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ESIN Plug Insert and Aiming Device ESIN ... - Hofer-medical

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Instruction Manual<br />

<strong>ESIN</strong> <strong>Plug</strong> <strong>Insert</strong> <strong>and</strong> <strong>Aiming</strong> <strong>Device</strong><br />

<strong>ESIN</strong> Measurement Gauge<br />

www.hofer-<strong>medical</strong>.com


Content<br />

Single Parts<br />

PI-1<br />

Intra-operative H<strong>and</strong>ling<br />

PI-2<br />

Assembling Instrument<br />

PI-2.1<br />

Connecting <strong>Plug</strong><br />

PI-2.2<br />

<strong>Insert</strong>ion of Sleeve System<br />

PI-2.3<br />

Using Measurement Gauge<br />

PI-2.4<br />

Disconnecting <strong>Plug</strong><br />

PI-2.5<br />

Post-operative H<strong>and</strong>ling<br />

PI-3<br />

Preparation<br />

PI-3.1<br />

Symbols<br />

Do not hammer in!<br />

Do not touch!<br />

Warning<br />

This description is not sufficient for immediate use of implants <strong>and</strong> instruments.<br />

An instruction into h<strong>and</strong>ling these instruments by a surgeon experienced with them is strongly recommended.


PI-1<br />

Single Parts<br />

C<br />

A<br />

D<br />

B<br />

A - <strong>Aiming</strong> <strong>Device</strong><br />

B - <strong>Insert</strong>er: 35° (st<strong>and</strong>ard) or 25° (optional)<br />

C - Fixation Screw (F)<br />

D - Clamping Screw (CS)<br />

E - Fixation Bolt<br />

E<br />

<strong>ESIN</strong> Trocar<br />

<strong>ESIN</strong> Drill Sleeve<br />

<strong>ESIN</strong> Tissue Protector Sleeve<br />

<strong>ESIN</strong> Measurement Gauge<br />

Drill Bit


PI-2.1<br />

Intraoperative H<strong>and</strong>ling - Assembling Instrument<br />

Assembling of Instrument - Steps<br />

35°<br />

25°<br />

1 - Lead inserter (25° or 35°) into aiming device all the way<br />

to the stop - skid of inserter has to point upwards, inserted<br />

hole in aiming device <strong>and</strong> groove of inserter should be in<br />

one line<br />

1<br />

1<br />

3<br />

Lateral view opposite side<br />

2<br />

3<br />

2 - Fix aiming device by means of the clamping screw (CS) -<br />

clamping screw should be screwed in until it is positioned<br />

flush to the aiming device<br />

3 - Depending on the used version (25° oder 35°) screw in<br />

fixation screw (F) in correspondingly marked position (see<br />

detail view)<br />

2<br />

Detail<br />

3<br />

25°<br />

35°<br />

Lateral view opposite side<br />

4 - Tighten clamping screw with flat wrench<br />

4<br />

4


PI-2.2<br />

Intra-operative H<strong>and</strong>ling - Connecting <strong>Plug</strong><br />

Connecting <strong>Plug</strong> - Steps<br />

1<br />

1 - For connecting the plug the inserter is put on the plug<br />

from above. In doing so the plug has to be positioned on a<br />

solid surface.<br />

IMPORTANT: Pay attention to the correct alignment of<br />

the plug. The holes in plug <strong>and</strong> inserter have to correspond<br />

to eachother (see detail views).<br />

Detail lateral view<br />

Detail front view<br />

1<br />

1<br />

Check:<br />

1) correct alignment /<br />

position of plug?<br />

2) hole freely accessible?<br />

2- Screw fixation bolt in the inserter all the way to the<br />

stop to fix the plug (2).<br />

2<br />

ATTENTION: During screwing in do not touch the front<br />

part of the instrument (skid area)! The tip of the fixation<br />

bolt might damage gloves.<br />

Do not use fixation bolt or plug together with a hammer!<br />

The connection of the plug to the nail <strong>and</strong> an eventually correction of the position (see surgical technique)<br />

has to happen without using a hammer!


PI-2.3<br />

Intraoperative H<strong>and</strong>ling - <strong>Insert</strong>ion of Sleeve System<br />

Please note: The following steps are performed at different stages during surgery. For more information on<br />

use - especially on time of use - of the sleeve system please refer to the surgical technique.<br />

Depending on the used inserter (35° or 25°) the tissue protector sleeve (A) is inserted in the correspondingly marked<br />

hole of the aiming device.<br />

Attention: The tissue protector sleeve is not self retaining <strong>and</strong> may slip out, if it is not fixed by means of the fixation<br />

screw (F).<br />

The drill sleeve (B) exactly fits in the tissue protector sleeve. Finally, the trocar (C) can be inserted in the drill sleeve.<br />

C<br />

B<br />

A<br />

35° Version - St<strong>and</strong>ard 25° Version - Optional<br />

back hole<br />

front hole<br />

Lateral view detail opposite side<br />

Lateral view detail opposite side


PI-2.4<br />

Intra-operative H<strong>and</strong>ling - Using the Measurement Gauge<br />

Direct Reading of drill bit protrusion<br />

Example: here = 30<br />

B<br />

Pay attention to the correct alignment of the measurement gauge!<br />

Scaling should increase in downward direction!<br />

A<br />

ATTENTION:<br />

Use measurement gauge only in combination with tissue protector sleeve (A) AND drill sleeve (B)!<br />

For measuring only use drill with length of 175 mm!<br />

B<br />

A


PI-2.5<br />

Intra-operative H<strong>and</strong>ling - Disconnecting <strong>Plug</strong><br />

For disconnection of the plug the fixation bolt is unscrewed totally (1). Then the inserter can be taken off from the<br />

plug (2).<br />

1<br />

2


PI-3.1<br />

Post-operative H<strong>and</strong>ling - Preparation<br />

The instrument must be disassembled before cleaning according to the pictures.<br />

3<br />

Disassembling - steps<br />

2<br />

1 - Unscrew fixation bolt<br />

2 - Loosen <strong>and</strong> unscrew clamping screw (if necessary<br />

use flat wrench)<br />

3 - Unscrew fixation screw<br />

1<br />

4 - Remove inserter from aiming device<br />

4<br />

<strong>Insert</strong>er <strong>and</strong>/or aiming device should be exchanged if:<br />

• they show no strong connection anymore<br />

• the aiming device does not guide the sleeve system properly anymore<br />

• the plug can not be connected safely to the inserter anymore<br />

• safe h<strong>and</strong>ling is negatively affected in any other form


Area for Notices


Epilogue<br />

© 2012 <strong>Hofer</strong> GmbH & Co KG. All rights reserved.<br />

Operation Manuals, H<strong>and</strong>books, H<strong>and</strong>outs <strong>and</strong> Software are proprietary. Copies, duplicates, translations or conversion of<br />

any form in a whole or only in parts are not allowed without a prior written approval by HOFER.<br />

Any further rights for the software are specified in the provided licence regulation.<br />

The HOFER logo is a registered trademark of the <strong>Hofer</strong> GmbH & Co KG in Austria <strong>and</strong> other countries.<br />

The rights at other br<strong>and</strong> <strong>and</strong> product names mentioned in this document lie with its owners <strong>and</strong> are recognized hereby.<br />

The mentioning of products which aren‘t from HOFER serves exclusively for information purposes <strong>and</strong> doesn‘t represent<br />

advertisement of any form. HOFER doesn‘t take on any liability with regard to the choice, performance or usability of<br />

the products.<br />

The methods specified in this document, modes of operation <strong>and</strong> the like were carefully checked. If faults or suggestions<br />

for improvement should st<strong>and</strong> out, however, despite this examination, then we ask you to inform us about these. The<br />

operation method represented here introduces merely a possible method for the indication to be treated. It remains<br />

to the decision of the respective surgeon to hold on to the described surgical technique or to vary it according to the<br />

requirements. Direct <strong>and</strong> indirect damages as well as consequential damages are therefore excluded in every case.<br />

Please do not hesitate to contact us for further information.<br />

20120511da_<strong>ESIN</strong>_<strong>Plug</strong>_Instrument_<strong>and</strong>_<strong>ESIN</strong>_Measurement_Gauge_Instruction_Manual-ge.indd<br />

Rev. May 2012<br />

<strong>Hofer</strong> GmbH & Co KG<br />

Fehringerstrasse 45<br />

A-8280 Fürstenfeld<br />

TEL: +43 (0)3382/53388<br />

FAX: +43 (0)3382/53093<br />

office@hofer-<strong>medical</strong>.com<br />

www.hofer-<strong>medical</strong>.com<br />

FN21826y<br />

UID ATU30764704

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