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English
REPROCESSING INSTRUCTIONS FOR REUSABLE PRODUCTS
SAFETY INFORMATION
•
Read and follow the instructions for use carefully before using the prod-
uct.
•
Products are supplied non-sterile and must be cleaned, disinfected and
sterilised prior to each use.
•
Manufacturer is not responsible for damages resulting from improper
reprocessing.
•
It rests with the user to validate their procedures, devices and acces
-
sories, and to comply with the validated parameters during every re
-
processing.
•
It is recommended to apply an automatic procedure due to a signifi
-
cantly higher efficiency of cleaning and disinfection.
•
The effectiveness has been verified by an independent and accredited
test laboratory.
•
To achieve a more effective reprocessing rough contamination must not
get dry on the product and must be removed immediately after use.
•
Do not bring silicone products in contact with oil and grease.
CLEANING / DISINFECTION
Automatic Cleaning / Disinfection
Notes regarding the use of washer disinfectors
•
Use de-ionized water.
Notes regarding the use of cleaning agents and disinfectants
•
By the use of alkaline cleaning agents, neutralisation must be performed.
•
Don’t use drying agents.
Procedure validated by the manufacturer
1. Place the products into the injector carriage:
Product group
Positioning in the injector carriage
•
Respiration tubing
Holder for spiral coil
•
Rebreathing bags
Injector jets
•
Silicone Hook
•
Connectors
•
Harness
•
Uncoupling Wedge
Mesh tray (securing with a cover net)
CAUTION
Ensure effective rinsing of all hollow spaces.
2. Start program with the following parameters:
a.
Rinse with de-ionized water at 20 °C (68 °F) with an exposure time of
1 min.
b.
Cleaning at 55 °C (131 °F) with an exposure time of 5 min using de-ion
-
ized water and the cleaner “Sekumatic
®
ProClean“ (Dose: 0,5 % (5 ml/
l
)).
c.
Neutralisation with “Sekumatic
®
FNZ“ at 20 °C (68 °F) with an exposure
time of 2 min (Dose: 0,1 % (1 ml/
l
)).
d.
Rinse with de-ionized water at 20 °C (68 °F) and an exposure time of 2 min.
e.
Thermal disinfection at 93 °C (199 °F) for 5 min with de-ionized water.
f.
Drying at 100 °C (212 °F) for 10 min.
3. Examine the products for visible contamination. If necessary repeat the repro-
cessing.
4.
Check the products acc. to the chapter “Control“ and prepare them for sterili
-
sation (see chapter “Packaging“).
Manual Cleaning / Disinfection
Notes regarding the use of cleaning agents and disinfectants
•
Prepare the cleaning- and disinfection solution before each manual cycle.
•
Use de-ionized water.
Procedure validated by the manufacturer
1.
Prepare a 2 % (30 ml/
l
) cleaning- and disinfection solution with “Sekusept
®
Aktiv” and de-ionized water at 20 °C (68 °F). The cleaning- and disinfection
solution is ready for use after 15 min.
2. Clean the products in the cleaning- and disinfection solution by using soft
sponges. Areas difficult to access must be cleaned with soft brushes. Hard
brushes and other materials which can damage the surface of the products
must not be used.
3. Put the products into the cleaning- and disinfection solution with an exposure
time of 15 min Ensure complete wetting of all hollow spaces.
4. Remove the cleaning- and disinfection solution by thoroughly rinsing with de-
ionized water. Remaining residues can shorten the product shelf life or can lead
to material damage.
5. Dry the products. Accumulation of water must be avoided.
6.
Check for visible contamination. If necessary repeat the reprocessing.
7.
Check the products acc. to the chapter “Control“ and prepare them for sterili
-
sation (see chapter “Packaging“).
CONTROL
After disinfection and prior to each use, the products have to be checked for dam
-
ages (cracks, ruptures etc.) and leaks. Damaged products must not be re-used.
PACKAGING
After the cleaning- and disinfection procedure the products must be packed into
a pouch which is suitable for steam sterilisation.
STERILISATION
Notes regarding sterilisation
•
Protect the products and sterilisation pouch against mechanical damage.
Sterilisation validated by the manufacturer
•
The products must be steam sterilised by a fractional 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 determined by wear and
damage caused by its use. Considering the maximum shelf life of 5 years, reus
-
able products can be reprocessed up to 100 times if appropriately used and under
adherence of the cleaning-, disinfection- and sterilisation instructions.
Every further reuse is in the responsibility of the user (see chapter “Control“).
WARNING
By using the products on patients with suspected prion disease there
might be a high risk of transmission. In such case the physician decides
if the product is either disposed (see chapter “Disposal”) or reprocessed
acc. to the national directives.
STORAGE AND TRANSPORT CONDITIONS
CAUTION
•
Product shelf life is 5 years.
•
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 return medical products for complaint/repair they must have run through
the complete reprocessing process to exclude any risk for the manufacturer’s
staff. For safety reasons, the manufacturer preserves the right to refuse soiled or
contaminated products.
DISPOSAL
Used or damaged products must be disposed acc. to applicable national and
international legal directives.
A list of compatible cleaning agents and a detailed symbol description are avail-
able at www.vbm-medical.de in the download section.
