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GE 8CH Foot Ankle Coil Operator Manual

GE 8CH Foot Ankle Coil


Operator Manual-English

Manufacturer:

GE HEALTHCARE (TIANJIN) COMPANY LIMITED


Address: No.266. JINGSAN ROAD,
TIANJIN AIRPORT ECONOMIC AREA,
TIANJIN, P.R. CHINA 300308

GE Catalog Number: M50002GF

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GE 8CH Foot Ankle Coil Operator Manual

Rev 10
June 2017

©2012 GE Healthcare Corporation


All rights reserved. No part of this publication may be reproduced, transmitted,
transcribed, stored in a retrieval system, or translated into any language in any form
by any means without the written permission of GE Healthcare Corporation.

Proper performance of this coil is guaranteed only while the coil is being used on the
MR system (hardware/software level) specified at the time of purchase. Upgrades or
other modifications to the system software and/or hardware may affect compatibility.
Prior to upgrading your MR system, please contact your GE Healthcare representative
to discuss coil compatibility issues. Failure to do so may void your warranty.

Medical Device Directive


These products conform with the requirements of council directive 93/42/EEC
concerning medical devices, when they bear the following CE Mark of Conformity.
The year of CE marking is 2014.

European Representative:
GE Medical Systems S.C.S.
283 rue de Ia Minière
78530 BUC France

In accordance with the international safety standard IEC 60601-1, this system is a
Class II device, acceptable for Continuous Operation, having ordinary protection
against ingress of water with type BF applied parts and is not for use in the presence
of flammable anesthetics

WARNING:
Equipment must be disposed of separately from unsorted municipal waste. Contact
an authorized manufacturer representative for information concerning disposal.

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TABLE OF CONTENTS
INTRODUCTION ....................................................................................................... 5
COMPATIBILITY ......................................................................................................... 5
EXPLANATION OF SYMBOLS ................................................................................ 5
CHAPTER 1 -GE 8CH FOOT ANKLE COIL CONTENTS .......................................... 7
CHAPTER 2 -SAFETY .............................................................................................. 8
2-1 Prerequisite Skills .............................................................................................. 8
2-2 Importance ......................................................................................................... 8
2-3 Quality Assurance .............................................................................................. 8
2-4 Cautions ............................................................................................................. 8
2-5 Contraindications ............................................................................................. 10
2-6 Precautions ...................................................................................................... 10
2-7 Emergency Procedures ................................................................................... 10
2-8 Technical Considerations ................................................................................ 10
2-9 Electrical and Mechanical Safety ..................................................................... 11
2-10 Incident Reporting .......................................................................................... 11
CHAPTER 3 -INSTALLATION AND MAINTENANCE ............................................. 13
3-1 Installation and Configuration ........................................................................ 13
3-2 Cleaning ......................................................................................................... 13
3-3 Storage ............................................................................................................ 13
3-4 Environmental Requirements .......................................................................... 13
CHAPTER 4 -QUALITY ASSURANCE ................................................................... 14
4-1 Purpose .......................................................................................................... 14
4-2 Tools Required ................................................................................................ 14
4-3 Positioning the Baseplate ................................................................................ 14
4-4 Securing the Phantom ..................................................................................... 14
4-5 Connecting the Cable ...................................................................................... 14
4-6 Coil Landmark .................................................................................................. 15
4-7 Multi-Coil Quality Assurance (MCQA) Tool...................................................... 16
CHAPTER 5-USING GE 1.5T 8CH FOOT ANKLE COIL ......................................... 20
5-1 Positioning the Baseplate ................................................................................ 20
5-2 Offset Positioning ............................................................................................. 20
5-3 Rotational Positioning ...................................................................................... 20
5-4 Pad Configuration ............................................................................................ 21

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5-5 Positioning the Patient ..................................................................................... 22


5-6 Positioning the Coil .......................................................................................... 22
5-7 Patient Hearing ................................................................................................ 22
5-8 Coil Connect to System ................................................................................... 23
5-9 Coil Landmark .................................................................................................. 23
CHAPTER 6 -SCANNING ......................................................................................... 24
6-1 Auto shim .......................................................................................................... 24
6-2 Localizing .......................................................................................................... 24
6-3 Fat Saturation Techniques ................................................................................ 24
6-4 Scan Protocols.................................................................................................. 24

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GE 8CH Foot Ankle Coil Operator Manual

INTRODUCTION

This manual describes the safety precautions, features, use and care of GE 8CH
Foot Ankle Coil, for use with the GE 1.5T MRI Systems. GE 8CH Foot Ankle Coil is
a receive-only coil. Please review this manual thoroughly before using the device.

If you have any questions or comments regarding this manual, or if you need any
assistance with the use of the product, please contact your GE Medical Systems,
sales representative.

COMPATIBILITY

The connector of GE 8CH Foot Ankle Coil is Port A+ 8CH Receive only plug, it can be
connected to the systems which is compatible with Port A+ plug, e.g. MR system with
Port A+ receptacle, Port B16 receptacle and so on. For the system compatibility with
the coil , please refer to system operator manual.

Indications for Use

GE 8CH Foot/Ankle Coil is a receive-only RF surface coil designed for use with 1.5T
MRI systems manufactured by GE Healthcare. GE 8CH Foot/Ankle Coil is indicated to
use for foot and ankle imaging. The nucleus excited is hydrogen.

EXPLANATION OF SYMBOLS

Manufacturer Name and Address

Manufactured Date

Serial Number

Model Number

Field Strength

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GE 8CH Foot Ankle Coil Operator Manual

Attention, Consult Accompanying Documents.

Type BF Equipment.

Class II Equipment.

Receive only

This symbol indicates that the waste of electrical


and electronic equipment must not be disposed
as unsorted municipal waste and must be
collected separately. Contact an authorized
representative of the manufacturer for information
concerning the decommissioning of your
equipment.
For the operator, there is a possibility of pinching
ones fingers.
Cables should not be looped or crossed, as
arcing and patient burns may result. Route cables
through the center of the magnet bore. Place
cables under the cushion whenever possible.
Routing near the sides of the bore increases the
likelihood of cable heating from induced currents.
Keep the length of the cable in the bore to a
minimum. Avoid bending the cable 180 degrees.
Route the cables out of the bore in the most direct
way, without looping or coiling.

General warning sign

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GE 8CH Foot Ankle Coil Operator Manual

CHAPTER 1 -GE 8CH FOOT ANKLE COIL CONTENTS

GE 8CH Foot Ankle Coil consists of the following parts. Please inspect upon
receipt to make sure all parts have arrived and are in good order. Use this guide
to refer to part names throughout this manual.

1 2

5 4

Contents
Description GE part #
1 GE 8CH Foot Ankle Coil 5459510
2 8CH Foot Ankle Coil Baseplate 5458752
3 Ankle Pad 5448720
4 Foot Pad 5448720-2
5 Ramp Pad 5448720-3

For the instruction of accessories replacement, please refer to GE 8CH Foot Ankle
Coil service manual (5443918-1EN).

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GE 8CH Foot Ankle Coil Operator Manual

CHAPTER 2-SAFETY

2-1 Prerequisite Skills


This manual contains detailed information regarding the set-up, positioning and use
of GE 8CH Foot Ankle Coil. The instructions must be read carefully and thoroughly
before attempting to scan patients with this coil.
This Manual is not intended to teach magnetic resonance imaging. It is necessary
for the user to have sufficient knowledge to competently perform the various
diagnostic imaging procedures within the user’s modality. This knowledge is gained
through a variety of educational methods including clinical working experience,
hospital based programs, and as part of many college and university Radiological
Technology programs.
2-2 Importance
• MRI system is very complex and precision equipment, the receiving coil is
an important part of this system, incorrect use and operation of the
equipment may cause serious damage, and even endanger the patient and
operator.
• Patient safety is critical; it should be the primary condition in the operation
and maintenance process to protect patients from electrical and mechanical
injury.
• Make sure your operator manual is available at any time, periodically review
operating procedures and safety precautions.
2-3 Quality Assurance
The procedure described in the Quality Assurance chapter of this manual should be
performed upon receipt of the coil to establish a baseline of coil performance. The
procedure should be repeated at regular intervals.
2-4 Cautions
The following general warning statements apply to scanning with a magnetic
resonance system. For further details review the warnings in your MR system
Operator manual.

Do not cross or loop cables. Arcing and patient burns could


result. Route cables out of the magnet so that they do not
touch the patient.

Please keep the electronic equipment (e.g. mobile phones) and magnet card
outside of magnetic shielding room. DO NOT take them into scanning,
electronic devices may be damaged, magnet card may be eliminated
magnetic, etc.

Assure that the patient is not touching the bore. If necessary, place pads
between the patient and the surface of the bore.

DO NOT use coil in the condition of flammable anesthetic gases and


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flammable air mixture, oxygen or nitrous oxide gas mixture.

If the patient complains warming, tingling, stinging, or similar sensations,


promptly stop the scan procedure, examine the patient, and contact the
responsible physician before continuing the procedure. Pay special attention
to very young, sedated, or other compromised patients who may not be able
to communicate effectively.

These equipments, Physiological monitors, ECG, respiratory gating and


auxiliary equipment including receiver coil ,may cause burns and other
injuries of patients, if they are not tested in MR environment to confirm
that they can be used. Please use special auxiliary equipment for MRI
system.

Patients with implanted ferromagnetic metal should not be scanned because


the magnetic field may interact with implanted surgical clips or other
ferromagnetic materials.

Persons with cardiac pacemakers or other implanted electronic devices


should not enter the magnetic field zone delineated by the MR system
manufacturer.

There is a risk to scanning feverish or decompensate cardiac patients.

Patients who have surgery history must accurately inform whether the me
tal or electronic items and other material items remain in his body.

Use thermal resistance materials or liner to prevent of direct contact between


patients and the cable connection, or may result in burns patients.

Facial makeup should be removed before scanning because it may contain


metal flakes which can cause skin and eye irritation. Permanent eyeliner
tattoos may cause eye irritation due to ferromagnetic particles.

Patients who work in environments in which there is a risk of having


embedded metallic fragments in or near the eye should be carefully
screened before undergoing an MR exam.

Visually inspect the cable insulator jackets, strain reliefs, and connector
boxes before each use. If the insulation is broken, or if the cable is frayed,
immediately discontinue use of the device.
Advise the patient to remain still throughout the scan to avoid nausea.
Patients shall be supervised at all times during scans.

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The patient should always be taken care during the scan.

Use only approved accessories.

2-5 Contraindications
MR system has a very strong magnetic field that may be hazardous to
persons entering the environment or the system room if they have certain
medical conditions or implanted devices.
When use this coil, please refer to the Contraindication of Use statement of your
compatible MR system.

2-6 Precautions

Precautions should be taken when scanning patients with the following conditions:
Greater than normal potential for cardiac arrest

Increased likelihood of seizures or claustrophobia

Unconscious, heavily sedated, or confused mental state

Inability to maintain reliable communications

Please refer to Chapter 2 Safety in your MR system Operator Manual or your MR


Safety Guide for additional and comprehensive MR safety information.

2-7 Emergency Procedures


If coil creates smoke, sparks, or makes an unusually loud noise, or if the patient
requires emergency assistance, perform these steps:
1. Stop the scan if one is in progress.
2. Unplug the coil from MR system by pulling the cable assembly.
3. Release the cradle by turning the handle at the end of cradle assembly.
4. Remove the patient from the scan room. Provide medical treatment, if needed.

2-8 Technical Considerations


The coil and accessories require special conditions regarding electromagnetic
compatibility. The coil must be installed and used in a shielded scan room
provided with the MR system.
The user must ensure that the scan room door is closed during system
scanning. Failure to do so may cause reciprocal interference with portable and
mobile RF communications equipment, affecting the performance of the
MR coil and/or such equipment
The coil should only be used with the accessories specified in this Operator
manual.
The use of accessories other than those specified in this Operator manual
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may result in decreased ESD (electrostatic discharge) immunity of the coil or


MR system, causing damage to the coil and/or system.

The coil should not be used with other coils or equipment present in the MR
scanner except as specified in this Operator manual.

The coil not used in scan should be placed in the place where the patie
nt can’t reach.
This device should not be used with other coil on MR scanner system,
unless the "Operator Manual" specifies.

Tampering with the cable pins and connector may damage connector and
affect coil or system performance. Please verify that connector and pins are
not damaged before use.

2-9 Electrical and Mechanical Safety

The coil consists of both electrical and mechanical components. The


electrical and mechanical assemblies and parts of the coil must be used with
care and should be routinely inspected.
Service personnel must have specialized training to ensure the safe
operating condition of the coil. Therefore, only properly trained and qualified
personnel should be authorized to service the coil.
Any changes or modifications to the coil must be approved and performed by
GE Medical Systems prior to installation.
Before using the coil, visually check it for any external damage. Do not use
the coil if the housing or cable is broken.

2-10 Incident Reporting


The user should contact GE Healthcare immediately to report an incident and/or injury
to a patient, operator, or maintenance employee that occurred as a result of coil
operation.
If an accident occurs as a result of coil operation, do not operate the equipment until
an authorized investigation is conducted.
For additional information, contact:
GE Healthcare America
USA………….800-558-5102
Canada………800-668-0732

GE Healthcare Europe
(33) 1-41-19-76-76

GE Healthcare Asia/Australia
China…………800-810-8188
Taiwan……….886-2-2505-7900
Singapore……65 6291 8528
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Australia……...61-7-33235000
Japan…………81-120-055-919
Korea………….82-1544-6119
India…………..91-80-28452923

European Representative:
GE Medical Systems S.C.S.
283 rue de Ia Minière
78530 BUC France

Turkey Importer Details:


GE Medical Systems Türkiye Ltd. Şti.
Esentepe Mah. Harman Sok. No: 8
34394 Şişli-İstanbul Türkiye

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GE 8CH Foot Ankle Coil Operator Manual

CHAPTER 3-INSTALLATION AND MAINTENANCE

3-1 Installation and Configuration


Coil installation and configuration must be done by the GE Service Representative.
GE Field Engineers shall consult the appropriate Service Instructions for installation.
3-2 Cleaning
The 1.5T 8Ch Foot Ankle Coil, patient comfort pads and baseplate must be cleaned
and stored using the following procedures:
1. Do not spray or sprinkle the cleansing fluid directly on the coil or cable or baseplate,
instead, use soft towel dip in cleansing fluid and clean them.
2. Wipe with a cloth that has been dampened in a solution of 10% bleach and 90% tap
water, or 30% isopropyl alcohol and 70% tap water.
3. Do not pour any cleaning solution directly on the coil or baseplate.
4 .Let the coil housing, baseplate, and pads dry before use.
5 .Under no circumstances should the coil be placed into any type of sterilizer.

3-3 Storage
Store the coil in an air-conditioned scan room or equipment room.
To store the coil and baseplate, a storage space of greater than 38.1cm x 40.6cm x
37.5cm (Depth X Width X Height) is required.

3-4 Environmental Requirements:


This equipment shall be transported, stored and operated under the following
conditions:
Transport/ Storage Operating conditions
Barometric Pressure 525hPa – 1017hPa 700hPa – 1017hPa
5% to 95%
Relative Humidity 30% to 60%
Non condensing
Temperature -40°C to +70°C 15°C to 21°C

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CHAPTER 4 -QUALITY ASSURANCE

4-1 Purpose
Perform system level Signal-to-Noise Check.
This procedure allows the user to check the coil elements for proper function. The
following steps give detailed instructions to perform this evaluation.
4-2 Tools Required

TOOLS REQURED-TABLE 4-1


Description GE part # Quantity
Small, Cylindrical Unified
5342680 1
Phantom
Cubical Unified Phantom 5342681 1

4-3 Positioning the Baseplate

The 1 .5T 8Ch Foot Ankle Coil is equipped with


a baseplate to support the coil. The baseplate is
designed to rest directly on the patient table for
stability. The coil cable should exit away from
the patient’s feet.

4-4 Securing the Phantom

Insert the Small cylindrical unified phantom and


Cubical unified phantom as illustrated. Use the
straps provided to secure the phantom to the
foot support.

Slide the coil onto the foot support. There are


no latches; the coil is held in place by gravity.

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4-5 Connecting the Cable
The connector of GE 8ch Foot Ankle Coil is Port A+ 8CH Receive only plug, it
can connect to the systems which can compatible with Port A+ plug, e.g. MR
system with Port A+ receptacle, Port B16 receptacle and so on. For the coil
connector type, please refer to system operator manual.

Do not cross or loop cables.


Arcing and patient burns could result.

The coil must be removed before the patient table is lowered down.

Leads cable from the backside of the coil, avoid contact with patients.

4-6 Coil Landmark

Advance the coil into the magnet and landmark on the handle as shown.

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4-7 Multi-Coil Quality Assurance (MCQA) Tool

WARNING: All RF coil related tests must be run on a system that is


well-calibrated and passing all system tests (The system should have
passed “Install In Spec” (IIS)), especially white pixel, correlated noise, and
MCR (Multi-Coil-Receive) tool.
From the Common Service Desktop (CSD) select, [Image Quality], Multi-Coil QA Tool
and Click here to start this tool. The MCQA Tool window will open as shown in Figure
4-7-1

Figure 4-7-1 Multi-coil QA Tool

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• The current coil field will be automatically filled in based on the Coil ID of the coil
connected to the LPCA.
• A warning (Figure 4-7-2) will pop up asking the user to select correct phantom set.
Click ‘OK” to continue.

Figure 4-7-2 Select Phantom Set Warning Popup

Select ‘Unified Phantom Kit’ as shown in Figure 4-7-3

Figure 4-7-3 Phantom set Drop-down manual

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Enter the Coil Serial # into the provided field.


From the MCQA Tool GUI, press the [Start] button to begin the test.
A warning (Figure 4-7-4) will pop up asking the user to continue. Click ‘Yes” to
continue.

Figure 4-7-4 Confirmation Warning Up


A warning (Figure 4-7-5) will pop up asking the user to verify the coil/phantom
set-up and position and verify that there is no large air bubbles in the phantom.
Ensure the phantom and coil setup is proper and select [Yes] to continue

Figure 4-7-5 Phantom/Coil Setup Warning Up

When the test is complete, test results display on the screen (Figure 4.7.6). The
PASS/FAIL status shows PASS if all coil elements are functioning properly. If any coil
elements display FAIL, call the GE Service Representative for coil repair

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Figure 4-7-6 Test Results


The MCQA Tool GUI displays Fail for reasons including, but not limited to:
- Bad coil element
- Incorrect phantom used for the test
- Incorrect positioning/placement of the phantom
Click on [Quit] button to exit MCQA Tool.
Remove coil and phantoms from the system bore.

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CHAPTER 5-USING GE 8CH Foot Ankle Coil

5-1 Positioning the Baseplate

The GE 8CH Foot Ankle Coil is


equipped with a baseplate to support
the coil. The baseplate is designed to
rest directly on the patient table for
stability.
For foot and ankle imaging, position the
baseplate toward the magnet end of the
patient table so that the patient can be
imaged supine and feet-first.
5-2 Offset Positioning

The foot support can be slided to left or


right side on the baseplate to
accommodate left or right foot and ankle
examinations. Here, the foot support is
shown in the left foot position.

Slide the foot support into position


desired.

5-3 Rotational Positioning

The foot support and coil is capable of


15 degree planter flexion.

Rotation is adjustable by means of a


latch at the base of the foot Support.

Move the latch clockwise, and the coil is


free to be adjusted. Move the latch
Counterclockwise and the Coil is locked
into position.

For the operator, there is a possibility of


pinching ones fingers.

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5-4 Pad Configuration

Three pads are included with GE 8CH Foot Ankle Coil.

The Ankle Pad is used to center the


ankle in the coil and it also offers patient
comfort

The Foot Pad provides patient comfort


and positions the foot not to be imaged
to reduce motion in the unaffected foot
and ankle during scans.

The knee pad supports the crus of


patient, provides patient comfort and
positions the body at the same time.

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5-5 Positioning the Patient

With the patient lying on the table, place


the foot to be imaged into the foot
support. The ankle pad will center the
ankle in the foot support.

Use the straps to immobilize the foot.

5-6 Positioning the Coil


Once the ankle and foot have been positioned and secured on the baseplate, slide
the coil onto the foot support as illustrated below. There are no latches; the coil is
held in place by gravity.

Ensure that the patient is not pinched when placing the coil onto the
baseplate

5-7 Patient Hearing

Provide ear plugs for the patient after all instructions have been given.
Hearing protection is required for all people in the scan room during a scan to prevent
hearing impairment. Acoustic levels may exceed 99 dB(A).
Hearing protection must have a Noise Reduction Rating (NRR) of 28 dB or better (e.g.,
30 dB, 32 dB, etc.)

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5-8 Connect coil to system


Connect GE 8CH Foot Ankle Coil cable to the system phased array port. The coil can
be connected to any of the HD phased array ports (A or B or C) depending on the
system configuration.
For the system configuration, please refer to your system operator manual.

5-9 Coil Landmark

Advance the patient into the magnet


and landmark on the LOGO as shown.

When scanning is completed, the coil


must be removed before lowering the
patient table

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CHAPTER 6 -SCANNING

6-1 Autoshim
Generally image quality is often improved by enabling autoshim. AUTOSHIM is a
feature of the GE MRI System to improve image quality. It does this by improving the
magnetic field homogeneity within the FOV selected. The improvement in image
quality is often dramatic when the selected FOV is far off center

6-2 Localizing
GE 8CH Foot Ankle Coil is designed to allow the body coil to be used while the coil is
connected to the scanner.
This allows use of a large FOV body coil localizer, which is helpful in determining the
left or right offset required for imaging the foot and ankle anatomical regions.
You may scan using the body coil at any time but the coil must be connected.

6-3 Fat Saturation Techniques


Off-center FOV imaging is a more difficult technique since it is dependent upon the
homogeneity of the magnetic field, and a definite fat peak signal. A small foot/ankle on
the edge of the imaginable field may produce poor fat saturation.
For best fat saturation results, position the patient as close to isocenter as possible
while ensuring that the unaffected foot is positioned away from the coil to avoid phase
wrap.
For axial imaging, use an axial localizer but before prescribing slices, localize using
the same FOV you intend to use in your study, or localize explicitly. Use of graphic
prescription from large FOV localizer sometimes results in software misuse producing
blank slices, shifted slices, or both.

6-4 Scan Protocols

GE Corporation recommends that you select imaging protocols that have been
established by your radiologist. Additionally you may refer to the GE protocols located
on the system.

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