CERTAS Plus Electronic Tool Kit Instructions

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EN – ENGLISH

CERTAS™ Plus Electronic Tool Kit 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 Note: F. Instructions for Use C-F are stored G. Quick Reference Card inside the zipped case.

Figure 1

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CERTAS™ Plus Electronic Tool Kit EN – ENGLISH . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3 SCH – 中文（简体） . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .21 DA – DANSK . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .39 NL – NEDERLANDS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .57 FI – SUOMI . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .75 FR – FRANÇAIS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .93 CODMAN CERTAS DE – DEUTSCH . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .111 Tool Kit IT – ITALIANO . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .129 NO – NORSK . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .147 PT (EU) – PORTUGUÊS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .165 RU – РУССКИЙ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .183 ES – ESPAÑOL . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .203 SV – SVENSKA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .221

1 cm 82-8859 (01)10381780521334 (10)XXXX

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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/Intended Purpose 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.

Performance Characteristics It is recommended that each adjustment of the valve setting be limited to an increase or decrease of one setting, since setting changes can range between 15 and 50 mmH2O.

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.

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EN – ENGLISH • 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 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). If it is used in a residential environment (for which CISPR 11 class B is normally required) this equipment might not offer adequate protection to radio-frequency communication services. The user might need to take mitigation measures, such as relocating or re-orienting the equipment.

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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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.

Purple button

Calibration Screen

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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.

System-ready screen

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.

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EN – ENGLISH 3. W  hen 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.

CAUTION: Failure to accurately orient the device with the valve direction of flow could result in an inaccurate indication of the valve setting. 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.

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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 attempting 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 setting.

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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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.

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. o Confirm that the Adjustment Tool is a minimum distance of 60 cm (24 in.) away from the Locator. o 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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EN – ENGLISH 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 battery reminder icon, the system has less than 4 minutes of power remaining before batteries need to be replaced. Replace the batteries using the screwdriver stored inside of the zipped packet of the tool kit.

Batteries and a screwdriver are stored in the case pocket.

If the display shows battery alert icon, the batteries must be replaced using the screwdriver stored inside of the zipped pocket of the tool kit.

Batteries can be replaced by using the screw placed under the purple button. Only replace with 123A batteries.

Case pocket

If the display shows system error icon, contact your local sales representative.

When left 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 button is pressed before the timer counts down to :00 seconds.

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EN – ENGLISH Figure 2 A

B

D C E

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 Setting The setting 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 setting. When viewing the x-ray film or screen to confirm the valve setting, use the X-Ray Overlay Tool.

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EN – ENGLISH Figure 3

The number in the lower left corner of each view indicates which Performance Setting is shown. White box indicates the setting indicator. Red circle indicates the right hand side (RHS) marker.

Reading the Valve Setting 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 settings are properly oriented for viewing. In this orientation, the righthand 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 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.

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EN – ENGLISH Figure 4 B

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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

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1 cm 82-8859 (01)10381780521334 (10)XXXX

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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.

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EN – ENGLISH 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 setting. 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. 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

Harmonic emissions IEC 61000-3-2

Not Applicable

Voltage fluctuations/ flicker emissions IEC 61000-3-3

Not Applicable

Emissions test

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.

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EN – ENGLISH 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

Electrostatic discharge (ESD) IEC 61000-4-2

Electrical fast transient/burst

IEC 60601 test level

Compliance level

Electromanetic environment – guidance Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30 %.

± 8 kV contact

± 8 kV contact

± 15 kV air

± 15 kV air

Not applicable

Not applicable

Not applicable

Not applicable

Not applicable

Not applicable

Not applicable

Not applicable

Not applicable

30 A/m

Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

IEC 61000-4-4 Surge IEC 61000-4-5 Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11

Power frequency (50/60 Hz) magnetic field

30 A/m

IEC 61000-4-8

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EN – ENGLISH 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 Compliance test level level

Electromanetic environment – guidance 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 transmitter. 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 Radiated RF IEC 61000-4-3

3 V/m 80 MHz to 2.7 GHz

3 V/m

where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey,a should 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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EN – ENGLISH a

F ield strengths from fixed transmitters, 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 transmitters, 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. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

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Table 4 Recommended separation distances between portable and mobile RF communications equipment and the Tool Kit Rated Separation distance according to frequency of transmitter m maximum output power of 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz transmitter d = 1.2 √ P d = 1.2 √ P d = 2.3 √ P W 0.01

0.12

0.12

0.23

0.1

0.38

0.38

0.73

1

1.2

1.2

2.3

10

3.8

3.8

7.3

100

12

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For transmitters 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 transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter 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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EN – ENGLISH Replacement The CERTAS Plus Electronic Tool Kit cannot be repaired. Contact your local sales representative for replacement. Product Lifetime Inspect the Tool Kit components before each use. Check for damage, such as cracks. Do not use the Tool Kit if damage is present. Do not use the Tool Kit if non-invasive reading or adjustment of the CERTAS and CERTAS Plus programmable valves setting can not be performed. 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. Any serious incident that has occurred in relation to the device for the user and/or the patient should be reported to the manufacturer and the competent authority of the member state in which the user and/or patient is established. 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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