Vercise™ Deep Brain Stimulation Systems Information for Prescribers CAUTION: Federal law restricts this device to sale, distribution and use by or on the order of a physician.
Vercise™ Deep Brain Stimulation Systems Information for Prescribers How to Use this Manual This manual provides information about the Boston Scientific Deep Brain Stimulation (DBS) System. Throughout this manual, the name “Boston Scientific DBS System” refers to the following Systems: Vercise GenusTM, Vercise GeviaTM, and VerciseTM PC. Read all instructions carefully before using the DBS System.
Table of Contents Device Description........................................................................................... 1 Intended Use / Indications for Use........................................................................... 1 Safety Information............................................................................................ 2 Contraindications..................................................................................................... 2 Warnings.......................
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Device Description Device Description The Boston Scientific Deep Brain Stimulation (DBS) System provides a reversible therapy where structures in the brain are stimulated with small electrical pulses. A Boston Scientific DBS System utilizes current steering (also known as multiple independent current control or MICC) across eight or sixteen Contacts per DBS Lead to provide precise positioning of stimulation.
Vercise™ Deep Brain Stimulation Systems Information for Prescribers Safety Information Contraindications The Boston Scientific DBS System, or any of its components, is contraindicated for the following: Diathermy: Shortwave, microwave, and/or therapeutic ultrasound diathermy should not be used on patients implanted with the Boston Scientific DBS System, or any of the system components.
Safety Information Warnings Automobiles and Equipment: Patients should operate automobiles, other motorized vehicles, or potentially dangerous machinery/equipment with caution after receiving the Boston Scientific DBS System. Patients should avoid performing activities that would be dangerous if treated symptoms were to return, or in which stimulation changes could occur. Charge Density: High levels of stimulation may damage brain tissue.
Vercise™ Deep Brain Stimulation Systems Information for Prescribers • For DBS devices using Bluetooth technology for communication, other sources of electromagnetic disturbance, such as Wi‑Fi routers, cordless phones, Bluetooth wireless streaming devices, baby monitors, and microwave ovens.
Safety Information Suicide: New onset or worsening depression which may be temporary or permanent is a risk that has been reported with DBS therapy. Suicidal ideation, suicide attempts, and suicide are events that have also been reported. Therefore, physicians should consider the following: • Preoperatively, assess patients for the risks of depression and suicide.
Vercise™ Deep Brain Stimulation Systems Information for Prescribers Precautions Physician training is required for usage of the Boston Scientific 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.
Safety Information Device Failure: Implants can fail at any time due to random component failure, loss of battery functionality, or DBS Lead breakage. Stopping brain stimulation suddenly can cause serious reactions to develop. If the Stimulator stops working, patients should be instructed to turn off the Stimulator and contact their healthcare provider immediately so that the system can be evaluated and appropriate medical care can be given to manage the return of symptoms.
Vercise™ Deep Brain Stimulation Systems Information for Prescribers 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. If any of the procedures below is required by medical necessity, the procedure(s) should be performed as far from the implanted components as possible. Stimulator function should be confirmed after the procedure.
Safety Information Operating Temperature: The operating temperature of the External Trial Stimulator, Remote Control, and Programming Wand is 5 °C to 40 °C (41 °F to 104 °F). For proper operation, do not use the Charging System if the ambient temperature is above 35 °C (95 °F). Other Models of External Devices: Only the Remote Control, Charging System (as applicable), and Clinician Programmer that were provided with the Boston Scientific DBS System should be used with the Boston Scientific DBS System.
Vercise™ Deep Brain Stimulation Systems Information for Prescribers 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 the appearance of the skin at the Stimulator location, such as the skin becoming thin over time, they should contact their healthcare provider.
Safety Information Storage, Handling, and Transport: Store implanted components, such as the Stimulator, Leads, and Lead 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 Scientific.
Vercise™ Deep Brain Stimulation Systems Information for Prescribers Adverse Events The following is a list of known risks with the use of deep brain stimulation. There may be risks that are unknown. 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 healthcare provider as soon as possible.
Safety Information • • • • • • • • • • • • Pain, headache or discomfort Pneumonia from difficulty with swallowing or from inhaling fluid Psychiatric disturbances such as anxiety, depression, lessened interest or emotion, hypersexuality, aggression, mania or hypomania, psychosis, emotional sensitivity, sleep problems, suicide, or suicidal thoughts or attempts Seizures Sensory changes Speech or language problems Swallowing difficulty Systemic effects such as rapid heart beat, sweating, fever, dizziness, ch
Vercise™ Deep Brain Stimulation Systems Information for Prescribers Service and Maintenance External Trial Stimulator (ETS) Maintenance The ETS may be used to conduct intraoperative stimulation testing during the Lead implantation procedure. Refer to the DFU listed in your DBS Reference Guide for detailed procedure and guidelines for intraoperative testing. 1. Left Connector 2. Right Connector 3. Stimulator Light 4. Stimulation ON/OFF 5. Battery Indicator Light Figure 1.
Service and Maintenance Cleaning the Charging System The components of the Charging System (Charger, Base Station, and Power Supply) 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. Hand wash the Charging Belt or Charging Collar with mild soap and warm water.
Vercise™ Deep Brain Stimulation Systems Information for Prescribers Electromagnetic Compatibility EN 60601‑1‑2 Classification Information • Internally Powered Equipment • Continuous Operation • Ordinary Equipment • Class II Table 1: Guidance and Manufacturer’s Declaration Electromagnetic Emissions The Boston Scientific DBS System is intended for use in electromagnetic environment specified below.
Electromagnetic Compatibility Table 2: Guidance and Manufacturer’s Declaration Electromagnetic Immunity The Boston Scientific DBS System is intended for use in the electromagnetic environment specified below. The customer or the user of the Boston Scientific DBS System should assure that it is used in such an environment.
Vercise™ Deep Brain Stimulation Systems Information for Prescribers Table 2 (Continued): Guidance and Manufacturer’s Declaration Electromagnetic Immunity Immunity Test Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000‑4‑11 (Programming Wand only) Power frequency (50/60 Hz) magnetic field IEC 61000‑4‑8 IEC 60601‑1‑2 Test Level Compliance Level <5 % UT <5 % UT (>95 % dip in UT) (>95 % dip in UT ) for 0,5 cycle for 0,5 cycle 40 % UT 40 % UT (60 % dip in
Electromagnetic Compatibility Table 3: Guidance and Manufacturer’s Declaration Electromagnetic Immunity The Boston Scientific DBS System is intended for use in the electromagnetic environment specified below. The customer or the user of the Boston Scientific DBS System should assure that it is used in such an environment.
Vercise™ Deep Brain Stimulation Systems Information for Prescribers Table 4: Immunity Testing RFID Readers The external electrical components of the Boston Scientific DBS System have been tested for immunity to interference from RFID readers per the following specifications. RFID Spec Per AIM 7351731 Frequency Test Level (RMS) ISO 14223 134.2 kHz 65 A/m ISO/IEC 14443‑3 (Type A) 13.56 MHz 7.5 A/m ISO/IEC 14443‑4 (Type B) 13.56 MHz 7.5 A/m ISOAEC 15693 (ISO 18000‑3 Mode 1) 13.
Electromagnetic Compatibility Table 5: Manufacturer’s Declaration Proximity Fields The Boston Scientific DBS System is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
Vercise™ Deep Brain Stimulation Systems Information for Prescribers Essential Performance External Trial Stimulator The stimulation pulse shall meet the requirements for charge balance and amplitude while stimulation is on. Other External Devices Failure of the external electrical components will not result in an unacceptable risk to the user.
Electromagnetic Compatibility Quality of Wireless Service Vercise PC and Vercise Gevia DBS Systems The Vercise PC and Vercise Gevia DBS Systems use a Half‑Duplex, direct point‑to‑point, primary‑secondary communication system with the characteristics listed in Table 6: Table 6: Quality of Wireless Service of the Configure Tab (Vercise PC and Vercise Gevia) Boston Scientific Stimulator Type Typical Range Between the Remote Control and Stimulator Between the Wand and Stimulator Non‑Rechargeable Stimulator
Vercise™ Deep Brain Stimulation Systems Information for Prescribers Troubleshooting Wireless Coexistence Issues Other wireless and RF technology based equipment operating in close proximity to a similar frequency band may degrade the range and responsiveness of the Boston Scientific DBS System.
Electromagnetic Compatibility Wireless Security Vercise PC and Vercise Gevia DBS Systems The Vercise PC and Vercise Gevia DBS Systems have a short range inductively coupled telemetry system. A Remote Control (or Wand) has to be linked with a Stimulator to allow communication. The Stimulator will not respond to any unlinked device. There are additional mechanisms that ensure the integrity of the communicated data.
Vercise™ Deep Brain Stimulation Systems Information for Prescribers Clinician Programmer Security The Clinician Programmer (CP) is a hardened computer with the following security controls: • Access to the CP is restricted to authorized users and the CP screen locks out if there is no activity and may only be unlocked with a password to prevent unauthorized access. • The CP Platform enforces a password lockout duration after a predefined number of unsuccessful login attempts.
Electromagnetic Compatibility FCC Compliance The following is federal government communications regulation information about the Boston Scientific 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.
Vercise™ Deep Brain Stimulation Systems Information for Prescribers Rechargeable Stimulator Battery Stimulator Battery The rechargeable Stimulator battery should provide at least five years of service. In many cases, the Stimulator battery should provide at least 15 years of service. Battery life is dependent on the stimulation settings and conditions.
Non‑Rechargeable Stimulator Battery Non‑Rechargeable Stimulator Battery Stimulator Battery The longevity of the non‑rechargeable 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 in your DBS Reference Guide.
Legal Manufacturer Boston Scientific Neuromodulation Corporation 25155 Rye Canyon Loop Valencia, CA 91355 USA (866) 789-5899 in US and Canada (661) 949-4000, (661) 949-4022 Fax (866) 789-6364 TTY www.bostonscientific.com Email: neuro.info@bsci.
