Autonomic Pulsante 5492001 Manual

Spg microstimulator system

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5492001 - Pulsante® SPG Microstimulator System Implant Manual

CONTENTS

1. Welcome . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

2. Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

3. Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

4. Implant Identification Card . . . . . . . . . . . . . . . . . . 3

5. System Overview . . . . . . . . . . . . . . . . . . . . . . . . . 3

6. Implant Procedure Overview . . . . . . . . . . . . . . . . 6

7. Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . 7

8. Warnings & Precautions . . . . . . . . . . . . . . . . . . . 7

9. Risks & Side Effects . . . . . . . . . . . . . . . . . . . . . . 11

10. Storage & Handling . . . . . . . . . . . . . . . . . . . . . . .12

11. How to Implant the Microstimulator . . . . . . . . 13

12. Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

13. Technical Specifications . . . . . . . . . . . . . . . . . . . 20

14. Information and Support . . . . . . . . . . . . . . . . . . . 23

1. WELCOME

Welcome to the Pulsante® family! The instructions in this Manual are intended for physician

implanters of the Pulsante® SPG Microstimulator. Please familiarize yourself with the Implant

Manual, Programming Manual, and Patient Manual prior to using the Pulsante® SPG Microstimulator

System.

2. INTENDED USE OF THE PULSANTE® SPG MICROSTIMULATOR SYSTEM

In the United States, the Pulsante® SPG Microstimulator System is intended to relieve the acute pain

of cluster headache.

3. SYMBOLS

Symbols and definitions used for the Pulsante® SPG Microstimulator System:

For Prescription Use Only

Consult Operating Instructions

Model Number

Serial Number

Lot Number

Content

Use Only With

Peel Apart

Warning/Precaution

Storage and Transport Temperature Range

Keep Dry

Manufactured By

Table of Contents

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Summary of Contents for Autonomic Pulsante 5492001

Page 1: Table Of Contents
5492001 – Pulsante® SPG Microstimulator System Implant Manual CONTENTS 1. Welcome ....... 1 2.
Page 2 Do Not Do the following Do not dispose devices in unsorted trash. Dispose devices per local country regulations for disposing electrical equipment Do not use device if package is opened or damaged Date of Manufacture Use By Date Symbols and definitions used only for the Pulsante® Microstimulator: Electrode Channel Constant Current...
Page 3: Implant Identification Card
Press Up or Down Button symbol Searching For Microstimulator antenna symbol Recharge Remote symbol Low Battery symbol Depleted Battery symbol Battery Charging symbol Fully Charged Battery symbol Alert Indicator symbol Symbols and definitions used only for the Pulsante® Surgical Tools: Single Use Only Sterilized using Ethylene Oxide Symbols and definitions used for the Pulsante®...
Page 4 Figure 1: Location of the Implanted Pulsante® Microstimulator The Pulsante® SPG Microstimulator System consists of the following: Pulsante® SPG Microstimulator A miniaturized implant with an integral lead, which has six stimulating electrodes placed near the sphenopalatine ganglion. Pulsante® Surgical Tools Surgical Tools used during implantation of the Microstimulator.
Page 5 Figure 2: Pulsante® Remote Controller COMMUNICATION DISK (ROUNDED END OF REMOTE) UP BUTTON DOWN BUTTON USB PORT DISPLAY SCREEN POWER BUTTON Front View Side View Bottom View Figure 3: Pulsante® Microstimulator Figure 4: Remote Controller Charger (Coin shown for size) Figure 5: Pulsante®...
Page 6: Implant Procedure Overview
Figure 6: Surgical Introducers 100 & 110 Figure 7: Lead Blank 6. IMPLANT PROCEDURE OVERVIEW Pre-Operative Pre-operative facial bone/paranasal sinus Computed Tomography (CT) scan or Magnetic Resonance Imaging (MRI) may be used for surgical planning and to estimate the appropriate Microstimulator length for a specific patient.
Page 7: Contraindications
Anchor the Microstimulator Body to the anterior zygomatic process of the maxilla using the Bone Fixation Plate and at least two bone screws. NOTE: Bone screws are not supplied by Autonomic Technologies. 7. PULSANTE® SPG MICROSTIMULATOR SYSTEM CONTRAINDICATIONS The Pulsante®...
Page 8 The effects of certain electrical therapies and diagnostic imaging on the Microstimulator are not well understood. If you require such treatment, your doctor should consult Autonomic Technologies for current information on how electrical therapies and diagnostic imaging could affect your device.
Page 9 If the patient requires such devices, the physician should consult Autonomic Technologies for current information concerning the compatibility of such devices. Cardiac Defibrillation/Cardioversion The effect of internal or external defibrillation or cardioversion on the implanted Microstimulator is not known.
Page 10 power lines may generate sufficient EMI to cause paresthesia (a sensation of tingling, pricking or numbness in the face) or interfere with the System. If a patient is uncomfortable or unable to apply therapy when near such equipment, the patient should move away from the area of EMI. The system has been designed to fail safely so strong EMI could prompt the Remote Controller to turn off.
Page 11: Risks & Side Effects
9. RISKS AND SIDE EFFECTS Please discuss the risks and benefits with your doctor to determine if the device is right for you. Risks of neurostimulation therapy can include surgical risks, possible side effects, or device complications. Your doctor can provide more information about these and other potential risks. Please follow your doctor’s instructions after surgery to minimize surgical risk.
Page 12: Storage & Handling
10. PACKAGING, STORAGE AND HANDLING Pulsante® SPG Microstimulator • The Microstimulator is provided sterile. The Microstimulator is sterilized using ethylene oxide. • Do not excessively bend the Microstimulator Lead or Bone Fixation Plate. Excessive bending may damage the integrity of the Microstimulator and may affect device performance. •...
Page 13: How To Implant The Microstimulator
• Remote Controller with Remote Controller Charger • Programmer Software on a Clinician Programmer with Tablet Charger and Programming USB cable The following accessories are not supplied by Autonomic Technologies and will need to be available at the implanting facility: • Craniomaxillofacial surgical equipment, specifically including: ▪...
Page 14 C. Preparing Devices Assess the tips of the Surgical Introducers to determine which one(s) will be used for the procedure. Prior to placing the Microstimulator, place the Microstimulator in physiologic saline inside a sterile plastic basin away from a metal surface with the Microstimulator Lead completely submerged.
Page 15 Figure 9: Initial Dissection Figure 10: Initial Dissection Detail Using fluoroscopy or other visualization, advance the Surgical Introducer from the posterior- lateral edge of the zygomaticomaxillary buttress towards the pterygopalatine fossa (PPF) using gentle pressure (Figure 9). The Surgical Introducer is advanced along the posterior maxilla until the distal tip of the Surgical Introducer is within the pterygomaxillary fissure, or just within the PPF.
Page 16 Figure 11: Inserting the Surgical Introducer Figure 12: Close-Up View of the Surgical Introducer Inserted Figure 13: Example Anterior-Posterior Fluoroscopy Image of Surgical Introducer Placement...
Page 17 If the Microstimulator size was not chosen beforehand, then it can be chosen during the procedure. To do so, estimate the appropriate Microstimulator length by using the centimeter scale on the medial surface of the Surgical Introducers (Figure 6 and Figure 12) once it is positioned correctly at the pterygomaxillary fissure or within the PPF (Figure 13).
Page 18 Figure 15: Example Fluoroscopy View of the Lead Blank Extended Beyond the Surgical Introducer Within the Pterygopalatine Fossa • Do not apply excessive force to the Lead Blank when advancing into the pterygopalatine fossa. • Do not advance the Lead Blank beyond the pterygopalatine fossa. Patient injury or poor outcomes may result from further advancement of the Lead Blank.
Page 19 Use the Bone Fixation Plate and at least two 1.8 mm craniomaxillofacial bone screws (not provided by Autonomic Technologies) to anchor the Microstimulator to the anterior zygomatic process of the maxilla, which contains thick, dense bone (Figure 16). Care should be taken to confirm that the distal lead has not entered the inferior orbital fissure or nasal cavity.
Page 20: Disposal
Do not throw away the Remote Controller in the trash. Microstimulator In the event that an Microstimulator is explanted, please return the device to Autonomic Technologies for analysis. Do not throw away the Microstimulator in the trash. Surgical Tools The Surgical Tools are intended for single use only.
Page 21 No.004-000-00345-4. Electromagnetic Compatibility The use of cables other than those specified or sold by Autonomic Technologies may result in increased emissions or decreased electrical immunity of the system. The RF transmitter within the remote controller operates at 126 kHz +/- 3kHz, with Frequency Shift Keying (FSK), and the effective radiated power of less than 5mW.
Page 22 GUIDANCE AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC EMISSIONS The Pulsante® SPG Microstimulator System is intended for use in the electromagnetic environment specified below. The customer or user of the Pulsante® SPG Microstimulator System should assure that it is used in such an environment. EMMISSIONS/IMMUNITY TEST LEVEL COMPLIANCE LEVEL...
Page 23 should be less than the compliance level in each frequency range (Note B). Interference may occur in the vicinity of equipment marked with the following symbol. Note 1: At 80 MHz and 800 MHz. The higher frequency range applies. Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people.
Page 24: Information And Support
1.2A Output Power 6 Watts Max Switching Frequency 66.5 kHz Typical 14. INFORMATION AND SUPPORT Autonomic Technologies 355 Ravendale Drive, Mountain View, CA 94043 USA www.pulsante.com Pulsante® is a trademark of Autonomic Technologies © 2017 Autonomic Technologies All rights reserved.