Precautions for Use of the NESS H200 Hand Rehabilitation System

• Inflammation in the region of the NESS H200 may be aggravated by motion, muscle activity or pressure from the Orthosis. Use of the device should be temporarily halted until the inflammation clears.
• Caution should be used for patients with suspected or diagnosed epilepsy.
• Specific physician clearance should be obtained prior to use in patients with alteration of normal arterial or venous flow due to local insufficiency, occlusion, arterio-venous fistula for the purpose of hemodialysis, or primary disorder of the vasculature.
• Specific physician clearance should be obtained when there is a structural deformity or placement of metal implant in the area to be stimulated.
• Specific physician clearance should be obtained prior to use in patients with implantable cardiac defibrillators (ICDs); those patients cleared to use the NESS H200 should be followed closely by the relevant physician to ensure continued proper functioning of their ICD devices.
• The safety of the NESS H200 during pregnancy has not been established.
• Skin problems in areas of contact with the Orthosis may be aggravated by use of the NESS H200.
• The NESS H200 should be turned OFF before removing or replacing electrode pads.
• The NESS H200 should be kept out of the reach of children.
• The NESS H200 control unit is splash proof. However, it should be protected from any contact with water, such as dampness from sinks, bathtubs and shower stalls, from weather such as rain and snow, or from any other source of water. Always keep the control unit at a safe distance while wetting the electrode pads.
• Do not leave the NESS H200 stored in a car in hot weather where the temperature may exceed the recommended storage temperature and could cause damage to the device.
• Stimulation should not be applied over areas of "natural reflexes" (e.g. carotid sinus, heart, parasympathetic nerves, laryngeal muscles, phrenic nerve).
• Stimulation should not be applied over fixed contracture(s).
• If stimulation causes cardiac irregularity, stop stimulation.
• Patients should not drive or operate heavy or dangerous machinery while using the device.
• Any noxious stimulation can trigger autonomic dysreflexia in patients with spinal cord injury at the T6 level and above (acute hypertension and bradycardia).
• Caution should be taken when using very strong electrical stimulation over superficial bony prominences.
• Caution should be used for patients with implanted intrathecal/intravascular drug delivery systems. During initial trials with the H200, clinicians should monitor carefully patients on intraspinal/intravascular therapy for any new neurological or other medical signs or symptoms. Those clinicians should be advised to inform patients of the signs and symptoms of drug underdose or overdose. Clinicians and patients also should be advised to follow programming guidelines and precautions provided in the relevant drug delivery systems' product manuals.

Should any technical problem occur, patients should contact their clinician or Bioness Inc. No attempt should be made by a patient to repair the NESS H200. Should any clinical problem occur, patients should contact their clinician and the clinician should then contact Bioness Inc.