ArtiCure Isolator Transpolar pen Manual de instrucciones - Página 6

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PRECAUTIONS

•

Read all instructions carefully for the

AtriCure

ASU, Isolator

Pen, ASU Source Switch, and any

auxiliary device being used prior to

using the devices. Failure to properly

follow instructions may lead to

electrical or thermal injury and may

result in improper functioning of the

device.

•

Use of the Pen should be limited to

properly trained and qualified medical

personnel. Proper surgical procedures

and techniques are the responsibility

of the medical professional.

Understanding the proper use of the

Oscor PACE 203 H temporary

pacemaker equipment is also the

responsibility of the medical

professional. Each surgeon must

evaluate the appropriateness of any

procedure based on their own medical

training and experience, and the type

of surgical procedure.

•

Patient and procedure selection is

solely a medical responsibility and the

outcome is dependent on many

variables including patient pathology,

and surgical and perfusion

procedures.

•

Variations in specific procedures may

occur due to individual physician

techniques and patient anatomy.

•

To avoid damage to the device, do not

drop or toss the Pen. If the Pen is

dropped, do not use. Replace with a

new Pen.

•

Do not use the Pen in the presence of

flammable materials.

•

Do not re-sterilize or reuse the Pen.

•

The distal tip of the Pen must be kept

clean of debris during surgery to avoid

loss of power. Before activating the

ASU, inspect the area at the distal tip

of the Pen for foreign matter. Foreign

matter captured on the tip will

adversely affect the ablation.

™

Transpolar

•

The Pen is only compatible with the

AtriCure

ASU and ASB. Use of the

Pen with another manufacturer's

generator may damage the device and

result in patient injury.

•

The ASB should only be used with

FDA approved cardiac pacing and

sensing devices.

•

Do not use the Pen for coagulation or

ablation of veins or arteries.

•

Use caution to avoid trauma to tissues

not within the target area of ablation.

Tissue and/or structures behind the

targeted tissue should be protected

from potential thermal spread.

•

The Pen has an eight hour useful life

that is tracked by the ASU. If you

attempt to plug in a device that has

reached its time limit expiration, the

Pen will no longer function and the

ASU will display a message indicating

that the Pen must be replaced.

•

It is the responsibility of the user to

dispose of this device in accordance

with local regulations.

•

Excessive bending of the malleable

stainless steel shaft will cause the

shaft to harden and may increase the

potential for breakage.