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2

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DESCRIPTION

CONTENTS

DESCRIPTION

3

Intended Application

3

WARNINGS

4

DESCRIPTION OF THE PRODUCTS

5

Terminology

5

Quantities and sizes

7

Recommended standard accessories

7

QUICK GUIDE

8

PHASE ONE 

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 INITIAL HEALING PERIOD

9

Avoid the following

9

Skin barrier use

9

Assembling the stabilizer

10

Emptying the ostomy bag

11

Replacing the skin barrier

11

REMOVING THE TURNBULL ADAPTOR

13

Turnbull adaptor removal

13

Ileum trimming

13

PHASE TWO 

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 FINAL HEALING

14

Ileum healing

14

Temporary lid use

14

PHASE THREE 

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 USING THE LID

15

Lid acclimatisation

15

Emptying the intestine

16

Cleaning

17

Schedule for using the lid

17

DISCOMFORT AND RISKS

18

Surgical and device risks

18

Functional risks

18

Remedies in case of leakage

18

MANUFACTURER

19

Address

19

Declaration of Conformity

19

Patents and Trademarks

19

INTENDED APPLICATION

Summary of Contents for TIES

Page 1: ...CARE MANUAL TIES Transcutaneous Implant Evacuation System ...

Page 2: ... ostomy bag 11 Replacing the skin barrier 11 REMOVING THE TURNBULL ADAPTOR 13 Turnbull adaptor removal 13 Ileum trimming 13 PHASE TWO FINAL HEALING 14 Ileum healing 14 Temporary lid use 14 PHASE THREE USING THE LID 15 Lid acclimatisation 15 Emptying the intestine 16 Cleaning 17 Schedule for using the lid 17 DISCOMFORT AND RISKS 18 Surgical and device risks 18 Functional risks 18 Remedies in case o...

Page 3: ...onal ileostomy continent ileostomy ileo rectal anastomosis or ileal pouch anal anastomosis Male or female 18 years or older CONTRAINDICATIONS Any clinically significant anatomical deviation abnormal baseline laboratory result which affects the patient s suitability or puts the patient at risk Severe illness which may put the patient at risk or may influence the result or affect the patient s abili...

Page 4: ...ng the implant and the surrounding skin and when using the accessories WARNING Avoid the use of a catheter If a catheter needs to be inserted always use a soft catheter and water soluble gel Be careful not to touch the inside of the implant cylinder and be very gentle when feeding the catheter into the intestine to avoid irritating the ileum tissue or disturbing the implant tissue integration WARN...

Page 5: ...strong tissue ingrowth Used during the first weeks to provide optimum ingrowth conditions by securing the ileum above the Port ILEUM SECURING DEVICE TURNBULL ADAPTOR The Stabilizer secures the implant and provides support above skin level during the ingrowth period The Stabilizer consists of a Spacer pair and a Locking Ring All Stabilizer components can be re used several times and withstand boili...

Page 6: ...ly The Lid is re usable and can be cleaned in the same way as the 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 LID TIES LID Comes as a pair and is used together with a Locking Ring LOCKING RING LOCKING RING SPACER SPACE...

Page 7: ...4 mm STABILIZER KIT CONTAINS 5 Spacer pairs 5 Locking Rings PRODUCT RECOMMENDED SIZE COMMENT Ostomy skin barrier 70 mm Matching the ostomy bag Ostomy bag 70 mm Matching the ostomy skin barrier Adhesive remover Spray or wipes Irrigation sleeve Disposable or Flushable Drainage Sleeve QUANTITIES AND SIZES RECOMMENDED STANDARD ACCESSORIES ...

Page 8: ...Stabilizer with a Spacer pair around the implant and use the Locking Ring The ostomy bag fits over the Stabilizer Bathe gently with tap water when cleaning do not rub Dry carefully Use the Lid only when the implant is completely healed Never twist push bend or pull the implant or the surrounding skin ...

Page 9: ...kin The protruding end of the intestine has been turned inside out on the Turnbull Adaptor on top of the implant and secured with a few sutures Cut out a 40 mm diameter hole in the ostomy skin barrier Best is to use a pair of curved scissors following the guiding pattern on the skin barrier Accurately centre the ostomy skin barrier with the cut out hole over and around the implant and fix it gentl...

Page 10: ...acers between the skin and the base of the cylinder top Hold the Spacer pair firmly with one hand Put on the Locking Ring line up the positioning indexes and carefully turn it clockwise with the other hand until the bayonet locks in place Do not rotate pull or push on the Spacer pair Place an ostomy bag over the implant and Stabilizer Gently seal the bag to the skin barrier fixing flange in the us...

Page 11: ...ant with lukewarm water as necessary Avoid the use of disinfectants During the first weeks it is advisable to leave the ostomy skin barrier in place as long as possible normally up to 7 days Use a protective skin cream or ointment to prevent skin irritation Early or frequent replacement of the skin barrier may disturb the ingrowth implant tissue integration Hold the Spacer pair firmly with one han...

Page 12: ...ently lift away the skin barrier and spray again as required on the skin under the skin barrier Carefully clean the area around the implant and the outside of the implant each time the skin barrier is replaced Use lukewarm water and mild soap as needed Ordinary tap water is sufficient Avoid the use of disinfectants Never rub or press on the skin surrounding the implant Dry completely using soft ba...

Page 13: ... without surgical intervention The intestine will reside permanently just at the top of the implant After another two weeks it is time to carefully trim off excess parts of the intestine in a simple daycare surgical procedure Alternatively your surgeon may choose not to actively trim off excess parts but rather wait a few more weeks for the wizening process to complete thus achieving a natural tri...

Page 14: ...gement of your doctor it is possible to start using the Lid momentarily During this period the Lid may be used occasionally for short periods up to an hour Before final healing is accomplished it is important to avoid any build up of intestinal pressure This is merely a training and habituation phase Be very observant in avoiding intestinal pressures or discomfort and swiftly remove the Lid in suc...

Page 15: ...an progress much faster for patients who already have a reservoir when the TIES Port is implanted When starting to use the Lid for extended periods a certain amount of discomfort can occur around the implant and in the abdomen This is fully normal and only shows that the intestine is adjusting and expanding If you experience pain in the abdomen the lid should be removed Contact the ostomy nurse or...

Page 16: ...lant and position the open end over the toilet Remove the Lid inside the sleeve Operate the Lid from the out side of the sleeve to avoid soiling of your hands Use only sufficient force to affix and to remove the Lid When the Lid has been removed the intestine can be emptied Bend slightly forward to empty all the contents and drain through the irrigation sleeve Should the emptying procedure require...

Page 17: ...or hygienic reasons PHASE THREE USING THE LID CLEANING SCHEDULE FOR USING THE LID In the beginning the Lid should be used for a limited time and a limited number of times during the day A personalised schedule for recommended Lid use shall be drawn up in collaboration with your physician During the acclimatisation period it is recommended to keep a diary in which you note the actual times and dura...

Page 18: ...mplete obstruction of the implant The implant may have to be removed Should a recurrence of Crohn s disease occur it is not advised to replace the implant It should be removed and a conventional ileostomy should be done SURGICAL AND DEVICE RISKS FUNCTIONAL RISKS REMEDIES IN CASE OF LEAKAGE Potential discomforts and risks regarding the functional performance of the device related to the embedding o...

Page 19: ...ive 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 Any modification to the device not authorized by us will invalidate this declaration Benedict Brönnimann MD CEO OstomyCure AS Oslo 2016 06 17 0344 TIES is a brand name registered to OstomyCure AS Norway The TIES system is internationally...

Page 20: ... 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 ...

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