Olympus VISERA ENF-V2 User manual

(For PAL type only)
INSTRUCTIONS
VISERA RHINO-LARYNGO VIDEOSCOPE
OLYMPUS ENF TYPE V2

Contents
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VISERA RHINO-LARYNGO VIDEOSCOPE ENF-V2
Contents
Symbols......................................................................................... 1
Important Information — Please Read Before Use.................... 2
Intended use ............................................................................................ 2
Applicability of endoscopy and endoscopic treatment ............................. 2
Instruction manual .................................................................................... 2
User qualifications .................................................................................... 3
Instrument compatibility ........................................................................... 3
Reprocessing before the first use/reprocessing and storage after use .... 3
Spare equipment....................................................................................... 4
Maintenance management ....................................................................... 4
Prohibition of improper repair and modification ........................................ 4
Signal words ............................................................................................. 4
Warnings and cautions ............................................................................. 5
Precaution for disappeared or frozen endoscopic image.......................... 10
Examples of inappropriate handling.......................................................... 11
Chapter 1 Checking the Package Contents............................ 13
Chapter 2 Instrument Nomenclature and Specifications ...... 14
2.1 Nomenclature.................................................................................. 14
2.2 Endoscope functions....................................................................... 16
2.3 Specifications.................................................................................. 17
Chapter 3 Preparation and Inspection .................................... 19
3.1 Preparation of the equipment.......................................................... 20
3.2 Preparation and inspection of the endoscope................................. 21
3.3 Preparation, inspection and connection of ancillary equipment...... 23
3.4 Inspection of the endoscopic system .............................................. 24
Chapter 4 Operation ................................................................. 26
4.1 Insertion .......................................................................................... 28
4.2 Withdrawal of the endoscope.......................................................... 30
Chapter 5 Reprocessing: General Policy................................ 31
5.1 Notes for cleaning, disinfection and sterilization ............................. 31
5.2 Precautions ..................................................................................... 31

Contents
ii VISERA RHINO-LARYNGO VIDEOSCOPE ENF-V2
Chapter 6 Recommended Reprocessing Methods and
Chemical Agents ..................................................... 35
6.1 Compatibility summary.................................................................... 35
6.2 Detergent solution........................................................................... 38
6.3 Ultrasonic cleaning.......................................................................... 39
6.4 Disinfectant solution ........................................................................ 40
6.5 Rinsing water .................................................................................. 40
6.6 Automatic cleaning/disinfection....................................................... 41
6.7 Ethylene oxide gas sterilization....................................................... 42
6.8 Steam sterilization (autoclaving) of accessories ............................. 44
Chapter 7 Cleaning, Disinfection and Sterilization Procedures
for Endoscopic Instruments .................................. 47
7.1 Required reprocessing equipment .................................................. 47
7.2 Cleaning, disinfection and sterilization procedures ......................... 51
7.3 Precleaning ..................................................................................... 52
7.4 Transportation of the endoscope .................................................... 54
7.5 Leakage testing............................................................................... 55
7.6 Manual cleaning .............................................................................. 60
7.7 Disinfection ..................................................................................... 63
7.8 Rinsing and drying after disinfection ............................................... 65
7.9 Automatic cleaning/disinfection....................................................... 66
7.10 Sterilization ..................................................................................... 67
Chapter 8 Maintenance Procedures of Equipments for
Reprocessing .......................................................... 69
Chapter 9 Storage, Transporting Outside the Hospital and
Disposal ................................................................... 70
9.1 Storage ........................................................................................... 70
9.2 Transporting outside the hospital.................................................... 71
9.3 Disposal .......................................................................................... 71
Chapter 10 Troubleshooting ...................................................... 72
10.1 Troubleshooting guide .................................................................... 73
10.2 Withdrawal of the endoscope with an abnormality.......................... 74
10.3 Returning the endoscope for repair................................................. 75
Appendix........................................................................................ 76
System chart ............................................................................................ 76
EMC information........................................................................................ 79

Symbols
1
VISERA RHINO-LARYNGO VIDEOSCOPE ENF-V2
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.
Caution
Type BF applied part
Endoscope
Manufacturer
Authorized representative in the European Community
Lot number
Serial number

2
Important Information — Please Read Before Use
VISERA RHINO-LARYNGO VIDEOSCOPE ENF-V2
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, and other ancillary
equipment for endoscopic diagnosis within the ear, nasal lumens and airway
anatomy (including nasopharyngeal and bronchus).
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 of the applicability of endoscopy and endoscopic
treatment that is defined by the hospital’s administration or other official
institutions such as academic societies of 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
instruments as instructed.
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.

Important Information — Please Read Before Use
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VISERA RHINO-LARYNGO VIDEOSCOPE ENF-V2
User qualifications
If there is an official standard of the qualification of endoscopy and endoscopic
treatment that is defined by the medical administration or other official
institutions such as the academic society of endoscopy, follow the 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 otorhinolaryngology, etc.). The medical
safety manager of the hospital or person in charge of the department should
select a physician who is performing the planned endoscopy and endoscopic
treatment safely by following the official guidelines set by the academic society
of endoscopy, etc., and considering the difficulty of each type of endoscopy and
endoscopic treatment.
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 and operator injury and/or equipment damage.
This instrument complies with the EMC standard for medical electrical
equipment, edition 4 (IEC 60601-1-2: 2014).
When connecting to an instrument that complies with a previous edition of the
EMC standard for medical electrical equipment edition, the EMC characteristics
could be vulnerable.
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 Chapter 5, “Reprocessing: General Policy” through Chapter
7, “Cleaning, Disinfection and Sterilization Procedures for Endoscopic
Instruments”.
After using this instrument, reprocess and store it according to the instructions
given in Chapter 5, “Reprocessing: General Policy” through Chapter 9, “Storage,
Transporting Outside the Hospital and Disposal”. Improper and/or incomplete
reprocessing or storage can present an infection-control risk, cause equipment
damage or reduce performance.

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Important Information — Please Read Before Use
VISERA RHINO-LARYNGO VIDEOSCOPE ENF-V2
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
10.1, “Troubleshooting guide” on page 73. 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.
Indicates additional helpful information.

Important Information — Please Read Before Use
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VISERA RHINO-LARYNGO VIDEOSCOPE ENF-V2
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.
• Push the video connector until it clicks into the video system
center, then confirm that the video connector is securely
attached by pulling it gently. Improper connection will
damage the CCD. A damaged CCD will display no image
and make the distal end hot, which could cause operator
and/or patient burns.
• Never perform angulation control forcibly. Never forcefully
pull, twist or rotate the angulated bending section. Patient
injury can result.
• Never insert or withdraw the endoscope’s insertion tube while
the UP/DOWN angulation is locked. Patient injury and/or
equipment damage can result.
• Never operate the bending section, perform suction, insert or
withdraw the endoscope’s insertion tube without viewing the
endoscopic image. Patient injury can result.
• Never operate the bending section, perform suction, or insert
or withdraw the endoscope’s insertion tube while the image is
frozen. Patient injury can result.
• 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.
• Transnasal insertion is accompanied by the risk of
inflammation of the nasal cavity. If this happens, the nasal
passage will be constricted, making it more difficult to
withdraw the endoscope. In this case, do not use force to
withdraw the endoscope because patient injury such as
bleeding or perforation may result.

6
Important Information — Please Read Before Use
VISERA RHINO-LARYNGO VIDEOSCOPE ENF-V2
• Transnasal insertion is accompanied by the risk of bleeding
in the nasal cavity. Be sure to be prepared to deal with any
bleeding. When withdrawing the endoscope, observe the
inside of the nasal cavity to ensure that there is no bleeding.
Even when the endoscope has been withdrawn without
bleeding, do not allow the patient to blow his or her nose
strongly because this could cause it to start bleeding.
• Before transnasal insertion, apply the appropriate
pretreatment and lubrication to the patient to enlarge the
nasal cavity. Otherwise, operator and/or patient injury can
result or the endoscope could become lodged and be difficult
to withdraw. Otherwise, the treatment will have no effect. The
effects of the pretreatment agent and lubricant will decrease
the longer the procedure lasts. Apply the pretreatment agent
or lubricant as required during the procedure – for example,
when withdrawal seems to be difficult.
• Transnasal insertion of the endoscope should be performed
carefully. If resistance to insertion is felt, or the patient reports
pain, stop insertion immediately. Otherwise, operator and/or
patient injury can result or the endoscope could become
lodged and be difficult to withdraw.
• If it becomes impossible to withdraw the transnasally inserted
endoscope, pull its distal end out of the mouth, cut the
flexible tube using wire cutters and, after ensuring that the cut
section will not injure the body cavity or nasal cavity of the
patient, withdraw the endoscope carefully. Therefore, always
prepare wire cutters in advance.
• Do not touch the metal parts of the light guide and the light
guide connector immediately after removing the light guide
from the endoscope and light source because they are
extremely hot.
• Although the illumination light emitted from the endoscope’s
distal end is required for endoscopic observation and
treatment, it may also cause alteration of living tissues such
as protein denaturation of living tissue and perforation of the
tissue by inappropriate using.
Observe the following warnings on the illumination.
Always set the minimum required brightness.
Please note that the brightness of the image on a video
monitor may differ from the actual brightness at the distal
end of the endoscope.