NOVA BIOMEDICAL StatStrip 55848 Instructions For Use Manual
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NOVA BIOMEDICAL StatStrip 55848 Instructions For Use Manual

Glucose hospital meter system
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Instructions for
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Glucose Hospital Meter System
StatStrip Glu IFU 1.86 PN55848E EN 510K.indd 1
9/13/18 8:29 AM

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  • Page 1 55848 Only Instructions for Use Manual Glucose Hospital Meter System StatStrip Glu IFU 1.86 PN55848E EN 510K.indd 1 9/13/18 8:29 AM...
  • Page 2 StatStrip Glu IFU 1.86 PN55848E EN 510K.indd 2 9/13/18 8:29 AM...
  • Page 3 NOVA BIOMEDICAL SYMBOL DIRECTORY In vitro diagnostic medical device Batch code Product fulfills the requirements of Directive Serial Number 98/79 EC (IVDD) Caution, consult accompanying documents Temperature limitation Consult instructions for use Upper Limit of Temperature Biological risk Number of Tests...
  • Page 4 StatStrip Glu IFU 1.86 PN55848E EN 510K.indd 4 9/13/18 8:29 AM...
  • Page 5 Glucose Meter Instructions for Use Manual Ordering Information ® The StatStrip Glucose Hospital Meter Instructions for Use Manual can be ordered from Nova Biomedical Order Ser- vices. Write or call: Nova Biomedical Corporation Telephone: 1-800-458-5813 200 Prospect Street FAX: 1-781-893-6998 Waltham, MA 02453 (in the U.S.A.)
  • Page 6 U.S.A.: 1-800-545-NOVA 1-781-894-0800 FAX: 1-781-894-0585 For technical assistance outside the United States, call your local Nova subsidiary or authorized distributor. Nova Biomedical GmbH Nova Biomedical Canada Ltd. Hessenring 13a 17 - 2900 Argentia Road Gebäudeteil G Mississauga, Ontario L5N 7X9 D 64546 Mörfelden-Walldorf...

  • Page 7: Table Of Contents

    Table of Contents Instructions for Use Manual Contents Introduction 1.1 About This Manual ...........1-2 1.2 Important Safety Instructions ........1-2 1.3 Intended Use ............1-5 1.4 Capillary Precautions ..........1-6 1.5 Limitations ..............1-6 1.6 General Precautions ..........1-7 1.7 The Sample .............1-7 1.8 Interfering Substances ..........1-8 1.9 Operation Overview ..........1-11 1.9.1 Using the Display Keypad ......1-13 1.9.2 Soft Buttons ..........1-14...
  • Page 8 Table of Contents StatStrip Glucose Hospital Meter Docking/Charging Station Linearity Test 5.1 Running a Linearity Test ..........5-1 Maintenance 6.1 Charging the Meter ..........6-1 6.2 Changing the Battery ..........6-2 6.3 Cleaning and Disinfecting the Meter ......6-4 Troubleshooting 7.1 Meter Screen Alerts ..........7-1 Appendix A.1 StatStrip Glucose Hospital Meter Specifications ..

  • Page 9: Introduction

    The StatStrip Glucose Hospital Meter is a hand-held, battery- powered, in vitro diagnostic laboratory instrument that works in conjunction with Nova Biomedical glucose electrochemical test strips to measure glucose in a whole blood sample, a Quality Control (QC) solution, linearity, or proficiency solutions. In ad- dition to measuring glucose, the meter stores patient test data, StatStrip Glu IFU 1.86 PN55848E EN 510K.indd 1...

  • Page 10: About This Manual

    1.1 About This Manual This manual is for the StatStrip Glucose Hospital Meter System from Nova Biomedical. Throughout this manual, NOTE: indicates especially important information, CAUTION: indicates information that is critical to avoid instrument damage or incorrect results, and WARNING: indicates possible hazard to the operator.
  • Page 11 Instructions for Use Manual 1 Introduction 4. Only auto-disabling, single-use lancing devices may be used with this system. 5. For more information, refer to the following references: "Guidleine for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings 2007," http://www.cdc.gov/hicpac/2007ip /2007isolationprecautons.html.
  • Page 12 StatStrip Glucose Hospital Meter 7. The meter should be serviced by qualified service personnel. Electrical Safety 1. Battery powered: 3.7 V Li Polymer battery (recharge- able/replaceable) 2. Desk-mount Charging Station 3. An LED indicator light to show the battery is charg- ing: yellow indicates charging and green indicates fully charged.

  • Page 13: Intended Use

    Instructions for Use Manual 1 Introduction 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 1. Observe all precautionary information printed on the original solution containers.

  • Page 14: Capillary Precautions

    StatStrip Glucose Hospital Meter It is not intended for use with neonate cord blood specimens. It is not intended for the screening or diagnosis of diabetes mellitus but is indicated for use in determining dysglycemia. 1.4 Capillary Precautions • Caution should be exercised when testing capillary whole blood due to potential pre-analytical variability in capillary specimen collection.

  • Page 15: General Precautions

    Instructions for Use Manual 1 Introduction • Fluoride, EDTA, Sodium, and Ammonium blood collection devices should not be used for arterial and venous specimens. 1.6 General Precautions • Prior to use, read the Instructions for Use Manual. • DO NOT reuse test strips. Test strips should be disposed after a single use.

  • Page 16: Interfering Substances

    StatStrip Glucose Hospital Meter 1.8 Interfering Substances Glucose Interferences: The StatStrip Glucose Hospital Meter System 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...
  • Page 17 Instructions for Use Manual 1 Introduction Tested Tested Interfering Substances Concentration Level 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-Phosphate 500 mg/dL 19.22 mmol/L Gentamicin sulfate 12 mg/dL 0.2513 mmol/L Glycerol...
  • Page 18 StatStrip Glucose Hospital Meter Tested Tested Interfering Substances Concentration Level Ranitidine hydrochloride 1 mg/dL 0.032 mmol/L Salicylate 120.0 mg/dL 7.50 mmol/L Sodium Chloride Deviation from a normal sodium 234 mg/dL 40 mmol/L or chloride level Sodium Nitroprusside dihydrate 0.05 mg/dL 0.0019 mmol/L Sorbitol 500 mg/dL...

  • Page 19: Operation Overview

    Instructions for Use Manual 1 Introduction 1.9 Operation Overview The meter uses a touch screen for menu navigation and data entry. An on-screen keypad allows manual data entry of alphanumeric characters. Laser Barcode Scanner Touch Screen Title Screen Enter Patient ID Patient Result Op: **** Name: A Unit-1...
  • Page 20 StatStrip Glucose Hospital Meter WARNING: Do not stare into the Laser light or point it towards anyone's eyes while scanning a bar- code. NOTE: The Meter is designed such that the Operator uses his or her finger when dealing with the touch screen. A PDA-style pen may be used as a replacement for finger input.

  • Page 21: Using The Display Keypad

    Instructions for Use Manual 1 Introduction 1.9.1 Using the Display Keypad The Display Keypad has 2 formats: numeric and alphanu- meric. To display the alphanumeric keypad from the numeric display, press the 'ABC...' key. To display the numerical display from the alphanumeric display, press the '0..9' key. Title Bar Enter Operator ID Enter Operator ID...

  • Page 22: Soft Buttons

    StatStrip Glucose Hospital Meter 1.9.2 Soft Buttons On-screen buttons, called "Soft Buttons," are used for menu navigation and screen menu choice. Soft Keyboard The soft keyboard functions in the following manner: • An “ABC” soft key turns Alpha Mode ON (letters A-Z, space, +-.!,) to allow alphabetical character input to be inserted.

  • Page 23: Meter Sleep/Wake Up

    Instructions for Use Manual 1 Introduction 1.9.3 Meter Sleep/Wake Up The LCD display is turned off to conserve battery power (sleep mode) after an Operator defined time of no activity. Keep-awake activities include: • Touching the screen • Placing the meter into the Charging Station • Inserting a test strip If the meter is placed into the docking station, the following conditions should be expected: •...

  • Page 24: Result Alerts

    StatStrip Glucose Hospital Meter 1.9.4 Result Alerts The result is displayed differently depending on whether it is in or out of the normal range for glucose measurement. • Results within the normal range are displayed in Blue. • Results outside the normal range are displayed in Red.

  • Page 25: Multi-Screen Menus

    Instructions for Use Manual 1 Introduction 1.9.5 Multi-screen Menus When a menu or a list is too large to be fully displayed on the LCD screen, or a menu item is one of many in a list, a Page Up (lower left side) and a Page Down (lower right side) soft keys display to navigate forward and backward amongst the screens.

  • Page 26: Power Up Procedure

    StatStrip Glucose Hospital Meter 1.10.1 Power Up Procedure After initial power up or after battery replacement, the Boot screen appears and is displayed while the software loads. Once the software has loaded, the Welcome screen is displayed. Figure 1.4 Boot Screen Operator ID displays here Meter's name...

  • Page 27: Operator Login

    Instructions for Use Manual 1 Introduction Messages or Alerts on the Home screen • Press OK to begin testing • Memory Full Dock Meter Immediately • Battery Low Charge/Replace Battery • QC Due: xx:xx hrs. • Download Due: xx:xx hrs •...
  • Page 28 StatStrip Glucose Hospital Meter NOTE: When an invalid ID is entered, the screen displays the invalid ID number with a message "is not a valid ID Try again." 3. Press the Accept soft key at the bottom of the screen.. Enter Operator ID Enter Operator ID Name: A Unit-1...

  • Page 29: Administration (Admin) Screen

    Instructions for Use Manual 1 Introduction 1.12 Administration (Admin) Screen This screen has soft keys to perform a number of non- patient functions: give the meter a name, set the time and date, reset the facility, etc. From the Patient Test screen, press the Menu soft key then the Admin soft key: the Admin screen displays.

  • Page 30: Naming The Meter

    StatStrip Glucose Hospital Meter 1.12.1 Naming the Meter The meter can be given a name with respect to where it will be used: i.e., Your Location. 1. From the Patient Test screen, press the Menu then the Admin soft button. 2.

  • Page 31: Sound On/Off

    Instructions for Use Manual 1 Introduction Set Date/Time Op: **** Set Date/Time Op: **** Name: A Unit-1 13:42 13:42 Name: A Unit-1 Current Time: Current Time: : 42 : 45 Current Date: Current Date: Accept Soft yyyy yyyy 2006 2006 Accept Back Accept...

  • Page 32: Unarchive

    StatStrip Glucose Hospital Meter 1.12.5 Unarchive Once the data are transferred to the host computer, the data become archived and cannot be transferred again. If there is a need to retransfer data because it did not transfer or was lost on the host computer, the data must first be unarchived. Performing this task unarchives all data.

  • Page 33: Assign Location

    Instructions for Use Manual 1 Introduction 1.13 Assign Location The Location can be assigned or changed. If there is no location assigned, the screen displays Unassigned. 1. To assign or change a location, first log on the meter. 2. Press the Menu then the Assign Location button and select a location from the displayed list. 3.
  • Page 34 StatStrip Glucose Hospital Meter 1-26 StatStrip Glu IFU 1.86 PN55848E EN 510K.indd 26 9/13/18 8:29 AM...

  • Page 35: Quality Control

    External controls materials are available from Nova Biomedical for verifying the integrity of the StatStrip Glucose Hospital Meter. These StatStrip Glucose Control Solutions consist of 3 levels of ready-to- use liquid controls.

  • Page 36: Quality Control Test

    StatStrip Glucose Hospital Meter • Whenever problems (storage, operator, instrument) are identified or anytime there is a concern the accuracy of the meter may have been affected by rough handling (such as dropping the meter). • As required by the institution’s quality control policy or local regulatory requirements Good Laboratory Practice principles suggest that external controls must be run whenever the laboratory director has any...
  • Page 37 Instructions for Use Manual 2 QC 4. The Enter QC Lot screen displays. Enter the QC lot number, select from the QC Lot List screen (press the List soft button), or scan the barcode. To scan the barcode, press the Scan soft key. NOTE: If the QC Lot Number is invalid, the screen displays the invalid number with "is not a valid QC Lot Try again."...
  • Page 38 StatStrip Glucose Hospital Meter 7. With the test strip correctly inserted, the Apply Sample screen displays. 8. Gently mix the StatStrip Glucose Control Solution before each use. 9. Discard the first drop of control solution from the bottle to avoid contamination. 10. Place a drop of control solution from the bottle at the end of the test strip until the solution is drawn into the well of the test strip.
  • Page 39 Repeat the test with a new strip. If the second test fails, inspect and clean the meter according to Section 6.3, Cleaning the Meter. If the third test fails, contact Nova Biomedical Technical Support toll free at 1-800-545-NOVA. StatStrip Glu IFU 1.86 PN55848E EN 510K.indd 5...

  • Page 40: Add Comment To A Result (Patient, Qc, Linearity)

    StatStrip Glucose Hospital Meter 2.4 Add Comment to a Result (Patient, QC, Linearity) To add a comment to a result, press the Comment soft key on the Result screen. The Add Comment screen displays with preformed com- ments. 1. If appropriate, select one of the comments from the comments list on the Add Comment screen.

  • Page 41: Patient Samples

    Instructions for Use Manual 3 Patient Samples 3 Patient Samples This section describes how to perform tests with the StatStrip Glucose Hospital Meter System. 3.1 Important Safety Instructions Standard Precautions should be adhered to when handling or using the StatStrip Glucose Hospital Meter System to reduce the risk of disease transmission.

  • Page 42: Running A Patient Sample

    StatStrip Glucose Hospital Meter http://www.fda.gov/Medicaldevices/Safety/AlertsandNo- tices/ucm224025.html. 4. "CDC Clinical Reminder: Use of Fingerstick Devices on More than One Person Poses Risk for Transmitting Bloodborne Pathogens." (2010) http://www.cdc.gov/ injectionsafety/Fingerstick-DevicesBGM.html. 3.2 Running a Patient Sample The meter shows graphically a step-by-step procedure to run a glucose test.
  • Page 43 Instructions for Use Manual 3 Patient Samples Data Entry Enter Strip Lot Op: **** Enter Strip Lot Op: **** Field Name: A Unit-1 13:42 13:42 Name: A Unit-1 _________________________ 0206506089 _________________________ Accept Soft Key Scan Erase Scan Soft Key Accept Clear Back Scan...
  • Page 44 StatStrip Glucose Hospital Meter 8. From the Enter Patient ID screen, enter the Patient ID: from Patient ID List screen (press List soft key), by pressing numeric/alphanumeric soft keys (press the ABC... soft key), or scanning the barcode ID. 9. From the Enter Accn Num screen, enter the Acces- sion Number: by pressing numeric/alphanumeric soft keys (press the ABC...
  • Page 45 Instructions for Use Manual 3 Patient Samples 11. The Insert Strip screen displays. Insert a test strip as shown on the meter screen. Insert Strip Insert Strip Op: 8636 Op: **** Meter Name: NICU-1 Name: A Unit-1 13:42 13:42 Insert Test Strip in meter Insert Test Strip in meter Cancel Cancel...
  • Page 46 StatStrip Glucose Hospital Meter 14. Use the Safety Lancet to puncture the finger. 15. Squeeze the finger to form a drop of blood. Wipe away the first drop of blood then squeeze the finger again to form a second drop of blood. Figure 3.6 Squeeze the Finger to Form a Drop of Blood 16. The Apply Sample screen should be displaying. When the blood drop appears, touch the end of the test strip to the blood drop until the well of the test strip is full and the meter beeps.
  • Page 47 Instructions for Use Manual 3 Patient Samples 17. The test results will appear in 6 seconds. NOTE: Do not remove the test strip while the countdown is in progress. 18. Remove the strip manually or use the ejector button on the back of the meter to eject the strip directly into a biohazard container.

  • Page 48: Review Results

    StatStrip Glucose Hospital Meter 3.3 Review Results All results can be recalled and reviewed: Patient Results, QC Results, and Linearity Results. The Review Results screen can be sorted by ID, Time/Date, or Type. 1. From the Patient Test screen, press the Review soft key.
  • Page 49 Instructions for Use Manual 3 Patient Samples 5. Press the Page Down or Page Up soft key to scroll through the stored results. Press the View soft key to view the selected result. Press the Previous soft key to view the previous result.
  • Page 50 StatStrip Glucose Hospital Meter 3-10 StatStrip Glu IFU 1.86 PN55848E EN 510K.indd 10 9/13/18 8:29 AM...

  • Page 51: Docking/Charging Station

    Instructions for Use Manual 4 Docking/Charging Station 4 Docking/Charging Station When the meter is not in use, place it into the Docking/ Charging Station. This will enable the meter to stay fully charged. The Docking/Charging Station is connected to a power source and to the computer network as follows: 1. Plug the fixed power cord from the power supply into the back of the Charging Station.
  • Page 52 StatStrip Glucose Hospital Meter 4. Connect the Docking/Charging Station to the net- work through the Ethernet connection at the back of the station. The connection is marked with the Ethernet symbol. • The green left light is on if the station is con- nected to the network.

  • Page 53: Linearity Test

    Instructions for Use Manual 5 Linearity Test 5 Linearity Test This section describes how to perform Linearity tests with the StatStrip Glucose Hospital Meter. There are 5 levels in the StatStrip Glucose Linearity kit. Refer to the StatStrip Linearity Kit package insert sheet for complete instructions, indications, pre- cautions, and limitations of the system.
  • Page 54 StatStrip Glucose Hospital Meter 5. The Enter Linearity Lot screen displays. Enter the Linearity lot number, select from the Linearity Lot List screen (press the List soft button), or scan the barcode. To scan the barcode, press the Scan soft key.
  • Page 55 Instructions for Use Manual 5 Linearity Test 8. With the test strip correctly inserted, the Apply Sample screen displays. 9. Gently mix the StatStrip Linearity Solution before each use. 10. Discard the first drop of linearity solution from the bottle to avoid contamination. 11. Place a drop of linearity solution from the bottle at the end of the test strip until the solution is drawn into the well of the test strip.
  • Page 56 StatStrip Glucose Hospital Meter 12. Recap the linearity solution. The Testing Sample screen displays. The screen shows a clock with seconds remaining below the clock. 13. When the meter completes the test, the Linearity Result screen displays with the results in mg/dL or mmol/L.

  • Page 57: Maintenance

    Instructions for Use Manual 6 Maintenance 6 Maintenance The meter is very low maintenance. The meter needs to have the battery charged in the Charging Station, battery replaced, or its surface cleaned/disinfected. 6.1 Charging the Meter When the Battery LOW symbol displays on the screen, place the meter into the Charging Station.

  • Page 58: Changing The Battery

    If you have a spare fully charged battery, it can be changed to allow for continuous operation. WARNING: Replace the battery with Nova Biomedical Part Numbers 46827 or 50436 only. Using another battery may present a risk of fire or explosion. If discarding, dispose of the battery promptly.
  • Page 59 Instructions for Use Manual 6 Maintenance 3. Push up on the battery latch. Remove the drained battery. Figure 6.4 Removing the Battery 4. Replace with a fully charged battery. NOTE: The battery is keyed to allow only insertion from bottom first then push in top.

  • Page 60: Cleaning And Disinfecting The Meter

    Acceptable Cleaning and Disinfecting Materials Nova Biomedical 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.
  • Page 61 Instructions for Use Manual 6 Maintenance 1. Clean the Meter. • Remove a fresh germicidal wipe from the canister. • Wipe the external surface of the meter thoroughly with a fresh germicidal disinfecting bleach wipe. Discard the used wipe into an appropriate biohazard container.
  • Page 62 StatStrip Glucose Hospital Meter 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. Figure 6.9 Wash and Sanitize Hands Additional information WARNING: Do not allow liquid to enter the strip port connector or allow pooling of liquid on the touch screen.

  • Page 63: Troubleshooting

    Instructions for Use Manual 7 Troubleshooting 7 Troubleshooting 7.1 Meter Screen Alerts The meter displays a number of alerts: 1. Battery Low - Change the battery or place the meter onto the Charging/Docking Station. Welcome 13:42 Name: Meter Meter Your Facility Facility: Your Location Location:...
  • Page 64 StatStrip Glucose Hospital Meter 3. Temperature - Meter will only work within the tem- perature range of 59°F to 104°F (15°C to 40°C). Return the meter to an environment within the specified temperature range of 59°F to 104°F (15°C to 40°C). Analysis Error Op: **** Name: A Unit-1 13:42 Temperature Error Remove strip to Continue...
  • Page 65 Instructions for Use Manual 7 Troubleshooting 5. Replace Strip - Occurs after insertion of strip or oc- curs during analysis. Insert another strip and retest. If the error code persists, perform the test using an alternate test strip vial or alternate method. Analysis Error Op: **** Name: A Unit-1...
  • Page 66 StatStrip Glucose Hospital Meter 7. Transfer Failed - Server refuses to allow dialog with meter, or Connection to server was broken. Please check the network settings, status of your network, or contact your administrator for assistance. Transfer Failed Transfer Failed Op: **** Op: **** Name: A Unit-1...

  • Page 67: A Appendix

    Instructions for Use Manual Appendix A A Appendix Appendix A includes analyzer specifications, solutions and reagents, consumable lists, reference information, and war- ranty for the StatStrip Glucose Hospital Meter. A.1 StatStrip Glucose Hospital Meter Specifications Measurement Range: Glu 10-600 mg/dL or 0.6-33.3 mmol/L Samples: •Capillary whole blood (finger stick), Acceptable Venous whole blood, arterial whole blood, neonatal heel stick, and neonatal arterial whole bloodsam-...

  • Page 68: Controls/Linearity Solutions

    StatStrip Glucose Hospital Meter Weight: 220 grams (0.49 lb) Power: 3.7V Li Polymer battery (Rechargeable/Replaceable) Environmental: Temperature range 59°F - 104°F (15°C - 40°C) Altitude Up to 15,000 feet (4500 meters) Relative Humidity Up to 90% (noncondensing) Chemistry Measurement The typical imprecision for glucose both for within- run and day-to-day Glucose Levels Glucose Levels...

  • Page 69: Barcode Scanner

    Instructions for Use Manual Appendix A A.3 Barcode Scanner 1. The barcode scanner is a 2-dimensional scanner and is able to interpret the following ID formats a. Code 39 Extended b. Code 93 c. Code 128 d. Interleaved 2 of 5 e.

  • Page 70: Normal Glucose Adult Values Non-Diabetic

    Diabetes: Standards of Medical care in Diabetes. Diabetes Care, Volume 41, Supplement 1, January 2018. A.5 Ordering Information Supplies and parts for the StatStrip Glucose Hospital Meter are available from Nova Biomedical. DESCRIPTION Part # Battery for StatStrip Meter, 4-Pack ......46827 Battery for StatStrip Meter, 5-Pack ......50436...

  • Page 71: Theory

    A.7 Results of Multi-Center Clinical Study: Patients Requiring Intensive Medical Intervention/Therapy Introduction Nova Biomedical conducted a large multi-center study of the StatStrip Glucose Hospital Meter System at five (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.
  • Page 72 StatStrip Glucose Hospital Meter cal 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. Specimens obtained from the operating rooms include patients undergoing surgery for heart and lung conditions as well as severe trauma and neurological conditions.
  • Page 73 Instructions for Use Manual Appendix A were collected from 73 different patients and are from the types of patients that one would see in oncology and renal healthcare settings. StatStrip performance versus the laboratory methods was evaluated by paired specimen analyses (arterial and venous whole blood versus plasma) from patients within various clinical settings.
  • Page 74 Evaluation and Analysis Nova Biomedical applied a number of clinical assessment methods to demonstrate the performance of the StatStrip versus central laboratory reference glucose methods. Each...

  • Page 75: Clinical Study Performance

    Instructions for Use Manual Appendix A A separate analysis was performed on all patient glucose results <70mg/dL to identify any potential safety issues with the use of the StatStrip system in the hypoglycemic range within the intended use population. An analysis was performed to determine whether specimen collection site (central or peripheral) or specimen type (ar- terial or venous) has an impact on the performance of the StatStrip system with the intended use population.
  • Page 76 StatStrip Glucose Hospital Meter Table A-2 Arterial Specimens Analytical and System Accuracy Comparison: Glucose concentrations > 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 (67.3%) (92.4%) (95.7%)
  • Page 77 Instructions for Use Manual Appendix A Table A-4 Venous Specimens Analytical and System Accuracy Comparison: Glucose concentrations > 75 mg/dL Site W i t h i n W i t h i n W i t h i n W i t h i n W i t h i n Exceeds ±...

  • Page 78: Medical Condition Analysis Summary Tables

    StatStrip Glucose Hospital Meter A.7.2 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...
  • Page 79 Instructions for Use Manual Appendix A 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 Table A-7 Medical Condition Analysis: Cardiac Disease Cardiac Patient Reason For Hospitalization Sub Category Condition...
  • Page 80 StatStrip Glucose Hospital Meter Endocarditis Cardiac Gangrene Hypertension Myocardial Infarction/Ventricular-Fib Resuscitation Stable Angina 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...
  • Page 81 Instructions for Use Manual Appendix A 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) Cardio Thoracic (CABG robot ven 3art.
  • Page 82 StatStrip Glucose Hospital Meter 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 Hepatitis Observation: Abdominal Discomfort Pancreatitis...
  • Page 83 Instructions for Use Manual Appendix A 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...
  • Page 84 StatStrip Glucose Hospital Meter 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...
  • Page 85 Instructions for Use Manual Appendix A Central Nervous System Lymphoma Chemotherapy 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 86 StatStrip Glucose Hospital Meter 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...
  • Page 87 Instructions for Use Manual Appendix A 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 Pneumonia Pneumothorax Pseudomonas Aeruginosa Bilateral Pneumonia...
  • Page 88 StatStrip Glucose Hospital Meter 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 Sepsis Sepsis (Urological Origin) Septicemia Severe Malaria ( falciparum ) Toxic Coma...
  • Page 89 Instructions for Use Manual Appendix A 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 Nephrectomy Transabdominal Observation: Surgery Percutaneous Endoscopic Gastronomy Catheter Placement Abdominal Surgery...

  • Page 90: Parent Drug Class Summary Tables

    StatStrip Glucose Hospital Meter 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 Observation (Emergency) Pelvic Fracture Polytrauma...
  • Page 91 Instructions for Use Manual Appendix A 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 Table A-24 Parent Drug Class Analysis: Antidotes Antidote Parent Drug Class Frequency Subclass Analysis Antidote...
  • Page 92 StatStrip Glucose Hospital Meter Table A-27 Parent Drug Class Analysis: Anti-Rheumatics Disease Modifying Anti-Rheumatic Par- Frequency ent Drug Class Subclass Analysis Anti-Rheumatic 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...
  • Page 93 Instructions for Use Manual Appendix A 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 Diuretic Inotropes Vasodilator...
  • Page 94 StatStrip Glucose Hospital Meter Table A-34 Parent Drug Class Analysis: Central Nervous System Central Nervous System Agent Parent Frequency Drug Class Subclass Analysis 5HT3 Antagonist Antiemetic Anaesthetic Analgesic - NSAID Analgesics - narcotic Anticholinergic Anticonvulsant Antiemetic Anti-Parkinson Benzodiazepines Muscle Relaxer Sedative Stimulants Table A-35 Parent Drug Class Analysis: Coagulation Modifiers...
  • Page 95 Instructions for Use Manual Appendix A 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 Laxative Laxative / Antacid...
  • Page 96 StatStrip Glucose Hospital Meter Table A-40 Parent Drug Class Analysis: Hormonal Agents Hormonal Agents Parent Drug Class Frequency Subclass Analysis Glucocorticoids Hormone - Sex Hormone Hormone - Growth Hormone - Peptide Hormone - Pituitary Hormone - Polypeptide Hormone - Thyroid Hormone- Antidiuretic Insulin –...
  • Page 97 Instructions for Use Manual Appendix A Table A-43 Parent Drug Class Analysis: Metabolic / Nutritional Metabolic / Nutritional Parent Drug Class Frequency Subclass Analysis Glucose Elevating / Electrolyte Table A-44 Parent Drug Class Analysis: Metabolic Metabolic agent Parent Drug Class Frequency Subclass Analysis Anti-diabetic...
  • Page 98 StatStrip Glucose Hospital Meter Table A-46 Parent Drug Class Analysis: Phosphate Binder Phosphate Binder Parent Drug Class Frequency Subclass Analysis Phosphate Binder Table A-47 Parent Drug Class Analysis: Plasma Expanders Plasma Expander Parent Drug Class Frequency Subclass Analysis Blood Products Gelatin Globular proteins Plasma Replacement...
  • Page 99 Instructions for Use Manual Appendix A 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 Table A-50 Parent Drug Class Analysis: Smoking Cessation Smoking Cessation Agent Parent Drug Frequency Class Subclass Analysis Smoking Cessation Agent...
  • Page 100 StatStrip Glucose Hospital Meter 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 Emollients Hydrating Eye Ointment Medicated Ointment Medicated Ophthalmic Drops Medicated Ophthalmic Drops and Steroid Nasal Antibiotic Nasal Decongestant...

  • Page 101: Results Of Multi-Center Capillary Critical Care Study

    A.8 Results of Multi-Center Capillary Critical Care Study: Patients Requiring Intensive Medical Intervention/Therapy Introduction Nova Biomedical conducted a large multi-center study of the StatStrip Glucose Hospital Meter at 3 leading medical centers to demonstrate the clinical performance of capillary whole blood specimens obtained by finger stick within critical care hospital settings on patients receiving intensive medi- cal intervention/therapy.

  • Page 102: Real World Evidence Studies

    StatStrip Glucose Hospital Meter Table A-53: Study Site #1 Breakdown Departments Patients Enrolled CVICU MICU Total Patient Enrollment The capillary whole blood glucose results were compared to plasma glucose results obtained from arterial or venous specimens measured on an IDMS traceable Roche Cobas Modular P800 hexokinase method (Roche Diagnostics, Indianapolis, IN).

  • Page 103: Clinical Study Performance

    Instructions for Use Manual Appendix A the capillary test. Medical conditions and medications were unavailable for critical care patients in this study. Clinical Study #3 was a real world clinical review of 14,645 critical care patients throughout all critical care settings that had a glucose test performed using a capillary whole blood specimen obtained by finger stick and a plasma glucose test performed in the central laboratory within 15 minutes of...

  • Page 104: Wireless Meter Use

    StatStrip Glucose Hospital Meter Table A-56 Study #2 and #3 (Retrospective Combined) Fingertip capillary samples with glucose concentrations <75 mg/dL Within Within Within Within Exceeds +5 mg/dL +10 mg/dL +12 mg/dL +15 mg/dL +15 mg/dL 907/1894 1470/1894 1614/1894 1737/1894 157/1894 (47.9%) (77.6%) (85.2%)

  • Page 105: Wireless Network Connections

    • When docked, allows full communication with the device manager. • Is configurable only by: a. A Trained Nova Biomedical Service Represen- tative, or b. An authorized and trained system administrator. • Enabled on the meter by an authorized operator Follow your facility guidelines for using wireless local area network connections.
  • Page 106 But the possibility exists that some industrial and /or medical device high power systems may wipe out any attempted communication use of a WLAN. The recommendation of Nova Biomedical is to perform a site survey and interference analysis by qualified personnel, with the appropriate testing equipment. Search for signals that...
  • Page 107 Instructions for Use Manual Appendix A the FCC authorization to operate this equipment. The StatStrip Glucose Hospital Meter with wireless option complies with Part 15 of the FCC Rules and with RSS-210 of Industry Canada under these 2 conditions. 1. This device may not cause harmful interference. 2.

  • Page 108: Wifi Radio Option Operation

    StatStrip Glucose Hospital Meter with wireless option can only be accomplished through the device manager by a Trained Nova Biomedical Service Representative, or an authorized and trained system administrator. WARNING: If you suspect that the meter’s wireless radio...

  • Page 109: Enabling/Disabling The Wifi Radio

    Instructions for Use Manual Appendix A Radio is ON and connected to the WAP with ap- proximately 1/2 signal strength.. Radio is ON and connected to the WAP with ap- proximately 1/4 signal strength.. Radio is ON with no signal, or no connection to the AP.
  • Page 110 StatStrip Glucose Hospital Meter 6. Press the Factory/Custom button to toggle to Cus- tom. 7. The meter now displays the name of the attached SSID, CA and User certificate names and expiration date. WiFi Setup Op: **** 13:42 Name: A Unit-1 The WiFi Radio is now “ON” and WiFi ON/OFF will start the WAP association.

  • Page 111: Wifi Usage Considerations

    Instructions for Use Manual Appendix A A.9.6 WiFi Usage Considerations The StatStrip Glucose Hospital Meter with wireless option is certified for use on Wireless Local Area Networks (WLANs) using electromagnetic waves in the 2.4 GHz and/or 5 GHz frequency ranges to wirelessly transmit data. The three of the currently recognized IEEE standards for WLANs utilized by the StatStrip Glucose Hospital Meter with wireless option are 802.11a, 802.11b and 802.11g.

  • Page 112: Wifi Technical Considerations

    A.9.7 WiFi Technical Considerations Prior to connecting any StatStrip Glucose Hospital Meter with wireless option to a wireless network, Nova Biomedical recommends that a WLAN site survey be performed. The WLAN site survey •...

  • Page 113: Wifi Function And Performance

    Instructions for Use Manual Appendix A A.9.8 WiFi Function and Performance As described above, the StatStrip Glucose Hospital Meter with wireless option supports the 802.11a, b & g standards. In a typical WLAN environment (correct WLAN administra- tion, “good” signal quality, typical population of other clients present, any of the supported security models enabled, etc), this translates into the following WiFi specific performance: •...
  • Page 114 StatStrip Glucose Hospital Meter • The StatStrip Glucose Hospital Meter with wireless op- tion, with WiFi enabled and connected, will immediately query the device manager if an unknown Operator or Patient ID is entered on the meter during a test proce- dure.

  • Page 115: Meter Wi-Fi Settings, Range, Options

    Instructions for Use Manual Appendix A A.9.9 Meter Wi-Fi Settings, Range, Options Setting Description Range Options On Meter WiFi On/Off Turns the wire- a. On less radio on b. Off or off Factory/Cus- Chooses the a. Factory - Installs radio configu- the factory radio ration set.
  • Page 116 StatStrip Glucose Hospital Meter From Device Manager SSID Defines the 0-32 Charac- a. Enter the name Service Set ters of the SSID of the Identification network to join. (SSID) of the network to join. PASSWORD If required, open a. Enter the pass- defines the word user credential...
  • Page 117 Instructions for Use Manual Appendix A Pac File Name Pac PASSWORD Tx Power Sets the max 1 - 63 mW a. 1 mW transmit output b. 5 mW power c. 10 mW d. 20 mW e. 30 mW f. 50 mW g.
  • Page 118 StatStrip Glucose Hospital Meter Encryption Sets the en- Manual WEP Types cryption type to Auto WEP be used. WPA PSK WPA TKIP WPA2 PSK WPA2 AES CCKM EKIP CKIP Manual CKIP Auto WPA AES WPA2 TKIP EAP Types Sets the au- None thentication to LEAP...

  • Page 119: Warranty

    Appendix A A.10 Warranty Subject to the exclusions and upon the conditions specified below, Nova Biomedical or the authorized Nova Biomedical distributor warrants that he will correct free of all charges including labor, either by repair, or at his election, by replace- ment, any part of an instrument which fails under warranty after delivery to the customer because of defective material or workmanship.
  • Page 120 This warranty is invalid under the following conditions: 1. The date printed on the package label has been exceeded. 2. Non-Nova Biomedical reagents or controls are used, as follows: Nova Biomedical will not be responsible for any warranty on a StatStrip Glucose Hospital...
  • Page 121 StatStrip Glu IFU 1.86 PN55848E EN 510K.indd 55 9/13/18 8:29 AM...
  • Page 122 StatStrip Glu IFU 1.86 PN55848E EN 510K.indd 56 9/13/18 8:29 AM...

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