CareFusion Snowden-Pencer Manual Del Usuario página 5

Caution: Federal (U.S.A.) law restricts this device to sale by or
on the order of a physician.
Catalog Numbers: All reusable product codes covered by these
instructions for use are listed in the Appendix.
Device Description
Snowden-Pencer™ Micro-Laparoscopic 3 mm Instruments
are reusable insert assemblies with elongated narrow shafts
suitable for surgical manipulation through small incisions.
Multiple versions of these instruments are available to
accommodate a range of tasks and preferences.
Indications for Use
All products covered by the following Indications for Use are
listed in the Appendix. The Snowden-Pencer Micro-Laparoscopic
3 mm Instruments are indicated to be used in laparoscopic
and other minimally invasive procedures for cutting, clamping,
grasping, suturing and dissecting and to allow high frequency
monopolar cutting and coagulation.
Explanation of Symbols
Refer to the BD Symbols Glossary for symbol definitions at
www.bd.com/symbols-glossary.
Operating Conditions
Insert assemblies shall be used in ambient environmental
conditions during normal operation. Specific environmental
condition parameters of use are listed in the cleaning and
sterilization sections.
Handle Compatibility
Insert assemblies are intended to be used exclusively with
Snowden-Pencer Ergonomic Modular reusable handles
(SP94, SP95, SP96, SP97, SP98, and SP99).
Electrode Cable Compatibility
Insert assemblies indicated for monopolar electrosurgical
use are listed in the Appendix. These insert assemblies are
compatible with the FDA-cleared Unipolar Bovie Cord with
universal plug (88-9199) or equivalent.
Generator Compatibility
Insert assemblies indicated for monopolar electrosurgical
use are listed in the Appendix. These insert assemblies are
only compatible with FDA-cleared high frequency monopolar
electrosurgical generators: ValleyLab™ Force™ 2 PC, ConMed
System 5000™, and ConMed
generator manual for more detailed information on using this
insert assembly under various modes of operation.
Neutral Electrodes Compatibility
Insert assemblies indicated for monopolar electrosurgical
use are listed in the Appendix. These insert assemblies are
only compatible with FDA-cleared neutral electrodes: ConMed
Reusable Dispersive Electrode (Product Number 60-0136-001).
Refer to the generator manual for more detailed information on
using this insert assembly under various modes of operation.
For Outside United States Market
All Snowden-Pencer Micro-Laparoscopic 3 mm Instruments
indicated for monopolar electrosurgical use are listed in
the Appendix. These insert assemblies are compatible with
IEC compliant high frequency monopolar electrosurgical
generators. Refer to the generator manual for more detailed
information on using this insert assembly under various
modes of operation.
How Supplied
Insert assemblies are packaged as non-sterile. Cleaning and
sterilization must occur prior to use.
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