Instructions for Use
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INSTRUCTIONS FOR USE OLYMPUS CLL-V1
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Content 1 General Information... 5 1.1 Signal Words... 5 1.2 Conventions... 5 1.3 User Instructions... 5 1.4 Manufacturer... 5 2 Safety Information... 6 2.1 Intended Use... 6 2.2 User Qualification... 6 2.3 Environment of Use... 6 2.4 General Warnings and Cautions... 7 3 Upon Delivery... 8 4 Product Description... 9 4.1 Symbols... 9 4.2 Warranty... 11 5 Preparation... 12 5.1 Safety Information for Preparation... 12 5.2 Inspection... 12 5.3 Installing the Foot Holders... 13 5.4 Connecting the Light Source to the Mains Supply... 13 5.5 Connecting the Light-Guide Cable... 14 5.6 Testing the Light Source... 14 6 Use... 15 6.1 Safety Information for Use... 15 7 Troubleshooting... 17 8 After Use... 18 9 Cleaning and Disinfection... 19 9.1 Safety Information for Cleaning and Disinfection... 19 9.2 Manual Cleaning and Disinfection... 19 10 Maintenance... 21 10.1 Annual Inspection... 21 10.2 Replacing the Fuses... 21 11 Transport and Storage... 22 12 Repair and Disposal... 23 12.1 Repair... 23 12.2 Disposal... 23
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13 Compatible Equipment... 24 14 Technical Data... 25 14.1 Specifications... 25 14.2 Ambient Conditions... 25 14.3 Safety... 25 14.4 Power Cable... 26 15 Electromagnetic Compatibility... 27
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1 General Information 1.1 Signal Words The following signal words are used throughout this document. 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. NOTICE Indicates a property damage message.
1.2 Conventions This is the safety alert symbol. It is used to alert the user to potential physical injury hazards. Observe all safety messages that follow this symbol to avoid possible injury. 1. A numeration indicates a sequence of actions. 2. • Bullet points indicate individual actions or different options for action. -- Dashes indicate the listing of data, options or objects. 1) Numbers with right parenthesis name elements in illustrations.
1.3 User Instructions • Before use, thoroughly read these instructions for use and the instructions for use of all other products that will be used during the procedure. • If the required instructions for use are missing, immediately contact an Olympus representative. • Keep the instructions for use in a safe, accessible location.
1.4 Manufacturer Olympus Winter & Ibe GmbH Kuehnstr. 61 22045 Hamburg Germany W7089150
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2 Safety Information 2.1 Intended Use Light source for use with a compatible telescope, camera head, video system center, and other ancillary equipment. The light source is to be used for endoscopic diagnosis, treatment and video observation in the following fields: -- Bronchoscopy -- Otorhinolaryngology -- Urology -- Gynaecology -- General surgery -- Gastroenterology • Do not use for any other purposes.
2.2 User Qualification Medical use This product is only intended to be used by a trained physician or trained qualified medical personnel under the supervision of a physician. These instructions for use do not explain or discuss clinical procedures. Cleaning and disinfection Cleaning and disinfection of the product may only be performed by qualified hygiene personnel. Repair Repair of the product may only be performed by trained qualified servicing personnel that has been authorized by Olympus. Otherwise, Olympus cannot be held responsible for the safety and performance of the product.
2.3 Environment of Use Medical use This product is only intended to be used in hospitals and medical rooms with appropriate endoscopic equipment. Location This product must not be used in a flammable atmosphere. Cleaning and disinfection This product must be cleaned and reprocessed according to the applicable national and local standards and regulations.
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2.4 General Warnings and Cautions The following warnings and cautions apply to the general handling of the product. This information is to be supplemented by the warnings and cautions given in each chapter in this document or in the instructions for use of any product being used with this product. WARNING Risk of injury to the patient Other electrical devices can interfere with the function of the OLYMPUS CLL-V1. • Do not place the OLYMPUS CLL-V1 next to, on or under other electrical devices. If the OLYMPUS CLL-V1 must be placed next to, on or under other electrical devices, monitor the OLYMPUS CLL-V1 during the procedure to make sure that the OLYMPUS CLL-V1 does not switch off and that the brightness does not change. WARNING Risk of injury to the patient and/or the user Light emitted from the light-guide cable or endoscope can damage the retina. • Make sure that the light-guide cable or endoscope does not point at the patient’s or user’s eye. • Do not look directly into the light emitted from the light-guide cable or endoscope. WARNING Risk of injury to the patient and/or the user There is a risk of injury to the patient due to malfunction of the equipment. • Always have spare equipment available. CAUTION Risk of injury to the patient and/or the user Using incompatible equipment may lead to injury of the patient and/or the user as well as damage to the product. • Only use compatible equipment as listed in the chapter “Compatible Equipment” in this document.
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3 Upon Delivery • Make sure that the shipping case contains the following items: -- Light source -- 4 foot holders -- Stencil for foot holders -- 2 spare fuses -- Instructions for use • Contact an Olympus representative or an authorized service center if any items are missing or damaged.
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4 Product Description Light source, front
1) 2) 3) 4)
Power switch with power indicator Socket for light-guide cable Brightness control buttons (- and +) Brightness display
Light source, rear panel
1) 2) 3) 4)
Ventilation slots Potential equalization conductor Power supply with fuse holder Identification plate
4.1 Symbols This section gives an explanation for each symbol used on the product and on the packing of the product. Catalog number
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Quantity Serial number Manufacturer
Follow instructions for use
Caution, consult accompanying documents
Indicates the range of humidity to which the medical device can be safely exposed
Indicates the temperature limits to which the medical device can be safely exposed
CE certification mark – symbol for the compliance with the Medical Device Directive 93/42/EEC Potential equalization
Fuse Type BF applied part
cTUVus marking
Symbol to indicate compliance with EMC requirements by the Japanese Ministry of Health, Labour, and Welfare
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In accordance with European Directive 2002/96/EC on Waste Electrical and Electronic Equipment, this symbol indicates that the product must not be disposed off as unsorted municipal waste, but should be collected separately
4.2 Warranty Any warranty claims towards Olympus are forfeited if the user or unauthorized persons attempt repair or modification of the product. No warranty is provided for any damage due to misuse of the product.
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5 Preparation 5.1 Safety Information for Preparation WARNING Risk of injury to the patient There is a risk of an electric shock when using endoscopic equipment in combination or when using endoscopic equipment in combination with energized endotherapy devices. The patient leakage currents may be additive. • Before each use, check the applied part classification of the endoscopic equipment and especially the energized endotherapy devices used during the procedure. • Only use endoscopic equipment in combination or endoscopic equipment in combination with energized endotherapy devices that meet at least the same requirements of applied part classification. This is particularly important if a type CF applied part endoscope is used. In this case a type CF applied part energized endotherapy device should be used to minimize total leakage current. • For the applied part classification, refer to the respective instructions for use. CAUTION Risk of injury to the patient Blocking the ventilation slots can cause overheating. As a result, the light will first be dimmed and eventually be switched off. • Check that the ventilation slots are not blocked.
5.2 Inspection Inspection regarding cleaning and disinfection • Make sure that the product has been properly cleaned and disinfected. • Visually inspect the product thoroughly. The product should have no signs of visual contamination and should be visually clean. Inspecting the light source • Visually inspect the light source. Check that: -- the technical condition permits a safe use. -- all labels are clearly visible. -- the air inlets on the bottom side of the light source and the ventilation slots are clean. Inspecting the electrical contacts • Check the electrical contacts of all equipment which will be used during the procedure for corrosion. If any electrical contacts are corroded, replace the equipment.
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5.3 Installing the Foot Holders NOTICE Risk of damage to the product If the OLYMPUS CLL-V1 falls, it will be damaged. • Protect the OLYMPUS CLL-V1 against falls. Install the foot holders that are delivered with the OLYMPUS CLL-V1 as described below. 1. Put the stencil on the surface where the OLYMPUS CLL-V1 will be set up. 2. Remove the protective foil from the foot holders. 3. Place the foot holders in the cut-outs of the stencil. The adhesive side must face down. 4. Remove the stencil. 5. Place the OLYMPUS CLL-V1 on the foot holders. Make sure that the feet of the OLYMPUS CLL-V1 fit into the foot holders.
5.4 Connecting the Light Source to the Mains Supply According to IEC 60601-1 requirements, the OLYMPUS CLL-V1 is equipped with a potential equalization conductor. • If local safety regulations require, connect the OLYMPUS CLL-V1 to a potential equalization line. 1. Connect the power cable to the light source. 2. Connect the other end of the power cable to the mains socket. Connect the light source only to a grounded alternating current mains supply that complies with the requirements of IEC 60320-1 / C13 and the information given in the chapter “Technical Data”. The power cable must not be longer than 4.5 m.
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5.5 Connecting the Light-Guide Cable
1. Connect the light source connector to the light source. The light source connector must click into position. 2. Check the light-guide cable for visible damage. Refer to the instructions for use of the light-guide cable. 3. Test the light transmission of the light-guide cable. Refer to the instructions for use of the light-guide cable.
5.6 Testing the Light Source The light source keeps the settings from the previous use. Functional test 1. Switch on the light source. All indicators and displays light up for a few seconds. The light output is activated. 2. Check the quality of the endoscopic image. Refer to the instructions for use of the endoscope, light-guide cable, camera control unit and the monitor. 3. Check the brightness display of the light source.
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6 Use 6.1 Safety Information for Use WARNING Risk of injury to the patient A malfunction of the OLYMPUS CLL-V1 can lead to injury of the patient. • If the OLYMPUS CLL-V1 shows any signs of malfunction or unexpected behavior during use, contact an Olympus representative or an authorized service center. Do not use the OLYMPUS CLL-V1. WARNING Risk of injury to the patient The endoscope, the video equipment, and the OLYMPUS CLL-V1 are classified as type BF instruments according to IEC 60601-1. Using the endoscope can have a serious effect on the cardiac function (e.g. ventricular fibrillation). • Never let the endoscope or any of the instruments that are used during the procedure come in contact with the heart or any tissue near the heart. CAUTION Risk of injury to the patient Light sources emit large amounts of energy. As a result the connectors of the endoscopic equipment and the distal end of the endoscope become hot. There is a risk of: -- thermal injury to the patient’s tissue (e.g., from prolonged exposure to the intense illumination in cavities with small lumens, or if the distal end of the endoscope is placed into close proximity to the tissue). -- burns to the patient’s or user’s skin. -- burns or thermal damage to surgical equipment (e.g., surgical drapes, plastic materials, etc.). • Do not place the endoscopic equipment on the patient’s skin, on flammable materials, or on heat-sensitive materials. • Set the output power of the light source to the minimum level that is necessary for a sufficient illumination of the target area. Avoid prolonged exposure to intense illumination. • Switch off the light source if not used. CAUTION Risk of injury to the patient Light sources emit large amounts of energy. As a result, the temperatures in front of the light emission surface increase. There is a risk of thermal injury to the patient’s tissue. • Do not use high intensity illumination in cavities with small lumens. • Do not use high intensity illumination when the distal end of the endoscope is placed into close proximity to the tissue. • If the distal end is soiled, remove the endoscope from the trocar tube and clean the distal end. WARNING Risk of injury to the patient LED light offers a different color reproduction than conventional light sources. This can cause incorrect diagnoses. W7089150
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• Perform a white balance before using the OLYMPUS CLL-V1. Additionally, perform a white balance after changing the endoscope.
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7 Troubleshooting Problem
Cause
Countermeasure
The power indicator and the brightness display do not illuminate.
No power supply.
Check whether the light source has been switched on. Check whether the power cable of the light source has been properly connected. Replace the fuse. Refer to section “Replacing the Fuses”. If these measures do not solve the problem, contact an Olympus representative.
The power indicator is flashing.
Error in light source.
Switch off the light source. Switch on the light source. If these measures do not solve the problem, contact an Olympus representative.
The light source does not emit light.
No power supply or brightness setting too low.
Check whether the light source has been switched on. Check whether the power cable of the light source has been properly connected. Check whether the light-guide cable has been properly connected to the light source. Increase the brightness setting. Switch off the light source. Switch on the light source. If these measures do not solve the problem, contact an Olympus representative.
Brightness decreases during the procedure.
Light source gets hot.
Switch off the light source. Allow the light source to cool down. If these measures do not solve the problem, contact an Olympus representative.
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8 After Use CAUTION Risk of injury to the user The connectors on the light-guide cable become hot. There is a risk of burns when touching the connectors. • Let the light-guide cable cool down after use. Preparing the light source for cleaning and disinfection 1. Switch off the power switch. 2. Disconnect the power cable. 3. Make sure that the light source has completely cooled down to room temperature to avoid any risk of ignition or explosion. 4. Disconnect the light-guide cable from the light source.
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9 Cleaning and Disinfection 9.1 Safety Information for Cleaning and Disinfection WARNING Risk of injury to the patient and/or user Liquids entering the OLYMPUS CLL-V1 or its accessories during reprocessing can cause a malfunction. • Make sure that no liquids enter the OLYMPUS CLL-V1 or its accessories during reprocessing. WARNING Risk of infection for the user Patient debris and reprocessing chemicals are hazardous. • Wear personal protective equipment to guard against dangerous chemicals and potentially infectious material. • During cleaning and disinfection, wear appropriate personal protective equipment, such as eye wear, face mask, moisture-resistant clothing and chemical-resistant gloves that fit properly and are long enough so that no part of the skin is exposed. • Always remove contaminated protective equipment before leaving the reprocessing area. NOTICE Risk of damage to the product Cleaning can scratch the surfaces and deform or corrode the connectors and electrical contacts. • Do not clean the connectors or electrical contacts of the OLYMPUS CLL-V1. • Do not wipe the surfaces with an abrasive material. The surfaces will be scratched.
9.2 Manual Cleaning and Disinfection • When using 70 % alcohol, make sure that the system has cooled down to room temperature. • Refer to national and local guidelines regarding when using alcohol as disinfectant. Cleaning the surfaces Perform the following cleaning procedure immediately after use. If cleaning is delayed, organic debris will solidify and it may be difficult to clean the surfaces. 1. Remove all dust and soiling with a soft cloth moistened with neutral detergent solution (approved by the manufacturer for cleaning plastic and metal surfaces). Do not exceed maximum recommended levels of concentration given by the manufacturer of the solution. 2. Dry the surfaces with a clean, lint-free cloth. Disinfecting the surfaces • Make sure to disinfect the equipment regularly. W7089150
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• Wipe surfaces with a cloth that has been moistened with a disinfectant. Use an alcohol based disinfectant according to the field of applications. The disinfectant must be approved by the manufacturer for the surface disinfection of medical devices and for the material to be disinfected. • Refer to local/national guidelines regarding the approval of using alcohol as disinfectant. • Refer to the instructions given by the manufacturer of the disinfectant. Make sure not to exceed the manufacturer’s specification on temperature and concentration. • Never immerse the equipment in liquid.
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10 Maintenance 10.1 Annual Inspection WARNING Risk of injury to the patient and/or user When the OLYMPUS CLL-V1 is opened, it can be damaged. • Do not open the OLYMPUS CLL-V1. There are no user-serviceable parts inside. For service, contact an authorized service center. To determine and evaluate the safety status of the medical system, the system operator must perform a technical safety check at least every 12 months. Inspecting the light source 1. Clean the ventilation slots on the back of the light source. 2. Clean the air inlets in the bottom of the light source. 3. Check that the ventilation slots are not covered. 4. Check that the light source is properly connected to the mains supply. 5. If necessary, replace the fuse. 6. Check the function of the system. Checking the LED operating hours To check the LED operating hours, the user must access the service mode of the light source: 1. Simultaneously press both brightness control buttons (- and +) while switching on the light source. 2. Keep both brightness control buttons pressed until the power indicator starts flashing. The service mode is active. The bar graph on the display indicates the LED operating hours. A flashing LED is equivalent to at least 500 operating hours; a continuously lit LED is equivalent to at least 1000 operating hours. The LED can only be replaced by an authorized service center. The LED must be serviced after 2000 operating hours.
10.2 Replacing the Fuses Removing the fuse holder 1. Switch off the light source. 2. Remove the power cable from the light source. 3. Remove the fuse holders. 4. Replace the fuses. The standard set contains two spare fuses (T 3.15 A 250 V). Reinserting the fuse holder 1. Reinsert the fuse holder. 2. Reconnect the power cable. 3. Switch on the light source.
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