DiamondTemp GenConnect Cable Instructions for Use

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Consult instructions for use 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. Follow instructions for use (blue)

Conformité Européenne (European Conformity). This symbol means that the device fully complies with applicable European Union acts. Authorized representative in the European Community Reorder number Lot number Manufacturer Date of manufacture Keep dry Do not use if package is damaged Temperature limit Storage temperature limit Transit temperature limit Humidity limitation

Atmospheric pressure limitation

Medical device Model number Unique Device Identifier Importer Package contents GenConnect cable Product documentation For Australia and New Zealand audiences only For Brazil audiences only For Canada audiences only

1 Device description The DiamondTemp GenConnect cable (CEDTGC100) is part of the DiamondTemp ablation system, which also includes the DiamondTemp ablation catheter, DiamondTemp RF generator, DiamondTemp irrigation tubing set, DiamondTemp catheter-to-RF generator (RFG) cable, DiamondTemp EGM cable, DiamondTemp Generator Connection Box E, DiamondTemp irrigation pump, and optional DiamondTemp foot switch. 3

The DiamondTemp ablation system is designed to deliver radiofrequency (RF) energy to the cardiac anatomy via the DiamondTemp catheter. The distal end of the nonsterile GenConnect cable has a 26-pin female connector that connects to the catheter-to-RFG cable and the proximal end has a 26-pin male connector that connects to the generator.

2 Contents of package The cable is supplied nonsterile. The package contains the following items: • One model CEDTGC100 GenConnect cable • Product documentation

3 Indications for use The DiamondTemp GenConnect cable is designed for use with the DiamondTemp ablation system. The cable operates in conjunction with the DiamondTemp RF generator and the DiamondTemp Generator Connection Box E (or compatible EPT GenConnect box). Refer to the DiamondTemp catheter instructions for the indications for use. Carefully review the specific indications, contraindications, warnings, precautions, and adverse events included with the DiamondTemp catheter before using the cable.

4 Contraindications The contraindications listed in the DiamondTemp catheter instructions apply to the use of the DiamondTemp GenConnect cable. Carefully review the specific indications, contraindications, warnings, precautions, and adverse events included with the DiamondTemp catheter before using the GenConnect cable.

5 Intended purpose The DiamondTemp GenConnect cable is intended to connect the DiamondTemp catheter to the RF generator when a generator connection box is used.

6 Intended user The intended user of this 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.

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

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

9 Warnings and precautions • • • • • • • • • • • • • • • • •

Refer to the DiamondTemp catheter instructions for warnings related to use of the DiamondTemp ablation system. Do not expose the GenConnect cable to organic solvents. The GenConnect cable is not sterile and should not be used in a sterile field. The GenConnect cable is not intended to be sterilized. Use appropriate cleaning and disinfection techniques to clean this cable before reusing. The GenConnect cable is designed for use with the DiamondTemp ablation system. Use of improper cables may cause errors in the operation of the generator and can result in hazards to the patient. Do not pull on the GenConnect cable to disconnect the cable from the generator, the connection box, or the catheter. Before use, inspect the GenConnect cable and packaging to verify that no damage has occurred. Do not use if the cable or packaging is damaged. 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. Position connecting cables to avoid contact with the patient and other electrical leads. If used in the presence of other electrical equipment, noise could be introduced into the cable. Position the cable as far away as possible from sources of potential electromagnetic interference. Do not clean the GenConnect cable by using automated cleaning processes. Do not immerse the GenConnect cable connectors in fluids. The GenConnect cable is used only in conjunction with the DiamondTemp Generator Connection Box E. (The system is also compatible with the EPT GenConnect box, an accessory of the Abbott™ EnSite™ cardiac mapping system). Consult the respective instructions to ensure correct connectivity and usage. If a serious incident related to the device occurs, immediately report the incident to the manufacturer and the applicable competent authority or regulatory body. Do not dispose of this product in the unsorted municipal waste stream. Dispose of this product according to local regulations. If you find information in this manual that is incorrect or illegible, contact your Epix Therapeutics representative or your local competent medical authority.

10 Potential adverse events The potential adverse events that may be associated with ablation procedures can vary greatly in frequency and severity and may necessitate additional medical intervention, including surgery. Carefully review the specific indications, contraindications, warnings, precautions, and adverse events included with each DiamondTemp catheter before using the DiamondTemp ablation system.

11 Directions for use Note: Refer to the DiamondTemp catheter instructions for use and DiamondTemp RF generator user manual for detailed operating instructions of the DiamondTemp ablation system. 1. Carefully remove the GenConnect cable from its packaging using standard hospital practices, and inspect the cable for damage or rough surfaces, sharp edges, or protrusions before use. 2. Refer to Figure 1 for illustration of how to connect to and operate the DiamondTemp catheter and system in conjunction with the DiamondTemp Generator Connection Box E and the Abbott EnSite™ Velocity™ or EnSite Precision™ mapping and navigation system. (The DiamondTemp system is also compatible with the EPT GenConnect box.) Refer to the respective instructions for detailed information. 3. Connect the distal end (26-pin female receptacle) of the DiamondTemp GenConnect cable to the DiamondTemp catheter-to-RFG cable. To do this, align the green connector end of the catheter-to-RFG cable to the green receptacle key of the GenConnect cable, and then push the connector into the receptacle firmly until it stops. Do not force the connectors or pin damage can occur. To disconnect, pull the connector body until it separates from the receptacle. 4. Connect the proximal end (26-pin male connector) of the DiamondTemp GenConnect cable to the DiamondTemp generator. To do this, align the green strain-relief end of the GenConnect cable connector key to the generator receptacle key, and then push the connector into the receptacle firmly until it stops. Do not force connectors or pin damage can occur. To disconnect, pull the connector body until it separates from the receptacle. 5. Connect the grey 9-pin connector to the catheter input of the DiamondTemp Generator Connection Box E (or other compatible box). 6. Connect the black 14-pin connector to the RF generator output of the DiamondTemp Generator Connection Box E (or other compatible box). 7. Confirm correct connectivity with the mapping system. 8. Connect the return pad directly to the generator.

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Figure 1. DiamondTemp Generator Connection to Mapping and Navigation System

1 14-pin twist connector to generator (via the GenConnect cable) 2 9-pin quick connector to catheter (via the GenConnect cable to the catheter-to-RFG cable) 3 DiamondTemp RF generator 4 DiamondTemp GenConnect cable 5 DiamondTemp ablation catheter 6 DiamondTemp catheter-to-RFG cable

12 Device removal and disposal At the end of the procedure, after removing the DiamondTemp catheter from the patient, disconnect the GenConnect cable from the catheter by gently pulling on the outer housings of the connectors. Do not pull on the cabling, as this may damage the cable or the catheter. Disconnect the GenConnect cable from the generator by gently pulling on the outer housing of the generator connector. Do not pull on the cabling, as this may damage the GenConnect cable or the generator. After cleaning, disinfection, or decontamination, the GenConnect cable may be reused or disposed per standard procedures for electrical cables and in accordance with local laws and regulations.

13 Cleaning To clean the GenConnect cable, use the following steps: 1. Clean the cable by wiping it with enzymatic concentrates, such as Prolystica 2x Concentrate, at 1/8 oz per gallon of tap water (0.94 g in 1 L). Caution: The connectors should not be immersed in fluids. Automated cleaning of the cable is not recommended. 2. To disinfect, use broad spectrum disinfectants like phenolics, aldehydes, or alcohols. Recommended disinfectants are Glutaraldehyde 1%, 70% Isopropyl Alcohol (IPA), sodium hypochlorite (0.1%), or equivalent. Follow the manufacturer’s instructions for use to use the disinfectant. 3. Wipe dry with a clean, soft nonlinting cloth. Caution: Do not immerse the GenConnect cable in any liquid and do not expose it to steam autoclave or ethylene oxide (EtO) sterilization.

14 Specifications Length Environmental/storage conditions

1.8 m (6.0 ft) 15°C to 30°C (59°F to 86°F), noncondensing, per standard hospital procedures for nonsterile equipment (The GenConnect cable should be stored in its original packaging before first use.)

15 Warranty Limited Warranty Epix Therapeutics warrants each new GenConnect 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 resterilized 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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