prosa Tools Instructions for Use CHRISTOPH MIETHKE GMBH & CO. KG USA

Transcription

1 prosa Tools Instructions for Use CHRISTPH MIETHKE GMBH & C. KG 0297

2 prosa Tools CNTENT Remark 4 Indication 5 prosa VERIFICATIN TL 5 prosa MASTERDISC 5 prosa VERIFICATIN CMPASS 6 prosa ADJUSTMENT TL 6 prosa ADJUSTMENT DISC 7 Technical description 8 Physics background 9 Function of the prosa 10 Selecting the appropriate prosa 12 Adjusting the prosa 14 Reading the pressure setting from an X-ray image 17 prosa CHECK-MATE 18 Cleaning and disinfecting the prosa CHECK-MATE 18 Recommendation for sterilisation 20 Recommendation for sterilisation of the prosa CHECK-MATE 20 Cleaning recommendation for prosa TLS which are not sterilisable 20 Medical products consultant 21 General information 21 3

3 REMARK Note: In order to locate, to verifiy and to adjust either the adjustable DP-unit or the adjustable gravitational unit, different Verification and Adjustment tools are used: Tools used for the adjustable DP-unit: progav VERIFICATIN TL progav Masterdisc progav Compass progav ADJUSTMENT TL progav ADJUSTMENT DISC progav CHECK-MATE Tools used for the adjustable gravitational unit: prosa VERIFICATIN TL prosa Masterdisc prosa Compass prosa ADJUSTMENT TL prosa ADJUSTMENT DISC prosa CHECK-MATE Please verify specifically before using any tool for verifying or adjusting the opening pressure: for the adjustable DP-unit, use only progav Tools and for the adjustable gravitational unit, use only prosa Tools CAUTIN Federal law restricts this device to sale by or on order of a physician INDICATIN The Miethke prosa Adjustable Shunt System is intended to shunt cerebrospinal fluid (CSF) from the lateral ventricles of the brain into the peritoneum. PRSA VERIFICATIN TL The prosa VERIFICATIN TL is used for reading the valve opening pressure setting. 2 The marking (3) on the prosa VERIFICATIN TL must be in line with the proximal (ventricular) catheter. The tool contains two magnets. As soon as the button on the TL is pushed (2) the magnets in the tool align with the magnets in the valve. The opening pressure is shown on the scale (1). PRSA MASTERDISC The prosa VERIFICATIN TL can be easily checked by using the prosa MASTERDISC before measuring the opening pressure of the valve. n the disc the positions 0, 10, 20, 30 and 40 cmh 2 are indicated. If the prosa VERIFICATIN TL is placed on the disc the opening pressure shown by the TL should be aligned to the value of the prosa MASTERDISC. Example: The VERIFICATIN TL is put on the MASTERDISC so that the marking on the TL is in line with the value 10 cmh 2 on the MASTERDISC. The prosa VERIFICATIN TL should indicate the value of 10 cmh 2. The mode of operation of progav und prosa TLS are identical. Hence, the instructions on the following pages are classified for both progav and prosa TLS. Note: These TLS contain material which has been determined to be MR Unsafe. D NT use in or around strong magnetic fields such as MR imaging equipment. 1 3 Fig. 1: prosa VERIFICATIN TL Fig. 2: prosa MASTERDISC 4 5

4 prosa VERIFICATIN CMPASS Alongside the VERIFICATIN TL there is an additional device for measuring the adjusted opening pressure. The prosa VERIFICATIN CMPASS can be used to locate the valve when palpation is not possible. The VERIFICA- TIN CMPASS is set to the skin above the implanted valve. The opening pressure corresponds to the value indicated towards the direction of the ventricular catheter. Caution: Airbubbles inside the compass do not afffect its funcionality. prosa Adjustment tool The prosa ADJUSTMENT TL 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 prosa ADJUSTMENT TL is placed centrally on the valve. By pushing the button (3), the adjustment tip (4) appears, the brake is decoupled, the rotor turns and the adjusted pressure is set. The marking (5) on the prosa ADJUSTMENT TL has to point towards the proximal catheter (leading to the ventricle). prosa Adjustment disc The prosa ADJUSTMENT DISC offers another option to adjust the pressure setting. The prosa 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 prosa ADJUSTMENT DISC on the valve, the brake is decoupled and the opening pressure of the prosa is changed. Ensure that the pressure setting is changed no more than 16 cmh 2. (see Adjusting the prosa ) 3 Caution: Due to magnets inside the prosa TLS, do not use the prosa TLS nearby pacemakers. Further more do not use the prosa TLS nearby MRI scanner, since there is a danger of damaging the MRI-scanner Fig. 3: prosa VERIFICATIN CMPASS Fig. 4: prosa ADJUSTMENT TL Fig. 5: prosa ADJUSTMENT DISC 6 7

5 prosa CHRISTPH MIETHKE prosa CHRISTPH MIETHKE TECHNICAL DESCRIPTIN The prosa is the first hydrocephalus valve that enables the adjustment of the opening pressure in the upright position, as well as for all angles of elevation between the upright and the supine positions. This opening pressure depends on the body position of the patient. The prosa combines a differential pressure unit and an adjustable gravitational unit, (Fig. 6). The prosa comprises a robust titanium casing (1) whose proximal end contains a ball-cone valve. The sapphire ball (2) ensures the precise closure of the valve and a bow spring (4) determines the opening pressure of the ball-in-cone valve. The tantalum weight (3) is connected to the spring and keeps the sapphire ball in its position. In this way, optimal CSF drainage is ensured for each individual patient in any body position. The tension of the spring, and thus the valve opening pressure, can be adjusted by turning the rotor (5), with the valve implanted under the patient s skin. The cerebrospinal fluid flows in through the inlet port (6) and flows out by way of the outlet port (7). Intraventricular pressure pening pressure in horizontal positi- (DP-unit only) pening pressure in vertical position (DP-unit + gravitational unit) Pressure in the abdominal cavity Hydrostatic pressure IVP P Vli on P Vst P B P Hyd horizontal: IVP = P Vli + P B vertical: IVP = P Hyd - P Vst - P B P Vli P Hyd IVP P Vst IVP P B P B 1 titanium casing 2 sapphire ball 3 tantalum weight 4 bow spring 5 rotor 6 inlet connector 7 outlet connector 8 spiral spring 9 ligature 10 catheter adjustable gravitational unit 4 5 differential pressure unit Fig. 7: Calculating the intraventricular pressure PHYSICS BACKGRUND The intraventricular pressure is positive in a healthy human in the horizontal position. To adjust this pressure through shunt drainage, the appropriate pressure range must be chosen, taking into account the abdominal cavity pressure. The resulting IVP is the sum of the shunt opening pressure and the abdominal cavity pressure (Fig. 7). The ventricular pressure in a healthy human when moving to the 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 for the change in pressure differential. This is equal to the hydrostatic pressure minus the sum of the abdominal cavity pressure and the slightly negative intraventricular pressure. Conventional shunts open immediately as soon as the patient stands up, which can lead to critical overdrainage. 1 7 Fig. 6: Schematic cross section of the prosa 8 9

6 FUNCTIN F THE prosa Horizontal body position With the prosa in the horizontal position (Fig. 8), the weight (2) does not affect the sapphire ball. Hence, in this configuration the prosa is open, and the force brought to bear by the weight does not counteract the fluid pressure. The ventricular pressure is now controlled solely by the differential-pressure valve installed. Vertical body position In the vertical position, the DP-unit and the gravitational unit of the prosa work together. The total opening pressure is the sum of the opening pressures of the DP-unit and the adjustable gravitational unit. If the IVP (intraventricular pressure) of the patient and the hydrostatic pressure exceed this opening pressure, the closing ball of the prosa is pushed away from the cone seal and a gap opens for fluid drainage (Fig. 9). The valve system prevents increases in intraventricular pressure above the physiological range. To ensure optimal CSF drainage for each individual patient in any body position, the opening pressure of the adjustable gravitational unit can be adjusted from 0 to 40 cmh 2. The adjustment can be achieved non-invasively using the prosa TLSET, preventing the need for further surgery. 2 1 a) b) a) b) Fig. 8: DP-unit a) closed and b) open The operating principle of the DP-unit is illustrated in Fig. 8. a) and b) Fig. 8 a shows the DP-unit in the horizontal position. The ball-cone valve is closed and drainage is prevented. If the patient s IVP increases and continues to rise, the spring pressure of the ball-cone unit will be overcome. The sealing ball will move away from the cone and a gap will open for fluid drainage. Fig. 9: gravitational unit in vertical body position a) closed b) open 10 11

7 SELECTING THE APPRPRIATE prosa The prosa is a position-dependent valve, that means the opening pressure changes depending on the body position of the patient. Hence, one opening pressure for the horizontal position and one for the vertical position is set to fit the prosa individually to the patient. (see recommendation for pressure levels: Horizontal position In the horizontal position the gravitational unit doesn t have any resistance. nly the differential pressure unit determines the opening pressure of the whole shunt - ystem. As standard configuration we recommend a differential pressure unit with opening pressure of 5 cmh 2. Vertical position In the vertical position the opening pressure of the complete shunt system is the sum of the opening pressure of the differential unit and the opening pressure of the gravitational unit. The opening pressure of the gravitational unit should be chosen depending on height, weight and age of the patient. opening pressure differential pressure unit opening pressure gravitational unit opening pressure differential pressure unit recommendation opening pressure gravitational unit standard 5 cmh 2 children up to 5 years 20 cmh 2 opening pressure of the whole shunt system defensive* = 10 cmh cmh 2 opening pressure of the whole shunt system = + opening pressure of the differential unit adults up to 60 years 25 cmh 2 special** 15 cmh 2 adults over 60 years 20 cmh 2 *e.g. patients with extremely wide ventricles and highly elevated ICP or aqueductal stenosis **e.g. patients mit pseudotumor cerebri The recommendations are based on common patient treatments, but can vary depending on the individual patient s condition

8 ADJUSTING THE prosa Please verfify specifically before using any TL for verifying or adjusting the opening pressure: for the adjustable DP-unit, use only progav Tools 2. Measuring the opening pressure The prosa VERIFICATIN TL is positioned centrally over the valve. (Fig. 11). The notch on the TL must point towards the proximal catheter (leading to the ventricle). 3. Adjusting the opening pressure 3a. Adjustment with the prosa ADJUSTMENT TL The prosa ADJUSTMENT TL is set to the required opening pressure by turning the knurled dial of the unit (Fig. 13). and for the adjustable gravitational-unit, use only prosa Tools Abb. 14b: Adjusting the pressure setting Each prosa is calibrated under strict quality control procedures. The adjustable gravitational unit is preset to 20 cmh 2, but must be checked before implantation. The adjustment procedure is outlined in the steps below: 1. Locating the prosa The adjustable gravitational unit is located under the skin (Fig. 10). Fig. 11: Place centrally over the valve The arrow on the bottom side of the prosa VERIFICATIN TL indicates the direction of CSF-flow. The button is pushed and the pressure setting is read (Fig. 12). a) b) Fig. 13: Setting the prosa ADJUSTMENT TL Caution: Please ensure that the opening pressure is changed by no more than 16 cmh 2 per each adjustment. (see Nr. 4) The prosa ADJUSTMENT TL is positioned centrally on the valve. The notch on the TL and the scale (a) must point towards the proximal catheter (b) (leading to the ventricle), see Fig. 14a. b) a) Caution: Ensure that the TL remains close to the valve during the adjustment procedure. When treating patients who have a low tolerance to pain, local anaesthesia (e.g. applied through a plaster) should be considered, in cases where contraindication can be excluded. If the site of implantation is poorly selected or if the skin over the valve is too thick, an adjustment of the prosa can be difficult or sometimes impossible. The valve then behaves like a gravitational valve with one opening pressure for a given position. Patients should discuss the risks involved with their surgeon. progav CHRISTPH MIETHKE Caution: Improper use of the prosa ADJUST- MENT TL may result in the damage of the prosa valve. Such damage may lead to loss of shunt integrity, and necessitate premature surgical revision of the shunt system. Fig. 12: Measuring the pressure setting a) correctly, b) incorrectly Caution: Failing to centre the prosa VERI- FICATIN TL over the valve can lead to erroneous readings! Fig. 14a: Positioning the prosa ADJUSTMENT TL As soon as the prosa ADJUSTMENT TL has been positioned centrally over the valve, the button is pushed and the adjustment tip appears to apply pressure to the valve. This triggers the mechanical decoupling of the rotor and the valve setting is adjusted to the required opening pressure setting (Fig. 14b). When adjusting the prosa preoperatively through the packaging, moderate force with the prosa ADJUSTMENT TL is sufficient. D NT USE THE BUTTN! Strong pressure can cause damage to the housing, which might affect valve function. Caution: Due to postoperative swelling of the skin the adjustment of the valve setting may be difficult within the first few days. Fig. 10: Locating the valve Caution: X-ray confirmation may still be necessary for patients with scalp thicknesses greater than or equal to 5 mm thick

9 3b. Adjustment with the prosa ADJUST- MENT DISC Center the prosa ADJUSTMENT DISC over the gravitational unit of the prosa and align the desired pressure setting (b) on top of the disc in direction of the ventricular catheter (c), see Fig. 15a. For changing the opening pressure, press down the prosa adjustment disc and release (Fig. 15b). Do not press and turn. Finally, remove the prosa ADJUSTMENT DISC and confirm the setting with the prosa VERIFICATIN TL. 4. Verifying after adjustment After adjusting the valve by using the Adjustment Tool, it can be verified using the Verification Tool, 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 valve using the prosa ADJUSTMENT TL, it can be verified using the prosa VERIFICATIN TL and may be confirmed by radiograph (X-ray). During the adjustment, the opening pressure should not be changed more than 16 cmh 2 at a time. The following table shows the quantitative information regarding the overall agreement rates between the X-ray and the respective verification tool for the prosa valve. The maximum deviation from the actual valve readings used were 0, 1, 2, >2 cmh 2. For example at 2 cmh % of the measurements made by the prosa VERIFICATIN TL with the prosa valve deviate not more than ± 2 cmh 2 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. 40 cut-out rotor tip Fig. 17: Schematic X-ray image not adjustable range 10 0 c b Example: pening pressure is to be changed from 6 to 36 cmh 2. With only one adjustment step the rotor would turn in a counter clockwise direction (shortest path) and would stop at the position 0 cmh 2 (Fig. 16a). prosa Valve = 0 cmh 2 1 cmh 2 2 cmh 2 > 2 cmh 2 prosa VERIFICATIN TL 64.4 % 89.8 % 99.6 % 0.4 % cut-out rotor tip Abb. 15a: Center the prosa Adjustment disc on the valve range not adjustable range not adjustable 0 prosa Valve prosa VERIFICATIN CMPASS 64.9 % 96.0 % 99.6 % 0.4% Fig. 18: X-ray image position 31 cmh 2 b READING THE PRESSURE SETTING FRM AN X-RAY IMAGE c Abb. 15b: Press down slightly the prosa ADJUSTMENT DISC and release a) b) Fig. 16: Rotor rotation during adjustment The correct adjustment is performed in 2 steps: Adjustment from 6 to 22 cmh 2, and then from 22 to 36 cmh 2. The rotor turns now in a clockwise direction (Fig. 16b). Caution: If the pressure configuration of the valve cannot be determined with complete certainty by the prosa VERIFICATIN TL, the use of imaging techniques is recommended (excluding MRI: danger of artefacts). MRI examinations must be performed at field strengths no greater than 3.0 tesla. The pressure setting of the prosa should be measured with the prosa Verification Tool, but if there is any discrepancy between the desired adjustment setting and the setting that is read by the prosa Verification Tool, then a radiographic confirmation (X-ray) can be performed to confirm the actual valve setting. The magnets of the rotor are visible in the X-ray image as white dots (Fig. 17). The orientation of the rotor tip indicates the pressure setting. The rotor tip can take any position outside the region indicated shown below (Fig. 17). Thus, the opening pressure of the adjustable gravitational unit can be adjusted from 0 to 40 cmh 2, in increments of 1 cmh 2. To further assist correct identification of the adjusted opening pressure, a cut-out in the casing ring is visible under X-ray imaging (Fig. 18)

10 prosa CHECK-MATE The prosa CHECK-MATE is delivered sterile and is intended to be re-sterilised. It is possible to change and to verify an applied pressure setting on the valve directly in the R. To verify the actual pressure setting the prosa CHECK-MATE has to be put centrally over the valve. The prosa CHECK-MATE will immediately start to move. If it remains stable, the pressure setting can be read in allignment to the inlet connector. To adjust a new pressure setting, the prosa CHECK-MATE has to be placed centrally over the valve. The new pressure setting has to point towards the proximal catheter (leading to the ventricle). By pressing down slightly the prosa CHECK-MATE, the brake of the valve is decoupled, the rotor turns and the opening pressure of the prosa is changed. Please be aware that the steps for changing the pressure setting should not be more than 16 cmh 2 per step (see chapter Adjusting the prosa ). Fig. 19: prosa CHECK-MATE 0297 CLEANING AND DISINFECTING THE prosa CHECK-MATE 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. bserve 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 precleaning procedure for products with encrusted residues, in preparation for mechanical cleaning/disinfecting. as an integrated mechanical support measure for mechanical cleaning/disin fecting. for additional cleaning for products with residues left after mechanical cleaning/ disinfecting. Clean and disinfect TLs 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/disinfectin 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) I Desinfecting ultrasound cleaning t (min) Stage I Clean the product in an ultrasound cleaning bath (frequency 35 khz). Make certain that all accessible surfaces are moistened. Conc. (%) Water quality Chemical RT (cold) 15 2 D-W BBraun Stabimed; aldehyde phenol and QAV free; ph = 9 II Intermediate rinse RT (cold) 1 - D-W D-W: Drinking water, RT: Room temperature Mechanical alkaline cleaning and thermal disinfecting Stage II Rinse the product completely (all accessible surfaces) under running water. 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 Step T ( C/ F) t (min) Water quality I Prerinse <25/77 3 D-W - Chemical II Cleaning 55/ 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/ FD-W - VI Drying 90/ D-W: Drinking water, FD-W: Fully desalinated water (demineralized) 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. We recommend putting the TL in a double sterile bag after cleaning. So the next use in the theatre (sterile area) will be prepared as its best

11 RECMMENDATIN FR STERILISATIN Except the prosa CHECK-MATE, prosa TLS can not be sterilised. RECMMENDATIN FR STERILISATIN F THE PRSA CHECK-MATE The prosa CHECK-MATE should be sterilised by steam sterlization (fractionated vacuum process) at 132 C and 4 minutes cycle time. Sterilization for prosa- CHECK-MATE in the Validated Cycle: Sterilizer Type: Minimum Temperature: Full Cycle Time: Minimum Dry Time: Sample Configuration: Prevacuum 132 degrees Celsius 4 minutes 20 minutes Sterilization Container (Aesculap Steril- Container) CLEANING RECMMENDATIN FR prosa TLS WHICH ARE NT STERILISABLE Attention: prosa TLS are made from thermal unstable components which are affectable by heat or humidity or chemical agressive substances. Do not steep the prosa TL in liquids and keep the inside of the TLs dry! Remove surface pollution of the prosa TLS 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. The following cleaning methods are not allowed for the cleaning of the prosa TLs (except prosa CHECK-MATE): Irradiation, Ultrasonic, Sterilization, Machine preparation, Inserting into liquids. MEDICAL PRDUCTS CNSULTANT 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 Potsdam Phone: +49(0) or Phone: +49(0) Fax: +49(0) info@miethke.com Please address any enquiries to: AESCULAP AG Am Aesculap Platz D Tuttlingen Phone: +49 (0) Fax: +49 (0) information@aesculap.de Service address in the US AESCULAP Inc. Attn. AESCULAP Technical Services 615 Lambert Pointe Road Hazelwood, M, GENERAL INFRMATIN Manufacturer Product name Intended use Christoph Miethke GmbH & Co. KG TLS for prosa Treatment of Hydrocephalus Store in a clean, dry place CFU should be determined and lower than 10CFU per item AESCULAP Repair Hotline Phone: +1 (800) Fax: +1 (314) Distributor in the US/ Contact in Canada AESCULAP Inc Corporate Parkway Center Valley, PA Phone:

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13 0297 CE-Kennzeichnung gemäß Richtlinie 93/42/EWG CE marking according to directive 93/42/EEC Label CE conforme à la directive 93/42/CEE Identificatión CE en conformidad con la directriz 93/42/CEE Marchio CE conforme alla direttiva 93/42/CEE Technische Änderungen vorbehalten Technical alterations reserved Sous réserve de modifications techniques Sujeto a modificationes técnicas Con riserva di modifiche tecniche Manufacturer acc. MDD 93/42/EEC: CHRISTPH MIETHKE GMBH & C. KG Christoph Miethke GmbH & Co. KG Ulanenweg Potsdam Germany Phone +49 (0) Fax +49 (0) Distributed by: Aesculap AG Am Aesculap-Platz Tuttlingen Germany Phone +49 (0) Fax +49 (0) Aesculap - a B. Braun company TA GBA_73_05_0217_