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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. Based upon clinical chart review,

paired glucose results for each study participant on one

or more drugs within a parent drug class were reviewed.

Frequency distribution tables for each Parent Drug class

are presented in

Medical Condition Analysis Summary

Tables section

A separate analysis was performed on all patient glucose

results <70mg/dL to identify any potential safety issues with

the use of the OneTouch StatStrip system in the hypoglyce-

mic range within the intended use population.

Appendix

Содержание OneTouch SS Xpress

Страница 1: ...Glucose Hospital Meter Instructions for Use Manual...

Страница 2: ......

Страница 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 Th...

Страница 4: ...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 Tes...

Страница 5: ...nce 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 Tab...

Страница 6: ......

Страница 7: ...tic medical device Product fulfills the requirements of Directive 98 79 EC IVDD Caution consult accompanying documents Consult instructions for use Linearity Date of Manufacture Control LEVEL Level Lo...

Страница 8: ...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 Throughout this manual NO...

Страница 9: ...TION Capillary whole blood specimens e g obtained by finger stick should not be used in patients receiving inten sive medical intervention therapy because of the potential for pre analytical collectio...

Страница 10: ...ent 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 mea...

Страница 11: ...c 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 di...

Страница 12: ...hcare 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 pathoge...

Страница 13: ...lancing devices may be used with this system 5 For more information refer to the following refer ences Guideline for Isolation Precautions Preventing Transmission of Infectious Agents in Healthcare Se...

Страница 14: ...erstick Devices on More than One Person Poses Risk for Tranmitting Bloodborne Pathogens Initial Commu nication 2010 http www fda gov Medicaldevices Safety AlertsandNotices ucm224025 html CDC Clinical...

Страница 15: ...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 Place the meter away from he...

Страница 16: ...attery 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...

Страница 17: ...th local regulations for biohazardous waste Chemical and Biological Safety Observe all precautionary information printed on the original solution containers Operate the meter in the appropriate enviro...

Страница 18: ...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...

Страница 19: ...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...

Страница 20: ...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 cally in patients with decrease...

Страница 21: ...ps are stored out side of the storage and handling conditions Altitudes above 4500 meters 15 000 feet above sea level have not been evaluated Specimens Only fresh whole blood or whole blood collected...

Страница 22: ...from the vial only when ready to test Use of the system outside of traditional healthcare settings e g ambulance services is limited to the following ambient temperature range 15 C 40 C 59 F 104 F Out...

Страница 23: ...rmance 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 2 If control solution test is within expected ran...

Страница 24: ...ole 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 a...

Страница 25: ...Glu OneTouch StatStrip Xpress Glucose Hospital Meter LCD Display Left Arrow Button Mode Button Right Arrow Button Glucose Test Strip mg dL mmol L Result in mg dL Result in mmol L Ejector Button Push...

Страница 26: ...est Result mg dL or mmol L Beeper ON Indicator Glucose Test Result AM or PM Indicator Date Day Hour Minute OneTouch StatStrip Xpress Glucose Hospital Meter Testing Screen Memory Note This screen indic...

Страница 27: ...are settings with complex medical conditions and drug regiments up to the following concentration levels Tested Interfering Substances Tested Concentration Level Acetaminophen 20 0 mg dL 1 323 mmol L...

Страница 28: ...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 1000 mg dL 25 86 mmol L Cimetidine 5...

Страница 29: ...l 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 3 mg dL 0 0907 mmol L Galactose D 500 mg dL 27 75 mmol L Galactose 1 Pho...

Страница 30: ...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 0 0299 mmol L Lisinopril 0 5 mg dL 0 0123 mmol L Maltose D 500 mg...

Страница 31: ...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 Olanzapine 0 02 mg dL 0 00064 mmol L Pancuronium bromide 0 4 mg dL 0 00...

Страница 32: ...r chloride level 23 8 mg dL 40 mmol L Sodium Nitroprusside dihydrate 0 05 mg dL 0 0019 mmol L Sorbitol 500 mg dL 27 45 mmol L Sucrose 500 mg dL 14 61 mmol L Sulfamethoxazole 1 5 mg dL 0 059 mmol L Tet...

Страница 33: ...23 5 mg dL 1 4 mmol L Vancomycin hydrochloride hydrate 3 mg dL 0 021 mmol L 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 a...

Страница 34: ...seconds 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 recal...

Страница 35: ...y 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...

Страница 36: ...ient 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 Wake...

Страница 37: ...n 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 Install Replace the battery as follows 1 Remov...

Страница 38: ...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 the...

Страница 39: ...33 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 40: ...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 41: ...35 8 Press the MODE button to accept the displayed Minutes choice Setup...

Страница 42: ...ormat 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 Press the MODE button t...

Страница 43: ...37 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 44: ...38 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 45: ...39 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 46: ...40 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 47: ...41 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 48: ...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 These OneTouch Stat...

Страница 49: ...the OneTouch StatStrip Xpress Glucose Hospital Meter and the OneTouch StatStrip Glu cose Test Strips Ranges for the OneTouch StatStrip Xpress Glucose Meter using other commercially available glucose c...

Страница 50: ...ct ed If there are other indications that the system is not working properly Whenever problems storage operator instrument are identified or anytime there is a concern the accu racy of the meter may h...

Страница 51: ...ntrol Linearity Solution Proficiency Solution and blood samples Testing a Quality Control Solution 1 Insert a test strip into the meter Verify that all segments of the screen display If the display is...

Страница 52: ...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 c...

Страница 53: ...olution 7 Glucose quality control test results are available on screen in 6 seconds 8 There is one long beep when the results are ready There are 3 short beeps if test results are outside the measurem...

Страница 54: ...hat the OneTouch StatStrip Glucose Hospital Test Strips and OneTouch StatStrip Glucose Control Solutions are not past their expiration dates Repeat the test with a new strip If the second test fails i...

Страница 55: ...uctions 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 All parts of the OneTouc...

Страница 56: ...ofessionals should wear a new pair of protec tive gloves before testing each new patient For more information refer to the following references 1 Guideline for Isolation Precautions Preventing Transmi...

Страница 57: ...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 Finger...

Страница 58: ...ted 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 Then a flashing blood drop will disp...

Страница 59: ...hly 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 5 Squeeze the finger to form a drop of blood Wipe...

Страница 60: ...ps 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 Discard the tes...

Страница 61: ...ange of the test strip 9 Remove the test strip and discard into an appropri ate biohazard container 10 When patient testing is completed the OneTouch StatStrip Xpress Glucose Hospital Meter should be...

Страница 62: ...in this manual If result is LO less than the measurement 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...

Страница 63: ...creen dis plays on the mem memory screen If there are tests saved the most recent test is dis played first 3 Press the left arrow button to scroll backward through results Press the right arrow button...

Страница 64: ...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 3 The screen displays the numbe...

Страница 65: ...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 66: ...of blood borne pathogens between patients and healthcare professionals Healthcare professionals and others should follow Good Laboratory Practice guidelines and these important safety instructions He...

Страница 67: ...leaning and disinfection procedure was validated a total of 10 950 times to simulate a 3 year use life of 10 patient tests per day 365 days per year Meter Cleaning and Disinfection Procedure Clean and...

Страница 68: ...proper disinfection it is important to clean the meter Step 1 prior to disinfecting the meter Step 2 1 Clean the Meter Remove a fresh germicidal wipe from the canister Wipe the external surface of the...

Страница 69: ...f 3 times horizon tally followed by 3 times vertically avoiding the electrical connector Gently wipe the surface area of the test strip port making sure that no fluid enters the port 3 Observe surface...

Страница 70: ...put on a fresh set of protective gloves before proceeding to perform testing on the next patient Additional information WARNING Do not allow liquid to enter the strip port con nector or allow pooling...

Страница 71: ...meter Damage may include plastic housing cracks cloudiness or frosting of the LCD display response issues with the display battery compartment fluid leakage or test port damage Signs of meter performa...

Страница 72: ...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 t...

Страница 73: ...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 74: ...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 75: ...est strip is removed Replace the battery Battery Icon Troubleshooting CAUTION Attempts to perform glucose testing with a low battery could result in the software rebooting Upon rebooting the software...

Страница 76: ...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 Error A software error has been det...

Страница 77: ...l 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 A blood glucose result will...

Страница 78: ...m 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 Action Repeat the test wi...

Страница 79: ...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 80: ...d 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 Trouble...

Страница 81: ...75 Appendix Appendix The Appendix includes solution and reagent specifications accuracy and precision and reference information...

Страница 82: ...e 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...

Страница 83: ...rage 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 f...

Страница 84: ...ven here should be used only as a guide Test Value Glucose1 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 1 American Diabetes Association Diagnos...

Страница 85: ...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...

Страница 86: ...ol 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 CV mg dL mmol...

Страница 87: ...s requiring intensive medical intervention A description of the clinical study sites is found below Clinical study Site 1 and Site 2 are part of the largest tertiary hospital system in the Netherlands...

Страница 88: ...heart lung diabetes trauma neurology and gynecological conditions Specimens obtained from the operating rooms include patients undergoing surgery for heart and lung condi tions as well as severe trau...

Страница 89: ...treatment programs high dose Ascorbic Acid over an extended period of treatment Clinical study Site 4 located in Brussels Belgium is one of the leading healthcare providers in Europe It has top ranke...

Страница 90: ...obstetrics pediatric and neonatal facilities The clinical study focused on oncology and renal disease patients and was conducted by POC staff The 73 peripheral arterial and peripheral venous specimens...

Страница 91: ...classes The patient populations investigated represent a highly diverse spectrum of severity of illness acuity The effect of confounding factors such as PO2 ventilation pH hematocrit medications endog...

Страница 92: ...ratory method Hospital Wards Divisions ICU ED OR etc Diagnosis or Medical Condition Reason for Hospital stay Drugs and Other Substances Listing of all drugs and other endogenous substances for patient...

Страница 93: ...s 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 Evaluation and Analysis A nu...

Страница 94: ...ition 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...

Страница 95: ...ased upon clinical chart review paired glucose results for each study participant on one or more drugs within a parent drug class were reviewed Frequency distribution tables for each Parent Drug class...

Страница 96: ...rformed 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...

Страница 97: ...75 mg dL Site Within 5 mg dL Within 10mg dL Within 12mg dL Within 15mg dL Exceeds 15mg dL Site 1 64 82 75 82 78 82 79 82 3 82 78 0 91 5 95 1 96 3 3 7 Site 2 79 93 89 93 91 93 92 93 1 93 84 9 95 7 97...

Страница 98: ...92 Site 5 0 0 0 0 0 0 0 0 0 0 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 Appendix...

Страница 99: ...ithin 20 Exceeds 20 Site 1 362 538 497 538 515 538 523 538 532 538 6 538 67 3 92 4 95 7 97 2 98 9 1 1 Site 2 120 214 195 214 208 214 214 214 214 214 0 214 56 1 91 1 97 2 100 100 0 0 Site 3 83 122 112...

Страница 100: ...94 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 Appendix...

Страница 101: ...5 mg dL Within 10 mg dL Within 12 mg dL Within 15 mg dL Exceeds 15 mg dL Site 1 17 20 20 20 20 20 20 20 0 20 85 0 100 100 100 0 0 Site 2 51 59 57 59 58 59 59 59 0 59 86 4 96 6 98 3 100 0 0 Site 5 0 0...

Страница 102: ...Within 20 Exceeds 20 Site 1 77 112 108 112 111 112 111 112 112 112 0 112 68 8 96 4 99 1 99 1 100 0 0 Site 2 84 127 116 127 123 127 127 127 127 127 0 127 66 1 91 3 96 9 100 100 0 0 Site 5 10 29 22 29 2...

Страница 103: ...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 124 Cardiac Surgi...

Страница 104: ...101 Oncology Surgical 27 Pulmonary 161 Renal 27 Sepsis and Infection 90 Suicide 7 Surgical General 71 Trauma 62 Unknown at time of Patient Test 133 Total 1 814 One patient in the clinical database did...

Страница 105: ...urn Trauma Burn Patient Reason For Hospitalization Condition Frequency 22 TBSA burns 35 27 TBSA burns 6 28 TBSA burns 6 55 TBSA burns 42 56 TBSA electrical and flame burns 24 62 TBSA self inflicted bu...

Страница 106: ...Category Condition Frequency PreandPostSurgical Observation Thoracic Surgery 3 Post thoracic surgery 141 Pre Op Coronary Arterial Angiography 7 Cardiac Medical Acute coronary syndrome 1 Heart failure...

Страница 107: ...Cardiac arrest 5 Cardiogenic shock 2 Cardiomyopathy 1 Chronic heart failure 1 Coronary Angiography 4 Endocarditis 6 Cardiac Gangrene 1 Hypertension 2 Myocardial Infarction Ventricular Fib 1 Resuscita...

Страница 108: ...oracic AorticBypassSurgery 12 Cardio Thoracic Aortic Rupture 4 Femoral Aneurism Rupture 2 Fibrosing Mediastinitis 1 Obstructive Arteriopathy 1 Pacemaker Surgical Implant 47 Percutaneous Transluminal A...

Страница 109: ...al Rupture 7 AVR MVR Aortic Stenosis 4 Aortic Valve Replacement 17 CardioThoracic ArterialValveReplace ment Aorta 11 CardioThoracic AtrialFibrillation Maze MVP 8 Cardio Thoracic AVR MVR 7 Mitral Valve...

Страница 110: ...BG 2 art AVR 16 Cardio Thoracic CABG AVR Maze 4 Cardio Thoracic CABG mpl Maze 9 Cardio Thoracic CABG 3 art grafts incl ven graft 46 CardioThoracic CABGbannedvenous grafts 7 Cardio Thoracic CABG robot...

Страница 111: ...CABG 14 Coronary Artery Disease 6 Total CABG 190 Maze Cardio Thoracic Maze Procedure 5 Total All Categories 670 Table A 8 Medical Condition Analysis Endocrinology Disease Endocrinology Patient Reason...

Страница 112: ...ddison s Disease 6 Anemia 3 Diabetes 1 Diabetes mellitus 3 Diabetes Mellitus Uncontrolled 10 Diabetic ketoacidosis 1 Hyperkalemia 1 Hypocalcemic crisis 1 Hypoxemia 1 Inaugural Diabetes 1 Total 30 Appe...

Страница 113: ...ient Reason For Hospitalization Condition Frequency Acute Chronic Liver Failure 2 Adhesive Bowel Obstruction 2 Bleeding Bulbar Ulcer 4 Bleeding Esophagus 1 Constipation 8 Diaphragmatic Hernia 1 Diarrh...

Страница 114: ...108 Hepatitis 1 Observation Abdominal Discomfort 3 Pancreatitis 10 Peritonitis 7 Small Bowel Obstruction 1 Umbilical Hernia 1 Total 61 Appendix...

Страница 115: ...r Hospitalization Condition Frequency Blood Transfusion 1 Hospitalization by Intensivist Disease Status Not Given 4 Hospitalization for Internal Medicine other reasons 15 Hospitalization for Internal...

Страница 116: ...r Hospitalization Condition Frequency Acute Brain Injury Aneurysm 6 Acute Brain Injury Hematoma Drilling 1 Brain Hemorrhage 36 Brain Trauma 3 Chronic Subdural Hematoma 1 Fractured Vertebrae 1 Neuro tr...

Страница 117: ...talization Condition Frequency Altered consciousness 1 Confusion 1 Hypercapnic encephalopathy 2 Muscular dystrophy Pompe disease 1 Myopathy Pompe disease 1 Observation Neurological 16 Observation Psyc...

Страница 118: ...y Pregnancy 1 Gemellary Pregnancy Delivery 1 Observation Primary Cesarean Section 3 Obstetric Hemorrhage Atonic Uterus 1 Obstetrics pre term labor 17 Ovarian Hyperstimulation syndrome 1 Postpartum Hem...

Страница 119: ...cute Myeloid Leukemia 16 AIDS Cerebral Lymphoma 1 Ampullary Adenocarcinoma 1 Ampullary Tubular Pancreatic Adenoma 1 Bile Duct and Gallbladder Adenocarcinoma 1 Bladder Cancer 3 Brain Metastasis 1 Brain...

Страница 120: ...Type 2 1 Colorectal Cncer 1 Distal Esophageal Adenocarcinoma 3 Laryngeal Cancer 2 Lung Cancer w pleural 1 Lung Carcinoma 4 Mantle Cell Lymphoma 2 Meningioma 1 Metastatic NSCLC 3 Mucinous Adenocarcinom...

Страница 121: ...oma 1 Peritoneal Carcinomatosis 2 Thyroid Cancer 1 Prostate Stromal Sarcoma 1 Pulmonary Cancer 2 Pulmonary Metastasis from Colic Adenocarcinoma 1 Rectal Cancer 3 Relapsed T Cell Prolymphocytic Leukemi...

Страница 122: ...ebral Metastasis Resection 1 Colon Cancer Surgery 11 Gastrectomy for Gastric Cancer 1 Glossectomy for Cancer 1 Lipoma Surgical Removal 1 Neoplastic Colonic Obstruction 1 Pulmonary Bilobectomy for Lung...

Страница 123: ...eason For Hospitalization Condition Frequency Acute Lung Edema 4 ARDS 1 Asthmatic Crisis 2 Hemoptysis 1 COPD Exacerbation 28 Dyspnea Respiratory Distress 32 Hyperventilation 1 Idiopathic Pulmonary Fib...

Страница 124: ...118 Pneumonia 62 Pneumothorax 4 Pseudomonas Aeruginosa Bilateral Pneumonia 1 Pulmonary Embolism 11 Pulmonary Hypertension 2 Respiratory Failure 4 Total 161 Appendix...

Страница 125: ...Analysis Renal Disease Renal Patient Reason For Hospitalization Condition Frequency Acute Chronic Renal Failure 2 Chronic Kidney Disease 6 End Stage Renal Disease 3 Hematuria 10 Renal Failure 1 Renal...

Страница 126: ...ection Sepsis And Infection Patient Reason For Hospitalization Condition Frequency AIDS 10 Cirrhosis 6 Erysipelas Acute Infection 7 Fever E C I 1 General Malaise 3 Hemorrhagic shock 2 Liver Cirrhosis...

Страница 127: ...6 Septicemia 2 Severe Malaria falciparum 1 Toxic Coma 1 Tuberculous Meningitis 2 Tuberculous Pneumonia 1 Urinary Tract Infection 5 Urological Catheter and AWES 1 Urosepsis 2 Variceal Bleeding Cirrhosi...

Страница 128: ...uency Suicide 7 Table A 20 Medical Condition Analysis Surgical General Surgical Patient Reason For Hospitalization Condition Frequency Acoustic Schwannoma Resection 1 Bariatric Surgery BMI 3 Cervical...

Страница 129: ...iotomy 7 Pharyngolaryngectomy 1 Lung Surgery 6 Pulmonary Nodule Resection 1 Meningeal Leak Closure 1 Pontocerebellar Arachnoidal Cyst Removal 1 Subdural Hematoma 1 Surgical Removal of Schwannoma of th...

Страница 130: ...ma Patient Reason For Hospitalization Condition Frequency Abdominal Stab Wound 1 Carbamazepine Overdose 1 Coma 1 Drug Overdose 1 Drug Overdose Coma 1 Femoral Fracture 1 Head Trauma 13 Leg Trauma 1 Met...

Страница 131: ...125 Observation Emergency 1 Pelvic Fracture 1 Polytrauma 5 Thoracic Trauma 1 Trauma 18 Traumatic Coma 1 Total 62 Appendix...

Страница 132: ...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 C...

Страница 133: ...ysis Anti Infectives Anti Infective Parent Drug Class Subclass Analysis Frequency Quinolones 6 Anthelminthics 5 Antibiotic 970 Anti fungal 515 Anti malarial 10 Anti tuberculosis 2 Anti Viral 99 Anti V...

Страница 134: ...arent Drug Class Subclass Analysis Frequency Antidote 32 Table A 25 Parent Drug Class Analysis Anti Neoplastics Anti Neoplastic Parent Drug Class Subclass Analysis Frequency Alkylating Agent 2 Anti Me...

Страница 135: ...riatics Anti Psoriatics Parent Drug Class Subclass Analysis Frequency Vitamin A Retinoid 3 Table A 27 Parent Drug Class Analysis Anti Rheumatics Disease Modifying Anti Rheumatic Parent Drug Class Subc...

Страница 136: ...Anti Vertigo Anti Vertigo Parent Drug Class Subclass Analysis Frequency Anti Vertigo 3 Table A 29 Parent Drug Class Analysis Biologicals Biologicals Parent Drug Class Subclass Analysis Frequency Reco...

Страница 137: ...lood Products Blood Products Parent Drug Class Subclass Analysis Frequency Plasma 11 Platelets 6 RBCs 29 Table A 31 Parent Drug Class Analysis Calcimimetic Calcimimetic Parent Drug Class Subclass Anal...

Страница 138: ...cular Agents Parent Drug Class Subclass Analysis Frequency ACE Inhibitor Diuretic 1 ACE Inhibitors 364 Alpha adrenergic Blockers 21 Angiotensin II Inhibitors 93 Antiadrenergic 197 Antidysrhythmic 380...

Страница 139: ...asodilator 376 Vasopressors 68 Vasopressors or Inotropics 367 Table A 33 Parent Drug Class Analysis Central Nervous System Cholinergic Muscle Stimulant Parent Drug Class Subclass Analysis Frequency Ch...

Страница 140: ...mAgentParentDrug Class Subclass Analysis Frequency 5HT3 Antagonist Antiemetic 185 Anaesthetic 465 Analgesic NSAID 947 Analgesics narcotic 840 Anticholinergic 40 Anticonvulsant 140 Antiemetic 71 Anti P...

Страница 141: ...oagulation Modifiers Parent Drug Class Subclass Analysis Frequency Anticoagulants 957 Anti Platelet 30 Thrombolytics 142 Table A 36 Parent Drug Class Analysis Contrast Agents Radiologic Agent Parent D...

Страница 142: ...gent Parent Drug Class Subclass Analysis Frequency Antacid 91 Antacid and Electrolyte 2 Antidiarrheals 13 Antispasmodic 4 Digestive enzymes 11 Gallstone Solubilizing Agents 12 Gastrointestinal Deamina...

Страница 143: ...xative Antacid 61 Protectant 8 Proton pump Inhibitor 754 Table A 38 Parent Drug Class Analysis Genitourinary GenitourinaryTractAgentParentDrugClass Subclass Analysis Frequency Antispasmodic 15 PDE5 In...

Страница 144: ...odialysis Parent Drug Class Subclass Analysis Frequency Hemodialysis 6 Table A 40 Parent Drug Class Analysis Hormonal Agents Hormonal Agents Parent Drug Class Subclass Analysis Frequency Glucocorticoi...

Страница 145: ...rmone Thyroid 60 Hormone Antidiuretic 71 Insulin Injectable and Oral 705 Somatostatine Analog 15 Table A 41 Parent Drug Class Analysis Hyperkalemia Hyperkalemia Agent Parent Drug Class Subclass Analys...

Страница 146: ...Class Subclass Analysis Frequency Immunoglobulins 3 Immunostimulants 4 Immunostimulants Vaccine 3 Immunosuppressant 32 Table A 43 Parent Drug Class Analysis Metabolic Nutritional Metabolic Nutritiona...

Страница 147: ...Drug Class Analysis Metabolic Metabolic agent Parent Drug Class Subclass Analysis Frequency Anti diabetic 100 Anti hyperlipidemic 16 Anti hyperuricemic 19 Bisphosphonates 55 Glucose Elevating Agent 17...

Страница 148: ...alysis Nutritional Nutritional Product Parent Drug Class Subclass Analysis Frequency Amino Acid 100 Electrolyte 81 Herbal Supplement 7 Iron 52 Mineral Electrolyte 685 Multivitamin 94 Vitamin 15 Vitami...

Страница 149: ...Vitamin B 12 20 Vitamin B 6 2 Vitamin C 113 Vitamin D 38 Table A 46 Parent Drug Class Analysis Phosphate Binder Phosphate Binder Parent Drug Class Subclass Analysis Frequency Phosphate Binder 41 Appen...

Страница 150: ...able A 47 Parent Drug Class Analysis Plasma Expanders Plasma Expander Parent Drug Class Subclass Analysis Frequency Blood Products 36 Gelatin 1 Globular proteins 104 Plasma Replacement 3 Starch 46 App...

Страница 151: ...sychotherapeutic Agent PsychotherapeuticAgentParentDrugClass Subclass Analysis Frequency Antidelirium 12 Antidepressants 79 Antipsychotic Atypical 68 Antipsychotic Non phenothiazine 221 Antipsychotic...

Страница 152: ...Drug Class Analysis Respiratory Agent Respiratory Agent Parent Drug Class Subclass Analysis Frequency Antihistamine 175 Bronchodilator 636 Decongestant 22 Expectorant 12 Leukotriene modifier 1 PDE4 I...

Страница 153: ...ubclass Analysis Frequency Smoking Cessation Agent 45 Table A 51 Parent Drug Class Analysis Topical Agent Topical Agent Parent Drug Class Subclass Analysis Frequency Anti hemorrhagic 54 Antimicrobial...

Страница 154: ...Ophthalmic Drops 40 Medicated Ophthalmic Drops and Steroid 11 Nasal Antibiotic 116 Nasal Decongestant 2 Nasal Steroid 10 Ophthalmic Diagnostic Agent 1 Ophthalmic Glaucoma Agent 20 Ophthalmic Medicated...

Страница 155: ...149 Table A 52 Parent Drug Class Analysis Topical Anti Infective Topical Anti Infective Parent Drug Class Subclass Analysis Frequency Antibiotic Cr me 3 Dermatological Antibacterial 90 Appendix...

Страница 156: ...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...

Страница 157: ......

Страница 158: ...ufactured by Nova Biomedical Corporation 200 Prospect Street Waltham MA 02454 9141 Country of origin Taiwan Copyright 2016 LPN54472A 2016 03 P N 02349101 Glucose Hospital Meter For technical assistanc...

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