KLINIKA 105880900N KliniMark CLIP Owner’s Manual
- July 9, 2024
- KLINIKA
Table of Contents
KLINIKA 105880900N KliniMark CLIP
Important notice
Improper handling and use can result in hazards and damage. We therefore ask
you to read through these instructions for use and follow them exactly. Keep
them close at hand at all times. To avoid personal injury and damage to
property, please also observe the safety instructions. If you have any
questions about the contents of these instructions for use or the use of the
product, please contact us.
Your KLINIKA team.
Scope
These instructions for use apply to the following products:
- Article: KliniMark CLIP
- Article number: REF: 105880900N
Product description
The KliniMark CLIP is a sterile, disposable product consisting of a puncture cannula (18G, 12 cm long) and a preloaded, non-absorbable Nitinol clip marker. The clip marker has an omega shape with dimensions of 5.9 x 2.1 mm and a diameter of 4.5 mm. The cannula has space markings (1 cm) for measuring the penetration depth and a bevelled tip for insertion into the tissue. The product is intended for long-term use.
Operating principle
The preloaded, non-magnetic Nitinol CLIP is placed in the area to be marked
through a cannula (18G). By removing the spacer, the CLIP is pushed into the
tissue. Nitinol is clearly visibly on ultrasound and x-ray images. Under an
imaging procedure, such as mammography or ultrasound, the target area is
punctured with the cannula. The marker is placed by removing the spacer on the
stylet and pushing the stylet forward. The position of the marker is
documented. Then the cannula is removed. It is helpful to mark tumours or
other areas in this way so that they can be relocated or observed (e.g. in
neoadjuvant therapy). Due to its shape (omega V), the KliniMark Clip is easy
to relocate threedimensionally. Information about the material The Clip is
made from Nitinol (nickel-titanium alloy), the cannula from steel.
Intended use
The KliniMark CLIP is a medical device used for diagnosis, treatment and
monitoring in medical procedures. KliniMark CLIP is used for tissue marking in
breast tissue and lymph nodes: Before or after chemotherapy or radiotherapy to
mark the location of a biopsy removal or a removed tumour, in the case of
unclear findings.
Indication
The markers are used, for example, in lesions before or after chemotherapy or
radiotherapy, or at the site of a biopsy removal or a removed tumour.
KliniMark CLIP can also be used for preoperative tissue marking.
Contra-indications
- Nitinol is a nickel-titanium alloy and should therefore, in the case of a known, pronounced nickel allergy, only be used after a doctor‘s recommendation.
- The marker must not be used on the heart, central nervous system or central circulatory system.
- The cannula is not MRI capable and must not be placed under MRI. The Clip is made of Nitinol, Nitinol is MR-compatible, there is no data available for this product.
Designated patient group
Adults. The product must not be used on children, pregnant women or
breastfeeding women.
Designated users
Medical staff.
Designated environment for use
Medical treatment room, surgery.
Use:
- Before use, it must be checked that the packaging is closed and not damaged. Please check the expiry date.
- Open the packaging at the tear-off flap with the foil side facing up. Remove the foil and take out the product aseptically.
- Disinfect the area of the procedure and, if necessary, perform local anaesthesia.
- Remove the protective cap from the needle.
- Under an imaging procedure, such as mammography or ultrasound, puncture the target area with the cannula.
- Place the marker by removing the spacer on the stylet and pushing the stylet forward.
- The CLIP unscrews on the opposite side to the blue mark on the cannula holder.
- Document the position of the marker. Then remove the cannula.
- Treat the wound.
- After treatment, the cannula must be disposed of properly in a suitable cannula container.
Storage and storage life
The product must not be used if the packaging is open, damaged or damp. Store
in a dry place, away from direct light and heat. Do not store or use the
product at temperatures below +5 °C. Sterility is guaranteed by the complete
packaging. The KliniMark CLIP has a storage life of three years in clean,
cool, dry and dark conditions.
Warning notes
- The KliniMark CLIP should only be used by qualified physicians who have sufficient experience and expertise in the percutaneous marking of soft tissue.
- This product was manufactured expressly for single use. It must not be resterilised or recycled after a single application. Resterilisation or recycling may result in material defects of the product or the medical device becoming no longer safe for use. Resterilisation may lead to serious infections, cross-contamination and injury to the patient. The preloaded Nitinol marker in the cannula is non-absorbable and intended for single use only. KLINIKA Medical GmbH rejects any responsibility in the case of resterilisation and reuse of even one of the product components.
- The marker must not be used on the heart, central nervous system or central circulatory system.
- Only the CLIP may remain in the tissue.
- The cannula is not MRI capable and must not be placed under MRI.
- Please only use the KliniMark CLIP before the expiry date and with undamaged, unopened packaging. Otherwise the sterility of the product cannot be guaranteed.
- Side effects
- None known
- Residual risks
- If the surface of the Clip becomes damaged, this may lead to allergic reactions (nickel).
- In rare cases, the Clip may migrate in the tissue and thus fail to mark the desired area.
- Crosslinking of the Clip may occur which can reduce visibility in the ultrasound image.
- The cannula may become hot in MRI and cause burns.
- If the product is not applied properly, this can result in injury, hematomas and pain for the patient.
- Bleeding may occur if a blood vessel is damaged by the cannula or Clip.
- Reuse may lead to infections and cross-contamination.
SSCP
A summary report of the safety and clinical performance pursuant to EU
2017/745, Art. 32 on implantable products (SSCP) will be made available on the
website www.klinika-medical.de.
Product information
- Design: KliniMark CLIP, sterile steel cannula with Nitinol marker
- Diameter: (Gauge) 18
- Length of cannula: (mm) 120
- Cannula material: Steel
- Size of Clip: (mm) 4.9 x 2.1
- Diameter of Clip: (mm) 4.5
- Clip material: Nitinol
- PU: 2 x 5
- Article no. 105880900N
Manufacturer’s contact details
KLINIKA Medical GmbH
Am Dornbusch 29, 61250 Usingen
Germany
Tel.: +49 6081 9139-0
info@klinika-medical.de
Feedback
In the event of serious incidents occurring in connection with this medical
product, please report these to us as well as to the responsible authorities.
Feedback on the instructions for use
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