VUOTMS6016Telemetry Monitoring Transmitter

TMS-6016 Telemetry Monitoring System Operation Manual I CE Marking The telemetry monitoring system bears CE mark indicating its conformity with the provisions of the Council Directive 93/42/EEC concerning medical devices and fulfils the essential requirements of Annex I of this directive. The telemetry monitoring system is in radio-interference protection class B in accordance with EN55011. The product complies with the requirement of standard EN60601-1-2 “Electromagnetic Compatibility – Medical Electrical Equipment”. Revision History This manual has a revision number. This revision number changes whenever the manual is updated due to software or technical specification change. Contents of this manual are subject to change without prior notice. Revision 1.0 is the initial release of the document. „ Version number: 2.1 „ Release time: November 2006 © 2005 - 2006 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. All rights reserved. WARNING z Federal Law (USA) restricts this device to sale by or on the order of a physician. II Intellectual Property Statement SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. (hereinafter called Mindray) owns the intellectual property rights to this product and this manual. This manual may refer to information protected by copyrights or patents and does not convey any license under the patent rights of Mindray, nor the rights of others. Mindray does not assume any liability arising out of any infringements of patents or other rights of third parties. Mindray intends to maintain the contents of this manual as confidential information. Disclosure of the information in this manual in any manner whatsoever without the written permission of Mindray is strictly forbidden. Release, amendment, reproduction, distribution, rent, adaption and translation of this manual in any manner whatsoever without the written permission of Mindray is strictly forbidden. and are the registered trademarks or trademarks owned by Mindray in China and other countries. All other trademarks that appear in this manual are used only for editorial purposes without the intention of improperly using them. They are the property of their respective owners. Contents of this manual are subject to changes without prior notice. III Manufacturer’s Responsibility All information contained in this manual is believed to be correct. Mindray shall not be liable for errors contained herein nor for incidental or consequential damages in connection with the furnishing, performance, or use of this manual. Mindray is responsible for safety, reliability and performance of this product only in the condition that: „ All installation operations, expansions, changes, modifications and repairs of this product are conducted by Mindray authorized personnel; and „ The electrical installation of the relevant room complies with the applicable national and local requirements; and „ This product is operated under strict observance of this manual. Warranty This warranty is exclusive and is in lieu of all other warranties, expressed or implied, including warranties of merchantability or fitness for any particular purpose. Exemptions Mindray's obligation or liability under this warranty does not include any transportation or other charges or liability for direct, indirect or consequential damages or delay resulting from the improper use or application of the product or the use of parts or accessories not approved by Mindray or repairs by people other than Mindray authorized personnel. This warranty shall not extend to „ Any Mindray product which has been subjected to misuse, negligence or accident; or „ Any Mindray product from which Mindray's original serial number tag or product identification markings have been altered or removed; or „ Any product of any other manufacturer. IV Return Policy In the event that it becomes necessary to return a unit to Mindray, follow the instructions below. 1. Obtain a return authorization. Contact the Mindray Service Department and obtain a Mindray Customer Service Authorization Number. The Mindray Customer Service Authorization Number must appear on the outside of the shipping container. Return shipments will not be accepted if the Mindray Customer Service Authorization Number is not clearly visible. Please provide the model number, serial number, and a brief description of the reason for return. 2. Freight policy The customer is responsible for freight charges when this product is shipped to Mindray for service (including any relevant customs fees or other freight related charges). 3. Return address Please send the part(s) or equipment to the address offered by Customer Service Department. Contact Information Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Address: Mindray Building, Keji 12th Road South, Hi-tech Industrial Park, Nanshan, Shenzhen 518057 P.R. China Tel: +86 755 26582479 +86 755 26582888 Fax: +86 755 26582934 +86 755 26582500 Website: www.mindray.com EC-Representative: Shanghai International Holding Corp. GmbH (Europe) Address: Eiffestraße 80, 20537 Hamburg Germany Tel: 0049-40-2513175 Fax: 0049-40-255726 V Preface Manual Purpose This manual contains the instructions necessary to operate the telemetry monitoring system safely and in accordance with its function and intended use. Observance of this manual is a prerequisite for proper product performance and correct operation and ensures patient and operator safety. This manual is based on the maximum configuration and therefore some contents may not apply to your telemetry monitoring system. If you have any question, please contact us. This manual is an integral part of the product. It should always be kept close to the equipment so that it can be obtained conveniently when needed. Intended Audience This manual is geared for clinical professionals who are expected to have a working knowledge of medical procedures, practices and terminology as required for monitoring of critically ill patients. Illustrations…

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SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD Mindray Building, Keji 12 th Road South, High-tech Industrial Park, Nanshan, Shenzhen 518057, P.R. China Phone: 86-755-26582643 Fax: 86-755-26582680 E-mail: [email protected] DECLARATION LETTER To whom it may concern: We declare that the receiver associated with this transmitting system will be performed DoC measurements at Spectrum Research & Testing Lab in Taiwan. Sincerely, Signature

Cover Letter Dec 25, 2007 Gentlemen, Please find below our responses to your Inquiry Tracking Number ATCB005749. If you require more information kindly let us know at your first available opportunity. 1. Please provide a better operational description that includes the number of channels used by this device, their frequencies and the information required by the following sections of the FCC Rules: (a) 2.1033(c )(4)-Type or types of emissions (emission designator) used by this transmitter, (b) 2.1033(c )(6)-Range of operating power values or specific operating power levels, and description of any means provided for variation of operating power, (c) 2.1033(c )(7)-Maximum power rating as defined in the applicable part(s) of the rules, and (d) 2.1033(c) (8)-The dc voltages applied to and dc currents into the several elements of the final radio frequency amplifying device for normal operation over the power range. This new operation description has been submittalled. 2. Please provide an exhibit with the tune-up procedure over the power range, or at specific operating power levels as specified in Section 2.1033(c )(9) of the Rules. The exhibit filled in the new operation description. 3. Please provide the information listed in Section 2.1033(c )(10) of the rules as part of the operational description or the schematic diagram. You need to provide a description of all circuitry and devices provided for determining and stabilizing frequency, for suppression of spurious radiation, for limiting modulation, and for limiting power. This new operation description has been submittalled. 4. Please provide output power measurements at the antenna connector as specified in Section 2.1046 of the Rules. If this transmitter does not have an antenna connector, you can calculate the output power using the formula P = (E x d)2/30G, where P is power in watts, E is maximum field strength in volts/meter, d is distance in meters, and G is the numeric gain of the transmitting antenna with reference to an isotropic radiator. The output power has been tested and recorded in test report.. 5. Please provide frequency stability measurements at – 30 degrees C as specified in Section 2.1055(a)(1) of the Rules. You only submitted frequency stability test data down to – 20 degrees C. The test has performed at -30 degrees C and recorded in test report. 6. Please provide an amended 731 application form that lists the output power from item 4 above, the frequency stability measured in item 5 above and the emission designator determined from the occupied bandwidth and type of emissions reported in item 1 above. These items were left blank on the submitted 731 application form. The new 731 form has been submittalled. 7. Radiated emission test results only show the result. They do not include any correction factors and a calculation on how the result was obtained. For example, the measured level is corrected by adding the antenna correction factor, adding the cable loss and subtracting the amplifier gain. Please provide these factors and a sample calculation in radiated test results. The factor and sample calculation have added in test report. 8. Please provide the resolution bandwidth and video bandwidth and the detector function of the measuring instrument used during radiated emission measurements above 1 GHz. The revised test report has including this information. 9. Please provide an amended equipment label that contains the statement required by Section 95.1109(b) of the Rules and show where this label will be on the equipment. The revised label has added the statement. 10. Please address RF safety of this device in accordance with Section 95.1125 of the Rules by confirming that this device complies with these requirements and provide the basis for this statement. I note that this device can be worn next to the body either by a belt around the waist or loop around the neck. The RF SAFETY has submittalled. 11. The receiver associated with this transmitting system requires either Declaration of Conformity or Certification in accordance with Section 15.101(a) of the Rules. Test labs in China are not eligible to perform DoC measurements because there is no Mutual Recognition Agreement in force between the USA and China. Please provide evidence that the proper authorization has been done. Please note that the FCC is about to enforce this new requirement on all TCBs in January of 2008. More details will follow when the FCC releases the procedures TCBs are to follow in this matter. The declaration of DoC of receiver has submittalled. 12. For Your Information – The signature on the 731 application form must be typed in English below the chop or Chinese signature that appears on the application form. Please make a note of this for future filings. Applications are required to be in the English language so I believe the signature should also either be in English or translated from Chinese to English if the Chinese signature is used. There is no any Chinese signature in 731 form. Best Regards, (Official officer of HTW)

SHENZHEN HUATONGWEI INTERNATIONAL INSPECTION CO., LTD External of EUT SHENZHEN HUATONGWEI INTERNATIONAL INSPECTION CO., LTD

The FCC ID & IC Label and Location FCC ID label location

SHENZHEN HUATONGWEI INTERNATIONAL INSPECTION CO., LTD Internal view of EUT SHENZHEN HUATONGWEI INTERNATIONAL INSPECTION CO., LTD

Tune up procedures There is no tune up procedure for the model TMS‐6016 telemetry monitoring transmitter. Please see the user manual for instructions on how to change the operating channel.

RF EXPOSURE INFO RF Safety Requirements to 2.1091/95.1125 for Mobile Transmitters Part 95 transmitters are considered categorically excluded from routine environmental evaluation as given in 47 CFR 2.1091. However, the following information is presented to prove compliance with the limits. Power Output The EUT’s maximum output power as measured from the transmitter is -5.2 dBm (ERP). The EUT antenna’s gain is -2dBi. MPE Calculations The limits for this unit (uncontrolled exposure) are 0.4 mW/cm 2 . Taking the RF Density Field Equation: S = (EIRP in mW)/ (4 R 2 ) and solving for Distance R R = SQRT (EIRP in mW)/ (S4) Solving the above equation yields R (cm) = SQRT (0.3(mw))/ (0.4(mW/cm 2 )*4*) = 0.25 cm

SHENZHEN HUATONGWEI INTERNATIONAL INSPECTION CO., LTD REPORT NO: WE07110002 FCC ID: VUOTMS6016 DATE: 12/04/2007 Pag1 Rev. 00 ELECTROMAGNETIC EMISSIONS COMPLIANCE REPORT INTENTIONAL RADIATOR CERTIFICATION TO FCC PART 95H REQUIREMENTS OF TELEMETRY MONITORING SYSTEM MODEL No.: TMS-6016 BRAND NAME: MINDRAY FCC ID: VUOTMS6016 REPORT NO: WE07110002 ISSUE DATE: Dec 04, 2007 Prepared for SHENZHEN HYT SCIENCE & TECHNOLOGY CO., LTD. HYT TOWER, SHENZHEN HI-TECH INDUSTRIAL PARK NORTH, BEIHUAN RD., NANSHAN DISTRICT, SHENZHEN, P.R.C. Prepared by SHENZHEN HUATONGWEI INTERNATIONAL INSPECTION CO., LTD d.b.a. SHENZHEN HUATONGWEI INTERNATIONAL INSPECTION CO., LTD HUATONGWEI BUILDING, KEJI RD. 12 S., HIGH-TECH PARK, NANSHAN DISTRICT, SHENZHEN, GUANGDONG, P.R.CHINA TEL: 86-755-26748099 FAX: 86-755-26748005 SHENZHEN HUATONGWEI INTERNATIONAL INSPECTION CO., LTD REPORT NO: WE07110002 FCC ID: VUOTMS6016 DATE: 12/04/2007 Pag2 Rev. 00 VERIFICATION OF COMPLIANCE Applicant: SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. Mindray Building, Keji 12 th Road South, High-tech Industrial Park, Nanshan, Shenzhen 518057, P.R. China Product Description: Telemetry Monitoring System Brand Name: MINDRAY Model Number: TMS-6016 Serial Number: N/A File Number: WE07110002 Date of Test: Nov 22, 2006 ~ Dec 02, 2006 We hereby certify that: The above equipment was tested by SHENZHEN HUATONGWEI INTERNATIONAL INSPECTION CO., LTD. The test data, data evaluation, test procedures, and equipment configurations shown in this report were made in accordance with the procedures given in ANSI C63.4 (2003), TIA/EIA 603 and the energy emitted by the sample EUT tested as described in this report is in compliance with radiated emission limits of FCC Rules Part 95 H. The test results of this report relate only to the tested sample identified in this report. Approved By Reviewed By Jimmy Li /Executive Manager Tracy Qi / RF Engineer SHENZHEN HUA TONG WEI SHENZHEN HUA TONG WEI INTERNATIONAL INSPECTION CO., LTD INTERNATIONAL INSPECTION CO., LTD Table of Contents SHENZHEN HUATONGWEI INTERNATIONAL INSPECTION CO., LTD REPORT NO: WE07110002 FCC ID: VUOTMS6016 DATE: 12/04/2007 Pag3 Rev. 00 1. GENERAL INFORMATION .................................................................................................................... 4 1.1 PROCUCT DESCRIPTION ........................................................................................................................... 4 1.2 RELATED SUBMITTSL(S) / GRANT(S) ..................................................................................................... 4 1.3 TEST METHODOLOGY ............................................................................................................................... 4 1.4 TEST FACILITY ............................................................................................................................................ 4 1.5 SPECIAL ACCESSORIES ............................................................................................................................. 4 1.6 EQUIPMENT MODIFICATIONS ................................................................................................................. 4 1.7 EQUIPENT ..................................................................................................................................................... 5 1.8 LABORATORY ACCREDITATIONS AND LISTINGS.............................................................................. 5 2. SYSTEM TEST CONFIGURATION........................................................................................................ 7 2.1 EUT CONFIGURATION ............................................................................................................................... 7 2.2 EUT EXERCISE ............................................................................................................................................. 7 2.3 SUMMARY OF TEST RESULTS ................................................................................................................. 7 2.4 CONFIGUARATION OF TESTED SYSTEM............................................................................................... 7 3 DESCRIPTION OF TEST MODES .......................................................................................................... 8 4. CONDUCTED EMISSION TEST ............................................................................................................ 9 4.1 MEASUREMENT PROCEDURE.................................................................................................................. 9 4.2 TEST SETUP BLOCK DIAGRAM................................................................................................................ 9 4.3 TEST EQUIPENT USED: ............................................................................................................................ 10 4.4 CONDUCTED POWER LINE EMISSION LIMITS ................................................................................... 10 4.5 TEST RESULTS ........................................................................................................................................... 10 5. OUTPUT POWER MEASUREMENT (ERP)......................................................................................... 11 5.1 MEASUREMENT EQUIPMENT USED ..................................................................................................... 11 5.2 MEASUREMENT METHOD ...................................................................................................................... 11 5.3 TEST RESULTS: .......................................................................................................................................... 15 6. OCCUPIED BANDWIDTH.................................................................................................................... 16 6.1 MEASUREMENT PROCEDURE........................................................…

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