clv-260sl_evis_lucera_xenon_light_source_instructio.pdf
Page 1
INSTRUCTIONS
EVIS LUCERA XENON LIGHT SOURCE
OLYMPUS CLV-260SL
Page 3
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 ...........................................................................
5
Repair and modification ...........................................................................
5
Signal words..............................................................................................
6
Dangers, warnings and cautions...............................................................
7
Summary of the Functions of the Instrument ............................
11
Chapter 1
Checking the Package Contents............................
13
Chapter 2
Nomenclature and Functions .................................
14
2.1
Symbols and descriptions ...............................................................
14
2.2
Front panel......................................................................................
16
2.3
Rear and side panels ......................................................................
19
Inspection ................................................................
21
3.1
Inspection work flow........................................................................
22
3.2
Inspection of the power supply .......................................................
23
3.3
Checking the lamp hour indicator ...................................................
25
3.4
Inspection of the examination light..................................................
26
3.5
Inspecting the system mode switching function..............................
28
3.6
Inspection of brightness adjustment ...............................................
29
3.7
Inspection of the special light observation ......................................
32
3.8
Inspection of transillumination function ...........................................
34
3.9
Inspection of air and water feeding .................................................
36
3.10 After inspection ...............................................................................
38
Chapter 3
EVIS LUCERA XENON LIGHT SOURCE CLV-260SL
i
Page 4
Contents
Chapter 4
Operation..................................................................
39
4.1
Operation flow .................................................................................
41
4.2
Connection of an endoscope ..........................................................
43
4.3
Turning the light source ON and igniting the examination lamp......
44
4.4
Setting the system mode ................................................................
45
4.5
Brightness adjustment ....................................................................
46
4.6
Special light observation .................................................................
48
4.7
Transillumination function ...............................................................
50
4.8
Adjusting air/water pressure............................................................
51
4.9
Extinguishing the examination lamp................................................
52
4.10 Turning the light source OFF ..........................................................
53
Chapter 5
Lamp and Fuse Replacement .................................
54
5.1
Replacement of the examination (xenon) lamp...............................
54
5.2
Fuse replacement ...........................................................................
64
Care, Storage and Disposal ....................................
66
6.1
Care ................................................................................................
66
6.2
Storage ...........................................................................................
67
6.3
Disposal ..........................................................................................
67
Installation and Connection....................................
68
7.1
Installation work flow .......................................................................
69
7.2
Installation of equipment .................................................................
70
7.3
Installation of the water container ...................................................
73
7.4
Connection of the video system center ...........................................
74
7.5
Connection to the AC mains power supply .....................................
76
Troubleshooting ......................................................
78
8.1
Troubleshooting guide ....................................................................
78
8.2
Returning the light source for repair................................................
84
Appendix........................................................................................
85
System chart ............................................................................................
85
Transportation, storage and operating environments................................
88
Specifications ...........................................................................................
88
EMC information........................................................................................
91
Chapter 6
Chapter 7
Chapter 8
ii
EVIS LUCERA XENON LIGHT SOURCE CLV-260SL
Page 5
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 side
Electrical rating
The product name, rated voltage and
frequency are shown.
CE marking
Potential equalization
terminal
Cautions that only the exclusive
cable can be connected.
Fuse rating
Serial number plate
Manufacturer name
Cautions that the inside is
extremely hot immediately
after the lamp is extinguished.
Crossed-out wheeled bin’ symbol
Caution on lamp replacement
EVIS LUCERA XENON LIGHT SOURCE CLV-260SL
1
Page 6
Labels and Symbols
Back cover of this instruction manual
Manufacturer
Authorised representative in the European Community
2
EVIS LUCERA XENON LIGHT SOURCE CLV-260SL
Page 7
Important Information — Please Read Before Use
Important Information — Please Read
Before Use
Intended use
This light source has been designed to be used with Olympus endoscopes and
ancillary equipment for observation, diagnosis and endoscopic treatment.
Do not use this light source for any purpose other than its intended use.
Applicability of endoscopy and endoscopic treatment
If there is an official standard on the applicability of endoscopy and endoscopic
treatment that is defined by the hospital’s administration or other official
institutions such as academic societies on endoscopy, follow that standard.
Before starting endoscopy and endoscopic treatment, thoroughly evaluate its
properties, purposes, effects, and possible risk (their natures, extent and
probability). Perform endoscopy and endoscopic treatment only when its
potential benefits are greater than its risks.
Fully explain to the patient the potential benefits and risks of the endoscopy and
endoscopic treatment as well as any examination/treatment methods that can be
performed in its place, and perform the endoscopy and endoscopic treatment
only after obtaining the consent of the patient.
Even after starting the endoscopy and endoscopic treatment, continue to
evaluate the potential benefits and risks, and immediately stop the
endoscopy/treatment and take proper measures if the risks to the patient
become greater than the potential benefits.
Instruction manual
This instruction manual contains essential information on using this light source
safely and effectively. Before use, thoroughly review this manual and the
manuals of all equipment which will be used during the procedure and use the
equipment as instructed.
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.
EVIS LUCERA XENON LIGHT SOURCE CLV-260SL
3
Page 8
Important Information — Please Read Before Use
Terms used in this manual
EVIS LUCERA video system center:
The EVIS LUCERA video system center is a device that converts signals
from a videoscope or OES video converter into monitor images.
OES video converter:
The OES video converter is a device that converts endoscopic images
from a fiberscope into monitor images.
Wall mains outlet:
The wall mains outlet is a wall AC mains power outlet socket having the
exclusive terminal for grounding.
Automatic brightness control:
The automatic brightness control 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. This
function is available only with EVIS videoscopes and a few fiberscopes.
Special light observation:
This is an observation using specific filtered light.
AFI (Auto-Fluorescence Imaging) observation:
This is a special light observation using the blue light.
NBI (Narrow Band Imaging) observation:
This is a special light observation using the narrow band observation light.
IRI (Infra-Red Imaging) observation:
This is a special light observation using the infra-red observation light.
Normal light observation (WLI (White Light Imaging) observation):
This is the ordinary observation using the RGB light.
4
EVIS LUCERA XENON LIGHT SOURCE CLV-260SL
Page 9
Important Information — Please Read Before Use
User qualifications
If there is an official standard on user qualifications to perform endoscopy and
endoscopic treatment that is defined by the medical administration or other
official institutions, such as academic societies on endoscopy, follow that
standard. If there is no official qualification standard, the operator of this
instrument must be a physician approved by the medical safety manager of the
hospital or person in charge of the department (department of internal medicine,
etc.).
The physician should be capable of safely performing the planned endoscopy
and endoscopic treatment following guidelines set by the academic societies on
endoscopy, etc., and considering the difficulty of endoscopy and endoscopic
treatment. This manual does not explain or discuss endoscopic procedures.
Instrument compatibility
Refer to the “System chart” in the Appendix to confirm that this 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). However, when connecting 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
This light source does not contain any user-serviceable parts. Do not
disassemble, modify or attempt to repair it; patient or user injury and/or
equipment damage 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.
EVIS LUCERA XENON LIGHT SOURCE CLV-260SL
5
Page 10
Important Information — Please Read Before Use
Signal words
The following signal words are used throughout this manual:
Indicates an imminently hazardous situation which, if not
avoided, will result in death or serious injury.
Indicates a potentially hazardous situation which, if not
avoided, could result in death or serious injury.
Indicates a potentially hazardous situation which, if not
avoided, may result in minor or moderate injury. It may also
be used to alert against unsafe practices or potential
equipment damage.
Indicates additional helpful information.
6
EVIS LUCERA XENON LIGHT SOURCE CLV-260SL
Page 11
Important Information — Please Read Before Use
Dangers, warnings and cautions
Follow the dangers, warnings and cautions given below when handling this light
source. This information is to be supplemented by the dangers, warnings and
cautions given in each chapter.
•
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 otherwise
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 endo-therapy accessory or another
endoscope applied to or near the heart to come in contact
with an endoscope connected to this light source.
•
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.
−
Keep liquids away from all electrical equipment. If fluids
are spilled on or into the unit, stop operation of the light
source at once and contact Olympus.
− Do not prepare, inspect or use this light source with wet
hands.
•
Never install and operate the light source in locations where:
− 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.
Otherwise, explosion or fire may result because this light
source is not explosion-proof.
EVIS LUCERA XENON LIGHT SOURCE CLV-260SL
7
Page 12
Important Information — Please Read Before Use
8
•
In case of instrument 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 and/or fire.
•
Do not look directly into the distal end of the endoscope or
the output socket of the light source when they are emitting
light. The intense light may cause eye injury.
In the IRI observation mode, the examination light includes
invisible near-infrared light. The intensity can be quite high
although the brightness looks low, which may cause patient
injury.
•
Do not touch the distal end of the light guide or the output
connector of this instrument immediately after disconnecting
the light guide from this instrument, because they are
extremely hot. Operator or patient injury can result.
•
As this instrument emits strong examination light, the distal
end becomes very hot. To prevent a fire hazard, do not bring
the endoscope’s distal end in contact with a flammable object
such as a cloth during examination lamp output. When no
examination is performed, be sure to turn this instrument
OFF or extinguish the examination lamp.
•
This product may interfere with other medical electronic
equipment used in combination with it. Before use, refer to
the Appendix to confirm the compatibility of this instrument
with all equipment to be used.
•
Do not use this product in any place where it may be subject
to strong electromagnetic radiation (for example, in the
vicinity of a microwave therapeutic device, MRI, wireless set,
short-wave therapeutic device, cellular/portable phone, etc.).
This may impair the performance of the product.
•
Do not rely on the special light observation method alone for
primary detection of lesions or for a decision regarding any
potential diagnostic or therapeutic intervention.
EVIS LUCERA XENON LIGHT SOURCE CLV-260SL
Page 13
Important Information — Please Read Before Use
•
Do not use a pointed or hard object to press the buttons on
the front panel. This may damage the buttons.
•
To avoid damaging electrical contacts and causing a
malfunction, always adhere to the following points:
− Do not touch the electrical contacts of the output socket of
this instrument.
− Do not subject any connector to excessive force.
•
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.
•
Avoid using this instrument in a dusty environment, as this
may damage the instrument.
•
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.
EVIS LUCERA XENON LIGHT SOURCE CLV-260SL
9
Page 14
Important Information — Please Read Before Use
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
10
EVIS LUCERA XENON LIGHT SOURCE CLV-260SL
Page 15
Summary of the Functions of the Instrument
Summary of the Functions of the
Instrument
Some of the functions described below may be unavailable or restricted
depending on the combined equipment. Refer to the instruction manuals for the
light source and the required ancillary equipment for details.
Illuminating the operation
The light of the examination lamp built into this instrument is provided to the
endoscope.
→ Section 4.3, “Turning the light source ON and igniting the examination
lamp” on page 44
Adjusting the examination light
When this instrument is used in combination with the EVIS LUCERA video
system center and a videoscope, the examination light intensity is adjusted
automatically. When this instrument is used in combination with a fiberscope, the
examination light intensity has to be adjusted manually.
→ Section 4.5, “Brightness adjustment” on page 46
Special light observation
AFI observation, NBI observation and IRI observation are available.
→ Section 4.6, “Special light observation” on page 48
Air and water feed
This instrument incorporates an air pump and exclusive water feed tank for use
in feeding air and water from the nozzle at the endoscope’s distal end to the
body cavity and adjusting the air/water flow.
→ Section 4.8, “Adjusting air/water pressure” on page 51
EVIS LUCERA XENON LIGHT SOURCE CLV-260SL
11
Page 16
Summary of the Functions of the Instrument
Transillumination function
The endoscope’s distal end emits the intense light. The light transmits the
patient’s body wall so 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 4.7, “Transillumination function” on page 50
Monitoring the operating hours of examination lamp
The lamp hour indicator on the front panel of this instrument displays the total
accumulated operating hours of the examination lamp to indicate the time for
replacement.
→ Section 3.3, “Checking the lamp hour indicator” on page 25
Automatic switching to emergency lamp
If the examination lamp does not light 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.
→ “If the emergency lamp indicator lights up” on page 27
12
EVIS LUCERA XENON LIGHT SOURCE CLV-260SL
Page 17
Chapter 1 Checking the Package Contents
Chapter 1 Checking the Package
Contents
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; immediately contact Olympus.
EVIS LUCERA xenon light source
(CLV-260SL)
Light control cable
(MAJ-1530)
Foot holders
(MAJ-1205, 4 pcs.)
Spare fuses
(MAJ-1412, 2 pcs.)
Power cord
Instruction manual
EVIS LUCERA XENON LIGHT SOURCE CLV-260SL
13
Page 18
Chapter 2 Nomenclature and Functions
Chapter 2 Nomenclature and Functions
2.1
Symbols and descriptions
Front panel
Power ON/OFF
Special observation
mode
Filter mode
Transillumination
Air feeding
Air pressure control
Air pressure low
Air pressure medium
Air pressure high
Lamp hour indicator
reset
New lamp
(Lamp hour indicator)
Exchange lamp
(Lamp hour indicator)
Examination lamp
ignition
Automatic brightness
adjustment
Manual brightness
adjustment
Brightness up
Brightness down
Brightness
Emergency lamp
14
EVIS LUCERA XENON LIGHT SOURCE CLV-260SL
Page 19
Chapter 2 Nomenclature and Functions
Rear and side panels
Refer to instructions.
Warns that the lamp is
hot.
Fuse
Potential equalization
terminal
Serial number
Alternating current
EVIS LUCERA XENON LIGHT SOURCE CLV-260SL
15
Page 20
Chapter 2 Nomenclature and Functions
2.2
Front panel
Front panel
2. Power indicator
1. Power switch
3. Output socket
Control panel
Control panel (buttons and indicators)
8. Airflow regulator
indicators
7. Airflow regulator
button
6. Airflow indicator
13. System mode indicators
12. EVIS/OES button
11. Brightness level indicator
10. Brightness adjustment buttons
9. Emergency
lamp indicator
5. Airflow button
4. Transillumination
button
22. Counter reset
button
21. Lamp hour
indicator
20. Special light indicator
19. Special light button
18. Special light mode
selection indicators
15. Lamp ON
indicator
14. Lamp button
16. Special light mode button
17. Special light mode indicators
16
EVIS LUCERA XENON LIGHT SOURCE CLV-260SL
Page 21
Chapter 2 Nomenclature and Functions
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
This socket provides light and air to the endoscope.
4. Transillumination button
When pressing this button, light emitted from the distal end of the
endoscope becomes brighter for 7 seconds, then returns automatically to its
original brightness level.
→ Section 4.7, “Transillumination function” on page 50
5. Airflow button
Pressing this button starts and stops air feeding from the endoscope’s distal
end.
→ Section 4.8, “Adjusting air/water pressure” on page 51
6. Airflow indicator
This indicator is lit only when the airflow switch is ON.
7. Airflow regulator button
This button is used to control the air being fed from the endoscope.
→ Section 4.8, “Adjusting air/water pressure” on page 51
8. Airflow regulator indicators
These indicators display the current airflow pressure level setting (Low,
Medium or High).
9. Emergency lamp indicator
This indicator lights when the emergency lamp (halogen) is in use, and
blinks when the emergency lamp (halogen) is disconnected or not mounted.
10. Brightness adjustment buttons
These buttons are pressed to adjust the brightness level.
→ Section 4.5, “Brightness adjustment” on page 46
11. Brightness level indicator
These indicators display the current brightness level.
12. EVIS/OES button
This button is pressed to change the system mode of the light source.
→ Section 4.4, “Setting the system mode” on page 45
13. System mode indicators
This indicator shows the current system mode of the light source.
14. Lamp button
This button is pressed to turn ON or OFF the examination (xenon) lamp.
EVIS LUCERA XENON LIGHT SOURCE CLV-260SL
17
Page 22
Chapter 2 Nomenclature and Functions
15. Lamp ON indicator
This indicator lights when the examination lamp is lit.
16. Special light mode button
Press to select the special light observation.
→ Section 4.6, “Special light observation” on page 48
17. Special light mode indicators
These indicators display the special light observations available with the
connected endoscope.
18. Special light mode selection indicators
One of these indicators lights up and indicates the special light observation
being selected.
19. Special light button
Press to switch the observation alternately between normal light observation
and special light observation.
→ Section 4.6, “Special light observation” on page 48
20. Special light indicator
The indicator lights in the special light observation.
21. Lamp hour indicator
This indicator displays the total operating hours of the examination lamp.
22. Counter reset button
After replacing the examination lamp, the lamp hour indicator is reset by
pressing this button for at least 3 seconds.
→ “Lamp hour indicator reset” on page 62
All buttons (except the counter reset button) can only be
used, when the button lights. Otherwise, the buttons are not
active.
18
EVIS LUCERA XENON LIGHT SOURCE CLV-260SL
Page 23
Chapter 2 Nomenclature and Functions
2.3
Rear and side panels
4. Potential
equalization
terminal
3. CV terminal
5. Water container holder
2. Fuse box
Rear foot
1. AC power inlet
Rear panel
Ventilation grills
Lamp chamber
Filter disk
6. Lamp cover
Left side
EVIS LUCERA XENON LIGHT SOURCE CLV-260SL
19
Page 24
Chapter 2 Nomenclature and Functions
1. AC power inlet
Connect the provided power cord to supply the AC power via this inlet.
2. Fuse box
Stores the fuses that protect the instrument from electrical surges.
3. CV terminal
This terminal is the receptacle for the light source cable to connect the light
source to the video system center.
4. Potential equalization terminal
This terminal is connected to a potential equalization terminal of the other
equipment connected to this instrument. The electrical potential of the
equipment are made equal.
5. Water container holder
This holder is used for the installation of the water container.
6. Lamp cover
This cover has to be removed to replace the examination lamp.
20
EVIS LUCERA XENON LIGHT SOURCE CLV-260SL
Page 25
Chapter 3 Inspection
Chapter 3 Inspection
•
Review Chapter 7, “Installation and Connection” thoroughly,
and prepare the instruments properly before inspection. If the
equipment is not properly prepared before each use,
equipment damage, patient and operator injury and/or fire
can occur.
•
Before each procedure, inspect this light source as instructed
below. Inspect other equipment to be used with this light
source as instructed in their respective instruction manuals.
Should any irregularity be observed, do not use the light
source and see Chapter 8, “Troubleshooting”. If the
irregularity is still observed after consulting Chapter 8,
contact Olympus. Damage or irregularity may cause electric
shock, burns and/or fire.
•
Do not leave the examination lamp ON before and/or after
inspection. The distal end temperature of the endoscope may
rise and cause patient and/or operator injury.
Inspect the light source and other equipment to be used with the light source.
Refer to the respective instruction manuals for each piece of equipment.
EVIS LUCERA XENON LIGHT SOURCE CLV-260SL
21
Page 26
Chapter 3 Inspection
3.1
Inspection work flow
Please see the inspection work flow in Figure 3.1 below. Follow each step of the
work flow for inspection of the light source before use.
1. Confirm that the light source is turned ON.
→ Section 3.2, “Inspection of the power supply” on page 23
2. Check the lamp ignition mode.
→ Section 3.3, “Checking the lamp hour indicator” on page 25
3. Confirm that the examination turns ON/OFF normally.
→ Section 3.4, “Inspection of the examination light” on page 26
4. Inspect the necessary functions.
• System mode switching
→ Section 3.5, “Inspecting the system mode switching function” on page 28
• Brightness level adjustment
→ Section 3.6, “Inspection of brightness adjustment” on page 29
• Special light observation
→ Section 3.7, “Inspection of the special light observation” on page 32
• Transillumination
→ Section 3.8, “Inspection of transillumination function” on page 34
• Air and water feed
→ Section 4.8, “Adjusting air/water pressure” on page 51
5. After inspection
→ Section 3.10, “After inspection” on page 38
Figure 3.1
22
EVIS LUCERA XENON LIGHT SOURCE CLV-260SL