LOGIQ E10 Release Notes Sw Ver R1 Rev 5.x

Regulatory Requirement This product complies with regulatory requirements of the following European Directive 93/42/EEC concerning medical devices.

0459 First CE Marked in 2018. This manual is a reference for the LOGIQ E10. It applies to all versions of the Software Version R1 Revision 5.x software for the LOGIQ E10 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. 1

2018/02/06

Initial Release

Rev. 2

2018/02/26

Rating Plate Update

Rev. 3

2018/06/28

R1.2 Update

Rev. 4

2018/09/14

R1.3 Update

Rev. 5

2018/12/19

EMC, Probe Reprocessing Instruction Update

Rev. 6

2019/03/21

R1.5 Update

List of Effective Pages

PAGE NUMBER

REVISION NUMBER

PAGE NUMBER

REVISION NUMBER

Title Page

Rev. 6

Addendum

Rev. 6

Revision History

Rev. 6

Notes and Workarounds

Rev. 6

Regulatory Requirements

Rev. 6

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.

LOGIQ E10 – Release Notes Direction 5750002-1EN English Rev. 6

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LOGIQ E10 – Release Notes Direction 5750002-1EN English Rev. 6

Regulatory Requirements

Conformance Standards The following classifications are in accordance with the IEC/ EN 60601-1:6.8.1: •

According to 93/42/EEC Medical Device Directive, this is Class IIa Medical Device.

•

According to IEC/EN 60601-1, Equipment is Class I, Type B with BF or CF Applied Parts.

•

According to CISPR 11, LOGIQ E10 system 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 Safety chapter of the Basic User Manual. Authorized EU Representative European registered place of business: GE Medical Systems SCS 283 rue de la Minière 78530 BUC, France

LOGIQ E10 – Release Notes Direction 5750002-1EN English Rev. 6

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Conformance Standards (continued) •

•

International Electrotechnical Commission (IEC). •

IEC/EN 60601-1 Medical Electrical Equipment, Part 1 General Requirements for Safety.

•

IEC/EN 60601-1-2 Electromagnetic disturbances Requirements and tests.

•

IEC 60601-1-6 (Usability), EN 1041 (Information supplied with medical devices)

•

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), an independent testing laboratory. 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.

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•

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, labelling and information to be supplied -- Part 1: General requirements

LOGIQ E10 – Release Notes Direction 5750002-1EN English Rev. 6

Certifications •

General Electric Medical Systems is ISO 13485 certified.

Original Documentation •

The original document was written in English.

Country Specific Approval •

KOREA KFDA License 18-4342

Manufacturer GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC 9900 Innovation Drive Wauwatosa, WI 53226 U.S.A.

Importer Information •

Turkey

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LOGIQ E10 – Release Notes Direction 5750002-1EN English Rev. 6

Chapter 1 LOGIQ E10 Version R1 Revision 5.x Release Notes ATTENTION LOGIQ E10 USERS: This document contains information concerning the use of your LOGIQ E10 ultrasound system. Precautions and instructions are included that supplement the Basic User Manual and Basic Service Manual and address specific concerns related to Software Version R1 Revision 5.x. Keep this document with the Basic User Manual and Basic Service Manual and have all users become familiar with its contents and organization before using your system under this software version.

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LOGIQ E10 Version R1 Revision 5.x Release Notes

Addendum

Overview The content in these Release Notes includes an Addendum to the Basic User Manual, Direction 5750001-1xx and Basic Service Manual, Direction 5750007-1EN (not translated). Important system Notes and Workarounds are also provided. Information included in these Release Notes supersedes Basic User Manual and Basic Service Manual content.

Updates Made to the LOGIQ E10 Basic User Manual The following updates/changes have been incorporated into the Basic User Manual:

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•

Privacy and Security -- See Chapters 3, 10, 12, and 13.

•

Vulnerability Scan Mode -- See Chapter 13.

•

IOTA, Bypass Graft Anastomosis Graph -- See Chapter 8.

•

Koios and Breast Productivity -- See Chapters 10 and 13.

•

Probe Reprocessing Update -- See Chapter 11.

•

Console Reprocessing Update -- See Chapter 12.

•

Shear Wave on ML6-15-D Probe -- See Chapter 13.

•

Loading Windows Patches -- See Chapter 12

LOGIQ E10 – Release Notes Direction 5750002-1EN English Rev. 6

Addendum Additional Updates to the Basic User Manual Privacy and Security Updates Default Security Level Update

When you initially log into the LOGIQ E10, you will need to set the Default Security Level to be used by all system users. When you logon, you can either, 1. Select the Default Security Level (Lowest) by pressing “Accept Default”; or, 2. Select a different Default Security Level from the pull-down menu, then press “Choose Security Level”. You will then be prompted to create a password based on the security level’s requirements. •

Medium

•

High (Recommended)

•

Highest

Figure 1-1. NOTE:

Logon > Select Default Security Level

Refer to the Basic User Manual for in-depth descriptions of each of these Default Security Level settings.

LOGIQ E10 – Release Notes Direction 5750002-1EN English Rev. 6

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LOGIQ E10 Version R1 Revision 5.x Release Notes Privacy and Security Updates (continued) USB Indicator in the Status Indicator

A USB Status Indicator has been added to the system. If the USB External Media has been deactivated, the following icon appears at the bottom of the display.

Figure 1-2.

USB Media Deactivated Indicator

The USB Media activation/deactivation can be found on the Utility--> Admin--> System Admin page:

Figure 1-3. Advanced Security Option -Vulnerability Scan Mode Note

USB External Media Activation/Deactivation

For the Scheduled Vulnerability Scan Mode to be triggered, the system will have to be in an idle state for a minimum of 30 minutes. This means that if a user enables the scheduled scan mode for 12:00pm, the user will be prompted whether they would like to enable the Scheduled Scan Mode at 12:30pm. If the user selects to proceed, then the system will be put into the Scheduled Scan Mode at 12:30pm.

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LOGIQ E10 – Release Notes Direction 5750002-1EN English Rev. 6

Addendum Privacy and Security Updates (continued) Encryption Update

Additional information has been provided for the Encryption page.

Figure 1-4. Customer Drive Information

Additional Encryption Page Info

Lock status: Encryption status of the Patient Archive drive Conversion status: Encryption progress of the conversion of the customer’s Patient Archive drives (log and preset drives, patient drive, DVR drive). Fully Encrypted = Customer Drive Encryption Complete Protected status: Indicates whether the customer drives (all partitions, D, E, and V) are protected by encryption.

Total System Encryption Progress

Encryption Status Bar: The Progress Bar provides an overall encryption progress (both Customer and System drives). In the example above (51%), at this point in the encryption process, Customer data encryption is done; GE drive data is now being encrypted. •

NOTE:

50% - The progress bar jumps to 50% when the Customer drive encryption has completed and then slowly climbs as the System drive encryption completes.

User can print encryption keys into a DICOM image. The print needs to be set up to print a full screen. See Utility for print configuration.

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LOGIQ E10 Version R1 Revision 5.x Release Notes Probe Cleaning and Disinfecting Notes

WARNING

Ultrasound transducers can easily be damaged by improper handling and by contact with certain chemicals. Failure to follow these precautions can result in serious injury and equipment damage. •

Do not immerse the probe into any liquid beyond the level specified for that probe. Never immerse the transducer connector or probe adapters into any liquid.

•

Avoid mechanical shock or impact to the transducer and do not apply excessive bending or pulling force to the cable.

•

Transducer damage can result from contact with inappropriate coupling or cleaning agents:

•

WARNING

•

Do not soak or saturate transducers with solutions containing alcohol, bleach, ammonium chloride compounds or hydrogen peroxide (except in the case of using Trophon’s hydrogen peroxide).

•

Avoid contact with solutions or coupling gels containing mineral oil or lanolin

•

Avoid temperatures above 60°C (except with Trophon for approved probes).

Inspect the probe prior to use for damage or degeneration to the housing, strain relief, lens and seal. Do not use a damaged or defective probe.

Ultrasound transducers can easily be damaged by improper handling and by contact with certain chemicals. Failure to follow these precautions can result in serious injury and equipment damage. Use only germicides that are listed in the Probe Care Card enclosed with the probe. In addition, refer to the local / national regulations.

WARNING

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Do not steam, heat autoclave on general surface probes.

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Addendum Probe Cleaning and Disinfecting Notes (continued)

CAUTION

CREUTZFIELD-JACOB DISEASE Neurological use on patients with this disease must be avoided. If a probe becomes contaminated, there is no adequate disinfecting means.

Biological Hazard

CAUTION

DO NOT expose the system/probe connector to any moisture or liquids.

CAUTION

Take extra care when handling the lens face of the Ultrasound transducer. The lens face is especially sensitive and can easily be damaged by rough handling. NEVER use excessive force when cleaning the lens face.

CAUTION

In order for liquid chemical germicides to be effective, all visible residue must be removed during the cleaning process. Thoroughly clean the probe, as described earlier before attempting disinfection. You MUST disconnect the probe from the LOGIQ E10 prior to cleaning/disinfecting the probe. Failure to do so could damage the system. DO NOT soak probes in liquid chemical germicide for longer than is stated by the germicide instructions for use. Extended soaking may cause probe damage and early failure of the enclosure, resulting in possible electric shock hazard.

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LOGIQ E10 Version R1 Revision 5.x Release Notes Probe Cleaning and Disinfecting Notes (continued)

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CAUTION

Avoid cross-contamination, follow all infection control policies established by your office, department or hospital as they apply to personnel and equipment.

CAUTION

•

Do not use paper products or products that are abrasive when cleaning the probe. They damage the soft lens of the probe.

•

Before storing the probes, ensure that they are thoroughly dry. If it is necessary to dry the probe after cleaning, blot the probe with a soft cloth.

NOTE:

Cleaning products should be as close to neutral PH as possible. Any gel, cleaning, or disinfectant products containing concentrations, surfactants, methanol, ethanol, benzyl or methyl alcohol, mineral oil, lubricant oil, oil-based lotions, acetone, ammonia, anhydrous ammonia, iodine, iodine compounds, acids with 5PH or greater may damage or discolor your probe. Ultrasounic cleaning is not approved for GE probes.

NOTE:

DO NOT re-use cloths or wipes. Soap, detergents, or enzymatic cleaners should be used in accordance with the manufacturer’s instructions. GE is not responsible for damage incurred during the cleaning process for products which no material compatibility evaluation has been conducted.

LOGIQ E10 – Release Notes Direction 5750002-1EN English Rev. 6

Addendum Updates to the Basic Service Manual The following updates have been made: •

Application Software Part Number Update

•

Service Desktop Update

•

Privacy and Security Updates

•

Updated Replacement Procedures

•

Base Image and Software Load Procedure Update

Application Software Part Number Update Table 1-1: Description

LOGIQ E10 Software Part Number

FRU?

LOGIQ E10 R1.1.2 Software Thumb Drive Assembly • Application Software (5767892-2) • Base Image Load (5746646)

5793701-2

No

LOGIQ E10 R1.1.5 Software Thumb Drive Assembly • Application Software (5767892-3) • Base Image Load (5746646)

5793701-3

Yes

LOGIQ E10, E11, E20 R1.3.0 Software Thumb Drive Assembly • Application Software (5767892-5) • Base Image Load (5746646-3)

5793701-5

Yes

LOGIQ E10, E11, E20 R1.5.0 Software Thumb Drive Assembly • Application Software (5767892-6) • Base Image Load (5812619)

5793701-6

Yes

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LOGIQ E10 Version R1 Revision 5.x Release Notes Service Desktop Update The following updates have been made to the Service Desktop.

Software Reload Page Update

•

Software Reload Page Update

•

User Interface Modifications

•

R1.3 to R1.5 Upgrade Agent Quarantine

•

Battery Status

•

Disable Remote Connectivity

•

Secure Delete

When you reload software with Encryption enabled, 1. Enter Disruptive Mode.

Figure 1-5. 2. Select to reload software.

Figure 1-6.

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Software Reload

LOGIQ E10 – Release Notes Direction 5750002-1EN English Rev. 6

Addendum Service Desktop Update (continued) 3. A software reload confirmation message appears asking you to confirm that you want to reload software onto an encrypted drive (Encryption is ON. Disks are unlocked automatically or Key is stored on USB / password is entered manually).

Figure 1-7. Software Reload Confirmation Dialog NOTE:

If the disks are encrypted manually and the disks are locked, software reload fails with the following error message. In this case, the customer needs to unlock the drives using either a recovery key or password.

Figure 1-8.

LOGIQ E10 – Release Notes Direction 5750002-1EN English Rev. 6

Software Reload, Disks Locked

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LOGIQ E10 Version R1 Revision 5.x Release Notes Service Desktop Update (continued) User Interface Modifications

R1.3 to R1.5 Upgrade Agent Quarantine

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The following updates have been made to the Common Service Desktop: •

Refresh Icon in the upper, right-hand corner of the title bar.

•

The footer now indicates copyright information.

•

On the Run Diag Page, the Diagnostic Result Summary has been updated.

•

There’s a new utility page: Resolve Agent Quarantine.

Service configurations cannot be imported from R1.3 software, or from previous versions of software. When upgrading from R1.3 or previous software versions, the InSite Agent will be placed in a quarantined state. You need to resolve this quarantine state by selecting Utility--> Resolve Agent Quarantine.

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