Axium Clinical Programmer Manual do utilizador - Página 3

Procurar online ou descarregar pdf Manual do utilizador para Equipamento médico Axium Clinical Programmer. Axium Clinical Programmer 16 páginas.

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Explanation of Symbols on Product or Package Labeling

Model Number

Serial Number

Read the Manual

Consult the Manual

Contents of Package are Non-Sterile

Manufacturing Date

Manufacturer

Warning. Pay attention.

Protected against Electric Shock

Not waterproof. Applies to the Programmer when it is not in its carrying case.

Limited waterproof. Applies to the TNS.

Applies to the Programmer in its carrying case.

Turns the Programmer ON and OFF.

Turns stimulation OFF on the TNS.

Keep Dry

Store between -10°C and 50°C (14°F and 122°F)

Store between 0 and 93% humidity

The device is a radio transmitter

Magnet. Shows the location of the Programmer magnet.

Authorized European Representative

Introduction

The Clinical Programmer is part of the Spinal Modulation Axium Neurostimulator System. It is intended

to be used by the clinical investigator or a Spinal Modulation representative to query and program the

Neurostimulator (NS), to retrieve data from the NS and to allow for adjustment of the patient's therapy.

This User Manual gives detailed instructions on how to use the Clinical Programmer safely, how to

recharge it and how to use it to set up the patient's pain management therapy.

Indications for Use

The Spinal Modulation Neurostimulator System is indicated for the management of chronic intractable

pain.

Description

Patients who are indicated for the Axium Implantable Neurostimulator System (INS) system will first

undergo a trial period using an external Trial Neurostimulator System (TNS) connected to leads placed

within the epidural space near the dorsal root ganglion (DRG). Up to four leads may be placed and

connected to the Neurostimulator.

Although the leads and stimulator hardware used differ, the programmer hardware and instructions for

programming the TNS and INS devices are the same.

NOTE: In this manual the general abbreviation "NS" is used for information which applies to both

TNS and INS. In all other cases the specific abbreviations "TNS" or "INS" are used.

For specific description of the TNS and INS system components and implant procedures, refer to the

relevant labeling.

Two programmers are available to interact with the NS device.

1. The Clinical Programmer described in this user manual is used to program the stimulation

parameters for the NS, as determined by the physician. The NS delivers the programmed

stimulation parameters (energy) to the implanted Leads.

2. The Patient Programmer allows the patient to adjust the stimulation settings of the NS devices

within limits preset by the physician. The Patient Programmer also allows the patient to turn

stimulation off, if necessary. For further information and instructions related to the patient

programmer, refer to the respective user manual.

Warnings

The Warnings listed below pertain to the Clinical Programmer only:

• The physician must be trained by Spinal Modulation personnel before using the Clinical Programmer.

The Clinical Programmer must be used and maintained in accordance with the information in this

manual.

• Do not use the Clinical Programmer with a NS device that appears to be faulty or fails to properly

communicate.

• Improper use of the Clinical Programmer may cause irreversible injury to the patient. All patients are

to be awake and conversant during the procedure to minimize the likelihood of any nerve damage

• Always set the NS device amplitude to 0 µA when repositioning a lead or attaching the Connector

Cable to the external TNS. When restarting stimulation, increase the NS amplitude slowly until the

desired paresthesia is achieved.