Medtronic 97715, 97716 User Manual

Filename Date Time
UC200xxxxxx EN

4.6 x 6 inches (117 mm x 152 mm)

Intellis™ 97715

Rechargeable neurostimulator

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Implant manual

! USA

Rx only

2012

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4.6 x 6 inches (117 mm x 152 mm)

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Explanation of symbols on product or package labeling

Refer to the appropriate product for symbols that apply.

Conformité Europ éenne (European Conformity). This symbol means that the
device fully complies with AIMD Directive 90/385/EEC (NB 0123) and
R&TTE Directive 1999/5/EC.

Warning

Consult instructions for use

Do not reuse

Do not resterilize

2

STERILIZE

Date of manufacture

Manufacturer

Open here

Use by

Serial number

Medtronic Confidential

STERILE

EC

! USA

XXX °F

-XX °C

-XX °F

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Sterilized using ethylene oxide

EO

Authorized Representative in the European Community

REP

For USA audiences only

XX °C

Temperature limitation

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Medtronic® and SoftStart/Stop® are trademarks of Medtronic, Inc., registered in the U.S. and
other countries.

AdaptiveStim™ and Intellis™ are trademarks of Medtronic, Inc.

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Table of contents

Description 5

Package contents 5

Patient identification card 5

Device specifications 5

Declaration of conformity 8

Instructions for use 9

Charging the neurostimulator battery 9
Verifying neurostimulator operation 9
Connecting the extension or lead to the neurostimulator 10
Implanting the neurostimulator 11
Checking system integrity 12
Completing the implant procedure 12

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Refer to the indications sheet for indications and related information.

Refer to the appropriate information for prescribers booklet for contraindications,
warnings, precautions, adverse events summary, individualization of treatment,
patient selection, use in specific populations, resterilization, and component
disposal.

Refer to System Eligibility, Battery Longevity, Specifications reference manual for
neurostimulator selection, battery longevity calculations and specific
neurostimulator specifications.

Refer to the clinical summary booklet for information on the clinical study

results of the neurostimulation system and individualization of treatment.

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Description

The Medtronic Intellis Model 97715 Neurostimulator is part of a neurostimulation system for
pain therapy.

Package contents

Neurostimulator

▪

Torque wrench

▪

Pocket sizer

▪

Bore plugs (2)

▪

Product literature

▪

Registration form

▪

Patient identification card

▪

Warranty card

▪

Patient identification card

A patient identification card is packaged with this device. Advise the patient to carry the
identification card at all times.

! USA

The patient identi fication card packaged with the de vice is temporary; a permanent card

will be mailed to the patient when Medtronic receives the registration form.
The implant registra tion form registers the device warranties and creates a record of the device

in Medtronic’s implant data system.

Device specifications

The neurostimulator is a multi-programmable, rechargeable device that delivers stimulation
through 1 or more leads. The stimulation settings are stored in programs to target pain areas.
A program is a specific combination of pulse width, rate, and intensity settings acting on a
specific electrode combination (up to 16 electrodes per program). Up to 4 pain areas can be
targeted by programs. When stimulating more than one pain area, the pulses are delivered
sequentially—first a pulse from one program, then a pulse from the next program.

Date, pulse width, intensity, cycling, and electrode polarity for each program within the group
can have different values. Rate, rate limits, pulse width and intensity limits, and ramping for
each program within the group have the same values.

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Table 1. Operating values for the Intellis Model 97715 Neurostimulator

Programmable parameter

Operating values and ranges

a

Number of defined groups 1-3 (optional)
Number of programs per pain

area

1-3

Number of programs 12
Number of pain areas 1-4
Electrode configuration 2-16 electrodes as anode, cathode, or Off
Maximum intensity per

electrode

0-25.5 mA (0.1 mA increment)

Program intensity 0-100 mA
Intensity – limits Enabled or disabled at maximum of 25.5 mA per electrode
Pulse width 60-1000 µs (10-µs increment)

Pulse width – limits

Master rate

a

b

Enabled or disabled at maximum of 1000 Hz

10-1200 Hz (increment: 1 Hz from 10-30 Hz, 5 Hz from
30-250 Hz, 10 Hz from 250-500 Hz, 20 Hz from 500-1000 Hz,

50 Hz from 1000-1200 Hz)
Rate ratio A fraction of the master rate (1/1, 1/2, 1/3, 1/4, 1/5)
Rate limits

Enabled or disabled (at maximum of 1200)

a

SoftStart/Stop Off, On: 1, 2, 4, or 8 second ramp duration

c

Cycling

AdaptiveStim

a

Rate availability depends on how many pain areas are defined. For example, the maximum rate available in
one defined pain area is 1200 Hz. The maximum rate available if two pain areas are defined is 600 Hz in
each of those two pain areas.

b

Pulse width limits are not available when AdaptiveStim is enabled.

c

Cycling is not available for pain areas with AdaptiveStim enabled.

Off, On: 0.1 s-30 min (resolution: 0.1 s from 0.1-1 s, 1 s from 1

s-1 min, 1 min from 1-30 min)

Off, On: 7 positions

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Table 2. Physical characteristics of the Intellis Model 97715 Neurostimulator

Description Value

Connector type Octapolar, in-line 2.8-mm (0.110-in) spacing
Height 57.0 mm (2.1 in)
Width 47.3 mm (1.9 in)
Thickness

case 6.3 mm (0.2 in)

connector 8.9 mm (0.4 in)
Weight 29.9 g (1.1 oz)
Volume

13.7 cm

3

Battery life 9 years before ERI
Power source Lithium ion rechargeable battery
Storage temperature –18 °C to +52 °C (0 °F to +126 °F)

Serial number model designator

b

Radiopaque identification (ID) code

a

All measurements are approximate.

b

The serial number is the model designator followed by a number. The clinician programmer displays the
entire serial number beginning with the model designator.

NME

NME

a

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Table 3. Material of components in the Intellis Model 97715 package

Components

Material Material contacts

human tissue

Neurostimulator

Case Titanium Yes
Connector block Titanium, polysulfone, silicone

rubber, silicone medical adhesive

Yes

Grommets, seals Silicone rubber Yes
Setscrews Titanium alloy Yes
Adhesive Silicone medical adhesive Yes
Pocket sizer Polypropylene Yes
Bore plug Silicone rubber; stainless steel Yes

Torque wrench

Handle Polyetherimide Yes
Shaft

Stainless steel Yes

Declaration of conformity

Medtronic declares that t his product is in conformity with the es sential requirements of Directive
1999/5/EC on Radio and Telecommunications Terminal Equipment and Directive 90/385/EEC
on Active Implantable Medical Devices.

For additional info rmation, contact the appropriate M edtronic representative listed on the in side
back cover of this manual.

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Instructions for use

Implanting physicians should be experienced in epidural-access procedures and should be
thoroughly familiar with all product labeling.

w

Warning: DO NOT use the recharger on an unhealed wound. The recharging system
is not sterile, and contact with the wound can cause an infection.

#

Caution: If the neurostimulator is not being used for an extended period of time,
recommend that your patient charge the neurostimulator at least once per year. If the
battery is discharged, stimulation will stop and the neurostimulator may not
communicate with the controller.

#

Caution: Advise patients to charge the neurostimulator when a low battery message is
displayed on the controller in order to maintain uninterrupted therapy from the
neurostimulator. If the battery is discharged, stimulation will stop and the
neurostimulator may not communicate with the controller.

Note: The patient will be able to use the controller and recharger to charge a discharged
battery without causing damage to the battery or the neurostimulator.

#

Cautions:

▪

When using sharp instruments near the neurostimulator, be extremely careful to
avoid nicking or damaging the case, the insulation, or the connector block.
Damaging the neurostimulator may require surgical replacement.

▪

Do not use saline or other ionic fluids at connections, which could result in a short
circuit.

Charging the neurostimulator battery

Check the battery level of the neurostimulator before opening the package, and recharge the
neurostimulator if the battery is low. For charging instructions, refer to the recharging system
user manual. If the patient will be sent home with stimulation on, charge the neurostimulator
in the package before implant.

Verifying neurostimulator operation

Before opening the sterile neurostimulator packa ge, verify that the neurostimulato r is operable
by using the clinician programmer to interrogate the neurostimulator and read the
neurostimulator battery charge level. (Refer to the programming guide for instructions on how
to read the battery charge level.)

#

Caution: Do not implant a neurostimulator if it was dropped onto a hard surface from a
height of 30 cm (12 in) or more, because the neurostimulator may be damaged and fail
to operate properly.

Note: The neurostimulator pocket may be flushed with an antibiotic solution; do not submerge
the neurostimulator in fluid.

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Connecting the extension or lead to the neurostimulator

#

Caution: Before connecting components, wipe off any body fluids and dry all

connections. Fluids in the connection may result in stimulation at the connection site,

intermittent stimulation, or loss of stimulation.

1. Wipe the extension or lead connector pins with sterile gauze. If necessary, use sterile
(United States Pharmacopeia [USP]) water or a nonionic antibiotic solution.

2. Make sure the connector block receptacles are dry and clean.

3. Insert the appropriate extension or lead connector pins into the appropriate

neurostimulator socket until they are seated fully within the connector block (Figure 1).

Notes:

During insertion, some resistance is typical.

▪

To retract the setscrews, insert the torque wrench into the self-sealing grommet and

▪

rotate the setscrews counterclockwise; however, do not remove the setscrews from
the connector block.

#

Caution: Do not insert the extension or lead connector into the connector block if
the setscrews are not sufficiently retracted. If the setscrews are not retracted, the
setscrews may damage the extension or lead and the extension or lead will not be
seated fully into the connector block.

Socket I (Electrodes 0-7)

Socket II (Electrodes 8-15)

Extension or Lead 1

Extension or Lead 2

Figure 1. Insert the extension or lead connector pins fully into the neurostimulator.

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Note: Insert a connector plug (from an accessory kit) into any unused neurostimulator
socket.

4. For each extension, lead, or plug, fully insert the torque wrench (packaged with the

rechargeable neurostimulation system) into each self-sealing grommet of the connector
block and tighten each setscrew (Figure 2).

#

Cautions:

▪

Be sure the torque wrench is fully inserted into the self-sealing grommet. If the
torque wrench is not fully inserted, the setscrew may be damaged, resulting
in intermittent or loss of stimulation.

▪

Before tightening setscrews, ensure that the extension or lead connector pins
are inserted into the connector block to prevent damaging the lead or
extension.

▪

Verify that each leaf of the self-sealing grommet is closed after the torque
wrench is withdrawn. If fluid leaks through a grommet seal that is not fully
closed, the patient may experience shocking, burning, or irritation at the
neurostimulator implant location, or intermittent stimulation, or loss of
stimulation.

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Figure 2. Tightening the setscrews in the self-sealing grommet.

Implanting the neurostimulator

1. Place the neurostimulator into the subcutaneous pocket using the pocket sizer if desired

and ensure that the extension or lead is not bent sharply. The neurostimulator can be
implanted and charged with either side facing outward. for optimal recharging, place the
neurostimulator within 1-2 cm (0.8 in.) of the skin surface.

#

Cautions:

▪

Ensure that the neurostimulator is placed no deeper than 3 cm (1.2 in) below
the skin and is parallel to the skin. If the neurostimulator is too deep or is not
parallel to the skin, recharge may be inefficient or unsuccessful.

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▪

Do not coil excess extension in front of the neurostimulator. Wrap excess
extension or leads around the perimeter (Figure 3) or behind the
neurostimulator to help minimize potential damage during neurostimulator
replacement surgery, help minimize potential kinking of the extension or lead,
and minimize interference with telemetry and recharge operation.

Figure 3. Wrap excess extension around the perimeter of the neurostimulator.

2. Use the suture holes in the connector block to secure the neurostimulator to the muscle
fascia with nonabsorbable silk.

Note: Secure the neurostimulator in the pocket to minimize movement or migration of
the neurostimulator.

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Checking system integrity

The connections of the extensions and leads to the neurostimulator can be checked using the
clinician programmer. Refer to the programming guide for detailed programming
instructions.

w

Warning: To use the nonsterile programmer system components in a sterile field, place
a sterile barrier between the patient and system components to prevent infection. Do not
sterilize any components of the programmer system. Sterilization may damage the
components.

1. To ensure proper connection of each extension or lead to the neurostimulator, use the
clinician programmer to perform the lead insertion check.

2. If the lead insertion check results are not acceptable, refer to "Connecting the extension
or lead to the neurostimulator".

Completing the implant procedure

1. Close and dress all incisions.

2. Turn off stimulation before sending your patient home.

3. Ensure that a patient control device is given to the patient.

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4. Complete the device tracking and patient registration paperwork and return the

documents to Medtronic.

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Contacts:

Asia:

Medtronic International Ltd.
Tel. [phone]
Fax [phone]

Medtronic Asia Ltd.
Tel. [phone]

Fax [phone]

Australia:

Medtronic Australasia Pty. Ltd.
97 Waterloo Road
North Ryde, NSW 2113
Australia
Tel. [phone]
Fax [phone]
Toll free 1-800-668-6700

Austria:

Medtronic Österreich GmbH
Tel. [phone]
Fax [phone]

Belgium:

Medtronic Belgium S.A.
Tel. [phone]
Fax [phone]

Canada:

Medtronic of Canada Ltd.
Tel. [phone]
Fax (1905)-826-6620

Czech Republic:

Medtronic Czechia s.r.o.
Tel. [phone]
Fax [phone]

Denmark:

Medtronic Danmark A/S
Tel. [phone]
Fax [phone]

Finland:

Medtronic Finland Oy/LTD
Tel. [phone]
Fax [phone]

France:

Medtronic France S.A.S.
Tel. [phone]
Fax [phone]

Germany:

Medtronic GmbH
Tel. [phone]
Fax [phone]

Greece:

Medtronic Hellas S.A.
Tel. [phone]
Fax [phone]

Hungary:

Medtronic Hungária Kft.
Tel. [phone]
Fax [phone]

Ireland:

Medtronic Ireland Ltd.
Tel. [phone]
Fax [phone]

Italy:

Medtronic Italia SpA
Tel. [phone]
Fax [phone]

Tel. [phone]
Fax [phone]

Japan:

Medtronic Japan
Tel. [phone]
Fax [phone]

Latin America:

Medtronic, Inc.
Tel. [phone]
Fax [phone]

Norway:

Medtronic Norge AS
Tel. [phone]
Fax [phone]

Poland:

Medtronic Poland Sp. z.o.o.
Tel. [phone]
Fax [phone]

Portugal:

Medtronic Portugal, Lda.
Tel. [phone]
Fax [phone]

Russia:

Medtronic Russia
Tel. [phone]
Fax [phone]

Slovakia

Medtronic Slovakia, o.z.
Tel. [phone]
Fax [phone]

Spain:

Medtronic Ibérica, S.A.
Tel. [phone]
Fax [phone]

Sweden:

Medtronic AB
Tel. [phone]
Fax [phone]

2012-06

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Switzerland:

Medtronic (Schweiz) AG
Tel. [phone]
Fax [phone]

The Netherlands:

Medtronic B.V.
Tel. [phone]
Fax [phone]

U.K.:

Medtronic U.K. Ltd.
Tel. [phone]
Fax [phone]

USA:

Medtronic, Inc.
Tel. [phone]
Fax [phone]
Toll-free: (1-800)-328-0810

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Manufacturer

Medtronic, Inc.
710 Medtronic Parkway,
Minneapolis, MN 55432-5604,
USA.
www.medtronic.com
Tel. [phone]
Fax [phone]

Authorized Representative
in the European Community

Medtronic B.V.
Earl Bakkenstraat 10,
6422 PJ Heerlen,
The Netherlands
Tel. [phone]
Fax [phone]

Europe/Africa/Middle East
Headquarters

Medtronic International Trading Sàrl
Route du Molliau 31,
Case Postale 84
CH-1131 Tolochenaz,
Switzerland
www.medtronic.eu
Tel. [phone]
Fax [phone]

Asia-Pacific

Medtronic International Ltd.
Suite 1602 16/F, Manulife Plaza,
The Lee Gardens, 33 Hysan Avenue,
Causeway Bay,
Hong Kong
Tel. [phone]
Fax [phone]

Contacts for specific countries are listed inside this cover.

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