Olympus EVIS EXERA TJF-160VR User manual

Refer to the endoscope’s companion manual, the “OLYMPUS TJF TYPE 160VR
REPROCESSING MANUAL” for reprocessing information.
INSTRUCTIONS
EVIS EXERA DUODENOVIDEOSCOPE
OLYMPUS TJF TYPE 160VR

Contents
i
EVIS EXERA TJF TYPE 160VR OPERATION MANUAL
Contents
Symbols......................................................................................... 1
Important Information — Please Read Before Use.................... 2
Intended use ............................................................................................ 2
Applicability of endoscopy and endoscopic treatment ............................. 2
Instruction manual..................................................................................... 3
User qualifications .................................................................................... 3
Instrument compatibility ........................................................................... 3
Reprocessing before the first use/reprocessing and storage after use..... 4
Spare equipment ...................................................................................... 4
Repair and modification ........................................................................... 4
Signal words ............................................................................................. 4
Warnings and cautions.............................................................................. 5
Examples of inappropriate handling ......................................................... 7
Chapter 1 Checking the Package Contents............................ 8
Chapter 2 Instrument Nomenclature and Specifications ...... 10
2.1 Nomenclature.................................................................................. 10
2.2 Endoscope functions....................................................................... 12
2.3 Specifications.................................................................................. 14
Chapter 3 Preparation and Inspection .................................... 17
3.1 Preparation of the equipment.......................................................... 18
3.2 Inspection of the endoscope ........................................................... 19
3.3 Preparation and inspection of accessories ..................................... 23
3.4 Attaching accessories to the endoscope ........................................ 28
3.5 Inspection and connection of ancillary equipment .......................... 37
3.6 Inspection of the endoscopic system .............................................. 39
Chapter 4 Operation ................................................................. 44
4.1 Insertion .......................................................................................... 46
4.2 Using endo-therapy accessories..................................................... 52
4.3 Withdrawal of the endoscope.......................................................... 61
4.4 Transportation of the endoscope .................................................... 62

Contents
ii EVIS EXERA TJF TYPE 160VR OPERATION MANUAL
Chapter 5 Troubleshooting ...................................................... 63
5.1 Troubleshooting guide .................................................................... 63
5.2 Withdrawal of the endoscope with an abnormality.......................... 67
5.3 Returning the endoscope for repair................................................. 69
Appendix........................................................................................ 71
System chart ............................................................................................ 71
EMC information........................................................................................ 80

Symbols
1
EVIS EXERA TJF TYPE 160VR OPERATION MANUAL
Symbols
The meaning(s) of the symbol(s) shown on the package with the components,
the back cover of this instruction manual and/or this instrument are as follows:
Refer to instructions.
Endoscope
TYPE BF applied part
Manufacturer
Authorized representative in the European Community

2
Important Information — Please Read Before Use
EVIS EXERA TJF TYPE 160VR OPERATION MANUAL
Important Information — Please Read
Before Use
Intended use
This instrument has been designed to be used with an Olympus video system
center, light source, documentation equipment, video monitor, endo-therapy
accessories (such as a biopsy forceps) and other ancillary equipment for
endoscopy and endoscopic surgery within the duodenum.
Do not use this instrument for any purpose other than its intended use.
Applicability of endoscopy and endoscopic treatment
If there is an official standard on the applicability of endoscopy and endoscopic
treatment that is defined by the hospital’s administration or other official
institutions such as academic societies on endoscopy, follow that standard.
Before starting endoscopy and endoscopic treatment, thoroughly evaluate its
properties, purposes, effects, and possible risk (their natures, extent and
probability). Perform endoscopy and endoscopic treatment only when its
potential benefits are greater than its risks.
Fully explain to the patient the potential benefits and risks of the endoscopy and
endoscopic treatment as well as any examination/treatment methods that can be
performed in its place, and perform the endoscopy and endoscopic treatment
only after obtaining the consent of the patient.
Even after starting the endoscopy and endoscopic treatment, continue to
evaluate the potential benefits and risks, and immediately stop the
endoscopy/treatment and take proper measures if the risks to the patient
become greater than the potential benefits.

Important Information — Please Read Before Use
3
EVIS EXERA TJF TYPE 160VR OPERATION MANUAL
Instruction manual
This instruction manual contains essential information on using this instrument
safely and effectively. Before use, thoroughly review this manual and the
manuals of all equipment which will be used during the procedure and use the
equipment as instructed.
Note that the complete instruction manual set for this endoscope consists of this
manual and the “REPROCESSING MANUAL” whose cover lists the model of
your endoscope. It also accompanied the endoscope at shipment.
Keep this and all related instruction manuals in a safe, accessible location.
If you have any questions or comments about any information in this manual,
please contact Olympus.
User qualifications
The operator of this instrument must be a physician or medical personnel under
the supervision of a physician and must have received sufficient training in
clinical endoscopic technique. This manual, therefore, does not explain or
discuss clinical endoscopic procedures. For details on clinical endoscopic
procedures, the physician and operator are requested to form judgments from
their viewpoints as specialists.
Instrument compatibility
Refer to the “System chart” in the Appendix to confirm that this instrument is
compatible with the ancillary equipment being used. Using incompatible
equipment can result in patient or operator injury and/or equipment damage.
This instrument complies with EMC standard for medical electrical equipment;
edition 2 (IEC 60601-1-2: 2001). However, when connected with an instrument
that complies with EMC standard for medical electrical equipment; edition 1
(IEC 60601-1-2: 1993), the whole system complies with edition 1.

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Important Information — Please Read Before Use
EVIS EXERA TJF TYPE 160VR OPERATION MANUAL
Reprocessing before the first use/reprocessing and
storage after use
This instrument was not cleaned, disinfected or sterilized before shipment.
Before using this instrument for the first time, reprocess it according to the
instructions given in the endoscope’s companion manual, the “REPROCESSING
MANUAL” whose cover lists the model of your endoscope. After using this
instrument, reprocess and store it according to the instructions given in the
endoscope’s companion reprocessing manual. Improper and/or incomplete
reprocessing or storage can present an infection-control risk, cause equipment
damage or reduce performance.
Spare equipment
Be sure to prepare another endoscope to avoid that the examination will be
interrupted due to equipment failure or malfunction.
Repair and modification
This instrument does not contain any user-serviceable parts. Do not
disassemble, modify or attempt to repair it; patient or operator injury and/or
equipment damage can result. This instrument is to be repaired by Olympus
technicians only.
Signal words
The following signal words are used throughout this manual:
Indicates a potentially hazardous situation which, if not
avoided, could result in death or serious injury.
Indicates a potentially hazardous situation which, if not
avoided, may result in minor or moderate injury. It may also
be used to alert against unsafe practices or potential
equipment damage.
Indicates additional helpful information.

Important Information — Please Read Before Use
5
EVIS EXERA TJF TYPE 160VR OPERATION MANUAL
Warnings and cautions
Follow the warnings and cautions given below when handling this instrument.
This information is to be supplemented by the warnings and cautions given in
each chapter.
• After using this instrument, reprocess and store it according
to the instructions given in the endoscope’s companion
reprocessing manual. Using improperly or incompletely
reprocessed or stored instruments may cause patient
cross-contamination and/or infection.
• Do not strike, bend, hit, pull, twist, or drop the endoscope’s
distal end, insertion tube, bending section, control section,
universal cord, or endoscope connector of the endoscope
with excessive force. The endoscope may be damaged and
could cause patient injury, burns, bleeding and/or
perforations. It could also cause parts of the endoscope to fall
off inside the patient.
• Never perform angulation control forcibly or abruptly. Never
forcefully pull, twist or rotate the angulated bending section.
Patient injury, bleeding and/or perforation can result. It may
also become impossible to straighten the bending section
during an examination.
• Never insert or withdraw the endoscope’s insertion tube while
the bending section is locked in position. Patient injury can
result.
• Do not touch the light guide of the endoscope connector
immediately after removing it from the light source because it
is extremely hot. Operator or patient burns can result.
• Do not twist the insertion tube within a narrow tube. This
could cause the distal cover to come off.
• Never operate the bending section, feed air or perform
suction, insert or withdraw the endoscope’s insertion tube,
without viewing the endoscopic image. Never use
endo-therapy accessories without viewing the endoscopic
image. Patient injury can result.
• Never operate the bending section, feed air or perform
suction, insert or withdraw the endoscope’s insertion tube
while the image is frozen. Never use endo-therapy
accessories while the image is frozen. Patient injury, can
result.

6
Important Information — Please Read Before Use
EVIS EXERA TJF TYPE 160VR OPERATION MANUAL
• Never insert or withdraw the endoscope’s insertion tube with
excessive force. Otherwise, patient injury could result.
• Do not pull the universal cord during an examination. The
endoscope connector will be pulled out from the output
socket of the light source and the endoscopic image will not
be visible.
• Do not coil the insertion tube or universal cord into a diameter
of less than 12 cm. Equipment damage can result.
• Do not touch the electrical contacts inside the electrical
connector. CCD damage may result.
• Do not apply shock to the distal end of the insertion tube,
particularly the objective lens surface at the distal end.
Visual abnormalities may result.
• Do not twist or bend the bending section with your hands.
Equipment damage may result.
• Do not squeeze the bending section forcefully. The covering
of the bending section may stretch or break and cause water
leaks.
• Turn the video system center OFF before connecting or
disconnecting the videoscope cable from the electrical
connector on the endoscope. Turn the switch ON or OFF
only when the videoscope cable is connected to both the
video system center and electrical connector on the
endoscope. Failure to do so can result in equipment damage,
including destruction of the CCD.
• The endoscope’s remote switches cannot be removed from
the control section. Pressing, pulling or twisting them with
excessive force can break the switches and/or may cause
water leaks.
• If remote switch 1 does not return to the OFF position after
being pressed strongly from the side, gently pull the switch
upwards to return it to the OFF position.
• Do not hit or bend the electrical contacts on the endoscope
connector. The connection to the light source may be
impaired and faulty contact can result.
• Do not attempt to bend the endoscope’s insertion tube with
excessive force. Otherwise, the insertion tube may be
damaged.