UNLOCKING POTENTIAL | TERUMOBCT.COM Page 3 of 15 Version 1.0 Rev 02/2021
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1. Warnings and Cautions
The general safety information in the Operator’s Manual is for operating personnel. Specific notes, cautions, and
warnings are found throughout this document where applicable. Please read the Operator’s Manual carefully before
using this device.
Note! Identifies conditions that should be noted carefully.
Caution! Identifies conditions that could result in damage to the device.
Warning! Identifies conditions that could result in personal injury or loss of life.
Warning! T-SEAL III must be used in compliance with all specifications and operational procedures listed in the
Operator’s Manual.
Warning! T-SEAL III must be used under the control of trained personnel.
Warning! Follow the Operator’s Manual while operating T-SEAL III.
Warning! Cables and accessories other than those specified may result in increased emission or decreased
immunity of the equipment or system. Only accessories designed for use with T-SEAL III should be
used.
Warning! The device should not be used adjacent to or stacked with other equipment. If adjacent or stacked use
is necessary, verify normal operation of the device in the configuration in which it will be used.
Warning! If any of the components of T-SEAL III are exposed to blood, they must be cleaned with an
appropriate disinfectant solution.
Warning! The device must always be connected to a grounded outlet and with an appropriate alternating current
mains source, 100 or 240 V ~.
Warning! The device emits RF energy during the sealing procedure and movement of the electrode.
Warning! T-SEAL III is not intended for use in an oxygen-rich environment.
Warning! T-SEAL III is not intended to be used with flammable anesthetics or in conjunction with flammable
agents.
Caution! ELECTROMAGNETIC INTERFERENCE REGULATIONS
This device fulfills EN 60601-1-2:2014 Standards (Electromagnetic Compatibility). Nevertheless, this device uses
radiofrequency (RF) energy to generate heat while the tube is being sealed and can affect other Medical Electrical
Equipment. See Table 1 for guidance. If installation and use are not performed in accordance with the Operator’s
Manual, it could cause interference with radio, television, and instrument communications.