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The conformity of the ALFA-Flex and BETA-Flex foot abduction orthoses from Semeda is confirmed by the CE mark. The

current version of the EU declaration of conformity can be requested from Semeda at any time. For orthopaedic tech

nicians, the declaration of conformity is available for download at www.semeda.de under the section english/download/

technicians.

5. Assembly instructions

Содержание ALFA-Flex

Страница 1: ...Semeda GmbH Am Petersberg 36 29389 Bad Bodenteich TL 3001 002 ALFA Flex BETA Flex Foot Abduction Orthosis Usage Instructions EN ...

Страница 2: ...1 2 9 Training or specific qualifications of the product user 11 2 10 Decommissioning 11 2 11 Reporting serious incidents 11 3 Addresses 11 3 1 Manufacturer name address contact details 11 4 Performance data 12 4 1 Technical specifications of the ALFA Flex foot abduction orthosis 12 4 1 1 Specific properties of the ALFA Flex Brace foot abduction splint ALFA Flex XL Brace foot abduction splint 12 4...

Страница 3: ...t with the foot supports each time you put on your orthosis Make sure that your foot is correctly and firmly seated in the foot support otherwise pres sure marks blisters and redness may occur Your foot supports should be aired twice a day for 30 minutes If your feet perspire heavily change your socks several times a day Check at regular intervals that the screws on the splint do not loosen The fo...

Страница 4: ...Please do not use any harsh cleaning agents as these can attack the plastic and the leather Safe fitting of the ALFA Flex Brace and BETA Flex Brace foot abduction splint can and must only be carried out by the fitting orthopaedic shoemaker or orthopaedic technician Please do not change adjust the settings of the ALFA Flex Brace and BETA Flex Brace foot abduction splint yourself as this could lead ...

Страница 5: ...uction splint Foot support 1 2 3 Foot support The respective foot support is used to immobilise the child s feet that are to be treated It is connected to the brace by means of a click fastener 1 2 4 The AFLA Flex Brace foot abduction splint ALFA Flex XL Brace foot abduction splint The AFLA Flex Brace foot abduction splint and the ALFA Flex XL Brace foot abduction splint are considered together he...

Страница 6: ...ilises the feet in an abduction angle that can be adjusted between 0 and 70 the dorsal extension is fixed in the therapeutic range of 5 During splint treatment two spring back joints enable the child to make light kicking movements and crawl in opposite directions The built in spring automatically returns the foot to the therapeutic position when the child relaxes The BETA Flex Brace foot abductio...

Страница 7: ... foot abduction splint especially for taller children from shoe size 150 mm upon initial fitting It can be extended to a splint width of 37 cm 1 3 2 BETA Flex Mini On request an especially small and light middle section the BETA Flex Mini is available for the BETA Flex Brace foot abduction splint e g for especially small or premature babies As the child grows the middle piece is exchanged for the ...

Страница 8: ...A Flex sole plates The ALFA Flex sole plates are a potential accessory for the foot abduction splints Their use results in a system modifi cation of the orthosis The ALFA Flex sole plates are used in rare cases to attach external custom made foot supports to a foot abduction splint manufactured by Semeda The use of the foot abduction splint with the custom made device does not correspond to the or...

Страница 9: ...peat these steps with the sec ond shoe 5 To attach the splint to the shoes attach the click fastener to the recesses in the sole and slide the splint towards the heel until the fastener clicks into place 6 When both shoes are fastened your child must see the bear dolphin the right way round 2 2 Redness and pressure points Babies skin is not really made for wearing shoes yet i e it is very sensitiv...

Страница 10: ... e flexion of the foot towards the shin is set at 5 10 These settings may seem extreme to people who are not familiar with the Ponseti method but they are normal and necessary for the treatment If you look at your child s last cast you will notice a similar position The length of the splint should be slightly above your child s shoulder width 2 5 2 The BETA Flex Brace foot abduction splint The BET...

Страница 11: ...vocational training in their field of work The orthopaedic technician shoemaker should have carefully read the Semeda usage instructions 2 10 Decommissioning Safe disposal of the product is carried out by the parents or also by the fitting orthopae dic technician The product can be disposed of in household waste according to local regulations 2 11 Reporting serious incidents All serious incidents ...

Страница 12: ...the foot that has been achieved by a plas ter corrective It serves to prevent a relapse renewed deterioration and has no corrective effect Indication For the treatment of idiopathic clubfoot Therapeutic principle Immobilisation of the foot to prevent a recurrence of clubfoot Patient group Babies toddlers children aged 0 5 years Size width Splint length up to 30cm Colour Black blue Material Plastic...

Страница 13: ... Flex Brace foot abduction orthosis is used for babies toddlers and children diagnosed with idiopathic clubfoot according to the conservative therapy approach of Dr Ponseti It serves to maintain the correction of the foot that has been achieved by a plaster corrective It serves to prevent a relapse renewed deterio ration and has no corrective effect The rotors enable the child to have a limited ki...

Страница 14: ...b duction splint Beta Flex Brace foot abduction splint Specific function As a system orthosis with the foot abduction splint The ALFA Flex foot abduction orthosis is used for babies toddlers and children diagnosed with idiopathic clubfoot according to the conservative therapy approach of Dr Ponseti It serves to maintain the correction of the foot that has been achieved by a plaster corrective It s...

Страница 15: ...orthosis is used for babies toddlers and children diagnosed with idiopathic clubfoot according to the conservative therapy approach of Dr Ponseti It serves to maintain the correction of the foot that has been achieved by a plaster corrective It serves to prevent a relapse renewed deterioration and has no correc tive effect Indication For the treatment of idiopathic clubfoot Therapeutic principle I...

Страница 16: ... instructions ITEM NUMBER Indicates the manufacturer s item number so that the medical device can be identified LOT NUMBER Displays the manufacturer s lot number so that an individual medical de vice can be identified DATE OF MANUFACTURE Displays the date the medical device was manufactured MEDICAL DEVICE Symbol indicating that the product is a medical device MANUFACTURER Indicates the manufacture...

Страница 17: ... Tight en screws with 3 or more turns and secure with LOCTITE 222 Putting on Shoes and Brace 1 Place the foot into the shoe the heel must be placed at the backmost bottom part of the shoe check in the heel window 2 First close the middle strap tightly keeps the heel in the right position Close the other straps looser 3 Place the shoe on the click system from above and pull the brace back in direct...

Страница 18: ...rx key and remove the cover plate 3 Insert the rail arms into the base body blue as shown in picture 1 4 Put on the cover plate and tighten the screws 5 Adjust the rail length to at least the shoulder width of the child 6 Tighten the screws in 3 or more passes secure with LOCTITE 222 1 2 3 Semeda GmbH Am Petersberg 36 D 29389 Bad Bodenteich Tel 49 0 5824 98 555 0 email info semeda de Foot abductio...

Страница 19: ...h Re tighten the screws firmly Adjustment of angles Unscrew the screws one quarter turn on the upper side of the brace using the Allen key Turn the plate gradually outwards and let it lock into place at the desired angle degree see window under the shoe support plate Ponseti recommends 70 for clubfoot 40 for a healthy foot Re tighten the screw firmly Putting on Shoes and Brace 1 Insert the foot in...

Страница 20: ...the left 3 Remove the rotor casing from the brace base 4 Remove the metal pin from its position between the arms of the spring Then remove the spring This loosens the inner part of the rotor 5 Insert the inner part of the rotor into the rotor case again and keep it fixed in its position 6 Insert the new spring so the lower spring arm is over metal pin 2 and the upper spring arm is under metal pin ...

Страница 21: ...tations Torx key T 10 2 Then open the rotor casing from the bottom a gap wide 3 Pull the bar out of the rotor casing 4 In its place insert the BETA Flex Mini 5 Press the two halves of the rotor casing together again firmly and tighten the screws again 6 Repeat the process with the other rotor casing 1 2 3 4 Semeda GmbH Am Petersberg 36 D 29389 Bad Bodenteich www semeda de Inserting the BETA Flex M...

Страница 22: ...nfirmed by the CE mark The current version of the EU declaration of conformity can be requested from Semeda at any time For orthopaedic tech nicians the declaration of conformity is available for download at www semeda de under the section english download technicians 5 Assembly instructions ...

Страница 23: ... Wearing Diary app everything under control digitally A consistent daily implementation of splint treat ment is an important building block for a lasting therapeutic success With the Semeda Wearing Diary app I can easily and conveniently record my wearing times digitally and thus optimally im plement my therapy scheme Many other practi cal functions make the app a smart companion during splint tre...

Страница 24: ...SEMEDA GmbH Am Petersberg 36 D 29389 Bad Bodenteich Deutschland Germany Tel 49 0 5824 98 555 0 Fax 49 0 5824 98 555 20 Mail info semeda de Web www semeda de ...

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