GE Healthcare

Addendum for CARESCAPE Monitor B450

technical manual
Networking disclosure to facilitate network risk
management

Addendum for CARESCAPE Monitor B450

technical manual
English
2062978-001 DVD, 2062978-002 DVD
(510k)
2062973-013 paper
© 2013 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 B450 technical manual 2062973-013

11 September 2013
 Contents
Purpose and scope ......................................................................................... 5
Purpose of the CARESCAPE Monitor B450 connection to a network ........... 5
CARESCAPE Monitor B450 network interface technical
specifications .................................................................................................. 5
Network information flows............................................................................. 7
Required characteristics and configuration of the network for support
of the CARESCAPE Monitor B450.................................................................. 13
Potential risks to safety, effectiveness, or security resulting from
failure of IT network to provide the required characteristics ..................... 13

2062973-013 Addendum for CARESCAPE Monitor B450 technical manual 3

4 Addendum for CARESCAPE Monitor B450 technical manual 2062973-013
Purpose and scope
This disclosure is intended to satisfy the requirements of IEC 60601-1:2005 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 B450.

Purpose of the CARESCAPE Monitor B450

connection to a network
The CARESCAPE Monitor B450 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.
● Acting as a Citrix client for network access to applications on remote Citrix servers.

CARESCAPE Monitor B450 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 and full duplex, 100 Mbps half and full duplex,
supported Autonegotiate (default)
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 and full duplex, 100 Mbps half and full duplex,
supported Autonegotiate (default)

2062973-013 Addendum for CARESCAPE Monitor B450 technical manual 5

 Connection Name 2
Default IP Address (from
factory)
IP Addressing
QoS Support
Connection Name
General WLAN
Standards/Certifications
Antenna Gain
Supported Channel Range
Transmit Power Range
Supported Data Rates (Mbps)
and Corresponding Receive
Sensitivity (dBm), referenced
to antenna conducted
output:
2.4 GHz DSSS EIS (802.11b)
PHYs
6 Addendum for CARESCAPE Monitor B450 technical manual
Information exchange (IX) network port
IP address — 172.18.x.y
NOTE: x and y are equal to the last two octets of the MAC
address.
Subnet mask — 255.255.0.0
Gateway — 172.18.254.254
IPv4 Static (default) or DHCP
No Markings
WLAN
802.11a/b/g
● USA: FCC Part 15.247, 15.205, 15.207, 15.209, 15.407
FCC ID: PVH0926
● Canada: RSS-210, RSS-Gen
IC ID: 5325A-0926
● European R&TTE Directive 1999/5/EC: EN 300 328 V1.7.1,
EN 301 893 V1.6.1
EN 301 489-1 V1.8.1, EN 301 489-17 V2.1.1
EN 61000-6-2 (2005)
● Safety Compliance: IEC 60950-1:2005 (2nd Edition)/EN
60950-1:2006
Medical Electrical Equipment
● IEC 60601-1-2 (2007) (for single antenna configurations)
2.4 GHz: +2.4dBi Avg., +2.6dBi Maximum
5 GHz: +0.3dBi Avg., +3.5dBi Maximum
2.4 GHz: 1-14
5 GHz: 36-165
2.4 GHz TRP: up to +12dBm
2.4 GHz EIRP: up to +19dBm
5 GHz TRP: up to +8dBm
5 GHz EIRP: up to +16dBm
May be further restricted on some channels according to
regulatory domain.
11 Mbps: Channel 1/-67 dBm, Channel 6/-88 dBm, Channel
11/-90 dBm
(Sensitivity corresponds to 8% max packet error rate with
1024 byte MPDU.)
2062973-013
 Connection Name
2.4 GHz OFDM EIS (802.11g)
PHY
5 GHz OFDM EIS (802.11a)
PHY
Minimum Expected RSSI in
Coverage Area
Dynamic Frequency
Selection
Transmit Power Control
MAC-layer QoS and Power
Save Support
Data Encryption Support
Authentication Support
Over-the-air Configuration
Support
IP Addressing
IP Layer QoS
Network information flows
Flow Name 1
Network Connection on
device
Usage Type
Function
Purpose
Licensed/optional/required
Communication Partner
Device/IP Address/Network
Middle Layer Protocols
Application Layer Protocol
and Encoding
2062973-013 Addendum for CARESCAPE Monitor B450 technical manual
WLAN
54 Mbps: Channel 1/-71 dBm, Channel 6/-76 dBm, Channel
11/-76 dBm
(Sensitivity corresponds to 10% max packet error rate with
1024 byte MPDU.)
24 Mbps: Channel 36/-79 dBm, Channel 48/-79 dBm,
Channel 60/-79 dBm, Channel 100/-83 dBm, Channel
140/-77 dBm, Channel 165/-77 dBm
(Sensitivity corresponds to 10% max packet error rate with
1024 byte MPDU.)
-60dBm +/-5dB @ 54Mbps
802.11h DFS
802.11h TPC
Dynamic Transmit Power Adaptation
802.11e HCF-EDCA / EDCF / WMM: Four standard access
categories plus legacy DCF and customizable CWmin,
CWmax, AIFS and TXOP settings
802.11e WMM: Customizable Cwmin, Cwmax, AIFS, TXOP,
DSCP settings
Open
WEP (128-bit)
WPA-PSK (TKIP)
WPA2-PSK (AES-CCMP)
None
IPv4 statically configured
DSCP tagging per dataflow, 802.11e, WMM
Unity Services
MC network
Clinical
Waveforms, parameters, alarms
Transmit clinical data to other devices on the network
Licensed
Unity Devices/MC Network
UDP
Unity
7
 Flow Name 1
Ports
Traffic characterization and
Bandwidth Requirements
Latency max
Flow Name 1
Network Connection on
device
Usage Type
Function
Purpose
Licensed/optional/required
Communication Partner
Device/IP Address/Network
Middle Layer Protocols
Application Layer Protocol
and Encoding
Traffic characterization and
Bandwidth Requirements
Flow Name 2
Network Connection on
device
Usage Type
Function
Purpose
Licensed/optional/required
Communication Partner
Device/IP Address/Network
Middle Layer Protocols
Application Layer Protocol
and Encoding
Ports
Traffic characterization and
Bandwidth Requirements
8 Addendum for CARESCAPE Monitor B450 technical manual
Unity Services
Standard Unity ports
Periodic traffic.
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.
250 ms
S5 Network
MC – S5 network
Clinical
Waveforms, parameters, alarms
Transmit clinical data to other iCentral devices
Licensed
iCentral
DRI
DRI
Variable
InSite ExC
IX Network
Device servicing
GEHC remote service
Device health status notification
Optional (user can disable service)
InSite ExC Server/https://us1-ws.service.gehealth-
care.com/Internet, GE VPN
TCP
HTTPS/128 bit SSL
443
Periodic (4kbytes/minute)
On-Demand (file transfers)
2062973-013
 Flow Name 3
Network Connection on
device
Usage Type
Function
Purpose
Licensed/optional/required
Communication
PartnerDevice/IP
Address/Network
Middle Layer Protocols
Application Layer Protocol
and Encoding
Ports
Traffic characterization and
Bandwidth Requirements
Flow Name 4
Network Connection on
device
Usage Type/Function/Pur-
pose
Licensed/optional/required
Communication Partner
Device/IP Address/Network
Middle Layer Protocols
Application Layer Protocol
and Encoding
Ports
Traffic characterization and
Bandwidth Requirements
Flow Name 5
Network Connection on
device
Usage Type/Function/Pur-
pose
Licensed/optional/required
Communication Partner
Device/IP Address/Network
Middle Layer Protocols
2062973-013 Addendum for CARESCAPE Monitor B450 technical manual
InSite ExC Tunnel
IX Network
Device servicing
GEHC remote service
Device health status notification
Optional (user can disable service)
InSite ExC Server/https://us1-rd.service.gehealth-
care.com/Internet, GE VPN
TCP
HTTPS/128 bit SSL
443
Periodic (4kbytes/minute)
On-Demand (file transfers)
HTTP/HTTPS proxies
IX Network
Network Services/InSite ExC
Optional (user can disable InSite ExC) and only necessary if
hospital requires HTTP/HTTPS proxy for Internet access.
Proxy server/Hospital
TCP
HTTP/HTTPS
Customer defined
Periodic (4kbytes/minute)
On-Demand (file transfers)
Webmin
IX Network
Device servicing/Hospital biomed service
Required
PC/IX, Hospital Network
TCP
9
 Flow Name 5 Webmin
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
device
Usage Type/Function/Pur-
pose
Licensed/optional/required
Communication Partner
Device/IP Address/Network
Middle Layer Protocols
Application Layer Protocol
and Encoding
Ports
Traffic characterization and
Bandwidth Requirements
IX Network
Device servicing/Network troubleshooting (IX only)
Required
PC, Other Medical Devices/Hospital Network
ICMP
N/A
N/A
On-demand, user-initiated, 64bytes/sec for any requested
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
device
Usage Type/Function/Pur-
pose
Licensed/optional/required
Communication Partner
Device/IP Address/Network
Middle Layer Protocols
Application Layer Protocol
and Encoding
Ports
Traffic characterization and
Bandwidth Requirements
IX Network
Device servicing/Network troubleshooting (IX only)
Required
PC, Other Medical Devices/IX Network
ICMP
N/A
N/A
On-demand, user-initiated, 64bytes/sec for any requested
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

10 Addendum for CARESCAPE Monitor B450 technical manual 2062973-013

 Flow Name 8
Licensed/optional/required
Communication Partner
Device/IP Address/Network
Middle Layer Protocols
Application Layer Protocol
and Encoding
Ports
Traffic characterization and
Bandwidth Requirements
Ping – MC Network
Required
PC, Other Medical Devices/MC Network
ICMP
N/A
N/A
On-demand, User-initiated, 64bytes/sec for any requested
ping request, only one ping request can be run at a time,
multiple requests could be received from other devices.

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

2062973-013 Addendum for CARESCAPE Monitor B450 technical manual 11

 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
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

12 Addendum for CARESCAPE Monitor B450 technical manual 2062973-013

 Flow Name 14
Network Connection on
device
Usage Type/Function/Pur-
pose
Licensed/optional/required
Communication Partner
Device/IP Address/Network
Middle Layer Protocols
Application Layer Protocol
and Encoding
Ports
Traffic characterization and
Bandwidth Requirements
Citrix ICA
IX Network
Clinical/Connection to Citrix Server
Licensed/Optional
Citrix server/Hospital network
TCP
Citrix ICA
Customer defined (default 1494)
On-demand, user initiated

Required characteristics and configuration

of the network for support of the CARESCAPE
Monitor B450
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.

2062973-013 Addendum for CARESCAPE Monitor B450 technical manual 13

 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 equipment
compatibility.

WARNING — INTERFACING OTHER EQUIPMENT — Connect only items

that are specified as part of the system and as compatible.
For more information, see the CARESCAPE Modular Monitors
Supplemental Information Manual.

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

CARESCAPE Monitor B450 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
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.

14 Addendum for CARESCAPE Monitor B450 technical manual 2062973-013

content
 Headquarters
GE Healthcare Finland Oy GE Medical Systems
Kuortaneenkatu 2 Information Technologies, Inc.
FI-00510 Helsinki 8200 West Tower Avenue
Finland Milwaukee, WI 53223 USA
Tel: + 358 10 39411 Tel: + 1 414 355 5000
Fax: + 358 9 1463310 1 800 558 5120 (US only)
www.gehealthcare.com Fax: + 1 414 355 3790
Asia Headquarters
GE Medical Systems
Information Technologies Asia; GE (China) Co., Ltd.
No1 Huatuo Road,
Zhangjiang Hi-tech Park Pudong
Shanghai P.R.China 201203
Tel: + 86 21 5257 4650
Fax: + 86 21 5208 2008

www.gehealthcare.com