Johnson & Johnson Biosense Webster RefStar RMT Instrucciones De Uso página 3

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R S RMT External Reference Patch
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• NON-STERILE.
• For single use only.
• Do not use if package is open or damaged.
• Federal law (U.S.A.) restricts this device to sale by or on the order of a physician.
DEVICE DESCRIPTION
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The Biosense Webster R S RMT External Reference Patch is an integral part of a non-
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fluoroscopic catheter tip location and electrogram capture technology called C
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System. When used with the C RMT system, the intracardiac location of the
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N S RMT Mapping Catheter tip is compared to the location of this reference patch.
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This reference device consists of a sensor embedded in an adhesive patch, which is
connected to a handle that houses the printed circuit board.
CONSULT THE LOCAL DISTRIBUTOR OR MANUFACTURER FOR THE APPROPRIATE
INTERFACE CABLES.
INDICATIONS
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The Biosense Webster R S RMT External Reference Patch is indicated for use with
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the N S RMT Catheter and the C
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well as electrogram information.
CONTRAINDICATIONS
There are no known contraindications for the use of the external reference patch.
WARNINGS
• Do not immerse the proximal handle or cable connector in fluids; electrical performance
could be affected.
• Do not expose the external reference patch to organic solvents such as alcohol.
• Do not autoclave the external reference patch.
PRECAUTIONS
• Do not attempt to use the Biosense Webster R
prior to completely reading and understanding these Instructions For Use.
• This device is for external use only.
• Store in a cool, dry place. Inspect the packaging and external reference patch prior to
use.
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• The Biosense Webster R S
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patient use only.
• Do not resterilize and reuse.
• This device is packaged and sterilized for single use only. Do not reuse, reprocess or
resterilize. Reuse, reprocessing, or resterilization may compromise the structural
integrity of the device and/or lead to device failure that in turn may result in patient
injury, illness or death. Also, reprocessing or resterilization of single use devices may
create a risk of contamination and/or cause patient infection or cross-infection, including,
but not limited to, the transmission of infectious disease(s) from one patient to another.
Contamination of the device may lead to injury, illness, or death of the patient.
"USE BY" DATE
Use the device prior to the "Use By" date on the package label.
DISPOSAL
Recycle components, or dispose of the product and its residual elements or waste items in
accordance with local laws and regulations.
SUGGESTED INSTRUCTIONS FOR USE
Please refer to these Instructions for Use, the Biosense Webster N
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Instructions for Use, and the C RMT System User Manual when using the
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R S RMT External Reference Patch in conjunction with the N
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and the C RMT System.
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• Remove the external reference patch from its package. Affix the patch to the patient's
back (as shown below). Connect the proximal handle of the patch to the appropriate
equipment.
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• The R S RMT External Reference Patch
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should be securely positioned on the patient's back.
The patch should be placed below the scapula in the
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area of the seventh (for C RMT System)
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thoracic vertebra. The body (shaft) of the reference
device should follow the long axis of the patient
towards the feet or head. Both the patch and the
body of the reference device should be securely
positioned and taped in such a manner as not to
subject the device to any abnormal stresses during
the procedure which may dislodge the reference
device from its location. The handle of the reference
device should be connected to the appropriate
connection scheme leading to the C
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C RMT System software program is equipped with a positional reference location
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feature. This feature is used to ensure that the reference device's tip is within the
boundaries of the mapping field.
If there are any questions regarding the use or performance of this product, please consult
with the local distributor or the manufacturer.
M-5276-306F
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RMT System to provide catheter tip location as
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S RMT External Reference Patch
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RMT External Reference Patch is intended for single
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S RMT Catheter
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S RMT Catheter
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RMT System patient interface unit. The
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WARNING: This is a controlled proprietary and confidential document. Verify revision is current prior to use.
AVISO: Este es un documento controlado, confidencial, y con derechos reservados. Revisar si es la revision mas actualizada.
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RMT
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DISCLAIMER OF WARRANTY AND LIMITATION OF LIABILITY
THERE IS NO EXPRESS OR IMPLIED WARRANTY, INCLUDING WITHOUT LIMITATION ANY
IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE,
ON THE PRODUCT(S) DESCRIBED HEREIN. UNDER NO CIRCUMSTANCES SHALL
BIOSENSE WEBSTER, INC., OR ITS AFFILIATED COMPANIES, BE LIABLE FOR ANY
SPECIAL, DIRECT, INCIDENTAL, CONSEQUENTIAL, OR OTHER DAMAGES OTHER THAN AS
EXPRESSLY PROVIDED BY SPECIFIC LAW.
WITHOUT LIMITING THE FOREGOING, BIOSENSE WEBSTER, INC. OR ITS AFFILIATED
COMPANIES, SHALL NOT BE LIABLE FOR ANY SPECIAL, DIRECT, INCIDENTAL,
CONSEQUENTIAL, OR OTHER DAMAGES, ARISING OUT OF THE REUSE OF ANY
PRODUCT(S) LABELED FOR SINGLE USE OR WHERE REUSE IS PROHIBITED BY
APPLICABLE LAW.
Descriptions and specifications appearing in Biosense Webster printed matter, including this
publication, are informational only and meant solely to generally describe the product at the
time of manufacture and are not made or given as a warranty of the prescribed product in
any way.
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