Lead and Extension Insertion Tool. Model Clinician's Manual

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1 Lead and Extension Insertion Tool Model 1803 Clinician's Manual

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, LLC and its related companies. Pat St. Jude Medical, LLC. All Rights Reserved.

3 Prescription and Safety Information Read this section to gather important prescription and safety information. Intended Use The St. Jude Medical lead and extension insertion tool is a hand-manipulated device that is intended for a single use to help insert the terminal end of a neurostimulation lead, extension, or adapter into the header of an implantable pulse generator (IPG) during implantation of a neurostimulation system. Additional Prescription Information Refer to the clinician's manual for the appropriate neurostimulation system to get additional prescription information, including indications for use and contraindications. For specific instructions, warnings, precautions, and adverse effects about other system components, see the clinician's manual for those components. Precautions The following precautions apply to these components. Single use only. Sterilized devices are intended for single use only. Sterile components in this kit have been sterilized using ethylene oxide (EtO) gas before shipment and are supplied in the sterile packaging 1

4 to permit direct introduction into the operative field. Do not resterilize or reuse them because of the risk of infection. Expiration date. An expiration date (or use-before date) is printed on the packaging. Do not use the system if the use-before date has expired. Package or component damage. Do not use a device if the sterile package or components show signs of damage, if the sterile seal is ruptured, or if contamination is suspected for any reason. Return any suspect components to St. Jude Medical for evaluation. Compatibility Guidelines The St. Jude Medical lead and extension insertion tool is compatible with the following devices for spinal cord stimulation (SCS) and deep brain stimulation (DBS). NOTE: Not all models are available in all countries. Contact your local representative for more information. Table 1. Device compatibility Component Device Model Number SCS DBS IPGs Proclaim 5 IPG 3661, 3665 X Proclaim 5 Elite IPG 3660 X 2

5 Table 1. Device compatibility Component Device Model Number SCS DBS Proclaim 7 IPG 3663, 3667 X Proclaim 7 Elite IPG 3662 X Prodigy IPG 3799 X Prodigy MRI IPG 3772 X Eon IPG 3716 X Eon Mini IPG 3788 X EonC IPG 3688 X Genesis IPG 3608 X St. Jude Medical Infinity 5 IPG 6660, 6661 X St. Jude Medical Infinity 7 IPG 6662, 6663 X Brio IPG 6788 X Leads 3100-series percutaneous leads 31XX X 3200-series paddle leads 32XX X 3

6 Table 1. Device compatibility Component Device Model Number SCS DBS Extensions 3300-series extensions 3341, 3343, 3346, 3383, series extensions 6315, 6316, 6319, 6345, 6346 Extensions for the St. Jude Medical Infinity DBS System 6339, 6340, 6343, 6344, 6355, 6356, 6359, 6361, 6362, 6363, 6371, 6372, 6373, 6377, 6378, 6379 Adapters 8-channel adapter, M 2311, 2316 X X 8-channel adapter, B 2321, 2326 X X X X X 4

7 The lead and extension insertion tool is compatible with Medtronic lead and extension models available before May 5, (Medtronic is a trademark of Medtronic, Inc.) Table 2. Device compatibility (Medtronic) Device Model Number SCS permanent lead , , , , , , , , , , , , , , , , , , , , , SCS extension , , , , , , , , DBS extension* , , * The specified DBS extensions are connected to Medtronic DBS leads (Model 3387 or 3389). 5

8 Product Description The St. Jude Medical lead and extension insertion tool is a nonpowered, hand-held, surgical accessory that is intended to help insert a neurostimulation lead, extension, or adapter into an IPG header. The insertion tool has five main areas: gripping surface, tip, tab, wing, and lead or extension channel. The following figure shows the features of the lead and extension insertion tool. Figure 1. Lead and extension insertion tool features 1. Gripping surface 2. Tip 3. Tab 4. Wing 5. Lead or extension channel 6

9 Package Contents The lead and extension insertion tool kit (Model 1803) contains five individually packaged, sterile lead and extension insertion tools. Directions for Use After the lead or extension is implanted at the desired location and has been tunneled to the IPG pocket, use the lead and extension insertion tool to insert the terminal end of the lead or extension into the IPG header. To use the lead and extension insertion tool, follow these steps: NOTE: For information on lead and extension placement, see the directions for use in the clinician's manual for the appropriate lead or extension kit. 1. Before using the insertion tool, manually insert the lead or extension into the IPG header and slide the lead or extension until it becomes difficult to advance further into the header. 2. Holding the insertion tool between your forefinger and thumb, place the tool around the terminal end of the lead or extension such that the tip is 2 to 3 mm from the last visible contact band. 7

10 Figure 2. Insertion tool placed around the terminal end of the lead or extension 1. Insertion tool 2. Last visible contact band on the terminal end of the lead or extension NOTE: To prevent damage to the lead or extension, ensure the gripping surface of the tool does not cover the electrode or the contact band. 3. Using your forefinger and thumb, pinch the gripping surface of the insertion tool until the tool closes around the lead or extension body. When the lead or extension is properly seated within the channel of the tool, both wings of the tool are flush together. 8

11 Figure 3. Correct versus incorrect insertion of tool into the header port 1. (Correct) Tip of tool is closed and perpendicular to the header 2. (Incorrect) Tip of tool is open and bent NOTE: To prevent damage to the insertion tool when inserting it into the header of the IPG, ensure the tip of the tool remains closed and in full contact with the lead or extension body. NOTE: The insertion tool is designed for a portion of the tip of the tool to enter the header port of the IPG during insertion of the lead or extension. 4. While applying pressure to the gripping surface of the insertion tool, advance the terminal end of the lead or extension and push the tip of the tool into the appropriate header port until the terminal end is fully inserted into the header, as described in the clinician's manual for the appropriate IPG. 9

12 Figure 4. Tip of tool inserted into the header port 5. While the tool and the lead or extension are fully inserted into the IPG header, use the torque wrench provided in the IPG kit to tighten the setcrew. 6. Release the gripping surface by regrasping the tool with your forefinger at the edge of the wings and your thumb at the tab. 10

13 Figure 5. Regrasping the tool to release the gripping surface 7. Pull back on the tool to remove it from the IPG header port. The terminal end of the lead or extension remains fully inserted in the header port. 8. Repeat the steps in this section for additional leads or extensions. 9. Follow the instructions for inserting port plugs into any unused ports (if needed) and placing the IPG as described in the clinician's manual for the appropriate IPG. 11

14 Technical Support For technical questions and support for your St. Jude Medical neuromodulation product, use the following information: (toll-free within North America) For additional assistance, call your local St. Jude Medical representative. Appendix A: Product Specifications The lead and extension insertion tool (Model 1803) has the following physical specifications. Table 3. Lead and extension insertion tool specifications Length Width Weight Storage temperature 3.18 cm (1.25 in) 2.29 cm (0.90 in) 0.62 g (0.02 oz) -10 C 55 C (14 F 131 F) 12

15 Appendix B: Symbols and Definitions The following symbols may be used in this document and on some of the products and packaging: Table 4. Symbols and definitions Symbol Definition Caution, consult accompanying documents Consult instructions for use Follow instructions for use on this website Single use only Do not resterilize Expiration date 13

16 Table 4. Symbols and definitions Symbol Definition Date of manufacture Manufacturing facility Temperature limits for storage conditions Humidity limits Pressure limits Do not use if the product sterilization barrier or its packaging is compromised 14

17 Table 4. Symbols and definitions Symbol Definition Catalog number Manufacturer Contents quantity Accessories Lot number Prescription use only Ethylene oxide gas sterilization Authorized European representative Australian Sponsor 15

18 Table 4. Symbols and definitions Symbol Definition 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. Additional Symbols for Product Labels The following table shows additional symbols that may appear on the product labels for parts related to this kit. Table 5. Additional symbols for product labels Symbol Definition Lead and extension insertion tool 16

19 Appendix C: CE Mark Date The following table lists the year in which the CE mark was awarded by model number. Table 6. Year in which CE mark was awarded Model Year

20 St. Jude Medical 6901 Preston Road Plano, Texas USA St. Jude Medical Coordination Center BVBA The Corporate Village Da Vincilaan 11 Box F Zaventem Belgium St. Jude Medical Australia Pty. Limited 17 Orion Road Lane Cove NSW 2066 Australia St. Jude Medical Puerto Rico LLC Lot A Interior - #2 Rd Km Santana Industrial Park Arecibo, PR USA sjm.com St. Jude Medical Operations (M) Sdn. Bhd. Plot 102, Lebuhraya Kampung Jawa, Bayan Lepas Industrial Zone Penang Malaysia ARTEN A * *

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