Boston Scientific SC-4116 User manual

90970871-06 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
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Οδηγίες χρήσης
Návod k použití
Návod na použitie
Instrukcja obsługi
Használati utasítások
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Clinician Trial
Manual

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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-6360-32 Patient Trial Belt

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Table of Contents
OR Cable Description.....................................................................................1
Package Contents ..........................................................................................2
Instructions for Use........................................................................................2
Insert the Leads into the OR Cable Connector...................................................................3
Trial Stimulator Description.................................................................................................4
Connect to the Trial Stimulator ...........................................................................................5
Fitting the Trial Belt to the Patient.......................................................................................6
Replacing the Trial Stimulator Battery ................................................................................6
Telemetry Symbol for Optimal Device Orientation......................................7

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OR Cable Description
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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 Trial Stimulator (see: “Trial Stimulator Description” on page 4) to
facilitate intraoperative stimulation testing from outside of the sterile eld.
• Connect the lead to the Trial Stimulator 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 Trial
Stimulator.
Figure 3: OR Cable Extension

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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 trialing with the Precision Spectra™ SCS System, 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
CAUTION: Always turn the Trial Stimulator off and decrease the strength of stimulation to
zero before connecting or disconnecting the OR Cable or extension.
1. Verify that the Trial Stimulator is off.
2. Check that the locking lever on the OR Cable connector is in the open position, marked with
the unlocked symbol.
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Locking Lever in
the open position
Locking Lever in
the open position

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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.
BA C D
Slide
BA C D
Slide
Insert Insert

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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 Trial Stimulator. Refer to instructions on page 5.
6. For Intraoperative Testing instructions, proceed to the instructions for Intraoperative Testing
in the appropriate Leads manual.
Trial Stimulator Description
The Trial Stimulator 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.

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Connect to the Trial Stimulator
1. Plug the OR Cable or extension into the desired Trial Stimulator port(s).
2. Note connections from lead to OR Cable to Trial Stimulator 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
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.

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Fitting the Trial Belt to the Patient
1. Determine which side of the patient is best for placement of the Trial Stimulator.
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 Trial Stimulator 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 Trial Stimulator.
8. Fasten the belt pocket to secure the Trial Stimulator.
BA C D
1
2
5
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1– OR Cable
2 – OR Cable Connection to Trial Stimulator
3 – Trial Stimulator
4 – Trial Belt
5 – Lead or Extension
Replacing the Trial Stimulator Battery
1. On the rear of the Trial Stimulator, push in slightly and slide
down the battery compartment cover.
2. Place the two new AA batteries in the slots, matching the
positive (+) and (-) markings in the compartment.
3. Align the battery compartment cover on the case and slide the
cover into position until it snaps closed.
ABCD
Slide
Insert
Batteries
Insert
Batteries
Slide