DV8LX7120GECG & Respiration Transmitter

ECG & Respiration Transmitter LX-7120(G) Operation Manual ● Before using this equipment, 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 equipment 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 © 2015 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 Thank you for purchasing this product. Before using this product, 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 equipment 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. ii Graphic Symbols Refer to the following symbols indicated on the LX-7120(G) for their meanings. Symbols indicated on the main unit Symbol Description Caution: Refer To Accompanying Documents Indicates the need to refer to the related accompanying documents 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. No Alarm Function Indicates no alarm function. Battery Type and Direction Indicates the battery type and direction. Symbols indicated on the LCD screen Symbol Description Heart Rate Synchronization Mark This mark flashes synchronizing to the heartbeat. Battery Mark Indicates the remaining battery level. iii Precautions for Safe Operation of Medical Electrical Equipment Cautions described here are regarding the general instructions for safety use to the patient and users. As for cautions about the LX-7120(G), 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 evolved. 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 detaching the electrode, in the safest way for the patient.  Do not allow the patient to come in contact with other equipments. iv 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 equipment or an explosion from the battery may occur…

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External Photo Front Rear To p Bottom Left Right

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Test report No. : 10939078S Page : 2 of 32 Issued date : October 9, 2015 FCC ID : DV8LX7120G 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 REVISION HISTORY Original Test Report No.: 10939078S Revision Test report No. Date Page revised Contents -(Original) 10939078S October 9, 2015 - - 1 10939078S October 19, 2015 p.1, p.2 Revised page. p.4 Error correction ("±2 dBm" -> "±2 dB", "RF output power (E.I.R.P.)" -> "RF output power") p.8, p.12-p.17 Added -30 deg.C measured data, and added comment. Revised date : October 19, 2015 Test report No. : 10939078S Page : 3 of 32 Issued date : October 9, 2015 FCC ID : DV8LX7120G 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 ........................................................................................ 4 SECTION 2: Equipment under test (E.U.T.) .......................................................................... 4 SECTION 3: Test specification, procedures & results ........................................................... 5 SECTION 4: Operation of E.U.T. during testing .................................................................... 7 SECTION 5: Bandwidth & Occupied bandwidth (99%) ....................................................... 8 SECTION 6: Frequency stability .............................................................................................. 8 SECTION 7: Field strength of fundamental emission and spurious emissions .................... 9 Contents of APPENDIXES ....................................................................................................... 11 APPENDIX 1: Data of Radio tests .......................................................................................... 12 APPENDIX 2: Test instruments ............................................................................................. 30 APPENDIX 3: Photographs of test setup ............................................................................... 31 Test report No. : 10939078S Page : 4 of 32 Issued date : October 9, 2015 FCC ID : DV8LX7120G 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 Numbe r : +81-3-5684-1480 Facsimile Numbe r : +81-3-5684-1449 Contact Person : Yoshi Muraki SECTION 2: Equipment under test (E.U.T.) 2.1 Identification of E.U.T. Type of equipmen t : ECG & Respiration Transmitter Model No. : LX-7120(G) Serial No. : Refer to Clause 4.2 Rating : DC 1.5 V (Battery) Country of Mass- production : Japan 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. Receipt Date of Sample : September 7, 2015 2.2 Product description Model: LX-7120(G) (referred to as the EUT in this report) is ECG & Respiration Transmitter. Clock frequency(ies) in the system : 8 MHz, 84 kHz (Not Radio part), 13.0 MHz (Radio part, TCXO) Radio specification: Radio Type : Transmitter Frequency of Operation : 1395.0375 MHz to 1399.9625 MHz, 1427.0375 MHz to 1431.4625 MHz Modulation : DFSK RF Output Power : 5 mW ±2 dB *1) RF Output Power Limit : 740 mV/m at 3m ( = 117.3 dBuV/m at 3 m) Antenna type : Dielectric antenna Antenna gain : -13 dBi Operating Temperature : +10 deg. C. to +40 deg. C. Frequency stability : +/-2.5 ppm ITU code (Emission designator) : F1D *1) RF Output Power is fixed as shown in "08 (Confidential) Theory of Operation.pdf" and this product is shipped. (* maximum measurement value was 0.26 mW. refer to APPENDIX 1 (p.20 to p.26).) Supplied voltage: The EUT is a battery-operated device and test was performed with the new battery. Therefore, the EUT complies with power supply regulation. Revised date : October 19, 2015 Test report No. : 10939078S Page : 5 of 32 Issued date : October 9, 2015 FCC ID : DV8LX7120G 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 & results 3.1 Test specification Test specification : FCC Part 95 Subpart H: 2015, final revised on September 8, 2015 Title : FCC 47CFR Part 95 Personal Radio Services Subpart H Wireless Medical Telemetry Service (WMTS) Test specification : FCC Part 2 Subpart J: 2015, final revised on September 8, 2015 Title : FCC 47CFR Part 2 Frequency Allocations and Radio Treaty Matters; General Rules and Regulations Subpart J Equipment Authorization Procedures The EUT is used for the purpose of being related with medical treatment. Therefore this device applies to §15.103(e), exempted from FCC Part 15 Subpart B. 3.2 Procedures & Results Item Test Procedure Specification Remarks Deviation Worst margin Results Field strength of fundamental emission FCC 2.1046, ANSI/TIA-603-D: 2010 FCC 95.1115 (a) Radiated N/A 28.0 dB 1431.4625 MHz Horizontal, AV Tx 1431.4625 MHz Complied Field strength of spurious emissions FCC 2.1053, ANSI/TIA-603-D: 2010 FCC 95.1115 (b) Radiated N/A 0.4 dB 2790.075 MHz Horizontal, AV Tx 1395.0375 MHz Complied Frequency stability FCC 2.1055, ANSI/TIA-603-D: 2010 FCC 95.1115 (e) Radiated N/A - Complied Bandwidth FCC 2.1049, ANSI/TIA-603-D: 2010 Applicant specification Radiated N/A - Complied Spurious emission at antenna terminals FCC 2.1051, ANSI/TIA-603-D: 2010 - Conducted N/A *1) - - Note: UL Japan, Inc.’s EMI Work Test Procedure 13-EM-W0420. *1) The test is not applicable since the EUT has no antenna terminals. 3.3 Addition to standard No addition, exclusion nor deviation has been made from the standard. Test report No. : 10939078S Page…

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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 3: Photographs of test setup Radiated emission (Front) (Rear, below 1GHz) (Rear, above 1GHz) Test Report No. : 10939078S 31 of 32 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 X-axis Y-axis Z-axis END OF REPORT Test Report No. : 10939078S 32 of 32