Abbott Neuromodulation SJMX599EPG External Pulse Generator User Manual 37 5284 015

Advanced Neuromodulation Systems Inc., dba. St. Jude Medical Neuromodulation Division External Pulse Generator 37 5284 015

Contents

User Manual Part 2

28
Securing the EPG
The following steps outline the suggested guidelines for securing the EPG to the patient:
1. Place the EPG into the provided pouch.
2. Remove the adhesive liner on the pouch flap.
3. Use the flap to secure the leads in place and seal the pouch.
NOTE:
The EPG meets the IP22 rating when sealed in the pouch.
4. Remove the adhesive liner on the back of the pouch and press the pouch onto the patient’s skin
until it is secure.
NOTE:
It is good practice to secure the EPG pouch away from the lead entry site bandaging.
NOTE:
Leave some slack in the leads or extensions when securing the EPG onto the patient.
5. Use additional medical tape to secure the pouch and leads or extensions further as needed.
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Programming the EPG
Use the clinician programmer app to program the system for the trial period. For information on using
the clinician programmer app for programming, refer to the clinician’s programming manual.
Caring for the EPG
The EPG is an important part of the neurostimulation system. This section provides tips and other
information about caring for the EPG.
Handling the EPG
Do not expose the EPG to prolonged direct sunlight.
Avoid exposing the EPG to sand, dust, and other environmental hazards.
Do not put heavy or sharp objects on the EPG.
Keep the EPG away from food and beverages, and avoid getting the EPG wet.
If the EPG does get wet, do not use it. Contact Customer Service at +1-972-309-8000 for help.
Cleaning the EPG
Using two PDI Sani-Cloths, wipe the EPG for 2 minutes front and back, then allow to air dry. Once
the EPG is dry, attach the header cap.
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NOTE:
Clean the EPG before attaching the header cap.
Clean the EPG by thoroughly wiping off its outer surface using the provided cleaning cloths. Do not
wipe over the stimulator port. Do not submerge the EPG or use a cloth that is soaking wet.
Never use ammonia, acidic, or alkaline cleaners or organic chemicals such as paint thinner,
acetone, propyl alcohol, or kerosene. They may damage surface finishes of the EPG.
Storing and Transporting the EPG
Store the EPG and batteries in a cool, dry place. Do not store the EPG or batteries in your car or
garage.
Transport the EPG in a carrying case.
If you are carrying the EPG in a briefcase or other carrying case, make sure no objects in the case
are pressing on the device.
Store paired EPGs and patient controllers together to reduce the number of times you need to set
up communication.
At the end of a trial, disable stimulation, clean the EPG, and attach the header cap before storing
the EPG.
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NOTE:
During a trial store the header cap for reuse.
Figure 11. EPG header cap
Service and Ordering Information
This section provides information for contacting Customer Service and for ordering replacement parts
and accessories.
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Customer Service Information
For help with a St. Jude Medical™ neuromodulation product, including technical service or repair,
contact Customer Service using the following information:
St. Jude Medical
6901 Preston Road
Plano, TX 75024
USA
+1 972 309 8000
+1 972 309 8150 Fax
St. Jude Medical
Coordination Center BVBA
The Corporate Village
Da Vincilaan 11 Box F1
1935 Zaventem
Belgium
+32 2 774 68 11
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Ordering Information
To order parts, contact Customer Service. Refer to the following list for model numbers.
Table 1. Ordering information for the EPG
Model
Description
3599 EPG kit
3032 Header Accessory kit
1212 Coin cell batteries
1917 Battery door
3013 MLTC
1210 Magnet
1203 Box of cleaning cloths
1216
EPG header cap
1213
Pouch with adhesive (5)
1214
Pouch without adhesive and belt (5)
1218 Carrying case
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Appendix A: Product Specifications
EPG with Header
The EPG (Model 3599) and EPG header (Model 3032) has the following physical specifications.
Table 2. EPG and EPG header specifications
Height 79.8 mm (3.14 in)
Width 57.2 mm (2.25 in)
Thickness 11 mm (0.433 in)
Weight (with batteries) 44 g (1.55 oz)
Volume 44.57 cc (2.72 cu in)
Power source Nonrechargeable CR2450 coin cell
Lead or extension compatibility 2 octrode
Expected service life 5 years
Storage temperature -25°C - 70°C (-13°F - 158°F)
Operating temperature 5°C - 40°C (41°F - 104°F)
Storage humidity up to 93% (noncondensing)
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Operating humidity 15% - 93% (noncondensing)
Storage pressure 70 - 106 kPa (10.2 - 15.4 psi)
Operating pressure 70 - 106 kPa (10.2 - 15.4 psi)
Table 3. Operating parameters for the EPG
Tonic Range Steps Burst Range Steps
Pulse width
50 - 500 µs
12 - 13 µs
50 - 1000 µs
50 µs
Frequency 2 - 200 Hz
200 - 500 Hz
500 - 1200 Hz
2 Hz
10 Hz
20 Hz
— —
Burst rate
frequency
— — 10 - 60 Hz 10 Hz
Intra-Burst
frequency
— — 250 - 500 Hz
500 - 1000 Hz
10 Hz
20 Hz
Amplitude 0 - 25.5 mA
(max 12 V)
0.1 - 1.0 mA 0 - 12.75 mA 0.05 - 1.0 mA
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NOTE:
The maximum current depends on the impedance, frequency, and pulse width settings.
Appendix B: Regulatory Statements
Declaration of Conformity
Hereby, St. Jude Medical declares that this medical device is in compliance with the essential
requirements and other relevant provisions of AIMD directive 90/385/EEC. For a copy of the declaration
of conformity, please contact Customer Service by mail at 6901 Preston Road, Plano, TX 75024, USA,
or by telephone at +1 972 309 8000.
Battery Disposal Guidelines
This device contains a battery and a label is affixed to the device in accordance with European Council
directives 2002/96/EC and 2006/66/EC. These directives call for separate collection and disposal of
electrical and electronic equipment and batteries. Sorting such waste and removing it from other forms
of waste lessens the contribution of potentially toxic substances into municipal disposal systems and
into the larger ecosystem. Return the device to St. Jude Medical at the end of its operating life.
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Statement of FCC Compliance
This equipment has been tested and found to comply with the limits for a Class B digital device,
pursuant to part 15 of the FCC rules. These limits are designed to provide reasonable protection against
harmful interference in a residential installation. This equipment generates, uses, and can radiate
radiofrequency energy and, if not installed and used in accordance with the instructions, may cause
harmful interference to radio communications. However, there is no guarantee that interference will not
occur in a particular installation. If this equipment does cause harmful interference to radio or television
reception, which can be determined by turning the equipment off and on, the user is encouraged to try
to correct the interference by one or more of the following measures:
Reorient or relocate the receiving antenna.
Increase the separation between the equipment and receiver.
Connect the equipment into an outlet on a circuit different from that to which the receiver is
connected.
Consult the dealer or an experienced radio/TV technician for help.
Operation is subject to the following two conditions:
This device may not cause harmful interference.
This device must accept any interference received, including interference that may cause
undesired operation.
Modifications not expressly approved by the manufacturer could void the user’s authority to operate the
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equipment under FCC rules.
Statement of Compliance With License-Exempt RSS Standard (Canada)
This device complies with Industry Canada license-exempt RSS standard(s). Operation is subject to the
following two conditions: (1) this device may not cause interference, and (2) this device must accept
any interference, including interference that may cause undesired operation of the device.
Antenna Guidance Statement (Canada)
Under Industry Canada regulations, this radio transmitter may only operate using an antenna of a type
and maximum (or lesser) gain approved for the transmitter by Industry Canada. To reduce potential
radio interference to other users, the antenna type and its gain should be chosen so that the equivalent
isotropically radiated power (EIRP) is not more than that necessary for successful communication.
Statement of Compliance With Interference-Causing Equipment
Standard (Canada)
This ISM device complies with Canadian ICES-001.
Identification Information for Product Registration
On the exterior of this equipment is a label that contains, among other information, a product identifier
in the following format:
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Table 4. Registration identification information
Description
FCC Registration Number PX2SJMX599EPG
Industry Canada (IC) Registration Number 8454A-SJMX599EPG
Product Classification Statement (CISPR 11, Class B)
This product is class B equipment, which is intended primarily for use in the domestic environment.
Wireless Technology Information
The following table summarized the technical details of the Bluetooth® low energy technology as it is
implemented in the device.
Table 5. Bluetooth low energy information
Bluetooth low energy
Antenna type Embedded ceramic antenna
Antenna dimensions 4 mm x 3 mm x 1.1 mm
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Modulation GFSK
Magnetic Field Strength (at 10 m distance) 0.000145 A/m maximum
Electric Field Strength 0.055 V/m maximum
Output power (EIRP*) 1 mW (0 dBm) typical, 10 mW (+10 dBm) maximum
Range 2 meters typical
Center frequency 2.44 GHz
Channel 40 logical channels
Bandwidth 2 MHz per channel
Data-rate 5 kbit/second
Data flow Bi-directional
Protocol BLE
*EIRP = Equivalent isotropically radiated power
Radio Transmitter, Cables, Transducers
The device contains a radio transmitter/receiver with the following parameters.
Radio transmitter parameters:
Frequency (range): 2.4000 to 2.4835 GHz
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Bandwidth (-15dB): 2.398 to 2.4855 GHz
Channel: 40 logical channels using AFH
Modulation: GFSK
Radiated output power: 10 mW (+10 dBm) maximum
Magnetic field strength: 0.000145 A/m
Duty Cycle: Variable, but low (< 5%)
Semi-duplex capability
The radio receiver in the device is using the same frequency and bandwidth as the transmitter.
Cables and transducers:
Cables and transducers are not used during normal use of the device nor while programming the
device.
Quality of Service for Wireless Technology
Bluetooth® low energy wireless technology enables communication between the EPG and the clinician
programmer or patient controller. The requirements for the quality of service (QoS) vary depending on
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the use environment (operating room, recovery room, and home environment).
After the clinician programmer or patient controller is paired with a generator, (Bluetooth symbol) is
visible on the clinician programmer or patient controller in the upper right-hand corner. When the BLE
connection is not active, the symbol is grayed out.
The raw BLE data rate is approximately 2.5 KB/sec and the effective data rate is approximately 1.5 - 2
KB/sec. Other requirements include a semi-duplex transmission with a required acknowledge, a
transmission latency in each direction (2x), and a receive-to-transmit mode (RX to TX) time. Data is
resent if not sent successfully. Each key press may transmit up to 8 data packets, depending on the
number of packets that need to be transmitted (i.e., if there is only one packet to transmit, only one
packet will be transmitted).
Wireless Security Measures
The wireless signals are secured through device system design that includes the following:
The generator will encrypt its wireless communication.
Only one patient controller or clinician programmer may communicate with the generator at the
same time.
A unique key for each unit that is checked during each transmission.
Built-in pairing that specifies valid and legitimate pairing among units.
Proprietary authentication in addition to the pairing procedure specified in Bluetooth low energy,
which includes an element of proximity.
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A proprietary algorithm that detects and prevents an unauthorized user from attempting to pair
with the generator.
Troubleshooting for Wireless and Coexistence Issues
If you experience issues with the wireless communication between the generator and the clinician
programmer or patient controller, try the following:
Decrease the distance between the devices
Move the devices so they share line of sight
Move the devices away from other devices that may be causing interference
Wait a few minutes and try connecting again
Do not operate other wireless devices (i.e., laptop, tablet, mobile phone, or cordless phone) at the
same time
NOTE:
Wireless communications equipment, such as wireless home network devices, mobile and
cordless telephones, and tablets, can affect the device.
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Appendix C: Electromagnetic Compatibility Guidelines
The EPG, hereafter the device, is medical equipment and should be used with the following guidance.
The device requires special precautions with regard to electromagnetic compatibility (EMC) and should
be used in accordance with the information provided in this manual.
The device is intended for use in the electromagnetic environment specified in the following tables. The
user should ensure that it is used in such an environment.
CAUTION:
The device complies with the limits for medical devices contained in IEC 60601-1-
2:2007-03, EN 55011:2009/A1:2010 (CISPR 11:2010), and ETSI EN 300 328 V1.8.1
(2012-06).
However, the device may cause radio interference or may disrupt the operation of
nearby equipment. It may be necessary to mitigate this effect by reorienting or
relocating the receiving device.
CAUTION:
To avoid increasing emissions or decreasing immunity from a device or system, use
only St. Jude Medical-approved components with this system. Do not use St. Jude
Medical components with other non-St. Jude Medical devices or systems.
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Table 6. Guidance and manufacturer’s declaration – electromagnetic emissions
Emissions Test
Compliance
Electromagnetic Environment Guidance
RF emissions
CISPR 11
Group 1 The device uses RF energy for its internal and system
interface functions. Its RF emissions are very low and are not
likely to cause any interference in nearby electronic
equipment.
RF emissions
CISPR 11 Class B The device is suitable for use in all establishments including
domestic establishments and those directly connected to the
public low-voltage power supply network that supplies
buildings used for domestic purposes.
Harmonic
emissions
IEC 61000-3-2
Not applicable
Voltage
fluctuations/
flicker emissions
IEC 61000-3-3
Not applicable
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Table 7. Guidance and manufacturer’s declaration – electromagnetic immunity
Immunity Test
IEC 60601
Test Level
Compliance
Level
Electromagnetic Environment Guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
±6 kV contact
±8 kV air
±6 kV contact
±8 kV air
Floors should be wood, concrete or ceramic
tile. If floors are covered with synthetic
material, the relative humidity should be at
least 30%.
Electrical fast
transient/burst
IEC 61000-4-4
±2 kV for power
supply lines
±1 kV for
input/output lines
Not applicable No guidance for battery-powered devices.
Surge
IEC 61000-4-5
±1 kV line to line
±2 kV line to
earth
Not applicable No guidance for battery-powered devices.
Voltage dips,
short
interruptions
IEC 61000-4-11
<5% UT
40% UT
70% UT
Not applicable No guidance for battery-powered devices.
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Immunity Test
IEC 60601
Test Level
Compliance
Level
Electromagnetic Environment Guidance
Power
frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
3 A/m 3 A/m Power frequency magnetic fields should be at
levels characteristic of a typical location in a
typical commercial or hospital environment.
Table 8. Guidance and manufacturer’s declaration – electromagnetic immunity
Immunity
Test
IEC
60601
Test
Level
Compliance
Level
Electromagnetic Environment Guidance
Conducted RF
IEC 61000-4-
6
3 Vrms
150 kHz
to
80 MHz
Not
applicable
Portable and mobile RF communications equipment should
be used no closer to any part of the device, including
cables, than the recommended separation distance
calculated from the equation applicable to the frequency of
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Immunity
Test
IEC
60601
Test
Level
Compliance
Level
Electromagnetic Environment Guidance
Radiated RF
IEC 61000-4-
3
3 V/m
80 MHz
to
2.5 GHz
20 V/m
the transmitter.
Recommended separation distance
d=0.18P 80 to 800 MHz
d=0.35P 800 MHz to 2.5 GHz
where P is the maximum output power rating of the
transmitter in watts (W) according to the transmitter
manufacturer and d is the recommended separation
distance in meters (m).
Field strengths from fixed RF transmitters, as determined
by an electromagnetic site survey,a should be less than the
compliance level in each frequency range.b
NOTE: At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE: These guidelines may not apply in all situations. Electromagnetic propagation is affected by
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absorption and reflection from structures, objects, and people.
a Field strengths from fixed transmitters, such as base stations for radio (mobile/cordless) telephones
and land mobile radios, amateur radio, AM and FM radio broadcast, and TV broadcast cannot be
predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF
transmitters, an electromagnetic site survey should be considered. If the measured field strength in the
location in which the device is used exceeds the applicable RF compliance level above, the device
should be observed to verify normal operation. If abnormal performance is observed, additional
measures may be necessary, such as reorienting or relocating the device.
b Over the frequency range 150 kHz and 80 MHz, field strengths should be less than 3 V/m.
Table 9. Guidance and manufacturer’s declaration – electromagnetic immunity (conducted RF and
radiated RF)
Immunity
Test
IEC
60601
Test
Level
Immunity
Compliance
Level
Electromagnetic Environment Guidance
Conducted RF
IEC 61000-4-
6
3 Vrms
150 kHz
to
80 MHz 3 Vrms
Portable and mobile RF communications equipment
should be used no closer to any part of the device than
the recommended separation distance.
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Immunity
Test
IEC
60601
Test
Level
Immunity
Compliance
Level
Electromagnetic Environment Guidance
Radiated RF
IEC 61000-4-
3
3 V/m
80 MHz to
2.5 GHz
3 Vrms Recommended separation distance
d=1.2√P
d=1.2√P (80 MHz to 800 MHz)
d=2.3√P (800 MHz to 2.5 GHz)
where P is the maximum output power rating of the
transmitter in watts (W) according to the transmitter
manufacturer and d is the recommended separation
distance in meters (m).
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site survey, should
be less than the compliance level in each frequency
range. Interference may occur in the vicinity of
equipment marked with the following symbol:
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NOTE: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE: Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless)
telephones and land mobile radios, amateur radio, AM and FM radio broadcast, and TV broadcast
cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to
fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field
strength of the location in which the device is used exceeds the applicable RF compliance level above,
the device should be observed to verify normal operation. If abnormal performance is observed,
additional measures may be necessary, such as re-orienting or relocating the device.
The device is intended for use in the electromagnetic environment in which radiated RF disturbances
are controlled. The customer or the user of the device can help prevent electromagnetic interference by
maintaining a minimum distance between portable and mobile RF communications equipment
(transmitters) and the device as recommended below, according to the maximum output power of the
communications equipment.
Table 10. Recommended separation distances between portable and mobile RF communications
equipment and the device
Rated Maximum
Output Power of
Transmitter (W)
Separation Distance According to Frequency of Transmitter (m)
150 kHz to 80 MHz
d=0.17P
80 to 800 MHz
d=0.18P
800 MHz to 2.5 GHz
d=0.35P
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Rated Maximum
Output Power of
Transmitter (W)
Separation Distance According to Frequency of Transmitter (m)
150 kHz to 80 MHz
d=0.17P
80 to 800 MHz
d=0.18P
800 MHz to 2.5 GHz
d=0.35P
0.01 0.12 0.02 0.04
0.1 0.37 0.06 0.11
1 1.16 0.18 0.35
10 3.67 0.55 1.11
100 11.6 1.75 3.5
NOTE: Wireless communications equipment, such as wireless home network devices, mobile and
cordless telephones, and walkie-talkies, can affect the device. Keep the device away from wireless
communication equipment at least the distance d as listed in the 800 MHz to 2.5 GHz column in the
above table.
NOTE: For transmitters rated at a maximum output power not listed above, the recommended
separation distance d in meters (m) can be estimated using the equation applicable to the frequency of
the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according
to the transmitter manufacturer.
NOTE: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE: These guidelines may not apply in all situations. Electromagnetic propagation is affected by
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absorption and reflection from structures, objects, and people.
Radio Frequency Information
The effective radiated power is below the limits as specified in:
USA: FCC 47 CFR Part 15:2012
Canada: RSS-210 Issue 8
Europe: ETSI EN 301 489 V1.9.2, ETSI EN 301 489-1 and ETSI EN 301 489-17
NOTE:
Maintain a reasonable distance between other electronic equipment and the device.
CAUTION:
The ISM band used by this device has been approved by the Federal Communications
Commission for unlicensed use. However, there is no guarantee that this device will not
receive interference or that any particular transmission from this device will be free
from interference.
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Appendix D: Symbols and Definitions
The following symbols are used in this document and on some of the products and packaging:
Symbol
Description
Caution, Consult Accompanying Documents
Denotes that the user must consult this document for important safety-related information
(This symbol is blue and white on the device.)
Consult instructions for use
Denotes device contains a type BF applied part to protect you from shock. The device is
internally powered and is intended for continuous operation.
Denotes that the device contains a radio-frequency (RF) transmitter, which may cause RF
interference with other devices near this device.
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Symbol
Description
Denotes to keep the device dry
Ingress protection rating for a device that is protected from the intrusion of solid foreign
objects as small as 12.5 mm in diameter and is protected from vertically dripping water
when the device is tilted at an angle up to 15 degrees
Denotes single use only
Denotes date of manufacture
Catalog number
Manufacturer
Denotes content, the number of items contained in the package
Code that uniquely identifies an inventory item
Serial number
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Symbol
Description
Lot number
Unique device identification number
Prescription use only
Denotes that this product shall not be treated as household waste. Instead it is the user’s
responsibility to return this product to St. Jude Medical for reprocessing.
By ensuring that this product is disposed of properly, you will help prevent potential
negative consequences for the environment and human health, which could be caused by
inappropriate waste handling of this product. The recycling of materials will help to
conserve natural resources.
For more information about how to return this product for recycling, please contact
St. Jude Medical.
Authorized European representative
European conformity
The EU notified body number for AIMD
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Symbol
Description
This device is listed by Nationally Recognized Testing Laboratory (NRTL) as certified.
Denotes compliance with AS/NZS standards: AS/NZS 4268:2003
Appendix E: CE Mark Date
Table 11. Year in which the CE mark was awarded.
Year
3599 2014
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St. Jude Medical, Inc.
Global Headquarters
One St. Jude Medical Drive
St. Paul, Minnesota 55117
USA
+1 651 756 2000
+1 651 756 3301 Fax
St. Jude Medical
6901 Preston Road
Plano, Texas 75024
USA
+1 972 309 8000
+1 972 309 8150 Fax
St. Jude Medical
Coordination Center BVBA
The Corporate Village
Da Vincilaan 11 Box F1
1935 Zaventem
Belgium
+32 2 774 68 11
+32 2 772 83 84 Fax
St. Jude Medical
Australia Pty. Limited
17 Orion Road
Lane Cove NSW 2066
Australia
+61 2 9936 1200
+61 2 9936 1222 Fax
sjm.com
*100110976-5*
OCT 2014
37-5284
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