AMS 700 LGX User manual

AMS 700™with MS Pump™
Penile Prosthesis
Operating
Room Manual
English

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IntroductIon ....................5
Overview............................5
devIce descrIptIon ...............6
Cylinders............................6
Pump ..............................6
Reservoir ............................6
AMS 700 CX with MS Pump Prosthesis ...7
AMS 700 LGX with MS Pump Prosthesis..7
AMS 700 CXR with MS Pump Prosthesis ..8
devIce sterIlIzatIon and storage. . . 9
Sterilization..........................9
AMS Tools . . . . . . . . . . . . . . . . . . . . . . . . . .9
Storage .............................9
operatIng room InstructIons . . . . 10
Preoperative Setup ...................10
Equipment Preparation................11
surgIcal procedures.............12
Prepare Patient ......................12
Surgical Approaches ..................12
Make Incision and Dissect .............13
Dilate and Measure...................14
Select Appropriate Size Cylinder.........15
Unpack Components .................16
Open Packs, Including Devices with
Inhibizone Antibiotic Surface Treatment ..16
Prepare Components..................16
Prepare Non-connected
AMS 700 MS Pump ..................16
Prepare Preconnected
MS Pump and Cylinders...............17
Prepare Non-Connected Cylinders .......18
Prepare Reservoirs ....................18
Insert Cylinders......................20
Implant Reservoir ....................21
Implant Pump.......................22
Complete Inflate/Deflate Test...........23
Complete Surrogate Reservoir Test.......24
Connect Cylinders And Reservoir........24
Connecting Tubing...................24
AMS Quick Connect Sutureless
Window Connectors..................25
Suture Tie Connectors ................26
Complete Final Inflate/Deflate Test ......27
postoperatIve procedures . . . . . . . . 28
Immediately Postoperative .............28
After the Patient is Released
from the Hospital ....................28
Evaluating Long-term Function
and Placement.......................28
combInIng components of
dIfferent models ...............29
Combining AMS 700 Components......29
troubleshootIng................30
Cylinders...........................30
Reservoirs ..........................30
Pump .............................30
product lIne matrIx ............31
appendIx .......................32
InhibiZone Antibiotic
Surface Treatment....................32
Parylene Coating.....................32
Brief Summary ......................32
T  C

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Figure 1-1. AMS Penile Prosthesis
Figure 1-3. System Deflation
overvIew
The American Medical Systems (AMS) 700 Penile Prosthesis Product
Line includes the following implantable prosthetic devices:
9AMS 700™ CX with MS Pump™
Penile Prosthesis
9AMS 700™ CX Preconnect with MS Pump™
Penile Prosthesis
9AMS 700™ CXR with MS Pump™
Penile Prosthesis
9AMS 700™ CXR Preconnect with MS Pump™
Penile Prosthesis
9AMS 700 LGX™ with MS Pump™
Penile Prosthesis
9AMS 700 LGX™ Preconnect with MS Pump™
Penile Prosthesis
All configurations are available with InhibiZone™ Antibiotic
Treatment, which is an antibiotic surface treatment of rifampin
(rifampicin) and minocycline hydrochloride (HCl).
The AMS 700 Penile Prostheses with MS Pump are totally
implantable, closed fluid-filled system (Figure 1-1) consisting of:
• Two cylinders
• One pump
• One fluid reservoir
The reservoir stores the fluid that fills and expands the penile
cylinders. The patient operates the pump to inflate or deflate the
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 the deflation
button for 2-4 seconds. This transfers fluid back into the reservoir
making the penis flaccid (Figure 1-3). The penis can be made more
flaccid by squeezing on the penis shaft. All components are connected
by kink-resistant tubing (KRT).
For warnings, precautions and contraindications please refer to
the Instructions for Use provided on the AMS website at www.
amselabeling.com.
I
Figure 1-2. System Inflation
Reservoir
Cylinder
Pump Bulb
Deflation
Button

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Pump
Bulb
Color-
Coded
Tube
KRT
Deflation
Button
Figure 1-5. Penile Prosthesis: Pump
Figure 1-6. Penile Prosthesis: Reservoir
cylInders
Each cylinder kit (Figure 1-4, Figure 1-4a) consists of:
• 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
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
The cylinders come in various lengths and diameters, depending on
the model number. Rear Tip Extenders are provided in a separate kit.
Rear Tip Extenders are placed over the solid rear tip of the cylinder in
a combination appropriate for the patient’s anatomical length.
pump
The pump (Figure 1-5) consists of:
• Pump bulb
• Deflation button
• Three silicone, kink resistant tubes (KRT)
• Internal lock-out valve
The MS pump is used with all types of AMS 700 Series cylinders.
The single, black-striped tubing connects the pump to the reservoir.
The pair of clear tubing connects the pump to the two penile
cylinders. In the preconnect systems, the connections between the
pump and cylinder are made at the factory.
reservoIr
The reservoir (Figure 1-6) consists of:
• One silicone fluid storage reservoir, coated on the inside with
Parylene (provides wear protection)
• One silicone, black-striped kink resistant tube (KRT)
• Two size options:
- 65 ml (spherical reservoir only)
- 100 ml (spherical reservoir and AMS Conceal™
Low Profile Reservoir)*
The single, black-striped tubing connects the reservoir to the pump.
*not available in all markets
Figure 1-4a. CXR Penile Prosthesis: Cylinders
D D
KRT
Reservoir
Spherical
Reservoir
AMS Conceal Low
Profile Reservoir
Figure 1-4.
CX, CXR, LGX Penile Prosthesis: Cylinders
Traction
Suture
KRT
PTFE
Cylinder

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D D ()
ams 700 cx wIth ms pump prosthesIs
The AMS 700 CX Preconnect with MS Pump Prosthesis components
are configured as follows:
• Pump and cylinders are available pre-connected or unconnected
• Unconnected cylinder configuration has 30 cm of tubing
• Infrapublic pre-connect configuration has 18 cm of tubing
connecting pump and cylinders
• Preconnected-Penoscrotal configuration has tubing connecting
pump and cylinders. Tubing connection lengths are listed below:
Cylinder Length Tubing Length
12 cm 9 cm
15 cm 9 cm
18 cm 10 cm
21 cm 12 cm
24 cm 14 cm
• Reservoir: 65 ml (spherical reservoir only),
100 ml (spherical reservoir and AMS Conceal Low Profile Reservoir)
• Cylinder diameter: 12 mm-18 mm
• Cylinder lengths: 12 cm, 15 cm, 18 cm, 21 cm, 24 cm
• Rear Tip Extenders: RTE kit contains two each-0.5 cm, 1.0 cm,
1.5 cm stackable, 2.0 cm, 3.0 cm, 4.0 cm, 5.0 cm, 6.0 cm
(packed in their own tray).
• Cylinders expand only in girth
• Cylinders, pump and reservoir are available with InhibiZone
Antibiotic Surface Treatment
ams 700 lgx wIth ms pump prosthesIs
The AMS 700 LGX Preconnect with MS Pump components are
configured as follows:
• Pump and cylinders are available pre-connected and unconnected
• Unconnected cylinder configuration has 30 cm of tubing
• Infrapublic pre-connected package has 18 cm tubing connecting
pump and cylinders
• Preconnected-Penoscrotal configuration has tubing connecting
pump and cylinders. Tubing connection lengths are listed below:
Cylinder Length Tubing Length
12 cm 9 cm
15 cm 9 cm
18 cm 10 cm
21 cm 12 cm
Cylinders
Pump
KRT
Figure 1-7. AMS 700 CX, LGX
Penile Prosthesis
Low Profile or
Spherical Reservoir

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• Reservoir: 65ml (spherical reservoir only), 100 ml (spherical reservoir
and AMS Conceal Low Profile Reservoir)
• Cylinder diameter: 12 mm-18 mm
• Cylinder lengths: 12 cm, 15 cm, 18 cm, 21 cm
• Rear Tip Extenders:
• RTE kit contains two each-0.5 cm, 1.0 cm, 1.5 cm stackable, 2.0
cm, 3.0 cm, 4.0 cm, 5.0 cm, 6.0 cm (packed in their own tray).
• Cylinders expand in girth and length
• Cylinder, pump and reservoir are available with InhibiZone
Antibiotic Surface Treatment
ams 700 cxr wIth ms pump prosthesIs
The AMS 700 CXR prosthesis is designed for a patient with an
anatomy that requires shorter and narrower cylinders. It is also useful
for penile prosthesis re-implantation procedures.
The AMS 700 CXR Prosthesis with MS Pump components are
configured as follows:
• Pump and cylinders are available pre-connected or unconnected
• Unconnected cylinder configuration has 18 cm of tubing
• Infrapubic pre-connected package has 15 cm tubing connecting
pump and cylinders
• Penoscrotal package has 9 cm tubing connecting pump and
cylinders
• Reservoir: 65 ml (spherical reservoir only), 100 ml (spherical reservoir
and AMS Conceal Low Profile Reservoir)
• Cylinder diameter: 9.5 mm-14.5 mm
• Cylinder lengths: 10* cm, 12 cm, 14 cm, 16 cm, 18 cm
• Rear Tip Extenders: RTE kit contains two each—0.5 cm,
1.0 cm, 1.5 cm stackable, 2.0 cm, 3.0 cm, 4.0 cm, 5.0 cm,
6.0 cm (packed in their own tray).
• Cylinders expand only in girth
• Cylinder, pump and reservoir are available with InhibiZone
Antibiotic Surface Treatment
*Special Order Only. Allow 6-8 weeks for delivery.
D D()
Figure 1-8. AMS 700 CXR Penile Prosthesis
Low Profile or
Spherical Reservoir
KRT
Cylinders
Pump

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sterIlIzatIon
American Medical Systems sterilizes all of the components
in the AMS 700 with MS Pump Product Line.
Under normal storage conditions, the components will
remain sterile until the expiration date if the sterile
barriers of the packaging remain intact.
Devices with InhibiZone have a different shelf life than
untreated devices.
Always check the expiration date before using products in
the AMS 700 with MS Pump Product Line.
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 pouches within their
plastic travel cases. Inspect the packaging for damage
before use.
CAUTION: Do not resterilize the components of the
AMS 700 with MS Pump Product Line.
CAUTION: Do not resterilize any component 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 reprocessing information, refer to the instructions
manual 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.
D S  S
CAUTION: Do not resterilize or reuse the proximal
tool. It is intended for single use only.
The following tools are provided sterile in separate packages
• AMS Cavernotome
• SKW Retractor Kit
CAUTION: Do not resterilize or reuse the AMS
Cavernotome or SKW Retractor Kit. They are
intended for single use only.
storage
The versions of the AMS 700 with MS Pump
components with InhibiZone Antibiotic Surface
Treatment are light and temperature sensitive. Care
should be taken to store the products according to the
instructions on the package.
CAUTION: Do not store product with InhibiZone
above 40ºC (104ºF).
CAUTION: Do not use product that is past its
expiration date.
Figure 2-1. Proximal Tool

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The following instructions are intended as a guide for
the surgeon. Various surgical techniques can be used
to implant the AMS penile prosthesis. The instructions
here represent one of these techniques.
CAUTION: This device is to be used only by
physicians who are knowledgeable regarding the use
of inflatable penile prostheses. This manual is not
intended to be a complete reference.
preoperatIve setup
Instruments
The hospital should provide those instruments normally
required for a urological surgical procedure.
In addition to the AMS 700 Penile Prosthesis
components, you will need the following sterile setup:
9Sterile normal saline (filling and flushing solution)
9Two 60 cc and Two 10 cc syringes (for filling
and flushing prosthesis components)
9Eight mosquito hemostats (for clamping tubing
when prepared with shods)
9One pair of clean, sharp scissors for trimming
tubing
9Hegar dilators (7 mm-14 mm), or urethral sounds
(21Fr-42Fr) (for dilating corpora cavernosa)
9Furlow Insertion Tool (for measuring and
passing pulling sutures through glans)
9AMS Quick Connect Assembly Tool (only
needed for sutureless window connectors)
9AMS 700 with MS Pump Accessory Kit (see
description that follows)
9AMS 700 with MS Pump Rear Tip Extender Kit
9Cavernotomes (optional)
9AMS Tubing Passers (optional)
9AMS Closing Tool (optional)
9SKW Retractor System (optional)
The AMS 700 with MS Pump Accessory Kit for the AMS
700 with MS Pump Product Line contains the materials
necessary for one implant procedure. It includes:
Special Purpose Needles
9Two 15-gauge disposable blunt needles (for filling
components)
9Two 22-gauge disposable blunt needles (for
flushing air and blood from tubing immediately
before a connection is made)
9One pair Keith Needles (for transporting cylinder
pulling sutures through glans)
Note: The Keith needles are “lightening bolt” shaped -the
bend is normal.
Hemostat Shods
9Four 13 cm lengths of tubing (for covering tips of
hemostats used to prepare components—tubing-
shod hemostats help protect prosthesis from tubing
damage)
Tubing Connection Accessories
9Four straight AMS Quick Connect Sutureless
Window Connectors
9Three right angle AMS Quick Connect
Sutureless Window Connectors
9One locking ring holder with eight collets
9Three straight suture-tie connectors
9Two right angle suture-tie connectors
9One tubing plug (to prevent fluid from entering
or leaving the prosthesis during revision surgeries)
Documentation
9One Quick Connect instructions for use brochure
9One Patient Information Form (PIF)
9One mailing envelope (for returning the
completed PIF to AMS)
9One patient ID card
AMS Proximal Tool
The AMS Quick Connect Assembly Tool must
be ordered separately. It is a reusable stainless steel
instrument used to assemble the connectors.
The AMS Quick Connect system may be used for new
systems or when all previously implanted components
are removed and replaced with new components.
O R I

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equIpment preparatIon
Unpacking the AMS Accessory Kit
1. Remove the tray from the dust cover box in the
operating room
2. Have the scrub nurse remove the inner tray from
outer tray, using appropriate sterile technique, and
place inner tray on a sterile, lint free Mayo stand.
3. Open the inner tray and place it on the sterile, lint
free Mayo stand.
Note: The circulating nurse should record the part
and serial lot/numbers of the Accessory Kit on the
PIF. 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.
This information is also listed on the Tyvek™ lid of
the outer tray.
Prepare Hemostats
Use the following procedure to cover the hemostats
with the blue tubing provided in the accessory kit:
1. Place blue tubing on both jaws of hemostats to
completely cover serrated surfaces.
2. Clamp jaws together until the first click to prevent
excessive pressure on tubing.
3. Trim the tubing at jaw tip with sharp, clean scissors.
4. Reserve one pair of scissors as “clean” tubing
scissors throughout procedure. These will be used
throughout the surgery for trimming tubing prior to
connecting. These should be straight scissors.
O R I ()

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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 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 with MS Pump product line
can be implanted through an infrapubic incision. If the prosthesis is
preconnected, 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
with MS Pump product line through a penoscrotal incision. If the
prosthesis is preconnected, be certain the cylinder/pump package is
labeled penoscrotal.
S P
Figure 4-1. Infrapubic: Identify Incision Site

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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.
Penoscrotal: Make a 2 to 3 cm incision through the median
raphe of the scrotum at the penoscrotal angle.
• When using the SKW retractor, place the ring retractor on
the patient with the large ring toward the patient’s head
(cephalad) and the smaller ring towards the patient’s feet
(caudal). (Figure 4-2).
• After orienting the retractor, place the sharp blue hook
in the meatus, then draw the penile strap tight, like a
bowstring. Attach the penile strap at the 3 o’clock and 9
o’clock positions on the ring retractor.
• Make a high scrotal incision, move the incision onto the
penis and do not let go.
• While holding the incision on the penis, place hooks at 1, 5,
7, 11, 3 & 9 o’clock (Figure 4-2).
Infrapubic: Make a 4 to 5 cm longitudinal, or transverse
incision, at symphysis pubis (Figure 4-1). Avoid the midline
neurovascular bundle.
3. For the penoscrotal approach, laterally retract the corpus
spongiosum to avoid damaging the urethra (Figure 4-3).
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).
S P ()
Figure 4-4. Make Corporotomy
Figure 4-3. Penoscrotal: Retract Corpus
Spongiosum
Figure 4-2. Penoscrotal: Identify Incision Site

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S P ()
dIlate and measure
1. Using a series of dilation tools, dilate the proximal corpus cavernosum (towards the crus) at least to 11 mm if the
cylinder tubing will exit directly from the corporotomy, larger if the tubing will be inside the proximal corpus
cavernosum and the distal corpus cavernosum to at least 12 mm to create a space for inserting a penile cylinder. After
dilating one corpus cavernosum, incise and dilate the adjacent corpus cavernosum following the same procedure.
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.
Note: Measuring both directions from one of the stay sutures provides consistency. However, when using LGX devices, some
physicians choose to measure distally from the distal edge of a 2 cm corporotomy and proximally from the proximal end of
a 2 cm corporotomy for a more optimal sizing of the device.
Figure 4-5a. Penoscrotal: Dilate Figure 4-5b. Infrapubic: Dilate
Figure 4-6a. Penoscrotal: Measure Figure 4-6b. Infrapubic: Measure

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S P ()
select approprIate sIze cylInder
Select the appropriate size cylinders and if applicable, apply rear tip extenders.
Sizing
• AMS 700 CXR with MS Pump
• The proximal portion of the CXR cylinder is approximately 1.5 cm longer than the CX and LGX cylinder. Sizing using Method A is
recommended and will result in tubing exiting from the corporotomy. Except for the 1.5 cm rear tip extender, the RTEs 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 other than the 1.5 cm RTE. If other sizes of RTE are stacked, then the locking
mechanism will not engage and rear tip extenders may not stay connected to each other.
• AMS 700 CX with MS Pump and LGX with MS Pump
• CAUTION: Do not stack CX/LGX Rear Tip Extenders other than the 1.5cm RTE. If other sizes of RTE are stacked, then the locking
mechanism will not engage and rear tip extenders may not stay connected to each other.
• There are two methods of selecting cylinder sizes for the AMS 700 CX and LGX prostheses . Each surgeon’s own implanting 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). As the tubing is partially buried in the corpora, using
Method A has the potential to increase the likelihood of tubing compression or kinking, which may reduce fluid flow. If you believe
the tubing is kinked, attempt to gently straighten it.
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.
Example
Total Corporal Length 19 cm
Selected Cylinder Length -18 cm
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
Total Corporal Length 19 cm
Subtract 2 cm from the Total Corporal Length to obtain an Adjusted Measurement.
Example
Total Corporal Length 19 cm
-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
Selected Cylinder Length 15 cm
Subtract the Selected Cylinder Length from the Total Corporal Length to determine
the length of rear tip extenders required to fit the patient.
Example
Total Corporal Length 19 cm
Selected Cylinder Length -15 cm
Rear Tip Extender Length 4 cm
Note: Do not open any component packages until cylinder length is confirmed.
Figure 4-7a. Method A
CXR
Figure 4-7b. Method B
CX

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unpack components
The AMS 700 with MS Pump Penile Prosthesis components are packaged in sterile pouches, except the RTE’s, which
are packaged in sterile trays.
Keep the sterile products in their plastic travel cases until they are in the operating room.
open packs, IncludIng devIces wIth
InhIbIzone antIbIotIc surface treatment
1. Remove the product from the outer travel box in the operating room.
2. Have scrub nurse remove sterile inner pouch and place it on a sterile, lint free Mayo stand.
CAUTION: Do not place cloth towels on Mayo stand. They may transfer lint to the AMS components.
3. When ready to prepare AMS components, open inner pouch and place them onto sterile, lint free Mayo stand.
Note: The circulating nurse should record the part and serial/lot numbers as well as the size of the components of the PIF.
Note: The small, removable adhesive labels contain the part and serial/lot numbers as well as the size of the components.
prepare components
AMS recommends that all components of the AMS 700 with MS Pump Product Line be prepared with sterile normal
saline. The sterile normal saline must remain free of debris that can block fluid flow through components.
Note: The circulating nurse should record the part and serial/lot numbers as well as the size of the components on the PIF. The
part and serial/lot numbers as well as the size of the components are listed on the product pouch.
Those components that are labeled as being treated with InhibiZone Antibiotic Surface Treatment
should not be submerged in sterile normal 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.
prepare non-connected ams 700 ms pump
1. Partially fill a graduate with sterile, normal saline.
2. Submerge pump’s three tubing ends into sterile normal saline. (Figure 4-8)
3. Hold the pump so the deflate mechanism is on top.
4. Squeeze the deflation button 1 time and release.
5. Make an initial hard, quick squeeze of the pump bulb. Saline should appear in the
pump bulb.
Note: This step is important to lubricate the valves of the pump for further prepping.
Note: If saline does not appear in the pump bulb or if the bulb does not fully reinflate, press the deflation button 1 time and release.
This will reset the pump. Repeat Step 5. This sequence may be required more than once to get the pump activated.
6. Following the initial squeeze, continue to squeeze and release the pump bulb 2-3 more times
to allow the air to be expelled from the components; no air bubbles in the graduate (these squeezes can be softer).
Let the pump bulb completely refill before each squeeze.
CAUTION: Do not squeeze the deflation button and the pump bulb at the same time.
7. Using 3 blue shod mosquito hemostats, clamp (1 notch only) each of the 3 tubes 1 inch from the end.
Figure 4-8
S P ()

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CAUTION: Do not advance the hemostat’s ratchet more than one notch. Excessive pressure will damage the
tubing permanently.
8. For a pump treated with InhibiZone Antibiotic Surface Treatment, place the pump onto an empty sterile tray, empty
kidney basin or sterile Mayo stand- the pump 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.
9. For a non-InhibiZone treated pump, submerge the filled pump into a kidney basin of sterile normal saline or
antibiotic solution until the surgeon is ready to implant the pump.
prepare preconnected ms pump and cylInders
The AMS 700 CX Preconnect, CXR Preconnect and LGX Preconnect Penile Prosthesis cylinders and respective pumps
are provided already connected. The only connection required of the surgeon is between the pump and reservoir.
Once the surgeon has determined the proximal and distal lengths of the corpora cavernosa, choose the appropriate
preconnect cylinder and pump from inventory.
The following instructions outline the preparation of the device to ensure that the air is removed from the cylinders and
pump before the surgeon connects the reservoir.
1. Partially fill a graduate with sterile, normal saline.
2. Submerge the single, black color-coded tubing from the pump into sterile normal saline.
3. Hold the pump so the deflate mechanism is on top.
4. Squeeze the deflation button 1 time and release.
5. Make an initial hard, quick squeeze of the pump bulb. Saline should appear in the pump bulb.
Note: This step is important to lubricate the valves of the pump for further prepping.
Note: If saline does not appear in the pump bulb or if the bulb does not fully reinflate, press the deflation button 1 time
and release. This will reset the pump. Repeat Step 5. This sequence may be required more than once to get the pump
activated.
6. Following the initial squeeze, continue to squeeze and release the pump bulb until the cylinders are rounded and the
pump bulb is hard to squeeze. Let the pump bulb completely refill before each squeeze.
7. Squeeze the deflation button for 2-4 seconds to allow the air to be expelled from the components; Note: no air
bubbles in graduate.
8. Repeat steps 6 and 7 until all the air is removed from the system—that is, no bubbles are noted in the graduate
during deflation.
9. Squeeze the cylinders to remove the remaining saline from the cylinders.
CAUTION: Do not squeeze the deflation button and the pump bulb at the same time.
10. Using a blue shod mosquito hemostat, clamp (1 notch only) the black tubing 1 inch from the end.
CAUTION: Do not advance the hemostat’s ratchet more than one notch. Excessive pressure will damage the
tubing permanently.
11. For components treated with InhibiZone Antibiotic Surface Treatment place the empty
(air removed and no fluid) cylinders and pump onto an empty, non-covered sterile tray,
empty kidney basin or sterile Mayo stand—components 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.
For a non-InhibiZone treated components, submerge the empty cylinders and filled pump into a kidney basin of sterile
normal saline or antibiotic solution until the surgeon is ready to implant the cylinders.
S P ()

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prepare non-connected cylInders
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. Hold cylinder in non-dominant hand and squeeze out air.
2. Attach 15-gauge blunt tip needle to the 60 cc syringe partially filled with sterile normal
saline.
3. Use partially filled syringe to aspirate all air from the cylinder, and then slowly fill cylinder
with sterile normal saline (approximately 20-30 cc) without injecting air bubble.
- Hold the cylinder from the rear with the front tip down to allow distal portion of
cylinder to fill first (Figure 4-9).
- Inject fluid into cylinder until it is rounded out.
- Aspirate all air from cylinder with syringe.
4. You may repeat this process once if desired.
5. Aspirate all sterile normal saline and air from the cylinder until it is flat, or until the syringe plunger meets resistance.
CAUTION: Do not over aspirate to prevent air from being drawn into cylinder through its semi-permeable
silicone elastomer.
6. Holding the syringe plunger up with your thumb, clamp tubing (1 notch only) 1 inch from needle top using the
blue shod mosquito hemostat. Then remove the 15-gauge needle and syringe.
CAUTION: Do not advance the hemostat’s ratchet more than one notch. Excessive pressure may damage the
tubing permanently.
7. For a cylinder treated with InhibiZone Antibiotic Surface Treatment, place the cylinder onto an empty, non-covered,
sterile tray, empty kidney basin, or sterile Mayo stand; 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.
8. For a non-InhibiZone treated cylinder, submerge cylinder in a kidney basin of sterile normal saline or normal saline
mixed with antibiotic solution, until the surgeon is ready to implant it.
9. Prepare the other cylinder in same manner.
prepare reservoIrs
Use two 60 cc syringes with 1 cc gradations when filling the 65 ml or 100 ml reservoir.
1. Begin with reservoir in non-dominant hand and squeeze air out of reservoir.
2. Holding the reservoir, attach 15-gauge blunt tip needle and a 60 cc syringe that is partially
filled with sterile normal saline to the reservoir (Figure 4-10).
3. Use partially filled syringe to aspirate all air from reservoir.
4. After air has been removed, inject sterile normal saline (approximately 20-30 cc) without
injecting an air bubble.
5. Using your thumb press in on side of reservoir to form it into a bowl shape.
6. Aspirate all remaining saline and air out of reservoir and into syringe, stopping when syringe
plunger encounters resistance and/or reservoir makes a flattened bowl shape. Leave in the
flattened bowl shape.
Figure 4-10
S P ()
Figure 4-9

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CAUTION: Do not over aspirate to prevent air from being drawn into reservoir through its semi-permeable
silicone elastomer.
7. Holding syringe plunger up with thumb, clamp tubing (one notch only) 1 inch from the blunt needle tip using blue
shod mosquito hemostat, and remove the 15-gauge needle and syringe.
CAUTION: Do not advance the hemostat’s ratchet more than one notch. Excessive pressure may damage the
tubing permanently.
8. For a reservoir treated with InhibiZone Antibiotic Surface Treatment place the reservoir onto an empty non-covered
sterile tray, empty kidney basin, or sterile Mayo stand — 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.
9. For a non-InhibiZone treated reservoir, submerge the reservoir into a kidney basin of sterile normal saline or of
normal saline mixed with antibiotic solution until the surgeon is ready to implant it.
S P ()

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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 4-11) and Keith Needle 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.
Note: Lightning Bolt Keith Needles are included in the AMS 700 Accessory Kit.
3. Withdraw obturator to “retracted” or “locked” position. Pass both ends
of cylinders traction suture (approximately 10 cm) through the eye of a
Lightning Bolt Keith Needle (Figure 4-12).
4. Load the blunt end of this needle into the Furlow Insertion Tool
(Figure 4-13) and place suture into into slot of the tool.
5. Completely retract suture into slot and fully draw needle into barrel of
tool.
6. Hold the four strands of suture against the 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
ipsilateral side. No repair is necessary.
7. Place the penis on a mild stretch; push needle through glans by fully
inserting obturator into barrel.
8. Grasp needle with a needle holder or mosquito hemostat, and pull it
completely through glans.
9. Detach the needle from 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 distally into place from the corporotomy.
Note: Use the traction suture to guide the cylinder until the front tip is placed
well under the glans. Take care not to twist cylinder as it is being placed.
13. Carefully assess front tip position of cylinder beneath glans to verify
proper cylinder placement.
Note: Take care to leave the traction suture in place through the glans to
allow the cylinder to be repositioned. If repositioning or more dilation is
required, the cylinder should simply be pulled out of corporal body.
Figure 4-11. Furlow Insertion Tool
Figure 4-13. Load Keith Needle
Figure 4-12. Insert Traction Suture into
Keith Needle
S P ()