Bolder Surgical
en - CoolSeal™ Generator
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Caution
Set the system volume control at a level that ensures the activation tones can be heard.
Do not turn the activation tone down to an inaudible level. The activation tone alerts the surgical team when the
CoolSeal
™
Generator is delivering RF energy.
Examine all instruments and connections to the system before using. Ensure that the instruments function as
intended. Improper connection may result in arcs, sparks, instrument malfunction, or unintended surgical effects.
A non-functioning CoolSeal
™
Generator may cause interruption of surgery. A backup system should be available
for use.
The use of appliance couplers, i.e., power cords, other than those specified may result in increased emissions or
decreased immunity of the equipment.
Provide as much distance as possible between the CoolSeal
™
Generator and other electronic equipment such as
monitors. Do not cross or bundle electronic devices cords. This generator may cause interference with other
electronic equipment. If interference occurs, relocate the equipment.
Studies have shown that smoke generated during electrosurgical procedures can be potentially harmful to
patients and the surgical team. These studies recommend adequately ventilating the smoke by using a surgical
smoke evacuator or other means.
1
1. U.S. Department of Health and Human Services. National Institute for Occupational Safety and Health (NIOSH). Control of Smoke from Laser/Electric
Surgical Procedures. HAZARD CONTROLS, Publication No. 96-128, September 1996.
Electromagnetic Compatibility
Warning
Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in
improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify
that they are operating normally.
Portable RF communication equipment should be used no closer than 30 cm (12 inches) to any part of the
CoolSeal
™
Generator including cables specified by Bolder Surgical. Otherwise, degradation of the performance
of this equipment could result.
Fire Hazard During Oropharyngeal Surgery
Warning
Verify endotracheal tubes are free from leaks and that the cuff seals properly to prevent oxygen leaks.
Pacemakers and ICDs
Warning
DO NOT USE in patients who have electronic implants such as cardiac pacemakers without first consulting a qualified
professional (e.g., cardiologist). A possible hazard exists because interference with the action of the electronic implant
may occur, or the implant may be damaged.
