1. Product characteristics
2. Product cleaning
3. Sterilisation
4. Packaging

 

1. Product characteristics

Needle applicators are reusable accessories used in surgical treatment of stress incontinence in women taking into account the division into methods applied. Each tool is used to create a tunnel in patient’s body in order to properly implant the urological tape. It’s well designed construction enables to easily and safely fix the implant on them and properly insert through patient’s anatomical structures according to TVT or TOT method.

Each of the applicators is composed of a handle and a curved portion with a profiled tip – the entire instrument is made of stainless steel. The two parts are welded together. The corresponding curvature enables to pass an urological tape through the patient’s anatomical structures depending on the surgical procedure. The tip is in a form of a needle with an eye, where the urological tape is fixed. The needle is finished so as to cut through the muscle tissues without the risk of damaging internal organs, and to place the tape in a position to gain a positive treatment outcome.

The applicators are:

• non sterile
• reusable
• made of stainless steel which meets the requirements of standards concerning surgical instruments

The offer includes the following types:

• TVT APPLICATOR – applicator used in TVT method (Tension-free Vaginal Tape)
  
• TOT APPLICATOR – applicator used in TOT method (Trans Obturator Tape)
  
• SET OF TOT APPLICATORS – consists of two applicators which are mirror images of each other; intended for use in TOT method (Trans Obturator Tape)
  

 

2. Product cleaning

The needle applicators are delivered for sale unsterile. Before using them for the first time and before every subsequent usage of the product, it has to be subject to cleaning and sterilisation with the use of validated methods. Before using it for the first and other time, clean the tools with warm water in order to remove any organic residues. The tools shall be washed manually or with the use of a brush made of plastics (do not use the brush with the working part made of metal). It is recommended to wash the tools with the use of ultrasounds. Every surgical instrument is made of martensitic stainless steel; it may decolour, corrode or break if it is not treated with due care and diligence.

 

3. Sterilisation

It is essential for the applicators to be sterilised together with tools made of martensitic stainless steel marked with B symbol (marking according to EN ISO 7153-1:2000 Surgical tools – Metal materials – Part 1: Stainless steel standard). Before using them for the first and another time, the tools shall be subject to sterilisation with the use of methods mentioned below. The instruments shall be sterilised in a validated cycle. STEAM sterilisation is recommended ,or if this method is not possible dry heat sterilisation is permissible. During the sterilisation process, the rules of sterilisation specified in appropriate standards, requirements and legal regulations have to be observed. During the process, the tools cannot be subject to temperatures above 200°C (392°F).

Tools made of martensitic stainless steel shall be sterilised only with tools made of the same raw material. In case of sterilising applicators, sterilisation with tools made of different raw material may cause decolouration or corrosion of tools. After carrying out the sterilisation process, the tools have to be checked for the presence of cracks, scratches or decolourisation. In case of stating any of the above mentioned damages, the product cannot be used and it has to be utilised. If the product does not have any changes or damages, it can be used as a surgical tool. Unsterile tools cannot be used.

 

4. Packaging

Each applicator is heat-sealed in packaging made of polyethylene film with a label.