Prosthetist’s
Guide
This document provides instruction for the prosthetist in
the installation and use of the system. A separate document,
LimbLogic VS Patient Information, is included with each
system and should be provided to the patient upon delivery
of a prosthesis containing the LimbLogic VS.
The Vacuum Pump and fob included in this package are
electronically keyed together and can be used only with
each other.
LimbLogic VS - 1600 Series is now waterproof.
1
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 Vacuum Pump. This may impair function of your vacuum
system.
Do not allow acetone to contact the Vacuum Pump or fob.
The LimbLogic VS is not intended to be used as the only
means of attachment of prosthesis to patient.
All LLVS components have passed safety testing for use as
medical devices. Radio enabled devices transmit with a power
of less that one milliwatt and comply with United States and
international guidelines for low power transceivers. If LLVS
components will be used around safety critical devices such
as pacemakers or defibrillators, consult the manufacturer
for appropriate usage instructions. Consult the section on
Regulatory Information for more information on safety and
compliance.
2
Table of Contents
Page
Quick-Start Guide...................................................................................4
Keys to Successful Use...........................................................................5
BK Application.................................................................................6
AK Application.................................................................................7
Introduction.............................................................................................8
Vacuum System Function.......................................................................8
Charging the Vacuum Pump Battery.......................................................9
Charging the Vacuum Pump Battery in a Vehicle...........................10
Turning on the Vacuum Pump...............................................................11
Turning on the Fob................................................................................12
Information Screen................................................................................13
Active Mode...................................................................................13
For Bilateral Applications........................................................14
Standby Mode.................................................................................14
Configuration Screen............................................................................15
Detecting a Leak...................................................................................16
If the Sealing Sleeve is Punctured.........................................................16
No Radio Connection............................................................................17
Low Battery Mode................................................................................17
Turning Off the Vacuum Pump.............................................................17
Cleaning the System ............................................................................18
Exposure to Water.................................................................................18
Accessories...........................................................................................19
Troubleshooting Guide.........................................................................20
Diagnostic Kit Instructions...................................................................24
Warranty................................................................................................25
Regulatory Information.........................................................................27
3
Overview
Quick-Start Guide
1. Turn on the Vacuum Pump.
Press
one time
2. Start regulating the vacuum.
Press
one more
time
Press and hold
center button
until LimbLogic VS
logo appears
in display
or
3. Information about the system is displayed.
Vacuum Pump
battery charge level
current upper
set point
(press up and down
buttons to adjust,
and center button
to confirm)
current vacuum level
4. To enter Standby Mode:
Press
center button
until
Standby
Mode
appears
To resume vacuum regulation:
Press
center button
until
appears
5. Turn off the Vacuum Pump.
Press
two times
4
Overview
Keys to Successful Use
1. Fabricate a non-porous Total Surface Weight Bearing socket
using a LimbLogic VS 4-Hole Attachment Plate. This is critical to
the proper operation of the system. Be sure to follow the fabrication
instructions provided with the 4-Hole Attachment Plate.
Prior to delivering the prosthesis, you may want to use the Diagnostic
Kit (LLV-1300) to confirm that there are no leaks in the system.
2. Fully charge the Vacuum Pump. (Refer to “Charging the Vacuum
Pump Battery” on page 9.)
3. Properly secure the fully charged Vacuum Pump to the socket,
Vacuum Plate (LLV-01043), or Vacuum Pyramid (LLV-01044) with
M6 flathead screws. Tighten the screws to 9 ft-lbs (12 Nm).
4. Assemble the prosthesis, inserting one end of the exhaust port tubing
into the exhaust port. Attach the other end of the tubing as desired.
Exhaust Port
Tubing
Exhaust Port
5. Have the patient don an Alpha® Liner, the prosthesis, and an Alpha
Sleeve. For the best seal proximally, the patient should fold over the
top edge of the liner and roll the sleeve up onto the folded edge
to create a gel-to-gel seal, as shown in the figures on pages 6 and 7.
5
Overview
BK Application
The patient should don an Alpha Liner and Alpha Flex Sleeve as shown
below.
Fabric side of
Alpha Liner
Gel side of
Alpha Liner
Socket
Figure 1:
Folding over the top
edge of the liner
Alpha Flex
Sleeve
Gel side of
Alpha Liner
Fabric side of
Flex Sleeve
Gel side of
Flex Sleeve
6
Figure 2:
Rolling the sleeve
up onto the folded
edge of the liner
Overview
AK Application
The patient should don an Alpha Liner and Alpha AK Sleeve as shown
below.
Gel side of
Alpha Liner
Socket
Figure 3:
Top edge of the liner
is folded over the
brim of the socket
Gel side of
Alpha Liner
Fabric side of
AK Sleeve
Figure 4:
Sleeve is rolled up
onto the folded edge
of the liner
Socket
7
Overview
Introduction
The LimbLogic VS is a remote-controlled
vacuum suspension system. The Vacuum
Pump is mounted inline on a prosthesis
to allow for complete integration without
the annoyances of tubes into the socket.
LimbLogic VS operates quietly and
features “Set and Forget” monitoring,
which means that the system monitors
the level of vacuum in the socket to
maintain a secure and comfortable fit.
Vacuum System Function
Lower
Set Point
0 in-Hg
Upper
Set Point
Vacuum Control Range
User
Maximum
20 in-Hg
(System Maximum)
The system monitors the vacuum level and draws more vacuum as
needed to maintain the level between a minimum value (the Lower Set
Point) and a maximum value (the Upper Set Point). The difference
between the Lower Set Point and the Upper Set Point is called the
Vacuum Control Range. The Upper Set Point cannot be set higher
than the User Maximum. The User Maximum cannot be set higher than
the System Maximum of 20 in-Hg.
The prosthetist may adjust the User Maximum as well as the width of the
Vacuum Control Range. Both the prosthetist and the patient may adjust
the Upper Set Point.
The optimum vacuum setting is different for each amputee. Keep
in mind that a higher vacuum level is not always better. Higher
vacuum levels require that the Vacuum Pump use more power and
will therefore discharge the battery faster.
8
Overview
Charging the Vacuum Pump Battery
Vacuum Pump
Charger
To
AC
outlet
charging port
charging plug
charger node
Align the green
mark on the plug
with the green
mark on the port.
Green LED
SOLID = charging
FLASHING = charged
reset button
1. Remove the cap from the charging port on the Vacuum Pump.
2. Insert the charging plug into the charging port as follows:
a) Gently insert the plug into the port, holding the black plastic
portion of the plug, with just enough force to feel the plug touch
the port.
b) Align the green alignment marks on the charging port and the
charging plug.
The charging plug can only be inserted into the Vacuum
Pump charging port in one orientation. Forcing the plug will
damage the plug, will possibly damage the vacuum system,
and will void the warranty.
3. Plug the charger into a power outlet. The blue light on the two-pronged
adapter will light, followed by the green LED. The fob will display the
battery charging indicator.
If the green LED does not light, press and hold the reset button until
the light comes on.
4. When charging is complete, the green LED will flash. Disconnect
the power cord from the Vacuum Pump and from the power outlet.
9
Overview
5. Reinstall the cap onto the charging port on the Vacuum Pump.
Use ONLY an Ohio Willow Wood charger. For LLV-01042
series Vacuum Pumps use Ohio Willow Wood charger part
number LLV-01011. For LLV-01040 series Vacuum Pumps
use Ohio Willow Wood charger part number LLV-01010.
Use of any other charger may result in damage to the
Vacuum Pump or the charger or both.
If the charger needs to be reset, press the reset button. With normal
usage, the rechargeable battery should last for the life of the product.
Charging the Vacuum Pump Battery in a Vehicle
To use a vehicle’s power to charge the Vacuum Pump, you must purchase
a Power Inverter rated at 75 Watts or less to convert the vehicle’s 12V DC
power to 120V AC. Examples of acceptable Power Inverters include the
Digital Concepts™ 75 Watt Portable Power Inverter (available from
general retailers) and the Enercell™ 75 Watt Power Inverter (available
from Radio Shack®; item number 22-133).
1. Plug the Power Inverter into the vehicle’s cigarette lighter socket.
2. Connect the charger to the Vacuum Pump.
3. Plug the charger’s two-pronged adapter into the Power Inverter’s
three-pronged receptacle.
10
Overview
Turning on the Vacuum Pump
on/off button
Press the on/off button on the Vacuum Pump one time. The pump will
vibrate four times.
Note: if the pump has just been unplugged from the charger, the button
does not need to be pressed.
When you are ready for the pump to begin regulating the vacuum,
press the on/off button again (or turn on the fob, as described on the
next page). The pump will operate until the preselected vacuum level is
reached.
11
Overview
Turning on the Fob
Up/down buttons:
adjust vacuum setting
up
button
left
button
right
button
center
button
down
button
Center button:
apply setting
Right/left buttons:
toggle between right
and left Vacuum Pumps
(bilateral only)
Press and hold the center button on the fob until the LimbLogic VS
logo appears and the display has reached the desired brightness.
Release the button. If the Vacuum Pump is charged and powered, the
Information Screen will be displayed.
The fob shuts off after one minute of non-use. This will not affect the
Vacuum Pump. Press and hold the center button to restart the fob.
12
Overview
Information Screen
The Information Screen indicates important details about the operation of
the system.
The vertical bars inside the battery symbol on the right side
of the screen indicate the amount of charge left in the Vacuum
Pump battery.
As the battery is discharged, the bars disappear from left to right.
A) Active Mode
When numbers are displayed to the left of the battery symbol, as
shown below, the system is in Active Mode. In this mode, the Vacuum
Pump activates as needed to maintain the vacuum settings.
current upper
set point
current vacuum level
You or the patient may use the up/down buttons to adjust the Upper
Set Point as desired. This is the only setting the patient may adjust.
The Upper Set Point cannot be set higher than the User Maximum.
Press the center button to save the change. The hourglass
symbol will appear to indicate that the setting is being saved.
13
Overview
For bilateral applications:
The Information Screen displays right and left indicators to show
which pump is currently communicating with the fob.
Use the right/left buttons to select the right or left Vacuum Pump, then
press the center button to save your selection.
The LimbLogic VS logo will appear, followed by the Information
Screen for the selected pump.
In this example, the fob is
communicating with the
RIGHT pump
In this example, the fob is
communicating with the
LEFT pump
B) Standby Mode
Allows you to turn off the pump temporarily to prevent the pump from
regulating the vacuum.
To enter Standby Mode, press and hold the center button until
the hourglass symbol appears.
The standby indicator will then appear to indicate that the
pump is not regulating.
To return to Active Mode, press and hold the center button until
the hourglass symbol appears.
After six hours of Standby Mode without radio communication, the
unit will turn off. To turn the pump back on, either press the on/off
button on the Vacuum Pump one time or plug in the charger.
Keep in mind that a Vacuum Pump in Standby Mode will
continue to use the pump battery.
14
Overview
Configuration Screen
The system is shipped with the User Maximum set at 20 in-Hg and
the Vacuum Control Range set at 6 in-Hg. If these settings are not
sufficient for your patient, you may adjust them as follows:
With the Information Screen displayed, press the left and right
buttons simultaneously.
After the warning screen flashes,
you will see the Configuration Screen.
Use the right and left buttons to adjust the User Maximum.
The User Maximum cannot be set higher than 20 in-hg.
In this example,
the User Maximum
is set at 18 in-Hg
Press the up or down button to scroll to the next screen.
Use the right and left buttons to adjust the Vacuum Control
Range. The Vacuum Control Range cannot be set lower
than 4 in-hg.
In this example,
the Vacuum Control Range
is set at 4 in-Hg
Note: Increasing the Vacuum Control Range and decreasing the User
Maximum setting may reduce pump cycling and may increase pump
battery life.
Press the center button to exit the Configuration Screen and
save all current settings.
15
Overview
Detecting a Leak
If the leak indicator appears when the patient initially dons the
prosthesis, the patient should restart the pump.
If the leak indicator appears frequently while the patient is
walking, use the Diagnostic Kit (LLV-1300) to determine the
source of the leak.
To resume automatic vacuum regulation after a leak has been detected:
• Press the center button on the fob until the hourglass symbol appears,
or
• Press the on/off button on the Vacuum Pump one time.
If the Sealing Sleeve is Punctured
The latex sleeves (LLS-3N, LLS-4N, or LLS-5N) in the
Diagnostic Kit are to be used ONLY as a diagnostic tool for
locating the source of a leak. If a leak is fixed by replacing a
sealing sleeve with a latex sleeve, then the patient should receive
a new sealing sleeve immediately. The patient should NOT be
sent home with a latex sleeve, because the mineral oil in the
Alpha gel causes the latex to lose its elasticity.
16
Overview
No Radio Connection
If the No Radio Connection indicator appears:
• make sure the Vacuum Pump has been turned on
• make sure the Vacuum Pump battery has been charged
• make sure the fob is within 3 feet of the Vacuum Pump
• make sure the fob is more than 3 inches away from the
Vacuum Pump
If the No Radio Connection indicator still appears, contact
Ohio Willow Wood.
Low-Battery Mode
If the Vacuum Pump battery has less than 15% of its capacity
remaining, the Vacuum Pump enters a “stutter” mode.
(Stutter mode is when the pump quickly turns on and off when pulling
vacuum.) Charge as soon as possible.
The fob will display the battery charging indicator when the
unit is plugged into the charger.
Turning off the Vacuum Pump
Press the on/off button on the Vacuum Pump two times. The Vacuum
Pump will vibrate twice.
If the current vacuum level is near the current Upper Set Point, the
Vacuum Pump may skip the vibrations to prevent the vacuum level
from exceeding the Upper Set Point.
17
Overview
Cleaning the System
Once a month, the patient should pour 1/8 cup of distilled water or
rubbing alcohol into the socket, place the end of the exhaust port tubing
into a cup, and activate the Vacuum Pump. Use ONLY distilled water
or rubbing alcohol to clean the system.
Do not use acetone or similar chemicals to clean the system.
Please demonstrate this procedure for the patient before sending the
patient home with the system.
Exposure to Water
The Vacuum Pump is waterproof in fresh water up to a depth of 10 feet or
3 meters for up to 12 hours. The Vacuum Pump should not be submersed
in salt water. Be sure to dry off the Vacuum Pump if it is exposed to rain or
other moisture.
The fob is not water resistant. Submersion of the fob will void the warranty.
18
Overview
Accessories
Cosmesis Kit
The Cosmesis Kit (LLV-01046) extends the Vacuum Pump’s charging
port and on/off button so that they are flush with the surface of a
cosmetic cover. The kit also includes a hose barb for routing the exhaust
tube into the foot shell.
Vacuum Plate/Pyramid
The Vacuum Plate (LLV-01043) and Vacuum Pyramid (LLV-01044) can
be used for attaching the Vacuum Pump in line with other endoskeletal
components, instead of attaching the pump directly to the socket.
Vacuum Plate
Vacuum Pyramid
19
Overview
Troubleshooting Guide
Problem
Action
• The pump’s internal battery may not be
The pump does not
charged. Charge the pump with the charger
vibrate when the on/
for at least 30 minutes and try again.
off button is pressed
• The on/off button could be damaged. Verify
once and the charger
that the rubber boot is intact and hasn’t been
is not connected to the
torn from impact. Contact Ohio Willow
pump.
Wood if the switch needs to be replaced.
• The pump may have ben exposed to a large
static discharge. Plug in the charger and
press the reset button to reset the pump. The
charger does not need to be plugged into an
outlet.
• Do not press the on/off button too quickly.
Pressing the pump
Press the button for one second, then release
button, waiting for the
for one second before pressing again, so
start-up vibrations,
that the system recognizes separate button
and then pressing the
presses.
button again does not
• The pump’s internal battery may not be
start the pump.
charged. Charge the pump with the charger
(To prevent excessive
for at least 30 minutes and try again.
vacuum, the pump
• The pump could already be in automatic
will not vibrate if it
mode. Pressing twice when the unit is in
is already holding a
automatic mode or standby mode will turn
vacuum when it is
the unit completely off. Wait 15 seconds,
started up.)
then press the on/off button once and verify
that the pump vibrates to indicate it is in
standby mode. After vibration, press a
second time to transition the pump to
automatic mode.
• The pump may have ben exposed to a large
static discharge. Plug in the charger and
press the reset button to reset the pump. The
charger does not need to be plugged into an
outlet.
continued on next page
20
Overview
Problem
Action
Pump battery does not • Ensure that the system is properly sealed.
maintain charge for a • Ensure that the battery has been charged for
at least 4 hours.
full day.
• The pump may have ben exposed to a large
static discharge. Plug in the charger and
press the reset button to reset the pump. The
charger does not need to be plugged into an
outlet.
• Ensure that your socket does not leak
excessively.
• Make sure the pump is on by pressing the
The fob does not
on/off button once and verify that the pump
communicate with the
vibrates in recognition of the button activation.
pump. The LimbLogic
Wait one minute for the fob screen to turn
VS logo appears and
off. Press the fob center button again.
is followed by the No
• The fob may be too close or too far from the
Radio Connection
pump. Place the fob about 2 feet away from
icon.
the pump, and press the fob center button
again.
• The pump’s internal battery may not be
charged. Charge the pump with the charger
for at least 30 minutes and try again.
• Does the patient have the correct fob-pump
combination? The fob and pump are
electronically matched during the production
process. Contact Ohio Willow Wood with the
serial number of the fob and serial number of
the pump to verify that the set is matched.
• The pump may have ben exposed to a large
static discharge. Plug in the charger and
press the reset button to reset the pump. The
charger does not need to be plugged into an
outlet.
continued on next page
21
Problem
Action
The green LED on
• Make sure that the green marks on the
the charger node does
charging port and the charging plug are
not illuminate or blink
aligned (page 9). Do not force the
when the charger is
connection.
plugged into vacuum • The pins on the charger plug may be bent.
pump and AC outlet.
Unplug the charger from the vacuum
pump and inspect the pins. Do NOT try to
straighten pins while charger is plugged into
an AC outlet! If the pins are bent or broken,
contact Ohio Willow Wood.
• With the charger plugged into an AC outlet
and the pump, press and hold the reset button
on the charger node for 5 seconds, then
release. If the green LED does not blink or
turn solid within 5 seconds after the button
release, contact Ohio Willow Wood.
• If charger plug pins have been bent or the
plug has been forced into pump, the internal
electronics of the pump can be damaged,
or the green LED on the charger could be
damaged. Use the fob to check the pump
battery level, then charge the pump for
2 hours and re-check the battery level to
verify that the level has increased. If the
level has not increased, contact Ohio
Willow Wood.
continued on next page
22
Overview
Problem
Action
Pressing the center of
the button of the fob
does not display the
LimbLogic VS logo.
The fob battery may need to be reset.
Remove the back cover of the fob per the
instructions in the Patient Information
booklet, then remove and reinstall the
battery. If the problem persists, the battery
is likely dead and must be replaced per
the instructions in the Patient Information
booklet.
The blue LED light
on the charger does
not illuminate when
plugged into the wall.
• The AC electricity to the wall outlet may not
be turned on. Try plugging the charger into
a different non-switched wall outlet or in
another room.
• The configurable prong may not be seated
properly in the back of the charger’s twopronged adapter. Unplug the charger from
the AC outlet. Remove the charger’s prong
using the sliding latch on the back of the
adapter. Verify that the metal contacts are
springy and are not completely flat against
the adapter. Re-install the plug prongs.
The pump makes a
“zip zip zip” sound
as it controls the
vacuum.
The system is leaking, but not yet at a rate that
triggers the Leak Detection symbol. Wash
the sealing sleeve of debris around the sealing
surface, and remove any dirt or debris from
the proximal sealing gasket and the pump’s
sealing surface. If the leak is still present, use
the Diagnostic Kit (LLV-1300) to determine the
source of the leak. Refer to the Diagnostic Kit
instructions on the next page.
23
Diagnostic Kit Instructions
Start HERE if the
leak is found AFTER
the prosthesis has
been delivered.
Follow this process to evaluate the integrity of the
LimbLogic VS prior to fitting or to isolate the source
of a leak in the system.
Have the patient don the prosthesis:
•fold down the top edge of the Alpha Liner
•use a latex sleeve from the kit instead of
the Alpha Flex.
Activate the vacuum.
The Alpha
Flex was the
source of the
leak.
If the leak
goes away
If the leak does NOT go away
For a LAMINATED
socket
Start HERE if the
leak is found BEFORE
the prosthesis has
been delivered.
If the leak
goes away
The leak
was coming
through the
socket walls.
Laminate a
new socket
with an inner
layer of
PETG.
Press the Suction
Pad against the
proximal surface of
the distal adapter
with the dome side
facing down.
Activate the vacuum.
For a THERMOPLASTIC
socket
Press the Suction
Pad against the
proximal surface of
the distal adapter
with the dome side
facing up.
Activate the vacuum.
If the leak does
NOT go away
Renove the pump from the socket. Use the Diagnostic
Disc that is included with every pump to see if the leak is
coming from the pump:
• Remove the protective tape from the Diagnostic Disc.
• Place the Proximal Gasket in the recess on top of the
pump.
• Place the Diagnostic Disc on top of the Proximal
Gasket.
• Attach the pump with the Diagnostic Disc and
Proximal Gasket to the socket.
• Start the pump and make sure the vacuum does not
bleed off.
If the leak does
NOT go away
•Make sure that there are two
Proximal Gaskets in place
between the pump and the
themoplastic socket.
•Make sure that the four M6
screws are tightened to 9
ft-lbs or 12 Nm.
•Make sure that the internal
surface of the thermoplastic
socket is flat and free of
defects.
If the leak goes away
The leak is coming from where the socket meets the pump. Possible causes:
• The 4-Hole Distal Adapter was not attached to the socket using Fabtech 60 structural
urethane.
• The pump was installed with the wrong bolts. If the 55 mm bolts for the thermoplastic
adapter were used in a laminated socket, the bolts will bottom out before they can be
appropriately tightened.
• The leak could be coming from the proximal sealing gasket. Make sure the gasket is the
one that was provided by Ohio Willow Wood. Clean with isopropyl alcohol to remove
any debris. If the gasket is torn, install a new one.
• The surface of the 4-Hole Distal Adapter and/or pump are damaged or dirty.
• The walls of the center hole could be leaking. Drill the hole out to 3/8", fill the hole
with Fabtech 60 structural urethane, then drill out a new 9/32" hole.
To confirm that you have fixed the leak:
• Reassemble the pump and gasket to the socket.
• Activate the vacuum.
24
If the leak
does NOT
go away
The leak was
coming from the
Vacuum Pump.
Contact Ohio
Willow Wood.
Technical Information
Warranty
The warranty for the LimbLogic VS is two years (allowing three weeks from
the date of purchase for installation), provided that the system is selected
according to the following criteria:
Note: The weights listed below are adjusted body weights. Adjusted
body weight is defined as the weight of the amputee plus any loads
normally or routinely carried by the amputee.
Level 1 350 lbs 160 kg Level 2 350 lbs 160 kg Level 3 350 lbs 160 kg Level 4
300 lbs
135 kg
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.
Use of the LimbLogic VS for amputees who do not meet the above criteria
or who engage in extremely high and abusive activities is against Ohio
Willow Wood’s recommendations and will void the two-year warranty.
“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.
Warranty Disclaimer
Ohio Willow Wood warrants that each product manufactured will, at
the time of delivery, be of workmanlike quality and substantially free of
defects. OHIO WILLOW WOOD 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 replacement of the products or
credit for the products. Ohio Willow Wood’s liability shall not exceed the
purchase price of the product. Ohio Willow Wood shall not be liable for
any indirect, incidental, or consequential damage.
25
Technical Information
Ohio Willow Wood Retention of Rights
Ohio Willow Wood 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.
26
Technical Information
Regulatory Information
See www.limblogic.com for detailed WEEE compliance information.
LimbLogic VS Fob
This product contains a user replaceable lithium battery. Replace
only with user replaceable CR2 batteries. Discard of discharged
batteries in accordance with local regulations. Observe polarity
markings on the battery and the fob housing when replacing the
battery.
This product complies with IEC 60601-1:1998 +A1:1991
+A2 1995, EN 300 440-1 V1.3.1:2001EMC, EN 301 4891 V1.7.1:2006, EN 301 489-3 V1.4.1:2002 EMC, and
EN55022:1998/A1:2000/A2:2003.
IEC 60601-1 Classifications:
Internally powered
Degree of protection against electrical shock – Type BF
Applied Part
In addition to the above compliances, this device complies with
EN55022:1998/A1:2000/A2:2003 Class B ITE emissions
requirements and all requirements for Low Interference
Potential Devices (LIPD) and compliance with the requirements
for a General User Licence (GUL).
27
Technical Information
LimbLogic VS Vacuum Pump
This product contains a rechargeable Lithium Ion Battery. Use
ONLY an Ohio Willow Wood charger. For LLV-01042 series
Vacuum Pumps use Ohio Willow Wood charger part number
LLV-01011. For LLV-01040 series Vacuum Pumps use Ohio Willow
Wood charger part number LLV-01010. Use of other chargers may
result in harm to the device, the user, or both and void the warranty.
Blocking or plugging the exhaust port of the vacuum control
assembly will prevent proper operation of the vacuum pump.
The LLVS Vacuum Pump is intended for use on a single patient.
Use of the system with multiple patients could lead to cross
contamination between patients. Please disinfect systems, or
return systems to The Ohio Willow Wood Company to be
disinfected, between uses on different patients.
The LLVS 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. Ohio Willow Wood does not currently
support the use of the LLVS for uses other than suspension.
Use only the bolts supplied by The Ohio Willow Wood Company.
All testing for the LLVS vacuum system has been tested with the
50mm bolts included with the system. Use of other bolts could
result in mechanical failure.
This product complies with IEC 60601-1:1998 +A1:1991 +A2 1995,
EN 300 440-1 V1.3.1:2001EMC, EN 301 489-1 V1.7.1:2006,
EN 301 489-3 V1.4.1:2002 EMC, EN55022:1998/A1:2000/A2:2003,
and CEI/IEC 60529:1989+A1:1999 rating IPX8. (3 meters for
12 hours in fresh water).
IEC 60601-1 Classifications:
Internally powered/Powered from Class II Power Supply
Degree of protection against electrical shock – Type BF
Applied Part
This product complies with the requirements of ISO 10328.
In addition to the above compliances, this device complies
with EN55022:1998/A1:2000/A2:2003 Class B ITE emissions
requirements and all requirements for Low Interference Potential
Devices (LIPD) and compliance with the requirements for a
General User Licence (GUL).
28
Technical Information
LimbLogic VS Battery Charger
This product is designed to work with Ohio Willow Wood products
specifically designed for its use. For LLV-01042 series Vacuum
Pumps use Ohio Willow Wood charger part number LLV-01011.
For LLV-01040 series Vacuum Pumps use Ohio Willow Wood
charger part number LLV-01010. Use with other products may
result in harm to the device, the user, or both and void the warranty.
Refer to product manuals to verify compatibility with this charger
before attempting to use this charger with the product.
Electrical Ratings:
Rated input: 100 – 240 Vac, 0.6 A, 47 – 63 Hz
Rated output: 5 Vdc, 2.6 A
This product complies with IEC 60601-1:1998 +A1:1991
+A2 1995.
29
Technical Information
FCC and IC Compliance Information
(for the Fob and the Vacuum Pump)
This device complies with Part 15 of the FCC Rules.
Operation is subject to the following two conditions:
1. This device may not cause harmful interference, and
2. This device must accept any interference received, including
interference that may cause undesired operation.
Note:
This equipment contains module, FCC ID U3V6221020 (IC 7475A-6221020),
which qualifies as an UNLICENSED MODULAR TRANSMITTER per
FCC Public Notice DA 00-1407 and RSS-Gen 7.1.2. It has been tested
and found to comply with Part 15.249 of the FCC Rules and RSS-210
Annex 2.9. This module has been designed for use by the Ohio Willow
Wood Co. This module shall only be designed into products by The Ohio
Willow Wood Co.
Warning:
Changes or modifications not expressly approved by The Ohio Willow
Wood Company could void the user’s authority to operate the equipment.
Required labeling:
Any device incorporating this module must include an external, visible,
permanent marking or label which states:
“Contains FCC ID U3V6221020 (IC 7475A-6221020).”
Failure to comply with this requirement will void the user’s authority to
operate any device that incorporates this module.
The LimbLogic VS is not to be used within the geographical area
within a radius of 20 km from the centre of Ny-Ålesund in Norway.
30
Technical Information
Specifications:
IC................................................
FCC ID.......................................
Input voltage...............................
Input current...............................
Operating temperature range......
Frequency range..........................
Antenna.......................................
Transmit power...........................
Communication type...................
Data rate......................................
Size.............................................
7475A-6221020
U3V6221020
4.5 -12V DC
37 mA
-20ºC to +50ºC
2400 -2483 MHz.
Permanently soldered to Module
<2mW
Frequency Hopping Spread Spectrum.
500 kbps.
1.398” x 0.897”
31
Technical Information
Electromagnetic Compatibility
Medical electrical equipment needs special precautions regarding
electromagnetic compatibility (EMC) and needs to be installed and put
into service according to the EMC information provided in this user
manual. Portable and mobile radio frequency (RF) communications
equipment can affect medical electrical equipment.
Guidance and Manufacturer's Declaration - Electromagnetic Emissions
The LLVS is intended for use in the electromagnetic environments
specified below. The customer or the user of the LLVS should assure it
is used in such an environment.
Emissions Test
Compliance
Guidance
RF Emissions
Group 2
CISPR 11
The LLVS must emit electromagnetic
energy in order to perform its
intended function. Nearby electronic
equipment may be affected.
RF Emissions
Class B
CISPR 11
Harmonic Emissions
N/A
IEC 61000-3-2
Voltage Fluctuations/
N/A
Flicker Emissions
IEC 61000-3-3
Suitable for use in all establishments,
including domestic establishments
and those directly connected to the
public low-voltage power supply
network that supplies buildings
used for domestic purposes.
32
Technical Information
Guidance and Manufacturer's Declaration - Electromagnetic Immunity
The LLVS is intended for use in the electromagnetic environments
specified below. The customer or the user of the LLVS should assure it
is used in such an environment.
Immunity
Test
IEC 60601
Test Level
Compliance
Level
Guidance
Electrostatic
± 6 kV Contact
± 6 kV Contact
Discharge
IEC 61000-4-2 ± 8 kV Air
± 8 kV Air
Floors should be wood,
concrete, or ceramic tile.
If floors are covered with
synthetic material, the
relative humidity should
be at least 30%.
Electrical Fast ± 2 kV on Power ± 2 kV on Power
Transient/Burst Supply Lines
Supply Lines
IEC 61000-4-4 ± 1 kV on Input/ ± 1 kV on Input/
Output Lines
Output Lines
Mains power quality
should be that of a
typical commercial or
hospital environment.
Surge
IEC 61000-4-5
Mains power quality
should be that of a typical
commercial or hospital
environment.
± 1 kV Differential ± 1 kV Differential
Mode
Mode
± 2 kV Common ± 2 kV Common
Mode
Mode
Voltage Dips,
< 5% UT
< 5% UT
Short Interrupts, (95% dip in UT (95% dip in UT
& Variations on for 0.5 cycles)
for 0.5 cycles)
Power Supply < 40% UT
< 40% UT
Lines
(60% dip in UT (60% dip in UT
IEC 61000-4-11 for 5 cycles)
for 5 cycles)
< 70% UT
<70% UT
(30% dip in UT (30% dip in UT
for 25 cycles)
for 25 cycles)
Mains power quality
should be that of a typical
commercial or hospital
environment. If the user
of the LLVS requires
continued operation during
mains interruptions, it is
recommended that the
LLVS be powered from
an uninterruptible power
supply or a battery.
Power Frequency 3 A/m
3 A/m
Magnetic Fields
IEC 61000-4-8
Power frequency magnetic
fields should be at levels
characteristic of a typical
location in a typical
commercial or hospital
environment.
NOTE: UT is the a.c. mains voltage prior to application of the test level.
33
Technical Information
Guidance and Manufacturer's Declaration - Electromagnetic Immunity
The LLVS is intended for use in the electromagnetic environments
specified below. The customer or the user of the LLVS should assure it is
used in such an environment.
Immunity
IEC 60601
Compliance
Test
Test Level
Level
Guidance
Portable and mobile RF
communications equipment
should be used no closer to any
part of the LLVS, including
cables, than the recommended
separation distance calculated
from the equation applicable to
the frequency of the transmitter.
Recommended separation
distance
d = 1, 2 P
Conducted RF 3 Vrms
3 Vrms
IEC 61000-4-6 150 kHz to 80 MHzd = 1, 2 P 80 MHz to 800 MHz
Radiated RF 3 Vrms
3 V/m800
MHz to 2.5 GHz
d = 2,3 P
IEC 61000-4-3
Where P is the maximum output
power rating of the transmitter
in watts (W) according to the
transmitter manufacturer and d
is the recommended separation
distance in meters (m).
Field strengths from fixed RF
transmitters, as determined by
an electromagnetic site survey,a
should be less than the compliance
level in each frequency range.b
Interference may occur in the
vicinity of equipment marked
with the following symbol:
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic
propagation is affected by absorption and reflection from structures,
objects and people.
a Field strengths from fixed transmitters, such as base stations for radio
(cellular/cordless) telephones and land mobile radios, amateur radio, AM and
34
Technical Information
FM radio broadcast and TV broadcast cannot be predicted theoretically with
accuracy. To assess the electromagnetic environment due to fixed RF transmitters,
an electromagnetic site survey should be considered. If the measured field
strength in the location in which the LLVS is used exceeds the applicable
RF compliance level above, the LLVS should be observed to verify normal
operation. If abnormal performance is observed, additional measures may be
necessary, such as reorienting or relocating the LLVS.
bOver the frequency range 150 kHz to 80 MHz, field strengths should
be less than [V1] V/m.
Recommended separation distances between portable and
mobile RF communications equipment and the LLVS
The LLVS is intended for use in an electromagnetic environment in which
radiated RF disturbances are controlled. The customer or the user of the
LLVS can help prevent electromagnetic interference by maintaining a
minimum distance between portable and mobile RF communications
equipment (transmitters) and the LLVS as recommended below, according
to the maximum output power of the communications equipment.
Rated maximum
output power
of transmitter
0.01
0.1
1
10
100
Separation distance according
to frequency of transmitter (m)
150 kHz to 80 MHz 80 MHz to 800 MHz
d = 1, 2 P
d = 1, 2 P
0,12
0,38
1,2
3,8
12
0,12
0,38
1,2
3,8
12
For transmitters rated at a maximum output power not listed above, the
recommended separation distance d in meters (m) can be estimated using the
equation applicable to the frequency of the transmitter, where P is the maximum
output power rating of the transmitter in watts (W) according to the transmitter
manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher
frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic
propagation is affected by absorption and reflection from structures,
objects and people.
35
OHIO WILLOW WOOD®
free the body...free the spirit
®
15441 Scioto Darby Road
Mt. Sterling, OH 43143
phone 740.869.3377 / 800.848.4930
fax 740.869.4374 www.owwco.com
Ohio Willow Wood Company B.V
Keizersgracht 62/64
1015 CS Amsterdam
The Netherlands
PN-2025-Q 24 JUN 2011
36
US and Foreign Patents Pending