Indications & Risk of the Checkpoint Head and Neck
The Checkpoint Head and Neck is a single-use, sterile device intended to provide electrical stimulation of exposed motor nerve or muscle tissue to locate and identify nerves and to test nerve and muscle excitability.
Head & Neck Surgical Nerve Stimulator/Locator
Patented (US) – www.checkpointsurgical.com/patents Ⓓ (US)
INDICATIONS FOR USE:
The CHECKPOINT® Head & Neck Stimulator is a single-use, sterile device intended to provide electrical stimulation of exposed motor nerves or muscle tissue to locate and identify nerves and to test nerve and muscle excitability.
Do NOT use this Stimulator when paralyzing anesthetic agents are in effect, as an absent or inconsistent response to stimulation may result in inaccurate assessment of nerve and muscle function.
- Do NOT apply stimulation across the patient’s chest because the introduction of electrical current into the chest may cause rhythm disturbances to the patient’s heart.
- Do NOT leave Stimulator unattended in the surgical field.
- Do NOT use Stimulator in the presence of flammable anesthetics.
- Do NOT use this Stimulator in patients with implanted electronic devices. Stimulus current near such devices may cause them to malfunction.
- Do NOT use in cerebrospinal fluid, brain, meninges, or spinal cord.
- Do NOT use the Stimulator while delivering electrocautery. Electrocautery may interfere with or damage the Checkpoint Head & Neck Stimulator or cause injury.
- Use of a tourniquet may reduce nerve and muscle excitability distal to the tourniquet. If a decrease in nerve or muscle response to stimulation is observed, it may be necessary to take down the tourniquet and allow time for re-perfusion before testing with Checkpoint.
- Single use only. Once turned ON, the Stimulator will not turn OFF and will remain operational for approximately four (4) hours.
- Use the Stimulator at 0.5mA initially and increase the amplitude as needed.
- Do NOT bend the probe or apply excessive pressure where the probe enters the nose cone. Do NOT use the Checkpoint Head & Neck Stimulator as a dissecting tool or for any other purpose not specified in these Instructions for Use.
- The needle return electrode may cause stimulation. Place the needle return electrode in an area away from excitable tissue and away from the stimulation area to avoid confusion.
- Do NOT submerge or saturate the Checkpoint Head & Neck Stimulator with fluid.
- The Stimulator may interfere with patient monitoring equipment in the operating room while stimulating.
- Portable and mobile Radio Frequency (RF) communications equipment can interfere with the Stimulator. Do not use such equipment while delivering stimulation.
- The Stimulator is not likely to cause any interference in nearby electronic equipment through Electromagnetic Interference (EMI) (complies with CISPR 11, Type B). For additional information on Electromagnetic Interference contact NDI Medical.
- Be aware that using the device in the vicinity of certain nerves can have systemic effects (e.g. bradycardia, hypotension, laryngospasm).
The Checkpoint Head & Neck Stimulator is an adjunctive tool for locating nerves and testing nerve and muscle excitability. It is not intended to replace good surgical techniques in locating and dissecting tissue. The surgeon is ultimately responsible for identifying exposed motor nerves and tissue.