Lotus handpiece Technical data sheet

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Christian Cook
6 years ago
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1 Lotus handpiece Technical data sheet

2 Manufacturer s details SRA Developments Bremridge Ashburton Devon, UK TQ13 7JX Intended use The Series 4 Lotus Coagulation and Cutting System is indicated for soft tissue surgical incisions when bleeding control and thermal injury are important. Series 4 Lotus may be used as an adjunct to or substitute for electrosurgery, laser surgery and traditional scalpels in General, Urological, Gynaecological, Bariatric, Thoracic, Hepatopancreaticobiliary surgery and exposure to orthopaedic structures (such as spine and joint space) and other endoscopic and open procedures.

3 Product name and classification The overall product name is Lotus Series 4 and has a number of product model codes as listed below: Name Dissecting Shears Open 200 Dissecting Shears Curved Handpiece Laparoscopic 400 Dissecting Shears Bariatric 500 Liver Resector Open 200 Liver Resector Laparoscopic 400 Double Blade Open 100 Double Blade Laparoscopic 400 Vessel Welder Open 200 Vessel Welder Laparoscopic 400 Single-use Handpiece Model No. Length For Use With DS4-200SD 200mm DS4-200ST or SV3-200 DS4-400CD 400mm DS4-400CT or CV3-400 DS4-500SD 500mm DS4-500ST or SV3-500 LR4-200SD 200mm LR4-200ST or LR3-200 LR4-400SD 400mm LR4-400ST or LR3-400 DB4-100SD 100mm DB4-100ST - DB3-100 DB4-400SD 400mm DB4-400ST or DB3-400 VW4-200SD 200mm VW4-200ST or W3-200 VW4-400SD 400mm VW4-400ST or W3-400 It is categorised as Class IIb according to Rule 9 of Annex IX of the Medical Device Directive.

4 Certification ISO 9001:2008 ISO 13485:2003 CMDCAS ISO 13485:2003 CE Mark (Council Directive 93/42/EEC as amended by Directive 2007/47/EC

5 Patient contacting materials PTFE (Jaw liner) Stainless Steel 304 (Inner and Outer Tubes) Hastelloy (Jaw) Sterilization method The single-use handpieces are supplied sterile in heat-sealed, single wrapped Tyvek 1073B/BOPA pouch. They are sterilized using a validated EtO procedure and residuals have been confirmed as being well within acceptable limits. The sterilization process is subcontracted to an ISO13485 certified specialist sterilization company. Latex No products within the Lotus system range contain latex, nor are they manufactured in an environment that uses latex

6 Packaging PVC (transport tray) Standard medical pouch manufactured from Tyvek 1073B, BOPA and Perfecseal s K adhesive lamination Individually packaged in cardboard

7 Material of animal origin The Lotus system contains no material of animal origin. Drug content The Lotus system contains no drug. Dissecting Shears Handpiece Liver Resector Handpiece Vessel Welder Handpiece

8 Transducer and handpiece Lotus torsion transducer Alignment fin Rubber rotation wheel Wraparound activation button Ergonomic Palm-Fit grip Handpiece Spring-loaded rubber trigger Ergonomic power select button Transducer

9 Distal tip schematic PTFE liner Metal jaw Coagulation energy Outer tube Active blade Drive cam

10 Lotus SRA Developments Ltd Bremridge House Bremridge Ashburton, Devon UK TQ13 7JX

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