STANDARD OPERATING PROCEDURE MEDTRONIC MINIMED CGMS SYSTEM GOLD

Transcription

1 Table of Contents Page 1. Scope 2 2. Objective 2 3. Definitions 2 4. Responsibility 5 5. Procedure 6 6. Precautions References Appendices Revision History 35 Original Authorised Copy for: Reading Copy Written by: Reviewed by: Approved by: Signature/Date: Signature/Date: Signature/Date: Page 1 of 38

2 1. Scope This Standard Operating Procedure (SOP) applies to the staff and students using the Medtronic Minimed CGMS System Gold in the Pharmacy Practice Resource Unit (PPRU) at the Pharmacy Department, University of Malta. 2. Objective To describe the procedure for the set up, operation, maintenance and troubleshooting of the Medtronic Minimed CGMS System Gold. 3. Definitions 3.1. ACT (Activate) Button: To confirm chosen parameters during monitor set up and to turn off the alarms Belt Clip: Used to attach the monitor to a belt or a piece of clothing Cable: Links the sensor to the monitor via 2 types of connectors i.e. the sensor and the monitor connectors. The sensor connector allows the cable to be securely connected to the sensor whilst the monitor connector allows the cable to be securely connected to the monitor Cable Tool: Used to securely attach the cable to the monitor Calibration: A procedure to ensure that the monitor is able to convert electronic signals received from the sensor into glucose values. This is achieved by entering periodic finger stick glucose readings into the monitor Com-Station: A device that allows the transfer of data from the monitor to a computer. Infrared ports are the communication link with the monitor and an RS-232 cable is the communication link with the computer. The following are the operating components of the Com-Station: AC Adapter Port: The location in which the power supply connection is connected to the Com-Station Communications Ports A and B: Through a computer cable, provides a data link between the Com-Station and the computer (Com-Port A) or a memory glucose meter (Com-Port B) Page 2 of 38

3 Device Selector Switch: Selects the data download source from either a continuous glucose monitor (the wave symbol) or a memory glucose meter (B symbol) Monitor Cradle: A depression in the Com-Station where the monitor is placed to download data from its memory. It contains various infrared ports which act as the communication link between the monitor and the computer On/Off Switch: To switch the Com-Station On or Off Down Arrow: To choose between and commands and to find the next lowest preset value Events Menu: Enables user to record a number of events such as meals and snacks, insulin dosages, exercise and illnesses or any other activity that may affect blood glucose levels Exporting Files: A function that allows data to be imported into other software applications such as Microsoft Excel for further analysis Finger Stick Glucose Measurement: A glucose reading obtained through the use of another separate point-of-care testing glucose device and is used for monitor calibration Home Screen: Displays the current time Initialisation Period: The process of equilibrating the electronic signal generated by the sensor after it has been inserted in the subcutaneous tissue. During this period, the sensor becomes wet with the interstitial fluid and the glucose oxidase reaction starts to become stabilised ISIG: The acronym for Interstitial Signal i.e. the electrical current, measured in nanoamperes (na), that is sent to the monitor via the sensor Medtronic Minimed CGMS System Gold : A continuous glucose monitoring device used to continuously monitor glucose levels in the interstitial fluid within a range of mg/dL (or mmol/L). The enzyme glucose oxidase converts the glucose at the surface of the sensor into electrical signals which are sent through the cable to the monitor. The monitor will sample the received signals once every 10 seconds and records an average signal every 5 minutes. The stored signals are then converted into glucose concentrations once these are downloaded in a computer. Page 3 of 38

4 3.15. Memory: Stores up to 14 days of data which can then be transferred to a computer for further analysis Monitor: Displays all the functions that are available for the device and continuously stores electronic signals that are received from the sensor. All the stored data is downloaded in a computer, via the Com-Station, for conversion to glucose readings On/Off Button: To switch the monitor On or Off. Switching the monitor Off will not allow new glucose data to be recorded into Memory Operating Menus: Four different menus that can be accessed from the Home Screen i.e. [METER BG], [EVENT], [SIGNALS] and [SETUP] Patient Entry and Edit Screen: Allows the user to create new patient files, to edit existing ones, to open prior version files, to change an individual patient s glucose target range and to change an individual patient s time range blocks Reports Menu: Consists of 5 report types that can be displayed and these are: Sensor Daily Details Report: Provides the user with up to 14 days of individual data plots Sensor Data Report: A computerised logbook that presents all of the data stored in the monitor memory for a patient download Sensor Modal Day Report: Represents all the glucose data over a 24- hour period were each day is represented as a separate plot line in a different colour Sensor Modal Time Periods Report: Provides an analysis of each of the Time Range Blocks Sensor Summary Report: Includes a tabular summary of the statistical data from the CGMS and the glucose data that was entered into the monitor SEL (Select) Button: To scroll through each of the displays and menus available Sen-serter: Used to help insert the sensor through the skin and into the subcutaneous tissue. Page 4 of 38

5 3.23. Sensor: A small device that is placed in the subcutaneous tissue which produces a signal that is proportional to the concentration of glucose in the interstitial fluid. It is to be stored in a refrigerated environment Sensor Insertion Site: A site that contains adequate subcutaneous tissue for sensor insertion. The lower abdomen and the upper, outer quadrant of the buttocks are the sites most frequently used Set Up Menu: Consists of 7 options which are used to set the monitor according to the user s preferences i.e. [CLEAR], [PATIENT], [INIT], [SET TIME], [UNIT], [LOCK] and [EXIT]. Refer to /A1 for further details on each option Shower-Pak: A waterproof, clear-plastic pouch used to keep the monitor dry during a shower or in any other situation that may cause the monitor to get wet. However, it is not intended to protect the monitor from submersion in water Solutions Software: A computer programme designed to extract glucose data from the Medtronic Minimed CGMS System Gold Test Plug: A device used to provide diagnostic information that can help identify if a sensor, cable or monitor is/are operating in the correct manner. Refer to /A2 for further details on how to use the test plug Up Button: To select between and commands and to find the next highest preset value User Preferences Menu: A menu in the Solutions Software computer programme consisting of 3 sub-menus i.e. [General], [Reports] and [Clinic Info] that are used to set the default patient information for all the patient s reports. 4. Responsibility 4.1. The members of the Department of Pharmacy (staff and students) are responsible for following this SOP The designated Laboratory Officer or Laboratory Assistant is responsible for ensuring that this SOP is followed. Page 5 of 38

6 5. Procedure 5.1. Set Up Monitor Set Up Insert 2 new AAA alkaline batteries into the battery compartment Press the On/Off button to switch the monitor On Wait until the monitor performs its routine diagnostic test and the Home Screen is displayed Press the SEL button 4 times. [SETUP] will be displayed Press the ACT button Repeatedly press the SEL button to scroll through the 7 different options available in the Set Up menu (Refer to /A1) Press the ACT button whilst [EXIT] is displayed to exit the Set Up menu and return to the Home Screen Sensor Insertion Wash hands well with soap and water Wear a suitable pair of disposable gloves Take out a sensor package from the refrigerator Allow the sensor package to reach room temperature Choose an appropriate sensor insertion site (see 3.24) Clean sensor insertion site with alcohol Allow the sensor insertion site to dry completely before inserting a sensor Remove the sensor from its packaging Place the sensor in the Sen-serter Hold the Sen-serter upright, secure the white tape of the sensor and remove the clear tape using an anticlockwise motion Place fingers on the back of the white tape and push the carrier down until it clicks into place Remove the needle guard from the introducer needle Rest the Sen-serter legs against the skin at a 45 o angle Press the white button on the Sen-serter Check that the sensor has been inserted properly through the skin Hold the sensor in place and gently slide the Sen-serter away from the sensor. Page 6 of 38

7 Remove the white paper from the adhesive pad and press it against the skin Hold the sensor with two fingers on its base and gently remove the introducer needle at a 45 o angle Dispose the introducer needle into a sharps container Connecting the Cable Place the monitor connector end of the cable above the monitor connection port until slight contact is made Align the arrow on the monitor connector with the arrow on the monitor connection port Place the groove on the side of the cable tool on the corresponding groove on the monitor connector Apply pressure to advance the monitor connector into the monitor connection port Check that both arrows on the monitor connector and on the monitor connection port are still properly aligned Grasp the sensor base between the thumb and forefinger Orient the sensor connector end of the cable to be in close proximity to the connection of the sensor Plug the sensor connector end of the cable to the sensor Press both parts together until they snap in place Cover the insertion site with a transparent sterile dressing View the [ISIG] screen (see section 5.2.2) for 1-2 minutes to ensure that the sensor current is adequate and stable Sensor Initialisation Repeatedly press the SEL button, while in Home Screen, until [SETUP] is displayed Press the ACT button Repeatedly press the SEL button until [INIT] is displayed Press the ACT button. Monitor will beep and [NO] will flash Press the Up or Down arrow button to select [YES] Press the ACT button to begin the initialisation process Wait for one hour for the initialisation process to be complete. The monitor will continuously countdown the time remaining Wait for the monitor to beep to indicate that the initialisation process is complete. Page 7 of 38

8 Sensor Calibration Perform the first sensor calibration when sensor initialisation is complete Perform a finger stick glucose measurement Press the SEL button once while in Home Screen. [METER BG] is displayed Press the ACT button and wait for [---] and [ENTER BG] to be displayed Use the Up and Down arrow buttons to enter the glucose measurement reading in increments of 1mg/dL (or 0.1mmol/L) Press the ACT button to confirm If an alarm is heard and [CAL ERR] is displayed within approximately 1-2 minutes, the entered glucose reading is outside the sensitivity check expected ranges (Refer to section 5.4 for possible solutions) Repeat sensor calibration procedure at least 4 times daily. A combination of fasting, preprandial and postprandial values are ideal Using the Monitor Belt Clip Slide the triangular-shaped ridge on the back of the belt clip into its corresponding groove on the back of the monitor Keep pushing the belt clip until it snaps into place If belt clip is to be removed, lift the grooved edge of the belt clip with thumb and gently slide the clip out of its groove Installing the Solutions Software Insert the Medtronic MiniMed CGMS Solutions Software CD into the CD drive Double click on the My Computer icon on the Windows desktop Right click on the CD drive Click on Open Double click on the SETUP.EXE file Click the Next button Read the Software License Agreement Click the button Click the Next button to accept the default destination location for installation. Page 8 of 38

9 Click the Next button to accept the default destination folder to save the patients download files. If another file is desired, click the Browse button to select another location Click the Next button. The Select Program Folder window will now be displayed Click the Next button to accept the MiniMed Solutions CGMS Sensor software Click the Next button when the Start Copying Files window is displayed Wait until the setup status reaches 100% Click the Finish button when the Setup Complete window is displayed. If a reboot request message appears, accept the request in order to finish the installation process The MiniMed Solutions CGMS Sensor icon will now be displayed on the Windows desktop Setting Up the MiniMed Solutions CGMS Sensor Programme Double click the MiniMed Solutions CGMS Sensor icon on the Windows desktop Check that the device selector switch of the Com-Station is in the wave symbol position Select [User Preferences] from the File Menu From the [General] Menu, click on the arrow of the drop down menu under Com-Port to select the serial port from which the Com-Station is connected to the computer Click the [Check Com-Station] button. If correct Com- Station port was selected, [Com-Station Ready] will be displayed Click the Ok button If the wrong Com-Port was selected, [ Com-Station Detected] will be displayed. Click the Ok button and recheck the connections Select between a 12-hour or a 24-hour time display option Select between mg/dl or mmol/l from the [Report Glucose Units] section Click the Up and Down arrow buttons to change the default glucose target for the Upper and Lower Limits from the [Default Glucose Target] section From the [Reports] Menu, click the checkbox of the Report that needs to be printed Click on the time range block that needs to be changed Click the Up and Down arrows to adjust its time. Page 9 of 38

10 Click outside of the time range block to save the changes made Repeat steps to to change the time setting of other time range blocks From the [Clinic Info] Menu, input the desired clinic name, address and phone number Press the Ok button to save all the changes made to the User Preferences Menu. The Patient Entry and Edit screen will now be displayed Connecting the Com-Station to the Computer 5.2. Operation Connect the computer cable into an available serial Com- Port connector on the computer Connect the other end of the computer cable to Com-Port A of the Com-Station Connect the AC adapter into a suitable power source Connect the other end of the AC Adapter cable to the Com- Station Recording Events in Monitor Press the SEL button twice while in Home Screen. [EVENT] will be displayed Press the ACT button Wait until the word [EVENT] or the most recently entered event, if a previous event had been entered, is flashing Press the ACT button Press the Up and Down buttons to select the desired event i.e. [FOOD], [MEDS], [EXERCISE] or [OTHER] Press the ACT button to accept the chosen event Reading Current and Voltage Sensor Signals in Monitor Press the SEL button 3 times while in Home Screen. [SIGNALS] will be displayed Press the ACT button to display the current, in nanoamperes, in the upper right-hand corner of the screen, together with [+ ISIG]. Page 10 of 38

11 Press the SEL button whilst [ISIG] is displayed to display the voltage, in volts, in the upper right-hand corner of the screen Press the SEL button to return to [ISIG] display Press the ACT button to return to the Home Screen Entering and Editing Patient Information and Downloading Data in Computer Double click the MiniMed Solutions CGMS Sensor icon on the Windows desktop Select [New Patient] from the File menu Enter the patient s first and last name Enter the patient s ID number Enter the name of the physician Use the Up and Down arrow buttons if the Upper and Lower Limits of the [Glucose Target Range] need to be changed Click on any of the Time Range Blocks if the previously set default times need to be changed Press the On/Off switch of the Com-Station to switch it on Check that the monitor is switched on and that it is displaying the Home Screen Place the monitor face up into the Com-Station cradle Check that the monitor fits well in the cradle to ensure that the infrared communications ports are aligned Select [Download Glucose Monitor] from the [Download Data] Menu Click the Download button to initiate the download Wait until the status bar moves through its entire range Click the Ok button when [Download Complete] is displayed Select [Save As] from the File Menu Press the Save button to save the patient file with its default name (i.e. last name, first initial, patient ID and date) Select [Open Existing Patient] from the File Menu to open and/or edit an existing patient file Select the patient file that needs to be opened Click the Open button The Patient Entry and Edit screen will be displayed containing information about the patient Select [Rename Patient File] from the File Menu if the first name, second name or patient ID needs to be changed Click the Ok button. Page 11 of 38

12 Click the Save button when the Save As window is displayed Displaying and Printing Report Results Open an existing patient file Click on the Reports Menu and choose the desired report to be viewed Wait until the report is displayed for that selected patient Select [Print] from the File Menu if report is to be printed Click the Print button on the Sensor List Screen Click the Ok button Exporting Files Close any reports that may be open Select [Export File] from the File Menu. The Save As window will be displayed Check that the correct patient file is being exported Click the Save button Open the desired programme you want to use to view the data Select [Open] from this programme s File Menu Locate the.fst file. The default location is: C:\ Program Files\ MiniMed Inc\ MiniMedSolutions CGMS Sensor\ PatientData Click on the.fst file to be opened Click the Open button. The Text Import Wizard window will be displayed Check that [Delimited] is selected Click the Next button Select the [Other] text box and type in [ ] Click the Next button Click the Finish button. Page 12 of 38

13 5.3. Maintenance Monitor Maintenance Replace batteries if [LOW BATT] or [NO POWER] is displayed and accompanying alarm is heard Clean the outside surface using a moist cloth with a mild cleaning agent Sen-serter Maintenance Clean using a moist cloth with soapy water Disinfect using a moist cloth with 10% bleach or 70% alcohol solution Allow to dry before use or storage Store in the released position to maintain optimum product performance Cable Maintenance Clean the outside surface using a moist cloth with a mild cleaning agent Disinfect using a moist cloth with 70% alcohol solution. Page 13 of 38

14 5.4. Troubleshooting Alarm Message Cause/s Solution/s [DISCONN-] displayed and alarm beeps every 15 - Monitor is not detecting signal from - Check sensor-to-cable and cable-to-monitor connections seconds until sensor - Read the [ISIG] for 15 acknowledged. - Sensor may be seconds Alarm will repeat every 5 minutes as long as disconnected from monitor - If [ISIG] value is > 5 and remains fairly constant, wait monitor continues not to detect a signal - Sensor may have pulled out of insertion site 15 minutes and recalibrate monitor before returning to normal operation - If [ISIG] value is < 5 or highly variable, perform Test Plug Procedure (Refer to [CAL ERR] displayed and alarm beeps every 15 seconds until acknowledged [MEM FULL] displayed and alarm beeps every 15 seconds until acknowledged. Alarm will repeat every 6 hours as long as memory is > 90% full [ISIG HI] displayed and alarm beeps every 15 seconds until acknowledged. Alarm will repeat every 3 The entered finger stick blood glucose reading is either higher or lower than expected Memory used to store glucose data is > 90% full Monitor detected sensor current [ISIG] that is significantly higher than expected /A2) - Press SEL and then ACT to switch alarm off - Check [METER BG] screen to ensure that blood glucose reading was inputted correctly - Check monitor and cable function by performing Test Plug Procedure (Refer to /A2) - Replace sensor if above steps do not resolve error - Press SEL and then ACT to switch alarm off - Download glucose data to a computer within 24 hours after first alarm is heard - Clear all glucose data (Refer to /A1) - Press SEL than ACT to switch alarm off - Take a finger stick glucose measurement. Page 14 of 38

15 minutes as long as sensor current remains higher than expected [LOW BATT] displayed and alarm beeps once. Alarm will repeat every hour until batteries are replaced or loose all power [NO POWER] displayed [E-OX] displayed and alarm beeps every 10 seconds until data is downloaded to pc Batteries have only about 72 hours of remaining power Batteries are only expected to last less than one hour Diagnostic test detected an error in the memory programme - If reading > 400mg/dl (or > 22mmol/l), treat patient accordingly and recalibrate sensor once patient glucose levels become < 400mg/dl - Replace sensor if reading was < 400mg/dl, sensor connections were all properly attached and no moisture was found in the connections Install new batteries and recalibrate sensor Immediately install new batteries and recalibrate sensor Immediately download all data from monitor while this is switched on and then replace monitor Page 15 of 38

16 5.5. Flow Charts Set Up Monitor Set Up Start Insert 2 new AAA alkaline batteries into battery compartment Press On/Off button to switch monitor On Wait until monitor performs its routine diagnostic test and Home Screen is displayed Press SEL button 4 times. [SETUP] will be displayed Press the ACT button Repeatedly press SEL button to scroll through the 7 different options available in Set Up menu (Refer to /A1) Need to exit Set Up menu End Press ACT button whilst [EXIT] is displayed in Set Up menu Page 16 of 38

17 Set Up Sensor Insertion Start Wash hands well with soap and water Wear suitable pair of disposable gloves Take out sensor package from refrigerator Allow sensor package to reach room temperature Choose an appropriate sensor insertion site Clean sensor insertion site with alcohol Allow site to completely dry before inserting sensor Remove sensor from its packaging Place sensor in Sen-serter Hold Sen-serter upright, secure white tape of sensor and remove the clear tape using an anticlockwise motion Place fingers on back of white tape and push carrier down until it clicks into place Remove needle guard from introducer needle Rest Sen-serter legs against the skin at 45 o angle 1 Page 17 of 38

18 1 Press white button on Sen-serter Check that sensor has been inserted properly through the skin Hold sensor in place and gently slide Sen-serter away from sensor Remove white paper from adhesive pad and press it against skin Hold sensor with 2 fingers on its base and gently remove introducer needle at a 45 o angle Dispose introducer needle into sharps container End Page 18 of 38

19 Set Up Connecting the Cable Start Place monitor connector end of cable above monitor connection port until slight contact is made Align arrow on monitor connector with arrow on monitor connection port Place the groove on side of cable tool on corresponding groove on monitor connector Apply pressure to advance monitor connector into monitor connection port Check that both arrows on monitor connector and on monitor connection port are still properly aligned Grasp sensor base between thumb and forefinger Orient sensor connector end of cable to be in close proximity to sensor connection Plug sensor connector end of cable to sensor Press both parts together until they snap Cover insertion site with transparent sterile dressing View [ISIG] screen (Refer to ) for 1-2 minutes to ensure that sensor current is adequate and stable End Page 19 of 38

20 Set up Sensor Initialisation Start Repeatedly press SEL button, while in Home Screen, until [SETUP] is displayed Press ACT button Repeatedly press SEL button until [INIT] is displayed Press ACT button Monitor will beep and [NO] will flash Press Up or Down arrow button to select [YES] Press ACT button to begin initialisation process Wait for 1 hour for the initialisation process to be complete Wait for monitor to beep to indicate that initialisation process is complete End Page 20 of 38

21 Set Up Sensor Calibration Start Sensor initialisation complete Wait for initialisation to be complete Perform first sensor calibration Perform a finger stick glucose measurement Press SEL button once while in Home Screen [METER BG] is displayed Press ACT button and wait for [---] and [ENTER BG] to be displayed Use Up and Down arrow buttons to enter glucose measurement reading in increments of 1mg/dl or 0.1mmol/l Press ACT button to confirm Alarm heard and [CAL ERR] displayed within 1-2 minutes Repeat sensor calibration procedure at least 4 times daily incorporating a combination of fasting, pre-prandial and post-prandial values Entered glucose value is outside the sensitivity check expected ranges Refer to section 5.4 for further details End Page 21 of 38

22 Set Up Using the Monitor Belt Clip Start Slide triangular-shaped ridge on back of belt clip into its corresponding groove on back of monitor Keep pushing belt clip until it snaps into place Need to remove belt clip Lift grooved edge of belt clip with thumb and gently slide clip out of its groove End Page 22 of 38

23 Set Up Installing the Solutions Software Start Insert CGMS Solutions Software CD into CD drive Double click on My Computer icon on Windows desktop Right click on the CD drive Click on Open Double click on SETUP.EXE file Read instructions carefully and when ready click Next button Read Software License Agreement Click button Click Next button to accept default destination location for installation Use default destination folder to save patient files Click on Browse to select another location Click Next button The Select Program Folder window will now be displayed Click Next button to accept MiniMed Solutions CGMS Sensor software 1 Page 23 of 38

24 1 Click Next button when Start Copying Files window is displayed Wait until setup status reaches 100% Reboot request message displayed Click Finish button when Setup Complete window is displayed Accept request to finish installation process MiniMed Solutions CGMS Sensor icon will now be displayed on Windows desktop End Page 24 of 38

25 Set Up Setting up the MiniMed Solutions CGMS Sensor Programme Start Double click MiniMed Solutions CGMS Sensor icon on desktop Check that device selector switch of Com-Station is in the wave symbol position Select [User Preferences] from File Menu Enter General Tab Menu Enter Reports Tab Menu 2 Click [General] Tab Click [Reports] Tab Click on arrow of drop down menu under Com-Port to select serial port from which Com-Station is connected to computer Click Check Com-Station button Click the check box of the Report type to be printed Need to change time range block 2 [Com-Station Ready] displayed Click Ok button [ Com Station] will be displayed to indicate that wrong Com-Port was selected Click Ok button and recheck connections Click on Time Range Block that needs to be changed Click Up and Down arrows to adjust time Select between a 12-hr or 24-hr time display option Click outside of time range block to save changes made Select between mg/dl or mmol/l from [Report Glucose Units] section Change more time range blocks 2 1 Page 25 of 38

26 1 Need to change Upper and/or Lower limit/s of default glucose target Use the Up and Down arrow buttons respectively 2 Enter Clinic Tab Menu Click [Clinic Info] Tab Input desired clinic name, address and phone number Press Ok button to save all changes made to User Preferences Menu End Page 26 of 38

27 Set Up - Connecting the Com-Station to the Computer Start Connect computer cable into an available serial Com-Port connector on computer Connect other end of computer cable to Com-Port A of Com-Station Connect AC adapter into a suitable power source Connect other end of AC Adapter cable to Com-Station End Page 27 of 38

28 Operation Recording Events and Reading Current and Voltage Sensor Signals in Monitor 1 Start Need to record an event Need to read current and voltage sensor signals Press SEL button twice while in Home Screen [EVENT] will be displayed Press SEL button 3 times while in Home Screen Press ACT button [SIGNALS] will be displayed Previous event had already been entered Wait until the word [EVENT] is flashing Press ACT button to display current, in na, together with [+ISIG] Press SEL button whilst [ISIG] is displayed to display voltage Wait until the most recently entered event is flashing Press SEL button to return to [ISIG] display Press ACT button Press ACT button to return to Home Screen Press Up and Down buttons to select the desired event i.e. [FOOD], [MEDS], [EXERCISE] and [OTHER] End 1 Page 28 of 38

29 Operation - Entering and Editing Patient Information and Downloading Data in Computer Start Double click MiniMed Solutions CGMS Sensor icon on desktop Select [New Patient] from File Menu Enter patient s first and last name Enter patient s ID number Enter name of physician Need to change Upper and/or Lower Limits of glucose target range Use Up and Down arrow buttons to change accordingly Set default times need to be changed Click on the desired Time Range Block/s to be changed accordingly Press On/Off switch of Com-Station to switch it on Check that monitor is switched on and that it is displaying Home Screen Place monitor face up into the Com-Station cradle Check that monitor fits well in cradle to ensure that infrared communications ports are aligned Select [Download Glucose Monitor] from Download Data Menu Click Download button to initiate download Wait until status bar moves through its entire range 1 Page 29 of 38

30 1 Click Ok button when [Download Complete] is displayed Select [Save As] from File Menu Press Save button to save patient file with its default name Need to open and/or edit an existing patient file Select patient file that needs to be opened Click Open button Patient Entry and Edit screen will be displayed Need to change 1 st name, 2 nd name or patient ID Select [Rename Patient File] from File Menu Edit the information in the [Rename Patient File] window Press Ok button Click Save button when [Save As] window is displayed End Page 30 of 38

31 Start Operation Displaying and Printing Report Results and Exporting Files Need to display a report for a patient Need to print data Open an existing patient file Select [Print] from File Menu Click on Reports Menu and choose desired report to be viewed Click Print icon on Sensor List Screen Wait until report is displayed for the selected patient Click Ok button Need to export file 1 Close any reports that may be open Select [Export File] from File Menu Save As window will be displayed Check that the correct file is being exported Click Save button Open desired programme you want to use to view data Select Open from this programme s File Menu Locate the.fst file 2 Page 31 of 38

32 2 The default location is: C:\Program Files\ MiniMed Inc\ MiniMedSolutions CGMS Sensor\ PatientData Click on.fst file Click Open button Text Import Wizard window will be displayed Check that [Delimited] is selected Click Next button Select [Other] text box and type in [ ] Click Next button 1 Click Finish button End Page 32 of 38

33 Maintenance Start [LOW BATT] or [NO POWER] displayed and accompanying alarm heard Replace batteries Monitor needs cleaning Sen-serter needs cleaning Cable needs cleaning Clean using a moist cloth with a mild cleaning agent Clean using moist cloth with soapy water Clean using moist cloth with a mild cleaning agent Sen-serter needs to be disinfected Cable needs to be disinfected Disinfect using moist cloth with 10% bleach or 70% alcohol solution Disinfect using moist cloth with 70% alcohol solution Allow to dry before use or storage End Store in released position to maintain optimum product performance Page 33 of 38

34 6. Precautions 6.1. Sensor / Insertion Site Precautions Do not use a sensor if the temperature-limit indicator on its storage box is black in colour Do not use sensor if its package has been already opened or damaged Avoid touching any sensor surfaces that will eventually come in contact with the inside of the body Check that the sensor is securely placed in the Sen-Serter prior to insertion since this may result in pain and minor injury Do not point a loaded Sen-serter towards any body part where insertion is not desired Do not twist, bend or lift the Sen-serter while removing it from the sensor Select a new insertion site that is at least 5cm from the previous insertion site each time a new sensor is to be inserted Do not insert sensors in locations that are constrained by clothing or are subjected to rigorous movements Avoid sensor insertion in the area of the waistline, around navel and in scarred or atrophied tissue For users who inject insulin, instruct patient or carer to administer the injections at least 8 cm away from the sensor insertion site For users who wear an insulin pump, ensure that the sensor insertion site is at least 5 cm away from the insulin infusion site Do not rotate the introducer needle while it is being removed Periodically check the insertion location for any redness, bleeding, pain, tenderness and swelling and to ensure that the sensor remained in place Advise the patient to check the sensor regularly especially before going to bed and after waking up Infection and/or site irritation may result from improper insertion of the sensor at the insertion site Enter sensor calibration values immediately within 5 minutes of obtaining a fingerstick glucose value Recalibrate the sensor whenever the sensor is disconnected and reconnected again Monitor precautions Do not use the monitor in close proximity of strong electromagnetic sources such as medical imaging equipment, television and radio transmitters. Page 34 of 38

35 7. References Check that both the sensor and the monitor are securely fastened to the patient before starting any form of exercise Advise the patient to place the monitor in a Shower-Pak prior to having a shower or engaging in other activities that may wet the monitor Keep the monitor in its original case while it is in use to protect it against bumps and scratches of everyday use Whilst changing batteries, do not leave the monitor for more than 5 minutes without batteries to avoid losing glucose data and programme information Ensure that the finger stick glucose meter readings inputted into the monitor are accurate since inaccurate entries may reduce the accuracy of the calculated glucose readings Avoid taking finger stick blood glucose measurements when the glucose levels may be unstable such as immediately following a meal, insulin delivery or exercise since this may result in readings which are outside the sensitivity check expected ranges. Medtronic MiniMed. CGMS System Gold MMT-7102W user guide. rthridge USA: Medtronic MiniMed; Appendices /A1 Set Up Menu Table /A2 Test Plug Procedure Flow Chart 9. Revision History Version Number Amendments/ Reasons for change 01 Initial Release Page 35 of 38

36 /A1 Set Up Menu Table Display Symbol Function Set-Up CLEAR PATIENT INIT SET TIME To clear the monitor from all glucose results history and calibration data once all information from monitoring period has been downloaded to a computer To enter a patient s unique identification number To start sensor initialisation period To programme the current time and date into the monitor Page 36 of 38 - Press ACT when [CLEAR] is displayed - Wait until the words [CONFIRM] and [NO] are displayed - Use Up and Down arrows to select between [YES] and [NO]. - Press ACT to clear memory if [YES] is chosen - Press ACT to cancel the clear memory operation if [NO] is chosen - Press ACT when [PATIENT] is displayed - Wait until [ ] is displayed - Use Up and Down arrows to select a number between 0-9 for the first blinking digit - Press ACT to confirm and advance to the next digit - Repeat last two steps for all 7 digits See section Press ACT when [SET TIME] is displayed - Press ACT - Wait for [HOUR] to be displayed - Use Up and Down arrows to select hour between 1 and 12 - Press ACT to confirm hour - Wait for [MINUTE] to be displayed - Use Up and Down arrows to select minute between 00 and 59 - Press ACT to confirm - Wait for [YEAR] to be displayed - Use Up and Down arrows to select last two digits of current year - Press ACT to confirm year - Wait for [MONTH] to be displayed - Use Up and Down arrows to select digit for month between 1 and 12

37 UNIT LOCK EXIT To select between mg/dl or mmol/l as the unit for measuring blood glucose To prevent the set parameters from being altered by patient To exit the Set Up menu and return to Home Screen - Press ACT to confirm month - Wait for [DAY] to be displayed - Use Up and Down arrows to select digit for current day between 1 and 31 - Press ACT to confirm day - Press ACT when [UNIT] is displayed - Use Up or Down arrow to select between the two units - Press ACT to confirm chosen unit - Press ACT when [LOCK] is displayed - Use Up or Down arrow to select between [YES] and [NO] - Press ACT to confirm if [YES] is chosen - Press ACT again - Wait for [0] to be displayed - Press the following sequence of buttons to lock the set up menu: UP ARROW SEL DOWN ARROW ACT - Wait for [1,2,3] and [INIT] to be displayed - User is now given the option to start the initialisation process - To unlock set up menu: Press ACT when [UNLOCK] is displayed Press ACT again when [YES] is displayed Wait for [0] to be displayed Press the same button sequence used to lock set up menu Wait for [1,2,3] and [CLEAR] to be displayed - Press ACT when [EXIT] is displayed Page 37 of 38

38 /A2 - Test Plug Procedure Flow Chart Start Disconnect cable from sensor Connect test plug to cable Read ISIG value ISIG reading between 24-29nA Cable or monitor may be faulty Disconnect cable from monitor Sensor no longer useful / has been pulled out of insertion site or sensor connector may have gotten wet Replace cable with test plug Remove old sensor and insert new one Read ISIG value Initialise and recalibrate new sensor ISIG reading between 24-29nA Monitor may be malfunctioned Call supplier Cable may be malfunctioned Disconnect test plug from monitor Plug in a new cable to monitor Remove old sensor and insert a new one Connect new cable to sensor Initialise and calibrate new sensor End Page 38 of 38