Warnings And Precautions - Calthrx Khelix Instrucciones De Uso

ENGLISH
Start of Procedure
1. Remove the catheter from its sterile packaging using
aseptic technique. Place device on a sterile working
area.
2. Inspect the catheter for any damages. Do not use
the catheter if kinked.
3. Inspect the catheter for damage to the insulation or
connectors. The connector contacts must be dry.
4. Test all functions of the catheter.
5. Connect the extension cable by inserting the distal
end of the extension cable into the socket located at
the proximal end of the catheter. Prior to connection,
ensure the key (raised ridges) on the cable
connector are aligned with the key slots inside the
connector socket of the catheter.
The catheter must only be used with Khelix
Diagnostic Extension Cable.
During Procedure
1. Vascular access is created with a minimum 6 French
haemostasis introducer sheath to accommodate the
catheter.
2. Advance the catheter through the vascular access
site into the desired intracardiac position using
fluoroscopic and ECG guidance.
End of Procedure
1. Remove the catheter from the patient.
2. Disconnect extension cable from catheter by
gripping the extension cable pin head where the
arrows are printed on the pin head and pull
outwards.
3. Dispose the catheter according to standard hospital
procedure for biologically contaminated material.
STORAGE
Store in a cool, dry place (minimum temperature: -10°C
[14°F]; maximum temperature: 55°C [131°F]; relative
humidity: 85% ± 5%).
DISPOSAL
Dispose device according to standard hospital
procedure for biologically contaminated material.

WARNINGS AND PRECAUTIONS

• Do not attempt to operate the catheter prior to
completely reading and understanding these
Instructions for Use.
• Careful catheter manipulation must be performed in
order to avoid cardiac damage, perforation, or
tamponade. Catheter advancement and placement
should be done under fluoroscopic guidance.
• Do not use excessive force to advance or withdraw
the catheter when resistance is encountered.
IFU0008 Rev U 2020-08
• The catheter should only be used by clinicians
trained in cardiac electrophysiology procedures, in a
fully equipped electrophysiology laboratory.
• The catheter is for single use only. Do not reuse,
reprocess or resterilise the device. Reuse,
reprocessing or resterilisation may compromise the
structural integrity of the devices and/or lead to
device failure. For example, detachment of small
components like tip, ring electrode dislocates, unable
to sense signals in heart. Risk of cross
contamination and poor catheter handling.
• Use of anti-coagulants should be considered for left-
side procedures to reduce risk of thrombi formation
and stroke.
• Cardiac catheterisation procedures present the
potential for significant X-ray exposure. Exposure to
X-rays can result in acute radiation injury as well as
increased risk for somatic and genetic effects in both
patients and electrophysiology laboratory staff, due
to the X-ray beam intensity and duration of the
fluoroscopic imaging. Steps should be taken to
minimise X-ray exposure.
• In view of the potential for X-ray exposure and the
associated risks, careful consideration must be given
for the use of the device in pregnant women.
• Care should be taken when introducing,
manipulating and withdrawing the catheter to avoid
cardiac trauma and possible damage to the catheter
which may result in detachment of catheter
components.
• The catheter electrodes, the catheter and extension
cable connectors, and the dispersive electrode,
should not contact other conductive parts and earth.
• To avoid char formation on the Khelix Fixed
Electrophysiology Catheter electrodes, do not apply
RF energy when an ablation catheter is in contact
with one or more of the catheter electrodes.
• Do not expose the catheter to organic solvents such
as alcohol.
• Do not immerse the catheter handle or any cable
connector in fluid as electrical performance could be
affected.
• The catheter is MR unsafe. Do not use the catheter
system near MRI equipment, as movement or
heating of the catheter may occur, and the image or
display may become distorted.
• The catheter is a type CF applied part. Any
equipment used in connection with this device and
its accessories must be defibrillation-proof type CF
and meet IEC 60601-1 and IEC 60601-1-2.
• The catheter, together with its accessories, has been
tested to allow connection with stimulation
equipment with a rated current of 25mA, and a rated
voltage of 27V.
• If the catheter becomes kinked, dispose of it.
Replace with an undamaged device.
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