Related Manuals for Olympus OES ELITE
Summary of Contents for Olympus OES ELITE
- Page 1 INSTRUCTIONS FOR USE TELESCOPE WA2P400A WA2T400A WA2T412P WA2T412A WA2T430P WA2T430A WA2T470P WA2T470A WA2T43WA...
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Page 3: Table Of Contents
Contents 1 General information ..............5 1.1 User instructions ..............5 1.2 Signal words ................5 1.3 Conventions throughout this document ........6 1.4 Trademarks ................6 1.5 Manufacturer ................6 2 Safety information ..............7 2.1 Intended use ................7 2.2 Contraindications .............. - Page 4 7 Reprocessing ................ 27 7.1 Safety information for reprocessing ........27 7.2 General information for reprocessing ........28 7.3 Manual cleaning ..............31 7.4 Manual disinfection .............. 33 7.5 Automated cleaning and disinfection ........33 7.6 Maintenance ................. 34 7.7 Sterilization ................34 8 Repair, shipment and disposal ..........
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Page 5: General Information
• Use the instructions in this document if the instructions differ from the “System Guide Endoscopy”. • If the required instructions for use are missing, immediately contact an Olympus representative. • Keep the instructions for use in a safe, accessible location. 1.2 Signal words The following signal words are used throughout this document. -
Page 6: Conventions Throughout This Document
- Dashes indicate the listing of data, options or objects. 1) Numbers with right parenthesis name elements in illustrations. 1.4 Trademarks - STERRAD ® - NX - Cidex OPA ® are trademarks of their respective owner. 1.5 Manufacturer Olympus Winter & Ibe GmbH Kuehnstr. 61 22045 Hamburg Germany... -
Page 7: Safety Information
• Do not use for any other purposes. Telescope WA2T412P, WA2T430P, WA2T470P In urology: - Photodynamic diagnosis (PDD) - Cystoscopy - Resectoscopy • Do not use for any other purposes. Protective tube WA2P400A Protective tube to protect OES ELITE telescopes during transport, storage and steam sterilization. -
Page 8: Contraindications
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. 2.4 Environment of use Medical use This product is only intended to be used in hospitals and medical rooms with appropriate endoscopic equipment. -
Page 9: General Warnings And Cautions
Safety information 2.5 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 dangers, warnings and cautions given in each chapter in this document, in the “System Guide Endoscopy” or in the instructions for use of any product being used with this product. - Page 10 • Do not attempt to repair or modify the product. • Repairs may only be performed by qualified servicing personnel that has been authorized by Olympus. • Contact an Olympus representative or an authorized service center for repair information.
- Page 11 Safety information 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. • For information on compatible equipment, refer to the chapter “Compatible equipment”...
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Page 12: Product Description
3 Product description 3.1 Scope of delivery • Before use, check that all items listed below are available. • Contact an Olympus representative or an authorized service center if any items are missing or damaged. WA2T400A, WA2T412A, WA2T430A, WA2T470A, WA2T43WA:... - Page 13 Product description For information on compatibility, refer to the chapter “Compatible equipment” on page 41. 3.2.1 Telescope WA2T400A, WA2T412A, WA2T430A, WA2T470A, WA2T43WA Entire telescope Main body 1) Insertion tube 2) Connector pin 3) Light-guide connector 4) Color code Green: 0° direction of view Blue: 12°...
- Page 14 Product description 3.2.2 PDD telescope WA2T412P, WA2T430P, WA2T470P Entire telescope Main body 1) Insertion tube 2) Connector pin 3) Light-guide adapter A0460 4) Light-guide connector 5) Color code Blue: 12° direction of view Red: 30° direction of view Yellow: 70° direction of view Purple: for use in photodynamic diagnosis (PDD) 6) Eyepiece cup...
- Page 15 Product description 3.2.3 Distal end 1) Objective cover glass 2) Light emission surface 3.2.4 Eyepiece cup 1) Eyepiece cover glass...
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Page 16: Protective Tube
Product description 3.2.5 Direction of view The direction of view is indicated in degree on the main body of the telescope. 3.3 Protective tube The protective tube is a rigid tubular device that protects the telescope from mechanical stress during transport, storage and steam sterilization. -
Page 17: Symbols
Product description WA2P400A 1) Distal end 2) Clamping piece 3) Proximal end 3.4 Symbols This section gives an explanation for each symbol used on the product and on the packaging of the product. Symbol Explanation Symbol Explanation Catalog number Autoclavable Serial number In combination with a high resolution camera head and... -
Page 18: Warranty
Medical Device Directive 93/42/ 3.5 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. -
Page 19: Preparation
Preparation 4 Preparation 4.1 Safety information for preparation WARNING Risk of injury to the patient and/or the medical personnel Improper and/or incomplete reprocessing can cause infection of the patient and/or medical personnel as well as damage to the product. • Reprocess the product before first and each subsequent use. •... - Page 20 Preparation General inspection of the telescope • Check that the product has: - no dents, cracks, bending, or deformations - no deep scratches - no corrosion - no lens damages or cover glass damages - no missing or loose parts •...
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Page 21: Assembly And Connection
Preparation • Check that the image is not cloudy, out of focus or dark. General inspection of the protective tube • Check all markings on the product for clear visibility. 4.3 Assembly and connection If force is required for assembly: 1. - Page 22 Preparation 4.3.3 Attaching the telescope • Insert the telescope into the telescope channel of the system component. • Make sure that the connector pin clicks into position. 4.3.4 Connecting the light-guide cable • Refer to the chapter “Compatible equipment” on page 41 to identify the compatible light-guide cable.
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Page 23: Use
5 Use 5.1 Safety information for use WARNING Risk of injury to the patient There is a risk of an electric shock when the endoscopic equipment is inserted into the patient and the remote end of the light-guide cable comes in contact with the mains power. •... -
Page 24: Procedure
• Only ignite when the laser emission part is visible on the endoscopic image. 5.2 Procedure Using PDD mode Olympus recommends to use PDD mode for diagnosis only and white light imaging during treatment. -
Page 25: After Use
After use 6 After use 6.1 Removal and disassembly If force is required for disassembly, dispose of the product. CAUTION Risk of injury to the user The connectors on the endoscope become hot. There is a risk of burns when touching the connectors. •... -
Page 26: Preparation For Reprocessing At The Point Of Use
After use • Check that the light-guide connector clicks into the clamping piece. Do not use excessive force. 6.3 Preparation for reprocessing at the point of use • Immediately after use, bring the product to the reprocessing area. • Reprocess the product according to the instructions in this document and the “System Guide Endoscopy”. -
Page 27: Reprocessing
Reprocessing 7 Reprocessing 7.1 Safety information for reprocessing WARNING Risk of injury to the patient and/or the medical personnel Improper and/or incomplete reprocessing can cause infection of the patient and/or medical personnel as well as damage to the product. • Reprocess the product before first and each subsequent use. •... -
Page 28: General Information For Reprocessing
For detailed information on reprocessing methods, refer to the “System Guide Endoscopy”. Method validated for microbiological efficacy and verified for material compatibility Method verified for material compatibility – Incompatible Contact an Olympus representative for additional information. Not tested... - Page 29 Reprocessing Process WA2T400A WA2P400A WA2T412A WA2T430A WA2T470A WA2T43WA WA2T412P WA2T430P WA2T470P Preparation at the Deposition point of use Decontamination Preparation Selection according to the cleaning and disinfection procedures Cleaning Manual Ultrasonic – – Alkaline detergent Acidic detergent Neutral detergent Machine Alkaline detergent Acidic...
- Page 30 The equipment must be disassembled. For information on disassembly, refer to the chapter “After use” on page 25. Cleaning brush In the following reprocessing instructions, Olympus uses the terms “appropriate brush” and “appropriate surface brush”. Select an appropriate brush/surface brush according to the following...
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Page 31: Manual Cleaning
• Only use brushes which the manufacturer has designated for reprocessing of medical devices. • Refer to the “System Guide Endoscopy” for further information on Olympus brushes. For the dimensions of the product, refer to the section “Dimensions for reprocessing” on page 46. - Page 32 Reprocessing 2. Immerse the product in enzyme-based detergent for at least 20 min. 3. Thoroughly rinse the product and all gaps at least 10 times with enzyme-based detergent using a syringe of at least 10 ml. 4. Thoroughly brush all gaps at least 10 times with an appropriate surface brush.
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Page 33: Manual Disinfection
Reprocessing 6. Thoroughly rinse all surfaces and flush all lumens again with fresh enzyme-based detergent using a syringe of at least 10 ml. 7. Thoroughly rinse the product with deionized water using a cleaning pistol or other rinse device for at least 30 s. The cleaning pistol or other rinse device must be suitable for cleaning medical devices and deliver a minimum pressure of 1 bar (14.5 psi). -
Page 34: Maintenance
Reprocessing - Telescope: - Neodisher MediClean forte manufactured by Dr. Weigert - Neodisher Z manufactured by Dr. Weigert - Protective tube: - Sekumatic FR manufactured by Henkel-Ecolab - Neodisher Z manufactured by Dr. Weigert 7.6 Maintenance Inspecting the telescope • Visually inspect the product thoroughly after cleaning. The product must be visually clean. - Page 35 Reprocessing • For STERRAD sterilization, refer to the section “STERRAD ® ® sterilization” on page 37. 7.7.1 Steam sterilization Preparing the telescope for steam sterilization • Choose one of the following two options to prepare the telescope for steam sterilization. Option 1: Attaching the telescope to the protective tube •...
- Page 36 Reprocessing Option 2: Loading the instrument tray WA05990A 1. Open the instrument tray. 2. Place the product into the instrument tray as shown in the figure. 3. Press the telescope into the notches. 4. Close the instrument tray.
- Page 37 Reprocessing 5. Seal the instrument tray in packaging appropriate for sterilization according to local guidelines and your hospital’s protocol. Steam sterilization conditions • Refer to the “System Guide Endoscopy” for detailed information on steam sterilization. • Steam sterilization of the product has been validated at 132 °C for 3 min.
- Page 38 Reprocessing STERRAD low temperature plasma sterilization procedure ® STERRAD systems ® Different STERRAD systems with different cycles exist in ® the market. The information provided on STERRAD in this ® document applies to the following cycles: - STERRAD 100S: short cycle and long cycle ®...
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Page 39: Repair, Shipment And Disposal
WARNING Risk of infection for the servicing personnel Sending used products to Olympus represents a risk of infection for the personnel. Olympus is entitled to refuse soiled or contaminated products for reasons of safety. -
Page 40: Disposal
Repair, shipment and disposal 8.3 Disposal When disposing of the product or any of its components, follow all applicable national and local laws and guidelines. -
Page 41: Compatible Equipment
Compatible equipment 9 Compatible equipment Olympus recommends the use of equipment as listed in this chapter. If combinations are used that are not listed in this chapter, the user takes the full responsibility. Future equipment may also be compatible. For more information, contact an Olympus representative. - Page 42 Compatible equipment...
- Page 43 Compatible equipment...
- Page 44 Compatible equipment WA2P400A WA2T400A WA2T412P WA2T412A WA2T430P WA2T430A WA2T470P WA05990A WA2T470A WA2T43WA...
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Page 45: Technical Data
Technical data 10 Technical data 10.1 General dimensions 10.1.1 Telescope Working length WA2T400A ..............280.2 mm WA2T412A ..............280.0 mm WA2T430A ..............282.2 mm WA2T470A ..............284.0 mm WA2T43WA ..............283.3 mm WA2T412P ..............280.0 mm WA2T430P ..............282.2 mm WA2T470P .............. -
Page 46: Dimensions For Reprocessing
Technical data 10.2 Dimensions for reprocessing This section lists all relevant dimensions for reprocessing the product. For reprocessing the product, refer to the chapter “Reprocessing” on page 27. Protective tube WA2P400A L1: Length ................. 305 mm D1: Inner diameter 1 ............5.0 mm D2: Inner diameter 2 ............ - Page 47 Technical data Storage conditions Temperature .........10 to 40 °C (50 to 104 °F) Relative humidity ............30 to 85% Transport conditions Temperature ........−40 to 70 °C (−40 to 158 °F) Relative humidity ............10 to 95%...
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