Medtronic A51300 Programming Guide

CLINICIAN APP

FOR SACRAL
NEUROMODULATION
THERAPY

Clinician Programming Guide for
InterStim™ systems

with Model 97800 InterStim X
neurostimulator

A51300

Application version 1.0

SYMBOLS

Explanation of symbols in this manual

Refer to the appropriate product for symbols that apply.

Manufacturer

Authorized representative in the European
community

For USA audiences only

Magnetic Resonance (MR) Conditional

Importer

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

Android

TM

is a trademark of Google LLC.

The handset, as congured, does not support voice
communication and therefore cannot be used to make
any calls (including emergency calls).

Information available for the system:

The information for prescribers manual provides information
about contraindications, warnings, precautions, adverse events,
sterilization, patient selection, individualization of treatment, and
component disposal.

For customers in Japan, the appropriate package insert
provides information about indications, safety, contraindications,
warnings, precautions, and adverse events.

The indications sheet provides information about indications
and related information. For customers in Japan, the
appropriate package insert provides information about
indications.

The system eligibility, battery longevity, specications manual

provides information about neurostimulator selection, battery
longevity calculations, and battery characteristics.

The system overview and compatibility insert provides
information about component compatibility.

MRI guidelines provide information about any MRI conditions

and MRI-specic contraindications, warnings, and precautions

for MRI scans with the neurostimulation system.

Product manuals, such as programming guides, recharging
guides, and implant manuals provide device descriptions,

package contents, device specications, product-specic

warnings and precautions, and instructions for use.

The clinical summary provides information about the

clinical study results for the neurostimulation system.

Refer to the literature provided by the clinician handset
manufacturer for information regarding wireless use.

Refer to the Communicator technical manual for warnings,
precautions, device description, package contents, device

specications, instructions for use, and maintenance

information.

TABLE OF CONTENTS

GENERAL WARNINGS AND CAUTIONS ....9

OVERVIEW ................................................ 10

Intended Use ........................................................10

About This Guide ................................................10

QUICK TIPS ............................................... 11

Using the Workow Navigator ........................... 11

Indicators and Icons ........................................... 11

GETTING STARTED .................................. 13

Accessing the Clinician App .............................. 13

Creating a Password ...........................................13

Menu Screen ........................................................ 14

Demo Mode .......................................................... 14

Using the Communicator to Pair the Handset and

Neurostimulator ..................................................15

Setting Implant Date............................................16

WORKFLOWS ............................................ 18

Starting a Workow .............................................18

Conguring the Implanted Neurostimulator

(Congure Implant Workow) ............................ 18

Setting up implant conguration .....................................19

Entering patient information ............................................19

Checking device and system status ................................19

Therapy Parameter Settings ..............................21

Maximum settings .............................................................28

Optimizing device settings ...............................................28

6

A51300 English 2021-11-01

Selecting Cycling feature and time ..................................29

Performing an Integrity Measurement (Check

Impedance Workow) .........................................30

Electrode polarity ..............................................................31

Checking Neurostimulator MRI Eligibility (View

MRI Status Workow) .........................................32

MRI - PREPARING FOR AN MRI SCAN .... 33

WORKING WITH PROGRAMS .................. 37

Standard Programs ............................................. 37

Custom Programs ...............................................37

Enabling programs for patient use ..................................40

Reviewing a Therapy Programming Session ... 40

Ending a programming session .......................................41

Using the Stop Therapy feature .......................................41

DIAGNOSTICS ........................................... 42

Usage Graph ........................................................ 42

To view the usage graph: .................................................44

Event Log ............................................................. 44

Usage report ........................................................46

REPORTS .................................................. 47

Accessing a Downloaded Report ...................... 47

ADDITIONAL FEATURES .......................... 49

About Screen ....................................................... 49

Managing Devices .............................................. 49

Software Information ..........................................50

Data security ......................................................................50

Network connectivity ........................................................50

2021-11-01 English A51300

7

Installing application updates ..........................................51

Installing communicator updates ....................................51

Returning the handset ......................................................51

Model A901 Communication Manager Application ........52

Model A902 Patient Data Service Application ................52

TROUBLESHOOTING ............................... 53

8

A51300 English 2021-11-01

GENERAL WARNINGS AND CAUTIONS

GENERAL WARNINGS AND CAUTIONS

WARNINGS:

Wound contact — Do not use the communicator on an

unhealed wound. The communicator is not sterile, and
contact with the wound may cause an infection. Keep a
sterile bandage or barrier between the wound and device.

Sterile eld — When using the communicator in a

sterile eld, place the communicator in a sterile bag. The

communicator is not sterile and cannot be sterilized.

CAUTIONS:

Telemetry signal disruption from EMI — Do not attempt

telemetry near equipment that may generate electromagnetic
interference (EMI). EMI may cause a disruption in clinician
programmer function.

Unresponsive app or handset — Use the recommended
troubleshooting steps if the clinician app or handset becomes
unresponsive. An unresponsive app or handset may result
in an inability to complete the implant procedure or other
programming sessions.

Note: Other Warnings and Cautions are found throughout
this manual.

2021-11-01 English A51300

9

OVERVIEW

OVERVIEW

The Medtronic Model A51300 clinician application (app)
is intended for use with the HH90 Handset and TM90
Communicator to program, adjust, and troubleshoot the
Medtronic Model 97800 InterStim X neurostimulator.

Intended Use

The clinician app is intended to program neurostimulators for
sacral neuromodulation therapy.

About This Guide

This programming guide contains information a clinician
needs to set up, use, and troubleshoot the clinician app on
the handset. This guide provides instructions on how to use
the clinician app to program an implanted neurostimulator.

■ Before using the clinician app for the rst time, refer
to the information provided with the handset for initial
handset setup.

■ All patient-related instructions on using the patient app
on the handset are included in the A52300 Patient
Therapy App Patient User Guide for InterStim systems
with Model 97800 InterStim X neurostimulator.

■ Patient-related instructions on using the communicator
are included in the TM90 Communicator Instructions for
Use provided with the device.

10

A51300 English 2021-11-01

QUICK TIPS

QUICK TIPS

See the following information for helpful tips to aid you in
using the clinician app, and to help you better understand the
contents of this programming guide.

Using the Workow Navigator

The workow navigator is displayed at the top of every
screen when you are in a workow and represents the

screens/ tasks that can be completed on each screen. A title

that is highlighted and underlined in the workow navigator
indicates your position in that workow. For more information
on workows, see “WORKFLOWS” on page 18.

You can use the workow navigator in the following ways:

■ Swipe to the left or right to view previous or subsequent
screens within a workow.

■ Tap on a title to jump to a different screen.

A title that is highlighted and underlined indicates your position within a

workow.

Figure 1. Workow navigator

Indicators and Icons

The following is a list of the icons found in the clinician app
along with their associated descriptions.

Notes:

■ The following is not an all-inclusive list of all the icons
found in the clinician app, but rather a list of the more

2021-11-01 English A51300

11

QUICK TIPS

important icons or those that appear most frequently
within the app.

■ If an icon or button appears gray within the clinician app,
that option is not available.

Icon Icon description

Tap for additional screen options.

Indicates that the neurostimulator device
has been previously paired.

Tap to access the About screen, Manage
Devices screen, or end a programming
session. This icon appears only when in a

workow or on the Home screen.

Indicates that the clinician app is operating
in Demo mode.

Displays the current electrode congurations

settings for a program.

Tap to check battery level.

Tap to check impedance.

12

Tap to exit the current screen and go back to
the one you were previously on.

Indicates the program is enabled for patient
use, and is visible to the patient.

Indicates the program is not enabled for
patient use, and is not visible to the patient.

Tap to end the current programming session
and exit the app.

A51300 English 2021-11-01

GETTING STARTED

GETTING STARTED

Before using the clinician app to program the neurostimulator,
see the following sections for basic information about:

■ Accessing the clinician app

■ Creating a password

■ Using the menu screen

■ Operating in Demo mode

■ Pairing to the implanted neurostimulator

Accessing the Clinician App

You can access the clinician app by locating the InterStim X
Clinician icon on the main screen of the handset (Figure 2).
Tap the icon to open and begin using the clinician app.

InterStim X

Clinician

Figure 2. A51300 Clinician app icon for the Model 97800

InterStim X neurostimulator

Note: The rst time you open the app, it will request

permission for data storage and session overlay. Tap OK to
continue. Then tap ALLOW on the next message.

Creating a Password

The clinician app requires a password to use the app. A
password is required to be entered under the following
conditions:

■ Upon launch of the app

■ After 30 minutes of inactivity

Note: When you launch the clinician app for the rst time,

you will be asked to enter the default password. Contact

2021-11-01 English A51300

13

GETTING STARTED

Medtronic support for the default password. You will need to
obtain the default password before creating your own unique
password.

To create a password:

1. Enter the Medtronic default password in the appropriate

eld. Contact Medtronic support to obtain the default

password if you haven’t already.

2. Tap OK to continue to the next screen.

3. Enter your unique password in the appropriate eld.

Note: The password is case-sensitive and must contain
at least six characters.

4. Conrm your new password by entering it a second

time in the appropriate eld and tap CREATE when
nished.

Note: For information on resetting a forgotten
password, see “TROUBLESHOOTING” on page 53.

5. Select your region using the options provided on the
handset.

6. Tap NEXT to continue on to the Menu screen.

14

Menu Screen

Upon entering your password, you are taken to the Menu
screen. On the Menu screen, you can access Demo mode,
connect the communicator and neurostimulator to the
handset, or access patient reports.

Demo Mode

Demo mode allows you to simulate using the clinician app
without being paired to an actual neurostimulator device.
DEMO is displayed next to the screen title when the clinician
app is operating in Demo mode.

A51300 English 2021-11-01

GETTING STARTED

Using the Communicator to Pair the Handset and Neurostimulator

All programming functionality takes place within the Connect
option on the Menu screen. Tapping this option allows you
to begin the process of using the communicator to pair the
implanted neurostimulator to the clinician app on the handset.

To pair the handset and implanted neurostimulator using
the communicator:

1. Press

on.

2. Navigate to the Menu screen, and tap CONNECT.

3. Place the communicator near the handset.

4. The communicator will attempt to connect to the

handset. The blue LED indicator on the communicator
will continuously blink to indicate it is on and in
discovery mode.

5. If you have previously paired the communicator to the

handset, the communicator will automatically attempt
to connect to the handset. If the blue LED indicator on
the communicator is solid and no longer blinking, the
communicator is now connected to the handset, skip to
step 8.

Note: If you are having trouble connecting
the communicator to the handset, see

“TROUBLESHOOTING” starting on page 53.

6. If the communicator has not been previously paired to

the handset, tap SWITCH COMMUNICATOR on the
handset.

7. Select the appropriate communicator device according

to the serial number shown on the Connection screen,
and tap CONTINUE. The blue LED indicator on the
communicator will be solid and no longer blinking. This

signies the communicator is now connected to the

handset.

on the communicator to turn the communicator

2021-11-01 English A51300

15

GETTING STARTED

Note: The serial number, e.g. NPA-xxxxxxx, is located
on the back of the communicator, and should match
what is listed on the Connection screen.



CAUTION: Ensure you are connecting to the proper

communicator by conrming the serial number on

the device. Failure to do so could extend the implant
procedure or programming session.

8. Ensuring the communicator is on, place the
communicator over the implanted neurostimulator site
and tap FIND DEVICE on the handset.

9. Select the appropriate neurostimulator device
according to the serial number and tap CONTINUE. If
the neurostimulator serial number is not listed on the
Connection screen, tap RETRY.

Notes:

■

displayed next to the serial number of the
neurostimulator device indicates which device has
been most recently paired to the handset.

■ Connecting to a new INS may take some time. If the

INS has not nished connecting after a few minutes,

press Cancel and try again.

■ If you are having problems pairing to the

neurostimulator, refer to “TROUBLESHOOTING” on

page 53.

16

Setting Implant Date

Set implant date in the eld shown on the screen in Figure 3.

To view implant date, navigate to the About screen.

A51300 English 2021-11-01

GETTING STARTED

Figure 3. Set Implant Date screen (serial number shown is for

example only).

2021-11-01 English A51300

17

WORKFLOWS

WORKFLOWS

Workows are used to assist you in navigating programming
sessions. Workows for programming an implanted

neurostimulator include:

■ Congure implant

■ Check impedance

■ View MRI status

Starting a Workow

Starting a workow allows you to complete tasks for a
programming session. You can access workows on the

Home screen.

To start a workow:

1. Tap the name of a workow to see an expanded view
and description.

2. Tap START to proceed with the desired workow.

Conguring the Implanted Neurostimulator
(Congure Implant Workow)

The Congure Implant workow allows you to congure

the neurostimulator for a patient. The main features of the

Congure Implant workow include:

■ Manage implant conguration

■ Manage patient information

■ Congure therapy parameters

■ Check therapy and/or electrode impedance

■ Check battery status

■ Enable programs for patient use

■ Create custom programs

■ View a diagnostic report

■ View the summary screen

18

A51300 English 2021-11-01

WORKFLOWS

Setting up implant conguration

The Congure Implant screen allows you to enter information

required for determining the patient’s MRI eligibility, such as
lead model, device implant location, lead tip location, and
the presence of abandoned product from removed systems.
Even partial systems can have MRI interactions such as RF
heating.

WARNING: Ensure the implant conguration is up-to-date

and accurate. If component information is entered incorrectly,
the patient could be unnecessarily restricted from having an
MRI scan or could be allowed to have an inappropriate MRI
scan, which could cause serious or permanent patient injury.

Entering patient information

The Patient screen allows you to enter optional patient
information (name, patient ID, gender, and date of birth).

Checking device and system status

The Status screen provides information about the
neurostimulator and allows you to check the battery level
of the neurostimulator and system impedance. Notice the
battery and impedance rows; tap the battery and impedance
icons for details. Table 1 displays the device status icons
for impedance check and their associated description and
meaning.

Table 1. Neurostimulator impedance check icons and
descriptions

Icon Description Meaning

Orange circle with
exclamation point

Green circle with
check mark

Status is suspect.
Requires further
investigation.

Status is good. No
further investigation
needed.



2021-11-01 English A51300

19