MacroMedics EAMIS Lite User manual

MacroMedics BV
Oostbaan 670
2841ML Moordrecht
The Netherlands
[phone]
[email protected]
www.macromedics.com
MANUAL 123110
Instructions for use
English Instructions
MacroMedics ®EAMIS LiteTM
(Extra Accurate Modular Immobilization System)

Manual
Instructions for use EAMIS Lite
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26042021V6IFU123110 MacroMedics ®
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Instructions for use EAMIS Lite
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Table of Contents
1. Warnings 4
2. MRI Safety Information 4
3. Intended Use 5
4. Installation Instructions of the EAMIS Lite 5
5. Cleaning, Storage and Disposal 9
6. Warranty 9
7. Notices 9
8. Glossary of Symbols 10

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1. Warnings
• Inspect the device thoroughly before use. Do not use the device if damaged or if missing parts.
• Check individual components on MR-safety when used together in a patient positioning system.
• Do not use MR unsafe items in an MR environment.
• Place and x the device properly before positioning the patient.
• Rulers on the devices are only intended for reference of the device positioning of accessories. Rulers
shall not replace patient position verication.
• Handle with care to prevent damage.
• Ensure that the baseplate is correctly secured to the couch prior to use.
• In the USA, federal law restricts this device to sale by or on the order of a licensed healthcare
practitioner.
2. MRI Safety Information
2.1 MR UNSAFE
The following devices are MR unsafe:
• 123110 EAMISTM Lite
2.2 MR SAFE
The following devices are MR safe:
• 123860 EAMISTM Lite, MR
• 123400 SBRT Secure Arch, size L
• 123500 SBRT Secure Arch, size M
• 123600 SBRT Secure Arch, size S
• 123700 SBRT Secure Arch, size XS
2.3 MR CONDITIONAL
The following devices are MR conditional:
• All Vacuum Cushions distributed by MacroMedics are MR Conditional.
A patient with this device can be safely scanned in an MR system, meeting the following conditions:
• AStaticMagneticeldof1.5Teslaand3Tesla,with
• Maximumspatialeldgradientof2,500G/cm(25T/m)
• MaximumMRsystemreported,wholebodyaveragedspecicabsorptionrate(SAR)of2W/Kg
(Normal operating mode)
Duetosizeandlocationofthemetallicparts,noclinicallysignicantRFheatingisexpected.

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3. Intended Use
Positioning of the patient during radiotherapy and radiodiagnostics, including MR where indicated.
4. Installation Instructions of the EAMIS Lite
I. PLACE THE COUCHSTRIPS
Place the indexing CouchStrip at the cranial end of the CouchTop.
Place the sliding CouchStrips on caudal end of the CouchTop.
II. PLACE THE EAMIS LITE
Place the EAMIS Lite onto the couchstrips.
Make sure that no movement is possible between the EAMIS and the CouchTop.
III. PLACE THE VACUUM CUSHION
Place a Vacuum Cushion onto the EAMIS Lite before positioning the patient. For the moulding of
a Vacuum Cushion, refer to IFU155100 - Vacuum Cushions.
IV. POSITION THE PATIENT
Position the patient carefully on the Vacuum Cushion.

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V. PLACE THE SBRT SECURE ARCH
Select the appropriate size of SBRT Secure Arch. XS, S, M, L.
Place the brackets carefully over the patient onto the rails of
the EAMIS Lite. Be sure to place the SBRT Secure Arch in the right
direction: see engravings on the SBRT Secure Arch for cranial/
caudal direction.
Rotate and hand-tighten the knobs on each side of the SBRT Secure Arch until the clamps
properly fasten onto the baseplate. Do not apply too much force as this may cause damage.
VI. ATTACHING THE RESPIRATORY SUPPRESSION PLATE TO THE SBRT ARCH
To attach the Respiratory Suppression Plate to the SBRT Secure Arch, slot the white pins of the
Respiratory Suppression Plate into the holes at the top of the SBRT Secure Arch and slide the
white sliding mechanism into the locked position. In the locked position, the arrows (on the
Arch and on the sliding mechanism of the Arch) will be in-line with each other.

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VII. ADJUSTING THE HEIGHT OF THE SBRT SECURE ARCH
Lower the SBRT Secure Arch as appropriate and hand-tighten it in the desired position by
turning the knobs on the sides of the arch. Do not apply too much force as this may cause
damage.
VIII. ADJUSTING THE HEIGHT OF THE RESPIRATORY SUPPRESSION PLATE
To adjust the height of the Respiratory Suppression Plate, press the yellow knob at the side (see
the arrow on the right). Move the Respiratory Suppression Plate vertically into a desired indexed
position. Release the knob to lock the Plate into position.
press/release
G5
G2
G1

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IX. ATTACHING THE ABDOMINAL VACUUM CUSHION
To attach an Abdominal Vacuum Cushion to the SBRT Secure Arch, slot the white pins of the
cushion into the holes at the top of the SBRT Secure Arch and slide the white sliding mechanism
into the locked position. In the locked position, the arrows (on the Arch and on the sliding
mechanism of the Arch) will be in-line with each other.
Slide the two hooks of the Vacuum Cushion over the small white knobs of the Arch. Tighten the
small knobs of the Arch to secure the Vacuum Cushion in place.
To make a vacuum mould, lower the Secure Arch by turning the knobs on the side of the Arch
until the Vacuum Cushion is in tigh contact with the patient.
Care should be taken to keep the cushion valve out of the radiation treatment path.

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5. Cleaning, Storage and Disposal
• Clean the device before and after every use with 70% Isopropanol or soapy water, applied with a
soft cloth. Rinse with water and dry properly. Follow the cleaning precautions provided by the man-
ufacturer of the cleaning agent.
• If unsure about the cleaning uid, do not use it. Never use Ethanol (Ethyl alcohol), aerosol sprays,
corrosive cleaning agents, solvents or abrasive detergents.
• Make sure that there is no residue of the cleaning agent left on the device prior to use.
• The devices are not suitable for sterilization or thermal disinfection.
• Store the device in a clean, ventilated environment.
• Dispose of the device in accordance with the local laws and regulations applicable to your
country.
6. Warranty
The MacroMedics products are warranted to be free from defects in manufacturing, material and
construction. The warranty is for 1 year starting from the date of delivery.
Product warranties remain valid provided the product was installed and/or used according to the
instructions. Defects, malfunctions or failures caused by nature, misuse, abuse and unauthorised
alteration or repair are not warranted.
This warranty is limited to the repair and/or replacement at the sole discretion of MacroMedics.
7. Notices
Any serious incident that has occurred in relation to the device should be reported to the manufacturer
and the competent authority of the Member State in which the user or patient is established.

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8. Glossary of Symbols
Symbol Symbol Name Description of Symbol
European Conformity
EC declaration of conformity by manufacturer.
Manufacturer
Indicates the medical device manufacturer.
Catalogue Number
Indicates the manufacturer’s catalogue number so that the
medical device can be identied.
GS1 Code: (10)
Batch Code
Indicates the manufacturer’s batch code so that the batch or
lot can be identied.
GS1 Code: (21)
Serial Number
Indicates the manufacturer’s serial number so that a specic
medical device can be identied.
Consult Instruction for Use
Indicates the need for the user to consult the instructions for
use.
Caution
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.
Prescription Only
Devices for sale to physicians or trained healthcare providers
only.
MR Safe
An item that poses no known hazards resulting from exposure
to any MR environment. MR Safe items are composed of
materials that are electrically nonconductive, nonmetallic,
and nonmagnetic.
MR Conditional
An item with demonstrated safety in the MR environment
within dened conditions.
MR Unsafe
An item which poses unacceptable risks to the patient,
medical staff or other persons within the MR environment.