Adept Medical AM0180 Gebrauchsanweisung Handbuch - Seite 8
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Approved Cleaners List
Approved Disinfectant by Brands
Liquids:
Dissolvable:
ORION Laboratories
Du Pont
70% Isopropyl Alcohol
Rely+On Virkon Tablets
Jaychem Industries
2% Chlorhexidine / 70% Alcohol
Betadine
Povidone Iodine (7.5%)
BODE Chemie GmbH
Kohrsolin FF
STERIS
Coverage Spray TB
CaviCide
Metrex Research
Approved Active Disinfectant Ingredients
Acid Based:
≤10% Malic Acid CAS 6915-15-7
≤6% Sulfamic acid CAS 5329-14-6
Alcohol Based:
≤5% 2-Butoxyethanol CAS 111-76-2
≤10% Butyldiglycol CAS 112-34-5
≤70% Isopropyl Alcohol (Propan-2-ol) CAS 67-63-0
≤10% Tridecanol CAS 69011-36-5
<10% Alcohols, C12-14, ethoxylated CAS 68439-50-9
≤70% Denatured Ethanol CAS 64-17-5
Sulphate Based:
≤0.1% PHMB CAS 27083-27-8
≤55% Potassium Peroxymonosulfate CAS 70693-62-8
≤3% Potassium Persulfate CAS 7727-21-1
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Surface Wipes:
PDI Sani-Cloth Bleach
PDI Sani-Cloth AF3
Reynard Health Supplies
Surface Disinfectant Wipes
Metrex Research
CaviWipes
Clinell Wipes - Universal (Green)
Clorox Hydrogen Peroxide Wipes
Ammonium and Chloride Based:
≤5% Benzalkonium Chloride CAS 68424-85-1
≤0.28% Benzethonium Chloride CAS 121-54-0
≤10% Benzyl-C23-18-Alkyl-dimethyl Ammonium Chloride
CAS 8001-54-5
≤2% Chlorhexidine CAS 55-56-1
≤10% Didecyl Dimethyl Ammonium chloride CAS 7173-51-5
≤0.5% Quaternary Ammonium Compounds CAS
68956-79-6
<5% Benzyl-C 12-18 alkyldimethylammonium chlorides
CAS 63891-01-5
Others:
≤10% Glutaral CAS 111-30-8
≤0.63% Sodium Hypochlorite CAS 7681-52-9
≤7.5% Povidone Iodine CAS 25655-41-8
0.5% Disodium Cocoampho Dipropionate CAS68604-71-7
≤1.4% Hydrogen Peroxide CAS 7722-84-1
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Drying
All components should be dried thoroughly
before use.
Maintenance, Inspection and Testing
All components:
●
Ensure no visible damage or sharp edges,
e.g. cracks.
STARBoard, X-Ray Shield:
●
Ensure no exposed Carbon Fibre is visible.
STARBoard:
●
Ensure all pivoting joints can rotate with
the appropriate amount of friction and
adjust if necessary.
Extension Tray:
●
Ensure the Extension Tray is correctly
attached and secure on the STARBoard.
Packaging
It is not required to package the device following
disinfection.
Sterilisation
This device should not be subjected to
sterilisation processes.
Storage
Once disinfection is complete and all
components are dry the device should be stored
in a dry environment.
The instructions provided above have been validated
!
by the manufacturer of the medical device as being
capable of preparing a medical device for reuse. It
remains the responsibility of the processor to ensure
that the processing, as actually performed using
equipment, materials and personnel in the processing
facility, achieves the desired result. This requires
verification and/or validation and routine monitoring
of the process.
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Disposal
Used product is a biohazard, decontaminate
according to instruction provided in the
Disinfection Instructions and reach out to the
manufacturer on [email protected]
for material specification, if required. Dispose
according to internal clinic policy taking into
consideration local regulations.
Serious Incidents
Any serious incident which occurs in relation to
the device should be reported immediately to:
●
The Competent Authority of the
applicable Member State.
●
The Manufacturer using the Serious
Incident Reporting Form found on the
Adept Medical Website.
Serious
Incidents Form
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