WillowWood LimbLogic User manual
1
LimbLogic®
Patient
Instructions
LimbLogic uses air pressure and a sealing system
to suspend your prosthesis.
The system includes a fob that gives you remote
control of the vacuum level.
Please read these instructions thoroughly.
Contact your prosthetist if you have any
questions.
2
The following information is required by law. If you are not familiar
with these concepts, please discuss them with your prosthetist.
There are no field-serviceable parts inside the
Vacuum Pump. Opening the Vacuum Pump or
charger may result in injury or death and will
void the warranty.
Unauthorized changes or modifications to the
LimbLogic 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 Vacuum Pump.
This may impair function of your vacuum system.
Do not allow acetone to contact the Vacuum Pump or fob.
All LimbLogic components have passed safety
testing for use as medical devices. Radio enabled
devices comply with United States and international
guidelines for low power transceivers. If LimbLogic
components will be used around safety critical
devices such as pacemakers or defibrillators, consult
the manufacturer for appropriate usage instructions.
Failure to do so may result in injury or death. Consult
the section on Regulatory Information for more
information on safety and compliance.
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.
Charge the Vacuum Pump in a well-ventilated area
at a temperature between 5 °C (41 °F) and 33 °C
(90 °F). Failure to do so may result in prolonged or
incomplete charging of the Vacuum Pump and
may damage the Vacuum Pump.
A Vacuum Pump enclosed by a cosmetic cover will
retain heat, but in most cases should charge
normally at temperatures below 27 °C (80 °F). The
battery may not fully charge at higher temperatures.
Use of the LimbLogic at temperatures above 41 °C
(106 °F) may heat the surface of the product to
unsafe temperatures which could cause burns with
extended contact. Use care when operating the
LimbLogic at high temperatures.
LimbLogic has been constructed using polymer
materials to create a durable, lightweight, water-
tight, and radio-transparent design. These materials
have all been certified to an inflammability rating of
at least HB per UL 94. However, polymers can melt
or burn if exposed to high temperatures or flame.
Do not expose your LimbLogic product to these
conditions. Doing so may result in ignition resulting
in injury or death.
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.
Electrical equipment can interact. Do not operate
the fob, charger, or either LimbLogic pump design
while they are stacked upon, or in close proximity
to, other electrical equipment without monitoring
performance. Doing so may result in equipment
malfunction or failure.
3
Contact your prosthetist if you develop rashes or other
reactions after contact with LimbLogic components.
The Side Mount LimbLogic Vacuum Pump has been
designed and tested for mounting on transfemoral
sockets. Use in other configurations may result in
tripping or other hazards.
FCC NOTICE
Note:
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.
Changes or modifications not approved by The Ohio Willow Wood
Company may degrade performance, possibly leading to injury or
death and will void the user’s authority to operate this equipment.
IC Notice
Note:
This device complies with Industry Canada RSS standards
applicable to radio devices. Operation is subject to the following
two conditions: (1) this device may not cause interference, and (2)
the user of the device must accept any interference, including
interference that may cause undesired operation.
Remarque:
Le présent appareil est conforme aux CNR d‘Industrie Canada
applicables aux appareils radio . L‘exploitation est autorisée aux
deux conditions suivantes: (1) l‘appareil ne doit pas produire
de brouillage, et (2) l‘utilisateur de l‘appareil doit accepter tout
brouillage radioélectrique subi, même si le brouillage est
susceptible d‘en compromettre le fonctionnement.
4
TABLE OF CONTENTS
Page
Installing the Fob Battery ..........................................................................5
Quick-Start Guide ........................................................................................ 6
Fob Guide ....................................................................................................... 6
Charging the Vacuum Pump Battery ....................................................7
Charging the Vacuum Pump Battery Outside the U.S....................8
Charging the Vacuum Pump Battery in a Vehicle ............................8
Turning On the Vacuum Pump................................................................ 9
Turning O the Vacuum Pump ............................................................... 9
Resetting the Vacuum Pump................................................................... 9
Turning On the Fob ..................................................................................... 9
Changing Vacuum Set Point...................................................................10
Changing Pump State ...............................................................................10
Bilateral Indicators....................................................................................... 11
Detecting a Leak ......................................................................................... 12
Vacuum Pump Battery Status................................................................ 12
Exposure to Water...................................................................................... 12
Exhaust Tube Muer Cleaning.............................................................. 13
Potential Home Use Challenges ........................................................... 13
Service Life.................................................................................................... 13
Troubleshooting Guide .............................................................................14
Regulatory Information............................................................................. 18
5
Overview
INSTALLING THE FOB BATTERY
The fob uses a coin cell battery. The type is CR2032. The battery
that is shipped with the system must be installed prior to using the
fob.
The battery will normally have to be replaced every 3 months.
Pry open the fob case with a small flat blade screwdriver. To
snap it back together, start at the battery end and work back
toward the opposite end.
The fob battery could cause serious injury or death
including choking. Keep coin cell type batteries away
from children.
After you replace the battery, all of the LED indicators
should light up. If they do not, the battery might be
upside-down. Otherwise, either the battery or the LEDs
are not working.
6
Overview
QUICK-START GUIDE
To resume vacuum regulation:
2. Turn on the fob.
1. Turn on the Vacuum Pump.
Press one time.
Pump will beep once.
Wait 10 seconds.
FOB GUIDE
Current
Vacuum
Level
Bilateral Indicators
Standby/
Adaptive
Indicator
(White)
Leak
Indicator
(Red)
Up
Enter
Down
Vacuum Pump Battery Indicator
50-100%
30-50%
20-30%
< 20%
Press and hold the center button The yellow
numbers will flash in a “chasing” pattern.
Then they will display the current vacuum
level. Release the button.
The pump is now Active. The pump will
operate until the desired vacuum level is
reached.
Press for about 2 seconds.
The chasing pattern will be displayed.
The pump returns to Active State.
3. To enter Standby Sate:
Press for about 2 seconds.
The chasing pattern will be displayed,
then the white Standby Indicator will light.
6. Turn o the Vacuum Pump.
Press one time.
Pump will beep either two
or four times to indicate
its configuration. Talk to
your prosthetist if you have
questions.
7
CHARGING THE VACUUM PUMP BATTERY
Charge the Vacuum Pump before it is used for the first time.
Also charge it at the end of each day of use, and when the
Battery Indicator on the fob is red.
1. Charge the Vacuum Pump in a well-ventilated area between
5 °C (41 °F) and 32 °C (90 °F). Charging outside of this
range may damage your Vacuum Pump. It may also result in
prolonged or incomplete charging.
The following information is required by law. If you are not
familiar with these concepts, please discuss them with your
prosthetist.
Only charge the Vacuum Pump in a well ventilated
area at a temperature between 5 °C (41 °F) and 32 °C
(90 °F). Charging outside of these conditions may
damage the Vacuum Pump.
A Vacuum Pump enclosed by a cosmetic cover will
retain heat, but in most cases should charge normally
at temperatures below 27 °C (80 °F). The battery may
not fully charge at higher temperatures.
2. Insert the charging plug all the way into the charging port.
3. Plug the Charger into a power outlet. The Adapter LED will
light. If the Node LED does not light, make sure you have
inserted the charging plug all the way into the port.
If the Node LED is red, reset the Charger by unplugging it
from the wall and plugging it back in.
While charging is in progress, the Node LED will be solid.
The battery indicator on the fob will flash between red and
green.
4. When charging is complete, the Node LED will flash.
Disconnect the Charger from the Vacuum Pump and from
the power outlet.
When you are ready for the pump to begin regulating the
vacuum, either turn on the fob (refer to page 9) or press the
on/o button on the Vacuum Pump. The pump will run until the
preselected vacuum level is reached.
Note: Your pump can be used while charging. If the pump has
just been unplugged from the Charger, it will be in Standby State
(refer to page 10). To resume vacuum regulation, press the on/o
button one time for Active State. Press again to turn the pump o.
Do NOT walk while charging your LimbLogic. You may trip
and fall.
Use ONLY a WillowWood Charger. Use of any other charger
may result in damage to the Vacuum Pump or the charger
or both and may negatively aect EMC performance and/or
compliance and may result in serious injury or death.
The charger may pose both a strangulation and/or
electrocution hazard and should not be handled by children.
Do not use the Charger near water. The Charger is not
waterproof. Use of the charger near water may result in
serious injury or death.
Overview
Node LED
(indicates Charger function)
RED = fault
SOLID = charging
FLASHING = charged
Flashing:
Charged
13.8 0V
LLV-21011
solid:
Charging
2012 PN-1988-H
ABN: 22582837497
Charger To AC outlet
charging plug Adapter LED
(indicates that
AC outlet is
providing power
to Charger)
Node LED AC Adapter
Vacuum Pump
charging port
8
CHARGING THE VACUUM PUMP BATTERY OUTSIDE THE
UNITED STATES
Chargers sold for use outside the U.S. come with a set of prong
adapters. These adapters allow you to use the Charger in many
countries.
The following information is required by law. If you are not
familiar with this concept, please discuss it with your prosthetist.
Plugging a prong set into an outlet without the
Charger may expose you to dangerous voltages
potentially leading to injury or death. Always
plug the prong set into the Charger before plugging
the Charger or the prong set into an outlet.
CHARGING THE VACUUM PUMP BATTERY IN A VEHICLE
To charge the Vacuum Pump in a vehicle, you need a Power
Inverter. The Power Inverter must be rated at 75 Watts or less.
Example:
• Digital Concepts™ 75 Watt Portable Power Inverter
(available from general retailers)
1. Plug the Power Inverter into the car’s 12V DC socket.
2. Connect the Charger to the Vacuum Pump.
3. Plug the Charger into the Inverter.
Do not operate the Charger above 41 ˚C (105 ˚F).
The battery may not fully charge at higher temperatures.
Overview
The battery will power the pump for at least a full 18 hour day
of normal usage. It will do so for the life of the product. (Refer
to “Service Life” on page 13.) If it is unable to do so, please refer
to page 14 or call your prosthetist.
9
TURNING OFF THE VACUUM PUMP
Press the on/o button on the Vacuum Pump and hold for
1 second. The pump will beep several times to indicate that it
has been turned o. Refer to the Quick-Start Guide (page 6) for
more information.
Note: if the pump has just been unplugged from the Charger, it
will be in Standby State (refer to page 10). To resume vacuum
regulation, press the on/o button one time for Active State.
Press again to turn the pump o.
RESETTING THE VACUUM PUMP
The pump may stop working if it is exposed to static electricity. If
this happens, press the on/o button on the pump and hold for at
least 12 seconds until the unit beeps. You may also need to reset
the pump when the fob displays certain error codes (see page 17).
TURNING ON THE FOB
Make sure the pump is on has been on for at least 10 seconds.
Press and hold the Enter (center) button. After about 2 seconds the
yellow numbers will flash in a “chasing” pattern. The chasing pattern
means that the fob is trying to communicate with the pump.
When the fob connects to the pump, the current vacuum level
will be displayed in the center. A connected fob will shut o after
one minute of non-use.
If the pump is o or does not connect to the fob, the chasing pat-
tern will end after 6 seconds. All of the LEDs on the fob will turn o.
If you have a pump on each leg, the fob will try to communicate
with the first pump, followed by the second pump. If the fob
cannot communicate with either pump, the fob will shut down.
Enter
Current
vacuum level
Overview
TURNING ON THE VACUUM PUMP
Press the on/o button on the Vacuum Pump one time. The
Vacuum Pump will beep once.
Before turning on the fob wait 10 seconds for the pump to activate.
on/o button on/o button
10
CHANGING VACUUM SET POINT
Make sure that the fob is on that the yellow numbers are
showing the current vacuum level.
Press the Up or Down button for 1 second until the yellow
numbers flash. The flashing numbers indicate that the Vacuum
Set Point is being changed.
Adjust the Vacuum Set Point as follows:
• Press the Up or Down button again and again to change
the Vacuum Set Point by one number at a time.
or
• Press and hold the Up or Down button until the desired
Vacuum Set Point is displayed.
Press the Enter button to apply the changes. The “chasing”
pattern will be displayed while the setting is being applied. If
the Enter button is not pressed, the settings will not be applied.
The fob will shut o due to inactivity in 60 seconds.
CHANGING PUMP STATE
Make sure the fob is on and displaying the current vacuum level.
When the pump is on, it has two usage states.
Active: The pump turns on as needed to maintain the
vacuum level.
Standby: This allows you to turn the pump o temporarily.
Press and hold the Enter button to toggle the vacuum pump
between these two states. The “chasing” pattern will be
displayed while the change is being applied.
The white Standby indicator will light up as follows.
Not lit: Active
Lit: Standby
Enter
Standby/Active
Indicator
Overview
Enter
Current
vacuum level
Up
Down
11
If the pump detects a leak, the red Leak Indicator lights up.
Also, the pump enters Standby State and beeps 10 times rapidly.
The beeps repeat every 30 seconds unless you press the on/o
button on the pump. The beeps will stop after 6 minutes.
To return to Active State,press and hold the Enter button.
BILATERAL INDICATORS
If you have a pump on each leg, the white light on the top left
of the fob lights up when the fob is controlling the left pump.
The white light on the top right of the fob lights up when the
fob is controlling the right pump.
To control the other pump, press and hold the Up and Down
buttons together for about 1 second. While the fob tries to
connect with the other pump, the “chasing” pattern lights up and
the white lights alternate.
If the fob connects to the other pump, the fob functions like it
would for a one-pump system.
If the fob does not connect to the other pump, the fob will
return to controlling the first pump.
Up
Bilateral
Indicators
Down
Leak
Indicator
Enter
Overview
12
DETECTING A LEAK
If the pump detects a leak, the red Leak Indicator
will light up. Also, the system will enter Standby State.
At this time, the pump will make 10 short beeps. The beeps
repeat every 30 seconds unless you press the on/o button on
the pump. The beeps will stop after 6 minutes.
If the Leak Indicator lights up just after you put on your
prosthesis, restart the pump.
If the Leak Indicator lights up often while you are walking, call
your prosthetist.
To start the pump again after a leak was detected, press the
on/o button on the pump one time. Another option is to press
the Enter button on the fob.
VACUUM PUMP BATTERY STATUS
When the pump battery is charging, this light flashes between
red and green.
The level of charge is described below.
• Solid green: pump battery is charged more than 50% but
less than 100%.
• Flashing green: pump battery is charged more than 30%
but less than 50%.
• Solid red: pump battery is charged more than 20% but less
than 30%.
• Flashing red: pump battery is less than 20% charged. The
battery should be charged when possible. The pump will
shut down when the battery level reaches 0%.
• At 10% the pump will start to beep 3 times every 30
seconds. This will repeat for 6 minutes unless you press the
on/o button on the pump.
EXPOSURE TO WATER
You may place the Vacuum Pump in 10 feet (or 3 meters) of
fresh water for up to 12 hours. Do not submerse the Vacuum
Pump in salt water. Do not submerse the Vacuum Pump in
corrosive liquids. Be sure to dry o the Vacuum Pump if it is
exposed to rain or other moisture.
The fob and Charger should not be exposed to water or other
liquids. If your fob is damaged by water, call your prosthetist
for a replacement. You can continue to use your LimbLogic by
simply turning it on and o with the push button.
Leak
Indicator
Vacuum Pump
Battery Indicator
Overview
13
EXHAUST TUBE MUFFLER CLEANING
Using a flat blade screwdriver, remove the Exhaust Tube Fitting
from the pump housing. Do not lose the o-ring from the fitting.
Clear the clog in the tube by running water or by gently blowing
compressed air through the tube.
If you cannot clear the clog, ask your prosthetist for a
replacement Exhaust Tube.
Overview
Muer
Cut here
Exhaust Tube Fitting
Exhaust Tube Fitting
Exhaust Tube Fitting
If the pump must be used before the replacement tube can be
installed:
1. Remove the existing tube from the Exhaust Tube Fitting.
2. Cut the existing tube just past the Muer.
3. Connect the Exhaust Tube Fitting to the section of tube that
does not have the Muer. The pump will function normally, but
at a slightly higher noise level.
POTENTIAL HOME USE CHALLENGES
Your pump, fob, and charger are unlikely to be damaged by
exposure to lint, dust, or light. However, it is best not to charge
the pump while it is sitting in direct sunlight or near a furnace.
This might heat the pump enough to prevent it from obtaining a
full charge.
You can clean your pump by wiping it with a damp cloth. Use
only water.
Do not allow children or pets to play with your LimbLogic or its
accessories. They are designed to be durable, but they may be
damaged if exposed to rough handling such as chewing.
SERVICE LIFE
The LimbLogic pumps are designed for a reliable service life of at
least two years.
14
Overview
continued on next page
Problem Action
The pump does
not beep when
the on/o button
is pressed and
the Charger is
not connected to
the pump.
• Thepump’sinternalbatterymaynot
be charged. Charge the pump with the
Charger for at least 30 minutes and try
again.
• Theon/obuttoncouldbedamaged.
Verify that the rubber boot is intact
and hasn’t been torn from impact.
Contact your prosthetist if the switch
needs to be replaced.
• Thepumpmayhavebeenexposedto
a large static charge. Press and hold
the on/o button on the pump until
you hear a beep (about 12 seconds).
Pressing the
pump button
does not start
the pump.
• Thepump’sinternalbatterymaynot
be charged. Charge the pump with the
Charger for at least 30 minutes and try
again.
• Thepumpmayhavebeenexposedto
a large static charge. Press and hold
the on/o button on the pump until
you hear a beep (about 12 seconds).
• Thepumpmaybepartiallystalled.
Refer to the “Pump Stall” error code
information on page 17.
Pump battery
does not
maintain charge
for a full day.
• Ensurethatthesystemisproperly
sealed.
• Ensurethatthebatteryhasbeen
charged for at least 4 hours.
• Thepumpmayhavebeenexposedto
a large static charge. Press and hold
the on/o button on the pump until
you hear a beep (about 12 seconds).
• Ensurethatyoursocketdoesnotleak
excessively.
• Make sure that the charger plug stays
fully inserted during charging. The rubber
ring has been tested to last the life of
your product. However, if the plug is too
loose, replace the rubber ring.
The pump makes
a “zip zip zip”
sound as it
controls the
vacuum.
Call your prosthetist.
Pressing the
center button of
the fob does not
cause the yellow
LEDs to light in a
“chasing”
pattern.
The battery is likely dead and must be
replaced per the instructions on page 5.
TROUBLESHOOTING GUIDE
15
Overview
Problem Action
When the
vacuum level
in your socket
changes, the yel-
low numbers on
the fob do not
change.
Call your prosthetist.
The fob does not
communicate
with the pump.
The “chasing”
pattern of LEDs
ends after 6
seconds, and the
LEDs turn o.
• Waitoneminuteforthefobscreento
turn o. Make sure the pump is on by
pressing the on/o button and verify
that the pump beeps once. Listen for
about 30 seconds to make sure that the
pump doesn’t quickly beep several times
and turn o. (If it does, there is a battery
problem.) Press the fob center button
again.
• Thefobmaybetoocloseortoofar
from the pump. Place the fob about
2 feet away from the pump, and press
the fob center button again.
• Thepump’sinternalbatterymaynot
be charged. Charge the pump with the
Charger for at least 30 minutes and try
again.
• Thepumpmayhavebeenexposedtoa
large static charge. Press and hold the
on/o button on the pump until you
hear a beep (about 12 seconds).
• Doyouhavethecorrectfob-pump
combination? The fob and pump are
electronically matched. Ask your
prosthetist to call WillowWood with the
serial numbers of the fob and the pump.
WillowWood will verify that the set is
matched.
The Adapter
LED on the
Charger does
not illuminate
when plugged
into the wall.
• TheACelectricitytothewalloutlet
may not be turned on. Try plugging the
Charger into a dierent wall outlet.
• Theprongmaynotbeseated
properly in the back of the Charger’s
AC Adapter. Unplug the Charger from
the AC outlet. Remove the Charger’s
prong using the sliding latch on the
back of the adapter. Make sure that the
metal contacts are springy. Also make
sure that the contacts are not com-
pletely flat against the adapter.
Re-install the plug prongs.
• Iftheproblempersists,callyour
prosthetist.
continued on next page
16
Problem Action
The Node LED
on the Charger
does not light
or blink when
the Charger is
plugged into
vacuum pump
and AC outlet.
Call your prosthetist.
The Node LED
is red.
Reset the Charger by unplugging it from
the wall, waiting ten seconds, and then
plugging it back in.
The pump runs
repeatedly.
Using a flat blade screwdriver, remove the
Exhaust Tube Fitting from the pump
housing. Do not lose the o-ring from the
fitting. Install the drain tube and flush the
system with alcohol.
The pump beeps
but does not run.
The Muer on the Exhaust Tube may be
clogged. Clean the Muer as described on
page 13.
Overview
SUPPORT
If you cannot fix a problem using this guide, call your
prosthetist.
Under normal conditions, you should not need to rinse or sanitize
your pump. If your pump starts to smell, or if you suspect
contamination, call your prosthetist.
If you have other questions, call your prosthetist.
17
Error Codes
Sometimes the pump detects an error that it cannot fix on its
own. When this happens, the fob display switches between “Er”
and a two-digit error code. Refer to the chart below for a list of
these codes and the action required for each code.
Overview
Problem Description Cause Action
01 Pump stall Possibly
debris or
lubricant
stuck in
pump
Call your
prosthetist.
02 Temp out of
range
Pump
operation
attempted
at a
temperature
less than
-20˚C or
greater than
50˚C
Allow pump
temperature to
return to
operating range.
Then press and
hold the pump’s
on/o button for
about 12 seconds
until you hear a
beep.
03 Motion fail Motion
sensor failure
Call your
prosthetist.
04 ADC fail Analog
Digital
Converter
failure
Call your
prosthetist.
05 or 09 Memory Memory
failure
Press and hold the
pump’s on/o
button for about
12 seconds until
you hear a beep.
If problem persists,
call your
prosthetist.
06 Radio BLE Radio
failure
Call your
prosthetist.
07 Vacuum Vacuum
Sensor failure
Call your
prosthetist.
08 Battery Battery
monitoring
circuit failure
Call your
prosthetist.
OPERATION AT HIGH ALTITUDE OR LOW PRESSURE
LimbLogic uses air pressure to hold on a prosthesis. There is
less air pressure at higher altitudes. The system works normally
at a height up to 1700 meters*. Above 1700 meters*, the system
might act like it is leaking. If this happens, lower your vacuum
setting. Try a setting of 17. This usually works up to a height of
3000 meters**.
*1700 meters = 5500 feet
**3000 meters = 10000 feet
18
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.
You may place the LimbLogic pump in 10
feet (or 3 meters) of fresh water for up to
12 hours. Your fob and charger are not
resistant to water. The design is meant to
keep fingers or similar objects outside of
the pump, charger, and fob.
Adjacent to Manufacturers name and
address.
This product complies with applicable
standards for sale and use in EC countries.
This device operates on up to 7 volts of
AC and DC current.
Type BF applied part.
On/O button. Push-Push style.
This product contains an RF transmitter.
This device enclosure is manufactured
with an acetal polymer.
This product is compliant for sale in
Australia and New Zealand.
Year of manufacture.
REGULATORY INFORMATION
Return this product to the factory for proper disposal.
Essential performance:
The LimbLogic fob, charger, and side mounted pump perform no
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.
The following information is required by law. If you are not familiar
with these concepts, please discuss them with your prosthetist.
Technical Information
19
Technical Information
LimbLogic Fob
This product contains a user replaceable lithium battery.
Replace only with user replaceable CR2032 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: EN 60601-1-2:2007, IEC
60601-1-11:2010, IEC 60601-1-6:2010, IEC 60601-1-2 ED.
3.0, and IEC 60601-1:2005 +CORR.1(2006) + CORR. 2
(2007).
IEC 60601-1 Classifications:
Internally powered
Degree of protection against electrical shock –
Type BF Applied Part
In addition to the above compliances, this device com-
plies 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).
LimbLogic Vacuum Pump
This product contains a rechargeable Lithium Ion
Battery. Use ONLY a Willow Wood Charger. 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 LimbLogic 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 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 for uses other than suspension.
Use only the bolts supplied by WillowWood. All testing
for the LimbLogic vacuum system has been tested with
the bolts included with the system. Use of other bolts
could result in mechanical failure.
LimbLogic has been constructed using polymer
materials to create a durable, lightweight, watertight,
and radio-transparent design. These materials have all
been certified to an inflammability rating of at least HB
per UL 94. However, polymers can melt or burn if
exposed to high temperatures or flame. Do not
expose your LimbLogic product to these conditions.
Do not expose your LimbLogic product to these
conditions. Doing so may result in ignition resulting in
injury or death.
This product complies with: EN 60601-1-2:2007, IEC
60601-1-11:2010, IEC 60601-1-6:2010, IEC 60601-1-2 ED. 3.0,
IEC 60601-1:2005 +CORR.1(2006) + CORR. 2 (2007), CEI/
IEC 60529:1989+A1:1999 rating IP28, and ISO 10328:2005.
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 require-
ments for a General User Licence (GUL).
20
Technical Information
LimbLogic Battery Charger
This product is designed to work with WillowWood
products specifically designed for its use. Use Willow-
Wood charger part number LLV-21011. Use with other
products may result in harm to the device, the user, or
both, may void the warranty, and may negatively aect
EMC performance and/or compliance. 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: 13.8 Vdc, 2.6 A
This product complies with: EN 60601-1-2:2007, IEC
60601-1-11:2010, IEC 60601-1-6:2010, IEC 60601-1-2 ED.
3.0, and IEC 60601-1:2005 +CORR.1(2006) + CORR. 2
(2007) and meets the “ICNIRP GUIDELINES FOR
LIMITING EXPOSURE TO TIME-VARYING ELECTRIC
AND MAGNETIC FIELDS (1 HZ – 100 kHZ):2010”.
FCC AND IC COMPLIANCE INFORMATION
FOR THE SIDE MOUNT PUMP
This equipment contains:
FCC ID U3V-LLV21011
and module FCC ID XDULE40-S2
Module IC: 8456A-LE4S2
Cet équipement contient:
Module d’émission IC: 8456A-LE4S2
FOR THE DISTAL MOUNT PUMP
This equipment contains:
FCC ID U3V-LLV21011
and module FCC ID XDULE40-S2
Module IC: 8456A-LE4S2
Cet équipement contient:
Module d’émission IC: 8456A-LE4S2
FOR THE FOB
Module FCC ID XDULE40-S2
Module IC: 8456A-LE4S2
Cet équipement contient :
Module d’émission IC: 8456A-LE4S2
FOR THE CHARGER
This equipment contains:
FCC ID U3V-LLV21011
IC: 7475A-21011
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.
Radio Frequency Interference Statement
This is a Class B product. In a domestic environment, this prod-
uct may cause radio interference in which case the user may be
required to take adequate measures.
Note:
This equipment has been tested and found to comply with the limits for a
Class B digital device, pursuant to part 15 of the FCC Rules. These limits are
designed to provide reasonable protection against harmful interference in
a residential installation. This equipment generates, uses and can radiate
radio frequency energy and, if not installed and used in accordance with
the instructions, may cause harmful interference to radio communications.
However, there is no guarantee that interference will not occur in a particu-
lar installation. If this equipment does cause harmful interference to radio or
television reception, which can be determined by turning the equipment o
and on, the user is encouraged to try to correct the interference by one or
more of the following measures:
— Reorient or relocate the receiving antenna.
— Increase the separation between the equipment and receiver.
— Connect the equipment into an outlet on a circuit dierent from that
to which the receiver is connected.
— Consult the dealer or an experienced radio/TV technician for help.
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3
Table of contents
Other WillowWood Medical Equipment manuals
