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