Programming Manual

• 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. Personnel Training

Physicians performing the Microstimulator implant should be experienced in the surgical

anatomy of the mid-face, anterior skull base, pterygopalatine fossa and infratemporal fossa.

Physicians should be trained on the use of all components of the Pulsante® SPG

Microstimulator System and the contents of this Manual before initiating the procedure.

B. Planning for Surgery

Implant laterality is selected based on the patient’s predominant side of headache pain.

Choose an appropriate Microstimulator size based on the laterality. Using a pre-operative

facial bone/paranasal sinus Computed Tomography (CT) scan to complete a 3D rendering of

the surgical anatomy and subsequent surface measurement 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 cm in length

• Long - Approximately 5.2 cm in length

• Extra-Long - Approximately 6.0 cm in length

The following items are supplied by Autonomic Technologies:

• Microstimulator

• Surgical Tools

• 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:

▪ Midface periosteal elevator

▪ Craniomaxillofacial bone kit including self-tapping bone screws (1.8 mm diameter

and 4mm length) and the associated driver

• Sterile wand cover/ultrasound probe cover, or other sterile cover as appropriate for

intra-operative use of the Remote Controller

• Sterile plastic basin with sterile saline

• Imaging equipment, such as fluoroscopy.

Observe all oral pre-operative standard-of-care procedures.