BeneVision TM80 Service Manual Rev 7.0 April 2019

Revision History This manual has a revision number. This revision number changes whenever the manual is updated due to software or technical specification change. Contents of this manual are subject to change without prior notice.



Revision number: 6.0



Release time: April 2019

©2015-2019 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. All rights reserved.

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TM80 Telemetry Monitor Service Manual

Preface Manual Purpose This manual provides detailed information about the assembling, dissembling, testing and troubleshooting of the equipment to support effective troubleshooting and repair. It is not intended to be a comprehensive, in-depth explanation of the product architecture or technical implementation. Observance of the manual is a prerequisite for proper equipment maintenance and prevents equipment damage and personnel injury. This manual is based on the maximum configuration. Therefore, some contents may not apply to your device. If you have any question, please contact our Customer Service Department.

Intended Audience This manual is for biomedical engineers, authorized technicians or service representatives responsible for troubleshooting, repairing and maintaining theTM80 Telemetry Monitors.

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Table of Contents 1 Safety ... 1-1 1.1 Safety Information ... 1-1 1.1.1 WARNINGS ... 1-2 1.1.2 Cautions ... 1-3 1.1.3 Notes ... 1-4 1.2 Equipment Symbols ... 1-4 2 Overview ... 2-1 2.1 Product Overview ... 2-1 2.2 Key Features ... 2-2 2.3 Introduction to TM80 Telemetry Monitoring System ... 2-2 2.3.1 Module Configurations for the TM80 Telemetry Monitor ... 2-3 2.3.2 Connection Diagram of the TM80 Telemetry Monitor ... 2-4 2.4 Architecture of the TM80 Telemetry Monitoring System... 2-5 3 Installation ... 3-1 3.1 Configuring WLAN Settings of TM80 ... 3-1 3.1.1 WLAN Setup ... 3-3 3.1.2 EAP Setup ... 3-4 3.1.3 EAP Certificate Management ... 3-5 3.1.4 WLAN TEST ...3-13 4 Product Principles... 4-1 4.1 System Composition ... 4-1 4.2 System Signal Flow ... 4-4 5 Testing and Maintenance ... 5-1 5.1 Recommended Maintenance and Test Frequency... 5-2 5.2 Inspection before Daily Use ... 5-2 5.3 Preventative Maintenance Procedures ... 5-3

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5.4 Parameter Performance Test ... 5-3 5.4.1 ECG Tests ... 5-3 5.4.2 Resp Test ... 5-5 5.4.3 SpO2Test ... 5-6 5.4.4 NIBP Tests ... 5-7 5.5 Miscellaneous Tests ...5-11 5.5.1 Visual Inspection ...5-11 5.5.2 Power-On Test ...5-11 5.5.3 Nurse Call Test ...5-12 5.5.4 Electric Safety Test ...5-12 5.5.5 Network Print Test ...5-12 5.5.6 Battery Check ...5-13 6 Hardware Upgrade ... 6-1 6.1 Adding the SpO2 Function ... 6-1 6.2 Adding the NIBP Module (BP10) ... 6-1 6.3 Adding the Number of the TM80 Telemetry Monitors ... 6-2 6.4 Extending Coverage ... 6-3 7 Software Upgrade... 7-1 7.1 List of Upgradeable Software Items ... 7-1 7.2 Preparation before Upgrade ... 7-1 7.2.1 Required Tools ... 7-1 7.2.2 Making an Upgrade USB Drive ... 7-2 7.3 Upgrade Procedures ... 7-2 7.4 Verification after Upgrade ... 7-3 8 Troubleshooting ... 8-1 8.1 Common Faults ... 8-1 8.1.1 The TM80 Failed to Connect to the Central Station ... 8-1 8.1.2 The TM80 Are Offline Frequently... 8-2 8.1.3 The TM80 Cannot Be Powered On ... 8-2

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TM80 Telemetry Monitor Service Manual

8.1.4 The Working Duration of Battery Becomes Short ... 8-3 8.2 Technical Alarms ... 8-3 8.3 Other Faults ...8-12 8.4 Error Codes ...8-17 9 Disassembly ... 9-1 9.1 Overview ... 9-1 9.2 Disassembling the TM80 ... 9-2 9.3 Disassembling the BP10 ... 9-9 10 Maintenance Materials ... 10-1 10.1 Overview of Maintenance Materials ...10-1 10.2 TM80 Front Housing Assembly (WI-FI) ...10-2 10.3 TM80 Rear Housing Assembly (WI-FI) ...10-3 10.4 TM80 Main Unit (WI-FI) ...10-5 10.5 BP10 Front Housing Assembly ...10-6 10.6 BP10 Rear Housing Assembly ...10-7 10.7 BP10 Main Unit ...10-8 A Electrical Safety Inspection ... A-1 A.1 Electrical safety tests for the TM80 and BP10, central charger ... A-1 A.2 Power Cord Plug ... A-2 A.3 Device Enclosure and Accessories ... A-3 A.4 Device Labeling ... A-4 A.5 Earth Leakage Test ... A-4 A.6 Patient Leakage Current ... A-6 A.7 Mains on Applied Part Leakage ... A-9 A.8 Patient Auxiliary Current ... A-12 A.9 Scheduled Electrical Safety Inspection ... A-14 A.10 Electrical Safety Inspection after Repair ... A-14 A.11 Electrical Safety Inspection Form ... A-15

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1 Safety 1.1 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 

Provides application tips or other useful information.

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1.1.1 WARNINGS WARNING 

The TM80 Telemetry Monitor must be operated by medical personnel inhospitals or medical institutions.

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For continued safe use of the TM80 Telemetry Monitor, the instructionsgiven in this manual must be followed. But instructions in this manual inno way supersede established medical procedures.

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To avoid explosionhazard, do not use the TM80 Telemetry Monitor in the presence of oxygen-rich atmospheres, flammable anesthetics, or other flammableagents.

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The TM80 Telemetry Monitor is not to be used in the vicinity of electrosurgicalunits because such use may interrupt or interfere with thetransmission of signals from the TM80 Telemetry Monitor.

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Do not use the TM80 Telemetry Monitor in conjunction with Electro SurgicalUnit (ESU).

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Do not expose the TM80 Telemetry Monitor to a Magnetic Resonance(MR) environment.

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We recommend that the latest WPA2-PSK security encryption mode beused when the TM80 Telemetry Monitor is in use.

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Auditory alarm signal sound pressure levels that are less than ambientlevels can impede operator recognition of alarm conditions.

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TM80 Telemetry Monitor Service Manual

1.1.2 Cautions CAUTION 

Do not let the display of the TM80 Telemetry Monitor directly touch the patient’s skin when the display is on.

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When the Central Station presents the alarm”Offline”, check the network connection status.

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When disposing of the packaging material, be sure to observe the applicable local waste control regulations and keep it out of children’s reach.

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Mindray takes no responsibility for controlling the radio frequency environmentin a hospital. If interference for the operating frequency of telemetry equipment exists, the telemetry equipment performance willbe affected. Exercise caution when selecting the operating frequency of all the wireless equipment in a hospital as this is very important to avoid mutual interference among them.

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Magnetic and electrical fields are capable of interfering with the proper performance of the TM80 Telemetry Monitor. For this reason make sure that all external equipment operated in the vicinity of the TM80 Telemetry Monitor comply with the relevant EMC requirements. Mobile phone,X-ray equipment, micro-wave oven, interphone, or MRI equipment are apossible source of interference as they may emit higher levels of electromagnetic radiation.

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1.1.3 Notes NOTE 

Put the TM80 Telemetry Monitor in a location where you can easily seethe screen and access the operating controls

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The software of the TM80 Telemetry Monitor was developed in compliance with IEC60601-1-4. The possibility of hazards arising from software errors is minimized.

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This manual describes all features and options. Your equipment may not have all of them.

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Keep this manual in the vicinity of the equipment so that it can be obtained conveniently when needed.Provides application tips or other useful information.

1.2 Equipment Symbols See BeneVision TM80 Telemetry Monitor Operator’s Manual for information about the symbols used on this product and its packaging.

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TM80 Telemetry Monitor Service Manual

2 Overview 2.1 Product Overview The TM80 Telemetry Monitors intended for use on ambulatory adult and pediatric patients to monitor the physiological data of ECG (including arrhythmia analysis and ST segment analysis), heart rate (HR), Resp, SpO2, pulse rate (PR), and non-invasive blood pressure (NIBP). The NIBP module BP10 also supports 24-hour dynamic blood pressure measurement for adult and pediatric patients and the measurement results serve as reference for medical staff.

WARNING 

The TM80 Telemetry Monitor must be operated by medical personnel inhospitals or medical institutions.

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The TM80 Telemetry Monitor is not designed for monitoring critically illpatients.

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As the TM80 Telemetry Monitor transmits data wirelessly, there mightbe a risk of data loss. The TM80 Telemetry Monitor should not be used for primary monitoring in applications where momentary loss of the ECG is unacceptable at the Central Station.

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The TM80 Telemetry Monitor can be powered by a rechargeable lithium-ion battery (P/N 022-000196-00 )or three AA batteries (P/N 0000-10-10902).Misuse or improper maintenance of the rechareable lithium-ion battery can cause a battery to overheat during use. High temperatures can cause burns to the TM80. Refer to Chapter 14 Battery of BeneVision TM80 Telemetry Monitor Operator’s Manual (P/N 046-007479-00) for the maintenance methods.

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WARNING 

Before maintaining and repairing the TM80Telemetry Monitor, familiarize yourself with the BeneVision TM80 Telemetry Monitor Operator’s Manual.

2.2 Key Features 

Easy for clinicians to use and comfortable for patients to wear

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Low power consumption

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Supports IEEE 802.11a/b/g/n/ac and 2.4GHz/5Ghz dual WI-FI band

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Able to be accessed to the existing wireless networks in a hospital directly

2.3 Introduction to TM80 Telemetry Monitoring System The TM80 Telemetry Monitoring System consists of a transmission system, a receiving system, and a central monitoring system (abbreviated as CMS). The transmission system refers to the TM80 Telemetry Monitor with optional BP10 and SAT10 SpO2 modules. The SpO2module is connected to the SpO2sensor connector and then plugged into the SpO2connector on the TM80.The BP10 is a standalone module and communicates with the TM80 via Mindray Patient Area Network (abbreviated as MPAN). 

The receiving system refers to the WI-FI network, including APs, switches, and routers. The TM80 can use the dedicated WI-FI network provided by Mindray or share the hospital’s network with other devices in the hospital. The network must comply with the wireless specifications of Mindray. For details of specifications, refer to TM80 WiFi Network Installation Guide(Dedicated Network) (PN: 046-013948-00) and TM80 Wifi Network Installation Guide(Co-exist Network) (PN: 046-013950-00).

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TM80 Telemetry Monitor Service Manual

The CMS refers to BeneVision Central Monitoring System. For details about the Benevision Central Monitoring System, refer to BeneVision Central Monitoring SystemOperator’s Manual (P/N: 046-007687-00).

The following figure shows relationships among the subsystems. Telemetry Monitoring system

Transmission system Collect and upload ECG/SpO2/ NIBP/RESP parameters Local alarm Local storage and review Upload data

CMS

AP array

Data analysis Data management Information display

Receive data

2.3.1 Module Configurations for the TM80 Telemetry Monitor The table below shows the ECG, SpO2, and NIBP configuration status for the TM80 Telemetry Monitor. Parameter

Standard

Optional

ECG

Yes

/

SpO2

/

Yes

Resp

/

Yes

NIBP

/

Yes

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2.3.2 Connection Diagram of the TM80 Telemetry Monitor The following figures illustrates how the ECG, Resp, SpO2, and NIBP modules are connected to the TM80 Telemetry Monitor.

SpO2 module Wired connection ECG/RESP collection

Wireless connection

TM80 Telemetry Monitor

NIBP measurement

The ECG and Resp collection circuit is designed inside the TM80 Telemetry Monitor. The SpO2 module and sensor constitute a SpO2 cable. The SpO2 module is connected to the TM80 Telemetry Monitor via the SpO2 cable. Hard connection is used between the cable and the monitor. The NIBP module is a standalone module and performs short-range wireless communication with TM80 Telemetry Monitor.

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TM80 Telemetry Monitor Service Manual

2.4 Architecture of the TM80 Telemetry Monitoring System The following figure illustrates the physical units of the TM80 Telemetry Monitoring System. It shows how these devices and functional units are interconnected to form a complete telemetry monitoring system.

CMS

Network WLAN

WLAN

802.11 a/b/g/n/ac

802.11a/b/g/n/ac

100/1000Mbps Switch

100/1000Mbps Switch

... AP

AP

...

...

... AP

AP

...

The TM80 Telemetry Monitors are worn on patients. As shown in the figure above, patients’ physiological information collected by the TM80 Telemetry Monitors is transmitted through the low power consumption WI-FI modules built in the telemetry monitors. Wireless signals are acquired by AP arrays and then are transmitted to the CMS through the existing network system of the hospital. On the TM80, the information is displayed, stored and processed based on a certain algorithm. Alarms can be generated locally and the data is sent to CMS. TM80 Telemetry Monitor Service Manual

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In addition, patients can seek for help from nurses on the CMS side by using the nurse call function. When a TM80 Telemetry Monitor is connected to the CMS, doctors can view its patient information on the ViewBed screen of the CMS.

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TM80 Telemetry Monitor Service Manual

3 Installation The TM80 Telemetry Monitor (hereinafter called TM80) exchanges data with the CMS via WIFI network. WIFI communication is the core function of the TM80. For details of how to use the WIFI communication function properly and reliably, refer to TM80 WiFi Network Installation Guide(Dedicated Network)(PN: 046-013948-00) and TM80 Wifi Network Installation Guide(Co-exist Network)(PN: 046-013950-00).

3.1 Configuring WLAN Settings of TM80 This table lists the items that need to be configured to make proper operation of the TM80. Item

Description

Remarks

Main Menu->Maintenance->Networ k->IP Address Setup

Set static IP address or DHCP

Main Menu -> Maintenance->Network-> WALN Setup

Configure SSID, password, EAP, etc.

Main Menu -> Maintenance ->Network->Connect CMS

Configure how to connect to the CMS.

For details, please refer to BeneVision TM80 Telemetry Monitor Operator’s Manual. For details, please refer to BeneVision TM80 Telemetry Monitor Operator’s Manualand3.1Configurin g WLAN Settings of TM80in this manual For details, please refer to BeneVision TM80 Telemetry Monitor Operator’s Manual. If CMS and TM80 are not in the same subnet, multicast TTL should be greater than 1. It is recommended to set Qos to High.

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Item

Description

Remarks

Main Menu -> Maintenance->Network-> Wireless Setup

Select to use 2.4G band or 5G band

Main Menu -> Maintenance->Network->EAP Certificate

Manage CA certificates and user certificates

Main Menu->Maintenance ->Service-> WLAN test->Roaming Test

Configure roam parameters that will affect TM80’s roaming performance Set the region where the TM80 will be used

5G band is highly recommended. If 2.4G is selected, the TM80 can only roam between 2.4G channels, but never goes to 5G channels. For details, please refer to BeneVision TM80 Telemetry Monitor Operator’s Manual and 3.1.2 EAP Setup in this manual. For details, refer to 3.1.4.4 Roaming Test.

Main Menu->Maintenance->Service ->WLAN test->WI-FI Regulatory domain

For details, refer to3.1.4.3 WI-FI Regulation Domain.

NOTE 

After changing the settings in Main Menu ->Maintenance->Service, reboot TM80 to make sure these settings take effect

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TM80 Telemetry Monitor Service Manual

3.1.1 WLAN Setup 1.

Press

to enter the main menu.

2.

Tap Maintenance→ enter the required password → tap Network→ tap WLAN Setup.

3.

Enter a network name for Network Name.

4.

Set Security Type to WPA/WPA2 PSK, WPA/WPA2 EAP or WPA/WPA2 CCKM.

Some important information for security types: Security Type of TM80

WPA/WPA2 PSK

WPA/WPA2 EAP

Compatible Security Type of AP WPA with AES WPA with TKIP WPA with AES+TKIP WPA2 with AES WPA2 with AES+TKIP WPA2 with AES WPA2 with AES+TKIP EAP method: LEAP, TTLS, TLS, FAST, PEAP-MsChapV2, PEAP-GTC,

Remarks

Do not use WPA2 with TKIP

Do not use WPA. Do not use WPA2 with TKIP

PEAP-TLS

WPA/WPA2 CCKM

WPA2 with AES WPA2 with AES+TKIP EAP method: LEAP, TTLS, TLS, FAST, PEAP-MsChapV2, PEAP-GTC, PEAP-TLS

TM80 Telemetry Monitor Service Manual

Do not use WPA. Do not use WPA2 with TKIP

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3.1.2 EAP Setup 1.

Press

to enter the main menu.

2.

Tap Maintenance→ enter the required password → tap Network→ tap WLAN Setup.

3.

Enter a network name for Network Name.

4.

Set Security Type to WPA/WPA2 EAP.

5.

Select the desired EAP method. Then items related to this EAP method will be displayed. Different items need to be configured for corresponding EAP method.

This table shows correspondence between EAP method and Configuration Items. Name

Security method EAP-TLS

EAP-TTLS

EAP-PEAP

EAP-LEAP

EAP-FAST

ssid

M

M

M

M

M

identity

M

M

M

M

M

password

-

M

M

M

M

ca_cert(*1)

M

M

M

-

-

client_cert

M

-

-

-

-

private_key

M

-

-

-

-

private_key_passwd

M

-

-

-

-

anonymous_identity

-

O

O

-

O(*2)

phase1

-

-

M

-

-

phase2

-

M

M

-

-

pac_file

-

-

-

-

M

pac_bin

-

-

-

-

M

pac_bin_passwd

-

-

-

-

O

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