Neurostimulator Implant Manual Rechargeable | Model 5101 Axonics® and Axonics Sacral Neuromodulation System® are trademarks of Axonics, Inc., ® Axonics® and Neuromodulation System trademarks of Axonics, Inc., registered or Axonics pendingSacral registration in the U.S. and otherare countries. registered or pending registration in the U.S. and other countries. Axonics, Inc. 26 Technology Drive Irvine, CA 92618 (USA) www.axonics.com Tel.
LABEL SYMBOLS This section explains the symbols found on the product and packaging.
Description Symbol Use by Do not use if package is damaged Do not re-sterilize Open here For USA audiences only Caution: U.S.
Table of Contents LABEL SYMBOLS .................................................................................................................................................. 2 TABLE OF CONTENTS ......................................................................................................................................... 4 INTRODUCTION ...................................................................................................................................................
INTRODUCTION This manual provides information about the Axonics Sacral Neuromodulation (SNM) System Neurostimulator (Model 5101), which is a part of the Axonics SNM System. The Neurostimulator is connected to the Axonics Tined Lead (Model 1201 or 2201). INDICATIONS, WARNINGS, AND PRECAUTIONS • Refer to Indications for Use insert for indications and contraindications.
STORAGE AND USAGE ENVIRONMENT Component Packaging Any component that has been compromised in any way should not be implanted; this includes the re-use of non-reusable product. Do not implant the component if any of the following have occurred: • The storage package or sterile pack has been damaged, pierced, or altered, as sterility cannot be guaranteed, which may lead to infection. • The component itself shows any signs of damage. The component may not function properly. • The use-by date has expired.
SPECIFICATIONS Table 1 shows the Neurostimulator physical specifications. For detailed descriptions and specifications for other components and accessories, refer to the product literature for those devices.
X-RAY IDENTIFICATION The radiopaque marker allows physicians to identify the manufacturer and model number under standard x-ray procedures. For the Axonics Neurostimulator, the designated code is GRJ, which appears as light characters on a black background (Figure 2). Figure 2: The Axonics Neurostimulator radiopaque marker, “GRJ”.
NEUROSTIMULATOR IMPLANT PROCEDURE The following section describes the procedure for implanting the Axonics Neurostimulator. This procedure should be performed when an Axonics tined lead has already been implanted.
• The Neurostimulator implant site should be irrigated with antibiotic solution, and it is recommended that IV antibiotics be administered perioperatively. Do not soak the Neurostimulator in antibiotic solution as this may affect lead connections. Cautions • The Neurostimulator has been sterilized. The Neurostimulator should not be placed on any non-sterile surface. The Neurostimulator should not be placed on skin. An infection may require surgical removal of the implanted system. 2.
• Avoid pulling the lead body taut when implanted. Cautions • Do not attempt to insert the lead into the Neurostimulator if the setscrew is not sufficiently retracted as doing so may cause damage to the lead and/or cause the lead to not seat fully into the connector block. • Ensure that the setscrew tightens on the retention sleeve, not an electrode. Tightening the setscrew onto the contact could damage the contact, leading to lack of therapy. 5.
2. Use the Clinician Programmer to check the impedances and ensure good function and connectivity of the system. Notes: • The Neurostimulator should be in the subcutaneous pocket during system interrogation to ensure proper readings. • Refer to the Clinician Programming Manual for detailed instruction on checking the system integrity and impedances. 3. Use the suture hole in the header to secure the Neurostimulator to the muscle fascia with non-absorbable silk. Completing the Implant Procedure 1.
WIRELESS COMMUNICATION Model: 5101 FCC ID: 2AEEGS IC: 20225-S FCC Compliance This device complies with part 15 of the FCC Rules.
