Ethicon Endo-Surgery ULTRACISION HARMONIC SCALPEL Generator 300, User Manual

System Warnings and Precautions

•

Minimally invasive procedures should be performed only by persons having adequate training and
familiarity with minimally invasive techniques. Consult medical literature relative to techniques,
complications, and hazards prior to performance of any minimally invasive procedure.

•

Minimally invasive instruments may vary from manufacturer to manufacturer. When minimally invasive
instruments and accessories from different manufacturers are employed together in a procedure, verify
compatibility prior to initiation of the procedure. 

•

A thorough understanding of the principles and techniques involved in laser, electrosurgical, and ultrasonic
procedures is essential to avoid shock and burn hazards to both patient and medical personnel and damage
to the device or other medical instruments. Ensure that electrical insulation or grounding is not
compromised. Do not immerse electrosurgical instruments in liquid unless the instruments are designed and
labeled to be immersed.

•

Safe and effective ultrasonic surgery is dependent not only upon equipment design, but also, to a large
extent, upon factors under control of the operator. It is important that the instructions supplied with this
equipment be read, understood, and followed in order to enhance safety and effectiveness.

•

As with all energy sources (Electrosurgery, Laser, or Ultrasound), there are concerns about the carcinogenic
and infectious potential of the by-products, such as tissue smoke plume and aerosols. Appropriate measures
such as protective eyewear, filtration masks, and effective smoke evacuation equipment should be used in
both open and laparoscopic procedures.

•

To avoid user or patient injury in the event that accidental activation occurs, the U

LTRA

C

ISION

H

ARMONIC

S

CALPEL

instrument blades should not be in contact with the patient, drapes, or flammable materials while

not in use. During prolonged activation in tissue, the instrument blade, clamp arm and distal end of the shaft
may become hot. Avoid unintended blade contact with tissue, drapes, surgical gowns, or other unintended
sites after activation.

•

To avoid user or patient injury, the U

LTRA

C

ISION

H

ARMONIC

S

CALPEL

Generator should not be used prior to

biomedical evaluation if it shows signs of damage or is suspected of being dropped or having fluids spilled
on it.

•

After removing the instrument, examine the tissue for hemostasis. If hemostasis is not present, appropriate
techniques should be used to achieve hemostasis.

•

Products manufactured or distributed by companies other than Ethicon Endo-Surgery, Inc. may not be
compatible with the U

LTRA

C

ISION

H

ARMONIC

S

CALPEL

system. Use of such products may lead to

unanticipated results and possible injury to the user or patient.

•

The U

LTRA

C

ISION

H

ARMONIC

S

CALPEL

system, including the hand piece, is not Magnetic Resonance safe

and is not Magnetic Resonance compatible.

•

To reduce the risk of interference, electrosurgical systems and the U

LTRA

C

ISION

H

ARMONIC

S

CALPEL

system

should be plugged into separate electrical power circuits. Locate the U

LTRA

C

ISION

H

ARMONIC

S

CALPEL

system, including the hand piece cable, at least 3 ft. (approximately 1 m) from electrosurgical systems
and their hand piece (e.g., pencil) cables.

•

Equipment not suitable for use in the presence of a flammable anesthetic mixture with air or with oxygen or
nitrous oxide. It is possible to create sparks by hitting other metal instruments. Sparks may ignite
flammable gases such as bowel gas.

•

The U

LTRA

C

ISION

H

ARMONIC

S

CALPEL

system must be operated within the required ambient operating

conditions. Refer to Chapter 8 – System Specifications for requirements.

•

To prevent overheating during use, ensure that the air vents found on the generator’s bottom and back
panels are not blocked and that they allow adequate clearance from obstructions to allow air to flow freely
through the generator enclosure. Avoid placing the generator on a soft surface.

•

Verify that the outlet voltage correctly corresponds to the generator’s requirements (see Chapter 8 – System
Specifications). Connection to an improper power supply may result in damage to the generator and risk of
shock or fire hazard.

•

The U

LTRA

C

ISION

H

ARMONIC

S

CALPEL

system includes components that are shipped non-sterile (e.g. hand

piece, hand switching adaptor, adaptors, and blade wrench). Sterilize products as required before beginning
system setup. Refer to individual package inserts for cleaning and sterilization instructions.

•

To avoid user or patient injury, ensure that the instrument is clear of other instruments, drapes, the patient,
or other objects before pressing TEST and during the system check. Safety measures (in accordance with
hospital protocol) taken in the presence of aerosols should be in effect during the system check and while in
Test mode.

Chapter 7 – Warnings and Precautions

21

GEN04