Medtronic CEDTGCB100 Instructions for Use

DiamondTemp™ CEDTGCB100

Generator Connection Box E

Instructions for Use

Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.

Medtronic, Medtronic with rising man logo, and Medtronic logo are trademarks of Medtronic. Third-party trademarks (“TM*”) belong to their respective owners. The following list includes trademarks or registered trademarks of a Medtronic entity in the United States and/or in other countries.

DiamondTemp™

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

Follow instructions for use (blue)

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

Serial number

Manufacturer

Date of manufacture

Manufactured in

Keep dry

Fragile, handle with care

Defibrillation-proof, type CF applied part

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

China RoHS

Compliance mark indicating conformance to applicable standards

Catheter-side GenConnect cable connector

RFG-side GenConnect cable connector

Primary cardiac mapping 52-pin cable connector

Secondary cardiac mapping 9-pin EGM cable connector

Package contents

Generator connection box

Product documentation

Prescription only

Conformité Européenne (European Conformity). This symbol means that the device fully complies with applicable European Union acts.

International Protection (IP) Code

Authorized representative in the European Community

For Brazil audiences only

For Canada audiences only

For Australia and New Zealand audiences only

1 Device description

The Medtronic DiamondTemp Generator Connection Box E (CEDTGCB100) is a signal filtration device used to connect the DiamondTemp ablation catheter and DiamondTemp RF generator to the Abbott EnSite™ Velocity™ or EnSite Precision™ cardiac mapping and navigation system. The box transmits intracardiac signals from the catheter electrodes to a compatible 3D mapping and navigation system without any signal distortion or interference by the generator.

The Generator Connection Box E is connected to the catheter and generator through two connectors via the GenConnect cable. The third plug on the box is used to connect to the EnSite™ Amplifier via the SJM™ interconnect cable. If an SJM™ interconnect cable is unavailable, the box can be connected to the amplifier via the DiamondTemp EGM cable (the fourth plug on the box).

Note: Do not connect the Generator Connection Box E to an EP recording system. The proper filtration for that functionality is not contained within the box.

The DiamondTemp Generator Connection Box E is supplied separately for use with the DiamondTemp RF generator. The Generator Connection Box E should be used only with the DiamondTemp ablation system and Abbott EnSite™ cardiac mapping system. (The DiamondTemp ablation system is also compatible with the Abbott EPT GenConnect box, if available.)

Figure 1. DiamondTemp Generator Connection Box E

1 Generator Connection Box E 2 9-pin quick connector (gray) to catheter 3 Secondary 9-pin EGM connector (green) to EnSite™ RecordConnect 4 Primary 52-pin connector (black) to EnSite™ Amplifier 5 14-pin twist connector (red) to RF generator

2 Contents of package

The Generator Connection Box E is supplied nonsterile. The package contains the following items:

• One model CEDTGCB100 Generator Connection Box E

• 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 Generator Connection Box E provides filtration and transmits the DiamondTemp catheter intracardiac signals to a compatible 3D mapping and navigation 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 Medtronic representative.

6 Warnings and precautions

Review the system documentation – The Generator Connection Box E 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.

Inspect the package – Carefully inspect the package before opening. If the package has been damaged or opened, do not use and contact your Medtronic representative.

Inspect the component – Inspect the component thoroughly. Do not use the component if it appears to be damaged.

Sterilization – The Generator Connection Box E is supplied nonsterile and is not intended to be sterilized. Do not expose the box to

steam autoclave or ethylene oxide (EtO) sterilization.

Product compatibility – For use only with the DiamondTemp ablation system and the EnSite™ Velocity™ or EnSite Precision™ cardiac mapping system. Use with other systems has not been assessed, and may compromise patient or operator safety.

Do not modify – Do not modify this equipment. Modifications may reduce system effectiveness and impact patient health.

Primary and secondary connectors – Do not connect the Generator Connection Box E to the EnSite™ Amplifier with both the

primary and secondary connectors. Only connect using one of the connector options.

Use with other equipment – Using this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, observe the equipment to verify that it is operating normally.

Serious incident – If a serious incident related to the device occurs, immediately report the incident to Medtronic and the applicable competent authority or regulatory body.

Cleaning – Do not immerse in any liquid. Do not use an automated cleaning or disinfection process with this component.

Disposal – Do not dispose of this product in the unsorted municipal waste stream. Dispose of this product according to local

regulations.

Technical manual information – If you find information in this manual that is incorrect or illegible, contact your Medtronic representative or your local competent medical authority.

7 Adverse events

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

8 Directions for use

Note: Inspect the component before use. Do not use this component if it appears to be damaged.

Complete the following steps to connect the Generator Connection Box E. (The instructions and product figure depict a generalized connection; exact configurations may differ.) For additional information on using the Generator Connection Box E with the RF generator, see the DiamondTemp RF Generator User Manual.

1. Connect the Generator Connection Box E to the DiamondTemp ablation catheter and RF generator using the DiamondTemp GenConnect and catheter-to-RFG cables (Figure 2).

Figure 2. Generator Connection Box E Connections to RF Generator and Catheter

1 DiamondTemp Generator Connection Box E 2 DiamondTemp ablation catheter 3 DiamondTemp RF generator 4 DiamondTemp GenConnect cable

2. Connect the Generator Connection Box E to the EnSite™ Amplifier, using one of the following options. (Refer also to the applicable EnSite™ instructions for use.) For either connection option, a DiamondTemp EGM cable must be connected from the

5 DiamondTemp catheter-to-RFG cable 6 14-pin twist connector (red) to RF generator 7 9-pin quick connector (gray) to catheter

back of the RF generator to the EP recording system. If using the secondary connection option (Figure 4), two EGM cables are needed.

Caution: Do not connect the Generator Connection Box E to the EnSite™ Amplifier with both the primary and secondary connectors. Only connect using one of these connection options.

Primary connection option: Using the SJM™ interconnect cable, connect the 52-pin connector on the Generator Connection Box E to the EnSite™ Amplifier (Figure 3). (If the SJM™ interconnect cable is not available, use the secondary connection option shown in Figure 4.)

Figure 3. Generator Connection Box E Primary Connection with SJM™ Cable

1 SJM™ interconnect cable 2 Primary 52-pin connector (black) to EnSite™ Amplifier

3 Generator Connection Box E 4 EnSite™ Amplifier

To disconnect the Generator Connection Box E after the procedure, unplug the box from the catheter, generator, and EnSite™ Amplifier.

Secondary connection option: If an SJM™ interconnect cable is not available, connect a DiamondTemp EGM cable to the 9-pin connector on the Generator Connection Box E (Figure 4) and complete the following steps:

1. Connect the EGM cable pins to a catheter input module of the EP recording system. The D1 pin on the EGM cable may be skipped, as signals from the most distal catheter electrode are not used for navigation.

2. Connect the catheter input module of the EP recording system to the EnSite™ RecordConnect module.

3. Connect the cables on the RecordConnect module to the EnSite™ Amplifier and configure EnSite™ software settings appropriately. (There are different RecordConnect modules for different EP recording systems.)

Figure 4. Generator Connection Box E Secondary Connection with EGM Cable

1 DiamondTemp EGM cable 2 Secondary 9-pin EGM connector (green) to EnSite™

RecordConnect

3 Generator Connection Box E

5 EnSite™ RecordConnect 6 EnSite™ Amplifier 7 EP system amplifier 8 DiamondTemp EGM cable from RF generator

4 EP recording system

To disconnect the Generator Connection Box E after the procedure, unplug the box from the catheter, generator, and EnSite™ Amplifier.

9 Cleaning and disposal

After cleaning, the Generator Connection Box E may be reused or disposed per standard procedures in accordance with local laws and regulations.

The Generator Connection Box E is intended to be cleaned between uses. The box must be protected from moisture, contamination, and contact with flammable or explosive substances. The box surface may be cleaned with non-flammable and non-explosive agents only, according to the following steps.

1. Before cleaning, disconnect the Generator Connection Box E from the RF generator and all other devices.

2. Wipe the box with a clean, soft, nonlinting cloth dampened with soapy water solution. Caution: Do not immerse the Generator Connection Box E. Do not allow any fluid or moisture into any connector. The box and

attached devices may not function correctly if the connectors get wet.

3. Wipe again with distilled or sterilized water.

4. Wipe dry with a clean, soft, nonlinting cloth.

5. To disinfect, use broad spectrum disinfectants like phenolics, aldehydes, or alcohols. Recommended disinfectants are Glutaraldehyde 2.4%, 70% IPA, sodium hypochlorite (0.1%), or equivalent. Follow the manufacturer’s instruction for use to use the disinfectant.

Caution: Inspect this component thoroughly after cleaning and before reuse. Do not use this component if it appears to be damaged.

10 Specifications

Environmental conditions

Operational 15°C to 30°C (59°F to 86°F), 30% to 75% relative humidity (non-

condensing)

Storage 15°C to 30°C (59°F to 86°F)

Safety information Compliance to IEC 60601-1, IEC 60601-1-2,

IEC 60529 (IPX0 rating; not water resistant)

11 Limited warranty

The following limited warranty applies to customers within the United States only:

A. This limited warranty provides the following assurance to the customer of the Medtronic DiamondTemp RF generator, irrigation pump, GenConnect cable, and Generator Connection Box E, with reusable parts (foot switch, ethernet cable, and power cord), hereafter collectively referred to as the DiamondTemp ablation system. Subject to the limitations herein, Medtronic warrants the DiamondTemp ablation system sold to the customer will be free from defects in materials and workmanship under normal usage for a period of 12 months from the delivery date at the customer’s facility.

B. Should the DiamondTemp ablation system fail to meet the above warranty, Medtronic will at its option, repair or replace such DiamondTemp ablation system, or any portion thereof. For the limited warranty to apply, the following conditions must be met:

(1) Medtronic must be notified of and confirm the failure of the alleged defect within 60 days after discovery of the defect.

(2) The DiamondTemp ablation system must not have been repaired or altered outside of authorized personnel at Medtronic.

(3) THE DIAMONDTEMP ABLATION SYSTEM MUST BE USED IN ACCORDANCE WITH LABELING AND NOT ALTERED OR SUBJECTED TO MISUSE, ABUSE, IMPROPER HANDLING, OR ACCIDENT, INCLUDING, BUT NOT LIMITED TO, FIRE, FLOOD OR NATURAL DISASTERS.

C. At the discretion of Medtronic, parts or assemblies used or installed as part of the DiamondTemp ablation system may be either new or rebuilt of equal or improved quality. All parts removed or replaced during maintenance become the property of Medtronic.

D. This limited warranty is limited to its express terms. In particular:

(1) Except as expressly provided by this limited warranty, MEDTRONIC EXPRESSLY DISCLAIMS ANY REPRESENTATION OR WARRANTY OF ANY KIND, EXPRESS OR IMPLIED, WHETHER AS TO MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, OR ANY OTHER MATTER. THE REMEDIES SET FORTH IN THIS WARRANTY ARE THE EXCLUSIVE REMEDIES AVAILABLE TO THE CUSTOMER OR ANY THIRD PARTY FOR BREACH OF WARRANTY. MEDTRONIC SHALL HAVE NO LIABILITY TO ANY PERSON FOR INCIDENTAL, CONSEQUENTIAL, OR PUNITIVE DAMAGES OF ANY DESCRIPTION, WHETHER ARISING OUT OF WARRANTY, OTHER CONTRACT, TORT, OR OTHERWISE.

(2) Except as expressly provided by this limited warranty, MEDTRONIC IS NOT RESPONSIBLE FOR ANY DIRECT, INDIRECT, INCIDENTAL, OR CONSEQUENTIAL DAMAGES BASED ON ANY DEFECT, MALFUNCTION, OR FAILURE OF THE DEVICE TO FUNCTION WITHIN NORMAL TOLERANCE, WHETHER THE CLAIM IS BASED ON WARRANTY, CONTRACT, TORT, OR OTHERWISE.

E. The exclusions and limitations set out above are not intended to, and should not be construed so as to contravene mandatory provisions of applicable law. If any part or term of this limited warranty is held to be illegal, unenforceable, or in conflict with applicable law by a court of competent jurisdiction, the validity of the remaining portions of the limited warranty shall not be affected, and all rights and obligations shall be construed and enforced as if this limited warranty did not contain the particular part or term held to be invalid. This limited warranty gives the customer specific legal rights. The customer may also have other rights that vary from state to state.

F. No person has any authority to bind Medtronic to any representation, condition, or warranty except this limited warranty.

G. This limited warranty is not applicable to accessories or products used with the DiamondTemp ablation system unless specifically noted.

Medtronic, Inc.

*M011451C001*

710 Medtronic Parkway Minneapolis, MN 55432 USA www.medtronic.com +1 763 514 4000