Otto Bock 6Y44, Instructions For Use Manual

Page: 8 / 92

3) Unroll the liner onto the residual limb without displacing the soft
tissue and without leaving wrinkles or air pockets.
4) Check the fit and the alignment of the liner.
Doffing
1) Roll up the liner and remove it from the residual limb.
2)
Recommendation: Clean the liner (see page 8).
6.5 Cleaning and Care
NOTICE
Use of improper cleaning agents
Damage to the product due to use of improper cleaning agents
► Only clean the product with the approved cleaning agents.
INFORMATION
Wearing a liner requires daily intensive skin care. Ottobock recom­
mends the Derma skin care products.
1) Turn the liner inside out.
2) Hand wash the liner in warm water (
30 °C ) using neutral deter­
gent (e.g. 453H10=1 Ottobock Derma Clean).
3) Thoroughly rinse the liner with clear water until all detergent
residues have been removed.
4) Turn the liner again so the outer side is on the outside.
5) Put a towel into the liner and allow the liner to dry lying flat on a
drying rack. Alternatively, use a drying stand (TT: 5Y100=1, TF:
5Y100=2).
7 Reprocessing
INFORMATION
Provide the instructions for sterilisation of the product to the
person performing this task.
The liner must be reprocessed before using it on another patient. The
liner is sterilised to eliminate all pathogens from the previous patient.
8
Subsequent non-sterile storage of the liner is permissible. The pro­
cess is defined in the DIN EN ISO 17665-1:2006-11 standard.
The liner may be reprocessed six times.
>
Prerequisite:
The liner has been cleaned.
1) Fill the liner with paper so it stays open during the process.
2) Put the liner into a bag and seal the bag.
3) Prepare and label the sterilisation test set.
4) Perform sterilisation in the autoclave (recommendation:
121 °C
,
15 psi , 30 minutes ).
INFORMATION: Ottobock does not recommend sterilisation
with ethylene oxide.
5) Store the liner according to hospital standards.
8 Disposal
In some jurisdictions it is not permissible to dispose of the product
with unsorted household waste. Improper disposal can be harmful to
health and the environment. Observe the information provided by the
responsible authorities in your country regarding return, collection
and disposal procedures.
9 Legal information
All legal conditions are subject to the respective national laws of the
country of use and may vary accordingly.
9.1 Liability
The manufacturer will only assume liability if the product is used in
accordance with the descriptions and instructions provided in this
document. The manufacturer will not assume liability for damage
caused by disregarding the information in this document, particularly
due to improper use or unauthorised modification of the product.
9.2 CE conformity
The product meets the requirements of Regulation (EU) 2017/745 on
medical devices. The CE declaration of conformity can be down­
loaded from the manufacturer's website.