Boston Scientific Precision spectra Guía de configuración rápida

CAUTION: Federal law restricts this device to sale,

distribution and use by or on the order of a physician.

Precision Spectra™ System

Information for Prescribers

90668524-11 REV A

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Precision Spectra™ System Information for Prescribers

90668524-11 REV A ii of iv

Information for Prescribers

documents are the property of Boston Scientic Corporation and shall not be

reproduced, distributed, disclosed, or used for manufacture or sale of device without

the express written consent of Boston Scientic Corporation.

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.

Trademarks

Precision Spectra is a trademark of Boston Scientic. Other brands and their

products are trademarks or registered trademarks of their respective holders and

should be noted as such.

Precision Spectra™ System Information for Prescribers

90668524-11 REV A iii of iv

Refer to the Indications for Use for indications and related information.

Refer to the following Directions for Use (DFU) for device specic instructions: Precision

Spectra System Implantable Pulse Generator DFU, Surgical Leads DFU, Percutaneous

Leads DFU, Precision Spectra System Clinician Remote Control DFU, Clinician Trial Manual,

Precision Spectra System Programming Manual, and Programming Wand DFU. Refer to the

Labeling Symbols Addendum for an explanation of labeling symbols.

Refer to the Limited Warranty for warranty information.

Table of Contents

Device and Product Description ...................................................................1

Contraindications...........................................................................................1

Safety Information..........................................................................................1

Instructions for the Patient..................................................................................................1

Instructions for the Physician.............................................................................................. 6

Sterilization .........................................................................................................................7

EN 60601-1-2 Classication Information ............................................................................8

Technical Service................................................................................................................9

End of Programmed Service............................................................................................... 9

IPG Battery Life ..................................................................................................................9

Contacting Boston Scientic.............................................................................................10

Precision Spectra™ System Information for Prescribers

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Information for Prescribers

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Device and Product Description

Precision Spectra™ System Information for Prescribers

90668524-11 REV A 1 of 165

Device and Product Description

The Precision Spectra™ Spinal Cord Stimulation System consists of an Implantable Pulse

Generator (IPG), temporary and permanent Percutaneous Leads, Surgical Paddle Leads,

Lead Extensions, OR Cables, Trial Stimulator, Remote Control, Clinician Programmer, and

Programming Wand, each packaged as a separate kit. Single use accessories and disposable

tools are also included in these kits.

Features of the Precision Spectra System include:

• Stimulation electrode eld navigation

• Thirty-two independent current-controlled electrodes

• Four programmable stimulation areas per program; sixteen possible programs

• Long-life operation

• High-range parameter capability

• Small size

• Two-foot programming range

• This product contains no detectable latex

Contraindications

Patients contraindicated for permanent Spinal Cord Stimulation (SCS) therapy are those who:

• are unable to operate the SCS system

• have failed trial stimulation by failing to receive effective pain relief

• are poor surgical risks

• are pregnant

Safety Information

WARNING: Unauthorized modication to the medical devices is prohibited. System integrity

could be compromised and harm or injury to the patient could occur if the medical devices are

subjected to unauthorized modication.

Instructions for the Patient

Warnings

Heat Due to Charging. Patients should not charge while sleeping. This may result in a burn.

While charging, the Charger may become warm. It should be handled with care. Failure to

use the Charger with either the Charging Belt or an adhesive patch, as shown, may result in a

burn. If patients experience pain or discomfort, they should cease charging and contact Boston

Scientic.

Information for Prescribers

Precision Spectra™ System Information for Prescribers

90668524-11 REV A 2 of 165

Magnetic Resonance Imaging (MRI). Patients implanted with the Precision Spectra 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 stimulation 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, causing 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 debrillators. The effects of

implanted stimulation devices on neurostimulators is unknown.

Stimulator 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 posture 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 making

posture changes.

Important: If unpleasant sensations occur, the IPG should be turned off immediately.

Electromagnetic Interference. Strong electromagnetic elds 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

proceed through the device, the patient should turn off the Stimulator and proceed with

caution, moving 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

Safety Information

Precision Spectra™ System Information for Prescribers

90668524-11 REV A 3 of 165

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 Stimulator, particularly if used in close

proximity to the device:

• lithotripsy

• electrocautery (See “Instructions for the Physician” on page 6)

• external debrillation

• radiation therapy (Any damage to the device by radiation may not be immediately

detectable.)

• ultrasonic scanning

• high-output ultrasound

If any of the above is required by medical necessity, refer to “Instructions for the Physician” on

page 6. Ultimately, however, the device may require explantation as a result of damage to

the device.

Automobiles and Other Equipment. Patients should not operate automobiles, other

motorized vehicles, or potentially dangerous machinery/ equipment with therapeutic stimulation

switched on. Stimulation must be turned off rst. Sudden stimulation changes, if they occur,

may distract patients from attentive operation of the vehicle or equipment.

Post Operative. During the two weeks following surgery, it is important that patients use

extreme care so that appropriate healing will secure the implanted components and close the

surgical incisions:

• Patients should not lift objects of more than ve pounds.

• Patients should not engage in rigorous physical activity such as twisting, bending, or

climbing.

• If new leads were implanted, patients should not raise their arms above their head.

Temporarily, there may be some pain in the area of the implant as the incisions heal. Patients

should be instructed that if discomfort continues beyond two weeks, they should contact their

physician.

If patients notice excessive redness around the wound areas during this time, they should

contact their physician to check for infection and administer proper treatment. In rare cases,

adverse tissue reaction to implanted materials can occur during this period.

Patients should consult their physician before making lifestyle changes due to decreases in

pain.

Information for Prescribers

Precision Spectra™ System Information for Prescribers

90668524-11 REV A 4 of 165

Stimulator Location. Patients should never attempt to change the orientation or “ip” (rotate

or spin) the Stimulator. Patients should not “nger” or play with the Stimulator. If the Stimulator

ips over in the Patient’s body, it cannot be charged. If the Patient knows that the device has

turned, or if stimulation cannot be turned on after charging, the Patient should contact his or her

physician to arrange an evaluation of the system. In some cases, the skin over the Stimulator

may become very thin over time. If this occurs, Patients should contact their physicians.

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, Patients should consult their physician who

may able to restore stimulation by reprogramming the Stimulator in the clinic or repositioning

the lead during another operation.

Device Failure. Stimulators can fail at any time due to random component failure, loss of

battery functionality, or lead breakage. If the device stops working even after complete charging

(up to four hours), Patients should turn off the Stimulator and contact their physician so that the

system can be evaluated.

Operating Temperature. The operating temperature of the Trial Stimulator, Remote Control,

and Programming Wand is 10–40 °C (50–104 °F). For proper operation, do not use the

Charger if the ambient temperature is above 35 °C (95 °F).

Storage, Handling and Transport. 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 sensitive electronics can be damaged by

temperature extremes, particularly high heat.

If the Remote Control or the Charging System is to be stored for a period of time without

batteries, the storage temperature should not exceed -20 to 60 °C (-4 to 140 °F).

Handle the system external 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 performance, dropping the devices on hard surfaces or in water, or other

rough handling, can permanently damage these components. (See “Limited Warranty - IPG”.)

Upon completion of the Patient Trial, remove the batteries from the Trial Stimulator.

Component Disposal. Do not dispose of the Remote Control or Charger in re. The battery

in these devices can explode in re. Dispose of used batteries in accordance with local

regulations. The IPG should be explanted in the case of cremation, and returned to Boston

Scientic. External devices to be disposed of per local regulatory requirements. Please contact

your healthcare professional.

Safety Information

Precision Spectra™ System Information for Prescribers

90668524-11 REV A 5 of 165

Remote Control, Charging System, External Trial Stimulator and Wand Cleaning. The

charging system components can be cleaned using alcohol or a mild detergent applied with a

cloth or tissue. The Remote Control, External Trial Stimulator and Programming Wand can be

cleaned using a mild detergent applied with a lightly dampened cloth or tissue. Residue from

soapy detergents should be removed with a cloth lightly dampened with water. Do not use

abrasive cleansers for cleaning.

Cell Phones. While we do not anticipate any interference with cell phones, the full effects

of interaction with cell phones are unknown at this time. If there is a concern or a problem is

encountered, the patients should contact their physician.

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 random 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. In some cases, the formation of reactive

tissue around the lead in the epidural space can result in delayed onset of spinal cord

compression and neurological/sensory decit, including paralysis. Time to onset is variable,

possibly ranging from weeks to years after implant.

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

• Possible surgical procedural risks are: temporary pain at the implant site, infection,

cerebrospinal uid (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 cellular changes in tissue around the

electrodes, changes in electrode position, loose electrical connections and/or lead failure.

• The patient may experience painful electrical stimulation of the chest wall as a result of

stimulation of certain nerve roots several weeks after surgery.

• Over time, the Stimulator may move from its original position.

• Weakness, clumsiness, numbness or pain below the level of implantation.

• Persistent pain at the IPG or lead site.

In any event, instruct the patient to contact their physician to inform him/her.

Information for Prescribers

Precision Spectra™ System Information for Prescribers

90668524-11 REV A 6 of 165

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 concurrent 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 on hand at all times, and

ensure that they understand how to adjust stimulation levels. Refer to Postural Changes in the

Instructions for Patients section of this manual, page 2, for additional information.

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

external debrillation, radiation therapy, ultrasonic scanning, or high-output ultrasound:

• Turn off stimulation at least ve minutes before the procedure or application.

• All equipment, including ground plates and paddles, must be used as far away from the IPG

as possible.

• Every effort should be taken to keep elds, 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 conrm IPG functionality following treatment by turning on the IPG and

gradually increasing stimulation to the desired level.

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