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Chapter 1 Safety
12) Electromagnetic interference
2. Cleaning and Disinfection/Sterilization
1-4
This equipment has been tested and found to comply with the limits for medical devices
defined in EN 60601-1-2:2007. These limits are designed to provide reasonable protection
against harmful interference in a typical medical installation. However, it is possible that it
may cause harmful interference to other devices in the vicinity, if it is installed and used in
accordance with the instructions. Also, there is no guarantee that interference will not occur
in a particular installation. Therefore, if this equipment does cause harmful interference to
other devices, which can be determined by turning the equipment off and on, the user is
encouraged to try to correct the interference by one or more of the following measures:
•
Change the orientation or position of any affected device.
•
Increase the spacing between devices.
•
Consult the manufacturer or dealer of the device.
Noise may appear on the monitor of this equipment due to the effect of electromagnetic
waves. In this case, turn off the device emitting the electromagnetic waves or move the
device away from this equipment.
Perform cleaning, disinfection and sterilization of the endoscope according to respective
guidelines. Clean and disinfect the endoscope after understanding the latest guidelines.
This product has not been sterilized. When using it for the first time, perform cleaning,
disinfection and sterilization suitable for the application.
After using it, clean and disinfect/sterilize it according to the procedures in the manual
(Cleaning, Disinfection and Storage). Inadequate cleaning may result in infection. Carefully
clean the insertion portion and all the channels including the balloon air feed channel
especially.
Wear personal protective equipment during chemical washing and disinfection to protect
your skin and to prevent infection.
When using this product for a patient with Creutzfeldt-Jakob disease (especially variant
Creutzfeldt-Jakob disease), use it exclusively for a patient with the same disease, or
properly discard this product after use. Since the cleaning, disinfection and sterilization
methods described in the manual (Cleaning, Disinfection and Storage) of this product
cannot eliminate the causal agents of Creutzfeldt-Jakob disease, the product could be a
source of infection. For the treatment of Creutzfeldt-Jakob disease, refer to the guidelines
for it available.
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