tactisys™ quartz equipment user manual/media/manuals/product-manual... · 2016-03-17 · quartz...

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ARTEN100122632 B 2016-03

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ARTEN100122632 B TactiSys™ Quartz Equipment User Manual 1

TactiSys™ Quartz Equipment User Manual

U.S. Edition

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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).

2 ARTEN100122632 B TactiSys™ Quartz Equipment User Manual

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


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


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.


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.


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


• 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.


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).


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.


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


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


Serial Number

Lot Number

Integration Module

RF Cable

For Use With

Analog Output Cable

Transport Case

CE Mark

0086

Notified body CE mark

Pack

Adapter

Software

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


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 Mains adapter 4 a Mains cord 1 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.


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).


• 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.


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

• TactiSoft software initializes and the procedure screen appears.

• No error message appears.

Apply force on the catheter tip • Force information appears on the procedure screen (please refer to section 6.4.2 for a more detailed explanation)

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)

• The TactiSys Quartz Equipment hardware shuts down.


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.


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.


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

(sold separately)

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

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.


TactiSys™ Quartz Equipment hardware front panel

Item number Part Function 10 Reset Button To reset the force values to baseline

(see section 7.5.2)

11 Power indicator Lit when the TactiSys Quartz Equipment hardware is powered

12 Electrical socket for TactiCath™ Quartz Catheter

Accepts TactiCath Quartz Catheter electrical connector

13 Optical socket for

TactiCath Quartz Catheter

Accepts TactiCath Quartz Catheter optical connector


TactiSys™ Quartz Equipment hardware rear panel

Item Number Part Function 20 ON/OFF switch Switch on/off TactiSys Quartz

Equipment hardware

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

22 Ethernet socket Connection to Client

23 Analog output socket (optional)

Electrical connection to an external analog voltage recorder (e. g. ECG System)

24 USB port Accept mass storage device

25 RF cable socket Connection to the “catheter” connector of the RF generator

26 and 27 Serial ports For future use

28 Equipotential socket For equalization of the ground potential


6.3 Personal computer hosting TactiSoft™ Software

A dedicated personal computer with screen is necessary to run the TactiSoft software and display the information provided by the TactiSys™ Quartz Equipment hardware. Please refer to section 9.4.3 for detailed computer requirements.

6.4 User Interface: TactiSoft™ Software

The TactiSoft software graphic user interface shows the measurements of the contact force sensor in the TactiCath™ Quartz Catheter.

6.4.1 Welcome Screen

The welcome screen is the screen displayed when the TactiSoft software is started. The user can then choose between following options using a mouse:

Choose… Description Procedure Perform a procedure with a TactiCath Quartz Catheter

This process is described in the section 6.4.2 Settings Set up or modify the screen shown during a procedure

This process is described in the section 6.4.3 Library Access and download procedure reports

This process is described in the section 6.4.4 Technical Services Set up the system or modify system settings

This process is described in the section 6.4.5 Preset scroll-down menu

The user can choose a custom user profile (or the default parameters) to configure the procedure screen display

Exit Exit the TactiSoft software


6.4.2 Procedure Screen

Default procedure screen By selecting “Procedure” in the welcome screen, the following screen is displayed (default). In the default mode, only the basic contact force display features are active.

Full overview

If desired, the user may customize the display screen to include the optional screen features shown below:

E

A B

C

D

F G

H

I

J K L M

N O

P


Item overview

The information provided in the procedure screen is described below:

Item Description

A Total force value

Lateral component force value

Axial component force value

B Stability indicator

Average Contact Force

Constant Contact

Stable Contact Force

C Lesion Index

D Force-Time Integral

E Information field

F Force history: graph of the force exercised during the preceding 15 seconds (rolling)

G Force scale indicating color change thresholds

H Mean force indicator

I Indicator of RF application (vertical red lines)

J Graphical representation of the total force and the localization contact (ball)

K System clock

L End procedure button

M Settings button

N Capture button

O Reset button

P Average force during ablation


A. Force values

Overview The force values on the procedure screen show the total force, as well as its lateral and axial components as measured by the catheter. All force values are expressed in grams (g).

Illustration of forces The following diagram illustrates the method used to calculate and display contact forces on the user interface:

Graphical representation The total force is displayed as a green ball in the graphical force representation as shown in Section J Graphical representation of Force.

Caution A faulty connection may result in no force information displayed. The procedure may be continued after cleaning the optical connector, or continued without force information as is commonly performed with standard RF ablation catheters.

B. Stability indicator

The stability indicator is an optional feature that summarizes the catheter stability to the user. If activated in Settings, it is displayed continuously when a TactiCath™ Quartz Catheter is connected.

Three independent parameters assess average force, constant contact and stable force. Each parameter is calculated based on most recent contact force history and can be activated individually or in combination. If an element has not been selected it remains invisible to the user.

The indicator displays green when user-defined conditions are met and amber when not. The sensitivity of each parameter can be adjusted in Settings (see section 6.4.3).


A general example with all parameters activated is shown in the following screen:

Average Contact Force

The parameter Average Contact Force provides feedback on the trend of total contact force. The parameter will be:

• Green when the average contact force is above the threshold defined by the user in Settings (see section 6.4.3).

• Amber when the contact force is below the aforementioned threshold.

Constant Contact

The parameter Constant Contact provides feedback on the degree of intermittent contact. The parameter will be:

• Green when the force is generally constant (total force is maintained above a user-defined value), with little or no intermittent contact.

• Amber when intermittent contact causes longer periods with little or no force.

Stable Contact Force

The parameter Stable Contact Force provides feedback on the degree of contact force variation over time. This parameter will be:

• Green when force variation (user-defined, in grams) over the prescribed number of seconds (also user-defined) is low (e.g. stable catheter position with or without respiration impact).

• Amber when contact force variation exceeds the user defined thresholds in Settings (e.g. catheter loses contact suddenly or there is a significant force variation due to respiration).


C. LSI™

The LSI™ (Lesion Index) is a proprietary index combining contact force, radiofrequency (RF) application duration, and RF current. This parameter was displayed during ablation procedures in a 31-patient supplemental study to the TOCCASTAR clinical trial. However, the clinical utility of this parameter has not been evaluated.

The calculation of the LSI is automatically triggered when ablation current is detected.

The LSI field will display a progression of blue dots for the first six seconds. After six seconds have elapsed, a numerical value will appear.

LSI is displayed by default on the procedure screen and can be deactivated in Settings (see section 6.4.3).

D. FTI™

The FTI on the procedure screen shows the real-time value of the Force-Time Integral (FTI). The calculation of the FTI is automatically triggered when ablation current is detected, and indicates the value of force integrated over ablation time, expressed in units of gram seconds (gs).

FTI is displayed by default on the procedure screen and can be deactivated in Settings (see section 6.4.3).

E. Information field

This field is dedicated to the display of informative messages during the use of TactiCath™ Quartz Set.

F. Force history

The force history on the procedure screen is a graphical representation of the total contact force over the last 15 seconds (default value).

The scale of the force history can be adjusted by the user in Settings (see section 6.4.3).

Note: Force is displayed at a high frequency and resolution which may result in transient peaks of contact force appearing on the force history graph. Very short duration force peaks may not be harmful and should be interpreted in the context of the total and average force displays.


G. Force scale indicating color change thresholds

The force scale uses color to indicate user-defined range of desired total contact force. The display may be customized in Settings to accommodate patient specific variations that are normally encountered during the procedure.

By default, the color change is OFF and the force scale is green. If color change is selected ON, the force scale is green inside the threshold and amber outside.

H. Mean force indicator

The white bar on the left of the history graph represents the average total force value. The averaging time is selected in Settings, and ranges from 1 to 15s.

I. Indicator of RF application

The application of RF during ablation is detected automatically and indicated by vertical red lines under the white curve in the “Force history” window.

The value of LSI™ or FTI™ will be calculated during the application of RF.

J. Graphical representation of Force

Illustration The following illustration shows the components of graphical force representation:

Item overview

Item Description

Q Ball

R Inner, outer concentric circles

S Blue arrow

R

Q S

Outer

Inner


Ball Meaning

The ball (Q) represents the force applied on the catheter tip.

Ball size The size of the ball represents the total force magnitude.

Ball color The color of the ball changes depending on the color change thresholds selected in Settings.

The ball is green between the upper and lower thresholds, and amber outside these thresholds.

Concentric circles Interpretation

The following table explains which angle the circles represent:

If the ball is ... Then the angle α is ...

In the center 90 °

On the inner circle 60 °

On the outer circle 0 °

In between two of the above positions A value between the angles indicated by these positions

Note: The angle α (alpha) approximates the angle between axial catheter direction and cardiac tissue surface based on the cross product of axial and lateral force components.

Illustration angle α (alpha):


Blue arrow Meaning

The blue arrow (S) below the graphical force representation determines the 0° reference for the angle θ. The angle value increases in the clockwise direction.

What is the angle θ? The angle θ represents the direction of the lateral force on the catheter with respect to its steering plane.

Examples: • An angle of 180° means that the force is on the steering axis and will tend to

decrease the steering radius, e.g. increase deflection (deflect). • An angle of 0° will tend to increase the steering radius, e. g. decrease

deflection (straighten). Illustration angle θ (theta):

Determining the angle θ

It is possible to determine the angle θ by looking at the marks on the outer circle. The marks represent steps of 5 degrees.

K. System clock

The system clock indicates the time as registered on the personal computer on which the TactiSoft™ software is operated.

The user can adjust the system time in Settings (see section 6.4.3) that is selectable from the welcome screen.

L. End Procedure

The “End Procedure” button on the procedure screen is the button pressed when the procedure is completed, or when the user wants to stop the recording and display of the contact force.

When the “End Procedure” button is pressed and the termination of the procedure is confirmed, a summary of the completed procedure is displayed, containing the general information and statistics of the ablations performed.

Note: • If no ablation has been performed, no procedure report will be displayed at

the end of the procedure.


• The procedure report will nevertheless be saved in TactiSys™ Quartz Equipment hardware memory and can be accessed from the Library (section 6.4.4).

M. Settings

By pressing the “Settings” button, the user accesses the settings screen. See section 6.4.3.

N. Capture button

By pressing the “Capture” button, a screenshot of the currently displayed screen can be saved.

O. Reset button

The “Reset” button has two functions depending on the system status. Pressing the “Reset” button, during RF application resets the FTI™ and LSI™ values to zero (see section 7.5.3). When pressed at other times, the total force display is reset to zero (see section 7.5.2).

P. Average force during ablation

The red bar on the right of the total force history graph represents the average force during the ablation only. The red bar returns to zero 5 seconds after the end of the last ablation.

6.4.3 Settings Screen

A. General settings

Settings may be accessed by selecting “Settings” in the welcome screen (or, from the procedure screen). The ‘General’ tab with “Screen” option selected is initially displayed:


The choices available for the “Screen” option are described in the following table:

Choose… Description Options (default value underlined)

Show lateral/axial force

Display/hide force components None Axial Lateral Both

Display LSI / FTI

Display/hide Lesion Index or Force-Time Integral value during ablation

LSI™ FTI™ Both None

Scale force axis Change scale of the force axis 100 g Range 30 g to 150 g

Scale time axis Change scale of the time axis 15 s Range 10 s to 30 s

Averaging time Time over which the average force is calculated

5 s Range 1 s to 15 s

Color change Function changes the color of the graphical force representation (“ball”) and the force scale depending on the force

OFF ON

Upper threshold If Color change selected, upper threshold for color change

SELECT None Range 30 g to 150 g

Lower threshold If Color change selected, lower threshold for color change

SELECT None Range 5 g to 30 g

By selecting the “Stability Indicator” option the following screen is displayed:


Note: When the stability indicator is first switched ON in Settings, the operational parameters must be configured before the stability indicator may be used.

The choices available for the “Stability Indicator” option are described in the following table:

Choose… Description Options (default value underlined)

Show stability indicator

Display/hide the selected parameters of the Stability Indicator

ON OFF

Average Force: Force threshold

Minimum average force to be considered as acceptable

SELECT OFF Range 5 g to 20 g

Constant Contact: Force threshold

Minimum force to be considered for contact versus no contact

SELECT OFF Range 1 g to 5 g

Stability Calculation period

Time interval over which the stability of the force is analyzed

SELECT OFF Range 1 s to 5 s

Stability Force variability

Maximum force variation to be considered stable

SELECT OFF Range 2.5 g to 15 g


B. User Profile settings

By selecting “User Profile” in the settings screen, the following screen is displayed.

This screen allows the creation of a new user profile. The user can select a custom set of parameters used to configure the procedure screen.

Create New User Profile This button enables creation of new user profile by replicating the default values for settings and customizing them. The user is required to provide a unique name (other than “Default”) to save the new profile.

Rename User Profile This button allows the user to rename their existing settings with the limitations above.

Delete User Profile This button allows the user to delete the existing user settings except the default settings.


C. System settings

By selecting “System” in the settings screen, the following screen is displayed.

Setting of Date (Year – Month – Day) and Time (Hour – Minute)

These parameters are set by increasing/decreasing the field value using the arrows next to the fields. These parameters are recorded in the system when the user clicks the “OK” button.

This setting takes effect immediately.

Setting of Language This parameter is set with a scroll down menu, the different languages available are: English, French, German, Spanish, and Italian.

This setting takes effect only when the “OK” button is pressed.

Setting of Ablation Detection Threshold This parameter sets the threshold at which the ablation current is detected. “Low” is selected by default and works for most RF generators. In case ablation current is detected when not ablating, select the “High” value in the scroll down menu.

6.4.4 Library Screen

By selecting “Library” in the welcome screen, the following screen is displayed.

This library allows the user to save and review past procedure reports recorded by TactiSys™ Quartz Equipment hardware.


Search Criteria Procedure reports from the preceding 7 days are displayed by default.

To find prior specific procedure report(s), the date(s) of the saved procedure(s) must be entered as Search Criteria.

Dates can be modified by increasing/decreasing each of the day, month and year fields, or by choosing the date directly from the calendar. To show the calendar pop-up, click on the calendar icon to the right of each date.

Search Results By clicking the “Search” button, the Search Results list will be updated and the procedure reports from the indicated period will be displayed.

Summary On the right side of the screen, the procedure report of the very first entry in the list will be shown.

By selecting another entry, the equivalent procedure report will be shown.

The user can scroll sequentially through the procedure reports appearing in the Search Results list by clicking on the “previous” and “next” buttons.

Export functionality The user may export procedure reports from one or multiple procedures, together with the respective screenshots (if any) to a USB storage device.

For each procedure one subfolder (“ProcedureReport”) will be saved containing both an image and an HTML version of the procedure report, as well as a text file containing detailed information. Another subfolder (“ScreenCaptures”) contains the screenshots.

How to export procedure reports? The user can manually select the procedures to be exported, or select the entire list by clicking on “select all”.


A USB storage device must to be inserted into one of the USB ports on the rear panel of the TactiSys™ Quartz Equipment hardware. After clicking on “Save to USB”, the following screen will appear unless a USB storage device is connected and recognized.

The system will automatically detect if a valid USB storage device is connected and prompt for confirmation to transfer the selected procedure report(s) to the USB storage device.

After successful transfer a confirmation window will appear, asking for confirmation before the USB device can be disconnected.


6.4.5 Technical Services Screen

By selecting “Technical Services” in the welcome screen, the following screen is displayed. This screen allows the user to set technical parameters in the system.

Analog Output The analog output option allows analog signal information to be sent to external diagnostic / mapping systems available in the electrophysiology laboratory.

Warning • The analog output does not communicate error messages and can therefore not

warn of inaccuracies or trigger necessary user operations.

• Do not use the analog output as sole source of force information. A Client shall be connected via Ethernet at the same time for having access to displayed error messages and force information.

Analog output parameters Two analog output channels are available and can be configured.

Note: By default both channels are disabled.

If the analog output is enabled, the following parameters can be changed in order to configure the output for use by the external diagnostic / mapping systems available in the electrophysiology laboratory.

Analog output parameters are defined by the last Client that connected.


Parameter Description Range

Total force range [g] Set total force at which maximum analog output voltage is transferred to external system

30 – 150

LSI™ Set LSI at which maximum analog output voltage is transferred to external system

0 – 10

FTI™ (gs) Set FTI at which maximum analog output voltage is transferred to external system

500 – 10000

Alpha angle (°) Set Alpha angle at which maximum analog output voltage is transferred to external system

90 (fixed)

Theta angle (°) Set Theta angle at which maximum analog output voltage is transferred to external system

360 (fixed)

Lateral force range (g)

Set lateral force at which maximum analog output voltage is transferred to external system

30 – 150

Axial force range (g) Set axial force at which maximum analog output voltage is transferred to external system

30 – 150

Ablation current (mA) Set current at which maximum analog output voltage is transferred to external system

500 – 2000

Both channels are independently configurable by the user through pull-down menus to assign a value range of the parameter selected, a voltage range and voltage that is sent when no data is available.

Parameter Description Range

Range In Units Maximum value of the relevant parameter selected

Depending on selected

parameter (see table above)

Voltage Range [mV] Maximum voltage at the analog output when relevant parameter has reached its maximum.

Minimum value is 0 V.

20-3000

No Data voltage [mV] Analog output voltage if for the selected value no information is available (e.g. due to defect). The voltage on the analog output will oscillate between this value and 0 V at a frequency of 5 Hz.

20-3000


Log Files The user has the option to retrieve log files in order to save them to a USB mass storage device. Log files include encrypted technical information that may be used by St. Jude Medical qualified personnel for maintenance or data analysis purposes.

The same process for selection of files and storage to a USB device is used for log files that is used for procedure reports from the library screen (refer to section 6.4.4).

Technical Info By selecting “Technical Info” in the technical services screen, the following screen is displayed.

The user may optionally retrieve information on the specification of installed hardware and software.

This information can be useful for maintenance or troubleshooting purposes.


Communication By selecting “Communication” in the technical services screen, the following screen is displayed.

The tab is used to view system communication related parameters and to select a license token from those installed. This screen may also be useful if you have any technical problem and need to phone support.

On this screen, the host parameters refer to the computer on which the TactiSoft software is running.

Current Communication Configuration These parameters are standard Ethernet parameters and represent the current configuration if the Client is connected to the TactiSys™ Quartz Equipment hardware. The green light indicates that there is a valid connection between the Client and the TactiSys Quartz Equipment hardware.


7. Procedures to operate TactiSys™ Quartz Equipment Note: The following instructions describe functions and screens of the procedure to operate the TactiSys Quartz™ Equipment hardware in combination with a standard personal computer hosting TactiSoft™ software. Operating the TactiSys Quartz Equipment hardware with the EnSite™ Contact Force Module is described in the EnSite™ Contact Force Module Instructions for Use.

7.1 Switching on the TactiSys™ Quartz Equipment hardware

Power on the TactiSys Quartz Equipment hardware using the ON/OFF switch located on the rear panel. When the power is turned on, the power indicator on the front panel will become green and the TactiSys Quartz Equipment hardware will load the configuration parameters and run initialization procedures. During this phase, the Reset button slowly flashes green with the pattern shown below, indicating that the TactiSys Quartz Equipment hardware is not ready to start a procedure yet. When the Reset button stops flashing, the TactiSys Quartz Equipment hardware is ready to connect and starts searching for an external Client to communicate with. If the TactiSys Quartz Equipment hardware is ready, but no catheter is connected, the Reset button flashes red.

System state Condition

System not ready

No catheter connected and no client connected

System ready No catheter connected and client ready

1 s

Quartz initialization Device initialization after power up

1 s 1 s 1 s

No catheter connected and no client connected

No catheter connected and client ready System ready

System not ready

Quartz initialization

Device initialization after power up

Condition System state


7.2 Starting the TactiSoft™ software

Switch on the personal computer on which the TactiSoft software is installed. The TactiSoft software starts and the welcome screen appears (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.

Note: Switching on the TactiSys Quartz Equipment hardware and launching the TactiSoft software can be performed in any order.

Caution Make sure that the system functions properly before procedure.

Warning Ensure that no other program is running at the same time on the personal computer in order to avoid compromising the performance of the TactiSoft software.

7.3 Connecting a TactiCath™ Quartz Catheter

1 Unpack the TactiCath Quartz Catheter and place it in a sterile work area.

2 Connect the catheter’s electrical connector to the TactiSys Quartz Equipment hardware electrical socket. Remove the optical connector protection cap and connect the catheter’s optical connector to the optical socket.

Caution: Carefully align the optical connector with the TactiSys Quartz Equipment hardware optical socket while firmly pushing in order to ensure safe connection.

Warning: Make sure that the sterile catheter and connectors of the cable are completely dry and that the catheters and TactiSys Quartz Equipment hardware components are at room temperature before use.

3 Connect the irrigation tube to the Luer connector on the tube coming from the irrigation pump according to the instructions of the irrigation pump manufacturer. Purge the catheter as explained in the catheter’s IFU.


4 Make sure that the irrigation flow throughout the entire procedure is set to at least 2 ccm (ml/min) to prevent clotting or coagulum formation at the tip.

5 TactiSys™ Quartz Equipment hardware will recognize the TactiCath™ Quartz Catheter and preloads calibration data into the TactiSoft™ software.

6 Insert the catheter via a vascular access port (Please refer to the catheter’s IFU).

7 When the catheter is connected and recognized, the Reset button is green.

7.4 Starting a TactiCath™ Quartz Catheter procedure

1 If user profiles have been defined, selected the desired profile before starting the procedure. In case no user profiles are defined the standard “Default” profile is automatically applied.

Caution: Verify the selected user profile on the settings screen before beginning procedure.

2 By clicking on the button “Procedure” on the welcome screen, TactiSoft software initializes and the procedure screen appears.

3 If not already done, connect a new TactiCath Quartz Catheter as described in Section 7.3.

4 Position the catheter in a free-floating (non-contact) position inside the heart and perform a reset.

Warning: A message “Please reset baseline” is displayed until the reset is performed.

Caution If an invalid TactiCath Quartz Catheter is connected, one of the following messages can appear: "Catheter type not compatible with active license” or “Catheter already used (24 hours limit)”.

If a damaged TactiCath Quartz Catheter is connected, one of the following messages can appear: "No force information available” or “No catheter connected” or “Catheter memory content corrupted”.

Warning Base-line shift of the force output may occur during the procedure. Operator should verify baseline integrity periodically during use. To check for baseline shift, position the catheter tip in a free-floating position away from the heart wall. In case of significant base-line shift (e.g. >5 g), a reset to zero should be applied by pressing the Reset button on the TactiSys Quartz Equipment hardware or by clicking on the button “Reset Baseline” on the procedure screen (when not ablating) of the TactiSoft software. Refer to section 7.5.2.

7.5 Performing a TactiCath™ Quartz Catheter procedure

On the procedure screen the user has access to different options as described in section 6.4.2. Note: The force measurement is for information only and should not replace standard handling precautions.


7.5.1 Settings

During the procedure the user can access the same settings screen as described in section 6.4.3, by clicking on the button “Settings” on the procedure screen.

7.5.2 Resetting the force values to baseline

When to check for baseline contact force? Baseline operation should be checked regularly and if necessary reset to zero, especially under the following circumstances:

• After the first insertion of the catheter into the body (refer to section 1.1). • After reinsertion into the patient’s body after retraction through a sheath. • When the message “Please check baseline” is displayed.

The “Please check baseline” message appears:

− When high forces have been applied onto the force sensor (> 66 g lateral or > 200 g total force).

− When the system has detected a potential baseline shift.

This will be indicated by the Reset button flashing red with the following pattern:

How to reset the force values?

Bring the catheter to a non-contact position. In most cases the system will automatically correct the baseline.


In some cases, the reset algorithm is not able to detect appropriate circumstances to automatically adjust the baseline and a manual reset is necessary. In this case, press one of the following:

• The Reset button on the TactiSys™ Quartz Equipment hardware. • The button “Reset baseline” on the procedure screen. Note: The baseline cannot be reset during and 3 seconds after an ablation. Results of manual reset baseline:

• The TactiSys Quartz Equipment hardware produces a buzzing sound to confirm that a manual reset has been applied.

• The force displayed is reset to zero. • The message "Baseline reset applied" will be displayed for 3 seconds.

Warning

Make sure that the catheter is in a free-floating (non-contact) position before manually resetting the baseline. Contact can be identified by periodic changes (“bumps”) on the force graph or generally an uneven force graph (see example in the following screen).


Note that when the catheter is in a free-floating position, the force value will not be around zero if a baseline shift has occurred.

Resetting to zero while the catheter is in contact may cause important differences between the value shown on the screen and the actual force applied to the tissue.

7.5.3 Ablation

Ablation phases TactiSys™ Quartz Equipment hardware will automatically detect RF energy and indicate the initiation of ablation with vertical red lines under the white curve in the Force History window. When ablation energy is detected, the relevant LSI™ or FTI™ for the specific ablation will be continuously calculated and displayed.

Note: The LSI or FTI information is most relevant when a point-by-point technique is used as the value displayed is normally calculated over the entire duration of RF application. In cases where the user maintains RF application while moving the catheter to an adjacent position, resetting FTI/LSI allows for calculation of a new FTI or LSI with no RF interruption. This will record a new ablation in the statistics provided in the procedure report. Resetting FTI/LSI can be used at any time during an RF ablation (e.g. when a new catheter position is reached).

How to reset the FTI™/LSI™ value? During an ablation, press one of the following:

• The Reset button on the TactiSys Quartz Equipment hardware. • The button “Reset FTI/LSI” on the procedure screen.


Results of manual reset FTI™/LSI™:

• The TactiSys™ Quartz Equipment hardware produces a buzzing sound to confirm that a manual reset has been applied.

• FTI™, LSI™, Average force during ablation are reset to zero. • The message "FTI/LSI reset applied" will be displayed for 3 seconds.

Warning

• The operator should not rely solely on the stability indicator information during ablation (if selected in Settings)

• When ablating on the posterior wall, all information available in the electrophysiology laboratory should be taken into consideration by the operator to determine the amount of RF energy delivered in order to avoid esophageal damage. The operator should not rely solely on LSI or FTI parameters during ablation on the posterior wall.


7.5.4 Take a Screenshot

A screenshot of the actually displayed screen can be taken by clicking on the button “Capture”.

The jpg-format image files will be stored on the personal computer running the TactiSoft™ software together with the procedure report (subfolder “ScreenCaptures”).

When button is clicked the graphical symbol flashes red in order to confirm that the command was executed.


7.5.5 End procedure

After finishing a procedure and terminating the use of the catheter, please click on the button “End Procedure”. A confirmation dialog will open:

After clicking “OK”, all data will be analyzed and a procedure report will be displayed on the screen.

Note: Leaving a procedure without following the steps described above will prevent the procedure report from being generated. No procedure report will be available under Library.

Note: If no ablation was performed during the procedure, the user returns to the welcome screen.

By clicking “Cancel”, the current procedure will be continued.


7.6 Replacing a TactiCath™ Quartz Catheter

To replace the catheter currently connected to the TactiSys™ Quartz Equipment hardware, proceed as follows:

1 It is not necessary to interrupt the current procedure by clicking on the button “End procedure” to replace a catheter.

2 Unplug the catheter you wish to replace.

The message "No catheter connected" will be displayed.

3 Plug in a new catheter and perform actions described in sections 1.1 and 1.1.

Caution If no valid catheter is connected, a message describing the reason for this invalidity will appear and the Reset button is red.

Note: Data collection for inclusion in the procedure report will continue until the “End Procedure” button is selected. Starting a new procedure will cause the subsequent procedure data to be entered in a new report.

7.7 Downloading log files from the TactiSys™ Quartz Equipment Hardware

Log files can be retrieved from TactiSys Quartz Equipment hardware through its USB port.

Method to download all log files stored on the TactiSys Quartz Equipment hardware:

1 Introduce a USB storage device in the TactiSys Quartz Equipment hardware USB port

2 Press on the Reset button for 3 seconds or more (no Client and no catheter connected)

3 Active downloading is signaled to the user by a sound and Reset button light

4 Successful or unsuccessful completion of file download is signaled to the user by two different sound patterns and Reset button light color.

Note: log files are encrypted and are for maintenance purposes only. They contain no information accessible to the user.

Reset button light flashing scheme during log file download:


8. Error overview Screen shot

The following screenshot shows an example of an error message:

List of Errors and Information Messages The table on the following pages shows a complete list of possible error messages, their causes and solutions. The severity ranking is based on the following criteria:

Warning: information message that does not prevent the proper use of the device. The problem is fixed by the software itself.

Recoverable: the problem may be fixed by checking the cable connections or connecting a catheter with valid parameters.

Unrecoverable: the problem cannot be fixed without verification of the hardware status and / or configuration files.

Informative: the message indicates system status during normal operation.

Note: in this section the word “warning” has a meaning strictly linked to the severity of the software event occurring, and is not related to the meaning of the word “warning” as defined in section 3, which is valid over all other sections of this document.


Code Title Context Severity Resolution

7100

Several USB drives detected, please remove all but one

Library Screen: Exporting procedure reports

Technical Services: Saving log files

Warning Remove one of the USB drive

7101 No USB drive detected. Please insert a USB flash drive



Warning Insert a USB drive

7102 File transfer cancelled Library Screen: Exporting procedure reports


Informative

7103 USB drive contains these files already. Do you want to overwrite?



Warning Choose the desire action. Yes to overwrite the files and no to cancel the operation.

7104 Error connecting to USB drive, transfer cancelled



Warning Use another USB drive

7105 USB drive memory full, transfer cancelled



Warning Use another USB drive or free some space on it

7106 USB drive error, transfer cancelled



Warning Use another USB drive



7109 File transfer complete Library Screen: Exporting procedure reports


Informative

7110 Configuration file "TactiSoft_settings" not found

Starting the TactiSoft™ software

Unrecoverable Call Technical support

7111 Configured language file not found, english will be used instead

Starting the TactiSoft software

Warning Call Technical support

7112 No catheter connected Procedure Warning Plug in a catheter if not present or unplug and re-plug the catheter or use a new catheter

7113 Undefined error received from TactiSys Quartz Equipment hardware

Communication with TactiSys™ Quartz Equipment hardware

Unrecoverable Restart the TactiSys Quartz Equipment hardware

Call Technical support

7114 Catheter already used (24 hours limit)

Procedure Warning Use a new catheter

7115 Catheter incompatible (Type not compatible with TactiSys Quartz Equipment hardware)

Procedure Warning Use a compatible catheter.


7116 No force information available

Procedure Warning Check optical connection or use a new catheter.

7117 No fiber optic signal or out of range

Procedure Recoverable Check optical connection or use a new catheter.


7118 No thermocouple signal or out of range

Procedure Recoverable Check electrical connection or use a new catheter.


7119 No thermistor signal or out of range

Procedure Recoverable Check electrical connection or use a new catheter.




7120 Ablation current out of range

Procedure Recoverable Check the Generator.


7121 Catheter memory content corrupted

Procedure Unrecoverable Check electrical connection. Use a new catheter.


7123 Quartz Internal Error: PCB communcation error

Procedure Recoverable If persistent, restart the TactiSys™ Quartz Equipment hardware


7124 Quartz Internal Error: PCB Internal Error

Procedure Recoverable If persistent, restart the TactiSys Quartz Equipment hardware


7125 Quartz Internal Error: Decreased performance

Procedure Recoverable If persistent, restart the TactiSys Quartz Equipment hardware


7126 Quartz Internal Error: Initialization failed

Procedure Recoverable Restart the TactiSys Quartz Equipment hardware


7127 TactiSys Quartz Equipment hardware not ready

Procedure Informative Wait until the TactiSys Quartz Equipment hardware’s status light is green or flashing red.


7128 Catheter type not compatible with active license

Procedure Warning Use a compatible catheter.


7129 Unauthorized command Communication with the TactiSys™ Quartz Equipment hardware

Recoverable If persistent, restart the TactiSys Quartz Equipment hardware


7133 ...cleaning up old log files Starting the TactiSoft software

Informative



7134 ...Done cleaning up old log files


Informative

7135 Default settings cannot be renamed or deleted

Settings Informative

7136 Default language file not found, please contact technical support



7137 Desired language file not available, operation cancelled

Settings Warning Call Technical support

7138 Error creating measurement log file

Procedure Unrecoverable Call Technical support

7139 Unable to configure Analog Output!


Technical Services: Analog Output


7140 Unable to configure Ablation Detection Threshold!

Starting TactiSoft

Settings: System


7141 The device calibration will expire in x days. Device cannot be used after this period. Please contact Technical Service!


Warning Call Technical support within the period of x days

7142 Calibration expired! Device cannot be used. Immediately contact Technical Service!



7143 The current TactiSoft software version vX.x.x.x is not compatible with the connected TactiSys Quartz Equipment hardware (vX.x.x.x/API vX.x.x). Please contact technical service!





7201 Invalid License - Connection refused

Opening communication with the TactiSys™ Quartz Equipment hardware

Unrecoverable Select appropriate license.


7203 Communication with TactiSys Quartz Equipment hardware established

Opening communication with the TactiSys Quartz Equipment hardware

Informative

7204 Communication error with TactiSys Quartz Equipment hardware

Procedure Recoverable Check Ethernet Cables

Check communication setup in the Technical Services


7206 Unable to communicate with TactiSys Quartz Equipment hardware




7207 TCP communication connection request timeout




7208 License validated - Connection accepted


Informative

7209 License not valid on this computer - Connection refused




7210 TactiSys Quartz Equipment hardware not ready - Please wait...


Informative If persistent, call technical support

7211 Undefined code - Connection refused





7212 Maximal number of Client reached - Connection refused

Opening communication with the TactiSys™ Quartz Equipment hardware

Recoverable Exit all TactiSoft™ software instances, and restart TactiSoft software.

Restart the TactiSys Quartz Equipment hardware.


7213 License expired (time limited license) - Connection refused



7214 Received data not synchronized

Procedure Recoverable If persistent, check Ethernet connection and close any other software running on the personal computer hosting the TactiSoft software.


7215 No connection with TactiSys Quartz Equipment hardware. Please wait, attempting connection...

Procedure Recoverable If persistent, check Ethernet cables.


7216 License file not found, please select another license




7217 Selected license is incomplete, please select another license


Warning Select appropriate license.



9. Technical specifications

9.1 Technical safety inspections

List of inspections To ensure device safety, maintenance, repairs and technical safety inspections must only be performed by St. Jude Medical or an agent which has been expressively authorized by St. Jude Medical.

9.2 Repairs

Repairs of the TactiSys™ Quartz Equipment and its accessories must only be performed by the manufacturer.

Repairs must be entered into the device log.

9.3 Maintenance

9.3.1 Maintaining the system

Hardware maintenance Yearly maintenance shall be performed by St. Jude Medical qualified personnel or by maintenance personnel accredited by St. Jude Medical. This maintenance shall include cleaning of the optical connector and verification of the optical unit calibration. This verification of calibration needs to be performed at least once a year. A relevant message will be displayed upon startup when approaching the expiration date (60, 45, 30, 15 days as well as every day beginning 5 days before expiration).

Caution: Upon expiration, the system cannot be used until the yearly calibration has been performed.

You should never perform hardware maintenance other than cleaning and disinfecting the system (see section 5.4), except the routine maintenance described below. If any hardware problem occurs, contact St. Jude Medical.

The TactiSys™ Quartz Equipment hardware contains a lithium battery for keeping the date and time in the embedded PC-board. There is a danger of battery explosion if it is incorrectly installed. Do not attempt to recharge, force open, or heat the battery. In case the date and time are lost, please contact St. Jude Medical for battery replacement.

Routine maintenance The routine maintenance should be performed monthly according to the following procedure:

– Clean and disinfect the system. Please refer to section 5.4 for cleaning and disinfecting instructions.

– Inspect carefully the mains cord for any signs of mechanical damage to cable or connector. If damaged, replace with a genuine St. Jude Medical replacement part. Do not attempt to repair.


– Inspect any other electrical or optical cable assembly for any signs of mechanical damage to cable or connector. If damaged, replace with a genuine St. Jude Medical replacement part. Do not attempt to repair.

– Inspect the TactiSys™ Quartz Equipment hardware plastic cover for any signs of mechanical damage, such as cracks or holes. If damaged, contact your vendor technical support as soon as possible. Do not attempt to repair.

Warning: Electrical shock hazard: The TactiSys Quartz Equipment hardware must be switched off and disconnected from the mains power supply 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.

Software maintenance The software maintenance is performed by St. Jude Medical qualified personnel or by maintenance personnel accredited by St. Jude Medical.

9.3.2 Maintenance contract

If desired, a maintenance contract can be arranged with the manufacturer. This maintenance contract will include inspection of technical safety.

9.4 TactiSys™ Quartz Equipment Hardware Specifications

9.4.1 General

Mains Adapter (provided by St. Jude Medical) Input Voltage: 100 – 240 VAC Input Frequency: 50 – 60 Hz Input Current: 1.1A Output Voltage: 12V VDC Output Current: 3.8 A

TactiSys Quartz Equipment Hardware Power supply (from mains adapter) Input voltage: 12 V Input current: 1.5 A

Protection Protection against electrical shock: Class II Applied part (TactiCath™ Quartz Catheter): CF, protected against the effects of defibrillation Degree of protection against ingress of solids and water: IP20

Electromagnetic compatibility (EMC) The equipment complies with IEC 60601-1-2 (2007) and the relevant particular standards for emission and immunity, see Appendix C: Electromagnetic compatibility.

Physical Specifications TactiSys™ Quartz Equipment hardware:

- Height: 235 mm - Width: 260 mm - Depth: 185 mm - Weight: 4.6 kg


9.4.2 System performances

F. total Total force display range: 0 to 990 g Total force display resolution: 1 g Total force accuracy during mapping: - F < 20 g: ± 3 g - 20 g ≤ F ≤ 150 g: ±15 % of F - F > 150 g: unspecified Total force offset during RF delivery: - F ≤ 150 g: ±10 g

F. lateral Lateral force display range: 0 to 990 g Lateral force display resolution: 1 g

F. axial Axial force display range: 0 to 990 g Axial force display resolution: 1 g

Analog output See Section 6.4.5 Technical Services Screen.

9.4.3 Compatibility with external devices

Warning The use of accessories and cables other than those specified may result in increased emissions or decreased immunity of this product (see Appendix C: Electromagnetic compatibility).


Minimum requirements for personal computer hosting TactiSoft™ software • CPU: - Intel Duo Core 1.86 GHz or equivalent (Windows XPSP2)

- Intel Core i3 2.27 GHz or equivalent (Windows 7) • RAM : - 1 GB (Windows XPSP2)

- 2 GB (Windows 7) • Hard Drive: 5 GB free space • Video Adapter: SVGA video resolution (1024x768) • Screen: 15 Inch capable of 1024x768 resolution with 4:5 Aspect ratio • 2 USB 2.0 port • USB standard Mouse • 10/100 Ethernet Adapter • .NET Framework:

- Version 3.5 SP1 (Windows XPSP2) - Version 4 (Windows 7)

Compatible RF Generators TactiSys™ Quartz Equipment hardware is compatible only with the following RF generators:

• Biosense Webster Stockert 70 Generator, software version 1.037 • St. Jude Medical Ampere™ Generator

Minimum RF Generator Requirements RF Power Output: Adjustable 10-50 Watts RF Output Frequency: 450-550 kHz Temperature limit: Adjustable 30-50°C Thermocouple: 1 Type T Operating Impedance Range: 50-300 Ω

9.4.4 Environmental conditions

Operating conditions Ambient air temperature: +10 to +30 °C Relative humidity: 15 to 80 % Ambient pressure: 525 to 800 mmHg (700 to 1060 hPa) Irrigation flow temperature: +15 to +25 °C

Transport and storage conditions Ambient air temperature: -10 to +50 °C Relative humidity: 15 to 95 % Ambient pressure: 375 to 800 mmHg (500 to 1060 hPa)


Appendix A: Interconnections of the TactiCath™ Quartz Set


List of connections

The item numbers correspond with the numbers in the illustration on the previous page.

Item number

Name / Description

1 TactiCath™ Quartz Catheter distal tip 2 TactiCath Quartz Catheter handle 3 TactiCath Quartz Catheter proximal connection cable 4 TactiCath Quartz Catheter irrigation Luer 5 TactiCath Quartz Catheter electrical connector 6 TactiCath Quartz Catheter optical connector 10 Reset button 11 Power indicator 12 Electrical socket for the TactiCath Quartz Catheter 13 Optical socket for the TactiCath Quartz Catheter 20 ON/OFF switch 21 Power socket 22 Ethernet socket 23 Analog out socket (optional) 24 USB port 25 RF cable socket 26 and 27 Serial ports 28 Equipotential socket 30 Ethernet cable connector 31 Mains adapter connector 32 Analog output connector 33 RF cable connector 34 TactiSys™ Quartz Equipment Hardware Mount 40 Mains cord 41 Mains adapter 42 Analog output cable 43 RF cable 44 Ethernet cable 50 Dedicated personal computer with screen to run TactiSoft™ software 60 RF Generator 61 RF Generator Catheter socket 70 ECG system (electrophysiology laboratory system) 80 Irrigation Pump 81 Irrigation Tube


Appendix B: List of accessories Compatible TactiCath™ Quartz Catheter:

For the list of all TactiCath Quartz Catheter models compatible with the TactiSys™ Quartz Equipment Hardware, please refer to the appropriate TactiCath Quartz Catheter’s IFU.

Optional accessories of TactiSys™ Quartz Equipment and their relevant catalogue number:

Catalogue No. Name / Description

PN-004 514 TactiSys™ Quartz Equipment Hardware RF cable – Stockert Generator

PN-004 515 TactiSys Quartz Equipment Hardware RF cable – Ampere™ Generator

PN-004 510 Ethernet cable 20 m

PN-004 516 Ethernet cable 10 m

PN-001 427 Analog output cable

PN-004 511 TactiSys™ Quartz Equipment Hardware Mount

PN-004 487 VGA cable 20m


Appendix C: Electromagnetic compatibility

Electromagnetic emissions

The TactiCath™ Quartz Set is intended for use in the electromagnetic environment specified below. The customer or the user of the TactiCath Quartz Set should assure that it is used in such an environment.

Emissions test Compliance Electromagnetic environment – guidance

RF emissions

CISPR 11

Group 1 The TactiCath Quartz Set uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

RF emissions

CISPR 11

Class A The TactiCath Quartz Set is suitable for use in all establishments other than domestic, and may be used in domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes, provided the following warning is heeded:

Warning: This equipment/system is intended for use by healthcare professionals only. This equipment/ system may cause radio interference or may disrupt the operation of nearby equipment. It may be necessary to take mitigation measures, such as re-orienting or relocating the TactiCath Quartz Set or shielding the location.

Harmonic emissions

IEC 61000-3-2

Class A

Voltage fluctuations/

Flicker emissions

IEC 61000-3-3

Complies

Electromagnetic immunity

The TactiCath Quartz Set is intended for use in the electromagnetic environment specified below. The customer or the user of the TactiCath Quartz Set should assure that it is used in such an environment.


Immunity test IEC 60601 test level

Compliance level Electromagnetic environment - guidance

Electrostatic discharge (ESD)

IEC 61000-4-2

±6 kV contact

±8 kV air

±6 kV contact

±8 kV air

Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30 %.

Electrical fast transient/burst

IEC 61000-4-4

±2 kV for power supply lines

±1 kV for input / output lines

±2 kV for power supply lines

±1 kV for input / output lines

Mains power quality should be that of a typical commercial or hospital environment.

Surge

IEC 61000-4-5

±1 kV differential mode

±2 kV common mode

±1 kV differential mode

±2 kV common mode

Mains power quality should be that of a typical commercial or hospital environment.

Voltage dips, short interruptions and voltage variations on power supply input lines

IEC 61000-4-11

<5 % UT

(>95 % dip in UT) for 0,5 cycle

40 % UT

(60 % dip in UT) for 5 cycles

70 % UT


<5 % UT

(>95 % dip in UT) for 5 sec

<5 % UT

(>95 % dip in UT) for 0,5 cycle

40 % UT


70 % UT


<5 % UT

(>95 % dip in UT) for 5 sec

Mains power quality should be that of a typical commercial or hospital environment. If the user of the TactiCath™ Quartz Set requires continued operation during power mains interruptions, it is recommended that the TactiCath Quartz Set be powered from an uninterruptible power supply or a battery.

Power frequency (50/60 Hz) magnetic field

IEC 61000-4-8

3 A/m 3 A/m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

Note: UT is the AC mains voltage prior to application of the test level.


RF portable equipment

The TactiCath™ Quartz Set is intended for use in the electromagnetic environment specified below. The customer or the user of the TactiCath Quartz Set should assure that it is used in such an environment.

Immunity test IEC 60601 test level

Compliance level

Electromagnetic environment – guidance

Portable and mobile RF communications equipment should be used no closer to any part of the TactiCath Quartz Set, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

Recommended separation distance

Conducted RF 3 Vrms 3 Vrms d = 1.2 √P

IEC 61000-4-6

150 kHz to

80 MHz

Radiated RF 3 V/m

3 V/m

d = 1.2 √P (80 MHz to 800 MHz)

IEC 61000-4-3 80 MHz to

2,5 GHz

d = 2.3 √P (800 MHz to 2,5 GHz)

P is the maximum output power rating of the transmitter in Watts (W) according to the transmitter manufacturer and d is the recommended separation distance in Metres (m).

Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey,a should be less than the compliance level in each frequency range.b

Interference may occur in the vicinity of equipment marked with the following symbol:

Note 1: At 80 MHz and 800 MHz, the higher frequency range applies.

Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. a. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the TactiCath Quartz Set is used exceeds the applicable RF compliance level above, the TactiCath Quartz Set should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the TactiCath Quartz Set. b. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.


Recommended separation distances

The TactiCath™ Quartz Set is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the TactiCath Quartz Set can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the TactiCath Quartz Set as recommended below, according to the maximum output power of the communications equipment.

Rated maximum output power of transmitter

Separation distance according to frequency of transmitter

150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2,5 GHz

W d = 1.2 √P d = 1.2 √P d = 2.3 √P

0.01 0.12 m 0.12 m 0.23 m

0.1 0.38 m 0.38 m 0.73 m

1 1.2 m 1.2 m 2.3 m

10 3.8 m 3.8 m 7.3 m

100 12 m 12 m 23 m

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in Watts (W) according to the transmitter manufacturer.

Note 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.


tactisys™ quartz equipment user manual/media/manuals/product-manual... · 2016-03-17 · quartz...

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