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Edwards HemoSphere

Edwards HemoSphere
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226
HemoSphere Advanced Monitor G Guidance and Manufacturers Declaration
G.3.1 Quality of Service for Wireless Technology
The HemoSphere advanced monitor wireless technology enables transmission of physiologic data, alarms,
and device notifications to supported Hospital Information Systems (HIS) for electronic charting and
archival purposes only. Wirelessly transmitted data is not intended for remote alarm management or real-
time, remote data visualization systems. Quality of service (QoS) is specified in terms of total data loss for a
normal connection where the HemoSphere advanced monitor is operating at medium wireless signal
strength or higher (table 8-1), with good HIS connection (table 8-2). HemoSphere advanced monitor
wireless data transmission has been validated to have less than 5% total data loss under these conditions.
HemoSphere advanced monitor wireless technology has an effective range of 150 feet, line of sight and 75
feet, non-line of sight. The effective range might be affected due to the presence of other wireless emitters.
The HemoSphere advanced monitor supports data transmission using Health Level 7 (HL7) messaging
standard. All data transmitted is expected to be acknowledged by the receiving system. Data is resent if not
sent successfully. The HemoSphere advanced monitor automatically tries to re-establish any HIS
connections that are interrupted. If pre-existing HIS connection(s) cannot be reestablished, the
HemoSphere advanced monitor alerts the user with an audible alert and message (Alert: HIS Connectivity
Loss, see table 13-4).
Compliance ETSI Regulatory Domain
EN 300 328 EN 55022:2006 Class B
EN 300 328 v1.8.1 (BT 2.1) EN 55024:1998 +A1:2001, A2:2003
EN 301 489-1 EN 61000-3-2:2006
EN 301 489-17 EN 61000-3-3:1995 +A1:2001, A2:2005
EN 301 893 EU 2002/95/EC (RoHS)
EN 60950-1
FCC Regulatory Domain (Certification ID: SQG-WB45NBT)
FCC 15.247 DTS – 802.11b/g (Wi-Fi): 2.4 GHz & 5.8 GHz
FCC 15.407 UNII – 802.11a (Wi-Fi): 2.4 GHz & 5.4 GHz
FCC Part 15 Class B UL 60950
Industry Canada (Certification ID: 3147A-WB45NBT)
RSS-210 – 802.11a/b/g/n (Wi-Fi) – 2.4 GHz, 5.8 GHz, 5.2 GHz, and 5.4 GHz
ICES-003, Class B
MIC (Japan) (Certification ID: )
STD-T71 Article 2 Item 19, Category WW (2.4GHz Channels 1-13)
Article 2 Item 19-2, Category GZ (2.4GHz Channel 14)
Article 2 Item 19-3 Category XW (5150-5250 W52 & 5250-5350 W53)
KC (Korea) (Certification ID: MSIP-CRM-LAI-WB45NBT)
Certifications Wi-Fi Alliance
802.11a, 802.11b, 802.11g , 802.11n
WPA Enterprise
WPA2 Enterprise
Cisco Compatible Extensions (Version 4)
FIPS 140-2 Level 1
Linux 3.8 running on 45 Series Wi-Fi Module with ARM926 (ARMv5TEJ) -
OpenSSL FIPS Object Module v2.0 (validation certificate #1747)
Antenna Type PCB Dipole
Antenna Dimensions 36 mm x 12 mm x 0.1 mm
Table G-6 HemoSphere advanced monitor wireless information (continued)
Feature Description
Status = Released Printed Date: 2018-01-16 Released Date: 2017-09-14

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