TopClosure -Tension Relief System

Transcription

1 Knwn allergy t adhesives/tapes. Thin, fragile sensitive skin. TpClsure -Tensin Relief System BEFORE USING THIS PRODUCT, READ THE FOLLOWING INFORMATION THOROUGHLY Uncperative patients. D nt apply excessive shearing frces at all TpClsure usages. Always apply gentle gradual tensin t the skin when apprximating tissues. IMPORTANT! This instructins guide is designed t assist in using this prduct. It is nt a reference t surgical techniques. TpClsure intended use is fr Skin Stretching and Secure Wund Clsure. This device was designed, tested and manufactured fr single patient use nly. Reuse r reprcessing f this device may lead t its failure and subsequent patient injury. D nt reuse, reprcess r re-sterilize this device. Reprcessing and/ r re-sterilizatin f this device may create the risk f prduct malfunctin, cntaminatin and infectin. Prper handling f the device ensures infectin cntrl and reduced cntaminatin risk. D nt use if the sterile packaging is damaged r pened. Discard prduct after use. Stre away frm light in a cl, dry place. Optimal strage cnditins at temperatures between C and relative humidity between 40-70%. This package insert is designed t prvide instructins fr use f TpClsure. It is nt a reference t skin stretching techniques. Please read all infrmatin carefully. Failure t prperly fllw the instructins may lead t serius surgical cnsequences. Instructins fr use Preparatins fr TpClsure Applicatin Prir t applicatin assess the expected tensin n the skin and chse the apprpriate TpClsure size rientatin and number f systems t be used. Evaluate the prper psitining f the attachment plates acrss the wund r lesin. Fr curved surface bend the attachment plates at the transverse indentatin in rder t accmmdate skin surface curvature befre applicatin. If the TpClsure is used n an pen wund make sure yu cver it with gauze r a bandage befre the strap is placed n it. Imprtant nte: D nt use TpClsure in the fllwing cases: TpClsure Nn Invasive Applicatin Open the blister using sterile technique and remve the attachment plates and apprximatin straps required fr the applicatin. Apply n skin which has been shaven, cleansed with Isprpyl Alchl spnge and dried thrughly. Adjust the attachment plates t the skin surface by bending them alng the designated hrizntal indentatins, as needed. Peel ff the paper cver frm the adhesive tape n the back f the attachment plates, avid tuching the adhesive. Place the plates and attach them t the skin n bth sides f the lesin r wund (see illustratin 1, step1). The apprximatin plates shuld be psitined cm away frm the wund edges. Firmly adhere t skin. Further secure the attachment plate t the skin with additinal medical hypallergenic tape, t prevent unintentinal peeling f the plate frm the skin. Insert the strap t the lcking/ release mechanism (LR/M) f ne plate and then t the remte plate (see illustratins 1, steps 2, 3). While inserting the strap thrugh the LR/M f the remte plate, be sure t press dwn n the prximal end f the plate t avid its detachment frm the skin. Make sure that the apprximatin strap's wing is interfaced with the lcking/release mechanism f the first plate. Tighten the apprximatin strap gradually t enable the skin stretching (see illustratin 1, step 4). Cut shrtly the apprximatin strap as clinically indicated and secure stump t the plate with a tape. The adhesive is extremely durable under shear frces, yet can be easily peeled ff when needed. In rder t prevent inadvertent peel f the plate frm the skin and t further secure the attachment plate t the skin, apply an additinal medical hypallergenic drape (prvided by IVT Medical Ltd. as an accessry in the TpClsure 1S, 1S-AD and 1S-M System packages). T further secure the system, it is advisable t circumferentially wrap it with elastic bandage. The TpClsure shuld be remved every 4 days, replaced and repsitined if necessary. T release tensin, gently lift the tab f the LR/M and then withdraw Detach the attachment plates frm the patient's skin (when an additinal medical adhesive tape has been used- remve it first).

2 Make sure that the apprximatin strap's wing is interfaced with the lcking/release mechanism f the first plate. Tighten the apprximatin strap gradually t enable skin stretching fr reductin f wund edges gap. Cut shrtly the apprximatin strap as clinically indicated and secure stump t the plate with a tape. The adhesive is extremely durable under shear frces, yet can be easily peeled ff when needed. In rder t prevent inadvertent peel f the plate frm the skin and t further secure the attachment plate t the skin, apply an additinal medical hypallergenic drape (prvided by IVT Medical Ltd. as an accessry in TpClsure 1S, 1S-AD and 1S-M System packages). T further secure the system, it is advisable t circumferentially wrap it with an elastic bandage. Illustratin 1: TpClsure Nn-Invasive applicatin demnstratin in 4 steps. TpClsure Invasive Applicatin Nte: when applying the TpClsure invasively a pssibility f tissue scarring is inevitable. Befre applying the TpClsure invasively, evaluate the need Vs the cnsequences f this invasive applicatin. The care prvider shuld evaluate the amunt f stress that is anticipated during clsure f the wund and carefully judge wund suturing methds and materials prir t making decisin as t the applicatin f the apprpriate TpClsure and means f applicatin. Only CE r FDA APPROVED staples, sutures, KW and tapes shuld be applied. The TpClsure shuld be remved and replaced accrding t the surgen's judgment. Gently remve the staples / sutures frm the patient's skin. T release tensin, gently lift the tab f the LR/M and then withdraw Detach the attachment plates frm the patient's skin (when an additinal medical adhesive tape has been used- remve it first). Illustratin 2 demnstrates the applicatin f TpClsure in cnjunctin with staples, in 3 steps. Using TpClsure in cnjunctin with Staples r Sutures Open the blister using sterile technique and remve the attachment plates and apprximatin straps required fr the applicatin. Illustratin 2: TpClsure Invasive applicatin demnstratin in 3 steps. Apply n skin which has been shaven, cleansed with Isprpyl Alchl spnge and dried thrughly. Adjust the attachment plates t the skin surface by bending them This simulated illustratin is fr demnstratin nly. When applying the system invasively, a dressing must be placed underneath the strap. TpClsure as a tpical tensin-relief platfrm fr tensin sutures (TS) alng the designated hrizntal indentatins, as needed. Peel ff the paper cver frm the adhesive tape n the back f each attachment plate. Imprtant Nte: Skip this step fr patients with knwn allergy t adhesives r tapes. Heavy nyln TS (Syneture MONOSOF CN-290 Cutting needle 3/8 77 mm) can be applied t vercme high tensin clsure during stressrelaxatin. The TS can be inserted thrugh ne f the designated val hles in the attachment plate, gripping the deep subcutaneus tissue n bth Place the plates and attach them t the skin n bth sides f the wund. The plates shuld be lcated at a minimal distance f 1cm frm wund edges. Firmly adhere t skin. Use staples (Weck Visistat with 35 wide staples) r sutures (35 mm cutting needle) t secure the plates t the skin using the designated pairs f val penings n each plate. Insert the strap t the lcking/ release mechanism (LR/M) f ne plate and then t the remte plate. While inserting the strap thrugh the LR/M f the remte plate, be sure t press dwn n the prximal end f the plate t avid its detachment frm the skin. sides f the wund, and exiting thrugh the plate n the cunter side f the wund. The suture is then threaded thrugh the pening at the frnt f bth Apprximatin Plates fr firm, high tensin tightening f the subcutaneus tissue by stress-relaxatin. Using TpClsure in cnjunctin with Kirschner Wires (KW) Open the blister using sterile technique and remve the attachment plates and apprximatin straps required fr the applicatin. Apply n skin which has been shaven, cleansed with Isprpyl Alchl spnge and dried thrughly. Adjust the attachment plates t the skin surface by bending them alng the designated hrizntal indentatins, as needed.

3 Peel ff the paper cver frm the adhesive tape n the back f each Adjust the attachment plates t the skin surface by bending them alng the attachment plate. Imprtant Nte: Skip this step fr patients with designated hrizntal indentatins, as needed. knwn allergy t adhesives r tapes. Peel ff the cver paper frm the adhesive tape n the back f each Place the plates and attach them t the skin n bth sides f the attachment plate. Imprtant Nte: Skip this step fr patients with knwn lesin r wund. The plates shuld be lcated at a minimal distance allergy t adhesives r tapes. f 1cm frm wund edges. Place the plates and attach them t the skin n bth sides f the lesin r Firmly adhere t skin. wund. The plates shuld be lcated at a minimal distance f 1cm frm On bth skin edges, insert a 1.8 r 1.6mm K-Wire thrugh the wund edges. wund edges, int the designated hrizntal pening acrss the base Attach the attachment plates nn-invasively in accrdance with the f the attachment plate, and then back int the skin. directins utlined in the apprpriate sectin n Instructins fr Use. Apply additinal staples r sutures as abve if indicated. Place the silicne gel sheeting directly n the scar/lesin. Insert the strap t the lcking/release mechanism (LR/M) f ne plate and then t the remte plate. While inserting the strap thrugh the LR/M f the remte plate, be sure t press dwn n the prximal end f the plate t avid its detachment frm the skin. Tighten the apprximatin strap gradually t enable skin stretching fr reductin f wund edges' gap. Make sure that the apprximatin strap's wing is interfaced with the lcking/release mechanism f the first plate. Cut shrtly the apprximatin strap as clinically indicated and secure stump t the plate with a tape. The adhesive is extremely durable under shear frces, yet can be easily peeled ff when needed. In rder t prevent inadvertent peel f the plate frm the skin and t further secure the attachment plate t the skin, apply an additinal medical hypallergenic drape (prvided by IVT Medical Ltd. as an accessry in the TpClsure 1S & 1SM System packages). T further secure the system, it is advisable t circumferentially wrap it with an elastic bandage. The TpClsure shuld be remved and replaced accrding t the surgen's judgment. Gently remve the Kirschner wire frm the patient's skin. T release tensin, gently lift the tab f the LR/M and then withdraw Detach the attachment plates frm the patient's skin (when an additinal medical adhesive tape has been used- remve it first). Using TpClsure applicatin in cnjunctin with silicne gel sheeting. Indicated nly fr the patient wh has n knwn allergy t the adhesive and glue. (silicne gel sheeting nt included) Nte: ONLY CE r FDA APPROVED SILICONE GEL SHEETING SHOULD BE APPLIED. Open the blister using sterile technique and pick the attachment plates and apprximatin straps required fr the intended applicatin. Apply n skin which has been shaven, cleansed with Isprpyl Alchl spnge and dried thrughly. Insert the strap, abve the silicne gel sheeting, t the lcking/release mechanism f ne plate and then t the remte plate (see illustratin 2, steps 1, 2). While inserting the strap thrugh the LR/M f the remte plate, be sure t press dwn n the prximal end f the plate t avid its detachment frm the skin. Tighten the apprximatin strap gradually t enable the skin stretching (see illustratin 2, step 3). Make sure that the apprximatin strap's wing is interfaced with the lcking/ releasing mechanism f the first plate. Cut shrtly the apprximatin strap as clinically indicated and secure stump t the plate with a tape. The adhesive is extremely durable under shear frces, yet can be easily peeled ff when needed. In rder t prevent unintentinal peeling f the plate frm the skin and t further secure the distal end f the attachment plate t the skin use an additinal medical hypallergenic drape (prvided by IVT Medical Ltd. as an accessry in TpClsure 1S & 1SM System packages). T further secure the system, it is advisable t circumferentially wrap it with an elastic bandage. The TpClsure shuld be remved and replaced accrding t the surgen's judgment. T release tensin, gently lift the tab f the LR/M and then withdraw Detach the attachment plates frm the patient's skin (when an additinal medical adhesive tape has been used- remve it first). Remve the Silicne gel sheeting frm the patient's skin. Precautins and Warnings A "pinch test" may be emplyed as a rugh estimatin f the ptential effectiveness f the skin stretching technique. If the tissue desn t stretch at all n either side f the wund, the device may nt be helpful in advancing the skin edges. Devices which cme in cntact with bdily fluids may require special dispsal handling t prevent bilgical cntaminatin. The TpClsure is packaged and sterilized fr single use nly. D nt reuse, reprcess r re-sterilize. Reuse, reprcessing, r re-sterilizatin may

4 cmprmise the structural integrity f the device and/r lead t device failure which in turn may result in patient injury r illness. Als, reprcessing r re-sterilizatin f single use devices may create a risk f cntaminatin and/r cause patient infectin r crss- infectin, including, but nt limited t, the transmissin f infectius disease(s) frm ne patient t anther. The signs indicate that the device was used are an pen r damaged Blister package and/r an attachment plate missing its adhesive's cver. The develpment f pst trauma r pstperative edema may cause severe degradatin in adhesin quality, skin shearing, r skin blistering. As with all skin adhesive prducts, a small percentage f individuals may experience hyp-pigmentatin r hyper-pigmentatin fllwing remval. Applicatin f any surgical tape r medical adhesive may result in skin stripping upn remval. Excessive tensin applicatin may cause skin damage by shearing, skin blistering, r lss f adhesin. The TpClsure may be used when the patient is under lcal, reginal r general anesthetic, as the surgen judges apprpriate. When lcal anesthesia is the methd selected, the anesthetic slutin used shuld NOT cntain adrenalin r ther knwn vasactive agents. Prir t using the device, the wund shuld be prepared fr clsure using clinical practices knwn t supprt the healing prcess (e.g. debridement, freshening f skin edges, etc.). It is NOT advisable t undermine the skin edges beynd the psitin f the intra-dermal needles. The surrunding area t be perated upn shuld als be prepared using sterile antiseptic cleansing slutin, and shuld be apprpriately draped. The plyprpylene (PP) is chemically inert and des nt interact with electric r magnetic surces r instruments. Chemical liquids such as saps, detergents, alchls, disinfectants and ther chemicals may change the adhesive prperties f the adhesive at the underside f TpClsure attachment plates. The attachment surface fr TpClsure shuld be clean and dry fr ptimal perfrmance f the adhering tape. Pssible expsure t bdy fluids, cleansing liquids r wetting f the tape shuld be cnsidered prir and during clinical use t determine means f prper securing f the device t the skin. Where there is tissue edema, the device shuld be used with cautin. This device must be prescribed by a physician. The device shuld be handled after use as a ptentially cntaminated material; therefre it must be dispsed f and discarded accrdingly. Lcal Infectin Lcal skin infectin may cmplicate lcal irritatin caused by adhesives and may require remval f attachment plate and tpical r systemic treatment f lcal infectin. PRIOR TO USE SEE INSTRUCTIONS. Lcal Pigmentatin Changes FOR SINGLE PATIENT USE. and/r Scar frmatin In rare ccasins, the applicatin f adhesives, staples r sutures may result in severe skin irritatin, with permanent changes in lcal pigmentatin and/r scar frmatin. Excessive Tensin n Anchring Skin Applicatin f tensin n the anchring skin may result in excessive shear stress n the skin that may induce skin damage (blistering and/r scaring). Use the releasing mechanism knb t release the apprximatin strap in rder t reduce lcal tensin. When skin lss is extensive r when wund gap is large, the applicatin f staples, sutures, KW r a cmbinatin f anchring methds wuld be clinically justified, althugh lcal scarring r skin damage at the anchring site is expected. Adverse effects that culd pssibly result frm the use f this device include skin irritatin, change in pigmentatin, lcal infectin, blistering and scaring. In additin, it may nt always be pssible t primary clse the wund by the TpClsure. Manufacturer's Warrantee: Nn-cnfrming prducts will be replaced withut charge, as lng as the prduct has been handled in accrdance with the manufacturer's recmmendatins and instructins. Fr mre infrmatin visit Authrizatins: 1023 IMH Registratin N Obelis s.a Bulevard Général Wahis Brussels, BELGIUM Tel: +(32) Fax: +(32) E Mail: mail@belis.net Risks and Adverse Effects Sensitivity t Adhesives and/r Silicne Gel Sheeting Sensitivity t adhesives is nt cmmn when medical tapes are used. Upn appearance f lcal redness, itching r stinging sensatin, the attachment plate r silicne gel sheeting shuld be remved, the area shuld be washed using water and sap and the physician in-charge shuld be cnsulted. If needed, a new attachment plate may be relcated. Manufactured fr IVT Medical Ltd. 16 HaTidhar st., Ra'anana 43665, Israel 2010 IVT Medical Ltd. All Rights Reserved. Exp. Date: see prduct label.

5 Sterility guaranteed unless package is damaged r pened. Latex Free D nt re-sterilize. M-Leaflet-EU Rev. 008 Issued July. 2014