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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•Do not activate the CoreCath 2.7S while in contact with metal objects and instruments as unintended
tissue injury may occur.
– Special care should be taken in patients with metal implants such as stents.
– The presence of a growing tumor may decrease visibility of a stent.
– Do not touch a stent with the active cutting tip/electrode of the CoreCath 2.7S.
•The CoreCath 2.7S should only be used with a qualied Generator on output settings with peak voltages
equal to or less than the rated accessory voltage.
•Not intended to be used as a lung aspirator.
Precautions:
•Bronchoscopic procedures should only be performed by persons having adequate training and familiarity
with bronchoscopic techniques.
•A thorough understanding of the technical principles of electrosurgery, as well as clinical applications and
associated risks, is necessary before using this device.
•The cable on the device should be positioned in a way to avoid contact with the patient or other cables.
•Consult the operating and user manuals for light sources, other electrosurgical units, and other ancillary
devices for operating instructions, warnings, and cautions prior to their use in the same surgical eld as
Medtronic’s device.
•It is recommended that physicians utilize pre-clinical training, review of pertinent literature and
other appropriate educational tools before attempting newer surgical procedures, such as endoscopic,
laparoscopic, or thoracoscopic procedures.
•Examine the shipping carton, packaging, sterile barrier, and device for any signs of transit damage. If
there are any shortages, breakage, or apparent damage, do not use the device. Return the device to
Medtronic Navigation, Inc. and use a new device.
•The patient should not be allowed to come in contact with grounded metal objects.
•Never use this device with a bronchoscope that is incompatible with high-frequency current. Using an
incompatible bronchoscope may compromise patient or user safety.
•When High Frequency (HF) surgical equipment and physiological monitoring equipment are used
simultaneously on the same patient, any monitoring electrodes should be placed as far as possible from
the surgical site.
•In all cases where monitoring electrodes are used, the use of monitoring systems incorporating high
frequency current limiting devices are recommended.
•Patient leads should be positioned in such a way that contact with the patient or other device electrical
leads is avoided. Temporarily unused Endoscopic Cutter should be stored in a location that is isolated
from the patient.
•Neuromuscular stimulation can occur with modes which produce electrical arcs between the active
electrode and tissue.
•Do not wrap the cable around metal objects. Wrapping the cable around metal objects may induce currents
that could lead to shock, res, or injury to the patient or surgical personnel.
•Unless the product is being used to spot coagulate a vessel, it is recommended to keep the electrode tip in
motion while activated to avoid excessive eschar buildup. Excessive eschar buildup can compromise device
performance, including reduced or clogged suction.
•Use the device with caution in the presence of pacemakers, as electrosurgical devices may cause
interferenc e with pacemakers or other active implants due to concentration or re-direction of HF currents.
•Place any monitoring electrodes being used as far away as possible from the device to avoid electrical
interference with monitoring equipment.
– Avoid needle-monitoring electrodes.
– Use monitoring systems incorporating high frequency current limiting devices.
•Use this device only with a qualied Pump Generator. Read the warnings, precautions, and instructions
provided with the selected, qualied Pump Generator user guide before use. Specic instructions for the
generator are not included in this IFU.
•High power settings may result in deeper tissue eect than lower power settings.
•The depth of eect is deeper and increases with time if the electrodes are held stationary, with less
depth of eec t if the electrodes are moved over tissue.
•The zone (depth and width) of thermal damage may increase with repeated activation at the same site.
•Skin to Skin contact (for example between the arms and body of the patient) should be avoided, for
example by insertion of dry gauze.
•Before using the device, conrm the following:
– The cable from the device is connected to the selected Pump Generator.
– All electrical connections are tight, clean, and dry.
– All suction connections are secure.
– The generator is set at the desired power level.
Setting Up the CoreCath 2.7S Device
STEP 1: Inspect Device
•Prior to initial use, ensure that all package inserts including warnings, cautions, and Instructions for Use
are read and understood.
•Inspect the CoreCath 2.7S device, power cable, suction tubing, and packaging for signs of damage or
sterile barrier breach; DO NOT use damaged or defective product.
•Check expiration date. Discard product if it has exceeded the expiration date. Call customer service to
report (+1 800 595 9709).
Precaution:
• The Medtronic CoreCath 2.7S device is provided sterile and is to be disposed after a single use. Sterility is
NOT guaranteed if the package is opened or damaged or if the device is used after its expiration date. Do
not re-sterilize.
STEP 2: Set Up Device System
1. Ensure that a compatible flexible bronchoscope with minimum 2.8 mm diameter working channel and
maximum active length of 600 mm is available.
2. Attach the biopsy valve supplied with your bronchoscope to the working channel.
3. Plug the qualified Medtronic electrosurgical generator into a power outlet.
4. Connect the qualified wireless switch per the AEX-Pulsar Footswitch System Operator’s Manual. Inspect
the footswitch and receiver before use. DO NOT use if damaged.
5. Refer to the generator Instruction Manual for selection and placement of appropriate patient return
electrode.
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STEP 3: Prepare Device for Use
1. Using the aseptic technique, remove the sterile tray containing the CoreCath 2.7S from the outer carton
and peel back the Tyvek lid exposing the contents inside.
2. Remove the device from the packaging by gently placing it on the sterile field to avoid compromising
quality or sterility of the device. Remove the protective tip cover.
3. With the generator powered OFF, connect device power cable to the qualified electrosurgical generator.
Ensure that the plug is fully inserted into the generator receptacle. Take caution during device set up to
avoid tripping on device power cable.
4. Plug device suction connector into a compatible OR suction unit. Ensure a firm connection. Consider
starting at a lower suction power and adjusting as needed.
5. Power on the qualified generator in preparation for device use.
6. Care should be taken during insertion of CoreCath 2.7S into bronchoscope to prevent damage to device
tip electrode.
7. Carefully insert the small metal cutting tip of the CoreCath 2.7S through the biopsy valve and into the
2.8 mm working channel of the bronchoscope. Gradually advance the catheter until the blue band at the
distal end of the device appears on the visual monitor. When the blue band appears through the distal
end of the scope, the device is now ready for activation. If catheter does not advance easily, rotate device
back and forth slightly while advancing.
Electrode
Blue band
Warning:
• Skin-to-skin contact (for example between the arms and body of the patient) should be avoided, for
example by insertion of dry gauze.
Precaution:
• Alternate means for hemostasis should be available if bleeding continues.
Activating the CoreCath 2.7S Device
1. Apply the electrode tip to the treatment tissue.
2. Activate the device by pressing the CUT or COAG pedals on qualified footswitch. Adjust settings as needed
for desired tissue effect.
3. Hold the device electrode on the treatment tissue for 2-4 seconds to achieve optimal tissue effect. Do
not activate the device continuously to avoid over-treatment of tissue. If power is insufficient, adjust by
increasing power on the generator until optimal settings are achieved.
Warning:
• Failure of the High Frequency (HF) surgical equipment could result in an unintended increase of output power.
Precaution:
• Do not force the CoreCath 2.7S through the working channel of the exible bronchoscope as this may cause
the device tip and/or the inner walls of the bronchoscope to become damaged. If resistance is encountered
during insertion, withdraw bronchoscope from the patient in order to straighten it.
Adjusting the RF Power Setting
Set the RF power using the POWER SETTING buttons located on the front panel of the Generator.
– Press the button to increase the RF power.
– Press the button to decrease the RF power.
The RF power changes in increments of 5 watts in the range of 0 to 40 watts on CUT, and in increments of
5 watts in t he range of 0 to 20 watts on COAG. If either button is held down the setting will change slowly,
then more rapidly. Release the button when the desired RF power setting is displayed. If either mode is set
to 0 watts, that mode will be deactivated and output no power. The RF power setting cannot be adjusted
while the device is being activated.
Mode
CUT
LOW COA G
Level
(LCD display)
10 10 @ 500
15 15 @ 500
20 20 @ 500
25 25 @ 500
30 30 @ 500
35 35 @ 500
40
10 10 @ 500
15 15 @ 500
20 20 @ 500
[W-RMS] @ Load (Ohms)
0 0 (Output disabled)
5 5 @ 500
0 0 (Output disabled)
5 5 @ 500
Power
40 @ 500
Maximum Output
Voltage
(Vpk)
585
1500
Warning:
• 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. Do not use the device on settings exceeding
the rated accessory voltage.
3
Adjusting the Smoke Evacuation
•The device will evacuate smoke from the eld of view. Suction level is controlled by the OR suction unit,
but can be turned on and o from the device. To shut o suction from the device, press down on the blue
clamp on the suction cable until the clip locks into place. To reactivate suction, unclamp the suction line. In
event of undesired suction outcomes, ensure a secure connection of device to OR suction unit or that the
device suction clamp is in the open position.
•In event of a clog in the suction tubing, deactivate the device suction by closing the blue clamp as directed
above and resort to other methods of smoke evacuation.
Cleaning the CoreCath 2.7S Device
1. Carefully advance and withdraw the CoreCath 2.7S device under visual guidance to avoid possible injury
to the patient or surgical personnel and/or damage to the devices.
2. To avoid having excess tissue char buildup on the CoreCath 2.7S electrode, the device may be removed
for cleaning. Carefully pull the catheter to remove from the bronchoscope and biopsy valve then gently
clean with a damp cloth or damp gauze, taking caution not to deform the device tip. DO NOT use sharp
objects to clean electrode as it could damage the device and compromise performance.
3. Visually inspect the electrode tip after cleaning and before uses to assess device integrity.
4. Place the electrosurgical device in a clean, dry, non-conductive and highly visible area away from the
patient when not in use.
Precaution:
• If ever the CoreCath 2.7S cannot easily be withdrawn from the bronchoscope, unplug the cable, carefully
withdraw the entire bronchoscope from the patient then cut the tip o the device with a pair of scissors
outside the sterile eld.
• Using dry gauze to clean the tip is NOT recommended as gauze bers may get caught in the tip. Avoid
using a scratch pad or other abrasive mechanism to remove coagulum buildup, as it may cause damage
to the coated tip.
• Take caution when cleaning the tip as it may temporarily remain hot enough to cause burns after the
electrosurgical current is deactivated.
• Avoid the footswitch while cleaning the tip so as NOT to activate device while cleaning.
Disposing of the CoreCath 2.7S Device
1. Unplug the device power cable from the electrosurgical generator and carefully remove the CoreCath
2.7S from the bronchoscope. Do not pull on the power cable. Pulling the cable may cause damage to the
electrosurgical generator.
2. See “Cleaning the CoreCath 2.7S” section above for instructions on removing the device from the
bronchoscope.
3. Dispose all components of the single-use device according to hospital regulations for biohazardous
material.
Technical Description
General Information:
Sterile, EO Single-Use, Do Not Reuse, Non-pyrogenic.
Caution: Do Not Use Beyond Expiration Date.
Caution: Federal Law (USA) restricts this device to sale, distribution, and use by or on the order of a
physician.
Caution: Read Instructions For Use (IFU) before using this device.
See text of these Instructions For Use for additional Warnings and Precautions.
Physical Description:
Outer Diameter (catheter): <2.7mm (0.106 inches)
Working Length (without cables): 100 cm ± 5 cm (39.37 inches)
Length of Electrical Cable: approximately 10 feet (3 meters)
Weight (with cables): 110 grams / 3.885 ounces
Operating Conditions:
Temperature: 50 °F to 86 °F (10 °C to 30 °C)
Humidity: 15% – 85%, non-condensing
Storage Conditions:
Temperature: 50 °F to 90°F (10 °C to 32 °C)
Humidity: 0% – 85%, non-condensing
Handling Conditions:
Temperature: -20 °F to 122 °F (-29 °C to 50 °C)
Humidity: 0% – 85%, non-condensing
Disposal:
Dispose of used devices as a biohazard.
Customer Service
Please call Medtronic Customer Service at +1 800 595 9709 if you have any device returns or questions
about Medtronic’s device.
Limited Express Warranty
IF, PRIOR TO THE PRODUCT EXPIRATION DATE, THE STERILIZED DEVICE IS FOUND TO BE INOPERABLE
DURING NORMAL AND PROPER USE IN ACCORDANCE WITH APPLICABLE INSTRUCTIONS, MEDTRONIC
NAVIGATION, INC. WILL REPLACE THE PRODUCT AT NO CHARGE.
This Limited Express Warranty does not extend to a product where the user has compromised the sterile
integrity of the package or the product is used after the product expiration date. A sterile package that
has been compromised should not be used.
4HR4
Disclaimer of Implied Warranties and Consequential Damages
MEDTRONIC NAVIGATION, INC. MAKES NO OTHER WARRANTIES WITH RESPECT TO THE
PRODUCT AND EXPRESSLY DISCLAIMS ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, AS
TO MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE OR ANY OTHER MATTER. IN NO
EVENT SHALL MEDTRONIC NAVIGATION, INC. BE LIABLE FOR ANY INDIRECT, CONSEQUENTIAL
OR SPECIAL DAMAGES OF ANY KIND. THE REMEDIES SET FORTH IN THE LIMITED EXPRESS
WARRANTY ARE THE EXCLUSIVE REMEDIES AVAILABLE TO CUSTOMER.
Symbols
Follow Instructions for Use
Use by Date
Do Not Reuse
Do Not Resterilize
Humidity Limitation
Contains DEHP (di-2-ethyl hexyl phthalate)
Temperature Limitation
Sterilized by Ethylene Oxide
Catalog Number
Lot Number
Manufacturer
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
5
Medtronic Navigation, Inc.
826 Coal Creek Circle
Louisville, CO 80027 USA
+1 800 595 9709
medtronic.com
manuals.medtronic.com
© Copyright 2019
Medtronic Navigation, Inc.
70-10-1542 Rev A
2019/11
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