Boston Scientific Neuromodulation PSC5210W Precision SCS System Remote Control User Manual II Physicans Implant

Boston Scientific Neuromodulation Corporation Precision SCS System Remote Control II Physicans Implant

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Physician Implant Manual

CAUTION:

Federal law restricts this device to sale, distribution and use by or on

the order of a physician.

MP9055182 Rev A

DRAFT

Physician Implant Manual

copying, reproduction or translation of all or part of the contents of

this document without the express written permission of Advanced

Bionics Corporation is strictly forbidden by the provisions of the law

of March 11th, 1957.

Guarantees

Advanced Bionics Corporation reserves the right to modify, without

prior notice, information relating to its products in order to improve

their reliability or operating capacity.

Registered Trademarks

BionicNavigator™ and Precision™ are registered trademarks of

Advanced Bionics Corporation. Velcro® is a registered mark of Velcro

Industries, Manchester, New Hampshire. Other brands and their prod-

ucts are trademarks or registered trademarks of their respective hold-

ers and should be noted as such.

Table of Contents

iii

Table of Contents

Introduction ............................................... 1

Manual Overview ........................................................... 1

Device Description .......................................................... 1

Features ........................................................................1

Indications for Use ...........................................................2

Precision System Clinical Summary .....................................2

Efficacy Evaluation .................................................... 2

Safety Evaluation .......................................................5

............................................................................. 6

Clinical Experience-Safety ...........................................6

References ............................................................... 7

Contraindications ............................................................8

Safety Information ..................................... 9

Warnings ......................................................................9

Precautions .................................................................. 10

Adverse Effects ............................................................. 11

Instructions for the Physician .............................................13

Sterilization ..................................................................13

Handling .....................................................................15

Storage .......................................................................15

Package Contents .................................... 16

Patient Identification ................................ 17

Guidelines for Permanent Implantation .... 18

Percutaneous Lead/Extension Removal ..............................18

Option A. Temporary Lead Removal ...........................18

Option B. Extension Removal .....................................18

Physician Implant Manual

IPG Implantation ........................................................... 20

Tool Assembly .............................................................. 21

Tunneling The Lead ........................................................ 21

Connecting To the IPG ...................................................25

Dual Lead Connection .............................................. 25

Single Lead Connection ............................................25

IPG Explant or Replacement ..................... 28

Rechargable Implant System .................... 29

IPG Battery Status .......................................................... 29

Charging Steps ............................................................ 30

Patient Remote Control ............................. 34

Basic Operation ........................................................... 34

Stimulation On/Off ................................................. 35

Stimulation Amplitude ...............................................35

Coverage Area Selection ..........................................36

Program Selection ................................................... 36

Modifying and Saving Programs ................................36

Options ................................................................. 38

Device Linking ..............................................................39

Clinician Options ..........................................................42

To Clear Link .......................................................... 43

For CP Mode ......................................................... 44

For Impedances ...................................................... 45

Programmer Communication ...........................................47

Specifications and Technical Data ............. 48

.................................................................................48

Materials .....................................................................48

Table of Contents

Maximum Current Amplitude per Electrode

versus Impedance .................................... 49

Registration Information .......................... 50

Registering the Implant ...................................................50

Technical Service ...................................... 51

Limited Warranty ..................................... 52

Physician Implant Manual

Introduction

Manual Overview

This manual provides basic information for the implantation and

operation of the Precision™ Implantable Pulse Generator (IPG),

Model SC-1110. This information includes an overview of accesso-

ries for programming and powering the IPG, clinical and surgical con-

siderations, storage and handling requirements, and relevant

precautions concerning an implanted neurostimulator. Additional

information on system components and operation can be found in the

BionicNavigator™ Software Guide.

Device Description

The Advanced Bionics® Precision implantable pulse generator system

is intended to treat chronic pain by electrically stimulating the spinal

cord. The multi-channel, multi-electrode device capability provides

flexibility in conjunction with ease of programming. A rechargeable

battery increases IPG longevity and output capability while reducing

size and device replacement surgeries. The implant is controlled by a

handheld Remote Control, and can be engaged by a clinician com-

puter using proprietary BionicNavigator software. Periodically, the

implant battery requires replenishing with an RF charging device pro-

vided in the Patient Take Home Kit SC-6000-02.

Features

• Stimulation electrode field navigation

• Sixteen independent current-controlled electrodes

• Four programmable stimulation areas per program; four

possible programs

• Long-life operation

• High-range parameter capability

•Small size

• Two-foot programming range

Physician Implant Manual

Indications for Use

The Advanced Bionics PRECISION™ Spinal Cord Stimulator System

(PRECISION™ System) is indicated as an aid in the management of

chronic intractable pain of the trunk and/or limbs, including unilateral

or bilateral pain associated with the following: failed back surgery

syndrome, intractable low back pain and leg pain.

Precision System Clinical Summary

Determination of the safety and effectiveness of the PRECISION Sys-

tem was based on available published clinical studies for similar

implanted spinal cord stimulation systems. The PRECISION System

is similar to the SCS systems reported in published literature in

intended use, target patient population, technology, device design, and

output characteristics. Therefore, the clinical data from the published

literature described below represents evidence supporting the safety

and effectiveness of the PRECISION System for the treatment

chronic intractable pain of the trunk and/or limbs, including unilateral

or bilateral pain associated with the following: failed back surgery

syndrome, intractable low back and leg pain.

Efficacy Evaluation

Three (3) clinical literature studies were used to support the effective-

ness of the PRECISION System (Ohnmeiss et al. 1996, Villavincen-

cio et al. 2000, Hassenbach SJ et al. 1995). The studies included a

total of 116 patients that were implanted with an SCS system. A total

of approximately 3166 device months of experience was depicted

from the retrospective clinical evaluation. All three studies examined

the effectiveness of SCS on patients with chronic pain of the trunk

and/or limbs including unilateral or bilateral pain associated with the

following: failed back surgery syndrome or intractable low back and

leg pain. In all studies, a totally implantable spinal cord stimulator

was used in association with a percutaneous and/or surgical lead.

These studies provide the same diagnostic or therapeutic intervention

Introduction

for the same disease/conditions and patient population as the PRECI-

SION System.

The prospective study by Ohnmeiss et al. 1996, examined the long-

term effectiveness of SCS in patients with intractable leg pain. Forty

patients were implanted with SCS systems and evaluated at 6 weeks,

12 months, and 24 months follow-up. Outcome measures included the

VAS, pain drawings, medication use, SIP (Sickness Impact Profile),

isometric lower extremity testing, and patient questionnaires. An

intent-to-treat analysis was performed. After patients had SCS for 24

months, leg pain, pain when walking, standing pain, pain’s effect on

overall lifestyle, and the total analog scale scores were significantly

improved from baseline. In this study, 25% of the implanted patients

had greater than 50% improvement in pain rating.

In addition, 3 patients from this study had their stimulators reposi-

tioned due to pain at the original location. Three patients had reopera-

tions to adjust lead position; 1 patient required 2 reoperations, 1

patient had the device removed due to infection and later to have a

new device implanted. A diabetic patient had skin problems which

required device removal; a new device was later implanted. Two

patients had the device removed due to unsatisfactory pain relief.

The prospective study performed by Villavicencio et al. 2000

included 41 patients with pain of various etiologies. The majority of

the patients, 24 (59%), had Failed Back Surgery Syndrome (FBSS), 7

(17%) had Complex Regional Pain Syndrome (CRPS I and II), 4

(10%) had neuropathic pain syndrome, and 6 (15%) were diagnosed

as stroke or other. Patients underwent an initial trial period for SCS

with temporary leads. If the trial resulted in greater than 50% reduc-

tion in the patient’s pain, as measured by the VAS, the patient was

implanted with a SCS system. In this study, 27/41 patients, 66%, had

permanent implants. All patients were examined after 6 weeks. Pain

measurements were assessed at 3-6 month intervals for the first year

and annually thereafter. The median long-term follow-up was 34

months. A total of 24/27 (89%), reported greater than 50% reduction

Physician Implant Manual

in pain. Since the majority of the patients were treated for FBSS, this

article supports the use of SCS for the treatment of FBSS.

In this study, one patient required a revision because of electrode frac-

ture. One patient required removal of the system due to local infec-

tion. One patient required replacement of the IPG due to mechanical

failure. Overall, 16 of 27 (59%) patients required a total of 36 reposi-

tioning procedures.

A retrospective analysis performed by Hassenbusch SJ et al. 1995

included patients with chronic lower body pain, predominately neuro-

pathic pain and pain either midline lower back and/or unilateral or

bilateral leg pain treated over a 5 year period. The study was a com-

parison of SCS to spinal infusion of opiods. For patients with radicu-

lar pain involving one leg with or without unilateral buttock pain, a

trial of SCS was recommended first. For patients with midline back

pain and /or bilateral leg pain, a trial of long-term spinal infusion was

recommended first. If the patients failed screening with either of these

modalities, the other was then tested. If the treatment reduced the pain

by 50%, the systems were internalized. A retrospective analysis of

patients with unilateral leg and/or buttock pain treated initially with

SCS and bilateral leg or mainly low back pain treated initially with

spinal infusions of opioids was then done.

In this study, 42 patients were screened; 26 (62%) patients received

spinal stimulation; 16 (38%) received opioids via a spinal infusion

pump. Five patients did not receive adequate pain relief with SCS; 3

(7%) of these patients underwent trial spinal infusions and had effec-

tive pain relief. There were 4 (10%) patients who underwent a trial of

spinal infusion of opioid but did not receive adequate pain relief;

these patients were not tested with SCS. Pain severity was rated using

a verbal digital pain scale: “On a scale of 0 to 10 where 0 is no pain

and 10 is the worst pain you could ever imagine, what is your pain

now?” 16/26 patients (62%) had greater than 50% pain relief with

SCS. In this study, 2/16 (13%) had greater than 50% pain relief with

Introduction

opioids. Mean follow-up was 2.1 + 0.3 years. This analysis supports

the use of SCS for intractable low back and leg pain.

In this study, 7 (17%) patients suffered complications after implanta-

tion of the device; 5 (12%) patients required repositioning of catheter

type electrodes and 2 patients required revision of the stimulator gen-

erator.

Safety Evaluation

Eleven studies were identified based on the detailed inclusion/exclu-

sion criteria to demonstrate the safety of the PRECISION System.

The studies included a total of 1056 patients that were trialed with

SCS systems and 880 patients that received implants. The table below

depicts the number of patients, the number of events, and the percent-

age of occurrences of each event compared to the total number of

patients. It should be noted that citations cover both IPG and RF Sys-

tems. The clinical experience reported in the literature on RF systems

is relevant to determining the safety of totally implantable IPG sys-

tems.

Table 1: Summary of Risks Identified in the Retrospective

Clinical Studies

Risks

# Patients

With

Adverse

Event

Intent-to-

Treat Basis

N = 1056

Implanted

Patient

Basis

N = 880

Lead Migration 175 16.6% 19.9%

Infection 39 3.7% 4.4%

Epidural Hemorrhage 0 0% 0%

Seroma 0 0% 0%

Hematoma 1 0.1% 0.1%

Paralysis 0 0% 0%

CSF Leak 5 0.5% 0.6%

Physician Implant Manual

Clinical Experience-Safety

Clinical data has been collected during a clinical study of the PRECI-

SION™ System. As of January 15, 2004, 35 subjects were enrolled in

the study at multiple sites and 26 subjects had a successful trial stimu-

lation period and were implanted with the PRECISION™ System.

The follow-up period for the 26 implanted patients ranged from 2

weeks to 6 months. The following major adverse events were

reported.

Table 2: Clinical Experience Safety

Over/Under Stimula-

tion, Ineffective Pain

Control

46 4.4% 5.2%

Intermittent Stimula-

tion

00%0%

Pain Over Implant 16 1.5% 1.8%

Allergic Reaction 6 0.6% 0.7%

Skin Erosion 0 0% 0%

Lead Breakage 35 3.3% 4.0%

Hardware Malfunction 22 2.1% 2.5%

Loose Connection 0 0% 0%

Battery Failure 2 0.2% 0.2%

Other 45 4.3% 5.1%

Type Number of Patients Resolution

Lead Migration 1 Lead repositioning

and subsequent

replacement

Output malfunction 1 Device replaced

Introduction

Other minor adverse events reported by at least one patient included:

receiver malfunction, skin irritation, unpleasant stimulation, CSF

leak, infection at implant site, lead migration, and OR cable malfunc-

tion. Two of the subjects reported multiple events.

References

Burchiel, K.J., V.C. Anderson, F.D. Brown, R.G. Fessler, W.A.

Friedman, S. Pelofsky, R.L. Weiner, J. Oakley,and D. Shatin.

“Prospective, Multicenter Study of Spinal Cord Stimulation for

Relief of Chronic Back and Extremity Pain.” Spine, 21:2786-

2793, 1996.

Hassenbusch, S.J., M. Stanton-Hicks, E.C. Covington. “Spinal cord

stimulation verses spinal infusion for low back and leg pain”.

Acta Neurochirgica, 64:109-115, 1995.

Kemler, M.A., G.A.M. Barendse, M. Van Kleef, H.C.W. De Vet,

C.P.M. Rijks, C.A. Furnee and F.A.J.M. Van den Wilderberg.

“Spinal Cord Stimulation in Patients with Chronic Reflex

Sympathetic Dystrophy.” New England J of Medicine, 343:

618-24, 2000.

Kim S. H., R.R. Tasker, and M.Y. Oh. “Spinal Cord Stimulation for

Nonspecific Limb Pain versus Neuropathic Pain and

Spontaneous versus Evoked Pain.” Neurosurgery, 48(5): 1056-

1064, 2001.

Kumar, K., C. Toth, R. Nath, and P. Lang. “Epidural Spinal Cord

Stimulation for Treatment of Chronic Pain-Some Predictors of

Success. A 15 year experience.” Surg Neurol, 50: 110-120,

1998.

Infection 1 Infection treated

Pain 1 Lead explanted

Physician Implant Manual

Lang, P. “The Treatment of Chronic Pain by Epidural Spinal Cord

Stimulation.” AXON, 18(4): 71-73, 1997.

Ohnmeiss, D., R. Rashbaum, M. Bogdanffy. Prospective Outcome

Evaluation of Spinal Cord Stimulation in Patients With

Intractable Leg Pain. Spine, 21:1344-1351, 1996.

Rainov, N.G., V. Heidecke, and W. Burkert. “Short Test-Period Spinal

Cord Stimulation for Failed Back Surgery Syndrome.” Minim

Invasive Neurosurg, 39(2):41-44, 1996.

Segal, R., B. Stacey, T. Rudy, S. Basser, J. Markham. “Spinal Cord

Stimulation Revisited.” Neurological Research, 20:391-396,

1998.

Spieglemann, R. and W.A. Friedman. “Spinal Cord Stimulation: A

Contemporary Series.” Neurosurg 28:65-71, 1991.

Villavicencio, A.T., J.C. Leveque, L. Rubin, K. Bulsara, and J.P.

Gorecki. “Laminectomy versus percutaneous electrode

placement for spinal cord stimulation.” Neurosurgery, 46:399-

406, 2000.

Contraindications

Patients contraindicated for permanent SCS therapy are those who:

• are unable to operate the SCS system

• have failed trial stimulation by failing to receive effec-

tive pain relief

• are poor surgical risks

• are pregnant

Safety Information

Warnings

Magnetic Resonance Imaging (MRI). Patients implanted with the

Precision SCS system should not be subjected to MRI. MRI exposure

may result in dislodgement of implanted components, heating of the

neurostimulator, damage to the device electronics and/or voltage

induction through the leads and stimulator causing an uncomfortable

or “jolting” sensation.

Pediatric Use. The safety and effectiveness of spinal cord stimula-

tion has not been established for pediatric use.

Diathermy. Shortwave, microwave and/or therapeutic ultrasound

diathermy should not be used on SCS patients. The energy generated

by diathermy can be transferred through the stimulator system, caus-

ing tissue damage at the lead site and resulting in severe injury or

death. The IPG, whether it is turned on or off, may be damaged.

Implanted Stimulation Devices. Spinal cord stimulators may

interfere with the operation of implanted sensing stimulators such as

pacemakers or cardioverter defibrillators. The effects of implanted

stimulation devices on neurostimulators is unknown.

Implant Damage. Burns may result if the pulse generator case is

ruptured or pierced and patient tissue is exposed to battery chemicals.

Do not implant the device if the case is damaged.

Postural Changes. Patients should be advised that changes in pos-

ture or abrupt movements may cause decreases, or uncomfortable or

painful increases in the perceived stimulation level. Patients should

be advised to turn down the amplitude or turn off the IPG before mak-

ing posture changes. If unpleasant sensations occur, the IPG should be

turned off immediately.

Physician Implant Manual

Electromagnetic Interference. Strong electromagnetic fields can

potentially turn the stimulator off, or cause uncomfortable or jolting

stimulation. Patients should be counseled to avoid or exercise care

around:

• Theft detectors or security screeners such as those used

at entrances/exits of department stores, libraries, and

other public establishments, and/or airport security

screening devices. It is recommended that patients

request assistance to bypass the device. If they must pro-

ceed through the device, the patient should turn off the

stimulator and proceed with caution, ensuring to move

through the center of the screener as quickly as possible.

• Power lines or power generators

• Electric steel furnaces and arc welders

• Large, magnetized stereo speakers

Precautions

Physician training is required.

Medical Devices/Therapies. The following medical therapies or

procedures may turn stimulation off or may cause permanent damage

to the implant, particularly if used in close proximity to the device:

• lithotripsy

• electrocautery: Do not use monopolar cautery.

• external defibrillation

• radiation therapy

• ultrasonic scanning

• high-output ultrasound

If any of the above is required by medical necessity, refer to “Instruc-

tions for the Physician” on page 15. Ultimately, however, the device

may require explantation as a result of damage to the device.

Safety Information

Automobiles and Other Equipment. Patients should not operate

automobiles, other motorized vehicles, or potentially dangerous

machinery/equipment with therapeutic stimulation switched on. Stim-

ulation must be turned off first. Sudden stimulation changes, if they

occur, may distract patients from attentive operation of the vehicle or

equipment.

Cell Phones. While we don’t anticipate any interference with cell

phones, the full effects of interaction with cell phones are unknown at

this time.

Post Operative. During the two weeks following surgery, it is

important to use extreme care so that appropriate healing will secure

the implanted components and close the surgical incisions: Do not

exercise or attempt to move heavy objects, and avoid deep bending

and stretching. Temporarily, there may be some pain in the area of the

implant as the incisions heal. If discomfort continues beyond two

weeks, contact your physician. If you notice excessive redness around

the wound areas during this time, contact your physician to check for

infection and administer proper treatment. In rare cases, adverse tis-

sue reaction to implanted materials can occur during this period.

Implant Location. Never attempt to change the orientation or “flip”

the implant. Do not “finger” or play with the implant. If the implant

flips over in your body it cannot be charged. If you know that the

device has turned, or if stimulation cannot be turned on after charging,

contact your physician to arrange an evaluation of the system. In

some cases, the skin over your implant may become very thin over

time. If this occurs, contact your physician.

Lead Location. In some instances a lead can move from its original

location, and stimulation at the intended pain site can be lost. If this

occurs, consult your physician who may able to restore stimulation by

reprogramming the implant in the clinic or repositioning the lead dur-

ing another operation.

Physician Implant Manual

Device Failure. Implants can fail at any time due to random compo-

nent failure, loss of battery functionality, or lead breakage. If the

device stops working even after complete charging (up to four hours),

turn off the implant and contact your physician so that the system can

be evaluated.

Storage. Do not expose the Remote Control or Charging System

components to excessively hot or cold conditions. Do not leave the

devices in your car or outdoors for extended periods of time. The sen-

sitive electronics can be damaged by temperature extremes, particu-

larly high heat. If the Remote Control or the Charging System is to be

stored for a period of time, be careful that the storage temperature

does not exceed -20–60 °C (-4–140 °F).

Handling. Handle the system components and accessories with care.

Do not drop them or submerge them in water. Although reliability

testing has been performed to ensure quality manufacturing and per-

formance, dropping the devices on hard surfaces or in water, or other

rough handling, can permanently damage the components. (See “Lim-

ited Warranty” on page 54.)

Component Disposal. Do not dispose of the Remote Control or

Charger in fire. The battery in these devices can explode in fire. Dis-

pose of used batteries in accordance with local regulations. The IPG

should be explanted in the case of cremation, and returned to

Advanced Bionics.

Remote Control, Charging System Cleaning. The components

can be cleaned using alcohol or a mild detergent applied with a cloth

or tissue. Residue from soapy detergents should be removed with a

damp cloth. Do not use abrasive cleansers for cleaning.

Safety Information

Adverse Effects

Potential risks are involved with any surgery. The possible risks of

implanting a pulse generator as part of a system to deliver spinal cord

stimulation include:

• Lead migration, resulting in undesirable changes in

stimulation and subsequent reduction in pain relief.

• System failure, which can occur at any time due to ran-

dom failure(s) of the components or the battery. These

events, which may include device failure, lead breakage,

hardware malfunctions, loose connections, electrical

shorts or open circuits and lead insulation breaches, can

result in ineffective pain control.

• Tissue reaction to implanted materials can occur.

• Skin erosion at the IPG site can occur over time.

• Possible surgical procedural risks are: temporary pain at

the implant site, infection, cerebrospinal fluid (CSF)

leakage and, although rare, epidural hemorrhage,

seroma, hematoma and paralysis.

• External sources of electromagnetic interference may

cause the device to malfunction and affect stimulation.

• Exposure to MRI can result in heating of tissue, image

artifacts, induced voltages in the neurostimulator and/or

leads, lead dislodgement.

• Undesirable stimulation may occur over time due to cel-

lular changes in tissue around the electrodes, changes in

electrode position, loose electrical connections and/or

lead failure.

• The patient may experience painful electrical stimula-

tion of the chest wall as a result of stimulation of certain

nerve roots several weeks after surgery.

Physician Implant Manual

• Over time, the implant may move from its original posi-

tion.

• Weakness, clumsiness, numbness or pain below the

level of implantation.

• Persistent pain at the IPG or lead site.

Safety Information

Instructions for the Physician

Implanted Stimulation Devices. If such implanted devices are

indicated for the patient, careful screening is required to determine if

safe results can be achieved before permanently implementing con-

current electrical therapies.

Postural Changes. Depending on the activity level of the patient,

postural changes may affect stimulation intensity. Instruct patients to

keep the Remote Control at hand at all times, and ensure that they

understand how to adjust stimulation levels.

Medical Devices/Therapies. If the patient is required to undergo

lithotripsy, electrocautery, external defibrillation, radiation therapy,

ultrasonic scanning, or high-output ultrasound:

• Turn off stimulation at least five minutes before the pro-

cedure or application.

• All equipment, including ground plates and paddles,

must be used as far away from the IPG as possible.

• Bipolar electrocautery is recommended. Do not use

monopolar electrocautery.

• Every effort should be taken to keep fields, including

current, radiation, or high-output ultrasonic beams,

away from the IPG.

• Equipment should be set to the lowest energy setting

clinically indicated.

• Instruct patients to confirm IPG functionality following

treatment by turning on the IPG and gradually increas-

ing stimulation to the desired level.

Sterilization

• Before implanting the IPG, inspect the condition of the

sterilization indicator and the sterile package before

Physician Implant Manual

opening the package and using the contents. Do not use

the contents if the indicator lines are not red, if the pack-

age is broken or torn, or if contamination is suspected

because of a defective sterile package seal.

• Do not resterilize the IPG. If resterilization is required,

obtain a sterile device for implantation.

• The IPG is for single use only. Do not reuse.

Safety Information

Handling

Handle the IPG and implanted accessories with care.

• Keep sharp instruments away from the components.

• Do not use the IPG if it has been dropped on a hard sur-

face from a height of more than one foot.

• Do not incinerate an IPG. Improper disposal of the

device could result in an explosion. Devices should be

explanted in the case of cremation, and returned to

Advanced Bionics Corporation.

Storage

• Store the IPG between 0° C and 45° C (32° F and

113° F). Devices should always be kept in temperature

regulated areas within the acceptable temperature range.

IPG damage can occur at temperatures outside of this

range.

Physician Implant Manual

Package Contents

(1) Precision Pulse Generator

(1) Hex Wrench

(1) Tunneling Tool

(1) Tunneling Tool Extension

(1) IPG Pocket Template

(1) Skin Marker

(2) Connector Plugs

(1) Device Registration Form

(1) Temporary Patient Identification Card

(1) Manual

Patient Identification

Please ensure that the patient receives a completed temporary identifi-

cation card following surgery. Permanent cards will be mailed directly

to the patient following patient registration.

Physician Implant Manual

Guidelines for Permanent Implantation

This section details the procedures for

• tunneling the lead/extension as part of an IPG implant,

and

• connection of lead/extension to the IPG.

The Tunneling Tool Assembly used in this procedure is provided with

the Precision device as part of the IPG Kit.

Percutaneous Lead/Extension Removal

Before revising a trial system for chronic stimulation, the nonsterile

portion of the lead or extension must be removed. The method chosen

from the choices below will depend upon how the patient was pre-

pared for the trial phase.

Remove bandages and properly cleanse the exit site.

Option A. Temporary Lead Removal

Remove the lead(s) completely and discard them.

Option B. Extension Removal

1. Open the midline incision to expose the lead and connector.

Guidelines for Permanent Implantation

2. Cut the lead extension at the connector.

3. Pull the lead extension through the tunnel and away from body at

the externalized site.

4. Loosen the connector setscrew using the torque wrench provided.

Disconnect and discard the connector.

Note: Connect a new lead extension, if necessary, to reach the

selected IPG site.

Physician Implant Manual

IPG Implantation

1. Ensure that the area surrounding the lead entry site is incised to a

dimension that will accommodate the tunneling tool. Check that

the lead is securely sutured with the suture sleeve.

2. Select and mark the intended IPG site several inches away from

the previously externalized leads, and create an incision at the top

of the implant site. (Common sites are the abdomen, upper but-

tock, or subclavicular area.)

3. Create a subcutaneous pocket no larger than the IPG outline at a

depth less than 3/4 inch (2.0 cm) from the surface.

Note: • Using the template will help guide the correct pocket sizing.

It is important to keep the pocket small to reduce the

chances of patient manipulation and IPG flipping.

•Implant charging could become ineffective at depths greater

than 3/4 inch (2.0 cm).

Guidelines for Permanent Implantation

Tool Assembly

The tunneling tool provided with the IPG includes a shaft extender to

be used for up to two leads.

1. Attach the handle to the tunneling tool shaft by turning the lock-

ing mechanism clockwise.

Note: For more length, attach the shaft extension to the handle, and

then attach the carrier shaft.

2. Thread the tip cover onto the tunneling tool and tighten by turn-

ing clockwise.

Tunneling The Lead

1. Mark the desired route of the tunnel.

2. Administer the appropriate local anesthetic along the tunneling

path.

Tool Handle

Locking Mechanism

Shaft Extension

Shaft

Carrier Tip Cover

Physician Implant Manual

Note: Check that the tunneling tool tip is securely threaded onto the

carrier.

3. OPTIONAL. If necessary, bend the tool shaft to conform to the

patient’s body.

CAUTION: Do not bend locking joints.

4. Create a subcutaneous tunnel from the IPG site to the midline

incision.

Note: Deep tunneling is not recommended.

Guidelines for Permanent Implantation

5. Once the tunneling tip is completely exposed at midline, press it

toward the shaft and turn it counterclockwise to remove it for

access to the carrier.

Note: You may feel the tip slide back before the cover begins to

unscrew.

Physician Implant Manual

6. Carefully position each lead or extension into the carrier shaft

and press the lead/extension into the groove.

Note: If necessary, swivel the carrier by pulling it away from the

handle and turning it to get better access to the cavities.

7. Gently pull the tunneling tool back through the tunnel.

Guidelines for Permanent Implantation

8. Gently lift the lead(s) out of the locking groove(s).

9. Wipe off any fluids from the proximal end of the lead(s).

Connecting To the IPG

Dual Lead Connection

• Superior (upper or left) leads connect to IPG port 1-L.

• Inferior (lower or right) leads connect to IPG port 2-R.

Single Lead Connection

• Connect a single lead to IPG port 1-L.

• Plug port 2-R with the connector plug supplied in the

IPG Kit.

Physician Implant Manual

1. Fully insert the lead(s) into the IPG port(s). When the lead is

properly inserted, the lead will stop and the retention ring will be

located under the setscrew.

2. Pass the torque wrench through the slit in the septum located on

the top of the IPG header and tighten both set screws, one at a

time, until the torque wrench “clicks,” indicating lock.

Guidelines for Permanent Implantation

CAUTION: Ensure that the lead is fully inserted before tightening the

setscrew to prevent lead damage.

Note: • If the connector plug is used in port 2-R, it is still necessary

to tighten the setscrew as described.

•The wrench is torque-limited and cannot be overtightened.

•Ensure that the lead is fully inserted before tightening the

setscrew to prevent lead damage.

•If there appears to be an obstruction when inserting the

lead, lead extension, or connector plug, use the torque

wrench to loosen (counterclockwise) the setscrew and/or

gently rotate the lead to help advance the proximal end.

3. Place the IPG in the subcutaneous pocket with “This Side Up”

facing towards the skin.

4. Coil excess lead or extension under the IPG.

Note: To confirm good connections, check impedances before

tightening the setscrew.

5. Secure the IPG in the pocket by suturing through the holes in the

connector.

6. Close and dress the wound(s).

Physician Implant Manual

IPG Explant or Replacement

1. Turn off the IPG.

2. Surgically open the IPG pocket and withdraw the device.

3. Unscrew the connector setscrews to release and remove the leads.

4. For replacement, connect the new IPG following steps 1-6 of

“Connecting to the IPG,” preceding. Or, to terminate therapy, sur-

gically remove the implanted lead system.

Rechargable Implant System

The Precision spinal cord stimulator is rechargeable. Depending on

stimulation power usage and programming, the majority of patients

will need to recharge the implant once per week. High power users

will require more frequent charging. Advanced Bionics recommends

any recharge schedule (daily, bi-daily, weekly, bi-weekly) that fits the

patient’s schedule and lifestyle while maintaining sufficient charge to

maintain stimulation.

The Clinician Programmer will estimate charging time based on 24

hours per day of stimulation at the programmed settings. Recharge

time can range from ten minutes to four hours. Patients should be

instructed to charge until the Charger emits an end of charge beep sig-

nal. The recharging process is important, but simple.

The rechargeable implant battery should provide at least five years of

service. Over time and repeated charging, the battery in the implant

will lose its ability to recover its full capacity. As a result, the implant

may require increased recharge time and/or shorter intervals between

charges after five years of service. The implant will need replacement

when stimulation can no longer be maintained with routine charging.

IPG Battery Status

When the patient Remote Control communicates with the implant, the

battery status is sent to the remote, which will display a message

when the stimulator battery is low and when the stimulator battery is

empty. When the remote indicates a low battery (message: Recharge

Stimulator Soon) the implant should be recharged as soon as possible.

Failure to recharge will lead to loss of stimulation in less than 24

Physician Implant Manual

hours, and the implant will need to be charged for approximately two

hours before reactivation.

If the patient reports that stimulation has stopped but does not also

report having seen the Remote Control warning messages “Recharge

Stimulator Now” and “Must Recharge,” instruct the patient to check

the implant battery status with the Remote Control first. If the mes-

sage sequence is displayed, inform the user that the IPG must be

recharged within three days or he/she runs the risk of needing to

return to the clinic for reprogramming.

If the patient reports seeing a “No Response” message on the Remote

Control screen, the lack of communication is probably due to a low

battery. Instruct the patient to recharge the implant, and then try using

the remote again.

Charging Steps

The Charger Base Station should be plugged in and the charger placed

in the cradle until the indicator light is green. If the indicator is amber-

colored, the charger may not be able to fully charge the implant.

Users may wear the charger over the implant using a Velcro® belt or

adhesive patches. Advanced Bionics recommends using the Velcro®

belt for charging.

Rechargable Implant System

1. While the Charger is seated in the Base Station, check that the

indicator light is green.

2. Remove the Charger from the Base Station. (The indicator light

will go out, regardless of the ready status of the Charger.)

Note: If the implant is not recharged as recommended, stimulation

will eventually stop due to a low battery. If this happens, the

implant must be recharged within three days from loss of

stimulation. If stimulation stops and you have lost or cannot

get to your charger within five days, contact Customer Service

immediately at (866) 360-4747.

If discontinuing stimulation for an extended period of time, the

implant should first be fully charged. Additionally, the implant

should be fully charged every month if stimulation is not used.

Physician Implant Manual

3. Apply the adhesive to the backside of the Charger by peeling the

clear device side liner from the patch and applying the patch to

the device, as shown, and then remove the skin side beige liner

from the adhesive (only good for one fixation).

Place the Charger into the Velcro® belt with the power button

facing out.

4. Press the power button, the large blue center of the Charger, to

turn on the Charger. The indicator light will return to the status

color (green or amber), and the Charger will begin beeping

steadily to signal that it is searching for the implant.

Rechargable Implant System

5. Locate the Charger over the IPG. When the Charger is correctly

aligned with the IPG, the beeping will stop. Press the Charger

with the adhesive, or secure the Velcro® belt at this time.

Note: • If the Charger loses contact with the IPG during charging,

the steady alignment beep will sound. Readjust the belt or

reapply the adhesive.

6. When the Charger emits a distinct double beep, the implant is

charged.

Physician Implant Manual

Patient Remote Control

Basic Operation

The Remote Control communicates with the implant through a radio

frequency (RF) telemetry link from a distance of up to two feet. When

it is not being used, the remote is in an idle (or sleep) mode from

which it can be reactivated by any button press. During normal patient

use, the device will transition to idle mode automatically after 60 sec-

onds of non-use.

Some remote functions (i.e., patient Options and Clinician Mode) are

accessed via a “long button press” (press and hold for approximately

three seconds). These are identified in the appropriate sections fol-

lowing.

Program Button

Area Button

Stimulation On/Off Button

Up/Activate

Down/Save

Patient Remote Control

Stimulation On/Off

Stimulation is turned on and off via a dedicated power switch on the

Remote Control keypad. Simply press the stimulation on/off button at

any time to change the stimulation status of the implant.

Stimulation Amplitude

The Level screen is the Remote Control’s “default” screen. The

remote will automatically return to this screen within 15 seconds of

any button activity.

Note: When there is no button activity for more than 60 seconds, the

Remote Control will transition to idle mode and the display

screen will be blank.

Press the S or T button from the Level screen to decrease or

increase amplitude.

The Level screen also displays a bar graphic in the upper right corner

to indicate the battery charge level of the implant. Three filled-in bars

represents a fully-charged battery. As the battery strength is reduced,

depending on the patient’s stimulation settings and usage, the bars

will “empty” accordingly. Patients are encouraged to recharge the

implant at the first “Recharge Battery Soon” message displayed by

the Remote Control.

Physician Implant Manual

Coverage Area Selection

1. Press the Cbutton as needed from the Level screen to cycle to a

specific stimulation coverage area.

2. Press the S or T button to adjust the amplitude of the selected

area.

Program Selection

Note: The most recently retrieved or saved program will be

underlined. Empty program slots are denoted by an X.

1. Press the Dbutton as needed from the Level screen to cycle to a

specific saved program.

2. Press S to activate the selected program.

Modifying and Saving Programs

1. Press Das needed from the Level screen to cycle to the desired

program.

Note: The most recently retrieved or saved program will be

underlined. Empty program slots are denoted by an X.

Patient Remote Control

2. Press S to activate the selected program.

3. After the remote times out to the Level screen, you may change

the amplitude of all areas in the program, or you may adjust the

Rate or Pulse Width of an individual area by navigating to the

Options settings (see “Options” on page 40).

4. To save/store changes, select the program again and press T.

You will be required to confirm the adjustment first.

5. Press Dto confirm, or press the Cbutton to cancel the opera-

tion.

Physician Implant Manual

Note: To save the modifications as a new program, simply select an

empty (X) program slot and press Tinstead of overwriting the

existing program.

Options

With the Precision SCS system, the Rate and Pulse Width parameters

are generally considered programming “options” in that relatively few

patients will actually use these settings. By default, Rate and Pulse

Width are off-limits to the patient Remote Control unless you allow

access using BionicNavigator software.

Another option, “Restore,” is readily available to all patients. The

Restore feature allows patients to return a program to the original set-

tings you programmed for them at the initial fitting or at a follow-up.

To Access the Rate and Pulse Width Options:

1. Press and hold the Cbutton for three seconds (a long button

press) or until the Rate Area 1 screen appears.

2. As necessary, press the Cbutton normally to cycle to the area

you wish to adjust.

Patient Remote Control

3. When the desired area screen is displayed, press S or T to

increase or decrease the Rate.

4. To continue with a Pulse Width adjustment, press and hold the

Area button from any Rate Area screen to navigate to Pulse

Width Area 1.

5. As necessary, press the Cbutton normally to cycle to the area

you wish to adjust.

6. When the desired area screen is displayed, press S or T to

increase or decrease the Pulse Width.

To Access the Restore Option

1. Press and hold Dto reach Restore Program 1.

2. If necessary, press the Dbutton again (normal press) to cycle

through the programs and select the program to be restored.

3. Press S to restore the last clinic-programmed settings..

Device Linking

A Remote Control can communicate with only one stimulator at a

time. This prevents the remote from accidentally controlling an unin-

tended device. For this reason, the initial step in the linking process

involves the Remote Control identifying, by telemetry, the intended

Physician Implant Manual

stimulator for communication.The second step in establishing the link

depends on:

• Whether the stimulator is an External Trial Stimulator

(ETS) or an IPG;

• Whether the Remote Control or the stimulator has

stored programs or whether they are clear of programs;

• Where a different program set is present in both devices,

which set is to be cleared.

An un-linked Remote Control will display the following message

upon first activation (when any button is pressed) or immediately fol-

lowing a de-linking action:

Patient Remote Control

1. Press Dto initiate communication between the remote and the

stimulator within telemetry range. The remote will identify the

device by ID number.

2. Press Dto confirm and continue.

The Precision system software will automatically detect whether the

stimulator is a trial or a permanent device, and whether program sets

are available and where. If both the Remote Control and the target

stimulator are clear of programs, the link is completed immediately

and you will see this message:

However, if programs are present in either device during linking, you

will be required to respond to one or more “decision” screens to guide

the remote to complete the linking with the desired program set saved

Physician Implant Manual

to the desired device (remote or stimulator). You may also need to

enter the clinician’s password.

If an error occurs during the process or if the password is incorrect

linking will be aborted. For further information, including informa-

tion about the clinician’s password, see “To Clear Link” following.

Clinician Options

Patient-restricted clinician screens provide access to:

• Remote Control and stimulator clearing and relinking

• Communication with the clinician programmer

• Electrode impedance monitoring

To access clinician screens:

1. Press the Cand Dbuttons simultaneously for approximately

three seconds. The Enter Clinician Options screen will appear as

shown below.

2. Press the appropriate button to select an option.

Each option is discussed in sequence below.

Patient Remote Control

To Clear Link

When the Dbutton is pressed from the Enter Clinician Options

screen, you will immediately be required to enter the clinician’s pass-

word in order to continue.

To enter the password:

The first character is highlighted when the Enter Password screen

opens. To select/confirm any character and/or move to the next char-

acter position, press D. To scroll through possible characters, use S

or T.

Physician Implant Manual

When clearing a link: If the password is entered correctly, the link

between the Remote Control and the “previous” stimulator is broken

immediately , and the remote displays the Not Linked screen. The

Remote Control’s programs remain intact. If the password is entered

incorrectly, the process is aborted and the remote will return to the

Enter Clinician Options screen.

Note: If the password is entered incorrectly during an attempt to link

the Remote Control, the process is aborted and the remote

returns to the Idle screen.

For CP Mode

1. From the Enter Clinician Mode screen (See page 44), press the

C button to prepare the Remote Control for communication with

the Clinician’s Programmer (CP).

Note: The remote will remain CP Ready for 15 minutes.

Patient Remote Control

2. Place the remote and the IR dongle in the IR Holder with their

communication ports facing.

3. Plug the dongle’s USB connector into the slot in the CP and

power-on the programmer.

4. Launch the BionicNavigator software and wait for the IR Com-

munication Established display.

For Impedances

When S is selected from the Enter Clinician Options screen, the

Remote Control will take the measurements via telemetry; this will

take a few seconds.

Physician Implant Manual

Eventually, the remote will display the Electrode Impedance Sta-

tus screen.

Electrodes 1 through 8 (lead position 1-L) are represented by the

rectangles in the top row; electrodes 9 through 16 (lead position

2-R) are represented by the rectangles in the bottom row.

Electrodes within the acceptable impedance range are displayed as

solid rectangles; high impedance electrodes (above 4500 ohms) are

represented by hollow rectangles.

Note: • The Remote Control will terminate the CP Ready state and

transition to the idle mode if there is no IR signal after 15

minutes.

•All buttons are active during CP Ready and pressing any

button returns the Remote Control to the Level screen.

•Stimulation may be turned on or off during CP Ready.

•Once IR Communication is established, the Remote Control

will terminate communication and transition to the idle

mode if there is no IR activity after 15 minutes.

•All buttons are active during IR Communication and press-

ing any button returns the Remote Control to the Level

screen.

Patient Remote Control

•Whenever the remote is re-activated from idle mode the dis-

play will default to the Level screen.

Programmer Communication

The Clinician Programmer can communicate with either an External

Trial Stimulator or an IPG. In order to begin a programming session,

the CP and the Remote Control IR windows must be aligned.

Arrange for the patient to be seated within two feet of the Remote

Control to ensure a complete communication link from the program-

mer to the stimulator.

For instructions on how to use the Clinician Programmer with the

BionicNavigator software to program the IPG and transfer programs

to the Remote Control, see the BionicNavigator Software Guide.

Physician Implant Manual

Specifications and Technical Data

Materials

Parameter Range Default

Areas (Channels) 4 —

Amplitude 0 – 20 mAa

a.The Precision System includes programmable cover-

age areas with each individual electrode contact limited

to 12.7 mA. A programming interlock is enforced to

limit the coverage area output current to 20 mA or less.

For example, a maximum current output of 12.7 mA on

a first electrode would limit the total summed current

output on remaining electrodes to 7.3 mA within one

coverage area.

0 mA

Rate 0 – 1200 ppsb

b.Only one Area is available if the rate is 130 pps.

40 pps

Width 0 – 1000 µsec 210 µsec

Cycle 0 – 90 min, OFF OFF

Ramp ON 1 – 10 secs 3 secs

Contacts 1 – 16; +, -, OFF 1 – 16: OFF

Case Titanium

Header Epoxy

Strain Relief Silicone

Size/Volume 55mm x 45mm x 11mm / 22 cm3 (including header)

Maximum Current Amplitude per Electrode versus Impedance

Physician Implant Manual

Registration Information

Registering the Implant

In accordance with international practice and regulatory legislation in

some countries, a registration form is packed with each Advanced

Bionics Corporation neurostimulator.

The purpose of this form is to maintain traceability of all products and

to secure warranty rights. It also allows the institution involved in the

evaluation or replacement of a specific implanted lead, accessory or

device to gain quick access to pertinent data from the manufacturer.

Fill out the registration form included in the package contents. Return

one copy to Advanced Bionics, keep one copy for patient records, and

provide one copy to the patient and physician.

Advanced Bionics Corporation

25129 Rye Canyon Loop

Valencia, California 91355

Attention: Customer Service Department

Technical Service

Advanced Bionics Corporation has highly trained service profession-

als located worldwide to assist you. The Technical Service Depart-

ment is available to provide technical consultation 24 hours a day.

In North America, please call (866) 566-8913 to speak to a represen-

tative.

Physician Implant Manual

Limited Warranty

Advanced Bionics® Corporation (hereinafter referred to as Advanced

Bionics®) warrants to the patient who receives a Precision™ System

that the implanted pulse generator (hereinafter referred to as the IPG,

Model SC 1110, is free from defects in workmanship and materials

for a period of one (1) year from the date of surgical implant of the

IPG. This warranty only applies to the patient (recipient, hereinafter

referred to as the patient), and no other individual.

An IPG that fails to function within normal tolerances within (1) year

from the date of surgery is covered under this Limited Warranty. The

liability of Advanced Bionics® under this warranty shall be limited to:

(a) replacement with a functionally equivalent IPG; or (b) full credit

equal to the original purchase price to be applied towards the purchase

of a new IPG. Product claims under Advanced Bionics® Limited War-

ranty are subject to the following conditions and limitations:

1. The product registration card must be completed and returned to

Advanced Bionics® within 30 days of surgery in order to obtain

warranty rights.

2. The IPG must be returned to Advanced Bionics® (or authorized

agent) within 30 days of malfunction or discovery of defect, and

shall be the property of Advanced Bionics®.

3. The IPG must be implanted prior to the “use before” date.

4. Failure of the IPG must be confirmed by Advanced Bionics®.

This warranty specifically excludes defects or malfunctions

caused by: (a) fire, floods, lightning, natural disasters, water

damage and other calamities commonly defined as “Acts of

God”; (b) accident, misuse, abuse, negligence, or the customer’s

failure to operate the IPG in accordance with manufacturer's

instructions; (c) unauthorized attempts to repair, maintain, or

modify the equipment by the customer or any unauthorized third

party; or (d) attachment of any equipment not supplied by

Advanced Bionics® without prior approval.

Limited Warranty

a. This warranty does not include the leads, extensions or

surgical accessories used with the Precision™ IPG.

5. The decision as to product replacement or credit shall be made

solely at the discretion of Advanced Bionics®. For a replacement

IPG, the warranty will run only to the end of the warranty period

for the original IPG that was replaced.

This warranty is in lieu of any other warranty, expressed or implied,

including any warranty of merchantability or fitness for intended use.

Except as expressly provided by this Limited Warranty, Advanced

Bionics® shall not be responsible or liable for any direct, consequen-

tial or incidental damages caused by device malfunction, failure or

defect, whether the claim is based on warranty, contract, tort or other-

wise.

Physician Implant Manual

The following is federal government communications regulation

information about the Precision™ System.

This device complies with part 15 of the FCC Rules. Operation is sub-

ject to the following two conditions: (1) This device may not cause

harmful interference, and (2) This device must accept any interfer-

ence received including interference that may cause undesired opera-

tion.

The Precision™ System components should only be serviced by

Advanced Bionics. Do not attempt to open or repair any of the com-

ponents. Unauthorized opening of or attempts to repair the compo-

nents will void the warranty.

Changes of modifications to this product not authorized by Advanced

Bionics Corporation could void the FCC Certification and negate

your authority to operate this product.

Boston Scientific Neuromodulation PSC5210W Precision SCS System Remote Control User Manual II Physicans Implant

Boston Scientific Neuromodulation Corporation Precision SCS System Remote Control II Physicans Implant

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