AMS 800 User manual

AMS 800™ Urinary Control System
DAILY USE:
While the cuff is closed,
urine stays inside the bladder.
To urinate, open the cuff as follows:
Feel for the control pump in your
scrotum. Stabilize the control pump
in the proper place by grasping the
tubing above the control pump.
1
Grasp
Tubing
Control
Pump

Use the other hand to squeeze and
release the lower, softer part of the pump
several times. Repeat this step until the
pump is at. Once at, this indicates
that the cuff is deated. The urethra
is now open and you can urinate.
MR Conditional: 3.0 Tesla
AMS 800™ Urinary Control System 2
Soft
Part
Rx Only
™The denoted marks are trademarks or registered trademarks of
American Medical Systems, Inc.
© 2015American Medical Systems, Inc. All Rights Reserved.
1001248r2 02-15 www.AmericanMedicalSystems.com 1-800-328-3881
an endo international compan
y

AMS 800™ Urinary Control System
DEACTIVATING:
Squeeze and release the lower part of
the control pump several times to empty
the cuff. (The cuff is empty when the pump
remains at). Then, allow the pump bulb
to partially rell for about 30-60 seconds.
After allowing the pump bulb to partially
rell, rmly press the deactivation button
found at the top of the pump.
1

When the device is
deactivated, a slight
indentation will be felt
at the center of the
soft part of the pump.
MR Conditional: 3.0 Tesla
AMS 800™ Urinary Control System 2
Deactivation
Button
Soft Part
Rx Only
™The denoted marks are trademarks or registered trademarks of
American Medical Systems, Inc.
© 2015American Medical Systems,Inc. All Rights Reserved.
1001248r2 02-15 www.AmericanMedicalSystems.com 1-800-328-3881
an endo international compan
y

AMS 800™ Urinary Control System
ACTIVATING:
Begin by stabilizing the control
pump in the proper place by
grasping the tubing above the
control pump. Use your other
hand to rmly squeeze the sides
of the upper, hard part of the
pump for several minutes.
1
Squeeze sides of
upper, hard part

Continue stabilizing the control pump
by holding the tubing. Give the lower
part of the pump a hard, forceful squeeze.
This step may need to be repeated if
you’re not successful the rst time. The
system should now function normally.
MR Conditional: 3.0 Tesla
AMS 800™ Urinary Control System 2
Rx Only
™The denoted marks are trademarks or registered trademarks of
American Medical Systems, Inc.
© 2015 American Medical Systems, Inc. All Rights Reserved.
1001248r2 02-15 www.AmericanMedicalSystems.com 1-800-328-3881
an endo international compan
y

Table of Contents
The AMS 800™Urinary Control System...... 1
Using the AMS 800™Urinary Control System 2
Special precautions to take with your
AMS 800™Urinary Control System before
undergoing a medical procedure................. 5
Deactivating the AMS 800™
Urinary Control System .............................. 5
Activating the AMS 800™
Urinary Control System .............................. 7
When should I contact my doctor?.............. 9
Where can I get more information about
the AMS 800™Urinary Control System? ... 11
AMS 800™
Urinary Control System
User’s Guide for Male Patients

The AMS 800™Urinary Control System is
intended for use in the treatment of male
urinary incontinence. This device is not for
patients who are determined by their doctor
to be poor surgical candidates, have permanent
blockage of the lower urinary tract or who
have uncontrollable contraction of the bladder.
Some AMS 800™Urinary Control devices may
contain an antibiotic (InhibiZone™).
The AMS 800™Urinary Control System
consists of three main components: an
occlusive cuff, a control pump, and a pressure-
regulating balloon (Figure 1). These are
connected by tubing and are filled with a sterile
solution. The cuff works much like a normal
sphincter, gently squeezing the urethra (urinary
canal) closed to keep urine in the bladder.
The device may not be suited for patients
who are allergic to the antibiotics contained
within the device (rifampin, minocycline or
other tetracycline’s). Patients with urinary tract
infections, diabetes, spinal cord injuries, or skin
infections may have an increased risk of infection.
control pump
occlusive
cuff
pressure regulating
balloon (PRB)
urethra
1
The AMS 800™
Urinary Control System
Figure 1

Using the AMS 800™
Urinary Control System
While cuff is closed, urine stays inside
of the bladder.
To urinate, the cuff is opened as follows:
1. Feel for the control pump in your
scrotum (Figure 2).
2. Stabilize the control pump in the proper
place by gently grasping the tubing
above the control pump (Figure 3).
tubing
deactivation
button hard part
soft part
2
Figure 2
Figure 3

3. Use the other hand to squeeze and
release the lower, softer part of the
control pump (Figure 4). Do this several
times until the control pump is flat.
4. When the lower part of the control
pump is flat, it indicates that the fluid that
filled the cuff has moved to the pressure –
regulating balloon (PRB), deflating the
cuff (Figure 5). The urethra opens and
you can urinate.
3
Figure 4
Figure 5

That is the all the manipulation required to
urinate. The fluid automatically returns from
the PRB to refill the cuff. Once full, the cuff
again squeezes the urethra closed. It usually
takes several minutes for the cuff to be filled
by the fluid (urethra to be re-closed), but
each person is different. After using your
AMS 800™Urinary Control System a few
times, you will know how long it takes for
your cuff to refill.
If you feel that you did not empty your
bladder completely before the cuff refilled,
give the soft part of the control pump a few
more squeezes to re-open the urethra.
It is a good idea to get into the habit of
emptying your bladder on a regular basis,
such as every two to three hours.
It is important to let someone else, such
as your spouse, know how to operate the
AMS 800™ Urinary Control System to
assist you if needed.
4

Deactivating the AMS 800™
Urinary Control System
The AMS 800™Urinary Control System has a
deactivation button which stops the flow of
the fluid from one component to another.Your
doctor may deactivate your device at various
times, such as while you are healing following
your surgery or before inserting a catheter or
other instrument into your urethra.
Special precautions to
take with your AMS 800™
Urinary Control System
before undergoing a medical
procedure
It is important for healthcare providers
to know that you have an AMS 800™
Urinary Control System before you
undergo any medical procedure. This is
especially true of any procedures which
require the insertion of a catheter or
any other instrument into the urethra.
Such procedures can only be safely
performed after your AMS 800™ Urinary
Control System has been deactivated
(see the following section for deactivation
instructions). Failure to deactivate the
AMS 800™ Urinary Control System
before inserting a catheter or other
instrument into the urethra can result
in damage to the device and/or your
urethra. It is possible that such damage
could require removal of the device.
5

To deactivate the AMS 800™
Urinary Control System:
1. Squeeze and release the lower part of the
control pump several times, just as you
would do to urinate.
2. After completely emptying the cuff (the
cuff is empty when the pump remains
flat), allow the pump bulb to partially
refill (about 30-60 seconds). When the
control pump is partially refilled, firmly
press the deactivation button on the top
of the control pump. After pressing the
deactivation button, you will still feel the
button on the upper part of the pump.
Pressing the deactivation button locks out
the flow of fluid through the control pump.
When the device is properly deactivated, a
slight indentation will be felt at the center
of the soft part of the pump. The cuff will
now remain open (Figure 6).
When the
AMS 800™Urinary Control System
is deactivated, the cuff around your urethra
will not stop the flow of urine. You should
use pads while the AMS 800™ Urinary Control
System is deactivated.
What happens if the deactivation button
is squeezed accidentally? The device will
deactivate and two problems could occur.
6
Figure 6
deactivation
button

Fluid may not refill the cuff, so you will keep
leaking urine, or fluid may lock in the cuff so
you cannot urinate. If either problem occurs,
you will notice that the pump feels different
from its normal status. You can activate the
device to solve these problems.
Activating the AMS 800™
Urinary Control System
It is important that the AMS 800™Urinary
Control System remain open while you are
healing following your surgery. Closely follow
your doctor’s instructions about the amount
of time before activating the device.
To activate the AMS 800™
Urinary Control System:
1. Use one hand to grasp the tubing above
the control pump to hold the control
pump in an appropriate place (Figure 7).
2. Use the other hand to squeeze the sides of
the upper, hard part of the control pump,
on the side opposite the deactivation
button. Be sure to use steady, firm pressure
for several minutes. This will cause the
lower part of the control pump to become
hard and filled with fluid.
7
Figure 7

3. Continue stabilizing the control pump
by holding the tubing (DO NOT STABILIZE
THE PUMP BY HOLDING THE UPPER,
HARDER PART OF THE PUMP DURING
THIS STEP. DOING SO WILL MAKE
PROPER ACTIVATION EXTREMELY
DIFFICULT). Give the lower part of the
pump a quick, forceful squeeze (Figure 8).
This step may need to be repeated if you’re
not successful the first time. Because greater
pressure is required for activation than for
normal operation, you may experience some
discomfort while activating the device.
The system should now function normally.
8
Figure 8

When should I contact my doctor?
Contact your doctor if you notice any of
the following:
• Fever
• Swelling near the incision
• Redness near the incision
• Any other signs of infection
• If the surgical area does not heal
• Prolonged pain or discomfort
• If the device can be seen or felt outside
of the skin
• Return of leakage
• If the device is not working correctly
9

Where can I get more information about
the AMS 800™Urinary Control System?
Your doctor is the best source for getting
more information on the AMS 800™Urinary
Control System. Your doctor is most familiar
with your medical situation and can work
with you to make sure you get the best
possible results from the AMS 800™ Urinary
Control System. Contact your doctor if
you have questions or would like to receive
additional information.
You can also call the AMS patient liaison at
1-800-328-3881, extension 6261, or visit our
website at www.AmericanMedicalSystems.com.
10

Rx Only
™ The denoted marks are trademarks or registered
trademarks of American Medical Systems, Inc.
© 2013 American Medical Systems, Inc.
All Rights Reserved. Printed in USA.
600334-01G/August 2013
American Medical Systems, Inc.
U.S. Headquarters
10700 Bren Road West
Minnetonka, MN 55343
USA
U.S. Toll Free: 800-328-3881
Tel: + 952 930 6000
Fax: + 952 930 6157
www.AmericanMedicalSystems.com
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Europe B.V.
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Tel: [phone]
[email protected]