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Invenia ABUS 2.0 Release Notes - UM - 4700-0044-00 - 4
Invenia ABUS 2.0 Release Notes - UM - 4700-0044-00 - 4
4700-0044-00
Rev. 4
Operating Documentation
Copyright 2018-2019 By General Electric Co.
Regulatory Requirement
DATE
REV (YYYY/MM/DD) REASON FOR CHANGE
REVISION REVISION
PAGE NUMBER NUMBER PAGE NUMBER NUMBER
Please verify that you are using the latest revision of this document. If you need to know
the latest revision, contact your distributor, local GE Sales Representative, or in the USA
call the GE Ultrasound Clinical Answer Center at 1 800 682 5327 or 1 262 524 5698.
Conformance Standards
The following classifications are in accordance with the IEC/
EN 60601-1:6.8.1:
• According to IEC/EN 60601-1,
• Equipment is Class I, Type BF.
• According to CISPR 11,
• Equipment is Group 1, Class A ISM Equipment.
This product complies with the regulatory requirement of the
following:
• Council Directive 93/42/EEC concerning medical devices:
the CE label affixed to the product testifies compliance to
the Directive.
The location of the CE marking is shown in the Addendum
of the Release Notes.
Authorized EU Representative
GE Medical Systems SCS
283 rue de la Minière 78530 BUC, France
Original Documentation
• The original document was written in English.
Restricted Rights
This document contains proprietary and confidential information
that is the property of GE, Inc. It is protected by copyright and
distributed under licenses restricting its use, copying, and
distribution. No part of this document may be reproduced in any
form without prior written authorization from GE.
This manual is provided “as is” without warranty of any kind,
either expressed or implied, including, without limitation,
merchantability, fitness for a particular purpose or
non-infringement. It may include technical inaccuracies or
typographical errors. Changes are periodically made to the
information it contains. GE may make improvements and/or
changes in the programs and/or interfaces described in this
publication at any time.
Patents
US 7597663, US 7615008, US 7556602, and CN 100471457C
Addendum
OVERVIEW
The content in these Release Notes includes an Addendum to
the Basic User Manual, Direction 4700-0041-XX. Important
system Notes and Workarounds are also provided. Information
included in these Release Notes supersedes Basic User
Manual.
Please finish the current scan! The current scan is processing, the user must finish
the current scan.
There are two shipping crate sizes, one is 65"H x 68"L x 33"W
(1.65m H x 1.72m L x 0.85m W) and the other is 71"H x 46"L x
36"W (1.81m H x 1.17m L x 0.91m W). For more information on
packaging, refer to the Invenia ABUS 2.0 Basic Service Manual,
Part Number 4700-0043-00.
17. Identification and Serial Identification and Serial Number Label– Identification
Number Label USA/Asia 120V console and Serial
Number
Manufacturer’s name and address Label
Catalog Number
Serial Number
Date of manufacture
EMC Performance
150 kHz - 80 MHz 80 MHz - 800 MHz 800 MHz - 2.5 GHz
d=[3.5/3] square root of d = [3.5/3] square root d = [7/3] square root of
P of P P
For transmitters rated at a maximum output power not listed above, the separation distance can be
estimated using the equation in the corresponding column, where P is the maximum output power rating of
the transmitter in watts (W) according to the transmitter manufacturer.
NOTE: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects, and people.
General Notice
Cable Specification
Supplementary information:
*Note: AC = AC Power Port
TP = Telecommunication Port
SIP = Signal Input Port
Declaration of Emissions
The system is intended for use in the electromagnetic environment specified below. The
user of the system should assure that it is used in such an environment.
RF Emissions Group 1 This system uses RF energy only for its internal function.
CISPR 11 Therefore, its RF emissions are very low and are not likely to
cause any interference in nearby electronic equipment.
RF Emissions Class A This system is suitable for use in all establi/shments, other than
CISPR 11 domestic establishments and those directly connected to the
public low-voltage power supply network that supplies buildings
Harmonic Class A used for domestic purposes, provided the following warning is
Emissions heeded:
IEC 61000-3-2 WARNING: The EMISSIONS characteristics of this equipment
make it suitable for use in industrial areas and hospitals (CISPR
Voltage Complies
11 class A). If it is used in a residential environment (for which
Fluctuations/Flicker CISPR 11 class B is normally required) this equipment might not
Emissions
offer adequate protection to radio-frequency communication
IEC 61000-3-3
services. The user might need to take mitigation measures, such
as relocating or reorienting the equipment.
Declaration of Immunity
This system is intended for use in the electromagnetic environment specified below. The
customer or the user of this system should assure that it is used in such an environment.
Environments of
INTENDED USE Professional healthcare facility environment
This system is intended for use in the electromagnetic environment specified below. The
customer or the user of this system should assure that it is used in such an environment.
Environments of
INTENDED USE Professional healthcare facility environment
IEC 61000-4-4 ±2 kV for power Edition 4 series Mains power quality should
Electrical fast supply lines 100 kHz ± 2 kV for power supply be that of a typical
transient/burst rate lines 100 kHz rate commercial and/or hospital
± 1 kV for input/output environment.
± 1 kV for input/output lines 100 kHz rate
lines 100 kHz rate
IEC 61000-4-11 0 % UT; 0.5cycle, Edition 4 series Mains power quality should
Voltage dips and Phase: 0 % UT; 0.5cycle, Phase: be that of a typical
short interruptions 0,45,90,135,180,225, 0,45,90,135,180,225,270, commercial and/or hospital
and voltage variations 270,315° 315° environment. If the user
on power supply input 0 % UT; 1cycle, 0 % UT; 1cycle, Phase: 0° requires continued operation
lines Phase: 0° 70 % UT; 25/30cycle, during power mains
70 % UT; 25/30cycle, Phase: 0° interruptions, it is
Phase: 0° 0 % UT; 250/300 cycle recommended that the
0 % UT; 250/300 Note: Apply IEC system be powered from a
cycle 60601-2-37 (202.6.2.7) UPS or a battery option.
Note: Apply IEC
60601-2-37
(202.6.2.7)
This system is intended for use in the electromagnetic environment specified below. The
customer or the user of this system should assure that it is used in such an environment.
Environments of
INTENDED USE Professional healthcare facility environment
This system is intended for use in the electromagnetic environment specified below. The
customer or the user of this system should assure that it is used in such an environment.
Environments of
INTENDED USE Professional healthcare facility environment
a. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and
land mobile radios, amateur radio, AM and FM radio broadcast, and TV broadcast cannot be predicted
theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an
electromagnetic site survey should be considered. If the measured field strength in the location in which this
system is used exceeds the applicable RF compliance level above, this system should be observed to verify
normal operation. If abnormal performance is observed, additional measures may be necessary, such as
reorienting or relocating this system.
b. Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V/m.
c. As an alternative to FM modulation, 50 % pulse modulation at 18 Hz may be used because while it does not
represent actual modulation, it would be worst case.
NOTE: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption
and reflection from structures, objects, and people.
780
5785
KNOWN ISSUE
Category Note/Workaround
Image Artifact When reviewing the coronal image for scan coverage and nipple marker placement, an
Potential image artifact may be visible in the very nearfield, around 2.0mm from the skin surface.
If the artifact is visible and bothersome, the system software provides the option to change
the starting depth of the default nearfield coronal review, depending on the customer's
preference for QC and nipple marker placement. There is always the option to scroll to any
depth. See Invenia ABUS 2.0 Basic User Manual.
The potential artifact, while visible in the transverse view, may be very hard to pinpoint and
does not obscure underlying tissue or affect the deeper tissue.