proGAV Tools Instructions For Use Feb 2017

INSTRUCTIONS FOR USE |

USA

CONTENT INDICATION4 proGAV VERIFICATION TOOL4 proGAV MASTERDISC4 proGAV VERIFICATION COMPASS4 proGAV ADJUSTMENT TOOL5 proGAV ADJUSTMENT DISC5 proGAV CHECK-MATE6 CLEANING AND DISINFECTING THE proGAV CHECK-MATE6 RECOMMENDATION FOR STERILISATION OF THE proGAV CHECK-MATE 

8

RECOMMENDATION FOR STERILISATION

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CLEANING RECOMMENDATION FOR proGAV 8 INSTRUMENTS WHICH ARE NOT STERILISABLE

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TECHNICAL DESCRIPTION

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FUNCTION OF THE proGAV11 PHYSICS BACKGROUND

12

SELECTING THE APPROPRIATE PROGAV

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ADJUSTING THE proGAV14 READING THE PRESSURE SETTING FROM AN X-RAY IMAGE

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MEDICAL PRODUCTS CONSULTANT

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GENERAL INFORMATION

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RECOMMENDATION OF PRESSURE LEVELS 

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VARIANTS18

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| INSTRUCTIONS FOR USE

INSTRUCTIONS FOR USE |

the brake is decoupled, the rotor turns and the adjusted pressure is achieved. The marking (5) on the proGAV ADJUSTMENT TOOL has to point towards the proximal catheter (leading to the ventricle).

CAUTION Federal law restricts this device to sale by or on the order of a physician! INDICATION The Miethke proGAV Programmable Shunt System is intended to shunt cerebrospinal fluid (CSF) from the lateral ventricles of the brain into the peritoneum. Caution: Do not use the proGAV Tools nearby pacemakers due to magnets inside the proGAV Tools. Note: These Tools contain material which has been determined to be MR Unsafe. DO NOT use in or around strong magnetic fields such as MR imaging equipment.

proGAV VERIFICATION TOOL The proGAV VERIFICATION TOOL is used for reading the valve opening pressure setting. First, the proGAV VERIFICATION TOOL should be placed on the valve. The marking (3) on the proGAV VERIFICATION TOOL must be in line with the proximal (ventricular) catheter. The tool contains two magnets. As soon as the button on the instrument is pushed (2) the magnets in the tool align with the magnets in the valve. The opening pressure is shown on the scale (1). 2

Fig. 3: proGAV VERIFICATION COMPASS Fig. 1: proGAV VERIFICATION TOOL

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4

Caution: X-ray confirmation may still be necessary for patients with scalp thicknesses greater than or equal to 5 mm thick.

proGAV MASTERDISC The proGAV VERIFICATION TOOL can be easily checked by using the proGAV MASTERDISC before measuring the opening pressure of the valve. On the disc the positions 0, 5, 10, 15 and 20 cmH2O are indicated. If the proGAV VERIFICATION TOOL is placed on the disc the opening pressure shown by the instrument should be aligned to the value of the proGAV MASTERDISC. Example: The proGAV VERIFICATION TOOL is put on the proGAV MASTERDISC so that the marking on the instrument is in line with the value 10 cmH2O on the proGAV MASTERDISC. The proGAV VERIFICATION TOOL should indicate the value of 10 cmH2O.

The following table shows the quantitative information regarding the overall agreement rates between the X-ray and the respective verification tool for the proGAV valve. The maximum deviation from the actual valve readings used were 0, ≤ 1, ≤ 2, > 2 cmH2O. For example at ≤ 2 cmH2O 99.1% of the measurements made by the proGAV VERIFICATION TOOL with the proGAV valve deviate not more than ± 2 cmH2O from the actual value of the valve. The agreement rates are based on non-clinical testing with readings of 15 valves by 15 clinical users under simulated use conditions, yielding a total of 225 readings with each valve and verification tool or compass. =0 cmH2O

≤1 cmH2O

≤2 cmH2O

>2 cmH2O

proGAV VERIFICATION TOOL proGAV Valve Fig. 2: proGAV MASTERDISC

PROGAV VERIFICATION COMPASS

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Alongside the proGAV VERIFICATION COMPASS there is an additional device for measuring the adjusted opening pressure. The compass can be used to locate the valve when palpation is not possible. The measuring compass is set on the skin over the implanted valve and moved in a circling motion until the internal disc is fixed over the valve. The opening pressure corresponds to the value indicated towards the direction of the ventricular catheter.

33.3 %

93.8 %

99.1 %

47.6 %

97.3 %

99.1 %

3

1 2

0.9 %

proGAV VERIFICATION COMPASS proGAV Valve

Warning note: If the implantation site is poorly selected or if the skin over the valve is too thick, adjustment of the proGAV can be difficult or sometimes impossible. The valve works then as gravitational valve with constant opening pressure. The patient should be informed about the risk.

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Fig. 4: proGAV ADJUSTMENT TOOL

0.9 %

proGAV ADJUSTMENT TOOL The proGAV ADJUSTMENT TOOL is used for adjusting the valve opening pressure. First the intended pressure setting is selected at the knurled dial (1), the opening pressure is shown on a scale (2). Then the proGAV ADJUSTMENT TOOL is placed central on the valve. By pushing the button (3), the adjustment tip (4) appears,

proGAV ADJUSTMENT DISC The proGAV ADJUSTMENT DISC offers an other option to adjust the pressure setting. The proGAV ADJUSTMENT DISC is placed centrally over the valve. The desired pressure setting should be aligned with the proximal catheter (leading to the ventricle). By pressing down the proGAV ADJUSTMENT DISC on the valve, the brake is decoupled and the opening pressure of the proGAV is changed.

Note: Airbubbles inside the COMPASS do not affect its functionality! 5

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| INSTRUCTIONS FOR USE

proGAV CHECK-MATE ( ) 0297

The proGAV CHECK-MATE is intended to be re-sterilised. It is possible to change and to verify an applied pressure setting on the valve directly. To verify the actual pressure setting the proGAV CHECK-MATE has to be put centrally over the valve. The proGAV CHECK-MATE will immediately start to move, if it can move freely. If it remains stable, the pressure setting can be read in allignment to the inlet connector. To adjust a new pressure setting, the proGAV CHECK-MATE has to be placed centrally over the valve. The new pressure setting has to point in direction to the inlet connector (leading to the ventricle). By pressing down slightly the proGAV CHECK-MATE, the brake of the valve is decoupled, the rotor turns and the opening pressure of the proGAV is changed. Please be aware that the steps for changing the pressure setting should not be more than 8 cmH2O per step (see page 30).

CLEANING AND DISINFECTING THE proGAV CHECK-MATE

INSTRUCTIONS FOR USE |

Avoid damage to the product due to inappropriate cleaning/disinfecting agents and/or exessive temperatures! • Use cleaning and disinfecting agents approved for surgical steels according to the manufacturer‘s instructions. • Observe specifications regarding concentration, temperature and exposure time. • Do not exceed the maximum allowable cleaning temperature of 55°C. • Carry out ultrasound cleaning: - as an effective mechanical supplement to manual cleaning/disinfecting. - as a pre-cleaning procedure for products with encrusted residues, in preparation for mechanical cleaning/disinfecting. - as an integrated mechanical support measure for mechanical cleaning/disinfecting. - for additional cleaning for products with residues left after mechanical cleaning/disinfecting. • Clean and disinfect instruments mechanically, provided they can be securely fixed in machines or storage devices in such a way that they will be thoroughly cleaned. Manual cleaning/disinfecting • Check visible surfaces for residues after manual cleaning/disinfecting. • Repeat the cleaning process if neccessary. Mechanical cleaning/disinfecting • Place the product on a tray that is suitable for cleaning (avoid rinsing blind spots). Mechanical cleaning/disinfecting with manual pre-cleaning Manual pre-cleaning with ultrasound

Stage

Step

T (°C/°F)

t (min)

Conc. (%)

Water quality

Chemical

I

Desinfecting ultrasound cleaning

RT (cold)

15

2

D-W

BBraun Stabimed; aldehyde phenol and QAV free; pH = 9

II

Intermediate rinse

RT (cold)

1

-

D-W

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D-W: Drinking water, RT: Room temperature Mechanical alkaline cleaning and thermal disinfecting

Machine type: Single-chamber cleaning/disinfecting machine without ultrasound • Place the product on a tray that is suitable for cleaning ( avoid rinsing blind spots)

Stage I • Clean the product in an ultrasound cleaning bath (frequency 35 kHz). Make certain that all accessible surfaces are moistened.

Stage II • Rinse the product completely (all accessible surfaces) under running water.

Stage

Step

T (°C/°F)

t (min)

Water quality

Chemical

I

Prerinse

<25/77

3

D-W

-

II

Cleaning

55/131

10

FD-W

-Concentrate, alkaline: pH = 10.9 <5% anionic tensides -1% solution: pH = 10.5

III

Neutralization

20/68

2

FD-W

- Concentrate, acid: pH = 2,6 Basis: Citric acid - 1% solution: pH = 3,0

IV

Intermediate rinse

70/158

1

FD-W

-

V

Thermal disinfecting

94/201

10

FD-W

-

VI

Drying

90/194

40

-

-

Fig. 6: proGAV CHECK-MATE

D-W: Drinking water, FD-W: Fully desalinated water (demineralized)

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| INSTRUCTIONS FOR USE

INSTRUCTIONS FOR USE |

Control, care and inspection • Allow the product to cool down to room temperature. • Inspect the product after each cleaning and disinfecting cycle to be sure it is clean, functioning properly, not damaged, has intact insulation and does not have any loose, bent, broken, cracked, worn, or fractured components. • Set aside the product if it is damaged.

RECOMMENDATION FOR STERILISATION

We recommend putting the instrument in a double sterile bag after cleaning. So the next use in the theatre (sterile area) will be prepared as its best.

Attention: proGAV instruments are made from thermal unstable components which are affectable by heat or humidity or chemical agressive substances. Do not steep the proGAV instrument in liquids and keep the inside of the instruments dry!

RECOMMENDATION FOR STERILISATION OF THE proGAV CHECK-MATE The proGAV CHECK-MATE should be sterilised by steam sterlization (fractionated vacuum process) at 132°C and 4 minutes cycle time.

Sterilization for proGAV CHECK-MATE in the USA

Except for the proGAV CHECK MATE, proGAV instruments can not be sterilised.

CLEANING RECOMMENDATION FOR PROGAV INSTRUMENTS WHICH ARE NOT STERILISABLE

Remove surface pollution of the proGAV instruments after the use immediately with alcohol based cleaners (more than 75% alc.) by a wiping procedure. The time of impact should be more than 60 sec. and should be depending on the level of pollution. For final cleaning use a dry wipe.

TECHNICAL DESCRIPTION OF THE proGAV The proGAV is a posture dependent hydrocephalus valve. It comprises a ball-cone valve with adjustable opening pressure and a fixed pressure gravitational unit. In this way, optimal CSF drainage is ensured for each individual patient in any body position. The function of both units is described as follows. Fig. 8 shows a schematic cross section of the proGAV. The adjustable unit is composed of a solid titanium body with a well-tried ballcone valve (1) integrated in its proximal part. A

bow spring (2) defines the opening pressure of the ball-cone valve. The pretensioning of the spring, and thus the valve opening pressure, can be adjusted by turning a rotor (3), with the valve implanted under the patient’s skin. The gravitational unit contains a tantalum ball (4), which defines the opening pressure of this valve, and a sapphire ball (5), which ensures the precise closure of the valve. A connector under the silicone catheter (6) always allows a later disconnection of the catheter if necessary. CAUTION Federal law restricts this device to sale by or on order of a physician!

Fig. 7: The proGAV is a combination of an adjustable unit and a gravitational unit.

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Adjustable unit

Validated Cycle: Sterilizer Type:

Prevacuum

Minimum Temperature:

132 degrees Celsius

Full Cycle Time:

4 minutes

Minimum Dry Time:

20 minutes

Sample Configuration:

Sterilization Container (Aesculap SterilContainer)

USA

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The following cleaning methods are not allowed for the cleaning of the proGAV instruments (except CHECK-MATE): Irradiation, Ultrasonic, Sterilization, Machine preparation, Inserting into liquids.

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6

Gravitational unit

4 5

CFU should be determined and lower than 10CFU per item

1 sapphire ball 2 torsion bar 3 rotor 4 tantalum ball 5 sapphire ball 6 connector under the silicone catheter

Fig. 8: Schematic cross section of the proGAV

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| INSTRUCTIONS FOR USE

Function of the proGAV The opening pressure of the proGAV is composed of the opening pressure of the adjustable unit and the opening pressure of the gravitational unit.

INSTRUCTIONS FOR USE |

Vertical position As soon as the patient moves into an upright position, the gravitational unit closes, the opening pressure of the proGAV is significantly increased and CSF drainage is blocked (fig. 10a). Only when the sum of the IVP and the hydrostatic pressure exceeds the opening pressure of the proGAV, drainage will be possible again (fig. 11b). The opening pressure of the proGAV in the vertical position is the sum of the opening pressures of both the adjustable unit and the gravitational unit (weight of the tantalum ball).

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PHYSICS BACKGROUND The intraventricular pressure is positive in a healthy human in a horizontal position. To adjust this pressure through shunt drainage, one has to choose the appropriate pressure range, taking into account the abdominal cavity pressure. The resulting IVP is the sum of the shunt opening pressure and the abdominal cavity pressure (fig. 12).

The ventricular pressure in a healthy human in a vertical position becomes slightly negative. To maintain this pressure by means of shunt drainage, the shunt opening pressure has to be significantly higher so that the shunt can compensate the hydrostatic pressure minus the sum of the abdominal cavity pressure and the slightly negative intraventricular pressure.

Fig. 9: Gravitational unit in horizontal position

IVP PVli Horizontal posture When the patient is lying down, the gravitational unit is always open and therefore does not present any resistance to the fluid flow. Hence, the opening pressure of the proGAV is defined by the adjustable unit. The operational principle of the adjustable unit is illustrated in figures 10a and b. In fig. 10a, the ball-cone valve is closed. The drainage is blocked. In fig. 10b, the adjustable unit is shown in the open condition. The patient’s IVP is increased and the spring force, which otherwise keeps closed the ball-cone valve, is overcome. The closing ball moves out of the cone and a gap opens to allow drainage.

Intraventricular pressure Opening pressure in horizontal position (adjustable unit only) Opening pressure in vertical position (adjustable + gravitational unit) Pressure in the abdominal cavity Hydrostatic pressure

PVst PB PHyd

proGAV

0...20

CHRISTOPH MIETHKE

PHyd

horizontal: IVP = PVli + PB standing: IVP = PHyd - PVst - PB

a)

PVst

PVli

b)

Fig. 11: Gravitational unit in upright

IVP

IVP

position a) closed, b) open

0...20

proGAV

PB

CHRISTOPH MIETHKE

PB

Fig. 12: Pressure situation at the shunt for horizontal and vertical position

a)

b) Fig. 10: Adjustable unit a) closed b) open

10

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| INSTRUCTIONS FOR USE

SELECTING THE APPROPRIATE proGAV The proGAV is a position-dependent shunt, meaning the opening pressure changes depending on the position of the patient.

INSTRUCTIONS FOR USE |

The following opening pressure ranges for the gravitation unit are possible, the pressure range selected can be checked postoperatively on Xray image:

ADJUSTING THE proGAV Each proGAV is calibrated under strict quality control procedures. The presetting of the adjustable unit is 5cmH2O, but it must be checked before implantation. The setting is changed in the following steps:

USA

Caution: Placing the proGAV VERIFICATION TOOL in a non-central position on the valve can lead to erroneous readings!

3. The proGAV ADJUSTMENT TOOL is set to the required opening pressure by turning the knurled dial of the unit (fig. 16).

To choose the proGAV for an individual patient, one opening pressure is set for the horizontal position (patient lying down), and one for the vertical position (patient standing upright).

Opening pressure for vertical posture

Coding of gravitational unit

10 cmH2O

small, no ring

Horizontal position: The opening pressure for the horizontal position is defined by the adjustable unit. The pressure level should be choosen according to the clinical situation and indication. The unit can be adjusted to a pressure setting between 0 cmH2O and 20 cmH2O.

15 cmH2O

large, no ring

20 cmH2O

large, 1 ring

25 cmH2O

large, 2 rings

TOOL

30 cmH2O

large, 3 rings

Vertical position: The opening pressure of the proGAV for the vertical position is calculated by the sum of the opening pressure of the adjustment and of the gravitational unit. The selection of the gravitational unit depends on the activity and the abdominal pressure (adiposity).

35 cmH2O

large, 4 rings

Caution: The new opening pressure setting of the valve must not differ from the measured opening pressure by more than 8 cmH2O in any one setting (see page 30).

1. The valve is located under the skin (fig. 14).

Abb. 16: Adjustment of the proGAV VERIFICATION

Fig. 14: Locating the valve

2. The proGAV VERIFICATION TOOL is positioned centrally on the valve. The marking on the instrument has to point towards the proximal catheter (leading to the ventricle). The button is pushed and the pressure setting is read (fig. 15).

Coding ring

a)

b)

Fig. 13: X-ray image of the gravitational unit a) large, 1 ring = 20 cmH2O, b) small = 10 cmH2O

a)

4. The proGAV ADJUSTMENT TOOL is positioned centrally on the valve. The marking on the instrument has to point towards the proximal catheter (leading to the ventricle).

5. As soon as the proGAV ADJUSTMENT TOOL has been positioned centrally on the valve, the button is pushed onto the valve and the adjustment tip appears. This triggers the mechanical decoupling and the valve setting is adjusted to the required opening pressure setting (fig. 17). Caution: By pushing the button the instrument should stay very close to the valve.

p ro G A V

0...20

CHRISTOPH MIETHKE

b) Fig. 15: Measuring the pressure setting a) correctly, b) incorrectly

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| INSTRUCTIONS FOR USE

INSTRUCTIONS FOR USE |

re the rotor would turn in a counter clockwise direction (short way) and would stop at the position 0 cmH2O (fig. 18a). The correct adjustment is in 2 steps: Adjustment from 3 to 11, and from 11 to 18 cmH2O. The rotor turns now in a clockwise direction (fig. 18b).

READING THE PRESSURE SETTING FROM AN X-RAY IMAGE

3

3 0

11

18 a)

b)

Fig. 18: Rotor rotation during adjustment a)

b)

Fig. 17: Adjusting the pressure setting

6. After the adjustment, the valve opening pressure is measured again, as described in step 2. If the pressure measured now differs from the intended pressure level, the adjustment procedure has to be repeated from step 3. After adjusting the proGAV using the proGAV ADJUSTMENT TOOL, it can be verified using the proGAV VERIFICATION TOOL and may be confirmed by radiograph (X-ray). Caution: Due to postoperative swelling of the skin the adjustment of the valve setting may be difficult within the first few days. During the adjustment the opening pressure of the adjustable unit should not be changed more than 8 cmH2O per adjustment procedure. Example: Opening pressure is to be changed from 3 to 18 cmH2O. With only one adjustment procedu14

a) false b) correct

The pressure setting of the proGAV should be measured with the proGAV VERIFICATION TOOL, but if there is any discrepancy between the desired adjustment setting and the setting that is read by the proGAV VERIFICATION TOOL, then a radiographic confirmation (x-ray) can be performed to confirm the actual valve setting. The magnets are visible in the image as white dots. The direction of the rotor tip indicates the pressure setting. The rotor tip can take any position outside region (Fig. 19). Thus, the opening pressure of the proGAV can be adjusted in increments of 1 cmH2O between 0 and 20 cmH2O. In order to avoid misidentification of the adjusted opening pressure in the X-ray image, the valve is flattened on one side.

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7

MEDICAL PRODUCTS CONSULTANT In compliance with the requirements of the European law MDD 93/42/EEC, Christoph Miethke GmbH&Co. KG names medical pro­ duct consultants as the individuals to be addressed with all queries concerning the products: Dipl.-Ing. Christoph Miethke Dipl.-Ing. Roland Schulz Christoph Miethke GmbH & Co. KG Ulanenweg 2 D-14469 Potsdam Phone: +49(0) 7000 6438453 or Phone: +49(0) 331 620 83 0 Fax: +49(0) 331 620 83 40 e-mail: [email protected]

USA

GENERAL INFORMATION

Manufacturer

Christoph Miethke GmbH & Co. KG

Product name

TOOLS for proGAV

Intended use

Treatment of Hydrocephalus

Store in a clean, dry place

Please address any enquiries to: AESCULAP AG Am Aesculap Platz D-78532 Tuttlingen Phone: +49 (0) 7461 95-9 Fax: +49 (0) 7461 95-26 00 e-mail: [email protected] Service address in the US AESCULAP Inc. Attn. AESCULAP Technical Services 615 Lambert Pointe Road Hazelwood, MO, 63042 AESCULAP Repair Hotline Phone: +1 (800) 214-3392 Fax: +1 (314) 895-4420 Distributor in the US/ Contact in Canada AESCULAP Inc. 3773 Corporate Parkway Center Valley, PA 18034 Phone: +1-800-282-9000 www.aesculapusa.com

9

0 11

range not adjustable

20

19

valve is flattened on one side

Fig. 19: Schematic X-ray image

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| INSTRUCTIONS FOR USE

INSTRUCTIONS FOR USE |

USA

RECOMMENDATION OF PRESSURE LEVELS

Adjustable unit

Gravitational unit

Standard (children and NPH-patients)

5 cmH2O

Defensive (e.g. patients with extremely wide ventricles and highly elevated ICP or aqueductal stenosis

10 cmH2O

Special (e.g. patients with pseudotumor cerebri)

15 cmH2O

Children up to 5 years Children over 5 years and Adults up to 60 years Adults over 60 years

20 cmH2O 25 cmH2O 20 cmH2O

Body-Mass-Index (BMI)

height in cm

weight in kg 150

125

BMI

140 70

135

extremely adipose 140

adipose

150

110

50

100 95 90 85

level II level I

80 30

155

overweight

20

175

rson: ,5 MI 21 e.g. pe kg, B

180

underweight

175cm

75 70

60

normal

40 10

Control

Body position 30

200

210

< 1,60 m height: - 5 cmH2O below standard recommendation > 1,80 m height: +5 cmH2O above standard recommendation

35

195

205

Height

55

45

185

kg BMI= 2 m

25

Draw a line between height on left side and weight on right side. In the middle you can read the individual´s BMI.

Standard pressure levels are suitable for active people. Patients who are bedridden should be treated with a maximum pressure of 20 cmH2O in the gravitational unit. The hydrostatic suction effect normally depends on the height. Therefore we recommend the following corrections for the gravitational unit:

50

, 65

190

Mobility

65

160 165

120

60

40

145

170

Overweight

130

130

The peritoneal pressure inhibits drainage. Therefore the gravitational unit should consider the following adjustments concerning adipose patients as a function of body-mass-index (BMI): 25-29 BMI -5 cmH2O below standard recommendation 30-34 BMI -10 cmH2O below standard recommendation 35-39 BMI -15 cmH2O below standard recommendation >40 BMI only apply the adjustable unit (no gravitational unit necessary)

Adjustment

The adjustable unit is adjusted to 5 cmH2O by the manufacturer. Please control the pressure setting before use.

Only the adjustable unit determines the pressure level in the horizontal body position. The analogous pressure level for the vertical body position results from the addition of both - adjustable and gravitational unit.

Changing the adjustable unit also influences the opening pressure level in the vertical body position.

The recommendations are based on common patient treatments, but can vary depending on the individual patient´s condition. 16

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| INSTRUCTIONS FOR USE

INSTRUCTIONS FOR USE |

USA

VARIANTS proGAV Verification tool

proGAV Adjustment tool

proGAV Verification compass

proGAV ADJUSTMENT DISC

proGAV MASTERDISC

proGAV CHECK-MATE

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