Safety Information When Using The Device In Combination With Other Devices; Safety Information Regarding The Use; Safe Disposal; Potential Health Consequences - MD Mitchell Ponseti Gebrauchsanweisung

3.1.4 Safety information when using the device in combination with other devices

• The Mitchell Ponseti® Ankle Foot Orthotic shall be used with the following original accessories and components only:
Ponseti® Abduction Bar
o
Mitchell Spring Assist Dobbs Bar
o
Pressure Saddles
o
Ponseti® Bar Covers
o
Altering the product and/or making after-market modifications 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® Ankle Foot Orthotic 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 years or as
directed by your physician.
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.
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
1-877-766-7384
6 Document MD-124