FujiFilm EB-530US, Руководство по эксплуатации

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12) Temperature at distal end
When the Ultrasonic Endoscope projects light at high brightness and transmission of
ultrasonic waves for a long time, the temperature may exceed 41°C at the distal end. Turn
off the lamp and stop transmission of ultrasonic waves (Freeze the ultrasonic processor)
when you hang the Ultrasonic Endoscope on the cart hanger.
13) Electromagnetic interference
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.
This equipment complies with the requirements of EN 60601-1-2:2001+A1:2006 when
connected to VP-4400, XL-4400, EPX-2500 and SU-7000.
2. Cleaning and Disinfection/Sterilization
This product has not been sterilized. When using it for the first time, perform cleaning,
disinfection and or 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 water feed channel
especially.
Wear protective gear during chemical cleaning and disinfection to protect your eye and 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.
Chapter 1 Safety
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EB530US_E2_202B1237458F.indb 4 2013/12/23 11:50:48