Manual Variety Multipurpose Coil - Noras MRI products

Variety 16-Channel Multipurpose Coil 1.5T / 3 T Siemens
Variety 16-Channel
Multipurpose Coil
1.5T/3T Siemens
for Diagnostic Imaging
Operator’s Manual
Revision 04
Date issued: August 2015
Technical changes reserved.
Variety 16-Channel Multipurpose Coil 1.5T / 3T
2
Content
Content
1
General Information ............................................................................. 5
2
Intended Use / Indication for Use ....................................................... 7
2.1
Contraindication ..................................................................................... 7
3
Operating Principle .............................................................................. 8
3.1
Safety Concept ...................................................................................... 8
4
Device Description............................................................................... 9
4.1
4.1.1
Definitions and Symbols ........................................................................ 9
Rating Plates........................................................................................ 11
4.2
System Components............................................................................ 11
4.3
Combination with other Devices........................................................... 12
5
Start-Up ............................................................................................... 13
5.1
General ................................................................................................ 13
5.2
Safety Information ................................................................................ 16
5.3
Preparation of the Coil ......................................................................... 18
5.4
5.4.1
5.4.2
Remove Siemens Spine Coil ............................................................... 20
Avanto / Espree / Trio / Verio ............................................................... 20
Aera / Skyra ......................................................................................... 26
5.5
5.5.1
5.5.2
Positioning of the coil ........................................................................... 31
Diagnostic application fields ................................................................. 32
Arrangement of the coil slots ............................................................... 39
6
Cleaning and Disinfection ................................................................. 41
7
Maintenance, Storage and Waste Disposal ..................................... 46
7.1
Functional Tests................................................................................... 47
7.2
Storage ................................................................................................ 54
7.3
Waste Disposal .................................................................................... 54
8
Technical Specification ..................................................................... 55
8.1
Historical Device Data .......................................................................... 55
8.2
Performance Data ................................................................................ 56
8.3
8.3.1
Parts Lists ............................................................................................ 57
Scope of delivery of the Variety 16-Channel Multipurpose Coil 1.5T
117235 ................................................................................................. 57
Variety 16-Channel Multipurpose Coil 1.5T / 3T
3
Content
8.3.2
Scope of delivery of the Variety 16-Channel Multipurpose Coil 3T
117234 ................................................................................................. 58
8.4
Accessories.......................................................................................... 59
9
Important Addresses ......................................................................... 61
10
Training Outline ................................................................................. 62
Variety 16-Channel Multipurpose Coil 1.5T / 3T
4
General Information
1
General Information
To ensure safe and failure-free operation of this high quality medical device, please
carefully read and follow the instructions of this Operator´s Manual and pay particular
attention to the following information:
The Variety 16-Channel Multipurpose Coil can be used with the following MRI
systems:
117235 Variety 16-Channel Multipurpose Coil Avanto, Espree, Symphony a TIM
1.5T for SIEMENS Scanner:
System, Aera
117234 Variety 16-Channel Multipurpose Coil Trio a TIM System, Verio a TIM
3T for SIEMENS Scanner:
System, Skyra, Prisma
If you would like to receive up-to-date information about the further development or
new accessories for your Variety 16-Channel Multipurpose Coil, please send an email with the serial number of your coil to mri@noras.de.
Prior to using this device for patient examinations, you should complete a training
with the device using a phantom.
The application conditions have a major impact on the life-time of the product. Since
these conditions can vary greatly from user to user, an estimation of life-time from our
point of view is not possible. The most important factors have to be considered are
the frequency of use and the preparation processes (cleaning, disinfection and
sterilization).
Especially for flex coils the frequency of use as well as the type of application (e.g.
bending radius depending on the anatomy to be examined) have major influence on
the life time of the coated printed circuit board inside the foam pad.
It is common with flexible coils that visual marks of use appear while using them
frequently. Visual marks do not have an impact on functionality.
As long as the user takes the intended use into consideration and pays attention to
the warnings and measures specified in the user manual regarding the visual
inspection of all components before each application, there is no significant risk.
Variety 16-Channel Multipurpose Coil 1.5T / 3T
5
General Information
Notice
Please be sure to pay attention to and comply with the
safety information and instructions of the MRI device
manufacturer for operators, patients and third parties.
Prescription use only
Country specific laws restrict this device to sale by or on the
order of a physician, or with the descriptive designation of any
other practitioner licensed by the law of the country in which he
practices to use or order the use of the device.
G15
C32
This device may only be distributed to persons who are licensed
practitioners or to persons who have a prescription or other
order from a licensed practitioner to purchase it.
Device Damage
The coil must not be bent or be stored buckled.
Handling error can cause permanent damages of the device.
C09
Variety 16-Channel Multipurpose Coil 1.5T / 3T
6
Intended Use
2
Intended Use / Indication for Use
The intended use of the Variety 16-Channel Multipurpose Coil 1.5T and 3T is, in
conjunction with a Magnetic Resonance Scanner, body imaging for diagnostic with a
MRI system.
It is indicated for use as a diagnostic imaging device to produce transverse, sagittal,
coronal and oblique images of the internal structures of special regions of the human
body. When interpreted by a trained physician, these images provide information that
can be useful in determining diagnosis.
The outcome of this is diagnostic images of toes, feet, ankle, knee, finger, hand,
wrist, elbow, shoulder, carotid artery, inner ear and other parts of the body with
similar structure can be taken.
2.1
Contraindication
All patient examinations are contraindicated with this system which is also
contraindicated in the proximity of the MRI device according to the information
provided by the manufacturer.
Furthermore, the responsibility lies with the examining physician in case of unclear or
critical clinical picture.
Variety 16-Channel Multipurpose Coil 1.5T / 3T
7
Operating Principle
3
Operating Principle
The Variety 16-Channel Multipurpose Coil described in this document has been
de-signed, depending upon model type, for use with a SIEMENS MRI system with
field strength of 1.5T or 3T. The coil system serves solely as a receiving coil for the
reception of high frequency signals from the hydrogen -(¹-H) nuclei. The hydrogen
nuclei are induced into precession by the transmitting coil of the MRT device. The
processing magnetization induces potential differences in the Variety 16-Channel
Multipurpose Coil which are digitized and further processed in the MRT system.
Thanks to its variable mechanical support system, this coil can be used for a wide
variety of examinations such as the diagnostic imaging of the inner ear, carotid
artery, jaw bone, or, in the orthopedic field, of the finger, wrist, elbow, shoulder, knee,
ankle or toes.
3.1
Safety Concept
The Variety 16-Channel Multipurpose Coil is subject to the same multi-stage safety
concept as for other MRI local coils and has fuses which minimize the patient hazard
as much as possible.
Variety 16-Channel Multipurpose Coil 1.5T / 3T
8
Device Description
4
Device Description
4.1
Definitions and Symbols
The following symbols are used on the Variety 16-Channel Multipurpose Coil or in
the Operator´s Manual.
Variety 16-Channel Multipurpose Coil 1.5T / 3T
ISO 7000-2493
Item Number
ISO 7000-2498
Serial Number
ISO 7000-3082
Manufacturer
ISO 7000-2497
Date of Manufacture
EN ISO 7010M002
Operator’s Manual
Differ to the requirements of EN ISO 701M002 all laser engravings can only be
executed in gray instead of blue due to
technical unfeasibility.
ISO 7000-0434B
Caution,
read
documents
IEC 60417-5172
Protective Insulation
IEC 60417-5333
Type BF
the
accompanying
9
Device Description
Directive
2002/96/EC
ISO 780
Waste products should not be disposed of
with household waste e. g. at a local
authority collection point.
This way up
DIN 55402
ISO 7000-0621
Fragile, handle with care
ISO 7000-0626
Store in a dry place
ISO 7000-0632
Temperature Limit
Conforms with the essential requirements
of Council Directive 93/42/EEC of 14 June
1993 concerning medical devices
Warning regarding risks that may result in
minor physical injury or material damage.
Warning regarding risks that may result in
death or serious physical injury.
Information regarding the optimal use of
the product
On the following page, we describe where you can find our various rating plates on
your product. In addition to the above-described symbols, you will also find the model
designation as well as the product and serial number.
Variety 16-Channel Multipurpose Coil 1.5T / 3T
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Device Description
4.1.1 Rating Plates
The laser engraving is located on one half of the shield trap housing. The term
"16Ch" on the labeling refers to the standard delivery of two identical halves-coils
each half coil includes 8 channels.
4.2
System Components
The Variety 16-Channel Multipurpose Coil consists of the following components:
118398 Variety Positioning Aid Multipurpose
117410 Variety 16-Channel Multipurpose Coil 1.5T
or: 117404 Variety 16-Channel Multipurpose Coil 3T
117407 Operator´s Manual
117542 Velcro Fastener 300
Variety 16-Channel Multipurpose Coil 1.5T / 3T
117981 Variety Clip
118408 Velcro Fastener 500 back to back
117530 Velcro Fastener 500
11
Device Description
4.3 Combination with other Devices
The Variety 16-Channel Multipurpose Coil can be used with the following MRI
systems:
Siemens 1.5T:
Avanto, Espree, Symphony a TIM System, Aera
Siemens 3T:
Trio a Tim System, Verio a Tim System, Skyra, Prisma
Bodily Harm
G30
Also MR-compatible accessories can cause injuries to the
patient and/or the user. Please follow the instructions of the
accessory manufacturer. Non-compliance with these
instructions may lead to injuries of the user and/or patient.
Warning
The Variety 16-Channel Multipurpose Coil may only be used
in combination with those indicated in this Operator‘s Manual
and included devices and coils of NORAS MRI products GmbH
accessories. Use of other accessories is permitted only with
written approval by the NORAS MRI products GmbH.
Variety 16-Channel Multipurpose Coil 1.5T / 3T
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Start-Up
5
Start-Up
5.1
General
The Operator´s Manual must be read by each operator prior to using this device. In
order to become skilled in the proper handling of this system, you should not only
participate in training with the system but also train with a phantom to become
familiar with its use.
Device Damage
Only trained personnel may be assigned to handle the Variety
16-Channel Multipurpose Coil.
G21/G32
Operating errors may cause permanent damages to the device
/ coil.
Device Damage / Coil Error
The users must be trained before using the device (detailed
training of the personnel for existing components).
G22/G37
Bodily Injuries
Only trained personnel may be assigned to handle the Variety
16-Channel Multipurpose Coil.
Operating errors may cause bodily injuries (e.g. contusions) to
the user and/or the patient.
Variety 16-Channel Multipurpose Coil 1.5T / 3T
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Start-Up
Danger of Infection
Prior to start-up of the devices or parts thereof, all components
must be treated as described in chapter 6 “Cleaning and
Disinfection”.
Noncompliance with the above instructions may lead to
infection of the patient.
Bodily harm of the patient
Prior to each use of the coil, injured skin surface must be
covered with sterile drapes.
G10
Note
Please be sure to pay attention to and comply with the
safety information and instructions of the MRI
manufacturer for operators, patients and the third party.
Bodily harm of the patient
Prior to each patient examination, you should make a careful
visual inspection of the system components. Damaged parts
can be sharp-edged and cause injuries to the patient and/or to
the user.
G20
In the case of unusual findings and/or damage found, the
system must not be used. Damaged coils must not be used.
Do not produce images with a defective coil.
Variety 16-Channel Multipurpose Coil 1.5T / 3T
14
Start-Up
Handling
Incorrect handling can cause damage to the coil and to the
connection cable.
G34
The loops of the flexible coil must not be subject to mechanical stress (e.g. by
carrying / lifting the coil or by fixating the coil to the patient´s body using Velcro®
strips).
Variety 16-Channel Multipurpose Coil 1.5T / 3T
15
Start-Up
5.2
Safety Information
While using the Variety 16-Channel Multipurpose Coil please follows the below
safety information:
•
The Variety 16-Channel Multipurpose Coil is not suited for operation in
areas subject to explosive hazards, in the presence of inflammable
anesthetics or combustible gases, such as anesthetics.
•
The Variety 16-Channel Multipurpose Coil has been designed for use with a
MRI device in the special examination room provided for it (climate controlled,
electrically shielded).
•
It may only be used by medical technical personnel who are familiar with the
operating principle of the MRI device and who have been instructed in the
function and use of the Variety 16-Channel Multipurpose Coil by NORAS
MRI products or its responsible company representatives.
•
This coil may only be used in combination with accessories supplied by
NORAS MRI products. You may only use this coil with accessories supplied
by other manufacturers with the express written approval of NORAS MRI
products.
•
Do not use a coil showing visible damage to the housing or its connection cables.
•
The Variety 16-Channel Multipurpose Coil must not be opened by the user.
Improper fixation of the coil
The coil must be fixed properly at the body part under
examination.
G24
Variety 16-Channel Multipurpose Coil 1.5T / 3T
16
Start-Up
Permanent damage of the system
The system may only be assembled by trained medical
personnel.
Incorrect assembly and operator errors made by untrained
personnel can permanently damage individual parts of optional
components and of the device itself.
Variety 16-Channel Multipurpose Coil 1.5T / 3T
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Start-Up
5.3
Preparation of the Coil
Prolongation or termination of the treatment
While plugging in the coil, ensure and check that proper contact
has been made. Check the display of the MRI.
G25
If the coil pair is not properly plugged in, no images can be
produced.
Bodily harm of the patient
Velcro tape may not protrude. Otherwise, it can clamp while
retracting the MR table.
G26
Danger of destruction
The coils must not be cleaned in immersion baths or held under
running water.
G27
Non-respect of the cleaning and disinfection instructions may
cause the destruction of the coils!
Variety 16-Channel Multipurpose Coil 1.5T / 3T
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Start-Up
Device Damage / Coil Error
To remove the plugs, only push on the plug-cover themselves,
do not pull on the plugs or the cables!
Non-respect may cause cable cracks or plug cracks. Defective
coils (this includes cables and plugs) must not be used!
Device Damage / Coil Error
Don´t carry the coils on their cables or plugs. Furthermore,
don´t knot the cables.
G29
Operating errors may cause permanent damages to the device
/ coil.
Use of wrong components
The use of components not listed and described in this
Operator’s Manual, provided by NORAS, is expressly
prohibited.
G36
Variety 16-Channel Multipurpose Coil 1.5T / 3T
19
Start-Up
5.4
Remove Siemens Spine Coil
5.4.1
Avanto / Espree / Trio / Verio
Starting position with Siemens Spine Coil.
Remove the additional cushions at foot and top.
Variety 16-Channel Multipurpose Coil 1.5T / 3T
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Start-Up
Loose the Spine Coil plug on both sides.
Insert the cable connector into the recess of the Spine Coil existing at the foot end.
Variety 16-Channel Multipurpose Coil 1.5T / 3T
21
Start-Up
Remove the Spine Coil from the patient table.
Stable the Spine Coil.
Variety 16-Channel Multipurpose Coil 1.5T / 3T
22
Start-Up
Put the positioning cushions (original Siemens) on the patient table.
Insert the plastic covers (Original Siemens) for head area.
Variety 16-Channel Multipurpose Coil 1.5T / 3T
23
Start-Up
Apply the three-part cushion (original Siemens).
Variety 16-Channel Multipurpose Coil 1.5T / 3T
24
Start-Up
Starting position after remove of the Siemens Spine Coil.
Now, the NORAS customer coils can be connected.
Variety 16-Channel Multipurpose Coil 1.5T / 3T
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Start-Up
5.4.2
Aera / Skyra
Starting position with Siemens Spine Coil.
Remove the additional cushions at foot and top.
Variety 16-Channel Multipurpose Coil 1.5T / 3T
26
Start-Up
Release the Spine Coil by pressing a lock button under the lever in the center of
foot end.
Remove the Spine Coil from the patient table.
Variety 16-Channel Multipurpose Coil 1.5T / 3T
27
Start-Up
Stable the Spine Coil.
Apply the cushions on the MR table (original Siemens).
Variety 16-Channel Multipurpose Coil 1.5T / 3T
28
Start-Up
Insert the foam covers (Original Siemens) for head area.
Apply the three-part cushion (original Siemens).
Starting position after remove of the Siemens Spine Coil.
Now, the NORAS customer coils can be connected.
Variety 16-Channel Multipurpose Coil 1.5T / 3T
29
Start-Up
Connect the two TIM adapter boxes (original Siemens) at the two desired slots.
Variety 16-Channel Multipurpose Coil 1.5T / 3T
30
Start-Up
5.5
Positioning of the coil
The Variety 16-Channel Multipurpose Coil is a multifunctional coil which can be
used for the examination of many different parts of the human body.
It may either be used as a single coil half for example for the wrist, thin elbow, ankle,
surface array, etc. or as combined coil halves for the knee, shoulder, thicker elbow,
ankle, etc.
The coils are fastened on the body by means of Velcro straps.
In addition, the usual positioning aids (foam wedges, cushions, covers, sandbags,
etc.) should be used to support the patient for more comforting.
NORAS MRI products GmbH also offers dedicated positioning aids for specific
anatomies to be used with our Variety 16-Channel Multipurpose Coil.
Following, the application of the coil will be shown exemplary for some individual
body area.
Disinfect the coil surface before and after each patient examination by disinfecting
wipes (only with slightly moist, not wet wipes!). See also Chapter 6 “Cleaning and
Disinfection”!
Variety 16-Channel Multipurpose Coil 1.5T / 3T
31
Start-Up
5.5.1
Diagnostic application fields
5.5.1.1 Knee / Ankle
The dedicated positioning aid is supposed to be used for examination of knee or
ankle. The two coil halves are then to be connected using the two slots on the left
and right side of the MR table (for Aera / Skyra the use of two TIM adapter interfaces
is required).
Variety 16-Channel Multipurpose Coil 1.5T / 3T
32
Start-Up
Positioning of the coil at the magnet by means of the laser sight.
Variety 16-Channel Multipurpose Coil 1.5T / 3T
33
Start-Up
5.5.1.2 Elbow
Plug the coil connector into the TIM adapter box (applies to Aera and Skyra).
For Avanto, Espree, Symphony a TIM, Trio a TIM and Verio a TIM systems the coil
connector can be plugged directly into the slot of the MR table.
Fig. 1
Fig. 2
Fig 3
Fig. 1, 2 and 3: Plug RX Connector TIM
Variety 16-Channel Multipurpose Coil 1.5T / 3T
34
Start-Up
5.5.1.3 Carotid
If you have to use the both halves of the coil simultaneously, please use two TIM
adapter boxes.
Depending on the anatomy the Variety Coil should be fixed to the patient’s body (for
example using the Velcro® strips) as needed it should be stabilized using sandbags.
Depending on the individual anatomy the patient should be positioned comfortably by
means of support aids (cushion, wedges, sand bags, etc.)
Please note that the cable do not cross each other or form loops.
Variety 16-Channel Multipurpose Coil 1.5T / 3T
35
Start-Up
5.5.1.4 Hand / Wrist
Variety 16-Channel Multipurpose Coil 1.5T / 3T
36
Start-Up
Positioning of the coil at the magnet by
means of the laser sight.
Variety 16-Channel Multipurpose Coil 1.5T / 3T
The laser sight has to be aligned with the
center of the coil.
37
Start-Up
5.5.1.5 Shoulder
An additional sandbag on the coil contributes to more stabilization.
Variety 16-Channel Multipurpose Coil 1.5T / 3T
38
Start-Up
5.5.2
Arrangement of the coil slots
The coil slots are arranged at the foot and head end of the patient table.
Patient table with slots arrangements:
(1)
slot 1:
8 channels
(2)
slot 2:
4 channels
(3)
slot 3:
6 channels
(4)
slot 4:
8 channels
(5)
slot 5:
4 channels
(6)
slot 6:
6 channels
(7)
slot 7:
6 channels
(8)
slot 8:
8 channels
Variety 16-Channel Multipurpose Coil 1.5T / 3T
39
Start-Up
(9)
slot 9:
6 channels
(10)
slot 10:
8 channels
Correct connection of the coil
Please pay attention to select the correct coil slots. The 8-channel
coils should only be plugged into slots 1, 4, 8 and 10.
Variety 16-Channel Multipurpose Coil 1.5T / 3T
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Cleaning and Disinfection
6
Cleaning and Disinfection
WARNINGS:
The instructions must be followed as described.
In case of inadequate cleaning or disinfection, you have to
carry the risk of infection. Non-respect of the disinfection
instructions may cause the destruction of the coils.
Non-compliance with the cleaning instructions may destroy the
system. No warranty service will be provided for damages due
to improper disinfecting.
Please always wear protective gloves and carefully comply
with the application times for Hepatitis B and HI viruses (See
the instructions for use of the respective disinfectant solution).
Limitations on Frequent processing can have an impact on these products
reprocessing:
(color changes), but do not affect the function of the product.
Spare parts can be purchased from NORAS MRI products
GmbH.
Danger of infection
Prior to start-up of the devices or parts thereof, all components
must be treated as described in chapter ‘Cleaning and
Disinfection’.
Non-compliance with the above instructions may lead to
infection of the patient.
Variety 16-Channel Multipurpose Coil 1.5T / 3T
41
Cleaning and Disinfection
Hygiene
Despite the prescribed wipe disinfection, we recommend for a
double safety to insert a sterile MR-compatible drape between
the coil and the skin surface.
Generally, the user is responsible for hygiene.
Note
Please always wear protective gloves and comply with the
application times for Hepatitis B and HI viruses (See the
instructions for use of the respective disinfectant solution).
INSTRUCTIONS
Point of Use:
Individual Parts
Remove excess soil with disposable cloth
/ paper wipe.
Containment and No particular requirements. It is reTransportation: commended to reprocess the product as
soon as possible after its use. The
products should be transported in a closed
container.
Preparation
Cleaning:
for No particular requirements.
Variety 16-Channel Multipurpose Coil 1.5T / 3T
42
Cleaning and Disinfection
Cleaning
and Equipment:
Only for:
Disinfection:
Disinfectant:
Example Sekusept® Coil surface, Coil
Manual:
PLUS (Ecolab) 4.0 vol %, Korsolex® cable
The Variety 16- Plus 3.0 vol % with exposure time of 15
Channel
minutes. For this purpose all aldehydeMultipurpose
free surface disinfectants, which have
Coil may not be been approved and released by the
cleaned
in Robert Koch Institute (RKI), can be used
immersion baths in accordance with the instructions on the
and may not be label.
held
under
The solution is to be distributed on the
running water.
surfaces by a lint free cloth. The
disinfectant permeates the dirt particles
and due to mechanical forces (pressure,
Only
wipe abrasion), this ensures effective cleaning.
disinfection
is Additionally, the wiping motion ensures
allowed.
that the spores, which are resistant to the
disinfectant, will be removed. The cloth
must be replaced after the disinfection in
order to prevent the spreading of the
spores on other areas. Moreover, it is
essential that the wiping solution is
renewed regularly.
Variety 16-Channel Multipurpose Coil 1.5T / 3T
43
Cleaning and Disinfection
Danger of Destruction
The coils must not be cleaned in immersion baths or held
under running water.
Non-respect of the cleaning instructions may cause the
destruction of the coils!
Danger of Destruction
The coils must not be cleaned in immersion baths.
G33
Non-respect of the disinfection instructions may cause the
destruction of the coils!
Danger of Destruction
Non-respect of the disinfection instructions may cause the
destruction of the coils!
G13
No warranty service will be provided for damages due to
improper disinfection. Improper disinfection may result in
malfunction of the device.
Danger of Destruction
Non-respect of the cleaning instructions may cause the
destruction of the coils!
No warranty service will be provided for damages due to
improper cleaning. Improper cleaning may result in malfunction
of the device.
Variety 16-Channel Multipurpose Coil 1.5T / 3T
44
Cleaning and Disinfection
Maintenance, Inspection Damaged parts should be discarded.
and Testing:
All parts: Visually inspect for damage and wear.
Storage:
Safe, dry, dust-free and protected from light.
Constant temperature {min.50 F (10°C) / max. 86 F
(30°C)}
Constant air humidity (min. 10% / max. 95%)
Manufacturer Contact:
Variety 16-Channel Multipurpose Coil 1.5T / 3T
See Chapter 9
45
Maintenance, Storage and Waste Disposal
7
Maintenance, Storage and Waste Disposal
Prior to each use, all components of the Variety 16-Channel Multipurpose Coil
must be visually inspected.
Pad coil
Check for breaks and cracks
Cable and Plug
Defective products must not be used. In such a case, please contact NORAS MRI
products GmbH.
Comply with the cleaning and disinfection instructions!
We recommend that you have a single channel test of the coils performed on a
monthly basis using the specified test program of the MRI system.
Injury of the patient
Prior to each patient examination, a visual inspection of all
components is mandatory.
G20
In case of unusual findings and /or damage, the coil must not
be used. Damaged parts can be sharp-edged and can cause
injuries to the patient and/or the user. Do not use damaged
coils and do not produce images with a defective coil.
Variety 16-Channel Multipurpose Coil 1.5T / 3T
46
Maintenance, Storage and Waste Disposal
7.1
Functional Tests
In case that coil malfunctions are suspected, the operator may perform the functional
test described below.
Initially, place one coil half in the support cushion.
Fixate the coil tightly around the standard Siemens 2000ml phantom bottle by using a
Velcro® strip (see picture below).
Prior to starting the functional test the coil connector has to be plugged in.
Variety 16-Channel Multipurpose Coil 1.5T / 3T
47
Maintenance, Storage and Waste Disposal
To prepare for the measurement, first align the laser sight on the bottles centrally and
transport the coil into the ISO center.
The following measurements have to be performed for both coil halves.
Variety 16-Channel Multipurpose Coil 1.5T / 3T
48
Maintenance, Storage and Waste Disposal
Take a normal localizer sequence measurement.
Subsequently, a slice of the standard Siemens “sn” measuring sequence is placed
centrally in the phantom bottle in coronal direction. For a better understanding: The
coil half is hereby located underneath the phantom bottle shown in the first MR
image.
Variety 16-Channel Multipurpose Coil 1.5T / 3T
49
Maintenance, Storage and Waste Disposal
This sequence can be found as following:
„Siemens/SequenceRegion/ServiceSequences/DefaultProtocols/sn“
Sequence:
Siemens/SequenceRegion/ServiceSequences/DefaultProtocols/sn
Variety 16-Channel Multipurpose Coil 1.5T / 3T
50
Maintenance, Storage and Waste Disposal
Select the function „save uncombined“.
Save uncombined
Furthermore, the coil elements must be selected in the coil options:
Variety 16-Channel Multipurpose Coil 1.5T / 3T
51
Maintenance, Storage and Waste Disposal
Now, you can start the measurement.
If the signal of each channel is shown, approximately the following result should arise
for each coil half.
The illustration shows that all 8 channels of the coil half receive reasonable signal.
Variety 16-Channel Multipurpose Coil 1.5T / 3T
52
Maintenance, Storage and Waste Disposal
This picture shows the combined signal from all 8 channels of one coil half.
If the images produced during your measurement appear significantly different from
the above (e.g. the image contains band or one channel with a clearly weaker signal,
then a coil may be defective. In this case, please contact the NORAS MRI products
GmbH.
Variety 16-Channel Multipurpose Coil 1.5T / 3T
53
Maintenance, Storage and Waste Disposal
7.2
Storage
When the Variety 16-Channel Multipurpose Coil is not in use, we recommend that
it be stored on the shelves provided for this purpose in MRT room.
After use, the device should be stored dry and at room temperature
{min. 50 F (10°C), max. 86 F (30°C)} in a dust-free, UV radiationprotected location.
•
Relative Humidity: Min.10%, Max. 95%
•
Air Pressure: Min. 500 hPa, Max.1060 hPa
Destruction
The coil must not be bent or be stored buckled, otherwise it can
lead to coil loop breaking.
7.3
Waste Disposal
All of the materials used in the production of the system components can be
conveniently recycled and therefore do not present any particular or unusual hazards
during their disposal.
Prior to disposal, the system must be disinfected as described above to eliminate any
risk of infection.
Disposal of Variety 16-Channel Multipurpose Coil: are to be handed back to the
manufacturer.
We would be happy to provide you with additional information about disposal upon
request.
Variety 16-Channel Multipurpose Coil 1.5T / 3T
54
Technical Specification
8
Technical Specification
8.1
Historical Device Data
Designation (Model/Type)
Product Type / Device Type (according
to UMDNS / DIMDI)
Variety 16-Channel Multipurpose Coil
1.5T
Surface Coil, MR (17-542)
Variety 16-Channel Multipurpose Coil
3T
Manufacturer:
Supplier:
NORAS MRI products GmbH
NORAS MRI products GmbH
Leibnizstrasse 4
Leibnizstrasse 4
97204 Hoechberg
97204 Hoechberg
Germany
Germany
Operation Type
Test / Control (Time Limits / Type)
active
non-active
Product Class / Device Class
Intended Use according to information
provided by the Manufacturer:
IIa (MDD Annex IX, Chapter III,
Clause 3, Paragraph 3.2, Rule 10)
2 x 8-channel coil system for diagnostic
imaging in MRT
Identification no. of Notified Body
Serial Number
(
1001 incremental
-Marking):
0123
Variety 16-Channel Multipurpose Coil 1.5T / 3T
55
Technical Specification
8.2
Performance Data
Operating Temperature
Corresponding with the air-conditioned
room temperature of the MRI room
Storage Temperature
See 7.3
Protection Class
II
Weight
950 g
Dimensions
Width: approx. 220 mm
Height: approx. 35 mm
Depth: approx. 200 mm
1.5 T: 63.6 MHz
Resonance frequency
3 T:
Interfaces:
123.2 MHz
Electrical: SIEMENS MRT
Mechanical: MRT-Patient Table
Maximum Operating Time of Coils:
Continuous operation
Field of view (maximal):
200 mm x 220 mm x 110 mm
Variety 16-Channel Multipurpose Coil 1.5T / 3T
56
Technical Specification
8.3
Parts Lists
8.3.1
Scope of delivery of the Variety 16-Channel Multipurpose Coil 1.5T
117235
Description
Part Number
Quantity
Variety 16-Channel Multipurpose
Coil 1.5T
117410
2
Variety
Positioning
Multipurpose
118398
2
Velcro Fastener 500 back-to-back
118408
4
Velcro Fastener 300
117542
4
Velcro Fastener 500
117530
4
Variety Clip
117981
2
Operator’s Manual
117407
1
Packaging
117757
1
Aid
118398 Variety Positioning Aid Multipurpose
117410 Variety 16-Channel Multipurpose Coil 1.5T
117407 Operator´s Manual
117542 Velcro Fastener 300
Variety 16-Channel Multipurpose Coil 1.5T / 3T
117981 Variety Clip
118408 Velcro Fastener 500 back to back
117530 Velcro Fastener 500
57
Technical Specification
8.3.2
Scope of delivery of the Variety 16-Channel Multipurpose Coil 3T
117234
Description
Part Number
Quantity
Variety 16-Channel Multipurpose
Coil 3T
117404
2
Variety
Positioning
Multipurpose
118398
2
Velcro Fastener 500 back-to-back
118408
4
Velcro Fastener 300
117542
4
Velcro Fastener 500
117530
4
Variety Clip
117981
2
Operator’s Manual
117407
1
Packaging
117757
1
Aid
118398 Variety Positioning Aid Multipurpose
117404 Variety 16-Channel Multipurpose Coil 3T
117407 Operator´s Manual
117542 Velcro Fastener 300
Variety 16-Channel Multipurpose Coil 1.5T / 3T
117981 Variety Clip
118408 Velcro Fastener 500 back to back
117530 Velcro Fastener 500
58
Technical Specification
8.4
Accessories
Description
Part Number
Positioning Aid Knee-Feet
118463
Positioning Aid Shoulder
118413
Positioning Aid Elbow
118468
Positioning Aid Pediatrics small
118465
Variety 16-Channel Multipurpose Coil 1.5T / 3T
Illustration
59
Technical Specification
Description
Positioning
medium
Aid
Part Number
Pediatrics
118467
Positioning Aid Pediatrics large
118412
Positioning Aid Inlay
118415
Positioning Aid Multipurpose
118398
Variety 16-Channel Multipurpose Coil 1.5T / 3T
Illustration
60
Important Addresses
9
Important Addresses
Manufacturer (Development and Production)
NORAS MRI products GmbH
Leibnizstrasse 4
97204 Hoechberg / Germany
Phone: +49 (0)931/2 99 27-0
Fax: +49 (0)931/2 99 27-20
E-Mail: mri@noras.de
Web: www.noras.de
Variety 16-Channel Multipurpose Coil 1.5T / 3T
61
Training Outline
10
Training Outline
I have reviewed the Variety 16-Channel Multipurpose Coil Training Outline and
understand the topics discussed, and verify that the training outlined is complete.
The training delivered was reflective of the details in the Variety 16-Channel
Multipurpose Coil user manual. I will read (or have read) this appropriate manual,
including the Cleaning and Disinfecting section of the manual.
I understand
the intended use and the functionality of the Variety 16-Channel
Multipurpose Coil
☐
and I am aware of the components of Variety 16-Channel Multipurpose
Coil
☐
the installation of the Variety 16-Channel Multipurpose Coil
☐
the complete setup of the Variety 16-Channel Multipurpose Coil
☐
the application on patients
☐
the cleaning instructions
☐
the disinfection instructions
☐
that it is NOT NORAS’ responsibility for timely replacement of worn out
parts
☐
Variety 16-Channel Multipurpose Coil 1.5T / 3T
62
Training Outline
Title
Name
Department
Date & Signature:
E-Mail Adress:
☐ Contact Person
Phone No.:
Customer:
Trained by:
NORAS Application Trainer
Date & Signature:
Quality System Document
It is the responsibility of the user to verify this document originated from the controlled master and is the active revision prior to use. This document contains
confidential or proprietary information of NORAS MRI products GmbH. Neither the document nor the information therein is to be reproduced, distributed, used
or disclosed, either in whole or in part, except as specifically authorized by NORAS MRI products GmbH.
Variety 16-Channel Multipurpose Coil 1.5T / 3T
63
Notes
Variety 16-Channel Multipurpose Coil 1.5T / 3T
64
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