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The TOF3D is used to objectively monitor the level of neuromuscular transmission by measuring muscle contraction following stimulation. The TOF3D can also be used as a peripheral nerve stimulator (without the objective measuring function) for subjective monitoring.

The TOF3D is intended for use by specialists, anesthetists and nurses with specialization in anesthesia care.

Patients:
The device is intended for use for adolescents greater than 18 through 21 years of age, and adults.

Excluded operating environment:
The device is not designed to be used outdoors, in homecare, ambulances, helicopters, aircraft, submarines, boats, hyperbaric chambers, explosive, flammable and oxygen rich environment or environment with sources of intense electromagnetic disturbances. (e.g. Radio Frequency (RF) shielded room of magnetic resonance imaging equipment, electrophysiology laboratories or areas where short or micro wave therapy equipment is used)

The TOF3D is a neuromuscular transmission (NMT) monitor used for objectively monitoring the neuromuscular transmission of patients during surgery or in the intensive care unit. It is intended to be used by specialists, anesthetists and nurses with specialization in anesthesia care. The TOF3D can also be used as a peripheral nerve stimulator (without the objective measuring function) for subjective monitoring. The TOF3D is battery powered and uses 4 x 1.5 V AA batteries. The TOF3D has no external power supply.

The neuromuscular transmission is monitored by measuring muscle contraction following stimulation. The TOF3D can perform several different modes of electrical stimulation in accordance with usual clinical practice:

• TOF (Train Of Four)
• PTC (Post Tetanic Count)
• TET (Tetanic Stimulation) 50 Hz or 100 Hz
• DBS (Double Burst Stimulation) (3.2 / 3.3)
• ST (Single Twitch) 0.1 Hz and 1 Hz

The TOF3D uses acceleromyograph (AMG) or mechanomyography (MMG) measurement for recording of evoked muscle responses. By using acceleromyograph (AMG) the acceleration of e.g. the thumb is measured with a three-dimensional acceleration sensor to obtain the muscle force according to the second law of Newton. Different locations for monitoring by using the AMG sensor are for instance the ulnar nerve/adductor pollicis muscle, the posterior tibial nerve/flexor halluces brevis muscle and the facial nerve orbicularis oculi muscle or corrugator supercilii muscle. Mechanomyography (MMG) and the corresponding Mechanomyography sensor (MMG) TOF3D can only be used by stimulating the ulnar nerve and the corresponding measurement of the thumb force with a pressure sensor. All results are shown on the LCD display of the device.

With the optional temperature sensor or with the integrated temperature sensor in the Mechanomyography sensor (MMG) TOF3D the TOF3D is capable to measure the skin surface temperature (no physiological parameter) during its use.

Based on the force of contraction resulting from stimulation, it is possible to draw conclusions on the level of neuromuscular transmission which shall aid qualified medical staff to maintain the proper level of neuromuscular block and to determine the level of recovery from neuromuscular block.

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