User Manual WMTS Access Point AP70 Mindray Shenzhen Mindray BIO-Medical electronics Co.,LTD.
Introduction © Copyright 2019 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. All rights reserved. ■ Release time: 2019-10 ■ Revision: 4.0 WARNING • Federal Law (USA) restricts this device to sale by or on the order of a physician or other practitioner licensed by U.S. state law to use or order the use of this device.
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 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 ...............
4 User Configurations ................................................................................................................. 4 - 1 4.1 Introduction .................................................................................................................................................. 4 - 2 4.2 Configuring the Display ........................................................................................................................... 4 - 2 4.2.1 Entering the Display Setup Menu ....
6.10 Latching Alarms ......................................................................................................................................6 - 10 6.11 Actions When an Alarm Occurs ........................................................................................................6 - 10 7 Monitoring ECG ........................................................................................................................ 7 - 1 7.1 Introduction ............................................
8 Monitoring SpO2 (Optional) .................................................................................................... 8 - 1 8.1 Introduction .................................................................................................................................................. 8 - 2 8.2 Measurement Limitations ....................................................................................................................... 8 - 2 8.3 Safety .........................................
10.5 Interactions after Pairing a TM80/TM70 with a BP10 ................................................................10 - 7 10.5.1 Overview of Interactions ......................................................................................................10 - 7 10.5.2 Operating the BP10 via the TM80/TM70 ........................................................................10 - 7 10.5.3 NIBP Operations at the TM80/TM70 ................................................................................
12.10.3 Understanding the Arrhythmia Events ..................................................................... 12 - 22 12.10.4 Setting Arrhythmia Alarm Properties ........................................................................ 12 - 22 12.10.5 Changing Arrhythmia Alarm Threshold Settings .................................................. 12 - 22 12.10.6 Setting PVC-Related Alarms Threshold ..................................................................... 12 - 22 12.10.
14.3 Installing the Battery .............................................................................................................................14 - 3 14.4 Checking the Battery Charge Status ...............................................................................................14 - 4 14.5 Removing the Battery ...........................................................................................................................14 - 4 14.6 Charging the Rechargeable Lithium-ion Battery ...
18.2.1 Masimo SpO2 Module ..........................................................................................................18 - 4 18.2.2 Masimo SpO2 Sensor ............................................................................................................18 - 4 18.2.3 Nonin SpO2 Module ..............................................................................................................18 - 5 18.2.4 Nonin SpO2 Sensor .................................................................
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 TM80/TM70 is intended to be used for a single patient at a time. The TM80/TM70 must be operated by medical personnel in hospitals. 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 TM80/TM70 in conjunction with Electro Surgical Unit (ESU). Do not expose the TM80/TM70 to a Magnetic Resonance (MR) environment.
Safety Information Safety WARNING • • 1.1.2 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 of the TM80/TM70 directly touch the patient when the display is on.
Safety Safety Information CAUTION • • • 1.1.3 The TM80/TM70 generates and uses the Radio Frequency (RF) energy. If it is not installed correctly or not used as per the manual, RF interference to other equipment could result. Signal quality can be impacted on an ambulatory patient by the construction materials used within the hospital. 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.
Equipment Symbols 1.
2 General Product Description Indications for Use...................................................................................................2-2 Applied Parts .............................................................................................................2-2 Network Components of TM80/TM70..............................................................2-3 System Components ..............................................................................................2-5 Physical View ....
Indications for Use 2.1 General Product Description Indications for Use The TM80/TM70 telemetry monitor is intended for use on Adult and Pediatric patients over three years old to monitor ECG, SpO2, NIBP and Resp physiological data. The physiological 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/TM70.
General Product Description 2.3 Network Components of TM80/TM70 Network Components of TM80/TM70 TM80/TM70 network consists of the following components: ■ Central Monitoring System (CMS): The BeneVision Central Monitoring System ( CMS) is a networked patient monitoring system intended for use in a fixed location, installed in professional healthcare facilities to provide clinicians remote patient monitoring. ■ AC70: The AC70 is the access controller for AP70 and TM70 management and event review.
Key Features General Product Description TM80/TM70 Network Components 2.4 2-4 Key Features ■ 3.5" color PTC touch screen display is easy for clinicians to use. ■ Small, portable, and lightweight for patients to wear. ■ The TM80/TM70 supports 3/5/6-lead ECG. ■ Supports Masimo SpO2 module, Nonin SpO2 module, and Nellcor SpO2 module. ■ Communication to the CMS utilizes WLAN for the TM80/TM70. ■ Displays the battery status and supports the multiple levels of battery alarms.
General Product Description 2.5 System Components System Components The TM80/TM70 telemetry monitor includes the following components: ■ TM80/TM70 Telemetry Monitor main unit ■ NIBP module (BP10) ■ Central charger ■ Accessories This manual only describes the TM80/TM70 Telemetry Monitor main unit (hereinafter called the TM80/TM70).
Physical View 2.6 General Product Description Physical View 5 7 4 9 10 8 6 11 3 1 2 1. Display Activation (Power On/Off ) key When the device is powered off ◆ Pressing this key will turn the device on. When the device is powered on 2. ◆ If the screen display is on, pressing this key will turn the display off. ◆ If the screen display is off, pressing this key will turn the display on. ◆ Press and hold this key for two seconds to display the power off confirmation menu.
General Product Description Touch Screen Display The touch screen is the primary user interface for operating the device and viewing information (or patient data). 5. Alarm light/indicator Flashes in different color and frequency corresponding to the alarm level. 6. ECG connector Connects the ECG leadset. SpO2 cap 7. Covers SpO2 connector when SpO2 is not in use. 8. SpO2 connector Connects the SpO2 module. 9. Speaker 10. USB connector It is only available for authorized service personnel. 11.
Touch Screen Display 2.7.1 General Product Description Display Screen The main screen displays patient parameters and waveforms. A typical display screen of TM80/TM70 is shown below.
General Product Description 1. Touch Screen Display Patient information area This area shows the patient information such as patient size, device name, department name, room number, and bed number. Tapping this area displays the [Patient Info] menu. 2. 3. 4. Mindray Patient Area Network (herein abbreviated as MPAN) indicator ◆ indicates that the TM80/TM70 is not paired with the BP10 or one TM80/ TM70 is not connected to another TM80/TM70 for configuration transfer.
Touch Screen Display General Product Description Tapping this area displays the [Alarm Summary] menu, where you can view alarm messages. 7. Patient data area This user configurable area can display parameter/waveform data. The parameter/ waveform is labeled in the upper left corner. You may also tap this area to display the Setup menu for the corresponding parameter/waveform. For details about the touch screen operations, refer to "Basic Operations" on page 3 10. 2.7.
General Product Description Touch Screen Display 1. Numeric buttons: tap to input the desired numbers. 2. Punctuation buttons: tap to input the desired punctuation mark or symbol. 3. Delete button: tap to erase the text to the left of the cursor. 4. Accept button: tap to save the settings and exit the keyboard. 5. Space button: tap to input a space. 6. Alphabetic switch button: tap to switch to the alphabetic layout. 7.
Touch Screen Display 2 - 12 General Product Description TM80/TM70 Telemetry Monitor Operator’s Manual
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 network 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. Devices connected to the equipment must meet the requirements of the applicable IEC standards (e.g.
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. NOTE • 3.2 Save the packing case and packaging material as they can be used if the device must be reshipped. Environmental Requirements The operating environment of the system must meet the requirements specified in this manual.
Connecting the ECG Leadwire Getting Started NOTE • 3.3 3-4 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 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 TM80/TM70. This may cause the device to fall, which may damage the equipment or injure the patient. NOTE • 3.4 Insert the SpO2 cap in the SpO2 connector when SpO2 is not in use.
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 Installing the Batteries The TM80/TM70 is automatically powered on after the battery is installed. 3.4.2 Installing the AA Batteries To install the AA batteries: 1. Make sure the battery compartment is empty. 2. Insert three 1.5V alkaline AA batteries according to the diagram in the bottom of the battery frame as shown in the images below. Installing three AA batteries 3.
Powering On the Unit 4. Getting Started Press down the battery frame until it closes firmly, as indicated by the arrow in the following figure. The TM80/TM70 is automatically powered on after the batteries are installed. 3.5 Powering On the Unit Press the key to turn on the TM80/TM70. The cyan alarm light will momentarily turn on to indicate that the device is starting. The TM80/TM70 performs a self-test during startup. The alarm light flashes red, yellow, and cyan in turn, and then off.
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 Getting Started Basic Operations This section describes the basic operations for the TM80/TM70. WARNING • 3.7.1 Patients should be instructed not to interact with the display of the device and to not open the battery compartment while the TM80/TM70 is in use. Understanding the Screen Display Orientation The TM80/TM70 supports both the portrait and landscape display orientations. Example of landscape display Example of portrait display 3.7.
Getting Started 3.7.3 Switching the Screen Display Orientation 1. 2. 3.7.4 Basic Operations Flick your finger down from the top of the main screen to display the screen orientation switch buttons. ◆ : switches portrait display to landscape display counterclockwise. ◆ : switches portrait display to landscape display clockwise. ◆ switches landscape display horizontally. ◆ : switches landscape display to portrait display. Tap the desired button.
Basic Operations 3.7.5 Getting Started 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. 1 4 3 2 Example of the Main Menu All menus contain the following parts: 1. Heading: displays the current menu title. 2. Scroll bar: drag the bar to scroll the menu. 3. Main body: contains menus, buttons, and other controls to configure and operate the device.
Getting Started 3.7.6 Basic Operations 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. For details about configuring the time for Display Auto Off, refer to "Configuring the General Menu" on page 13 - 2. NOTE • 3.7.
Using the Pouch 3.7.9 Getting Started Unlocking the Screen in View Only Mode 1. If the screen is off, press the or 2. Press the 3. Input the passcode to unlock the screen. key to turn the display on. key to display the [Screen Locked] menu. Once the passcode is entered the screen is temporarily unlocked. If the is pressed or the device times out, the screen will lock again and a passcode must be entered. For details about setting the screen lock, refer to "Screen Lock Menu" on page 13 - 14. 3.
Getting Started Using the Pouch For disposable pouch For reusable pouch 2. Pinch the snap-fastener to close the pouch. 3. Secure the pouch on the patient with ties around the patient’s shoulder and under the arm, as shown in the following figure. Wearing the disposable pouch Wearing the reusable pouch For more information on using the pouch, refer to Pouch Instructions for Use (P/N 046007058-00).
Using the Pouch Getting Started WARNING • While using a pouch with the TM80/TM70 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 • 3 - 16 The pouch is used only for the TM80/TM70. The pouch cannot be used for carrying other personal devices, such as a mobile phone.
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 layout, display orientation, and screen brightness in the [Display Setup] menu. 4.2.1 Entering the Display Setup Menu To enter the [Display Setup] menu, follow this procedure: 4.2.2 1. Press to enter the main menu. 2. Tap [Display Setup].
User Configurations 1. Configuring the Display In the [Portrait] section of the [Display Setup] menu, tap [Rows]. Three options display: [2], [3], and [4]. 2. Tap an option to set the row numbers. The selected option displays to the right of [Rows]. 3. Tap [Portrait Order] to enter the [Portrait Order] menu. 4. Tap a parameter or waveform to select it. The 4.2.5 icon displays to the right of the selected parameter or waveform. 5.
Configuring the Audio Volume 4. Tap a parameter or waveform option to select it. The 4.2.7 User Configurations icon displays to the right side of the selected parameter or waveform. 5. Drag the selected parameter or waveform to the desired position, and then release it. 6. Repeat steps 4 and 5 until the desired order is configured. 7. Tap the icon to exit the [Landscape Order] menu. Configuring the Display Brightness To configure the display brightness, follow this procedure: 1.
5 Patient Management Introduction...............................................................................................................5-2 Admitting a Patient .................................................................................................5-2 Changing Patient Information ............................................................................5-2 Changing Paced Status..........................................................................................
Introduction 5.1 Patient Management Introduction The chapter describes how to admit a patient, change the patient category, enter and exit the Standby mode, and discharge the patient. 5.2 Admitting a Patient After discharging the current patient, you can admit a new patient by pressing the button. For how to discharge a patient, refer to "Discharging the Patient" on page 5 - 4. After admitting a patient, please check the patient category and make changes appropriately. 5.
Patient Management 5.3.2 Placing a Device in Standby Changing Paced Status It is important to correctly set the patient’s paced status before patient monitoring. You can also set the patient’s paced status from the [ECG] menu. For information regarding how to set paced status, refer to "Checking the Paced Status" on page 7 - 11. 5.3.
Exiting the Standby Mode 5.5 Patient Management Exiting the Standby Mode Press the key to exit Standby mode. After you exit the Standby mode, the system responds as follows: 5.6 ■ Restores parameter measurement as previously configured. ■ Alarm system is activated. ■ The TM80/TM70 notifies the CMS of returning to the Monitoring mode. Discharging the Patient When the TM80/TM70 is connected to the CMS, discharging the patient will stop monitoring at the TM80/TM70 and CMS.
Patient Management 5.6.2 Discharging the Patient Restarting the TM80/TM70 1. If the TM80/TM70 is powered off, press the key to turn on the device. The device prompts whether this is a new patient or not. 2. Select [Yes] to enter the [Discharge Patient] confirmation menu. 3. Select [Yes] to clear the current patient’s configuration and start monitoring by applying the user configuration.
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6 Alarms Introduction...............................................................................................................6-2 Alarm Categories......................................................................................................6-3 Alarm Levels...............................................................................................................6-3 Alarm Indicators .......................................................................................................
Introduction 6.1 Alarms Introduction Alarms, triggered by abnormal vital signs or technical problems, are visually and audibly indicated to the user when the display is on. For the full list of alarm messages displayed at the TM80/TM70, refer to "Troubleshooting" on page 15 - 1. 6.2 Alarm Safety Information WARNING • • • • • • • 6-2 A potential hazard can exist if different alarm presets and default configuration settings are used for the same or similar equipment in the same care area.
Alarms Alarm Categories WARNING • • 6.3 Always make sure that the audio alarm volume level is adequate in your care environment. Always keep the patient under close surveillance. The reception failure of alarm signals may occur in the distributed alarm system. Alarm Categories The alarms can be classified into two categories: physiological alarms and technical alarms. Alarm messages are displayed in the message area on the main screen.
Alarm Indicators 6.5 Alarms Alarm Levels Physiological Alarms Technical Alarms Message Provides additional information on the patient status. Provides additional information on the system status. Alarm Indicators When an alarm occurs, the TM80/TM70 notifies the user through visual or audible alarm indications. ■ Alarm light ■ Audible alarm tones ■ Flashing numerics ■ Alarm message NOTE • 6.5.1 When the display is off, the user must activate the screen to view any local alarms.
Alarms Alarm Indicators ◆ ◆ ◆ ■ High level alarms: Medium level alarms: Low level alarms: high-pitched single beep double beep low-pitched single beep Mode 2: ◆ ◆ ◆ High level alarms: Medium level alarms: Low level alarms: high-pitched triple beep double beep low-pitched single beep NOTE • • 6.5.
Viewing Alarm List 6.5.5 Alarms Alarm Status Symbols The TM80/TM70 still uses the following symbols indicating the alarm status: 6.6 6.7 ■ : indicates that all the alarms are paused. ■ : indicates the technical alarm audio is turned off. ■ : indicates the alarm system is reset. Viewing Alarm List 1. Tap the message area on the main screen. The [Alarm List] menu is displayed. 2. In the [Physiological Alarms] section, you can view the number of physiological alarms and alarm messages. 3.
Alarms Configuring the Alarms NOTE • 6.7.2 When the TM80/TM70 is connected to the CMS, any changes to the alarm properties at the TM80/TM70 or the CMS will be communicated to the other side to make sure that the alarm settings are consistent. Initiating Auto Alarm Limits The TM80/TM70 provides the auto alarm limits function to automatically adjust alarm limits according to the patient’s vital signs used.
Pausing Alarms Alarms Module NIBP 6.7.3 6.8 Lower Limit Upper Limit Adult/ Pediatric Adult/ Pediatric NIBP-S (mmHg) (SYS×0.68 ＋ 10) SYS×0.86 ＋ 38 Adult: 45~270 Pediatric: 45~185 NIBP-D (mmHg) (Dia×0.68 ＋ 6) (Dia×0.86 ＋ 32) Adult: 25~225 Pediatric: 25~150 NIBP-M (mmHg) (Mean×0.68 ＋ 8) Mean×0.86 ＋ 35 Adult: 30~245 Pediatric: 30~165 Parameter Auto Limit Range Restoring the Default Alarm Settings 1. Press the key to enter the main menu. 2. Tap [Alarms]. 3. Tap [Alarm Limits].
