OLYMPUS HiQ+ Bipolar Hand Instrument Instruction for Use

Hand instrument set The instructions for use are valid for the following hand instrument sets. WA63050C, WA63051C, WA63120C, WA63121C, WA63200C, WA63201C, WA63210C, WA63211C, WA63310C, WA63311C, WA63320C, WA63321C, WA63360C, WA63361C These items fall under the provisions of EC-directive 93/42/EEC, Article 12. For information on components of a hand instrument set, refer to the section “Components of a hand instrument set” on page 17.

Contents 1 General information... 7 1.1 User instructions... 7 1.2 Signal words... 7 1.3 Conventions throughout this document... 8 1.4 Trademarks... 8 1.5 Manufacturer... 8 2 Safety information... 9 2.1 Intended use... 9 2.2 Contraindications... 9 2.3 User qualification... 10 2.4 Environment of use... 10 2.5 General warnings and cautions... 10 3 Product description... 14 3.1 Scope of delivery... 14 3.2 Bipolar hand instrument... 14 3.3 Components of a hand instrument set... 17 3.4 Symbols... 18 3.5 Warranty... 18 4 Preparation... 19 4.1 Safety information for preparation... 19 4.2 Inspection... 19 4.3 Assembly and connection... 21 5 Use... 24 5.1 Safety information for use... 24 6 After use... 26 6.1 Removal and disassembly... 26 6.2 Preparation for reprocessing at the point of use... 28 7 Reprocessing... 29 7.1 Safety information for reprocessing... 29

7.2 General information for reprocessing... 29 7.3 Manual cleaning... 32 7.4 Automated cleaning and disinfection... 33 7.5 Maintenance... 34 7.6 Sterilization... 36 8 Repair, shipment and disposal... 37 8.1 Repair... 37 8.2 Shipment... 37 8.3 Disposal... 37 9 Compatible equipment... 38 10 Technical data... 41 10.1 General dimensions... 41 10.2 Dimensions for reprocessing... 42 10.3 Rated accessory voltage... 44 10.4 Ambient conditions... 44

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. 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 -- STERRAD® -- NX™ -- CIDEZYME® -- Sekumatic® 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 For laparoscopic and endoscopic diagnosis and treatment in the abdomen and thorax. •• Do not use for any other purposes. 2.1.2 Specific intended use -- Transabdominal and retroperitoneal inspection and treatment of organs with minimal-invasive access. -- Thoracic inspection and treatment of organs with minimalinvasive access. •• Do not use for any other purposes.

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: -- pregnancy -- tendency to hernias -- tissue fatigue -- adhesions caused by previous operation -- tendency to wound infection The intended use and contraindications of the equipment used in combination with the hand instrument must be observed.

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Safety information

2.3 User qualification Medical use This product is only intended to be used by a trained physician. These instructions for use do not explain or discuss clinical procedures. Reprocessing Reprocessing of reusable products may only be performed by qualified hygiene 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 warnings and cautions The following warnings and cautions apply to the general handling of the product. This information is to be supplemented by the warnings and cautions given in each chapter of 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. •• Make sure to have the complete set of instructions for use. •• Follow the dangers, warnings, cautions, and instructions in the “System Guide Endoscopy”. 10

Safety information •• In case of conflicting information, follow the dangers, warnings, cautions, and instructions in this document. WARNING Risk of injury to the patient and/or the user There is a risk of injury to the patient and/or the user caused by unauthorized repairs and product modification. Possible injuries include mechanical injuries, electric shock, burns, and toxication. •• Do not attempt to repair or modify the product. 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” on page 38. WARNING Risk of injury to the patient and/or user Exceeding the rated accessory voltage may damage the insulation. There is a risk of thermal injury. •• The maximum output voltage of the electrosurgical generator must not exceed the rated accessory voltage of any of the HF accessories used during the procedure. •• Set the output power of the electrosurgical generator to the minimum level that is necessary for the procedure. WARNING 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 chapter “Inspection” on page 19. •• Do not use a damaged product or a product with improper functioning. •• Replace a damaged product or a product with improper functioning.

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Safety information 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. 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 Bending the instrument may damage the product. •• Do not bend the instrument. NOTICE Risk of damage to the product The distal end of the jaws insert is equipped with a ceramic insulation. Mechanical impacts may damage the ceramic insulation. •• Always handle the hand instrument with care. •• Protect the jaws insert from fall.

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Safety information For safety information on HF application, refer to the “System Guide Endoscopy” and the instructions for use of all other HF equipment used in combination with the hand instrument.

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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. Hand instrument sets WA63050C, WA63051C, WA63120C, WA63121C, WA63200C, WA63201C, WA63210C, WA63211C, WA63310C, WA63311C, WA63320C, WA63321C, WA63360C, WA63361C: -- Hand instrument set (hand instrument components: handle, shaft, jaws insert) -- Instructions for use Handles WA60101C: -- Handle -- Instructions for use Shafts WA60800C, WA60801C: -- Shaft -- Access information sheet Jaws inserts WA64050C, WA64051C, WA64120C, WA64121C, WA64200C, WA64201C, WA64210C, WA64211C, WA64310C, WA64311C, WA64320C, WA64321C, WA64360C, WA64361C: -- Jaws insert -- Access information sheet

3.2 Bipolar hand instrument Olympus bipolar hand instruments are designed for laparoscopic use in order to grasp and cut tissue with or without HF current. 14

Product description Each hand instrument set consists of three components: -- Handle -- Shaft with detachable release button -- Jaws insert The hand instrument components are compatible to each other to a certain extent. For electrosurgical procedures an electrosurgical generator supplies HF current. An HF cable connects the electrosurgical generator and the hand instrument. For further information on components of a hand instrument set, refer to the section “Components of a hand instrument set” on page 17. For information on compatibility, refer to the chapter “Compatible equipment” on page 38. 3.2.1 Handle WA60101C

1) HF connector 2) Upper shank 3) Lower shank 15

Product description 4) Color code yellow: HiQ+ bipolar 3.2.2 Shaft WA60800C, WA60801C

1) 2) 3) 4) 5)

Distal end Release button (A03441A) Proximal end Rotation knob Color code yellow: HiQ+ bipolar

Rotating the jaws insert

The jaws insert can be rotated around the longitudinal axis of the hand instrument by turning the rotation knob.

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Product description 3.2.3 Jaws insert

1) Distal end 2) Proximal end

3.3 Components of a hand instrument set Each hand instrument set consists of a jaws insert, a shaft, and a handle as listed in the table below. Hand instrument set Description

Components Set

Grasping forceps, Manhes Grasping forceps, fenestrated Grasping forceps, Hirsch Grasping forceps, tweezers Dissection forceps, Maryland Dissection forceps, Maryland Dissection forceps, straight

Jaws

Shaft

Handle

WA63050C

WA64050C

WA60800C

WA60101C

WA63051C

WA64051C

WA60801C

WA60101C

WA63120C

WA64120C

WA60800C

WA60101C

WA63121C

WA64121C

WA60801C

WA60101C

WA63200C

WA64200C

WA60800C

WA60101C

WA63201C

WA64201C

WA60801C

WA60101C

WA63210C

WA64210C

WA60800C

WA60101C

WA63211C

WA64211C

WA60801C

WA60101C

WA63320C

WA64320C

WA60800C

WA60101C

WA63321C

WA64321C

WA60801C

WA60101C

WA63360C

WA64360C

WA60800C

WA60101C

WA63361C

WA64361C

WA60801C

WA60101C

WA63310C

WA64310C

WA60800C

WA60101C

WA63311C

WA64311C

WA60801C

WA60101C

All shafts include a detachable release button (A03441A). 17

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

Explanation

Symbol

Explanation

Catalog number ​

Quantity of content

Batch code

Manufacturer Date of manufacture

Consult instructions for use

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

Transport conditions

Storage conditions

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

Indicates a recovery/recyclable package or package material

Green Dot symbol for dual recycling system

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

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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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. •• For reprocessing the product, observe the instructions in the chapter “Reprocessing” on page 29. •• Do not use a product that has not been reprocessed. •• Before each use, inspect the product as described in the section”Inspection” on page 19. •• Do not use a damaged product.

4.2 Inspection Inspection regarding reprocessing •• Make sure that the product has been properly reprocessed. •• Visually inspect the product thoroughly. The product must be visually clean. 4.2.1 General inspection •• Check that the product has: -- no dents, cracks, kinks, or deformations -- no deep scratches -- no corrosion -- no missing or loose parts -- no insulation defects •• Check all markings on the product for clear visibility. •• Make sure that the shaft is equipped with a release button.

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Preparation 4.2.2 Specific inspection

Insulation defects and thermal damages HF surgical devices are sensitive to insulation defects and thermal damages.

•• Check that the shaft and the jaws insert have no insulation defects, e.g. under magnification. Insulation defects are: -- holes -- cuts -- cracks -- shrinking -- strong discoloration •• Check that the distal end of the jaws insert has no HF damages. HF damages are: -- welding spots -- melted metal

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Preparation Mechanical damages Endoscopic HF surgical devices are sensitive to mechanical damages, especially on interfaces. •• Check the functionality: -- The opening and closing of the handle and jaw must be smooth. -- The rotation of the shaft must be smooth. •• Check that the product has: -- no mechanical damages on the teeth of the jaw -- no deformation on the proximal end of the jaws insert

4.3 Assembly and connection 4.3.1 Attaching the release button •• Attach a release button to the shaft. 4.3.2 Inserting the jaws insert To avoid injuries, cover the distal end of the jaws insert with a cloth. If force is required to assemble the product, dispose of the product and use another one.

1. Press the release button and insert the proximal end of the jaws insert into the distal end of the shaft.

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Preparation Advance the jaws insert into the shaft until it stops.

2. Slightly turn the distal end of the jaws insert to lock it. 3. Release the release button. 4.3.3 Attaching the handle 1. Open the handle as wide as possible. 2. Hold the handle at the upper shank.

3. Insert the assembled jaws insert and shaft into the handle. 4. Advance the shaft until it stops.

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