Professional Documents
Culture Documents
Ultrasound System
Common Service Information
5444964-100 English
Rev. 6
DATE
REVISION (YYYY/MM/DD) REASON FOR CHANGE
REVISION REVISION
PAGE NUMBER NUMBER PAGE NUMBER NUMBER
Please verify that you are using the latest revision of this document. 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.
Note: 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 precedes the date of this CSI manual.
Translation policy
Trademarks
All products and their name brands are trademarks of their
respective holders.
Copyrights
© GE, 2013-2022.
All Rights Reserved.
Chapter 1 — Overview
Contents of 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 - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-22
Overview
Product Description
Vivid T8/T8 Pro Voluson E10 Versana Premier LOGIQ 5 LOGIQ e Vet*
* These products may include docking and isolation carts (with different electrical specifications).
Safety Information
Overview
Important Conventions
Icons
ELECTRICAL
MECHANICAL
RADIATION
LASER
HEAT
PINCH
Table 2-2: Standard Icons that Indicate that a Special Procedure is to be Used
Avoid Static Electricity Tag and Lock Out Wear Eye Protection
Product Icons
Safety Considerations
Introduction
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.
Human safety
• Operating personnel must not remove the Ultrasound
system covers.
• Servicing should be performed by authorized personnel
only.
Only personnel who have participated in your product’s
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.
Mechanical safety
WARNING Never use a probe that has fallen to the floor. Even if it looks
OK, it may be damaged.
CAUTION Use protective gloves when working with sharp edges or when
directed to wear PPE during a removal/replacement procedure.
CAUTION Use safety shoes when doing work where there is any chance
of foot injury.
WARNING The Ultrasound system should not be moved with the operator
I/O panel extended. Move the operator I/O panel to its centered
and locked position. Lower the operator I/O panel as much as
possible before moving the Ultrasound system.
CAUTION Always lock the top console (operating panel) in its parking
(locked) position before moving the Ultrasound system around.
CAUTION 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.
Electrical safety
Safe practices
Probes
Peripherals
Label Locations
Product labels
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.
Warnings
Warnings, such as the example below, precede potentially
dangerous procedures throughout this manual. Instructions
contained in the warnings must be followed.
Lockout/Tagout (LOTO)
LOTO requirements
Follow Lockout/Tagout 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.
All potentially hazardous stored or residual energy is relieved.
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 obtain 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.
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 from 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.
Site Preparations
Overview
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.
Cooling
Lighting
Electrical requirements
General requirements
Current or Power
Product Voltage Tolerance Consumption Frequency
Current/Power
Product Voltage Tolerance Consumption Frequency
100 VAC
LOGIQ 7 MAX. 1200 VA
115 VAC
220 VAC
100 VAC
LOGIQ 5 MAX. 1250 VA
115 VAC
230 VAC
100 VAC
LOGIQ 3 MAX. 860VA
115 VAC
230 VAC
Table 3-4: Electrical Specifications for LOGIQ C Series and LOGIQ C3/C5 Premium
220-240V~ 500VA
Current or
Power
Product Voltage Tolerance Consumption Frequency
Current or
Power
Product Voltage Tolerance Consumption Frequency
Current or
Power
Product Voltage Tolerance Consumption Frequency
100 VAC 8A
Vivid 4
120 VAC 8A
220-240 VAC 4A
100 VAC 8A
Vivid 3
120 VAC 8A
±10% 50/60 Hz
230 VAC 4A
Vivid E95
Vivid E90 100-240 VAC 700 W
Vivid E80
Current or
Power
Product Voltage Tolerance Consumption Frequency
Voluson P6 /
Voluson P8 100-240 VAC 900 VA
Current or
Power
Product Voltage Tolerance Consumption Frequency
Current or
Power
Product Voltage Tolerance Consumption Frequency
Current or
Power
Product Voltage Tolerance Consumption Frequency
Adapter for Vivid e 100 - 240 VAC ±10% 130 VA max. 1.3 A 50/60 Hz
(max.)
Current or
Power
Product Voltage Tolerance Consumption Frequency
Table 3-13: Docking Cart for LOGIQ e/LOGIQ e Vet/LOGIQ i/Vivid e/Vivid iq
Power Requirements
Input Output
Input Output
Input Output
Current or
Power
Product Voltage Tolerance Consumption Frequency
Current or
Power
Product Voltage Tolerance Consumption Frequency
100 VAC 8A
All models ±10% 50-60 Hz
110 VAC 8A
230 VAC 4A
Current or
Power
Product Voltage Tolerance Consumption Frequency
Power cable
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
• RFID access
• ID card readers
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.
EMI prevention/abatement
Be aware of Radio • Keep the Ultrasound system at least 5 meters (15 feet) away from other
Frequency sources EMI sources.
• Special shielding may be required to eliminate interference problems
caused by high frequency, high powered radio or video broadcast signals.
Ground the Ultrasound Poor grounding is the most likely reason an Ultrasound system will have
system noisy images. Check grounding of the power cord and power outlet.
Replace all screws, Radio • After you finish repairing or updating the Ultrasound system, replace all
Frequency gaskets, covers and tighten all screws.
covers, cores • 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.
Replace broken Radio If more than 20% or a pair of the fingers on a Radio Frequency gasket are
Frequency gaskets broken, replace the gasket. Do not turn on the Ultrasound system until any
loose metallic part is removed.
Do not place labels where Where applicable, never place a label where Radio Frequency gaskets meet
Radio Frequency gaskets the Ultrasound system. Otherwise, the gap created will permit Radio
touch metal Frequency leakage. Or, if a label has been found in such a position, move
the label.
Use GE specified The interconnect cables are grounded and require ferrite beads and other
harnesses and peripherals shielding. Also, cable length, material, and routing are all important; do not
change from what is specified.
Take care with cellular Cellular phones may transmit a 5 V/m signal; that could cause image
phones artifacts.
Properly route peripheral Where applicable, do not allow cables to lie across the top of the Card Rack
cables 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.
Facility Needs
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
Scale:
Each square equals one square
4 5 foot (app. 31 x 31 cm)
2 3
11
10
9
8 12
13
7
6 14
1
10 11 15
12
13 14 16
2 3 4 5
7
1
17
18
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
• 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
Overview
Warnings
Warnings
DANGER Do not pull out or insert circuit boards while power is on.
CAUTION Do not operate this Ultrasound system unless all board covers
and frame panels are securely in place. System performance
and cooling require this.
Why Do 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
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 quality assurance
program. Contact GE for coverage and/or price for service.
System Maintenance
Preliminary checks
The preliminary checks take about 15 minutes to perform. Refer
to the Ultrasound system user documentation whenever
necessary.
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
Ultrasound system options.
3. Power up • Turn the Ultrasound system power on and verify that all fans and
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.
4. Probes Verify that the Ultrasound system properly recognizes all probes.
5. Displays Verify proper display on the monitor and touch panel (where present).
7. Review Error Logs Where applicable, Error Logs can be reviewed via system diagnostics.
8. Diagnostics Optional.
10. Image Archive Back up the Image Archive onto appropriate media.
Functional checks
The functional checks take about 60 minutes to perform. Refer
to the Ultrasound system user documentation whenever
necessary.
System checks
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
available). Check the basic Ultrasound system controls that affect this
mode of operation.
4. M-Mode Verify basic M-Mode operation. Check the basic Ultrasound system
controls that affect this mode of operation.
8. Probe Elements Perform an Element Test on each probe to verify that all the probe
elements and Ultrasound system channels are functional, where
applicable.
11. Transmit/Receive Verify that all system XMIT/RECV channels are functional, where
applicable.
14. Touch Panel Where applicable, verify basic Touch Panel display functions.
Peripheral/option checks
2. B/W Printer Verify hardcopy output of the B/W video page printer. Clean heads and
covers if necessary.
3. Color Printer Verify hardcopy output of the Color video page printer. Clean heads and
covers if necessary.
7. Other For tablets and other external peripherals, check peripheral manuals for
functional checks if applicable.
1. Unplug Cord Disconnect the mains cable from the wall and Ultrasound system.
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.
Physical inspection
NOTE: These features may not be present on all Ultrasound systems.
1. Labeling Verify that all Ultrasound system labeling is present and in readable
condition.
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
aligned with other covers. Replace any covers that are damaged.
4. Operating Panel Inspect alphanumeric keyboard and operator panel (operator control
panel). Record any damaged or missing items.
5. Operating Panel • Where applicable, verify ease of operating panel (operator control panel)
Movement movement in all acceptable directions.
• Where applicable, ensure that it latches in position as required.
6. Operating Panel Check for proper operation of all operating panel and TGC lights.
Lights
7. Display (Monitor) Inspect the display for scratches and bad pixels.
Verify proper operation of contrast and brightness controls.
Where applicable, confirm that the display 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: Display arm movement may vary and is not applicable to all
Ultrasound systems.
8. Monitor Light Check for proper operation of any monitor lights, if available.
10. External I/O Check all connectors for damage and verify that the labeling is good.
11. Wheels and • Where applicable, check all wheels and casters for wear and verify
Brakes operation of foot brake and release mechanism.
• Where applicable, check all wheel locks and wheel swivel locks for
proper operation.
12. Cables and Check all internal cable harnesses and connectors for wear and secure
Connectors connector seating. Pay special attention to footswitch assembly and probe
strain or bend reliefs.
13. Shielding and Check to ensure that all EMI shielding, internal covers, air flow panels and
Covers screws are in place. Missing covers and hardware could cause EMI/RFI
problems while scanning.
14. Control Panel Inspect alphanumeric keyboard and operating panel. Record any
damaged or missing items.
15. Probe Holders Where applicable, inspect the probe holders for cracks or damage.
16. Power and Check for proper operation of all Power and System Status indicators.
System Status
Indicators
17. Battery Where applicable, check that the battery is not damaged, does not leak,
does not emit an odor, and is not deformed or discolored. Observe all
warnings and cautions for battery handling, recharging, storing, and/or
disposal.
18. External Where applicable, check for proper operation of any external microphones
Microphone by recording an audio test.
Cleaning
Refer to the User Manual for the Ultrasound system for
instructions.
Probe maintenance
Refer to the Ultrasound system User Manual, the probe’s User
Manual/Probe Care Card, or the Probe Addendum (p/n
5661328) for probe maintenance, checks, cleaning, and
disinfecting instructions.
CAUTION Disinfect a defective probe before you return it. Be sure to tag
the probe as being disinfected.
Using a Phantom
Phantoms
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 Program
tests.
1. Patient environment
DANGER To minimize the risk and avoid an electric shock, only trained
persons are allowed to perform the electrical safety inspections
and tests.
Table 4-6: Leakage Current Limits for Ultrasound System Operation on 100-240 Volt
Mains
*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.
Applied Parts Parts or accessories that contact the patient to perform their function. For Ultrasound
(AP) equipment, this includes transducers, ECG leads and e-TRAX Needle Sensor.
Type BF Type BF Applied Part (man in the box) symbol is in accordance with
IEC 60417-5333, e.g. ultrasound probes which are marked with the
'man in box' BF symbol.
Type BF Type BF defibrillation proof Applied Part (man in the box with paddle)
Defib.-Proof symbol is in accordance with IEC 60417-5334, e.g. ECG electrodes
which are marked with the 'man in box with paddle' BF symbol.
Type CF Type CF Applied Part (heart in the box) symbol is in accordance with
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 Type CF defibrillation proof Applied Part (heart in the box with
Defib.-Proof 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.
Sink Leakage The current resulting from the application of mains voltage to the applied part. This test
is required for Type BF and CF applied parts.
NOTE: No outlet tester can detect the condition where the Neutral
(grounded supply) conductor and the Grounding (protective
earth) conductor are reversed. If later tests indicate high leakage
currents, this should be suspected as a possible cause and the
outlet wiring should be visually inspected.
Grounding continuity
DANGER Electric Shock Hazard!
The patient or operator MUST NOT come into contact with the
equipment during this test.
Electrical
Hazard
Measure the resistance from the third pin of the attachment plug
to the exposed metal parts of the case.
The ground wire resistance should comply with the procedure
used for the test.
• For IEC 60601-1, the expected result is less than 0.2 ohms.
• For IEC 62353, the expected result is 0.3 ohms.
• For NFPA 99, the expected result is 0.5 ohms.
NOTE: In some countries/regions differing acceptance limits and
differing test conditions may apply.
Electrical
Hazard
Definition
Generic procedure
The test verifies the isolation of the power line from the chassis.
The testing electrical safety analyzer is connected from
accessible metal parts of the case to ground. Measurements
should be made under the test conditions specified in Table 4-6
on page 4-19, as applicable.
Record the highest reading of current.
1. Connect the safety analyzer to wall AC wall outlet.
2. Plug the equipment under test into the receptacle on the
panel of the electrical safety analyzer.
3. Connect the electrical safety analyzer to an accessible
metal surface of the Ultrasound system using the cable
provided with the electrical safety analyzer.
4. Select the “Chassis” or “Enclosure Leakage” function on the
electrical safety analyzer.
5. Test opening and closing the ground with the Ultrasound
system on and off as indicated in Table 4-6 on page 4-19 as
applicable.
NOTE: For more information, refer to the safety analyzer’s user
manual that will be used to perform the tests.
The maximum allowable limit for chassis source leakage is
shown in Table 4-6 on page 4-19, as Chassis/Enclosure
Leakage.
Potential
System Grounding/ Limit equilibrium Monitor Probe
Power PE µA connector housing connector
on closed 100
on open 500
on closed 100
(reversed
polarity)
Definition
This test measures the current which would flow to ground from
any of the isolated ECG leads. The electrical safety analyzer
simulates a patient who is connected to the monitoring
equipment and is grounded by touching some other grounded
surface.
Measurements should be made with the ground open and
closed, with power line polarity normal and reversed, and with
the Ultrasound system on and off (per IEC 62353 and/or IEC
60601-1).
For each combination the operating controls, such as the lead
switch, should be operated to find the worst case condition.
Generic procedure
Figure 4-3. Set Up for Test of Earth Leakage Current, IEC 60601-1
NOTE: Not all test procedures are applicable to all areas of the world.
Reversed Polarity testing content satisfies regions following
IEC 62353 and IEC 60601-1.
NOTE: Values in italics font are given as examples only.
Table 4-10: Typical Data Format For Recording Patient Lead To Ground (GND)
Leakage
(RA+LA+
System Limit RA to LA to LL to LL) to
Power Grounding/PE µA GND GND GND GND
off closed 10
off open 50
on closed 10
on open 50
on closed (reversed 10
polarity)
on open (reversed 50
polarity)
Table 4-11 on page 4-30 shows a typical format for recording the
patient lead to lead leakage current.
Measurements should be recorded from each lead
combination under each set of test conditions specified in
Table 4-6 on page 4-19, as applicable.
Record all data and keep the record of the results with other
hard copies of maintenance data.
1. Connect the safety analyzer to a wall AC power outlet.
2. Plug the equipment under test into the receptacle on the
electrical safety analyzer's panel.
3. Connect the ECG cable to the Ultrasound system and the
patient leads to the analyzer.
4. Select the “Patient Lead Leakage” function on the electrical
safety analyzer.
5. Test opening and closing the ground with the Ultrasound
system on and off.
NOTE: Refer to the safety analyzer’s user manual that will be used
to perform the tests.
Keep a record of the results with other hard copies of
maintenance data using Table 4-11.
NOTE: Not all test procedures are applicable to all areas of the world.
Reversed Polarity testing content satisfies regions following
IEC 62353 and IEC 60601-1.
NOTE: Values in italics font are given as examples only.
Table 4-11: Typical Data Format For Recording Patient Lead To Lead Leakage
(RA+LA+
System Limit LL) to
Power Grounding/PE µA RA to LA LA to LL LL to RA GND
off closed 10
off open 50
on closed 10
on open 50
on closed (reversed 10
polarity)
on open (reversed 50
polarity)
DANGER Line voltage is applied to the ECG leads during this test. To
avoid possible electric shock hazard, the Ultrasound system
being tested must not be touched by patients, users or anyone
while the ISO TEST switch is depressed.
Electrical
Hazard
Table 4-12: Typical Data Format For Recording Isolated Patient Lead (Sink) Leakage
off closed 50
on closed 50
DANGER Do not use the probe if the insulating material has been
punctured or otherwise compromised. Integrity of the insulation
material and patient safety can be verified by safety testing
according to IEC 60601-1.
Definition
This test measures the current that would flow to ground from
any of the probes through a patient who is being scanned and
becomes grounded by touching some other grounded surface.
NOTE: Each probe will have some amount of leakage, dependent on its
design. Small variations in probe leakage currents are normal
from probe to probe. Other variations will result from differences
in line voltage and test lead placement. It is abnormal if no
leakage current is measured. If no leakage current is detected,
check the configuration of the test equipment.
2 1
9
8
5
3
4 7
6
A
1. Ultrasound system 4. Ground switch 7. Isolator
2. Electrical safety analyzer 5. Polarity reversing switch 8. Ultrasound probe
3. Neutral switch 6. Meter 9. Saline probe
NOTE: Each probe will have some amount of leakage, dependent on its
design. Small variations in probe leakage currents are normal
from probe to probe. Other variations will result from differences
in line voltage and test lead placement. It is abnormal if no
leakage current is measured. If no leakage current is detected,
check the configuration of the test equipment.
The Ultrasound probes imaging area is immersed in the saline
solution along with a grounding probe from the electrical safety
analyzer to complete the current path.
This test is also known as Patient Leakage Current.
1. Turn the Ultrasound system OFF
2. Connect the safety analyzer to AC wall outlet.
3. Set the safety analyzer's function switch to “Chassis” or
“Enclosure Leakage”.
4. Plug the Ultrasound system’s power cord into the Electrical
Safety Analyzer.
5. Plug the Chassis Ground Probe (saline probe) into the
Electrical Safety Analyzer's “CHASSIS” connector.
6. Connect the Ultrasound probe to the Ultrasound system.
7. Immerse the Saline probe in the saline solution.
8. Immerse the Ultrasound probe’s face (imaging area of the
probe) into the saline solution.
NOTE: Not all test procedures are applicable to all areas of the world.
Reversed Polarity testing content satisfies regions following
IEC 62353 and IEC 60601-1.
NOTE: Values in italics font are given as examples only.
Table 4-13: Typical Data Format For Recording Probe (Source) Leakage Current
Limit
System Grounding/ AC/DC
Power PE µA probe1 probe2 probe3 probe4
on closed 100/10
on open 500/50
on closed 100/10
(reversed
polarity)
DANGER Do not use the probe if the insulating material has been
punctured or otherwise compromised. Integrity of the insulation
material and patient safety can be verified by safety testing
according to IEC 60601-1.
DANGER Line voltage is applied to the ultrasound probe during this test.
To avoid possible electric shock hazard, the system being
tested must not be touched by patients, users or anyone while
the ISO TEST switch is depressed.
Electrical
Hazard
Table 4-14: Typical Data Format for Recording Isolated Probe (Sink) Leakage
on closed 5000
on closed 5000
(reversed
polarity)
NOTE: Mains Applied refers to the sink leakage test where mains
(supply) voltage is applied to the part to determine the amount of
current that will pass (or sink) to ground if a patient contacted
mains voltage.
Mains on applied part is one of the described leakage current
tests applicable for probes (Ref: IEC 60601-1). This is to be
performed with the probe disconnected from the Ultrasound
system. Apply mains voltage over the insulation barrier.
(Between protective earth on the probe connector, and an
electrical anode in saline solution. The patient applied part of the
probe is immersed into the saline solution.) Measure current
flowing in the circuit = leakage current.
As a minimum, tests according to IEC 60601-1 must be
performed once a year. The requirements for Body Floating (BF)
have to be applied for TEE and Trans thorax probes bearing the
symbol for safety class BF.
The symbol for BF is indicated on the probe connector label
below:
AC/DC fails
Where applicable, check the AC/DC adapter and its cable.
Replace a new one if any portion is defective.
Chassis fails
Check the ground on the power cord and plug for continuity.
Ensure the ground is not broken, frayed, or intermittent. Replace
any defective part.
Where applicable, tighten all grounds. Ensure star washers are
under all ground studs.
Inspect wiring for bad crimps, poor connections, or damage.
Test the wall outlet; verify it is grounded and is free of other
wiring abnormalities. Notify the user or owner to correct any
deviations. As a work around, check the other outlets to see if
they could be used instead.
NOTE: No outlet tester can detect the condition where the white neutral
wire and the green grounding wire are reversed. If later tests
indicate high leakage currents, this should be suspected as a
possible cause and the outlet wiring should be visually
inspected. If reversed wiring is observed, it is the customers
responsibility to have the condition corrected by qualified
personnel.
Probe fails
Test the probe in another connector to isolate if the fault lies with
the probe or the Ultrasound system.
NOTE: Each probe will have some amount of leakage, dependent on its
design. Small variations in probe leakage currents are normal
from probe to probe. Other variations will result from differences
in line voltage and test lead placement. The maximum allowable
leakage current for body surface contact probe differs from
inter-cavity probe. Be sure to enter the correct probe type in the
appropriate space on the check list.
If excessive leakage current is slot dependent, inspect the
Ultrasound system connector for bent pins, poor connections,
and ground continuity.
If the problem remains with the probe, replace the probe.
Peripheral fails
Tighten all grounds. Ensure star washers are under all ground
studs.
Inspect wiring for bad crimps, poor connections, or damage.
Still fails
If all else fails, begin isolation by removing the probes, external
peripherals, then the on board ones, one at a time while
monitoring the leakage current measurement.
Where applicable, in the case of using a UPS (uninterruptible
power supply), perform the tests in the “Electrical Safety tests”
section without using the UPS (i.e. directly connect the
Ultrasound system to the AC wall outlet). If this leads to a pass
result, the specific UPS must no longer be used.
ECG fails
Inspect cables for damage or poor connections.
Quality checks
Contact your GE Service Representative to perform Equipment
and Image Quality Checks.
Based on the region/area of the world that the customer is
based in, the customers Quality Assurance Program may
require alignment with local standards. Thus, all testing per IEC
60601 and/or IEC 62353 may or may not be required for EQC
Care and Maintenance.
For example, United States National Standards for Health Care
Facilities (NFPA 99) only requires touch current testing in normal
operating configurations (this standard differs from IEC 62353
requirements for recurrent test and test after repair of medical
electrical equipment).
A EMC
compliance, 2-23
acclimate time, 3-3 electromagnetic compatibility, 2-23
what is EMC?, 2-23
B EMI
abatement, 3-19
before installation (site preparations), 3-1 prevention, 3-19
EMI limitations, 3-18
C environmental requirements, 3-3
environmental specifications
cable inspection for ultrasound system, 3-4
mains cable inspection, 4-8 EQC
Care and Maintenance, 4-2 ultrasound equipment quality check, 4-44
care and maintenance, 4-1 errors, i-7
warnings, 4-3 ESD prevention, 2-24
CE compliance, 2-23
chassis leakage current test, 4-23 F
cold or hot
if the ultrasound system is very cold or hot, 3-3 facility needs, 3-21
compliance, 2-23 desirable features, 3-25
conventions used in book, 2-3 purchaser responsibilities, 3-21
cooling, 3-4 required facility needs, 3-23
copyrights, i-8 functional checks, 4-7
mains cable inspection, 4-8
D
G
dangerous procedure warnings, 2-19
desirable features, 3-25 general ultrasound system requirements, 3-3
electrical requirements, 3-5
E generic procedure on probe leakage current, 4-34
grounding continuity, 4-22
electrical requirements, 3-5, 3-17
EMI limitations, 3-18 H
general ultrasound system requirements, 3-5
requirements for the ultrasound system, 3-5 hot or cold
site circuit breaker if the ultrasound system is very cold or hot, 3-3
site circuit breaker, 3-17 how often should maintenance tasks be performed?,
site power outlets 4-5
site power outlets, 3-17 human safety, 2-8
electrical safety, 2-16
electrical safety tests, 4-14 I
electromagnetic compatibility (EMC), 2-23
electromagnetic interference icons, 2-3
abatement, 3-19 icons indicating a special procedure to be used, 2-6
prevention, 3-19 if the ultrasound system is very cold or hot, 3-3
electrostatic discharge prevention, 2-24 important precautions, i-2
isolated patient lead (source)
leakage lead to ground, 4-26
leakage lead to lead, 4-29
R
required facility needs, 3-23
requirements
ultrasound system, 3-3
returning/shipping probes and repair parts, 2-21
revision history, i-1
Manufacturer:
GE Medical Systems
www.gehealthcare.com