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Microline Surgical M/L-10 Manual Del Usuario

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M/L-10 Reusable Multifire Clip Applier
INDICATIONS
The M/L-10 Clip Applier is indicated for occluding and ligating vessels, ducts, tracts and other tubular
structures during laparoscopic and general surgical procedures.
CONTRAINDICATIONS
The M/L-10 Clip Applier is not intended for use except as indicated.
INSTRUCTIONS FOR USE
The M/L-10 Multi-Fire Clip Applier consists of:
1.
One reusable autoclavable handpiece
2.
One removable stainless steel outer tube
3.
Optional sterilization tray(s) - CAT. #3705 (sold separately) & 3707 (included w/clip applier & sold
separately).
4.
One sterile disposable back-loading slide cartridge, containing Titanium medium large clips (sold
separately).
WARNING
If during the inspection of the shipping carton, one of the above items shows any sign of damage, do not use
the instrument.
LOADING CLIP APPLIER
1.
Peel the clip cartridge pouch open and remove it from the pouch.
2.
Fully squeeze the handpiece trigger against the handle (Fig. 1).
3.
Align the arrow on the back of the clip applier with the arrow of the cartridge as shown in Fig. 3 (arrow of the
cartridge should be seen on the "non-clip" side of the cartridge).
4.
Insert the cartridge all the way into the back of the handpiece (Fig. 2), making sure it is handled by its sides or
proximal end behind "the ladder" in order to avoid any displacement of clips or ladder.
5.
Release the trigger. (This will immediately engage a clip into the handpiece jaws).
6.
The instrument is ready to be used.
OPERATION NOTE
Before firing a clip, verify that the ligation site is free of any obstructions.
1.
Verify that there is a clip properly loaded in the jaws prior to inserting the clip applier through the cannula.
2.
Position the clip carefully around the vessel to be ligated.
3.
With full visualization of the ligation site, squeeze the trigger all the way so that the trigger touches the handle
to close the clip around the vessel. The trigger will not reopen until the trigger is beyond the 7
below).
4.
Releasing the trigger will open the clip applier jaws and will automatically engage the next sequential new clip.
Now the clip applier is ready for re-firing.
5.
a. For the cholangiogram procedure, whereby a clip is used to temporarily secure the catheter inside the
common cystic duct without occluding the catheter, the degree of clip closure can be adjusted. This is
accomplished by releasing the trigger anytime after the 7
capability allows for the desired amount of clip closure.
b. For maximum vessel occlusion (clip fully closed) simply depress instrument trigger fully so that the trigger
and handle are touching and then fully release so that the subsequent clip can be engaged in the jaws.
CAUTIONS
a)
If all the clips are to be used, the last two colored clips will warn the surgeon that cartridge is almost out of
clips. The clip applier should be removed from the cavity once the last colored clip has been fired. The
cartridge should then be removed and disposed.
b)
Engaging the jaws over a previously applied clip should be avoided as it may cause the handpiece to misfire.
WARNING
Make sure cartridge is removed from the handpiece after use, or prior to cleaning and sterilizing process. Microline
SURGICAL shall not be responsible of any damage occurring as a result of a non-compliance with this warning.
DISASSEMBLING THE CLIP APPLIER HANDPIECE
To disassemble clip applier for reprocessing follow the steps below:
1.
Remove and discard the disposable clip cartridge by fully squeezing the trigger against the handle as shown
on Fig.4. If all 19 clips have not been fired, squeezing the handle and removing the cartridge will engage and
release one clip. In this case, make sure to fire the engaged clip onto something such as a drape so that the
contaminated clip does not fall onto the floor, stick to the jaws or fall inside the instrument shaft potentially
causing a jam or safety hazard.
(This step serves as a warning note on the "Cleaning and Sterilization" steps. Microline SURGICAL shall not
be responsible for any damages occurring as a result of a non-compliance with this warning.
M/L-10
Multi-Fire Clip Applier
Instructions For Use
Microline SURGICAL, Inc.
50 Dunham Road
Beverly, MA 01915, USA
TEL: (978) 922-9810
FAX: (978) 922-9209
Web: www.microlinesurgical.com
Email: info@microlinesurgical.com
09-39-30 Rev. G
Fully Squeeze
Fully Squeeze
Trigger
Trigger
Cartridge
fully
inserted
Fig. 2
02/2015
th
click at the ratchet mechanism. This earlier release
ENGLISH
Fig. 1
"Non-clip"
side
of cartridge
Fig. 3
th
click (see 5

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Resumen de contenidos para Microline Surgical M/L-10

  • Página 1 ENGLISH M/L-10 Reusable Multifire Clip Applier INDICATIONS The M/L-10 Clip Applier is indicated for occluding and ligating vessels, ducts, tracts and other tubular structures during laparoscopic and general surgical procedures. CONTRAINDICATIONS The M/L-10 Clip Applier is not intended for use except as indicated.
  • Página 2 RECOMMENDED CLEANING & STERILIZATION STEPS Warning Prior to cleaning the clip applier instrument, make sure that the disposable cartridge is removed and discarded. Microline SURGICAL shall not be responsible for any damages occurring as a result of a non-compliance with this warning. Note The M/L-10 clip applier should be stored and reprocessed in a protective sterilization tray or tube.
  • Página 3 FRANÇAIS M/L-10 Pince a Clip Reutilisable a Declenchement Multiple INDICATIONS La pince à clip M/L-10 est indiquée pour l’occlusion et la ligature de vaisseaux, canaux, tractus et autres structures tubulaires au cours d’interventions chirurgicales laparoscopiques et générales. CONTRE-INDICATIONS La pince à clip M/L-10 n’est pas indiquée pour des applications autres que celles présentées ici.
  • Página 4 Remarque La pince M/L-10 doit être stockée et traitée dans un plateau ou un tube de stérilisation protégé. NETTOYAGE Immédiatement après l'utilisation chirurgicale, démontez le tube externe de la tige. Trempez l’instrument et son tube externe dans une solution de 60 ml de détergent enzymatique ENZOL® pour 4 l d'eau à 22-40 °C..
  • Página 5: Operación

    ESPAÑOL Aplicador de Clips M/L-10 Reutilizable INDICACIONES El Aplicador de clips M/L-10 está indicado para ocluir y ligar vasos, conductos, tractos y otras estructuras tubulares durante intervenciones quirúrgicas laparoscópicas y generales. CONTRAINDICACIONES El Aplicador de clips M/L-10 no está destinado para otro uso que no sea el indicado.
  • Página 6: Limpieza

    Nota El aplicador de clips M/L-10 debe almacenarse y reprocesarse en una bandeja o tubo protector para esterilización. LIMPIEZA Inmediatamente después del uso quirúrgico, extraer el tubo exterior del eje. El instrumento y su tubo exterior deben remojarse en una solución enzimática que contenga 60 ml de detergente ®...
  • Página 7 In questo caso, “sparare” la Clip rimasta su di un telo, in modo che tale Clip non più sterile, non vada a cadere su strutture sterili, causando danni. (Avvertimento importante per le Procedure di “Pulizia e Sterilizzazione” Microline SURGICAL non si riterrà responsabile per danni allo strumento derivanti da una non corretta manutenzione per scarsa attenzione a questi avvertimenti).
  • Página 8 4. Sparare un minimo di 2 clip per controllare la chiusura delle clip, l’innesto nelle ganasce e l’allineamento clip/ganascia. 5. Oltre a una pulizia corretta e completa (vedere le istruzioni) occorre assicurarsi che l’applicatore M/L-10 sia lubrificato bene fra casi: a.
  • Página 9 Aussenrohr Clockwise entfernen Outer Tube Removed Abb.6 Abb.5 Bemerkungen Benutzen Sie nur Microline SURGICAL’s sterile Wegwerfgleitpatronen zum rückwärtigen Laden - CAT #1112 und CAT # 1122. Microline SURGICAL wird für Schäden, die durch andere Clips entstanden sind, nicht haften.
  • Página 10 BEMERKUNG M/L-10 Inventarüberprüfungsprocedur (einmal im Monat auszuführen). Eine abgekürzte Kontrolle sollte jedes Mal, bevor der M/L-10 dem Chirurgen zum Gebrauch ausgehändigt wird, im OP durchgeführt werden. 1. Prüfen Sie die Branchen auf Fehlausrichtung, Schaden und Verschmutzung durch Bioabfall. 2. Prüfen Sie, ob der Schaft gerade ist. Entfernen Sie das Außenrohr und prüfen das Innere des Schaftes auf Schaden und Verschmutzung durch Bioabfall.
  • Página 11 NEDERLANDS M/L-10 Reusable Multi-Fire Clip Applier INDICATIES De M/L-10 Clip Applier is geïndiceerd voor het occluderen en ligeren van vaten, kanalen en andere buisvormige structuren bij laparoscopie en algemene chirurgische ingrepen. CONTRA-INDICATIES De M/L-10 Clip Applier is niet bestemd voor enige andere toepassing dan hier vermeld.
  • Página 12 4. Vuur ten minste 2 clips af om te controleren of de clips goed worden gesloten en goed in de kaken passen, en of de clips goed in de kaken zijn geplaatst. 5. Naast correcte, grondige reiniging (zie instructies) dient u ervoor te zorgen dat de M/L-10 tussen procedures door goed wordt gesmeerd: a.
  • Página 13 PORTUGUÊS Aplicador de Clipes Multi-Disparo M/L-10 Reutilizável INDICAÇÕES O Aplicador de Clipes M/L-10 está indicado para a oclusão e ligação de vasos, ductos, tractos e outras estruturas tubulares durante intervenções cirúrgicas gerais e laparoscópicas. CONTRA-INDICAÇÕES O Aplicador de Clipes M/L-10 não se destina a outras utilizações excepto as indicadas.
  • Página 14 A Microline SURGICAL não se responsabiliza por quaisquer danos resultantes de não conformidade com este aviso. Nota O aplicador de clipes M/L-10 deve ser guardado e reprocessado num tabuleiro ou tubo protector de esterilização. LIMPEZA Imediatamente após a utilização cirúrgica, remova o tubo exterior do eixo. O instrumento e o seu tubo exterior devem ser colocados em imersão numa solução enzimática contendo 60mL de Detergente...