MD Orthopaedics Mitchell Ponseti Ankle Foot Orthosis User manual

Instructions for Use
Mitchell Ponseti® Ankle Foot Orthosis (AFO) and
Ponseti®Abduction Bar
MD Orthopaedics, Inc.
604 North Parkway Street
Wayland, IA 52654 USA
www.mdorthopaedics.com
Document MD-124
Version 8.0
January 2022
Emergo Europe B.V.
Prinsessegracht 20, 2514 AP
The Hague, The Netherlands
MedEnvoy
Prinses Margrietplantsoen 33
Suite 123
2595 AM The Hague
The Netherlands EN

Table of Contents
DISCLAIMER.......................................................................................................................................................................................................................................1
TRADEMARKS ...................................................................................................................................................................................................................................1
1 PREFACE ......................................................................................................................................................................................................................................1
1.1 Intended Purpose........................................................................................................................................................................................................1
1.2 Target Patient Group and Intended Users.......................................................................................................................................................2
1.3 Clinical Benets ............................................................................................................................................................................................................2
1.4 Explanation of Safety Warnings ...........................................................................................................................................................................2
1.5 Retention Instructions...............................................................................................................................................................................................2
1.6 Obtaining Documentation and Information..................................................................................................................................................2
1.6.1 Ordering Documentation...........................................................................................................................................................................2
1.6.2 Other languages.............................................................................................................................................................................................2
1.6.3 Documentation Feedback..........................................................................................................................................................................2
1.6.4 Support and service......................................................................................................................................................................................2
1.6.5 Name and address of the manufacturer ............................................................................................................................................3
2 DESCRIPTION OF THE PRODUCT .....................................................................................................................................................................................3
2.1 Intended Use and Reasonably Foreseeable Misuse....................................................................................................................................3
2.2 Sterilization State and Method.............................................................................................................................................................................3
2.3 Summary of Safety and Clinical Performance...............................................................................................................................................3
2.4 Technical Characteristics..........................................................................................................................................................................................4
2.4.1 Mitchell Ponseti® Ankle Foot Orthotic.................................................................................................................................................5
2.4.2 Ponseti® Abduction Bar...............................................................................................................................................................................5
3 SAFETY INSTRUCTIONS .......................................................................................................................................................................................................5
3.1 How to Use the Product Safely..............................................................................................................................................................................6
3.1.1 Technical life span and Warranty............................................................................................................................................................6
3.1.2 Safety information related to the intended use and reasonably foreseeable misuse.................................................6
3.1.3 Product limitations and restrictions and contraindications.....................................................................................................6
3.1.4 Safety information when using the device in combination with other devices..............................................................6
3.1.5 Safety information regarding the use .................................................................................................................................................6
3.1.6 Safe Disposal....................................................................................................................................................................................................6
3.2 Potential Health Consequences............................................................................................................................................................................6
4 INSTRUCTIONS FOR USE.....................................................................................................................................................................................................7
4.1 Clubfoot Treatment Overview...............................................................................................................................................................................7
4.2 Mitchell Ponseti® AFO................................................................................................................................................................................................8
4.3 Ponseti® Abduction Bar ............................................................................................................................................................................................9
5 PREPARATION..........................................................................................................................................................................................................................9
5.1 How to Transport and Store the Product..........................................................................................................................................................9
6 MAINTENANCE.........................................................................................................................................................................................................................9
6.1 Reusing the Device .....................................................................................................................................................................................................9
6.1.1 Cleaning the device.......................................................................................................................................................................................9
6.2 How to Inspect the Product ....................................................................................................................................................................................9
7 TROUBLESHOOTING .......................................................................................................................................................................................................... 10
7.1 How to Identify and Solve Problems............................................................................................................................................................... 10
7.1.1 Troubleshooting by non-skilled persons......................................................................................................................................... 10
7.2 Frequently Asked Questions............................................................................................................................................................................... 10
8 GLOSSARY ............................................................................................................................................................................................................................... 11
9 ICON LEGEND......................................................................................................................................................................................................................... 12

1Document MD-124
DISCLAIMER
MD Orthopaedics makes no representations or warranties with respect to this manual and, to the maximum extent permitted by law,
expressly limits its liability for breach of any warranty that may be implied to the replacement of this manual with another. Furthermore,
MD Orthopaedics reserves the right to revise this publication at any time without incurring an obligation to notify any person of the
revision.
As the designer and manufacturer of products, MD Orthopaedics does not provide medical treatment and/or advice. Information
about the risks and benets of medical treatment, including treatment that involves the use of MD Orthopaedics products and
available alternatives is provided solely by physicians or other health care providers. If you have questions about your child’s treatment,
itisimportant to discuss those questions with the appropriate health care provider.
MD Orthopaedics does not, and cannot, warrant certain results from the use of its products.
The information provided in this documentation contains general descriptions and/or technical characteristics of the performance of
the products contained herein. This documentation is not intended as a substitute for and is not to be used for determining suitability
or reliability of these products for specic user applications. It is the duty of any such user to perform the appropriate and complete risk
analysis, evaluation, and testing of the products with respect to the relevant specic application or use thereof. Neither MD Orthopaedics
nor any of its aliates or subsidiaries shall be responsible or liable for misuse of the information that is contained herein. If you have any
suggestions for improvements or amendments or have found errors in this publication, please notify us.
All pertinent state, regional, and local safety regulations must be observed when using this product. For reasons of safety and to help
ensure compliance with documented system data, only the manufacturer shall perform repairs to components.
When devices are used for applications with technical safety requirements, the relevant instructions must be followed. Failure to observe
this information can result in injury or equipment damage.
MD Orthopaedics has made every eort to prevent that the labelling, instructions for use, making available, putting into service and
advertising of devices uses text, names, trademarks, pictures and gurative or other signs that may mislead the user or the patient
regarding the device’s intended purpose, safety, and performance.
Copyright © 2022 by MD Orthopaedics, Inc.
All rights reserved. No part of this publication may be reproduced, distributed, or transmitted in any form or by any means, including
photocopying, recording, or other electronic or mechanical methods, without the prior written permission of the publisher. For permission
requests, write to the publisher at the address below.
MD Orthopaedics, Inc.
604 North Parkway Street
Wayland, IA 52654
USA
[phone]
www.mdorthopaedics.com
TRADEMARKS
Mitchell Ponseti® and Ponseti® are registered trademarks of MD Orthopaedics.
MD Orthopaedics has made every eort to supply trademark information about company names, products and services mentioned in
this manual. Trademarks shown below were derived from various sources. All trademarks are the property of their respective owners.
General Notice: Some product names used in this manual are used for identication purposes only and may be trademarks of their
respective companies.
1 PREFACE
1.1 Intended Purpose
The Mitchell Ponseti® Ankle Foot Orthosis (AFO) and Ponseti® Abduction Bar is an ankle-foot orthosis, also known as
Mitchell Ponseti® Brace, intended for use in the Ponseti Method of treatment for the correction of CongenitalTalipes Equinovarus (CTEV)
in infants and children less than or equal to eight years of age. The brace is intended to prevent relapse (equinus and varus deformity of
the heel).
The Mitchell Ponseti® Brace is to be prescribed by a physician or health care provider trained in the Ponseti Method of clubfoot treatment
and is typically worn for 23 hours a day for three months after casting and then during night-time and nap time for 4-5 years or until the
physician or health care provider indicate the device is no longer needed.
A clinical orthotist, also trained in the Ponseti Method, may assist the physician or health care provider in determining the correct size
of the AFO for the child. The orthotist may also train the child’s parents and families in the right way to put the AFO onto the child’s foot,
what cues may indicate poor t or other issues, and how to determine it is time to move to the next size.
Other members of the clinical team trained in the Ponseti Method – nurses, physician assistants, or other licensed healthcare
professionals– may also train parents on the proper use of the Mitchell Ponseti® Brace and make any necessary adjustments in t or sizing.
The child’s parents or family or other designated caretaker are responsible for adhering to the prescribed Ponseti Method treatment
regimen of 23 hours a day for three months, then during sleep and during naptime for the next 4-5 years or until the physician indicates
the device is no longer needed.

2Document MD-124
1.2 Target Patient Group and Intended Users
The MD Orthopaedics Mitchell Ponseti® Ankle Foot Orthosis (AFO) and Ponseti® Abduction Bar is designed to be worn by a child
(≤8)years of age with clubfoot after the casting portion of treatment is complete.
This document is intended for the physician, orthotist, clinical team, parents, and families of children receiving treatment with the
Mitchell Ponseti® Ankle Foot Orthosis (AFO) and Ponseti® Abduction Bar.
1.3 Clinical Benets
The Ponseti Method is a non-surgical clubfoot treatment process developed by Dr. Ignacio Ponseti. The method utilizes gentle
manipulation and casting to gradually move the foot into the correct position. Each week the cast is removed, the foot carefully
manipulated into the next position, and a new cast is applied. This process continues for up to 6 to 8 weeks.
Following the casting period, the feet are held in the proper position using a foot abduction brace (FAB). The brace is comprised of the
Ankle Foot Orthosis (AFO) and the connecting, abduction bar. The brace is typically worn for 23 hours a day for three months, then worn
at night and during naptime for up to 4-5 years or as prescribed by a physician to ensure the correction holds.
With proper treatment and adherence to the bracing protocol prescribed by the physician, it is expected that most cases of clubfoot can
be corrected by the time the child reaches 4 or 5 years of age.
MD Orthopaedics does not provide medical treatment and/or advice. Information about the risks and benets of medical treatment,
including treatment that involves the use of MD Orthopaedics products should be provided solely by the physician or other qualied
health care providers treating your child. If you have questions about your child’s treatment, it is important for you to discuss those
questions with the appropriate health care provider.
1.4 Explanation of Safety Warnings
Caution indicates a hazard with a low level of risk which, if not avoided, could result in minor or moderate injury.
Indicates information considered important, but not hazard-related.
1.5 Retention Instructions
Read and understand this manual and its safety instructions before using this product. Failure to do so can result in injury.
Follow all the instructions.
The product shall only be used by persons who have fully read and understand the contents of this user manual.
Ensure that each person who uses the product has read these warnings and instructions and follows them.
The manufacturer is not liable for cases of material damage or personal injury caused by incorrect handling or non-compliance with the
safety instructions. In such cases, the warranty will be voided.
This policy / warranty is non-transferable and covers normal wear and tear only. Altering the product and after-market modications
will void the warranty. Please contact us if you experience problems not outlined in this policy. Atypical matters will be handled
on acase-by-case basis.
1.6 Obtaining Documentation and Information
1.6.1 Ordering Documentation
Additional documentation, user instructions and technical information can be ordered by calling MD Orthopaedics at [phone]
or e-mailing [e-mail].
1.6.2 Other languages
Instructions for Use (IFU) manuals are available in other languages at www.mdorthopaedicsifu.com.
1.6.3 Documentation Feedback
If you are reading MD Orthopaedics’ product documentation on the internet, any comments can be submitted on the support website.
Comments can also be sent to [e-mail]. We appreciate your comments.
1.6.4 Support and service
For questions, information, technical assistance or to order user instructions, please contact:
MD Orthopaedics, Inc.
604 North Parkway Street
Wayland, IA 52654
USA
www.mdorthopaedics.com
[phone] or e-mail [e-mail]

3Document MD-124
1.6.5 Name and address of the manufacturer
The following natural or legal person makes the device, to which this user manual applies, suitable for use within the European Union and
is the manufacturer of the device:
The Mitchell Ponseti® Ankle Foot Orthosis and Ponseti® Abduction Bar are manufactured by:
MD Orthopaedics, Inc.
604 North Parkway Street
Wayland, IA 52654
USA
www.mdorthopaedics.com
[phone]
2 DESCRIPTION OF THE PRODUCT
2.1 Intended Use and Reasonably Foreseeable Misuse
The Mitchell Ponseti® Brace is a Class I medical device intended for use only on children whose clubfoot is being correctedwith the
Ponseti Method of treatment, and only as prescribed by a physician fully trained in the Ponseti Method.
The Mitchell Ponseti® Brace shall not be used without prescription by a physician trained in the Ponseti method and is to be used only
as prescribed.
The Mitchell Ponseti® Brace shall not be used to treat any other orthopedic condition other than clubfoot unless otherwise prescribed
by the physician or orthotist.
The Mitchell Ponseti® Ankle Foot Orthosis shall be used with the following original accessories and components only:
• Ponseti® Adjustable Bar
oAvailable with either 10 or 15 degrees of dorsiexion.
• Pressure Saddle: This soft, comfortable pressure saddle attaches to the middle strap of the Mitchell Ponseti® AFO to provide addi-
tional relief of pressure areas. Available in size small and large. Size small is recommended for use with AFO Size 0000-1; Size large is
recommended for use with Size 2-12.
• Bar Cover: This soft bar cover provides protection and comfort for your child, and is available in size small (5") and large (8"), in pink,
light blue, or dark blue.
The Mitchell Ponseti® Ankle Foot Orthosis is available in four styles:
The Mitchell Ponseti® Standard AFO uses the Ponseti Method of clubfoot correction. Our patented system features a soft lining for
comfort and compliance, soft synthetic leather straps. The location of the heel can easily be seen through two viewing holes in the back
of the AFO. The AFO is worn attached to the Ponseti® Abduction Bar in accordance with the standard Ponseti bracing protocol. Available
in sizes preemie through 12.
The Mitchell Ponseti® Plantar Flexion Stop AFO: The articulated Plantar Flexion Stop limits plantar exion with rigid dorsiexion to
maintain the prescribed position of the foot. Recommended for the complex clubfoot. This device is also good for children with
hyper exible feet as it ensures the foot is always held in a neutral or dorsiexed position. The AFO is worn attached to the
Ponseti®Abduction Bar in accordance with the standard Ponseti bracing protocol. Available in sizes 00 through 12.
The Mitchell Ponseti® Toe Stilt AFO was specically designed by recommendation of Dr. Ponseti to maintain clinically desirable
dorsiexion by stretching the Achilles tendon and helping to keep the foot exible. This is achieved by the placement of a built in wedge
attached to the front of the AFO which keeps both feet in a dorsiexed position of 10 degrees when standing.The AFO is worn attached to
the Ponseti® Abduction Bar in accordance with the standard Ponseti bracing protocol. The patient must be able to stand independently
for the Toe Stilt AFO to have any eect when used without the Ponseti® Abduction Bar. Available in sizes 2 through 11.
The Mitchell Ponseti® Plantar Flexion Stop/Toe Stilt is a dual purpose AFO that supports the Ponseti Method of treating clubfoot. The AFO
is worn attached to the Ponseti® Abduction Bar in accordance with the standard Ponseti bracing protocol. The Plantar Flexion Stop (PFS)
is designed to structurally limit any plantar exion and work particularly well in clubfoot cases with hypermobile or corrected atypical/
complex deformity. The PFS is mounted on the standard AFO during the assembly process but is designed to be custom t as necessary
by the orthotist to meet the dynamic needs of each clubfoot child. The Toe Stilt encourages lower calf, Achilles tendon and plantar fascia
stretch in the toddler who can stand independently without the Ponseti® Abduction Bar. The Toe Stilt holds both feet at 10 degrees
dorsiexion when standing. Available in sizes 2 through 11.
Education on proper brace application and troubleshooting for skin issues is critical to ensure your child’s clubfoot correction is
eective. DO NOT USE this device without rst being trained by your physician or clinical team. Contact Customer Support for
assistance in locating training resources.
2.2 Sterilization State and Method
Not applicable, as the Mitchell Ponseti® Brace is not a sterile product.
2.3 Summary of Safety and Clinical Performance
The Mitchell Ponseti® Brace is a Class I, non-implantable device. Therefore, a Summary of Safety and Clinical Performance is not required.

4Document MD-124
2.4 Technical Characteristics
The Mitchell Ponseti® AFO was designed with a soft, contoured elastomeric liner to cushion and hold the child’s foot in place. Straps
and abody made from a ductile synthetic suede conform to the shape of the foot for added comfort and stability.The AFO has openings
onthe side to add ventilation and keep the foot cool, and viewing holes to help gauge proper placement of the heel intheAFO.
NOTE: Socks are required to eliminate skin contact with product.
The Ponseti® Abduction Bar was designed to be easily adjustable to the shoulder width of the child. The Quick Clips make it easy for the
bar to be attached and removed from the AFOs as needed.
The length of the foot should be measured from the heel to tip of big toe. Do not add growing room as this is allowed for in the
tablebelow.
The Preemie AFOs are permanently attached to an adjustable bar.
MD Orthopaedics’AFO Sizing Chart Legacy European AFO Sizing Chart
Length and width
measurement
locations
A
B
Mitchell
Ponseti®
AFO Size
(A) Foot
Length(cm)
(B) Foot
Width(cm)
Mitchell Ponseti®
AFOSize
(A) Foot
Length
(mm)
P6-0 * 5.5 to 6.5 2.5 to 4.0 P6-0 (Preemie 1) 60 to 62
P5-0 * 5.8 to 6.9 3.0 to 4.5 P5-0 (Preemie 2) 63 to 66
0000 6.0 to 7.3 3.3 to 4.8 0000 67 to 70
000 6.3 to 7.8 3.0 to 5.5 000 71 to 75
00 6.8 to 8.3 3.0 to 5.5 00 76 to 80
0 7.5 to 9.0 3.0 to 6.0 0 81 to 87
1 8.0 to 9.5 3.5 to 6.0 1 88 to 92
2 9.0 to 10.5 3.8 to 6.5 2 93 to 102
3 10.0 to 11.5 4.5 to 7.0 3 103 to 112
4 11.0 to 12.5 4.7 to 7.0 4 113 to 122
5 12.0 to 13.5 4.8 to 7.0 5 123 to 132
6 13.0 to 14.5 5.0 to 7.5 6 133 to 142
7 14.0 to 15.5 5.5 to 8.0 7 143 to 152
8 15.0 to 16.5 6.7 to 8.2 8 153 to 162
9 16.0 to 17.5 7.0 to 8.5 9 163 to 172
10 17.0 to 18.5 7.4 to 8.9 10 173 to 182
11 18.0 to 19.5 7.7 to 9.2 11 183 to 192
12 19.0 to 20.5 8.0 to 9.5 12 193 to 202
Ponseti® Abduction
BarSize **
Minimum Width
(cm)
Maximum Width
(cm)
Extra Short *** 17.3 25.0
Short 20.0 30.0
Long 23.5 37.8

5Document MD-124
When sizing, we recommend leaving 0.5-1.0 cm room for growth; i.e. a foot length of 9.0 cm would be a size 1.
Please email us for sizing assistance at [e-mail].
*The Mitchell Ponseti® Size P6-0 or P5-0 AFOs are permanently attached to a Preemie Bar, which is pre-set to
10°dorsiexion and 60° abduction. The bar adjusts in width from 15.0-20.0 cm, in 1 cm increments. The preemie bar can
becut down as small as 10 cm, upon request.
**The Ponseti® Abduction Bars are available in 10 or 15° dorsiexion.
***The Ponseti® Abduction Bar, size Extra Short Bar can be cut down as small as 11 cm, upon request.
2.4.1 Mitchell Ponseti® Ankle Foot Orthotic
a. Elastomer Lining
b. Tongue
c. Synthetic
Suede Straps
d. Buckles
e. Sole
2.4.2 Ponseti® Abduction Bar
a. Quick Clips
b. Width Adjustment Bar
A hex key (wrench) is also included, for making adjustments of the abduction bar as described in section 4.3.
3 SAFETY INSTRUCTIONS
Use the Mitchell Ponseti® Ankle Foot Orthosis (AFO) and Ponseti® Abduction Bar only in accordance with these instructions and
asdirected by your physician, health care provider or other member of the clinical team.
Improper application of the AFO or bar can lead to skin irritation, sores, and blisters.
Socks are required to eliminate skin contact with product and prevent skin irritation and blisters. Pressure Saddles are recommended.
Consult your physician, health care provider or clinical team immediately if the child is experiencing pain, blisters, sores, or if the AFO is
visibly slipping on the child’s foot.
Do not bend the bar or allow children to walk with the bar attached. Bending of the bar may compromise therapeutic value and lead to
breakage in use, which may cause harm to the patient.
IMPORTANT: Ensure the dressing area is well lit and free from distraction to ensure you apply the AFO properly. Improper application
of the AFO or bar can lead to skin irritation, sores, and blisters.
Read and understand this manual and its safety instructions before using this product. Failure to do so can result in injury.

6Document MD-124
3.1 How to Use the Product Safely
3.1.1 Technical life span and Warranty
• On average, each AFO will last 3-9 months, depending on the child’s growth rate. As the child’s growth rate slows, more time can
be expected.
• The bars are adjustable and may last more than one pair of AFOs if adjustable bar width continues to facilitate shoulder width
requirement. The bar width should be periodically checked and adjusted to match the child’s shoulder width or as recommended
by your physician, orthotist or health care provider.
• Warranty of the Mitchell Ponseti® Brace is one year under normal use, and is single patient multiple use. Normal use is dened by
Normal Daily Use for 365 days/year.
3.1.2 Safety information related to the intended use and reasonably foreseeable misuse
• Use the Mitchell Ponseti® Brace only in accordance with these instructions and as directed by your physician or other member of
the clinical team.
• Consult your physician or clinical team immediately if the child is experiencing pain, blisters, sores, or if they are not in good
condition or do not correctly t the child.
• Do not overtighten the adjusting screws.
• Do not use the Mitchell Ponseti® Brace if it is not in good condition or does not correctly t the child.
• Protect your child, yourself, and your furniture from being hit by the bar when the child is wearing it. It is recommended to pad the
bar with a Ponseti® Bar Cover.
3.1.3 Product limitations and restrictions and contraindications
• Do not bend the bar or allow children to walk with the bar attached. Bending of the bar may compromise therapeutic value and
lead to breakage in use, which may cause harm to the patient.
• Do not use the Mitchell Ponseti® Brace if it is not in good condition or does not correctly t the child.
• The Mitchell Ponseti® Brace shall not be used without prescription by a physician or health care provider trained in the Ponseti
Method and is to be used only as prescribed.
• The Mitchell Ponseti® Brace shall not be used to treat any other orthopedic condition other than clubfoot unless otherwise
prescribed by the physician or health care provider.
3.1.4 Safety information when using the device in combination with other devices
• The Mitchell Ponseti® Ankle Foot Orthosis shall be used with the following original accessories and components only:
oPonseti® Abduction Bar
oPressure Saddle
oPonseti® Bar Cover
Altering the product and/or making after-market modications will void the warranty and may result in injury.
3.1.5 Safety information regarding the use
• Consult your physician or clinical team immediately if the child is experiencing pain, blisters, sores, or if the AFO is visibly slipping
on the child’s foot.
• Do not bend the bar or allow children to walk with the bar attached. Bending of the bar may compromise therapeutic value and
lead to breakage in use, which may cause harm to the patient.
3.1.6 Safe Disposal
• The Mitchell Ponseti® Brace and accessories can be disposed of in the regular trash. None of the components of the device are
recyclable.
3.2 Potential Health Consequences
It is necessary that the brace be worn 23 hours a day for three months and then 12-14 hours a day (naps and nighttime) for 4-5 years or
as directed by your physician or health care provider.
Ensure the area is well lit and free from distraction to ensure you apply the AFO properly. Improper application of the AFO or bar can lead
to skin irritation, sores, and blisters.

7Document MD-124
Incorrect use of the AFO may result in relapse of the clubfoot defect or injury to the child’s foot. If a user and/or patient experiences
anyseriousincident that has occurred in relation to the device, it should be reported to the MD Orthopaedics, Inc. and the competent
authority of the Member State in which the user and/or patient is established.
Please contact MD Orthopaedics if you experience problems not outlined in this policy.
MD Orthopaedics, Inc.
604 North Parkway Street
Wayland, IA 52654
USA
www.mdorthopaedics.com
[phone] or e-mail [e-mail]
4 INSTRUCTIONS FOR USE
4.1 Clubfoot Treatment Overview
Diagnosis
of Clubfoot
(at or before birth)
Treatment Phase
(6 to 8 weeks)
The doctor manipulates
and casts the child’s
foot (feet) using the
Ponseti Method.
1.
2.
3.
4. 5.
6.
7.
8.
Year 4
in AFO
Year 3
in AFO
Year 2
in AFO
Year 1
in AFO
End of your
Clubfoot journey
This info graphic provides that such medical information is merely information - not
advice. If users need medical advice, they should consult a doctor or other
appropriate medical professional. No warranties are given in relationship to the
medical information supplied and no liability will be accrued to MD Orthopaedics in
the event the user suffers loss as a result of reliance upon the information.
Stage
1 - 2 - 3 - 4 - 5
Casting
Tenotomy Procedure
At the final casting,
the doctor releases the
Achilles tendon in
virtually all cases. Maintenance
The child is fitted with
the ankle foot orthosis
(AFO) and bar that are to
be worn 23 hours a day
for 90 days (3 months).
Sleep Maintenance
The AFO and bar are
worn when the child
sleeps for up to 4 - 5
years, as prescribed, to
ensure the correction
holds.
Clubfoot JourneyTM
This infographic provides information — not advice. If you need medical advice, please consult a doctor or other appropriate medical
professional.
No warranties are given in relationship to the medical information supplied and no liability will be accrued to MD Orthopaedics in the event the
user suers loss because of reliance upon the information provided in this infographic.

8Document MD-124
4.2 Mitchell Ponseti® AFO
Carefully inspect the AFO before each use. Never use an AFO or bar that is damaged, broken or not functioning properly, as these
may injure your child and/or render treatment ineective. Always use socks with the AFO to prevent direct contact with the skin.
1. Open the AFO so all the suede straps are clear for inserting the foot. Buckles are designed to
be placed to the inside of the foot. They may be positioned to the outside based on physician
preference or individual convenience of application.
2. Holding the lower leg, gently slide the foot into place until the heel is secure against the back and
bottom of the AFO. Socks that cover the foot and lower leg are required to prevent skin contact
with the AFO.
The exact position of the heel in the AFO will vary depending on the type and severity of the
clubfoot. Forcing the heel into position can lead to sores, so check with your physician to verify
the proper position.
3. Pull tongue horizontally against the ankle and hold in place with your thumb. Be sure the hole in
the tongue is set in the center of the ankle, above the middle strap.
4. Buckle the middle strap securely over the horizontal tongue. Securely buckle the ankle strap but
be careful not to overtighten, as that can lead to skin irritation and sores.
5. Look through the heel viewing holes at the back of the AFO to ensure the heel is ideally down and
to the back of the AFO. The heel may not initially be able to contact the bottom of the AFO after
the tenotomy and last casting but will over time. If you do not see the heel in the viewing holes,
readjust the tongue and middle strap so that the heel is properly positioned.
In some cases, the heel will not touch the bottom of the AFO, and in others the heel will be barely
visible through the heel viewing holes. In these challenging cases, the heel will drop over time as
long as ankle motion is adequate. Forcing the heel into the AFO and overtightening the middle
strap can lead to skin irritation, sores, and reduced bracing compliance.
6. Once upper straps are tight and heel is securely in place, buckle the toe strap and retighten the
other straps if needed.

9Document MD-124
4.3 Ponseti® Abduction Bar
The bar should be set so that the width of the bar is equal to - or even slightly wider than - the shoulder width of the child. Measure the
shoulder width of the child from the outside left shoulder to the right outside shoulder. Adjust the length of the bar, measuring from
the center screw of the left heel cap to the center screw of the right heel cap, so that it is equal to the shoulder width measurement.
Itisimportant to measure the shoulder width regularly and adjustments should be approved by orthotist.
1. Use the enclosed hex key to loosen set screws in bar lock. Adjust the width of the bar to the child’s shoulder width, using the center
screw in the heel caps as a guide. Re-tighten the set screws in the bar lock.
2. Using a screwdriver, loosen center screw of heel cap; remove outer screw. Rotate clip to desired degree indicator to set abduction
(external rotation) as determined by your physician. Re-insert outer screw into appropriate hole. Tighten both screws.
3. Insert clip into sole of AFOs until you hear a“click” - there will be an audible click when they are seated properly. Verify that the bar
lock and Quick Clips are engaged when assembled by pulling on the AFO to make sure it does not disconnect from the bar. If damage
is found discontinue use and contact Customer Service.
5 PREPARATION
5.1 How to Transport and Store the Product
The Mitchell Ponseti® Ankle Foot Orthosis and the Ponseti® Abduction Bar ship at room temperature and require no special handling
during transport or storage.
6 MAINTENANCE
6.1 Reusing the Device
All parts were designed to be used by a single patient under normal use conditions and as prescribed by a physician.
Normal use includes the daily application of the Mitchell Ponseti® Brace and use up to 23 hours per day, or as prescribed.
6.1.1 Cleaning the device
To clean the device:
1. Hand or machine-wash the AFO using cool water, a gentle cycle and mild detergent.
2. Let the AFO air dry completely before use.
3. It is not necessary to wash before using.
Do not use hot water when washing the Mitchell Ponseti® Ankle Foot Orthosis. This may cause the synthetic suede straps to
warp, shrink, separate or delaminate. Do not put the AFO into a mechanical dryer. Air dry only.
6.2 How to Inspect the Product
The Mitchell Ponseti® Ankle Foot Orthosis (AFO) and Ponseti® Abduction Bar should be inspected every time for proper t,
manufacturing defect, and damage prior to the device being placed onto the child’s feet.
Carefully inspect the Mitchell Ponseti® Ankle Foot Orthosis (AFO) and Ponseti® Abduction Bar before each use. Never use an
AFO or bar that is damaged, broken or not functioning properly, as this may injure your child and/or render treatment ineective.
Contact Customer Service for Support, if needed.

10 Document MD-124
7 TROUBLESHOOTING
7.1 How to Identify and Solve Problems
7.1.1 Troubleshooting by non-skilled persons
Error Cause Solution
Child develops blisters or other damage
to the skin Improper t and/or use Contact your physician or healthcare provider
Broken AFO (within 6 months of wear) Manufacturing defect or damaged via
normal use Contact your point of purchase
Broken AFO (after 6 months of wear) Damaged via normal use Contact your point of purchase
Broken Bar, Quick Clip, Heel Cap or
BarLock Damaged via normal use Contact your point of purchase
Incorrect Size (within 7 days of receipt) Sizing Error Contact your point of purchase
7.2 Frequently Asked Questions
Question Answer
Do the buckles go to the
inside of the foot or to the
outside of the foot?
The AFO was designed with the buckles set to the inside of the foot. This design feature is to aid
parents in the donning and dong of the AFOs. Ponseti experts do allow buckles to the outside of
the foot based on professional preference or customer convenience. Itwill not alter the performance
or risk of injury by orienting the buckles outward.
I just received my order, and
the AFOs seem too big/too
small. Is there a dierent size
that would work better?
Contact your point of purchase
The child’s heel is not down in
the AFO. Is something wrong?
If the heel is not visible in the viewing holes, check with your physician to ensure the clubfoot is fully
corrected. If the physician indicates that the correction is good, it may not be necessary to force the
heel down into the AFO, as this can lead to skin irritation, bracing discomfort, and reduced bracing
compliance.
How long will each pair of
AFOs last?
On average, an AFO will last 3-9 months. Some children grow rapidly and will need new AFO’s within
three months. As the child’s growth rate slows, more time can be expected from each AFO.
How long will the bar last?
The bars are adjustable and should last approximately more than one pair of AFOs. The bar width
should be periodically checked and adjusted to match the child’s shoulder width or as recommended
by your physician or orthotist.

11Document MD-124
8 GLOSSARY
Term Meaning
Ankle Foot Orthosis (AFO) An AFO is a brace, usually made of plastic, that is worn on the lower leg and foot to support the ankle,
hold the foot and ankle in the correct position
Casting A procedure to keep the clubfoot in place after manipulation. Padding is wrapped around the foot, then
plaster or berglass is applied, and the cast is molded into place.
Clubfoot (talipes
equinovarus)
Clubfoot (Talipes equinovarus) is a common birth defect in which the foot is twisted out of shape or
position.
In clubfoot, the foot appears twisted and can even look as if it’s upside down. Despite its appearance,
clubfoot itself doesn’t cause any discomfort or pain.
Treatment is usually successful and includes stretching and casting (Ponseti Method) or stretching and
taping (French method). Sometimes, surgery is needed.
Dorsiexion Dorsiexion is the exion of the foot in an upward direction, from the ankle.
Equinus
Equinus is a condition in which the upward bending motion of the ankle joint is limited. Someone with
equinus lacks the exibility to bring the top of the foot toward the front of the leg. Equinus can occur in
one or both feet.
Foot Abduction Brace Abduction is a motion that pulls a structure or part away from the midline of the body. An abduction
brace keeps the foot in proper alignment with the midline.
Orthotist
An orthotist is a healthcare professional who makes and ts braces and splints (orthoses) for people
who need added support for body parts that have been weakened by injury, disease, or disorders of the
nerves, muscles, or bones
Ponseti Method
The Ponseti Method is a non-surgical clubfoot treatment process developed by Dr. Ignacio Ponseti.
Themethod utilizes gentle manipulation and casting to gradually move the foot into the correct
position.
Pressure Saddles A pressure saddle is a piece of soft, exible rubber that attaches to the middle strap of the AFO to
provide additional relief from the pressure of the strap.
Tenotomy
An Achilles tendon release, also known as tenotomy, is a surgical procedure that involves cutting
through the Achilles tendon to allow for nal dorsiexion of the foot. The procedure is used to correct
the equinus deformity seen in clubfoot.

12 Document MD-124
9 ICON LEGEND
Icon Meaning Icon Meaning
Ankle-Foot Orthotic (AFO) Caution
Authorized Representative in the European
Community Date of manufacture
Manufacturer Importer of record
Single Patient, Multiple Use Non-sterile
Indicates Item is a Medical Device Catalog number
CE Mark (in compliance with Regulation (EU)
2017/745 of the European Parliament and of the
council of 5 April 2017 on Medical Devices)
Batch code
Consult Instructions for Use Electronic Instructions for Use

Инструкции за употреба
Ортеза за глезен (ОГ) Mitchell Ponseti® и абдукционен
лост Ponseti®
MD Orthopaedics, Inc.
604 North Parkway Street
Wayland, IA 52654, САЩ
www.mdorthopaedics.com
Документ MD-124
Версия 8.0
януари 2022 г.
Emergo Europe B.V.
Prinsessegracht 20, 2514 AP
The Hague, Нидерландия
MedEnvoy
Prinses Margrietplantsoen 33
Suite 123
2595 AM The Hague
Нидерландия BG

Съдържание
ОТКАЗ ОТ ОТГОВОРНОСТ ...................................................................................................................................................................................................... 15
ТЪРГОВСКИ МАРКИ................................................................................................................................................................................................................... 15
1 ПРЕДГОВОР............................................................................................................................................................................................................................ 15
1.1 Предназначение...................................................................................................................................................................................................... 15
1.2 Целева група пациенти и целеви потребители.................................................................................................................................... 16
1.3 Клинични ползи....................................................................................................................................................................................................... 16
1.4 Обяснение на предупрежденията за безопасност............................................................................................................................. 16
1.5 Инструкции за задържане ................................................................................................................................................................................ 16
1.6 Получаване на документация и информация ...................................................................................................................................... 16
1.6.1 Поръчване на документация............................................................................................................................................................. 16
1.6.2 Други езици.................................................................................................................................................................................................. 16
1.6.3 Обратна връзка за документацията ............................................................................................................................................. 17
1.6.4 Поддръжка и сервиз............................................................................................................................................................................... 17
1.6.5 Име и адрес на производителя ........................................................................................................................................................ 17
2 ОПИСАНИЕ НА ПРОДУКТА............................................................................................................................................................................................. 17
2.1 Предназначение и разумно предвидима неправилна употреба.............................................................................................. 17
2.2 Състояние и начин на стерилизация.......................................................................................................................................................... 18
2.3 Обобщение на безопасността и клиничните показатели.............................................................................................................. 18
2.4 Технически характеристики ............................................................................................................................................................................ 18
2.4.1 Ортеза за глезен Mitchell Ponseti®................................................................................................................................................... 20
2.4.2 Абдукционен лост Ponseti® ................................................................................................................................................................. 20
3 ИНСТРУКЦИИ ЗА БЕЗОПАСНОСТ............................................................................................................................................................................... 20
3.1 Как да използвате продукта безопасно.................................................................................................................................................... 21
3.1.1 Технически срок на експлоатация и гаранция ........................................................................................................................ 21
3.1.2 Информация за безопасност, свързана с предвидената употреба и разумно предвидимата
неправилна употреба............................................................................................................................................................................. 21
3.1.3 Продуктови ограничения, рестрикции и противопоказания ....................................................................................... 21
3.1.4 Информация за безопасност при използване на изделието в комбинация с други изделия.................... 21
3.1.5 Информация за безопасност по отношение на употребата ........................................................................................... 21
3.1.6 Безопасно изхвърляне .......................................................................................................................................................................... 21
3.2 Потенциални последици за здравето........................................................................................................................................................ 22
4 ИНСТРУКЦИИ ЗА УПОТРЕБА........................................................................................................................................................................................ 22
4.1 Общ преглед на лечението на криво стъпало....................................................................................................................................... 22
4.2 ОГ Mitchell Ponseti®................................................................................................................................................................................................ 23
4.3 Абдукционен лост Ponseti®............................................................................................................................................................................... 24
5 ПОДГОТОВКА....................................................................................................................................................................................................................... 24
5.1 Как се транспортира и съхранява продуктът........................................................................................................................................ 24
6 ПОДДРЪЖКА ....................................................................................................................................................................................................................... 24
6.1 Повторно използване на изделието .......................................................................................................................................................... 24
6.1.1 Почистване на изделието .................................................................................................................................................................... 25
6.2 Как да инспектирате продукта....................................................................................................................................................................... 25
7 ОТСТРАНЯВАНЕ НА НЕИЗПРАВНОСТИ .................................................................................................................................................................. 25
7.1 Как да идентифицирате и решавате проблеми ................................................................................................................................... 25
7.1.1 Отстраняване на неизправности от неквалифицирани лица........................................................................................ 25
7.2 Често задавани въпроси.................................................................................................................................................................................... 25
8 РЕЧНИК НА ТЕРМИНИТЕ................................................................................................................................................................................................. 26
9 ЛЕГЕНДА ЗА ИКОНИТЕ..................................................................................................................................................................................................... 27

15Документ MD-124
ОТКАЗ ОТ ОТГОВОРНОСТ
MD Orthopaedics не прави никакви декларации и не дава гаранции по отношение на това ръководство и изрично ограничава,
в максимално допустимата от закона степен, отговорността си за нарушаването на каквато и да било гаранция, която може да
бъде подразбрана при подмяната на настоящото ръководство с друго. Освен това MD Orthopaedics си запазва правото да
редактира тази публикация по всяко време, без да поема задължение да уведомява когото и да било за въпросната редакция.
Като дизайнер и производител на продукти, MD Orthopaedics не предоставя медицинско лечение и/или съвети. Информация за
рисковете и ползите от медицинско лечение, включително лечение, която включва употребата на продукти на MD Orthopaedics
и наличните алтернативи, се предоставя единствено от лекари или други медицински специалисти. Ако имате въпроси относно
лечението на вашето дете, важно е да обсъдите тези въпроси със съответния медицински специалист.
MD Orthopaedics не гарантира и не може да гарантира конкретни резултати от употребата на своите продукти.
Информацията, предоставена в настоящата документация, съдържа общи описания и/или технически характеристики за
функционалността на продуктите, описани в нея. Тази документация не е предназначена като заместител и не трябва да се
използва за определяне на годността или надеждността на тези продукти за конкретни потребителски приложения. Задължение
на всеки такъв потребител е да извърши подходящ и пълен анализ на риска, както и оценка и изпитване на продуктите по
отношение на съответното конкретно приложение или употреба. Нито MD Orthopaedics, нито който и да било от нейните филиали
или дъщерни дружества не носи отговорност за злоупотреба с информацията, която се съдържа в настоящата документация.
Ако имате предложения за подобрения или изменения или сте открили грешки в тази публикация, моля, уведомете ни.
При използването на този продукт трябва да се спазват всички съответни държавни, регионални и местни разпоредби за
безопасност. От съображения за безопасност и за да се осигури съответствие с документираните системни данни, само
производителят може да извършва поправки на компоненти.
Когато изделията се използват за приложения с технически изисквания за безопасност, трябва да се спазват съответните
инструкции. Неспазването на тази информация може да доведе до нараняване или повреда на оборудването.
MD Orthopaedics е положила всички усилия, за да се погрижи етикетите, инструкциите за употреба, предоставянето, въвеждането
в експлоатация и рекламирането на изделия да не използват текст, наименования, търговски марки, илюстрации и фигуративни
или други знаци, които могат да подведат потребителя или пациента по отношение на предназначението, безопасността
и ефективността на изделието.
Copyright © 2022 MD Orthopaedics, Inc.
Всички права запазени. Никоя част от тази публикация не може да бъде възпроизвеждана, разпространявана или предавана под
каквато и да било форма или по какъвто и да било начин, включително фотокопиране, записване или други електронни или
механични методи, без предварителното писмено разрешение на издателя. За молби за разрешение пишете на издателя на
адреса по-долу.
MD Orthopaedics, Inc.
604 North Parkway Street
Wayland, IA 52654
САЩ
[phone]
www.mdorthopaedics.com
ТЪРГОВСКИ МАРКИ
Mitchell Ponseti® и Ponseti® са регистрирани търговски марки на MD Orthopaedics.
MD Orthopaedics е положила всички усилия да предостави информация за търговските марки на наименования на компании,
продукти и услуги, споменати в това ръководство. Търговските марки, показани по-долу, са получени от различни източници.
Всички търговски марки са притежание на съответните им собственици.
Общо уведомление: Някои наименования на продукти, използвани в настоящото ръководство, се използват само за
идентификация и е възможно да са търговски марки на съответните им компании.
1 ПРЕДГОВОР
1.1 Предназначение
Ортезата за глезен Mitchell Ponseti® (ОГ) и абдукционният лост Ponseti® представляват ортеза за глезена на крака, наричана
още шина Mitchell Ponseti®, предназначена за метода на лечение„Понсети“ за коригиране на вродено конско-варусно стъпало
(КВС) у бебета и деца на възраст, по-малка или равна на осем години. Шината е предназначена да предотврати рецидив (еквинусна
и варусна деформация на петата).
Шината Mitchell Ponseti® трябва да бъде предписана от лекар или доставчик на здравни услуги, обучен по метода „Понсети“ за
лечение на криво стъпало, и обикновено се носи в продължение на 23 часа на денонощие за период от три месеца след гипсиране,
а след това през нощта и по време на сън в продължение на 4 – 5 години или докато лекарят или доставчикът на здравни услуги
посочи, че изделието повече не е необходимо.

16 Документ MD-124
Клиничен ортезист, също така обучен за метода „Понсети“, може да асистира на лекаря или доставчика на здравни услуги при
определяне на правилния размер на ОГ за детето. Ортезистът може също така да обучи родителите и роднините на детето за
правилния начин на поставяне на ОГ върху крака на детето, какви са признаците за лошо прилягане или други проблеми, и как се
установява, че е време за преминаване към следващия размер.
Други членове на клиничния екип, обучени в метода„Понсети“ – медицински сестри, лекарски асистенти или други лицензирани
медицински специалисти, също могат да обучат родителите за правилното използване на шината Mitchell Ponseti® и да правят
необходимите корекции в прилягането или оразмеряването.
Родителите на детето, негови роднини или друго определено обгрижващо лице носят отговорност за спазване на предписания
режим на лечение по метода „Понсети“ от 23 часа на денонощие в продължение на три месеца, след това по време на сън или
дрямка през следващите 4 – 5 години или докато лекарят не посочи, че изделието вече не е необходимо.
1.2 Целева група пациенти и целеви потребители
Ортезата за глезен (ОГ) Mitchell Ponseti® и абдукционният лост Ponseti® на MD Orthopaedics са проектирани да се носят от
дете на възраст (≤8) години с криво стъпало, след като частта от лечението с гипсиране е завършена.
Този документ е предназначен за лекаря, ортезиста, клиничния екип, родителите и роднините на деца, които получават лечение
с ортезата за глезен (ОГ) Mitchell Ponseti® и абдукционния лост Ponseti®.
1.3 Клинични ползи
Методът„Понсети“ е нехирургичен процес за лечение на криво стъпало, разработен от д-р Игнасио Понсети. Методът използва
внимателна манипулация и гипсиране за постепенно изместване на крака в правилната позиция. Всяка седмица гипсът се сваля,
кракът внимателно се премества в следващата позиция и се отлива нов гипс. Този процес продължава до 6 – 8 седмици.
След периода на гипсиране, краката се държат в правилната позиция с помощта на абдукционна шина за крака (АШК). Шината се
състои от ортезата за глезен (ОГ) и свързващия абдукционен лост. Шината обикновено се носи по 23 часа в денонощието
в продължение на три месеца, след което се носи през нощта и по време на дрямка през деня за период до 4 – 5 години или както
е предписано от лекар, за да се гарантира, че корекцията ще остане трайна.
При правилно лечение и спазване на протокола за шиниране, предписан от лекаря, се очаква, че повечето случаи на криво
стъпало могат да бъдат коригирани, докато детето достигне 4- или 5-годишна възраст.
MD Orthopaedics не предоставя медицинско лечение и/или съвети. Информация за рисковете и ползите от медицинско лечение,
включително лечение, която включва употребата на продукти на MD Orthopaedics, следва да се предоставя единствено от лекари
или други квалифицирани медицински специалисти, които лекуват вашето дете. Ако имате въпроси относно лечението на вашето
дете, важно е да обсъдите тези въпроси със съответния медицински специалист.
1.4 Обяснение на предупрежденията за безопасност
„Внимание“ указва опасност с ниско ниво на риск, която, ако не бъде избегната, може да доведе до леко или умерено
нараняване.
Указва информация, която се счита за важна, но не е свързана с опасности.
1.5 Инструкции за задържане
Прочетете и разберете настоящото ръководство и неговите инструкции за безопасност, преди да използвате този продукт.
В противен случай може да се стигне до нараняване.
Спазвайте всички инструкции.
Продуктът следва да се използва само от лица, които са прочели и разбрали напълно съдържанието на настоящото потребителско
ръководство.
Уверете се, че всеки човек, който използва продукта, е прочел тези предупреждения и инструкции и ги спазва.
Производителят не носи отговорност за случаи на материални щети или наранявания, причинени от неправилна работа или
неспазване на инструкциите за безопасност. В такива случаи гаранцията ще бъде анулирана.
Настоящата политика / гаранция е непрехвърлима и покрива само нормалната амортизация. Измененията по продукта
и следпродажбени модификации ще анулират гаранцията. Моля, свържете се с нас, ако имате проблеми, които не са описани
в настоящата политика. Необичайните въпроси ще се разглеждат индивидуално.
1.6 Получаване на документация и информация
1.6.1 Поръчване на документация
Допълнителна документация, инструкции за потребителя и техническа информация могат да бъдат поръчани чрез обаждане до
MD Orthopaedics на [phone] или по имейл до inf[email protected].
1.6.2 Други езици
Инструкциите за употреба (IFU) са налични на други езици на www.mdorthopaedicsifu.com.

17Документ MD-124
1.6.3 Обратна връзка за документацията
Ако четете продуктова документация на MD Orthopaedics в интернет, можете да подадете всякакви коментари чрез уебсайта за
поддръжка. Коментарите могат да бъдат изпратени и на адрес [e-mail]. Оценяваме вашите коментари.
1.6.4 Поддръжка и сервиз
За въпроси, информация, техническа помощ или за да поръчате инструкции за потребителя, моля, свържете се с:
MD Orthopaedics, Inc.
604 North Parkway Street
Wayland, IA 52654
САЩ
www.mdorthopaedics.com
[phone] или на имейл [email protected]
1.6.5 Име и адрес на производителя
Следното физическо или юридическо лице прави изделието, за което се отнася настоящото потребителско ръководство,
подходящо за използване в рамките на Европейския съюз и е производител на изделието:
Ортезата за глезен Mitchell Ponseti® и абдукционният лост Ponseti® са произведени от:
MD Orthopaedics, Inc.
604 North Parkway Street
Wayland, IA 52654
САЩ
www.mdorthopaedics.com
[phone]
2 ОПИСАНИЕ НА ПРОДУКТА
2.1 Предназначение и разумно предвидима неправилна употреба
Шината Mitchell Ponseti® е медицинско изделие клас I, предназначено за употреба само върху деца, чието криво стъпало се
коригира по метода на лечение„Понсети“, и само по начина, предписан от лекар, напълно обучен за метода„Понсети“.
Шината Mitchell Ponseti® не бива да се използва без рецепта от лекар, обучен за метода„Понсети“, и трябва да се използва само
както е предписано.
Шината Mitchell Ponseti® не бива да се използва за лечение на други ортопедични състояния, различни от криво стъпало, освен
ако лекарят или ортезистът не е предписал друго.
Ортезата за глезен Mitchell Ponseti® трябва да се използва само със следните оригинални принадлежности и компоненти:
• Регулируем лост Ponseti®
oПредлага се с 10 или 15 градуса дорсифлексия.
• Омекотител за натиск: Този мек и удобен омекотител се прикрепя към средната каишка на ОГ Mitchell Ponseti®, за да осигури
допълнително облекчаване на зоните под натиск. Предлага се в малък и голям размер. Малкият размер се препоръчва за
използване с ОГ размер 0000-1; големият размер се препоръчва за използване с размери 2-12.
• Капак за лоста: Този мек капак осигурява защита и комфорт за вашето дете и се предлага в малък (5"/12,7 cm) и голям
(8"/20,3 cm) размер, в розово, светлосиньо или тъмносиньо.
Ортезата за глезен Mitchell Ponseti® се предлага в четири стила:
ОГ Mitchell Ponseti® Standard използва метода„Понсети“ за коригиране на кривото стъпало. Нашата патентована система включва
мека подплата за комфорт и напасване, меки каишки от синтетична кожа. Местоположението на петата може лесно да се види
през двата отвора за наблюдение в задната част на ОГ. ОГ се носи прикрепена към абдукционния лост Ponseti® в съответствие
със стандартния протокол за шиниране„Понсети“. Предлага се в размери от такъв за преждевременно родени (preemie) до 12.
ОГ Mitchell Ponseti® Plantar Flexion Stop: Артикулираният стопер за плантарна флексия ограничава плантарната флексия с твърда
дорзифлексия, за да поддържа предписаната позиция на стъпалото. Препоръчва се при комплексно криво стъпало. Това изделие
е подходящо и за деца с хипергъвкави крака, тъй като гарантира, че стъпалото винаги се държи в неутрално или дорзфлексирано
положение. ОГ се носи прикрепена към абдукционния лост Ponseti® в съответствие със стандартния протокол за шиниране на
„Понсети“. Предлага се в размери от 00 до 12.
ОГ Mitchell Ponseti® Toe Stilt е специално разработена по препоръка на д-р Понсети за поддържане на клинично желаната
дорзифлексия чрез разтягане на ахилесовото сухожилие и подпомагане на поддържането на гъвкавостта на стъпалото. Това се
постига чрез поставянето на вграден клин, прикрепен към предната част на ОГ, който поддържа двата крака в дорзифлексно
положение от 10 градуса, докато потребителят стои прав. ОГ се носи прикрепена към абдукционния лост Ponseti® в съответствие
със стандартния протокол за шиниране„Понсети“. Пациентът трябва да може да стои независимо, за да има някакъв ефект ОГ Toe
Stilt, когато се използва без абдукционен лост Ponseti®. Предлага се в размери от 2 до 11.

18 Документ MD-124
Mitchell Ponseti® Plantar Flexion Stop/Toe Stilt е ОГ с двойно предназначение, която подкрепя метода„Понсети“ за лечение на криво
стъпало. ОГ се носи прикрепена към абдукционния лост Ponseti® в съответствие със стандартния протокол за шиниране
„Понсети“. Стоперът за плантарна флексия (СПФ) е проектиран да ограничи структурно всякаква плантарна флексия и работи
особено добре при криво стъпало с хипермобилна или коригирана атипична/сложна деформация. СПФ се монтира
на стандартната ОГ по време на процеса на сглобяване, но е проектиран така, че да бъде персонализиран от ортезиста,
ако е необходимо, за да отговори на динамичните нужди на всяко дете с криво стъпало. Toe Stilt насърчава разтягането на долната
част на прасеца, ахилесовото сухожилие и плантарната фасция при малкото дете, което може да стои право самостоятелно без
абдукционния лост Ponseti®. Toe Stilt държи двата крака с 10 градуса дорзифлексия, когато потребителят стои прав. Предлага се
в размери от 2 до 11.
Обучението за правилното прилагане на шината и отстраняване на проблеми с кожата е от решаващо значение, за да се
гарантира, че корекцията на кривото стъпало на вашето дете е ефективна. НЕ ИЗПОЛЗВАЙТЕ това изделие, без преди това
да сте били обучени от своя лекар или клиничен екип. Свържете се с отдела за поддръжка на клиенти за помощ при
намирането на ресурси за обучение.
2.2 Състояние и начин на стерилизация
Не е приложимо, тъй като шината Mitchell Ponseti® не е стерилен продукт.
2.3 Обобщение на безопасността и клиничните показатели
Шината Mitchell Ponseti® е неимплантируемо изделие от клас I. Поради това не се изисква обобщение на безопасността
и клиничните показатели.
2.4 Технически характеристики
ОГ Mitchell Ponseti® е проектирана с мека, контурна еластомерна подложка, за да служи като възглавница и да задържа крака на
детето на място. Каишките и тялото, изработено от еластичен синтетичен велур, прилягат към формата на крака за допълнителен
комфорт и стабилност. ОГ има отвори отстрани за осигуряване на вентилация и охлаждане на крака, както и отвори за наблюдение,
за да улесни правилното поставяне на петата в ОГ.
ЗАБЕЛЕЖКА: Чорапите са задължителни за предотвратяване на контакта на кожата с продукта.