ZLZ-WMTSAP70Telemetry Monitor

WMTS Access Point A P70 Mi ndray User Manual Shenzhen Mindray BIO-Medical electronics Co.,LTD. Mindray Building, Keji 12th Road South, Hi-tech Ind, Shenzhen, China Introduction TM80/TM70 Telemetry Monitor Operator's ManualI © Copyright 2019 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. All rights reserved. ■Release time: 2019-10 ■Revision: 4.0 WA RN ING •Federal Law (USA) restricts this device to sale by or on the order of a phy- sician or other practitioner licensed by U.S. state law to use or order the use of this device. Intellectual Property StatementIntroduction IITM80/TM70 Telemetry Monitor Operator's Manual Intellectual Property Statement SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. (hereinafter called Mindray) owns the intellectual property rights to this Mindray product and this manual. This man- ual 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 intends to maintain the contents of this manual as confidential information. Disclosure of the information in this manual in any manner whatsoever without the writ- ten permission of Mindray is strictly forbidden. Release, amendment, reproduction, distribution, rental, 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. This posting serves as notice under 35 U.S.C.§287(a) for Mindray patents: http:// www.mindrayna.com/patents. Manufacturer’s Responsibility Contents of this manual are subject to changes without prior notice. 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 connec- tion with the furnishing, performance, or use of this manual. Mindray is responsible for the effects on safety, reliability and performance of this prod- uct, only if: ■all installation operations, expansions, changes, modifications and repairs of this product are conducted by Mindray authorized personnel; ■the electrical installation of the relevant room complies with the applicable national and local requirements; ■the product is used in accordance with the instructions for use. IntroductionWarranty TM80/TM70 Telemetry Monitor Operator's ManualIII Warranty Mindray warrants that components within its products will be free from defects in work- manship and materials for a period of three years from the date of purchase except that disposable or one-time use products are warranted to be free from defects in workman- ship and materials up to a date one year from the date of purchase or the date of first use, whichever is sooner. This warranty does not cover consumable items such as, but not limited to, batteries, external cables, and sensors. Mindray shall not be liable for any incidental, special, or consequential loss, damage, or expense directly or indirectly arising from the use of its products. Liability under this warranty and the buyer’s exclusive remedy under this warranty is limited to servicing or replacing the affected products, at Mindray option, at the factory or at an authorized dis- tributor, for any product which shall under normal use and service appear to Mindray to have been defective in material or workmanship. Recommended preventative mainte- nance, as prescribed in the service manual, is the responsibility of the user and is not covered by this warranty. No agent, employee, or representative of Mindray has any authority to bind Mindray to any affirmation, representation, or warranty concerning its products, and any affirma- tion, representation or warranty made by any agent, employee, or representative shall not be enforceable by buyer or user. THIS WARRANTY IS EXPRESSLY IN LIEU OF, AND MINDRAY EXPRESSLY DISCLAIMS, ANY OTHER EXPRESS OR IMPLIED WARRANTIES, INCLUDING ANY IMPLIED WARRANTY OF MERCHANTABILITY, NON-INFRINGEMENT, OR FITNESS FOR A PARTICULAR PURPOSE, AND OF ANY OTHER OBLIGATION ON THE PART OF MINDRAY. Damage to any product or parts through misuse, neglect, accident, or by affixing any non-standard accessory attachments, or by any customer modification voids this war- ranty. Mindray makes no warranty whatsoever in regard to trade accessories, such being subject to the warranty of their respective manufacturers. A condition of this warranty is that the equipment or accessories which are claimed to be defective be returned when authorized, freight prepaid to Mindray DS USA, Inc., Mah- wah, New Jersey 07430 or its authorized representative. Mindray shall not have any responsibility in the event of loss or damage in transit. WARNING •Only skilled/trained clinical professionals should operate this equipment. •It is important for the hospital or organization that employs this equip- ment to carry out a reasonable service/maintenance plan. Neglect of this may result in machine breakdown or personal injury. Company ContactIntroduction IVTM80/TM70 Telemetry Monitor Operator's Manual 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 result- ing 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 does not extend to: ■Malfunction or damage caused by improper use or man-made failure. ■Malfunction or damage caused by unstable or out-of-range power input. ■Malfunction or damage caused by force majeure events, such as (i) flood, fire and earthquake or other similar elements of nature or …

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AlarmsResetting Alarms TM80/TM70 Telemetry Monitor Operator’s Manual6 - 9 The alarm pause time is two minutes. When the pause time expires, the alarm paused status is automatically deactivated. You can also cancel the alarm paused status by tapping [ Alarm Pause] in the quick keys area. 6.9Resetting Alarms You can acknowledge the on-going alarms by resetting the alarms. After being reset, the alarm reset symbol is displayed in the message area. When an alarm occurs, follow this procedure to reset the TM80/TM70’s alarm system. ■Press the key to enter the main menu, and then tap [Alarm Reset] from the [Commands] section. OR 1.Flick your finger up at the bottom of the main screen to display the quick keys area. 2.Tap the [Alarm Reset] quick key to reset the alarm system. 6.9.1Resetting Physiological Alarms After the alarm system is reset, physiological alarms give the following alarm indicators: ■The alarm sound is silenced. ■The symbol appears in the message area. NOTE •When the TM80/TM70 is connected to the CMS and the function of remotely pausing alarms is enabled at the CMS, alarms can be paused either at the TM80/TM70 or at the CMS. For information on pausing alarms at the CMS, refer to BeneVision Central Monitoring System Opera- tor’s Manual. NOTE •When the TM80/TM70 is connected to the CMS and the function of remotely resetting alarms is enabled at the CMS, alarms can be reset either at the TM80/TM70 or at the CMS. For information on resetting alarms at the CMS, refer to BeneVision Central Monitoring System Opera- tor’s Manual. Latching AlarmsAlarms 6 - 10TM80/TM70 Telemetry Monitor Operator’s Manual ■A √ mark appears before the alarm message, indicating that the alarm is acknowledged. ■The color of the parameter numeric background corresponds with the alarm priority, but the parameter numeric does not flash. 6.9.2Resetting Technical Alarms After the alarm system is reset, technical alarms give the following alarm indicators: ■The symbol appears in the message area. ■Some technical alarms are cleared and no alarm indications are given. ■Some technical alarms are changed to prompt messages. ■For some technical alarms, the alarm sound will be silenced, the alarm light will continue to indicate the alarm, a √ markwill appear before the alarm message. For details about the indications of technical alarms when the alarm system is reset, refer to "Technical Alarm Messages at the TM80/TM70" on page 15 - 5. 6.10Latching Alarms When physiological alarms are latched, the time when the alarm is last triggered is dis- played behind the alarm message. Besides, resetting or pausing alarms via the TM80/ TM70 or the CentralStation clears latched alarms. 6.11Actions When an Alarm Occurs When an alarm occurs, observe the following steps and take proper actions: 1.Check the patient’s condition. 2.Confirm the alarming parameter or alarm category. 3.Identify the source of the alarm. 4.Take proper action to eliminate the alarm condition. 5.Make sure the alarm condition is corrected. For more information, refer to "Troubleshooting" on page 15 - 1. NOTE •Latching settings for physiological alarms are configured at the Cen- tralStation. For more information on how to configure latching settings, refer to BeneVision Central Monitoring System Operator’s Manual (P/N 046-007960-00). TM80/TM70 Telemetry Monitor Operator’s Manual7 - 1 7Monitoring ECG Introduction............................................................................................................... 7-2 Safety............................................................................................................................ 7-2 Preparation for Monitoring ECG ......................................................................... 7-3 Changing the ECG Settings .................................................................................. 7-12 Configuring the HR Alarm Source...................................................................... 7-16 Understanding the ECG Display ......................................................................... 7-17 ST Monitoring............................................................................................................ 7-18 QT/QTc Interval Monitoring..................................................................................7-21 Arrhythmia Monitoring..........................................................................................7-24 Relearning...................................................................................................................7-34 IntroductionMonitoring ECG 7 - 2TM80/TM70 Telemetry Monitor Operator’s Manual 7.1Introduction The electrocardiogram (ECG) measures the electrical activity of the heart and displays it on the monitor as a waveform and a numeric. ECG monitoring provides 3-, 5-, and 6-lead ECG monitoring, ST-segment analysis, arrhythmia analysis, and QT/QTc measurements. Operations such as configuring QRS threshold, adjusting ST point/ISO point/J point, set- ting ST template/QT template are performed at the CentralStation. For details about these operations, refer to Chapter 12 Monitoring with the TM80/TM70 at the CMS. 7.2Safety WA RN ING •This equipment is not suitable for direct cardiac application. •Use manufacturer specified electrodes and lead wires. •Make sure the conductive parts of electrodes and associated connectors for applied parts, including the neutral electrode, do not contact any other conductive parts including earth. •Periodically inspect the electrode application site to ensure skin quality. If the skin quality changes, replace the electrodes or change the applica- tion site. •Use defibrillation-proof ECG leadwires during defibrillation. •Do not touch the patient or any device connected to the patient, includ- ing the bed and gurney, during defibrillation. Otherwise serious injury or death could result. CAUTION •Interference from a non-grounded instrument near the patient and elec- tro-surgery interferen…

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Shenzhen Mindray BIO-Medical electronics Co.,LTD. Date: 2020-03-16 Federal Communications Commission Authorization and Evaluation Division 7435 Oakland Mills Road Columbia, MD 21046 FCC ID: ZLZ-WMTSAP70 To Whom It May Concern: This letter is to statement that AP70/ WMTS Access Point. has been tested according to FCC Part 15B by Waltek Services (Shenzhen) Co., Ltd. (Test Report No.: WTS19S09066155E). And the SDOC file, meetting the requirements of the FCC regulations, would been provided when the device is sold by the responsible party in US. The service will not be sold until the SDOC is provided. If the sale does not have an SDOC, all responsibility is the responsibility of the applicant. Sincerely, Signature [Leo Shao] [Manager] [Shenzhen Mindray BIO-Medical electronics Co.,LTD.]

Shenzhen Mindray BIO-Medical electronics Co.,LTD. Date: Mar. 16, 2020 Federal Communications Commission Authorization and Evaluation Division Confidentiality Request regarding application for certification of FCC ID: ZLZ-WMTSAP70 Pursuant to Sections 0.457 and 0.459 of the Commission’s Rules, we hereby request confidential treatment of information accompanying this application as outlined below: Exhibit Type File Name Schematics Block Diagram Operational Description Schematics.pdf Block Diagram.pdf Operational Description.pdf The above materials contain trade secrets and proprietary information not customarily released to the public. The public disclosure of these materials may be harmful to the applicant and provide unjustified benefits to its competitors. The applicant understands that pursuant to Section 0.457 of the Rules, disclosure of this application and all accompanying documentation will not be made before the date of the Grant for this application. Sincerely, Shenzhen Mindray BIO-Medical electronics Co.,LTD. Signature Leo Shao / Manager Typed name and Title

Shenzhen Mindray BIO-Medical electronics Co.,LTD. FCC ID: ZLZ-WMTSAP70 POWER OF ATTORNEY Date: Mar. 16, 2020 Federal Communications Commission Authorization and Evaluation Division 7435 Oakland Mills Road Columbia, MD 21046 To Whom It May Concern: We, the undersigned, hereby authorize Waltek Services (ShenZhen) Co., Ltd. (Philo Zhong) on our behalf, to apply to the Federal Communications Commission on our equipment. Any and all acts carried out by Waltek Services (ShenZhen) Co., Ltd. (Philo Zhong) on our behalf shall have the same effect as acts of our own. This authorization expires on Mar. 15, 2021. This is to advise that we are in full compliance with the Anti-Drug Abuse Act. We, Shenzhen Mindray BIO-Medical electronics Co.,LTD. are not subject to a denial of federal benefits pursuant to Section 5301 of the Anti-Drug Act of 1988, 21 USC853a, and no party to the application is subject to a denial of federal benefits pursuant to that section. Sincerely, Shenzhen Mindray BIO-Medical electronics Co.,LTD. Signature Leo Shao / Manager Typed name and Title

Appendix-AP70-Photos Page 2 of 15 EUT – External View Model AP70 FCC ID: ZLZ-WMTSAP70 WMTS AN T. Appendix-AP70-Photos Page 3 of 15 Appendix-AP70-Photos Page 4 of 15 Appendix-AP70-Photos Page 5 of 15 Appendix-AP70-Photos Page 6 of 15

AP70 Label Sample and Location

Appendix-AP70-Photos Page 7 of 15 EUT – Internal View Model AP70 FCC ID: ZLZ-WMTSAP70 Appendix-AP70-Photos Page 8 of 15 Appendix-AP70-Photos Page 9 of 15 Appendix-AP70-Photos Page 10 of 15

Appendix-AP70-Photos Page 11 of 15 Appendix-AP70-Photos Page 12 of 15 Appendix-AP70-Photos Page 13 of 15 Appendix-AP70-Photos Page 14 of 15 Appendix-AP70-Photos Page 15 of 15 ======End======

Reference No.: WTS19S09066153W002 Page 1 of 4 Waltek Services (Shenzhen) Co.,Ltd. http://www.waltek.com.cn 1 Test Summary Test Items Test Requirement Result Maximum Permissible Exposure (Exposure of Humans to RF Fields) 1.1307(b)(1) PASS Reference No.: WTS19S09066153W002 Page 2 of 4 2 RF Exposure Test Requirement: FCC Part 1.1307 Test Mode: The EUT work in test mode(Tx). 2.1 Requirements Systems operating under the provisions of this section shall be operated in a manner that ensures that the public is not exposed to radio frequency energy levels in excess limit for maximum permissible exposure. In accordance with 47 CFR FCC Part 2 Subpart J, section 2.1091 this device has been defined as a mobile device whereby a distance of 0.2 m normally can be maintained between the user and the device. 2.2 The procedures / limit FCC Part 1.1307: (A) Limits for Occupational / Controlled Exposure Frequency Range (MHz) Electric Field Strength (E) (V/m) Magnetic Field Strength (H) (A/m) Power Density (S) (mW/ cm 2 ) Averaging Time |E| 2 ,|H| 2 or S (minutes) 0.3-3.0 614 1.63 (100)* 6 3.0-30 1842 / f 4.89 / f (900 / f)* 6 30-300 61.4 0.163 1.0 6 300-1500 F/300 6 1500-100,000 5 6 (B) Limits for General Population / Uncontrolled Exposure Frequency Range (MHz) Electric Field Strength (E) (V/m) Magnetic Field Strength (H) (A/m) Power Density (S) (mW/ cm 2 ) Averaging Time |E| 2 ,|H| 2 or S (minutes) 0.3-1.34 614 1.63 (100)* 30 1.34-30 824/f 2.19/f (180/f)* 30 30-300 27.5 0.073 0.2 30 300-1500 F/1500 30 1500-100,000 1.0 30 Note: f = frequency in MHz ; *Plane-wave equivalent power density Reference No.: WTS19S09066153W002 Page 3 of 4 2.3 MPE Calculation Method Predication of MPE limit at a given distance S = power density (in appropriate units, e.g. mW/cm 2 ) P = power input to the antenna (in appropriate units, e.g., mW). G = power gain of the antenna in the direction of interest relative to an isotropic radiator, the power gain factor, is normally numeric gain. R = distance to the center of radiation of the antenna (appropriate units, e.g., cm) From the peak EUT RF output power, the minimum mobile separation distance, d=0.2m, as well as the gain of the used antenna, the RF power density can be obtained 608.66MHz Frequency Antenna Gain (dBi) Antenna Gain (numeric) Max.Peak Output Power (dBm) Peak Output Power (mW) Power Density (mW/cm 2 ) Limit of Power Density (mW/cm 2 ) 608.66 -1.30 0.741 9.42 8.75 0.001290 0.406 Note: the following is Source-based time-averaged maximum output power Calculation Frequency Source-based time-averaged maximum output power Substituted (0dBm) Source-based time- averaged maximum output power (MHz) (dBμV/m) (dBμV/m) (dBm) 608.66 104.62 95.2 9.42 1395.5 MHz Frequency Antenna Gain (dBi) Antenna Gain (numeric) Max.Peak Output Power (dBm) Peak Output Power (mW) Power Density (mW/cm 2 ) Limit of Power Density (mW/cm 2 ) 1395.5 2.40 1.738 5.91 3.90 0.001348 0.93 Note: the following is Source-based time-averaged maximum output power Calculation Frequency Source-based time-averaged maximum output power Substituted (0dBm) Source-based time- averaged maximum output power (MHz) (dBμV/m) (dBμV/m) (dBm) 1395.5 101.11 95.2 5.91 Reference No.: WTS19S09066153W002 Page 4 of 4 3 Photographs of test setup and EUT. Note: Please refer to appendix AP70 -Photo. ======End of Report======

Waltek Services (Shenzhen) Co.,Ltd. http://www.waltek.com.cn Page 1 of 41 TEST REPORT Re ference No. .................... : WTS19S09066153W001 V1 FCC ID ................................ : ZLZ-WMTSAP70 Applicant ............................ : Shenzhen Mindray BIO-Medical electronics Co.,LTD. Address .............................. : Mindray Building, Keji 12th Road South, Hi-tech Ind, Shenzhen , C hina Manufacturer .................... : The same as above Address .............................. : The same as above Product ............................... : WMTS Access Point Model(s). ............................ : AP70 Brand Name ....................... : Mindray Standards........................... : FCC CFR47 Part 95 Subpart H Date of Receipt sample .... : 2019-09-23 Date of Test ....................... : 2019-09-24 to 2019-11-25 Date of Issue ...................... : 2020-03-17 Test Result ......................... : Pass Remarks: The results shown in this test report refer only to the sample(s) tested, this test report cannot be reproduced, except in full, without prior written permission of the company. The report would be invalid without specific stamp of test institute and the signatures of compiler and approver. Prepared By: Waltek Services (Shenzhen) Co., Ltd. Address: 1/F., Fukangtai Building, West Baima Road, Songgang Street, Baoan District, Shenzhen, Guangdong, China Tel :+86-755-83551033 Fax:+86-755-83552400 Compiled by: Approved by: Ford Wang / Project Engineer Philo Zhong / Manager Reference No.: WTS19S09066153W001 V1 Page 2 of 41 Waltek Services (Shenzhen) Co.,Ltd. http://www.waltek.com.cn 2 Contents Page 1 COVER PAGE ...................................................................................................................................... 1 2 CONTENTS ............................................................................................................................................................ 2 3 REVISION HISTORY ............................................................................................................................................ 3 4 GENERAL INFORMATION .................................................................................................................................. 4 4.1 GENERAL DESCRIPTION OF E.U.T. ............................................................................................................... 4 4.2 DETAILS OF E.U.T. ......................................................................................................................................... 4 4.3 TEST MODE ..................................................................................................................................................... 5 5 TEST SUMMARY .................................................................................................................................................. 6 6 TEST FACILITY ..................................................................................................................................................... 7 7 EQUIPMENT USED DURING TEST .................................................................................................................. 8 7.1 EQUIPMENTS LIST ........................................................................................................................................... 8 7.2 MEASUREMENT UNCERTAINTY ....................................................................................................................... 8 7.3 TEST EQUIPMENT CALIBRATION ..................................................................................................................... 9 8 FIELD STRENGTH OF FUNDAMENTAL ........................................................................................................ 10 8.1 EUT OPERATION ........................................................................................................................................... 10 8.2 TEST PROCEDURE ........................................................................................................................................ 10 8.3 TEST LIMITS ................................................................................................................................................... 10 8.4 TEST RESULT ................................................................................................................................................ 11 9 FIELD STRENGTH OF SPURIOUS EMISSIONS .......................................................................................... 12 9.1 EUT OPERATION ........................................................................................................................................... 12 9.2 TEST SETUP .................................................................................................................................................. 12 9.3 SPECTRUM ANALYZER SETUP ...................................................................................................................... 14 9.4 TEST PROCEDURE ........................................................................................................................................ 15 9.5 SUMMARY OF TEST RESULTS ....................................................................................................................... 16 10 OCCUPIED BANDWIDTH .................................................................................................................................. 18 10.1 EUT OPERATION ...................................................................................................................................... 18 10.2 TEST PROCEDURE .................................................................................................................................... 18 10.3 TEST RESULT .........................................................................................................…

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Appendix-AP70-Photos Page 1 of 15 Photographs –Constructional Details WMTS Setup photo Model AP70 FCC ID: ZLZ-WMTSAP70 Photograph - Spurious Emissions Radiated Test Setup For 30MHz-1000MHz For Above 1GHz