En-English - Integra Miltex padget Instrucciones De Uso

Padgett by Integra
®
Bipolar Instrument Cable
CAUTION: Federal (USA) law restricts this device to sale by or on the order of
a licensed medical professional.
Description
Padgett by Integra Miltex Disposable Bipolar Instrument Cables are
® ® ®
designed to connect an electrosurgical device, such as Bipolar Forceps,
to a compatible electrosurgical generator in electrosurgical procedures to
provide transmission of electrical power from the bipolar electrosurgical
generator to a bipolar instrument. The cables are supplied sterile and are
intended for single use only. Prior to the expiration date, contents are
sterile if the package has not been opened or damaged. Do not re-sterilize
or re-use this device.
Indications for Use
Padgett by Integra Miltex Disposable Bipolar Instrument Cables are designed
to conduct electrical power from the output of a high-frequency electrosurgical
generator to bipolar forceps during general surgical procedures.
Contraindications
None Known
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Warnings
Do not use in presence of flammable liquids or an anesthetic.
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Do not use on patient with pacemakers or other active implants.
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Connect bipolar accessories to the bipolar receptacle only and
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monopolar accessories to the monopolar receptacle only.
Do not attempt to connect or interchange bipolar and monopolar
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accessories and receptacle connections.
Connect the cord to the generator while it is in the "OFF" or
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"STANDBY" mode. Failure to do so may result in injury or electrical
shock to the patient or end user.
Do not re-sterilize or re-use this device. Single use only.
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Precautions
Read the Instructions for Use and keep them in a safe place.
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Use the product only in accordance with its intended use, see
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INDICATIONS FOR USE.
Electrosurgical instruments can pose a significant shock, burn or
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explosion hazard if used improperly, incorrectly or carelessly.
Avoid touching or grounding electrosurgical instruments to non-
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insulated instruments, scopes, trocar sleeves, etc. Test all cables,
instruments, accessories and equipment prior to each use.
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Miltex Disposable
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Adverse events reported while using electrosurgical devices include:
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Instructions for Use
1. Attach the sterile Bipolar cord to the sterile Bipolar instrument,
2. Connect the cord to the generator only while it is in the "OFF" or
3. At the lowest power setting, test the instrument connections by
4. If the generator fails to activate, check the line connection with the
Storage Conditions
Store in a dry, clean and dust-free environment at a moderate temperature
of 41°F (5°C) –104°F (40°C).
Electrosurgical generators used with these devices are designed to
cause destruction of tissue and are inherently dangerous if operated
improperly. Follow all safety precautions and instructions supplied
by the manufacturer of the electrosurgical generator.
Cablings to electrosurgical devices, such as electrodes, should be
placed in a way to prevent any contact to the patient or other cables.
It has to be ensured that the maximum rated voltage of
electrosurgical instruments used in combination with respective
cables does not exceed the maximum rated voltage of the used cable.
Failure to observe these cautions and contraindications may result
in injury, malfunction or other unanticipated occurrences or events
for the operator, and/or the patient.
All persons using such devices should be knowledgeable in the use
and handling of laparoscopic instruments, coagulation equipment,
their accessories and other related equipment.
Do not use the product if it is damaged or defective.
Store products in a dry, clean and safe place.
Inadvertent activation with resultant tissue damage at the wrong
site and/or equipment damage.
Fires involving surgical drapes and other combustible materials have
been reported.
Alternate current pathways resulting in burns where the patient or
physician or assistant is in contact with exposed metal.
Explosions caused by electrosurgical sparking in a flammable gas
environment (i.e. explosive anesthetic gases).
Organ perforation. Sudden massive hemorrhage.
ensuring that the contact pins are fully seated in the cable receptacles.
"STANDBY" mode.
pressing the generator's activating switch.
cable.

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