Synthes CODMAN NEURO CODMAN CERTAS Plus User manual

LCN 206521-001/J
© 2010-2017 DePuy Synthes Products, Inc.
Revised 07/17
CODMAN CERTAS® Plus
Programmable Valve
CODMAN CERTAS®
Tool Kit
(For Class II and III products, the Notified Body number is 0086)
Medos International SÀRL
Chemin-Blanc 38
2400 Le Locle, Switzerland
[phone]

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ENGLISH
Table of Contents
Description.......................................................3
Indications........................................................4
Contraindications............................................5
Warnings ..........................................................5
Precautions......................................................6
Adverse Events................................................7
Magnetic Resonance Imaging (MRI)
Safety Information...........................................7
Detailed Product Description.........................8
CODMAN CERTAS®Plus Programmable
Valve ..............................................................8
SIPHONGUARD®Device ..............................9
Accessories ...................................................9
Catheters .......................................................9
Right Angle Adapter ......................................10
Priming Adapter ............................................10
CODMAN CERTAS®Tool Kit..........................10
Description.....................................................10
Disinfecting the CODMAN CERTAS®
Tool Kit..............................................................10
How Supplied...................................................10
Storage – BACTISEAL®Catheters .................11
Pre-implantation Performance Testing .........11
Instructions for Use.........................................11
SECTION A: Pre-implantation
Adjustment Procedure...................................11
SECTION B: Surgical Procedure ...................13
Precautions ...................................................13
Irrigation.........................................................13
Surgical Technique.........................................14
SECTION C: Post-implantation
Adjustment Procedure...................................14
SECTION D: Troubleshooting ........................16
SECTION E: Confirming the Current
Valve Setting ..................................................17
SECTION F: Reading the Valve Setting
with the X-Ray Overlay Tool...........................17
Injection............................................................18
Valve Flushing (Clearing Obstructions) .........18
CODMAN CERTAS®Tool Kit Replacement ...18
Warranty ...........................................................18
Appendix A.......................................................19
Optional Manometer Testing..........................19
SIPHONGUARD®Device Functional
Testing............................................................19
Manometer Testing ........................................20

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IMPORTANT INFORMATION
Please read before use
CODMAN CERTAS®
Plus Programmable Valve
CODMAN CERTAS®Tool Kit
Valve Products, including Accessories
Certas Tool Kit
Description
The CODMAN CERTAS Plus Programmable Valve
is a single use implantable device designed for
shunting cerebrospinal fluid (CSF) for the treatment of
hydrocephalus. The valve can be set to eight different
performance settings for intraventricular pressure
and drainage of CSF. The performance setting of
the valve can be set preoperatively and can also be
noninvasively changed post-implantation by using the
CODMAN CERTAS Tool Kit. The CODMAN CERTAS Tool
Kit employs magnetic force to select one of 8 settings.
Please see Figure 1 for diagrams of the valve and
Figure 2 for diagrams of the Tool Kit.
Setting 7
Setting 6
Setting 5
Setting 4
Setting 3
Setting 2
Setting 1
Flow Rate [mL/h]
Pressure [mmH20]
Graph 1
Each CERTAS Plus Valve is calibrated and tested at the
time of manufacture. Graph 1 describes the pressure-flow
performance characteristics of the device as required
by ISO 7197:2009. In addition, long-term stability
performance of the device has been demonstrated
through testing in accordance to this standard. The
pressure shown in the graph for each setting is an
average recorded with active flow through the valve alone
at flow rates of 5, 20 and 50 mL/h; the value at 20 mL/h is
shown. Note that testing of the device may give different
results depending on the test conditions.
The devices performed within a tolerance range of
the average pressure as shown here regardless of
gravitational orientation:
Settings 1, 2, 3 ±20 mmH2O
Setting 4 ±25 mmH2O
Settings 5, 6, 7 ±35 mmH2O

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When adjusting the valve, the changes between each
performance setting at flow rates of 5, 20, and 50 mL/h are:
Incremental steps between
settings 1,2,3,4 15 – 40 mmH2O
Incremental steps between
settings 4,5,6,7 20 – 50 mmH2O
Setting 8 is intended to limit flow through the valve and
has an average pressure greater than 400 mmH2O.
When tested with a 120 cm long, 1 mm ID Distal Catheter
the average pressure increase is dependent on flow rate
as shown here:
5 mL/h 6 mmH2O
20 mL/h 21 mmH2O
50 mL/h 50 mmH2O
Intraventricular pressure is maintained at a constant
level by the ball and cone valve seat design. The ball is
manufactured of synthetic ruby, as is the matching cone.
Together these components provide a precise fit for
regulating the flow of CSF through the valve.
The SIPHONGUARD®Device, included in some models
of the valve, is designed to prevent excessive drainage
of CSF by the shunt system. Excessive draining can
be induced by a rapid increase in hydrostatic pressure
created by the elevation of the shunt ventricular catheter
with respect to the shunt distal catheter (i.e., when
patient moves from a supine to an upright position).
Graph 2 describes the pressure-flow performance
characteristics of the valve with SIPHONGUARD device.
Additional Pressure Needed To Maintain Flow [mmH2O]
Flow Rate [mL/hr]
Graph 2
The BACTISEAL®Catheters, included in some models
of the valve, are subjected to a treatment process by
which the silicone is impregnated with rifampin and
clindamycin hydrochloride. The BACTISEAL Silicone
Catheters have been shown to reduce the colonization
of gram positive bacteria on the tubing surface.
The CODMAN CERTAS Tool Kit must be used to adjust
the valve setting. It can also be used to confirm the
setting. The CODMAN CERTAS Tool Kit is available
separately (See Detailed Product Description).
Indications
The CODMAN CERTAS Plus Programmable Valve
is an implantable device that provides constant
intraventricular pressure and drainage of CSF for the
management of hydrocephalus.
The CODMAN CERTAS Tool Kit allows the noninvasive
reading or adjustment of the valve setting.

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Contraindications
These devices are contraindicated in patients receiving
anticoagulants or known to have a bleeding diathesis.
Avoid shunt implantation if infection is present within the
body. Delay the shunt procedure when infections such
as meningitis, ventriculitis, peritonitis, bacteremia, and
septicemia are present.
The BACTISEAL Catheters are contraindicated in
patients with known hypersensitivity to rifampin or
clindamycin hydrochloride.
Warnings
• Choose an implantation site for the valve where
the tissue over the valve is not too thick (i.e. tissue
thickness <10 mm). Otherwise locating, reading,
and adjusting the valve with the tool kit may be
difficult (i.e.; multiple attempts may be required) or
impossible. If unable to adjust the valve, the valve
will maintain a constant operating pressure and the
patient should be informed of this risk. Please refer
to SECTION D: Troubleshooting should any difficulty
in programming occur.
• As with all programmable valves, the magnets within
the CERTAS Plus valve will cause an image artifact
on CT and MRI imaging. As a result, the implantation
site should be chosen so that the artifact will be
minimized in areas of significant clinical interest,
such as a tumor, that may require repeated future
imaging assessment.
• Testing shows that the valve mechanism is resistant
to unintended changes in the setting in a 3 Tesla
MRI. However, the clinician should confirm the valve
setting after a magnetic resonance imaging (MRI)
procedure. See SECTION C: Post-implantation
Adjustment Procedure Steps 1 through 6.
• The valve setting is adjusted with the application
and manipulation of strong magnets. A change to
the valve setting is unlikely to occur under normal
circumstances. However, magnetic fields should not
be placed in close proximity to the valve due to the
possibility of an unintentional setting change.
• Read MRI Information before performing an MRI
procedure on a patient implanted with the valve.
• Any magnet may experience a degradation of
magnetic field strength as a consequence of
exposure to the significantly stronger magnet field
induced in an MRI procedure.
oBased on the coercivity of the CERTAS Plus
magnet material, the valve is resistant to magnetic
degradation in a 1.5T MRI.
oTesting of the CERTAS Plus valve following
exposure to 10 simulated MRI procedures at 3T
indicates there is no substantial demagnetization
or significant reduction in programmability. Please
refer to SECTION D: Troubleshooting should any
difficulty in programming occur.
• Do not interchange the CODMAN CERTAS
Tool Kit (82-8851) components with the
CODMANCERTAS Therapy Management System
TMS (82-8850)components.

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• The Indicator Tool has a precise operating
mechanism and is vulnerable to damage if
mishandled. Store and carry all components of
the Tool Kit in the storage case when not in use
to prevent damage. Replace the Indicator Tool
immediately if dropped (or suspected of being
dropped) to ensure accurate performance.
Replacement Indicator Tools are available from
your local Codman representative.
Precautions
• Inspect the sterile package carefully. Do not use if:
–the package or seal appears damaged,
–contents appear damaged, or
–the expiry date has passed.
• Use sterile technique in all phases of handling the
valves and accessories.
• Use only with catheters that are compatible with
the dimensions shown in the Detailed Product
Description section.
• Ventriculoatrial (VA) shunting could be considered in
patients when:
operitoneal CSF absorption is impeded and
alternative sites for shunting are necessary
othe patient presents with peritoneal adhesions,
pseudocysts or dialysis catheters
• Surgeons should consider the additional risks and
benefits prior to considering a VA shunt:
oin patients with cardiopathies or other
malformations of the cardio-pulmonary system
oin children, VA distal catheter location is more
crucial for proper function, since rapid growth
may cause cephalad migration of the tip over time
• The safety and effectiveness of Bactiseal catheters
for VA shunting has not been established.
• Carefully monitor the patient during the first
24 hours after adjusting the valve setting. It is
recommended that each adjustment be limited to an
increase or a decrease of one setting, since setting
changes can range between 15 and 50 mmH2O.
• Confirm the valve performance setting after an
MR procedure.
• Use only the CODMAN CERTAS Tool Kit to adjust
the setting of the CODMAN CERTAS and CODMAN
CERTAS Plus Programmable Valves.
• Do not use any of the CODMAN CERTAS Tool Kit
components on a metal surface, such as a Mayo stand
as this could interfere with the Indicator Tool magnets.
Note: The Adjustment Tool contains powerful magnets.
• Inspect the CODMAN CERTAS Tool Kit components
before each use. Check for damage, such as cracks.
Do not use the Tool Kit if damage is present. Contact
your local Codman sales representative for a
replacement kit.
• Excessive swelling may make it difficult to
determine and/or adjust the performance setting.
oSee Step 4 in SECTION C: Post-Implantation
Adjustment Procedure for instructions for using
the Low Profile Locator Tool in these instances.
oIf difficulty correctly positioning both Locator
Tools persists, wait until the swelling is reduced
or confirm the valve setting with x-ray. See
SECTION E: Confirming the Current Valve
Setting for more information.
• Failure to accurately position the Locator Tool could
result in an inaccurate indication of the performance
setting, potentially leading to a false reading (i.e. an

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incorrect number may appear in the window of the
Indicator Tool). The Locator Tool must be precisely
aligned with both the valve’s direction of flow and the
center of the hard valve mechanism for an accurate
indication reading. Alignment can be more challenging
if tissue thickness is >10 mm above the valve. In
these instances, verify the valve setting with x-ray or
fluoroscopy. See SECTION D: Troubleshooting and
SECTION E: Confirming the Current Valve Setting.
Adverse Events
Devices for shunting CSF might need to be replaced at
any time due to medical reasons or failure of the device.
Keep patients with implanted shunt systems under close
observation for symptoms of shunt failure.
Complications of implanted shunt systems include
mechanical failure, shunt pathway obstruction, infection,
foreign body (allergic) reaction to implants, and CSF
leakage along the implanted shunt pathway.
Clinical signs such as headache, irritability, vomiting,
drowsiness, or mental deterioration might be signs of a
nonfunctioning shunt. Low-grade colonization, usually
with Staph. epidermidis, can cause, after an interval from
a few days to several years, recurrent fevers, anemia,
splenomegaly, and eventually, shunt nephritis or pulmonary
hypertension. An infected shunt system might show
redness, tenderness, or erosion along the shunt pathway.
Accumulation of biological matter within the valve can:
• cause difficulties adjusting the valve setting with the
Tool Kit
• impair the antireflux function
Adjusting the valve to a performance setting that
is lower than necessary can lead to excessive CSF
drainage, which can cause subdural hematomas, slit-like
ventricles, and in infants, sunken fontanels.
The ventricular catheter can become obstructed by:
• Biological matter
• Excessive reduction of ventricle size
• Choroid plexus or ventricular wall
• Fibrous adhesions, which can bind the catheter to
the choroid plexus or ventricular wall
If fibrous adhesions cause the catheter to become
obstructed, use gentle rotation to free the catheter. Do not
remove the catheter with force. If the catheter cannot be
removed without force, it is recommended that it remain in
place, rather than risk intraventricular hemorrhage.
The ventricular catheter can be withdrawn from, or
lost in, the lateral ventricles of the brain if it becomes
detached from the shunt system.
Blunt or sharp trauma to the head in the region of
implant or repetitive manipulation of the implanted valve
might compromise the shunt. Check valve position and
integrity if this occurs.
Magnetic Resonance Imaging (MRI) Safety
Information
The CODMAN CERTAS Tool Kit is considered “MR
Unsafe” in accordance with the American Society for
Testing and Materials (ASTM) Standard F2503-13.

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CAUTION: Do not use the CODMAN CERTAS Tool Kit
in the MR suite.
MR Conditional
The CODMAN CERTAS Plus Programmable Valve
is MR Conditional. Non-clinical testing demonstrated
that the CODMAN CERTAS Plus Programmable Valve
is MR Conditional. A patient with this device can be
scanned safely, immediately after placement under the
following conditions:
• Static magnetic field of 3-Tesla and 1.5-Tesla
• Maximum spatial gradient magnetic field of
1,000 Gauss/cm (extrapolated) or less.
Note: The highest SG magnetic field is commonly
located off-axis, at a side wall, and near the opening
of the bore of the scanner. Please refer to MRI
manufacturers published value and location of the
peak SG that is accessible to the patient.
• Maximum MR system reported, whole body
averaged specific absorption rate (SAR) of 4-W/kg
for 15 minutes of scanning (i.e., per pulse sequence)
in the First Level Controlled Operating Mode of
operation for the MR system.
MRI-Related Heating
In non-clinical testing, the CODMAN CERTAS Plus
Programmable Valve produced the following temperature
rise during MRI performed for 15-min of scanning
(i.e., per pulse sequence) in a 1.5-Tesla system
1.5-T/63.86MHz, MITS 1.5, Software MITS1.2.1,
ZurichMed Tech:
MR system reported,
whole body averaged SAR 4-W/kg
Calorimetry measured values,
whole body averaged SAR 3.17-W/kg
Highest temperature change 2.1°C
Temperature scaled to whole
body averaged SAR of 4-W/kg 2.6°C
Artifact Information
The maximum artifact size as seen on the gradient echo
pulse sequence at 3-Tesla extends approximately 25-mm
relative to the size and shape of the CODMAN CERTAS
Plus Programmable Valve.
Specific Guidelines
The valve setting should be verified after the MRI
procedure (See Section C: Post-implantation Adjustment
Procedure Steps 1 through 6).
Detailed Product Description
CODMAN CERTAS Plus Programmable Valve
The valve features an adjustable mechanism and an
inline reservoir. All valves are marked with a radiopaque
direction-of-flow arrow and a right hand side (RHS)
marker. A priming adapter is included with all valves.
Valves are available with or without a SIPHONGUARD
Device. Valves are also available with or without
accessories, including silicone catheters or BACTISEAL
Catheters. See Figure 1.

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The valves are designed for use with catheters having
the following dimensions:
Inner Outer
Component Diameter Diameter
Ventricular catheter 1.4 mm 2.7 mm
Distal catheter 1.0 mm 2.2 mm
SIPHONGUARD Device
The SIPHONGUARD Device is supplied with some
models of the valve. CSF flows through the valve and
enters the SIPHONGUARD Device, where it flows into
two internal passages. Under normal conditions, the
majority of CSF flows through a central ruby ball and
cone valve, and exits directly out of the distal port of
the SIPHONGUARD Device. The remaining CSF travels
through a spiral passage that surrounds the central
passage, distal to the ball and cone valve.
A sudden increase in CSF flow will close the ball and
cone valve and the entire volume of CSF will be forced
through the longer spiral passage, effectively slowing
the rate at which CSF is shunted from the brain. Once
the flow rate entering the SIPHONGUARD Device
decreases, the ruby ball separates from the valve seat,
opening the central passage. As long as CSF continues
to be shunted from the ventricles, flow through the spiral
passage of the SIPHONGUARD Device never stops,
regardless of the patient’s position. See Graphs 1 and 2
for pressure flow characteristics.
Note: The SIPHONGUARD Device will not activate at
low CSF flow rates.
The SIPHONGUARD Device has a rigid enclosing shell
of polyethersulfone to prevent inadvertent closure
(and subsequent reduction or blockage of CSF flow)
caused by externally applied pressure.
Accessories
Accessory components supplied with some models of
the valve include:
Ventricular catheter
Distal catheter (unitized or separate)
Right angle adapter
Priming adapter
Catheters
The ventricular catheter is a 14 cm straight ventricular
catheter molded of radiopaque silicone elastomer with
x-ray detectable dots and a preassembled stainless steel
introducing stylet.
The distal catheter is 120 cm long, molded of radiopaque
silicone elastomer with x-ray detectable dots.
The BACTISEAL Catheters that are supplied with
some models of the valve are made of radiopaque
barium-impregnated silicone tubing that is subjected
to a process by which the silicone is impregnated with
rifampin and clindamycin hydrochloride.
The quantities of rifampin and clindamycin hydrochloride
used to impregnate the catheters are only a small
fraction of a therapeutic dose of these two antibiotics,
and have no potential for systemic therapeutic effect.
BACTISEAL Catheters are also available separately.

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Right Angle Adapter
The right angle adapter, made of PROLENE®Material,
allows 90 degree bending of the ventricular catheter at
the burr hole site.
Priming Adapter
The priming adapter with inlet tubing facilitates pre-
implantation irrigation of the valve and catheters.
CODMAN CERTAS Tool Kit
Description
The CODMAN CERTAS Tool Kit is used to adjust and
confirm the performance setting of a CODMAN CERTAS
or CODMAN CERTAS Plus Programmable Valve. The
actions are performed both preoperatively (with the
valve still in the sterile package) and postoperatively
(on the implanted valve) through noninvasive means.
The CODMAN CERTAS Tool Kit employs magnetic force
to change the performance setting.
The CODMAN CERTAS Tool Kit (See Figure 2A) consists
of five components:
• Adjustable Height Locator Tool
• Low Profile Locator Tool
• Indicator Tool
• Adjustment Tool
• X-Ray Overlay Tool
These components are packaged within a case (See
Figure 2B) that, when closed, will help minimize the effect
of the CODMAN CERTAS Tool Kit magnets on other items.
The CODMAN CERTAS Tool Kit is provided separately as
a non-sterile product:
Catalog No. Description
82-8851 CODMAN CERTAS Tool Kit
CAUTION: Do not sterilize the CODMAN CERTAS
Tool Kit.
Disinfecting the CODMAN CERTAS Tool Kit
After use, wipe the areas of the tools that contact the
patient with a combination wipe (Quaternary Ammonium/
Isopropyl Alcohol). Follow Steps 1 through 4 below.
1. Thoroughly wet the surfaces with a wipe.
2. Keep the surfaces wet for 2 minutes. Use as many
wipes as needed to keep the surfaces wet for the
entire 2 minutes.
3. Allow the wetted surfaces to air dry.
4. Inspect the components to ensure that all soil, blood,
or debris has been removed. If needed, repeat Steps 1
through 3 and inspect again.
Visually inspect all parts after disinfection to ensure
markings remain. Do not use the Tool Kit components if
markings are compromised. Contact your local Codman
sales representative for a replacement kit.
How Supplied
The valve and its accessories are for SINGLE USE
ONLY; DO NOT RESTERILIZE. Codman Neuro single
use devices have not been designed to undergo or
withstand any form of alteration, such as disassembly,
cleaning, or re-sterilization, after a single patient use.

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These devices are intended to come into contact
with the central nervous system and the ability does
not currently exist to destroy possible contaminates,
such as Creutzfeldt-Jakob Disease. Reuse might also
compromise device performance and any usage beyond
the design intent of this single use device might result in
unpredictable use hazards or loss of functionality.
Codman Neuro will not be responsible for product that is
re-sterilized, nor accept for credit or exchange product
that has been opened but not used.
As long as the inner unit of the valve package is not
opened or damaged, the product is sterile.
Testing has shown that the following components
are nonpyrogenic:
• Valve and Valve with SIPHONGUARD Device
• Ventricular catheter (both BACTISEAL Catheters and
non-treated catheters)
• Distal catheter (both BACTISEAL Catheters and non-
treated catheters)
• Right angle adapter
• Priming adapter
Storage – BACTISEAL Catheters
Store any valve kits that contain BACTISEAL Catheters
at temperatures between 2°C (36°F) and 27°C (81°F),
away from direct light. Do not remove the product
from the packaging until it will be used. The shelf life
of products containing BACTISEAL Catheters is one
year from the date of sterilization. The “Use By” date
is indicated on the labeling; the product can be used
through the last day of the month shown.
Pre-implantation Performance Testing
Every CODMAN CERTAS Plus Programmable Valve
is calibrated during manufacture and is tested for
proper performance.
Performing manometer testing is not recommended for
the following reasons:
• The concentration of antibiotics in the BACTISEAL
Catheters can be reduced by the testing.
• Customer-performed testing is susceptible to
environmental factors.
• The results yielded are not physiologic in nature.
If the surgeon insists upon performing manometer
testing for confirmation of valve closing pressures,
please see Optional Manometer Testing in Appendix A.
Instructions for Use
Note: Additional training materials are available from
your local Codman sales representative.
SECTION A: Pre-implantation
Adjustment Procedure
Adjust the performance setting before implanting
the CERTAS Plus Programmable Valve. This step is
performed before the sterile inner package is opened.
1. Place the valve sterile package on a non-metallic
surface so the clear portion of the package faces up.
Place the Adjustable Height Locator Tool in the
circular grooves of the package so that the arrow on
the tool points in the same direction as the arrows
molded into the plastic package (See Figure 3).
Ensure that the Adjustable Height Locator

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Tool is fully seated in the grooves. If necessary,
maintain hold of the Adjustable Height Locator
Tool throughout the procedure to keep it firmly in
the grooves of the package.
CAUTION: Failure to maintain a fully-seated
Locator Tool above the valve mechanism
could result in an inaccurate indication of the
performance setting.
Note: Do not use the Low Profile Locator Tool for
programming the valve in the package, as it does not
contain a base that will fit into the circular grooves of
the packaging.
2. Fully seat the Indicator Tool into the Adjustable
Height Locator Tool so that the red markings are
aligned (Figure 4). You may hear a click when the tool
seats; the Indicator Tool will not rotate within the
Locator Tool when properly seated.
CAUTION: When reading the performance setting
with the Indicator Tool, make sure that the
Adjustment Tool and any other magnetic devices
are at least 36 cm (14 in.) away from the Indicator
Tool. Failure to do so can result in an inaccurate
indication of the performance setting.
3. When the number dial on the Indicator Tool stops
moving, observe the number and its position within the
window to determine the performance setting. A single
number within the window, with full purple background
and both gray side lines visible (Figure 13), indicates
the performance setting of the valve when the tools are
properly aligned. Once the valve performance setting
has been read, remove the Indicator Tool.
4. Insert the Adjustment Tool into the Adjustable
Height Locator Tool so that the arrow is pointing
to the current performance setting. With one hand
holding the “petals” of the Adjustable Height
Locator Tool, turn the Adjustment Tool with the
other hand until the arrow points to the desired
performance setting (Figure 5). The Adjustment Tool
will provide an audible click and a tactile response as
you turn to each setting.
Note: The Adjustment Tool is equipped with a
mechanical stop between Settings 1 and 8. This is to
prevent inadvertent adjustment between the extremes
of the available settings.
Note: Successful adjustment is accomplished by
starting at the valve’s current setting and moving
directly to the desired setting.
5. Remove the Adjustment Tool from the Adjustable
Height Locator Tool by lifting it straight upwards a
minimum of 3 cm (1.25 in.) before moving it horizontally
away from the Adjustable Height Locator Tool in
order to avoid inadvertently changing the valve setting.
6. Repeat Steps 2 and 3 to confirm successful
adjustment of the performance setting. Always
confirm the desired performance setting of the valve.
7. If the desired performance setting is not achieved,
repeat Steps 4 through 6.
8. It is recommended to record the valve setting in the
patient’s record and I.D. wallet card (available from
local Codman sales representative).

13
9. Return all tools to the storage case to prevent damage.
Note: fully collapse the Adjustable Height Locator
Tool (See Figure 2B).
SECTION B: Surgical Procedure
Precautions
• Silicone has a low cut and tear resistance; therefore,
exercise care when placing ligatures so as not to tie
them too tightly. The use of stainless steel ligatures
on silicone rubber is not recommended.
• Do not use sharp instruments when handling the
silicone valve or catheter; use shod forceps. Cuts or
abrasions from sharp instruments might rupture or
tear the silicone components.
• Do not fold or bend the valve during insertion.
Folding or bending might cause rupture of the
silicone housing, needle guard dislodgement,
or occlusion of the fluid pathway.
• Verify proper placement and integrity of ligatures
at all tubing junctions to prevent obstruction of
the catheter lumen and tears or abrasions of the
silicone tubing.
• Exercise extreme care to prevent the silicone
components of the system from coming in contact
with towels, drapes, talc, or any linty or granular
surfaces. Silicone rubber is highly electrostatic and,
as a result, attracts airborne particles and surface
contaminants that could produce tissue reaction.
• Do not immerse the BACTISEAL Catheter in
antibiotic solutions. When immersing the catheter
in sterile water or saline, keep immersion time to a
minimum. A pale orange color might be imparted to
the immersion solution. Manometer testing of the
valve with BACTISEAL Catheter is not advised.
Irrigation
It is required that the valve be irrigated before
implantation to help ensure proper performance.
1. Hold the valve vertically with the distal connector
barb pointing downward.
2. Using a syringe, slowly and gently fill the entire valve
system with pyrogen-free, sterile saline solution or,
for catheters other than BACTISEAL Catheters, an
appropriate antibiotic solution. Once fluid begins
flowing through the valve mechanism, the distal
connector barb of the valve can be pointed upward to
assist in evacuating air from the system.
Note: A priming adapter with inlet tubing is provided
to facilitate irrigation.
CAUTION: Do not fill, flush, or pump the valve with
fluid in which cotton, gauze, or other lint-releasing
material has been soaked.
Note: More pressure might be required on the syringe
before fluid starts flowing through the valve mechanism.
This is normal and will only occur during initial irrigation
of the valve. A popping sound may occur.
Note: The SIPHONGUARD device is intended to
reduce the rapid flow of CSF. It also reduces the
ability to prime the shunt system during implantation
to a rate of approximately 0.5 mL/minute.

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3. Once fluid flows from the distal connector barb of the
valve (or the distal catheter, on unitized models), and
air has been evacuated from the valve, remove the
syringe and the priming adapter (if used).
Surgical Technique
There are a variety of surgical techniques that can be
used to place the valves. The surgeon should choose
in accordance with his or her own clinical experience
and medical judgment. It is required that the valve
be irrigated as outlined in Irrigation, to help ensure
proper performance.
CAUTION: Placement of the valve can impact the
performance of the tool kit and should be taken
into account for proper patient therapy. Select a
location where the implanted valve can be positioned
horizontally for use with the tool kit (See Figure 6).
Avoid placement too close to structures, such as the
ear. It is also important to choose an implantation site
where the tissue over the valve is not too thick (>10 mm)
otherwise locating, reading and adjusting with the
CODMAN CERTAS Tool Kit may not be possible.
It is recommended to record the setting of the valve
in the patient records and on the patient I.D. wallet
card. Labels are provided with each valve to record the
product lot number information in the patient records.
I.D. wallet cards are available from the local Codman
sales representative.
SECTION C: Post-implantation
Adjustment Procedure
Adjust the valve at any time after the implantation
surgery. If needed, apply a sterile drape over the incision
site. The drape will not interfere with the magnetic
coupling of the adjustment procedure.
CAUTION: Excessive swelling or thick tissue may make
it difficult to determine and/or adjust the performance
setting. See Step 4 in this section for instructions for
using the Low Profile Locator Tool in these instances.
If difficulty correctly positioning both Locator
Tools persists, wait until the swelling is reduced or
confirm the valve setting with x-ray. See SECTION D:
Troubleshooting and SECTION E: Confirming the
Current Valve Setting for more information.
1. Position the patient so that the implanted valve
and tools are horizontal, to optimize Indicator Tool
performance (See Figure 6).
CAUTION: If Indicator Tool is not horizontal, an
inaccurate reading might result.
2. Locate the valve by palpation. Palpate and mark the
center of the valve mechanism i.e., the hard portion
of the valve distal to the reservoir. Palpate and mark
the position of the inlet and outlet connector barbs/
catheters (See Figure 7).
3. Select the appropriate Locator Tool (Adjustable
Height Locator Tool or Low Profile Locator Tool).
If the tissue in the area of the valve is thick tissue or
if edema is present (>10 mm above the valve), use
the Low Profile Locator Tool (Figure 8). Otherwise,
use the Adjustable Height Locator Tool. Optimal
placement is achieved when the selected Locator
Tool is stable on the patient’s head and the tissue that
covers the valve mechanism is just below the cut-out
in the Locator Tool (Figures 9A and 9C).

15
4. Place the appropriate Locator Tool atop the
implanted valve so that the black lines are aligned
with the marked center of the hard valve mechanism
and the direction of flow arrow aligns with the
catheter barb marks (Figure 10).
Note: If using the Adjustable Height Locator Tool,
rotate the white outer ring to adjust the height until
the tissue that covers the valve mechanism is just
below the cut-out in the Locator Tool (Figure 9C) to
optimize the tool performance.
Note: If using the Low Profile Locator Tool, ensure
that the tissue that covers the valve mechanism does
not protrude through the cut-out in the Locator Tool.
If tissue is protruding through the opening, gently
hold the tool against the head to see if the tissue
stays below the cut-out. If there is too much tissue
protrusion, use the Adjustable Height Locator
Tool instead.
CAUTION: Failure to accurately position the
Locator Tool could result in an inaccurate
indication of the performance setting, potentially
leading to a false reading (i.e. an incorrect number
may appear in the window of the Indicator Tool).
The Locator Tool must be precisely aligned
with both the valve’s direction of flow and the
center of the hard valve mechanism for an
accurate indication reading. Alignment can be
more challenging if tissue thickness is >10 mm
above the valve. In these instances, verify the
valve setting with x-ray or fluoroscopy. Refer to
SECTION D: Troubleshooting and SECTION E:
Confirming the Current Valve Setting.
5. Fully seat the Indicator Tool into the Locator Tool
so that the red markings are aligned (Figure 11). You
may hear a click when the tool seats. The indicator
tool will not rotate within the locator tool when
properly seated.
CAUTION: When reading the performance setting
with the Indicator Tool, make sure that the
Adjustment Tool and any other magnetic devices
are at least 36 cm (14 in.) away from the Indicator
Tool. Failure to do so can result in an inaccurate
indication of the performance setting.
6. When the number dial on the Indicator Tool stops
moving, observe the number and its position within
the window to determine the performance setting.
A single number within the window that has the full
purple background and both gray side lines visible
(Figure 13) indicates the performance setting of the
valve when the tools are properly aligned. Once the
valve performance setting has been read, remove the
Indicator Tool.
Note: If a single number with the purple background
and both gray side lines are not fully visible, then
the Locator Tool is not accurately aligned with the
valve. Remove the Indicator Tool and reposition
the Locator Tool, ensuring the black center lines
are centered with the valve mechanism (Figure 10).
Repeat Steps 1 through 6.
CAUTION: Do not move the Locator and Indicator
Tools together to obtain or center a number in
the window as this could result in an inaccurate
indication of the performance setting.

16
7. Insert the Adjustment Tool into the Locator Tool so
that the arrow is pointing to the current performance
setting. With one hand holding the “petals” of the
Locator Tool, turn the Adjustment Tool with the
other hand until the arrow points to the desired
performance setting (Figure 12). The Adjustment Tool
will provide an audible click and a tactile response as
you turn to each setting.
CAUTION: Failure to accurately position the
Locator Tool could result in an inability to adjust
the performance setting. The Locator Tool must be
precisely aligned with both the valve’s direction of
flow and the center of the hard valve mechanism
for an accurate adjustment. Alignment can be more
challenging if tissue thickness is >10 mm above the
valve. In these instances, verify the valve position
and orientation with x-ray or fluoroscopy. Refer
to SECTION D: Troubleshooting and SECTION E:
Confirming the Current Valve Setting.
Note: The Adjustment Tool is equipped with a
mechanical stop between Settings 1 and 8. This is to
prevent inadvertent adjustment between the extremes
of the available settings.
Note: Successful adjustment is accomplished by
starting at the valve’s current setting and moving
directly to the desired setting.
8. Remove the Adjustment Tool from the Locator
Tool by lifting it straight upwards a minimum of 3 cm
(1.25 in.) before moving it horizontally away from the
Locator Tool in order to avoid inadvertently changing
the valve setting.
9. Repeat Steps 7 and 8 to confirm successful
adjustment of the performance setting. Always
confirm the desired performance setting of the valve.
10. If the desired performance setting is not achieved,
repeat Steps 7 through 9.
11. It is recommended to record the valve setting in the
patient’s record and I.D. wallet card (available from
local Codman sales representative).
12. Disinfect the tool kit components (See Disinfecting
the CODMAN CERTAS Tool Kit).
13. Return all tools to their proper locations in the
storage case to prevent damage.
Note: place the Low Profile Locator Tool under the
elastic webbing in the bottom of the storage case
and fully collapse the Adjustable Height Locator
Tool (See Figure 2B).
SECTION D: Troubleshooting
If valve function is adversely affected by accumulations
of biological matter, it might be possible to dislodge the
material and restore proper function through one of the
following methods:
• flushing and/or pressing the valve (only for those
valves without the SIPHONGUARD feature)
• multiple attempts to adjust the setting
If there is difficulty in indicating and/or adjusting the
valve setting:

17
• To optimize Indicator Tool performance, ensure that
the patient is positioned so that the valve is horizontal
and the tool kit components are used horizontally.
See Figure 6.
• Use fluoroscopy or x-ray to locate the position and
orientation of the valve mechanism for adjustment and/
or to determine the performance setting of the valve.
A fiducial mark may be helpful for this technique.
It may be challenging to get the correct position of the
Locator Tool above the implanted valve. Consider using
the Low Profile Locator Tool.
• Palpate to feel for the hard valve mechanism and
make sure the black lines on the Low Profile
Locator Tool are aligned with the center of the
valve mechanism.
• Mark the patient’s skin in the center of the valve
mechanism between the two black lines. Also mark
the location of the valve barbs/catheters on the
proximal and distal ends (See Figure 7). This will
facilitate the proper position and orientation of either
Locator Tool above the implanted valve.
• Make sure the black lines on the Locator Tool line up
with the mark for the center of the valve mechanism
and that the direction of flow arrow is aligned with the
marks for the proximal and distal barbs/catheters.
If these remedial steps fail to rectify the problem, replace
the valve.
SECTION E: Confirming the Current
Valve Setting
The setting of an implanted valve can be determined
by using the CODMAN CERTAS Tool Kit, and following
SECTION C: Post-Implantation Adjustment Procedure,
Steps 1 through 6.
An alternate method is to x-ray the valve. A proper x-ray
is generated when the film is shot perpendicular to the
plane of the valve with the non-implanted side of the
patient’s head resting on the plate. The film must be taken
in relation to the valve and not the patient’s anatomy. See
Figure 14 for x-ray views of the valve at each setting.
When viewing the x-ray film or screen to confirm
the valve setting, use the X-Ray Overlay Tool (See
SECTION F: Reading the Valve Setting with the X-Ray
Overlay Tool, Steps 1–5).
SECTION F: Reading the Valve Setting with the
X-Ray Overlay Tool
See Figure 15.
Note: Position the X-Ray Overlay Tool flush against the
x-ray image.
1. Align RED centerline of valve on overlay with the
centerline of the valve x-ray under review. This
can be accomplished by aligning the proximal and
distal connectors of the x-ray image with those on
the overlay.
2. Ensure that the numbers on the overlay that depict
the performance settings are properly oriented for
viewing. In this orientation the right hand side (RHS)
marker red line extends to the right of the RED
centerline. This ensures proper overlay orientation.
3. Align rotating construct (RC) center dot on overlay
with the center of the RC of the x-ray image.

18
4. Ensure RHS marker red line containing red dot is aligned
with the RHS marker of the x-ray image (if present).
5. The valve setting is determined by identifying the
region of the overlay that contains the majority of
the image of the magnet that has the tantalum ball
adjacent to it.
Injection
If hypodermic injection is required, inject with a 25-gauge
or smaller non-coring HUBER®type needle into the
reservoir only. The reservoir can be punctured up to
25 times with a 25-gauge or smaller non-coring HUBER
type needle.
CAUTION: A needle guard has been included in the
valve housing to provide tactile feedback during
needle insertion but is not intended to prevent
puncturing through the back of the valve under
forceful pressure.
Valve Flushing (Clearing Obstructions)
(Valves without SIPHONGUARD Device only)
CAUTION: While flushing may be used as a method
for determining patency, it is not recommended.
Use clinical judgment and imaging studies or
other techniques to confirm suspected cases of
shunt malfunction.
To flush the ventricular (proximal) catheter:
• Occlude the catheter distal to the reservoir with finger
pressure, then depress the reservoir.
• Failure of the reservoir to refill might indicate proximal
catheter blockage.
To flush the distal catheter:
• Occlude the catheter proximal to the reservoir with
finger pressure, then depress the reservoir.
• Failure of the reservoir to depress easily might indicate
distal catheter blockage.
Note: While proximal pressure is maintained, reservoir
will not refill with fluid.
CODMAN CERTAS Tool Kit Replacement
The CODMAN CERTAS Tool Kit cannot be repaired.
Contact your local Codman representative for
replacement of the CODMAN CERTAS Tool Kit.
Warranty
Codman Neuro warrants that this medical device is
free from defects in both materials and workmanship.
Any other express or implied warranties, including
warranties of merchantability or fitness, are hereby
disclaimed. Suitability for use of this medical device
for any particular surgical procedure should be
determined by the user in conformance with the
manufacturer’s instructions for use. There are no
warranties that extend beyond the description on
the face hereof.
® CODMAN, CERTAS, SIPHONGUARD and BACTISEAL are
registered trademarks of DePuy Synthes
® PROLENE is a registered trademark of Ethicon, Inc.
® HUBER is a registered trademark of Becton, Dickinson, and Co.

19
Appendix A
Optional Manometer Testing
Although Codman does not recommend functional
testing, some surgeons might choose to do so. Before
testing, it is extremely important that a CODMAN CERTAS
Programmable Valve with or without SIPHONGUARD
Device be flushed of all air bubbles. Air bubbles within the
valve or SIPHONGUARD Device will produce inaccurate
manometer test results. The presence of air bubbles can
reduce the cross-sectional area of the flow path, increase
system resistance, and impede the flow of fluid through
the system during testing.
SIPHONGUARD Device Functional Testing
Equipment Required (use all sterile equipment, perform
testing under sterile conditions)
One sterile manometer, wide-bore (e.g. 3.5 mm),
graduated in mm (available in lengths from 38 to 60 cm)
One sterile 4-way stopcock
One sterile syringe, 10mL minimum is recommended
One sterile syringe filter, 5 µm
Sterile tubing adapters
Sterile silicone tubing
One sterile male luer connector with 1/16 in. (1.6 mm) barb
Sterile saline solution
Flushing Procedure
Note: At a rate of 0.5 mL/minute, unitized versions
require 2–3 minutes to complete flushing. This is the
time required for fluid to fill the valve and exit the distal
catheter. Allot additional time to ensure the system is
free of air bubbles.
1. Fill syringe with sterile saline using the 5 µm syringe
filter. The syringe filter should not be reused in any
subsequent refilling of the syringe. Once the syringe
has been filled, remove the filter from the syringe.
2. Assemble manometer, stopcock, syringe, and tubing
(Figure A-1).
3. Adjust the valve setting to 1 while the valve remains in
its sterile package.
4. Remove valve from the sterile package, and connect
the valve to the manometer/syringe assembly.
5. Adjust the stopcock to connect the syringe to the
valve assembly (Figure A-2).
6. Position the valve vertically with the outlet
pointed downward.
7. Using the syringe, gently flush saline through the
system while gently pressing the reservoir to purge air
bubbles from the valve assembly. Once fluid begins
flowing through the valve mechanism, the outlet of
the valve can be pointed upward to further assist in
evacuating air from the system.
Note: An excessive flow rate (>0.75 mL/min)
activates the SIPHONGUARD Device and creates
the impression that the valve is distally occluded. In
reality, flow is being diverted to the high resistance
secondary pathway.
8. Attach a distal catheter to the valve and gently flush
saline through the system to ensure that the catheter
is purged of air.

20
9. The device is now ready for SIPHONGUARD Device
Test Procedure or Manometer Testing.
Note: All valves are susceptible to damage due to
excessive flow rate during testing. Take extreme care
when flushing a valve as damage can occur when
excessive flow rates are used. It is recommended to
use a flow rate of no greater than 0.5 mL/min.
SIPHONGUARD Device Test Procedure
Note: This procedure applies only to valves with an
integrated SIPHONGUARD Device.
Note: Perform this procedure immediately after
completing the flushing procedure. This procedure
is designed to provide visual confirmation of proper
functioning of the SIPHONGUARD Device.
1. Use a full syringe of saline solution attached to the
4-way stopcock to fill the manometer to the top.
2. Turn the stopcock to connect the manometer to the
valve and SIPHONGUARD Device (Figure A-3).
3. Bring the end of the distal catheter level with the fluid
level in the manometer (Figure A-4).
Note: The device must lie on a sterile surface and
remain undisturbed for the duration of the test.
4. Hold the distal end of the catheter adjacent to the
manometer and slowly lower the end of the catheter
until the fluid level in the manometer begins to drop.
5. Continue to lower the end of the catheter at a
rate that exceeds the drop rate of the fluid level
in the manometer. As you do so, you will note a
corresponding increase in the rate of descent of the
fluid level in the manometer.
6. A point will be reached where the rate of descent
of the fluid level in the manometer dramatically
decreases, but does NOT stop. This is the point at
which the SIPHONGUARD Device primary pathway
closes and flow diverts to the higher resistance
secondary pathway. This confirms proper functioning
of the SIPHONGUARD Device.
7. Repeat Steps 3 through 6 as necessary to reconfirm
SIPHONGUARD Device function.
Manometer Testing
Note: Performing a manometer test is not recommended
as this test is susceptible to environmental factors and
yields a result that is not physiologic in nature and for
which manufacturers do not specify performance ranges.
Equipment Required (use all sterile equipment, perform
testing under sterile conditions)
One sterile manometer, wide-bore (e.g. 3.5 mm),
graduated in mm (available in lengths from 38 to 60 cm)
One sterile 4-way stopcock
One sterile syringe, 10mL minimum is recommended
One sterile syringe filter, 5 µm
Sterile tubing adapters
Sterile silicone tubing
One sterile male luer connector with 1/16 in. (1.6 mm) barb
Sterile saline solution
Sterile fluid reservoir or water bath