apei42 expansores web ingles - ticare · 2019-03-25 · no esterilice materiales de distintos tipos...

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Self-taping expanders set is compatible with InHex Mini (InMn), InHex Standard (InSt), InHex (InMx) Maxi, Osseous Mini (OsMn), Osseous Standard (OsSt), Osseous Maxi (OsMx) and Osseous Maxi PS (OsMxPS) platforms. 1. APLICATION: Self-taping expanders set allows performing an alveolus for the subsequent insertion of an endo-osseous implant by means of expansion or compacting technique. It is specially indicated for thin crests or to compact bone in type IV bone crests. It is also suitable to perform cortical Split technique. It is only recommended for upper maxilla. Its designed and markings allow a progressive deepening and facilitate depth and insertion axis control. 2.1.Instructions for use. Alveolus by bone compaction (Pic.1): Step 1: Perform an alveolus with 2.00 mm Initial drill (not included in the set) Step 2: Insert expander No. 1 until the threaded area disappears (8 mm aprox.) turning slowly clockwise (to the right). Then remove it slowly turning counter-clockwise (to the left) (*1) Step 3: Insert expander No. 2 until the appropriate depth according to the implant to be placed (*2) turning slowly clockwise (to the right). Then remove it slowly turning counter-clockwise (to the left). For implants diameter 3.3 and 3.4 mm go directly to step 7. Step 4: Continue the expanding sequence inserting slowly expander No. 3 up to the appropriate depth. For implants diameter 3.75 mm go directly to step 7. Step 5: Insert expander No.4 up to the appropriate depth. For implants diameter 4.25 mm go directly to step 7. Step 6: Complete the expanding sequence inserting slowly expanders No. 5 and No. 6 up to the depth required by the implant. (*3) Step 7: Insert the implant slowly respecting the recommended torque (35 - 45 Ncm). If necessary, wait a few seconds before continuing with the insertion or even rewind if the torque is excessive to extend the expanding sequence until achieving the appropriate insertion torque (*1) In case of an excessive resistance during the insertion of any of the expanders, it is recommended to stop the expansion for several seconds to avoid overheating before continuing until appropriate depth. (*2) See section “ 3. Expanders marking” and 4. “Expanders template” to choose the appropriate depth.. (*3) With dilator expander No. 6 is able to perform sinus lifting via alveolar due to its convex tip. •13200440 Hand wrench for expanders •132004402 Hand wrench stem for expanders •132030402 Expander No. 1 •132030403 Expander No. 2 •1320304033 Expander No. 3 •1320304038 Expander No. 4 •1320304043 Expander No. 5 •1320304047 Expander No. 6 Diameter at the expander tip Diameter at the max. effective length Expander max. effective length Depth marks Expander identification Pic. 1: Steps 1, 2, 3, 4 and 7 of the expanders use sequence to perform the alveolus by bone compaction. 2.2.Instructions for use. Cortical Split with expanders (Pic. 2) Step 1b: Expose the bone of the targeted area and set apart the soft tissues trying to keep the area vascularization. Step 2b. Make a lengthwise incision in the targeted area with a surgical saw. Step 3b: If necessary, mark the expander insertion point or points using the 2mm initial drill (not included in the set) or a ball drill (not included in the set) Step 4b: Follow the sequence described in steps 2 and 7 inserting alternately the appropriate expander in every point or points marked Step 5b: Insert the implants, place the suitable cover or healing screw and suture. Pic. 2: Main steps of expanders sequence use to perform “Cortical Split”. WARNINGS AND CAUTIONS Para la seguridad y efectividad del instrumental se sugiere encarecidamente que el producto sea utilizado por personal cualificado. ESTAS INSTRUCCIONES NO TIENEN POR OBJETO SER UN SUSTITUTIVO DE UNA ADECUADA FORMACIÓN. Todo el producto se suministra NO ESTÉRIL, y debe usarse en condiciones asépticas. CLEANING AND STERILIZATION Los productos se deberán limpiar, desinfectar y esterilizar antes de cada uso; esto se realizará antes del primer uso tras el suministro, ya que los productos se suministran no estériles. Una limpieza y desinfección correctas son condición indispensable para una adecuada esterilización. Rogamos no olvide que el desinfectante utilizado en el tratamiento previo sirve sólo para la protección personal y no reemplaza la operación de esterilización que hay que realizar posteriormente, una vez ejecutada la limpieza. Método de esterilización •Introduzca el producto en bolsas de esterilización. •Coloque el producto en el interior del autoclave. No esterilice materiales de distintos tipos en contacto. •La esterilización por calor húmedo en autoclave 134 ° C (273 ° F) - 5 minutos. Asegúrese de que los elementos, en el interior del autoclave, no están oxidados. •La temperatura de exposición de los productos y las bandejas de esterilización no superará los 137 °C. •Cuando el autoclave haya finalizado extraiga el producto del interior del autoclave. PRODUCT COMPOSITION Todas las piezas que componen el Set qde expansores aautorroscantes están fabricadas en Acero Inoxidable. PACKAGING AND STORAGE Toda la información sobre el producto está en la etiqueta. El embalaje del producto se realiza de forma individual. No se necesitan condiciones especiales de almacenaje ya que las materias primas utilizadas son estables en condiciones de presión y temperaturas normales. Se recomienda almacenar entre temperaturas entre 18ºC y 50ºC y un límite de humedad por debajo del 70%. CONTRAINDICATIONS No se utilizarán aquellos productos que hayan variado sus propiedades con el uso, de forma que no sean seguros para las funciones que están indicadas. LABELLING SYMBOLS MANUFACTURER 3.Markings on expanders: 4. EXPANDERS TEMPLATE: Expanders template specifies, for every single expander, the diameter of the alveolus generated at every depth mark. The template follows a color code according to the different platforms color code of Ticare implants: Green 3.3mm, 3.4mm implants, Blue 3.75mm implants, Purple 4.25mm implants, Turquoise 5mm implants. KIT ELEMENTS: Rev 02: 25/03/2019 Ref:APEI42 SELF-TAPING EXPANDERS SET Nº 2 TIP Ø1.4 L 15 Ø3 BACK FRONT 8 mm:ø 2.0 mm 15 mm:ø 3.0 mm 13 mm:ø 2.8 mm 11.5 mm:ø 2.65 mm 10 mm:ø 2.45 mm 9 mm:ø 2.3 mm 8 mm:ø 2.2 mm 6 mm: ø 2 mm TIP: ø 1.4 mm 15 mm:ø 3.5 mm 13 mm:ø 3.3 mm 11.5 mm:ø 3.1 mm 10 mm:ø 2.9 mm 9 mm:ø 2.75 mm 8 mm:ø 2.6 mm 6 mm: ø 2.4 mm TIP: ø17 mm 15 mm:ø 4.1 mm 13 mm:ø 3.9 mm 11.5 mm:ø 3.6 mm 10 mm:ø 3.4 mm 9 mm:ø 3.25 mm 8 mm:ø 3.1 mm 6 mm: ø 2.85 mm TIP: ø 2.1 mm 15 mm:ø 4.5 mm 13 mm:ø 4.2 mm 11.5 mm:ø 4.0 mm 10 mm:ø 3.8 mm 9 mm:ø 3.6 mm 8 mm:ø 3.4 mm 6 mm: ø 3 mm TIP: ø 2.4 mm 15 mm:ø 4.9 mm 13 mm:ø 4.6 mm 11.5 mm:ø 4.3 mm 10 mm:ø 4.1 mm 9 mm:ø 3.9 mm 8 mm:ø 3.8 mm 6 mm: ø 3.5 mm TIP: ø 2.7 mm TIP:ø 1.0 mm EXPANDER Nº1 EXPANDER Nº2 EXPANDER Nº3 EXPANDER Nº4 EXPANDER Nº5 EXPANDER Nº6 For 5.0 mm implants For 4.25 mm implants For 3.75 mm implants For 3.3 mm implants 15 mm 13 mm 11.5 mm 10 mm 9 mm 8 mm TIP 6 mm 6 mm:ø 1.75 mm See instructions for use Lot Manufacturer Reference CE certificate , S.A. C/ Santiago López González, 7 47197 VALLADOLID (SPAIN) Tel. +34 983211 312 fax: +34 983 304 021 e-mail: [email protected] www.ticareimplants.com MANUFACTURER

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Page 1: APEI42 expansores WEB INGLES - Ticare · 2019-03-25 · No esterilice materiales de distintos tipos en contacto. •La esterilización por calor húmedo en autoclave 134 ° C (273

Self-taping expanders set is compatible with InHex Mini (InMn), InHex Standard (InSt), InHex (InMx) Maxi, Osseous Mini (OsMn), Osseous Standard (OsSt), Osseous Maxi (OsMx) and Osseous Maxi PS (OsMxPS) platforms.

1. APLICATION:Self-taping expanders set allows performing an alveolus for the subsequent insertion of an endo-osseous implant by means of expansion or compacting technique. It is specially indicated for thin crests or to compact bone in type IV bone crests. It is also suitable to perform cortical Split technique. It is only recommended for upper maxilla. Its designed and markings allow a progressive deepening and facilitate depth and insertion axis control.

2.1.Instructions for use. Alveolus by bone compaction (Pic.1):Step 1: Perform an alveolus with 2.00 mm Initial drill (not included in the set)

Step 2: Insert expander No. 1 until the threaded area disappears (8 mm aprox.) turning slowly clockwise (to the right). Then remove it slowly turning counter-clockwise (to the left) (*1)

Step 3: Insert expander No. 2 until the appropriate depth according to the implant to be placed (*2) turning slowly clockwise (to the right). Then remove it slowly turning counter-clockwise (to the left). For implants diameter 3.3 and 3.4 mm go directly to step 7.

Step 4: Continue the expanding sequence inserting slowly expander No. 3 up to the appropriate depth. For implants diameter 3.75 mm go directly to step 7.

Step 5: Insert expander No.4 up to the appropriate depth. For implants diameter 4.25 mm go directly to step 7.

Step 6: Complete the expanding sequence inserting slowly expanders No. 5 and No. 6 up to the depth required by the implant. (*3)

Step 7: Insert the implant slowly respecting the recommended torque (35 - 45 Ncm). If necessary, wait a few seconds before continuing with the insertion or even rewind if the torque is excessive to extend the expanding sequence until achieving the appropriate insertion torque

(*1) In case of an excessive resistance during the insertion of any of the expanders, it is recommended to stop the expansion for several seconds to avoid overheating before continuing until appropriate depth.

(*2) See section “ 3. Expanders marking” and 4. “Expanders template” to choose the appropriate depth..

(*3) With dilator expander No. 6 is able to perform sinus lifting via alveolar due to its convex tip.

•13200440 Hand wrench for expanders •132004402 Hand wrench stem for expanders•132030402 Expander No. 1•132030403 Expander No. 2•1320304033 Expander No. 3•1320304038 Expander No. 4•1320304043 Expander No. 5•1320304047 Expander No. 6

Diameter at the expander tip

Diameter at the max. e�ective length

Expander max. e�ective length

Depth marks

Expander identification

Pic. 1: Steps 1, 2, 3, 4 and 7 of the expanders use sequence to perform the alveolus by bone compaction.

2.2.Instructions for use. Cortical Split with expanders (Pic. 2)Step 1b: Expose the bone of the targeted area and set apart the soft tissues trying to keep the area vascularization.

Step 2b. Make a lengthwise incision in the targeted area with a surgical saw.

Step 3b: If necessary, mark the expander insertion point or points using the 2mm initial drill (not included in the set) or a ball drill (not included in the set)

Step 4b: Follow the sequence described in steps 2 and 7 inserting alternately the appropriate expander in every point or points marked

Step 5b: Insert the implants, place the suitable cover or healing screw and suture.

Pic. 2: Main steps of expanders sequence use to perform “Cortical Split”.

WARNINGS AND CAUTIONS

Para la seguridad y efectividad del instrumental se sugiere encarecidamente que el producto sea utilizado por personal cualificado. ESTAS INSTRUCCIONES NO TIENEN POR OBJETO SER UN SUSTITUTIVO DE UNA ADECUADA FORMACIÓN. Todo el producto se suministra NO ESTÉRIL, y debe usarse en condiciones asépticas.

CLEANING AND STERILIZATION

Los productos se deberán limpiar, desinfectar y esterilizar antes de cada uso; esto se realizará antes del primer uso tras el suministro, ya que los productos se suministran no estériles. Una limpieza y desinfección correctas son condición indispensable para una adecuada esterilización. Rogamos no olvide que el desinfectante utilizado en el tratamiento previo sirve sólo para la protección personal y no reemplaza la operación de esterilización que hay que realizar posteriormente, una vez ejecutada la limpieza. Método de esterilización•Introduzca el producto en bolsas de esterilización.•Coloque el producto en el interior del autoclave. No esterilice materiales de distintos tipos en contacto.•La esterilización por calor húmedo en autoclave 134 ° C (273 ° F) - 5 minutos. Asegúrese de que los elementos, en el interior del autoclave, no están oxidados. •La temperatura de exposición de los productos y las bandejas de esterilización no superará los 137 °C.•Cuando el autoclave haya finalizado extraiga el producto del interior del autoclave.

PRODUCT COMPOSITION

Todas las piezas que componen el Set qde expansores aautorroscantes están fabricadas en Acero Inoxidable.

PACKAGING AND STORAGE

Toda la información sobre el producto está en la etiqueta. El embalaje del producto se realiza de forma individual.

No se necesitan condiciones especiales de almacenaje ya que las materias primas utilizadas son estables en condiciones de presión y temperaturas normales. Se recomienda almacenar entre temperaturas entre 18ºC y 50ºC y un límite de humedad por debajo del 70%.

CONTRAINDICATIONS

No se utilizarán aquellos productos que hayan variado sus propiedades con el uso, de forma que no sean seguros para las funciones que están indicadas.

LABELLING SYMBOLS

MANUFACTURER

3.Markings on expanders:

4. EXPANDERS TEMPLATE:Expanders template specifies, for every single expander, the diameter of the alveolus generated at every depth mark. The template follows a color code according to the di�erent platforms color code of Ticare implants: Green 3.3mm, 3.4mm implants, Blue 3.75mm implants, Purple 4.25mm implants, Turquoise 5mm implants.

KIT ELEMENTS:

Rev 02: 25/03/2019Ref:APEI42

SELF-TAPING EXPANDERS SET

Nº 2 TIP Ø1.4L 15 Ø3

BACKFRONT

8 mm:ø 2.0 mm

15 mm:ø 3.0 mm

13 mm:ø 2.8 mm

11.5 mm:ø 2.65 mm

10 mm:ø 2.45 mm

9 mm:ø 2.3 mm

8 mm:ø 2.2 mm

6 mm: ø 2 mm

TIP: ø 1.4 mm

15 mm:ø 3.5 mm

13 mm:ø 3.3 mm

11.5 mm:ø 3.1 mm

10 mm:ø 2.9 mm

9 mm:ø 2.75 mm

8 mm:ø 2.6 mm

6 mm: ø 2.4 mm

TIP: ø17 mm

15 mm:ø 4.1 mm

13 mm:ø 3.9 mm

11.5 mm:ø 3.6 mm

10 mm:ø 3.4 mm

9 mm:ø 3.25 mm

8 mm:ø 3.1 mm

6 mm: ø 2.85 mm

TIP: ø 2.1 mm

15 mm:ø 4.5 mm

13 mm:ø 4.2 mm

11.5 mm:ø 4.0 mm

10 mm:ø 3.8 mm

9 mm:ø 3.6 mm

8 mm:ø 3.4 mm

6 mm: ø 3 mm

TIP: ø 2.4 mm

15 mm:ø 4.9 mm

13 mm:ø 4.6 mm

11.5 mm:ø 4.3 mm

10 mm:ø 4.1 mm

9 mm:ø 3.9 mm

8 mm:ø 3.8 mm

6 mm: ø 3.5 mm

TIP: ø 2.7 mmTIP:ø 1.0 mm

EXPANDER Nº1 EXPANDER Nº2 EXPANDER Nº3 EXPANDER Nº4 EXPANDER Nº5 EXPANDER Nº6

For 5.0 mm implants

For 4.25 mm implants

For 3.75 mm implants

For 3.3 mm implants

15 mm

13 mm11.5 mm

10 mm9 mm8 mm

TIP

6 mm

6 mm:ø 1.75 mm

See instructions foruse

Lot

Manufacturer

Reference

CE certificate

, S.A.C/ Santiago López González, 7

47197 VALLADOLID (SPAIN)Tel. +34 983211 312 fax: +34 983 304 021

e-mail: [email protected]

MANUFACTURER