CoreCath™ 2.7S
Single-Use Device Designed for Use
with Qualied Pump Generators
26-103-1
EN Instructions For Use
FR Mode d’emploi EL Οδηγίες χρήσης
IT Istruzioni per l’uso PL Instrukcja obsługi
DE Anweisungen für die Verwendung CS Návod kpoužití
ES Instrucciones de uso HU Használati utasítás
NL Gebruiksinstructies TR Kullanma Talimatları
DA Brugsanvisning NO Bruksanvisning
SV B ruksanvisning RU Инс трукция по эксплуатации
FI Käyttöohjeet SR Uputstvo za upotrebu
PT-PT Instruções de Utilização HR Upute za upotrebu
PT-BR Instruções de uso
EN © 2019 Medtronic. All rights reserved. Medtronic, Medtronic logo and Further, Together
are trademarks of Medtronic. All other brands are trademarks of a Medtronic company.
User Information
Read all information in this package insert carefully. Failure to properly follow instructions may lead to
electrical or thermal injury and result in improper functioning of the device. Also read all instructions for
use of the electrosurgical generator and the instructions for use of the bronchoscope as well.
Indications for Use
The CoreCath 2.7S is a single use electrosurgical instrument designed to be used with flexible
bronchoscopes and qualified electrosurgical units. It is indicated for cutting of soft tissue obstructions in
upper airways and tracheobronchial tree, providing electrosurgical hemostasis, and evacuation of surgical
smoke during such procedures.
Device Description
The CoreCath 2.7S is intended to be inserted through the working channel of a flexible bronchoscope having
an instrument channel diameter of 2.8 mm minimum and a working length of 600 mm, activated by a
footswitch connected to a qualified electrosurgical generator, and utilized in electrosurgical procedures
involving removal/cutting of soft tissues (excision, incision, vaporization, ablation) while also providing
electrosurgical coagulation and hemostasis.
Figure 1. Side view of CoreCath 2.7 (Length of cable, shaft and suction lines not to scale)
Suction Tubing
Suction
Monopolar Electrode
Clamp
Connector
Protective
Tip Cover
Catheter
(Not to scale)
Cable Clip
Power Cable
The CoreCath 2.7S is intended to be activated by the footswitch accessory supplied with the electrosurgical
generator. A visual indicator at the distal end of the device informs the user when the CoreCath 2.7S has
passed through the full length of the bronchoscope and is ready for activation.
The CoreCath 2.7S is sized such that it may be delivered through a bronchoscope with a minimum 2.8 mm
diameter working channel and active 600 mm working length.
Contraindications:
1. The CoreCath 2.7S is not appropriate for patients for whom a therapeutic bronchoscopy or RF
electrosurgery procedure is contraindicated for any reason.
2. This system is not intended for patients with any contraindications against electrosurgical procedures.
Warnings
•For patients having cardiac pacemakers or other electrically conductive implants, contact the respective
manufacturer for guidelines. Interference with the function of or damage to cardiac pacemakers or other
active implants may occur.
•A patient return electrode (PRE) is required for use of this device. Ensure that all connections are secure
and monitored closely to maintain appropriate patient contact during use. Consult patient return
electrode manufacturer’s Instructions For Use for proper placement and use. Assure that the area of
the patient return electrode placement has adequate surface area, musculature, and vasculature for
the anticipated current and duration of use. It is important that there be sucient musculature and
vasculature for the current distribution so that there are no current concentrations, such as at the edges.
Refer to manufacturer’s Instructions For Use for all devices used, including the generator, patient return
electrode, and all other associated equipment. It is also important not to have warming pads or blankets
in operation or around the PRE during the time that the device is activated as this could increase the
temperature of the PRE.
•Compatible generator contact quality monitoring (CQM) systems will only function properly with split-style
patient return electrodes. Other patient return electrode products may not identify loss of safe contact
between the return electrode and the patient, thereby failing to provide auditory or visual alarms and
causing patient injury or product damage.
•Care must be exercised when using electrosurgical instruments to minimize the risk of patient injury. Safe
and eective electrosurgery is dependent on factors under the control of the user, as well as equipment
design and its adequate inspection and maintenance.
•During electrosurgical procedures be alert to these potential hazards:
– As with all electrosurgical devices, do not use in cases in which Forced Inspired Oxygen (FiO2)
exceeds 40%.
•An electrosurgical device has the potential for providing a source for ignition. Endogenous gases which
accumulate in body cavities can be subject to ignition.
– The CoreCath 2.7S tip may temporarily remain hot enough to cause burns after the electrosurgical
current is deactivated.
•Proper suction connection is important to prevent a build-up of ammable or oxidizing gases at the
surgical site. During use, monitor the device for inadequate suction performance, which might be
apparent by excessive / visible smoke or burnt odor.
•Do not touch the tip of the CoreCath 2.7S when power is being applied.
•Do not insert (into the bronchoscope) or withdraw the CoreCath 2.7S (from the bronchoscope) while
power is being applied.
•This Medtronic device is labeled as SINGLE USE. Do not reuse or re-sterilize any product labeled as
SINGLE USE.
•Inspect the device and cord for breaks, cracks, nicks, or other damage before use. Failure to observe this
caution may result in injury or electrical shock to the patient or surgical team.
•Interference produced by the operation of the RF surgical equipment may adversely inuence the operation
of other electronic equipment.
•Failure of the RF surgical equipment could result in an unintended increase of output power.
•Use the lowest setting possible to achieve the desired tissue eect to avoid over-treatment which could
result in swelling, uid, seroma or unintended tissue necrosis.
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