MacroMedics LEPS User manual

MANUAL 130300
Instructions for use
English Instructions
MacroMedics BV
Oostbaan 670
2841ML Moordrecht
The Netherlands
[phone]
[email protected]
www.macromedics.com
Lower Extremity Positioning System
MacroMedics ®LEPSTM

Manual
Instructions for use LEPS
2
26042021V16IFU130300 MacroMedics ®
[ This page is intentionally left blank ]

Manual
Instructions for use LEPS
3
26042021V16IFU130300 MacroMedics ®
Table of Contents
1. Warnings 4
2. MRI Safety Information 4
3. Intended Use 4
4. Installation Instructions 5
5. Cleaning, Storage & Disposal 12
6. Warranty 12
7. Notices 12
8. Glossary of Symbols 13

Manual
Instructions for use LEPS
4
26042021V16IFU130300 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.
• 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.
2. MRI Safety Information
2.1 MR CONDITIONAL
The following devices are MR conditional:
• 130300 LEPS™, FeetSupport™, rot.
• 130310 LEPS™, FeetSupport™, xed
• 130250 FeetSupport™, xed
• 130260 FeetSupport™, rotatable
The devices labelled as MR Conditional can be safely used in a MR system meeting the
following conditions:
• Static magnetic eld of 1.5 Tesla and 3 Tesla, with
• Maximum spatial eld gradient of 2,500 G/cm (25 T/m)
• Maximum force product of 50,000,000 G²/cm (50 T2/m)
Due to size and location of the metallic parts, no clinically signicant RF heating is expected.
2.2 MR SAFE
The following devices are MR safe:
• 130200 LEPS™ baseplate
• 130350 Shoulder retr. for LEPS™
• 130420 LEPS™ baseplate short
• 130100 KneeSupport™
• 130120 KneeSupport™ LiftBlock™
• 130130 KneeSupport™ low, plastic
• 130140 KneeSupport™, plastic
3. Intended Use
Positioning of the patient during radiotherapy and radiodiagnostics, including MR where indicated.

Manual
Instructions for use LEPS
5
26042021V16IFU130300 MacroMedics ®
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.
4.1 PLACING THE LEPS.
I. Place the CouchStrips on a desired position on the CouchTop. Make sure that the distance
between the Couchstrips align with the designated slots in the LEPS baseplate.
II. Place the LEPS baseplate on the CouchStrips to secure it on the CouchTop.

Manual
Instructions for use LEPS
6
MacroMedics ®
III. Place the LiftBlock on the LEPS baseplate.
IV. 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
Short patients: Position 4
26042021V16IFU130300

Manual
Instructions for use LEPS
7
26042021V16IFU130300 MacroMedics ®
V. Before placing the FeetSupport onto the baseplate, push the locking plates on the base of the
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.

Manual
Instructions for use LEPS
8
26042021V16IFU130300 MacroMedics ®
4.2 PLACING THE SHOULDER RETRACTOR.
I. 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.

Manual
Instructions for use LEPS
9
26042021V16IFU130300 MacroMedics ®
II. Insert a Shoulder Retractor into each Shoulder Retractor Side Strip, with the wrist bands upwards,
and turn it towards the cranial direction.

Manual
Instructions for use LEPS
10
26042021V16IFU130300 MacroMedics ®
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.
4.3 PLACING THE LEPS SHORT
The LEPS Short baseplate can be used with a FeetSupport to position the patient’s feet.
I. Place one CouchStrip nearing the caudal end of the baseplate.

Manual
Instructions for use LEPS
11
26042021V16IFU130300 MacroMedics ®
II. Align the LEPS baseplate above the CouchTop. Make sure that the CouhStrip fall into the
designated slot of the 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.

Manual
Instructions for use LEPS
12
26042021V16IFU130300 MacroMedics ®
5. Cleaning, Storage & 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 detailed on the
product.
• 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 LEPS in a upright position.
• 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.

Manual
Instructions for use LEPS
13
26042021V16IFU130300 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 Conditional
An item with demonstrated safety in the MR environment
within dened conditions.

Manual
Instructions for use LEPS
14
26042021V16IFU130300 MacroMedics ®
[ This page is intentionally left blank ]

Manual
Instructions for use LEPS
15
26042021V16IFU130300 MacroMedics ®
[ This page is intentionally left blank ]

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)