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MANUAL 130300
Instructions for use
English Instructions
MacroMedics
LEPS
®
TM
Lower Extremity Positioning System
MacroMedics BV
Oostbaan 670
2841ML Moordrecht
The Netherlands
+31(0)182 389 777
info@macromedics.com
www.macromedics.com

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Summary of Contents for MacroMedics LEPS

  • Page 1 MANUAL 130300 Instructions for use English Instructions MacroMedics LEPS ® Lower Extremity Positioning System MacroMedics BV Oostbaan 670 2841ML Moordrecht The Netherlands +31(0)182 389 777 info@macromedics.com www.macromedics.com...
  • Page 2 Manual LEPS Instructions for use [ This page is intentionally left blank ] 26042021V16IFU130300 MacroMedics ®...
  • Page 3: Table Of Contents

    Manual LEPS Instructions for use Table of Contents 1. Warnings 2. MRI Safety Information 3. Intended Use 4. Installation Instructions 5. Cleaning, Storage & Disposal 6. Warranty 7. Notices 8. Glossary of Symbols 26042021V16IFU130300 MacroMedics ®...
  • Page 4: Warnings

    • Secure the device properly before positioning the patient. • Remove all accessory devices before moving or storing the LEPS baseplate, as otherwise they may fall and become damaged. • In the USA, federal law restricts this device to sale by or on the order of a licensed healthcare practioner.
  • Page 5: Installation Instructions

    LEPS Instructions for use 4. Installation Instructions The LEPS supports the positioning of the patient’s pelvic region and lower extremities. Shoulder Retractors can be optionally added to the system to enable the depression of the patient’s shoulders. PLACING THE LEPS.
  • Page 6 Manual LEPS Instructions for use III. Place the LiftBlock on the LEPS baseplate. Place the KneeSupport on top of the LiftBlock. If needed, a KneeSupport can be placed without a LiftBlock. Recommendation for indexing KneeSupport position: Tall patients: Position 1...
  • Page 7 FeetSupport in cranial direction to unlock the holes. When the slots are open, the FeetSupport can be placed over the pins of the LEPS baseplate. Pull the black locking plates in caudal direction to lock the FeetSupport to the baseplate.
  • Page 8 Instructions for use PLACING THE SHOULDER RETRACTOR. Unscrew the screws on both sides to remove the LEPS Side Strips from the LEPS baseplate. Place the Shoulder Retractor Side Strip on both sides of the LEPS baseplate. Use the same screws to secure them.
  • Page 9 Manual LEPS Instructions for use Insert a Shoulder Retractor into each Shoulder Retractor Side Strip, with the wrist bands upwards, and turn it towards the cranial direction. 26042021V16IFU130300 MacroMedics ®...
  • Page 10 Instructions for use III. Position the patient on the LEPS system. Place the patient’s hand through the wrist bands and instruct the patient to hold tight. The more caudal the position of the Shoulder Retractor, the more the patient’s shoulders are in a depressed position.
  • Page 11 LEPS Short baseplate. Carefully place the LEPS Short baseplate. III. Place the FeetSupport on the LEPS baseplate short. Adjust its position. Lock it by pulling the locking plates at the base of the FeetSupport in caudal direction.
  • Page 12: Cleaning, Storage & Disposal

    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.
  • Page 13: Glossary Of Symbols

    Manual LEPS Instructions for use 8. Glossary of Symbols Symbol Symbol Name Description of Symbol EC declaration of conformity by manufacturer. European Conformity Indicates the medical device manufacturer. Manufacturer Indicates the manufacturer’s catalogue number so that the Catalogue Number medical device can be identified.
  • Page 14 Manual LEPS Instructions for use [ This page is intentionally left blank ] 26042021V16IFU130300 MacroMedics ®...
  • Page 15 Manual LEPS Instructions for use [ This page is intentionally left blank ] 26042021V16IFU130300 MacroMedics ®...
  • Page 16 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)