Training Of Surgical Implantation; Description Of Laparoscopic Surgical Procedure - Synapse NeuRx Handbuch

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· At this time, there is insufficient clinical data to determine safety in implanting

patients with cardiac pacemakers, therefore, patients should not be implanted with

this device if they have a cardiac pacemaker or other implanted electrical device

· This product should not be used by patients with suspected or real heart problems

or who have epilepsy

· The safety of this device in use during pregnancy is unknown

· The long-term effects of electrical stimulation of the diaphragm are unknown

· It is possible that stimulation from the diaphragm pacing system could stop either

due to electrode breakage, cable disconnection, or stimulator failure. If one of

these happens, breathing will stop. Without prompt attention, this could result in

permanent disability or death. This risk is reduced by using back-up electrodes and

sounding an alarm whenever the stimulator detects improper operating conditions.

· There is a risk of aspiration when using the device. While becoming used to the

stimulation and timing, it is recommended that a one-way speaking valve on the

tracheostomy be used while eating or drinking when on the pacing device. It is also

recommended to use the one-way speaking valve while sleeping to avoid upper

airway obstructions.

· Patients may experience increased spasms with the stimulation while their body

becomes used to the stimulation. This typically subsides within a few days of use.

13.0 TRAINING OF SURGICAL IMPLANTATION

New surgeons will be proctored in the implantation of the NeuRx DPS

qualified, trained surgeon. To be considered for training, the new surgeon must

be credentialed for laparoscopic surgery at their institution. The training procedure

will, minimally consist of the qualified trainer proctoring from outside of the surgical

field, in the trainee's operating room. The trainer will review the procedure, using

this manual, and the patient information to assure that appropriate candidate

selection has been made. Specific precautions will be reviewed, including the

identification of a capnothorax with preventive measures and steps to resolve, prior

to the procedure. Any peri-operative morbidity, mortality, or device malfunctions

will be reported according to the FDA Medical Device Reporting (MDR) procedures

and reviewed by Synapse Biomedical. Upon completion of training the trainee

may request additional onsite proctoring or the trainer may identify that additional

proctoring is necessary. The training will be documented on a Surgeon Training

Memo, to be kept on record at Synapse Biomedical.

WARNING: Visually inspect all STERILE barriers before use. Do NOT use the

device if the sterile barrier is open, damaged or broken.

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