Related Manuals for Boston Scientific Vercise PC Implantable Pulse Generator
Summary of Contents for Boston Scientific Vercise PC Implantable Pulse Generator
- Page 1 Vercise™ PC Implantable Pulse Generator Directions for Use 92104390-01 Content: 92116333 REV B CAUTION: Federal law restricts this device to sale, distribution and use by or on the order of a physician.
- Page 2 Trademarks All trademarks are the property of their respective holders. Guarantees Boston Scientific Corporation reserves the right to modify, without prior notice, information relating to its products in order to improve their reliability or operating capacity. Additional Information For indications, contraindications, warnings, precautions, adverse events summary, physician instructions, sterilization and component disposal, refer to the Information for Prescribers DFU.
- Page 3 In accordance with international practice and regulatory legislation in some countries, a registration form is packed with each Boston Scientific 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 specific implanted DBS Lead, accessory, or device to gain quick access to pertinent data from the manufacturer.
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Page 4: Table Of Contents
Vercise™ PC Implantable Pulse Generator DFU Table of Contents Introduction ....................1 Device Description ....................1 Compatible Leads and Extensions ............... 1 Package Contents ....................1 Stimulator Implantation ................2 Exposing the DBS Lead ..................2 Connecting the DBS Lead to the DBS Extension ..........2 Tunneling the DBS Lead and Extension ............. -
Page 5: Introduction
Control, to communicate with the Stimulator. Compatible Leads and Extensions For a list of leads and extensions compatible with the Vercise PC, please see your DBS Reference Guide. Package Contents Vercise PC Implantable Pulse Generator Kit • Stimulator • Stimulator Template •... -
Page 6: Stimulator Implantation
Vercise™ PC Implantable Pulse Generator DFU Stimulator Implantation Exposing the DBS Lead 1. Palpate the DBS Lead Boot and DBS Lead under the scalp. 2. Mark and create an incision in the scalp to expose the Lead Boot. Be careful not to damage or cut the DBS Lead. - Page 7 Stimulator Implantation 3. Visually check to ensure that the DBS Lead electrodes are aligned with the DBS Extension contacts. If they are not aligned, continue to grip the DBS Lead next to the Retention Sleeve and push to advance the electrodes into alignment with the DBS Extension contacts. If necessary, back out the lead slightly and then advance the electrodes into alignment again, until proper alignment can be confirmed.
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Page 8: Tunneling The Dbs Lead And Extension
1. Create a pocket for the Stimulator under the skin in a location inferior to the clavicle on the same side as the DBS Lead and Extensions. Note: Boston Scientific recommends implanting the Stimulator subclavicularly. a. Mark the location of the pocket. -
Page 9: Connecting The Stimulator
Stimulator Implantation CAUTION: Do not use polypropylene sutures as they may damage the suture sleeve. Do not suture directly onto the DBS Extension or use a hemostat on the DBS Extension body. This may damage the DBS Extension insulation. Connecting the Stimulator Dual Lead Connection Connect Left DBS Extension to port C Connect Right DBS Extension to port D... - Page 10 Vercise™ PC Implantable Pulse Generator DFU 2. Verify that the retention sleeve on the DBS Extension is located directly under the Setscrew in the Stimulator header. Note: The retention sleeve is easily distinguishable from the contacts by its length (see below).
- Page 11 Stimulator Implantation CAUTION: The wrench is torque limiting, such that the Setscrew cannot be over tightened. Use only the wrench provided, as other tools may over-tighten the Setscrew and damage the Lead. 6. Visually check to ensure that the Lead electrodes are aligned with the DBS Extension contacts. If they are not aligned, continue to grip the Lead next to the Retention Sleeve and push to advance the electrodes into alignment with the DBS Extension contacts.
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Page 12: Vercise Pc System Revisions, Replacement, And Explantation
Vercise™ PC Implantable Pulse Generator DFU 10. Repeat steps 1 – 9 to tighten second Stimulator Setscrew and the Setscrew on the second DBS Extension. 11. Place the Stimulator in the subcutaneous pocket. a. Coil the excess DBS Extension length around the Stimulator perimeter. WARNING: Avoid placing the excess DBS Extension length on the superficial surface of the Stimulator, as this may increase the potential for tissue erosion or damage during Stimulator replacement surgery. -
Page 13: Explanting The Dbs Extensions
DBS Reference Guide. If you are explanting the entire Vercise PC System, continue on to the Explanting the DBS Extensions procedure. Otherwise, close the incisions. 13. Ship the explanted DBS Leads to Boston Scientific. Explanting the DBS Extensions 1. -
Page 14: Explanting Or Replacing The Stimulator
DBS Extensions, attach Lead Boots, and coil the excess DBS Extension material in the pocket. 9. Close the incision. 10. Ship the explanted Stimulator to Boston Scientific. CAUTION: Be careful not to damage any remaining implanted components when closing the incision. -
Page 15: Physical Characteristics Of The Vercise Pc Stimulator
Physical Characteristics of the Vercise PC Stimulator Physical Characteristics of the Vercise PC Stimulator The physical characteristics of the Stimulator are outlined in Table 1. The Stimulator contains a radiopaque identification tag. The identification tag is visible using standard x-ray procedures. Table 1: Stimulator Physical Properties Feature Description... - Page 16 Vercise™ PC Implantable Pulse Generator DFU Table 2: Stimulator Function Parameter Range Charge balanced, Waveform asymmetric biphasic Pulse Shape Rectangular Current or Voltage Regulated Current Amplitude 0.1 – 20 mA Rate 2 – 255 Hz Pulse Width 20 – 450 µs Cycle (On/Off) 1 s –...
- Page 17 Stimulator Programmable Characteristics Stimulation Output at Maximum Parameters vs. Impedance. The above graphs show the maximum output current when stimulation settings are set to the maximum values on a Ring or Directional electrode (Amplitude Max = 12.7 mA, PW = Various shown (450, 240, 120, 30 µs), Rate Max = 255 Hz).
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Page 18: Dbs Extension
Vercise™ PC Implantable Pulse Generator DFU DBS Extension The DBS Extension consists of a connector at the distal end and 8 cylindrical contacts at the proximal end. The DBS Lead may be inserted and secured into the connector, which also contains 8 contacts that align with the contacts on the DBS Lead to form electrical connections. - Page 19 This page intentionally left blank. Vercise™ PC Implantable Pulse Generator DFU 92104390-01 15 of 15...
- Page 20 Australian Sponsor EU Authorized Legal Manufacturer Address Representative Boston Scientific Neuromodulation Boston Scientific (Australia) Pty Ltd Boston Scientific Limited Corporation PO Box 332 Ballybrit Business Park 25155 Rye Canyon Loop BOTANY Galway, Ireland Valencia, CA 91355 USA NSW 1455 T: +33 (0) 1 39 30 97 00...