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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
benefits 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 first 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 sufficient basic
experiments outside the body and learn the degree of inflation of the balloon before
using it.
Important Safety Information
3
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