TactiSys Quartz Equipment User Manual Model PN-004 400

TactiSys™ Quartz Equipment Instructions for Use ARTEN600200737

The TactiSys™ Quartz Equipment User Manual is intended to provide the necessary information for proper operation of the TactiSys™ Quartz Equipment hardware and accessories. The TactiSys Quartz Equipment hardware and accessories are indicated for use in conjunction with a compatible contact force ablation catheter. General knowledge of cardiac ablation procedures and an understanding of the features and functions of the TactiSys Quartz Equipment hardware are a prerequisite for proper use. CAUTION: Do not operate the TactiSys Quartz Equipment hardware without having completely read and understood these instructions.

The equipment has been designed and manufactured to meet the requirements of the following safety standards: IEC 60601-1:2005 + CORR. 1:2006 + CORR. 2:2007 + A1+2012 IEC 60601-1-2:2014 IEC 60601-2-2:2009 + C1:2014

TactiSys™ Quartz Equipment Instructions for Use ARTEN600200737

Chapter 1. Introduction 5

System Description 5 What Is It? 5 TactiSys™ Quartz Equipment Hardware 5 Compatible Catheter 5 Related Components 5 Main Functionalities 6 System Interconnections and List of Accessories 6

Chapter 2. Indications for Use 7 Important Safety Information 7 Physician Training 7 Safety Precautions 7 Electromagnetic Compatibility 7 Disposal 8 Symbols 8

Chapter 3. Installation 13

Receiving, Inspecting, and Returning the System 13 Check for Completeness 13 Damage Check and Reporting 13 Setting up the System 13 TactiSys™ Quartz Equipment Hardware Installation 13 Cleaning and Disinfecting the System 14 Instructions 14

Chapter 4. TactiSys™ Quartz Equipment Components 17 Important Information 17 The TactiSys™ Quartz Equipment Hardware 17

Chapter 5. Procedures to Operate TactiSys™ Quartz Equipment 21 Switching on the TactiSys™ Quartz Equipment Hardware 21 Connecting a Compatible Catheter 21 Starting a Compatible EnSite™ Contact Force Module Procedure 21 Replacing a Compatible Catheter 21 Downloading Log Files from the TactiSys™ Quartz Equipment Hardware 22 Technical Specifications 22 Inspections and Repairs 22 Maintenance 22 Maintenance Contract 23 TactiSys™ Quartz Equipment Hardware Specifications 23 General 23 System Performances with TactiCath™ Contact Force Ablation Catheters 24 System Performances with TactiFlex™ Ablation Catheter 24 Compatibility with External Devices 24 Compatible Catheter 24 Compatible RF Generator 24 Compatible Client/ EP System 24 Environmental Conditions 25

Appendix A. Appendix A: System Interconnections 27 List of Connections 27

Appendix B. Appendix B: List of Accessories 29

Optional Accessories of TactiSys™ Quartz Equipment Hardware and their Relevant Catalogue Numbers 29

Appendix C. Appendix C: Electromagnetic Compatibility 31 Electromagnetic Emissions 31 Electromagnetic Immunity 32 RF Portable Equipment 33 Recommended Separation Distances 35

4

TactiSys™ Quartz Equipment Instructions for Use ARTEN600200737

TactiSys™ Quartz Equipment Instructions for Use ARTEN600200737

Chapter 1. Introduction System Description

5

Introduction System Description What Is It? The TactiSys™ Quartz Equipment is part of a system for percutaneous catheter radiofrequency (RF) ablation of atrial cardiac arrhythmias that allows visualization of the contact force between the tip of a compatible contact force ablation catheter and the heart wall. Use of the system to treat a specific cardiac arrhythmia is determined by the indications for use of the compatible contact force ablation catheter.

TactiSys™ Quartz Equipment Hardware The TactiSys Quartz Equipment hardware is a non-sterile active signal and data processing device that interconnects the compatible contact force ablation catheter to an external RF generator. The TactiSys Quartz Equipment hardware collects data from the catheter to compute the force and related information. TactiSys Quartz Equipment hardware operates as a server, sending contact force information to the compatible EnSite™ Contact Force Module (referred later in this document as “Client”). The TactiSys Quartz Equipment hardware is powered by a mains adapter, which is provided with the device.

Compatible Catheter The TactiSys Quartz Equipment is intended to be used with a compatible contact force ablation catheter. The combination of the two devices is referred to as the TactiCath™ Quartz Set.

Related Components The following additional components are required for RF ablation procedures and to display contact force information:

• RF generator • Irrigation pump • Client/ Compatible Electrophysiology System

– EnSite™ Cardiac Mapping System with EnSite™ Contact Force Module – EnSite™ X EP System with EnSite™ X Contact Force Module

The following illustration shows how the devices are interconnected:

6

Chapter 1. Introduction System Interconnections and List of Accessories

TactiSys™ Quartz Equipment Instructions for Use ARTEN600200737

Main Functionalities When used with a compatible contact force ablation catheter, the TactiSys™ Quartz Equipment hardware has the following main functionalities:

• Contact force calculation • Data transfer to compatible Client • Transmitting intra-cardiac signals for monitoring • Transmitting pacing signals • Transmitting RF energy to the cardiac tissue

When used with the TactiSys Quartz Equipment hardware, the EnSite Contact Force Module has the following functionalities:

• Visualization and storage of the force information coming from the catheter tip during mapping and ablation • Visualization of the contact force signal

System Interconnections and List of Accessories See Appendix A: System Interconnections for an overview of the TactiSys Quartz Equipment hardware interconnections with other devices in the electrophysiology laboratory.

TactiSys™ Quartz Equipment Instructions for Use ARTEN600200737

Chapter 2. Indications for Use Important Safety Information

7

Indications for Use TactiSys™ Quartz Equipment and accessories are indicated for use in conjunction with a compatible contact force ablation catheter. TactiSys Quartz Equipment allows the visualization of the force information coming from the catheter tip. For further information about the compatible contact force ablation catheter and its indications for use, please refer to its Instructions for Use (IFU).

Important Safety Information WARNING: A warning indicates that there is a risk of injury to the patient or user. CAUTION: A caution refers to a condition that may lead to damage or malfunction of the equipment. NOTE:

A note provides additional information.

Physician Training Cardiac ablation procedures using the TactiCath™ Quartz Set must be performed by physicians who fully understand the working principles of the TactiCath Quartz Set as described in this User Manual. Training on the TactiCath Quartz Set will be provided by St. Jude Medical personnel or by trainers accredited by St. Jude Medical, at the installation of the TactiCath Quartz Set. Physicians must be familiar with the techniques and be appropriately trained for cardiac mapping and ablation procedures and must be authorized to conduct such procedures according to the laws and guidelines enforced in their country and institutions. All mapping and ablation procedures must be performed in a fully equipped electrophysiology laboratory that is supported by appropriately trained personnel.

Safety Precautions CAUTION: This product complies with the Electromagnetic Compatibility Standard IEC 60601-1-2:2014 and needs to be installed and put into service according to Appendix C: Electromagnetic Compatibility. Certain types of mobile telecommunication equipment could potentially interfere with this product. The separation distances recommended in Appendix C: Electromagnetic Compatibility must be taken into account. This product should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, this product should be observed to verify normal operation in the configuration in which it will be used. The use of accessories and cables other than those specified or sold by the manufacturer of this product as replacement parts, may result in increased emissions or decreased immunity of this product. The equipment contains a lithium battery. Do not attempt to change, recharge, force open, or heat the battery. Do not incinerate equipment.

Electromagnetic Compatibility For information about electromagnetic compatibility, see Appendix C: Electromagnetic Compatibility.

8

Chapter 2. Indications for Use Symbols

TactiSys™ Quartz Equipment Instructions for Use ARTEN600200737

Disposal

The User Manual is recyclable. Dispose of all packaging materials as appropriate. You can also return the device to the manufacturer for disposal.

Symbols The following symbols are used on TactiSys™ Quartz Equipment components: Follow instructions for use

Consult Instructions for Use

Follow Instructions for Use on this Website

Caution

The applied part of the TactiCath™ Quartz Set is type CF for direct cardiac application, and is defibrillator proofed

Affixed to this device in accordance with European Council Directives 2012/19/EU. These directives call for separate collection and disposal of electrical and electronic equipment. Sorting such waste and removing it from other forms of waste lessens the contribution of potentially toxic substances into municipal disposal systems and into the larger ecosystem. Return the device to St. Jude Medical at the end of its operating life. Keep dry

TactiSys™ Quartz Equipment Instructions for Use ARTEN600200737

Fragile; handle with care

This way up

Temperature limitation

Connection of an HF isolated patient circuit

Power-off

Power-on

USB connection

Equipotential ground connection

Chapter 2. Indications for Use Symbols

9

10

Chapter 2. Indications for Use Symbols

TactiSys™ Quartz Equipment Instructions for Use ARTEN600200737

Class II equipment

Manufacturer

Authorized Representative in European Community

Conformité Européenne (European Conformity). Affixed in accordance with European Council Directive 93/42/EEC (NB 2797) and 2011/65/EU. Hereby, St. Jude Medical declares that this device is in compliance with the essential requirements and other relevant provisions of this directive.

Date of Manufacture

Quantity

Equipment

Do not use if package is open or damaged

Catalogue Number

Serial Number

TactiSys™ Quartz Equipment Instructions for Use ARTEN600200737

Chapter 2. Indications for Use

Lot Number

RF Cable

Radiofrequency Cable

For Use With

CE Mark

Adapter

Intertek Safety Agency Certification Mark

Medical Electrical Equipment

Computer network

CAUTION: Federal (US) law restricts this device to sale by or on the order of a physician

Symbols

11

12

Chapter 2. Indications for Use Symbols

TactiSys™ Quartz Equipment Instructions for Use ARTEN600200737

TactiSys™ Quartz Equipment Instructions for Use ARTEN600200737

Chapter 3. Installation Receiving, Inspecting, and Returning the System

13

Installation Receiving, Inspecting, and Returning the System Check for Completeness After opening the TactiSys™ Quartz Equipment box PN-004 400, check whether you have received all of the following components: Qty 1 1 1 4a 1 1b

NOTE:

Name / Description TactiSys™ Quartz Equipment hardware Ethernet cable 3 m Mains adapter Mains cord Equipotential cable User Manual a. b.

US, Australian, EU, and UK mains cords are included in the box. Appropriate User Manual depends on your geographic location.

The TactiSys Quartz Equipment hardware shall be used with either of the following RF generator cable, which will be delivered in a separate box: Catalogue No. PN-004 515 TSQ-RF-TFSE-CBL

Name / Description TactiSys™ Quartz Radiofrequency cable – Ampere™ Generator TactiSys™ Quartz, TactiFlex™ Radiofrequency cable

The RF generator cable is required to connect the TactiSys Quartz Equipment hardware to the RF generator. An ablation procedure is not possible without the RF generator cable. Additional accessories may be used in conjunction with the TactiSys Quartz Equipment hardware. A list of optional accessories is given in Appendix B: List of Accessories.

Damage Check and Reporting When you receive the device, you should check for damage caused during the shipment. In case the device was damaged during shipment, you should:

• Notify the shipping agent immediately. • File a damage report to document claims for damages.

Setting up the System TactiSys™ Quartz Equipment Hardware Installation Location The TactiSys Quartz Equipment hardware should be placed outside of the sterile field in the electrophysiology laboratory.

14

Chapter 3. Installation Cleaning and Disinfecting the System

TactiSys™ Quartz Equipment Instructions for Use ARTEN600200737

The Client should be placed outside the sterile field in the electrophysiology laboratory or in the control room. The site controlling the device should have policies in place prescribing the physical safety and security of the devices in the electrophysiology laboratory. For example, physically securing devices and information should include policies that limit physical access, securing equipment in locked rooms, managing access to secured rooms, and restricting the ability to remove devices from a secure area. WARNING: Do not obstruct the ventilation grid located on the bottom and the top of the TactiSys™ Quartz Equipment hardware case. CAUTION: To avoid risk of damaging the TactiSys™ Quartz Equipment, make sure that the supporting surface is horizontal, stable, and free from vibrations.

Procedure To set up TactiSys™ Quartz Equipment, proceed as follows: 1. Optional: Assemble the TactiSys Quartz Equipment hardware on the TactiSys™ Quartz Mounting Bracket (see TactiSys Quartz Equipment Mounting Bracket Instructions) and fix the mount close to the electrophysiology laboratory operation table. 2. Connect the mains adapter provided to the appropriate mains cord, and then to the TactiSys Quartz Equipment hardware power socket. Connect the mains cord to the mains power supply. 3. Connect the TactiSys Quartz Equipment hardware to the compatible Client using the Ethernet cable. 4. Connect the green connector of the RF cable to the TactiSys Quartz Equipment hardware RF cable socket, and the other connector into the RF generator. Radiofrequency cable PN-004 515 to be used with TactiCath Contact Force Ablation Catheters Radiofrequency cable TSQ-RF-TFSE-CBL to be used with TactiFlex Ablation Catheters 5. Connect an equipotential cable to the TactiSys Quartz Equipment hardware equipotential socket. NOTE:

NOTE:

An overview of all the system interconnections can be found in Appendix A: System Interconnections . All combinations of equipment must be in compliance with IEC 60601-1 (clause 16) Standard systems requirements. Anyone who interconnects various types of medical equipment configures a medical system and is therefore responsible for ensuring that the system complies with the requirements of system standard IEC 60601-1 (clause 16). Inspect the Ethernet cable and verify the cable is intact between the TactiSys Quartz System and the Client connection.

NOTE:

To prevent dust from contaminating the devices when no optical cables are connected, always cover unused optical cable ports with the protection cap. If there is no or intermittent output of the force sensor, carefully clean the optical connector using a lint-free swab soaked with 99% isopropyl alcohol solution and then dry the optical connector with a new lint-free swab without alcohol. Use only the mains adapter, cables, and other accessories provided by St. Jude Medical with the TactiSys Quartz Equipment hardware (see Appendix B: List of Accessories).

Cleaning and Disinfecting the System Instructions To avoid complications due to contamination of the system components, clean and decontaminate them before and after use.

Chapter 3. Installation

TactiSys™ Quartz Equipment Instructions for Use ARTEN600200737

Cleaning and Disinfecting the System

15

The following table shows how to clean and disinfect the system components: Do … • Switch the TactiSys™ Quartz Equipment hardware off and disconnect it from mains adapter. • Clean the surfaces with soap and a soft cloth dampened with water. • Prevent moisture from entering the devices. • Use standard hospital cleaning practices.

Do not … • Use flammable and explosive agents to clean and disinfect the devices. • Use acetone-containing agents to clean the devices. • Use sterilization methods (eg, gas, steam, hot air).

WARNING: Electrical shock hazard: The TactiSys™ Quartz Equipment hardware must be switched off and disconnected from the mains adapter before it is cleaned. No liquid should enter the equipment. Make sure that any remaining liquid on the devices and cables has dried before switching the system on.

16

Chapter 3. Installation Cleaning and Disinfecting the System

TactiSys™ Quartz Equipment Instructions for Use ARTEN600200737

Chapter 4. TactiSys™ Quartz Equipment Components

TactiSys™ Quartz Equipment Instructions for Use ARTEN600200737

Important Information

17

TactiSys™ Quartz Equipment Components Important Information WARNING: Do not spill liquid on TactiSys™ Quartz Equipment hardware components. CAUTION: To avoid malfunction, cables and accessories should be visibly inspected prior to use and plug-in/unplug of cables should be carried out with care. Cables with damaged insulation should not be used. To avoid damage, do not use acetone-containing agents to clean the TactiSys Quartz Equipment hardware. The device surface, including labeled panels, can be cleaned using a soft cloth with soap and water or soft detergents. To avoid system malfunction, do not connect the interface connector (optical fiber) for fiber optics to an external voltage source.

Adverse Events See adverse event information in the IFU of the compatible contact force ablation catheter that you intend to use with TactiSys Quartz Equipment hardware. For a full list of compatible devices, refer to the Compatibility with External Devices section. NOTE:

To maintain system isolation, only medical electrical equipment certified to IEC 60601-1 may be connected to the TactiSys Quartz Equipment hardware. Respect the minimum safety distance between the electrical devices and the patient according to Appendix C: Electromagnetic Compatibility.

The TactiSys™ Quartz Equipment Hardware Connections of the TactiSys™ Quartz Equipment Hardware to the Other Parts of the System The TactiSys™ Quartz Equipment Hardware is Connected to the ...

By ...

Compatible Client (26)

An Ethernet cable

RF Generator (27)

An electrical interface cable connected to the rear panel (24)

Compatible contact force ablation catheter (sold separately)

The connection cable (3) of the compatible contact force ablation catheter, consisting of one electrical connector (5) and one optical connector (6)

NOTE:

See Appendix A: System Interconnections for item numbering.

Power Supply The TactiSys Quartz Equipment hardware is powered by the power cable provided by St. Jude Medical, consisting of mains adapter and mains cord.

18

Chapter 4. TactiSys™ Quartz Equipment Components

TactiSys™ Quartz Equipment Instructions for Use ARTEN600200737

Important Information

TactiSys™ Quartz Equipment Hardware Front Panel

Item number

Part

Function

7

Reset Button

To reset the force values to baseline

8

Power indicator

Lit when the TactiSys™ Quartz Equipment hardware is powered

9

Electrical socket for compatible contact force ablation catheter

Accepts compatible contact force ablation catheter electrical connector

10

Optical socket for compatible contact force ablation catheter

Accepts compatible contact force ablation catheter optical connector

Chapter 4. TactiSys™ Quartz Equipment Components

TactiSys™ Quartz Equipment Instructions for Use ARTEN600200737

Important Information

19

TactiSys™ Quartz Equipment Hardware Rear Panel

Item Number

Part

Function

11

ON/OFF switch

Switch on/off TactiSys™ Quartz Equipment hardware

12

Power socket

Connection to mains power supply (via combination of mains cord and mains adapter)

13

Ethernet socket

Connection to Client/ EP System to display contact force information

14

USB port

Accept mass storage device

15

RF cable socket

Connection to the “catheter” connector of the RF generator

16

X1 serial port

Nonfunctional

17

Equipotential socket

For equalization of the ground potential

20

Chapter 4. TactiSys™ Quartz Equipment Components Important Information

TactiSys™ Quartz Equipment Instructions for Use ARTEN600200737