MONOPOLAR HAND INSTRUMENT Handle, Shaft, Jaws Insert Instructions for Use

7.2 Overview of the reprocessing cycle... 34 7.3 General information for reprocessing... 36 7.4 Manual cleaning... 39 7.5 Manual disinfection... 41 7.6 Automated cleaning and thermal disinfection... 42 7.7 Maintenance... 48 7.8 Sterilization... 52 8 Repair, shipment and disposal... 56 8.1 Repair... 56 8.2 Shipment... 56 8.3 Disposal... 56 9 Compatible equipment... 57 10 Technical data... 60 10.1 General dimensions... 60 10.2 Dimensions for reprocessing... 68 10.3 Rated accessory voltage... 70 10.4 Ambient conditions... 71

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® – 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 57.

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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 24. ● 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 in 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. 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. WA69000L, WA69000M, WA69001L, WA69001M, WA69003L, WA69003M: – Handle – Instructions for use WA69300L, WA69300M, WA69300S: – Shaft – Instructions for use

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Product description WA69310L, WA69310M, WA69310S, WA69312L, WA69312M, WA69312S, WA69314L, WA69314M, WA69314S, WA69316L, WA69316M, WA69316S, WA69318L, WA69318M, WA69318S, WA69320L, WA69320M, WA69320S, WA69322M, WA69324M, WA69326S, WA69328S, WA69330L, WA69330M, WA69330S, WA69332L, WA69332M, WA69332S, WA69334L, WA69334M, WA69334S, WA69336L, WA69336M, WA69336S, WA69338L, WA69338M, WA69338S, WA69340L, WA69340M, WA69340S, WA69342L, WA69342M, WA69342S, WA69344L, WA69344M, WA69344S, WA69346L, WA69346M, WA69346S, WA69350L, WA69350M, WA69350S, WA69352L, WA69352M, WA69352S, WA69354M, WA69356L, WA69356M, WA69356S, WA69358L, WA69358M, WA69358S, WA69370L, WA69370M, WA69370S, WA69372L, WA69372M, WA69372S, WA69374L, WA69374M, WA69374S, WA69376L, WA69376M, WA69376S, WA69380M, WA69382M, WA69384L, WA69384M, WA69384S, WA69390L, WA69390M, WA69392L, WA69392M, WA69362M, WA69378M: – Jaws insert – Instructions for use

3.2 Monopolar hand instrument Olympus monopolar 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. For electrosurgical procedures an electrosurgical generator supplies HF current. An HF cable connects the electrosurgical generator and the hand instrument. In order to close the electric circuit, the use of a neutral electrode is required.

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Product description 3.2.1 Handle with deactivatable ratchet WA69000L, WA69000M

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

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Main body Upper shank Ratchet Finger rest Lower shank Release lever Switch for ratchet deactivation

Product description Unhinging the ratchet

● To unhinge the ratchet, press the release lever. Deactivating the ratchet

● To deactivate the ratchet, move the switch toward the proximal end.

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Product description 3.2.2 Handle with ratchet WA69003L, WA69003M

1) 2) 3) 4) 5) 6)

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Main body Upper shank Ratchet Finger rest Lower shank Release lever

Product description Unhinging the ratchet

● To unhinge the ratchet, press the release lever. 3.2.3 Handle with HF connector WA69001L, WA69001M

1) Main body 2) HF connector 3) Upper shank 17

Product description 4) Finger rest 5) Lower shank 3.2.4 Shaft WA69300L, WA69300M, WA69300S

1) 2) 3) 4)

Distal end Release button Proximal end Rotation knob

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 3.2.5 Jaws insert

1) Distal end 2) Proximal end

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Product description

3.3 Size identification Handle

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 (S/M/L) at the final position of the catalog number indicates the size of the shaft. – S = short (250 mm) – M = medium (330 mm) – L = large (430 mm) Jaws insert

The letter (S/M/L) at the final position of the catalog number indicates the size of the jaws insert. – S = short (250 mm) – M = medium (330 mm) – L = large (430 mm)

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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

Explanation Consult instructions for use

Catalog number Quantity of content Batch code Federal (USA) law restricts this device to sale by or on the order of a physician Manufacturer

Date of manufacture

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

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

Storage conditions Transport conditions Indicates a recovery/recyclable package or package material

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

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