JIAXTP1Integrated Physiological Monitoring System

Mini Mitter Co. Inc.

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Application Details

Equipment Class: DXX - Part 15 Low Power Communication Device Transmitter
Date of Grant: Dec 09, 2003
Application Purpose: Original Equipment
Date of Application: Dec 09, 2003
Equipment Note: Integrated Physiological Monitoring System
Frequency Range: 40.68000000 - 40.68000000
Company: Mini Mitter Co. Inc.
Country: United States

Documents & Files

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Document Text

Text extracted from the exhibit documents filed with the FCC. Open a document above to read the original.

Users Manual

Mini Mitter Company, Inc. Bend, OR USA VitalSense ® Integrated Physiological Monitoring System Instruction Manual This document is Mini Mitter Part Number 910-0500-Preliminary C Copyright © 2003 Mini Mitter Company, Inc. VitalSense ® is a registered trademark of Mini Mitter Company, Inc. PRELIM IN AR Y MINI MITTER COMPANY, INC. WARRANTY POLICY 1. WARRANTY: Mini Mitter warrants that upon delivery the goods sold hereunder will be free of defects in materials and workmanship, and such goods will substantially conform to the specifications furnished by the Seller, and to any drawings or specifications furnished to the Buyer by Mini Mitter if approved by Mini Mitter. a) Commencement of Warranty – The warranty period begins on the date of delivery. b) Duration of Warranty – The goods sold hereunder are warranted for a period of twelve months, except PDT-4000 and PDT-4000HR, which are warranted for two years. c) Third Party Product Warranty – Third party products purchased by Buyer through Mini Mitter are covered by the manufacturer’s warranty and ARE NOT COVERED BY THE MINI MITTER WARRANTY. d) Place of Repair or Replacement. Buyer must return the defective or nonconforming goods upon request to Mini Mitter at 20300 Empire Ave- nue, Building B-3; Bend, OR 97701, not later than 15 days after Mini Mitter’s receipt of notice of the alleged defect or nonconformance. Buyer shall prepay transportation charges. Mini Mitter shall pay for the return of the goods to Buyer. No goods are to be returned to Mini Mitter without prior authorization and a valid Corrective Action Request (CAR) number. e) Limitation of Warranty The foregoing warranty shall not apply to defects resulting from (a) improper or inadequate maintenance by Buyer; (b) unauthorized modification of the goods; (c) operation of the goods outside of the environmental specifications for the goods; (d) neglect, misuse or abuse of the goods or (e) modification or integration with other goods not covered by a Mini Mitter warranty when such modifica- tion or integration increases the likelihood of damage to the goods. f) Technical assistance – The warranty set forth above shall not be enlarged, diminished or affected by and no obligation or liability shall arise from Mini Mitter’s rendering of technical advice, assistance or services in connection with Buyer’s order of the goods furnished hereunder. The Buyer is not relying on Mini Mitter's skill or judgment to select or furnish suitable goods. THE WARRANTY SET FORTH ABOVE IS EXCLUSIVE AND MINI MITTER GIVES NO OTHER WARRANTY WRITTEN OR VERBAL, EXPRESS OR IMPLIED. MINI MITTER SPECIFICALLY DISCLAIMS THE IMPLIED WARRANTIES OF MERCHANT- ABILITY AND FITNESS FOR A PARTICULAR PURPOSE. MINI MITTER’S STANDARD WARRANTY POLICY COVERING ANY MINI MITTER PRODUCTS SHALL BE NULL, VOID, AND OF NO EFFECT IF THE BUYER OR ANY THIRD PARTY USES THAT PRODUCT FOR ANY USE OTHER THAN THE INTENDED USE OF THAT PRODUCT. 2. LIMITATION OF REMEDIES AND LIABILITY. The remedies provided herein are Buyer’s sole and exclusive remedies. Mini Mitter shall have no responsibility other than, at Mini Mitter’s option, to repair or replace defective or nonconforming goods or to refund the purchase price of defective or nonconforming goods in the event of breach of any warranty. IN NO EVENT SHALL MM BE LIABLE FOR ANY DIRECT, INDIRECT SPECIAL, INCIDENTAL OR CONSEQUENTIAL DAMAGES (INCLUDING LOSS OF PROFITS) WHETHER BASED ON CONTRACT, TORT OR ANY OTHER LEGAL THEORY. In the event that any limitation of warranty or disclaimer of liabil- ity is found to be unlawful or inapplicable, or to have failed of its essential purpose, Mini Mitter’s liability shall be limited to the amount paid by the Buyer for the specific goods that caused such liability. 900-0016-01 3 Thank You!.....for purchasing Mini Mitter products. If you need assistance with VitalSense, remember Mini Mitter support continues after the purchase. If you have any problems or questions, please call our Technical Support staff of technicians, engineers, and scientists. We are available by telephone, fax, e-mail, or website. Contacting Mini Mitter Technical Support Mailing and Shipping Address Mini Mitter Company, Inc. 20300 Empire Avenue, Building B-3 Bend, OR 97701 USA Telephone(800) 685-2999 (541) 322-7272 Fax(541) 322-7277 [email protected] Websitewww.minimitter.com 4 Notice to Practitioners and Subjects Emissions This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules. These limites are designed to provide reasonable protection against harmful interference in a residential intallation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful inteference to radio communications. However, there is no guarantee that interference will not occur in a particular installation,. If this equipment does cause harmful inteference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures: • Reorient or relocated the receiving antenna. • Increase the separation between the equipment and receiver. • Connect the equipment into an outlet on a circuit different from that to which the receiver is connected. • Consult the dealer or an experienced radio TV technician for help. Interference This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: • This device may not cause harmful interference. • This device must accept any interference received, including interferences that may cause undesired operation. Modification of VitalSense Devices CAUTION! Any changes to the VitalSense monitor or sensors not expressly approved by Mini Mitter will void the practitioner or sub- ject the authority to operate the devices. i Technical Supportiii Introduct…

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Cover Letter(s)

MINI MITTER 20300 Empire Avenue, Building B-3·Bend, OR 97701 USA·Fax (541) 322-7277·Phone (541) 322-7272 email: [email protected] ·web page: http://www.minimitter.com PHYSIOLOGICAL AND BEHAVIORAL MONITORING FOR MICE TO MEN October 6, 2003 Attention FCC Application Reviewer: To comply with 47 CFR 2.925, paragraph (a), it is required that the transmitting device be labeled with an FCC Identifier which as quoted from subparagraph (1) must be “...preceded by the term FCC ID in capital letters on a single line, and shall be of a type size large enough to be legible without the aid of magnification.” Our device, the ingestible core temperature capsule, is only 22mm x 8mmφ. Therefore, it is impractical to label this device with the FCC ID. Additionally, the capsule transmitter is intended to be ingested, and therefore, the FCC ID would not be visible when in use. Following the directions stated in paragraph (e), Mini Mitter presents an alternative to a permanently affixed nameplate. As an alternative, Mini Mitter proposes to place the required FCC ID on the envelope in which the capsule transmitter is packaged. The capsule remains in this envelope until ready for use, at which time it is activated and swallowed. Please see the drawing for the proposed capsule label using the link below. Also below are photographs of the capsule packaging. With best regards, Donna Barton RF Design Engineer Mini Mitter Co., Inc. 20300 Empire Ave. Bldg B-3 Bend, Oregon 97701 http://www.minimitter.com Attachments. Link to Drawing of Proposed Capsule Label showing FCC ID# Capsule Label.pdf MINI MITTER 20300 Empire Avenue, Building B-3·Bend, OR 97701 USA·Fax (541) 322-7277·Phone (541) 322-7272 email: [email protected] ·web page: http://www.minimitter.com PHYSIOLOGICAL AND BEHAVIORAL MONITORING FOR MICE TO MEN Figure 2: Photograph of Proposed Capsule Envelope Label showing FCC ID#. The FCC label ID# is on the row third from the bottom. A photograph of the capsule sensor assembly and subassembly is placed next to the envelope for size comparison. MINI MITTER 20300 Empire Avenue, Building B-3·Bend, OR 97701 USA·Fax (541) 322-7277·Phone (541) 322-7272 email: [email protected] ·web page: http://www.minimitter.com PHYSIOLOGICAL AND BEHAVIORAL MONITORING FOR MICE TO MEN

External Photos

October 17, 2003 Mini Mitter Confidential Product Photos.doc 2 of 4 Figure 3: On the left is a photograph of the Dermal Patch Assembly with proposed FCC ID# label. On the right is the primary and secondary view of the Dermal Patch sensor subassembly.

ID Label/Location Info

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ID Label/Location Info

! " # $ % ! & & ' ! ! ! $ $ ! ( !$ ( ! ! )* ! ! ! + ! # ,-./0 10230$ 456 # 025$ 7 ' (7(# October 17, 2003 Mini Mitter Confidential Product Photos.doc 2 of 4 Figure 3: On the left is a photograph of the Dermal Patch Assembly with proposed FCC ID# label. On the right is the primary and secondary view of the Dermal Patch sensor subassembly.

Internal Photos

RF Exposure Info

RF Exposure evaluation There are two similar units granted under FCC ID: JIAXTP1: one version is intended for use on a person's body (Arm Patch), the other version to be ingested as a pill, for temporary operation within a person's body (Capsule). Identical circuitry is contained in each The measured Field Strength (at fundamental frequency of 40.68 MHz, at 3m distance) from the Capsule is less than 24 dB(μV/m) (please see page 10 of the test report). This corresponds to an EIRP of -70 dBm (or 10 -10 W). If the energy from the Capsule were to be totally absorbed in 1 gram of body tissue (theoretical threshold), the SAR would be 10 -7 W/kg. This is below the measurement threshold of common SAR test systems.

Test Report

EMC Report for Mini Mitter Co., Inc. on the models: Capsule & Arm Patch File: 30488991 Page 1 of 29 TEST REPORT Report Number: 30488991 Project Number: 3048899 September 29, 2003 Testing performed on the VitalSense Transmitters Models: Capsule and Arm Patch FCC ID: JIAXTP1 to FCC Part 15, Subpart C (15.229) for Mini Mitter Co., Inc. A2LA Certificate Number: 1755-01 Test Performed by: Test Authorized by: Intertek Testing Services 1365 Adams Court Menlo Park, CA 94025 Mini Mitter Co., Inc. 20300 Empire Ave., Bidg B-3 Bend, OR 97701 Prepared by: Date: September 29, 2003 Bruce Gordon Reviewed by: Date: September 30, 2003 David Chernomordik This report is for the exclusive use of Intertek's Client and is provided pursuant to the agreement between Intertek and its Client. Intertek's responsibility and liability are limited to the terms and conditions of the agreement. Intertek assumes no liability to any party, other than to the Client in accordance with the agreement, for any loss, expense or damage occasioned by the use of this report. Only the Client is authorized to copy or distribute this report and then only in its entirety. Any use of the Intertek name or one of its marks for the sale or advertisement of the tested material, product or service must first be approved in writing by Intertek. The observations and test results in this report are relevant only to the sample tested. This report by itself does not imply that the material, product, or service is or has ever been under an Intertek certification program. This report must not be used to claim product endorsement by A2LA, NIST nor any other agency of the U.S. Government. EMC Report for Mini Mitter Co., Inc. on the models: Capsule & Arm Patch File: 30488991 Page 2 of 29 TABLE OF CONTENTS 1.0 Summary of Tests ........................................................................................................................ 3 2.0 General Description ..................................................................................................................... 4 2.1 Product Description .......................................................................................................... 4 2.2 Related Submittal(s) Grants .............................................................................................. 5 2.3 Test Methodology ............................................................................................................. 5 2.4 Test Facility ...................................................................................................................... 5 3.0 System Test Configuration.......................................................................................................... 6 3.1 Support Equipment and description.................................................................................. 6 3.2 Block Diagram of Test Setup............................................................................................ 6 3.3 Justification ....................................................................................................................... 7 3.4 Software Exercise Program............................................................................................... 7 3.5 Mode of operation during test........................................................................................... 7 3.6 Modifications required for Compliance............................................................................ 7 3.7 Additions, deviations and exclusions from standards ....................................................... 7 4.0 Radiated emission measurements............................................................................................... 8 4.1 Requirements ....................................................................................................................8 4.2 Procedure .......................................................................................................................... 8 4.3 Field Strength Calculation ................................................................................................ 9 4.4 Test Result ...................................................................................................................... 10 4.5 Configuration photographs ............................................................................................. 19 5.0 Frequency Stability measurements .......................................................................................... 27 6.0 List of Test Equipment .............................................................................................................. 28 7.0 Document History ...................................................................................................................... 29 EMC Report for Mini Mitter Co., Inc. on the models: Capsule & Arm Patch File: 30488991 Page 3 of 29 1.0 Summary of Tests FCC ID: JIAXTP1 TEST REFERENCE RESULTS Field Strength on fundamental 15.229(a) Complies Spurious radiated emissions outside the band 15.229(c) Complies Frequency stability 15.229(d) Complies Antenna Requirement 15.203 Complies, antenna is integral part of the device Date of test: September 26, 2003 EMC Report for Mini Mitter Co., Inc. on the models: Capsule & Arm Patch File: 30488991 Page 4 of 29 2.0 General Description 2.1 Product Description The VitalSence system contains two sensors (transmitters) and monitor (receiver) operating in 40.66 – 40.70 MHz band. It is intended to monitor body core temperature and dermal surface temperature using telemetric sensors and receiver (monitor). Overview of the EUT Applicant name & address Mini Mitter Co., Inc. 20300 Empire Ave., Bidg B-3 Bend, OR 97701 Manufacturer Mini Mitter Co., Inc. FCC Identifier JIAXTP1 Type of Modulation FSK Rated RF Output Not rated Frequency Range 40.66 – 40.70 MHz Number of Channel(s) 0ne Antenna Integral part of the EUT A pre-production version of the EUT was received on…

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Test Report

Mini Mitter Co., Inc. Jonah Test Report Page ________________________________________________________________________ _____________________________________________________________________ MINI MITTER CO. CONFIDENTIAL September 26, 2003 1 Document Title: Frequency Stability for FCC Requirements Design tested: VitalSense Transmitter Date written: September 26, 2003 Test engineer: D. Barton Purpose of investigation: Verify that the transmitter meets FCC frequency stability requirements. 1.0 SUMMARY DESCRIPTION The capsule and patch transmitter circuits were tested to verify they meet FCC frequency stability requirements as outlined in 47CFR15.229. Under paragraph (d) of 15.229, the carrier frequency must not drift more than ±0.01% or ±100ppm over the temperature range of –20degC to 50degC. 2.0 DESIGNS TESTED Frequency stability of capsule transmitter Frequency stability of patch transmitter. 3.0 TEST SETUP Test Equipment: Spectrum Analyzer (HP8594E) Prototype receiver antenna. Alcohol/water bath capable of cooling (Julabo FP 45) Water bath capable of heating (Julabo model 27). Precision laboratory thermometer (Instrulab model 4202C-27-14) Two Capsule Transmitters with modulation disabled. Two Patch Transmitters with modulation disabled. Test Setup: The capsule transmitter and the patch transmitter had very similar test setups. The transmitters were tested in a special test mode which allowed them to continuously transmit. Two transmitters were tested simultaneously; one with a logic 1 applied to the modulation input, and the other with a logic 0 applied to the modulation input. The transmitters were tested over temperature, and then the logic on their data input lines was reversed. The transmitters were tested over temperature again. Since the transmitters have FSK modulation, this tested the frequency stability of the two sidebands. The average of the two sidebands results in the carrier frequency. Mini Mitter Co., Inc. Jonah Test Report Page ________________________________________________________________________ _____________________________________________________________________ MINI MITTER CO. CONFIDENTIAL September 26, 2003 2 The transmitters were cooled using an alcohol/water bath, and were heated using a water bath. The temperature of the water bath was controlled through the use of tanks specifically designed for precision temperature control (Julabo models FP 45 and 27). The temperature was measured by a precision laboratory thermometer (Instrulab model 4202C-27-14). The transmitters were lowered into crucibles filled with mineral oil. The mineral oil allowed better equilibration of temperature from the tank fluid to the transmitters. The transmitters were allowed to equilibrate at a particular temperature for 15 to 20min. before a reading was taken. The frequency was measured using a prototype receiver antenna and a spectrum analyzer (HP8594E). The results were recorded and graphed using Microsoft Excel. Figures 1 and 2 show photographs of the test setup. Both transmitters were tested over their full operating range. The patch transmitter was tested over the range –20degC to 60degC, and the capsule transmitter was tested over the range 20degC to 50degC. The capsule transmitter is intended as an ingestible sensor, and is not likely to see temperatures outside the range 32degC to 42degC. 3.1 TEST RESULTS Figure 3 shows a graph of the carrier frequency variation over temperature for two patch transmitters. Transmitter 1 (TX1) uses a FOX 325B type crystal as the resonator, and the transmitter 2 (TX2) uses a Golledge GSX-13 type crystal. Each was tuned slightly differently so as not to be exactly 40.68000MHz. Transmitter 1 exhibited a carrier frequency stability of +350Hz, -390Hz or +9ppm, -10ppm over the temperature range of –20degC to 60degC. Transmitter 2 exhibited a carrier frequency stability of +370Hz, -360Hz or +9ppm, -9ppm over the temperature range of –20degC to 60degC. This is well within the required limit of ±100ppm over the temperature range –20degC to 50degC. Figure 4 shows a graph of the sideband frequency variation over temperature of two capsule transmitters. The capsule transmitter is very similar to the patch transmitter. The patch transmitter has an emitter resistor feedback network which the capsule transmitter does not have. Otherwise, the capsule uses the same Pierce configuration with a crystal resonator. Both capsule transmitters used a GSX-13 crystal. Based on the data gathered from the patch transmitter, there is no reason to believe the sideband stability is not a good representation of the carrier stability. The sideband frequency variation data has been presented here for that reason. The capsule transmitter #1 data input was tied to logic 1 and transmitter #2 data input was tied to logic 0. The upper sideband exhibited a frequency stability of +320Hz, - 240Hz or +8ppm, -6ppm over the full operating temperature range 20degC to 50degC. The lower sideband exhibited a frequency stability of +190Hz, -160Hz or +5ppm, -4ppm over the temperature range 20degC to 50degC. This is also well within the frequency stability required limit of ±100ppm. The test results have been summarized in Table 1. Mini Mitter Co., Inc. Jonah Test Report Page ________________________________________________________________________ _____________________________________________________________________ MINI MITTER CO. CONFIDENTIAL September 26, 2003 3 Table 1. Summary of frequency stability test results for both patch and capsule type transmitters. Transmitter High Limit Actual positive drift Pass/Fail Patch TX #1 +100 ppm + 9 ppm Pass Patch TX #2 +100 ppm + 9 ppm Pass Capsule TX #1 + 100 ppm + 8 ppm Pass Transmitter Low Limit Actual negative drift Pass/Fail Patch TX #1 - 100 ppm - 10 ppm Pass Patch TX #2 - 100 ppm - 9 ppm Pass Capsule TX #1 - 100 ppm - 6 ppm Pass 4.0 CONCLUSIONS Both the patch-type transmitter and the capsule-type transmitter of the VitalSense system were tested fo…

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Test Setup Photos

FCC ID: JIAXTP1 FCC ID: JIAXTP1 FCC ID: JIAXTP1 FCC ID: JIAXTP1 FCC ID: JIAXTP1