient's hand with water then dry thoroughly. Alternatively, use alcohol pads to clean area; dry thoroughly after cleaning. 3. Holding hand down- ward, massage finger with thumb toward tip to stimulate blood flow. 4. Use a lancet to puncture the finger.
  • Page 44 Testing a Blood Sample 5. Squeeze the finger to form a drop of blood. 6. When the blood drop appears, touch the end of the test strip to the blood drop until the test strip fills and the meter beeps. 7.
  • Page 45 Testing a Blood Sample Result in mg/dL Result in µmol/L 8. 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 46 Testing a Blood Sample If result is LO (less than the measurement range) or Hi (greater than the measurement range) repeat the test. HI in mg/dL LO in µmol/L (>12.0mg/dL) (<27µmol/L) NOTE: Test results are automatically saved. If no activity for 1 minute, the meter will time-out: screen goes blank.

  • Page 47: Testing.a.linearity/Proficiency.solution

    Testing a Linearity/Proficiency Solution This section describes how to perform Linearity tests with the StatSensor Xpress-i Creatinine Meter. There are 5 levels in the StatSensor Creatinine Linearity kit. Refer to the StatSensor Creatinine Linearity Kit package insert sheet for complete instructions, indi- cations, precautions, and limitations of the system.
  • Page 48 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 30 seconds.
  • Page 49 Testing a Linearity/Proficiency Solution Result in mg/dL Result in µmol/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 50: Reviewing.test.results

    Reviewing Stored 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 51 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. 3.

  • Page 52: Deleting.stored.test.results

    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 53: Troubleshooting

    Troubleshooting This section describes Battery status, Error Codes, and Ac- tions for the Nova StatSensor Xpress-i Creatinine 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 54 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 55 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 56 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. CAUTION: Attempts to perform Battery Icon creatinine testing with a low battery could result in the software rebooting.

  • Page 57: 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 58 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.
  • Page 59 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 60 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. E9 Bad Sample Error A problem was detected with the sample.

  • Page 61: 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 information, and warranty.

  • Page 62: A.1.Specifications

    Appendix A.1 Specifications Tests Measured Blood Creatinine Creatinine Methodology Enzyme, Amperometric Creatinine Test Results mg/dL, µmol/L Sample Type Whole Blood: Capillary, Arterial, and Venous Creatinine Test Range 0.30 to 12.0 mg/dL 27 to 1056 µmol/L Test Time 30 seconds Test Strip Volumes 1.2 µL Memory storage 400 Tests...

  • Page 63: A.2.Reference.values

    Appendix Operating Ranges: Temperature 59° to 104°F (15° to 40°C) Humidity 10% to 90% relative humidity Altitude 15,000 ft (4572 meters) Hematocrit 20% to 65% Weight 2.65 oz (75 g) Size 3.6x2.3x0.9 in(91.4x58.4x22.9 mm) A.2 Reference Values Each laboratory should establish and maintain its own reference value.

  • Page 64: A.3.Creatinine.methodology

    Appendix A.3 Creatinine Methodology The creatinine measurement is based on the following methodology: Enzymes 1. Creatinine + O ––––––––– > H Enzymes 2. H + Ferrocyanide ––––––––– > Ferricyanide + H 3. Ferricyanide ––––––––– > Ferrocyanide Electrode The current generated at the electrode is proportional to the creatinine concentration of the sample.

  • Page 65: A.4.Quality.control.solution

    Appendix A.4 Quality Control Solution QC Solutions Levels 1, 2, 3 Linearity Solutions Levels 1, 2, 3, 4, 5 A.5 Chemistry Measurement The typical imprecision for creatinine both for within-run and day-to-day Creatinine Levels Creatinine Levels (mg/dL) (µmol/L)

  • Page 66: A.6.Ordering.information

    Appendix A.6 Ordering Information Supplies and parts for the Nova StatSensor Xpress-i Creatinine Meter are available from Nova Biomedical. DESCRIPTION ............Instructions for Use Manual ........49011 Quick Reference Guide .......... 49018 StatSensor-i Creatinine Test Strips ......43272 Creatinine Control Solution, Level 1 ...... 43921 Creatinine Control Solution, Level 2 ......

  • Page 67: A.7.Cleaning.and.care

    A.7 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 68 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! 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.

  • Page 69: 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 70 1. The date printed on the package label has been exceeded. 2. Non-Nova Biomedical reagents or controls are used, as follows: Nova Biomedical will not be responsible for any warranty on Nova StatSensor Xpress-i Creati- nine 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 71 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 73 Authorized Representative Nova Biomedical Corporation Telephone: + 44 1928 704040 Innovation House Fax: + 44 1928 706792 Aston Lane South, Runcorn Cheshire, WA7 3FY, UK For technical assistance outside the United States, call your local Nova subsidiary or authorized distributor.
  • Page 74 Fax: 1-781-893-6998 U.S.A. Web: www.novabiomedical.com U.S. Patent Nos. 6,258,229; 6,837,976; and 6,942,770 CA 2,375,089; 2,375,092 Made in the USA by Nova Biomedical Corporation StatSensor Xpress-i™ is a trademark of Nova Biomedical Corporation. ® Copyright 2011 Nova Biomedical Corporation 49011C 2011-10...

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