GE 5160986-2 User manual

Operator’s Manual English
4535-303-04992 Rev B
1.5T and 3.0T 8ch Wrist Array Coils
1.5T HD 8ch Wrist Array (Receive only)
3.0T HD 8ch Wrist Array
1.5T HD 8ch Wrist Array (Flat base)
3.0T HD 8ch Wrist Array (Flat base)
1.5T 8ch Wrist Coil, with a P-Port connector
Veenpluis 6
5684 PC Best
The Netherlands
www.dunlee.com/healthcare
GE Healthcare
Revision B, 03/2022

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March 2022
Licenses and Trademarks
© 2022 Dunlee
Dunlee reserves the right to make changes to both this Instructions for Use and to the product it
describes. Product specifications are subject to change without notice. Nothing contained within this
Instructions for Use is intended as an offer, warranty, promise or contractual condition, and must not be
taken as such.
All Rights are reserved. Reproduction in whole or in part in any form or by any means, electrical,
mechanical or otherwise is prohibited without the written consent of the copyright holder.
Unauthorized copying of this publication may not only infringe copyright and reduce the ability of Dunlee
to provide accurate and up-to-date information to users. “Non-Philips product names may be trademarks
of their respective owners”.
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.
Your operator’s manual and Instructions for Use are available electronically at:
www.dunlee.com/IFU
GE European Contact
GE Healthcare S.C.S.
283 rue de la Minière
78530 BUC France
Philips Authorized Swiss
Representative
Philips AG
Seestrasse87
CH-8810 Horgen
Australian Sponsor
Philips Electronics Australia
Ltd
65 Epping Road, North Ryde,
NSW,
Australia 2113

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Table of Contents
1 Introduction ................................................................................................................................................ 6
Residual risks....................................................................................................................................... 6
Device description............................................................................................................................... 6
Indications for use............................................................................................................................... 6
Contraindications................................................................................................................................ 7
Basic Operating Principles................................................................................................................... 7
Target patient groups ......................................................................................................................... 7
Intended users .................................................................................................................................... 7
Clinical benefits and undesirable side effects..................................................................................... 7
Compatibility....................................................................................................................................... 8
2 Explanation of Symbols............................................................................................................................... 9
3 Wrist Array and Accessories ..................................................................................................................... 15
4 Safety ........................................................................................................................................................ 17
Training ............................................................................................................................................. 17
Precautions ....................................................................................................................................... 17
Cautions/potential hazards............................................................................................................... 17
Emergency procedures ..................................................................................................................... 18
Technical considerations................................................................................................................... 18
5 Using the Wrist Array Coils ....................................................................................................................... 20
Choosing the best coil position......................................................................................................... 20
Workflow Imaging with the Wrist at the patient side ...................................................................... 20
5.2.1 Positioning the base plate......................................................................................................... 20
5.2.2 Mount the coil on the base plate.............................................................................................. 20
5.2.3 Pad configuration...................................................................................................................... 21
5.2.4 Unlatch coil ............................................................................................................................... 21
5.2.5 Positioning the patient.............................................................................................................. 21
5.2.6 Locking the coil.......................................................................................................................... 22
5.2.7 Landmark .................................................................................................................................. 22

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5.2.8 After scanning............................................................................................................................22
Workflow Imaging with the Wrist over the Patient’s Head (Superman) ..........................................22
5.3.1 Positioning the baseplate for Imaging with the Wrist over the Patient’s Head........................22
5.3.2 Attaching the Baseplate Riser ...................................................................................................23
5.3.3 Locking the Baseplate Riser.......................................................................................................23
5.3.4 Attaching Coil.............................................................................................................................23
5.3.5 Unlatch Coil ...............................................................................................................................24
5.3.6 Positioning the Patient ..............................................................................................................24
5.3.7 Locking the Coil..........................................................................................................................24
5.3.8 Coil Landmark............................................................................................................................24
Connecting the cable to the system..................................................................................................25
Patient hearing protection ................................................................................................................25
6 Scanning ....................................................................................................................................................26
Autoshim ...........................................................................................................................................26
Localizer scans ...................................................................................................................................26
Fat Saturation Techniques.................................................................................................................26
Scan protocols ...................................................................................................................................26
7 Installation and Maintenance....................................................................................................................27
Installation and configuration ...........................................................................................................27
Quality assurance ..............................................................................................................................27
7.2.1 Tools required............................................................................................................................27
Ambient operating conditions...........................................................................................................27
Storage...............................................................................................................................................27
7.4.1 Storage Location........................................................................................................................27
7.4.2 Space required...........................................................................................................................28
Disassembly of Coil............................................................................................................................28
7.5.1 Unlatch Coil ...............................................................................................................................28
7.5.2 Detaching Coil............................................................................................................................28
Product End of Life ............................................................................................................................28
8 Cleaning and disinfection ..........................................................................................................................29

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Cleaning............................................................................................................................................. 30
Disinfection ....................................................................................................................................... 30
Spaulding classification ..................................................................................................................... 30
Recommended cleaning agents........................................................................................................ 30
Recommended disinfection agents .................................................................................................. 30
Cleaning and disinfectant agent warnings........................................................................................ 31
9 Prevention................................................................................................................................................. 32
Preventing residue on MR coil.......................................................................................................... 32
Cleaning and disinfection frequency................................................................................................. 32
10 Cleaning and disinfecting procedure for non-critical diagnostic MR coils and pads............................ 33
Inspection.......................................................................................................................................... 33
General cleaning instructions ........................................................................................................... 33
Disinfecting instructions ................................................................................................................... 34
11 EMC Information................................................................................................................................... 35
12 Complaints ............................................................................................................................................ 37

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1Introduction
This manual describes the safety precautions, features, use and care of the GE Orthopedic Coils: 1.5T and
3.0T HD 8ch Wrist Array Coils and 8ch Wrist Coils with a P-Port Connector (all referred to as Wrist Array
Coils for the rest of this document), for use with GE 1.5T or 3.0T MRI Systems. The Wrist Array Coils are
Receive-Only coils. Please review the manual thoroughly before using the device.
Pay special attention to all the information given and procedures described in the SAFETY section
Warning
A Warning alerts you to a potential serious outcome, adverse event or safety hazard. Failure
to observe a warning may result in death or serious injury to the user or patient.
Caution
A Caution alerts you to where special care is necessary for the safe and effective use of the
product. Failure to observe a caution may result in minor or moderate personal injury or
damage to the product or other property, and possibly in a remote risk of more serious
injury, and/or cause environmental pollution.
Note
Notes highlight unusual points as an aid to a user.
If you have any questions or comments regarding this manual or need any assistance with the use of the
product, please contact your GE Healthcare representative.
Residual risks
To ensure that a procedure is safely performed, follow this instruction and the MR system instructions for
use.
Device description
The Wrist Array coils are a phased array design to be used vertically at the patient’s side or horizontally
overhead on the GE MR system. The wrist array comes with two rigid base plates (for flat or curved
tabletops) for fixation to reduce patient motion. The coil receives magnetic resonance signals generated
in hydrogen nuclei (protons) in the wrist while blocking the high-frequency magnetic field applied by the
MRI scanner at specified timings. Images are typically generated as axial, sagittal, coronal oblique slices
and include coverage of the wrist anatomy.
Indications for use
The 1.5T 8ch Wrist Coil is intended to be used in conjunction with a GE 1.5T Magnetic Resonance
Scanner to produce diagnostic images of the wrist anatomy that can be interpreted by a trained
physician.
The 3.0T 8ch Wrist Coil is intended to be used in conjunction with a GE 3.0T Magnetic Resonance Scanner
to produce diagnostic images of the wrist anatomy that can be interpreted by a trained physician.

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.Contraindications
There are no specific contraindications for MR Rx coils. However, general contraindications for MRI
examinations do exist. The operator should be aware of the following contraindications for use related to
the strong magnetic field of the MR system:
•Scanning is contraindicated for patients who have electrically, magnetically or mechanically activated
implants (cardiac pacemakers, for example). The magnetic and electromagnetic fields produced by
the MR System and coil may interfere with the operations of these devices.
•Scanning patients with intracranial aneurysm clips is contraindicated.
Basic Operating Principles
This RF coil is designed for use with GE MRI scanners with HD or P-port connectors. The coil receives
magnetic resonance signals generated in hydrogen nuclei (protons) in the human body while blocking the
radio frequency magnetic field applied by the MRI system at specified timings. The received signal is
amplified and transmitted to the MRI system, where it is processed into tomographic images by the
computer.
Target patient groups
The target population for MR Wrist Array coils used with GE scanners includes adults and pediatric
patients that require an MRI exam of the Wrist.
Intended users
The MRI is intended for use in a professional healthcare facility environment. The coil is to be used by a
trained MR technician/Radiographer only
Clinical benefits and undesirable side effects
Magnetic resonance images are noninvasive and do not employ ionizing radiation. The technique relies
on a different principle for image production than other imaging techniques. An MR image represents the
relative response of specific nuclei to absorbed radio frequency energy. Similar to other imaging
techniques, this image is a function of density, in this case, the distribution of the nuclei being observed.
However, image contrast is also influenced by other physical factors, including differences in the ability to
re-emit the absorbed radio frequency signal (relaxation), and flow phenomena. This dependence on
multiple parameters means that the information content of an MR image is very different from an X-ray
or ultrasound image.
Most MR images are designed to observe the hydrogen nucleus because of its relative abundance in the
body. Thus, an MR image is usually a tomographic map of the distribution of protons in the imaged
sample. Furthermore, the relative appearance of normal versus pathologic tissue can be modified by
altering specific elements of the acquisition protocol to emphasize different physiochemical
characteristics of specific protons, assuring exceptional tissue contrast across a wide range of tissue
types. The imaging sequences can even be modified to visualize blood flow and to compensate for the
blurring effects of cardiac or respiratory motion.
MR also offers the unique ability to acquire images in virtually any orientation, without repositioning the
patient. This translates into greater convenience for medical staff and minimized patient discomfort. Plus,

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March 2022
magnetic resonance provides chemical information not measurable with conventional radiography or
ultrasonography. It is the combination of versatility, sensitivity and specificity as a diagnostic modality
that has accelerated the acceptance of MRI.
No undesirable side effects have been identified with the use of coils. Refer to the MR System
Instructions for Use/Operations manual for any undesirable side effects related to the use of MR
scanners.
Compatibility
The Wrist Array Coils are compatible with the following GE systems and connectors. Consult your GE
representative for Software level requirements.
Dunlee Part
number
GE Part
numbers
Description
Field
Strength
Connector
Table
Geometry
4535-300-8344*
107293 (as
appears on rating
label)
5160986-2
HD 8ch Wrist Array
(Receive only)
1.5T
HD connector
Curved
3000-073-1409*
5160986-2
HD 8ch Wrist Array
(Receive only)
1.5T
HD connector
Curved
4535-302-1916*
5268024-2
HD 8ch Wrist Array
3.0T
HD connector
Curved
3000-072-9275*
5268024-2
HD 8ch Wrist Array
3.0T
HD connector
Curved
4535-303-1519*
5406395-2
HD 8ch Wrist Array
1.5T
HD connector
Flat
3000-074-0377*
5406395-2
HD 8ch Wrist Array
1.5T
HD connector
Flat
4535-303-1542*
5406655-2
HD 8ch Wrist Array
3.0T
HD connector
Flat
3000-074-4656*
5406655-2
HD 8ch Wrist Array
3.0T
HD connector
Flat
4598-014-1222*
5790142-2
8ch Wrist Coil
1.5T
P-Port connector
Curved
* Represents the revision number

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2Explanation of Symbols
Device
Transport and Storage
Requirements
Title of Symbol
Designation /
Reference number
Reference Standards
Description of Symbol
Fragile; handle
with care
ISO 15223-1,
Symbol 5.3.1
IEC 60878
Symbol 0621
ISO 15223-1: Medical devices -
Symbols to be used with
medical device labels, labelling
and information to be supplied
- Part 1: General requirements
IEC 60878: Graphical symbols
for electrical equipment in
medical practice
Indicates a medical device
that can be broken or
damaged if not handled
carefully.
Keep dry
ISO 15223-1,
Symbol 5.3.4
IEC 60878
Symbol 0626
ISO 15223-1: Medical devices -
Symbols to be used with
medical device labels, labelling
and information to be supplied
- Part 1: General requirements
IEC 60878: Graphical symbols
for electrical equipment in
medical practice
Indicates the product
package and the medical
device needs to be protected
from moisture.
Temperature
limit
ISO 15223-1,
Symbol 5.3.7
IEC 60878
Symbol 0632
ISO 15223-1: Medical devices -
Symbols to be used with
medical device labels, labelling
and information to be supplied
- Part 1: General requirements
IEC 60878: Graphical symbols
for electrical equipment in
medical practice
Indicates the temperature
limits to which the medical
device and its packaging can
be safely exposed. The upper
and lower limits are shown
adjacent to the upper and
lower horizontal lines.
Humidity
limitation
ISO 15223-1,
Symbol 5.3.8
IEC 60878 Symbol
2620
ISO 15223-1: Medical devices -
Symbols to be used with
medical device labels, labelling
and information to be supplied
- Part 1: General requirements
IEC 60878: Graphical symbols
for electrical equipment in
medical practice
Indicates the range of
humidity to which the
medical device or its
packaging can be safely
exposed. The humidity
limitation is indicated
adjacent to the upper and
lower horizontal lines.
Atmospheric
pressure
limitation
ISO 15223-1,
Symbol 5.3.9
IEC 60878, Symbol
2621
ISO 15223-1: Medical devices -
Symbols to be used with
medical device labels, labelling
and information to be supplied
- Part 1: General requirements
IEC 60878: Graphical symbols
for electrical equipment in
medical practice
Indicates the range of
atmospheric pressure to
which the medical device or
its packaging can be safely
exposed. The atmospheric
pressure limitations are
shown adjacent to the upper
and lower horizontal lines.

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Packaging Unit
Title of Symbol
Designation /
Reference number
Reference Standards
Description of Symbol
Packaging unit
IEC 60878, Symbol
2794
IEC 60878: Graphical symbols
for electrical equipment in
medical practice
Indicates the number of
pieces in the package.
Mandatory Actions Before Use
Title of Symbol
Designation /
Reference number
Reference Standards
Description of Symbol
Consult
Instructions for
Use
ISO 15223-1,
Symbol 5.4.3
IEC 60878, Symbol
1641
ISO 7000, Symbol
1641
ISO 15223-1: Medical devices -
Symbols to be used with
medical device labels, labelling
and information to be supplied
- Part 1: General requirements
IEC 60878: Graphical symbols
for electrical equipment in
medical practice
ISO 7000: Graphical symbols
for use on equipment
Indicates the need for the
user to consult the
instructions for use. The
operating instructions should
be considered when
operating the device.
Refer to
Instruction
Manual or
Booklet
IEC 60878
Safety Sign
ISO 7010-M002
IEC 60878: Graphical symbols
for electrical equipment in
medical practice
ISO 7010: Graphical symbols –
Safety colors and safety signs –
Registered safety signs
Indicates it is a mandatory
action for the user to refer to
the instruction manual/
booklet prior to use.
Consult
Electronic
Instructions for
Use
ISO 15223-1,
Symbol 5.4.3
ISO 7000, Symbol
3500
ISO 15223-1: Medical devices -
Symbols to be used with
medical device labels, labelling
and information to be supplied
- Part 1: General requirements
ISO 7000: Graphical symbols
for use on equipment
Indicates relevant
information for use of the
product is available in
electronic form rather than,
or in addition to, printed
paper form. The eIFU
indicator is provided as the
manufacturer’s website URL
where the IFU is available in
electronic format.
Caution. Consult
the instructions
for use.
Caution, damage
may result.
ISO 15223-1,
Symbol 5.4.4
ISO 15223-1Medical devices –
Symbols used with medical
device labels, labeling and
information to be supplied –
Part 1: General requirements
Indicates the need to consult
the instructions for use as
damage to the coil may
result.
Indicates the need for the
user to consult the
instructions for use for
important cautionary
information such as warnings
and precautions that cannot,
for a variety of reasons, be
presented on the medical
device itself.
Note
None –Internal
symbol
None –Internal symbol
Notes highlight unusual
points as an aid to a user.

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March 2022
Warning /
Caution
None –Internal
symbol
None –Internal symbol
WARNING indicates a
hazard with a medium
level of risk which, if not
avoided, could result in
death or serious injury.
CAUTION indicates a hazard
with a low level or risk which,
if not avoided, could result in
minor or moderate injury.
Product Identification
Title of Symbol
Designation /
Reference number
Reference Standards
Description of Symbol
Serial number
ISO 15223-1,
Symbol 5.1.7
IEC 60878,
Symbol 2498
ISO 15223-1: Medical devices -
Symbols to be used with
medical device labels, labelling
and information to be supplied
- Part 1: General requirements
IEC 60878: Graphical symbols
for electrical equipment in
medical practice
Indicates the manufacturer’s
serial number so that a
specific medical device can
be identified.
Unique Device
Identifier (UDI)
Code
ISO 15223-1,
Symbol 5.1.10
IEC 60878,
Symbol TBD
ISO 15223-1: Medical devices -
Symbols to be used with
medical device labels, labelling
and information to be supplied
- Part 1: General requirements
IEC 60878: Graphical symbols
for electrical equipment in
medical practice
Indicates the Unique Device
Identification which provides
traceability of the device for
post marketing surveillance.
Catalogue
number
ISO 15223-1,
Symbol 5.1.6
IEC 60878,
Symbol 2493
ISO 15223-1: Medical devices -
Symbols to be used with
medical device labels, labelling
and information to be supplied
- Part 1: General requirements
IEC 60878: Graphical symbols
for electrical equipment in
medical practice
Indicates the manufacturer’s
catalogue number so that the
medical device can be
identified.
Type of MR Coil
Title of Symbol
Designation /
Reference number
Reference Standards
Description of Symbol
RF coil, receive
IEC 60878, Symbol
6193
IEC 60601-2-33,
Table 201.D.102
IEC 60878: Graphical symbols
for electrical equipment in
medical practice
IEC 60601-2-33 Medical
electrical equipment - Part 2-
33: Particular requirements for
the basic safety and essential
performance of magnetic
resonance equipment for
medical diagnosis
Indicates the MR Coil is a
receive only coil.
Do not cross or
loop cables.
Arcing and
patient burns
could result.
None –Internal
symbol
None –Internal symbol
Indicates a warning to staff.
Do not cross or loop cables.
Arcing and patient burns
could result.

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March 2022
Hazard Identification /
Warning Symbols
Title of Symbol
Designation /
Reference number
Reference Standards
Description of Symbol
Magnetic field
strength
None –Internal
symbol
None –Internal symbol
Indicates the magnetic field
strength and the appropriate
strength MR scanner (1.5T or
3.0T) that the medical device
is intended for use with.
Warning: Pinch
point hazard
None –Internal
symbol
None –Internal symbol
Warns user of a closing
motion of mechanical parts
of equipment that may pinch
fingers.
Manufacturer / Country of
Origin
Title of Symbol
Designation /
Reference number
Reference Standards
Description of Symbol
Manufacturer
ISO 15223-1,
Symbol 5.1.1
IEC 60878,
Symbol 3082
ISO 15223-1: Medical devices -
Symbols to be used with
medical device labels, labelling
and information to be supplied
- Part 1: General requirements
IEC 60878: Graphical symbols
for electrical equipment in
medical practice
Indicates the medical device
manufacturer.
Date and
country of
manufacture
ISO 15223-1,
Symbol 5.1.3
IEC 60878,
Symbols 6049
ISO 3166-1
ISO 15223-1: Medical
devices - Symbols to be
used with medical device
labels, labelling and
information to be supplied
- Part 1: General
requirements
IEC 60878: Graphical
symbols for electrical
equipment in medical
practice
Indicates the date when
the medical device was
manufactured. Country of
origin is represented by
the alpha-2 country code
(“CC”) defined in ISO
3166-1.
Country Specific
Requirements
Title of
Symbol
Designation /
Reference
number
Reference Standards
Description of Symbol
Importer
ISO 7000,
Symbol 3725
ISO 7000: Graphical
symbols for use on
equipment
Identifies the entity
importing the medical
device into the locale.
Distributor
ISO 7000,
Symbol 3724
ISO 7000: Graphical
symbols for use on
equipment
Identifies the entity
distributing the medical
device into the locale.
Prescription
Device
21 CFR Part
801.109
21 CFR Part 801.109
Prescription Devices
Indicates: Prescription
Device
Caution: US Federal law
restricts this device to sale
by or on the order of a
clinician.

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March 2022
Medical Device
MDR 2017/745
REGULATION (EU)
2017/745 OF THE
EUROPEAN PARLIAMENT
AND OF THE COUNCIL of 5
April 2017 on medical
devices, amending
Directive 2001/83/EC,
Regulation (EC) No
178/2002 and Regulation
(EC) No 1223/2009 and
repealing Council
Directives 90/385/EEC and
93/42/EEC
Indicates the product is a
medical device.
CE Mark
MDR 2017/745
MDD 93/42/EEC
Annex XII
REGULATION (EU)
2017/745 OF THE
EUROPEAN PARLIAMENT
AND OF THE COUNCIL of 5
April 2017 on medical
devices, amending
Directive 2001/83/EC,
Regulation (EC) No
178/2002 and Regulation
(EC) No 1223/2009 and
repealing Council
Directives 90/385/EEC and
93/42/EEC
Indicates the product
conforms with applicable
requirements set forth in
MDR 2017/745 or MDD
93/42/EEC for conformity
assessment.
Authorized
Representative
in the
European
Community
ISO 15223-1,
Symbol 5.1.2
MDR 2017/745
/ MDD
93/42/EEC
ISO 15223-1: Medical
devices - Symbols to be
used with medical device
labels, labelling and
information to be supplied
- Part 1: General
requirements
REGULATION (EU)
2017/745 OF THE
EUROPEAN PARLIAMENT
AND OF THE COUNCIL of 5
April 2017 on medical
devices, amending
Directive 2001/83/EC,
Regulation (EC) No
178/2002 and Regulation
(EC) No 1223/2009 and
repealing Council
Directives 90/385/EEC and
93/42/EEC
Indicates the Authorized
Representative in the
European Community
Authorized
representative
for Switzerland
Swiss Medical
Devices
Ordinance Art.
51 para. 1
N/A
Indicates the authorized
representative in
Switzerland
Chinese
Environmental
Symbol
SJ/T 11364
equivalent to
2011/65/EU
(EU/RoHS 2)
China RoHS Standard SJ/T
11364: Regulations for the
Labelling of the Use of
Restrained Hazardous
Substances on Electronic
and Electric Products
Indicates Chinese
‘Environmentally Friendly’
Period.

Page 14
March 2022
ETL Listed
Mark
None
N/A
The ETL Listed Mark
indicates that the product
has been tested by
Intertek and found in
compliance with accepted
national standards.
Classification and
Identification of Electrical
Equipment
Title of Symbol
Designation /
Reference
number
Reference Standards
Description of Symbol
Type BF
applied part
ISO 7000, IEC
60417, Symbol
5333
ISO 7000 / IEC 60417:
Graphical Symbols for Use
on Equipment
Indicates the equipment is
a Type BF applied part
which complies with IEC
60601-1.
Class II
equipment
IEC 60878,
Symbol 5172
IEC 60878 - Graphical
symbols for electrical
equipment in medical
practice
Indicates the medical
device equipment meets
the safety requirements
specified for Class II
equipment according to
IEC 61140.
Title of Symbol
Designation /
Reference
number
Reference Standards
Description of Symbol
WEEE; waste
electrical and
electronic
equipment
ISO 7000, IEC
60417, Symbol
6414
Directive 2012/19/EU for
WEEE
ISO 7000 / IEC 60417:
Graphical Symbols for Use
on Equipment
Indicates separate
collection for waste
electric and electronic
equipment (WEEE) is
required.

Page 15
March 2022
3Wrist Array and Accessories
The Wrist Array Coils consist of the following parts. Please inspect upon receipt to make sure all parts
have arrived and are in good condition. Use this guide to refer to part names throughout this manual.
The connector on your coil my look different and the patient comfort pads may be grey.
Description
Part number
Dunlee Order Part number
1
1.5T HD 8ch Wrist Array (Receive only)
5160986-2
4535-300-8344*
HD 8ch Wrist Array (Receive only)
5160986-2
3000-073-1409*
3.0T HD 8ch Wrist Array
5268024-2
4535-302-1916*
HD 8ch Wrist Array
5268024-2
3000-072-9275*
1.5T HD 8ch Wrist Array (Flat Base)
5406395-2
4535-303-1519*
HD 8ch Wrist Array
5406395-2
3000-074-0377*
3.0T HD 8ch Wrist Array (Flat Base)
5406655-2
4535-303-1542*
HD 8ch Wrist Array
5406655-2
3000-074-4656*
1.5T 8ch Wrist Coil, with P-Port Connector
5790142-2
4598-014-1222*
2
Baseplate for curved table**
(Included with coil)
N/A
N/A
2A
Baseplate Riser for flat tabletop** (included with
coil)
N/A
N/A
3
Baseplate (included with coil)
N/A
N/A
4
8ch Wrist Coil Base Pad
See table below for replacement pad kit numbers
5
8ch Wrist Coil Finger Pad
6
8ch Wrist Coil Palm Pad
7
8ch Wrist Coil Upper Pad
8
8ch Wrist Coil Wrist Pad
9
8ch Wrist Coil Elbow Pad
10
1.5T HD 8ch Wrist Array Phantom (only
included with 4535-302-1916*/ 3000-072-9275*)
5160986-5
4535-302-14231

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March 2022
*Represents the revision number
**There will only be one baseplate raiser included with your coil. The riser is determined based on the
MR system table type.
The Wrist Array Coils replacement pads and pad kit numbers are listed in the table below. Please inspect
upon receipt to make sure all parts have arrived and are in good condition.
Description
Part number
Dunlee Order Part
number
Grey Pads
Pad Kit (includes wrist pad, base pad, finger pad,
palm pad, upper pad, elbow pad)
5406395-3
4535-303-03291
Blue Pads
8ch Wrist Coil Base Pad
5160986-7
4535-300-73141
8ch Wrist Coil Finger Pad
5160986-8
4535-300-73151
8ch Wrist Coil Palm Pad
5160986-9
4535-300-73161
8ch Wrist Coil Upper Pad
5160986-10
4535-300-73171
8ch Wrist Coil Wrist Pad
5160986-6
4535-300-73181
8ch Wrist Coil Elbow Pad
5160986-11
4535-300-73191

Page 17
March 2022
4Safety
Training
This manual contains the detailed information regarding the set-up, positioning and use of the Wrist
Array Coils.
Before attempting to operate the coil, you must read these Instructions for Use, noting and strictly
observing all Warnings and Caution notices.
The instructions must be read carefully and thoroughly before attempting to scan patients with this coil.
Precautions
Precautions should be taken when scanning patients with the following conditions:
•Greater than normal potential for cardiac arrest
•An increased likelihood for the developing seizures or claustrophobia
•Unconscious, heavily sedated, or confused patients
•Inability to maintain reliable communications
•*Caution: Federal Law restricts this device to sale, distribution and use by or on the order of a
physician.
Cautions/potential hazards
The following general warning statements apply to scanning with a magnetic resonance system. For
further details, review the warnings in your MR system Operators Manual.
•Assure that the patient is not touching the bore. If necessary, place pads between the patient and the
surface of thebore.
•If the patient complains of 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.
•Patients with implanted ferromagnetic metal should not be scanned because the magnetic field may
interact with implanted surgical clips or other ferromagneticmaterials.
•Persons with cardiac pacemakers or other implanted electronic devices should not enter the magnetic
field zone delineated by the MR systemmanufacturer.
•There is a risk to scanning feverish or decompensated cardiac 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

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March 2022
or near the eye should be carefully screened before undergoing an MR exam.
•Certain transdermal patches may cause burns to the underlying skin due to absorption of RF energy.
The supplier of the patches should be consulted or the patch should be removed to avoid burns. A
new patch should be applied after the examination.
•Patients shall be supervised at all times during scans.
•The use of auxiliary equipment that has not been specifically tested and approved for use in the
environment of the MR equipment may result in burns or other injuries to the patient. Auxiliary
devices labeled as compatible with MR equipment or MR systems may be capable of causing injury if
this operator manual is not followed.
•Equipment not suitable for use in the presence of a flammable anesthetic mixture with air or with
oxygen or nitrousoxide.
The following are coil specific warnings statements
•This Product contains chemicals, including lead, known to the State of California to cause birth
defects or other reproductive harm. Wash hands after handling.
•Warning, Burn Hazard. Remove this coil from the MR System when not plugged in. Failure to do
so may result in injury and/or damage to the coil
•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.
•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.
•Use only approved accessories.
•Do not lift or carry coil by bail (latch).
•Ensure that the patient does not form a loop with any body parts. Do not allow patients to touch any
part of the right hand or arm to any part of the left hand or arm. The loop formed by doing so could
cause an RF burn at the point of contact. Use pads to ensure the patient’s hands do not touch any
metal features of the patient table or cradle. Be sure to educate the patient accordingly and check
the patient’s position immediately before the scan.
Emergency procedures
In the unlikely event that a coil creates smoke, sparks or makes an unusually loud noise, or if the patient
requires emergency assistance:
•Stop the scan if one is inprogress.
•Remove the patient from the scan room if medical treatment is needed.
Technical considerations
•The coil and accessories require special conditions regarding electromagnetic compatibility. The coil

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March 2022
must be installed and used in a shielded scan room provided with the MR magnet and system. The
user must ensure that the scan room door is closed during system use. 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 the operator’s manual.
•The use of accessories other than those specified in the operator’s manual may result in decreased
ESD immunity of the coil or MR system, causing damage to the coil and/or system.
•The equipment should not be used with other coils or equipment present in the MR scanner except
as specified in the Operator’s Manual
•Tampering with the cable pins and connector may damage the connector and affect the coil or
system performance. Please verify that the connector and pins are not damaged before use.
•The coil should not be left unplugged in the system during body coil scanning
•No modification of this equipment is allowed. There are no user serviceable components.
•For split coil designs, the user should avoid touching any exposed connector pins and the patient at
the same time.
•After unpacking the coil, allow it to remain under stable atmospheric conditions for several hours
prior to using. Extreme temperature and/or humidity during storage and/or transportation could
have allowed condensation to form inside the coil.
•At the end of its service life, dispose of the coil in accordance with local regulation.

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March 2022
5Using the Wrist Array Coils
Choosing the best coil position
The Wrist Array Coil is equipped with an at-side coil rail for
imaging at the patient’s side and an over-head coil holder for
imaging over the patient’s head (Superman position). The base
is designed to rest directly on the patient cradle for stability.
Patient size, comfort and scan preference will dictate which
position to use.
To ensure the coil cable will reach the coil port, over-head scans
are performed head-first while at-side scans are performed feet
first.
WARNING: The coil cable must point into the magnet.
Do not loop or cross cable. Arcing and patient burns could
result.
Workflow Imaging with the Wrist at the patient side
*The base plate or table for your system may look slightly different and the coil pads could be a different
color
5.2.1 Positioning the base plate
Position the base plate on the table with the rail on the side of
interest.
Curved Baseplate
5.2.2 Mount the coil on the base plate
For at the side imaging, mount the coil vertically on the base by
sliding the knobs on the sides of the coil into the rail on the
baseplate. Position the coil so that the cable is pointing toward the
magnet end of the table and the coil opens away from the patient
To ensure the coil cable will reach the coil port, at-side imaging is
performed feet first.