Description Of Symbols; Regulatory Information - PROTEOR Freedom ShockWave F20 Instrucciones De Uso

7 DETECTION OF MALFUNCTIONS
If you notice any abnormal behavior or feel any changes in the characteristics of the device, or if the device has received a severe
impact, consult your prosthetist.
8 WARNINGS, CONTRAINDICATIONS, AND SIDE EFFECTS
A. Warnings
Inappropriate use of the device, in relation to the recommendations of your prosthetist, can cause the degradation of parts
of the foot (carrying heavy loads for example, excessive stress, exceeding the service life, etc.).
Never use the foot module without a foot shell.
Never attempt to loosen the bolts affixing the pyramid connector.
Water resistant: The device will withstand occasional submersion and is splash resistant.
B. Contraindications
The device is inappropriate for users who do not meet the requirements of a Medicare functional level of K3 or higher.
This device is not intended for activities where there is a risk of severe impact or excessive overload.
C. Side effects
There are no known negative side effects.
Any serious incident that has occurred in relation to the device should be reported to the manufacturer and the
competent authority.
9 MAINTENANCE, STORAGE, DISPOSAL, AND DURABILITY
A. Maintenance / Cleaning
No maintenance operation such as lubrication, work on the screws, or other parts is required.
Inspect the foot module every six months. If the user is more active, more frequent inspection may be necessary. Service as
necessary. Replace sock and/or foot shell if worn to prevent damage to the composite components.
The foot module may be cleaned and/or disinfected with soap and warm water.
Do not allow aggregates such as sand to remain in the foot shell. Upon exposure to aggregates, immediately disassemble foot
module and rinse with water. The abrasive properties of aggregates will wear the composite components of the foot module.
After use in water:
•
Remove the foot shell and take off the sock
•
Rinse the foot with clean water
•
Dry well
B. Storage
Storage and operating temperature range: -29 to 49° C [-20 to 120° F]
Storage and operating relative humidity range: No restrictions.
C. Disposal
The different items of the foot are special wastes and must be handled according to local laws.
D. Durability
Purchase of the Freedom ShockWave includes a 36-month warranty covering all manufacturer defects effective only if the
product is used according to manufacturer recommendations. The foot shell is covered for 6 months. Failure to adhere to the
guidelines of the Instructions for Use will void the warranty.

10 DESCRIPTION OF SYMBOLS

Manufacturer

11 REGULATORY INFORMATION

This product is a tested and certified to comply with MDR 2017/745, ISO 10328, and carries the CE mark.
INSTRUCTIONS FOR USE
Warning
Page 3 of 3
CE marking and year of 1
declaration
st