Medtronic A810 Programming Guide
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
Application version 1.1
™
II infusion systems
QUICK APPLICATION OVERVIEW
HOME and Settings buttons
Task menu - Tap to access
additional screens or
navigate
Selected workow
Workow 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
Workow - After reviewing current pump settings, the user must choose a workow. Workows contain a series of screens used to
complete programming tasks. See “Workows” on page 19.
Navigation - Users can navigate through the app by swiping left or right, tapping the task in the workow 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 workow and contains a side-by-side comparison of all program settings.
The user must review all settings to conrm 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 specications, and
instructions for use.
Refer to the literature provided by the clinician tablet manufacturer for information regarding wireless
use.
TABLE OF CONTENTS
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
Workows ..................................................................... 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
7
Infusion Display Panel .................................................. 28
Screen Elements .......................................................... 28
Conguring a Pattern .................................................... 30
Conguring 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 identication (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 specications.
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 Denition
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 workow.
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 notications.
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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
congurations could also introduce additional risks. Analyze,
evaluate, and control any identied 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 notied 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.
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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.
■ Conrm 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 notication 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, conrm
that the time and date on the programmer are correct.
Incorrect time and date can result in incorrect programming
and estimated dates.
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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
conrmation 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 workows. For more
information, refer to “Workows” 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-signicant or
fatal drug overdose or underdose.
Re-Interrogate
Tapping RE-INTERROGATE reads the pump and updates the
Home screen to reect 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 workow
HOME SCREEN
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