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Manual

Instructions for use

  LEX-Ultra

6

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 fluid, 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.

Summary of Contents for LEX-Ultra

Page 1: ...MacroMedics BV Oostbaan 670 2841ML Moordrecht The Netherlands 31 0 182 389 777 info macromedics com www macromedics com MANUAL 132100 Instructions for use English Instructions MacroMedics LEX Ultra ...

Page 2: ...EX Ultra 2 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 ...

Page 3: ...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...

Page 4: ...hTop Optional Screw the fixed 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...

Page 5: ...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 ...

Page 6: ...e 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 ...

Page 7: ...se 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 th...

Page 8: ...MacroMedics BV Oostbaan 670 2841ML Moordrecht The Netherlands 31 0 182 389 777 info macromedics com www macromedics com Visit www macromedics com for a digital copy of this manual ...

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