ENDOEYE HD II System Instructions

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 1.6 Serious incident reporting... 7 2 Safety information... 8 2.1 Intended use... 8 2.2 Contraindications... 8 2.3 User qualification... 9 2.4 Environment of use... 10 2.5 General safety notes... 10 3 Product description... 13 3.1 Scope of delivery... 13 3.2 Product functions... 13 3.3 Operating elements... 14 3.4 Symbols... 20 3.5 Warranty... 21 4 Before use... 22 4.1 Safety information for preparation... 22 4.2 Inspection... 23 4.3 Assembly and connection... 25 4.4 Checking the image quality... 28 4.5 Configuring the remote control buttons... 28 5 Use... 29 5.1 Safety information for use... 29 5.2 General information for using the video telescope... 32 5.3 Troubleshooting... 34

6 After use... 35 6.1 Disconnecting the light-guide connector... 35 6.2 Disconnecting the video connector... 36 6.3 Preparation for reprocessing at the point of use... 36 7 General information for reprocessing... 38 7.1 Overview of the reprocessing cycle... 39 7.2 Validated reprocessing methods... 41 8 Cleaning... 43 8.1 Safety notes for cleaning... 43 8.2 Manual cleaning... 44 8.3 Automated cleaning... 46 8.4 Inspection and maintenance... 49 9 Sterilization... 51 9.1 Safety notes for sterilization... 51 9.2 Selecting compatible sterilization methods... 52 9.3 Steam sterilization... 52 9.4 Hydrogen peroxide plasma sterilization (Sterrad)... 54 10 Repair, shipment and disposal... 56 10.1 Repair... 56 10.2 Shipment... 56 10.3 Disposal... 57 11 Compatible equipment... 58 12 Technical data... 59 12.1 General dimensions... 59 12.2 Specifications... 59 12.3 Classification of ME equipment and ME systems... 60 12.4 Ambient conditions... 60 13 Electromagnetic compatibility... 61

General information

1 General information This section provides a general information on how to use these instructions for use.

1.1 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.

1.2 Signal words The following signal words are used throughout this document. CONTRAINDICATION Indicates a condition under which the device must not be used because the risk of use clearly outweighs any possible benefit. 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. 3. ● 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 2) 3)

1.4 Trademarks – STERRAD® – NXTM – V-PRO® – neodisher® are trademarks of their respective owner.

1.5 Manufacturer Olympus Winter & Ibe GmbH Kuehnstr. 61 22045 Hamburg Germany 6

General information Refer to the contact information for customers included in the scope of delivery for country-specific information.

1.6 Serious incident reporting If a serious incident occurs with the device, report it to the manufacturer and the relevant national authority.

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Safety information

2 Safety information This section provides a general safety information for using the video telescope. The safety information includes: – Intended Use – Contraindications – Necessary user qualifications – Environment of use – General safety notes

2.1 Intended use This instrument has been designed to be used with a video system center, light source, documentation equipment, monitor, hand instruments, electrosurgical unit, and other ancillary equipment for endoscopy and endoscopic surgery within the thoracic and abdominal cavities including the female reproductive organs.

2.2 Contraindications There are no absolute contraindications 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 contraindications 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. Laparoscopy may also be contraindicated by the following conditions, depending on their severity or extent: – Class IV cardiac decompensation 8

Safety information – – – – – – – – – – –

Bowel obstruction Ileus Cardiac disease Intraperitoneal hemorrhage Diaphragmatic hernia Infection with acute peritonitis Previous abdominal surgery Obesity Thin nulliparous patient Chronic obstructive lung disease Liver failure with established collateral vessels

The intended use and contraindications of the equipment used in combination with the product must be observed.

2.3 User qualification Medical use This video telescope is to be used only in a medical facility by trained medical personnel. These instructions for use do not explain or discuss clinical procedures. Reprocessing Reprocessing of reusable products 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.

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Safety information

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 safety notes The following warnings 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 or in the instructions for use of any product being used with this product. WARNING Risk of injury to the patient and the user The use of a damaged product or of a product with improper functioning can cause an electric shock, mechanical injury, infection and thermal injury. ● Before each use, observe the instructions in the section “4.2 Inspection” on page 23. ● 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 An insufficient understanding of the 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. ● Before use, thoroughly read these instructions for use and the instructions for use of all other products that will be used during the procedure. 10

Safety information WARNING Risk of injury to the patient and the user Using incompatible equipment can lead to injury of the patient and the user as well as damage to the product. ● For information on compatible equipment, refer to the chapter “11 Compatible equipment” on page 58 . ● If combinations are used that are not listed in this chapter, the user takes the full responsibility. WARNING 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. 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 can be additive. ● Only use F-type applied part endoscopic equipment. ● 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. PRECAUTION – Ultrasonography before laparoscopy may identify clinical conditions that will alter patient management.

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Safety information – Abdominal puncture sites 7 mm or greater (for the introduction of auxiliary instrumentation) may be a source of herniation. – Lasers and electrosurgical probes should not be activated simultaneously. Further, when one is activated, the tip of the other should be completely retracted. This avoids deflection of the energy to the other tip. – The abdomen can be adequately distended by pressure in the range of 15–20 mmHg. It is seldom necessary to use an abdominal pressure greater than 20 mmHg. – During unipolar electrosurgery, inadvertent burns can occur when the appropriate patient return path is obstructed or as a result of capacitive coupling. An important maxim: Avoid combinations of devices made of both conducting and insulating materials, especially metal trocars with nonconductive trocar anchors, screws, etc. That is: “Use like with like.” 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. 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.

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Product description

3 Product description This section provides a general overview of the product and its functions. This includes the following information: – Scope of delivery – Product functions – Operating elements – Explanation of symbols – Warranty information

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. WA50040A, WA50042A, WA50050A, WA50052A – Video telescope – Instructions for use – Contact information for customers The product is delivered in unsterile condition. Reprocess the product before first and each subsequent use.

3.2 Product functions A video telescope is a rigid endoscope designed for visual diagnosis and visualization of therapeutic endoscopic procedures. An image sensor inside the distal end of the video telescope converts an optical image into an electronic signal. A bundle of optical fibers transmits light from an external light source to the distal end of the video telescope to obtain illumination. For application, the video telescope is inserted into the patient via compatible trocars, sheaths or ports. For information on compatible equipment, refer to the chapter “11 Compatible equipment” on page 58. 13

Product description Fog-free function (only for WA50040A, WA50042A) The distal end of the video telescope has an automatic fog-free function. The fog-free function is always active when the video connector is connected to the video system center and the video system center is switched on. When the temperature of the distal end of the video telescope is lower than the body temperature, there is no fogging and there is a clear field of view. If the temperature outside the body is low, the fog-free function works slowly.

3.3 Operating elements This section shows all operating elements of the product and gives a brief description of the purpose of these elements. 3.3.1 Video telescope WA50040A, WA50050A Entire video telescope

1) 2) 3) 4) 14

Objective cover glass (WA50040A: with fog-free function) Distal end Remote control buttons Main body

Product description 5) 6) 7) 8)

Universal cable Light-guide connector Video cable Video connector

Main body

1) Remote control button SW1 2) Remote control button SW2 3) Remote control button SW3

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Product description 3.3.2 Video telescope WA50042A, WA50052A Entire video telescope

1) 2) 3) 4) 5) 6) 7) 8) 9)

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Objective cover glass (WA50042A: with fog-free function) Distal end Remote control buttons Adjustment ring for direction of view Main body Universal cable Light-guide connector Video cable Video connector

Product description Main body

1) 2) 3) 4)

Remote control button SW1 Remote control button SW2 Remote control button SW3 Adjustment ring

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Product description Adjustment ring

To change the observation area to the left or right, the distal end can be rotated. ● To rotate the distal end, turn the adjustment ring. 3.3.3 Distal end

1) Objective cover glass 18

Product description 2) Light emission surface 3.3.4 Light-guide connector

1) Cover glass 3.3.5 Video connector

1) Electrical contacts 2) “UP” mark

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Product description

3.4 Symbols This section gives an explanation for each symbol used on the product and on the packaging of the product. Symbol

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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 marking indicating that the device is in conformity with the applicable requirements set out in applicable European Union harmonisation legislation

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

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

Product description Symbol

Explanation Non-sterile

Symbol

Explanation “UP” mark to indicate the top side of the video connector

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.

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