InStep AF-100 User manual

IN STEPCARBON AFO
P/N: AF-100
INFORMATION
• Please read this document carefully.
• Follow the safety instructions.
Explanation of Symbols
! CAUTION Warnings regarding possible risks of accident or injury.
NOTICE Warnings regarding possible technical damage.
INFORMATION Additional information on the fitting / use.
1 Description
1.1 Intended Use
The In Step AFO is to be used exclusively for orthotic fittings of the lower limbs and a sock should
be used when there is contact with healthy and intact skin.
1.2 Indications and Effects
In Step AFO supports with drop foot conditions with no more than mild spasticity, e.g. after
stroke, traumatic brain injury, multiple sclerosis, neural muscle atrophy, peroneal palsy etc.
In Step AFO fits patients with:
• a stable ankle
• no or only mild impairment of motor knee control
• active patients, walking indoors as well as outdoors
For foot deformities: In Step AFO is indicated when a passive foot deformity can be corrected
through the use of an additional insole in combination with a sturdy shoe.
The In Step AFO is generally suitable for sports activities, as long as no fast, sudden movements
are executed in extreme stride sequences (e.g. basketball, badminton or bicycle riding with high
activity).
In any case, activities should be discussed with the patient and a special fitting for high activity
levels realized where applicable. Not recommended for squatting or kneeling while wearing In Step
AFO.
Effects:
In Step AFO provides the user with a more natural gait pattern; a faster and more stable walk. The
toes and foot are lifted up during swing phase (clearance) and “foot slap” is prevented. Energy
restoring gives a propel effect at initial swing phase.

! CAUTION
In Step AFO is a dynamic ankle foot orthosis and not be used for prevention of contractures, etc.
1.4 Safety Instructions
INFORMATION
The patient is to be instructed in the proper use/care of the product.
The initial fitting and application of the product must only be carried out by trained, qualified
personnel. The daily duration of use and period of application are dependent on medical indication
by the physician.
! CAUTION
Risk of injury as a result of improper use. The product is designed for use on one patient
only. Parts to be fitted and those parts that come directly into contact with the skin can cause
functional and hygienic risks if the orthosis is used by another person.
An orthosis/support applied too tightly to the body can cause local pressure and, in some cases,
even restrict adjacent vessels or nerves. Do not apply the product too tightly. Consult a physician
immediately if you experience unusual changes (such as increase in pain).
Improper changes to the product are not permitted.
! CAUTION
Risk of accident when driving a motor vehicle. The ability to drive a vehicle when wearing
an In Step AFO is determined from case-to-case basis by provider. Criteria include the type of fitting
(clinical picture, fitting) and the individual abilities of the In Step AFO user.
All users are required to observe the applicable national driving laws when operating motor vehicles.
For insurance purposes, drivers should have their driving ability examined and approved
by an authorized test center.
! CAUTION
Risk of injury due to incorrect environmental conditions. The user must be informed of the
risks that exceptional situations might present. For example, jumping down from great height
(more than 1 meter / 39 inches) may expose the spring to severe overload and cause it to break.
NOTICE
Damage due to incorrect environmental conditions. This product is not flame-resistant. Keep
the product away from flames or other heat sources.
The product should not come into contact with grease or acidic agents, unguents and lotions.
This may reduce the products period of use.
1.5 Construction
Thanks to its construction with three dynamic elements (the pylon, the heel and forefoot of the
sole) the orthosis provides a smooth natural gait on even and uneven grounds.
NOTICE
Damage due to inadmissible handling. The orthosis is made of pre-impregnated carbon fiber
material and cannot be thermoformed. The foot of the sole and the connection elements must
be free from holes as these would interrupt the fibers and weaken the component.

2 Handling
2.1 Size Selection of the product
The size selection of the orthosis is based on the shoe size. Left and Right. Small, Medium, and Large.
2.2 Adapting and Applying the product
1. Shoe selection: to obtain best effect of the In Step AFO, the user needs to wear a stable, laced shoe
with a firm heel counter. The heel height should be 1,0 cm (+/-5 mm) / 0,4 inches (+/-0,2 inches).
2. Pick out correct size from the size chart.
3. Adapt the In Step AFO into correct size: If the user has a removable inner sole in his/her shoe, use
that for marking the correct size on the footplate. (pic. 1), or draw a line around the user’s foot
directly on the foot plate.
4. Grind the foot plate by use of a grinding machine into correct size (according to the line on
the foot plate), and avoid grinding into the carbon. When adjusting the foot plate width; grind on the lateral
side but not more than necessary, to avoid the medial part/the insert to slide in the shoe and to avoid
pressure on the medial malleoli (pic. 2). When adjusting the length of the foot plate, focus on grinding the
back of the foot plate, then the insert will automatically be positioned behind (posterior) the medial
malleoli which prevents pressure on the ankle and malleoli (pic. 3).
5. The shell can be adjusted by grinding, if necessary. Never modify the upright or around footplate
attachment.
6. In the event of sharp edges at the orthosis, smooth them out by grinding the edges in water
with wet/dry sand paper.
7. If the user has a foot deformity, correct it with a corrective insole or a custom molded device.
(If the foot cannot be corrected by an insole, the orthosis and a stable shoe, a IN STEP AFO should
not be used).
8. Apply the textile part on the calf part of the orthosis (pic. 4).
9. Cut the soft Velcro part at a proper length. To assure a good attachment, the soft Velcro should not be
more than 2 cm longer than the hard Velcro, when the calf band is attached around the user’s calf.
2.3 Instruction for use and care
Material: Carbon fiber composite. Calf band: Neoprene material, micro hook and loop, soft Velcro tape.
Cleaning:
• Textile part: Machine wash at 40 °C (104 °F) is recommended when necessary but approximately
twice a week. Use a standard mild detergent. Wash out thoroughly and air-dry. Note: Residues
of cleaning agents may cause skin irritations and wear of material.
• Composite part: wipe off with a moistened rag when necessarily.
Your Orthotist can supply you with extra calf cover (AF-ST-L (left) or AF-ST-R (right)) when needed.
Upper limit temperature: 120 °C.
Disposal after use: Do not burn, Combustible material.
3 Further Usage Restriction Clause
The product has been designed for use on only one patient. The daily duration of use and period
of application are dependent on the medical indication.
Latex Safe: To our knowledge this product does not contain any natural rubber.
4 Liability
The ST&G warranty applies only if the product has been used under the conditions and for the
purposes described. The manufacturer recommends that the product be used and maintained in
accordance with the instructions for use.
5 CE Conformity
This product meets the requirements of the 93 / 42 / EWG guidelines for medical products. This
product has been classified as a class I product according to the classification criteria outlined in
appendix IX of the guidelines. The declaration of conformity was therefore created by ST&G
with sole responsibility according to appendix VII of the guidelines.
AF-100 IFU Rev. A (10-09-20)