Boston Scientific 5100 Instrucciones De Uso página 2

Adaptor Cable Bipolar
ONLY
Caution: Federal Law (USA) restricts this device to sale by or on the
order of a physician.
DEVICE DESCRIPTION
The reusable Adaptor Cable Bipolar is used as an accessory to
deliver electrical current from a controlled power source (generator)
to the Habib™ EndoHPB Catheter.
UPN Generator Compatibility
5100 KLS MARTIN MAXIUM™, ERBE VIO™ 3,
Olympus™ ESG-100
5420 ERBE ICC 200™/300/350, ERBE VIO
200D/300D/200S/300S, Genii™ GI 4000
5700 ERBE ICC 200/300/350, ERBE VIO
200D/300D/200S/300S, ERBE VIO 3
Contents
(1) Adaptor Cable Bipolar
INDICATIONS FOR USE / INTENDED USE
Adaptor Cable Bipolar is used to connect the Habib EndoHPB
Catheter to the respective generator(s) listed in the above table.
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: Unless otherwise indicated, 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.
• 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 200V.
• The maximum frequency for this device is 480 kHz.
• 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.
Black (K) ∆E ≤5.0
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