Indications: The Pleura-safe® safety pleural puncture kit is indicated for the following thoracentesis procedures: fluid and
air accumulations in the pleural cavity that are diagnostically non-specific and require therapeutic thoracentesis only for
Contraindications: use of the Pleura-safe® safety pleural puncture kit is not recommended for:
• diseases associated with blood coagulation disorders
• uncooperative patients
• introduction of hardening or chemotherapy compounds based on ether, absolute alcohol or tumour-inhibiting substances, or other known and not indicated thoracenteses.
User information and instructions for use (see diagram):
- Locate puncture site by standard method (e.g. percussion, x-ray or ultrasound).
- Prepare site using standard precautions and under sterile conditions.
- After the puncture site has been prepared and anaesthecised:
- Remove needle cap from catheter (A) with previously inserted safety puncture needle (F)
- Perform the puncture of the chest wall. Pressure on the obturator causes the colour indicator (red, H) to move
in the cannula window. This ensures that the spring mechanism in the cannula is operating correctly.
- After insertion of the cannula tip into the pleural cavity, retract the blunt obturator and the colour indicator (red) to their original position. If the colour indicator (red, H) does not retract (does not move), the puncture procedure must be stopped.
- Now one of two methods for aspiration of fluid or air from the pleural cavity can be selected – a: with the needle, b: with the catheter:
a. After positioning the system, connect the syringe (D) included with the kit to the safety valve (G) of the safety puncture needle (F) by pressing and rotating it. Then aspirate the fluid or air by pulling out the syringe plunger.
b. To remove greater volumes of fluid and to use the catheter for aspiration, withdraw the safety puncture needle (F) from the catheter (A). Leave the catheter in the pleural cavity. Once the needle has been completely removed, the self-closing safety valve (I) closes. If it does not close, the puncture procedure must be stopped. The stopcock (B) of the catheter must be closed after removal of the safety puncture needle (F). Connect the 60-ml syringe (D) and the bag (E) to the automatic three-way valve (C). After the catheter has been positioned, aspirate the fluid with the syringe and press to empty the syringe into the bag (E). This procedure can be repeated several times without any adjustments to the system.
- Remove the drainage catheter from the patient.
- If the instructions for use are ignored, medical complications may result. Therefore, read the instructions carefully.
- Thoracentesis should only be conducted by persons with sufficient experience and qualifications in pleural puncture. These persons should also be able to recognise possible complications such as haemorrhage and the occurrence of a pneumothorax.
- Do not bring the catheter into contact with a 100% acetone solution.
- The kit is not suitable for use with sclerotising or chemotherapeutic substances that contain ether, absolute alcohol or antineoplastic substances.
- The safety puncture needle (F) is already fully inserted into the catheter.
- The puncture procedure should be stopped if the colour indicator (red, H) in the catheter window does not ove or if its position does not change during the procedure.
- The kit must not be used with instruments and/or accessories from other manufacturers.
- It must not be used for continuous thoracic drainage and must be removed immediately on completion of the horacentesis procedure.
- All Luer Lock connections must be tight before using the safety pleural puncture kit and must be visually hecked during use.
- Although a blunt obturator and a colour indicator are used to prevent penetration injuries, the standard recautions for inserting a needle must be used.
- Always visually monitor that the kit is operating correctly during use. In case of doubt that the kit is operating orrectly the puncture procedure must be stopped.
- 1 catheter (8 Ch) with integrated safety puncture needle and automatic three-way valve
- 1 60 ml Luer Lock syringe
- 1 2000 ml drainage bag with drain
- During the puncture procedure do not rely on listening for a click but always monitor the color indicator.
- When removing the needle after the puncture procedure check the position of the catheter.
- Do not insert the needle repeatedly.
- It is intended for single use with one patient and must not be resterilised. If the product is resterilised, its function may be impaired; therefore this is not permitted.