Download as pdf or txt
Download as pdf or txt
You are on page 1of 24

Technical Publications

4700-0044-00
Rev. 4

InveniaTM ABUS 2.0


Release Notes

Operating Documentation
Copyright 2018-2019 By General Electric Co.
Regulatory Requirement

This product complies with regulatory requirements of the following European


Directive 93/42/EEC concerning medical devices.

First CE Marked in 2019.


This manual is a reference for the Invenia ABUS 2.0. It applies to Version 2.0
software or later.
Revision History
Reason for Change

DATE
REV (YYYY/MM/DD) REASON FOR CHANGE

Rev. 1 2018/07/08 Preliminary Release

Rev. 2 2018/07/27 Updated manufacturing address, added notes and workaround.

Rev. 3 2019/01/15 Updated device label information.

Rev. 4 2019/04/02 Added CE Mark and Authorized EU Rep.

List of Effective Pages

REVISION REVISION
PAGE NUMBER NUMBER PAGE NUMBER NUMBER

Title Page Rev. 4 Table of Contents Rev. 4

Revision History Rev. 4 Chapter 1 Rev. 4

Regulatory Requirements Rev. 4

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.

Invenia ABUS 2.0 – Release Notes i-1


4700-0044-00 Rev. 4
Regulatory Requirements

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

i-2 Invenia ABUS 2.0 – Release Notes


4700-0044-00 Rev. 4
Conformance Standards (continued)
This product complies with the regulatory requirement of the
following:
• International Electrotechnical Commission (IEC)
• IEC/EN 60601-1 Medical Electrical Eqiupment, Part 1
General Requirements for Safety.
• IEC/EN 60601-1-2 Electromagnetic disturbances -
Requirements and tests.
• IEC/EN 60601-1-4 Programmable electrical medical
systems.
• IEC 60601-1-6 (Usability)
• IEC 60601-2-37 Medical electrical equipment. Particular
requirements for the safety of ultrasonic medical
diagnostic and monitoring equipment.
International Organization of Standards (ISO)
• ISO 10993-1 Biological evaluation of medical devices.
Underwriters’ Laboratories, Inc. (UL)
• UL 60601-1 Medical Electrical Equipment, Part 1
General Requirements for Safety.
• Canadian Standards Association (CSA).
CSA 22.2, 601.1 Medical Electrical Equipment, Part 1
General Requirements for Safety.
• Medical Device Good Manufacturing Practice Manual
Issued by the FDA (Food and Drug Administration,
Department of Health, USA).
• EN/ISO 15223-1 Medical devices Symbols to be used
with medical device labels, labeling and information to
be supplied — Part 1: General requirements.

Original Documentation
• The original document was written in English.

Invenia ABUS 2.0 – Release Notes i-3


4700-0044-00 Rev. 4
Importer Information

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

Manufacturer Name and Address

GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC


9900 Innovation Drive
Wauwatosa, WI 53226

i-4 Invenia ABUS 2.0 – Release Notes


4700-0044-00 Rev. 4
Chapter 1
InveniaTM ABUS 2.0
Release Notes

This document supplements the Invenia ABUS 2.0


Basic User Manual and System Setup and Basic
Service Manual.

Keep these Release Notes with the Invenia ABUS 2.0


manuals and have all users become familiar with its
contents.

Invenia ABUS 2.0 – Release Notes 1-1


4700-0044-00 Rev. 4
InveniaTM ABUS 2.0 Release Notes

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.

1-2 Invenia ABUS 2.0 – Release Notes


4700-0044-00 Rev. 4
Addendum

UPDATES TO INVENIA ABUS 2.0 THE BASIC USER MANUAL

Update to the Contact information for Korea

Table 1-1: Korea

KOREA TEL: +82 2 6201 3114

Update to System Messages in the Troubleshooting Chapter

The following message may appear during the scan. Please


refer to the cause/action information provided when trying to
resolve the issue.

Table 1-2: Device Messages

System Message Cause/Action to Take

Please finish the current scan! The current scan is processing, the user must finish
the current scan.

Update to the Packaging information

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.

Invenia ABUS 2.0 – Release Notes 1-3


4700-0044-00 Rev. 4
InveniaTM ABUS 2.0 Release Notes

Update to Device Labels in the Safety Information Chapter

Warning Label Locations

Figure 1-1. Rear Panel Label Location

Label Icon Description


The following table describes the purpose and location of safety
labels and other important information provided on the
equipment. Refer to Figure 1-1 on page 1-4 for Rating Plate.

Table 1-3: Label Icon Descriptions


No Label/Icon Purpose/Meaning Location
1. “ATTENTION” - Consult accompanying Rating Plate
documents” is intended to alert the user to refer
to the operator manual or other instructions
when complete information cannot be provided
on the label.

1-4 Invenia ABUS 2.0 – Release Notes


4700-0044-00 Rev. 4
Addendum

Table 1-3: Label Icon Descriptions


No Label/Icon Purpose/Meaning Location
2. TUV Rhineland Label: NRTL Listing and Rating Plate
Certification Mark is used to designate
conformance to nationally recognized product
safety standards. The Mark bears the name and/
or logo of the testing laboratory, product
category, safety standard to which conformity is
assessed, and a control number.

3. TUV Rhineland Listing Mark Monogram Rating Plate

4. Authorized European Representative address Rating Plate

5. Type BF Applied Part (man in the box) symbol is Rating Plate


in accordance with IEC 60417-5333.

6. Type/Class Label Used to indicate the degree of safety or Rating Plate


protection.
7. United States only Rating Plate
Prescription Requirement label

8. “General Warning Sign” Rating Plate


Possible shock hazard. Do not remove covers or
panels. No user serviceable parts are inside.
Refer servicing to qualified service personnel.
9. The CE Mark of Conformity indicates this Rating Plate
equipment conforms with the Council Directive
93/42/EEC.

10. Heavy equipment warning: To avoid possible Rating Plate


injury and equipment damage when transporting
from one area of use to another:
• Be sure the pathway is clear.
• Limit movement to a slow careful walk.
• Use two or more persons to move the
equipment on inclines or long distance.

Invenia ABUS 2.0 – Release Notes 1-5


4700-0044-00 Rev. 4
InveniaTM ABUS 2.0 Release Notes

Table 1-3: Label Icon Descriptions


No Label/Icon Purpose/Meaning Location
11. Equipment weight: 103 kg (227 lbs). Rating Plate

12. WEEE Symbol Rating Plate


This symbol indicates that waste electrical and
electronic equipment must not be disposed of as
unsorted municipal waste and must be collected
separately. Please contact an authorized
representative of the manufacturer for
information concerning the decommissioning of
your equipment.
13. Symbol indicating that the Instructions for Use Rating Plate
are supplied in electronic form (eIFU).

14. This product consists of devices that may Rating Plate


contain mercury, which must be recycled or
disposed of in accordance with local, state, or
country laws. Within this device the backlight
lamps in the monitor display contain mercury.
15. IP Code Indicates the degree of protection provided by Rating Plate
• IPX0 the enclosure per IEC60 529. Can be used in
• IPX1 operating room environment.
16. Patents US 7556602, CN100471457C Rating Plate

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

18. Unique Device Identification (UDI) Label. The Identification


UDI label consists of a series of alpha-numeric and Serial
characters and barcode which uniquely identify Number
the device as a medical device manufactured by Label
General Electric.

1-6 Invenia ABUS 2.0 – Release Notes


4700-0044-00 Rev. 4
Addendum

Table 1-3: Label Icon Descriptions


No Label/Icon Purpose/Meaning Location
19. Country of Origin. Identification
and Serial
Number
Label
“Mains OFF” indicates the power off position of Rear Panel
the mains power breaker.

“Mains ON” indicates the power on position of Rear Panel


the mains power breaker.

Power Switch Front Panel


CAUTION: This Power Switch
DOES NOT ISOLATE Mains Supply.

Single Use Only Single-Use


Stabilization
Membrane

Invenia ABUS 2.0 – Release Notes 1-7


4700-0044-00 Rev. 4
InveniaTM ABUS 2.0 Release Notes

Updates to EMC (Electromagnetic Compatibility) in the Safety Chapter

EMC (Electromagnetic Compatibility)

WARNING Portable RF communications equipment (including peripherals


such as antenna cables and external antennas) at frequencies
noted below should be used no closer than 30cm (12 inches) to
any part of the Invenia ABUS 2.0, including cables specified by
GE.
Otherwise, degradation of the performance of this equipment
could result.

EMC Performance

WARNING Use of this equipment adjacent to or stacked with other


equipment should be avoided because it could result in
improper operation. If such use is necessary, this equipment
and the other equipment should be observed to verify that they
are operating normally.

Table 1-4: Recommended separation distances between portable and mobile RF


communications equipment and this system

This system is intended for use in an electromagnetic environment in which radiated RF


disturbances are controlled. The customer or the user of this system can help prevent
electromagnetic Interference by maintaining a minimum distance between portable and mobile RF
communications equipment (transmitters) and this system as recommended below, according to the
maximum output power of the communications equipment.

Separation distance according to transmitter frequency

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

Where: d= separation distance in meters, P = rated power of the transmitter.


Rated Maximum Output
Power (P) of
Transmitter Watts (W) The separation distance in meters should be

0.01 0.12 0.12 0.23

0.1 0.37 0.37 0.74

1 1.17 1.17 2.33

1-8 Invenia ABUS 2.0 – Release Notes


4700-0044-00 Rev. 4
Addendum

Table 1-4: Recommended separation distances between portable and mobile RF


communications equipment and this system

10 3.69 3.69 7.38

100 11.7 11.7 23.3

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

WARNING Use of accessories, transducers and cables other than those


specified or provided by GE of this equipment could result in
increased electromagnetic emissions or decreased
electromagnetic immunity of this equipment and result in
improper operation.

Cable Specification

Table 1-5: Cable specification list

No Cable Name Type Length Cable Shielded

1 AC Power Cord AC 3m Unshielded

2 Ethernet Cable TP 3m Unshielded

3 Mouse Cable SIP 2m Shielded

Supplementary information:
*Note: AC = AC Power Port
TP = Telecommunication Port
SIP = Signal Input Port

Invenia ABUS 2.0 – Release Notes 1-9


4700-0044-00 Rev. 4
InveniaTM ABUS 2.0 Release Notes

Updates to EMC (Electromagnetic Compatibility) in the Safety Chapter


(continued)

Declaration of Emissions

Table 1-6: Declaration of Emissions

Guidance and manufacturer’s declaration - electromagnetic 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.

Emission Type Compliance Electromagnetic 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

Table 1-7: Declaration of Immunity Compliance Statement Supporting

Guidance and manufacturer's declaration - electromagnetic 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

IEC 60601-1-2 test IEC 60601-1-2 Electromagnetic


Immunity Type level Compliance Level Environment Guidance

IEC 61000-4-2 ± 8 kV contact Edition 4 series Floors should be wood,


Static discharge ± 8 kV air concrete, or ceramic tile. If
(ESD) ± 15 kV air ± 15 kV contact floors are covered with
synthetic material, the
relative humidity should be at
least 30%.

1-10 Invenia ABUS 2.0 – Release Notes


4700-0044-00 Rev. 4
Addendum

Table 1-7: Declaration of Immunity Compliance Statement Supporting

Guidance and manufacturer's declaration - electromagnetic 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

IEC 60601-1-2 test IEC 60601-1-2 Electromagnetic


Immunity Type level Compliance Level Environment Guidance

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 61000-4-5 ± 1 kV line-line Edition 4 series Mains power quality should


Surge Immunity ± 2 kV line-earth ± 1 kV line-line be that of a typical
± 2 kV line-earth commercial and/or hospital
environment.

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)

IEC 61000-4-8 30 A/m Edition 4 series Power frequency magnetic


Power frequency (50/ 30 A/m fields should be at levels
60 Hz) magnetic field characteristic of a typical
location in a typical
commercial and/or hospital
environment.

NOTE: UT is the AC mains voltage prior to application of the test level.

Invenia ABUS 2.0 – Release Notes 1-11


4700-0044-00 Rev. 4
InveniaTM ABUS 2.0 Release Notes

Table 1-7: Declaration of Immunity Compliance Statement Supporting

Guidance and manufacturer's declaration - electromagnetic 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

IEC 60601-1-2 test IEC 60601-1-2 Electromagnetic


Immunity Type level Compliance Level Environment Guidance

IEC 61000-4-6 3 Vrms Edition 4 series Portable and mobile RF


Conducted RF 150kHz to 80MHz 3 Vrms communications equipment
6 Vrms in ISM bands 150kHz to 80MHz should be used no closer to
between 150 kHz to 6 Vrms in ISM bands any part of this system,
80MHz between 150 kHz to including cables, than the
80MHz recommended separation
distance calculated from the
IEC 61000-4-3 3 V/m 3 V/m equation appropriate for the
Radiated RF EM 80 MHz - 2.7 GHz 80 MHz - 2.7 GHz frequency of the transmitter.
fields 80% AM 1 kHz 80% AM 1 kHz Recommended Separation
Distance (see Table 1-4)

(80 MHz to 800 MHz (see


Table 1-4)

(800 MHz to 2.7 GHz (see


Table 1-4)

where P is the maximum


output power rating of the
transmitter in watts (W)
according to the transmitter
manufacturer and d is the
recommended separation
distance in meters (m).
Field strengths from fixed RF
transmitters, as determined
by an electromagnetic site
survey, a should be less than
the compliance level in each
frequency range b.
Interference may occur in the
vicinity of equipment marked
with the symbol:

1-12 Invenia ABUS 2.0 – Release Notes


4700-0044-00 Rev. 4
Addendum

Table 1-7: Declaration of Immunity Compliance Statement Supporting

Guidance and manufacturer's declaration - electromagnetic 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

IEC 60601-1-2 test IEC 60601-1-2 Electromagnetic


Immunity Type level Compliance Level Environment Guidance

IEC 61000-4-3 9 V/m to 28 V/m 9 V/m to 28 V/m WARNING: Portable RF


Proximity fields from spot frequencies spot frequencies communications equipment
RF wireless 385 MHz: 27 V/m 385 MHz: 27 V/m (including peripherals such
communications 450 MHz: 28 V/m 450 MHz: 28 V/m as antenna cables and
equipment 710 MHz: 9 V/m 710 MHz: 9 V/m external antennas) at
745 MHz: 9 V/m 745 MHz: 9 V/m frequencies noted below
780 MHz: 9 V/m 780 MHz: 9 V/m should be used no closer
810 MHz: 28 V/m 810 MHz: 28 V/m than 30cm (12 inches) to any
870 MHz: 28 V/m 870 MHz: 28 V/m part of the Invenia ABUS 2.0,
930 MHz: 28 V/m 930 MHz: 28 V/m including cables specified by
1720 MHz: 28 V/m 1720 MHz: 28 V/m GE. Otherwise, degradation
1845 MHz: 28 V/m 1845 MHz: 28 V/m of the performance of this
1970 MHz: 28 V/m 1970 MHz: 28 V/m equipment could result.
2450 MHz: 28 V/m 2450 MHz: 28 V/m Minimum separation
5240 MHz: 9 V/m 5240 MHz: 9 V/m distances for higher
5500 MHz: 9 V/m 5500 MHz: 9 V/m IMMUNITY TEST LEVELS
5785 MHz: 9 V/m 5785 MHz: 9 V/m shall be calculated using the
PM 18 Hz or 217 Hz PM 18 Hz or 217 Hz (50% following equation:
(50% duty cycle) duty cycle)

Where P is the maximum


power in W, d is the
minimum separation
distance in m, and E is the
IMMUNITY TEST LEVEL in
V/m.

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.

Invenia ABUS 2.0 – Release Notes 1-13


4700-0044-00 Rev. 4
InveniaTM ABUS 2.0 Release Notes

Table 1-8: Spot Frequencies for IEC 61000-4-3


Proximity fields from RF wireless communications equipment

Test Maximum Immunity


frequency Band Power Distance Test Level
(MHz) (MHz) Service Modulation (W) (m) (V/m)

385 380 - 390 TETRA 400 Pulse modulation 1.8 0.3 27


18 Hz

450 430 - 470 GMRS 460, FM ± 5 kHz 2 0.3 28


FRS 460 deviation
1 kH sine

710 704 - 787 LTE Band Pulse modulation 0.2 0.3 9


13, 17 217 Hz
745

780

810 800 - 960 GSM 800/ Pulse modulation 2 0.3 28


900 18 Hz
870 TETRA 800
iDEN 820
930 CDMA 850
LTE Band 5

1720 1700 - GSM 1800; Pulse modulation 2 0.3 28


1990 CDMA 1900; 217 Hz
1845 GSM 1900;
DECT; LTE
1970
Band 1, 3, 4,
25; UMTS

2450 2400 - Bluetooth, W Pulse modulation 2 0.3 28


2570 LAN, 802.11 217 Hz
b/g/n, RFID
2450, LTE
Band 7

5240 5100 - WLAN Pulse modulation 0.2 0.3 9


5800 802.11 a/n 217 Hz
5500

5785

1-14 Invenia ABUS 2.0 – Release Notes


4700-0044-00 Rev. 4
Notes and Workarounds

Notes and Workarounds

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.

Invenia ABUS 2.0 – Release Notes 1-15


4700-0044-00 Rev. 4
InveniaTM ABUS 2.0 Release Notes

1-16 Invenia ABUS 2.0 – Release Notes


4700-0044-00 Rev. 4
1-2 Invenia ABUS 2.0 – Release Notes
4700-0044-00 Rev. 4

You might also like