Mindray BeneVision TM80 Operator's Manual

Mindray BeneVision TM80 Operator's Manual

Telemetry monitor
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TM80 Telemetry Monitor
Operator's Manual

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Summary of Contents for Mindray BeneVision TM80

  • Page 1 BeneVision TM80 Telemetry Monitor Operator’s Manual...
  • Page 3 Introduction © Copyright 2019 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. All rights reserved. ■ Release time: 2019-09 Revision: 3. 0 ■ WARNING • Federal Law (USA) restricts this device to sale by or on the order of a phy- sician or other practitioner licensed by U.S. state law to use or order the use of this device.
  • Page 4 , 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.
  • Page 5 Neglect of this may result in machine breakdown or personal injury. Company Contact Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Address: Mindray Building, Keji 12th Road South, High-tech Industrial park, Nanshan, Shenzhen 518057, P.R.China Website: www.mindray.com E-mail Address: service@mindray.com...
  • Page 6 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 7: 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 - 5 1.1.3 Notes ..............................1 - 6 1.2 Equipment Symbols ..........................1 - 7 2 General Product Description ....................2 - 1 2.1 Intended for Use ............................
  • Page 8 4.1 Introduction ..............................4 - 2 4.2 Configuring the Display ........................... 4 - 2 4.2.1 Setting the Default Display Orientation ................4 - 2 4.2.2 Understanding Portrait Orientation Display Rules ............4 - 2 4.2.3 Setting the Portrait Display ..................... 4 - 3 4.2.4 Understanding Landscape Orientation Display Rules ...........
  • Page 9 7.1 Introduction ..............................7 - 2 7.2 ECG Safety Information ..........................7 - 2 7.3 Preparation for Monitoring ECG ......................7 - 3 7.3.1 Preparing the Patient’s Skin ....................7 - 3 7.3.2 Positioning the Electrodes ....................... 7 - 3 7.3.3 Configuring the ECG Lead Labeling ..................
  • Page 10 8.1 Introduction ..............................8 - 2 8.2 Resp Safety Information ........................... 8 - 2 8.3 Preparation for Monitoring Resp ......................8 - 3 8.3.1 Preparing the Patient’s Skin ....................8 - 3 8.3.2 Positioning the Electrodes ....................... 8 - 3 8.4 Changing Resp Settings ...........................
  • Page 11 10.3.3 System Responses after Successful Unpairing .............10 - 5 10.4 Screen Display after Pairing a TM80 with a BP10 ...............10 - 6 10.5 Interactions after Pairing a TM80 with a BP10 ................10 - 7 10.5.1 Overview of Interactions ......................10 - 7 10.5.2 Operating the BP10 via the TM80 ..................10 - 7 10.5.3 Configuring NIBP Settings ....................10 - 8 10.5.4 Configuring NIBP Alarm Settings ..................10 - 8...
  • Page 12 12.11 Setting CMS Disconnect Alarm ....................12 - 17 12.12 Demo Mode ............................12 - 18 12.13 Service Menu ............................12 - 18 13 Monitoring with the TM80 at the CMS ................13 - 1 13.1 Introduction .............................13 - 2 13.2 Network Safety Information .......................13 - 3 13.3 Adjusting the Minimum QRS Detection Threshold ..............13 - 3 13.4 QT Monitoring ............................13 - 4...
  • Page 13 16.2 Safety Information ..........................16 - 2 16.3 Cleaning and Disinfecting the Equipment ...................16 - 3 16.3.1 Approved Cleaning and Disinfecting Agents ...............16 - 3 16.3.2 Cleaning the Equipment ......................16 - 5 16.3.3 Disinfecting the Equipment ....................16 - 7 16.4 Cleaning and Disinfecting ECG Leadwires and SpO2 Sensors ..........16 - 7 16.5 Cleaning and Disinfecting Other Parts ...................16 - 8 16.6 Sterilization ..............................16 - 9 16.7 Impact of Improper Cleaning or Disinfection ................16 - 9...
  • Page 14 A.5.2 Central Charger ...........................A - 6 A.6 Data Storage ..............................A - 6 A.7 Wireless Specification ..........................A - 6 A.7.1 Mindray Patient Area Network (MPAN) Specification ...........A - 6 A.7.2 Wi-Fi Specifciations ........................A - 8 A.8 Measurement Specifications ....................... A - 10 A.8.1 ECG ..............................
  • Page 15: Safety

    Safety Safety Information....................1-2 Equipment Symbols....................1-7 TM80 Telemetry Monitor 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 TM80 Telemetry Monitor is intended to be used for a single patient at a time. • The TM80 Telemetry Monitor must be operated by medical personnel in hospitals. • For continued safe use of the TM80 Telemetry Monitor, the instructions given in this manual must be followed.
  • Page 18 Safety Information Safety WARNING • 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 patient monitor- ing. Adjustment of alarm volume to a low level may result in a hazard to the patient.
  • Page 19: Cautions

    If a life-threatening situation occurs for a patient, this patient must be located and found by medical staff immediately. • Mindray takes no responsibility for controlling the radio frequency envi- ronment in a hospital. If interference for the operating frequency of telemetry equipment exists, the telemetry equipment performance will be affected.
  • Page 20: Notes

    Safety Information Safety CAUTION • When the patient carrying a TM80 Telemetry Monitor moves in a hospi- tal, signal quality can be impacted on an ambulatory patient by the con- struction materials used within the hospital. • At the end of its service life, the TM80 Telemetry Monitor and its acces- sories must be disposed of in compliance with the guidelines regulating the disposal of such products to prevent bringing potential negative consequences to the environment and human health.
  • Page 21: Equipment Symbols

    Safety Equipment Symbols Equipment Symbols Symbol Description Symbol Description Power On/Off key Main menu key Nurse call key Symbol for aligning the connector Charge indicator Alternating current DEFIBRILLATION-PROOF Serial number TYPE CF APPLIED PART Date of Manufacture Manufacturer MR Unsafe – do not sub- Protection against fluid IPX7 ject to magnetic reso-...
  • Page 22 Equipment Symbols Safety NOTE • Some symbols may not appear on your equipment. 1 - 8 TM80 Telemetry Monitor Operator’s Manual...
  • Page 23: General Product Description

    General Product Description Intended for Use.......................2-2 Applied Parts ......................2-2 Key Features.......................2-3 Components ......................2-3 Physical View ......................2-4 Touch Screen Display....................2-5 TM80 Telemetry Monitor Operator’s Manual 2 - 1...
  • Page 24: Intended For Use

    Intended for Use General Product Description Intended for Use The TM80 telemetry monitor is intended for use on Adult and Pediatric patients over three years old to monitor ECG, SpO , NIBP and Resp physiological data. The physiologi- cal data can be analyzed, alarmed, stored, reviewed locally on the display of the monitor, and the CentralStation can config and display the physiological parameters from the TM80.
  • Page 25: Key Features

    General Product Description Key Features Key Features ■ 3.5" color PTC touch screen display is easy for clinicians to use. ■ Small, portable, and lightweight for patients to wear. ■ Supports 3/5/6-lead ECG. ■ Supports Masimo SpO moduleand Nellcor SpO module.
  • Page 26: Physical View

    Physical View General Product Description Physical View Display Activation (Power On/Off ) key ■ When the device is powered off, pressing this button will turn it on. ■ When the device is powered on: ◆ And the screen display is on, pressing this key will turn the display off. ◆...
  • Page 27: Touch Screen Display

    General Product Description Touch Screen Display Display The touch screen is the primary user interface for operating the device and view- ing information (or patient data). Alarm light/indicator Flashes in different color and frequency corresponding to the alarm level. ECG connector Connects the ECG leadset.
  • Page 28: Display Screen

    : indicates the alarm audio is turned off. ◆ : indicates that alarms are acknowledged and the alarm system is reset. Mindray Patient Area Network (herein abbreviated as MPAN) indicator ◆ indicates that the TM80 is not paired with the BP10 or one TM80 is not connected to another TM80 for configuration transfer.
  • Page 29 General Product Description Touch Screen Display ◆ indicates that the TM80 has been connected to the Wi-Fi access point and the signal coverage is good. Stable data transmission via Wi-Fi network can be guaranteed. ◆ indicates that the TM80 has been connected to the Wi-Fi access point and the signal coverage can basically meet the requirements.
  • Page 30: On-Screen Keyboard

    Touch Screen Display General Product Description 2.6.2 On-Screen Keyboard The TM80 uses an on-screen keyboard to enter alphanumeric information, such as the device name and passwords. 2.6.2.1 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 31 General Product Description Touch Screen Display Space button: tap to input a space. Alphabetic switch button: tap to switch to the alphabetic layout. More punctuation buttons: tap to display the punctuation keyboard, as shown below. TM80 Telemetry Monitor Operator’s Manual 2 - 9...
  • Page 32 Touch Screen Display General Product Description This page intentionally left blank. 2 - 10 TM80 Telemetry Monitor Operator’s Manual...
  • Page 33: Getting Started

    Getting Started Unpacking and Checking..................3-3 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 TM80 Telemetry Monitor Operator’s Manual 3 - 1...
  • Page 34 The TM80 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.
  • Page 35: Unpacking And Checking

    Unpacking and Checking Before 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 accessories carefully.
  • Page 36: Connecting The Ecg Leadwire

    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 Align the ECG leadwire plug with the ECG connector as indicated by the arrow in the following figure.
  • Page 37: 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 ◆ Water resistance • Do not use the ECG leadwire to move or lift the TM80. This may cause the device to fall, which may damage the equipment or injure the patient.
  • Page 38: Installing The Lithium-Ion Rechargeable Battery Pack

    Installing the Batteries Getting Started 3.4.1 Installing the Lithium-ion Rechargeable Battery Pack 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 39: Installing The Aa Batteries

    Getting Started Installing the Batteries 3.4.2 Installing the AA Batteries To install the AA batteries: Make sure the battery compartment is empty. Insert three 1.5V alkaline AA batteries according to the diagram in the bottom of the battery tray as shown in the images below. 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.
  • Page 40: Powering On The Unit

    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. 3 - 8 TM80 Telemetry Monitor Operator’s Manual...
  • Page 41: Understanding Touch Gestures

    Getting Started Understanding Touch Gestures Understanding Touch Gestures Before using the TM80, understand the supported touch screen gestures: Gesture Description Briefly touch the surface with your fingertip to select a target. Touch the surface for extended period of time. Press and hold Move your fingertip over the surface without losing contact.
  • Page 42: Understanding The Screen Display Orientation

    Basic Operations Getting Started 3.7.1 Understanding the Screen Display Orientation The TM80 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 43: Displaying The Quick Keys Area

    Getting Started Basic Operations ◆ : this button is displayed in landscape orientation. It switches landscape display to portrait display. Select the desired button. 3.7.4 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 nine default quick keys: Quick keys Description...
  • Page 44: Entering The Main Menu

    Basic Operations Getting Started 3.7.5 Entering the Main Menu Press the key to enter the main menu. The main menu allows access to most of the system functions and settings. All menus contain the following parts: Heading: displays the current menu title. Scroll bar: drag the bar to scroll the menu.
  • Page 45: Turning The Display Off

    Getting Started Basic Operations 3.7.6 Turning the Display Off You can manually turn the display off, or let the display automatically turn off based on the 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 the screen will turn off after the configured Display Auto Off time has elapsed.
  • Page 46: Unlocking The Screen In View Only Mode

    Using the Pouch Getting Started 3.7.9 Unlocking the Screen in View Only Mode If the screen is off, press the key to turn the display on. Press the key to display the Screen Locked menu. Input the passcode to unlock the screen. Once the passcode is entered the screen is temporarily unlocked.
  • Page 47: Securing The Pouch For The Tm80

    Getting Started Using the Pouch CAUTION • If a patient needs to take a shower, check the TM80 as described in "Reg- ular Check" on page 17 - 3 before showering, use the specified disposable pouch only, and secure the pouch on the patient as described in this sec- tion.
  • Page 48 Using the Pouch Getting Started Wearing the disposable pouch WARNING • While using a pouch with the TM80 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 •...
  • Page 49: Securing Pouches For The Tm80 And Bp10

    Getting Started Using the Pouch 3.8.2 Securing Pouches for the TM80 and BP10 When a patient wears the pouches for the TM80 and BP10 simultaneously, follow steps in 3.8.1 Securing the Pouch for the TM80 to secure the pouch for the TM80 on the left or right side of the patient’s body and follow steps in BP10 Operator’s Manual to secure the pouch for the BP10 on the right or left side of the patient’s body, as shown in the fol- lowing figures.
  • Page 50 Using the Pouch Getting Started This page intentionally left blank. 3 - 18 TM80 Telemetry Monitor Operator’s Manual...
  • Page 51: User Configurations

    User Configurations Introduction.......................4-2 Configuring the Display..................4-2 Configuring the Audio Volume................4-4 TM80 Telemetry Monitor Operator’s Manual 4 - 1...
  • Page 52: Introduction

    Introduction User Configurations Introduction This chapter gives you an overview of basic operations related to the TM80, such as con- figuring the Display Setup, and Audio Volume. Configuring the Display You can configure the display by setting the display layout, display orientation, and screen brightness.
  • Page 53: Setting The Portrait Display

    User Configurations Configuring the Display 4.2.3 Setting the Portrait Display In the Portrait 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 Portrait Order to enter the Portrait Order menu.
  • Page 54: Setting The Display Brightness

    Configuring the Audio Volume User Configurations Tap a parameter or waveform option to select it. icon displays to the right side of the selected parameter or waveform. Drag the selected parameter or waveform to the desired position, and then release Repeat steps 4 and 5 until the desired order is configured.
  • Page 55 User Configurations Configuring the Audio Volume NOTE • When Minimum Alarm Volume is set to Off and Sounds is turned off, the icon is displayed on the main screen. It indicates that the alarm sound is turned off. • When your TM80 is connected to the CMS and Sounds is turned off, Sounds automatically changes to 2 if the CMS is disconnected.
  • Page 56 Configuring the Audio Volume User Configurations This page intentionally left blank. 4 - 6 TM80 Telemetry Monitor Operator’s Manual...
  • Page 57: Patient Management

    Patient Management Introduction.......................5-2 Admitting a Patient ....................5-2 Changing Patient Information ................5-2 Entering the Standby Mode.................5-5 Exiting the Standby Mode ..................5-5 Discharging the Patient ..................5-6 TM80 Telemetry Monitor Operator’s Manual 5 - 1...
  • Page 58: Introduction

    Introduction Patient Management Introduction The chapter describes how to admit a patient, change patient information, enter and exit the Standby mode, and discharge the patient at the TM80. Admitting a Patient After discharging the current patient, you can admit a new patient by pressing the key.
  • Page 59: Changing The Paced Status

    Patient Management Changing Patient Information NOTE • When the TM80 is connected to the CMS, the patient category at the CMS is updated if the patient category is changed at the TM80. Refer to BeneVision Central Monitoring System Operator’s Manual for details. 5.3.2 Changing the Paced Status It is important to correctly set the patient’s paced status before patient monitoring.
  • Page 60: Changing The Department Name, Room Number, And Bed Number

    Changing Patient Information Patient Management WARNING • For non-paced patients, you must set Paced to No. 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.
  • Page 61: Entering The Standby Mode

    Patient Management Entering the Standby Mode NOTE • When Department and Bed No./Room No. are set to Unfixed, the depart- ment name, room number, and bed number of the TM80 cannot be changed at the CMS. Entering the Standby Mode NOTE •...
  • Page 62: Discharging The Patient

    Discharging the Patient Patient Management Discharging the Patient Discharging the patient will stop monitoring at the TM80 and CMS. After discharging the patient, the patient’s configuration is cleared at the TM80. The TM80 can admit next new patient by applying the user configuration. If the TM80 does not save the user configura- tion, it will apply the factory configuration for the new patient.
  • Page 63: Alarms

    Alarms Introduction.......................6-2 Alarm Safety Information..................6-2 Understanding the Alarms ...................6-3 Viewing Alarms......................6-5 Changing Alarm Settings..................6-6 Pausing Alarms ......................6-8 Resetting Alarms ......................6-9 Latching Alarms......................6-10 Actions When an Alarm Occurs ................6-10 TM80 Telemetry Monitor Operator’s Manual 6 - 1...
  • Page 64: Introduction

    Introduction Alarms Introduction This chapter describes alarm functions and alarm settings. Alarm Safety Information WARNING • A potential hazard can exist if different alarm presets and default con- figuration settings are used for the same or similar equipment in the same care area.
  • Page 65: Understanding The Alarms

    Alarms Understanding the Alarms Understanding the Alarms 6.3.1 Alarm Categories The TM80’s alarms can be classified into two categories: physiological alarms and techni- cal alarms ■ Physiological alarms, also called patient status alarms, are triggered by a monitored parameter value that violates set alarm limits or an abnormal patient condition.
  • Page 66 Understanding the Alarms Alarms Medium High Priority Priority Alarm Indicator Message Comments Priority Alarm Alarm Alarm Audible Repeat pattern Repeat pat- Single beep None None tern of triple tone of triple +dou- beeps ble+ triple pattern +double beeps Mode 1 Repeat pattern Repeat pat- Low-...
  • Page 67: Alarm Status Symbols

    Alarms Viewing Alarms NOTE • When multiple alarms of the same priority levels occur simultaneously, all the alarm messages are displayed cyclically. • Some physiological alarms, such as Asystole, are exclusive. They have identical alarm tones and alarm lights with normal high level physiolog- ical alarms, but their alarm messages are displayed exclusively.
  • Page 68: Changing Alarm Settings

    Changing Alarm Settings Alarms Changing Alarm Settings 6.5.1 Changing Alarm Properties You can change alarm properties for parameters collectively or individually. To change alarm properties, follow this procedure: Enter the Alarm Limit menu in either of the following ways: ◆ key to enter the main menu →...
  • Page 69 Alarms Changing Alarm Settings To initiate auto alarm limits, follow this procedure: In the main menu, tap Alarms. Tap Alarm Limits. In the Setup section, tap Auto Limits. In the dialog that pops up, tap OK. Then the TM80 will automatically calculate alarm limits based on the latest measured values.
  • Page 70: Restoring Default Alarm Settings

    Pausing Alarms Alarms 6.5.4 Restoring Default Alarm Settings To restore default alarm settings, follow this procedure: In the main menu, tap Alarms. Tap Alarm Limits. In the Setup section, tap Defaults. In the dialog that pops up, tap OK. Pausing Alarms When an alarm occurs, follow this procedure to pause the alarm system.
  • Page 71: Resetting Alarms

    Alarms Resetting Alarms Resetting Alarms You can acknowledge the on-going alarms by resetting alarms. After being reset, the alarm system can respond to a subsequent alarm condition. When an alarm occurs, follow this procedure to reset the TM80’s alarm system. Press the key to enter the main menu.
  • Page 72: Latching Alarms

    Latching Alarms Alarms For some technical alarms, the symbol is displayed in the upper right corner ■ of the main screen. For details about the indications of technical alarms when the alarm system is reset, refer to "Technical Alarm Messages at the TM80" on page 15 - 7. NOTE •...
  • Page 73: Monitoring Ecg, Arrhythmia, St And Qt

    Monitoring ECG, Arrhythmia, ST and QT Introduction.......................7-2 ECG Safety Information..................7-2 Preparation for Monitoring ECG .................7-3 Changing ECG Settings..................7-13 Configuring the HR Alarm Source..............7-17 Understanding the ECG Display .................7-18 Arrhythmia Monitoring..................7-20 QT/QTc Interval Monitoring .................7-33 Relearning ........................7-35 TM80 Telemetry Monitor Operator’s Manual 7 - 1...
  • Page 74: Introduction

    Introduction Monitoring ECG, Arrhythmia, ST and QT Introduction The electrocardiogram (ECG) measures the electrical activity of the heart and displays it on the TM80 as waveforms and numerics. ECG monitoring provides 3-, 5-, and 6-lead ECG monitoring, ST-segment analysis, arrhythmia analysis, and QT/QTc measurements. Operations such as configuring the QRS threshold, adjusting the ST point/ISO point/J point, configuring the ST template/QT template are performed at the CMS.
  • Page 75: Preparation For Monitoring Ecg

    Monitoring ECG, Arrhythmia, ST and QT Preparation for Monitoring ECG NOTE • After defibrillation, the waveform recovers within 10 seconds applied in accordance with the manufacturer’s instructions for use. 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.
  • Page 76 Preparation for Monitoring ECG Monitoring ECG, Arrhythmia, ST and QT NOTE • 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.
  • Page 77: Configuring The Ecg Lead Labeling

    Monitoring ECG, Arrhythmia, ST and QT Preparation for Monitoring ECG 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 •...
  • Page 78: Placing The Electrodes

    Preparation for Monitoring ECG Monitoring ECG, Arrhythmia, ST and QT 7.3.3.2 Configuring the ECG Lead Labeling and Cable Type To configure the ECG lead labeling and cable type, follow this procedure: Press the key to enter the main menu. Tap Maintenance, enter the passcode, and then tap Accept. Tap General.
  • Page 79 Monitoring ECG, Arrhythmia, ST and QT Preparation for Monitoring ECG Electrode Placement RA (white) R (red) At the patient's 2nd ICS mid- clavicular line to the right of the sternum. LA (black) L (yellow) At the patient's 2nd ICS midclavicular line to the left of the sternum.
  • Page 80 Preparation for Monitoring ECG Monitoring ECG, Arrhythmia, ST and QT Electrode Placement LL (red) F (green) On the patient’s lower left chest wall within the ribcage frame. RL (green) N (black) On the patient’s lower right abdomen within the ribcage frame.
  • Page 81 Monitoring ECG, Arrhythmia, ST and QT Preparation for Monitoring ECG Electrode Placement RA (white) R (red) At the patient's 2nd ICS mid- clavicular line to the right of the sternum. LA (black) L (yellow) At the patient's 2nd ICS midclavicular line to the left of the sternum.
  • Page 82 Preparation for Monitoring ECG Monitoring ECG, Arrhythmia, ST and QT 7.3.4.4 Lead Placement: For Pacemaker Patients The recommended lead placement for monitoring a pacemaker patient is as follows. Pacemaker RA (R) LA (L) LL (F) 3-wire lead placement for a pacemaker patient (AHA)/(IEC) Pacemaker RA (R) LA (L)
  • Page 83: Checking The Lead Placement

    Monitoring ECG, Arrhythmia, ST and QT Preparation for Monitoring ECG Pacemaker RA (R) LA (L) V6 (C6) V5 (C5) V1 (C1) V4 (C4) LL (F) RL (N) V2 (C2) V3 (C3) 6-wire Lead Placement for a Pacemaker Patient (AHA)/(IEC) A pacemaker patient usually requires a different electrode patch placement configura- tion than a non-pacemaker patient.
  • Page 84: Checking The Paced Status

    Preparation for Monitoring ECG Monitoring ECG, Arrhythmia, ST and QT 7.3.5.2 Understanding the Lead Placement Instructions The Lead Placement window indicates the lead status. Information bar Lead on indicator Lead off indicator Example lead placement window When any of the leads are off, the indications are as follows: ■...
  • Page 85: Maintaining Quality Ecg Signal

    Monitoring ECG, Arrhythmia, ST and QT Changing ECG Settings 7.3.7 Maintaining Quality ECG Signal Regardless of patient age, electrodes should be replaced at least every 24 hours to maintain quality signals during long-term monitoring. Over the course of 24 hours, the electrode gel will start to dry out and the adhesive will age.
  • Page 86: Ecg Leadwire Types

    Changing ECG Settings Monitoring ECG, Arrhythmia, ST and QT Options Description Settings* Smart Lead (Monitored Refer to "ECG Leadwire Types" on page 7 - 14 for details. Lead) Filter Selects the ECG filter. Monitor, ST ■ Monitor Used under normal measurement conditions.
  • Page 87: Configuring Ecg Waveforms

    Monitoring ECG, Arrhythmia, ST and QT Changing ECG Settings 7.4.4 Configuring ECG Waveforms To configure ECG waveforms, follow this procedure: In the Waveform section of the ECG menu, select the options described in the fol- lowing table. Options Description Settings* All Lead Size Selects the waveform size for all the leads.
  • Page 88: Configuring The Ecg Waveform Size

    Changing ECG Settings Monitoring ECG, Arrhythmia, ST and QT Options Description Settings* Pacer Reject Selects whether or not to reject the pace On, Off pulses. The factory default settings are in bold. Tap the icon to exit the ECG menu. NOTE •...
  • Page 89: Configuring The Notch Filter

    Monitoring ECG, Arrhythmia, ST and QT Configuring the HR Alarm Source Options Description Settings* HR/PR Configures whether to trig- On, Off ger a HR/PR high or low alarm. Alarm limit range: 16 bpm to 299 bpm; the step is 1bpm. The default alarm high limit is 120 for adult and is 160 for pediatric.
  • Page 90: Understanding The Ecg Display

    Understanding the ECG Display Monitoring ECG, Arrhythmia, ST and QT ◆ Both: both HR and PR are used as the alarm source for HR/PR. NOTE • When Alarm Source is set to HR, systole beep comes from heart beat. When Alarm Source is set to PR, systole beep comes from pulse rate. Understanding the ECG Display 7.6.1 HR Digital Area...
  • Page 91: About The Hr Digital Area

    Monitoring ECG, Arrhythmia, ST and QT Understanding the ECG Display 7.6.2 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. ■...
  • Page 92: Arrhythmia Monitoring

    Arrhythmia Monitoring Monitoring ECG, Arrhythmia, ST and QT Arrhythmia Monitoring Arrhythmia monitoring is intended for adult and pediatric patients. 7.7.1 Arrhythmia Safety Information WARNING • Heart rate reading may be affected by cardiac arrhythmias. Do not rely entirely on heart rate alarms when monitoring patients with arrhythmia. Always keep these patients under close surveillance.
  • Page 93: Arrhythmia Events

    Monitoring ECG, Arrhythmia, ST and QT Arrhythmia Monitoring 7.7.2 Arrhythmia Events This section lists all arrhythmia events and their criteria. 7.7.2.1 Lethal Arrhythmia Events Arrhythmia message Description Asystole No QRS complex detected within the set time interval in the absence of ventricular fibrillation or chaotic signal.
  • Page 94: Changing Arrhythmia Alarm Settings

    Arrhythmia Monitoring Monitoring ECG, Arrhythmia, ST and QT Pacer Not Capture No QRS complex detected for 300 ms following a pace pulse (for paced patients only). Pacer Not Pacing No pace pulse detected for 1.75 x average R-to-R intervals following a QRS complex (for paced patients only).
  • Page 95 Monitoring ECG, Arrhythmia, ST and QT Arrhythmia Monitoring All Off switches off all arrhythmia alarms. This button becomes inactive when Lethal Arrhy Alarms Off is disabled in the System Setup menu of the CMS. Lethals Only: switches on all the lethal arrhythmia alarms only. Other types of arrhythmia alarms are off.
  • Page 96 Arrhythmia Monitoring Monitoring ECG, Arrhythmia, ST and QT Options Description Settings* Vent Brady Configures arrhyth- On, Off mia alarms. V-Brady PVCs:3 beats to 99 beats; the default is 5 beats. V-Brady Rate: 15 bpm to 60 bpm; the default is 40 bpm. Alarm priority: High Extreme Tachy On, Off...
  • Page 97 Monitoring ECG, Arrhythmia, ST and QT Arrhythmia Monitoring Options Description Settings* Bigeminy Configures arrhyth- On, Off mia alarms. Alarm priority: Prompt, Low, Med, High Trigeminy On, Off Alarm priority: Prompt, Low, Med, High Tachy On, Off 60 bpm to 299 bpm; the default Tachy threshold is consistent with the HR alarm high limit.
  • Page 98 Arrhythmia Monitoring Monitoring ECG, Arrhythmia, ST and QT Options Description Settings* Irr Rhythm Configures arrhyth- On, Off mia alarms. AF/Irr Rhy End Time: 0 min, 1 min, 2 min, 3 min, 4 min, 5 min, 10 min, 15 min, 30 min Alarm priority: Prompt, Low A-Fib On, Off...
  • Page 99: Intelligent Arrhythmia Alarm

    Monitoring ECG, Arrhythmia, ST and QT Arrhythmia Monitoring NOTE • If any of the lethal arrhythmia alarms is switched off, the ECG waveform area at the TM80 displays the “Lethal Arrhys Off” message. The ECG waveform area on the screen of the CMS displays Asystole, V-Fib/V-Tach, or V-Tach Off depending on the actual lethal arrhythmia alarm.
  • Page 100 Arrhythmia Monitoring Monitoring ECG, Arrhythmia, ST and QT Asystole V-Fib/V-Tach V-Tach Vent Brady Extreme Tachy Extreme Brady Beat Detection PVC Alarm Chain Rate Alarm Chain A-Fib Alarm Chain Alarm Chain A-Fib/ Nonsus V-Tach Pauses/min Tachy/Brady A-Fib End HR High / Irr Rhythm/ Vent Rhythm Pause...
  • Page 101: Understanding The Arrhythmia Display

    Monitoring ECG, Arrhythmia, ST and QT ST Segment Monitoring 7.7.4.3 Arrhythmia Alarm Refractory Period For the following eight alarms in medium priority chain, there is a 30-second refractory period. That is to say, if the same alarm is not presented within 30 seconds after the pre- vious alarm disappears.
  • Page 102: St Safety Information

    ST Segment Monitoring Monitoring ECG, Arrhythmia, ST and QT 7.8.1 ST Safety Information WARNING • ST values may be affected by such factors as some drugs or metabolic and conduction disturbances. • When the TM80 is connected to the CMS, the CMS provides information regarding changes in ST deviation levels.
  • Page 103: Configuring St Alarm Settings

    Monitoring ECG, Arrhythmia, ST and QT ST Segment Monitoring This example shows the ST digital area when the 6-lead ECG leadwires are used. Your screen may look slightly different: Parameter label ST alarm off symbol Lead label ST unit ST numerics: a positive value indicates ST segment elevation, and a negative value indicates ST segment depression.
  • Page 104 ST Segment Monitoring Monitoring ECG, Arrhythmia, ST and QT Options Description Settings* ST-I, These options are displayed On, Off when ST Alarm Mode is set to ST-II, Absolute. Alarm high limit range: ST-III, The lead label behind ST is con- 0.2 mV to 2.0 mV;...
  • Page 105: Qt/Qtc Interval Monitoring

    Monitoring ECG, Arrhythmia, ST and QT QT/QTc Interval Monitoring QT/QTc Interval Monitoring The QT interval is defined as the time between the beginning of the Q-wave and the end of the T-wave. It measures the total duration of ventricular depolarization (QRS duration) and repolarization (ST-T).
  • Page 106: Enabling Qt/Qtc Monitoring

    QT/QTc Interval Monitoring Monitoring ECG, Arrhythmia, ST and QT 7.9.2 Enabling QT/QTc Monitoring The QT monitoring function is disabled by default. Before you start QT monitoring, enable the QT function. To do so, follow this procedure: On the main screen, tap the HR digital area or ECG waveform area to enter the ECG menu.
  • Page 107: Relearning

    Monitoring ECG, Arrhythmia, ST and QT Relearning Options Description Settings* Configures whether to trigger On, Off the QTc alarm. Alarm high limit range: 200 ms to 800ms; the step is 1ms. The default is 500 for adult and the default is 480 for pediatric.
  • Page 108: Automatically Initiating An Ecg Relearning

    Relearning Monitoring ECG, Arrhythmia, ST and QT 7.10.1 Automatically Initiating an ECG Relearning Auto arrhythmia relearning is initiated in the following situation: ■ The ECG lead type or lead label is changed. ■ ECG leads are off and are not reconnected within 60 seconds. ■...
  • Page 109: Monitoring Respiration (Resp) (Optional)

    Monitoring Respiration (Resp) (Optional) Introduction.......................8-2 Resp Safety Information ..................8-2 Preparation for Monitoring Resp................8-3 Changing Resp Settings ..................8-4 Understanding the Resp Display................8-7 TM80 Telemetry Monitor Operator’s Manual 8 - 1...
  • Page 110: Introduction

    Introduction Monitoring Respiration (Resp) (Optional) Introduction Impedance respiration is measured across the thorax. When the patient is breathing or ventilated, the volume of air changes in the lungs, resulting in impedance changes between the electrodes. Respiration rate (RR) is calculated from these impedance changes, and a respiration waveform appears on the screen.
  • Page 111: Preparation For Monitoring Resp

    Monitoring Respiration (Resp) (Optional) Preparation for Monitoring Resp Preparation for Monitoring Resp 8.3.1 Preparing the Patient’s Skin To prepare the patient’s skin, follow this procedure: Shave the chest hair from the electrode sites in a circular area with a diameter of 2 to 4 inches.
  • Page 112: Changing Resp Settings

    Changing Resp Settings Monitoring Respiration (Resp) (Optional) CAUTION • Correct electrodes placement can help to reduce cardiac overlay: avoid the liver area and the ventricles of the heart in the line between the respiratory electrodes. This is particularly important for neonates. •...
  • Page 113: Entering The Resp Menu

    Monitoring Respiration (Resp) (Optional) Changing Resp Settings When Resp is enabled, the Resp digital data and waveform are displayed on the main screen. Besides, the Resp option is displayed in the list of parameters in the Setup section of the Parameter Setup menu. 8.4.2 Entering the Resp Menu When the Resp functionality is enabled, you can enter the Resp menu in either of the fol-...
  • Page 114: Configuring The Resp Waveform

    Changing Resp Settings Monitoring Respiration (Resp) (Optional) 8.4.4 Configuring the Resp Waveform To configure the Resp waveform, follow this procedure: In the Waveform section of theResp menu, select the options described in the fol- lowing table. Options Description Settings* Gain Selects the waveform size.
  • Page 115: Understanding The Resp Display

    Monitoring Respiration (Resp) (Optional) Understanding the Resp Display Options Description Settings* No Chest Movement The TM80 will trigger the “No Chest Movement” Alarm Priority: High alarm if the patient has stopped breathing for longer than the set apnea time. This option defaults to be switched on.
  • Page 116: Resp Waveform Area

    Understanding the Resp Display Monitoring Respiration (Resp) (Optional) 8.5.3 Resp Waveform Area Resp lead label Resp waveform Resp waveform gain 8.5.4 About the Resp Waveform Area ■ The Resp waveform, lead label, and waveform gain display in the configured Resp color.
  • Page 117 Monitoring Pulse Oxygen Saturation (SpO ) (Optional) Introduction.......................9-2 Measurement Limitations..................9-2 Safety..........................9-3 Connecting the SpO2 Module ................9-4 Changing the SpO2 Settings ................9-5 SpO2 Measurement ....................9-10 Understanding the SpO2 Display ..............9-11 Masimo Information ....................9-13 Nellcor Information....................9-14 TM80 Telemetry Monitor Operator’s Manual 9 - 1...
  • Page 118: Monitoring Pulse Oxygen Saturation (Spo2) (Optional)

    Introduction Monitoring Pulse Oxygen Saturation (SpO2) (Optional) Introduction Pulse Oxygen Saturation (SpO ) 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 tis- sue and is converted into electrical signals by the photo detector in the probe.
  • Page 119: Safety

    Monitoring Pulse Oxygen Saturation (SpO2) (Optional) Safety ■ 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. Safety WARNING • Only use SpO sensors specified in this manual.
  • Page 120: Connecting The Spo2 Module

    Connecting the SpO2 Module Monitoring Pulse Oxygen Saturation (SpO2) (Optional) Connecting the SpO Module Connect the SpO module to the TM80. The TM80 can auto detect the SpO module type when the SpO module is connected. module sensor connector sensor Connecting the Masimo SpO module 9 - 4...
  • Page 121 Monitoring Pulse Oxygen Saturation (SpO2) (Optional) Changing the SpO2 Settings module sensor connector sensor Connecting the Nellcor SpO module Changing the SpO Settings You can change the SpO settings from the SpO menu. 9.5.1 Configuring the SpO Setup Enter the SpO menu in either of the following ways: ■...
  • Page 122: Changing The Spo2 Settings

    Changing the SpO2 Settings Monitoring Pulse Oxygen Saturation (SpO2) (Optional) In the Setup section of the SpO menu, select the options described in the follow- ing table. Options Description Settings* Display PI Configures whether or not to show the perfu- On, Off sion index (PI) value in the digital area.
  • Page 123 Monitoring Pulse Oxygen Saturation (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 124 Changing the SpO2 Settings Monitoring Pulse Oxygen Saturation (SpO2) (Optional) 9.5.2 Configuring the SpO Waveform In the Waveform section of the SpO menu, select the options described in the following table. Options Description Settings* Speed Selects the SpO pleth waveform speed. 6.25 mm/s, 12.5 mm/s, 25 mm/s Display SIQ...
  • Page 125 Monitoring Pulse Oxygen Saturation (SpO2) (Optional) Changing the SpO2 Settings Options Description Settings* Alarm Setup Configures whether to switch on SpO and SpO For SpO Desat alarms. SpO and Desat default to be Alarm switch: On, Off switched on. After tapping SpO or Desat you can configure Alarm limit range: alarm limits and alarm priority.
  • Page 126: Spo2 Measurement

    SpO2 Measurement Monitoring Pulse Oxygen Saturation (SpO2) (Optional) Measurement 9.6.1 Identifying SpO Modules To identify which SpO module you are using, see the company logo on the SpO mod- ule. ■ Masimo SpO module: purple, with a logo of Masimo SET. ■...
  • Page 127: Understanding The Spo2 Display

    Monitoring Pulse Oxygen Saturation (SpO2) (Optional) Understanding the SpO2 Display CAUTION • Many patients suffer from poor peripheral perfusion due to hypother- mia, hypovolemia, severe vasoconstriction, reduced cardiac output, etc. These symptoms may cause a loss in vital sign readings. Understanding the SpO Display 9.7.1...
  • Page 128: Spo2 Waveform Area

    Understanding the SpO2 Display Monitoring Pulse Oxygen Saturation (SpO2) (Optional) Nellcor SpO digital area 9.7.2 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 129: Masimo Information

    Monitoring Pulse Oxygen Saturation (SpO2) (Optional) Masimo Information 9.7.4 About the SpO Waveform Area ■ Displays in the configured SpO color. ■ Provides scrolling, real-time waveform data. ■ Scrolls the waveform in the configured sweep speed. ■ Automatically scales the SpO waveform data area to maximize the vertical height of the Pleth waveform for the data range.
  • Page 130: Nellcor Information

    Nellcor Information Monitoring Pulse Oxygen Saturation (SpO2) (Optional) Nellcor Information Nellcor Patents This posting serves as notice under 35 U.S.C.§287(a) for Covidien patents: http:// www.covidien.com/patents. No Implied License Possession or purchase of this device does not convey any express or implied license to use the device with unauthorized replacement parts which would, alone, or in combina- tion with this device, fall within the scope of one or more of the patents relating to this device.
  • Page 131 Monitoring Noninvasive Blood Pressure (NIBP) (Optional) Pairing Introduction....................10-2 Pairing a TM80 with a BP10 ..................10-2 Unpairing the TM80 with the BP10 ..............10-4 Screen Display after Pairing a TM80 with a BP10 .........10-6 Interactions after Pairing a TM80 with a BP10..........10-7 TM80 Telemetry Monitor Operator’s Manual 10 - 1...
  • Page 132: Monitoring Noninvasive Blood Pressure (Nibp) (Optional)

    This measurement can be used for adult and pediatric patients. You can connect a TM80 to a BP10 via Mindray Patient Area Network (abbreviated as MPAN). The process of establishing connection between the TM80 and the BP10 is called “pairing”.
  • Page 133: System Responses After Successful Pairing

    Monitoring Noninvasive Blood Pressure (NIBP) (Optional) Pairing a TM80 with a BP10 WARNING • Before pairing a BP10 with a new TM80, unpair it with the current TM80 first. • Do not pair a TM80 with an undesired BP10. If a TM80 is paired with an undesired BP10, the patient category may be not applicable for the patient and the measured NIBP data may be incorrect.
  • Page 134: Unpairing The Tm80 With The Bp10

    Unpairing the TM80 with the BP10 Monitoring Noninvasive Blood Pressure (NIBP) (Optional) ◆ If neither Yes nor No is selected, the wireless setup confirmation message will disappear in three minutes. Besides, the “Pairing failure” message will be displayed in the prompt message area of the TM80. The “MPAN Disconnected”...
  • Page 135: Unpairing Via The Bp10

    Monitoring Noninvasive Blood Pressure (NIBP) (Optional) Unpairing the TM80 with the BP10 When the TM80 is unpaired with the BP10 successfully: ■ The status of the BP10 unpaired will be displayed as Disconnect on the list of Devices at the TM80. ■...
  • Page 136: Screen Display After Pairing A Tm80 With A Bp10

    Screen Display after Pairing a TM80 with a BP10 Monitoring Noninvasive Blood Pressure (NIBP) (Optional) CAUTION • Before moving a TM80 or BP10 to another area, unpair them first. • Before admitting a new patient at a BP10, you need to unpair it with a TM80 first.
  • Page 137: Interactions After Pairing A Tm80 With A Bp10

    Monitoring Noninvasive Blood Pressure (NIBP) (Optional) Interactions after Pairing a TM80 with a BP10 10.5 Interactions after Pairing a TM80 with a BP10 10.5.1 Overview of Interactions Once a TM80 is paired successfully with a BP10, the interactions proceed as shown below.
  • Page 138: Configuring Nibp Settings

    Interactions after Pairing a TM80 with a BP10 Monitoring Noninvasive Blood Pressure (NIBP) (Optional) 10.5.3 Configuring NIBP Settings To configure NIBP settings, follow this procedure: In the Setup section of the NIBP menu, select the options described in the follow- ing table.
  • Page 139 Monitoring Noninvasive Blood Pressure (NIBP) (Optional) Interactions after Pairing a TM80 with a BP10 Options Description Settings* Configures whether to trigger On, Off the NIBP diastolic pressure alarm. Alarm limit range: For adult: 11 mmHg to 209 mmHg; the default alarm high limit is 90 and the default alarm low limit is 50.
  • Page 140 Interactions after Pairing a TM80 with a BP10 Monitoring Noninvasive Blood Pressure (NIBP) (Optional) Options Description Settings* Configures whether to trigger On, Off Extreme the extreme NIBP diastolic pressure alarm. Alarm limit range: For adult: 10 mmHg to 210 mmHg; the default alarm high limit is 105 and the default alarm low limit is 35.
  • Page 141: Review

    Review Introduction.......................11-2 Tabular Trends Review Page.................11-2 Events Review Page ....................11-5 TM80 Telemetry Monitor Operator's Manual 11 - 1...
  • Page 142: Introduction

    Introduction Review 11.1 Introduction You can review patients’ history data on the tabular trends review page and the events review page. 11.2 Tabular Trends Review Page The tabular trends review page displays trend data in a tabular form. 11.2.1 Entering the Tabular Trends Review Page Enter the tabular trends review page in either of the following ways.
  • Page 143 Review Tabular Trends Review Page Current system date and trend data time. The interval of the trend data time is dependent on the option selected for Interval. Digital area: displays numeric values at the cursor indicated time. The background color of numeric values indicates the alarm priority. ◆...
  • Page 144: Example Tabular Trends Data Search Page

    Tabular Trends Review Page Review Next event button: tapping this button locates the next event. Previous event button: tapping this button locates the previous event. Interval setup button: tapping this button opens the Interval menu. For more information regarding this menu, refer to "Changing the Resolution of Trend Data"...
  • Page 145: Changing The Resolution Of Trend Data

    Review Events Review Page 11.2.4 Changing the Resolution of Trend Data Enter the tabular trends review page. Tap Interval in the lower left corner of the review page. Tap Interval. Select the desired option. ◆ 5 s or 30 s: select to view up to 4 hours of tabular trends at an interval of 5 seconds or 30 seconds.
  • Page 146: Example Events Review Page

    Events Review Page Review Option 2: Tap the Events button in the upper right corner of the tabular trends review page. NOTE • Alarms are saved as events and will be maintained if the equipment is powered down. The time of equipment power down is not recorded as an event and cannot be reviewed.
  • Page 147: Example Event Details Page

    Review Events Review Page ◆ Parameter value at the event trigger time. HR value is displayed when a physiological alarm is triggered. ◆ Different color blocks are displayed on the left of each event to indicate dif- ferent event types. For the meaning of each color block, refer to "Example Tabular Trends Review Page"...
  • Page 148 Events Review Page Review All the measurement numerics at the event trigger time are displayed at the bottom of the event details page. You can view these numerics by swiping your finger at the bot- tom of the main screen. The background color of numerics indicates the alarm priority. ■...
  • Page 149: Configuring The Tm80

    Configuring the TM80 Introduction.......................12-2 Entering the Maintenance menu ...............12-2 Configuring the General Menu................12-2 Configuring the Alarms Menu................12-4 Quick Keys Menu......................12-6 Configuring the Network Menu .................12-7 Configuring the Defaults Menu................12-14 Screen Lock Menu ....................12-15 Changing the Passwords..................12-16 Changing the Device Name .................12-17 Setting CMS Disconnect Alarm................12-17 Demo Mode .......................12-18 Service Menu......................12-18...
  • Page 150: Introduction

    Introduction Configuring the TM80 12.1 Introduction The 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 passcode. 12.2 Entering the Maintenance menu In the main menu, tap Maintenance.
  • Page 151: Configuring Device Location

    The factory default settings are in bold. Tap the icon to exit the General menu. NOTE • Mindray recommends the same SpO tone mode be used for the device within a monitoring area. 12.3.1 Configuring Device Location You can change device location and set whether to allow modifying a department name, room number, and bed number in the Patient Info menu.
  • Page 152: Configuring The Alarms Menu

    Configuring the Alarms Menu Configuring the TM80 Select the desired option. ◆ Fixed: you cannot modify Room No. and Bed No. in the Patient Info menu. Room No. and Bed No. are the ones entered in the Room No. and Bed No. fields of the Device Location menu.
  • Page 153 Configuring the TM80 Configuring the Alarms Menu Section & Options Description Settings* Technical Alarm Priority ECG Lead Off Allows an authorized user to configure the Low, Medium, High alarm priority. Sensor Off Allows an authorized user to configure the Low, Medium, High alarm priority.
  • Page 154: Quick Keys Menu

    Quick Keys Menu Configuring the TM80 12.5 Quick Keys Menu 12.5.1 Changing the Quick Keys In the Maintenance menu, tap Quick Keys. The Quick Keys configuration menu displays. From the quick keys area at the bottom of the screen, tap a quick key you want to configure.
  • Page 155: Deleting A Quick Key

    Configuring the TM80 Configuring the Network Menu Tap the icon to exit the Quick Keys menu. 12.5.2 Deleting a Quick Key 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.
  • Page 156: Configuring Ip Settings

    Mindray. • If a wirless network is provided by a hospital, it needs to be confirmed by authorized service personnel of Mindray. • The existence of obstacles (such as wall) will exert impact on data trans- ferring or even cause network interruption.
  • Page 157: Configuring Wlan Settings

    Configuring the TM80 Configuring the Network Menu Options Description Settings* IP Gateway Select to input the IP gateway address. Range: 1 to 255 for the number before the first decimal point 0 to 255 for the number after the first decimal point Factory default: 192.168.0.254 The factory default settings are in bold.
  • Page 158: Configuring Connection To The Cms

    Configuring the Network Menu Configuring the TM80 NOTE • We recommend that the latest WPA2-PSK or WPA2 CCKM security mode be used when the TM80 is in use. It provides a strong method of security when used with rotating strong passwords. Besides, it can provide opti- mal mobility and connectivity performance.
  • Page 159: Selecting A Cms

    Configuring the TM80 Configuring the Network Menu 12.6.3.2 Connecting the CMS in Unicast Mode In the Network menu, tap Connect CMS. Tap Connection Mode. Select Unicast. Configure the desired options. Options Description Settings* Edit CMS Configure the name and IP of the CMS you want to connect.
  • Page 160: Eap Certificate Management

    Configuring the Network Menu Configuring the TM80 ◆ When 5G is selected, tap AN Channels. Select the desired channels. NOTE • BGN Channels and AN Channels default to be blank. Channels need to be selected to improve roaming performance. 12.6.6 EAP Certificate Management You can import up to 10 certificates from a USB drive or delete certificates from the TM80.
  • Page 161 Configuring the TM80 Configuring the Network Menu USB drive used for upgrade Connect the MicroUSB Connect the USB drive to the power end to the TM80 adapter Power on the TM80. → → Press the key to enter the main menu tap Maintenance enter the →...
  • Page 162: Configuring The Defaults Menu

    Configuring the Defaults Menu Configuring the TM80 12.7 Configuring the Defaults Menu The Defaults menu allows an authorized user to manage the system configurations. In the Maintenance menu, tap Defaults. Select the options described in the following table. Options Description Save Departmental Defaults Allows an authorized user to save the current device settings for the selected patient category.
  • Page 163: Screen Lock Menu

    Configuring the TM80 Screen Lock Menu WARNING • Do not power off the devices during the download process. • symbol displays at the top of the screen while transferring a configuration. • When TM80 is connected to the CentralStation, Import Device Settings would not work.
  • Page 164: Setting The Screen Lock

    Changing the Passwords Configuring the TM80 Upon powering up, the main screen will be displayed after the new patient choice is made. Main Screen is accessible without passcode entry. The System Info menu is accessible by tapping the battery symbol on the main screen.
  • Page 165: 12.10 Changing The Device Name

    Configuring the TM80 Changing the Device Name Tap Service Password and follow the on-screen instructions to change the service password. Tap the icon to exit the Edit Passwords menu. 12.10 Changing the Device Name In the Maintenance menu, tap Device Name. Use the on-screen keyboard to input the device name.
  • Page 166: 12.12 Demo Mode

    Demo Mode Configuring the TM80 12.12 Demo Mode Allows an authorized user to choose a demonstration mode for in-servicing staff or test- ing product features. 12.13 Service Menu Allows an authorized user access to the passcode protected Service menu. 12 - 18 TM80 Telemetry Monitor Operator’s Manual...
  • Page 167 Monitoring with the TM80 at the CMS Introduction.......................13-2 Network Safety Information.................13-3 Adjusting the Minimum QRS Detection Threshold ........13-3 Setting the Analysis Leads ..................13-4 QT monitoring......................13-4 ST Monitoring......................13-7 Arrhythmia Monitoring..................13-11 Locating the TM80....................13-13 Sending a Notification to the TM80 ..............13-13 Triggering an Alarm Reminding Patients' Location........13-14 TM80 Telemetry Monitor Operator’s Manual 13 - 1...
  • Page 168: Introduction

    Introduction Monitoring with the TM80 at the CMS 13.1 Introduction This chapter only describes the operations that you need to perform at the CMS. For common operations such as how to set alarms and parameter settings at the CMS, refer to BeneVision Central Monitoring System Operator’s Manual.
  • Page 169: Network Safety Information

    13.2 Network Safety Information CAUTION • Wireless network designing, deploying, debugging, and maintenance should be executed by Mindray service personnel or authorized techni- cians. • Always set the wireless network according to local wireless regulations. • Keep network authentication information, for example password, safe, protecting the network from being accessed by unauthorized users.
  • Page 170: Qt Monitoring

    Setting the Analysis Leads Monitoring with the TM80 at the CMS CAUTION • The setting of QRS threshold can affect the sensitivity of arrhythmia, ST, QT/QTc detection, and heart rate calculation. • If QRS amplitude is low, the TM80 might not be able to calculate heart rate and false asystole may occur.
  • Page 171: Changing The Qtc Formula

    Monitoring with the TM80 at the CMS QT Monitoring 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- 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.
  • Page 172 QT Monitoring Monitoring with the TM80 at the CMS The current waveform and parameter values display in green. The template waveform and parameter values display in white. The Q and T points are marked with a vertical line. The ΔQTc value is equal to the current QTc value minus the template QTc value. In some conditions, no QT measurement can be calculated.
  • Page 173: St Monitoring

    Monitoring with the TM80 at the CMS ST Monitoring 13.5.2.2 Configuring the QT View To configure the QT view, follow this procedure: Enter QT View. Select the buttons described in the following table as desired. Buttons Description Settings* Left or right arrow Select the desired lead to display on the II, I, III, aVR, aVL, aVF, V QT View menu screen by selecting the left...
  • Page 174 ST Monitoring Monitoring with the TM80 at the CMS 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 175: Adjusting St Measurement Points

    Monitoring with the TM80 at the CMS ST Monitoring 13.6.1 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 176: Entering The St View

    ST Monitoring Monitoring with the TM80 at the CMS The height of gray bar indicates the baseline ST value and the green bar (cyan, yellow or red if an alarm occurs) indicates ΔST. 13.6.3 Entering the ST View The ST View shows a complete QRS segment for each ST lead. The color of current ST segments and ST values is consistent with the color of ECG waveforms, normally green.
  • Page 177: Arrhythmia Monitoring

    Monitoring with the TM80 at the CMS Arrhythmia Monitoring Set the desired items. Buttons Description Settings* Set Baseline Set an ST baseline when ST values become None stable. The ST template updated time displays at the bottom of the screen. Display/Hide Baseline Displays or hides the reference baseline.
  • Page 178: Configuring The Arrhythmia Shield Time

    Arrhythmia Monitoring Monitoring with the TM80 at the CMS If both V-Tach PVCs and V-Tach Rate are greater than or equal to the limits, a V-Tach alarm is generated. If consecutive PVCs is lower than the V-Tach PVCs limit (6) but greater than 2, and the Vent rate is greater or equal to the V-Tach Rate limit (130), a Nonsus V-Tach alarm is generated.
  • Page 179: Locating The Tm80

    Monitoring with the TM80 at the CMS Locating the TM80 13.8 Locating the TM80 If the AP information of the TM80 has been imported into the CentralStation, you can view device location information for TM80 telemetry monitors. For details on how to import AP information, see BeneVision Central Monitoring System Operator’s Manual.
  • Page 180: 13.10 Triggering An Alarm Reminding Patients' Location

    Triggering an Alarm Reminding Patients' Location Monitoring with the TM80 at the CMS 13.10 Triggering an Alarm Reminding Patients' Location You can enable the functionality of triggering an alarm when patients enter or move out of the restricted area at the CMS. After the functionality is enabled, when a patient enter or move out of the restricted area, the “Out of the allowed area ”...
  • Page 181: Battery

    Battery Introduction.......................14-2 Safety..........................14-2 Installing the Battery ....................14-4 Checking the Battery Charge Status ..............14-4 Removing the Battery ....................14-4 Charging the Rechargeable Lithium-ion Battery .........14-5 Storing the Batteries ....................14-6 Maintaining the Rechargeable Lithium-ion Battery........14-7 Disposing of the Batteries..................14-8 TM80 Telemetry Monitor Operator’s Manual 14 - 1...
  • Page 182: Introduction

    Introduction Battery 14.1 Introduction The TM80 can be powered by a lithium-ion rechargeable battery pack or AA batteries. This chapter provides instructions on how to use, maintain, and dispose of the batteries. 14.2 Safety WARNING • Keep the batteries out of children’s reach. •...
  • Page 183 Battery Safety WARNING • If a battery shows signs of damage or signs of leakage, replace it imme- diately. 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 184: Installing The Battery

    Installing the Battery Battery NOTE • When the TM80 is not powered off, if you remove batteries, patient data measured within one minute before the battery removal will be lost. 14.3 Installing the Battery Refer to "Installing the Batteries" on page 3 - 5 for details. 14.4 Checking the Battery Charge Status The battery symbol displaying on the top of main screen indicates the battery charge...
  • Page 185: Charging The Rechargeable Lithium-Ion Battery

    WARNING • Only use the specified central charger to charge to the lithium-ion bat- teries 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 186: Storing The Batteries

    Storing the Batteries Battery Use 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 BeneVision Central Charger Operator’s Manual (P/N: 046-007059-00). 14.7 Storing the Batteries 14.7.1 Storing Rechargeable Lithium-ion Batteries...
  • Page 187: Storing Aa Batteries

    Experience indicates that the incidence of failure may increase with battery ser- vice life due to the accumulated stresses of daily use. Therefore, Mindray strongly recom- mend that lithium-ion battery should be replaced after two years or 500 complete charge-discharge cycles.
  • Page 188: 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. 14.9 Disposing of the Batteries 14.9.1...
  • Page 189: Troubleshooting

    Troubleshooting General Problems.....................15-2 Physiological Alarm Messages at the TM80 ...........15-4 Technical Alarm Messages at the TM80 ............15-7 TM80 Telemetry Monitor Operator’s Manual 15 - 1...
  • Page 190: General Problems

    General Problems Troubleshooting 15.1 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. For methods to troubleshoot the central charger, refer to BeneVision Central Charger Operator’s Manual.
  • Page 191 Troubleshooting General Problems Symptom Possible cause Solution The TM80 cannot be The wireless access point (AP) in the Make sure that the AP is enabled and connected to the Cen- vicinity is not enabled. belongs to the Virtual LAN (VLAN) where the tral Station wirelessly TM80 is covered.
  • Page 192: Physiological Alarm Messages At The Tm80

    Physiological Alarm Messages at the TM80 Troubleshooting Symptom Possible cause Solution The TM80 and BP10 As there are many WiFi devices in Contact your service personnel. are prone to offline in this area, communication between certain area. the TM80 and BP10 is interfered seriously.
  • Page 193 Troubleshooting Physiological Alarm Messages at the TM80 Default Measurement Alarm message Alarm Possible cause Solution priority Asystole High The patient is in arrhyth- Check the patient’s con- mia. dition and the ECG con- nections. V-Fib/V-Tach V-Tach Vent Brady Extreme Tachy Extreme Brady R on T Med*...
  • Page 194 Physiological Alarm Messages at the TM80 Troubleshooting Default Measurement Alarm message Alarm Possible cause Solution priority Irr Rhythm End Prompt Irregular rhythm no lon- Check the patient’s con- ger detected for the dition and the ECG con- irregular rhythm end nections.
  • Page 195 Troubleshooting Physiological Alarm Messages at the TM80 Default Measurement Alarm message Alarm Possible cause Solution priority Resp RR High Med* RR value has risen above Check the patient’s con- the high alarm limit or dition and make sure fallen below the low that the patient cate- RR Low alarm limit.
  • Page 196: Technical Alarm Messages At The Tm80

    Technical Alarm Messages at the TM80 Troubleshooting Default Measurement Alarm message Alarm Possible cause Solution priority NIBP NIBP-S High The NIBP systolic Check the patient’s con- Extremely High pressure has risen above dition and check if the the extreme alarm high alarm limit settings are limit or fallen below the NIBP-S...
  • Page 197 Check for any possi- Noisy ble sources of signal noise around the cable and electrode, and check the patient for great motion. HR exceeds the measure- Contact Mindray or Over- ment limit. your service person- range nel. Prompt ECG learning is manually Learning or automatically trig- gered.
  • Page 198 Technical Alarm Messages at the TM80 Troubleshooting Default Alarm Alarm Measurement Alarm Possible cause Solution message Indication priority Low* The SpO sensor has Check the sensor application site and Sensor become detached from the sensor type, and the patient or the mod- make sure the sen- ule.
  • Page 199 2. Reposition the is too low. sensor if necessary. PR Over- The measured PR value Contact Mindray or range exceeds the measure- your service person- ment range. nel. NIBP NIBP Low The battery charge is low.
  • Page 200 Technical Alarm Messages at the TM80 Troubleshooting Default Alarm Alarm Measurement Alarm Possible cause Solution message Indication priority NIBP NIBP High Restart the BP10. An error occurred Module NIBP Error module. There is a problem with communication between the TM80 and BP10.
  • Page 201 Troubleshooting Technical Alarm Messages at the TM80 Default Alarm Alarm Measurement Alarm Possible cause Solution message Indication priority NIBP NIBP Cuff The NIBP airway may leak Verify that the or Air- air. cuff is prop- way Leak erly con- nected. 2.
  • Page 202 Technical Alarm Messages at the TM80 Troubleshooting Default Alarm Alarm Measurement Alarm Possible cause Solution message Indication priority Power Low Bat- The battery charge is low. Replace with new tery batteries. Critically High The battery charge is Low Bat- almost depleted. tery Battery The lithium-ion battery is...
  • Page 203 Troubleshooting Technical Alarm Messages at the TM80 This page intentionally left blank. TM80 Telemetry Monitor Operator’s Manual 15 - 15...
  • Page 204 Technical Alarm Messages at the TM80 Troubleshooting 15 - 16 TM80 Telemetry Monitor Operator’s Manual...
  • Page 205: Cleaning And Disinfecting

    Cleaning and Disinfecting Introduction.......................16-2 Safety Information....................16-2 Cleaning and Disinfecting the Equipment .............16-3 Cleaning and Disinfecting ECG Leadwires and SpO2 Sensors ....16-7 Cleaning and Disinfecting Other Parts.............16-8 Sterilization ........................16-9 Impact of Improper Cleaning or Disinfection..........16-9 TM80 Telemetry Monitor Operator’s Manual 16 - 1...
  • Page 206: Introduction

    • 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 hospital’s infection control officer or epidemiologist.
  • Page 207: Cleaning And Disinfecting The Equipment

    Cleaning and Disinfecting Cleaning and Disinfecting the Equipment 16.3 Cleaning and Disinfecting the Equipment 16.3.1 Approved Cleaning and Disinfecting Agents The following table lists approved cleaning and disinfecting agents: Product Name Product Type Active Ingredients Sodium hypochlorite bleach* Liquid Sodium hypochlorite bleach 10% Hydrogen peroxide* Hydrogen peroxide 3% Isopropanol*...
  • Page 208 Cleaning and Disinfecting the Equipment Cleaning and Disinfecting Product Name Product Type Active Ingredients ® Wipes Isopropyl Alcohol 58.6000%? Alpet D2 Surface Sanitizing Octyl Decyl Dimethyl Ammonium Wipes chloride 0.0075%, Dioctyl Dimethyl Ammonium Chloride 0.0030% ® Sodium Hypochlorite 0.65% Clorox Dispatch Hospital Cleaner Disinfectant Towels with Bleach...
  • Page 209: Cleaning The Equipment

    Cleaning and Disinfecting Cleaning and Disinfecting the Equipment NOTE • , all the listed cleaning and For equipment with the symbol disinfecting agents are available for use. For equipment without the , only the cleaning and disinfecting agents marked with “*” symbol are available for use.
  • Page 210 Cleaning and Disinfecting the Equipment Cleaning and Disinfecting To clean the equipment, follow this procedure: Shut down the device. Clean the display screen with wipes or a soft cloth moistened with one of the cleaning agents listed in "Approved Cleaning and Disinfecting Agents" on page 16 - 3 only.
  • Page 211: Disinfecting The Equipment

    Cleaning and Disinfecting Cleaning and Disinfecting ECG Leadwires and SpO2 Sensors 16.3.3 Disinfecting the Equipment Disinfect the equipment as required in your hospital’s servicing schedule using the disinfecting agents list in "Approved Cleaning and Disinfecting Agents" on page 16 - 3. Cleaning before disinfection is recommended.
  • Page 212: Cleaning And Disinfecting Other Parts

    Cleaning and Disinfecting Other Parts Cleaning and Disinfecting 16.5 Cleaning and Disinfecting Other Parts Other parts refer to the interior surface of lithium-ion battery pack or battery tray, the battery compartment, ECG connector, SpO connector, and SpO cable, as shown below. Clean or disinfect other parts only when needed or as required in your hospital’s servicing schedule.
  • Page 213: Sterilization

    Cleaning and Disinfecting Sterilization 16.6 Sterilization Sterilization is not recommended for this equipment, related products, accessories or supplies unless otherwise indicated in the instructions for use delivered with the products, accessories or supplies. 16.7 Impact of Improper Cleaning or Disinfection Using cleaning agents or disinfectants other than those recommended may have the following impact: ■...
  • Page 214 Impact of Improper Cleaning or Disinfection Cleaning and Disinfecting This page intentionally left blank. 16 - 10 TM80 Telemetry Monitor Operator’s Manual...
  • Page 215: Maintenance

    Maintenance Introduction.......................17-2 Safety..........................17-2 Regular Check ......................17-3 Maintenance and Testing Schedule ..............17-4 Power-on Test......................17-4 Verifying the ECG .....................17-5 NIBP Accuracy Test ....................17-5 NIBP Leakage Test....................17-5 Nurse Call Test ......................17-5 Electrical Safety Tests....................17-5 Battery Check ......................17-6 Viewing System Information ................17-6 TM80 Telemetry Monitor Operator’s Manual 17 - 1...
  • Page 216: Introduction

    • 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 ser- vice personnel or Mindray.
  • Page 217: Regular Check

    Maintenance Regular Check 17.3 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 funtion properly.
  • Page 218: Maintenance And Testing Schedule

    Maintenance and Testing Schedule Maintenance 17.4 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 219: Verifying The Ecg

    Maintenance Verifying the ECG 17.6 Verifying the ECG The ECG signal may be inaccurate due to hardware or software problems. As a result, the ECG wave amplitude becomes greater or smaller. To verify the ECG waveform amplitude: In the main menu, tap Parameter Setup. Tap ECG and set Filter to Monitor.
  • Page 220: 17.11 Battery Check

    Battery Check Maintenance 17.11 Battery Check For details about the battery charge check and maintenance, refer to "Maintaining the Rechargeable Lithium-ion Battery" on page 14 - 7. 17.12 Viewing System Information To view the system information of the TM80, such as battery, tap System Info from the main menu.
  • Page 221: Accessories

    Accessories ECG Accessories......................18-2 SpO2 Accessories .....................18-4 NIBP Accessories ......................18-5 Miscellaneous......................18-5 TM80 Telemetry Monitor Operator’s Manual 18 - 1...
  • Page 222: 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 223: Ecg Leadsets

    Accessories ECG Accessories 18.1.2 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" 115-032954-00 3-Lead, New Telemetry, Disp, AHA, Snap, 24"...
  • Page 224: Spo2 Accessories

    SpO2 Accessories Accessories 18.2 Accessories The SpO 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. 18.2.1 Masimo SpO Module Applicable Applicable Description property patient 009-004936-00 Masimo SpO2 module (SET uSpO2) Reusable...
  • Page 225: Nellcor Spo2 Module

    Accessories NIBP Accessories 18.2.3 Nellcor SpO Module Description Applicable property Applicable patient 115-054978-00 Nellcor SpO module Reusable Adult, Pediatric 18.2.4 Nellcor SpO Sensor Description Applicable property Applicable patient 9000-10-05161 Reusable SpO sensor, finger-clip Reusable Adult 9000-10-07308 Reusable Pediatric-Infant SpO2 sen- Reusable Pediatric sor with wraps, Ped/Infant...
  • Page 226 Miscellaneous Accessories Description 115-026852-00 Main unit of the central charger 18 - 6 TM80 Telemetry Monitor Operator’s Manual...
  • Page 227 Product Specifications Classifications......................A-2 Environmental Specifications................A-2 Power Supply Specifications................A-3 Physical Specifications ...................A-4 Hardware Specifications..................A-5 Data Storage ......................A-6 Wireless Specification.....................A-6 Measurement Specifications ................A-10 TM80 Telemetry Monitor Operator’s Manual A - 1...
  • Page 228: A Product Specifications

    Classifications Product Specifications This chapter provides specifications of the TM80 and central charger. For specifications of BP10, refer to BP10 NIBP Module Operator’s Manual (P/N: 046-011008-00). Classifications The device is classified as follows according to IEC60601-1: TM80: energized from an internal electrical power source. Type of protection against electrical shock Central Charger: class I.
  • Page 229: Power Supply Specifications

    Product Specifications Power Supply Specifications Power Supply Specifications A.3.1 TM80 The battery life listed below may be shortened by the following factors: ■ Wireless signal interference ■ Aging battery ■ Frequent operation of turning on/off the display ■ Wireless network coverage which does not meet the technical specifications in "Wireless Specification"...
  • Page 230: Central Charger

    Physical Specifications Product Specifications A.3.2 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 to 90% charge Charge time The charger automatically stops charging when the lithium-ion Overcharge protection function...
  • Page 231: Hardware Specifications

    Product Specifications Hardware Specifications Hardware Specifications A.5.1 TM80 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 232: Data Storage

    ■ Up to 200 events ■ Up to two-hour full disclosure waveforms of ECG I, II, III, and V/Va leads Wireless Specification A.7.1 Mindray Patient Area Network (MPAN) Specification A.7.1.1 Technical Specification Bluetooth low energy 4.0 Protocol standard GFSK Modulation mode...
  • Page 233 Product Specifications Wireless Specification A.7.1.2 Implemented Function This function is provided to transfer configuration information between the TM80 and to perform communication between a TM80 and a BP10. BP10 transmits NIBP parameters, status, and prompt messages to the TM80. The TM80 transmits control information and settings information to the BP10.
  • Page 234: Wi-Fi Specifciations

    Wireless Specification Product Specifications A.7.2 Wi-Fi Specifciations A.7.2.1 Technical Specifications IEEE 802.11 a/b/g/n/ac Protocol DSSS and OFDM Modulation mode 2412 MHz to 2472 MHz Operating frequency 5180 MHz to 5825 MHz IEEE 802.11 b/g/n (at 2.4G): 5 MHz Channel spacing IEEE802.11 a/n/ac (at 5G): 20 MHz IEEE 802.11b: 1M Mbps to 11M Mbps IEEE 802.11a/g: 6 M Mbps to 54M Mbps...
  • Page 235 Product Specifications Wireless Specification The probability for loss of application data within wireless net- Data integrity work should be less than 1000ppm(0.1%). Total delay of data transmission from the TM80 Telemetry Moni- Data latency tor to the CMS: ≤ 3 seconds. All communication data types shall have the same priority.
  • Page 236: Measurement Specifications

    Measurement Specifications Product Specifications Measurement Specifications A.8.1 Meet standards of IEC60601-2-27 Standard 3-lead: I, II, III 5-lead: I, II, III, aVR, aVL, aVF, V Leadset 6-lead: I, II, III, aVR, aVL, aVF, Va, Vb Automatic 3/5/6- lead recognition AHA, IEC ECG standard 6.25 mm/s, 12.5 mm/s, 25 mm/s Sweep speed...
  • Page 237 Product Specifications Measurement Specifications ≤ 10% (100 Ω load) Defibrillation energy absorption Pace Pulse Pace pulses meeting the following conditions are labelled with a PACE marker: Amplitude: ±2 mV to ±700 mV Pace pulse markers Width: 0.1 ms to 2 ms Rise time: 10 μs to 100 μs Amplitude: ≥...
  • Page 238 Measurement Specifications Product Specifications In 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 bpm Response to irregular rhythm Slow alternating ventricular bigeminy (3b): 60 ± 1 bpm Rapid alternating ventricular bigeminy (3c): 120 ±...
  • Page 239: Resp

    Product Specifications Measurement Specifications 200 ms to 800 ms: 1 ms QTc resolution Beyond this range: Not specified Adult: 15 bpm to 150 bpm QT-HR measurement range Pediatric: 15 bpm to 180 bpm A.8.2 Resp Resp Trans-thoracic impedance Technique Lead II Lead <300 μA RM, 32kHz (±10%) Respiration excitation waveform...
  • Page 240 Measurement Specifications Product Specifications A.8.3.1 Masimo SpO Module 1% to 100% Measurement range Resolution 70-100%: ±2.0% (measured without motion) Accuracy* 70-100%: ±3.0% (measured with motion) 1-69%: Not specified Pulse amplitude: > 0.02% Low Perfusion Conditions Light penetration: > 5% Accuracy: ±2% ≤2s Data update rate *SpO...
  • Page 241 Product Specifications Measurement Specifications 0.02% to 20% Measurement range 0.01, use three valid digits Least resolution Response Time ■ ≤ 25 s (PR 75 bpm, average time 8 s, no disturbance, SpO value rises from 50% to 100%) ■ ≤ 20 s (SpO value 98%, average time 8 s, no disturbance, PR value rises from 60 bpm to 150 bpm) A.8.3.2...
  • Page 242 Measurement Specifications Product Specifications DCI/DCIP A.8.3.3 Nellcor SpO Module 0% to 100% Measurement range Resolution 70-100%: ±2 ABS Accuracy 60-80%: ±3 ABS 0-59%: Not specified ≤2s Data update rate 20 bpm to 300 pm Measurement range 20 bpm to 250 bpm: ±3 bpm Accuracy 251 bpm to 300 bpm: Not specified A - 16...
  • Page 243 Product Specifications Measurement Specifications A.8.3.4 Fitting Curve for Nellcor SpO Sensors ■ Accuracy for Nellcor Sensors vs. Co-Oximeters (Arms) Range 100% to 70% 100% to 90% 89% to 80% 79% to 70% DS-100A 1.64% 1.16% 1.67% 2.25% D-YS, OXI-P/I 2.41% 1.38% 2.50% 3.60%...
  • Page 244 Measurement Specifications Product Specifications ■ Modified Bland-Altman for SpO -D-YS, OXI-P/I Sensors: (SpO - SaO ) vs. A - 18 TM80 Telemetry Monitor Operator’s Manual...
  • Page 245 TM80 Telemetry Monitor Operator’s Manual B - 1...
  • Page 246 The device meets the requirements of IEC 60601-1-2: 2014. WARNING • Use of accessories, transducers and cables other than those specified or provided by the manufacturer of this device could result in increased electromagnetic emissions or decreased electromagnetic immunity of this device and result in improper operation.
  • Page 247 RF emissions Class A The system is suitable for use in all establishments other than domestic and those directly connected to the public CISPR 11 low-voltage power supply network that supplies build- ings used for domestic purposes. Harmonic distortion Class A IEC 61000-3-2 Voltage fluctuations Compliance...
  • Page 248 If the system is operated within the electromagnetic environment listed in Table Guid- ance and declaration — electromagnetic immunity, the system will remain safe and pro- vide the following essential performance: ■ Operating mode ■ Accuracy ■ Function ■ Accessories identification ■...
  • Page 249 RATED power 30 A/m 30 A/m Power frequency magnetic fields frequency mag- should be at levels characteristic of a 50 Hz / 60 Hz 50 Hz / 60 Hz netic fields typical location in a typical commercial or hospital environment. IEC 61000-4-8 Note: U is the A.C.
  • Page 250 Guidance and Declaration - Electromagnetic Immunity The device is intended for use in the specified electromagnetic environment. The customer or the user of the device should assure that it is used in such an environment as described below. IEC 60601 Test Compliance Immunity test Electromagnetic environment - guidance...
  • Page 251 a The ISM (industrial, scientific, and medical) bands between 150 kHz and 80 MHz are 6.765 MHz to 6.795 MHz; 13.553 MHz to 13.567 MHz; 26.957 MHz to 27.283 MHz; and 40.66 MHz to 40.70 MHz. The amateur radio bands between 0,15 MHz and 80 MHz are 1,8 MHz to 2,0 MHz, 3,5 MHz to 4,0 MHz, 5,3 MHz to 5,4 MHz, 7 MHz to 7,3 MHz, 10,1 MHz to 10,15 MHz, 14 MHz to 14,2 MHz, 18,07 MHz to 18,17 MHz, 21,0 MHz to 21,4 MHz, 24,89 MHz to 24,99 MHz, 28,0 MHz to 29,7 MHz and 50,0 MHz to 54,0 MHz.
  • Page 252 This page intentionally left blank. B - 8 TM80 Telemetry Monitor Operator’s Manual...
  • Page 253: C Fcc Compliance

    FCC Compliance TM80 Telemetry Monitor Operator’s Manual C - 1...
  • Page 254 FCC Compliance The TM80 telemetry monitor complies with the requirements of FCC Part 95: 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.
  • Page 255 FCC Compliance RF parameter (Wi-Fi Module) (SX-SDMAC-2832S+) Type of Radio IEEE 802.11b/g/n (2.4G) IEEE 802.11a/n (5G) Modulation mode DSSS and OFDM OFDM Operating frequency 2412 MHz to 2472 MHz 5180 MHz to 5825 MHz Output power < 30 dBm (Peak Power) <...
  • Page 256 FCC Compliance This page intentionally left blank. C - 4 TM80 Telemetry Monitor Operator’s Manual...
  • Page 257: D Symbols And Abbreviations

    Symbols and Abbreviations Units..........................D-2 Symbols ........................D-3 Abbreviations ......................D-3 TM80 Telemetry Monitor Operator’s Manual D - 1...
  • Page 258: 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 259: 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 260 Abbreviations Symbols and Abbreviations electromagnetic compatibility 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...
  • Page 262 P/N: 046-012662-00(3.0)

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