ENF-V4 and ENF-VH2 RHINO-LARYNGO VIDEOSCOPE Operation Manual Sept 2018.pdf
Page 1
OPERATION MANUAL
INSTRUCTIONS
RHINO-LARYNGO VIDEOSCOPE
OLYMPUS ENF-V4
OLYMPUS ENF-VH2
Symbols
1
Important Information — Please Read Before
Use
2
Chapter 1
Checking the Package Contents
13
Chapter 2
Instrument Nomenclature and
Specifications
15
Chapter 3
Preparation and Inspection
21
Chapter 4
Operation
33
Chapter 5
Troubleshooting
43
Appendix
Refer to the endoscope’s companion manual, the “REPROCESSING MANUAL” with your
endoscope model listed on the cover, for reprocessing information.
49
Page 3
Contents
Contents
Symbols .............................................................................................................................. 1
Important Information — Please Read Before Use ......................................................... 2
Intended use .......................................................................................................................... 2
Contraindications ................................................................................................................... 2
Applicability of endoscopy and endoscopic treatment (for ENF-VH2) ................................... 3
Instruction manual ................................................................................................................. 3
User qualifications ................................................................................................................. 4
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
Precautions ............................................................................................................................ 6
Precaution for disappeared or frozen endoscopic image ..................................................... 11
Examples of inappropriate handling .................................................................................... 12
Chapter 1 Checking the Package Contents ....................................... 13
1.1
Checking the package contents ........................................................................... 13
Chapter 2 Instrument Nomenclature and Specifications .................. 15
2.1
Nomenclature and functions ................................................................................. 15
Control section, insertion section ......................................................................................... 16
Light guide connector, video connector ............................................................................... 17
2.2
Specifications ......................................................................................................... 18
Environment ........................................................................................................................ 18
Specifications ...................................................................................................................... 19
Chapter 3 Preparation and Inspection ................................................ 21
3.1
The workflow of preparation and inspection ....................................................... 21
3.2
Preparation of the equipment ............................................................................... 23
3.3
Inspection of the endoscope ................................................................................. 24
Inspection of the endoscope ................................................................................................ 24
Inspection of the bending mechanism ................................................................................. 27
3.4
Inspection of ancillary equipment ........................................................................ 28
3.5
Connection of the endoscope and ancillary equipment ..................................... 29
Preparation .......................................................................................................................... 29
Connection to the light source and video system center ..................................................... 29
3.6
Inspection of the endoscopic system .................................................................. 31
Inspection of the ancillary equipment .................................................................................. 31
Inspection of the endoscopic image .................................................................................... 31
Inspection of the remote switches ....................................................................................... 32
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Contents
Chapter 4 Operation ............................................................................. 33
4.1
Precautions ............................................................................................................. 33
4.2
Insertion .................................................................................................................. 36
Holding and manipulating the endoscope ...........................................................................
Insertion of the endoscope ..................................................................................................
Angulation of the distal end .................................................................................................
Observation of the endoscopic image .................................................................................
4.3
36
37
38
39
Using EndoTherapy accessories (for ENF-VH2) .................................................. 40
Laser cauterization .............................................................................................................. 40
4.4
Withdrawal of the endoscope ................................................................................ 41
4.5
Transportation of the endoscope .......................................................................... 42
Transporting within the hospital ........................................................................................... 42
Transporting outside the hospital ......................................................................................... 42
Chapter 5 Troubleshooting .................................................................. 43
5.1
Troubleshooting ..................................................................................................... 43
5.2
Troubleshooting guide ........................................................................................... 44
Image quality or brightness ................................................................................................. 44
Other .................................................................................................................................... 44
5.3
Withdrawal of the endoscope with an irregularity ............................................... 45
Withdrawal when the WLI and NBI endoscopic images appear on the monitor .................. 45
Withdrawal when either the WLI or the NBI endoscopic image does not appear
on the monitor ...................................................................................................................... 46
Withdrawal when no endoscopic image appears on the monitor or a frozen image
cannot be restored ............................................................................................................... 46
5.4
Returning the endoscope for repair ...................................................................... 47
Appendix ................................................................................................. 49
Combination equipment .................................................................................................. 49
System chart ........................................................................................................................ 49
Reprocessing equipment ..................................................................................................... 51
EMC information .............................................................................................................. 52
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Symbols
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:
Symbol
Blue
Description
Refer to instructions.
Refer to instructions.
Caution
Endoscope
TYPE BF applied part
Manufacturer
Date of Manufacture
Authorized representative in the European Community
Serial number
Ingress protection rating is 7.
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Important Information — Please Read Before Use
Important Information — Please Read Before Use
Intended use
ENF-V4
This instrument is intended to be used with an Olympus video system center, light source,
documentation equipment, display monitor, and other ancillary equipment for endoscopic
diagnosis.
This instrument is indicated for use within the ear, nasal lumens, oral cavity, and airway anatomy
(including nasopharynx and trachea).
ENF-VH2
This instrument is intended to be used with an Olympus video system center, light source,
documentation equipment, display monitor, EndoTherapy accessories, and other ancillary
equipment for endoscopic diagnosis and treatment.
This instrument is indicated for use within the ear, nasal lumens, oral cavity, and airway anatomy
(including nasopharynx and trachea).
Contraindications
None known.
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Important Information — Please Read Before Use
Applicability of endoscopy and endoscopic treatment (for
ENF-VH2)
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.
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 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
NBI (Narrow Band Imaging) observation:
This is optical-digital observation using narrowband light.
WLI (White Light Imaging) observation:
This is observation using white light.
Image sensor:
The image sensor is a device that converts light into electrical signals.
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Important Information — Please Read Before Use
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 otorhinolaryngology, 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 “Combination equipment” on page 49 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 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 reprocessed 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.
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Important Information — Please Read Before Use
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
periodically inspect the items specified in this manual following applicable regulations, guidelines, etc.
required of you. An endoscope with an observed irregularity should not be used, but should be
inspected by following Section 5.2, “Troubleshooting guide”. If the irregularity is still observed 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 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:
WARNING
Indicates a potentially hazardous situation which, if not avoided, could result in
death or serious injury.
CAUTION
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.
NOTE
Indicates additional helpful information.
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Important Information — Please Read Before Use
Precautions
Follow the warnings and cautions given below when handling this endoscope. This information is to be
supplemented by the warnings and cautions given in each chapter.
WARNING
• Do not use this endoscope for any purpose other than its intended use. Patient or
operator injury and/or equipment damage may result.
• After using this endoscope, 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.
• Do not strike, hit, or drop the distal end, insertion tube, bending section, control
section, universal cord, video connector, or light guide connector of the endoscope.
Also, do not bend, pull, or twist the distal end, insertion tube, bending section,
control section, universal cord, video connector, or light guide 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
may result. It may also become impossible to straighten the bending section during
an examination.
• Never operate the bending section, insert or withdraw the endoscope’s insertion
section, or use the EndoTherapy accessories without viewing the endoscopic
image. Patient injury, bleeding, and/or perforation may result.
• Never use EndoTherapy accessories (for ENF-VH2), insert or withdraw the
insertion section or perform angulation control while the image is frozen. Patient
injury, bleeding, and/or perforation may result.
• If it is difficult to insert the endoscope, do not forcibly insert the endoscope; stop the
endoscopy. Forcible insertion can result in patient injury, bleeding, and/or
perforation.
• Never insert or withdraw the insertion section abruptly or with excessive force.
Patient injury, bleeding, and/or perforation may result.
• Do not touch the light guide on the light guide connector immediately after
removing it from the light source because it is extremely hot. Operator or patient
burns can result.
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Important Information — Please Read Before Use
WARNING
• Although the illumination light emitted from the distal end of the endoscope is
required for endoscopic observation, it may also cause alteration of living tissues
such as protein denaturation of living tissue and perforation of the tissue through
improper usage. Observe the following warnings for illumination.
Always set the minimum required brightness. The brightness of the image on a
monitor may differ from the actual brightness at the distal end of the endoscope.
Pay special attention to the brightness level setting of the light source,
particularly when operating the electronic shutter function of a video system
center. When both a light source and a video system center have the automatic
brightness control function, use the function on the light source. This function
can better maintain the illumination level. Refer to the instruction manual for the
light source and the video system center for further details.
Always maintain a suitable distance necessary for adequate viewing while using
the minimum level of illumination for the minimum amount of time. Do not use
close stationary viewing or leave the distal end of the endoscope close to the
mucous membrane for a long time without necessity.
When the endoscope will not be used for a long period, be sure to turn OFF the
light source or activate the light shield function (standby mode, etc.) so that the
endoscope is not illuminated unnecessarily.
• Push the video connector into the video system center until it clicks, then confirm
that the video connector is securely attached by pulling it gently. Improper
connection will damage the image sensor. The damaged image sensor will display
no image and make the distal end of the endoscope hot, which could cause
operator and/or patient burns.
• Do not insert the video connector while the electrical contacts are wet and/or dirty.
This may result in an electric shock, causing severe damage to the endoscope and
compromising patient and/or operator safety.
• If the endoscopic image becomes dimmer during the procedure, it may indicate that
blood or mucus is adhering to the examination light outlet on the distal end of the
endoscope or that the examination light outlet has been discolored. Immediately
withdraw the endoscope from the patient, remove blood or mucus, and confirm that
the examination light outlet has no irregularities to use it again. If you continue to
use the endoscope with its obstructed or discolored examination light outlet, the
temperature at the distal end of the endoscope may rise, which may cause patient
injury or operator and/or patient burns.
• When the endoscopic image does not appear on the monitor, the image sensor
may have been damaged. Turn the video system center OFF immediately.
Continued power supply in such a case will cause the distal end of the endoscope
to become hot and could cause operator and/or patient burns.
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Important Information — Please Read Before Use
WARNING
• Do not rely on the NBI observation mode alone for primary detection of lesions or to
make a decision regarding any potential diagnostic or therapeutic intervention.
• 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 into all patients. Before proceeding, always be sure to confirm
that transnasal insertion is possible with the patient by considering both the size of
the patient’s nasal cavity as well as the size of the endoscope’s insertion section.
Otherwise, patient injury can result or the endoscope could become lodged and
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, bleeding, and/or perforation may result.
• 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, patient injury can result or the
endoscope could become lodged and difficult to withdraw. When applying a
pretreatment agent through a tube, insert the tube into the same path as the path
planned for the endoscope’s insertion. 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 the insertion immediately. Patient
injury can result or the endoscope could become lodged and difficult to withdraw.
• If it becomes impossible to withdraw the transnasally inserted endoscope, pull the
distal end of the endoscope 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.
• When performing the NBI observation of an oral cavity, cut off the extraneous light
as much as possible, such as dimming the room light. Otherwise, the examination
might not be done properly.
• When using the electronic zoom function of the video system center, never insert or
withdraw the endoscope’s insertion section or use EndoTherapy accessories while
the image is magnified. Patient injury, bleeding, and/or perforation can result.
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Important Information — Please Read Before Use
WARNING
• Do not use high-frequency electrosurgical equipment with this endoscope. The
electrode of the electrosurgical equipment can get in contact with the endoscope,
and it may cause patient injury, burns, bleeding, perforations, and/or equipment
damage.
• For ENF-V4
Do not use a laser unit with this endoscope. Endoscopic observation may not be
performed normally.
CAUTION
• Do not pull the universal cord and video cable during an examination. The light
guide connector will be pulled out from the output socket of the light source and the
endoscopic image will disappear.
• Do not coil the insertion tube, universal cord, or video cable with a diameter of less
than 10 cm. Equipment damage may result.
• Do not attempt to bend or twist the endoscope’s insertion section with excessive
force. The insertion section may be damaged.
• Do not apply shock to the distal end of the endoscope, in particular the objective
lens surface at the distal end of the endoscope. An abnormal endoscopic image
may result.
• If the endoscope is dropped or the distal end of the endoscope receives a hard
impact, the endoscope may be damaged even if no visible damage of the lens on
the distal end of the endoscope can be found. In this case, stop using the
endoscope, and contact Olympus.
• 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.
• Do not put or press the video connector and light guide connector on the insertion
section when transporting or reprocessing. The insertion section may be damaged.
• Turn the video system center ON only when the video connector is connected to
the video system center. In particular, confirm that the video system center is OFF
before connecting or disconnecting the video connector. Failure to do so can result
in equipment damage, including destruction of the image sensor.
• 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 cause water leaks.
• Do not hit or bend the electrical contacts on the video connector. The connection to
the video system center may be impaired and faulty contact can result.
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Important Information — Please Read Before Use
CAUTION
• Do not pull the video cable during an examination. The endoscopic image may not
be visible.
• Electromagnetic interference may occur on this endoscope near equipment
marked with the following symbol or other portable and mobile RF (Radio
Frequency) communications equipment, such as cellular phones. If
electromagnetic interference occurs, mitigation measures may be necessary, such
as reorienting or relocating this endoscope, or shielding the location.
• Be sure that this endoscope is not used adjacent to or stacked with other
equipment (other than the components of this endoscope or system) to avoid
electromagnetic interference.
NOTE
• This endoscope contains a memory chip that stores information about the
endoscope and communicates this information to the video system center
OTV-S190/S200/S300 or CV-170.
• When the endoscope gets strong static electricity, noise may be observed in the
endoscopic image. This does not indicate a malfunction.
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Important Information — Please Read Before Use
Precaution for disappeared or frozen endoscopic image
WARNING
• If the endoscopic image disappears unexpectedly or the frozen image cannot be
restored during an examination, immediately stop using the endoscope and
withdraw it from the patient as described in Section 5.3, “Withdrawal of the
endoscope with an irregularity”. Continued use of the endoscope under this
condition could result in patient injury, bleeding, and/or perforation.
• Follow the precautions given below. Otherwise, the endoscopic image may
disappear unexpectedly or the frozen image may not be restored during the
examination.
Connect the video connector to the video system center completely by pushing
the video connector until it clicks. Otherwise, faulty contact can result.
Do not bend, hit, pull, or twist the insertion section, bending section, control
section, universal cord, video cable, video connector, and light guide connector.
The endoscope may be damaged, and water leakage and/or breakage of
internal parts like the image sensor cable can result.
Make sure that the video connector and its electrical contacts are completely dry
and clean before connecting the video connector to the video system center. If
the endoscope is used with the electrical contacts wet and/or dirty, the
endoscope and video system center may malfunction.
If air bubbles emerge from the endoscope continuously during the leakage test,
do not use the endoscope. Water may enter the endoscope and cause a short
circuit. This may result in image sensor damage.
CAUTION
• Turn the video system center ON only when the video connector is connected to
the video system center. In particular, confirm that the video system center is OFF
before connecting or disconnecting the video connector. Failure to do so can result
in equipment damage, including destruction of the image sensor.
• Do not hit or bend the electrical contacts on the video connector. The connection to
the video system center may be impaired and faulty contact can result.
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Important Information — Please Read Before Use
Examples of inappropriate handling
Details on clinical endoscopic technique are the responsibility of trained specialists. Patient safety in
endoscopic examinations and endoscopic treatment can be ensured through appropriate handling by
the physician and the medical facility. Examples of inappropriate handling are described below.
WARNING
• The endoscope has not been designed for use in retroflexed observation.
Performing retroflexed observation in a narrow lumen may make it impossible to
straighten the angle of the bending section and/or withdraw the endoscope from
the patient. Retroflexed observation should be performed only when the usefulness
of doing so is determined to be greater than the risk that is posed to the patient.
• For ENF-VH2
Inserting, withdrawing, and using EndoTherapy accessories without a clear
endoscopic image may cause patient injury, burns, bleeding, and/or perforation.
• Inserting or withdrawing the endoscope or operating the bending section without a
clear endoscopic image may cause patient injury, bleeding, and/or perforation.
• For reasons described below, do not rely on the NBI*1 observation mode alone for
primary detection of lesions to make a decision regarding any potential diagnostic
or therapeutic intervention.
NBI has not been demonstrated to increase the yield or sensitivity of finding any
specific mucosal lesion.
NBI has not been demonstrated to aid in differentiating and establishing the
presence or absence of dysplasia or neoplastic changes within mucosa or
mucosal lesions.
*1
12
Narrow Band Imaging. For more details, refer to the instruction manual for
the video system center OTV-S190/S200/S300 or CV-170.
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1.1 Checking the package contents
Chapter 1
1.1
Checking the Package
Contents
Ch.1
Checking the package contents
Match all items in the package with the components shown below. Inspect each item for damage. If the
endoscope is damaged, a component is missing, or you have any questions, do not use the items;
immediately contact Olympus.
Endoscope
ENF-V4/VH2
Accessories
ETO cap (MB-156)
Operation manual
ENF-V4, ENF-VH2 OPERATION MANUAL
Reprocessing manual
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1.1 Checking the package contents
Ch.1
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2.1 Nomenclature and functions
Chapter 2
Instrument Nomenclature
and Specifications
The instrument nomenclature, functions, and specifications are described in this chapter.
2.1
Nomenclature and functions
ENF-V4, ENF-VH2 OPERATION MANUAL
Ch.2
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2.1 Nomenclature and functions
Control section, insertion section
3
7
1
Ch.2
2
4
6
5
8
No.
Nomenclature
Description
1
UP/DOWN
angulation control
lever
When this lever is turned in the “U” direction, the bending section moves UP; when the
lever is turned in the “D” direction, the bending section moves DOWN.
2
Boot
Prevents the junction between the insertion tube and control section from bending.
3
Control section
Operates the endoscope, such as controlling angulation.
4
Insertion section
This section is inserted into the patient body cavity.
5
Distal end
The objective lens and examination light outlet are on this distal end.
6
Bending section
The bending section moves the distal end of the endoscope when the UP/DOWN
angulation control lever is operated.
7
Insertion tube
Connects the control section and bending section.
8
Remote switches 1
to 4
The functions of the remote switches 1 to 4 can be selected on the video system center.
Refer to the instruction manual for the video system center when setting these functions.
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2.1 Nomenclature and functions
Light guide connector, video connector
11
12
10
9
13
Ch.2
14
18
17
16
No.
Nomenclature
15
Description
9
Light guide
Connects the endoscope to the light source and transmits light to the distal end of the
endoscope.
10
Venting connector
Attach the ETO cap or leakage tester here.
11
ETO cap
(MB-156)
The ETO cap equalizes the outer and inner pressure of the endoscope. The cap must
be attached prior to gas sterilization (ethylene oxide gas, STERRAD®, etc.) and aeration
and removed prior to immersion or clinical examination. The cap must also be attached
when the endoscope is transported outside the hospital (shipment, return for repairs,
etc.).
12
Light guide
connector
The light guide connector connects the endoscope to the output socket of the light
source and transmits light from the light source to the distal end of the endoscope.
13
Universal cord
Connects the light guide connector and the control section.
14
Video cable
Connects the light guide connector and the video connector.
15
Video connector
The video connector connects the endoscope to the video connector socket of the video
system center so that the endoscopic image becomes visible. The endoscope contains
a memory chip that stores information about the endoscope and communicates this
information to the video system center OTV-S190/S200/S300 or CV-170. For more
details, refer to the instruction manual for the OTV-S190/S200/S300 or CV-170.
16
Electrical contacts
Connects the video system center and the endoscope electrically.
17
UP mark
When the video connector is connected to the video system center, this mark is facing
upward.
18
Serial number
The serial number is marked here.
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2.2 Specifications
2.2
Specifications
Environment
Operating
environment
Ch.2
Ambient
temperature
10 – 40C (50 – 104F)
Relative humidity
30 – 85%
Atmospheric
pressure
700 – 1060 hPa
(0.7 – 1.1 kgf/cm2)
(10.2 – 15.4 psia)
Standard storage
environment (e.g.
within the
hospital)
Ambient
temperature
5 – 40C (41 – 104F)
Relative humidity
10 – 95%
Atmospheric
pressure
700 – 1060 hPa
(0.7 – 1.1 kgf/cm2)
(10.2 – 15.4 psia)
Transportation
environment
(conditions during
transportation and
short-term
storage)
Ambient
temperature
–47 to +70C (–52.6 to +158F)
Relative humidity
10 – 95%
Atmospheric
pressure
700 – 1060 hPa
(0.7 – 1.1 kgf/cm2)
(10.2 – 15.4 psia)
18
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Page 23
2.2 Specifications
Specifications
Endoscope functions
Model
Optical system
ENF-V4
ENF-VH2
90
110
0Forward viewing)
0Forward viewing)
3.5 – 50 mm
5 – 50 mm
ø 2.6 mm
ø 3.9 mm
UP
UP
Field of view
Direction of view
Depth of field
Insertion section Distal end outer
diameter
Distal end enlarged
1 Objective lens
2 Examination light
outlet
1
2
2
Ch.2
1
2
2
DOWN
DOWN
ø 2.9 mm
ø 3.6 mm
300 mm
300 mm
UP 130
DOWN 130
UP 130
DOWN 130
500 mm
500 mm
Available
Available
Available
Available
Electronic shutter function
Available
Available
function*1
Available
Available
High-frequency treatment
Not available
Not available
Laser treatment
Not available
Available
Insertion tube outer
diameter
Insertion section
working length
Bending section
Angulation range
Total length
NBI observation
mode*1
Records of endoscope’s
information*1
*1
Electronic zoom
*1 For more details, refer to the instruction manual for the OTV-S190/S200/S300 or CV-170.
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19
Page 24
2.2 Specifications
Common specifications
Medical Devices Directive
This device complies with the requirements of Directive 93/42/EEC
concerning medical devices.
Classification: Class II a
RoHS Directive
Ch.2
This device complies with the requirements of Directive
2011/65/EU concerning electrical and electronic equipment.
EMC
Applied standard
IEC 60601-1-2: 2001
IEC 60601-1-2: 2007
IEC 60601-1-2: 2014
IEC 60601-2-18: 1996
IEC 60601-2-18: 2009
• 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.
• CISPR 11 of emission:
Group 1, Class B
Degree of protection against electric shock
TYPE BF applied part
Ingress protection rating
IPX7
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3.1 The workflow of preparation and inspection
Chapter 3
Preparation and Inspection
The equipment prepared before using this endoscope and procedures for the inspection of the
endoscope and equipment are described in this chapter.
3.1
The workflow of preparation and inspection
The workflow of preparation and inspection is shown below.
Before each case, prepare and inspect this endoscope as instructed below. Inspect other equipment to
be used with this endoscope as instructed in their respective instruction manuals. Should any
irregularity be observed after inspection, follow the instructions as described in Chapter 5,
“Troubleshooting”. If this endoscope malfunctions, do not use it. Return it to Olympus for repair as
described in Section 5.4, “Returning the endoscope for repair”.
WARNING
• Never use the endoscope on a patient if any irregularity is observed. The irregular
endoscope may compromise patient or user safety and may result in more severe
equipment damage. In addition, it may pose an infection control risk.
• This endoscope was not reprocessed before shipment. Before using this
endoscope for the first time, reprocess it according to the instructions as described
in the endoscope’s companion “REPROCESSING MANUAL” with your endoscope
model listed on the cover.
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21
Ch.3
Page 26
3.1 The workflow of preparation and inspection
Ch.3
22
1
Prepare the equipment to be used with the endoscope.
2
Inspect the endoscope.
3
Inspect the ancillary equipment.
4
Connect the endoscope to the ancillary equipment.
5
Inspect the endoscopic system.
Section 3.2 on page 23
Section 3.3 on page 24
Section 3.4 on page 28
Section 3.5 on page 29
Section 3.6 on page 31
ENF-V4, ENF-VH2 OPERATION MANUAL