Mindray BeneVision TMS60 Operator's Manual

Telemetry monitoring system

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Service manual (104 pages)

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BeneVision TMS60

Telemetry Monitoring System

Operator's Manual

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Page 1 BeneVision TMS60 Telemetry Monitoring System Operator’s Manual...
Page 4 Manufacturer’s Responsibility Contents of this manual are subject to changes without prior notice. All information contained in this manual is believed to be correct. Mindray shall not be liable for errors contained herein nor for incidental or consequential damages in connection with the furnishing, performance, or use of this manual.
Page 5 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...
Page 6 Introduction Exemptions Mindray's obligation or liability under this warranty does not include any transportation or other charges or liability for direct, indirect or consequential damages or delay resulting from the improper use or application of the product or the use of parts or accessories not approved by Mindray or repairs by people other than Mindray authorized personnel.
Page 7 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.
Page 8 Preface Introduction This page intentionally left blank. TMS60 Operator’s Manual...
Page 9: Table Of Contents
Contents 1 Safety ............................1 - 1 1.1 Safety Information ............................. 1 - 2 1.1.1 Warnings ............................1 - 3 1.1.2 Cautions ............................1 - 4 1.1.3 Notes ..............................1 - 5 1.2 Equipment Symbols ..........................1 - 5 2 General Product Description ....................2 - 1 2.1 Intended Use ..............................
Page 10 3.7.10 Acknowledging the Nurse Call ..................3 - 13 3.8 Using the Pouch ............................3 - 14 3.8.1 Securing the Pouch ........................3 - 14 4 User Configurations ......................... 4 - 1 4.1 Introduction ..............................4 - 2 4.2 Configuring the Display ........................... 4 - 2 4.2.1 Setting the Default Display Orientation ................
Page 11 7.3.3 Setting ECG Lead Labeling ...................... 7 - 5 7.3.4 Placing the Electrodes ....................... 7 - 5 7.3.5 Checking the Lead Placement ....................7 - 9 7.3.6 Checking the Paced Status ....................7 - 10 7.4 Changing the ECG Settings ........................7 - 11 7.4.1 Configuring the ECG Setup ....................7 - 11 7.4.2 ECG Leadwire Types .........................7 - 12 7.4.3 Configuring the ECG Waveforms ..................7 - 12...
Page 12 9.4 QT Monitoring ............................9 - 18 9.4.1 Measurement Limitations ......................9 - 18 9.4.2 QT Settings ..........................9 - 18 9.4.3 QT View Menu (Only for Mindray ECG Algorithm) ............9 - 20 9.4.4 QT Display ............................9 - 21 9.5 ST Monitoring ............................9 - 22 9.5.1 Measurement Limitations ......................9 - 23...
Page 13 11.5 Removing the Battery ...........................11 - 4 11.6 Charging the Rechargeable Lithium-ion Battery ................11 - 5 11.7 Storing the Batteries ..........................11 - 6 11.7.1 Storing Rechargeable Lithium-ion Battery ..............11 - 6 11.7.2 Storing AA Batteries .......................11 - 6 11.8 Maintaining the Rechargeable Lithium-ion Battery ..............11 - 7 11.9 Disposing of the Batteries ........................11 - 8 11.9.1 Disposing of the Rechargeable Lithium-ion Battery ..........11 - 8 11.9.2 Disposing of the AA Batteries ....................11 - 8...
Page 14 A.6.1 Technical Specification ......................A - 7 A.6.2 Implemented Functions ......................A - 7 A.6.3 Performance Specification ......................A - 8 A.7 Mindray Patient Area Network (MPAN) Specification ..............A - 9 A.7.1 Technical Specification ......................A - 9 A.7.2 Implemented Function ......................A - 9 A.7.3 Performance Specification ......................A - 9...
Page 15: Safety
Safety Safety Information....................1-2 Equipment Symbols....................1-5 TMS60 Operator’s Manual 1 - 1...
Page 16: Safety Information
Safety Information Safety Safety Information WARNING • 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 •...
Page 17: Warnings
Safety Safety Information 1.1.1 Warnings WARNING • 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.
Page 18: Cautions
Safety Information Safety WARNING • 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. •...
Page 19: Notes
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.
Page 20 Equipment Symbols Safety Symbol Description Symbol Description Date of Manufacture Symbol for “MANUFAC- TURER” MR Unsafe – do not sub- Protection against fluid IPX7 ject to magnetic reso- ingress nance imaging (MRI) Interference may occur General warning sign in the vicinity of equip- ment marked with this symbol Refer to instruction manual/booklet...
Page 21: General Product Description
General Product Description Intended Use ......................2-2 Applied Parts ......................2-2 Key Features.......................2-2 System Components ....................2-3 TD60 Physical View....................2-3 Antenna Array ......................2-5 Telemetry Receiver (RC60)..................2-5 Touch Screen Display....................2-5 TMS60 Operator’s Manual 2 - 1...
Page 22: Intended Use
Intended Use General Product Description Intended Use The TMS60 transmitter is intended for use on Adult and Pediatric patients to monitor ECG and SpO physiological data. The physiological data can be reviewed locally on the display of the transmitter. The CentralStation will support ECG, Heart Rate, SpO , Pulse Rate, Arrhythmia analysis, QT monitoring, and ST Segment Analysis for the TMS60.
Page 23: System Components
General Product Description System Components ■ Display supports Parameter auto-sizing. System Components The telemetry monitoring system (TMS60) includes the following components: ■ Telemetry transmitter (TD60) ■ Telemetry antenna array ■ Telemetry receiver (RC60) TD60 Physical View Display Activation (Power On/Off ) key When the TD60 is powered off ◆...
Page 24 TD60 Physical View General Product Description Nurse Call key Pressing 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. Main Menu key ◆...
Page 25: Antenna Array
General Product Description Antenna Array Antenna Array The antenna array must be installed and configured by Mindray authorized personnel. For more details about the antenna array installation, calibration, and validation, refer to the Telemetry Monitoring System Installation Guide (P/N 046-007624-00).
Page 26: Display Screen
Touch Screen Display General Product Description 2.8.1 Display Screen The main screen displays patient parameters and waveforms. A typical display screen is shown below. Patient information area This area shows the patient information such as patient category, device name, and department. Tapping this area displays the Patient Info menu. Alarm symbols ◆...
Page 27: On-Screen Keyboard
General Product Description Touch Screen Display 2.8.2 On-Screen Keyboard The TD60 uses an on-screen keyboard to enter alphanumeric information, such as the device name and passwords. 2.8.2.1 Alphabetic Keyboard Alphabetic buttons: tap to input the desired alphabetic text. Delete button: tap to erase the text to the left of the cursor. Accept button: tap to save the settings and exit the keyboard.
Page 28 Touch Screen Display General Product Description More punctuation buttons: tap to display the punctuation keyboard, as shown below. 2 - 8 TMS60 Operator’s Manual...
Page 29: Getting Started
Getting Started Unpacking and Checking..................3-2 Environmental Requirements ................3-3 Connecting the ECG Leadwire ................3-4 Installing the Batteries ...................3-5 Powering On the Unit.....................3-8 Understanding Touch Gestures ................3-9 Basic Operations.......................3-9 Using the Pouch .......................3-14 TMS60 Operator’s Manual 3 - 1...
Page 30: Unpacking And Checking
• 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.
Page 31: Environmental Requirements
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. TMS60 Operator’s Manual 3 - 3...
Page 32: Connecting The Ecg Leadwire
Connecting the ECG Leadwire Getting Started Connecting the ECG Leadwire Align the ECG leadwire plug with the ECG connector as indicated by the arrow in the following figure. Insert the ECG leadwire plug into the ECG connector as shown in the enlarged fig- ure below.
Page 33: Installing The Batteries
Getting Started Installing the Batteries 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.
Page 34: Installing The Lithium-Ion Rechargeable Battery
Installing the Batteries Getting Started 3.4.1 Installing the Lithium-ion Rechargeable Battery 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 performance NOTE •...
Page 35: Installing The Aa Batteries
Getting Started Installing the Batteries 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 Batteries There are two types of AA battery trays, which are used for holding AA batteries: ■...
Page 36: Powering On The Unit
Powering On the Unit Getting Started 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. Press down the battery tray until it closes firmly, as indicated by the arrow in the following figure.
Page 37: Understanding Touch Gestures
Contact your service personnel or Mindray. Understanding Touch Gestures Before using the TD60, understand the supported touch screen gestures:...
Page 38: Understanding The Screen Display Orientation
Basic Operations Getting Started 3.7.1 Understanding the Screen Display Orientation The TD60 supports both the portrait and landscape display orientations. Example of landscape display Example of portrait display ■ Portrait: both digital and waveform tiles take up the entire width of the screen. ■...
Page 39: Displaying The Quick Keys Area
Getting Started Basic Operations 3.7.5 Displaying the Quick Keys Area Swipe 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: Quick keys Description Discharge Patient Tap the button to enter the Discharge Patient menu.
Page 40: Turning The Display Off
Basic Operations Getting Started All menus contain the following parts: Heading: displays the current menu title. Scroll bar: indicates the current scroll position within the menu. Main body: contains menus, buttons, and other controls to configure and operate the device. Controls Description Accesses a submenu to reveal more options or information.
Page 41: Turning The Display On
Getting Started Basic Operations 3.7.8 Turning the Display On If the screen is off, press the key to turn the display on. CAUTION • Do not let the display directly touch the patient when the display is on. 3.7.9 Unlocking the Screen If you set the screen lock, you need to input the correct passcode to unlock the screen after the display turns off.
Page 42: Using The Pouch
Using the Pouch Getting Started WARNING • Do not only rely on the nurse call function, the medical personnel should also pay close attention to the patient’s condition. Using the Pouch The 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.
Page 43 Getting Started Using the Pouch Wearing the reusable pouch Wearing the disposable pouch WARNING • 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.
Page 44 Using the Pouch Getting Started This page intentionally left blank. 3 - 16 TMS60 Operator’s Manual...
Page 45: User Configurations
User Configurations Introduction.......................4-2 Configuring the Display..................4-2 Configuring the Audio Volume................4-5 TMS60 Operator’s Manual 4 - 1...
Page 46: Introduction
Introduction User Configurations Introduction This chapter describes the configurations available for users to do, such as configuring the Display Setup, and Audio Volume. Configuring the Display You can configure the display by setting the display layout, display orientation, and screen brightness. In the main menu, tap Display Setup to enter the Display Setup menu.
Page 47: Understanding Landscape Orientation Display Rules
User Configurations Configuring the Display 4.2.4 Understanding Landscape Orientation Display Rules In landscape orientation, waveform areas take up the entire width of the screen. Digital areas only take up one half of the width of the screen. The following rules define how the tiles will be laid out: 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.
Page 48: Setting The Landscape Display
Configuring the Display User Configurations 4.2.5 Setting the Landscape Display In the Landscape section of the Display Setup menu, tap Rows. Three options display: 2, 3, and 4. Tap an option to set the row numbers. The selected option displays to the right of Rows. Tap Landscape Order to enter the Landscape Order menu.
Page 49: Configuring The Audio Volume
User Configurations Configuring the Audio Volume Configuring the Audio Volume You can independently set the technical alarm volume, touch screen click, and systole beep volume. The method for setting the three volumes are the same. To change the volume settings: In the main menu, tap Audio Volume.
Page 50 Configuring the Audio Volume User Configurations This page intentionally left blank. 4 - 6 TMS60 Operator’s Manual...
Page 51: Patient Management
Patient Management Introduction.......................5-2 Admitting a Patient ....................5-2 Changing the Patient Category ................5-2 Placing a Device in Standby.................5-3 Resume Monitoring ....................5-4 Discharging the Patient ..................5-4 TMS60 Operator’s Manual 5 - 1...
Page 52: Introduction
Introduction Patient Management Introduction The chapter describes how to admit a patient, change the patient size, enter and exit the Standby mode, and discharge the patient. Admitting a Patient When admitting a TMD860 for the first time, the device must be admitted to the system through the CS.
Page 53: Placing A Device In Standby
Patient Management Placing a Device in Standby 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 046-007960-00) for details.
Page 54: Resume Monitoring
Resume Monitoring Patient Management Resume Monitoring Press 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. Discharging the Patient Discharging the patient will stop monitoring, clear patient information, and restore default (preset) settings on the TD60.
Page 55: Restarting The Td60
Patient Management Discharging the Patient 5.6.2 Restarting the TD60 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. Select Yes if this is a new patient. Select Yes when asked to confirm that the dis- charge should begin.
Page 56 Discharging the Patient Patient Management This page intentionally left blank. 5 - 6 TMS60 Operator’s Manual...
Page 57: Alarms
Alarms Introduction.......................6-2 Alarm Categories......................6-2 Alarm Levels.......................6-2 Alarm Indicators .......................6-3 Configuring the Alarms ..................6-5 Resetting the Alarms ....................6-5 TMS60 Operator’s Manual 6 - 1...
Page 58: Introduction
Introduction Alarms Introduction Alarms, 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"...
Page 59: Alarm Indicators
Alarms Alarm Indicators Alarm Indicators When a technical alarm occurs, the TD60 notifies the user through visual or audible alarm indications. ■ Alarm light ■ Audible alarm tones ■ Alarm message NOTE • When the TD60 display is off, the user must activate the screen to view any local alarms.
Page 60: Alarm Messages
Alarm Indicators Alarms ◆ high-pitched triple beep High level alarms: ◆ double beep Medium level alarms: ◆ Low level alarms: low-pitched single beep NOTE • 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.
Page 61: Configuring The Alarms
Alarms Configuring the Alarms Configuring the Alarms ■ For details on configuring the technical alarm volume, refer to "Configuring the Audio Volume" on page 4 - 5. ■ For details on configuring the TD60 technical alarm settings, refer to "Configuring the Alarms Menu"...
Page 62 Resetting the Alarms Alarms This page intentionally left blank. 6 - 6 TMS60 Operator’s Manual...
Page 63: Monitoring Ecg
Monitoring ECG Introduction.......................7-2 Safety..........................7-2 Preparation for Monitoring ECG .................7-3 Changing the ECG Settings ..................7-11 Understanding the ECG Display .................7-14 TMS60 Operator’s Manual 7 - 1...
Page 64: Introduction
Introduction Monitoring ECG Introduction The 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 with the matching skin electrodes.
Page 65: Preparation For Monitoring Ecg
Monitoring ECG Preparation for Monitoring ECG Preparation for Monitoring ECG 7.3.1 Preparing the Patient’s Skin Proper skin preparation is essential in obtaining an accurate ECG reading. Electrode sites should be clean and dry and should provide a smooth flat surface. Incidental electrical activity and inaccurate readings may arise from incorrect skin preparation.
Page 66 Preparation for Monitoring ECG Monitoring ECG 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. NOTE •...
Page 67: Setting Ecg Lead Labeling
Monitoring ECG Preparation for Monitoring ECG 7.3.3 Setting ECG Lead Labeling 7.3.3.1 Lead Naming Standards This manual presents lead placement according to the guidelines of the American Heart Association (AHA) and the International Electro-Technical Commission (IEC). Lead position Label Color Label Color Chest...
Page 68 Preparation for Monitoring ECG Monitoring ECG 7.3.4.1 Standard 3-Leadwire Electrode Placement A 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 (IEC) 3-wire lead placement (AHA) ■...
Page 69 Monitoring ECG Preparation for Monitoring ECG 7.3.4.2 Standard 5-Leadwire Electrode Placement A 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 (IEC) 5-wire lead placement (AHA) ■...
Page 70 Preparation for Monitoring ECG Monitoring ECG 7.3.4.3 Lead Placement: Pacemaker Patients The recommended lead placement for monitoring a pacemaker patient is as follows. Pacer Pacer 3-wire Lead Placement for a Pacemaker Patient 3-wire lead placement for a pacemaker patient (IEC) (AHA) Pacer Pacer...
Page 71: Checking The Lead Placement
Monitoring ECG Preparation for Monitoring ECG 7.3.5 Checking the Lead Placement With the Lead Placement function, you can check the lead status, information, and lead off messages. 7.3.5.1 Entering the Lead Placement Menu Enter the Lead Placement menu in either of the following ways: ■...
Page 72: Checking The Paced Status
Preparation for Monitoring ECG Monitoring ECG 7.3.6 Checking the Paced Status It is important to correctly set the patient’s paced status before you start monitoring ECG. To check the paced status: ■ On the main screen, tap the HR digital area or ECG waveform area to enter the ECG menu.
Page 73: Changing The Ecg Settings
Monitoring ECG Changing the ECG Settings 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. Changing the ECG Settings You can change the ECG settings from the ECG menu. 7.4.1 Configuring the ECG Setup Enter the ECG menu in either of the following ways:...
Page 74: Ecg Leadwire Types
Changing the ECG Settings Monitoring ECG Options Description Settings* Filter Selects the ECG filter. Monitor, ST Monitor Use under normal measurement conditions. Use when ST monitoring is applied. Color Selects the ECG waveform color. 16 colors The default color is green. The factory default settings are in bold.
Page 75: Configuring The Pacer
Monitoring ECG Changing the ECG Settings Options Description Settings* Speed Selects the waveform sweep speed. 6.25 mm/s, 12.5 mm/s, 25 mm/s The factory default settings are in bold. to exit the ECG menu. 7.4.4 Configuring the Pacer In the Pacer section of the ECG menu, tap the options described in the following table.
Page 76: Configuring The Ecg Waveform Size
Understanding the ECG Display Monitoring ECG 7.4.5 Configuring the ECG Waveform Size The Waveform Size section of the ECG menu lists all available leads. You can select the desired ECG lead to set the waveform size. Understanding the ECG Display 7.5.1 HR Digital Area The HR digital area displays:...
Page 77: Ecg Waveform Area
Monitoring ECG Understanding the ECG Display 7.5.3 ECG Waveform Area The ECG waveform area displays: ECG Lead ECG scale bar ECG waveform ECG filter setting ECG scale 7.5.4 About the ECG Waveform Area ■ The ECG waveform, scale indicator, lead, and filter settings display in the configured ECG color.
Page 78 Understanding the ECG Display Monitoring ECG This page intentionally left blank. 7 - 16 TMS60 Operator’s Manual...
Page 79: Monitoring Spo2 (Optional)
Monitoring SpO (Optional) Introduction.......................8-2 Measurement Limitations..................8-2 Safety..........................8-3 Connecting the SpO2 Module ................8-4 Changing the SpO2 Settings ................8-5 SpO2 Measurement ....................8-8 Understanding the SpO2 Display ..............8-10 TMS60 Operator’s Manual 8 - 1...
Page 80: Introduction
Introduction Monitoring SpO2 (Optional) Introduction The chapter describes the SpO monitoring function at the TD60 in detail, including connecting the SpO module, configuring the SpO , and monitoring the SpO . For details about the SpO parameter setup at the central station (CS), refer to Chapter 9 Monitoring with the TD60 at the CS.
Page 81: Safety
Monitoring SpO2 (Optional) Safety ■ Dysfunctional hemoglobin, such as carboxyhemoglobin (COHb) and methemoglobin (MetHb) ■ Presence of certain dyes, such as methylene and indigo carmine ■ Inappropriate positioning of the SpO sensor, or use of incorrect SpO sensor ■ Drop of arterial blood flow to immeaurable level caused by shock, anemia, low temperature or vasoconstrictor.
Page 82: Connecting The Spo2 Module
Connecting the SpO2 Module Monitoring SpO2 (Optional) Connecting the SpO Module Connect the SpO module to the TD60. The TD60 can auto detect the SpO module type when the SpO module is connected. module sensor connector sensor Connecting the Masimo SpO module 8 - 4 TMS60 Operator’s Manual...
Page 83: Changing The Spo2 Settings
Monitoring SpO2 (Optional) Changing the SpO2 Settings module sensor connector sensor Connecting the Nonin SpO module Changing the SpO Settings You can change the SpO settings from the SpO menu. 8.5.1 Configuring the SpO Setup Enter the SPO menu in either of the following ways: ■...
Page 84 Changing the SpO2 Settings Monitoring SpO2 (Optional) Options Description Settings* Display PI Configures whether or not to show the On, Off perfusion index (PI) value in the digital area. (Masimo only) The perfusion index allows clinicians to assess the pulse strength at the monitoring site for optimal sensor placement.
Page 85 Monitoring SpO2 (Optional) Changing the SpO2 Settings Options Description Settings* Averaging The user-selectable averaging feature allows the 2-4 sec, 4-6 sec, 8 sec, 10 clinician to select the desired level of visibility to sec, 12 sec, 14 sec, 16 sec (Masimo only) subtle variations in the measured value.
Page 86: Configuring The Spo2 Waveform
SpO2 Measurement Monitoring SpO2 (Optional) 8.5.2 Configuring the SpO Waveform In the Waveform field of the SpO menu, select the options described in the fol- lowing table. Options Description Settings* Speed Selects the SpO pleth waveform speed. 6.25 mm/s, 12.5 mm/s, 25 mm/s Display SIQ Selects whether or nor to show the Signal...
Page 87 Monitoring SpO2 (Optional) SpO2 Measurement WARNING • When equipped with Masimo SpO module, use only Masimo SpO sensors specified in this manual. Use of other SpO sensors may cause improper oximeter performance. • When equipped with Nonin SpO module, use only Nonin SpO sensors specified in this manual.
Page 88: Understanding The Spo2 Display
Understanding the SpO2 Display Monitoring SpO2 (Optional) Understanding the SpO Display 8.7.1 Digital Area The SpO digital area displays: Parameter name value Perfusion indicator Perfusion index (PI) label Perfusion index value unit of measure Pulse rate (PR) label PR measurement unit PR value Masimo SpO digital area (for portrait display)
Page 89: About The Spo2 Digital Area
Monitoring SpO2 (Optional) Understanding the SpO2 Display 8.7.2 About the SpO Digital Area ■ The SpO digital area displays in units of % with a resolution of 1%. ■ The SpO PR value displays in units of bpm with a resolution of 1 bpm. ■...
Page 90: Masimo Information
Masimo Information Monitoring SpO2 (Optional) Masimo Information ■ Masimo Patents This 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 License Possession 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-...
Page 91: Monitoring With The Td60 At The Cs
Monitoring with the TD60 at the CS Introduction.......................9-2 Physiological Alarms....................9-2 ECG Monitoring ......................9-12 QT Monitoring......................9-18 ST Monitoring......................9-22 Arrhythmia Monitoring..................9-27 SpO2 Monitoring .....................9-33 TMS60 Operator’s Manual 9 - 1...
Page 92: Introduction
The chapter describes the configurations and displays at the central station (CS) once the TD60 is connected to the CS. At the CS, Mindray ECG algorithm and Mortara ECG algorithm are available. You can select either algorithm as required. Physiological Alarms At the CS, you can view and change the physiological alarm limits and alarm levels in the Alarm Setup menu.
Page 93: Factory Default Parameter Alarm Limits
Invalid data: “--” Low limit ∆QTc* High limit 30 to 200 30 to 200 Unit of measure: ms Default: 60 Default: 60 Invalid data: “--” Low limit ΔQTc is only available for Mindray ECG algorithm. TMS60 Operator’s Manual 9 - 3...
Page 94: Parameter Alarm Responses
18 to (high limit - 2) 18 to (high limit - 2) Default: 50 Default: 75 ΔQTc is only available for Mindray ECG algorithm. NOTE • The SpO Desat alarm limit is restricted such that the alarm limit can not be higher than the SpO low limit.
Page 95: Factory Default Parameter Alarm Settings
— 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 SpO Desat is not configurable. High is the only alarm level and cannot be changed.
Page 96: Factory Default Arrhythmia Alarm Settings
Physiological Alarms Monitoring with the TD60 at the CS 9.2.4 Factory Default Arrhythmia Alarm Settings 9.2.4.1 Mindray Algorithm Factory default alarm Alarm levels* responses Activation Parameters State Record Print Paging High Medium Message Switch Alarm Alarm Asystole — — —...
Page 97 Monitoring with the TD60 at the CS Physiological Alarms Factory default alarm Alarm levels* responses Activation Parameters State Record Print Paging High Medium Message Switch Alarm Alarm Pacer Not Capture Missed Beat Multif. PVC Nonsus. Vtac Pause AFib Irr.Rhythm — —...
Page 98 Physiological Alarms Monitoring with the TD60 at the CS 9.2.4.2 For Mortara Algorithm Factory default alarm Alarm levels* responses Activation Parameters State Record Print Paging High Medium Message Switch Alarm Alarm Asystole — — — VFib — — — VTac —...
Page 99 Monitoring with the TD60 at the CS Physiological Alarms Factory default alarm Alarm levels* responses Activation Parameters State Record Print Paging High Medium Message Switch Alarm Alarm Irr.Rhythm — — Pauses/min X indicates available alarm level, — indicates alarm level not available The factory default settings are in bold.
Page 100: Arrhythmia Threshold Settings
When 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 than 30 bpm, it is recommended to set asystole delay to 10 s. 9.2.5.1 Mindray ECG algorithm Unit of Arrh. event Range or Option...
Page 101 Monitoring with the TD60 at the CS Physiological Alarms 9.2.5.2 Mortara ECG algorithm Arrh. event Range or Option Default Step Unit PVCs High 1 to 100 minute Pauses/min 1 to 15 Asys. Delay 2 to 10 seconds Vtac Rate 100 to 200 Vtac PVC 3 to 12 beat...
Page 102: Ecg Monitoring
ECG Monitoring Monitoring with the TD60 at the CS ECG Monitoring At the CS, you can view and change the heart rate (HR), QT, ST, and arrhythmia settings in the ECG tab of the Parameter Setup menu. For details about the Parameter Setup menu, refer to the BeneVision Central Station Operator’s Manual (P/N 046-007960-00).
Page 103: Waveform Setup
Monitoring with the TD60 at the CS ECG Monitoring Options or Buttons Description Settings* HR Record on Alarm Select whether or not to activate the On, Off option to direct the CS to send the HR alarm data to the configured recorder. Waveform Setup Select to display the Waveform Setup Refer to "Waveform Setup"...
Page 104 ECG Monitoring Monitoring with the TD60 at the CS 9.3.2.2 Changing ECG Wave Settings In the Waveform Setup menu, you can configure the displaying leads and analysis leads as desired. The lead settings are dependent on the setting of Analysis Lead Setting. ■...
Page 105: Other Settings
Monitoring with the TD60 at the CS ECG Monitoring Settings* Options Description Lead Waveform size ECG 2 Select the desired ECG lead and set the I, II, III, aVR, aVL, × 0.125, × 0.25, × 0.5, corresponding gain for ECG 2 to display aVF, V ×...
Page 106: Ecg Display
ECG Monitoring Monitoring with the TD60 at the CS 9.3.4 ECG Display 9.3.4.1 ECG Digital Area The ECG digital area displays: Area name HR value High HR alarm limit Low HR alarm limit Pauses threshold Pauses per minute value Pauses per minute label PVCs threshold PVCs per minute value PVCs per minute label...
Page 107 Monitoring with the TD60 at the CS ECG Monitoring ECG filter setting Notch filter setting ECG waveform ECG scale ECG waveform area TMS60 Operator’s Manual 9 - 17...
Page 108: Qt Monitoring
QT Monitoring Monitoring with the TD60 at the CS QT Monitoring A normal ECG waveform (as shown in the following figure) typically includes a sharp and well defined QRS complexes with consistent spacing between R waves, and an ECG baseline that is free of noise and artifact. QT Interval 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-...
Page 109 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 Refer to "QT View Menu (Only for Mindray ECG...
Page 110: Qt View Menu (Only For Mindray Ecg Algorithm)
Monitoring with the TD60 at the CS 9.4.3 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 that the QT algorithm detects correct Q and T points.
Page 111: Qt Display
High ∆QTc alarm limit Activation State Off icon for ∆QTc alarm QT value QT label QTc label QT-HR label QT-HR value Example QT digital area (for Mindray ECG algorithm) Example QT digital area (for Mortara algorithm) TMS60 Operator’s Manual 9 - 21...
Page 112: St Monitoring
ST Monitoring Monitoring with the TD60 at the CS ST Monitoring ST deviation Depression or Elevation 40 to 80 msec ST Segment A normal ECG waveform (for ST monitoring) The ST segment of an ECG waveform (as shown in the above figure) represents the period 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.
Page 113: Measurement Limitations
Monitoring with the TD60 at the CS ST Monitoring 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. 9.5.1 Measurement Limitations ■...
Page 114: Adjusting St Measurement Points
ST Monitoring Monitoring with the TD60 at the CS 9.5.3 Adjusting ST Measurement Points The ISO and ST points need to be adjusted when you start monitoring and if the patient’s heart rate or ECG morphology changes significantly. Exceptional QRS com- plexes are not considered for ST-segment analysis.
Page 115: St Display
Monitoring with the TD60 at the CS ST Monitoring Buttons Description Settings* ISO/J Selecting Auto fixes the ISO and J/ST Auto, Manual points. Selecting Manual allows the clinician to manually adjust ISO and J/ST points. 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.
Page 116: St Segment Display
ST Monitoring Monitoring with the TD60 at the CS 9.5.5 ST Segment Display When Display ST Segments is enabled, the ST segments display in the waveform area: Lead identifier ST markers (ISO, J/ST) ST value ECG scale 3-lead ST segment 5-lead ST segments 9 - 26 TMS60 Operator’s Manual...
Page 117: Arrhythmia Monitoring
Therefore, closely monitor the patient’s condition during the learning phase and after the learning phase to allow the algorithm to reach optimal detection performance. 9.6.2 Understanding the Arrhythmia Events 9.6.2.1 Mindray ECG Algorithm Arrhythmia message Description Category Asystole No QRS detected within the set time threshold in absence of ven- Lethal tricular fibrillation or chaotic signal.
Page 118 Arrhythmia Monitoring Monitoring with the TD60 at the CS Arrhythmia message Description Category Vent. Brady The consecutive PVCs ≥ the Vbrd threshold and the ventricular HR < Lethal the Vbrd Rate threshold. arrhythmia Extreme Tachy The heart rate is equal to or greater than the extreme tachycardia limit.
Page 119 Monitoring with the TD60 at the CS Arrhythmia Monitoring 9.6.2.2 Mortara ECG Algorithm Arrhythmia message Description Category Asystole No QRS complex detected within the set time threshold (in absence Lethal of ventricular fibrillation or chaotic signals). arrhythmia VFib 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.
Page 120: Arrhythmia Settings
Arrhythmia Monitoring Monitoring with the TD60 at the CS 9.6.3 Arrhythmia Settings The following table lists the arrhythmia settings in the Arrhythmia Analysis section of the ECG tab. Options or Buttons Description Settings* Arrhythmia Alarms Configures the arrhythmia alarm settings. Refer to "Factory Default Arrhyth- mia Alarm Settings"...
Page 121: Configuring The Qrs Threshold
Monitoring with the TD60 at the CS Arrhythmia Monitoring ■ Significant changes occurred to the patient ECG rhythm ■ A clinician has observed clinically questionable arrhythmia calls ■ “Learning” occurred during a Leads Off condition CAUTION • Initiate ECG relearning only during periods of normal rhythm and when the ECG signal is relatively noise-free.
Page 122 Arrhythmia Monitoring Monitoring with the TD60 at the CS Minimum QRS Threshold menu The current waveform displays the data of previous eight seconds. Use the buttons described in the following table as desired. Buttons Description Settings* Gain Select the desired ECG waveform size. X1, X2, X4 Refresh Displays the real-time waveform.
Page 123: Spo2 Monitoring
Monitoring with the TD60 at the CS SpO2 Monitoring Monitoring At the CS, you can view and change the SpO settings in the SpO tab of the Parameter Setup menu. For details about the Parameter Setup menu, refer to the BeneVision Central Station Operator’s Manual (P/N 046-007960-00).
Page 124: Spo2 Display
SpO2 Monitoring Monitoring with the TD60 at the CS Options Description Settings* Desat Limit (%) Configures the SpO Desat low limit. 0 to 100 The default is 80. Averaging The option is not configurable. The option setting is synchronous with the set- ting at the TD60.
Page 125 Monitoring with the TD60 at the CS SpO2 Monitoring NOTE • When HR Source of the ECG tab is set to Both, the PR value displays on the SpO digital area. Nonin SpO digital area 9.7.3.2 Waveform Area The SpO waveform area displays: Area name Pleth waveform...
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Page 127: Configuring The Td60
Configuring the TD60 Introduction.......................10-2 Maintenance Menu ....................10-2 TMS60 Operator’s Manual 10 - 1...
Page 128: Introduction
Introduction Configuring the TD60 10.1 Introduction This TD60 Maintenance menu provides access to the system settings such as location, device name, alarm settings, quick keys, screen lock, and password updates. Entering this menu requires a password. 10.2 Maintenance Menu The Maintenance menu contains the following submenus: ■...
Page 129: Configuring The Alarms Menu
Mode 1, Mode 2 The factory default settings are in bold. to exit the General menu. NOTE • Mindray recommends the same SpO tone mode be used for the device within a monitoring area. 10.2.3 Configuring the Alarms Menu Select Alarms to configure the alarm tone, reminder tone, reminder interval, minimum alarm volume, and technical alarm priority.
Page 130 Maintenance Menu Configuring the TD60 Section & Options Description Settings* Style Allows an authorized user to set the alarm tone ISO, Mode 1, Mode 2 pattern. Timeout Reminder Tone Allows an authorized user to enable or disable On, Off the reminder tone. If the alarm tone is turned off, enabling this set- ting can issue a periodic reminder tone.
Page 131: Quick Keys Menu
Configuring the TD60 Maintenance Menu WARNING • When the technical alarm audio volume is set to alarm sound and the alarm sound is turned off, the TD60 will not enunciate technical alarms when they occur. Be careful when turning off the alarm volume. •...
Page 132: Configuring The Defaults Menu
Maintenance Menu Configuring the TD60 A list of options Tap the desired option from the list of options to configure the selected quick key. Repeat steps 2 to 3 to configure other quick keys, if needed. to exit the Quick Keys menu. 10.2.4.2 Deleting a Quick Key From the quick keys area at the bottom of the Quick Keys menu, press and hold...
Page 133: Transferring A Configuration
Configuring the TD60 Maintenance Menu Options Description 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.
Page 134: Screen Lock Menu
Maintenance Menu Configuring the TD60 ◆ 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 is successful.
Page 135: Changing The Passwords
Configuring the TD60 Maintenance Menu 10.2.7.3 Changing the Current Screen Lock Passcode In the Maintenance menu, tap Screen Lock. Tap Screen Lock Passcode. Input the current password. Input and verify the new password 10.2.8 Changing the Passwords In the Maintenance menu, tap Edit Passwords. ◆...
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Page 137: Battery
Battery Introduction.......................11-2 Safety..........................11-2 Installing the Battery ....................11-3 Checking the Battery Charge Status ..............11-4 Removing the Battery ....................11-4 Charging the Rechargeable Lithium-ion Battery .........11-5 Storing the Batteries ....................11-6 Maintaining the Rechargeable Lithium-ion Battery........11-7 Disposing of the Batteries..................11-8 TMS60 Operator’s Manual 11 - 1...
Page 138: Introduction
Introduction Battery 11.1 Introduction The 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 Safety WARNING • Keep the batteries out of children’s reach. •...
Page 139: Installing The Battery
Battery Installing the Battery 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.
Page 140: Checking The Battery Charge Status
Checking the Battery Charge Status Battery 11.4 Checking the Battery Charge Status The battery symbol displaying on the top of main screen indicates the battery charge status. The white part ( ) indicates the remaining battery charge. NOTE • If the “Low Battery” or “Critically Low Battery” alarm occurs, the TD60 turns off the audio, the screen display the “Local Audio Off”...
Page 141: Charging The Rechargeable Lithium-Ion Battery
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.
Page 142: Storing The Batteries
Storing the Batteries Battery 11.7 Storing the Batteries 11.7.1 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).
Page 143: Maintaining The Rechargeable Lithium-Ion Battery
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.
Page 144: Disposing Of The Batteries
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. 11.9 Disposing of the Batteries 11.9.1...
Page 145: Troubleshooting
Troubleshooting General Problems ....................12-2 Physiological Alarm Messages at the CS ............12-3 Technical Alarm Messages at the TD60 ............12-5 TMS60 Operator’s Manual 12 - 1...
Page 146: General Problems
General Problems Troubleshooting 12.1 General Problems The following table lists the problems that are likely to occur. If the problem persists after corrective actions have been taken, contact your service personnel. 12.1.1 Troubleshooting Tools ■ Telemetry Receiver (RC60) ■ TD60 ■...
Page 147: Physiological Alarm Messages At The Cs
Troubleshooting Physiological Alarm Messages at the CS Symptom Possible cause Solution The AC power The RC60 is not connected to the Check if the RC60 is connected indicator on the RC60 power. to the power. is off. The RC60 is power off. Check if the RC60 sounds a beep when turn the receiver on.
Page 148 Physiological Alarm Messages at the CS Troubleshooting Measurement Alarm message Alarm level Possible cause Solution ECG Weak Signal High The ECG signal is so weak Check the patient’s that the monitor can’t condition and the ECG perform ECG analysis. connections. Asystole High The patient is in...
Page 149: Technical Alarm Messages At The Td60
Troubleshooting Technical Alarm Messages at the TD60 Measurement Alarm message Alarm level Possible cause Solution Desat High The SpO value has fallen Check the patient’s condition and check if below the desaturation the alarm limit settings alarm limit. are correct. No Pulse High The pulse signal was so...
Page 150 Reconnect the SpO Unplugg is disconnected from the module to the TD60. TD60. The measured PR value Contact Mindray or Overrang exceeds the your service measurement range. personnel. The asterisk (*) means the alarm level is configurable. XX is the ECG lead name.
Page 151 Error main board is error. the problem persists, contact your service personnel. The selftest of the parameter module or Mindray PAN module are error. The parameter module communication is error or initialization is error. Real High The real time clock Time initialization is error.
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Page 153: Cleaning And Disinfecting
Cleaning and Disinfecting Introduction.......................13-2 Safety Information....................13-2 Cleaning of the TD60....................13-3 Cleaning the Reusable ECG Leadwires, SpO2 Modules and Sensors ..13-4 Cleaning the Battery and Battery Compartment .........13-5 Disinfection........................13-5 Sterilization ........................13-5 TMS60 Operator’s Manual 13 - 1...
Page 154: Introduction
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 a means for controlling infection. For the method to control infection, consult your hospi- tal’s Infection Control Officer or Epidemiologist.
Page 155: Cleaning Of The Td60
Cleaning and Disinfecting Cleaning of the TD60 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.
Page 156: Cleaning The Reusable Ecg Leadwires, Spo2 Modules And Sensors
Cleaning the Reusable ECG Leadwires, SpO2 Modules and Sensors Cleaning and Disinfecting Dilute the mild soap in water to make a cleaning solution. Soak a clean and soft cloth in the solution and wring out excess solution. Thoroughly wipe the display screen and the exterior surface of the device with the damp cloth, avoiding the connectors.
Page 157: Cleaning The Battery And Battery Compartment
Cleaning and Disinfecting Cleaning the Battery and Battery Compartment 13.5 Cleaning the Battery and Battery Compartment ■ Clean the exterior surface of the lithium-ion battery pack and AA battery tray before and after each new patient. ■ Wipe the lithium-ion battery pack, AA battery tray and the battery compartment using a soft cloth with mild soap and water solution.
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Page 159: Maintenance
Maintenance Introduction.......................14-2 Safety..........................14-2 Regular Check ......................14-3 Maintenance and Testing Schedule..............14-4 Checking the System Information ..............14-4 Verifying the ECG at the TD60 ................14-4 TMS60 Operator’s Manual 14 - 1...
Page 160: Introduction
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.
Page 161: Regular Check
Maintenance Regular Check 14.3 Regular Check Perform a visual inspection before the equipment is first used every day. Verify that the equipment meets the following requirements: ■ The housing and display screen are free from cracks or other damages. ■ All keys function properly.
Page 162: Maintenance And Testing Schedule
Maintenance and Testing Schedule Maintenance 14.4 Maintenance and Testing Schedule The following maintenance and tests, except for visual inspection, power on test, and battery check, shall be carried out by the service personnel only. Contact your service personnel if any maintenance is required. Make sure to clean and disinfect the equip- ment before any test and maintenance.
Page 163 Maintenance Verifying the ECG at the TD60 A square wave appears on the screen and the message ECG Calibrating is dis- played. Compare the amplitude of the square wave with the wave scale. The difference should be within 5%. After completing the verification, disable Calibrate ECG. TMS60 Operator’s Manual 14 - 5...
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Page 165: Accessories
Accessories ECG Accessories......................15-2 SpO2 Accessories .....................15-3 Miscellaneous......................15-5 TMS60 Operator’s Manual 15 - 1...
Page 166: Ecg Accessories
ECG Accessories Accessories The accessories listed in this chapter comply with the requirements of IEC 60601-1-2 when in use with the device. The accessory material that contacts the patients has undertaken the bio-compatibility test and is verified to be in compliance with ISO 10993-1.
Page 167: Ecg Leadsets
Accessories SpO2 Accessories 15.1.2 ECG Leadsets 3-Lead Applicable Applicable Description property patient 009-004765-00 3-Lead, New Telemetry, AHA, Snap, 24" Reusable Adult, Pediatric 009-004766-00 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"...
Page 168: Nonin Spo2 Sensor
SpO2 Accessories Accessories 15.2.2 Masimo SpO Sensor Applicable Applicable Description property patient 0600-00-0121 LNCS Adtx-Adult Single Patient Adhesive Sen- Disposable Adult sors, >30 kg (20/box) 0600-00-0122 LNCS Pdtx-Pediatric Single Patient Adhesive Pediatric Sensors,10-50 kg (20/box) 0600-00-0126 LNCS DCI Adult Reusable Finger Sensor, >30 kg Reusable Adult 0600-00-0127...
Page 169: Miscellaneous
Accessories Miscellaneous 15.3 Miscellaneous Description 115-026852-00 Main unit of the charger 022-000196-00 Telemetry Rechargeable battery 045-001698-00 TP-2AA battery frame 045-001699-00 TP-3AA battery frame 0000-10-10902 Alkaline 1.5 V AA battery 0146-00-0077-10 L91 AA battery 048-005247-00 Disposable pouch 048-005246-00 Reusable pouch TMS60 Operator’s Manual 15 - 5...
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Page 171 Product Specifications Classifications......................A-2 Environmental Specifications................A-2 Power Supply Specifications................A-3 Physical Specifications ...................A-4 Hardware Specifications..................A-5 WMTS Specification ....................A-7 Mindray Patient Area Network (MPAN) Specification.........A-9 Measurement Specifications ................A-10 TMS60 Operator’s Manual A - 1...
Page 172: A Product Specifications
Classifications Product Specifications Classifications The Telemetry Monitoring System is classified, according to IEC60601-1: TD60: energized from an internal electrical power source. Type of protection against electrical RC60: class I. shock Central Charger: class I. Type CF defibrillation proof for ECG, and SpO Degree of protection against electrical shock for the TD60 Continuous...
Page 173: Power Supply Specifications
Product Specifications Power Supply Specifications Power Supply Specifications A.3.1 TD60 The TD60 is powered by batteries. AA batteries (two or three) Battery type Rechargeable lithium-ion battery (one) ≥ 3500 mAh Capacity for lithium-ion battery UL2054, IEC62133, UN38.3 Safety and authentication for lithium-ion battery Two AA Three AA...
Page 174: Central Charger
Physical Specifications Product Specifications A.3.3 Central Charger The central charger is powered by external AC power. 100 VAC to 240 VAC (± 10%) Input voltage 50 Hz/60 Hz (±3 Hz) Frequency 1.5 A to 0.75 A Input current At the room temperature: ≤ 5 hours Charge time The charge time definition: the time for the battery from the exhausted status to 90% battery charge (within the operating...
Page 175: Hardware Specifications
Product Specifications Hardware Specifications Hardware Specifications A.5.1 TD60 Display Color TFT LCD screen Screen type 3.5" Screen size 480 pixels × 320 pixels Resolution The switch time is less than or equal to two seconds. Display Activation (Power On/Off) key 1 (three colors: red, yellow, and cyan) Alarm lamp Audio Indicator...
Page 176: Rc60
Hardware Specifications Product Specifications A.5.2 RC60 1 (green), indicates the ready and communications status. Communications indicator 1 (green), indicates the power status. Power indicator Audio Indicator 1, indicates internal abnormity. Buzzer External Connectors 1, standard RJ45 connector Ethernet connector Antenna connector A.5.3 Central Charger Charger slot...
Page 177: Wmts Specification
Product Specifications WMTS Specification WMTS Specification A.6.1 Technical Specification Private protocol Protocol standard GFSK Modulation mode 608 MHz to 614 MHz Operating frequency 25 KHz Channel spacing 8 kbps ± 3% Wireless baud rate < 10 mW Output power ≤-110 dBm (Bit error rate ≤ 1% ) Receiversensitivity Private protocol Data security...
Page 178: Performance Specification
WMTS Specification Product Specifications A.6.3 Performance Specification WARNING • Do perform all network functions of data communication within an enclosed network. Bit error rate: ≤ 1% Data integrity Total delay of data transmission from the transmitter to the CS: Data latency ≤...
Page 179: Mindray Patient Area Network (Mpan) Specification
Product Specifications Mindray Patient Area Network (MPAN) Specification Mindray Patient Area Network (MPAN) Specifica- tion A.7.1 Technical Specification GFSK Modulation mode 2402MHz to 2480MHz Operating frequency 2 MHz Channel spacing 1 Mbps Wireless baud rate ≤ 2.5 mW Output power...
Page 180: Measurement Specifications
Measurement Specifications Product Specifications Measurement Specifications A.8.1 Meet standards of IEC60601-2-27 and IEC60601-2-25 Standard 3-lead: I, II, III Leadset 5-lead: I, II, III, aVR, aVL, aVF, V Automatic 3/5 lead recognition AHA, IEC ECG standard 6.25 mm/s, 12.5 mm/s, 25 mm/s Sweep speed Accuracy: ±...
Page 181 Measurement range Pediatric: 15 bpm to 350 bpm 1 bpm Resolution ± 1 bpm or ± 1%, whichever is greater. Accuracy Mindray ECG algorithm Mortara ECG algorithm Sensitivity 200 μV 160 μV to 480 μV TMS60 Operator’s Manual A - 11...
Page 182 Measurement Specifications Product Specifications Mindray ECG algorithm Mortara ECG algorithm In compliance with the In compliance with the requirements in Clause requirements in Clause 201.7.9.2.9.101 b) 3) of 201.7.9.2.9.101 b) 3) of IEC60601-2-27, the following IEC60601-2-27, the following method is used:...
Page 183 -0.8 mV to +0.8 mV: ± 0.02 mV or ± 10%, whichever is greater Accuracy Beyond this range: Not specified Arrhythmia Analysis Mindray ECG algorithm Mortara ECG algorithm Asystole, VFib/VTac, Vtac, Vent. Asystole, VFib, Vtac, Extreme Brady, Extreme Tachy, Extreme...
Page 184: Spo2
Measurement Specifications Product Specifications A.8.2 NOTE • A functional tester or SpO simulator can be used to determine the pulse rate accuracy. A.8.2.1 Nonin SpO Module 0% to 100% Measurement range Resolution 70-100%: ±3 digits Accuracy 0-69%: Not specified ≤2s Data update rate *Studies were performed to validate the accuracy of Pulse Oximeter with Nonin SpO sensors by contrast with a...
Page 185 Product Specifications Measurement Specifications ±3 bpm Accuracy Response Time ■ ≤ 25 s (PR 75 bpm, average time 4 heart beats, no disturbance, SpO value rises from 70% to 100%) ■ ≤ 35 s (SpO value 98%, average time 4 heart beats, no disturbance, PR value rises from 60 bpm to 150 bpm) A.8.2.2 Fitting Curve for Nonin SpO...
Page 186: Masimo Spo2 Sensor
Measurement Specifications Product Specifications Bland-Altman Plots of the Bias versus the Mean A.8.2.3 Masimo SpO Module 1% to 100% Measurement range Resolution 70 to 100%: ±2% (measured without motion in adult/pediatric mode) Accuracy 70 to 100%: ±3% (measured with motion) 1% to 69%: Not specified.
Page 187 Product Specifications Measurement Specifications Measured A Values range LNCS Adtx, LNCS Pdtx LNCS DCI, LNCS DCIP 70% to 100% ± 2% 70% to 80% 1.55% 0.60% 80% to 90% 1.07% 0.54% 90% to 100% 1.64% 0.60% 25 bpm to 240 bpm Measurement range 1 bpm Resolution...
Page 188 Measurement Specifications Product Specifications A.8.2.4 Fitting Curve for Masimo SpO Sensors A - 18 TMS60 Operator’s Manual...
Page 189 TMS60 Operator’s Manual B - 1...
Page 190 The 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.
Page 191 Guidance and declaration — electromagnetic immunity The 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. IEC 60601 Test Compliance Immunity test Electromagnetic environment - guidance level level Electrostatic...
Page 192 Guidance and declaration — electromagnetic immunity The 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. IEC 60601 Test Compliance Immunity test Electromagnetic environment - guidance level...
Page 193 If the system is operated within the electromagnetic environment listed in Table Guid- ance and declaration — electromagnetic immunity, the system will remain safe and provide the following essential performance: ■ Operating mode ■ Accuracy ■ Function ■ Accessories identification ■...
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Page 195: C Fcc Compliance
FCC Compliance The 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 potential for interference with other wireless medical telemetry devices, or other co-primary users.
Page 196 FCC Compliance NOTE ●...
Page 197 FCC Compliance 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 TMS60 Operator’s Manual ...
Page 198 FCC Compliance RF Parameters Item Parameter Operating Frequency Band (MHz) 608 to 614 Modulation GFSK Transmitter Output Power(e.i.r.p) (dBm) < 10 Channel Space (KHz) C - 4 TMS60 Operator’s Manual...
Page 199: D Symbols And Abbreviations
Symbols and Abbreviations Units..........................D-2 Symbols ........................D-3 Abbreviations ......................D-3 TMS60 Operator’s Manual D - 1...
Page 200: Units
Units Symbols and Abbreviations Units ampere ampere hour beats per minute °C centigrade cubic centimeter centimeter decibel dyne. second °F fahrenheit gram hour hundred pascal hertz inch kilo kilogram kilopascal litre pound meter milligrams minute milliliter millimeters millisecond millivolt milliwatt nanometer part per million second...
Page 201: Symbols
Symbols and Abbreviations Symbols μV microvolt watt Symbols 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 ©...
Page 202 Abbreviations Symbols and Abbreviations error electrosurgical electrosurgical unit heart rate height International Electrotechnical Commission International organization for standardization magnetic resonance imaging LA(L) left arm left atria pressure light emitting diode LL(F) left leg Loop loop read-write test fail M, MEAN mean pressure oxygen power...
Page 203: E Anomaly
Anomaly Anomaly Description This product version contains no anomalies. TMS60 Operator’s Manual E - 1...
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Page 206 P/N: 046-007056-00 (2.0)

Mindray BeneVision TMS60 Operator's Manual

1 Safety

2 General Product Description

3 Getting Started

4 User Configurations

5 Patient Management

6 Alarms

7 Monitoring ECG

8 Monitoring Spo2 (Optional)

9 Monitoring with the TD60 at the CS

10 Configuring the TD60

11 Battery

12 Troubleshooting

13 Cleaning and Disinfecting

14 Maintenance

15 Accessories

A Product Specifications

C FCC Compliance

D Symbols and Abbreviations

E Anomaly

Quick Links

Troubleshooting

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Summary of Contents for Mindray BeneVision TMS60