7
CE Conformity
This product meets the requirements of 93/42/EEC 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. Please keep this manual in safe place
for future use.
7.1
Have the patient pre-scheduled for a 2-week follow-up appointment, as the brake sensitivity and
the knee movement may change due to initial wear in period. It is recommended that readjustment
of the knee joint’s settings again be verified after the patient has spent a period of time getting used
to the prosthesis after another 3-4 weeks.
7.2
It is recommended to perform routine annual safety checks. Should issues arise in regards to
parts or repairs, please contact with your distributor or ST&G USA Corp.
7. Service and Repair
ST&G USA Corporation Warranty applies only when the product is used according to the specified
conditions and for the intended purposes, following all manufacturer’s recommendations. We offer a
warranty of 2 years
