Mindray BIO Medical electronics TD608FE Telemetry Transmitter User Manual 608M FDA

Shenzhen Mindray BIO-Medical electronics Co.,LTD. Telemetry Transmitter 608M FDA

User Manual

BeneVision TMS60 Telemetry Monitoring SystemOperator’s Manual
IntroductionTMS60 Operator’s Manual I© Copyright 2015 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. All rights reserved.For this Operator’s Manual, the issue date is 2015-06.
Intellectual Property Statement IntroductionII TMS60 Operator’s ManualIntellectual Property StatementSHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. (hereinafter called Mindray) owns the intellectual property rights to this Mindray 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 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, 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.Manufacturer’s ResponsibilityContents 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 connection with the furnishing, performance, or use of this manual.Mindray is responsible for the effects on safety, reliability and performance of this product, only if:■all installation operations, expansions, changes, modifications and repairs of thisproduct are conducted by Mindray authorized personnel;■the electrical installation of the relevant room complies with the applicablenational and local requirements;■the product is used in accordance with the instructions for use.
Introduction WarrantyTMS60 Operator’s Manual IIIWarrantyMindray warrants that components within its products will be free from defects in workmanship 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 workmanship 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 distributor, for any product which shall under normal use and service appear to Mindray to have been defective in material or workmanship. Recommended preventative maintenance, 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 affirmation, 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 warranty. 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., Mahwah, 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 equip-ment.•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 Contact IntroductionIV TMS60 Operator’s ManualExemptionsMindray'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 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 andearthquake or other similar elements of nature or acts of God; (ii) riots, war, civildisorders, rebellions, or revolutions in any country; or (iii) any other cause beyondthe reasonable control of Mindray.■Malfunction or damage caused by improper operation or repair by unqualified orunauthorized service people.■Malfunction of the instrument or part whose serial number is not legible.■Others not caused by instrument or part itself.Company ContactManufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.Address: Mindray Building, Keji 12th Road South, Hi-tech industrial park, Nanshan, Shenzhen 518057, P.R.ChinaWebsite: www.mindray.comE-mail Address: service@mindray.comTel: +86 755 81888998Fax: +86 755 26582680Distributor: Mindray DS USA, Inc.Address: 800 MacArthur Boulevard, Mahwah, New Jersey 07430 USATel: 1.800.288.2121, 1.201.995.8000Website: www.mindray.comEC-Representative: Shanghai International Holding Corp. GmbH (Europe)Address: Eiffestraβe 80, 20537 Hamburg, GermanyTel: 0049-40-2513175
Introduction PrefaceTMS60 Operator’s Manual VPrefaceManual PurposeThis manual contains the instructions necessary to operate the product 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 product. If you have any questions, please contact Mindray.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 AudienceThis 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.IllustrationsAll illustrations in this manual serve as examples only. They may not necessarily reflect the setup or data displayed on your patient monitor.Conventions■Italic text is used in this manual to quote the referenced chapters or sections.■[ ] is used to enclose screen texts.■→ is used to indicate operational procedures.Fax: 0049-40-255726
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TMS60 Operator’s Manual 1Contents1 Safety  ........................................................................................................................................ 1 - 11.1 Safety Information  ..................................................................................................................................... 1 - 21.1.1 Warnings  ........................................................................................................................................1 - 31.1.2 Cautions ..........................................................................................................................................1 - 41.1.3 Notes ................................................................................................................................................1 - 51.2 Equipment Symbols  ..................................................................................................................................1 - 52 General Product Description ................................................................................................... 2 - 12.1 Intended Use ................................................................................................................................................2 - 22.2 Applied Parts ................................................................................................................................................2 - 22.3 Key Features  .................................................................................................................................................2 - 22.4 System Components .................................................................................................................................2 - 32.5 TD60 Physical View  .................................................................................................................................... 2 - 32.6 Antenna Array ..............................................................................................................................................2 - 52.7 Telemetry Receiver (RC60)  ...................................................................................................................... 2 - 52.8 Touch Screen Display ................................................................................................................................ 2 - 52.8.1 Display Screen ..............................................................................................................................2 - 62.8.2 On-Screen Keyboard .................................................................................................................. 2 - 73 Getting Started ......................................................................................................................... 3 - 13.1 Unpacking and Checking  ........................................................................................................................3 - 23.2 Environmental Requirements ................................................................................................................ 3 - 33.3 Connecting the ECG Leadwire ...............................................................................................................3 - 43.4 Installing the Batteries ..............................................................................................................................3 - 53.4.1 Installing the Lithium-ion Rechargeable Battery ............................................................. 3 - 63.4.2 Installing the AA Batteries ........................................................................................................3 - 73.5 Powering On the Unit  ...............................................................................................................................3 - 83.6 Understanding Touch Gestures  ............................................................................................................3 - 93.7 Basic Operations .........................................................................................................................................3 - 93.7.1 Understanding the Screen Display Orientation .............................................................3 - 103.7.2 Browsing the Screen Display  ................................................................................................3 - 103.7.3 Switching the Screen Display Orientation .......................................................................3 - 103.7.4 Flipping the Landscape Display ...........................................................................................3 - 103.7.5 Displaying the Quick Keys Area  ...........................................................................................3 - 113.7.6 Entering the Main Menu .........................................................................................................3 - 113.7.7 Turning the Display Off ...........................................................................................................3 - 123.7.8 Turning the Display On ...........................................................................................................3 - 133.7.9 Unlocking the Screen  ..............................................................................................................3 - 13
2 TMS60 Operator’s Manual3.7.10 Acknowledging the Nurse Call ..........................................................................................3 - 133.8 Using the Pouch ........................................................................................................................................3 - 143.8.1 Securing the Pouch ..................................................................................................................3 - 144 User Configurations  ................................................................................................................. 4 - 14.1 Introduction ..................................................................................................................................................4 - 24.2 Configuring the Display  ...........................................................................................................................4 - 24.2.1 Setting the Default Display Orientation  .............................................................................4 - 24.2.2 Understanding Portrait Orientation Display Rules  ......................................................... 4 - 24.2.3 Setting the Portrait Display  .....................................................................................................4 - 24.2.4 Understanding Landscape Orientation Display Rules ...................................................4 - 34.2.5 Setting the Landscape Display ...............................................................................................4 - 44.2.6 Setting the Display Brightness  ...............................................................................................4 - 44.3 Configuring the Audio Volume  ............................................................................................................. 4 - 55 Patient Management  ............................................................................................................... 5 - 15.1 Introduction ..................................................................................................................................................5 - 25.2 Admitting a Patient .................................................................................................................................... 5 - 25.3 Changing the Patient Category ............................................................................................................. 5 - 25.4 Placing a Device in Standby  ...................................................................................................................5 - 35.5 Resume Monitoring ...................................................................................................................................5 - 45.6 Discharging the Patient ............................................................................................................................ 5 - 45.6.1 Selecting the [Discharge Patient] menu .............................................................................5 - 45.6.2 Restarting the TD60  ...................................................................................................................5 - 56 Alarms  ....................................................................................................................................... 6 - 16.1 Introduction ..................................................................................................................................................6 - 26.2 Alarm Categories  ........................................................................................................................................ 6 - 26.3 Alarm Levels  .................................................................................................................................................6 - 26.4 Alarm Indicators ..........................................................................................................................................6 - 36.4.1 Alarm Light .................................................................................................................................... 6 - 36.4.2 Alarm Tones ..................................................................................................................................6 - 36.4.3 Alarm Messages ...........................................................................................................................6 - 46.4.4 Alarm Status Symbols ................................................................................................................ 6 - 46.5 Configuring the Alarms ............................................................................................................................6 - 56.6 Resetting the Alarms ................................................................................................................................. 6 - 57 Monitoring ECG  ........................................................................................................................ 7 - 17.1 Introduction ..................................................................................................................................................7 - 27.2 Safety  ..............................................................................................................................................................7 - 27.3 Preparation for Monitoring ECG  ........................................................................................................... 7 - 37.3.1 Preparing the Patient’s Skin .................................................................................................... 7 - 37.3.2 Positioning the Electrodes .......................................................................................................7 - 3
TMS60 Operator’s Manual 37.3.3 Setting ECG Lead Labeling  ......................................................................................................7 - 57.3.4 Placing the Electrodes ............................................................................................................... 7 - 57.3.5 Checking the Lead Placement ................................................................................................ 7 - 97.3.6 Checking the Paced Status ....................................................................................................7 - 107.4 Changing the ECG Settings ...................................................................................................................7 - 117.4.1 Configuring the ECG Setup  ...................................................................................................7 - 117.4.2 ECG Leadwire Types .................................................................................................................7 - 127.4.3 Configuring the ECG Waveforms  ........................................................................................7 - 127.4.4 Configuring the Pacer  .............................................................................................................7 - 137.4.5 Configuring the ECG Waveform Size  .................................................................................7 - 147.5 Understanding the ECG Display ..........................................................................................................7 - 147.5.1 HR Digital Area ...........................................................................................................................7 - 147.5.2 About the HR Digital Area ......................................................................................................7 - 147.5.3 ECG Waveform Area .................................................................................................................7 - 157.5.4 About the ECG Waveform Area ............................................................................................7 - 158 Monitoring SpO2 (Optional) .................................................................................................... 8 - 18.1 Introduction ..................................................................................................................................................8 - 28.2 Measurement Limitations  .......................................................................................................................8 - 28.3 Safety  ..............................................................................................................................................................8 - 38.4 Connecting the SpO2 Module  ...............................................................................................................8 - 48.5 Changing the SpO2 Settings ..................................................................................................................8 - 58.5.1 Configuring the SpO2 Setup ................................................................................................... 8 - 58.5.2 Configuring the SpO2 Waveform ..........................................................................................8 - 88.6 SpO2 Measurement ................................................................................................................................... 8 - 88.6.1 Identifying SpO2 Modules .......................................................................................................8 - 88.6.2 Applying the Sensor ...................................................................................................................8 - 88.7 Understanding the SpO2 Display .......................................................................................................8 - 108.7.1 SpO2 Digital Area ......................................................................................................................8 - 108.7.2 About the SpO2 Digital Area  ................................................................................................8 - 118.7.3 SpO2 Waveform Area  ..............................................................................................................8 - 118.7.4 About the SpO2 Waveform Area .........................................................................................8 - 118.8 Masimo Information ................................................................................................................................8 - 129 Monitoring with the TD60 at the CS  ....................................................................................... 9 - 19.1 Introduction ..................................................................................................................................................9 - 29.2 Physiological Alarms  ................................................................................................................................. 9 - 29.2.1 Factory Default Parameter Alarm Limits .............................................................................9 - 39.2.2 Parameter Alarm Responses  ................................................................................................... 9 - 49.2.3 Factory Default Parameter Alarm Settings  ........................................................................9 - 59.2.4 Factory Default Arrhythmia Alarm Settings  ......................................................................9 - 69.2.5 Arrhythmia Threshold Settings ............................................................................................9 - 109.3 ECG Monitoring .........................................................................................................................................9 - 129.3.1 HR Settings ..................................................................................................................................9 - 12
4 TMS60 Operator’s Manual9.3.2 Waveform Setup ........................................................................................................................9 - 139.3.3 Other Settings  ............................................................................................................................9 - 159.3.4 ECG Display  .................................................................................................................................9 - 169.4 QT Monitoring  ...........................................................................................................................................9 - 189.4.1 Measurement Limitations ......................................................................................................9 - 189.4.2 QT Settings ..................................................................................................................................9 - 189.4.3 QT View Menu (Only for Mindray ECG Algorithm) ........................................................9 - 209.4.4 QT Display ....................................................................................................................................9 - 219.5 ST Monitoring  ............................................................................................................................................9 - 229.5.1 Measurement Limitations ......................................................................................................9 - 239.5.2 ST Settings ...................................................................................................................................9 - 239.5.3 Adjusting ST Measurement Points  .....................................................................................9 - 249.5.4 ST Display .....................................................................................................................................9 - 259.5.5 ST Segment Display ..................................................................................................................9 - 269.6 Arrhythmia Monitoring  ..........................................................................................................................9 - 279.6.1 Measurement Limitations ......................................................................................................9 - 279.6.2 Understanding the Arrhythmia Events .............................................................................9 - 279.6.3 Arrhythmia Settings .................................................................................................................9 - 309.6.4 Relearning ....................................................................................................................................9 - 309.6.5 Configuring the QRS Threshold ...........................................................................................9 - 319.7 SpO2 Monitoring ......................................................................................................................................9 - 339.7.1 Measurement Limitations ......................................................................................................9 - 339.7.2 SpO2 Settings .............................................................................................................................9 - 339.7.3 SpO2 Display ...............................................................................................................................9 - 3410 Configuring the TD60  .......................................................................................................... 10 - 110.1 Introduction .............................................................................................................................................10 - 210.2 Maintenance Menu  ...............................................................................................................................10 - 210.2.1 Entering the Maintenance menu ......................................................................................10 - 210.2.2 Configuring the General Menu ..........................................................................................10 - 210.2.3 Configuring the Alarms Menu  ...........................................................................................10 - 310.2.4 Quick Keys Menu  ....................................................................................................................10 - 510.2.5 Configuring the Defaults Menu .........................................................................................10 - 610.2.6 Transferring a Configuration  ..............................................................................................10 - 710.2.7 Screen Lock Menu  ..................................................................................................................10 - 810.2.8 Changing the Passwords  .....................................................................................................10 - 910.2.9 Changing the Device Name ................................................................................................10 - 910.2.10 Demo Mode  ...........................................................................................................................10 - 910.2.11 Service Menu  .........................................................................................................................10 - 911 Battery ................................................................................................................................... 11 - 111.1 Introduction .............................................................................................................................................11 - 211.2 Safety ..........................................................................................................................................................11 - 211.3 Installing the Battery .............................................................................................................................11 - 311.4 Checking the Battery Charge Status  ...............................................................................................11 - 4
TMS60 Operator’s Manual 511.5 Removing the Battery ...........................................................................................................................11 - 411.6 Charging the Rechargeable Lithium-ion Battery ........................................................................11 - 511.7 Storing the Batteries  .............................................................................................................................11 - 611.7.1 Storing Rechargeable Lithium-ion Battery ....................................................................11 - 611.7.2 Storing AA Batteries ...............................................................................................................11 - 611.8 Maintaining the Rechargeable Lithium-ion Battery ..................................................................11 - 711.9 Disposing of the Batteries ...................................................................................................................11 - 811.9.1 Disposing of the Rechargeable Lithium-ion Battery  .................................................11 - 811.9.2 Disposing of the AA Batteries  ............................................................................................11 - 812 Troubleshooting ................................................................................................................... 12 - 112.1 General Problems ...................................................................................................................................12 - 212.1.1 Troubleshooting Tools  .........................................................................................................12 - 212.1.2 Problem List ..............................................................................................................................12 - 212.2 Physiological Alarm Messages at the CS  .......................................................................................12 - 312.3 Technical Alarm Messages at the TD60  .........................................................................................12 - 513 Cleaning and Disinfecting  ................................................................................................... 13 - 113.1 Introduction .............................................................................................................................................13 - 213.2 Safety Information .................................................................................................................................13 - 213.3 Cleaning of the TD60 ............................................................................................................................13 - 313.4 Cleaning the Reusable ECG Leadwires, SpO2 Modules and Sensors ..................................13 - 413.5 Cleaning the Battery and Battery Compartment ........................................................................13 - 513.6 Disinfection  ..............................................................................................................................................13 - 513.7 Sterilization  ..............................................................................................................................................13 - 514 Maintenance  ......................................................................................................................... 14 - 114.1 Introduction .............................................................................................................................................14 - 214.2 Safety ..........................................................................................................................................................14 - 214.3 Regular Check ..........................................................................................................................................14 - 314.3.1 Power-on Test ..........................................................................................................................14 - 314.3.2 Battery Check ...........................................................................................................................14 - 314.4 Maintenance and Testing Schedule ................................................................................................14 - 414.5 Checking the System Information ...................................................................................................14 - 414.6 Verifying the ECG at the TD60 ...........................................................................................................14 - 415 Accessories ............................................................................................................................ 15 - 115.1 ECG Accessories ......................................................................................................................................15 - 215.1.1 ECG Electrodes .........................................................................................................................15 - 215.1.2 ECG Leadsets ............................................................................................................................15 - 315.2 SpO2 Accessories  ...................................................................................................................................15 - 315.2.1 Masimo SpO2 Module  ..........................................................................................................15 - 3
6 TMS60 Operator’s Manual15.2.2 Masimo SpO2 Sensor  ............................................................................................................15 - 415.2.3 Nonin SpO2 Module ..............................................................................................................15 - 415.2.4 Nonin SpO2 Sensor ................................................................................................................15 - 415.3 Miscellaneous ..........................................................................................................................................15 - 5A Product Specifications .............................................................................................................A - 1A.1 Classifications ..............................................................................................................................................A - 2A.2 Environmental Specifications ................................................................................................................A - 2A.3 Power Supply Specifications ..................................................................................................................A - 3A.3.1 TD60  ................................................................................................................................................A - 3A.3.2 RC60 .................................................................................................................................................A - 3A.3.3 Central Charger  ...........................................................................................................................A - 4A.4 Physical Specifications  .............................................................................................................................A - 4A.4.1 TD60  ................................................................................................................................................A - 4A.4.2 RC60 .................................................................................................................................................A - 4A.4.3 Central Charger  ...........................................................................................................................A - 4A.5 Hardware Specifications ..........................................................................................................................A - 5A.5.1 TD60  ................................................................................................................................................A - 5A.5.2 RC60 .................................................................................................................................................A - 6A.5.3 Central Charger  ...........................................................................................................................A - 6A.6 Wireless Specification ...............................................................................................................................A - 7A.6.1 Technique Specification ...........................................................................................................A - 7A.6.2 Implemented Functions ...........................................................................................................A - 7A.6.3 Function Specification ..............................................................................................................A - 8A.7 Mindray Patient Area Network (PAN) Specification ......................................................................A - 9A.7.1 Technique Specification ...........................................................................................................A - 9A.7.2 Implemented Function .............................................................................................................A - 9A.7.3 Function Specification ..............................................................................................................A - 9A.8 Measurement Specifications ...............................................................................................................A - 10A.8.1 ECG ................................................................................................................................................ A - 10A.8.2 SpO2 .............................................................................................................................................A - 14B EMC ............................................................................................................................................ B - 1C FCC Compliance ........................................................................................................................ C - 1D Symbols and Abbreviations ....................................................................................................D - 1D.1 Units ............................................................................................................................................................... D - 2D.2 Symbols ........................................................................................................................................................ D - 3D.3 Abbreviations ............................................................................................................................................. D - 3E Anomaly  .....................................................................................................................................E - 1E.1 Anomaly Description ................................................................................................................................. E - 1
TMS60 Operator’s Manual 1 - 11SafetySafety Information...................................................................................................1-2Equipment Symbols................................................................................................1-5
Safety Information Safety1 - 2 TMS60 Operator’s Manual1.1 Safety InformationWARNING•Indicates a potential hazard or unsafe practice that, if not avoided, could result in death or serious injury.CAUTION•Indicates a potential hazard or unsafe practice that, if not avoided, could result in minor personal injury or product/property damage.NOTE•Provides application tips or other useful information to ensure that you get the most from your product.
Safety Safety InformationTMS60 Operator’s Manual 1 - 31.1.1 WarningsWARNING•The TD60 is intended to be used for a single patient at a time.•The Telemetry Monitoring System (TMS60) must be operated by medical personnel in hospitals or medical institutions.•To avoid explosion hazard, do not use the equipment in the presence of oxygen-rich atmospheres, flammable anesthetics, or other flammable agents.•Do not use this equipment in conjunction with Electro Surgical Unit (ESU).•Do not expose the equipment to a Magnetic Resonance (MR) environment.◆Thermal injury and burns may occur due to the metal componentsof the equipment which can heat during MR scanning.◆The equipment may present a risk of projectile injury due to thepresence of ferromagnetic materials which can be attracted by theMR magnet core.◆The leadwires and electrodes will generate artifacts in the MRimage.◆The equipment will not function properly due to the strong mag-netic and radio frequency fields generated by the MR scanner.•Before putting the system into operation, the operator must verify that the equipment, connecting cables and accessories are in correct working order and operating condition. •Do not come into contact with the patient during defibrillation. Otherwise serious injury or death could result. •Do not touch the patient and live parts simultaneously. •Do not open the equipment housings. All servicing and future upgrades must be carried out by trained and authorized personnel.•Do not rely exclusively on the audible alarm system for monitoring. Adjustment of alarm volume to a low level may result in a hazard to the patient. Always keep the patient under close surveillance.•The physiological data and alarm messages displayed on the system are for reference only and cannot be directly used for diagnostic interpretation.
Safety Information Safety1 - 4 TMS60 Operator’s Manual1.1.2 CautionsWARNING•Do not operate the touch screen with water on the hand.•Only use parts and accessories specified in this manual.•Route, wrap and secure the cables to avoid inadvertent disconnection, stumbling and entanglement.CAUTION•Do not let the display directly touch the patient when the display is on.•When the central station presents the alarm “No RF Signal”, the setting being performed on the TD60 may not be transferred to the central station. Check the patient condition and the settings on the central station.•When disposing of the packaging material, be sure to observe the applicable waste control regulations and keep it out of children’s reach. •After the configurations, such as the patient category, paced status, are changed at the TD60, the medical personnel shall be check those configurations at the CS to make sure both of the configurations are consistent.•Magnetic and electrical fields are capable of interfering with the proper performance of the equipment. For this reason make sure that all external equipment operated in the vicinity of the equipment comply with the relevant EMC requirements. Mobile phone, X-ray equipment or MRI equipment are a possible source of interference as they may emit higher levels of electromagnetic radiation. •Always install or carry the equipment properly to avoid damage caused by drop, impact, strong vibration or other mechanical force.•Dry the equipment immediately in case of rain or water spray. •The system generates and uses the Radio Frequency (RF) energy. If it is not installed correctly or not used as per the manual, RF interference to other equipment could result.•Signal quality can be impacted on an ambulatory patient by the construction materials used within the hospital.
Safety Equipment SymbolsTMS60 Operator’s Manual 1 - 51.1.3 Notes1.2 Equipment SymbolsCAUTION•At the end of its service life, the equipment, and its accessories, must be disposed of in compliance with the guidelines regulating the disposal of such products. If you have any questions concerning disposal of the equipment, please contact Mindray.•When programming the frequency for a transmitter,the frequencies allocated to all other transmitters need to be considered to ensure that no two transmitters are programmed with the same frequency.NOTE•Put the equipment in a location where you can easily see the screen, and access the operating controls. •The software was developed in compliance with IEC60601-1-4. The possibility of hazards arising from software errors is minimized.•This manual describes all features and options. Your equipment may not have all of them.•Keep this manual in the vicinity of the equipment so that it can be obtained conveniently when needed.Symbol Description Symbol DescriptionPower On/Off key Main menu keyNurse call key Alternating current (AC)Defibrillation-proof Type CF applied partSerial numberDate of Manufacture Symbol for “MANUFAC-TURER”
Equipment Symbols Safety1 - 6 TMS60 Operator’s ManualMR Unsafe – do not sub-ject to magnetic reso-nance imaging (MRI)Protection against fluid ingressInterference may occur in the vicinity of equip-ment marked with this symbolGeneral warning signRefer to instruction manual/bookletThe presence of this label indicates the machine was certified by ETL with the statement:Conforms to AAMI Std ES 60601-1, IEC 60601-1-6, IEC Std 60601-1-8, IEC Std 60601-2-27, IEC Std 60601-2-49, ISO Std 80601-2-61Certified to CSA Std C22.2 NO. 60601-1, NO. 60601-1-6, NO. 60601-1-8, NO.60601-2-27, NO. 60601-2-49, NO.80601-2-61Symbol Description Symbol DescriptionMRIPX7Intertek3191955ETL CLASSIFIEDNOTE•Some symbols may not appear on your equipment.
TMS60 Operator’s Manual 2 - 12General Product DescriptionIntended Use .............................................................................................................2-2Applied Parts .............................................................................................................2-2Key Features...............................................................................................................2-2System Components ..............................................................................................2-3TD60 Physical View..................................................................................................2-3Antenna Array ...........................................................................................................2-5Telemetry Receiver (RC60)....................................................................................2-5Touch Screen Display..............................................................................................2-5
Intended Use General Product Description2 - 2 TMS60 Operator’s Manual2.1 Intended UseThe TMS60 transmitter is intended for use on Adult and Pediatric patients to monitorECG and SpO2 physiological data. The physiological data can be reviewed locally on thedisplay of the transmitter. The CentralStation will support ECG, Heart Rate, SpO2, PulseRate, Arrhythmia analysis, QT monitoring, and ST Segment Analysis for the TMS60.It must be operated by trained medical personnel in hospitals or medical institutions.2.2 Applied PartsThe equipment has the following applied parts: ■ECG leadwires■SpO2 cables ■SpO2 sensors2.3 Key Features■3.5" color PTC touch screen display is easy for clinicians to use.■Small, portable, and lightweight for patients to wear.■Supports 3/5 lead ECG.■Supports Masimo and Nonin SpO2 modules.■Communication to the CS utilizes the protected WMTS 608-614 band.■Displays the battery status and supports the multiple levels of battery alarms.■Displays Heart Rate (HR) and SpO2 parameters, ECG and SpO2 waveforms.■Battery options of two AA, three AA, or lithium-ion battery pack are available.WARNING•Only skilled/trained clinical professionals should operate this equip-ment.•The equipment is not designed for monitoring critically ill patients.•If the accuracy of any value displayed at the CS or Telemetry transmitter (TD60) is questionable, determine the patient’s vital signs by alternative means and verify that the TMS is working correctly.•The system transmits the data through the wireless connection. There might be a risk of data loss.
General Product Description System ComponentsTMS60 Operator’s Manual 2 - 3■Display supports Parameter auto-sizing.2.4 System ComponentsThe telemetry monitoring system (TMS60) includes the following components:■Telemetry transmitter (TD60)■Telemetry antenna array■Telemetry receiver (RC60)2.5 TD60 Physical View1. Display Activation (Power On/Off) key When the TD60 is powered off◆Pressing this key will turn the TD60 on.When the TD60 is powered on◆If the screen display is on, pressing this key will turn the display off.◆If the screen display is off, pressing this key will turn the display on.◆Press and hold this key for two seconds to display the power off confirma-tion menu.5431268117910
TD60 Physical View General Product Description2 - 4 TMS60 Operator’s Manual2. Nurse Call keyPressing this key will send a nurse call request to the CS. The alarm light/indicator will illuminate cyan, and a “Nurse Call Initiated” message will display in the mes-sage area if the display is on.3. Main Menu key◆Pressing this key when on the main screen will open the main menu.◆Pressing this key when a menu is open will return to the main screen.◆Pressing this key when the display is off will turn the display on.? Pressing this key when the screen lock mode is configured for View Only willdisplay the [Screen Locked] menu.4. DisplayTouch screen display for viewing patient information and adjusting patient set-tings.5. Alarm light/indicatorFlashes in different color and frequency corresponding to the alarm level.6. ECG connectorECG lead connector.7. SpO2 capCovers SpO2 connector when SpO2 is not in use.8. SpO2 connectorConnects the SpO2 module.9. Speaker10. USB connectorIt is only available for authorized service personnel.11. Battery compartmentContains the lithium-ion battery pack or AA battery tray.
General Product Description Antenna ArrayTMS60 Operator’s Manual 2 - 52.6 Antenna ArrayThe antenna array must be installed and configured by Mindray authorized personnel.For more details about the antenna array installation, calibration, and validation, refer tothe Telemetry Monitoring System Installation Guide (P/N 046-007624-00).2.7 Telemetry Receiver (RC60)The RC60 receives the data from the TD60 via the antenna array, and sends the data tothe CS for analysis and display. For details about the general wireless communication problems, refer to "General Prob-lems" on page 12 - 2.For details about the frequency allocation and receiver connection, refer to the Teleme-try Monitoring System Installation Guide (P/N 046-007624-00).For details about the RC60, refer to the TMS60 Service Manual (P/N 046-007057-00).2.8 Touch Screen DisplayMove your finger on the touch screen display to operate the TD60. For details about thesupported touch gestures, refer to "Understanding the Screen Display Orientation" onpage 3 - 10.WARNING•Authorized Mindray personnel are required to confirm the coverage area of the antenna array in the following situations:◆When the antenna array is initially installed.◆When the antenna array is modified.◆When the building construction is modified.WARNING•Do not operate the touch screen with water on the hand.
Touch Screen Display General Product Description2 - 6 TMS60 Operator’s Manual2.8.1 Display ScreenThe main screen displays patient parameters and waveforms. A typical display screen isshown below. 1. Patient information areaThis area shows the patient information such as patient category, device name, and department. Tapping this area displays the [Patient Info] menu.2. Alarm symbols◆ indicates that the alarm system is reset.◆ indicates that the technical alarm audio is turned off.3. Battery symbolThis symbol indicates the battery charge status. Refer to "Checking the Battery Charge Status" on page 11 - 4 for details. Tapping the battery symbol opens the [System Info] menu to the battery section.4. Message areaThis area shows technical alarm messages and informational messages, where there are multiple messages, the messages scroll. 5. Patient data areaThis user configurable area can display parameter/waveform data. The parameter/waveform is labeled in the upper left corner. You may also tap this area to display the Setup menu for the corresponding parameter/waveform. For details about the touch screen operations, refer to "Basic Operations" on page 3 - 9.12345
General Product Description Touch Screen DisplayTMS60 Operator’s Manual 2 - 72.8.2 On-Screen Keyboard The TD60 uses an on-screen keyboard to enter alphanumeric information, such as thedevice name and passwords.2.8.2.1 Alphabetic Keyboard1. Alphabetic buttons: tap to input the desired alphabetic text.2. Delete button: tap to erase the text to the left of the cursor.3. Accept button: tap to save the settings and exit the keyboard.4. Space button: tap to input a space.5. Numeric switch button: tap to switch to the numeric layout.6. Case shift button: tap to switch the case of the letter.This switch is active for one character entry.2.8.2.2 Numeric Keyboard1. Numeric buttons: tap to input the desired numbers.2. Punctuation buttons: tap to input the desired punctuation mark or symbol.3. Delete button: tap to erase the text to the left of the cursor.4. Accept button: tap to save the settings and exit the keyboard.5. Space button: tap to input a space.6. Alphabetic switch button: tap to switch to the alphabetic layout.1234561234567
Touch Screen Display General Product Description2 - 8 TMS60 Operator’s Manual7. More punctuation buttons: tap to display the punctuation keyboard, as shown below.
TMS60 Operator’s Manual 3 - 13Getting StartedUnpacking and Checking......................................................................................3-2Environmental Requirements .............................................................................3-3Connecting the ECG Leadwire ............................................................................3-4Installing the Batteries ...........................................................................................3-5Powering On the Unit.............................................................................................3-8Understanding Touch Gestures..........................................................................3-9Basic Operations.......................................................................................................3-9Using the Pouch .......................................................................................................3-14
Unpacking and Checking Getting Started3 - 2 TMS60 Operator’s Manual3.1 Unpacking and CheckingBefore unpacking, examine the packing case carefully for signs of damage. If any dam-age is detected, contact the carrier or Mindray.If the packing case is intact, open the package and remove the device and accessoriescarefully. Check all materials against the packing list and check for any mechanical dam-age. Contact Mindray in case of any problem.WARNING•The telemetry monitoring system (TMS60) shall be installed by Mindray authorized personnel. •The software equipment copyright is solely owned by Mindray. No orga-nization or individual shall resort to altering, copying, or exchanging it or to any other infringement on it in any form or by any means without due permission.•Connect only approved devices to this system. Devices connected to the equipment must meet the requirements of the applicable IEC standards (e.g. IEC 60950 safety standards for information technology equipment and IEC 60601-1 safety standards for medical electrical equipment). The system configuration must meet the requirements of the IEC 60601-1 medical electrical systems standard. Any personnel who connect devices to the equipment’s signal input/output port is responsible for providing evidence that the safety certification of the devices has been performed in accordance to the IEC 60601-1. If you have any questions, please con-tact Mindray.•If it is not evident from the equipment specifications whether a particu-lar combination with other devices is hazardous, for example, due to summation of leakage currents, please consult the manufacturers or else an expert in the field, to ensure the necessary safety of patients and all devices concerned will not be impaired by the proposed combina-tion.•Contact Mindray to relocate the TMS60.•Only Mindray authorized personnel can update the TMS60.
Getting Started Environmental RequirementsTMS60 Operator’s Manual 3 - 33.2 Environmental RequirementsThe operating environment of the system must meet the requirements specified in thismanual.The equipment operating environment should be reasonably free from noises, vibration,dust, corrosive, flammable and explosive substances.When the device is moved from one place to another, condensation may occur as aresult of temperature or humidity difference. In this case, never start the system beforethe condensation disappears.WARNING•Before use, please verify whether the packages are intact, especially the packages of single use accessories. In case of any damage, do not apply it to patients.•Do not let the display directly touch the patient when the display is on.NOTE•Save the packing case and packaging material as they can be used if the device must be reshipped.WARNING•Make sure that the device operating environment meets the specifica-tions. Otherwise unexpected consequences, e.g. damage to the device, could result.NOTE•The system transmits data through a wireless connection. External radio frequency interference may result in occasionally data dropout. Contact Mindray for any questions regarding the electromagnetic environment.
Connecting the ECG Leadwire Getting Started3 - 4 TMS60 Operator’s Manual3.3 Connecting the ECG Leadwire1. Align the ECG leadwire plug with the ECG connector as indicated by the arrow in the following figure.2. Insert the ECG leadwire plug into the ECG connector as shown in the enlarged fig-ure below.
Getting Started Installing the BatteriesTMS60 Operator’s Manual 3 - 53.4 Installing the BatteriesYou can use two AA, three AA batteries or a lithium-ion rechargeable battery pack to runthe TD60. The runtime is dependent on the battery solution you chose. A lithium-ionbattery pack will provide the longest runtime. For details about the recommended AAbatteries, refer to "Miscellaneous" on page 15 - 5.WARNING•Insert the ECG lead set into the ECG connector. The following perfor-mance may be affected by a weak connection:◆ECG signal quality◆Wireless signal strength◆Water resistance•Do not use the ECG leadwire to move or lift the TD60. This may cause the device to fall, which may damage the equipment or injure the patient.NOTE•ECG leadwires are used as the antenna for the TD60. To ensure good radio performance, always connect the ECG leadwires to the ECG con-nector while monitoring the patient.•Insert the SpO2 cap in the SpO2 connector when SpO2 is not in use.NOTE•Always keep the battery compartment dry.•Never use brute force to install the lithium-ion battery pack or AA bat-tery tray. Otherwise the waterproof ring surrounding the battery frame edge may be broken to affect the waterproof performance.
Installing the Batteries Getting Started3 - 6 TMS60 Operator’s Manual3.4.1 Installing the Lithium-ion Rechargeable Battery1. Make sure the battery compartment is empty.2. Align the hook on the upper part of the lithium-ion battery pack with the slot on the battery compartment, as indicated by the enlarged figure below.WARNING•Only use specified lithium-ion rechargeable batteries. Use of other lith-ium-ion batteries will adversely affect the batteries: ◆Level reporting◆Low battery alarms◆Life performanceNOTE•The lithium-ion rechargeable battery should be fully charged prior to first use.
Getting Started Installing the BatteriesTMS60 Operator’s Manual 3 - 73. Press down the battery pack until it is installed firmly, as indicated by the arrow in the following figure.The TD60 is automatically powered on after the battery is installed.3.4.2 Installing the AA BatteriesThere are two types of AA battery trays, which are used for holding AA batteries:■TP-2AA battery tray can hold two AA batteries.■TP-3AA battery tray can hold three AA batteries.To install the AA batteries:1. Make sure the battery compartment is empty.2. Insert two or three 1.5V alkaline AA batteries according to the diagram in the bot-tom of the battery tray as shown in the images below.Installing two AA batteries Installing three AA batteries
Powering On the Unit Getting Started3 - 8 TMS60 Operator’s Manual3. Align the hook on the upper part of the battery tray with the slot on the battery compartment, as indicated by the enlarged part in the following figure.4. Press down the battery tray until it closes firmly, as indicated by the arrow in the following figure.The TD60 is automatically powered on after the batteries are installed.3.5 Powering On the UnitPress the   key to turn on the TD60. The cyan alarm light will momentarily turn on toindicate that the device is starting. The TD60 performs a self-test during startup. Thedevice sounds a beep, and the alarm light serially turns red, yellow, cyan, and then off.This indicates that the alarm system functions correctly. Upon powering up, there are two situations:■If the TD60 is turned on at first time, the device will request you to configure firsttime startup. Refer to the TMS60 Service Manual (P/N 046-007057-00) for details.■If the TD60 is turned on next time, the device will prompt whether it is a newpatient. Select [Yes] or [No] as desired. If the device is a lock mode, a passcode isrequired.
Getting Started Understanding Touch GesturesTMS60 Operator’s Manual 3 - 93.6 Understanding Touch GesturesBefore using the TD60, understand the supported touch screen gestures: 3.7 Basic OperationsThis section describes the basic operations for the TD60.WARNING•Check that visual and auditory alarm signals are presented correctly when the equipment is powered on. Do not use the equipment for any monitoring procedure on a patient if you suspect the equipment is not working properly or if the equipment is mechanically damaged. Contact your service personnel or Mindray.Gesture DescriptionTap Briefly touch the surface with your fingertip to select a target.Press and hold Touch the surface for extended period of time.Drag Move your fingertip over the surface without losing contact.Swipe Quickly brush the surface with your fingertip.WARNING•Patients should be instructed not to interact with the display of the device and to not open the battery compartment while the TD60 is in use.
Basic Operations Getting Started3 - 10 TMS60 Operator’s Manual3.7.1 Understanding the Screen Display OrientationThe TD60 supports both the portrait and landscape display orientations.■Portrait: both digital and waveform tiles take up the entire width of the screen.■Landscape: the digital tile takes up one half of the width of the screen; thewaveform tile takes up the entire width of the screen.3.7.2 Browsing the Screen DisplayTo scroll through the waveforms/parameters, swipe your finger up or down on thescreen.3.7.3 Switching the Screen Display Orientation1. Swipe your finger down from the top of the main screen to display the drop-down menu.2. Tap the desired option to switch the screen display orientation.For example, to switch from portrait display to landscape display:1. Swipe your finger down from the top of the main screen to display the drop-down menu.2. Tap [Landscape] to switch to landscape display.3.7.4 Flipping the Landscape Display1. Swipe your finger down from the top of the main screen to display the drop-down menu.2. Tap [Flip Display] to horizontally flip the landscape display.Example of portrait display Example of landscape display
Getting Started Basic OperationsTMS60 Operator’s Manual 3 - 113.7.5 Displaying the Quick Keys AreaSwipe your finger up from the bottom of the main screen to display the quick keys area. The following table lists the six default quick keys:You can customize the most frequently used functions to the quick keys. For detailsabout setting the quick keys, refer to "Quick Keys Menu" on page 10 - 5.3.7.6 Entering the Main MenuPress the   key to enter the main menu.The main menu allows access to most of the system functions and settings.Quick keys DescriptionDischarge Patient Tap the button to enter the [Discharge Patient] menu. Refer to "Discharging the Patient" on page 5 - 4 for details.Standby Tap the button to enter the [Standby] menu. Refer to "Placing a Device in Standby" on page 5 - 3 for details.Change Lead Tap the button to change the current first ECG lead waveform to the next ECG lead waveform that is available in sequential order.For example, if the current first ECG lead waveform is I lead, tap the button, the I lead waveform is changed to II lead waveform.Print Tap the button to notify the central station (CS) to start real-time print. The “Print Initiated” message displays on the screen. Manual Event Tap the button to notify the CS to save the event to the event database. The “Manual Event” message displays on the screen. Alarm Reset Tap the button to reset the alarm system. Refer to "Resetting the Alarms" on page 6 - 5 for details.4123
Basic Operations Getting Started3 - 12 TMS60 Operator’s ManualAll menus contain the following parts:1. Heading: displays the current menu title.2. Scroll bar: indicates the current scroll position within the menu.3. Main body: contains menus, buttons, and other controls to configure and operate the device. 4.  exits the current menu and return to the previous menu or the main screen.3.7.7 Turning the Display OffYou can manually turn the display off, or let the display automatically turn off based onthe configured timeout. Press the   key to manually turn the display off.If the touch screen is not touched for the configured Display Auto Off time, then thescreen will turn off after the configured Display Auto Off time.For details about configuring the time for Display Auto Off, refer to "Configuring theGeneral Menu" on page 10 - 2.Controls DescriptionAccesses a submenu to reveal more options or information.Indicates that a password is required for access.Submenus Contains more operations or information related to the corresponding menu.Buttons Provides an option to operate a function.Switch Drag to right to enable the switch; drag to left to disable the switch.NOTE•While the display is off, the TD60 enters the power saving mode, and does not provide audio and visual alarms.
Getting Started Basic OperationsTMS60 Operator’s Manual 3 - 133.7.8 Turning the Display OnIf the screen is off, press the   or   key to turn the display on.3.7.9 Unlocking the ScreenIf you set the screen lock, you need to input the correct passcode to unlock the screenafter the display turns off. To unlock the screen in Locked mode:1. If the screen is off, press the   or   key to turn the display on and access the [Screen Locked] menu.2. Input the passcode to unlock the screen.Once the passcode is entered the screen is temporarily unlocked. If the   is pressed or the device times out, the screen will lock again and a passcode must be entered.To unlock the screen in View Only mode:1. If the screen is off, press the   or   key to turn the display on.2. Press the   key to display the [Screen Locked] menu.3. Input the passcode to unlock the screen.Once the passcode is entered the screen is temporarily unlocked. If the   is pressed or the device times out, the screen will lock again and a passcode must be entered.For details about setting the screen lock, refer to "Screen Lock Menu" on page 10 - 8.3.7.10 Acknowledging the Nurse CallTo acknowledge the triggered nurse call, tap [Attendant Present] in the main menu.The “Nurse Call Cancelled” message will display in the message area.For details about how to trigger a nurse call, refer to "TD60 Physical View" on page 2 - 3.CAUTION•Do not let the display directly touch the patient when the display is on.
Using the Pouch Getting Started3 - 14 TMS60 Operator’s Manual3.8 Using the PouchThe TD60 is not intended for direct contact with the patient’s skin. During normal use,the TD60 could be worn over clothing, in a pocket, or in a pouch. The waterproof pouchwith clear front is an appropriate means for holding the TD60. Both disposable and reus-able pouches specified in this manual can be used for the TD60. For details about thepouch, refer to "Miscellaneous" on page 15 - 5.3.8.1 Securing the PouchTo secure the pouch:1. Place the TD60 into the pouch with the ECG leadwires and the SpO2 sensor cable, if used, exiting from the pouch opening, as shown in the following figures.2. Pinch the snap-fastener to close the pouch.3. Secure the pouch on the patient with ties around the patient’s shoulder and under the arm, as shown in the following figure.WARNING•Do not only rely on the nurse call function, the medical personnel should also pay close attention to the patient’s condition.For disposable pouch For reusable pouch
Getting Started Using the PouchTMS60 Operator’s Manual 3 - 15Wearing the disposable pouch Wearing the reusable pouchWARNING•While using a pouch with the TD60 on the patient, consider the patient’s condition. Be careful about the placement of the straps, as the straps could present a strangulation hazard.NOTE•The pouch is used only for the TD60. The pouch cannot be used for car-rying other personal devices, such as a mobile phone.
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TMS60 Operator’s Manual 4 - 14User ConfigurationsIntroduction...............................................................................................................4-2Configuring the Display.........................................................................................4-2Configuring the Audio Volume...........................................................................4-5
Introduction User Configurations4 - 2 TMS60 Operator’s Manual4.1 IntroductionThis chapter describes the configurations available for users to do, such as configuringthe Display Setup, and Audio Volume.4.2 Configuring the DisplayYou can configure the display by setting the display layout, display orientation, andscreen brightness.In the main menu, tap [Display Setup] to enter the [Display Setup] menu.4.2.1 Setting the Default Display OrientationFor details about the display orientation, refer to "Understanding the Screen DisplayOrientation" on page 3 - 10.1. In the [Setup] section of the [Display Setup] menu, tap [Default Orientation].Two buttons display: [Portrait] and [Landscape].2. Tap a button to set the default orientation.The selected orientation displays to the right of [Default Orientation].3. Restart the TD60 to apply the setting.4.2.2 Understanding Portrait Orientation Display RulesIn portrait orientation, both digital and waveform areas take up the entire width of thescreen. Therefore, these parameters will be displayed in the exact order of the [DisplaySetup] menu, provided the sensor is attached and monitoring data. 4.2.3 Setting the Portrait Display1. In the [Portrait] section of the [Display Setup] menu, tap [Rows].Three options display: [2], [3], and [4]. 2. Tap an option to set the row numbers.The selected option displays to the right of [Rows].3. Tap [Portrait Order] to enter the [Portrait Order] menu.4. Tap a parameter or waveform to select it.The   icon displays to the right of the selected parameter or waveform.5. Drag the selected parameter or waveform to the desired position, and then release it. 6. Repeat steps 4 and 5 until the desired order is configured.7. Tap the   icon to exit the [Portrait Order] menu.
User Configurations Configuring the DisplayTMS60 Operator’s Manual 4 - 34.2.4 Understanding Landscape Orientation Display RulesIn landscape orientation, waveform areas take up the entire width of the screen. Digitalareas only take up one half of the width of the screen. The following rules define how thetiles will be laid out:1. The areas shall be displayed in the order of the [Display Setup] menu except the digital area locations shall be optimized to reduce blank tiles.2. A waveform area always takes up the entire width of the screen.3. A digital area always takes up one half of the width of the screen. Therefore, a row with a digital tile in it shall be split into two half tiles.4. A digital area shall not be the only parameter in a row unless an odd number of digital areas exist. In this case, the last digital parameter area shall have one tile on the left side and the right half will be blank.5. Digital areas shall be paired with the next available digital area to satisfy rule 4. This means that a digital area may be moved ahead of a waveform area if a half of a row needs to be filled.For example, if the landscape display rows is set to [3] and the parameter order is as fol-lows:HRECG IECG IIECG IIIECG aVRECG aVFECG aVLECG VSpO2PLETHThe landscape layout displays as follows:HR* SpO2ECG IECG IIECG IIIECG aVRECG aVFECG aVLECG VPLETH*Bold is displaying on screen; non-bold data need to be scrolled to.
Configuring the Display User Configurations4 - 4 TMS60 Operator’s Manual4.2.5 Setting the Landscape Display1. In the [Landscape] section of the [Display Setup] menu, tap [Rows].Three options display: [2], [3], and [4].2. Tap an option to set the row numbers.The selected option displays to the right of [Rows].3. Tap [Landscape Order] to enter the [Landscape Order] menu.4. Tap a parameter or waveform option to select it.The   icon displays to the right side of the selected parameter or waveform.5. Drag the selected parameter or waveform to the desired position, and then release it.6. Repeat steps 4 and 5 until the desired order is configured.7. Tap the   icon to exit the [Landscape Order] menu.4.2.6 Setting the Display Brightness1. In the [Setup] section of the [Display Setup] menu, tap [Display Brightness].The [Display Brightness] menu displays.2. Drag the slider to left or right to adjust the brightness.3. Tap the   icon to exit the [Display Brightness] menu.
User Configurations Configuring the Audio VolumeTMS60 Operator’s Manual 4 - 54.3 Configuring the Audio VolumeYou can independently set the technical alarm volume, touch screen click, and systolebeep volume. The method for setting the three volumes are the same.To change the volume settings:1. In the main menu, tap [Audio Volume].2. In the [Technical Alarm], [Touch Screen Click], or [Systole Beep] section, drag the slider to the left or right to adjust the volume.3. Tap the   icon to exit the [Audio Volume] menu.NOTE•The   icon indicates that the audio volume is turned off.•The minimum value for the technical alarm volume depends on the min-imum technical alarm volume, refer to "Configuring the Alarms Menu" on page 10 - 3 for details.
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TMS60 Operator’s Manual 5 - 15Patient ManagementIntroduction...............................................................................................................5-2Admitting a Patient.................................................................................................5-2Changing the Patient Category..........................................................................5-2Placing a Device in Standby.................................................................................5-3Resume Monitoring ................................................................................................5-4Discharging the Patient.........................................................................................5-4
Introduction Patient Management5 - 2 TMS60 Operator’s Manual5.1 IntroductionThe chapter describes how to admit a patient, change the patient size, enter and exit theStandby mode, and discharge the patient.5.2 Admitting a PatientWhen admitting a TM80 for the first time, the device must be admitted to the systemthrough the CS. For details about admitting a patient through the CS, refer to the BeneVision Central Station Operator’s Manual (P/N 046-005011-00).After first admitting the device to the CS, you can directly admit the new patient at theTD60 by discharging the current patient, and then pressing the   key to admit a newpatient. Refer to "Discharging the Patient" on page 5 - 4 for details.5.3 Changing the Patient Category1. In the main menu, tap [Patient Info]. 2. In the [Patient Info] menu, tap [Patient Category] to select the desired patient category. The screen displays the “Are you sure you want to change patient category?” mes-sage.3. Select [Yes ] to confirm that the patient category is changed.The selected patient category displays to the right of [Patient Category].4. Tap the   icon to exit the [Patient Info] menu.NOTE•Ensure the patient category selection is appropriate for the patient before monitoring begins.NOTE•The patient category can only be changed at the TD60.•Adjusting patient category restores the TD60 to the default (preset) set-tings but does not clear patient information or data.
Patient Management Placing a Device in StandbyTMS60 Operator’s Manual 5 - 35.4 Placing a Device in StandbyTo enter the Standby mode:1. In the main menu, tap [Standby].2. In the [Standby] confirmation menu, select [Yes ].Placing a device into Standby mode does the following: ■Suspends patient monitoring■Alarms are suspended■Displays [Standby] on the screen.■The screen display automatically turns off after the device enters the Standbymode for 30 seconds.NOTE•When the device is connected to the CS, the patient category at the CS is updated if the patient category is changed at the TD60. Refer to the BeneVision Central Station Operator’s Manual (P/N 046-005011-00) for details.NOTE•When connected to the CS, and a device enters or exits Standby mode, the CS is also notified to enter or exit Standby mode. Refer to the BeneVision Central Station Operator’s Manual (P/N 046-005011-00) for details.NOTE•When connected to the CS, and a device enters or exits Standby mode, the CS is also notified to enter or exit Standby mode.
Resume Monitoring Patient Management5 - 4 TMS60 Operator’s Manual5.5 Resume MonitoringPress the   key to exit Standby mode.Resume monitoring:■Restores patient’s settings, resumes alarm notification on the TD60 and the CS. ■Alarm system is activated.■The TD60 notifies the CS of returning to the Monitoring mode.5.6 Discharging the PatientDischarging the patient will stop monitoring, clear patient information, and restoredefault (preset) settings on the TD60. When a new patient is admitted, the user configu-ration will be applied. If the user configuration has not been saved, the factory defaultconfiguration will be applied.A patient can be discharged by selecting the [Discharge Patient] menu, or restartingthe TD60 and selecting that a new patient is on the TD60.5.6.1 Selecting the [Discharge Patient] menu1. In the main menu, tap [Discharge Patient].2. In the [Discharge Patient] confirmation menu, select [Yes ].◆The patient is discharged from both the TD60 and the CS.◆The patient’s configuration is cleared and the configuration is restored to thesaved user configuration or factory default configuration.◆The patient will be added to the [Discharged Pat.] list at the CS.3. Press the   key to admit a new patient.NOTE•Discharging the patient on the TD60 discharges the patient from the CS. Refer to the BeneVision Central Station Operator’s Manual (P/N 046-005011-00) for details.
Patient Management Discharging the PatientTMS60 Operator’s Manual 5 - 55.6.2 Restarting the TD60 1. If the TD60 is powered off, press the   key to turn on the TD60.The device will prompt as to whether this is a new patient or not.2. Select [Yes ] if this is a new patient. Select [Ye s] when asked to confirm that the dis-charge should begin. Refer to "Selecting the [Discharge Patient] menu" on page 5 - 4 for details on the discharge process.
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TMS60 Operator’s Manual 6 - 16AlarmsIntroduction...............................................................................................................6-2Alarm Categories......................................................................................................6-2Alarm Levels...............................................................................................................6-2Alarm Indicators.......................................................................................................6-3Configuring the Alarms .........................................................................................6-5Resetting the Alarms ..............................................................................................6-5
Introduction Alarms6 - 2 TMS60 Operator’s Manual6.1 IntroductionAlarms, triggered by technical problems, are visually and audibly indicated to the user when the display is on.The TD60 provides a subset of the technical alarms, this chapter describes the technical alarms presented at the TD60 only. For details regarding full list of the technical alarms as well as the physiological alarms displayed at the central station (CS), refer to "Physiological Alarms" on page 9 - 2.6.2 Alarm CategoriesThe TD60 alarm system only supports technical alarms, see the BeneVision Central Station Operator’s Manual (P/N 046-007960-00) for details on physiological alarms.Technical alarms are triggered by system status, patient status, a device malfunction or a patient data distortion due to improper operation or mechanical problems. Technical alarms are available both at the TD60 and the CS.In addition to the technical alarms, the TD60 also displays informational message to inform the user of patient/system status. The TD60 will display informational messages in the message area at the top of the display. 6.3 Alarm LevelsThe alarms can be classified into three severity levels: high level, medium level and low level.WARNING•The reception failure of alarm signals may occur in the distributed alarm system.Alarm Levels Technical alarmsHigh level Indicates a severe device malfunction or an improper operation, which could make it possible that the monitor cannot detect critical patient status and thus threaten the patient’s life, such as low battery.Medium level Indicates a device malfunction or an improper operation, which may not threaten the patient’s life but may compromise the monitoring of vital physi-ological parameters.Low level Indicates a device malfunction or an improper operation, which may compro-mise a certain monitoring function but will not threaten the patient’s life.
Alarms Alarm IndicatorsTMS60 Operator’s Manual 6 - 36.4 Alarm IndicatorsWhen a technical alarm occurs, the TD60 notifies the user through visual or audible alarm indications.■Alarm light■Audible alarm tones■Alarm message6.4.1 Alarm LightIf a technical alarm occurs, the alarm light on the TD60 flashes. The color and flashing frequency correspond to the alarm level as follows:6.4.2 Alarm TonesThe TD60 has three alarm tone configurations: ISO, Mode 1 and Mode 2. For each configuration, the alarm tones enunciate the alarm levels as follows:NOTE•When the TD60 display is off, the user must activate the screen to view any local alarms.■High level alarms:  the lamp quickly flashes red.■Medium level alarms:  the lamp slowly flashes yellow.■Low level alarms: the lamp lights cyan without flashing.■ISO pattern:◆High level alarms:◆Medium level alarms:◆Low level alarms:triple+double+triple+double beeptriple beepsingle beep■Mode 1:◆High level alarms:◆Medium level alarms:◆Low level alarms:high-pitched single beepdouble beeplow-pitched single beep■Mode 2:
Alarm Indicators Alarms6 - 4 TMS60 Operator’s Manual6.4.3 Alarm MessagesWhen a technical alarm occurs on the TD60 screen, the alarm message appears in the message area. The background color of the alarm message and the asterisk symbols (*) before the alarm message are designed to indicate the alarm level.6.4.4 Alarm Status SymbolsThe TD60 still uses the following symbols indicating the alarm status:: indicates the technical alarm audio is turned off.: indicates the alarm system is reset.◆High level alarms:◆Medium level alarms:◆Low level alarms:high-pitched triple beepdouble beeplow-pitched single beepNOTE•When multiple technical alarms of different levels occur simultaneously, the TD60 selects the alarm of the highest level to light the alarm light and sound alarms accordingly, while all the alarm messages scroll in the message area on the top of the screen.Alarms Background color Asterisk symbols (*)High level alarms red ***Medium level alarms yellow **Low level alarms cyan *
Alarms Configuring the AlarmsTMS60 Operator’s Manual 6 - 56.5 Configuring the Alarms■For details on configuring the technical alarm volume, refer to "Configuring theAudio Volume" on page 4 - 5.■For details on configuring the TD60 technical alarm settings, refer to "Configuringthe Alarms Menu" on page 10 - 3.■For the CS alarm configurations, refer to the BeneVision Central Station Opera-tor’s Manual (P/N 046-007960-00).6.6 Resetting the AlarmsYou can acknowledge the on-going alarms by resetting the alarms. After being reset the alarm system can respond to a subsequent alarm condition.When a technical alarm occurs, follow this procedure to reset the TD60 alarm system.■Press the   key to enter the main menu, and then tap [Alarm Reset] from the[Commands] section.OR1. Swipe 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.When the alarm system is reset, depending upon the technical alarm there are several ways the alarm system may respond as follows:■The alarm sound will be silenced, the alarm light will continue to indicate thealarm, a √ will appear before the alarm message. The   symbol appears on thetop of the main screen.■The technical alarm will be changed to the prompt message, it will not longermake sound or be indicated by the alarm light.■The technical alarms are cleared, there will be no alarm indications.For details about the indications of technical alarms when the alarm system is reset, refer to "Technical Alarm Messages at the TD60" on page 12 - 5.
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TMS60 Operator’s Manual 7 - 17Monitoring ECGIntroduction...............................................................................................................7-2Safety............................................................................................................................7-2Preparation for Monitoring ECG .........................................................................7-3Changing the ECG Settings..................................................................................7-11Understanding the ECG Display .........................................................................7-14
Introduction Monitoring ECG7 - 2 TMS60 Operator’s Manual7.1 IntroductionThe chapter describes the ECG monitoring function of the TD60, including skin prepara-tion and lead placement, ECG Setup, ECG Waveform, and Pacer. The TD60 can obtain an ECG value by using a 3/5 lead ECG leadwires in conjunction withthe matching skin electrodes. For details about CS configuration of the ECG parameters, QT analysis, ST analysis, andArrhythmia analysis, refer to Chapter 9 Monitoring with the TD60 at the CS.7.2 SafetyWARNING•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.•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 interference can cause problems with the waveform.NOTE•After defibrillation, the waveform recovers within 10 seconds applied in accordance with the manufacturer’s instructions for use.
Monitoring ECG Preparation for Monitoring ECGTMS60 Operator’s Manual 7 - 37.3 Preparation for Monitoring ECG7.3.1 Preparing the Patient’s SkinProper skin preparation is essential in obtaining an accurate ECG reading. Electrode sitesshould be clean and dry and should provide a smooth flat surface. Incidental electricalactivity and inaccurate readings may arise from incorrect skin preparation.The following procedure is recommended for secure electrode application:1. Shave the chest hair from the electrode sites in a circular area with a diameter of 2 to 4 inches.2. Use a dry gauze pad to remove excess skin oils, skin cells and residue from the electrode sites. Never rub the skin until it is raw or bleeding.7.3.2 Positioning the ElectrodesNOTE•Prepare the electrode site with alcohol only if the skin is extremely greasy. If alcohol is used as a drying agent, always allow the skin to dry before placing the electrode on the skin.NOTE•Store electrodes at room temperature and open just prior to use.•Avoid more than one type of electrode on a patient because of varia-tions in electrical resistance.•Avoid placing electrodes directly over bone prominences or over any high activity movement areas such as shoulders or arms because muscle motion produces electrical activity. If an electrode is placed over a large muscle such as the pectorals, the device may detect this additional mus-cle activity and could lead to false arrhythmia calls.•Using a Transcutaneous Electrical Nerve Stimulator (TENS): Since a TENS unit transmits electrical impulses, avoid placing ECG electrode near the TENS electrodes. ECG electrodes may need to be repositioned and the ECG lead viewed may need to be adjusted until the optimum ECG trac-ing is obtained.
Preparation for Monitoring ECG Monitoring ECG7 - 4 TMS60 Operator’s Manual1. Peel the backing off of the electrode. Visually inspect the contact gel medium for moistness. If the gel medium is not moist, do not use the electrode patch. Dry elec-trode patches are not conductive.2. Attach the electrode patch to the skin at the prepared site. Smooth the electrode patch down in a circular motion to ensure proper skin contact. If using soft gel electrodes, never push down directly over the contact gel medium as this may dis-place the gel and cause monitoring artifact. If using hard gel electrodes, it is rec-ommended that during application, the center of the electrode should be slightly pressed onto the skin to ensure direct contact. Consult the electrode manufac-turer’s instructions for specific use.3. Secure the lead wires to the patient according to hospital practice.NOTE•To prevent evaporation of the contact gel medium, peel the backing off of the electrode patch only when it is ready for use.•If using the snap type lead wires, attach the electrode to the lead wire before placing the electrode on the patient.CAUTION•Route leadwires neatly. Ensure leadwires are kept away from patient’s neck to avoid strangulation. Keep floors and walkways free of cables to reduce risk to hospital personnel, patients and visitors.NOTE•It is recommended that the electrodes be changed at least every 24 to 36 hours to maintain proper contact with the skin, although some patients may require more frequent changing. Do not reapply dispos-able electrode. Try to avoid reusing the exact same electrode site during reapplication. If an electrode becomes wet with fluid, change the elec-trode.
Monitoring ECG Preparation for Monitoring ECGTMS60 Operator’s Manual 7 - 57.3.3 Setting ECG Lead Labeling7.3.3.1 Lead Naming StandardsThis manual presents lead placement according to the guidelines of the American HeartAssociation (AHA) and the International Electro-Technical Commission (IEC).7.3.3.2 Choosing Lead LabelingFor details on choosing the lead labeling, refer to "Configuring the General Menu" onpage 10 - 2. 7.3.4 Placing the ElectrodesFor lead placement, the ECG algorithm works best when the patient’s R wave is signifi-cantly larger than the P wave or the T wave. If the R wave is not significantly larger thanother lower voltage waves on the ECG tracing, the monitor may have some difficulty inidentifying the appropriate waves. On some patients, electrode placement and/or theviewed ECG lead may need to be adjusted in order to obtain a significant R wave. Lead positionAHA IECLabel Color Label ColorChest V Brown C WhiteLeft Leg LL Red F GreenRight Leg RL Green N BlackLeft Arm LA Black L YellowRight Arm RA White R Red
Preparation for Monitoring ECG Monitoring ECG7 - 6 TMS60 Operator’s Manual7.3.4.1 Standard 3-Leadwire Electrode PlacementA 3-wire lead set can monitor one of three ECG vectors (I, II, or III). The recommended 3-wire lead placement is as follows:3-wire lead placement (AHA) 3-wire lead placement (IEC)■Place the RA (white) electrode under the patient’s right clavicle, at the mid-clavicular line within the rib cage frame.■Place the LA (black) electrode under the patient’s left clavicle, at the mid-clavicular line within the rib cage frame.■Place the LL (red) electrode on the patient’s lower left abdomen within the rib cage frame.■Place the R (red) electrode under the patient’s right clavicle, at the mid-clavicular line within the rib cage frame.■Place the L (yellow) electrode under the patient’s left clavicle, at the mid-clavicular line within the rib cage frame.■Place the F (green) electrode on the patient’s lower left abdomen within the rib cage frame.RA LALLRLF
Monitoring ECG Preparation for Monitoring ECGTMS60 Operator’s Manual 7 - 77.3.4.2 Standard 5-Leadwire Electrode PlacementA 5-wire lead set can monitor seven ECG vectors (I, II, III, aVR, aVL, aVF, and V) simultane-ously. The recommended 5-wire lead placement is as follows:5-wire lead placement (AHA) 5-wire lead placement (IEC)■Place the RA (white) electrode under the patient’s right clavicle, at the mid-clavicular line within the rib cage frame.■Place the LA (black) electrode under the patient’s left clavicle, at the mid-clavicular line within the rib cage frame.■Place the LL (red) electrode on the patient’s lower left abdomen within the rib cage frame.■Place the RL (green) electrode on the patient’s lower right abdomen within the rib cage frame.■Place the V (brown) electrode in the V-lead position as shown in the figure or decided by the clinician.■Place the R (red) electrode under the patient’s right clavicle, at the mid-clavicular line within the rib cage frame.■Place the L (yellow) electrode under the patient’s left clavicle, at the mid-clavicular line within the rib cage frame.■Place the F (green) electrode on the patient’s lower left abdomen within the rib cage frame.■Place the N (black) electrode on the patient’s lower right abdomen within the rib cage frame.■Place the C (white) electrode in the C-lead position as shown in the figure or decided by the clinician.
Preparation for Monitoring ECG Monitoring ECG7 - 8 TMS60 Operator’s Manual7.3.4.3 Lead Placement: Pacemaker PatientsThe recommended lead placement for monitoring a pacemaker patient is as follows.A pacemaker patient usually requires a different electrode patch placement configura-tion than a non-pacemaker patient.Do not place an ECG electrode directly over the pacemaker generator. Place the elec-trode patches 3 to 5 inches away from the pacemaker generator area. For example, if thepacemaker generator is located in the right subclavian area, relocate the Right Arm elec-trode closer in towards the center of the chest.3-wire lead placement for a pacemaker patient (AHA)3-wire Lead Placement for a Pacemaker Patient (IEC)5-wire Lead Placement for a Pacemaker Patient (AHA)5-wire Lead Placement for a Pacemaker Patient (IEC)RALALLPacerRLFPacerPacerRAVLALLRLPacerRLCNF
Monitoring ECG Preparation for Monitoring ECGTMS60 Operator’s Manual 7 - 97.3.5 Checking the Lead PlacementWith the Lead Placement function, you can check the lead status, information, and leadoff messages.7.3.5.1 Entering the Lead Placement MenuEnter the [Lead Placement] menu in either of the following ways:■Tap the lead fault message in the message area of the main screen.■In the main menu, tap [Lead Placement].7.3.5.2 Understanding the Lead Placement InstructionsThe [Lead Placement] window indicates the lead status.When any of the leads are off, the indications are as follows:■The lead off message displays on the information bar. The background color of the information bar corresponds to the alarm level.■A flashing circle indicates the disconnected lead.The color of the flashing circle is based on the alarm level.Example lead placement windowInformation barLead off indicator Lead on indicator
Preparation for Monitoring ECG Monitoring ECG7 - 10 TMS60 Operator’s Manual7.3.6 Checking the Paced StatusIt is important to correctly set the patient’s paced status  before you start monitoringECG. To check the paced status:■On the main screen, tap the HR digital area or ECG waveform area to enter the[ECG] menu.OR1. In the main menu, tap [Patient Info].2. In the [Pacer] field, check the setting of the paced status. The current paced status setting displays to the right of [Paced].3. If the paced status setting is not correct, tap [Paced] and select the correct paced status.■When [Paced] is set to [Yes ] at the TD60, and the pacer pulse is detected, the symbol displays in the waveform area of the CS screen, and the pace pulse markswill display on the ECG waveform both at the TD60 and CS.■When [Paced] is set to [No] at the TD60, and the pacer pulse is detected, the symbol displays in the waveform area of the CS screen.WARNING•For paced patients, you must set [Paced] to [Yes]. If it is incorrectly set to [No], the CS could mistake a pace pulse for a QRS and fail to alarm when the ECG signal is too weak. Do not rely entirely on rate meter alarms when monitoring patients with pacemakers. Always keep these patients under close surveillance.•The pacer pulses may be counted as QRS complexes, hence leading to wrong HR readings or failure to diagnose certain arrhythmia symptoms. Be sure to keep a close eye on patient’s with pacemaker devices.•For non-paced patients, you must set [Paced] to [No].•False low heart rate indicators or false asystole calls may result with cer-tain pacemakers because of pacemaker artifact such as electrical over-shoot of the pacemaker overlapping the true QRS complexes.•In order to minimize the possibility of interference, place electrodes, leadwires and TD60s as far away from the pacemaker as possible.
Monitoring ECG Changing the ECG SettingsTMS60 Operator’s Manual 7 - 117.4 Changing the ECG SettingsYou can change the ECG settings from the ECG menu.7.4.1 Configuring the ECG SetupEnter the ECG menu in either of the following ways:■On the main screen, tap the HR digital area or ECG waveform area to enter the[ECG] menu.■In the main menu, tap [Parameter Setup] → [ECG] to enter the [ECG] menu.1. In the [Setup] section of the [ECG] menu, select the options described in the fol-lowing table.NOTE•When [Paced] is set to [Yes], the system does not detect PVC-related arrhythmia (including PVCs) resulting from pacemaker but still analyzes the normal QRS complex.Options  Description Settings*Lead Placement Enters the [Lead Placement] window. Refer to "Checking the Lead Placement" on page 7 - 9 for details.Cable Type Selects the current ECG leadwire type. Auto, 3 Lead, 5 LeadRefer to "ECG Leadwire Types" on page 7 - 12 for details.Smart Lead (Monitored Lead)When [Cable Type] is set to [Auto], the option displays [Smart Lead]. Drag the swtich to right or left to enable or disable the Smart Lead function.When [Cable Type] is set to [3 Lead], the option displays [Monitored Lead].Refer to "ECG Leadwire Types" on page 7 - 12 for details.* The factory default settings are in bold.
Changing the ECG Settings Monitoring ECG7 - 12 TMS60 Operator’s Manual2. Tap   to exit the [ECG] menu.7.4.2 ECG Leadwire TypesECG leadwire type has three options as follows:■[Auto]: the device automatically sets the leadwire type according to the leadsetconnected.■[3 Lead]: the leadwire type is set to 3-lead. If the leadwire type is set to 3-lead, the [Smart Lead] option becomes [Monitored Lead]. You can select the desired lead from the [Monitored Lead] option to set the first ECG waveform displayed on the main screen.■[5 Lead]: the leadwire types is set to 5-lead.All waveform leads display on the main screen.7.4.3 Configuring the ECG Waveforms1. In the [Waveform] section of the [ECG] menu, select the options described in the following table.Filter Selects the ECG filter.MonitorUse under normal measurement conditions.STUse when ST monitoring is applied.Monitor, STColor Selects the ECG waveform color. 16 colorsThe default color is green.Options  Description Settings** The factory default settings are in bold.Options Description Settings*All Lead Size Selects the waveform size for all the leads.To set the waveform size for a specific lead, select that lead from the [Waveform Size] section.1.25 mm/mV, 2.5 mm/mV, 5 mm/mV, 10 mm/mV, 20 mm/mV, 40 mm/mV, AutoThis configuration will be applied for all ECG waveform size.* The factory default settings are in bold.
Monitoring ECG Changing the ECG SettingsTMS60 Operator’s Manual 7 - 132. Tap   to exit the [ECG] menu.7.4.4 Configuring the Pacer1. In the [Pacer] section of the [ECG] menu, tap the options described in the follow-ing table.2. Tap   to exit the [ECG] menu.Speed Selects the waveform sweep speed. 6.25 mm/s, 12.5 mm/s, 25 mm/sOptions Description Settings** The factory default settings are in bold.Options Description Settings*Paced Selects the paced status. Unspecified, No, Yes[Unspecified] is only available for the first time you set the paced sta-tus.Refer to "Checking the Paced Sta-tus" on page 7 - 10 for details.Markers Selects the pacer indicator.LineA 1 cm line shows above each ECG wave-form each time the pace pulse is detected.DotA 2 mm dot shows above each ECG wave-form each time the pace pulse is detected.Line, Dot, OffPacer Reject Selects whether or not to reject the pace pulses.On, Off* The factory default settings are in bold.NOTE•When [Paced] is set to [Yes], the [Markers] and [Pacer Rejection] options can be available.
Understanding the ECG Display Monitoring ECG7 - 14 TMS60 Operator’s Manual7.4.5 Configuring the ECG Waveform SizeThe [Waveform Size] section of the [ECG] menu lists all available leads. You can selectthe desired ECG lead to set the waveform size. 7.5 Understanding the ECG Display7.5.1 HR Digital AreaThe HR digital area displays:1. Parameter name2. Measurement unit3. Heart rate value7.5.2 About the HR Digital Area■The HR area displays heart rate in the unit of bpm with a resolution of 1 bpm.■If the HR measurement is invalid, “- - -” displays in place of the HR value.■The HR value displays “0”, when the HR value is less than 15 bpm.  123
Monitoring ECG Understanding the ECG DisplayTMS60 Operator’s Manual 7 - 157.5.3 ECG Waveform AreaThe ECG waveform area displays:1. ECG Lead2. ECG scale bar3. ECG waveform4. ECG filter setting5. ECG scale7.5.4 About the ECG Waveform Area■The ECG waveform, scale indicator, lead, and filter settings display in theconfigured ECG color.■The ECG waveform area provides scrolling, real-time waveform data and an erasebar to provide a time indicator of oldest and new data.■The ECG waveform area scrolls the waveform in the configured sweep speed.■The ECG waveform area rails the top most value when the waveform exceeds theupper scale limit for real-time waveforms.■The ECG waveform area rails the bottom most value when the waveform exceedsthe lower scale limit for real-time waveforms.■The ECG waveform area indicates a Pacer indicator when a pace pulse is detectedand Paced is enabled.13452
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TMS60 Operator’s Manual 8 - 18Monitoring SpO2 (Optional)Introduction...............................................................................................................8-2Measurement Limitations.....................................................................................8-2Safety............................................................................................................................8-3Connecting the SpO2 Module ............................................................................8-4Changing the SpO2 Settings ...............................................................................8-5SpO2 Measurement................................................................................................8-8Understanding the SpO2 Display ......................................................................8-10
Introduction Monitoring SpO2 (Optional)8 - 2 TMS60 Operator’s Manual8.1 IntroductionThe chapter describes the SpO2 monitoring function at the TD60 in detail, including connecting the SpO2 module, configuring the SpO2, and monitoring the SpO2. For details about the SpO2 parameter setup at the central station (CS), refer to Chapter 9 Monitoring with the TD60 at the CS.SpO2 monitoring is a non-invasive technique used to measure the amount of oxygenated hemoglobin and pulse rate by measuring the absorption of selected wavelengths of light. The light generated in the probe passes through the tissue and is converted into electrical signals by the photo detector in the probe. The SpO2 module processes the electrical signal and displays a waveform and digital values for SpO2 and pulse rate.The TD60 can be configured with Masimo SpO2 or Nonin SpO2.8.2 Measurement LimitationsIf the SpO2 measurement seems out of range or inaccurate, check the patient’s vital signs. Then check the equipment and SpO2 sensor. The following factors may influence the accuracy of measurement:■Ambient light■Physical movement■Low perfusion■Electromagnetic interferenceNOTE•A functional tester or SpO2 simulator cannot be used to assess the accuracy of a SpO2 module or a SpO2 sensor.•This device is calibrated to display functional oxygen saturation.•A pulse oximeter should not be used as an apnea monitor.•Pulse rate measurement is based on the optical detection of a peripheral flow pulse and therefore may not detect certain arrhythmias. The pulse oximeter should not be used as a replacement or substitute for ECG based arrhythmia analysis.•The MS board pulse oximeter can be used during defibrillation, but the readings may be inaccurate for a short time.
Monitoring SpO2 (Optional) SafetyTMS60 Operator’s Manual 8 - 3■Dysfunctional hemoglobin, such as carboxyhemoglobin (COHb) and methemoglobin (MetHb)■Presence of certain dyes, such as methylene and indigo carmine■Inappropriate positioning of the SpO2 sensor, or use of incorrect SpO2 sensor■Drop of arterial blood flow to immeaurable level caused by shock, anemia, low temperature or vasoconstrictor.■Inaccurate measurements may be caused by venous pulsations.■Placement of a sensor on an extremity that has a blood pressure cuff, arterial catheter, or intra-vascular line.■Loss of pulse signal can occur when the sensor is too tight.■Loss of pulse signal can occur when there is arterial occlusion proximal to the sensor.8.3 SafetyWARNING•Only use SpO2 sensors specified in this manual. Follow the SpO2 sensor’s instructions for use and adhere to all warnings and cautions.•The operator is responsible for checking the compatibility of the pulse oximetry monitor, sensor, and patient cable prior to use. Incompatible components can result in degraded performance and/or device malfunction.•When a trend toward patient deoxygenation is indicated, blood samples should be analyzed by a laboratory co-oximeter to completely understand the patient’s condition. •Do not use SpO2 sensors during magnetic resonance imaging (MRI). Induced current could potentially cause burns. The sensor may affect the MRI image, and the MRI unit may affect the accuracy of the oximetry measurements.•Prolonged and continuous monitoring may increase the temperature of the sensor and cause the patient discomfort. It is especially important to check the sensor placement, and ensure proper attachment on patients suffering from poor perfusion or skin sensitivity. Check the sensor location every two to three hours and move to another location if the skin deteriorates. More frequent examinations may be required for different patients.
Connecting the SpO2 Module Monitoring SpO2 (Optional)8 - 4 TMS60 Operator’s Manual8.4 Connecting the SpO2 ModuleConnect the SpO2 module to the TD60. The TD60 can auto detect the SpO2 module type when the SpO2 module is connected.Connecting the Masimo SpO2 moduleSpO2 moduleSpO2 sensorSpO2 sensor con-
Monitoring SpO2 (Optional) Changing the SpO2 SettingsTMS60 Operator’s Manual 8 - 5Connecting the Nonin SpO2 module8.5 Changing the SpO2 SettingsYou can change the SpO2 settings from the SpO2 menu.8.5.1 Configuring the SpO2 SetupEnter the SPO2 menu in either of the following ways:■On the main screen, tap the SpO2 digital area or SpO2 waveform area to enter the [SpO2] menu.■In the main menu, tap [Parameter Setup] → [SpO2] to enter the [SpO2] menu.1. In the [Setup] section of the [SpO2] menu, select the options described in the fol-lowing table.SpO2 moduleSpO2 sensorSpO2 sensor connector
Changing the SpO2 Settings Monitoring SpO2 (Optional)8 - 6 TMS60 Operator’s ManualOptions  Description Settings*Display PI (Masimo only)Configures whether or not to show the perfusion index (PI) value in the digital area.The perfusion index allows clinicians to assess the pulse strength at the monitoring site for optimal sensor placement.PI gives the numerical value for the pulsatile to non-pulsatile portion of the measured signal caused by arterial pulsation. PI is an indicator of the pulsatile strength.On, OffSensitivity(Masimo only)Selects the sensitivity mode depending upon signal quality and patient motion.High:This mode should be used for the sickest patients, where obtaining a reading is most difficult. High Sensitivity is designed to interpret and display data for even the weakest of signals. This mode is recommended during procedures and when clinician and patient contact is continuous.Normal:This mode provides the best combination of sensitivity and probe off detection performance. This mode is recommended for the majority of patients.APOD (Adaptive Probe Off Detection):This mode is the least sensitive in picking up a reading on patients with low perfusion but has the best detection for probe-off conditions. This mode is useful for patients that are at particular risk of the sensor becoming detached (pediatric, combative, etc.)High, Normal, and APOD* The factory default settings are in bold.
Monitoring SpO2 (Optional) Changing the SpO2 SettingsTMS60 Operator’s Manual 8 - 72. Tap   to exit the [SpO2] menu.Averaging(Masimo only)The user-selectable averaging feature allows the clinician to select the desired level of visibility to subtle variations in the measured value. Depending on the patient acuity and area of care, shorter averaging times are sometimes preferred (sleep testing) over longer averaging times (telemetry) and vice-versa.8-second averaging is generally considered the most common averaging interval and recommended for most patients since it is short enough to provide visibility to subtle desaturations while also being long enough to minimize major changes in SpO2 due to quick, transitory desaturations. Although averaging times greater than 10 seconds are more likely to reduce visibility to rapid, brief desaturations, this may be desirable in care areas where brief desaturations that do not require clinician intervention occur more often (such as NICU). It is also recommended that this be enabled as a “sticky” configuration so as to hold the setting after power cycles.2-4 sec, 4-6 sec, 8 sec, 10 sec, 12 sec, 14 sec, 16 secFast SAT(Masimo only)Selects whether or not to enable FastSat. FastSat enables rapid tracking of arterial oxygen saturation changes as may be required in urgent situations.On, OffColor Selects the SpO2 waveform color. 16 colorsThe default color is cyan.Options  Description Settings** The factory default settings are in bold.
SpO2 Measurement Monitoring SpO2 (Optional)8 - 8 TMS60 Operator’s Manual8.5.2 Configuring the SpO2 Waveform1. In the [Waveform] field of the [SpO2] menu, select the options described in the following table.2. Tap   to exit the [SpO2] menu.8.6 SpO2 Measurement8.6.1 Identifying SpO2 ModulesTo identify which SpO2 module you are using, see the company logo on the SpO2 module.■Masimo SpO2 module: white, with a logo of Masimo SET.■Nonin SpO2 module: blue, with a logo of Nonin.8.6.2 Applying the Sensor1. Select an appropriate sensor according to the module type, patient size, and weight.2. Remove colored nail polish from the application site.3. Apply the sensor to the patient.4. Connect the sensor to the SpO2 module and the SpO2 module to the TD60.The SpO2 measurement displays when the TD60 detects that a sensor is con-nected to the patient.Options  Description Settings*Speed Selects the SpO2 pleth waveform speed. 6.25 mm/s, 12.5 mm/s, 25 mm/sDisplay SIQ(Masimo only)Selects whether or nor to show the Signal Indicator Quality (SIQ) in the SpO2 waveform area. The SIQ wave indicates the confidence associated with the saturation measurement and timing of the pulse. Higher pulse indicates a better signal.On, Off* The factory default settings are in bold.
Monitoring SpO2 (Optional) SpO2 MeasurementTMS60 Operator’s Manual 8 - 9WARNING•When equipped with Masimo SpO2 module, use only Masimo SpO2 sensors specified in this manual. Use of other SpO2 sensors may cause improper oximeter performance.•When equipped with Nonin SpO2 module, use only Nonin SpO2 sensors specified in this manual. Use of other SpO2 sensors may cause improper oximeter performance.•Do not disconnect the Nonin Spo2 sensor connector from the Nonin SpO2 module during defibrillation.•If the sensor is too tight because the application site is too large or becomes too large due to edema, excessive pressure for prolonged periods may result in venous congestion distal from the application site, leading to interstitial edema and tissue ischemia.CAUTION•Many patients suffer from poor peripheral perfusion due to hypothermia, hypovolemia, severe vasoconstriction, reduced cardiac output, etc. These symptoms may cause a loss in vital sign readings.
Understanding the SpO2 Display Monitoring SpO2 (Optional)8 - 10 TMS60 Operator’s Manual8.7 Understanding the SpO2 Display8.7.1 SpO2 Digital AreaThe SpO2 digital area displays:1. Parameter name2. SpO2 value3. Perfusion indicator4. Perfusion index (PI) label5. Perfusion index value6. SpO2 unit of measure7. Pulse rate (PR) label8. PR measurement unit9. PR valueMasimo SpO2 digital area (for portrait display)Masimo SpO2 digital area (for landscape display)Nonin SpO2 digital area123678954
Monitoring SpO2 (Optional) Understanding the SpO2 DisplayTMS60 Operator’s Manual 8 - 118.7.2 About the SpO2 Digital Area■The SpO2 digital area displays in units of % with a resolution of 1%.■The SpO2 PR value displays in units of bpm with a resolution of 1 bpm.■Displays Masimo PI resolution as 0.01 when the PI value is smaller than 10%.■Displays Masimo PI resolution as 0.1 when the PI value is greater than or equal to 10%.■If the SpO2 measurement or PR is invalid, “- - -” displays in place of digits.8.7.3 SpO2 Waveform AreaThe SpO2 waveform area displays:1. Signal Indicator Quality (SIQ)2. Area name3. Pleth waveformMasimo SpO2 waveform area (SIQ enabled)Nonin SpO2 waveform area8.7.4 About the SpO2 Waveform Area■Displays in the configured SpO2 color.■Provides scrolling, real-time waveform data.■Scrolls the waveform in the configured sweep speed.■Automatically scales the SpO2 waveform data area to maximize the vertical height of the Pleth waveform for the data range.■If using Masimo SpO2, the Signal Quality Index (SIQ) will display below the waveform if enabled.321
Masimo Information Monitoring SpO2 (Optional)8 - 12 TMS60 Operator’s Manual8.8 Masimo Information■Masimo PatentsThis device is covered under one or more the following U.S.A. patents: 5,758,644; 5,823,950; 6,011,986; 6157,850; 6,263,222; 6,501,975; 7,469,157 and other applica-ble patents listed at: www.masimo.com/patents.htm.■No Implied LicensePossession or purchase of this device does not convey any express or implied license to use the device with unauthorized sensors or cables which would, alone, or in combination with this device, fall within the scope of one or more of the pat-ents relating to this device.
TMS60 Operator’s Manual 9 - 19Monitoring with the TD60 at the CSIntroduction...............................................................................................................9-2Physiological Alarms...............................................................................................9-2ECG Monitoring ........................................................................................................9-12QT Monitoring...........................................................................................................9-18ST Monitoring............................................................................................................9-22Arrhythmia Monitoring..........................................................................................9-27SpO2 Monitoring .....................................................................................................9-33
Introduction Monitoring with the TD60 at the CS9 - 2 TMS60 Operator’s Manual9.1 IntroductionThe chapter describes the configurations and displays at the central station (CS) oncethe TD60 is connected to the CS.At the CS, Mindray ECG algorithm and Mortara ECG algorithm are available. You canselect either algorithm as required.9.2 Physiological AlarmsAt the CS, you can view and change the physiological alarm limits and alarm levels in the[Alarm Setup] menu. The [Alarm Setup] menu has three tabs: ■[Parameter Alarm Settings]: view and change the parameter alarm limits, alarmlevels and alarm responses.■[Arrhythmia Alarms]: view and change the arrhythmia alarms levels, and alarmresponses. ■[Arrh. Threshold Setup]: view and change the arrhythmia threshold settings forsome arrhythmia alarms.For details about the [Alarm Setup] menu, refer to the BeneVision Central StationOperator’s Manual (P/N 046-005011-00).WARNING•Be aware that the devices in your care area may each have different alarm settings to suit different patients. Always check that the alarm set-tings are appropriate for your patient before you start monitoring.•A potential hazard can exist if different alarm presets are used for the same or similar equipment in any single area, such as an intensive care unit or cardiac operating room.•Make sure that the alarm limits settings are appropriate for your patient before monitoring.•When monitoring patients that are not continuously attended by a clini-cal operator, properly configure the alarm system and adjust alarm set-tings as per the patient's condition.•Setting alarm limits to extreme values may cause the alarm system to become ineffective. For example, high oxygen levels may predispose a premature infant to retrolental fibroplasia. If this is a consideration do NOT set the high alarm limit to 100%, which is equivalent to switching the alarm off.
Monitoring with the TD60 at the CS Physiological AlarmsTMS60 Operator’s Manual 9 - 39.2.1 Factory Default Parameter Alarm LimitsThe following table lists the factory default alarm limits for all parameters.WARNING•If you switch off all arrhythmia alarms, the CS cannot give any arrhyth-mia alarms. Always keep the patient under close surveillance.Parameters Alarm limit Adult PediatricHRUnit of measure: bpmInvalid data: “--”High limit (Low limit + 2) to 300Default: 120(Low limit + 2) to 350Default: 160Low limit 15 to (high limit - 2)Default: 5015 to (high limit - 2)Default: 75ST SingleUnit of measure: mVInvalid data: “--”High limit (Low limit + 0.2) to 2.00Default: 0.2(Low limit + 0.2) to 2.00Default: 0.2Low limit -2.00 to (high limit – 0.2)Default: -0.2-2.00 to (high limit – 0.2)Default: -0.2ST DualUnit of measure: mVInvalid data: “--”High limit (Low limit + 0.2) to 2.00Default: 0.2(Low limit + 0.2) to 2.00Default: 0.2Low limit -2.00 to (high limit – 0.2)Default: -0.2-2.00 to (high limit – 0.2)Default: -0.2QTcUnit of measure: msInvalid data: “--”High limit 200 to 800Default: 500200 to 800Default: 480Low limit N/A N/A∆QTc*Unit of measure: msInvalid data: “--”High limit 30 to 200Default: 6030 to 200Default: 60Low limit N/A N/ASpO2Unit of measure: %Invalid data: “--”High limit (Low limit + 1) to 100Default: 100(Low limit + 1) to 100Default: 100Low limit 0 to (high limit - 1)Default: 900 to (high limit - 1)Default: 90* ΔQTc is only available for Mindray ECG algorithm.
Physiological Alarms Monitoring with the TD60 at the CS9 - 4 TMS60 Operator’s Manual9.2.2 Parameter Alarm ResponsesAt the CS, the following parameter alarm responses may occur when a parameter alarmoccurs.■Record on Alarm: directs the CS to send the alarm data to the configured recorder.■Print on Alarm: directs the CS to send the alarm data to the configured printer.■Paging Switch: directs the CS to send an alarm to the beeper to notify the clinician.SpO2 DesatUnit of measure: %Invalid data: “--”High limit N/A N/ALow limit 0 to 100Default: 800 to 100Default: 80PRUnit of measure: bpmInvalid data: “--”High limit (Low limit + 2) to 300Default: 120(Low limit + 2) to 300Default: 160Low limit 18 to (high limit - 2)Default: 5018 to (high limit - 2)Default: 75Parameters Alarm limit Adult Pediatric* ΔQTc is only available for Mindray ECG algorithm.NOTE•The SpO2 Desat alarm limit is restricted such that the alarm limit can not be higher than the SpO2 low limit.
Monitoring with the TD60 at the CS Physiological AlarmsTMS60 Operator’s Manual 9 - 59.2.3 Factory Default Parameter Alarm SettingsThe following table lists the factory default alarm levels and responses for all parameters. ParametersAlarm levels*Activation StateFactory default alarm responsesHigh Medium Low Record on AlarmPrint on AlarmPaging SwitchHR X X** — On Off Off OffST Single X XX Off Off Off OffST Dual X XX Off Off Off OffQTc X XX Off Off Off Off∆QTc*** X XX Off Off Off OffSpO2XX— On Off Off OffSpO2 Desat****X——On Off Off OffPR X X— On Off Off Off* X indicates available alarm level, — indicates alarm level not available** The factory default settings are in bold.*** ΔQTc is only available for Mindray ECG algorithm.**** The alarm level option for SpO2 Desat is not configurable. [High] is the only alarm level and cannot bechanged.
Physiological Alarms Monitoring with the TD60 at the CS9 - 6 TMS60 Operator’s Manual9.2.4 Factory Default Arrhythmia Alarm Settings9.2.4.1 Mindray AlgorithmParametersAlarm levels*Activation StateFactory default alarm responsesHigh Medium Low MessageRecord on AlarmPrint on AlarmPaging SwitchAsystole X** — — — On Off Off OffVFib/VTac X— — — On Off Off OffVTac X— — — On Off Off OffVent. Brady X— — — On Off Off OffExtreme Tachy X— — — On Off Off OffExtreme Brady X— — — On Off Off OffPVCs/min X XX X On Off Off OffR on T X XX X On Off Off OffRun PVCs X X XX Off Off Off OffCouplet X X X XOff Off Off OffPVC X X X XOff Off Off OffVent. RhythmXXX X On Off Off OffBigeminy X XX X On Off Off OffTrigeminy X XX X On Off Off OffTachy X XX X Off Off Off OffBrady X XX X Off Off Off OffPacer Not PacingXX XXOff Off Off Off* X indicates available alarm level, — indicates alarm level not available** The factory default settings are in bold.
Monitoring with the TD60 at the CS Physiological AlarmsTMS60 Operator’s Manual 9 - 7Pacer Not CaptureXX XXOff Off Off OffMissed Beat X X X XOff Off Off OffMultif. PVC X XX X Off Off Off OffNonsus. VtacXXX X On Off Off OffPause X X XX Off Off Off OffAFib X X X XOff Off Off OffIrr.Rhythm — — X XOff Off Off OffPauses/min X XX X On Off Off OffParametersAlarm levels*Activation StateFactory default alarm responsesHigh Medium Low MessageRecord on AlarmPrint on AlarmPaging Switch* X indicates available alarm level, — indicates alarm level not available** The factory default settings are in bold.NOTE•When [Paced] is set to [Yes], the Missed Beat (MIS) alarm is reported as the pacer not captured (PNC) or pacer not paced (PNP) alarm.
Physiological Alarms Monitoring with the TD60 at the CS9 - 8 TMS60 Operator’s Manual9.2.4.2 For Mortara AlgorithmParametersAlarm levels*Activation StateFactory default alarm responsesHigh Medium Low MessageRecord on AlarmPrint on AlarmPaging SwitchAsystole X** — — — On Off Off OffVFib X— — — On Off Off OffVTac X— — — On Off Off OffExtreme Tachy X— — — On Off Off OffExtreme Brady X— — — On Off Off OffPVCs/min X XX X On Off Off OffR on T X XX X On Off Off OffRun PVCs X X XX Off Off Off OffCouplet X X X XOff Off Off OffVent. RhythmXXX X On Off Off OffBigeminy X XX X On Off Off OffTrigeminy X XX X On Off Off OffTachy X XX X Off Off Off OffBrady X XX X Off Off Off OffPacer Not PacingXX XXOff Off Off OffPacer Not CaptureXX XXOff Off Off OffMultif. PVC X XX X Off Off Off OffPause X X XX Off Off Off Off* X indicates available alarm level, — indicates alarm level not available** The factory default settings are in bold.
Monitoring with the TD60 at the CS Physiological AlarmsTMS60 Operator’s Manual 9 - 9In addition, the activation state of some arrhythmias can be set as a whole with the fol-lowing buttons that are at the bottom of the [Arrhythmia Alarms] tab.Irr.Rhythm — — X XOff Off Off OffPauses/min X XX X On Off Off OffParametersAlarm levels*Activation StateFactory default alarm responsesHigh Medium Low MessageRecord on AlarmPrint on AlarmPaging Switch* X indicates available alarm level, — indicates alarm level not available** The factory default settings are in bold.NOTE•The priority of lethal arrhythmia alarms is always high. It is unchange-able.Button DescriptionLethals Only Sets the lethal arrhythmia alarms to on and all non-lethal arrhythmia alarms to off.All Alarm On Sets all arrhythmia alarms to on.All Alarm Off Sets all arrhythmia alarms to off.This button is enabled when the [Lethal Arrh. OFF] option in the [Telemetr y] tab from the [Admin Setup] menu is set to [Enable].
Physiological Alarms Monitoring with the TD60 at the CS9 - 10 TMS60 Operator’s Manual9.2.5 Arrhythmia Threshold SettingsWhen an arrhythmia violates its threshold, an alarm is triggered. For the Mortara algo-rithm, the setting of asystole delay is related to arrhythmia relearn. When HR is less than30 bpm, it is recommended to set asystole delay to 10 s.9.2.5.1 Mindray ECG algorithmArrh. event Range or Option Default Step Unit of measurePVCs High 1 to 100 10 1 minutePauses/min 1 to 15 8 1 N/AAsys. Delay 3 to 10 4 1 secondTachy High 60 to 300 Adult: 120Pediatric: 1605bpmBrady Low 15 to 120 Adult: 50Pediatric: 755bpmExtreme Tachy 60 to 300 Adult: 160Pediatric: 1805bpmExtreme Brady 15 to 120 Adult: 35Pediatric: 505bpmMultif. PVC’s Window 3 to 31 15 1 /minVtac Rate 100 to 200 130 5 bpmVtac PVC 3 to 99 6 1 beatPause Time 1.5, 2.0, and 2.5  2.0 N/A secondVbrd Rate 15 to 60 40 5 bpmVbrd PVCs 3 to 99 5 1 beat
Monitoring with the TD60 at the CS Physiological AlarmsTMS60 Operator’s Manual 9 - 119.2.5.2 Mortara ECG algorithmArrh. event Range or Option Default Step UnitPVCs High 1 to 100 10 1 minutePauses/min 1 to 15 8 1 N/AAsys. Delay 2 to 10 4 1 secondsVtac Rate 100 to 200 130 5 bpmVtac PVC 3 to 12 6 1 beatExtreme Tachy Adult: 100 to 300Pediatric: 160 to 300Adult: 160Pediatric: 1805bpmExtreme Brady Adult: 15 to 60Pediatric: 15 to 80Adult: 35Pediatric: 505bpmMultif. PVC’s Window 3 to 31 15 1 /minTachy High Adult: 100 to 300Pediatric: 160 to 300Adult: 120Pediatric: 1605bpmBrady Low Adult: 15 to 60Pediatric: 15 to 80Adult: 50Pediatric: 755bpmPause Threshold RR 1.2, 1.3, 1.4, 1.5, 1.6, 1.7, 1.8, 1.9, and 2.02.0 N/A s
ECG Monitoring Monitoring with the TD60 at the CS9 - 12 TMS60 Operator’s Manual9.3 ECG Monitoring At the CS, you can view and change the heart rate (HR), QT, ST, and arrhythmia settings inthe [ECG] tab of the [Parameter Setup] menu.For details about the [Parameter Setup] menu, refer to the BeneVision Central StationOperator’s Manual (P/N 046-005011-00).9.3.1 HR SettingsThe following table lists the HR settings in the [HR] section of the [ECG] tab.Options or Buttons Description Settings*HR Activation State Configures whether or not to enable the HR alarm.On, OffHR Alarm Priority Configures the HR alarm levels. High, MedHR High Limit (bpm) Configures the HR high alarm limit. Adult:(Low limit + 2) to 300The default is 120.Pediatric:(Low limit + 2) to 350The default is 160.HR Low Limit (bpm) Configures the HR low alarm limit. Adult:15 to (high limit - 2)The default is 50.Pediatric:15 to (high limit - 2)The default is 75.Pacer Rate (bpm) (only Mortara ECG algorithm)When some pacemaker pulses are difficult to reject, the pulses are counted as a QRS complex and could result in an incorrect HR and failure to detect some arrhythmias. Configures the pacemaker rate, the sys-tem can calculate HR and detect arrhyth-mias more accurately.40 to 100The default is 60.The option is unavailable when [Paced] is set to [No] at the TD60. For details about the paced status, refer to "Checking the Paced Status" on page 7 - 10.Sweep Speed Configures the ECG wave speed. 6.25 mm/s, 12.5 mm/s, 25 mm/s, 50 mm/sHR Source Configures the HR source. ECG, SpO2, Auto, Both* The factory default settings are in bold.
Monitoring with the TD60 at the CS ECG MonitoringTMS60 Operator’s Manual 9 - 139.3.2 Waveform SetupThe ECG leads waveforms displayed in the waveform area are defined as the displayinglead.The CS uses information from two leads to detect beats and to compute HR. These twoleads are referred to as the primary and secondary leads. In addition, for Mortara ECGalgorithm, information from an additional lead (analysis lead) is made use of to classifythe beats (normal, abnormal etc). The user can select any of the available leads (depend-ing on whether a 3 or 5 lead cable is used) as primary, secondary or other analysis leads.For best results, the following guidelines should be used:■The QRS complex should be tall, narrow and preferably either completely above orbelow the baseline. If at all possible, avoid selecting a lead where the QRS complexis biphasic.■The P-waves and T-waves should be small compared to the QRS. They should beless than about 0.2 mV.9.3.2.1 Changing the Setting for Analysis Leads and Displaying LeadsThe default system setting for the analysis leads and displaying leads is [On], whichmeans that the analysis leads are consistent with the displaying leads. You can changethe default setting as following steps, if necessary. 1. At the CS, click [Admin Setup] → input the password → [OK].2. In the [Admin Setup] menu, click the [Telemetr y] tab.3. On the left side of the [Telemetry] tab, click [Analysis Lead Setting].The corresponding setting displays to the right of [Telemetr y].4. Set [Consistent with Displayed Lead] to [On] or [Off].◆[On]: the analysis lead is the same as the displaying lead.◆[Off]: the analysis lead is different from the displaying lead.HR Record on Alarm Select whether or not to activate the option to direct the CS to send the HR alarm data to the configured recorder.On, OffWaveform Setup Select to display the [Waveform Setup] menu.Refer to "Waveform Setup" on page 9 - 13 for details.Other Settings Select to display the [Other Settings] menu.Refer to "Other Settings" on page 9 - 15 for details.Options or Buttons Description Settings** The factory default settings are in bold.
ECG Monitoring Monitoring with the TD60 at the CS9 - 14 TMS60 Operator’s Manual9.3.2.2 Changing ECG Wave SettingsIn the [Waveform Setup] menu, you can configure the displaying leads and analysisleads as desired. The lead settings are dependent on the setting of [Analysis Lead Set-ting].■When [Analysis Lead Setting] is set to [On], the ECG waveform configurations areapplied for the displaying leads and analysis leads. Follow the steps below to con-figure the ECG waveform setting:1. In the [HR] section of the [ECG] tab, click [Waveform Setup].The [Waveform Setup] menu displays.2. Select the options described in the following table to configure the ECG waveforms.3. Click [Exit] to save the settings and close the [Waveform Setup] menu.■When [Analysis Lead Setting] is set to [Off], the displaying leads and analysisleads should be configured respectively. Follow the steps below to configure theECG waveform setting:1. In the [HR] section of the [ECG] tab, click [Waveform Setup].The [Waveform Setup] menu displays.2. Select the options described in the following table to configure the ECG waveforms.Options DescriptionSettings*Lead Waveform sizeECG 1 Select the desired ECG lead and set the corresponding gain for ECG 1.I, II, III, aVR, aVL, aVF, V× 0.125, × 0.25, × 0.5, × 1, × 2, × 4ECG 2 Select the desired ECG lead and set the corresponding gain for ECG 2.I, II, III, aVR, aVL, aVF, V× 0.125, × 0.25, × 0.5, × 1, × 2, × 4ECG 3 Select the desired ECG lead and set the corresponding gain for ECG 3.I, II, III, aVR, aVL, aVF, V× 0.125, × 0.25, × 0.5, × 1, × 2, and × 4* The factory default settings are in bold.
Monitoring with the TD60 at the CS ECG MonitoringTMS60 Operator’s Manual 9 - 153. Click [Exit] to save the settings and close the [Waveform Setup] menu.9.3.3 Other Settings The following table lists all settings in the [Other Settings] menu.Options DescriptionSettings*Lead Waveform sizeECG 1 Select the desired ECG lead and set the corresponding gain for ECG 1 to display in the waveform area.I, II, III, aVR, aVL, aVF, V× 0.125, × 0.25, × 0.5, × 1, × 2, × 4ECG 2 Select the desired ECG lead and set the corresponding gain for ECG 2 to display in the waveform area.I, II, III, aVR, aVL, aVF, V× 0.125, × 0.25, × 0.5, × 1, × 2, × 4ECG 3 Select the desired ECG lead and set the corresponding gain for ECG 3 to display in the waveform area.I, II, III, aVR, aVL, aVF, V× 0.125, × 0.25, × 0.5, × 1, × 2, × 4Primary lead Configures the primary analysis lead. I, II, III, aVR, aVL, aVF, VNoneSecondary lead Configures the secondary analysis lead. I, II, III, aVR, aVL, aVF, VNoneClassification lead (only for Mortara ECG algorithm)Configures other analysis lead. I, II, III, aVR, aVL, aVF, VNone* The factory default settings are in bold.Options Description Settings*Paced The option is unavailable at the CS. The paced status can be set at the TD60 only. Refer to "Checking the Paced Status" on page 7 - 10 for details.Pacer Reject Configures whether or not to reject the pace pulses.■[On]: the pace pulses are not countedas extra QRS complexes.■[Off]: the pace pulses are not rejected.On, OffThis [Pacer Reject] option is only available when [Paced] is set to [Yes ] at the TD60.* The factory default settings are in bold.
ECG Monitoring Monitoring with the TD60 at the CS9 - 16 TMS60 Operator’s Manual9.3.4 ECG Display9.3.4.1 ECG Digital AreaThe ECG digital area displays:1. Area name2. HR value3. High HR alarm limit4. Low HR alarm limit5. Pauses threshold6. Pauses per minute value7. Pauses per minute label8. PVCs threshold9. PVCs per minute value10. PVCs per minute labelECG digital areaFilter Configures the ECG filter in all operating modes.■[Monitor]: use under normalmeasurement conditions.■[ST]: use when the ST monitoring isapplied.Monitor, STOptions Description Settings** The factory default settings are in bold.12345678910
Monitoring with the TD60 at the CS ECG MonitoringTMS60 Operator’s Manual 9 - 179.3.4.2 ECG Waveform AreaThe ECG waveform area displays:1. ECG Lead2. ECG waveform size3. ECG filter setting4. Notch filter setting5. ECG waveform6. ECG scaleECG waveform areaNOTE•If the Activation State for HR, PVCs or Pauses alarm is set to [Off], the   symbol displays to the right of corresponding parameter.1234 56
QT Monitoring Monitoring with the TD60 at the CS9 - 18 TMS60 Operator’s Manual9.4 QT MonitoringA normal ECG waveform (as shown in the following figure) typically includes a sharp andwell defined QRS complexes with consistent spacing between R waves, and an ECGbaseline that is free of noise and artifact.A normal ECG waveform (for QT monitoring)The QT interval in an ECG lead is the time interval from the onset of the earliest deflec-tion in the QRS complex to the end of the T wave. QT monitoring can assist in the detec-tion of prolonged QT interval syndrome. 9.4.1 Measurement Limitations■At least one measured V-lead must be available in order for the algorithm toprocess QT.■QT/QTc values are calculated with 3-leadwire or 5-leadwire ECG cables.9.4.2 QT SettingsThe following table lists the QT settings in the [QT Analysis] section of the [ECG] tab.ST PointJ PointISO PointRTQT IntervalPQSOptions Description Settings*QT Analysis Enables or disables QT analysis. On, Off* The factory default settings are in bold.
Monitoring with the TD60 at the CS QT MonitoringTMS60 Operator’s Manual 9 - 19QT Computational FormulaConfigures the QTc formula used.Bazett: Fridericia: Framingham: Hodges: QT Alarm Setup Configures the QT alarms. ■For details about the QT alarms limits, refer to "Factory Default Parameter Alarm Limits" on page 9 - 3 for details.■For details about the QT alarms responses, refer to "Factory Default Parameter Alarm Settings" on page 9 - 5 for details.■For Mindray algorithm, you can configure the QTc and ∆QTc alarm.■For Mortara algorithm, you can configure the QTc alarms.QT View Select to display the [QT View] menu.Refer to "QT View Menu (Only for Mindray ECG Algorithm)" on page 9 - 20 for details.This button is only available for the Mindray ECG algorithm.Options Description Settings** The factory default settings are in bold.QTc QT QTHR60-------------12/×=QTc QT QTHR60-------------13/×=QTc QT154 1 60QTHR-------------–×+=QTc QT1.75QTHR60–()×+=
QT Monitoring Monitoring with the TD60 at the CS9 - 20 TMS60 Operator’s Manual9.4.3 QT View Menu (Only for Mindray ECG Algorithm)In the [QT View] menu, you can view a snapshot of the real-time wave and to verify thatthe QT algorithm detects correct Q and T points.The [QT View] menu displays, as shown in the following figure:◆The current waveform and parameter values display in green.◆The template waveform and parameter values display in yellow.◆The Q and T points are marked with a vertical line.◆The  ∆QTc value is equal to the current QTc value minus the template QTcvalue.QT View menuUsing the buttons described in the following table as desired.Buttons Description Settings*Lead Select the desired lead to display on the [QT View] menu screen.II, I, III, aVR, aVL, aVF, VSet as Ref. Replaces the template waveform and QT/QTc values with the current waveform and QT/QTc values.NoneThe QT template updated time displays at the bottom of the screen.Print Prints the template and current wave-forms, and QT/QTc values for all leads.NoneExit Closes the [QT View] Menu. None* The factory default settings are in bold.
Monitoring with the TD60 at the CS QT MonitoringTMS60 Operator’s Manual 9 - 219.4.4 QT DisplayWhen [QT Analysis] is enabled, the QT digital area displays:1. Area name2. QTc value3. High QTc alarm limit4. Activation State Off symbol for QTc alarm5. ∆QTc label6. ∆QTc value7. High ∆QTc alarm limit8. Activation State Off icon for ∆QTc alarm9. QT value10. QT label11. QTc label12. QT-HR label13. QT-HR valueExample QT digital area (for Mindray ECG algorithm)Example QT digital area (for Mortara algorithm)123456781011912 13
ST Monitoring Monitoring with the TD60 at the CS9 - 22 TMS60 Operator’s Manual9.5 ST MonitoringA normal ECG waveform (for ST monitoring)The ST segment of an ECG waveform (as shown in the above figure) represents theperiod from the end of ventricular de-polarization, to the beginning of ventricular re-polarization, or the end of the QRS complex (the J point) and the beginning of the T-wave. ST Segment analysis is used to monitor the oxygen supply and the viability of theheart muscle.ST deviation is the vertical distance between the isoelectric (ISO) point level and signallevel at ST point.The ISO point is located between the end of the P-wave and the onset of the QRS com-plex. The ISO point provides the baseline for this measurement.The ST point is a fixed distance from the J point at the end of the QRS complex. The STpoint can be configured to 40, 60, or 80 milliseconds past the J-point, independent ofthe heart rate. By default, the ST point is positioned as follows:■at 80 milliseconds for heart rates less than or equal to 120 beats per minute■at 60 milliseconds for heart rates greater than 120 beats per minuteAll available ECG leads are analyzed to measure deviations in the ST segment.Selecting leads that contain the least amount of baseline flutter will improve measure-ment accuracy, but accurate ST deviation measurement is dependent on the correctlocation of the ISO and ST points.■ST segment analysis calculates ST segment elevations and depressions forindividual leads and then displays them as numerics in the ST digital area.■A positive value indicates ST segment elevation; a negative value indicates STsegment depression.RPTSST PointJ PointISO Point40 to 80 msecST deviationDepression or ElevationST Segment
Monitoring with the TD60 at the CS ST MonitoringTMS60 Operator’s Manual 9 - 239.5.1 Measurement Limitations■ST values may be affected by such factors as some drugs or metabolic andconduction disturbances.■Since ST is often calculated with a fixed delay from the J point, changes in heartrate may affect ST.■The ST algorithm has been tested for accuracy of the ST segment data. Thesignificance of the ST segment changes needs to be determined by a physician.9.5.2 ST SettingsThe following table lists the ST settings in the [ST Analysis] section of the [ECG] tab.WARNING•The ST algorithm has been tested for accuracy of the ST segment data. The significance of the ST segment changes need to be determined by a clinician.Options or Buttons Description Settings*ST Analysis Enables or disables ST analysis. On, OffIf [ST Analysis] is set to [On], the [Filter] option from the [Other Settings] menu is automatically set to [ST].Display ST Segments Select whether or not to display the ST segments in the waveform area.On, OffST Alarm Setup Configures the ST alarm settings. ■For details about the ST alarms limits, refer to  "Factory Default Parameter Alarm Limits" on page 9 - 3 for details.■For details about the ST alarms responses, refer to  "Factory Default Parameter Alarm Settings" on page 9 - 5 for details.Define ST Point Select to display the [Define ST Point] menu.Refer to "Adjusting ST Measure-ment Points" on page 9 - 24 for details.This button is only available when [ST Analysis] is set to [On].* The factory default settings are in bold.
ST Monitoring Monitoring with the TD60 at the CS9 - 24 TMS60 Operator’s Manual9.5.3 Adjusting ST Measurement PointsThe ISO and ST points need to be adjusted when you start monitoring and if thepatient’s heart rate or ECG morphology changes significantly. Exceptional QRS com-plexes are not considered for ST-segment analysis.1. In the [ST Analysis] section of the [ECG] tab, click [Define ST Point].The [Define ST Point] menu displays, as shown in the following figure.Define ST point menu2. Adjust the parameter using the buttons described in the following table.WARNING•Always make sure that the ST measurement points are appropriate for your patient.Buttons Description Settings*Lead Select the desired ECG lead. I, II, III, aVR, aVL, aVF, VST (ms) Based on the ms setting selected, moves the ST point further or closer to the J point in the ST template.J+40, J+60, J+80, J+60/80* The factory default settings are in bold.
Monitoring with the TD60 at the CS ST MonitoringTMS60 Operator’s Manual 9 - 253. Select the [OK] or [Cancel] button.◆The [OK] button saves the settings and closes the menu.◆The [Cancel] button closes the menu without saving the settings.9.5.4 ST DisplayWhen [ST Analysis] is enabled, the ST digital area displays:1. Area name 2. Activation State Off icon for ST alarm3. ST values4. Units of measure5. Lead identifierExample 5-lead ST digital areaISO/J Selecting [Auto] fixes the ISO and J/ST points.Selecting [Manual] allows the clinician to manually adjust ISO and J/ST points. Auto, ManualFor Mortara algorithm, the ISO and J/ST points can only be adjusted manually.ISO left arrow If [ISO/J] is set to manual, the button adjusts the ISO reference line to the left.ISO right arrow If [ISO/J] is set to manual, the button adjusts the ISO reference line to the right.J left arrow If [ISO/J] is set to manual, the button adjusts the J reference line to the left.J right arrow If [ISO/J] is set to manual, the button adjusts the J reference line to the right.Buttons Description Settings** The factory default settings are in bold.12453
ST Monitoring Monitoring with the TD60 at the CS9 - 26 TMS60 Operator’s Manual9.5.5 ST Segment DisplayWhen [Display ST Segments] is enabled, the ST segments display in the waveform area:1. Lead identifier2. ST markers (ISO, J/ST)3. ST value4. ECG scale3-lead ST segment5-lead ST segments1234
Monitoring with the TD60 at the CS Arrhythmia MonitoringTMS60 Operator’s Manual 9 - 279.6 Arrhythmia Monitoring9.6.1 Measurement Limitations■Since the arrhythmia detection algorithm sensitivity and specificity is less than100%, sometimes there may be some false arrhythmias detected and also sometrue arrhythmia events may not be detected. This is especially true when thesignal is noisy.■The ECG size and QRS width settings affect arrhythmia detection and heart ratecalculation sensitivity.■If QRS amplitude is low, the monitor might not be able to calculate HR and falseasystole may occur.■At the algorithm learning phase, arrhythmia detection may not be available.Therefore, closely monitor the patient’s condition during the learning phase andafter the learning phase to allow the algorithm to reach optimal detectionperformance.9.6.2 Understanding the Arrhythmia Events9.6.2.1 Mindray ECG AlgorithmWARNING•The arrhythmia analysis program is intended to detect ventricular arrhythmias. It is not designed to detect atrial or supraventricular arrhythmias. It may incorrectly identify the presence or absence of an arrhythmia. Therefore, a physician must analyze the arrhythmia infor-mation with other clinical findings.•Heart-rate reading may be affected by cardiac arrhythmias. Do not rely entirely on heart rate alarms when monitoring patients with arrhyth-mia. Always keep these patients under close surveillance.Arrhythmia message Description CategoryAsystole No QRS detected within the set time threshold in absence of ven-tricular fibrillation or chaotic signal.Lethal arrhythmiaVFib/VTac A fibrillatory wave for 6 consecutive seconds.A dominant rhythm of adjacent Vs and a HR > the V-Tac HR limit.VTac The consecutive PVCs ≥ Vtac PVCs limit, and the HR ≥ the Vtac rate limit.
Arrhythmia Monitoring Monitoring with the TD60 at the CS9 - 28 TMS60 Operator’s ManualVent. Brady The consecutive PVCs ≥ the Vbrd threshold and the ventricular HR < the Vbrd Rate threshold.Lethal arrhythmiaExtreme Tachy The heart rate is equal to or greater than the extreme tachycardia limit.Extreme Brady The heart rate is equal to or less than the extreme bradycardia limit.PVCs/min PVCs/min exceeds high limit. Nonlethal arrhythmiaR on T R on T detected in normal heartbeats.Run PVCs More than 2 consecutive PVCs.Couplet Paired PVCs detected in normal heartbeats.PVC One PVC detected in normal heartbeats.Vent. Rhythm The consecutive PVCs ≥ the Vbrd PVCs limit, and the HR ≥ Vbrd Rate limit but < the Vtac Rate limit.Bigeminy A dominant rhythm of N, V, N, V, N, V.Trigeminy A dominant rhythm of N, N, V,N, N, V, N, N, V.Tachy The average heart rate is equal to or greater than the tachycardia limit.Brady The average heart rate is equal to or less than the bradycardia limit.Pacer Not Pacing No pace pulse detected for 1.75 x average R-to-R intervals following a QRS complex (for paced patients only).Pacer Not Capture No QRS complex detected for 300 milliseconds following a pace pulse (for paced patients only).Missed Beat No beat detected for 1.75 x average R-R interval for HR <120, or No beat for 1 second with HR > 120 (for non-paced patients only), orNo beat detected for more than the set pause threshold.Multif. PVC Multiform PVCs detected in Multif. PVC's Window (which is adjust-able).Nonsus. Vtac The consecutive PVCs < the Vtac PVCs limit but > 2, and HR ≥ the Vtac Rate limit.Pause No QRS detected within the set time threshold of pause.AFib Continuously detect that the RR intervals of normal sinus beats irregular and no P wave of normal sinus beats.Irr. Rhythm Consistently irregular rhythm.Pauses/min The number of pauses detected per minute.Arrhythmia message Description Category
Monitoring with the TD60 at the CS Arrhythmia MonitoringTMS60 Operator’s Manual 9 - 299.6.2.2 Mortara ECG AlgorithmArrhythmia message Description CategoryAsystole No QRS complex detected within the set time threshold (in absence of ventricular fibrillation or chaotic signals).Lethal arrhythmiaVFib Ventricular fibrillation occurs and persists for 6 seconds.VTac Ventricular HR is greater or equal to the preset threshold and the number of consecutive PVCs is greater than the preset threshold.Extreme Tachy The heart rate is equal to or greater than the extreme tachycardia limit.Extreme Brady The heart rate is equal to or less than the extreme bradycardia limit.PVCs/min PVCs/min exceeds high limit. Nonlethal arrhythmiaR on T R on T is detected.Run PVCs More than 2 consecutive PVCs.Couplet Paired PVCs are detected.Vent. Rhythm Ventricular HR is less than the preset threshold and the number of PVCs is greater than or equal to 3.Bigeminy A dominant rhythm of N, V,N, V, N, V.Trigeminy A dominant rhythm of N, N, V,N, N, V, N, N, V.Tachy The HR is greater than the set tachycardia high limit.Brady The HR is less than the set bradycardia low limit.Pacer Not Pacing No pace pulse detected for (60×1000/pace rate +90) milliseconds following a QRS complex or a pacer pulse (for paced patients only).Pacer Not Capture No QRS complex detected for 300 milliseconds following a pace pulse (for paced patients only).Multif. PVC More than 2 PVCs of different forms occur in the predefined search window (3-31).Pause No beat detected for 1.75x average R-R interval for HR <120, orNo beat for 1 second with HR >120 (for non-paced patients only), orNo beat detected for more than the set pause threshold.Irr. Rhythm Consistently irregular rhythmPauses/min The number of pauses detected per minute.
Arrhythmia Monitoring Monitoring with the TD60 at the CS9 - 30 TMS60 Operator’s Manual9.6.3 Arrhythmia SettingsThe following table lists the arrhythmia settings in the [Arrhythmia Analysis] section ofthe [ECG] tab.9.6.4 RelearningA relearn can be done for arrhythmia, ST analysis, or for both simultaneously. The TD60 initiates the learning process for ST or Arrhythmia analysis after any of the fol-lowing:■TD60 power-up■Return to normal monitoring from the Standby mode■Enabling ST or Arrhythmia analysis■The lead has been changed in ECG 1 waveform (3 lead only)■Patient size changes■Selecting the Relearn button in the [Arrhythmia Analysis] sectionSelecting the Relearn button in the [Arrhythmia Analysis] section is recommendedafter one or more of the following:■ECG electrodes have been repositioned■Eight hours have passed since the last relearn■Significant changes occurred to the patient QRS complexOptions or Buttons Description Settings*Arrhythmia Alarms Configures the arrhythmia alarm settings. Refer to "Factory Default Arrhyth-mia Alarm Settings" on page 9 - 6 for details.Relearn Enables an arrhythmia relearning. Refer to "Relearning" on page 9 - 30 for details.QRS Threshold Settings Configures the QRS threshold. Refer to "Configuring the QRS Threshold" on page 9 - 31 for details.NOTE•ST Analysis must be turned on before it will relearn.
Monitoring with the TD60 at the CS Arrhythmia MonitoringTMS60 Operator’s Manual 9 - 31■Significant changes occurred to the patient ECG rhythm■A clinician has observed clinically questionable arrhythmia calls■“Learning” occurred during a Leads Off condition9.6.5 Configuring the QRS ThresholdThe minimum detection threshold is approximately 0.16 mV. In case the P waves are verytall, one might consider moving the minimum QRS detection threshold up to be abovethe level of the P waves, so events like ventricular standstill are not missed.Two horizontal lines (one below and one above the baseline) appear on the screen.These represent the current minimum detection threshold on the positive and negativesides of the baseline so manual adjustment for both positive and negative going QRS'scan be made. Using the commands provided, move the minimum detection thresholdup or down to ensure it is above the level of the P waves but below the peak of the R-wave. Since the P-wave height could vary a little from beat to beat, do not set the hori-zontal line representing the minimum detection threshold at or barely above the level ofthe peak of the P wave. Ensure that it is at least one or two millimeters above the peak ofthe P wave but below the peak of the R-wave.1. In the [Arrhythmia Analysis] section of the [ECG] tab, click [Minimum QRS Threshold].The [Minimum QRS Threshold] menu displays, as shown in the following figure.CAUTION•Initiate ECG relearning only during periods of normal rhythm and when the ECG signal is relatively noise-free. If ECG learning takes place during ventricular rhythm, the ectopics may be incorrectly learned as the nor-mal QRS complex. This may result in missed detection of subsequent events of V-Tach and V-Fib.
Arrhythmia Monitoring Monitoring with the TD60 at the CS9 - 32 TMS60 Operator’s ManualMinimum QRS Threshold menuThe current waveform displays the data of previous eight seconds. Use the buttons described in the following table as desired.2. Select the [OK] or [Cancel] button.◆Once the threshold is in the desired position, select the [OK] button to savethe settings and close the menu.◆To quit adjusting the threshold, select the [Cancel] button to close the menuwithout saving the settings.Buttons Description Settings*Gain Select the desired ECG waveform size. X1, X2, X4Refresh Displays the real-time waveform.Default Automatically sets the default threshold: 0.16 mV. or Manually adjust the minimum QRS detection threshold.Select the   button to move the threshold line above the P wave, or select the  button to move the threshold line down closer to the P wave.* The factory default settings are in bold.
Monitoring with the TD60 at the CS SpO2 MonitoringTMS60 Operator’s Manual 9 - 339.7 SpO2 MonitoringAt the CS, you can view and change the SpO2 settings in the [SpO2] tab of the [Parame-ter Setup] menu.For details about the [Parameter Setup] menu, refer to the BeneVision Central StationOperator’s Manual (P/N 046-005011-00).9.7.1 Measurement LimitationsRefer to "Measurement Limitations" on page 8 - 2 for details.9.7.2 SpO2 SettingsThe following table lists the SpO2 settings in the [SpO2] tab.Options Description Settings*Activation State Configures whether or not to enable the SpO2 alarm.On, OffAlarm Priority Configures the SpO2 alarm levels. High, MedRecord on Alarm Selects whether or not to activate the recorder when an SpO2 alarm is triggered.On, OffSweep Speed Configures the SpO2 waveform sweep speed.6.25 mm/s, 12.5 mm/s, 25.0 mm/s, 50.0 mm/sDesat Limit Activation StateConfigures whether or not to enable the SpO2 Desat alarm.On, OffSensitivity(Masimo only)The option is not configurable. The option setting is synchronous with the set-ting at the TD60. Refer to "Configuring the SpO2 Setup" on page 8 - 5.SpO2 High Limit (%)  Configures the SpO2 high alarm limit. (Low limit + 1) to 100The default is 100.SpO2 Low Limit (%) Configures the SpO2 low alarm limit. 0 to (high limit - 1)The default is 90.PR High Limit (bpm) Configures the PR high alarm limit. (Low limit + 2) to 300The default for adult is 120.The default for pediatric is 160.PR Low Limit (bpm) Configures the PR low alarm limit. 18 to (high limit - 2)The default for adult is 50.The default for pediatric is 75.* The factory default settings are in bold.
SpO2 Monitoring Monitoring with the TD60 at the CS9 - 34 TMS60 Operator’s Manual9.7.3 SpO2 Display9.7.3.1 SpO2 Digital AreaThe SpO2 digital area displays:1. Area name2. High SpO2 alarm limit3. PR label4. PR value5. High PR alarm limit6. SpO2 unit of measure7. Low PR alarm limit8. Masimo perfusion index value9. PI label10. Low SpO2 alarm limit11. SpO2 valueMasimo SpO2 digital areaDesat Limit (%) Configures the SpO2 Desat low limit. 0 to 100The default is 80.Averaging(Masimo only)The option is not configurable. The option setting is synchronous with the set-ting at the TD60. Refer to "Configuring the SpO2 Setup" on page 8 - 5 for details.Options Description Settings** The factory default settings are in bold.1234 567891011
Monitoring with the TD60 at the CS SpO2 MonitoringTMS60 Operator’s Manual 9 - 35Nonin SpO2 digital area9.7.3.2 SpO2 Waveform AreaThe SpO2 waveform area displays:1. Area name2. Pleth waveformSpO2 waveform areaNOTE•When [HR Source] of the [ECG] tab is set to [Both], the PR value displays on the SpO2 digital area.12
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TMS60 Operator’s Manual 10 - 110 Configuring the TD60Introduction...............................................................................................................10-2Maintenance Menu.................................................................................................10-2
Introduction Configuring the TD6010 - 2 TMS60 Operator’s Manual10.1 IntroductionThis TD60 Maintenance menu provides access to the system settings such as location,device name, alarm settings, quick keys, screen lock, and password updates. Enteringthis menu requires a password.10.2 Maintenance MenuThe [Maintenance] menu contains the following submenus:■General■Alarms■Quick Keys■Defaults■Screen Lock■Edit Passcodes■Device Name■Demo Mode■Service10.2.1 Entering the Maintenance menu1. In the main menu, tap [Maintenance].2. Input the maintenance password.3. Tap [Accept] to enter the [Maintenance] menu.10.2.2 Configuring the General MenuSelect [General] to configure the display auto off, language, location, notch filter, ECGlead labeling, SpO2 module, SpO2 tone, and enable or disable ECG calibration.1. In the [Maintenance] menu, tap [General].The current setting displays to the right of the option.2. Select the options described in the following table.Options  Description Settings*Display Auto Off Configures the time for display auto off. 1 min, 2 min, 5 min, 15 min 30 min, OffLanguage Configures the system language. ENGLISH, FRENCH* The factory default settings are in bold.
Configuring the TD60 Maintenance MenuTMS60 Operator’s Manual 10 - 33. Tap   to exit the [General] menu.10.2.3 Configuring the Alarms MenuSelect [Alarms] to configure the alarm tone, reminder tone, reminder interval, minimumalarm volume, and technical alarm priority.1. In the [Maintenance] menu, tap [Alarms].The current setting displays to the right of the option.2. Select the options described in the following table.Location Changes the hospital and department names.N/ANotch Filter Configures the ECG Notch filter. This option is used to filter out AC line noise from the ECG waveform.50 Hz, 60 Hz, OffThe default is 50 Hz when the device is not configured for the US.ECG Lead Labeling Changes the ECG lead labeling. AHA, IECCalibrate ECG Enables or disables the ECG verification. On, OffRefer to "Verifying the ECG at the TD60" on page 14 - 4 for details.SpO2 Module Changes the SpO2 module. Masimo, NoninSpO2 Tone Configures the SpO2 tone. Mode 1, Mode 2Options  Description Settings** The factory default settings are in bold.NOTE•Mindray recommends the same SpO2 tone mode be used for the devicewithin a monitoring area.Section & Options  Description Settings*SoundsStyle Allows an authorized user to set the alarm tone pattern.ISO, Mode 1, Mode 2* The factory default settings are in bold.
Maintenance Menu Configuring the TD6010 - 4 TMS60 Operator’s Manual3. Tap   to exit the [Alarms] menu.TimeoutReminder Tone Allows an authorized user to enable or disable the reminder tone.If the alarm tone is turned off, enabling this set-ting can issue a periodic reminder tone. On, OffReminder Interval Allows an authorized user to configure the intervals between the alarm tones.1 min, 2 min, 3 min, 5 min, 10 minMinimum Alarm VolumeTechnical Allows an authorized user to set the minimum technical alarm volume.The minimum technical alarm volume defines the minimum value you can set for the techni-cal alarm volume.For example:If the minimum technical alarm volume is set to 5, the minimum value you can set for the tech-nical alarm volume in the [Audio Volume] menu is 5 (as shown in the following figure).If the minimum technical alarm volume is set to Off, and the technical alarm volume can be set to 0, the alarm sound is turned off and the   symbol appears on the screen.Off, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10Technical Alarm PriorityECG Lead Off Allows an authorized user to configure the alarm level.Low, Medium, HighSpO2 Sensor Off Allows an authorized user to configure the alarm level.Low, Medium, HighSection & Options  Description Settings** The factory default settings are in bold.Minimum value
Configuring the TD60 Maintenance MenuTMS60 Operator’s Manual 10 - 510.2.4 Quick Keys Menu10.2.4.1 Changing the Quick Keys1. In the [Maintenance] menu, tap [Quick Keys].The [Quick Keys] configuration menu displays.2. From the quick keys area at the bottom of the screen, tap a quick key you want to configure.A list of option displays. WARNING•When the technical alarm audio volume is set to alarm sound and thealarm sound is turned off, the TD60 will not enunciate technical alarmswhen they occur. Be careful when turning off the alarm volume.•Do not rely exclusively on the audible alarm system for monitoring.Adjustment of alarm volume to a low level may result in a hazard to thepatient. Always keep the patient under close surveillance.
Maintenance Menu Configuring the TD6010 - 6 TMS60 Operator’s Manual3. Tap the desired option from the list of options to configure the selected quick key.4. Repeat steps 2 to 3 to configure other quick keys, if needed.5. Tap   to exit the [Quick Keys] menu.10.2.4.2 Deleting a Quick Key1. From the quick keys area at the bottom of the [Quick Keys] menu, press and hold the desired quick key for two seconds, and then release it.The quick key background turns to red and displays [Delete].2. Tap [Delete].The quick key is removed from the quick keys area, and the area displays [Not Used].3. Tap   to exit the [Quick Keys] menu.10.2.5 Configuring the Defaults MenuThe [Defaults] menu allows an authorized user to manage the system configurations.1. In the [Maintenance] menu, tap [Defaults].2. Select the options described in the following table.A list of optionsOptions  DescriptionSave Departmental Defaults Allows an authorized user to save the current device settings for the selected patient category.Export Device Settings Copies the user configuration to the external device.
Configuring the TD60 Maintenance MenuTMS60 Operator’s Manual 10 - 73. Tap   to exit the [Defaults] menu.10.2.6 Transferring a ConfigurationThe TD60 is capable of configuring multiple devices through one export operation via awireless interface.To transfer the configuration from the TD60 unit to an external device:1. In the [Maintenance] menu of an external device, tap [Defaults] → [Import Device Settings] to enter the settings import mode.2. In the [Maintenance] menu of the TD60 unit, tap [Defaults] → [Export Device Settings] to enter the [Export Device Settings] menu.The discovered external devices are listed in the [Export Device Settings] menu.3. Select the desired external devices by tapping the check box.4. Tap [Export] to start exporting the TD60 unit configuration.The selected external devices screen will shortly display the “Downloading device settings” message.■On the external devices if an import is successful, the external device will displaythe “Download complete.” message, and after 10 seconds return to the [Defaults]menu. On the TD60 unit, the status for the external device will display the“Complete” message.■On the external device if the import fails, the external device will display the“Import attempt failed.” message. On the TD60 unit, the status for the failedexternal device will display the “Failure” message and remain in the list. The user has two options when a failure occurs:◆To stop the import from the external device, tap the   icon to exit the[Import Device Settings].Import Device Settings Copies the settings from the external device to theTD60 unit. Refer to "Trans-ferring a Configuration" on page 10 - 7 for details.Restore Factory Defaults Allows an authorized user to reestablish the original database power up settings to factory default values.Options  DescriptionWARNING•Do not power off the devices during the download process.
Maintenance Menu Configuring the TD6010 - 8 TMS60 Operator’s Manual◆To retry the import from the TD60 unit, tap the external device which is dis-playing the [Failure] message, tap the [Retry] button to restart the transfer.You may need to repeat the retry operation several times until the transfer issuccessful.10.2.7 Screen Lock Menu10.2.7.1 Understanding the Screen Lock ModeThere are two modes of being able to lock the screen to assist in preventing unauthor-ized use. Each mode allows the user access to certain features of the product withoutentering a passcode. When the correct passcode is entered, all features are available.■Locked Mode Features:◆Main screen and main menu are not accessible without passcode entry.◆The message area is still viewable.◆Hardkeys are enabled.■View Only Features:◆Upon powering up, the main screen will be displayed after the new patientchoice is made.◆Main Screen is accessible without passcode entry.◆The [System Info] menu is accessible by tapping the battery symbol on themain screen.◆The [Lead Placement] menu is accessible by tapping an “ECG Lead Off”message in the message area.◆Ability to change display orientation.◆Hardkeys are enabled.10.2.7.2 Setting the Screen LockThe initial enabling of screen lock mode requires a passcode to be entered immediatelyas follows:1. In the [Maintenance] menu, tap [Screen Lock] to select a screen lock mode.2. Enter a new passcode for the screen lock.After the passcode is entered, the screen exits the passcode setup menu. The selected lock mode displays to the right of [Screen Lock].
Configuring the TD60 Maintenance MenuTMS60 Operator’s Manual 10 - 910.2.7.3 Changing the Current Screen Lock Passcode1. In the [Maintenance] menu, tap [Screen Lock].2. Tap [Screen Lock Passcode].3. Input the current password.4. Input and verify the new password10.2.8 Changing the Passwords1. In the [Maintenance] menu, tap [Edit Passwords].◆Tap [Maintenance Password] and follow the on-screen instructions tochange the maintenance password.◆Tap [Service Password] and follow the on-screen instructions to change theservice password.2. Tap the   icon to exit the [Edit Passwords] menu.10.2.9 Changing the Device Name1. In the [Maintenance] menu, tap [Device Name].2. Use the on-screen keyboard to input the device name.3. Tap [Accept] to save the setting and exit the [Device Name] menu.10.2.10 Demo ModeAllows an authorized user to choose a demonstration mode for in-servicing staff or test-ing product features. 10.2.11 Service MenuAllows an authorized user access to the passcode protected Service menu.NOTE•Do not set the same device name for the TD60s.
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TMS60 Operator’s Manual 11 - 111 BatteryIntroduction...............................................................................................................11-2Safety............................................................................................................................11-2Installing the Battery ..............................................................................................11-3Checking the Battery Charge Status.................................................................11-4Removing the Battery ............................................................................................11-4Charging the Rechargeable Lithium-ion Battery .........................................11-5Storing the Batteries...............................................................................................11-6Maintaining the Rechargeable Lithium-ion Battery....................................11-7Disposing of the Batteries.....................................................................................11-8
Introduction Battery11 - 2 TMS60 Operator’s Manual11.1 IntroductionThe TD60 can be powered by a lithium-ion rechargeable battery or AA batteries. This chapter provides instructions on how to use, maintain, and dispose of the batteries.11.2 SafetySEWARNING•Keep the batteries out of children’s reach.•Keep the batteries in their original package until you are ready to use them.•The battery compartment should be closed during defibrillation.•Only use specified AA batteries or rechargeable lithium-ion battery to power the TD60. Other power supply may cause damage to the equipment or lead to body injury.•While installing AA batteries, do not apply reverse polarity.•Only use specified fresh AA batteries. Using other AA batteries can give unacceptable performance.•Do not mix old and new AA batteries.•Only use specified rechargeable lithium-ion battery. Unspecified lithium-ion battery can give unacceptable performance.•Use caution when handling the rechargeable lithium-ion battery. Misuse or abuse may cause bodily injury or device damage.◆Do not short circuit. Take care that the terminals do not contactmetal or other conductive materials during transport and storage.◆Do not crush, drop or puncture the battery. Mechanical abuse canlead to internal damage and internal short circuits. If a battery hasbeen dropped or banged against a hard surface, whether damageis externally visible or not, remove the battery from use and dis-pose of it properly.◆Do not incinerate batteries or expose them to temperatures above60°C (140°F).•The rechargeable lithium-ion batteries should be charged in the specified central charger.
Battery Installing the BatteryTMS60 Operator’s Manual 11 - 311.3 Installing the BatteryRefer to "Installing the Batteries" on page 3 - 5 for details.WARNING•If a battery shows signs of damage or signs of leakage, replace it immediately. Use caution in removing the battery. Avoid contact with skin. Refer to qualified service personnel.•Some failure conditions, such as short circuits, can cause a battery to overheat during using. High temperature can cause burns to the patient or user. If the device becomes too hot to the touch, remove it from the patient and place aside until it cools. Then remove the battery from the device, and contact your service personnel to identify the cause of overheating.•Replace the battery immediately once the “Critically Low Battery” alarm message displays. Replace the battery in time once the “Low Battery” alarm message displays. If those conditions are not corrected, device shutdown and cessation of monitoring will result.•To eliminate the risk of electrical shock or burn, do not carry loose batteries on your person, such as placing the battery in clothing pockets.CAUTION•Remove the battery before transporting the device or if the device is not in use or is being stored.•AA batteries should be removed from the device at the end of the battery’s useful life to prevent leakage. In case of battery leakage, use caution to remove the batteries and clean the battery compartment. Install fresh AA batteries and check if the TD60 can power on properly. If the TD60 fails to power on, contact your service personnel.
Checking the Battery Charge Status Battery11 - 4 TMS60 Operator’s Manual11.4 Checking the Battery Charge StatusThe battery symbol displaying on the top of main screen indicates the battery charge status. The white part ( ) indicates the remaining battery charge.11.5 Removing the Battery1. Lift up the lithium-ion battery pack or AA battery tray at the bottom of the TD60.NOTE•If the “Low Battery” or “Critically Low Battery” alarm occurs, the TD60 turns off the audio, the screen display the “Local Audio Off” message, and the screen brightness turns dimmer.CAUTION•Some failure conditions, such as short circuits, can cause a battery to overheat during using. High temperature can cause burns to the patient or user. If the device becomes too hot to the touch, remove it from the patient and place aside until it cools. Then remove the battery from the device, and contact your service personnel to identify the cause of overheating.•Avoid scraping the metal contact in the battery compartment while removing the lithium-ion battery pack or AA battery frame. Otherwise, the broken contact will affect the power supply performance.•Remove the battery before transporting the device or if the device is not in use or is being stored.NOTE•Retain the ECG cable and SpO2 module with the device while removing the battery.
Battery Charging the Rechargeable Lithium-ion BatteryTMS60 Operator’s Manual 11 - 52. Remove the lithium-ion battery pack or AA battery tray from the TD60.11.6 Charging the Rechargeable Lithium-ion BatteryUse the central charger to charge the lithium-ion batteries. The central charger can charge 10 lithium-ion batteries at one time. For details about the central charger, refer to the BeneVision Central Charger Operator’s Manual (P/N 046-007059-00).WARNING•Only use the specified central charger to charge to the lithium-ion batteries designated by Mindray.•Only use the approved power cord with the grounded mains plug to firmly connect the central charger to a grounded AC mains socket. Never refit the mains plug to fit an ungrounded AC mains socket.•Do not use the Multiple Portable Socket Outlets (MPSO) or AC mains extension cords. Use an IEC 60601-1 approved isolation / separation transformer, otherwise, it may result in leakage current. Insure that the sum of the individual ground leakage currents does not exceed the allowable limits. •Do not place any shield object (such as cloth or paper) to cover the central charger or batteries, and keep ventilated while charging the lithium-ion batteries.•Do not connect other devices to the power supply system.•Do not use the central charger to charge the lithium-ion batteries in high temperature above 40°C.
Storing the Batteries Battery11 - 6 TMS60 Operator’s Manual11.7 Storing the Batteries11.7.1 Storing Rechargeable Lithium-ion Battery When storing batteries, make sure that the battery terminals do not come into contact with metallic objects. If you need to store the batteries for an extended period of time, place the batteries in a cool, dry place (ideally at 15°C or 60°F) with a partial charge of about 50% capacity (two LEDs illuminated). Storing batteries in a cool place can slow the aging process.Stored batteries should be charged to about 50% of their capacity every six months. The battery should be fully charged prior to first use.11.7.2 Storing AA BatteriesIf you remove undepleted AA batteries from the TD60 and need to store the batteries, keep the batteries together as a set for later re-use so that all batteries will have the same level of remaining power.Do not store disposable AA batteries by leaving the batteries in the incorrect polarity position in the TD60.NOTE•Remove the lithium-ion battery from the device if the device is not used for a prolonged time (for example, several weeks), and keep the device in clean place to avoid the dust or liquid entering the battery compartment.•Storing batteries at high temperatures for an extended period of time will significantly shorten their life expectancy. •Do not store the batteries in an environment above 60°C (122°F) or lower than -20°C (4°F).
Battery Maintaining the Rechargeable Lithium-ion BatteryTMS60 Operator’s Manual 11 - 711.8 Maintaining the Rechargeable Lithium-ion BatteryTake care of the rechargeable lithium-ion battery once you receive a new battery for use. The following table describes the battery maintenance activities and recommended frequency.The lifetime of a lithium-ion battery depends on the frequency and duration of use. With good maintenance, the useful life is approximately four years or 500 complete charge-discharge cycles. In addtion, experience indicates that the incidence of failure may increase with battery service life due to the accumulated stresses of daily use. Therefore, Mindray strongly recommend that lithium-ion battery should be replaced after two years or 300 complete charge-discharge cycles. Using the outdated battery may cause the device abnormity and unacceptable performance.The age of a lithium-ion battery begins at the date of manufacture. The date of manufacture is listed on the rear of the battery.NOTE•Replace the AA battery frame on the battery compartment after removing the AA batteries.Activity Recommended FrequencyVisual inspection Before installing a battery in the TD60.Charge the battery Upon receipt, after use, a “Low Battery” or “Critically Low Bat-tery” alarm occurs. To optimize performance, a fully or almost fully discharged battery must be charged immediately.Clean the battery At each patient discharge, or in case that the battery is exposed to contaminants.Do not clean the battery connector during the cleaning.Charge stored battery to at least 40% of the battery capacity.Every six months if the TD60 is not in use for an extended period of time.Dispose of the battery When the “Battery Maintenance Required” alarm message displays on the TD60.
Disposing of the Batteries Battery11 - 8 TMS60 Operator’s Manual11.9 Disposing of the Batteries11.9.1 Disposing of the Rechargeable Lithium-ion BatteryDiscard the lithium-ion battery in the following situations:■The battery has visual signs of damage.■The battery fails.■The battery is aged and its runtime significantly less than the specification.■The battery has been used for more than two years or 500 complete charge-dis-charge circles.Discharge the battery and insulate the terminals with tape before disposal. Properly dispose of the batteries according to local regulations.11.9.2 Disposing of the AA BatteriesThe batteries may be subject to local regulations regarding disposal. Dispose of batteries in approved containers. Follow local regulations, if any, to recycle the batteries.NOTE•The battery capacity degrades as using time and number of recharge cycles.Toward the end of its useful life, the battery capacity may be reduced by 20% to 25%. If the reduced battery life is unacceptable for your device, Mindray recommends the battery be replaced.
TMS60 Operator’s Manual 12 - 112 TroubleshootingGeneral Problems ....................................................................................................12-2Physiological Alarm Messages at the CS .........................................................12-3Technical Alarm Messages at the TD60 ...........................................................12-5
General Problems Troubleshooting12 - 2 TMS60 Operator’s Manual12.1 General ProblemsThe following table lists the problems that are likely to occur. If the problem persists aftercorrective actions have been taken, contact your service personnel.12.1.1 Troubleshooting Tools■Telemetry Receiver (RC60)■TD60■Central Station (CS)12.1.2 Problem ListSymptom Possible cause SolutionNo RF Signal (The RC60 does not receive valid data for consecutive 5 seconds)1. The TD60 battery charge is to be depleted.2. The patient is out of the antenna array coverage area.3. The TD60 is not connected with the ECG leadwire.1. Check if the TD60 battery charge is depleted.2. Check if the patient is out of the coverage area.3. Check if the TD60 is connected with the ECG leadwire properly.RF Interference (The TD60 receives three consecutive wrong frames.)The TD60 signal is weak. Check if the Patient is at the edge of the coverage area or in an elevator. Remove behind a reinforced concrete wall.SpO2 No Pulse The SpO2 sensor failed to obtain pulse signal.Check the patient’s condition and change the sensor application site. If the error persists, replace the sensor.The CS does not display the SpO2 data.1. The SpO2 module is not con-nected to the TD60.2. There may be error in the SpO2 module.1. Connect the SpO2 module to the TD60.2. If there is an error in the SpO2 module, replace the SpO2 mod-ule with a new one.ECG noise ECG waveforms are overlapped with the noise interference.Check if the ECG leadwire is intertwined with cables of other devices.ECG Signal Saturated The TD60 detects that ECG signal saturation or overload.1. Check if patient has excessive movement.2. Check if the electrodes are in good contact with the skin.3. Check if the electrodes operat-ing time is over the electrode service life.Wrong Channel The configured frequency of the transmitter does not match the channel.Reconfigure the frequency of the transmitter to match the channel.
Troubleshooting Physiological Alarm Messages at the CSTMS60 Operator’s Manual 12 - 312.2 Physiological Alarm Messages at the CSThe following table lists the major telemetry-related physiological alarm messages dis-played on the central station (CS) screen. The AC power indicator on the RC60 is off.1. The RC60 is not connected to the power.2. The RC60 is power off.1. Check if the  RC60 is connected to the power.2. Check if the RC60 sounds a beep when turn the receiver on.The TD60 or SpO2 module restarts repeatedly. The TD60 battery charge is to be depleted.Replace with new batteries.Symptom Possible cause SolutionMeasurement Alarm message Alarm level Possible cause SolutionHeart rate (HR) HR High Medium* HR value has risen above the high alarm limit or fallen below the low alarm limit.Check the patient’s condition and make sure that the patient category and alarm limit settings are correct.HR Low Medium** The asterisk (*) means the alarm level is configurable.
Physiological Alarm Messages at the CS Troubleshooting12 - 4 TMS60 Operator’s ManualECG ECG Weak Signal High The ECG signal is so weak that the monitor can’t perform ECG analysis.Check the patient’s condition and the ECG connections.Asystole High The patient is in arrhythmia.Check the patient’s condition and the ECG connections.Vfib/Vtac HighVTac HighVent. Brady HighExtreme Tachy HighExtreme Brady HighR on T Medium*VT > 2 Low*Couplet Message*PVC Message*PVCs/min Medium*Bigeminy Medium*Trigeminy Medium*Tachy Medium*Brady Medium*Missed Beat Message*Vent. Rhythm Medium*Pause Medium*PNP (Pacer Not Pacing)Message* The pacer appears abnormal.Check the pacer.PNC (Pacer Not Capture)Message*Measurement Alarm message Alarm level Possible cause Solution* The asterisk (*) means the alarm level is configurable.
Troubleshooting Technical Alarm Messages at the TD60TMS60 Operator’s Manual 12 - 512.3 Technical Alarm Messages at the TD60The following table lists the major technical alarm messages displayed in the messagearea of the TD60.The Alarm Indication column in the table below is capable of three different indicationtypes: A, B, C. ■A: The alarm sound will be silenced, the alarm light will continue to indicate the alarm, a √ will appear before the alarm message. The   symbol appears on the top of the main screen.■B: The technical alarm will be changed to the prompt message, it will not longer make sound or be indicated by the alarm light.■C: The technical alarms are cleared, there will be no alarm indications.SpO2SpO2 Desat High The SpO2 value has fallen below the desaturation alarm limit.Check the patient’s condition and check if the alarm limit settings are correct.No Pulse High The pulse signal was so weak that the monitor cannot perform pulse analysis.Check the patient’s condition, SpO2 sensor and measurement site.Measurement Alarm message Alarm level Possible cause Solution* The asterisk (*) means the alarm level is configurable.Measurement Alarm messageAlarm levelAlarm Indication Possible cause SolutionECG ECG Lead OffLow* B The electrode has become detached from the patient or the lead wire has become disconnected from the adapter cable.Check the connections of the electrodes and leadwires.ECG XX** Lead OffLow* BECG Module ErrorHigh A An error occurred to the ECG module.There is a problem with the communications between the module and the TD60.Restart the TD60. If the problem persists, contact your service personnel.* The asterisk (*) means the alarm level is configurable.** XX is the ECG lead name.
Technical Alarm Messages at the TD60 Troubleshooting12 - 6 TMS60 Operator’s ManualECG ECG NoiseLow A The ECG signal is noisy. Check for any possible sources of signal noise around the cable and electrode, and check the patient for great motion.ECG Cable Type ErrorLow B Connect wrong ECG leadwire.Reconnect the 3 or 5 lead ECG leadwire.HR OverrangeLow A HR exceeds the measurement limit.Contact your medical pesonnel.SpO2SpO2 Sensor OffLow* B The SpO2 sensor has become detached from the patient or the module. There is a fault with the SpO2 sensor. An unspecified SpO2 sensor has been used.Check the sensor application site and the sensor type, and make sure the sensor is not damaged.Reconnect the sensor or use a new sensor.SpO2 Sensor FaultLow CSpO2 No SensorLow BSpO2 Module ErrorHigh ASpO2 Too Much LightLow A There is too much light on the SpO2 sensor.Move the sensor to a place with lower level of ambient light or cover the sensor to minimize the ambient light.SpO2 No PulseLow A SpO2 sensor failed to obtain pulse signal.Move the sensor to a site with better perfusion.SpO2 UnpluggedLow C SpO2 module connector is disconnected from the TD60.Reconnect the SpO2 module to the TD60.PR OverrangeLow A The measured PR value exceeds the measurement range.Contact Mindray or your service personnel.Measurement Alarm messageAlarm levelAlarm Indication Possible cause Solution* The asterisk (*) means the alarm level is configurable.** XX is the ECG lead name.
Troubleshooting Technical Alarm Messages at the TD60TMS60 Operator’s Manual 12 - 7Power Low BatteryMedium A The battery charge is low. Replace with new batteries.Critically Low BatteryHigh A The battery charge is almost depleted.Battery Maintenance RequiredMedium A The lithium-ion battery is aging.Battery ErrorMedium A The lithium-ion battery communication is error.Battery Type ErrorMedium A The battery contact is not making adequate connection. System Device ErrorHigh A The selftest of the TD60 main board is error.The selftest of the parameter module or Mindray PAN module are error.The parameter module communication is error or initialization is error.Restart the TD60. If the problem persists, contact your service personnel.Real Time Clock ErrorHigh A The real time clock initialization is error.Restoring Last Defaults FailedLow C Restoring the last default configuration is error.Loading Defaults FailedLow C Loading the default configuration is error.Measurement Alarm messageAlarm levelAlarm Indication Possible cause Solution* The asterisk (*) means the alarm level is configurable.** XX is the ECG lead name.
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TMS60 Operator’s Manual 13 - 113 Cleaning and DisinfectingIntroduction...............................................................................................................13-2Safety Information...................................................................................................13-2Cleaning of the TD60..............................................................................................13-3Cleaning the Reusable ECG Leadwires, SpO2 Modules and Sensors....13-4Cleaning the Battery and Battery Compartment .........................................13-5Disinfection................................................................................................................13-5Sterilization ................................................................................................................13-5
Introduction Cleaning and Disinfecting13 - 2 TMS60 Operator’s Manual13.1 IntroductionOnly use the substances approved by Mindray and methods listed in this chapter toclean or disinfect your device. Our warranty does not cover damage caused by unap-proved substances or methods.Mindray makes no claims regarding the efficacy of the listed chemicals or methods as ameans for controlling infection. For the method to control infection, consult your hospi-tal’s Infection Control Officer or Epidemiologist.13.2 Safety InformationWARNING•The responsible hospital or institution shall carry out all cleaning and disinfection procedures specified in this chapter.•Be sure to shut down the system before cleaning the equipment.•Non-medical equipment does not provide the same level of protection against electrical shock. Do not touch the patient and any part of non-medical equipment at the same time. Some examples of non-medical equipment are laser printers and nonmedical computers.•Avoid use of cleaners, materials or chemicals that may damage device surfaces, labels, or cause equipment failures.•Keep your equipment and accessories free of dust and dirt. To avoid damage to the equipment, follow these guidelines:◆Always dilute according to the manufacturer’s instructions or uselowest possible concentration.◆Do not immerse any part of the device into liquid. Do not pourliquid onto the equipment or accessories. ◆Do not allow liquid to enter the case and the device interior.◆Never use abrasive materials (such as steel wool or silver polish), orerosive cleaners (such as acetone or acetone-based cleaners).
Cleaning and Disinfecting Cleaning of the TD60TMS60 Operator’s Manual 13 - 313.3 Cleaning of the TD60Clean your equipment on a regular basis. Before cleaning the equipment, consult yourhospital’s regulations for cleaning the equipment. Recommended cleaning agent are:■Water■Mild soapBefore cleaning your TD60, do the following preparations:■Install the battery pack or battery tray to firmly close the battery compartment.■Insert the SpO2 cover in the SpO2 connector when SpO2 is not in use.■Insert the ECG leadwire plug into the ECG connector.To clean your TD60, follow this procedure:1. Shut down the device.CAUTION•If liquid has accidentally entered the system or its parts, shut down the system and have the device serviced by authorized service personnel.•Remove the equipment from use if liquid is spilled on the equipment or accessories. Contact your service personnel. •When cleaning, avoid the ECG leadwire connector and other connectors. CAUTION•Only use the following approved cleaning solutions. The system may become inoperable or halted because of contamination or damage caused by use of unapproved cleaning solution.WARNING•Never allow the cleaning solutions to spill or enter the plug, connector and battery compartment.
Cleaning the Reusable ECG Leadwires, SpO2 Modules and Sensors Cleaning and Disinfecting13 - 4 TMS60 Operator’s Manual2. Dilute the mild soap in water to make a cleaning solution.3. Soak a clean and soft cloth in the solution and wring out excess solution.4. Thoroughly wipe the display screen and the exterior surface of the device with the damp cloth, avoiding the connectors.5. Wipe off all the cleaning solution with a dry cloth if necessary.6. Dry your device in a ventilated, cool place.13.4 Cleaning the Reusable ECG Leadwires, SpO2 Mod-ules and Sensors■Check reusable sensors and cables daily for signs of damage. Replace as required.■Clean the sensors before and after each new patient.■Wipe sensors and cables using a soft cloth with mild soap and water solution.■Allow the cables and sensors to completely dry before using.Refer to the cleaning procedure described in "Cleaning of the TD60" on page 13 - 3.CAUTION•Never immerse cables and sensors in any fluids. Do not clean them with harsh chemicals such as acetone or non-diluted bleach.•Clean the cables carefully to avoid breaking internal wires by excessive bending, strain, or flexing.•Do not autoclave, radiation or steam sterilize the cables and sensors.•Extended exposure to Ethylene Oxide gas may shorten life of the cables, leading to poor signal quality.NOTE•Refer to the individual instruction sheets that are packaged with the accessories for additional information.
Cleaning and Disinfecting Cleaning the Battery and Battery CompartmentTMS60 Operator’s Manual 13 - 513.5 Cleaning the Battery and Battery Compartment■Clean the exterior surface of the lithium-ion battery pack and AA battery traybefore and after each new patient.■Wipe the lithium-ion battery pack, AA battery tray and the battery compartmentusing a soft cloth with mild soap and water solution. Use caution to avoid thebattery connector.■Allow the lithium-ion battery pack, AA battery tray and the battery compartmentcompletely dry before using.Refer to the cleaning procedure described in "Cleaning of the TD60" on page 13 - 3.13.6 DisinfectionDisinfect the TD60 and accessories as required in your hospital’s servicing schedule.Cleaning before disinfecting is recommended.The recommended disinfectants are:■70% isopropyl alcohol■10% sodium hypocholride (bleach) solution■3% hydrogen peroxide■Virkon■Super Sani-cloth (0.5% Quaternary ammonium chloride and 55% Isopropylalcohol)■50% propyl alcohol (1-propyl alcohol)■70% ethanol13.7 SterilizationSterilization is not recommended for this equipment, related products, accessories orsupplies unless otherwise indicated in the Operating Instructions that accompany theaccessories or supplies.CAUTION•Never immerse the lithium-ion battery pack, AA battery tray and AA batteries. Do not clean them with harsh chemicals such as acetone or nondiluted bleach.
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TMS60 Operator’s Manual 14 - 114 MaintenanceIntroduction...............................................................................................................14-2Safety............................................................................................................................14-2Regular Check ...........................................................................................................14-3Maintenance and Testing Schedule..................................................................14-4Checking the System Information.....................................................................14-4Verifying the ECG at the TD60.............................................................................14-4
Introduction Maintenance14 - 2 TMS60 Operator’s Manual14.1 IntroductionThe chapter outlines the routine telemetry devices maintenance guidelines.The telemetry devices are designed for stable operation over long periods of time.Under normal circumstances the devices should not require technical maintenancebeyond that described in this chapter. However, routine maintenance, calibration andsafety checks are recommended at least once a year or more often as required by localstatutory or hospital administration practice.14.2 SafetyWARNING•Failure on the part of the responsible individual hospital or institution employing the use of this equipment to implement a satisfactory maintenance schedule may cause undue equipment failure and possible health hazards.•The safety checks or maintenance involving any disassembly of the equipment should be performed by service personnel. Otherwise, undue equipment failure and possible health hazards could result.•No modification of this equipment is allowed.•To avoid the electric shock, do not open the central charger housing, otherwise . •All servicing and future upgrades must be carried out by the service personnel.•All replaced components and accessories as well as consumables are provided or qualified by Mindray.•If you discover a problem with any of the equipment, contact your service personnel or Mindray.•The service personnel must be properly qualified and thoroughly familiar with the equipment operation.
Maintenance Regular CheckTMS60 Operator’s Manual 14 - 314.3 Regular CheckPerform a visual inspection before the equipment is first used every day. Verify that theequipment meets the following requirements:■The housing and display screen are free from cracks or other damages.■All keys function properly.■Connectors are not loose, cracked, or bent and cables have no cuts, nicks, orfraying.■ECG leadwires are securely connected with the equipment.■Battery pack is installed and has sufficient charge.■Chest electrodes are free from cracks and limb electrodes can properly clamp.After your equipment has been used for 6 to 12 months, or whenever your equipment isrepaired or upgraded, a thorough inspection should be performed by qualified servicepersonnel to ensure the reliability.Follow these guidelines when inspecting the devices:■Make sure that the environment and power supply meet the requirements.■Inspect the devices and their accessories for mechanical damage.■Inspect all plugs, connectors, leadwires for damage, and make sure that theirinsulation is in good condition.■Make sure that only specified accessories are applied.■Make sure that the alarm system functions correctly.■Make sure that the battery meet the performance requirements.■Make sure that the devices are in good working condition.In case of any damage or abnormity, do not use the devices. Contact the hospital’s bio-medical engineers or your service personnel immediately.14.3.1 Power-on TestThe TD60 performs a self-test during startup. You can refer to "Powering On the Unit" onpage 3 - 8 for details. 14.3.2 Battery CheckFor details about the battery charge check and maintenance, refer to "Maintaining theRechargeable Lithium-ion Battery" on page 11 - 7.
Maintenance and Testing Schedule Maintenance14 - 4 TMS60 Operator’s Manual14.4 Maintenance and Testing ScheduleThe following maintenance and tests, except for visual inspection, power on test, andbattery check, shall be carried out by the service personnel only. Contact your servicepersonnel if any maintenance is required. Make sure to clean and disinfect the equip-ment before any test and maintenance.14.5 Checking the System InformationTo view the information about the device, radio frequency (RF), battery, MPAN, and sys-tem statistics, you can go to the main menu → [System Info].14.6 Verifying the ECG at the TD60The ECG signal may be inaccurate due to hardware or software problems. As a result, theECG wave amplitude becomes greater or smaller. To verify the ECG waveform amplitude: 1. In the main menu, tap [Maintenance].2. Input the maintenance passcode.3. Tap [Accept].4. In the [Maintenance] menu, tap [Others].5. Enable [Calibrate ECG].A square wave appears on the screen and the message [ECG Calibrating] is dis-played.Check/Maintenance Item Recommended FrequencyVisual inspection When first installed or reinstalled. ECG test and verification Performance test 1. If the user suspects that the measurement is incorrect.2. Following any repairs or replacement of rele-vant module.3. Once every two years.VerificationSpO2 testPower on test 1. When first installed or reinstalled.2. Following any maintenance or the replace-ment of any main unit parts.Battery check Functionality test 1. When first installed.2. Whenever the battery is replaced.Performance test When the battery run time reduced significantly.
Maintenance Verifying the ECG at the TD60TMS60 Operator’s Manual 14 - 56. Compare the amplitude of the square wave with the wave scale. The difference should be within 5%.7. After completing the verification, disable [Calibrate ECG].
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TMS60 Operator’s Manual 15 - 115 AccessoriesECG Accessories........................................................................................................15-2SpO2 Accessories.....................................................................................................15-3Miscellaneous............................................................................................................15-5
ECG Accessories Accessories15 - 2 TMS60 Operator’s ManualThe accessories listed in this chapter comply with the requirements of IEC 60601-1-2when in use with the device. The accessory material that contacts the patients hasundertaken the bio-compatibility test and is verified to be in compliance with ISO10993-1. For details about the accessories, refer to the instructions for use provided withthe accessory.15.1 ECG Accessories15.1.1 ECG ElectrodesWARNING•Use accessories specified in this chapter. Using other accessories may cause damage to the monitor or not meet the claimed specifications.•Single-use accessories are not designed to be reused. Reuse may cause a risk of contamination and affect the measurement accuracy.•Check the accessories and their packages for any sign of damage. Do not use them if any damage is detected.•Use the accessories before the expiry date if indicated.•The disposable accessories shall be disposed of according to the hospital's regulations.PN Description Applicable propertyApplicable patient0010-10-12304 Adult Electrode (Kendall, package of 10) Disposable Adult9000-10-07469 Pediatric ECG electrode (3M, package of 50) Disposable Pediatric
Accessories SpO2 AccessoriesTMS60 Operator’s Manual 15 - 315.1.2 ECG Leadsets3-Lead5-Lead15.2 SpO2 AccessoriesThe SpO2 sensor material that contacts patients or other staff has undertaken the bio-compatibility test and is verified to be in compliance with ISO 10993-1.15.2.1 Masimo SpO2 ModulePN Description Applicable propertyApplicable patient009-004765-00 3-Lead, New Telemetry, AHA, Snap, 24" Reusable Adult, Pediatric009-004766-00 3-Lead, New Telemetry, AHA, Snap, 36"009-004771-00 3-Lead, New Telemetry, AHA, Pinch, 24"009-004772-00 3-Lead, New Telemetry, AHA, Pinch, 36"009-004777-00 3-Lead, New Telemetry, Disp, AHA, Snap, 24" DisposablePN Description Applicable propertyApplicable patient009-004782-00 5-Lead, New Telemetry, AHA, Snap, 24" Reusable Adult, Pediatric009-004783-00 5-Lead, New Telemetry, AHA, Snap, 36"009-004786-00 5-Lead, New Telemetry, AHA, Pinch, 24"009-004787-00 5-Lead, New Telemetry, AHA, Pinch, 36"009-004790-00 5-Lead, New Telemetry, AHA, Snap, 24" DisposablePN Description Applicable propertyApplicable patient009-004936-00 Masimo SpO2 module (SET uSpO2) Reusable Adult, Pediatric
SpO2 Accessories Accessories15 - 4 TMS60 Operator’s Manual15.2.2 Masimo SpO2 SensorWavelength emitted by the sensors is between 600 nm and 1000 nm. The maximumphotic output consumption of the sensor is less than 18 mW.The information about the wavelength range and maximum photic output consump-tion can be especially useful to clinicians (for example, when photodynamic therapy isperformed). 15.2.3 Nonin SpO2 Module15.2.4 Nonin SpO2 SensorPN Description Applicable propertyApplicable patient0600-00-0121 LNCS Adtx-Adult Single Patient Adhesive Sen-sors, >30 kg (20/box)Disposable Adult0600-00-0122 LNCS Pdtx-Pediatric Single Patient Adhesive Sensors,10-50 kg (20/box)Pediatric0600-00-0126 LNCS DCI Adult Reusable Finger Sensor, >30 kg Reusable Adult0600-00-0127 LNCS DCIP Pediatric Reusable Finger Sensor, 10-50 kgPediatricPN Description Applicable propertyApplicable patient009-004935-00 Nonin SpO2 module (XPOD 3012LP) Reusable AdultPN Description Applicable property Applicable patient0600-00-0139-24 Nonin 7000AA SpO2 Sensor (box of 24)Disposable Adult100-000077-00 Nonin 8000AA SpO2 Sensor Reusable100-000134-00 Nonin 8000AP SpO2 Sensor Reusable Pediatric100-000135-00 Nonin 7000AP SpO2 Sensor (box of 24)Disposable
Accessories MiscellaneousTMS60 Operator’s Manual 15 - 515.3 MiscellaneousPN Description115-026852-00 Main unit of the charger022-000196-00 Telemetry Rechargeable battery045-001698-00 TP-2AA battery frame045-001699-00 TP-3AA battery frame0000-10-10902 Alkaline 1.5 V AA battery0146-00-0077-10 L91 AA battery048-005247-00 Disposable pouch048-005246-00 Reusable pouch
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TMS60 Operator’s Manual A - 1AProduct SpecificationsClassifications............................................................................................................A-2Environmental Specifications..............................................................................A-2Power Supply Specifications................................................................................A-3Physical Specifications ...........................................................................................A-4Hardware Specifications........................................................................................A-5Wireless Specification.............................................................................................A-7Mindray Patient Area Network (PAN) Specification.....................................A-9Measurement Specifications ...............................................................................A-10
Classifications Product SpecificationsA - 2 TMS60 Operator’s ManualA.1 ClassificationsThe Telemetry Monitoring System is classified, according to IEC60601-1:A.2 Environmental SpecificationsType of protection against electrical shockTD60: energized from an internal electrical power source.RC60: class I.Central Charger: class I.Degree of protection against electrical shock for the TD60Type CF defibrillation proof for ECG, and SpO2.Mode of operation ContinuousDegree of protection against harmful ingress of waterTD60: IPX7RC60: IPX0Central Charger: IPX0Degree of protection against hazards of explosionNot suitable: Equipment not suitable for use in the presence of a flammable anesthetic mixture with air with oxygen or nitrous oxide.Degree of protection against hazard of dropping for the TD60No damage by dropping from a height of 1.5 m.WARNING•The devices may not meet the performance specifications if stored or used outside the specified temperature and humidity ranges.Item Operating conditions Storage conditionsTemperature 0 °C to 37 °C -20 °C to 60 °CRelative humidity (noncondensing) 15% to 95% 10% to 95%Barometric 427.5 mmHg to 805.5 mmHg, or57.0 kPa to 107.4 kPa120 mmHg to 805.5 mmHg, or 16.0 kPa to 107.4 kPa
Product Specifications Power Supply SpecificationsTMS60 Operator’s Manual A - 3A.3 Power Supply SpecificationsA.3.1 TD60The TD60 is powered by batteries. A.3.2 RC60The telemetry receiver is powered by external AC power.Battery type AA batteries (two or three)Rechargeable lithium-ion battery (one)Capacity for lithium-ion battery≥ 3500 mAhSafety and authentication for lithium-ion batteryUL2054, IEC62133, UN38.3Run time for (at the temperature 25 °C ±5 °C, the screen display is off, no sound and light as default, no alarms, at least including 15 minutes operating time when the screen display is on, AA battery with PN 0146-00-0077-10 are used)Two AA batteriesThree AA batteriesLithium-ion battery5-lead ECG: ≥ 48 hours ≥ 72 hours ≥ 72 hours5-lead ECG + Nonin SpO2≥ 36 hours ≥ 48 hours ≥ 48 hours5-lead ECG + Masimo SpO2≥ 36 hours ≥ 48 hours ≥ 48 hoursPower On/OffThe startup logo displaying time is less than or equal to three seconds. The time for entering the main screen to display the waveforms is less than or equal to 15 seconds.Shutdown delay at least 15 minutes after the low battery alarm first occursat least five minutes after the critically low battery alarm first occursInput voltage 100 to 240 VAC (± 10%)Frequency 50 Hz/60 Hz (± 3 Hz)Input current 0.6 A to 0.3 A
Physical Specifications Product SpecificationsA - 4 TMS60 Operator’s ManualA.3.3 Central ChargerThe central charger is powered by external AC power.A.4 Physical SpecificationsA.4.1 TD60A.4.2 RC60A.4.3 Central ChargerInput voltage 100 VAC to 240 VAC (± 10%)Frequency 50 Hz/60 Hz (±3 Hz)Input current 1.5 A to 0.75 ACharge timeAt the room temperature: ≤ 5 hoursThe charge time definition: the time for the battery from the exhausted status to 90% battery charge (within the operating temperature range declared for the unit).Overcharge protection function The charger automatically stop charging when the lithium-ion battery charge is full.Size 125.8 mm × 63.7 mm × 23 mm (only for the transmitter, without the ECG leadwire, SpO2 module and any other accessories) Weight  210 g (with two AA batteries and 3-lead ECG cable, without the SpO2 module and any other accessories)Size 120 mm × 300 mm × 350 mmWeight  7000 gSize  365 mm × 170.6 mm × 77.9 mm (without batteries and wall-mount bracket)Weight  1130 g (without batteries and wall-mount bracket)
Product Specifications Hardware SpecificationsTMS60 Operator’s Manual A - 5A.5 Hardware SpecificationsA.5.1 TD60DisplayScreen type Color TFT LCD screenScreen size 3.5"Resolution 480 pixels × 320 pixelsDisplay Activation (Power On/Off) key The switch time is less than or equal to two seconds.LEDAlarm lamp 1 (three colors: red, yellow, and cyan)Audio IndicatorSpeaker 1Sound Pressure Range 45 dBA to 85 dBAKeysNurse call 1Power On/Off 1Main menu 1External ConnectorsECG connector 1SpO2 connector 1
Hardware Specifications Product SpecificationsA - 6 TMS60 Operator’s ManualA.5.2 RC60A.5.3 Central ChargerLEDCommunications indicator 1 (green), indicates the ready and communications status.Power indicator 1 (green), indicates the power status.Audio IndicatorBuzzer 1, indicates internal abnormity.External ConnectorsEthernet connector 1, standard RJ45 connectorAntenna connector 2Charger slot 10LED 10, which indicates the battery charge status.AC power indicator 1Installation mode Place on the desktop, or mount on GCX® wall channel.
Product Specifications Wireless SpecificationTMS60 Operator’s Manual A - 7A.6 Wireless SpecificationA.6.1 Technique SpecificationA.6.2 Implemented Functions The transmitter sends physiological data (such as ECG waveform and SpO2 parameter) and the transmitter status data (such as the status about lead, button, battery voltage, and others) to the receiver via the wireless network, and then the receiver sends those data to the central station (CS).The ECG data precision sent to the CS from the transmitter is 200 Hz, 8 bit per channel.The transmitter automatically networks with the CS after the transmitter is turned on. The time from the boot to connecting with the CS network is less than or equal to 15 seconds.The receiver can detect the wireless signal strength of the transmitter, and send the information to the CS.Protocol standard Private protocolDebugging mode GFSKWork frequency 608 MHz to 614 MHzChannel interval 25 KHzWireless baud rate 8 kbps ± 3%Output power < 10 mWReceiving sensitivity ≤-110 dBm (≤ 1% error code rate)Data security Private protocol
Wireless Specification Product SpecificationsA - 8 TMS60 Operator’s ManualA.6.3 Function SpecificationWARNING•Do perform all network functions of data communication within an enclosed network.Data integrity Code error ≤ 1%Data latency Total delay of data transmission from the transmitter to the CS: ≤ 3 secondsPriority All communication data type have the same priority.Transmission distance Distinct vision distance between the transmitter and the receiver antenna is greater than or equal to 50 m.Receiver capacity 16 bedsSystem capacity 32 bedsDynamic networking stabilityThe wireless functions of the test transmitter are normal while the transmitter is moving at the rate of no more than 3.75 m/s within the wireless transmission distance.Resistance to wireless interferenceWhen the distance between the wireless device at the frequency of 2.4 GHz (including cellular mobile communication networks, microwave ovens, cordless phones, and other devices) and the receiver antenna is one meter, and the receiver antenna exists a WMTS interference at the same frequency of -118 dBm, the wireless functions are normal.Communication interruption alarmAfter the communication between the transmitter and the receiver is interrupted, the CS displays the alarm information within five seconds.Signal strength detection RSSI detection scope: -110 dBm to -80 dBm
Product Specifications Mindray Patient Area Network (PAN) SpecificationTMS60 Operator’s Manual A - 9A.7 Mindray Patient Area Network (PAN) SpecificationA.7.1 Technique SpecificationA.7.2 Implemented FunctionThe function implemented by the Mindray PAN is transferring the configuration between the transmitters.A.7.3 Function SpecificationProtocol standard Mindray PAN low energy 4.0Debugging mode GFSKWork frequency 2400 MHz to 2483.5 MHzChannel interval 2 MHzWireless baud rate 1 MbpsOutput power ≤ 1 mWData Security 128 bit AESData integrity Code error ≤ 1%Data latency Total delay of data transmission between the transmitters: ≤ 1 secondPriority All communication data type shall have the same priority.Transmission distance Distinct vision distance between the transmitters is greater than or equal to 3 m.System capacity 10 m2 space can hold 10 transmitters at the same time.Resistance to wireless interferenceWhen the distance between the wireless device at the frequency of 2.4 GHz (including cellular mobile communication networks, microwave ovens, cordless phones, and other devices) and the transmitter is one meter, the Mindray PAN communication functions are normal.Communication interruption alarmAfter the Mindray PAN communication between the transmitters is interrupted, the transmitter prompts that the communication is failed.
Measurement Specifications Product SpecificationsA - 10 TMS60 Operator’s ManualA.8 Measurement SpecificationsA.8.1 ECGECGStandard Meet standards of IEC60601-2-27 and IEC60601-2-25Leadset3-lead: I, II, III5-lead: I, II, III, aVR, aVL, aVF, VAutomatic 3/5 lead recognitionECG standard AHA, IECSweep speed 6.25 mm/s, 12.5 mm/s, 25 mm/sAccuracy: ± 10%Display Sensitivity1.25 mm/mV (×0.125), 2.5 mm/mV (×0.25), 5 mm/mV (×0.5), 10 mm/mV (×1), 20 mm/mV (×2), 40 mm/mV (×4) Accuracy: ± 5%Input signal range ±8 mV (peak-to-peak value)Calibration signal 1 mV (peak-to-peak value)Accuracy: ± 5%Differential input impedance ≥ 5 MBandwidth (-3dB) Monitor mode: 0.5 Hz to 40 HzST mode: 0.05 Hz to 40 HzCommon mode rejection ratio(with Notch off)Monitor mode: > 105 dBST mode: > 105 dBNotch 50/60 Hz, rejection capacity ≥ 20 dBPolarizing voltage scope ± 500 mVNoise ≤ 30 µV (p-v RTI)Baseline recovery time < 5 s (after defibrillation)Direct current leakage  Input electrode: < 0. 1µADrive electrode: <1µAElectrode polarization recovery time < 10 s
Product Specifications Measurement SpecificationsTMS60 Operator’s Manual A - 11Defibrillation energy absorption ≤ 10% (100  load)Pace PulsePace pulse markersPace pulses meeting the following conditions are labelled with a PACE marker:Amplitude: ±2 mV to ±700 mVWidth: 0.1 ms to 2 msRise time: 10 s to 100 sAmplitude: ≥ 0.2mV RTIPace pulse rejectionWhen tested in accordance with the IEC60601-2-27: 201.12.1.101.13, the heart rate meter rejects all pulses meeting the following conditions.Amplitude: ±2 mV to ±700 mVWidth: 0.1 ms to 2 msRise time: 10 s to 100 sAbout 50% pulse of ANSI/AAMI EC13 (5d) can trigger the pulse detector, the least changing rate is 20 V/s RTI.HRMeasurement range Adult: 0, 15 bpm to 300 bpmPediatric: 15 bpm to 350 bpmResolution 1 bpmAccuracy ± 1 bpm or ± 1%, whichever is greater.SensitivityMindray ECG algorithm Mortara ECG algorithm200 V 160 V to 480 V
Measurement Specifications Product SpecificationsA - 12 TMS60 Operator’s ManualHR averaging methodMindray ECG algorithm Mortara ECG algorithmIn compliance with the requirements in Clause 201.7.9.2.9.101 b) 3) of IEC60601-2-27, the following method is used:If the last 3 consecutive RR intervals are greater than 1200 ms, the 4 most recent RR intervals are averaged to compute the HR. Otherwise, heart rate iscomputed by subtracting the maximum and minimum ones from the most recent 12 RR intervals and then averaging them.The HR value displayed on the monitor screen is updated every second.In compliance with the requirements in Clause 201.7.9.2.9.101 b) 3) of IEC60601-2-27, the following method is used:Heart rate is computed by averaging the most recent 16 RR intervals, unless the HR by averaging the most recent 4 heart beats is less than or equal to 48 bpm.The HR value displayed on the monitor screen is updated every second.Tall T-wave rejection capabilityWhen the test is performed based on Clause 201.7.9.2.9.101 b) 2)of IEC60601-2-27, the heart rate meter will reject all 100 ms QRS complexes with less than 1.2 mV of amplitude, and T waves with T-wave interval of 180 ms and those with Q-T interval of 350 ms.Response time to heart rate changeMeets the requirements of IEC60601-2-27: Clause 201.7.9.2.9.101 b) 5).From 80 bpm to 120 bpm: less than 11 sFrom 80 bpm to 40 bpm: less than 11 sResponse to irregular rhythmIn compliance with the requirements in Clause 201.7.9.2.9.101 b) 4) of IEC60601-2-27, the heart rate after 20 seconds of stabilization is displayed as follows:Ventricular bigeminy (3a): 80 ± 1 bpmSlow alternating ventricular bigeminy (3b): 60 ± 1 bpmRapid alternating ventricular bigeminy (3c): 120 ± 1 bpmBidirectional systoles (3d): 90 ± 2 bpmTime to alarm for tachycardiaMeets the requirements of IEC60601-2-27: Clause 201.7.9.2.9.101 b) 6). Waveform4ah - range: < 11 s4a - range: < 11 s4ad - range: < 11 s4bh - range: < 11 s4b - range: < 11 s4bd - range: < 11 sST Segment AnalysisMeasurement range -2.0 mV to +2.0 mV RTI
Product Specifications Measurement SpecificationsTMS60 Operator’s Manual A - 13Resolution 0.01 mVAccuracy -0.8 mV to +0.8 mV: ± 0.02 mV or ± 10%, whichever is greaterBeyond this range: Not specifiedArrhythmia AnalysisArrhythmia analysis classificationsMindray ECG algorithm Mortara ECG algorithmAsystole, VFib/VTac, Vtac, Vent. Brady, Extreme Tachy, Extreme Brady, PVCs/min, Pauses/min, R on T, Run PVCs, Couplet, Multif. PVC, PVC, Bigeminy, Trigeminy, Tachy, Brady, Pacer Not Pacing, Pacer Not Capture, Missed Beat, Nonsus. Vtac, Vent. Rhythm, Pause, Irr.Rhythm, AfibAsystole, VFib, Vtac, Extreme Tachy, Extreme Brady, PVCs/min, Pauses/min, R on T, Run PVCs, Couplet, Multif. PVC, Bigeminy, Trigeminy, Tachy, Brady, Pacer Not Pacing, Pacer Not Capture, Vent. Rhythm, Pause, Irr.RhythmQT AnalysisQTc formula Bazett, Fridericia, Framingham, and HodgesMindray ECG algorithm Mortara ECG algorithmQT measurement range [200, 800] ms [300, 600] msQT accuracy[200, 800] ms: ± 30 msBeyond this range: Not specified[300, 600] ms: ± 30 msBeyond this range: Not specifiedQT resolution[200, 800] ms: 4 msBeyond this range: Not specified[300, 600] ms: 2 msBeyond this range: Not specifiedQTc measurement range [200, 800] ms [300, 600] msQTc resolution[200, 800] ms: 1 msBeyond this range: Not specified[300, 600] ms: 1 msBeyond this range: Not specifiedQT-HR measurement range Adult: [15, 150] bpmPediatric: [15, 180] bpmN/A
Measurement Specifications Product SpecificationsA - 14 TMS60 Operator’s ManualA.8.2 SpO2A.8.2.1 Nonin SpO2 ModuleNOTE•A functional tester or SpO2 simulator can be used to determine the pulse rate accuracy.SpO2Measurement range 0% to 100%Resolution 1%Accuracy 70-100%: ±3 digits0-69%: Not specifiedData update rate ≤2s*Studies were performed to validate the accuracy of Pulse Oximeter with Nonin SpO2 sensors by contrast with a CO-Oximeter. In total, 12 adults (7 male & 5 female) aged from 19 to 35 years old were voluntarily involved in this study. Five are Caucasian, two are Indian, three are Asian, and two are African-American. All of them conform the clinical study requirements for age, gender, skin and health.The following table shows the accuracy (Arms) for the SpO2 sensors in four kinds of SaO2 ranges. For the Fitting Curve of the SpO2 sensors, refer to the "Fitting Curve for Nonin SpO2 Sensors" on page A - 15.SaO2 range Measured Arms Value (7000A, 7000P, 8000AA, 8000AP)70% to 100% 1.5470% to 80% 1.4180% to 90% 1.9790% to 100% 1.28PRMeasurement range 20 bpm to 300 pmResolution 1 bpm
Product Specifications Measurement SpecificationsTMS60 Operator’s Manual A - 15A.8.2.2 Fitting Curve for Nonin SpO2 Sensors  7000A, 7000P, 8000AA, 8000APSpO2 = 1.01 × SaO2 – 2.6Scatter Plot of the SpO2 versus the SaO2Accuracy ±3 bpmResponse Time■≤ 25 s (PR 75 bpm, average time 4 heart beats, no disturbance, SpO2 value rises from 70% to100%)■≤ 35 s (SpO2 value 98%, average time 4 heart beats, no disturbance, PR value rises from 60bpm to 150 bpm)
Measurement Specifications Product SpecificationsA - 16 TMS60 Operator’s ManualBland-Altman Plots of the Bias versus the MeanA.8.2.3 Masimo SpO2 ModuleSpO2Measurement range 1% to 100%Resolution 1%Accuracy70 to 100%: ±2% (measured without motion in adult/pediatric mode)70 to 100%: ±3% (measured with motion)1% to 69%: Not specified.Low Perfusion Conditions Pulse amplitude: > 0.02%Light penetration: > 5%Low Perfusion Accuracy 2%*SpO2 accuracy was determined by testing on healthy adult volunteers in the range of 60% to 100% SpO2 against a laboratory CO-Oximeter. SpO2 accuracy was determined on 16 neonatal NICU patients ranging in age from 7-135 days old and weighing between 0.5-4.25 kg. Seventy-nine (79) data samples were collected over range of 70-100% SaO2 with a resultant accuracy of 2.9% SpO2.The following table shows the accuracy (Arms) for the SpO2 sensors in four kinds of SaO2 ranges. For the Fitting Curve of the SpO2 sensors, refer to the "Fitting Curve for Masimo SpO2 Sensors" on page A - 18.
Product Specifications Measurement SpecificationsTMS60 Operator’s Manual A - 17SaO2 rangeMeasured Arms ValuesLNCS Adtx, LNCS Pdtx LNCS DCI, LNCS DCIP70% to 100% ± 2% 2%70% to 80% 1.55% 0.60%80% to 90% 1.07% 0.54%90% to 100% 1.64% 0.60%PRMeasurement range 25 bpm to 240 bpmResolution 1 bpmAccuracy  ± 3 bpm (without motion)± 5 bpm (with motion)Response Time≤ 25 s (PR 75 bpm, average time 8 s, no disturbance, SpO2 value rises from 50% to 100%)≤ 20 s (SpO2 value 98%, average time 8 s, no disturbance, PR value rises from 60 bpm to 150 bpm)PIMeasurement range 0.02% to 20%Least resolution 0.01, use three valid digitsResponse Time■≤ 25 s (PR 75 bpm, average time 8 s, no disturbance, SpO2 value rises from 50% to 100%)■≤ 20 s (SpO2 value 98%, average time 8 s, no disturbance, PR value rises from 60 bpm to 150bpm)
Measurement Specifications Product SpecificationsA - 18 TMS60 Operator’s ManualA.8.2.4 Fitting Curve for Masimo SpO2 Sensors
TMS60 Operator’s Manual B - 1BEMC
EMCB - 2 TMS60 Operator’s ManualThe telemetry monitoring system (TMS) meets the requirements of IEC 60601-1-2.WARNING•Use of accessories and cables other than those specified may result in increased emission and/or decreased immunity of the system.•Devices too close or stacked may interfere with each other. Do not put devices too close or stack them together. Keep a close eye on the system in case there are other devices around it.•Neighboring frequencies of transmitters too close may interfere with each other, and the CS cannot receive data or receive erroneous data. Therefore it is recommended that the interval of neighboring frequencies is not smaller than 25kHz.•Devices even in compliance with CISPR transmitting requirements may interfere with the system.•If the input signal is lower than the specified threshold, measurements may be inaccurate.•Other equipment that have RF transmit or source may affect this device (for example, cell phones, PDAs, PCs with wireless function).Guidance and declaration — electromagnetic emissionsThe system is intended for use in the electromagnetic environment specified below.The user of the system should assure that it is used in such an environment. Emissions test Compliance Electromagnetic environment — guidanceRF emissionsCISPR 11Group 1 The system uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.RF emissionsCISPR 11Class A The system is suitable for use in all establishments other than domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.HarmonicEmissions IEC61000-3-2Class AVoltage Fluctuations/Flicker Emissions IEC 61000-3-3Compliance
EMCTMS60 Operator’s Manual B - 3Guidance and declaration — electromagnetic immunityThe system is intended for use in the electromagnetic environment specified below.The user of the system should assure that it is used in such an environment.Immunity test IEC 60601 Test levelCompliance level Electromagnetic environment - guidanceElectrostaticDischarge (ESD)IEC 61000-4-2± 6 kV contact± 8 kV airFloors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.Electrical fast Transient/burst IEC 61000-4-4± 2 kV for power cord± 1 kV for I/O cablesMains power quality should be that of a typical commercial or hospital environment.Surge IEC61000-4-5± 1 kV different mode± 2 kV common modeVoltage dips,Short interruptions and voltage variation on power supply input lines IEC 61000-4-11<5% UT (>95% dip in UT) for 0.5 cycle40% UT (60% dip in UT) for 5 cycle70% UT (30% dip in UT) for 25 cycle<5% UT (>95% dip in UT) for 5 secMains power quality should be that of a typical commercial or hospital environment. If the user of our product requires continued operation during power mains interruptions, it is recommended that our product be powered from an uninterruptable power supply or a battery. Power frequency(50/60 Hz) magnetic field IEC 61000-4-83 A/m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.Note: UT is the A.C. mains voltage prior to application of the test level.
EMCB - 4 TMS60 Operator’s ManualGuidance and declaration — electromagnetic immunityThe system is intended for use in the electromagnetic environment specified below.The customer or the user of the system should assure that it is used in such an environment.Immunity test IEC 60601 Test levelCompliance level Electromagnetic environment - guidanceConduced RF IEC 61000-4-63 Vrms 150kHz to 80MHz3 Vrms Portable and mobile RF communications equipment should be used no closer to any part of the system, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.Recommended separation distanced = 1.2d = 1.2  80 M to 800 MHzd = 2.3  800 M to 2.5 GHzwhere P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m).Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey a, should be less than the compliance level in each frequency range b.Interference may occur in the vicinity of equipment marked with the following symbol:Radiated RF IEC 61000-4-33 V/m 80MHz to 2.5GHz3 V/mNote: At 80 MHz and 800 MHz, the higher frequency range applies.Note: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.Note: The TMS that intentionally receives RF electromagnetic energy at the exclusion band (2395.825MHz-2487.645MHz) is exempt from the ESSENTIAL PERFORMANCE requirements, but remains safe.a: Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the system is used exceeds the applicable RF compliance level above, the system should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the system.b: Over the frequency ranges 150kHz to 80MHz, field strengths should be less than 3V/m.PPP
EMCTMS60 Operator’s Manual B - 5If the system is operated within the electromagnetic environment listed in Table Guid-ance and declaration — electromagnetic immunity, the system will remain safe andprovide the following essential performance:■Operating mode■Accuracy■Function■Accessories identification■Data stored■Alarm■Detect for connectionRecommended separation distances between portable and mobile RF communication and the systemThe system is intended for use in an electromagnetic environment in which radiated RF disturbance are controlled. The customer or the user of the system can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communication equipment (transmitters) and the system as recommended below, according to the maximum output power of the communication equipment.Rated Maximum Output power of Transmitter W (Watts)Separation Distance According to Frequency of Transmitter M (Meters)150kHz -80MHzd = 80MHz to 800MHzd = 800MHz to 2.5GHzd = 0.01 0.12 0.12 0.230.1 0.37 0.37 0.741 1.17 1.17 2.3410 3.69 3.69 7.38100 11.67 11.67 23.34For transmitters at a maximum output power not listed above, the recommended separation distanced in meters (m) can be determined using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.Note: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.Note: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.3.53---------P3.53---------P73---P
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TMS60 Operator’s Manual C - 1CFCC ComplianceThe telemetry monitoring system (TMS) complies with the requirements of FCC Part 95:Authorized health care providers, in conjunction with the equipment manufacturers,must cooperate in the selection and use of frequencies in order to reduce the potentialfor interference with other wireless medical telemetry devices, or other co-primary users.Operations in the 608–614 MHz band (television channel 37) are not protected fromadjacent band interference from broadcast television operating on channels 36 and 38.As the RF range of the system is 608-614Mhz, if located near the radio astronomy obser-vatories the two parties will interfere with each other.Therefore, we don't suggest that the equipment can be installed or operated within 80kilometers of:1. National Astronomy and Ionosphere Center, Arecibo, Puerto Rico: 18°20′38.28″ North Latitude, 66°45′09.42″ West Longitude.2. National Radio Astronomy Observatory, Socorro, New Mexico: 34°04′43″ North Lat-itude, 107°37′04″ West Longitude.3. National Radio Astronomy Observatory, Green Bank, West Virginia: 38°26′08″ North Latitude, 79°49′42″ West Longitude.This device and its antenna must not be located or operating in conjunction with anyother antenna and transmitter.This device complies with part 15 of the FCC rules. Operation is subject to the followingtwo conditions: (1) this device may not cause harmful interference, and (2) this devicemust accept any interference received, including interference that may cause undesiredoperation.Changes or modifications not expressly approved by the party responsible for compli-ance could void the user’s authority to operate the equipment.
FCCComplianceTMS60Operator’sManualC‐3NOTE● ThisequipmenthasbeentestedandfoundtocomplywiththelimitsforaClassBdigitaldevice,pursuanttopart15oftheFCCRules.Theselimitsaredesignedtoprovidereasonableprotectionagainstharmfulinterferenceinaresidentialinstallation.Thisequipmentgeneratesusesandcanradiateradiofrequencyenergyand,ifnotinstalledandusedinaccordancewiththeinstructions,maycauseharmfulinterferencetoradiocommunications.However,thereisnoguaranteethatinterferencewillnotoccurinaparticularinstallation.Ifthisequipmentdoescauseharmfulinterferencetoradioortelevisionreception,whichcanbedeterminedbyturningtheequipmentoffandon,theuserisencouragedtotrytocorrecttheinterferencebyoneormoreofthefollowingmeasures:Reorientorrelocatethereceivingantenna.Increasetheseparationbetweentheequipmentandreceiver.Connecttheequipmentintoanoutletonacircuitdifferentfromthattowhichthereceiverisconnected.RadioFrequencyExposureThisequipmentcomplieswithFCCradiationexposurelimitssetforthforanuncontrolledenvironment.Thistransmittermustnotbeco‐locatedoroperatinginconjunctionwithanyotherantennaortransmitter.OperationofthisequipmentrequiresthepriorcoordinationwithafrequencycoordinatordesignatedbytheFCCfortheWirelessMedicalTe le metry Service.RadiofrequencyRadiationExposureInformationForbodywornoperation,thisequipmenthasbeentestedandmeetstheFCCandCERFexposureguidelineswhenusedwiththeaccessoriessuppliedorthoseapprovedforusewiththisproduct.UseofotheraccessoriesmaynotensurecompliancewithFCCandCERFexposureguidelineswithin32kilometersoftheNationalRadioAstronomyObservatorycenteredon:
FCCComplianceTMS60Operator’sManualC‐3VerylongbaselinearraystationsLatitude(north)Longitude(west)PieTown,NM34°18′108°07′KittPeak,AZ31°57′111°37′LosAlamos,NM35°47′106°15′FortDavis,TX30°38′103°57′NorthLiberty,IA41°46′91°34′Brewster,WA48°08′119°41′OwensValley,CA37°14′118°17′SaintCroix,VI17°46′64°35′MaunaKea,HI19°49′155°28′Hancock,NH42°56′71°59′Iftheinstallationdistanceisnotenough,obtainthewrittenconcurrenceoftheDirectoroftheaffectedradioastronomystationbeforetheequipmentcanbeinstalledoroperated.RFParameters
FCC ComplianceC - 4 TMS60 Operator’s ManualItem ParameterOperating Frequency Band (MHz) 608 to 614Modulation GFSKTransmitter Output Power(e.i.r.p) (dBm) < 10Channel Space (KHz) 25
TMS60 Operator’s Manual D - 1DSymbols and AbbreviationsUnits..............................................................................................................................D-2Symbols.......................................................................................................................D-3Abbreviations............................................................................................................D-3
Units Symbols and AbbreviationsD - 2 TMS60 Operator’s ManualD.1 UnitsAampereAh ampere hourbpm beats per minute°C centigradecc cubic centimetercm centimeterdB decibelDS dyne. second°F fahrenheitggramhr hourhPa hundred pascalHz hertzin inchkkilokg kilogramkPa kilopascalllitrelb poundmmetermg milligramsmin minuteml millilitermm millimetersms millisecondmV millivoltmW milliwattnm nanometerppm part per millionssecondVvoltVA volt ampereohmA microamperem micron
Symbols and Abbreviations SymbolsTMS60 Operator’s Manual D - 3D.2 SymbolsD.3 AbbreviationsV microvoltWwatt-minus%percent/ per; divide; or^power+plus=equal to<less than> greater than≤ less than or equal to≥ greater than or equal to±plus or minus× multiply©copyrightAAMI Association for Advancement of Medical InstrumentationAC alternating currentAHA American Heart AssociationANSI American National Standard InstituteARR arrhythmiaART arterialAUX Auxiliary outputaVF left foot augmented leadaVL left arm augmented leadaVR right arm augmented leadCH channelCISPR International Special Committee on Radio InterferenceCS central stationECG electrocardiographEMC electromagnetic compatibility
Abbreviations Symbols and AbbreviationsD - 4 TMS60 Operator’s Manualerr errorES electrosurgicalESU electrosurgical unitHR heart rateHT heightIEC International Electrotechnical CommissionISO  International organization for standardizationMRI magnetic resonance imagingLA(L) left armLAP left atria pressureLED light emitting diodeLL(F) left legLoop loop read-write test failM, MEAN mean pressureO2 oxygenPpowerPAN Patient Area NetworkPR pulse rateQRS interval of ventricular depolarization(QRS complex) RA(R) right armRL(N) right legROM read-only memorySpO2arterial oxygen saturation from pulse oximetryVGA Video Graphics Array
TMS60 Operator’s Manual E - 1EAnomalyE.1 Anomaly DescriptionThis product does not have any anomalies.
Anomaly Description AnomalyE - 2 TMS60 Operator’s ManualThis page intentionally left blank.
P/N: 046-007056-00 (1.0)

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