TactiSys User Manual Rev B March 2016

The TactiSys™ Quartz Equipment User Manual is intended to provide the necessary information for proper operation of the TactiSys™ Quartz Equipment hardware and TactiSoft™ software and accessories. The TactiSys Quartz Equipment hardware and accessories are indicated for use in conjunction with a TactiCath™ Quartz 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 attempt to operate the device prior to completely reading and understanding the applicable User Manual. Federal (USA) law restricts this device to sale by or on the order of a physician.

The equipment has been designed and manufactured to meet the requirements of the following safety standards: IEC 60601-1 (2005), IEC 60601-1-2 (2007), IEC 60601-2-2 (2009).

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Table of contents 1. Introduction ...5 1.1 System description ... 5 1.2 System interconnections and list of accessories ... 9 2. Indications for use...9 3. Important safety information ...10 3.1 Physician training ... 10 3.2 Safety precautions ... 10 4. Symbols ...11 5. Installation ...14 5.1 Receiving, inspecting and returning the system ... 14 5.2 Setting up the system ... 15 5.2.1 TactiSys™ Quartz Equipment hardware installation... 15 5.2.2 TactiSoft™ software installation ... 16 5.2.3 TactiSoft™ software license ... 16 5.3 Instructions and performance tests at operating site ... 17 5.4 Cleaning and disinfecting the system... 18 6. TactiSys™ Quartz Equipment Components ...19 6.1 Important information ... 19 6.2 The TactiSys™ Quartz Equipment Hardware ... 20 6.3 Personal computer hosting TactiSoft™ Software ... 23 6.4 User Interface: TactiSoft™ Software... 23 6.4.1 Welcome Screen... 23 6.4.2 Procedure Screen ... 24 6.4.3 Settings Screen ... 32 6.4.4 Library Screen ... 36 6.4.5 Technical Services Screen ... 39 7. Procedures to operate TactiSys™ Quartz Equipment ...43 7.1 Switching on the TactiSys™ Quartz Equipment hardware ... 43 7.2 Starting the TactiSoft™ software ... 44 7.3 Connecting a TactiCath™ Quartz Catheter... 44 7.4 Starting a TactiCath™ Quartz Catheter procedure ... 45 7.5 Performing a TactiCath™ Quartz Catheter procedure ... 45 7.5.1 Settings... 46 7.5.2 Resetting the force values to baseline... 46 7.5.3 Ablation ... 48 7.5.4 Take a Screenshot ... 50 7.5.5 End procedure ... 51 7.6 Replacing a TactiCath™ Quartz Catheter ... 52 7.7 Downloading log files from the TactiSys™ Quartz Equipment Hardware ... 52 8. Error overview ...53 9. Technical specifications ...60 9.1 Technical safety inspections ... 60

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9.2 Repairs ... 60 9.3 Maintenance ... 60 9.3.1 Maintaining the system ... 60 9.3.2 Maintenance contract ... 61 9.4 TactiSys™ Quartz Equipment Hardware Specifications... 61 9.4.1 General ... 61 9.4.2 System performances ... 62 9.4.3 Compatibility with external devices ... 62 9.4.4 Environmental conditions ... 63 Appendix A: Interconnections of the TactiCath™ Quartz Set ...64 List of connections ... 65 Appendix B: List of accessories ...66 Appendix C: Electromagnetic compatibility ...67 Electromagnetic emissions ... 67 Electromagnetic immunity... 67 RF portable equipment ... 69 Recommended separation distances ... 70

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1. Introduction 1.1 System description What is it? The TactiSys™ Quartz Equipment is a system for percutaneous catheter radiofrequency (RF) ablation of atrial cardiac arrhythmias that allows visualization of the contact force between TactiCath™ Quartz Catheter tip and the heart wall. Use of the system to treat a specific cardiac arrhythmia is determined by the intended use of the TactiCath Quartz Catheter (see below). Components The TactiSys Quartz Equipment is composed of two elements, the TactiSys™ Quartz Equipment hardware and TactiSoft™ software. Notes: The TactiSys Quartz Equipment is exclusively compatible with TactiCath Quartz Catheter, the device applied to the patient. TactiSys Quartz Equipment hardware may be operated either with TactiSoft software or with the EnSite™ Contact Force Module, or both.

• TactiSys™ Quartz Equipment Hardware The TactiSys Quartz Equipment hardware is a non-sterile active signal and data processing device that interconnects the TactiCath Quartz 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, i.e. it sends the processed contact force information to an external Client upon request, such as a dedicated personal computer hosting TactiSoft software or the 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.

• TactiSoft™ Software TactiSoft software displays the force information received from the TactiSys Quartz Equipment hardware. The TactiSoft software is installed on a dedicated personal computer and communicates with the TactiSys Quartz Equipment hardware through an Ethernet connection.

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Compatible catheter The TactiSys™ Quartz Equipment is intended to be used with the TactiCath™ Quartz Contact Force Ablation Catheter. The combination of the two devices is referred to as the TactiCath™ Quartz Set.

• TactiCath™ Quartz Catheter with force sensor The TactiCath Quartz Contact Force Ablation Catheter is a multi-electrode irrigated catheter with a deflectable tip designed to allow electrophysiological mapping of the heart and when connected to an RF generator, to transmit radiofrequency current to the catheter tip electrode for the purpose of ablation. The catheter tip has an integrated force sensor that allows, when connected with the TactiSys Quartz Equipment, real-time visualization of the catheter tip contact force. Related components The following additional components are required to operate the TactiCath Quartz Set:

• RF generator • Irrigation pump • Dedicated personal computer with screen to run TactiSoft™ software and / or the EnSite™ Contact Force Module. Note: The additional components are not part of the TactiCath Quartz Set. Please refer to section 9.4.3 for detailed specifications.

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Illustration The following illustrations show how the different components of the TactiCath™ Quartz Set and the additional components are interconnected (including the EnSite™ Contact Force Module):

• TactiCath™ Quartz Set integrated in the electrophysiology laboratory system

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• Integration when using the EnSite™ Contact Force Module

Main functionalities When used with the TactiCath™ Quartz Catheter, the TactiSys™ Quartz Equipment hardware has the following main functionalities: • Contact Force calculation • Data transfer to 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, TactiSoft™ software 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 Additional feature: Force measurement The TactiCath™ Quartz Set differs from other existing percutaneous catheter ablation systems because it allows objective real-time measurement of the contact force between the catheter tip and the heart wall. Why force measurement? Applying the right force is important in percutaneous catheter ablation. Excessive contact may result in perforation and cause severe complications for the patient. Insufficient contact may result in an ineffective procedure as the lesion remains superficial and does not achieve the required electrical isolation.

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1.2 System interconnections and list of accessories Overview An overview of the interconnections and components of the TactiCath™ Quartz Set is given in Appendix A: Interconnections of the TactiCath™ Quartz Set.

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

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3. Important safety information A warning indicates that there is a risk of injury to the patient or user. A caution refers to a condition that may lead to damage or malfunction of the equipment. A note provides additional information.

3.1 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 the USA and their institutions. All mapping and ablation procedures must be performed in a fully equipped electrophysiology laboratory that is supported by appropriately trained personnel.

3.2 Safety precautions Cautions This product complies with the Electromagnetic Compatibility Standard IEC 60601-1-2:2007 and needs to be installed and put into service according to the section "Electromagnetic compatibility" provided in this document. Certain types of mobile telecommunication equipment could potentially interfere with this product. The separation distances recommended in the section "Electromagnetic compatibility" of this document 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. Disposal The User Manual is recyclable. Dispose of all packaging materials as appropriate. You can also return the device to the manufacturer for disposal. Electromagnetic compatibility For information on electromagnetic compatibility, see Appendix C: Electromagnetic compatibility.

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4. Symbols The following symbols are used on TactiSys™ Quartz Equipment components:

Follow instructions for use.

Caution - Safety symbol used to highlight the fact that there are specific warnings or precautions associated with the device, which are not otherwise found on the label. 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 2002/96/EC. 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

Fragile; handle with care

This way up

Temperature limitation

Connection of an HF isolated patient circuit

Power-off

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Power-on

USB connection

Equipotential ground connection

Class II equipment

Manufacturer

Date of Manufacture

Quantity

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

Equipment

Equipment

Do not use if package is damaged

Consult Instructions for Use

Display Workstation

Catalogue Number

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Serial Number

Lot Number

Integration Module

RF Cable

For Use With

Analog Output Cable

Transport Case

CE Mark

Notified body CE mark

0086 Pack

Adapter

Software

ETL Listed Conforms to UL STD 60601-1 IEC STD 60601-11 Certified to CAN/CSA STD C22.2 NO. 601.1

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5. Installation 5.1 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

Name / Description

1

TactiSys™ Quartz Equipment hardware

1

Ethernet cable 3 m

1 4

Mains adapter a

1

Mains cord Equipotential cable

Note a: US, Australian, EU, and UK mains cords are included in the box. The TactiSoft™ software and its dedicated personal computer will be delivered in a separate box: Qty

Name / Description

1

TactiSoft software

1

Dedicated personal computer

According to the RF generator available in the electrophysiology laboratory, the TactiSys Quartz Equipment hardware shall be used with one of the following RF generator cables, which will be delivered in a separate box: Catalogue No.

Name / Description

PN-004 514

TactiSys Quartz – Stockert RF cable

PN-004 515

TactiSys Quartz – Ampere™ RF cable

Note: The RF generator cable is required to connect the TactiSys Quartz Equipment hardware to the RF generator. An ablation procedure with the TactiCath™ Quartz Set 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.

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5.2 Setting up the system 5.2.1

TactiSys™ Quartz Equipment hardware installation

Location The TactiSys Quartz Equipment hardware should be placed outside of the sterile field in the electrophysiology laboratory. The Client should be placed outside the sterile field in the electrophysiology laboratory or in the control room. Warnings • Do not place the TactiSys Quartz Equipment hardware in the sterile field. • Do not place the TactiSys Quartz Equipment hardware near a heat source. • Do not obstruct the ventilation grid located on the bottom and the top of the TactiSys Quartz Equipment hardware case. • To avoid risk of damaging the TactiSys Quartz Equipment hardware, 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 Equipment Hardware Mount (see TactiSys Quartz Equipment Hardware Mount Assembling Instructions) and fix the mount close to the electrophysiology laboratory operation table.

2

Connect the mains adapter provided by St. Jude Medical 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 directly to Client via the Ethernet cable.

4

Connect the green connector of the appropriate RF cable to the TactiSys Quartz Equipment hardware RF cable socket, and the other connector into the RF generator.

5

Optional: Connect the analog output cable with the relevant socket on the TactiSys Quartz Equipment hardware and feed the signals into your electrophysiology laboratory system.

6

Connect an equipotential cable to the TactiSys Quartz Equipment hardware equipotential socket.

Note: An overview of all the TactiCath™ Quartz Set interconnections can be found in Appendix A: Interconnections of the TactiCath™ Quartz Set. Warning • Use only the mains adapter provided by St. Jude Medical to supply the TactiSys Quartz Equipment hardware (see Appendix B: List of accessories). • 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).

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• No modification of this equipment is allowed. Caution 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.

5.2.2

TactiSoft™ software installation The TactiSoft software must run on a dedicated personal computer which fulfills St. Jude Medical’s required performance specifications listed in section 9.4.3. The dedicated personal computer will be delivered with the most recent version of TactiSoft software already installed. No other software such as antivirus software or firewall software shall be installed on the dedicated personal computer used for the TactiSoft software.

Warnings • A potential reinstallation of the TactiSoft software on the dedicated personal computer shall only be performed by St. Jude Medical qualified personnel or by maintenance personnel accredited by St. Jude Medical.

• The personal computer hosting TactiSoft software shall be dedicated to running the TactiSoft software and to the display of the force signals. In order to guarantee that TactiSoft software will operate with the required performance, no additional software application or antivirus scan shall be installed and run during the procedure, nor shall the computer be connected to remote Internet host sites during the procedure. A physically private network shall be created to avoid viruses or the like to get in the system.

• TactiSoft software requires a minimum of 5 GB free hard drive space in order to run. Avoid storing large amount of data on the Hard Disk other than data generated by TactiSoft software.

• Compliance with the requirements for performance and configuration of the personal computer hosting TactiSoft software is mandatory for the safe use of the TactiSys™ Quartz Equipment.

5.2.3

TactiSoft™ software license A license is required to identify the relevant TactiSys™ Quartz Equipment hardware on the computer running TactiSoft software. It is customized for your TactiSys Quartz Equipment hardware and will not work with other TactiSys Quartz Equipment hardware. In case of technical problems, please contact your local representative.

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5.3 Instructions and performance tests at operating site Check correct functioning The following table shows how you can test whether the device is working properly: When you…

Then…

Press the TactiSys™ Quartz Equipment hardware power ON/OFF switch (turn on)

The TactiSys Quartz Equipment hardware starts. The initialization sequence may take up to 2 minutes.

Switch ON the personal computer hosting the TactiSoft™ software

The personal computer starts; wait until startup tasks are completed. • The TactiSoft software starts. • The welcome screen appears (please refer to section 6.4.1). • A message notifying the user of a successful network connection with the TactiSys Quartz Equipment hardware is displayed on the screen for 3 seconds.

Connect a TactiCath™ Quartz demo catheter and press the button “Procedure” on the welcome screen

•

Apply force on the catheter tip

•

Press the button “End Procedure” on the procedure screen and click on “OK” to confirm end of procedure.

• •

The procedure stops. The welcome screen appears.

Press the button “Exit” on the welcome screen

•

TactiSoft software exits.

Double click on shortcut “Shutdown PC” on the personal computer desktop

•

The personal computer shuts down.

Press the TactiSys Quartz Equipment hardware power ON/OFF switch (turn off)

•

•

TactiSoft software initializes and the procedure screen appears. No error message appears. Force information appears on the procedure screen (please refer to section 6.4.2 for a more detailed explanation)

The TactiSys Quartz Equipment hardware shuts down.

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5.4 Cleaning and disinfecting the system Instructions To avoid complications due to contamination of the system components (TactiSys™ Quartz Equipment hardware, TactiSys™ Quartz Equipment Mount, cables), clean and decontaminate them before and after use. The following table shows how to clean and disinfect the system components: Do …

Do not …

•

•

• • •

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.

• •

Use flammable and explosive agents to clean and disinfect the devices. Use acetone-containing agents to clean the devices. Use sterilization methods (e.g., gas, steam, hot air).

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

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6. TactiSys™ Quartz Equipment Components 6.1 Important information Warnings • Except for the mains connection, do not plug cables or leads directly into a power supply. Such action may result in patient electrocution.

• To avoid the risk of explosion, the TactiSys™ Quartz Equipment hardware must not be used in rooms with flammable anesthesia.

• The patient should not come into contact with metal parts that are grounded or have considerable ground capacity (e. g. operating table, supports etc.) For this purpose, we recommend the use of antistatic drapes.

• 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.

• To avoid system malfunction and to maintain safety, 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.

• Only mains adapter, cables and other accessories provided by St. Jude Medical shall be used.

• In patients with cardiac pacemakers or pacemaker leads, there is a risk of interference with pacemaker function or damage to the pacemaker during ablation procedures. In case of doubt, consult the cardiology department.

• Do not spill liquid on TactiSys Quartz Equipment hardware components. Cautions • 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 TactiCath™ Quartz Contact Force Ablation Catheter that you intend to use with TactiSys Quartz Equipment hardware.

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6.2 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 ...

Client

An Ethernet cable

RF Generator (60)

An electrical interface cable connected to the rear panel (42)

TactiCath™ Quartz Catheter

The connection cable (1) of the TactiCath Quartz Catheter, consisting of one electrical connector (5) and one optical connector (6)

(sold separately)

External analog voltage recorder (e.g. ECG System) (70)

An analog output cable (41) (optional)

Note: See Appendix A: Interconnections of the TactiCath™ Quartz Set 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.

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