Medtronic TM90 Communicator User Manual Users manual

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Document ID	3647275
Application ID	J5N0rJnqdpl9bQv9Ova+3Q==
Document Description	Users manual
Short Term Confidential	No
Permanent Confidential	No
Supercede	Yes
Document Type	User Manual
Display Format	Adobe Acrobat PDF - pdf
Filesize	320.79kB (4009881 bits)
Date Submitted	2017-11-21 00:00:00
Date Available	2017-11-22 00:00:00
Creation Date	2017-09-07 08:47:54
Producing Software	Acrobat Distiller 15.0 (Windows)
Document Lastmod	2017-09-07 08:47:54
Document Title	Users manual
Document Creator	AH Formatter V6.2 MR10 (6,2,2015,0721) for Windows
Document Author:	whalej1

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Communicator
Instructions for use
Rx only
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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.
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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
REF
Reorder number
EC REP
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.
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Label Symbols
ON-OFF (Stand-by)
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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
Magnetic Resonance (MR) Unsafe
MR
Serial number
PIN number
Label Symbols
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.
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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.)
Label Symbols
The KCC Certification mark signifies
that this device complies with South
Korea's radio requirements for
telecommunication equipment.
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Table of contents
Label Symbols 3
1 Introduction 10
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
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Table of contents
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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3 Troubleshooting and device
care 28
Troubleshooting 28
Electromagnetic interference 28
Safety and technical checks 29
Device care 30
Specifications 31
Table of contents
Index 34
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1 Introduction
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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
Introduction 1
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.
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.
For complete information, refer to the therapy
manuals associated with your medical
device.
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Introduction 1
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.
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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.
Introduction 1
Precautions
12
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.
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How to contact Medtronic
Introduction 1
For assistance in the US, call
+1 800 510 6735. Outside the US, call the
phone numbers found at the back of the
manual.
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2 Using the
communicator
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Package contents
The Medtronic Model TM90 Communicator
package contains the following parts:
• Model TM90 Communicator
• Product literature
The USB charging cable and AC adaptor are
included in the handset package. Use this
cable or another USB 2.0 compliant cable to
charge the device.
Using the communicator 2
How the communicator works
16
The communicator acts as a wireless "bridge"
between the app installed on the handset,
and the implanted medical device. The
implanted device only accepts
communications from the app through the
communicator.
Sending information between the app and
implanted device, through the communicator,
will only occur after the app and
communicator have been "paired". Pairing
will take place before first use of the app.
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For a new communicator that has not been
paired with the app, or for any other reason
the communicator is not paired with the app,
refer to the app user guide for pairing
instructions or troubleshooting.
Instructions for use
This section provides instructions for turning
the communicator on and off, connecting it to
the handset, and charging the communicator.
Notes:
• Allow 15 minutes for the communicator to
warm up before use, after being stored at
the minimum storage temperature.
• Allow 15 minutes for the communicator to
cool down before use, after being stored
at the maximum storage temperature.
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Using the communicator 2
For instructions on connecting the
communicator and app with the implanted
device, refer to the appropriate app user
guide that is included in the communicator
package.
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During a therapy session, hold the
communicator over the implanted device, no
more than 4 cm away from the body.
If the communicator warms during a therapy
session, and this is uncomfortable against
your skin, place a thin layer of clothing
between the communicator and skin.
For additional guidance on how and where to
place the communicator, refer to the app user
guide that is included in the communicator
package.
Using the communicator 2
Declaration of conformity
18
Medtronic declares that the Medtronic
Model TM90 Communicator is in conformity
with the essential requirements of Directive
90/385/EEC on Active Implantable Medical
Devices.
For additional information, call the
appropriate phone number found at the back
of this manual.
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Communicator overview
USB charging cable
Battery indicator
BLUETOOTH® technology indicator
Power (Stand-by) button
The communicator includes a power button
and USB charging port. A battery indicator
light shows when the battery is low (yellow),
charging (orange), or fully charged (green).
The BLUETOOTH® technology indicator light
(blue) shows if the communicator is
connected to the handset.
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Using the communicator 2
Figure 2.1 Communicator
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Turning on the device
Power button
Press the power button until the
blue light blinks.
Using the communicator 2
Figure 2.2 Turn the power on
20
The ON-OFF (Stand-by) symbol ( ) on the
power button lights up when the device is on.
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Connecting to the handset
BLUETOOTH® technology indicator
(blue)
The blue light blinks until the
communicator connects to the
handset and the app.
The light turns solid blue when the
communicator is connected.
The blue light provides information on
connection status between the communicator
and the app on the handset.
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Using the communicator 2
Figure 2.3 BLUETOOTH® technology indicator
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Turning off the device
Power button
Press the power button for at
least 3 seconds or until the lights
turn off.
Note that the communicator will
turn off after 3 minutes if not
connected to the handset.
Using the communicator 2
Figure 2.4 Turn the power off
22
The power button and indicator lights turn off.
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Charging the device
Battery indicator (yellow)
The battery indicator turns yellow
when the battery has a low
charge.
The communicator will not connect
to the implanted device while it is
charging.
A yellow battery indicator light means that it is
time to charge the communicator.
Use the USB charging cable and AC adaptor
included in the handset package, or another
USB 2.0 compliant cable.
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Using the communicator 2
Figure 2.5 Low battery
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For best results, charge the communicator
overnight, so it is fully charged and ready for
use at the beginning of the day.
USB charging cable
Battery indicator (orange)
Insert the USB charging cable into the
communicator charging port.
Connect the AC adaptor on the other
end to a power source or wall outlet.
Using the communicator 2
The battery indicator turns orange
when the battery is charging.
24
Figure 2.6 Charging the battery
While charging, the device will turn off after
3 minutes, if it is not communicating with the
handset. The communicator will continue to
charge.
Press the power button to turn off the
communicator immediately. It will continue to
charge while off.
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A green battery indicator light means that the
communicator is fully charged, and ready for
use.
USB charging cable
Battery indicator (green)
Figure 2.7 Fully charged battery
When the device is disconnected from the
power source, the battery indicator light and
power light will turn off.
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Using the communicator 2
The battery indicator turns green when
fully charged. It remains green until the
communicator is removed from the
power source.
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Troubleshooting
and device care
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This chapter provides information on
troubleshooting, electromagnetic interference
(EMI), and care for the communicator device.
This chapter also provides specifications, and
information on who to call for assistance.
Troubleshooting
While charging, the communicator will not
connect to the implanted medical device.
Troubleshooting and device care 3
Use of the communicator is specific to the
medical device. Refer to the app user guide
to troubleshoot possible issues while using
the communicator with the app.
28
Software updates are sent to the
communicator if needed.
For assistance or questions, refer to "How to
contact Medtronic" on page 13.
Electromagnetic interference
Electromagnetic interference (EMI) is a field
of energy made by equipment found in the
home, work, medical, or public environments.
EMI may be strong enough to interfere with
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the connection between the handset and
implanted device.
Refer to the app user guide included in the
communicator package, for more information
on EMI.
The therapy manuals associated with your
medical device will also provide information
about sources of EMI and advice on how to
avoid this type of interference.
Safety checks are not required for the
Model TM90 Communicator. Maintenance is
not necessary, because the communicator
does not contain serviceable components.
If the communicator or handset was lost or
damaged, call Medtronic for further
assistance.
Refer to "How to contact Medtronic" on
page 13 or refer to the back cover of the
manual.
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Safety and technical checks
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Device care
Follow these guidelines to ensure that the
communicator operates properly.
• Charge the communicator at least every 6
months, even if it is not in use, to ensure
the battery maintains power.
• Clean the communicator with a damp
cloth or sponge. Mild household or
medical cleaners will not damage the
device.
• Clinicians should clean the device
Troubleshooting and device care 3
between uses on different patients.
30
• Keep the device and USB charging cable
out of the reach of children and pets.
• Follow all warnings and the precaution in
this manual.
• Handle the device with care. Do not drop,
strike, or step on it.
• Do not dismantle or tamper with the
device.
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• The communicator is not waterproof. Do
not allow moisture to get inside of the
device.
Specifications
Item
Power source
Specification
Rechargeable battery, USB 2.0
compliant cable with external
power supply
Battery life Clinician use
2 hours per day with power on
Battery life Patient use
30 minutes per day with power on
Service life
2 years minimuma
Operating
temperature
5°C to 40°Cbc
(41°F to 104°F)
Storage
temperature
-25°C to 70°Cd
(-13°F to 158°F)
Size
(approximate)
60.25 mm x 121.25 mm x 9.35 mm
(2.4 in x 4.8 in x .37 in)
Weight, including 57 g (2 oz)
batteries
(approximate)
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Table 3.1 Communicator
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Table 3.1 Communicator (continued)
Item
Mode of
operation
Specification
Continuous
Classification
Internally powered
Case material
Polycarbonate/ABS blend plastic
resin
Troubleshooting and device care 3
a Communicator
32
can continue to be used after the
minimum service life has elapsed.
b A relative humidity range of 15% to 90%, noncondensing, but not requiring a water vapour partial
pressure greater than 50 hPa; and an atmospheric
pressure range of 700 hPa to 1060 hPa.
c At the upper range of operating temperature, the
communicator may reach 43°C (109°F).
d 5°C to 35°C at a relative humidity up to 90%, noncondensing; and >35°C to 70°C at a water vapour
pressure up to 50 hPa.
Table 3.2 Charger
Item
Rated Input
Specification
100-240V ~ 50-60Hz, 0.15A
Rated Output
5.0V
Isolation Mark
Class II equipment
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Table 3.2 Charger (continued)
Item
Certification
Specification
Agency certified
Charging Cord
Micro USB 2.0 standard compliant
Troubleshooting and device care 3
a Minimum
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Index
Index
34
BLUETOOTH® technology indicator 21
Charging the battery 24
Cleaning the device 30
Components 16
Contacting Medtronic 13
Device care guidelines 30
Disposal
Recycling 12
Electromagnetic interference 28
Fully charged battery 25
Indicator lights 19
Low battery charge 23
Pairing 16
Placement of the communicator 18
Power button 20, 22
Replacement 29
Software updates 28
Specifications 31, 32
Sterile field 12
System components 16
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Index
Temperature
Operating 31
Storage 17, 31
Troubleshooting 28
USB charging cable 16, 23, 30
AC adaptor 16
Wound contact 12
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Contacts:
Asia: Medtronic International Ltd.
Tel. 02919-1300
Australia: Medtronic Australasia P/L
Tel. +61-2-9857-9000
Toll-free 1-800-668-670
Austria: Medtronic Österreich GmbH
Tel. 01-240440
Belgium: Medtronic Belgium S.A.
Tel. 02-456-0900
Canada: Medtronic of Canada Ltd.
Tel. (1-905)-460-3800
Czech Republic: Medtronic Czechia
s.r.o.
Tel. 2-330-591-11
Denmark: Medtronic Danmark A/S
Tel. 45-32-48-18-00
Finland: Medtronic Finland Oy/LTD
Tel. (09) 207-281-210
France: Medtronic France S.A.S.
Tel. 01-5538-1700
Germany: Medtronic GmbH
Tel. (02159)-81490
Greece: Medtronic Hellas S.A.
Tel. 210-67-79-099
Hungary: Medtronic Hungária Kft.
Tel. 1-889-06-00
Ireland: Medtronic Ireland Ltd.
Tel. (01) 511-1400
Italy: Medtronic Italia SpA
Tel. 02-241371
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Japan: Medtronic Japan
Tel. 03-6776-0017
Latin America: Medtronic, Inc.
Tel. (1305)-500-9328
Norway: Medtronic Norge AS
Tel. 67-10-32-00
Poland: Medtronic Poland Sp. z.o.o.
Tel. (022)-465-69-00
Portugal: Medtronic Portugal, Lda.
Tel. 21-724-5100
Russia: Medtronic Russia
Tel. (7495) 580-7377
Slovakia: Medtronic Slovakia, o.z.
Tel. 0268 206 911
Spain: Medtronic Ibérica, S.A.
Tel. 91-625-0400
Sweden: Medtronic AB
Tel. 08-568-585-00
Switzerland: Medtronic (Schweiz) AG
Tel. 031-868-0100
The Netherlands: Medtronic B.V.
Tel. (045)-566-8000
Turkey: Medtronic Turkey
Tel. +90 216 636 1000
U.K.: Medtronic U.K. Ltd.
Tel. 01923-212213
USA: Medtronic, Inc.
Tel. (1-763)-505-5000
Toll-free: (1-800)-328-0810
Filename Date Time
UC200xxxxxx EN
4.6 x 6 inches (118 mm x 152 mm)
M966423A001
Rev D 2018-04-30
Medtronic Confidential
PPManual.xsl - PatientProgrammerTemplate.fm
Template version 6.2: 06-14-2017
Filename Date Time
UC200xxxxxx EN
4.6 x 6 inches (118 mm x 152 mm)
Medtronic Confidential
PPManual.xsl - PatientProgrammerTemplate.fm
Template version 6.2: 06-14-2017
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
EC REP
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-Pacific
Medtronic International Ltd.
Suite 1106-11, 11/F, Tower 1, The Gateway,
25 Canton Road, Tsimshatsui,
Kowloon,
Hong Kong
Tel. +852-2919-1300
Contacts for specific countries are listed inside this cover.
*M966423A001*
M966423A001
Rev D 2018-04-30
© Medtronic, Inc. 2018
All Rights Reserved
M966423A001 Rev D

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