DV8LX5160LX-5160

EXHIBIT D: User Manual FCC ID DV8LX5160 ECG & Respiration Transmitter LX-5160 Operation Manual Before using the LX-5160 you must first thoroughly read this manual. Remember to keep this operation manual in an easily accessible place near the unit for future reference. Only a physician or a person under the guidance of a physician can use this product. The information contained in this document is subject to change without notice due to improvement in the equipment. CAUTION Federal law restricts this device to sale by or on the order of a physician. 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. 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 Important Information 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 devices. If a problems exists, contact your local service representative. 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 replace the battery. CAUTION The manufacturers, installers and users of WMTS equipment are cautioned that the operation of this equipment could result in harmful interference to other nearby medical devices. ii Thank you for purchasing this instrument from Fukuda Denshi. Familiarize yourself with the correct operation of this instrument prior to operation. PRECAUTIONS FOR SAFE OPERATION AND HAZARD PREVENTION Installation and Storage • Install or store the instrument where it is free from moisture, splashed water, excessive dust, salt and direct sunlight. • Avoid excessive vibration and shock during operation or transport. • Do not store near chemicals, where gases are generated, or in a highly sulfuric atmosphere. Precautions before Operation • Do not operate this instrument in the presence of flammable gases. • Ensure the instrument is operating normally and safely. • When using the instrument in conjunction with another instrument, follow the appropriate instructions for both instruments. Caution during Operation Observe the instrument and patient for any abnormality. If abnormal operation occurs, remove the instrument from use and have it checked by the biomedical engineering department or contact your nearest Fukuda Denshi service representative. Cautions after Operation • Turn off the power switch when operation is complete. • Disconnect cables properly by holding the plug and pulling it out gently. • Clean the instrument prior to storing. Non-explosion-proof The instrument is not designed for operation in areas in which there is a risk of explosion. Be sure to perform a periodical inspection of the instrument and all accessories. iii CLEANING AND DISINFECTION Electrodes and electrode cables For disinfection, the electrodes and electrode cables should be rubbed with a swab or cloth moistened with a formaldehyde solution, such as Cidex 5%. Under no circumstances may the electrode cables be immersed in any cleaning fluid, nor may they be subjected to heat sterilization with water, steam, or air, or be subjected to ether sterilization. Transmitter The transmitter cabinet may be cleaned and disinfected in the following manner. Cleaning: Rub the unit with a cleaning cloth moistened with water to which an ordinary household cleaning agent can be added if necessary. But never use ether or benzene. Disinfection: Thoroughly spray the cabinet with a 5% Cidex or a similar product. Any and all modifications must be performed by an authorized Fukuda Denshi service representative. iv CAUTION Some pacemaker pulses are difficult or not possible to detect. This is dependent on the amplitude and width of the pacemaker pulse in addition to the type of pacemaker and lead type used (unipolar, bipolar, etc.). CAUTION QRS detection allows for detection of low amplitude ECG. But if excessive artifact is present on the ECG waveform, the noise may be detected as QRS in error. CAUTION Make sure each receiving telemetry channel corresponds to that of the transmitter worn by the patient. Instruct the patient wearing a telemetry transmitter to remain within the range of the antenna system. To avoid interference from other transmitters in the adjacent area or hospital, make sure the proper channel identification and group codes are used. Refer system settings to your Fukuda Denshi service representative. CONTENTS 1. GENERAL DESCRIPTION  1 2. CONTROLS AND INDICATORS  2 3. PREPARATION & OPERATION  4 1) Loading Battery  4 2) Turn the power switch to "ON"  5 3) Attaching Electrodes  6 4) Connecting lead wires …

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EXHIBIT A – Agent Authorization Letter FCC ID DV8LX5160 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.

EXHIBIT B – Request for Confidentiality FCC ID DV8LX5160 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: DV8LX5160; 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.

EXHIBIT M: Anti Drug Attestation FCC ID DV8LX5160 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.

EXHIBIT Q: Cover Letter from Agent FCC ID DV8LX5160 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 LX-5160 ECG and Respirator Transmitter, FCC ID: DV8LX5160. It is a portable biomedical telemetry transmitter operating in the 608- 614 MHz band. The patient cables act as an antenna for the device. The maximum operating output power is 1 milliwatt. Testing was performed with the transmitter set to maximum power. The LX-5160 is categorically excluded from routine evaluation for RF exposure due to its use, transmit frequency, and output power. The technical report and exhibits included with this application demonstrate compliance with FCC rules 47 CFR 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.

Exhibits for the FCC application of Fukuda Denshi's LX-5160 FCC ID DV8LX5160 ExhibitDescriptionFile nameConfidential Exhibit AAgent Authorization LetterAgent Authorization Letter.pdf Exhibit BRequest for confidentialityRequest for Confidentiality Exhibit CTechnical ReportTechnical Report.pdf Exhibit DUser Manual User Manual.pdf Exhibit EFCC ID LabelFCC ID Label.pdf Exhibit FRadiated Emissions Test DataRadiated Emissions.pdf Exhibit GSchematicsSchematics.pdf Yes Exhibit HFrequency Block DiagramFrequency Block Diagram.pdf Yes Exhibit IExternal PhotosExternal Photos.pdf Exhibit JInternal Photos Internal Photos.pdf Exhibit KPatient Lead PhotosPatient Leads.pdf Exhibit LTest Setup PhotosTest Setup 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 Exhbit Q Cover Letter from AgentCover Letter from Agent.pdf

EXHIBIT I: External Photos FCC ID DV8LX5160

EXHIBIT K: Patient Lead Photos FCC ID DV8LX5160

EXHIBIT E: FCC ID Label FCC ID DV8LX5160

EXHIBIT J: Internal Photos FCC ID DV8LX5160

EXHIBIT C Technical Report FCC ID DV8LX5160 Measurement/Technical Report Fukuda Denshi Model LX-5160 FCC ID: DV8LX5160 March 12, 2001 This report concerns (check one): Original Grant X Class II Change____ Equipment Type: Licensed Non-Broadcast Transmitter Worn on Body 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. FUKU0008 FCC ID: DV8LX5160 Northwest EMC, Inc. Report No. FUKU0008 Page 2 Table of Contents Section Description Page 1.0 General Information ................................................................................3 1.1 Product Description 3 1.1 Product Description - continued............................................................................... 4 1.3 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 Powerline Conducted Emissions .....................................................9 9.0 Radiated Emissions ..............................................................................10 9.1 Results ...................................................................................................................... 10 10.0 Field Strength Calculations ................................................................11 10.1 Measurement Bandwidths..................................................................................... 11 11.0 Measurement Equipment ....................................................................12 FCC ID: DV8LX5160 Northwest EMC, Inc. Report No. FUKU0008 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: ...................................................................................17725 NE 65 th Street Redmond, WA 98052 Model............................................................................ ..................................................................... LX-5160 FCC ID......................................................................................................................................... DV8LX5160 Serial Number(s) ................................................. .......................................................................... 00000001 Date of Test ...... ..................................................................................March 6, 2001 through March 9, 2001 Job Number .......................................................................... .......................................................... FUKU008 Prepared By: Vicki Albertson, Technical Report and Documentation Manager Technical Review By: Approved By: Dave Tolman, Software/QA Manager Greg Kiemel, Director of Engineering FCC ID: DV8LX5160 Northwest EMC, Inc. Report No. FUKU0008 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 LX-5160 Digital Telemetry Transmitter (FCC ID DV8LX5160), in accordance with Part 95.1115 of the Federal Communication Commission's Rules and Regulations. The Model LX-5160 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). This physiological data is in a digital format and 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 battery (1.5 volt alkaline type) powered UHF transmitter is worn by the patient. It operates on a 12.5kHz system channel spacing. It utilizes unused UHF television channels from 60…

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EXHIBIT F: Radiated Emissions Test Data FCC ID DV8LX5160 Rev 3.3 10/09/99 Comments: Frequency Meter ReadingDetector Antenna Factor Antenna PolarityPreamp GainCable Loss Table Azimuth Antenna Height Adjusted LevelSpec. LimitMargin Comment (MHz)(dBuV)(dB/m)(dB)(dB)(degrees)(meters)(dBuV/m)(dBuV/m)(dB) 611.00164.0QP19.3HLPA0.06.6298.01.589.9106.0-16.1Mid channel fundamental. 613.98863.7QP19.4HLPA0.06.6296.01.589.7106.0-16.3High channel fundamental. 608.01363.8QP19.3HLPA0.06.6297.01.589.7106.0-16.3 Low channel fundamental. 608.01361.1QP19.3VLPA0.06.6260.01.787.0106.0-19.0 Low channel fundamental. 611.00159.6QP19.3VLPA0.06.6257.01.585.5106.0-20.5Mid channel fundamental. 613.98859.4QP19.4VLPA0.06.6259.01.585.4106.0-20.6High channel fundamental. 03/08/01 James Tilley 2040 Battery Power. 4 Lead ECG Cable. LX51601 Fukuda Denshi FUKU0008 Temperature (°C):% Humidity: Customer Reference Number:Software:Power: Battery Power 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 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) 3069.93857.0PK31.9HHRN41.53.40.01.550.854.0-3.2 High Channel. 3069.93856.9PK31.9VHRN41.53.4300.01.150.754.0-3.3 High Channel. 1221.99862.9PK27.3VHRN41.41.4130.01.050.254.0-3.8Mid Channel. 1221.99862.9PK27.3HHRN41.41.460.01.050.254.0-3.8Mid Channel. 1841.96358.0PK29.6HHRN39.92.340.01.250.054.0-4.0 High Channel. 1216.02662.6PK27.3VHRN41.51.4160.01.149.854.0-4.3Low Channel. 3040.06955.9PK31.9VHRN41.53.4320.01.449.754.0-4.3Low Channel. 1227.97562.3PK27.3HHRN41.41.4335.01.449.654.0-4.5 High Channel. 3055.00055.5PK31.9HHRN41.53.40.01.249.354.0-4.7Mid Channel. 1216.02662.0PK27.3HHRN41.51.470.01.049.254.0-4.9Low Channel. 3040.06955.0PK31.9HHRN41.53.460.01.548.854.0-5.2Low Channel. 3069.93854.6AV31.9VHRN41.53.4300.01.148.454.0-5.6 High Channel. 3055.00054.5PK31.9VHRN41.53.4250.01.048.354.0-5.7Mid Channel. 1227.97561.0PK27.3VHRN41.41.4130.01.048.354.0-5.8 High Channel. 1221.99860.8AV27.3HHRN41.41.460.01.048.154.0-5.9Mid Channel. 1841.96356.1PK29.6VHRN39.92.3250.01.548.154.0-5.9 High Channel. 3069.93854.3AV31.9HHRN41.53.40.01.548.154.0-6.0 High Channel. 1227.97560.7AV27.3HHRN41.41.4335.01.448.054.0-6.1 High Channel. 1221.99860.6AV27.3VHRN41.41.4130.01.047.954.0-6.1Mid Channel. 1216.02660.5AV27.3VHRN41.51.4160.01.147.754.0-6.3Low Channel. 1216.02659.8AV27.3HHRN41.51.470.01.047.054.0-7.0Low Channel. 1841.96354.7AV29.6HHRN39.92.340.01.246.754.0-7.3 High Channel. 3055.00052.8AV31.9HHRN41.53.40.01.246.654.0-7.5Mid Channel. 1227.97558.9AV27.3VHRN41.41.4130.01.046.254.0-7.8 High Channel. 3040.06952.4AV31.9VHRN41.53.4320.01.446.254.0-7.8Low Channel. 3040.06952.2AV31.9HHRN41.53.460.01.546.054.0-8.0Low Channel. 1824.04054.1PK29.5VHRN40.02.3290.01.045.954.0-8.1Low Channel. 1832.99853.5PK29.6VHRN39.92.3250.01.045.554.0-8.5Mid Channel. 1832.99853.3PK29.6HHRN39.92.380.01.645.354.0-8.7Mid Channel. 1824.04053.2PK29.5HHRN40.02.370.01.245.054.0-9.0Low Channel. 3055.00050.6AV31.9VHRN41.53.4250.01.044.454.0-9.6Mid Channel. 1841.96351.6AV29.6VHRN39.92.3250.01.543.654.0-10.4 High Channel. 1824.04049.5AV29.5VHRN40.02.3290.01.041.354.0-12.7Low Channel. 1832.99847.9AV29.6VHRN39.92.3250.01.039.954.0-14.1Mid Channel. 1824.04047.9AV29.5HHRN40.02.370.01.239.754.0-14.3Low Channel. 1832.99847.3AV29.6HHRN39.92.380.01.639.354.0-14.7Mid Channel. 03/07/01 James Tilley 2233 Battery power. 4 Lead ECG cable. LX51601 Fukuda Denshi FUKU0008 Temperature (°C):% Humidity: Customer Reference Number:Software:Power: Battery Power 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 0.0 10.0 20.0 30.0 40.0 50.0 60.0 70.0 80.0 1216141616161816201622162416261628163016 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.

EXHIBIT P: Frequency Stability Attestation FCC ID DV8LX5160 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 LX-5160 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: LX-5160, 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 : Kenichi Kamisaka 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 0 611.24979 -207 -0.339 +10 611.24987 -125 -0.201 +20 611.250107 +107+0.175 +30 611.250067 +67+0.110 +40 611.249831 -169 -0.276 +50 611.249676 -324 -0.530

EXHIBIT L: Test Setup Photos FCC ID DV8LX5160