Summary of Contents for SPR Therapeutics SPRINT
- Page 1 SUPPLEMENTAL PATIENT INSTRUCTIONS FOR USE Instructions for SPRINT® PNS Systems © 2023 SPR Therapeutics, Inc. All rights reserved.
- Page 2 Information on patents can be found at: sprtherapeutics.com/patents SPR Therapeutics, SPRINT®, MicroLead™ and OnePass Introducer™, endura®, extensa®, extensa XT™ and Bimodal™ are trademarks of SPR Therapeutics, Inc., registered in the U.S. and other countries. The BLUETOOTH® word mark and logos are registered trademarks owned by Bluetooth SIG, Inc.
- Page 3 The SPRINT® Lead Securement Component Kit is a set of product components that allow you to use the new MicroLead Connector(s), Breakaway Connector Cable(s), and Mounting Cradles with your SPRINT® PNS System. Use the instructions below in place of the following chapters in the Patient Instructions For Use (IFU) when using these components:...
- Page 4 • Mounting Cradles (REF 9663): Adhesive pad that holds the MicroLead Connector in place near the MicroLead exit site to minimize the potential for Lead dislodgement. • Supplemental Patient Instructions For Use for the Lead Securement Component Kit. SPRINT PNS System | Supplemental Patient Instructions For Use – L0267[C] ®...
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Page 5: Connecting And Disconnecting The System
WARNING Do not place the SPRINT Mounting Pad on the head or on the front of the throat. Placement of the Mounting Pad on head or front of the throat may cause severe muscle spasms resulting in closure of the airway, difficulty breathing, or adverse effects on heart rhythm or blood pressure. - Page 6 5. For a Single Lead System: Connect the Pulse Generator to the Magnetic Coupler. DUAL-LEAD: Connect the Dual Lead Adapter to the Pulse Generator and connect both Magnetic Couplers to the Dual Lead Adapter. SPRINT PNS System | Supplemental Patient Instructions For Use – L0267[C] ®...
- Page 7 NOTE: Actual Bandage shape and location may vary Single-Lead System – Connected Dual-Lead System – Connected Magnetic Coupler Dual-Lead Adapter Breakaway Connector Cable MicroLead Connector Pulse Generator SPRINT PNS System | Supplemental Patient Instructions For Use – L0267[C] ®...
- Page 8 3. Unsnap the Pulse Generator from the Mounting Pad. 4. Remove the Mounting Pad by slowly peeling it off your skin. Return the Pad to its liner if it will be reused. SPRINT PNS System | Supplemental Patient Instructions For Use – L0267[C] ®...
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Page 9: Cleaning And Care
Watch the exit sites for signs of infection. These include redness, swelling, drainage, bleeding or a bad smell. Immediately tell your provider if any of these are present. SPRINT PNS System | Supplemental Patient Instructions For Use – L0267[C] ®... - Page 10 Follow these instructions to replace: 1. Wash your hands 2. Hold the MicroLead Connector stable while peeling off the old Bandage. Bandage shape may vary MicroLead Connector and Cradle SPRINT PNS System | Supplemental Patient Instructions For Use – L0267[C] ®...
- Page 11 To reduce the risk of infection, do not place the MicroLead Connector or the Mounting Cradle directly on top of the MicroLead exit site. – Connect the small magnetic plug to the Breakaway Connector Cable. SPRINT PNS System | Supplemental Patient Instructions For Use – L0267[C] ®...
- Page 12 (See “Connecting the System” in the Patient IFU.) Do not let the adhesive portion of the bandage touch the MicroLead exit site or the MicroLead Connector. This could result in the MicroLead being pulled out. SPRINT PNS System | Supplemental Patient Instructions For Use – L0267[C] ®...
- Page 13 Rechargeable Batteries and the Remote must never be disposed of in a fire because they contain batteries. For full instructions, including indications, contraindications, warnings, and precautions, see Patient Instructions for Use. SPRINT PNS System | Supplemental Patient Instructions For Use – L0267[C] ®...
- Page 14 NOTES __________________________________________________________________________________________ __________________________________________________________________________________________ __________________________________________________________________________________________ __________________________________________________________________________________________ __________________________________________________________________________________________ __________________________________________________________________________________________ __________________________________________________________________________________________ __________________________________________________________________________________________ __________________________________________________________________________________________ __________________________________________________________________________________________ __________________________________________________________________________________________ __________________________________________________________________________________________ __________________________________________________________________________________________ __________________________________________________________________________________________ __________________________________________________________________________________________ __________________________________________________________________________________________ __________________________________________________________________________________________ __________________________________________________________________________________________ __________________________________________________________________________________________ __________________________________________________________________________________________ __________________________________________________________________________________________ __________________________________________________________________________________________ SPRINT PNS System | Supplemental Patient Instructions For Use – L0267[C] ®...
- Page 15 NOTES __________________________________________________________________________________________ __________________________________________________________________________________________ __________________________________________________________________________________________ __________________________________________________________________________________________ __________________________________________________________________________________________ __________________________________________________________________________________________ __________________________________________________________________________________________ __________________________________________________________________________________________ __________________________________________________________________________________________ __________________________________________________________________________________________ __________________________________________________________________________________________ __________________________________________________________________________________________ __________________________________________________________________________________________ __________________________________________________________________________________________ __________________________________________________________________________________________ __________________________________________________________________________________________ __________________________________________________________________________________________ __________________________________________________________________________________________ __________________________________________________________________________________________ __________________________________________________________________________________________ __________________________________________________________________________________________ __________________________________________________________________________________________ SPRINT PNS System | Supplemental Patient Instructions For Use – L0267[C] ®...
- Page 16 SUPPLEMENTAL PATIENT INSTRUCTIONS FOR USE Lead Securement Landing Page QR Code https://www.sprtherapeutics.com/video/lead-secu... Patient Instructional Videos https://kaywa.me/pIjw2 Scan this QR code with a smart phone camera or visit: sprtherapeutics.com/instructional/ifu-patient-videos-english/ Download the Kaywa QR Code Reader (App Store &Android Market) and scan your code! 22901 Millcreek Blvd Cleveland, OH, 44122 USA support@sprtherapeutics.com...
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