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.
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 Length Max Implant Depth Sterilized using Ethylene Oxide Content of unopened, undamaged package is sterile Single Use The Pulsante® Microstimulator is MR Unsafe.
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® Programmer Software on Clinician Programmer: Tilt Symbol indicates that the selected stimulation amplitude is not being delivere
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. Pulsante® Remote Controller A rechargeable handheld device used by the patient to activate and control the Microstimulator.
Figure 2: Pulsante® Remote Controller COMMUNICATION DISK (ROUNDED END OF REMOTE) UP BUTTON DOWN BUTTON USB PORT DISPLAY SCREEN POWER BUTTON Front View Figure 3: Pulsante® Microstimulator Side View Bottom View Figure 4: Remote Controller Charger (Coin shown for size) Figure 5: Pulsante® Programming Software on Clinician Programmer 5
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. Ensure the patient meets the indications for use. Intra-Operative Expose the superior-lateral surface of the zygomaticomaxillary buttress region.
using the Surgical Introducer (SI‑100 or SI‑110) as a guide. Remove the Surgical Introducers leaving the lead in the fossa. 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.
Procedures of the Pterygopalatine Fossa The SPG is located within a space behind your nose called the pterygopalatine fossa. This is where part of your Microstimulator is implanted. The effects of other procedures on the Microstimulator in this area are not known. Permanent damage to the Microstimulator may result from these procedures.
implant location may prevent communication between the Remote Controller and the implanted Microstimulator, and therapy may not be possible. If the distance between the devices is greater than 2.5cm, the Remote Controller may not be able to communicate with the Microstimulator. If it is difficult to establish communication with the Microstimulator, re-evaluate the implant depth specified in the Programming Software. Lead Tip Migration The Microstimulator Lead may migrate from its initial implant location.
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.
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.
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. • Do not attempt to reuse or re-sterilize the Microstimulator. The Microstimulator is intended for single use only.
• • The Clinician Programmer can be safely stored and operated between 5°C and 40°C. The Clinician Programmer can be transported between 20°C and +70°C. Temperatures outside of this range may reduce battery life. Do not connect the USB Port to any other electrical device other than the Tablet Charger or Programming USB cable provided with the Clinician Programmer. 11. OPERATOR’S INSTRUCTIONS: HOW TO IMPLANT THE MICROSTIMULATOR A.
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. Complete an interrogation of the Microstimulator and perform an electrode impedance test to ensure proper functionality as detailed in Section 11, Part H.
Figure 9: Initial Dissection Figure 10: Initial Dissection Detail Using fluoroscopy or other visualization, advance the Surgical Introducer from the posteriorlateral 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.
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 16
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).
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.
F. Adjust Placement as Needed To refine placement, small adjustments may be made to the electrode position in the fossa with respect to the vidian canal and foramen rotundum. Make any needed adjustments by grasping the Microstimulator body or bone plate to advance or retract the lead in the fossa. Intraoperative images are taken to confirm final placement of the Microstimulator in the appropriate location. G. Attach the Microstimulator Use the Bone Fixation Plate and at least two 1.
option in the Programming Software. If the Programming Software confirms that the impedance test is successful, then the procedure may proceed. If the test is not successful, then select a higher implant depth and repeat the test. If the Microstimulator does not respond to repeated testing, then a new Mircrostimulator must be used. Refer to the Pulsante® Programming Manual for information on proper use of the Programmer Software and Remote Controller.
13. TECHNICAL DESCRIPTION AND SPECIFICATIONS USA-Federal Communications Commission (FCC) The following is communication regulation information on the Pulsante SPG microstimulator system comprises of Neurostimulator NS-100 and Remote Controller RC-300. FCC ID of the system: 2APE8-RC300 Labeling Note: FCC ID information can be retrieved by pressing and holding the Remote Controller RC-300 power button for 10seconds. This device complies with Part 15 of the FCC Rules.
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.
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.
Specifications for the Pulsante® Remote Controller: PHYSICAL CHARACTERISTICS Remote Controller Size SPECIFICATION 17.7 x 7.9 x 2.4 (Height x Width x Thickness) cm ± 10% Weight 10.3 oz ± 10% Case Material Connector Storage / Transport Temperature Range / Humidity PC-ABS Micro USB Port The Remote Controller can be safely stored between 5°C and 40°C. The Remote Controller can be transported between -20°C and +70°C. Temperatures outside of this range may reduce battery life.
