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Read auxiliary device manual and observe instructions and warnings. This device can be used with a
temporary pacemaker.
Do not connect the pacing/recording adapter 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.
Avoid the possibility of unintentional contact between the device tip electrodes or pacing lead connectors
and any conductive surface contact. The pacing lead connectors should only be connected to a
temporary pacemaker or to a recorder designed for safely recording biopotentials.
Precautions
Contents supplied
STERILE
using an ethylene oxide (EtO) process. Carefully inspect the package prior to
use for any breach of the sterile barrier or damage to the contents. If the sterile barrier integrity is
compromised or the contents damaged, DO NOT USE and contact your ESTECH representative. Use of
product with a compromised sterile barrier may lead to patient injury.
For single use only. Do not reuse, reprocess or re-sterilize. Reuse, reprocessing or re-sterilization may
compromise the structural integrity of the device and/or lead to device failure. Reuse, reprocessing or re-
sterilization may also create a risk of contamination of the device and/or cause patient infection or cross-
infection, including, but not limited to, the transmission of infectious disease(s) from one patient to
another, patient injury, illness or death.
Do not attempt to operate the system before thoroughly reading ESU Operator’s Manual and Instructions
for Use.
Care should be taken when manipulating the device. While the distal portion of the Probe is designed to
be flexible to conform to the anatomy of the area to be ablated, excessive or rough shaping of the suction
stabilizer, including bending and axial torque, may damage internal components of the device. When
using surgical instruments, only grasp at the distal or proximal ends, away from the electrodes. Do not
grasp the electrodes or spine of the suction stabilizer with instruments.
If using a TEE probe, care should be taken to withdraw the TEE probe prior to ablation to avoid
compressing the esophagus against the left atrium during ablation.
User should avoid twisting or extreme manipulation of the device to preclude inadvertent injury to
neighboring tissue (the correct orientation of the device should be ensured).
Many variables, including patient anatomy, pathology, and surgical techniques, may influence procedural
outcomes. Patient and procedure selection is a responsibility of the medical professional.
Avoid attaching the device or ablating over the appendages of the heart, and extremely thin, fragile, or
aneurysmal tissue.
Pacemakers and implantable cardioverter/defibrillators can be adversely affected by RF signals and
magnetic fields. Refer to the manufacturer’s Directions for Use.
Dispersive Indifferent Patch (DIP) electrodes used with the ESTECH system should be applied carefully
according to the manufacturer’s directions. Poor or incomplete contact of the DIP electrodes may result in
skin burns. The use of DIP electrodes which meet or exceed ANSI/AAMI HF-18 requirements is
recommended.
The risk of igniting inflammable gases or other materials is inherent in the application of RF power.
Precautions must be taken to restrict flammable materials from the area where tissue ablation is
performed.
Electromagnetic interference (EMI) produced by the ESU during the delivery of RF power may adversely
affect the performance of other equipment.
Bare electrode tips and lead wire connectors constitute a direct path to the heart. Small currents
(approximately 10 μamps) may be sufficient to cause fibrillation. Only trained personnel should handle the
COBRA Fusion and COBRA Fusion Pacing/Recording Adapter Cable and connecting pins.
Directions for Use (Ablation)
1. Inspect the System and all packaging materials carefully. Open the package using aseptic technique.
2. Ensure 2 DIP electrodes are in good contact, according to the manufacturer’s directions.
3. Connect the ESU cable into the black receptacle on the face of the ESU.
4. If required, attach 1-meter (3-foot) line from the vacuum canister to the vacuum regulator connection.
