Boston Scientific Active Cord Instrucciones De Uso página 2

Active Cord
Active Cord for use with Monopolar Devices
ONLY
Caution: Federal Law (USA) restricts this device to sale by or on the
order of a physician.
DEVICE DESCRIPTION
The reusable Active Cord is used as an accessory to deliver electrical
current from a controlled power source to a device which delivers the
current to a specified location on the active device.
UPN Generator Compatibility
M00561250 Olympus™ Brand Generator
M00561270 Bovie™ Generators, Valleylab™ Generators, Aspen
Labs™ Generators, ERBE™ Brand Generators,
EndoStat™, EndoStat™ II and Endostat™ III Generators
Contents
(1) Active Cord for use with Monopolar Devices
INTENDED USE / INDICATIONS FOR USE
Active Cord is used to connect the devices to their respective
monopolar generator(s).
Clinical Benefit Statement
Provides a means to deliver energy to an electrosurgical device.
CONTRAINDICATIONS
None known.
WARNINGS
• Inspect the product prior to each use, If damage is found, contact
your Boston Scientific representative. Do not use if damaged.
WARNING: This product is NON STERILE and must be
thoroughly cleaned prior to each use. Sterilization is not
required. End of life is determined by wear and damage due to
use. Always inspect the device for damage or wear prior to use.
Black (K) ∆E ≤5.0
• No modification of this equipment is allowed.
• Avoid HF output settings where the maximum output voltage
may exceed rated accessory voltage.
• This device is not intended to be used in an Oxygen Enriched
Atmosphere or in the presence of explosive gases.
• The maximum voltage rating for this device is 3800V (7600V
peak to peak).
• Do not exceed 75 Watts.
• The rated frequency range for this device is 300 kHz to 1 MHz.
• Do not use this cord with devices rated above the stated voltage
and frequency.
• Interference of HF surgical equipment may adversely influence
operation of other electronic equipment.
PRECAUTIONS
• Prior to use, carefully inspect the unit to verify that neither the
contents nor the package has been damaged in shipment. If
damage is found, contact your Boston Scientific representative.
• This product is intended for use only by or under the supervision
of physicians trained in endoscopic electrosurgical procedures.
• Inspection, handling and use of electrosurgical devices are the
responsibility of the user.
• Connect monopolar accessories to the monopolar receptacle only.
Improper connection of accessories may result in inadvertent
accessory activation or other potentially hazardous conditions.
• Always follow the electrosurgical unit manufacturer's
instructions for operation of the electrosurgical unit to prevent
unnecessary hazard to the operator and/or the patient.
• Consult the endoscope manufacturer's instructions for use
concerning proper grounding of the endoscope.
• Make certain the instructions for use provided with the active
device are followed to perform the procedure.
• Position the Active Cord to avoid contact with the patient or
other leads.
• Store the Active Cord in a location isolated from the patient
when not in use.
• Dispose of product and packaging in accordance with hospital,
administrative and/or local government policy after use.
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