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

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NOVA BIOMEDICAL Nova StatSensor Xpress-i Instructions For Use Manual Download Page 65

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 

CV%

 

(mg/dL) 

(µmol/L) 

 

1 

88 

8%

 

5 

440 

6%

 

10 

880 

4%

 

 

 

 

Appendix

Summary of Contents for Nova StatSensor Xpress-i

Page 1: ...Nova StatSensor Xpress i Creatinine Hospital Meter Instructions for Use Manual For Export Only...

Page 2: ......

Page 3: ...ering 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 O...

Page 4: ...esults 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...

Page 5: ...REP EC Authorized Representative in the European Community Product fulfills the requirements of Directive 98 79 EC IVDD Caution consultaccompanying documents Consult instructions for use Biological ri...

Page 6: ...Meter either reports creatinine results in mg dL or mol L and can not be changed Separate Result screens and specifications are shown in the Instructions for Use Manual for each unit of measure Throug...

Page 7: ...1 Read the safety and operating instructions before operating the meter 2 Retain the safety and operating instructions for future reference 3 Observe all warnings on the meter and in the operating ins...

Page 8: ...appropriate environment 3 Dispose of all waste solutions according to standard hospital procedures Disposal of Used Batteries for customers in Europe This symbol on the battery label indicates that t...

Page 9: ...come infectious during the course of use Discard in accordance with local regulations for biohazardous waste Environmental The operating temperature range for Meter operation 59 F to 104 F 15 C to 40...

Page 10: ...tem 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: ...7 Nova StatSensor Xpress i Creatinine Meter Left Arrow Button Mode Button Right Arrow Button Creatinine Test Strip mg dL mol L Result in mg dL Result in mol L Strip Ejector Button...

Page 12: ...Battery Indicator Blood or Control Drop Indicator Test Result mg dL or mol L Beeper ON Indicator Creatinine Test Result AM or PM Indicator Date Day Hour Minute Nova StatSensor Xpress i Creatinine Met...

Page 13: ...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 an...

Page 14: ...ng with the Nova StatSensor Xpress i Creati nine Meter If test result is higher or lower than expected run a control solution test Remove the test strip from the vial only when ready to test Do not us...

Page 15: ...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: ...al 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: ...ive 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 Not for us...

Page 18: ...vels Substances Conc mg dL mmol L Acetaminophen 10 0 0 66 Ascorbic Acid 3 5 0 20 Bilirubin 15 0 0 26 Cholesterol 1000 0 25 8 Creatine 4 0 0 35 Dopamine 10 0 0 53 Glucose 500 0 27 8 Hematocrit RBC 30 6...

Page 19: ...onds Prior to analysis the operator may designate the test sample as a quality control sample level C1 C2 or C3 Test results are automatically stored into non volatile memory The operator can recall a...

Page 20: ...ow 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 Meter Sleep Wakeup The LCD display is turned off to...

Page 21: ...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 blankin...

Page 22: ...ection 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...

Page 23: ...y 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 batter...

Page 24: ...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...

Page 25: ...21 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 Setup...

Page 26: ...our 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...

Page 27: ...23 8 Press the MODE button to accept the displayed Min utes choice Setup...

Page 28: ...ormat 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 Press the MODE button t...

Page 29: ...25 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 Setup...

Page 30: ...26 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 Setup...

Page 31: ...27 8 The day should be flashing Press the Right Left Ar row buttons to scroll through the days of the month 9 Press the MODE button to scroll the displayed Day Setup...

Page 32: ...28 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: ...from 0 95 to 0 95 mg dL in increments of 0 05 mg dL For mol L meters press the Right Left Arrow buttons to set the offset from 95 to 95 mol L in increments of 5 mol L NOTE The Meter stores the offset...

Page 34: ...30 2 Press the MODE button to accept the displayed Offset for Creatinine Blood Result Only Setup Minimum to Maximum Offset Screens for mol L Meters Minimum to Maximum Offset Screens for mg dL Meters...

Page 35: ...31 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 Setup...

Page 36: ...ors due to system failures and operator performance External control materials are available from Nova Biomedical for verifying the integrity of the Nova StatSensor Xpress i Creatinine Meter These Sta...

Page 37: ...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 cont...

Page 38: ...er cleaning the test strip port on the meter If there are other indications that the system is not working properly Whenever problems storage operator instrument are identified or anytime there is a c...

Page 39: ...This section describes how to run QC Quality Control Linearity Solution Proficiency Solution and blood samples 1 Insert a test strip into the meter All segments of the screen will display for 2 secon...

Page 40: ...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 NOTE A quick beep sounds when sufficient control so...

Page 41: ...e on screen in 30 seconds 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 Result Displayed in mg dL Test...

Page 42: ...thin 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 i...

Page 43: ...n 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 punc...

Page 44: ...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 Creatinine test results are available on screen in 30...

Page 45: ...41 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 Testing a Blood Sample Result in mg dL Result in mol L...

Page 46: ...t range or Hi greater than the measurement range repeat the test NOTE Test results are automatically saved If no activity for 1 minute the meter will time out screen goes blank HI in mg dL 12 0mg dL L...

Page 47: ...ine Linearity Kit package insert sheet for complete instructions indi cations precautions and limitations of the system 1 Insert a test strip into the meter All segments of screen will display for 2 s...

Page 48: ...ncy 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 proficienc...

Page 49: ...a Linearity Proficiency Solution 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 Result in mg dL Result...

Page 50: ...y the screen displays on the mem memory screen If there are tests saved the most recent test is displayed first 3 Press the left arrow button to scroll backward thru results Press the right arrow butt...

Page 51: ...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 The screen displays the number of samples in...

Page 52: ...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 M...

Page 53: ...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 t...

Page 54: ...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 Continue with testing...

Page 55: ...ood 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 Flashing Blood Dr...

Page 56: ...rate and battery icon disappears when the test strip is removed Replace the battery Battery Icon Troubleshooting CAUTION Attempts to perform creatinine testing with a low battery could result in the s...

Page 57: ...isplays after the test strip is inserted and the all segments screen displays for 2 seconds If the beeper is enabled there are also 3 quick beeps Then the Error Code is displayed on the screen E0 Soft...

Page 58: ...e 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 t...

Page 59: ...ersists 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 Action Repeat the tes...

Page 60: ...p 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 Action Repeat the test with a new test strip...

Page 61: ...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 an...

Page 62: ...Creatinine Test Results mg dL mol L Sample Type Whole Blood Capillary Arterial and Venous Creatinine Test Range 0 30 to 12 0 mg dL 27 to 1056 mol L Test Time 30 seconds Test Strip Volumes 1 2 L Memory...

Page 63: ...1 4x58 4x22 9 mm A 2 Reference Values Each laboratory should establish and maintain its own reference value The value given here should be used only as a guide Creatinine male 1 0 7 1 3 mg dL 61 9 114...

Page 64: ...ment is based on the following methodology Enzymes 1 Creatinine O2 H2 O2 Enzymes 2 H2 O2 Ferrocyanide Ferricyanide H2 O e 3 Ferricyanide Ferrocyanide Electrode The current generated at the electrode i...

Page 65: ...tions 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 CV mg dL...

Page 66: ...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 Solutio...

Page 67: ...eaning the meter please follow the guidelines listed below Dilute Bleach A 10 solution of household bleach Sodium Hypochlorite may be used 70 Isopropyl rubbing Alcohol may be used Commercial surface d...

Page 68: ...r 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 m...

Page 69: ...by any party other than an authorized Nova representative or any force of nature B Work which in the sole and exclusive opinion of Nova is impractical to perform because of location alterations in th...

Page 70: ...ps and quality control solutions are warranted to be free of defects until the end of the expiration date or 90 days after the date opened The item must be placed into service prior to the expira tion...

Page 71: ...XCLUSIVE LIABILITY AND BUYER S EXCLUSIVE REMEDY FOR ANY CLAIM OF DAMAGES IN CONNECTION WITH THE SALE OR FURNISHING OF GOODS OR PARTS THEIR DESIGN SUITABILITY FOR USE INSTAL LATION OR OPERATION NOVA BI...

Page 72: ...68...

Page 73: ...l KK B 3F Omori Bellport 26 Minami Oi 6 chome Shinagawa ku Tokyo 140 0013 Japan Tel 813 5471 5461 Nova Biomedical France Parc Technopolis B t Sigma 3 avenue du Canada 1er tage Les Ulis courtaboeuf 919...

Page 74: ...54 9141 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 i...

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