Instructions for Use
1. Intended Purpose
BolusCare is a polymer-based, individually moldable two-component bolus material for external use on intact skin in external beam radiotherapy. It is used to influence the surface dose and to compensate for anatomical contours. It is to be applied exclusively by qualified medical professionals.
2. Medical Indication and Context of Use
BolusCare is used in particular for superficial target volumes. The material can be adapted directly to complex anatomical contours in order to achieve close skin contact and reduce air gaps. The actual geometry and dosimetric properties of the bolus must be taken into account in the patient's individual radiotherapy treatment planning.
3. Users and Qualification
The product is intended for qualified medical professionals, in particular specialists in radiation oncology, medical physics, and radiotherapy technology (RTTs). Use takes place in accordance with clinical specifications under the responsibility of the treatment team.
4. Product Description
BolusCare consists of component A and component B. After the components are combined and sufficiently mixed, the reaction leading to form-stabilization begins. Once form-stabilization is complete, the patient-specific bolus retains its shape while remaining flexible and elastic; it does not become hard or rigid. Reuse on the same patient for further treatment fractions requires that the bolus still fit appropriately and be in flawless condition.
5. Preparation
Before use, product identity, expiry date, and packaging integrity must be checked. The components are processed at room temperature; disposable gloves are recommended. Skin and the working environment should be clean and dry. The amount of material required is determined in advance based on the intended anatomical coverage. BolusCare may only be applied to intact skin.
6. Mixing and Immediate Shaping
Components A and B are preferably combined in a 1:1 ratio and briefly but thoroughly mixed with the fingers, so that they are distributed across the material to be shaped and brought into contact with one another. A fully uniform color is not in itself a stopping criterion; however, visible unmixed portions of material must not remain. It is recommended not to knead longer than necessary, but to begin shaping on the patient immediately, and to use the fingers rather than the whole palm wherever possible, in order to limit additional heat transfer. The available shaping time depends, among other things, on the temperature of the material, the ambient temperature, and heat input. The material is shaped directly onto the desired anatomy while the reaction is beginning, achieving skin contact that is as close and wrinkle-free as possible. Form-stabilization must be complete before irradiation: the material must reliably retain its adapted shape while remaining flexible. The term "curing," as used in test reports for the complete chemical reaction of test samples, is distinct from this clinical shaping phase and does not mean that the finished product becomes hard or rigid; no general minimum clinical time can be derived from it. Deviations from the recommended mixing ratio can change the time to form-stabilization; BolusCare is to be used only within the application parameters approved by the manufacturer.
7. Irradiation Planning and Position Control
The bolus thickness need not be identical everywhere, provided that the actual geometry is correctly captured and taken into account dosimetrically. The form-stabilized material must be represented in the planning imaging in accordance with the clinical workflow, or accounted for using a suitable, validated method. Position, skin contact, and fit must be checked before every fraction. In the event of relevant changes to anatomy, material shape, or position, a renewed medical physics assessment and, if necessary, an adjustment of the plan is required.
8. Special Application Notes
Excessive pressure and traction on sensitive skin areas must be avoided during shaping. If pain, skin irritation, unexpected reactions, or noticeable changes in the material occur, use must be discontinued and medically assessed. Use on open wounds, mucous membranes, or non-intact skin is not covered by these instructions for use.
9. Hygiene and Patient-Specific Use
The components are intended for the single manufacture of one patient-specific bolus. The form-stable, still-flexible bolus may be used exclusively on the same patient for further treatment sessions, provided that hygiene, fit, material condition, and clinical suitability allow it. Use on other patients is excluded. Unused material residue must be disposed of. Patient-specific assignment follows the institution's internal data-protection and hygiene requirements.
10. Cleaning and Reprocessing
If needed, the form-stabilized bolus may be cleaned with water for continued use on the same patient, provided that the clinical hygiene concept allows it. It must then be fully dried and checked for damage, deformation, and residue. There is no validated procedure for sterilization or reprocessing for use on other patients. Autoclaving, cleaning with boiling water, and non-approved disinfectants must not be used as routine clinical reprocessing. In case of hygienic doubt or damage, a new bolus must be made.
11. Risks and Precautions
Possible risks include skin irritation or intolerance, as well as dosimetric deviations caused by air gaps, incorrect positioning, unaccounted-for thickness, or altered material properties. A damaged, insufficiently form-stable, or ill-fitting bolus must not be used for irradiation. Patient-specific treatment planning and quality assurance take precedence.
12. Storage and Shelf Life
Unopened components must be stored at temperatures between 15 °C and 25 °C and protected from direct sunlight and moisture. Refrigerator storage is not part of the specified storage conditions. The expiry date on the packaging must be observed; products with damaged packaging or an expired shelf life must not be used.
13. Disposal and Incidents
Material residue and products that are no longer usable must be disposed of in accordance with local and institutional regulations. Serious incidents related to the product must be reported to the manufacturer and to the competent authority in accordance with applicable regulations.
14. Manufacturer Information
BolusCare GmbH (a German limited liability entrepreneurial company)
Gewerbepark Grünewald 9
58540 Meinerzhagen
Germany