Olympus Winter & Ibe GmbH ESG200 User Manual

Page of 110
76
Reprocessing
11 Reprocessing
11.1 General information for reprocessing
Brand-new products
Treat brand-new products as if they have been used. Brand-new products must be 
reprocessed using a complete reprocessing cycle.
The reprocessing cycle
 
• Reprocess the product according to the instructions in this chapter.
 
• To minimize the risk of infecting patients, users or third parties, reprocess the product 
before each use.
 
• Contact your local hygiene representative for local standards and regulations.
Validated for efficacy
Validated for efficacy means that the efficacy of the method or agent has been validated for 
reprocessing this product as described in this document.
Verified for material compatibility
Verified for material compatibility means that according to current knowledge the 
reprocessing method or agent does not negatively affect materials or functional performance 
of the product.
Verified for material compatibility does not mean that microbiological efficacy can be 
guaranteed.
Instructions for using reprocessing agents
 
• The reprocessing agent must be approved by the manufacturer for cleaning and 
disinfection of medical devices and for the material to bei reprocessed.
 
• Refer to national and local guidelines regarding the approval of using alcohol as 
reprocessing agent.
 
• Select contact times and concentrations of the reprocessing agent in accordance with the 
instructions given by the manufacturer.
 
• The reprocessing agent must be approved and validated by the FDA, the EPA, the DGHM 
or a comparable institution for its efficiency.
 
• Reprocessing may lead to an increased wear of the product. Before use, thoroughly 
inspect the products for traces of wear.
11.2 Cleaning
Suitable reprocessing agents for cleaning
Cleaning efficacy has been validated with an alkaline disinfectant based on low alcohol 
(<20%) and quaternary ammonium compounds (Sani-Cloth
®
 Plus manufactured by PDI 
Professional).
Material compatibility has been verified with the following reprocessing agents:
 - Alkaline agents, max. pH value of 12,0
 - Neutral agents
Cleaning procedure
Perform the following cleaning procedure immediately after use. If cleaning is delayed, 
debris will solidify and it may be difficult to effectively clean the surfaces.
1.  Take a soft, lint-free cloth that is soaked with a suitable reprocessing agent.
2.  Thoroughly wipe the surfaces of the electrosurgical generator until visibly clean.
DRAFT 
– 
2017-01-17