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Autonomic Pulsante 5492001, Manual

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Autonomic Pulsante 5492001 Manual Download Page 4

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. 

Pulsante® Remote Controller 

A rechargeable handheld device used by the patient to activate 
and control the Microstimulator. The Remote Controller is also 
used by the physician to facilitate adjusting parameter settings 
in the Microstimulator. 

Remote Controller Charger  

The Charger is provided in the Remote Controller packaging 
and is used by the patient to charge the Remote Controller. 

Pulsante® Programming Software   Software that allows the physician to test and program 

stimulation parameters into the Microstimulator and set the 
power in the Remote Controller.  The Programming Software is 
provided on a Clinical Programmer. 

Clinician Programmer 

Medical-grade tablet that runs the Programming Software. It 
includes a Tablet Charger and Programming USB cable. 

 
NOTE: The Microstimulator and Surgical Tools are provided sterile and are sterilized using Ethylene 
Oxide. 
 
 
 
 
 
 
 
 
 
 
 

Summary of Contents for Pulsante 5492001

Page 1: ...ntended 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...

Page 2: ...mulator 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 Symbols and definitions used only for the Pulsante Remote Controller Non Ionizing Radiation Power ON OFF button symbol Up Button symbol Down Button symbol Applied Type B Equipment USB connector symb...

Page 3: ...l times The identification card must be filled out with pertinent patient information prior to the patient being discharged from the implanting center 5 PULSANTE SPG MICROSTIMULATOR SYSTEM OVERVIEW The rechargeable Pulsante SPG Microstimulator System the System electrically stimulates the sphenopalatine ganglion SPG peripheral nerve structure Figure 1 The rechargeable System includes a miniaturize...

Page 4: ...s also used by the physician to facilitate adjusting parameter settings in the Microstimulator Remote Controller Charger The Charger is provided in the Remote Controller packaging and is used by the patient to charge the Remote Controller Pulsante Programming Software Software that allows the physician to test and program stimulation parameters into the Microstimulator and set the power in the Rem...

Page 5: ...ottom View Figure 3 Pulsante Microstimulator Figure 4 Remote Controller Charger Figure 5 Pulsante Programming Software on Clinician Programmer COMMUNICATION DISK ROUNDED END OF REMOTE UP BUTTON DOWN BUTTON USB PORT DISPLAY SCREEN POWER BUTTON Coin shown for size ...

Page 6: ...the Surgical Introducer from the superior lateral buttress to the pterygopalatine fossa along the posterior maxilla The Surgical Introducer may be used to estimate the appropriate Microstimulator length by using the centimeter scale on the medial surfaces of the Surgical Introducer The Microstimulator is available in four lengths Short Approximately 3 6cm in length Medium Approximately 4 4cm in le...

Page 7: ...and accessories specifically the Microstimulator Remote Controller Charger Surgical Tools and Programmer Software Electrostatic Discharge The integral Microstimulator lead electrodes provide a low impedance pathway to the Microstimulator electronics It is recommended that all healthcare personnel handling the Microstimulator avoid directly touching the electrodes Placing the Microstimulator within...

Page 8: ...e growth stimulators and electrolysis Do Not use your Remote Controller to apply therapy while undergoing any electrical therapy or diagnostic imaging procedure Explosive or Flammable Gases Do Not use your Remote Controller in an environment where explosive or flammable gases are present Other Patient Controlled Medical Devices Do Not place the Remote Controller over other implantable devices for ...

Page 9: ... facial nerve blocks e g infra orbital or maxillary orthodontic or dental procedures e g tooth extractions or bridge implants cosmetic procedures e g lipectomy face lift radiothermoplasty laser skin removal resurfacing or dermal fillers and electrohydraulic lithotripters The following procedures or tests should only be performed and the following devices should only be used after talking to a doct...

Page 10: ...e care when handling your Remote Controller The Remote Controller is a sensitive electronic device that may be damaged by rough handling including dropping on the ground or being crushed Store the Remote Controller in a cool dry place Excess heat can reduce the battery life of the Remote Controller considerably for example patients should not leave the Remote Controller in a car or under direct su...

Page 11: ...roma Hematoma a collection of serum blood in the body Abcess Bruising Permanent numbness and other sensations Dry eye and tearing Trismus lockjaw Itching Pain in the area of the implant Infection Bleeding Facial asymmetry Allergic response to implanted materials Headache Penetration of the sinus wall Increased severity frequency of cluster headaches Post operative nausea or emesis vomiting Nose bl...

Page 12: ...it may be exposed to water or moisture Pulsante Remote Controller Do not sterilize the Remote Controller Do not store the Remote Controller where it may be exposed to water or other liquids as moisture may damage the integrity of the package materials or damage the Remote Controller Do not use the Remote Controller if the packaging or the Remote Controller look damaged The Remote Controller is a s...

Page 13: ...ent can provide an estimate of the appropriate Microstimulator length Alternatively you can estimate the appropriate Microstimulator length during the implant procedure by using the scale on the Surgical Introducers as detailed in Section F below The Microstimulator is provided in four lengths excluding the integral Bone Fixation Plate Short Approximately 3 6 cm in length Medium Approximately 4 4 ...

Page 14: ... The Microstimulator lead should be positioned within the superior medial pterygopalatine fossa PPF using a lead trajectory that is inferior to superior within the PPF This position and trajectory should ensure that at least one electrode is in close proximity to the SPG The Microstimulator Bone Fixation Plate should be positioned sub periosteally over the anterior zygomatic process of the maxilla...

Page 15: ...dure Surgical Introducers 100 and 110 differ in the design of the distal tip Both tips are designed to maintain contact with the posterior maxilla during the procedure However model 110 is designed to promote guidance of the Microstimulator Lead into the PPF if needed Do not apply excessive force to the Surgical Introducer when advancing along the posterior maxilla Puncture of the sinus wall can o...

Page 16: ...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: ...l Introducer when placed properly is located at the pterygomaxillary fissure or just within the pterygopalatine fossa The Lead Blank is used to create an implant path beyond the tip of the Surgical Introducer within the pterygopalatine fossa for the Microstimulator Lead Surgical Introducers include an Insertion Groove Figure 6 along the medial surface Track the Lead Blank along the Insertion Groov...

Page 18: ...n Groove on the Surgical Introducer Using gentle pressure advance the Microstimulator beyond the distal tip of the Surgical Introducer into the pterygopalatine fossa Care should be taken to advance the Microstimulator in the same lead path or trajectory created by the Lead Blank This inferior to superior trajectory with a final distal lead location of the superior medial PPF may be associated with...

Page 19: ...he flat portion of the Microstimulator Body and Bone Fixation Plate are facing the maxillary bone NOTE Confirm the Microstimulator s distal lead position using fluoroscopy or X ray NOTE Fix the Microstimulator to thick dense bone to avoid potential dislodgement NOTE Take care to avoid displacement of the Microstimulator while bending the Bone Fixation Plate NOTE The Bone Fixation Plate can also ac...

Page 20: ...ues Should a clinician decide to remove the Microstimulator in the future it can be removed using standard procedures to open the incision and remove the bone screws from the Microstimulator Bone Fixation Plate J Post Operative Care Observe all standard oral post operative standard of care procedures 12 DISPOSAL Remote Controller Please send any non functional Remote Controllers to Autonomic Techn...

Page 21: ...ce in a residential installation This equipment generates and radiates radio frequency energy and if not installed and used in accordance with the instructions may cause harmful interference to radio communications However there is no guarantee that interference will not occur in a particular installation If this equipment does cause harmful interference to radio or television reception which can ...

Page 22: ...V for power supply lines 1 kV for input output lines Surge IEC 61000 4 5 1 kV differential mode 2 kV common mode 1 kV differential mode 2 kV common mode Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 5 UT 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles 5 UT 95 dip in UT for 5 sec 5 UT 95 dip in UT for 0...

Page 23: ... the equipment should be observed to verify normal operation in the configuration in which it will be used Portable and mobile RF communications equipment can affect the System the following separation distances are recommended Specifications for the Pulsante Microstimulator STIMULATION PARAMETER SPECIFICATION Power Source Resonate Inductive Coupling no finite life Channels Six 6 Channels Waveform...

Page 24: ...nt usage 2 hours from full charge Non operation 3 months from full charge Total Expected Life of Device 18 Months Operating Frequencies 126 kHz 4 kHz Communication Method Radio Frequency RF Specifications for the Pulsante Remote Controller Charger PHYSICAL CHARACTERISTICS SPECIFICATION Remote Controller Charger Size 64 x 40 5 x 29 Height x Width x Thickness mm Case Material 94V0 Polycarbonate Conn...

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