Special Temporary Authority application - Applicant Name
Name of Applicant:
Agilent Technologies, Inc.
Special Temporary Authority application - Best Contact
First Name:
Robert
Last Name:
Leichner
Phone Number:
650-485-8720
Title:
Project Scientist
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:
2001-02-15 18:30:58.57
Signature of Applicant (Authorized person filing form):
Robert Craig Leichner
Title of Applicant (if any):
Project Scientist
Special Temporary Authority application - Explanation
Please explain in the area below why an STA is necessary:
Agilent Technologies, Inc. (?Agilent?) hereby requests Special Temporary Authorization (?STA?), pursuant to Section 5.61 of the Commission?s rules, from March 1, 2001, to September 1, 2001, to operate a prototype low-power transmitter (the ?Prototype?), as part of a clinical trial. The Prototype units will be used to test the clinical value of a medical device capable of transmitting digitally encoded pulse oximetry information from a monitoring unit on a home-bound patient to a receiver connected to a modem in the patient?s residence. The Prototype units are similar to those that are commercially available for the transmission of clinical parameters other than pulse oximetry. The receiver and modem combination is commercially available and is authorized under Part 15 and registered under Part 68. Agilent?s request for STA is supported by good cause. As a leading manufacturer of medical equipment, Agilent seeks to provide prototype equipment fora clinical trial on treatment alternatives for patients with a chronic, life-threatening disease. Given the implications for developing technologies that will improve the health and welfare of patients with a difficult-to-treat disease, the public interest will be served by grant of the requested STA. Agilent is seeking STA because the scope and duration of its proposed operation does not warrant filing an application for permanent experimental authorization under Part 5 of the Commission?s rules. Further, the test Agilent proposes would be conducted in a residential environment and equipment manufacturers are not authorized under Section 2.803(e)(1)(iii) of the Commission?s rules to operate in residential environments without seeking formal authority under Part 5.
Special Temporary Authority application - Information
Callsign:
WB9XLX
Class of Station:
MO
Nature of Service:
Experimental
Special Temporary Authority application - Initial values - Purpose of Operation
Please explain the purpose of operation:
Agilent proposes to operate the Prototype as described herein and in the associated application for STA. Agilent seeks to provide Prototype units for a clinical study of the clinical value of electronically communicating pulse oximetry regarding home-bound, chronically ill patients to caregivers in other locations. The goal of the study is to assess the ability of patients to use the system without assistance, as well as the usefulness of the information made available to the caregiver. Because of the special conditions pertaining to the medical treatment of patients in their own homes, this invaluable information cannot effectively be obtained using laboratory testing or in-hospital trials. The transmitter contains a commercially available transmitter module manufactured by RF Monolithics, Inc. (model HX2000). This module is designed for unlicensed operation under Section 15.241 of the Commission?s rules at 916.5 MHz. The transmitter module output is coupled to a tuned slot antenna fabricated as part of the device main printed circuit assembly. An attenuator on the main printed circuit assembly limits RF emissions to below the legally allowable limits for this class of operation. Around 50 transmitters will be installed to test the feasibility of the Prototype. Agilent?s contractors will place the units in operation at the homes of selected patients. The Prototype units may only send information over the public airwaves and then through telephone modems to specially configured computers. Ultimately, any product developed following this trial would be authorized as a Part 15 transmitter, and would comply with all applicable Part 15 emission limits.
Special Temporary Authority application - Manufacturer
Equipment 1 Experimental
Yes
Equipment 1 Manufacturer
Agilent Technologies, Inc.
Equipment 1 Model Number
M3814A
Equipment 1 No. Of Units
55
Special Temporary Authority application - Purpose of Operation
Please explain the purpose of operation:
Clinical study of the clinical value of electronically communicating pulse oximetry using prototype equipment in homes of patients.
Special Temporary Authority application - Requested Period of Operation