Procedimento Implante AMS 700 CX

InProcess700GlobalOrm.
qkd 7/22/04 12:53 PM Page 1
Operating
Room Manual
AMS 700 ™
Penile Prosthesis
InProcess700GlobalOrm.qkd 7/22/04 12:53 PM Page 2
TABLE OF CONTENTS
INTRODUCTION
Overview 1
DEVICE DESCRIPTION
Cylinders 2
Pump 2
Reservoir 2
AMS 700 CX Prosthesis 3
AMS 700 CX Preconnect Prosthesis 3
AMS 700 CXR Preconnect Prosthesis 3
AMS 700 CXM Prosthesis 4
AMS 700 Ultrex Prosthesis 4
AMS 700 Ultrex Preconnect Prosthesis 4
DEVICE STERILIZATION AND STORAGE
Sterilization 5
AMS Tools 5
Storage 5
OPERATING ROOM INSTRUCTIONS
Preoperative Setup 6
Equipment Preparation 7-11
Prepare AMS Components 8-11
SURGICAL PROCEDURES
Prepare Patient 12
Surgical Approaches 12-13
Make Incision and Dissect 12-13
Dilate and Measure 13
Select Appropriate Size Cylinder 14
Insert Cylinders 15-16
Complete Inflate/Deflate Test 16
Implant Reservoir 17
Complete Back Pressure Test 18
Implant Pump 18
Complete Surrogate Reservoir Test 19
Connect Tubing 19
AMS Quick Connect Sutureless Window Connectors 20
Suture Tie Connectors 21
Complete Final Inflate/Flat Test 22
POSTOPERATIVE PROCEDURES
Immediately Postoperative 23
After the Patient is Released From the Hospital 23
Evaluating Long-Term Function and Placement 23
COMBINING COMPONENTS OF DIFFERENT MODELS
Interchanging AMS 700 CX Components with 24
AMS 700 Ultrex Components
TROUBLESHOOTING
Cylinders 25
Reservoirs 25
Pump 25
PRODUCT LINE MATRIX
AMS 700 Penile Prosthesis Product Line Matrix 26
APPENDIX
InhibiZone™ Surface Treatment and Parylene Coating 27
INTRODUCTION
OVERVIEW
The American Medical Systems (AMS) 700™ Penile Prosthesis Product
Line includes the following implantable prosthetic devices:
✔ AMS 700 CX™ Penile Prosthesis

✔ AMS 700 CX™ Preconnect Penile Prosthesis
✔ AMS 700 CXR Penile Prosthesis
✔ AMS 700 CXR Preconnect Penile Prosthesis
✔ AMS 700 CXM™ Penile Prosthesis
✔ AMS 700 Ultrex™ Penile Prosthesis Figure 1-1. AMS Penile Prosthesis
✔ AMS 700 Ultrex Preconnect Penile Prosthesis
™
Reservoir
All configurations are available with InhibiZone™ Antibiotic Surface
Treatment, which is an antibiotic surface treatment of rifampin
(rifampicin) and minocycline.
The AMS 700 Penile Prostheses are totally implantable, closed

fluid-filled system (Figure 1-1) consisting of:
• Two cylinders Cylinder
• One pump
(either AMS 700 Tactile Pump or AMS 700 standard pump)
• One fluid reservoir Pump Bulb
The reservoir stores the fluid that fills and expands the penile
cylinders. The patient operates the pump to inflate or deflate the Figure 1-2. System Inflation
system. The cylinders are inflated by multiple squeezes of the pump,
which transfers fluid from the reservoir. This makes the penis erect
(Figure 1-2). The cylinders are deflated by pressing and holding the
release valve. This transfers fluid back into the reservoir making the
penis flaccid (Figure 1-3). All components are connected by kink-
resistant tubing (KRT).
Pump
For warnings, precautions and contraindications please refer to the Release Valve
Package Insert provided in the product package.
Figure 1-3. System Deflation
-1-
DEVICE DESCRIPTION
CYLINDERS KRT
PTFE Traction
Each cylinder kit (Figure 1-4, Figure 1-4a) consists of: Suture
• Two silicone cylinders with:
- Solid silicone elastomer inner tube with Parylene coating
inside and outside (provides wear protection)
- Woven stretch fabric cylinder (between inner/outer tubes)
- Solid silicone elastomer outer tube with Parylene Cylinder
coating inside (provides wear protection)
• One silicone, kink resistant tube (KRT) per cylinder
• One protective PTFE (polytetrafluoroethylene) sleeve per cylinder
• One traction suture per cylinder Figure 1-4.
CX, CXM, Ultrex Penile Prosthesis: Cylinders
The cylinders come in various lengths and diameters, depending on
the model number. Rear Tip Extenders are provided in each cylinder
kit for the CX, CXM and Ultrex. They are placed over the solid rear
tip of the cylinders in a combination appropriate for the patient’s
anatomical length. For the CXR, Rear Tip Extenders are available in a
separate package. These Rear Tip Extenders are non-stackable, and
the appropriate size is selected for the patients. anatomical length.
TACTILE PUMP Figure 1-4a. CXR Penile Prosthesis: Cylinders
The pump (Figure 1-5) consists of:

• Pump bulb KRT
• Release valve
• Three silicone, kink resistant tubes (KRT)
• Internal backpressure valve
Pump
The pump is used with all AMS 700 Series cylinders. The pump is Color-Coded
Tube Bulb
only available with InhibiZone Antibiotic Surface Treatment. The
single, color-coded tubing connects the pump to the reservoir. The
pair of clear tubing connect the pump to the two penile cylinders. In
the preconnect systems, the connections between the pump and
cylinder are made at the factory. Release
Valve
RESERVOIR Figure 1-5. Penile Prosthesis: Tactile Pump
The reservoir (Figure 1-6) consists of:

• One silicone fluid storage balloon
• One silicone, color-coded kink resistant tube (KRT)
• Two size options: Balloon
- 65 ml
- 100 ml
The single, color-coded tubing connects the reservoir to the pump.

The reservoirs are available with InhibiZone Antibiotic Surface
Treatment. KRT
Figure 1-6. Penile Prosthesis: Reservoir
-2-
DEVICE DESCRIPTION (CONTINUED)
AMS 700 CX PROSTHESIS

The AMS 700 CX Prosthesis components are configured as follows:
• Pump and cylinders are not preconnect
• Reservoir: 65 ml, 100 ml
• Tactile or Standard Pump
• Cylinder diameter: 12 mm-18 mm
• Cylinder lengths: 12 cm, 15 cm, 18 cm, 21 cm
• Rear Tip Extenders: Two each—0.5 cm, 1.0 cm, 2.0 cm, 3.0 cm
• Cylinders expand only in girth
• Cylinders, reservoir and pump are available with InhibiZone
Antibiotic Surface Treatment
Cylinders
AMS 700 CX PRECONNECT PROSTHESIS
The AMS 700 CX Preconnect Prosthesis components are
configured as follows:
• Tactile Pump and cylinders are preconnected
• Infrapubic package has 18 cm tubing connecting pump
and cylinders Pump
• Penoscrotal package has 11 cm tubing connecting pump
and cylinders Reservoir
• Cylinder lengths: 15 cm, 18 cm
Reservoir Tubing
• Cylinder and pump combinations and reservoirs have
InhibiZone Antibiotic Surface Treatment Figure 1-7. AMS 700 CX Ultrex Penile Prosthesis
AMS 700 CXR PRECONNECT PROSTHESIS

The AMS 700 CXR prosthesis is designed for a patient with an
anatomy that requires shorter and narrower cylinders. It is also useful Cylinders
for penile prosthesis revision procedures.
The AMS 700 CXR Prosthesis components are configured as follows:

• Standard AMS 700 Pump and cylinders are preconnected
• Infrapubic package has 16 cm tubing connecting pump and
cylinders
• Penoscrotal package has 9 cm tubing connecting pump and Pump
cylinders
• Reservoir: 65 ml Reservoir
• Cylinder diameter: 9.5 mm-14.5 mm
• Non-stackable Rear Tip Extenders:
Two each—0.5 cm, 1.0 cm, 1.5 cm, 2.0 cm, 2.5cm, 3.0 cm
(packaged separately) Reservoir Tubing
• Cylinders, pump and reservoir have InhibiZone Antibiotic Figure 1-8. AMS 700 CXR Penile Prosthesis
Surface Treatment
Note: CXR also available non-connected and without InhibiZone.
-3-
DEVICE DESCRIPTION (CONTINUED)
AMS 700 CXM PROSTHESIS (DISCONTINUED IN THE UNITED STATES)

The AMS 700 CXM prosthesis is designed for a patient with an anatomy
that requires shorter and narrower cylinders. It is also useful for penile
prosthesis revision procedures.
The AMS 700 CXM Prosthesis components are configured as follows:

• Reservoir: 65 ml
• Standard Pump
• Cylinder diameter: 9.5 mm-14.5 mm
• Rear Tip Extenders: Two each—1.0 cm, 2.0 cm
• Cylinders, reservoir and pumps are available with InhibiZone
AMS 700 ULTREX PROSTHESIS

The AMS 700 Ultrex Prosthesis components are configured as follows:
• Tactile or Standard Pump
• Cylinders expand in girth and length
• Cylinders, reservoir and pump are available with InhibiZone
AMS 700 ULTREX PRECONNECT PROSTHESIS

The AMS 700 Ultrex Preconnect components are configured as follows:
• Tactile Pump and cylinders are preconnect
• Infrapubic package has 18 cm tubing connecting pump
and cylinders
• Penoscrotal package has 11 cm tubing connecting pump
and cylinders
• Cylinder lengths: 15 cm, 18 cm
• Cylinders expand in girth and length
• Cylinder and pump combination and reservoir are available with
InhibiZone Antibiotic Surface Treatment
-4-
DEVICE STERILIZATION AND STORAGE

STERILIZATION STORAGE
American Medical Systems sterilizes all of the components The versions of the AMS 700 components with
in the AMS 700 Product Line. InhibiZone Antibiotic Surface Treatment are light
Under normal storage conditions, the components will and temperature sensitive. Care should be taken to
remain sterile until the expiration date if the sterile store the products according to the instructions on
barriers of the packaging remain intact. the package.
Devices with InhibiZone have a different shelf life than CAUTION: Do not store product with InhibiZone
untreated devices. above 40ºC (104ºF).
Always check the expiration date before using products in
the AMS 700 Product Line. CAUTION: Do not use product that is past its
expiration date.
To protect the integrity of the packaging and the function
of the prosthesis, store the sterilized components on a
protected shelf or in a cabinet. The environment should
be clean, dry, and near room temperature. For maximum
protection during storage, leave the component trays
within their dustcover boxes. Inspect the packaging for
damage before use.
CAUTION: Do not resterilize the components of the
AMS 700 Product Line.
CAUTION: Do not resterilize the AMS Suture-Tie
Connectors or the AMS Quick Connect Sutureless
Window Connectors, or other components in the
AMS Accessory Kit.
AMS TOOLS
American Medical Systems has surgical instruments that
can be used during the surgery to help facilitate the
surgeon’s implantation of the penile prosthesis. For
sterilization information, refer to the instructions
provided with the tools. The following non-sterile AMS
tools can be ordered from AMS.
• AMS Tubing Passers
• AMS Closing Tool
• Furlow Insertion Tool
• AMS Quick Connect Assembly Tool
• AMS Sizer
The following tool is provided sterile in the AMS 700
Accessory Kit.
• Proximal Tool
This tool is designed to facilitate the insertion of the
proximal portion of the cylinder into the corpora, and
may also be used to assist in closing.
CAUTION: Do not resterilize or reuse the proximal Figure 2-1. Proximal Tool
tool. It is intended for single use only.
-5-
OPERATING ROOM INSTRUCTIONS

The following instructions are intended as a guide for The AMS Accessory Kit for the AMS 700 Product Line
the surgeon. Various surgical techniques can be used to contains the materials necessary for one implant
implant the AMS penile prosthesis. The instructions procedure. It includes:
here represent one of these techniques.
Special Purpose Needles
CAUTION: This device is to be used only by ✓ Two 15-gauge disposable blunt needles (for filling
physicians who are knowledgeable regarding the use components)
of inflatable penile prostheses. This manual is not ✓ Two 22-gauge disposable blunt needles (for
intended to be a complete reference. flushing air and blood from tubing immediately
before a connection is made)
✓ One pair Keith Needles (for transporting cylinder
For warnings, precautions and contraindications please
pulling sutures through glans)
refer to the Package Insert provided in the product
packaging.
Hemostat Shods
✓ Two 30 cm lengths of tubing (for covering tips of
PREOPERATIVE SETUP hemostats used to prepare components—tubing-
shod hemostats help protect prosthesis from
Instruments tubing damage)
The hospital should provide those instruments normally Tubing Connection Accessories
required for a urological surgical procedure. ✓ Four straight AMS Quick Connect™ Sutureless
Window Connectors
In addition to the AMS 700 Penile Prosthesis ✓ Three right angle AMS Quick Connect™
components, you will need the following sterile setup: Sutureless Window Connectors
✓ One locking ring holder with eight collets
✓ Sterile normal saline (filling and flushing
✓ Three straight suture-tie connectors
solution)
✓ Two right angle suture-tie connectors
✓ Two 60 cc and Two 10 cc syringes (for filling
✓ One tubing plug (to prevent fluid from entering
and flushing prosthesis components)
or leaving the prosthesis during revision surgeries)
✓ Eight mosquito hemostats (for clamping tubing
when prepared with shods)
Documentation
✓ Hegar dilators (7 mm-14 mm), or urethral
✓ One Quick Connect instructions for use brochure
sounds (21Fr-42Fr) (for dilating corpora
✓ One Patient Information Form (PIF)
cavernosa)
✓ One mailing envelope (for returning the
✓ Furlow Insertion Tool (for measuring and
completed PIF to AMS)
passing pulling sutures through glans)
✓ One patient ID card
✓ Reservoir inserter (optional for the penoscrotal
approach only: for placing reservoir)
AMS Proximal Tool
✓ AMS Quick Connect™ Assembly Tool (only
needed for sutureless window connectors)
The AMS Quick Connect™ Assembly Tool must be
✓ AMS Tubing Passers (optional)
ordered separately. It is a reusable stainless steel
✓ AMS Closing Tool (optional) instrument used to assemble the connectors.
✓ AMS Accessory Kit (see description that follows)
✓ AMS CXR Rear Tip Extender Package for CXR The AMS Quick Connect system may be used for new
procedures systems or when all previously implanted components
are removed and replaced with new components.
-6-
OPERATING ROOM INSTRUCTIONS (CONTINUED)
EQUIPMENT PREPARATION OPEN PACKS, INCLUDING DEVICES WITH INHIBIZONE

ANTIBIOTIC SURFACE TREATMENT:
Prepare Hemostats
1. Remove the tray from the dust cover box in the
Use the following procedure to cover the hemostats operating room; the circulating nurse opens the
with the tubing provided in the accessory kit: unlabeled end of the dust cover box.
1. Place tubing on both jaws of hemostats to 2. Remove inner tray from outer tray, using
completely cover serrated surfaces. Completely appropriate sterile technique.
cover all teeth on both jaws of each hemostat.
3. Hold outer tray without touching sterile inner tray.
2. Clamp jaws together until the first click to prevent
excessive pressure on tubing. 4. Have scrub nurse remove sterile inner tray and place
it on a sterile, lint free Mayo stand.
3. Trim the tubing at jaw tip with sharp,
clean scissors. CAUTION: Do not place cloth towels on Mayo
stand. They may transfer lint to the AMS
4. Reserve one pair of scissors as "virgin" tubing components.
scissors throughout procedure. These will be used
for trimming tubing prior to connecting. 5. When ready to prepare AMS components, open
inner tray and place them onto sterile, lint free
Unpack Components Mayo stand.
The AMS 700 Penile Prostheses components are Note: The circulating nurse should record the part and
packaged in sterile trays. serial/lot numbers as well as the size of the components
on the PIF.
Keep the sterile trays in their outside dust cover boxes
until they are in the operating room. Note: The adhesive label at one end of the dust cover
box and the small, removable labels on the side of the
plastic trays contain the part and serial/lot numbers as
well as the size of the components. This information is
also listed on the Tyvek® lid of the outer tray.
-7-
PREPARE COMPONENTS 5. Pump device several times until all air has been
expelled and pump is filled with fluid.
AMS recommends that all components of the AMS 700
Product Line be prepared with sterile normal saline. The 6. Use a tubing-covered hemostat to clamp (one notch
sterile normal saline must remain free of debris that can only) the submerged single black color-coded
block fluid flow through components. tubing about 3 cm from the end. The black color-
coded tubing connects the pump to the reservoir.
Note: The circulating nurse should record the part and
serial/lot numbers as well as the size of the components CAUTION: Do not advance the hemostat’s ratchet
on the PIF. The part and serial/lot numbers as well as more than one notch. Excessive pressure will
the size of the components are listed on the Tyvek pouch. damage the tubing permanently.
7. Use a tubing-covered hemostat to clamp (one notch

Those components that are labeled as being treated with only) the two submerged clear tubes about 3 cm
InhibiZone Antibiotic Surface Treatment should not be from the end. The clear tubing connects pump
submerged in sterile normal saline. to cylinders.
CAUTION: Soaking antibiotic impregnated devices in 8. For a pump treated with InhibiZone Antibiotic
saline will cause the antibiotics to diffuse off the device Surface Treatment, place the pump onto an empty
into the solution. This will cause the solution to turn sterile tray or kidney basin and cover with a sterile
an orange and will reduce the concentration of drape—the pump should not be submerged in saline.
antibiotics on the device. Prior to implanting, the pump should be inspected
for entrapped air.
PREPARE TACTILE OR STANDARD PUMP:
CAUTION: Soaking antibiotic impregnated
1. Partially fill a graduate with sterile, normal saline. devices in saline will cause the antibiotics to diffuse
off the device into the solution. This will cause the
2. Press pump release valve several times to release solution to turn orange and will reduce the
possible air locks. concentration of antibiotics on the device.
3. Submerge pump’s three tubing ends into sterile 9. For a non-InhibiZone treated pump, submerge the
normal saline (Figure 3-1). filled pump into a kidney basin of sterile normal
saline until the surgeon is ready to implant the pump.
4. Hold the pump so that deflate mechanism is
on top.
Figure 3-1. Prepare Pump
-8-
PREPARE PUMP AND CYLINDERS: 9. With the tubing still submerged in the graduate,
■ AMS 700 CX PRECONNECT PENILE PROSTHESIS
clamp (one notch only) the black tubing with a
■ AMS 700 CXR PRECONNECT PENILE PROSTHESIS
tubing covered hemostat.
■ AMS 700 ULTREX PRECONNECT PENILE
PROSTHESIS CAUTION: Do not advance the hemostat’s
ratchet more than one notch. Excessive pressure
The AMS 700 CX Preconnect, CXR Preconnect and will damage the tubing permanently.
Ultrex Preconnect Penile Prosthesis cylinders and
respective pumps are provided already connected. The
10. For components treated with InhibiZone
only connection required of the surgeon is between the
Antibiotic Surface Treatment place the empty
pump and reservoir.
(air removed and no fluid) cylinders and filled
pump onto an empty sterile tray or kidney basin
Once the surgeon has determined the proximal and distal
and cover with a sterile drape—components should
lengths of the corpora cavernosa, choose the appropriate
not be submerged in saline. Prior to implanting,
preconnect cylinder and pump from inventory.
the pump should be inspected for entrapped air.
The following instructions outline the preparation of the
CAUTION: Soaking antibiotic impregnated
device to ensure that the air is removed from the cylinders and
devices in saline will cause the antibiotics to
pump before the surgeon connects the reservoir.
diffuse off the device into the solution. This will
cause the solution to turn orange and will reduce
1. Partially fill a graduate with sterile, normal saline. the concentration of antibiotics on the device.
2. Press pump release valve several times to release
For a non-InhibiZone treated components,
possible air locks. submerge the empty cylinders and filled pump into
a kidney basin of sterile normal saline until the
3. Submerge the single, black color-coded tubing surgeon is ready to implant the cylinders.
from the pump into sterile normal saline.
4. Hold the pump so that deflate mechanism is

on top.
5. Pump the system until the components are

filled; be sure to keep the open tubing end
submerged.
6. Continue holding the pump so that the deflate

mechanism is on top.
7. Press the deflate mechanism and simultaneously

squeeze the cylinders to allow the air to be expelled
from the components; note air bubbles in graduate.
8. Repeat steps 4 through 7 until all the air is

removed from the system—that is, no bubbles are
noted in the graduate during deflation and none
are visible remain in the pump—a few small
"champagne" bubbles are acceptable.
-9-
PREPARE CYLINDERS:
■ AMS 700 CX
■ AMS 700 CXM
Once the surgeon has determined the proximal and distal lengths of the
corpora cavernosa, choose a pair of appropriate length cylinders from
inventory. Prepare the cylinders with sterile normal saline using a 15-gauge
blunt tip needle and a 60 cc syringe by completing the following steps:
1. Attach 15-gauge blunt tip needle to the 60 cc syringe partially filled

with sterile normal saline.
2. Use partially filled syringe to aspirate all air from the cylinder, and
then slowly fill cylinder with sterile normal saline.
– Hold the cylinder from the rear with the front tip down to allow
distal portion of cylinder to fill first (Figure 3-2).
– Inject fluid into cylinder until it is rounded out.
– Aspirate all air from cylinder with syringe. Figure 3-2. Prepare Cylinder
CAUTION: Do not over aspirate to prevent air from being drawn

into cylinder through its semi-permeable silicone elastomer.
3. Repeat this process until all air bubbles have been removed from cylinder.
4. Aspirate all sterile normal saline from cylinder until it is flat.
CAUTION: Do not over aspirate to prevent air from being drawn

into cylinder through its semi-permeable silicone elastomer.
5. Use a tubing-covered hemostat to clamp off (one notch only) tubing 3 cm

from end. then remove the 15-gauge needle and syringe.
CAUTION: Do not advance the hemostat’s ratchet more than one

notch. Excessive pressure will damage the tubing permanently.
6. For a cylinder treated with InhibiZone Antibiotic Surface Treatment,

place the cylinder onto an empty sterile tray or kidney basin and cover
with a sterile drape—cylinders should not be submerged in saline.
CAUTION: Soaking antibiotic impregnated devices in saline will cause
the antibiotics to diffuse off the device into the solution. This will
cause the solution to turn an orange and will reduce the concentration
of antibiotics on the device.
7. For a non-InhibiZone treated cylinder, submerge it in a kidney

basin of sterile normal saline until the surgeon is ready to implant it.
8. Prepare the other cylinder in same manner.
- 10 -
PREPARE RESERVOIRS:
Use two 60 cc syringes with 1 cc gradations when filling the 65 ml or
100 ml reservoir.
1. Attach 15-gauge blunt tip needle and 60 cc syringe partially filled

with sterile normal saline to the reservoir (Figure 3-3).
2. Use partially filled syringe to aspirate all air from reservoir.
3. After air has been removed, inject sterile normal saline.
4. Aspirate all remaining air out of reservoir and into syringe. All air
must be removed to ensure that the pump will function properly.
CAUTION: Do not over aspirate to prevent air from being

drawn into cylinder through its semi-permeable silicone
elastomer.
5. Evacuate fluid from reservoir and leave reservoir flattened.

Use a tubing-covered hemostat to clamp (one notch only) tubing
Figure 3-3. Attach Syringe and Prepare
3 cm from end and then remove the 15-gauge needle and syringe. Reservoir
CAUTION: Do not advance the hemostat’s ratchet more than

one notch. Excessive pressure will damage the tubing
permanently.
6. For a reservoir treated with InhibiZone Antibiotic Surface

Treatment place the reservoir onto an empty sterile tray or kidney
basin and cover with a sterile drape—the reservoir should not be
submerged in saline.
CAUTION: Soaking antibiotic impregnated devices in saline will

cause the antibiotics to diffuse off the device into the solution.
This will cause the solution to turn orange and will reduce
the concentration of antibiotics on the device.
7. For a non-InhibiZone treated reservoir, submerge the reservoir

into a kidney basin of sterile normal saline until the surgeon is
ready to implant it.
- 11 -
SURGICAL PROCEDURES
PREPARE PATIENT
Before the surgery, the surgeon should take adequate steps to limit the risk
of post-operative infection.
CAUTION: Using a device with InhibiZone Antibiotic Surface
Treatment does not change the need to follow normal hospital protocols
for prophylactic antibiotic administration.
Once the patient is in the operating room, the clinician should shave the
abdominal and genital area. Following the shave, the area should be
scrubbed with povidone-iodine soap for ten minutes or the approved
hospital preoperative scrub procedure.
Establish the sterile field, drape, and prepare the patient according to the
physician’s instructions. Throughout the procedure, the surgical site
should be flushed with copious amounts of broad-spectrum antibiotic.
Position the patient according to the physician’s preferred surgical Figure 4-1. Infrapubic: Identify Incision Site
approach: infrapubic or penoscrotal.
SURGICAL APPROACHES
The following descriptions are an overview of the infrapubic and
penoscrotal surgical approaches; the physician will make the final choice
of surgical approach and technique.
Infrapubic Approach
All of the prostheses in the AMS 700 product line can be implanted
through an infrapubic incision. If the prosthesis is preconnect, be
certain that the cylinder/pump package is labeled infrapubic.
Penoscrotal Approach
It is also possible to implant all of the prostheses in the AMS 700
product line through a penoscrotal incision. If the prosthesis is
preconnect, be certain the cylinder/pump package is labeled
penoscrotal. Figure 4-2. Penoscrotal: Identify Incision Site
MAKE INCISION AND DISSECT

1. Place a Foley catheter to facilitate urethra identification. The
Foley catheter will help decompress the bladder and help avoid
bladder injury during reservoir placement.
2. Make the appropriate incision for the surgical approach chosen.
Infrapubic: Make a 4 to 5 cm longitudinal, or transverse
incision, at symphysis pubis (Figure 4-1). Avoid the midline
neurovascular bundle.
Penoscrotal: Make a 2 to 3 cm incision through the median
raphe of the scrotum at the penoscrotal angle (Figure 4-2).
Note: Some physicians place a retractor around the penis and place
the penis on "stretch." It is important to have the IV tubing on the
retractor passed from 3 o’clock to 9 o’clock on the retractor. This
elevates the base of the penis and allows exposure of the corpora.
Figure 4-3. Penoscrotal: Retract Corpus
3. For the penoscrotal approach, laterally retract the corpus
Spongiosum
spongiosum to avoid damaging the urethra (Figure 4-3).
- 12 -
SURGICAL PROCEDURES (CONTINUED)
4. Dissect through Dartos fascia and Bucks fascia to expose the

tunicae albuginea.
5. Place stay sutures.
6. Make an incision into one of the corpora cavernosa

(Figure 4-4).
DILATE AND MEASURE

1. Dilate the proximal corpus cavernosum (crus) and the distal
corpus cavernosum (7-13 mm) to create a space for inserting
a penile cylinder. After dilating one corpus cavernosum, Figure 4-4. Make Corporotomy
incise and dilate the adjacent corpus cavernosum following
the same procedure.
Figure 4-5a. Penoscrotal: Dilate Figure 4-5b. Infrapubic: Dilate
2. Measure each corpus proximally and distally using the

Furlow Insertion Tool or AMS Measuring Tool. Slightly
stretching the penis during this process. These measurements
help the physician select cylinders and rear tip extenders that
fit the patient’s anatomy.
Figure 4-6a. Penoscrotal: Measure Figure 4-6b. Infrapubic: Measure
- 13 -
SELECT APPROPRIATE SIZE CYLINDER

Select the appropriate size cylinders and if applicable, apply rear tip extenders.
Sizing
• AMS 700 CXR
The proximal portion of the AMS 700 CXR cylinder is approximately 2 cm longer than
the CX and Ultrex cylinder. Sizing using Method A is recommended and will result in the
tubing exiting from the corporotomy. The Rear Tip Extenders for the AMS 700 CXR
cannot be stacked. They have an internal interlocking design. Select the appropriate rear
tip length and attach to the cylinder, twisting the RTE onto the cylinder to provide tactile
indication of proper connection.
CAUTION: Do not stack CXR Rear Tip Extenders. the locking mechanism will not
engage and rear tip extenders may not stay connected to each other.
• AMS 700 CX
• AMS 700 Ultrex
There are two methods of selecting cylinder sizes for the AMS 700 CX and Ultrex prostheses.
Each implanting surgeon’s own experience will determine which technique is used.
Method A reduces the length of the solid proximal portion of the cylinders in the
shaft of the penis and allows the tubing sleeve to contact a portion of the
expandable shafts of the cylinders. (Figure 4-7a).
Calculate the Total Corporal Length (distal + proximal)
Example
Distal Corporal Length 12 cm
Proximal Corporal Length +7 cm
Total Corporal Length 19 cm
Select the closest cylinder size that is shorter than or equal to the Total
Corporal Length. Add rear tip extenders, if necessary, to fit the patient’s anatomy. CXR
Example
Selected Cylinder Length -18 cm Figure 4-7a. Method A
Rear Tip Extender Length 1 cm
Method B allows the tubing to exit directly from the corporotomy (Figure 4-7b).
Follow the formula described below to select the appropriate cylinder length and
number of rear tip extenders. If necessary, extend the length of the corporotomy.
Calculate the Total Corporal Length (distal + proximal)
Example
Distal Corporal Length 12 cm
Proximal Corporal Length +7 cm
Subtract 2 cm from the Total Corporal Length to obtain an Adjusted Measurement.
Example
-2 cm
Adjusted Measurement 17 cm
Select the closest cylinder size that is shorter than or equal to the Adjusted Measurement.
Example
Adjusted Measurement 17 cm CX
Selected Cylinder Length 15 cm
Subtract the Selected Cylinder Length from the Total Corporal Length to determine
Figure 4-7b. Method B
the length of rear tip extenders required to fit the patient.
Example
Selected Cylinder Length -15 cm
Rear Tip Extender Length 4 cm
Note: Do not open any component packages until cylinder length is confirmed.
- 14 -
INSERT CYLINDERS
AMS has preplaced a traction suture through the distal tip of each cylinder.
Depending on surgeon preference, either after or before inserting the cylinder
into the crus, complete the following steps:
1. Use the Furlow Insertion Tool (Figure 4-8) and Keith Needle (from AMS
700 Accessory Kit) to help introduce cylinders into the corpora cavernosa.
2. Check function of Furlow Insertion Tool by withdrawing obturator to
locking groove, for the "retracted" position and then fully insert
obturator until tip appears at end.
3. Withdraw obturator to "retracted" or "locked" position. Pass both ends Figure 4-8. Furlow Insertion Tool
of cylinders traction suture (approximately 10 cm) through the eye of a
straight abdominal Keith Needle (Figure 4-9).
Note: Keith Needles are included in the AMS Accessory Kit.
4. Load the blunt end of Keith Needle into the Furlow Insertion Tool
(Figure 4-10) and place suture into insertion tool slot or "barrel".
5. Completely retract suture into slot and fully draw needle into
barrel of tool.
6. Hold the four strands of suture material against the insertion tool and
insert tool into distal portion of corporal body until front tip is
beneath glans.
Note: It is imperative that patient’s penis is aligned symmetrically with his
body and that location of puncture through glans is satisfactorily identified
before pushing needle through glans. The Furlow Insertion Tool should be
in the ipsilateral corpora at the distal tip.
Note: If you cross over through the intro-cavernosal septum to contralateral
side, remove, place dilator into contralateral side and reposition cylinder on Figure 4-9. Insert Traction Suture into
ipsilateral side. No repair is necessary. Keith Needle
7. Place the penis on a mild stretch; push needle through glans by fully
inserting obturator into insertion tool.
8. Grasp needle with a needle holder, and pull it completely through glans.
9. Detach the Keith Needle from traction suture, and remove it from the
area to prevent any accidental puncture of cylinders.
10. Attach a tubing-covered hemostat to the traction sutures to prevent
inadvertent retraction through glans.
11. Insert front tip of cylinder into the corporotomy.
12. Gently push cylinder into place from the corporotomy.
Note: Use the traction suture to guide the cylinder until the front tip is
placed well under the glans.
13. Carefully assess front tip position of cylinder beneath glans.
Note: Take care to leave the traction suture in place through the glans to Figure 4-10. Load Keith Needle
allow the cylinder to be repositioned. If repositioning or more dilation is
required, the cylinder should simply be pulled out of corporal body.
- 15 -
14. Reposition distal tip of cylinder under glans several centimeters

in proximal direction.
15. Fold cylinder back on itself, then push proximal end of cylinder
into the crus while placing traction on the distal penis
(Figure 4-11a, Figure 4-11b). Alternatively, place the “U” shaped
portion of the proximal tool at the junction between the output
tube and cylinder and use the tool to push the proximal end of
the cylinder into the crus while placing traction on the distal
penis. The flatter side of the tool should face toward the cylinder.
16. Once the proximal portion of the cylinder is in place, reposition
the distal portion under the glans by gently pulling on the suture.
17. Assess the cylinder length for satisfactory fit within corpora cavernosa.
Figure 4-11a. Penoscrotal: Insert Cylinders
18. Repeat the procedure to insert the remaining cylinder into the
other corporal body.
COMPLETE INFLATE/DEFLATE TEST
Close corporotomy
1. Close the tunicae albuginea with either a running horizontal
mattress stitch or preplaced sutures, with meticulous attention
to hemostasis.
Note: If using mattress stitch, you may place the winged end of the
AMS Reusable Closing Tool or the foot of the proximal tool over the
cylinder while suture is placed. Move the tool along incisions with
each stitch to protect cylinder.
Perform the first inflate/deflate test
Figure 4-11b. Infrapubic: Insert Cylinders
2. Flush cylinder tubing (Figure 4-12).
3. Attach the 60 cc syringe filled with 55 cc filling solution to
each cylinder.
4. Inflate cylinders to evaluate erection quality.
Note: Check for placement of the cylinder tip, any cylinder buckling,
kinking, or disruption of the suture line, or fluid leakage from the cylinder.
5. Deflate to evaluate flaccidity.
Note: The AMS 700 Ultrex Preconnect and AMS 700 CX Preconnect may
also be inflated and deflated using a syringe in place of the reservoir.
6. If each cylinder is the correct length and position, cut one end of
traction suture approximately 2 cm from the glans; pull it out slowly
to minimize trauma to the glans and the front tip of the cylinder.
Note: Do not remove traction sutures from cylinders until the Figure 4-12. Flush Tubing
completion of surgery in case the cylinders need to be repositioned.
Note: The suture is non-absorbable and must be removed from the glans.
- 16 -
IMPLANT RESERVOIR
Infrapubic Implantation
1. Create a defect in rectus fascia and a pocket in prevesical space

under the rectus muscle to insert the reservoir.
Note: The reservoir tubing may be routed through the rectus fascia
using the AMS Tubing Passer. When using AMS Tubing Passers,
tubing should be placed on knobbed end of passer and passed through
fascia. As an alternative, route tubing directly through midline
between rectus muscles.
Penoscrotal Implantation
1. Create a defect in transversalis fascia through the external inguinal

ring (Figure 4-13a). This defect provides access to the prevesical
space. Once the pocket is created in the prevesical space, use an
inguinal reservoir inserter or similar tool to place the reservoir
into the space (Figure 4-13b). After the reservoir is
implanted, fill it with the appropriate amount of filling solution.
Note: Alternatively, the prepared reservoir may be placed in the

prevesical space through a small inguinal incision. Make a defect in
prevesical space under rectus muscle large enough to accommodate Figure 4-13a. Create Defect
reservoir without putting pressure on it. Then insert the reservoir.
Immediately fill the reservoir with the appropriate amount of filling
solution.
Fill Reservoir
2. After implantation, fill the reservoir with the appropriate amount

of sterile, normal saline.
Note: Be sure to fill reservoir with enough fluid. If reservoir is not

filled with appropriate amount, folds may develop in reservoir. This
increases chance of fluid loss and loss of device function.
Figure 4-13b. Insert Reservoir

(Optional Insertion Tool Shown)
- 17 -
COMPLETE BACK PRESSURE TEST

After the reservoir has been filled with appropriate amount of sterile
normal saline, perform back-pressure test to confirm that fluid is not
under pressure.
1. When thumb is removed from filling syringe plunger, there

should be no flow of filling solution back into syringe barrel.
2. If there is flow into syringe barrel, there may be pressure on

reservoir from surrounding tissue.
3. Determine if reservoir pocket may need to be enlarged or fluid Figure 4-14a. Infrapubic: Bluntly Dissect
needs to be removed from the system.
Note: The pressure on the reservoir from surrounding tissue or over

filling of normal saline may cause spontaneous inflation of the
cylinders.
IMPLANT PUMP
1. Use blunt dissection to form a pocket in the most dependent

portion of the scrotum (Figures 4-14a and 4-14b).
2. Insert the pump into the scrotal pocket.
3. Apply Allis or Babcock clamps to pump tubing through scrotal Figure 4-14b. Penoscrotal: Bluntly Dissect
skin to hold pump in place (Figure 4-15).
Figure 4-15. Insert Pump

(Penoscrotal shown here)
- 18 -
COMPLETE SURROGATE RESERVOIR TEST CONNECT TUBING

Before connecting tubing between the pump and reservoir, 1. Connect the component tubing using AMS Suture-
perform surrogate reservoir test. Tie Connectors or AMS Quick Connect Sutureless
Note: This test is to demonstrate that the pump and Window Connectors, after the cylinders, reservoir,
cylinders work well together. and pump are implanted.
1. Prepare a syringe containing 55 cc of filling solution. CAUTION: AMS Quick Connect Sutureless
Window Connectors should not be used in
2. Attach the 15-gauge blunt needle to the syringe. revision procedures involving previously
implanted component tubing.
3. Flush the pump tubing with 22-gauge blunt needle
Note: Use either straight connectors or right angle
on 10 cc syringe.
connectors, depending on surgeon’s technique and
patient anatomy. A straight connector is the most
4. Connect syringe with 15-gauge needle to tubing while common between reservoir and pump, and two right
holding syringe upright (acting as a reservoir). angle between cylinders and pump. Always use right
angle connectors if the tubing makes a sharp curve at
5. Unclamp the hemostat from the pump tubing. the point of connection.
2. Connect the clear tubing between the cylinders and

6. Squeeze the pump several times to inflate the cylinders
the pump first.
and make the penis erect.
Note: The pump and cylinders are preconnected on
7. Confirm that the cosmetic result is satisfactory. AMS 700 Ultrex Preconnect, AMS 700 CX
Preconnect and AMS 700 CXR Preconnect devices,
Note: The patient’s penis should not buckle or bend and it only the connection between the pump and reservoir is
should be rigid. needed.
Note: Extra tubing between the pump and cylinders
8. Deflate the cylinders by pressing the pump’s deflate may be tucked within surrounding tissues on the
mechanism. AMS 700 Ultrex Preconnect, AMS 700 CXR
Preconnect and AMS 700 CX Preconnect.
Note: The penis should be totally flaccid. All of the fluid
should be stored in the reservoir during postoperative 3. If desired, the protective PTFE (Polytetrafluoroethylene)
healing in order to limit the amount of fibrosis around the sleeve on cylinder tubing may be peeled if it
reservoir. Excessive fibrosis could result in the inability to interfaces with a connection.
completely deflate the cylinders.
4. Gently grasp sleeve at tab and peel sleeve away
9. Reclamp the pump tubing with the tubing covered from tubing.
hemostat.
5. Once sleeve has been peeled to length desired,
excess sleeve may be cut.
10. Remove 15-gauge needle and syringe.
CAUTION: Do not remove so much PTFE
material that bare input tubing touches the
expandable shaft of the cylinder.
6. Space tubing connectors apart from each other to

prevent wear.
- 19 -
AMS QUICK CONNECT SUTURELESS

WINDOW CONNECTORS
1. Clamp tubing using tubing covered hemostats.
2. Trim tubing squarely to fit patient’s anatomy.
3. Slide collet ring onto tubing (Figure 4-17), making sure that
teeth of collet ring face toward tubing end.
Note: The AMS Quick Connect System cannot be resterilized.

Conventional hospital sterilization will damage the connector
Figure 4-17. Slide Collet Ring Onto Tubing
components. However, the AMS Assembly Tool may be resterilized.
4. Repeat with other tubing.
5. Flush end of connector and tubing with sterile normal saline to

remove particulate matter and air using a 22-gauge blunt
tip needle.
6. Insert tubing ends onto connector (Figure 4-18).
7. Firmly push one side of tubing to middle wall of connector and Figure 4-18. Insert Tubing Ends
check tubing placement through connector window.
8. Firmly push other tubing to middle wall. Check connector

window to make certain both tubing ends are still touching
middle walls.
9. Place connector ends in assembly tool jaw (Figure 4-19).
10. Squeeze tool handles until closure stop touches opposite handle.
CAUTION: Check tubing before you close assembly tool. The
tubing must not be trapped between assembly tool jaw and
connector. The tubing must exit straight from ends of the
connector, through the slots in assembly tool. After using AMS
Quick Connect Assembly Tool, tubing should bulge through
Figure 4-19. Place Connector Into
connector window. This indicates that tubing is still firmly Assembly Tool
against the middle wall of the connector.
Note: When using a right angle connector, assembly tool must be used
twice, once on each end of connector. Again, make certain tubing is
touching middle wall on both sides of connector. The closure stop of
assembly tool must touch opposite handle each time a connection
is made.
- 20 -
SUTURE TIE CONNECTORS

1. All connections using AMS Suture-Tie Connectors are tied with
3-0 nonabsorbable polypropylene. Once tubing has been
appropriately trimmed, clamp the component tubing with
tubing covered hemostats.
2. Cut the tubing (Figure 4-20) to fit the patient’s anatomy.
3. Use a 22-gauge blunt tip needle to flush tubing ends

(Figure 4-21) with normal saline to remove particulate matter
and air before connecting.
Figure 4-20. Cut Tubing
4. Use a 22-gauge blunt tip needle to flush connector ends.
5. Push tubing over ends of connector so that they meet at center

hub of connector.
Note: Make sure the tubing is on the connector straight.
6. Use a double-throw overhand surgeon’s knot followed by a

minimum of two single throws to attach tubing to connector
(Figure 4-22).
Note: The suture should crimp, but not cut the tubing. Figure 4-21. Flush Tubing
7. Pass suture 180º and use same tying technique. Then use
another suture and repeat on the opposite end of the connector.
Figure 4-22. Suture Connector
- 21 -
COMPLETE FINAL INFLATE/DEFLATE TEST

1. After all components are connected, inflate the prosthesis to
check the quality of the erection and deflate to evaluate
flaccidity.
Note: The erect penis should present a satisfactory cosmetic result.
Note: The flaccid penis should lie close to body when deflated;
there may be some swelling that precludes a good flaccid result.
Note: If erect or flaccid results are not acceptable, check the amount
of fluid in reservoir and adjust the volume if necessary.
Note: When leaving cylinders slightly inflated, press, but do not

hold, the deflation site to activate the back-pressure valve.
2. Close the incision.
Note: Some physicians close the dartos in two layers with running
2-0 chromic catgut suture then close the skin.
3. Apply a wound dressing and completely deflate the prosthesis.
4. Tape penis to abdomen (Figure 4-23).
5. Optionally, a drain may be placed for 12-24 hours. Figure 4-23. Tape Penis to Abdomen
- 22 -
POSTOPERATIVE PROCEDURES
IMMEDIATELY POSTOPERATIVE Four to six weeks postoperatively, instruct the patient
that it is possible to begin using the prosthesis to have
intercourse. To determine if the patient is ready to use
After the surgery, some physicians partially inflate the
the device:
cylinders for the first 24 hours. This will aid hemostasis.
• Check the incision site to be sure that it has healed
The physician may place a closed system drain in the
properly. There should be no redness, swelling, or
abdomen to drain excess fluid from the incision site.
drainage. Any of these things may indicate that an
infection is present and the infection should be
After 24 hours, remove the dressing and completely
treated promptly with antibiotics.
deflate the cylinders. Support the penis on the abdomen
for four to six weeks to obtain a straight erection.
• Ask the patient about pain when cycling the device and
observe the patient inflating and deflating the device.
AFTER THE PATIENT IS RELEASED
FROM THE HOSPITAL After determining that the patient knows how to operate
the device and that the device is functioning correctly,
The patient is usually discharged in twelve to inform the patient that it is possible to have intercourse.
twenty-four hours.
If the patient is familiar with injection therapies for
After the patient has returned home and the swelling from erectile dysfunction, remind the patient that such
the surgery has subsided, the physician may ask the therapies can cause damage to the penile prosthesis, and
patient to pull down on the pump located in the scrotum thus should not be used.
to properly position it. Positioning the pump makes it
easier for the patient to locate the pump. The pump contains a valve that resists elevated reservoir
pressure. However, there is the possibility that the
The frequency of positioning the pump is up to the device will automatically inflate during the immediate
physician. Some physicians have their patients position postoperative period and the patient may have to return
the pump daily. to the office for deflation. Autoinflation may occur for
a variety of reasons. If this occurs, instruct the patient
To position the pump in the scrotum, a patient should to deflate the prosthesis several times daily. This will
be told to: encourage maximum pseudocapsule formation and
• Locate the pump in the scrotum. reservoir capacity.
• Grasp the pump firmly and carefully pull the pump
down in the scrotum. The patient should gently pull EVALUATING LONG-TERM
the pump into a position close to the outer scrotal FUNCTION AND PLACEMENT
wall.
After the postoperative healing period, the physician
After three to six weeks, the physician may instruct the
should continue to have contact with the patient at least
patient to begin cycling the device for the first time.
on an annual basis to evaluate the function of the
To cycle the device, the patient inflates and deflates the
device. During the annual evaluation, ask the patient
prosthesis several times. It may be painful for the patient
about how the device is functioning and if he has
the first few times that he inflates and deflates the device.
noticed any changes in the function, for example,
However, after the postoperative healing period, the pain
cylinders losing rigidity. Also check the patient for signs
should subside. Instruct the patient to inflate and fully
of infection or erosion.
deflate the prosthesis several times daily. This will
encourage maximum pseudocapsule development and
If the patient is having mechanical difficulty with the
reservoir capacity.
device, or there is infection or erosion present, revision
surgery may be necessary.
- 23 -
COMBINING COMPONENTS OF DIFFERENT MODELS

INTERCHANGING AMS 700 CX Cylinders
If the cylinders of the AMS 700 Ultrex Preconnect, AMS
COMPONENTS WITH AMS 700 ULTREX 700 CXR Preconnect or AMS 700 CX Preconnect
COMPONENTS become damaged during the primary surgery the entire
pump and cylinders component should be replaced.
It is possible to combine components from different
prostheses in the AMS 700 Product Line if necessary to
meet patient requirements during both primary and
secondary surgeries. (See product line matrix for reservoir
recommendations).
Reservoirs
Although the 100 ml reservoir is suitable for all AMS 700
Ultrex sizes, you may choose to use the 65 ml reservoir
with the 12 cm and 15 cm AMS 700 Ultrex sizes if an
inflate/deflate test indicates that 55 cc or less of fluid is
necessary to inflate both cylinders. However, the 100 ml
reservoir should always be used with the 18 cm and 21
cm AMS 700 Ultrex sizes.
Follow the applicable instructions for preparing the

reservoir from the Component Preparation section of this
manual (pages 11, 12). Implant and fill the reservoir.
Pump
If the pump for the AMS 700 Ultrex Preconnect, AMS
700 CXR Preconnect or AMS 700 CX Preconnect is
damaged during surgery, and if the cylinders have already
been implanted, a separate AMS pump may be
substituted. This method can also be used if a Tactile
Pump is desired for a device that is preconnected to a
standard 700 pump.
1. Clamp (one click only) each of the clear tubing

between the pump and the cylinders with a tubing
covered hemostat.
2. Use clean, sharp scissors to cut the pump tubing

and remove the pump.
3. Implant the pump and reconnect the new pump to

the cylinders using either AMS Suture-Tie
Connectors or AMS Quick Connect Sutureless
Window Connectors.
- 24 -
TROUBLESHOOTING
CYLINDERS
Problem What to Do
Sized incorrectly • Redilate and remeasure. Remove cylinder and add rear tip extenders to adjust
length. If unable to adjust length with rear tip extenders, remove cylinder and
replace with cylinder of the appropriate size.
Punctured • Remove damaged cylinder and replace.
Won’t inflate • Determine that the input tube is not kinked. If it is kinked, gently straighten it.
• Be sure that the cylinder has not buckled. If the cylinder has buckled, be sure that it
has been inserted properly.
• If the cylinder still won’t inflate, remove them and replace.
Won’t deflate • Be sure the pump is being released correctly.

• Determine that the input tube is not kinked. If it is kinked, gently straighten it.
• Be sure that the tubing between the pump and the cylinders is clear of debris. If
there is debris in the tubing, clamp the tubing with tubing covered hemostats,
remove the connector, flush the system, and reconnect the system.
• Perform the Back Pressure Test to determine if there is pressure on the reservoir.
If necessary, create a larger space for the reservoir.
• Be sure that the cylinders are properly sized and are positioned without kinks.
RESERVOIRS
Problem What to Do
Can’t fill • Be sure the reservoir "nipple" is not rolled over onto the reservoir. The reservoir
“nipple” should follow the tubing exit path through the fascia layer. Do not allow
excess tubing to lie on the reservoir.
PUMP
Problem What to Do
Won’t inflate • Remove the pump from the scrotum and try to inflate it outside of the body
in a basin of sterile normal saline.
- 25 -
PRODUCT LINE MATRIX
AMS 700 PENILE PROSTHESIS PRODUCT LINE MATRIX
Cylinder Reservoir Included RTE Selection Available Available

Size Recommendations preconnect* with
InhibiZone
0.5 cm
100 cc
Tactile Standard
65 cc
1 cm
2 cm
3 cm
Pump Pump
AMS 12 cm ✔ 1 pair 2 pair ✔

700 CXM 14 cm ✔ 1 pair 2 pair ✔
Inflates in girth 16 cm ✔ 1 pair 2 pair ✔
18 cm ✔ 1 pair 2 pair ✔
AMS 12 cm ✔ 1 pair 1 pair 1 pair 1 pair ✔

700 CX 15 cm ✔ 1 pair 1 pair 1 pair 1 pair ✔ ✔
Inflates in girth
18 cm ✔ 1 pair 1 pair 1 pair 1 pair ✔ ✔
21 cm ✔ ✔ 1 pair 1 pair 1 pair 1 pair ✔
AMS 12 cm ✔ 1 pair 1 pair 1 pair 1 pair ✔

Ultrex 15 cm ✔ 1 pair 1 pair 1 pair 1 pair ✔ ✔
Inflates in
length and girth
18 cm ✔ 1 pair 1 pair 1 pair 1 pair ✔ ✔
21 cm ✔ 1 pair 1 pair 1 pair 1 pair ✔
AMS 700 CXR ✔

12 cm Rear Tip Extender package ✔ ✔
Inflates in girth
14 cm ✔ contains 2 each of ✔ ✔
16 cm ✔ 0.5 cm, 1.0 cm, 1.5 cm, ✔ ✔
18 cm ✔ 2.0 cm, 2.5 cm, 3.0 cm ✔ ✔
* Stand-alone Tactile Pump available for connection to any cylinders.
- 26 -
APPENDIX
INHIBIZONE ANTIBIOTIC PARYLENE COATING
SURFACE TREATMENT Parylene coating is a medical grade polymer designed to
reduce friction-based wear occurrences on a variety of
AMS has a proprietary process to impregnate antibiotics
surface and texture materials. On the AMS 700
into the tissue-contacting surfaces of the penile prosthesis.
Product Line Penile Prostheses cylinders, an innovative
This InhibiZone Antibiotic Surface Treatment innovation is
micro-thin Parylene coating is applied to both sides of
intended to elute the antibiotics from the device surface
the internal cylinders surfaces and to the internal surface
when exposed to a warm, moist environment. In in vitro
of the outer cylinder.
testing using susceptible organisms, this elution provided
antibiotic action both on the surface and in a zone
The coating is 60 millionths of an inch thin. This has
surrounding the treated device.
added millions of twist cycles in laboratory bench
Existing prophylactic antibiotic protocols should be maintained testing before wear is detected.
as determined by the physician and or institution.
The AMS patented antibiotic surface treatment process uses
a formulation of minocycline hydrochloride and rifampin
(rifampicin). Based on in vitro extraction studies, the
appropriate amounts of the antibiotics on a complete,
InhibiZone treated device range from 3 mg minocycline and
9 mg rifampin (rifampicin) for the smallest configuration (50
ml reservoir, pump, and 2 ea 12 cm CXM cylinders) to 10
mg minocycline and 25 mg rifampin (rifampicin) for the
largest configuration (100 ml reservoir, pump, and 2 ea 24
cm CX cylinders).
In vitro studies with the antibiotic treated device material and

susceptible strains of Staphylococcus epidermidis and
Staphylococcus aureus show a microbial “zone of inhibition”
around the test material. The clinical significance of these
in-vitro data is unknown. A limited animal model study
suggests that this surface treatment may reduce the potential
for bacterial colorization of the treated device.
No clinical studies have been performed to evaluate the effect
of the antibiotic surface treatment reducing the incidence of
penile implantation infections.
• InhibiZone is contraindicated for patients:

- Sensitive to rifampin (rifampicin) or tetracyclines
- With lupus erthematosus
• InhibiZone should be carefully considered for patients:
- With renal disease
- Taking warfarin, thonamides, isoniazid and halothane
Note: For complete list of indications, contraindictions,
warnings and precautions, refer to the Instructions for Use
for the AMS Penile Prostheses with InhibiZone and for the
drugs rifampin (rifampicin) and minocycline.
- 27 -
Solutions for Life™ American Medical Systems is a world

leader in medical devices and procedures that treat: incontinence,
prolapse, excessive menstrual bleeding, erectile dysfunction (ED) and
benign prostate hyperplasia (BPH). Any one of these conditions can
profoundly diminish a patient’s quality of life and significantly impact
relationships. Our products provide a cure or reduce the incapacitating
effects of these diseases, often through minimally invasive surgery.
American Medical Systems, Inc. American Medical Systems American Medical Systems American Medical Systems
World Headquarters Europe B.V. Australia Pty. Ltd. Canada Inc.
10700 Bren Road West Straatweg 66H Suite 2, Level 2 P.O. Box 461
Minnetonka, MN 55343 3621 BR Breukelen 460 Church Street Guelph, Ontario
USA THE NETHERLANDS North Parramatta 2150 N1H6K9 CANADA
NSW AUSTRALIA
Phone: 952 930 6000 Phone: 31 346 258 100 Phone: 61 2 8838 8800 Phone: 519 826 5333
Fax: 952 930 6157 Fax: 31 346 258 130 Fax: 61 2 9890 9899 Fax: 519 821 1356
www.AmericanMedicalSystems.com
A Publicly Traded Company
(Nasdaq: AMMD)
©2004 American Medical Systems, Inc. All rights reserved. Printed in USA.
Order Number: 22000032D (07/04)

Procedimento Implante AMS 700 CX

Uploaded by

Document Information

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

Procedimento Implante AMS 700 CX

Uploaded by

Copyright:

Available Formats

InProcess700GlobalOrm.

qkd 7/22/04 12:53 PM Page 1

✔ AMS 700 CX™ Penile Prosthesis

The AMS 700 Penile Prostheses are totally implantable, closed

Figure 1-3. System Deflation

TACTILE PUMP Figure 1-4a. CXR Penile Prosthesis: Cylinders

The pump (Figure 1-5) consists of:

RESERVOIR Figure 1-5. Penile Prosthesis: Tactile Pump

The reservoir (Figure 1-6) consists of:

The single, color-coded tubing connects the reservoir to the pump.

Figure 1-6. Penile Prosthesis: Reservoir

DEVICE DESCRIPTION (CONTINUED)

AMS 700 CX PROSTHESIS

AMS 700 CXR PRECONNECT PROSTHESIS

The AMS 700 CXR Prosthesis components are configured as follows:

DEVICE DESCRIPTION (CONTINUED)

AMS 700 CXM PROSTHESIS (DISCONTINUED IN THE UNITED STATES)

The AMS 700 CXM Prosthesis components are configured as follows:

AMS 700 ULTREX PROSTHESIS

AMS 700 ULTREX PRECONNECT PROSTHESIS

DEVICE STERILIZATION AND STORAGE

OPERATING ROOM INSTRUCTIONS

OPERATING ROOM INSTRUCTIONS (CONTINUED)

EQUIPMENT PREPARATION OPEN PACKS, INCLUDING DEVICES WITH INHIBIZONE

OPERATING ROOM INSTRUCTIONS (CONTINUED)

7. Use a tubing-covered hemostat to clamp (one notch

Figure 3-1. Prepare Pump

OPERATING ROOM INSTRUCTIONS (CONTINUED)

4. Hold the pump so that deflate mechanism is

5. Pump the system until the components are

6. Continue holding the pump so that the deflate

7. Press the deflate mechanism and simultaneously

8. Repeat steps 4 through 7 until all the air is

OPERATING ROOM INSTRUCTIONS (CONTINUED)

1. Attach 15-gauge blunt tip needle to the 60 cc syringe partially filled

CAUTION: Do not over aspirate to prevent air from being drawn

4. Aspirate all sterile normal saline from cylinder until it is flat.

CAUTION: Do not over aspirate to prevent air from being drawn

5. Use a tubing-covered hemostat to clamp off (one notch only) tubing 3 cm

CAUTION: Do not advance the hemostat’s ratchet more than one

6. For a cylinder treated with InhibiZone Antibiotic Surface Treatment,

7. For a non-InhibiZone treated cylinder, submerge it in a kidney

8. Prepare the other cylinder in same manner.

OPERATING ROOM INSTRUCTIONS (CONTINUED)

1. Attach 15-gauge blunt tip needle and 60 cc syringe partially filled

2. Use partially filled syringe to aspirate all air from reservoir.

3. After air has been removed, inject sterile normal saline.

CAUTION: Do not over aspirate to prevent air from being

5. Evacuate fluid from reservoir and leave reservoir flattened.

CAUTION: Do not advance the hemostat’s ratchet more than

6. For a reservoir treated with InhibiZone Antibiotic Surface

CAUTION: Soaking antibiotic impregnated devices in saline will

7. For a non-InhibiZone treated reservoir, submerge the reservoir

MAKE INCISION AND DISSECT

SURGICAL PROCEDURES (CONTINUED)

4. Dissect through Dartos fascia and Bucks fascia to expose the

5. Place stay sutures.

6. Make an incision into one of the corpora cavernosa

DILATE AND MEASURE

Figure 4-5a. Penoscrotal: Dilate Figure 4-5b. Infrapubic: Dilate

2. Measure each corpus proximally and distally using the

Figure 4-6a. Penoscrotal: Measure Figure 4-6b. Infrapubic: Measure

SURGICAL PROCEDURES (CONTINUED)

SELECT APPROPRIATE SIZE CYLINDER