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Summary of Contents for Boston Scientific Precision
- Page 1 Precision™ Spinal Cord Stimulator System Clinician Manual Directions for Use 97035873-01 CAUTION: Federal law restricts this device to sale, Content: MP97035873-01 REV B distribution and use by or on the order of a physician.
- Page 2 Precision™ Spinal Cord Stimulator System Clinician Manual 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. Drawings are for illustration purposes only. Trademarks All trademarks are the property of their respective holders.
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Page 3: Table Of Contents
Device and Product Description ....................2 Implantable Pulse Generator ......................2 Leads ...............................2 Lead Extension ..........................3 Lead Splitter ............................3 Indications for Use ........................4 Precision System Clinical Summary ....................4 Safety Information .......................... 9 Instructions for the Patient ........................9 Warnings ............................9 Precautions ............................10 Adverse Effects ..........................11 Instructions for the Physician ......................12... - Page 4 Precision™ Spinal Cord Stimulator System Clinician Manual Securing the Infinion CX Trial Lead ................... 32 Permanent Lead Anchoring and Tunneling ................33 Anchoring the Lead ........................34 Tunneling the Lead or Lead Extension ..................35 Connecting the Lead Extension .....................37 Connecting to the Trial Stimulator ..................... 39 Removal of Trial Leads, Extensions, and Splitters ..............
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Page 5: Manual Overview
Manual Overview Manual Overview This manual provides basic information for the trial, implantation, and operation of the Boston Scientific Precision Spinal Cord Stimulator (SCS) system. General surgical guidelines are presented in this manual for temporary and permanent implantation of Boston Scientific percutaneous leads, lead extensions, splitters, surgical paddle leads, and implantable pulse generator (IPG). -
Page 6: Device And Product Description
Each contact is 3 mm in length and is spaced 1 mm from the adjacent contact. The Infinion 16 lead must be inserted into a Splitter 2x8 which then connects to a Precision IPG’s 8 contact ports or 8 contact OR Cables. -
Page 7: Lead Extension
Device and Product Description Lead Extension Lead Extensions are designed to connect the percutaneous and paddle leads to the Precision IPG for spinal cord stimulation. The extension may be added to a lead to externalize the lead for a trial procedure or to extend the lead when a permanent IPG is implanted. -
Page 8: Indications For Use
Precision™ Spinal Cord Stimulator System Clinician Manual Indications for Use The Boston Scientific Precision Spinal Cord Stimulator (SCS) System is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs including unilateral or bilateral pain associated with the following: •... - Page 9 Eleven studies were identified based on the detailed inclusion/exclusion criteria to demonstrate the safety of the PRECISION System. The studies included a total of 1056 patients that were trialed with SCS systems and 880 patients that received implants. The table below depicts the number of patients, the number of events, and the percentage of occurrences of each event compared to the total number of patients.
- Page 10 5.1% Clinical Experience-Safety Clinical data has been collected during a clinical study of the PRECISION System. As of January 15, 2004, 35 subjects were enrolled in the study at multiple sites and 26 subjects had a successful trial stimulation period and were implanted with the PRECISION System.
- Page 11 Neurosurgery, 46:399-406, 2000. Subperception Therapy – Clinical Summary Determination of the safety and effectiveness of the Boston Scientific Spinal Cord Stimulator (SCS) Systems for subperception therapy was based on a prospective, randomized, multicenter, crossover study with the primary endpoint of responder rate (proportion of subjects with 50% or greater improvement in overall pain) at 3 month post-device activation.
- Page 12 Precision™ Spinal Cord Stimulator System Clinician Manual At the end of the crossover period, subjects were asked to choose between supra-perception and subperception settings. Of the 70 subjects included in the primary effectivenss cohort, 53 subjects (76%) chose subperception whereas only 17 (24%) chose supra-perception as their preferred treatment settings.
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Page 13: Safety Information
If you experience pain or discomfort, cease charging and contact Boston Scientific. Magnetic Resonance Imaging (MRI). Patients implanted with the Precision 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”... -
Page 14: Precautions
Precision™ Spinal Cord Stimulator System Clinician Manual • Other sources of electromagnetic disturbance, such as RF transmitters at television or radio broadcast stations, Amateur Radio or Citizens Band radio transceivers, or Family Radio Service band transceivers. Note: When in close proximity, equipment that generates strong electromagnetic fields might cause unintended stimulation or interfere with wireless communication even if they comply with International Special Committee on Radio Interference (CISPR) requirements. -
Page 15: Adverse Effects
Dispose of used batteries in accordance with local regulations. The IPG should be explanted in the case of cremation, and returned to Boston Scientific. External devices to be disposed of per local regulatory requirements. Please contact your healthcare professional. -
Page 16: Instructions For The Physician
Precision™ Spinal Cord Stimulator System Clinician Manual • 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 deficit, including paralysis. -
Page 17: Essential Performance
Safety Information Medical Devices/Therapies. If the patient is required to undergo lithotripsy, electrocautery, external defibrillation, radiation therapy, ultrasonic scanning, or high-output ultrasound: • Turn off stimulation at least five minutes before the procedure or application. • All equipment, including ground plates and paddles, must be used as far away from the IPG as possible. -
Page 18: Package Contents
Precision™ Spinal Cord Stimulator System Clinician Manual Package Contents IPG Kit (1) Precision Implantable Pulse Generator (1) Hex Wrench (1) Tunneling Tool Assembly (1) IPG Pocket Template (2) Port Plugs (1) Device Registration Form/Temporary Patient Identification Card (1) Manual Percutaneous Permanent Lead Kit... -
Page 19: 2X4 Splitter Kit
Package Contents 2x4 Splitter Kit (1) Splitter (1) Hex wrench (1) Manual and Insert (1) Device Registration Form/Temporary Patient Identification Card Surgical Paddle Lead Kit (1) Paddle Lead (4) Suture Sleeves (2) OR Cable Assemblies (2) Lead Position Labels—left and right (non-sterile) (1) Device Registration Form/Temporary Patient Identification Card (1) Manual Infinion 16 Lead Kit... -
Page 20: Infinion Cx Lead Trial Lead Kit
Precision™ Spinal Cord Stimulator System Clinician Manual Infinion CX Lead Trial Lead Kit (1) 16 Contact Percutaneous Infinion CX Lead with pre-loaded Curved Stylet (2) Suture Sleeves (2) Lead Position Labels—left and right (non-sterile) (1) Manual (1) Product Registration Form/Temporary Patient Identification Card... -
Page 21: Sterilization, Handling, And Storage
Do not use any component that shows signs of damage. • Do not resterilize the package or the contents. Obtain a sterile package from Boston Scientific. • Do not use the product if the labeled “Use By” date has passed. -
Page 22: Lead, Lead Extension, And Splitter Handling And Storage
Precision™ Spinal Cord Stimulator System Clinician Manual Lead, Lead Extension, and Splitter Handling and Storage • Avoid damaging the lead with sharp instruments or excessive force during surgery. • Do not sharply bend or kink the lead, extension, or splitter. -
Page 23: Pre-Op Instructions
Pre-Op Instructions Pre-Op Instructions 1. Ensure that the IPG is fully charged prior to the permanent implant procedure. The approximate location of the IPG is marked on the IPG kit. Turn on the Charger and place it over the IPG to begin charging. 2. -
Page 24: Percutaneous Lead Placement In The Epidural Space
45° or less. CAUTION: Use only an insertion needle provided by Boston Scientific. Other needles may damage the lead. The stamped number “14” on the needle hub (or the triangle on the hub of the curved Epimed needle, sold separately) corresponds to the orientation of the bevel, which must face up. -
Page 25: Infinion Cx Lead Placement In The Epidural Space With Entrada™ Needle
Percutaneous Lead Placement in the Epidural Space WARNING: If the lead stylet is removed and reinserted, do not use excessive force when inserting the stylet into the lead. The use of instruments, such as forceps, to grasp the stylet during insertion is not recommended as this could result in applying excessive force and could increase the risk of lead and tissue damage. - Page 26 Precision™ Spinal Cord Stimulator System Clinician Manual Fully Assembled Entrada Needle Components Components are marked with dots to indicate use order, and the dots should be in the same direction when assembling the needle. Needle Stylet, • Loss of Resistance (LOR) adaptor, ••...
- Page 27 45° or less. CAUTION: Use only an Entrada Needle provided by Boston Scientific. Other needles may damage the lead. Turning the bevel ventral (down) may result in lead damage. An angle of more than 45° increases the risk of lead damage.
- Page 28 Precision™ Spinal Cord Stimulator System Clinician Manual 5. Remove the needle stylet from the insertion needle and verify entry into the epidural space using the standard technique. Remove needle stylet Verify entry into the epidural space. 6. OPTIONAL. Under fluoroscopic guidance, insert the lead blank through the LOR adaptor and into the epidural space.
- Page 29 Percutaneous Lead Placement in the Epidural Space 8. While holding the lead stylet handle, place the steering cap over the proximal end of the stylet handle with moderate force until it is held in place. The lead stylet should be fully inserted into the lead. Slowly insert the Infinion CX Lead into the slotted needle, directing the distal lead tip into the needle lumen.
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Page 30: Lead Connection To Splitter
Precision™ Spinal Cord Stimulator System Clinician Manual Lead Connection to Splitter 1. Carefully withdraw the stylets from the leads to be inserted into the splitter. 2. Wipe clean the proximal connector ends of the leads. 3. Select the desired splitter model. - Page 31 Medical Adhesive Silicone, Type A - Sterile, as ® available from Boston Scientific, part number SC-4320) to coat and seal the top of the seal plug that has been penetrated by the hex wrench. Note: Inadvertent damage to the septum seal may lead to unintended stimulation at the Splitter 2x8 if the Medical Adhesive is not used as intended.
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Page 32: Surgical Paddle Lead Placement In The Epidural Space
Precision™ Spinal Cord Stimulator System Clinician Manual Surgical Paddle Lead Placement in the Epidural Space 1. Determine the appropriate vertebral level for lead placement using fluoroscopic guidance. 2. Position, prep and drape the patient in the usual accepted manner. 3. OPTIONAL Prior to introduction of the Paddle Lead into the epidural space, a Passing Elevator may be used. -
Page 33: Connecting The Or Cable Assembly
Connecting the OR Cable Assembly Connecting the OR Cable Assembly The OR cable assembly is designed for temporary connection of a lead to the Trial Stimulator. A cable extension is provided. When using a Splitter 2x8 prepare two OR Cable Assemblies. CAUTION: Do not immerse the OR cable connector or plug in water or other liquids. -
Page 34: Intraoperative Stimulation Testing
Precision™ Spinal Cord Stimulator System Clinician Manual Intraoperative Stimulation Testing Note: The following steps are for procedural reference only. Please refer to the BionicNavigator Software Guide for detailed stimulation testing procedures and guidelines. 1. If using a splitter: • Visually check splitter to leads connection •... -
Page 35: Securing The Trial Lead
Securing the Trial Lead Securing the Trial Lead Note: If using an Infinion CX lead, proceed to “Securing the Infinion CX Trial Lead” on page 32. 1. Carefully withdraw the insertion needle from the epidural space by slowly pulling the needle up towards the proximal end of the lead while holding the lead in place. -
Page 36: Securing The Infinion Cx Trial Lead
Precision™ Spinal Cord Stimulator System Clinician Manual Securing the Infinion CX Trial Lead 1. Carefully withdraw the slotted needle by slowly pulling the needle towards the proximal end of the lad while stabilizing lead in line with the slot to keep lead in place. -
Page 37: Permanent Lead Anchoring And Tunneling
Permanent Lead Anchoring and Tunneling Permanent Lead Anchoring and Tunneling Removing the Insertion Needle Note: If using an Entrada Needle, proceed to “Removing the Entrada Needle”” 1. Cut down around the insertion needle to provide access for anchoring the lead. 2. -
Page 38: Anchoring The Lead
Infinion CX Lead into the Entrada Needle. For the Infinion CX Lead, the stylet may be in place within the lead when the anchor is loaded on the lead. Refer to the Directions for Use for your Boston Scientific anchor, or continue with the following steps to anchor using a suture sleeve. -
Page 39: Tunneling The Lead Or Lead Extension
Permanent Lead Anchoring and Tunneling 6. For Permanent Trials, proceed to the instructions for “Tunneling the Lead or Lead Extension” on page 7. For Permanent IPG Implantation, proceed to the instructions for “IPG Implantation” on page 42. Tunneling the Lead or Lead Extension Note: If tunneling an Infinion CX Lead, it is recommended to use the Long Tunneling Tool (35cm). - Page 40 Precision™ Spinal Cord Stimulator System Clinician Manual 5. Make a small incision at the desired exit site. 6. Create a subcutaneous tunnel between the midline incision and the exit site until the straw is visible and accessible at the exit point.
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Page 41: Connecting The Lead Extension
13. For Permanent IPG Implantation, proceed to the instructions for “Connecting to the IPG” on page 43. Note: The following Codman Disposable Catheter Passers may be used in place of the Boston Scientific tunneling tool except for the Infinion CX Lead:... - Page 42 Precision™ Spinal Cord Stimulator System Clinician Manual 5. Place a small loop at the lead for slack. If necessary, loosely tie a suture around the lead-loop, but do not tighten onto the lead. CAUTION: Tightening sutures directly on the lead can damage the lead.
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Page 43: Connecting To The Trial Stimulator
Connecting to the Trial Stimulator Connecting to the Trial Stimulator Caution • Keep the Trial Stimulator dry. It should not be exposed to moisture. • Do not connect the Trial Stimulator to any other device except to the OR Cables provided with it. •... - Page 44 Precision™ Spinal Cord Stimulator System Clinician Manual Trial Stimulator Battery Service Life The External Trial Stimulator battery has a typical service life of 10 days. Clinician Manual 97035873-01 40 of 75...
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Page 45: Removal Of Trial Leads, Extensions, And Splitters
Removal of Trial Leads, Extensions, and Splitters Removal of Trial Leads, Extensions, and Splitters Remove bandages and properly cleanse the exit site. The method of removal depends upon whether a temporary trial or permanent trial was performed. Option A: Percutaneous Lead Removal after Temporary Trial 1. -
Page 46: Ipg Implantation
Precision™ Spinal Cord Stimulator System Clinician Manual IPG Implantation 1. Ensure that the area surrounding the lead entry site is incised to a dimension that will accommodate the tunneling tool. Check that the lead is securely anchored with the suture sleeve. -
Page 47: Connecting To The Ipg
Connecting to the IPG Connecting to the IPG For Percutaneous Lead - Dual Lead Connection • Superior (upper or left) leads, extensions, or 2x4 Splitters connect to IPG port “1-L”. • Inferior (lower or right) leads, extensions, or 2x4 Splitters connect to IPG port “2-R”. For Infinion™... - Page 48 Precision™ Spinal Cord Stimulator System Clinician Manual 1. Fully insert the lead(s), extension(s), or splitters into the IPG port(s), being careful not to stress or bend the proximal end of the lead or extension. When the lead is properly inserted, the lead will stop and the retention ring will be located under the setscrew.
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Page 49: Programming With The Infinion 16 Lead And Infinion Cx Lead
For detailed programming instructions, refer to the appropriate Bionic Navigator Software Guide. When the Infinion 16 lead is used with the Splitter 2x8 and placed properly into the Precision IPG ports (laser-marked tail of Splitter 2x8 connecting to IPG port “1-L”), the distal 8 contacts of the Infinion 16 lead (contacts 1-8) will correspond with contacts 1-8 on the left side of the Bionic Navigator software display. -
Page 50: Ipg Explant Or Replacement
4. For replacement, connect the new IPG following the instructions for “Connecting to the IPG” 39. Or, to terminate therapy, surgically remove the implanted lead system. 5. Notify Boston Scientific to document the reason for explant or replacement and to arrange for return of IPG and components. -
Page 51: Rechargeable Stimulator System
Rechargeable Stimulator System Rechargeable Stimulator System The Precision Stimulator is rechargeable. Battery life is dependent on your stimulation settings and conditions. Depending on stimulation power usage and programming, the majority of patients will need to recharge the Stimulator between once per week and once per month. High power users will require more frequent charging. -
Page 52: Charging Steps
Failure to use the Charger with either the Charging 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. - Page 53 Rechargeable Stimulator System 4. Secure the Charger over the Stimulator by using either an adhesive patch or the Charging Belt. • Adhesive Patch: Remove the clear liner from the patch. Apply the white side with the blue stripe to the back of the Charger. Then remove the beige liner from the patch. Secure the Charger over the Stimulator by pressing the adhesive to the skin over the Stimulator (see diagram below).
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Page 54: Patient Remote Control
Precision™ Spinal Cord Stimulator System Clinician Manual Charger Battery Service Life The charger battery has a typical service life of 500 charging cycles. Patient Remote Control Caution • Keep the RC dry. It should not be exposed to moisture. •... - Page 55 Rechargeable Stimulator System Signal Strength The Remote Control indicates the communication signal strength between itself and the Stimulator in the upper right corner of the display. For BEST communication, your Remote Control should face the Stimulator. • If there are no signal bars, communication may still be achieved at a very weak level. Move the Remote Control closer to the Stimulator and/or reorient its position to improve communication.
- Page 56 Precision™ Spinal Cord Stimulator System Clinician Manual Stimulation Amplitude The Level screen is the Remote Control’s “default” screen. Press the p or q button from the Level screen to increase or decrease stimulation strength. Stimulator Battery Status The Level screen also displays the Stimulator battery status in the top center of the screen. Three solid bars represent a fully charged Stimulator.
- Page 57 Rechargeable Stimulator System 1. Press once to access the Program selection screen, and then press as needed to highlight the desired program. Note: Typically, patients will want to highlight the currently running program. This program is underlined (__). Highlighting the underlined program will save the new settings to the currently running program. 2.
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Page 58: Device Linking
Precision™ Spinal Cord Stimulator System Clinician Manual To Access the Pulse Width and Rate Options (if enabled through Bionic Navigator): 1. Press and hold the button on the Remote Control for three seconds until the Pulse Width screen " appears. This is indicated by “Width” in the bottom left corner of the screen. -
Page 59: Searching
Rechargeable Stimulator System 4. Press to confirm and continue. Press " to cancel. When linking with a Trial Stimulator, the Remote Control will ask whether existing programs on the Trial Stimulator should be cleared. If the programs on the Trial Stimulator are cleared and if the Remote Control contains existing programs, it will then ask if these should be used. - Page 60 Precision™ Spinal Cord Stimulator System Clinician Manual Selection #1 – CP Mode 1. From the Clinician Options menu, highlight “CP Mode” and press the button to select this menu item. This will prepare the Remote Control for communication with the Clinician Programmer (CP). When in CP Mode, “CP Ready”...
- Page 61 Rechargeable Stimulator System The Clinician Programmer can communicate with either an External Trial Stimulator or an IPG. Arrange for the patient to be seated within two feet of the Remote Control to ensure an adequate communication link from the programmer to the Stimulator. For instructions on how to use the Clinician Programmer with the BionicNavigator software to program the IPG and transfer programs to the Remote Control, see the BionicNavigator Software Guide.
- Page 62 Precision™ Spinal Cord Stimulator System Clinician Manual To display the impedance values press any key (other than the Stim On/Off button ). Impedance values for contacts 1 - 8 will be shown first. Press the key again to show impedance values for contacts 9 - 16.
- Page 63 Rechargeable Stimulator System Selection #3 – To Clear Link When the “Clear Link” option is selected from the Clinician Options menu, the serial number of the Stimulator will be displayed and you will be asked to confirm clearing the link. To confirm and clear the link, press the button.
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Page 64: Remote Control Battery Life
Precision™ Spinal Cord Stimulator System Clinician Manual After you select the desired language, the Remote Control will ask you to confirm the selection; press to accept. To cancel, press the " button. The Remote Control language will now change to your selected language. -
Page 65: Specifications And Technical Data
1 – 16: OFF a. The Precision System includes programmable coverage areas with each individ ual electrode contact limited to 12.7 mA. A programming interlock is enforced to limit the coverage area output current to 20 mA or less. For example, a maximum current output of 12.7 mA on a first electrode would limit the total summed current output on remaining electrodes to 7.3 mA within one... -
Page 66: Max Current Amp. Per Electrode Vs. Impedance
Precision™ Spinal Cord Stimulator System Clinician Manual Max Current Amp. per Electrode vs. Impedance Clinician Manual 97035873-01 62 of 75... - Page 67 Specifications and Technical Data Linear Lead Part Specifications Lead Lengths 30, 50, 70 cm Lead Shape In-line Lead Diameter 1.3 mm Number of Electrode Contacts Electrode Length 3 mm Electrode Spacing 1, 4 or 6 mm Contact Material Platinum/Iridium Insulation Material Polyurethane Conductor Material MP35N-DFT-28% Ag...
- Page 68 Precision™ Spinal Cord Stimulator System Clinician Manual Lead Extension Part Specifications Extension Lengths 25, 35, 55 cm Extension Diameter 1.3 mm Number of Electrode Contacts Contact Material Platinum/Iridium, Stainless Steel Insulation Material Polyurethane, Silicone Conductor Material MP35N-DFT-28% Ag Surgical Lead...
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Page 69: Registration Information
Fill out the registration form included in the package contents. Return one copy to Boston Scientific, keep one copy for patient records, provide one copy to the patient, and one copy to the physician. -
Page 70: Technical Service
Precision™ Spinal Cord Stimulator System Clinician Manual Technical Service Boston Scientific has highly trained service professionals located worldwide to assist you. The Technical Service Department is available to provide technical consultation 24 hours a day. In North America, please call (866) 566-8913 to speak to a representative. -
Page 71: Electromagnetic Compatibility
Ordinary Equipment • Class II The Precision System is intended for use in electromagnetic environment specified below. The customer or the user of the Precision System should assure that it is used in such an environment. Emissions Test Compliance Electromagnetic Environment-guidance... - Page 72 Precision™ Spinal Cord Stimulator System Clinician Manual Guidance and manufacturer’s declaration – electromagnetic immunity The Spectra WaveWriter Spinal Cord Stimulator System is intended for use in the electromagnetic environment specified below. The customer or the user of the Spectra WaveWriter Spinal Cord Stimulator System should assure that it is used in such an environment.
- Page 73 Electromagnetic Compatibility Guidance and manufacturer’s declaration – electromagnetic immunity The Spectra WaveWriter Spinal Cord Stimulator System is intended for use in the electromagnetic environment specified below. The customer or the user of the Spectra WaveWriter Spinal Cord Stimulator System should assure that it is used in such an environment.
- Page 74 Precision™ Spinal Cord Stimulator System Clinician Manual NOTE These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy.
- Page 75 Recommended separation distances between portable and mobile RF communications equipment and the Precision System The Precision System is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Precision System can help prevent electromagnetic interference by maintaining a minimum distance of 30 cm between portable and mobile RF communications equipment (transmitters) and the Precision System.
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Page 76: Limited Warranty - Ipg
Boston Scientific Corporation (referred to as Boston Scientific) warrants to the patient who receives a Precision Implantable Pulse Generator (referred to as the IPG) that the IPG will be free from defects in workmanship and materials for a period of (5) five years from the date of surgical implant of the IPG. This warranty applies only to the patient who has the IPG implanted and no other person or entity. -
Page 77: Limited Warranty - Leads
1. The product registration card must be completed and returned to Boston Scientific within 30 days of surgery in order to obtain warranty rights. 2. The Lead, Extension, or Splitter must be returned to Boston Scientific (or authorized agent) within 30 days of malfunction or discovery of defect, and shall be the property of Boston Scientific. -
Page 78: Limited Warranty - Externals
If a Remote Control Device or Charging System component fails to function within normal ranges within one year after the date of purchase, Boston Scientific will replace the device or component with a functionally equivalent device or component made by Boston Scientific. No other relief whatsoever is available under this limited warranty. -
Page 79: Patient Identification
The Precision System components should only be serviced by Boston Scien tific. Do not attempt to open or repair any of the components. Unauthorized opening of or attempts to repair the components will void the warranty. - Page 80 Legal Manufacturer Australian Sponsor EU Authorized Representative Address Boston Scientific Neuromodulation Boston Scientific (Australia) Pty Ltd Boston Scientific Limited Corporation Ballybrit Business Park PO Box 332 25155 Rye Canyon Loop BOTANY Galway, Ireland Valencia, CA 91355 USA NSW 1455 T: +33 (0) 1 39 30 97 00...
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the best way to use the Boston Scientific patch on the charger
Use the Boston Scientific Precision Charger with the adhesive patch or Charging Belt as shown in the instructions. Failure to do so may result in a burn. If pain or discomfort occurs, stop charging and contact Boston Scientific.
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@Mr. Anderson this is good to know, as I was not told about the possibility of being burned... I can see how that could happen, but admittedly, my "charger" usually turns off way before a temperature that could burn, and even with the sticker thing, it could burn if you're sitting/laying down, I'm sure. Mine gets very hot using it with the sticker if it is covered. Well, by very hot I mean, very warm to the touch - hot enough to power off the charger and leave me wondering whether it has been off for a long time or not. Anyway, thanks for the warning. Just thought I would add on some, since I have apparently been doing everything wrong until now. Maybe it'll help someone else.