Herderstraße 5-9 • D-90427 Nürnberg • GermanyTel.: +49 9 11 / 7 90 88 06 • Fax: +49 9 11 / 79 23 37

www.medsse.de • info@medsse.de

Product information /Assortment range

Pharma-Central-no. (PZN) 853 856 1

Aid number 15.25.17.0001

0197

Only Med SSE offers individual problem solutions!

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Before we introduce our products for „fecal incontinence“, we would like to offer you a short „guideline“:

• ProblemFecal incontinence - You are not able to control your sphincter muscle, congenitally (Spina bifida,anal atresia with successive creation of an intestinal channel), or occurred through diabetes, para-plegia, MS, operation damages, (e.g. childbirth, haemorrhoids) after radiation therapy and due toage.

• SolutionThe PVA-anal tampon offers an anatomically adequate pressure-free closure of the anal canal.Beyond that the tampon is more than protection for your clothes, it is invisible and prevents odour.Application is also adequate for bedsore prevention.

• ProductA medical aid, certified according to the guidelines of medicinal law, made of polyvinyl alcohol(PVA) - foam. The foam is toxicologically and dermatologically harmless, and immunologically inac-tive. This is proven by qualified expert opinions.Different shapes and sizes up to individual production are adequate for achieving the "fitting pres-sure-free" closure for the intestinal canal geometries. Due to the unique special processing of thefoam, goblet-like micro pores are formed on the surface of the tampon. The product advantageachieved through the suction-cup-like character provides good sealing and holding function.

• ResultAffected people retrieve life quality, become mobile again, and can integrate themselves.Further, a large psychological strain is eliminated.School, studies, job, household (e. g. grocery shopping) can be done again without limitations.Affected people can enjoy leisure activities like sports (even swimming), theatre, cinema againblithely.

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• Prescription/ProcurementProcure the prescription from the physician. The physician should prescribe a starter assortment. Either send the prescription to Med SSE. Med SSE has the prescription authorized by the health insurance.After authorization, Med SSE sends the starter assortment. (Further explanations concerning the starter assortment see page 5)Or take the prescription to the pharmacy/sanitary store.

• Size determination

Affected people determine the right size without time pressure and with sufficient care (always start with small sizes). When the fitting size is selected, send the unused tampons back to Med SSE. Med SSE exchanges the same quantity for the fitting size(s). Conduct subsequent orders in the desired size.

If the therapy is not successful, contrary to expectation, Med SSE takes the unused tam-pons back with corresponding repayment of the costs.

• CostsThe PVA-anal tampons are approved as medial aid product by the German Insurance Associationof Health Insurances. The costs are paid by the health insurance upon corresponding indication.Where required, co-payment (deductible) must be made. This means incontinence treatment isgiven with at the most 10,- W per month.

• ApplicationIllustrated by graphics step by step in the instruction manual. (see page 8).

• HygieneAnal-hygiene is an essential measure for the maintenance of health. For round-the-clock care thisincludes 3 changes of the tampon, careful cleaning of the anal area from the outside (lukewarmwater with mild suds, disposable gloves), good drying and possibly the application of lotion. Avoidinjuries through fingernails or other hard objects during cleaning. In case of problems, please con-sult the treating physician.

Only Med SSE offers individual problem solutions!

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! !

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Tampon Cylindrical

Application if there is still remaining function of the sphincter muscle, but sea-ling and holding function is not guaranteed due to weakness.

Art.-no. Diameter/Length*2103 1) 10 mm, 30 mm shortened2123 1) 12 mm, 30 mm shortened2153 1) 15 mm, 37 mm shortened2180 18 mm, 67 mm2181 18 mm, 60 mm shortened2182 1) 18 mm, 47 mm shortened2183 1) 18 mm, 37 mm shortened2200 20 mm, 67 mm2201 20 mm, 60 mm shortened2202 1) 20 mm, 51 mm shortened2203 1) 20 mm, 40 mm shortened2220 22 mm, 67 mm2221 22 mm, 60 mm shortened2222 1) 22 mm, 51 mm shortened2240 24 mm, 67 mm2241 24 mm, 60 mm shortened

Art.-no. Diameter/Length*2260 26 mm, 67 mm2261 26 mm, 60 mm shortened2262 1) 26 mm, 51 mm shortened2280 28 mm, 67 mm2281 1) 28 mm, 60 mm shortened2291 1) 29 mm, 60 mm shortened2300 30 mm, 67 mm2301 38 mm, 60 mm shortened2302 1) 30 mm, 51 mm shortened2303 1) 28 mm, SSE with magnet (10)2330 33 mm, 67 mm2332 1) 33 mm, 45 mm shortened2380 38 mm, 67 mm2400 1) 40 mm, 67 mm2405 1) 40 mm, 102 mm2450 1) 45 mm, 67 mm

Tampon Spiral with specially corrugated surface structure

Provides ideal hold in case of minor to medium diarrhoea due to corrugatedsurface structure. Accumulating excessive gas is diverted through the riffleson the surface.

Art.-no. Diameter/Length*0220 22 mm, 64 mm0260 26 mm, 64 mm0263 1) 26 mm, 44 mm shortened0330 33 mm, 64 mm

Tampon Concave

Application for convex formation (normal anatomy) of the sphincter muscle.The tapered shape provides good sealing and holding function.

Art.-no. Diameter/Length*1160 16 mm, 67 mm1161 16 mm, 60 mm shortened1162 16 mm, 51 mm shortened1164 1) 16 mm, 40 mm shortened1180 18 mm, 67 mm1181 18 mm, 60 mm shortened1200 20 mm, 67 mm1201 20 mm, 60 mm shortened

Art.-no. Diameter/Length*1202 1) 20 mm, 51 mm shortened1250 25 mm, 67 mm1251 1) 25 mm, 60 mm shortened1280 28 mm, 67 mm1281 1) 28 mm, 60 mm shortened1300 30 mm, 67 mm1350 1) 35 mm, 67 mm

Tampon Cone

Closes the straight intestine like a ball valve, seals off the anal canal throughthe bulge in the middle, and ideally adapts to the anatomy due to the tapering.

Art.-no. Length* Diameter* Tip/middle1636 83 mm 30/ 36 mm 1628 67 mm 26/ 32 mm

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Tampon Ball

Application for no remaining function of the muscle tissue. The ball-shaped tipseals the area where the faeces collects (Ampulla recti) similar to a ball valve.

Art.-no. Diameter/Length*3103 1) 10 mm, 40 mm shortened3123 1) 12 mm, 49 mm shortened3150 15 mm, 60 mm shortened3180 18 mm, 60 mm shortened3182 1) 18 mm, 40 mm shortened3200 20 mm, 60 mm shortened

Art.-no. Diameter/Length*3203 1) 20 mm, 40 mm shortened3220 22 mm, 60 mm shortened3222 1) 22 mm, 51 mm shortened3240 24 mm, 60 mm shortened3280 28 mm, 67 mm3300 30 mm, 67 mm

Tampon ConvexThis shape prevents uncontrolled bowel movement, activates the sphinctermuscle in case of existing remaining function. The convex shaped tampon isalso used for strongly receded muscle tissue.

Art.-no. Diameter/Length*3020 24 mm, 51 mm shortened3030 33 mm, 60 mm shortened

• Explanations to the starter assortmentThe starter assortment is available for children (up to 8 years), youth (up to 18 years), and adults. The experience of over 20 years has shown that the preliminary assortment of Med SSE very fre quently facilitates the selection of the fitting shape / size. The content of a starter assortment is 100 tampons, packaged in 5 piece resp. 10 piece units of the most common kinds. You now have the opportunity to select the right shape / size without time pressure.

With the starter assortment for anal atresia patients we have developed a unit that considersparticularly small sizes. The package content is 50 tampons, pre-sorted in 5-piece resp.10-piece units.

As the tampons are single packaged, we take back the content of the begun 5- piece or 10 pieceunit as a matter of course.

Should a determination of size already have taken place during the physicians examination, wealso deliver individually composed starter assortments.

Only Med SSE offers individual problem solutions!

www.medsse.de

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Tampon Proctology

Is used in the past-operative phase (haemorrhoids, plastic reconstruction ofthe anal canal etc.).

*The length and diameter indications are approximate values in the condition of use (moist). The raw material (polyvinyl alcohol-foam) is an elastic material that may have minor deviations.

Upon inquiry, oversizes, and special sizes with equally best product characteristics are pos-sible for almost all shapes!

Art.-no. Diameter/Length*4100 26 mm, 67 mm4150 26 mm, 67 mm, with drainage4330 33 mm, 67 mm

Applikatoren

For better insertion of the tampon soft in moistcondition but instable.

Art.-Nr. Shape7100 small7200 large

Anal securing aid

Additional securing aid in order to prevent the tam-pon from sliding out, applicable for mobile affectedpeople (e.g. wheelchair sports).

Art.-no. Shape7400 round7401 oval7405 infinite

self-adhesive throughlatex-free glue

1) Special design, these are excluded from replacement. Approximately 1 week delivery time must be considered for the disposition.

Incontinence articles, like for example , are cert-fied medical aids.

There is no budgeting for the aids according to the 1. and 2. GKV-Neu-ordnungsgesetz (public health insurance new order law).Aids remain obligatory performance of the public health insurance.

A separate prescription always needs to be prepared for aids (usuallythe field 7 and „fee required” is to be marked). If aids are prescribedon a prescription with medicine, surgical dressings, or medicinal sub-stances, they strain the budget. With a separate prescription, there is no risk of balance paymentaccording to Art. 29 GSG.

The prescription should contain:

• Indication (symptoms) in order to secure the cost repayment throughthe insurance. For the first prescription it is recommended to supportthe approval with an attestation!

or

• „Enablement of participation in social life”. (Socialwelfare court Gießen Az:5-9/Kv 364/87)

• Product Description

• Size/Shape

• Quantity

• Aid number 15.25.17.0001

Useful indications for the physicianExample for incontinence-aid-prescription

AOK

Mustermann

Muster Weg

16

12345 Muster

hausen

8814113 060

7567802 1 0

00 1

489594711

02/08

PVA-anal tam

pon starter

assortment,1

00 pieces

Applicator

large, 1 pi

ece

Applicator

small, 1 pi

ece

Diagnosis:

Model

In case of questions

please contact us

free of charge

0800 / 0 63 37 73

Prescription proposal for first prescription:

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Instruction Manual

4Pull the removal cord out of theinner borehole.

5Soak the plug with warmwater for a short time.

6Press out surplus water.Do not wring!

7Stick the inner borehole of the plugon the thorn of the applicator. Ifnecessary, Vaseline can be appliedon the tip of the plug in order to allowfor better sliding.

8With the applicator, insert the pluginto the intestinal tract in a waythat the removal cord is visible(see illustration).

9When you pull out the applicatorpress the bottom cheeks againsteach other.

10With an adhesive plaster stick theremoval cord to the bottom cheek.Use the anal protection, ifnecessary.

11Wash the hands thoroughly afterinsertion of the plug.

12Remove plug with the removalcord and dispose with house-hold waste, not via the toilet!

1Wash hands with water and soap.

2Clean the anal area thoroughly.

3Remove the protective film.

Please, also read our additional advice/recommendations.When you insert the plug, please follow the instructions that are described and illustrated in the following. Proceeding issimilar to the insertion of a suppository. The plugs are designed for single use. The insertion aid (applicator) can beused several times.

07/ 16

Advice/Recommendations• Clear your bowels before you insert the plug.• By toilet training, make the bowel get used to constant evacuation times.• For initial use start with small sizes.• As the case may be, put Vaseline on the thorn of the applicator for easy release.• Await the contraction reflex (approx. 15 to 20 seconds).***• Remove plug after 6 to 8 hours maximum.• By pulling the removal cord the plug is removed from the intestinal tract.• In case the removal cord breaks when you remove the plug, despite permanent controls, and you

cannot pull out the plug due to that, we ask you to see your doctor.• For further orders, please send a respective prescription from your doctor to Med.SSE.• Use our free service number in case of further questions 0800/0633773.

*** This reflex will stop after an customisation period of approx. 5 to 6 weeks.