clv-190_light_source_evis_exera_iii_instructions_oc.pdf
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INSTRUCTIONS
EVIS EXERA III XENON LIGHT SOURCE
Labels and Symbols
1
Important Information — Please Read Before
Use
3
Summary of the Equipment Functions
12
Chapter 1
Checking the Package Contents
15
Chapter 2
Nomenclature and Functions
17
Chapter 3
Installation and Connection
27
Chapter 4
Inspection
41
Chapter 5
Operation
65
Chapter 6
Lamp Replacement
81
Chapter 7
Care, Storage, and Disposal
93
Chapter 8
Troubleshooting
97
OLYMPUS CLV-190
Appendix
USA: CAUTION: Federal law restricts this device to sale by or on the order of a physician.
103
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Contents
Contents
Labels and Symbols .......................................................................................................... 1
Important Information — Please Read Before Use ......................................................... 3
Intended use .......................................................................................................................... 3
Applicability of endoscopy and endoscopic treatment ........................................................... 3
Instruction manual ................................................................................................................. 3
User qualifications ................................................................................................................. 5
Instrument compatibility ......................................................................................................... 6
Repair and modification ......................................................................................................... 6
Signal words .......................................................................................................................... 6
Dangers, warnings, and cautions .......................................................................................... 7
Cardiac applications ............................................................................................................. 11
Summary of the Equipment Functions .......................................................................... 12
Chapter 1 Checking the Package Contents ....................................... 15
1.1
Checking the package contents list ..................................................................... 15
Chapter 2 Nomenclature and Functions ............................................ 17
2.1
Nomenclature and functions ................................................................................. 17
2.2
Front panel .............................................................................................................. 19
2.3
Rear and side panels .............................................................................................. 24
Chapter 3 Installation and Connection ............................................... 27
3.1
Precautions for installation and connection ........................................................ 27
3.2
Installation workflow .............................................................................................. 28
3.3
Installation of equipment ....................................................................................... 29
Installation on the mobile workstation
(WM-NP2, WM-DP2, WM-NP1, WM-WP1, or WM-DP1) .................................................... 30
Installation in another location ............................................................................................. 32
3.4
Installation of the water container ........................................................................ 33
3.5
Selection of the lamp ignition mode ..................................................................... 33
Manual ignition (MANU) ...................................................................................................... 34
Automatic ignition (AUTO) ................................................................................................... 34
3.6
Connection of the video system center ............................................................... 35
3.7
Connection of the foot switch ............................................................................... 38
3.8
Connection to the AC mains power supply ......................................................... 39
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Contents
Chapter 4 Inspection ............................................................................ 41
4.1
Precautions for inspection .................................................................................... 41
4.2
Inspection workflow ............................................................................................... 42
4.3
Checking the lamp ignition mode ......................................................................... 43
4.4
Connection of an endoscope ................................................................................ 43
4.5
Inspection of the power supply ............................................................................. 46
4.6
Checking the lamp usage indicator ...................................................................... 48
4.7
Inspection of the examination light ...................................................................... 48
4.8
Inspection of the brightness mode selection function ....................................... 50
4.9
Inspection of brightness adjustment .................................................................... 51
Inspection of automatic brightness adjustment ................................................................... 51
Inspection of manual brightness adjustment ....................................................................... 54
4.10 Inspection of the optical-digital observation function ........................................ 56
4.11 Inspection of the transillumination function ........................................................ 58
4.12 Inspection of the high intensity mode .................................................................. 59
4.13 Inspection of air and water feeding ...................................................................... 62
4.14 After inspection ...................................................................................................... 64
Chapter 5 Operation ............................................................................. 65
5.1
Attention to operation ............................................................................................ 65
5.2
Operation workflow ................................................................................................ 68
5.3
Turning the light source ON and igniting the examination lamp ....................... 69
5.4
Setting the brightness mode ................................................................................. 70
5.5
Brightness adjustment ........................................................................................... 71
Automatic brightness adjustment ........................................................................................ 71
Manual brightness adjustment ............................................................................................. 73
5.6
Optical-digital observation .................................................................................... 74
5.7
Transillumination function ..................................................................................... 76
5.8
High intensity mode ............................................................................................... 77
5.9
Air/water feeding .................................................................................................... 78
5.10 Extinguishing the examination lamp .................................................................... 79
5.11 Turning the light source OFF ................................................................................. 80
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Contents
Chapter 6 Lamp Replacement ............................................................. 81
6.1
Replacement of the examination (xenon) lamp ................................................... 81
6.2
Removal of the lamp .............................................................................................. 82
6.3
Insertion of the lamp .............................................................................................. 86
6.4
Lamp usage indicator reset ................................................................................... 91
Chapter 7 Care, Storage, and Disposal .............................................. 93
7.1
Care ......................................................................................................................... 93
The light source ................................................................................................................... 93
Water container ................................................................................................................... 94
7.2
Storage .................................................................................................................... 95
7.3
Disposal .................................................................................................................. 96
Examination lamp ................................................................................................................ 96
The light source or any of its components ........................................................................... 96
Chapter 8 Troubleshooting .................................................................. 97
8.1
Troubleshooting ..................................................................................................... 97
8.2
Troubleshooting guide ........................................................................................... 97
8.3
Returning the light source for repair .................................................................. 102
Appendix ............................................................................................... 103
Combination equipment ................................................................................................ 103
System chart ...................................................................................................................... 103
Water container ................................................................................................................. 106
Transportation, storage, and operating environments .............................................. 107
Specifications ................................................................................................................ 107
EMC information ............................................................................................................ 110
CLV-190 INSTRUCTION MANUAL
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Contents
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CLV-190 INSTRUCTION MANUAL
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Labels and Symbols
Labels and Symbols
Safety-related labels and symbols are attached to the light source at the locations shown below. If
labels or symbols are missing or illegible, contact Olympus.
Rear and side panel
CSA/UL marking
Cautions that the inside is
extremely hot immediately
after the lamp is extinguished.
Indicates to see the instruction
manual for the cable to be
connected.
Lamp model number
Electrical rating
POWER INPUT
100 – 240V
50/60 Hz 600 VA
Manufacturer name
CE marking
Indicates to see the
instruction manual for
replacement of the
examination lamp.
Serial number plate
Product name
Crossed-out wheeled
bin’ symbol
CLV-190 INSTRUCTION MANUAL
Potential equalization
terminal
1
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Labels and Symbols
Front panel
Dry the endoscope connector before insertion.
Back cover of this instruction manual
Symbol
Description
Manufacturer
Authorized representative in the European Community
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Important Information — Please Read Before Use
Important Information — Please Read Before Use
Intended use
The light source is intended to be used with Olympus endoscopes, video system centers, and other
ancillary equipment for endoscopic diagnosis, treatment and video observation.
Do not use the light source for any purpose other than its intended use.
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 administrators 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 the light source 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.
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.
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Important Information — Please Read Before Use
Terms used in this manual
Video system center:
The video system center is a device that converts signals from a videoscope, video
converter, or camera head into monitor images.
Video converter:
The video convertor is a device that connects to a video system center to convert images
from a fiber endoscope into monitor images.
Camera head:
The camera head is a device that connects to a video system center to convert images
from a fiber endoscope or rigid endoscope into monitor images.
Mobile workstation:
The mobile workstation is a special trolley to place the light source and other devices.
Wall mains outlet:
The wall mains outlet is a wall AC mains power outlet socket having an exclusive terminal
for grounding.
Isolation transformer:
The isolation transformer is a safety device that is used to isolate noninsulated equipment
with potentially high leakage currents to decrease the possibility of electric shock.
Automatic brightness adjustment:
The automatic brightness adjustment automatically adjusts the intensity of the light emitted
from the light source so that the endoscopic image will be maintained at constant
brightness even if the distance between the distal end of the endoscope’s insertion tube
and the subject changes.
Transillumination function:
With this function, the distal end of the endoscope emits more intense examination light,
which transmits the body wall of the patient and enables the operator to confirm the
position of the distal end from outside the patient’s body, provided that the operating room
illumination is low.
High intensity mode:
This mode emits brighter illumination light than usual. It is available only with the
endoscopes and light guide cables compatible with this mode.
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Important Information — Please Read Before Use
Normal light observation (WLI (White Light Imaging) observation):
This is observation using white light.
Optical-digital observation:
This is observation using specific filtered light.
NBI (Narrow Band Imaging) observation:
This is optical-digital observation using narrow band light.
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.
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Important Information — Please Read Before Use
Instrument compatibility
Refer to the “ System chart” on page 103 to confirm that the light source is compatible with the
ancillary equipment being used. Using incompatible equipment can result in patient injury or equipment
damage and makes it impossible to obtain the expected functionality.
This instrument complies with the EMC standard for medical electrical equipment, edition 2
(IEC 60601-1-2: 2001) and edition 3 (IEC 60601-1-2: 2007). However, when connected to 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.
Repair and modification
The light source does not contain any user-serviceable parts. Do not disassemble, modify or attempt to
repair it; patient or user injury, equipment damage, and/or the impossibility to obtain the expected
functionality can result. Some problems that appear to be malfunctions may be correctable by referring
to Chapter 8, “Troubleshooting”. If the problem cannot be resolved using the information in Chapter 8,
contact Olympus. The light source is to be repaired by Olympus technicians only.
Signal words
The following signal words are used throughout this manual:
DANGER
Indicates an imminently hazardous situation which, if not avoided, will result in
death or serious injury.
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
6
Indicates additional helpful information.
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Important Information — Please Read Before Use
Dangers, warnings, and cautions
Follow the dangers, warnings, and cautions given below when handling the light source. This
information is to be supplemented by the dangers, warnings, and cautions given in each chapter.
DANGER
• Strictly observe the following precautions. Failure to do so may place the patient
and medical personnel in danger of an electric shock.
When the light source is used to examine a patient, do not allow metal parts of
the endoscope or its accessories to touch metal parts of other system
components. Such contact may cause unintended current flow to the patient.
If fluids are spilled on or into the light source, stop operation of the light source
immediately and contact Olympus.
Do not prepare, inspect, or use the light source with wet hands.
• Never install and operate the light source in the following locations. An explosion or
fire may result because this video system center is not explosion-proof.
The concentration of oxygen is high.
Oxidizing agents (such as nitrous oxide (N2O)) are present in the atmosphere.
Flammable anesthetics are present in the atmosphere.
Flammable liquids are nearby.
WARNING
• In case of light source failure or malfunction, always keep another light source in
the room ready for use.
• Never insert anything into the ventilation grills of the light source. It can cause an
electric shock.
• Do not look directly into the distal end of the endoscope, the distal end of the light
guide cable, or the output socket of the light source when they are emitting light.
The intense light may cause eye injury.
• Do not touch the distal end of the endoscope connector of the endoscope, distal
end of the light guide connector of the endoscope, distal end of the light guide
cable, or output socket of the light source immediately after disconnecting it from
the light source because they are extremely hot. Operator or patient injury can
result.
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Important Information — Please Read Before Use
WARNING
• Although the examination 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 liver tissue and perforation of the intestines
through inappropriate use.
Observe the following warnings about the illumination.
Always set the minimum required brightness. The brightness of the image on a
video monitor may differ from the actual brightness at the distal end of an
endoscope. Especially in combination with endoscopes using an electrical
shutter function, pay attention to the brightness level setting of the light source.
When the light source is used with a video system center compatible with
automatic brightness adjustment function, be sure to use this function. The
automatic brightness adjustment can keep the illumination at a proper level.
Refer to the instruction manual for the video system center for details.
Do not continue observation in the proximity of tissue or keep the distal end of
the endoscope in contact with living tissue for a long time.
When discontinuing the use of the endoscope, be sure to turn the light source
OFF or extinguish the examination lamp by pushing the lamp button.
• Since the light source irradiates strong examination light, the disconnected end of
the light guide cable or the distal end of the endoscope becomes very hot. To
prevent a fire hazard, do not bring the distal end of the light guide cable or the distal
end of the endoscope in contact with a flammable object, such as operating room
drapes while the examination lamp is ON. When no examination is performed, be
sure to turn the light source OFF or extinguish the examination lamp by pushing the
lamp button.
• If the endoscopic image dims during use, blood, mucus, or debris may have soiled
the light guide on the distal end of the endoscope. Carefully withdraw the
endoscope from the patient and remove the blood or mucus to obtain optimum
illumination and to ensure the safety of the examination. If you continue to use the
endoscope in such a condition, the distal end temperature may rise and cause
mucosal burns. It may also cause patient and/or operator injury.
• The light source may interfere with other medical electronic equipment used in
combination with it. Before use, refer to the Appendix to confirm the compatibility of
the light source with all equipment to be used.
• Do not use the light source in locations exposed to strong electromagnetic radiation
(e.g., in the vicinity of a microwave therapeutic device, MRI, short-wave therapeutic
device, radio equipment, or cellular/portable phone). This may impair the
performance of the light source.
• Do not touch the output connector of the light source. Operator or patient injury can
result.
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Important Information — Please Read Before Use
WARNING
• Do not connect any object other than the light guide and an endoscope to the
output connector. Otherwise, malfunction may result.
• Do not rely on the optical-digital observation mode alone for primary detection of
lesions or for a decision regarding any potential diagnostic or therapeutic
intervention.
CAUTION
• Do not use a pointed or hard object to press the buttons on the front panel. This
may damage the buttons.
• Do not touch the electrical contacts inside the light source’s connectors.
• Do not apply excessive force to the light source and/or other instruments
connected. Otherwise, damage and/or malfunction can occur.
• Do not leave the examination lamp ON when an endoscope is connected to the
light source. The examination light reaches the maximum intensity and the
endoscope’s distal end becomes hot. In addition, smoke may also be produced if
the debris attached to the distal end is heated.
• If the emergency lamp, instead of the examination lamp, lights up frequently when
pressing the lamp button to light the examination lamp, the light source may have
already malfunctioned. Return the light source for repair, following Section 8.3,
“Returning the light source for repair”.
• Avoid using the light source in a dusty environment. This may damage the light
source.
• Be sure that the light source is not used adjacent to or stacked with other
equipment (other than the components of the light source or system) to avoid
electromagnetic interference.
• Electromagnetic interference may occur on the light source 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 the light source, or shielding the location.
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Important Information — Please Read Before Use
NOTE
As defined by the international safety standard (IEC 60601-1), medical electrical
equipment is classified into the following types: TYPE CF applied part (the
instrument can safely be applied to any part of the body, including the heart), and
TYPE B/BF applied part (the instrument can safely be applied to any organ except
the heart). The part of the body that an endoscope or electrosurgical accessory can
safely be applied to depends on the classification of the equipment to which the
instruments are connected. Before beginning the procedure, check the current
leakage classification type of each instrument to be used for the procedure.
Classification types are clearly specified in the instruments’ instruction manuals.
Symbol
Classification
TYPE CF applied part
TYPE BF applied part
TYPE B applied part
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Important Information — Please Read Before Use
Cardiac applications
DANGER
• Use only the devices listed in the “ System chart” on page 103 for endoscopic
observation or treatment of the heart or areas near the heart. Other combinations
of equipment may cause ventricular fibrillation or seriously affect the cardiac
function of the patient.
• For cardiac applications, never support the endoscope with a metal surgical arm
that is not electrically isolated from the ground. If not isolated, the endoscope will
be connected to the ground through the surgical arm and bed, and will conduct
unexpected leakage current that may seriously affect the cardiac function of the
patient.
• The use of medical devices not specifically designed for cardiac applications may
cause ventricular fibrillation or seriously affect the cardiac function of the patient. As
specified by the international standard IEC 60601-1, any applied part used for
observation or treatment of the heart or areas near the heart must meet “TYPE CF
applied part” requirements for low electrical leakage current. When using
endoscopes for endoscopic cardiac applications, the applied part requirements
include all devices directly connected to the endoscope, such as the light guide
cable, camera head, and telescope holder. Each of these devices must individually
meet the “TYPE CF applied part” requirements for leakage current limits if they are
to be used for cardiac applications.
NOTE
• The OLYMPUS light guide cables and camera heads listed in the “ System chart”
on page 103 (TYPE CF applied part) that are suitable for cardiac applications bear
a
mark.
• The Olympus Surgical Holder for Telescope (SH-1) has an electrically isolated arm
structure that isolates the endoscope from the ground. This design makes the SH-1
suitable for cardiac applications.
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Summary of the Equipment Functions
Summary of the Equipment Functions
Some of the functions described below may be unavailable or restricted depending on the combined
equipment. For more details, refer to the instruction manuals for the light source and the required
ancillary equipment.
Providing the examination light
The light of the examination lamp built into the light source is provided to the endoscope.
Section 5.3, “Turning the light source ON and igniting the examination lamp”
Adjusting the examination light
When the light source is used in combination with the video system center, a videoscope, and
camera head, the examination light intensity is adjusted automatically. When the light source is
used in combination with a fiber endoscope, the examination light intensity has to be adjusted
manually.
Section 5.5, “Brightness adjustment”
Optical-digital observation
NBI observation is available as an optical-digital observation mode.
Section 5.6, “Optical-digital observation”
Transillumination function
The endoscope’s distal end emits the intense light. The light transmits the patient’s body wall so
that the operator can confirm the position of the distal end from outside the patient’s body
provided that the operating room illumination is low.
Section 5.7, “Transillumination function”
Selecting the high intensity mode
Brighter examination light is available when using an endoscope and light guide that are
compatible with high intensity mode operation.
Section 5.8, “High intensity mode”
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Summary of the Equipment Functions
Air and water feed
The light source incorporates an air pump and an external water feed tank to feed air and water
from the nozzle at the endoscope’s distal end into the body cavity, and the air/water flow can be
adjusted.
Section 5.9, “Air/water feeding”
Monitoring the operating hours of the examination lamp
The lamp usage indicator on the front panel of the light source displays the total accumulated
operation hours of the examination lamp to indicate the time for replacement.
Section 4.6, “Checking the lamp usage indicator”
Automatic switching to the emergency lamp
If the examination lamp does not light up or blows in the middle of an examination making
endoscopic observation impossible, the light source switches automatically to the emergency
light. The emergency light provides enough brightness for withdrawing the endoscope from the
patient’s body.
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Summary of the Equipment Functions
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1.1 Checking the package contents list
Chapter 1
1.1
Checking the Package
Contents
Checking the package contents list
Match all items in the package with the components shown below. Inspect each item for damage. If the
light source is damaged, a component is missing, or you have any questions, do not use the light
source and immediately contact Olympus.
Light source
EVIS EXERA III xenon light source (CLV-190)
Accessories
Digital light source cable
(MAJ-1933)
Light source cable (MAJ-1941)
Foot holders (MAJ-1205, 4 pcs.)
Power cord
Water container (MAJ-901)
Instruction manual
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Ch.1
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1.1 Checking the package contents list
Ch.1
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2.1 Nomenclature and functions
Chapter 2
2.1
Nomenclature and
Functions
Nomenclature and functions
Front panel
Symbol
Description
Symbol
Description
Ch.2
Power ON/OFF
Brightness
Decrease brightness
Increase brightness
Exchange lamp
(Lamp usage indicator)
Lamp usage indicator reset
New lamp
(Lamp usage indicator)
Emergency lamp
Examination lamp ignition
Mode select
Transillumination
High intensity mode
Air-feeding
Air pressure control
Air pressure low
Air pressure medium
Air pressure high
Observation mode
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2.1 Nomenclature and functions
Rear and side panels
Symbol
Description
Description
Refer to instructions.
Warns that the lamp is hot.
Serial number
Potential equalization
terminal
Alternating current
Caution
Ch.2
18
Symbol
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2.2 Front panel
2.2
Front panel
2
3
Ch.2
4
1
No.
Nomenclature
Description
1
Power switch
Press to turn the light source ON or OFF.
2
Power indicator
Lights up when the light source is ON.
3
Output socket
Connects the endoscope or the light guide cable to this socket.
This socket provides light and air to the endoscope.
4
Control panel
Refer to the next page.
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2.2 Front panel
Control panel (buttons)
7
5
6
8
9
10
11
Ch.2
13
14
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