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NOVA BIOMEDICAL StatStrip Xpress, Инструкция по эксплуатации

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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. The Nova StatStrip Xpress Lactate Hospital 

Meter System is intended for use in a clinical setting by 

health care professionals as an aid to evaluate the acid-

base status of patients suspected of having lactic acidosis. 

Содержание StatStrip Xpress

Страница 1: ...Nova StatStrip Xpress Lactate Hospital Meter Instructions for Use Manual For Export Only...

Страница 2: ......

Страница 3: ...y 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...

Страница 4: ...g 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 5...

Страница 5: ...c medical device REP EC Authorized Representative in the European Community Product fulfills the requirements of Directive 98 79 EC IVDD Caution consultaccompanying documents Consult instructions for...

Страница 6: ...ure 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 importa...

Страница 7: ...e 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 instructions...

Страница 8: ...dard hospital procedures 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...

Страница 9: ...with local regulations for biohazardous waste Environmental Operating temperature range 59 F to 104 F 15 C to 40 C Relative humidity range 10 to 90 non condensing The maximum altitude for Meter operat...

Страница 10: ...6 Nova StatStrip Xpress Lactate Hospital Meter LCD Display Left Arrow Button Mode Button Right Arrow Button Lactate Test Strip mmol L Result in mmol L Test Strip Ejector Push Up to Eject...

Страница 11: ...ow Battery Indicator Blood or Control Drop Indicator Test Result mmol L Beeper ON Indicator Lactate Test Result AM or PM Indicator Date Day Hour Minute Nova StatStrip Xpress Lactate Hospital Meter Scr...

Страница 12: ...titative determination of Lactate Lac in fresh venous and arterial whole blood It is intended to provide plasma equivalent results to labora tory methods The Nova StatStrip Xpress Lactate Hospital Met...

Страница 13: ...ared to help you attain optimum performance from your Meter WARNING Blood samples and blood products are potential sources of infectious agents Handle all blood products and strips with care Gloves an...

Страница 14: ...only the Nova StatStrip Lactate Test Strips with the Nova StatStrip Lactate Meter If test result is higher or lower than expected run a control solution test Remove the test strip from the vial only w...

Страница 15: ...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 co...

Страница 16: ...test strips to measure lactate 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 The us...

Страница 17: ...tatus 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 B Saunders Co The Sample Venous and Arter...

Страница 18: ...dL mmol L Acetaminophen 20 0 0 66 Ascorbic Acid 10 0 0 57 Bilirubin 15 0 0 26 Cholesterol 500 0 12 9 Creatinine 6 0 0 53 Dopamine 10 0 0 53 Ephedrine 0 9 0 055 Glucose 900 0 49 7 Ibuprofen 48 0 2 33...

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

Страница 20: ...ttery 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 batt...

Страница 21: ...owing 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...

Страница 22: ...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 Install Replace the battery as follows 1 Remove th...

Страница 23: ...e 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 batt...

Страница 24: ...t The software version and the default date and time will appear for 3 seconds 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 M...

Страница 25: ...ton to accept the Hour Format 4 The meter displays the current time or the default time with the hour digits flashing 5 PresstheRight LeftArrow buttonstoscrollfrom1AM to 12PM for 12 Hr Clock or 0 to 2...

Страница 26: ...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 Mi...

Страница 27: ...rmat 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 Press the MODE button t...

Страница 28: ...24 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 29: ...25 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 30: ...26 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 31: ...27 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 Setup...

Страница 32: ...28 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 33: ...c 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 during each 24 hours of tes...

Страница 34: ...stitution 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 Testing a Q...

Страница 35: ...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 Then a flashing...

Страница 36: ...the desired control level C1 and C2 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 sol...

Страница 37: ...re available on screen in 13 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 Testing a Quality C...

Страница 38: ...ion 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 befo...

Страница 39: ...whole blood sample 4 Use either a syringe or a pipette to add a blood drop to the Lactate test strip 5 When the blood drop appears touch the end of the test strip to the blood drop until the test stri...

Страница 40: ...36 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 Testing a Blood Sample Result in mmol L...

Страница 41: ...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 Testing a Blood Sample HI Lact...

Страница 42: ...ess 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 Then a flashing blood drop w...

Страница 43: ...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 44: ...Testing 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 mmol...

Страница 45: ...he 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 button...

Страница 46: ...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 The screen displays the number...

Страница 47: ...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 48: ...or 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...

Страница 49: ...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 50: ...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 51: ...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 Batter...

Страница 52: ...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 53: ...he 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...

Страница 54: ...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 test with a...

Страница 55: ...rip 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 Action Repeat the test with a new test strip If...

Страница 56: ...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 57: ...hodology 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 L Memory storage 400...

Страница 58: ...5 g Size 3 6x2 3x0 9 in 91 4x58 4x22 9 mm Reference Values Each laboratory should establish and maintain its own reference value The value given here should be used only as a guide Lactate1 0 7 2 5 mm...

Страница 59: ...e measurement is based on the following methodology 1 L Lactate LODox Pyruvate LODred 2 LODred Fe CN 6 3 LODox Fe CN 6 4 e 3 Fe CN 6 4 Fe CN 6 3 The current generated at the electrode is proportional...

Страница 60: ...on 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 CV mmol L 0 76 9 1 2 16 5 9 10...

Страница 61: ...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...

Страница 62: ...cleaning 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...

Страница 63: ...ing 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 authoriz...

Страница 64: ...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 the Nova equipment or connec tion of the...

Страница 65: ...ed 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 date printed on the packaging Freight is pa...

Страница 66: ...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 67: ...Vienna Austria Tel 43 1 603 09700 Nova Biomedical KK B 3F Omori Bellport 26 Minami Oi 6 chome Shinagawa ku Tokyo 140 0013 Japan Tel 813 5471 5461 REP EC EU Authorized Representative Nova Biomedical U...

Страница 68: ...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 Biomed...

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