Medtronic CEDTGC100 Instructions for Use

DiamondTemp™

GenConnect Cable

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™

1 Glossary of symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

2 Device description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

3 Indications for use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

4 Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

5 Warnings and precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

6 Potential adverse events . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

7 Directions for use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

8 Device removal and disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

9 Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

10 How supplied . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

11 Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

12 Limited warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

1 Glossary of symbols

The following table defines symbols that are used on packaging and product labeling. Refer to the labels to determine which symbols apply to this product and for the product-specific information, such as the date of manufacture.

Symbol

Standard/Standard title or reference Symbol title/Reference number Explanatory text

ISO 15223-1

21 CFR 801.109

EN 50419

Consult instructions for use (clause 5.4.3)

Prescription only USA Federal law restricts this device to sale by or on

Consult instructions for use at this website: www.medtronic.com/manuals

the order of a licensed healthcare practitioner.

Recycle: Electronic Equipment Do NOT throw in trash.

IEC 60601-1

ISO 15223-1

Follow instructions for use (Table D2, Symbol 10)

Catalog number (clause 5.1.6)

Batch code (clause 5.1.5)

Manufacturer (clause 5.1.1)

Date of manufacture (clause 5.1.3)

Keep Dry (clause 5.3.4)

Do not use if package is damaged (clause 5.2.8)

Temperature limit (clause 5.3.7)

N/A Storage temperature limit Indicates the required temperature range for storing

N/A Transit temperature limit Indicates the required temperature range for trans-

ISO 15223-1

Humidity limitation (clause 5.3.8)

Atmospheric pressure limitation (clause 5.3.9)

N/A Package contents Indicates the components included in the device

N/A GenConnect cable Indicates that a GenConnect cable is included in the

ISO 7000

21 CFR 801.109: United States Code of Federal Regulations, Title 21, Food and Drugs

EN 50419: Marking of electrical and electronic equipment in accordance with Article 11(2) of Directive 2002/96/EC (WEEE)

IEC 60601-1: Medical electrical equipment – Part 1: General requirements for basic safety and essential performance

ISO 15223-1: Medical devices – Symbols to be used with medical device labels, labeling and information to be supplied

ISO 7000: Graphical symbols for use on equipment

Product documentation (symbol 0419)

Refer to instruction manual/booklet (blue symbol)

Indicates the manufacturer’s catalog number so the device can be identified

Indicates the manufacturer’s batch code so that the batch or lot can be identified

Indicates the medical device manufacturer

Indicates the date when the medical device was manufactured

Indicates a medical device that needs to be protected from moisture

Indicates a medical device that should not be used if the package has been damaged or opened

Indicates the temperature limits to which the medical device can be safely exposed

the device

porting the device

Indicates the range of humidity to which the medical device can be safely exposed

Indicates the range of atmospheric pressure to which the medical device can be safely exposed

package

device package Indicates that product documentation is included in

the device package

2 Device description

The Medtronic DiamondTemp GenConnect cable 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, and DiamondTemp irrigation pump.

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 (model CEDTGC100) 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. The length of the cable is 1.8 m (6.0 ft).

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 generator and an external GenConnect box (or similar connection box). Refer to the DiamondTemp catheter instructions for the indications for use. Carefully review the specific indications, contraindications, warnings, precautions, 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, adverse events, included with the DiamondTemp catheter before using the GenConnect cable.

5 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 GenConnect box, or the catheter.

• Store in a cool, dry place.

• 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 a GenConnect box (or similar connection box) with a compatible mapping and navigation system (such as 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.

• If you find information in this manual that is incorrect or illegible, contact your Medtronic representative.

6 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.

7 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 a compatible mapping and navigation system and GenConnect box. Refer to the respective instructions for detailed information.

3. Connect the distal end (26-pin female receptacle) of the 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 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 GenConnect box.

6. Connect the black 14-pin connector to the RF generator output of the GenConnect box.

7. Confirm correct connectivity with the mapping system.

8. Connect the return pad directly to the generator.

Figure 1. DiamondTemp Generator Connection to Mapping and Navigation System

1 DiamondTemp ablation catheter 2 Catheter-to-RFG cable 3 9-pin quick connector 4 GenConnect cable 5 DiamondTemp RF generator

6 Ablation return pad 7 14-pin twist connector 8 GenConnect box (oriented upside down, for purposes of illustration) 9 Amplifier

8 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.

9 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.

10 How supplied

The GenConnect cable is supplied nonsterile along with the required product documentation. If the packaging is damaged, do not use the product and contact a Medtronic representative.

11 Storage

The GenConnect cable should be stored in its original packaging before first use. Store in a cool and dry place, in a 15°C to 30°C (59°F to 86°F) noncondensing environment, per standard hospital procedures for nonsterile equipment.

12 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, and GenConnect cable, 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.