Manual

ManualsBrandsBoston Scientific Neuromodulation ManualsElectronicsPrecision SCS System External Trial Stimulator

Physician Trial Kit

Part No. MP9055214 Rev. A

Physician Trial Kit Model SC-7005-02

Trial Stimulator Model SC-5110

Remote Control Model SC-5210

CAUTION:

Federal law restricts this device to sale, distribution

and use by or on the order of a physician.

The Advanced Bionics® Trial Stimulator is intended

to be used during a screening trial to assess the

efficacy of spinal cord stimulation in the treatment of

patients with chronic pain of the trunk or limbs. The

Trial Stimulator communicates with, and is

controlled by, both a patient programmer (the

Remote Control) and a clinician programmer via a

wireless link.

The Remote Control unit is a hand-held device for

patient control of both the external Trial Stimulator

and the permanent, implantable pulse generator

(IPG) models of the Precision™ SCS device.

Following set up of the Remote Control by the

clinician, the Trial Stimulator is able to respond to

patient control of:

• stimulation on/off functions

• stimulation amplitude and other (optional)

parameters

• stimulation delivery areas

• individualized stimulation therapy programs.

Patient use instructions are outlined in the Patient

Trial Handbook.

CAUTION:

• To avoid unexpected stimulation results, never

make connections while the Trial Stimulator is

on.

• The battery used in the Trial Stimulator may

present a risk of fire or chemical burn if mis-

treated. Do not disassemble, heat above 100ºC

(212ºF), or incinerate.

• Handle the devices with care. Although dura-

bility testing has been performed to ensure

quality manufacturing and performance, drop-

ping the devices on hard surfaces or in water,

or other destructive handling, can cause per-

manent damage.

• Avoid all sources of water that can come into

contact with the devices.

• Do not expose the devices to extreme tempera-

tures. Store between 5 – 40 ºC (41 – 104 ºF).

• Do not dispose of the devices in fire.

Trial Stimulator

General Instructions

1. Ensure that the Trial Stimulator is equipped with

a new 6-volt battery before conducting intraop-

erative stimulation testing, and for each new

trial. (A battery is included in the Patient Trial

Kit.)

2. Before connecting the OR Cable for intraopera-

tive testing, ensure that the Trial Stimulator is

off (no indicator light). Turn the stimulator on

for testing, then return it to off before discon-

necting the test cables.

3. When fitting the patient with the Trial Stimula-

tor, ensure that the OR Cables are properly con-

nected and labelled. Superior (upper or left)

leads connect to socket 1-L. Inferior (lower or

right) leads connect to socket 2-R. If only a sin-

gle lead is being used, connect it to 1-L.

4. Before releasing the patient, ensure that he/she

understands:

• Basic control of the Trial Stimulator using the

Remote Control, and that stimulation may be

turned on and off with the E button on either

unit.

• How to disconnect and reconnect the OR

Cable(s)

with the power off.

• How to replace the Trial Stimulator battery.

(See illustration below)

NOTE: Immediately following a Trial Stimulator

battery replacement, the linked Remote Control

will display an error/reset message. Press D to

reset the stimulator .

Remote Control

Battery Information

The Remote Control uses three AAA batteries. The

device will issue warnings when its batteries are low

and when the Trial Stimulator battery needs

replacement. Instruct patients to pay close attention

to all battery messages.

NOTE: The first time it comes on following a

battery replacement, the Remote Control will

reload information from the implanted or exter-

nal stimulator. The remote must be within com-

munication range (two feet) of the stimulator

during this period.

Battery Replacement

1. On the rear of the remote, push in slightly and

slide the battery compartment cover down.

2. Remove the old batteries.

3. Place the new batteries in the slots by matching

the positive (+) and negative (-) battery ends

with the + / - markings in the compartment.

4. Align the cover on the case and slide the cover

into position util it snaps closed.

DRAFT

Summary of content (2 pages)

PAGE 1
Patient use instructions are outlined in the Patient Trial Handbook. • stimulation on/off functions • stimulation amplitude and other (optional) parameters • stimulation delivery areas • individualized stimulation therapy programs.
PAGE 2
3. To change the stimulation level of just one area: a) From the level screen, press Cas many times as necessary to find the desired area by name or number. b) Press S or T to make the change. General Instructions 1. To turn stimulation on or off, press the E button. If the Remote Control is in sleep/idle mode and you press any button other than E, the remote will display a “Keys Locked” message. You must press Dto unlock the “function” buttons when reactivating the Remote Control from sleep mode. 2.