Totim cushion positioning system in radiotherapy

Certified CE and FDA K 190894 Class II

ESSEBI MEDICAL SRL TOTIM®

Strada Campo del Fiume 84

47896 Faetano, RSM

C.O.E. SM26889

TOTIM® Patient Cushions Positioning system Radiotherapy

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

Totim cushion positioning immobilization system in radiotherapy

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® Cushion form by activation of internal component to then shape and mold around the patient.
Does not require vacuum or water activation process to form rigid cushion

NO AIR OR MOISTURE ACTIVATION - NO PPE USE

Totim cushion positioning system in radiotherapy

Each and every TOTIM® cushion guarantees the highest quality repositioning solutions

TOTIM® is a polyurethane foam positioning 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). The cushion is MR Safe, is manufactured of non-magnetic materials

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.

TOTIM CONFORMITY

PUBLICATIONS TOTIM