Performance Characteristics | Arkon PRT03831-xxx specs

Section 18

Appendix B: Specifications

153

18 Appendix B: Specifications (con’t)

Performance Characteristics

Note: Please consult your healthcare team on how to use the information in this section.

Performance of the FreeStyle Navigator® Continuous Glucose Monitoring System was evaluated in a controlled clinical study. The study was conducted in 3 centers and included a total of 58 subjects with diabetes. Each subject wore two FreeStyle Navigator Sensors over a 5-day period. The subjects wore one sensor on the back of the upper arm and one on their abdomen. The FreeStyle Navigator system was calibrated with capillary finger- stick measurements using the built-in FreeStyle Blood Glucose Meter at approximately 10, 12, 24 and 72 hours after insertion of the sensor.All measurements were performed by a trained clinic study staff or the subject.

During the study, subjects came to the clinical center for frequent glucose samples measured once every

15 minutes on the YSI (Yellow Springs Instrument) STAT Plus™ Glucose Analyzer. YSI measurements were performed in duplicate on venous whole blood and the FreeStyle measurements were performed in duplicate on capillary blood from the finger. All YSI whole blood measurements were adjusted by applying a +12% correction factor (based on a normal hematocrit value of 45%).

Users and healthcare providers should consider that performance in this study might be idealized. Participants enrolled in the clinical study and certain conditions of the study tend to result in above average glucose control. This, in turn, may result in the appearance that the FreeStyle Navigator Continuous Glucose Monitoring System agrees with blood glucose levels better than it does under typical conditions. Monitors that measure glucose in interstitial fluid often show better agreement to blood glucose levels when glucose levels are not changing rapidly or when glucose levels are not extremely low or high. The following are some examples of why performance of the FreeStyle Navigator Continuous Glucose Monitoring System may be idealized.

•Subjects saw, on average, 15 fingerstick results per day in the clinic and 8 fingerstick results per day at home. This enables subjects to control their glucose levels better.

•While subjects participated in the clinic portion of the study, they were more limited in their activities than someone at home. They were also provided with all their meals. Subjects who are more active, or with poor eating habits, may create more challenging conditions for the FreeStyle Navigator Continuous Glucose Monitoring System.

•The built-in FreeStyle glucose meters used in the study were well maintained. Because the built-in FreeStyle meter is used to calibrate the FreeStyle Navigator Continuous Glucose Monitoring System, performance may be poorer if the system is not well maintained. It is important to carry out quality-control checks on the system and code the system according to the manufacturer’s instructions to optimize performance of the FreeStyle Navigator Continuous Glucose Monitoring System.

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Arkon PRT03831-xxx manual Performance Characteristics

PRT03831-xxx specifications

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Contents

User’s Guide Page Indications for Use Page Glossary of Symbols How to Use this Guide? Table of Contents Review Reports and Edit Events 124 Enter Glucose Targets Clean Your System 128 Clean Your TransmitterAppendix C FCC Compliance Information Page Getting Acquainted Key Terms Introduction Getting Acquainted How are the parts packaged? Delivery Key features of the System Using your system How do I prepare my system for the first time? Important Things to Remember About System Calibration Important Things to Remember About System Calibration con’t Before You Get Started con’t Helpful health related information Hypoglycemia unawareness can develop for several reasons Symptoms of Hypoglycemia Unawareness Blood Glucose Mode Glucose BG Continuous Monitoring Mode Glucose CMYour FreeStyle Navigator system operates in two modes Install or Replace Transmitter and Receiver Batteries Key Terms Install or Replace Transmitter and Receiver Batteries Install or Replace the Transmitter Battery If the display is Check your work Reconnect the Receiver to the Transmitter Set the Time and Date Key Terms First time you use your FreeStyle Navigator system When you install new batteriesSet the Time and Date Go to the Main screen Select Set Date/Time from the System Menu screen Go to the System screenSet the time Set the date Customer Care Perform a Control Solution Test Key Terms Perform a Control Solution Test Prepare test strip Verify that your FreeStyle Control Solution is current Numbers do not match Insert test strip into the receiverCompare code numbers Numbers match Confirm that you used a control solution Apply control solution Falls Within Evaluate the test resultsFalls Outside Customer Care Insert or Remove Your Sensor Key Terms Every 5 days after that Insert or Remove Your Sensor Insert your sensor Decide what to do Remove the sensor Reconnect the receiver to Transmitter End sensor sessionSelect an insertion site An infection could occur Prepare the insertion siteRemove the sensor delivery Unit from package Remove the protective liner from the sensor support mount Inserting the sensor on your abdomen Attach the sensor delivery unit to your skinEnsure that the adhesive pad is adhered to your skin Inserting the sensor on the back of your arm Insert sensor Remove the locking pinRemove inserter Check the sensor support mount IfThen Discard the sensor inserter Safely Customer Care Attach Your Transmitter Key Terms Attach Your Transmitter Yes Attach the transmitter to the sensor support mount Enter the sensor code into your receiver Apply an over-bandage Optional Steps Do This Calibrate Your System/Test Blood Glucose Manually Key Terms Sterile lancets Sharps container Calibrate Your System/Test Blood Glucose Manually Insertion at night Helpful Information con’t Calibrate Your System/Test Blood Glucose Manually IfThen You are simply doing a manual Select a test site Important Do not touch the exposed needle on the lancet Prepare for lancing FreeStyle Lancing Device offers four different depth Prepare for lancing. con’tFinger Your forearm To lance your finger grey cap Lance the siteTo lance your forearm clear cap Use test strips more than once. Discard used test strips You get an error messageTest the sample Do Not Interpret the blood glucose results Confirm you didnot use Control Solution Discard the lancet Remove and discard the test strip Customer Care Set, Review, or Change the Alarm Settings Key Terms Set, Review, or Change the Alarm Settings About Glucose Alarms About Glucose Alarms con’t Access the Alarms menu From the Main menu Alarm on or off Your threshold value Set, review, or change the Low Glucose alarmAlarm type Setting Alarm on or off Your threshold value Alarm type Setting Set, review, or change the High Glucose alarm Medium Set, review, or change your Projected Low glucose alarmSensitivity to High Set, review, or change your Projected High glucose alarm Alarm on or off Alarm type Setting Set, review, or change the Data Loss alarmsUse the UP/DOWN Arrow buttons to highlight Data Set System Alarms Set Progress Tones You want to mute alarms Return to the main menu Mute all audible alarms for Hour Daily Use Key Terms Purpose Start Daily Use Reconnect the receiver to the transmitter If you want to Then go to this Step Interpret the CM screen Description Interpret the icons This Icon Means Second Turn the Backlight on Customer Care Respond to Alarms, Errors, and Problems Key Terms Can be muted Alarms are alphabetized in the following tablesMust never be ignored Cannot be muted Status Information Er1 This is normal for new sensors before System is not producing continuousTransmitter failure Sensor is expired Respond to alarm message con’t Cal Required Redo BG Select Link. If the transmitter ID that appears on If this message appears and you did not insert System has detected a new sensor Respond to alarm message con’t Replace the sensor within the next 2 hours see Respond to alarm message con’t Er4 Er1Er2 Er3 Calibration Connection Receiver will not turn on Then There is no glucose value on the screen Skin irritation at sensor insertion site Discomfort when inserting the sensor Then END of Section Add Events Key Terms Add Events Access the Add Event screen from the Main menu Record meal events Select the type of event you want to record Type Aerobics, Walking, Jogging, Running Record insulin eventsRecord state of health events Record exercise events Your glucose levels Record generic events Review Reports and Edit Events Key Terms Review Reports and Edit Events Access the Reports menu from the Main menuTo edit event history Set your glucose targets Decide what you want to do View a line graph of your glucose level history If you want to View a statistical summary of your glucose levels Percentage of readings that are Select the desired statistical readingYour average glucose reading How well you are maintaining your Review or change your event history Review/edit your All BG measures are displayed Interpret your events Edit the event Clean Your System Receiver Transmitter Contact Points Every time you change your sensor transmitter Clean Your System Clean your receiver skin Clean your transmitterClean your receiver Link and Unlink Your Transmitter and Receiver Key Terms BG Mode CM Mode Link/Unlink Receiver Transmitter Link and Unlink Your Transmitter and Receiver When you replace either your transmitter or your receiver Unlink your receiver from your transmitter If you want to Are not Link your receiver to your transmitter Customer Care Reset User Settings Customer Care Access the System menu from the Main menu Reset User Settings Reset your settings Access the Reset UserSettings screen Change Country Settings Key Terms Materials Change Country Settings Change the Language Access the Country Settings menuNone of the above Change the Time Format Change the Date Format Change the Decimal Format Appendix a Site Maintenance Appendix a Introduction Customer Care Appendix B Specifications Appendix B System Specifications 3rd calibration Must be performed between 12 Appendix B Specifications con’tDays of normal use including continuous glucose 1st calibration Must be performed at approximately Performance Characteristics Accuracy 155 Glucose mg/dL Performance Performance Relative to the Reference YSI Sensor Stability Performance Over the Duration of Wear Sample Glucose Traces Stability of Sensor Calibration Sample of a Representative ‘Excellent’ Glucose Trace Definitions Determination of Alarm Performance Detection of Low Glucose Measuring Glucose in Interstitial Fluid Appendix C FCC Compliance Information Customer Care Appendix C Classification/Compliance/Declaration Compliance Level Appendix C FCC Compliance Information con’tImmunity test Test Level Electromagnetic Environment- Guidance Input lines 40% Ut* for 5 cycles Battery Operated 168 Applicable to the frequency of the transmitter Classification Declaration of Conformity Customer Care Glossary Appendix C Classification/Compliance/Declaration Glossary 2020Glossary Continuous Glossary con’t 177 178 179 180 Index Customer Care Index 2121Index Index con’t