Arkon PRT03831-xxx - Manual

Table of Contents:

• Page 5 – How to Use this Guide?; Glossary of Symbols
• Page 6 – Table of Contents
• Page 9 – Getting Acquainted
• Page 10 – Section 1 – Key Terms; in vitro
• Page 11 – OVER; Introduction; before; Section 1; Getting Acquainted
• Page 12 – How are the parts packaged?; Your FreeStyle Navigator system comes with two kits:; The Sensor Kit; Bluetooth® technology.; NOT share your system with others
• Page 13 – What are the key parts of my system?; Sensor
• Page 14 – Key features of the System
• Page 15 – Using your system; For Daily Activities
• Page 16 – How do I prepare my system for the first time?; in the
• Page 17 – Warnings, Cautions And Important Notes; Important Things to Remember About System Calibration; NOT
• Page 18 – calibrated when the wearer is asleep.; Before You Get Started; has not been evaluated.
• Page 19 – There
• Page 20 – Helpful health related information:; not seen in the bloodstream until later.; of the system has not been evaluated.
• Page 21 – What is Hypoglycemia Unawareness?; Symptoms of Hypoglycemia Unawareness:; Hypoglycemia unawareness can develop for several reasons:
• Page 22 – What are the Continuous Monitoring mode and Blood; Your FreeStyle Navigator system operates in two modes:; END OF Section 1
• Page 23 – Install or Replace Transmitter and Receiver Batteries
• Page 24 – Section 2 – Key Terms
• Page 25 – Purpose; • The first time you use your FreeStyle Navigator system.; Materials; • 1 Silver Oxide 357 HC battery for the transmitter.; Helpful Information; may not be accurately monitored.; Section 2; Install or Replace Transmitter and Receiver Batteries
• Page 26 – Install or Replace the Transmitter Battery; When inserting the battery in the transmitter,; Note: The battery door must be closed securely to; Install or Replace the Receiver Batteries
• Page 27 – If the display is; NOT turn on, then repeat this
• Page 28 – Reconnect the Receiver to the Transmitter.; END OF Section 2; An operational system.
• Page 29 – Set the Time and Date
• Page 30 – Section 3 – Key Terms
• Page 31 – To ensure the correct time and date are associated with your data.; Start; Your FreeStyle Navigator Receiver.; reports depends upon the date and the time being correct.; Steps; Go to the Main screen.; b. Press the RIGHT Option button a second time to; Section 3; Set the Time and Date
• Page 32 – Go to the System screen.; a. Press the DOWN Arrow button to highlight System.; Select Set Date/Time from; a. Use the UP/DOWN Arrow buttons to highlight Set
• Page 33 – b. Use the UP/DOWN Arrow buttons to set the current; • If; END OF Section 3
• Page 35 – Perform a Control Solution Test
• Page 36 – Section 4 – Key Terms
• Page 37 – Do NOT; ONLY FreeStyle Control Solution and FreeStyle Test Strips.; Section 4; Perform a Control Solution Test
• Page 38 – Verify that your FreeStyle; Note: FreeStyle Control Solution is good for three months; after opening the bottle, or until the expiration date printed; Prepare test strip.; a. Locate the expiration date on the vial of FreeStyle; If strips are expired, obtain a new vial of strips.
• Page 39 – Insert test strip into the receiver.; at the lower left corner of the receiver.; Compare code numbers.; • The numbers do; If
• Page 40 – Apply control solution.; Do; ONLY ONE EDGE of the test strip to the; • If progres; Confirm that you used a; Note: If you do NOT select yes, the system will record the
• Page 41 – Evaluate the test results.; Control solution test results displayed on the; END OF Section 4; If the result; WITHIN the; • Falls; OUTSIDE of; • Is an error message.
• Page 43 – Insert or Remove Your Sensor
• Page 44 – Section 5 – Key Terms; Now that you are ready to insert a sensor, here are a few helpful tips.; Rec; BEFORE; LOOK for the; User’s Guide
• Page 45 – Keep the following in mind when inserting your sensor.; Section 5; Insert or Remove Your Sensor
• Page 46 – • Change or rem; If you want to
• Page 47 – edges of the sensor support mount.
• Page 48 – Reconnect the receiver to; If the sensor dislodges due to the sensor support
• Page 49 – Prepare the insertion site.; a. Remove the sensor delivery unit from its sterile package; Remove the protective liner from; a. Bend the two-piece protective liner slightly so you can
• Page 50 – Attach the sensor delivery unit; a. Locate the top of the sensor support mount.; Ensure that the adhesive pad is; a. Hold the sensor delivery unit firmly in place.; • Inserting the sensor on the; If you are
• Page 51 – Remove inserter; Remove the locking pin.; a. Grasp the top of the locking pin with your thumb and; both sides of the button at the same time.; a. Hold the sensor inserter and firmly squeeze the two; blue release tabs at the inserter’s base, as you lift the; Note: Do NOT lift the inserter without squeezing; the blue release tabs as this may dislodge the sensor
• Page 52 – Check the sensor support; a. Confirm the sensor support mount remains tightly; correctly
• Page 53 – Discard the sensor inserter; An inserted sensor, a removed sensor, or a; END OF Section 5
• Page 55 – Attach Your Transmitter
• Page 56 – Section 6 – Key Terms
• Page 57 – To enable the transmitter to send glucose data to the receiver.; Do this procedure after inserting a new sensor.; Your FreeStyle Navigator Transmitter with battery installed.; Section 6; Attach Your Transmitter
• Page 58 – Attach the transmitter to the; round part of the “keyhole”; Confirm the transmitter; • No
• Page 59 – Apply an over-bandage; a. When you hear the receiver beep, press the RIGHT; attaching the transmitter before the receiver beeps. See; Note: If you ever see this message at any other time,; number on the receiver screen to the number on the
• Page 60 – A transmitter ready to send glucose data.; END OF Section 6
• Page 61 – Calibrate Your System/Test Blood Glucose Manually
• Page 62 – Section 7 – Key Terms
• Page 63 – see a blood drop icon; • A FreeStyle Lancing Device.; Section 7; Calibrate Your System/Test Blood Glucose Manually
• Page 64 – You; Insertion at night; specific window of time.
• Page 65 – Some common reasons for unsuccessful calibrations
• Page 66 – Insert a FreeStyle Test Strip into; Compare the code number on the display with the code; a. Use the UP/DOWN Arrow buttons to change the; • The screen changes; MUST
• Page 67 – • You are calibrating the system.; Select ONLY a finger for testing (see red; • You are simply doing a manual; glucose test and NOT calibrating.; Select from among the sites shown; Calibration sites; Always calibrate the; ONLY
• Page 68 – Prepare for lancing.; a. Wash your hands and the selected test site with soap; and water. Make sure there is no lotion on the test site.; b. Thoroughly dry your hands and the test site.; Use a new sterile lancet for every test.; d. Insert a new FreeStyle Lancet firmly into the white; Do not touch the exposed needle on the lancet.; e. Hold the lancet firmly in place with one hand and use; your other hand to twist off the rounded top.; f. Replace the cap until it snaps or clicks into place.; If your test site is
• Page 69 – g. Select the lancing device depth setting.; • The FreeStyle® Lancing Device offers four different; h. Pull the dark grey cocking handle out until it clicks.; f you are lancing
• Page 70 – a. Lightly touch the lancing device against the side of; blood the size of a pinhead forms.; d. Lift the lancing device; straight up
• Page 71 – a. Holding the receiver at a slight angle to the sample, gently
• Page 72 – Interpret the blood glucose; Confirm you did NOT; If you do not select ‘No’ for the “Control Solution?”; Low or high glucose measurements can
• Page 73 – END OF Section 7; Remove and discard the test strip; Test strips may be used only once. Discard used; Note: Use a sealed container such as a sharps container; A properly calibrated receiver. You have done this
• Page 75 – Set, Review, or Change the Alarm Settings
• Page 76 – Section 8 – Key Terms
• Page 77 – minutes, 20 minutes or 30 minutes in advance of reaching your; Section 8; Set, Review, or Change the Alarm Settings
• Page 78 – About Glucose Alarms; when; High Threshold
• Page 80 – Access the Alarms menu; a. Press the UP Arrow button or the DOWN Arrow; button to highlight Alarms.
• Page 81 – a. Select Low Glucose from the Alarms menu.; • Press the; Note: The receiver will respond with a brief sample; • You are setting, reviewing, or changing; Note: The alarm can only be set; The Low Glucose alarm cannot be set below
• Page 82 – a. Select High Glucose from the Alarms menu.; The High Glucose alarm cannot be set above
• Page 83 – Projected Low glucose alarm.; a. Select Projected Low from the Alarms menu.; Sensitivity
• Page 84 – Projected High glucose alarm.; a. Select Projected High from the Alarms menu.
• Page 85 – If you turn off your Data Loss alarms, you must; a. Select Data Loss from the Alarms menu.
• Page 86 – If you turn off the System Alarms, the receiver; a. Select System Alarms from the Alarms menu.
• Page 87 – Set Progress Tones.; a. Select Progress Tones from the Alarms menu.
• Page 88 – END OF Section 8; Mute all audible alarms for; Note 1: You will still get vibration, visual alarms will still; Return to the main menu.
• Page 89 – Daily Use
• Page 90 – Section 9 – Key Terms
• Page 91 – Section 9; Daily Use
• Page 92 – Reconnect the receiver to the; Wait for the connection icon; If the receiver has
• Page 93 – Interpret the CM screen.; The Glucose CM screen is displayed.; Location; Before adjusting treatment for diabetes management based on the
• Page 94 – Interpret the icons.; Note: The directional trend arrows are different from the; This Icon
• Page 95 – END OF Section 9; Turn the Backlight on.; a. In order to turn the backlight on, your receiver has to
• Page 97 – 0 Respond to Alarms, Errors, and Problems
• Page 98 – Section 10 – Key Terms
• Page 99 – sound (beep or vibrate) until the display has been activated.; Must never be ignored.; If the level of
• Page 100 – Note: Once you select this option, the system will; Status Information
• Page 101 – Alarms and Errors
• Page 102 – VER; Cu
• Page 103 – on
• Page 105 – au
• Page 106 – gh
• Page 110 – ot
• Page 111 – Troubleshoot problems; Receiver
• Page 112 – a. Was the test strip inserted correctly (the “FreeStyle” side; the “FreeStyle” side is up as you insert the end with the; c. Are the batteries installed correctly?; and reset time and date.; e. Repeat the test with a new test strip.; re-installed in the receiver, you will have to reconnect; The receiver will not turn on.; b. If this did not resolve your problem call Customer Care.; The Blood Glucose test won’t start after you apply a sample.
• Page 113 – Unexpected characters on the receiver display screen, unusual
• Page 114 – There is no glucose value on the screen.
• Page 115 – Skin irritation at sensor insertion site.; c. If none of the above works, consult your healthcare; The sensor support mount is not sticking to your skin.; If the irritation is
• Page 116 – Discomfort when inserting the sensor.; a. Make sure that the transmitter is firmly
• Page 118 – Information on what to do in the event of alarm; END OF Section 10
• Page 119 – 1 Add Events
• Page 120 – Section 11 – Key Terms
• Page 121 – To create a record of events that may affect your glucose levels.; • Your FreeStyle Navigator Receiver.; much or how little detail you have provided.; SAVE to CANCEL before you press the RIGHT Option button (Set).; Access the Add Event screen; button to highlight Add Event.; Add Events
• Page 122 – Select the type of event you; b. Use the UP Arrow button or the DOWN Arrow; button to change the selected item.; Note: You can change the carbohydrate grams from; to 350 grams in 1 gram increments.; c. When you are done, press the RIGHT Option button; Your state of health.; If the event deals with
• Page 123 – Record insulin events.
• Page 124 – Record generic events.; b. Use the UP Arrow button or the DOWN Arrow button; An electronic record of all events that may affect; END OF Section 11
• Page 125 – 2 Review Reports and Edit Events
• Page 126 – Section 12 – Key Terms
• Page 127 – • To review your glucose levels.; • Your healthcare team will usually give you; Access the Reports menu from; a. Press the UP Arrow button or the DOWN Arrow; Review Reports and Edit Events
• Page 128 – Decide what you want to do.; a. Select Glucose Targets from the Select Report menu.; The settings are saved and the Select Report; f. Return to Step 2 to decide what to do next.
• Page 129 – View a line graph of your; a. Select Line Graphs from the Select Report menu.; • Notice your glucose target range (the shaded; Note: The line shows both your continuous readings; falling below; Press the RIGHT Option button to return
• Page 130 – View a statistical summary; a. Select Statistics from the Select Reports menu.; i) Use the UP Arrow button or DOWN Arrow button
• Page 131 – Select the desired statistical; for the; d. Go to Step 2 to determine what to do next.; If you want to know
• Page 132 – Review or change your; a. Select Event History from the Select Reports menu.; • Stop reviewing events.; Select the LEFT Option button to go to the
• Page 133 – Interpret your events.; a. Interpret the events using the notes about each type of; Event
• Page 134 – Note: You CANNOT edit your glucose measurements.; The result will be an increased awareness of your; END OF Section 12
• Page 135 – 3 Clean Your System
• Page 136 – Section 13 – Key Terms
• Page 137 – To maintain the appearance of your system.; • Every time you change your sensor (transmitter); Make sure you have access to these materials before you begin:; • Do; Clean Your System
• Page 138 – Clean your transmitter.; d. Shake any water out of the transmitter’s contact points; not excessively worn.; Clean your receiver skin.; A clean transmitter, receiver and receiver skin.; END OF Section 13
• Page 139 – 4 Link and Unlink Your Transmitter and Receiver
• Page 140 – Section 14 – Key Terms; BG Mode
• Page 141 – • When you replace either your transmitter or your receiver; Gather these materials before you begin:; You will; Link and Unlink Your Transmitter and Receiver
• Page 142 – a. Press the RIGHT Option button twice to display the; Unlinking your receiver from your transmitter; h. Go to Step 1 to decide what to do next.; • Unlink your receiver from your transmitter.
• Page 143 – Link your receiver to your; END OF Section 14; • Are; If the
• Page 145 – 5 Reset User Settings
• Page 147 – Note: The units of glucose; The default values are shown in brackets; Access the System menu; a. Press the UP or DOWN Arrow button to highlight; • High Glucose Target.; Reset User Settings
• Page 148 – Access the Reset User; Reset User Settings Screen.; Reset your settings.; Confirm what you want to do:; END OF Section 15; • Return your system to its; You should never reset your user settings
• Page 149 – 6 Change Country Settings
• Page 150 – Section 16 – Key Terms; LeFT/RIGhT Option Buttons
• Page 151 – will be lost if you haven’t pressed the RIGHT Option button (Select).; Select System screen.; Change Country Settings
• Page 152 – Access the Country Settings; Country Settings screen.; Change the Language.; a. Use the UP or DOWN Arrow button to highlight; Select Language screen.; c. Use the UP or DOWN Arrow button to highlight the; language that you want to use.; e. Go to Step 2c to decide what to do next.; If you want to change how
• Page 153 – Change the Date Format.; Select Date Format screen.; Change the Time Format.; Select Time Format screen.
• Page 154 – Change the Decimal Format.; Select Decimal Format screen.; c. Use the UP or DOWN Arrow button to select either the; The Country Settings screen is displayed.; A display that presents information in the format; END OF Section 16
• Page 155 – 7 Appendix A: Site Maintenance
• Page 156 – Section 17 – Appendix A; Adhesive enhancers
• Page 157 – Site rotation; change the insertion site each time a new sensor is used.; Helpful products; Choose from the list of products below as needed.; END OF Section 17; Appendix A: Site Maintenance
• Page 159 – 8 Appendix B: Specifications
• Page 160 – Section 18 – Appendix B; Calibration
• Page 161 – System Specifications; Appendix B: Specifications
• Page 163 – Performance Characteristics; Please
• Page 164 – Accuracy; Table 1
• Page 165 – Clinic study were used to determine the correlation.; av; Analysis
• Page 166 – Table 4a. Performance relative to YSI at different glucose levels; from the YSI; Table 5. Performance relative to YSI at different insertion sites
• Page 167 – Table 6b. Continuous Error Grid Analysis by day of wear
• Page 168 – performance within each period.
• Page 169 – Figure 2. Sample of a Representative ‘Excellent’ Glucose Trace
• Page 170 – Determination of Alarm Performance; The
• Page 171 – Detection of Low Glucose; Low Glucose Detection; Detection of High Glucose; High Glucose Detection
• Page 172 – END OF Section 18; Measuring Glucose in Interstitial Fluid; skin issues were observed in 304 site exams.
• Page 173 – 9 Appendix C: FCC Compliance Information
• Page 175 – Important Information about Electromagnetic Interference
• Page 177 – con
• Page 180 – Classification; The transmitter and receiver are classified as follows:; FCC Compliance Information; Transmitter; This device may not cause harmful interference.; eorient or locate the receiving antenna.
• Page 181 – DECLARATION OF CONFORMITY; END OF Section 19
• Page 185 – Glossary
• Page 193 – Index
• Page 194 – END OF Section 21