Nuvectra 24082412 User Manual

Algovita

™

Spinal Cord
Stimulation
System

Stimulator Models
2408 and 2412

For IPG
replacement

Implant Manual

for Stimulator

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Algovita™ is a trademark of QIG Group, LLC

CoreGuard™ is a trademark of Greatbatch, Inc.

Refer to the Information for Prescribers Manual for indications, contraindications, warnings,
precautions, adverse events, and related information.

FCC Information (US Only)

e following is communications regulation information about the Algovita Implantable Pulse
Generator (IPG).

2408 and 2412 IPG FCC ID: 2ABU824082412

ese devices comply with part 15 of the FCC Rules. Operation is subject to the following two
conditions: (1) ese devices may not cause harmful interference, and (2) ese devices must
accept any interference received including interference that may cause undesired operation.

Important: Changes and modications to these products not authorized by Algostim, LLC could
void the FCC certication and negate your authority to operate these products.

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Contents

Explanation of Symbols Used on Packaging 5

Component Description 7

Package Contents 8

Component Sterilization 8

About this IPG Replacement Manual 8

Implant Procedure 8

Preparing for Surgery 8

Preoperative IPG Preparation 9

Explanting the IPG 13

Connecting the Leads or Extensions to the New IPG 13

Checking System Integrity 16

Implanting the New IPG 16

Completing the Implant Procedure 17

Patient Counseling Information 17

SCS System Implant: IPG Replacement 17

Registration Form and Temporary Patient ID Card 18

Returning Explanted Components 18

Algostim Customer Service 18

Specications 19

Wireless Information 20

Algovita SCS System Component Compatibility 21

Algovita Spinal Cord Stimulation System

Stimulator Model 2408 and 2412 Implant Manual

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3

4 Stimulator Model 2408 and 2412 Implant Manual

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Algovita Spinal Cord Stimulation System

Explanation of Symbols Used on Packaging

Symbol Explanation

20XX

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

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

Consult instructions for use

Caution

Serial number

Catalog number

Model number

Authorized representative in Europe

Use by date

Distributed by

Manufacturer

Temperature limit

Keep dry

Sterilized using ethylene oxide

Do not resterilize

Do not reuse

Implant Manual for Stimulator

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5

Explanation of Symbols Used on Packaging

Symbol Explanation

Keep away from sunlight

Do not use if package is damaged

Phone

Recycle

Contents

IPG: 3 connector ports with 8 channels each

IPG: 2 connector ports with 12 channels each

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Algovita Spinal Cord Stimulation System

1
2

1
2
3

,LLC

,LLC

Component Description

e Algovita™ Stimulator Model 2408 or 2412 (Figure 1) is part of the Algovita Spinal Cord
Stimulation (SCS) System, a rechargeable, 24-electrode, SCS system for the treatment of chronic
pain.

Figure 1. Algovita Stimulator Model 2408 and Model 2412

e Algovita Stimulator is the implantable pulse generator (IPG) for the Algovita SCS System. In
addition to the IPG, the implanted components of the SCS system consist of percutaneous leads or
paddle leads with optional extensions.

During the intraoperative test, an external pulse generator (EPG) is used in place of the IPG. e
clinician programs the IPG and the EPG using a Clinician Programmer. e patient adjusts the
system using either of 2 patient programmers.

Algovita IPGs are 24-channel rechargeable IPGs. Each channel allows the system 1 active electrode.
e channels are distributed over 2 or 3 connector ports, depending on the IPG model.

• Algovita Stimulator Model 2408 (3x8 channel)—ree connector ports accommodate 1 to 3
percutaneous leads, with each lead allowing up to 8 active electrodes.

• Algovita Stimulator Model 2412 (2x12 channel)—Two connector ports accommodate 1 or 2
percutaneous or paddle leads, with each lead allowing up to 12 active electrodes.

e IPG delivers stimulation using independent current distribution, a technology that allows
variable amounts of current to be delivered to each active electrode.

e IPG battery is a deep discharge recovery battery with CoreGuard™ technology. Even if the
patient allows the battery to completely discharge, the battery can be recharged with the Algovita
Programmer Charger.

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Implant Manual for Stimulator

7

Package Contents

Package Contents

• Stimulator Model 2408 (3x8) or Model 2412 (2x12)

• Torque wrench

• Port plugs (3 for Model 2408, 2 for Model 2412)

• Product literature

• Temporary patient ID card

• Implant registration form and business reply envelope

Component Sterilization

e implantable and surgical accessory components were sterilized with ethylene oxide prior to
shipment. e SCS system sterile components are intended for single use only and must not be
resterilized.

Caution: Do not resterilize a system component or reimplant an explanted system component
because of risk of infection or malfunction.

About this IPG Replacement Manual

is manual provides the instructions for the replacement of an Algovita Stimulator Model 2408
or 2412. For complete instructions on implanting an IPG as part of a system implant, refer to the
system manual packaged in the lead kit.

Implant Procedure

Implanting clinicians should be thoroughly familiar with this manual and all other product
labeling.

Caution: Do not place the charging paddle on an unhealed wound. e charging paddle is not
sterile. Contact with an unhealed wound may result in an infection.

Preparing for Surgery

Before opening the sterile pack, verify the following on the sterile pack label:

• IPG—Model number and use-by date

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