TOTIM have been proven to reduce preparation time, especially for difficult set-ups
Reducing rates of misalignments reduces the number of repeated port films, saving therapists and physicians valuable time
The device is used in a healthcare facility / hospital. The device is intended to be used on adult and pediatric patients.
TOTIM® is a fully sealed polyurethane foam cushion covered with microfiber polyester tissue for patient positioning and immobilization during simulation, planning and radiation treatment. The cushion shapes and molds around the patient after activation of the internal components. It maintains its formed shape during all sessions of radiotherapy treatment, enabling reproducibility of patient position.
Features & Clinical Benefits
Sealed and ready for use - Limits movement and enables reproducibility of the patient position - Conform to shape easily during stiffening phase - Disposable, easy to sanitize markable and radio transparent - Can be formed and indexed to positioning devices and other rigid supports - Pediatric options available
Indications for Use:
TOTIM® Patient Cushions Immobilization System is indicated to position and/or immobilize and/or repositioning forms both adult and pediatric patients undergoing radiation therapy of the body, head, brain, neck, cervical, arm, limb, hand and leg including Stereotactic Radiosurgery (SRS), Stereotactic Radiotherapy (SRT), Surface Guided Radiation Therapy (SGRT), and electron, photon and proton treatments. The device is also used during image acquisition, including Computed Tomography (CT) and Magnetic Resonance (MR) Imaging, to support treatment planning.
Technical Characteristics:
Cushion with external cover in microfiber comfortable and absorbent water repellent non-woven material, markable, washable/easily sanitized, temperature controlled exothermic reaction, the short window of time required for solidification allows for the correct modeling of the external cover in microfiber polyester tissue fully sealed.
its formed shape during all sessions of radiotherapy treatment, enabling reproducibility of patient position.
TOTIM® is a polyurethane foam immobilization system using fully sealed bag/cushion.
The device can be attached to the treatment or simulation couch, extension, or overlay along with other optional positioning and immobilization devices and accessories.
Materials: Cushion in Microfiber Polyester / PU (fully sealed) and internal pouch (fully sealed) with inside the two reagents ready to be mixed.
Non-clinical testing was completed to confirm that TOTIM is safe and effective device.
A scientific rationale was used to address RF heating, magnetically induced torque, and magnetically induced displacement force.
The TOTIM® device was tested with ASTM F2119-07 (Reapproved 2013) Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants (Materials), TOTIM is MR Safe.
Proton Test Water Equivalent Thickness (WET) Values:
to verify that the product to not negatively impact a proton team when measured orthogonally through the permissible radiation area.
Conclusion: the product tested do not perturb or impact the proton beam in a way that cannot be accounted for in the proton treatment planning process.
- The devices are intended for limited contact duration (<24 hours) for surface devices (skin).
Biocompatibility: ISO 10993-5:2009, 10993-12: 2012 and ISO 10993-10: 2010.
