GBA RonchoSan m-protect EN · Instruction Sheet m-protect (EN) 3 m-protect is intended exclusively for use as an insertion guide of stapler instruments within transanal stapled anastomosis

Instruction Sheet

EN Date of Information: 2011/10

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Instruction Sheet m-protect (EN) 2

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Imprint:

Editor:Ronchosan GmbHRealization and distribution of medical products innovationsAddress:Schwaigerweg 2D-85625 Baiern (Germany)Contact:e-mail: [email protected]: +49(0)8093 88 89 095Fax: +49(0)8093 88 89 096Web: www.ronchosan.deGeneral Manager: Georg Schmidt · Sabine RadmacherCommercial Register: District Court Munich, HRB 182229VAT ID: DE268404065

Thank you for choosing thisinnovative medical product of RonchoSan!

Through the application of m-protect®, the progressive and non-traumaticalternative to the conventional method without insertion guide, you will help to

improve the safety of transanal stapled anastomosis significantly by the factthat you effectively prevent known risks - such as sphincter lesions and postop-

erative continence problems – of this operation.


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m-protect is intended exclusively for use as an insertion guide of staplerinstruments within transanal stapled anastomosis.

m-protect may be used only by persons who have appropriate qualifications andhave read this instruction sheet carefully and completely before the first use of m-protect.

Each use which is different from one or more of the above mentioned criteria ofintended use is considered as non-intended use (misuse), and is expresslyforbidden. This includes also unauthorized changes to the product.

Disclaimer of the manufacturer and the distributor in case of non-intended use(misuse) of m-protect:

Neither the manufacturer nor the distributor of m-protect assumes any liability todamage to persons or/and damage to property due to any use which is differentfrom the above mentioned intended use (non-intended use, respectively misuse) ofm-protect.

Disclaimer of the technical editor of this instruction sheet in case of non-intendeduse (misuse) of m-protect:

The technical editor of this instruction sheet assumes no liability to damage topersons or/and damage to property due to any use which is different from theabove mentioned intended use (non-intended use, resp. misuse) of m-protect.

Intended Use

Important Notes

This instruction sheet is intended exclusively for people who are charged with theuse of the m-protect and meet all requirements in connection with the intended usementioned above.

Before the first use of m-protect read this instruction sheet carefully and completely!Only in this way you can familiarize yourself with the product and use it afterwardssafely and correctly.


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About this Instruction Sheet

This chapter explains the safety notes and further important symbols in thisinstruction sheet.

Explanation of safety notesThe safety notes (warnings) in this instruction sheet comply with ANSI Z535.6.

Below we explain the specific meaning of the ANSI warnings in the context of medicaldocumentation, as they are also present in this instruction sheet.

Warning of potential danger. This means that the non-observance of the precautions strongly recommended inthe accompanying text will likely result in serious,irreversible disease and / or injuries, possibly even in thedeath of the patient.

Warning of a possible but not imminent danger. Thismeans that the non-observance of the precautionsrecommended in the accompanying text can well result indiseases and / or injuries of the patient, but these arereversible.

Explanation of further important symbols in this instruction sheetIn this instruction sheet you will encounter several symbols that serve the purpose toimprove comprehensibility and clarity of presentation and thereby facilitate the safeand correct handling of the product under normal operating conditions:i = Important!These points require special attention.

i= InformationThis symbol indicates specific and additional information.è = ResultThrough this symbol ("follow arrow") a certain action step is linked with the result ofthis action; i.e.: after the symbol the result of the previous action will be explained.Example:m-protect is fully and firmly attached to the staplerè The stapler is ready for use

►= Reference MarkThis symbol refers to a passage of text and / or an image that is located on a differentplace in this instruction sheet, but related with the facts described.

F= Tip for the practical use of the product


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Contents

Imprint 2

Intended Use 3

Important Notes 3

About this Instruction Sheet 4

Safety Notes and Precautions 6

Operating Principles and Advantages of m-protect 7

Overview 7

Application of m-protect 8

Disposal 14

Technical Data 14

Index 15


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Safety Notes and Precautions

Precautions relating to use

ANSI-Safety Notes

After the stapler was inserted and the surgical area was reached, you have toretract the insertion guide m-protect far enough, i.e. complete across theupper end of the stapler shaft. Otherwise the danger is that the insertionguide m-protect gets into the staple line of the anastomosis and this may leadto complications. ►Details p. 10, fig. 6, p. 10 + fig. 7, p. 11

General Precautions

The staff charged with the preparation, handling anddisposal of m-protect, must comply with current hygieneregulations for clinic staff.

The staff charged with the preparation, handling anddisposal of m-protect, must observe the current hygieneregulations in the clinic area.

During preparation, handling and disposal of m-protectsterile surgical protective clothing must be worn.

During preparation, handling and disposal of m-protectsterile surgical gloves must be worn.

m-protect must be attached correct and firmly to the stapler to avoid directcontact of the stapler with the intestinal mucosa. Otherwise, as in theprocedure without m-protect, mucosal lesions are possible.►Details p. 9, fig. 4 + 5


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Operating Principles and Advantages of m-protect

For decades, transanal stapled-anastomosis using stapler instruments is among thesurgical procedures for treatment of benign and malign diseases of the rectum andthe sigmoid the method of first choice.Known complications of this procedure, such as sphincter lesions and postoperativecontinence problems will be avoided reliable by the usage of the insertion guide m-protect.m-protect acts like a snow plough shielding the blunt edge of the stapler to ensure asecure and non-traumatic insertion through the sphincter area while avoiding beingcaught in mucosa folds.

i m-protect is suitable for all common staplers.

Overview

CAP(TOTAL)

ENLACEMENT(TOTAL)

PULL LOOP

CAP(UPPER END)

CAP(BASIS)

fig. 1

HANDHOLD

ENLACEMENT(LOWER RING)

ENLACEMENT(UPPER RING)


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Application of m-protect

This chapter explains the use of m-protect step by step.

Attaching of m-protect to the stapler ► figures 2, 3, 4

fig. 2

PULL LOOP(M-PROTECT)

STAPLER SHAFT(UPPER END)


CAP

LOWER RING(ENLACEMENT)

fig. 3

UPPER RING(ENLACEMENT)

� Move the stapler shaft with the upper end forward through the pullloop of m-protect (► fig. 2)

� Then set the cap of m-protect loose on the upper end of the staplershaft and attach the stapler shaft such a way in the enlacement ofm-protect (► figure 1, p. 7), that the upper ring and the lower ringsurround the stapler shaft (► figure 3)


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Attaching of m-protect to the stapler, continuation Application of m-protect

� Pull the handhold of m-protect in arrow direction (white arrow) on the lowersection of the stapler shaft (► figure 4), simultaneously set the cap of mprotectfirmly on the upper end of the stapler shaft

� mprotect is fully and firmly attached to the stapler (► figures 4 and 5)è Thestapler is ready for useFYou make the insertion easier by applying sterile lubricating gel to the cap ofm-protect. In case of stapler sizes up to 29 millimeters the previous use of adilatation stick is then no longer necessary

I

m-protect m-protect must be attached correct and firmly to the stapler. Only in thisway it can unfold its optimal effect! (► Safety Note,Chap. Safety Notes and Precau-tions, p. 6).

HANDHOLD(PULL LOOP)

CAP

STAPLER SHAFT(LOWER SECTION)

Referring to figure 5: Thestapler and m-protectform an unitè Thestapler can now beinserted transanal up tothe anastomosis-area


fig. 4

fig. 5, detail view, side


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During Surgery ► figures 6, et seq.

After the stapler was inserted and the anastomosis area was reached, m-protectmust be retracted.

iFor details on the operation of the stapler and various anastomosis methods, pleaserefer to the manual of the stapler you are using.

iThe procedure described below refers to an anastomosis method in which a trocarspike is used.

IThe procedure described below, in particular the safety note on page 11 and inchapter Safety Notes and Precautions, p. 6, always applies, regardless of the usedstapler

fig. 6


Retracting m-protect ► fig. 6 + fig. 7, p. 11

STAPLER SHAFT (UPPER END) HANDHOLD (PULL LOOP)

Recommended Procedure (► fig. 6):

� After reaching the anastomosis area (linear staple line) pull m-protect at thehandhold of the pull loop (► fig. 1, p. 7, fig. 2, p. 8, fig. 4, p. 9) back gently inarrow direction (white arrow) across the upper end of the stapler shaft as shownbelow in figure 6

Im-protect must be retracted before the trocar spike is moved out!

CAP


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During Surgery, Continuation

fig. 7


After the stapler was inserted and the surgical area was reached, you have to retractthe insertion guide m-protect far enough, i.e. complete across the upper end of thestapler shaft as described in the section "Retracting m-protect" on page 10 and belowin figure 7, resp. in fig. 6, p. 10! Otherwise the danger is that the insertion guide m-protect gets into the staple line of the anastomosis and this may lead tocomplications.

FYou make retracting easier by applying to the inner surface of the cap of m-protect sterile lubricating gel (only a minimal amount!)

� Make sure that m-protect was retracted completely across the upper end of thestapler shaft (► safety note below and in chapter Safety Notes and Precautions,p. 6)

� m-protect has been retracted complete across the upper end of the staplershaft► fig. 7 + fig. 6, p. 10è The trocar spike can be moved outProcedure ► p. 12, fig. 8, p. 12 + fig. 9, p. 13 (detail view)

CAP OF VON M-PROTECT, COMPLETE RETRACTED

STAPLER SHAFT (UPPER END)


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fig. 8

Application of m-protect During Surgery, Continuation

Moving out the trocar spike ► fig. 8 + fig. 9, p. 13

IThe trocar spike may only be moved out after m-protect was retracted!

Recommended Procedure:

� Move out the trocar spike completely in accordance with the instructions inthe manual of the stapler you are using► fig. 8 + fig. 9, p. 13 (detail view)è In this connection, as desired, you already penetrate the transsectionline (linear staple line)

� During this insert the stapler carefully a few millimeters furtherè When m-protect was retracted you can perform the anastomosis asusual by connecting the trocar spike with the pressure plate

TROCAR SPIKE, MOVED OUT COMPLETE

CAP OF M-PROTECT, RETRACTED CORRECTLY


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During Surgery, Continuation Application of m-protect

TROCAR SPIKE, MOVED OUT COMPLETE

CAP OF M-PROTECT,RETRACTED CORRECTLY

fig. 9, detail view

iSummary� m-protect has been retracted complete across the upper end of the stapler shaft

►fig. 7, p. 11 + fig. 6, p. 10� Then the trocar spike was moved out

► fig. 9 (detail view) + fig. 8, p. 12èNow the anastomosis can be started


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Disposal

Im-protect is only for single use and to dispose directly after use in accordancewith the applicable regulations for disposable medical products.

Technical Data

Weight (format 28/29): 11,6 gLength (diagonal): 260 mmØ Cap (upper end ): 32 mmØ enlacement: 26 mmHandhold pull loop (width): 36 mmMaterial: TPE HTM8502/42

Technical Editor

DESCRIPTECTechnische DokumentationAlbrecht Lehre (GbR)Bahnhofplatz 6D-73441 Bopfingen (Germany)Phone: +49(0)7362 9562-988Fax: +49(0)7362 9562-987e-mail: [email protected]: www.descriptec.com


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Index

AAnastomosistransanal stapled 7Applicationm-protect 8Attachingto the stapler 8

CComplicationsstapled anastomosis 7Continencepostoperative problems 7

EExplanationSafety Notes 4Symbols 4

NNotesimportant 3

OOperatingprinciples 7Overviewm-protect 7

PPrecautionsgeneral 6relating to use 6

RRetractingm-protect 10m-protect, Security Note 11

SSafetyNotes, ANSI 6Sphincterlesions 7

TTrocarmoving out 12

UUseintended 3

Instruction Sheet

EN0483

Documents

GBA RonchoSan m-protect EN · Instruction Sheet m-protect (EN) 3 m-protect is intended exclusively for use as an insertion guide of stapler instruments within transanal stapled anastomosis