DiamondTemp EGM Cable Instructions for Use

The following list includes trademarks or registered trademarks of Epix Therapeutics, a Medtronic company, in the United States and possibly in other countries. All other trademarks are the property of their respective owners: DiamondTemp, Epix

Explanation of symbols Refer to the package and product labels to see which symbols apply to this product and for the product-specific information, such as the date of manufacture. Consult instructions for use Consult instructions for use at this website Do not dispose of this product in the unsorted municipal waste stream. Dispose of this product according to local regulations. See http://recycling.medtronic.com for instructions on proper disposal of this product. Reorder number Lot number Manufacturer Date of manufacture Manufactured in Keep dry Fragile, handle with care Do not use if package is damaged Storage temperature limit Transit temperature limit Temperature limit Humidity limitation Medical device Model number Unique Device Identifier Importer Package contents Product documentation EGM cable Conformité Européenne (European Conformity). This symbol means that the device fully complies with applicable European Union acts. Authorized representative in the European Community

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Compliance mark indicating conformance to applicable standards For Brazil audiences only For Canada audiences only For Australia and New Zealand audiences only

1 Device description The DiamondTemp EGM cable (CEDTEGM100) connects the RF generator to a hospital’s compatible EP recording system. This feature is used with the DiamondTemp ablation catheters. (Note: Any electronic recording or stimulation equipment used with the catheter must be compliant with the applicable standards, such as IEC 60601-1.) The DiamondTemp EGM cable is supplied separately for use with the DiamondTemp RF generator. The EGM cable should be used only with the DiamondTemp ablation system. (The EGM cable can also be used to connect the DiamondTemp Generator Connection Box E to the EnSite™ Amplifier. For more information, see the DiamondTemp Generator Connection Box E Instructions for Use.) Figure 1. DiamondTemp EGM cable

1 Male, 9-pin connector 2 Male, 2.0 mm shrouded pin connectors (x4) 3 D1 pin connector

4 D2 pin connector 5 R1 pin connector 6 R2 pin connector

2 Contents of package The cable is supplied nonsterile. The package contains the following items: • One model CEDTEGM100 EGM cable • Product documentation

3 Indications for use and contraindications Refer to the instructions for use for the compatible DiamondTemp catheter being used for the indications for use and contraindications.

4 Intended purpose The DiamondTemp EGM cable is intended to connect the DiamondTemp RF generator to an external EP recording system.

5 Intended user The intended user of the DiamondTemp ablation system is either a physician trained in cardiac ablation procedures, or a physician who is supervised by a physician trained in cardiac ablation procedures. For information about available training, contact your Epix Therapeutics representative.

6 Intended patient population Refer to the instructions for use of the compatible DiamondTemp catheter being used for the intended patient population.

7 Clinical benefit Refer to the instructions for use of the compatible DiamondTemp catheter being used for the clinical benefit. 4

8 Warnings and precautions Review the system documentation – The EGM cable is part of the DiamondTemp ablation system. Review the DiamondTemp catheter instructions for use and other DiamondTemp system instructions for use for warnings and precautions, adverse events, and instructions. Product compatibility – For use only with the DiamondTemp RF generator. Use with other ablation systems has not been assessed, and may compromise patient or operator safety. Inspect the package – Carefully inspect the package before opening. If the package has been damaged or opened, do not use and contact your Epix Therapeutics representative. Inspect the cable – Inspect the cable thoroughly. Check for insulation damage, such as brittleness, cracking, or bare spots. Do not use the cable if it appears to be damaged. Connection to generator – All devices that are connected to the RF generator must be safe for patients per specifications in IEC 60601-1 and IEC 60601-2-2. Improper use may be dangerous for the patient. Cable integrity – Do not use the cable if it is kinked or damaged. If the cable becomes kinked or damaged while in use, remove it and use a new cable. Leakage current – Use only isolated amplifiers, pacing equipment, and ECG equipment (IEC 60601-1 Type CF equipment or equivalent) or patient injury or death may occur. Leakage current from any connected device to the patient must not exceed 10 micro Amps (µA) under any circumstances. Do not modify – Do not modify this equipment. Modifications may reduce system effectiveness and impact patient health. Cleaning – Do not immerse in any liquid. Do not use an automated cleaning or disinfection process with this component. Sterilization and reuse – The cable is provided nonsterile and is not intended for sterilization. The cable can be reused up to ten (10) times. Reusing the cable more than ten times may lead to device malfunction, resulting in failure to complete the procedure or possibly patient injury. Disposal – Do not dispose of this product in the unsorted municipal waste stream. Dispose of this product according to local regulations. Serious incident – If a serious incident related to the device occurs, immediately report the incident to Epix Therapeutics and the applicable competent authority or regulatory body. Technical manual information – If you find information in this manual that is incorrect or illegible, contact your Epix Therapeutics representative or your local competent medical authority.

9 Adverse events For potential adverse events, see the instructions for use for the compatible DiamondTemp catheter being used.

10 Directions for use Note: Inspect the cable before use. Do not use this cable if it appears to be damaged. To connect the EGM cable, use the following steps: 1. Insert the connector on the cable into the EGM output (ECG/Pace) on the DiamondTemp RF generator. 2. Connect the four 2 mm shrouded pins on the end of the cable to the EP recording system (D1, D2, R1, R2 as shown in Figure 1). The D1 pin corresponds to the most distal tip electrode of the catheter. To disconnect the cable, pull back on the locking ring to release the cable and then detach the cable from the generator. For additional information on using the cable with the RF generator, see the DiamondTemp RF Generator User Manual. (The cable can also be used to connect the DiamondTemp Generator Connection Box E to the EnSite™ Amplifier. See the DiamondTemp Generator Connection Box E Instructions for Use.)

11 Cleaning and disposal After use, the cable may be reused (up to 10 times) or disposed per standard procedures for electrical cables and in accordance with local laws and regulations. The cable is not required to be cleaned before use, but it may be cleaned between uses. To clean the cable, use the following steps: 1. Clean the cable by wiping it with a damp cloth. If necessary, use a mild detergent solution. Caution: Do not immerse the cable. Do not allow any fluid or moisture into any connector. The cable and attached devices may not function correctly if the connectors get wet. Caution: Do not clean the cable with aggressive solvents or the cable may be damaged. 5

2. Dry thoroughly. Caution: Inspect this component thoroughly after cleaning and before reuse. Check for insulation damage, such as brittleness, cracking, or bare spots. Do not use this component if it appears to be damaged.

12 Specifications Length Environmental conditions Operational Storage Safety information

3.0 m (9.8 ft) 15°C to 30°C (59°F to 86°F), 30% to 75% relative humidity (noncondensing) 15°C to 30°C (59°F to 86°F) Compliance to IEC 60601-1, IEC 60601-2-2

13 Warranty Limited Warranty Epix Therapeutics warrants each new EGM cable supplied by Epix Therapeutics to be free from defects in material and workmanship under normal use and service. The sole obligation and liability of Epix Therapeutics under this warranty is limited to, at its option, the replacement at its factory of any such product which proves defective within 12 months (limited warranty) after delivery to or first use by the first end user and is found to be defective in material or workmanship by Epix Therapeutics inspection. Epix Therapeutics assumes no liability with respect to single-use instruments that are reused, reprocessed, or re-sterilized and makes no warranties, expressed or implied, including, but not limited to the warranties of merchantability or fitness for intended use with respect to such instrument. Disclaimer of Warranty and Limitation of Liability There is no express or implied warranty, including without limitation and implied warranty of merchantability or fitness for a particular purpose, on the product(s) described herein. Under no circumstances shall Epix Therapeutics or its affiliated companies, be liable for any special, direct, incidental, consequential, or other damages other than as expressly provided by specific law. Without limiting the foregoing Epix Therapeutics or its affiliated companies, shall not be liable for any special, direct, incidental, consequential, or other damages, arising out of the reuse of any product(s) labeled for single use or where reuse is prohibited by applicable law. Your Consumer rights - Australia and New Zealand Customers and Patients The language used above is in addition to, and should not be construed to, detract from any rights and remedies that a consumer may have under Australian and New Zealand consumer legislation (Your Consumer Rights). Any exclusion of direct, incidental, consequential or other damages and other warranties (including express or implied warranties of merchantability, fitness for purpose etc.) referred to above will not affect Your Consumer Rights. For Australia: “Our goods come with guarantees that cannot be excluded under the Australian Consumer Law. You are entitled to a replacement or refund for a major failure and compensation for any other reasonably foreseeable loss or damage. You are also entitled to have the goods repaired or replaced if the goods fail to be of acceptable quality and the failure does not amount to a major failure.” A written claim may be sent to the manufacturer care of Medtronic Australasia Pty Ltd at the address on the back cover of this manual.

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Epix Therapeutics 945 Stewart Drive, Suite 100 Sunnyvale, CA 94085 USA

Medtronic B.V. Earl Bakkenstraat 10 6422 PJ Heerlen The Netherlands

www.medtronic.com Medtronic Australasia Pty Ltd 2 Alma Road Macquarie Park, NSW 2113 1800 668 670 [email protected]

© 2021 Epix Therapeutics M016426C001 A 2021-04-20

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