Lifescan OneTouch SS Xpress Instructions For Use Manual
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Lifescan OneTouch SS Xpress Instructions For Use Manual

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Glucose Hospital Meter
Instructions for Use Manual

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  • Page 1 Glucose Hospital Meter Instructions for Use Manual...

  • Page 3: Table Of Contents

    Table of Contents Symbols .................1 About This Manual ..............2 Introduction ................3 Important Safety Instructions ..........6 Blood-Borne Pathogens Safety ..........6 General Safety ..............9 Electrical Safety ...............10 Chemical and Biological Safety ........11 Environmental ..............12 Intended Use ...............13 Limitations ................14 Precautions................16 The Sample .................18 Interfering Substances............21 Glucose Interferences ............21...
  • Page 4 Table of Contents Operation Overview .............28 Meter Sleep/Wakeup ............29 Setup ...................31 Installing the Battery (Replacing) ........31 Set the Time ..............33 Set Date Format ...............36 Beeper On or Off ..............40 Testing: QC/Blood Samples..........42 Testing a Quality Control Solution ........43 Patient Samples ...............49 Important Safety Instructions ...........49 Testing A Blood Sample ...........52 Reviewing Test Results ............57...
  • Page 5 Table of Contents Troubleshooting ..............66 Battery Check ..............66 Error Codes ..............70 Appendix................75 Specifications ..............76 Reference Values .............78 Glucose Methodology ............79 Quality Control Solution ...........80 Chemistry Measurement ..........80 Results of Multi-Center Clinical Study ......81 Clinical Study Performance ..........91 Medical Condition Analysis Summary Tables ....97 Parent Drug Class Summary Tables ......126 Ordering Information ............150...

  • Page 7: Symbols

    Symbols The following are symbols that are used in this manual, on insert sheets, on the product packaging and labelling, and on the meter. Lot Number In vitro diagnostic medical device Serial Number Product fulfills the Temperature limitation requirements of Directive 98/79 EC (IVDD) Manufacturer Caution, consult Biological Risk...

  • Page 8: About This Manual

    About This Manual This manual is for the OneTouch® StatStrip Xpress® Glucose Hospital Meter. Unit of Measure Information The unit of measure of the OneTouch StatStrip Xpress Glu- cose Hospital Meter is set to report glucose results in mg/dL, P/N 023330, or mmol/L, P/N 023324 and can not be changed. Separate Result screens and specifications are shown in the Instructions for Use Manual for each unit of measure.

  • Page 9: Introduction

    Introduction This manual provides all necessary instructions for the rou- tine operation and maintenance of the OneTouch StatStrip Xpress Glucose Hospital Meter System. Please read this manual carefully. It has been prepared to help you attain optimum performance from your Meter. CAUTION: Capillary whole blood specimens (e.g.
  • Page 10 Introduction This section introduces the meter and covers requirements, tests performed, procedural limitations, clinical utility, and sample handling. The OneTouch StatStrip Xpress Glucose Hospital Meter is a hand-held, battery-powered, in vitro diagnostic labora- tory instrument that works in conjunction with OneTouch StatStrip glucose test strips to measure glucose in a whole blood sample, a Quality Control (QC) solution, linearity, or proficiency solutions. In addition to measuring glucose,...
  • Page 11 Introduction all stored test results on screen. Functions and data selec- tion are accomplished by 3 push buttons. The meter has a built-in beeper for audible alerts and prompts. Depending on geography, the OneTouch StatStrip Xpress Glucose Hospital Meter is hard-coded to display glucose results in mg/dL or mmol/L units.

  • Page 12: Important Safety Instructions

    Important Safety Instructions Blood-Borne Pathogens Safety 1. Healthcare professionals and others using this sys- tem should adhere to Standard Precautions when handling or using the OneTouch StatStrip Xpress Glucose Hospital Meter System. 2. Healthcare professionals should be aware that all parts of the OneTouch StatStrip Xpress Glucose Hospital Meter System are considered potentially infectious and can potentially transmit blood-borne...
  • Page 13 Important Safety Instructions fected after use on each patient following the Clean- ing and Disinfecting Procedure. Healthcare profes- sionals should wear a new pair of protective gloves before testing each new patient. 4. Only auto-disabling, single-use lancing devices may be used with this system. 5.
  • Page 14 Important Safety Instructions “Protection of Laboratory Workers From Occupation- ally Acquired Infections; Approved Guideline-Third Edition,” Clinical and Laboratory Standards Institute (CLSI) M29-A3. “FDA Public Health Notification: Use of Fingerstick Devices on More than One Person Poses Risk for Tranmitting Bloodborne Pathogens: Initial Commu- nication.”...

  • Page 15: General Safety

    Important Safety Instructions General Safety 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 operat- ing instructions. 4. Follow all operating and use instructions. 5.

  • Page 16: Electrical Safety

    Important Safety Instructions Electrical Safety • Battery powered: 3 V coin battery Disposal of Used Batteries • The battery provided with the meter should not be treated as household waste. To ensure the used battery is treated properly, remove the used battery from the meter and hand over the used battery to the applicable battery waste collection point.

  • Page 17: Chemical And Biological Safety

    Important Safety Instructions Disposal of Used Meters • The meter may become infectious during the course of use. Discard in accordance with local regulations for biohazardous waste. Chemical and Biological Safety • Observe all precautionary information printed on the original solution containers. •...

  • Page 18: Environmental

    Important Safety Instructions Environmental • The operating temperature range for Meter operation: 15˚C to 40˚C (59˚F to 104˚F) • The relative humidity range for Meter operation: 10% to 90% non-condensing • The maximum altitude for Meter operation: Up to 4500 meters (15,000 feet) Dimensions: Height: 91.4mm (3.6in) Width: 58.4mm (2.3in) Depth: 22.9mm (0.9in) Weight: 75 g (2.65 oz)

  • Page 19: Intended Use

    Intended Use Intended Use The OneTouch StatStrip Xpress Glucose Hospital Meter System is intended for point-of-care, in vitro diagnostic, multiple-patient use for the quantitative determination of glucose in capillary finger stick, venous whole blood, arterial whole blood, neonate arterial whole blood, and neonate heel stick specimens. The OneTouch StatStrip Xpress Glucose Hospital Meter System is also intended for use in the quantitative determina- tion of glucose in venous whole blood, arterial whole blood, neonatal heel stick and neonatal arterial whole blood samples...

  • Page 20: Limitations

    Intended Use It is not intended for use with neonate cord blood speci- mens. It is not intended for the screening or diagnosis of diabetes mellitus but is indicated for use in determining dysglycemia. Limitations • Capillary whole blood specimens (e.g. obtained by finger stick) should not be used in patients receiving intensive medical intervention/therapy because of the potential for pre-analytical collection error and specifi-...
  • Page 21 Limitations • The system has not been evaluated for use with neonate venous blood. • Blood source - Use only whole blood. Do not use serum or plasma. • Temperature and humidity extremes - Test results may be inaccurate when test strips are stored out- side of the storage and handling conditions.

  • Page 22: Precautions

    Precautions • Prior to use, read the Instructions for Use Manual. • DO NOT reuse test strips. Test strips should be dis- posed after a single use. • Discard used test strips according to local regula- tions. • Remove the test strip from the vial only when ready to test.
  • Page 23 Precautions • Do not tamper with the test strip. • If test result is higher or lower than expected, follow institutional policy or run a control solution test to confirm test strip performance. 1. If control solution result is out of range, remove test strip vial from point of use and repeat control solution test with new test strip vial.

  • Page 24: The Sample

    The Sample • Capillary whole blood (finger stick), venous whole blood, arterial whole blood, neonate heel stick, and neonate arterial whole blood specimens • Venous whole blood, arterial whole blood, neona- tal heel stick, and neonatal arterial whole blood samples throughout all hospital and all professional healthcare settings •...
  • Page 25 Glucose Test Strip LCD Display Ejector Button Push Up mg/dL mmol/L Left Arrow Button Right Arrow Button Mode Button Result in mg/dL Result in mmol/L OneTouch StatStrip Xpress Glucose Hospital Meter...
  • Page 26 Glucose Beeper ON Blood or Control Indicator Drop Indicator Glucose Test Result Low Battery Indicator Test Result mg/dL or mmol/L Note: This screen Memory indicates all that could possibly be shown. “No.” AM or PM is not used or Indicator Date/Day Hour/Minute displayed.

  • Page 27: Interfering Substances

    Interfering Substances Glucose Interferences: The OneTouch StatStrip Xpress Glucose Hospital Meter Sys- tem exhibits no interference from the following list of drugs or physiological conditions commonly found in patients in intensive care settings with complex medical conditions and drug regiments up to the following concentration levels: Tested Tested Interfering Substances...
  • Page 28 Interfering Substances Tested Tested Interfering Substances Concentration Level Ascorbic Acid 22.5 mg/dL 1.278 mmol/L Atropine 0.01 mg/dL 0.000346 mmol/L Beta-hydroxybutyrate 166.6 mg/dL 16 mmol/L Bilirubin 297.3 mg/dL 5 mmol/L Captopril 0.6 mg/dL 0.0276 mmol/L Carbamazepine 1 mg/dL 0.0423 mmol/L Cefaclor 35 mg/dL 0.952 mmol/L Cholesterol...
  • Page 29 Interfering Substances Tested Tested Interfering Substances Concentration Level Enalapril 0.5 mg/dL 0.0133 mmol/L Ephedrine 1 mg/dL 0.0605 mmol/L Ethanol 399.9 mg/dL 86.8 mmol/L Famotidine 0.042 mg/dL 0.0012 mmol/L Fluconazole 2 mg/dL 0.0653 mmol/L Fluoxetine Hydrochloride 2 mg/dL 0.0647 mmol/L Fructose 500 mg/dL 27.75 mmol/L Furosemide...
  • Page 30 Interfering Substances Tested Tested Interfering Substances Concentration Level Hydrocortisone 20 mg/dL 0.552 mmol/L Ibuprofen 48.0 mg/dL 2.33 mmol/L Ketoprofen 6 mg/dL 0.236 mmol/L Lactose 500 mg/dL 14.61 mmol/L Lansoprazole 20 mg/dL 0.542 mmol/L L-dopa 100 mg/dL 5.07 mmol/L Levofloxacin 1.8 mg/dL 0.0498 mmol/L Lidocaine 0.7 mg/dL...
  • Page 31 Interfering Substances Tested Tested Interfering Substances Concentration Level Methyl-dopa 1.0 mg/dL 0.042 mmol/L Metoprolol Tartrate Salt 1.8 mg/dL 0.0673 mmol/L N-acetylcysteine 81.6 mg/dL 5 mmol/L Naproxen 40 mg/dL 1.74 mmol/L Nifedipine 0.02 mg/dL 0.00058 mmol/L Norepinephrine 10 mg/dL 0.591 mmol/L Nortriptyline Hydrochloride 0.02 mg/dL 0.00076 mmol/L...
  • Page 32 Interfering Substances Tested Tested Interfering Substances Concentration Level Ranitidine hydrochloride 1 mg/dL 0.032 mmol/L Salicylate 120.0 mg/dL 8,67 mmol/L Sodium Chloride Deviation from a normal sodium 23.8 mg/dL 40 mmol/L or chloride level Sodium Nitroprusside dihydrate 0.05 mg/dL 0.0019 mmol/L Sorbitol 500 mg/dL 27.45 mmol/L...
  • Page 33 Interfering Substances Tested Tested Interfering Substances Concentration Level Uric Acid 23.5 mg/dL 1.4 mmol/L Vancomycin hydrochloride 3 mg/dL 0.021 mmol/L hydrate Verapamil Hydrochloride 0.1 mg/dL 0.0022 mmol/L Warfarin 1.2 mg/dL 0.039 mmol/L Xylose 500 mg/dL 33.3 mmol/L Hematocrit 20% and 70% Oxygen All concentrations 6.6 and 8.0...

  • Page 34: Operation Overview

    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 6 seconds. •...

  • Page 35: Meter Sleep/Wakeup

    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. Meter Sleep/Wakeup The LCD display is turned off to conserve battery power (sleep mode) after one minute of no activity.
  • Page 36 Meter Sleep/Wakeup 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 37: Setup

    Setup This section describes how to setup the OneTouch StatStrip Xpress Glucose Hospital 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. Installing the Battery (Replacing) The meter is powered by a single 3V coin cell battery.
  • Page 38 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 may be numeric (example 1.0); therefore, please exercise caution to ensure the software version is not reported as a glucose result.

  • Page 39: 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 40 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. 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).
  • Page 41 Setup 8. Press the MODE button to accept the displayed Minutes choice.

  • Page 42: Set Date Format

    Setup Set Date Format 1. Next set the date format. The display is 1-31 2015 or 31.01.2015. 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 43 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 44 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 45 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 46: Beeper On Or Off

    Setup 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 47 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 48: Testing: Qc/Blood Samples

    Testing: QC/Blood Samples This section describes how to run QC (Quality Control), Linearity Solution, Proficiency Solution, and blood samples. When to Perform a QC Test The OneTouch StatStrip Xpress Glucose Hospital Meter includes several quality control mechanisms that detect errors due to system failures and operator performance. External controls materials are available for verifying the integrity of the OneTouch StatStrip Xpress Glucose Hospital Meter.

  • Page 49: Testing A Quality Control Solution

    Testing a Quality Control Solution OneTouch StatStrip Glucose Control Solution Read the OneTouch StatStrip Glucose Control Solution package insert sheet for complete instructions, indications, precautions, and limitations of the system. Only the OneTouch StatStrip Glucose Control Solutions are recommended for use with the OneTouch StatStrip Xpress Glucose Hospital Meter and the OneTouch StatStrip Glu- cose Test Strips.
  • Page 50 Testing a Quality Control Solution • During institutional training of each new operator • Before using for the first time • If a patient test has been repeated and the blood glucose results are still lower or higher than expect- • If there are other indications that the system is not working properly •...
  • Page 51 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 52 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. Gently mix the OneTouch StatStrip Glucose Control Solution before each use. 4. Discard the first drop of control solution from the bottle to avoid contamination. 5. Touch the end of the test strip to a drop of control solution until the test strip fills and the meter beeps (if beeper is switched on).
  • Page 53 Testing a Quality Control Solution NOTE: A quick beep sounds when sufficient control solution has been added to the test strip. 6. Recap the control solution. 7. Glucose quality control test results are available on- screen in 6 seconds. Result Result Displayed Displayed in in mg/dL...
  • Page 54 Testing a Quality Control Solution 9. Remove the test strip and discard into an appropriate biohazard container. NOTE: Acceptable control assay ranges are printed on the Glucose Control Solutions vial label. If a QC test does not fall within the specified range, verify that the OneTouch StatStrip Glucose Hospital Test Strips and OneTouch StatStrip Glucose Control Solutions are not past their expiration dates.

  • Page 55: Patient Samples

    Patient Samples This section describes how to perform patient tests with the OneTouch StatStrip Xpress Glucose Hospital Meter System. NOTE: A linearity solution/proficiency test is performed in the same way as performing a patient sample. Important Safety Instructions Standard Precautions should be adhered to when handling or using the OneTouch StatStrip Xpress Glucose Hospital Meter System to reduce the risk of disease transmission.
  • Page 56 Important Safety Instructions The OneTouch StatStrip Xpress Glucose Hospital Meter System may only be utilized for testing on multiple patients when Standard Precautions are followed and when the system is cleaned and disinfected after use on each patient following the procedure in Cleaning and Disinfecting the Meter section.
  • Page 57 Important Safety Instructions ally Acquired Infections; Approved Guideline-Third Edition,” Clinical and Laboratory Standards Institute (CLSI) M29-A3. 3. “FDA Public Health Notification: Use of Fingerstick Devices on More than One Person Poses Risk for Tranmit- ting Bloodborne Pathogens: Initial Communication.” (2010) http://www.fda.gov/Medicaldevices/Safety/AlertsandNotices/ ucm224025.html. 4. “CDC Clinical Reminder: Use of Fingerstick Devices on More than One Person Poses Risk for Transmitting Blood- borne Pathogens.”...

  • Page 58: 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. Verify that all seg- ments of the screen display. If the display is incom- plete, discontinue use for diagnostic testing.
  • Page 59 Testing a Blood Sample 2. Wash patient's hand with water then dry thoroughly. Al- ternatively, use alcohol pads to clean area; dry thoroughly after cleaning. 3. Holding hand downward, massage finger with thumb toward tip to stimulate blood flow. 4. Use a safety lancet to punc- ture the finger.
  • Page 60 Testing a Blood Sample 6. When the blood drop ap- pears, touch the end of the test strip to the blood drop until the test strip fills and the meter beeps. WARNING: The test strip must fill completely upon touching the blood droplet. If the test strip does not fill completely, do not touch the test strip to the blood droplet a second time.
  • Page 61 Testing a Blood Sample 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 Result in mg/dL Result in mmol/L test strip. 9. Remove the test strip and discard into an appropri- ate biohazard container.
  • Page 62 Testing a Blood Sample a new patient. For instructions, see Cleaning and Disinfecting the Meter section in this manual. 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 mmol/L NOTE: Test results are automatically saved.

  • Page 63: Reviewing Test Results

    Reviewing 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 dis- plays - - - on the mem (memory) screen.

  • Page 64: Deleting Stored Test Results

    Deleting Stored Test Results 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 simultane- ously for longer than 3 seconds.
  • Page 65 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 66: Cleaning And Disinfecting The Meter

    Cleaning and Disinfecting the Meter The OneTouch StatStrip Xpress Glucose Hospital Meter should be cleaned and disinfected after each patient use to minimize the risk of transmission of blood-borne pathogens between patients and healthcare professionals. Healthcare professionals and others should follow Good Laboratory Practice guidelines and these important safety instructions.
  • Page 67 Cleaning and Disinfecting the Meter Acceptable Cleaning and Disinfecting Materials LifeScan recommends the use of Clorox Healthcare® Bleach Germicidal Wipes, EPA Registration #67619-12, or any disinfectant product with EPA Registration #67619-12 may be used. The OneTouch StatStrip Xpress Glucose Hospital Meter...
  • Page 68 Cleaning and Disinfecting the Meter Prepare Make sure the test strip is removed from the meter. Lay the meter on a flat surface prior to cleaning and disinfecting the meter. WARNING: To ensure proper disinfection, it is important to clean the meter (Step 1) prior to disinfecting the meter (Step 2). 1.
  • Page 69 Cleaning and Disinfecting the Meter 2. Disinfect the Meter. • Using a new, fresh germicidal bleach wipe, thoroughly wipe the surface of the meter (top, bottom, left, and right sides) a minimum of 3 times horizon- tally followed by 3 times vertically avoiding the electrical connector.

  • Page 70: Additional Information

    Cleaning and Disinfecting the Meter 4. Dispose of wipe and gloves. • Dispose of used wipe and gloves in a standard biohazard container. 5. Wash and sanitize hands. • Wash your hands thoroughly with soap and water, and put on a fresh set of protective gloves before proceeding to perform testing on the next patient.
  • Page 71 Signs of meter performance deterioration may include failure to recover proper control solution results or the inability to perform a blood glucose test. If you observe damage due to cleaning and disinfection, stop using the meter and contact LifeScan Customer Service.

  • Page 72: Battery Check

    Troubleshooting This section describes Battery status, Error Codes, and Ac- tions for the OneTouch StatStrip Xpress Glucose Hospital Meter. Battery Check The battery provides sufficient power to operate for approxi- mately 600 tests. A battery low warning will alert the user to replace the battery. Test results are stored in non-volatile memory to prevent test result loss.
  • Page 73 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. Continue with testing as usual.
  • Page 74 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 75 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. Battery Icon CAUTION: Attempts to perform glucose testing with a low battery could result in the software rebooting.

  • Page 76: 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 77 Troubleshooting E1 System Hardware Error A system hardware error has been detected. Action: Perform the test again. If you get the same error, please contact your local customer service representative, details can be found at www.onetouchstatstrip.com. E2 Operating Temperature Error The Meter temperature is outside of the range for testing.
  • Page 78 Troubleshooting 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 Solu- tion or blood) was drawn into the test strip.
  • Page 79 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. E8 Bad Strip Error The test strip is defective or bad.
  • Page 80 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.

  • Page 81: Appendix

    Appendix Appendix The Appendix includes solution and reagent specifications, accuracy and precision, and reference information.

  • Page 82: Specifications

    Appendix Specifications Acceptable Sample • Capillary whole blood (finger stick), venous whole blood, arte- rial whole blood, neonate heel stick, and neonate arterial whole blood specimens • Venous whole blood, arterial whole blood, neonatal heel stick, and neonatal arterial whole blood samples throughout all hospital and all professional healthcare settings Measuring Technology Enzyme, Amperometric Glucose Enzyme (Aspergillus sp.,>1.0 IU)
  • Page 83 Appendix Test Time 6 seconds Test Strip Volumes 1.2 µL Memory storage 400 Tests Battery Life (nominal) 600 Tests Battery Type 2450 3V coin cell Operating Ranges: Temperature 15°C to 40°C (59°F to 104°F) Humidity 10 to 90% (noncondensing) Altitude Up to 4572 meters (15,000 ft) Weight 75 g (2.65 oz)

  • Page 84: Reference Values

    Appendix Reference Values Each laboratory should establish and maintain its own reference value. The value given here should be used only as a guide. Test Value Glucose Less than 100 mg/dL (5.55 mmol/L) Normal Fasting Less than 140 mg/dL (7.77 mmol/L) 1-2 hours after meals American Diabetes Association. Diagnosis and Classification of Diabetes Mellitus.

  • Page 85: Glucose Methodology

    Appendix Glucose Methodology The glucose measurement is based on the following methodology: 1. Glucose + Enzymes(oxidized form) ––– > Gluconic Acid + Enzymes(reduced form) 2. Enzymes(reduced form) + Ferricyanide –– > Enzymes(oxidized form) + Ferrocyanide 3. Ferrocyanide ————— > Ferricyanide Electrode The current generated at the electrode is proportional to the glucose concentration of the sample.

  • Page 86: Quality Control Solution

    Appendix Quality Control Solution Control Solutions Levels 1, 2, 3 Linearity Solutions Levels 1, 2, 3, 4, 5 Chemistry Measurement The typical imprecision for glucose both for within-run and day-to-day Glucose Levels Glucose Levels (mg/dL) (mmol/L) 22.2 33.3...

  • Page 87: Results Of Multi-Center Clinical Study

    Appendix Results of Multi-Center Clinical Study: Patients Requir- ing Intensive Medical Intervention/Therapy Introduction A large multi-center study was conducted at 5 leading medical centers to demonstrate clinical performance within all hospital and all professional healthcare settings on 1,698 different patients requiring intensive medical intervention. A description of the clinical study sites is found below.
  • Page 88 Appendix (927 arterial and 318 venous) from 1,245 different patients. The peripheral arterial and peripheral venous specimens were obtained from patients in medical and surgical units with a mix of critical heart, lung, diabetes, trauma, neurology and gynecological conditions. Patient specimens obtained from the emergency departments include patients with a mix of heart, lung, diabetes, trauma, neurology and gynecological conditions.
  • Page 89 Appendix sion criteria included adult burn patients with 20% or more total body surface area partial/full-thickness burns. The condition of these burn center patients was considered to be extremely critical and complex. The 123 central arterial specimens in- cluded in this clinical study (123) are from six (6) burn patients treated with drugs, therapeutics and treatment programs (high dose Ascorbic Acid) over an extended period of treatment.
  • Page 90 Appendix would see in surgical and cardiovascular intensive care units within a leading university hospital. Clinical study Site #5 is one the world’s preeminent health care institutions located in Maryland. It is a 560 bed universi- ty hospital that includes 33 operating rooms, acute care and intensive care facilities, oncology, obstetrics, pediatric, and neonatal facilities.
  • Page 91 Appendix various clinical settings. The clinical studies included patients throughout all hospital settings involving 19 primary medical condition categories with 257 different medical condition sub- categories. The clinical study patients received approximate- ly 8,000 medications representing 33 parent drug classes and 144 medication sub-classes.
  • Page 92 Appendix • Collection site: (Central or Peripheral draw site) • Patient Demographic Information: (Male or Female, Date of Birth) • Measured Whole Blood Glucose: OneTouch StatStrip Glucose Hospital Meter System • Measured Plasma Glucose: Central laboratory method • Hospital Wards/Divisions: ICU, ED, OR, etc. •...
  • Page 93 Appendix The OneTouch StatStrip system performed consistently independent of the institution, without significant clini- cal interference from drugs, ventilation (O ), endogenous substances, hematocrit, medical condition, medical unit, or patient condition. All arterial and venous patient specimens were analyzed first on the OneTouch StatStrip system and then spun down within 15 minutes to obtain a fresh plasma specimen and measured on the central laboratory method.
  • Page 94 Appendix both Health Care Professionals (HCP’s) and POC operators within the intended use population. A listing of the clinical assessment methods used to evaluate the clinical data is found below. A detailed Medical Condition analysis (based upon World Health Organization medical condition categories) was performed on the clinical data set from all 5 clinical study sites to identify any potential safety issues with the use of the OneTouch StatStrip system within each medical condi- tion subpopulation.
  • Page 95 Appendix Clinical Study Performance section. A detailed Parent Drug Class (based upon U.S. Pharmaco- peia) analysis was performed on the clinical dataset from all 5 clinical study sites to identify any potential safety issues with the use of the OneTouch StatStrip system within the intended use population.
  • Page 96 Appendix An analysis was performed to determine whether speci- men collection site (central or peripheral) or specimen type (arterial or venous) has an impact on the performance of the OneTouch StatStrip system with the intended use population.

  • Page 97: Clinical Study Performance

    Appendix Clinical Study Performance Table A-1 Arterial Specimens Analytical and System Accuracy Comparison: Glucose con- centrations < 75 mg/dL Site Within Within Within Within Exceeds ± 5 mg/dL ±10mg/dL ±12mg/dL ±15mg/dL ±15mg/dL Site #1 64/82 75/82 78/82 79/82 3/82 (78.0%) (91.5%) (95.1%) (96.3%)
  • Page 98 Appendix Site #5 (N/A) (N/A) (N/A) (N/A) (N/A) Combined 163/201 189/201 195/201 197/201 4/201 All Sites (81.1%) (94.0%) (97.0%) (98.0%) (2.0%)
  • Page 99 Appendix Table A-2 Arterial Specimens Analytical and System Accuracy Comparison: Glucose con- centrations > 75 mg/dL Site Within Within Within Within Within Exceeds ± 5% ± 10% ± 12.5% ± 15% ± 20% ± 20% Site #1 362/538 497/538 515/538 523/538 532/538 6/538...
  • Page 100 Appendix Site #5 22/44 41/44 42/44 44/44 44/44 0/44 (50.0%) (93.2%) (95.5%) (100%) (100%) (0.0%) Combined 844/1267 1175/1267 1220/1267 1244/1267 1258/1267 9/1267 All Sites (66.6%) (92.7%) (96.3%) (98.2%) (99.3%) (0.7%)
  • Page 101 Appendix Table A-3 Venous Specimens Analytical and System Accuracy Comparison: Glucose con- centrations < 75 mg/dL Site Within Within Within Within Exceeds ±5 mg/dL ±10 mg/dL ±12 mg/dL ±15 mg/dL ±15 mg/dL Site #1 17/20 20/20 20/20 20/20 0/20 (85.0%) (100%) (100%) (100%)
  • Page 102 Appendix Table A-4 Venous Specimens Analytical and System Accuracy Comparison: Glucose con- centrations > 75 mg/dL Site Within Within Within Within Within Exceeds ± 5% ± 10% ± 12.5% ± 15% ± 20% ± 20% Site #1 77/112 108/112 111/112 111/112 112/112 0/112...

  • Page 103: Medical Condition Analysis Summary Tables

    Medical Condition Analysis Summary Tables The following is a frequency distribution breakdown of the medical conditions based upon World Health Organization medical condition categories included in the clinical study sites: Table A-5 Medical Condition Analysis: Top Level Summary Medical Condition Category Frequency Burn Trauma Cardiac Surgical, Pre &...
  • Page 104 Appendix Obstetrics / Gynecological Oncology Oncology, Surgical Pulmonary Renal Sepsis and Infection Suicide Surgical General Trauma Unknown at time of Patient Test Total* 1,814 * One patient in the clinical database did not include a medical condition.
  • Page 105 Appendix Table A-6 Medical Condition Analysis: Burn Trauma Burn Patient Reason For Hospitalization Condition Frequency 22% TBSA burns 27% TBSA burns 28% TBSA burns 55% TBSA burns 56% TBSA electrical and flame burns 62% TBSA self-inflicted burns Burn Patient Total...
  • Page 106 Appendix Table A-7 Medical Condition Analysis: Cardiac Disease Cardiac Patient Reason For Hospitalization Sub Category Condition Frequency Pre and Post Surgical Observation: Thoracic Surgery Post thoracic surgery Pre-Op Coronary Arterial Angiography Cardiac - Medical Acute coronary syndrome Heart failure Acute Myocardial Infarction Ventricular Rhythm Disorders Arterial Vascular Disease...
  • Page 107 Appendix Artery Disease Bradycardia Cardiac arrest Cardiogenic shock Cardiomyopathy Chronic heart failure Coronary Angiography Endocarditis Cardiac Gangrene Hypertension Myocardial Infarction/Ventricular-Fib Resuscitation Stable Angina...
  • Page 108 Appendix Transient Ischemic Attack Cardiac - Surgical Angiography Endarterectomy Cardio Thoracic (Aortic Bypass Surgery) 12 Cardio Thoracic (Aortic Rupture) Femoral Aneurism Rupture Fibrosing Mediastinitis Obstructive Arteriopathy Pacemaker Surgical Implant Percutaneous Transluminal Ablation (PCTA Stent) Pericardial Surgery (Pericardial Patch) 1 Aortic Aneurism...
  • Page 109 Appendix Thoracic Surgery (Robotic Assisted) Ventricular Septal Rupture AVR/MVR Aortic Stenosis Aortic Valve Replacement Cardio Thoracic (Arterial Valve Replace- ment (↑ Aorta)) Cardio Thoracic (Atrial Fibrillation (Maze + MVP)) Cardio Thoracic (AVR + MVR) Mitral Valve Replacement Cardio Thoracic (AVR + MPL) CABG...
  • Page 110 Appendix CABG surgery Cardio Thoracic (CABG (1 art) + AVR) Cardio Thoracic (CABG (2 art) + AVR) Cardio Thoracic (CABG + AVR + Maze) 4 Cardio Thoracic (CABG + mpl + Maze) 9 Cardio Thoracic (CABG > = 3 art. grafts (incl ven graft) Cardio Thoracic (CABG banned venous grafts)
  • Page 111 Appendix Cardio Thoracic (CABG ven gr or max. 1 art. graft) Cardio Thoracic (Re-CABG) Coronary Artery Disease Total CABG Maze Cardio Thoracic (Maze Procedure) Total All Categories Table A-8 Medical Condition Analysis: Endocrinology Disease Endocrinology Patient Reason For Hospitalization Condition Frequency Acute Kidney Injury...
  • Page 112 Appendix Addison’s Disease Anemia Diabetes Diabetes mellitus Diabetes Mellitus (Uncontrolled) Diabetic ketoacidosis Hyperkalemia Hypocalcemic crisis Hypoxemia Inaugural Diabetes Total...
  • Page 113 Appendix Table A-9 Medical Condition Analysis: Gastroenterological Disease Gastroenterological Patient Reason For Hospitalization Condition Frequency Acute Chronic Liver Failure Adhesive Bowel Obstruction Bleeding Bulbar Ulcer Bleeding Esophagus Constipation Diaphragmatic Hernia Diarrhea Digestive Obstruction Diverticular Peritonitis Gastric Ulcer, Perforated...
  • Page 114 Appendix Hepatitis Observation: Abdominal Discomfort Pancreatitis Peritonitis Small Bowel Obstruction Umbilical Hernia Total...
  • Page 115 Appendix Table A-10 Medical Condition Analysis: Miscellaneous Disease Miscellaneous Patient Reason For Hospitalization Condition Frequency Blood Transfusion Hospitalization by Intensivist (Disease Status Not Given) Hospitalization for Internal Medicine (other reasons) Hospitalization for Internal Medicine (other surgical reasons) Nausea/Vomiting Observation: Pediatrics Total...
  • Page 116 Appendix Table A-11 Medical Condition Analysis: Neuro-Trauma Disease Neuro –Trauma Patient Reason For Hospitalization Condition Frequency Acute Brain Injury (Aneurysm) Acute Brain Injury (Hematoma-Drilling) Brain Hemorrhage Brain Trauma Chronic Subdural Hematoma Fractured Vertebrae Neuro-trauma Seizure Stroke Subarachnoidal Hemorrhage Subdural Hematoma Total...
  • Page 117 Appendix Table A-12 Medical Condition Analysis: Neurological Disease Neurological Patient Reason For Hospitalization Condition Frequency Altered consciousness Confusion Hypercapnic encephalopathy Muscular dystrophy (Pompe disease) Myopathy ( Pompe disease) Observation: Neurological Observation: Psychiatrics Sacral meningocele dural fistula Tetraplegia ankylosing spondylitis Total...
  • Page 118 Appendix Table A-13 Medical Condition Analysis: Obstetrics / Gynecological OBGYN Patient Reason For Hospitalization Condition Frequency Cesarean Section Dilatation & Curettage Gemellary Pregnancy Gemellary Pregnancy Delivery Observation: Primary Cesarean Section Obstetric Hemorrhage Atonic Uterus Obstetrics (pre-term labor) Ovarian Hyperstimulation syndrome Postpartum Hemorrhage Placental Retention Pre Eclampsia Pregnancy Associated Vomiting...
  • Page 119 Appendix Table A-14 Medical Condition Analysis: Oncology Disease Oncology Patient Reason For Hospitalization Condition Frequency Acute Lymphocytic Leukemia w/ Tumor Lysis Syndrome 2 Acute Myeloid Leukemia AIDS Cerebral Lymphoma Ampullary Adenocarcinoma Ampullary Tubular Pancreatic Adenoma Bile Duct and Gallbladder Adenocarcinoma Bladder Cancer Brain Metastasis Brain Metastasis from Mammary Cancer...
  • Page 120 Appendix Cholangiocarcinoma Chronic Lymphocytic Leukemia Chronic Lymphoid Leukemia CMML Type 2 Colorectal Cncer Distal Esophageal Adenocarcinoma Laryngeal Cancer Lung Cancer w/pleural Lung Carcinoma Mantle Cell Lymphoma Meningioma Metastatic NSCLC Mucinous Adenocarcinoma Multiple Myeloma Neuroendocrine (Pancreas) Obstructive Laryngeal Cancer...
  • Page 121 Appendix Esophageal Leiomyoma Ovarian Cancer Pancreatic Cancer Pancreatic Ductal Adenocarcinoma Peritoneal Carcinomatosis Thyroid Cancer Prostate Stromal Sarcoma Pulmonary Cancer Pulmonary Metastasis from Colic Adenocarcinoma Rectal Cancer Relapsed T-Cell Prolymphocytic Leukemia Small Cell Lung Carcinoma T Cell Lymphoma Brain Tumor Resection Total...
  • Page 122 Appendix Table A-15 Medical Condition Analysis: Oncology Surgical Disease Oncology – Surgical Patient Reason For Hospitalization Condition Frequency Cerebral Metastasis Resection Colon Cancer Surgery Gastrectomy for Gastric Cancer Glossectomy for Cancer Lipoma Surgical Removal Neoplastic Colonic Obstruction Pulmonary Bilobectomy for Lung Cancer Lung Lobectomy Pneumonectomy for Cancer Supra Cellar Meningioma Surgery...
  • Page 123 Appendix Table A-16 Medical Condition Analysis: Pulmonary Disease Pulmonary Patient Reason For Hospitalization Condition Frequency Acute Lung Edema ARDS Asthmatic Crisis Hemoptysis COPD Exacerbation Dyspnea (Respiratory Distress) Hyperventilation Idiopathic Pulmonary Fibrosis Observation: Pulmonologist Pneumocystis Jiroveci Pneumonia...
  • Page 124 Appendix Pneumonia Pneumothorax Pseudomonas Aeruginosa Bilateral Pneumonia Pulmonary Embolism Pulmonary Hypertension Respiratory Failure Total...
  • Page 125 Appendix Table A-17 Medical Condition Analysis: Renal Disease Renal Patient Reason For Hospitalization Condition Frequency Acute Chronic Renal Failure Chronic Kidney Disease End Stage Renal Disease Hematuria Renal Failure Renal Insufficiency Total...
  • Page 126 Appendix Table A-18 Medical Condition Analysis: Sepsis and Infection Sepsis And Infection Patient Reason For Hospitalization Condition Frequency AIDS Cirrhosis Erysipelas (Acute Infection) Fever E.C.I. General Malaise Hemorrhagic shock Liver Cirrhosis Meningitis Meningoencephalitis Osteitis...
  • Page 127 Appendix Sepsis Sepsis (Urological Origin) Septicemia Severe Malaria ( falciparum ) Toxic Coma Tuberculous Meningitis Tuberculous Pneumonia Urinary Tract Infection Urological Catheter and AWES Urosepsis Variceal Bleeding Cirrhosis Wound Infection Total...
  • Page 128 Appendix Table A-19 Medical Condition Analysis: Suicide Patient Reason For Hospitalization Condition Frequency Suicide Table A-20 Medical Condition Analysis: Surgical General Surgical - Patient Reason For Hospitalization Condition Frequency Acoustic Schwannoma Resection Bariatric Surgery BMI Cervical Schwannoma Decortication Surgery Hip Dislocation Hip Replacement Morbid Obesity...
  • Page 129 Appendix Nephrectomy Transabdominal Observation: Surgery Percutaneous Endoscopic Gastronomy Catheter Placement Abdominal Surgery Craniotomy Pharyngolaryngectomy Lung Surgery Pulmonary Nodule Resection Meningeal Leak Closure Pontocerebellar Arachnoidal Cyst Removal Subdural Hematoma Surgical Removal of Schwannoma of the VIII Postoperative Gastric By-Pass for Obesity Peritonitis Multinodulary Thyroid Goiter Kidney Transplant Total...
  • Page 130 Appendix Table A-21 Medical Condition Analysis: Trauma Trauma - Patient Reason For Hospitalization Condition Frequency Abdominal Stab Wound Carbamazepine Overdose Coma Drug Overdose Drug Overdose Coma Femoral Fracture Head Trauma Leg Trauma Methadone Alcohol Overdose Multiple Trauma...
  • Page 131 Appendix Observation (Emergency) Pelvic Fracture Polytrauma Thoracic Trauma Trauma Traumatic Coma Total...

  • Page 132: Parent Drug Class Summary Tables

    Appendix Parent Drug Class Summary Tables The following is a frequency distribution breakdown of the parent drug classes based upon the U.S. Pharmacopia included in the clinical study sites: Table A-22 Parent Drug Class Analysis: Alcohol Alcohol Parent Drug Class Frequency Subclass Analysis Alcohol...
  • Page 133 Appendix Table A-23 Parent Drug Class Analysis: Anti-Infectives Anti-Infective Parent Drug Class Frequency Subclass Analysis Quinolones Anthelminthics Antibiotic Anti-fungal Anti-malarial Anti-tuberculosis Anti-Viral Anti-Viral Protease Inhibitors...
  • Page 134 Appendix Table A-24 Parent Drug Class Analysis: Antidotes Antidote Parent Drug Class Frequency Subclass Analysis Antidote Table A-25 Parent Drug Class Analysis: Anti-Neoplastics Anti-Neoplastic Parent Drug Class Frequency Subclass Analysis Alkylating Agent Anti-Metabolites Monoclonal Antibodies VEGF Inhibitors...
  • Page 135 Appendix Table A-26 Parent Drug Class Analysis: Anti-Psoriatics Anti-Psoriatics Parent Drug Class Frequency Subclass Analysis Vitamin A Retinoid Table A-27 Parent Drug Class Analysis: Anti-Rheumatics Disease Modifying Anti-Rheumatic Parent Frequency Drug Class Subclass Analysis Anti-Rheumatic...
  • Page 136 Appendix Table A-28 Parent Drug Class Analysis: Anti-Vertigo Anti-Vertigo Parent Drug Class Frequency Subclass Analysis Anti-Vertigo Table A-29 Parent Drug Class Analysis: Biologicals Biologicals Parent Drug Class Frequency Subclass Analysis Recombinant Human Erythropoietins...
  • Page 137 Appendix Table A-30 Parent Drug Class Analysis: Blood Products Blood Products Parent Drug Class Frequency Subclass Analysis Plasma Platelets RBCs Table A-31 Parent Drug Class Analysis: Calcimimetic Calcimimetic Parent Drug Class Frequency Subclass Analysis Calcium Receptor...
  • Page 138 Appendix Table A-32 Parent Drug Class Analysis: Cardiovascular Agents Cardiovascular Agents Parent Drug Class Frequency Subclass Analysis ACE Inhibitor / Diuretic ACE Inhibitors Alpha-adrenergic Blockers Angiotensin II Inhibitors Antiadrenergic Antidysrhythmic Antihypertensive Beta Blocker Calcium Channel Blocker...
  • Page 139 Appendix Diuretic Inotropes Vasodilator Vasopressors Vasopressors or Inotropics Table A-33 Parent Drug Class Analysis: Central Nervous System Cholinergic Muscle Stimulant Parent Drug Frequency Class Subclass Analysis Choline Thick Stimulant...
  • Page 140 Appendix Table A-34 Parent Drug Class Analysis: Central Nervous System Central Nervous System Agent Parent Drug Frequency Class Subclass Analysis 5HT3 Antagonist Antiemetic Anaesthetic Analgesic - NSAID Analgesics - narcotic Anticholinergic Anticonvulsant Antiemetic Anti-Parkinson Benzodiazepines Muscle Relaxer Sedative Stimulants...
  • Page 141 Appendix Table A-35 Parent Drug Class Analysis: Coagulation Modifiers Coagulation Modifiers Parent Drug Class Frequency Subclass Analysis Anticoagulants Anti-Platelet Thrombolytics Table A-36 Parent Drug Class Analysis: Contrast Agents Radiologic Agent Parent Drug Class Frequency Subclass Analysis Contrast Agents...
  • Page 142 Appendix Table A-37 Parent Drug Class Analysis: Gastrointestinal Gastrointestinal agent Parent Drug Class Frequency Subclass Analysis Antacid Antacid and Electrolyte Antidiarrheals Antispasmodic Digestive enzymes Gallstone Solubilizing Agents Gastrointestinal Deamination GI Stimulant (also used as antiemetic) H-2 Antagonist...
  • Page 143 Appendix Laxative Laxative / Antacid Protectant Proton-pump Inhibitor Table A-38 Parent Drug Class Analysis: Genitourinary Genitourinary Tract Agent Parent Drug Class Frequency Subclass Analysis Antispasmodic PDE5 Inhibitor...
  • Page 144 Appendix Table A-39 Parent Drug Class Analysis: Hemodialysis Hemodialysis Parent Drug Class Frequency Subclass Analysis Hemodialysis Table A-40 Parent Drug Class Analysis: Hormonal Agents Hormonal Agents Parent Drug Class Frequency Subclass Analysis Glucocorticoids Hormone - Sex Hormone Hormone - Growth...
  • Page 145 Appendix Hormone - Peptide Hormone - Pituitary Hormone - Polypeptide Hormone - Thyroid Hormone- Antidiuretic Insulin – Injectable and Oral Somatostatine Analog Table A-41 Parent Drug Class Analysis: Hyperkalemia Hyperkalemia Agent Parent Drug Class Frequency Subclass Analysis Uncategorized Agent to treat Hyperkalemia...
  • Page 146 Appendix Table A-42 Parent Drug Class Analysis: Immunologic Agent Immunologic Agent Parent Drug Class Frequency Subclass Analysis Immunoglobulins Immunostimulants Immunostimulants - Vaccine Immunosuppressant Table A-43 Parent Drug Class Analysis: Metabolic / Nutritional Metabolic / Nutritional Parent Drug Class Frequency Subclass Analysis Glucose Elevating / Electrolyte...
  • Page 147 Appendix Table A-44 Parent Drug Class Analysis: Metabolic Metabolic agent Parent Drug Class Frequency Subclass Analysis Anti-diabetic Anti-hyperlipidemic Anti-hyperuricemic Bisphosphonates Glucose Elevating Agent Statin...
  • Page 148 Appendix Table A-45 Parent Drug Class Analysis: Nutritional Nutritional Product Parent Drug Class Frequency Subclass Analysis Amino Acid Electrolyte Herbal Supplement Iron Mineral / Electrolyte Multivitamin Vitamin Vitamin / Mineral Vitamin B...
  • Page 149 Appendix Vitamin B-12 Vitamin B-6 Vitamin C Vitamin D Table A-46 Parent Drug Class Analysis: Phosphate Binder Phosphate Binder Parent Drug Class Frequency Subclass Analysis Phosphate Binder...
  • Page 150 Appendix Table A-47 Parent Drug Class Analysis: Plasma Expanders Plasma Expander Parent Drug Class Frequency Subclass Analysis Blood Products Gelatin Globular proteins Plasma Replacement Starch...
  • Page 151 Appendix Table A-48 Parent Drug Class Analysis: Psychotherapeutic Agent Psychotherapeutic Agent Parent Drug Class Frequency Subclass Analysis Antidelirium Antidepressants Antipsychotic - Atypical Antipsychotic - Non-phenothiazine Antipsychotic - Phenothiazines Bipolar Agent...
  • Page 152 Appendix Table A-49 Parent Drug Class Analysis: Respiratory Agent Respiratory Agent Parent Drug Class Frequency Subclass Analysis Antihistamine Bronchodilator Decongestant Expectorant Leukotriene modifier PDE4 Inhibitors...
  • Page 153 Appendix Table A-50 Parent Drug Class Analysis: Smoking Cessation Smoking Cessation Agent Parent Drug Class Frequency Subclass Analysis Smoking Cessation Agent Table A-51 Parent Drug Class Analysis: Topical Agent Topical Agent Parent Drug Class Frequency Subclass Analysis Anti-hemorrhagic Antimicrobial Irrigation Dental and Oral Agents Dermatological Crèam Dermatological Powder...
  • Page 154 Appendix Emollients Hydrating Eye Ointment Medicated Ointment Medicated Ophthalmic Drops Medicated Ophthalmic Drops and Steroid Nasal Antibiotic Nasal Decongestant Nasal Steroid Ophthalmic Diagnostic Agent Ophthalmic Glaucoma Agent Ophthalmic Medicated Steroid Ophthalmic Preparation Topical Photochemotherapeutics...
  • Page 155 Appendix Table A-52 Parent Drug Class Analysis: Topical Anti-Infective Topical Anti-Infective Parent Drug Class Frequency Subclass Analysis Antibiotic Crème Dermatological Antibacterial...

  • Page 156: Ordering Information

    Ordering Information Supplies and Instructions for Use for the OneTouch StatStrip Xpress Glucose Hospital Meter are available from Lifescan. Please contact your local OneTouch representative for ordering information. Details can be found at www.onetouchstatstrip.com.
  • Page 158 Glucose Hospital Meter LifeScan Europe Division of Cilag GmbH International Gubelstassee 34 6300 Zug, Switzerland Manufactured by: For technical assistance, contact Nova Biomedical Corporation you local customer service 200 Prospect Street representative, please refer to Waltham, MA 02454-9141 www.onetouchstatstrip.com. Country of origin: Taiwan...

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