Use - Joline 11726 Instrucciones De Uso

12. Use

12.1 Open the packaging and place the device on a sterile operating table.
WARNING: Observe sterile procedures at all times when removing sterile components from the packaging and when
handling the device. The device must only be prepared and used in a sterile environment.
12.2 Check that the device is working properly by opening and closing the cutting jaws (Figures 2.1 and 2.2).
WARNING: Do not use the device if it appears damaged or defective.
12.3 If necessary, the already pre-bent shaft of the device can be further modified manually. To do this, hold the distal end between your
thumb and index finger (Figure 3.1). Run your fingers along the shaft towards the tip and bend it to the desired angle while doing so
(Figures 3.2 and 3.3). Check that the device is working properly after the modification.
WARNING: Do not bend the pre-bent shaft excessively during manual modification. This may cause damage to the core
wire and the device to lose function as a result.
Figure 3.1
12.4 Before inserting the device for the first time, wipe it with a compress moistened with sterile physiological saline solution (NaCl 0.9%).
12.5 Insert the device through the 6 Fr. sheath, which has already been positioned.
DANGER: During the intervention, the heart should be monitored by means of an electrocardiogram (ECG) and other vital
signs.
DANGER: During the intervention, suitable diagnostic imaging, e.g. a C-arm for diagnostic radiography, should be used
at all times to check whether the device is in the correct position.
WARNING: If unusual resistance is encountered during the intervention, the intervention must be discontinued. Before
the intervention can be continued, the cause of the resistance must be identified. If the cause of the resistance cannot be
identified, the device must be removed and the intervention must be discontinued.
WARNING: Particular caution should be taken when passing aneurysmal bulging in the vascular system and the heart in
the area of application.
12.6 In addition to visually observing the device, the course of the bend of the pre-bent shaft can also be identified on the basis of the
moulded arrow on the grip, which acts as a bend indicator (Figure 1, ref. 4). The pre-bent shaft is oriented by rotating the grip. In this
process, the shaft of the device is held between the fingers.
12.7 When the tip of the device is positioned in the ventricle, gently push the closed cutting jaws forward until you feel resistance. Confirm
that the device is correctly positioned and directed using suitable diagnostic imaging, e.g. a C-arm for diagnostic radiography.
12.8 Pull the device back by approx. 1 cm and open the cutting jaws. To do this, gently pull back the thumb ring of the grip and slide away
from the index finger and middle finger (Figure 2.1).
12.9 Push the opened cutting jaws forward as far as the planned sampling point. Release the tension on the thumb ring, gently exert
pressure on the thumb ring, close the cutting jaws (Figure 2.2), and thereby extract the tissue sample.
WARNING: Always operate the device with caution. The device may be damaged if excessive force is exerted on the grip.
It is not necessary to exert excessive force to cut through the tissue. The cutting jaws are sharp and cut with relatively
little pressure.
12.10 With the cutting jaws closed, pull the device back through the sheath and pull out of the sheath.
WARNING: Unintentionally opening the cutting jaws could lead to the tissue sample being lost and result in an embolism.
12.11 Open the cutting jaws to remove the tissue sample. To do this, gently pull back the thumb ring of the grip (Figure 2.1).
12.12 After removing the tissue sample and before the device is reinserted, clean the device in a sterile physiological saline solution (NaCl
0.9%) by repeatedly opening and closing the cutting jaws.
WARNING: Clean the device thoroughly in a sterile physiological saline solution (NaCl 0.9%) during the intervention after
each tissue sample is taken in order to remove residual tissue and to prevent a possible subsequent embolism.
12.13 Once you have finished using the device, dispose of it in accordance with Section 9.
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Figure 3.2 Figure 3.3