Safety Information - Spectros T-Stat 2.0 User Manual

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T-STAT 2.0 User Manual
A. Safety Information
NOTE: Federal Regulations in the United States restrict the sale of this device to or on the order of
licensed medical practitioners.
Warnings
WARNING: Explosion hazard. Do not operate the monitor in the presence of flammable gases or
anesthetics, such as high concentrations of oxygen or nitrous oxide.
WARNING: Electric shock hazard. The monitor's cover is to be removed only by qualified service
personnel. There are no user-serviceable parts inside.
WARNING: Use only the medical-grade AC power cord provided by the manufacturer. If in doubt
about the integrity of the mains supply connection, cease the operation of the monitor.
WARNING: Do not look directly into light source for extended periods of time.
WARNING: T-Stat sensors are designed for single use only and may not be re-used. Do not
autoclave or gas-sterilize any of the T-Stat sensors.
WARNING: Use only T-Stat sensors in conjunction with the T-Stat monitor. Connecting other
sensors may result in damage to the T-Stat monitor, or compromise its safety or performance.
WARNING: Do not autoclave, gas-sterilize, or immerse the T-Stat
monitor. This may create an
®
electric shock hazard, or damage internal components.
WARNING: Do not connect any accessories to the USB port on the rear panel of the monitor when the
system is in use on a patient other than the approved AT&T or Verizon modems.
WARNING: When monitoring on neonates or infants, check site every 4 hours for pressure necrosis
and change site every 24 hours.
WARNING: Reuse of Sterile Sensors can result in infection due to cross contamination.
WARNING: Sensors are designed for single use. Reuse can result in intermittent operation due to
contamination of the receiving connection in the T-Stat.
WARNING: When monitoring on adults, check site every 12 hours for pressure necrosis and change
site every 24 hours.
WARNING: Lithium Battery: Replacement by inadequately trained personnel could result in a HAZARD
(such as excessive temperatures, fire or explosion).
Page 4 of 44
Rev B
Spectros Medical Devices Inc.

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