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5

ENGLISH

Cautions

• 

 Insert the dilator into the center of the sheath valve. 
Forced insertion of the dilator which misses the center 
of the sheath valve may cause damage, and result in 
blood leakage.

• 

 Lock the dilator hub into the sheath hub securely. If the 
dilator hub is not locked into the sheath hub, only the 
sheath will advance into the vessel and the tip of the 
sheath may damage the vessel. Advancing the sheath 
alone may cause damage to the vessel.

8. 

 Insert the dilator and sheath together over the mini 
guidewire, and into the blood vessel (Fig. 4).

9. 

 “Unlock” the dilator hub from the sheath hub by bending 
the dilator hub downward (Fig. 5).

10.   Slowly remove the dilator and mini guidewire together, 

leaving the sheath in the vessel (Fig. 6). If injection or 
sampling is necessary at this point, remove the mini 
guidewire only, and use the dilator hub as an injection port 
before removing it. 

Caution

• 

 Slowly remove the dilator from the sheath. Rapid 
withdrawal of the dilator may result in the incomplete 
closing of the 1-way valve, resulting in blood fl ow 
through the valve. If this occurs, replace the dilator into 
the sheath and remove again slowly.

11.   Insert a catheter through the sheath and into the blood 

vessel, and advance to the desired location (Fig. 7).

Fig. 4

Fig. 5

Fig. 6

Fig. 7

Sheath

Dilator

Mini 
Guidewire

3-Way Stopcock

Lever

Dilator

Mini Guidewire

Dilator Hub

Suture Hub

Mini Guidewire

Catheter

PM-01979

Summary of Contents for Pinnacle Precision Access System Series

Page 1: ...ainha Introdutora Read These Instructions Before Use Lire le mode d emploi avant utilisation Leer estas instrucciones antes del uso Leia estas instru es antes de utilizar Instructions for Use 3 Mode d...

Page 2: ...ON TERUMO y Pinnacle son marcas registradas de TERUMO CORPORATION PRECISION ACCESS SYSTEM es una marca registrada de TERUMO MEDICAL COPORATION TERUMO e Pinnacle s o marcas registadas da TERUMO CORPORA...

Page 3: ...the sheath allows for simultaneous motion of both dilator and sheath Spring Coil Mini Guidewire or Nitinol Mandrel Guidewire A 45 cm stainless steel guidewire or 43 cm Nitinol guidewire with 0 21 inc...

Page 4: ...ncision at the puncture site with a surgical knife 2 Insert a cannula into the vessel Fig 1 3 Insert the selected flexible end of the mini guidewire through the cannula into the vessel Fig 2 Caution A...

Page 5: ...nding the dilator hub downward Fig 5 10 Slowly remove the dilator and mini guidewire together leaving the sheath in the vessel Fig 6 If injection or sampling is necessary at this point remove the mini...

Page 6: ...way stopcock Fig 9 12 When inserting manipulating or withdrawing a catheter from the sheath always hold it in place To temporarily suture the sheath for continued access use the suture eye Cautions Do...

Page 7: ...aux coudures Dilatateur L ajustement pr cis du dilatateur dans la gaine permet le d placement simultan du dilatateur et de la gaine Mini fil guide spire ou fil guide mandrin en nitinol Un fil guide e...

Page 8: ...ar un m decin ou sur prescription d un m decin MODE D EMPLOI 1 l aide d une lame de bistouri pratiquer une petite incision de la peau au point de ponction 2 Introduire la canule dans le vaisseau sangu...

Page 9: ...eur vers le bas Fig 5 10 Retirer lentement et simultan ment le dilatateur et le mini guide en laissant la gaine dans le vaisseau Fig 6 S il est n cessaire de pratiquer une injection ou une prise de sa...

Page 10: ...r manipuler ou retirer un cath ter de la gaine toujours maintenir cette derni re en place Pour suturer temporairement la gaine pour un acc s permanent utiliser l oeilleton de suture MISE EN GARDE Ne p...

Page 11: ...ca fuga de sangre en la v lvula de una v a Esta vaina altamente flexible est dise ada para resistir dobleces Dilatador El acoplamiento preciso del dilatador en la vaina permite el movimiento simult ne...

Page 12: ...ales EE UU restringen la venta de este dispositivo a m dicos o a personas en su nombre INSTRUCCIONES DE USO 1 Hacer una peque a incisi n en la piel en el sitio de punci n con un bistur 2 Insertar la c...

Page 13: ...ndo el conector del dilatador hacia abajo Fig 5 10 Extraer despacio el dilatador y la mini gu a juntos dejando la vaina en el vaso Fig 6 Si en este momento se necesita inyectar o tomar muestras extrae...

Page 14: ...rtar manipular o extraer un cat ter de la vaina sujetarlo siempre en su lugar Para suturar temporalmente la vaina para obtener acceso continuo usar el ojal de sutura PRECAUCIONES No poner sutura en el...

Page 15: ...de uma via Esta bainha altamente flex vel foi projetada para resistir a dobras Dilatador O encaixe preciso do dilatador na bainha permite que ambos o dilatador e a bainha sejam movidos simultaneament...

Page 16: ...ubo lateral e da v lvula reguladora de 3 vias ATEN O A lei federal EUA s permite a venda deste dispositivo por m dicos ou sob receita m dica INSTRU ES PARA UTILIZA O 1 Fa a uma pequena incis o na pele...

Page 17: ...latador para baixo Fig 5 10 Remova o dilatador e o mini fio guia juntos lentamente deixando a bainha no vaso Fig 6 Se for necess rio efetuar uma inje o ou uma coleta de amostras neste momento remova o...

Page 18: ...a reguladora de 3 vias Fig 9 12 Quando inserir manipular ou remover um cateter da bainha mantenhaa sempre no lugar Para suturar a bainha temporariamente para acesso cont nuo use o buraco da agulha ATE...

Page 19: ...19 This page intentionally left blank Page blanche Esta p gina foi deixada em branco intencionalmente Esta p gina se deja en blanco intencionalmente PM 01979...

Page 20: ...d for single use only Do not reuse Do not resterilize Do not reprocess as reprocessing may compromise the biocompatibility and functional integrity of the product Ce dispositif est usage strict unique...

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