Packaging, Shelf Life, Storage And Disposal; Summary Of Safety And Clinical Performance; Reporting Obligations For Severe Incidents - Joline 11726 Instrucciones De Uso

8.7 The performance features of the device must be suitable for use in the intended intervention.
8.8 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.
8.9 Do not use the device if it appears damaged or defective.
8.10 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.
8.11 During the intervention, the heart should be monitored by means of an electrocardiogram (ECG) and other vital signs.
8.12 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.
8.13 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.
8.14 Particular caution should be taken when passing aneurysmal bulging in the vascular system and the heart in the area of application.
8.15 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.
8.16 Unintentionally opening the cutting jaws after taking the tissue samples could lead to the tissue sample being lost and result in an
embolism.
8.17 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.
9.

Packaging, shelf life, storage and disposal

The device is supplied sterile and pyrogen-free. It is individually packaged. Sterility is guaranteed as long as the packaging is not opened or
damaged.
Observe the expiration date listed on the packaging. The device must not be used after the expiry date has passed and must be disposed of.
Keep and transport the device in a cool, dark and dry place until use. Keep away from sunlight and heat.
Do not use the device if the packaging has already been opened or is damaged. If damage of any sort is identified, then the device is not
permitted to be used.
The packaging material used, which consists of paper, cardboard and plastics material, is recyclable and can be safely disposed of using the
disposal channels available. It is considered to be unproblematic waste.
The product poses no biological hazards before its use. If the device is unintentionally opened or is damaged, it can be disposed of in
accordance with hospital hygiene guidelines. In order to prevent any injuries from cuts, dispose of the device in its original protective
packaging.
The product poses potential biological hazards (e.g. microorganisms, viruses, allergens) after its use. It is therefore considered to be poten-
tially infectious waste. If the device comes into contact with pathogens which are subject to mandatory reporting during use, it is considered
to be hazardous waste and should be marked with the 'biohazard' symbol upon disposal. It must be handled and disposed of in accordance
with recognised medical procedures and in line with local, state and federal laws and regulations.
Once it has been used and therefore contaminated, immediately place the device into tear-resistant, moisture-resistant and sealed
containers at the waste-generation site and take it to a central collection point in sealed containers without being transferred or sorted.

10. Summary of safety and clinical performance

The summary of safety and clinical performance pursuant to Article 32 of Regulation (EU) 2017/745 can be retrieved from the European
database on medical devices (EUDAMED) using the Basic UDI-DI 42502039 8020000 4E as soon as it becomes available (https://ec.europa.
eu/tools/eudamed). Alternatively, the summary of safety and clinical performance can be requested using the manufacturer's contact details
on the last page of these instructions for use.

11. Reporting obligations for severe incidents

The user must immediately report all severe incidents occurring in causal relationship with the device (death of a patient, user or other person;
temporary or permanent severe deterioration in the health of a patient, user or other person; serious risk to public health) to the manufacturer
as well as the competent authority of the country in which the user is established. The unique device identifier (UDI) required for this purpose
as well as other device-related information can be found on the packaging label.
The affected product that is causally linked to a severe incident must be sent immediately to the manufacturer for the necessary inspections
and risk assessment by the manufacturer in accordance with Article 89 of Regulation (EU) 2017/745.
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