St. Jude Medical TactiSys Quartz Equipment User Manual
  1. Manuals
  2. Brands
  3. St. Jude Medical Manuals
  4. Medical Equipment
  5. TactiSys Quartz Equipment
  6. User manual

St. Jude Medical TactiSys Quartz Equipment User Manual

Hide thumbs
Table of Contents

Advertisement

Quick Links

TactiSys
Model PN-004 400
U.S.
Edi-
tion
St. Jude Medical
One St. Jude Medical Drive
St. Paul, MN
55117-9913 USA
+1 855 478 5833
+1 651 756 5833
sjm.com
Pat. http://patents.sjm.com
Quartz Equipment
™
User Manual
I
NSTRUCTIONS FOR
U.S. E
DITION
© 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
U
SE
2018-10

Advertisement

Table of Contents
loading
Need help?

Need help?

Do you have a question about the TactiSys Quartz Equipment and is the answer not in the manual?

Questions and answers

Subscribe to Our Youtube Channel

Related Manuals for St. Jude Medical TactiSys Quartz Equipment

Summary of Contents for St. Jude Medical TactiSys Quartz Equipment

  • Page 1 Edi- tion 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.
  • Page 2 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.

  • Page 3: Table Of Contents

    TactiSys™ Quartz Equipment Instructions for Use ARTEN600027149 Table of Contents Table of Contents 1 TactiSysTM Quartz Equipment Hardware Power Supply (from Mains Adapter) 21 Protection 21 Introduction 3 Electromagnetic Compatibility (EMC) 22 System Description 3 Physical Specifications 22 What Is It? 3 System Performances 22 TactiSys™...
  • Page 4 TactiSys™ Quartz Equipment Instructions for Use ARTEN600027149...

  • Page 5: Introduction

    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”).

  • Page 6: Main 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.

  • Page 7: Indications For Use

    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.

  • Page 8: Electromagnetic Compatibility

    Chapter 4. Indications for Use TactiSys™ Quartz Equipment Instructions for Use ARTEN600027149 Symbols 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”...
  • Page 9 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...
  • Page 10 Chapter 4. Indications for Use TactiSys™ Quartz Equipment Instructions for Use ARTEN600027149 Symbols 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.
  • Page 11 TactiSys™ Quartz Equipment Instructions for Use Chapter 4. Indications for Use ARTEN600027149 Symbols 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...
  • Page 12 Chapter 4. Indications for Use TactiSys™ Quartz Equipment Instructions for Use ARTEN600027149 Symbols Computer network...

  • Page 13: Installation

    US, Australian, EU, and UK mains cords are included in the box. Appropriate User Manual depends on your geographic location. The TactiSys Quartz Equipment hardware shall be used with the following RF generator cable, which will be delivered in a separate box: Catalogue No.

  • Page 14: Procedure

    Cardiac Mapping System using the Ethernet cable. ™ 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. Connect an equipotential cable to the TactiSys Quartz Equipment hardware equipotential socket.
  • Page 15 TactiSys™ Quartz Equipment Instructions for Use Chapter 5. Installation ARTEN600027149 Cleaning and Disinfecting the System The following table shows how to clean and disinfect the system components: Do … Do not … • Switch the TactiSys Quartz Equipment • Use flammable and explosive agents to clean and ™...
  • Page 16 Chapter 5. Installation TactiSys™ Quartz Equipment Instructions for Use ARTEN600027149 Cleaning and Disinfecting the System...

  • Page 17: Tactisys™ Quartz Equipment Components

    (5) and one optical connector 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.

  • Page 18: Tactisys™ Quartz Equipment Hardware Front Panel

    Chapter 6. TactiSys™ Quartz Equipment Components TactiSys™ Quartz Equipment Instructions for Use ARTEN600027149 Important Information TactiSys™ Quartz Equipment Hardware Front Panel Item number Part Function Reset Button To reset the force values to baseline Power indicator Lit when the TactiSys™ Quartz Equipment hardware is powered Electrical socket for TactiCath™...

  • Page 19: Tactisys™ Quartz Equipment Hardware Rear Panel

    TactiSys™ Quartz Equipment Instructions for Use Chapter 6. TactiSys™ Quartz Equipment Components ARTEN600027149 Important Information TactiSys™ Quartz Equipment Hardware Rear Panel Item Number Part Function ON/OFF switch Switch on/off TactiSys™ Quartz Equipment hardware Power socket Connection to mains power supply (via combination of mains cord and mains adapter) Ethernet socket Connection to Client (EnSite™...
  • Page 20 Chapter 6. TactiSys™ Quartz Equipment Components TactiSys™ Quartz Equipment Instructions for Use ARTEN600027149 Important Information...

  • Page 21: Procedures To Operate Tactisys™ Quartz Equipment

    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.

  • Page 22: Downloading Log Files From The Tactisys™ Quartz Equipment Hardware

    Inspections and Repairs To ensure device safety, only St. Jude Medical (or an agent who has been expressively authorized by St. Jude Medical) is to complete maintenance, repairs, and technical safety inspections of the TactiSys Quartz Equipment and its accessories.

  • Page 23: Routine Maintenance

    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. Software Maintenance The software maintenance is performed by St. Jude Medical qualified personnel or by maintenance personnel accredited by St. Jude Medical. Maintenance Contract If desired, a maintenance contract can be arranged with the manufacturer.

  • Page 24: Electromagnetic Compatibility (Emc)

    Lateral force display resolution: 1 g F. axial Axial force display range: 0 to 990 g Axial force display resolution: 1 g Compatibility with External Devices Compatible RF Generator St. Jude Medical Ampere RF Generator ™ Compatible Mapping System EnSite Cardiac Mapping System with EnSite Contact Force Module ™...

  • Page 25: Environmental Conditions

    TactiSys™ Quartz Equipment Instructions for Use Chapter 7. Procedures to Operate TactiSys™ Quartz Equipment ARTEN600027149 Environmental Conditions 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) Thermocouple Type T Irrigation flow temperature:...
  • Page 26 Chapter 7. Procedures to Operate TactiSys™ Quartz Equipment TactiSys™ Quartz Equipment Instructions for Use ARTEN600027149 Environmental Conditions...

  • Page 27: System Interconnections

    TactiSys™ Quartz Equipment Instructions for Use System Interconnections ARTEN600027149 List of Connections System Interconnections List of Connections The item numbers correspond with the numbers in the illustration. Item Name / Description Number TactiCath™ Contact Force Ablation Catheter distal tip TactiCath™ Contact Force Ablation Catheter handle TactiCath™...
  • Page 28 System Interconnections TactiSys™ Quartz Equipment Instructions for Use ARTEN600027149 List of Connections Optical socket for the TactiCath™ Contact Force Ablation Catheter ON/OFF switch Power socket Ethernet socket USB port RF cable socket X1 serial port (not supported) Equipotential socket Ethernet cable connector Mains adapter connector RF cable connector TactiSys™...

  • Page 29: List Of Accessories

    TactiSys™ Quartz Equipment Instructions for Use List of Accessories ARTEN600027149 Compatible TactiCath™ Contact Force Ablation Catheter List of Accessories Compatible TactiCath™ Contact Force Ablation Catheter For the list of all TactiCath Contact Force Ablation Catheter models compatible with the TactiSys Quartz Equipment, please refer ™...
  • Page 30 List of Accessories TactiSys™ Quartz Equipment Instructions for Use ARTEN600027149 Optional Accessories of TactiSys™ Quartz Equipment Hardware and their Relevant Catalogue Numbers...

  • Page 31: Electromagnetic Compatibility

    TactiSys™ Quartz Equipment Instructions for Use Electromagnetic Compatibility ARTEN600027149 Electromagnetic Emissions 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 –...

  • Page 32: Electromagnetic Immunity

    Electromagnetic Compatibility TactiSys™ Quartz Equipment Instructions for Use ARTEN600027149 Electromagnetic Immunity 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. To avoid possible interference with any electromagnetic emitters that do not conform with this environment, ensure that these emitter sources are disabled or removed from the environment.

  • Page 33: Rf Portable Equipment

    TactiSys™ Quartz Equipment Instructions for Use Electromagnetic Compatibility ARTEN600027149 RF Portable Equipment 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. To avoid possible interference with any electromagnetic emitters that do not conform with this environment, ensure that these emitter sources are disabled or removed from the environment.
  • Page 34 Electromagnetic Compatibility TactiSys™ Quartz Equipment Instructions for Use ARTEN600027149 RF Portable Equipment Immunity Test IEC 60601 Compliance Electromagnetic Environment – Level Test Level 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.

  • Page 35: Recommended Separation Distances

    TactiSys™ Quartz Equipment Instructions for Use Electromagnetic Compatibility ARTEN600027149 Recommended Separation Distances Recommended Separation Distances This topic includes recommended separation distances between portable and mobile RF communications equipment and the device. 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.
  • Page 36 Electromagnetic Compatibility TactiSys™ Quartz Equipment Instructions for Use ARTEN600027149 Recommended Separation Distances...

This manual is also suitable for:

Pn-004 400

Table of Contents

Save PDF