CONTENTS Company Profile Implanted Port Titanium-Port

CONTENTS § Company Profile § Implanted Port Titanium-Port § Huber Needle Set Poly-Port § Gastric Band § Bone Marrow Biopsy Needle § Bone Marrow Aspiration Needle § Biopsy Punch § Quality Certifications ISO 13485; 2003 § Quality Certification ISO 9001; 2000 § CE Mark

COMPANY PROFILE Lexel S. R. L is an Argentine company dedicated to the Production, investigation, development and Sale in the health area. It was founded in 1991 since them become in one of the company leader of the Argentinean market. In 1997 growth to the MERCOSUR and some countries of Latin America. Lexel have a plant where elaborate their products who meet the most high standard of quality. We are certified in ISO 9001; 2000, ISO 13485; 2003 and GMP (Good Manufacturing Practice). The company also have CE mark for their products who allows to us to sale in European Union. CE 0473

IMPLANTED PORT TITANIUM-PORT Implanted Port It’s an implanted device to drugs administration built in Titanium. This made to the implanted port less heavy than others and give to it high resistance and absolutely biocompatibility. Their septum built in silicon medical grade, give the possibility of use it 3000 times with a 23 G Huber needle. Titanium-Port exists in three sizes : Adult , Pediatric and Neonatal. We also have three sizes of catheter for venous use (9 FR / 7 FR / 5, 5 FR ) built in silicon, the Artery and peritoneal models. We could provide the device in two different ways: to join the catheter to the port ( with a tricuspid safety lock) or the catheter preattached to the port. All the models could come with a Peel-Away introducer sets and tunneller Advantage • 3 Different sizes • 3 Different catheters • Complete set (2 Huber needles, tunelizator, Peel-Away introducer, Guide wire, introducer needle, 10 cc xeringe • Big diameter of puntion surface • Very light • 2 option attached or to attach Models • titanium-port venous adult 9 fr uni-shunt with peel-away introducer set • titanium-port venous adult 7 fr uni-shunt with peel-away introducer set • titanium-port venous pediatric 5 fr uni-shunt with peel-away introducer set • titanium-port venous pediatric 7 fr uni-shunt with peel-away introducer set • titanium-port venous adult 7 fr with peel-away introducer set • titanium-port venous adult 9 fr with peel-away introducer set • titanium-port venous adult Bajo perfil 7 Fr with peel-away introducer set • titanium-port venous adult Bajo Perfil 9 fr with peel-away introducer set • titanium-port venous pediatric 7 fr with peel-away introducer set • titanium-port venous pediatric 5 fr with peel-away introducer set • titanium-port venous neonatal 5 fr uni-shunt with peel-away introducer set • titanium-port venous neonatal 7 fr uni-shunt with peel-away introducer set

HUBER NEEDLE SET POLY-PORT The POLY-PORT needles have a stainless steel wall with a HUBER tip, they also have an anatomic design who make sure the insertion in the port and simplified the fixation to the patient in long infusions. They have: clamp, catheter and a universal Luer connection to universal guide. Product advantage: Models: POLY-PORT INFUSION SET HUBER 19 -G x 17 mm POLY-PORT INFUSION SET HUBER 19 -G x 25 mm POLY-PORT INFUSION SET HUBER 19 -G x 32 mm 1. Huber tip for access to implanted ports. POLY-PORT INFUSION SET HUBER 21 -G x 17 mm 2. Anatomical design to an easier use and body fixation. POLY-PORT INFUSION SET HUBER 21 -G x 25 mm 3. Catheter with clamp and Luer lock connection for universal guides. POLY-PORT INFUSION SET HUBER 21 -G x 32 mm POLY-PORT INFUSION SET HUBER 23 -G x 17 mm POLY-PORT INFUSION SET HUBER 23 -G x 25 mm POLY-PORT INFUSION SET HUBER 23 -G x 32 mm

GASTRIC BAND Lexel Gastric Band it was design for weight reduction in patient with a IMC over 40. The special design allow the fixation in the upper stomach by a n adjustable silicone ring who regulate the inside diameter by the physician for every single patient. The regulation it is made by a implantable port by an injection of saline solution. The implanted Port it is join to the band by a silicone catheter with a safety clip. Quantities With the injection of 8 cm 3 ( 3. 86 PSI) the internal diameter of the ring will be reduce in 50%. With the injection of the 18 cm 3 ( 7. 73 PSI) the ring it will be totally close. With the injection of 60 cm 3(23, 2 PSI) do not appear any leakage. The Gastric Band it is provide in individual package with a Huber needle to began the treatment.

BONE MARROW BIOPSY NEEDLE Bone marrow biopsy needle LEXEL “J” type with an anatomical design to make easier their use with a special tip to do less traumatic the insertion. Stiletto with safety security lock to assure their fixation. A Luer cup to use when the stiletto is remove. The anti-stick probe guide to push the biopsy out of the needle. The safe security cup to cover the tip of the needle at the moment of the discharge. It come in double package. Product advantage: 1. Stiletto with safety security lock to assure their fixation. 2. Anatomical design to an easier use at the moment of the insertion. 3. Auto cut tip to a painless insertion. Models: 11 G x 10 cm, 11 G x 15 cm, 8 G x 10 cm, 8 G x 15 cm

BONE MARROW ASPIRATION NEEDLE Lexel Bone marrow aspiration needle “I” style with an anatomic design to an easier handling with an stiletto with safety lock to guarantee the fixation at the moment of the aspiration. Screw stop to regulate the large of the needle 3/8” (0, 95 cm) to 1 7/8” (4, 9 cm) They’ve come in a double pouch. Sterile by ETO It’s for single use only Product advantage: 1. Stiletto with safety lock to guarantee the fixation at the moment of the aspiration. 2. Anatomic design to an easier handling at the moment of the aspiration 3. Screw stop to regulate the large of the needle. Models: 18 G x 3 cm, 16 G x 5 cm

BIOPSY PUNCH It’s use to take circular samples of the diameter of the different sizes of the stainless steel tubing in body surface Examples : Skin , ( MUCOSA) to make the histologic , bacteriologic or (MICOLOGICO) studies. The more used sizes are 2 to 6 mm. The length of the device is between 7 to 9 cm. The plastic support like also the stainless steel tubing are hollow to allow by a conic connection to extract the sample who occasionally stay into the device. Product advantage: 1. Handle design with non-skid who make easier the biopsy. 2. Extract cup to make easier the extraction and to identified the sizes. 3. Anti-stick probe guide to push the biopsy out. Model 2, Model 3, Model 4, Model 5, Model 6

QUALITY CERTIFICATION ISO 13485; 2003

QUALITY CERTIFICATION ISO 9001; 2000

CE MARK

QUALITY POLICY Develop, produce and sale products with high efficiency and safety, under the specification of national and international standards and regulatory requirements. The CEO of the company see him self like a leader who involve in all the aspects of the implementation of these quality policy. With their representative the Quality Manager responsible for the quality of the products by means of the company employs. The CEO keep in all the company personal the commitment to comply with the requirements of the ISO 9001; 2000, ISO 13485; 2003 and the Medical Device Directive 93/42. EEC Implementation of the Quality Policy Meanly the responsible for the quality of the company rest in the employs and the subcontractors. This policy is based in the follow principles and activities: • Answer to the need and requirements of the client, to ensure their satisfaction, in compliance with the specifications. • The quality like culture and way of life. • The improvement like the base of all the process of the company. • Prevention of the non conformities, instead of the detection and correction after happen. • Delegation of authority and responsibilities. • Establish the purpose of the quality , criteria and ways to get it. • Use the quality like a instrument for the saves. • Continuous training and education respect of the requirements of the quality system for all the process who involve the company like Manufacturing, Design, Service.

CONTACTS www. lexelmedical. com Info@lexelmedical. com Luis Sáenz Peña 1937 Ciudad de Buenos Aires – Argentina CP: 1135 Línea Gratuita: 0800 -444 -0424 Tel: 54 -11 -4305 -5617 Fax: 54 -11 -4305 -5165