CARESCAPE Monitor B650 Addendum to Technical Manual Networking disclosure Sept 2013

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.

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Addendum for CARESCAPE Monitor B650 technical manual

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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

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Addendum for CARESCAPE Monitor B650 technical manual

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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 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.

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Remote viewing of 12SL ECG reports at compatible network devices.

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Remote configuration (patient admission, alarm settings, etc.) from compatible network devices.

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Remote service diagnostics and configuration (Webmin/InSite).

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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 type

IEEE 802.3-1998 10/100BaseT Ethernet

Speeds and duplex modes supported

10 Mbps half and full duplex, 100 Mbps half and full duplex, Autonegotiate (default)

Default IP Address (from factory)

MC: 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

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QoS Support

IP layer DSCP tagging

Connection Name 2

Information exchange (IX) network port

Physical network connection type

IEEE 802.3-1998 10/100BaseT Ethernet

Speeds and duplex modes supported

10 Mbps half and full duplex, 100 Mbps half and full duplex, Autonegotiate (default)

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Connection Name 2

Information exchange (IX) network port

Default IP Address (from factory)

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

IP Addressing

IPv4 Static (default) or DHCP

QoS Support

No Markings

Connection Name

WLAN

General WLAN Standards/Certifications

IEEE 802.11a/b/g FCC Part 15.247 for USA FCC Part 15.407 for USA FCC Part 15.107 for North America FCC Part 15.109 for North America RSS-210 for Canada ICES 003 Class B for Canada EN 300.328 V1.7.1 for Europe EN 301.893 V1.4.1 for Europe EN 301 489-1 V1.6.1 for Europe EN 301 489-17 V1.2.1 for Europe ARIB-STD T71 V5 for Japan ARIB-STD 33 V5.3 for Japan ARIB-STD 66 V3.3 for Japan AS/NZS 4268:2008 for Australia European Directives 1999/5/EC & 2002/95/EEC IEC 60601-1-2: 2001 +A1: 2004, EN 60601-1-2: 2001 +A1: 2006 Australia AS/NZS CISPRA 22 EU: EN55022:2006 Class B EN55024: 1998 +A1: 2001 +A2: 2003 47CFR15: 1998 (FCC Part 15 Class B) EN 60950-1:2006 IEC 60950-1:2001 UL 60950-1, CSA C22.2 No.60950-1

Antenna Gain

2.4 GHz: -0.1dBi Avg., +0.6dBi Maximum 5 GHz: +0.2dBi Avg., +2.0dBi Maximum

Supported Channel Range

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2.4 GHz: 1-14 5 GHz: 34-165

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Connection Name

WLAN

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 (802.11b) PHYs 2.4 GHz ERP OFDM (802.11g) PHY

1 Mbps/-86, 2 Mbps/-83, 5.5 Mbps/-82, 11 Mbps/-79 (Sensitivity corresponds to 8% max packet error rate with 1024 byte MPDU.) 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.)

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 Selection

802.11h DFS

MAC-layer QoS and Power Save Support

802.11e HCF-EDCA / EDCF / WMM: Four standard access 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

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Flow Name 1

Unity Services

Network Connection on device

MC network

Usage Type

Clinical

Function

Waveforms, parameters, alarms

Purpose

Transmit clinical data to other devices on the network

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Flow Name 1

Unity Services

Licensed/optional/required

Licensed

Communication Partner Device/IP Address/Network

Unity Devices/MC Network

Middle Layer Protocols

UDP

Application Layer Protocol and Encoding

Unity

Ports

Standard Unity ports

Traffic characterization and Bandwidth Requirements

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.

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Latency max

250 ms

Flow Name 1

S5 Network

Network Connection on device

MC – S5 network

Usage Type

Clinical

Function

Waveforms, parameters, alarms

Purpose

Transmit clinical data to other iCentral devices

Licensed/optional/required

Licensed

Communication Partner Device/IP Address/Network

iCentral

Middle Layer Protocols

DRI

Application Layer Protocol and Encoding

DRI

Traffic characterization and Bandwidth Requirements

Variable

Flow Name 2

InSite ExC

Network Connection on device

IX Network

Usage Type

Device servicing

Function

GEHC remote service

Purpose

Device health status notification

Licensed/optional/required

Optional (user can disable service)

Communication Partner Device/IP Address/Network

InSite ExC Server/https://us1-ws.service.gehealthcare.com/Internet, GE VPN

Middle Layer Protocols

TCP

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Flow Name 2

InSite ExC

Application Layer Protocol and Encoding

HTTPS/128 bit SSL

Ports

443

Traffic characterization and Bandwidth Requirements

Periodic (4kbytes/minute)

Flow Name 3

InSite ExC Tunnel

Network Connection on device

IX Network

Usage Type

Device servicing

Function

GEHC remote service

Purpose

Device health status notification

Licensed/optional/required

Optional (user can disable service)

Communication PartnerDevice/IP Address/Network

InSite ExC Server/https://us1-rd.service.gehealthcare.com/Internet, GE VPN

Middle Layer Protocols

TCP

Application Layer Protocol and Encoding

HTTPS/128 bit SSL

Ports

443

Traffic characterization and Bandwidth Requirements

Periodic (4kbytes/minute)

Flow Name 4

HTTP/HTTPS proxies

Network Connection on device

IX Network

Usage Type/Function/Purpose

Network Services/InSite ExC

Licensed/optional/required

Optional (user can disable InSite ExC) and only necessary if hospital requires HTTP/HTTPS proxy for Internet access.

Communication Partner Device/IP Address/Network

Proxy server/Hospital

Middle Layer Protocols

TCP

Application Layer Protocol and Encoding

HTTP/HTTPS

Ports

Customer defined

Traffic characterization and Bandwidth Requirements

Periodic (4kbytes/minute)

On-Demand (file transfers)

On-Demand (file transfers)

On-Demand (file transfers)

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Flow Name 5

Webmin

Network Connection on device

IX Network

Usage Type/Function/Purpose

Device servicing/Hospital biomed service

Licensed/optional/required

Required

Communication Partner Device/IP Address/Network

PC/IX, Hospital Network

Middle Layer Protocols

TCP

Application Layer Protocol and Encoding

HTTPS/AES-256

Ports

10000

Traffic characterization and Bandwidth Requirements

On-demand, user-initiated/varies by usage

Flow Name 6

Ping – Hospital Network

Network Connection on device

IX Network

Usage Type/Function/Purpose

Device servicing/Network troubleshooting (IX only)

Licensed/optional/required

Required

Communication Partner Device/IP Address/Network

PC, Other Medical Devices/Hospital Network

Middle Layer Protocols

ICMP

Application Layer Protocol and Encoding

N/A

Ports

N/A

Traffic characterization and Bandwidth Requirements

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

IX Network

Usage Type/Function/Purpose

Device servicing/Network troubleshooting (IX only)

Licensed/optional/required

Required

Communication Partner Device/IP Address/Network

PC, Other Medical Devices/IX Network

Middle Layer Protocols

ICMP

Application Layer Protocol and Encoding

N/A

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Flow Name 7

Ping – IX Network

Ports

N/A

Traffic characterization and Bandwidth Requirements

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 device

MC Network

Usage Type/Function/Purpose

Device servicing/Network troubleshooting (MC only)

Licensed/optional/required

Required

Communication Partner Device/IP Address/Network

PC, Other Medical Devices/MC Network

Middle Layer Protocols

ICMP

Application Layer Protocol and Encoding

N/A

Ports

N/A

Traffic characterization and Bandwidth Requirements

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 device

IX Network

Usage Type/Function/Purpose

Device servicing/perform software upgrades

Licensed/optional/required

Required

Communication Partner Device/IP Address/Network

PC/IX Network

Middle Layer Protocols

TCP

Application Layer Protocol and Encoding

HTTP

Ports

10001

Traffic characterization and Bandwidth Requirements

On-demand. Approximately 100 MB of software download at low priority and very infrequently.

Flow Name 10

View 12SL from MUSE

Network Connection on device

IX Network

Usage Type

Clinical

Function

Retrieving

Purpose

Displaying 12SL reports

Licensed/optional/required

Licensed/Optional

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Flow Name 10

View 12SL from MUSE

Communication Partner Device/IP Address/Network

Muse Server/Hospital

Middle Layer Protocols

TCP

Application Layer Protocol and Encoding

HTTP

Ports

80

Traffic characterization and Bandwidth Requirements

On-demand, user initiated, from 500 KB to 1 MB.

Flow Name 11

Printing

Network Connection on device

IX Network

Usage Type/Function/Purpose

Clinical

Licensed/optional/required

Required

Communication Partner Device/IP Address/Network

Networked printer/IX Network

Middle Layer Protocols

UDP/TCP

Application Layer Protocol and Encoding

IPP

Ports

80,631

Traffic characterization and Bandwidth Requirements

On-demand, user initiated

Flow Name 12

DNS

Network Connection on device

IX Network

Usage Type/Function/Purpose

Network services/Domain name resolution

Licensed/optional/required

Required

Communication Partner Device/IP Address/Network

DNS server/Hospital network

Middle Layer Protocols

UDP

Application Layer Protocol and Encoding

DNS

Ports

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Traffic characterization and Bandwidth Requirements

Sporadic

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Flow Name 13

DHCP

Network Connection on device

IX Network

Usage Type/Function/Purpose

Network services/Dynamic address assignment

Licensed/optional/required

Required

Communication Partner Device/IP Address/Network

Networked printer/Hospital network

Middle Layer Protocols

UDP/TCP

Application Layer Protocol and Encoding

DHCP

Ports

67,68

Traffic characterization and Bandwidth Requirements

Sporadic

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)

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Complete or partial loss or deterioration of remote monitoring of waveform and parameter data at remote viewing device

Device mitigations:

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Low alarm volume is increased if network communication fails.

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Audio off, audio pause, and sleep states are interrupted if network communication fails.

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User is notified of network communication failure. A message is displayed until the user acknowledges it.

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User is notified if a duplicate IP address is detected.

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User is notified if a duplicate unit or bed name is detected.

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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 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 basis, including after changes to the network such as these listed, which could introduce new risks and require additional analysis:

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Changing the network configuration.

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Connecting additional items to the network.

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Disconnecting items from the network.

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Updating equipments connected to the network.

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Upgrading equipments connected to the network.

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content

Headquarters

Asia Headquarters

GE Healthcare Finland Oy

GE Medical Systems

GE Medical Systems

Kuortaneenkatu 2

Information Technologies, Inc.

Information Technologies Asia; GE (China) Co., Ltd.

FI-00510 Helsinki

8200 West Tower Avenue

No1 Huatuo Road,

Finland

Milwaukee, WI 53223 USA

Zhangjiang Hi-tech Park Pudong

Tel: + 358 10 39411

Tel: + 1 414 355 5000

Shanghai P.R.China 201203

Fax: + 358 9 1463310

1 800 558 5120 (US only)

Tel: + 86 21 5257 4650

www.gehealthcare.com

Fax: + 1 414 355 3790

Fax: + 86 21 5208 2008

www.gehealthcare.com