A.10 Electrical Safety Inspection after Repair ................................................................... A-14
A.11 Electrical Safety Inspection Form ................................................................................ A-15
4 BeneVision TM80 Telemetry Monitor Service Manual
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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.
BeneVision TM80 Telemetry Monitor Service Manual 1-1
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1.1.1 WARNINGS
WARNING
The TM80 Telemetry Monitor must be operated by medical personnel
inhospitals or medical institutions.
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.
To avoid explosionhazard, do not use the TM80 Telemetry Monitor in the
presence of oxygen-rich atmospheres, flammable anesthetics, or other
flammableagents.
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.
Do not use the TM80 Telemetry Monitor in conjunction with Electro
SurgicalUnit (ESU).
Do not expose the TM80 Telemetry Monitor to a Magnetic Resonance
(MR) environment.
We recommend that the latest WPA2-PSK security encryption mode
beused when the TM80 Telemetry Monitor is in use.
Auditory alarm signal sound pressure levels that are less than
ambientlevels can impede operator recognition of alarm conditions.
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1.1.2 Cautions
CAUTION
Do not let the display of the TM80 Telemetry Monitor directly touch
thepatient’s skin when the display is on.
When the Central Station presents the alarm”Offline”, check thenetwork
connection status.
When disposing of the packaging material, be sure to observe the
applicablelocal waste control regulations and keep it out of children’s
reach.
Mindray takes no responsibility for controlling the radio frequency
environmentin a hospital. If interference for the operating frequency
oftelemetry equipment exists, the telemetry equipment performance
willbe affected. Exercise caution when selecting the operating frequency
ofall the wireless equipment in a hospital as this is very important to
avoidmutual interference among them.
Magnetic and electrical fields are capable of interfering with the
properperformance of the TM80 Telemetry Monitor. For this reason make
surethat all external equipment operated in the vicinity of the TM80
TelemetryMonitor 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
electromagneticradiation.
BeneVision TM80 Telemetry Monitor Service Manual 1-3
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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
The software of the TM80 Telemetry Monitor was developed in
compliancewith IEC60601-1-4. The possibility of hazards arising from
softwareerrors is minimized.
This manual describes all features and options. Your equipment may
nothave all of them.
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.
1-4 BeneVision TM80 Telemetry Monitor Service Manual
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2 Overview
2.1 Product Overview
The TM80 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 TM70. The TM70 telemetry monitor is intended for use in
professional healthcare facilities under the direct supervision of a licensed
healthcare practitioner.
The TM80 telemetry monitor can only be admitted by the Central Monitoring
System (CMS) whose version is 03.00 or above.
WARNING
The TM80 Telemetry Monitormust be operated by medical personnel
inhospitals or medical institutions.
The TM80 Telemetry Monitor is not designed for monitoring critically
illpatients.
As the TM80 Telemetry Monitortransmits data wirelessly, there mightbe a
risk of data loss.
The TM80 Telemetry Monitorcan 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 batterycan
cause a battery to overheat during use.
High temperatures can cause burns to the TM80. Refer to BeneVisionTM80
BeneVision TM80 Telemetry Monitor Service Manual 2-1
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Telemetry Monitor Operator’s Manual for the maintenance methods.
WARNING
Before maintaining and repairing the TM80 Telemetry Monitor, familiarize
yourself with the BeneVisionTM80 Telemetry Monitor Operator’s Manual.
2.2 Key Features
Easy for clinicians to use and comfortable for patients to wear
Low power consumption
Supports IEEE 802.11a/b/g/n/ac and 2.4GHz/5Ghz dual Wi-Fi band
Able to be accessed to the existing wireless networks in a hospital directly
2.3 Introduction to TM80 Telemetry Monitoring System
The TM80 Telemetry Monitor 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 SpO
the SpO
sensor connector and then plugged into the SpO2connector on
2
modules. The SpO2module is connected to
2
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 3Installation.
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Telemetry Monitoring system
Transmission
system
AP arrayCMS
Receive data
Data analysis
Data management
Information display
Collect and upload ECG/SpO2/
NIBP/RESP parameters
Local alarm
Local storage and review
Upload data
ECG
Yes / Resp
Yes / SpO2
/
Yes
NIBP / Yes
The CMS refers to BeneVision Central Monitoring System. For details about
the Benevision Central Monitoring System, refer to BeneVision Central
Monitoring System Operator’s Manual (P/N H-046-010879-00).
The following figure shows relationships among the subsystems.
2.3.1 Module Configurations for the TM80 Telemetry Monitor
The table below shows the ECG, Resp, SpO2, and NIBP configuration status for the
TM80 Telemetry Monitor.
Parameter Standard Optional
2.3.2 Connection Diagram of the TM80 Telemetry Monitor
The following figures illustrates how the ECG, SpO2, and NIBP modules are
connected to the TM80 Telemetry Monitor.
BeneVision TM80 Telemetry Monitor Service Manual 2-3
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ECG/RESP
collection
TM80
Telemetry
Monitor
SpO2 module
NIBP
measurement
Wired connection
Wireless
connection
The ECG and Resp collection circuit is designed inside the TM80 Telemetry Monitor.
The SpO
to the TM80 Telemetry Monitor via the SpO
module and sensor constitute a SpO2 cable. The SpO2 module is connected
2
cable.
2
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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AP
AP
...
100
/1000
Mbps Switch
WLAN
802
.
11
a
/b
/g
/
n/ac
...
Network
AP
AP
...
100/
1000Mbps Switch
WLAN
802
.
11a
/
b
/
g
/
n/ac
...
...
CMS
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.
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
CMS, the information is displayed, stored and processed based on a certain
algorithm and alarms are generated. 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 in the
ViewBed window of the CMS.
BeneVision TM80 Telemetry Monitor Service Manual 2-5
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FOR YOUR NOTES
2-6 BeneVision TM80 Telemetry Monitor Service Manual
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3 Installation
3.1 Overview
3.1.1 Introduction
TheTM80 Telemetry Monitor (hereinafter called TM80) exchanges data with the CMS
via Wi-Fi network. Wi-Fi communication is the core function of the TM80. This
chapter guides users to use the Wi-Fi communication function properly and reliably.
WARNING
To ensure reliable operation of the TM80 wireless network, deploy the
network in strict accordance with relevant requirements in this manual and
keep maintaining the network properly after installingthe TM80. If the
network is not deployed according to this manual, data transmission of the
TM80 may be delayed, or even be lost, thus resulting in clinical risks.
CAUTION
Customers are responsible for network management. Changing network
after installation may deteriorate the performance of the TM80.
Therefore, customers need to sufficiently assess network change so as to
avoid impact on clinical use of the TM80.
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3.1.2 Business Types
The WLAN deployment requires certain techniques and accumulation of experience.
On the market, professional communication technical service companies such as
local agents of Cisco implement the engineering in most cases. Mindray
recommends hospitals to choose the third-party engineering deployment agencies
to complete network environment deployment in preference.
Three processing modes are provided for different circumstances:
The hospital has built its WLAN: Mindray defines specification requirements and
acceptance methods, inspects the hospital by sending field engineers to the
hospital and confirms the requirements on site. If the hospital’s network
cannot meet deployment requirements of the TM80, Mindray informs the
hospital of possible consequences such as disconnection and requires the
hospital to rectify the WLAN according to requirements of Mindray.
The hospital builds a new WLAN to cover areas greater than 2000 square meters
for the TM80, and IT requirements are complex: Mindray recommends that a
third-party construction organization carries out construction and completely
uses the network devices and configurations developed and verified by
Mindray. Mindray defines specification requirements and acceptance methods,
inspects the hospital by sending field engineers to the hospital and confirms
the requirements on site after the construction organization completes
confirmation. The third-party construction organization must have: documents
of detailed internal construction specifications (including construction process,
safety precautions, and construction process inspection checklist) and
successful engineering cases in schools, hotels, and even hospitals of similar
scale.
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The hospital builds a new WLAN to cover areas less than 2000 square meters for
the TM80 and there are no other requirements except for connection to
Mindray monitors: Mindray contacts the construction organization and
completely uses the network devices and configurations developed and
verified by Mindray. Mindray defines specification requirements and
acceptance methods, inspects the hospital by sending field engineers to the
hospital and confirms the requirements on site. Compared with the previous
circumstance, Party A for network deployment engineering is changed from
the hospital to Mindray. Mindray needs to play a greater role in supervision.
This chapter focuses on wireless network deployment requirements. The
architecture and configuration requirements of Mindray’s wired network are
described in another document.
BeneVision TM80 Telemetry Monitor Service Manual 3-3
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Mindray/agent
marketing or sales
personnel
Mindray
headquarters
Mindray/agent
service personnel
A1 Communicate with
the hospital about
intention to order
A5 Install the device
and confirm system
operation
A6 Accept and confirm
with the hospital
A0 Provide network
requirements
A2 Communicate with the
hospital about network
requirements and ask the
hospital to perform
corresponding setting and
adjustment
Pass or fail
Pass
A4 Sign the contract
A3 Do site survey
3.1.3 Installation Process
3.1.3.1 Using Hospital’s WLAN
If the hospital has built its WLAN, the installation process is illustrated as follows:
3-4 BeneVision TM80 Telemetry Monitor Service Manual
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network
List of outputs
Action Output Requirements Template
A0
Basic
requirements
for
Determine specific
requirements for deployment
of the TM80 network.
3.11.1TM80 Wi-Fi
Network
Requirement Table
deployment of
the TM80
A3 Environmental
survey report
Confirm that the wireless
environment of the customer
3.11.2Environmental
Survey Table
meets requirements of the
TM80 by means of
questionnaire and
measurement.
A5 Network
acceptance
report
Confirm that the customer
network meets requirements
of the TM80 by means of
3.11.3Network
Acceptance Table
questionnaire and
measurement.
A6
Sample
verification
confirmation
Confirm the actual operation
of the sample after the sample
is installed.
3.11.4TM80
Verification
Confirmation Table
table
CAUTION
If the customer network cannot meet the requirement in
3.11.2Environmental Survey Table, the service personnel should perform
pilot run of the TM80 for at least 24 hours first to ensure that the wireless
environmentis compatible before signing a contract.
BeneVision TM80 Telemetry Monitor Service Manual 3-5
Page 28
NOTE
Contents in 3.11.2Environmental Survey Table are actually part of
3.11.3Network Acceptance Table. If service personnel have already
performed environmental survey, they can fill the survey results in the
Network Acceptance Tabl e directly.
3.1.3.2 Installing New WLAN for TM80
If the hospital plans to build a new WLAN for the TM80, make sure that there is at
least one idle wifi channel that is not in use. Otherwise, you can’t make Co-channel
interference meet TM80’s requirement after the new WLAN is built. The installation
process is illustrated as follows:
3-6 BeneVision TM80 Telemetry Monitor Service Manual
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network
Mindray/
agent
marketing or s
ales
personnel
Mindray
headquarters
Mindray
/agent
service personnel
A1 Communicate with
the hospital about
intention to order
A5 Install the device
and confirm system
operation
A6
Accept and confirm
with the hospital
A
0 Provide network
requirements
A
4 Install network
A2 Do site survey and
design network
A
3 Sign the contract
List of outputs
Action Output Requirements Template
Basic
A0
A2 Network design
requirements
for deployment
of the TM80
Determine specific
requirements for deployment
of the TM80 network.
/ /
3.11.1TM80 Wi-Fi
Network
Requirement
Table
document,
Bill of material
A5 Network
BeneVision TM80 Telemetry Monitor Service Manual 3-7
acceptance
Confirm that the installed
network meets requirements of
3.11.3Network
Acceptance Table
Page 30
report
the TM80 by means of
self-check and measurement.
A6
Sample
verification
confirmation
table
Confirm the actual operation of
the sample after the sample is
installed.
3.11.4TM80
Verification
Confirmation
Table
NOTE
This manual only shows a reference for installing new WLAN for TM80 in
section 3.7. Network deployment project needs much more complex
process, you need professional IT engneer ’s help to finish the job.
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3.2 Network Requirements of the TM80
The TM80 transmits vital signs of patients in real time. The requirements for
real-time and reliability are higher than those for audio and video services. The TM80
is powered by a battery. It adopts low power Wi-Fi technology. Therefore, the
network needs to meet specific requirements to ensure reliable operation.
The network requirements of TM80 can be classified into six types:
Wireless coverage
AP capability and compatibility
WLAN features
EAP Requirement for RADIUS Server and Certs
Network service and VLAN
Some important settings of network device
The first four types are decided by infrastructure of network. They can’t be modified
easily. If the network does not meet the requirements before TM80 is installed,
network dropping-off may happen easily after installation.
The fifth and sixth types belong to configuration of network. They need hospital IT
department’s help to achieve. According to experience of Mindray, the two types
can guarantee reliable performance of TM80 effectively. If any requirement is not
met, network dropping-off may happen in certain situation. If the number of
devices using the same network is small, and no device needs high wireless
bandwidth, the possibility of dropping-off can be reduced.
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3.2.1 Requirements for Network Feasibility
Before installing TM80 telemetry monitors, it is very important to confirm network
feasibility.
Wireless coverage, WLAN features and AP capability and compatibility are decided
by infrastructure of network, infrastructure of network can’t be modified easily. If the
network does not meet the requirements before TM80 is installed, network
dropping-off may happen easily after installation.
3.2.1.1 Requirements for the Wireless Coverage
The wireless coverage must be well controlled to ensure that TM80 can achieve the
maximum data-rate and the lowest packet loss ratio. TM80 data is real-time
upstream data streams and is similar to VoIP data. Monitoring data carries real-time
physiologic information about patients. Therefore, reasonable wireless coverage
must be provided for monitors. In particular, because the telemetry device TM80 is
worn on human body, the signal may become poorer due to blocking of human
body.
The requirements of the TM80 for wireless coverage are as follows:
No. Item Requirements of the TM80 Description
1 Received
signal
strengths
(RSSI)
2 Co-channel
interference*
3 Ping delay The mean delay of PC or cell phone
3-10 BeneVision TM80 Telemetry Monitor Service Manual
≥-65 dBm
Signal coverage requirement for APs
connected to the TM80: RSSI value
displayed on the TM80
≤-20dB
Measured on the same channel of
the TM80
with normal wifi module is smaller
than 100ms and the packet lost rate
The requirement
must be met.
The requirement
must be met.
The requirement
must be met.
Page 33
No. Item Requirements of the TM80 Description
shall be less than 1%.
Co-channel interference is the most obvious interference for Wi-Fi. The signal
strength of the nearest AP perceived by the wireless monitor must be 20 dB higher
than that of other APs on the same channel. Take 2.4 GHz band as an example. The
following channel deployment is recommended to realize Wi-Fi coverage similar to
cellular coverage.
For co-channel interference, the interference between floors needs to be considered
and the following case should be avoided: a pair of APs is set nearby between two
floors and is working on the same channel. Different SSIDs of the same AP do not
generate co-channel interference (CCI) . CCI from different AP but Same SSID can be
accepted in 2.4G band, but this is highly recommended to be avoided.
3.2.1.2 Requirements for the AP capability
Because the low-power WIFI module is sleeping periodically and the capability for
dealing with wireless data is reduced, it is necessary to use high-performance AP to
BeneVision TM80 Telemetry Monitor Service Manual 3-11
Page 34
enhance the stability of total system. Mindray tested a lot with TM80 and Cisco APs,
the compatibility of Cisco AP is proven good.
We recommend using the network equipment verified by Mindray. This verification
activity includes confirmation of network architecture, equipment model, firmware
version, and specific configurations.
If network equipment whose compatibility is not confirmed by Mindray is used,
potential risks may exist during operation of the TM80. In this case, Mindray
recommends the customer to perform pilot run of the TM80 for at least 24 hours
first to ensure that the equipment is compatible.
Device density needs to be controlled. If too many devices are mounted under one
AP, competition among devices becomes fiercer. For low power consumption Wi-Fi,
high data loss probability will be caused. Therefore, the number of devices under
the same AP must be controlled. The TM80 requires one AP to mount a maximum of
16 devices.
No. Item Requirements of the TM80 Description
1 Recommended
AP
Mindray’s recommendations:
Cisco: WLC 2504 (version 7-4-121-0 or
Nice to meet
later) + LAP: 2802 or 2602
or FAT AP:2602
Aruba:7500 series+LAP:APIN0205
Netgear:WNDAP350
Notes: If the AP is 2802 or
WNDAP350,TM80 can only use 5G
2 AP capability 1.The anticipated number of devices
connecting to one AP must be
lower than the AP capability ,and
The
requirement
must be met.
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No. Item Requirements of the TM80 Description
capability should has a margin of
50%. For example, In the coverage of
one AP, the typical number of devices
connected to this AP is 16, then the
announced number of devices than
can connect to AP simultaneously
must be more than 32.
2. The AP Can create several SSIDs.
3 Device density The maximum number of devices
connected to one AP simultaneously
is 16 (including TM80 and other
devices).
4 AP
compatibility
When customer using APs not from
Cisco, compatibility test should be
passed
The
requirement
must be met.
The
requirement
must be met.
3.2.1.3 Requirements for WLAN Features
The requirements of the TM80 for WLAN features are as follows. If WLAN is of other
features, e.g. using 802.11ac, TM80 will not support, and can't connect to network.
The TM80 adopts low power consumption Wi-Fi technology. If the amount of
broadcast or multicast data is too large on the network, the device wake-up time
increases, the standby duration is shortened, and even Wi-Fi transmission
interruption is caused. Therefore, the TM80 must use an independent VLAN and
work in a different network segment from the CMS, so as to control the amount of
broadcast data. An AP can be configured with multiple SSIDs and associated with a
VLAN. The TM80 needs to use an independent SSID.
BeneVision TM80 Telemetry Monitor Service Manual 3-13
Page 36
No. Item Requirements of the TM80 Description
1 802.11
protocol
2 Security
mode
TM80 only support 802.11 a/b/g/n,
WLAN can't use other protocols
TM80 supports:
WPA/WPA2-PSK or WPA2-Enterprise
EAP method:
PEAP-GTC, PEAP- MSCHAPv2,EAP-TLS
WPA2-PSK is highly recommended.
WPA2-Enterprise may increase
probability of offline when roaming, so
not be recommended.
WLAN can't use other security mode.
3 AP MAC
address
The broadcast MAC address of AP is
fixed (BSSID).
AP BSSID is used to locate the TM80
device. If it is changed, failure to locate
the TM80 may occur.
4 AP channel
width
If the AP supports 802.11n/ac, set the
channel width to 20Mhz, don’t use HT40
or even HT80.
5 Dedicated
VLAN
The TM80 needs to work on a dedicated
VLAN.
Using VLAN can minimize Broadcast or
multicast data which can affect TM80
stability.
The requirement
must be met.
The requirement
must be met.
The requirement
must be met.
The requirement
must be met.
The requirement
must be met.
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TLS_RSA_WITH_RC4_128_MD5
TLS_RSA_WITH_RC4_128_MD5
Free
PEAP-MSCHAPV
TLS_ECDHE_RSA_WITH_AES_128_CBC_SH
3.2.1.4 EAP Requirements for RADIUS Server and Certs
RADIUS Server
The following RADIUS Server is validated by Mindray:
Cisco ACS
FreeRADIUS
Network Policy Service( in Windows Server 2008 R2 and Windows Server 2012 R2)
Algorithm
The following table list the EAP methods and TLS1.0 algorithm that TM80 supported