OstomyCure TIES Care Manual

Transcutaneous implant evacuation system

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CARE MANUAL

TIES®

Transcutaneous Implant Evacuation System

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Summary of Contents for OstomyCure TIES

Page 1 CARE MANUAL TIES® Transcutaneous Implant Evacuation System...
Page 2: Table Of Contents
CONTENTS DESCRIPTION Intended Application WARNINGS DESCRIPTION OF THE PRODUCTS Terminology Quantities and sizes Recommended standard accessories QUICK GUIDE PHASE ONE | INITIAL HEALING PERIOD Avoid the following Skin barrier use Assembling the stabilizer Emptying the ostomy bag Replacing the skin barrier REMOVING THE TURNBULL ADAPTOR Turnbull adaptor removal Ileum trimming...
Page 3: Description
DESCRIPTION The Transcutaneous Implant Evacuation System (TIES®) is a complete method for providing a continent ileostomy for the treatment of inflammatory, autoimmune or tumour intestinal diseases. The TIES® system intends to provide a permanent, patient-controlled continent stoma that obviates the need to wear a bag after removal of the large intestine.
Page 4: Warnings
WARNINGS Follow all warnings and caution statements. If the system is to function as intended, the healing time and associated instructions must be complied with. WARNING! The implant needs time to heal as it grows firmly into the correct position. Avoid continuous and sudden loads that could affect the implant and the surrounding skin.
Page 5: Description Of The Products
DESCRIPTION OF THE PRODUCTS TERMINOLOGY TIES® (Transcutaneous Implant Evacuation System) is intended to create a continent stoma using an implant, the TIES® Port, and associated lid, the TIES® Lid. IMPLANT, TIES® PORT The round section protruding through the skin provides stable attachment for the Lid and is easy to keep clean.
Page 6 Stabilizer. Replace the Lid every week. Always check the outside of the packaging for any damage. If the packaging has been damaged the product must not be used. Contact your clinic or OstomyCure if any item is missing or damaged.
Page 7: Quantities And Sizes
DESCRIPTION OF THE PRODUCTS QUANTITIES AND SIZES TIES® Port system is summarised in the table below. IMPLANT INNER DIAMETER OUTER DIAMETER STABILIZER KIT CONTAINS 23,2 mm 28,4 mm 5 Spacer pairs 5 Locking Rings RECOMMENDED STANDARD ACCESSORIES PRODUCT RECOMMENDED SIZE...
Page 8: Quick Guide
QUICK GUIDE Cut a 40 mm hole and centre the skin barrier around the implant. Assemble the Stabilizer with a Spacer pair around the implant and use the Locking Ring. The ostomy bag fits Bathe gently with tap water when cleaning, do not rub. Dry over the Stabilizer.
Page 9: Phase One | Initial Healing Period
PHASE ONE | INITIAL HEALING PERIOD AVOID THE FOLLOWING Never twist, push, bend or pull the implant or the surrounding skin! This is very important to prevent disturbing the ingrowth. SKIN BARRIER USE • The ostomy skin barrier must be affixed to clean and dry skin.
Page 10: Assembling The Stabilizer
PHASE ONE | INITIAL HEALING PERIOD ASSEMBLING THE STABILIZER • Place two Spacers on the skin barrier around the implant. Align an arrow on the Spacer pair to an arrow on the Turnbull Adaptor and gently press the Spacer pair together, locking into the groove on the implant just below the Turnbull Adaptor.
Page 11: Emptying The Ostomy Bag
PHASE ONE | INITIAL HEALING PERIOD EMPTYING THE OSTOMY BAG • The length of time between draining or replacing the ostomy bag varies from person to person, but it normally needs to be emptied 2 - 5 times a day. When removing and replacing the bag, take great care and work only against the fixing flange on the skin barrier.
Page 12 PHASE ONE | INITIAL HEALING PERIOD REPLACING THE SKIN BARRIER (continued) • Carefully lift a corner of the ostomy skin barrier. Hold a dampened, nonwoven swab gently against the skin right next to the skin barrier. • Do not pull or stretch the skin near the implant, as this may affect healing. •...
Page 13: Removing The Turnbull Adaptor
REMOVING THE TURNBULL ADAPTOR TURNBULL ADAPTOR REMOVAL After three to four weeks the intestine has grown enough into the implant and the Turnbull Adaptor may be removed. The very end of the intestine protruding outside the implant has now started to wizen and the sutures are coming loose.
Page 14: Phase Two | Final Healing
PHASE TWO | FINAL HEALING The time for final healing varies between individuals but is expected to be in the range of two to three weeks after trimming (two to three months after Port implantation). It is recommended to use an ostomy skin barrier and an ostomy bag during this time. The Lid must not be used permanently before final healing is completed! ILEUM HEALING After the final trimming, the ileum will need approximately two weeks for healing and rest.
Page 15: Phase Three | Using The Lid
This reservoir means that the intestinal contents do not need to be emptied as often. Expect several months for this process to be fully completed. Lid acclimatisation can progress much faster for patients who already have a reservoir when the TIES® Port is implanted.
Page 16: Emptying The Intestine
PHASE THREE | USING THE LID EMPTYING THE INTESTINE The length of time between emptying the intestine varies from person to person, but it normally needs to be emptied two to ten times a day. For quick procedures, an irrigation sleeve is recommended. Affix the irrigation sleeve around the implant and position the open end over the toilet.
Page 17: Cleaning
PHASE THREE | USING THE LID CLEANING After each emptying, clean the outside of the implant, the surrounding skin (see PHASE ONE / REPLACING THE SKIN BARRIER) and the Lid using lukewarm running water if available. Avoid the use of disinfectants. Once the Lid is in continuous use, it should be replaced every week for hygienic reasons.
Page 18: Discomfort And Risks
DISCOMFORTS AND RISKS SURGICAL AND DEVICE RISKS Potential discomforts and risks, originating from the surgical procedure or the TIES device itself. • Redness at the operation site • Pain • Allergic reaction (including to medications, anaesthesia or device materials) •...
Page 19: Manufacturer
OstomyCure AS certifies the compliance with the EC Directive 93/42/EEC (Medical Device Directive, MDD) of June 14, 1993. We declare that the compliance of the TIES® system conforms to the essential requirements of the MDD regarding medical devices per annex II.
Page 20 Contact information OstomyCure AS | Gaustadalléen 21 | N-0349 OSLO | NORWAY Stockholm office | Isafjordsgatan 39B | SE-164 40 KISTA | SWEDEN Fax: +46 8 752 99 00 | e-mail: info@ostomycure.com | www.ostomycure.com 32-5TF12026-07 TIES® Care Manual EN, 2016-DEC-23...