HF CABLE Instructions for Use Jan 2021

76 Pages

INSTRUCTIONS FOR USE HF CABLE A00010A A00011A A00012A A0335.1 A0355 A0357 A0358 A0391 A0392 A0393 A60000C A60001C A60002C A60003C O0120.1 WA00013A WA00014A

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File Name: OLYMPUS - W7089000_09 - HF CABLE Instructions for Use Jan 2021 - 2021-01.pdf

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INSTRUCTIONS FOR USE HF CABLE

A00010A A00011A A00012A A0335.1 A0355 A0357 A0358 A0391 A0392

A0393 A60000C A60001C A60002C A60003C O0120.1 WA00013A WA00014A

Contents 1 Using this document... 5 1.1 User instructions... 5 1.2 Conventions throughout this document... 5 1.3 Safety-related information in this document... 6 1.4 Trademarks... 7 2 Safety information... 8 2.1 Intended purpose... 8 2.2 Contact... 9 2.3 General safety notes... 10 3 Product description... 12 3.1 Scope of delivery... 12 3.2 Product functions... 12 3.3 Operating elements... 12 3.4 Symbols... 21 3.5 Warranty... 22 4 Before use... 23 4.1 Inspection... 23 4.2 Attaching the neutral electrode... 24 4.3 Connecting the HF cable (not for WA00014A)... 25 4.4 Connecting the HF cable (only for WA00014A)... 25 5 Use... 28 5.1 Safety notes for use... 28 5.2 Using the product... 30 6 After use... 32 6.1 Disassembly... 32 6.2 Preparation for reprocessing at the point of use... 32 7 General information for reprocessing... 33 7.1 Overview of the reprocessing cycle... 33 7.2 Validated reprocessing methods... 36

8 Cleaning and disinfection... 39 8.1 Safety notes for cleaning and disinfection... 39 8.2 Manual cleaning... 40 8.3 Manual disinfection... 42 8.4 Automated cleaning and thermal disinfection... 43 8.5 Inspection... 46 9 Sterilization... 48 9.1 Safety notes for sterilization... 48 9.2 Steam sterilization... 48 10 Repair, shipment and disposal... 51 10.1 Repair... 51 10.2 Shipment... 51 10.3 Disposal... 52 11 Ordering information... 53 12 Compatible equipment... 54 13 Technical data... 67 13.1 Dimensions... 67 13.2 Specifications... 68 13.3 Ambient conditions... 68 14 Glossary... 69 15 Index... 72

Using this document

1 Using this document This chapter 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 Conventions throughout this document Convention Explanation 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. – Dashes indicate the listing of data, options or objects. – – 1) Numbers with right parenthesis name elements in illustrations. 2) 3) 5

Using this document

1.3 Safety-related information in this document For safe and efficient use of this product it is important to read the complete instructions for use. The safety related information of these instructions for use is not only described in this chapter. All information and instructions in this document are to ensure a safe and efficient use. Safety information are described in 3 categories: – General safety notes – Specific safety notes – Safety messages 1.3.1 General safety notes General safety notes are located at the beginning of the instructions for use. They address safety issues that apply to the general use and handling of the product. 1.3.2 Specific safety notes Specific safety notes are located at the beginning of a chapter or section. They address safety issues that are specific to the information and actions described in the chapter or section. 1.3.3 Safety messages Safety messages focus on unexpected incidents that can occur during the intended use. They are placed in the context of such risks and actions. The safety messages are highlighted by a signal word. WARNING Indicates a potentially hazardous situation which, if not avoided, can result in death or serious injury.

Using this document CAUTION Indicates a potentially hazardous situation which, if not avoided, can result in minor or moderate injury. NOTICE Indicates a property damage message.

1.4 Trademarks – STERRAD® – NX™ – V-PRO® are trademarks of their respective owner.

Safety information

2 Safety information This chapter provides general safety information for using the product. The safety information includes: – Intended purpose – Manufacturer information – General safety notes

2.1 Intended purpose 2.1.1 Intended use and indications A00010A, A00011A, A00012A, A0335.1, A0355, A0357, A0358, A0391, A0392, A0393, A60000C, A60001C, A60002C, A60003C, O0120.1, WA00013A, WA00014A HF cables for electrosurgical use in laparoscopic, endoscopic, and open surgery in combination with compatible active accessories and compatible electrosurgical generators. 2.1.2 Contraindications There are no known contraindications. The intended use and contraindications of the equipment used in combination with the HF cable or adapter must be observed. 2.1.3 Patient target group Not dedicated to any specific patient population. 2.1.4 Intended user Medical use Only for use by a qualified physician or medical personnel under the supervision of a physician. 8

Safety information Only for use in an adequate medical environment. These instructions for use do not explain or discuss clinical procedures. Reprocessing Reprocessing of reusable products may only be performed by qualified hygiene personnel. 2.1.5 Clinical benefits The device is used as part of a system. The clinical benefit of the device lies in its functionality as described by its intended purpose.

2.2 Contact 2.2.1 Manufacturer Olympus Winter & Ibe GmbH Kuehnstr. 61 22045 Hamburg Germany Country-specific information Refer to the contact information for customers included in the scope of delivery for country-specific information. 2.2.2 Incident reporting European Union If a serious incident occurs with the device, report it to the manufacturer and the relevant national authority.

Safety information Eurasian Economic Union If an undesirable event occurs with the device, report it to the manufacturer or the authorized representative. Other regions If a serious incident occurs with the device, report it to the manufacturer and/or the relevant national authority according to national legislation.

2.3 General safety notes The following safety information addresses points that apply to the general handling and use of the product. This information is to be supplemented by the information given in each chapter of this document. Repair and product modifications Unauthorized repairs and product modification can cause injury to the patient and the user. Repairs may only be performed by qualified servicing personnel that has been authorized by Olympus. Refer to the section “Repair” on page 51 for more details. Spare equipment Malfunctions of the product can delay the procedure. To avoid any delays, always have spare equipment available. WARNING Risk of injury to the patient and the user An insufficient understanding of the dangers, warnings, cautions, and instructions can result in serious injury and 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. ● In case of conflicting information, follow the dangers, warnings, cautions, and instructions in this document. 10

Safety information WARNING Risk of injury to the patient and the user The use of damaged equipment, equipment that does not function properly and equipment with illegible or missing markings can cause infection, toxic shock, electrical, mechanical and thermal injury and unintended nerve stimulation. ● Before each use, observe the instructions in the section “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. WARNING Risk of injury to the patient Improperly assembled equipment can cause infection, electrical, mechanical and thermal injury and unintended nerve stimulation. ● Observe the assembly instructions in these instructions for use and the instructions for use of all other products that will be used during the procedure. CAUTION 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 “Compatible equipment” on page 54.

Product description

3 Product description This chapter 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 The product is delivered in unsterile condition. Reprocess the product before first and each subsequent use.

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. Contents – 1 HF cable – Instructions for use – Contact information for customers

3.2 Product functions The HF cable connects the electrosurgical generator to the instrument or HF-resection electrode for the application of HF current during laparoscopic, endoscopic procedures and open surgery.

3.3 Operating elements This section shows all operating elements of the product and gives a brief description of the purpose of these elements.

Product description A00010A

1) Plug (female) For instrument 2) Plug (male) For electrosurgical generator A00011A