Medtronic A810 Programming Guide

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SynchroMed™ II

Clinician Programmer

Clinician Programming Guide

A810

SynchroMed

Includes information about the Model A901 Communication Manager app and the Model A902 Patient Data Service app

Application version 1.1

™

II infusion systems

QUICK APPLICATION OVERVIEW

HOME and Settings buttons

Task menu - Tap to access additional screens or navigate

Selected workow

Workow navigator

Tap to change infusion modes

Edit button - Tap to

edit an element or

value

Previous / Next buttons

Alerts button

Figure 1. Quick Application Overview

SCREEN OVERVIEW

These features are shown in Figure 1.

Screen Overview Description

Workow - After reviewing current pump settings, the user must choose a workow. Workows contain a series of screens used to complete programming tasks. See “Workows” on page 19.

Navigation - Users can navigate through the app by swiping left or right, tapping the task in the workow navigator, tapping the PREVIOUS and NEXT buttons, or selecting tasks using the task menu button. See “Navigation” on page 20.

Finish screen - The Finish screen is the last screen in every workow and contains a side-by-side comparison of all program settings.

The user must review all settings to conrm pending changes prior to updating the pump. See “FINISH SCREEN” on page 42.

Action bar - The action bar runs along the top of all screens and contains buttons and indicators. See “Action Bar” on page 20.

■ Task menu button (

■ HOME button (

■ Settings button (

Editing an element - There are a few different types of editable elds; some values may be updated using a dropdown menu while other values are edited by tapping the input box and using a keypad to edit. Tapping the edit button (

) - Tap to access additional screens or navigate

) - Tap to return to the Home screen

) - Tap to open a menu that includes additional options.

) puts an element in edit mode.

Label Symbols

Explanation of symbols in this manual.

Conformité Européenne (European Conformity). This symbol means that the device fully complies with AIMD Directive 90/385/EEC (NB 0123).

Authorized Representative in the European Community

Manufacturer

For USA audiences only

Trademarks

Medtronic and Medtronic logo are trademarks of Medtronic. Third party brands are trademarks of their respective owners. All other brands are trademarks of a Medtronic company.

Refer to the appropriate indications, drug stability, and emergency procedures manual for indications and related information.

Refer to the appropriate drug labeling for indications, contraindications, warnings, precautions, dosage and administration information, and screening procedures.

Refer to the device implant manual for device description, package contents, device specications, and

instructions for use.

Refer to the literature provided by the clinician tablet manufacturer for information regarding wireless

use.

Communicating via BLUETOOTH® after pairing .............................16

Communicator status on clinician tablet .......................................... 16

DEVICE DESCRIPTION ...................................... 9

Model 8880T2 Communicator ........................................ 9

Model A901 Communication Manager App ....................9

Model A902 Patient Data Service App ............................9

Abbreviations and Terminology.......................................9

DATA SECURITY AND NETWORK

CONNECTIVITY ................................................ 10

Data Security ................................................................ 10

Network connectivity ..................................................... 10

Installing application updates ....................................... 11

Returning the clinician tablet ........................................ 11

PROGRAMMER SETUP ................................... 11

The Clinician Programmer App ..................................... 11

Main Menu Screen ....................................................... 11

When the app is in the background ................................................. 12

Preparing the Tablet for Programming .......................... 13

Communicator Preparation ........................................... 14

USB connector cable - when to use ................................................ 14

Installing updates to the communicator ........................................... 14

Communicator icons in tablet status bar .........................................15

HOME SCREEN ................................................ 17

Pump Time ...................................................................17

Re-Interrogate .............................................................. 17

Active Alarms ................................................................ 17

Workows ..................................................................... 19

PROGRAMMING SCREENS ............................ 19

Screen Features ........................................................... 19

Navigation ..................................................................... 20

Action Bar ..................................................................... 20

Settings ...........................................................................................20

PATIENT SCREEN ............................................ 22

PUMP SCREEN ................................................ 23

CATHETER SCREEN ....................................... 23

DRUGS SCREEN .............................................. 24

RESERVOIR SCREEN ..................................... 25

INFUSION SCREEN ......................................... 26

Pairing the Communicator with a Clinician Tablet and

Interrogating the Pump ................................................. 15

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Selecting an Infusion Mode .......................................... 26

Dose/Rate Panel .......................................................... 28

Infusion Display Panel .................................................. 28

Screen Elements .......................................................... 28

Conguring a Pattern .................................................... 30

Conguring a Weekly Plan ........................................... 31

ENDING A SESSION ........................................ 45

DEMO MODE .................................................... 47

DRUG LIBRARY ...............................................47

BOLUS SCREEN .............................................. 31

Recommended bolus .................................................... 32

Setting up a Prime Bolus .............................................. 32

Setting up a Bridge Bolus ............................................. 35

Setting up a Single Bolus ............................................. 36

Setting up a Roller Study .............................................. 36

Canceling or Continuing a Bolus in Progress ............... 37

MYPTM™ SCREEN .......................................... 38

Programming the Pump for Patient-Activated Dosing .. 38

ALARMS SCREEN ........................................... 40

DISCONTINUE SCREEN .................................. 41

Permanently Shutting Down a Pump ............................ 41

Shutting Down an Unusable Pump ............................... 42

FINISH SCREEN ............................................... 42

Reviewing Changes ...................................................... 42

Updating the Pump ....................................................... 43

If telemetry is interrupted during a pump update ............................. 45

REPORTS ......................................................... 48

ALERTS ............................................................ 49

PATIENT DATA SERVICE APP ........................ 50

PDF Auto-Delete Feature .............................................50

TROUBLESHOOTING ...................................... 50

Pump Troubleshooting .................................................. 50

Communicator Troubleshooting .................................... 50

DEVICE LONGEVITY ....................................... 52

PUMP ACTIVITY LOGS .................................... 53

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DEVICE DESCRIPTION

The Medtronic Model A810 SynchroMed™ II Clinician Programmer application (app) is intended for use by clinicians in the programming of the Model 8637 SynchroMed II Programmable Pump for intrathecal applications. This manual contains information for clinicians in programming and troubleshooting the

SynchroMed II Infusion system.

The clinician tablet, the communicator, the Patient Data Service app, and the Communication Manager app are required to use the A810 SynchroMed II Clinician Programmer application.

Model A902 Patient Data Service App

The Model A902 Patient Data Service app is intended for use by clinicians to access reports for patients whose Medtronic devices have been programmed using the clinician programmer apps on the clinician tablet.

For instructions on using the Patient Data Service app, refer to “PATIENT DATA SERVICE APP” on page 50.

Abbreviations and Terminology

Model 8880T2 Communicator

Caution: Do not attempt telemetry near equipment that

may generate electromagnetic interference (EMI) such as radio frequency identication (RFID) equipment. EMI can interfere with telemetry during programming. If EMI disrupts programming, move the programming components away from the likely source of EMI.

The Model 8880T2 Communicator is intended for use by clinicians to use in conjunction with the clinician tablet and clinician programmer app for telemetry communication with Medtronic Neuromodulation implantable therapy devices.

Refer to the Model 8880T2 Communicator Technical Manual for operating instructions and specications.

Model A901 Communication Manager App

The Model A901 Communication Manager App manages telemetry communication between the clinician tablet, communicator, and infusion pump.

Table 1. Abbreviations used in this manual

Abbreviation Denition

App Software application

Demo mode Demonstration mode

ERI Elective replacement indicator

EOS End of service indicator

LED Light-emitting diode

USB connector cable

Universal serial bus connector cable

Table 2. Terminology used in this manual

Term Description

Action Bar The top row containing buttons and

indicators on the clinician programmer app screen when in a workow.

Clinician Programmer App

The Medtronic therapy software application intended for clinicians to program Medtronic devices.

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DEVICE DESCRIPTION

Term Description

Tablet or Clinician Tablet

Tablet Status Bar The top-most row of indicators on the

The tablet hardware and operating system.

tablet screen. The tablet status bar is not a part of the clinician programmer app.

DATA SECURITY AND NETWORK CONNECTIVITY

Data Security

The clinician programming system uses and stores data about the patient’s health and implanted medical device. This data is protected by application-level encryption and encryption provided by the clinician tablet. The clinician programming system does not provide data protection for data exported to another destination. Exported data should be handled in accordance with your facility’s security policy for data handling and storage.

■ Medtronic recommends that you always save exported data to the default reports location on the clinician tablet.

Network connectivity

Network connectivity is required for initial app registration and for installation of Medtronic app updates and communicator rmware updates. Network connectivity is not required for pump programming. To protect your clinician programming system, Medtronic recommends you implement the following security measures:

■ Secure your clinician tablet by disabling network connectivity during any programming session.

■ Use a managed, trusted Wi-Fi connection when network connectivity is needed.

■ Connect the clinician tablet to the network periodically to check for update notications.

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DA TA SECURITY AND NETWORK CONNECTIVITY

Caution: Connecting the clinician tablet to a network that

includes other equipment could result in unforeseen risks to patients, operators, or third parties. Changes to your network such as adding, disconnecting, and upgrading equipment; upgrading or installing software; or changing network congurations could also introduce additional risks. Analyze, evaluate, and control any identied risks.

If you suspect a cybersecurity event has occurred, stop using the app (if possible) and contact your IT Security team or Medtronic Technical Services to document and respond to the suspected

incident.

If your clinician tablet is lost or stolen, contact Medtronic Technical Services or your Medtronic representative. See the Troubleshooting section or the back cover for contact information.

Installing application updates

Medtronic periodically updates the therapy app and will not install updates without notifying the user. Network connectivity is required to update the app. When notied that an app update is available, follow the instructions provided by Medtronic to install it.

Returning the clinician tablet

If you need to return the clinician tablet for disposal or replacement, contact Medtronic Technical Services or your Medtronic representative. See the Troubleshooting section or the back cover for contact information. Instructions will be provided for preparing the clinician tablet for return.

PROGRAMMER SETUP

The Clinician Programmer App

Note: In this manual, gures of the app screens are examples.

What is displayed on the actual screens may differ.

To nd and open the app

1. Navigate to Apps on the clinician tablet.

2. Find the SynchroMed II app icon (Figure 2).

Figure 2. SynchroMed II app icon

3. Tap the SynchroMed II app icon to open. The main menu

screen is displayed.

Main Menu Screen

The SynchroMed II app opens onto the main menu screen. The application will return to this screen when a session is ended. On the main menu screen:

■ Tap DEMO to use Demo mode.

■ Tap CONNECT to start a session with a pump.

■ Tap REPORTS to view reports for a patient without having

to start a session.

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PROGRAMMER SETUP

When the app is in the background

When you navigate away from the clinician programmer app while in a session, the app is placed in the background and is represented as a oating widget on the tablet.

The oating widget is an overlay that oats on top of the screen to remind you that you are still in a programming session.

■ Press and drag the oating widget to move it on the tablet

screen.

■ Tap on the oating widget to access the app and resume

the session.

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PROGRAMMER SETUP

System Components

Clinician tablet with clinician

programmer app

The USB connector cable is required

when pairing the communicator to

the clinician tablet. After pairing,

communication can occur via USB

connector cable or BLUETOOTH.

After pairing, the communicator and the clinician

tablet with the clinician programmer app can

communicate wirelessly via the BLUETOOTH wireless

USB connector cable Communicator

Move the Communicator

over the implanted device

and tap CONNECT on the

Clinician Programmer

BLUETOOTH

technology.

Figure 3. Components for programming the pump

SynchroMed II Pump

Telemetry

Software Application.

Preparing the Tablet for Programming

Caution: Do not use multiple programmers simultaneously

during the same programming session. The consequences of using multiple programmers simultaneously within the same programming session is unknown.

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Before starting a programming session:

■ Check the clinician tablet battery status and ensure the appropriate clinician programmer app has been installed.

– The tablet’s battery level is shown on the tablet

status bar (top-most row of indicators on the tablet).

– Recharge the tablet if the battery level is low.

PROGRAMMER SETUP

■ Check the communicator battery status. Change batteries if the LED light for the communicator battery level indicator on the communicator is amber or ashing red.

■ Conrm that the clinician tablet is paired to the correct communicator.

■ A communicator must be paired to the clinician tablet before an implantable device can be found and a programming session can start.

■ After the communicator has been paired with the clinician tablet using the USB connector cable, BLUETOOTH wireless communication between the communicator and the clinician tablet can be used.

■ If the communicator is not connected to the clinician tablet with the USB connector cable, the clinician tablet attempts to communicate via BLUETOOTH wireless technology to the communicator that was last used with the clinician tablet.

■ The communicator can only remain paired with one clinician tablet at a time.

■ If you need more detailed information about the communicator (e.g. how to connect the USB connector cable and information about the Communicate button and LED indicators), refer to the Model 8880T2 Communicator Technical Manual.

Communicator Preparation

Check the battery level of the communicator before updating or communicating with the pump.

The following describes the colors used for the battery LED indicator (on the top right side of the communicator):

■ Green for 10 seconds: Communicator has been turned on. Battery level is acceptable and all communicator functions are enabled.

■ Amber: Communicator has been turned on. Batteries should be replaced soon.

■ Flashing red: Communicator has been turned on. Batteries should be replaced immediately.

For communicator troubleshooting instructions, refer to “Communicator Troubleshooting” on page 50.

USB connector cable - when to use

The following situations require the use of the USB connector cable:

■ First-time pairing of the communicator to a clinician tablet.

■ Firmware updates to the communicator.

■ Environments where multiple devices are using

BLUETOOTH wireless technology and creating

interference.

■ Environments where BLUETOOTH wireless technology is

prohibited.

Installing updates to the communicator

If you receive a notication of an update for the communicator:

■ Use the USB connector cable to install the update from the clinician tablet to the communicator.

■ Install the update in advance of a programming session. The update will take several minutes to complete.

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PROGRAMMER SETUP

Communicator icons in tablet status bar

Table 3 shows the icons that appear in the clinician tablet status bar (top-most row) indicating communicator communication status with the clinician tablet.

Table 3. Communicator icons in tablet status bar

Icon Details

The communicator is in the process of connecting to the clinician tablet.

The communicator is communicating with the clinician tablet via the USB connector cable.

The communicator requires the USB connector cable to communicate with the clinician tablet.

The communicator is communicating with the clinician tablet via BLUETOOTH wireless technology.

3. On the pop-up message that appears, which asks to open the Communication Manager app when the USB device is

connected:

a. Tap to use the USB device by default. This selection

prevents this pop-up message from appearing again.

b. Tap OK.

4. From the initial screen, tap CONNECT. Pairing commences and the following LED lights will display green on the communicator:

– LED light between the tablet icon and the

communicator icon will be a solid green.

– LED arrow lights on the Communicate button will

ash green indicating that you can interrogate the device.

At this point, the communicator is paired with the clinician tablet and subsequent use of the communicator with the clinician tablet can use the BLUETOOTH wireless technology.

Pairing the Communicator with a Clinician Tablet and Interrogating the Pump

A Communicator must be paired to the programmer before a session can be started with an implantable device.

To pair the communicator with a clinician tablet

1. Connect the USB connector cable to the communicator and the clinician tablet.

2. Ensure the communicator is turned on (slide the Power button, then release).

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To interrogate a pump

Caution: Check the power status of the programmer and

communicator before starting a programming session. Loss of power during a programming session will restart the programmer and can lead to a loss of pending changes.

Warning: To use the nonsterile programmer system

components in a sterile eld, place a sterile barrier between the patient and system components to prevent infection. Do not sterilize any components of the programmer system. Sterilization may damage the components.

Warning: Before interrogating or updating the pump, conrm

that the time and date on the programmer are correct. Incorrect time and date can result in incorrect programming and estimated dates.

PROGRAMMER SETUP

1. Open the SynchroMed II app.

2. Tap CONNECT on the main menu screen.

3. Place the communicator over and as close as practical to the implantable pump.

Note: The target symbol on the back of the communicator indicates the location of the internal antenna. The target should be facing and centered over the implantable device.

Warning: To ensure successful telemetry, hold the

communicator steady over the implanted pump until conrmation is received that telemetry was successful. If the communicator is not held over the pump properly, telemetry may not be established or may be interrupted, which can result in unintended or incomplete programming.

4. Progress is displayed while communication with the implantable device is established.

5. The HOME screen is displayed with the current system settings (refer to Figure 4 on page 18).

Note: Do not leave the clinician tablet unattended during an active programming session. End the session properly by tapping the Settings button (

) and tapping END SESSION.

Communicating via BLUETOOTH® after pairing

Make sure the communicator is turned on and within range of the clinician tablet. See the 8880T2 Technical Manual for details. The communicator automatically communicates via the BLUETOOTH wireless technology with the clinician tablet it is paired to. The following icon the communicator is communicating with the clinician tablet via the BLUETOOTH wireless technology.

will appear on the clinician tablet status bar when

Communicator status on clinician tablet

When the communicator is paired to the clinician tablet, swipe down from the top of the tablet to view the following during a programming session:

■ The battery level of the communicator.

■ The connection status of the communicator to the clinician

tablet. Refer to Table 3 on page 15.

Note: An icon that shows the connection status is also displayed in the tablet status bar.

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PROGRAMMER SETUP

HOME SCREEN

The Home screen (Figure 4 on page 18) displays the current pump settings retrieved from the pump at interrogation and the SELECT WORKFLOW panel. Pending settings, or changes made during the session, do not appear on the Home screen until the pump is updated or re-interrogated.

The Home screen shows patient and pump information, current drug information, and reservoir settings. The CURRENTLY DELIVERING section shows which dose was actively being delivered at the time the pump was last interrogated or updated.

■ If a bolus is active, the panel displays the bolus type (prime, single, bridge, roller study, or patient activated) and the time remaining.

■ If an infusion mode is active, the panel displays the current infusion pattern, the dose per day, and a graphic representation of the 24 hour infusion pattern.

The SELECT WORKFLOW panel shows all workows. For more information, refer to “Workows” on page 19.

Pump Time

Pump time is read during interrogation and is used for infusion settings. Changing the tablet time during a programming session will change the pump time.

Warning: The pump is synchronized to the time of the last

programmer used to update the pump. Before updating the pump, consider the following situations that may affect the actual time that the patient receives the intended therapy:

■ Current time on programmer is incorrect.

■ Patient lives in a different time zone than that to

which the programmer is set.

■ Patient is traveling to a different time zone.

■ A change into or out of Daylight Saving Time is going

to occur soon, or has recently occurred.

Prior to making a change in programmer time, verify whether the patient has recently received or will soon receive a programmed bolus or high-rate step. Changing the programmer time forward or backward will affect programmed steps or boluses. Receiving a bolus or step at an unintended time may result in a clinically-signicant or fatal drug overdose or underdose.

Re-Interrogate

Tapping RE-INTERROGATE reads the pump and updates the Home screen to reect the current pump state. For instructions on interrogating the pump, refer to “To interrogate a pump” on page 15.

Note: Only the pump that was interrogated at the start of the programming session can be re-interrogated. To interrogate a different pump, end the programming session and start a session with another pump.

Active Alarms

If an alarm is active when the pump is interrogated, an ACTIVE ALARM button will be shown on the Home screen. Tapping the ACTIVE ALARM button will open the Active Alarm window.

To silence an alarm

1. Tap the ACTIVE ALARM button.

2. Tap the SILENCE PUMP ALARM toggle button to silence

active alarms.

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HOME SCREEN

Displays system status information available at interrogation

Settings button

Figure 4. Home screen example

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Tap to start a workow

HOME SCREEN

3. Update the pump. Refer to “FINISH SCREEN” on page 42.

Note: Alarms will be silenced after the pump is updated.

Workows

A workow is a series of screens that work together to complete a programming task. Workows contain the standard screens needed for a task; a screen that is not part of the current workow can be accessed using the task menu.

Each workow box contains a description of the workow and a START button. If the current programming scenario does not t any displayed workow, select the WORKFLOW GUIDE OFF workow to program the pump without any workow guidance.

During interrogation, the application reads the pump status and automatically selects a recommended workow. Recommended workows will have a “RECOMMENDED” label above the description and START button.

To start a workow

1. Tap the desired workow box.

2. Tap the corresponding START button displayed in the

expanded area.

To add tasks to a workow

1. Tap the task menu ( ) button.

2. Tap the task you want to add.

Note: The added screen appears in the workow navigator. For more information, refer to “Navigation” on page 20.

PROGRAMMING SCREENS

Programming the pump involves reviewing and modifying the settings programmed in the implantable pump. Information and settings may be from an earlier session or may be the default values set during manufacturing. When programming is completed, the pump needs to be updated with the new information.

All programming screens will have the same layout and standard features (Figure 5 on page 21). The following features are available:

■ Action bar – The action bar spans across the top of all

programming screens. For more information, refer to “Action Bar” on page 20.

■ Workow Navigator – The workow tasks spans below the action bar. For more information, refer to “Navigation” on page 20.

■ Alerts – The alerts button is in the bottom left corner of the programming screen. When an alert is active for that screen the button changes color and shows the number of active alerts. For more information, refer to “ALERTS” on page 49.

Screen Features

Note: Throughout this manual, gures showing the programmer

screen are examples. Information displayed on the screen may differ slightly.

Programming screens have common features to provide quick and consistent data entry. The following features are included:

■ Pending changes – A solid green bar at the beginning of the input box or the value displayed in green text indicate that a setting has pending changes—that is, the changes

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PROGRAMMING SCREENS

have not been transferred to the pump. The green bar or green text remains until the pump is updated.

■ Range – For most numeric entries, a valid range appears

below the keypad. If you enter a value above or below the range, an error message will appear.

■ Edit – A purple element indicates the value is able to be

edited. The item header and graphical representation turn purple when the programmer can edit an element.

Navigation

There are multiple ways to navigate through workow tasks. Tasks can be completed in any order, although some tasks depend on previous information to complete.

There are four basic ways to navigate through the workow

screens:

■ The workow navigator contains each task in the workow

with the current task underlined. Tap on the task to go directly to that screen.

■ The PREVIOUS and NEXT buttons move forward or

backward through the workow.

■ Swiping the screen left or right will navigate through the workow.

■ The task menu is accessed by tapping the task menu button. The menu can be used to add screens to a workow or navigate to a workow task. Screens that are not part of the workow are available from this menu. Accessing a task in this way will add it to the workow if it is not already

included.

Action Bar

The action bar appears at the top of all screens for a programming session. Table 4 describes the buttons and indicators that appear on the action bar.

Table 4. Buttons on the action bar

Button Details

Task menu button

■ Tap to access additional screens or navigate along a workow.

■ A workow must be selected for the task menu button to appear.

HOME button

■ Tap to return the app to the Home screen.

■ Navigating to the Home screen does

not end a session or clear any pending information.

Settings button

■ Tap to open a menu that includes additional options.

Settings

The Settings button ( ) opens a menu with additional app options. If selected from the main menu screen, only the Drug Library and About options are available.

■ Add Task – Opens a list of programming screens that are

not included in the current workow. Tap a screen name to add it to the workow.

■ Notes – Opens the NOTES eld. The NOTES eld allows

for entry and review of information (e.g. implant location

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PROGRAMMING SCREENS

Action bar

Task menu

Header

Workow navigator

Previous / Next buttons

Alerts button

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Figure 5. Navigating the app

PROGRAMMING SCREENS

and pump orientation). For more information on Notes, refer to “PATIENT SCREEN” on page 22.

■ Logs – Reads the pump logs and opens the Pump Activity Logs. Pump logs are displayed in reverse chronological

order and are used in troubleshooting issues. For more information, refer to “PUMP ACTIVITY LOGS” on page 53.

■ Reports – Opens the REPORTS screen which provides the ability to view, print, send, and save reports. For more information, refer to “REPORTS” on page 48.

■ End Session – Closes the current programming session and returns to the main menu screen. Any pending changes entered during the programming session will be lost and the pump will not be updated.

■ Drug Library – Opens the drug library screen which stores drug names and associated concentrations. Drug Library entries are available for quick use in the Drugs screen. For more information, refer to “DRUG LIBRARY” on page 47.

■ Calculator – Opens the tablet calculator app. Tap the oating Session in Progress widget to return to the programming session.

■ Help – Opens a Help Overlay on top of the current programming screen.

■ About – Opens a dialogue box which provides the software version, serial number, unique device identier (UDI), CE mark, and other information about the application, clinician tablet, communicator, and implanted device.

PATIENT SCREEN

The Patient screen displays patient information such as name, patient ID, and contact information.

Information from the Patient screen is stored in the pump memory and is accessible any time the pump can be read. Enter or edit patient information if the patient is new or information has changed. Patient name and ID number will be displayed in the action bar during a session and patient information will be used in the Patient Data Service app and appear on reports. For more information, refer to “REPORTS” on page 48.

The NOTES eld is an open input box for additional notes such as implant location and pump orientation. Information in the NOTES eld will be displayed on reports. The NOTES eld can be accessed on the Patient screen, or by selecting Notes from the Settings ( screens. If a note is entered or updated (i.e. has pending changes) an orange exclamation point will appear on the Notes icon.

To enter patient or contact information

1. Tap the input box or drop-down list.

2. Enter or select information.

Note: Enter information in at least two of the following elds: FIRST NAME, LAST NAME, and PATIENT ID to keep patient data unique.

3. Tap the hide keyboard button ( when nished.

) menu. It is also displayed as a button on certain

) to hide the keyboard

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PATIENT SCREEN

PUMP SCREEN

The Pump screen shows detailed information about the pump – the implanted pump name, volume, model number, serial number, calibration constant, estimated replacement date, and the estimated pump time. For information on estimated replacement and device longevity, refer to “DEVICE LONGEVITY” on page 52.

During the rst programming session at implant, make sure the model number and calibration constant retrieved during interrogation match the following:

■ Model number on the package label

■ Calibration constant on the package label

■ Model number etched on the pump

CATHETER SCREEN

The Catheter screen shows information about the implanted catheter. Catheter information must be entered for new implants or when a catheter has changed. The Catheter screen calculates the TOTAL IMPLANTED VOLUME from the entered values. These values are vital for the correct calculation of infusion rate and dosage.

Warning: Use the catheter length recorded at implant or

catheter revision for calculating catheter volume. The actual implanted catheter length and catheter model number are required to accurately calculate catheter volume. A universal value does not exist that can be used as a substitute for this knowledge. An inaccurate calculation of the catheter volume can result in a clinically signicant or fatal drug underdose or overdose.

To enter catheter information

1. Tap the CATHETER MODEL NUMBER drop-down list.

2. Select the catheter model.

Note: If the catheter model is not listed, select the appropriate Other option and enter the model information.

3. Tap the CATHETER IMPLANTED VOLUME input box.

Note: When determining the implanted volume for a twopiece catheter, enter the pump segment rst.

4. Enter the necessary information.

5. Tap the CONFIRM button.

6. If the catheter is a two-piece model, repeat steps 3 through 5 for the tip segment.

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PUMP SCREEN

If only total implanted volume is known

Note: Use this procedure if the total implanted volume is known

but no other information is known.

1. Tap the CATHETER MODEL NUMBER drop-down list.

2. Select Other (volume).

3. Tap the CATHETER IMPLANTED VOLUME input box.

4. Enter a value for total implanted volume.

5. Tap the CONFIRM button.

If catheter model and implanted volume are unknown

If the catheter model and implanted volume are unknown, contact Medtronic for assistance.

DRUGS SCREEN

The Drugs screen is used to maintain the prescribed drug information. Drug volume and concentration for the primary drug are required and need to be entered accurately. The primary drug is used for infusion and bolus calculations and will have a PRIMARY DRUG heading in the drug box.

Any drug can be modied by tapping the drug box and editing any of the settings. Tapping the COMPARE button opens a DRUG SUMMARY screen which shows the name and concentration of the current and pending drugs.

Warning: Rinse the reservoir twice between solutions

when changing drug or decreasing drug concentrations in the pump reservoir (refer to appropriate rell kit manual for specic procedures). A signicant amount of drug may be present in the pump reservoir after emptying the pump. This residual volume cannot be removed by emptying the pump. Rinsing the reservoir between solutions minimizes the amount of drug in this residual volume but does not eliminate it. Failure to account for residual drug in the pump reservoir can result in a concentration that is different than intended and a clinically signicant or fatal drug underdose or overdose. Program a bridge bolus after rinsing the reservoir twice. The bridge bolus advances the remaining old drug (the drug left in the pump tubing, catheter access port, and catheter after emptying and relling the pump) to the catheter tip at the specied ow rate.

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To edit or add a drug entry

1. Tap the edit button ( ) on the drug box or the ADD DRUG button.

2. Modify or enter the drug name.

3. Select a unit from the drop-down list.

DRUGS SCREEN

4. Tap the CONCENTRATION input box.

5. Use the keypad to enter a value for concentration.

6. If you want to make this drug the primary drug, tap the box

next to Primary Drug at the end of the row.

Note: If the Primary Drug box is grayed out, the drug is already marked as the primary drug.

7. Tap the CONFIRM button.

To delete a drug entry

1. Tap the drug box to open the dialogue box.

2. Tap the DELETE DRUG button.

3. Tap DELETE DRUG in the pop-up.

Note: A drug cannot be deleted if it is marked as the

primary drug.

RESERVOIR SCREEN

The Reservoir screen displays the current reservoir volume information. The pump graphic will show the current or pending reservoir volume and the max reservoir volume. The REFILL

PUMP BEFORE date is shown on the Reservoir screen. The REFILL PUMP BEFORE date is an estimate based on the low

reservoir alarm threshold, reservoir volume, and infusion settings (including physician-activated bolus and maximum number of patient-activated doses available to the patient per day)

Notes:

■ The REFILL PUMP BEFORE date may not be displayed on

this screen if infusion settings are not complete.

■ The REFILL PUMP BEFORE date is based on the infusion

dose per day and the maximum number of patient-activated doses available to the patient per day. Extra drug may remain at rell if all doses are not used.

To change the reservoir volume

1. Tap the edit button ( ) on the reservoir volume input box.

Note: Pump graphic and header turn purple.

2. Enter a volume within the specied range or drag the arrows (

3. Tap CONFIRM.

) on the pump graphic to the correct level.

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RESERVOIR SCREEN

INFUSION SCREEN

The Infusion screen is used to program the infusion pattern, which is displayed both graphically and numerically (Figure 6 on page 27). Settings can be modied by adjusting the graphic or by editing the values.

The following terminology is used for elements on the Infusion

screen:

Table 5. Terminology used on the Infusion screen

Base Rate The rate of drug delivered continuously

throughout the day unless interrupted with a step/ bolus. Previously known as basal rate.

24 Hour Dose

Base Dose The dose of drug delivered continuously

Minimum Rate

Pattern Planned time and rate(s) of infusion that is

The Infusion screen is made up of two parts:

■ Dose/Rate panel – Shows the 24 hour dose information

for the displayed pattern and the dose/rate information for the base rate and all steps.

■ Infusion display panel – Shows the infusion settings

in graphic format. Includes the options for changing the infusion mode and additional views of the infusion settings.

The total dose of drug delivered over a 24 hour period.

throughout the day unless interrupted with a step/ bolus.

The lowest infusion setting that will not damage the pump system. It infuses at a rate of approximately 0.006 mL/day.

repeated daily. Multiple patterns are available only in Flex mode.

Selecting an Infusion Mode

Infusion setup is based on an infusion mode. There are three infusion modes available from the infusion setup. Changing modes is available at any time during infusion setup, but changing modes may cause pending infusion settings to be lost.

Three modes are available:

■ Simple Continuous – Delivers a continuous infusion of a specied dose per day. Tapping the COMPARE button opens an INFUSION SUMMARY screen which shows the current and pending infusion settings.

■ Flex – Delivers a sequence of up to 13 independent steps of varying doses, rates, and durations for each 24 hour period. The programmable base rate stops when a step begins and resumes when the step ends.

■ Minimum Rate – Delivers the drug infusion at a rate of approximately 0.006 mL/day.

Note: The infusion modes Temporary Stop and Permanent Shutdown are available only from the Discontinue screen. For more information, refer to “DISCONTINUE SCREEN” on page 41.

When the pump is in Shelf State, the infusion mode is set to Minimum Rate.

To change an infusion mode

1. Tap the edit button ( ) next to the infusion mode title.

2. Tap the SELECT button under the desired infusion mode.

3. Tap CHANGE MODE in the pop-up.

4. Enter the desired 24 Hour Dose using the keypad or by dragging the arrows (

5. Tap DONE.

6. Review the information and tap CONFIRM.

) on the Infusion display panel.

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INFUSION SCREEN

Edit infusion mode

Infusion display panel

Dose/Rate panel

Edit button

Figure 6. Using the Infusion screen

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INFUSION SCREEN

Dose/Rate Panel

The Dose/Rate panel contains the following information:

■ 24 Hour Dose box - Shows the total dosage value for a 24

hour period.

– When the 24 hour dose is unlocked, modifying the

24 hour dose distributes the value proportionally across the base rate and all steps for the 24 hour period.

– When the 24 hour dose is locked, modifying a step

or the total daily dose will adjust the base rate to preserve the locked total daily dose. The base rate is not editable when the 24 hour dose is locked.

■ Lock 24 Hour Dose - The lock icon (

Flex mode.

■ Percent Change - Displayed when the infusion settings

change, the percent change is based on the primary drug. It is not available if the primary drug was changed or drugs were added or deleted.

■ Base input boxes - Show the base rate and base dose

over a 24 hour period.

■ Step input box(es) - Show the rate and dose for each step

over a 24 hour period. As steps are added to the infusion setup, input boxes with the dose/rate will be added to the panel.

) is available only in

Infusion Display Panel

The Infusion display panel elements are shown in Figure 7 on page 29.

In the Infusion display panel, the vertical axis shows the rate in units per hour and the horizontal axis shows a 24 hour cycle. A

step’s top boundary represents the rate, and the side boundaries represent start and end times. Tap outside of the selected element

to deselect.

Below the mode title are tabs for the different views:

■ Daily view – Shows a daily pattern from 12:00 am to 12:00

am the next day. If one pattern is congured, the tab reads Every Day and shows the daily infusion pattern. If two patterns are congured, the two patterns are displayed in the header as the days the patterns are active (eg, Tue-Fri and Sat-Mon).

■ Transition view – Shows a scrolling 24 hour view of the

daily infusion pattern.

■ 7 Day view – Shows patterns over 7 days, from Monday to

Sunday. This view will display all patterns used throughout the week.

■ Edit Patterns – Shows the pattern dial which sets the

concurrent days assigned to the infusion patterns. This is only available in Flex mode. Refer to “Conguring a Weekly Plan” on page 31.

Screen Elements

The Infusion screen uses colors to indicate element state.

■ If elements are not selected or being edited, elements in the Infusion display panel are green colored and elements in the Dose/Rate panel boxes are blue and green.

■ If an element is in edit mode (

If the edit button ( Infusion display panel, arrows ( borders. On the Dose/Rate panel, select an input box to bring up a keypad or scrolling picker.

) is tapped, the element is in edit mode. On the

), the element turns purple.

) appear on the step or base rate

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INFUSION SCREEN

Step

Lock 24 Hour Dose

Step details

Figure 7. Selecting infusion step

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INFUSION SCREEN

Conguring a Pattern

An infusion pattern can be congured by changing the 24 hour dose, the base rate, or any steps. There are two ways to congure an element in edit mode, using the Infusion display panel or numerically using the Dose/Rate panel. The Infusion display panel and numerical entry are linked, so any changes made will be reected in both areas.

To modify the 24 Hour Dose

1. Tap the edit button ( ) on the 24 HOUR DOSE.

2. If editing numerically:

a. Select the PRIMARY DRUG input box and enter the

new value using the keypad.

b. Tap DONE.

3. If editing using the Infusion display panel, tap and drag the arrows (

4. If you want to lock the 24 Hour Dose, tap the lock button (

LOCK.

Note: Locking the 24 Hour Dose is only available in Flex

mode.

5. Review the information and tap CONFIRM.

To modify the base rate

1. Tap the edit button ( ) on the BASE RATE or the base rate in the Infusion display panel.

2. If editing numerically, select the input box for the value to be changed: rate or dose. Enter the value using the keypad.

3. If editing using the Infusion display panel, drag the arrows (

) to the desired value.

4. Tap DONE.

) to the desired value.

) or select the check box next to 24 HOUR DOSE

5. Review the information and tap CONFIRM.

To add a step to a pattern

Note: Steps are only available in Flex mode.

1. Tap ADD STEP button.

2. If editing numerically, select the input box for each value:

start time, duration, dose, or rate. Enter the value using the keypad.

3. If editing using the Infusion display panel:

a. Tap and drag the left arrows (

time.

b. Tap and drag the right arrows (

time or duration.

c. Tap and drag the top arrows (

4. Tap DONE.

5. Review the information and tap CONFIRM.

) to the desired start

) to the desired end

) to the desired rate.

To modify a step

1. Tap the edit button ( ) on the step or the step in the Infusion display panel.

2. If editing numerically, select the input box for the value to be changed: start time, duration, dose, or rate. Enter the value.

3. If editing using the Infusion display panel, tap and drag the left, right, or top arrows for the value to be changed.

4. Tap DONE.

5. Review the information and tap CONFIRM.

To delete a step

Note: The base rate cannot be deleted.

1. Select the step by tapping the input box or the step in the Infusion display panel.

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INFUSION SCREEN

2. Tap the trash can icon at the end of the step header.

3. Tap CONFIRM.

Conguring a Weekly Plan

Flex mode allows for two infusion patterns to be congured, also known as a weekly plan. A weekly plan consists of two infusion patterns referred to as Pattern 1 and Pattern 2. Pattern 2 can be added at any time by tapping Edit Patterns. Pattern 1 and Pattern 2 are both congured in the Infusion display panel.

Note: A maximum of 13 steps total are allowed for both Pattern 1 and Pattern 2. For example, if Pattern 1 has seven steps, Pattern 2 can have a maximum of six.

The 7 Day view allows you to view both infusion patterns at the same time.

To set a weekly plan

1. Tap Edit Patterns.

2. Slide the dial so the patterns start and end on the desired

days. The pattern days are displayed on the left side of the

screen.

Note: The days in a pattern must be consecutive.

3. Tap OK.

BOLUS SCREEN

A bolus is a specic amount of drug (dose or volume) delivered once for a prescribed length of time (duration). The Bolus screen is used to select and calculate the bolus dose and duration. Bolus calculation is achieved by answering a series of setup questions (Standard mode) or using Advanced mode to determine the desired specications.

The Bolus screen has four bolus options:

■ Prime Bolus — Designed to rapidly deliver a specic

volume of uid to ll the components of the system that do not have drug in them. This bolus is commonly used prior to implant to ll the internal pump tubing or after an implant to prime either the catheter or the internal pump tubing and catheter. For more information, refer to “Setting up a Prime Bolus” on page 32.

■ Bridge Bolus — Delivers the drug remaining in the internal

pump tubing and catheter at a rate appropriate for the drug concentration. This bolus is used when a concentration in the pump reservoir is changed and the drug remaining in the internal pump tubing and catheter must be accounted for to prevent a drug underdose or overdose. For more information, refer to “Setting up a Bridge Bolus” on page 35.

■ Single Bolus — Delivers a specied dose over the duration

selected. For more information, refer to “Setting up a Single Bolus” on page 36.

■ Roller Study — Delivers a set volume to verify the pump

roller is functioning properly. For more information, refer to “Setting up a Roller Study” on page 36.

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BOLUS SCREEN

Note: Boluses take precedence over programmed infusion

patterns and patient-activated boluses. The infusion pattern will resume when the bolus is completed.

Recommended bolus

The application will automatically recommend a bolus in some workow situations or in a specic set of circumstances. For example:

■ Prime Bolus is recommended when the pump is in shelf state or as part of a pump implant, pump replacement, or catheter revision.

■ Bridge Bolus is recommended when a drug name, unit, or concentration is changed.

Consult the appropriate drug package for prescribing information. A bolus cannot be programmed if a bolus is already in progress or if Temporary Stop is the current or pending infusion mode.

Setting up a Prime Bolus

A prime bolus is commonly used prior to implant to ll the internal pump tubing and catheter access port or after an implant to prime either the catheter or the internal pump tubing, catheter access port, and catheter. When the bolus nishes, the pump returns to the programmed infusion pattern.

Warning: Mixing of drug and non-drug (sterile water/CSF) uids occurs at the high ow rates used during a priming bolus. This mixing can result in patients receiving drug prior to the end of the priming bolus, as well as a period of reduced drug concentration following the priming bolus, and can lead to adverse events involving drug overdose, underdose, and withdrawal. These adverse events will vary depending on the drug being infused, and could include lack of therapeutic effectiveness, confusion or altered mental state, sleepiness, nausea, respiratory depression, coma or death. Refer to “Emergency Procedures” in the indications, drug stability, and emergency procedures manual and the appropriate drug labeling for specic drug underdose and overdose symptoms and actions. Follow these guidelines regarding priming bolus:

■ Use the priming bolus procedure to ensure that therapy is initiated while the patient is under medical supervision.

■ To reduce the risk of overdose during a priming bolus, consider priming the pump before connecting the catheter to the pump (back table prime) during an initial system implant or a pump replacement.

■ For a full system priming bolus: Avoid high concentration drug solutions with a low total daily dose as the risk for overdose and underdose can be more pronounced.

■ For a full system priming bolus: Priming bolus default parameters have been carefully selected based on extensive modeling and testing. To ensure optimal initiation of therapy, modications to these values are

not recommended.

■ For a full system priming bolus: Based on the

therapeutic index of the drug and the sensitivity of

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BOLUS SCREEN

the patient, some individuals may need additional monitoring until the delivered drug reaches the intended concentration. Do not increase the programmed daily dose within the rst 48 hours following a priming bolus as the delivered drug may not have reached the intended concentration during

this time.

■ Medtronic recommends monitoring patients after

any priming bolus procedure involving intrathecal therapy.

– Opioids: Patients should be monitored with

pulse oximetry for a minimum of 24 hours in a facility equipped with emergency airway management, oxygen, naloxone for treatment of opioid overdose and other emergency services.

– Baclofen: Patients should be monitored in

a facility that provides experienced nursing observation, with the ability and personnel for emergency airway management and ventilator support readily available. Patients should be monitored for a minimum of 8 hours or until they demonstrate stable neurological, respiratory and cardiac function.

– Ziconotide: There are no labeling guidelines for

patient monitoring after starting or restarting ziconotide therapy. Published guidance recommends an overnight admission.

■ Educate caregivers and family members to recognize the signs and symptoms associated with intrathecal drug overdose, underdose, and withdrawal. Instruct them to contact the patient’s physician if they notice any of these signs or

symptoms and to seek emergency assistance as necessary.

The following patient populations were identied as having increased risk of adverse events from drug overdose and

underdose:

■ Elderly patients.

■ Patients with compromised respiratory, renal,

hepatic, or cardiac function.

■ Patients exposed to other agents, such as systemic opioids, alcohol, sedatives, antihistaminics, or psychotropic drugs that can potentiate the central nervous system depressant effects of intrathecal morphine.

■ Opioid-naïve or opioid-sensitive patients undergoing new pump and catheter implants, especially those prescribed high concentration drug solutions with low daily doses.

■ Patients who are sensitive to baclofen and require low daily doses.

■ For baclofen patients undergoing pump or catheter revision, a delay in achieving the intended therapeutic dose could occur and may result in temporary return of symptoms such as increased spasticity or baclofen withdrawal.

Note: Other clinically relevant patient populations may exist in addition to these examples.

When programming a priming bolus, make sure to select the correct drug location. The prime volume will vary depending on the location of the drug within the system and the type of procedure. Refer to the following priming information.

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BOLUS SCREEN

■ Full system implant or pump replacement with aspirated catheter: Prime the internal pump tubing and

catheter.

Note: To reduce the risk of overdose, consider using a priming bolus of 0.300 mL to ll the internal pump tubing and catheter access port with drug before connecting the catheter and implanting the pump (back table prime). Then program a catheter only prime after implant.

■ Pump replacement with non-aspirated catheter: Use a priming bolus of 0.300 mL to ll the internal pump tubing with drug before connecting the catheter and implanting the pump (back table prime). Do not prime the catheter.

■ Catheter replacement or catheter contrast study: Prime the catheter only.

■ Catheter revision:

– Spinal (tip) segment revision: Prime the new

spinal catheter segment.

– Pump segment revision: Prime the new pump

catheter segment and the aspirated spinal segment (unrevised spinal segment must be aspirated).

If a prime bolus is not recommended or further action is needed, a message will appear in the bolus suggestion panel with information why the bolus should not be programmed. For example:

■ Do Not Prime appears if the responses indicate the drug is not in a correct location for performing a prime bolus (eg, only in the catheter or lling the whole system).

■ Action Needed appears if the responses indicate a gap in drug location or the drug is only located in the catheter or catheter access port (CAP). If the question responses are correct, follow the instructions to proceed with the task.

Standard mode is the default mode for conguring a prime bolus, but a bolus can also be congured using Advanced mode. Tapping the toggle button between Standard and Advanced will change conguration modes. Advanced mode allows the user to select a specic prime location (full, cap + catheter, pre-implant, etc) or enter a custom volume and duration. Do not use Advanced mode if you are unsure where the drug is located in the pump tubing and catheter. Contact Medtronic for assistance with using Advanced

mode.

To set up a prime bolus using standard mode

1. Review catheter length/volume.

2. Verify drug location.

Warning: If this is a pump replacement and the catheter

has not been replaced and has not been aspirated, the pump tubing should be primed before connecting the catheter and implanting the pump. Do not program a prime bolus after the catheter has been connected to the pump. Programming a prime bolus in this situation can result in a clinically signicant or fatal overdose.

3. If a prime bolus is the recommended selection, tap the

START CONFIGURATION button to open the dialogue box and proceed to step 4.

4. If no bolus is selected by default, tap the NEW BOLUS button. The SELECT A BOLUS dialogue box opens. Tap the SELECT button under PRIME BOLUS.

5. Answer each scenario question. The answer will appear in

the SCENARIO panel.

6. Tap NEXT after selecting each answer.

7. When all questions are answered, conrm drug locations

using the picture of the pump reservoir and tubing.

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BOLUS SCREEN

Warning: If the catheter is new or has been aspirated

and the pump was primed before implant, prime only the catheter after connecting the catheter and implanting the pump. Do not include the internal pump tubing and catheter access port volume in the prime bolus. Inaccurate drug locations can result in a clinically signicant or fatal overdose.

8. Tap NEXT.

9. The programmer will calculate a bolus volume and duration

based on the scenario answers.

Note: Tap SHOW CALCULATION to show the calculation details.

10. Tap CONFIRM.

Note: Delivery of the prime bolus begins when the pump is

updated in the Finish screen.

Warning: If the pump is being primed before implant, allow

the prime to nish before connecting the catheter to the pump. If the prime is not nished, drug can be bolused into the catheter and can result in a clinically signicant or fatal overdose.

Setting up a Bridge Bolus

A bridge bolus advances the drug remaining in the internal pump tubing, catheter access port, and catheter to the catheter tip at the specied ow rate. Bridge bolus is generally performed after emptying and relling the pump when a drug or drug concentration changes. When the bridge bolus nishes, the pump returns to the programmed infusion pattern.

Warning: Rinse the reservoir twice between solutions

The rate for a bridge bolus is specied according to the 24 hour dose - the bolus duration is calculated based on the amount of time required to replace the internal pump tubing, catheter access port, and catheter contents at the specied rate.

Note: The bridge bolus infusion is delivered in a Simple Continuous pattern regardless of the current infusion pattern. If the current infusion pattern is Flex, consider the effects of averaging the 24 hour dose, especially on patients who receive one or more large bolus doses throughout the day with a relatively low base infusion rate. Compare the hourly rate of the desired 24 HOUR DOSE DURING BRIDGE with the patient’s normal infusion pattern throughout the day to ensure that an appropriate dose is selected.

Standard mode is the default mode for conguring a bridge bolus, but a bridge bolus can also be congured using Advanced mode. Tapping the toggle button between Standard and Advanced will change conguration modes. Advanced mode requires that the previous drug information be entered and allows the user to select

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BOLUS SCREEN

a specic volume (full system, catheter, etc) or enter a custom volume and dose. Do not use Advanced mode if you are unsure where the drug is located in the pump tubing and catheter. Contact Medtronic for assistance with using Advanced mode.

To set up a bridge bolus using standard mode

1. If a bridge bolus is the recommended selection, tap the

START CONFIGURATION button to open the dialogue box and proceed to step 4.

2. If no bolus is selected by default, tap the NEW BOLUS button. The SELECT A BOLUS dialogue box opens. Tap the SELECT button under BRIDGE BOLUS.

3. Use the arrow (

DURING BRIDGE value.

Note: Custom Value must be within the specied range.

4. Tap NEXT.

5. The programmer will show the bridge bolus information and drug scenario for review.

Note: Bolus volume and duration are system generated values based on the drug concentration, selected 24 HOUR DOSE DURING BRIDGE, and the physical volume of the internal tubing, catheter access port, and catheter. Calculated values may change when different values are

entered.

6. Review bolus settings.

7. Tap CONFIRM.

Notes:

■ Delivery of the bridge bolus begins when the pump is updated in the Finish screen.

■ Patient-activated dosing is disabled for the duration of the bridge bolus.

) button to select the 24 HOUR DOSE

Setting up a Single Bolus

A single bolus is a one-time therapeutic dose of drug. In the bolus setup, dose and duration values are entered and the system will calculate the rate. The SINGLE BOLUS DOSE panel shows the dose for primary and additional drugs. When the single bolus is nished, the pump returns to the programmed infusion pattern.

To set up a single bolus

1. Tap the NEW BOLUS button. The SELECT A BOLUS

dialogue box opens.

2. Tap the SELECT button under SINGLE BOLUS.

3. Enter the dose.

4. Enter the duration.

Note: The rate will be calculated based on the dose and duration inputs.

5. Tap the CONFIRM button.

Notes:

■ Delivery of the single bolus begins when the pump is updated in the Finish screen.

■ The RATE is displayed as the dose per hour, even when the duration is less than an hour. For example, if the dose is 8 mcL and the duration is 30 min, the rate is 16 mcL/hr.

Setting up a Roller Study

A roller study is a short prime bolus to examine the functionality of the pump and is not designed to deliver therapeutic dose. The duration, volume, and dose are all generated by the pump system. When the roller study is nished, the pump returns to the programmed infusion pattern.

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BOLUS SCREEN

Note: The pump has the ability to detect a motor stall. If you

suspect an undetected motor stall occurred, contact Medtronic for assistance on performing a roller study.

To set up a roller study

Warning: To prevent overdose or underdose, do not perform

a roller study without understanding the implication on therapy. If unsure, contact Medtronic for assistance.

If a bolus of approximately 0.010 mL could cause an overdose, aspirate approximately 1-2 mL of uid from the catheter access port to ensure removal of drug from the catheter access port and catheter.

1. Tap the NEW BOLUS button. The SELECT A BOLUS

dialogue box opens.

2. Tap the SELECT button under ROLLER STUDY.

Notes:

■ Pending conguration is displayed with system generated values.

■ Delivery of the roller study begins when the pump is updated in the Finish screen.

Canceling or Continuing a Bolus in Progress

If a bolus is detected at pump interrogation, the Bolus screen shows the type of bolus in progress, time remaining on bolus, and CANCEL BOLUS button. The dose, rate, duration, and scheduled end time for the active bolus are shown in a panel on the right side

of the screen.

When Temporary Stop or Minimum Rate is selected on the Discontinue screen, any active bolus will be automatically stopped when the pump is updated.

■ When Minimum Rate is selected, the bolus is canceled by default. Bolus delivery can be continued by tapping the UNDO BOLUS CANCELLATION button.

■ When Temporary Stop is selected, the bolus is canceled by default. Bolus delivery cannot be continued and the UNDO

BOLUS CANCELLATION button is disabled.

To cancel a bolus in progress

Warning: If a bolus is canceled the drug remaining in the

pump and catheter may need to be accounted for to prevent a clinically signicant or fatal drug underdose or overdose.

1. Tap the CANCEL BOLUS button.

2. Update the pump. Refer to “FINISH SCREEN” on

page 42.

To continue a canceled bolus

If the pump has been updated with a canceled bolus, the bolus cannot be continued. Continuing a bolus is only available when a bolus has been canceled and the change has not been communicated to the pump.

1. If the Bolus screen shows a canceled bolus, tap the UNDO BOLUS CANCELLATION button.

2. Update the pump. Refer to “FINISH SCREEN” on page 42.

Note: When the pump is updated, the bolus is not canceled.

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BOLUS SCREEN

MYPTM™ SCREEN

The Medtronic Personal Therapy Manager (PTM) is an accessory to the Medtronic SynchroMed II Infusion System. The Personal Therapy Manager can be used only with the SynchroMed II Infusion System and allows the patient to activate delivery of physician-programmed supplemental doses of medication.

The myPTM™ screen requires the use of the PTM accessory. For PTM setup instructions and applicable warnings, cautions, indications, and contraindications, refer to the accompanying PTM manual. Do not enable the Personal Therapy Manager if you do not have the PTM accessory. Contact the appropriate Medtronic representative for additional information.

Programming the Pump for Patient-Activated Dosing

Before the PTM can be used, the pump must be programmed to enable the PTM. This initial programming is performed using the clinician programmer.

Notes:

■ To enable patient-activated dosing, the pump must be programmed to Simple Continuous mode.

■ The dose/day entered on the Infusion screen is the base rate of the infusion prescription except when a physicianactivated or patient-activated bolus is active.

■ Physician-activated boluses (priming, single, and bridge boluses) take precedence over patient-activated dosing requests and programmed infusion modes. Patients are unable to activate a dose during physician-activated boluses.

■ A record of patient-activated dosing requests is displayed

under Logs on the clinician programmer, in addition to the

Personal Therapy Manager reports.

■ If appropriate, program other pump parameters before programming the pump for patient-activated dosing.

The following terminology is used for programming the patientactivated dose:

Table 6. Terminology used on the myPTM screen

Lockout Duration

Dose Restriction or Dose Restriction Interval (DRI)

Minimum time between patient activated doses. The Lockout Duration can range from 10 minutes to 23 hours and 30 minutes. The lockout duration cannot be shorter than the patient-activated dose duration.

Maximum number of patient-activated doses in a specied period of time. DRI is a rolling window of time that never resets. When a bolus is requested, the PTM will conrm that the maximum number of boluses for the specied interval has not been exceeded before it delivers the new bolus.

For example, if the Dose Restriction is 4/24 hrs, and it’s currently 3 pm, the PTM will count the number of boluses that have been delivered since 3 pm of the previous day (24 hours prior). If the patient has received 4 boluses during that time, the new bolus will not be delivered. If, however, the patient has received 3 or fewer boluses in the past 24 hours, the new bolus will be delivered.

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MYPTM™ SCREEN

Max Activations within 24 Hours

Increase in dose percentage

Maximum number of bolus doses in a day (midnight to midnight).

Calculated maximum increase in daily dose over the Simple Continuous 24 hour dose if all the patient activated doses were to be used on a given day.

To program the pump for patient-activated dosing

1. Using the clinician programmer, verify that Simple Continuous mode is selected and a base rate or 24 Hour Dose is entered on the Infusion screen.

2. On the myPTM screen, tap the ENABLE MYPTM button.

3. Enter the patient-activated dose.

Notes:

■ Patient activated dosing is based on the primary drug.

■ Tapping the COMPARE button opens a myPTM SUMMARY screen which shows the current and

pending myPTM settings.

■ To view calculations for a secondary drug, tap the MAX 24 HOUR DOSE input box. Secondary drug information is available after patient-activated dosing setup is complete and is displayed for reference only.

4. Tap CONFIRM.

5. Review the dose and default duration values in the

DOSE AND DURATION element. Make any necessary adjustments by tapping the appropriate input boxes and entering new values.

Notes:

■ Some dose and duration combinations may not be possible because of the pump system design.

■ The default setting is the time required to deliver the dose at the maximum infusion rate.

6. Tap CONFIRM in the DOSE AND DURATION element to

move on to setting patient restrictions.

7. Set the LOCKOUT DURATION.

8. Select the DOSE RESTRICTION.

9. Select the MAX ACTIVATIONS WITHIN 24 HOURS.

10. Tap CONFIRM.

11. Review the calculated dosages displayed:

■ The maximum 24 hour dose (if all patient boluses

are delivered)

■ Increase in dose percentage (if all patient boluses are delivered)

12. When you are nished setting pump parameters, update the pump. Refer to “FINISH SCREEN” on page 42.

Note: Any update to the pump will start the Lockout Interval. Patient-activated dose requests during this period will be denied.

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MYPTM™ SCREEN

ALARMS SCREEN

The Alarms screen summarizes alarm information and allows the user to view and edit alarm settings. Pump alarm tones sound from the pump. There are three different types of alarms:

■ Low Reservoir Alarm – An alarm that sounds when

the calculated reservoir volume falls below the specied threshold. The app recommends a default volume of 2.0 mL. This input box sets the threshold for a low reservoir alarm.

■ Critical Alarm – A critical alarm is a two-tone alarm with

available values in 10 minute intervals from 10 minutes (the default) to 2 hours. Critical alarms signal a pump condition with imminent termination of therapy. This input box sets the interval for critical alarms.

■ Non-critical Alarm – The non-critical alarm is a single-tone

alarm with available values in 1-hour intervals from 1 hour (the default) to 6 hours. Non-critical alarms signal a pump condition that requires a clinician’s attention but does not mean termination of therapy. This input box sets the interval for non-critical alarms.

The Alarms screen also shows the rell pump before date, max volume, and current volume in the graphic. The REFILL PUMP BEFORE date is an estimate based on the low reservoir alarm threshold, reservoir volume, and infusion settings (including physician-activated bolus and maximum number of patientactivated doses available to the patient per day). The CURRENT VOLUME is set on the Reservoir screen and displayed on the Alarms screen to aid setting the low reservoir alarm.

The EXAMPLES for each alarm is a list of events that cause critical and non-critical alarms. These are only examples and not necessarily conditions that are present in the pump.

To set the Low Reservoir Alarm volume

1. Tap the edit button ( ) on LOW RESERVOIR ALARM input box.

2. The low reservoir alarm displays a default value of 2.0 mL. Enter a value within the specied range using the keypad or the arrows (

Warning: To maintain ow rate accuracy, program the

pump to alarm before the volume of drug remaining in the pump reservoir decreases below 1.0 mL. At volumes less than 1.0 mL, ow rate decreases rapidly and stops as the volume reaches 0 mL. This can result in underinfusion and a return of underlying symptoms, drug withdrawal symptoms, or a clinically signicant or fatal drug

underdose.

3. Tap CONFIRM.

) on the pump graphic.

To set alarm interval

1. Tap the edit button ( ) on the input box.

2. Tap the arrow (

3. Tap CONFIRM.

) button and select the desired interval.

To demonstrate pump alarm tones

1. Tap the edit button ( ) on the input box.

2. Place the communicator over the pump.

3. Tap the PLAY SOUND button (

4. Tap CONFIRM.

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ALARMS SCREEN

DISCONTINUE SCREEN

The Discontinue screen is used to stop a pump from providing therapy, either temporarily or permanently. The screen provides a summary of the infusion settings after a discontinue method is selected. There are four discontinue methods available:

■ None — This option does not stop the pump. It can be used

to continue therapy if the Discontinue screen is mistakenly added to the workow. This is the default selection.

■ Minimum Rate — This option delivers the drug infusion at

a rate of approximately 0.006 mL/day. The infusion rate is designed to provide a nontherapeutic dose without stopping the pump and is an alternative to stopping the pump.

■ Temporary Stop — This option stops the pump mechanism

completely but alarms remain enabled. Therapy can only be restarted by selecting a new infusion pattern and updating the pump. This method should only be enabled for 48 hours maximum to avoid damage to the internal pump tubing. A critical pump alarm will sound after 48 hours.

■ Permanent Shutdown — This option permanently stops

the pump and associated therapy, and disables alarms. The pump cannot be restarted. A password is required for this option if the pump is not at End of Service. Contact Medtronic to obtain the password.

Caution: If therapy is discontinued for an extended period,

ll the pump reservoir with preservative-free saline. For programmable pumps, program the pump to minimum rate mode (0.006 mL/day). Rell the pump as needed to ensure the pump always contains uid in the reservoir and uid pathway. Stopping the pump for extended periods or allowing the pump reservoir to empty completely can damage the system and require surgical replacement.

To set Minimum Rate

1. Select MINIMUM RATE. The 24 Hour Dose shows the

0.006 mL/day rate.

2. In the Finish screen, update the pump. Refer to “FINISH SCREEN” on page 42.

To stop the pump temporarily

1. Select TEMPORARY STOP. 24 HOUR DOSE shows a

0.00 programmed rate.

2. In the Finish screen, update the pump. Refer to “FINISH SCREEN” on page 42.

3. After the pump update, a device alert appears. Tap OK.

Caution: To prevent damage to the pump, do not stop drug

delivery for more than 48 hours.

To restart the pump after Temporary Stop

1. On the Infusion screen, tap CONTINUE THERAPY.

2. In the Finish screen, update the pump. Refer to “FINISH

SCREEN” on page 42.

Permanently Shutting Down a Pump

Stopping the pump permanently requires a password. Before performing this procedure, contact Medtronic to obtain the password.

After the update has completed, interrogate the pump to verify settings.

To perform a permanent pump shutdown

1. Select PERMANENT SHUTDOWN.

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DISCONTINUE SCREEN

2. Enter the password.

3. Tap CONFIRM.

4. In the Finish screen, update the pump. Refer to “FINISH SCREEN” on page 42.

5. Tap the OK button to acknowledge the alert.

Note: After permanent shutdown, the pump workow returns to the Home screen. All alarms are disabled, the navigation bar is disabled, and no other workow tasks can be performed.

Shutting Down an Unusable Pump

A pump becomes unusable when it reaches End of Service (EOS) or rarely for other reasons. For device longevity information, refer to “DEVICE LONGEVITY” on page 52.

When pump interrogation detects an unusable pump, an alert is displayed. The unusable pump alert includes a SHUT DOWN PUMP button to shutdown the pump immediately and a HOME button to open the Home screen.

Note: The SHUT DOWN PUMP button silences all pump alarms.

To shutdown the pump

1. Tap the SHUT DOWN PUMP button.

2. Make sure the communicator is over the pump.

Note: After permanent shutdown, the pump workow returns to the Home screen. No other workow tasks can be performed.

FINISH SCREEN

The Finish screen provides an overview of the changes made on each screen for review before communicating updates to the pump (Figure 8 on page 46). Relevant notications or alerts are shown with their corresponding workow tasks. At the bottom of the screen, the UPDATE button updates the pump with the pending settings.

Reviewing Changes

Review pending changes carefully before updating the pump.

■ Settings with pending changes have a PENDING

notication in green.

■ Screens with an active alert have a box with the number and types of active alerts.

To review pending changes

1. Review the pending settings in each row by scrolling down on the Finish screen. Table 7 lists important items to check before updating the pump.

2. If an alert is active, review each alert to make sure the update can proceed. If necessary, return to the corresponding screens and make changes.

3. If no alerts are active, proceed to “Updating the Pump” on page 43.

Table 7. Reviewing pending settings

Finish Screen Row

Patient Make sure changed information appears as

What to Check

expected.

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FINISH SCREEN

Finish

What to Check

Screen Row

Catheter Make sure the catheter volume is acceptable.

Reservoir Make sure the Reservoir volume setting

matches the actual volume of drug in the reservoir.

Drugs Make sure each listed drug has an appropriate

concentration.

Infusion Make sure the infusion pattern is acceptable.

Make sure the 24-Hour Dose for all drugs are acceptable.

Make sure the percentage change in 24-hour dose is acceptable.

Make sure the change from current 24-Hour Dose to pending 24-Hour Dose is acceptable.

Bolus Make sure any alerts are addressed.

If a bolus is pending, make sure the dose, duration, and rate are acceptable.

Alarms Conrm that the Low Reservoir Alarm volume

is acceptable.

Combined Therapy

Check for replacement estimate (ERI/EOS) alerts.

Make sure the Rell pump before date is acceptable.

Make sure the Bolus 24-Hour dose is acceptable.

Make sure the Infusion 24-Hour dose is acceptable.

Make sure the Total 24-Hour dose is acceptable.

Updating the Pump

The UPDATE button is found at the bottom of the Finish screen and initiates telemetry to program the pending settings to the pump. Pending settings will not be programmed to the pump if the update does not complete. If the update is started but not completed, the pump may be in an unknown state and the user will be notied with a high-level alert. Refer to “If telemetry is interrupted during a pump update” on page 45 for more details.

The UPDATE button is disabled in the presence of certain alerts that must be resolved before the update can proceed. In this case, the UPDATE button is colored red and shows the number of issues that must be resolved. Other alerts will allow you to update the pump, although you may be prompted to acknowledge these alerts before the update proceeds.

The UPDATE button is not enabled unless settings have been changed since the last update and critical pump settings have been completed in earlier workow screens. The following critical pump settings must have valid values before updating the pump:

■ Primary drug (name, concentration value, and concentration units)

■ Reservoir volume

■ Total catheter volume

■ Infusion pattern

■ 24-hour dose

■ Low reservoir alarm volume

■ Critical and non-critical alarm intervals

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FINISH SCREEN

Warning: Following a pump replacement or catheter

revision, consider dosing requirements carefully. If therapy has been interrupted for a prolonged period of time, the patient may become drug naive. Overdose may occur if the drug is introduced at the previous dosage.

Warning: Do not send a patient home if:

■ There is a pump memory error.

■ There is an unresolved alarm condition.

■ Telemetry was interrupted during pump update or

interrogation.

■ Pump status was not conrmed.

Failure to correct pump memory errors, alarm conditions, or incomplete telemetry can result in incorrect or incomplete programming, unknown or unexpected pump status, and a clinically signicant or fatal drug underdose or overdose.

Warning: Before interrogating or updating the pump, conrm

that the time and date on the programmer are correct. Incorrect time and date can result in incorrect programming and estimated dates.

Caution: No more than one hour should elapse between

determining pump status and transmitting a new infusion prescription to the pump. If more than one hour has elapsed, repeat pump interrogation to determine pump status (because the volume of drug in the pump reservoir may have changed, causing a change in pump status). Note that interrogating the pump will automatically start a new session and unsaved data will be lost.

Warning: The pump is synchronized to the time of the last

programmer used to update the pump. Before updating the pump, consider the following situations that may affect the actual time that the patient receives the intended therapy:

■ Current time on programmer is incorrect.

■ Patient lives in a different time zone than that to

which the programmer is set.

■ Patient is traveling to a different time zone.

■ A change into or out of Daylight Saving Time is going

to occur soon, or has recently occurred.

To update the pump

Warning: To use the nonsterile programmer system

Note: If updating the pump with a new prescription is delayed, drug that has moved into the internal pump tubing or catheter during the delay needs to be accounted for.

1. Tap the UPDATE button. The CONFIRM CHANGES

dialogue box opens.

2. If the changes are not correct, tap the CANCEL button to

return to the Finish screen.

3. If the changes are correct, tap the acknowledgment check box.

4. Place the communicator over and as close as practical to the implantable pump and tap the CONFIRM button.

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FINISH SCREEN

Telemetry begins and a telemetry progress window opens. Do not remove the communicator until the update is complete.

Note: The target symbol on the back of the communicator indicates the location of the internal antenna. The target should be facing and centered over the implantable device.

Warning: To ensure successful telemetry, hold the

5. After telemetry is complete, remove the communicator from the pump.

6. Tap OK in the dialogue box.

7. Verify pump settings have been updated.

If telemetry is interrupted during a pump update

When telemetry is interrupted, either by user action or system action, the pump state is unknown, and the pump may or may not be stopped. The system responds to interrupted telemetry with a high-level alert.

To continue updating the pump, tap the CONTINUE UPDATE button. If the application is closed and the pump is left in an unknown state, start a programming session with the pump and check all of the current pump settings.

ENDING A SESSION

After the pump update is complete, the application will return to the Home screen and display the new pump information. The current session will remain open on the application until the

session is ended.

To end a session

1. Tap the Settings ( ) button in the action bar.

2. Select End Session.

3. Tap the END SESSION button on the pop-up message.

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ENDING A SESSION

Marks pending changes

Navigates to screen

Scroll bar shows pending changes and active alerts

Figure 8. Finish screen with changes pending

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ENDING A SESSION

DEMO MODE

Demo mode allows access to all programming features without interrogating or updating a device. When the programmer is in Demo mode it is not communicating with a real device and does not require the use of a communicator.

Demo mode can be used to work with the programmer for training and demonstrative purposes and to familiarize yourself with the programmer interface before a programming session.

If Demo mode is selected, the programmer remains in Demo

mode until the session is ended.

DRUG LIBRARY

The Drug Library stores drug names and associated concentrations that have been programmed to the pump. Drug Library entries are available for quick use when adding or editing drugs. New drug library entries become available after the pump is updated. Entering a drug name lters the drug library to show similar results.

The Drug Library is available by tapping the Settings ( in the action bar and selecting Drug Library. Tapping the CLOSE button exits the Drug Library.

) button

To start Demo mode

1. From the main menu screen, select DEMO.

2. Check that DEMO appears in orange on the action bar of

the app.

To exit Demo Mode

1. Tap the Settings ( ) button.

2. Select End Session.

Note: The app will return to the main menu screen.

To add a drug entry

1. Use the keyboard to enter the drug name.

Note: Verify spelling as drug library entries are re-used.

2. Tap the Units drop-down list to select a unit.

3. Tap the Concentration input box and use the keyboard to

enter the drug concentration.

4. Tap the ADD DRUG button at the end of the row.

To delete a drug

1. Tap the ‘X’ at the end of the drug row.

Note: A drug cannot be retrieved after being deleted from

the Drug Library. If a deleted drug is needed again, it must be entered again or restored to the programmer by completing a programming session with a pump that has the desired drug.

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DEMO MODE

REPORTS

The Reports screen provides the ability to view, print, and save session reports. Reports is available from the main menu screen or at any time by tapping the Settings ( Reports. Printed or saved reports provide a permanent record of what was changed or modied during a programming session. Tapping CLOSE returns the user to the current programming

screen.

These reports are available:

■ Patient Report contains information relevant to the patient.

■ Session Short Report contains information about the

settings that were programmed into the pump at the last update.

■ Session Long Report is similar to the Session Short Report, but also contains additional information about each

update that occurred during a session, clinician notes, and device session history. If logs were accessed during the session, log events are available on the report.

■ Rell Report provides a list of all patients who have a patient record on the programmer that is associated with an implantable pump. This report can be ltered by a range of dates for the next rell date. The Rell Report is also available through the Patient Data Service app. For more information, refer to “PATIENT DATA SERVICE APP” on page 50.

Reports can be ltered by tapping the FILTERS button. During a programming session, reports can be ltered by rell or session date. When a session is not in progress, reports can be ltered by patient name, patient ID, session date, and rell date.

Selecting a report shows the following actions:

) button and selecting

Table 8. Report actions

Icon Details

View Report

■ Tap to view a PDF of the report.

Share Report

■ Tap to send a report to another app or destination.

Download Report

■ Tap to save a PDF of the report to a pre- set location on the tablet.

Delete Report

■ Tap to delete the report from the tablet.

When an action is selected, a pop-up to remove patient identifying information appears. Checking the box will black out all patient identifying information on that version of the report and the report will no longer include the patient’s name in the title.

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REPORTS

ALERTS

Alerts are messages that provide instructions or indicate conditions that require action. Alerts are activated in response to a variety of conditions, and are therefore presented differently depending on the circumstances. Some alerts are informational and may not require any action. For other alerts of a more critical nature, you may be prompted to acknowledge or resolve them.

There are three types of alerts (Table 9).

Table 9. Alerts

Alert Type Description

Low level (blue)

Medium level (orange)

High level

(red)

INFORMATION Indicates information about

functionality or status.

CAUTION Indicates a caution and

that the message must be acknowledged or resolved.

WARNING Indicates a warning about

the presence of a potentially hazardous condition that must be acknowledged or an issue that needs to be resolved before the pump can be updated.

or your acknowledgment before an update can proceed. For information on updating the pump, see “FINISH SCREEN” on page 42.

To view and acknowledge alerts

1. Tap the ALERTS button.

2. A separate pop-up box appears for each alert. The type of

alert (eg, INFORMATION) is shown in the heading of the pop-up box. Swipe left or right to view individual alerts.

3. Tap ‘X’ (or anywhere outside of the alert pop-up box) to

close the alert pop-up box.

Note: The ALERTS button shows a count of active alerts related to the current screen. When all alerts are resolved or cleared, the ALERTS button will read “NO ALERTS.”

As you navigate through a workow, alerts may activate by expanding over the bottom of the screen and the PREVIOUS/ NEXT buttons. The following actions are available:

■ Tap the < arrow to minimize the alert

■ Tap the alert to view the entire text

The Finish screen displays alerts that you should be aware of before updating the pump. Some alerts may require resolution

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ALERTS

PATIENT DATA SERVICE APP

The Patient Data Service app can be used to access reports (generated from patient data records) for all patients whose Medtronic devices have been programmed using the clinician programmer apps on the clinician tablet. The Patient Data Service app icon (Figure 9) is located on the clinician tablet’s home

screen.

Patient Data Service

Figure 9. Patient Data Service app icon

The search function of the Patient Data Service app can lter reports by categories such as patient, date, or device. Selecting a patient report in the search results opens the REPORTS screen with additional options (such as generating and displaying a PDF le of the report). Refer to “REPORTS” on page 48.

TROUBLESHOOTING

For assistance or for questions, contact:

■ US only: Medtronic Technical Services at 1-800-707-0933.

■ Outside US: Your regional representative listed in this

manual.

This section covers noninvasive troubleshooting and error messages relating to the Model A810 Clinician Programmer.

Approach troubleshooting conservatively. Prior to performing invasive procedures, ensure that all noninvasive procedures have been considered and contact the appropriate Medtronic representative listed at the end of this manual.

Pump Troubleshooting

Interrogate the pump for current settings before beginning troubleshooting. If pump alarms are active, interrogate the pump to determine the cause of the active alarm. For instructions on interrogation, refer to “To interrogate a pump” on page 15.

PDF Auto-Delete Feature

The PDF auto-delete feature automatically deletes PDF reports from the tablet’s local storage after a designated amount of time.

The auto-delete setting affects all PDF reports for all patients who have had their device programmed by the clinician tablet.

Note: The PDF auto-delete feature does not delete patient data records from the Patient Data Service app.

The auto-delete feature is automatically enabled with a default number of days. Tap the Settings ( of the Patient Data Service app to change the PDF auto-delete settings if desired.

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) button on the initial screen

Communicator Troubleshooting

The programmer automatically attempts to connect to the most recently used communicator. If the previous connection was through BLUETOOTH wireless technology, the programmer and communicator attempt to reestablish connection using BLUETOOTH. If the original connection was through a USB connector cable and the cable is unplugged, the programmer tries to connect through BLUETOOTH wireless technology.

Use the following list of problems and possible solutions to resolve other problems with communication.

PATIENT DATA SERVICE APP

Cannot pair the communicator with the tablet

When attempting to connect through BLUETOOTH:

■ Make sure the communicator is turned on and within range of the clinician tablet. See the 8880T2 Technical Manual for details.

■ Make sure BLUETOOTH is enabled on the clinician tablet.

The communicator cannot communicate wirelessly with the clinician tablet during a programming session

Possible reasons:

■ You are in an environment where multiple devices are using BLUETOOTH wireless technology and thereby creating interference.

■ You have moved into an environment where the BLUETOOTH wireless technology is prohibited.

Possible solutions:

■ Use the USB connector cable to connect the communicator to the clinician tablet.

■ Make sure the BLUETOOTH wireless technology is enabled on the clinician tablet.

The communicator cannot communicate with the implantable device

Metal surfaces can interfere with the communication between the communicator and the implantable device.

■ If the communicator is on a metal table or a metal tray, move the communicator to a nonmetal surface.

■ There could be radio-frequency (RF) interference.

■ Move the communicator closer to the implanted

device.

■ The communicator must remain within 9 centimeters (approximately 3.5 inches) of the implanted device.

The communicator is damaged

Use a different communicator:

■ Ensure the damaged communicator is turned off before using another communicator.

■ If using a replacement communicator prior to starting a programming session, use the USB connector cable and pair the replacement communicator to the clinician tablet.

Refer to “To pair the communicator with a clinician tablet” on page 15.

Or if replacing the communicator while in a programming session, use the USB connector cable to connect the communicator to the clinician tablet and continue with the programming session.

Communicator battery level is low

■ Open the battery case and replace the batteries. If needed, instructions for replacing the communicator batteries are in the Model 8880T2 Communicator Technical Manual.

■ After replacing the communicator batteries, the clinician programmer app will connect with the communicator using the BLUETOOTH wireless technology and resume the session.

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TROUBLESHOOTING

The clinician tablet, the clinician programmer app, or the communicator is unresponsive

Turn off the power for the clinician tablet or the communicator, then turn the power on.

DEVICE LONGEVITY

Device longevity is the calculated number of service months remaining based on actual usage rates. All SynchroMed II pumps will need to be replaced after 7 years of service. When a pump reaches end of service, it is designed to automatically shut off with adequate warning.

Refer to the device implant manual for more information about device longevity.

Two pump alarms are associated with the end of service:

■ Elective Replacement Indicator (ERI) is a non-critical

alarm that is activated when the pump nears the end of its service life (EOS). ERI indicates the pump will continue to operate within specications for 90 days (for ow rates up to 1.5 mL per day). The pump reaches end of service and stops 90 days after ERI. Refer to the pump implant manual for more information about the 90 day period between ERI and EOS.

■ End of Service (EOS) is a critical alarm that is activated

if the pump is not replaced within 90 days of ERI. The EOS activation indicates the pump has reached the end of its service life. At EOS, the pump stops, but telemetry is available until the pump battery is depleted.

ERI and EOS are displayed on several programmer screens:

■ Before ERI, the Home, Pump, and Finish screens display

an Estimated Replacement eld, showing the estimated month and year that ERI will occur. After ERI, these screens display an EOS eld, showing the month and year that EOS will occur.

Note: The estimated replacement date is based on current programmed delivery and may be less than expected in pumps with high ow rates. If the ow rate is reduced, a

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DEVICE LONGEVITY

new date is calculated which may be signicantly different from the current value.

■ The Session Short Report and Session Long Report include an Estimated Replacement (estimated month and year that ERI will occur) or EOS entry which is identical to the entry in the workow screens.

■ The ERI and EOS alarms are recorded in the Pump Activity Log.

Since the pump stops automatically at EOS, it is important to replace the pump in the 90-day period between ERI and EOS.

PUMP ACTIVITY LOGS

Pump Activity Logs are pump conditions that are recorded and displayed in reverse chronological order. Be sure to reinterrogate the pump and retrieve the Pump Activity Logs as part of troubleshooting.

Table 10 lists potential pump activity log event text along with actions, if required.

There are three different ways to view events:

■ Patient Events - Shows up to 80 of the most recent events

logged when any patient function is requested.

■ System Events - Shows up to 30 of the most recent events

logged by the system.

■ All Events - Shows both Patient and System events.

Each entry includes the following elements:

■ Event time - Date and time the event occurred.

■ Event - An event description or number (events with only

an event number are for diagnostic purposes).

■ Event Type - Identies whether the event is a patient or

system event.

Note: The date and time of pump activity log events is relative to the current time on the programmer. If the pump time and programmer time are different, consider the difference when determining when an event actually occurred.

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To view the Pump Activity Logs

1. Re-interrogate the pump.

2. Tap the Settings (

3. Select Logs.

PUMP ACTIVITY LOGS

) button in the action bar.

Table 10. Event log messages and actions

Code Message Action

00 Critical Alarm - End of Service

(EOS) Occurred

01 Critical Alarm - Pump Reset Contact Medtronic

03 Critical Alarm - Pump Motor

Stall Occurred

04 Critical Alarm - Stopped Pump

Duration Exceeded 48 Hours

05 Critical Alarm - Critical Pump

Memory Error

06 Critical Alarm - Empty Reservoir

Alarm

07 Critical Alarm - Pump Defaulted

to Minimum Rate

08 Critical Alarm - Infusion

Handshake Error

12 Non-Critical Alarm - Infusion

History Cleared

13 Silent Alarm - Pump Safety

Count in Effect

14 Programming step (3-5) None required

15 Pump Permanently Shut Down None required

16 Programming step (7-7) None required

18 Event Status cleared None required

19 User Silenced an Active Audible

Alarm

Replace the pump

If stall recovery has not occurred, contact Medtronic

If desired, restart pump and verify ow rate

Contact Medtronic

Rell pump and update rell-related parameters

Contact Medtronic

None required

Contact Medtronic

None required

Code Message Action

21 Programming step (2–2) None required

22 Programming step (1-1) None required

23 Programming step (5-0) None required

24 Programming step (4-9) None required

26 Programming step (6-6) None required

28 System Event Log Cleared None required

29 Patient Activation Event

Counters Cleared

30 Stack Overow Error Contact Medtronic

1A Pump Motor Stall Recovery None required

2A Programming step (8-0) None required

2B Critical Alarm - Pump Reset

Due to Low Battery

2C Critical Alarm - Pump Reset

Due to Firmware Error

2D Critical Alarm - Pump Reset

Due to Telemetry Command

2E Time Check Error None required

2F Stack Pointer Error Contact Medtronic

0A Non-Critical Alarm - Low

Reservoir Alarm

0B Non-Critical Alarm - Next Rell

Date Alarm

0C Non-Critical Alarm - Adjusted

Rell Date Alarm

None required

Contact Medtronic

Rell pump and update rell-related parameters

2020-07-01 English

PUMP ACTIVITY LOGS

Code Message Action

0D Non-Critical Alarm - Elective

Replacement Indicator (ERI)

0E Non-Critical Alarm - Non-

Critical Memory Error

0F Non-Critical Alarm - Hybrid Trim

Parameters Error

88 myPTM

89 Rejected myPTM

Bolus Request None required

Bolus

Request

Replace pump within 90 days of ERI

Contact Medtronic. Verify that all programmed data are correct and pump status appears normal

Contact Medtronic

None required

2020-07-01 English

PUMP ACTIVITY LOGS

2020-07-01 English

Manufacturer

Medtronic, Inc.

710 Medtronic Parkway Minneapolis, MN 55432 USA www.medtronic.com Tel. +1-763-505-5000

Authorized Representative in the European Community

Medtronic B.V. Earl Bakkenstraat 10 6422 PJ Heerlen The Netherlands Tel. +31-45-566-8000

Europe/Africa/Middle East Headquarters

Medtronic International Trading Sàrl Route du Molliau 31 Case Postale 84 CH - 1131 Tolochenaz Switzerland www.medtronic.eu Tel. +41-21-802-7000

Asia-Pacic

Medtronic International Ltd. 50 Pasir Panjang Road #04-51 Mapletree Business City Singapore 117384 Singapore Tel. +65-6870-5510

*M968017A021*

M968017A021 Rev A 2020-07-01

Medtronic A810 Programming Guide

Specifications and Main Features

Frequently Asked Questions

User Manual

TABLE OF CONTENTS

DEVICE DESCRIPTION

Model A902 Patient Data Service App

Abbreviations and Terminology

Model 8880T2 Communicator

Model A901 Communication Manager App

DATA SECURITY AND NETWORK CONNECTIVITY

Data Security

Network connectivity

Installing application updates

Returning the clinician tablet

PROGRAMMER SETUP

The Clinician Programmer App

Main Menu Screen

When the app is in the background

Preparing the Tablet for Programming

Communicator Preparation

USB connector cable - when to use

Installing updates to the communicator

Communicator icons in tablet status bar

Pairing the Communicator with a Clinician Tablet and Interrogating the Pump

Communicating via BLUETOOTH® after pairing

Communicator status on clinician tablet

HOME SCREEN

Pump Time

Re-Interrogate

Active Alarms

PROGRAMMING SCREENS

Screen Features

Navigation

Action Bar

Settings

PATIENT SCREEN

PUMP SCREEN

CATHETER SCREEN

DRUGS SCREEN

RESERVOIR SCREEN

INFUSION SCREEN

Selecting an Infusion Mode

Dose/Rate Panel

Infusion Display Panel

Screen Elements

BOLUS SCREEN

Recommended bolus

Setting up a Prime Bolus

Setting up a Bridge Bolus

Setting up a Single Bolus

Setting up a Roller Study

Canceling or Continuing a Bolus in Progress

MYPTM™ SCREEN

Programming the Pump for Patient-Activated Dosing

ALARMS SCREEN

DISCONTINUE SCREEN

Permanently Shutting Down a Pump

Shutting Down an Unusable Pump

FINISH SCREEN

Reviewing Changes

Updating the Pump

If telemetry is interrupted during a pump update

ENDING A SESSION

DEMO MODE

DRUG LIBRARY

REPORTS

ALERTS

PATIENT DATA SERVICE APP

TROUBLESHOOTING

Pump Troubleshooting

PDF Auto-Delete Feature

Communicator Troubleshooting

DEVICE LONGEVITY

PUMP ACTIVITY LOGS