Tru-MR™ Q&A

Tru-MR™ 


Question:
Posted 27-Feb-08
 
I spent time yesterday at Coney Island Hospital. This is the account that had just purchased the MRI Laryngoscope Set and had concerns with the handles exhibiting magnetic pull. I met with Dr. Kharode, who is the director of Anesthesia. We spent time in the MRI Suite along with the director of Radiology. It does seem that there are correct in that there is a pull that is experienced when holding the laryngoscope handle. The closer that you are to the MRI Unit itself, the stronger the pull is. The handle can not stand up straight when placed approximately 12” from the unit. When held right next to the unit, it is pulled to the bottom of the scanning bed.

Is this an expected occurrence?

Elizabeth S. USA
Answer:
Posted 28-Feb-08
 

This would not seem to be a valid complaint because:

  1. From the description of the experience at Coney Island Hospital, I would say that at 12 inches from the operating MRI unit this would be an expected occurrence. Please remember that the Instructions for Use and the Cautions that are printed on the sleeve of the Tru-MR clearly state “These devices are not intended for use during the operation of an MR system for an MR Imaging procedure".
     
  2. The terminology MR Conditional is clearly defined in the report from the Shellock testing laboratory which I have attached for your easy reference.
     
    1. The term allows for a maximum deflection angle level of 45 degrees. In testing, the Tru-MR handle deflected only 14 degrees and the blade deflected 32 degrees.
       
    2. The torque measured for the handle and battery was zero and for the blade was +1.and therefore with regard to torque were deemed not to present an additional risk or hazard to a patient in the 3-Tesla MRI environment or less. In fact, for these tests torque was assessed in the center of the MR system and these devices would not be used at this position during the actual intended use.
       

In summation, there doesn’t seem to be anything wrong with the Tru-MR set at Coney Island Hospital and that they can safely use the product according to our stated Cautions and Instructions for use.

If there are still doubts in your mind please feel free to let me know.

Cynthia Yaakovi
International Marketing and Sales Manager
Truphatek International Ltd.
 


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"This is a report of our "Protocol 2002" which describes our dual stage anesthesia set-up with an introduction area outside the shielded MRI room, and an antimagnetic ventilator with monitor inside the room near the magnet. In the induction area, there is anesthesia cart with a Servo ventilator (Siemens), suction device and monitor Sirecust 1280 (Siemens)..."

 

  • The only disposable metal blade/handle combination.

 

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