Operating Instructions

• 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 bleed

• Ear or nasal fullness/rhinorrhea (nasal discharge)

• Taste alteration

Possible side effects of SPG stimulation include:

• Discomfort or pain during stimulation associated with paresthesia (a sensation of tingling,

pricking or numbness in the face)

• Runny nose

• Dry eye and tearing

• Conjunctivitis

• Headache

Device complications may include:

• Microstimulator migration or misplacement potentially leading to explant and/or re-implant

• Inability of the Remote Controller to connect with the Microstimulator

• Device malfunction

• Skin and/or bone erosion around the Microstimulator implant site

8. PACKAGING, STORAGE AND HANDLING

• The Remote Controller can be safely stored and operated 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.

• Please treat your Remote Controller with care. It is a sensitive electronic device that may be

damaged by rough handling, including dropping on the ground or being crushed.

• Do not sterilize the Remote Controller.

• Do not store the Remote Controller where it may become wet, as moisture may damage the

package materials or the Remote Controller.

• Do Not use the Remote Controller if the packaging or the Remote Controller looks damaged.

• Do not connect the USB Port to any other electrical device; use only the Charger provided with

the Remote Controller.

• The Remote Controller may feel warm when providing therapy. If experiencing discomfort,

move the Remote Controller away from the face slightly and avoid contact with skin.

• The Remote Controller should not come into contact with skin that is cut or bleeding.