Medtronic TM90P01 Instructions for Use

Communicator

Instructions for use

TM90

  Rx only

Medtronic, Medtronic logo, and Further, Together are
trademarks of Medtronic.

The BLUETOOTH® word mark and logos are
registered trademarks owned by Bluetooth SIG, Inc.
and any use of such marks by Medtronic is under
license.

Label Symbols

Explanation of symbols on products and
packaging. Refer to the appropriate product
to see symbols that apply.

Consult instructions for use

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

Class II equipment

ON-OFF (Stand-by)

REF

EC

REP

Reorder number

Authorized Representative in the
European Community

Do not dispose of this product in the
unsorted municipal waste stream.
Dispose of this product according to
local regulations. See http://
recycling.medtronic.com for
instructions on proper disposal of this
product.

TM90 2018-04-30  English 

Label Symbols

3

For USA audiences only

Rx only

Caution: Federal law (USA) restricts
this device to sale by or on the order
of a physician.

Manufacturer

Date of manufacture

Use by

IEC60601-1/EN60601-1, Type BF
equipment

Direct Current

MR

Magnetic Resonance (MR) Unsafe

Serial number

PIN number

Keep dry

-XX °C

-XX °F

+XX °C

+XXX °F

Temperature limitation

The Technical Conformity mark
signifies that this device complies with
Japan Radio Law.

Label Symbols

4

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The RCM Certification mark signifies
that this device complies with
Australia/NewZealand EMC
requirements for electrical and
electronic equipment.

Chinese Standard (SJ/T11364-2006)
Logo: Electronic Information Products
Pollution Control Symbol. (The "e" in
this logo signifies none of the
restricted substances are present
above permitted levels.)

The KCC Certification mark signifies
that this device complies with South
Korea's radio requirements for
telecommunication equipment.

TM90 2018-04-30  English 

Label Symbols

5

Label Symbols

6

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Table of contents

Label Symbols 3

 Introduction 10

1 

How to use this manual 10
Patient information 11
Purpose and description 11
Warnings 12
Precautions 12
How to contact Medtronic 13

2  Using the communicator 16

Package contents 16
How the communicator works 16
Instructions for use 17
Declaration of conformity 18
Communicator overview 19
Turning on the device 20
Connecting to the handset 21
Turning off the device 22
Charging the device 23

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Table of contents

7

3  Troubleshooting and device

care 28

Troubleshooting 28
Electromagnetic interference 28
Safety and technical checks 29
Device care 30
Specifications 31

Index 34

Table of contents

8

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1 Introduction

How to use this manual

This manual contains information for patients
and clinicians about the communicator
device. Please read the entire manual before
using the device.

Chapter 1 “Introduction” explains how to

•

use this manual, and provides patient
information. This chapter describes the
device and its purpose, and provides
warnings, precautions, and Medtronic
contact information.

Chapter 2 “Using the communicator” lists

•

items in the product package, and gives
instructions for using the device.

Chapter 3 “Troubleshooting and device

•

care” provides information on
electromagnetic interference (EMI),
troubleshooting, and tips on caring for the
device. This chapter also provides
specifications, and information on who to
call for assistance.

Introduction 1

10

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Patient information

You should have received additional manuals
specific to your therapy. Review these
materials, and keep them in a convenient
location.

Purpose and description

The Medtronic Model TM90 Communicator is
intended for patient or clinician use, to
connect the app installed on the Model HH90
handset to the implanted medical device.

The app on the handset interacts with the
implanted medical device through the
communicator.

The communicator contains a lithium-ion
battery that will need to be regularly charged.
The communicator can be used in a home or
health care setting.

For complete information, refer to the therapy
manuals associated with your medical
device.

TM90 2018-04-30  English 

Introduction 1

11

Warnings

Sterile field—Avoid using the device in a

sterile field. If it is necessary, place the
device into a sterile bag or use a sterile
barrier. The device is not sterile and cannot
be sterilized. Failure to use a sterile bag or
barrier may cause an infection.

Wound contact—Do not use the device on
an unhealed wound. Place a sterile bandage
or barrier between the wound and device.
The device is not sterile. Contact with the
wound without a sterile bandage or barrier
may cause an infection.

Precautions

Disposal—Dispose of the communicator

according to local regulations, or consult
http://recycling.medtronic.com. Failure to
dispose of the device correctly may lead to
environmental damage.

Introduction 1

12

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