WillowWood LIMBLOGIC M User manual

1
Prosthetist
Instructions
WHAT'S IN THE BOX
LimbLogic M
Proximal Gasket (2)
M6 X 50 mm Socket Head Capscrews (4)
Split Washer
LimbLogic 4-Hole Adapter
Forming Plate with 4 M6 X 10 mm Capscrews
Poron Filter
Instructions
LimbLogic M Prosthetist Instructions
LimbLogic M Patient Instructions
LimbLogic M Fabrication Instructions
The LimbLogic M is an elevated vacuum suspension system that
operates by compressing with each step and is completely integrated
into the prosthesis without the annoyances of tubes in the socket.
The Ohio Willow Wood Company
15441 Scioto Darby Road
Mt. Sterling, OH 43143
phone [phone]
fax [phone] www.willowwoodco.com
PN-2580-B 19 SEPT 2018
Ohio Willow Wood Company B.V
Keizersgracht 62/64
1015 CS Amsterdam
The Netherlands
Patent www.willowwoodco.com/
education-and-resources/patents

2 3
Unauthorized changes or modifications to the pump
or accessories may impair their function resulting in
injury or death, will void the warranty, and may
prevent their compliance with relevant standards.
This pump is only designed to move air; use of
Vaseline®or similar lubricating creams inside the
socket will clog the pump. Do not allow foreign
substances to be pulled through the pump. This may
impair function of your vacuum system.
LimbLogic is designed for use by a single patient only.
Use on more than one patient may result in cross-
contamination potentially causing a serious infection.
LimbLogic pumps cannot compensate for failures in
the associated prosthetic socket or sealing system.
Only use LimbLogic pumps with commercially proven
socket and sealing systems. Use with other sealing
systems may result in loss of suspension resulting in
injury or death.
TABLE OF CONTENTS
Page
Patient Criteria......................................................................................................4
Fitting Instructions .............................................................................................4
Assembly.................................................................................................................5
Rotation Adjustment.........................................................................................6
Stiness Adjustment .........................................................................................7
Vacuum Level Adjustment..............................................................................9
Patient Briefing ..................................................................................................10
Potential Home Challenges..........................................................................10
Maintenance.........................................................................................................10
Exposure to Water............................................................................................10
Support ................................................................................................................10
Diagnostic Kit........................................................................................................11
Operation at High Altitude........................................................................... 13
Service Life........................................................................................................... 13
Warranty................................................................................................................ 13
Regulatory Information.................................................................................. 14
User Profile........................................................................................................... 15
Performance Characteristics ....................................................................... 15
Physical Measurements.................................................................................. 15

4 5
PATIENT CRITERIA
Indications
Patients who meet the following criteria should be considered
for this system.
• Patients who are transtibial amputees.
• Patients who comment about lack of suspension or feeling
insecure in their current prosthesis.
• Patients who exhibit high cognitive function and are "in
tune" with prosthetic fit.
• Community ambulators whose activity level is at least
Level 2. (Level 2: The patient has the ability or potential for
ambulation with the ability to traverse low-level environ-
mental barriers such as curbs, stairs or uneven surfaces.
This is typical of the limited community ambulator.)
• Patients who prefer simple non-electrical solutions.
• Patients who could benefit from vertical shock reduction.
Contraindications
Patients with any of the following conditions should not be
considered for this system:
• Patients other than transtibial amputees.
• Patients who require the ability to turn o the vacuum
pump or greatly vary the vacuum level.
• Patients who need an audible indication of a leak in their
system.
• Patients who weigh less than 100 lb (45 kg), because they
will be unable to activate the pump
• Patients who weigh more than 330 lb (150 kg) for
U.S. Acitivity Level K2-K3, or more than 300 lb (135 kg)
for U.S. Activity Level K4.
FITTING INSTRUCTIONS
1. Attach the pump to the prosthesis (refer to page 5).
2. Adjust the spring stiffness (refer to page 7).
3. Adjust the vacuum level if desired (refer to page 9).
• For low vacuum mode, turn the 4 mm hex screw
counterclockwise until it comes to a stop
(approximately 3/4 of a turn). For the lowest
possible vacuum level, increase the spring stiffness.
• To return to high vacuum mode, turn the 4 mm hex
screw clockwise until it comes to a stop
(approximately 3/4 of a turn). For the highest
possible vacuum level, decrease the spring stiffness.
Overview Overview
Be sure to fully seat the gasket onto the inlet before
attaching the pump to the socket. Failure to properly
seat the gasket may result in leaks.
ASSEMBLY
1. Fabricate a laminated socket using the LimbLogic 4-Hole
Adapter. Follow the fabrication instructions provided with
the adapter.
2. Apply the proximal gasket to proximal surface of the
pump.
proximal gasket
3. Using the four M6 x 50 mm
socket head screws provided,
attach the pump to the
socket with the logo facing
anterior.
The proximal end of the pump must be attached to
either the LimbLogic 4-Hole Adapter (LLV-01041) or
to the LimbLogic Vacuum Pyramid (LLV-01044).
4. Install the mating pyramid receiver component of your
choice onto the pyramid at the distal end of the pump.
Once alignment has been achieved, follow the torque and
threadlocker specifications provided by the manufacturer
of the pyramid receiver.
OR
If the prosthesis requires a hose
barb connection instead of a
direct mount, attach the pump
to a LimbLogic Vacuum Pyramid
(LLV-01044) using the four
M6 x 50 mm socket head
screws provided.
Apply Loctite 242 (or equivalent) and tighten the screws
to 9 ft-lbs (12 Nm).
You should be able to turn
the pump upside down
without the gasket falling
o. If the gasket falls o,
it was not properly seated
into the recess.

6 7
ROTATION ADJUSTMENT
To make a rotation adjustment before assembling the
prosthesis, use an adjustable wrench to rotate the pyramid to
the desired position.
Overview
To make a rotation adjustment after assembling the prosthesis:
1. Loosen two adjacent 8 mm setscrews on the pyramid
receiver.
2. Turn the prosthesis to rotate the pyramid to the desired
position.
3. Tighten the 8 mm setscrews using the torque and thread-
locker specifications provided by the manufacturer of the
pyramid receiver.
4. Turn the wrench as follows:
• Turn the wrench clockwise to make the pump feel
stiffer and to reduce deflection.
• Turn the wrench counterclockwise to make the pump
feel softer and to increase deflection.
5. Reinstall the pyramid receiver to the pyramid on the
distal end of the pump. Follow the torque and thread-
locker specifications provided by the manufacturer of the
pyramid receiver.
STIFFNESS ADJUSTMENT
1. In order to maintain alignment, make a reference mark to
indicate the rotation of the pyramid on the distal end of
the pump.
2 Disconnect the pyramid receiver from the pyramid.
If desired, use the included split washer to observe the amount
of pump deflection:
3. Insert a 4 mm Allen wrench
into the hole on the distal
end of the pyramid.
1. Open the split
washer and apply it
to the pump shaft.
Overview

8 9
2. Push the split washer up as proximal as possible on the
shaft.
3. Ask the patient to take several steps.
4. When the amputee stops walking, the washer will remain
at its fullest deflection, indicating the maximum travel of
the pump.
5. Remove the split washer when the evaluation is complete.
split washer
at its most
proximal
position
split washer
position
indicating
maximum
deflection
Keep fingers and toes away from the pump while
walking.
Overview
VACUUM LEVEL ADJUSTMENT
The LimbLogic M features two settings for the vacuum level: Low and
High. The pump is shipped with the setting at High.
To change the Vacuum Level Setting to Low:
Overview
The pump is now in low vacuum mode. The vacuum level for an
average user will not exceed 16 inHg.
To change the Vacuum Level Setting back to High:
1. Locate the exposed 4 mm hex screw on the posterior side
of the pump.
2. Using a 4 mm Allen wrench, rotate the screw clockwise
until it comes to a stop (approximately 3/4 of a turn).
1. Locate the exposed
4 mm hex screw on
the posterior side of
the pump.
2. Using a 4 mm Allen wrench, rotate the screw counterclock-
wise until it comes to a stop (approximately 3/4 of a turn).
4 mm hex screw

10 11
Overview
SUPPORT
If you encounter problems that you cannot solve, or encounter
unexplained behaviors, contact WillowWood at 800.848.4930
for support.
Under normal conditions, you should not need to flush or
sanitize your pump. If a pump starts to smell, or if you suspect
contamination, contact WillowWood for support. Do not flush
the pump unless you are directed to do so by WillowWood.
POTENTIAL HOME USE CHALLENGES
The pump is unlikely to be damaged by exposure to lint, dust,
or light.
While not necessary, outside surfaces can be cleaned by wiping
with a water-dampened cloth.
Do not allow children or pets to play with LimbLogic M or its
accessories. While designed for durability, they may be damaged
if exposed to untrained or rough handling.
EXPOSURE TO WATER
Do not submerge the LimbLogic M in liquid.
PATIENT BRIEFING
The LimbLogic M has been designed and tested for durability and
usage in common environments. While unlikely to result in unsafe
performance, there are extreme conditions which may affect the
LimbLogic M’s function.
Be sure to train patients:
• Not to use their LimbLogic M in corrosive environments, such as
salt water.
• Not to use the LimbLogic M outside of its specified range of
environmental conditions. (Refer to “Performance
Characteristics” on page 15.)
• How to release the vacuum in their socket.
• To obtain medical attention in the event of an open wound on
their residual limb.
• To keep fingers and toes away from pump while compressing
the pump.
• How to contact you, as WillowWood’s representative to this
patient, in the event that they have questions about the
configuration, use, or maintenance of their LimbLogic M.
MAINTENANCE
Wipe the inside of the socket as needed to prevent the pump
from drawing in debris.
Do not add oil or grease to the pump.
Overview
DIAGNOSTIC KIT
The Diagnostic Kit (LLM-11001) can be used to evaluate the
vacuum level of the system to diagnose the source of a leak.
The kit contains a Diagnostic Plate, M6 x 60 mm bolts, a
proximal gasket, a tube, a Diagnostic Disc, and a vacuum gauge.
1. Remove the pump from the socket.
5. Install the gauge.
Ask the amputee to
activate the pump by
shifting their weight on
and o of the prosthesis.
Observe the vacuum
level with the gauge.
4. Bolt the pump onto the
socket with the M6 x 60 mm
bolts.
2. Place a gasket on the
Diagnostic Plate.
3. Place the Diagnostic Plate
with the gasket on top of
the pump inlet and gasket.
gasket
two gaskets:
one on top
of Diagnostic
Plate;
one between
pump and
Diagnostic Plate

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• If the vacuum level is adequate, remove the
Diagnostic Plate and reinstall the pump with the
M6 x 50 mm bolts.
• If a leak is detected:
6. Remove the Diagnostic Plate and Diagnostic Disc before
allowing the patient to leave with the prosthesis.
Diagnostic
Disc
a. Remove the pump. Install the Diagnostic Disc as
shown.
b. Bolt the pump onto
the socket with the
M6 x 60 mm bolts.
c. Install the gauge.
Ask the amputee to activate the pump by shifting
their weight on and o of the prosthesis. Observe
the vacuum level with the gauge.
• An adequate
vacuum level
indicates that the
leak is in the sleeve
or the socket.
• If a pump leak
is detected, call
WillowWood
Customer Care at
800.848.4930.
Overview
OPERATION AT HIGH ALTITUDE
At high altitude, the pump will operate at a reduced eciency,
reducing the amount of vacuum provided and increasing the
amount of steps required to achieve vacuum.
SERVICE LIFE
The LimbLogic M pumps are designed for a reliable service life of
at least two years.
WARRANTY
The warranty for the LimbLogic M is two years from fit date.
Use of the LimbLogic M for amputees whose adjusted body
weight is more than 330 lb or 150 kg (or more than 300 lb
or 135 kg for U.S. Activity Level K4*) or who engage in
extremely high and abusive activity is against WillowWood’s
recommendations and will void the warranty. Adjusted body
weight is defined as the weight of the amputee plus any loads
normally or routinely carried by the amputee. “Extremely
high and abusive activities” are defined as activities such as
skydiving, karate, and judo; activities that could result in injury
to an individual’s natural limbs; and activities that expose the
prosthesis to corrosives such as salt water.
*Level 4: Has the ability or potential for prosthetic ambulation
that exceeds basic ambulation skills, exhibiting high impact,
stress, or energy levels. Typical of the prosthetic demands of
the child, active adult, or athlete.
WARRANTY DISCLAIMER
WillowWood warrants that each product manufactured will, at the
time of delivery, be of workmanlike quality and substantially free of
defects. WILLOWWOOD MAKES NO OTHER WARRANTY, IMPLIED,
OR EXPRESSED, AND MAKES NO WARRANTY OF
MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE.
This warranty shall terminate immediately upon an action to
combine our products with other materials or in any manner to
change the nature of our products. The sole remedy is replace-
ment of the products or credit for the products. WillowWood’s
liability shall not exceed the purchase price of the product.
WillowWood shall not be liable for any indirect, incidental, or
consequential damage.
WILLOW WOOD RETENTION OF RIGHTS
WillowWood retains all intellectual property rights reflected or
incorporated in its physical products, regardless of the transfer
of the physical products to another party or parties.
There are no field-serviceable parts inside the Vacuum Pump.
Opening the Vacuum Pump will void the warranty.
Technical Information

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Symbol Definition
Acceptable temperature range for long
term storage.
Acceptable humidity range for long term
storage.
Acceptable pressure range for long term
storage.
Consult instructions for use.
Adjacent to Manufacturers name and
address.
This product complies with applicable
standards for sale and use in EC countries.
REGULATORY INFORMATION
Return this product to the factory for proper disposal.
Essential performance
The distally mounted pump is designed to provide structural
support when assembled into a prosthesis and complies to ISO
10328 for this function.
Technical Information Technical Information
USER PROFILE
Prosthetist user
LimbLogic M is intended to be used for assembly of prosthetic
devices by a certified prosthetist or prosthetic technician.
Patient user
LimbLogic M is intended for use by patients meeting the
following conditions.
– Age: Any. Determined by clinician’s evaluation of patient
competence and health.
- Minimum weight to activate the pump: 100 lb (45 kg)
– Maximum weight: (Body weight plus any loads normally or
routinely carried cannot exceed these weight limits.)
<330 lb (150 kg) for U.S. Activity Level K2-K3
<300 lb (135 kg) for U.S. Activity Level K4
– Health: Activity Level K2-K4
– Mentally competent to operate system as judged by
prosthetist.
PERFORMANCE CHARACTERISTICS
Restrictions
– Though this WillowWood component is resistant to fresh water
splashes, light sprays and sanitizing with damp cloths, it is not
rated for prolonged exposure to moisture and liquids such as
partial or total immersion in water (as in swimming, bathing and
showering). This product is also not rated for pressure sprays,
any salt water contact as well as exposure to chlorinated water,
soaps and any liquid with chemical content.
PHYSICAL MEASUREMENTS
Dimensions (mm): 62L x 51W x 105H
Weight (gms): 475
LimbLogic M Vacuum Pump
Blocking or plugging the exhaust port of the vacuum control
assembly will prevent proper operation of the vacuum pump.
The LimbLogic M Vacuum Pump is intended for use on
a single patient. Use of the system with multiple patients
could lead to cross contamination between patients.
The LimbLogic M vacuum system has been designed
for and clinically tested as a suspension aid. It has not
been clinically tested for wound healing or other uses.
WillowWood does not currently support the use of the
LimbLogic M for uses other than suspension and shock
absorption.
Use only the bolts supplied by WillowWood. All testing
for the LimbLogic M vacuum system has been tested
with the bolts included with the system. Use of other
bolts could result in mechanical failure.