FujiFilm EN-580T User manual

Endoscope
EN-580T
Thank you for purchasing our product. Read this manual carefully before use to avoid
unexpected accidents and to take full advantage of the product's capabilities.
English
OPERATION MANUAL
(Preparation and Operation)

Important Safety Information
1. Intended Use
This product is a medical endoscope intended for observation, diagnosis and
endoscopic treatment of the esophagus, stomach, duodenum, small intestine and large
intestine in medical facilities under management of physicians. Do not use this product
for any other purpose.
2. Safety
Read and understand this manual carefully before use. Use the endoscope by following
the provided instructions. Items important for the safe use of the endoscope are
summarized in Chapter 1 “Safety.”
Safety precautions associated with individual operations or procedures are provided
separately, indicated “ WARNING” or “ CAUTION.”
3. Warning
Items that must be observed for safety when performing endoscopy or electrosurgery
are identied by “ WARNING” or “ CAUTION.” Perform procedures correctly
by reading and understanding the warning information carefully.
WARNING
Read and understand this manual carefully before
operating the equipment.
Improper use or operation of the equipment may
injure patients, physicians, or people in the vicinity.
Improper operations that will damage the equipment only are identified by
“CAUTION.”
Important Safety Information
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4. Clinical Procedures
This manual assumes that the product will be used by medical specialists who
have received proper training in endoscopic procedures. When performing
observation, diagnosis and endoscopic treatment of small intestine, refer to general
contraindications to upper gastrointestinal tract endoscopy and colonoscopy. In
addition, if the general condition of the patient is extremely critical, or if there are
any risks involved in performing the endoscopic examination of ileus, gastrointestinal
perforation, respiratory disease, cardiovascular disease, Crohn's disease, acquired
hemophilia, stenosis, large ulcer, tumor, etc., perform endoscopy only when the
benets outweigh the risks. This manual does not provide information about clinical
procedures. Regarding clinical procedures, use proper clinical judgment.
5. When Using the Endoscope for the First Time
This product has not been sterilized. When using it for the rst time, use the level
of disinfection or sterilization suitable to the application, in accordance with
Chapter 7 “Cleaning,” Chapter 8 “Chemical Disinfection,” and Chapter 9 “Gas
Sterilization.”
6. Single Patient Use Only
The Over-tube, balloon, setting tool ST-05B and forceps valve are intended for single
patient use. To prevent infection, do not reuse them.
7. Treatment with Electrosurgical Instruments
Before electrosurgery, basic in vitro experiments must be performed to learn how
to tighten the snare properly and how repeated use affects the cutting quality of
endotherapy devices.
8. Use of Over-tube and Balloon
When the balloon is swollen too much, the enteric canal might be hurt.
When using the Over-tube and balloon, the operator should conduct sufcient basic
experiments outside the body and learn the degree of ination of the balloon before
using it.
Important Safety Information
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9. Latex Allergy
WARNING
Do not use Over-tubes and balloons on patients
allergic to latex.
There is a risk of an anaphylactic reaction/shock.
This product is used with a product that contains natural rubber as a material. Natural
rubber may rarely cause allergy symptoms, such as itching, reddening, hives, swelling,
fever, dyspnea, asthma-like symptoms, drop of blood pressure and shock. If such
symptoms are observed, stop use immediately and take appropriate measures.
10. Use of Personal Protective Equipment
Patient's body fluids adhering to endoscopic accessories such as balloons used in
combination with this product may splash, resulting in infection to the operator or
assistant. Wear appropriate personal protective equipment when attaching or removing
endoscopic accessories.
11. If Any Abnormality Occurs During Clinical Procedure
If any abnormality occurs with the equipment, refer to “Troubleshooting.” In
particular, continuing to use this product even after it displays abnormal images may
cause overheating of the distal end, resulting in burns or other injury.
Important Safety Information
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12. Loss of Function
During an examination, if the endoscopic image disappears, a live image is not
displayed after freeze mode has been cancelled, or the endoscopic image is discolored,
reset the processor and light source.
During treatment, if the endoscopic image disappears, a live image is not displayed
after freeze mode has been cancelled, or the endoscopic image is discolored, stop
treatment immediately, remove the endotherapy device from the endoscope, and then
reset the processor and light source.
If an appropriate image does not appear even after resetting the processor and light
source, turn them off, straighten the bending portion to unlock, release the angle knobs,
and then withdraw the endoscope slowly from the patient.
Should the endoscopic image disappear during an examination or treatment, and if the
processor and light source are not turned off, it may cause overheating of the distal end
of the endoscope, possibly resulting in mucosal burns or other injury.
[Note] Reset: Turn off the processor and the light source, and wait for at least 5 seconds.
Turn on the processor and the light source again, and then light the lamp by pressing
the Lamp button.
Important Safety Information
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