Instructions
98 Pages
Preview
Page 1
INSTRUCTIONS
VISERA XENON LIGHT SOURCE
CLV-S45
USA: CAUTION: Federal law restricts this device to sale by or on the order of a physician.
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 ...
6
Cardiac applications...
11
Summary of the Functions of the Instrument ...
12
Chapter 1
Checking the Package Contents...
14
Chapter 2
Instrument Nomenclature ...
15
2.1
Symbols and descriptions ...
15
2.2
Front panel...
17
2.3
Rear and side panels ...
20
Installation and Connection ...
22
3.1
Installation work flow...
23
3.2
Installation of equipment ...
24
3.3
Connection of the video system...
26
3.4
Connection to the AC mains power supply ...
27
Inspection ...
29
4.1
Inspection work flow...
30
4.2
Inspection of the power supply ...
31
4.3
Connection to an endoscope ...
34
4.4
Inspection of the examination lamp ...
37
4.5
Checking the lamp life indicator ...
40
4.6
Inspection of the light cutoff function...
41
4.7
Inspection of the high intensity mode...
42
4.8
Inspection of brightness control ...
43
4.9
After inspection ...
49
Chapter 3
Chapter 4
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Contents
Chapter 5
Operation...
50
5.1
Operation work flow ...
53
5.2
Recommended video systems and functions...
54
5.3
Turning the light source ON and igniting the examination lamp...
55
5.4
Brightness control (automatic/manual)...
56
5.5
Using the high intensity mode ...
60
5.6
Extinguishing the examination lamp...
60
5.7
Turning the light source OFF ...
61
Lamp Replacement...
62
6.1
When to replace the lamp ...
62
6.2
Replacement of the examination (xenon) lamp...
62
Care, Storage, and Disposal ...
72
7.1
Care ...
72
7.2
Storage ...
73
7.3
Disposal ...
73
Troubleshooting ...
75
8.1
Troubleshooting guide ...
75
8.2
Returning the light source for repair...
79
Appendix...
81
System chart ...
81
Transportation, storage and operating environments...
84
Specifications ...
85
EMC information...
88
Chapter 6
Chapter 7
Chapter 8
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VISERA XENON LIGHT SOURCE CLV-S45
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.
Front side
UDI label The UDI label is required by some countries’ regulations regarding the identification of a medical device also known as Unique Device Identification (UDI).
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Labels and Symbols
Rear side CSA/UL marking
CE marking WEEE marking Connected cable: Refer to instructions. Cautions that the inside of the lamp chamber is extremely hot immediately after the lamp is extinguished.
Blue
Replacement of the examination lamp: Refer to instructions. Serial number plate
Manufacturer name
Potential equalization terminal Electrical rating The product name, rated voltage and frequency are shown. VISERA XENON LIGHT SOURCE MODEL OLYMPUS CLV-S45 POWER INPUT 100 – 240V 50/60Hz 500VA
Back cover of this instruction manual
Manufacturer
Authorized representative in the European Community
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VISERA XENON LIGHT SOURCE CLV-S45
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, video system, and other ancillary equipment for endoscopic diagnosis, treatment and observation. 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 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/video system center Devices that convert endoscopic images from a rigid endoscope, fiberscope or videoscope into video images on a monitor. Videoscope This is an endoscope with a built-in CCD at its distal end to enable you to view images on a monitor without using a camera head. Camera head: The camera head is a device that converts endoscopic images from a fiberscope or a rigid scope into monitor images. Mobile workstation: The mobile workstation is a special trolley on which this light source is placed and used for endoscopic diagnosis and treatment. Wall mains outlet: The wall mains outlet is a wall AC mains power outlet socket with a terminal used exclusively for grounding. Isolation transformer: The isolation transformer is a safety device that is used to isolate non-insulated equipment with potentially high leakage currents to decrease the possibility of electric shock. 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. High intensity mode: This mode emits brighter illumination light than usual. It is available only with the endoscopes and the light guides compatible with this mode.
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VISERA XENON LIGHT SOURCE CLV-S45
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: 2007). 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.
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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.
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.
•
Any applied part except “TYPE CF APPLIED PART” must never be applied directly to the heart and must not be used in procedures involving cardiac observation or surgery. 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 fluids away from all electrical equipment. If fluids are spilled on or into the unit, stop operation of the light source immediately and contact Olympus. Do not prepare, inspect or use this light source with wet hands.
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VISERA XENON LIGHT SOURCE CLV-S45
Important Information - Please Read Before Use
•
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.
•
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.
•
Although the illumination light emitted from the endoscope’s distal end is required for endoscopic observation and treatment, it may also cause alteration of living tissues such as protein denaturation of liver tissue and perforation of the intestines through inappropriate use. Observe the following warnings on 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 this instrument. When this instrument is used with a video system compatible with automatic brightness control function, be sure to use this function. The automatic brightness control can keep the illumination at a proper level. Refer to the instruction manual for the video system for details. Do not continue observation in the proximity to tissue or keep the distal end of the endoscope in contact with living tissue for a long time. It may cause patient burns. When discontinuing the use of the endoscope, be sure to turn this instrument OFF or extinguish the examination lamp by pushing the lamp selector.
•
Do not look directly into the distal end of the endoscope, the distal end of the light guide connector or the output socket of the light source while the light source is ON. The intense light causes eye injury.
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Important Information - Please Read Before Use
•
Do not touch the distal end of the light guide connector of the endoscope, the distal end of the light guide or the output socket of the light source immediately after removing it from this instrument because they are extremely hot. Operator or patient injury can result.
•
Xenon light sources produce significant heat due to the high intensity light required for endoscopic procedures. If the disconnected end of the light guide or the distal end of an endoscope touches operating room drapes or other flammable materials, fire can result. Observe the following warnings: Never place the unattached end of an illuminated light guide on an operating room drape or other flammable material. Never allow the distal end of an illuminated endoscope to come in contact with operating room drapes or other flammable material. Be sure to turn OFF the light source or extinguish the examination lamp whenever the light source is not used.
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•
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 touch the output connector of the light source. Otherwise, an operator or patient injury can result.
•
Do not connect any object other than the light guide and endoscope to the output connector. Otherwise, malfunction may result.
VISERA XENON LIGHT SOURCE CLV-S45
Important Information - Please Read Before Use
•
If the endoscopic image dims during use, blood, mucus or debris may adhere to the light guide on the distal end of the endoscope. Carefully withdraw the endoscope from the patient and remove the blood or mucus in order 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.
•
Always use the power cord provided with this product. Otherwise, the equipment may fail or the power cord may burn. Also note that the provided power cord is designed exclusively for this product and should not be used with other products.
•
Do not use a pointed or hard object to press the buttons on the front panel. This may damage the buttons.
•
Avoid applying excessive force to the connectors, as this may damage the instrument.
•
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 to this instrument when it is placed near equipment marked with the following symbol or other portable and mobile RF (Radio Frequency) communications equipment such as cellular phones. If radio interference occurs, mitigation measures may be necessary, such as reorienting or relocating this instrument or shielding the location.
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Important Information - Please Read Before Use
•
If the spare lamp, instead of the examination lamp, lights up frequently when pressing the power switch to light the examination lamp, this instrument may have already malfunctioned. Return the instrument for repair, following 8.2, “Returning the light source for repair” on page 79.
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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VISERA XENON LIGHT SOURCE CLV-S45
Important Information - Please Read Before Use
Cardiac applications •
Use only the devices listed in the “System chart” in the Appendix 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, 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.
•
The OLYMPUS light guides and camera heads listed in the “System chart” in the Appendix (TYPE CF applied part) that are suitable for cardiac applications bear a mark.
•
The Olympus surgical telescope holder (SH-1) is designed to insulate the endoscope and earth electrically so that it can be used on and in the proximity of the heart.
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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 ancillary equipment used with this instrument. 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 5.3, “Turning the light source ON and igniting the examination lamp” on page 55
Adjusting the examination light When this instrument is used in combination with the video system 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 5.4, “Brightness control (automatic/manual)” on page 56
Selecting the high intensity mode Brighter examination light is available by using an endoscope and light guide that are compatible with high intensity mode operation. Section 5.5, “Using the high intensity mode” on page 60
Monitoring the operating hours of the examination lamp The lamp life 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 4.5, “Checking the lamp life indicator” on page 40
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VISERA XENON LIGHT SOURCE CLV-S45
Summary of the Functions of the Instrument
Automatic switching to spare 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 spare lamp. The spare lamp provides enough brightness for withdrawing the endoscope from the patient’s body. Section 4.2, “Inspection of the power supply” on page 31 and Section 4.4, “Inspection of the examination lamp” on page 37
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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.
Light source (CLV-S45)
Foot holders (MD-512, 4 pcs.)
Power cord
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VISERA XENON LIGHT SOURCE CLV-S45
Instruction manual
Chapter 2 Instrument Nomenclature
Chapter 2 Instrument Nomenclature 2.1
Symbols and descriptions Output connector Connector for endoscope
Power switch Power ON/OFF
Lamp Main lamp (xenon)
Spare lamp (halogen)
High intensity mode
Brightness control Lamp selector
Manual control
Automatic control
Automatic/manual brightness control (minimum) Min.
Max.
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Chapter 2 Instrument Nomenclature
Lamp life meter Lamp life
Others Alternating current Equipotential terminal Caution Caution hot Refer to instructions. Refer to instructions.
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VISERA XENON LIGHT SOURCE CLV-S45
Chapter 2 Instrument Nomenclature
2.2
Front panel
2. Power indicator
3. Output connector
1. Power switch
Control panel Refer to the next page.
1. Power switch Press the switch to turn power ON or OFF. The xenon lamp lights up simultaneously. 2. Power indicator The indicator is lit when the light source is ON. 3. Output connector The connector transmits light to the connected endoscope or the light guide.
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