Invivo dS HiRes Hand/Wrist 16ch 1.5T User manual

dS HiRes Hand/Wrist 16ch coil
Instructions for Use
dS HiRes Hand/Wrist 16ch 1.5T
dS HiRes Hand/Wrist 16ch 3.0T
Invivo Corporation
3545 SW 47th Avenue
Gainesville, FL 32608-7691 USA
Phone: [phone]
invivo.service_and_accesso[email protected]
www.philips.com/healthcare
300008312591

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Instructions for Use dS HiRes Hand/Wrist 16ch
Revision A, 10/2021
Licenses and Trademarks
© 2021 Invivo Corporation
Invivo Corporation 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
Invivo Corporation to provide accurate and up-to-date information to users.
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 Philips 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.philips.com/IFU
Philips Medical Systems Nederland B.V.
Veenpluis 6
5684 PC Best
The Netherlands
Australian Sponsor
Philips Electronics Australia Ltd
65 Epping Road, North Ryde, NSW,
Australia 2113

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Table of Contents
1 Introduction ...................................................................................................................................... 5
Safety Awareness ...................................................................................................................... 5
Residual risks ............................................................................................................................. 5
Device Description .................................................................................................................... 5
1.3.1 Coil Dimensions ................................................................................................................. 7
Indications for use ..................................................................................................................... 7
Contraindications ...................................................................................................................... 7
Target patient groups ............................................................................................................... 7
Intended users .......................................................................................................................... 7
Clinical benefits and undesirable side effects ........................................................................... 7
Basic Operating Principles ......................................................................................................... 8
Compatibility ............................................................................................................................. 8
2 Explanation of Symbols ..................................................................................................................... 9
3 Safety .............................................................................................................................................. 16
Training ................................................................................................................................... 16
Precautions ............................................................................................................................. 16
Cautions and Warnings ........................................................................................................... 16
Emergency procedures ........................................................................................................... 17
Technical considerations ......................................................................................................... 17
EMC Information ..................................................................................................................... 18
Ambient operating conditions ................................................................................................ 19
4 Product End of Life .......................................................................................................................... 20
5 dS HiRes Hand/Wrist 16ch Coil and Accessories ............................................................................ 21
6 Using the dS HiRes Hand/Wrist 16ch coils ...................................................................................... 22
Workflow for overhead examination ...................................................................................... 23
Patient hearing protection ...................................................................................................... 26
After scanning ......................................................................................................................... 26
Workflow for hand at the patient’s side examination ............................................................ 27
Patient hearing protection ...................................................................................................... 30
After scanning ......................................................................................................................... 30
7 Scanning .......................................................................................................................................... 32

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Scan protocols ......................................................................................................................... 32
8 Cleaning and disinfection ................................................................................................................ 33
Cleaning ................................................................................................................................... 33
Disinfection .............................................................................................................................. 33
Spaulding classification ............................................................................................................ 34
Recommended cleaning agents .............................................................................................. 34
Recommended disinfection agents ......................................................................................... 34
9 Prevention ....................................................................................................................................... 35
Preventing residue on MR coil ................................................................................................ 35
Cleaning and disinfection frequency ....................................................................................... 35
10 Cleaning and disinfecting procedure ........................................................................................... 36
Inspection ................................................................................................................................ 36
General cleaning instructions .................................................................................................. 36
Disinfecting instructions .......................................................................................................... 36
11 Installation and maintenance ...................................................................................................... 38
Installation and configuration ................................................................................................. 38
Quality assurance .................................................................................................................... 38
12 Complaints ................................................................................................................................... 39

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1 Introduction
This manual describes the features, use and care of the dS HiRes Hand/Wrist 16ch 1.5T and
3.0T coil for use with a Philips Ingenia MRI System. All coils shall be referred to as dS HiRes
Hand/Wrist 16ch coils for the rest of this document. The dS HiRes Hand/Wrist 16ch coils are
receive only coils. Please review the manual thoroughly before using the device.
Safety Awareness
Do not use this coil unless you have read, fully understand and know all the safety
information and emergency procedures given in the SAFETY section of this Instructions for
Use. Operation of the product without proper awareness of how to use it safely could lead to
patient or user injury. It could also lead to clinical misdiagnosis.
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.
Residual risks
To ensure that a procedure is safely performed, and for the complete set of contraindications,
warnings and precautions, please follow this instruction, and the MR system instructions for use
(a separate publication provided with the MR system).
Device Description
The dS HiRes Hand/Wrist 16Ch coil is a 16-element receive only coil, which can be used
independently (Figure 9). The dS HiRes Hand/Wrist 16Ch coil is designed to visualize the thin
cartilage layers and the interosseous ligaments of the hand and wrist. The coil can be used
vertically at the patient’s side or horizontally overhead, connected to a rigid base plate for
fixation to reduce patient motion.
The coil is used independently and cannot be combined with any other coils. The coils are
available in both 1.5T and 3.0T.

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Instructions for Use dS HiRes Hand/Wrist 16ch
Figure 1. dS HiRes Hand/Wrist 16ch
Type of coil  16 channel phased-array coil
 Receive-only
Design Rigid volume coils that closely encircle the hand/wrist for high Signal to Noise Ratio.
One-piece, hinged design for easy patient set-up. To reduce patient motion artifacts,
the dS HiRes Hand/Wrist 16ch coil includes a rigid base plate with two positions to
fixate the
coil:
one for overhead and one for at
the side examinations.
Available for On the sticker on the coil, you see the MRI system type and field strength your coil is
suited for.
dS-SENSE-compatible Yes
CLEAR-compatible Yes
MultiTransmit-
compatible
No
Applications High resolution wrist and hand imaging.
General remarks  Do not combine this coil with other coils.
 The coil can be used at the patient’s side, with the joint vertically, and over-
head with the joint horizontally.
dStream Interface Required
Connector dStream socket/connector on the dStream Interface

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1.3.1 Coil Dimensions
The dS HiRes Hand/Wrist 16ch MR Coil (excluding cable) dimensions are:
Dimension Cm Inches
Height 14.78 5.82
Width 22.99 9.05
Length 40.89 16.10
The dS HiRes Hand/Wrist 16ch MR Coil base plate dimensions are:
Dimension Cm Inches
Height 5.08 2.00
Width 50.06 19.71
Length 42.95 16.91
Indications for use
The dS HiRes Hand/Wrist 16ch 1.5T and 3.0T MR Coils are intended to be used in conjunction with
Philips 1.5T/3.0T Magnetic Resonance Scanners to produce diagnostic images of the hand and wrist
anatomy that can be interpreted by a trained physician.
Contraindications
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.
Target patient groups
The target population for the device is any patients scheduled for MRI exam of the wrist and hand.
The surface materials of the coil may be in contact with the patient’s skin with limited exposure
(<24h).
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

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Instructions for Use dS HiRes Hand/Wrist 16ch
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, 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 (a separate publication) for any undesirable side effects
related to the use of MR scanners.
Basic Operating Principles
This radiofrequency coil is designed for use with Philips 1.5T and 3.0T Ingenia MRI scanners. The coil
receives magnetic resonance signals generated in hydrogen nuclei (protons) in the human body while
blocking the high-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. Images can be acquired in any plane.
Compatibility
The dS HiRes Hand/Wrist 16ch 1.5T MR coil is compatible with Philips Ingenia MRI 1.5T Scanners with
a dStream interface.
The dS HiRes Hand/Wrist 16ch 3.0T MR coil is compatible with Philips Ingenia MRI 3.0T Scanners with
a dStream interface.

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2 Explanation 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
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

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Instructions for Use dS HiRes Hand/Wrist 16ch
IEC 60878: Graphical symbols
for electrical equipment in
medical practice
and lower horizontal lines.
Mandatory
Actions Before
Use
Title of Symbol
Designation /
Reference
number
Reference Standards Description of Symbol
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 colours 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, labelling 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.
Warning /
Caution
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.

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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.
Product
Identification Title of Symbol
Designation /
Reference
number
Reference Standards Description of Symbol
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: Requirements for the
basic safety and essential
performance of magnetic
resonance equipment for
medical diagnosis
Indicates the MR Coil is a
receive only coil.

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Instructions for Use dS HiRes Hand/Wrist 16ch
Prohibitions Title of Symbol
Designation /
Reference
number
Reference Standards Description of Symbol
Do not cross
or loop cables.
Arcing and
patient burns
could result.
None – Internal
symbol
Indicates a warning to staff.
Do not cross or loop cables.
Arcing and patient burns
could result.
Hazard
Identification /
Warning Symbols
Title of Symbol
Designation /
Reference
number
Reference Standards Description of Symbol
Magnetic field
strength
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
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.
Manufacturer /
Country of Origin Title of Symbol
Designation /
Reference
number
Reference Standards Description of Symbol
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.

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Country Specific
Requirements Title of Symbol
Designation /
Reference
number
Reference Standards Description of Symbol
Importer
ISO 15223-1,
Symbol 5.1.8
IEC 60878,
Symbols 3725
ISO 7000,
Symbol 3725
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
Identifies the entity importing
the medical device into the
locale.
Distributor
ISO 15223-1,
Symbol 5.1.9
IEC 60878,
Symbols 3724
ISO 7000,
Symbol 3724
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
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.
Medical
Device
ISO 15223-1,
Symbol 5.7.7
IEC 60878,
Symbols TBD
MDR 2017/745
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
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
Indicates the product
conforms with applicable
requirements set forth in
MDR 2017/745 or MDD
93/42/EEC for conformity

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Instructions for Use dS HiRes Hand/Wrist 16ch
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
assessment.
Country Specific
Requirements Title of Symbol
Designation /
Reference
number
Reference Standards Description of Symbol
Authorized
Representativ
e 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
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.
ETL Listed
Mark None
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
Indicates separate collection
for waste electric and
electronic equipment (WEEE)
is required.

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Equipment
CAUTION: US Federal law restricts this device to the sale, distribution and
use by or on the order of a physician.

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Instructions for Use dS HiRes Hand/Wrist 16ch
3 Safety
Training
This manual contains the detailed information regarding the set-up, positioning and use of the dS
HiRes Hand/Wrist 16ch MR coil is compatible with Philips Ingenia MRI Scanners with a dStream
interface.
Before attempting to operate the coil, you must read these Instructions for Use, noting and strictly
observing all Warnings and Caution notices.
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
Cautions and Warnings
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 (a separate publication).
 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.
 Remove unconnected receive coils and electric cables from the RF transmit coil during the
examination. Patient burns could result.
 Avoid direct contact of the patient’s skin with the coil and cable surfaces, patient burns could
result. Use pads between the patient and coil and cable surfaces.
 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 medical devices/components should not be scanned because the
magnetic field may interact with the medical device/component. Consult patient’s physician.
 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 decompensated cardiac patients.
 Do not allow the patient to bring magnetic objects or non-magnetic metallic objects – such as
jewelry, hairpins, prosthetics, or clothing containing metal components – into the magnet.
Such objects will interfere with the imaging capabilities of the system and coil.
 Certain transdermal patches may cause burns to the underlying skin due to absorption of RF

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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.
 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, housings and connector boxes
before each use. If the insulation or housing is broken, or if the cable is frayed, immediately
discontinue use of the device.
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 in progress.
 Remove the patient from the scan room if medical treatment is needed.
Technical considerations
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.
No modification of this equipment is allowed. There are no user serviceable components and is not
user repairable.
The coil should only be used with the cable and accessories specified in the system operator manual.
The use of accessories other than those specified in the system operator 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 system operator manual.
Tampering with the cable pins and connector may damage the connector and affect coil or system
performance. Please verify that connector and pins are not damaged before use.
The coil should not be left unplugged in the system during body coil scanning.
Reference the MR system or supplied application guide for coil positioning requirements, specific
operating conditions, and routine maintenance.
At the end of its service life, dispose of the coil in accordance with local regulation.
User should avoid touching any exposed connector pins and the patient at the same time.
Users must be trained on the safe and effective use of the MRI scanner before attempting to operate
the coil.

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Instructions for Use dS HiRes Hand/Wrist 16ch
EMC Information
Guidance and manufacturer’s declaration – electromagnetic emissions:
The dS HiRes Hand/Wrist 16ch MR coil is compatible with Philips Ingenia MRI Scanners with a dStream
interface. The MR coil is intended for use in the electromagnetic environment specified below. The
customer or the user of the coil should ensure that it is used in such an environment.
Emission test Compliance Electromagnetic environment - guidance
RF emissions CISPR 11 Group 1 The dS HiRes Hand/Wrist 16ch Coil uses RF
energy only for its internal function. There
for its RF emissions are very low and are
not likely to cause any interference in
nearby electronic equipment.
RF emissions CISPR 11 Class A The dS HiRes Hand/Wrist 16ch Coil and MR
system is suitable for use in all
establishments other than domestic
establishments and those directly
connected to the public low-voltage power
supply network that supplies buildings
used for domestic purposes.
Harmonic emissions
IEC 61000-3-2
Not applicable Not applicable
Voltage
fluctuation/flicker
emissions IEC 61000-3-
3
Not applicable Not applicable
Note It is mandatory for the actual RF shielding effectiveness and the filter attenuation in the shielded
location to be verified and to ensure that the actual values meet or exceed the specified minimum
values.
Cables or options other than those used for the current product must not be used. If cables or options
other than those used for the current product are used, the EMI performance may deteriorate.

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Immunity test IEC 60601 test
level Compliance level Electromagnetic environment - guidance
Electrostatic discharge
(ESD)
IEC 61000-4-2
±8 kV contact
±15 kV air
±8 kV contact
±15 kV air
Floors should be of wood,
concrete, or ceramic tile. If
floors are covered with
synthetic material, the relative
humidity should be at least
30%
Electrical fast
transient/burst IEC
61000-4-4
± 2 kV for power
supply lines
± 1 kV for input/
output lines
Not applicable Not applicable
Surge
IEC 61000-4-5
± 1 kV line(s) to
line(s)
± 2 kV line(s) to
earth
Not applicable Not applicable
Power frequency
(50/60Hz) magnetic
fields
IEC 61000-4-8
3 A/m Not applicable Not applicable
Short interruption on
power supply line IEC
61000-4-11
<5% U for 5
seconds
Not applicable Not applicable
Ambient operating conditions
Symbol Measurement Type Operating Conditions
Humidity 40 to 70% non-condensing
Temperature 18-22o C (64-72o F)

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Instructions for Use dS HiRes Hand/Wrist 16ch
4 Product End of Life
The functional life and proper performance of coils are guaranteed only while the coil is being used on
the MR system hardware specified at the time of purchase. Upgrades or other modifications to the
system may affect compatibility.
During ongoing use of the coils, immediately discontinue use of this device if the following symptoms
of age appear:
Frayed Cable - If the insulation or housing is broken, or if the cable is frayed, immediately discontinue
use of the device.
Damaged connector and pins - damaged cable pins and connector may damage the connector and
affect coil or system performance.
Cracked coil casing – cracked coil casings can expose electrical components, rendering the coil unsafe
for the patient and/or user.