Emprint Ablation Reusable Cable Instructions for Use

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Emprint™

Indications for Use

CA190RC1 Ablation Reusable Cable 190 cm

Not made with natural rubber latex

Do not use if package is opened or damaged

Emprint™ Ablation System with Thermosphere™ Technology The Emprint™ Ablation System with Thermosphere™ Technology is intended for use in percutaneous, laparoscopic, and intraoperative coagulation (ablation) of soft tissue, such as lung, kidney and liver, including partial or complete ablation of non-resectable liver tumors. The Emprint™ Ablation System with Thermosphere™ Technology is not intended for use in cardiac procedures. Consult the Emprint™ Ablation System User’s Guide for target patient population, user group, and clinical benefit statement of the system.

Emprint™ SX Ablation Platform with Thermosphere™ Technology Type BF applied part

Cable connect/disconnect

The Emprint™ SX Ablation Platform with Thermosphere™ Technology is intended for use in percutaneous, laparoscopic, and intraoperative coagulation (ablation) of soft tissue, including partial or complete ablation of non-resectable liver tumors. The Emprint™ SX ablation platform is not intended for use in cardiac procedures. The system’s optional, 3-D navigation feature assists in the placement of the Emprint™ SX Navigation Antenna with Thermosphere™ Technology using real-time image guidance during intraoperative and laparoscopic ablation procedures. The navigation feature enhances the output of the compatible medical ultrasound imaging system and displays an image of the antenna and its predicated trajectory on a computer monitor. The size and shape of the predicated ablation zone relative to the position of the antenna is displayed on the enhanced ultrasound image. Warning

For use with the following equipment: • Emprint™ Ablation System with Thermosphere™ Technology • Emprint™ SX Ablation Platform with Thermosphere™ Technology The Emprint™ Ablation Reusable Cable is a highefficiency, flexible cord used to connect an Emprint™ percutaneous antenna or an Emprint™ SX navigation antenna to an Emprint™ ablation generator, Emprint™ HP ablation generator, or Emprint™ SX ablation platform. The reusable cable comprises a cable assembly that has two connecting ends. The generator side can be identified by the black connector core and the connector with a soft, white silicone boot. The treatment side can be identified by the white connector core and the hand-piece housing that accepts the antenna. The connector graphics on the treatment side are blue and the connector graphics on the generator side are black (or black and white). The connectors are also keyed to physically prevent reversing the connector arrangement, ensuring correct configuration.

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The suggested replacement period of the reusable cable is following one thousand connections/disconnections with the Emprint™ ablation generator, the Emprint™ HP ablation generator, or the Emprint™ SX ablation platform, one thousand connections/disconnections with Emprint™ percutaneous antennas or Emprint™ SX navigation antennas, or following one year of use, whichever occurs first. Use beyond this period may result in patient injury, operator injury, or poor performance. Do not use the reusable cable with any device other than the Emprint™ ablation generator, the Emprint™ HP ablation generator, or the Emprint™ SX ablation platform. Use with other devices may result in patient injury, operator injury, or poor performance. Do not use the reusable cable with any antenna other an Emprint™ percutaneous antenna or an Emprint™ SX navigation antenna. Use with any other antenna may result in patient injury, operator injury, or poor performance. Do not over-bend or attempt to kink the reusable cable as this may lead to damage to the reusable cable which could adversely alter the overall performance of the reusable cable.

en Warning Do not attempt to connect or disconnect the reusable cable to or from the generator or antenna while microwave power is active. This could lead to burns or other injuries to the user and damage to the reusable cable, antenna, or generator.

Instructions for Use with the Emprint™ HP Ablation Generator with Thermosphere™ Technology

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No modification of this equipment is allowed under any circumstances.

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Caution Consult the Emprint™ Ablation System with Thermosphere™ Technology User’s Guide or the Emprint™ SX Ablation Platform with Thermosphere™ Technology User’s Guide for detailed installation instructions, important safety information, and indications for use for the selected ablation system. Ensure that all connections are locked to ensure proper delivery of microwave energy. Store in a cool, dry place.

Instructions for Use with the Emprint™ Ablation Generator with Thermosphere™ Technology

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1 Generator connector port 2 Align arrows during connection 3 Generator connector

Instructions for Use with the Emprint™ SX Ablation Platform with Thermosphere™ Technology Emprint SX

Emprint W

°C

MM:SS MM

RTP LIMIT

RESET

START/ STOP

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SS

?

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1 Generator connector port 2 Align arrows during connection 1 Generator connector port 2 Align arrows during connection 3 Generator connector

3 Generator connector

Cable Release Grip The connectors used on the cable all have similar function. The connectors feature an auto-latching mating action that provides audible, visible, and tactile confirmation that the connections are fully engaged. When connecting the reusable cable, hold the reusable cable behind the coupling collar, align the arrows on the reusable cable to the receptacle arrow and gently push towards the receptacle until you hear a click confirmation. The arrow graphics should now be aligned to indicate a locked mating of the connectors. Only the rotating collars of the reusable cable should be held when disconnecting the antenna or when disconnecting the cable from the generator. When disconnecting, gently rotate the collars 1/8 of a turn in the direction of the arrow graphic. Avoid any bending. Never pull the cable prior to disconnecting the coupling collar. 3

en Warning Do not bend, kink, or otherwise stress the reusable cable. Irreparable damage may occur.

Cable Specifications Length x Diameter

190 cm x 3.4 cm

Weight

500 g

Power Handling

100 watts

Material

Silicone/TEKBOND TB1723/ GRILAMID LV-3H

Connector Type

Custom with integrated microwave and data communication

1. The following chemical agents have been tested and are deemed compatible for system wiping down. • Cavicide • 75% Ethyl alcohol • 75% Isopropanol • 6% Sodium Hypochlorite (bleach) • 10% Hydrogen Peroxide 2. Apply the desired chemical agent to a lint-free cloth. 3. Wipe the cable. Warning Ensure that equipment is disconnected from mains prior to wiping down. Warning

Sealing

IP20

Ensure connectors are dry prior to use. Always use protective eyewear when using compressed air.

Temperature Range

Operating: 10°C to 30°C (50°F to 86°F) Transport and storage: -30°C to 60°C (-22°F to 140°F)

Symbols

Relative Humidity

Operating: 15% to 90% (non-condensing) Transport and storage: 15% to 90% (non-condensing)

Atmospheric Pressure

Operating: 66 kPA to 106 kPA Transport and storage: 50 kPA to 106 kPA

Non-Sterile

Not made with natural rubber latex

Do not use if package is opened or damaged

Caution The ablation reusable cable needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in the Emprint™ Ablation System with Thermosphere™ Technology User’s Guide or the Emprint™ SX Ablation Platform with Thermosphere™ Technology User’s Guide.

Consult instructions for use

Caution, consult accompanying documents

The ablation reusable cable intentionally applies MW energy for diagnosis or treatment during activation. Observe other electronic medical equipment in the vicinity during cable activation for any possible adverse electromagnetic effects. Ensure adequate separation of electronic medical equipment based on observed reactions.

Wiping Down the Cable

If the cable needs to be wiped down, use the following procedure. NOTE: Do not spray or pour chemicals or other liquids onto the cable. The cable cannot be sterilized. Do not allow liquid to enter the cable. Sterilization will destroy the electronic components within the cable.

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Medical device °F °C °F °C Temperature limitations

Temperature limitations

Keep dry

en Waste from electrical and electronic equipment

Type BF applied part

GOST

CE mark

Manufacturer

Serial number

Date of manufacture

Cable connect/disconnect

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Part No. PT00121278 COVIDIEN, COVIDIEN with logo, and Covidien logo and Positive Results for Life are U.S. and internationally registered trademarks of Covidien AG. ™* brands are trademarks of their respective owners. Other brands are trademarks of a Covidien company. May be covered by U.S. Patents: www.covidien.com/patents © 2013, 2020 Covidien. All rights reserved. Made in UK. Printed in USA. REV 2020-08 Manufactured for Covidien llc, 15 Hampshire Street Mansfield, MA 02048 USA. www.covidien.com Medtronic B.V., Earl Bakkenstraat 10, 6422 PJ Heerlen, The Netherlands.