23
3. If contaminants are still visible on the product after the end
of the routine, repeat precleaning and machine cleaning.
5.7 Check
1. Check the product for visible damage and wear:
– Damage to the product, e.g. cracks, rough surface, splin-
tering.
– Damage to the product insulation and/or cable/connec-
tor insulation, e.g. cracks and breaks.
2. Check the mechanical functionality of the product:
– Can the pedals and ReMode button be pressed?
If damaged, do not use this product!
5.8 Overview of Validated Procedures
The following procedures have been validated as suitable for
processing the product:
•
Manual cleaning/disinfection with the detergent neodisher
mediclean forte (Dr. Weigert GmbH & Co. KG, Hamburg/Ger-
many) and disinfectant Cidex OPA (Johnson & Johnson Med-
ical Limited, Gargrave, Skipton).
– neodisher mediclean forte: Dosage ½ oz/gallon of warm
tap water, 5 minutes exposure time at room temperature.
– Cidex OPA: Minimum effective concentration (MEC)
0,3%, 12 minutes exposure time at 61-68 °F (16-20 °C).
•
Cleaning by machine in a STERIS Reliance Genfore washer/
disinfector GEN FH07-1XX (STERIS Corporation, Mentor OH,
USA) using neodisher mediclean forte detergent (Dr. Weigert
GmbH & Co. KG, Hamburg/Germany).
– Prewash: 2 minutes under cold tap water.
– Main wash: 5 minutes at 140°F (60°C) with neodisher
MediClean forte, dosage ¼ oz/gallon.
– Final rinse: 1 minute under hot tap water.
– Product drying: 7 minutes at 158°F (70°C).
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