clv-s400_visera_4k_uhd_xenon_light_source_instructi.pdf
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INSTRUCTIONS
VISERA 4K UHD XENON LIGHT SOURCE
Labels and Symbols
1
Important Information — Please Read Before
Use
3
Summary of the Equipment Functions
9
OLYMPUS CLV-S400
Chapter 1
Checking the Package Contents
11
Chapter 2
Nomenclature and Functions
13
Chapter 3
Installation and Connection
21
Chapter 4
Inspection
29
Chapter 5
Operation
49
Chapter 6
Lamp Replacement
63
Chapter 7
Care, Storage, and Disposal
75
Chapter 8
Troubleshooting
79
Appendix
USA: CAUTION: Federal law restricts this device to sale by or on the order of a physician.
85
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Contents
Contents
Labels and Symbols .......................................................................................................... 1
Important Information — Please Read Before Use ......................................................... 3
Intended use ..........................................................................................................................
Contraindications ...................................................................................................................
Applicability of endoscopy and endoscopic treatment ...........................................................
Instruction manual .................................................................................................................
User qualifications .................................................................................................................
Instrument compatibility .........................................................................................................
Repair and modification .........................................................................................................
Signal words ..........................................................................................................................
Precautions ............................................................................................................................
3
3
3
4
5
5
5
6
6
Summary of the Equipment Functions ............................................................................ 9
Chapter 1 Checking the Package Contents ....................................... 11
1.1
Checking the package contents list ..................................................................... 11
Chapter 2 Nomenclature and Functions ............................................ 13
2.1
Nomenclature and functions ................................................................................. 13
2.2
Front panel .............................................................................................................. 15
2.3
Rear panel ............................................................................................................... 18
2.4
Side panel ................................................................................................................ 19
Chapter 3 Installation and Connection ............................................... 21
3.1
Precaution for installation and connection .......................................................... 21
3.2
Installation workflow .............................................................................................. 22
3.3
Installation of equipment ....................................................................................... 23
Installation on the mobile workstation (WM-NP2) ................................................................ 24
Installation in another location ............................................................................................. 25
3.4
Connection of the camera control unit ................................................................ 26
3.5
Connection to the AC mains power supply ......................................................... 27
Chapter 4 Inspection ............................................................................ 29
4.1
Warnings: inspection ............................................................................................. 29
4.2
Inspection workflow ............................................................................................... 30
4.3
Connection of an endoscope ................................................................................ 31
4.4
Inspection of power ON ......................................................................................... 32
4.5
Inspection of the lamp usage indicator ................................................................ 35
4.6
Inspection of the examination light ...................................................................... 36
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Contents
4.7
Inspection of the brightness mode selection ...................................................... 38
4.8
Inspection of brightness adjustment .................................................................... 39
Inspection of automatic brightness adjustment ................................................................... 39
Inspection of manual brightness adjustment ....................................................................... 42
4.9
Inspection of the NBI observation ........................................................................ 44
4.10 Inspection of the high intensity mode .................................................................. 45
4.11 After inspection ...................................................................................................... 47
Chapter 5 Operation ............................................................................. 49
5.1
Warnings: operation ............................................................................................... 49
5.2
Operation workflow ................................................................................................ 52
5.3
Turning ON the light source and igniting the examination lamp ....................... 53
5.4
Setting the brightness mode ................................................................................. 54
5.5
Adjusting the brightness ....................................................................................... 55
Automatic brightness adjustment ........................................................................................ 55
Manual brightness adjustment ............................................................................................. 57
5.6
Using the NBI observation ..................................................................................... 58
5.7
Using the high intensity mode .............................................................................. 59
5.8
Extinguishing the examination lamp .................................................................... 60
5.9
Turn OFF the light source ...................................................................................... 61
Chapter 6 Lamp Replacement ............................................................. 63
6.1
Replacement of the examination (xenon) lamp ................................................... 63
6.2
Removal of the lamp .............................................................................................. 64
6.3
Insertion of the lamp .............................................................................................. 67
6.4
Lamp usage indicator reset ................................................................................... 72
Chapter 7 Care, Storage, and Disposal .............................................. 75
7.1
Care .......................................................................................................................... 75
7.2
Storage .................................................................................................................... 77
7.3
Disposal ................................................................................................................... 78
Examination lamp ................................................................................................................ 78
The light source or any of its components ........................................................................... 78
Chapter 8 Troubleshooting .................................................................. 79
ii
8.1
Troubleshooting ..................................................................................................... 79
8.2
Troubleshooting guide ........................................................................................... 80
8.3
Returning the light source for repair .................................................................... 83
CLV-S400 INSTRUCTION MANUAL
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Contents
Appendix ................................................................................................. 85
Combination equipment .................................................................................................. 85
System chart ........................................................................................................................ 85
Specifications .................................................................................................................. 87
Environments ....................................................................................................................... 87
Specifications ....................................................................................................................... 88
EMC information .............................................................................................................. 90
License information of Open Source Software ............................................................. 95
GNU GPL ............................................................................................................................
End User License Agreement of Open Source Software modules ......................................
Others ..................................................................................................................................
newlib ..................................................................................................................................
CLV-S400 INSTRUCTION MANUAL
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95
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Contents
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CLV-S400 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
Product name
CE marking
VISERA 4K UHD
XENON LIGHT SOURCE
MODEL OLYMPUS CLV-S400
Potential equalization terminal
Cautions that the
inside is extremely hot
immediately after the
lamp is extinguished.
Indicates to refer to the
instruction manual for the cable
to be connected.
Blue
Indicates to refer to
the instruction manual
for replacement of the
examination lamp.
Lamp model number
Crossed-out wheeled bin’ symbol
Serial number plate
Manufacturer name
Electrical rating
POWER INPUT 100 – 240V
50/60Hz 500VA
CLV-S400 INSTRUCTION MANUAL
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Labels and Symbols
Front panel
TYPE BF applied part
Back cover of this instruction manual
Symbol
Description
Manufacturer
Authorized representative in the European Community
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CLV-S400 INSTRUCTION MANUAL
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Important Information — Please Read Before Use
Important Information — Please Read Before Use
Intended use
The light source has been designed to be used with Olympus endoscopes, camera control unit, light
guide cables, and other ancillary equipment for endoscopic diagnosis, treatment, and observation.
Contraindications
As a TYPE BF applied part, this light source must never be applied directly to the heart and must not
be used in procedures involving cardiac observation or surgery. Leakage current from the TYPE BF
applied part may be dangerous and cause ventricular fibrillation or seriously affect the cardiac function
of the patient. Accordingly, always adhere to the following points:
Never apply the endoscope connected to this light source to the heart or any area near the
heart.
Never allow an EndoTherapy accessory or another endoscope applied to or near the heart
to come in contact with an endoscope connected to this light source.
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.
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Important Information — Please Read Before Use
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 for 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, contact Olympus.
Terms used in this manual
Camera control unit:
The camera control unit is a device that receives the electrical signals from a camera
head and displays the endoscopic images on the monitor.
Camera head:
The camera head is a device that converts endoscopic images taken by an endoscope
into electrical signals.
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 an 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.
High intensity mode:
This mode emits brighter illumination light than usual. It is available with only the light
guide cable is compatible with this mode.
WLI (White Light Imaging) observation:
This observation uses white light.
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Important Information — Please Read Before Use
NBI (Narrow Band Imaging) observation:
This is observation using narrowband 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 light source 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” on page 85 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 light source complies with the EMC standard for medical electrical equipment, edition 3
(IEC 60601-1-2: 2007) and edition 2 (IEC 60601-1-2: 2001). 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 the light source; 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.
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Important Information — Please Read Before Use
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.
Precautions
Follow the warnings and cautions given below when handling the light source. This information is to be
supplemented by the warnings and cautions given in each chapter.
WARNING
• Strictly observe the following warnings. 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 the light source 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.
• Be sure to prepare spare equipment to avoid interruption of the examination due to
equipment failure or malfunction.
• Never insert anything into the ventilation grills of the light source. It can cause an
electric shock.
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Important Information — Please Read Before Use
WARNING
• 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 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.
• 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
monitor may differ from the actual brightness at the distal end of an endoscope.
Especially in combination with endoscopes using an electronic shutter function,
pay attention to the brightness setting of the light source. When the light source
is used with a camera control unit 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 camera control unit 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 disconnected end of the light guide cable or
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.
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Important Information — Please Read Before Use
WARNING
• 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 rely on the NBI observation mode alone for primary detection of lesions or
for a decision regarding any potential diagnostic or therapeutic intervention.
• When disconnecting the camera head from the endoscope with the examination
lamp ON, set the brightness mode to “MANU” and set the examination light
intensity to the minimum level. If the camera head is disconnected while the
brightness mode is “AUTO”, the intense light may injure your eyes.
CAUTION
• Do not connect any object other than a light guide cable to the output socket.
Malfunction may result.
• Do not use a pointed or hard object to press the buttons on the front panel. This
may damage the buttons.
• Do not apply excessive force to the light source and/or other instruments
connected. 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 this instrument is not used adjacent to or stacked with other equipment
(other than the components of this instrument or system) to avoid electromagnetic
interference.
• Electromagnetic interference may occur on this instrument 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 instrument, or shielding the location.
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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 ON the light source and igniting the examination lamp”
Adjusting the examination light
When the light source is used in combination with the camera control unit and camera head, the
examination light intensity is adjusted automatically.
Section 5.5, “Adjusting the brightness”
Selecting the NBI observation mode
NBI observation is available.
Section 5.6, “Using the NBI observation”
Selecting the high intensity mode
Brighter examination light is available when using a light guide cable that is compatible with high
intensity mode operation.
Section 5.7, “Using the high intensity mode”
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 4.5, “Inspection of 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 component packaging 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
VISERA 4K UHD xenon light source (CLV-S400)
Accessories
Light source cable (MAJ-1941)
Foot holders (MAJ-1205, 4 pcs.)
Power cord
Instruction manual
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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
Power ON/OFF
Brightness
Decrease brightness
Increase brightness
Exchange lamp
(Lamp usage indicator)
Counter reset
(Lamp usage indicator
reset)
New lamp
(Lamp usage indicator)
Spare lamp
(Emergency lamp)
Examination lamp ignition
Mode select
High intensity mode
Observation mode
Ch.2
TYPE BF applied part
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2.1 Nomenclature and functions
Rar and side panels
Symbol
Description
Warns that the lamp is hot.
Serial number
Potential equalization
terminal
Lamp model number
14
Description
Refer to instructions.
Alternating current
Ch.2
Symbol
CLV-S400 INSTRUCTION MANUAL
Blue
Refer to instructions
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2.2 Front panel
2.2
Front panel
2
1
4
3
Ch.2
5
No.
5
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
Connect the light guide cable to this socket.
This socket provides the endoscope with light.
4
Control panel
Refer to the next page.
5
Foot
Fit the Feet into the foot holders.
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2.2 Front panel
Control panel (buttons)
1
2
3
Ch.2
6
No.
Nomenclature
4
5
Description
1
Observation mode
button
Press to switch the observation modes.
Section 5.6, “Using the NBI observation”
2
Intensity mode
button
Press this button to switch between the high intensity mode and normal intensity mode.
Section 5.7, “Using the high intensity mode”
3
Lamp button
Press to turn ON the examination lamp. Press for a longer period while the lamp is ON
to turn it OFF.
Section 5.3, “Turning ON the light source and igniting the examination lamp”
Section 5.8, “Extinguishing the examination lamp”
4
Brightness buttons
Press these buttons to adjust the brightness.
Section 5.5, “Adjusting the brightness”
5
Brightness mode
button
Press this button to select automatic or manual brightness adjustment.
Section 5.4, “Setting the brightness mode”
6
Counter reset
button
Press this button for at least 3 seconds to reset the lamp usage indicator after replacing
the examination lamp.
Section 6.4, “Lamp usage indicator reset”
NOTE
Each button on the front panel is active only when it is lighting up. When it is not
lighting up, the camera control unit does not work even if the button is pressed.
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2.2 Front panel
Control panel (indicators)
2
1
3
7
4
6
No.
Nomenclature
Ch.2
5
Description
1
Observation mode
indicators
These indicators display whether the observation mode is NBI (“ON”) or WLI (“STBY”).
Section 5.6, “Using the NBI observation”
2
High intensity mode This indicator lights up when the high intensity mode is selected.
indicator
Section 5.7, “Using the high intensity mode”
3
Lamp indicators
4
Brightness indicator These indicators display the current brightness.
Section 5.5, “Adjusting the brightness”
5
Emergency lamp
indicator
This indicator lights up when the emergency lamp (halogen) is in use. It blinks when the
emergency lamp (halogen) is broken, disconnected, or not mounted.
Section 4.4, “Inspection of power ON”
Section 4.6, “Inspection of the examination light”
6
Lamp usage
indicator
This indicator displays the total working hours of the examination (xenon) lamp.
Section 4.5, “Inspection of the lamp usage indicator”
7
Brightness mode
indicators
These indicators display the brightness adjustment setting (“AUTO” or “MANU”).
Section 5.4, “Setting the brightness mode”
These indicators display whether the examination lamp (xenon lamp) lights up (“ON”) or
not (“STBY”).
Section 5.3, “Turning ON the light source and igniting the examination lamp”
Section 5.8, “Extinguishing the examination lamp”
NOTE
When the light source is turned ON with no light guide cables connected to the light
source, the lamp indicator “STBY” may blink.
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2.3 Rear panel
2.3
Rear panel
1
2
3
Ch.2
4
No.
5
6
Nomenclature
4
Description
1
OTV terminal
2
LINK-OUT terminal Reserved for future system expansion.
3
Potential
equalization
terminal
This terminal is connected to a potential equalization terminal of the other equipment
connected to the light source. The electrical potential of the equipment is equalized.
4
Foot
Fit the Feet into the foot holders.
5
Ventilation grills
Prevent the internal temperature of the light source from rising by ventilation.
6
AC power inlet
Connect the provided power cord to supply the AC power via this inlet.
Section 3.5, “Connection to the AC mains power supply”
18
This terminal is the receptacle for the light source cable (MAJ-1941) for use with the
camera control unit.
Section 3.4, “Connection of the camera control unit”
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2.4 Side panel
2.4
Side panel
2
1
Ch.2
3
No.
Nomenclature
Description
1
Lamp cover
This cover has to be removed to replace the examination lamp.
Chapter 6, “Lamp Replacement”
2
Lamp chamber
The lamp is inserted to this chamber.
Chapter 6, “Lamp Replacement”
3
Ventilation grills
Prevent the internal temperature of the light source from rising by ventilation.
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2.4 Side panel
Ch.2
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