UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/214_02
STANDARD OPERATING PROCEDURE
MEDTRONIC MINIMED CGMS®
SYSTEM GOLD™
Page 1 of 38
Valid for:
2 years from
approval
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/214_02
STANDARD OPERATING PROCEDURE
MEDTRONIC MINIMED CGMS®
SYSTEM GOLD™
Valid for:
2 years from
approval
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.
3.2.
Belt Clip: Used to attach the monitor to a belt or a piece of clothing.
3.3.
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.
3.4.
Cable Tool: Used to securely attach the cable to the monitor.
3.5.
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.
3.6.
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:
3.6.1.
3.6.2.
3.6.3.
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)
Device Selector Switch: Selects the data download source from either
a continuous glucose monitor (the wave symbol) or a memory glucose
meter (B symbol).
Page 2 of 38
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/214_02
STANDARD OPERATING PROCEDURE
MEDTRONIC MINIMED CGMS®
SYSTEM GOLD™
3.6.4.
3.6.5.
Valid for:
2 years from
approval
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.
3.7.
Down Arrow: To choose between “No” and “Yes” commands and to find the
next lowest preset value.
3.8.
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.
3.9.
Exporting Files: A function that allows data to be imported into other
software applications such as Microsoft™ Excel for further analysis.
3.10. 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.
3.11. Home Screen: Displays the current time.
3.12. 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.
3.13. ISIG: The acronym for Interstitial Signal i.e. the electrical current, measured
in nanoamperes (nA), that is sent to the monitor via the sensor.
3.14. Medtronic Minimed CGMS® System Gold™: A continuous glucose
monitoring device used to continuously monitor glucose levels in the
interstitial fluid within a range of 40-400mg/dL (or 2.2-22mmol/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.
3.15. Memory: Stores up to 14 days of data which can then be transferred to a
computer for further analysis.
Page 3 of 38
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/214_02
STANDARD OPERATING PROCEDURE
MEDTRONIC MINIMED CGMS®
SYSTEM GOLD™
Valid for:
2 years from
approval
3.16. 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.
3.17. 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.
3.18. Operating Menus: Four different menus that can be accessed from the Home
Screen i.e. [METER BG], [EVENT], [SIGNALS] and [SETUP].
3.19. 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.
3.20. Reports Menu: Consists of 5 report types that can be displayed and these are:
3.20.1. Sensor Daily Details Report: Provides the user with up to 14 days of
individual data plots.
3.20.2. Sensor Data Report: A computerised logbook that presents all of the
data stored in the monitor memory for a patient download.
3.20.3. Sensor Modal Day Report: Represents all the glucose data over a 24hour period were each day is represented as a separate plot line in a
different colour.
3.20.4. Sensor Modal Time Periods Report: Provides an analysis of each of
the Time Range Blocks.
3.20.5. Sensor Summary Report: Includes a tabular summary of the
statistical data from the CGMS® and the glucose data that was entered
into the monitor.
3.21. SEL (Select) Button: To scroll through each of the displays and menus
available.
3.22. Sen-serter: Used to help insert the sensor through the skin and into the
subcutaneous tissue.
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.
Page 4 of 38
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/214_02
STANDARD OPERATING PROCEDURE
MEDTRONIC MINIMED CGMS®
SYSTEM GOLD™
Valid for:
2 years from
approval
3.24. 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.
3.25. 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 SOP/PD/214_02/A1 for further
details on each option.
3.26. 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.
3.27. Solutions™ Software: A computer programme designed to extract glucose
data from the Medtronic Minimed CGMS® System Gold™.
3.28. 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 SOP/PD/214_02/A2 for further details on how to use the test plug.
3.29. Up Button: To select between “No” and “Yes” commands and to find the next
highest preset value.
3.30. 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.
4.2.
The designated Laboratory Officer or Laboratory Assistant is responsible for
ensuring that this SOP is followed.
5. Procedure
5.1.
Set Up
5.1.1.
Monitor Set Up
Page 5 of 38
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/214_02
STANDARD OPERATING PROCEDURE
MEDTRONIC MINIMED CGMS®
SYSTEM GOLD™
5.1.1.1.
5.1.1.2.
5.1.1.3.
5.1.1.4.
5.1.1.5.
5.1.1.6.
5.1.1.7.
5.1.2.
Valid for:
2 years from
approval
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
SOP/PD/214_02/A1).
Press the ACT button whilst [EXIT] is displayed to exit the
Set Up menu and return to the Home Screen.
Sensor Insertion
5.1.2.1.
5.1.2.2.
5.1.2.3.
5.1.2.4.
5.1.2.5.
5.1.2.6.
5.1.2.7.
5.1.2.8.
5.1.2.9.
5.1.2.10.
5.1.2.11.
5.1.2.12.
5.1.2.13.
5.1.2.14.
5.1.2.15.
5.1.2.16.
5.1.2.17.
5.1.2.18.
5.1.2.19.
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 45o 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.
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 45o angle.
Dispose the introducer needle into a sharps container.
Page 6 of 38
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/214_02
STANDARD OPERATING PROCEDURE
MEDTRONIC MINIMED CGMS®
SYSTEM GOLD™
5.1.3.
Valid for:
2 years from
approval
Connecting the Cable
5.1.3.1.
Place the monitor connector end of the cable above the
monitor connection port until slight contact is made.
5.1.3.2. Align the arrow on the monitor connector with the arrow on
the monitor connection port.
5.1.3.3. Place the groove on the side of the cable tool on the
corresponding groove on the monitor connector.
5.1.3.4. Apply pressure to advance the monitor connector into the
monitor connection port.
5.1.3.5. Check that both arrows on the monitor connector and on the
monitor connection port are still properly aligned.
5.1.3.6. Grasp the sensor base between the thumb and forefinger.
5.1.3.7. Orient the sensor connector end of the cable to be in close
proximity to the connection of the sensor.
5.1.3.8. Plug the sensor connector end of the cable to the sensor.
5.1.3.9. Press both parts together until they snap in place.
5.1.3.10. Cover the insertion site with a transparent sterile dressing.
5.1.3.11. View the [ISIG] screen (see section 5.2.2) for 1-2 minutes to
ensure that the sensor current is adequate and stable.
5.1.4.
Sensor Initialisation
5.1.4.1.
5.1.4.2.
5.1.4.3.
5.1.4.4.
5.1.4.5.
5.1.4.6.
5.1.4.7.
5.1.4.8.
5.1.5.
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.
Sensor Calibration
5.1.5.1.
5.1.5.2.
Perform the first sensor calibration when
initialisation is complete.
Perform a finger stick glucose measurement.
Page 7 of 38
sensor
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/214_02
STANDARD OPERATING PROCEDURE
MEDTRONIC MINIMED CGMS®
SYSTEM GOLD™
5.1.5.3.
5.1.5.4.
5.1.5.5.
5.1.5.6.
5.1.5.7.
5.1.5.8.
5.1.6.
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
5.1.6.1.
5.1.6.2.
5.1.6.3.
5.1.7.
Valid for:
2 years from
approval
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.
5.1.7.2. Double click on the My Computer icon on the Windows
desktop.
5.1.7.3. Right click on the CD drive.
5.1.7.4. Click on Open.
5.1.7.5. Double click on the SETUP.EXE file.
5.1.7.6. Click the Next button.
5.1.7.7. Read the Software License Agreement.
5.1.7.8. Click the Yes button.
5.1.7.9. Click the Next button to accept the default destination
location for installation.
5.1.7.10. 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.
5.1.7.11. Click the Next button. The Select Program Folder window
will now be displayed.
5.1.7.1.
Page 8 of 38
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/214_02
STANDARD OPERATING PROCEDURE
MEDTRONIC MINIMED CGMS®
SYSTEM GOLD™
Valid for:
2 years from
approval
5.1.7.12. Click the Next button to accept the MiniMed Solutions
CGMS® Sensor software.
5.1.7.13. Click the Next button when the Start Copying Files window
is displayed.
5.1.7.14. Wait until the setup status reaches 100%.
5.1.7.15. 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.
5.1.7.16. The MiniMed Solutions CGMS® Sensor icon will now be
displayed on the Windows desktop.
5.1.8.
Setting Up the MiniMed Solutions CGMS® Sensor Programme
5.1.8.1.
5.1.8.2.
5.1.8.3.
5.1.8.4.
5.1.8.5.
5.1.8.6.
5.1.8.7.
5.1.8.8.
5.1.8.9.
5.1.8.10.
5.1.8.11.
5.1.8.12.
5.1.8.13.
5.1.8.14.
5.1.8.15.
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 ComStation port was selected, [Com-Station Ready] will be
displayed.
Click the Ok button.
If the wrong Com-Port was selected, [No 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.
Click outside of the time range block to save the changes
made.
Repeat steps 5.1.8.12 to 5.1.8.14 to change the time setting
of other time range blocks.
Page 9 of 38
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/214_02
STANDARD OPERATING PROCEDURE
MEDTRONIC MINIMED CGMS®
SYSTEM GOLD™
Valid for:
2 years from
approval
5.1.8.16. From the [Clinic Info] Menu, input the desired clinic name,
address and phone number.
5.1.8.17. 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.
5.1.9.
Connecting the Com-Station to the Computer
5.1.9.1.
5.1.9.2.
5.1.9.3.
5.1.9.4.
5.2.
Connect the computer cable into an available serial ComPort 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 ComStation.
Operation
5.2.1.
Recording Events in Monitor
5.2.1.1.
5.2.1.2.
5.2.1.3.
5.2.1.4.
5.2.1.5.
5.2.1.6.
5.2.2.
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
5.2.2.1.
5.2.2.2.
5.2.2.3.
5.2.2.4.
5.2.2.5.
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].
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.
Page 10 of 38
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/214_02
STANDARD OPERATING PROCEDURE
MEDTRONIC MINIMED CGMS®
SYSTEM GOLD™
5.2.3.
Entering and Editing Patient Information and Downloading Data
in Computer
5.2.3.1.
5.2.3.2.
5.2.3.3.
5.2.3.4.
5.2.3.5.
5.2.3.6.
5.2.3.7.
5.2.3.8.
5.2.3.9.
5.2.3.10.
5.2.3.11.
5.2.3.12.
5.2.3.13.
5.2.3.14.
5.2.3.15.
5.2.3.16.
5.2.3.17.
5.2.3.18.
5.2.3.19.
5.2.3.20.
5.2.3.21.
5.2.3.22.
5.2.3.23.
5.2.3.24.
5.2.4.
Valid for:
2 years from
approval
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.
Click the Save button when the Save As window is
displayed.
Displaying and Printing Report Results
5.2.4.1.
Open an existing patient file.
Page 11 of 38
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/214_02
STANDARD OPERATING PROCEDURE
MEDTRONIC MINIMED CGMS®
SYSTEM GOLD™
5.2.4.2.
5.2.4.3.
5.2.4.4.
5.2.4.5.
5.2.4.6.
5.2.5.
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
5.2.5.1.
5.2.5.2.
5.2.5.3.
5.2.5.4.
5.2.5.5.
5.2.5.6.
5.2.5.7.
5.2.5.8.
5.2.5.9.
5.2.5.10.
5.2.5.11.
5.2.5.12.
5.2.5.13.
5.2.5.14.
5.3.
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.
Maintenance
5.3.1.
Valid for:
2 years from
approval
Monitor Maintenance
Page 12 of 38
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/214_02
STANDARD OPERATING PROCEDURE
MEDTRONIC MINIMED CGMS®
SYSTEM GOLD™
5.3.1.1.
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.
5.3.1.2.
5.3.2.
Sen-serter Maintenance
5.3.2.1.
5.3.2.2.
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.
5.3.2.3.
5.3.2.4.
5.3.3.
Cable Maintenance
5.3.3.1.
Clean the outside surface using a moist cloth with a mild
cleaning agent
Disinfect using a moist cloth with 70% alcohol solution.
5.3.3.2.
5.4.
Valid for:
2 years from
approval
Troubleshooting
Alarm Message
[DISCONN-] displayed
-
Cause/s
Monitor is not
Page 13 of 38
-
Solution/s
Check sensor-to-cable and
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/214_02
STANDARD OPERATING PROCEDURE
MEDTRONIC MINIMED CGMS®
SYSTEM GOLD™
and alarm beeps every 15
seconds until
acknowledged.
Alarm will repeat every 5
minutes as long as
monitor continues not to detect a signal
detecting signal from
sensor
Sensor may be
disconnected from
monitor
Sensor may have
pulled out of
insertion site
-
-
[CAL ERR] displayed
and alarm beeps every 15
seconds until
acknowledged
The entered finger stick
blood glucose reading is
either higher or lower
than expected
-
-
[MEM FULL] displayed Memory used to store
and alarm beeps every 15 glucose data is > 90%
seconds until
full
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
minutes as long as sensor
current remains higher
than expected
-
Monitor detected sensor
current [ISIG] that is
significantly higher than
expected
-
-
-
-
Page 14 of 38
Valid for:
2 years from
approval
cable-to-monitor connections
Read the [ISIG] for 15
seconds
If [ISIG] value is > 5 and
remains fairly constant, wait
15 minutes and recalibrate
monitor before returning to
normal operation
If [ISIG] value is < 5 or
highly variable, perform Test
Plug Procedure (Refer to
SOP/PD/214_02/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
SOP/PD/214_02/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
SOP/PD/214_02/A1)
Press SEL than ACT to
switch alarm off
Take a finger stick glucose
measurement.
If reading > 400mg/dl (or >
22mmol/l), treat patient
accordingly and recalibrate
sensor once patient glucose
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/214_02
STANDARD OPERATING PROCEDURE
MEDTRONIC MINIMED CGMS®
SYSTEM GOLD™
Valid for:
2 years from
approval
levels become < 400mg/dl
-
[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
5.5.
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
Flow Charts
5.5.1.
Set Up – Monitor Set Up
Page 15 of 38
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
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/214_02
STANDARD OPERATING PROCEDURE
MEDTRONIC MINIMED CGMS®
SYSTEM GOLD™
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 SOP/PD/214_02/A1)
No
Need to exit Set Up
menu
Yes
Press ACT button whilst [EXIT] is
displayed in Set Up menu
5.5.2.
Set Up – Sensor Insertion
Start
Page 16 of 38
End
Valid for:
2 years from
approval
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/214_02
STANDARD OPERATING PROCEDURE
MEDTRONIC MINIMED CGMS®
SYSTEM GOLD™
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 45o angle
1
1
Press white button on Sen-serter
Page 17 of 38
Valid for:
2 years from
approval
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/214_02
STANDARD OPERATING PROCEDURE
MEDTRONIC MINIMED CGMS®
SYSTEM GOLD™
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 45o angle
Dispose introducer needle into
sharps container
End
5.5.3.
Set Up – Connecting the Cable
Start
Page 18 of 38
Valid for:
2 years from
approval
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/214_02
STANDARD OPERATING PROCEDURE
MEDTRONIC MINIMED CGMS®
SYSTEM GOLD™
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 5.5.10)
for 1-2 minutes to ensure that sensor
current is adequate and stable
End
5.5.4.
Set up – Sensor Initialisation
Page 19 of 38
Valid for:
2 years from
approval
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/214_02
STANDARD OPERATING PROCEDURE
MEDTRONIC MINIMED CGMS®
SYSTEM GOLD™
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
5.5.5.
Set Up – Sensor Calibration
Start
Page 20 of 38
Valid for:
2 years from
approval
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/214_02
STANDARD OPERATING PROCEDURE
MEDTRONIC MINIMED CGMS®
SYSTEM GOLD™
Valid for:
2 years from
approval
No
Sensor initialisation
complete
Wait for initialisation to be complete
Yes
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
No
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
Yes
Entered glucose value is outside the
sensitivity check expected ranges
Refer to section 5.4 for further details
End
5.5.6.
Set Up – Using the Monitor Belt Clip
Page 21 of 38
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/214_02
STANDARD OPERATING PROCEDURE
MEDTRONIC MINIMED CGMS®
SYSTEM GOLD™
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
No
Need to remove
belt clip
Yes
Lift grooved edge of belt clip
with thumb and gently slide
clip out of its groove
End
5.5.7.
Set Up – Installing the Solutions™ Software
Start
Page 22 of 38
Valid for:
2 years from
approval
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/214_02
STANDARD OPERATING PROCEDURE
MEDTRONIC MINIMED CGMS®
SYSTEM GOLD™
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 Yes button
Click Next button to accept default
destination location for installation
Use default
destination folder
to save patient
files
No
Yes
Click Next button
The Select Program Folder window
will now be displayed
Click Next button to
accept MiniMed Solutions
CGMS® Sensor software
1
1
Page 23 of 38
Click on Browse to
select another location
Valid for:
2 years from
approval
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/214_02
STANDARD OPERATING PROCEDURE
MEDTRONIC MINIMED CGMS®
SYSTEM GOLD™
Valid for:
2 years from
approval
Click Next button when Start Copying
Files window is displayed
Wait until setup status reaches 100%
No
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
Yes
End
5.5.8.
Start
Set Up – Setting up the MiniMed Solutions CGMS Sensor
Programme
Page 24 of 38
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/214_02
STANDARD OPERATING PROCEDURE
MEDTRONIC MINIMED CGMS®
SYSTEM GOLD™
Valid for:
2 years from
approval
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
No
No
Enter General
Tab Menu
Enter Reports
Tab Menu
2
Yes
Yes
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 the check box of the
Report type to be printed
No
Need to change
time range block
Click Check Com-Station button
2
Yes
No
[Com-Station
Ready] displayed
[No Com Station] will be displayed
to indicate that wrong
Com-Port was selected
Click on Time Range Block
that needs to be changed
Click Ok button
Click Ok button and
recheck connections
Click Up and Down arrows
to adjust time
Yes
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
No
Yes
1
1
Page 25 of 38
Need to change
Upper and/or
Lower limit/s of
default glucose
target
2
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/214_02
STANDARD OPERATING PROCEDURE
MEDTRONIC MINIMED CGMS®
SYSTEM GOLD™
Valid for:
2 years from
approval
No
Yes
No
2
Yes
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
5.5.9.
Set Up - Connecting the Com-Station to the Computer
Start
Page 26 of 38
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/214_02
STANDARD OPERATING PROCEDURE
MEDTRONIC MINIMED CGMS®
SYSTEM GOLD™
Valid for:
2 years from
approval
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
5.5.10. Operation – Recording Events and Reading Current and Voltage
Sensor Signals in Monitor
Page 27 of 38
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/214_02
STANDARD OPERATING PROCEDURE
MEDTRONIC MINIMED CGMS®
SYSTEM GOLD™
Valid for:
2 years from
approval
1
Start
Need to read
current and
voltage sensor
signals
No
Need to record
an event
Yes
No
Yes
Press SEL button twice
while in Home Screen
Press SEL button 3 times
while in Home Screen
[EVENT] will be displayed
[SIGNALS] will be displayed
Press ACT button
Press ACT button to display current,
in nA, together with [+ISIG]
No
Previous event had
already been
entered
Wait until the word
[EVENT] is flashing
Press SEL button whilst [ISIG] is
displayed to display voltage
Yes
Press SEL button to return
to [ISIG] display
Wait until the most recently
entered event is flashing
Press ACT button to
return to Home Screen
Press ACT button
Press Up and Down buttons to select
the desired event i.e. [FOOD],
[MEDS], [EXERCISE] and [OTHER]
End
1
5.5.11. Operation - Entering and Editing Patient Information and
Downloading Data in Computer
Start
Page 28 of 38
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/214_02
STANDARD OPERATING PROCEDURE
MEDTRONIC MINIMED CGMS®
SYSTEM GOLD™
Valid for:
2 years from
approval
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
No
Set default times
need to be
changed
Yes
Press On/Off switch of
Com-Station to switch it on
Check that monitor is switched on
and that it is displaying Home Screen
Yes
Use Up and Down arrow buttons to
change accordingly
No
Click on the desired Time Range
Block/s to be changed accordingly
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
1
Click Ok button when
[Download Complete] is displayed
Page 29 of 38
Select [Save As] from File Menu
Press Save button to save patient file
with its default name
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/214_02
STANDARD OPERATING PROCEDURE
MEDTRONIC MINIMED CGMS®
SYSTEM GOLD™
Valid for:
2 years from
approval
Yes
Yes
Press Ok button
Click Save button when [Save As]
window is displayed
5.5.12. Operation – Displaying and Printing Report Results and
Exporting Files
Start
Page 30 of 38
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/214_02
STANDARD OPERATING PROCEDURE
MEDTRONIC MINIMED CGMS®
SYSTEM GOLD™
Need to display a
report for a patient
No
No
Need to print data
Yes
Yes
Open an existing patient file
Select [Print] from File Menu
Click Print icon on
Sensor List Screen
Click on Reports Menu and choose
desired report to be viewed
Click Ok button
Wait until report is displayed
for the selected patient
No
Need to export file
Yes
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
2
The default location is: C:\Program
Files\ MiniMed Inc\
MiniMedSolutions
CGMS
Sensor\
Page 31
of 38
PatientData
1
Valid for:
2 years from
approval
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/214_02
STANDARD OPERATING PROCEDURE
MEDTRONIC MINIMED CGMS®
SYSTEM GOLD™
Click on .fst file
5.5.13. Maintenance
Page 32 of 38
Valid for:
2 years from
approval
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/214_02
STANDARD OPERATING PROCEDURE
MEDTRONIC MINIMED CGMS®
SYSTEM GOLD™
Valid for:
2 years from
approval
Start
[LOW BATT] or
[NO POWER]
displayed and
accompanying
alarm heard
No
Yes
Replace batteries
No
No
Monitor needs
cleaning
No
Sen-serter needs
cleaning
Yes
Cable needs
cleaning
Yes
Clean using a moist cloth with
a mild cleaning agent
Yes
Clean using moist cloth
with soapy water
Clean using moist cloth with
a mild cleaning agent
No
No
Sen-serter needs to
be disinfected
Yes
Yes
Disinfect using moist cloth with 10%
bleach or 70% alcohol solution
Allow to dry before use or storage
Store in released position to maintain
optimum product performance
6. Precautions
6.1.
Cable needs to be
disinfected
Sensor / Insertion Site Precautions
Page 33 of 38
Disinfect using moist cloth with
70% alcohol solution
End
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/214_02
STANDARD OPERATING PROCEDURE
MEDTRONIC MINIMED CGMS®
SYSTEM GOLD™
6.1.1.
6.1.2.
6.1.3.
6.1.4.
6.1.5.
6.1.6.
6.1.7.
6.1.8.
6.1.9.
6.1.10.
6.1.11.
6.1.12.
6.1.13.
6.1.14.
6.1.15.
6.1.16.
6.1.17.
6.2.
Valid for:
2 years from
approval
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
6.2.1.
6.2.2.
Do not use the monitor in close proximity of strong electromagnetic
sources such as medical imaging equipment, television and radio
transmitters.
Check that both the sensor and the monitor are securely fastened to the
patient before starting any form of exercise.
Page 34 of 38
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/214_02
STANDARD OPERATING PROCEDURE
MEDTRONIC MINIMED CGMS®
SYSTEM GOLD™
6.2.3.
6.2.4.
6.2.5.
6.2.6.
6.2.7.
Valid for:
2 years from
approval
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.
7. Reference
Medtronic MiniMed. CGMS® System Gold™ MMT-7102W user guide. Northridge
USA: Medtronic MiniMed; 2003.
8. Appendices
SOP/PD/214_02/A1 – Set Up Menu Table
SOP/PD/214_02/A2 – Test Plug Procedure Flow Chart
9. Revision History
Version Number
01
02
Amendments/ Reasons for change
Initial Release
Inclusion of subheading titles of
Procedure section in Table of Contents
Page 35 of 38
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/214_02
STANDARD OPERATING PROCEDURE
MEDTRONIC MINIMED CGMS®
SYSTEM GOLD™
Valid for:
2 years from
approval
SOP/PD/214_02/A1 – Set Up Menu Table
Display Symbol
Function
-
CLEAR
To clear the monitor
from all glucose results
history and calibration
data once all information
from monitoring period
has been downloaded to
a computer
-
PATIENT
To enter a patient’s
unique identification
number
-
INIT
To start sensor
initialisation period
-
SET TIME
To programme the
current time and date into
the monitor
-
Set-Up
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 [000-0000] 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 5.1.4
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
Page 36 of 38
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/214_02
STANDARD OPERATING PROCEDURE
MEDTRONIC MINIMED CGMS®
SYSTEM GOLD™
-
UNIT
To select between mg/dL
or mmol/L as the unit for
measuring blood glucose
-
LOCK
To prevent the set
parameters from being
altered by patient
-
EXIT
To exit the Set Up menu
and return to Home
Screen
-
Valid for:
2 years from
approval
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
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/214_02
STANDARD OPERATING PROCEDURE
MEDTRONIC MINIMED CGMS®
SYSTEM GOLD™
Valid for:
2 years from
approval
SOP/PD/214_02/A2 - Test Plug Procedure Flow Chart
Start
Disconnect cable from sensor
Connect test plug to cable
Read ISIG value
No
ISIG reading
between 24-29nA
Cable or monitor may be faulty
Yes
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
No
Initialise and recalibrate new sensor
ISIG reading
between 24-29nA
Monitor may be malfunctioned
Yes
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
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