PT

EN
DE
FR
IT
ES
Instructions for Use

INTENDED USE:
KeyHole Cup is intended as a laparoscopic access assist device. It is
intended to raise the abdominal wall above critical organs and vessels by
means of negative pressure, thus creating an initial pneumoperitoneum prior
to laparoscopic access.

INSTRUCTIONS FOR USE:
1. Remove the KeyHole Cup from the sterile packaging and place into the
sterile field.
2. Prepare the patients skin surface per standard practice and position
the KeyHole Cup over the area for intended access.
3. Connect an external vacuum system onto the KeyHole Cups suction
port using appropriate tubing.
4. Check for secure attachment between the suction port and the vacuum
tubing using gentle pulls.
5. Engage the vacuum system to provide negative pressure sufficient to
lift the patients skin into an elevated domed position creating an initial
pneumoperitoneum.
NOTE: Keep the Cup as firmly as possible against the patients skin
during this step to ensure adequate suction is achieved.
WARNING: Do not exceed 15 barr negative pressure.
6. Insert a Veress needle through the KeyHole Cups central insertion
port.
7. Determine that the Veress needle has been inserted to the desired
depth and proceed with insufflation per standard technique.
8. Gradually release the negative pressure until the initial
pneumoperitonum has been adequately insufflated.
9. Once desired insufflation has been achieved, remove the Veress
needle.
10. Turn off the vacuum system and remove KeyHole Cup from skin.

CONTRA-INDICATIONS:
To minimise risk to patient and foetus, the KeyHole Cup device should not be
used on patients who are pregnant.

CAUTION:
The KeyHole Cup should be inspected prior to use for damage or breakage.

STORAGE:
Handle with care. The KeyHole Cup should be stored under conditions that
protect it from extremes of temperature and humidity.

EN
VERWENDUNGSZWECK:
Die KeyHole-Tasse ist als Hilfsvorrichtung fr den laparoskopischen Zugang vorgesehen. Sie soll
die Bauchdecke oberhalb kritischer Organe und Gefe durch Unterdruck anheben, umvor dem
laparoskopischenZugang ein anfngliches Pneumoperitoneumzu schaffen.
GEBRAUCHSANWEISUNG:
1. Entnehmen Sie die anfngliche KeyHole-Tasse aus der sterilen Verpackung und legen
Sie sie in den sterilen Bereich.
2. Bereiten Sie die Hautoberflche des Patienten mithilfe des Standardverfahrens vor und
positionieren Sie die KeyHole-Tasse ber demfr den Zugang bestimmten Bereich.
3. Schlieen Sie an den Sauganschluss der KeyHole-Tasse ein externes Vakuumsystem
mit passendemSchlauch an.
4. berprfen Sie durch vorsichtiges Ziehen die sichere Verbindung zwischen der
Ansaugffnung undder Vakuumrhre.
5. Aktivieren Sie das Vakuumsystem, umeinen negativen Druck herzustellen, der
ausreicht, umdie Haut des Patienten in eine erhhte gewlbte Position anzuheben und
ein anfngliches Pneumoperitoneumzu schaffen.
HINWEIS: Halten Sie die Tasse whrend dieses Schritts so fest wie mglich gegen die
Haut des Patienten, umeine ausreichende Saugleistung zu erreichen.
WARNUNG: Nicht mehr als 15 bar Unterdruck anwenden.
6. Punktieren Sie eine Veress-Nadel durch die zentrale Einfhrungsffnung der Keyhole-
Tasse.
7. Vergewissern Sie sich, dass die Veress-Nadel bis zur gewnschtenTiefe eingefhrt
wurde und fahren Sie mithilfe der Standardtechnik mit der Insufflation fort.
8. Lassen Sie die negativen Druck fortlaufend ab, bis das ursprngliche
Pneumoperitoneumausreichend insuffliert wurde.
9. Sobald die gewnschte Insufflation erreicht wurde, entfernen Sie bitte die Veress-Nadel.
10. Schalten Sie das Vakuumsystemab und entfernen Sie die KeyHole-Tasse von der Haut.
GEGENANZEIGEN:
Umdie Risiken fr Patienten und Ftus zu minimieren, sollte die KeyHole-Tasse nicht bei
schwangeren Patienteneingesetzt werden.
VORSICHT:
Die KeyHole-Tasse sollte vor einer Verwendung auf Beschdigung oder Bruch geprft werden.
LAGERUNG:
Mit Vorsicht handhaben. Die KeyHole-Tasse sollte unter Bedingungen gelagert werden, bei denen
sie vor Hitze, Klte und Feuchtigkeit geschtzt ist.
DE

USO PREVISTO:
KeyHole Cup es un dispositivo de asistencia para el acceso laparoscpico.
Se ha diseado para elevar la pared abdominal por encima de los rganos
vitales y vasos sanguneos mediante presin negativa, por lo que crea un
neumoperitoneo inicial previo al acceso laparoscpico.

INSTRUCCIONES DE USO:
1. Saque el KeyHole Cup del embalaje estril y colquelo sobre el campo
estril.
2. Prepare la superficie cutnea del paciente segn procedimiento
estndar y coloque el KeyHole Cup sobre el rea a la que se pretende
acceder.
3. Conecte un sistema de vaco externo al puerto de succin del KeyHole
Cup utilizando un tubo adecuado.
4. Compruebe con unos tirones suaves que la sujecin entre el puerto de
succin y el tubo de vaco es segura.
5. Conecte el sistema de vaco de forma que suministre suficiente
presin negativa como para elevar la piel del paciente a una posicin
convexa elevada creando un neumoperitoneo inicial.
NOTA: Mantenga el KeyHole Cup sujeto a la piel del paciente lo ms
firmemente que pueda durante este paso para garantizar que se logra
la succin adecuada.
ADVERTENCIA: No supere la presin negativa de 15 bares.
6. Introduzca una aguja de Veress a travs del puerto de insercin
central del KeyHole Cup.
7. Verifique que la aguja de Veress se ha introducido hasta la
profundidad deseada y proceda con la insuflacin, segn tcnica
estndar.
8. Libere gradualmente la presin negativa hasta que se haya insuflado
adecuadamente el neumoperitoneo inicial.
9. Una vez obtenida la insuflacin deseada, retire la aguja de Veress.
10. Apague el sistema de vaco y separe el KeyHole Cup de la piel.

CONTRAINDICACIONES:
El dispositivo KeyHole Cup no debera utilizarse en pacientes embarazadas a
fin de minimizar los riesgos para el paciente y para el feto.

ATENCIN:
Antes de utilizar el KeyHole Cup inspeccinelo para descartar daos o
roturas.

ALMACENAMIENTO:
Maniplelo con cuidado. El KeyHole Cup debe almacenarse en condiciones
que lo protejan de las temperaturas extremas y de la humedad.

ES






DOMAINE D'APPLICATION :
KeyHole Cup est un dispositif d'aide l'accs laparoscopique. Son rle
consiste de soulever la paroi abdominale au-dessus des organes et des
vaisseaux critiques par l'application d'une pression ngative et la cration
d'un pneumopritoine avant l'accs laparoscopique.

MODE D'EMPLOI :
1. Retirer KeyHole Cup de son emballage strile et le placer sur le champ
strile.
2. Prparer la surface cutane du patient suivant les pratiques habituelles
et positionner KeyHole Cup sur la zone laquelle on souhaite accder.
3. Connecter un systme de production de vide externe au port
d'aspiration de KeyHole Cup l'aide d'un tuyau appropri.
4. Vrifier la bonne fixation du tuyau de vide au port d'aspiration en tirant
lgrement dessus.
5. Mettre en marche le systme de production de vide afin de fournir une
pression ngative suffisante pour soulever la peau du patient en forme
de dme et crer un pneumopritoine initial.
REMARQUE : Maintenir KeyHole Cup le plus fermement possible
contre la peau du patient pendant cette tape afin de garantir une
bonne aspiration.
ATTENTION : Ne pas dpasser une pression ngative de 15 bars.
6. Insrer une aiguille de Veress travers le port d'insertion central de
KeyHole Cup.
7. Vrifier la profondeur d'insertion de l'aiguille de Veress et procder
l'insufflation suivant la technique habituelle.
8. Rduire progressivement la pression ngative jusqu' l'insufflation
adquate du pneumopritoine initial.
9. Une fois l'insufflation dsire obtenue, retirer l'aiguille de Veress.
10. teindre le systme de production de vide et retirer KeyHole Cup de la
zone cutane.

CONTRE-INDICATIONS :
Afin de minimiser les risques chez la patiente et le foetus, le dispositif
KeyHole Cup ne doit pas tre utilis chez les femmes enceintes.

ATTENTION :
Avant l'utilisation, vrifier l'absence de dommage ou fissure sur KeyHole Cup.

ENTREPOSAGE :
Manipuler avec soin. KeyHole Cup doit tre entrepos l'cart de toute
condition extrme de temprature et humidit.
FR




USO PREVISTO
KeyHole Cup un dispositivo di assistenza per laccesso laparoscopico.
progettato per sollevare la parete addominale sopra gli organi critici e i vasi
sanguigni per mezzo di pressione negativa, creando cos uno
pneumoperitoneo iniziale prima dellaccesso laparoscopico.

ISTRUZIONI PER LUSO:
1. Rimuovere KeyHole Cup dalla confezione sterile e posizionarlo sul
campo sterile.
2. Preparare la superficie cutanea del paziente seguendo la prassi
standard e posizionare KeyHole Cup sullarea a cui si intende
accedere.
3. Collegare un sistema esterno di aspirazione alla bocchetta di
aspirazione di KeyHole Cup usando un tubo appropriato.
4. Tirando delicatamente, verificare che il collegamento tra la bocchetta di
aspirazione e il tubo di aspirazione sia saldo.
5. Avviare il sistema di aspirazione in modo che eroghi una pressione
negativa sufficiente a sollevare la cute del paziente creando una
conformazione a cupola e dando origine a uno pneumoperitoneo
iniziale.
NOTA: durante questa fase, tenere il dispositivo il pi saldamente
possibile contro la cute del paziente per garantire il raggiungimento di
unaspirazione adeguata.
ATTENZIONE: non superare i 15 bar di pressione negativa.
6. Inserire un ago di Veress nellingresso centrale di KeyHole Cup.
7. Verificare che lago di Veress sia inserito fino alla profondit desiderata
e procedere allinsufflazione secondo la tecnica standard.
8. Diminuire gradualmente la pressione negativa finch lo
pneumoperitoneo iniziale non stato adeguatamente insufflato.
9. Dopo aver raggiunto il grado di insufflazione desiderato, rimuovere
lago di Veress.
10. Spegnere il sistema di aspirazione e rimuovere KeyHole Cup dalla
superficie cutanea.

CONTROINDICAZIONI:
Per ridurre al minimo il rischio per la paziente e per il feto, KeyHole Cup non
deve usato su pazienti in gravidanza.

ATTENZIONE:
KeyHole Cup deve essere controllato prima delluso per verificare che non
presenti danni o rotture.

CONSERVAZIONE:
IT
Maneggiare con cura. KeyHole Cup deve essere conservato al riparo di
condizioni estreme di temperatura e umidit.







UTILIZAO:
O KeyHole Cup foi concebido como um dispositivo para acesso
laparoscpico assistido. Tem como funo a de levantar a parede
abdominal acima dos rgos-alvo e dos vasos sanguneos atravs de
presso negativa, criando um pneumoperitoneu inicial, anterior ao acesso
laparoscpico.

MODO DE UTILIZAO:
1. Retirar o KeyHole Cup da embalagem esterilizada e coloc-lo na rea
esterilizada.
2. Preparar a superfcie da pele do paciente para os procedimentos-
padro e para o posicionamento do KeyHole Cup na rea
seleccionada para o acesso.
3. Ligar um sistema de vcuo externo na porta de suco do KeyHole
Cup com recurso a tubos adequados.
4. Verificar a segurana da ligao entre a porta de suco e os tubos de
vcuo puxando suavemente.
5. Iniciar o sistema de vcuo para criar presso negativa suficiente para
levantar a pele do paciente at alcanar uma posio elevada de
cpula, criando um penumoperitoneu inicial.
NOTA: Durante este passo, pressionar o Cup to firmemente quanto
possvel sobre a pele do paciente para assegurar a suco adequada.
AVISO: No ultrapassar os 15 bar de presso negativa.
6. Inserir a agulha de Veress atravs da porta de insero central do
KeyHole Cup.
7. Verificar se a agulha de Veress foi inserida com a profundidade
desejada e prosseguir com a insuflao, de acordo com os
procedimentos-padro.
8. Libertar gradualmente a presso negativa at que o pneumoperitoneu
inicial tenha sido adequadamente insuflado.
9. Retirar a agulha de Veress logo que alcanar a insuflao pretendida.
10. Desligar o sistema de vcuo e retirar o KeyHole Cup da pele.

CONTRA-INDICAES:
Para minimizar os riscos para a paciente e para o feto, o dispositivo KeyHole
Cup no dever ser utilizado em pacientes grvidas.

ATENO:
Devero ser inspeccionados possveis danos ou quebras no KeyHole Cup
previamente sua utilizao.

ARMAZENAMENTO:
PT
Manusear com cuidado. O KeyHole Cup dever ser armazenado em
condies que o protejam de temperaturas extremas e de humidade.
EN 980:2008 (E)
12
5.8.3 SymboI for "STERILIZED USING IRRADIATION"

NOTE This symbol corresponds to that given in SO 7000-2502 and to symbol number 5.23 in SO 15223-1:2007.
5.8.4 SymboI for "STERILIZED USING STEAM OR DRY HEAT"

NOTE This symbol corresponds to that given in SO 7000-2503 and to symbol number 5.24 in SO 15223-1:2007.

5.9 SymboI for "STERILE USING ASEPTIC PROCESSING TECHNIQUES"

BS EN 980:2008
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Life Care Medical Devices Ltd
Unit 2508A, Bank of America Tower,
Central Hong Kong, PRC

Vascular Newtech Holding SI
Golf de Botnia 8, 08198 San Cugat de
Valles, Barcelona, Spain
Tel: xx-xxx-xxx-xxx

0086
EN 980:2008 (E)
14
5.12 SymboI for "MANUFACTURER"

This symbol shall be accompanied by the name and the address of the manufacturer (the person placing the
device on the market), adjacent to the symbol (see A.6). The address is not required with the symbol on an in vitro
diagnostic device immediate container as specified in EN 375, EN 376, EN 591 and EN 592, except when the
immediate container is also the outer container. Guidance on the requirements for Council Directive 90/385/EEC
and Council Directive 93/42/EEC is given in EN 1041.
NOTE 1 The relative size of the symbol and the size of the name and address are not specified.
NOTE 2 The full definition of 'manufacturer' is given in Council Directives 90/385/EEC, 93/42/EEC and 98/79/EC.
NOTE 3 The date of manufacture as well as the name and address of the manufacturer can be combined in one symbol (see
A.7).

5.13 SymboI for "AUTHORISED REPRESENTATIVE IN THE EUROPEAN COMMUNITY"

This symbol shall be accompanied by the name and the address of the authorised representative in the European
Community, adjacent to the symbol (see A.8). The address is not required with the symbol on an in vitro diagnostic
device immediate container as specified in EN 375, EN 376, EN 591 and EN 592, except when the immediate
container is also the outer container. Guidance on the requirements for Council Directive 90/385/EEC and Council
Directive 93/42/EEC is given in EN 1041.
NOTE The relative size of the symbol and the size of the name and address are not specified.
BS EN 980:2008
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EN 980:2008 (E)
14
5.12 SymboI for "MANUFACTURER"

This symbol shall be accompanied by the name and the address of the manufacturer (the person placing the
device on the market), adjacent to the symbol (see A.6). The address is not required with the symbol on an in vitro
diagnostic device immediate container as specified in EN 375, EN 376, EN 591 and EN 592, except when the
immediate container is also the outer container. Guidance on the requirements for Council Directive 90/385/EEC
and Council Directive 93/42/EEC is given in EN 1041.
NOTE 1 The relative size of the symbol and the size of the name and address are not specified.
NOTE 2 The full definition of 'manufacturer' is given in Council Directives 90/385/EEC, 93/42/EEC and 98/79/EC.
NOTE 3 The date of manufacture as well as the name and address of the manufacturer can be combined in one symbol (see
A.7).

5.13 SymboI for "AUTHORISED REPRESENTATIVE IN THE EUROPEAN COMMUNITY"

This symbol shall be accompanied by the name and the address of the authorised representative in the European
Community, adjacent to the symbol (see A.8). The address is not required with the symbol on an in vitro diagnostic
device immediate container as specified in EN 375, EN 376, EN 591 and EN 592, except when the immediate
container is also the outer container. Guidance on the requirements for Council Directive 90/385/EEC and Council
Directive 93/42/EEC is given in EN 1041.
NOTE The relative size of the symbol and the size of the name and address are not specified.
BS EN 980:2008
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EN 980:2008 (E)
22
6.2 SymboI for "CONTAINS OR PRESENCE OF NATURAL RUBBER LATEX"

NOTE 1 This symbol should be used only when natural rubber latex is a material of construction within the device or the
packaging of a device. t is intended to warn those people who may have allergic reactions to certain proteins in natural rubber
latex. This symbol should not be used for devices containing 'synthetic' rubber.
NOTE 2 This symbol is derived from SO 7000-2725 ("Contains or presence of) and is as given as symbol number 5.25 in
SO/DS 15223-1 DAM 1:2007.
6.3 SymboI for "DO NOT USE IF PACKAGE IS DAMAGED"

NOTE 1 Synonym for "Do not use if package is damaged" is "Do not use if the product sterilization barrier or its packaging is
compromised".
NOTE 2 This symbol corresponds to that given in SO 7000-2606 and to symbol number 5.27 in SO 15223-1:2007.
6.4 SymboI for "STERILE FLUID PATH"

This symbol indicates the presence of a sterile fluid path within the device when other parts of the device, including
the exterior, may not be supplied sterile. The part of the device that is sterile shall be identified in information
supplied by the manufacturer.
The method of sterilization shall be indicated in the empty box, as appropriate (see A.13).
BS EN 980:2008
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EN 980:2008 (E)
19
NOTE This symbol corresponds to that given in SO 7000-0624:2004 and as symbol number 5.6 in SO 15223-1:2007.
5.21 SymboI for "KEEP DRY"


NOTE This symbol corresponds to that given in SO 7000-0626 and to symbol number 5.8 in SO 15223-1:2007 ("Keep
away from rain).
5.22 SymboI for "DO NOT RESTERILIZE"

NOTE This symbol corresponds to that given in SO 7000-2608 and to symbol number 5.25 in SO 15223-1:2007.

BS EN 980:2008
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EN 980:2008 (E)
8
4.2.5 All symbols and information intended for visual recognition shall be legible when viewed under an
illumination of 215 lx using normal vision, corrected if necessary, at a distance which takes into account the
specifics and size of the individual medical device.
NOTE Colours and minimum dimensions are not specified in this standard.
4.2.6 Guidance on the appropriate use of the general prohibition symbol is given in Annex B.
5 SymboIs aIready in use
5.1 GeneraI
This Clause contains symbols that are already in use, and are deemed to be suitable without need for further
explanation.
NOTE Symbols used with medical devices for use by other than healthcare professionals can require additional
explanations.
Annexes ZA, ZB and ZC can be used to determine the symbols that address essential requirements of Council
Directives 93/42/EEC, 90/385/EEC and 98/79/EC respectively.
5.2 SymboI for "DO NOT REUSE"

NOTE 1 Synonyms for "Do not reuse" are "single use, "Use only once".
NOTE 2 This symbol corresponds to that given in SO 7000-1051 and to symbol number 5.2 in SO 15223-1:2007
BS EN 980:2008
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B
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DD-007Rev 1