Boston Scientific RHYTHMIA HDx IntellaNav StablePoint Mode D'emploi page 3

RHYTHMIA HDx
Ablation Connection Box -
IntellaNav StablePoint™
ONLY
Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician.
Note: The equipment documented in this manual is supplied non-sterile and cannot be
sterilized. The equipment is intended for multi-patient reuse.
DEVICE DESCRIPTION
The RHYTHMIA HDx Ablation Connection Box enables use of the radiofrequency (RF)
generator and IntellaNav StablePoint Ablation Catheter with the mapping system. The
ablation connection box routes intracardiac signals and location and force information sensed
by the ablation catheter to the mapping system and prevents RF energy from affecting
catheter localization and other mapping system features. The ablation connection box also
passes catheter tip temperature and catheter tip impedance information, as well as RF energy
between the RF generator and ablation catheter.
Contents
One (1) RHYTHMIA HDx Ablation Connection Box - IntellaNav StablePoint.
Operating Principle
The RHYTHMIA HDx Mapping System is a 3D mapping and navigation system used in
electrophysiological (EP) procedures. The system employs two mechanisms to perform 3D
mapping and navigation: (a) continuous mapping based on patient cardiac signals acquired
from intracardiac catheters and surface ECG electrodes, and (b) continuous localization of
magnetic and impedance tracked catheters.
User Information
Operation of the device is restricted to licensed medical practitioners and Boston Scientific
mapping specialists. Only users who meet these criteria should use the device.
INTENDED USE / INDICATIONS FOR USE
The RHYTHMIA HDx Ablation Connection Box - IntellaNav StablePoint is intended for use with
the Maestro 4000 RF Generator and IntellaNav StablePoint Ablation Catheter during mapping
and ablation procedures.
Clinical Benefit Statement
The benefit of the Ablation Connection Boxes is to provide a connection between 3rd party
or Boston Scientific ablation catheters to 3rd party or Boston Scientific RF generators and
the Rhythmia HDx Mapping System's Signal Station (SiS) in order to allow the SiS to acquire
the intracardiac signals and location information from the ablation catheter. The ablation
connection box also passes catheter tip temperature and catheter tip impedance information,
as well as RF energy between the RF generator and ablation catheter.
The Rhythmia HDx Mapping System is an effective diagnostic tool for EP procedures. When
used with the IntellaMap Orion mapping catheters or the IntellaNav ablation catheters, the
Rhythmia HDx Mapping System provides real-time visualization of intracardiac catheters and
a display of cardiac maps in selected formats in minimally invasive procedures to assist the
physician in identifying the origin of the arrhythmia within the heart chamber.
CONTRAINDICATIONS
There are no known contraindications.
WARNINGS
The RHYTHMIA HDx Ablation Connection Box is intended for use with other medical devices
in an Electrophysiology (EP) laboratory.
• Carefully read the Instructions for Use (IFU) documents for every medical device that will
be used during a study, prior to each study. Be sure to fully understand and consistently
follow all warnings, cautions, and instructions. Failure to properly follow the instructions
may cause equipment damage, system malfunction, or harm to the patient or user.
• Use only Maestro 4000 RF Generators with the StablePoint Ablation Connection Box. Do
not use with other RF generators. Compatibility with other RF generators has not been
demonstrated.
• Do not exceed RF generator power limits set by the manufacturer.
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PRECAUTIONS
General
• Carefully inspect the device prior to each use. Do not use any component that shows
evidence of being damaged or defective.
• Do not drop the device or subject it to extreme shock. Dropping the device or forcefully
hitting it against hard objects may damage components and cause device malfunction.
Contact Boston Scientific Support for device repair or replacement.
Cables
• Do not use excessive force when connecting or disconnecting cable connectors. Excessive
force can damage the connectors, which may cause device malfunction.
• Do not kink or bend cables. Kinks and sharp bends can damage the cables, which may
cause device malfunction.
Environmental
• Avoid exposing the device to excessive moisture, heat or cold. Using the device in
environmental conditions that exceed recommendations may affect operation. For
specific environmental guidelines, see How Supplied section.
• When connecting or disconnecting device cables, protect the cable connectors from water
or moisture. Wet connectors may affect device operation.
• Do not immerse any cable connectors in water or liquid. Immersion in water or liquid may
damage connectors, which may cause device malfunction.
• Always follow guidelines for equipment storage and transport. Storage or transport in
extreme environmental conditions can damage device. For specific storage and handling
guidelines, see How Supplied section.
Cleaning and Disinfecting
• Do not immerse device components in water, cleaning solutions, or liquid. Ensure
connectors stay dry. Failure to follow cleaning guidelines may cause device damage or
malfunction, and may also void any warranties or service agreements.
• To avoid equipment damage and malfunction, do not attempt to sterilize equipment that
is provided non-sterile.
• To avoid equipment damage and malfunction, do not insert anything (e.g., cotton swabs
or pins) into cable connectors or equipment ports or openings.
• Do not use the device if it is soiled or contaminated with infectious, or potentially
infectious, materials. Using soiled or contaminated items increases the risk of patients
acquiring serious infections or contaminating other patients or users. Soiled or
contaminated cables and equipment must be removed from use and either cleaned
according to established facility protocol procedures or replaced.
• Always clean multiple-use equipment according to established facility protocol prior to
each use.
• Do not use disinfectants such as glutaraldehyde or hydrogen peroxide to clean device.
• Do not use solvents such as acetone to clean device.
Repair or Replacement
• Use only the equipment, supplies, and accessories supplied or recommended by Boston
Scientific. The use of other equipment, supplies, and accessories may cause equipment
damage or malfunction.
• Do not attempt to repair, modify, or open any part of the device. Repair attempts by
untrained, unauthorized individuals may cause user injury, equipment damage, or
malfunction. Contact Boston Scientific Support for device repair or replacement.
ADVERSE EVENTS
Any potential clinical complications are in large part expected to be related to the accessory
diagnostic or ablation catheters that are used with the system, rather than the system
itself. In order to identify potential adverse events, the user is instructed to read pertinent
directions for use documents associated with the catheters and ablation generators that will
be employed during a mapping session.
As with other mapping systems, the RHYTHMIA HDx Mapping System can be incidentally
associated with minor or major clinical complications intrinsic to intracardiac procedures.
Potential adverse events associated with the use of the system include, but are not limited
to, the following:
Arrhythmias
Due to the programmed electrical stimulation performed during EP diagnostic procedures
and catheter manipulations, patients undergoing EP procedures are at potential risk of
arrhythmia. While the device has no active role in RF ablation, a risk does exist that the
effectiveness of an RF ablation procedure could be suboptimal and cause the targeted
arrhythmia to reoccur.
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Black (K) ∆E ≤5.0