Polysite Micro 2000 series - titanium

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1 Polysite série 2000 Polysite 2000 series Polysite Micro 2000 series - titanium VENOUS MICRO-PORT Non-traumatic angles Good flat stability Minimum weight PEDIATRIC * POM : polyoxymethylene Port type/ With Not preconnected ISP Pediatric 201 ISP micro-port 210 ISP titanium/pom* ISP 2016 ISP 2116 micro-port 2116 ISP titanium/pom* ISP micro-port 2107 titanium/pom* 2107 ISP Port height Diameter of pull out rod Flat lateral edges for good adherence (ml) 22 x 17 8,7 8 2,9 0,7 0,2 22 x 17 8,7 8 2,9 0,9 0,2 22 x 17 8,7 8 2,9 1 0,2 Silicone catheters characteristics. Carbothane Polyurethane catheters characteristics (Unique polycarbonate structure). PEDIATRIC ISP Silicone 0,6 1,6 0, F 210 ISP ISP 2107 Silicone 1,02 2,16 0, F 2107 ISP 8, (22G) 10 (20G) 10, (19G) 13 (22G) 20 (20G) 26 (19G) PEDIATRIC ISP 211 ISP ISP ISP 0,8 1, 600 0,06 F Polyurethane Polyurethane 1,2 1, ,13 6 F 11 (22G) 17 (20G) 17 (19G) 13 (22G) 2 (20G) 31 (19G) 2 radiopaque connecting rings (only 1 for the pre-connected references) 1 23 G straight Huber needle 1 catheter 1 x F, 6 F or 7 F sheath with J guidewire (0,02-40 cm) or J guidewire (0,03-60 cm) 1 puncture needle 20 G or 18 G, 38 or 70 mm of usuable length 1 Ø 2 or 2, mm tunneling device, 18 or 23 cm length ISP ISP : Peel-away sheath 2 : 2000 series 1 : pre-connected : F 7 : 7 F 049

2 Polysite série 3000 Polysite 3000 series Polysite Mini 3000 series - titanium VENOUS MINI-PORT MRI compatibility Titanium reservoir : - total compatibility with cytotoxic ingredients Shaped design Easy to connect Titanium-POM* association : - low weight - patient comfort - reduce the risk of turning round Port type/ With Not preconnected ISP mini-port 3107 titanium/pom* 3107 ISP ISP mini-port 3117 titanium/pom* 3117 ISP ISP mini-port 3108 titanium/pom* 3108 ISP Port height Diameter of pull out rod (ml) 32 x 21 10,1 10,, 1 0,3 32 x 21 10,1 10,, 1 0,3 32 x 21 10,1 10,, 1,2 0,3 * POM : Polyoxymethylene Silicone catheter characteristics IS ISP ISP ISP Silicone 2,16 1, ,092 7 F Silicone 2,4 1, ,12 8 F ISP ISP : Peel-away sheath 3 : 3000 series 1 : pre-connected 7 : 7 F 8 : 8 F Carbothane Polyurethane catheter characteristics (unique polycarbonate structure) Radioopaque ISP ISP 2 radiopaque connecting rings (only 1 for the pre-connected references) 1 23 G straight Huber needle 1 catheter Polyurethane 2,1 1, ,176 7 F Polyurethane 2,1 1, ,176 7 F x 7 F or 8 F sheath with J guidewire (0,03-60 cm) 1 puncture needle 18 G, 70 mm of usuable length 1 Ø 2, mm tunneling device, 23 cm length

3 Polysite High série Flow & 4019 Polysite HIGH FLOW & Titanium VENOUS HIGH FLOW PORT POLYVALENCE OF INDICATIONS Chemotherapy / Bone marrow transplantation / Parenteral nutrition /Hematology 3,1 L/hour* Type of port / * With 19G Huber needle ** POM : polyoxymethylene With Silicone catheters characteristics. No preconnected 4019 High 4019 ISP Flow port 4119 titanium/pom** 4119 ISP High ISP Flow port titanium/pom** ISP (ml/10cm)) Port height of pull out rod (ml) 37, x 22, 12,1 12,1 7,7 1,6 0, 37, x 22, 12,1 12,1 7,7 1,6 0, ISP Silicone 3,18 1,7 0, ,22 10 F ISP Silicone 3,18 1,7 0, ,22 10 F ISP ISP : Peel-away sheath 4 : 4000 series 1 : pre-connected, 10 : 10F Carbothane polyurethane catheters Characteristics (unique polycarbonate structure) Graduated every cm, with a number marking every cm from cm to 40 cm ISP ISP 2 radiopaque connecting rings (only 1 for the pre-connected references) 1 22 G straight Huber needle 1 catheter 1 x 9 F or 10 F sheath with J guidewire (0,03-60 cm) 1 puncture needle 1 Ø 2, mm tunneling device, 23 cm length (ml/10cm)) Polyurethane 2,8 1,6 0, ,23 9 F Polyurethane 2,8 1,6 0, ,23 9 F CD0418 / 002 Rcs POINTVIRGULE

4 Polysite série 4000 Polysite 4000 series Polysite standard 4000 serie - titanium VENOUS STANDARD PORT Connexion resist to a pressure P > 4, bars POM* radiopaque connecting rings MRI compatibility Titanium reservoir : - total compatibility with cytotoxic ingredients Shaped design Easy to connect Titanium-POM* combination : - low weight - patient comfort - reduce the risk of turning round Port type/ With No preconnected 4017 standard 4017 ISP port 4117 titanium / POM* 4117 ISP 4008 standard 4008 ISP port 4108 titanium / POM* 4108 ISP * POM : Polyoxymethylene Silicone catheters characteristics ISP ISP Port height Diameter of pull out rod (ml) 37, x 22, 12,1 12,1 7,7 1,0 0, 37, x 22, 12,1 12,1 7,7 1,2 0, Silicone 2,4 1,2 0, ,12 8 F Silicone 2,4 1,2 0, ,12 8 F Carbothane Polyurethane catheters characteristics (unique polycarbonate structure) ISP ISP Polyurethane 2,1 1,4 0, ,176 7 F Polyurethane 2,1 1,4 0, ,176 7 F radiopaque connecting rings (only 1 for the pre-connected references) 1 22 G straight Huber needle 1 catheter 1 x 7 F or 8 F sheath with J guidewire (0,03-60 cm) 1 puncture needle 18 G, 70 mm of usuable length 1 Ø 2, mm tunneling device, 23 cm length ISP ISP : Peel-away sheath 4 : 4000 series 1 : pre-connected 8 : 8 F 049

5 INJECTION OF CONTRAST MEDIA DURING CT SCAN OR MRI PROCEDURES POLYSITE CT SCAN COMPATIBLE See IFU Always ensure that the POLYSITE implantable port reference is listed in table hereafter before using a high pressure injector. Use an angled Huber needle (without tubing) or a Huber needle with tubing validated for high pressure injection. Select the appropriate Huber needle gauge to the viscosity of the contrast medium used, and to the implantable port reference following the recommendations in table (hereafter). Set the maximum injector pressure to 22.4 bars or 32 psi in order to guarantee the reliability of the system. Only use 19G or 20G needles for POLYSITE Standard (series 4000) and Mini (series 3000) and 20G or 22G for POLYSITE Micro (series 2000), in accordance with table hereafter. Do not inject more than 3 ml/s when using a 22G Huber needle. Always ensure that the injection circuit is fully operational (Huber needle and implantable port) by obtaining reflux of blood and injecting ml of physiological saline without difficulty. Warm the contrast medium to 37 C (100 F) before use (1). Always ensure that the catheter is equal or less than 2 cm long (do not administer this type of injection with a femoral catheter) (2) Never exceed the maximum recommended flow rate for a given port. Never inject contrast medium with a viscosity greater than that shown in table hereafter. Rinse the implantable port with 10 to 20 ml of 0.9 % NaCl before and after use followed by usual rinsing procedures. Not following these recommendations may lead to failure of the system through excess pressure or obstruction. (1) Do not respect this recommendation will lead to a 0% reduction of flow rate and cause failure of port or injection device. (2) Flow rates may be significantly reduced if a longer catheter is used.

6 Maximum flow rates recommended for injecting contrast medium. The following conditions must be observed: POLYSITE Reference Maximum recommended flow rate (ml/s) with 2 cm catheter Maximum recommended pressure (CT scan function) Viscosity (cp) / maximum recommended Iodine concentration (mgi/ml) in contrast media Recommended of angled needle (Gauge) ISP, 200 ECHO 1 210, 210 ISP, 210 ECHO Micro series 2016, 2016 ISP, 2016 ECHO ISP, 2116 ECHO cP i.e. 300 mgi/ml (e.g. :Xenetix 300, pre-warmed to 37 C)* 20G or 22G 2007 ISP, 2007 ECHO ISP, 2107 ECHO IS, 3007 ISP, 3007 ECHO IS, 3107 ISP, 3107 ECHO 3017 Mini series 3017 ISP, 3017 ECHO ISP, 3117 ECHO IS, 3008 ISP, 3008 ECHO IS, 3108 ISP, 3108 ECHO 32 psi or 22,4 bars ISP, 4017 ECHO ISP, 4117 ECHO 10cP i.e. 30 mgi/ml (e.g. : Xenetix 30, pre-warmed to 37 C)* 19G or 20G ISP, 4008 ECHO 4108 Standard series 4108 ISP, 4108 ECHO ISP, 4019 ECHO ISP, 4119 ECHO ISP, ECHO ISP, ECHO * Xenetix is a registered trade mark of Guerbet Laboratories. All these references obtained the CE Mark for the use of high flow injection of contrast media during CT procedures (compatible with high pressure injectors, cf Chapter VII/B from the instruction of use)