LeMaitre 7210386 Скачать руководство пользователя страница 12

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CLEANING AND STERILIZATION

RESECTOR HANDPIECE

Follow these steps after each procedure to sterilize the resector handpiece:
1.  Dispose of the resector and tube set used during the procedure following standard protocols for disposal of biohazardous waste.
CAUTION:  Resectors and tube sets used with the TRIVEX System are for single use only. Do not resterilize. Discard after use.
2.  Disconnect the resector handpiece cable from the front panel. Screw the protective cap on to the connector end of the cable.
CAUTION: Do not disconnect the cable from the handpiece.
CAUTION:  To prevent moisture from entering the handpiece cable during sterilization ensures that the protective cap is screwed on completely. Moisture 

can damage the cable or handpiece connectors.

3.  Set the suction to fully open by releasing the pinch valve on the suction tube. 
4.  Clean the unit thoroughly with soapy water 

by hand only

.  The unit may be immersed.

CAUTION: Do not use ultrasonic cleaners or automated washers to clean the handpiece. 
5.  Clean the drain tube with a brush. Rinse the unit thoroughly with water. Do not use saline or solvents such as alcohol or acetone. 
6.  Thoroughly dry the unit using compressed air to evacuate water out of crevices. 
7.  Sterilize the handpiece using one of the following methods:
• 

Steam, pre-vacuum, wrapped at 270° F to 275° F (132° C to 135° C) for four minutes.

• 

Steam, gravity method, wrapped at 270° F to 275° F (132° C to 135° C) for ten minutes.

CAUTION:  Do not cool the resector handpiece by immersing it in cold water.

TRIVEX SYSTEM CONTROL UNIT AND FOOTSWITCHES

The TRIVEX System control unit operates outside of the sterile field and does not require sterilization. Sterilization and/or disinfection procedures will 

damage the product and void the warranty. Follow these steps after each procedure to clean the control unit:

1.  Disconnect the TRIVEX System from the electrical source.
2.  Wipe the console with a clean damp cloth and mild germicide or isopropyl alcohol.

CAUTION:  Do not sterilize or immerse the TRIVEX System console in disinfectant.

Wipe the footswitches and footswitch cables with a clean damp cloth.

FIBER OPTIC CABLE

See the Fiber Optic Cable Instructions for Use (R2603) for proper cleaning and sterilization procedures.

TRIVEX SYSTEM ILLUMINATOR

See the TRIVEX System Illuminator Instructions for Use (R2596) for proper cleaning and sterilization procedures.

MAINTENANCE

ELECTRICAL INTERFERENCE 

CAUTION: This equipment is designed and tested to minimize interference with other electrical equipment. However, if interference occurs with other equipment 
it may be corrected by one or more of the following measures:

• 

Reorient or relocate this equipment, the other equipment, or both.

• 

Increase the separation between the pieces of equipment.

• 

Connect the pieces of equipment into different outlets  or circuits.

• 

Consult  a biomedical engineer.

ENVIRONMENTAL PROTECTION

CAUTION:  This equipment contains electronic printed circuit assemblies. At the end of the useful life of the equipment it should be disposed of in accordance with 

any applicable national or institutional related policy relating to obsolete electronic equipment.

PREVENTATIVE MAINTENANCE

Recommended Electrical Safety Checks
Three safety tests are conducted on each unit during factory acceptance testing:
• 

Dielectric Strength Test

• 

Ground Continuity Test

• 

Leakage Current Test

LeMaitre Vascular recommends that these tests be performed regularly to assure continued compliance with applicable safety requirements. These tests 
should be conducted in accordance with specifications IEC 60601-1.

CAUTION:  Electrical safety testing should be performed by a biomedical engineer or other qualified person.
WARNING: HIGH VOLTAGE is present during electrical safety testing. Exercise extreme caution to prevent personal injury from electrical shock, or damage to the 
equipment.  Ensure that only authorized personnel are in the test area during the tests.

Содержание 7210386

Страница 1: ...LeMaitre VASCULAR Outlines Original Artwork TRIVEX System TRIVEX System Operation Service Manual English Syst me TRIVEX Manuel d Utilisation Entretien Fran ais TRIVEX...

Страница 2: ...Lock 11 TRIVEX System Illuminator Irrigation 11 TRIVEX System Illuminator Control 11 Cleaning And Sterilization 12 Resector Handpiece 12 TRIVEX System Control Unit and Footswitches 12 Fiber Optic Cabl...

Страница 3: ...bulatory phlebectomy surgery using powered instruments Healthy tissue can be injured by improper use of theTRIVEX System resector Use every available means to avoid such injury TRIVEX Resector Kits ar...

Страница 4: ...he handpiece cable during sterilization ensure that the protective cap is screwed on completely Moisture can damage the cable or handpiece connectors Do not allow the rotating portion of any resector...

Страница 5: ...handpiece TheTRIVEX System stand provides a mobile base for theTRIVEX System control unit and an irrigation mast for the saline and tumescence solution irrigation bags The 50 watt metal halide arc la...

Страница 6: ...nch and then place the handle inside the box section of the mast weldment Orient the handle so the threaded inserts align with the hole openings in the box section of the weldment Secure the handle wi...

Страница 7: ...00 rpm steps over a range of 100 rpm to 1500 rpm 14 Resector Mode Select Button The Resector Mode button is used to change the resector direction between Oscillate Forward and Reverse 15 Resector Mode...

Страница 8: ...erify operation 5 Connect theTRIVEX System Illuminator andTumescence Pump footswitches and verify operation POWER UP CAUTION Ensure that the available mains voltage matches the data listed on the labe...

Страница 9: ...olution tubing into the Saline Pump and snap the green tubing fittings into the corresponding green brackets Ensure that the tubing rests securely in the tubing forks CAUTION UseonlyTRIVEXSystemResect...

Страница 10: ...nce Pump Footswitches to the Footswitch connectors NOTE TheTRIVEXSystemstartsupwiththeTumescencepumpOFF TheTumescencePumpmust beturnedonusingtheTumescencePumpON OFFbuttonbeforethefootswitcheswillwork...

Страница 11: ...aged replaceitimmediately CAUTION Excessiveleverageontheresectordoesnotimprovecuttingperformanceand inextremecases mayresultinwearanddegradationoftheinnerassembly CUTTING Cutting takes place when the...

Страница 12: ...an the control unit 1 Disconnect theTRIVEX System from the electrical source 2 Wipe the console with a clean damp cloth and mild germicide or isopropyl alcohol CAUTION DonotsterilizeorimmersetheTRIVEX...

Страница 13: ...and reinstall circuit boards as necessary CAUTION ReplacethelamponlywithanappropriateLeMaitreVascular ReplacementLamp REF7210115 asspecifiedfortheTRIVEXSystem Useofanyother lampwillvoidthewarranty CA...

Страница 14: ...rong light source portal adaptor attached to fiber optic cable Use only theTRIVEX System Light Source adaptor REF 7210375 Resector Mode Select button indicator light is flashing green Moisture in rese...

Страница 15: ...rWindow Lock Tumescence Pump Flow Buttons Two momentary push buttons for increasing or decreasingTumescence pump flow Saline Pump Flow Buttons Two momentary push buttons for increasing or decreasing S...

Страница 16: ...onment specified below The customer or the user of the LeMaitreVascularTRIVEX System should assure that it is used in such an environment ImmunityTest IEC 60601Test Level Compliance Level Electromagne...

Страница 17: ...cable RF compliance level above the LeMaitreVascularTRIVEX System should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorien...

Страница 18: ...use the user should contact LeMaitreVascular to see if additional product information is available HARDWARE REFURBISHED If you purchased a refurbished device then the following warranty applies Limite...

Страница 19: ...reVascular representative Next day delivery is not offered in all countries REPAIR SERVICE PROGRAM For devices no longer under warranty repairs can be made by LeMaitreVascular Non warranty repairs wil...

Страница 20: ...ent de l illuminateur 28 Utilisation 28 29 Contr le du r secteur 29 Contr le d irrigation de la pi ce main du r secteur 29 Vitesse du r secteur 29 Coupe 29 Blocage de fen tre 29 30 Irrigation de l ill...

Страница 21: ...les c bles et les accessoires En sortant le Syst meTRIVEX et les accessoires du conteneur d exp dition examiner le contenu afin de v rifier que tous les composants r pertori s dans la section D ballag...

Страница 22: ...ement possible afin de garantir un bon fonctionnement S il est endommag ne pas utiliser le dispositif V rifier que la pi ce main du r secteur et son c ble sont st riles V rifier que l Illuminateur le...

Страница 23: ...locaux et ou f d raux COMPOSANTS DU SYST ME Le Syst meTRIVEX se compose de plusieurs l ments L unit de commande du Syst meTRIVEX fournit des contr les du mode et de la vitesse du R secteurTRIVEX d act...

Страница 24: ...le sens horaire Plier la cl du loquet plat 5 Replacer le panneau arri re et r ins rer les quatre boulons MONTAGE DE LA POIGN E SUR LE MONTANT 6 Retirer les quatre boulons de montage du montant d irrig...

Страница 25: ...chaque c t du bouton de S lection du mode du r secteur s illumine en vert Lorsque le r secteur est en mode Avant les deux fl ches droites s illuminent en vert Lorsque le r secteur est en mode Arri re...

Страница 26: ...i ce main du r secteur connecter la Pi ce main du r secteur et v rifier son fonctionnement 5 Connecter l Illuminateur du Syst meTRIVEX et les p dales de la pompe turgescence et v rifier son fonctionne...

Страница 27: ...e les touches de tubulure ne percent pas la tubulure de solution de turgescence 6 Raccorder la tubulure la Poche de solution de turgescence REMARQUE latubuluredeSolutiondeturgescencedoitseulement trer...

Страница 28: ...ouvre le c ble de fibre optique r duisent la transmission globale de la lumi re 2 En dirigeant une extr mit du c ble vers une lumi re vive examiner l autre extr mit pour y d celer toute trace d endomm...

Страница 29: ...ase Augmentation du d bit ou Flow Decrease Diminution du d bit qui se trouvent au dessus de l Affichage du d bit de la pompe s rum physiologique La Pompe s rum physiologique propose cinq r glages de D...

Страница 30: ...dessous apr s chaque proc dure pour st riliser la pi ce main du r secteur 1 Jeter le r secteur et le jeu de tubes utilis s pendant la proc dure selon les protocoles standard relatifs l limination des...

Страница 31: ...odique des grilles des ventilateurs sur le panneau arri re de l unit de commande du Syst meTRIVEX Utiliser une brosse douce pour d coller et liminer toute salet accumul e sur les grilles des ventilate...

Страница 32: ...tateur le c ble de la pi ce main du r secteur et tous les jeux de tubes 3 l aide de la cl Allen de 0 48 cm 3 16 po po situ e sur la base du montant d irrigation retirer les quatre boulons de montage e...

Страница 33: ...ue l on rel che le bouton Run Ex cuter de la pi ce main Avertissement d intensit lev e dans la pi ce main du r secteur Contacter le repr sentant LeMaitreVascular La Pi ce main du r secteur ne fonction...

Страница 34: ...deux boutons poussoirs momentan s pour d marrer ou arr ter la Pompe s rum physiologique ou la Pompe solution de turgescence Connecteurs port de Source de lumi re deux connecteurs de c ble des P dales...

Страница 35: ...rer qu il est utilis dans un environnement conforme ces sp cifications Test d immunit Niveau de test CEI 60601 Niveau de conformit Environnement lectromagn tique Conseils D charge lectrostatique ESD C...

Страница 36: ...Syst meTRIVEX de LeMaitreVascular doit tre surveill afin d en v rifier le bon fonctionnement En cas de dysfonc tionnement des mesures suppl mentaires peuvent se r v ler n cessaires notamment une r ori...

Страница 37: ...a LeMaitreVascular pour savoir si des informations suppl mentaires sur le produit sont disponibles MAT RIEL RECONDITIONN Si vous avez achet un appareil reconditionn la garantie suivante s applique Pro...

Страница 38: ...n n est pas propos e dans tous les pays PROGRAMME DE SERVICE DE R PARATION Pour les appareils qui ne sont plus couverts par la garantie les r parations peuvent tre r alis es par LeMaitreVascular Les r...

Страница 39: ...24 24 25 24 25 25 25 25 26 27 27 27 27 27 28 28 29 TRIVEX 29 29 TRIVEX 30 30 30 30 31 31 31 31 TRIVEX 32 TRIVEX 32 32 32 TRIVEX 33 33 TRIVEX 33 33 33 33 33 33 34 34 TRIVEX 34 TRIVEX 34 35 36 37 38 39...

Страница 40: ...40 TRIVEX TRIVEX TRIVEX TRIVEX TRIVEX TRIVEX TRIVEX TRIVEX TRIVEX TRIVEX TRIVEX LeMaitre Vascular TRIVEX TRIVEX TRIVEX 2200026 TRIVEX TRIVEX TRIVEX...

Страница 41: ...VEX TRIVEX TRIVEX LeMaitre Vascular IEC 60601 1 IEC 60601 1 UL 60601 1 IEC 60601 1 TRIVEX 1500 VAC TRIVEX CCC 3 TRIVEX IEC 60601 TRIVEX LeMaitre Vascular TRIVEX TRIVEX LeMaitre Vascular TRIVEX TRIVEX...

Страница 42: ...42 TRIVEX TRIVEX 7210375 LeMaitre Vascular TRIVEX 7210115 IEC 60601 1 2 TRIVEX TRIVEX TRIVEX TRIVEX LED TRIVEX TRIVEX TRIVEX 50 TRIVEX LeMaitre Vascular 4 5 TRIVEX 7209514 5 5 TRIVEX 7209515 TRIVEX 3...

Страница 43: ...43 TRIVEX TRIVEX 7210351 TRIVEX 1059 00 LeMaitre Vascular TRIVEX LeMaitre Vascular 1 11 9 8 7 6 5 4 3 2 10 1 2 2 3 4 5 6 7 8 TRIVEX 9 TRIVEX 10 TRIVEX 11 2...

Страница 44: ...44 1 2 3 16 3 2 4 5 6 7 3 16 1 4 20 x 5 8 1 4 20 x 5 8 8 TRIVEX TRIVEX 2 3 1 3 2 4 5 6 1 2 3 TRIVEX 4 TRIVEX 7210375...

Страница 45: ...VEX 6 8 9 7 19 10 11 12 14 15 13 17 16 18 LeMaitre VASCULAR TRIVEX System 4 7 8 LED 9 10 11 12 100 rpm 13 rpm 100 rpm 1500 rpm 100 rpm 14 Oscillate Forward Reverse 15 Oscillate Forward Reverse 16 LED...

Страница 46: ...46 100 240 V 50 60 Hz 6 3 A 250 V 15 TRIVEX TRIVEX 1 TRIVEX 2 TRIVEX 3 4 5 TRIVEX 1 2 I 2 1 5...

Страница 47: ...47 3 TRIVEX 4 450 1 Oscillate 500 rpm 1 TRIVEX 3 2 3 4 TRIVEX 7209513 5 6 TRIVEX 7 1 TRIVEX 2 3 4 TRIVEX 7209514 7209515...

Страница 48: ...48 5 6 7 TRIVEX TRIVEX 1 2 3 4 TRIVEX 1061199 5 6 Oscillate 7 Forward Reverse 8 TRIVEX 9 600 TRIVEX 1 2 7 3 TRIVEX ACMI 2141 TRIVEX 4 TRIVEX 7210375 6...

Страница 49: ...49 TRIVEX 7210375 5 6 TRIVEX TRIVEX TRIVEX LeMaitre Vascular TRIVEX TRIVEX 8 Forward Reverse Oscillate TRIVEX Oscillate TRIVEX TRIVEX TRIVEX TRIVEX 600 7 8...

Страница 50: ...50 1 9 2 10 TRIVEX 1 50 50 175 rpm TRIVEX 500 rpm 100 rpm 100 rpm 1500 rpm 100 rpm 9 10...

Страница 51: ...51 TRIVEX TRIVEX 4 450 300 500 TRIVEX TRIVEX TRIVEX 10 30 30 10 40 1 TRIVEX 2 3 O 4 5 6 132 135 4 132 135 10...

Страница 52: ...52 TRIVEX TRIVEX 1 TRIVEX 2 TRIVEX 7209791 IPX8 10600351 TRIVEX TRIVEX 1059 00 LeMaitre Vascular IEC 60601 1 LeMaitre Vascular TRIVEX TRIVEX...

Страница 53: ...ascular LeMaitre Vascular RA Return authorization LeMaitre Vascular LeMaitre Vascular LeMaitre Vascular 1061448 LeMaitre Vascular TRIVEX 7210115 TRIVEX 6 3 A 250 V 100 240 V 10 1 2 3 4 5 6 3 A 250 V 6...

Страница 54: ...54 LeMaitre Vascular 1 TRIVEX 2 3 3 16 4 3 16 5 6 TRIVEX TRIVEX LeMaitre Vascular TRIVEX TRIVEX TRIVEX 10 40 TRIVEX 7210375 LeMaitre Vascular LeMaitre Vascular...

Страница 55: ...55 TRIVEX E 01 E 15 LeMaitre Vascular TRIVEX 7210386 57 4 x 61 47 x 162 56 36 29 100 120 200 240 V 50 60 Hz 350 VA Class 1 I Type BF BF 50 4...

Страница 56: ...8100305 TRIVEX 7210387 18 03 0 24 3 TRIVEX 7209791 10 16 x 13 97 x 4 45 0 21 TRIVEX 2141 TRIVEX ACMI 1061421 7205180 7209513 7209514 4 5 TRIVEX 100 SV 7209515 5 5 TRIVEX 200 LV 7209791 TRIVEX 7210115...

Страница 57: ...TRIVEX CISPR 11 A LeMaitre Vascular TRIVEX IEC 61000 3 2 A IEC 61000 3 3 LeMaitre Vascular TRIVEX LeMaitre Vascular TRIVEX IEC 60601 IEC 61000 4 2 6 kV 8 kV 6 kV 8 kV 30 IEC 61000 4 4 2 kV 1 kV 2 kV...

Страница 58: ...LeMaitre Vascular TRIVEX LeMaitre Vascular TRIVEX LeMaitre Vascular TRIVEX b 150 kHz 80 MHz 3 V m LeMaitre Vascular TRIVEX LeMaitre Vascular TRIVEX LeMaitre Vascular TRIVEX LeMaitre Vascular TRIVEX W...

Страница 59: ...59 LeMaitre Vascular LeMaitre Vascular LeMaitre Vascular LeMaitre Vascular TRIVEX 90 LeMaitre Vascular 24 24 RA 1 800 628 9470 24 LeMaitre Vascular RA LeMaitre Vascular LeMaitre Vascular...

Страница 60: ...Toggle switch Non ionizing electromagnetic radiation EQUIPMENT CLASSIFICATION Type BF Applied Part DANGEROUS VOLTAGE Danger of Electric Shock Alternating Current Catalog Number Serial Number Batch Cod...

Страница 61: ...2266 Fax 781 221 2223 LeMaitre Vascular GK 1F Kubodera Twin Tower Bldg 2 9 4 Kudan minami Chiyoda ku Tokyo 102 0074 Japan Tel 81 0 3 5215 5681 LeMaitre Vascular ULC 9135 Keele Street Suite B6 Vaughan...

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