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Summary of Contents for St. Jude Medical 3046
- Page 1 Percutaneous Trial Lead Kit Models 3046, 3086 Clinician's Manual...
- Page 2 Unless otherwise noted, ™ indicates that the name is a trademark of, or licensed to, St. Jude Medical or one of its subsidiaries. ST. JUDE MEDICAL and the nine-squares symbol are trademarks and service marks of St. Jude Medical, Inc. and its related companies.
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Page 3: Table Of Contents
Contents Prescription and Safety Information ................1 Intended Use ........................1 Indications for Use ......................1 Contraindications ....................... 1 Warnings .......................... 1 Precautions ........................2 Adverse Effects........................3 Product Description ....................3 Package Contents ......................3 Directions for Use...................... 4 Placing Percutaneous Leads .................... -
Page 5: Prescription And Safety Information
Read this section to gather important prescription and safety information. Intended Use The percutaneous leads covered in this manual are intended to be used with St. Jude Medical™ trial systems for SCS during a trial period that shall not exceed 30 days. -
Page 6: Precautions
IPG and proceed with caution, being sure to move through the detector quickly. Device components. The use of components that are not approved by St. Jude Medical with this system may result in damage to the system and increased risk to the patient. -
Page 7: Adverse Effects
Product Description St. Jude Medical™ leads are designed for spinal cord stimulation (SCS) to aid in the treatment of chronic, intractable pain. SCS is a method of pain control that uses low-intensity electrical impulses to stimulate nerve fibers within the spinal cord, often inhibiting chronic pain messages from reaching the brain. -
Page 8: Directions For Use
Directions for Use Carefully review the following suggested guidelines for implantation of percutaneous trial leads. If implanting multiple leads, repeat the appropriate steps for each lead. For directions for use for other system components not covered in this document, see the clinician’s manual for the appropriate device. - Page 9 Figure 2. Insert epidural needle using paramedian approach Figure 3. Insert needle at an angle of 30° or less 1. Spinal cord 2. Ligamentum flavum 3. Epidural space 4. Dural sac Confirm entry into the epidural space using standard methods such as the loss-of-resistance technique (see the following figure).
- Page 10 Figure 4. Use loss-of-resistance technique to confirm entry Under fluoroscopic guidance, insert the guide wire, with the stylet slightly withdrawn, through the needle into the epidural space (see the following figure). Withdrawing the stylet slightly increases the flexibility of the guide wire tip and minimizes the risk of a dural tear. Figure 5.
- Page 11 Figure 6. Advance the guide wire to the target 1. Fully insert the stylet 2. Advance the guide wire If using the lead introducer to place the lead (optional), remove the needle using the hold- and-push technique, leaving the guide wire in the epidural space (see the following figure). Figure 7.
- Page 12 Figure 8. If using the lead introducer (optional), insert the lead introducer 1. Hold the guide wire 2. Insert the lead introducer If using the lead introducer (optional), after the lead introducer reaches the desired spinal level for electrode placement, remove the guide wire (see the following figure). Figure 9.
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Page 13: Securing The Trial Lead
Disposing of Explanted Components Explanted St. Jude Medical™ components should be returned to St. Jude Medical for proper disposal. To return an explanted component, place it in a container or bag marked with a biohazard label and coordinate the return with your St. -
Page 14: Technical Support
Technical Support For technical questions and support for your St. Jude Medical™ neuromodulation product, use the following information: +1 972 309 8000 +1 800 727 7846 (toll-free within North America) For additional assistance, call your local St. Jude Medical representative. -
Page 15: Lead Specifications
Lead Specifications Table 4. Percutaneous lead specifications Description Octrode™ Quattrode™ 3/4 Lead length and model 60 cm 3086 3046 Lead diameter 1.4 mm 1.4 mm Electrodes Number Length 3 mm 3 mm Longitudinal spacing 4 mm 4 mm Center-to-center spacing... -
Page 16: Appendix B: Regulatory Statements
This section contains regulatory statements about your product. Declaration of Conformity Hereby, St. Jude Medical declares that this medical device is in compliance with the essential requirements and other relevant provisions of AIMD directive 90/385/EEC. For a copy of the declaration of conformity, please contact Technical Support. -
Page 17: Additional Symbols For Product Labels
Ethylene oxide gas sterilization Authorized European representative European conformity, affixed in accordance with the relevant provisions of AIMD directive 90/385/EEC. Hereby, St. Jude Medical declares that this device is in compliance with the essential requirements and other relevant provisions of this directive. -
Page 18: Appendix D: Ce Mark Date
Appendix D: CE Mark Date The following table lists the year in which the CE mark was awarded by model number. Table 7. Year in which CE mark was awarded Model Year 1102, 1105, 1106, 1114, 1116, 3046, 3086 1999 1123, 1124 2001... - Page 20 +32 2 774 68 11 Manufacturing Site: Manufacturing Site: St. Jude Medical Puerto Rico LLC St. Jude Medical Operations (M) Sdn. Bhd. Lot A Interior - #2 Rd Km. 67.5 Plot 102, Lebuhraya Kampung Jawa, Santana Industrial Park Bayan Lepas Industrial Zone...
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