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
2

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
3

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
4

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
5

Contents
(Preparation and Operation)
Important Safety Information ......................................................................................2
Preface .........................................................................................................................8
Conventions Used in This Manual...............................................................................8
Chapter 1 Safety................................................................................................... 1-1
Chapter 2 Composition of Set and System Conguration ................................... 2-1
2.1 Composition of Set..................................................................... 2-2
2.2 System Conguration ................................................................. 2-4
Chapter 3 Names and Functions of Parts............................................................. 3-1
3.1 Endoscope .................................................................................. 3-2
3.2 Symbols...................................................................................... 3-4
Chapter 4 Control Portion.................................................................................... 4-1
4.1 Operating Bending Mechanism.................................................. 4-2
4.2 Valve Control Buttons................................................................ 4-4
4.3 Switches for Images and Recording........................................... 4-5
4.4 Forceps Valve/Forceps Inlet....................................................... 4-6
Chapter 5 Preparation for Use of Endoscope....................................................... 5-1
5.1 Preparing Equipment.................................................................. 5-2
5.2 Preparing Forceps Valve and Button.......................................... 5-4
5.3 Connecting Endoscope ............................................................... 5-8
5.4 Inspecting Endoscope............................................................... 5-10
5.5 Inspecting Forceps.................................................................... 5-15
5.6 Inspecting Setting Tools ST-01B and ST-05B......................... 5-16
5.7 Attaching and Inspecting Over-tube and Balloon .................... 5-17
5.8 Inspecting Balloon.................................................................... 5-24
5.9 Connecting Balloon Controller ................................................ 5-25
Chapter 6 Method of Use..................................................................................... 6-1
6.1 Preparation.................................................................................. 6-3
6.2 Insertion and Observation .......................................................... 6-4
6.3 Biopsy....................................................................................... 6-15
6.4 Withdrawal ............................................................................... 6-18
6.5 Pre-cleaning (Primary Cleaning).............................................. 6-21
Contents
6

Appendix.....................................................................................................Appendix-1
Main Specications ................................................................Appendix-2
Troubleshooting......................................................................Appendix-8
After-Sales Service...............................................................Appendix-12
Disposal of Electric and Electronic Equipment....................Appendix-13
Index.....................................................................................Appendix-14
(Cleaning, Disinfection and Storage)
Chapter 7 Cleaning............................................................................................... 7-1
Chapter 8 Chemical Disinfection......................................................................... 8-1
Chapter 9 Gas Sterilization .................................................................................. 9-1
Chapter 10 Storage............................................................................................... 10-1
(Electrosurgical Instruments)
Chapter 11 Treatment with Electrosurgical Instruments .................................... 11-1
[Note] As for the table of contents details of “Cleaning, Disinfection and Storage” and
“Electrosurgical Instruments”, refer to each operation manual.
Contents
7

Preface
This manual describes how to use endoscope EN-580T.
For how to use the peripherals used in combination with this product, refer to the
respective operation manuals.
Conventions Used in This Manual
This manual uses the following conventions for easier understanding.
General conventions
Convention Description
Indicates a potential danger that may cause harm to people.
WARNING Explains dangerous situations that may cause death or serious
injury if not avoided.
CAUTION Explains situations that may cause injury if not avoided.
CAUTION Explains situations that may cause damage to equipment
if not avoided.
(1), (2), (3), ...
Indicates consecutive numbers in operating procedures for the
order in which successive steps in the procedure should be
taken.
[Note] Indicates a comment or supplementary information.
Indicates a reference.
Preface
8

Chapter 1 Safety
This chapter summarizes the information necessary for safe use of this
product.
1-1

Chapter 1 Safety
1. Precautions in Using Endoscope
1) Applicable processor and light source
This product is used in combination with processor VP-4450HD and light source XL-4450.
2) Preparation and inspection before use
Prior to using this product, prepare a spare one to avoid unexpected accidents such as
equipment failure. If a replacement is not available, you may not be able to continue
endoscopic procedures.
Have this product inspected by medical specialists who have received proper training in
endoscopic procedures before use according to the procedures provided in this manual, to
avoid unexpected accidents, and take full advantage of the equipment’s capabilities.
If the inspection result shows any abnormality, do not use the same equipment.
3) Combination of equipment
The endoscope may be used in combination with peripherals. To avoid an electric shock
accident, use only the peripherals that are described in this operation manual.
Read also the attached document and operation manual of the peripherals used in
combination with this product.
4) Prohibition of reuse
The Over-tube, balloon, setting tool ST-05B and forceps valve are intended for single
patient use. To prevent infection, do not reuse them.
5) Expiration date for use
Do not use Over-tube, balloon, setting tool ST-05B or forceps valve after its expiration date
has passed.
6) Preparation before use
Use diathermic treatment equipment or an endoscope which can be used with diathermic
treatment equipment to provide proper emergency treatment, in cases of bleeding.
Chapter 1 Safety
1-2