Cooper Surgical Advincula Arch 53469 Manual
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The following steps must be completed prior to attaching the
Adapter to the UPS™arm:
1. Patient is positioned, prepped and the Manipulator Handle
is inserted.
2. UPS arm and patient are properly draped.
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1. Align the reinforced punch-out hole in the UPS Sterile Drape with
the Mating Hole in the UPS arm.
2. Insert the Adapter’s Engagement Pin (see Figure 1) into the UPS
arm’s Mating Hole until secure. Use the Alignment Pin for proper
orientation of the Adapter.
3. Ensure that the Adapter is securely in place on the arm.
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The following steps must be completed prior to attaching the
Manipulator Handle to the Adapter:
1. Patient is positioned for surgery.
2. Draped UPS arm and Adapter are placed in approximate position
for attachment near the proximal end of the Manipulator Handle.
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DO NOT attach the Manipulator Handle to the UPS arm
until after the patient is in final position and sedated.
1. Open the Latch on the Adapter (see Figure 2).
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16( For optimal motion, grasp only the handle of the UPS to move
the device.
2. Grasp the handle of the UPS, press the foot pedal, and move the
arm to align the Adapter with the Manipulator Handle. Take care
to minimize movement of the Manipulator Handle within the
patient.
3. Position the Mating Pin on the Adapter into the Mating Hole of the
Manipulator Handle.
4. Close and lock the Latch, and ensure that the Manipulator Handle is
securely attached to the Adapter with no free movement.
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To detach the Manipulator Handle, unlock and open the Latch on the
Adapter while holding the Manipulator Handle and separate it from
the Adapter.
16( There is no need to depress the foot pedal and move the UPS
arm to separate the Manipulator Handle from the Adapter.
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To detach the Adapter from the UPS Arm after surgery is complete,
press the Release Button on the Arm (see Figure 3) and pull the
Adapter straight out without rotation.
1. Prepare the enzymatic detergent according to the manufacturers
recommendations and submerge the Adapter in the detergent.
Soak for ten (10) minutes.
2. Scrub the submerged Adapter with a soft sponge or brush and
agitate. Clean crevices, using a pipe cleaner/brush or flush with a
syringe when appropriate. Actuate any moving parts to loosen
trapped soil.
3. Rinse in warm (100 °F – 120 °F, 38 °C – 49 °C) tap water for
one (1) minute. Thoroughly flush difficult to reach areas.
Actuate while rinsing.
4. Place the Adapter into a bath containing warm (100 °F – 120 °F,
38 °C – 49 °C) water. Agitate the Adapter by hand for at least
one (1) minute. Repeat this process two (2) additional times.
5. Ultrasonically clean the Adapter for twenty (20) minutes in a neutral
pH detergent (Neutrad®or acceptable alternative). Prepare the
detergent according to the manufacturer’s recommendations.
6. Rinse the Adapter with clean, tap water, actuating moving parts
while rinsing, for one (1) minute; repeat rinse twice.
7. Dry the Adapter thoroughly with a clean, lint free cloth.
8. Repeat this cleaning procedure if the Adapter appears to be soiled
after initial cleaning and until there is no sign of soil on the device.
#
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Preconditioning Pulses: 4
Exposure temperature: 270 °F – 273 °F (132 °C – 134 °C)
Exposure time: 4 minutes
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Exposure temperature: 270 °F – 275 °F (132 °C – 135 °C)
Exposure time: 15 minutes
Exposure temperature: 250 °F – 253 °F (121 °C – 123 °C)
Exposure time: 40 minutes
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Mating Pin
Advincula Arch Handle Advincula
Arch Adapter
Mating Hole
Latch
Mating Pin
Alignment Pin
Engagement Pin
Release Button
Arm
UPS Handle
Latch
: When securing the Latch, use care to avoid contacting
the patient or other accessories in the surgical field.
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Directions for Use (English)
U.S. Federal law restricts
this device to sale by or on the order
of a physician.
16( The parameters listed on the previous page are only a
recommendation. Sterility of the device is the responsibility of the
hospital or site performing the sterilization. (Refer to the sterilizer’s
manufacturer’s manual for detail about the sterilization unit.)
Following steam sterilization, allow all components to cool to
room temperature. Sudden changes in temperature may damage
the components.
#
• Failure to properly follow instructions for the Advincula Arch Adapter
(Adapter), including instructions supplied with the Uterine Positioning
System (UPS, 371550-03) and the Advincula Arch Uterine
Manipulator Handle (Manipulator Handle, UMH750), may lead to
injury and result in improper functioning of the system.
• The Adapter is only intended for use with the Advincula Arch
Manipulator Handle and the UPS. Use of this device with any other
Manipulator is not recommended, and could lead to injury and
improper functioning of the device.
• Surgical procedures requiring vaginal instrumentation are not sterile.
Conventional operating room procedures for maintaining sterility
must be observed when the UPS is in use.
• The Adapter is supplied non-sterile and must be cleaned and
sterilized prior to use.
• Verify that the correct Adapter is being used with the Manipulator
Handle.
• Refer to the UPS Directions for Use for further instructions.
• ALWAYS position the patient and the OR table prior to attaching the
UPS to the Manipulator Handle.
• ALWAYS have the patient under general endotracheal anesthesia
when the UPS is attached to the Manipulator Handle.
Refer to the Manipulator Handle (UMH750) Directions for Use for
applicable contraindications of the device.
U.S. Federal law restricts this device to sale by or on the order of a
physician.
Neutrad®is a registered trademark of Decon Labs, Inc.
CooperSurgical is a registered trademark of CooperSurgical, Inc.
All other marks bearing the symbols “TM” and “®” are trademarks and
registered trademarks of CooperSurgical, Inc.
© 2011 CooperSurgical, Inc. All rights reserved.
U.S. Federal law restricts this device
to sale by or on the order of a physician.
Reorder Number
Batch Code
!
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Latex Free
See instructions for use.
!"
Authorized Representative in the European
Community.
Product conforms to the Medical Device Directive
93/42/EEC
The Advincula Arch™Adapter is a reusable device that is used to
attach the Advincula Arch Uterine Manipulator Handle to the Uterine
Positioning System™exclusively.
Dispose of in accordance with all applicable Federal, State and local
Medical/Hazardous waste practices.
37340 • Rev. B • 9/11
95 Corporate Drive
Trumbull, CT 06611 USA
Phone: (800) 243-2974
Fax: (800) 262-0105
www.coopersurgical.com
37340 • Rev. B • 9/11
Leisegang Feinmechanik GmbH
Leibnizstraße 32
D-10625, Berlin GERMANY
International
Phone: (203) 601-9818
Fax: (203) 601-4747
Made in the USA
Manufactured for:
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Gebrauchsanleitung (Deutsch / German)
Laut US-Bundesgesetz
ist der Verkauf dieses Produkts nur
an Ärzte oder im Auftrag von
Ärzten erlaubt.
• Bei Nichtbefolgung der Anleitung für den Advincula Arch Adapter
(Adapter), einschließlich der Anleitung für das Uterine
Positioning System (UPS, 371550-03) und für den Advincula
Arch Gebärmutter-Manipulatorgriff (Manipulatorgriff, UMH750)
besteht die Gefahr von Verletzungen und Fehlfunktion des Systems.
• Der Adapter ist nur zur Verwendung mit dem Advincula Arch
Manipulatorgriff und dem UPS bestimmt. Die Verwendung dieses
Instruments mit einem anderen Manipulator wird nicht empfohlen und
kann zu Verletzung und Fehlfunktion des Instruments führen.
• Chirurgische Eingriffe, bei denen Vaginalinstrumente erforderlich
sind, sind unsteril. Die herkömmlichen OP-Verfahren zur Wahrung
der Sterilität sind zu beachten, wenn das UPS in Betrieb ist.
• Der Adapter wird unsteril geliefert und muss vor dem Gebrauch
gereinigt und sterilisiert werden.
• Bestätigen Sie, dass der richtige Adapter mit dem Manipulatorgriff
verwendet wird.
• Weitere Anweisungen sind der Gebrauchsanleitung für das UPS
zu entnehmen.
• Die Patientin oder der Operationstisch ist STETS vor Anschluss des
UPS am Manipulatorgriff zu positionieren.
• Die Patientin muss STETS unter endotrachealer Vollnarkose sein,
wenn das UPS am Manipulatorgriff angeschlossen wird.
Die anwendbaren ontraindikationen für die Vorrichtung sind der
Gebrauchsanleitung für den Manipulatorgriff (UMH750) zu entnehmen.
Laut US-Bundesgesetz ist der Verkauf dieses Produkts nur an Ärzte
oder im Auftrag von Ärzten erlaubt.
Neutrad®ist eine eingetragene Marke von Decon Labs, Inc.
CooperSurgical ist eine eingetragene Marke von CooperSurgical, Inc.
Alle anderen Marken mit dem Symbol „TM“ oder „®“ sind Marken und
eingetragene Marken von CooperSurgical, Inc.
© 2011 CooperSurgical, Inc. Alle Rechte vorbehalten.
Der Advincula Arch™Adapter ist eine wiederverwendbare
Vorrichtung zum ausschließlichen Anschluss des Advincula Arch
Gebärmutter-Manipulatorgriffs am Uterine Positioning System™.
37340 • Rev. B • 9/11
Lassen Sie alle omponenten nach der Dampfsterilisation auf
Raumtemperatur abkühlen. Plötzliche Temperaturveränderungen
können die omponenten beschädigen.
,09(,5Die auf der vorhergehenden Seite aufgeführten Parameter
sind lediglich Empfehlungen. Für die Sterilität des Geräts ist das
rankenhaus oder die Stelle, die die Sterilisation durchführt,
verantwortlich. (Nähere Einzelheiten zum Sterilisationssystem sind
dem Handbuch des Herstellers des Sterilisationsgeräts zu entnehmen.)
Bei der Entsorgung sind alle staatlichen, regionalen und lokalen
Vorschriften zur Entsorgung von medizinischen/gefährlichen Abfällen
zu beachten.
Laut US-Bundesgesetz ist der
Verkauf dieses Produkts nur an Ärzte oder im
Auftrag von Ärzten erlaubt.
Nachbestellnummer
Chargencode
!
"
!
Latexfrei
Siehe
Gebrauchsanleitung.
!"
Autorisierte Vertretung in der
Europäischen Gemeinschaft.
Produkt entspricht der Medizinprodukterichtlinie
93/42/EEG
95 Corporate Drive
Trumbull, CT 06611 USA
Tel: +1 (800) 243-2974
Fax: +1 (800) 262-0105
www.coopersurgical.com
37340 • Rev. B • 9/11
Leisegang Feinmechanik GmbH
Leibnizstraße 32
D-10625, Berlin GERMANY
International
Tel: +1 (203) 601-9818
Fax: +1 (203) 601-4747
Hergestellt in USA
Hergestellt für:
'$26$'14'8,0&7.$4&+
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4. Cierre y bloquee el pestillo; asegúrese de que el asa de
manipulación esté firmemente unida al adaptador y no pueda
moverse libremente.
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S: al bloquear el pestillo, tenga especial cuidado de
evitar cualquier contacto con la paciente o con otros accesorios del
campo quirúrgico.
Para separar el asa de manipulación, desbloquee y abra el pestillo
del adaptador mientras sostiene el asa de manipulación y sepárela
del adaptador.
16$ no es necesario pisar el pedal y mover el brazo del UPS para
separar del adaptador el asa de manipulación.
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Para extraer del UPS el adaptador del brazo una vez concluida la
cirugía, presione el botón de liberación del brazo (consulte la Figura 3)
y tire hacia afuera del adaptador, en línea recta y sin girarlo.
#
1. Prepare el detergente enzimático según las recomendaciones del
fabricante y sumerja el adaptador en el detergente. Remoje durante
diez (10) minutos.
2. Restriegue el adaptador sumergido con una esponja o cepillo
suaves y agítelo. Limpie las hendiduras con un limpiapipas/cepillo o
mediante una jeringa cuando resulte adecuado. Accione todas las
piezas móviles para que se aflojen los residuos incrustados.
3. Aclare con agua tibia del grifo a 38-49 °C (100-120 °F) durante
un (1) minuto. Enjuague a fondo las zonas de difícil acceso.
Accione las piezas móviles mientras aclara.
4. Coloque el adaptador en un recipiente con agua templada (38-49 °C,
100-120 °F). Agite el adaptador a mano durante al menos un
(1) minuto. Repita este proceso dos (2) veces más.
5. Limpie el adaptador con ultrasonidos durante veinte (20) minutos
en un detergente de pH neutro (Neutrad®u otro aceptable).
Prepare el detergente de acuerdo con las recomendaciones
del fabricante.
6. Aclare el adaptador con agua limpia del grifo durante un (1) minuto
a la vez que acciona las piezas móviles; repita el aclarado
dos veces.
7. Seque el adaptador a fondo con un paño limpio y sin pelusas.
8. Repita este procedimiento de limpieza si el adaptador parece
seguir teniendo residuos después de la limpieza inicial y hasta que
no queden trazas de residuos en el dispositivo.
P#S
,&.1'(24(8$&F1
Pulsos de preacondicionamiento: 4
Temperatura de exposición: 132-134 °C (270-273 °F)
Tiempo de exposición: 4 minutos
,&.15'('(52.$<$/,(061214*4$8('$'
Temperatura de exposición: 132-135 °C (270-275 °F)
Tiempo de exposición: 15 minutos
Temperatura de exposición: 121-123 °C (250-253 °F)
Tiempo de exposición: 40 minutos
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Patilla de
acoplamiento
Asa Advincula Arch Adaptador
Advincula
Arch
Orificio de
acoplamiento
Botón de liberación
Brazo
Asa del UPS
Pestillo
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Deben realizarse los pasos siguientes antes de conectar el adaptador
al brazo del UPS™:
1. Paciente colocada, preparada y con el asa de manipulación insertada.
2. Brazo del UPS y paciente correctamente cubiertos.
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1. Alinee el agujero perforado reforzado de la cubierta estéril del UPS
con el Orificio de Acoplamiento del brazo del UPS.
2. Inserte la patilla de Acoplamiento del adaptador (consulte la
Figura 1) en el orificio de acoplamiento del brazo del UPS hasta que
quede firmemente asentada. Utilice la patilla de alineación para
orientar correctamente el adaptador.
3. Asegúrese de que el adaptador quede firme en su sitio sobre
el brazo.
06(5'(&10(&6$4(.$5$'(/$0,27.$&,G0
Deben realizarse los pasos siguientes antes de conectar el asa de
manipulación al adaptador:
1. Paciente colocada para cirugía.
2. Brazo del UPS cubierto y adaptador colocados en una posición
cercana para conectar el extremo proximal del asa de manipulación.
10(:,G0'(.$5$'(/$0,27.$&,G0
SNO conecte el asa de manipulación al brazo del UPS
hasta que la paciente esté en la posición final y sedada.
1. Abra el pestillo del adaptador (consulte la Figura 2).
S&10(.),0'((8,6$4(./18,/,(061,0$'8(46,'1'(.
$5$'(/$0,27.$&,G05156(0*$),4/(/(06((.$5$'(.$06(5
'(2,5$4(.2('$.
16$ con el fin de conseguir un movimiento óptimo, utilice únicamente
el asa del UPS para mover el dispositivo.
2. Agarre el asa del UPS, pise el pedal y mueva el brazo para alinear
el adaptador con el asa de manipulación. Tome precauciones para
reducir al mínimo el movimiento del asa de manipulación dentro de
la paciente.
3. Coloque la patilla de acoplamiento del adaptador en el orificio de
acoplamiento del asa de manipulación.
Patilla de alineación
Patilla de
acoplamiento
Orificio de
acoplamiento
Pestillo
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Instrucciones de uso (Español / Spanish)
S las leyes federales
de EE UU limitan la venta de este
dispositivo a médicos o por
prescripción médica.
>
R
"
• El hecho de no seguir correctamente las instrucciones del adaptador
Advincula Arch (adaptador), incluidas las instrucciones suministradas
con el sistema de posicionamiento uterino (UPS, 371550-03) y el asa
de manipulación uterina Advincula Arch (asa de manipulación,
UMH750), puede provocar lesiones y dar lugar a un funcionamiento
incorrecto del sistema.
• El adaptador está diseñado exclusivamente para su uso con el asa
de manipulación Advincula Arch y el UPS. No se recomienda el uso
de este dispositivo con ningún otro instrumento de manipulación, ya
que podría provocar lesiones y dar lugar a un funcionamiento
incorrecto del dispositivo.
• Los procedimientos quirúrgicos que requieren instrumentos
vaginales no son estériles. Al utilizar el UPS, deben observarse
los procedimientos de quirófano convencionales para mantener
la esterilidad.
• El adaptador se suministra sin esterilizar; debe limpiarse y
esterilizarse antes de su uso.
• Verifique que esté utilizando el adaptador correcto con el asa
de manipulación.
• Consulte las instrucciones de uso del UPS para obtener
más instrucciones.
• Tenga SIEMPRE correctamente colocadas a la paciente y la mesa de
operaciones antes de conectar el UPS al asa de manipulación.
• Suministre SIEMPRE a la paciente una anestesia endotraqueal
general al conectar el UPS al asa de manipulación.
Consulte las instrucciones de uso del asa de manipulación (UMH750)
para conocer las contraindicaciones correspondientes del dispositivo.
S
Las leyes federales de EE UU limitan la venta de este dispositivo a
médicos o por prescripción médica.
Neutrad®es una marca comercial registrada de Decon Labs, Inc.
CooperSurgical es una marca comercial registrada de CooperSurgical, Inc.
El resto de marcas con los símbolos TM y ® son marcas comerciales y
marcas comerciales registradas de CooperSurgical, Inc.
© 2011 CooperSurgical, Inc. Todos los derechos reservados.
S
El adaptador Advincula Arch™es un dispositivo reutilizable que se
usa exclusivamente para conectar el asa de manipulación uterina
Advincula Arch al Uterine Positioning System™.
37340 • Rev. B • 9/11
Tras la esterilización con vapor, deje que todos los componentes se
enfríen hasta la temperatura ambiente. Los cambios repentinos de
temperatura pueden dañar los componentes.
16$los parámetros indicados en la página anterior constituyen
únicamente una recomendación. La esterilidad del dispositivo es
responsabilidad del hospital o emplazamiento en el que se efectúe la
esterilización. (Consulte el manual del fabricante del esterilizador para
obtener detalles sobre la unidad de esterilización.)
S
Deseche de acuerdo con todas las prácticas federales, estatales y
locales aplicables sobre residuos médicos/peligrosos.
Slas leyes federales de EE UU
limitan la venta de este dispositivo a médicos o
por prescripción médica.
Número de pedido
Código de lote
!
!SR
!
Sin látex
S consultar las instrucciones de uso.
!"
Representante autorizado en la
Comunidad Europea.
El producto cumple con la directiva sobre dispositivos
médicos 93/42/CEE
95 Corporate Drive
Trumbull, CT 06611 USA
Teléfono: +1 (800) 243-2974
Fax: +1 (800) 262-0105
www.coopersurgical.com
37340 • Rev. B • 9/11
Leisegang Feinmechanik GmbH
Leibnizstraße 32
D-10625, Berlin GERMANY
Internacional
Teléfono: +1 (203) 601-9818
Fax: +1 (203) 601-4747
Fabricado en EE UU
Fabricado para:
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4. Fermer et verrouiller le loquet, puis vérifier que la poignée pour
manipulateur est bien fixée sur l’adaptateur, sans jeu.
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: En verrouillant le loquet, veiller à éviter tout contact avec
la patiente ou d’autres accessoires dans le champ stérile.
Pour détacher la poignée pour manipulateur, déverrouiller et ouvrir le
loquet sur l’adaptateur en tenant la poignée pour manipulateur et la
séparer de l’adaptateur.
(/$437( Il n'est pas nécessaire d'appuyer sur la pédale ni de
déplacer le bras de l'UPS pour séparer la poignée pour manipulateur
de l’adaptateur.
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Pour détacher l’adaptateur du bras de l’UPS une fois l’intervention
terminée, appuyer sur le bouton de libération situé sur le bras
(voir la Figure 3) et tirer l’adaptateur tout droit sans le tourner.
">
1. Préparer le détergent enzymatique selon les recommandations du
fabricant et immerger l’adaptateur dans le détergent. Laisser
tremper pendant dix (10) minutes.
2. Frotter l’adaptateur immergé avec une éponge non abrasive ou
une brosse souple et agiter. Nettoyer les creux en utilisant un
cure-pipe/une brosse ou rincer avec une seringue selon les
besoins. Actionner toutes les pièces mobiles pour éliminer les
souillures incrustées.
3. Rincer à l’eau tiède du robinet à une température comprise entre
38 à 49 °C (100 à 120 °F) pendant une (1) minute. Rincer
soigneusement les zones difficiles d’accès. Actionner au cours du
rinçage.
4. Placer l’adaptateur dans un bain d’eau tiède (38 à 49 °C,
100 à 120 °F). Agiter l’adaptateur à la main pendant au moins
une (1) minute. Répéter ce processus deux (2) fois de plus.
5. Nettoyer l’adaptateur aux ultrasons pendant vingt (20) minutes
dans un détergent à pH neutre (Neutrad®ou un autre produit
acceptable). Préparer le détergent selon les recommandations
du fabricant.
6. Rincer l’adaptateur à l’eau claire du robinet, en actionnant les
pièces mobiles pendant le rinçage, pendant une (1) minute ;
répéter deux fois le rinçage.
7. Sécher soigneusement l’adaptateur avec un linge non
pelucheux propre.
8. Répéter cette procédure de nettoyage si l’adaptateur est
visiblement souillé après le nettoyage initial, et jusqu’à ce qu’il ne
reste plus aucune trace de souillure sur le dispositif.
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Impulsions de pré-conditionnement : 4
Température d’exposition : 132 à 134 °C (270 à 273 °F)
Durée d’exposition : 4 minutes
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Température d’exposition : 132 à 135 °C (270 à 275 °F)
Durée d’exposition : 15 minutes
Température d’exposition : 121 à 123 °C (250 à 253 °F)
Durée d’exposition : 40 minutes
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Broche
correspondante
Poignée Advincula Arch Adaptateur
Advincula
Arch
Trou correspondant
Bouton de libération
Bras
Poignée de l’UPS
Loquet
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Les étapes suivantes doivent être accomplies avant de fixer
l’adaptateur au bras de l’UPS™:
1. Positionner et préparer la patiente puis introduire la poignée
pour manipulateur.
2. Placer les champs opératoires sur le bras de l’UPS et la patiente.
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1. Aligner le trou perforé renforcé du champ stérile de l’UPS sur le trou
correspondant du bras de l’UPS.
2. Insérer à fond la broche d’engagement de l’adaptateur (voir la
Figure 1) dans le trou correspondant du bras de l’UPS. Utiliser la
broche d’alignement pour orienter correctement l’adaptateur.
3. Vérifier que l’adaptateur est bien en place sur le bras.
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Les étapes suivantes doivent être accomplies avant de fixer la
poignée pour manipulateur à l’adaptateur :
1. Positionner la patiente pour la chirurgie.
2. Placer le bras de l’UPS et l’adaptateur recouverts de champs en
position approximative pour leur fixation près de l’extrémité
proximale de la poignée pour manipulateur.
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NE PAS fixer la poignée pour manipulateur au bras
de l’UPS avant que la patiente ne soit en position finale et
sous anesthésie.
1. Ouvrir le loquet sur l’adaptateur (voir la Figure 2).
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(/$437( Pour un mouvement optimal, saisir uniquement la
poignée de l’UPS pour déplacer le dispositif.
2. Saisir la poignée de l’UPS, appuyer sur la pédale et déplacer le
bras pour aligner l’adaptateur sur la poignée pour manipulateur.
Veiller à réduire au minimum le mouvement de la poignée pour
manipulateur à l’intérieur du corps de la patiente.
3. Positionner la broche correspondante sur l’adaptateur dans le trou
correspondant sur la poignée pour manipulateur.
Broche d’alignement
Broche
d’engagement
Trou correspondant
Loquet
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Mode d’emploi (Français / French)
>
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>
• La non-observation des instructions pour l’adaptateur Advincula Arch
(adaptateur), y compris des instructions fournies avec le système de
positionnement utérin (UPS, 371550-03) et la poignée pour
manipulateur utérin Advincula Arch (poignée pour manipulateur,
UMH750), risque d’entraîner des lésions et un mauvais
fonctionnement du système.
• L’adaptateur est prévu pour être utilisé uniquement avec la poignée
pour manipulateur Advincula Arch et l’UPS. L’utilisation de ce
dispositif avec un autre manipulateur n’est pas recommandée, et
risque d’entraîner des lésions et un mauvais fonctionnement
du dispositif.
• Les interventions chirurgicales nécessitant une instrumentation
vaginale ne sont pas stériles. Il convient d’observer les procédures
conventionnelles de stérilité applicables aux salles d’opération quand
l’UPS est utilisé.
• L’adaptateur est fourni non stérile et doit être nettoyé et stérilisé
avant l’utilisation.
• Vérifier que l’adaptateur correct est utilisé avec la poignée
pour manipulateur.
• Se reporter au mode d’emploi de l’UPS pour des instructions supplémentaires.
• TOUJOURS positionner la patiente et la table de la salle d’opération
avant de fixer l’UPS à la poignée pour manipulateur.
• TOUJOURS administrer une anesthésie endotrachéale générale à la
patiente quand l’UPS est fixé à la poignée pour manipulateur.
Se reporter au mode d’emploi de la poignée pour manipulateur
(UMH750) pour les contre-indications applicables au dispositif.
Selon la loi fédérale américaine, ce produit ne peut être vendu que par
un médecin ou sur son ordonnance.
Neutrad®est une marque déposée de Decon Labs, Inc.
CooperSurgical est une marque déposée de CooperSurgical, Inc.
Toutes les autres marques avec les symboles TM et ® sont des marques
de commerce et des marques déposées de CooperSurgical, Inc.
© 2011 CooperSurgical, Inc. Tous droits réservés.
L’adaptateur Advincula Arch™est un dispositif réutilisable qui
sert exclusivement à fixer la poignée pour manipulateur utérin
Advincula Arch au système de positionnement utérin (Uterine
Positioning System™).
37340 • Rév. B • 9/11
Après la stérilisation à la vapeur, laisser tous les composants refroidir à
la température ambiante. Les changements de température soudains
risquent d’endommager les composants.
(/$437(Les paramètres de la page précédente sont donnés
uniquement à titre de recommandation. La stérilité du dispositif est la
responsabilité de l’hôpital ou du centre qui effectue la stérilisation.
(Se reporter au manuel du fabricant du stérilisateur pour des détails
concernant l’appareil de stérilisation.)
>
Éliminer conformément aux pratiques en vigueur au niveau fédéral,
local et de l’état concernant la mise au rebut des déchets médicaux à
risque biologique.
Selon la loi fédérale américaine, ce
produit ne peut être vendu que par un médecin ou
sur son ordonnance.
Numéro de référence
Code de lot
!
!"
!
Sans latex
Consulter le mode d’emploi.
!"
Représentant agréé au sein de la
Communauté européenne.
Produit conforme à la directive 93/42/CEE relative aux
dispositifs médicaux
95 Corporate Drive
Trumbull, CT 06611 USA
Téléphone : +1 (800) 243-2974
Fax : +1 (800) 262-0105
www.coopersurgical.com
37340 • Rév. B • 9/11
Leisegang Feinmechanik GmbH
Leibnizstraße 32
D-10625, Berlin GERMANY
International
Téléphone : +1 (203) 601-9818
Fax : +1 (203) 601-4747
Fabriqué aux États-Unis
Fabriqué pour :
Selon la loi fédérale
américaine, ce produit ne peut être
vendu que par un médecin ou sur
son ordonnance.
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4. Chiudere e bloccare la serratura a scatto e assicurarsi che
l’impugnatura per manipolatore sia saldamente attaccata
all’adattatore e che non possa muoversi liberamente.
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#: nel bloccare la serratura a scatto, fare attenzione
a evitare il contatto con la paziente o con altri accessori nel
campo chirurgico.
Per staccare l’impugnatura per manipolatore, sbloccare e aprire la
serratura a scatto sull’adattatore, tenendo contemporaneamente
l’impugnatura, e allontanarla dall’adattatore.
16$ per staccare l’impugnatura per manipolatore dall’adattatore non
occorre schiacciare la leva a pedale e spostare il braccio dell’UPS.
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Per staccare l’adattatore dal braccio dell’UPS al termine dell’intervento
chirurgico, premere il pulsante di rilascio sul braccio (fare riferimento
alla Figura 3) spingendo l’adattatore senza esitazioni e senza ruotare.
#
1. Preparare il detergente enzimatico come raccomandato dal
produttore e immergervi l’adattatore. Tenere in immersione per
dieci (10) minuti.
2. Sfregare con una spugna morbida o con una spazzola l’adattatore
tenuto in immersione e agitare. Pulire le fessure, usando una
spazzola o uno scovolino o, se del caso, irrorare con una siringa.
Movimentare ogni parte mobile per distaccare lo sporco intrappolato.
3. Risciacquare per un (1) minuto con acqua del rubinetto calda
(38 °C - 49 °C 100 - 120 °F). Irrorare a fondo le zone difficili da
raggiungere. Movimentare mentre si risciacqua.
4. Immergere l’adattatore in acqua calda (38 °C - 49 °C 100 - 120 °F).
Agitare a mano l’adattatore per almeno un (1) minuto. Ripetere
questa procedura altre due (2) volte.
5. Pulire l’adattatore con gli ultrasuoni per venti (20) minuti in un
detergente a pH neutro (Neutrad®o un altro accettabile). Preparare
il detergente come raccomandato dal produttore.
6. Risciacquare per un (1) minuto l’adattatore con acqua del rubinetto
pulita, azionando le parti mobili mentre si risciacqua; ripetere il
risciacquo altre due volte.
7. Asciugare bene l’adattatore con un panno pulito senza fili.
8. Ripetere questa procedura in caso l’adattatore sembri sporco
dopo la pulizia iniziale e finché non vi siano più segni di sporco
sul dispositivo.
###
,&.1',24(87161
Impulsi di precondizionamento: 4
Temperatura di esposizione: 132 °C - 134 °C (270 - 273 °F)
Tempo di esposizione: 4 minuti
,&.,',(.,/,0$<,10('(..$*4$8,6@
Temperatura di esposizione: 132 °C -135 °C (270 - 275 °F)
Tempo di esposizione: 15 minuti
Temperatura di esposizione: 121 °C - 123 °C (250 - 253 °F)
Tempo di esposizione: 40 minuti
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Spinotto di
accoppiamento
Impugnatura
Advincula Arch
Foro di
accoppiamento
Pulsante di rilascio
Braccio
Impugnatura dell’UPS
Serratura a scatto
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Prima di attaccare l’adattatore al braccio del sistema UPS™si devono
completare i seguenti passaggi:
1. La paziente è in posizione, preparata e l’impugnatura per
manipolatore è inserita.
2. Il braccio dell’UPS e la paziente sono adeguatamente coperti dal
telo chirurgico.
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1. Allineare il foro punzonato rinforzato del telo sterile dell’UPS con il
foro di accoppiamento nel braccio dell’UPS.
2. Inserire lo spinotto di bloccaggio dell’adattatore (fare riferimento alla
Figura 1) nel foro di accoppiamento del braccio dell’UPS fino a
fissarlo saldamente. Usare lo spinotto di allineamento per orientare
correttamente l’adattatore.
3. Assicurarsi che l’adattatore sia saldamente bloccato in posizione
sul braccio.
4,/$'(..N$66$&&1'(..N,/27*0$674$2(4/$0,21.$614(
Prima di collegare l’impugnatura per manipolatore all’adattatore si
devono completare i seguenti passaggi:
1. La paziente è in posizione per l’intervento chirurgico.
2. Il braccio ricoperto dell’UPS e l’adattatore vengono accostati l’uno
all’altro per l’attacco vicino all’estremità prossimale dell’impugnatura
per manipolatore.
66$&&1'(..N,/27*0$674$2(4/$0,21.$614(
#NON attaccare l’impugnatura per manipolatore al
braccio dell’UPS finché la paziente non sia nella posizione finale
e sedata.
1. Aprire la serratura a scatto sull’adattatore (fare riferimento alla Figura 2).
#24,/$',24(/(4(.$.(8$$2('$.(6(0(4(,0/1'1
5$.'1.N,/27*0$674$'(..N2(4(8,6$4(',/718(4(
,0$88(46,6$/(06(.N,/27*0$674$2(4/$0,21.$614(
16$ al fine di avere un movimento ottimale, per spostare il dispositivo
afferrare solo l’impugnatura dell’UPS.
2. Tenere bene l’impugnatura dell’UPS, premere la leva a pedale e
spostare il braccio per allineare l’adattatore con l’impugnatura per
manipolatore. Fare attenzione a ridurre al minimo il movimento
dell’impugnatura per manipolatore all’interno della paziente.
3. Posizionare lo spinotto di accoppiamento sull’adattatore dentro il
foro di accoppiamento dell’impugnatura per manipolatore.
Spinotto di
allineamento
Spinotto di
bloccaggio
Foro di
accoppiamento
Serratura a
scatto
,56$)4106$.( ,56$2156(4,14(
Adattatore
Advincula Arch
'$66$614('8,0&7.$4&+J
'$75$4(&10'8,0&7.$4&+
Istruzioni per l’uso (Italiano / Italian)
# la legge federale
statunitense limita la vendita di
questo dispositivo ai medici o su
presentazione di prescrizione medica.
##N
##
• La mancata osservanza delle istruzioni per l’adattatore Advincula
Arch, comprese quelle fornite per il sistema “Uterine Positioning
System” (UPS, 371550-03) e per l’impugnatura per manipolatore
uterino Advincula Arch (UMH750), potrebbe causare danni
comportando un funzionamento anomalo del sistema.
• L’adattatore è ideato unicamente per l’uso con l’impugnatura per
manipolatore Advincula Arch e il sistema UPS. Si sconsiglia l’utilizzo
di questo dispositivo con qualunque altro manipolatore per evitare
danni e un funzionamento non corretto del dispositivo.
• Le procedure chirurgiche che richiedono strumentazione vaginale
non sono condotte in sterilità. Quando si utilizza l’UPS si devono
osservare le normali procedure praticate in sala operatoria finalizzate
a preservare un ambiente asettico.
• L’adattatore viene fornito in condizioni non sterili e va pulito e
sterilizzato prima dell’uso.
• Verificare di selezionare l’adattatore corretto da usare per
l’impugnatura del manipolatore.
• Per ulteriori indicazioni, consultare le Istruzioni per l’uso del
sistema UPS.
• Prima di attaccare l’UPS all’impugnatura per manipolatore
RICORDARSI SEMPRE di posizionare la paziente e il
tavolo operatorio.
• RICORDARSI che la paziente deve SEMPRE essere sotto anestesia
generale endotracheale quando l’UPS è attaccato all’impugnatura
per manipolatore.
#
Per le controindicazioni relative al dispositivo, consultare le istruzioni
per l’uso dell’impugnatura per manipolatore (UMH750).
#
La legge federale statunitense limita la vendita di questo dispositivo ai
medici o su presentazione di prescrizione medica.
Neutrad®è un marchio depositato di Decon Labs, Inc.
CooperSurgical è un marchio depositato di CooperSurgical, Inc.
Tutti gli altri marchi recanti i simboli “TM” e “®” sono marchi commerciali e
marchi commerciali depositati di CooperSurgical, Inc.
© 2011 CooperSurgical, Inc. Tutti i diritti riservati.
#
L’adattatore Advincula Arch™è un dispositivo riutilizzabile impiegato
per unire l’impugnatura per manipolatore uterino Advincula Arch
esclusivamente all’Uterine Positioning System™.
37340 • Rev. B • 9/11
Dopo la sterilizzazione a vapore lasciare che tutti i componenti si
raffreddino fino a temperatura ambiente. Variazioni di temperatura
improvvise possono danneggiare i componenti.
16$i parametri elencati nella pagina precedente sono solo
consigliati. La sterilità del dispositivo ricade sotto la responsabilità
dell’ospedale o della struttura che effettua la sterilizzazione. (Per i
dettagli circa l’unità di sterilizzazione fare riferimento al manuale del
produttore dello sterilizzatore.)
Smaltire in conformità alle normative sui rifiuti sanitari/pericolosi locali,
regionali e statali di pertinenza.
95 Corporate Drive
Trumbull, CT 06611 USA
Tel: +1 (800) 243-2974
Fax: +1 (800) 262-0105
www.coopersurgical.com
37340 • Rev. B • 9/11
Leisegang Feinmechanik GmbH
Leibnizstraße 32
D-10625, Berlin GERMANY
Internazionale
Tel: +1 (203) 601-9818
Fax: +1 (203) 601-4747
#M
La legge federale statunitense
limita la vendita di questo dispositivo ai medici o
su presentazione di prescrizione medica.
Numero di riordine
Codice del lotto
!
#
!
Non contiene lattice
#MVedere le istruzioni per l’uso.
!"
Rappresentante autorizzato per la
Comunità Europea.
Questo prodotto è conforme ai requisiti della Direttiva
93/42/CEE concernente i dispositivi medici
Fabbricato negli USA
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