Integra CODMAN CERTAS Plus User manual

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SCH – 中文（简体）.....................................20
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NL – NEDERLANDS .......................................56
FI – SUOMI...............................................74
FR – FRANÇAIS...........................................92
DE – DEUTSCH ...........................................110
IT – ITALIANO............................................128
NO – NORSK .............................................146
PT (EU) – PORTUGUÊS....................................164
RU – РУССКИЙ. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .182
ES – ESPAÑOL............................................202
SV – SVENSKA. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .220
82-8852
CERTAS™Plus
Electronic Tool Kit

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IMPORTANT INFORMATION
Please Read Before Use
Tool Kit Description
The CERTAS™ Plus Electronic Tool Kit (Tool Kit) is a battery-powered,
handheld device used to locate, indicate, adjust and confirm the performance
setting of all implantable CERTAS and CERTAS Plus Programmable Valves in
the treatment of hydrocephalus.
The Tool Kit contains (see Figure 1 for images of the CERTAS Plus Electronic
Tool Kit components):
A. Locator device including batteries
B. Adjustment tool
C. Screwdriver
D. Spare (123A) batteries
E. X-Ray Overlay Tool
F. Instructions for Use
G. Quick Reference Card
CERTAS™Plus
Electronic Tool Kit
A B
C
D
Figure 1
Note:
C-F are stored
inside the
zipped case.

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Valve Description
The CERTAS Plus Programmable Valve is a single-use implantable valve that
can be set to eight different performance settings for intraventricular pressure
and drainage of CSF. The Tool Kit is designed to indicate and adjust all CERTAS
and CERTAS Plus Programmable Valves.
Indications for Use
The CERTAS Plus Electronic Tool Kit allows the non-invasive reading
or adjustment of the valve setting for the CERTAS and CERTAS Plus
Programmable Valves.
Precautions
• The device should be used only in professional healthcare facility
environments.
• The device should not be used near high frequency surgical equipment,
in proximity to an MRI, or anywhere the intensity of electromagnetic
disturbances is high. If used in an environment other than specified,
degradation of the performance of this equipment could result, meaning
the device may not provide a stable indication or screen flickers may be
seen.
• Do not use any of the Tool Kit components on a metal surface, as this
could interfere with the use of the device.
• The Adjustment Tool contains powerful magnets and should be kept
away from magnetic materials.
• Store and carry all components of the Tool Kit in the storage case when
not in use to prevent damage.
• Inspect the 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 sales representative for a replacement kit.
E
2
CODMAN CERTAS
Tool Kit
AB
CD
F
E
(01)10381780521334
82-8859
1 cm
(10)XXXX
F
G
EN – ENGLISH ............................................2
SCH – 中文（简体） .....................................20
DA – DANSK. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .38
NL – NEDERLANDS .......................................56
FI – SUOMI ...............................................74
FR – FRANÇAIS ...........................................92
DE – DEUTSCH ...........................................110
IT – ITALIANO ............................................128
NO – NORSK .............................................146
PT (EU) – PORTUGUÊS ....................................164
RU – РУССКИЙ. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .182
ES – ESPAÑOL ............................................202
SV – SVENSKA. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .220
82-8852
CERTAS™ Plus
Electronic Tool Kit

EN – ENGLISH
4
• 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.
• The valve setting should be confirmed after an MR procedure.
• Excessive swelling may make it difficult to determine and/or adjust the
setting. If difficulty correctly positioning the Locator persists, wait until
the swelling is reduced. X-ray may be used to confirm the valve setting.
• Failure to accurately position the Locator 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
Locator). 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.
•The emissions characteristics of this equipment make it suitable for use
in industrial areas and hospitals (CISPR11 class A).
Adverse Events
Accumulation of biological matter within the valve can cause difficulties
adjusting the valve setting and impair the anti-reflux function.
Adjusting the valve to a performance setting that is lower than necessary can
lead to excessive CSF drainage, which can cause subdural hematomas and
slit-like ventricles.
Magnetic Resonance Imaging (MRI) Safety Information
MR Unsafe
The Tool Kit is considered “MR Unsafe” in accordance with
the American Society for Testing and Materials (ASTM)
Standard F2503-13.
CAUTION: Do not use the CERTAS Plus Electronic Tool Kit in the MR suite.
Disinfecting the CERTAS Plus Electronic Tool Kit
The CERTAS Plus Electronic Tool Kit is provided as a non-sterile product.
After use, wipe the surfaces of the Tool Kit components that touch the patient
with a 70% Isopropyl wipe. 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.
CAUTION: Do not sterilize the Tool Kit.

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Instructions for Use
Note: Additional training materials are available from your local sales
representative.
SECTION A: Preparation and Set-Up
Pre-implantation: Confirm and/or adjust the performance setting before
implanting the CERTAS Plus Programmable Valve. This procedure is performed
before the sterile inner package is opened. Place the valve’s sterile package on
a non-metallic surface so the clear portion of the package faces up. Complete
the procedure as described in SECTION B.
Post-implantation: The valve may be adjusted 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.
Position the patient for the indication and/or adjustment procedure prior to
turning on the device. Complete the procedure as described in SECTION B.
CAUTION: Excessive swelling or thick tissue may make it difficult to determine
and/or adjust the performance setting. If difficulty correctly positioning the
Locator persists, wait until the swelling is reduced. X-ray may be used to
confirm the valve setting.
SECTION B: System Start-up
1. Power on the Locator by pressing and holding the purple button on
the front of the device until the screen turns on. The CERTAS Plus logo
will appear followed by a calibration screen. Make sure the Adjustment
tool is at least 60 cm (24 in.) from the Locator to avoid influencing the
calibration.
Calibration Screen
Purple buon

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Note: If the Adjustment Tool is within
the Adjustment Tool Cavity of the
Locator, the screen will alert the
user to remove the Adjustment Tool.
Calibration cannot be completed until
the Adjustment Tool is removed from
the device.
2. Press and release the purple button on the front of the device again to
complete calibration. After calibrating, the device is ready for use and
the system-ready screen will be shown.
SECTION C: Indication / Adjustment Procedure
1. Locate the valve and determine the general direction of flow.
Pre-Implantation: If in the package, ensure the direction of flow arrow
on the package and Locator are aligned (Figure 2).
Post-Implantation: For a valve implanted in a patient, locate and
determine the direction of flow of the valve by palpation, focusing
on the hard valve mechanism and inlet and/or outlet connections
(barbs/catheters).
2. Place the Locator on top of the blister or in contact with the patient,
oriented with the valve’s direction of flow. A valve illustration is inside
the Adjustment Tool cavity to serve as a reference for the valve.
(Figure 2)
Note: During post-implantation,
for best procedural results and
increased stability, grip the device
around its base and place the
concave portion of the Locator
perpendicular to the valve,
maximizing contact between
hand and patient. This will help to
maintain the appropriate position
above the valve mechanism.
System-ready screen

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CAUTION: Failure to accurately orient the device with the valve direction of
flow could result in an inaccurate indication of the valve seing.
Concave Section of the device base
4. Once the device is centered, the locating dot will illuminate white with
a checkmark and an indication dial window will appear. A single fully
visible number within the window indicates the current setting of the
valve.
4
3
3
3. When in proximity of the valve (within 2 cm or 0.8 in), the device will
display a locating dot. To center the device over the valve mechanism,
move the device to align the locating dot into the circle within the
valve. Move the device in a linear direction parallel to the valve, with
the concave section of the device base in contact with the patient. It is
important to maintain proper orientation with direction of flow.
Note: Tilting the Locator may result in challenges locating, indicating,
and adjusting the valve.

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Note: If a single number is not fully visible, then the Locator is not accurately
oriented with the valve. Remove the Locator and re-determine the valve’s
direction of flow before aempting to indicate again.
CAUTION: Do not rotate the Locator to obtain or center a number in the
window as this can result in an inaccurate indication of the performance
seing.
Do not rotate icon
5. Insert the Adjustment Tool into the Locator so that the line on the
Adjustment Tool is pointing towards the current setting. When the
Adjustment Tool is placed in the Locator, the device will not display
Location or Indication information.
Note: Failure to maintain accurate position (i.e., location and
orientation) could result in an inability to correctly adjust the setting.
6. Stabilize the Locator on the patient and turn the Adjustment Tool
directly to the desired performance setting. 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 to prevent inadvertent adjustment between
the extremes of available settings.
7. Maintain stability of the Locator on the patient and withdraw the
Adjustment Tool in a straight, upward motion. Keep the Adjustment
Tool a minimum distance of 60 cm (24 in.) from the Locator.
8. The Locator will begin to indicate the new valve setting once the
Adjustment Tool is removed. Always confirm the desired setting has
been achieved after adjustment.
• If the device does not provide an indication (or processing icon
persists), repeat steps 2 and 4 to confirm successful adjustment of
the performance setting.
• If the desired setting of the valve is not achieved, repeat the full
procedure.

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Note: Check mark is not required to indicate. The performance setting
may still be indicated as long as the device is in proximity of the valve and
accurately oriented with the valve’s direction of flow.
CAUTION: Failure to move the Adjustment Tool at least 60 cm (24 in) away
from the Locator can result in challenges locating, indicating, and adjusting
the valve.
9. Once the desired performance setting has been achieved, power down
the Locator by pressing and holding the purple button on the front of
the device until the screen turns off.
Disinfect the tool kit components (see Disinfecting the CERTAS Plus Electronic
Tool Kit section).
It is recommended to record the valve setting in the patient’s record and
Patient I.D. Card (available from your local sales representative).
Return both tools to their proper locations in the storage case.
Troubleshooting
If there is difficulty in indicating and/or adjusting the valve setting:
• If the display shows an indication between two settings and the Locator
is centered and oriented, remove the device from the patient and repeat
steps 1 and 2 of Section B. If the indication between settings persists and
the Locator is centered and oriented, insert the Adjustment Tool at the
desired setting and remove without rotating to a new setting.
3
• If there is difficulty receiving a valve indication, repeat calibration with
the Locator a minimum of 10 cm (4 in) above the valve while keeping it
aligned and parallel to the valve.
Confirm that the Adjustment Tool is a minimum distance of 60 cm
(24 in.) away from the Locator.
Confirm that the Locator is not tilted forward by ensuring that
the concave section of the device base is fully in contact with the
patient.
• If difficulties persist, use fluoroscopy or x-ray to determine orientation
of the valve 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 above the
implanted valve. Palpate to feel for the hard valve mechanism and make
sure the Locator is aligned with the valve’s direction of flow.

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If the display shows >10 mm, it means the
bottom of the device is >10 mm away from
the valve but it can provide valve location If
the device is not providing indication after
multiple attempts, take fluoroscopy or x-ray.
Additional Locator Icons
If the display shows
low baery reminder
icon, the system has
less than 4 minutes
of power remaining
before baeries need
to be replaced. Replace
the baeries using
the screwdriver stored
inside of the zipped
packet of the tool kit.
Baeries and a screwdriver are
stored in the case pocket.
Case pocket
If the display shows
baery alert icon,
the baeries must be
replaced using the
screwdriver stored
inside of the zipped
pocket of the tool kit.
Baeries can be replaced by
using the screw placed under the
purple buon.
Only replace with 123A baeries.
If the display shows system error icon, contact your local
sales representative.
When le idle for a prolonged period, the system will show
an auto shutdown alert and countdown timer. The system
will automatically shut down unless the front buon is
pressed before the timer counts down to :00 seconds.

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A. Valve (inside sterile package)
B. Arrows molded into plastic package
C. Locator (top view)
D. Valve Image with direction of the flow
E. Locator’s Valve Image on valve in the package
Confirming the Current Valve Seing
The seing of an implanted valve can be determined by using the Tool Kit, and
following SECTIONS A & B, followed by either SECTION C or D.
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 3 below for
x-ray views of the valve at each seing.
When viewing the x-ray film or screen to confirm the valve seing, use the
X-Ray Overlay Tool.
Figure 2
B
D
E
A
C

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Figure 3
The number in the lower le corner of each view indicates which Performance
Seing is shown. White box indicates the seing indicator. Red circle indicates
the right hand side (RHS) marker.
Reading the Valve Seing with the X-Ray Overlay Tool
Note: Position the X-Ray Overlay Tool flush against the x-ray image.
1. Align RED center line of valve on overlay with the center line of the valve
x-ray under review. This can be accomplished by aligning the proximal
and/or distal connectors of the x-ray image with those on the overlay.
2. Ensure that the numbers on the overlay that depict the performance
seings are properly oriented for viewing. In this orientation, the right-
hand side (RHS) marker red line extends to the right of the RED center
line. 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.
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 seing 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.

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B
D
A
E
G
C
F
E
F
(01)10381780521334
82-8859
1 cm
(10)XXXX
(01)10381780521334
82-8859
1 cm
(10)XXXX
B
D
A
E
G
C
F
E
F
(01)10381780521334
82-8859
1 cm
(10)XXXX
(01)10381780521334
82-8859
1 cm
(10)XXXX
A. Proximal connector
B. RED center line of valve
C. Right hand side (RHS) marker
D. RHS marker red line
(contains RHS dot)
E. Rotating construct (RC)
F. Magnet with tentalum ball
G. Distal connector
Environmental Specifications
Operating Temperature Range +10 °C to +30 °C
Operating Humidity Range 30% to 80% relative
humidity, non-condensing
Operating Pressure Range 70 kPa to 101.3 kPa
Transport & Storage Temperature Range –30 °C to +60 °C
Transport & Storage Humidity Range 15% to 85% relative
humidity, non-condensing
Transport & Storage Pressure Range 60 kPa to 101.3 kPa
Electromagnetic Compatibility
Medical electrical equipment requires special precautions regarding
electromagnetic compatibility (EMC) and needs to be installed and put into
service according to the EMC information provided in this document.
Figure 4

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The essential performance of the electronic Locator device is to locate the
CERTAS Plus programmable valve mechanism and display an indication dial
for the determination of valve performance seing.
WARNING: Portable RF communications equipment (including peripherals
such as antenna cables and external antennas) should be used no closer than
30 cm (12 inches) to any part of the locator device. Otherwise, degradation of
the essential performance of this equipment could result, meaning the device
may not provide a stable indication or screen flickers may be seen.
WARNING: Use of this equipment adjacent to or stacked with other
equipment should be avoided because it could result in improper operation.
If such use is necessary, this device and the other equipment should be
observed to verify that they are operating normally.
Table 1
Guidance and manufacturer’s declaration
- electromagnetic emissions
The CERTAS Plus Electronic Tool Kit is intended for use in the
electromagnetic environment specified below. The customer or the user
of the Tool Kit should ensure that it is used in such an environment.
Emissions test Compliance Electromagnetic
environment – guidance
RF emissions
CISPR 11 Group 1
The Locator uses RF energy only for
its internal function. Therefore, its
RF emissions are very low and are
not likely to cause any interference
in nearby electronic equipment.
RF emissions
CISPR 11 Class A
The Locator is suitable for use in all
establishments other than domestic
and those directly connected to the
public low-voltage power supply
network that supplies buildings
used for domestic purposes.
Harmonic
emissions
IEC 61000-3-2
Not
Applicable
Voltage
fluctuations/
flicker emissions
IEC 61000-3-3
Not
Applicable

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Table 2
Guidance and manufacturer’s declaration
– electromagnetic immunity
The CERTAS Plus Electronic Tool Kit is intended for use in the
electromagnetic environment specified below. The customer or the user
of the Tool Kit should ensure that it is used in such an environment.
IMMUNITY test IEC 60601
test level Compliance level
Electromanetic
environment –
guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
± 8 kV contact
± 15 kV air
± 8 kV contact
± 15 kV air
Floors should be
wood, concrete
or ceramic tile. If
floors are covered
with synthetic
material, the
relative humidity
should be at least
30 %.
Electrical fast
transient/burst
IEC 61000-4-4
Not applicable Not applicable Not applicable
Surge
IEC 61000-4-5
Not applicable Not applicable Not applicable
Voltage dips, short
interruptions and
voltage variations
on power supply
input lines
IEC 61000-4-11
Not applicable Not applicable Not applicable
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
30 A/m 30 A/m
Power frequency
magnetic fields
should be at levels
characteristic of a
typical location in a
typical commercial
or hospital
environment.

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Table 3
Guidance and manufacturer’s declaration
– electromagnetic immunity
The CERTAS Plus Electronic Tool Kit is intended for use in the
electromagnetic environment specified below. The customer or the user
of the Tool Kit should ensure that it is used in such an environment.
IMMUNITY test IEC 60601
test level
Compliance
level
Electromanetic
environment – guidance
Radiated RF
IEC 61000-4-3
3 V/m
80 MHz to
2.7 GHz
3 V/m
Portable and mobile RF
communications equipment
should be used no closer to
any part of the Tool Kit than
the recommended separation
distance calculated from the
equation applicable to the
frequency of the transmier.
Recommended separation
distance
d = 1.2 √ P 150 kHz to 80 MHz
d = 1.2 √ P 80 MHz to 800 MHz
d = 2.3 √ P 800 MHz to 2.5 GHz
where P is the maximum output
power rating of the transmier
in was (W) according to the
transmier manufacturer and d
is the recommended separation
distance in meters (m).
Field strengths from fixed RF
transmiers, as determined
by an electromagnetic site
survey,ashould be less than
the compliance level in each
frequency range.b
Interference may occur in the
vicinity of equipment marked
with the following symbol:
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic
propagation is affected by absorption and reflection from structures,
objects and people.

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aField strengths from fixed transmiers, such as base stations for radio
(cellular/cordless) telephones and land mobile radios, amateur radio,
AM and FM radio broadcast and TV broadcast cannot be predicted
theoretically with accuracy. To assess the electromagnetic environment
due to fixed RF transmiers, an electromagnetic site survey should be
considered. If the measured field strength in the location in which the
Locator device is used exceeds the applicable RF compliance level above,
the Locator devices should be observed to verify normal operation.
If abnormal performance is observed, additional measures may be
necessary, such as re-orienting or relocating the Tool Kit.
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be
less than 3 V/m.
Table 4
Recommended separation distances between portable and
mobile RF communications equipment and the Tool Kit
Rated
maximum
output
power of
transmier
W
Separation distance according to frequency of transmier m
150 kHz to 80 MHz
d = 1.2 √ P
80 MHz to 800 MHz
d = 1.2 √ P
800 MHz to 2.5 GHz
d = 2.3 √ P
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73
11.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
For transmiers rated at a maximum output power not listed above, the
recommended separation distance d in meters (m) can be estimated using
the equation applicable to the frequency of the transmier, where P is the
maximum output power rating of the transmier in was (W) according to
the transmier manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher
frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic
propagation is affected by absorption and reflection from structures,
objects and people.

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Replacement
The CERTAS Plus Electronic Tool Kit cannot be repaired. Contact
your local sales representative for replacement.
Product End of Life
The CERTAS Plus Electronic Tool Kit has an expected use life of five
years. The Tool Kit contains electrical components and should be
disposed of in accordance with local ordinances at end of life.
Warranty
Integra LifeSciences Corporation 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.

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