Olympus A00010A Instructions For Use Manual

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INSTRUCTIONS FOR USE

HF CABLE

A00010A

A0393

A00011A

A60000C

A00012A

A60001C

A0335.1

A60002C

A0355

A60003C

A0357

O0120.1

A0358

WA00013A

A0391

WA00014A

A0392

Table of Contents

Summary of Contents for Olympus A00010A

Page 1 INSTRUCTIONS FOR USE HF CABLE A00010A A0393 A00011A A60000C A00012A A60001C A0335.1 A60002C A0355 A60003C A0357 O0120.1 A0358 WA00013A A0391 WA00014A A0392...
Page 3: Table Of Contents
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 ................
Page 4 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 ..........
Page 5: Using This Document
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.
Page 6: Safety-Related Information In This Document
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.
Page 7: Trademarks
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.
Page 8: Safety Information
– 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.
Page 9: Contact
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.
Page 10: General Safety Notes
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.
Page 11 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. ●...
Page 12: 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. Contents – 1 HF cable –...
Page 13 Product description A00010A 1) Plug (female) For instrument 2) Plug (male) For electrosurgical generator A00011A 1) Plug (female) For instrument 2) Plug (male) For electrosurgical generator...
Page 14 Product description A00012A 1) Plug (female) For instrument 2) Plug (male) For electrosurgical generator A0335.1 1) Plug (female) For instrument 2) Plug (male) For electrosurgical generator...
Page 15 Product description A0355 1) Plug (female) For instrument 2) Plug (male) For electrosurgical generator A0357 1) Plug (female) For instrument 2) Plug (male) For electrosurgical generator...
Page 16 Product description A0358 1) Plug (female) For instrument 2) Plug (male) For electrosurgical generator A0391 1) Plug (female) For instrument 2) Plug (male) For electrosurgical generator...
Page 17 Product description A0392 1) Plug (female) For instrument 2) Plug (male) For electrosurgical generator A0393 1) Plug (female) For instrument 2) Plug (male) For electrosurgical generator...
Page 18 Product description A60000C 1) Plug (female) For instrument 2) Plug (male) For electrosurgical generator A60001C 1) Plug (female) For instrument 2) Plug (male) For electrosurgical generator...
Page 19 Product description A60002C 1) Plug (female) For instrument 2) Plug (male) For electrosurgical generator A60003C 1) Plug (female) For instrument 2) Plug (male) For electrosurgical generator...
Page 20 Product description O0120.1 1) Plug (female) For instrument 2) Plug (male) For electrosurgical generator WA00013A 1) Right angle plug For working element 2) Straight plug For working element 3) Plug (male) For electrosurgical generator...
Page 21: Symbols
Product description WA00014A 1) Right angle plug For working element 2) Straight plug For working element 3) Plug (male) For electrosurgical generator 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...
Page 22: Warranty
Storage conditions Duration of use in months 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.
Page 23: Before Use
Before use 4 Before use This chapter describes all necessary steps to prepare the product for each use. WARNING Risk of injury to the patient and the medical personnel Improper or incomplete reprocessing can cause infection of the patient and medical personnel as well as damage to the product. ●...
Page 24: Attaching The Neutral Electrode
Contact an authorized service center for repair. 4.2 Attaching the neutral electrode This section applies only to the following products: A00010A, A00011A, A00012A, A0335.1, A0355, A0357, A0358, A0391, A0392, A0393, O0120.1 ● Refer to the instructions for use of the electrosurgical generator and the neutral electrode.
Page 25: Connecting The Hf Cable (Not For Wa00014A)
Before use 4.3 Connecting the HF cable (not for WA00014A) CAUTION Risk of injury to the patient and the user Accidentally disconnecting the HF cable can cause sparkover leading to electrical injury, thermal injury or unintended nerve stimulation. ● Check that the HF cable is securely connected to the instrument and the electrosurgical generator.
Page 26 Before use ● Check that the HF cable is securely connected to the instrument and the electrosurgical generator. 1. Connect the right angle plug of the HF cable to the respective HF connector of the working element. 2. Connect the straight connector of the HF cable to the respective HF connector of the working element.
Page 27 Before use 4. Insert the plug into the socket “Universal” of the electrosurgical generator. Make sure that the markings on the plug and the socket are aligned.
Page 28: Use
5 Use This chapter describes the following: – Safety information for use – Information on how to use the product 5.1 Safety notes for use CAUTION Risk of injury to the patient Contact between the HF cable and the patient can cause leakage current.
Page 29 CAUTION Risk of injury to the patient and user There is a risk of sparkover leading to electrical injury, thermal injury and unintended nerve stimulation. ● The maximum output voltage of the electrosurgical generator must not exceed the lowest maximum rated voltage of any of the HF equipment used during the procedure.
Page 30: Using The Product
● Place the patient on a dry, electrically insulating surface. ● Prevent any contact between different skin surfaces (arms, legs) of the patient. Place dry gauze between the body and arms and between the legs to prevent such contact. ● Prevent any skin contact between the patient and the user. CAUTION Risk of injury to the patient Laying the HF cable in loops can lead to mechanical injury.
Page 31 – Power 200 W – Effect 2 – Mode: <SalineCoag> – Power 120 W – Effect 2 ● Check that the correct setting <Saline> appears on the display. ● If the correct setting is not displayed, disconnect the plug and try again.
Page 32: After Use
After use 6 After use This chapter describes all necessary steps to treat the product after each use. This section provides the following: – Disassembly instructions – The necessary steps to prepare the product for reprocessing at the point of use 6.1 Disassembly 1.
Page 33: General Information For Reprocessing
General information for reprocessing 7 General information for reprocessing This chapter gives a general overview of the reprocessing cycle and the compatible reprocessing methods for the product. The product is delivered in unsterile condition. Reprocess the product before first and each subsequent use. WARNING Risk of injury to the patient and the medical personnel Improper or incomplete reprocessing can cause infection of the...
Page 34 General information for reprocessing Following the reprocessing process is important because improper and incomplete reprocessing can cause infections and can damage the product. The following sections of these instructions for use include detailed information on every validated reprocessing method.
Page 35 General information for reprocessing Preparation for reprocessing at the point of use Refer to section “Preparation for reprocessing at the point of use” on page 32. Select manual cleaning or automated cleaning method. Manual cleaning Automated cleaning (Only for A0335.1, A0357, and thermal A0358, A0393, A60000C, disinfection...
Page 36: Validated Reprocessing Methods
They also provide standardized and validated procedures. Olympus recommends steam sterilization Olympus recommends to use steam sterilization for the product. 7.2 Validated reprocessing methods In accordance with ISO 17664, the following table provides an overview over the reprocessing methods that are validated for the microbiological efficacy of the product.
Page 37 General information for reprocessing Phase Method Compatibility Compatibility Only for Only for A0335.1, A00010A, A0357, A00011A, A0358, A00012A, A0393, A0355, A60000C, A0391, A0392 A60001C, A60002C, A60003C, O0120.1, WA00013A, WA00014A Cleaning Preparation Selection according to the reprocessing method Cleaning Manual Ultrasonic –...
Page 38 General information for reprocessing Detailed instructions on the individual reprocessing methods are located in the following chapters of these instructions for use.
Page 39: Cleaning And Disinfection
Cleaning and disinfection 8 Cleaning and disinfection This chapter describes all necessary steps for cleaning and disinfection of the product. This is a prerequisite for the subsequent sterilization steps. 8.1 Safety notes for cleaning and disinfection Compatible detergents and disinfectants Cleaning and disinfection avoid infections of patients and the medical personnel.
Page 40: Manual Cleaning
– Brushes must meet all general requirements for cleaning brushes as specified above. 8.2.2 Validated detergent Olympus has validated manual cleaning of the product with the following detergent: – Neodisher MediZym 0.5% manufactured by Chemische Fabrik Dr. Weigert GmbH und Co. KG –...
Page 41 Cleaning and disinfection If other detergents are used, select immersion times, concentrations and temperatures of the solutions as instructed by the manufacturer of the detergent. 8.2.3 Manually cleaning the product A complete manual cleaning cycle consists of 3 steps: – Cleaning –...
Page 42: Manual Disinfection
Only use automated cleaning and thermal disinfection for these products. Refer to the section “Automated cleaning and thermal disinfection” on page 43. 8.3.1 Validated disinfectant Olympus has validated manual disinfection of the product with the following disinfectant: – Cidex Activated Dialdehyde solution manufactured by Johnson & Johnson –...
Page 43: Automated Cleaning And Thermal Disinfection
Cleaning and disinfection Specific instructions for these steps are given on the following pages. Disinfection 1. Create a disinfectant solution as instructed by the manufacturer of the disinfectant. 2. Completely immerse the HF cable in the disinfectant for 45 minutes. Make sure that there are no air bubbles on the products while immersed.
Page 44 ● Reprocess the product according to the instructions in these instructions for use. 8.4.1 Validated detergents Olympus has validated automated cleaning of the product with the following detergent and neutralizer: Detergent for manual precleaning – Neodisher MediZym manufactured by Chemische Fabrik Dr.
Page 45 Cleaning and disinfection 8.4.2 Automatically cleaning and disinfecting the product A complete automated cleaning and thermal disinfection cycle consists of 4 mandatory steps: – Precleaning – Preparing for automated cleaning – Selecting programs for the washer-disinfector – Removing the product from the washer-disinfector Specific instructions for these steps are given on the following pages.
Page 46: Inspection
– Pre-cleaning – Cleaning – Neutralization – Final rinsing with deionized water Olympus has validated automatic cleaning with the following program: – Vario TD program – Pre-cleaning for 4 min. – Cleaning for 10 min. at 55 °C (131 °F) –...
Page 47 Cleaning and disinfection 2. Check all markings on the product for clear visibility. Checking for performed reprocessing 1. Make sure that the product has been properly reprocessed. 2. Visually inspect the product thoroughly. The product must be visually clean. 3. Only use the product if it is visually clean. Reprocess the product again if necessary.
Page 48: Sterilization
The product must be completely dry before sterilization. Steam sterilization in Olympus plastic instrument trays Olympus plastic instrument trays are only compatible with steam sterilization. They cannot be used for any other sterilization method. Sterilization wraps and pouches Use only sterilization wrap and pouches that are certified for the selected sterilization method.
Page 49 Do not stack instrument trays. Do not load instrument trays on their side edges. Validated sterilization accessories Olympus has validated steam sterilization of the product with the following sterilization accessories: – WIPAK sterilization pouches manufactured by Steriking – H200 sterilization wrap manufactured by Halyard Health 9.2.2 Compatible steam sterilization conditions...
Page 50 Sterilization Drying time For steam sterilization, Olympus recommends a drying time of at least 15 to 30 minutes. ● Choose a suitable drying time, depending on the autoclave. ● Refer to the instructions for use of the autoclave. 9.2.3 After sterilization Removing from the autoclave 1.
Page 51: Repair, Shipment And Disposal
10 Repair, shipment and disposal This chapter provides instructions on the following: – How to contact Olympus for any repairs – How to ship the product to Olympus for repair or warranty claims – Disposal of the product 10.1 Repair...
Page 52: Disposal
Repair, shipment and disposal When sending products to an authorized service center for repair or warranty claims, use the original cardboard packaging for the transport of the product. If this is not possible, wrap each product individually in sufficient paper or sheets of foamed material and place them in a cardboard box.
Page 53: Ordering Information
Ordering information 11 Ordering information Description Catalog number A00010A HF cable, monopolar A00011A HF cable, monopolar HF cable, monopolar A00012A A0335.1 HF cable, monopolar A0355 HF cable, monopolar HF cable, monopolar A0357 A0358 HF cable, monopolar A0391 HF cable, monopolar...
Page 54: Compatible Equipment
Compatible equipment 12 Compatible equipment Olympus recommends the use of equipment as listed in this chapter. If combinations are used that are not listed in this chapter, the user takes the full responsibility. Future equipment can also be compatible. For more information, contact an Olympus representative.
Page 55 Compatible equipment A00010A, A00011A, A00012A A37014A A00010A A20716A ESG-400 A00011A ESG-410 A00012A ESG-400 ESG-410 * All electrosurgical generators satisfying the interface requirements can be connected to the HF cable. For non- Olympus electrosurgical generators, refer to the below interface requirements.
Page 56 Compatible equipment HF cable Interface requirements for electrosurgical generators (non-Olympus) A00010A Pin diameter: 6 mm Maximum rated voltage: 2000 V Maximum crest factor: 6.5 A00011A Pin diameter: 4 mm (spring basket) Maximum rated voltage: 2000 V Maximum crest factor: 6.5...
Page 57 ESG-400 ESG-410 WA69001M WA69001L WA69003L WA69003M A0358 UES-30 WA69000L UES-40 WA69000M ESG-400 ESG-410 WA51138A * All electrosurgical generators satisfying the interface requirements can be connected to the HF cable. For non- Olympus electrosurgical generators, refer to the below interface requirements.
Page 58 Compatible equipment HF cable Interface requirements for electrosurgical generators (non-Olympus) A0355 Pin diameter: 6 mm Maximum rated voltage: 2000 V Maximum crest factor: 6.5 A0357 Pin diameter: 4 mm (spring basket) Maximum rated voltage: 2000 V Maximum crest factor: 6.5...
Page 59 Compatible equipment A0391, A0392, A0393 WA22066A A0391 WA22067A A0392 ESG-400 ESG-410 A0393 ESG-400 ESG-410 * All electrosurgical generators satisfying the interface requirements can be connected to the HF cable. For non- Olympus electrosurgical generators, refer to the below interface requirements.
Page 60 Compatible equipment HF cable Interface requirements for electrosurgical generators (non-Olympus) A0391 Pin diameter: 6 mm Maximum rated voltage: 2000 V Maximum crest factor: 6.5 A0392 Pin diameter: 4 mm (spring basket) Maximum rated voltage: 2000 V Maximum crest factor: 6.5...
Page 61 WA69410M WA69400M WA69412M WA69414M WA69002M WA69416M WA69003L WA69418M WA69420M WA69422M WA69424M ESG-400 A60000C ESG-410 * All electrosurgical generators satisfying the interface requirements can be connected to the HF cable. For non- Olympus electrosurgical generators, refer to the below interface requirements.
Page 62 Compatible equipment HF cable Interface requirements for electrosurgical generators (non-Olympus) A60000C Pin diameter: 4 mm (8 mm bushing) Maximum rated voltage: 1000 V Maximum crest factor: 2.0...
Page 63 Compatible equipment A60001C, A60002C, A60003C WA60800C WA64050C WA64120C WA64200C WA60801C WA64210C WA64310C WA64320C WA64360C WA60101C WA64051C WA64121C WA64201C WA64211C WA64311C WA64321C WA64361C WA69410M WA69400M WA69412M WA69414M WA69002M WA69416M WA69003L WA69418M WA69420M WA69422M WA69424M A60002C A60003C UES-30 UES-40 ESG-400 ESG-410 A60001C ESG-410...
Page 64 Compatible equipment * All electrosurgical generators satisfying the interface requirements can be connected to the HF cable. For non- Olympus electrosurgical generators, refer to the below interface requirements. HF cable Interface requirements for electrosurgical generators (non-Olympus) A60001C Pin diameter: 2 × 4 mm (spring basket)
Page 65 UES-30 UES-40 ESG-400 ESG-410 * All electrosurgical generators satisfying the interface requirements can be connected to the HF cable. For non- Olympus electrosurgical generators, refer to the below interface requirements. HF cable Interface requirements for electrosurgical generators (non-Olympus) O0120.1 Pin diameter: 4 mm (spring basket) Maximum rated voltage: 2000 V Maximum crest factor: 6.5...
Page 66 Compatible equipment WA00013A, WA00014A WA00013A UES-40 UES-40S WA22366A WA00014A WA22367A OLYMPUS UNIVERSAL* *Olympus electrosurgical generators with a “Universal” socket...
Page 67: Technical Data
This chapter provides all technical data of the product. The technical data includes information on: – Dimensions – Specifications – Ambient conditions 13.1 Dimensions Catalog number Maximum total length Maximum outer diameter A00010A 4200 mm 3.2 mm A00011A 4200 mm 3.2 mm A00012A 4200 mm 3.2 mm A0335.1...
Page 68: Specifications
Technical data 13.2 Specifications Catalog number Maximum rated voltage Service life A00010A A00011A A00012A A0335.1 A0355 A0357 2000 V A0358 A0391 A0392 12 months A0393 O0120.1 A60000C A60001C A60002C 1000 V A60003C WA00013A WA00014A 13.3 Ambient conditions Operating conditions Ambient temperature ......10 to 40 °C (50 to 104 °F) Relative humidity ............30 to 85%...
Page 69: Glossary
Glossary 14 Glossary Ancillary equipment An equipment that supports and/or extends a device in its function. Applied part An applied part, according to standard IEC 60601-1, is a part of a medical electrical equipment that comes into physical contact with the patient, e.g. an HF instrument. Or, it is that part of an medical electrical equipment through which current can flow between the patient and the medical electrical equipment, e.g.
Page 70 A chemical substance that is used for the rinsing phase of automated cleaning and disinfection to neutralize the microbicidal effect of detergent or disinfectant residues. Qualified service personnel Personnel certified or approved by Olympus to perform certain tasks. Radio-frequency identification Radio-frequency identification (RFID) uses electromagnetic fields to automatically identify and track electronically stored information in devices, e.g.
Page 71 Glossary Thermal disinfection Describes a process of reducing the microorganism of a material to a minimum of 10^-5 (five log steps) by using water with high temperature above 65°C for a certain amount of time. Abbreviation for Unique Device Identifier. The Unique Device Identifier is a label on the medical device with human- and machine-readable information, which allows to uniquely identify the device through distribution and use.
Page 72: Index
Index 15 Index After use ....................32 Ambient conditions ..................68 Attaching the neutral electrode ..............24 Autoclave ....................49 Automated cleaning and thermal disinfection ..........43 Automatic presettings ................30 Before use ....................23 Checking for mechanical defects............24, 46 Checking for performed reprocessing ..........
Page 73 Index Incident reporting ..................10 Inspection .................... 23, 46 Intended purpose ..................8 Intended use ....................8 Intended user ....................9 Manual cleaning ..................40 Manual disinfection ..................42 Manufacturer ....................9 Mechanical defects ................24, 46 Neutral electrode ..................24 Neutralizer ....................
Page 74 Index Safety notes for sterilization............... 48 Safety notes for use ................... 28 Scope of delivery ..................12 Shipment ....................51 Specifications .................... 68 Specific safety notes ..................6 Steam sterilization ..................48 Steam sterilization conditions ..............49 Sterilization ....................48 Storage conditions ..................

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