ArtiCure Isolator Transpolar pen User manual

Isolator™Transpolar™pen
Instructions for Use
(Page 2)
For use with the following
Isolator™Transpolar™pen models:
MAX5 -A000625
MAX1 - A000163

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Isolator™Transpolar™pen
Instructions for Use
DESCRIPTION
The Isolator™Transpolar™pen System is comprised of the AtriCure®Ablation and Sensing
Unit (ASU), Isolator™Transpolar™pen (Pen) or Isolator™Long Pen TT (Pen), Footswitch,
ASU Source Switch. The Pen is a single patient use electrosurgical instrument designed for
use only with the ASU and ASU Source Switch (ASB). The Pen is used to ablate cardiac
tissues and as a surgical pacing and mapping tool.When the Pen is connected to the ASU,
the ASU provides the bipolar radiofrequency (RF) energy flowing between both electrodes
of the Pen. The Operator controls the application of this RF energy by pressing the
Footswitch. When the Pen is connected to an auxiliary pace, sense, or stimulation device;
the Pen is designed to provide temporary pacing or monitoring. The ASB is a passive
device accessory that allows switching between the ASU and an external pacing/monitoring
device, such as the Oscor PACE 203 H temporary pacemaker.
ISOLATOR™TRANSPOLAR™PEN ILLUSTRATION AND NOMENCLATURE
1. Distal Tip
5. Cable
2. Electrodes
6. Connector
3. Malleable Shaft
7. Alignment Arrow
4. Handle
2
2
1

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ISOLATOR™LONG PEN TT ILLUSTRATION AND NOMENCLATURE
1. Distal Tip
5. Handle
2. Electrodes
6. Cable
3. Malleable Shaft
7. Connector
4. Rigid Shaft
8. Alignment Arrow
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2
1
3
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INDICATION FOR USE
•The Isolator™Transpolar™Pen is a
sterile, single use electrosurgery
device intended to ablate cardiac
tissue during cardiac surgery using
radiofrequency (RF) energy when
connected directly to the ASU or to the
ASU Source Switch in Ablation mode.
•When the Pen is connected to the
ASU Source Switch in Auxiliary mode,
it may be used for temporary cardiac
sensing, recording, stimulation, and
temporary pacing during the
evaluation of cardiac arryhthmias.
CONTRAINDICATIONS
•The device is not intended for
contraceptive tubal coagulation
(permanent female sterilization).
•Do not ablate directly on cardiac
valves.
POTENTIAL COMPLICATIONS
Possible complications related to the
creation of spot or linear lesions in cardiac
and soft tissues are:
•Tissue perforation
•Postoperative embolic complications
•Extension of extracorporeal bypass
•Perioperative heart rhythm disturbance
(atrial and/or ventricular)
•Pericardial effusion or tamponade
•Injury to the great vessels
•Valve leaflet damage
•Conduction disturbances
(SA/AV node)
•Acute ischemic myocardial event

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WARNINGS
•Do not touch the electrodes of the Pen
while activating the ASU. Touching the
Pen electrodes during ASU activation
could result in an electrical shock or
burn to the operator.
•Do not touch the electrodes of the Pen
to metal staples or clips, or to sutures
while activating the ASU. This may
damage the Pen or tissue, or result in
an incomplete ablation.
•Do not use abrasive cleaners or
electrosurgical tip cleaners to clean
debris from the Distal Tip. Do not turn
on ASU while cleaning the device.
Use of abrasive cleaners or
electrosurgical tip cleaners can
damage the electrodes and result in
device failure. Use saline-soaked
gauze for cleaning debris.
•Do not immerse the Pen in liquids as
this may damage the device.
•To avoid shock/burn hazards, always
wear the appropriate surgical gloves
when using the Pen and ASU.
•To avoid shock/burn hazards, always
remove the Pen from the patient
during defibrillation.
•No representation or warranty is made
that failure or cessation of function of
the device will not result in an adverse
event or that medical complication
(including tissue perforation) will not
follow the procedure, or that the use of
the device will in all cases restore
adequate cardiac function.
•To avoid the risk of patient infection,
inspect the product packaging prior to
opening to ensure that the sterility
barrier is not breached. If the sterility
barrier is breached, do not use the
Pen.
•The pen device is intended for single
use only. Do not RESTERILIZE.
Resterilization may cause loss of
function or injury to patient.
•Use only connecting cables and
auxiliary device identified in this
Instruction for Use to avoid risk of
patient injury, operator injury, or
equipment damage.
•Do not allow the connectors of the Pen
to get wet. Wet connectors may affect
the device performance.
•Read auxiliary device manual and
observe warnings. The Pen can be
used with a temporary pacemaker.
•Do not connect the ASB auxiliary
device cable to supply mains (line
voltage) operated equipment without
verifying isolation of the connected
equipment to EN60601-1-1. Supply
mains operated equipment may
introduce dangerous leakage currents
into the heart
•An auxiliary device may have an
adverse effect on nearby radio or TV
transmissions. There may also be
cases when nearby electrical
appliances adversely influence the
auxiliary device, causing data errors or
malfunction.

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PRECAUTIONS
•Read all instructions carefully for the
AtriCure®ASU, Isolator™Transpolar™
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.
•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.

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INSTRUCTIONS FOR USE
Cardiac Ablation Mode
1. Using sterile technique, remove the
Pen from its packaging. With the
Connector Alignment Arrow symbol in
the 12 o’clock position, push the
Connector into the Pen receptacle on
the front of the ASU or ASB. Verify
that the connections between the Pen
and the ASU are secure. If the
connections are loose, do not use the
Pen. Inspect the Cable and do not use
the Pen if the cable is frayed or the
insulation is damaged.
2. Under direct visualization, place the
distal tip against the targeted cardiac
tissue. Assure both electrodes are in
contact with targeted tissue.
3. Painting ablation technique:
3.1. Maintaining visualization, move
the distal tip gently across the
targeted cardiac tissue.
3.2. While maintaining continuous
contact between the tissue and
the electrodes, move the device
continuously in an oscillating
manner at a rate of
approximately 1 cm/sec.
Painting Lesion Depth*
*Data was obtained from ablations performed on
excised bovine myocardium and represent 95%
confidence intervals. Results may vary based on
live tissue properties.
4. Stamping ablation technique:
4.1. Apply constant firm pressure to
the tissue without movement.
Maintain full contact of the
electrode surface with the tissue.
A stamping lesion is
approximately 8 mm x 6 mm.
4.2. If creating longer linear lesions
with the Stamp technique,
overlap the contiguous ablations
by 50% to ensure a continuous
and complete lesion.
Stamp Lesion Depth*
10
seconds
15
seconds
3.3 - 3.8 mm
3.8 - 4.4 mm
*Data was obtained from ablations
performed on excised bovine myocardium
and represent 95% confidence intervals.
Results may vary based on live tissue
properties.
5. Press the Footswitch to activate the
ASU.
6. When the Footswitch is pressed, the
ASU will emit an audible tone
indicating that current is flowing
between the electrodes located at the
distal tip of the Pen and through the
tissue.
7. Inspect the surgical area to ensure
adequate ablation.
8. Between ablations, wipe the distal tip
clean with a saline-soaked gauze pad.
Important: For optimal performance,
keep the Pen electrodes clear of
coagulum. To ensure the electrodes
are clear of coagulum:
8.1. Use saline-soaked gauze to
clean the electrodes after each
ablation. The coagulum is much
easier to remove within the first
several seconds after ablation.
In a brief period of time, the
coagulum may dry, making
removal of coagulum more
difficult.
8.2. Check both electrodes before
each ablation to ensure that the
20 seconds
2 cm oscillation
2.0 –4.0 mm
Insert with Connector Alignment
Arrow at the 12 o’clock position

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gold of the electrode is visible
and coagulum is removed.
8.3. If the Pen is idle between
ablations, place the Pen distal
tip onto saline-soaked gauze to
prevent any coagulum not
cleaned off the electrodes from
drying.
9. Repeat ablation if necessary.
10. Upon completion of the surgical
procedure, disconnect the Pen from
the ASU/ASB and discard the Pen
after use. Follow local governing
ordinances and recycling plans
regarding disposal or recycling of
device component.
INSTRUCTIONS FOR USE
Pacing and Mapping Mode
1. Inspect the package and product to
ensure the expiration date has not
passed and no damage occurred to
the product during shipping and
handling.
2. Using sterile technique, remove the
Pen from its packaging.
3. With the Connector Alignment Arrow
symbol in the 12 o’clock position, push
the Connector into the Pen receptacle
on the front of the ASB. Verify that the
connections between the Pen and the
ASB are secure. If the connections are
loose, do not use the Pen. Inspect the
Cable and do not use the Pen if the
cable is frayed or the insulation is
damaged.
4. A cable with standard 0.080 inch pin
tip plugs is provided with the ASB to
connect to the auxiliary device. The
end of the cable with the single pin tip
plug is connected to the ASU Source
Switch. The end of the cable with dual
pin tip plugs is connected to the
auxiliary device.
5. Turn on the temporary pacing or
sensing equipment and ensure proper
connections to validate electrical
continuity. For detailed instructions
refer to temporary pacemaker manual.
6. Settings and procedures for the
auxiliary device are determined
according to the instructions for use
provided with the auxiliary device. Set
auxiliary device to atrial asynchronous
mode (sensing disabled or increased
to maximum value).
Note: The Pen will pace when the auxiliary
device is in the ON position.
Insert with Connector Alignment
Arrow at the 12 o’clock position

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7. Identify and expose the sites for
pacing and sensing using standard
surgical techniques. Under direct
visualization, place the electrodes
against the targeted tissue. Assure
both electrodes are in contact with
targeted tissue.
8. Ensure the pacing is only on when the
end effector is in contact with the
targeted tissue. The device will pace
when the auxiliary device pacing is on.
9. For sensing (mapping), place the distal
tip onto the targeted tissue to display
the electrogram (EGM).
10. Upon completion of the surgical
procedure, disconnect the Pen from
the ASB and discard the Pen after
use. Follow local governing ordinances
and recycling plans regarding disposal
or recycling of device component

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HOW SUPPLIED
The Isolator™Transpolar™pen is supplied
as a STERILE instrument and is for single
patient use only.
Sterility is guaranteed unless the package is
opened or damaged. Do not resterilize.
RETURN OF USED PRODUCT
If for any reason this product must be
returned to AtriCure®, Inc., a return goods
authorization (RGA) number is required
from AtriCure®, Inc., prior to shipping.
If the product has been in contact with
blood or body fluids, it must be thoroughly
cleaned and disinfected before packing. It
should be shipped in either the original
carton or an equivalent carton, to prevent
damage during shipment; and it should be
properly labeled with an RGA number and
an indication of the biohazardous nature of
the contents of shipment.
Instructions for cleaning and materials,
including appropriate shipping containers,
proper labeling, and an RGA number may
be obtained from AtriCure®, Inc.
CAUTION: It is the responsibility of the
health care institution to adequately prepare
and identify the product for shipment.
DISCLAIMER STATEMENTS
Users must assume responsibility for
approving the condition of this product
before it is used. AtriCure®, Inc., cannot be
held liable for any consequential damage,
personal injury or damage to property nor
for the misuse of this product.
AtriCure, Inc., will not be liable for any
damage caused by the reuse of this
product.
This Instruction for Use describes the
procedures for proper use of the product.
Any deviation from these procedures, which
may compromise the function of the
product, is the responsibility of the user.

P000154.L
Explanation of symbols on package
labeling
Refer to the outer package label to see
which symbols apply to this product.
Non-Pyrogenic
Sterilized by Ethylene Oxide
Single Use Only
Expiration Date
Lot Number
Caution: Federal Law (USA)
restricts this device to sale by or on
the order of a physician
Attention. See Instructions for Use
Latex Free
Follow Instructions for Use
CE Mark with Notified Body - class
II and III medical devices comply
with EC Directive 93/42/EEC
Manufactured by:
AtriCure Incorporated
7555 Innovation Way
Mason, Ohio 45040 USA
Customer Service:
1-866-349-2342 (toll free)
1-513-755-4100 (phone)