HICURA Instrument Basket System Instructions for Use

Contents 1 General information... 5 1.1 User instructions... 5 1.2 Signal words... 5 1.3 Conventions throughout this document... 5 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... 7 2.4 Environment of use... 7 2.5 General warnings and cautions... 8 3 Product description... 10 3.1 Scope of delivery... 10 3.2 Instrument basket system... 10 3.3 Symbols... 13 3.4 Warranty... 14 4 Preparation... 15 4.1 Safety information for preparation... 15 4.2 Inspection... 15 5 Use... 17 5.1 Safety information for use... 17 5.2 Disassembling the instrument... 17 5.3 Maximum load of the instrument basket system... 17 5.4 Loading the instrument basket system... 22 5.5 Steam sterilization... 27 6 After use... 29 6.1 Preparation for reprocessing at the point of use... 29 7 Reprocessing the empty instrument basket system... 30 7.1 Safety information for reprocessing... 30 7.2 General information for reprocessing... 31 7.3 Manual cleaning procedure... 33

7.4 Automated cleaning and disinfection... 34 7.5 Maintenance... 34 7.6 Sterilization... 34 8 Repair and disposal... 35 8.1 Repair... 35 8.2 Disposal... 35 9 Ordering information... 36 10 Compatible equipment... 37 11 Technical Data... 38 11.1 Specifications... 38 11.2 Ambient conditions... 38

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.

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.

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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 The following are trademarks of their respective owner: -- STERRAD® -- NXTM

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

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2 Safety information 2.1 Intended Use Instrument basket system for the protection of endoscopic equipment and accessories during steam sterilization, storage of endoscopic equipment and accessories after steam sterilization and protection during transport. •• Do not use for any other purposes.

2.2 Contraindications A safe steam sterilization can only be assured if the instruments intended for steam sterilization in the sterilization tray are compatible and have been pre-treated according to the respective instructions.

2.3 User qualification This product is only intended to be used 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 equipment. Reprocessing This product must be reprocessed according to the applicable national and local standards and regulations.

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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 and/or damage to the product. -- Check that you 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 The use of a damaged product or of a product with improper functioning may cause infection and mechanical injury. •• Before each use, observe the instructions in the section “Inspection” on page 15 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 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.

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•• Only use compatible equipment as listed in the chapter “Compatible equipment” on page 37 in this document.

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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. WA005956A -- Instrument basket system: -- Instrument basket with mat -- Insert tray -- Lid -- Instructions for use The insert tray is fastened to the instrument basket with a transport lock. •• Remove the transport lock.

3.2 Instrument basket system The instrument basket system is designed for sterilizing compatible hand instruments. It consists of an instrument basket with mat, an insert tray and a lid and is made of stainless steel. It is suitable for steam sterilization. For further information on equipment that can be reprocessed in this instrument basket system, see the chapter “Compatible equipment” on page 37. The outer dimensions are 550 x 255 x 230 mm.

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1) 2) 3) 4)

Lid Insert tray Mat Instrument basket

3.2.1 Instrument basket

1) Latch

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3.2.2 Insert tray

1) Notch 2) Retainer The retainers have notches that have openings for instruments with a diameter of 3 mm, 5 mm and 10 mm.

Openings for instruments: 1) Instrument diameter 10 mm 2) Instrument diameter 5 mm 3) Instrument diameter 3 mm •• Carefully press the instruments into the respective opening of the notch.

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3.2.3 Lid

1) Handle 2) Identification plate 3) Hook

3.3 Symbols This section gives an explanation for each symbol used on the product and on the packing of the product. Catalog number ​ Batch code Quantity of content Manufacturer Date of manufacture Caution, consult accompanying documents Indicates the range of humidity to which the medical device can be safely exposed

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Indicates the temperature limits to which the medical device can be safely exposed Indicates a recovery/recyclable package or package material Autoclavable Must not be disposed of as unsorted municipal waste 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

3.4 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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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. •• Do not use a product that has not been reprocessed. •• Do not use a damaged product. •• Reprocess the product before first and each subsequent use. •• Reprocess the product according to the instructions in chapter “Reprocessing the empty instrument basket system” on page 30 and the instructions in the “System Guide Endoscopy”. •• Use the reprocessing information in this document if the reprocessing information differs from the “System Guide Endoscopy”. •• Before each use, inspect the product as described in the section “Inspection” on page 15 in this document. •• Do not use a damaged product. Even products designed to be reused have a limited service life. A number of factors regarding handling and some reprocessing methods may lead to increased wear of the product. The service life can be markedly shortened. The product must be replaced if signs of wear become visible.

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. General inspection 1. Check that: -- the instrument basket system has no dents, cracks, kinks, or deformations. 15

-- the instrument basket system has no corrosion. -- there are no missing or loose parts. -- there are no distortions or warping that impact the proper positioning and alignment of the lid and the base. -- there are no distortions or warping that impact the proper function of the catch. 2. Check all markings on the product for clear visibility. •• Do not use a damaged instrument basket system.

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5 Use 5.1 Safety information for use WARNING Risk of injury to the patient and/or the user Improper reprocessing of the endoscopic equipment with nonvalidated methods can cause infection of the patient and/or medical personnel. •• For compatible reprocessing methods observe the productspecific instructions for use of the endoscopic equipment.

5.2 Disassembling the instrument WARNING Risk of injury to the patient and/or the user Some instruments may not be reprocessed properly if they are not disassembled before loading into the instrument basket system. This may cause infection of the patient and/or the user. •• Observe the instructions for use of the instrument to check how to reprocess the instrument properly. •• If necessary, disassemble the instrument that will be reprocessed in the instrument basket system.

5.3 Maximum load of the instrument basket system This section describes only the maximum load of the instrument basket system. For loading the instrument basket system, refer to the section “Loading the instrument basket system” on page 22. WARNING Risk of injury to the patient and/or the medical personnel Sterilizing too many instruments, instruments touching each other or assembled instruments may lead to injury of the patient. •• Do not exceed the maximum capacity of the instrument basket system as given in this section. •• Check that the instruments do not touch each other. 17

•• Reprocess an instrument in assembled condition only if this is described in the instructions for use of the instrument. For instruments that are approved to be placed in the instrument basket system, refer to the chapter “Compatible equipment” on page 37. The following sections describe 2 options for loading the instrument basket system. Do not mix these options. Only load hand instruments consisting of handles, shafts and jaws inserts or load other compatible instruments. 5.3.1 Option 1: Hand instruments This section only describes the loading of hand instruments that consist of handles, shafts and jaws inserts. Maximum capacity: 8 assembled or disassembled hand instruments •• Disassemble the hand instruments as described in the respective product-specific instructions for use. •• Place handles and jaws inserts in the instrument basket. •• Place shafts and/or assembled hand instruments in the insert tray. The following loading charts show examples for the maximum loading of the instrument basket and the insert tray.

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Example 1

8 assembled hand instruments in the insert tray Example 2

4 shafts and 4 assembled hand instruments in the insert tray

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4 handles and 4 jaws inserts in the instrument basket 5.3.2 Option 2: Other compatible instruments Maximum capacity: -- 5 trocars -- 2 trocar spikes -- 1 suction/irrigation system -- 1 needle holder -- 2 electrodes •• Disassemble the instruments as described in the respective product-specific instructions for use. •• Place needle holders, electrodes and suction/irrigation tubes in the insert tray. •• Place the other compatible instruments in the instrument basket. The following loading charts show examples for the maximum loading of the instrument basket and the insert tray.

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Example

Disassembled needle holder, electrodes and suction/ irrigation tube in the insert tray

Disassembled instrument parts in the instrument basket

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