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Manual cleaning / disinfection
Notes regarding the use of cleaning agents and disinfect-
ants
•
Prepare the cleaning and disinfection solutions prior to each
manual cycle.
•
Use de-ionised water.
Procedure validated by the manufacturer:
1.
Prepare a 2% (30 ml/
l
) cleaning and disinfection solution of
“Sekusept
®
Aktiv” with de-ionised water at 20 °C (68 °F).
After 15 min the cleaning and disinfection solution can be
used.
2.
Clean the products with soft sponges in the cleaning and disin
-
fection solution. Areas difficult to access must be cleaned with
soft brushes. Hard brushes and other materials which may
damage the surface of the products must not be used.
3.
Place the products into the cleaning and disinfection solution
and leave for 15 min. Ensure all hollow spaces are covered
with solution.
4. Remove cleaning and disinfection solution by rinsing thor-
oughly with de-ionised water. Remaining residues can shorten
the product shelf life or can lead to material damage.
5.
Dry the products. Avoid any accumulation of water.
6.
Check for visible contamination. If necessary, repeat the repro
-
cessing.
7.
Check the products according to the section “Checks” and
prepare them for sterilisation (see section “Packaging”).
Checks
After disinfection and before every use, the products must be
inspected for damage (cracks, breakages, etc.).
Damaged products must not be reused.
Packaging
After the cleaning and disinfection procedure, the products must
be packed into a package which is suitable for steam sterilisation.
Sterilisation
Notes regarding sterilisation:
•
Products or sterilisation packages must be protected from
mechanical damage.
Sterilisation validated by the manufacturer
•
The products must be steam sterilised by a fractionated vacuum
process.
•
Exposure time is 5 min with a sterilisation temperature of
134 °C (273 °F).
Reusability
The end of the shelf life for reusable products is basically deter
-
mined by wear and damage caused by its use. Considering the
maximum shelf life of 5 years, reusable products can be repro
-
cessed up to 100 times if used properly and if the cleaning, disin
-
fection and sterilisation instructions are complied with.
Every further reuse is the responsibility of the user (see section
“Checks”).
WARNING
By using the products on patients with suspected prion
disease there may be a high risk of transmission. In such
case the physician decides if the product is either dis
-
posed of (see section “Disposal”) or reprocessed accord
-
ing to national directives.
A list with compatible cleaning agents is available at
www.vbm-medical.de in the download section.
SHELF LIFE
The shelf life of the product is 5 years and it can be reprocessed
100 times within the shelf life.
STORAGE AND TRANSPORT CONDITIONS
CAUTION
•
Protect from heat and store in a dry place.
•
Keep away from sunlight and light sources.
•
Store and transport in the original packaging.
SERVICE
Prior to the return of medical devices for complaints/repairs, the
products must have run through the complete reprocessing pro
-
cess to exclude any risk for the manufacturer's staff. For safety
reasons, the manufacturer reserves the right to refuse soiled or
contaminated products.
DISPOSAL
The used or damaged products must be disposed of in accordance
with the applicable national and international statutory regula
-
tions.
TECHNICAL DATA
35-60-000 35-60-001 35-60-002 35-60-003
Description
Newborn
Infant
Small child
Child
0
1
2
3
Material
Silicone
Connections
22 mm I.D.
Packaging
unit
10
Summary of Contents for 35-60-000
Page 7: ...7 60 Rendell Baker 1 2 a 20 C 1 min...
Page 9: ...9 60 35 60 000 35 60 001 35 60 002 35 60 003 0 1 2 3 22 mm 10...
Page 14: ...14 60 Rendell Baker MRI 1...
Page 16: ...16 60 35 60 000 35 60 001 35 60 002 35 60 003 0 1 2 3 22 mm 10...
Page 45: ...45 60 Rendell Baker 1...
Page 47: ...47 60 35 60 000 35 60 001 35 60 002 35 60 003 0 1 2 3 22 10...
