semeda ALFA-Flex Parts list manual

Semeda GmbH
Am Petersberg 36
29389 Bad Bodenteich
TL 3001-002
ALFA-Flex & BETA-Flex
Foot Abduction Orthosis
Usage Instructions
EN

2
Contents
1. Information about our products.......................................................................................... 3
1.1 Warning and safety instructions.............................................................................................. 3
1.2 ALFA-Flex & BETA-Flex foot abduction orthosis .................................................................... 5
1.2.1 Specic function ............................................................................................................. 5
1.2.2 How it works................................................................................................................... 5
1.2.3 Foot support ................................................................................................................... 5
1.2.4 The AFLA-Flex Brace foot abduction splint /
ALFA-Flex XL Brace foot abduction splint...................................................................... 5
1.2.5 Die BETA-Flex Brace foot abduction splint .................................................................... 6
1.3 Accessories ............................................................................................................................ 7
1.3.1 ALFA-Flex XL central oval, extension kit........................................................................ 7
1.3.2 BETA-Flex Mini .............................................................................................................. 7
1.3.3 ALFA-Soft heel pad........................................................................................................ 7
1.3.4 Protective pad for the foot abduction splints .................................................................. 8
1.3.5 ALFA-Flex sole plates .................................................................................................... 8
2. Application ............................................................................................................................ 9
2.1 Putting on the orthoses........................................................................................................... 9
2.2 Redness and pressure points................................................................................................. 9
2.3 Foot sweat and moisture ...................................................................................................... 10
2.4 Clothing ................................................................................................................................ 10
2.5 Adjusting the splints.............................................................................................................. 10
2.5.1 The AFLA-Flex Brace foot abduction splint /
ALFA-Flex XL Brace foot abduction splint.................................................................... 10
2.5.2 The BETA-Flex Brace foot abduction splint ................................................................. 10
2.6 Cleaning the ALFA-Flex or BETA-Flex foot abduction orthosis ............................................ 10
2.7 Known contraindications and side e󰀨ects when using
the ALFA-Flex or BETA-Flex foot abduction orthosis............................................................ 10
2.8 Fitting the ALFA-Flex or BETA-Flex foot abduction orthosis..................................................11
2.9 Training or specic qualications 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 specications of the ALFA-Flex foot abduction orthosis ....................................... 12
4.1.1 Specic properties of the ALFA-Flex Brace foot abduction splint /
ALFA-Flex XL Brace foot abduction splint.................................................................... 12
4.1.2 Specic properties of the foot supports........................................................................ 13
4.2 Technical specications of the BETA-Flex foot abduction orthosis....................................... 13
4.2.1 Specic properties of the BETA-Flex Brace foot abduction splint ................................ 13
4.2.2 Specic characteristics of the foot supports................................................................. 14
4.3 Technical specications of the foot supports ........................................................................ 14
4.3.1 Specic characteristics of ALFA-Flex foot supports ..................................................... 14
4.3.2 Specic characteristics of COMFOOT bandage shoes / foot supports........................ 15
4.4 Denition of symbols and identifying colours........................................................................ 16
5. Assembly instructions (for orthopaedic technicians only) ............................................ 17
5.1 Assembly instructions for the ALFA-Flex Brace foot abduction orthosis...................... 17
5.2 Assembly instructions for the ALFA-Flex Brace XL foot abduction orthosis ......................... 18
5.3 Assembly instructions for BETA-Flex foot abduction orthosis .............................................. 19
5.4 Assembly instructions for BETA-Flex Mini, short splint bar .................................................. 21
6. More Solutions from the World of Semeda...................................................................... 23

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IMPORTANT
PLEASE READ CAREFULLY BEFORE USE
STORE FOR LATER REFERENCE
Read these usage instructions carefully. Observe all instructions. Keep these usage instructions in a safe place for future
reference. If other people use this product, please make these usage instructions available to them.
1. Information about our products
1.1 Warning and safety instructions
Check the correct connection of the foot abduction splint with the foot supports each time
you put on your orthosis.
Make sure that your foot is correctly and rmly 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 foot abduction orthosis (one pair of foot supports and one foot abduction splint
each) may only be tted by professionally trained personnel (orthopaedic shoemaker or
orthopaedic technician).
1. Information about our products

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If a defect occurs in the ALFA-Flex or BETA-Flex foot abduction orthosis, please contact
your orthopaedic technician or orthopaedic shoemaker.
Foot abduction splints should not be hit on hard objects (e.g. by the child bouncing on the
oor). The splint could break!
When the orthosis is not being worn, it must be kept out of the reach of children.
The foot abduction orthosis may only be worn with socks!
The foot supports are not running shoes and should only be worn in combination with the
splint!
Please do not use any harsh cleaning agents, as these can attack the plastic and the
leather.
Safe tting of the ALFA-Flex Brace and BETA-Flex Brace foot abduction splint can and
must only be carried out by the tting 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 to a relapse! If you have any questions or
problems regarding the settings, please contact your orthopaedic shoemaker, orthopaedic
technician or prescribing paediatric orthopaedist to t them for you. Semeda accepts no
liability for unauthorised and improper tting!
1. Information about our products

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1.2 The ALFA-Flex and BETA-Flex foot abduction orthosis
1.2.1 Specic function
The ALFA-Flex and BETA-Flex foot abduction orthosis is used for babies/toddlers and children diagnosed with idiopath-
ic 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 corrective e󰀨ect.
The orthopaedist prescribes an orthosis to continue their treatment. The orthopaedic technician (or orthopaedic shoe-
maker) ts the orthosis to the children on the basis of the orthopaedist’s prescription. The parents of a󰀨ected children
put the orthosis on daily. The orthosis is a reusable product.
1.2.2 How it works
The foot abduction orthosis consists of a foot abduction splint (ALFA-Flex Brace/ ALFA-Flex Brace XL or BETA-Flex
Brace) and a foot support (ALFA-Flex shoes / foot supports or COMFOOT bandage shoes / foot supports).
There are three di󰀨erent models of foot supports, each of which ts the ALFA-Flex Brace foot abduction splint / AL-
FA-Flex XL Brace foot abduction splint and BETA-Flex Brace foot abduction splint:
1. ALFA-Flex shoes / Henry foot supports
2. COMFOOT-Blue bandage shoes / foot supports
3. COMFOOT-White bandage shoes / foot supports
Foot abduction orthosis
Foot abduction 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
here. The ALFA-Flex XL Brace foot abduction splint is listed as a variant of the ALFA-Flex Brace foot abduction splint. It
is created in a conguration with the accessory part of the ALFA-Flex XL central oval, extension kit. The ALFA-Flex XL
Brace foot abduction splint can also be purchased separately.
The ALFA-Flex Brace foot abduction splint / ALFA-Flex XL Brace foot abduction splint has two ball joints that can be
moved in both directions to set the therapeutic angles dened by the orthopaedist (abduction angle 0°– 80°). Further-
more, the ALFA-Flex Brace foot abduction splint / ALFA-Flex XL Brace foot abduction splint o󰀨ers the possibility to adjust
the dorsal extension (0° – 20°).
The ALFA-Flex Brace foot abduction splint has a continuously adjustable splint length up to 29 cm in width and
grows with the patient over the entire treatment period. The ALFA-Flex XL Brace foot abduction splint has a maximum
width of 37 cm.
1. ALFA-Flex shoes / Henry foot supports
2. COMFOOT-Blue bandage shoes / foot supports
3. COMFOOT-White bandage shoes / foot supports
1. ALFA-Flex Brace/ ALFA-Flex XL Brace
2. BETA-Flex Brace
1. Information about our products

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c) hemisphere
b) oval center piece
d) ball plate
a) splint arm
The main functional elements of the ALFA-Flex Brace foot abduction splint / the ALFA-Flex XL Brace foot abduction
splint are:
a) 2 splint arms
b) oval centre piece
c) 2 hemispheres
d) 2 ball plates
The ALFA-Flex XL Brace foot abduction splint has a larger central section than the ALFA-Flex Brace foot abduction splint
shown here. This can be seen in the illustrations under the item Accessories.
1.2.5 The BETA-Flex Brace foot abduction splint
The BETA-Flex Brace foot abduction splint immobilises the feet in an abduction angle that can be adjusted between 0°
and 70°; the dorsal extension is xed 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 abduction splint (continuously adjustable splint length up to 29 cm width) grows with the child
throughout the entire therapy period.
The main functional elements of the BETA-Flex Brace foot abduction splint are:
a) Splint arm
b) 2 rotor housings
c) 2x 5° plates
d) 2 springs
c) 5°-plate
b) rotor housing
d) spring, inside
a) splint arm
1. Information about our products

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1.3 Accessories
1.3.1 ALFA-Flex XL central oval, extension kit
The ALFA-Flex XL central oval, extension kit makes it possible to extend the ALFA-Flex Brace foot abduction splint for
particularly tall children so that treatment can be continued for longer. The ALFA-Flex XL central oval, extension kit in-
creases the maximum splint width to 37 cm.
After inserting the ALFA-Flex XL central oval, extension kit, the ALFA-Flex Brace foot abduction splint becomes the ALFA
Flex XL Brace foot abduction splint in conguration.
The ALFA Flex XL Brace foot abduction splint is a foot abduction splint especially for taller children (from shoe size 150
mm upon initial tting). 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 length-adjustable standard module.
1.3.3 ALFA-Soft heel pad
The ALFA-Soft heel pad is particularly suitable for use with the ALFA-Flex shoes / foot supports.
This heel pad gives the foot additional support and prevents or relieves pressure points. It is available in two sizes, can
be glued into the shoe and can be individually cut to size.
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1.3.4 Protective pad for the foot abduction splints
An ALFA-Flex protective pad or a BETA-Flex protective pad is available as an accessory for the particular foot abduction
splint. These can be attached around the respective splint bar or around the central oval. The protective pad serves, for
instance, to prevent injuries to children, but also to protect furniture and oors from scratches.
1.3.5 ALFA-Flex sole plates
The ALFA-Flex sole plates are a potential accessory for the foot abduction splints. Their use results in a system modi-
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 orthotic systems described here. Therefore, we only accept liability for the accesso-
ries provided by us i.e. the sole plate.
ALFA-Flex protective pad BETA-Flex protective pad
1. Information about our products

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2. How to use
2.1 Putting on the orthoses
When you receive the splint from your doctor or orthopaedic technician, they will adjust the angles and the length of the
splint. Please do not change these settings – they are therapeutically necessary!
1. Be sure to put socks or tights on your child. Open all of the shoe’s
fasteners.
2. Place the foot in the shoe so that the heel is all the way back and down.
Check that the shoe is tted correctly using the viewing window.
3. Now close the middle strap rst. It must be done up rmly, as it keeps
the heel in the correct position.
4. Pull the socks on from above and at the toe to straighten the folds. Then
loosely close the remaining straps and repeat 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 sensitive. Although these shoes are made of soft
material, they can sometimes cause pressure marks or blisters.
Red marks or blisters, especially on the back of the heel, usually indicate that the shoe has not been worn rmly enough.
Therefore, it is very important to make sure that the foot is really tight in the shoe, as slipping slightly back and forth in
the shoe can cause pressure marks very quickly. Make sure that the heel rests against the sole at the bottom of the
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shoe by tightening the strap another hole. Never use lotion on red patches of skin. Lotion can make the problem worse.
Reddening of the skin that disappears a short time after the shoe has been removed is not a cause for concern. How-
ever, if the redness becomes more severe and darker, or if a blister forms, please see your doctor as soon as
possible. They will decide how to proceed. If necessary, a plaster cast will be applied again, leaving the a󰀨ected area of
skin exposed so that it can heal. This is because if there are persistent problems when wearing them, it can be an early
sign of a relapse.
2.3 Foot sweat and moisture
For children who are prone to heavy foot perspiration, the unusually long wearing time of 23 hours a day can cause
shoes to be continuously damp. If you use shoes with a leather lining, it can also lead to mould on the inner leather in
rare cases, as this is only tanned with vegetable substances to prevent allergies. We therefore always recommend,
regardless of the lining material:
• air your shoes twice a day for half an hour
• if your feet perspire heavily, change socks several times a day
2.4 Clothing
The foot supports must always be worn with socks or tights. It is important to avoid pressure points. It is advisable to use
socks with few threads and seams on the inside and to make sure that there are no creases in the fabric.
2.5 Adjusting the splints
2.5.1 The AFLA-Flex Brace foot abduction splint / ALFA-Flex XL Brace foot abduction splint
The ALFA-Flex Brace Foot Abduction Splint / ALFA-Flex XL Brace foot abduction splint is usually initially adjusted to
70° external rotation (abduction) for a clubfoot and 40° for an una󰀨ected foot. Dorsal extension – i.e. exion 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 BETA-Flex Brace foot abduction splint allows young patients more freedom of movement with full therapeutic func-
tionality. The abduction angle can be set between 0° and 70°; the dorsal extension is xed at 5° in the therapeutic area.
Two spring-back joints enable a child to more naturally kick and crawl during splint treatment. The reset forces mean that
the feet are always realigned into the desired therapeutic position.
2.6 Cleaning your ALFA-Flex or BETA-Flex foot abduction orthosis
Your foot abduction splints can be cleaned with soap and water without any problems. There is no need to disinfect them.
However, if you use a spray for disinfection or other harsh cleaning agents, the material could be attacked.
2.7 Known contraindications and side e󰀨ects when using the ALFA-Flex or BETA-Flex foot ab-
duction orthosis
An absolute contraindication is an incomplete plaster corrective, especially if the heel is still raised. In this case, the foot
does not sit properly in the shoe and the dorsiexion set on the splint cannot full its purpose (prevention of drop foot
recurrence).
Relative contraindications are multiple impairments in the children to be treated. These are determined in advance by
the respective treating physician of the respective centre of competence for clubfoot treatment according to Ponseti.
Blisters or redness could occur as side e󰀨ects. In this case, parents should contact the responsible orthopaedic tech-
nician.
No other side e󰀨ects are known.
2 How to use

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2.8 Fitting the ALFA-Flex or BETA-Flex foot abduction orthosis
The tting of the respective foot abduction orthosis is to be carried out exclusively by a person specially trained for this
purpose. These are orthopaedic technicians or orthopaedic shoemakers.
2.9 Training or specic qualications of the product user
When the ALFA-Flex or BETA Flex foot abduction orthosis is tted, the orthopaedic technician/shoemaker and the attend-
ing physician instruct the parents and, if applicable, the children being treated in its use.
The qualication of the orthopaedic technician/shoemaker should be a completed vocational training in their eld 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 tting orthopae-
dic technician. The product can be disposed of in household waste according to local
regulations.
2.11 Reporting serious incidents
All serious incidents occurring in connection with the use of the product must be reported
to the manufacturer (see section 3) and to the authority responsible for the monitoring of
medical devices at the user’s place of business.
3. Addresses
3.1 Manufacturer (name, address, contact details)
Semeda GmbH
Am Petersberg 36
29389 Bad Bodenteich
Tel.: [phone]
Fax.: [phone]
Email: [email protected]
Web: www.semeda.de
3. Addresses

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4. Performance data
4.1 Technical specications of the ALFA-Flex foot abduction orthosis
4.1.1 Specic properties of the ALFA-Flex Brace foot abduction splint / ALFA-Flex XL Brace
foot abduction splint
Product name ALFA-Flex Brace foot abduction splint
Item number 0700-000
Medical device item 23.03.02.1001
Used with: Foot supports:
ALFA-Flex shoes / Henry foot supports
COMFOOT-Blue bandage shoes / foot supports
COMFOOT-White bandage shoes / foot supports
Specic function As a system orthosis with the foot supports: The ALFA-Flex foot abduction or-
thosis 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 plas-
ter corrective. It serves to prevent a relapse (renewed deterioration) and has no
corrective e󰀨ect.
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
Features Round oval in the splint bar with bear sticker
Adjustment of abduction angle Range between 0 and 80°
Adjustment of dorsal extension Range between 0 and 20°
Click fasteners for adapting the
foot supports
X
Splint versions
ALFA-Flex XL Brace foot ab-
duction splint
X
Item number AL 0700-0XL
Size/width Up to 37 cm
Accessories for the product
ALFA-Flex protective pad X
Item number AL 0700-001
ALFA-Flex XL central oval, ex-
tension kit
X
Item number AL 0700-1XL
ALFA-Flex sole plates X
Item number ET 0700-003
5. Performance data

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4.1.2 Specic properties of the foot supports
Both the ALFA-Flex shoes / foot supports and the COMFOOT bandage shoes / foot supports can be used as components
of the ALFA-Flex foot abduction orthosis. These foot supports can also be used in the BETA-Flex Brace foot abduction
splint system. In order to avoid listing them twice, the specic characteristics of the foot supports are dealt with under
point 4.3.
4.2 Technical specications of the BETA-Flex foot abduction orthosis
4.2.1 Specic properties of the BETA-Flex Brace foot abduction splint
Product name Beta-Flex Brace foot abduction splint
Item number BE 0600-000
Medical device item 23.03.02.1004
Used with: Foot supports:
ALFA-Flex shoes / Henry foot supports
COMFOOT-Blue bandage shoes / foot supports
COMFOOT-White bandage shoes / foot supports
Specic function As a system orthosis with the foot supports: The BETA-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 e󰀨ect.
The rotors enable the child to have a limited kicking movement.
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 Variable from 200 to 290 mm
Colour Black/blue
Material Plastic
Features Blue rotor housing with dolphin sticker
Adjustment of abduction angle Between 0 und 70°
Adjustment of dorsal extension Fixed at 5°
Click fasteners for adapting the foot sup-
ports
X
Accessories for the product
BETA-Flex protective pad X
Item number BE 0600-001
BETA-Flex Mini, short splint bar X
Item numbers BE 0600-002
ALFA-Flex sole plates X
Item number ET 0700-003
5. Performance data

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4.2.2 Specic characteristics of foot supports
Both the ALFA-Flex shoes/foot supports and the COMFOOT bandage shoes/foot supports can be used as components
of the BETA-Flex foot abduction orthosis. These foot supports can also be used in the ALFA-Flex Brace foot abduction
splint system. In order to avoid listing them twice, the specic characteristics of the foot supports are dealt with under
point 4.3.
4.3 Technical specications of the foot supports
4.3.1 Specic characteristics of ALFA-Flex foot supports
Product name ALFA-Flex shoes / Henry foot supports
Item number AL 1411-size-side
Medical device item The assistive device position of the ALFA-Flex Brace or BETA-Flex
Brace foot abduction splint is used.
Used with: The AFLA-Flex Brace foot abduction splint / ALFA-Flex XL Brace foot ab-
duction splint
Beta-Flex Brace foot abduction splint
Specic 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 serves to prevent a relapse (renewed deteriora-
tion) and has no corrective e󰀨ect.
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 070–210 (foot length in mm)
Colour blue
Material Leather + textile
Features
Click fastener to the splint X
Thorn strap 1
Velcro fasteners 2
Accessories for the product
Heel pad ALFA -Soft 1:
Small, for shoe sizes 70 – 100, item no.:
AL 1700-001
X
Heel pad ALFA-Soft 2:
for shoe sizes from 110, item no.:
AL 1700-002
X
5. Performance data

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4.3.2 Specic characteristics of COMFOOT bandage shoes / foot supports
Product name COMFOOT-White bandage shoes / foot
supports
COMFOOT-Blue bandage shoes / foot
supports
Item number CW 1833-size-side CB 1811-size-side
Medical device item The assistive device position of the ALFA-Flex Brace or BETA-Flex Brace foot abduc-
tion splint is used.
Used with: The AFLA-Flex Brace foot abduction splint / ALFA-Flex XL Brace foot abduction
splint
Beta-Flex Brace foot abduction splint
Specic 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 serves to prevent a relapse (renewed deterioration) and has no correc-
tive e󰀨ect.
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 070–180 (foot length in mm) 070–180 (foot length in mm)
Colour White Blue
Material Leather, neoprene and lycra Leather, neoprene and lycra
Features
Click fastener to the splint X X
Thorn strap 3 1
Velcro fasteners -- 2
Extras for the product -
5. Performance data

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4.4 Denition of symbols and identifying colours
The following symbols are used in the usage instructions and on the product:
CAUTION: This symbol identies warnings and precautions in the usage instructions.
FOLLOW USAGE INSTRUCTIONS: This symbol indicates the need for the user to consult
the usage instructions.
ITEM NUMBER: Indicates the manufacturer’s item number so that the medical device can
be identied.
LOT NUMBER: Displays the manufacturer’s lot number so that an individual medical de-
vice can be identied.
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 manufacturer of the medical device according to the EU
Medical Devices Regulation 2017/745 (MDR).
5. Performance data

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5. Assembly instructions (for orthopaedic technicians only)
5.1 Assembly instructions for the ALFA-Flex Brace foot abduction orthosis
5. Assembly instructions
ALFA-Flex Brace® -ASSEMBLY INSTRUCTIONS -for Orthopaedic Technicians
Foot Abduction Brace for after-care of idiopathic clubfoot as part of the Ponseti Therapy.
Recommended period of treatment: from removal of last plaster cast to child’s 4th/5th year of age.
Contents ALFA-Flex or COMFOOT-Blue Shoes Allen-key 4 mm
Torx-key TX20 ALFA-Flex Foot Abduction Brace
Important information:
Brace: Intended for a max. therapy period of 5 years. Total lifespan: 8 years. Shoes: Lifespan 8 years The year of manufacture can be determined by the first two figures of the batch number. Storage: Protected from frost and direct sunlight, medium humidity
Adjustment of length: Variable length adjustment: 180-300mm
Unscrew 6 screws by using the Torx-key. Adjust bars to child’s shoulder-width as a minimum. 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 direction of the heel until the bolt snaps in Open the brace by pulling the bolt, push brace to block in direction of the toes and lift Shoes not suitable for walking! Danger of slipping!
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1123
Semeda GmbH Am Petersberg 36 D -29389 Bad Bodenteich Tel: [phone] email: [e-mail]
TL 1001-010 (englisch)
Adjustment of angles: 1. Unscrew screws by using the allen-key
2. Choose dorsal extension at scale on ball
(unless given other instructions by doctor: 5-10°)
3. Choose abduction in the window of the bar
(unless given other instructions by doctor: 70° for a clubfoot, 40° for a healthy foot)
4. Strongly tighten screw, to avoid acci-
dental loosening secure with “LOCTITE 222”. (Important: otherwise the child might swallow or choke on the parts)

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5.2 Assembly instructions for the ALFA-Flex Brace XL foot abduction orthosis
5. Assembly instructions
ASSEMBLY INSTRUCTIONS ALFA-Flex Brace XL® for the orthopaedic technician
Mounting ALFA-Flex XL centre oval, extension kit (AL 0700 -1XL): 1. Loosen and remove 6 screws of the original centre oval on the rail (Torx key) and remove the rail arms. 2. Loosen and remove 6 screws of the XL centre oval, extension kit (Torx 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
23
Semeda GmbH Am Petersberg 36 D -29389 Bad Bodenteich Tel: [phone] email:
[e-mail]
Foot abduction orthosis for follow-up treatment of idiopathic clubfoot as part of Ponseti therapy.
Recommended duration of treatment: from the time of the last cast removal until the child is 4/5 years
TL 1001-010 (englisch)

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5.3 Assembly instructions for BETA-Flex foot abduction orthosis
5. Assembly instructions
ASSEMBLY INSTRUCTIONS for the BETA Flex Brace - for Orthopaedic Technicians
Contents 1. ALFA-Flex or COMFOOT Shoes 2. BETA-Flex Foot Abduction Brace 3. Allen-key 5 mm 4. Torx-key T 20 and T 10 5. 2 additional springs with higher resistance 6. 4 Locking pins (of which 2 are replacements) Important information:
Brace: Intended for a max. therapy period of 5 years. Lifespan: 6 years Shoes: Lifespan 8 years The year of manufacture can be determined by the first two figures on the batch number Storage: Protected from frost and direct sunlight, medium humidity
Foot Abduction Brace for after-care of idiopathic clubfoot as part of the Ponseti Therapy.
Recommended period of treatment: from removal of the last plaster cast to the child’s 4
th
/ 5
th
year of age.
2
4
6
Adjusting the length: Variable length adjustment from 200 to 290 mm. Unscrew 2 screws (Torx-key T 20). Adjust the brace length to at least (!) the child’s shoulder- width. 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 into the shoe so that the heel is firmly at the back and on the sole - check in the heel window. 2. First close the middle strap tightly (keeps the heel in the correct position). Close the other straps more loosely. 3. Place the shoe on the click system from above and slide the brace backwards in the direction of the heel until the bolt snaps into place. Open the brace by pulling the bolt, push the brace as far as it will go in the direction of the toes and lift off. Shoes not suitable for walking! Danger of slipping!
1
3
5
TL 1101-007 (englisch)
For infants with a shoulder-width of less than
20 cm, we offer the extra-light BETA-Flex mini.
The 8.5 cm long base can be connected to the
rotors of the BETA-Flex Brace.
Semeda GmbH Am Petersberg 36 D - 29389 Bad Bodenteich Tel: [phone] email:
[e-mail]

20
5. Assembly instructions
Locking the BETA Flex Brace
Fußabduktionsorthese
Inserting the stronger springs
1. Loosen both screws that hold the
two halves of the rotor casing together (Torx-key T 10).
2. Turn the brace and pull off the
casing half on the reverse side.
3. Insert the locking pin as far as it
will go into the hole in the inner part of the rotor.
4. Close the rotor casing again. In
doing so, the locking pin catches in the hole provided on the inner side of the rotor casing.
5. Reconnect the two halves of the
rotor casing with the two screws.
6. Repeat the process with the other rotor casing.
1. Lubricate the new springs with spindle grease on the inside and outside. 2. Open the rotor casing according to points 1 and 2 in the instructions on 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 2.
7. Turn the spring into the correct position while keeping the tension and push it
onto the plastic dome of the rotor casing.
8. Insert metal pin 1 into the hole provided in the rotor casing between the
spring arms.
9. Replace the brace base in the rotor casing. 10. Close the rotor casing according to points 4 and 5 in
the instructions on the left.
11. Repeat the process with the other rotor casing.
1
2
3b
4
3a
5
3
4a
4b se pa rat en wi ed er wi e
5
6
7
8
9
Inner Part of
the Rotor
Metal Pin 2
Rotor Casing
Spring
Metal Pin 1
Upper
Arm
Lower
Arm
Dome