Scope Of Delivery; Signs Of Changes In Or Loss Of Functionality During Use - Otto Bock Harmony E2 4R152 Instructions For Use Manual

CAUTION
Excessive strain on the product
Risk of injury due to breakage of load-bearing components
► Use the product according to the specified area of application (see Page 16).
CAUTION
Unallowable combination of prosthetic components
Risk of injury due to breakage or deformation of the product
Only combine the product with prosthetic components that are approved for that purpose.
►
Based on the instructions for use of the prosthetic components, verify that they may be com­
►
bined with each other.
CAUTION
Use under unallowable environmental conditions
Risk of injury due to damage to the product
Do not expose the product to unallowable environmental conditions.
►
If the product has been exposed to unallowable environmental conditions, check it for dam­
►
age.
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
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

Among other factors, changes in functionality can be indicated by an altered gait pattern, a
change in the positioning of the prosthetic components relative to each other and by the develop­
ment of noises.

4 Scope of delivery

Fig. Item
1 1
2 –
4R152* Harmony E2 (see fig. 1)
Quantity Designation
1 Harmony E2 vacuum pump
1 Adapter plate set
Reference number
–
4R153 or 4R153=1
17