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User Guide

1. iPro User Guide Medtronic wal Medtronic MiniMed 18000 Devonshire Street Northridge CA 91325 USA 800 646 4633 818 576 5555 www medtronicdiabetes com 6025420 015_a REF MMT 7745 R Only 2011 Medtronic MiniMed Inc All rights reserved iPro Sen serter and CareLink are registered trademarks of Medtronic MiniMed Inc OneTouch OneTouch UltraLink OneTouch Ultra OneTouch Ultra 2 OneTouch UltraSmart OneTouch UltraMini are trademarks of LifeScan Inc Bayer BREEZE and CONTOUR are registered trademarks of Bayer MediSense Precision Xtra is a trademark of Abbott Laboratories Inc ACCU CHEK Aviva and ACCU CHEK Compact Plus are registered trademarks of Roche Diagnostics Corporation Microsoft Windows Windows Vista and Internet Explorer are registered trademarks of Microsoft Corporation Mozilla Firefox is a registered trademark of the Mozilla Foundation Adobe and Acrobat Reader are registered trademarks of Adobe Systems Incorporated ENZOL is a registered trademark of Johnson amp Johnson Clorox is a registered trademark of The Clorox Company Detachol is a registered trademark of Ferndale Laboratories Inc Contacts Africa Medtronic Africa Pty Ltd Tel 27 0 11 677 4800 Australia Medtronic Australasia Pty Ltd Tel 1800 668 670 product orders Tel 1800 777 808 customer help Azerbaijan Albatros Health Care Tel 994 12 498
2. Troubleshooting 70 CareLink iPro displayed this message during the upload process The iPro2 Recorder battery is not charging properly Please refer to the User Guide for assistance The red warning light on the Dock is on CareLink iPro displayed this message during the upload process Possible damage to iPro2 Recorder circuitry Please refer to the User Guide for assistance The red warning light on the Dock is on The iPro2 battery may be reaching the end of its life However this message may also appear if the iPro2 connector pins are damaged or corroded or if there is moisture in the connector opening There may be moisture damage or corrosion in the iPro2 connector opening or the iPro2 may need to be reset Disconnect the iPro2 and reconnect it to the Dock Allow the iPro2 to charge for 20 minutes The green charging light may flash at first but if the red warning light turns on again check the iPro2 connector pins for moisture damage or corrosion For assistance in locating the connector pins see Checking the iPro2 connector pins on page 73 If the red warning light continues to turn on perform a reset as described in Resetting the iPro2 on page 75 Please note that if you saw this error message in CareLink iPro the recent patient data was successfully uploaded but you may wish to confirm this before performing the reset If the Dock displays a solid green ch
3. iPro2 CGM User Guide Specifications and notices 90 Glossary Area Under the Curve AUC Indicates the amount in high and low excursions as determined by preset values Excursion data indicates the frequency of highs or lows AUC indicates the magnitude of events by showing how far out of range and for how long BG Blood Glucose BG reading Blood glucose measurement that is taken by a blood glucose meter Calibrate Check adjust or set to a standard Sensor data is calibrated using BG meter readings Cleaning plug Small plastic plug that you connect to the iPro2 before cleaning and disinfecting it The cleaning plug protects the iPro2 s connector pins from being damaged by water or cleaning fluids Docking Station Dock Device that performs two functions uploading glucose sensor data from an iPro2 to CareLink iPro and charging the iPro2 The Dock can be connected to a computer or to an electrical socket iPro2 Recorder iPro2 Device that continuously records sensor glucose data while connected to a glucose sensor You can upload the data to CareLink iPro by connecting the iPro2 to a Dock and view the sensor data on reports Logbook A screen in CareLink iPro that lets you manually enter events such as BG meter readings meals exercise and medication taken so that these events show up on reports The Logbook also displays BG meter readings and possibly other events that you upload from a supported blood glucose
4. Click Continue CareLink iPro tells you when the upload is successfully completed If you see a message that instructs you to see the User Guide please look up that message in Troubleshooting reference on page 66 Check the green charging light on the Dock iPro2 CGM User Guide Uploading data to CareLink iPro 44 Ifthe green charging light on the Dock is on and no longer flashing the iPro2 is charged and ready for the next patient If the green charging light is still flashing after the upload leave the iPro2 on the Dock to charge it so that it is ready for the next patient You can also choose to move the Dock to the wall powered adapter for charging the iPro2 or move the iPro2 to another Dock that is connected to a wall powered adapter if you have multiple iPro2 systems Uploading blood glucose meter data If the patient has been using a supported meter see Meters supported by CareLink iPro for uploading on page 6 you can upload meter data directly into CareLink iPro The software automatically puts the BG meter readings into the patient s CareLink iPro Logbook If the patient entered events on the meter such as meals medication exercise or other these events will also be automatically uploaded into the Logbook CareLink iPro will compare the time and date of the computer to the time and date of the meter If the meter time is incorrect CareLink iPro will use the computer s time to automatically correct the
5. e Items from patient jPro2 which has been worn by the patient Patient s blood glucose meter Completed Patient Log Sheet s e Gloves e Access to running water e Cleaning plug e Optional adhesive remover such as Detachol ENZOL enzymatic detergent Soft bristled brush e Bleach 6 sodium hypochlorite e Gauze pad or cloth e 70 isopropyl alcohol e Bio waste container Clinic Equipment Log if used by your office e Dock with the USB cable connected to a computer with Internet access e Meter manufacturer s cable Disconnecting the iPro2 and removing the sensor Disconnecting the iPro2 from the sensor 1 Put on gloves 2 Carefully remove any adhesive dressing from the iPro2 and sensor assembly iPro2 CGM User Guide Uploading data to CareLinkiPro 36 3 Hold iPro2 as shown and pinch the flexible side arms of the sensor between your thumb and forefinger Do not twist the iPro2 relative to the sensor 4 Gently pull the iPro2 away from the sensor assembly Removing the sensor from the patient While wearing gloves gently lift the sensor s adhesive tape away from the patient s body to remove the sensor Place the sensor in a bio waste container Cleaning and disinfecting the iPro2 The iPro2 is intended for multiple patient use Always inspect clean and disinfect the iPro2 before connecting it to the Dock The Dock cannot be disinfected See Precautions for additional information The
6. Can fix this Yes you can move the entire study from the incorrect patient record to the correct patient record For details see Moving a patient study on page 58 connected the iPro2 to the Dock and no lights came on The Dock may not be connected to the computer or it may not have sufficient power The white Dock power light must be on before connecting the iPro2 Try connecting the Dock to a different USB port on the computer Wait for all three lights to flash followed by a solid white light If the Dock is connected to the computer but none of the lights turn on there may be other USB devices connected that are using up power Disconnect other devices Do not connect more than one Dock at a time to a computer You can also try connecting the Dock to another computer If the white Dock power light is on but the three lights do not flash when you connect the iPro2 check the iPro2 connector pins for damage or moisture For assistance in locating the connector pins see Checking the iPro2 connector pins on page 73 If the pins are damaged or corroded the iPro2 cannot communicate with the Dock or CareLink iPro Contact the 24 Hour HelpLine It may be time to replace the iPro2 iPro2 CGM User Guide Troubleshooting 68 connected the iPro2 to the Dock and all three lights are flashing on and off repeatedly This could mean that the iPro2 is not properly connected to the D
7. If the iPro2 is inadvertently exposed to a strong magnetic field discontinue use and call the 24 Hour HelpLine e f performing multiple iPro2 studies on the same patient establish a rotation schedule for choosing new sensor sites e Avoid inserting a sensor in areas on the body that are constrained by clothing have scar tissue or are subject to rigorous movement during exercise e Wait 15 minutes after sensor insertion before connecting the iPro2 Make sure that the sensor insertion site is not bleeding before connection If you find blood on top of the sensor adhesive do not connect the iPro2 This is to prevent body fluids from getting into the iPro2 connector opening If blood gets inside the iPro2 s connector opening it may not be properly cleaned and disinfected without damaging the connector pins So the iPro2 will have to be discarded If bleeding occurs apply steady pressure with a sterile gauze or cloth at the insertion site until bleeding stops After bleeding stops attach the iPro2 to the sensor If bleeding persists after three minutes remove the sensor and discard Insert a new sensor in a different location e If body fluid comes into contact with the cleaning plug s connector or the Dock s connector the contaminated device must be discarded to prevent contamination of the iPro2 Do not allow fluids including water cleaning fluids and disinfectants on the iPro2 s connector opening or connector pins Fl
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10. The iPro2 recorder is suitable for use with a glucose sensor in the patient environment iPro2 CGM User Guide Specifications and notices 83 Guidance and manufacturer s declaration Guidance and Manufacturer s Declaration Electromagnetic Emissions The iPro2 CGM system is intended for use in the electromagnetic environment specified below The customer or the user of the iPro2 CGM system should assure that it is used in such an environment Emissions Test Compliance Electromagnetic Environment Guidance Re emissions Group 1 The iPro2 CGM system does not use RF energy for system CISPR 11 communication functions RF emissions Class B CISPR 11 amenic emissions The iPro2 CGM system is suitable for use in all Complies by establishments including domestic establishments and exemption those directly connected to the public low voltage power IEC 61000 3 2 re i supply network that supplies buildings used for domestic Voltage fluctuations flicker Purposes emissions Complies by exemption IEC 61000 3 3 iPro2 CGM User Guide Specifications and notices 84 Guidance and Manufacturer s Declaration Electromagnetic Immunity The iPro2 CGM system is intended for use in the electromagnetic environment specified below The customer or the user of the iPro2 CGM system should assure that it is used in such an environment Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment Gui
11. 32 2 Touch the end of the inserted sensor to prevent it from moving during connection 3 Hold the iPro2 as shown The flat side of the iPro2 should face the skin 4 Push the iPro2 onto the sensor until the sensor s flexible side arms snap into the notches on the iPro2 If the iPro2 is properly connected and if the sensor has had enough time to become hydrated within 10 seconds the iPro2 s green light will flash six times The flashing takes about 10 seconds 5 If the iPro2 s green light flashes then the sensor is fully hydrated and the iPro2 has successfully started the study 6 If the iPro2 s green light does not flash and the Dock displayed a solid green charging light before you removed the iPro2 from it then the sensor is not fully hydrated You can do either of the following a Remove the iPro2 from the sensor wait 15 minutes and then try connecting the iPro2 again This can be repeated every 15 minutes until the sensor is hydrated b Remove the sensor from the patient s body and insert a sensor in a new site on the body Wait 15 minutes for the new sensor to become hydrated before connecting the iPro2 again iPro2 CGM User Guide Patient setup 33 After you successfully connect the iPro2 to the sensor it is highly recommended to place an occlusive adhesive dressing over the iPro2 and the sensor This may help to keep the sensor in place under the skin Tip When applying the adhesive dressing secure the sensor firml
12. CGM User Guide Uploading data to CareLink iPro 38 5 If there is adhesive residue on the iPro2 you can remove it with adhesive remover for example Detachol between each patient use Follow adhesive remover manufacturer instructions 6 Rinse the iPro2 under cool tap water for at least one minute or until any visible debris is gone Prepare ENZOL Enzymatic Detergent solution using one ounce of detergent per gallon of water NOTE Cleaning efficacy testing and robustness testing were conducted on the iPro2 using ENZOL Enzymatic Detergent Robustness testing for the iPro2 included a contact time of one minute per cycle for 61 cycles which is equivalent to cleaning every three days for six months With the cleaning plug still attached fully submerge the iPro2 in the detergent solution for at least one minute iPro2 CGM User Guide Uploading data to CareLink iPro 39 9 10 11 12 13 Holding the cleaning plug remove the iPro2 from the solution Brush the entire surface of the iPro2 using a soft bristled brush paying close attention to hard to clean areas until visibly clean Rinse the iPro2 under cool tap water until any visible detergent is gone Dry any excess moisture by wiping the outside of the iPro2 with a clean dry cloth Prepare a 1 10 bleach solution by using one 1 part 6 bleach to nine 9 parts water for a final concentration of 0 6 Make sure to prepare a fresh s
13. Explorer menu options select Help gt About Internet Explorer 2 The amount listed after Cipher Strength is the SSL If this is less than 128 bit you need to upgrade your Internet Explorer See the procedure that follows 3 Click OK 4 After verifying that you have 128 bit encryption select Tools gt Internet Options from the Internet Explorer menu options 5 Click Advanced 6 Scroll down the list and make sure that Use SSL 3 0 is selected 7 Click OK Upgrading Internet Explorer If you need to upgrade your Internet Explorer to the latest version you can go to the Microsoft Internet Explorer Web site at http www microsoft com Follow the instructions provided by Microsoft to download and install the latest version of Internet Explorer Enabling SSL in Firefox 1 From the Firefox menu options select Tools gt Options The Options page is displayed 2 Click Advanced 3 On the Advanced page click the Encryption tab 4 On the Encryption tab make sure that Use SSL 3 0 is selected 5 Click OK Upgrading Firefox If you need to upgrade your Firefox to the latest version you can go to the Mozilla Web site at http www mozilla com iPro2 CGM User Guide One time CareLink iPro software and computer setup 23 Follow the instructions provided by Mozilla to download and install the latest version of Firefox Download and print resources After you are finished with setting up CareLink iPro for the clinic you can click
14. Internet browser settings on page 22 for additional information If you still cannot access the web site check with your network administrator to find out if your Internet access is restricted 2 If necessary click Change country language and follow the on screen instructions 3 Click the Register Clinic link near the bottom of the screen and follow the on screen instructions 4 When prompted enter the identifying information for your clinic and click Continue iPro2 CGM User Guide One time CareLink iPro software and computer setup 15 5 When prompted enter the identifying information for your administrative user account also known as Admin and click Continue You will sign in with this Admin user account to create user accounts for other users at the clinic 6 Click Finish to return to the Sign in screen Signin 1 Go to http www carelinkipro com If you just registered the clinic you will already be at this web site 2 Enter your username and password and click Sign in The Home tab for your clinic appears The clinic name will be at the top of the screen Your clinic s Patient List will be in the middle of the screen showing one sample patient record There will be no other patients listed until you have conducted studies using iPro2 If you want to sign out of CareLink iPro click Sign out near the top right corner of your screen Create user accounts Each staff member who might upload data from an iP
15. Report Settings for the patient but not apply them to any studies yet click No If you want to apply the new Report Settings for the patient to one or more studies find the study on the patient record screen and select Regenerate reports from the Other Options drop down list The reports are re generated using the new Reports Settings Restoring the default report settings If you want to set a patient s report settings to the current default settings for your clinic you can do this in the Patient Report Settings You will then have the option to choose which of the patient s studies you want to show the changes to the report settings 1 Click the Edit link in the Patient Report Settings section of the patient record screen The patient s General Report Settings and Overlay by Meal Report Settings are displayed Click the Restore defaults button on the patient s report settings screen Click Save A small window appears asking if you want to apply these report settings to the most recent set of reports To apply the settings to the most recent reports click Yes The report settings screen closes and the patient record screen appears where you can view and print the updated reports The new Report Settings have been applied to the most recent study You can then click any of the reports for the most recent study to view and print one of them or click Print All to print all of the reports To save the Report Settings for t
16. as the computer is on and the white Dock power light is on If you have multiple iPro2s you can use the wall powered adapters to keep them charged at power outlets and leave one Dock connected to the computer at all times so that it is ready to upload data iPro2 CGM User Guide System maintenance 63 Tip To extend the life of your Docks mark your calendar to periodically exchange the Dock that you have connected to the computer with a Dock that is connected to an electrical socket The Dock connected to the computer gets the most use and the connector pins can wear out over time Storage and organization tips When not in use store the iPro2 on the Dock and keep the Dock plugged in so that the iPro2 remains charged Otherwise the iPro2 battery could become damaged You can organize your other iPro2 supplies in a small drawer organizer such as the one shown here These are some of the items that you will want to keep on hand and ready for the next patient Sen serter Glucose sensors Occlusive adhesive dressings Alcohol swabs Liquid dishwashing detergent Adhesive remover Gloves Documents and forms including Patient Log Sheets Patient Consent Forms Patient Instructions Sheets Clinic Equipment Log sheets Clinic Checklists iPro2 CGM User Guide System maintenance 64 A printed copy of this User Guide Cleaning plugs Gauze pads ENZOL enzymatic detergent Bleach 6 sodium
17. change your password select the Change Password check box The password fields become active Type your new password in the Password field and re type it in the Re enter Password field 4 Modify the other information as needed 5 Click the Save button If you changed your password use your new password the next time you sign in Editing patient information You may occasionally need to update patient information such as the patient s name therapy type or physician Any user can update any patient s information for your clinic 1 On the patient record screen click the Edit patient information link 2 Update the patient s information as needed 3 Click the Save button The changes have been saved and any information that shows up on reports will be updated the next time you generate reports for the patient iPro2 CGM User Guide CareLink iPro ongoing use 57 Moving a patient study If you accidentally upload an iPro2 study to the wrong patient record in CareLink iPro you can move the study to the correct patient record Use the Clinic Equipment Log if needed to help you find the dates when each patient wore the iPro2 1 Confirm that the patient whose study was uploaded incorrectly has been added to CareLink iPro If the patient record does not exist yet you need to create it now For details see Opening the patient record on page 42 2 After you have confirmed that the correct patient exists in the system open the patient r
18. complete instructions see Cleaning and disinfecting the iPro2 on page 37 Cleaning the Dock The Dock cannot be disinfected This procedure is for general cleaning as required based on physical appearance WARNING Always clean and disinfect the iPro2 after removing it from the patient and before attaching it to the Dock If the Dock s connector comes in contact with blood the Dock must be discarded because the Dock s connector cannot be disinfected Dispose of the Dock according to the local regulations for electronic devices CAUTION The Dock is not watertight Do not immerse in water or any other cleaning agent Do not allow liquid to come in contact with the Dock s connector USB port or reset button Repeated exposure to liquid could damage the connector and affect the performance of the device If liquid comes in contact with the connector allow the Dock to air dry before proceeding with the cleaning instructions 1 Disconnect the Dock USB cable from the computer or wall powered adapter 2 Disconnect the Dock from the USB cable 3 Use a damp cloth with mild cleaning solution such as a dishwashing detergent to clean any dirt or foreign material from the outside of the Dock Never use organic solvents such as paint thinner or acetone to clean the Dock 4 Place the Dock on a clean dry cloth and allow it to air dry completely 5 When the Dock is completely dry you can reconnect it to the computer or wall powered ad
19. hypochlorite 70 isopropyl alcohol Soft bristled brush iPro2 CGM User Guide System maintenance 65 Troubleshooting This appendix contains troubleshooting information for the iPro2 CGM System Please refer to these instructions before contacting the 24 Hour HelpLine Troubleshooting reference connected the iPro2 to the sensor and the iPro2 did not flash after 10 seconds Either the sensor is not adequately hydrated the iPro2 is not connected properly or the iPro2 is not ready to begin a study Did you take the iPro2 directly from a powered Dock and did the Dock display a solid green charging light If yes then the iPro2 may not be connected properly or the sensor may not be fully hydrated Disconnect and reconnect the iPro2 If this does not work wait another 15 minutes and then connect the iPro2 to the sensor again If the iPro2 still does not flash wait another 15 minutes and try again In some cases it can take up to two hours for the sensor to become hydrated If the iPro2 still does not flash after two hours you can remove the sensor and insert a new sensor in a different site on the body If no or if you are not sure the iPro2 may not be fully charged or may still contain data from a previous study In these cases the green light will not flash when connected to the sensor Disconnect the iPro2 from the sensor Clean and disinfect it see Cleaning and disinfecting the iPro2 on
20. iPro2 can be used 60 times Keep track of iPro2 uses by entering each use on the Clinic Equipment Log Discard the iPro2 after 60 uses If you continue to use the iPro2 beyond 60 times the disinfection process may damage the device 1 It is strongly recommended to print a copy of the Clinic Checklist to guide you through these steps As you complete each step mark it as complete on the checklist to make sure that you do not miss any steps 2 Put on gloves 3 Inspect the inside of the connector opening for any sign of body fluid iPro2 CGM User Guide Uploading data to CareLinkiPro 37 CAUTION The person inspecting the iPro2 must have sufficient vision that enables him or her to see small drops of body fluid or debris WARNING If you see any body fluid in the connector opening you must discard the iPro2 Because the iPro2 contains a battery do not discard in a bio waste container Instead continue to clean and disinfect the iPro2 and then discard according to local regulations for battery disposal non incineration connector opening connector pins housing 4 Important The cleaning plug is a required component for cleaning and disinfecting The cleaning plug ensures that fluids do not contact the iPro2 s connector pins Fluids can cause the connector pins to corrode and affect the iPro2 s performance Do not twist the cleaning plug while it is attached to the iPro2 This will damage the iPro2 iPro2
21. need to perform a setup task on each computer that will be used for uploading sensor data from an iPro2 iPro2 CGM User Guide One time CareLink iPro software and computer setup 14 e Usernames must be unique among all CareLink iPro clinics in the system not just your clinic e Choose at least two people to be administrative users One of them should complete the CareLink iPro setup for the clinic Register clinic and create administrative user When you access CareLink iPro for the first time you will be guided through a process to register your clinic and create an administrative user The administrative user is the person who will create add and delete user accounts for the rest of the clinic s staff CAUTION Choose one person to be the first administrator for your clinic and register your clinic only once using the Register Clinic link Do not create more than one clinic account for your clinic If each user registers another clinic then the patient records will be divided into separate clinic accounts and will not be accessible to all users 1 On the computer open your Internet browser and go to http www carelinkipro com NOTE On Windows 8 from the Start screen click the Desktop tile and make sure you are viewing the desktop before you open your browser If you have any trouble accessing the CareLink iPro web site check your web browser settings to verify that JavaScript and SSL 3 0 are enabled See Required
22. page 37 and then connect it to the Dock If the green charging light on the Dock turns solid after two minutes the iPro2 is ready to start a study on a new patient If not the iPro2 needs to be charged or still contains patient data from the previous study If these steps do not work use the Dock to reset the iPro2 For instructions see Resetting the iPro2 on page 75 iPro2 CGM User Guide Troubleshooting 66 The iPro2 has been connected to the Dock with adequate power for two to three hours but the green charging light keeps flashing The reports only show a partial study Data ends before study was supposed to end The iPro2 most likely contains data that has not been uploaded A common cause of a partial study is sensor pullout If the sensor was not pulled out the iPro2 battery may not have had sufficient power to complete the study CareLink iPro checks the iPro2 battery and displays a message during the upload process to warn you that there might be a problem The iPro2 Recorder battery is not charging properly Please refer to the User Guide for assistance Also the Dock displays a solid red warning light when there may be a problem with the iPro2 battery Check the Clinic Equipment Log or Patient Log Sheets to find out which patient s data was last collected Open CareLink iPro and check to see if a study was uploaded for the dates on the log sheet If there is no study up
23. signs are noted the device must be discarded according to local regulations for battery disposal non incineration Place the iPro2 on a clean dry non shedding cloth and air dry completely Discard used gloves before proceeding Proper performance of the iPro2 is indicated by the lights on the Dock After you finish the disinfection process you must upload the patient data as instructed in the following sections If you see a red warning light on the Dock after connecting the iPro2 see Troubleshooting reference on page 66 Opening the patient record On the computer open your Internet browser and go to http www carelinkipro com Sign in to CareLink iPro using your username and password If you are already signed in click the Home tab Type any of the following into the Search box to find the patient record First name Last name Patient ID Date of birth As you type the Patient List displays matching patient records from previous iPro2 studies When you see the patient in the list select the patient and click the Open patient button You can also double click the patient in the list If you do not see the patient in the Patient List click the New patient button to add the patient to CareLink iPro The Create new patient record screen is displayed CAUTION Make sure to thoroughly search for the patient in CareLink iPro before adding a new patient record If your clinic has already conducted a study for th
24. the sensor insertion site The iPro2 must be removed but the sensor can be left in prior to an x ray CT scan or MRI Simply reconnect the iPro2 afterward Make sure that the patient can return the iPro2 to the clinic well within 10 days of the end of the study After 10 days if the iPro2 is not connected to a powered Dock the iPro2 battery may lose its charge and all data on the iPro2 could be lost Preparing to connect the iPro2 after briefing the patient 1 If bleeding has occurred a When bleeding stops attach the iPro2 to the sensor CAUTION If bleeding does NOT stop do NOT connect the iPro2 to the sensor 2 If bleeding does not stop after three minutes do the following a Remove the sensor and discard b Reapply pressure using a sterile gauze or cloth until the bleeding stops c Insert a new sensor in a different location Connecting the iPro2 to the sensor Important The iPro2 must be fully charged and cleared of data before connecting to a sensor You can verify this by connecting the iPro2 to the Dock When you connect the iPro2 to the Dock if the green charging light is on not flashing as shown below the iPro2 is fully ready to use If you see a red warning light while the iPro2 is connected to the Dock do not connect the iPro2 to the sensor See Troubleshooting reference on page 66 1 Make sure that it has been at least 15 minutes since you inserted the sensor iPro2 CGM User Guide Patient setup
25. which there is no sensor data Therefore there are no sensor values on the reports for that day The Daily Summary graph for that day shows only BG meter readings plotted if there are any and no sensor data C No Calibration BG s This designation occurs on a calendar day in which there are sensor values available but there are no valid BG meter readings with which to calibrate the sensor values Sensor data that cannot be calibrated will be missing from the reports for that day iPro2 CGM User Guide CareLink iPro reports 52 Area under the curve AUC Area under the curve AUC information appears in the Excursion Summary on the Daily Overlay Report AUC provides more insight into how much time the patient s glucose was high or low as well as the severity of excursions outside of the target range A high AUC indicates more excursions or more severe excursions The closer that AUC is to zero the more that the patient s glucose stayed within the target range AUC calculations are reported in mg dL per day or mmol L per day The Daily Overlay Report provides two AUC amounts for each day AUC Above Limit and AUC Below Limit e AUC Above Limit this statistic provides a relative indication of the overall extent and duration of high glucose excursions over the entire day The calculation is dependent on the patient Glucose Target Range High setting The High limit value is subtracted from each individual sensor glucose value that exceeds the
26. 2 and the patient leaves the office but not any sooner than one hour Write this time on the front of the Patient Log Sheet Two hours after the first BG meter reading three hours after the iPro2 is connected e Once more before midnight Remaining days e For the remaining days of the study collect at least four BG meter readings per day preferably before breakfast lunch dinner and bedtime e The patient should do at least three BG meter readings on the last day before the sensor is removed Care and wearing instructions The patient can shower and swim without removing the iPro2 or sensor The iPro2 and sensor are watertight for up to 30 minutes up to a depth of 8 feet 2 4 meters There is no time limit for swimming on the surface of the water or showering iPro2 CGM User Guide Patientsetup 31 The patient should periodically check the sensor site to ensure that the sensor and iPro2 are tightly connected that the sensor is fully inserted and that there is no bleeding or irritation at the sensor site e If the sensor is partly pulled out attempt to gently push it back into place e Remove the sensor if there is redness pain tenderness or swelling at the site The patient should notify the physician s office if experiencing any of these symptoms Insulin should be injected at least 3 inches 7 5 centimeters away from the sensor insertion site and insulin pump infusion should be at least 2 inches 5 centimeters from
27. 2 will keep recording but the values on the second sensor will vary widely for many hours because the iPro2 will not properly start the second sensor For the best results upload data after each sensor use Preparation for sensor insertion uu Fb W N Ask your patient about sleeping position and about his or her normal daily routine Does the patient exercise or do a lot of bending or lifting at work What kind of clothing does the patient normally wear Are there other activities that could disturb a sensor site such as prolonged sitting in a driving position in a car Choose a site that will be protected Wash your hands thoroughly Put on gloves Ask the patient to stand Clean the insertion site with alcohol and allow to air dry a D NOTE Do not use sticky skin preparation solutions before inserting the sensor A sticky intravenous I V preparation solution may be used after the sensor is inserted and before applying an occlusive adhesive dressing to help the adhesive stick to the patient s skin Always refer to the instructions that came with the glucose sensor and the sensor insertion device Inserting the sensor Refer to your Sensor User Guide for information on sensor insertion CAUTION If you see body fluid on the metal sensor contacts or black o rings do not connect the iPro2 Remove and dispose of the sensor and insert a new sensor This will prevent contamination of the iPro2 iPro2 C
28. 9537 Bangladesh Sonargaon Healthcare Pvt Ltd Mobile 91 9903995417 or 880 1714217131 Belarus Badgin Ltd Tel 375 172 665128 Belgi Belgique N V Medtronic Belgium S A Tel 0800 90805 Bosnia and Herzegovina Intermedical Tel 387 33 202 183 Fax 387 33 202 183 Brasil Medtronic Comercial Ltda Tel 11 3707 3707 Bulgaria Interagro 90 Ltd Tel 359 888 636 033 Canada Medtronic of Canada Ltd Tel 1 800 284 4416 toll free sans frais China Medtronic Shanghai Ltd 24 Hour Help Cell 86 400 820 1981 24 Hour Help Landline 86 800 820 1981 Croatia Oktal Pharma Tel 385 16595777 Fax 385 16595701 Croatia Medtronic B V Tel 385 1 488 11 20 Fax 385 1 484 40 60 Danmark Medtronic Danmark A S Tel 45 32 48 18 00 Deutschland Medtronic GmbH Gesch ftsbereich Diabetes Telefon 49 2159 8149 370 Telefax 49 2159 8149 110 24 Stdn Hotline 0800 6464633 Eire Accu Science LTD Tel 353 45 433000 Espana Medtronic Ib rica S A Tel 34 91 625 05 42 Fax 34 91 625 03 90 24 horas 34 901 120 335 Europe Medtronic Europe S A Europe Middle East and Africa Headquarters Tel 41 0 21 802 7000 France Medtronic France S A S Tel 33 0 155 38 17 00 Hellas Medtronic Hellas S A Tel 30 210677 9099 Hong Kong Medtronic International Ltd Tel 852 2919 1300 To order supplies 852 2919 1322 24 hour helpline 852 2919 6441 India
29. BG meter reading times Do not change the time or date on the meter before uploading NOTE If you have uploaded the iPro2 and there has been a time change contact the 24 Hour HelpLine for assistance in uploading the meter If the patient has been using a meter that is not listed in Meters supported by CareLink iPro for uploading on page 6 you can enter BG meter readings manually See Entering Patient Log Sheet data on page 46 for instructions NOTE You can upload only one meter per study 1 If you have just finished uploading the iPro2 you will be prompted to select the patient s meter after you click Continue You can also choose to enter BG meter readings manually using the Logbook For details see Entering Patient Log Sheet data on page 46 iPro2 CGM User Guide Uploading data to CareLink iPro 45 2 Follow the on screen instructions 3 When prompted connect the meter to the computer using the appropriate cable supplied by the meter manufacturer CareLink iPro tells you when the upload is successfully completed 4 Disconnect the meter from the computer Entering Patient Log Sheet data The Logbook screen in CareLink iPro allows you to manually enter BG meter readings and other events that the patient recorded on a Patient Log Sheet such as meals medication exercise or other You can also exclude BG meter readings from being used for sensor calibration or remove manually entered events from the pati
30. CareLink iPro clinics in the system not just your clinic If the username you entered is not available the system informs you that you must try a different username 7 Make a note of the username and password so that you can provide them to the user He or she will need this information to sign in and select a new password Repeat this procedure for each user account that you need to create Set clinic report settings The Clinic Report Settings are the default settings for each new patient record They are like a template for new patient records iPro2 CGM User Guide One time CareLink iPro software and computer setup 17 NOTE Changing the Clinic Report Settings does not affect any existing patient studies or reports If a particular patient has unique needs you will be able to override these settings later for individual patients as needed 1 Click the Clinic Settings tab The Report Settings for the clinic are displayed If you do not see the Clinic Settings tab click the Home tab You should now see the Clinic Settings tab 2 In Report Settings set the General Report Settings and the Overlay by Meal Report Settings For more information about these settings see the following two sections or click the help icon E in CareLink iPro for each section 3 When you are finished click Save The clinic settings take effect for all new patients added to the system after you change the settings Previously added patient
31. GM User Guide Patient setup 29 Make an entry on the Clinic Equipment Log and the Patient Log Sheet Make sure to write down the serial number SN of the iPro2 the patient s name or ID and the date that you placed it on the patient Medtronic MiniMed REF MMT 7741 GT 5XXXXXXM X J You now need to wait at least 15 minutes before connecting the iPro2 to allow the sensor to become hydrated with interstitial fluid Take this time to brief your patient on what to do when he or she goes home Briefing the patient The patient must receive detailed instructions on wearing the sensor and iPro2 study compliance meter use and maintaining a log sheet Ideally provide the patient with a Patient Log Sheet and a Patient Instructions Sheet Go over the items listed on each of the documents and make sure that your patient understands his or her responsibilities to ensure a successful study Key points Wear the iPro2 continuously while following normal daily activities Record meals blood glucose exercise or strenuous activities and medications on a Patient Log Sheet Keep the Patient Log Sheet accessible at all times so that information can immediately be written down after each event Record the time and date within five minutes of each BG meter reading Use the same glucose meter and the same lot of strips for the entire study Do not let anyone else use the meter during the study Do not use control soluti
32. If you are finished using the Logbook click Continue to return to the patient s main record screen The reports are regenerated automatically Removing Logbook entries You may sometimes want to remove events from the Logbook so that they do not show up on the patient s reports You can remove Logbook entries that have been entered manually Events that were uploaded from a meter cannot be removed They can only be excluded from calibration 1 In the patient s Logbook screen click on a Logbook entry to select it and then click the Remove button 2 A small window appears asking you to confirm that you want to remove the item Click Remove The event no longer appears in the Logbook When you view the patient s reports the events that you removed will not be shown on the reports 3 If you are finished using the Logbook click Continue to return to the patient s main record screen The reports are regenerated automatically Sorting the Logbook entries You can sort the events in the Logbook by clicking on a column heading This can help you find items in the Logbook It does not affect how patient data appears on reports You may need to click the column heading twice to reverse the sort order iPro2 CGM User Guide Uploading data to CareLinkiPro 48 CareLink iPro reports viewing and printing reports Key Notes e You can modify a patient s Report Settings such as the glucose target range and meal periods and re gen
33. Link iPro users 59 Logbook entries 47 electromagnetic immunity 85 enrolling clinic 15 entering log sheet data 46 equipment log printing new copies 24 using 30 43 erasing iPro2 data 75 Excel data export 55 excluding BG meter readings 47 exercise entering in Logbook 46 exporting data 55 FAQs 66 Firefox SSL enabling 23 upgrading 23 first day of study 31 first patient visit 25 first time setup device setup 10 software setup 14 flashing light 74 frequently asked questions 66 G general report settings 18 generating CSV file 55 Data Table report 55 generating reports tips for success 50 glucose sensor connecting iPro2 32 inserting 29 glucose units system default setting 17 green light 74 guidance and manufacturer s declaration 84 guidelines for successful reports 50 iPro2 CGM User Guide Index 94 icons 89 indications for use 4 inserting sensor 29 installation of software 19 instructing patient 30 interference from wireless devices 9 Internet browser required settings 22 Internet Explorer 22 enabling SSL 23 upgrading 23 iPro2 about 2 charging 63 cleaning and disinfecting 27 37 62 connecting to sensor 32 disconnecting from patient 36 preparing to connect to patient 32 removing from patient 36 resetting 75 setup first time 10 system components 2 uploading data 43 iPro2 instructions care and wearing instructions 31 J Java installation 19 JavaScript enabling 22 L lights quick reference 74 log
34. R red light 74 registering clinic 15 removing CareLink iPro users 60 iPro2 from patient 36 Logbook entries 48 sensor from patient 36 report settings clinic 17 general 18 Overlay by Meal 18 restoring default patient settings 54 reports about 49 51 area under the curve AUC 53 clinic report settings 17 CSV file 55 Daily Overlay 51 Daily Summary 51 Data Table 55 General Report Settings 18 optimal accuracy 51 Overlay by Meal 51 Overlay by Meal Report Settings 18 patient report settings 53 printing 50 restoring default patient report settings 54 tips for success 50 viewing 50 required browser settings 22 enabling JavaScript 22 SSL settings 23 reset button key notes 13 resetting iPro2 75 resources downloading and printing 24 restoring default patient report settings 54 S Secure Sockets Layer SSL required browser settings 23 sensor connecting iPro2 32 inserting 29 removing from patient 36 uploading data 43 setting clinic report settings 17 setting up computers for uploading 19 setup CareLink iPro software 14 clinic 15 computers for uploading 19 iPro2 recorder 10 patient 25 user accounts 16 signing in to CareLink iPro 16 software drivers 19 software installation 19 software requirements 7 sorting Logbook entries 48 specifications 82 spreadsheet data export 55 storage and organization tips 64 study preparing for 26 support software requirements 7 supported blood glucose meters 6 symbols 89 system mainten
35. aining a minimum distance between portable and mobile RF communications equipment transmitters and the iPro2 digital recorder as recommended below according to the maximum output power of the communications equipment Separation distance according to the frequency of transmitter m Rated maximum 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 6 0 GHz alba wey d 1 2 P d 1 2 P d 2 3 P 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 74 1 1 2 I2 2 3 10 3 8 3 8 7 4 100 12 12 23 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be estimated using the equation applicable to the frequency of the transmitter where p is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people iPro2 CGM User Guide Specifications and notices 87 Warranty Medtronic Diabetes warrants the iPro2 and Dock to the purchaser of the product against defects in material and workmanship for a period of one year from the date of purchase During the warranty period Medtronic Diabetes will repair or replace at its discretion any defective iPro2 or Dock subject to the condi
36. ake sure that the Dock is connected to the computer by checking both ends of the Dock USB cable for a complete connection The white Dock power light indicates that it is connected to a power source such as a computer or wall powered adapter iPro2 CGM User Guide Uploading data to CareLinkiPro 43 7 If you do not see the white Dock power light the Dock may have insufficient power to operate If it is the only device connected try plugging the Dock into a different USB port directly on the computer Not all USB ports may get sufficient power for the Dock to operate You can also connect the Dock to the computer using a USB hub However if the white Dock power light does not turn on then try using a powered USB hub which has its own electrical plug that is connected to an electrical socket When instructed by CareLink iPro connect the iPro2 to the Dock WARNING Always inspect the iPro2 connector opening for body fluid Always clean and disinfect the iPro2 after removing it from the patient and before attaching it to the Dock CAUTION Do not connect more than one Dock to the computer at one time Only connect the iPro2 associated with the opened patient record to the Dock The three lights on the Dock will flash once when you connect the iPro2 Then the green l charging light on the Dock will start flashing Fk This indicates that the iPro2 contains data that needs to be uploaded or that the iPro2 is charging
37. al commercial or hospital environment iPro2 CGM User Guide Specifications and notices 85 Guidance and Manufacturer s Declaration Electromagnetic Immunity The iPro2 CGM system is intended for use in the electromagnetic environment specified below The customer or user of the iPro2 CGM system should assure that it is used in such an environment immunity kest sean Compliance Level Electromagnetic Environment Guidance Portable and mobile RF communications equipment should be used no closer to any part of the iPro2 CGM system including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance Conducted RF 3 Vrms 150 kHz to 3 Vrms d 1 24 P IEC 61000 4 6 80 MHz d 1 2 P 80 MHz to 800 MHz Radiated RF 3 V m 80 MHz to 3 V m IEC 61000 4 3 6 0 GHz d 2 34 P 800 MHz to 6 0 GHz Where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol G NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all si
38. alue must be at least 2 2 and must be at least 0 01 mmol L below the high value The format for entering the high value for the target range is xx x for example 12 3 The range can be from 3 3 to 16 6 Time periods are used to identify which meal to associate with each meal marker For example if the breakfast time period is set from 6 00 a m to 10 00 a m and lunch is set from 10 00 a m to 3 00 p m then a meal marker entered for 9 30 a m would be interpreted as a breakfast marker and a meal marker entered for 12 30 p m would be interpreted as a lunch marker The duration of each period must be at least 0 5 hours The end time of a period can be different from the start time of the next period so gaps between periods may exist The one exception to this rule is that the end of Evening must be the same as the start of Sleeping A post meal analysis is used to generate statistics from data collected following a meal The Post Meal Analysis window can extend up to 4 0 hours after a meal event The duration of the analysis window must be at least 0 5 hours The start time can range from 0 0 to 3 5 and the end time can range from 0 5 to 4 0 Set up computers for uploading CareLink iPro needs Java and certain hardware drivers to be installed in order to upload patient data You also need Adobe Reader installed in order to view CareLink iPro reports Before you begin please note e Ifyou do not have Windows administrative privileg
39. amage or corrosion For assistance in locating the connector pins see Checking the iPro2 connector pins on page 73 If the iPro2 pins are damaged or corroded the iPro2 cannot communicate with the Dock or CareLink iPro Contact the 24 Hour HelpLine It may be time to replace the iPro2 CareLink iPro displayed this message during the upload process iPro2 Recorder is not responding Please confirm the connected device is an iPro2 Recorder and try again The red warning light on the Dock is on The Dock only works with iPro2s You may be trying to upload the wrong device The iPro2 has an i on the front of it If you are trying to upload an original iPro digital recorder you must use a ComLink and upload it into Solutions Software for CGMS iPro If the device is a MiniLink it cannot be used for an iPro2 CGM study If you are sure that the device is an iPro2 it may not be properly connected Try disconnecting the iPro2 from the Dock and then reconnecting it If the problem continues check the iPro2 connector pins for moisture damage or corrosion For assistance in locating the connector pins see Checking the iPro2 connector pins on page 73 If the pins are damaged or corroded contact the 24 Hour HelpLine It may be time to replace the iPro2 If the iPro2 connector pins are not damaged the iPro2 may need to be reset For instructions see Resetting the iPro2 on page 75 iPro2 CGM User Guide
40. ance 61 system overview 2 system requirements computer 7 T target glucose range setting system default 17 time display setting system default 17 tips for patient studies 28 tips for storage and organization 64 tips for successful reports 50 troubleshooting about 66 CareLink iPro 70 connector pins 73 Data Table report 55 troubleshooting reference 66 U upgrading Firefox 23 upgrading Internet Explorer 23 uploading iPro2 data 43 meter data 45 supported meters 6 uploading data about 35 iPro2 CGM User Guide Index 96 user accounts creating 16 17 59 deleting 60 modifying 59 user safety about 4 contraindications 4 indications for use 4 precautions 5 warnings 4 V viewing Logbook entries 48 patient reports 50 WwW wall powered adapter about 2 warnings 4 warranty 88 watertightness Dock 62 white light 74 wireless devices interference 9 iPro2 CGM User Guide Index 97
41. apter with the USB cable Components that cannot be cleaned You cannot clean the following components of the iPro2 system e Cleaning plugs discard each cleaning plug after 30 uses e Wall powered adapter e Dock USB cable iPro2 CGM User Guide System maintenance 62 Charging the iPro2 between studies Charge the iPro2 in the Dock The Dock can be connected to the computer or to the wall powered adapter which lets you use a regular power outlet for charging While the iPro2 is charging the green charging light on the Dock is flashing as shown Between patient studies the iPro2 should take less than 30 minutes to reach a full charge When the iPro2 is fully charged the green charging light on the Dock remains on CAUTION If the green charging light continues to flash and never turns solid this indicates that the iPro2 contains patient data that you have not uploaded You cannot use the iPro2 for another study until you upload the data If you need to clear the data without uploading it you can perform a reset For details see Resetting the iPro2 on page 75 Always leave the iPro2 connected to a powered Dock when not in use This maintains the life of the iPro2 battery and keeps the iPro2 ready for the next patient study If your clinic has only one iPro2 you can leave the Dock connected to the computer and connect the iPro2 to the Dock when not in use The computer supplies enough power to charge the iPro2 as long
42. arging light the reset was successful If the iPro2 connector pins are damaged or corroded or the Dock still displays a red warning light for the iPro2 after the reset contact the 24 Hour HelpLine It may be time to replace the iPro2 Disconnect the iPro2 and reconnect it to the Dock Charge the iPro2 for 20 minutes If the Dock displays a solid green charging light the reconnection was successful If the green charging light flashes at first and then the red warning light turns on check the iPro2 connector pins For assistance in locating the connector pins see Checking the iPro2 connector pins on page 73 If you do not find any problems inside of the connector opening and the green charging light never remains on without flashing when you connect the iPro2 to the Dock perform a reset as described in Resetting the iPro2 on page 75 and charge the iPro2 for one hour Please note that if you saw this error message in CareLink iPro the recent patient data was successfully uploaded but you may wish to confirm this before performing the reset If the Dock displays a solid green charging light the reset was successful If the red warning light continues to turn on contact the 24 Hour HelpLine It may be time to replace the iPro2 iPro2 CGM User Guide Troubleshooting 71 CareLink iPro displayed this message during the upload process Transfer failed An unrecoverable data error has been detected in the device
43. count information appears 3 If you want to edit the user account information such as the password enter the information and click the Save button Deleting user accounts If you have administrative privileges you can delete a user account You need to delete user accounts for users who no longer should have access to CareLink iPro for your clinic so that they can no longer access patient records 1 In the Clinic Settings tab click Users The existing user accounts are displayed 2 Select the user account and click the Open user button The user account information appears 3 If you want to delete the user account click the Delete User button 4 Inthe confirmation screen click Yes iPro2 CGM User Guide CareLink iPro ongoing use 60 System maintenance cleaning and disinfecting storing equipment Key Notes e Always connect the cleaning plug to the iPro2 before cleaning e When not in use leave the iPro2 connected to the Dock so it will be ready for use with the next patient e If an iPro2 is unused for several weeks you must store it on a powered Dock Otherwise the iPro2 battery could become damaged e Keep extra Patient Log Sheets and other iPro2 supplies in an organized cabinet iPro2 CGM User Guide System maintenance 61 Cleaning the iPro2 Always clean and disinfect the iPro2 after removing it from a patient Make sure to connect the cleaning plug to the iPro2 before cleaning and disinfecting For
44. dance Electrostatic discharge ESD 8 kV indirect 8 kV 30 60 relative humidity Floor should be wood concrete or ceramic tile If floors are covered with 22 kV air synthetic material the IEC 61000 4 2 8 kV air lt 5 relative relative humidity should be humidity at least 30 Electrical fast transient 2 kV for power supply 2 KV Mains power should be burst lines that of a typical commercial or hospital IEC 61000 4 4 T for input output 1 kV environment Surge 1 kV line s to line s 1 kV Mains power should be that of a typical IEC 61000 4 5 2 kV line s to earth 2 kV a hospital lt 5 Uy gt 95 dip in Uy lt 5 U Mains power should be for 0 5 cycle i that of a typical commercial or hospital 40 Uz7 60 dip in U7 environment If the user of Voltage dips short for 5 cycles 40 Ur the iPro2 CGM system interruptions and voltage requires continued variations on power supply 70 Uy 30 dip in Up 70 U operation during power lines for 25 cycles T mains interruptions it is IEC 61000 4 11 recommended that the iPro2 CGM system be lt 5 Ur gt 95 dip in Uy lt 5 U powered from for 5 seconds T uninterruptible power supply or battery Power frequency magnetic Power frequency fields should be at levels 50 60 Hz magnetic field 3 A m 3 A m characteristic of a typical IEC 61000 4 8 NOTE U is the a c mains voltage prior to application of the test level location in a typic
45. device data to the CareLink iPro server iPro2 CGM User Guide Glossary 92 Index Numerics 24 Hour HelpLine 9 accessing Logbook screen 46 accessing CareLink iPro 16 accessing patient records 42 activating iPro2 10 activity entering in Logbook 46 adding CareLink iPro users 17 59 Logbook entries 46 administrative user creating first 15 creating user accounts 17 59 deleting user accounts 60 modifying user accounts 59 tasks in CareLink iPro 59 alcohol wiping 27 area under the curve 53 assistance 9 attaching iPro2 to sensor 32 AUC 53 before connecting iPro2 32 BG meter patient instructions 31 BG meter readings excluding from calibration 47 blood glucose meter uploading data 45 blood glucose meter readings entering in CareLink iPro 46 blood glucose meter use patient instructions 31 blood glucose meters supported 6 briefing patient 30 browser required settings 22 supported browsers 7 C calibration improving 47 care and wearing instructions 31 CareLink iPro about uploading data 35 adding Logbook entries 46 changing password or user information 57 Data Table report 55 deleting user accounts 60 editing Logbook entries 47 editing patient information 57 entering blood glucose data 46 excluding BG meter readings 47 exporting data 55 meters supported 6 ongoing use administrator tasks 59 ongoing use user tasks 57 opening patient records 42 patient report settings 53 printing reports 50 removing Logbo
46. displayed 2 Click the Security tab The Security tab page is displayed 3 Select the Internet icon and click the Custom Level button The Security Settings page is displayed 4 Use the scroll bar on the right of the Settings box to scroll down to Active scripting 5 Underneath Active scripting select Enable 6 Click OK Enabling JavaScript in Firefox Take the following steps if you need to enable JavaScript or want to check the setting 1 From the Firefox menu options select Tools gt Options The Options page is displayed 2 Click Content 3 On the Content page make sure that Enable JavaScript is selected 4 Click OK iPro2 CGM User Guide One time CareLink iPro software and computer setup 22 Secure Sockets Layer SSL and encryption Secure Sockets Layer SSL refers to a security protocol designed to protect your Web browser sessions The system requires your browser to be enabled for SSL Version 3 It also requires support for 128 bit SSL encryption The minimum Internet browser version required by the system has 128 bit encryption built in So if you are receiving an error message about your browser configuration and it shows that you have an SSL setting of less than 128 bit key you probably need to upgrade to the latest version of your browser First take the following steps to check the SSL on the current version of your browser and make sure it is enabled Enabling SSL in Internet Explorer 1 From the Internet
47. e Logbook to exclude BG meter readings that do not accurately reflect the patient s blood glucose such as BG meter readings from someone other than the patient BG meter readings from a control solution BG meter readings that were taken before the patient changed the meter s time or date If the patient changed the time on the meter during the study first exclude all BG meter readings before the time change Then use information from the Patient Log Sheets to manually enter the BG meter readings at the correct times into the Logbook in CareLink iPro These bad BG meter readings can cause calibration errors which may result in gaps in the sensor plot on reports Excluding these bad BG meter readings will often eliminate data gaps Keep in mind that you need BG meter readings within 12 hours of each other in order to avoid data gaps iPro2 CGM User Guide CareLink iPro reports 50 e Modify a patient s Report Settings to change the target range for blood glucose the patient s meal periods or other settings About reports CareLink iPro reports show up to seven calendar days of study data The reports are created in PDF format so they can easily be stored electronically or printed The three main reports are e Daily Overlay one page provides an overlay of the sensor traces for each day on a single 24 hour graph so that you can look for trends or excursions that occur around the same time each day This report also provides da
48. e patient open the existing patient record Avoid creating multiple records for one patient as this will make the patient s data more difficult to find in the system Enter the identifying information for the patient The patient s name or patient ID that you enter will be displayed on reports Click Save when you are finished iPro2 CGM User Guide Uploading data to CareLinkiPro 42 You can modify the patient information later by clicking the Edit patient information link on the patient s record Uploading iPro2 data NOTE Always navigate using the buttons and links in CareLink iPro 1 Verify that the iPro2 you are about to upload is for the patient whose record you are viewing in CareLink iPro a Find the serial number on the Clinic Equipment Log and on the Patient Log Sheet These should match the serial number on the back of the iPro2 b On the Clinic Equipment Log indicate that the iPro2 has been returned Medtronic MiniMed REF MMT 7741 GT 5XXXXXXM 2X CAUTION Always make sure to verify that you are uploading the correct iPro2 2 Click the Upload iPro2 button 3 Follow the on screen instructions If you see a security warning asking if you want to continue this is asking if you trust that the content of this system is safe Your trust is based on the fact that Medtronic MiniMed has stated that is safe Select the check box Always trust content from this publisher and then click Yes 4 M
49. ecord that contains the study that needs to be moved 3 Find the study that you want to move in the list of studies for that patient 4 f you see a message that the study is incomplete enter the patient s BG meter readings by uploading the meter or using the Logbook 5 In the Other Options drop down list select Move this study 6 Follow the on screen instructions to find the correct patient and move the study to that patient s record When the move is complete the reports will be regenerated for the correct patient Modifying clinic information You may periodically need to edit the identifying information of the clinic that was entered when the clinic account was first created Some of this information appears on patient reports so it is important to keep the clinic information accurate 1 In the Clinic Settings tab click Clinic Information The clinic information is displayed If you do not see the Clinic Settings tab click the Home tab You should now see the Clinic Settings tab 2 Update the information as needed and click the Save button 3 When you are finished click Close clinic settings to return to the Patient List iPro2 CGM User Guide CareLink iPro ongoing use 58 Administrator tasks If you are administrative user you will need to create modify or delete CareLink iPro user accounts for your clinic as new employees join the clinic and others leave Creating user accounts 1 Get a list of names and
50. email addresses for staff members who need CareLink iPro user accounts In the Clinic Settings tab click Users The existing user accounts are displayed If you are not logged in as an Admin user you will not see the Users tab Click the Create new user button The Create New User screen appears Enter the required information about the user If you want this user to have permission to manage user accounts select the Administrative Privileges check box Important Always make sure that at least two people have administrative privileges If an Admin user leaves the clinic add a new one Click Save NOTE Usernames must be unique among all CareLink iPro clinics in the system not just your clinic If the username you entered is not available the system informs you that you must try a different username Make a note of the username and password so that you can provide them to the user He or she will need this information to sign in and select a new password Repeat this procedure for each user account that you need to create Modifying user accounts If you have administrative privileges you can modify a user account For example you may need to change a user password or grant or remove administrative privileges 1 In the Clinic Settings tab click Users The existing user accounts are displayed iPro2 CGM User Guide CareLink iPro ongoing use 59 2 Select the user account and click the Open user button The user ac
51. ence meter readings and corresponding sensor glucose concentrations The average difference between the sensor and the reference meter was 5 4 mg dL with a standard deviation of 44 2 mg dL Intra day correlation Correlation coefficients were calculated for each calendar day of sensor use The median correlation was 0 92 with 75 of the correlation values above 0 75 iPro2 CGM User Guide Sensor performance 77 Percent agreement The accuracy of the CGM system was evaluated by classifying sensor and reference meter readings into three categories across six concentration groupings 40 lt 60 mg dL gt 60 lt 80 mg dL gt 80 lt 180 mg dL gt 180 lt 300 mg dL gt 300 lt 350 mg dL gt 350 lt 400 mg dL The three categories are 1 percentage of CGM system readings within 20 of reference 2 percentage of CGM system readings within 30 of reference and 3 percentage of CGM system readings greater than 40 of reference Percent agreement for CGM system and reference meter 40 60 234 61 97 79 91 13 68 61 80 483 51 75 74 95 13 25 81 180 2267 55 05 72 47 16 41 181 300 917 60 96 79 93 10 58 301 350 82 50 00 68 29 15 85 351 400 38 50 00 68 42 23 68 Overall 4021 56 25 74 78 14 60 For the 40 60 and the 61 80 mg dL groups the difference is presented as the absolute difference in mg dL between the CGM system sensor and the reference Overall nothing remarkable was observed across all cells
52. ent data if necessary Opening the Logbook If you have just finished uploading the patient s meter click Continue to open the Logbook You can also open the Logbook by clicking the Open Logbook button found on the patient record screen Adding Logbook entries CareLink iPro calibrates the sensor glucose data using the patient s BG meter readings that are uploaded or entered manually If you cannot upload data from the patient s meter then you must enter BG meter readings manually in the Logbook iPro2 CGM User Guide Uploading data to CareLinkiPro 46 Click the Add button A small window appears where you can make a Logbook entry Enter the date and time If the entry is a BG meter reading enter the BG value If the entry is an event select the check box for the event If the patient recorded more than one entry at the same time such as a meal and a BG meter reading you must enter them both in one entry NOTE If a daylight saving time change occurred during the study or after the study but before you are entering the data enter all log sheet events that occurred before the time change according to the new time Click Enter The information goes into the Logbook but a new empty data entry window stays open and is ready for the next entry When you are finished adding Logbook entries click the X in the upper right corner of the data entry window to close it If you are finished using the Logbook click Continue t
53. epublika Medtronic Czechia s r o Tel 420 233 059 401 Non stop help line 420 233 059 059 Contents Chapter 1 1 Introduction 2 iPro2 system 4 User safety 4 Indications for use 4 Contraindications 4 Warnings 5 Precautions 6 Meters supported by CareLink iPro for uploading 7 Computer system requirements 7 Compliance information 9 Interference from wireless devices 9 Assistance Chapter 2 10 One time device setup 11 One time iPro2 activation 13 Key notes about iPro2 Chapter 3 14 One time CareLink iPro software and computer setup 15 Register clinic and create administrative user 16 Signin 16 Create user accounts 17 Set clinic report settings 18 General Report Settings 18 Overlay by Meal Report Settings 19 Set up computers for uploading 21 Required settings for Windows Vista Windows 7 and Windows 8 users 22 Required Internet browser settings 22 Enabling JavaScript 22 Enabling JavaScript in Internet Explorer iPro2 CGM User Guide Contents v Chapter 4 Chapter 5 Chapter 6 22 23 23 23 24 25 26 27 28 29 29 30 31 31 31 31 32 32 35 36 36 36 37 37 42 43 45 46 46 46 47 47 48 48 49 50 50 51 51 53 53 54 Enabling JavaScript in Firefox Secure Sockets Layer SSL and encryption Enabling SSL in Internet Explorer Enabling SSL in Firefox Download and print resources Patient setup Preparing for study Wiping the iPro2 with alcohol before a patient study Tips for a successful patient
54. equential punitive or special damages of any nature or kind caused by or arising out of a defect in the product All other warranties expressed or implied are excluded and specifically disclaimed including but not limited to any warranty of merchantability or fitness for a particular purpose iPro2 CGM User Guide Specifications and notices 88 Icon table Description Icon Follow instructions for use Attention Read all warnings and precautions in instructions for use Stand by power Charging uploading status Date of manufacture year month Manufacturer EZOGPE e Batch code Catalogue number Device serial number Configuration Storage humidity range Storage temperature range Fragile product Ingress protection safety rating An object one millimeter in diameter cannot penetrate the device and cause harm to the user property or the environment This device can withstand immersion under water for 30 minutes at a depth of 8 feet 2 4 meters Type BF equipment Protection from electrical shock Recycle One per container package Three per container package Keep dry iPro2 CGM User Guide Specifications and notices 89 MEDICAL EQUIPMENT WITH RESPECT TO ELECTRICAL SHOCK FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH UL 60601 1 CAN CSA C22 2 No 601 and IEC 60601 1 1 oil 4 US 46FY
55. erate reports from a study e Reports show up to seven calendar days of study data e The reports are created in PDF format so they can easily be stored electronically or printed iPro2 CGM User Guide CareLink iPro reports 49 Viewing and printing patient reports After uploading and entering all of a patient s study data into CareLink iPro you have two options for viewing the patient s reports View and print the reports individually Print all reports If you are not already viewing the patient record go to the Home tab and use the Search box to find the patient record If you need more instructions on how to find a patient record see Opening the patient record on page 42 On the patient record screen you can find the dates for all of the studies conducted for this patient The most recent study is displayed first You may need to scroll down to find older studies When you find the study you want click the name of the report you want to view or click Print all to print all three of the main reports If you click on a single report a new window or tab opens in your browser to display the report If you click Print all a new window or tab opens in your browser with all of the reports in a single PDF document To print use the print functions that are set up on the computer For example you may need to click a printer icon or you may need to select File gt Print Tips for successful report generation Use th
56. es for the computers in the office you will not be able to complete this task Ask a user with Windows administrative privileges such as your network administrator to sign in to each computer to allow the installation of required software components e You must do this for each computer that may be used to upload sensor data from an iPro2 using the Dock e If the computer is running Windows Vista Windows 7 or Windows 8 see Required settings for Windows Vista Windows 7 and Windows 8 users on page 21 before completing this procedure iPro2 CGM User Guide One time CareLink iPro software and computer setup 19 CAUTION Do not connect the Dock to the computer until specifically told to do so in this procedure If you connect the Dock before the iPro2 Dock driver is installed you may see the Windows Found New Hardware Wizard Close the wizard screen or click Cancel and do not follow the instructions in the Wizard It may prevent the iPro2 Dock driver from installing properly 1 Sign in to CareLink iPro 2 On the Home screen click Patient Sample M in the Patient List If you already have a list of patients type Sample Patient in the Search box to find the sample patient in the Patient List and click on it to select it 3 Click Open patient A sample patient record is displayed 4 Click the Upload iPro2 button If you see a message asking if you are sure you want to upload another study for the patient click Yes If y
57. evice setup 12 7 Leave the iPro2 on the Dock to continue charging During charging the white Dock power light will be on and the green charging light will flash 8 Allow up to eight 8 hours for the iPro2 to fully charge Once the iPro2 is charged the green charging light on the Dock will stop flashing and will remain on This means that the iPro2 is fully charged When charged regularly after each sensor use the iPro2 will become fully charged in only about 30 minutes Key notes about iPro2 e The reset button on the Dock is used to wake up or activate the iPro2 because it is shipped in a special sleep mode This is a one time task In the future doing this will erase all sensor data that is on the iPro2 e Never connect an iPro2 to any device other than the Dock sensor or cleaning plug For example never connect the iPro2 to the charger for the MiniLink shown here because any patient data on the iPro2 could be erased iPro2 CGM User Guide One time device setup 13 One time CareLink iPro software and computer setup register clinic create Admin user 3 create user accounts set up each computer 4 set clinic report settings for uploading m a a Key Notes Do not connect the Dock to the computer until specifically told to do so in this procedure If you connect the Dock before the iPro2 Dock driver is installed it may prevent the iPro2 Dock driver from installing properly e You may
58. facturer may not provide drivers for all operating systems that CareLink iPro supports such as Windows 8 Windows 7 and Windows Vista 64 bit CareLink iPro does not support USB uploads for all meters See Meters supported by CareLink iPro for uploading on page 6 for details Computers running CareLink iPro must also be compliant with IEC 60950 1 or an equivalent safety standard Compliance information The iPro2 and Dock comply with the United States Federal Communications Commission FCC and international standards for Electromagnetic Compatibility For the specific regulations and test results for your area please contact your local representative iPro2 CGM User Guide Introduction 7 These devices comply with Part 15 of the FCC Rules Operation is subject to the following two conditions 1 These devices may not cause harmful interference 2 These devices must accept any interference received including interference that may cause undesirable operation These standards are designed to provide reasonable protection against excessive radio frequency interference and prevent undesirable operation of the device from unwanted electromagnetic interference iPro2 CGM User Guide Introduction 8 Interference from wireless devices Common wireless consumer devices such as cellular mobile phones or cordless phones may disrupt communication during iPro2 uploads to the computer It is likely that other wireless devices using similar
59. frequency ranges will have a similar effect This interference however will not cause any incorrect data to be sent and will not cause any harm to your iPro2 system To reduce the likelihood of data communication errors you should relocate either the wireless device or the iPro2 system devices Testing conducted with several different cellular phones suggests that interference will not be a problem if the phone is at least 12 inches 30 centimeters from the iPro2 system devices Assistance If you need help contact one of the following resources 24 Hour HelpLine Advanced Software Support 800 646 4633 Monday through Friday 5 a m to 5 p m PST 818 576 5555 Medtronic Diabetes Web site www medtronicdiabetes com iPro2 CGM User Guide Introduction 9 One time device setup activate iPro2 EEE R Key Notes The reset button on the Dock is used to wake up or activate the iPro2 because it is shipped in a special sleep mode This is a one time task In the future doing this will erase all sensor data that is on the iPro2 Never connect an iPro2 to any device other than the Dock sensor or cleaning plug For cleaning use only the cleaning plug iPro2 CGM User Guide One time device setup 10 One time iPro2 activation The iPro2 is shipped in a special sleep mode to protect its battery You need to wake it up by following this one time procedure This should be done a minimum of eight
60. g clinic information Administrator tasks Creating user accounts Modifying user accounts Deleting user accounts System maintenance Cleaning the iPro2 Cleaning the Dock Components that cannot be cleaned Charging the iPro2 between studies Storage and organization tips Troubleshooting Troubleshooting reference CareLink iPro messages Checking the iPro2 connector pins Dock lights quick reference Resetting the iPro2 Sensor performance In Vivo performance Numerical agreement Intra day correlation Percent agreement Clarke Error Grid analysis Linear regression Precision Interference Limitations Use in special patient groups Specifications and notices iPro2 system specifications Guidance and manufacturer s declaration iPro2 CGM User Guide Contents vii Glossary Index 88 89 91 93 Warranty Icon table iPro2 CGM User Guide Contents viii Introduction user Safety assistance IEEE KS Welcome to iPro2 Continuous Glucose Monitoring CGM Thank you for your trust in Medtronic products and services We hope you will find iPro2 to be the simplest and most convenient CGM product that you have ever used e This User Guide provides the information that you need for setting up and using the iPro2 CGM system including CareLink iPro Therapy Management Software for Diabetes e You will find a page like this at the beginning of each chapter This page gives you a basic overview of that chapter and the steps
61. g light and the red warning light indicate the status of the iPro2 If the green charging light is on the iPro2 is 100 ready to use In this User Guide you will see the three Dock lights described using the following conventions Each light is always either off on or flashing poa Red Warning Light Green Charging Light White Dock Power Light off iPro2 CGM User Guide Introduction 2 iPro 2 Dock USB cable refer to MMT 7747 if re ordering The small end of the Universal Serial Bus USB cable connects to the Dock The other end of the cable connects to a USB port on a computer so that you can upload data into CareLink iPro and charge the iPro2 You can also connect the USB cable to a wall powered adapter Wall powered adapter refer to MMT 7747 if re ordering The wall powered adapter lets you charge the iPro2 by connecting the Dock to a regular electrical socket instead of a computer Three 3 iPro 2 Cleaning Plugs MMT 7744 cleaning plug The cleaning plugs provide a watertight seal to protect the connector pins on the iPro2 Always use a cleaning plug when cleaning and disinfecting the iPro2 Do not clean the o rings on the cleaning plug as this can damage the o rings The cleaning plug can be used to clean the iPro2 30 times Keep track of cleaning plug uses and discard the cleaning plug after 30 uses If you continue to use the cleaning plug beyond 30 times the iPro2 connector pins could be damaged because t
62. ge during the upload process Device not found in iPro2 Docking Station Please connect iPro2 Recorder A Dock is not connected to the computer it is not securely connected or it has insufficient power from the computer to operate The iPro2 is not in the Dock or it is not properly connected This message may also appear if the iPro2 connector pins are damaged or corroded or if there is moisture in the connector opening If the white Dock power light is on then the USB cable may not be securely connected Make sure that the cable is plugged in all the way to the Dock and to the computer If the white Dock power light is not on try connecting the Dock to a different USB port on the computer Wait for all three lights to flash followed by a solid white light If the Dock is connected to the computer but none of the lights turn on there may be other USB devices connected that are using up power Disconnect other devices Do not connect more than one Dock at a time to a computer If you are using a USB hub it may not be receiving enough power for the Dock to operate Try using a powered hub which has its own electrical plug that connects to an electrical socket If your iPro2 is connected try disconnecting and reconnecting the iPro2 to the Dock If the white Dock power light is on but the three lights do not flash when you connect the iPro2 the iPro2 may be damaged Check the iPro2 connector pins for moisture d
63. gh BG meter readings to fully calibrate the sensor data This can cause gaps in data on the patient s reports CareLink iPro needs at least one BG meter reading within an expected range every 12 hours Erroneous BG meter readings may be ignored by CareLink iPro and may stop the sensor plot until the next good BG meter reading e Make sure that your patient tests blood glucose at least one hour after the iPro2 is connected to the sensor The iPro2 takes one hour to start up a sensor If the patient does the first BG meter reading too soon sensor data will not be available for calibration Therefore the sensor trace in the reports will begin at the time of the next BG meter reading This will be apparent in CareLink reports because the data will begin later than you expect e Make sure that the patient does another BG meter reading two hours after the first one This BG meter reading is a backup in case the first BG meter reading was a few minutes too early e Mid study upload Uploading sensor data from an iPro2 clears the data from the iPro2 The first upload will be shown as its own study in CareLink iPro When the iPro2 is reconnected to the sensor it will begin the one hour start up again and start a new study assuming that it also has enough charge to start a new study You cannot combine two separate uploads into one set of reports in CareLink iPro iPro2 CGM User Guide Patient setup 28 Do not change the sensor during the study The iPro
64. greater than 106 F 41 C the temperature of the iPro2 may exceed 109 F 43 C iPro2 relative humidity 5 to 95 with no condensation Dock temperature 23 to 113 F 5 to 45 C Dock relative humidity 5 to 95 with no condensation Storage Conditions iPro2 temperature 13 to 131 F 25 to 55 C iPro2 relative humidity 10 to 100 with no condensation Dock temperature 13 to 131 F 25 to 55 C Dock relative humidity 10 to 100 with no condensation iPro2 Battery Life 7 days of continuous glucose monitoring CGM immediately following a full charge plus 10 days of additional battery life immediately following a CGM study Any data on the device will be lost when the battery loses its charge iPro2 Dimensions and Weight Width 1 4 inches 3 5 centimeters Length 1 1 inches 2 8 centimeters Height 0 4 inches 0 9 centimeters Weight 0 2 ounces 5 7 grams Dock Dimensions and Weight Width 2 inches 5 1 centimeters Length 2 5 inches 6 4 centimeters Height 1 1 inches 2 8 centimeters Weight 0 8 ounces 22 7 grams iPro2 CGM User Guide Specifications and notices 82 The iPro2 is an internally powered device The mode of operation is continuous The iPro2 is not suitable for use in the presence of a flammable anaesthetic mixture with air or with oxygen or nitrous oxide All components of the iPro2 CGM system are suitable for use in a clinical environment
65. he cleaning plug cannot continue to provide a watertight seal Keep only one unwrapped cleaning plug at hand so that you can keep track of its use and will know when to unwrap a new cleaning plug To order more cleaning plugs contact your local representative or call Medtronic Diabetes at 800 843 6687 You will also need the following Sen serter MMT 7500 Glucose sensor MMT 7002 or MMT 7003 A computer with Internet access to CareLink iPro MMT 7340 http www carelinkipro com Patient Log Sheet Patient Consent Form Patient Instructions Sheet Clinic Equipment Log Sheet Clinic Checklist for patient setup and for uploading iPro2 data and printing reports Occlusive adhesive dressing iPro2 CGM User Guide Introduction 3 User safety This section includes important safety information such as indications contraindications warnings and precautions Indications for use This iPro2 digital recorder is intended to continuously record interstitial glucose levels in persons with diabetes mellitus This information is intended to supplement not replace blood glucose information obtained using standard home glucose monitoring devices The information collected by the iPro2 digital recorder may be uploaded to a computer with Internet access and reviewed by healthcare professionals The information may allow identification of patterns of glucose level excursions above and below a desired range facilitating therapy adjustme
66. he patient but not apply them to any studies yet click No iPro2 CGM User Guide CareLink iPro reports 54 If you want to apply the new Report Settings for the patient to one or more studies find the study on the patient record screen and select Regenerate reports from the Other Options drop down list The reports are re generated using the new Reports Settings Generating a Data Table report If necessary you can generate a Data Table report about 15 pages or more This report lets you view detailed sensor glucose readings and events that are recorded in the Logbook The Data Table is used by Medtronic employees for troubleshooting purposes Most of the time you do not need it in order to understand a study 1 In the patient record screen select Generate Data Table from the Other Options drop down list After a few moments a new Data Table PDF link appears 2 Click the link to view the report The report opens in a new browser window or tab Or click Print to print the report without viewing it first Exporting data to CSV file If necessary you can export report data as a character separated values CSV file for further analysis A CSV export is raw data typically for clinical study use Additional information in the data is used by Medtronic employees for troubleshooting purposes Most of the time you do not need it in order to understand a study 1 In the patient record screen select Export data from the Other Options dr
67. hours before your first iPro2 patient setup CAUTION Do not perform this procedure if you already have sensor data on the iPro2 If you press the reset button while the iPro2 is connected to the Dock all sensor data on the iPro2 will be erased This procedure is only for activating the iPro2 for the first time 1 Connect the small end of the USB cable to the Dock 3 Connect the wall powered adapter into an electrical socket The three lights on the Dock will flash once and then the white Dock power light will remain on indicating that the Dock is plugged in iPro2 CGM User Guide One time device setup 11 4 Place the iPro2 into the Dock The green charging light will start flashing NOTE The red warning light may turn on if you do not immediately complete the next steps This is normal because the iPro2 has not been activated You can continue to follow these instructions even if you see the red warning light 5 Find the small hole on the back of the Dock next to the USB cable This is the reset button 6 Insert the end of a small paper clip into the hole about 1 8 inch 0 30 cm Push the reset button once and release The white Dock power light will flash fo After a few seconds the green light on the iPro2 will flash FF Important Do not apply excessive pressure or the reset button may be damaged The iPro2 is now activated It will never return to sleep mode iPro2 CGM User Guide One time d
68. ily statistical information including an Excursion Summary of highs and lows and Duration Distribution pie charts The Duration Distribution charts show what percent of each day the patient spent above below and within the target range e Overlay by Meal two pages provides an overlay of the sensor traces from each day of the study broken down into meal and overnight periods The meal overlay graphs are only created if meal events are entered into the CareLink iPro Logbook The patient s Report Settings if different from the clinic Report Settings determine what the periods are The sensor traces for each day are overlaid so that you can look for trends at certain times related to meal or overnight periods This report lines up glucose sensor traces before and after each meal and is especially useful if patients eat meals at varying times each day e Daily Summary two pages provides a summary of each full or partial 24 hour period of the study including both the sensor trace and events such as meals medication and exercise Optimal accuracy CareLink iPro automatically performs certain checks for optimal accuracy of the data in a study These checks are designed to help you become aware of any data that may be less than optimal for making therapy decisions The system evaluates the accuracy of the data on a calendar day basis from midnight to midnight for each day that sensor glucose values are recorded There are three measurement
69. inaccurate glucose readings In vitro testing has indicated that the monitor may record inaccurate glucose readings during exposure to electromagnetic fields of 3 V M or stronger Therefore the use of the CGM system in close proximity to strong electromagnetic sources such as medical imaging equipment television transmitters high voltage power lines and high power radio transmitters is not recommended iPro2 CGM User Guide Sensor performance 80 Use in special patient groups The device has been clinically tested primarily in adult caucasian persons with Type 1 diabetes This device has not been clinically tested in children Because of variations in size and amount of body fat performance may be different in children than in adults Although the system has not been studied in other diabetic patient populations similar results are expected iPro2 CGM User Guide Sensor performance 81 Specifications and notices iPro2 system specifications Atmospheric pressure range iPro2 57 6kPa 106kPa 16 000 to 1 300 feet 4 880 to 400 meters elevation Dock 62kPa 106kPa 13 000 to 1 300 feet 3 965 to 400 meters elevation Applied Parts iPro2 MMT 7741 Sensor MMT 7002 or MMT 7003 Biocompatibility iPro2 Complies with ISO 10993 1 for long term body contact Operating Conditions iPro2 temperature 23 to 113 F 5 to 45 C Caution When the iPro2 is connected to the Dock in air temperatures
70. lease The white Dock power light will flash 0 After a few seconds the green light on the iPro2 will flash Co Important Do not apply excessive pressure or the reset button may be damaged iPro2 CGM User Guide Troubleshooting 75 5 Wait for the Dock to show a solid green charging light This indicates that the data has been cleared and the iPro2 is fully charged and ready for the next patient study iPro2 CGM User Guide Troubleshooting 76 Sensor performance In Vivo performance In this multicenter clinical trial a total of 62 subjects used the CGM system on average for a period of 18 6 days An average of 6 7 sensors were used by each subject Accuracy of the CGM system was evaluated using the Accu chek glucometer reference meter BGs Subjects took frequent blood glucose meter readings using a commercially available home glucose meter CGM system performance was assessed by comparing the glucose meter readings to the glucose values calculated by the CGM system The data collected during the study was used to calculate intra day correlation the average numerical difference between the sensor and meter readings and the categorical agreement between the sensor and meter 1 Study GS004 1997 A Multi center Clinical Evaluation of the Continuous Glucose Monitoring System CGMS Numerical agreement Numerical agreement was assessed by averaging the individual differences between the blood glucose meter readings refer
71. limit The differences are summed and the sum total is divided by the total number of sensor glucose values that exist for the day e AUC Below Limit this statistic provides a relative indication of the overall extent and duration of low glucose excursions over the entire day The calculation is dependent on the patient Glucose Target Range Low setting Each individual sensor glucose value that exceeds the limit is subtracted from the Low limit value The differences are summed and the sum total is divided by the total number of sensor glucose values that exist for the day Patient Report Settings When you first add a patient into CareLink iPro the patient s Report Settings are set based on the current Clinic Report Settings that are defined on the Clinic Settings tab The Clinic Report Settings are like a template for creating the Report Settings for each new patient After a patient record has been created you can change the Report Settings for that patient s reports For example the patient s meal periods may not match the default meal periods which were defined for your clinic in the Clinic Report Settings Or the target glucose range for the patient may be different from the default range set in the Clinic Report Settings In these cases you can modify a patient s report settings manually e If you change the Patient Report Settings before generating reports future reports will be generated based on the changes you made e If y
72. load the iPro2 into that patient s record in CareLink iPro CareLink iPro clears the data off of the iPro2 as part of the upload process You must then wait for the green charging light on the Dock to turn solid before the iPro2 is ready to use for the next patient If you are unable to identify which patient s data is still on the iPro2 or if you are unable to upload the iPro2 successfully you may need to reset the iPro2 For instructions see Resetting the iPro2 on page 75 If the sensor pulled out make sure that the sensor is fully inserted and properly taped to the skin for future studies If you did not see an error message in CareLink iPro during the uploading process it could be that there are not enough BG meter readings for calibration after a certain point in the study Make sure that you have entered all of the patient s BG meter readings into CareLink iPro CareLink iPro needs good BG meter readings in order to calibrate sensor data Less than three BG meter readings per day or more than 12 hours between BG meter readings can result in data gaps If you saw a CareLink iPro error message see the troubleshooting steps for that error message in this section iPro2 CGM User Guide Troubleshooting 67 There are gaps in the sensor data in the reports A common cause of data gaps is partial sensor pullout There can also be calibration problems due to an insufficient number of BG meter readings readi
73. meter into CareLink iPro Mean Absolute Difference MAD Represents the level of accuracy in calibration of the sensor to BG meter readings The lower this number the greater the calibration accuracy MAD is calculated by taking the difference between closely occurring pairs of sensor glucose and BG meter readings dividing by the BG meter reading and then averaging across all pairs Mean Absolute Difference MAD Represents the level of accuracy in calibration of the sensor to BG meter readings The lower this number the greater the calibration accuracy MAD is calculated by taking the difference between closely occurring pairs of sensor glucose and BG meter readings and then averaging across all pairs Meter A medical device for determining the approximate concentration of glucose in the blood A small drop of blood is placed on a disposable test strip which the meter reads and uses to calculate the blood glucose level The meter then displays the level in mg dL or mmol L Sen serter The Sen serter is indicated as an aid for insertion of the Medtronic Diabetes glucose sensor iPro2 CGM User Guide Glossary 91 Study The period of time that a patient wears a glucose sensor and iPro2 This word also refers to an upload of glucose sensor data from an iPro2 into CareLink iPro along with any meter upload and Logbook entries for that iPro2 upload Each study has its own set of reports Upload The process of transferring diabetes
74. ngs that are more than 12 hours apart or readings that are out of the expected range Make sure that you have entered all of the patient s BG meter readings into CareLink iPro CareLink iPro needs good BG meter readings in order to calibrate and report sensor data Less than three per day can result in data gaps Also check the sensor trace on reports to see if there are BG meter readings not used for calibration Bad BG meter readings are identified as calibration errors These BG meter readings are not used for calibration and cause the sensor plot to stop The sensor plot starts again at a good BG meter reading You can eliminate some data gaps by excluding bad BG meter readings using the Exclude feature in the Logbook Some sensor pullouts can be avoided by applying an adhesive dressing over the iPro2 and sensor Always advise patients to test their blood glucose at least four times a day uploaded the wrong meter for a patient Can fix this In the Logbook screen check the Exclude check box to exclude all of the BG meter readings that came from the wrong meter The readings from the wrong meter will still be in the Logbook but they will not affect sensor calibration or reports If you find the right meter or log sheets for the patient you can manually enter the BG meter readings from the right meter Also you can still upload the meter to the correct patient study uploaded the wrong iPro2 for a patient
75. nts which may minimize these excursions This iPro2 system e is intended for prescription use only e does not allow data to be made available directly to patients in real time e provides data that will be available for review by physicians after the recording interval 72 hours e is intended for occasional rather than everyday use e is to be used only as a supplement to and not a replacement for standard invasive measurement Contraindications None known Warnings e This product contains small parts and may pose a choking hazard for young children e The glucose sensor should be removed if redness bleeding pain tenderness irritation or inflammation develops at the sensor insertion site or if the patient experiences unexplained fever iPro2 CGM User Guide Introduction 4 An optional occlusive adhesive dressing should be removed if irritation or reaction to the tape develops e The glucose sensor may create special needs regarding your patients medical conditions or medications Healthcare professionals should discuss this with their patients before they use the glucose sensor e Do not modify this product as modification could result in a safety hazard Precautions e Do not expose the iPro2 to Magnetic Resonance Imaging MRI equipment x ray equipment Computed Tomography CT scanners Intensity Modulated Radiation Therapy IMRT or other devices that generate strong magnetic fields or ionizing radiation
76. o After you upload data if the green charging light continues to flash the iPro2 is still charging and is not ready to begin a new patient study The white Dock power light and green charging light are on All previous data has been cleared from the iPro2 The iPro2 is fully charged and ready for the next patient study The white Dock power light flashed five times and the green charging light is flashing continuously The white Dock power light will flash five times after you press the reset button The green charging light will continue to flash as the iPro2 charges When the iPro2 is fully charged the green charging light will stop flashing and remain on The white Dock power light and the red warning light are on There may be a problem with the iPro2 See Troubleshooting reference on page 66 for details iPro2 CGM User Guide Troubleshooting 74 Resetting the iPro2 CAUTION This procedure erases all patient data from the iPro2 Do not perform these steps unless you have already uploaded the last patient study or you are prepared to erase any data that may be on the iPro2 1 Connect the Dock to power and make sure that the white Dock power light is on 2 Place the iPro2 into the Dock 3 Find the small hole on the back of the Dock next to the USB cable 4 Insert the end of a small paper clip into the hole about 1 8 inch 0 30 cm Push the reset button once and re
77. o return to the patient s main record screen NOTE Only BG meter readings between 40 and 400 mg dL 2 2 and 22 2 mmol L will be used for calibration Excluding BG meter readings You can tell CareLink iPro to exclude a BG meter reading so that it is not used to calibrate the sensor glucose data For example if the patient allowed a different person to use the meter or if a control solution was used but the BG meter reading was not marked as a control reading in the meter you would not want these BG meter readings to be used for sensor calibration In the patient s Logbook screen click the Exclude check box for each BG entry that you want to exclude from the calibration If you are finished using the Logbook click Continue to return to the patient s main record screen The reports are regenerated automatically When you view the patient s reports the BG meter readings that you excluded will not be shown and they will not affect the sensor information in the reports Editing Logbook entries You can edit Logbook entries that have been entered manually Events that were uploaded from a meter cannot be edited You can only exclude them from calibration In the patient s Logbook screen click on a Logbook entry to select it and then click the Edit button The Logbook entry opens in a small window iPro2 CGM User Guide Uploading data to CareLink iPro 47 2 Edit the information as needed and click Enter 3
78. ock Disconnect and reconnect the iPro2 to the Dock The iPro2 is connected to the Dock and the red warning light is on This could mean that the iPro2 is not properly connected to the Dock or needs to be reset It also could mean that there is damage to the iPro2 battery circuitry or connector pins The iPro2 may need to be replaced Disconnect the iPro2 and check the connector pins for damage corrosion or moisture For assistance in locating the connector pins see Checking the iPro2 connector pins on page 73 After you confirm that the pins are not damaged or corroded reconnect the iPro2 to the Dock If another Dock is available try connecting the iPro2 to the other Dock If there is sensor data on the iPro2 upload the sensor data using CareLink iPro If the red warning light turns on again perform a reset as described in Resetting the iPro2 on page 75 Allow the iPro2 to charge for 20 minutes Please note that by performing a reset all iPro2 sensor data will be erased If the red warning light continues to turn on or if the iPro2 pins are damaged or corroded contact the 24 Hour HelpLine It may be time to replace the iPro2 iPro2 CGM User Guide Troubleshooting 69 CareLink iPro messages CareLink iPro displayed this message during the upload process iPro2 Docking Station not found Please connect the iPro2 Docking Station to the computer CareLink iPro displayed this messa
79. ok entries 48 reports 49 51 restoring default patient report settings 54 signingin 16 software setup 14 sorting Logbook entries 48 tips for successful reports 50 iPro2 CGM User Guide Index 93 uploading data 43 uploading meter data 45 viewing reports 50 charging iPro2 63 cleaning cleaning plug 62 Dock 62 iPro2 37 62 USB cable 62 wall powered adapter 62 cleaning iPro2 about 62 before patient study 27 cleaning plug about 2 clearing iPro2 data 75 clinic registration 15 clinic report settings 17 common tasks in CareLink iPro administrator tasks 59 regular user tasks 57 compliance information 7 computer system requirements 7 connecting iPro2 preparing 32 connecting iPro2 to sensor 32 contraindications 4 correcting Logbook entries 47 creating CSV file 55 Data Table report 55 user accounts 16 17 59 CSV file export 55 D Daily Overlay report about 51 Daily Summary report about 51 daily use common tasks in CareLink iPro 57 managing users in CareLink iPro 59 data exporting to CSV 55 log sheets entering 46 uploading blood glucose meter 45 uploading iPro2 43 Data Table report generating 55 default report settings 17 deleting user accounts 60 deleting Logbook entries 48 device setup first time 10 devices that connect to iPro2 13 disconnecting iPro2 from patient 36 disinfecting iPro2 37 62 Dock about 2 cleaning 62 lights quick reference 74 watertightness 62 Dock lights about 2 editing Care
80. olution for each use NOTE Disinfecting efficacy testing and robustness testing were conducted on the iPro2 using Clorox Regular Bleach EPA registration number 5813 50 distributed by The Clorox Company Robustness testing for the iPro2 included a contact time of 30 minutes per cycle for 61 cycles which is equivalent to cleaning every three days for six months With cleaning plug still attached soak the iPro2 in the bleach solution for 30 minutes iPro2 CGM User Guide Uploading data to CareLink iPro 40 NOTE Be sure to set a timer to remove the iPro2 from the bleach solution at 30 minutes 16 Important If you saw any body fluid inside the connector opening on earlier inspection you must now discard the iPro2 with cleaning plug still attached according to local regulations for battery disposal non incineration 17 Disconnect the cleaning plug from the iPro2 by gently squeezing the arms of the cleaning plug iPro2 CGM User Guide Uploading data to CareLink iPro 41 18 19 20 Inspect the housing of the iPro2 for any signs of cracking flaking or damage If you see any of these signs you must now discard the disinfected iPro2 according to local regulations for battery disposal non incineration WARNING Cracking flaking or damage of the housing are signs of deterioration and the performance of the device may be compromised This may affect the ability to properly clean and disinfect the iPro2 If these
81. on during the study Do not change any settings on the meter during the study even if a daylight saving time change occurs Take at least four blood glucose BG meter readings per day such as before each meal and before bed iPro2 CGM User Guide Patient setup 30 e Only BG values between 40 and 400 mg dL 2 2 and 22 2 mmol L will be used for calibration If a meter reading is outside of this range it does not count and another BG meter reading will be needed when the patient s blood glucose is within the range CAUTION The patient must return the iPro2 to the clinic within 10 days of the end of the study What to do while briefing the patient 1 Give the patient the materials they need including at least one Patient Log Sheet and a Patient Instructions Sheet 2 On the Patient Log Sheet write the patient s name iPro2 serial number meter brand meter ID and the times for the first two BG meter readings 3 Make sure that the patient s blood glucose meter has a good battery that will last for the entire length of the study 4 Check the date and time on the blood glucose meter Meter use Instruct the patient that BG meter readings are required to calibrate the sensor data and that for successful study data the patient must follow these guidelines for meter use First day The patient must do three blood glucose BG meter readings on the first day at these times At least one hour after you connect the iPro
82. op down list After a few moments a dialog box opens allowing you to save the file on the computer 2 Save the file on your computer or network You can now open the file directly for example in Microsoft Excel or Access iPro2 CGM User Guide CareLink iPro reports 55 CareLink iPro ongoing use administrator tasks user tasks Key Notes Click the Resources hyperlink in CareLink iPro to print the newest log sheets and other forms e Only administrative users can add modify and delete CareLink iPro user accounts Always make sure more than one person has administrative privileges e Any CareLink iPro user can edit patient information when needed iPro2 CGM User Guide CareLink iPro ongoing use 56 User tasks Printing more log sheets and other forms Your original iPro2 shipment may have included samples of Patient Log Sheets Clinic Equipment Logs and other documents that your clinic wants to use regularly You can easily download and print more of these documents 1 Click the Resources link at the bottom of the CareLink iPro screen 2 Find the document that you want and open it 3 Select the print option in your browser Changing your password or other user information As a CareLink iPro user you can change your own password email address and other information in your user account 1 Sign in to CareLink iPro 2 Click the My Info link The My Info screen is displayed 3 If you want to
83. or e Sharps container e iPro2 charged and disinfected The green charging light on the Dock must be on not flashing before you remove the iPro2 from the Dock e Patient Log Sheets e Patient Consent Form e Patient Instructions e Clinic Equipment Log e Occlusive adhesive dressing e Optional Clinic Checklist NOTE Use universal precautions when handling the sensor and iPro2 iPro2 CGM User Guide Patient setup 26 Wiping the iPro2 with alcohol before a patient study The iPro2 is intended for multiple patient use Follow this procedure before each patient use 1 While wearing gloves attach the cleaning plug to the iPro2 to make sure that fluids do not contact the iPro2 s connector opening Fluids can cause the connector pins to corrode and affect the iPro2 s performance CAUTION Do not twist the cleaning plug while it is attached to the iPro2 This will damage the iPro2 Wipe the iPro2 with an alcohol swab or rinse with alcohol 3 Disconnect the cleaning plug from the iPro2 by gently squeezing the arms of the cleaning plug CAUTION The o rings on the cleaning plug have lubricant to help make a watertight seal with the iPro2 This lubricant may wear off after approximately 30 uses At that time the cleaning plug must be discarded Keep only one unwrapped cleaning plug at hand so that you can keep track of its use and will know when to unwrap a new cleaning plug iPro2 CGM U
84. ou change the Report Settings after generating reports you must choose whether you want to apply the new settings to the most recent reports You can also apply the new settings to older studies Existing study reports will not be updated automatically based on the new settings After viewing the first reports you generate for a patient you may decide to modify the Patient Report Settings and then generate the reports again based on the new settings iPro2 CGM User Guide CareLink iPro reports 53 Modifying Patient Report Settings 1 Click the Edit link in the Patient Report Settings section of the patient record screen The patient s General Report Settings and Overlay by Meal Report Settings are displayed Change the settings as needed For more information about the General Report Settings and Overlay by Meal Report Settings see General Report Settings on page 18 or Overlay by Meal Report Settings on page 18 Click Save A small window appears asking if you want to apply these report settings to the most recent set of reports To apply the settings to the most recent reports click Yes The report settings screen closes and the patient record screen appears where you can view and print the updated reports The new Report Settings have been applied to the most recent study You can then click any of the reports for the most recent study to view and print one of them or click Print All to print all of the reports To save the
85. ou see a message at any time that you do not have permission to install software contact your network administrator 5 If the computer does not have the necessary version of Java installed a screen prompting you to install Java is displayed a Click Download and Install the Java Plug in to continue If you are using Firefox the link will navigate to the Sun Java web site b Follow the on screen instructions to install Java c If you see any security questions in the information bar above the Medtronic logo or security pop ups click Allow or Continue Also check the task bar at the bottom of your screen for new items The Java installation pop up may sometimes be hidden behind your current browser window NOTE In the Java installation screen you may see a check box asking if you want to install a toolbar If you do not want to add any toolbars to your Internet browser make sure to de select that option by clicking the check box 6 Next CareLink iPro will install the SerialPort and Dock USB drivers Follow the on screen instructions to install these components After all items have been successfully installed the CareLink iPro screen will say Prepare iPro2 Recorder for upload a Connect the iPro2 Dock to the computer using the USB cable You should see a small pop up at the bottom of your screen that says Medtronic iPro2 Dock This means that the driver for the Dock is successfully installed b Click Cancel to cancel
86. ows 8 32 bit or Windows 8 64 bit If your computer is running one of these operating systems you may need to use the manufacturer s serial cable iPro2 CGM User Guide Introduction 6 Computer system requirements Computers running CareLink iPro must have the following software installed e Operating system Microsoft Windows XP Professional 32 bit Service Pack 3 or greater Microsoft Windows XP Home 32 bit Service Pack 3 or greater Microsoft Windows Vista Business 32 bit or 64 bit Service Pack 1 or greater Microsoft Windows 7 Ultimate 32 bit or 64 bit Microsoft Windows 8 Windows 8 Pro and Windows 8 Enterprise 32 bit or 64 bit from the desktop only e Internet browser Microsoft Internet Explorer 6 32 bit Microsoft Internet Explorer 7 32 bit or 64 bit Microsoft Internet Explorer 8 32 bit or 64 bit Microsoft Internet Explorer 9 32 bit or 64 bit Microsoft Internet Explorer 10 32 bit or 64 bit NOTE On Windows 8 from the Start screen click the Desktop tile and make sure you are viewing the desktop before you open your browser Mozilla Firefox 3 or greater 32 bit e Sun Microsystems Java 6 or greater Adobe Reader 5 0 or greater e USB device drivers for meters that use a USB cable to connect to the computer for uploading data For more information see the instructions provided by the meter manufacturer The manu
87. racy of the sensor glucose values in comparison with the BG meter readings used for the calibration Each BG meter reading used for calibration is paired with the corresponding sensor glucose value generated by the calibration algorithm at the same point in time Not all BG meter readings used for calibration are considered valid for purposes of optimal accuracy evaluation If no other BG meter reading used for calibration exists within 12 hours before or after a calibration then the BG meter reading is not considered valid for purposes of optimal accuracy determination Only BG meter readings between 40 and 400 mg dL 2 2 and 22 2 mmol L will be used for calibration Correlation 0 79 or greater is considered optimal If the Correlation is less than 0 79 then that calendar day does not meet this threshold and will be designated with an X Use Clinical Judgment When the BG meter reading range is less than 100 mg dL or 5 6 mmol L or the number of valid calibrations is less than 3 then the Correlation is reported as N A and is not evaluated for purposes of optimal accuracy If the correlation is high close to 1 0 but the MAD is high this can be due to a single outlying BG meter reading This would cause a Use Clinical Judgment designation There are also two other designations that can appear on the Daily Overlay Report S No Sensor Data and C No Calibration BG s S No Sensor Data This designation occurs on a calendar day in
88. ro2 or a blood glucose meter enter Logbook data or review or print reports will need a CareLink iPro user account iPro2 CGM User Guide One time CareLink iPro software and computer setup 16 Any user with administrative privileges also known as an Admin user can add and delete user accounts An Admin user can also access a user account to change the password or other information in the user account It is a good idea to give administrative privileges to at least two users Having two Admin users means that the clinic does not have to rely on only one person for things like setting up new user accounts or removing users when they no longer need access As staff changes at a clinic make sure that two or more staff members have administrative privileges 1 Geta list of names and email addresses for staff members who need CareLink iPro user accounts 2 In the Clinic Settings tab click Users The existing user accounts are displayed If you are not logged in as an Admin user you will not see the Users tab 3 Click the Create new user button The Create New User screen appears 4 Enter the required information about the user 5 If you want this user to have permission to manage user accounts select the Administrative Privileges check box Important Always make sure that at least two people have administrative privileges If an Admin user leaves the clinic add a new one 6 Click Save NOTE Usernames must be unique among all
89. s and previously generated reports are not affected For more details about how to set different report settings for a particular patient see Patient Report Settings on page 53 General Report Settings The General Report Settings determine how glucose and time information will be displayed in patient reports e Glucose Target Range fields Select a glucose target range to use in the reports e Glucose Units Select the appropriate units for reporting glucose amounts mg dL or mmol L e Time Display Select 12 hour or 24 hour time display format Overlay by Meal Report Settings The Glucose Target Range fields specify a Before Meal and After Meal glucose target range for each of the three meal periods The overnight periods of Evening and Sleeping contain a single target range You may enter a high value and low value for a target range according to the following rules e If you have selected mg dL as the Glucose Units The format for entering the low value for the target range is xxx for example 123 The low value must be at least 40 and must be at least 2 mg dL below the high value The format for entering the high value for the target range is xxx for example 123 The range can be from 60 to 300 e If you have selected mmol L as the Glucose Units iPro2 CGM User Guide One time CareLink iPro software and computer setup 18 The format for entering the low value for the target range is xx x for example 12 3 The low v
90. s data Please refer to the User Guide for assistance The data on the iPro2 cannot be recovered CareLink iPro cannot complete the data upload There may be a problem with the device Contact the 24 Hour HelpLine for assistance You may be instructed to reset the iPro2 Please note that resetting the iPro2 erases all data from the iPro2 CareLink iPro displayed this message during the meter upload process An unrecoverable data error has been detected in the device s data Please refer to the User Guide for assistance This message is different from the message above It appears when CareLink iPro cannot complete the meter data upload Enter the BG meter readings manually using the Logbook screen in CareLink iPro iPro2 CGM User Guide Troubleshooting 72 Checking the iPro2 connector pins If the troubleshooting reference advises you to check the connector pins of the iPro2 use the following image to assist you This image is an example of how the connector pins should look connector opening connector pins housing Look inside the iPro2 s connector opening to make sure that the connector pins are not damaged or corroded If the connector pins are damaged or corroded the iPro2 cannot communicate with the Dock or CareLink iPro Contact the 24 Hour HelpLine It may be time to replace the iPro2 Also look for moisture inside the connector opening If you see any moisture allow the iPro2 to dr
91. s to determine the accuracy of the data number of valid calibrations mean absolute difference percentage MAD and correlation Days that do not meet one of the thresholds are designated as Use Clinical Judgment This designation appears in two places on the Daily Overlay Report and on the Daily Summary Report for the individual day graph On the Daily Overlay Report those days that do not satisfy the criteria are marked with an X in the Designation row If the Designation area is blank for a certain day on the Daily Overlay Report then the data for that day passes all optimal accuracy criteria iPro2 CGM User Guide CareLink iPro reports 51 MAD the threshold for MAD will vary depending on the range of BG meter values for the calendar day If the calendar day does not meet this threshold it will be designated with an X Use Clinical Judgment If the BG meter reading range is greater than or equal to 100 mg dL or 5 6 mmol L then an MAD of 28 0 or less is considered optimal If the BG meter reading range is less than 100 mg dL or 5 6 mmol L then an MAD of 18 0 or less is considered optimal Valid Calibrations 3 or more is considered optimal If there are less than 3 valid calibrations in a calendar day then that day does not meet this threshold and will be designated with an X Use Clinical Judgment This commonly occurs on a partial day of sensor wear such as the last day of the study The system evaluates the accu
92. ser Guide Patient setup 27 Tips for a successful patient study e Keep the sensor hydrated and fully inserted throughout the study Make sure to follow the sensor insertion instructions carefully Choose a good sensor insertion site Use the proper angle for insertion Apply an adhesive dressing over the sensor and iPro2 e If you see gaps in sensor data it could be caused by any of the following reasons The sensor was partially removed during the study which means that no data was being collected for that period of time The iPro2 lost its connection with the sensor If the iPro2 is disconnected from the sensor and then reconnected during the study it will continue recording However there will be a gap in the sensor data The length of the gap depends on how long the iPro2 was disconnected The sensor was not continuously hydrated while connected to the body It is possible for the sensor to lose hydration and then regain it even if it does not pull out CareLink iPro does not have good BG meter readings within 12 hours of each other to calibrate all of the sensor data e Emphasize to the patient ideally by using a Patient Instructions Sheet the importance of following instructions for blood glucose testing throughout the study Patients should complete at least four BG meter readings per day to avoid data gaps If a patient does not record accurate BG meter readings frequently enough CareLink iPro will not have enou
93. sheets entering data 46 Logbook adding entries 46 editing entries 47 entering data 46 excluding BG meter readings 47 opening 46 removing entries 48 sorting entries 48 logging in to CareLink iPro 16 M maintenance system 61 meals entering in Logbook 46 medication entering in Logbook 46 meter excluding meter readings 47 uploading data 45 meter use patient instructions 31 meters supported 6 modifying clinic information 58 Logbook entries 47 patient report settings 53 user accounts 59 moving a patient study 58 notices warranty 88 office registration 15 opening Logbook screen 46 patient record 42 operating system requirements 7 optimal accuracy criteria 51 Overlay by Meal report about 51 settings 18 P password CareLink iPro 57 patient briefing 30 instructions 30 setup 25 patient information editing 57 patient instructions care and wearing 31 meter use first day 31 meter use remaining days 31 patient instructions sheet printing new copies 24 patient log sheet printing new copies 24 patient records opening 42 patient report settings 53 patient return visit 35 patient study moving a patient study 58 tips for success 28 precautions 5 preparing for patient study about 26 wiping iPro2 with alcohol 27 preparing for sensor insertion 29 iPro2 CGM User Guide Index 95 preparing to connect iPro2 32 previewing reports 50 printing reports 50 Q quick reference Dock lights 74
94. sion NOTE In vivo precision studies have not been performed to date and therefore results may differ due to matrix effects Precision of the CGM system was evaluated in vitro by calibrating sensors in solutions with known glucose concentrations measured using a YSI Glucose Analyzer and then repeatedly performing measurement at least 10 times in solution with concentrations across the operation range The average coefficient of variation was 5 06 The average coefficients of variation for the specific glucose concentrations that were utilized for this evaluation are provided in the table below 50 mg dL 9 2 150 mg dL 2 9 250 mg dL 2 3 300 mg dL 5 5 Interference In vitro and in vivo testing suggests that usual pharmacologic levels of acetaminophen and ascorbic acid have a minimal effect on the function of the CGM system In vitro testing suggests that normal physiological levels of uric acid do not affect sensor function The impact of oral hypoglycemic agents lipids bilirubin and other potential interfering substances have not been studied Limitations Since the CGM system requires calibration using a blood glucose value obtained from a home glucose meter any inaccuracy in value obtained from the reference meter will affect the accuracy of the value calculated by the CGM system Also since the sensitivity of the sensor may change failure to recalibrate the sensor at least four times daily may result in
95. study Preparation for sensor insertion Inserting the sensor Briefing the patient Meter use First day Remaining days Care and wearing instructions Preparing to connect the iPro2 after briefing the patient Connecting the iPro2 to the sensor Uploading data to CareLink iPro Before you begin Disconnecting the iPro2 and removing the sensor Disconnecting the iPro2 from the sensor Removing the sensor from the patient Cleaning and disinfecting the iPro2 Opening the patient record Uploading iPro2 data Uploading blood glucose meter data Entering Patient Log Sheet data Opening the Logbook Adding Logbook entries Excluding BG meter readings Editing Logbook entries Removing Logbook entries Sorting the Logbook entries CareLink iPro reports Viewing and printing patient reports Tips for successful report generation About reports Optimal accuracy Area under the curve AUC Patient Report Settings Restoring the default report settings iPro2 CGM User Guide Contents vi Chapter 7 Chapter 8 Appendix A Appendix B Appendix C 55 55 56 57 57 57 57 58 58 59 59 59 60 61 62 62 62 63 64 66 66 70 73 74 75 77 77 77 77 78 78 79 80 80 80 81 82 82 84 Generating a Data Table report Exporting data to CSV file CareLink iPro ongoing use User tasks Printing more log sheets and other forms Changing your password or other user information Editing patient information Moving a patient study Modifyin
96. tem a Navigate to Start gt All Programs b Right click on the Internet Explorer menu item 4 Select Run as Administrator 5 When the User Account Control window is displayed click Allow or Yes NOTE If you are not logged in as an administrator on your computer you may be asked to enter an administrator user s password 6 The system will now allow software components to be installed Complete the procedure described in Set up computers for uploading on page 19 Make sure to return and complete the final step of this procedure when you are finished iPro2 CGM User Guide One time CareLink iPro software and computer setup 21 Required Internet browser settings On all computers where you plan to use CareLink iPro your Internet browser either Internet Explorer or Firefox must have the following settings enabled e JavaScript e Secure Sockets Layer SSL version 3 0 with 128 bit encryption e Cookies e Applets e ActiveX Enabling JavaScript The system uses JavaScript to perform some of its functions JavaScript is enabled by default for most Internet browsers If the JavaScript setting for your Internet browser is disabled you need to enable this setting in order to use the system Enabling JavaScript in Internet Explorer Take the following steps if you need to enable JavaScript or want to check the setting 1 From the Internet Explorer menu options select Tools gt Internet Options The Internet Options page is
97. the Resources hyperlink in CareLink iPro to download document resources such as Patient Log Sheets Clinic Equipment Log Sheets and other useful materials For example you can download a sample Patient Consent Form in Microsoft Word format This form allows you to easily create actual Patient Consent Forms that are appropriate for your office These resources are free from Medtronic for your use with iPro2 Medtronic may occasionally update these resources based on feedback from users like you iPro2 CGM User Guide One time CareLink iPro software and computer setup 24 Patient setup 2 insert sensor connect iPro2 me 2 E a aerva ER 23 GT 5XXXXXXM xX O N Reon ZN tas A ea Key Notes Use universal precautions when handling the sensor and iPro2 Do not use IV Prep prior to sensor insertion It can damage the sensor Wait 15 minutes before connecting the iPro2 Use this time to give instructions to the patient Before setting up any patients on iPro2 make sure that your clinic has completed the one time CareLink software and computer setup instructions in the previous chapter iPro2 CGM User Guide Patientsetup 25 Preparing for study Before the patient arrives in your office make sure that all the necessary equipment and supplies are available and ready Materials needed for patient setup e Cleaning plug e Alcohol swabs e Gloves Sen serter e Glucose sens
98. the demonstration upload iPro2 CGM User Guide One time CareLink iPro software and computer setup 20 7 Verify that Adobe Reader is installed on the computer If Adobe Reader is not installed go to http www adobe com reader to download and install Adobe Reader so that you will be able to open and view reports 8 Click the Home tab to close the sample patient record The computer is now ready for you to upload data 9 Repeat this process on each computer that may be used to upload sensor data from an iPro2 using the Dock On each computer that will be used to view reports only make sure that Adobe Reader is installed Required settings for Windows Vista Windows 7 and Windows 8 users If your computer is running the Windows Vista Windows 7 or Windows 8 operating system there are some additional steps to follow in order to prepare your computer for uploading device data 1 Make sure that User Account Control is enabled By default User Account Control is already enabled so it is likely that you do not have to enable it For details please see the Microsoft documentation 2 Close Internet Explorer 3 If you are using the Windows 8 operating system a From the Start screen click the Desktop tile and make sure you are viewing the desktop b Right click on the Internet Explorer icon in the task bar c In the menu that appears right click again on Internet Explorer If you are using the Windows 7 or Windows Vista operating sys
99. tions and exclusions stated herein This warranty applies only to new devices In the event a iPro2 or Dock is repaired or replaced the warranty period will not be extended past its original expiration date This warranty is valid only if the iPro2 or Dock is used in accordance with the manufacturer s instructions Without limitation this warranty will not apply e If damage results from changes or modifications made to the iPro2 or Dock by the user or third parties after the date of sale e If service or repairs are performed by any person or entity other than the manufacturer e If damage results from a Force Majeure or other event beyond the control of the manufacturer If damage results from negligence or improper use including but not limited to improper storage submersion in fluid physical abuse such as dropping or e If fluid has entered the inside of the iPro2 connector opening or the Dock This warranty shall be personal to the original user Any sale rental or other transfer or use of the product covered by this warranty to or by a user other than the original user shall cause this warranty to immediately terminate This warranty does not apply to glucose sensors and other accessories The remedies provided for in this warranty are the exclusive remedies available for any defects in material or workmanship in the product Neither Medtronic Diabetes nor its suppliers or distributors shall be liable for any incidental cons
100. tuations Electromagnetic propagation is affected by absorption and reflection from structures objects and people a Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the iPro2 CGM system is used exceeds the application RF compliance level above the iPro2 CGM system should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as re orienting or relocating the iPro2 CGM system b Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m iPro2 CGM User Guide Specifications and notices 86 Recommended separation distances between portable and mobile RF communications equipment and the iPro2 CGM system This section provides information on the recommended separation distance between portable and mobile RF communications equipment and the iPro2 CGM system The iPro2 CGM system is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or users of the iPro2 digital recorder can help prevent electromagnetic interference by maint
101. uids can cause the connector pins to corrode and may affect the iPro2 s performance e The iPro2 must be disinfected after every use on a patient Users must adhere to universal precautions when handling or using this device For more information refer to Guideline for Isolation Precautions Preventing Transmission of Infectious Agents in Healthcare Settings 2007 www cdc gov hicpac 2007ip 2007isolationprecautions iPro2 CGM User Guide Introduction 5 Meters supported by CareLink iPro for uploading Data from the following blood glucose meters can be uploaded to CareLink iPro You will need a meter cable as supplied by the meter manufacturer Meter cables are not supplied as part of the iPro2 system If a patient uses a meter that is not listed here you can manually enter the BG meter readings into CareLink iPro CONTOUR CONTOUR NEXT EZ Bayer BREEZE BREEZE 2 OneTouch UltraLink OneTouch Ultra LifeScan OneTouch Ultra 2 OneTouch UltraSmart OneTouch UltraMini Abbott Abbott MediSense Precision Xtra ACCU CHEK Aviva Roche available in the U S and Canada only ACCU CHEK Compact Plus The manufacturer of this device provides two types of cables USB and serial CareLink iPro supports the serial cable only t Some meter manufacturers may not provide a USB device driver for uploading to Windows Vista 64 bit Windows 7 32 bit Windows 7 64 bit Wind
102. which showed consistency in measurement for all categorical groupings Clarke Error Grid analysis Temporally paired glucose readings from the CGM system and reference meter BG were plotted as Clarke Error Grid CEG scatter plots Tabulation of these values demonstrated that 92 93 of paired points in the overall subject population fell in zones A and B of the CEG In the two highest comparative glucose ranges greater than 55 of paired points fell in zone A In the 40 80 and 81 120 mg dL comparative glucose ranges the values of the paired points that fell in zone A were 52 16 and 51 74 respectively iPro2 CGM User Guide Sensor performance 78 40 80 717 374 52 16 164 22 87 0 0 00 177 24 69 2 0 28 81 120 1090 564 51 74 519 47 61 7 0 64 0 0 00 0 0 00 121 240 1829 1083 59 21 721 39 42 20 1 09 0 0 00 5 0 27 gt 240 385 220 57 14 92 23 90 5 1 30 67 17 40 1 0 26 Overall 4021 2241 55 73 1496 37 20 32 0 80 244 6 07 8 0 20 Sensor BG mg dL 0 50 100 150 200 250 300 350 400 Meter BG mg dL Linear regression Linearity response of the CGM system was evaluated in vivo by determining the best fit between the CGM system and reference glucose values This testing yielded the following result y 0 78x 27 slope 0 78 Cl 0 75625760 to 0 79431608 intercept 27 mg dL CI 23 67009704 to 29 68155449 r 0 78 range 40 400 mg dL iPro2 CGM User Guide Sensor performance 79 Preci
103. y for at least one hour Moisture inside the connector opening could cause the iPro2 to not work properly and could cause corrosion and damage over time To help prevent damage to the pins e Make sure to carefully connect the cleaning plug or sensor to the iPro2 e Do not twist or bend the cleaning plug or sensor when connecting to the iPro2 For instructions on how to properly clean the iPro2 using the cleaning plug see Cleaning and disinfecting the iPro2 on page 37 For instructions on how to properly connect the iPro2 to a sensor see Connecting the iPro2 to the sensor on page 32 iPro2 CGM User Guide Troubleshooting 73 Dock lights quick reference All of the lights are off The white Dock power light is on The Dock is not plugged into an electrical outlet or computer USB port If it is plugged in it may not be receiving enough power The Dock is connected to power If connected to an electrical outlet it is ready to charge an iPro2 If connected to a computer USB port it is ready to charge an iPro2 or upload data from an iPro2 The iPro2 is not connected to the Dock All three lights flash once All of the Dock lights flash once when you first connect the Dock to a sufficient power source or when you connect the iPro2 to the Dock The white Dock power light is on and the green charging light is flashing continuously The iPro2 is charging or the iPro2 contains data that must be uploaded using CareLink iPr
104. y but comfortably and secure the iPro2 loosely to allow some movement Important If the sensor is pulled out by more than a millimeter the iPro2 will stop collecting data until the sensor is pushed back in place When the sensor is pushed back in the iPro2 will start collecting data 30 minutes later iPro2 CGM User Guide Patient setup 34 Uploading data to CareLink iPro clean and disinfect iPro2 upload data 3 4 remove iPro2 and sensor e 7 Key Notes e Always clean and disinfect the iPro2 as described in Cleaning and disinfecting the iPro2 on page 37 before connecting it to the Dock Always discard used gloves immediately after disinfecting the iPro2 The Dock connector cannot be disinfected e Ifyou see any body fluid in the iPro2 connector opening do not connect the iPro2 to the Dock Instead you must discard the iPro2 after disinfecting it as described in Cleaning and disinfecting the iPro2 on page 37 e Always protect the iPro2 s connector pins with a watertight cleaning plug when cleaning and disinfecting Replace the cleaning plug after 30 uses to maintain a watertight seal iPro2 CGM User Guide Uploading data to CareLink iPro 35 Do not connect more than one Dock or blood glucose meter to the computer at one time Make sure that both ends of the Dock USB cable are completely connected Before you begin When the patient returns after wearing the iPro2 you will need the following
105. you will take to complete each task e You will also see a Key Notes area on each chapter overview page These are the important points for you to remember from that chapter iPro2 CGM User Guide Introduction 1 iPro2 system These are the components of the iPro2 CGM system iPro 2 digital recorder MMT 7741 iPro2 The iPro2 collects and stores data from a glucose sensor The data can be uploaded into CareLink iPro Therapy Management Software for Diabetes CareLink iPro MMT 7340 to generate reports and store the data The iPro2 can collect up to seven 24 hour periods of data after which it shuts off automatically The iPro2 has an internal green light ey This light flashes when you connect the iPro2 to an inserted glucose sensor It will only flash if the iPro2 detects an adequately hydrated sensor is fully charged and does not already contain any data The iPro2 can be used 60 times Keep track of iPro2 uses by entering each use on the Clinic Equipment Log Discard the iPro2 after 60 uses If you continue to use the iPro2 beyond 60 times the disinfection process may damage the device iPro 2 Docking Station MMT 7742 Dock The Dock has two main functions charging the iPro2 and uploading data from the iPro2 to CareLink iPro The Dock has three lights to provide status information The white Dock power light indicates whether power is supplied to the Dock When you connect the iPro2 to the Dock the green chargin

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