DV8HLX561HLX-561

Fukuda Denshi Co Ltd

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Application Details

Equipment Class: TNB - Licensed Non-Broadcast Station Transmitter
Date of Grant: Mar 28, 2001
Application Purpose: Original Equipment
Date of Application: Mar 28, 2001
Equipment Note: HLX-561
Frequency Range: 608.00000000 - 614.00000000
Company: Fukuda Denshi Co Ltd
Country: Japan

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

EXHIBIT D: User Manual FCC ID DV8HLX561 Telemetry Transmitter Module HLX-561 Operation Manual Read this manual prior to use of the HLX-561. Store this operation manual in an easily accessible place near the unit for future reference. CAUTION Federal law restricts this device to sale by or on the order of a physician. NOTE: Only a physician or a person under the guidance of a physician can use this device. Copyright © 2001 by Fukuda Denshi Co., Ltd. No part of this document may be copied or transmitted in any form without the prior written permission of Fukuda Denshi Co., Ltd. Printed in Japan i Telemetry Precautions For proper management of the telemetry installation, consult your Fukuda Denshi representative concerning the following: • Plan the installation of your telemetry system taking into account your entire medical facility needs and plant requirements. • Be sure the antenna system installed meets the facility and plant requirements. WARNING This Radio Frequency device is susceptible to interference from outside sources. Interference may prevent the monitoring of patients connected to this device. If problems exist contact your local service representative. NOTE : This device operates in the 600MHz UHF band. The exact frequency of operation depends on designation, and each individual county's wireless service regulation. To assure safe and reliable operation, observe the following precautions: • Be sure that no other devices are using the frequency assigned to this transmitter. • This device is susceptible to interference from electrosurgical knives and other computerized equipment. If problems occur contact your local Fukuda Denshi service representative. • Any obstruction such as reinforced concrete or large metallic surfaces between the receiver and the transmitter can affect reception. If problems occur contact your local Fukuda Denshi service representative. • When the low battery alarm is present at the central monitor, charge the battery in the patient monitor. ii CAUTION Users are advised to periodically contact the FCC or specified frequency coordinator and determine if other or your transmitter frequencies that may cause interference. CAUTION The manufacturers, installers and users of Wireless Medical Telemetry System equipment are cautioned that the operation of this equipment could result in harmful interference to other nearby medical devices. iii Thank you for purchasing the HLX-561 telemetry transmission module from Fukuda Denshi. Before use, read this operation manual thoroughly for correct handling and operation. If you are familiar with a similar type of product, it is recommended this operation manual be read and understood since the HLX-561 has unique operation and handling methods. Safety Information and Messages Be sure to observe the warning and cautionary messages related to important safety information. These instructions are described under the following message headings. Understand the meaning of the different types of messages while reading this operation manual. WARNING Erroneous operation by failure to observe instructions when this message is printed may result in death or serious injury to the patient, operator, or create a fire hazard. CAUTION Erroneous operation by failure to observe instructions when this message is printed may result in injury to the patient or operator, or may cause damage to the HLX-561 and/or related instruments. NOTE A NOTE is not a warning instruction but offers information for correct use of the HLX-561 to avoid erroneous operation. iv Safety Considerations in Using Medical Electrical Equipment Contents described here are general safety considerations to be taken for proper operation of medical electrical equipment and for the safety of both the patient and operator. Safety considerations specific to the use of the HLX-561 telemetry transmission module are described on the next page. CAUTION 1. Do not use the equipment unless familiar with its operation. 2. Observe the following when installing or storing the equipment: • Select a place where the equipment may not be contaminated with splashing water. • Consider the atmospheric pressure, temperature and humidity and provide adequate ventilation. Avoid direct sunlight. The equipment should not be installed or stored in a location where it may be adversely affected by air containing dust, saline or sulfur. • Avoid inclination, vibration and shock, even during transport to ensure stable operating conditions. • Do not install or store the equipment where chemicals are stored or gases are generated. 3. Precautions before Operation • The equipment is not designed to be explosion-proof. Do not use the equipment in the presence of flammable gasses or anesthetics. • Make sure the equipment is operating safely and normally at all times. Ensure that all cords and cables are correctly connected. • Improper use of multiple instruments simultaneously may result in erroneous information or lead to a hazardous accident. (Refer to the Section 9.) v CAUTION 4. Precautions during Operation • Do not to operate the equipment beyond the time period necessary that is required for diagnosis, monitoring or treatment. • Observe the equipment and patient constantly for any abnormality. • If the equipment or patient indicates any abnormality, stop the equipment from operating or take proper measures (e.g. disconnect transducers and electrodes) to ensure patient safety. • Instruct the patient not to contact the equipment. 5. Cares after Operation • Disconnect cords and cables by holding the connector plugs. Do not apply excessive force to cords and cables by pulling to disconnect. • Keep the equipment clean in preparation for the next use. 6. If the equipment gets out of order, ensure patient safety by immediately turning the equipment off and disconnecting electrodes and or transducers from the patient. Contact your nearest Fukuda representative and label the device as "OUT OF ORDER". 7. Do not d…

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Cover Letter(s)

EXHIBIT A – Agent Authorization Letter FCC ID DV8HLX561 17725 NE 65 th Street • Redmond, WA 98052 • Phone 1-800-365-6668 • Fax (425) 869-2018 February 10, 2001 Federal Communications Commission Authorization and Evaluation Division 7435 Oakland Mills Road Columbia, Maryland 21046 To whom it may concern, We, the undersigned, hereby authorize Northwest EMC, Inc. to act on our behalf, as our agent, in the following matters related to the FCC approval of our products: report submittal, related correspondence, the signing of all documents relating to these matters, and any other lawful activity necessary to obtain such certification. Any act carried out by Northwest EMC, Inc. within the scope of this authorization shall have the same affect as our own. This authorization shall expire 12 months from original date. Sincerely, Yoshi Muraki General Manager, Patient monitor R&D div., Fukuda Denshi Co., Ltd.

Cover Letter(s)

EXHIBIT M: Anti Drug Attestation FCC ID DV8HLX561 17725 NE 65 th Street • Redmond, WA 98052 • Phone 1-800-365-6668 • Fax (425) 869-2018 February 10, 2001 To whom it may concern, Re: Section 5301 (Anti-Drug Abuse) Certification This letter is to certify that neither the applicant nor any party to the application is subject to a denial of Federal benefits, this includes FCC benefits, pursuant to Section 5301 of Anti-Drug Abuse Act of 1988, 21 U.S.C. 862 because of a conviction for possession or distribution of controlled substance. Yoshi Muraki General Manager, Patient monitor R&D div., Fukuda Denshi Co., Ltd.

Cover Letter(s)

EXHIBIT Q: Cover Letter from Agent FCC ID DV8HLX561 Northwest EMC, INC. 22975 NW Evergreen Parkway, Suite 400 Hillsboro, OR 97124 March 26, 2001 Dear Application Examiner: On behalf of Fukuda Denshi Co., Ltd., Northwest EMC, Inc. is submitting this application for the certification of the HLX-561, FCC ID:DV8HLX561. It is a mobile biomedical telemetry transmitter operating in the 608- 614 MHz band. It uses a whip antenna part number FUKUDA 709, manufactured by Hidaka Denki, that is fixed to the device. The maximum operating output power is 1 millwatt. Testing was performed with the transmitter set to maximum output power. The EUT is categorically excluded from routine evaluation for RF exposure because of its use, transmit frequency and output power. This is a mobile device which will be used at a distance greater the 20 cm from all personnel. The technical report and exhibits included with this application demonstrate compliance with FCC rules 95.1115. An index of exhibits has been provided to facilitate the review process (see file “Index of Exhibits.pdf”). Please note that the field strength data of the fundamental emission is included in the spurious radiated emissions data (see file “Radiated Emissions.pdf”) Your efforts in reviewing this application are greatly appreciated. Best regards, Dave Tolman Northwest EMC, Inc.

Cover Letter(s)

Exhibits for the FCC Application of Fukuda Denshi's HLX-561 FCC ID DV8HLX561 ExhibitDescriptionFile nameConfidential Exhibit AAgent Authorization LetterAgent Authorization Letter.pdf Exhibit BRequest for confidentialityRequest for Confidentiality.pdf Exhibit CTechnical ReportTest Report.pdf Exhibit DUser Manual User Manual.pdf Exhibit EFCC ID LabelFCC ID Label.pdf Exhibit FRadiated Spurioius Emissions Test DataRadiated Emissions.pdf Exhibit GConducted Emissions Test DataConducted Emissions.pdf Exhibit HSchematicsSchematics.pdf Yes Exhibit IFrequency Block DiagramFrequency Block Diagram.pdf Yes Exhibit JExternal PhotosExternal Photos.pdf Exhibit KInternal Photos Internal Photos.pdf Exhibit LTest Setup PhotosSetup Photos.pdf Exhibit MAnti-Drug LetterAnti Drug Attestation.pdf Exhibit NTechnical DescriptionTech Description.pdf Yes Exhibit OTune-up ProcedureTune Up.pdf Yes Exhibit PFrequency Stability AttestationFrequency Stability.pdf Exhibit QCover Letter form AgentCover Letter from Agent.pdf

Cover Letter(s)

EXHIBIT P: Frequency Stability Attestation FCC ID DV8HLX561 17725 NE 65 th Street • Redmond, WA 98052 • Phone 1-800-365-6668 • Fax (425) 869-2018 February 26, 2001 To whom it may concern, Re: Temperature - Frequency stability Certification This letter is to certify that the Temperature – Frequency stability of the HLX-561 telemetry transmitter which is satisfied it’s specification over the operating temperature range. Yoshi Muraki General Manager, Patient monitor R&D div., Fukuda Denshi Co., Ltd. Test report of Frequency Stability EUT: HLX-561, Serial No. =00000001 Freq. Range : 608 to 614 MHz Freq. Stability : +/-2.5 ppm Operating temp. : +10 to +40 degrees C Date: Feb. 26. 2001 Manufacture: Fukuda Denshi Co., Ltd. Test engineer : Tamotsu Toya Test site: Fukuda Denshi, Hongo office, ME R&D Dept. Temp. Chamber: LHU-112, TABAI ESPEC CORP. Serial No.1571794 Registration No. 224-046-001 Freq. Counter: TR5823H, ADVANTEST Serial No.00570534 Registration No.202-027-001 Measurement result: Temp. degrees C Freq. MHz Diffrence, Hz Diffrence, ppm 0 610.999521 -479 -0.785 +10 610.999759 -241 -0.395 +20 611.000070 +70 +0.115 +30 611.000088 +88 +0.145 +40 611.000400 +400 +0.660 +50 611.000370 +370 +0.605

Cover Letter(s)

EXHIBIT B – Request for Confidentiality FCC ID DV8HLX561 17725 NE 65 th Street •• Redmond, WA 98052 •• Phone 1-800-365-6668 •• Fax (425) 869-2018 March 24, 2001 Federal Communications Commission Office of Engineering & Technology 7435 Oakland Mills Road Columbia, Maryland 21046 Re: FCC ID: DV8HLX561; Request for confidentiality Fukuda Densi Co., Ltd. has requested that the following exhibits of the referenced application be kept confidential pursuant to CFR 47, Section .457 and .459. The exhibits are "Tech Description.pdf", "Tune Up.pdf", "Schematics.pdf", and "Frequency Block Diagram.pdf". These contain schematic and operational details of the product for which certification is being sought. This information is classified as “Company Confidential” and disclosure of these exhibits would potentially be harmful to Fukuda Denshi Co., Ltd. business because this product incorporates innovative low- power RF transmitter design techniques, ECG processing technology, and other such details which would be useful to a competitor in the medical telemetry business. This information is not available to the public since all service and repairs are done on a sub-assembly basis and the design details are hidden. It is expected that this information would remain sensitive for at least two years from the date of submission. Sincerely, Yoshi Muraki General manager, Patient monitor R&D Div., Fukuda Denshi Co., Ltd.

External Photos

EXHIBIT J: External Photos FCC ID DV8HLX561

ID Label/Location Info

EXHIBIT E: Labeling FCC ID DV8HLX561

Internal Photos

EXHIBIT K: Internal Photos FCC ID DV8HLX561

Test Report

EXHIBIT C Technical Report FCC ID DV8HLX561 Measurement/Technical Report Fukuda Denshi Model HLX-561 FCC ID: DV8HLX561 March 12, 2000 This report concerns (check one): Original Grant X Class II Change____ Equipment Type:Licensed Non-Broadcast Transmitter Rule Part: 47 CFR 95.1115 Note: Part 95 Wireless Medical Telemetry Transmitter Deferred grant requested per 47 CFR 0.457 (d)(1)(ii)? Yes_____ no__X__ If yes, defer until: ______N/A______ Date Fukuda Denshi Co., Ltd. agrees to notify the Commission by: ______N/A______ Date of the intended date of announcement of the product so that the grant can be issued on that date. Report prepared by: Northwest EMC, Inc. 22975 NW Evergreen Pkwy. Ste 400 Hillsboro, OR 97124 (503) 844-4066 Fax: (503) 844-3826 Report No. FUKU0007 FCC ID: DV8HLX561 Northwest EMC, Inc. Report No. FUKU0007 Page 2 Table of Contents Section Description Page 1.0 General Information...................................................................................3 1.1 Product Description................................................................................................................3 1.2 Tested System Details............................................................................................................4 Figure 1: Configuration of Tested System..................................................5 1.4 Test Methodology....................................................................................................................6 1.5 Test Facility...............................................................................................................................6 2.0 System Test Configuration.......................................................................7 2.1 Justification...............................................................................................................................7 2.2 EUT Exercise Software..........................................................................................................7 2.3 Special Accessories...............................................................................................................7 2.4 Equipment Modifications.......................................................................................................7 3.0 Antenna Information...................................................................................8 4.0 RF Exposure Compliance Requirements..............................................8 5.0 Information to User.....................................................................................8 6.0 Type of Emission........................................................................................9 7.0 Necessary Bandwidth................................................................................9 8.0 AC Power Line Conducted Emissions.................................................10 8.1 Results.....................................................................................................................................10 9.0 Radiated Emissions.................................................................................11 9.1 Results.....................................................................................................................................11 10.0 Field Strength Calculations..................................................................12 10.1 Measurement Bandwidths................................................................................................12 11.0 Radiated and Conducted Measurement Equipment.......................13 FCC ID: DV8HLX561 Northwest EMC, Inc. Report No. FUKU0007 Page 3 1.0 General Information 1.1 Product Description Manufactured By......................................................................................Fukuda Denshi Tagajo Co.,Ltd. Address..............................................................................2-6-8 Sakae, Tagajo, Miyagii, 985-0833 Japan Test Requested By: ............................................................................................................Bob Steurer Address Fukuda Denshi USA, Inc. 17725 NE 65th Street, Redmond, WA, 98052 Model.......................................................................................................................................HLX-561 FCC ID...............................................................................................................................DV8HLX561 Serial Number(s) ................................................................................................................... 00000001 Date of Test .................................................................................................................March 6-9, 2001 Job Number ...........................................................................................................................FUKU007 Prepared By: Vicki Albertson, Technical Report and Documentation Manager Technical Review By: Approved By: FCC ID: DV8HLX561 Northwest EMC, Inc. Report No. FUKU0007 Page 4 1.1 Product Description - continued This application is being submitted in support of an equipment authorization request for the Fukuda Denshi Co., Ltd. Model HLX-561 Digital Telemetry Transmitter (FCC ID DV8HLX561), in accordance with Part 95.1115 of the Federal Communication Commission's Rules and Regulations. The Model HLX-561 is a multi-parameter biomedical telemetry transmitter that is used for the transmission of a patient's vital signs data from the patient monitor, including the electrocardiogram (ECG), and respiration (Resp), blood oxygen saturation, (SpO2), invasive blood pressure (IBP), non-invasive blood pressure (NIBP), and temperature (Temp). This physiological data is encoded in a digital format and is used to FSK-modulate a crystal controlled RF carrier. This device is intended for use within the confines of medical facilities. It is not intended for off-premise vehicular use. This device is powere…

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Test Report

EXHIBIT F: Radiated Emissions Test Data FCC ID DV8HLX561 Rev 3.3 10/09/99 Comments: Frequency Meter ReadingDetector Antenna Factor Antenna Polarity Preamp Gain Cable Loss Table Azimuth Antenna Height Adjusted LevelSpec. LimitMarginComment (MHz)(dBuV)(dB/m)(dB)(dB)(degrees)(meters)(dBuV/m)(dBuV/m)(dB) 400.00049.8QP15.6VLPA32.04.7361.01.338.146.0-7.9 328.00049.9QP15.0VLPA31.94.2339.01.737.246.0-8.8 120.00053.4QP13.3HBIC31.82.30.02.237.246.0-8.8 400.00148.7QP15.6HLPA32.04.788.02.137.046.0-9.0 328.00048.9QP15.0HLPA31.94.250.02.636.246.0-9.8 120.00051.8QP13.3VBIC31.82.3327.01.035.646.0-10.4 611.00069.6QP19.3VLPA0.06.685.01.595.5106.0-10.5Mid channel fundamental. 608.01369.6QP19.3VLPA0.06.694.01.595.5106.0-10.5Low channel fundamental. 132.00052.4QP12.3HBIC31.82.4343.02.435.346.0-10.7 613.98769.1QP19.4VLPA0.06.686.01.595.1106.0-10.9 High channel fundamental. 208.00051.5QP11.5HLPA31.83.2360.01.234.446.0-11.6 132.00050.7QP12.3VBIC31.82.439.01.033.646.0-12.4 208.00049.7QP11.5VLPA31.83.2231.02.232.646.0-13.4 608.01365.1QP19.3HLPA0.06.6180.01.291.0106.0-15.1Low channel fundamental. 611.00065.0QP19.3HLPA0.06.6181.01.290.9106.0-15.1Mid channel fundamental. 613.98764.7QP19.4HLPA0.06.6176.01.290.7106.0-15.3 High channel fundamental. 80.00051.5QP6.7VBIC32.02.0361.01.028.246.0-17.8 80.00051.2QP6.7HBIC32.02.0115.02.427.946.0-18.1 Part 95 WMTS Limit 3 meter Northwest EMC, Inc., Radiated and Conducted Emissions Data Sheets EUT:Serial Number:Job Number:Date: Manufacturer:Test Engineer:Job Site: SU04 Customer Reference Number:Software:Power: 120V/60Hz Temperature (°C):% Humidity: 03/08/01 James Tilley 2040 120V/60Hz. Transmitter mounted in DS-5100E (s/n:28100751). 3 Lead ECG cable. HLX5611 Fukuda Denshi FUKU0007 0.0 20.0 40.0 60.0 80.0 100.0 101001000 Frequency (MHz) dBuV/meter THIS DATA WAS ACQUIRED AT AN FCC LISTED FACILITY THE FACILITY MEETS ANSI C63.4 SITE ATTENUATION REQUIREMENTS. THIS FINAL DATA REPRESENTS MAXIMIZED (CABLES, ANTENNA & TURNTABLE) MEASUREMENTS. Rev 3.3 10/09/99 Comments: Frequency Meter ReadingDetector Antenna Factor Antenna PolarityPreamp GainCable Loss Table Azimuth Antenna Height Adjusted LevelSpec. LimitMarginComment (MHz)(dBuV)(dB/m)(dB)(dB)(degrees)(meters)(dBuV/m)(dBuV/m)(dB) 1216.02362.3PK27.3VHRN41.51.4220.01.149.554.0-4.5Low Channel. 1221.99961.5PK27.3VHRN41.41.4150.01.148.854.0-5.3Mid Channel. 1227.97661.0PK27.3VHRN41.41.4155.01.148.354.0-5.8High Channel. 1227.97660.3PK27.3HHRN41.41.450.01.447.654.0-6.4High Channel. 1216.02360.1PK27.3HHRN41.51.4170.01.547.354.0-6.7Low Channel. 1221.99959.9AV27.3VHRN41.41.4150.01.147.254.0-6.9Mid Channel. 1221.99959.5PK27.3HHRN41.41.420.01.446.854.0-7.2Mid Channel. 1216.02359.3AV27.3VHRN41.51.4220.01.146.554.0-7.5Low Channel. 1227.97658.6AV27.3VHRN41.41.4155.01.145.954.0-8.1High Channel. 1227.97657.1AV27.3HHRN41.41.450.01.444.454.0-9.6High Channel. 1216.02356.7AV27.3HHRN41.51.4170.01.543.954.0-10.1Low Channel. 1221.99956.1AV27.3HHRN41.41.420.01.443.454.0-10.6Mid Channel. Part 95 WMTS Limit 3 meter Northwest EMC, Inc., Radiated and Conducted Emissions Data Sheets EUT:Serial Number:Job Number:Date: Manufacturer:Test Engineer:Job Site: SU01 Customer Reference Number:Software:Power: 120V/60Hz Temperature (°C):% Humidity: 03/07/01 James Tilley 2233 120V/60Hz. Transmitter mounted in DS-5100E (s/n:28100751). 3 Lead ECG cable. HLX5611 Fukuda Denshi FUKU0007 0.0 10.0 20.0 30.0 40.0 50.0 60.0 70.0 80.0 121612261236124612561266127612861296 Frequency (MHz) dBuV/meter THIS DATA WAS ACQUIRED AT AN FCC LISTED FACILITY THE FACILITY MEETS ANSI C63.4 SITE ATTENUATION REQUIREMENTS. THIS FINAL DATA REPRESENTS MAXIMIZED (CABLES, ANTENNA & TURNTABLE) MEASUREMENTS.

Test Report

EXHIBIT G: Conducted Emissions Data FCC ID DV8HLX561 Rev 3.3 10/09/99 Comments: FrequencyDetector Adjusted LevelMargin (MHz)(dBuV)(dB) 20.026Peak44.1-3.9 0.482Peak40.2-7.8 13.065Peak38.9-9.1 15.025Peak38.7-9.3 0.621Peak38.0-10.0 0.622Peak38.0-10.0 18.065Peak37.9-10.1 25.050Peak37.7-10.3 19.698Peak37.6-10.4 19.171Peak37.4-10.6 19.322Peak37.4-10.6 18.970Peak37.3-10.7 22.056Peak37.0-11.0 19.497Peak36.9-11.1 11.106Peak36.8-11.2 19.874Peak36.6-11.4 10.377Peak36.6-11.4 10.905Peak36.6-11.4 18.819Peak36.5-11.5 11.357Peak36.3-11.7 03/06/01 James Tilley 2233 120V/60Hz. Transmitter mounted in DS-5100E (s/n:28100751). 3 Lead ECG cable. Hi channel. HLX5611 Fukuda Denshi FUKU0007 Test Equipment Test System Temperature (°C):% Humidity: Customer Reference Number:Software:Power: FCC Part 15 Class B Conducted Emissions Limits - High Line Northwest EMC, Inc., Radiated and Conducted Emissions Data Sheets EUT:Serial Number:Job Number:Date: Manufacturer:Test Engineer:Job Site: SU01 15.620.948.0 15.520.848.0 15.820.848.0 15.820.848.0 16.020.848.0 15.720.948.0 16.120.948.0 16.020.948.0 16.520.948.0 16.420.948.0 16.720.948.0 16.520.948.0 17.020.948.0 16.721.048.0 18.020.048.0 18.020.048.0 18.020.948.0 17.820.948.0 23.220.948.0 20.220.048.0 Meter ReadingCorrection FactorSpecification Limit (dBuV)(dB)(dBuV) 10.0 15.0 20.0 25.0 30.0 35.0 40.0 45.0 50.0 0.1001.00010.000100.000 Frequency (MHz) dBuV Rev 3.3 10/09/99 Comments: FrequencyDetector Adjusted LevelMargin (MHz)(dBuV)(dB) 20.052Peak44.3-3.7 0.482Peak41.5-6.5 13.065Peak39.2-8.8 0.623Peak39.1-8.9 15.050Peak38.4-9.6 0.761Peak38.0-10.0 18.065Peak38.0-10.0 19.146Peak37.8-10.2 19.523Peak37.8-10.2 12.060Peak37.6-10.4 0.758Peak37.5-10.5 19.874Peak37.4-10.6 19.698Peak37.0-11.0 18.970Peak37.0-11.0 19.322Peak36.9-11.1 25.050Peak36.9-11.1 11.055Peak36.8-11.2 11.533Peak36.7-11.3 10.729Peak36.7-11.3 18.794Peak36.6-11.4 03/06/01 James Tilley 2233 120V/60Hz. Transmitter mounted in DS-5100E (s/n:28100751). 3 Lead ECG cable. Hi channel. HLX5611 Fukuda Denshi FUKU0007 Test Equipment Test System Temperature (°C):% Humidity: Customer Reference Number:Software:Power: FCC Part 15 Class B Conducted Emissions Limits - Low Line Northwest EMC, Inc., Radiated and Conducted Emissions Data Sheets EUT:Serial Number:Job Number:Date: Manufacturer:Test Engineer:Job Site: SU01 15.920.848.0 15.720.948.0 16.020.848.0 15.920.848.0 16.020.948.0 15.921.048.0 16.120.948.0 16.120.948.0 17.520.048.0 16.520.948.0 16.920.948.0 16.820.848.0 17.120.948.0 16.920.948.0 17.520.948.0 18.020.048.0 18.320.948.0 19.120.048.0 23.420.948.0 21.520.048.0 Meter ReadingCorrection FactorSpecification Limit (dBuV)(dB)(dBuV) 10.0 15.0 20.0 25.0 30.0 35.0 40.0 45.0 50.0 0.1001.00010.000100.000 Frequency (MHz) dBuV Rev 3.3 10/09/99 Comments: FrequencyDetector Adjusted LevelMargin (MHz)(dBuV)(dB) 20.052Peak43.3-4.7 0.483Peak41.7-6.3 0.484Peak41.7-6.3 18.065Peak39.5-8.5 11.055Peak39.3-8.7 0.622Peak38.8-9.2 13.065Peak38.7-9.3 0.616Peak38.6-9.4 15.050Peak38.4-9.6 12.060Peak38.0-10.0 19.497Peak38.0-10.0 0.759Peak37.9-10.1 0.758Peak37.9-10.1 18.945Peak37.5-10.5 19.322Peak37.4-10.6 25.050Peak37.2-10.8 19.121Peak37.1-10.9 19.673Peak37.1-10.9 19.849Peak36.7-11.3 18.769Peak36.7-11.3 03/06/01 James Tilley 2233 120V/60Hz. Transmitter mounted in DS-5100E (s/n:28100751). 3 Lead ECG cable. Mid channel. HLX5611 Fukuda Denshi FUKU0007 Test Equipment Test System Temperature (°C):% Humidity: Customer Reference Number:Software:Power: FCC Part 15 Class B Conducted Emissions Limits - Low Line Northwest EMC, Inc., Radiated and Conducted Emissions Data Sheets EUT:Serial Number:Job Number:Date: Manufacturer:Test Engineer:Job Site: SU01 15.820.948.0 15.820.948.0 16.220.948.0 16.220.948.0 16.520.948.0 16.221.048.0 17.920.048.0 16.620.948.0 17.120.948.0 17.920.048.0 17.520.948.0 17.220.848.0 17.820.948.0 18.620.048.0 18.520.848.0 18.820.048.0 21.720.048.0 18.620.948.0 22.420.948.0 21.720.048.0 Meter ReadingCorrection FactorSpecification Limit (dBuV)(dB)(dBuV) 10.0 15.0 20.0 25.0 30.0 35.0 40.0 45.0 50.0 0.1001.00010.000100.000 Frequency (MHz) dBuV Rev 3.3 10/09/99 Comments: FrequencyDetector Adjusted LevelMargin (MHz)(dBuV)(dB) 20.052Peak43.0-5.0 0.479Peak40.4-7.6 11.055Peak39.5-8.5 0.484Peak39.4-8.6 13.065Peak39.4-8.6 18.040Peak38.9-9.1 15.050Peak38.9-9.1 0.618Peak37.6-10.4 19.849Peak37.5-10.5 19.296Peak37.4-10.6 12.060Peak37.3-10.7 0.623Peak37.2-10.8 19.121Peak37.2-10.8 10.880Peak37.1-10.9 11.156Peak37.0-11.0 18.945Peak37.0-11.0 18.744Peak37.0-11.0 10.528Peak36.9-11.1 19.648Peak36.9-11.1 22.056Peak36.8-11.2 03/06/01 James Tilley 2233 120V/60Hz. Transmitter mounted in DS-5100E (s/n:28100751). 3 Lead ECG cable. Mid channel. HLX5611 Fukuda Denshi FUKU0007 Test Equipment Test System Temperature (°C):% Humidity: Customer Reference Number:Software:Power: FCC Part 15 Class B Conducted Emissions Limits - High Line Northwest EMC, Inc., Radiated and Conducted Emissions Data Sheets EUT:Serial Number:Job Number:Date: Manufacturer:Test Engineer:Job Site: SU01 16.020.948.0 15.920.948.0 16.120.948.0 16.120.848.0 16.220.848.0 16.120.948.0 16.320.948.0 16.320.848.0 16.520.848.0 17.220.048.0 16.620.948.0 16.520.948.0 18.020.948.0 17.620.048.0 18.520.948.0 18.020.948.0 18.720.848.0 19.420.048.0 22.120.948.0 20.420.048.0 Meter ReadingCorrection FactorSpecification Limit (dBuV)(dB)(dBuV) 10.0 15.0 20.0 25.0 30.0 35.0 40.0 45.0 50.0 0.1001.00010.000100.000 Frequency (MHz) dBuV Rev 3.3 10/09/99 Comments: FrequencyDetector Adjusted LevelMargin (MHz)(dBuV)(dB) 20.052Peak41.9-6.1 11.055Peak40.4-7.6 0.480Peak40.3-7.7 13.065Peak39.2-8.8 15.050Peak38.6-9.4 18.920Peak38.0-10.0 18.065Peak37.7-10.3 22.056Peak37.7-10.3 0.621Peak37.5-10.5 19.271Peak37.4-10.6 19.648Peak37.3-10.7 11.307Peak37.3-10.7 10.528Peak37.0-11.0 10.880Peak36.8-11.2 12.060Peak36.8-11.2 19.824Peak36.8-11.2 19.070Peak36.5-11.5 25.050Peak36.4-11.6 10.050Peak36.4-11.6 19.447Peak36.4-11.6 03/06/01 James Tilley 2233 120V/60Hz. Transmitter mounted in DS-5100E (s/n:28100751). 3 Lead ECG cable. Low channel. HLX5611 Fukud…

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Test Setup Photos

EXHIBIT L: Test Setup Photos FCC ID DV8HLX561

Test Setup Photos

EXHIBIT L: Test Setup Photos FCC ID DV8HLX561

Contact Information

Applicant

Takashi Nomura(General Manager)

[email protected]81-3-5684-1540Fax: 81-3-5684-1875

Technical Contact

Northwest EMC, Inc.Dave Tolman

[email protected]503-844-4066

22975 NW Evergreen Parkway · Hillsboro, Oregon · United States

Non-Technical Contact

Northwest EMC, Inc.Vicki Albertson

[email protected]503-844-4066

Test Firm

Northwest EMC, Inc.Greg Kiemel

[email protected]503-844-4066Fax: 503-844-3826

Technical Specifications

#	Rule Parts	Frequency Range	Power Output	Emission	Tolerance
1	95A	608 MHz - 614 MHz	1.00 mW	10K5F1D	2.5000000000 ppm

Confidentiality

Long Term

Grant Notes

Power is ERP. This mobile transmitter is approved under Part 95 Wireless Medical Telemetry Service (WMTS). It is only approved for use in a manner that satisfies the mobile operating requirements of Section 2.1091. The only antennas approved for use with this transmitter are those documented in the filing and must be installed in the manner specified therein. This transmitter must not be co-located or operated in conjunction with any other antenna or transmitter.