Boston Scientific REF3200 Bedienungsanleitung

Q-TECH™ PROGRAMMER

A COMPONENT OF THE S-ICD®SYSTEM

USER’S MANUAL

3200

Limited Software License and Equipment Use.

S-ICD®, SQ-RX®, and Q-TRAK® are all registered trademarks of Cameron Health, Inc.

Q-GUIDE™ and Q-TECH™ are all trademarks of Cameron Health, Inc.

Manuals or other written documentation may not be copied or distributed without Cameron Health, Inc.

authorization.

Cameron Health, Inc.

905 Calle Amanecer

Suite 300

San Clemente, CA 92673

USA

1 800 CARDIAC (227 3422)

+1 651 582 4000

www.cameronhealth.com

Cameron Health BV

World Trade Center

Nieuwe Stationsstraat 10

6811 KS Arnhem

The Netherlands

1 800 CARDIAC (227 3422)

+1 651 582 4000

www.cameronhealth.com

TABLE OF CONTENTS

GENERAL DESCRIPTION

Description ................................................................................................................................1

Indications for Use ....................................................................................................................1

Contraindications .....................................................................................................................1

Programmer Warnings and Cautions ......................................................................................1

General....................................................................................................................................................................1

Electrostatic Discharge (ESD)..........................................................................................................................3

S-ICD System Warnings and Cautions .....................................................................................3

General....................................................................................................................................................................3

Use of Other Medical Therapies/Diagnostic Procedures ......................................................................4

Electromagnetic Interference (EMI) Outside the Hospital Environment ........................................5

Potential Adverse Events..................................................................................................................................5

OPERATION

Setup of the Q-TECH Programmer...........................................................................................7

Packaging...............................................................................................................................................................7

Charging the Programmer...............................................................................................................................7

Using the Q-TECH Programmer................................................................................................8

Turning the Programmer On...........................................................................................................................8

Placing the Programmer in Suspend Mode...............................................................................................9

Turning the Programmer O........................................................................................................................ 10

Using the Programmer Touch Screen ....................................................................................................... 10

Using the Wand................................................................................................................................................. 10

Navigation .......................................................................................................................................................... 12

Screen Header ................................................................................................................................................... 12

Navigation Bar................................................................................................................................................... 12

Restarting the Programmer.......................................................................................................................... 14

Conguring the Q-TECH Programmer.................................................................................. 15

Conguring Programmer Settings............................................................................................................. 15

Date and Time Format.................................................................................................................................... 17

Time Zone........................................................................................................................................................... 17

Language Preference...................................................................................................................................... 18

Printer Selection ............................................................................................................................................... 18

Programmer Software Version .................................................................................................................... 21

Modes of Operation for the Q-TECH Programmer............................................................... 21

Online Behavior ................................................................................................................................................ 21

Oine Behavior ................................................................................................................................................ 22

Modes of Operation for the SQ-RX Device........................................................................... 23

Shelf Mode.......................................................................................................................................................... 23

Therapy On Mode ............................................................................................................................................ 23

Therapy O Mode............................................................................................................................................ 23

Connecting and Disconnecting from the SQ-RX Device ..................................................... 24

Scanning For SQ-RX Devices........................................................................................................................ 24

Connecting to the SQ-RX Device................................................................................................................ 26

Connecting to an SQ-RX Device in Shelf Mode:.................................................................................... 26

Ending a Patient Session ............................................................................................................................... 27

Programming the SQ-RX Device at Implant ........................................................................ 29

Entering Electrode Information .................................................................................................................. 29

Creating the Patient Chart ............................................................................................................................ 31

Automatic Setup............................................................................................................................................... 33

Programming Therapy Parameters............................................................................................................ 36

Debrillation Testing....................................................................................................................................... 39

Performing an SQ-RX Follow-up........................................................................................... 42

Sensing Conguration and Automatic Setup........................................................................................ 42

Viewing SQ-RX Device Status ...................................................................................................................... 42

Viewing Stored Episodes............................................................................................................................... 44

Printing Reports from the Programmer............................................................................... 45

Printing Reports................................................................................................................................................ 45

Summary Report .............................................................................................................................................. 46

Captured S-ECG Report.................................................................................................................................. 47

Episodes Report................................................................................................................................................ 48

S-ECG Features ....................................................................................................................... 49

S-ECG Rhythm Strip Markers........................................................................................................................ 49

S-ECG Scale Settings ....................................................................................................................................... 50

Capture and View S-ECG Strips.................................................................................................................... 51

Utilities Menu ......................................................................................................................... 52

Acquire Reference S-ECG............................................................................................................................... 53

Beeper Control .................................................................................................................................................. 53

Manual Setup..................................................................................................................................................... 55

Smart Charge..................................................................................................................................................... 57

OPERATION (continued)

Additional Programmer Functions....................................................................................... 59

Rescue Shock..................................................................................................................................................... 59

Manual shock..................................................................................................................................................... 61

S-ICD System Magnet Model 4520 ............................................................................................................ 61

MAINTENANCE

Charging the Programmer............................................................................................................................ 62

Cleaning the Programmer............................................................................................................................. 62

Service.................................................................................................................................................................. 63

Maintenance Check......................................................................................................................................... 63

Safety Measurements ..................................................................................................................................... 63

Programmer End of Life ................................................................................................................................ 63

TROUBLESHOOTING

Inability to Print ................................................................................................................................................ 64

No Printer Available......................................................................................................................................... 64

Touch Screen Inactive while Connected to AC Power........................................................................ 64

Loss of Communication with Printer......................................................................................................... 65

Inability to Communicate With the SQ-RX Device............................................................................... 65

COMPLIANCE STATEMENTS

Federal Communications Commission (FCC) US.................................................................................. 66

1999/5/EC (R&TTE Directive)........................................................................................................................ 66

EMI/RFI ................................................................................................................................................................. 66

DECLARATIONS TABLES

Declaration Electromagnetic Emission .................................................................................................... 67

Declaration Electromagnetic Immunity Part 1...................................................................................... 67

Declaration Electromagnetic Immunity Part 2...................................................................................... 68

Recommended Separation Distances ...................................................................................................... 69

EMI/RFI Information ........................................................................................................................................ 69

SPECIFICATIONS

Product Guidelines .......................................................................................................................................... 70

Specications..................................................................................................................................................... 70

Nominal Specications .................................................................................................................................. 71

DEFINITION OF PACKAGE LABEL SYMBOLS

Packaging Symbols: Q-TECH Programmer.............................................................................................. 72

Packaging Symbols: Q-TECH Programmer Wand ................................................................................. 73

WARRANTY

Warranty.............................................................................................................................................................. 74

QTECH™ PROGRAMMER: GENERAL DESCRIPTION

Description

The Q-TECH Programmer (the“programmer”), Model 3200, is a component of the Cameron Health/

Boston Scientic S-ICD System, which is prescribed for patients when cardiac arrhythmia management

is warranted. The other components of the S-ICD System include the SQ-RX Pulse Generator (the“SQ-

RX device”), Q-TRAK Subcutaneous Electrode (“electrode”) and the Q-GUIDE Subcutaneous Electrode

Insertion Tool (“EIT”). The programmer communicates wirelessly with the SQ-RX device to enable

adjustment of programmable settings and data collection. The S-ICD System is designed for ease of use

and simplicity of patient management. The S-ICD System has a number of automatic functions designed

to reduce the amount of time required for implantation, initial programming and patient follow-up.

Indications for Use

The S-ICD System is intended to provide debrillation therapy for the treatment of life-threatening

ventricular tachyarrhythmias in patients who do not have symptomatic bradycardia, incessant

ventricular tachycardia, or spontaneous, frequently recurring ventricular tachycardia that is reliably

terminated with anti-tachycardia pacing.

Contraindications

Unipolar pacemakers are contraindicated for use with the S-ICD System.

Programmer Warnings and Cautions

General

• External debrillation equipment should be available for immediate use during the

implantation procedure and follow-up.

• Use the programmer only with the external power supply packaged with the programmer.

Using other accessories may cause damage to the programmer.

• The US power cord is for connection to 110 VAC supply mains. All other power cords are for

connection to 230 VAC supply mains. Outside North America, use the supplied power cord that

exactly matches your AC electrical outlet.

• To avoid risk of electric shock, the programmer must only be connected to a supply mains with

protective earth.

• Mains isolation is achieved by disconnecting the AC power cord. Do not position the programmer

or the external power supply in a manner that would make it dicult to disconnect that cord.

• Never use a damaged external power supply or a damaged programmer.

QTECH™ PROGRAMMER: GENERAL DESCRIPTION

• The programmer is not waterproof or explosion-proof and it cannot be sterilized. Do not use

it in the presence of ammable gas mixtures, including anesthetic mixtures containing air,

oxygen, or nitrous oxide.

• Conrm that the programmer is in communication with the intended implanted SQ-RX Pulse

Generator.

• The programmer is intended for use by healthcare professionals only. The programmer

may cause radio interference or may disrupt the operation of nearby equipment. It may be

necessary to take mitigation measures, such as reorienting or relocating the programmer or

shielding the location.

• By design, the programmer emits radio frequencies (403.5 MHz and 2.5 GHz). This may interfere

with nearby equipment. Closely monitor medical electrical equipment in the vicinity when

using the programmer.

• The presence of other equipment in the same frequency band (403.5 MHz for the SQ-RX Pulse

Generator and 2.5 GHz for the printer) may interfere with communication. If communication

problems occur, refer to the Troubleshooting section of this manual.

• If the programmer is used near other medical or oce equipment, all equipment should be

observed to verify normal operation. Other equipment may interfere with the programmer,

even if that other equipment complies with the International Special Committee on Radio

Interference (CISPR) emission requirements.

• Use of non-Cameron Health/Boston Scientic-approved accessories may result in increased

emissions or decreased functionality of the programmer and may cause unintended

operational behavior of the programmer.

• No modication of the programmer is allowed.

• Use only the Cameron Health/Boston Scientic S-ICD programmer and appropriate software to

communicate with and program the SQ-RX Pulse Generator.

• Do not discard the programmer in a re, incinerate, or subject it to temperatures that exceed

100° C (212° F). This could cause the programmer to explode.

• Do not disassemble or alter any parts of the programmer.

• Do not immerse the programmer in liquid of any kind. If the programmer does get wet, contact

customer service for information about returning the programmer to Cameron Health/Boston

Scientic. Do not attempt to dry the programmer in an oven, microwave, or dryer because this

poses a risk of overheating or explosion.

QTECH™ PROGRAMMER: GENERAL DESCRIPTION

• Do not subject the programmer to temperatures outside of the -10° C to 55° C (14° F to 131° F)

storage range. Exposure to high temperatures may cause the programmer to overheat or ignite,

and may possibly reduce its performance and service life.

• Mishandling (such as dropping or crushing) could damage the programmer. If you suspect

damage to the programmer, contact your Cameron Health/Boston Scientic representative or the

customer service department for instructions and return packaging.

• The display on the programmer is made of glass or acrylic and could break if the programmer is

dropped or if it receives signicant impact. Do not use if screen is broken or cracked as this could

cause injury .

• Contact your Cameron Health/Boston Scientic representative or the customer service

department for assistance or a replacement part.

Electrostatic Discharge (ESD)

The programmer may be aected by ESD. If ESD occurs and the programmer’s functionality is

aected, attempt to reset the programmer or contact your Cameron Health/Boston Scientic

representative or the customer service department for instructions.

• Do not touch or connect the telemetry wand to the programmer unless ESD precautionary

procedures are used.

S-ICD System Warnings and Cautions

Before using the S-ICD System, read and follow all warnings and cautions provided in this manual. Refer

to the SQ-RX Pulse Generator, Q-TRAK Electrode or Q-GUIDE Electrode Insertion Tool User’s Manuals for

information on implanting and explanting the S-ICD System.

The S-ICD System contains sterile products for single use only. Do not resterilize. Handle the

components of the S-ICD System with care at all times and maintain proper sterile technique.

General

• External debrillation equipment should be available for immediate use during the

implantation procedure and follow-up.

• Placing a magnet over the SQ-RX Pulse Generator suspends arrhythmia detection and therapy

response. Removing the magnet resumes arrhythmia detection and therapy response.

• Battery depletion will eventually cause the SQ-RX Pulse Generator to stop functioning.

Debrillation and excessive numbers of charging cycles shorten the SQ-RX Pulse Generator’s

battery longevity.

QTECH™ PROGRAMMER: GENERAL DESCRIPTION

• The S-ICD System has not been evaluated for pediatric use.

• The S-ICD System does not provide long-term bradycardia pacing, Cardiac Resynchronization

Therapy (CRT) or Anti-Tachycardia Pacing (ATP).

Use of Other Medical Therapies/Diagnostic Procedures

• External debrillation or cardioversion may damage the S-ICD System. Avoid placing the

debrillation paddles directly over the SQ-RX device or electrode.

• Cardio Pulmonary Resuscitation (CPR) may temporarily interfere with sensing and may cause

delay of therapy.

• Do not expose a patient with an implanted S-ICD System to diathermy. The interaction of

diathermy therapy with an implanted SQ-RX Pulse Generator can damage the SQ-RX Pulse

Generator and cause patient injury.

• Do not expose the patient to MRI scanning. MRI scanning can damage the SQ-RX Pulse

Generator and cause patient injury.

• Electrical interference or “noise” from sources such as electrosurgical and monitoring

equipment can interfere with the communication between the programmer and SQ-RX Pulse

Generator or cause inappropriate therapy. If interference occurs, move and reposition the

programmer or wand away from the source of the interference.

• Ionizing radiation therapy, such as radioactive cobalt, linear accelerators, and betatrons

may adversely aect the S-ICD System operation. Therapeutic ionizing radiation cannot be

immediately detected; however, it can damage the electronic components of the SQ-RX Pulse

Generator. To minimize the risks of ionizing radiation:

» Shield the SQ-RX Pulse Generator with a radiation-resistant material, regardless of the

distance between the SQ-RX Pulse Generator and the radiation beam.

» Do not project the radiation port directly at the SQ-RX Pulse Generator.

» Evaluate the S-ICD System operation after each radiation treatment.

• Lithotripsy and other therapeutic forms of ultrasound can damage the SQ-RX Pulse Generator.

If required, avoid direct ow of the pulse waves near the site of the implanted SQ-RX Pulse

Generator.

• Use caution during ablation procedures. Program the S-ICD System to Therapy O. Keep the

current path (electrode tip to ground) as far away as possible from the implanted SQ-RX Pulse

Generator and electrode.

• The programmer is not suitable for use in the presence of a ammable anesthetic mixture with

air or with oxygen or nitrous oxide.

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