BeneVision TMS60 Telemetry Monitoring System Operator’s Manual
Introduction © Copyright 2015 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. All rights reserved. For this Operator’s Manual, the issue date is 2015-06.
Intellectual Property Statement Introduction Intellectual Property Statement SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. (hereinafter called Mindray) owns the intellectual property rights to this Mindray product and this manual. This manual may refer to information protected by copyrights or patents and does not convey any license under the patent rights of Mindray, nor the rights of others. Mindray intends to maintain the contents of this manual as confidential information.
Introduction Warranty WARNING • • Only skilled/trained clinical professionals should operate this equipment. It is important for the hospital or organization that employs this equipment to carry out a reasonable service/maintenance plan. Neglect of this may result in machine breakdown or personal injury.
Company Contact 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. This warranty does not extend to: ■ Malfunction or damage caused by improper use or man-made failure.
Introduction Preface Fax: 0049-40-255726 Preface Manual Purpose This manual contains the instructions necessary to operate the product safely and in accordance with its function and intended use. Observance of this manual is a prerequisite for proper product performance and correct operation and ensures patient and operator safety. This manual is based on the maximum configuration and therefore some contents may not apply to your product. If you have any questions, please contact Mindray.
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Contents 1 Safety ........................................................................................................................................ 1 - 1 1.1 Safety Information ..................................................................................................................................... 1 - 2 1.1.1 Warnings ........................................................................................................................................ 1 - 3 1.1.2 Cautions ...............
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 ................................................
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 .......................................................
9.3.2 Waveform Setup ........................................................................................................................9 - 13 9.3.3 Other Settings ............................................................................................................................9 - 15 9.3.4 ECG Display .................................................................................................................................9 - 16 9.4 QT Monitoring ........................................
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 ...................
15.2.2 Masimo SpO2 Sensor ............................................................................................................15 - 4 15.2.3 Nonin SpO2 Module ..............................................................................................................15 - 4 15.2.4 Nonin SpO2 Sensor ................................................................................................................15 - 4 15.3 Miscellaneous ..................................................................
1 Safety Safety Information...................................................................................................1-2 Equipment Symbols................................................................................................
Safety Information 1.1 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 • 1-2 Provides application tips or other useful information to ensure that you get the most from your product.
Safety 1.1.1 Safety Information 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. Do not use this equipment in conjunction with Electro Surgical Unit (ESU).
Safety Information Safety WARNING • • • 1.1.2 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. Cautions CAUTION • • • • • • • • • 1-4 Do not let the display directly touch the patient when the display is on.
Safety Equipment Symbols CAUTION • • 1.1.3 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.
Equipment Symbols Safety Symbol MR Description Symbol Description MR Unsafe – do not subject to magnetic resonance imaging (MRI) IPX7 Protection against fluid ingress Interference may occur in the vicinity of equipment marked with this symbol General warning sign Refer to instruction manual/booklet The presence of this label indicates the machine was certified by ETL with the statement: Conforms to AAMI Std ES 60601-1, IEC 60601-1-6, IEC Std 60601-1-8, IEC Std 606012-27, IEC Std 60601-2-49, ISO
2 General Product Description Intended Use .............................................................................................................2-2 Applied Parts .............................................................................................................2-2 Key Features...............................................................................................................2-2 System Components ..................................................................................
Intended Use 2.1 General Product Description Intended Use The TMS60 transmitter is intended for use on Adult and Pediatric patients to monitor ECG and SpO2 physiological data. The physiological data can be reviewed locally on the display of the transmitter. The CentralStation will support ECG, Heart Rate, SpO2, Pulse Rate, Arrhythmia analysis, QT monitoring, and ST Segment Analysis for the TMS60. It must be operated by trained medical personnel in hospitals or medical institutions. WARNING • • • • 2.
General Product Description ■ 2.4 System Components Display supports Parameter auto-sizing. System Components The telemetry monitoring system (TMS60) includes the following components: 2.5 ■ Telemetry transmitter (TD60) ■ Telemetry antenna array ■ Telemetry receiver (RC60) TD60 Physical View 5 7 4 9 10 6 8 11 3 1 2 1. Display Activation (Power On/Off ) key When the TD60 is powered off ◆ Pressing this key will turn the TD60 on.
TD60 Physical View 2. 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 message area if the display is on. 3. 4. Main Menu key ◆ Pressing this key when on the main screen will open the main menu. ◆ Pressing this key when a menu is open will return to the main screen. ◆ Pressing this key when the display is off will turn the display on.
General Product Description 2.6 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). WARNING • 2.7 Authorized Mindray personnel are required to confirm the coverage area of the antenna array in the following situations: ◆ When the antenna array is initially installed.
Touch Screen Display 2.8.1 General Product Description Display Screen The main screen displays patient parameters and waveforms. A typical display screen is shown below. 1 2 3 4 5 1. 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. 2. 3. Alarm symbols ◆ indicates that the alarm system is reset. ◆ indicates that the technical alarm audio is turned off.
General Product Description 2.8.2 Touch Screen Display 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 1 6 2 3 5 2.8.2.2 4 1. Alphabetic buttons: tap to input the desired alphabetic text. 2. Delete button: tap to erase the text to the left of the cursor. 3. Accept button: tap to save the settings and exit the keyboard. 4. Space button: tap to input a space. 5.
Touch Screen Display 7. 2-8 General Product Description More punctuation buttons: tap to display the punctuation keyboard, as shown below.
3 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........................
Unpacking and Checking Getting Started WARNING • • • • • • 3.1 The telemetry monitoring system (TMS60) shall be installed by Mindray authorized personnel. The software equipment copyright is solely owned by Mindray. No organization or individual shall resort to altering, copying, or exchanging it or to any other infringement on it in any form or by any means without due permission. Connect only approved devices to this system.
Getting Started Environmental Requirements WARNING • • Before use, please verify whether the packages are intact, especially the packages of single use accessories. In case of any damage, do not apply it to patients. Do not let the display directly touch the patient when the display is on. NOTE • 3.2 Save the packing case and packaging material as they can be used if the device must be reshipped.
Connecting the ECG Leadwire 3.3 3-4 Getting Started Connecting the ECG Leadwire 1. Align the ECG leadwire plug with the ECG connector as indicated by the arrow in the following figure. 2. Insert the ECG leadwire plug into the ECG connector as shown in the enlarged figure below.
Getting Started Installing the Batteries WARNING • • Insert the ECG lead set into the ECG connector. The following performance may be affected by a weak connection: ◆ ECG signal quality ◆ Wireless signal strength ◆ Water resistance Do not use the ECG leadwire to move or lift the TD60. This may cause the device to fall, which may damage the equipment or injure the patient. NOTE • • 3.4 ECG leadwires are used as the antenna for the TD60.
Installing the Batteries 3.4.1 Getting Started Installing the Lithium-ion Rechargeable Battery WARNING • Only use specified lithium-ion rechargeable batteries. Use of other lithium-ion batteries will adversely affect the batteries: ◆ Level reporting ◆ Low battery alarms ◆ Life performance NOTE • 3-6 The lithium-ion rechargeable battery should be fully charged prior to first use. 1. Make sure the battery compartment is empty. 2.
Getting Started 3. 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: ■ TP-2AA battery tray can hold two AA batteries. ■ TP-3AA battery tray can hold three AA batteries. To install the AA batteries: 1.
Powering On the Unit Getting Started 3. Align the hook on the upper part of the battery tray with the slot on the battery compartment, as indicated by the enlarged part in the following figure. 4. Press down the battery tray until it closes firmly, as indicated by the arrow in the following figure. The TD60 is automatically powered on after the batteries are installed. 3.5 Powering On the Unit Press the key to turn on the TD60.
Getting Started Understanding Touch Gestures WARNING • 3.6 Check that visual and auditory alarm signals are presented correctly when the equipment is powered on. Do not use the equipment for any monitoring procedure on a patient if you suspect the equipment is not working properly or if the equipment is mechanically damaged. Contact your service personnel or Mindray.
Basic Operations 3.7.1 Getting Started Understanding the Screen Display Orientation The TD60 supports both the portrait and landscape display orientations. Example of portrait display 3.7.2 Example of landscape display ■ Portrait: both digital and waveform tiles take up the entire width of the screen. ■ Landscape: the digital tile takes up one half of the width of the screen; the waveform tile takes up the entire width of the screen.
Getting Started 3.7.5 Basic Operations 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. Refer to "Discharging the Patient" on page 5 - 4 for details. Standby Tap the button to enter the [Standby] menu. Refer to "Placing a Device in Standby" on page 5 - 3 for details.
Basic Operations Getting Started All menus contain the following parts: 1. Heading: displays the current menu title. 2. Scroll bar: indicates the current scroll position within the menu. 3. Main body: contains menus, buttons, and other controls to configure and operate the device. Controls Description Accesses a submenu to reveal more options or information. Indicates that a password is required for access. Submenus Contains more operations or information related to the corresponding menu.
Getting Started 3.7.8 Basic Operations Turning the Display On If the screen is off, press the or key to turn the display on. CAUTION • 3.7.9 Do not let the display directly touch the patient when the display is on. 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. To unlock the screen in Locked mode: 1. If the screen is off, press the [Screen Locked] menu. or 2. Input the passcode to unlock the screen.
Using the Pouch Getting Started WARNING • 3.8 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. The waterproof pouch with clear front is an appropriate means for holding the TD60.
Getting Started Using the Pouch Wearing the disposable pouch Wearing the reusable 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. NOTE • The pouch is used only for the TD60. The pouch cannot be used for carrying other personal devices, such as a mobile phone.
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4 User Configurations Introduction...............................................................................................................4-2 Configuring the Display.........................................................................................4-2 Configuring the Audio Volume...........................................................................
Introduction 4.1 User Configurations Introduction This chapter describes the configurations available for users to do, such as configuring the Display Setup, and Audio Volume. 4.2 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. 4.2.
User Configurations 4.2.4 Configuring the Display 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: 1. The areas shall be displayed in the order of the [Display Setup] menu except the digital area locations shall be optimized to reduce blank tiles. 2.
Configuring the Display 4.2.5 User Configurations Setting the Landscape Display 1. In the [Landscape] section of the [Display Setup] menu, tap [Rows]. Three options display: [2], [3], and [4]. 2. Tap an option to set the row numbers. The selected option displays to the right of [Rows]. 3. Tap [Landscape Order] to enter the [Landscape Order] menu. 4. Tap a parameter or waveform option to select it. The 4.2.6 icon displays to the right side of the selected parameter or waveform. 5.
User Configurations 4.3 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: 1. In the main menu, tap [Audio Volume]. 2. In the [Technical Alarm], [Touch Screen Click], or [Systole Beep] section, drag the slider to the left or right to adjust the volume. 3. Tap the icon to exit the [Audio Volume] menu.
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5 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 ...
Introduction 5.1 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. 5.2 Admitting a Patient When admitting a TM80 for the first time, the device must be admitted to the system through the CS. For details about admitting a patient through the CS, refer to the BeneVision Central Station Operator’s Manual (P/N 046-005011-00).
Patient Management Placing a Device in Standby NOTE • 5.4 When the device is connected to the CS, the patient category at the CS is updated if the patient category is changed at the TD60. Refer to the BeneVision Central Station Operator’s Manual (P/N 046-005011-00) for details. Placing a Device in Standby NOTE • When connected to the CS, and a device enters or exits Standby mode, the CS is also notified to enter or exit Standby mode.
Resume Monitoring 5.5 Patient Management Resume Monitoring Press the key to exit Standby mode. Resume monitoring: 5.6 ■ 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.
Patient Management 5.6.2 Discharging the Patient Restarting the TD60 1. If the TD60 is powered off, press the key to turn on the TD60. The device will prompt as to whether this is a new patient or not. 2. Select [Yes] if this is a new patient. Select [Yes] when asked to confirm that the discharge should begin. Refer to "Selecting the [Discharge Patient] menu" on page 5 - 4 for details on the discharge process.
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6 Alarms Introduction...............................................................................................................6-2 Alarm Categories......................................................................................................6-2 Alarm Levels...............................................................................................................6-2 Alarm Indicators .......................................................................................................
Introduction 6.1 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" on page 9 - 2. WARNING • 6.
Alarms 6.4 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 • 6.4.1 When the TD60 display is off, the user must activate the screen to view any local alarms. Alarm Light If a technical alarm occurs, the alarm light on the TD60 flashes. The color and flashing frequency correspond to the alarm level as follows: 6.4.
Alarm Indicators Alarms ◆ High level alarms: high-pitched triple beep ◆ Medium level alarms: double beep ◆ Low level alarms: low-pitched single beep NOTE • 6.4.3 When multiple technical alarms of different levels occur simultaneously, the TD60 selects the alarm of the highest level to light the alarm light and sound alarms accordingly, while all the alarm messages scroll in the message area on the top of the screen.
Alarms 6.5 6.6 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" on page 10 - 3. ■ For the CS alarm configurations, refer to the BeneVision Central Station Operator’s Manual (P/N 046-007960-00). Resetting the Alarms You can acknowledge the on-going alarms by resetting the alarms.
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7 Monitoring ECG Introduction...............................................................................................................7-2 Safety............................................................................................................................7-2 Preparation for Monitoring ECG .........................................................................7-3 Changing the ECG Settings ..................................................................................
Introduction 7.1 Monitoring ECG Introduction The chapter describes the ECG monitoring function of the TD60, including skin preparation 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. For details about CS configuration of the ECG parameters, QT analysis, ST analysis, and Arrhythmia analysis, refer to Chapter 9 Monitoring with the TD60 at the CS. 7.
Monitoring ECG Preparation for Monitoring ECG 7.3 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. The following procedure is recommended for secure electrode application: 1.
Preparation for Monitoring ECG 1. 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 electrode patches are not conductive. NOTE • • To prevent evaporation of the contact gel medium, peel the backing off of the electrode patch only when it is ready for use. If using the snap type lead wires, attach the electrode to the lead wire before placing the electrode on the patient. 2.
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). AHA IEC Lead position 7.3.3.
Preparation for Monitoring ECG 7.3.4.1 Monitoring ECG Standard 3-Leadwire Electrode Placement A 3-wire lead set can monitor one of three ECG vectors (I, II, or III). The recommended 3wire lead placement is as follows: RA LA R L F LL 3-wire lead placement (IEC) 3-wire lead placement (AHA) ■ Place the RA (white) electrode under the patient’s right clavicle, at the midclavicular line within the rib cage frame.
Monitoring ECG 7.3.4.2 Preparation for Monitoring ECG Standard 5-Leadwire Electrode Placement A 5-wire lead set can monitor seven ECG vectors (I, II, III, aVR, aVL, aVF, and V) simultaneously. The recommended 5-wire lead placement is as follows: 5-wire lead placement (IEC) 5-wire lead placement (AHA) ■ Place the RA (white) electrode under the patient’s right clavicle, at the midclavicular line within the rib cage frame.
Preparation for Monitoring ECG 7.3.4.3 Monitoring ECG Lead Placement: Pacemaker Patients The recommended lead placement for monitoring a pacemaker patient is as follows.
Monitoring ECG 7.3.5 Preparation for Monitoring ECG 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: 7.3.5.2 ■ Tap the lead fault message in the message area of the main screen. ■ In the main menu, tap [Lead Placement].
Preparation for Monitoring ECG 7.3.6 Monitoring ECG 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. OR 1. In the main menu, tap [Patient Info]. 2. In the [Pacer] field, check the setting of the paced status. The current paced status setting displays to the right of [Paced]. 3.
Monitoring ECG Changing the ECG Settings NOTE • 7.4 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: ■ On the main screen, tap the HR digital area or ECG waveform area to enter the [ECG] menu.
Changing the ECG Settings Monitoring ECG Options Description Settings* Filter Selects the ECG filter. Monitor, ST Monitor Use under normal measurement conditions. ST 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. 2. 7.4.2 Tap to exit the [ECG] menu.
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. 2. 7.4.4 Tap to exit the [ECG] menu. Configuring the Pacer 1. In the [Pacer] section of the [ECG] menu, tap the options described in the following table. Options Description Settings* Paced Selects the paced status.
Understanding the ECG Display 7.4.5 Monitoring ECG 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. 7.5 Understanding the ECG Display 7.5.1 HR Digital Area The HR digital area displays: 1. Parameter name 2. Measurement unit 3. Heart rate value 1 2 3 7.5.2 7 - 14 About the HR Digital Area ■ The HR area displays heart rate in the unit of bpm with a resolution of 1 bpm.
Monitoring ECG 7.5.3 Understanding the ECG Display ECG Waveform Area The ECG waveform area displays: 1. ECG Lead 2. ECG scale bar 3. ECG waveform 4. ECG filter setting 5. ECG scale 2 1 3 5 4 7.5.4 About the ECG Waveform Area ■ The ECG waveform, scale indicator, lead, and filter settings display in the configured ECG color. ■ The ECG waveform area provides scrolling, real-time waveform data and an erase bar to provide a time indicator of oldest and new data.
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8 Monitoring SpO2 (Optional) Introduction...............................................................................................................8-2 Measurement Limitations.....................................................................................8-2 Safety............................................................................................................................8-3 Connecting the SpO2 Module ............................................................................
Introduction 8.1 Monitoring SpO2 (Optional) Introduction The chapter describes the SpO2 monitoring function at the TD60 in detail, including connecting the SpO2 module, configuring the SpO2, and monitoring the SpO2. For details about the SpO2 parameter setup at the central station (CS), refer to Chapter 9 Monitoring with the TD60 at the CS.
Monitoring SpO2 (Optional) 8.3 Safety ■ Dysfunctional hemoglobin, such as carboxyhemoglobin (COHb) and methemoglobin (MetHb) ■ Presence of certain dyes, such as methylene and indigo carmine ■ Inappropriate positioning of the SpO2 sensor, or use of incorrect SpO2 sensor ■ Drop of arterial blood flow to immeaurable level caused by shock, anemia, low temperature or vasoconstrictor. ■ Inaccurate measurements may be caused by venous pulsations.
Connecting the SpO2 Module 8.4 Monitoring SpO2 (Optional) Connecting the SpO2 Module Connect the SpO2 module to the TD60. The TD60 can auto detect the SpO2 module type when the SpO2 module is connected.
Monitoring SpO2 (Optional) Changing the SpO2 Settings SpO2 module SpO2 sensor connector SpO2 sensor Connecting the Nonin SpO2 module 8.5 Changing the SpO2 Settings You can change the SpO2 settings from the SpO2 menu. 8.5.1 Configuring the SpO2 Setup Enter the SPO2 menu in either of the following ways: ■ On the main screen, tap the SpO2 digital area or SpO2 waveform area to enter the [SpO2] menu. ■ In the main menu, tap [Parameter Setup] → [SpO2] to enter the [SpO2] menu. 1.
Changing the SpO2 Settings Monitoring SpO2 (Optional) Options Description Settings* Display PI (Masimo only) Configures whether or not to show the perfusion index (PI) value in the digital area. The perfusion index allows clinicians to assess the pulse strength at the monitoring site for optimal sensor placement. PI gives the numerical value for the pulsatile to non-pulsatile portion of the measured signal caused by arterial pulsation. PI is an indicator of the pulsatile strength.
Monitoring SpO2 (Optional) Changing the SpO2 Settings Options Description Settings* Averaging (Masimo only) The user-selectable averaging feature allows the clinician to select the desired level of visibility to subtle variations in the measured value. Depending on the patient acuity and area of care, shorter averaging times are sometimes preferred (sleep testing) over longer averaging times (telemetry) and vice-versa.
SpO2 Measurement 8.5.2 Monitoring SpO2 (Optional) Configuring the SpO2 Waveform 1. In the [Waveform] field of the [SpO2] menu, select the options described in the following table. Options Description Settings* Speed Selects the SpO2 pleth waveform speed. 6.25 mm/s, 12.5 mm/s, 25 mm/s Display SIQ (Masimo only) Selects whether or nor to show the Signal Indicator Quality (SIQ) in the SpO2 waveform area.
Monitoring SpO2 (Optional) SpO2 Measurement WARNING • • • • When equipped with Masimo SpO2 module, use only Masimo SpO2 sensors specified in this manual. Use of other SpO2 sensors may cause improper oximeter performance. When equipped with Nonin SpO2 module, use only Nonin SpO2 sensors specified in this manual. Use of other SpO2 sensors may cause improper oximeter performance. Do not disconnect the Nonin Spo2 sensor connector from the Nonin SpO2 module during defibrillation.
Understanding the SpO2 Display Monitoring SpO2 (Optional) 8.7 Understanding the SpO2 Display 8.7.1 SpO2 Digital Area The SpO2 digital area displays: 1. Parameter name 2. SpO2 value 3. Perfusion indicator 4. Perfusion index (PI) label 5. Perfusion index value 6. SpO2 unit of measure 7. Pulse rate (PR) label 8. PR measurement unit 9.
Monitoring SpO2 (Optional) 8.7.2 8.7.3 Understanding the SpO2 Display About the SpO2 Digital Area ■ The SpO2 digital area displays in units of % with a resolution of 1%. ■ The SpO2 PR value displays in units of bpm with a resolution of 1 bpm. ■ Displays Masimo PI resolution as 0.01 when the PI value is smaller than 10%. ■ Displays Masimo PI resolution as 0.1 when the PI value is greater than or equal to 10%. ■ If the SpO2 measurement or PR is invalid, “- - -” displays in place of digits.
Masimo Information 8.8 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 applicable patents listed at: www.masimo.com/patents.htm.
9 Monitoring with the TD60 at the CS Introduction...............................................................................................................9-2 Physiological Alarms...............................................................................................9-2 ECG Monitoring ........................................................................................................9-12 QT Monitoring..........................................................................................
Introduction 9.1 Monitoring with the TD60 at the CS 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. 9.2 Physiological Alarms At the CS, you can view and change the physiological alarm limits and alarm levels in the [Alarm Setup] menu.
Monitoring with the TD60 at the CS Physiological Alarms WARNING • 9.2.1 If you switch off all arrhythmia alarms, the CS cannot give any arrhythmia alarms. Always keep the patient under close surveillance. Factory Default Parameter Alarm Limits The following table lists the factory default alarm limits for all parameters.
Physiological Alarms Monitoring with the TD60 at the CS Parameters Alarm limit Adult Pediatric SpO2 Desat High limit N/A N/A Unit of measure: % Invalid data: “--” Low limit 0 to 100 Default: 80 0 to 100 Default: 80 High limit (Low limit + 2) to 300 Default: 120 (Low limit + 2) to 300 Default: 160 Low limit 18 to (high limit - 2) Default: 50 18 to (high limit - 2) Default: 75 PR Unit of measure: bpm Invalid data: “--” * ΔQTc is only available for Mindray ECG algorithm. NOTE • 9.2.
Monitoring with the TD60 at the CS 9.2.3 Physiological Alarms Factory Default Parameter Alarm Settings The following table lists the factory default alarm levels and responses for all parameters.
Physiological Alarms Monitoring with the TD60 at the CS 9.2.4 Factory Default Arrhythmia Alarm Settings 9.2.4.
Monitoring with the TD60 at the CS Physiological Alarms Factory default alarm responses Alarm levels* Activation State Parameters Record on Alarm Print on Alarm Paging Switch Off Off Off Off X Off Off Off Off X X Off Off Off Off X X X On Off Off Off X X X X Off Off Off Off AFib X X X X Off Off Off Off Irr.
Physiological Alarms 9.2.4.2 Monitoring with the TD60 at the CS For Mortara Algorithm Factory default alarm responses Alarm levels* Activation State Parameters Record on Alarm Print on Alarm Paging Switch On Off Off Off — On Off Off Off — — On Off Off Off — — — On Off Off Off X — — — On Off Off Off PVCs/min X X X X On Off Off Off R on T X X X X On Off Off Off Run PVCs X X X X Off Off Off Off Couplet X X X X Off Off Off Off Vent.
Monitoring with the TD60 at the CS Physiological Alarms Factory default alarm responses Alarm levels* Activation State Parameters High Medium Low Message Irr.Rhythm — — X X Pauses/min X X X X Record on Alarm Print on Alarm Paging Switch Off Off Off Off On Off Off Off * X indicates available alarm level, — indicates alarm level not available ** The factory default settings are in bold. NOTE • The priority of lethal arrhythmia alarms is always high. It is unchangeable.
Physiological Alarms 9.2.5 Monitoring with the TD60 at the CS Arrhythmia Threshold Settings When an arrhythmia violates its threshold, an alarm is triggered. For the Mortara algorithm, 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 Arrh. event Range or Option Default Step Unit of measure PVCs High 1 to 100 10 1 minute Pauses/min 1 to 15 8 1 N/A Asys.
Monitoring with the TD60 at the CS 9.2.5.2 Physiological Alarms Mortara ECG algorithm Arrh. event Range or Option Default Step Unit PVCs High 1 to 100 10 1 minute Pauses/min 1 to 15 8 1 N/A Asys. Delay 2 to 10 4 1 seconds Vtac Rate 100 to 200 130 5 bpm Vtac PVC 3 to 12 6 1 beat Extreme Tachy Adult: 100 to 300 Pediatric: 160 to 300 Adult: 160 Pediatric: 180 5 bpm Extreme Brady Adult: 15 to 60 Pediatric: 15 to 80 Adult: 35 Pediatric: 50 5 bpm Multif.
ECG Monitoring 9.3 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 046-005011-00). 9.3.1 HR Settings The following table lists the HR settings in the [HR] section of the [ECG] tab.
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 option to direct the CS to send the HR alarm data to the configured recorder. On, Off Waveform Setup Select to display the [Waveform Setup] menu. Refer to "Waveform Setup" on page 9 - 13 for details. Other Settings Select to display the [Other Settings] menu. Refer to "Other Settings" on page 9 - 15 for details. * 9.3.
ECG Monitoring 9.3.2.2 Monitoring with the TD60 at the CS 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]. ■ When [Analysis Lead Setting] is set to [On], the ECG waveform configurations are applied for the displaying leads and analysis leads. Follow the steps below to configure the ECG waveform setting: 1.
Monitoring with the TD60 at the CS ECG Monitoring Settings* Options Description Lead Waveform size ECG 1 Select the desired ECG lead and set the corresponding gain for ECG 1 to display in the waveform area. I, II, III, aVR, aVL, aVF, V × 0.125, × 0.25, × 0.5, × 1, × 2, × 4 ECG 2 Select the desired ECG lead and set the corresponding gain for ECG 2 to display in the waveform area. I, II, III, aVR, aVL, aVF, V × 0.125, × 0.25, × 0.
ECG Monitoring Monitoring with the TD60 at the CS Options Description Settings* Filter Configures the ECG filter in all operating modes. Monitor, ST * ■ [Monitor]: use under measurement conditions. ■ [ST]: use when the ST monitoring is applied. normal The factory default settings are in bold. 9.3.4 ECG Display 9.3.4.1 ECG Digital Area The ECG digital area displays: 1. Area name 2. HR value 3. High HR alarm limit 4. Low HR alarm limit 5. Pauses threshold 6.
Monitoring with the TD60 at the CS ECG Monitoring NOTE • 9.3.4.2 If the Activation State for HR, PVCs or Pauses alarm is set to [Off], the symbol displays to the right of corresponding parameter. ECG Waveform Area The ECG waveform area displays: 1. ECG Lead 2. ECG waveform size 3. ECG filter setting 4. Notch filter setting 5. ECG waveform 6.
QT Monitoring 9.4 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.
Monitoring with the TD60 at the CS Options Description QT Computational Formula Configures the QTc formula used. QT Monitoring Settings* Bazett: QTHR- QTc = QT × -----------60 Fridericia: 1/2 QTHR- QTc = QT × -----------60 1/3 60 ------------- Framingham: QTc = QT + 154 × 1 – QTHR Hodges: QTc = QT + 1.75 × ( QTHR – 60 ) QT Alarm Setup QT View Configures the QT alarms.
QT Monitoring 9.4.3 Monitoring with the TD60 at the CS 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. The [QT View] menu displays, as shown in the following figure: ◆ The current waveform and parameter values display in green. ◆ The template waveform and parameter values display in yellow. ◆ The Q and T points are marked with a vertical line.
Monitoring with the TD60 at the CS 9.4.4 QT Monitoring QT Display When [QT Analysis] is enabled, the QT digital area displays: 1. Area name 2. QTc value 3. High QTc alarm limit 4. Activation State Off symbol for QTc alarm 5. ∆QTc label 6. ∆QTc value 7. High ∆QTc alarm limit 8. Activation State Off icon for ∆QTc alarm 9. QT value 10. QT label 11. QTc label 12. QT-HR label 13.
ST Monitoring 9.5 Monitoring with the TD60 at the CS ST Monitoring S ST deviation Depression or Elevation ST Point J Point P ISO Point R T 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 repolarization, or the end of the QRS complex (the J point) and the beginning of the Twave.
Monitoring with the TD60 at the CS ST Monitoring WARNING • 9.5.1 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. Measurement Limitations 9.5.2 ■ ST values may be affected by such factors as some drugs or metabolic and conduction disturbances. ■ Since ST is often calculated with a fixed delay from the J point, changes in heart rate may affect ST.
ST Monitoring 9.5.3 Monitoring with the TD60 at the CS 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 complexes are not considered for ST-segment analysis. WARNING • 1. Always make sure that the ST measurement points are appropriate for your patient. In the [ST Analysis] section of the [ECG] tab, click [Define ST Point].
Monitoring with the TD60 at the CS ST Monitoring Buttons Description Settings* ISO/J Selecting [Auto] fixes the ISO and J/ST points. Selecting [Manual] allows the clinician to manually adjust ISO and J/ST points. Auto, Manual For Mortara algorithm, the ISO and J/ST points can only be adjusted manually. ISO left arrow If [ISO/J] is set to manual, the button adjusts the ISO reference line to the left.
ST Monitoring 9.5.5 Monitoring with the TD60 at the CS ST Segment Display When [Display ST Segments] is enabled, the ST segments display in the waveform area: 1. Lead identifier 2. ST markers (ISO, J/ST) 3. ST value 4.
Monitoring with the TD60 at the CS 9.6 Arrhythmia Monitoring Arrhythmia Monitoring WARNING • The arrhythmia analysis program is intended to detect ventricular arrhythmias. It is not designed to detect atrial or supraventricular arrhythmias. It may incorrectly identify the presence or absence of an arrhythmia. Therefore, a physician must analyze the arrhythmia information with other clinical findings. • 9.6.1 Heart-rate reading may be affected by cardiac arrhythmias.
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 < the Vbrd Rate threshold. Lethal arrhythmia Extreme Tachy The heart rate is equal to or greater than the extreme tachycardia limit. Extreme Brady The heart rate is equal to or less than the extreme bradycardia limit. PVCs/min PVCs/min exceeds high limit. R on T R on T detected in normal heartbeats.
Monitoring with the TD60 at the CS 9.6.2.2 Arrhythmia Monitoring Mortara ECG Algorithm Arrhythmia message Description Category Asystole No QRS complex detected within the set time threshold (in absence of ventricular fibrillation or chaotic signals). Lethal 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.
Arrhythmia Monitoring 9.6.3 Monitoring with the TD60 at the CS 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 Arrhythmia Alarm Settings" on page 9 - 6 for details. Relearn Enables an arrhythmia relearning. Refer to "Relearning" on page 9 30 for details.
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 • 9.6.5 Initiate ECG relearning only during periods of normal rhythm and when the ECG signal is relatively noise-free. If ECG learning takes place during ventricular rhythm, the ectopics may be incorrectly learned as the normal QRS complex.
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. Default Automatically sets the default threshold: 0.16 mV. Manually adjust the minimum QRS detection threshold.
Monitoring with the TD60 at the CS 9.7 SpO2 Monitoring SpO2 Monitoring At the CS, you can view and change the SpO2 settings in the [SpO2] tab of the [Parameter Setup] menu. For details about the [Parameter Setup] menu, refer to the BeneVision Central Station Operator’s Manual (P/N 046-005011-00). 9.7.1 Measurement Limitations Refer to "Measurement Limitations" on page 8 - 2 for details. 9.7.2 SpO2 Settings The following table lists the SpO2 settings in the [SpO2] tab.
SpO2 Monitoring Monitoring with the TD60 at the CS Options Description Settings* Desat Limit (%) Configures the SpO2 Desat low limit. 0 to 100 The default is 80. Averaging (Masimo only) The option is not configurable. The option setting is synchronous with the setting at the TD60. Refer to "Configuring the SpO2 Setup" on page 8 - 5 for details. * The factory default settings are in bold. 9.7.3 SpO2 Display 9.7.3.1 SpO2 Digital Area The SpO2 digital area displays: 1. Area name 2.
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 SpO2 digital area. Nonin SpO2 digital area 9.7.3.2 SpO2 Waveform Area The SpO2 waveform area displays: 1. Area name 2.
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10 Configuring the TD60 Introduction...............................................................................................................10-2 Maintenance Menu .................................................................................................
Introduction 10.1 Configuring the TD60 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: 10.2.1 10.2.2 ■ General ■ Alarms ■ Quick Keys ■ Defaults ■ Screen Lock ■ Edit Passcodes ■ Device Name ■ Demo Mode ■ Service Entering the Maintenance menu 1.
Configuring the TD60 Maintenance Menu Options Description Settings* Location Changes the hospital and department names. N/A Notch Filter Configures the ECG Notch filter. This option is used to filter out AC line noise from the ECG waveform. 50 Hz, 60 Hz, Off The default is 50 Hz when the device is not configured for the US. ECG Lead Labeling Changes the ECG lead labeling. AHA, IEC Calibrate ECG Enables or disables the ECG verification.
Maintenance Menu Configuring the TD60 Section & Options Description Settings* Reminder Tone Allows an authorized user to enable or disable the reminder tone. If the alarm tone is turned off, enabling this setting can issue a periodic reminder tone. On, Off Reminder Interval Allows an authorized user to configure the intervals between the alarm tones. 1 min, 2 min, 3 min, 5 min, 10 min Timeout Minimum Alarm Volume Technical Allows an authorized user to set the minimum technical alarm volume.
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. Do not rely exclusively on the audible alarm system for monitoring. Adjustment of alarm volume to a low level may result in a hazard to the patient. Always keep the patient under close surveillance. 10.2.4 Quick Keys Menu 10.2.4.
Maintenance Menu Configuring the TD60 A list of options 10.2.4.2 3. Tap the desired option from the list of options to configure the selected quick key. 4. Repeat steps 2 to 3 to configure other quick keys, if needed. 5. Tap to exit the [Quick Keys] menu. Deleting a Quick Key 1. From the quick keys area at the bottom of the [Quick Keys] menu, press and hold the desired quick key for two seconds, and then release it. The quick key background turns to red and displays [Delete]. 2. Tap [Delete].
Configuring the TD60 Maintenance Menu Options Description Import Device Settings Copies the settings from the external device to theTD60 unit. Refer to "Transferring 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. 3. 10.2.6 Tap to exit the [Defaults] menu.
Maintenance Menu Configuring the TD60 ◆ To retry the import from the TD60 unit, tap the external device which is displaying 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. 10.2.7 Screen Lock Menu 10.2.7.1 Understanding the Screen Lock Mode There are two modes of being able to lock the screen to assist in preventing unauthorized use.
Configuring the TD60 10.2.7.3 Changing the Current Screen Lock Passcode 1. 10.2.8 In the [Maintenance] menu, tap [Screen Lock]. 2. Tap [Screen Lock Passcode]. 3. Input the current password. 4. Input and verify the new password Changing the Passwords 1. In the [Maintenance] menu, tap [Edit Passwords]. 2. 10.2.9 Maintenance Menu ◆ Tap [Maintenance Password] and follow the on-screen instructions to change the maintenance password.
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11 Battery Introduction...............................................................................................................11-2 Safety............................................................................................................................11-2 Installing the Battery ..............................................................................................11-3 Checking the Battery Charge Status .................................................................
Introduction 11.1 Battery 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 SE WARNING • • • • • • • • • • 11 - 2 Keep the batteries out of children’s reach. Keep the batteries in their original package until you are ready to use them. The battery compartment should be closed during defibrillation.
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. High temperature can cause burns to the patient or user. If the device becomes too hot to the touch, remove it from the patient and place aside until it cools.
Checking the Battery Charge Status 11.4 Battery 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 • 11.5 If the “Low Battery” or “Critically Low Battery” alarm occurs, the TD60 turns off the audio, the screen display the “Local Audio Off” message, and the screen brightness turns dimmer.
Battery Charging the Rechargeable Lithium-ion Battery 2. 11.6 Remove the lithium-ion battery pack or AA battery tray from the TD60. 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.
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). Storing batteries in a cool place can slow the aging process.
Battery Maintaining the Rechargeable Lithium-ion Battery NOTE • 11.8 Replace the AA battery frame on the battery compartment after removing the AA batteries. Maintaining the Rechargeable Lithium-ion Battery Take care of the rechargeable lithium-ion battery once you receive a new battery for use. The following table describes the battery maintenance activities and recommended frequency. Activity Recommended Frequency Visual inspection Before installing a battery in the TD60.
Disposing of the Batteries Battery NOTE • The battery capacity degrades as using time and number of recharge cycles.Toward the end of its useful life, the battery capacity may be reduced by 20% to 25%. If the reduced battery life is unacceptable for your device, Mindray recommends the battery be replaced. 11.9 Disposing of the Batteries 11.9.1 Disposing of the Rechargeable Lithium-ion Battery Discard the lithium-ion battery in the following situations: ■ The battery has visual signs of damage.
12 Troubleshooting General Problems ....................................................................................................12-2 Physiological Alarm Messages at the CS .........................................................12-3 Technical Alarm Messages at the TD60 ...........................................................
General Problems 12.1 Troubleshooting 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 12.1.2 Troubleshooting Tools ■ Telemetry Receiver (RC60) ■ TD60 ■ Central Station (CS) Problem List Symptom Possible cause Solution No RF Signal (The RC60 does not receive valid data for consecutive 5 seconds) 1. The TD60 battery charge is to be depleted. 1.
Troubleshooting Physiological Alarm Messages at the CS Symptom Possible cause Solution The AC power indicator on the RC60 is off. 1. The RC60 is not connected to the power. 1. Check if the RC60 is connected to the power. 2. The RC60 is power off. 2. Check if the RC60 sounds a beep when turn the receiver on. The TD60 or SpO2 module restarts repeatedly. The TD60 battery charge is to be depleted. 12.2 Replace with new batteries.
Physiological Alarm Messages at the CS Troubleshooting Measurement Alarm message Alarm level Possible cause Solution ECG ECG Weak Signal High The ECG signal is so weak that the monitor can’t perform ECG analysis. Check the patient’s condition and the ECG connections. Asystole High The patient is in arrhythmia. Vfib/Vtac High Check the patient’s condition and the ECG connections. VTac High Vent.
Troubleshooting Technical Alarm Messages at the TD60 Measurement Alarm message Alarm level Possible cause Solution SpO2 SpO2 Desat High The SpO2 value has fallen below the desaturation alarm limit. Check the patient’s condition and check if the alarm limit settings are correct. No Pulse High The pulse signal was so weak that the monitor cannot perform pulse analysis. Check the patient’s condition, SpO2 sensor and measurement site. * 12.
Technical Alarm Messages at the TD60 Measurement ECG SpO2 Troubleshooting Alarm message Alarm level Alarm Indication Possible cause Solution ECG Noise Low A The ECG signal is noisy. Check for any possible sources of signal noise around the cable and electrode, and check the patient for great motion. ECG Cable Type Error Low B Connect wrong ECG leadwire. Reconnect the 3 or 5 lead ECG leadwire. HR Overrang e Low A HR exceeds the measurement limit. Contact your medical pesonnel.
Troubleshooting Measurement Power System Technical Alarm Messages at the TD60 Alarm message Alarm level Alarm Indication Possible cause Solution Low Battery Medium A The battery charge is low. Replace with new batteries. Critically Low Battery High A The battery charge is almost depleted. Battery Mainten ance Required Medium A The lithium-ion battery is aging. Battery Error Medium A The lithium-ion battery communication is error.
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13 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 ....
Introduction 13.1 Cleaning and Disinfecting Introduction Only use the substances approved by Mindray and methods listed in this chapter to clean or disinfect your device. Our warranty does not cover damage caused by unapproved 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 hospital’s Infection Control Officer or Epidemiologist. 13.
Cleaning and Disinfecting Cleaning of the TD60 CAUTION • • • 13.3 If liquid has accidentally entered the system or its parts, shut down the system and have the device serviced by authorized service personnel. Remove the equipment from use if liquid is spilled on the equipment or accessories. Contact your service personnel. When cleaning, avoid the ECG leadwire connector and other connectors. Cleaning of the TD60 CAUTION • Only use the following approved cleaning solutions.
Cleaning the Reusable ECG Leadwires, SpO2 Modules and Sensors 13.4 Cleaning and Disinfecting 2. Dilute the mild soap in water to make a cleaning solution. 3. Soak a clean and soft cloth in the solution and wring out excess solution. 4. Thoroughly wipe the display screen and the exterior surface of the device with the damp cloth, avoiding the connectors. 5. Wipe off all the cleaning solution with a dry cloth if necessary. 6. Dry your device in a ventilated, cool place.
Cleaning and Disinfecting 13.5 Cleaning the Battery and Battery Compartment 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. Use caution to avoid the battery connector.
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14 Maintenance Introduction...............................................................................................................14-2 Safety............................................................................................................................14-2 Regular Check ...........................................................................................................14-3 Maintenance and Testing Schedule..................................................................
Introduction 14.1 Maintenance Introduction The chapter outlines the routine telemetry devices maintenance guidelines. The telemetry devices are designed for stable operation over long periods of time. Under normal circumstances the devices should not require technical maintenance beyond that described in this chapter. However, routine maintenance, calibration and safety checks are recommended at least once a year or more often as required by local statutory or hospital administration practice. 14.
Maintenance 14.3 Regular Check 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. ■ Connectors are not loose, cracked, or bent and cables have no cuts, nicks, or fraying. ■ ECG leadwires are securely connected with the equipment. ■ Battery pack is installed and has sufficient charge.
Maintenance and Testing Schedule 14.4 Maintenance 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 equipment before any test and maintenance. Check/Maintenance Item Recommended Frequency Visual inspection When first installed or reinstalled.
Maintenance Verifying the ECG at the TD60 6. Compare the amplitude of the square wave with the wave scale. The difference should be within 5%. 7. After completing the verification, disable [Calibrate ECG].
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15 Accessories ECG Accessories........................................................................................................15-2 SpO2 Accessories .....................................................................................................15-3 Miscellaneous............................................................................................................
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. For details about the accessories, refer to the instructions for use provided with the accessory. WARNING • • • • • Use accessories specified in this chapter.
Accessories 15.1.
SpO2 Accessories 15.2.
Accessories 15.3 Miscellaneous Miscellaneous PN 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.
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A Product Specifications Classifications............................................................................................................A-2 Environmental Specifications..............................................................................A-2 Power Supply Specifications................................................................................A-3 Physical Specifications ...........................................................................................
Classifications A.1 Product Specifications Classifications The Telemetry Monitoring System is classified, according to IEC60601-1: TD60: energized from an internal electrical power source. RC60: class I. Central Charger: class I. Type of protection against electrical shock Degree of protection against electrical shock for the TD60 Type CF defibrillation proof for ECG, and SpO2.
Product Specifications Power Supply Specifications A.3 Power Supply Specifications A.3.1 TD60 The TD60 is powered by batteries. Battery type AA batteries (two or three) Rechargeable lithium-ion battery (one) Capacity for lithium-ion battery ≥ 3500 mAh Safety and authentication for lithium-ion battery UL2054, IEC62133, UN38.
Physical Specifications A.3.3 Product Specifications Central Charger The central charger is powered by external AC power. Input voltage 100 VAC to 240 VAC (± 10%) Frequency 50 Hz/60 Hz (±3 Hz) Input current 1.5 A to 0.75 A At the room temperature: ≤ 5 hours Charge time Overcharge protection function The charge time definition: the time for the battery from the exhausted status to 90% battery charge (within the operating temperature range declared for the unit).
Product Specifications Hardware Specifications A.5 Hardware Specifications A.5.1 TD60 Display Screen type Color TFT LCD screen Screen size 3.5" Resolution 480 pixels × 320 pixels Display Activation (Power On/Off) key The switch time is less than or equal to two seconds.
Hardware Specifications A.5.2 Product Specifications RC60 LED Communications indicator 1 (green), indicates the ready and communications status. Power indicator 1 (green), indicates the power status. Audio Indicator 1, indicates internal abnormity. Buzzer External Connectors Ethernet connector 1, standard RJ45 connector Antenna connector 2 A.5.3 Central Charger Charger slot 10 LED 10, which indicates the battery charge status.
Product Specifications Wireless Specification A.6 Wireless Specification A.6.1 Technique Specification Protocol standard Private protocol Debugging mode GFSK Work frequency 608 MHz to 614 MHz Channel interval 25 KHz Wireless baud rate 8 kbps ± 3% Output power < 10 mW Receiving sensitivity ≤-110 dBm (≤ 1% error code rate) Data security Private protocol A.6.
Wireless Specification A.6.3 Product Specifications Function Specification WARNING • Do perform all network functions of data communication within an enclosed network. Data integrity Code error ≤ 1% Data latency Total delay of data transmission from the transmitter to the CS: ≤ 3 seconds Priority All communication data type have the same priority. Transmission distance Distinct vision distance between the transmitter and the receiver antenna is greater than or equal to 50 m.
Product Specifications Mindray Patient Area Network (PAN) Specification A.7 Mindray Patient Area Network (PAN) Specification A.7.1 Technique Specification Protocol standard Mindray PAN low energy 4.0 Debugging mode GFSK Work frequency 2400 MHz to 2483.5 MHz Channel interval 2 MHz Wireless baud rate 1 Mbps Output power ≤ 1 mW Data Security 128 bit AES A.7.2 Implemented Function The function implemented by the Mindray PAN is transferring the configuration between the transmitters. A.7.
Measurement Specifications Product Specifications A.8 Measurement Specifications A.8.1 ECG ECG Standard Meet standards of IEC60601-2-27 and IEC60601-2-25 Leadset 3-lead: I, II, III 5-lead: I, II, III, aVR, aVL, aVF, V Automatic 3/5 lead recognition ECG standard AHA, IEC Sweep speed 6.25 mm/s, 12.5 mm/s, 25 mm/s Accuracy: ± 10% Display Sensitivity 1.25 mm/mV (×0.125), 2.5 mm/mV (×0.25), 5 mm/mV (×0.
Product Specifications Defibrillation energy absorption Measurement Specifications ≤ 10% (100 Ω load) Pace Pulse Pace pulse markers Pace pulses meeting the following conditions are labelled with a PACE marker: Amplitude: ±2 mV to ±700 mV Width: 0.1 ms to 2 ms Rise time: 10 μs to 100 μs Amplitude: ≥ 0.2mV RTI Pace pulse rejection When tested in accordance with the IEC60601-2-27: 201.12.1.101.13, the heart rate meter rejects all pulses meeting the following conditions.
Measurement Specifications HR averaging method Product Specifications Mindray ECG algorithm Mortara ECG algorithm In compliance with the requirements in Clause 201.7.9.2.9.101 b) 3) of IEC60601-2-27, the following method is used: If the last 3 consecutive RR intervals are greater than 1200 ms, the 4 most recent RR intervals are averaged to compute the HR. Otherwise, heart rate is computed by subtracting the maximum and minimum ones from the most recent 12 RR intervals and then averaging them.
Product Specifications Measurement Specifications Resolution 0.01 mV Accuracy -0.8 mV to +0.8 mV: ± 0.02 mV or ± 10%, whichever is greater Beyond this range: Not specified Arrhythmia Analysis Arrhythmia analysis classifications Mindray ECG algorithm Mortara ECG algorithm Asystole, VFib/VTac, Vtac, Vent. Brady, Extreme Tachy, Extreme Brady, PVCs/min, Pauses/min, R on T, Run PVCs, Couplet, Multif. PVC, PVC, Bigeminy, Trigeminy, Tachy, Brady, Pacer Not Pacing, Pacer Not Capture, Missed Beat, Nonsus.
Measurement Specifications A.8.2 Product Specifications SpO2 NOTE • A.8.2.1 A functional tester or SpO2 simulator can be used to determine the pulse rate accuracy. Nonin SpO2 Module SpO2 Measurement range 0% to 100% Resolution 1% Accuracy 70-100%: ±3 digits 0-69%: Not specified Data update rate ≤2s *Studies were performed to validate the accuracy of Pulse Oximeter with Nonin SpO2 sensors by contrast with a CO-Oximeter.
Product Specifications Measurement Specifications ±3 bpm Accuracy Response Time ■ ≤ 25 s (PR 75 bpm, average time 4 heart beats, no disturbance, SpO2 value rises from 70% to 100%) ■ ≤ 35 s (SpO2 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 SpO2 Sensors 7000A, 7000P, 8000AA, 8000AP SpO2 = 1.01 × SaO2 – 2.
Measurement Specifications Product Specifications Bland-Altman Plots of the Bias versus the Mean A.8.2.3 Masimo SpO2 Module SpO2 Measurement range 1% to 100% Resolution 1% Accuracy 70 to 100%: ±2% (measured without motion in adult/pediatric mode) 70 to 100%: ±3% (measured with motion) 1% to 69%: Not specified. Low Perfusion Conditions Pulse amplitude: > 0.
Product Specifications Measurement Specifications Measured Arms Values SaO2 range LNCS Adtx, LNCS Pdtx LNCS DCI, LNCS DCIP 70% to 100% ± 2% 2% 70% to 80% 1.55% 0.60% 80% to 90% 1.07% 0.54% 90% to 100% 1.64% 0.
Measurement Specifications A.8.2.
B EMC TMS60 Operator’s Manual B-1
EMC 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. Keep a close eye on the system in case there are other devices around it.
EMC 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. Immunity test IEC 60601 Test level Compliance level Electromagnetic environment - guidance Electrostatic Discharge (ESD) IEC 61000-4-2 ± 6 kV contact ± 8 kV air Floors should be wood, concrete or ceramic tile.
EMC 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. Immunity test IEC 60601 Test level Compliance level Conduced RF IEC 61000-4-6 3 Vrms 150kHz to 80MHz 3 Vrms Radiated RF IEC 61000-4-3 3 V/m 80MHz to 2.
EMC If the system is operated within the electromagnetic environment listed in Table Guidance and declaration — electromagnetic immunity, the system will remain safe and provide the following essential performance: ■ Operating mode ■ Accuracy ■ Function ■ Accessories identification ■ Data stored ■ Alarm ■ Detect for connection Recommended separation distances between portable and mobile RF communication and the system The system is intended for use in an electromagnetic environment in which r
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C 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.
FCC Compliance NOTE ● This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications.
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 affe
FCC Compliance C-4 Item Parameter Operating Frequency Band (MHz) 608 to 614 Modulation GFSK Transmitter Output Power(e.i.r.
D Symbols and Abbreviations Units..............................................................................................................................D-2 Symbols .......................................................................................................................D-3 Abbreviations ............................................................................................................
Units D.1 Symbols and Abbreviations Units A D-2 ampere Ah ampere hour bpm beats per minute °C centigrade cc cubic centimeter cm centimeter dB decibel DS dyne.
Symbols and Abbreviations D.2 D.
Abbreviations D-4 Symbols and Abbreviations err error ES electrosurgical ESU electrosurgical unit HR heart rate HT height IEC International Electrotechnical Commission ISO International organization for standardization MRI magnetic resonance imaging LA(L) left arm LAP left atria pressure LED light emitting diode LL(F) left leg Loop loop read-write test fail M, MEAN mean pressure O2 oxygen P power PAN Patient Area Network PR pulse rate QRS interval of ventricular depol
E E.1 Anomaly Anomaly Description This product does not have any anomalies.
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P/N: 046-007056-00 (1.
