ML20137A378

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Requests Listed Addl Info Re 830113 Application for License to Demonstrate Lixiscope.Description of Bldg in Which Facilities Located Should Be Provided.Response within 30 Days Requested
ML20137A378
Person / Time
Issue date: 03/28/1984
From: Holt B
NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION III)
To: Pleunneke H
BIOTEC BIOMEDICAL TECHNOLOGY, INC. (BIOTEC, INC.)
Shared Package
ML20137A259 List:
References
76259, NUDOCS 8508210396
Download: ML20137A378 (2)


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%g/Vf Biotec Biomedical Tech., Inc.

ATTN: Harold Pleunneke, Jr.

1184 Hill Road, North Pickerington, OH 43147 Gentlemen:

We are in receipt of your application dated January 13, 1983 (received February 2, 1984) for an NRC License to demonstrate the Lixiscope, a portable imaging device containing 500 millicuries of iodine-125. Additional information is needed in support of your request. Please respond to the following:

1. Describe the type of building in which your facilities on Hill Road are located.
2. Since you are requesting authorization to use the Model LSM82-209 Lixiscope, it appears that you will be demonstrating the device to medical personnel, however, this is not addressed in your application. Please clarify.
3. Please inform us if your demonstrat'ons of the Lixiscope will include training end-users (e.g., physicians) on radiation safety related procedures associated with the possession and use of the device.
4. If you will be instructing end-users as described above:

a) Describe the training and experience that Messrs. Pluenneke and Gilmartin have obtained to qualify them to instruct potential users of the Lixiscope.

Include an outline of any additional training received, the duration of the training, their experience using and instructing others on the use of the device, and the name of their instructor (s). Please be specific in your response.

In addition, submit a statement from the instructor (s) certifying Messrs.

Pluenneke and Gilmartin's qualifications to train end-users and describing the method used to determine their competency, b) Describe the training that will be given to end-users, including the duration of the training and the method that will be used to determine corpetency.

5. Describe the types of locations where you will be demonstrating the Lixiscope, e.g., doctors' offices, hospitals, conventions, etc. Please be as specific as possible since these locations will be specified on your license.

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6. What procedures will you implement to maintain accountability of all sealed sources received by Biotec Biomedical Tech., Inc. and transferred to Lixi, Inc. for disposal?
7. Describe your means for preventing unauthorized access to the Lixiscope when the device is in storage at temporary job sites.
8. What provisions have you made for obtaining access to a properly calibrated survey meter in the event of suspected source leakage?
9. Outline the duties and responsiblities of your radiation protection officer.

We will continue the review of your application upon receipt of this information.

Please reply in duplicate within 30 days and reference Control No. 76259.

Sincerely, B. J. Holt Materials Licensing Section RIII I

Holt /bm ([p1h 4

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