Olympus EVIS EXERA II User manual

Refer to the endoscope’s companion manual, the “OLYMPUS TJF TYPE Q180V
REPROCESSING MANUAL”, for reprocessing information.
USA: CAUTION: Federal law restricts this device to sale by or on the order of a
physician.
INSTRUCTIONS
EVIS EXERA II DUODENOVIDEOSCOPE
OLYMPUS TJF TYPE Q180V

Contents
i
EVIS EXERA II TJF TYPE Q180V 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 ............................................................................ 4
Reprocessing before the first use/reprocessing and storage after use .... 4
Spare equipment ...................................................................................... 4
Maintenance management........................................................................ 5
Prohibition of improper repair and modification ........................................ 5
Signal words ............................................................................................. 5
Warnings and cautions.............................................................................. 6
Examples of inappropriate handling ......................................................... 9
Chapter 1 Checking the Package Contents............................ 10
Chapter 2 Instrument Nomenclature and Specifications ...... 12
2.1 Nomenclature.................................................................................. 12
2.2 Endoscope functions....................................................................... 14
2.3 Specifications.................................................................................. 16
2.4 Attaching the chain for water-resistant cap (MAJ-1119) ................. 19
Chapter 3 Preparation and Inspection .................................... 22
3.1 Preparation of the equipment.......................................................... 23
3.2 Inspection of the endoscope ........................................................... 24
3.3 Preparation and inspection of accessories ..................................... 28
3.4 Attaching accessories to the endoscope ........................................ 32
3.5 Inspection and connection of ancillary equipment .......................... 34
3.6 Inspection of the endoscopic system .............................................. 37
Chapter 4 Operation ................................................................. 41
4.1 Insertion .......................................................................................... 44
4.2 Using EndoTherapy accessories .................................................... 49
4.3 Withdrawal of the endoscope.......................................................... 62
4.4 Transportation of the endoscope .................................................... 63

Contents
ii EVIS EXERA II TJF TYPE Q180V OPERATION MANUAL
Chapter 5 Troubleshooting ...................................................... 64
5.1 Troubleshooting guide .................................................................... 64
5.2 Withdrawal of the endoscope with an irregularity............................ 68
5.3 Returning the endoscope for repair................................................. 70
Chapter 6 Inspection Schedule Related to Forceps Elevator 71
6.1 Inspection after each patient procedure.......................................... 71
6.2 Inspection before each patient procedure....................................... 72
6.3 Annual inspection............................................................................ 72
Appendix........................................................................................ 73
System chart ............................................................................................ 73
EMC information........................................................................................ 84

Symbols
1
EVIS EXERA II TJF TYPE Q180V OPERATION MANUAL
Symbols
The meaning(s) of the symbol(s) shown on the component packaging, the back
cover of the instruction manual, and/or the instrument are as follows:
Refer to instructions.
Caution
Endoscope
TYPE BF applied part
Single use only
Lot number
Manufacturer
Authorized representative in the European Community
Serial number

2
Important Information — Please Read Before Use
EVIS EXERA II TJF TYPE Q180V 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, monitor, EndoTherapy
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. Select
the endoscope to be used according to the objective of the intended procedure
based on the full understanding of the endoscope’s specifications and
functionality as described in this instruction manual.
Applicability of endoscopy and endoscopic treatment
If there are official standards on the applicability of endoscopy and endoscopic
treatment that are defined by the hospital’s administrations or other official
institutions, such as academic societies on endoscopy, follow those standards.
Before starting endoscopy and endoscopic treatment, thoroughly evaluate its
properties, purposes, effects, and possible risks (their nature, 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 II TJF TYPE Q180V 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 for all equipment that 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” with your endoscope model listed
on the cover. 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,
contact Olympus.
Terms used in this manual
User qualifications
If there are official standards for user qualifications to perform endoscopy and
endoscopic treatment that are defined by the hospital’s medical administrators or
other official institutions, such as academic societies on endoscopy, follow those
standards. If there are no official qualification standards, the operator of this
instrument must be a physician approved by the medical safety manager of the
hospital or person in charge of the department (department of internal medicine,
etc.).
The physician should be capable of safely performing the planned endoscopy
and endoscopic treatment following guidelines set by the academic societies on
endoscopy, etc., and considering the difficulty of endoscopy and endoscopic
treatment. This manual does not explain or discuss endoscopic procedures.
NBI (Narrow Band Imaging) observation mode:
This is an observation mode using narrowband light.
Normal light observation mode (or WLI (White Light Imaging) observation
mode):
This is an observation mode using standard white light illumination.

4
Important Information — Please Read Before Use
EVIS EXERA II TJF TYPE Q180V OPERATION MANUAL
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 the EMC standard for medical electrical
equipment, edition 2 (IEC 60601-1-2: 2001). However, when connected with an
instrument that complies with the EMC standard for medical electrical
equipment, edition 1 (IEC 60601-1-2: 1993), the whole system complies with
edition 1.
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 “REPROCESSING MANUAL”
with your endoscope model listed on the cover.
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 pose an infection control risk, cause
equipment damage, or reduce performance.
Spare equipment
Be sure to prepare another endoscope to avoid interruption of the examination
due to equipment failure or malfunction.

Important Information — Please Read Before Use
5
EVIS EXERA II TJF TYPE Q180V OPERATION MANUAL
Maintenance management
The probability of failure of the endoscope and ancillary equipment increases as
the number of procedures performed and/or the total operating hours increase.
In addition to the inspection before each procedure, the person in charge of
medical equipment maintenance in each hospital should inspect the items
specified in this manual periodically. An endoscope with an observed irregularity
should not be used, but should be inspected by following Section 5.1,
“Troubleshooting guide” on page 64. If the irregularity is still observed after
inspection, contact Olympus.
Maintenance of the forceps elevator has to be performed according to Chapter 6,
“Inspection Schedule Related to Forceps Elevator” in the manual.
Prohibition of improper 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 may result.
Equipment that has been disassembled, repaired, altered, changed, or modified
by persons other than Olympus’ own authorized service personnel is excluded
from Olympus’ limited warranty and is not warranted by Olympus in any manner.
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.

6
Important Information — Please Read Before Use
EVIS EXERA II TJF TYPE Q180V 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.
• For more information on combining the endoscope with a
particular electrosurgical generator, refer to “System chart”
on page 73. Do not use an electrosurgical generator that
does not comply with medical electrical equipment (EN
60601-1:2013). It could cause patient burns.
• After using this instrument, reprocess and store it according
to the instructions given in the endoscope’s companion
“REPROCESSING MANUAL” with your endoscope model
listed on the cover. Using improperly or incompletely
reprocessed or stored instruments may cause patient
cross-contamination and/or infection.
• Before endoscopy, remove any metallic objects (watch,
glasses, necklace, etc.) from the patient. Performing
high-frequency cauterization treatment while the patient is
wearing metallic objects may cause burns on the patient in
areas around the metallic objects.
• Do not strike, hit, or drop the endoscope’s distal end,
insertion tube, bending section, control section, universal
cord, or endoscope connector. Also, do not bend, pull, or
twist the endoscope’s distal end, insertion tube, bending
section, control section, universal cord, or endoscope
connector 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 may result. It may
also become impossible to straighten the bending section
during an examination.
• Never insert or withdraw the endoscope’s insertion section
while the bending section is locked in position. Patient injury,
bleeding, and/or perforation may result.