Integra CODMAN CERTAS Plus Bedienungsanleitung

EN – ENGLISH............................................2

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

THIS PAGE IS INTENTIONALLY LEFT BLANK.

EN – ENGLISH

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

Figure 1

Note:

C-F are stored

inside the

zipped case.

EN – ENGLISH

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.

CODMAN CERTAS

Tool Kit

(01)10381780521334

82-8859

1 cm

(10)XXXX

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

• 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.

EN – ENGLISH

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

EN – ENGLISH

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

EN – ENGLISH

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.

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.

EN – ENGLISH

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.

EN – ENGLISH

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.

• 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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