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proGAV ® 2.0
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proGAV ® 2.0 - 1

BIBRAUN SHARING EXPERTISE proGAV• 2.0 IN TOUCH WITH YOU

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proGAV ® 2.0 - 3

adjustable valves ■t have existed for decades. the adjustment and testing of the valve setting is still a challenge for those involved (i). Valve adjustments are performed postoperatively in 45 % of the cases. In 19 - 44 % of the cases further pressure adjustments will follow during later treatment (1, 2). Every valve adjustment is a challenge, both for the patient and the treating hospital staff. Diagnosis and adjustments are often only possible after a radiological examination, which is both time-consuming and costly. In addition to the journey to the clinic, the patient has to wait for...

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proGAV ® 2.0 - 4

VALVE AND SOFT TOUCH TOOLS USER-FRIENDLY ADJUSTMENT & VERIFICATION With the help of the unique “Soft Touch” instruments, the proGAV ® 2.0 offers a high level of patient comfort with its tactile feedback. Pressing the valve surface lightly with your finger releases the “Active-Lock” mechanism and simultaneously sends a tactile feedback. MRI 3 TESLA CONDITIONAL The “Active-Lock” mechanism of the proGAV ® 2.0 prevents unintended valve adjustments by external magnetic fields up to 3 Tesla (3-5). Strainful follow-up examinations can thus be reduced for the

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proGAV ® 2.0 - 5

(3) Allin DM, Czosnyka ZH, Czosnyka M, Richards HK, Pickard JD. In vitro hydrodynamic properties of the Miethke proGAV hydrocephalus shunt. Cerebrospinal Fluid Res. 2006 Jun;3:9. (4) Miyake H. Shunt Devices for the Treatment of Adult Hydrocephalus: Recent Progress and Characteristics. Neurol Med Chir (Tokyo). 2016 May 15;56(5):274-83. GRAVITATIONAL TECHNOLOGY Miethke gravitational valves offer a high protection against overdrainage complications in hydrocephalus therapy (6-8). (5) Chari A, Czosnyka M, Richards HK, Pickard JD, Czosnyka ZH. Hydrocephalus shunt technology: 20 years of...

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proGAV ® 2.0 - 6

ADJUSTABLE UNIT GRAVITATIONAL UNIT

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proGAV ® 2.0 - 7

The proGAV ® 2.0 is a posture-dependent valve, meaning the opening pressure changes gradually to correspond with the patients body position. proGAV ® 2.0 allows for complete customization of the patient‘s needs a specific opening pressure when the patient is lying down and an opening pressure for when the patient is upright. The adjustment unit is adjustable in 1 cmH2O steps between 0 and 20 cmH2O. The gravitational unit is offered in different pressure levels. The functionality of proGAV ® 2.0 in different body positions is illustrated interactively in the Miethke App.

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proGAV ® 2.0 - 8

FUNCTIONALITY OF VALVE AND BODY POSITION Valve opening pressure (cmH2O) 40

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proGAV ® 2.0 - 9

SUPINE POSITION When the patient is in the supine position, only the adjustable unit is active and preset to 5 cmH2O*. The gravitational unit is not active in this body position. UPRIGHT POSITION In the upright position, the gravitational and adjustable unit work together. As the patient sits up, the tantalum ball (presented in green) is activated within the gravitational unit and due to its gravitational forces causes an increase in the valve opening pressure. In the example shown, a gravitational unit with 25 cmH2O has been selected. The total opening pressure therefore amounts to 30...

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proGAV ® 2.0 - 10

SOFT TOUCH INSTRUMENTS FOR VALVE ADJUSTMENT LOCALIZATION AND SETTING IDENTIFICATION The proGAV ® 2.0 Compass is used to localize the adjustable unit and identify current setting of the valve. The Compass should be aligned over the valve with the aid of the integrated template – Compass lid is open. After the adjustable unit has been localized with the finger, the proGAV ® 2.0 Compass is applied over the valve in the direction of flow (Fig. 1) The closed Compass indicates the opening pressure setting (Fig. 2

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proGAV ® 2.0 - 11

ADJUSTING THE VALVE The proGAV ® 2.0 Adjustment Tool allows for an opening pressure of the adjustable unit to be set from 0 to 20 cmH2O. The proGAV ® 2.0 Adjustment Tool should be positioned so that the desired opening pressure is reflected in the direction of the valve inlet connector. The proGAV ® 2.0 Adjustment Tool should be centered over the valve. By pressing lightly with the finger on the adjustable unit, the mechanical “Active-Lock” mechaniscm is deactivated and the opening pressure is set. Releasing the finger pressure automatically locks the valve (Fig. 3).

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proGAV ® 2.0 - 12

Selection of pressure levels Combined opening pressure Newborn and children up to 5 years All pressure levels shown here are in cmH2O. This is a non-binding recommendation. The physician decides in each case individually. to mobile patients. For patients with little mobility or a high BMI, the gravitational unit should be chosen lower than recommended here. OPENING PRESSURE RECOMMENDATION The choice of the appropriate pressure level of proGAV® 2.0 depends on several other factors, including age, degree of activity, size and stature of the patient. The values given apply

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proGAV ® 2.0 - 13

■ Combination of adjustable unit with gravitational unit * Recommendations should only be used as guideline as other settings may also be necessary depending on the patient and anatomy. Connector: d = 1.9 mm o Adjustable unit: do= 4.5 mm Gravitational unit: d = 4.2 mm o Art. No. Adjustable unit Gravitational unit Children up to 5 years old and adults over 65* FX643T 0 - 20 cmH2O 25 cmH2O Individuals between 5 and 65 years old* OPTIONAL CONFIGURATIONS Art. No. Adjustable unit Gravitational unit

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proGAV ® 2.0 - 14

■ Combination of adjustable unit and gravitational unit with an integrated distal catheter (1200 mm) * Recommendations should only be used as guideline as other settings may also be necessary depending on the patient and anatomy. Connector: d = 1.9 mm o Adjustable unit: do= 4.5 mm Gravitational unit: d = 4.2 mm o Catheter: d = 1.2 mm, d = 2.5 mm I ' o Art. No. Adjustable unit Gravitational unit Children up to 5 years old and adults over 65* FX649T 0 - 20 cmH2O 25 cmH2O Individuals between 5 and 65 years old* OPTIONAL CONFIGURATIONS Art. No. Adjustable unit Gravitational unit

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proGAV ® 2.0 - 15

proGAV® 2.0 SHUNT SYSTEM WITH SA 2.0 AND PEDIATRIC SPRUNG RESERVOIR • Combination of adjustable unit and gravitational unit with an integrated distal catheter (1200 mm) • Pediatric SPRUNG RESERVOIR** with an integrated distal catheter (200 mm) • Ventricular catheter with introducing stylet (180 mm) * Recommendations should only be used as guideline as other settings may also be necessary depending on the patient and anatomy. ** An additional valve in the base of the pediatric SPRUNG RESERVOIR makes it possible to flush the fluid only in the distal direction. This feature allows for...

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