Device- Specific Intended Use:

The device maintains its formed shape during all sessions of radiotherapy treatment, enabling reproducibility of patient position. The device is molded at the back of the patient’s body, parts of the body or the head in order to hinder the usual range of movement occurring with non-customizable supports.

CE Marked                  FDA 510(k) pending


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

         Internal pouch fully sealed with 2 pockets: Polyurethane

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 testing was completed for patient-contacting materials in accordance with ISO 10993-5:2009,  10993-12: 2012 and ISO 10993-10: 2010.


- Declaration of Conformity 93/42/CEE Medical Device Class I    

HEAD & NECK

TOTIM cushions CERVICAL and NECK of polyurethane foam are the best solution for the head and neck treatments. It guarantees the reproducibility in the repositioning.  

BLOCKING OF THE DEVICE BY MEANS OF ASSIMILATION OF SOLID FORMS

CODES 

TOTIM IS PRODUCED IN VARIOUS SIZE AND CAN BE CUSTOMIZED TO MEET SPECIFIC DEMAND 


TOTIM DEVICE IS PACKED IN SINGLE BOXES FOR SAFE AND PROTECTED SHIPPING


TOTIM GUARANTEES COMPLETE SAFETY AGAINST LEAKAGE OF THE BICOMPONENT THANKS TO THE RESEARCH DONE BY THE R&D SECTION OF ESSEBI MEDICAL


TOTIM® TOTALLY IMMOBILE is being continuously tested  in various medical environments whenever the immobilization is needed: Opthalmology, Microsurgery, Vascular Surgery, Orthopedic Surgery, Day Surgery, etc.







ESSEBI MEDICAL SRL  - Strada Campo del Fiume 84 - 47896 Faetano -   Repubblica di San Marino - Phone +378 0549 963858 E-mail: info@totim.it PEC- totim@pec.totim.it

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