•
Type BF Equipment
• Internally powered equipment
• Continuous operation
• Read Instruction Manual
CAUTION
• US Federal Law restricts this device to sale by, or on order of, a physician or any other
practitioner licensed by the law of the state in which he or she practices to use or order the use
of this device.
WARNING
• Do not operate Active Sensors within 10 feet of an operating cellular phone, similar radio
transmitting device, other powerful radio interference producing sources such as arc welders,
radio thermal treatment equipment, x-ray machines, or any other equipment that produces
electrical sparks.
• All encoders are totally isolated from line (110 or 220VAC) power due to battery operation and
fiber optic connections to computers. However, many hospitals and the FDA require that
computers, printers and any other equipment used with medical devices be electrically isolated
from line voltage to UL or CSA medical safety standards.
• The PC used with ProComp Infiniti must be placed outside the patient/client environment
(more than 3 meters or 10 feet) or the PC must comply with EN60601-1-1 (system safety).
• After use, the Disposable Electrodes may be a biohazard. Handle, and when applicable,
dispose of these materials in accordance with accepted medical practice and any applicable
local, state and federal laws and regulations.
• Reusable electrodes present a potential risk of cross-infection especially when used on
abraded skin, unless they are restricted to a single patient or sterilized between patients. If
sterilizing electrodes, employ only gas sterilization.
• Radiated radio frequency electromagnetic fields can cause performance degradation in the
MyoScan-Pro EMG sensor. In the worst case, an RF field strength of 22mV/M can cause an
increase of 1μV in the signal reading from a MyoScan-Pro sensor. Be sure to keep in mind
that a very relaxed muscle should provide an EMG reading of approximately 1-3μV.
• Explosion Hazard; Do not use in the presence of a flammable anesthetic mixture with air, or
with Oxygen or Nitrous Oxide.
• Not to be immersed in water.
• Take care in arranging patient and sensor cables to avoid risk of patient entanglement or
strangulation.
• The operator is responsible for ensuring the safety of any devices controlled or triggered by
Infiniti equipment or software, or by any software or hardware receiving data from Infiniti
equipment. Infiniti equipment must not be configured or connected in such a way that failure in
its data acquisition, processing or control functions can trigger patient feedback stimulus that
poses an unacceptable level of risk.
• Use of any equipment in a biofeedback context should be immediately terminated upon any
sign of treatment-related distress or discomfort.
• Not to be connected to a patient undergoing MRI, Electro surgery or defibrillation.
ATTENTION
• Sensors damaged by static electricity are not covered under warranty. To prevent static
discharge from damaging the sensor and/or encoders, use anti-static mats or sprays in your
working area. A humidifier may also be used to prevent static environments by conditioning
hot, dry air.
• Do not apply any electrode gel or equivalent directly on the sensor snaps. Always use
electrodes as a medium between the sensor and the client.
• Not for diagnostic purposes, not defibrillator proof, not for critical patient monitoring.
• To prevent voiding warranty by breaking connector pins, carefully align white guiding dot on
sensor plug with slot on sensor input.
• Sharp bends or winding the fiber optic cable in a loop smaller than 4 inches (10cm) may
destroy the cable.
• A fiber optic cable not fully pushed into its receptacle may cause the unit not to operate; make
sure that both ends of the cable are fully inserted into their receptive jacks and the nut is
ProComp Infiniti Hardware Manual
4
To Next Page