St. Jude Medical TactiSys Quartz Equipment User manual

TactiSys
™
Quartz Equipment
User Manual
Model PN-004 400
INSTRUCTIONS FOR USE
U.S. EDITION
© Copyright 2018
St. Jude Medical
Unless otherwise noted, ™ indicates that the name
is a trademark of, or licensed to, St. Jude Medical or
one of its subsidiaries. ST. JUDE MEDICAL and
the nine-squares symbol are trademarks and
services marks of St. Jude Medical, LLC and its
related companies. © 2018 St. Jude Medical, LLC
All Rights Reserved.
ARTEN600027149B
2018-10
U.S.
Edi-
tion
St. Jude Medical
One St. Jude Medical Drive
St. Paul, MN
55117-9913 USA
[phone]
[phone]
sjm.com
Pat. http://patents.sjm.com

TactiSys™ Quartz Equipment Instructions for Use
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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 accessories. The TactiSys Quartz Equipment hardware and accessories are indicated for
use in conjunction with a TactiCath™ Contact Force Ablation Catheter. General knowledge of cardiac ablation procedures and an
understanding of the features and functions of the TactiSys Quartz Equipment hardware are a prerequisite for proper use.
CAUTION: Do not operate the TactiSys Quartz Equipment hardware without having completely read and understood these
instructions.
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 + CORR. 1:2006 + CORR. 2:2007 + A1+2012
IEC 60601-1-2:2014
IEC 60601-2-2:2009 + C1:2014

TactiSys™ Quartz Equipment Instructions for Use
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Table of Contents
Table of Contents 1
Introduction 3
System Description 3
What Is It? 3
TactiSys™ Quartz Equipment Hardware 3
Compatible Catheter 3
Related Components 3
Main Functionalities 4
System Interconnections and List of Accessories 4
Indications for Use 5
Important Safety Information 5
Physician Training 5
Safety Precautions 5
Electromagnetic Compatibility 6
Disposal 6
Symbols 6
Installation 11
Receiving, Inspecting, and Returning the System 11
Check for Completeness 11
Damage Check and Reporting 11
Setting up the System 11
TactiSys™ Quartz Equipment Hardware Installation 11
Location 11
Procedure 12
Cleaning and Disinfecting the System 12
Instructions 12
TactiSys™ Quartz Equipment Components 15
Important Information 15
Adverse Events 15
The TactiSys™ Quartz Equipment Hardware 15
Connections of the TactiSys™ Quartz Equipment Hard-
ware to the Other Parts of the System 15
Power Supply 15
TactiSys™ Quartz Equipment Hardware Front Panel 16
TactiSys™ Quartz Equipment Hardware Rear Panel 17
Procedures to Operate TactiSys™ Quartz Equipment
19
Switching on the TactiSys™ Quartz Equipment Hardware 19
Connecting a TactiCath™ Catheter 19
Starting an EnSite™ Contact Force Module Procedure 19
Replacing a TactiCath™ Catheter 19
Downloading Log Files from the TactiSys™ Quartz Equipment
Hardware 20
Technical Specifications 20
Inspections and Repairs 20
Maintenance 20
Hardware Maintenance 20
Routine Maintenance 21
Software Maintenance 21
Maintenance Contract 21
TactiSys™ Quartz Equipment Hardware Specifications 21
General 21
Mains Adapter 21
TactiSysTM Quartz Equipment Hardware Power Supply
(from Mains Adapter) 21
Protection 21
Electromagnetic Compatibility (EMC) 22
Physical Specifications 22
System Performances 22
F. total 22
F. lateral 22
F. axial 22
Compatibility with External Devices 22
Compatible RF Generator 22
Compatible Mapping System 22
Environmental Conditions 23
Operating Conditions 23
Transport and Storage Conditions 23
System Interconnections 25
List of Connections 25
List of Accessories 27
Compatible TactiCath™ Contact Force Ablation Catheter 27
Optional Accessories of TactiSys™ Quartz Equipment
Hardware and their Relevant Catalogue Numbers 27
Electromagnetic Compatibility 29
Electromagnetic Emissions 29
Electromagnetic Immunity 30
RF Portable Equipment 31
Recommended Separation Distances 33

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Chapter 3. Introduction
System Description 3
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Introduction
System Description
What Is It?
The TactiSys™ Quartz Equipment is part of a system for percutaneous catheter radiofrequency (RF) ablation of atrial cardiac
arrhythmias that allows visualization of the contact force between the tip of a TactiCath™ Contact Force Ablation Catheter and the
heart wall.
Use of the system to treat a specific cardiac arrhythmia is determined by the indications for use of the TactiCath Contact Force Ablation
Catheter.
TactiSys™ Quartz Equipment Hardware
The TactiSys Quartz Equipment hardware is a non-sterile active signal and data processing device that interconnects the TactiCath
Contact Force Ablation Catheter to an external RF generator.
The TactiSys Quartz Equipment hardware collects data from the catheter to compute the force and related information. TactiSys Quartz
Equipment hardware operates as a server, sending contact force information to the EnSite™ Contact Force Module (referred later in
this document as “Client”).
The TactiSys Quartz Equipment hardware is powered by a mains adapter, which is provided with the device.
Compatible Catheter
The TactiSys™ Quartz Equipment is intended to be used with a TactiCath™ Contact Force Ablation Catheter. The combination of the
two devices is referred to as the TactiCath™ Quartz Set.
Related Components
The following additional components are required for RF ablation procedures and to display contact force information:
•RF generator
•Irrigation pump
•EnSiteTM Cardiac Mapping System with EnSiteTM Contact Force Module
The following illustration shows how the devices are interconnected:

4 Chapter 3. Introduction
System Interconnections and List of Accessories
TactiSys™ Quartz Equipment Instructions for Use
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Main Functionalities
When used with a TactiCath™ Contact Force Ablation Catheter, the TactiSys™ Quartz Equipment hardware has the following main
functionalities:
•Contact force calculation
•Data transfer to Client (ie, EnSite Cardiac Mapping System with EnSite Contact Force Module)
•Transmitting intra-cardiac signals for monitoring
•Transmitting pacing signals
•Transmitting RF energy to the cardiac tissue
When used with the TactiSys Quartz Equipment hardware, the EnSite Contact Force Module has the following functionalities:
•Visualization and storage of the force information coming from the catheter tip during mapping and ablation
•Visualization of the contact force signal
System Interconnections and List of Accessories
See “System Interconnections” on page 25 for an overview of the TactiSys Quartz Equipment hardware interconnections with other
devices in the electrophysiology laboratory.

Chapter 4. Indications for Use
Important Safety Information 5
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Indications for Use
TactiSys™ Quartz Equipment and accessories are indicated for use in conjunction with a TactiCath™ 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 Contact Force Ablation Catheter and its indications for use, please refer to its Instructions
for Use (IFU).
Important Safety Information
WARNING: A warning indicates that there is a risk of injury to the patient or user.
CAUTION: A caution refers to a condition that may lead to damage or malfunction of the equipment.
NOTE: A note provides additional information.
Physician Training
Cardiac ablation procedures using the TactiCath™ Quartz Set must be performed by physicians who fully understand the working
principles of the TactiCath Quartz Set as described in this User Manual. Training on the TactiCath Quartz Set will be provided by
St. Jude Medical personnel or by trainers accredited by St. Jude Medical, at the installation of the TactiCath Quartz Set.
Physicians must be familiar with the techniques and be appropriately trained for cardiac mapping and ablation procedures and must
be authorized to conduct such procedures according to the laws and guidelines enforced in 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.
Safety Precautions
CAUTION:
This product complies with the Electromagnetic Compatibility Standard IEC 60601-1-2:2014 and needs to be installed and put
into service according to “Electromagnetic Compatibility (EMC)”.
Certain types of mobile telecommunication equipment could potentially interfere with this product. The separation distances
recommended in “Electromagnetic Compatibility (EMC)” 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.

6 Chapter 4. Indications for Use
Symbols
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Electromagnetic Compatibility
WARNING: This equipment has been tested for radiated RF immunity only at selected frequencies, and use nearby of emitters at other
frequencies could result in improper operation.
For information about electromagnetic compatibility, see “Electromagnetic Compatibility” on page 29.
Disposal
The User Manual is recyclable. Dispose of all packaging materials as appropriate. You can also return the device to the manufacturer
for disposal.
Symbols
The following symbols are used on TactiSys™ Quartz Equipment components:
Follow instructions for use
Consult Instructions for Use
Follow Instructions for Use on this Website
Caution
The applied part of the TactiCath™ Quartz Set is type CF for direct cardiac
application, and is defibrillator proofed

Chapter 4. Indications for Use
Symbols 7
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Affixed to this device in accordance with European Council Directives 2012/19/EU.
These directives call for separate collection and disposal of electrical and electronic
equipment. Sorting such waste and removing it from other forms of waste lessens
the contribution of potentially toxic substances into municipal disposal systems and
into the larger ecosystem.
Return the device to St. Jude Medical at the end of its operating life.
CAUTION: Federal (US) law restricts this device to sale by or on the order of a
physician
Keep dry
Fragile; handle with care
This way up
Temperature limitation
Connection of an HF isolated patient circuit
Power-off

8 Chapter 4. Indications for Use
Symbols
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Power-on
USB connection
Equipotential ground connection
Class II equipment
Manufacturer
Conformité Européenne (European Conformity). Affixed in accordance with
European Council Directive 93/42/EEC (NB 0086) and 2011/65/EU. Hereby, St. Jude
Medical declares that this device is in compliance with the essential requirements
and other relevant provisions of this directive.
Date of Manufacture
Quantity
Equipment

Chapter 4. Indications for Use
Symbols 9
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Do not use if package is open or damaged
Catalogue Number
Serial Number
Lot Number
RF Cable
For Use With
CE Mark
Pack
Adapter
Intertek Safety Agency Certification Mark
Medical Electrical Equipment

10 Chapter 4. Indications for Use
Symbols
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Computer network

Chapter 5. Installation
Receiving, Inspecting, and Returning the System 11
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Installation
Receiving, Inspecting, and Returning the System
Check for Completeness
After opening the TactiSys™ Quartz Equipment box PN-004 400, check whether you have received all of the following components:
NOTE: a. US, Australian, EU, and UK mains cords are included in the box.
b. Appropriate User Manual depends on your geographic location.
The TactiSys Quartz Equipment hardware shall be used with the following RF generator cable, which will be delivered in a separate
box:
The RF generator cable is required to connect the TactiSys Quartz Equipment hardware to the RF generator. An ablation procedure is
not possible without the RF generator cable.
Additional accessories may be used in conjunction with the TactiSys Quartz Equipment hardware. A list of optional accessories is
given in “List of Accessories” on page 27.
Damage Check and Reporting
When you receive the device, you should check for damage caused during the shipment.
In case the device was damaged during shipment, you should:
•Notify the shipping agent immediately.
•File a damage report to document claims for damages.
Setting up the System
TactiSys™ Quartz Equipment Hardware Installation
Location
The TactiSys Quartz Equipment hardware should be placed outside of the sterile field in the electrophysiology laboratory.
The Client should be placed outside the sterile field in the electrophysiology laboratory or in the control room.
Qty Name / Description
1 TactiSys™ Quartz Equipment hardware
1Ethernet cable 3 m
1 Mains adapter
4a Mains cord
1 Equipotential cable
1bUser Manual
Catalogue No. Name / Description
PN-004 515 TactiSysTM Quartz RF cable – Ampere™ Generator

12 Chapter 5. Installation
Cleaning and Disinfecting the System
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The site controlling the device should have policies in place prescribing the physical safety and security of the devices in the
electrophysiology laboratory. For example, physically securing devices and information should include policies that limit physical
access, securing equipment in locked rooms, managing access to secured rooms, and restricting the ability to remove devices from a
secure area.
WARNING: Do not obstruct the ventilation grid located on the bottom and the top of the TactiSysTM Quartz Equipment hardware case.
CAUTION: To avoid risk of damaging the TactiSysTM Quartz Equipment, make sure that the supporting surface is horizontal, stable,
and free from vibrations.
Procedure
To set up TactiSys™Quartz Equipment, proceed as follows:
1. Optional: Assemble the TactiSys Quartz Equipment hardware on the TactiSys™ Quartz 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 to the appropriate mains cord, and then to the TactiSysTM Quartz Equipment hardware power
socket. Connect the mains cord to the mains power supply.
3. Connect the TactiSys Quartz Equipment hardware to the EnSite™Cardiac Mapping System using the Ethernet cable.
4. Connect the green connector of the RF cable to the TactiSys Quartz Equipment hardware RF cable socket, and the other connector
into the RF generator.
5. Connect an equipotential cable to the TactiSys Quartz Equipment hardware equipotential socket.
WARNING: An overview of all the system interconnections can be found in “System Interconnections” on page 25. All combinations
of equipment must be in compliance with IEC 60601-1 (clause 16) Standard systems requirements. Anyone who
interconnects various types of medical equipment configures a medical system and is therefore responsible for ensuring
that the system complies with the requirements of system standard IEC 60601-1 (clause 16).
Inspect the Ethernet cable and verify the cable is intact between the TactiSys Quartz System and the Associate Switch
for the EnSite Cardiac Mapping System. In addition, verify that all connections to the Associate Switch are connected
only to St. Jude Medical-approved devices.
NOTE: To prevent dust from contaminating the devices when no optical cables are connected, always cover unused optical cable
ports with the protection cap. If there is no or intermittent output of the force sensor, carefully clean the optical connector
using a lint-free swab soaked with 99% isopropyl alcohol solution and then dry the optical connector with a new lint-free
swab without alcohol.
Use only the mains adapter, cables, and other accessories provided by St. Jude Medical with the TactiSys Quartz
Equipment hardware (see “List of Accessories” on page 27).
Cleaning and Disinfecting the System
Instructions
To avoid complications due to contamination of the system components, clean and decontaminate them before and after use.

Chapter 5. Installation
Cleaning and Disinfecting the System 13
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The following table shows how to clean and disinfect the system components:
WARNING: Electrical shock hazard: The TactiSys™Quartz Equipment hardware must be switched off and disconnected from the
mains adapter before it is cleaned. No liquid should enter the equipment. Make sure that any remaining liquid on the
devices and cables has dried before switching the system on.
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 (eg, gas, steam, hot air).

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Cleaning and Disinfecting the System
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Chapter 6. TactiSys™ Quartz Equipment Components
Important Information 15
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TactiSys™ Quartz Equipment Components
Important Information
WARNING: Do not spill liquid on TactiSysTM Quartz Equipment hardware components.
CAUTION: To avoid malfunction, cables and accessories should be visibly inspected prior to use and plug-in/unplug of cables should
be carried out with care. Cables with damaged insulation should not be used.
To avoid damage, do not use acetone-containing agents to clean the TactiSys Quartz Equipment hardware. The device
surface, including labeled panels, can be cleaned using a soft cloth with soap and water or soft detergents.
To avoid system malfunction, do not connect the interface connector (optical fiber) for fiber optics to an external voltage
source.
Adverse Events
See adverse event information in the IFU of the TactiCath™ Contact Force Ablation Catheter that you intend to use with TactiSys
Quartz Equipment hardware.
NOTE: To maintain system isolation, only medical electrical equipment certified to IEC 60601-1 may be connected to the
TactiSys Quartz Equipment hardware. Respect the minimum safety distance between the electrical devices and the
patient according to “Electromagnetic Compatibility” on page 29.
The TactiSys™ Quartz Equipment Hardware
Connections of the TactiSys™Quartz Equipment Hardware to the Other Parts of the System
NOTE: See “System Interconnections” on page 25 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.
The TactiSys™Quartz Equipment Hardware is
Connected to the ...
By ...
Client (26) An Ethernet cable
RF Generator (27) An electrical interface cable connected to the rear
panel (24)
TactiCath™ Contact Force Ablation Catheter
(sold separately)
The connection cable (3) of the TactiCath™ Con-
tact Force Ablation Catheter, consisting of one
electrical connector (5) and one optical connector
(6)

16 Chapter 6. TactiSys™ Quartz Equipment Components
Important Information
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TactiSys™ Quartz Equipment Hardware Front Panel
Item number Part Function
7 Reset Button To reset the force values to baseline
8 Power indicator Lit when the TactiSys™ Quartz Equipment
hardware is powered
9 Electrical socket for TactiCath™
Contact Force Ablation Catheter
Accepts TactiCath™ Contact Force Ablation
Catheter electrical connector
10 Optical socket for TactiCath Contact
Force Ablation Catheter
Accepts TactiCath™ Contact Force Ablation
Catheter optical connector

Chapter 6. TactiSys™ Quartz Equipment Components
Important Information 17
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TactiSys™ Quartz Equipment Hardware Rear Panel
Item Number Part Function
11 ON/OFF switch Switch on/off TactiSys™ Quartz Equipment hardware
12 Power socket Connection to mains power supply (via combination of
mains cord and mains adapter)
13 Ethernet socket Connection to Client (EnSite™ Cardiac Mapping System
with EnSite Contact Force Module) to display contact force
information
14 USB port Accept mass storage device
15 RF cable socket Connection to the “catheter” connector of the RF generator
16 X1 serial port Nonfunctional
17 Equipotential socket For equalization of the ground potential

18 Chapter 6. TactiSys™ Quartz Equipment Components
Important Information
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