Fujifilm ED-530XT User Manual
Endoscope
ED-530XT
US
OPERATION MANUAL
(
Preparation and Operation
Thank you for purchasing our product. Read this manual carefully before use to avoid unex-
pected accid ents and to take full adv anta ge o f the p ro du c t’s capabilities.
Please refer to separate operation manual (Cleaning, Disinfection and Storage) for detailed
recommendations on the cleaning, high-level disinfection and sterilization of FUJIFILM
endoscopes. Also, refer to the third operation manual containing recommendations on
electrosurgical instruments.
)
Important Sa fe t y Informat i on
Important Safe ty Infor mation
For the USA Market - CAUT ION:
Federal law restricts this device to sale by or on the order of a physician.
1. Intended Use
This product is a medical Endoscope for the duodenum and upper G.I. tract. It is intended
for observation, diagnosis, and endoscopic treatment of the esophagus, stomach and
duodenum. Never use this product for any other purposes.
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 Ch apter 1 “Saf ety.”
Safety precautions associated with individual operations or procedures are provided
separately, in dicated “
WARNING” or “ CAUTION.”
3. Warning
Items that must be observed for safety when performing endoscopy or electrosurgery
are identified by “
reading and understa nding the warning information care fully.
Improper o perat io ns th a t will da m a ge th e equ i pm en t onl y are i de nt if i ed by “ C AU TION.”
4. Ab out Clinical Procedures
This manual assumes that the product will be used by medical specialists who have
received proper training in endoscopic procedures. It does not provide information
about clinical procedures. Regarding clinical procedures, use proper clinical judgment.
WARNING” or “ CAUTION.” Perform procedu res correctly by
WARNING
Improper use or operation of the equipment may injure
patients, physicians, or people in the v icinity.
Read and understand this manual carefull y before
operating the equipment.
2
5. When U sing the Endoscope f or the First T ime
This product has not been sterilized. When using it f or the first tim e, use th e level of high -
level disinfecti on or sterilization s uitable to the applicat ion, in accordance w ith Chapter 7
“Cleaning,” Chapter 8 “High-Level Disinfection,” and Chapter 9 “Gas Sterilization.”
6. Single Use Only
Forceps valve are intended for single use. To pr event infection, do not reuse them.
7. Treatment with Electrosurg ical 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 therapeutic
accessories.
Important Sa fe t y Informat i on
8. If Any Abnorma lity Occurs D uring the Clinical Procedu re
If any abnormality occurs with the equipment, refer to “Troubleshooting.” Especially,
continued use of th e equ i pment with abn ormal images can c au s e burn and injury by h eat
generation from the distal of the Endoscope.
9. Loss of Function
During an exami n ation, if th e 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 treatment tool from the endoscope, and then reset the proces sor
and light so ur ce.
If an appropriate image do es not appear even after resetting the processo r and light
source, turn them off, str a ighte n the bending po r tion to unlock, relea se 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 l i ght sourc e, 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 b utto n.
3
Important Sa fe t y Informat i on
Operation Manuals a nd C ont e nt s
Operation Manuals and Contents
(Preparation and Operation)
Important Safety Inf ormati on...................................................................................... 2
Preface........................................................................................................................ 6
Conventions Used in This Manual............................................................................. 6
Chapter 1 Safety .................................................................................................. 1-1
Chapter 2 Composition of Set and System Configuration ................................... 2-1
2.1 Composition of Set...................................................................... 2-2
2.2 System Configu ration.................................................................. 2-4
Chapter 3 Names and Functions of Parts ............................................................ 3-1
Chapter 4 Control Portion.................................................................................... 4- 1
4.1 How to Operate the Bending Mechanism.................................... 4-2
4.2 Valve Control Buttons and Forceps Inlet..................................... 4-4
4.3 Remote Operating Switches for Images and Re cordin g............... 4-5
4.4 Forceps Valve .............................................................................. 4-6
4.5 How to Operate Forceps Eleva tor Mech anism ............................ 4-7
Chapter 5 Preparation for Use of the Endoscope................................................. 5-1
5.1 Preparing Equ ipm ent ................................................................... 5-2
5.2 Preparing Forceps Valve.............................................................. 5- 4
5.3 Connecting the End osc ope ......................................................... 5-6
5.4 Inspection o f E nd o scop e ............................................................ 5-8
5.5 Inspection of For ce ps ............................................................... 5-13
Chapt er 6 Method of Use .................................................................................... 6-1
6.1 Preparation .................................................................................. 6-2
6.2 Insertion and Ob ser vatio n........................................................... 6-3
6.3 Biopsy ......................................................................................... 6-7
6.4 ERCP ......................................................................................... 6-9
6.5 Pulling Out the Endoscope........................................................ 6-11
Appendix................................................................................................... Appendix-1
Main Specifications............................................................... Appendix-2
Troubleshooting ................................................................... Appendix-6
After-Sal es Serv ice................................................................ Appendix-9
Index ....................................................................................Appendix-10
Service Centers .................................................................... Appendi x - 1 2
4
Important Sa fe t y Informat i on
Operation Manuals a nd C ont e nt s
(Cleaning, Disinfection and Storage)
Chapter 7 Cleaning .............................................................................................. 7-1
Chapter 8 High-L evel Di sin fe ctio n ...................................................................... 8-1
Chapter 9 ETO G as S t er il i za t io n........................................................................... 9-1
Chapter 10 Cleaning and High-Level Disinfection/Sterilization
of Endoscopic Accessories ............................................................... 10-1
Chapter 11 Storage .............................................................................................. 11 - 1
(Electrosurgical Instruments)
Chapter 12 Treatment with Electrosurgical Instrume n ts...................................... 12-1
[Note] T hese instructions are descr ibed in separa te ope ration manuals.
[Note]
[Note]
5
Important Sa fe t y Informat i on
Preface
Preface
This manual describes how to use ED-530XT.
Conventions Used in This Manual
This manual uses the following conventions for easier understanding.
General conventions
Convention Description
WARNING
CAUTION
CAUTION
(1), (2), (3),
[Note] Indicates a comment or supplementary information.
Indicates a potential danger that may cause harm to people.
Explains dangerous situations that may cause death or serious
injury if not avoided.
Explains situations that may cause injury if not avoided.
Explains situatio ns that may ca use d a mage to eq uip ment i f no t
avoided.
Indicates consecutive numbers in operating procedures for the
...
order in which successive steps in the procedure should be
taken.
Indicates a reference.
6
Chapter 1 Safety
This chapter summarizes the information necessary for safe use of Endoscope.
Chapter 1 Safety
1-1
Chapter 1 Safety
Chapter 1 Safety
1. Precautions in U sing Endoscope
1) 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.
Make sure to insp ect the equipment before use ac cor ding to the procedures pr ovided in this
manual, to avoid unexpected accidents, and take full advantage of the equipment’s capabilities.
If the inspection r e su lt shows any abnormality, do not use the same equipment.
2) Combination of equipment
The Endoscope may be used in combination with peripherals. To avoid an electric shock
accident, do not use a ny periph erals than the ones specified in this operation manual.
3) Abnormality in use
If any abnormality is noticed during use, carry out safety checks and discontinue use
immediately.
4) Maintenance
The equipment will wear out and degrade af ter repeated use for a long period. Especi ally, the
portions such as rubber and resin deteriorate also by chemicals to be used a change with the
passage of time. Have it checked by speciali sts once every six m onth s or once every 100 cases.
Also have it checked if there is anything wrong with the equipment.
Do not disassemble or modify the equipment.
5) Operation of Endoscope
Endoscope is a precision instrument. Unnatural force or impact on the insertion portion,
flexible portion, or distal end may injure the inside of the patient as well as dama ge the in strument. If you encounter any resistance, insert it slowly. Do not force it in. Do not insert or bend
the Endoscope without securing the view on the monit o r.
1-2
6) Handling of Endoscope
When holding Endoscope, hold it by the control portion. Handling it up by the insertion
portion or LG flexible portion is difficult to hold and may exert an un natural force, resulting in
instrument f ailure.
Pull on rubber gloves when handling an Endoscope to prevent infection and static charges.
7) Temperature at dis t al end
When the Endoscope projects light at high brightness for an extended time, the temperature
may exceed 41°C at the distal end. Turn off the lamp when you hang the Endoscope on the cart
hanger.
8) Electromagnetic interference
This equipment has been tested and found to comply with the limits for medical devices
defined in EN 60601-1-2:2001. These limits are designed to provide reasonable protection
against harmful interference in a typical m edical installation. However, it is possible that it may
cause harmful interfe rence to ot her devices in the vicin ity, if it is installed and us ed in accordance
with the instructions. Also, there is no guarantee that interference will not occur in a particular
installati on. Theref ore, if this equi pm ent does cau se h arm ful inte rfe rence to ot her d evices , w hi ch
can be determined by turnin g t he equi pment off and on, the user is encouraged to try to correct
the interference by one or more of the following m easu res:
Chapter 1 Safety
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 w aves.
In this case, turn off the device emitting the electromagnetic waves or move the device away
from this equipment.
2. Cleaning and High-L evel Disinfection/Sterilization
This product has not been sterilized. When using it for the fir st time, p erform high-l evel
disinfection or sterilization suitable for the application.
When reusing this product, clean and then, disinfect or sterilize it (Cleaning, Disinfection and
Storage). Inadequate cleaning, high-level disinfection or sterilization may result in infection.
Cleaning, high- l ev el disin fection or sterilization the insertion portion and channels especially
carefully.
Wear protective gea r during chemical cleanin g and high-lev el disinf ection to protect your skin
and to prevent infection.
1-3
Chapter 1 Safety
When using th is pro duct fo r a pat ient with Cr eutzfeld t-Jako b dise ase (esp eciall y variant
Creutzfeldt-Jakob disease), use it exclusively for a patient with the same disease, or properly
discard this product after use. Since the cleaning, high-level disinfection and steriliza tion
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 treatmen t of Creutzf eldt-Jakob disease, refer to th e guideline s for it available.
3. Disposal
This product has heavy metal parts. When disposing of this product, comply with local laws
and regulations in your area. Determine w h ether or not th e produ ct i s to be tr eat ed as in fe ctiv e
waste, depending on the usage state.
4. “ Warning” and “ Caution” Messages Appearing in Individual Chapters
Chapter 5 Preparation for Use of the En dos cope
The use of abnormal equipment will cause wrong diagnosis or injury. Do not use the abnormal
equipment.
5.3 Connecting the Endoscope
Touching the LG connector with hands immediately after use of the Endoscope may cause to
burn. Do not touch the LG connector tip until it will be cooled down (approximately 5 minutes).
Endoscope may be adhered to mucous membrane, resulting in damage to the mucous mem-
brane. Set a suction pressure at 53kPa or less.
5.4.5 Inspecting t he Objectiv e Le ns
Viewing the light of light guide directly may damage your eyes. Switch off the light before
inspecting the lens.
Chapter 6 Method of Use
Do not supply an excessive amount of air or gas during electrosurgery. It could ca use an
embolism.
6.2 Insertion and Obse rv at i on
Energy of illumination may burn. Do not allow the distal end to touch the same part for 5
minutes or more.
1-4
6.3 Biopsy
It may cause holing or bleeding. Do not press them the digestive tract wall with undue force.
6.4 ERCP
Pressing the cannulation tube strongly against the digestive tract wall may damage it. Do not
press it against digestive tract wall with undue force.
Chapter 7 Cleaning
7.4.5 Disconnecting Endoscope f rom Processor
Do not touch the tip of LG (Light Guide) connector until it has cooled down (approximately 5
minutes after turnin g o ff the po wer of the light source ) . Touching the LG co nne c to r tip with
one’s hand immediately after use of this product may cause a burn.
7.4.6 Detaching Endoscope Components (A/W button, suction button, forceps valve, etc.)
The forceps valve is a single patient use item. DO NOT reuse it as continued reuse presents an
infection risk.
7.5 Manual Cleaning (cleaning in basin)
Carefully inspect all cleaning brushes prior to use and check the brushes integrity after use to
ensure that the accessories are not damaged and no brush or accessory fragment remains
inside the channel. Retained brush/accessory fragments could be a potential source of infection and/or ca use patient injury.
Before using any cleaning brush for a valve cylinder or channel port, remove any debris from
the bristles on the brush. This will avoid reintroduction of patient mate r ial into the channels/
lumens.
Chapter 1 Safety
7.5.9 Rins in g En dosco pe
After cleaning, thoroughly remove all detergent residue as per the provided instructions that
follow to prevent the potential for inadvertent dilution or adulteration of the liquid chemical
germicide used in subsequent steps.
Thoroughly rinse any remaining detergent with potable water after the cleaning process.
Chapter 8 High-Level Disinfection
8.4 Rin sing En doscope
After disinfection, thoroughly remove all high-level disinfectant solution residue as per the
provided rinsing instructions that follow to prevent patient injury from contact with the residual high-level disinfectant solution.
8.5 Cleaning and/or Disinfection Using an Automated Endoscope Reprocessor (AER)
Some legally marketed autom ated endoscope reprocessors (AERs) may be able to clean and/or
disinfect Fujinon/ Fujifi lm endoscopes. How ever , end-users sh ould check w ith each AER manufacturer to confirm they have validation data to support their reprocessing claims for Fujinon/
Fujifilm endoscopes and re movable endosc ope componen ts, such as valve mechanism s . Inadequate device-specific instructions and/or non-validated AER recommendations could result
in unsuccessful cleaning and/or disinfection which may increase risks to patient safety.
1-5
Chapter 1 Safety
Chapter 9 ETO Gas Sterilization
Chapter 10 Cleaning and High-Level Disinfection/Sterilization of Endoscopic Accessories
Chapter 11 St orag e
Ensure that all ins trument su rfaces are dry bef ore attempting ETO gas s terilization. Failure to
do so can result in inadequate sterilization.
Aeration p ro ce d ures must b e p e r for med immediat ely after E T O gas s teril iza ti on in o rd er to
remove potentially harmful gas residuals from contacting patients. No or incomplete aeration
can potentially harm patients.
10.4.1 High-Level Disinfection of Forceps Valve
The forceps valv e m us t be completely im m ers ed in a hig h - lev el dis in f ectan t sol uti on. Rem o ve
air bubbles completely. If any air bubbles remain, effective disinfection cannot be achieved and
an inadequately high-level disinfect e d forceps valve may be an infection risk.
Do not store this product in a carrying case. Storage of this product in a carrying case and
subsequent clinical use may cause infection.
Chapter 12 Using Electrosurgical Instruments
12.1 High-frequency cauterization
Do not use an electrosurgical unit when supplyi ng f lamm able gas. There is a risk of ignition. If
necessary, use nonfl am mable gas such as carbon dioxide. Do not use excessive nonflammable
gas.
Wear electrically insulating gloves when using an electrosurgical unit or accessory. If not
worn, th er e is a ri sk of the rm al i nju ry or electri c shock.
Be sure electrically conductive parts within the patient v icinity such as m etal parts of a bed are
not in direct contact with a patient 's body. There is a risk of th ermal inju ry.
Always keep patients with a pacemaker away from electrosurgical instruments. The operation
of the pacemaker m ay malfunction by the electrosurg ical instruments.
Do not energize the elect rosurgical instruments when the electrically active portion of highfrequency surgical instrument and the metal part at the distal end of endoscope are in contact
with each other. Thermal injury or scope damage may occur.
Connect the electrosurgical instruments and electrosurgical generators in accordance with
each operating manual. Incorrect connection may cause electric shock and/or burns.
Operate th e i nstr uments within sp ec ifie d o utp ut ra nge a s p e r the d ev ic e’s operatin g in st ructions. Leak ag e current may cause thermal injury.
1-6
Chapter 2 Composition of Set and System Configuration
Chapter 2 C omposition of Set and System
Configuration
This chapter describes the composition of Endoscope set and system
configuration.
2.1 Composition of Set...................................................... 2-2
2.2 System Config u ration.................................................. 2-4
2-1
Chapter 2 Composition of Set and System Configuration
Chapter 2 Composition of Set and System Configuration
2.1 Composition of Set
The Endoscope set is provided in a carrying case. The set consists of the following items.
[Note] Figures in par ent heses ind ica te quanti ties.
Carrying Case (1)
Forceps V al ve
FOV-DV7 (10)
Protective Cap
Suction (1)
Protective Cap
A/W Ventilation Connector (1)
S Connector Cap
CAP-E (1)
Cleaning Brush
WB4321FW2 (1)
Cleaning Brush (for Valve)
WB11002FW2 (1)
2-2
Chapter 2 Composition of Set and System Configuration
Suction Button
SB-500 (1)
Operation Manual
Preparation and Operation (1)
Cleaning, Disinfection and Storage (1)
Electrosurgical Instruments (1)
Ventilation Adapter
AD-7 (1)
Syringe (1)
Air/Water Button
AW-500 (1)
Endoscope (1)
T ank Receiving Cap (1)
Tube for Air/Water Supply Channel (1)
Valve Adapter
CA-503S/A ( 1)
Forceps Inlet Cleaning Adapter (with a Cap)
CA-503B/C (1)
Cleaning Adapter Kit
CA-503/A (1)
Valve Set (1)
Tube for Suction Channel (1)
2-3
Chapter 2 Composition of Set and System Configuration
2.2 Sy stem Configura tion
You may use the ED-530XT with various peripherals attached to it. The se p eri pher als ar e
available separately. Extension makes the following possibl e.
Endoscopic treatment
Ultrasonography through forceps channel
Recording of V ideo images
Printer output
Endoscope
ED-530XT
Sonoprobe System
Light Source
XL-4400
Processor
VP-4400
Water T an k
WT-2
2-4
Data Keyboard
DK-4400E
Foot Switch
FS1
Cart
Chapter 2 Composition of Set and System Configuration
[Note] For details on the connections of peripherals other than those listed here, please
contact your local dealer.
LCD Monitor
CDL1576A
CDL1909A
Video Printer
UP-51MD-120V, 230V-(SONY)
UP-51MDU-120V-(SONY)
UP-21MD (SONY)
UP-55MD (SONY)
CP900E-230V-(MITSUBISHI)
CP900UM-120V-(MITSUBISHI)
DVD Recorder
DSR-20 MD (SONY)
LQ-MD800 (Panasonic)
Electrosurgical Instrument
ICC 200 (ERBE)
2-5
Chapter 2 Composition of Set and System Configuration
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2-6
Chapter 3 Names a nd F u nc t i ons of Pa rt s
Chapter 3 Names and Func tions of Parts
This chapter describes the names and functions of Endoscope parts as well as
the composition of the main bod y .
3-1
Chapter 3 Names a nd F u nc t i ons of Pa rt s
Chapter 3 Names and Functions of Parts
The main b ody of th e ED-530XT consi s ts of the following part s .
Control portion
Provides a grip for holding the Endo sco pe.
Also contains parts for operating the E ndoscop e.
Feed water connector
Connects to th e water tank.
LG flexible portion
Contains light guide, a ir/water supp ly tube,
suction tube and cables.
Ve ntilatio n connector
Connects to the air leak tester or ventilation adapter.
3-2
Enlarged view of distal end
Insertion portion
This portion is inserted into body cavities and contains the
distal end, ben din g port ion and fl ex ible porti on.
Flexible porti on
Connects bending portion and control portion.
The Endo sc op e can b e ins ert ed in to the body cavity up to this p o r tio n.
Distal end
Contains objective len s, air/water n o zzles, forceps channel,
etc. Air/wat er supply an d s u ction are control l ed by buttons
on the control portion.
Chapter 3 Names a nd F u nc t i ons of Pa rt s
ED-530XT
Waterproof cap
Prevent w ate r from remaining on electri c con tac t.
EVE connector
This connector connects to the EVE connector
socket on the proc essor.
Bending portion
Bend this po rtion with the knob s
on the control portion.
LG connector
This connector connects to the scope
socket o n the li ght source.
Suction connector
Accepts tube from suction uni t.
S connector
Accepts S-cord when using electrosurgical
instrumen t (e lectric cau ter y ).
3-3
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