Olympus EVIS EXERA II User manual

Refer to the endoscope’s companion manual, the “REPROCESSING MANUAL” whose
cover lists the model of your endoscope, for reprocessing information.
USA: CAUTION: Federal law restricts this device to sale by or on the order of a
physician.
INSTRUCTIONS
EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE
OLYMPUS GIF TYPE N180
OLYMPUS GIF TYPE Q180
OLYMPUS GIF TYPE H180
EVIS EXERA II COLONOVIDEOSCOPE
OLYMPUS CF TYPE Q180AL/I
OLYMPUS CF TYPE H180AL/I
OLYMPUS PCF TYPE Q180AL/I

Contents
i
EVIS EXERA II GIF/CF/PCF TYPE 180 Series OPERATION MANUAL
Contents
Symbols......................................................................................... 1
Important Information — Please Read Before Use.................... 2
Intended use ............................................................................................ 2
Applicability of endoscopy and endoscopic treatment .............................. 3
Instruction manual .................................................................................... 3
User qualifications..................................................................................... 4
Instrument compatibility ........................................................................... 4
Reprocessing before the first use/reprocessing and storage after use .... 4
Spare equipment....................................................................................... 5
Maintenance management ....................................................................... 5
Prohibition of improper repair and modification ........................................ 5
Signal words ............................................................................................. 5
Warnings and cautions ............................................................................. 6
Examples of inappropriate handling.......................................................... 11
Chapter 1 Checking the Package Contents............................ 12
Chapter 2 Instrument Nomenclature and Specifications ...... 16
2.1 Nomenclature.................................................................................. 16
2.2 Endoscope functions....................................................................... 22
2.3 Specifications.................................................................................. 24
2.4 Attaching the chain for water-resistant cap (MAJ-1119) ................. 32
Chapter 3 Preparation and Inspection .................................... 35
3.1 Preparation of the equipment.......................................................... 36
3.2 Inspection of the endoscope ........................................................... 37
3.3 Preparation and inspection of accessories ..................................... 43
3.4 Attaching accessories to the endoscope ........................................ 47
3.5 Inspection and connection of ancillary equipment .......................... 50
3.6 Inspection of the endoscopic system .............................................. 53
Chapter 4 Operation ................................................................. 58
4.1 Insertion .......................................................................................... 62
4.2 Using endo-therapy accessories..................................................... 70
4.3 Withdrawal of the endoscope.......................................................... 76
4.4 Transportation of the endoscope .................................................... 77

Contents
ii EVIS EXERA II GIF/CF/PCF TYPE 180 Series OPERATION MANUAL
Chapter 5 Troubleshooting ...................................................... 79
5.1 Troubleshooting guide .................................................................... 79
5.2 Withdrawal of the endoscope with an abnormality.......................... 83
5.3 Returning the endoscope for repair................................................. 86
Appendix........................................................................................ 87
System chart ............................................................................................ 87
EMC information........................................................................................ 101

Symbols
1
EVIS EXERA II GIF/CF/PCF TYPE 180 Series 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
Single use only
Lot number
Manufacturer
Authorized representative in the European Community

2
Important Information — Please Read Before Use
EVIS EXERA II GIF/CF/PCF TYPE 180 Series OPERATION MANUAL
Important Information — Please Read
Before Use
Intended use
These instruments have 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.
Use the EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE GIF-N180 for
transoral or transnasal endoscopy and endoscopic surgery within the upper
digestive tract (including the esophagus, stomach and duodenum).
Use the EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE, GIF-Q180,
GIF-H180 for endoscopy and endoscopic surgery within the upper digestive tract
(including the esophagus, stomach and duodenum).
Use the EVIS EXERA II COLONOVIDEOSCOPE CF-Q180AL/I, CF-H180AL/I,
PCF-Q180AL/I for endoscopy and endoscopic surgery within the lower digestive
tract (including the anus, rectum, sigmoid colon, colon and ileocecal valve).
Do not use these instruments for any purpose other than their intended uses.
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.

Important Information — Please Read Before Use
3
EVIS EXERA II GIF/CF/PCF TYPE 180 Series OPERATION MANUAL
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.
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.

4
Important Information — Please Read Before Use
EVIS EXERA II GIF/CF/PCF TYPE 180 Series OPERATION MANUAL
User qualifications
If there is an official standard on user qualifications to perform endoscopy and
endoscopic treatment that is defined by the medical administration or other
official institutions, such as academic societies on endoscopy, follow that
standard. If there is no official qualification standard, 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.
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.
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.

Important Information — Please Read Before Use
5
EVIS EXERA II GIF/CF/PCF TYPE 180 Series OPERATION MANUAL
Spare equipment
Be sure to prepare another endoscope to avoid that the examination will be
interrupted due to equipment failure or malfunction.
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 which an irregularity is
suspected should not be used, but should be inspected by following Section 5.1,
“Troubleshooting guide” on page 79. If the irregularity is still suspected after
inspection, contact Olympus.
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 can result.
Equipment which 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.

6
Important Information — Please Read Before Use
EVIS EXERA II GIF/CF/PCF TYPE 180 Series OPERATION MANUAL
Indicates additional helpful information.
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 whose cover lists the model of your
endoscope. 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. If performing
high-frequency cauterization becomes necessary while the
patient wears a metallic object, it may cause burns on the
patient in areas around the metallic object.
• 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.
• When performing transnasal insertion of the GIF-N180,
please follow the cautions below.
−The shape and size of the nasal cavity and its suitability
for transnasal insertion may vary from patient to patient.
No endoscope, including this one, can always be inserted
transnasally with all patients. Before proceeding, always
be sure to confirm that transnasal insertion is possible
with the patient. Otherwise, operator and/or patient injury
can result, or the endoscope could become lodged and be
difficult to withdraw.