9
CAUTION
Use under restricted environmental conditions
Risk of injury due to damage to the product
►
Do not expose the product to restricted environmental conditions.
►
If the product has been exposed to restricted environmental conditions, check it for damage.
►
If damage is apparent or in case of doubt, do not continue using the product.
►
Take suitable measures if required (e.g.cleaning, repair, replacement, inspection by the
manufacturer or a specialist workshop etc.).
CAUTION
Exceeding the service life and reuse on another patient
Risk of injury due to loss of functionality as well as damage to the product
►
Ensure that the approved service life is not exceeded.
►
Only use the product on a single patient.
CAUTION
Reaching into the area of the joint mechanism
Pinching of limbs (e.g. fingers) and the skin due to uncontrolled joint movement
►
Do not reach into the joint mechanism during daily use.
►
Close attention is required during assembly and adjustment tasks.
CAUTION
Mechanical damage to the product
Risk of injury due to change in or loss of functionality
►
Use caution when working with the product.
►
If the product is damaged, check it for proper function and readiness for use.
►
In case of changes in or loss of functionality, do not continue using the product (see "Signs
of changes in or loss of functionality during use" in this section).
►
Take any necessary measures (e.g. repair, replacement, inspection by the manufacturer's
customer service, etc.).
Signs of changes in or loss of functionality during use
Noticeable changes in functionality may include poor response, incomplete extension, diminished
swing phase control or stance phase stability, abnormal noises, etc.
4 Scope of delivery
The following single components and accessories are included in the scope of delivery in the spe
cified quantities and are available for reordering as single components ( ), single components
with minimum order quantities ( ) or single-component packs ( ):
Fig. Item no. Quant
ity
Designation Reference number
1
–
1 Prosthetic Knee Joint –
– – 1 Instructions for Use 647G556=all_INT
– – 1 Quick reference guide 646D1537=all_INT
The following parts are only for: Prosthetic Knee Joint 3R78=KD
1 1 Lamination Anchor 4G149
1 2 Set Screw 506G3=M8X10
1 4 Truss Head Screw 501T1=M5X16
1 4 Two-Hole Nuts 502R1=M5X16