Johnson & Johnson Biosense Webster QDOT MICRO Bidirektionaler Navigationskatheter Gebrauchsanweisung Seite 6

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QDOT MICRO™ Bi-Directional Navigation Catheter
 Intended for Export
 STERILE. Sterilized using ethylene oxide.
 For single use only.
 Do not resterilize.
 Do not use if the package is open or damaged.
Device Description
The Biosense Webster QDOT MICRO™ Bi-Directional Catheter is a steerable
multi-electrode luminal catheter with a deflectable tip designed to facilitate
electrophysiological mapping of the heart and to transmit radiofrequency (RF)
energy to the catheter tip electrode for ablation purposes. The catheter shaft
measures 7.5 F with 8 F ring electrodes. For ablation, the catheter is used in
conjunction with a compatible RF generator and a dispersive pad (indifferent
electrode). The catheter has force-sensing technology that provides a real-time
measurement of contact force between the catheter tip and the heart wall.
The catheter has a high-torque shaft with a bi-directional deflectable tip section
containing an array of electrodes which includes a 3.5 mm tip dome. All of the
electrodes may be used for recording and stimulation purposes. The tip
electrode serves to deliver RF energy from the generator to the desired ablation
site. The tip electrode and ring electrodes are made from noble metals. The
catheter incorporates six thermocouple temperature sensors and three ECG
electrodes that are embedded in the 3.5 mm tip electrode. A Rocker Lever is
used to deflect the tip. The high-torque shaft also allows the plane of the curved
tip to be rotated to facilitate accurate positioning of the catheter tip at the desired
site. Additionally, a variety of curve types are available in symmetric or
asymmetric combinations, providing two 180° opposed, single-planed curves.
Five curve configurations designated "DD", "FF", "JJ", "DF", and "FJ" are
available.
At the proximal end of the catheter, a saline input port with a standard Luer fitting
terminates from the open lumen. This saline port serves to permit the injection of
normal saline to irrigate the tip electrode. During ablation, heparinized normal
saline is passed through the internal lumen of the catheter and through the tip
electrode, to irrigate and cool the ablation site as well as the electrode tip.
A compatible irrigation pump is used to control the saline irrigation. The catheter
interfaces with standard recording equipment and a compatible RF generator via
accessory extension cables with the appropriate connectors.
This catheter features a location sensor embedded in the tip section that
transmits location and contact force information to the CARTO™ 3 System. An
appropriate reference device is required for location reference position purposes.
For information on using the catheter in mapping procedures and for information
on appropriate reference devices, refer to the user manual for the CARTO™ 3
Navigtion System. For further description of the operation of the irrigation pump,
the generator, and the CARTO™ 3 Naviation System, refer to the applicable
instructions for use.
Indications for Use
The Biosense Webster QDOT MICRO™ Bi-Directional Navigation Catheter and
related accessory devices are indicated for catheter-based cardiac
electrophysiological mapping (stimulating and recording) and, when used in
conjunction with a compatible radiofrequency generator for cardiac ablation.
The Biosense Webster QDOT MICRO™ Bi-Directional Navigation Catheter
provides a real-time measurement of temperature and contact force between the
catheter tip and heart wall, as well as location information when used with
CARTO™ 3 System.
Contraindications
Do not use this catheter:
1. If the patient has had a ventriculotomy or atriotomy within the preceding eight
weeks because the recent surgery may increase the risk of perforation.
2. In patients with a myxoma or an intracardiac thrombus as the catheter could
precipitate an embolus.
3. In patients with prosthetic valves as the catheter may damage the prosthesis.
4. In the coronary arterial vasculature due to risk of damage to the coronary
arterial vasculature.
5. In patients with an active systemic infection because this may increase the
risk of cardiac infection.
6. Via the transseptal approach in a patient with an interatrial baffle or patch
because the opening could persist and produce an iatrogenic atrial shunt.
7. Via the retrograde trans-aortic approach in patients who have had aortic
valve replacement.
8. With a long sheath or short introducer < 8.5 F in order to avoid damage to the
catheter shaft.
Warnings and Precautions
1. Do not use excessive force to advance or withdraw the catheter when
resistance is encountered during catheter manipulation through the sheath.
2. Do not manually pre-shape the distal shaft of the catheter by applying
external forces intended to bend or affect the intended shape or curve of the
catheter.
3. Prior to use, the catheter must be warmed up as specified in the Directions
for Use section of this document. If the catheter has not reached a steady
state condition, there is potential for a zero-offset drift to occur which could
result in an inaccurate contact force reading.
4. Always zero the contact force reading following insertion into the patient or
when moving the catheter from one chamber of the heart to another.
Ensure the catheter is not in contact with heart tissue prior to zeroing. Refer
to the user manual for your CARTO™ 3 System for instructions on how to
zero the contact force reading.
5. The contact force reading might become inaccurate if the contact force
sensor (located between the first and second ring electrode) comes into
close proximity with a ferrous material, such as the braided shaft of another
catheter. If extreme fluctuations in force are observed, ensure the catheter's
contact force sensor is not in close proximity with another catheter's shaft,
check zero on the catheter and, if necessary, remove and inspect the
catheter. The contact force reading is for information only and is not
intended to replace standard handling precautions.
6. To ensure proper operation of the contact force sensor, the tip electrode
and all four ring electrodes must protrude from the distal tip of the guiding
sheath.
7. When applying high lateral force during mapping and RF application, the
user should monitor the contact force dashboard and vector display on the
CARTO™ 3 System screen to ensure that contact force measurements
remain within the accurate range. Refer to the Error Messages and Alerts
section of the CARTO™ 3 System user manual for system-related alert
messages and indications related to inaccurate force readings.
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