Precision Spectra™ System Implantable Pulse Generator Directions for Use SC-1132 Implantable Pulse Generator CAUTION: Federal law restricts this device to sale, distribution and use by or on the order of a physician.
Implantable Pulse Generator Copyright © 2011 Boston Scientific Corporation or its affiliates. All Rights Reserved. These documents are the property of Boston Scientific Corporation and shall not be reproduced, distributed, disclosed, or used for manufacture or sale of device without the express written consent of Boston Scientific Corporation.
Table of Contents Table of Contents Description ...................................................................................................................... 1 Package Contents .......................................................................................................... 1 IPG Kit ......................................................................................................................... 1 Specifications and Technical Data...................................................
Implantable Pulse Generator This page intentionally left blank.
Description Description The Precision Spectra™ Implantable Pulse Generator (IPG) 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.
Implantable Pulse Generator 90655621-03 Rev A 2 of 11 Current (mA) Impedance (Ω) Note: Maximum output capacity is frequency independent Programmable up to 12.7 mA Programmable up to 15.8 mA Programmable up to 21.1 mA Programmable up to 25.
Specifications and Technical Data Specifications and Technical Data Parameter Range Default Areas (Channels) 4 — Amplitude 0 – 25.5 mA Rate 2 – 1200 pps Width 20 – 1000 μsecb 210 μsec Cycle 0.1 – 90 min, OFF OFF Ramp ON 1 – 10 secs 3 secs Contacts 1 – 32, case: +100% to -100%, OFF 1 – 32, case: OFF 0 mA a 40 pps a. Only one Area is available if the rate is ≥130 pps. b. Amplitude × Width ≤ 12.7 μC. Materials Case Titanium Header Epoxy Strain Relief Silicone Size/Volume 55.
Implantable Pulse Generator Instructions for Use IPG Handling and Storage • • • • • Handle the IPG and all components with care. Keep sharp instruments away from the components. Do not use the IPG if it has been dropped on a hard surface. 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 Boston Scientific Neuromodulation. An explant kit is available.
Instructions for Use Note: Using the IPG 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. Select an IPG site several inches away from the previously externalized trial lead site to reduce risk of infection. Tunneling the Lead or Lead Extension 1. If not already assembled, attach the tunneling tool handle to the shaft by turning the locking mechanism clockwise. Tool Handle Locking Mechanism Shaft 2.
Implantable Pulse Generator 5. Make a small incision at the desired exit site. 6. Create a subcutaneous tunnel between the lead(s) incision and the IPG pocket site until the straw is visible and accessible at the exit point. 7. Unscrew and remove the tunneling tool handle. 8. Grasp the tip of the tool with one hand while holding the straw in place with the other hand. Pull the tunneling tool shaft out through the straw. 9. Push the lead or extension through the straw, then withdraw the straw. 10.
Instructions for Use CAUTION: Do not tunnel splitter. Note: If using the 2x8 Splitter and performing a permanent trial, the splitter tails may be tunneled to the exit site. Note: The following Codman Disposable Catheter Passers may be used in place of the Boston Scientific tunneling tool: REF 82-1515 (36 cm); REF 82-1516 (55 cm); REF 82-1517 (65 cm) Note: When using a Codman Disposable Catheter Passer, tunnel from the midline incision to the IPG pocket using the standard technique.
Implantable Pulse Generator 1. Fully insert the lead(s), extension(s), splitter(s), and/or connector(s) into the IPG port(s), being careful not to stress or bend the proximal end of the lead. When the lead is properly inserted, the lead will stop and the retention ring will be located under the set screw. 2. Fully insert a port plug into unused IPG ports.
Rechargeable Stimulator System 6. If desired, secure the IPG in the pocket by suturing through the holes in the IPG header. CAUTION: Do not suture through leads or splitter. 7. Close and dress the wound(s). IPG Explant or Replacement 1. Turn off the IPG. 2. Surgically open the IPG pocket and withdraw the device. Please try to preserve the integrity of all components so that complete device assessment can be performed. 3.
Implantable Pulse Generator Charging Steps WARNINGS: • • • Patient 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 Charger Belt or an adhesive patch, as shown, may result in a burn. If pain or discomfort is felt, cease charging and contact Boston Scientific. The Charger Base Station should be plugged in and the Charger placed in the Base Station when not in use.
IPG Battery Status Note: If you accidentally locate the patch in the wrong place, or if the Charger Belt moves out of alignment, the Charger will start beeping again. Use a new adhesive patch or readjust the belt to place the Charger back into position. 5. When the Charger emits a series of double beeps, the Stimulator is fully charged. Turn off the Charger, remove the Charger Belt or adhesive patch, and return the Charger to the Base Station.
Corporate Headquarters Boston Scientific Neuromodulation 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.com AUS Australian Sponsor Address Boston Scientific (Australia) Pty Ltd PO Box 332 BOTANY NSW 1455 Australia Free Phone 1800 676 133 Free Fax 1800 836 666 EU Authorised Representative: Boston Scientific International S.A.
