Instructions for Use
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 as well as the compensation of anatomical contours, in order to enable the most precise and reproducible dose distribution possible. The product is to be used exclusively by trained medical professionals.
2. Medical Indication and Context of Use
The product is used in particular for superficial target volumes where an adjustment of the dose to the skin surface is required. Due to its flexible structure, BolusCare enables direct conformation to the patient's individual anatomy, achieving uniform contact without relevant air gaps. This contributes to the reliable implementation of the planned dose distribution within the context of radiotherapy.
3. Users and Qualification
The use of BolusCare is intended exclusively for professional users. This includes in particular radiation oncologists, medical physicists, and radiation therapy technologists (RTTs) who are familiar with the requirements and procedures of radiotherapy. Use may only take place within the framework of clinical processes and with due consideration of the respective treatment plan.
4. Product Description
BolusCare consists of a two-component system, comprising component A and component B. After the two components are combined, a chemical reaction takes place that results in curing of the material within a few minutes. The resulting material is elastic, dimensionally stable, and exhibits tissue-like properties. These properties allow the material to conform closely 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 structured working environment helps to ensure consistently high quality of application.
6. Mixing and Application
The two components A and B are mixed together in a ratio of 1:1 until a homogeneous mass free of visible streaks is obtained. The mixing ratio must be observed in order to ensure stability and to avoid irregularities during irradiation. Once mixing has begun, a limited working time is available, within which the material should be modeled directly 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. An exactly defined or uniform thickness is not strictly required, as the adaptation can be taken into account during treatment planning.
7. Special Notes on Application
Due to its material properties, BolusCare can be flexibly adapted to different anatomical conditions. Based on available biocompatibility testing, the product may also be applied to more sensitive skin areas. Nevertheless, use should always be assessed 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 a single patient only. Reuse or reprocessing for multiple use on other patients is not intended. Remaining material residues are to be disposed of after use.
9. Cleaning, Disinfection and Sterilization
The product is not intended for reprocessing within the meaning of the MDR. For reuse on the patient for whom the product was originally used, and for non-clinical applications such as training or demonstration purposes, the cured material may be cleaned under running water. Cleaning with hot or boiling water is likewise possible. In addition, commercially available disinfectants or surface wipes, as commonly used in the clinical environment, may be used.
The material exhibits temperature resistance up to approximately 200 °C. Sterilization in an autoclave is generally possible; however, it cannot be excluded that material properties may change. It is therefore recommended to use temperatures below the maximum load limit. A validated reprocessing procedure for clinical use is not available; reuse on further patients is therefore excluded.
10. Risks and Side Effects
As with all medical applications, individual reactions may occur. These include, in particular, possible skin irritation or intolerance. Furthermore, improper application may affect the planned dose distribution. Users are therefore required to carry out the application carefully in accordance with clinical specifications.
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
The product must be disposed of in accordance with the applicable local regulations for medical materials. Reuse is excluded.
13. Vigilance and Reporting
All serious incidents, unexpected events, or product problems must be reported immediately to the manufacturer and to the competent authorities. Feedback from clinical use contributes to the continuous improvement of the product.
14. Manufacturer Information
BolusCare UG (haftungsbeschränkt) (a German limited liability entrepreneurial company)
Gewerbepark Grünewald 9
58540 Meinerzhagen
Germany