1. Intended Purpose
BolusCare is a tissue-equivalent, polymer-based bolus material intended for external use in external beam radiotherapy. The product is used for the targeted adjustment of surface dose and for compensating anatomical contours in order to achieve the most precise and reproducible dose distribution possible. Use is restricted to trained medical professionals.
2. Medical Indication and Context of Use
The product is primarily used for superficial target volumes where adaptation of the dose to the skin surface is required. Due to its flexible structure, BolusCare allows direct adaptation to the patient’s individual anatomy, enabling uniform contact without significant air gaps. This contributes to the reliable delivery of the planned dose distribution in radiotherapy.
3. Users and Qualification
The use of BolusCare is intended exclusively for professional users. These include, in particular, radiation oncologists, medical physicists, and radiation therapy technologists (RTTs) who are familiar with the requirements and procedures of radiotherapy. Use must only take place within clinical processes and in accordance with the respective treatment plan.
4. Product Description
BolusCare consists of a two-component system comprising component A and component B. After combining the two components, a chemical reaction occurs that leads to curing of the material within a few minutes. The resulting material is elastic, dimensionally stable, and exhibits tissue-like properties. These characteristics allow the material to closely conform to the skin surface.
5. Application
It is recommended to wear disposable gloves and to process components A and B at room temperature. A clean and well-structured working environment contributes to ensuring consistently high application quality.
6. Mixing and Application
The two components A and B are mixed in a 1:1 ratio until a homogeneous mass without visible streaks is achieved. The mixing ratio must be maintained to ensure stability and to avoid irregularities during irradiation. After mixing begins, there is a limited working time during which the material should be directly molded on the patient. Curing occurs within a few minutes. The material is applied in such a way that the most complete possible contact with the skin is achieved. A precisely defined or uniform thickness is not strictly required, as adjustments can be taken into account during treatment planning.
7. Special Instructions for Use
Due to its material properties, BolusCare can be flexibly adapted to different anatomical conditions. Based on available biocompatibility testing, the product may also be used on more sensitive skin areas. Nevertheless, use should always be evaluated within the clinical context and with consideration of individual patient factors.
8. Hygiene and Single Use
BolusCare is designed as a single-use product per patient and is intended for use on one patient only. Reuse or reprocessing for use on other patients is not intended. After use, any remaining material must be disposed of.
9. Cleaning, Disinfection and Sterilization
The product is not intended for reprocessing within the meaning of MDR. For reuse on the same patient or for non-clinical purposes such as training or demonstration, the cured material may be cleaned under running water. Cleaning with hot or boiling water is also possible. In addition, commonly used disinfectants or surface wipes suitable for clinical environments may be used.
The material is temperature resistant up to approximately 200 °C. Sterilization in an autoclave is generally possible; however, changes in material properties cannot be ruled out. It is therefore recommended to use temperatures below the maximum limit. No validated reprocessing method for clinical use is available; therefore, reuse on other patients is excluded.
10. Risks and Side Effects
As with all medical applications, individual reactions may occur. These may include, in particular, skin irritation or intolerance. Improper use may also affect the planned dose distribution. Users are therefore advised to perform the application carefully and in accordance with clinical guidelines.
11. Storage and Shelf Life
BolusCare must be stored at temperatures between 15 °C and 25 °C. The product must be protected from direct sunlight and moisture. The shelf-life information on the packaging must be observed. Products with damaged packaging must not be used.
12. Disposal
Disposal of the product must be carried out in accordance with applicable local regulations for medical materials. Reuse is excluded.
13. Vigilance and Feedback
All serious incidents, unexpected events, or product-related issues must be reported immediately to the manufacturer and the relevant authorities. Feedback from clinical use contributes to the continuous improvement of the product.
14. Manufacturer Information
BolusCare UG (haftungsbeschränkt)
Gewerbepark Grünewald 9
58540 Meinerzhagen
Germany