AtriCure Isolator User manual

AtriCure®Isolator®Surgical Ablation
System
Instructions for Use
(Page 3)
Système d'ablation chirurgicale Isolator® AtriCure®
Mode d’emploi
(Page 15)
AtriCure®Isolator®-Ablationssystem für die Chirurgie
Gebrauchsanweisung
(Seite 27)
Sistema di ablazione chirurgica Isolator®AtriCure®
Istruzioni per l'uso
(pagina 39)
Sistema de Ablação Cirúrgica Isolator®da AtriCure®
Instruções de Uso
(Página 51)
Sistema de ablación quirúrgica AtriCure®Isolator®
Instrucciones de uso
(página 63)
OLL1
OLL2
OSL2
EMR2
EML2

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AtriCure®Isolator®Surgical Ablation System
Instructions for Use
DESCRIPTION
The ATRICURE ISOLATOR Surgical Ablation System is comprised of the Ablation and
Sensing Unit (ASU), an ATRICURE ISOLATOR device, and a footswitch. The ISOLATOR is
a single patient use electrosurgical instrument designed for use only with the ASU. The
ISOLATOR is used for soft tissue ablation. When activated, the ASU delivers
radiofrequency (RF) energy to the linear electrodes on the insulated jaws of the ISOLATOR.
The Operator controls the application of this RF energy by pressing the Footswitch.
All ISOLATOR devices are configured as vascular clamps and feature clamping jaws of
various lengths and curvatures.
There are three families of ISOLATOR clamps available for use with the system.
The ATRICURE ISOLATOR (See Figure 1) Clamps feature an in-line handle with
syringe-type actuation and button release mechanisms. Some ISOLATOR Devices have
an integral attachment tip and related Glidepath™ Tape Instrument Guide (Guide) as
device options (See Figure 1 and Figure 2). The Guide is packaged with ISOLATOR
devices that have the Attachment Tip.
The ISOLATOR Synergy™ (See Figure 1) Clamps feature two pairs of opposing dual
electrodes, an in-line handle with syringe-type actuation and button release mechanisms.
The ISOLATOR Synergy requires the use of the AtriCure Switch Matrix (ASB3, US and
EU, respectively)
There are two families of GLIDEPATH Tape Instrument Guides for use with ATRICURE
ISOLATOR Devices. The GLIDEPATH Tape Instrument Guide is a single patient, surgical
device designed to facilitate the guidance of surgical instruments through soft tissue during
general surgical procedures
The GLIDEPATH Tape Instrument Snap Guide (See Figure 2) is designed to fit devices
that have the integral attachment tip.
The GLIDEPATH Tape Instrument Press Guide (See Figure 2) is designed to fit
instruments without integral attachment tips.
NOTE: Please refer to the ATRICURE ASU and ASB3 Instructions for Use for
information specific to the ASU and ASB3.

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ATRICURE ISOLATOR
ILLUSTRATION AND NOMENCLATURE
(Figure 1)
Isolator Synergy
*Only on devices packaged with GLIDEPATH Tape Instrument Guide
(ATRICURE ISOLATOR INLINE SYRINGE GRIP CLAMPS)
1. Distal Jaw
6. Handle
2. Proximal Jaw
7. Closure Lever
3. Attachment Tip*
8. Release Mechanism
4. Electrode
9. Connector
5. Jaw Heel
10. Connector Alignment Arrow

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GLIDEPATH TAPE INSTRUMENT GUIDE
ILLUSTRATION AND NOMENCLATURE
(Figure 2)
(Guide)
1. Lateral Tab
2. Distal Pocket
3. Instrument Attachment Tip
4. Red Elastic Leader
5. Clear Ribbon
6. Accessory Ribbon

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INDICATION FOR USE
The ATRICURE Bipolar (Transpolar)
System is intended to ablate soft tissue
during General surgical procedures.
CONTRAINDICATIONS
The Bipolar (Transpolar) System is not
indicated for contraceptive coagulation
of the fallopian tubes.
Potential Complications
Device
Possible complications related to the
creation of the linear lesions in cardiac
tissue using a clamp-type device maybe
be included but not limited to:
•Tissue Cutting
•Perioperative heart rhythm
disturbance (atrial and/or
ventricular)
•Postoperative embolic
complications
•Pericardial effusion or
tamponade
•Injury to the great vessels
•Valve leaflet damage
•Conduction disturbances
(SA/AV node)
•Acute ischemic myocardial
event
•Injury to unintended
surrounding tissue structures,
including tears and punctures.
•Bleeding requiring intervention
to repair.
•Extension of cardiopulmonary
bypass
Procedure
Serious adverse events that may be
associated with surgical ablation
procedures on the heart (stand alone or
concomitant to other cardiac surgery),
include:
•Death
•Excessive bleeding related to the
procedure (defined as bleeding
which requires >3 units of blood
products and/or surgical
intervention),
•Cardiac tamponade (if either open or
catheter drainage is required),
•Pulmonary vein stenosis,
•Restrictive (constrictive) pericarditis,
•Endocarditis,
•Myocardial infarction (MI) per ACC
guidelines,
•Stroke (resulting in permanent
neurological deficit),
•Transient Ischemic Attack (TIA),
•Thromboembolism
•Diaphragmatic paralysis,
•Esophageal-LA fistula or
esophageal rupture,
•Atrial perforation or rupture,
•Ventricular perforation or rupture,
•Atelectasis,
•Pneumonia,
•Congestive Heart Failure,
•Cardiac Valve Injury,
•Persistent Pneumothorax (requiring
intervention),
•Excessive Pain and Discomfort,
•Deep Sternal Wound Infection,
•Ventricular Arrhythmia (V.
Tachycardia or V. Fibrillation)
•New Sinus Node Dysfunction, and
•Drug Reaction
WARNINGS
•Do not touch the electrodes of the
ISOLATOR while activating the
ASU. Touching the ISOLATOR
electrodes during ASU activation
could result in an electrical shock or
burn to the operator.
•Do not touch the electrodes of the
ISOLATOR to metal staples or
clips, or to sutures while activating
the ASU. This may damage the
ISOLATOR or tissue, or result in an
incomplete ablation.
•Do not use abrasive cleaners or
electrosurgical tip cleaners to clean
debris from the Jaws. Use of
abrasive cleaners or electrosurgical
tip cleaners can damage the
electrodes and result in device
failure. Use saline-soaked gauze to
clean debris off the electrodes.
•Do not immerse any part of the
ISOLATOR in liquids as this may
damage the device.

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•Always wear the appropriate
surgical gloves when using the
ATRICURE ISOLATORSurgical
Ablation System to avoid
shock/burn hazards.
•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 ISOLATOR to avoid the
risk of patient infection.
•Electrosurgery should be used with
caution in the presence of internal
or external pacemakers.
Interference produced with the use
of electrosurgical devices can
cause devices such as a
pacemaker to enter an
asynchronous mode or can block
the pacemaker entirely. Consult
the pacemaker manufacturer or
hospital Cardiology department for
further information when use of
electrosurgical appliances is
planned in patients with cardiac
pacemakers.
PRECAUTIONS
•Read all instructions carefully for
the ATRICURE ISOLATOR
Surgical Ablation System, prior to
using the device. Failure to properly
follow instructions may lead to
electrical or thermal injury and may
result in improper functioning of the
device.
•Use of the ISOLATOR should be
limited to properly trained and
qualified medical personnel.
•Use ISOLATOR only for soft tissue
ablation. Variations in specific
procedures may occur due to
individual physician techniques and
patient anatomy.
•Do not drop or toss the ISOLATOR
as this may damage the device.
If the ISOLATOR is dropped, do not
use. Replace with a new
ISOLATOR.
•Do not use the ISOLATOR in the
presence of flammable materials.
•Do not re-sterilize or reuse the
ISOLATOR. Reuse can cause
patient injury and/or the
communication of infectious
disease(s) from one patient to
another.
•Keep the Jaws of the ISOLATOR
clean of debris during surgery to
avoid loss of power.
•Do not use of the ISOLATOR with
another manufacturer’s generator
to avoid damage to the device,
which may result in patient injury.
The ISOLATOR is only compatible
with the ATRICURE ASU and
ASB3.
•Do not ablate tissue greater than
10 mm thick with the ISOLATOR.
Tissues greater than 10 mm thick
may not be fully ablated.
•Do not use the ISOLATOR for
coagulation or ablation of veins or
arteries.
•Inspect the area between the Jaws
of the ISOLATOR for foreign matter
before activating the ASU or ASB3.
Foreign matter captured between
the Jaws will adversely affect the
ablation.

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•Do not insert excessive tissue into
the Jaw heel as it may result in
poor ablation at the Jaw Heel.
•Do not ablate in pool of blood or
other fluids as this may extend the
ablation time. Users should suction
excess fluids away from the jaws
prior to ablation.
•Do not attempt to use an
ISOLATOR that has reached its
time limit expiration. The
ISOLATOR has an 8-hour useful
life that is tracked by the ASU. The
ISOLATOR will no longer function
after 8 hours of use and the ASU
will display a message indicating
that the ISOLATOR must be
replaced.
•Do not use the ISOLATOR if signs
of damaged wire insulation are
noted upon inspection of the area
around the Jaw heel as it may
adversely affect ablation
performance.
•When the ASU (RF generator) and
Handpiece are used on a patient
simultaneously with physiological
monitoring equipment, ensure that
the monitoring electrodes are placed
as far as possible from the surgical
electrodes. Besure to position the
Handpiece cables so that they do not
come in contact with the patient or
the other leads.
•Needle monitoring electrodes are
not recommended for use when
operating the ASU (RF generator)
and Handpiece.
•Monitoring systems that incorporate
high frequency current-limiting
devices are recommended for use
with the ASU (RF generator) and
Handpiece.
•When the ASU (RF generator) is
activated in conjunction with the
Handpiece, the conducted and
radiated electrical fields may
interfere with other electrical
medical equipment. Refer to the
ASU IFU for more information
regarding potential electromagnetic
or other interference, and advice
regarding avoidance of such
interference.

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INSTRUCTIONS FOR USE
SET UP
1. Examine the packaging of the devices
to ensure the sterility of the product
has not been breached. Remove the
sterilized instruments from their
package per standard sterile
technique.
2. With the Connector Alignment Arrow
symbol in the 12 o’clock position, push
the Connector into the appropriate
ISOLATOR receptacle on the front of
the ASU or ASB3. Each ISOLATOR
has a unique receptacle on the ASB3.
To ensure device performance, verify
proper connections to the ASB3 by
consulting the ASB3 package insert.
Verify that the connections between
the ISOLATOR and the ASU or ASB3
are secure. If the connections are
loose, do not use the ISOLATOR.
Inspect the Cable and do not use the
ISOLATOR if the cable is frayed or the
insulation is damaged.
3. If the ISOLATOR is to be used with a
supplied GLIDEPATH Instrument
Guide (Integrated Guide –Figure 2),
go to step 4.
If the ISOLATOR is not to be used with
the instrument guide, go to step 20.
POSITIONING OF GLIDEPATH TAPE
GUIDE
4. The Guide may be used with
commercially available general
dissection or surgical clamping tools
(auxiliary tools) to create and maintain
a dissection plane that facilitates
placement of the ISOLATOR clamp
around structures per standard
surgical technique.
5. Examine the Guide package to ensure
the sterility of the product has not
been breached. Remove the Guide
from its packaging per standard sterile
technique.
6. Secure the proximal end of the Guide
to the sterile drape near the surgical
site.
7. Insert the distal end of the auxiliary
tool completely into the distal pocket of
the clear ribbon portion of the Guide.
8. Maintain attachment of the distal
portion of the Guide to the auxiliary
tool during positioning of the Guide.
Note: Lubrication may be applied to
the Guide at the user’s discretion.
9. Once the desired placement of the
Guide is achieved, use a grasping
device to grasp one of the Lateral
Tabs (Figure 2) on the Guide and
remove the Guide from the auxiliary
tool. Externally secure the distal end
of the Guide near the surgical site.
Note: If an articulating dissection tool
is used, un-articulating the device may
facilitate removal of the Guide.
Insert with Connector Alignment
Arrow at the 12 o’clock position

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10. If desired, the Guide can be used for
soft tissue retraction or to introduce
additional Instruments through the
previously created positioning plane.
11. If the Guide incorporates a snap
feature, refer to steps 13-14 for
instrument exchange.
12. If the Guide incorporates a press
feature, refer to steps 15-19 for
instrument exchange.
INSTRUMENT EXCHANGE (SNAP
GUIDE)
13. Prior to attaching the Guide to the
ISOLATOR, unclamp the proximal end
of the leader from the sterile drape.
14. While holding the Guide as shown, in
the illustration below, insert the
Instrument Attachment Pin (Figure 2)
into the ISOLATOR attachment tip
(Figure 1). Once Guide is attached, do
not attempt to remove by forcibly
pulling on Guide.
INSTRUMENT EXCHANGE (PRESS
GUIDE)
15. If using an AtriCure Instrument Press
Guide, attach the guide to the distal tip
of the ISOLATOR per standard
surgical technique.
16. Use the guide to facilitate the
placement of the ISOLATOR in the
previously created positioning plane.
17. Carefully remove the guide from the
distal jaw after ISOLATOR placement.
NOTE: The Press Guide is to be
removed prior to ablation. (Refer to
Step 28)
NOTE: The accessory ribbon allows
the surgeon to create a dissection
plane in one direction (inferior or
superior) and maneuver the tape and
leader through the dissection plane so
that an instrument (clamp) can be
used from the opposite direction.
18. If it is required to reverse the direction
of device placement, the accessory
ribbon is attached to the distal pocket
of the primary transfer tape.
19. After creation of the dissection plane,
pull the distal end of the primary tape
while providing counter traction on the
proximal end of the accessory ribbon
so that the leader is pulled through the
dissection plane.
ABLATION
NOTE: A minimum tissue incision of
12 mm is recommended for insertion
of the ISOLATOR.
20. Place the targeted tissue between the
Distal and Proximal Jaws.
21. Squeeze the Closure Lever to close
the Jaws. Ensure that no target tissue
extends beyond the Indicator Line on
either the Distal or Proximal Jaws or
into the Jaw Heel.
22. Activate the ASU by depressing the
footswitch.
When the ASU is activated, the ASU
will emit an audible tone indicating that
current is flowing between the Jaws of
the ISOLATOR.
When the continuous tone switches to
intermittent, release the footswitch.