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Ketone Methodology

The ketone measurement is based on the following

methodology:

Enzyme

1. D-3-hydroxybu NAD ––––––> Acetoacetate
+ NADH + H

2. Mediator (ox) + NADH –––––> Mediator (red) + NAD

-e

3. Mediator (red) ––––––> Mediator (ox)

The current generated at the electrode is proportional to the

ketone concentration of the sample.

Appendix

Summary of Contents for StatStrip Xpress-i

Page 1: ...Nova StatStrip Xpress i Glucose and Ketone Hospital Meter Instructions for Use Manual For Export Only...

Page 2: ......

Page 3: ...ces 12 Operation Overview 14 Meter Sleep Wakeup 15 Setup 17 Installing the Battery Replacing 17 Set the Time 19 Set Date Format 22 Beeper On or Off 26 Testing Glucose QC Linearity Proficiency Blood Sa...

Page 4: ...ty Proficiency Solution 47 Reviewing Test Results 50 Deleting Stored Test Results 51 Troubleshooting 53 Battery Check 53 Error Codes 57 Appendix 61 Specifications 62 Reference Values 64 Glucose Method...

Page 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...

Page 6: ...nd Ketone Hospital Meter is factory set to report glucose results in mg dL or mmol L and ketone results in mmol L Throughout this manual NOTES provide important or helpful operating information CAUTIO...

Page 7: ...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 4 Follow all operatin...

Page 8: ...ropriate 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 the b...

Page 9: ...ecome infectious during the course of use Discard in accordance with local regulations for biohazardous waste Environmental The operating temperature range for Meter operation 5 C to 40 C 41 F to 104...

Page 10: ...6 Nova StatStrip Xpress i Glucose and Ketone Hospital Meter LCD Display Left Arrow Button Mode Button Right Arrow Button Test Strip Results mmol L Glucose Result Ketone Result Results mg dL...

Page 11: ...Indicator Blood or Control Drop Indicator Test Result mmol L Beeper ON Indicator Glucose Test Result AM or PM Indicator Date Day Hour Minute Nova StatStrip Xpress i Glucose and Ketone Hospital Meter...

Page 12: ...for in vitro diagnostic use by health care professionals and for point of care usage in the quantitative measurement of Glucose Glu in fresh capillary venous arterial and neonate whole blood and the...

Page 13: ...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 capa ble of transmitting viral diseases even...

Page 14: ...ment that works in conjunction with Nova Biomedical electrochemical test strips to measure glucose and ketone in a whole blood sample a Quality Control QC solution linearity or proficiency solutions T...

Page 15: ...sm disturbances including diabetes mellitus and idiopathic hypoglycemia and of pancreatic islet cell carcinoma Ref 1 Burtis Carl A and Ashwood Edward R ed 1999 Tietz Textbook of Clinical Chemistry Phi...

Page 16: ...cid 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 D Galactose 350 0 19 4 Hematocrit RBC 65 Ibuprofen 48 0 2 33 L Dopa 100 0 5 07 Intro...

Page 17: ...0 0 1 32 Acetone 10 1 72 Aceteactate 10 0 93 Ascorbic Acid 20 1 14 Bilirubin 10 0 18 Captopril 10 0 46 Cholesterol 500 12 9 Creatinine 6 0 53 Dopamine 10 0 53 Ephedrine 0 9 0 035 Glucose 900 50 0 Intr...

Page 18: ...ts are obtained in 6 seconds for glucose and 10 seconds for ketone Prior to analysis the operator may designate the test sample as a quality control sample level C1 C2 or C3 Test results are automatic...

Page 19: ...t 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 M...

Page 20: ...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 21: ...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 Install Replace the battery as follows...

Page 22: ...or 3 seconds then the screen will go blank CAUTION Upon installing the battery the meter software version is displayed for 3 seconds Software versions may be numeric example 5 0 therefore please exerc...

Page 23: ...utton for longer than 3 seconds The meter if in Sleep Mode wakes up and enters the SETUP Mode 2 Select the hour flashing format either 12 Hr or 24 Hr Press the Right Left Arrow buttons to toggle betwe...

Page 24: ...e 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 6 Press t...

Page 25: ...21 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 Setup...

Page 26: ...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 27: ...23 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 28: ...24 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 29: ...25 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 30: ...26 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...

Page 31: ...27 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 32: ...Proficiency Solution and blood samples Testing a Glucose Quality Control Solution 1 Insert a glucose test strip into the meter All seg ments of the screen will display for 2 seconds Then a flashing b...

Page 33: ...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 soluti...

Page 34: ...screen in 6 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 Glucose Quality Control So...

Page 35: ...ion test results are within expected range 1 Insert a glucose test strip into the meter All seg ments of screen will display for 2 seconds Then a flashing blood drop will display NOTE If strip is re m...

Page 36: ...y 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...

Page 37: ...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 Glucose test results are available on screen in 6 second...

Page 38: ...34 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 Glucose Blood Sample Result in mmol L Result in mg dL...

Page 39: ...n 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 Glucose Blood Sample HI Result LO Resu...

Page 40: ...reen will display for 2 seconds Then a flashing blood drop will display 2 Touch the end of the test strip to a drop of linearity solution or proficiency solution until the test strip fills and the met...

Page 41: ...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 profi...

Page 42: ...lucose 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 L R...

Page 43: ...n Proficiency Solution and blood samples Testing a Ketone Quality Control Solution 1 Insert a ketone test strip into the meter All segments of the screen will display for 2 seconds Then a flashing blo...

Page 44: ...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 solut...

Page 45: ...vailable on screen in 10 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 Ketone Qualit...

Page 46: ...ion test results are within expected range 1 Insert a ketone 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 mov...

Page 47: ...vely 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 5 Squeeze...

Page 48: ...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 Ketone test results are available on screen in 10 seconds Testing a Ketone Blo...

Page 49: ...45 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 Ketone Blood Sample Result in mmol L...

Page 50: ...ater 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 Ketone Blood Sample HI Result...

Page 51: ...will display for 2 seconds Then a flashing blood drop will display 2 Identify the sample as a Control use the Left or Right button to find the desired control level C1 for L1 or L2 C2 for L3 or C3 for...

Page 52: ...olution until the test strip fills and the meter beeps NOTE A quick beep sounds when sufficient linearity proficiency solution has been added to the test strip 4 Linearity or proficiency test results...

Page 53: ...here 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 Ketone Linearity Proficiency Solution Result in m...

Page 54: ...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...

Page 55: ...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...

Page 56: ...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 57: ...e Nova StatStrip Xpress i Glucose Ketone 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...

Page 58: ...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 59: ...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 60: ...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...

Page 61: ...ays 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 Software...

Page 62: ...est again If you get the same error con tact your local Nova distributor E2 Operating Temperature Error The Meter temperature is outside of the range for testing Action Move the meter to an area where...

Page 63: ...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...

Page 64: ...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...

Page 65: ...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 66: ...ne Methodology Enzyme Amperometric Test Results mmol L Sample Type Whole blood Glucose Test Range 10 to 600 mg dL or 0 6 to 33 3 mmol L Ketone Test Range 0 0 to 8 0 mmol L Test Time 6 seconds Glu 10 s...

Page 67: ...rial or USB Operating Ranges Temperature 5 to 40 C 41 to 104 F 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 4x...

Page 68: ...e used only as a guide Fasting Glucose1 3 6 5 3 mmol L 64 9 95 5 mg dL Fasting Ketone2 3 0 02 0 27 mmol L 1 Burtis Carl A and Ashwood Edward R ed 1994 Tietz Textbook of Clinical Chemistry Philadelphia...

Page 69: ...hodology 1 Glucose Enzymes oxidized form Gluconic Acid Enzymes reduced form 2 Enzymes reduced form Ferricyanide Enzymes oxidized form Ferrocyanide e 3 Ferrocyanide Ferricyanide Electrode The current g...

Page 70: ...on the following methodology Enzyme 1 D 3 hydroxybutyrate NAD Acetoacetate NADH H 2 Mediator ox NADH Mediator red NAD e 3 Mediator red Mediator ox The current generated at the electrode is proportion...

Page 71: ...Linearity Solutions Levels 1 2 3 4 5 Chemistry Measurement The typical imprecision for glucose and ketone both for within run and day to day in mmol L mg dL Glucose Levels Glucose Levels CV mg dL mmo...

Page 72: ...68 Ketone Levels CV mmol L or S D 1 0 20 mmol L S D 3 7 5 5 7 5 Appendix...

Page 73: ...etone Hospital Meter are available from Nova Bio medical DESCRIPTION Instructions for Use Manual 46952 Quick Reference Guide 46963 StatStrip Glucose Test Strips 42214 Nova StatStrip Glucose and Ketone...

Page 74: ...70 Nova StatStrip Glucose and Ketone Control Solution Level 3 46949 Nova StatStrip Glucose and Ketone Linearity Kit 46950 StatStrip Ketone Test Strips 46951 Battery DL2450 41221 Appendix...

Page 75: ...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 deconta...

Page 76: ...h a disin fectant 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...

Page 77: ...ions electric current fluctuations work performed 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...

Page 78: ...following exceptions apply Consumable items including the Ketone Test Strips and quality control solutions are warranted to be free of defects until the end of the expiration date or 90 days after th...

Page 79: ...NTIES OF MERCHANTABILITY OR OTHERWISE EXPRESSED OR IMPLIED IN FACT BY LAW AND STATE OUR ENTIRE AND EXCLUSIVE LIABILITY AND BUYER S EXCLUSIVE REMEDY FOR ANY CLAIM OF DAMAGES IN CONNECTION WITH THE SALE...

Page 80: ...76...

Page 81: ...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 Authorized Representative Nova Biomedical UK Telephon...

Page 82: ...00 Waltham MA 02454 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 1 497 446 1 497 449 JP 4060078 Made in the USA by N...

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