HICURA Bipolar Hand Instrument Instructions for Use

7.2 General information for reprocessing... 29 7.3 Manual cleaning... 32 7.4 Automated cleaning and disinfection... 33 7.5 Maintenance... 35 7.6 Sterilization... 38 8 Repair, shipment and disposal... 39 8.1 Repair... 39 8.2 Shipment... 39 8.3 Disposal... 39 9 Compatible equipment... 40 10 Technical data... 41 10.1 General dimensions... 41 10.2 Dimensions for reprocessing... 43 10.3 Rated accessory voltage... 45 10.4 Ambient conditions... 45

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. 1) • 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® - 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 The hand instruments are intended to be used in laparoscopic and endoscopic diagnosis and treatment in the abdomen and thorax. • Do not use for any other purposes. 2.1.2 Specific intended use - Thoracical inspection and treatment of organs with minimalinvasive thoracic access - Transabdominal, retro- and extraperitoneal inspection and treatment of organs with minimal-invasive abdominal access - Transabdominal, retro- and extraperitoneal inspection and treatment of organs with single incision abdominal access - Application of mechanical forces on tissue (grasping, cutting, dissection) and transmitting of high frequency electrical energy for cutting, coagulation and/or carbonization of tissue • 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: - previous surgery/severe adhesions - pulmonary diseases - heart diseases 7

Safety information - pregnancy Laparoscopy may also be contraindicated by the following conditions depending on their severity or extent. - Class IV cardiac decompensation - 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 There are no known additional contraindications. The intended use and contraindications of the equipment used in combination with the hand instrument must be observed.

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 the product 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. 8

Safety information Reprocessing This product 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 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. • 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 and/or the user There is a risk of injury to the patient and/or the user caused by unauthorized repairs and product modification. • 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 40.

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Safety information 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 section “Inspection” on page 20. • Do not use a damaged product or a product with improper functioning. • Replace a damaged product or a product with improper functioning. 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 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.

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Safety information 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 if power is applied for an excessive amount of time. • 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. Do not apply power is excess of 300 W. • Set the output power of the electrosurgical generator to the minimum level that is necessary for the procedure. 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. The jaws insert is delivered with a protection cap. The protection cap is part of the packaging and is not intended for use or storage. • Remove the protection cap from the distal end. WA69002L, WA69002M: - Handle - Instructions for use WA69400M: - Shaft - Instructions for use WA69410M, WA69412M, WA69414M, WA69416M, WA69418M, WA69420M, WA69422M, WA69424M: - Jaws insert - Instructions for use

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. Each hand instrument consists of three components: - Handle - Shaft - Jaws insert The hand instrument components are compatible to each other to a certain extent. 13

Product description For electrosurgical procedures an electrosurgical generator supplies HF current. An HF cable connects the electrosurgical generator and the hand instrument. 3.2.1 Handle with HF connector WA69002L, WA69002M

1) Main body 2) HF connector 3) Color code White: bipolar application 4) Upper shank 5) Finger rest 6) Lower shank

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Product description 3.2.2 Shaft WA69400M

1) 2) 3) 4) 5)

Distal end Release button Proximal end Rotation knob Color code White: bipolar application

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) Color code White: bipolar application

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Product description

3.3 Size identification Handle

WA69002L

WA69002L

The letter (M/L) at the final position of the catalog number and on the upper shank indicates the size of the handle. - M = small to medium (glove size) - L = large (glove size)

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Product description Shaft

The letter at the final position of the catalog number indicates the size of the shaft. - M = medium (330 mm) Jaws insert

The letter at the final position of the catalog number indicates the size of the jaws insert. - M = medium (330 mm)

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

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Product description Symbol

Explanation

Symbol

Explanation

Catalog number

Batch code

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

Storage conditions

Transport conditions

Indicates a recovery/recyclable package or package material

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

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 20. • Do not use a damaged product.

4.2 Inspection 4.2.1 Inspection regarding reprocessing • Make sure that the product has been properly reprocessed. • Visually inspect the product thoroughly. The product must be visually clean. 4.2.2 General inspection • Check that the product has: - no dents, cracks, kinks, or deformations - no deep scratches - no corrosion - no insulation defects - no missing or loose parts • Check all markings on the product for clear visibility.

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Preparation The marking “HICURA M” or “HICURA L” on the handle may fade after several sterilization cycles. In this case it is not required to replace the product. 4.2.3 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 Mechanical damages Endoscopic HF surgical devices are sensitive to mechanical damages, especially on interfaces. 21

Preparation • Check the functionality: - The opening and closing of the handle and jaws 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 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. Advance the jaws insert into the shaft until it stops.

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