MacroMedics LEX-Ultra User manual

MacroMedics BV
Oostbaan 670
2841ML Moordrecht
The Netherlands
[phone]
[email protected]
www.macromedics.com
MANUAL 132100
Instructions for use
English Instructions
MacroMedics ®LEX-Ultra

Manual
Instructions for use LEX-Ultra
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26042021V7IFU132100 MacroMedics ®
Table of Contents
1. Warnings 3
2. MRI Safety Information 3
3. Intended Use 3
4. Installation Instructions 4
5. Cleaning, Storage and Disposal 6
6. Warranty 6
7. Notices 6
8. Glossary of Symbols 7

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Instructions for use LEX-Ultra
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26042021V7IFU132100 MacroMedics ®
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.
• Secure the device properly before positioning the patient.
• 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:
• 132100 LEX Ultra
2.2 MR SAFE
The following devices are MR safe:
• 132150 LEX-Ultra MR
3. Intended Use
Positioning of the patient during radiotherapy and radiodiagnostics, including MR where indicated.

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26042021V7IFU132100 MacroMedics ®
4. Installation Instructions
4.1 PLACE THE COUCHSTRIPS
Place the indexing CouchStrip at the cranial end of the CouchTop.
Place the sliding CouchStrip at the caudal end of the CouchTop.
 Optional:ScrewthexedCouchStripsontothedevice
using 2x Countersunk M6x20 Polyamide screws.
4.2 PLACE THE LEX-ULTRA
Carefully align the LEX-Ultra with the CouchStrips and gently slot into place.
4.3 CHANGING THE TILTING POSITION OF THE LEG SUPPORT
Open the locking mechanism by pulling the coverplate towards caudal direction, allowing the
pins of the leg supports to fall into the indents in the base.
CRANIAL
Coverplates: pull to unlock
CAUDAL

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4.4 LOCKING THE LEG SUPPORTS IN THE CORRECT POSITION
Close the locking mechanism by pushing the coverplate towards cranial direction.
4.5 REMOVING THE MIDDLE BLOCK (OPTIONAL)
Remove the middle block by pushing the coverplate towards cranial direction, unlocking the
locking mechanism, and then lift the middle block.
CRANIAL
Middle Block
Coverplate
CAUDAL
4.6 IMMOBILIZING THE PATIENT
Use an Extremity Mask or Pelvic Mask to immobilize the lower extremities or the pelvic area.
For Mask moulding instructions, refer to the instructions for use; IFU117000 - Thermoplastic Masks.

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26042021V7IFU132100 MacroMedics ®
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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26042021V7IFU132100 MacroMedics ®
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.
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 Unsafe
An item which poses unacceptable risks to the patient,
medical staff or other persons within the MR environment.

MacroMedics BV
Oostbaan 670
2841ML Moordrecht
The Netherlands
[phone]
[email protected]
www.macromedics.com
(Visit www.macromedics.com for a digital copy of this manual)