14
15
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.
