Olympus A22000A Instructions For Use Manual

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INSTRUCTIONS FOR USE

Telescope

A5333

A22000A

A22001A

A22002A

A22003A

A22004A

A22005A

A3764A

A4677A

A3765A

WA20016A

A4672A

WA20017A

A4673A

WA20018A

A4674A

WA20021A

A4676A

WA20023A

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Page 1 INSTRUCTIONS FOR USE Telescope A5333 A22000A A3764A A4677A A22001A A3765A WA20016A A22002A A4672A WA20017A A22003A A4673A WA20018A A22004A A4674A WA20021A A22005A A4676A WA20023A...
Page 3: Table Of Contents
CONTENTS 1 General Information ............5 1.1 User Instructions ............5 1.2 Signal Words .............. 5 1.3 Conventions ..............6 1.4 Trademarks ..............6 1.5 Manufacturer ............... 6 2 Safety Information ............... 7 2.1 Intended Use .............. 7 2.2 Contraindications ............8 2.3 User Qualification ............
Page 4 8.4 Automated Cleaning and Disinfection ....... 43 8.5 Maintenance ............. 43 8.6 Sterilization ............... 44 9 Repair and Disposal ............47 9.1 Repair ............... 47 9.2 Disposal ..............48 10 Compatible Equipment............49 11 Technical Data ..............57 11.1 General Dimensions ..........57 11.2 Dimensions for Reprocessing ........
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
- Dashes indicate the listing of data, options or objects. 1) Numbers with right parenthesis name elements in illustrations. 1.4 Trademarks - STERRAD ® - NX are trademarks of their respective owner. 1.5 Manufacturer Olympus Winter & Ibe GmbH Kuehnstr. 61 22045 Hamburg Germany W7090150...
Page 7: Safety Information
2 Safety Information 2.1 Intended Use Olympus telescopes are designed for the visualization of endoscopic diagnosis and treatment in the following fields of application: - Urology - Gynaecology - Otorhinolaryngology Telescope A22000A, A22001A, A22002A, A22003A, A22004A, A22005A In urology: - Cystoscopy - Resectoscopy - Urethrotomy In gynaecology: - Hysteroscopy...
Page 8: Contraindications
- Resectoscopy Telescope A4676A, A4677A In gynaecology: - Hysteroscopy Telescope WA20016A, WA20017A, WA20018A In urology: - Photodynamic diagnosis (PDD) - Cystoscopy - Resectoscopy Telescope WA20021A, WA20023A In urology: - Cystoscopy - Resectoscopy 2.2 Contraindications There are no known contraindications. The intended use and contraindications of the equipment used in combination with the telescope must be observed.
Page 9: Environment Of Use
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 10 WARNING Risk of injury to the patient and/or the user An insufficient understanding of the dangers, warnings, cautions, and instructions can result in serious injury or damage to the product. • Make sure to have the complete set of instructions for use. • Follow the dangers, warnings, cautions, and instructions in the “System Guide Endoscopy”.
Page 11 WARNING Risk of injury to the patient There is a risk of an electric shock when using endoscopic equipment 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.
Page 12 • Repairs may only be performed by qualified servicing personnel that has been authorized by Olympus. • Contact your Olympus representative or an authorized service center for repair 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.
Page 13: Upon Delivery
3 Upon Delivery • Make sure that the shipping case contains all of the items listed below. • Contact an Olympus representative or an authorized service center if any items are missing or damaged. Contents A22000A, A22001A, A22002A, A22003A, A22004A,...
Page 14 Contents WA20021A, WA20023A - Telescope - Instructions for use - System Guide Endoscopy W7090150...
Page 15: Product Description
4 Product Description 4.1 Telescope A telescope is a rigid endoscope. An image relay system transmits the endoscopic image. The image relay system consists of: - rod lenses (A22000A, A22001A, A22002A, A22003A, A22004A, A22005A, A4672A, A4673A, A4674A, WA20016A, WA20017A, WA20018A, WA20021A, WA20023A) - optical fibers (A3764A, A3765A, A4676A, A4677A) A bundle of optical fibers transmits light from an external light source to illuminate the endoscopic image.
Page 16 Entire telescope A22000A, A22001A, A22002A, A22003A, A22004A, A22005A A3764A, A3765A A4672A, A4673A, A4674A A4676A, A4677A WA20016A, WA20017A, WA20018A WA20021A, WA20023A W7090150...
Page 17 Main body A22000A, A22001A, A22002A, A22003A, A22004A, A22005A 1) Insertion tube 2) Connector pin 3) Light-guide connector 4) Color code 5) Eyepiece cup W7090150...
Page 18 Main body A3764A, A3765A 1) Insertion tube 2) Light-guide adapter A0460 3) Light-guide adapter O0332 4) Light-guide connector 5) Eyepiece cup 6) Color code 7) Connector pin W7090150...
Page 19 Main body A4672A 1) Insertion tube 2) Connector pin 3) Light-guide adapter A0460 4) Light-guide adapter O0332 5) Light-guide connector 6) Eyepiece cup A5333 7) Color code 8) Quick-lock connector 9) Ocular thread W7090150...
Page 20 Main body A4673A, A4674A 1) Insertion tube 2) Connector pin 3) Light-guide adapter A0460 4) Light-guide adapter O0332 5) Light-guide connector 6) Color code 7) Eyepiece cup W7090150...
Page 21 Main body A4676A, A4677A 1) Insertion tube 2) Locking cone 3) Light-guide adapter A0460 4) Light-guide adapter O0332 5) Light-guide connector 6) Eyepiece cup A5333 7) Color code 8) Quick-lock connector 9) Ocular thread W7090150...
Page 22 Main body WA20016A, WA20017A, WA20018A 1) Insertion tube 2) Connector pin 3) Light-guide adapter A0460 4) Light-guide adapter O0332 5) Light-guide connector 6) 2 color codes 7) Eyepiece cup Main body WA20021A, WA20023A 1) Insertion tube 2) Connector pin W7090150...
Page 23 3) Light-guide connector 4) Color code 5) Eyepiece cup Color code Green ............0° direction of view Blue ............12° direction of view Red ............30° direction of view Yellow ............70° direction of view Orange ........... 110° direction of view Purple .......for use in photodynamic diagnosis (PDD) Distal end 1) Objective cover glass...
Page 24: Symbols
4.2 Symbols This section gives an explanation for each symbol used on the product and on the packing of the product. Catalog number Serial number Quantity of content Manufacturer Date of manufacture Consult instructions for use 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...
Page 25: Warranty
4.3 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. W7090150...
Page 26: Preparation
5 Preparation 5.1 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 27 Checking the image quality • Hold a piece of writing in a testing distance from the objective cover glass as specified below: A22000A, A22001A, A22002A, A22003A, A22004A, A22005A ............15 mm A3764A, A3765A ............. 7 mm A4672A ................18 mm A4673A ................14 mm A4674A ................
Page 28: Assembly And Connection
• Observe the instructions for use of the compatible system components. 5.3.2 Assembling the Endoscope – Group 1 This section applies only to the following products: A22000A, A22001A, A22002A, A22003A, A22004A, A22005A, A4672A, A4673A, A4674A, WA20016A, WA20017A, WA20018A, WA20021A, WA20023A Connecting the eyepiece cup A5333 for A4672A • Make sure that the thread of the eyepiece cup is completely...
Page 29 5.3.3 Assembling the Endoscope – Group 2 This section applies only to the following products: A4676A, A4677A Removing the telescope from the protective tube • Remove the telescope from the protective tube. Do not use excessive force. Connecting the eyepiece cup A5333 • Make sure that the thread of the eyepiece cup is completely dry.
Page 30 5.3.4 Assembling the Endoscope – Group 3 This section applies only to the following products: A3764A, A3765A Removing the telescope from the protective tube • Remove the telescope from the protective tube. Do not use excessive force. Attaching the telescope 1.
Page 31 5.3.5 Connecting the Light-Guide Cable • Refer to the chapter “Compatible Equipment” to identify the compatible light-guide cable. • If applicable, remove inappropriate light-guide adapters from the telescope. • Observe the instructions for use of the light-guide cable. • Connect the light-guide cable to the light-guide connector of the telescope.
Page 32: Use
6 Use 6.1 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. • Always connect the endoscopic equipment before inserting the endoscope into the patient.
Page 33 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.
Page 34 NOTICE Risk of damage to the product When using the endoscopic equipment in combination with HF electrodes, arc-over may occur between the endoscopic equipment and the HF electrode resulting in damage to the endoscopic equipment. • Always keep a distance of at least 10 mm between the endoscopic equipment and the HF electrode.
Page 35: After Use
7 After Use CAUTION Risk of injury to the user The connectors on the endoscope become hot. There is a risk of burns when touching the connectors. • Let the endoscope cool down after use. Disassembling the endoscope • Switch off the light source. • Disconnect the light-guide cable from the light source.
Page 36 • Reprocess the product according to the instructions in this document and the “System Guide Endoscopy”. W7090150...
Page 37: Reprocessing
8 Reprocessing 8.1 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 38: 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 your Olympus representative for additional information. W7090150...
Page 39 Process A5333, A22000A, A22001A, A22002A, A22003A, A22004A, A22005A, A3764A, A3765A, A4672A, A4673A, A4674A, A4676A, A4677A, WA20016A, WA20017A, WA20018A, WA20021A, WA20023A Preparation at Deposition the point of use Decontamination Preparation Selection according to the cleaning and disinfection procedures Cleaning Manual Ultrasonic...
Page 40 • If applicable, remove the protective tube from the telescope for manual cleaning, automated cleaning and disinfection. 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...
Page 41: Manual Cleaning
- All components of the product must be completely immersed in the detergent. - All lumens of the product must be completely filled with detergent. - Make sure that there are no air bubbles. 8.3 Manual Cleaning 8.3.1 Telescope and Eyepiece Cup A5333 To clean the telescope and the eyepiece cup, choose one of the following cleaning procedures.
Page 42 Cleaning procedure with enzyme-based detergent 1. Immediately after use, flush the product at least 10 times with enzyme-based detergent using a syringe of at least 10 ml. 2. Immerse the product in enzyme-based detergent for at least 15 min. 3. Thoroughly flush all gaps and lumens at least 10 times with enzyme-based detergent using a syringe of at least 10 ml.
Page 43: Automated Cleaning And Disinfection
8.4 Automated Cleaning and Disinfection 8.4.1 Preparation for Automated Cleaning 1. Immediately after use, flush the product with enzyme- based detergent using a syringe of at least 10 ml. 2. Thoroughly rinse the product with deionized water using a cleaning pistol or other rinse device. 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 44: Sterilization
Do not use excessive force. • For loading the instrument tray, proceed as described below. Loading the instrument tray for A5333, A22000A, A22001A, A22002A, A22003A, A22004A, A22005A, A3764A, A3765A, A4672A, A4673A, A4674A, A4676A, A4677A, WA20016A, WA20017A, WA20018A 1. Open the instrument tray.
Page 45 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. 5. Seal the instrument tray in packaging appropriate for sterilization according to local guidelines and your hospital’s protocol.
Page 46 The sterilization of the endoscope in the plastic instrument tray has been validated with steam sterilization only. W7090150...
Page 47: Repair And Disposal
Olympus. Contact your Olympus representative or an authorized service center for repair and warranty information. Warranty claims Any warranty claims towards Olympus are forfeited if the user or unauthorized persons attempt repair or modification of the product. Service centers do not accept warranty claims for damage caused by inadequate packaging.
Page 48: Disposal
9.2 Disposal When disposing of the product or any of its components, follow all applicable national and local laws and guidelines. W7090150...
Page 49: Compatible Equipment
10 Compatible Equipment Use only compatible equipment as listed in this chapter. Olympus recommends the use of Olympus equipment only. Only this combination ensures a proper illumination and color reproduction of the endoscopic image. If combinations are used that are not listed in this chapter, the user takes the full responsibility.
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Page 52 A37014 A WA03200A A37007 A A0460 Storz A37000A A3764A O0332 Wolf A37001A AR-T10E/12E AR-T10EA/12EA AR-TF08E/L08E OTV-S7H-NA-10E/12E A37002A OTV-S7H-1NA-10E/12E OTV-S7H-1D-L08E/F08E OTV-S7ProH-HD-10E/12E A37006A AR-TF2 AR-TL AR-T2 AR-TZ AR-TX AR-TF08E A37005A AR-TL08E MH999E A3765A MH999S W7090150...
Page 53 WA03200A A0460 Storz A4770 A4672A O0332 Wolf A4771 A4772 AR-T10Q/12Q AR-T10Q/12Q A4773 AR-T10QA/12QA AR-TF08E/L08E OTV-SP1H-N-12Q OTV-SP1H-NA-12Q MH-999Q A4742 AR-T10E/12E AR-T10EA/12EA A4743 AR-TF08E/L08E OTV-S7H-NA-10E/12E OTV-S7H-1NA-10E/12E OTV-S7H-1D-L08E/F08E OTV-S7ProH-HD-10E/12E A4673A A2662 AR-TF2 AR-TL AR-T2 A4743 AR-TZ AR-TX AR-TF08E AR-TL08E MH999E A4744 MH999S A4745 A4674A W7090150...
Page 54 WA03200A A0460 Storz O0332 Wolf AR-T10Q/12Q AR-T10Q/12Q A4677A AR-T10QA/12QA AR-TF08E/L08E OTV-SP1H-N-12Q A4776 OTV-SP1H-NA-12Q MH-999Q A4775 AR-T10E/12E AR-T10EA/12EA AR-TF08E/L08E A4676A OTV-S7H-NA-10E/12E OTV-S7H-1NA-10E/12E OTV-S7H-1D-L08E/F08E OTV-S7ProH-HD-10E/12E AR-TF2 AR-TL AR-T2 AR-TZ AR-TX AR-TF08E AR-TL08E MH999E MH999S W7090150...
Page 55 CYF-5A PDD A93200A WA20016A WA20017A WA20018A AR-TL08E/AR-TF-08E OTV-S7 ProH-FD HDTV – CV-180B 1 2 3 CV-180 OEV191 MAJ-1428 ILLUMINATION MODE MAJ-1429 HIGH MODE BRIGHTNESS AUTO – CLV-180B ON/OFF L. M H TRANS LEVEL ON OFF ILLUM 0 100h 300h 500h AUTO COUNTER LAMP...
Page 56 WA03200A WA22367A A0460 Storz WA22366A WA20021A O0332 Wolf AR-T10E/12E WA22067A AR-T10EA/12EA AR-TF08E/L08E OTV-S7H-NA-10E/12E OTV-S7H-1NA-10E/12E OTV-S7H-1D-L08E/F08E OTV-S7ProH-HD-10E/12E WA20023A WA22066A AR-TF2 AR-TL AR-T2 AR-TZ AR-TX AR-TF08E AR-TL08E MH999E WA22016A MH999S A22093A W7090150...
Page 57: Technical Data
11 Technical Data 11.1 General Dimensions Working length A22000A ..............280.2 mm A22001A ..............280.3 mm A22002A ..............282.1 mm A22003A ..............284.2 mm A22004A ..............283.8 mm A22005A ..............283.2 mm A3764A ..............210.8 mm A3765A ..............212.6 mm A4672A ..............
Page 58: Dimensions For Reprocessing
“Reprocessing” in this document. Eyepiece cup A5333 for A4676A, A4677A Diameter a ..............16.5 mm Diameter b ..............9.1 mm Length c ..............31.5 mm 11.3 Specifications Direction of view A22000A ................0° A22001A ................12° A22002A ................30° A22003A ................70° A22004A ................110° W7090150...
Page 59: Ambient Conditions
A22005A ................30° A3764A .................0° A3765A ................30° A4672A .................0° A4673A ................12° A4674A ................30° A4676A .................0° A4677A ................30° WA20016A ................12° WA20017A ................30° WA20018A ................70° WA20021A ................12° WA20023A ................70° 11.4 Ambient Conditions Operating conditions Ambient temperature ......10 to 40 °C (50 to 104 °F) Relative humidity ............30 to 85 % Storage conditions Temperature ........10 to 40 °C (50 to 104 °F) Relative humidity ............30 to 85 %...
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Olympus A22000A Instructions For Use Manual

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