DV8LX7120ECG & Respiration Transmitter

ECG & Respiration Transmitter LX-7120 Operation Manual ● Before using this device, read this operation manual thoroughly. ● Keep this manual near the device for future reference. 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. CAUTION: • This device for sale by or on the order of a physician. • The company and product names used in this manual are trademarks or registered trademarks. • If this manual has pages missing or out of order, contact Fukuda Denshi for replacement. • Only physician or persons instructed by physicians are allowed to use the equipment. • The information contained in this document is subject to change without notice due to improvement in the equipment. Copyright © 2010 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 Thank you for purchasing this product from Fukuda Denshi. Before use, read this operation manual thoroughly for correct handling and operation. Safety Precautions  Read the “Safety Precautions” thoroughly before use to ensure correct and safe use of the product.  Make sure to follow the precautions indicated below, as these are important messages related to safety. DANGER Failure to follow this message may cause immediate threat of death or serious injury. WARNING Failure to follow this message may result in death or serious injury. CAUTION Failure to follow this message may cause injury or failure to the equipment. NOTE A note is not related to product safety, but provides information about the correct use and operating procedures to prevent incorrect operation and malfunction of the equipment. Precaution from Fukuda Denshi Fukuda Denshi is liable for the safety, reliability, and performance of its device only if;  Maintenance, modifications, and repairs are carried out by authorized personnel.  Components are used in accordance with Fukuda Denshi operating instructions. If the equipment is used incorrectly and become unusable, Fukuda Denshi is not liable for the malfunction. Use the equipment only for the purpose specified in this manual. i Equipment Symbols Refer to the following symbols indicated on the LX-7120 for their meanings. Symbols indicated on the main unit Symb ol Description Caution; read the operation manual. Indicates the need to refer to the operation manual before operation. Type CF Applied Part with Defibrillation-Proof Indicates that the degree of protection against electric shock is Type CF Applied Part with defibrillation-proof. Indicates the battery type and direction. Symbols indicated on the LCD screen Symbol Description Heart Rate Synchronization Mark: This mark flashes synchronizing with the heartbeat. Battery Mark: Indicates the remaining battery level. ii Precautions for Safe Operation of Medical Electrical Equipment Cautions described here are regarding the general instructions for safety use to the patient and the operator. As for cautions about the LX-7120, please refer to the following pages. CAUTION 1. Users should have a thorough knowledge of the operation before using this equipment. 2. Pay attention to the following when installing or storing the equipment.  Do not install or store in an area where the equipment will be subject to splashing water.  Do not install or store in an area where the environmental conditions, such as atmospheric pressure, temperature, humidity, ventilation, sunlight, dust, sodium, sulfur, will adversely affect the system.  Place the equipment on a stable surface where there is no inclination, vibration, or shock (including during transportation).  Do not install or store in an area where chemicals are stored or gases are generated. 3. Before operating the equipment, verify the following items.  Check the cable connection and polarity to ensure proper operation of the equipment.  Ensure that all cables are firmly and safely connected. Especially, recheck the attachment and connection condition of electrode.  Pay special attention when the equipment is used in conjunction with other equipment as it may cause erroneous judgment and danger.  Check the remaining battery level.  When replacing the battery, make sure that the battery polarity is correct. Do not charge the battery. 4. During operation of the equipment, verify the following items.  Do not operate the equipment beyond the time period required for diagnosis and medical care.  Do not pick up and/or swing the equipment pulling/grabbing the cable part. It may damage the equipment and lead to measurement error.  Always observe the equipment and patient to ensure safe operation of the equipment.  If any abnormality is found on the equipment or patient, take appropriate measures such as ceasing operation of the equipment and/or electrode, in the safest way for the patient.  Do not allow the patient to come in contact with other equipments. iii CAUTION 5. After using the equipment, verify the following items.  Make sure to turn off the power of the equipment.  When unplugging the cables, do not apply excessive force on the cable and pull from its connector.  Clean the accessories and cables, and keep them together in one place.  Keep the equipment clean to ensure proper operation for the next use.  Make sure to remove the battery if the equipment is not used for a long time. The leakage from the battery may damage the device or an explosion from the battery may occur. 6. If the equipment is damaged and in need of repair, ensure patient safety by immediately turning the equipm…

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Antenna Photo Fukuda Denshi Co Ltd FCC ID: DV8LX7120

External Photo Fukuda Denshi Co Ltd FCC ID: DV8LX7120 Front Rear External Photo Fukuda Denshi Co Ltd FCC ID: DV8LX7120 Top Bottom External Photo Fukuda Denshi Co Ltd FCC ID: DV8LX7120 Left Right

Label Location

Internal Photo Fukuda Denshi Co Ltd FCC Id: DV8LX7120 Internal Photo Fukuda Denshi Co Ltd FCC Id: DV8LX7120

Test report No. : 30JE0026-YK-01 Page : 2 of 28 Issued date : June 29, 2010 FCC ID : DV8LX7120 UL Japan, Inc. SHONAN EMC LAB. 1-22-3 Megumigaoka, Hiratsuka-shi, Kanagawa-ken 259-1220 JAPAN Telephone: +81 463 50 6400 Facsimile: +81 463 50 6401 CONTENTS Page SECTION 1: Customer information..................................................................................... 3 SECTION 2: Equipment under test (E.U.T.) ....................................................................... 3 SECTION 3: Test specification, procedures and results ...................................................... 4 SECTION 4: Operation of E.U.T. during testing................................................................. 6 SECTION 5: Field Strength (Fundamental Emission & Out of band emissions) ............... 7 SECTION 6: Frequency Stability ......................................................................................... 9 SECTION 7: Bandwidth & Occupied bandwidth (99%) .................................................... 9 SECTION 8: Spurious emissions at antenna terminals ....................................................... 9 Contents of APPENDIXES................................................................................................... 10 APPENDIX 1: Photographs of test setup ........................................................................... 11 APPENDIX 2: EMI test data .............................................................................................. 14 APPENDIX 3: Test instruments ......................................................................................... 28 Test report No. : 30JE0026-YK-01 Page : 3 of 28 Issued date : June 29, 2010 FCC ID : DV8LX7120 UL Japan, Inc. SHONAN EMC LAB. 1-22-3 Megumigaoka, Hiratsuka-shi, Kanagawa-ken 259-1220 JAPAN Telephone: +81 463 50 6400 Facsimile: +81 463 50 6401 SECTION 1: Customer information Company Name : FUKUDA DENSHI CO.,LTD. Address : 35-8, Hongo 2-chome, Bunkyo-ku,Tokyo 113-8420, Japan Telephone Number : +81-3-5684-1480 Facsimile Number : +81-3-5684-1321 Contact Person : Kenichi Kamisaka SECTION 2: Equipment under test (E.U.T.) 2.1 Identification of E.U.T. Type of Equipment : ECG & Respiration Transmitter Model No. : LX-7120 Serial No. : 001 Rating : DC1.5V Country of Mass-production : Japan Receipt Date of Sample : June 11, 2010 Condition of EUT : Engineering prototype (Not for Sale: This sample is equivalent to mass-produced items.) Modification of EUT : No Modification by the test lab 2.2 Product description Model No: LX-7120, referred to as the EUT in this report, is the ECG & Respiration Transmitter. General Specification Clock frequency(ies) in the system : (No Radio part, CPU) 8MHz, (Radio part, TCXO) 9.600MHz Radio Specification ITU code ( Emission designator) : 7K4F1D Radio Type : Transmitter Frequency of Operation : 608.0125 through 613.9875MHz Modulation : Digital Frequency Shift Keying RF Output Power (E.I.R.P.) : 1.6mW or less *1) RF Output Power Limit : 200mV/m at 3m ( = 106dBuV/m at 3m ) Power Supply (Radio part) : DC 1.5V, DC 3.0V Antenna type : cable Antenna Antenna Gain : -8.5dBi Operating Temperature : 10 to 40 deg. C. Frequency stability : +/- 2.5ppm Data rate : 7000 bps (NRZ) *1) RF Output Power is fixed as shown in “08 (Confidential) Theory of Operation.pdf” and this product is shipped. [ Radio part power supply ] The equipment provides the Radio part with stable power supply (DC1.5V, DC3.0V), therefore, the equipment complies power supply regulation. Revised date : November 26, 2010 Test report No. : 30JE0026-YK-01 Page : 4 of 28 Issued date : June 29, 2010 FCC ID : DV8LX7120 UL Japan, Inc. SHONAN EMC LAB. 1-22-3 Megumigaoka, Hiratsuka-shi, Kanagawa-ken 259-1220 JAPAN Telephone: +81 463 50 6400 Facsimile: +81 463 50 6401 SECTION 3: Test specification, procedures and results 3.1 Test specification Test specification : FCC Part95 Subpart H: 2010, final revised on April 14, 2010 Title : FCC 47CFR Part95 Personal Radio Services Subpart H Wireless Medical Telemetry Service (WMTS) Subpart 95.1115 General technical requirements. Test specification : FCC Part2 Subpart J: 2009, final revised on May 14, 2009 Title : FCC 47CFR Part2 Frequency Allocations and Radio Treaty Matters; General Rules and Regulations Subpart J Equipment Authorization Procedures 3.2 Procedures & results Item Test Procedure Specification Remarks DeviationWorst Margin Results Field Strength of Fundamental Emission FCC Section 2.1046, ANSI/TIA-603-C:2004 FCC Section 95.1115(a)(1) Radiated N/A 12.3dB (Horizontal, Tx 611.0000MHz, QP) Complied *1) Field Strength of Out of band emissions FCC Section 2.1053, ANSI/TIA-603-C:2004 FCC Section 95.1115(b)(1)(2) Radiated N/A 1.2dB (3040.063MHz, Horizontal, Tx 608.0125MHz, AV) Complied Frequency Stability FCC Section 2.1055, ANSI/TIA-603-C:2004 FCC Section 95.1115(e) ConductedN/A - Complied Bandwidth FCC Section 2.1049, ANSI/TIA-603-C:2004 Applicant specification ConductedN/A - Complied Spurious emissions at antenna terminals FCC Section 2.1051, ANSI/TIA-603-C:2004 (Reference) ConductedN/A - Complied Note: UL Japan’s EMI Work Procedures No.QPM05 and QPM15. *1), This device were tested by radiated not conducted. 3.3 Addition to standard No addition, deviation or exclusion has been made from standards. Revised date : November 17, 2010 Test report No. : 30JE0026-YK-01 Page : 5 of 28 Issued date : June 29, 2010 FCC ID : DV8LX7120 UL Japan, Inc. SHONAN EMC LAB. 1-22-3 Megumigaoka, Hiratsuka-shi, Kanagawa-ken 259-1220 JAPAN Telephone: +81 463 50 6400 Facsimile: +81 463 50 6401 3.4 Uncertainty The following uncertainties have been calculated to provide a confidence level of 95% using a coverage factor k=2. Item Frequency range No.1 SAC *1 /SR *2 (±) No.2 SAC/SR (±) No.3 SAC/SR (±) 30MHz-300MHz 4.6 dB 4.5 dB 4.9 dB 300MHz-1GHz 4.5 dB 4.6 dB 5.1 dB Radiated emission (Measurement distance: 3m) 1GHz-7GHz 3.9 dB 3.9 dB 4.0 dB *1: SAC=Semi-Anechoic Chamber *2: SR= Shielded Room is applied besid…

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FCC ID : DV8LX7120 Test Report No. :30JE0026-YK-01 Page :14/ 28 Issued date : June 29, 2010 APPENDIX 2: EMI test data Test placeUL Japan, Inc. Shonan EMC Lab. No.5 Shielded Room Date2010/6/18 Temperature / Humidit y23deg.C., 53% Enginee rAkio Hayashi ModeTransmitting TestMeasuredFreqResultLimitMargin Timin gfreqerror deg.CVolts[MHz][MHz][ppm][+/- ppm][ppm] Power o n608.0126220.0001220.202.502.30 on 2min.608.0126090.0001090.182.502.32 on 5min.608.0126180.0001180.192.502.31 on 10min.608.0126320.0001320.222.502.28 Power o n608.0128650.0003650.602.501.90 on 2min.608.0128630.0003630.602.501.90 on 5min.608.0128600.0003600.592.501.91 on 10min.608.0128420.0003420.562.501.94 Power o n----- on 2min.----- on 5min.----- on 10min.----- Power o n----- on 2min.----- on 5min.----- on 10min.----- Power o n608.012297-0.000203-0.332.502.17 on 2min.608.012316-0.000184-0.302.502.20 on 5min.608.012313-0.000187-0.312.502.19 on 10min.608.012283-0.000217-0.362.502.14 Power o n608.0125120.0000120.022.502.48 on 2min.608.0125250.0000250.042.502.46 on 5min.608.0125200.0000200.032.502.47 on 10min.608.0125340.0000340.062.502.44 Power o n608.0128650.0003650.602.501.90 on 2min.608.0128630.0003630.602.501.90 on 5min.608.0128600.0003600.592.501.91 on 10min.608.0128420.0003420.562.501.94 Power o n608.0129240.0004240.702.501.80 on 2min.608.0129190.0004190.692.501.81 on 5min.608.0129270.0004270.702.501.80 on 10min.608.0129310.0004310.712.501.79 Power o n----- on 2min.----- on 5min.----- on 10min.----- Power o n----- on 2min.----- on 5min.----- on 10min.----- Power o n----- on 2min.----- on 5min.----- on 10min.----- Limit :608.0125 MHz +/-0.00025 % (+/- 2.5ppm) =+/- 0.001520 MH z *The test on 50deg.C., 0deg.C., -10deg.C., and -20deg.C. were not apply, since the specification of operating temperature of EUT was 10deg.C to 40deg.C. 50deg.C. 1.5V 40deg.C. 30deg.C. 20deg.C. 10deg.C. 0deg.C. -10deg.C. -20deg.C Frequency Stability Test Condition 20deg.C 0.9V (Vmin) 1.5V (Vnom) UL Japan, Inc. Shonan EMC Lab. 1-22-3 Megumigaoka, Hiratsuka-shi, Kanagawa 259-1220 JAPAN Telephone : +81 463 50 6400 Facsimile : +81 463 50 6401 FCC ID : DV8LX7120 Test Report No. :30JE0026-YK-01 Page :15/ 28 Issued date : June 29, 2010 Test placeUL Japan, Inc. Shonan EMC Lab. No.5 Shielded Room Date2010/6/18 Temperature / Humidit y23deg.C., 53% Enginee rAkio Hayashi ModeTransmitting TestMeasuredFreqResultLimitMargin Timin gfreqerror deg.CVolts[MHz][MHz][ppm][+/- ppm][ppm] Power o n611.0001580.0001580.262.502.24 on 2min.611.0001480.0001480.242.502.26 on 5min.611.0001540.0001540.252.502.25 on 10min.611.0001720.0001720.282.502.22 Power o n611.0002680.0002680.442.502.06 on 2min.611.0002600.0002600.432.502.07 on 5min.611.0002590.0002590.422.502.08 on 10min.611.0002830.0002830.462.502.04 Power o n----- on 2min.----- on 5min.----- on 10min.----- Power o n----- on 2min.----- on 5min.----- on 10min.----- Power o n610.999790-0.000210-0.342.502.16 on 2min.610.999801-0.000199-0.332.502.17 on 5min.610.999803-0.000197-0.322.502.18 on 10min.610.999813-0.000187-0.312.502.19 Power o n611.0000810.0000810.132.502.37 on 2min.611.0000680.0000680.112.502.39 on 5min.611.0000650.0000650.112.502.39 on 10min.611.0000580.0000580.092.502.41 Power o n611.0002680.0002680.442.502.06 on 2min.611.0002600.0002600.432.502.07 on 5min.611.0002590.0002590.422.502.08 on 10min.611.0002830.0002830.462.502.04 Power o n611.0003760.0003760.622.501.88 on 2min.611.0003930.0003930.642.501.86 on 5min.611.0003900.0003900.642.501.86 on 10min.611.0004080.0004080.672.501.83 Power o n----- on 2min.----- on 5min.----- on 10min.----- Power o n----- on 2min.----- on 5min.----- on 10min.----- Power o n----- on 2min.----- on 5min.----- on 10min.----- Limit :611 MHz +/-0.00025 % (+/- 2.5ppm) = +/- 0.001528MHz *The test on 50deg.C., 0deg.C., -10deg.C., and -20deg.C. were not apply, since the specification of operating temperature of EUT was 10deg.C to 40deg.C. Frequency Stability Test Condition 20deg.C 0.9V (Vmin) 1.5V (Vnom) 50deg.C. 1.5V 40deg.C. 30deg.C. 20deg.C. 10deg.C. 0deg.C. -10deg.C. -20deg.C UL Japan, Inc. Shonan EMC Lab. 1-22-3 Megumigaoka, Hiratsuka-shi, Kanagawa 259-1220 JAPAN Telephone : +81 463 50 6400 Facsimile : +81 463 50 6401 FCC ID : DV8LX7120 Test Report No. :30JE0026-YK-01 Page :16/ 28 Issued date : June 29, 2010 Test placeUL Japan, Inc. Shonan EMC Lab. No.5 Shielded Room Date2010/6/18 Temperature / Humidit y23deg.C., 53% Enginee rAkio Hayashi ModeTransmitting TestMeasuredFreqResultLimitMargin Timin gfreqerror deg.CVolts[MHz][MHz][ppm][+/- ppm][ppm] Power o n613.9876220.0001220.202.502.30 on 2min.613.9876100.0001100.182.502.32 on 5min.613.9876070.0001070.172.502.33 on 10min.613.9876020.0001020.172.502.33 Power o n613.9878050.0003050.502.502.00 on 2min.613.9877470.0002470.402.502.10 on 5min.613.9877580.0002580.422.502.08 on 10min.613.9878080.0003080.502.502.00 Power o n----- on 2min.----- on 5min.----- on 10min.----- Power o n----- on 2min.----- on 5min.----- on 10min.----- Power o n613.987282-0.000218-0.362.502.14 on 2min.613.987292-0.000208-0.342.502.16 on 5min.613.987312-0.000188-0.312.502.19 on 10min.613.987280-0.000220-0.362.502.14 Power o n613.9875900.0000900.152.502.35 on 2min.613.9875510.0000510.082.502.42 on 5min.613.9875690.0000690.112.502.39 on 10min.613.9875650.0000650.112.502.39 Power o n613.9878050.0003050.502.502.00 on 2min.613.9877470.0002470.402.502.10 on 5min.613.9877580.0002580.422.502.08 on 10min.613.9878080.0003080.502.502.00 Power o n613.9879470.0004470.732.501.77 on 2min.613.9879300.0004300.702.501.80 on 5min.613.9879410.0004410.722.501.78 on 10min.613.9879440.0004440.722.501.78 Power o n----- on 2min.----- on 5min.----- on 10min.----- Power o n----- on 2min.----- on 5min.----- on 10min.----- Power o n----- on 2min.----- on 5min.----- on 10min.----- Limit :613.9875 MHz +/-0.00025 % (+/- 2.5ppm) =+/- 0.001535 MH z *The test on 50deg.C., 0deg.C., -10deg.C., and -20deg.C. were not apply, since the specification of operating temperature of EUT was 10deg.C to 40deg.C. 50deg.C. …

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Test report No. : 30JE0026-YK-01 Page : 11 of 28 Issued date : June 29, 2010 FCC ID : DV8LX7120 UL Japan, Inc. SHONAN EMC LAB. 1-22-3 Megumigaoka, Hiratsuka-shi, Kanagawa-ken 259-1220 JAPAN Telephone: +81 463 50 6400 Facsimile: +81 463 50 6401 APPENDIX 1: Photographs of test setup Radiated emissions Front Rear (Below 1GHz) Rear (Above 1GHz) Test report No. : 30JE0026-YK-01 Page : 12 of 28 Issued date : June 29, 2010 FCC ID : DV8LX7120 UL Japan, Inc. SHONAN EMC LAB. 1-22-3 Megumigaoka, Hiratsuka-shi, Kanagawa-ken 259-1220 JAPAN Telephone: +81 463 50 6400 Facsimile: +81 463 50 6401 Pre-check of the worst position (Main body) X-axis Y-axis Z-axis Test report No. : 30JE0026-YK-01 Page : 13 of 28 Issued date : June 29, 2010 FCC ID : DV8LX7120 UL Japan, Inc. SHONAN EMC LAB. 1-22-3 Megumigaoka, Hiratsuka-shi, Kanagawa-ken 259-1220 JAPAN Telephone: +81 463 50 6400 Facsimile: +81 463 50 6401 Pre-check of the worst position (Antenna) X-axis Y-axis