Certas® Plus Video Toolbox: Tips and Best Practices

According to the Hydrocephalus Association, approximately one million Americans live with some type of hydrocephalus, which disrupts the balance of cerebrospinal fluid (CSF) production and absorption, causing CSF to build up inside the brain.

Certas® Plus Programmable Valves are implantable devices that can be set to different performance settings for intraventricular pressure and drainage of CSF. These performance settings can be set preoperatively and can also be noninvasively changed post-implantation by using the Certas® Plus Tool Kits.

Intraventricular pressure is maintained at a constant level by the ball and cone valve seat design, which provide a precise fit for regulating the flow of CSF through the valve.

Siphonguard® anti-siphon 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).

Here are four important how-to videos for the Certas Plus Valves and Tool Kits:

Priming Certas Plus Without Siphonguard®

How to Adjust the Certas Plus Programmable Valve Using the Electronic Tool Kit

Priming Certas Plus With Siphonguard®

Getting Flow With Occlude, Pump, Release

Certas Plus Programmable Valve

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.

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.
• 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.
• Read MRI Information before performing an MRI procedure on a patient implanted with the valve.
• Do not interchange the CODMAN CERTAS Tool Kit (82‑8851) components with the CODMAN CERTAS Therapy Management System TMS (82‑8850) components.
• 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

• Use only the CODMAN CERTAS Tool Kit to adjust the setting of the CODMAN CERTAS and CODMAN CERTAS Plus Programmable Valves.
• Excessive swelling may make it difficult to determine and/or adjust the performance setting.
• See 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.
• 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.

CERTAS Plus Electronic Tool Kit

INDICATIONS

The CERTAS Plus Electronic Tool Kit allows the noninvasive 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.
• Carefully monitor the patient during the first 24 hours after adjusting the value 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 mmH20.
• 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.