Edwards D200F7 Bedienungsanleitung

English . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1
Français . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4
Deutsch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8
Español . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12
Italiano . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .16
Nederlands . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .19
Dansk . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .23
Svenska . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .27
Ελληνικά . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .31

English

Swan-Ganz Pacing-TD Catheter
D200F7, D205F7
D205F7 is not available in EU
The devices described herein may not all be licensed in accordance with
Canadian law or approved for sale in your specific region.
Carefully read these instructions for use, which address the
warnings, precautions, and residual risks for this medical device.
CAUTION: This Product Contains Natural Rubber Latex Which May
Cause Allergic Reactions.
For Single Use Only
For figures, see Figure 1 on page 94 through Figure 7 on page 99.
1.0 Description
The pacing-TD catheter is available in two models: the standard Model
D200F7 and the Model D205F7. For additional clinical flexibility in the
smaller anatomy, the electrodes have been moved distally on the Model
D205F7. The pacing TD catheter has three atrial and two ventricular
electrodes for atrial and ventricular pacing and atrioventricular (A-V)
sequential pacing.
The Swan-Ganz pacing catheters are recommended for use in situ for up to 72
hours.
As part of the insertion procedure this product is used for ECG detection
during placement, but is not intended for ECG monitoring.
Device performance, including functional characteristics, have been verified
in a comprehensive series of testing to support the safety and performance of
the device for its intended use when used in accordance with the established
Instructions For Use.
The intravascular catheter is inserted through the central vein to connect to
the right side of the heart and advance towards the pulmonary artery. Route
of insertion can be internal jugular vein, antecubital or brachial vein. The
cardiac structures in contact are the right atria, right ventricle, and
pulmonary artery as well as the circulatory system.
The Swan-Ganz pacing-TD catheter provides temporary electrical cardiac
stimulation to facilitate return to and/or continuance of normal cardiac
rhythm.
Edwards, Edwards Lifesciences, the stylized E logo, CO-Set, CO-Set+, Swan,
and Swan-Ganz are trademarks of Edwards Lifesciences Corporation. All
other trademarks are the property of their respective owners.
DIRECTORY
Português . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .35
Česky . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .38
Magyar . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .42
Polski . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .46
Slovensky . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .50
Norsk . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .53
Suomi . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .57
Български . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .60
Română . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .64
This device has not yet been tested in the pediatric population or in pregnant
or lactating women.
2.0 Intended Use/Purpose
Swan-Ganz pacing-TD catheters are pulmonary artery catheters intended to
serve as diagnostic and therapeutic tools for short-term use in the central
circulatory system for patients who require intracardiac hemodynamic
monitoring, temporary cardiac pacing, blood sampling and infusing
solutions. Swan-Ganz pacing-TD catheters also provide electrocardiographic
detection during catheter placement. When used with a compatible
monitoring platform and accessories Swan-Ganz pacing-TD catheters offer a
comprehensive hemodynamic profile to help clinicians assess cardiovascular
function and guide treatment decisions.
3.0 Indications
The Swan-Ganz pacing-TD catheters are indicated for use for temporary,
atrial, ventricular, or A-V sequential cardiac pacing of adult surgical and/or
critically ill patients. This includes, but is not limited to, patients with
arrythmias, acute myocardial infarction, cardiac surgery, and coronary
angiography.
In addition, these catheters are indicated for use in hemodynamic monitoring
of patients experiencing medical conditions such as, but not limited to, post-
major surgical recovery, trauma, sepsis, burns, pulmonary disease,
pulmonary failure, stroke, and cardiac disease including heart failure.
4.0 Contraindications
Endocardial pacing catheters are contraindicated in patients with a
mechanical valve. If the pacing lead is placed through a mechanical valve, the
valve leaflet will be held permanently open and result in significant
permanent valve regurgitation.
Relative contraindications may include patients with either recurrent sepsis,
or with hypercoagulable state where the catheter could serve as a focus for
septic or bland thrombus formation.
These products contain metallic components. Do NOT use in a Magnetic
Resonance (MR) environment.
5.0 Warnings
Air should never be used for balloon inflation in any situation where
it may enter the arterial circulation, e.g. in all pediatric patients and
adults with suspected right to left intracardiac intrapulmonary
shunts.
Bacteria-filtered carbon dioxide is the recommended inflation
medium because of its rapid absorption into the blood in the event
of balloon rupture within the circulation. Carbon dioxide diffuses
through the latex balloon, diminishing the balloon's flow-directed
capability after 2 to 3 minutes of inflation.
Do not leave the catheter in a permanent wedge position.
Furthermore, avoid lengthy balloon inflation while the catheter is
1
Eesti . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .68
Lietuvių . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .72
Latviešu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .75
Türkçe . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .79
Русский . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .82
Srpski . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .87
Hrvatski . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .90
in a wedge position; this occlusive maneuver may result in
pulmonary infarction.
This device is designed, intended and distributed for SINGLE USE
ONLY. DO NOT RE-STERILIZE OR REUSE this device. There are no data
to support the sterility, non-pyrogenicity and functionality of the
device after reprocessing. Such action could lead to illness or an
adverse event as the device may not function as originally intended.
Do not modify or alter the product in any way. Alteration or
modification may affect patient/operator safety or product
performance.
Cleaning and resterilization will damage the integrity of the latex
balloon. Damage may not be obvious during routine inspection.
As part of the insertion procedure this product is used for ECG
detection during placement, but is not intended for ECG monitoring.
Use of the catheter on patients with tricuspid tissue-based valve
prothesis can increase regurgitation because when the device lays
across the tissue valve leaflets it may cause regurgitation. It should
be noted that the lead should be placed into one of the commissures
so not to touch the leaflet and cause regurgitation.
The pacing-TD catheter is not recommended for use in pacemaker-
dependent patients. No absolute contraindications for the use of
flow directed pulmonary artery catheters exist. However, a patient
with a left bundle branch block may develop a right bundle branch
block during catheter insertion, resulting in complete heart block.
In such patients, temporary pacing modes should be immediately
available.
Electrocardiographic monitoring during catheter passage is
encouraged and is particularly important in the presence of either
of the following conditions:
• Complete left bundle branch block, in which the risk of complete
heart block is somewhat increased.
• Wolff-Parkinson-White syndrome and Ebstein's malformation, in
which the risk of tachyarrhythmias is present.
6.0 Precautions
Clinicians using the device should be familiar with the device and
understand its applications prior to use.
When handling indwelling leads, the terminal pins or exposed
metal (on the product) are not to be touched nor be allowed to
contact electrically conductive or wet surfaces.
Failure of a balloon flotation catheter to enter the right ventricle or
pulmonary artery is rare, but may occur in patients with an
enlarged right atrium or ventricle particularly if the cardiac output
is low or in the presence of tricuspid or pulmonic incompetence or
pulmonary hypertension. Deep inspiration by the patient during
advancement may also facilitate passage.