0114-EX-ST-2009

Filing overview

Special Temporary Authority application - Address

Attention:

John Rymkiewicz

City:

St. Paul

E-Mail Address:

john.rymkiewicz@yahoo.com

State:

MN

Street Address:

4100 Hamline Ave N

Zip Code:

55112

Special Temporary Authority application - Applicant Name

Name of Applicant:

Guidant Corp. the wholly owned subsidiary of Boston Scientific Corporation

Special Temporary Authority application - Best Contact

First Name:

John

Last Name:

Rymkiewicz

Phone Number:

651-582-6869

Title:

Fellow Electrical Engineer

Special Temporary Authority application - Certification

Applicant certification

Neither the applicant nor any other party to the application is subject to a denial of Federal benefits that includes FCC benefits pursuant to Section 5301 of the Anti-Drug Abuse Act of 1988, 21 U.S.C. Section 862, because of a conviction for possession or distribution of a controlled substance. The applicant hereby waives any claim to the use of any particular frequency or electromagnetic spectrum as against the regulatory power of the United States because of the prvious use of the same, whether by license or otherwise, and requests authorization in accordance with this application. (See Section 304 of the Communications Act of 1934, as amended.) The applicant acknowledges that all statements made in this application and attached exhibits are considered material representations, and that all the exhibits part hereof and are incorporated herein as if set out in full in this application; undersigned certifies that all statements in this application are true, complete and correct to the best of his/her knowledge and belief and are made in good faith. Applicant certifies that construction of the station would NOT be an action which is likely to have a significant environmental effect. See the Commission's Rules, 47 CFR1.1301-1.1319.

Date:

2009-03-18 00:00:00.0

Signature of Applicant (Authorized person filing form):

John Rymkiewicz

Title of Applicant (if any):

Fellow Electrical Engineer

Special Temporary Authority application - Explanation

Please explain in the area below why an STA is necessary:

The reason is to maintain FCC compliance when performing at site on customer premises

Special Temporary Authority application - Information

Callsign:

WD9XTO

Class of Station:

MO

Nature of Service:

Experimental

Special Temporary Authority application - Initial values - Purpose of Operation

Please explain the purpose of operation:

Boston Scientific is in the evaluation phase of a product development effort for a patient health home monitoring equipment that utilizes the Medical Implant Communications Systems (MICS) band as regulated by FCC Part 95 of the FCC code. Current Boston Scientific products utilize the ISM band. There is desire by Boston Scientific to move away from the ISM band into the MICS band that was specially designed to support implanted medical devices. The products in development will provide a daily monitoring of the patients implanted medical device. These implanted devices are pacemakers, automatic implanted cardio defibrillators, and heart failure devices. The specific objective of this test is to evaluate the Boston Scientific system being developed within the home environment such that the challenges unique to a home environment well understood. This will enable Boston Scientific to ensure that our patients receive the best possible solution for home monitoring in turn leading to better quality of health care. The system being proposed for use in evaluating the MICS band consists of a prototype of the implanted medical device and prototype of the external home monitoring equipment. This box is an external software, and RF equivalent of what will ultimately be implemented as a medical device. The prototype of the implanted device is not a mechanical equivalent in size due to the need to build the unit out of commercially available parts prior the large investment required to make the parts out of custom built parts. The system has been tested in an industrial location as much as practical and all indications are that the test in the residential area will be successful. However, due to the nature of the product being part of the health care system, it is important that tests be conducted in the variety of residential setting.

Special Temporary Authority application - Manufacturer

Equipment 1 Experimental

Yes

Equipment 1 Manufacturer

Guidant/Boston Scientific

Equipment 1 Model Number

G3

Equipment 1 No. Of Units

10

Equipment 2 Experimental

Yes

Equipment 2 Manufacturer

Guidant/Boston Scientific Corp

Equipment 2 Model Number

Fast RF St.R002

Equipment 2 No. Of Units

10

Special Temporary Authority application - Purpose of Operation

Please explain the purpose of operation:

Evaluation of a product development effort for patient health home monitoring equipment. Boston Scientific is in the evaluation phase of a product development effort for a patient health home monitoring equipment that utilizes the Medical Implant Communications Systems (MICS) band as regulated by FCC Part 95 of the FCC code. Current Boston Scientific products utilize the ISM band. There is desire by Boston Scientific to move away from the ISM band into the MICS band that was specially designed to support implanted medical devices. The products in development will provide a daily monitoring of the patients implanted medical device. These implanted devices are pacemakers, automatic implanted cardio defibrillators, and heart failure devices. The specific objective of this test is to evaluate the Boston Scientific system being developed within the home environment such that the challenges unique to a home environment well understood. This will enable Boston Scientific to ensure that our patients receive the best possible solution for home monitoring in turn leading to better quality of health care. The system being proposed for use in evaluating the MICS band consists of a prototype of the implanted medical device and prototype of the external home monitoring equipment. This box is an external software, and RF equivalent of what will ultimately be implemented as a medical device. The prototype of the implanted device is not a mechanical equivalent in size due to the need to build the unit out of commercially available parts prior the large investment required to make the parts out of custom built parts. The system has been tested in an industrial location as much as practical and all indications are that the test in the residential area will be successful. However, due to the nature of the product being part of the health care system, it is important that tests be conducted in the variety of residential setting.

Special Temporary Authority application - Requested Period of Operation

Operation End Date:

10/01/2009

Operation Start Date:

04/01/2009

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