LOGIQ E10s Operating Directions sw ver R3.x Rev 4 Nov 2021

Regulatory Requirement This product complies with regulatory requirements of the 2017/745 EU Medical Device Regulation concerning medical devices.

First CE Marked in 2021. This manual is a reference for the LOGIQ E10s. It applies to all versions of Software Version R3 Revision x.x for the LOGIQ E10s ultrasound system.

GE P.O. Box 414, Milwaukee, Wisconsin 53201 U.S.A. (Asia, Pacific, Latin America, North America) GE Healthcare GmbH Beethovenstrasse 239 Postfach 11 05 60 D-42655 Solingen GERMANY TEL: 49 212.28.02.208; FAX: 49 212.28.02.380

Revision History Reason for Change DATE (YYYY/MM/DD)

REV

REASON FOR CHANGE

Rev. 2

2021/07/06

Initial releae

Rev. 3

2021/09/09

FDA Update

Rev. 4

2021/11/23

Version R3 Revision 1.x Updates

List of Effective Pages

PAGE NUMBER

REVISION NUMBER

PAGE NUMBER

REVISION NUMBER

Title Page

Rev. 4

Regulatory Requirements

Rev. 4

Revision History

Rev. 4

Notes and Workarounds

Rev. 4

Please verify that you are using the latest revision of this document. Information pertaining to this document is maintained on MyWorkshop. 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.

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LOGIQ E10s – Release Notes Direction 5862474 -1EN English Rev. 4

Regulatory Requirements

Authorized EU Representative European registered place of business: GE Medical Systems SCS 283 rue de la Minière 78530 BUC, France

Manufacturer GE Ultrasound Korea, Ltd. 9, Sunhwan-ro 214beon-gil, Jungwon-gu, Seongnam-si, Gyeonggi-do, KOREA

Full Listing For a full listing of regulatory requirements, see the LOGIQ E10s Basic User Manual, Direction 5860662-1xx.

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Chapter 1 LOGIQ E10s R3.x

Release Notes

ATTENTION LOGIQ E10s USERS: This document contains information concerning the use of your LOGIQ E10s ultrasound system. Precautions and instructions are included that supplement the Basic User Manual and address specific concerns related to the software versions cited above. Keep this document with the Basic User Manual and have all users become familiar with its contents and organization before using your system under these software versions.

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LOGIQ E10s R3.x Release Notes

Addendum

Overview The content in these Release Notes includes an Addendum to the Basic User Manual, Direction 5860662-1xx. Important system Notes and Workarounds are also provided. Information included in these Release Notes supersedes Basic User Manual and Basic Service Manual content.

Updates to the Basic User Manual The following are updates/changes to the Basic User Manual:

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•

Manual Probe Test

•

Restore Region Imaging Presets

•

B-Flow Visualization Probes

•

Strain Elastography Clinical Applications

•

System Data - Depth

•

Measurement Bias Information Tables - ML4-20-D/ ML4-20VN-D

•

Device Labels

•

Wireless LAN (WLAN) Specifications

•

Preset Restore User Interface Corruption

•

Reusable Accessory Cleaning

LOGIQ E10s – Release Notes Direction 5862474 -1EN English Rev. 4

Addendum Manual Probe Test When “Enable Automatic Probe Diagnostics” is selected on the Utility->Admin page, the Probe Test utility appears on the B-Mode Touch Panel Page 2 (see Figure 1-1). (The Probe Test utility does not appear while Scan Assistant is running.) A manual probe test can be run with this utility on the following probes: C1-6-D, IC5-9-D, M5Sc-D, ML6-15 and RIC5-9-D.

Figure 1-1.

Probe Test

Run Probe Test Ensure the probe lens surface is clean and free of dirt, water or coupling gel before beginning probe test. 1. Select the Probe Test button on the Touch Panel (see Figure 1-1). 2. A pop-up appears specifying to ensure the probe lens surface is clean. If the lens is clean, select Yes on the pop-up (see Figure 1-2). The probe test takes approximately 5 to 10 seconds.

Figure 1-2.

LOGIQ E10s – Release Notes Direction 5862474 -1EN English Rev. 4

Probe Test Pop-up

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LOGIQ E10s R3.x Release Notes Run Probe Test (continued) 3. When the probe test is complete, a pop-up displays specifying if the probe “Passed” (1) or “Failed” (2) the test (see Figure 1-3). If the probe passed the test, continue using the probe. If the probe failed the test, follow the instructions on the pop-up.

Figure 1-3.

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Probe Test Pass or Fail Pop-ups

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Addendum Restore Region Imaging Presets The LOGIQ E10s R3 system supports only two region imaging presets: Europe and None. LOGIQ E10s R2 region presets are not transferred to the LOGIQ E10s R3 if the presets were configured on the R2 system as: Americas, China, Europe or Japan. •

R2 imaging presets configured as Americas, China or Japan do not transfer to R3 imaging presets.

•

R2 imaging presets configured as Europe do not transfer to R3 imaging presets configured as Europe. The R3 Europe default imaging presets will remain.

When restoring imaging presets using Detailed Restore, if the pop-up message below appears, the imaging settings from R2 regional imaging presets are not compatible with R3 and will not be transferred.

Figure 1-4. Region Preset Error

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LOGIQ E10s R3.x Release Notes B-Flow Visualization Probes The note below contains the updated list of probes available for B-Flow Visualization: NOTE:

Available for C1-6-D, C1-6VN-D, C2-9-D, C2-9VN-D, L2-9-D, L2-9VN-D, L3-12-D, ML4-20-D, ML4-20VN-D, L6-24-D, L8-18i-D, M5Sc-D, C3-10-D, C2-7-D, C2-7VN-D and ML6-15-D probes.

Strain Elastography Clinical Applications The table below updated probes for the Breast and MSK applications: Table 1-1: Application

Clinical Applications

Compare the suspicious lesion with:

Probe

Breast

A fatty area in the breast or the average rounding breast tissue.

• L2-9-D/L2-9VN-D • L8-18i-D • ML4-20-D/ML4-20VN-D • ML6-15-D • L3-12-D

MSK

A normal area in the same part of the body.

• C1-6-D/C1-6VN-D • C2-9-D/C2-9VN-D • L2-9-D/L2-9VN-D • L8-18i-D • L3-12-D • ML4-20-D/ML4-20VN-D • ML6-15-D

System Data The table below is updated with actual system depth:

Features/Specifications Table 1-2:

Physical Attributes

Dimensions and Weight (for Transport) • Height: 1300mm, 51 in • Width: 585mm, 23 in • Depth: 900.9mm, 35.5 in • Weight (with HDU monitor): 118 kg, 260 lb. • Weight (with OLED Monitor): 115 kg, 254 lb.

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Addendum Device labels The Multi Caution Label and Rating plate are changed in Figure 1-5, with a description in Table 1-3. (Reference the “Device Labels” section in Chapter 2 of the Basic User Manual for more information.)

Figure 1-5.

Rear Panel Label Location

Label Icon Description Table 1-3: Item 1.

Label Icons (Rear of Console)

Label/Icon

Purpose/Meaning GE Cares Label (US/Canada systems only)

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LOGIQ E10s R3.x Release Notes Table 1-3: Item

Label Icons (Rear of Console) (Continued)

Label/Icon

Purpose/Meaning

2. Monitor Label: GE created

How to lock system prior to transport

DO NOT place a finger, hand or any object on the joint of the monitor or monitor arm to avoid injury when moving the monitor and monitor arm.

3.

United States only Prescription Device label 21 CFR 801.109 and Alternative to Certain Prescription Device Labeling Requirements Guidance to Industry 1/2/2000 U.S. Food&Drug Administration modified by General Electric for clarity that this is for the USA

4.

UL conformity mark according to ANSI/AAMI ES60601-1:2005/ (R)2012, CAN/CSA-C22.2 No. 60601-1:14. N/A- by certification body

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Addendum Table 1-3: Item 5.

Label Icons (Rear of Console) (Continued)

Label/Icon RoHS Label–China systems only (shown for country specific label)

Purpose/Meaning China Electronic Industry Standard SJ/T11364-2014 Indicates the presence of hazardous substance(s) above the maximum concentration value. Maximum concentration values for electronic information products, as set by the People’s Republic of China Electronic Industry Standard SJ/T11364-2006, include the hazardous substances of lead, mercury, hexavalent chromium, cadmium, polybrominated biphenyl (PBB), and polybrominated diphenyl ether (PBDE). “20” indicates the number of years during which the hazardous substance(s) will not leak or mutate so that the use of this product will not result in any severe environmental pollution, bodily injury, or damage to any assets. Indicates the presence of hazardous substance(s) above the maximum concentration value. Maximum concentration values for electronic information products, as set by the People’s Republic of China Electronic Industry Standard SJ/T11364-2006, include the hazardous substances of lead, mercury, hexavalent chromium, cadmium, polybrominated biphenyl (PBB), and polybrominated diphenyl ether (PBDE). “10” indicates the number of years during which the hazardous substance(s) will not leak or mutate so that the use of this product will not result in any severe environmental pollution, bodily injury, or damage to any assets.

6.

Follow instruction for use. IEC 60601-1:2005+A1:2012 Annex D.1 and ISO 7010-M002

7.

“General Warning Sign” Possible shock hazard. Do not remove covers or panels. No user serviceable parts are inside. Refer servicing to qualified service personnel. Standard: ISO 7010-W001.

8.

Use two people to transport system on inclines. This label also indicates the system weight. To avoid possible 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. GE created

9.

This WEEE 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. Standard: EN 50419. WEEE Directive 2012/19/EU

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LOGIQ E10s R3.x Release Notes Table 1-3: Item

Label Icons (Rear of Console) (Continued)

Label/Icon

Purpose/Meaning

10.

Type BF Applied Part (man in the box) symbol is in accordance with IEC 60417-5333.

11.

This product is a medical device.

12.

Symbol indicating that the Instructions for Use are supplied in electronic form. ISO 7000-3500

13.

Do not use the following devices near this equipment: cellular phone, radio receiver, mobile radio transmitter, radio controlled toy, broadband power lines, etc. Use of these devices near this equipment could cause this equipment to perform outside the published specifications. Keep power to these devices turned off when near this equipment. ISO 7010-P013

14.

DO NOT push the system. Use the handle to push/pull the system, e.g., DO NOT use the monitor. Failure to do so may cause serious injury or system damage. IEC 60601-1:2005+A1:2012 Annex D.2 and ISO 7010-P017

15.

The CE Mark of Conformity indicates this equipment conforms with the European Medical Device Regulation 2017/745 European Medical Device Regulation 2017/745

16.

Authorized European Representative address

17.

The MR Unsafe label is to warn that this Ultrasound System poses risks to the patient, medical staff or other persons within the MR environment and that the Ultrasound system should remain outside of the MR environment.

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Addendum Table 1-3: Item 18.

Label Icons (Rear of Console) (Continued)

Label/Icon

Purpose/Meaning Federal Communications Commission Identification label - on LOGIQ E10s equipped with Wireless LAN

Non-Ionizing Electromagnetic Radiation IEC 60417-5140 IEC TR 60878-5140 Federal Communications Commission Identification label - on LOGIQ E10s equipped with Wireless LAN Canada Certification label - on LOGIQ E10s equipped with Wireless LAN Malaysian Communications and Multimedia Commission symbol. Number correspond to GE importing company (GEHC) on LOGIQ E10s equipped with Wireless LAN

ANATEL Certification label for Brazil - on LOGIQ E10s equipped with Wireless LAN

Infocomm Development Authority of Singapore (IMDA) standard - on LOGIQ E10s equipped with Wireless LAN

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LOGIQ E10s R3.x Release Notes Table 1-3: Item 19.

Label/Icon

Label Icons (Rear of Console) (Continued) Purpose/Meaning Possible shock hazard. Do not remove covers or panels. No user serviceable parts are inside. Refer servicing to qualified service personnel. • USB 3.0 Ports • Ethernet Connection • S-Video Connector • HDMI Connector

“Equipotentiality” indicates the terminal to be used for connecting equipotential conductors when interconnecting (grounding) with other equipment. Connection of additional protective earth conductors or potential equalization conductors is not necessary in most cases and is only recommended for situations involving multiple equipment in a high-risk patient environment to provide assurance that all equipment is at the same potential and operates within acceptable leakage current limits. An example of a high-risk patient would be a special procedure where the patient has an accessible conductive path to the heart such as exposed cardiac pacing leads. IEC60417-5021 IEC 60601-1:2005+A1:2012 Annex D.1 and IEC 60417-5021 Mains OFF: indicates the power off position of the mains power breaker. IEC 60601-1:2005+A1:2012 Annex D.1 and IEC 60417-5008 Mains ON: indicates the power on position of the mains power breaker. IEC 60601-1:2005+A1:2012 Annex D.1 and IEC 60417-5007

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Addendum Table 1-3: Item 20.

Label Icons (Rear of Console) (Continued)

Label/Icon

Purpose/Meaning Every system has a unique marking for identification, the Unique Device Identification (UDI) Label. The UDI label consists of a series of alpha-numeric characters and barcode which uniquely identify the LOGIQ E10s system as a medical device manufactured by General Electric. Scan or enter the UDI information into the patient health record as required by country-specific laws. UDI Human Readable Label Text: Global Trade Item Number, GTIN, Manufacturing Date, Serial Number UDI Symbol and Data Matrix

System Voltage (~100-240VAC) Frequency Power Rating Alternating Current symbol is in accordance with IEC 60417-5032 Catalog/Model Number. Standard: ISO 7000-2493.

Serial Number. Standard: ISO 7000-2498.

Legal Manufacturer’s name and address. Standard: ISO 7000-3082.

Date of manufacture YYYY-MM. Standard: ISO 7000-2497.

Eurasian Conformity mark; the single conformity mark for circulation of products on the markets of member-states of the Customs Union. This product passed all conformity assessment (approval) procedures that correspond to the requirements of applicable technical regulations of the Customs Union. National standards of the Russian Federation and CIS countries The CE Mark of Conformity indicates this equipment conforms with the European Medical Device Regulation 2017/745 European Medical Device Regulation 2017/745

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LOGIQ E10s R3.x Release Notes Measurement Bias Information Tables The ML4-20-D/ML4-20VN-D Measurement Bias Information Tables are added below. (Reference the “Shear Wave Elastography” section in Chapter 13 of the Basic User Manual for more information.)

Figure 1-6.

ML4-20-D/ML4-20VN-D Measurement Bias Information (Velocity on the left and Stiffness on the right)

Wireless LAN (WLAN) Specifications Intel declaration of conformity You can find the Intel Declaration of Conformity at this web link: https://www.intel.com/content/dam/support/us/en/documents/ network-and-i-o/wireless-networking/ 9260NGW-EU-RED-DoC.pdf

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