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NOVA BIOMEDICAL Nova StatSensor Xpress-i, Инструкция по эксплуатации

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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. Not for use in neonates.

The Sample

•  Capillary, venous, and arterial whole blood

•  Plasma calibrated patient test results

•  Sample size 1.2 µL

•  Anticoagulants: sodium, lithium, and ammonium heparin

Содержание Nova StatSensor Xpress-i

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

Страница 2: ......

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 72: ...68...

Страница 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...

Страница 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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