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CARTO™ 3 System Interface Cable Caution: Federal law (U.S.A.) restricts this device to sale by or on the order of a licensed healthcare practitioner. NON-STERILE
INDICATIONS FOR USE This cable provides a means to connect a compatible RF generator to the CARTO™ 3 System. This cable may be reused subject to the cleaning and disinfecting restrictions in this document. Table 1 – Cables Cable Name CARTO™ 3 System Interface Cable
Purpose Connects a compatible RF generator to the CARTO™ 3 System.
Catalog Numbers D129704
D129707
Manufacturing Numbers D-1297-04
D-1297-07
CONTRAINDICATIONS There are no known contraindications for this cable.
PATIENT TARGET GROUP This cable is targeted at patients who have been diagnosed with cardiac arrythmias and are undergoing an electrophysiology procedure.
INTENDED USERS The intended users of this cable are appropriately trained personnel in a fully equipped electrophysiological laboratory.
CLINICAL BENEFIT This cable provides a means to connect a compatible RF generator to the CARTO™ 3 System.
DIRECTIONS FOR USE 1. Do not use the cable after the use-by date on the product label. 2. Before using or reusing the cable, visually inspect it for damage such as crushed or elongated sections, cuts, kinks, or nicks. If the cable is damaged, do not use the cable and dispose of it per the “DISPOSAL” section below. 3. Connect the cable to the proper equipment by referring to the connector designations at each end of the cable. 4. Follow the instructions in the “CLEANING AND DISINFECTION,” “STORAGE,” and “DISPOSAL” sections below.
CLEANING AND DISINFECTION This cable meets the requirements of the ANSI/AAMI EC53-2013. Table 2 – Cleaning and Disinfection Warnings and Precautions
1. Ensure proper cable connection by referring to the connector designations at each end of the cable. 2. Do not use the cable after the use-by date on the product label. 3. Do not immerse the cable connectors in liquid. Do not wipe the cable connectors with liquid. The presence of liquid inside the connectors may result in adverse effects, including improper functioning (such as noisy signals or signal degradation) or arcing of electricity between the connector pins, which can lead to patient injury. 4. Do not expose the cable to organic solvents because they may damage the cable. 5. Patient or operator injury may result from improper handling, improper connection, or improper use of the cable. 6. To prevent damage, store the cable in a clean and secure area. 7. If a break occurs in the cable wire or if the cable becomes otherwise electrically discontinuous, arcing may occur in the patient-return or active circuit and may burn the patient or create a fire. 8. Automated cleaning of the cable is not recommended because fluid may enter the connectors and leave moisture or residue in or on the connectors. Resulting adverse effects may include improper functioning (such as noisy signals or signal degradation) or arcing of electricity between the connector pins, which can lead to patient injury.
Limitations on Cleaning and Disinfection
The cable is designed for a maximum of 20 cleaning and disinfection cycles. After 20 cleaning and disinfection cycles, dispose of the cable per the “Disposal” section below. Clean the cable after each use.
Initial Treatment at Point of Use
There are no requirements for initial treatment at point of use.
Containment and Transportation
Place the cable in a clean biohazard bag after use for subsequent cleaning and disinfection. Clean and disinfect the cable as soon as it is reasonably practical after use.
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English Preparation before Cleaning
Visually inspect the cable for any damage such as crushed or elongated sections, cuts, kinks, or nicks. If damage is observed, do not use the cable and dispose of it per the “Disposal” section below.
Cleaning: Automated
Automated cleaning of the cable is not recommended because fluid may enter the connectors and leave moisture or residue in or on the connectors. Resulting adverse effects may include improper functioning (such as noisy signals or signal degradation) or arcing of electricity between the connector pins, which can lead to patient injury.
Cleaning: Manual
1. Wear sterile gloves while handling the cable. 2. Using a wipe*, use a twisting motion to wipe the entire surface of the cable, but not the cable connectors, to remove soil. Pay particular attention to complex cable features (such as non-smooth areas, joints, and crevices). 3. Using another wipe*, use a twisting motion to thoroughly wipe the entire surface of the cable to remove soil. 4. Visually inspect the cable to ensure there is no visible soil. Additional wipes may be used to remove any visible soil. 5. Leave the cable in ambient conditions until it is visibly dry. 6. When the cable is dry, visually inspect the entire surface of the cable in adequate lighting to ensure complete removal of visible soil. *Recommended Wipes: CaviWipes™ or any other wipes with the chemical composition indicated in the table below may be used. Chemical Composition
Disinfection
% of Chemical
Isopropanol
17.2%
Diisobutylphenoxyethoxyethyldimethylbenzyl ammonium chloride
0.28%
1. Wear sterile gloves while handling the cable. 2. Ensure manual cleaning (see the “Cleaning: Manual” instructions in this table) is performed before disinfection. 3. Using a wipe*, use a twisting motion to thoroughly wipe the entire surface of the cable. Pay particular attention to complex cable features (such as non-smooth areas, joints, and crevices). 4. Allow the surface of the cable to remain visibly wet for 3 minutes at room temperature (approximately 68°F/20°C). 5. Additional wipes may be used to ensure that the cable remains visibly wet for 3 minutes. 6. Leave the cable in ambient conditions until it is visibly dry. 7. Visually inspect the entire surface of the cable in adequate lighting to ensure the cable is visibly clean. *Recommended Wipes: CaviWipes™ or any other wipes with the chemical composition indicated in the table below may be used. Chemical Composition
% of Chemical
Isopropanol
17.2%
Diisobutylphenoxyethoxyethyldimethylbenzyl ammonium chloride
0.28%
Drying
Drying is performed as part of the disinfection process (see the “Disinfection” instructions in this table).
Maintenance, Inspection, and Testing
Before packaging, visually inspect the cable. If visible soil is present, repeat the “Cleaning: Manual” and “Disinfection” instructions in this table. If there is evidence of damage, do not use the cable and dispose of it per the “Disposal” section below.
Packaging
If the cable is stored after cleaning and disinfection, place it in a breathable pouch that is approved by the FDA and/or by local authorities. Coil the cable into a loop when placing it into the pouch. Do not fold the cable because doing so may break the cable. Use a pouch large enough to prevent stress to the pouch seams and to prevent excessive bending of the cable. A pouch size of 19 cm x 33 cm (7. 5" x 13") or larger is recommended. For storage conditions, refer to the “Storage” section below.
The instructions provided above have been validated by the medical device manufacturer as being capable of preparing a medical device for reuse. It remains the responsibility of the processor to ensure that the processing as performed (using equipment, materials, and personnel in the processing facility) achieves the desired result. This requires validation and routine monitoring of the process. Likewise, any deviation by the processor from the instructions provided should be properly evaluated for effectiveness and potential adverse consequences.
STORAGE Refer to the product label for recommended storage conditions.
DISPOSAL Recycle components, or dispose of the product and its residual elements or waste items in accordance with local laws and regulations.
REPORTING INCIDENTS Per regulation 2017/745/EU on medical devices, if this device is used in the European Union (or in a country with an identical regime) and a serious incident occurs during the use of this device or as a result of use of this device, report the incident to the manufacturer and/or its authorized representative and to your national authority.
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ADVERSE REACTIONS A number of adverse reactions have been documented for electrophysiology procedures including: heart block, pulmonary vein stenosis, esophageal fistula and/or injury, stroke (cerebrovascular accident), other arrhythmias (outside diagnosis), life threatening arrhythmias, myocardial infarction, cardiac perforation, pericardial effusion, cardiac tamponade, thrombosis, embolism, pulmonary embolism, air embolism, valvular damage, phrenic nerve injury, vagal nerve injury, pericarditis, coronary artery stenosis, vessel perforation (peripheral and/or central), soft tissue injury, persistent atrial communication, device related infection, embolization of components, device entrapment, surgical intervention (additional), skin burns, and localized skin reaction. The following complications associated with cardiac catheterization have also been reported in the literature: major bleed, hematoma, reaction to medications, allergic reaction, vascular access complication, damage to vasculature, implanted device interactions, renal artery stenosis, pneumothorax, ST segment changes, fluid overload, urinary catheter complications, hypotension, sepsis, wound infection, respiratory failure, heart injury, renal injury, heart failure, cardiac arrest and death.
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 APPLICABLE 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, Inc. printed matter, including this publication, are informational only and meant solely to generally describe the product(s) at the time of manufacture and are not made or given as a warranty of the prescribed product(s) in any way.
ELECTRONIC INSTRUCTIONS FOR USE This document is available at www.e-ifu.com.
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Biosense Webster, Inc. 31 Technology Drive, Suite 200 Irvine, California 92618 USA Tel: +1-909-839-8500 Tel: +1-800-729-9010 Fax: +1-909-468-2905 www.biosensewebster.com Biosense Webster A Division of Johnson & Johnson Medical NV/SA Leonardo da Vincilaan 15 1831 Diegem, Belgium Tel: +32 2 7463 401 Fax: +32 2 7463 403
BIOSENSE WEBSTER, the Biosense Webster logo, and CARTO are trademarks of Biosense Webster, Inc. The third-party trademarks used herein are trademarks of their respective owners. Patent information is available at www.biosensewebster.com/virtualpatentmarking.
Revised: 2021-07 © Biosense Webster, Inc. 2000-2021
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