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GE Healthcare

Addendum for CARESCAPE Monitor B650 service


manual
Networking disclosure to facilitate network risk
management

Addendum for CARESCAPE Monitor B650


service manual
English
2nd edition
2106778-009 paper
© 2018 General Electric Company.
All rights reserved.
Due to continuing product innovation, specifications in this manual are subject to change without notice.
For technical documentation purposes, the abbreviation GE is used for the legal entity names, GE Medical Systems Information Technologies,
Inc. and GE Healthcare Finland Oy.

2 Addendum for CARESCAPE Monitor B650 service manual 2106778-009


2018-04-27
Contents
Purpose and scope ....................................................................................... 5
Purpose of the CARESCAPE Monitor B650 connection to a
network.......................................................................................................... 5
CARESCAPE Monitor B650 network interface technical
specifications ................................................................................................ 5
Network information flows........................................................................... 7
Required characteristics and configuration of the network for support
of the CARESCAPE Monitor B650.................................................................. 13
Potential risks to safety, effectiveness, or security resulting from
failure of IT network to provide the required characteristics ..................... 13

2106778-009 Addendum for CARESCAPE Monitor B650 service manual 3


4 Addendum for CARESCAPE Monitor B650 service manual 2106778-009
Purpose and scope
This disclosure provides manufacturer’s instructions for connecting the CARESCAPE
Monitor B650 to the responsible organization’s IT network. It is intended to satisfy the
requirements of IEC 60601-1:2012 clause 14.13 and IEC/ISO 80001-1:2010 clause 3.5
for disclosure of network-related specifications, requirements, and residual risks in
order to facilitate the responsible organization’s risk management activities (e.g.,
pursuant to 80001-1) for their networks incorporating the CARESCAPE Monitor B650.

Purpose of the CARESCAPE Monitor B650


connection to a network
The CARESCAPE Monitor B650 is intended to be connected to a network in order to
support the following functionality:
● Providing real-time patient data (such as parameters, waveforms and alarms) to
compatible network devices such as central stations or other bedside monitors.
● Remote viewing of 12SL ECG reports at compatible network devices.
● Remote configuration (patient admission, alarm settings, etc.) from compatible
network devices.
● Remote service diagnostics and configuration (Webmin/InSite).
● Printing to a compatible network printer.

CARESCAPE Monitor B650 network interface


technical specifications
Connection Name 1 Mission critical (MC) network port - S/5 network port
Physical network connection IEEE 802.3-1998 10/100BaseT Ethernet
type
Speeds and duplex modes 10 Mbps half duplex
supported
Default IP Address (from MC:
factory) IP address — 172.16.x.y
NOTE: x and y are equal to the last two octets of the MAC
address.
Subnet mask — 255.255.0.0
Gateway — 172.16.254.254
IP Addressing MC: IPV4 Static
S/5: Virtual Plug ID
QoS Support IP layer DSCP tagging

Connection Name 2 Information exchange (IX) network port


Physical network connection IEEE 802.3-1998 10/100BaseT Ethernet
type
Speeds and duplex modes 10 Mbps half duplex
supported

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Connection Name 2 Information exchange (IX) network port
Default IP Address (from IP address — 172.18.x.y
factory) NOTE: x and y are equal to the last two octets of the MAC
address.
Subnet mask — 255.255.0.0
Gateway — 172.18.254.254
IP Addressing IPv4 Static (default) or DHCP
QoS Support No Markings

Connection Name WLAN


General WLAN 802.11a/b/g
Standards/Certifications ● USA: RF: FCC Part 15.247, 15.407
FCC ID: H9PLA5137C2
● Canada: RF: RSS-210; EMI/EMS: ICES 003 Class B;
IC ID: 1549D-LA5137C2
● North America: EMI/EMS: FCC Part 15
● Radio Equipment Directive 2014/53/EU: EN 300 328
V2.1.1, EN 301 893 V1.8.1, EN 301 893 V2.1.0, EN 301
489-1 V2.1.1, EN 301 489-17 V3.1.1 and the essential
requirements set out in Article 3.1a (health & safety),
Article 3.1b (EMC) and Article 3.2 (radio spectrum use)
● Council Recommendation 1999/519/EC
Antenna Gain 2.4 GHz: -0.1dBi Avg., +0.6dBi Maximum
5 GHz: +0.2dBi Avg., +2.0dBi Maximum
Supported Channel Range 2.4 GHz: 1-14
5 GHz: 34-165
Transmit Power Range 2.4 GHz DSSS and HR/DSSS PHYs: up to +16dBm
2.4 GHz ERP and HT OFDM PHYs: up to +16dBm5 GHz
OFDM and HT OFDM PHYs: up to +16dBm
May be further restricted on some channels according to
regulatory domain
Supported Data Rates (Mbps)
and Corresponding Receive
Sensitivity (dBm), referenced
to antenna conducted
output:
2.4 GHz DSSS and HR/DSSS 1 Mbps/-86, 2 Mbps/-83, 5.5 Mbps/-82, 11 Mbps/-79
(802.11b) PHYs (Sensitivity corresponds to 8% max packet error rate with
1024 byte MPDU.)
2.4 GHz ERP OFDM 6 Mbps -82, 9 Mbps -81, 12 Mbps/-79, 18 Mbps/-77, 24
(802.11g) PHY Mbps/-74, 36 Mbps/-70, 48 Mbps/-66, 54 Mbps/-65
(Sensitivity corresponds to 10% max packet error rate with
1000 byte PSDU.)

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Connection Name WLAN
5 GHz OFDM (802.11a) PHY 6 Mbps/-82, 9 Mbps/-81, 12 Mbps/-79, 18 Mbps/-77, 24 Mbps
-74, 36 Mbps/-70, 48 Mbps/-66, 54 Mbps/-65
(Sensitivity corresponds to 10% max packet error rate with
1000 byte PSDU.)
Wireless Regulatory Domains IEEE 802.11d compliant
Dynamic Frequency 802.11h DFS
Selection
MAC-layer QoS and Power 802.11e HCF-EDCA / EDCF / WMM: Four standard access
Save Support categories plus legacy DCF and customizable CWmin,
CWmax, AIFS and TXOP settings
Data Encryption Support 802.11 WEP, Wi-Fi Protected Access with TKIP (“WPA1”),
802.11i/WPA2 AES-CCMP
Authentication Support None
WEP (128-bit)
WPA-PSK (TKIP)
WPA2-PSK (AES-CCMP)
IP Addressing IPv4, statically configured
IP Layer QoS DSCP tagging per dataflow, 802.11e, WMM

Network information flows


Flow Name 1 Unity Services
Network Connection on MC network
device
Usage Type Clinical
Function Waveforms, parameters, alarms
Purpose Transmit clinical data to other devices on the network
Licensed/optional/required Licensed
Communication Partner Unity Devices/MC Network
Device/IP Address/Network
Middle Layer Protocols UDP
Application Layer Protocol Unity
and Encoding
Ports Standard Unity ports
Traffic characterization and Periodic traffic.
Bandwidth Requirements Incoming unicast traffic is approximately 50 Kbps if viewing
a remote bed.
Outgoing unicast traffic is approximately 50 Kbps per patient
view.
Outgoing broadcast traffic is small (< 0.7 Kbps).
Maximum of 10 views supported on wireless network.
Maximum of 1024 views supported on wired network.
Latency max 250 ms

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Flow Name 1 S5 Network
Network Connection on MC – S5 network
device
Usage Type Clinical
Function Waveforms, parameters, alarms
Purpose Transmit clinical data to other iCentral devices
Licensed/optional/required Licensed
Communication Partner iCentral
Device/IP Address/Network
Middle Layer Protocols DRI
Application Layer Protocol DRI
and Encoding
Traffic characterization and Variable
Bandwidth Requirements

Flow Name 2 InSite RSvP


Network Connection on IX Network
device
Usage Type Device servicing
Function GEHC remote service
Purpose Device health status notification
Licensed/optional/required Optional (user can disable service)
Communication Partner InSite RSvP Server/https://us1-ws.service.gehealth-
Device/IP Address/Network care.com/Internet, GE VPN
Middle Layer Protocols TCP
Application Layer Protocol HTTPS/128 bit SSL
and Encoding
Ports 443
Traffic characterization and Periodic (4kbytes/minute)
Bandwidth Requirements On-Demand (file transfers)

Flow Name 3 InSite RSvP Tunnel


Network Connection on IX Network
device
Usage Type Device servicing
Function GEHC remote service
Purpose Device health status notification
Licensed/optional/required Optional (user can disable service)
Communication InSite RSvP Server/https://us1-rd.service.gehealth-
PartnerDevice/IP care.com/Internet, GE VPN
Address/Network
Middle Layer Protocols TCP

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Flow Name 3 InSite RSvP Tunnel
Application Layer Protocol HTTPS/128 bit SSL
and Encoding
Ports 443
Traffic characterization and Periodic (4kbytes/minute)
Bandwidth Requirements On-Demand (file transfers)

Flow Name 4 HTTP/HTTPS proxies


Network Connection on IX Network
device
Usage Type/Function/Pur- Network Services/InSite RSvP
pose
Licensed/optional/required Optional (user can disable InSite RSvP) and only necessary if
hospital requires HTTP/HTTPS proxy for Internet access.
Communication Partner Proxy server/Hospital
Device/IP Address/Network
Middle Layer Protocols TCP
Application Layer Protocol HTTP/HTTPS
and Encoding
Ports Customer defined
Traffic characterization and Periodic (4kbytes/minute)
Bandwidth Requirements On-Demand (file transfers)

Flow Name 5 Webmin


Network Connection on IX Network
device
Usage Type/Function/Pur- Device servicing/Hospital biomed service
pose
Licensed/optional/required Required
Communication Partner PC/IX, Hospital Network
Device/IP Address/Network
Middle Layer Protocols TCP
Application Layer Protocol HTTPS/AES-256
and Encoding
Ports 10000
Traffic characterization and On-demand, user-initiated/varies by usage
Bandwidth Requirements

Flow Name 6 Ping – Hospital Network


Network Connection on IX Network
device
Usage Type/Function/Pur- Device servicing/Network troubleshooting (IX only)
pose
Licensed/optional/required Required

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Flow Name 6 Ping – Hospital Network
Communication Partner PC, Other Medical Devices/Hospital Network
Device/IP Address/Network
Middle Layer Protocols ICMP
Application Layer Protocol N/A
and Encoding
Ports N/A
Traffic characterization and On-demand, user-initiated/64bytes/sec for any requested
Bandwidth Requirements ping request, only one ping request can be run at a time,
multiple requests could be received from other devices.

Flow Name 7 Ping – IX Network


Network Connection on IX Network
device
Usage Type/Function/Pur- Device servicing/Network troubleshooting (IX only)
pose
Licensed/optional/required Required
Communication Partner PC, Other Medical Devices/IX Network
Device/IP Address/Network
Middle Layer Protocols ICMP
Application Layer Protocol N/A
and Encoding
Ports N/A
Traffic characterization and On-demand, user-initiated/64bytes/sec for any requested
Bandwidth Requirements ping request, only one ping request can be run at a time,
multiple requests could be received from other devices.

Flow Name 8 Ping – MC Network


Network Connection on MC Network
device
Usage Type/Function/Pur- Device servicing/Network troubleshooting (MC only)
pose
Licensed/optional/required Required
Communication Partner PC, Other Medical Devices/MC Network
Device/IP Address/Network
Middle Layer Protocols ICMP
Application Layer Protocol N/A
and Encoding
Ports N/A
Traffic characterization and On-demand, User-initiated/64bytes/sec for any requested
Bandwidth Requirements ping request, only one ping request can be run at a time,
multiple requests could be received from other devices.

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Flow Name 9 Software Transfer
Network Connection on IX Network
device
Usage Type/Function/Pur- Device servicing/perform software upgrades
pose
Licensed/optional/required Required
Communication Partner PC/IX Network
Device/IP Address/Network
Middle Layer Protocols TCP
Application Layer Protocol HTTP
and Encoding
Ports 10001
Traffic characterization and On-demand. Approximately 100 MB of software download
Bandwidth Requirements at low priority and very infrequently.

Flow Name 10 View 12SL from MUSE


Network Connection on IX Network
device
Usage Type Clinical
Function Retrieving
Purpose Displaying 12SL reports
Licensed/optional/required Licensed/Optional
Communication Partner Muse Server/Hospital
Device/IP Address/Network
Middle Layer Protocols TCP
Application Layer Protocol HTTP
and Encoding
Ports 80
Traffic characterization and On-demand, user initiated, from 500 KB to 1 MB.
Bandwidth Requirements

Flow Name 11 Printing


Network Connection on IX Network
device
Usage Type/Function/Pur- Clinical
pose
Licensed/optional/required Required
Communication Partner Networked printer/IX Network
Device/IP Address/Network
Middle Layer Protocols UDP/TCP
Application Layer Protocol IPP
and Encoding

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Flow Name 11 Printing
Ports 80,631
Traffic characterization and On-demand, user initiated
Bandwidth Requirements

Flow Name 12 DNS


Network Connection on IX Network
device
Usage Type/Function/Pur- Network services/Domain name resolution
pose
Licensed/optional/required Required
Communication Partner DNS server/Hospital network
Device/IP Address/Network
Middle Layer Protocols UDP
Application Layer Protocol DNS
and Encoding
Ports 53
Traffic characterization and Sporadic
Bandwidth Requirements

Flow Name 13 DHCP


Network Connection on IX Network
device
Usage Type/Function/Pur- Network services/Dynamic address assignment
pose
Licensed/optional/required Required
Communication Partner Networked printer/Hospital network
Device/IP Address/Network
Middle Layer Protocols UDP/TCP
Application Layer Protocol DHCP
and Encoding
Ports 67,68
Traffic characterization and Sporadic
Bandwidth Requirements

Flow Name 14 ADT


Network Connection on IX Network
device
Usage Type/Function/Pur- Clinical/Connection to ADT Server
pose
Licensed/optional/required Optional
Communication Partner ADT Server
Device/IP Address/Network
Middle Layer Protocols TCP

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Flow Name 14 ADT
Application Layer Protocol ADT
and Encoding
Ports 11111
Traffic characterization and On-demand, user initiated
Bandwidth Requirements

Required characteristics and configuration


of the network for support of the CARESCAPE
Monitor B650
The network must meet the specific requirements identified in the network information
flows described in this document for all traffic flows associated with the subset of
features, use cases and workflows required by the responsible organization’s users.

Potential risks to safety, effectiveness, or


security resulting from failure of IT network to
provide the required characteristics
Loss of network connectivity can result in the following hazardous situations:
● Missed alarm at a remote viewing station (bedside or display)
● Complete or partial loss or deterioration of remote monitoring of waveform and
parameter data at remote viewing device
Device mitigations:
● Low alarm volume is increased if network communication fails.
● Audio off, audio pause, and sleep states are interrupted if network communication
fails.
● User is notified of network communication failure. A message is displayed until the
user acknowledges it.
● User is notified if a duplicate IP address is detected.
● User is notified if a duplicate unit or bed name is detected.
WARNING BEFORE INSTALLATION. Compatibility is critical to safe and
effective use of this device. Please contact your local sales or
service representative prior to installation to verify system
compatibility.

WARNING INTERFACING OTHER EQUIPMENT. Connect only items that are


specified as part of the system and as compatible. For more
information, see the supplemental information provided.

In addition to the hazardous situations identified in this section, connection of the


CARESCAPE Monitor B650 to a network that includes other equipment could result
in other unidentified risks to patients, operators, or third parties. The responsible
organization should identify, analyze, evaluate and control these risks on an ongoing

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basis, including after changes to the network such as these listed, which could
introduce new risks and require additional analysis:
● Changing the network configuration.
● Connecting additional items to the network.
● Disconnecting items from the network.
● Updating equipments connected to the network.
● Upgrading equipments connected to the network.
If you have enabled the Visit Number Query to the ADT server, the medical record
number, the last name of the patient, or the last and first names of the patient are
sent over the IX network.

14 Addendum for CARESCAPE Monitor B650 service manual 2106778-009


content
GE Healthcare Finland Oy
Kuortaneenkatu 2
FI-00510 Helsinki
Finland
Tel: + 358 10 39411

www.gehealthcare.com

www.gehealthcare.com

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