General Electric Ultrasound Common Service Information N 490042-02 Rév B

Download

Technical Publication

Ultrasound System

Common Service Information Direction Number: Direction 5444964-100 English

Rev. 5

BASIC SERVICE DOCUMENTATION. COPYRIGHT GENERAL ELECTRIC COMPANY.

Manufacturer:

GE Medical Systems www.gehealthcare.com

Revision History

Reason for Change

DATE

REVISION

1 2012/01/30 Initial Release 2 2013/12/16 Updated according to feedback. 3 2014/11/04 Adding New Products 4 2016/01/29 Updated according to feedback. 5 2018/08/21 Updated according to feedback.

(YYYY/MM/DD)

List of Effective Pages (LOEP)

REASON FOR CHANGE

REVISION

PAGE NUMBER

Title Page Rev. 5 Table of Contents Rev. 5 Revision History Rev. 5 Chapters 1 through 4 Rev. 5 Important precautions Rev. 5 Index Rev. 5

NUMBER PAGE NUMBER

REVISION

NUMBER

Please verify that you are using the latest revision of this document. Information pertaining to this document is maintained on ePDM (GE Healthcare electronic Product Data Management). If you need to know the latest re vision, 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. Note: T esting requirement s and descriptions of the safety equipment in this Common Service Inform at ion (CSI) Ma nu al su pe rs ed es the product’s Service Manual if that manual’s publication date precedes the date of this CSI manual.

Ultrasound System – Common Service Information i-1 Direction 5444964-100 English Rev. 5

Important precautions

i-2 Ultrasound System – Common Service Information

Direction 5444964-100 English

Rev. 5

Translation policy

Ultrasound System – Common Service Information i-3 Direction 5444964-100 English Rev. 5

i-4 Ultrasound System – Common Service Information

Direction 5444964-100 English

Rev. 5

Ultrasound System – Common Service Information i-5 Direction 5444964-100 English Rev. 5

i-6 Ultrasound System – Common Service Information

Direction 5444964-100 English

Rev. 5

Ultrasound System – Common Service Information i-7 Direction 5444964-100 English Rev. 5

i-8 Ultrasound System – Common Service Information

Direction 5444964-100 English

Rev. 5

Ultrasound System – Common Service Information i-9 Direction 5444964-100 English Rev. 5

i-10 Ultrasound System – Common Service Information

Direction 5444964-100 English

Rev. 5

Ultrasound System – Common Service Information i-11 Direction 5444964-100 English Rev. 5

i-12 Ultrasound System – Common Service Information

Direction 5444964-100 English

Rev. 5

Ultrasound System – Common Service Information i-13 Direction 5444964-100 English Rev. 5

Damage in transportation

All packages should be closely examined at time of delivery. If damage is apparent, write “Damage in Shipment” on ALL copies of the freight or express bill BEFORE delivery is accepted or “signed for” by a GE representative or hospital receiving agent. Whether noted or concealed, damage MUST be reported to the carrier immediately upon discovery, or in any event, within 14 days after receipt, and the contents and containers held for inspection by the carrier. A transport ation company will not pay a claim for damage if an inspection is not requeste d with in th is 14-day period.

i-14 Ultrasound System – Common Service Information

Direction 5444964-100 English

Rev. 5

Certified electrical contractor statement - For USA Only

All electrical installations that are preliminary to positioning of the equipment at the site prepared for the equipment shall be performed by licensed electrical contractors. Other connections between pieces of electrical equipment, calibrations, and testing shall be performed by qualified GE personnel. In per for m ing all electrical work on these products, GE will use its own specially trained field engineers. All of GE’s electrical work on these products will comply with the requirements of the applicable electrical codes.

The purchaser of GE equipment shall only utilize qualified personnel (i.e. GE field engineers, personnel of third-party service companies with equivalent training, or licensed electricians) to perform electrical servicing on the equipment.

Ultrasound System – Common Service Information i-15 Direction 5444964-100 English Rev. 5

Omission and errors

If there are any omissions, errors or suggest ion s for imp ro vin g this documentation, contact the GE Ultrasound Global Documentation Group with specific information listing the system type, manual title, part number or direction numbe r, revision number, page number and suggestion details.

Mail the

information to:GEService Documentation

9900 Innovation Drive (RP-2156) WAUWATOSA, WI 53226 USA

GE employees should use Post-Market Qu a lity Ma na gem e nt (PQM) to report service documentation issues.

Service Safety Considerations

DANGER DANGEROUS VOL TAGES, CAP ABLE OF CAUSING DEATH, ARE PRESENT

IN THIS EQUIPMENT. USE EXTREME CAUTION WHEN HANDLING, TESTING AND ADJUSTING.

WARNING

Use all Personal Protection Equipment (PPE) such as gloves, safety shoes, safety glasses, and kneeling pads, to reduce the risk of injury.

For a complete review of all safety requirements, see: ‘Safety Information’ on page 2-1.

i-16 Ultrasound System – Common Service Information

Direction 5444964-100 English

Rev. 5

Legal notes

Trademarks

Copyrights

The contents of this publication may not be copied or duplicated in any form, in whole or in part, without prior written permission of GE.

GE makes no representations or warranties with respect to the information herein. In addition, the information is subject to change without notice. Every precaution has been taken in the preparation of this document. Nevertheless, GE assumes no responsibility for errors, omissions, or any damages, including special or consequential, resulting from the use of this information. GE will issue updates to this information periodically, as needed. If there are any questions regarding the information contained in this manual, please contact your GE Representative.

All products and their name brands are trademarks of their respective holders.

Ultrasound System – Common Service Information i-17 Direction 5444964-100 English Rev. 5

i-18 Ultrasound System – Common Service Information

Direction 5444964-100 English

Rev. 5

Translation policy - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-3 Damage in transportation - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-14 Certified electrical contractor statement - For USA Only - - - - - - - - - - - - i-15 Omission and errors - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-16 Service Safety Considerations - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-16 Legal notes - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-17 Trademarks - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-17 Copyrights - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-17

Table of Contents Chapter 1 — Overview

Content in this manual Product description

Overview of the Ultrasound System - - - - - - - - - - - - - - - - - - - - - - - - - - 1-3

Products Covered in this Manual

Chapter 2 — Safety Information

Overview

Contents in this chapter- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-2

Important conventions

Conventions used in book - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-3 Standard hazard icons - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-5

Product Icons

Label Icon Description- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-7 How to lock the Operator Panel prior to transport- - - - - - - - - - - - - - - - - 2-7

Safety considerations

Introduction - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-8 Human Safety - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-8 Mechanical safety- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-11 Electrical safety - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-16

Label locations

Product Labels - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-18

Dangerous procedure warnings

Warnings - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-19

Lockout/Tagout (LOTO)

LOTO Requirements- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-20

Returning probes and repair parts

Requirements for Returning Parts - - - - - - - - - - - - - - - - - - - - - - - - - - 2-21 User Responsibility- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-21

Ultrasound System – Common Service Information i-19 Direction 5444964-100 English Rev. 5

Electromagnetic compatibility (EMC)

What is EMC? - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-22 Compliance - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-22 Electrostatic discharge (ESD) prevention - - - - - - - - - - - - - - - - - - - - - 2-23

Chapter 3 — Site Preparations

Overview

Contents in this chapter- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-2

General Ultrasound system requirements

Contents in this section - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-3 Ultrasound system environmental requirements- - - - - - - - - - - - - - - - - - 3-3 Electrical requirements - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-5 EMI limitations - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-18 Probes environmental requirements - - - - - - - - - - - - - - - - - - - - - - - - - 3-20 Time and manpower requirements- - - - - - - - - - - - - - - - - - - - - - - - - - 3-20

Facility needs

Contents in this section - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-21 Purchaser responsibilities - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-21 Required facility needs - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-23 Desirable features- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-25

Chapter 4 — Care and Maintenance

Overview

Care and Maintenance - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-2 Contents in this chapter- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-2

Warnings

Warnings - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-3

Why do maintenance

Keeping records - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-4 Quality assurance- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-4

Maintenance task schedule

How often should maintenance tasks be performed? - - - - - - - - - - - - - - 4-5

System maintenance

Preliminary checks - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-6 Functional checks- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-7 Physical inspection - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-9 Cleaning - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-11 Probe maintenance- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-12

Using a Phantom

Phantoms - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-13

Electrical safety tests

Content in this section- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-14 Uninterrupted Power Supply (UPS) - - - - - - - - - - - - - - - - - - - - - - - - - 4-15 Safety test overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-16 Leakage current limits - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-19 Outlet test - wiring arrangement - USA and Canada- - - - - - - - - - - - - - 4-23 Grounding continuity - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-24 Chassis leakage current test - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-25 Isolated patient lead (source) leakage–lead to ground - - - - - - - - - - - - 4-29

i-20 Ultrasound System – Common Service Information

Direction 5444964-100 English

Rev. 5

Isolated patient lead (source) leakage–lead to lead - - - - - - - - - - - - - - 4-31 Isolated patient lead (sink) leakage-isolation test - - - - - - - - - - - - - - - - 4-33 Probe (Source) leakage current test- - - - - - - - - - - - - - - - - - - - - - - - - 4-35 Isolated Probe (Sink) Leakage-Isolation Test- - - - - - - - - - - - - - - - - - - 4-40

When there's too much leakage current …

AC/DC Fails- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-44 Chassis Fails - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-44 Probe Fails- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-45 Peripheral Fails - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-45 Still Fails - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-45 New Ultrasound system- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-45 ECG Fails - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-45

Ultrasound Equipment Quality Check (EQC and IQC)

Quality Checks - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-46

Index

Ultrasound System – Common Service Information i-21 Direction 5444964-100 English Rev. 5

i-22 Ultrasound System – Common Service Information

Direction 5444964-100 English

Rev. 5

Chapter 1

Overview

This Service Manual includes common service information for GE’s Ultrasound systems. The manual provides Installation, Safety, and Maintenance information.

Ultrasound System – Common Service Information 1-1 Direction 5444964-100 English Rev. 5

Overview

Content in this manual

The following topics are covered in this manual:

• Products covered in this manual. See Chapter 1 (this chapter).

• Safety Information. See Chapter 2.

• Site Preparations. See Chapter 3.

• Care and Maintenance. See Chapter 4.

1-2 Ultrasound System – Common Service Information

Direction 5444964-100 English

Rev. 5

Product description

Overview of the Ultrasound System

This Ultrasound System is a high performance digital ultraso und imaging system with total data management.

The fully digital architecture of the Ultrasound System allows optimal usage of all scanning modes and probe types throughout the full spectrum of operating frequencies.

Signal flows from the Probe Connector Panel through the Ultrasound system and finally to the monitor and peripherals.

System configuration is stored on the hard drive. All necessary software is loaded from the hard drive on power

up.

Product description

Ultrasound System – Common Service Information 1-3 Direction 5444964-100 English Rev. 5

Overview

Products Covered in this Manual

This Common Service Information (CSI) Manual is effective for the products listed in Table 1-1.

Testing requirements and descriptions of the safety equipment in this Common Service Information (CSI) Manual supersedes the product’s Service Manual if that manual’ s publication date is earlier than the date of this CSI manual.

Table 1-1: Products Covered in this Manua

U/S Product U/S Product U/S Product U/S Product U/S Product

Invenia ABUS Vivid 3 Voluson E6 LOGIQ P9/P7 LOGIQ V3 EchoPac

Workstation Vivid 7, Vivid E9,

and Vivid E7 Vivid E80/E90/E95 Vivid i Voluson S6 LOGIQ S6 LOGIQ Book Vivid S60/S70 Vivid in Voluson P8 LOGIQ 5 LOGIQ Book XP Vivid S60N/S70N Vivid e Voluson P6 LOGIQ P6 LOGIC C2/3/5

Vivid T8 and Vivid T8 Pro

Vivid S6 Vivid q Voluson e LOGIQ 3 LOGIQ F Series Vivid-S6 N Vivid q N LOGIQ E10 LOGIQ P3 LOGIQ C9 Series Vivid S5 Voluson 730 LOGIQ E9 LOGIC C3 LOGIQworks

Vivid S5 N Voluson E10 LOGIQ 9 LOGIC C5 LOGIQ V2/V1 Vivid 4 Voluson E8 LOGIQ S8,

Docking and Isolation Carts: Voluson Station/Voluson Dock Cart, LOGIQ e/LOGIQ e Vet/ LOGIQ i/ Vivid e/ Vivid iq / LOGIQbook XP/ LOGIQ e/LOGIQ i/ LOGIQ e Vet/ Vivid e/ Venue

Vivid 3n Voluson S10 LOGIQ S7 LOGIQ i

Vivid P3 Voluson S8 LOGIQ 7 LOGIQ e

Series

Vivid iq Voluson i LOGIQ P5/A5 LOGIQ e Vet

Workstation

LOGIC V5 Venue &

LOGIQ E8

Venue 40/50

1-4 Ultrasound System – Common Service Information

Direction 5444964-100 English

Rev. 5

Chapter 2

Safety Information

This chapter describes important issues related to safely servicing the Ultrasound System. The service provider must read and understand all the information presented here before installing or servicing the Ultrasound System.

Ultrasound System – Common Service Information 2-1 Direction 5444964-100 English Rev. 5

Safety Information

Contents in this chapter

• ‘Important conventions’ on page 2-3

• ‘Product Icons’ on page 2-7

• ‘Safety considerations’ on page 2-8

• ‘Label locations’ on page 2-18

• ‘Dangerous procedure warnings’ on page 2-19

• ‘Lockout/Tagout (LOTO)’ on page 2-20

• ‘Returning probes and repair parts’ on page 2-21

• ‘Electromagnetic compatibility (EMC)’ on page 2-22

Overview

2-2 Ultrasound System – Common Service Information

Direction 5444964-100 English

Rev. 5

Conventions used in book

Important conventions, used in this document, are described below.

Icons

Pictures, or icons, are used wherever they will reinforce the printed message. The icons, labels, and conventions used on the product and in the service information are de scr ib ed in this chapter.

Important conventions

Ultrasound System – Common Service Information 2-3 Direction 5444964-100 English Rev. 5

Safety Information

Important conventions (continued)

Safety precaution messages

Various levels of safety precaution messages may be found on the equipment and in the service information . Th e different levels of concern are identified by a flag word that precedes the precautionary message. Known or potential hazards to personnel are labeled in one of three ways:

• DANGER

• WARNING

• CAUTION

DANGER

WARNING

CAUTION

NOTE: Notes are used to provide important information about an item

NOTE: Be sure to read the notes; the information contained in a note

Danger is used to indicate the presence of a hazard that will cause severe personal injury or death if the instructions are ignored.

Warning is used to indicate the presence of a hazard that can cause severe personal injury and property damage if instructions are ignored.

Caution is used to indicate the presence of a hazard that will or can cause minor personal injury and property damage if instructions are ignored. Equipment damage possible.

or a procedure.

can often save you time or effort.

2-4 Ultrasound System – Common Service Information

Direction 5444964-100 English

Rev. 5

Standard hazard icons

Important information will always be preceded by either the exclamation point (!) contained within a triangle, or the symbols for “Danger”, “Warning” or “Caution” , as see n throughout this chapter and manual. In addition to text, several different graphical icons (symbols) may be used to make you aware of specific types of hazards that could possibly cause harm.

NOTE: Refer to the User Manual for a complete list of icons used on the

Ultrasound System; not all icons may be listed in the table below.

Important conventions

Table 2-1: Common hazard icons

ELECTRICAL

MECHANICAL

RADIATION

LASER

HEAT

PINCH

Ultrasound System – Common Service Information 2-5 Direction 5444964-100 English Rev. 5

Safety Information

Standard Icons that indicate that a special procedure is to be used

Other icons make you aware of specific procedures that should be followed.

Table 2-2: Standard Icons that indicates that a special procedure is to be used

Avoid Static Electricity Tag and Lock Out Wear Eye Protection

Hand Protection Foot Protection Wear Eye Protection

Be sure to read the notes; the information contained in a note can often save you time or effort.

2-6 Ultrasound System – Common Service Information

Direction 5444964-100 English

Rev. 5

Product Icons

Label Icon Description

Refer to the User’s Manual for a description and location of Ultrasound System icons.

How to lock the Operator Panel prior to transport

Refer to the User Manual for the Ultrasound console for instructions.

Product Icons

Ultrasound System – Common Service Information 2-7 Direction 5444964-100 English Rev. 5

Safety Information

Introduction

Human Safety

Safety considerations

The following safety precautions must be observed during all phases of operation, service and repair of this equipment. Failure to comply with these precautions or with specific warnings elsewhere in this manual violates safety standards of design, manufacture, and intended use of the equipment.

• Operating personnel must not remove the Ultrasound system covers.

• Servicing should be performed by authorized personnel only .

Only personnel who have participated in a Ultrasound System Training Seminar are authorized to service the equipment.

NOTE: Local laws may restrict this device for sale or use by or on

the order of a physician.

DANGER DANGEROUS VOL TAGES, CAP ABLE OF CAUSING DEATH, ARE PRESENT

WARNING

IN THIS EQUIPMENT. USE EXTREME CAUTION WHEN HANDLING, TESTING AND ADJUSTING.

If the covers are removed from an operating Ultrasound System, some metal surfaces may be warm enough to pose a potential heat hazard if touched, even while in shutdown mode.

2-8 Ultrasound System – Common Service Information

Direction 5444964-100 English

Rev. 5

Human Safety (continued)

Safety considerations

WARNING

Because of the limited access to cabinets and equipment in the field, placing people in awkward positions, GE has limited the lifting weight for one person in the field to 16 KG (35 LBS). Anything over 16 KG (35 LBS) requires 2 people.

For Console Ultrasound systems and for Ultrasound systems mounted on a Docking/Isolation Cart, have two people available to deliver and unpack the Ultrasound System.

Attempts to move the Ultrasound system considerable distances or on an incline by one person could result in injury or damage or both.

Explosion Warning DO NOT operate the equipment in an explosive atmosphere.

Operation of any electrical equipment in such an environment constitutes a definite safety hazard.

DO NOT substitute parts or modify equipment Because of the danger of introducing additional hazar ds, ONL Y

install GE approved parts. DO NOT perform any unauthorized modification of the equipment.

WARNING

Ultrasound System – Common Service Information 2-9 Direction 5444964-100 English Rev. 5

For Console Ultrasound systems and for Ultrasound systems mounted on a Cart, when the top console is in its locked position, the gas shock is compressed and stores mechanical energy. During normal operation the top console, the weight of the monitor and the mechanical force of the gas shock are in balance. Take care if/when you activate this gas shock. Personal injury can occur after the panel is removed and the shock pressure is released. Take care when you repair the elevation assembly.

Safety Information

Human Safety (continued)

WARNING

Risk of electrical shock, Ultrasound system must be turned off and disconnected from power source. Cord must be controlled at all times.

Wait for at least 30 seconds for capacitors to discharge as there are no test points to verify isolation. The light on the OP panel on/off button will turn off.

Ultrasound System components may be energized. Always refer to the Ultrasound system's Service Manual for LOTO warnings and cautions.

Capacitors on Ultrasound Systems with the Shearwave Option can take up to 5 minutes to discharge.

For Console Ultrasound systems and for Ultrasound systems mounted on a Cart, use extreme caution as long as the Ultrasound System is un-stable, not resting on all four casters.

For Console Ultrasound systems and for Ultrasound systems mounted on a Cart, tilting the console requires two people in order to avoid injury to service personnel and damage to the equipment.

WARNING

Use all Personal Protection Equipment (PPE) such as gloves, safety shoes, safety glasses, and kneeling pads, to reduce the risk of injury.

Beware of possible sharp edges on all mechanical parts. If sharp edges are encountered, the appropriate PPE should be used to reduce the risk of injury.

Wear all PPE including gloves as indicated in the chemical MSDS.

2-10 Ultrasound System – Common Service Information

Direction 5444964-100 English

Rev. 5

Mechanical safety

Safety considerations

WARNING

Ultrasound probes are highly sensitive medical instruments that can easily be damaged by improper handling. Use care when handling and protect from damage when not in use. Do not use a damaged or defective probe. Failure to follow these precautions can result in serious injury and equipment damage.

Never use a probe that has fallen to the floor. Even if it looks OK, it may be damaged.

While the software install procedure is designed to preserve data, you should save any p atient data, ima ges, system setups to removable media or hardcopy before doing a software upgrade.

Ultrasound System – Common Service Information 2-11 Direction 5444964-100 English Rev. 5

Safety Information

Mechanical safety (continued)

CAUTION

Ultrasound System weights can be significant, plus the weight of installed peripherals, when ready for use. Care must be used when moving it or replacing its parts.

Failure to follow the precautions listed below could result in injury, uncontrolled motion and costly damage.

• Use the handle to move the Ultrasound system.

• Be sure the pathway is clear. Limit movement to a slow careful walk.

• Do not let the Ultrasound system strike walls or door frame.

• Use two people when moving on inclines or lifting more than 16 kg (35 lbs).

Use protective glasses during drilling, filing smooth surfaces, and during all other work where eyes need protection.

CAUTION

Use protective gloves when working with sharp edges or when directed to wear PPE during a removal/replacement procedure.

2-12 Ultrasound System – Common Service Information

Direction 5444964-100 English

Rev. 5

Mechanical safety (continued)

Safety considerations

CAUTION

Use safety shoes when doing work where there is any chance of foot injury.

Be careful not to pinch any of the cables.

Ultrasound System – Common Service Information 2-13 Direction 5444964-100 English Rev. 5

Safety Information

Console Ultrasound System

WARNING

Prior to elevating Ultrasound system:

• verify that the floating Operating Panel is locked in its lowest, parking position.

• verify that the front brake is locked and the Ultrasound system is unable to swivel.

• verify that the rear brakes are in the locked position.

When the Ultrasound system is raised for a repair or moved along any incline, use extreme caution since it may become unstable and tip over.

The Ultrasound system should not be moved with the Operator I/O Panel extended. Move the operator i/o panel to it s centered and locked position. Lower the Operator I/O Panel as much as possible before moving the Ultrasound system.

Remember: If the front caster swivel lock is engaged for transportation, pressing the release pedal once disengages the swivel lock. You must depress the release pedal a second time to engage the brake.

NOTE: Refer to the Ultrasound Basic User Manual for the product for

brake and swivel control instructions.

2-14 Ultrasound System – Common Service Information

Direction 5444964-100 English

Rev. 5

Console Ultrasound System (continued)

Safety considerations

CAUTION

Before you move or transport the Ultrasound system, make sure to lock the LCD monitor arm firmly and flip down the monitor to prevent damage to the Ultrasound system.

Always lock the Top Console (Operating Panel) in its parking (locked) position before moving the Ultrasound system around.

To avoid injury when you move the LCD monitor and the monitor arm, do not put your finger, hand, or object on the joint of the monitor or the monitor arm.

Ensure that nobody touches the console arm/frogleg when moving the Operating Panel.

Do not move the Ultrasound system if the Operating Panel is in unlocked position.

CAUTION

Ultrasound System – Common Service Information 2-15 Direction 5444964-100 English Rev. 5

Do not transport Ultrasound System in a vehicle without locking the casters (wheels) and securing it.

Keep the heat venting holes on the monitor unobstructed to avoid overheating of the monitor.

Safety Information

Mechanical safety (continued)

NOTE: Special care should be taken when transporting the Ultrasound

system in a vehicle:

• Before transporting, place the Ultrasound system in its special storage case.

• Ensure that the Ultrasound system is firmly secured while inside the vehicle.

• Secure Ultrasound system with straps or as directed otherwise to prevent motion during transport.

• Prevent vibration damage by driving cautiously. Avoid unpaved roads, excessive speeds, and erratic stops or starts.

Electrical safety

Safe practices

Follow these guidelines to minimize shock hazards whenever you are using the Ultrasound System:

WARNING

• To minimize shock hazard, the equipment chassis must be connected to an electrical ground.

• The Ultrasound System is equipped with a three-conductor AC power cable. This must be plugged into an approved electrical outlet with safety ground.

• The power outlet used for this equipment should not be shared with other types of equipment.

• Both the Ultrasound System power cable and the power connector must meet international electrical standards

Connecting a Ultrasound System to the wrong voltage level will most likely destroy it.

2-16 Ultrasound System – Common Service Information

Direction 5444964-100 English

Rev. 5

Probes

Safety considerations

Follow these guidelines before connecting a probe to the Ultrasound system:

• Inspect the probe prior to each use for damage or degradation to the:

• housing

• cable strain relief

• lens

• seal

• connector pins

• locking mechanism

• Do not use a damaged or defective probe.

• Never immerse the probe connector or adapter into any liquid.

• The Ultrasound System has more than one type of probe port. Use the appropriate probe port designed for the probe you are connecting.

Peripherals

Refer to the Patient Safety Environment section of the User’s Manual for peripheral isolation information.

Ultrasound System – Common Service Information 2-17 Direction 5444964-100 English Rev. 5

Safety Information

Product Labels

Label locations

It is important to refer to the current revision of the Ultrasound System’s User Manual for a full list of product labels prior to servicing the Ultrasound System.

2-18 Ultrasound System – Common Service Information

Direction 5444964-100 English

Rev. 5

Warnings

DANGER DANGEROUS VOL TAGES, CAP ABLE OF CAUSING DEATH, ARE PRESENT

Dangerous procedure warnings

Warnings, such as the example below, precede potentially dangerous procedures throughout this manual. Instructions contained in the warnings must be followed.

IN THIS EQUIPMENT. USE EXTREME CAUTION WHEN HANDLING, TESTING AND ADJUSTING.

WARNING

If the covers are removed from an operating Ultrasound System, some metal surfaces may be warm enough to pose a potential heat hazard if touched, even while in shutdown mode.

Explosion Warning DO NOT operate the equipment in an explosive atmosphere.

Operation of any electrical equipment in such an environment constitutes a definite safety hazard.

DO NOT substitute parts or modify equipment Because of the danger of introducing additional hazar ds, ONL Y

install GE approved parts. DO NOT perform any unauthorized modification of the equipment.

Ultrasound System – Common Service Information 2-19 Direction 5444964-100 English Rev. 5

Safety Information

LOTO Requirements

Follow Lockout/T agout requirements by ensuring you are in total control of the AC power plug at all times during the service process.

To apply Lockout/Tagout (LOTO):

1. Plan and prepare for shutdown.

2. Shutdown the equipment.

3. Isolate the equipment.

4. Remove/disconnect the battery, if present.

5. Apply Lockout/Tagout Devices.

6. Control all stored and residual energy.

7. Verify isolation.

Lockout/Tagout (LOTO)

WARNING

All potentially hazardous stored or residual energy is relieved.

Energy Control and Power Lockout for Ultrasound System. When servicing parts of the Ultrasound system where there is

exposure to voltage greater than 30 volts:

1. Follow LOCK OUT/TAG OUT procedures.

2. Turn off the breaker.

3. Unplug the Ultrasound system from the wall outlet, then from the Ultrasound System.

4. Maintain exclusive control of the Ultrasound system power cable.

5. Wait at least 30 seconds for capacitors to discharge as there are no test points to verify isolation.

6. Remove/disconnect the battery if present.

Ultrasound System components may be energized. Capacitors on Ultrasound Systems with the Shearwave Option

can take up to 5 minutes to discharge.

2-20 Ultrasound System – Common Service Information

Direction 5444964-100 English

Rev. 5

Returning probes and repair parts

Requirements for Returning Parts

Equipment being returned must be clean and free of blood and other infectious substances. GE policy states that body fluids must be properly removed from any part or equipment prior to shipment. GE employees, as well as customers, are responsible for ensuring that parts/equipment have been properly decontaminated prior to shipment. Under no circumstance should a part or equipment with visible body fluids be taken or shipped from a clinic or site (for example, body coils or an ultrasound probe). The purpose of the regulation is to protect employees in the transportation industry, as well as the people who will receive or open this package.

NOTE: The US Department of Transportation (DOT) has ruled that

“items that were saturated and/or dripping with human blood that are now caked with dried blood; or which were used or intended for use in patient care” are “regulated medical waste” for transportation purposes and must be transported as a hazardous material.

NOTE: The USER/SERVICE staff should dispose of all the waste

properly , per federal, st ate, and local waste disposal regulation s.

User Responsibility

The Ultrasound System is not meant to be used for long-term storage of patient data or images. The user is responsible for the data on the Ultrasound System and a regular backup is highly recommended. If the Ultrasound System is sent for repair, please ensure that any patient information is backed up and erased from the Ultrasound System before shipping. It is always possible during system failure and repair to lose patient data. GE is not responsible for the loss of this data. If PHI (Patient Healthcare Information) data needs to be sent to GE employees for service purposes, GE will ascertain agreement from the customer. Patient information shall only be transferred by approved service processes, tools and devices restricting access, protecting or encrypting data where required, and providing traceability in the form of paper or electronic documents at each stage of the procedure while maintaining compliance with cross-border restrictions of patient information transfers.

GE employees: Please refer to DOC1487129, GEHC Global Service Privacy and Security Standards. It is available in MyWorkshop.

Ultrasound System – Common Service Information 2-21 Direction 5444964-100 English Rev. 5

Safety Information

Electromagnetic compatibility (EMC)

What is EMC?

Electromagnetic compatibility describes a level of performance of a device within its electromagnetic environment. This environment consists of the device itself and its surroundings including other equipment, power sources and persons with which the device must interface. Inadequate compatibility results when a susceptible device fails to perform as intended due to interference from its environment or when the device produces unacceptable levels of emission to its environment. This interference is often referred to as radio–frequency or electromagnetic interference (RFI/EMI) and can be radiated through space or conducted over interconnecting power of signal cables. In addition to electromagnetic energy, EMC also includes possible effects fr om electrical fields, magnetic fields, electrostatic discharge and disturbances in the electrical power supply.

Compliance

Ultrasound System conforms to all applicable conducted and radiated emission limits and to immunity from electrostatic discharge, radiated and conducted RF fields, magnetic fields and power line transient requirements.

For applicable standards, refer to the Safety Chapter of the Ultrasound system’s User’s Manual.

NOTE: For CE Compliance, it is critical that all covers, screws,

shielding, gaskets, mesh, clamps, are in good condition, installed tightly without skew or stress. Proper installation following all comments noted in this service manual is required in order to achieve full EMC performance.

2-22 Ultrasound System – Common Service Information

Direction 5444964-100 English

Rev. 5

Electromagnetic compatibility (EMC)

Electrostatic discharge (ESD) prevention

WARNING

DO NOT touch any boards with integrated circuits prior to taking the necessary ESD precautions.

Always connect yourself, via an arm-wrist strap, to the advised ESD connection point located on the rear of the Ultrasound system (near the power connector).

Follow general guidelines for handling of electrostatic sensitive equipment.

Risk of electrical shock, Ultrasound system must be turned off. Avoid all contact with electrical co ntacts, conductors and components. Always use non-conductive handles designed for the removal and replacement of ESD sensitive parts. All parts that have the potential for storing energy must be discharged or isolated before making contact.

If the covers are removed from an operating Ultrasound System, some metal surfaces may be warm enough to pose a potential heat hazard if touched, even while in shutdown mode.

Ultrasound System – Common Service Information 2-23 Direction 5444964-100 English Rev. 5

Safety Information

2-24 Ultrasound System – Common Service Information

Direction 5444964-100 English

Rev. 5

Chapter 3

Site Preparations

This chapter provides the information required to plan and prepare for the setup of an Ultrasound system. Included are descriptions of the facility and electrical needs to be met by the purchaser of the Ultrasound system.

Ultrasound System – Common Service Information 3-1 Direction 5444964-100 English Rev. 5

Site Preparations

Contents in this chapter

• ‘General Ultrasound system requirements’ on page 3-3

• ‘Facility needs’ on page 3-21

Overview

3-2 Ultrasound System – Common Service Information

Direction 5444964-100 English

Rev. 5

General Ultrasound system

Contents in this section

• ‘Ultrasound system environmental requirements’ on

page 3-3

• ‘Electrical requirements’ on page 3-5

• ‘EMI limitations’ on page 3-18

• ‘EMI prevention/abatement’ on page 3-19

• ‘Probes environmental requirements’ on page 3-20

• ‘Time and manpower requirements’ on page 3-20

General Ultrasound system requirements

requirements

Ultrasound system environmental requirements

If the Ultrasound system is very cold or hot

When unpacking the Ultrasound system, allow the temperature of the Ultrasound system to stabilize before powering up. The following table describes guidelines for reaching operational temperatures from storage or transport temperatures.

CAUTION

If the Ultrasound system is very cold or hot, do not turn on its power until it has had a chance to acclimate to its operating environment.

Table 3-1: Ultrasound system acclimate time

Ultrasound System – Common Service Information 3-3 Direction 5444964-100 English Rev. 5

Site Preparations

Environmental specifications for Ultrasound System system

Refer to the User Manual/ Basic User Manual for the product.

Cooling

The cooling requirement for a console Ultrasound system with monitor and on board peripherals, is up to 3800 BTU/h. This figure does not include cooling needed for lights, people, or other equipment in the room.

NOTE: Each person in the room places an additional 300 BTU/h

demand on the cooling system.

Lighting

Bright light is needed for Ultrasound system installation, updates and repairs. However, operator and patient comfort may be optimized if the room light is subdued and indirect. Therefore a combination lighting system (dim/bright) is recommended. Keep in mind that lighting controls and dimmers can be a source of EMI which could degrade image quality. These controls should be selected to minimize possible interference.

3-4 Ultrasound System – Common Service Information

Direction 5444964-100 English

Rev. 5

Electrical requirements

General requirements

NOTE: GE requires a dedicated power and ground for the proper

operation of its Ultrasound equipment. This dedicated power shall originate at the last distribution panel before the Ultrasound system.

The Ultrasound System will function on voltages from 100-240 Volts and 5 0 or 60 Hz. However, if using 220 volt power in North America, then a center tapped power source is required.

General Ultrasound system requirements

Sites with a mains power system with defined Neutral and Live The dedicated line shall consist of one phase, a neutral (not

shared with any other circuit), and a full size ground wire from the distribution panel to the Ultrasound outlet.

Sites with a mains power system without a defined Neutral The dedicated line shall consist of one phase (two lines), not

shared with any other circuit, and a full size ground wire from the distribution panel to the Ultrasound outlet.

NOTE: Please note that image artifacts can occur, if at any time within

the facility, the ground from the main facility's incoming power source to the Ultrasound system is only a conduit.

Electrical requirements for the Ultrasound System

The electrical requirements vary depending on the mains voltage and the equipment in use.

Contents:

• ‘Electrical requirements for Console Ultrasound Systems’ on

page 3-6

• ‘Electrical requirements for Laptop Ultrasound Systems’ on

page 3-11

• ‘Electrical requirements for the Handheld Ultrasound Systems’ on page 3-15

• ‘Electrical requirements for the Ultrasound workstations’ on

page 3-16

Ultrasound System – Common Service Information 3-5 Direction 5444964-100 English Rev. 5

Site Preparations

Electrical requirements for Console Ultrasound Syst ems

Contents:

• ‘Electrical Requirements - Invenia ABUS’ on page 3-6

• ‘Electrical requirements - LOGIQ Consoles’ on page 3-7

• ‘Electrical Specifications for LOGIQ C Series and LOGIQ C3/C5 Premium’ on page 3-8

• ‘Electrical Requirements - Vivid Consoles’ on page 3-9

• ‘Electrical Requirements - Voluson Consoles’ on page 3-10

Table 3-2: Electrical Requirements - Invenia ABUS

Current or Power

Product Voltage Tolerance

Consumption

Frequency

Invenia ABUS Scan Station

100 - 240 VAC ±10% 10 A 50/60 Hz

3-6 Ultrasound System – Common Service Information

Direction 5444964-100 English

Rev. 5

General Ultrasound system requirements

Table 3-3: Electrical requirements - LOGIQ Consoles

Product Voltage Tolerance

Current or

Power

Consumption

Frequency

LOGIQ E10 100-240 VAC LOGIQ E9 100-240 VAC 1100 W (valid

LOGIQ P5 LOGIQ A5

LOGIQ E8 LOGIQ S8 LOGIQ S7

LOGIQ P3 100-120 VAC

LOGIQ P6 100-120 VAC

LOGIQ P9/P7 100-120 VAC

LOGIQ 9 100-120 VAC 9.5 A

LOGIQ 7

100-120 VAC 200-240 VAC

200-240 VAC

200-240 VAC 4.75 A 100 VAC 115 VAC 220 VAC

±10%

0.9kVA

through R5)

1.0kVA (effective from R6)

750 VA

900 VA

425 VA

950 VA

500 VA

MAX. 1200 VA

50/60Hz (±2Hz)

100 VAC

LOGIQ 5

LOGIQ 3

LOGIQ F Series 100-240 VAC LOGIQ C9 Series 220-240 VAC MAX. 950 VA LOGIQ V3/LOGIQ

V5/LOGIQ V5 Expert

115 VAC 230 VAC 100 VAC 115 VAC 230 VAC

100-240 VAC MAX. 300 VA

±10%

MAX. 1250 VA

MAX. 860VA

MAX. 400 VA

50/60Hz (±2Hz)

Ultrasound System – Common Service Information 3-7 Direction 5444964-100 English Rev. 5

Site Preparations

Electrical requirements for Console Ultrasound Systems (continued)

The following power line parameters should be monitored for one week before installation. We recommend that you use an analyzer Dranetz Model 606-3 or Dranetz Model 626:

Table 3-4: Electrical Specifications for LOGIQ C Se ries and LOGIQ C3/C5 Premium

Parameter Area Limits

Voltage Range 100-120V~ 500VA

220-240V~ 500VA Power All applications MAX. 750 VA Line Frequency All applications 50/60Hz (±2Hz) Power Transients All applications Less than 25% of nominal peak

voltage for less than 1 millisecond for any type of transient, including line frequency, synchronous, asynchronous, or aperiodic transients.

Decaying Oscillation All applications Less than 15% of peak voltage

for less than 1 millisecond.

3-8 Ultrasound System – Common Service Information

Direction 5444964-100 English

Rev. 5

General Ultrasound system requirements

Electrical requirements for Console Ultrasound Systems (continued)

Table 3-5: Electrical Requirements - Vi vid Consoles

Current or

Power

Product Voltage Tolerance

Consumption

Frequency

Vivid E7/E9 100-230 VAC Vivid 7 230 VAC 5 A Vivid 7 100-120 VAC 10 A Vivid S5/S5N

Vivid S6/S6N

Vivid 4

Vivid 3

Vivid P3 100-120 VAC

Vivid E95 Vivid E90 Vivid E80

Vivid S60/S70/ S60N/S70N

Vivid T8/Vivid T8 Pro

100-240 VAC 0.5 to 1A

±10%

100 VAC 8 A 120 VAC 8 A 220-240 VAC 4 A 100 VAC 8 A 120 VAC 8 A 230 VAC 4 A

220-240 VAC

100-240 VAC 700 W / 770 VA

100-240 VAC 500VA

100-240 VAC 400VA

1100 W

425 VA

50/60 Hz

Vivid iq 100-240 VAC Max. 150VA

Ultrasound System – Common Service Information 3-9 Direction 5444964-100 English Rev. 5

Site Preparations

Electrical requirements for Console Ultrasound Systems (continued)

Table 3-6: Electrical Requirements - Voluson Consoles

Current or

Power

Product Voltage Tolerance

Consumption

Frequency

100 VAC 110 VAC 9.2 A

Voluson® 730

Voluson E6 / Voluson E8 model-type <=BT13

Voluson E6 / Voluson E8 model-type >BT13 Voluson E10, >BT15

Voluson P6 / Voluson P8 100-240 VAC 900 VA

Voluson S6 / Voluson S8

Voluson S10 100-120 VAC

115 VAC 8.8 A 130 VAC 7.8 A 230 VAC 4.4 A 240 VAC 4.2 A 100 - 130 VAC 10.3 - 7.7 A 220 - 240 VAC 4.5 - 4.2 A

100-240 VAC 800 VA

100-130 VAC 200-240 VAC 900 VA

220-240 VAC 900 VA

±10%

10.1 A

50, 60 Hz (±2Hz)

3-10 Ultrasound System – Common Service Information

Direction 5444964-100 English

Rev. 5

General Ultrasound system requirements

Electrical requirements for Laptop Ultrasound Systems

Contents:

• ‘Electrical Requirements - LOGIQ Laptops’ on page 3-11

• ‘Electrical Requirements - Vivid Laptops’ on page 3-12

• ‘Electrical Requirements - Voluson Laptops’ on page 3-12

• ‘Docking Cart for LOGIQ e/LOGIQ e Vet/LOGIQ i/Vivid| e/ Vivid iq Power Requirements’ on page 3-13

• ‘Isolation Cart for LOGIQBook XP Series/LOGIQ e/ LOGIQ e Vet/LOGIQ i/Vivid e’ on page 3-14

Table 3-7: Electrical Requirements - LOGIQ Laptops

Product Voltage Tolerance

Current or

Power

Consumption

Frequency

LBAC-66 adapter for LOGIQ Book

GE-90W adapter for LOGIQ Book

ADM-9020M-GE for LOGIQ Book XP Series

Adapter for LOGIQ e and LOGIQ e Vet R7.x.x and below.

Adapter for LOGIQ i Adapter for LOGIQ e

R8.x.x, R9.x.x AC Adapter for LOGIQ

V2/V1

100-240 VAC ±10%

120 VA 1.2-0.5 A

50-60 Hz

108 VA 1.08-0.45 A

130 VA max. 1.3 A (max.) 50/60 Hz

160 VA max. 1.6 A (max.)

2 A 50-60 Hz

Ultrasound System – Common Service Information 3-11 Direction 5444964-100 English Rev. 5

Site Preparations

Electrical requirements for Laptop Ultrasound Systems (continued)

Table 3-8: Electrical Requirements - Vivid Laptops

Current or

Power

Product Voltage Tolerance

AC/DC Converter for Vivid i/Vivid iN and Vivid q/ Vivid qN

100 - 240 VAC ±10% 0.5 to 1.0 A 50-60 Hz

Consumption

Frequency

Adapter for Vivid e 100 - 240 VAC ±10% 130 VA max. 1.3 A

(max.)

Table 3-9: Electrical Requirements - Voluson Laptops

Current or

Power

Product Voltage Tolerance

Voluson i/e 100 - 240 VAC Voluson Station /

Voluson Dock Cart

100-130 VAC 220-240 VAC 320 VA

±10%

Consumption Frequency

120 VA

50/60 Hz

50, 60 Hz (±2%)

3-12 Ultrasound System – Common Service Information

Direction 5444964-100 English

Rev. 5

General Ultrasound system requirements

Electrical Requirements for Docking Carts

Table 3-10: Docking Cart for LOGIQ e/LOGIQ e Vet/LOGIQ i/Vivid| e/Vivid iq Power

Requirements

PARAMETER AREA LIMITS FREQUENCY

Voltage Range (Docking Cart used for LOGIQ e/ LOGIQ e Vet R7.x.x and below, LOGIQ i and Vivid e)

100-120V~ 220-240V~

500VA 500VA

Voltage Range (Docking Cart used for LOGIQ e R8.x.x or higher)

Vivid iq Docking Cart 100-240V~ 190VA ~ 350 VA Power All applications More than or equal to 750

Line Frequency All applications 50/60Hz (±2Hz) Power Transients All applications Less than 25% of

Decaying Oscillation All applications Less than 15% of peak

100-240V~ 350 VA

nominal peak voltage for less than 1 millisecond for any type of transient, including line frequency, synchronous, asynchronous, or aperiodic transients.

voltage for less than 1 millisecond.

50/60 Hz

Ultrasound System – Common Service Information 3-13 Direction 5444964-100 English Rev. 5

Site Preparations

Electrical Requirements for Isolation Cart

Table 3-11: Isolation Cart for LOGIQBook XP Series/LOGIQ e/LOGIQ e Vet/LOGIQ i/

Vivid e

Input Output

100-120V~, 50/60Hz, 500VA 100-120V~, 50/60Hz, 250VA 220-240V~, 50/60Hz, 500VA 220--240V~, 50/60Hz, 250VA

Table 3-12: E-Isolation Cart for LOGIQ e

Input Output

100-120V~, 60Hz, 400VA 100-120V~, 60Hz, 350VA 220-240V~, 50Hz, 400VA 220--240V~, 50Hz, 350VA

Table 3-13: Advanced Isolation Cart

Input Output

100-120V~, 60Hz, 400VA 100-120V~, 60Hz, 350VA 220-240V~, 50Hz, 400VA 220--240V~, 50Hz, 350VA

3-14 Ultrasound System – Common Service Information

Direction 5444964-100 English

Rev. 5

General Ultrasound system requirements

Electrical requirements for the Handheld Ultrasound Systems

Contents:

• ‘Electrical Requirements - Venue Series’ on page 3-15

Table 3-14: Electrical Requirem ents - Venue S e rie s

Current or

Power

Product Voltage Tolerance

Consumption Frequency

Venue Venue 40/50 180 VA max. Docking Station

for the Venue Series

Docking Cart for the Venue Series

100-240 VAC ±10%

500 VA

180 VA max.

380 VA max

50 / 60 Hz

Ultrasound System – Common Service Information 3-15 Direction 5444964-100 English Rev. 5

Site Preparations

Electrical requirements for the Ultrasound workstations

Contents:

• ‘Electrical Requirements - EchoPAC PC Turnkey Workstations’ on page 3-16

• ‘Electrical Requirements - LOGIQworks Workstations’ on

page 3-16

Table 3-15: Electrical Requirements - EchoPAC PC Turnkey Workstations

Current or

Power

Product Voltage Tolerance

Consumption Frequency

All models

100 VAC 110 VAC 8 A 230 VAC 4 A

±10%

8 A

Table 3-16: Electrical Requirements - LOGIQworks Workstations

Current or

Power

Product Voltage Tolerance

All models 110 - 230 VAC ±10% 310 to 543 W

Consumption Frequency

(depending on workstation model)

50-60 Hz

3-16 Ultrasound System – Common Service Information

Direction 5444964-100 English

Rev. 5

Site circuit breaker

General Ultrasound system requirements

CAUTION

Site power outlets

Power cable

Power outage may occur. The Ultrasound System requires a dedicated single branch circuit. To avoid circuit overload and possible loss of critical care equipment, make sure you do not have any other equipment operating on the same circuit.

It is recommended that the branch circuit breaker for the Ultrasound system be readily accessible.

A dedicated AC power outlet must be within reach of the Ultrasound system without extension cords. Other outlets adequate for the external peripherals, medical and test equipment needed to support this Ultrasound system must also be present within 1 m (3.2 ft.) of the Ultrasound system. Electrical installation must meet all current local, state, and national electrical codes.

If the Ultrasound system arrives without a power cable, or with the wrong cable, you must contact your GE dealer or the installation engineer must supply what is locally required.

Ultrasound System – Common Service Information 3-17 Direction 5444964-100 English Rev. 5

Site Preparations

EMI limitations

Ultrasound systems are susceptible to Electromagnetic Interference (EMI) from radio frequencies, magnetic fields, and transients in the air or wiring. They also generate EMI. The Ultrasound system complies with limits as stated on the EMC label. However, there is no guarantee that interference will not occur in an installation.

Possible EMI sources should be identified before the Ultrasound system is installed.

Electrical and electronic equipment may produce EMI unintentionally as the result of a defect. Some of these sources include:

• medical lasers

• scanners

• cauterizing guns

• computers

• monitors

• fans

• gel warmers

• microwave ovens

• light dimmers

• mobile phones

• in-house wireless phones (DECT phones)

• wireless computer keyboard and mouse

• air conditioning system

• High Frequency (HF) surgery equipment

• general AC/DC adapters

The presence of a broadcast station or broadcast van may also cause interference.

See: ‘EMI prevention/abatement’ on page 3-19 for EMI prevention tips.

3-18 Ultrasound System – Common Service Information

Direction 5444964-100 English

Rev. 5

EMI prevention/abatement

Prevention/abatement details are provided below:

Table 3-17: EMI prevention/abatement

EMI RULE DETAILS

General Ultrasound system requirements

Be aware of Radio Frequency sources

Ground the Ultrasound system

Replace all screws, Radio Frequency gaskets, covers, cores

Replace broken Radio Frequency gaskets

Do not place labels where Radio Frequency gaskets touch metal

Use GE specified harnesses and peripherals

Take care with cellular phones

Properly route peripheral cables

• Keep the Ultrasound system at least 5 meters (15 feet) away from other EMI sources.

• Special shielding may be required to eliminate interference problems caused by high frequency, high powered radio or video broadcast signals.

Poor grounding is the most likely reason an Ultrasound system will have noisy images. Check grounding of the power cord and power outlet.

• After you finish repairing or updating the Ultrasound system, replace all covers and tighten all screws.

• Any cable with an external connection requires a magnet wrap at each end.

• Install all covers. Loose or missing covers or Radio Frequency gaskets allow radio frequencies to interfere with the ultrasound signals.

If more than 20% or a pair of the fingers on a Radio Frequency gasket are broken, replace the gasket. Do not turn on the Ultrasound system until any loose metallic part is removed.

Where applicable, never place a label where Radio Frequency gaskets meet the Ultrasound system. Otherwise, the gap created will permit Radio Frequency leakage. Or, if a label has been found in such a position, move the label.

The interconnect cables are grounded and require ferrite beads and other shielding. Also, cable length, material, and routing are all important; do not change from what is specified.

Cellular phones may transmit a 5 V/m signal; that could cause image artifacts.

Where applicable, do not allow cables to lie across the top of the Card Rack or hang out of the peripheral bays. Loop the excess length for peripheral cables inside the peripheral bays. Attach the monitor cables to the frame.

Ultrasound System – Common Service Information 3-19 Direction 5444964-100 English Rev. 5

Site Preparations

Probes environmental requirements

Operation and storage temperatures for probes

For probe operation and storage temperature infor mation, refer the the Ultrasound System or Probe User Manual.

Time and manpower requirements

Site preparation takes time. Begin site preparation checks as soon as possible, if possible, six weeks before delivery, to allow enough time to make any changes.

WARNING

For Console Ultrasound systems and for Ultrasound systems mounted on a Docking/Isolation Cart, have two people available to deliver and unpack the Ultrasound System.

Attempts to move the Ultrasound system considerable distances or on an incline by one person could result in injury or damage or both.

3-20 Ultrasound System – Common Service Information

Direction 5444964-100 English

Rev. 5

Contents in this section

• ‘Purchaser responsibilities’ on page 3-21

• ‘Required facility needs’ on page 3-23

• ‘Desirable features’ on page 3-25

Purchaser responsibilities

The work and materials needed to prepare the site is the responsibility of the purchaser. Delay, confusion, and waste of manpower can be avoided by completing pre-installation work before delivery. Purchaser responsibility includes:

• Procuring the materials required

• Completing the preparations before delivery of the Ultrasound system

• Paying the costs for any alterations and modifications not specifically provided in the sales contract

Facility needs

Ultrasound System – Common Service Information 3-21 Direction 5444964-100 English Rev. 5

Site Preparations

Purchaser responsibilities (continued)

NOTE: All electrical installations that are preliminary to the positioning

of the equipment at the site prepared for the equipment must be performed by licensed electrical contractors. Other connections between pieces of electrical equipment, calibrations, and testing must also be performed by qualified personnel. The products involved (and the accompanying electrical installations) are highly sophisticated and special engineering competence is required. All electrical work on these products must comply with the requirements of applicable electrical codes. The purchaser of GE equipment must only utilize qualified personnel to perform electrical servicing on the equipment.

The desire to use a non–listed or customer provided product or to place an approved product further from the Ultrasound system than the interface kit allows, presents challenges to the installation team. To avoid delays during installation, such variances should be made known to the individuals or group performing the installation at the earliest possible date (preferably prior to the purchase).

The ultrasound suite must be clean prior to delivery of the Ultrasound system. Carpet is not recommended because it collects dust and creates static. Potential sources of EMI (electromagnetic interference) shou ld als o be inve stig at ed before delivery. Dirt, static, and EMI can negatively impact Ultrasound system reliability.

3-22 Ultrasound System – Common Service Information

Direction 5444964-100 English

Rev. 5

Required facility needs

NOTE: GE requires a dedicated power and ground for the proper

operation of its Ultrasound equipment. This dedicated power shall originate at the last distribution panel before the Ultrasound system.

The Ultrasound system will function on voltages from 100-240 Volts and 50 or 60 Hz. However, if using 220-volt power in North America, then a center tapped power source is required.

Facility needs

Sites with a mains power system with defined Neutral and Live

The dedicated line shall consist of one phase, a neutral (not shared with any other circuit), and a full-size grou n d wire from the distribution panel to the Ultrasound outlet.

Sites with a mains power system without a defined Neutral

The dedicated line shall consist of one phase (two lines), not shared with any other circuit, and a full-size ground wire from the distribution panel to the Ultrasound outlet.

Scale: Each square equals one square

foot (app. 31 x 31 cm)

1. Door – at least 762 mm (30 inches)

2. Film Viewer

3. Counter Top, Sink with hot and cold water and Supplies Storage

4. Linen Supply

5. Probes/Supplies

6. Examination Table – 1930 x 610 mm (76 x 24 inches)

7. Footswitch

8. Stool

9. Ultrasound system

10. External Peripherals

11. Dedicated Power Outlet Circuit Breaker protected and easily accessible

12. Network Interface

13. 457 mm (18 inches) distance of Ultrasound system from wall or objects

14. GE Cabinet for Software and Manuals

Figure 3-1. Minimal floor plan, 2.5 m x 3 m (8 by 10 foot)

Ultrasound System – Common Service Information 3-23 Direction 5444964-100 English Rev. 5

Site Preparations

Required facility needs (continued)

13 14

Scale: Each square equal one square foot (app. 31 x 31 cm)

1. Secretaries or Doctors Desk

2. File Cabinet

3. Film Viewer

4. Counter Top

5. Counter Top and Sink with hot and cold water

6. Overhead Lights Dimmer Dual Level Lighting (bright and dim)

7. Emergency Oxygen

8. Suction Line

9. Ultrasound system

10. Dedicated Power Outlet Circuit Breaker protected and easily accessible

11. Network Interface

12. 457 mm (18 inches) distance of Ultrasound system from wall or objects

13. Stool

14. Footswitch

15. Storage for Linens and Equipment

16. Examination Table – 1930 x 610 mm (76 x 24 inches)

17. Lavatory and Dressing Room

18. Door – at least 762 mm (30 inches)

Figure 3-2. Recommended floor plan, 4.27 x 5.18 m (14 x 17 foot)

3-24 Ultrasound System – Common Service Information

Direction 5444964-100 English

Rev. 5

Required facility needs (continued)

• Dedicated single branch power outlet of adequate amperage, meeting all local and national codes, which is located less than 2.5 m (8 ft.) from the Ultrasound system’s proposed location

• Door opening is at least 76 cm (30 in) wide

• Proposed location for Ultrasound system is at least 0.5 m (1.5 ft.) from the wall for cooling

• Power outlet and place for any external peripheral are within 2 m (6.5 ft.) of each other with peripheral within 1 m of the Ultrasound system to connect cables.

• Power outlets for other medical equipment

• Power outlets for test equipment within 1 m (3.2 ft.) of Ultrasound system

• Clean and protected space to store probes (in their cases or on a rack)

• Material to safely clean probes (done with a plastic container, never metal)

For the amperage requirements, see: ‘Electrica l requirements’ on page 3-5.

Facility needs

Desirable features

• Door is at least 92 cm (3 ft.) wide

• Circuit breaker for dedicated power outlet is easily accessible

• Sink with hot and cold water

• Receptacle for bio–hazardous waste, like used probe sheaths

• Emergency oxygen supply

• Storage for linens and equipment

• Nearby waiting room, lavatory, and dressing room

• Dual level lighting (bright and dim)

• Lockable cabinet ordered by GE for its software and proprietary manuals

Ultrasound System – Common Service Information 3-25 Direction 5444964-100 English Rev. 5

Site Preparations

3-26 Ultrasound System – Common Service Information

Direction 5444964-100 English

Rev. 5

Chapter 4

Care and Maintenance

This chapter describes Care and Maintenance on the Ultrasound system and peripherals. These procedures are intended to maintain the quality of the Ultrasound system’s performance. Read this chapter completely and familiarize yourself with the procedures before performing a task.

Ultrasound System – Common Service Information 4-1 Direction 5444964-100 English Rev. 5

Care and Maintenance

Normal Care and Maintenance is mandatory; it is the responsibility of the customer and includes the following:

• Quality Assurance Program to perform routine quality control testing.

NOTE: Some customers’ Quality Assurance Programs may require

additional tasks and or inspections at a different frequency than listed in this manual.

• System Maintenance and Checks (Preliminary System, Functional Checks, Peripheral, Cable, Physical Inspection).

• Probe Maintenance

• System Cleaning, including Air Filter Cleaning

• Electrical Safety Testing

Overview

NOTE: It has been determined by engineering that your Ultrasound

System DOES NOT have any high wear components that fail with use. Therefore, Periodic Maintenance inspections are not mandatory for any Ultrasound s ystem. Only normal Care and Maintenance is recommended.

Contents in this chapter

• ‘Warnings’ on page 4-3

• ‘Why do maintenance’ on page 4-4

• ‘Maintenance task schedule’ on page 4-5

• ‘System maintenance’ on page 4-6

• ‘Using a Phantom’ on page 4-13

• ‘Electrical safety tests’ on page 4-14

• ‘When there's too much leakage current …’ on page 4-44

• ‘Ultrasound Equipment Quality Check (EQC and IQC)’ on

page 4-46

4-2 Ultrasound System – Common Service Information

Direction 5444964-100 English

Rev. 5

Warnings

DANGER

CAUTION

WHERE APPLICABLE, THERE ARE SEVERAL PLACES ON THE BACKPLANE, THE AC DISTRIBUTION, AND DC DISTRIBUTION THAT ARE DANGEROUS. BE SURE TO DISCONNECT THE ULTRASOUND SYSTEM POWER PLUG AND OPEN THE MAIN CIRCUIT BREAKER BEFORE YOU REMOVE ANY PARTS. BE CAUTIOUS WHENEVER POWER IS STILL ON AND COVERS ARE REMOVED.

Practice good ESD prevention. Wear an anti–static strap when handling electronic parts and even when disconnecting/ connecting cables.

Do not pull out or insert circuit boards while power is on.

Do not operate this Ultrasound system unless all boar d co ve rs and frame panels are securely in place. System performa nc e and cooling require this.

CAUTION

Ultrasound System – Common Service Information 4-3 Direction 5444964-100 English Rev. 5

To ensure the mutual protection and safety of GE service personnel and our customers, all equipment and work areas must be clean and free of any hazardous contaminants before a Service Engineer starts a repair. This inclu des, but is not limited to, decontamination and/or sterilization, depending on the application or use of the medical device.

Care and Maintenance

Keeping records

It is good business practice that ultrasound facilities maintain records of all corrective maintenance and care and maintenance on Ultrasound systems where it is applicable. The Ultrasound Equipment Quality Check form provides the customer with documentation that the Ultrasound system is maintained regularly.

A copy of the Ultrasound Equipment Quality Check form should be kept in the same room or near the Ultrasound system.

Quality assurance

Why do maintenance

In order to gain accreditation from organizations such as the American College of Radiology (USA), it is the customer’s responsibility to have a quality assurance program in place for each Ultrasound system. The program must be directed by a medical physicists, the supervising radiologist/physician or appropriate designee.

Routine quality control testing must occur regularly. The same tests are performed during each period so that changes can be monitored over time and effective corrective action can be taken.

Testing results, corrective action and the effects of corrective action must be documented and maintained on the site.

Your GE service representative can help you with establishing, performing and maintaining records for a qua lity assurance program. Contact GE for coverage and/or price for service.

4-4 Ultrasound System – Common Service Information

Direction 5444964-100 English

Rev. 5

Maintenance task schedule

How often should maintenance tasks be performed?

The Customer Care Schedule specifies how often your Ultrasound System should be serviced and outlines items requiring special attention.

NOTE: It is the customer’s responsibility to ensure the Ultrasound

System care and maintenance is performed as scheduled in order to retain its high level of safety, dependability and performance.

Your GE Service Representative has an in-depth knowledge of your Ultrasound System and can best prov ide com p et en t, efficient service. Contact GE for coverage inform ation and/or price for service.

The service procedures and recommended intervals shown in the Customer Care Schedule assumes that you use your Ultrasound System for an average patient load (10-12 per day) and not use it as a primary mobile Ultrasound system which is transported between diagnostic facilities.

NOTE: If conditions exist which exceed typical usage and patient load,

then it is recommended to increase the maintenance frequencies.

Please refer to the Customer Care Schedule in the service manual for the Ultrasound System unit for the correct maintenance care schedule.

Ultrasound System – Common Service Information 4-5 Direction 5444964-100 English Rev. 5

Care and Maintenance

System maintenance

Preliminary checks

The preliminary checks take about 15 minutes to perform. Refer to the Ultrasound system user documentation whenever necessary.

Table 4-1: Ultrasound system preliminary checks

Step Item Description

1. Ask and Listen Ask the customer if they have any problems or questions about the equipment.

2. Paperwork Fill in the top of the EQC inspection form. Record all probes and

3. Power up • Turn the Ultrasound system power on and verify that all fans and

4. Probes Verify that the Ultrasound system properly recognizes all probes.

5. Displays Verify proper display on the monitor and touch panel (where present).

6. InSite Where applicable, for Warranty and Contract Customers only:

7. Review Error Logs Where applicable, Error Logs can be reviewed via system diagnostics.

8. Diagnostics Optional.

9. Presets Backup all Customer Presets to an appropriate media.

10. Image Archive Back up the Image Archive onto appropriate media.

Ultrasound system options.

peripherals turn on.

• Watch the displays during power up to verify that no warning or error

messages are displayed.

• Where applicable, confirm that the battery is charged. If no AC Input

present, use the internal battery.

• Verify that InSite is functioning properly.

• Ensure two-way remote communications.

4-6 Ultrasound System – Common Service Information

Direction 5444964-100 English

Rev. 5

System maintenance

Functional checks

The functional checks take about 60 minutes to perform. Refer to the Ultrasound system user documentation whenever necessary.

System checks

Table 4-2: Ultrasound system functional checks

Step Item Description

1. B-Mode Verify basic B-Mode (2D) operation. Check the basic Ultrasound system

controls that affect this mode of operation.

2. CF-Mode Verify basic CF-Mode (Color Flow Mode) operation. Check the basic

Ultrasound system controls that affect this mode of operation.

3. Doppler Modes Where applicable, verify basic Doppler operation (PW and CW if

4. M-Mode Verify basic M-Mode operation. Check the basic Ultrasound system

5. 3D Mode Where applicable, verify basic 3D Mode operation.

6. RealTime 4D

Mode

7. Basic

Measurements

8. Probe Elements Perform an Element Test on each probe to verify that all the probe

9. Applicable

Software Options

10. System Diagnostic Perform the Automatic Tests, where applicable.

11. Transmit/Receive Verify that all system XMIT/RECV channels are functional, where

12. Operating Panel

test

available). Check the basic Ultrasound system controls that affect this mode of operation.

controls that affect this mode of operation.

Check the basic system controls that affect this mode of operation. Where applicable, verify basic RealTime 4D Mode operation.

Check the basic system controls that affect this mode of operation. Check Distance and Tissue Depth Measurement.

elements and Ultrasound system channels are functional, where applicable.

Verify the basic operation of all optional modes. Check the basic system controls that affect each options operation.

applicable. Perform the Operating Panel Test Procedure.

13. Keyboard Do the interactive keyboard test.

14. Touch Panel Where applicable, verify basic Touch Panel display functions.

15. Monitor Verify basic monitor display functions.

16. Peripherals See: ‘Peripheral/option checks’ on page 4-8.

Ultrasound System – Common Service Information 4-7 Direction 5444964-100 English Rev. 5

Care and Maintenance

Peripheral/option checks

If any peripherals or options are not part of the Ultrasound system configuration, the check can be omitted.

Table 4-3: GE approved peripheral/hardware option functional checks

Step Item Description

1. Media Verify media drive(s) read/write properly. Clean if necessary.

2. B/W Printer Verify hardcopy output of the B/W video page printer. Clean heads and

3. Color Printer Verify hardcopy output of the Color video page printer. Clean heads and

4. DICOM Verify that DICOM is functioning properly. Send an image to a DICOM

5. ECG Verify basic operation with customer

6. Footswitch V erify that the footswitch is functioning as programed. Clean as necessary.

covers if necessary.

device.

Mains cable inspection

Table 4-4: Mains Cable Inspection, As Appropriate

Step Item Description

1. Unplug Cord Disconnect the mains cable from the wall and Ultrasound system.

2. Inspect Inspect it and its connectors for damage of any kinds.

3. Verify Verify that the LINE, NEUTRAL and GROUND wires are properly attached

to the terminals, and that no strands may cause a short circuit.

4. Verify Inlet connector retainer is functional.

4-8 Ultrasound System – Common Service Information

Direction 5444964-100 English

Rev. 5

Optional diagnostic checks

To complete the Ultrasound System checks, view the error logs and run desired diagnostics.

View the logs

1. Review the Ultrasound system error log for any problems.

2. Check the temperature log to see if there are any trends that could cause problems in the future.

Physical inspection

NOTE: These features may not be present on all Ultrasound systems.

Table 4-5: Physical checks

Step Item Description

System maintenance

1. Labeling Verify that all Ultrasound system labeling is present and in readable

2. Scratches & Dents Inspect the exterior for dents, scratches or cracks.

3. Covers Where applicable, verify all covers are secured in place and are properly

4. Operating Panel Inspect alphanumeric keyboard and operator panel (operator control

5. Operating Panel Movement

6. Operating Panel Lights

7. LCD Inspect the LCD Display for scratches and bad pixels.

8. Monitor Light Check for proper operation of any monitor lights, if available.

9. Input Power Refer to: ‘Mains cable inspection’ on page 4-8.

condition.

aligned with other covers. Replace any covers that are damaged.

panel). Record any damaged or missing items.

• Where applicable, verify ease of operating panel (operator control panel) movement in all acceptable directions.

• Where applicable, ensure that it latches in position as required.

Check for proper operation of all operating panel and TGC lights.

Verify proper operation of Contrast and Brightness controls. Where applicable, confirm that the LCD arm allows:

• swivelling the screen to the left and to the right

• folding the screen to the locked position

• release and adjustment backwards and forwards

• can be adjusted in the up/down positions.

Note: LCD Arm movement may vary and is not applicable to all Ultrasound systems.

10. External I/O Check all connectors for damage and verify that the labeling is good.

Ultrasound System – Common Service Information 4-9 Direction 5444964-100 English Rev. 5

Care and Maintenance

Table 4-5: Physical checks (Continued)

Step Item Description

11. Wheels and Brakes

12. Cables and Connectors

13. Shielding and Covers

14. Control Panel Inspect alphanumeric keyboard and Operating Panel. Record any

15. Probe Holders Where applicable, inspect the Probe Holders for cracks or damage.

16. Power and System Status Indicators

17. Battery Where applicable, check that the battery is not damaged, does not leak,

18. External Microphone

• Where applicable, check all wheels and casters for wear and verify operation of foot brake, to stop the Ultrasound system from moving, and release mechanism.

• Where applicable, check all wheel locks and wheel swivel locks for proper operation.

Check all internal cable harnesses and connectors for wear and secure connector seating. Pay special attention to footswitch assembly and probe strain or bend reliefs.

Check to ensure that all EMI shielding, internal covers, air flow panels and screws are in place. Missing covers and hardware could cause EMI/RFI problems while scanning.

damaged or missing items.

Check for proper operation of all Power and System Status Indicators.

does not emit an odor, and is not deformed or discolored. Observe all warnings and cautions for battery handling, recharging, storing, and/or disposal,

Where applicable, check for proper operation of any external microphones by recording an audio test.

4-10 Ultrasound System – Common Service Information

Direction 5444964-100 English

Rev. 5

Cleaning

Air filter cleaning

System maintenance

Refer to the User Manual for the Ultrasound console for instructions.

Ultrasound System – Common Service Information 4-11 Direction 5444964-100 English Rev. 5

Care and Maintenance

Probe maintenance

Refer to the Ultrasound System User Manual, the probe’s User Manual/Probe Care Card, or Probe Addendum (p/n 5661328) for probe maintenance, checks, cleaning, and disinfecting instructions.

WARNING

CAUTION

To help protect yourself from blood bo rne diseases, wear approved disposable gloves. These are made of nitrile derived from vegetable starch to prevent allergic latex reactions.

Failure to follow the prescribed cleaning or disinfection procedures will void the probe’s warranty.

DO NOT soak or wipe the lens with any product not listed in the User Manual. Doing so could result in irreparable damage to the probe.

Follow care instructions that came with the probe.

Disinfect a defective probe before you return it. Be sure to tag the probe as being disinfected.

Transesophageal and intraoperative probes require a special handling. Refer to the user document ation enclose d with these probes.

NOTE: GE does not substantiate the effectiveness of recommended

disinfectant products. Questions regarding efficacy, instructions for use, and proper handling should be direct ed to the disinfectant manufacturer. GE publishes a list of material-compatible disinfectants (see below and also refer to the GE website at http://www3.gehealthcare.com/en/Products/ Categories/Ultrasound/Ultrasound_Probes. DO NOT use non-GE-approved disinfectant s or products that have not been evaluated by GE for material compatibility. Damages linked to the use of disapproved chemicals are not covere d under product warranty or service contract.)

4-12 Ultrasound System – Common Service Information

Direction 5444964-100 English

Rev. 5

Phantoms

Using a Phantom

The use of a Phantom is not required during Care and Maintenance, except for the Invenia ABUS Scan Station. Customer may use it as part of their Quality Assurance Prog ram tests.

Ultrasound System – Common Service Information 4-13 Direction 5444964-100 English Rev. 5

Care and Maintenance

Content in this section

The following topics and measurements are covered in this section:

• ‘Uninterrupted Power Supply (UPS)’ on page 4-15

• ‘Safety test overview’ on page 4-16

• ‘Leakage current limits’ on page 4-19

• ‘Outlet test - wiring arrangement - USA and Canada’ on

• ‘Grounding continuity’ on page 4-24

• ‘Chassis leakage current test’ on page 4-25

• ‘Isolated patient lead (source) leakage–lead to ground’ on

• ‘Isolated patient lead (source) leakage–lead to lead’ on

• ‘Isolated patient lead (sink) leakage-isolation test’ on

• ‘Probe (Source) leakage current test’ on page 4-35

• ‘Isolated Probe (Sink) Leakage-Isolation Test’ on page 4-40

Electrical safety tests

page 4-23

page 4-29

page 4-31

page 4-33

4-14 Ultrasound System – Common Service Information

Direction 5444964-100 English

Rev. 5

Uninterrupted Power Supply (UPS)

NOTE: For all instructions in the “Electrical safety tests” section in case

of using a UPS (uninterrupted power supply) the terms outlet, wall outlet, AC wall outlet and power outlet refer to the AC power outlet of the UPS. In case of further available AC (or DC) power outlets at the same used UPS, these must remain unused i.e. not connected to any other devices.

Electrical safety tests

CAUTION

Please observe that some Uninterruptible Power Supplies (UPS) may not be medical devices! If the UPS is not a medical device, it has to be located outside of the patient environment (according to IEC 60601-1 / UL 60601-1).

2.5 m

1.5 m 1.5 m

1. Patient environment

Ultrasound System – Common Service Information 4-15 Direction 5444964-100 English Rev. 5

Care and Maintenance

Safety test overview

WARNING

CAUTION

Energy Control and Power Lockout for Ultrasound System. When servicing parts of the Ultrasound system where there is

exposure to voltage greater than 30 volts:

1. Follow LOCK OUT/TAG OUT procedures.

2. Turn off the breaker.

3. Unplug the Ultrasound system from the wall outlet, then from the Ultrasound System.

4. Maintain exclusive control of the Ultrasound system power cable.

5. Wait at least 30 seconds for capacitors to discharge as there are no test points to verify isolation.

6. Remove/disconnect the battery if present.

Ultrasound System components may be energized. Capacitors on Ultrasound Systems with the Shearwave Option

can take up to 5 minutes to discharge.

Possible risk of infection. Do not handle soiled or contaminated probes and other

components that have been in patient contact. Follow appropriate cleaning and disinfecting procedures before handling the equipment.

The electrical safety tests in this section are based on IEC60601 standard including national deviations for Health Care Facilities and IEC 62353 Medical electrical equipment – Recurrent test and test after repair of medical electrical equipment. These standards provide guidance on evaluating electrical safety of medical devices which are placed into service and are intended for use in normal Care and Maintenance or testing following service or repair activities. They differ somewhat from the standards that are used for design verification and manufacturing tests (e.g., IEC 60601-1 including national deviations) which require a controlled test environment and can place unnecessary stress on the Ultrasound system.

These tests may refer to specific safety analyzer equipment as an example. Always refer to the safety analyzer’s user manual that will be used to perform the tests.

4-16 Ultrasound System – Common Service Information

Direction 5444964-100 English

Rev. 5

Safety test overview (continued)

Prior to initiating any electrical test, the Ultrasound system must be visually inspected. Perform the following visual checks:

• Check for missing or loose enclosure covers that could allow access to internal live parts.

• Examine the mains cord, mains plug and appliance inlet for damaged insulation and adequacy of strain relief and cable clamps.

• Locate and examine all associated probes. Inspect the cables and strain relief at each end. Inspect the transducer enclosure and lens for cracks, holes and similar defects.

Electrical safety tests

CAUTION

For all instructions in this section in case of using a UPS (Uninterrupted Power Supply) the terms outle t, wall ou tle t, AC wall outlet and power outlet refer to the AC power outlet of the UPS. In case of further available AC (or DC) power outlets at the same used UPS, these must remain unused i.e. not connected to any other devices.

Ultrasound System – Common Service Information 4-17 Direction 5444964-100 English Rev. 5

Care and Maintenance

Safety test overview (continued)

WARNING

CAUTION

Users must ensure that safety inspections are performed whenever damage is suspected and on a regular basis in accordance with local authorities and facility procedures. DO NOT use the Ultrasound system or individual probes which fail any portion of the safety test.

To minimize the risk and avoid an electric shock, only trained persons are allowed to perform the electrical safety inspections and tests.

Compare all safety-test results with safety-test results of previously performed safety tests (e.g. last year etc). In case of unexplainable abrupt changes of safety-test results consult experienced authorized service personnel or GE for further analysis.

To avoid electrical shock, the Ultrasound system under test MUST NOT be connected to other electrical equipment. Remove all interconnecting cables and wires. The Ultrasound system under test must not be contacted by users or patients while performing these tests.

4-18 Ultrasound System – Common Service Information

Direction 5444964-100 English

Rev. 5

Leakage current limits

Electrical safety tests

WARNING

Energy Control and Power Lockout for Ultrasound System. When servicing parts of the Ultrasound system where there is

exposure to voltage greater than 30 volts:

1. Follow LOCK OUT/TAG OUT procedures.

2. Turn off the breaker.

3. Unplug the Ultrasound system from the wall outlet, then from the Ultrasound System.

4. Maintain exclusive control of the Ultrasound system power cable.

5. Wait at least 30 seconds for capacitors to discharge as there are no test points to verify isolation.

6. Remove/disconnect the battery if present.

Ultrasound System components may be energized. Capacitors on Ultrasound Systems with the Shearwave Option

can take up to 5 minutes to discharge. The following acceptance limits and test conditions are

summarized from IEC 60601-1/A1:2012 (ed.3.1) including national deviations and IEC 62353:2014 (ed.2) and in some cases are lower than that specified by the standards.

Because the main source of leakage current is the mains supply , there are different acceptance limits depending on the configuration of the mains (100-130 Volt, 220-240 Volt, or 230-240 Volt mains).

Ultrasound System – Common Service Information 4-19 Direction 5444964-100 English Rev. 5

Care and Maintenance

LOGIQ/Vivid/Voluson Ultrasound System Leakage Current Limits

Leakage current limits for LOGIQ, Vivid and VOLUSON Ultrasound Systems are shown below for 100-130 Volt and 220-240 Volt mains.

Table 4-6: Leakage current limits for Ultrasound system operation on 100-130 Volt

mains (US/Canada/Japan)

System

Leakage Current Test

Earth Leakage On and Off N /A

Chassis/Enclosure Leakage On and Off Closed

Type BF Applied Parts On (transmit) Closed

Type CF Applied Parts On (transmit) Closed

Type BF Applied Parts (sink leakage, mains voltage on applied part)

Type CF Applied Parts (sink leakage)

(1) UL 60601-1 standard

Power

On and Off Closed 5 5000

On and Off Closed 0.05 50

Grounding/

PE Conductor

Open

NOTE: Open Grounding is also known as “Lift Ground”.

Limit in mALimit in

µA

0.3

0.1

0.3

0.1

0.5

0.01

0.05

(1)

300 100

500 10

(1)

4-20 Ultrasound System – Common Service Information

Direction 5444964-100 English

Rev. 5

Electrical safety tests

LOGIQ/Vivid/Voluson Ultrasound System Leakage Current Limits (continued)

Table 4-7: Leakage current limits for Ultrasound system operation on 220-240 Volt

mains

System

Leakage Current Test

Earth Leakage On and Off N/A 0.5 500 Chassis/Enclosure Leakage On and Off Closed

Type BF Applied Parts On (transmit) Closed

Type CF Applied Parts On (transmit) Closed

Type BF Applied Parts (sink leakage, mains voltage on applied part)

Type CF Applied Parts (sink leakage, mains voltage on applied part)

Values based on IEC60601

Power

On and Off Closed 5 5000

On and Off Closed 0.05 50

Grounding/

PE Conductor

Open

Limit in

0.1

0.5

0.1

0.5

0.01

0.05

100 500

10 50

Table 4-8: ISO and Mains Applied Limits*

Probe Type Measurement

BF 5.0 mA (5000 µA)

Limit in

µA

CF 0.05 mA (50 µA)

*ISO and Mains Applied refers to the sink leakage test where mains (supply) voltage is applied to the applied part to determine the amount of current that will pass (or sink) to ground if a patient is in contact with mains voltage.

Ultrasound System – Common Service Information 4-21 Direction 5444964-100 English Rev. 5

Care and Maintenance

LOGIQ/Vivid/Voluson Ultrasound System Leakage Current Limits (continued)

NOTE: Electrical leakage testing may be accomplished with any

calibrated Electrical Safety Analyzer tool compliant with AAMI/ ESI 1993 or IEC 60601 or AS/NZS 3551 or IEC62353 or other relevant national regulation.

Table 4-9: Equipment Type and Test Definitions

Applied Parts (AP)

Type BF Type BF Applied Part (man in the box) symbol is in accordance with

Type BF Defib.-Proof

Type CF T ype CF Applied Part (heart in the box) symbol is in accordance with

Type CF Defib.-Proof

Sink Leakage The current resulting from the application of mains voltage to the applied part. This test

Parts or accessories that contact the patient to perform their function. For ultrasound equipment, this includes transducers, ECG leads and e-TRAX Needle Sensor.

IEC 60417-5333, e.g. ultrasound probes which are marked with the 'man in box' BF symbol.

Type BF defibrillation proof Applied Part (man in the box with p addle) symbol is in accordance with IEC 60417-5334, e.g. ECG electrodes which are marked with the 'man in box with paddle' BF symbol.

IEC 60417-5335, e.g. intraoperative probes for direct cardiac contact, isolated ECG connections and e-TRAX Needle Sensor, so marked with the 'heart in box' CF symbol.

Type CF defibrillation proof Applied Part (heart in the box with paddle) symbol is in accordance with IEC 60417-5336, e.g. intraoperative probes for direct cardiac contact, isolated ECG connections and e-TRAX Needle Sensor, so marked with the 'heart in box with paddle' CF symbol.

is required for Type BF and CF applied parts.

4-22 Ultrasound System – Common Service Information

Direction 5444964-100 English

Rev. 5

General Electric Ultrasound Common Service Information N 490042-02 Rév B

Specifications and Main Features

Frequently Asked Questions

User Manual

Ultrasound System

Table of Contents

Overview

Content in this manual

Product description

Products Covered in this Manual

Safety Information

Overview

Important conventions

Product Icons

Safety considerations

Label locations

Dangerous procedure warnings

Lockout/Tagout (LOTO)

Returning probes and repair parts

Electromagnetic compatibility (EMC)

Site Preparations

Overview

General Ultrasound system requirements

Facility needs

Care and Maintenance

Overview

Warnings

Why do maintenance

Maintenance task schedule

System maintenance

Using a Phantom

Electrical safety tests