Medtronic A820 Programming Guide

A820
myPTM™ App and Personal Therapy Manager
for SynchroMed™ II
Patient User Guide
App version 1.0
Medtronic, SynchroMed, the Medtronic logo, and myPTM are trademarks of Medtronic.
®
Wi-Fi
and Wi-Fi Alliance® are registered
trademarks of Wi-Fi Alliance.
SYMBOLS
Explanation of symbols
Manufacturer
Conformité Européenne (European Conformity). This symbol means that the device fully complies with European Directive AIMD 90/385/EEC.
Authorized representative in the European community
For USA audiences only
Note: The handset does not support voice communication and therefore cannot be used to make any calls (including emergency calls).

Quick Start Overview

Quick Start Overview
HandsetCommunicator Pump
Figure 1. Position of communicator next to
pump
myPTM™
Figure 2. myPTM app icon
The myPTM app, installed on the handset, allows you to request boluses of drug from your pump.
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Quick Start Overview
Quick Start Overview
To request a bolus, follow the steps in the order listed:
1. Turn on the handset and communicator. Check that they are charged.
2. Place the communicator directly over your pump.
3. Keep the communicator over the pump. Tap the myPTM app icon on the handset.
myPTM™
4. When the myPTM app is open, tap the Deliver Bolus button.
5a. The check mark conrms
that your bolus is now being delivered. Remove communicator from pump.
OR
OR
5b. The exclamation mark means that the bolus was rejected. Read the on-screen message for more information. Remove communicator from pump.
For detailed PTM directions, refer to “Using the PTM” on page 22.
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Quick Start Overview
Refer to the communicator instructions for warnings, precautions, and charging information.
Refer to the handset materials for charging and setup information.
Refer to the infusion system patient manual for
warnings, precautions, risks, and benets of the
infusion system.
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TABLE OF CONTENTS
Quick Start Overview ....................................... 4
How to Use This Guide .................................. 10
Abbreviations and Buttons............................. 11
Table 1: Abbreviations found in guide .............. 11
Table 2: Buttons found in the myPTM app ........ 11
Glossary ........................................................ 13
Safety Information ......................................... 16
Warnings ......................................................... 16
Precautions ..................................................... 16
Adverse events ............................................... 17
PART ONE: How to Use the Personal
Therapy Manager (PTM) ..............................
19
About the PTM............................................... 20
Purpose of the PTM (indications for use) .... 20
Description of the myPTM app ...................... 20
How does the myPTM app work ................... 20
Using the PTM ............................................... 22
Requesting a drug bolus ............................... 22
Storing and charging the PTM ..................... 24
PART TWO: myPTM App Features ............. 25
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myPTM App Features .................................... 26
Tutorials .................................................. 26
Therapy details ........................................... 26
About ............................................................. 27
Resync ........................................................ 28
Features for clinician use .............................. 28
PART THREE: Alarms and Troubleshooting .
29
Pump Alarms and Alerts ............................... 30
Checking pump alarms and alerts ................ 30
myPTM app alert messages .......................... 30
Table 3: Types of myPTM app alerts .................. 31
Troubleshooting ............................................. 32
Table 4: Scenarios and solutions for pump
problems .............................................................. 32
Table 5: Scenarios and solutions for PTM
problems .............................................................. 33
PART FOUR: Replacing the PTM and Getting
Help ...............................................................
Replacing the PTM and Disposal .................. 38
Replacing the PTM ......................................... 38
PTM disposal .................................................. 38
Pairing Replacement Parts with the Pump .... 39
Pairing the replacement handset and
communicator with the pump .......................
Pairing the replacement handset only.......... 40
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37
39
Quick Start Overview
Pairing the replacement communicator only 40
Getting Help with the PTM............................. 42
When to call your clinician ............................ 42
How to contact Medtronic .............................. 42
PART FIVE: Software Information .............. 43
Software Information ..................................... 44
Data security ................................................... 44
Supporting apps ............................................. 44
Index .............................................................. 45
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How to Use This Guide

How to Use This Guide
This guide contains information for patients about the PTM:
■ A glossary describing terms that may be unfamiliar to you begins on page 13.
■ Instructions describing how to use your PTM to receive a drug bolus begin on page 22.
■ Solutions for problems you may experience are found in “Troubleshooting”, beginning on page 32.
■ Contact information is found in “How to contact Medtronic” on page 42.
Always discuss any questions or concerns you have about your health with your clinician. Your clinician has your medical records and knows your medical history. As a medical device manufacturer, Medtronic is not able to comment on your medical condition.
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Abbreviations and Buttons

Abbreviations and Buttons

Table 1: Abbreviations found in guide

Abbreviation Explanation
app software application
EMI electromagnetic interference
PTM Personal Therapy Manager,
includes handset, app, and communicator

Table 2: Buttons found in the myPTM app

Icon Details and Actions
About button: Tap to view information
about the PTM and pump. Alert button: Tap to view alert
messages. Deliver Bolus button: Tap to receive a
bolus. Information button: Tap to view more
information.
Menu button: Tap to open the menu.
Pairing button: Tap to remove pairing
between the app and the pump. Reports button: Tap to open the
reports screen.
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Abbreviations and Buttons
Table 2: Buttons found in the myPTM app
Icon Details and Actions
Resync/ Retry button: Tap to reset
communication between app and pump.
SWITCH COMMUNICATOR button: Tap to pair a different communicator.
Therapy Details button: Tap to view information about your prescription.
Tutorials button: Tap to view tutorial video.
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Glossary

Glossary
Action bar
On-screen toolbar found at the top of the app screen.
Application (app)
A program designed for a specic use.
Bolus
Additional dose of medication released from your pump.
Button
A symbol or graphic on the app screen that represents a command.
Caution
A statement that describes an action or situation which could harm you or damage the device.
Clinician
A healthcare professional such as a doctor or nurse.
Communicator
A device that helps the handset communicate with the implanted medical device.
Dose
The amount of drug or uid given.
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Glossary
Electromagnetic interference (EMI)
A eld of energy made by equipment found in
the home, work, medical, or public environments. EMI may be strong enough to interfere with the operation of your Personal Therapy Manager.
Handset
A hand-held electronic device that allows you to manage your therapy. The app is installed and runs on the handset.
Infusion system
An implanted system that delivers drugs or uids to a specic site in your body.
Lockout
The length of time that you must wait between bolus doses.
myPTM app
The software application that allows you to request boluses from the pump.
Personal Therapy Manager (PTM)
Hand-held devices that allow you to supplement the continuous infusion of medication with patient­activated boluses. The Personal Therapy Manager includes the handset, app, and communicator.
Precaution
See Caution.
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Glossary
Programming
When drug, therapy, or Personal Therapy Manager settings are sent to your pump.
Pump
The round, metal device that stores and delivers your medication.
Therapy
Treatment of a disease or condition. When infusion therapy is prescribed, an implanted
infusion system is used to deliver drugs or uids to a specic site in your body.
Warning
A statement that describes an action or situation which could seriously harm you.
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Safety Information

Safety Information

Warnings

Personal Therapy Manager use — Do not use more than one Personal Therapy Manager (of any model) with your pump. A drug overdose may occur if a request for a bolus is made using more than one Personal Therapy Manager, resulting in serious patient injury or death.
Personal Therapy Manager may affect other implanted devices — Do not place the communicator over another medical device (for
example, pacemaker, debrillator, neurostimulator,
another pump). The Personal Therapy Manager could change the operation of the other device.

Precautions

Communication interference from EMI —
Electromagnetic interference (EMI) is a eld of
energy made by equipment found in the home, work, medical, or public environments. EMI may be strong enough to interfere with the connection between the handset and implanted device. If EMI is disrupting the connection, move away from or turn off the likely source of EMI.
Always follow instructions — Ensure that the handset and communicator are working and are charged. If the PTM is not communicating with the pump, or if you notice a pump alarm or an alert message, promptly call your clinician or Medtronic. Failure to follow the instructions can lead to not enough drug delivered from the pump and the return of symptoms.
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Safety Information
Refer to “Getting Help with the PTM” on
page 42. Refer to “Replacing the PTM” on
page 38 for replacement information. Contact
information is found in “How to contact Medtronic”
on page 42.

Adverse events

In clinical studies of devices similar to the
Personal Therapy Manager, the following
reported adverse events were considered related
to intrathecal morphine: nausea (vomiting),
constipation, urinary retention, daytime
drowsiness, itching, rash, excessive sleepiness,
sleep difculty, confusion, euphoria, withdrawal,
excessive sweating, swelling caused by uid
retention, ushing of face or anxiety, diarrhea,
dizziness, dry mouth, allergic reaction, dysphoria
(profound state of dissatisfaction), hallucinations,
leg weakness, fall, headache, u-like symptoms,
numbness after activating a dose, shortness of
breath, taste distortion, and weight gain.
Symptoms of overdose may include shallow or
slow breathing, excessive sleepiness, swelling
due to uid retention, low blood pressure, and
reduced heart rate.
Symptoms of withdrawal may include
restlessness, body aches, chills, sweating, and
pupil dilation.
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PART ONE: How to Use the
Personal Therapy Manager (PTM)

About the PTM

About the PTM

Purpose of the PTM (indications for use)

The Personal Therapy Manager (PTM) is an accessory to the SynchroMed II Infusion System. It allows you to request additional doses of medication from your pump as prescribed by your clinician. This additional medication is called a bolus.
For more details about how your SynchroMed II Infusion System works, see the infusion system patient manual.

Description of the myPTM app

The PTM consists of the Model HH90 handset installed with the Model A820 myPTM app, and the Model TM90 communicator. The components of the PTM must be used together to connect to your pump.
The Model A820 myPTM app is intended to allow requests of additional doses of drug from your SynchroMed II pump. The myPTM app will run on the supplied handset and cannot be installed on a personal phone. Contact your clinician for a demonstration of how to use the PTM.

How does the myPTM app work

Your infusion system continuously delivers medication from your pump, through your catheter to your infusion site. Your PTM communicates wirelessly with your pump and allows you to
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About the PTM
request additional doses of medication based on your clinician’s prescription.
The pump will be programmed to communicate with the myPTM app. The PTM will be paired with your pump before you can use it.
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Using the PTM

Using the PTM

Requesting a drug bolus

Follow the steps in the order listed below each time you request a bolus. You will need both the handset, installed with the myPTM app, and communicator.
1. Make sure that the handset and communicator are turned on and charged.
2. Place either at side of the communicator directly over the pump (Figure 1 on page
4).
3. From the handset’s main screen, tap the icon to open the myPTM app:
myPTM™
4. On the HOME screen (Figure 3), press Deliver Bolus
.
5. Hold the communicator over the pump until you see the check mark
, which indicates
that your bolus was successfully started.
6. Remove the communicator from the pump.
The countdown timer indicates the time until the next bolus is available.
For more information about the status of your bolus request, tap the information button the word Lockout.
Refer to “Troubleshooting” on page 32 if you have problems requesting a bolus.
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next to
Tap to open
menu
Using the PTM
Tap to
view alert
messages
Tap to view
Therapy Details
Figure 3: HOME screen with Deliver Bolus
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Using the PTM

Storing and charging the PTM

Store the handset and communicator after use. Make sure that the handset and communicator are charged. The myPTM app will show an alert message when the handset or communicator battery is low.
For charging information, refer to the communicator and handset materials.
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PART TWO: myPTM App Features

myPTM App Features

myPTM App Features
Additional information is available by selecting the menu button corner of the screen (Figure 4).
Tap to open
Tutorials
The myPTM app includes a brief tutorial that will help you understand its basic functions. When you
open the myPTM app for the rst time, the tutorial
will start. On the last tutorial screen, select the check box to not show the tutorial each time the app is started.
in the action bar in the upper left
Tap to
view alert
menu
Figure 4: Action bar
messages
If you would like to view the tutorial again, you can do so at any time. From the list of menu options, select Tutorials.
Therapy details
From the menu, select Therapy Details for more information about your bolus and drug prescription.
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myPTM App Features
Bolus Details
The BOLUS DETAILS screen displays information about your drug bolus, as prescribed by your clinician:
Bolus Duration: The amount of time it takes for one bolus to be delivered.
Dose Restriction (Interval): The number of
boluses allowed in a specic time period.
Max Activations: The maximum number of boluses allowed from midnight to midnight.
Lockout Duration: The length of time between boluses.
Note: Bolus delivery also will be locked out immediately after a pump programming
session or rell.
Expected Rell Date: This is an estimated date of when the low reservoir alarm will sound. The date may change, depending on how frequently boluses are delivered.
Visit your clinician for a drug rell before the expected rell date.
Tap Infusion Daily Dose to see details about your prescription, which lists the prescribed drug and the amount of drug delivered daily.
Tap Bolus Dose to see the amount of drug delivered by your pump each time you request a bolus.
About
Select About to view details about PTM components, such as serial and model numbers.
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myPTM App Features
Resync
Tap Resync any time you need to reconnect the myPTM app with the pump.

Features for clinician use

Reports
Your clinician will use the Reports feature to create reports.
Pairing
Your clinician will use this feature to disconnect the PTM from your pump.
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PART THREE: Alarms and
Troubleshooting

Pump Alarms and Alerts

Pump Alarms and Alerts

Checking pump alarms and alerts

If you hear a pump alarm, you can check the status of the pump by following these directions.
1. Open the myPTM app
2. If an alert message does not appear, reconnect the myPTM app with your pump. Select the menu button the menu.
3. Read the message that appears and follow the on-screen instructions.
Refer to “myPTM app alert messages” on page 30 for more information.

myPTM app alert messages

You can view alert messages previously retrieved from the pump by tapping on the alert button
in the upper right corner of the myPTM app screen (Figure 3). Read the alert message and follow the instructions. The color of the number next to the alert button ( title indicate the alert type, as shown in Table 3. Contact your clinician if you have any questions about alerts.
.
. Tap Resync in
) and the alert message
To view the most recent alert messages, reconnect the myPTM app with your pump. Select the menu button
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. Tap Resync in the menu.
Pump Alarms and Alerts

Table 3: Types of myPTM app alerts

Alert type Suggested action
Information
(blue)
Caution
(orange)
Warning
(red)
No action is needed.
Follow the instructions in the alert to resolve the issue. Call your clinician as soon as possible if you cannot resolve the issue on your own.
Follow the instructions in the alert message immediately. Contact your clinician.
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Troubleshooting

Troubleshooting
This chapter will help you nd solutions for
problems with your PTM. If you cannot solve a problem, or if the problem is not listed here, contact your clinician.

Table 4: Scenarios and solutions for pump problems

Scenario Solutions
The pump alarm is sounding.
Signicant
change in symptoms.
A message says that patient bolus is disabled.
Refer to “Checking pump alarms and alerts” on page 30 for instructions about how to check pump alarm messages.
Contact your clinician. Read the alert message and number to your clinician.
Note: If you need to view the alert message again, tap on the alert button (
) in the
action bar.
Your pump should be checked by your clinician.
Refer to “When to call your clinician” on page 42 for more information.
The pump is not programmed for use with the PTM. Contact your clinician to enable the PTM.
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Troubleshooting
Table 4: Scenarios and solutions for pump problems
Scenario Solutions
Message: “Incompatible Pump Found”
Check to make sure the handset (with the myPTM app) and communicator are the ones paired to your pump.
The pump found is not
If the problem persists, contact your clinician.
paired with the handset. Please move the communicator over the paired pump.

Table 5: Scenarios and solutions for PTM problems

Scenarios Solutions
Message: “No Pump Found”
The PTM does not connect to the pump when requesting a bolus.
The communicator did not successfully communicate with the pump.
1. The communicator must be 2.5 cm (1 inch) or less from the pump. Place the communicator as close as possible to the pump.
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Troubleshooting
Table 5: Scenarios and solutions for PTM problems
Scenarios Solutions
Note: The communicator will not connect to the pump while it is charging.
2. Move away from equipment that may generate electromagnetic interference (EMI) or turn off the source of EMI. EMI may disrupt communication, preventing the dose from starting. Refer to the infusion system patient manual for more information about EMI.
3. If the problem persists, contact Medtronic. Contact information is found in “How to contact Medtronic” on page 42.
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Troubleshooting
Table 5: Scenarios and solutions for PTM problems
Scenarios Solutions
Message: “Communicator Not Found”
The PTM does not connect to the pump when requesting a bolus.
1. Follow on-screen
instructions for troubleshooting.
2. Unplug the communicator
from the charging cord. The communicator will not connect to the pump while it is charging.
3. If the problem persists,
SWITCH
tap COMMUNICATOR to refresh the connection.
The pump is not paired with this handset.
The HOME screen with the
Deliver Bolus
button
is not
available.
The app is not paired with the pump. Contact your clinician for help with pairing the PTM with the pump.
1. Look at the bottom of the
HOME screen to nd out
if any boluses are left for the day.
2. Find out if a lockout
is active. From the HOME screen with the countdown timer, tap the information button
next to the word Lockout. A message explains the reason why the bolus is not available.
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Troubleshooting
Table 5: Scenarios and solutions for PTM problems
Scenarios Solutions
3. The countdown timer shows how much time remains until the next bolus is available.
Dose restriction interval is currently active
Communication error. Retry communication.
A lockout is active. Wait until
the lockout is nished. Repeat
the bolus request.
The myPTM app stopped communicating with the pump before the bolus was started.
1. Make sure that the communicator is turned on and charged.
2. Repeat the bolus request.
3. If the issue persists, contact Medtronic for assistance.
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PART FOUR: Replacing the PTM
and Getting Help

Replacing the PTM and Disposal

Replacing the PTM and Disposal

Replacing the PTM

If the PTM is lost, stolen, or broken, contact Medtronic to order replacements and appropriately dispose of the handset. Medtronic can help you delete your personal and health data. Contact information is found in “How to contact Medtronic” on page 42.
When you receive the replacement PTM, refer to “Pairing Replacement Parts with the Pump” on page 39 for instructions about pairing the new PTM with your pump.
Note: If you need help to pair the new PTM with the pump, contact your clinician for help.

PTM disposal

Contact Medtronic when you no longer need your PTM. Medtronic can help you delete your personal and health data, and appropriately dispose of the handset.
Contact information is found in “How to contact Medtronic” on page 42.
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Pairing Replacement Parts with the Pump

Pairing Replacement Parts with the Pump
Follow these steps to pair a new PTM with your pump. The PTM must be paired with the pump before requesting a bolus.
Note: For help with problems pairing the new PTM, refer to “Troubleshooting” on page 32 or contact your clinician.

Pairing the replacement handset and communicator with the pump

Follow these steps to pair the replacement handset or both the handset and communicator with the pump.
Make sure that the handset and communicator are turned on and charged. Place the communicator directly over the pump.
1. Open the myPTM app ( open.
2. When the myPTM app says that no pump is paired with the handset, tap PAIR TO PUMP.
3. After the myPTM app nds the communicator, select the communicator serial number by tapping the check box.
Note: Ensure the serial number found on the back of the communicator is identical to the serial number displayed in the myPTM app. If the serial numbers are not identical, contact your clinician.
4. Press CONTINUE.
Note: If the myPTM app does not nd the
communicator, select RETRY.
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) if it is not already
Pairing Replacement Parts with the Pump
5. Ensure the pump serial number displayed in the myPTM app is identical to the pump serial
number found on your patient identication
card. If the serial numbers are not identical, contact your clinician.
6. Tap COMPLETE PAIRING to pair the handset, communicator, and the pump.

Pairing the replacement handset only

Refer to “Pairing the replacement handset and communicator with the pump” on page 39 for pairing directions.

Pairing the replacement communicator only

Follow these steps to pair the replacement communicator with the pump, while using the same handset.
Make sure that the handset and communicator are turned on and charged. Place the communicator directly over the pump.
1. Open the myPTM app (
Note: If you see the HOME screen, select the menu button
2. The myPTM app automatically searches for the paired communicator.
3. When the myPTM app says that the communicator is not found, tap
COMMUNICATOR.
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. Tap Resync.
).
SWITCH
Pairing Replacement Parts with the Pump
4. After the myPTM app nds the communicator, select the communicator serial number by tapping the check box.
Note: Ensure the serial number found on the back of the communicator is identical to the serial number displayed in the myPTM app. If the serial numbers are not identical, contact your clinician.
5. Press CONTINUE to pair the handset, communicator, and the pump.
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Getting Help with the PTM

Getting Help with the PTM

When to call your clinician

When you have questions about when you
can request your rst bolus, the prescribed
number of boluses per day or the lockout duration.
■ When directed by an alert message in the myPTM app. Refer to “myPTM app alert messages” on page 30 for instructions on
how to nd alert messages.
■ When you need help to pair replacement parts of the PTM with the pump.
If you observe symptoms of drug overdose or withdrawal, seek immediate medical attention.
Refer to the infusion system patient manual for more information about pump alarms, symptoms, and other reasons to call your doctor.

How to contact Medtronic

For assistance in the US, call
+1 800 510 6735.
Outside the US, call the phone number found at the back of the guide.
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PART FIVE: Software Information

Software Information

Software Information

Data security

Your myPTM app uses data about your health and your medical device. This information is encrypted by the app and handset. The app does not protect
or encrypt les if you export them from the app. It also does not protect any personal les or data
you choose to store or access elsewhere on the handset.
You are ultimately responsible for protecting the data stored on the handset. Medtronic recommends the following actions:
■ Secure your handset by disabling the Wi-Fi connection when using the myPTM app.
■ Use a trusted, secure Wi-Fi network when Internet access is needed.
If you no longer need the handset to manage your therapy, refer to “PTM disposal” on page 38.

Supporting apps

There are other apps installed on the handset that support the Model A820 myPTM app. You do not need to open or use these apps.
The Model A901 Communication Manager app works with the myPTM app to manage communication between the handset and the pump. The Model A902 Patient Data Services app works with the myPTM app to retrieve data from the pump.
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Index

A
Abbreviations 11 Alarm 30 Alert messages 16
, 32
, 30,
31
B
Bolus 11, 13, 16, 22, 27 Buttons 11
C
Call your clinician 41 Cautions 16 Charging 22 Communicator 4
20, 22
, 24
, 16,
D
Description 20 Disposal 38 Drug prescription 26
E
Electromagnetic inter-
ference 14
, 34
G
Glossary 13
H
M
myPTM app 4, 20, 22
O
Overdose 17, 41
P
Position the PTM 4
Q
Quick start 4
R
Replacement 38 Resync 28
S
Safety information 16 Security 44 Storing the PTM 24
T
Therapy details 26 Troubleshooting 32 Tutorials 26
W
Warnings 16
Handset 4, 20 HOME screen 23 How does the myPTM
app work 20
Manufacturer
Medtronic, Inc. 710 Medtronic Parkway, Minneapolis, MN 55432-5604, 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. Suite 1106-11, 11/F, Tower 1, The Gateway, 25 Canton Road, Tsimshatsui, Kowloon, Hong Kong Tel. +852-2919-1300
*M969546A003*
© Medtronic 2019 All Rights Reserved
M969546A003 Rev B 2019-03-01
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