Instructions
48 Pages
Preview
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INSTRUCTIONS ENDOEYE HD II
WA50040A WA50042A WA50050A WA50052A
Content
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General Information...5 1.1 Intended Use...5 1.2 Upon Delivery...6 1.3 Manufacturer...7
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Terminology...9 2.1 WA50040A, WA50050A...9 2.2 WA50042A, WA50052A...11 2.3 Symbols and Labels...13
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Technical Data...15 3.1 Specifications...15 3.2 Safety...15 3.3 Ambient Conditions...16
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Compatible Components...17
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Before Use...19 5.1 Inspection...19 5.2 Preparation...20 5.3 Configuration of the Remote Control Buttons...21 5.4 Testing...22
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Use...23 6.1 Safety...23 6.2 Procedure...24 6.3 After Use...28
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Reprocessing...31 7.1 Compatible Reprocessing Methods...31 7.2 Manual Cleaning...33 7.3 Machine Cleaning and Disinfection...36 7.4 Maintenance...38 7.5 Loading the Instrument Tray...39 7.6 Sterilization...40
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Service...41 8.1 Regular Inspection...41 8.2 Repair...41 8.3 Final Disposal...41
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Electromagnetic Compatibility...43
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General Information
1.1 Intended Use General intended use Video telescope for general surgery in the abdomen and thorax. Specific intended use -- Transabdominal and retroperitoneal inspection of organs with thoracic access* -- Transabdominal and retroperitoneal treatment of organs with thoracic access* -- Transabdominal and retroperitoneal inspection of organs with minimal-invasive abdominal access* -- Transabdominal and retroperitoneal treatment of organs with minimal-invasive abdominal access* -- Transabdominal and retroperitoneal inspection of organs with single incision abdominal access* -- Transabdominal and retroperitoneal treatment of organs with single incision abdominal access* * gall bladder, appendix, small intestine, colon, spleen, stomach, larynx, esophagus, lung, liver, kidney, rectum, ovaries, fallopian tubes, uterus, vagina, prostate, bladder, ureter, kidney Do not use for any other purposes. Contra-indications There are no absolute contra-indications against laparoscopy/thoracoscopy which would not equally apply to open surgery in general. The operating physician must judge according to professional standards whether a specific procedure is appropriate. Known relative contra-indications against laparoscopy include: -- previous surgery/severe adhesions. -- pulmonary diseases. -- heart diseases. -- pregnancy. Do not use the device for procedures in which it would regularly come in physical contact with the beating heart. Medical use This video telescope is to be used only in a medical facility by trained medical personnel.
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1.2 Upon Delivery Unpacking • Remove the video telescope from the packaging. Do not use the packaging to store the video telescope. • Open the instrument tray. • Remove the video telescope from the instrument tray. Inspect immediately • Make sure that the shipping case contains the following items: -- Video telescope -- Instrument tray WA05955A -- Instruction manual for video telescope -- Instruction manual for instrument tray -- System Guide Endoscopy
• Contact your Olympus representative or an authorized service center if any items are missing or damaged. NOTE Instruction manual set The complete instruction manual set for this product consists of the productspecific instruction manuals and the system-related instruction manual “System Guide Endoscopy”. If either manual is missing, immediately contact an Olympus representative. Keep the instruction manual set in a safe, accessible location.
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WARNING Read all instruction manuals thoroughly An insufficient understanding of the dangers, warnings, cautions, and information in these manuals can result in death, serious injury, or equipment damage. Before use, read this manual, the “System Guide Endoscopy”, and the manuals for all other equipment which will be used during the procedure.
1.3 Manufacturer Olympus Winter & Ibe GmbH Kuehnstr. 61 22045 Hamburg Germany
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Terminology
2.1 WA50040A, WA50050A Entire video telescope
1) Objective lens window (WA50040A: with fog-free function) 2) Distal end 3) Insertion tube 4) Remote control buttons 5) Main body 6) Universal cable 7) Light-guide connector 8) Light-guide adapter 9) Video cable 10) Video connector
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Main body
1) Remote control button SW1 2) Remote control button SW2 3) Remote control button SW3 Light-guide connector
1) Light-guide connector 2) Cover glass Video connector
1) Electrical contacts 2) “Up” mark
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2.2 WA50042A, WA50052A Entire video telescope
1) Objective lens window (WA50042A: with fog-free function) 2) Distal end 3) Insertion tube 4) Remote control buttons 5) Adjustment ring for direction of view 6) Main body 7) Universal cable 8) Light-guide connector 9) Light-guide adapter 10) Video cable 11) Video connector Main body
1) Remote control button SW1 2) Remote control button SW2 3) Remote control button SW3
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Light-guide connector
1) Light-guide connector 2) Cover glass Video connector
1) Electrical contacts 2) “Up” mark
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2.3 Symbols and Labels Caution, consult accompanying documents
Follow instructions for use
Consult instructions for use
Type BF applied part
Type CF applied part
CE certification mark – symbol for the compliance with the Medical Device Directive 93/42/EEC
Catalogue number Serial number 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
Manufacturer
Must not be disposed of as unsorted municipal waste
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Quantity of content Autoclavable
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Technical Data
3.1 Specifications Cable length WA50040A, WA50042A, WA50050A, WA50052A...3 m Insertion tube Outer diameter WA50040A ...10 mm (max. 10.07 mm) WA50042A...10 mm (max. 10.20 mm) WA50050A, WA50052A...5.4 mm (max. 5.45 mm) Working length WA50040A...325 mm WA50042A...330 mm WA50050A...300 mm WA50052A...302 mm Direction of view WA50040A, WA50050A...0° WA50042A, WA50052A...30° Field of view WA50040A, WA50042A... 90° (16:9) WA50050A, WA50052A...72° (16:9), 80° (5:4) TV system WA50040A, WA50042A, WA50050A, WA50052A... 1080i/60 and 1080i/50 Mode of operation WA50040A, WA50042A, WA50050A, WA50052A... continuous
3.2 Safety Protection class against electrical shock (according to IEC 60601-1) WA50040A, WA50042A, WA50050A, WA50052A...Applied Part of a Class I Medical Equipment IP Classification according to IEC/EN 60529 (degree of protection by enclosure) Protected against the effects of temporary immersion in water... IPX7 Classification of Applied Parts (according to IEC 60601-1) WA50040A, WA50042A...Type BF WA50050A, WA50052A... Type CF
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3.3 Ambient Conditions Operating conditions Ambient temperature... 10 to 35 °C (50 to 95 °F) Relative humidity...30 to 85 % Atmospheric pressure...700 to 1060 hPa Storage conditions Temperature... 10 to 40 °C (50 to 104 °F) Relative humidity...30 to 75 % Transport conditions Temperature...-47 to 70 °C (-52 to 158 °F) Relative humidity...10 to 95 %
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Compatible Components WARNING Risk of injury to the patient and/or user Use only compatible equipment as listed in this section. If incompatible combinations are used, the user takes the full responsibility. Future products can also be compatible. For more information, contact an Olympus representative. NOTE Some of the products listed in this chapter may not be available in all sales territories.
11 mm 12 mm
CLV-S40 Pro CLV-180 CLV-S190 CLV-190
WA50040A WA50042A
OTV-S190 CV-190
5.5 mm (5,5 mm)
WA50050A WA50052A OEV261H
WA05955A
WA50040A WA50042A WA50050A WA50052A
WA05938A
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Before Use WARNING Risk of injury to the patient and/or user Make sure that the video telescope is used only in a medical facility by trained medical personnel. CAUTION Risk of damaging the video telescope This video telescope is a precise optical device. Handle with care. CAUTION Risk of damaging the video telescope Make sure that the video system center is switched off before connecting the video connector. If not, the video telescope and/or the video system center can be damaged. Do not apply excessive force when connecting the video connector to the video system center. Make sure that the video connector is not damaged. A damaged video connector can damage the video connector socket and can cause image loss during the procedure.
5.1 Inspection WARNING Infection control risk Improper reprocessing can cause infection of the patient and/or medical personnel. Reprocess the video telescope before first and each subsequent use following the instructions in this manual and in the “System Guide Endoscopy”. WARNING Risk of injury to the patient due to damaged video telescope Inspect the video telescope for visible damage: -- Make sure that the video telescope is free of corrosion, deformations, and scratches. -- Make sure that the objective lens window is not damaged. -- Make sure that the cover glass is not damaged. -- Make sure that the cables and the electrical contacts of the video connector are clean and not damaged. WARNING Risk of injury to the patient The video connector must not be damaged. A damaged video connector can damage the video connector socket and can cause image loss during the procedure.
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CAUTION Risk of image loss Do not touch the electrical contacts inside the video connector.
5.2 Preparation WARNING No modification of the equipment is allowed. Connect the light-guide connector Make sure that the video system center is switched off before connecting the universal cable.
• Connect the universal cable to a compatible light source. Refer to the instruction manual of the light source. CAUTION Risk of damaging the equipment Make sure that the video connector is dry before inserting it into the video connector socket.
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Connect the video connector • Switch off the video system center. • Hold the video connector with the “UP” mark facing upwards.
• Connect the video connector to the video connector socket. Make sure that the video connector clicks into position. WARNING Risk of injury to the patient Make sure that the video connector clicks into position. Otherwise, there may be image loss resulting in patient injury. WARNING Risk of image loss Make sure that all system components are connected properly. Refer to the instruction manual of each component that is used during the procedure.
5.3 Configuration of the Remote Control Buttons Remote control buttons To configure the functions of the remote control buttons, use the menu buttons on the video system center. Refer to the instruction manual of the video system center.
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