DV8HLX801TM XMTR Module

TM XMTR Module HLX-801 Operation Manual ● Before using this device, read this manual thoroughly. ● Store this manual near the deivce where it can be always referred. 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 © 2011 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 the HLX-801 telemetry transmission module from Fukuda Denshi. Before use, read this operation manual thoroughly for correct handling and operation. Safety Precautions The safety precautions shown in this manual contain important details on the safe use of this product, and must be obeyed. 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, serious injury, or complete failure of the equipment. WARNING Failure to follow this message may result in death or serious injury, or complete failure of the equipment. CAUTION Failure to follow this message may cause injury or failure of 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 HLX-801. Precaution from Fukuda Denshi Fukuda Denshi is liable for the safety, reliability, and performance of its equipment. 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 for the meaning of the symbol indicated on the equipment. Symbols indicated on the main unit of the HLX-801 Symbol Description Caution; refer to accompanying documents Indicates the need to refer to related accompanying documents before operation. Refer to accompanying documents Indicates the need to refer to related accompanying documents before operation. Year of Manufacture Indicates the manufactured year. WEEE (Waste Electrical and Electronics Equipment) Indicates a separate collection for electrical and electronic equipment. 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. For cautions about the HLX-801, refer to the following pages. CAUTION 1. Do not use the equipment unless you are familiar with its operation. 2. Pay attention to the following when installing or storing the equipment. y Install or store in a place where the equipment will not be exposed to splashing water. y Store in a place where the device will not be adversely affected by atmospheric pressure, temperature, humidity, ventilation, sunlight, dust or atmosphere containing salt or sulfur. y Prevent inclination, vibration, or shock (including during transportation). y Do not install or store in an area where chemicals are stored or gasses are evolved. 3. Precautions before Operation y Check the cable connection and polarity to ensure safe and proper operation of the equipment. y Make sure that all cables are correctly and safely connected. Especially, recheck the attachment and connection condition of electrodes and transducers. y Pay special attention when the equipment is used in conjunction with other equipment because it may cause erroneous judgment and danger. y Check the remaining battery level. When replacing the battery, make sure that the battery polarity is correct. Do not charge the battery. 4. Precautions during Operation y Make sure the time required for diagnosis, or medical care is not exceeded. y Do not pick up or swing the equipment pulling the probe or cable. It may damage the equipment and lead to measurement error. y Always observe the device and patient to ensure safe operation of the equipment. y If any abnormality is found on the equipment or patient, take appropriate measures such as ceasing operation of the equipment or detaching the sensor or electrode in the safest way for the patient. y Prevent patients from touching the equipments or other electric apparatus. iv CAUTION 5. Cares after Operation y Return all operating switches or knobs to the position before using the equipment, and then switch off the power. y When unplugging the cables, do not apply excessive force by pulling on the cable. Pull from the connector part of the cable. y Clean the accessories and cables, and keep them together in one place. y Keep the equipment clean to ensure proper operation for the next use. y Make sure to remove the batteries if the equipment is not used for a long time. The leakage from the batteries may damage the equipment, or an explosion from the batteries may occur. 6. If the equipment gets out of order, immediately turn off the equipment and ensure patient safety by disconnecting electrodes and cables from the patie…

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External Photo Front Rear Antenna To p Bottom Left Right

Label location

Internal Photo 1

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 Applicant: FUKUDA DENSHI CO., LTD. Type of Equipment : TM XM TR M odule Model No. : HLX-801 FCC ID: DV8HLX801 FUKUDA DENSHI CO., LTD. declares that Model : TM XMTR Module complies with FCC radiation exposure requirement specified in the FCC Rules 2.1091. The “HLX-801“ has 0.91 mW of conducted Peak Output power and 1.49 mW of EIRP. This equipment is considered as a mobile device so that SAR testing is excluded. The Following calculation is the reference data for 20cm distance. *Since the EUT is actually fixed at the back of the host equipment(M ain Unit: DSC-8530) with a screw. RF Exposure Calculations: The following information provides the minimum separation distance for the highest gain antenna provided with the “HLX-801“ as calculated from FCC OET Bulletin 65 Appendix A, Table (B) Limits for General Population / Uncontrolled Exposure. This calculation is based on the highest EIRP possible from the system, considering maximum power and antenna gain, and considering a 0.41mW/cm^2 uncontrolled exposure limit. The Friis formula used was: S = (P * G) / (4* π * r 2 ) W here P =0.91 mW (M aximum peak output power) G = 1.64 Numerical Antenna gain; equal to2.14 dBi r =20.0 cm For: HLX-801S =0.00030mW/cm 2 No. : 32CE0136-SH-01-A RF Exposure / SAR Statement

Test report No. : 32CE0136-SH-01-A Page : 2 of 34 Issued date : December 19, 2011 FCC ID : DV8HLX801 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: Conducted emission ........................................................................................ 8 SECTION 6: Field Strength (Fundamental Emission & Out of band emissions) ............... 9 SECTION 7: Frequency Stability ....................................................................................... 11 SECTION 8: Bandwidth & Occupied bandwidth (99%) .................................................. 11 SECTION 9: Spurious emissions at antenna terminals ..................................................... 11 Contents of APPENDIXES ................................................................................................... 12 APPENDIX 1: Data of Radio tests ..................................................................................... 13 APPENDIX 2: Test instruments ........................................................................................ 31 APPENDIX 3: Photographs of test setup ........................................................................... 32 Test report No. : 32CE0136-SH-01-A Page : 3 of 34 Issued date : December 19, 2011 FCC ID : DV8HLX801 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 : +81-3-5684-1300 Facsimile Number : +81-3-5684-1480 Contact Person : Yasuhiro Yonekawa SECTION 2: Equipment under test (E.U.T.) 2.1 Identification of E.U.T. Type of Equipment : TM XMTR Module Model No. : HLX-801 Serial No. : Refer to Section 4.2 Rating : DC 5V Country of Mass-production : Japan Receipt Date of Sample : November 9, 2011 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: HLX-801, referred to as the EUT in this report, is the TM XMTR Module. General Specification Clock frequency(ies) in the system : (No Radio part) Gate Array:84kHz CPU: 18.432MHz (Radio part) TCXO: 19.2MHz Radio Specification ITU code (Emission designator) : 7K45F1D Radio Type : Transmitter Frequency of Operation : 608.0125 through 613.9875MHz Modulation : Digital Frequency Shift Keying RF Output Power (E.I.R.P.) : 1mW±2dBm *1) RF Output Power Limit : 200mV/m at 3m ( = 106dBuV/m at 3m ) Power Supply (Radio part) : DC 3.0V Antenna type : Whip Antenna Antenna Gain : 2.14dBi or below 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 (DC3.0V), therefore, the equipment complies power supply regulation. Revised date : February 29, 2012 Test report No. : 32CE0136-SH-01-A Page : 4 of 34 Issued date : December 19, 2011 FCC ID : DV8HLX801 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: 2011, final revised on November 2, 2011 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 SpecificationRemarksDeviationWorst Margin Results (Reference) Conducted emissions FCC part 15, ANSI C63.4:2003 7. AC powerline conducted emission measurements FCC part 15 Section 15.207 (July 8, 2011) - N/A 0.2dB (N, AV, Tx 0.495MHz) Complied *1) Field Strength of Fundamental Emission FCC Section 2.1046, ANSI/TIA-603-C:2004 FCC Section 95.1115(a)(1) Radiated/ Conducted N/A 10.0dB (Horizontal, QP Tx 613.9875MHz) Complied Field Strength of Out of band emissions FCC Section 2.1053, ANSI/TIA-603-C:2004 FCC Section 95.1115(b)(1)(2) RadiatedN/A 2.0dB (614MHz, Horizontal, QP Tx 613.9875MHz) 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.13-EM-W0420. *1), The conducted emissions test as FCC part 15 subpart C (2011) was measured for reference. 3.3 Addition to standard No addition, deviation or exclusion has been made from standards. Revised date : February 29, 2012 Test report No. : 32CE0136-SH-01-A Page : 5 of 34 Issued date : December 19, 2011 FCC ID : DV8HLX801 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 hav…

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DATA OF CONDUCTED EMISSION TEST UL Japan, Inc. Shonan EMC Lab. No.3 Shielded Room Date : 2011/11/10 Company: FUKUDA DENSHI CO., LTD.Mode: Transmitting 608.0125MHz Kind of EUT: TM XMTR ModuleReport No.: 32CE0136-SH-01-A Model No.: HLX-801Power: AC120V / 60Hz Serial No.: 1Temp./Humi.: 24deg.C / 36%RH Remarks: - Limit1 : FCC 15C(15.207) QP Limit2 : FCC 15C(15.207) AVEngineer:: Akio Hayashi Calculation:Result[dBuV]=Reading[dBuV]+C.Fac(LISN+Cable+HighPassFilter)[dB] LISN：SLS-03 Limit1(QP) Limit2(AV) N(PK) N(QP/AV) L1(PK) L1(QP/AV) Frequency [MHz] RFI Voltage [dBuV] .1530 .2.3.5.7123571020 0 10 20 30 40 50 60 70 80 90 100 110 No. Freq. ReadingReading C.Fac ResultsResultsLimitLimitMarginMargin PhaseCommentNo. Freq. <QP><AV> C.Fac <QP><AV><QP><AV><QP><AV>PhaseCommentNo. [MHz][dBuV][dBuV][dB][dBuV][dBuV][dBuV][dBuV][dB][dB] PhaseComment 10.2490034.634.612.547.147.161.751.714.64.6N 20.4950034.133.212.646.745.856.046.09.30.2N 30.8660031.831.912.644.444.556.046.011.61.5N 41.1120032.527.912.645.140.556.046.010.95.5N 51.6070028.426.612.641.039.256.046.015.06.8N 61.8646431.231.112.743.943.856.046.012.12.2N 72.5940032.232.212.744.944.956.046.011.11.1N 82.8420032.031.812.744.744.556.046.011.31.5N 90.2470036.136.112.548.648.661.851.813.23.2L1 100.4950033.931.612.646.544.256.046.09.51.8L1 110.8671731.831.812.644.444.456.046.011.61.6L1 121.1140032.126.912.644.739.556.046.011.36.5L1 131.6080031.629.712.644.242.356.046.011.83.7L1 141.8646432.930.112.745.642.856.046.010.43.2L1 152.5960032.532.412.745.245.156.046.010.80.9L1 162.8285230.730.512.743.443.256.046.012.62.8L1 13 of 34 DATA OF CONDUCTED EMISSION TEST UL Japan, Inc. Shonan EMC Lab. No.3 Shielded Room Date : 2011/11/10 Company: FUKUDA DENSHI CO., LTD.Mode: Transmitting 611.0000MHz Kind of EUT: TM XMTR ModuleReport No.: 32CE0136-SH-01-A Model No.: HLX-801Power: AC120V / 60Hz Serial No.: 1Temp./Humi.: 24deg.C / 36%RH Remarks: - Limit1 : FCC 15C(15.207) QP Limit2 : FCC 15C(15.207) AVEngineer:: Akio Hayashi Calculation:Result[dBuV]=Reading[dBuV]+C.Fac(LISN+Cable+HighPassFilter)[dB] LISN：SLS-03 Limit1(QP) Limit2(AV) N(PK) N(QP/AV) L1(PK) L1(QP/AV) Frequency [MHz] RFI Voltage [dBuV] .1530 .2.3.5.7123571020 0 10 20 30 40 50 60 70 80 90 100 110 No. Freq. ReadingReading C.Fac ResultsResultsLimitLimitMarginMargin PhaseCommentNo. Freq. <QP><AV> C.Fac <QP><AV><QP><AV><QP><AV>PhaseCommentNo. [MHz][dBuV][dBuV][dB][dBuV][dBuV][dBuV][dBuV][dB][dB] PhaseComment 10.2447734.734.712.547.247.261.951.914.74.7N 20.4930033.633.112.646.245.756.146.19.90.4N 30.8662631.731.312.644.343.956.046.011.72.1N 41.1110031.826.912.644.439.556.046.011.66.5N 51.2320028.627.812.641.240.456.046.014.85.6N 61.4883228.828.712.641.441.356.046.014.64.7N 71.8490031.931.812.744.644.556.046.011.41.5N 81.9730029.026.812.741.739.556.046.014.36.5N 92.2190033.632.812.746.345.556.046.09.70.5N 102.5539931.931.612.744.644.356.046.011.41.7N 110.2470036.536.012.549.048.561.851.812.83.3L1 120.4930030.730.412.643.343.056.146.112.83.1L1 130.8640031.832.012.644.444.656.046.011.61.4L1 141.1100031.726.912.644.339.556.046.011.76.5L1 151.2340031.631.712.644.244.356.046.011.81.7L1 161.4883230.227.312.642.839.956.046.013.26.1L1 171.8510032.929.212.745.641.956.046.010.44.1L1 181.9740028.728.512.741.441.256.046.014.64.8L1 192.2120432.132.112.744.844.856.046.011.21.2L1 202.5900032.732.612.745.445.356.046.010.60.7L1 14 of 34 DATA OF CONDUCTED EMISSION TEST UL Japan, Inc. Shonan EMC Lab. No.3 Shielded Room Date : 2011/11/10 Company: FUKUDA DENSHI CO., LTD.Mode: Transmitting 613.9875MHz Kind of EUT: TM XMTR ModuleReport No.: 32CE0136-SH-01-A Model No.: HLX-801Power: AC120V/60Hz Serial No.: 1Temp./Humi.: 24deg.C / 36%RH Remarks: - Limit1 : FCC 15C(15.207) QP Limit2 : FCC 15C(15.207) AVEngineer:: Akio Hayashi Calculation:Result[dBuV]=Reading[dBuV]+C.Fac(LISN+Cable+HighPassFilter)[dB] LISN：SLS-03 Limit1(QP) Limit2(AV) N(PK) N(QP/AV) L1(PK) L1(QP/AV) Frequency [MHz] RFI Voltage [dBuV] .1530 .2.3.5.7123571020 0 10 20 30 40 50 60 70 80 90 100 110 No. Freq. ReadingReading C.Fac ResultsResultsLimitLimitMarginMargin PhaseCommentNo. Freq. <QP><AV> C.Fac <QP><AV><QP><AV><QP><AV>PhaseCommentNo. [MHz][dBuV][dBuV][dB][dBuV][dBuV][dBuV][dBuV][dB][dB] PhaseComment 10.2450035.135.012.547.647.561.951.914.34.4N 20.4930033.433.212.646.045.856.146.110.10.3N 30.8620031.832.012.644.444.656.046.011.61.4N 41.1070032.127.612.644.740.256.046.011.35.8N 51.2310028.127.812.640.740.456.046.015.35.6N 61.6010028.226.612.640.839.256.046.015.26.8N 71.8470031.431.312.744.144.056.046.011.92.0N 82.2160033.433.012.746.145.756.046.09.90.3N 92.5840032.232.112.744.944.856.046.011.11.2N 102.8280030.930.912.743.643.656.046.012.42.4N 110.2470035.735.612.548.248.161.851.813.63.7L1 120.4930030.930.712.643.543.356.146.112.62.8L1 130.8640032.031.812.644.644.456.046.011.41.6L1 141.1090031.426.512.644.039.156.046.012.06.9L1 151.2310031.631.712.644.244.356.046.011.81.7L1 161.6010031.629.712.644.242.356.046.011.83.7L1 171.8460033.729.612.746.442.356.046.09.63.7L1 182.2140031.631.212.744.343.956.046.011.72.1L1 192.5840032.532.412.745.245.156.046.010.80.9L1 202.8300030.229.912.742.942.656.046.013.13.4L1 15 of 34 Test placeUL Japan, Inc. Shonan EMC Lab. No.5 Shielded Room Date2011/11/10 Temperature / Humidity 24deg.C.52%RH EngineerAkio Hayashi ModeTransmitting TestMeasuredFrequencyResultLimitMargin Timin gfrequencyerror deg.CVolts.[MHz][MHz][ppm][+/- ppm][ppm] Power o n----- on 2min.----- on 5min.----- on 10min.----- Power o n608.012295-0.000205-0.342.502.16 on 2min.608.012296-0.000204-0.342.502.16 on 5min.608.012297-0.000203-0.332.502.17 on 10min.608.012298-0.000202-0.332.502.17 Power o n608.012362-0.000138-0.232.502.27 on 2min.608.012358-0.000142-0.232.502.27 on 5min.608.012350-0.000150-0.252.502.25 on 10min.608.012347-0.000153-0.252.502.25 Power o n608.012418-0.000082-0.132.502.37 on 2min.608.012420-0.000080-0.132.502.37 on 5min.608.012418-0.000082-0.132.502.37 on 10min.608.012417-0.000083-0.142.502.36 Power o n608.012390-0.000110-0.182.502.32 on 2min.608.012397-0.000103-0.172.…

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Test report No. : 32CE0136-SH-01-A Page : 32 of 34 Issued date : December 19,2011 FCC ID : DV8HLX801 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 Conducted emission Test report No. : 32CE0136-SH-01-A Page : 33 of 34 Issued date : December 19,2011 FCC ID : DV8HLX801 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 Radiated emission Front Below 1GHz Above 1GHz Test report No. : 32CE0136-SH-01-A Page : 34 of 34 Issued date : December 19,2011 FCC ID : DV8HLX801 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 Module:X-axis / Antenna:X-axis Module:X-axis / Antenna:Y-axis Module:Y-axis / Antenna:X-axis Module:Y-axis / Antenna:Y-axis Module:Z-axis / Antenna:X-axis Module:Z-axis / Antenna:Y-axis