standard operating procedure medtronic minimed cgms system gold

UNIVERSITY OF MALTA

FACULTY OF MEDICINE & SURGERY

PHARMACY DEPARTMENT

STANDARD OPERATING PROCEDURE

Ref. No.

SOP/PD/214_01

MEDTRONIC MINIMED CGMS

®

SYSTEM GOLD

™

Table of Contents

1.

Scope

2.

Objective

3.

Definitions

4.

Responsibility

5.

Procedure

6.

Precautions

7.

References

8.

Appendices

9.

Revision History

Page

6

34

35

35

35

2

2

2

5

Valid for:

2 years from approval

Original

Authorised Copy for:

Reading Copy

Written by:

Reviewed by:

Approved by:

Signature/Date:

Signature/Date:

Signature/Date:

Page 1 of 38






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SYSTEM GOLD

™

Ref. No.

SOP/PD/214_01

Valid for:


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.

AC Adapter Port: The location in which the power supply connection is connected to the Com-Station.

3.6.2.

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)

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3.6.3.

Device Selector Switch: Selects the data download source from either a continuous glucose monitor (the wave symbol) or a memory glucose meter (B symbol).

3.6.4.

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.

3.6.5.

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.

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3.15.

Memory: Stores up to 14 days of data which can then be transferred to a computer for further analysis.

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.

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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.

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_01/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_01/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.

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™

Ref. No.

SOP/PD/214_01

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5.

Procedure

5.1.

Set Up

5.1.1.

Monitor Set Up

5.1.1.1.

Insert 2 new AAA alkaline batteries into the battery compartment.

5.1.1.2.

Press the On/Off button to switch the monitor On.

5.1.1.3.

Wait until the monitor performs its routine diagnostic test and the Home Screen is displayed.

5.1.1.4.

Press the SEL button 4 times. [ SETUP ] will be displayed.

5.1.1.5.

Press the ACT button.

5.1.1.6.

Repeatedly press the SEL button to scroll through the 7 different options available in the Set Up menu (Refer to

SOP/PD/214_01/A1).

5.1.1.7.

Press the ACT button whilst [ EXIT ] is displayed to exit the

Set Up menu and return to the Home Screen.

5.1.2.

Sensor Insertion

5.1.2.1.

Wash hands well with soap and water.

5.1.2.2.

Wear a suitable pair of disposable gloves.

5.1.2.3.

Take out a sensor package from the refrigerator.

5.1.2.4.

Allow the sensor package to reach room temperature.

5.1.2.5.

Choose an appropriate sensor insertion site (see 3.24)

5.1.2.6.

Clean sensor insertion site with alcohol.

5.1.2.7.

Allow the sensor insertion site to dry completely before inserting a sensor.

5.1.2.8.

Remove the sensor from its packaging.

5.1.2.9.

Place the sensor in the Sen-serter.

5.1.2.10.

Hold the Sen-serter upright, secure the white tape of the sensor and remove the clear tape using an anticlockwise motion.

5.1.2.11.

Place fingers on the back of the white tape and push the carrier down until it clicks into place.

5.1.2.12.

Remove the needle guard from the introducer needle. o

5.1.2.13.

Rest the Sen-serter legs against the skin at a 45 angle.

5.1.2.14.

Press the white button on the Sen-serter.

5.1.2.15.

Check that the sensor has been inserted properly through the skin.

5.1.2.16.

Hold the sensor in place and gently slide the Sen-serter away from the sensor.

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5.1.2.17.

Remove the white paper from the adhesive pad and press it against the skin.

5.1.2.18.

Hold the sensor with two fingers on its base and gently remove the introducer needle at a 45 o

angle.

5.1.2.19.

Dispose the introducer needle into a sharps container.

5.1.3.

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.

Repeatedly press the SEL button, while in Home Screen, until [ SETUP ] is displayed.

5.1.4.2.


5.1.4.3.

Repeatedly press the SEL button until [ INIT ] is displayed.

5.1.4.4.

Press the ACT button. Monitor will beep and [ NO ] will flash.

5.1.4.5.

Press the Up or Down arrow button to select [ YES ].

5.1.4.6.

Press the ACT button to begin the initialisation process.

5.1.4.7.

Wait for one hour for the initialisation process to be complete. The monitor will continuously countdown the time remaining.

5.1.4.8.

Wait for the monitor to beep to indicate that the initialisation process is complete.

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5.1.5.

Sensor Calibration

5.1.5.1.

Perform the first sensor calibration when sensor initialisation is complete.

5.1.5.2.

Perform a finger stick glucose measurement.

5.1.5.3.

Press the SEL button once while in Home Screen. [ METER

BG ] is displayed.

5.1.5.4.

Press the ACT button and wait for [ --] and [ ENTER BG ] to be displayed.

5.1.5.5.

Use the Up and Down arrow buttons to enter the glucose measurement reading in increments of 1mg/dL (or

0.1mmol/L).

5.1.5.6.

Press the ACT button to confirm.

5.1.5.7.

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).

5.1.5.8.

Repeat sensor calibration procedure at least 4 times daily. A combination of fasting, preprandial and postprandial values are ideal.

5.1.6.

Using the Monitor Belt Clip

5.1.6.1.

Slide the triangular-shaped ridge on the back of the belt clip into its corresponding groove on the back of the monitor.

5.1.6.2.

Keep pushing the belt clip until it snaps into place.

5.1.6.3.

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.

5.1.7.

Installing the Solutions™ Software

5.1.7.1.

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.

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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.

5.1.7.12.

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.

Double click the MiniMed Solutions CGMS

®

Sensor icon on the Windows desktop.

5.1.8.2.

Check that the device selector switch of the Com-Station is in the wave symbol position.

5.1.8.3.

Select [ User Preferences ] from the File Menu.

5.1.8.4.

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.

5.1.8.5.

Click the [ Check Com-Station ] button. If correct Com-

Station port was selected, [ Com-Station Ready ] will be displayed.

5.1.8.6.

Click the Ok button.

5.1.8.7.

If the wrong Com-Port was selected, [ No Com-Station

Detected ] will be displayed. Click the Ok button and recheck the connections.

5.1.8.8.

Select between a 12-hour or a 24-hour time display option.

5.1.8.9.

Select between mg/dL or mmol/L from the [ Report Glucose

Units ] section.

5.1.8.10.

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.

5.1.8.11.

From the [ Reports ] Menu, click the checkbox of the Report that needs to be printed.

5.1.8.12.

Click on the time range block that needs to be changed.

5.1.8.13.

Click the Up and Down arrows to adjust its time.

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5.1.8.14.

Click outside of the time range block to save the changes made.

5.1.8.15.

Repeat steps 5.1.8.12 to 5.1.8.14 to change the time setting of other time range blocks.

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.

Connect the computer cable into an available serial Com-

Port connector on the computer.

5.1.9.2.

Connect the other end of the computer cable to Com-Port A of the Com-Station.

5.1.9.3.

Connect the AC adapter into a suitable power source.

5.1.9.4.

Connect the other end of the AC Adapter cable to the Com-

Station.

5.2.

Operation

5.2.1.

Recording Events in Monitor

5.2.1.1.

Press the SEL button twice while in Home Screen. [ EVENT ] will be displayed.

5.2.1.2.


5.2.1.3.

Wait until the word [ EVENT ] or the most recently entered event, if a previous event had been entered, is flashing.

5.2.1.4.


5.2.1.5.

Press the Up and Down buttons to select the desired event i.e. [ FOOD ], [ MEDS ], [ EXERCISE ] or [ OTHER ].

5.2.1.6.

Press the ACT button to accept the chosen event.

5.2.2.

Reading Current and Voltage Sensor Signals in Monitor

5.2.2.1.

Press the SEL button 3 times while in Home Screen.

[ SIGNALS ] will be displayed.

5.2.2.2.

Press the ACT button to display the current, in nanoamperes, in the upper right-hand corner of the screen, together with

[ + ISIG ].

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5.2.2.3.

Press the SEL button whilst [ ISIG ] is displayed to display the voltage, in volts, in the upper right-hand corner of the screen.

5.2.2.4.

Press the SEL button to return to [ ISIG ] display.

5.2.2.5.

Press the ACT button to return to the Home Screen.

5.2.3.

Entering and Editing Patient Information and Downloading Data in Computer

5.2.3.1.

Double click the MiniMed Solutions CGMS

®

Sensor icon on the Windows desktop.

5.2.3.2.

Select [ New Patient ] from the File menu.

5.2.3.3.

Enter the patient’s first and last name.

5.2.3.4.

Enter the patient’s ID number.

5.2.3.5.

Enter the name of the physician.

5.2.3.6.

Use the Up and Down arrow buttons if the Upper and Lower

Limits of the [ Glucose Target Range ] need to be changed.

5.2.3.7.

Click on any of the Time Range Blocks if the previously set default times need to be changed.

5.2.3.8.

Press the On/Off switch of the Com-Station to switch it on.

5.2.3.9.

Check that the monitor is switched on and that it is displaying the Home Screen.

5.2.3.10.

Place the monitor face up into the Com-Station cradle.

5.2.3.11.

Check that the monitor fits well in the cradle to ensure that the infrared communications ports are aligned.

5.2.3.12.

Select [ Download Glucose Monitor ] from the [ Download

Data ] Menu.

5.2.3.13.

Click the Download button to initiate the download.

5.2.3.14.

Wait until the status bar moves through its entire range.

5.2.3.15.

Click the Ok button when [ Download Complete ] is displayed.

5.2.3.16.

Select [ Save As ] from the File Menu.

5.2.3.17.

Press the Save button to save the patient file with its default name (i.e. last name, first initial, patient ID and date).

5.2.3.18.

Select [ Open Existing Patient ] from the File Menu to open and/or edit an existing patient file.

5.2.3.19.

Select the patient file that needs to be opened.

5.2.3.20.

Click the Open button.

5.2.3.21.

The Patient Entry and Edit screen will be displayed containing information about the patient.

5.2.3.22.

Select [ Rename Patient File ] from the File Menu if the first name, second name or patient ID needs to be changed.

5.2.3.23.


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5.2.3.24.

Click the Save button when the Save As window is displayed.

5.2.4.

Displaying and Printing Report Results

5.2.4.1.

Open an existing patient file.

5.2.4.2.

Click on the Reports Menu and choose the desired report to be viewed.

5.2.4.3.

Wait until the report is displayed for that selected patient.

5.2.4.4.

Select [ Print ] from the File Menu if report is to be printed.

5.2.4.5.

Click the Print button on the Sensor List Screen.

5.2.4.6.


5.2.5.

Exporting Files

5.2.5.1.

Close any reports that may be open.

5.2.5.2.

Select [ Export File ] from the File Menu. The Save As window will be displayed.

5.2.5.3.

Check that the correct patient file is being exported.

5.2.5.4.

Click the Save button.

5.2.5.5.

Open the desired programme you want to use to view the data.

5.2.5.6.

Select [ Open ] from this programme’s File Menu.

5.2.5.7.

Locate the .fst file. The default location is: C:\ Program

Files\ MiniMed Inc\ MiniMedSolutions CGMS Sensor\

PatientData.

5.2.5.8.

Click on the .fst file to be opened.

5.2.5.9.

Click the Open button. The Text Import Wizard window will be displayed.

5.2.5.10.

Check that [ Delimited ] is selected.

5.2.5.11.


5.2.5.12.

Select the [ Other ] text box and type in [ | ].

5.2.5.13.


5.2.5.14.

Click the Finish button.

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5.3.

Maintenance

5.3.1.

Monitor Maintenance

5.3.1.1.

Replace batteries if [ LOW BATT ] or [ NO POWER ] is displayed and accompanying alarm is heard.

5.3.1.2.

Clean the outside surface using a moist cloth with a mild cleaning agent.

5.3.2.

Sen-serter Maintenance

5.3.2.1.

Clean using a moist cloth with soapy water.

5.3.2.2.

Disinfect using a moist cloth with 10% bleach or 70% alcohol solution.

5.3.2.3.

Allow to dry before use or storage.

5.3.2.4.

Store in the released position to maintain optimum product performance.

5.3.3.

Cable Maintenance

5.3.3.1.

Clean the outside surface using a moist cloth with a mild cleaning agent

5.3.3.2.

Disinfect using a moist cloth with 70% alcohol solution.

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[

[

[

5.4.

Troubleshooting

Alarm Message

[ DISCONN-] displayed and alarm beeps every 15 seconds until

Cause/s

Monitor is not detecting signal from acknowledged.

Alarm will repeat every 5 minutes as long as monitor continues not to detect a signal sensor

Sensor may be disconnected from monitor

Sensor may have pulled out of insertion site

CAL ERR

ISIG HI

] is > 90% full displayed and alarm beeps every 15 seconds until acknowledged

MEM FULL seconds until seconds until

] displayed and alarm beeps every 15 acknowledged.

Alarm will repeat every 6 hours as long as memory

] displayed and alarm beeps every 15 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

Solution/s

Check sensor-to-cable and 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_01/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_01/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_01/A1)

Press SEL than ACT to switch alarm off

Take a finger stick glucose measurement.

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2 years from approval minutes as long as sensor current remains higher than expected

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

[ LOW BATT ] displayed and alarm beeps once.

Alarm will repeat every hour until batteries are replaced or loose all power

Batteries have only about

72 hours of remaining power

[ NO POWER ] displayed Batteries are only expected to last less than one hour

Diagnostic test detected [ E-OX ] displayed and alarm beeps every 10 seconds until data is downloaded to pc an error in the memory programme

Immediately install new batteries and recalibrate sensor

Immediately download all data from monitor while this is switched on and then replace monitor

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5.5.

Flow Charts

5.5.1.

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 SOP/PD/214_01/A1)

Need to exit Set Up menu

Yes

Press ACT button whilst [ EXIT ] is displayed in Set Up menu

No

Page 16 of 38

End






®

SYSTEM GOLD

™

Ref. No.

SOP/PD/214_01

Valid for:


5.5.2.

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






®

SYSTEM GOLD

™

Ref. No.

SOP/PD/214_01

Valid for:


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






®

SYSTEM GOLD

™

Ref. No.

SOP/PD/214_01

Valid for:


5.5.3.

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 5.5.10) for 1-2 minutes to ensure that sensor current is adequate and stable

End

Page 19 of 38






®

SYSTEM GOLD

™

Ref. No.

SOP/PD/214_01

Valid for:


5.5.4.

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






®

SYSTEM GOLD

™

Ref. No.

SOP/PD/214_01

Valid for:


5.5.5.

Set Up – Sensor Calibration

Start

Sensor initialisation complete

No

Yes

Perform first sensor calibration

Perform a finger stick

glucose measurement

Press SE L 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

Yes

Entered glucose value is outside the sensitivity check expected ranges

Refer to section 5.4 for further details

No

End

Wait for initialisation to be complete

Repeat sensor calibration procedure at least 4 times daily incorporating a combination of fasting, pre-prandial and post-prandial values

Page 21 of 38






®

SYSTEM GOLD

™

Ref. No.

SOP/PD/214_01

Valid for:


5.5.6.

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

Yes

Lift grooved edge of belt clip with thumb and gently slide clip out of its groove

No

End

Page 22 of 38






®

SYSTEM GOLD

™

Ref. No.

SOP/PD/214_01

Valid for:


5.5.7.

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 Yes button

Click Next button to accept default destination location for installation

Yes

Use default destination folder to save patient files

Click Next button

The Select Program Folder window will now be displayed

Click Next button to accept MiniMed Solutions

CGMS

®

Sensor software

1

No

Page 23 of 38

Click on Browse to select another location






®

SYSTEM GOLD

™

Ref. No.

SOP/PD/214_01

Valid for:


1

Click Next button when Start Copying

Files window is displayed

Wait until setup status reaches 100%

Yes

Reboot request message displayed

Accept request to finish installation process

No

Click Finish button when Setup

Complete window is displayed

MiniMed Solutions CGMS

®

Sensor icon will now be displayed on Windows desktop

End

Page 24 of 38





Ref. No.

SOP/PD/214_01


SYSTEM GOLD

™

® Valid for:


Start

5.5.8.

Set Up – Setting up the MiniMed Solutions CGMS Sensor

Programme

Double click MiniMed Solutions

CGMS

®

Sensor icon on desktop

Yes

Check that device selector switch of Com-Station is in

the wave symbol position

Select [ User Preferences ] from File Menu

Enter General

Tab Menu

No

Yes

Enter Reports

Tab Menu

No

2

Click [ General ] 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

No

[ Com-Station

Ready ] displayed

Yes

Click Ok button

Select between a 12-hr or 24-hr time display option

Select between mg/dL or mmol/L from [ Report Glucose Units ] section

1

[ No Com Station ] will be displayed to indicate that wrong

Com-Port was selected

Click Ok button and recheck connections

Yes

Click [ Reports ] Tab

Click the check box of the

Report type to be printed

Need to change time range block

Click on Time Range Block

that needs to be changed

Click Up and Down arrows to adjust time

Click outside of time range block

to save changes made

Change more time range blocks

Yes

No

No

2

2

Page 25 of 38






®

SYSTEM GOLD

™

Ref. No.

SOP/PD/214_01

Valid for:


2

Need to change

Upper and/or

Lower limit/s of default glucose target

Yes

Use the Up and Down arrow

buttons respectively

Yes

1

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

No

No

Page 26 of 38






®

SYSTEM GOLD

™

Ref. No.

SOP/PD/214_01

Valid for:


5.5.9.

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





Ref. No.

SOP/PD/214_01


SYSTEM GOLD

™

® Valid for:


Yes

Start

5.5.10.

Operation – Recording Events and Reading Current and Voltage

Sensor Signals in Monitor

1

No

No

Need to record

an event

Press SEL button twice while in Home Screen

Yes

Need to read current and voltage sensor signals

Press SEL button 3 times while in Home Screen

[ EVENT ] will be displayed

Press ACT button

Yes

Previous event had already been entered

Wait until the most recently entered event is flashing

Press ACT button

Press Up and Down buttons to select the desired event i.e. [ FOOD ],

[ MEDS ], [ EXERCISE ] and [ OTHER ]

No

Wait until the word

[ EVENT ] is flashing

[ SIGNALS ] will be displayed

Press ACT button to display current, in nA, together with [ +ISIG ]

Press SEL button whilst [ ISIG ] is displayed to display voltage

Press SEL button to return

to [ ISIG ] display

Press ACT button to return to Home Screen

End

1

Page 28 of 38





Ref. No.

SOP/PD/214_01


SYSTEM GOLD

™

® Valid for:


5.5.11.

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

Yes

Enter name of physician

Need to change

Upper and/or

Lower Limits of glucose target range

No

Yes

Set default times need to be changed

Click on the desired Time Range

Block/s to be changed accordingly

No

Press On/Off switch of

Com-Station to switch it on

Check that monitor is switched on and that it is displaying Home Screen

Use Up and Down arrow buttons to change 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

Page 29 of 38






®

SYSTEM GOLD

™

Ref. No.

SOP/PD/214_01

Valid for:


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

Yes

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

Yes

Select [ Rename Patient File ] from File Menu

No

Edit the information in the

[ Rename Patient File ] window

Press Ok button

Click Save button when [ Save As] window is displayed

End

No

Page 30 of 38





Ref. No.

SOP/PD/214_01


SYSTEM GOLD

™

® Valid for:


Yes

5.5.12.

Operation – Displaying and Printing Report Results and

Start

Exporting Files

Need to display a report for a patient

Open an existing patient file

No

Yes

Need to print data

Select [ Print ] from File Menu

No

Click on Reports Menu and choose desired report to be viewed

Click Print icon on

Sensor List Screen

Click Ok button

Wait until report is displayed for the selected patient

No

Yes

Need to export file

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

1

Page 31 of 38






®

SYSTEM GOLD

™

Ref. No.

SOP/PD/214_01

Valid for:


1

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

Click Finish button

End

Page 32 of 38





Ref. No.

SOP/PD/214_01


®

SYSTEM GOLD

™

5.5.13.

Maintenance

Start

[ LOW BATT ] or

[ NO POWER ] displayed and accompanying alarm heard

Yes

Replace batteries

Monitor needs cleaning

Yes

Clean using a moist cloth with

a mild cleaning agent

No

No

Yes

Yes

Sen-serter needs cleaning

Clean using moist cloth with soapy water

Sen-serter needs to be disinfected

Disinfect using moist cloth with 10% bleach or 70% alcohol solution

No

No

Allow to dry before use or storage

Store in released position to maintain optimum product performance

Yes

Valid for:


Cable needs cleaning

Clean using moist cloth with

a mild cleaning agent

Yes

Cable needs to be disinfected

Disinfect using moist cloth with

70% alcohol solution

End

No

No

Page 33 of 38






®

SYSTEM GOLD

™

Ref. No.

SOP/PD/214_01

Valid for:


6.

Precautions

6.1.

Sensor / Insertion Site Precautions

6.1.1.

Do not use a sensor if the temperature-limit indicator on its storage box is black in colour.

6.1.2.

Do not use sensor if its package has been already opened or damaged.

6.1.3.

Avoid touching any sensor surfaces that will eventually come in contact with the inside of the body.

6.1.4.

Check that the sensor is securely placed in the Sen-Serter prior to insertion since this may result in pain and minor injury.

6.1.5.

Do not point a loaded Sen-serter towards any body part where insertion is not desired.

6.1.6.

Do not twist, bend or lift the Sen-serter while removing it from the sensor.

6.1.7.

Select a new insertion site that is at least 5cm from the previous insertion site each time a new sensor is to be inserted.

6.1.8.

Do not insert sensors in locations that are constrained by clothing or are subjected to rigorous movements.

6.1.9.

Avoid sensor insertion in the area of the waistline, around navel and in scarred or atrophied tissue

6.1.10.

For users who inject insulin, instruct patient or carer to administer the injections at least 8 cm away from the sensor insertion site.

6.1.11.

For users who wear an insulin pump, ensure that the sensor insertion site is at least 5 cm away from the insulin infusion site.

6.1.12.

Do not rotate the introducer needle while it is being removed.

6.1.13.

Periodically check the insertion location for any redness, bleeding, pain, tenderness and swelling and to ensure that the sensor remained in place.

6.1.14.

Advise the patient to check the sensor regularly especially before going to bed and after waking up.

6.1.15.

Infection and/or site irritation may result from improper insertion of the sensor at the insertion site.

6.1.16.

Enter sensor calibration values immediately within 5 minutes of obtaining a fingerstick glucose value.

6.1.17.

Recalibrate the sensor whenever the sensor is disconnected and reconnected again.

6.2.

Monitor precautions

6.2.1.

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






®

SYSTEM GOLD

™

Ref. No.

SOP/PD/214_01

Valid for:


6.2.2.

Check that both the sensor and the monitor are securely fastened to the patient before starting any form of exercise.

6.2.3.

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.

6.2.4.

Keep the monitor in its original case while it is in use to protect it against bumps and scratches of everyday use.

6.2.5.

Whilst changing batteries, do not leave the monitor for more than 5 minutes without batteries to avoid losing glucose data and programme information.

6.2.6.

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.

6.2.7.

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.

References

Medtronic MiniMed. CGMS

®

System Gold

™

MMT-7102W user guide. Northridge

USA: Medtronic MiniMed; 2003.

8.

Appendices

SOP/PD/214_01/A1 – Set Up Menu Table

SOP/PD/214_01/A2 – Test Plug Procedure Flow Chart

9.

Revision History

Version Number

01

Amendments/ Reasons for change

Initial Release

Page 35 of 38






®

SYSTEM GOLD

™

SOP/PD/214_01/A1 – Set Up Menu Table

Ref. No.

SOP/PD/214_01

Valid for:


Display Symbol

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

Function 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 To start sensor initialisation period

To programme the current time and date into the monitor

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

UNIT

LOCK

EXIT






®

SYSTEM GOLD

™

Ref. No.

SOP/PD/214_01

Valid for:


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

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 To exit the Set Up menu and return to Home

Screen

Page 37 of 38






®

SYSTEM GOLD

™

SOP/PD/214_01/A2 - Test Plug Procedure Flow Chart

Ref. No.

SOP/PD/214_01

Valid for:


Start

Disconnect cable from sensor

Connect test plug to cable

Read ISIG value

No

ISIG reading between 24-29nA

Yes

Sensor no longer useful / has been pulled out of insertion site or sensor connector may have gotten wet

Remove old sensor and insert new one

Initialise and recalibrate new sensor

Cable or monitor may be faulty

Disconnect cable from monitor

Yes

Replace cable with test plug

Read ISIG value

ISIG reading between 24-29nA

Cable may be malfunctioned

Disconnect test plug from monitor

Plug in a new cable to monitor

Remove old sensor and

insert a new one

No

Monitor may be malfunctioned

Call supplier

Connect new cable to sensor

Initialise and calibrate new sensor

End

Page 38 of 38

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