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Manual

Instructions for use

  LEX-Ultra

7

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 identified.

        GS1 Code: (10)

Batch Code

Indicates the manufacturer’s batch code so that the batch or 

lot can be identified.

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.

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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