CUSA EXcel®+ - Medicare Technics
Contents
1. Fig 1 Low strength tissue High strength tissue Fig 2 PRODUCTS FOR SALE IN EUROPE MIDDLE EAST AND AFRICA ONLY CUSA EXcel 4 EXcel ultrasonic aspirator system Console Control panel The CUSA EXcel console is composed by orientable control panel for an easy access powerful built in pump a decontamination filter to protect the system a IV solution holder and 4 casters making the system easily moveable The footswitch has two pedals in base and allows the user to activate two functions ultrasonic vibration and fast flush V pole Arm Housing for irrigation pump head and suction pinch valve Arm housing Cooling water reservoir Console body Shelf for suction canister Xl THE LE e Casters Control Panel e Aspiration from 10 to 100 e Irrigation from 1 to 10 cc min e Amplitude from 10 to 100 e Laparoscopic Mode The system provides no suction to the handpiece until the vibration pedal is activated Prime Automatically increases irrigation rate to 30 cc min to pump irrigation fluid to the tip e Test Verifies the handpiece is working properly by increasing tip amplitude to 100 and then decreasing it to 0 e TissueSelect Exclusive feature for an increased selectivity 6 Tender package CUSA EXcel PRODUCTS FOR SALE IN EUROPE MIDDLE EAST AND AFRICA ONLY 5 CUSA EXcel handpieces All EXcel han2. Issued to Integra LifeSciences Ireland Ltd IDA Business amp Technology Park Sragh Tullamore Offaly Ireland In respect of Design and Manufacture of Ultrasonic Surgical Aspirators and associated sterile and non sterile accessories on the basis of our examination under the requirements of Council Directive 93 42 EEC Annex II Section 3 2 For and on behalf of the Brilish Standards Institution Notified Body for the above Directive Notified Body Number 0088 David Ford Director Healthcare and Testing Services First Issued 5 Apr 2007 Date 27 May 2010 Expiration Dato 4 Apr 2012 Page 1011 Validiby of this certificate i conditional on the quality salen being maintained bo the nequineemanis of fur Mracihe This nperoval axckades nil products designed and or manufactaned Dy n third party on bahali of the cmm nected on this certiicate unless specilical agreed with ESI mu anm raising standards worldwide Ye ee Tma Haish Warbij minion ag an Gee nw Te peni ee ae Shee ete pie Dg as dee _ Ro Liens Eh N l s Ed Vere vean FI LASS r ren VL LA be 13 Frk Harder Tender package CUSA EXcel PRODUCTS FOR SALE IN EUROPE MIDDLE EAST AND AFRICA ONLY 17 CUSA EXcel The following documents are valid at the date when this document was printed
3. SaberTip ShearTip Tip 23 kHz Tip MicroTip Standard Tip short Standard Tip extended Standard Tip extended curved Laparoscopic MacroTip Product C4606S C46075 46085 46095 C4610S 46115 46125 46135 46145 46155 46165 46175 Product 46005 46015 46025 46035 C4604ELT C4605S Diameter 114 mm 114 mm 114 mm 1 57 mim 1 57 mm 1 57 mim 1 98 mm 1 98 mm 1 98 mm 57 min 1 14 mm 2 85 mm outer 1 57mm Diameter 1 57 MM 1 98 mm 1 98 mm 1 98 mm 1 98 mm 2 54 outer 2 64 Length 5 64 cm 12 5 em 12 5 cm 5 28 cm 1215 em 12 15 em 4 57 cm 11 44 CM 11 44 CM 19 27 cm 11 49 11 79 cm Length 9 22 cm 7 98 cm 18 38 cm 18 38 cm 30 14 cm 7 95 Weight 680 680 680 680 680 680 680 680 680 680 680 680 Weight 1809 1809 1809 1809 1809 1809 Tender package CUSA EXcel PRODUCTS FOR SALE IN EUROPE MIDDLE EAST AND AFRICA ONLY Amplitude 191 210 microns 175 193 microns 137 155 microns 137 155 microns 117 135 microns Amplitude Straight 279 355 microns Angled 127 183 microns Straight 287 355 microns Angled 112 163 microns 287 355 microns not compatible w angled handpiece 178 229 microns not compatible w angled handpiece Straight 254 307 micron
4. cooling water system This system pumps water from a cooling water reservoir through a tube in the handpiece cable through the handpiece and through a return tube in the handpiece cable to the cooling water reservoir Cooling water flows at 35 to 50 cc min As it passes through the handpiece the water removes heat Normal handpiece temperature in sustained heavy use remains at about 40 C Use distilled water for the cooling water system because it does not contain natural minerals chemical additives or organic materials that are present in tap water Any of these impurities in tap water can cause problems within the cooling water system Tender package CUSA EXcel PRODUCTS FOR SALE IN EUROPE MIDDLE EAST AND AFRICA ONLY Tissue Selectivity fig 1 Tips used with the ultrasonic aspirator CUSA EXcel surgeons selectively remove fluid containing cellular material while fibrous and elastic tissues such as nerves and blood vessels are relatively unaffected at the ultrasonic frequencies used Other tips are designed to selectively fragment bone and other hard tissues or to aggressively and relatively unselectively remove a wide variety of soft tissues Tissue strength affects both the fragmentation rate and the ability of any ultrasonic aspirator handpiece to remove tissue Tissues with weak intracellular bonds are the easiest to fragment and include tissues with moderate or high fluid content such as certain neuro tumors M
5. 2 min for assembly Dismantling steps for cleaning Use of Torquing set Tools to connect and disconnect tips from handpieces Torquing set composed by Torque base and wrench Handpiece to fill in for each model 36 kHz straight Handpiece Type of surgery Mainly neurosurgery but wide range of applications see user manual Accessories tips etc Tips tubing torque set sterilization case maintenance depending of the offer Weight 68g Handpiece length 13 9 cm Ultrasounds frequency in Hz 36000Hz Maximum Vibration amplitude in um From 137 to 210 microns Depending of tip handpiece combination and setting Handpiece to fill in for each model 23 kHz straight Handpiece Type of surgery Mainly general and hepatic surgery but wide range of applications see user manual Accessories tips etc Tips tubing torque set sterilization case maintenance kit depending of the offer Weight 140g Handpiece length 22 2cm Ultrasounds frequency in Hz 23 000 Hz Maximum Vibration amplitude in um From 178 to 355 microns Depending of tip handpiece combination and setting 16 Tender package CUSA EXcel PRODUCTS FOR SALE IN EUROPE MIDDLE EAST AND AFRICA ONLY 10 EXcel documents The following documents are valid at date when this document was printed One should regularly chech with Integra if an updated version was issued Certificate Full Quality Assurance No CE 512756
6. 80 of humidity without condensation Tender package CUSA EXcel PRODUCTS FOR SALE IN EUROPE MIDDLE EAST AND AFRICA ONLY DEVICE SPECIFICATIONS 1 2 GENERAL PRESENTATION device mobile number of wheels blocking system for wheels DEVICE CHARACTERISTICS Technology used to produce ultrasounds and explanations Fragmentation Mode Ultrasound power Settings Fonctioning Mode Irrigation Mode Flow rate in ml min and precision Needed accessories Suction Mode Depression range in hPa and precision Yes 4 Brakes on frontal wheels and blocking system on back wheels The CUSA EXcel console provides alternating current at 23 or 36 thousand cycles per second kHz to the handpiece the frequency depends on which handpiece that are connected to the console In the handpiece the current passes through a coil which induces a magnetic field The magnetic field excites a transducer of nickel alloy laminations resulting in an oscillating motion in the transducer laminated structure vibration along its long axis The transducer vibrates at 23 or 36 kHz The transducer transmits vibrations through a metal connecting body to an attached surgical tip The frequency of vibration remains the same atthe tip 23 or 36 kHz but the amount of motion amplitude at the tip varies Lower frequency greater amplitude higher frequency smaller amplitude 100W Amplitude 10 values linear from 10
7. A EXcel documents ULTRASONICS CUSA EXcel catalogue cusa excel En lish E ILS 04 02 002 03 09 French ILS 04 02 016 01 09 German ILS 04 02 003 03 10 CUSA salesheet English ILS 04 113 01 08 French ILS 04 01 021 01 08 CUSA EXcer wallchart English ILS 04 04 007 01 08 German ILS 04 04 008 01 08 CUSA MicroTip plus salesheet English ILS 04 01 004 01 07 French cusa j exce CUSA MicroTip Plus is ILS 04 01 010 01 07 ag German en ILS 04 104 01 07 Integra LifeSciences Services France SAS Sales amp Marketing EMEA Distributed by Immeuble S quoia 2 97 all e Alexandre Borodine Parc technologique de la Porte des Alpes 69800 Saint Priest FRANCE 33 0 4 37 47 59 fax 33 0 4 37 47 59 99 emea info integralife com integralife com Customer Service International 33 O 4 37 47 59 50 33 0 4 37 47 59 25 Fax csemeaQintegralife com United Kingdom csuk orthoQintegralife com France 33 0 4 37 47 59 10 33 0 4 37 47 59 29 Fax cs ortho integralife com Benelux 32 0 2 257 4130 32 0 2 253 2466 Fax custsvcbenelux integralife com Switzerland 41 0 2 27 2123 30 41 0 2 27 2123 99 Fax custsvcsuisse integralife com N G nA Integra LifeSciences Ireland Ltd IDA Business and Technology Park Tullamore Offaly Ireland LIMIT UNCERTAINTY 2010 Integra LifeScience
8. AND AFRICA ONLY 6 2 Tips for 36 kHz Handpiece Fig 1 e PrecisionTip Series 114mm ID Smallest diameter for access in restricted areas Fig 1 e MicroTip Series 1 57mm ID Better access for delicate procedures Fig 2 Fig 2 e Standard Tip Series 1 98mm ID Larger diameter for rapid tumor debulking Fig 3 Tender package CUSA EXcel 9 PRODUCTS FOR SALE IN EUROPE MIDDLE EAST AND AFRICA ONLY CUSA EXcel 6 3 Specialty tips for 36 kHz Handpiece CUSA ShearTip e Designed for fibrous and though tumors e Exclusive ShearWave technology e Use in both Neuro and General surgery SaberTip e Designed for bone sculpting 180 Abrasive surface to avoid surrounding damages e Removal of Meningioma with bone infiltration MicroTip Plus e Designed for transnasal skull base procedures e 19 27 long 1 57 mm ID Procedures on Optic chiasm Pituitary gland hypothalamus Sella turcica 10 Tender package CUSA EXcel PRODUCTS FOR SALE IN EUROPE MIDDLE EAST AND AFRICA ONLY 6 4 Tips technical data HP 36 kHz HP 23 kHz Tip 36 kHz Tip PrecisionTip short PrecisionTip extended PrecisionTip extended curved MicroTip short MicroTip extended MicroTip extended curved Standard Tip short Standard Tip extended Standard Tip extended curved MicroTip Plus
9. CUSA EXcel Ultrasonic Aspirator tender package Limits uncertainty with Selectivity and Power jo m LIMIT UNCERTAINTY CUSA EXcel Table Of Contents NN rn 03 2 CUSAEXcel rultrasonic dspirdtors applications 03 3 EXcel ultrasonic aspirators O4 A CUSA EXcel ultrasonic aspirator SALG 06 07 PU atiis MR ea eee a ee 08 t TIDSTOF 29KHZ WMO ECC EEE 08 TT ORZ NANU 09 3 Speciality tips for 36KHZ Handpiece 10 NNN 11 CUSA EXcel T exclusives 12 aks tU UNE M EM 13 PANT pleie 14 CUSA 17 2 Tender package CUSA EXcel PRODUCTS FOR SALE IN EUROPE MIDDLE EAST AND AFRICA ONLY 1 Integra the company Integra develops manufactures and markets implants and surgical instruments used in neurosurgery reconstructive surgery orthopaedic and general surgery Integra was founded in 1989 as the result of innovation which represent technological breakthrough for the treatment of major burns The company developed the first artificial dermal regeneration matrix composed of collagen From this initial technological achievement Integra went on to develop the first dura
10. M MicroTip MacroTip PrecisionTip ShearWave and the Integra logo are trademarks or registered trademarks of Integra LifeSciences Corporation or its subsidiaries Forcefx is the property of its owner 27
11. One should regularly chech with Integra if an updated version was issued Certificate Design Examination No GE 559055 10 Integra LifoSciences Ireland Ltd IDA Business amp Technology Park Sragh Tullamore Offaly Ireland respect of Tips and Flues for CUSA EXcel Ultrasonic Surgical Aspirator System On Ihe bass of our examination under the requirements of Council Directive 3 4 2 EEC Annex Section 4 For and an behalf af he British Standards Institution a Nolified Body for the above Directive Notified Body Number 0026 David W Ford Executive Director Haallhcare and Testing Fired issued 11 Jun 2010 Data 11 Jun 2010 Expiration Date 10 Jun 2015 Paga 10914 Validity of thie cartficabs is conditional on iha qualily systen being maletanad fo he quirements of the Directive EE Ga EE raising standards Worldwide LLL D DE LLL Lui TF TE eee eee ee h rt Mou dl LE rpg srrpn sd a Led Gp Pe ui PUTAT be I gang es Pu GI VA sad Kj s Peeper 4501 find Te i4 DONO 26000 gabe meer bic B Omin gee eg Gb 18 Tender package CUSA EXcel PRODUCTS FOR SALE IN EUROPE MIDDLE EAST AND AFRICA ONLY The following documents are valid at date when this document was printed One should regularly chech with Integra if an upda
12. asured on off intervals of power and by reducing the amount of reserve power When the reserve power is significantly reduced a wider margin of safety is provided when contacting high strength tissue As the setting is increased softer tissue is still easily fragmented but stronger tissue is more resistant providing superior tactile feedback Requirements CUSA EXcel answers High selectivity mode TissueSelect feature Changing tip during procedure TipSelect feature Electrosurgery Nonecone Bone removal SaberTip Hard and fibrous tissue ablation ShearTip Transphenoidal approach MicroTip Laparoscopic surgery Laparoscopic tip Large range of tips 18 tips choice TipSelect feature TipSelect is a selective tissue removal system This system allows for the selection of the most appropriate tip based on the consistency location depth and access of tumors For added flexibility tips can be changed in the sterile field rather than the entire handpiece optimizing the handpiece for the procedure Cooling water system The high frequency vibration generates heat To reduce the heat the CUSA EXcel system includes a closed recirculating cooling water system This system pumps water from a cooling water reservoir through a tube in the handpiece cable through the handpiece and through a return tube in the handpiece cable to the cooling water reservoir Cooling water flows at 35 to 50 cc min As it pas
13. dpieces are driven by magnetostrictive technology and employs unique closed recirculating water cooling system to avoid any heat feeling for the sugeon Fig 1 COMPACT Handpiece for Neuro and General Surgery Fig 36 kHz Handpieces p T cmm M m e Length 13 9 cm 5 48 in Diameter 16 4 mm 0 65 in e Weight 68 g 2 4 02 e Maximum Amplitude 210 POWER Handpiece for Neuro and General Surgery Straight Fig 2a Fig 2a e 23kHzHandpieces straight e Length 22 2 cm 8 75 in e Diameter 20 8 mm 0 82 in e Weight 180 g 6 4 oz e Maximum Amplitude 355 um Angled Fig 2b 23kHzHandpieces angled Fig 2b e Length 22 5 cm 8 85 in e Diameter 20 8 mm 0 82 in e Weight 180 g 6 3 02 e Maximum Amplitude 185 um Tender package CUSA EXcel 7 PRODUCTS FOR SALE IN EUROPE MIDDLE EAST AND AFRICA ONLY CUSA EXcel 6 EXcel tips Fig 1 6 1 Tips for 23kHz handpiece e MicroTip 1 57mm ID Small ID for small tumors Fig 1 e Standard Tip Series 1 98mm ID Larger diameter for Fig 2a rapid tumor debulking Fig 2a e Laparoscopic Tip 1 98 mm ID Extended Life Tip ELT for Laparoscopic procedures Fig 2b Fig 2b o r e MacroTip 2 64mm ID Largest diameter tip Fig 2c Fig 2c ELT Extended Life Time Tip is 6 times reusable 8 Tender package CUSA EXcel PRODUCTS FOR SALE IN EUROPE MIDDLE EAST
14. electro surgery using the optional CUSA Electrosurgical Module CEM CUSA EXcel 3 CUSA EXcel ultrasonic aspirators technology Principle of Operation The CUSA EXcel Ultrasonic aspirator provides selective tissue fragmentation with simultaneous irrigation and aspiration The system is comprised of the console and reusable handpieces Each procedure also requires the use of a disposable or reusable tip and tubing set Magnetostrictive Technology The CUSA EXcel console provides alternating current at 23 or 36 thousand cycles per second kHz to the handpiece the frequency depends on which handpiece is connected to the console In the handpiece the current passes through coil which induces magnetic field The magnetic field excites a transducer of nickel alloy laminations resulting in an oscillating motion in the transducer laminated structure vibration along its long axis Cavitation When the tip contacts tissue the cells are fragmented as result of both the ultrasonic pressure waves generated by the impact and by the resulting acoustic cavitation Cavitation is the formation growth and implosion of vapor bubbles in the cellular liquid and is caused by the sound waves passing through the tissue When these microbubbles implode they generate a high energy pressure wave that further fragments the tissue enhancing the cellular disruption caused by the acoustic and mechanical forces generated by t
15. ender package CUSA EXcel 21 PRODUCTS FOR SALE IN EUROPE MIDDLE EAST AND AFRICA ONLY CUSA EXcel The following documents are valid at the date when this document was printed One should regularly chech with Integra if an updated version was issued INTEGRA LIFESCIENCES Tips and Flues for CUSA EXeel Ultrasonic Surgical Aspirator Systen ET E Product Code ee Panda CA6005 EXcet 23kHz MicroTip and Flue CANS 2300 Standard Tip and Flue C46025 EXeel 23kHz Straight Extended Standard Tip and Flue C46035 EXeel Curved Extended Standard Tip and Flue C46085 EXcel 23kHz MacroTip and Flue Cbs EXcel MHz t Precision Tip and Flue C46175 EXcel I 3 kHe Straighl Extended and Flue CA608S EXcel MHz Curved Extended Precision Tip and C46095 EXeel t MicroTip and Flue C46105 EXeel 36kHz Straight Extended MicroTip and Flue COE EXeel Curved Extended MicroTip and Flue C46125 1 3 kHz St Standard I Tip an and Flue C46135 EXcel 36kHz Straight Extended Standard Tip and Flue EXcel 36kHz Carved Extended Standard Tip and Flue C46 155 EXeel 3kHz E MicroTip Plus and Flue Joli Saber Tip aud Flue 46175 EXcel 36llHz ShearTip and Flue CAG178EA EXcel 3 S6kHz Shear Tip and Flue Sets comprises of 1 Tig Tip 1 Flue large O
16. eningioma liver tissues parenchyma fat and certain organs Tissues with strong intracellular bonds are the most difficult to fragment and include vessel walls ducts nerves tendons ligaments and organ capsules These structures contain less fluid and more collagen and or elastin which provide resistance to fragmentation Power Affects Tip Amplitude fig 2 The rate of fragmentation depends upon the Power setting which determines the distance of tip stroke As power increases so does the tip stroke or amplitude which results in a greater impact force and a higher tissue fragmentation rate Conversely a lower power produces a shorter stroke less impact force and slower fragmentation rate This is similar to striking a nail with a hammer Short strokes are used to tap on the nail when precise placement is the goal while long strokes requiring more power are used to drive the nail The total amount of power available is directly impacted by the amount of reserve power available to the vibrating tip Reserve power is necessary to maintain tip vibration when in contact with tissue i e when the tip is under load Like cruise control in a car going up a hill more power is provided to maintain the speed of the car Similarly a feedback system in the CUSA EXcel ultrasonic aspirator senses increased pressure when the tip is in contact with tissue and provides more power to maintain tip vibration Tender package CUSA EXcel
17. he vibrating tip Irrigation Sterile irrigation fluid flows from an Intravenous IV set bottle or bag and IV administration tubing to a variable speed peristaltic pump e The pump moves fluid at 1 to 10 cc min default flow is 3 cc min Adjustment buttons blue up down arrows on black buttons at the bottom of the irrigation display column on the control panel enable the user to increase or decrease the irrigation flow e The pump can also accelerate to a Fast Flush speed pumping at at more than 25cc min The Fast Flush pedal on the CUSA EXcel system footswitch activates the Fast Flush feature The pump pushes the fluid through the manifold irrigation tubing to a flue a sleeve surrounding the vibrating tip As the irrigation fluid passes through the flue it cools the tip When the fluid reaches the distal end of the tip as much as 99 of it passes through two pre aspiration holes in the tip eliminating fluid pooling on the sterile field and continually clearing the suction system The fluid that does not pass through the pre aspiration holes irrigates the surgical site and suspends fragmented tissue Aspiration A vacuum pump in the console body provides up to 660 mm of mercury maximum vacuum at sea level Adjustment buttons green up down arrows on black buttons at the bottom of the aspiration display column on the control panel enable the user to increase or decrease the suction from 10 to 10096 in 1096 increments The
18. k Hi Nosecone finished device THOS AGO CUSA Accessories DoC Class v1 72 CRN 10 0713 Page 2 of 2 24 Tender package CUSA EXcel PRODUCTS FOR SALE IN EUROPE MIDDLE EAST AND AFRICA ONLY The following documents valid at the date when this document was printed One should regularly with Integra if an updated version was issued Certificate Production Quality Assurance No CE 517843 issued 0 Integra LifeSciences Ireland Ltd IDA Business amp Technology Park Sragh Tullamora Offaly Ireland In respect of Those aspects of Annex V relating to securing and maintaining sterility in the manufacture of sterile disposable Excel wrench seta on the basis of our examination under the requirements of Council Directive 83 42 EEC Annex V Section 3 2 For and on behalf of the British Standards Institution a Notified Body for above Directive Notified Body Number 0086 David Ford Director Healthcare and Testing Services First issued 5 Apr 2007 Date 25 May 2010 Expiration Dato Apr 2012 Page 1 of 1 Conditipns of Appraval c thir certificaln is conditional on tho qusity syster being mantained t the requirements of the Directive This approval mariudes all products designed andlor manulactured by a third party on bela of the company named on this cortifieato urdeas specifica acroad with ae am raising standards worldwide H
19. l regeneration matrix with principle of covering the neurocranium pioneering step into the domain of neurosurgery which established Integra as one of the key players in this field In 2005 Integra sought controlled growth and chose to diversify its activities by entering the orthopaedic surgery market In 2007 the group created its Europe Middle East Africa division based in Lyon France 450 Is the number of Integra Lifesciences employees in Europe of an approximate total of 3000 employees in the Group as whole as at December 2009 7 Is the number of R amp D centres and production sites in Europe 2009 30 15 number of surgery courses organised by Integra in Europe to promote learning and knowledge sharing between surgeons 2009 Tender package CUSA EXcel PRODUCTS FOR SALE IN EUROPE MIDDLE EAST AND AFRICA ONLY 2 EXcel ultrasonic aspirators applications The ultrasonic aspirator CUSA EXcel is indicated for use in surgical procedures where fragmentation emulsification and aspiration of tissue is desirable These procedures include the following areas e Neurosurgery e Gastrointestinal and affiliated organ surgery e Urological surgery Plastic and reconstructive surgery e General surgery e Orthopaedic surgery e Gynecological surgery e Thoracic surgery e Laparoscopic surgery e Thoracoscopic surgery The CUSA EXcel system can also be combined with
20. ocedure Alternative configuration with non sterile tip and torque base is possible CUSA EXcel console Decontamination Guard Handpiece 36 or 23kHz Torque base sterilizable Disposable items required for each procedure Optional Nosecone Torquing wrench Tubing set Tip set when ESU is required 00 Tender package CUSA EXcel 13 PRODUCTS FOR SALE IN EUROPE MIDDLE EAST AND AFRICA ONLY CUSA EXcel 9 CUSA EXcel system PRODUCT INFORMATION Model Manufacturer details 1st year on market Version Delivery delay Ultrasonic Aspirator CUSA EXcel CUSA EXcel 9 Integra Lifesciences Ireland Limited IDA Business and technology park Sragh Tullamore County Offaly IRELAND 1998 VERSION 3 MINIMUM 1 WEEK MAXIMUM 1 MONTH REGULATORY COMPLIANCE European Directive 93 42 EEC CEcertificates class of device notified body CE12756 IIb BSI Product Service 0086 PHYSICAL CHARACTERISTICS amp ENVIRONMENT Dimensions L x I x h Weight kg Electrical supply voltage power Liquids supply water vacuum Cooling system Environment specificities functioning temperature hygrometry 71 12 X 55 88 X 122 95 3 kgs 220 240V 110 120 V Several fluids Internal suction pump in conformity with standards Unmineralized water for cooling system On board pump The device is equipped with a closed water cooling system 10 to 40 C 15 to
21. r Sabe dum FILES Day ai aud sti da par viker di uer ges ee ee epee 187 4 ed L ge El edd dut FME Ves mea _ Gras d rig Gud Vel di VEG PETTEE TT Tender package CUSA EXcel 25 PRODUCTS FOR SALE IN EUROPE MIDDLE EAST AND AFRICA ONLY CUSA EXcel The following documents are valid at the date when this document was printed One should regularly chech with Integra if an updated version was issued QUALITY MANAGEMENT SYSTEM 150 13485 2003 This is fo certify that Integra LifeSciences Ireland Ltd IDA Business amp Technology Park Sragh Tullamore Offaly Ireland Holds Cerificate FM 512757 and operates a Quality Managemen System which complies with the requirements af ISO 13485 2003 for he following The design and manufacture of ultrasonic surgical aspirator systems with associated adaptors hand pieces tips flues tubing and system accessones For and behalf af BST a hi Mle CMDCAS Recognized Registrar ha censi ate rema te of B and sha be emet upon BED An eiectmnic parsha can be Presed copes can be user Enigroup comi Ta he read in conquncinn velh the scope abowe or the az3ched appena Amencas Headquaten T2110 Suma Hils Plead Sud 200 Resor 20190 USA 26 Available CUS
22. ring small O ring and Tip cleaning wire Non sterile Reusable Tip in set with 6 Flues Product Code Product Description C4601ELT EXeel kle Standard Tip ae Life and Fings CAMELT CAGUSELT CAGUSELT cari oli k viria colas Leila Dn nnn EXcel kHz Curved Extended Precision Tip Extended Life nnd Flues ELT EXcel MHz Curved Extended Micro Tip Extended Life Flues CHELT EXcel Curved Extended Sianidard ind Tip Extes Extended Life nml Flies Non sterile Sets comprises of 1 reusable Tip up io 6 dines reneabiel Fines Sic small O rings and 6 Tip eleaming wires le 6 Flues 6 large rings 6 001 TIP amp Dol Clas 01 16 Bela CEN 10 0746 l age 2 of 2 Tender package CUSA EXcel 22 PRODUCTS FOR SALE IN EUROPE MIDDLE EAST AND AFRICA ONLY The following documents valid at the date when this document was printed One should regularly chech with Integra if an updated version was issued TRO3 INTEGRA LIFESCIENCES EC Declaration of Conformity By Integra LifeSciences Ireland Limited Equipment covered by this declaration ACCESSORIES FOR CUSA Excel EXeel amp CUSA EXcel EXcel 9 SYSTEMS 93 42 93 42 Annex IX Annex IX Product Group TF 3 05 Steriliser Case Tip Torquing Set Contamination Guard Tip Maintenance Kit Sterilizable Torque Ba
23. s Angled 102 142 microns Surgical applications Small shallow hard tumors Small deeper hard tumors Small deeper hard tumors Soft brain tumor Soft brain tumor Soft brain tumor Soft brain tumor Soft brain tumor Soft brain tumor Soft brain tumor Deeper applications Application where precise amp controlled removal of bone is critical Fibrous and tough tumors Cirrhotic tumors Surgical applications Harder brain tumor Liver resection Liver resection Liver resection Acute Lap Chole Hepatectomy Endometriosis Radical Prostatectomy Pelvic Lymph Node Dissection Liver resection 11 CUSA EXcel 7 EXcel exclusive features TissueSelect Technology The TissueSelect feature enables surgeons to chose a setting that maintains a high rate of tissue fragmentation while maximazing selectivity and tactile feedback from the surgical site The total amount of power available is directly related to the amount of reserve power available to the vibrating tip Reserve power is necessary to maintain tip vibration when in contact with tissue or under load This is similar to cruise control in a car going up a hill more power is provided to maintain the speed of the car TissueSelect reduces the reserve power by pulsing the energy to the tip This makes tissue destruction more controllable The TissueSelect feature provides increased selectivity both by creating periods of me
24. s Corporation All rights reserved ILS 06 06 001 01 10 PRODUCTS FOR SALE IN EUROPE MIDDLE EAST and AFRICA ONLY CUSA techbrief English sss ILS 04 105 01 07 cusa excel French hx Technical Brief TISSUE ABLATION ILS 04 109 01 07 German nin ILS 04 110 01 07 CUSA EXceF sabertip salesheet English ILS 04 103 01 07 CUSA SaberTip F re n C h Ultrasonic Bone Sculpting LS 04 10 y 01 107 German MS INTEGRA is g 0 4 4 0 4 0 1 gt 107 P i CUSA ShearTip Sheer salesheet English ILS 04 01 036 01 10 German ILS 04 01 037 01 10 DVD in service cusa excet dvd CUSA Ultrasonic Aspirator In Service Training TISSUE ABLATION FS INTEGRA English ILS 04 302 01 07 INTEGRA LIMIT UNCERTAINTY Availability of these products might from given country region to another as result of specific local regulatory approval or clearance requirements for sale in such country or region Always refer to the appropriate instructions for use for complete clinical instructions Non contractual document The manufacturer reserves the right without prior notice to modify the products in order to improve their quality WARNING Applicable laws restrict these products to sale by or on the order of a physician CUSA EXcel CUSA SaberTip ShearTip TissueSelect TipSelect CE
25. se Specimen Trap TFO3 06 Sterile Disposable Wrench Set TF03 07 i Re useable Mosecones REFs listed in Appendix I We declare under our sole responsibility that the listed produet groups are Conforming to Directive 93 42 ECC Annex VII plus Annex V Sterile this declaration is supported by compliance with the Essential Requirements and by meeting the following Standard s 150 13485 2003 Date la jl fh Faro EC Certificate Number Annex CE 517843 Sterile Notified BSI Product Services 0086 Nominated holder of documents Integra LifeSciences Ireland Limited IDA Business and Technology Park Sragh Tullamore County Offaly Ireland TROS AOIO2 USA Accessories Dot Class v1 2 10 0713 Page 1 o 2 Tender package CUSA EXcel 23 PRODUCTS FOR SALE IN EUROPE MIDDLE EAST AND AFRICA ONLY CUSA EXcel The following documents are valid at the date when this document was printed One should regularly chech with Integra if an updated version was issued INTEGRA LIFESCIENCES EC Declaration of Conformity By Integra LifeSciences Ireland Limited Appendix 1 List of Articles Reference Numbers C560 Excel 23k Hs Dispo sal able Wrench EXcel 36kHsz Disposable Wrench _ 123 Sterilizable Torque Base EXcel 36EHz Sterilizable Torque Base Spe men Trap _ EXcel 2381 Rel Nosecone finished device 36
26. ses through the handpiece the water removes heat Normal handpiece temperature in sustained heavy use remains at about 40 C Built In Suction A vacuum pump in the console body provides up to 660 mm mercury maximum vacuum at sea level It means that users don t have to connect an additional pump making the set up easier and faster Comments Increase selectivity thanks to exclusive CUSA EXcel system feature Possibility to change tip during procedure while keeping the same handpiece The patented CEM nosecone combined with Forcefx generator adds electrosurgery to the CUSA EXcel system Forcefx is a product of ValleyLab a division of Tyco healthcare group LP Selective bone removal around critical structures thanks to the abrasive design of the tip Combine ultrasound selectivity and specific design for high efficiency on tough and fibrous tissue in both neuro and hepatic applications Improved access for transnasal and other procedures requiring extended length 11 49 cm and small diameter for better visualization A 30 14 cm long tip for laparoscopic approach in general surgery procedures no need to specific handpiece Makes the CUSA ultrasonic aspirator usable in a large range of applications and surgeons more confident when using it Tender package CUSA EXcel PRODUCTS FOR SALE IN EUROPE MIDDLE EAST AND AFRICA ONLY 8 CUSA EXcel requirements Items required each pr
27. suction which produces an air stream moving toward the vacuum pump pulls irrigation fluid fragmented tissue and other materials through the distal end of the surgical tip From the tip the aspirated materials pass through the manifold suction tubing into the suction canister From the suction canister the air stream continues to flow through a contamination guard that filters any remaining particulate matter or moisture preventing them from entering the vacuum pump A suction pinch valve on the front of the console opens when the system is on and closes to stop suction in the following cases In Run Status when the Vibration pedal is released In this case the pinch valve closes for about one second then re opens to avoid any traction of tissue when removing the tip from the surgical area e When priming the irrigation system e When pressing the Fast Flush pedal e In Run Status when the Vibration pedal is released In this case the pinch valve closes for about one second then re opens n Lap Mode when the Vibration pedal is released This suction stoppage prevents depletion of the pneumoperitoneum When the System Power switch is off the suction pump remains off and the suction pinch valve remains closed A button on the front of the suction pinch valve enables the user to open the valve manually Cooling The ultrasonic vibration generates heat To reduce the heat the CUSA EXcel system includes a closed recirculating
28. ted version was issued E INTEGRA LIFESCIENCES n EC Declaration of Conformity Integra LifeSciences Ireland Limited Declare under our sole responsibility that our Product Group Equipment covered by this declaration EXcel EXcel amp CUSA EXcel 8 and CUSA EXcel CUSAEXcel 9 family of Ultrasonic Surgical Aspirator Systems Conforming to Directive 93 42 EEC Annex per Article 11 this declaration is supported by compliance with the Essential Requirements by meeting the following Standards ENS5011 EN IEC 60601 1 EN IEC 60601 1 2 EN IEC 60601 2 2 UL2601 1 150 13485 2003 Product Group 9IM4NEEC 934XNEEC AnnexIX AnnexIX Rule Class TF03 01 CUSA EXcel CUSA EXcel 8 and CUSA EXcel 9 Console TF03 02 CUSA EXcel Handpieces TFO3 04 EXcel Sterile Manifold Tubing Sterile MM ee Tony O Hanlon QA RA Manager Signed by Date 200 EC Certificate Number CE 512756 Notified Body BSI Product Certification 0086 Nominated holder of documents Integra LifeSciences Ireland Limited IDA Business amp Technology Park Sragh Tullamore Co Offaly Ireland TRO AO02 CUSA Accessories DC Class IIa Hb 1 2 10 0713 Pape 1 of 2 Tender package CUSA EXcel 19 PRODUCTS FOR SALE IN EUROPE MIDDLE EAST AND AFRICA ONLY CUSA EXcel The following documents are valid at the date when this document was printed One should reg
29. to 100 default value is 1096 Theconsole provides alternating current at 23 or 36kHz tothe handpiece and vibrations will be created by user when pushing on pedal Flow rate is from 1 to 10cc min default setting is 3cc minute 10 values linear from 1 to 10 CC MIN Tubing kit Tip s flue Internal suction pump providing suction up to 660mm of mercury Settings Touch screen to increase or decrease suction from 10 to 100 by step of 10 Needed accessories Tubing kit Tender package CUSA EXcel 15 PRODUCTS FOR SALE IN EUROPE MIDDLE EAST AND AFRICA ONLY CUSA EXcel DEVICE SPECIFICATIONS 2 2 Handpieces amp tips General characteristics Raw material for ultrasound production parts Nickel lamination and brass coil Raw material for the tip Titanium Connection between handpiece and console The handpiece is linked to the console by an electric cable and 2 silicon tubing for suction and irrigation Cables lengths 4 60 m Protocol of decontamination Handpiece and accessories should be cleaned with brush then immersed in decontamination liquid the handpiece connector can not be immersed in a liquid without CUSA caps Protocol of sterilisation Autoclave at 134 C during 18 min or what is in force in your country Max number of use handpiece 150 Tip s choice Single use or Reusable tips Assembly with sterile or non steriletorquing set according to user s choice Setting time About
30. ularly chech with Integra if an updated version was issued INTEGRA LIFESCIENCES y EC Declaration of Conformity By Integra LifeSciences Ireland Limited List of Articles Reference Numbers TFO3 ADL TUSA Accessories Dot Class Hb 13 10 0713 Pape 2 ud 2 20 Tender package CUSA EXcel PRODUCTS FOR SALE IN EUROPE MIDDLE EAST AND AFRICA ONLY The following documents valid at the date when this document was printed One should regularly chech with Integra if an updated version was issued INTEGRA LIFESCIENCES EC Declaration of Conformity By Integra LifeSciences Ireland Limited Declare under our sole responsibility that our Product covered by this declaration for Belarus Tips and Flues for the CUSA EXeel family of Ultrasonic Su rgical Aspirator Systems Conforming to Directive 93 42 EEC Annex 11 3 and Annex 11 4 per Article 11 this declaration is supported hy compliance with the Essential Requirements by mecting the following Standards ISO 13485 2003 Product Group DDIRL 00 1 EXcel Tips and Fines Signed by Date Awe 2 2916 EC Certificate Number CE559055 Notified Body BSI Product Certification 0086 Nominated holder of documents Integra LifeSciences Ireland Limited IDA Business amp Technology Park Sragh Tulinmore Offaly Ireland DOT 001 CUSA TIP amp Ehe Poti Clas HL 10 Below CRN 10 0746 Page of 2 T
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