St. Jude Medical 2304, 2305 Users guide

SN

EC REP

IS-1 Pocket Adapter

manuals.sjm.com

Models: 2304 (25cm) and 2305 (50cm)

Description/Intended Use

The IS-1 Pocket Adapter is designed to
adapt a Medtronic™ extension (series
7471, 7472, 7482, 7489, 7495, 7496
and 7498) to a St.Jude Medical™
neurostimulator. (Medtronic is a trademark
of Medtronic,Inc.)

Each Kit Contains

• 1 each Pocket Adapter

• 1 each Torque Wrench
Connector strength of the IS-1 Pocket
Adapter exceeds 10N, the Model 2304
adapter has a maximum resistance of

2.65ohms, and the Model 2305 adapter
has a maximum resistance of 5.30ohms.

The IS-1 Pocket Adapter contains silicone
and bionate materials that come into contact
with tissue. Patients who are allergic should
not be implanted.

See the appropriate St.Jude Medical
clinician’s manual and Medtronic manual
before use for additional warnings and
precautions related to those devices.

Symbols And Their Meanings

The following symbols may be used in this
document and on some of the products and
packaging:

Symbol Definition

Caution, consult accompanying
documents

Consult instructions for use

Follow instructions for use on this
website

Symbol Definition

Do not resterilize

Expiration date

Date of manufacture

Manufacturing facility

Temperature limits for storage
conditions

Humidity limits

Pressure limits

Do not use if the product
sterilization barrier or its packaging
is compromised

Catalog number

Manufacturer

Contents quantity

Accessories

Serial number

Batch code

Prescription use only

Ethylene oxide gas sterilization

Authorized European representative

European conformity, affixed in
accordance with the relevant
provisions of AIMD directive
90/385/EEC. Hereby, St.Jude
Medical declares that this device
is in compliance with the essential
requirements and other relevant
provisions of these directives.

Additional Symbols for Product Labels

The following table shows additional symbols
that may appear on the product labels for
parts related to this kit.

Symbol Definition

IS-1 Pocket Adapter,
25cm

IS-1 Pocket Adapter,
50cm

Torque Wrench

Directions For Use

To implant the IS-1 Pocket Adapter

1. Carefully disconnect the implanted
extension from the neurostimulator and
discard the neurostimulator.

2. Clean the contacts of the extension with
sterile de-ionized or distilled water (not
saline) and dry them completely with a
sterile gauze sponge.

3. Gently push the terminal (proximal) end
of the extension into the IS-1 Pocket
Adapter until it stops.

IS-1 Pocket Adapter Medtronic Extension

4. Confirm visually that the extension is fully
inserted into the IS-1 Pocket Adapter. The
extension header should be flush with the
IS-1 Pocket Adapter.

Single use only

Unless otherwise noted, ™ indicates that the name is

EC REP

a trademark of, or licensed to, St.Jude Medical or one
of its subsidiaries. ST.JUDE MEDICAL and the nine­squares symbol are trademarks and service marks of
St.Jude Medical, LLC and its related companies.

Pat. http://patents.sjm.com

© 2020 St.Jude Medical, LLC. All Rights Reserved.

St.Jude Medic al
6901 Preston Road
Plano, Texas 75024
USA
[phone]

St. Jude Medic al
Coordination Center BVBA
The Corpo rate Village
Da VinciIaan 11 Box F1
1935 Zaventem
Belgium
[phone]

St. Jude Medic al Puerto Rico LLC
Lot A Interior - # 2 Rd Km. 67.5
Santana Indus trial Park
Arecibo, PR 0 0612
USA

St. Jude Medic al Operations (M) S dn. Bhd.
Plot 102, Lebuhraya K ampung Jawa,
Bayan Lepas Industrial Zone
11900 Penang
Malaysia

sjm.com

2020-01
ARTEN600119097 A

*600119097*

5. Secure the extension by tightening the
two screws in the IS-1 Pocket Adapter
with the torque wrench provided. Tighten
the screws until you hear a click.

6. Follow the instructions in the
St.Jude Medical Clinician’s Manual for
implantation of the neurostimulator.

One-Year Warranty

From the date of implant of the IS-1 Pocket
Adapter, St.Jude Medical will extend our
standard Limited Warranty* to include a
one-year Limited Warranty on previously
implanted leads and extensions when
they are properly connected to a St.Jude
Medical™ IS-1 Pocket Adapter and
neurostimulator.

This warranty provides for the replacement
of the previously implanted leads and/or

extensions with St.Jude Medical leads
and/or extensions if the previously implanted
product is in good operating condition at
the time of connection to the IS-1 Pocket
Adapter.

* The terms of the standard St.Jude

Medical Limited Warranty are described in
St.Jude Medical Clinician’s Manuals.

Customer Service Information

For help with a St.Jude Medical™
neuromodulation product, including
technical service or repairs, contact
Customer Service using the following
information:

St.Jude Medical

6901 Preston Road
Plano, TX 75024
USA
[phone] (toll-free
within North America)
[phone]

EC REP

St.Jude Medical

Coordination Center BVBA

The Corporate Village
Da Vincilaan 11 Box F1
1935 Zaventem
Belgium
[phone]

CE Mark Date

The following table lists the year in which
the CE mark was awarded by model number.

Model Year

1101 1999

2304, 2305 2009