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

 

1. 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:

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

The offer includes the following types:

1. 1. 1. 1. • 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)
              
            • SET OF TOT outside-in APPLICATORS – It consists of two mirror-image applicators. It is designed for use with the TOT (Trans Obturator Tape) method. The tip shape has been modified to further adapt to the anatomical structure of the pelvic floor.

 

1. 2. Product cleaning

Applicators are supplied non-sterile. Before the first and each subsequent use, the device must be cleaned and sterilized using validated methods. Before the first and each subsequent use, the instruments should be washed with warm water to remove any organic residue. Washing can be done by hand or with a plastic brush (a brush with a metal working part should not be used). Ultrasonic cleaning is recommended. Any surgical instrument made of martensitic stainless steel may discolor, corrode, or break if not handled with due care and attention.

 

1. 3. Sterilisation

It is important to sterilize applicators together with instruments made of martensitic stainless steel, designated B (designation according to EN ISO 7153-1 Surgical instruments – Metallic materials – Part 1: Stainless steel). Before first use and each subsequent use, instruments should be cleaned and then sterilized using the methods listed below. We recommend sterilizing instruments using moist heat (STEAM). If this type of sterilization is not possible, dry heat sterilization is the recommended method. During the sterilization process, follow the sterilization principles specified in the relevant standards, requirements, and national regulations. During the process, instruments should not be exposed to temperatures above 200°C (392°F).

Instruments made of martensitic stainless steel should only be sterilized with instruments made of the same material. Sterilizing applicators with instruments made of a different material may result in discoloration and corrosion of the instrument. After sterilization, instruments should be inspected for cracks, scratches, or discoloration. If any of the above damage is found on the product, it should not be used and should be disposed of. If the product shows no changes or damage, it can be used as a surgical instrument. Non-sterile instruments should not be used.

 

1. 4. Packaging

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