Boston Scientific SC-4108 Manual

Clinician Trial Manual
92089828-02
Content: 92223764 REV A
Directions for Use
Instrucciones de uso
Mode d’emploi
Gebrauchsanweisung
Istruzioni per l’uso
Gebruiksaanwijzing
Bruksanvisning
Käyttöohje
Bruksanvisning
Brugsanvisning
Instruções de Utilização
Instruções de uso
Kullanım Talimatları
Указания по использованию
ماﺪﺨﺘﺳﻻا تادﺎﺷرإ
Οδηγίες χρήσης
Návod k použití
Návod na použitie
Instrukcja obsługi
Használati utasítások
en es fr de it nl sv no da pt ptBR tr ru ar el cz sk pl hu

Clinician Trial Manual
Clinician Trial Manual
92089828-02 ii of iv
en
Trademarks
All trademarks are the property of their respective owners.
Guarantees
Boston Scientic Corporation reserves the right to modify, without prior notice, information
relating to its products in order to improve their reliability or operating capacity.
Drawings are for illustration purposes only.
Additional Information
For Indications and related information, see the Indications DFU. For contraindications,
warnings, precautions, adverse events summary, physician instructions, sterilization, storage
and handling, component disposal, and contact information for Boston Scientic, refer to the
Information for Prescribers DFU for your spinal cord stimulator system. For other device-
specic information not included in this manual, labeling symbols, and warranty information,
refer to the appropriate DFU for your SCS System as listed on your Reference Guide.
Product Model Numbers
Model Number Description
SC-4108 OR Cable 2x8, 213 cm and Extension
SC-4116 OR Cable 1x16, 213 cm and Extension
SC-5132 Trial Stimulator
SC-5160 Trial Stimulator
SC-6360-32 Patient Trial Belt

Clinician Trial Manual
92089828-02 iii of iv
en
Table of Contents
OR Cable Description.....................................................................................1
Package Contents ..........................................................................................2
Instructions for Use........................................................................................2
Insert the Leads into the OR Cable Connector...................................................................3
ETS Description..................................................................................................................4
Connect to the ETS ............................................................................................................5
Fitting the Trial Belt to the Patient.......................................................................................6
Replacing the External Trial Stimulator Battery ..................................................................6
Telemetry Symbol for Optimal Device Orientation......................................7

Clinician Trial Manual
Clinician Trial Manual
92089828-02 iv of iv
en
This page intentionally left blank.

OR Cable Description
Clinician Trial Manual
92089828-02 1 of 197
en
OR Cable Description
CAUTION: Do not immerse the OR Cable or extension in water or other liquids. The OR
Cable and extension are intended for one-time only use; do not resterilize.
The OR Cable is designed for two purposes:
• Connect the Lead to the External Trial Stimulator (ETS), see “ETS Description” on page
4, to facilitate intraoperative stimulation testing from outside of the sterile eld.
• Connect the Lead to the ETS during the trial phase.
The 2x8 OR Cable connects to (2) 8-contact Leads. (When referring to the use of the OR
Cable, a Lead refers to the proximal end of a Lead, splitter, or extension.) The 2x8 OR Cable is
compatible with any Boston Scientic Lead with an 8-contact proximal end.
BA C D
Figure 1: 2x8 OR Cable
The 1x16 OR Cable connects to a 1x16 contact Lead.
16
Figure 2: 1x16 OR Cable
The OR Cable extension may be used when desired to connect the OR Cable to the ETS.
Figure 3: OR Cable Extension

Clinician Trial Manual
Clinician Trial Manual
92089828-02 2 of 197
en
Package Contents
OR Cable Kit (2x8)
(1) OR Cable (2x8)
(1) Extension
(1) Manual
OR Cable Kit (1x16)
(1) OR Cable (1x16)
(1) Extension
(1) Manual
Instructions for Use
Boston Scientic recommends that implanting physicians read all product labeling prior to using
our devices.
After the Trial, an applicable Boston Scientic SCS system may be used in the permanent
implantation procedure:
• Precision Spectra™ SCS System
• Precision Novi™ SCS System
• Precision Montage™ MRI SCS System
• Spectra WaveWriter™ SCS System
CAUTION: Always turn the ETS off and decrease the strength of stimulation to zero before
connecting or disconnecting the OR Cable or extension.
1. Verify that the ETS is off.
2. Check that the locking lever on the OR Cable connector is in the open position, marked with
the unlocked symbol.
16
Locking Lever in
the open position
Locking Lever in
the open position

Instructions for Use
Clinician Trial Manual
92089828-02 3 of 197
en
3. If necessary, wipe uids from the proximal ends of the Leads.
4. Insert the Leads into the OR Cable Connector. See instructions on page 3.
Insert the Leads into the OR Cable Connector
You can insert the Leads into the OR Cable Connector with the steering cap on or off.
1. To insert the Lead with the steering cap
on:
a. Pull the stylet out slightly.
Steering Cap Stylet Lead
Steering Cap Stylet Lead
b. Slide the stylet through the side
slot in the OR Cable connector.
BA C D
Slide
Slide
1. To insert the Lead with the steering cap
off, remove the steering cap from the
stylet.
2. Insert the Lead into the port of the OR Cable connector until it stops.

Clinician Trial Manual
Clinician Trial Manual
92089828-02 4 of 197
en
BA C D
Slide
BA C D
Slide
Insert Insert
3. While continuing to hold the Lead in place, slide the lever to the locked position.
BA C D
Hold
Slide
Hold
Slide
4. Repeat this for additional Leads (if applicable).
Note: Once the Lead is secured in the connector, the stylet can be rotated in, but not removed
from the Lead.
5. Connect to the ETS. Refer to instructions on page 5.
6. For Intraoperative Testing instructions, proceed to the instructions for Intraoperative Testing
in the appropriate Leads manual.
ETS Description
The ETS is a temporary external spinal cord stimulator that is connected via the OR cable(s)
to the Lead(s) placed along the spinal cord. This external system is used to test how effective
stimulation is in relieving a patient’s pain.

Instructions for Use
Clinician Trial Manual
92089828-02 5 of 197
en
CAUTION:
• Keep the External Trial Stimulator dry. It should not be exposed to moisture.
• Do not connect the External Trial Stimulator to any other device except to the OR Cables
provided with it.
• Keep the External Trial Stimulator away from pets, pests, and children to avoid damage to
the device.
Connect to the ETS
1. Plug the OR Cable or extension into the desired ETS port(s).
2. Note connections from Lead to OR Cable to ETS to facilitate testing and programming. See
the example below. Note: Stickers may be used to label OR Cables.
AB
16
ABCD
AB
CD
16
ABCD
CD
BA C D
ABCD
A B
BA C D
ABCD
C D

Clinician Trial Manual
Clinician Trial Manual
92089828-02 6 of 197
en
3. Refer to “Securing the Trial Lead” in the appropriate Leads Directions for Use.
If desired, secure the OR Cable to the skin using standard dressing technique.
• OR Cables may be placed side by side and gauze may be used as padding. The area may
be covered with an adhesive and secured with a bandage or dressing.
Fitting the Trial Belt to the Patient
1. Determine which side of the patient is best for placement of the ETS.
2. Fit the trial belt to the patient with the pocket opening facing the patient’s back.
3. Fasten the belt to the patient.
4. If desired, cut off excess length of the trial belt.
5. Place the ETS in the belt pocket with the stimulation ON/OFF button facing up.
6. If OR Cable extension(s) were used, ensure that they are no longer connected to the OR
Cable(s).
7. Connect the OR Cable(s) to the ETS.
8. Fasten the belt pocket to secure the ETS.
BA C D
1
2
5
34
1 – OR Cable
2 – OR Cable Connection to ETS
3 – ETS
4 – Trial Belt
5 – Lead or Extension
Replacing the External Trial Stimulator Battery
1. Be sure that stimulation is off (the indicator light is not blinking)
before opening the ETS battery compartment.
2. On the rear of the ETS, push in slightly and slide down the bat-
tery compartment cover.
ABCD
Slide
Insert
Batteries
Insert
Batteries
Slide