ENDOEYE HD II Instructions for Use

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... 7 2.3 User qualification... 8 2.4 Environment of use... 8 2.5 General dangers, warnings and cautions... 8 3 Upon delivery... 12 4 Terminology... 13 4.1 WA50040A, WA50050A... 13 4.2 WA50042A, WA50052A... 15 4.3 Symbols and Labels... 17 5 Technical data... 19 5.1 Specifications... 19 5.2 Safety... 20 5.3 Ambient conditions... 20 6 Compatible components... 21 7 Before use... 22 7.1 Inspection... 22 7.2 Preparation... 24 7.3 Configuration of the remote control buttons... 27 7.4 Testing... 27

8 Use... 29 8.1 Safety... 30 8.2 Procedure... 31 8.3 Troubleshooting... 37 8.4 After use... 37 8.5 Preparation for reprocessing at the point of use... 39 9 Reprocessing... 41 9.1 Safety information for reprocessing... 41 9.2 General information for reprocessing... 42 9.3 Manual cleaning... 45 9.4 Manual disinfection... 48 9.5 Automated cleaning and thermal disinfection... 50 9.6 Maintenance... 53 9.7 General information for sterilization... 54 9.8 Validated sterilization methods... 54 10 Service... 58 10.1 Regular inspection... 58 10.2 Repair... 58 10.3 Final disposal... 59 11 Electromagnetic compatibility... 60

General Information

1 General Information 1.1 User instructions The complete set of instructions for use for this product consists of the product-specific instructions for use (this document) and the system-related instructions for use “System Guide Endoscopy”. • Before use, thoroughly read these instructions for use, the “System Guide Endoscopy”, and the instructions for use of all other products that will be used during the procedure. • 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. DANGER Indicates a hazardous situation which, if not avoided, will result in death or serious injury. 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.

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General Information

1.3 Conventions throughout this document 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. This symbol indicates additional helpful information. 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.

1.4 Trademarks - Cidex OPA® - STERRAD® - NXTM are trademarks of their respective owner.

1.5 Manufacturer Olympus Winter & Ibe GmbH Kuehnstr. 61 22045 Hamburg Germany

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Safety information

2 Safety information 2.1 Intended use 2.1.1 General intended use Video telescope for general surgery in the abdomen and thorax. 2.1.2 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.

2.2 Contraindications 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: 7

Safety information - 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.

2.3 User qualification Medical use This video telescope is to be used only in a medical facility by trained medical personnel.

2.4 Environment of use Medical use This product is only intended to be used in hospitals and medical rooms with appropriate endoscopic equipment. Reprocessing Reusable products must be reprocessed according to the applicable national and local standards and regulations.

2.5 General dangers, warnings and cautions The following dangers, 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. 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. 8

Safety information • Make sure to have the complete set of instructions for use. • Follow the dangers, warnings, cautions, and instructions in the “System Guide Endoscopy”. • In case of conflicting information, follow the dangers, warnings, cautions, and instructions in this document. 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. • Only use endoscopic equipment 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. WARNING 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”. WARNING Read all instruction manuals thoroughly An insufficent understanding of the dangers, warnings, cautions and information in the manuals can result in death, serious injury, or equipment damage.

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Safety information Before use, read this manual, the “System Guide Endoscopy”, and the manuals for all other equipment which will be used during the procedure. CAUTION Risk of injury to the patient and/or the user The use of a damaged product or of a product with improper functioning may cause an electric shock, mechanical injury, infection, and/or thermal injury. • Before each use, observe the instructions in the section “Inspection” in this document. • Do not use a damaged product or a product with improper functioning. • Replace a damaged product or a product with improper functioning. CAUTION Risk of injury to the patient There is a risk of injury to the patient due to malfunction of the equipment. • Always have spare equipment available. NOTICE Risk of damage to the product The endoscope is a precise optical device. Careless handling may damage the endoscope. • Always handle the endoscope with care. • Do not hold the endoscope by the distal end only. • Do not bend the insertion tube. NOTICE Risk of damage to the product Detaching the universal cable from the endoscope may damage the endoscope. • Do not attempt to detach the universal cable from the endoscope. • The universal cable may only be detached by Olympus service personnel.

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Safety information NOTICE Risk of damage to the product A damaged universal cable may damage the endoscope. • Make sure that the universal cable does not touch any sharpedged or pointed objects. Information on EMC/ESD Electromedical devices are subject to special precautionary measures concerning electromagnetic compatibility (EMC) and must be installed and put into operation in accordance with the EMC information provided in the chapter “Electromagnetic Compatibility” in this document. Portable and mobile RF communications equipment can affect medical electrical equipment. Electrical connections may not be touched. Refer to the chapter “Electromagnetic Compatibility” in this document.

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Upon delivery

3 Upon delivery Unpacking • Remove the video telescope from the packaging. Do not use the packaging to store the video telescope. Inspect immediately • Make sure that the shipping case contains the following items: - Video telescope - Instruction manual for video telescope - System Guide Endoscopy • Contact your Olympus represantative 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 product-specific instruction manuals an 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, acccessible location.

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Terminology

4 Terminology 4.1 WA50040A, WA50050A Entire video telescope

1) Objective lens window (WA50040A. with fog-free function) 2) Distal end 3) Instertion 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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Terminology Main body

1) Remote control button SW3 2) Remote control button SW2 3) Remote control button SW1 Light-guide connector

1) Cover glass 2) Light-guide connector

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Terminology Video connector

1) Electrical contacts 2) “Up” mark

4.2 WA50042A, WA50052A Entire video telescope

1) 2) 3) 4)

Objective lens window (WA50042A: with fog-free function) Distal end Insertion tube Remote control buttons 15

Terminology 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 SW3 2) Remote control button SW2 3) Remote control button SW1 Light-guide connector

1) Cover glass 2) Light-guide connector

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Terminology Video connector

1) Electrical contacts 2) “Up” mark

4.3 Symbols and Labels Symbol

Explanation

Symbol

Explanation

Catalog number ​

Type BF applied part

Serial number

Type CF applied part

Quantity of content

Indicates the temperature limits to which the medical device can be safely exposed

Manufacturer

CE certification mark – symbol for the compliance with the Medical Device Directive 93/42/ EEC

Date of manufacture

Consult instructions for use

Caution, consult accompanying documents

Autoclavable

Indicates the range of humidity to which the medical device can be safely exposed

Storage conditions

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Terminology Symbol

Explanation

Explanation

In accordance with European Directive 2002/96/EC on Waste Electrical and Electronic Equipment, this symbol indicates that the product must not be disposed of as unsorted municipal waste, but should be collected separately.

Transport conditions

Federal (USA) law restricts this device to sale by or on the order of a physician

Green Dot-symbol for dual recycling system

Protection class according to IEC 60529: Protected against the effects of temporary immersion in water

Indicates a recovery/recyclable package or package material

Non-sterile

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Symbol

Technical data

5 Technical data 5.1 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...continous

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Technical data

5.2 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

5.3 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 85% Transport conditions Temperature... −47 to 70 °C (−52 to 158 °F) Relative humidity...10 to 95 %

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Compatible components

6 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 prdocuts 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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