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ΝephroPatch (External puncture closure)
1. Intended Use/Indications
ΝephroPatch is an elastic strip for closing the puncture site after puncturing. The adhesive Strip Το ΝephroPatch is intended for haemodialysis applications. The external closure strip is used as a substitute for manual or mechanical compression of puncture sites by the patient or nursing staff. ΝephroPatch is a single use aid for use in chronic haemodialysis.
ΝephroPatch is a self-adhesive used for hemodialysis applications. This outer stopper is intended for manual and / or mechanical compression of the puncture points by the patient or their respective healthcare personnel.
ΝephroPatch should be used as an adjuvant only for single use in chronic hemodialysis.
2. PRODUCT DESCRIPTION
2.1 Package Contents
Each sterile package contains 2 (two) disposable external closure strips for use on one patient during one treatment.
2.2 Sterilization
ΝephroPatch is sterilized in its sterile package with ethylene oxide.
3. DESCRIPTION OF USE
3.1 Conditions for use
ΝephroPatch may only be used upon instructions of the physician providing treatment. The user must be instructed in the use of ΝephroPatchPatient and / or relatives (if applicable, living –in or external nursing staff) must be trained in the manual compression of bleeding puncture sites.
Step-by-step approach:
1. Perform dialysis in the usual manner.
2. Preparation: expected adhesion sites must be free of grease and moisture, clean if necessary with an alcohol solution and allow to dry before applying the holding strips. Pre-cleaning with surgical soap is recommended for patients with allergic reactions to degreasing agents. Disinfectants based on polyvidone iodine, disinfectants with high alcohol content reduce the adhesive strength of the holding strips.
3. Use: Remove the ΝephroPatch from the package. Remove the silicone paper from the adhesive layer. Do not touch the adhesive side of ΝephroPatch with bare fingers (this reduces the adhesion to the skin).
4. Centering the lens: Centrally position the pressure element (lens) over the puncture channel.
5. Application / fastening: Tape holding strips to both sides of the skin, taking into account individual physical circumstances. Holding strips must not overlap.
6. Removing the cannula: If required, position your fingertip on the rear side of the lens while applying light pressure. Quickly remove the fistula needle and, if necessary, leave your fingertip there briefly until no more blood escapes. Use a swab to wipe away drops of blood escaping from the fistula needle.
7. Result: no further blood flow from the puncture site. Initial monitoring of the functionality is required.
8. Removing ΝephroPatch: Μετά από 4 (ή καλύτερα 8-14 ώρες) αφαιρέστε το ΝephroPatch 8. Removing ΝephroPatch: Remove ΝephroPatch after 4, preferably after 8-14 hours, in the same way as a plaster. In extremely rare cases earlier removal of ΝephroPatch can loosen the blood clot in the puncture channel. In these cases, conventional pressure is recommended to stop bleeding by. ΝephroPatch να προκαλέσει εκροή σταγόνων αίματος στο κανάλι τρυπήματος. Συνιστάται να διακόπτεται η αιμορραγία μέσω άσκησης συμβατικής πίεσης.
9. Precautionary measures: In the case that ΝephroPatch becomes loose from the skin prematurely, it is recommended that you remove ΝephroPatch and stop the bleeding by applying pressure in the conventional manner.
Side effects
1. Allergic reactions can occur in patients who do not tolerate skin adhesives or sterilizing agents.
Contra-indications
1. ΝephroPatch may not be used as a circular bandage.
2. . Discontinue use of ΝephroPatch on patients with known intolerance to it. (e.g. allergic reactions to skin adhesives and sterilization agents).
Furthermore, do not use ΝephroPatch:
3. On thin, fragile skin
4. In the case of a newly placed or revised shunt
5. For closing conventional skin injuries
3.4 Warnings
1. Disinfectants based on polividone iodine reduce the adhesive properties of the holding strips.
2. Do not touch the adhesive side of ΝephroPatch with your fingers.
3. Holding strips shall not overlap.
4. Initial monitoring of the functionality.
5. In extremely rare cases, premature removal of ΝephroPatch can loosen the blood clot in the puncture channel.
6. Do not use ΝephroPatch beyond the expiry date (see label). The use of ΝephroPatch beyond the expiry date can reduce its effectiveness and it may not fulfil its function.
7. ΝephroPatch is intended only for single use on one patient during one treatment. Do not reuse or sterilize ΝephroPatch. Re-sterilization or reuse of ΝephroPatch ΝephroPatch can reduce its effectiveness and prevent it from fulfilling its function. Among other things this may lead to, increased risk of infection, inadequate haemostasis or skin adhesion.
3.5 Storage
1. Only use undamaged original packages.
2. Store ΝephroPatch in a cool (0˚C-30˚C) and dry place.
