MIC Introducer Kit - Vygon (UK)

MIC Introducer KitGastropexy madeSafe, Simple & EffectiveFeatures and BenefitsPrimary Placement of a Balloon DeviceWith the MIC Introducer Kit you can safely place a balloon device during the initial placementprocedure. Traditional gastrostomy placement techniques involve an initial procedure to place aPEG tube, which stays in place while the stoma forms, and is then replaced with a balloon device.The unique SAF-T-PEXY T-Fasteners secure the stoma and can safely remain in situ until the stomahas become properly established. This reduces the number of procedures, eliminating associatedcosts and minimising patient discomfort.Convenient Procedure PackThe MIC Introducer Kit includes all the components required to perform a gastropexy procedure,presented in a single sterile pack. This saves time, and gives you peace of mind that you haveeverything to hand at the start of the procedure, with only the balloon device to be addedonce the stoma site has been measured. Having all the required components in a single sterilepack also reduces the risk of cross-contamination associated with opening multiple packs, andreduces your ordering and stock holding costs.2Vygon UK Ltd | MIC Introducer KitVygon UK Ltd | MIC Introducer Kit3

MIC Introducer KitGastropexy madeSafe, Simple & EffectiveFeatures and BenefitsThe MIC Introducer Kit contains four individual introducer needles thatare pre-loaded with SAF-T-PEXY T-Fasteners, reducing the time takento perform the procedure.Each introducer needle has a built-in safety mechanism that covers theneedle tip once the T-Fastener has been deployed, reducing the risk ofclinician or patient injury.The use of individual needles reduces the risks of infection associatedwith crossing the peritoneal cavity repeatedly with the same needle atdifferent sites.Pre-Loaded SAF-T-PEXY NeedlesUnique Locking DiscSAF-T-PEXY T-Fastener4 Vygon UK Ltd | MIC Introducer KitThe T-Fastener sutures feature unique locking discs that are quick to fixin place, leaving a securely held suture.This design allows easy cleaning of the gastropexy site, whichsignificantly reduces the risk of infection, and the smooth, roundedbase offers a major improvement in patient comfort.The locking discs then fall away once the suture has been absorbed.The SAF-T-PEXY T-Fastener sutures are designed to remain in situ for2-3 weeks before being absorbed by the body once the gastropexyadhesion has fully developed.This makes gastropexy a more reliable technique, and improves patientcomfort during stoma formation.Safety ScalpelSAF-T-PEXYSafetyIntroducerNeedleSingle Serial DilatorThe new single serial dilator features all dilation stages in a single device,you simply feed each dilator stage over the previous one until the stomasite is correctly sized.This saves you time during the procedure, and removes the need to rethreadeach dilator stage over a guidewire, reducing the risk of infection.Made to MeasureWhen placing a MIC-KEY button gastrostomy or transgastricjejunostomy device you need to measure the stoma length duringdilation.The serial dilator features a red-coloured stage to indicate that thestoma is large enough to accept the measuring device.The dilator is simply removed once the red stage has been inserted,then replaced after stoma measurement so dilation can continue.Sharps SafetySharps safety is an important concern for all, and this has beenincorporated as standard into the MIC Introducer Kit.All needles have built-in safety mechanisms, and a safety scalpel isincluded to reduce the risk of injury.Vygon UK Ltd | MIC Introducer Kit5

MIC Introducer KitGastropexy madeSafe, Simple & EffectiveSuggested Procedure12 31011 12Mark the insertion site withPrime the SAF-T-PEXY introducersPull back the blue clip and pushGradually insert the next dilatorOptional when measurement isOnce the measurement is taken,introducer points in a triangle at 2cmwith sterile water and insert at thethe clear hub down to eject thestages, using a clockwise/counterrequired, remove the dilator, applyre-insert the serial dilator andaway from the stoma site. Infiltratepoints marked.T-Fastener.clockwise twisting motion, stoppinglubricant to the tip of the measuringcontinue the dilation up to thewith local anaesthetic.after the red stage when you needdevice and insert over wire. Takelargest stage (peelable sheath).to use a measuring device.measurement from above disc.4 561314 15Slide the locking disc to the skin butPull the sutures up until resistance isAnaesthetise the stoma site, makeTwist the hub to release the dilatorInspect the gastrostomy balloonAdvance the feeding tube as youdo not lock. Secure sutures with afelt (the T-Fasteners will be againstan incision using the safety scalpelfrom the peelable sheath. Lubricatethen ensure it is fully deflated.peel and remove the sheath. Oncehaemostat until all are introduced.the stomach wall) then slide lockingthrough the abdominal wall.the exterior of the sheath andLubricate the tip, then insert thethe sheath is fully removed, makediscs down to skin level,lock inadvance into the stomach, thentube into the peelable sheath andsure that the feeding tube is fullyposition with an audible click and cutremove the dilator.begin to peel apart.inserted and inflate the balloon withsutures to length.the correct amount of water.7 8916ImportantThe sutures will be absorbed in approximately 3 weeks, atwhich point the locking discs will fall away.Insert the 18G safety introducerneedle at the stoma site, then insertthe guidewire.Remove the introducer needle,sliding the pink section down tocover the needle tip as you withdraw.For TJ placement, the seekingcatheter may be used to facilitateplacement.Apply a water-soluble lubricant.Thread the serial dilator over theguidewire then insert the smallestdilator stage into the stoma, twistingas you advance into the stoma.Keep the site clean, and observe forany signs of irritation or leakage. Do notrotate the gastrostomy.Do not rotate the feeding tube during the first two weeksafter placement.Only use water-soluble lubricants.For full procedure please refer to instructions for use.6 Vygon UK Ltd | MIC Introducer Kit Vygon UK Ltd | MIC Introducer Kit7

MIC Introducer KitGastropexy madeSafe, Simple & EffectiveMIC-KEY G and TJ Introducer KitMIC-KEY Low-Profile Gastrostomy Introducer KitComplete kit for primary placement of a MIC-KEY gastrostomy button.(MIC120 and MIC2120 ranges)For use withMIC-KEY Low-Profile Transgastric-Jejunal Double LumenIntroducer KitComplete kit for primary placement of a MIC-KEY transgastric jejunal button.(MIC270 range)For use withMIC-KEY GastrostomyMIC-KEY TJButton supplied separatelyButton suppliedseparatelyProductCodeMIC98430MIC98431MIC98432Product Description For use with Box/CaseQuantityMIC-KEY 12FrMIC-KEY G - 12Fr Introducer KitLow-profile GastrostomyIncludes 16Fr DilatorFeeding Tube*1 Kit/CaseMIC-KEY 14FrMIC-KEY G - 14Fr Introducer KitLow-profile GastrostomyIncludes 18Fr DilatorFeeding Tube*1 Kit/CaseMIC-KEY 16FrMIC-KEY G - 16Fr Introducer KitLow-profile GastrostomyIncludes 20Fr DilatorFeeding Tube*1 Kit/CaseKit Contents4 x SAF-T-PEXY T-Fasteners1 x Haemostat1 x 18G safety introducer needle1 x 0.35" J-tip guidewire1 x N o 11 safety scalpel1 x Serial dilator1 x Over-the-wire stoma measuringdeviceProductCodeMIC98437MIC98438Product Description For use with Box/CaseQuantityMIC-KEY 16FrMIC-KEY TJ - 16Fr Introducer Kit Low-profileIncludes 20Fr DilatorTransgastric Jejunal1 Kit/CaseFeeding Tube*MIC-KEY 18FrMIC-KEY TJ - 18Fr Introducer Kit Low-profileIncludes 22Fr DilatorTransgastric Jejunal1 Kit/CaseFeeding Tube*Kit Contents4 x SAF-T-PEXY T-Fasteners1 x Haemostat1 x 18G safety introducer needle1 x 5Fr seeking catheter, compatiblewith a 0.38" guidewire1 x N o 11 safety scalpel1 x Serial dilatorMIC98433MIC-KEY G - 18Fr Introducer KitIncludes 22Fr DilatorMIC-KEY 18FrLow-profile GastrostomyFeeding Tube**1 Kit/Case2 x 12ml syringes* Tube not included1 x Over-the-wire stoma measuringdevice2 x 12ml syringesMIC98434MIC-KEY G - 20Fr Introducer KitIncludes 24Fr DilatorMIC-KEY 20FrLow-profile GastrostomyFeeding Tube*1 Kit/Case* Tube not included16Fr Serial18Fr Serial20Fr Serial22Fr Serial24Fr Serial20Fr Serial22Fr SerialDilatorDilatorDilatorDilatorDilatorDilatorDilator8Vygon UK Ltd | MIC Introducer KitVygon UK Ltd | MIC Introducer Kit9

MIC Introducer KitGastropexy madeSafe, Simple & EffectiveMIC G and TJ Introducer KitsMIC Gastrostomy Introducer KitComplete kit for primary placement of a MIC gastrostomy tube.(MIC100, MIC110 and 2371 range)MIC Transgastric-Jejunal Double Lumen Introducer KitComplete kit for primary placement of a MIC transgastric jejunal tube.(MIC650 range)For use withFor use withMIC G Tubesupplied separatelyProductCodeProduct Description For use with Box/CaseQuantityKit Contents4 x SAF-T-PEXY T-FastenersProductCodeProduct Description For use with Box/CaseQuantityKit ContentsMIC98420MIC G - 12Fr Introducer KitIncludes 16Fr DilatorMIC-KEY 12FrGastrostomy Feeding Tube*1 Kit/Case1 x Haemostat1 x 18G safety introducer needleMIC98435MIC TJ - 16Fr Introducer KitIncludes 20Fr DilatorMIC 16Fr TransgastricJejunal Feeding Tube*1 Kit/Case4 x SAF-T-PEXY T-Fasteners1 x HaemostatMIC98421MIC98422MIC G - 14Fr Introducer KitIncludes 18Fr DilatorMIC G - 16Fr Introducer KitIncludes 20Fr DilatorMIC-KEY 14FrGastrostomy Feeding Tube*MIC-KEY 16FrGastrostomy Feeding Tube*1 Kit/Case1 Kit/Case1 x 0.35" J-tip guidewire1 x N o 11 safety scalpel1 x Serial dilator1 x 12ml syringeMIC TJ - 18Fr Introducer KitMIC98436Includes 22Fr Dilator* Tube not includedMIC 18Fr TransgastricJejunal Feeding Tube*1 Kit/Case1 x 18G safety introducer needle1 x 5Fr seeking catheter, compatiblewith a 0.38" guidewire1 x N o 11 safety scalpel1 x Serial dilator1 x 12ml syringeMIC98423MIC G - 18Fr Introducer KitIncludes 22Fr DilatorMIC-KEY 18FrGastrostomy Feeding Tube*1 Kit/CaseMIC98424MIC G - 20Fr Introducer KitIncludes 24Fr DilatorMIC-KEY 20FrGastrostomy Feeding Tube*1 Kit/Case* Tube not included16Fr SerialDilator18Fr SerialDilator20Fr SerialDilator22Fr SerialDilator24Fr SerialDilator20Fr SerialDilator22Fr SerialDilatorVygon UK Ltd | MIC Introducer Kit10Vygon UK Ltd | MIC Introducer Kit11

MIC Introducer KitGastropexy madeSafe, Simple & EffectiveProduct SupportTraining and SupportVygon puts customer service first in everything we do. Inorder to help you meet “Best Practice” requirements, weoffer a number of support services as standard. Theseservices include:From Our Post-Insertion Care GuideCare of the SiteYou will notice your gastrostomy tube on your stomach in the middle of two, three orfour small discs.These discs lock in place a suture that secures your stomach to the inside of yourabdomen. After 2-3 weeks these suture locks will have done their job and will start tofall off.MIC Introducer Kit• In-service product training which can be tailored to match your local policies and protocols.• Patient information leaflets that can be customised to reflect your local practice.• Access to our Technical Support Department, which handles technicalenquiries about products, procedural advice and regulatory device issues.• Customised posters reflecting your NHS Trust’s policies and protocols topromote current practice guidelines.• Local workshops for specific requirements, withguest speakers, to reinforce the message toyour teams.GastrostomyStudy DaysVygon also organises anumber of gastrostomystudy days around thecountry. These are fundedby an educational grant,with all proceeds from thesmall registration fee goingto our nominated charityPINNT. Delegates spend theday hearing guest speakersfrom the field of gastrostomyplacement and care, and takepart in hands-on workshops. Thestudy days provide an ideal forum forgroup discussion of local practices, andan opportunity to make contacts in yourlocal area.12Vygon UK Ltd | MIC Introducer KitIf the suture lock does not fall off in the suggested time, your doctor or nurse maycut the suture.Inspect the stoma and suture lock sites daily and assess for any signs of infection.Notify your doctor or nurse of any of the following;• Redness• Irritation• Oedema (bruising)• Swelling• Tenderness• Warmth• Rash• Purulent or gastrointestinal dischargeAssess for any signs of pain, pressure or discomfort.It is important to keep the stoma site and suture lock sites clean.Routine care should include cleaning the skin around the stoma and suture lock sites with warm water and mildsoap followed by thorough rinsing and drying. A cotton bud is ideal for cleaning under the suture lock.CAUTIONSThe suture locks (discs) may pose a choking hazard. Ensure that children do not attempt to swallowthe discs.DO NOT rotate the suture locks, this may weaken the suture and cause early detachment.DO NOT rotate the gastrostomy tube for the first two weeks after placement. Do not rotate agastro-jejunal tube at any time.www.vygon.comMIC Introducer Kit Care Guide LeafletAvailable to order, code: PS165Vygon UK Ltd | MIC Introducer Kit13

This brochure has been printed using environmentally-friendly processes, onpaper from well-managed sources, and can be recycled. If you would like toreceive an electronic copy, please contact the Vygon Customer Services teamon 01285 657051.Vygon (UK) LtdWeb: www.vygon.co.ukEmail: vygon@vygon.co.uk0061.MIC.INTRO Content correct as of 11/2010