English - Calthrx Khelix Instrucciones De Uso

ENGLISH

KHELIX FIXED ELECTROPHYSIOLOGY
CATHETER
- Caution: Federal law restricts this device to sale by
or on the order of a physician.
- STERILE. Sterilized with Ethylene Oxide.
- Do not use if the package is open or damaged.
- The catheter is for single use only. Do not reuse,
reprocess or re-sterilise the devices.
- Use the device prior to the "Use By" date on the
package label.
These instructions apply to the following products:
Table 1: Product Names
Product Name Product Reference Number (REF)
Fixed
Electrophysiology Ref: [5SSF-*-*]
Catheter
Sterilization: This product and its packaging have been
sterilized with ethylene oxide gas (EO). Even though the
product is processed in compliance with all applicable
laws and regulations relating to EO exposure,
Proposition 65, a State of California voter initiative,
requires the following notice:
Warning:This product and its packaging have been
sterilized with ethylene oxide. The packaging may
expose you to ethylene oxide, a chemical known to the
State of California to cause cancer or birth defects or
other reproductive harm.
DEVICE DESCRIPTION
The Khelix Fixed Electrophysiology Catheter is
designed to facilitate electrophysiological mapping of
the heart. It consists of a catheter shaft containing an
array of platinum-iridium electrodes for stimulation and
recording. The device is available in a number of
different electrode configurations and curve types.
The Khelix Fixed Electrophysiology Catheter interfaces
with standard electrophysiological recording equipment,
such as ECG monitoring equipment, impedance based
navigational equipment and cardiac stimulation
equipment, via the Khelix Diagnostic Extension Cable
(supplied separately).
Khelix Fixed Electrophysiology Catheter is intended to
be used with the following accessory:
Table 2: Accessory for Khelix Fixed Electrophysiology
Catheter
Khelix Diagnostic Extension Cable
This accessory is available and sold separately by CathRx Ltd.
IFU0008 Rev U 2020-08
INDICATIONS
The Khelix Fixed Electrophysiology Catheter is
indicated for the electrical recording or stimulation of
endocardial structures.
INTENDED USER
Khelix Fixed Electrophysiology Catheter is used by
interventional cardiologists in electrophysiology (EP)
studies to determine the cause of an abnormal heart
rhythm, to locate the site of origin of an abnormal heart
rhythm, to decide the best treatment for an abnormal
heart rhythm, and/or to check the effectiveness of
ablation therapy.
CONTRAINDICATIONS
• The catheter has not been shown to be safe and
effective for radio frequency (RF) ablation.
• The transeptal approach is contraindicated in
patients with left atrial thrombus, myxoma, or an
inter-atrial patch or baffle.
• The use of this catheter may not be appropriate for
use in patients with prosthetic valves.
• Electrophysiology procedures are contraindicated for
patients with unstable cardiac conditions, e.g. acute
myocardial infarction, unstable angina,
hemodynamic instability.
• There is a relative contraindication for cardiac
catheterisation procedures in patients with active
systemic infection.
ADVERSE REACTIONS
A number of serious adverse reactions have been
documented for cardiac catheterisation procedures,
including cardiac tamponade, pulmonary embolism,
myocardial infarction, stroke and death.
The following additional complications associated with
cardiac catheterisation have also been reported in the
literature: vascular bleeding, local haematoma,
thrombosis, AV fistula, pseudoaneurysm,
thromboembolism, vasovagal reaction, cardiac
perforation, air embolism, arrhythmia, valvular damage,
pneumothorax and haemothorax.
DIRECTIONS FOR USE
At point of use
1. Inspect the catheter and packaging before opening.
The contents of the package are sterile unless the
package is opened or damaged.
2. If the package is opened or damaged, or if the
package was opened and the catheter unused, do
not use the catheter. Do not attempt to resterilise.
3. A detachable package label has been provided and
may be affixed to the medical record of the patient.
2