Boston Scientific Vercise PC ETS2 Istruzioni per l'uso

Vercise™ PC

Information for

Prescribers

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Directions for Use

Instrucciones de uso

Mode d’emploi

Gebrauchsanweisung

Istruzioni per l’uso

Gebruiksaanwijzing

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Instruções de Utilização

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Указания по использованию

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92190993-02

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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.

Trademarks

All trademarks are the property of their respective holders.

Additional Information

For other device-specic information not included in this manual, or labeling symbols, refer to the

appropriate DFU as listed on your DBS Reference Guide.

Registration Information

In accordance with international practice and regulatory legislation in some countries, a registration

form is packed with each Boston Scientic Stimulator, DBS Lead, and DBS Extension. 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 specic implanted DBS 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 the Boston

Scientic Customer Service Department, keep one copy for patient records, provide one copy to

the patient, and save one copy for the physician.

Boston Scientic

Neuromodulation Corporation

Attention: Customer Service Department

25155 Rye Canyon Loop

Valencia, CA 91355, USA

Table of Contents

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Table of Contents

Vercise™ PC DBS System Description ...................................... 1

Intended Use / Indications for Use .............................................. 1

Safety Information ........................................................................ 2

Contraindications .................................................................................2

Warnings ........................................................................................2

Precautions ...................................................................................4

Adverse Events ..............................................................................8

External Trial Stimulator 2 (ETS 2) Maintenance ....................... 11

Vercise PC Stimulator Battery ..................................................... 11

Elective Replacement ...........................................................................12

End of Service ......................................................................................12

Limited Warranty - Implantable Pulse Generator

(Stimulator) ................................................................................... 13

Non-Rechargeable Stimulator...............................................................13

Limited Warranty - Leads ............................................................ 14

Limited Warranty - Externals ....................................................... 15

Technical Support ....................................................................... 17

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Vercise™ PC DBS System Description

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Vercise™ PC DBS System Description

The Vercise PC Deep Brain Stimulation (DBS) System includes a Stimulator with DBS Leads

for unilateral or bilateral stimulation. There are also DBS Extensions that allow the DBS Leads

mounted in the skull to be extended to reach the Stimulator implanted near the clavicle. The

Vercise PC DBS System utilizes current steering across eight contacts per DBS Lead to provide

precise positioning of stimulation. The Stimulator is controlled by a hand-held Remote Control, and

can be interfaced with a Clinician’s Programmer.

The battery of the non-rechargeable stimulator will become depleted. The longevity of the

Stimulator battery depends on the following factors:

• Programmed parameters

• System impedance

• Hours per day of stimulation

• Changes to stimulation made by the patient

For additional information on estimating the longevity of the non-rechargeable battery, refer to the

appropriate programming manual as listed on your DBS Reference Guide.

Note: The Vercise PC System was not made with natural latex.

Intended Use / Indications for Use

The Vercise PC DBS System is indicated for use in the following:

• Unilateral or bilateral stimulation of the subthalamic nucleus (STN) or internal globus

pallidus (GPi) for treatment of levodopa-responsive Parkinson’s disease which is not

adequately controlled with medication.

• Unilateral or bilateral stimulation of the subthalamic nucleus (STN) or internal globus

pallidus (GPi) for treatment of intractable primary and secondary dystonia, for persons 7

years of age and older.

• Thalamic stimulation for the suppression of tremor not adequately controlled by

medications in patients diagnosed with Essential Tremor or Parkinson’s disease.

• Unilateral or bilateral stimulation of the post-commissural fornix in the treatment of

patients 65 years and older with mild probable Alzheimer’s disease, as an adjunctive

therapy for patients on a stable dose of cholinesterase inhibitor medication.

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Safety Information

Contraindications

The Boston Scientic Vercise PC DBS System, or any of its components, is contraindicated for the

following:

Diathermy. Shortwave, microwave, and/or therapeutic ultrasound diathermy. The energy

generated by diathermy can be transferred to the Vercise PC DBS System, causing tissue damage

at the contact site resulting in severe patient injury or death.

Magnetic Resonance Imaging (MRI). Patients implanted with the Vercise PC

DBS System should not be subjected to MRI. MRI exposure may result in the following:

• Dislodgement of implanted components

• Heating of the contacts, or other system components, causing permanent tissue

lesioning

• Damage to the Stimulator’s electronics

• Current induction through the DBS Leads and Vercise PC DBS System causing

unpredictable levels of stimulation

• Distortion of the diagnostic image

• Personal injury or even death

Patient Incapability. Patients who are unable to properly operate the Remote Control should

not be implanted with the Vercise PC DBS System.

Poor Surgical Risks. The Vercise PC DBS System is not recommended for patients who are

poor surgical risks.

Warnings

Unauthorized Modication. 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.

Intracranial Hemorrhage. Special precautions should be taken for patients who are prone

to hemorrhage including patients with coagulopathy, with high blood pressure, or who are using

prescribed anticoagulants. Microelectrode penetration and DBS Lead insertion can put patients

who have a likelihood of intracranial hemorrhages at greater risk.

Charge Density. High levels of stimulation may damage brain tissue. To maintain safety

limits, the software will display a message when the stimulation level would exceed the limit, and

programming of these settings will be prevented.

Patients may be granted the ability to change stimulation amplitude with the Remote Control. The

software prevents patient controlled amplitude from violating the limit.

Safety Information

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Diathermy. Shortwave, microwave and/or therapeutic ultrasound diathermy should not be used

on patients implanted with the Vercise PC DBS System, or any of the system components. The

Stimulator, whether it is turned on or off, may be critically damaged by the use of diathermy. The

energy generated by diathermy can be transferred to the Vercise PC DBS System, causing tissue

damage at the contact site resulting in severe injury or death.

Magnetic Resonance Imaging. Patients implanted with the Vercise PC DBS System,

or any of its components, should not be subjected to Magnetic Resonance Imaging (MRI). MRI

exposure may result in the following:

• Dislodgement of implanted components

• Heating of the contacts, or other system components, causing permanent tissue

lesioning

• Damage to the Stimulator’s electronics

• Current induction through the DBS Leads and Vercise PC DBS System components

causing unpredictable levels of stimulation

• Distortion of the diagnostic image

• Personal injury or even death

Electromagnetic Interference. Strong electromagnetic elds can potentially turn the

Stimulator off, cause temporary unpredictable changes in stimulation, or interfere with the Remote

Control communication. Patients should be counseled to avoid or exercise care around the

following:

• Theft detectors such as those used at entrances/exits of department stores, libraries, and

other public establishments. The patient should proceed with caution, ensuring to move

through the center of the detector as quickly as possible.

• Security screeners, such as those used in Airport Security or at entrances to government

buildings, including hand-held scanners. The patient should request assistance to bypass

the device. If the patient must pass through the security screener, they should move

quickly through the device staying as far from the physical device as allowable.

• Power lines or power generators.

• Electric steel furnaces and arc welders.

• Large magnetized stereo speakers.

• Strong magnets.

• Automobiles or other motorized vehicles using a LoJack system or other anti-theft

systems that can broadcast a radio frequency (RF) signal. The high energy elds

produced by these systems may interfere with the operation of the Remote Control and

its ability to control stimulation.

• Other sources of electromagnetic interference, such as RF transmitters at television or

radio broadcast stations, Amateur Radio or Citizens Band radio transceivers, or Family

Radio Service band transceivers.

DBS Extension Connector and Stimulator Placement. Implanting the DBS

Extension connector in the soft tissue of the neck may increase the chance of DBS Lead breakage.

Boston Scientic recommends placing the DBS Extension connector behind the ear such that

glasses or headgear do not interfere with the system. Boston Scientic recommends that the

Stimulator be placed subclavicularly.

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Stimulator Damage. Chemical burns may result if the Stimulator housing is ruptured or

pierced, exposing the patient’s tissue to battery chemicals. Do not implant the Stimulator if the

housing is damaged.

Suicide. Depression, suicidal ideation, and suicide are known risks of DBS. Consider adjustment

of stimulation, discontinuing stimulation, adjusting medication, and/or psychiatric referral.

Other Active Implantable Devices. Concurrent use of stimulators such as the Vercise PC

Stimulator and other active implantable devices such as pacemakers or cardioverter debrillators

may result in interference with the operations of the devices. If the patient requires concomitant

implantable active devices, careful programming of each system is necessary.

Automobiles and Equipment. Patients should operate automobiles, other motorized

vehicles, or potentially dangerous machinery/equipment with caution after receiving the Vercise PC

DBS System. Performing activities that would be dangerous if treated symptoms were to return, or

instances in which stimulation changes occur, should be avoided.

Pregnancy

It is unknown whether this device may cause complications with pregnancy and/or hurt an unborn

baby.

Precautions

Physician training is required for usage of the Vercise PC DBS System. The implanting physician

should be experienced in the subspecialty of Stereotactic and Functional Neurosurgery. The

following is a list of precautions that should be taken when implanting or using the DBS Stimulator.

Connections. Before inserting any DBS Lead or DBS Extension into any connector or header

ports, including the Stimulator header, DBS Extension connectors, and operating room cable

assembly, always wipe the DBS Lead with a sterile, dry cotton sponge. Contamination inside the

ports may be difcult to remove and can cause high impedances, preventing electrical connectivity

which may compromise the integrity of the stimulation circuit.

Components. The use of components other than those supplied by Boston Scientic and

intended for use with the Vercise PC DBS System may damage the system, diminish the

effectiveness of therapy, and/or put the patient at unknown risk.

Excess DBS Extension. Coil excess DBS Extension around or below the Stimulator. Excess

wire on top of the Stimulator may increase the potential for tissue erosion or damage during

Stimulator replacement surgery.

Other Models of External Devices. Only the Remote Control and Clinician Programmer

that were provided with the Boston Scientic Vercise PC DBS System should be used with the

Vercise PC DBS System. Other models of these devices will not function with the Vercise PC DBS

System.

Stimulator Orientation. Orient the Stimulator parallel to the skin surface. Suboptimal

placement of the Stimulator may result in a revision surgery. Patients should avoid touching the

Stimulator site or incisions. If patients notice a change in appearance of the skin at the Stimulator

location, such as the skin becoming thin over time, they should contact their physician.

Safety Information

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Setscrews. Before tightening Setscrews, always test impedance to conrm electrical

connectivity. Tightening a Setscrew onto a contact may damage the contact and may result in the

need to replace the DBS Lead or DBS Extension.

Sutures. Do not apply sutures tightly around the DBS Leads, as this may damage the insulation

of the DBS Lead and may result in DBS Lead failure.

Surgical Tape. If tape is used to temporarily secure the DBS Lead during surgery, caution

should be used to ensure the Lead is not cut or damaged when removing the tape.

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

functionality, or DBS Lead breakage. Suddenly stopping brain stimulation can cause serious

reactions to develop. If the Stimulator stops working, patients should be instructed to turn off

the Stimulator and contact their physician immediately so that the system can be evaluated and

appropriate medical care given to manage the return of symptoms.

Tissue Reaction. Temporarily, there may be some pain in the area of the Stimulator as the

incisions heal. If there is excessive redness around the wound area, it should be checked for

infection. In rare cases, adverse tissue reaction to implanted materials can occur.

Cell Phones. While interference with cell phones is not anticipated, the full effects of interaction

with cell phones are unknown at this time. Patients should be instructed to avoid placing the cell

phone directly over the Implanted Stimulator. If interference does occur, move the cell phone away

from the Implanted Stimulator or turn off the phone.

Patient Activities. During the two weeks following surgery, it is important for the patient to

exercise extreme care so that appropriate healing will secure the implanted components. During

this period, the patient should not attempt to move heavy objects. Instruct the patient to restrict

head movements, including extension or exion of the neck and rotation of the head, until healing

is complete.

Massage Therapy. Patients should avoid receiving massage therapy near the implanted

system components. If a patient does receive massage therapy, the patient should inform the

masseuse that they have an implanted device and show him/her where the Stimulator, DBS

Extension, and DBS Leads are located. The patient should have the masseuse avoid these areas

and proceed with caution.

Environmental Precautions. Patients should avoid activities that could potentially involve

large amounts of electromagnetic interference. Devices that contain permanent magnets, such as

speakers, should not be placed near the Stimulator because they may cause the system to turn on

or off.

Medical Devices/Therapies. The following medical therapies or procedures may turn

stimulation off, cause permanent damage to the Stimulator, or may cause injury to the patient:

• Electrocautery – Electrocautery can transfer destructive current into the DBS Leads and/

or Stimulator.

• External Debrillation – Safe usage of external debrillation has not been established

and damage should be ascertained following debrillation.

• Lithotripsy – High frequency signals directed near the Stimulator may damage circuitry.

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• Radiation Therapy – Lead shielding should be used over the Stimulator to prevent

damage from high radiation. Any damage to the device by radiation may not be

immediately detectable.

• Transcranial Stimulation – Safe use of electromagnetic therapies, such as transcranial

magnetic stimulation, have not been established.

• MRI – Patients implanted with the Vercise PC DBS System should not be subjected to

MRI to avoid damage to the device and patient harm.

• Diathermy – The energy generated by diathermy can be transferred to the Vercise PC

DBS System and may result of damage to the device or patient harm.

If any of the above is required by medical necessity, the procedure(s) should be performed as

far from the implanted components as possible. Ultimately, however, the Stimulator may require

explantation as a result of damage to the device or patient harm.

Sterilization. Contents of the surgical kits are supplied sterile using an ethylene oxide

process. Do not use if sterile barrier is damaged. If damage is found, call your Boston Scientic

representative and return the damaged part to Boston Scientic.

Resterilization. For single patient use only. Do not reuse, reprocess or resterilize. Reuse,

reprocessing or resterilization may compromise the structural integrity of the device and/or lead to

device failure which, in turn, may result in patient injury, illness or death. Reuse, reprocessing or

resterilization may also create a risk of contamination of the device and/or cause patient infection

or cross-infection, including, but not limited to, the transmission of infectious disease(s) from one

patient to another. Contamination of the device may lead to injury, illness or death of the patient. If

resterilization is desired, obtain a new sterile device for implantation.

After use, return the Stimulator, DBS Leads, and DBS Extensions to Boston Scientic and dispose

of other components and packaging in accordance with hospital, administrative and/or local

government policy.

Check the expiration date on the package before opening the sterile package and using the

contents. Do not use the contents if the current date is past the expiration date, if the package is

opened or damaged, or if contamination is suspected because of a defective sterile package seal.

• Inspect the seal integrity of the outer tray before use.

• Inspect the seal integrity and sterile indicator on the inner tray. The sterile indicator will

be green with red stripes if sterile. Yellow stripes indicate the tray is not sterile. If the tray

is not sterile, do not use the components and return to Boston Scientic.

• Open the inner tray in the sterile eld.

• If the Stimulator was dropped, do not implant it in a patient. The dropped Stimulator

may have lost sterility, experienced a loss of hermeticity, or been otherwise damaged.

Replace the dropped Stimulator with a new, sterile Stimulator prior to implantation.

Return the damaged Stimulator to Boston Scientic.

• Do not use any component that shows signs of damage.

• Do not use if “Use By” date has expired.

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

Control, and Programing Wand is 5–40 °C (41–104 °F).

Safety Information

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Storage, Handling and Transport. Store implanted components like Stimulators, Leads,

and Extensions between 0 °C to 45 °C (32 °F to 113 °F) in an area where they are not exposed

to liquids or excessive moisture. Temperatures outside of the stated range can cause damage.

If stored in conditions beyond the required storage temperature, do not use the components and

return to Boston Scientic.

The non-rechargeable Stimulator will enter storage mode if its temperature falls below 8 °C. When

the Stimulator is in storage mode, it will not connect to a Remote Control or Clinician Programmer.

To exit storage mode, increase the Stimulator temperature above 8 °C.

Store external components like the Remote Control, External Trial Stimulator, ETS Adapter, OR

Cable and Extension between -20 ° to 60 °C (-4 ° to 140 °F). Do not expose the Remote Control or

External Trial Stimulator 2 (ETS 2) 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.

Handle the system components and accessories with care. Do not drop them or submerge them

in water. Accessories, including the Remote Control, must be kept dry and not be exposed to

moisture. 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 the components. Keep the Remote Control away from pets, pests, and

children to avoid damage to the device.

Care must be taken to avoid damaging the DBS Lead with sharp instruments or excessive force

during surgery. The following guidelines will help to ensure the longevity of components:

• Do not sharply bend or kink the DBS Lead or Extension.

• Do not tie suture(s) directly to the DBS Lead or Extension body.

• Avoid pulling an implanted DBS Lead taut; stress relief loops may help to minimize

tension on the DBS Lead.

• Avoid handling the DBS Lead with sharp instruments; use only rubber-tipped forceps.

• Take care when using sharp instruments, such as hemostats or scalpels, to prevent

damaging the DBS Lead.

Component Removal & Disposal. Any explanted components should be returned to

Boston Scientic. The Stimulator should be explanted in the case of cremation and returned to

Boston Scientic. Cremation may cause the Stimulator battery to explode.

The Remote Control should not be disposed of in re, as this device contains batteries which may

explode causing injury when exposed to re. Used batteries should be disposed of in accordance

with local laws and regulations.

Cleaning the Remote Control and ETS 2. 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. Do not clean any of the

accessories while they are directly or indirectly connected to a power outlet.

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As an operator of the external devices, you should perform only the following service and

maintenance tasks on the external devices:

• Changing the battery

• Charging the battery

• Cleaning

Ensure that the devices are not in use while performing service and maintenance tasks.

Adverse Events

The following is a list of known risks with the use of deep brain stimulation. Specic adverse events

may be more relevant depending on the indication and site of stimulation. Not all risks are known.

Note that some of these symptoms may be resolved or reduced by current steering, changing

stimulation parameters, or by changing the position of the lead during surgery.

If any of these events occur, patients should inform their physician as soon as possible.

• Allergic or immune system response

• Anesthesia/neurosurgery risks, including unsuccessful implant, exposure to bloodborne

pathogens

• CSF leak

• Death, including suicide

• Embolism, including air embolism and pulmonary embolism

• Failure or malfunction of any of the device components or the battery, including but

not limited to lead or extension breakage, hardware malfunctions, loose connections,

electrical shorts or open circuits and lead insulation breaches, whether or not this

requires explant and/or reimplantation

• Hemorrhagic or ischemic stroke, immediate or delayed, which could result in temporary

or permanent neurologic decits such as muscle weakness, paralysis or aphasia

• Implant site complications such as pain, poor healing, wound reopening

• Infection

• Injury to tissues adjacent to implant or within surgical eld, such as blood vessels,

peripheral nerves, brain (including pneumocephalus), or pleura (including

pneumothorax).

• Interference from external electromagnetic sources

• Lead, extension (including extension header) and neurostimulator erosion or migration

• Loss of adequate stimulation

• Mentation impairment such as attention or cognitive decits, memory disturbances, or

confusion

• Psychiatric disturbances such as anxiety, depression, apathy, mania, insomnia, suicide,

or suicidal ideation or attempts

• Motor problems such as paresis, weakness, incoordination, restlessness, muscle

spasms, postural and gait disorders, tremor, dystonia, or dyskinesias, and falls or injuries

resulting from these problems

Safety Information

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• Musculoskeletal stiffness

• Neuroleptic malignant syndrome or acute akinesia can occur very rarely

• Overstimulation or undesirable sensations, such as paresthesia, transient or persistent

• Pain, headache or discomfort, transient or persistent, including symptoms due to

neurostimulation

• Poor initial lead location

• Radiation exposure due to imaging (CT, uoroscopy x-ray)

• Seizures

• Sensory changes

• Seroma, edema or hematoma

• Skin irritation or burns at neurostimulator site

• Speech or swallowing problems such as dysphasia, dysarthria or dysphagia, as well as

complications of dysphagia such as aspiration pneumonia

• Systemic symptoms-autonomic (tachycardia, sweating, increased blood pressure,

ushing, fever, dizziness), changes in renal function, urinary retention, sexual effects,

gastrointestinal (nausea, bowel retention, bloating)

• Thrombosis

• Undesirable sensations such as tingling or generalized warming

• Visual disturbances or periorbital symptoms, such as diplopia, eyelid movement difculty,

oculomotor difculties, transient ashes of light or other visual eld effects

• Vivid memories

• Weight changes

BS EN 60601-1-2 Classication Information

Testing to demonstrate compliance of the Vercise PC DBS System with the essential requirements

and other relevant provisions of Directive 1999/5/EC were leveraged from testing performed on the

Precision™ SCS System.

• Internally powered

• Continuous operation

• Ordinary equipment

• Class II

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Table 1: Guidance and manufacturer’s declaration – electromagnetic emissions

The Vercise PC System is intended for use in electromagnetic environment specied below.

The customer or the user of the Vercise PC System should assure that it is used in such an

environment.

Emissions Test Compliance Electromagnetic environment –

guidance

RF emissions

CISPR 11

Group 1 The Vercise PC System uses RF energy

only for its internal function. Therefore, its RF

emissions are very low and are not likely to

cause any interference in nearby electronic

equipment.

RF emissions

CISPR 11

Class B The Vercise PC System is suitable for use

in all establishments, including domestic

establishments and those directly connected

to the public low voltage power supply

network that supplies buildings used for

domestic purposes.

Harmonic emissions

IEC 61000-3-2

Not Applicable

Voltage uctuations/

icker emissions

IEC 61000-3-3

Not Applicable

Hereby, Boston Scientic declares that the Vercise PC System is in compliance with the essential

requirements and other relevant provisions of Directive 1999/5/EC.

Essential Performance

Failure of the external electrical components will not result in an unacceptable risk to the user.

Telemetry Information

The following parameters describe the wireless communication link between the Stimulator and the

Remote Control:

• Frequency Band: 119 – 131 kHz

• Modulation type: FSK

• Effective Radiated Power: 0.05 mW (-13 dBm) maximum

• Magnetic Field Strength (at 3 m distance): 46 μA/m

External Trial Stimulator 2 (ETS 2) Maintenance

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External Trial Stimulator 2 (ETS 2) Maintenance

The ETS 2 is used to conduct intraoperative stimulation testing during the lead implantation

procedure. Refer to the DFU listed on your DBS Reference Guide for detailed procedure and

guidelines for intraoperative testing.

Figure 1: External Trial Stimulator 2

To turn stimulation on and off on the ETS, press the ON/OFF button on the ETS 2 (Figure 1). When

the stimulation is on, the Stim Indicator Light will blink green. The ETS 2 runs on two AA batteries

that are provided with every ETS 2 kit. When the batteries need replacement, the Battery Indicator

Light will change from a ashing green to a ashing yellow.

Be sure that stimulation is off (the indicator light is not blinking) before opening the Trial

Stimulator’s battery compartment.

To install new batteries:

1. Conrm that stimulation is OFF by conrming that the stimulation indicator light is not blinking.

2. On the rear of the ETS 2, push in slightly and slide down the battery compartment cover.

3. Remove the old batteries.

4. Place two new AA batteries in the slots matching the positive (+) and negative (-) markings in

the compartment.

5. Align the battery compartment cover on the case and slide the cover into position until is snaps

closed.

6. Both the Battery Indicator light and the Stim On indicator lights will emit an amber glow for 15

seconds after which the Battery indicator light blinks green.

Vercise PC Stimulator Battery

The Vercise PC Stimulator has a non-rechargeable battery. The longevity of the Stimulator battery

depends on the following factors:

• Programmed parameters

• System impedance

• Hours per day of stimulation

• Changes to stimulation made by the patient.

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For additional information on estimating the longevity of the non-rechargeable battery, refer to the

appropriate programming manual as listed on your DBS Reference Guide.

Elective Replacement

When the implanted non-rechargeable Stimulator is nearing end of its battery life, the Stimulator

will enter the Elective Replacement mode. The Elective Replacement Indicator (ERI) will appear on

the Remote Control and Clinician Programmer. Changes made to the stimulation will not be saved,

and stimulation will not be available soon. Patients should be advised to contact their physician

to report this message screen. The Stimulator must be replaced to continue receiving stimulation.

Batteries that have lasted 12 months or more without entering ERI mode will have a minimum of 4

weeks between entering ERI mode and reaching End of Battery Life. Surgery is required to replace

the implanted Non-Rechargeable Stimulator, although leads may stay in place while the Stimulator

is exchanged.

End of Service

End of Battery Life

When the Stimulator battery is fully depleted, the End of Service (EOS) indicator will be displayed

on the Remote Control and Clinician Programmer. Stimulation will not be available. Surgery is

required to replace the implanted non-rechargeable stimulator to continue providing stimulation.

End of Programmed Service

The Vercise PC Stimulator software has been programmed to end service after a dened period.

When the Stimulator is within approximately 180 days of the end of its programmed period, the

Remote Control and Clinician Programmer will display a message indicating the number of service

days available.

Refer to the programming Manual and the Remote Control DFU listed on your DBS Reference

Guide for description of the End of Service messages displayed.

Limited Warranty - Implantable Pulse Generator (Stimulator)

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Limited Warranty - Implantable Pulse Generator

(Stimulator)

Non-Rechargeable Stimulator

Boston Scientic Corporation warrants to the patient who receives an implantable non-

rechargeable pulse generator (referred to as the Non-Rechargeable Stimulator) that the Non-

Rechargeable Stimulator will be free from defects in workmanship and materials for a period of

two (2) years from the date of surgical implant of the Non-Rechargeable Stimulator. This warranty

applies only to the patient who has the Non-Rechargeable Stimulator implanted and no other

person or entity. This warranty does not apply to the leads, extensions, or surgical accessories

used with the Non-Rechargeable Stimulator.

A Non-Rechargeable Stimulator that fails to function within normal ranges within two (2) years after

the date it is implanted is covered under this Limited Warranty. The liability of Boston Scientic

under this warranty shall be limited to: (a) replacement of the Non-Rechargeable Stimulator with

a functionally equivalent Non-Rechargeable Stimulator made by Boston Scientic; or (b) credit

applied towards the purchase of a new Stimulator. The warranty amount is calculated using least

expensive device price (original vs. replacement). No other relief whatsoever is available under

this limited warranty. This limited warranty for a replacement Non-Rechargeable Stimulator will last

only for two years from the date of surgical implant of the original Non-Rechargeable Stimulator.

Note: Battery life of a Non-rechargeable Stimulator may vary due to a variety of factors.

Therefore, this warranty shall not extend to battery depletion of a Non-rechargeable

Stimulator unless such depletion is caused by a defect in workmanship or material.

Claims under this limited warranty are subject to the following additional conditions and limitations:

1. The product registration card must be completed and returned to Boston Scientic within 30

days of surgery.

2. The Non-Rechargeable Stimulator must be implanted before the “Use By” date.

3. Failure of the Non-Rechargeable Stimulator must be conrmed by Boston Scientic.

4. The Non-Rechargeable Stimulator must be returned to Boston Scientic (or a Boston Scientic

authorized agent) within 30 days after it fails to function within normal ranges. That Non-

Rechargeable Stimulator will be the property of Boston Scientic.

5. The limited warranty does not include failures to function within normal ranges caused by:

(a). Fire, oods, lightning, natural disasters, water damage, and other calamities commonly

dened as “Acts of God”;

(b). Accident, misuse, abuse, negligence, or the customer’s failure to operate the Non-

Rechargeable Stimulator in accordance with manufacturer’s instructions;

(c). Unauthorized attempts to repair, maintain, or modify the Non-Rechargeable Stimulator for

the patient or any unauthorized third party; or

(d). Attaching equipment to the Non-Rechargeable Stimulator that is not supplied or expressly

authorized by Boston Scientic.

Vercise™ PC Information for Prescribers

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This limited warranty is the only warranty that applies to the Non-Rechargeable Stimulator, and

Boston Scientic expressly disclaims any other warranty, express or implied, including any warranty

of merchantability or tness for a particular purpose. Under this limited warranty, Boston Scientic

will be responsible only for replacement of the Non-Rechargeable Stimulator with a functionally

equivalent Non-Rechargeable Stimulator made by Boston Scientic and will not be liable for any

damages (whether direct, indirect, consequential,or incidental) caused by the Non-Rechargeable

Stimulator, whether the claim is based on warranty, contract, tort or any other theory.

Boston Scientic assumes no liability with respect to instruments reused, reprocessed

or resterilized and makes no warranties, express or implied, including but not limited to

merchantability or tness for a particular purpose, with respect to such instruments.

Limited Warranty - Leads

Boston Scientic Corporation (referred to as Boston Scientic) warrants to the patient that the DBS

Leads, Lead Extensions, and Lead Boots are free from defects in workmanship and materials for a

period of one (1) year from the date of implantation.

A Lead, Extension, or Boot that fails to function within normal tolerances within (1) year from the

date of surgery is covered under this Limited Warranty. The liability of Boston Scientic under this

warranty shall be limited to: (a) replacement with a functionally equivalent Lead, Extension, or Boot;

or (b) full credit equal to the original purchase price to be applied towards the purchase of a new

Lead, Extension, or Boot. Product claims under Boston Scientic Limited Warranty are subject to

the following conditions and limitations:

1. The product registration card must be completed and returned to Boston Scientic within 30

days of surgery in order to obtain warranty rights.

2. The Lead, Extension, or Boot must be returned to Boston Scientic (or authorized agent) within

30 days of malfunction or discovery of defect, and shall be the property of Boston Scientic.

3. The Lead, Extension, or Boot must be implanted prior to the “use by” date.

4. Failure of the Lead, Extension, or Boot must be conrmed by Boston Scientic. This warranty

specically excludes defects or malfunctions caused by: (a) re, oods, lightning, natural

disasters, water damage, and other calamities commonly dened as “Acts of God”; (b)

accident, misuse, abuse, negligence, or the customer’s failure to operate the Lead, Extension,

and Boot 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 Boston Scientic without prior approval.

(a). This warranty does not include surgical accessories used with the Lead, Extension, or

Boot.

5. The decision as to product replacement or credit shall be made solely at the discretion of

Boston Scientic. For a replacement Lead, Extension, or Boot, the warranty will run only to the

end of the warranty period for the original Lead, Extension, or Boot that was replaced.

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

of merchantability or tness for intended use. Except as expressly provided by this Limited

Warranty, Boston Scientic shall not be responsible or liable for any direct, consequential

or incidental damages caused by device malfunction, failure or defect, whether the claim is

based on warranty, contract, tort, or otherwise.

Limited Warranty - Externals

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en

Boston Scientic assumes no liability with respect to instruments reused, reprocessed

or resterilized and makes no warranties, express or implied, including but not limited to

merchantability or tness for a particular purpose, with respect to such instruments.

Limited Warranty - Externals

Boston Scientic Corporation (referred to as Boston Scientic) warrants to the patient that the

Remote Control device and Charging System (Charger and/or Charger Base Station) are free from

defects in workmanship and materials for a period of one (1) year from the date of purchase.

If a Remote Control Device or Charging System component fails to function within normal ranges

within one year after the date of purchase, Boston Scientic will replace the device or component

with a functionally equivalent device or component made by Boston Scientic. No other relief

whatsoever is available under this limited warranty. The limited warranty for a replacement device

or component will last only for one year after the date of purchase. Claims under this limited

warranty are subject to the following additional conditions and limitations:

1. The product registration card must be completed and returned to Boston Scientic within 30

days of purchase.

2. Boston Scientic must conrm the device or component failure.

3. The device or component must be returned to Boston Scientic (or Boston Scientic’s

authorized agent) within 30 days after it fails to function within normal ranges. That device or

component will be Boston Scientic’s property.

4. This limited warranty does not include failures to function within normal ranges caused by:

(a). re, oods, lightning, natural disasters, water damage, and other calamities commonly

dened as “Acts of God”;

(b). accident, misuse, abuse, negligence, or the customer’s failure to operate the device or

component in accordance with manufacturer’s instructions;

(c). unauthorized attempts to repair, maintain, or modify the device or component by the

patient or any unauthorized third party; or

(d). attaching equipment to the device or component that is not supplied or expressly

authorized by Boston Scientic.

This limited warranty is the only warranty that applies to the device or component, and

Boston Scientic expressly disclaims any other warranty, express or implied, including any

warranty of merchantability or tness for a particular purpose.

Vercise™ PC Information for Prescribers

92190993-02 16 of 459

en

Under this limited warranty, Boston Scientic will be responsible only for replacement of the device

or component with a functionally equivalent device or component made by Boston Scientic and

will not be liable for any damages (whether direct, indirect, consequential, or incidental) caused

by the device or component, whether the claim is based on warranty, contract, tort, or any other

theory.

The following is federal government communications regulation information about the Vercise PC

DBS System.

This device complies with part 15 of the FCC Rules. Operation is subject to the following two

conditions: (1) This device may not cause harmful interference, and (2) This device must accept

any interference received including interference that may cause undesired operation.

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