CELON ELITE ProCut ESU HANDPIECE Instructions for Use Oct 2017

Contents 1 General information... 5 1.1 User instructions... 5 1.2 Signal words... 5 1.3 Conventions throughout this document... 5 1.4 Manufacturer... 6 2 Safety information... 7 2.1 Intended use... 7 2.2 Contraindications... 7 2.3 User qualification... 8 2.4 Environment of use... 8 2.5 General dangers, warnings and cautions... 8 3 Product description... 13 3.1 Scope of delivery... 13 3.2 Symbols... 13 3.3 Handpiece CELON ELITE ProCut... 14 3.4 Non-sterile delivery... 14 3.5 Warranty... 15 4 Preparation... 16 4.1 Safety information for preparation... 16 4.2 Preparing the compatible equipment... 17 4.3 Inspection of the handpiece CELON ELITE ProCut... 18 4.4 Assembly and connection... 18 4.5 Settings on the electrosurgical generator... 19 5 Use... 21 5.1 Safety information for use... 21 5.2 Holding the instruments correctly... 22 5.3 Correct sequence of steps... 22 6 After use... 23 6.1 Disassembly... 23 6.2 Disposal of the cutting electrode... 23

6.3 Preparation for reprocessing at the point of use... 23 7 Reprocessing... 25 7.1 Safety information for reprocessing... 25 7.2 General information for reprocessing... 25 7.3 Compatible reprocessing methods... 26 7.4 Manual cleaning and disinfection... 28 7.5 Automated cleaning and thermal disinfection... 30 7.6 Maintenance... 32 7.7 Sterilization... 33 8 Repair, shipment and disposal... 35 8.1 Repair... 35 8.2 Shipment for warranty returns... 35 8.3 Disposal... 35 9 Compatible equipment... 36 10 Technical data... 37 10.1 Specifications... 37 10.2 Dimensions for reprocessing... 37 10.3 Ambient conditions... 37

General information

1 General information 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 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. This symbol indicates additional helpful information.

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General information 1. A numeration indicates a sequence of actions. 2. 3. • 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 2) 3)

1.4 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 Handpiece CELON ELITE ProCut WB990278 The handpiece is intended to allow electrosurgical removal of soft tissue in ENT/Head and Neck Surgery. 2.1.2 Specific intended use Handpiece CELON ELITE ProCut WB990278 The handpiece is intended to join an electrosurgical cutting electrode and electrosurgical gripping forceps with a compatible Olympus electrosurgical generator. The tissue to be removed is grasped with a gripping forceps which simultaneously functions as the return electrode and is connected to the neutral electrode socket of the electrosurgical generator. The part with the cutting electrode is connected to the monopolar socket of the electrosurgical generator. The handpiece is intended only for the use with a compatible Olympus electrosurgical generator.

2.2 Contraindications Electrosurgical interventions are contraindicated if, in the judgment of the physician, tissue vaporization and coagulation could have a negative effect on the state of the patient. In the case of patients with a weakened immune system or a tendency to bleed (e.g. due to anti-coagulants) the electrosurgical cutting of tissue can be contraindicated.

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Safety information The intended use and contraindications of the equipment used in combination with the handpiece CELON ELITE ProCut 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 reusable products 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 specialized equipment. Reprocessing Reusable products must be reprocessed according to the applicable national and local standards and regulations.

2.5 General dangers, 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 or in the instructions for use of any product being used with this product.

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Safety information WARNING Risk of injury to the patient, the user and 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 25. •• Do not use a product that has not been reprocessed. •• Before each use, inspect the product as described in the chapter “Preparation” on page 16. •• Do not use a damaged product. WARNING Risk of injury to the patient The cutting electrode CelonProCut-Electrode Type1 (WB990177) is for single use only. The cutting electrode is delivered in a sterile condition. Reuse, cleaning, reprocessing, resterilization and improper storing conditions and handling could lead to injury of the patient and the user and malfunction of the product. •• Do not use sterile-packaged products if the packaging has been opened, if the packaging is damaged or if there are other signs of non-sterility. •• Do not use the product after its use by date. •• Open the packaging only immediately before use. •• Do not attempt to clean, reprocess or resterilize disposable products. •• Do not reuse disposable products. •• Only use a product that has been stored under the conditions mentioned on the packaging. •• Do not bend the cutting electrode. CAUTION Risk of injury to the patient If the handpiece falls down the sterility is lost and the handpiece could be damaged. Using a damaged or non-sterile product could result in injury and infection of the patient. •• Do not continue to use the product if it has fallen down. 9

Safety information •• Thoroughly inspect the product for any signs of damage. •• Do not use a damaged product. •• Reprocess the product before the next use. CAUTION Risk of injury to the patient and the user The use of a damaged product or of a product with improper functioning may cause an electric shock and thermal injury. •• Before each use, observe the instructions in the section “Preparation” on page 16”. •• 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 Using the handpiece with other equipment than the compatible equipment could result in burns. •• The handpiece must only be used with the following compatible equipment: -- CelonProCut-Electrode Type1 (WB990177) -- CelonProCut-Gripping Forceps (WB990202) -- Electrosurgical generator CELON ELITE ESG‑200 CAUTION Risk of injury to the patient and the user Unintended current flow may cause injury to the patient and the user. The patient must be insulated against all electrically conductive parts. •• Ground the operating table. •• Make sure that the patient does not come in contact with metal parts, e.g. the operating table. •• Place the patient on a dry, electrically insulating surface. •• Make sure that the patient’s clothes are dry. •• 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. 10

Safety information •• Remove any metallic items from the patient, e.g. wristwatches, jewelry. •• Route all connecting cables so that they are not in direct contact with the patient. •• Route all connecting cables so that they are not in contact with other cables. CAUTION Risk of injury to the patient When using physiological monitoring equipment, then current may flow to the monitoring electrodes and can cause thermal injury where the monitoring electrodes are attached. Especially, the use of needle electrodes can result in burns to the patient. •• Place the physiological monitoring electrodes as far away as possible from the electrodes of the HF instrument. •• Do not use needle monitoring electrodes. •• Use physiological monitoring equipment with HF current limiting measures. CAUTION Risk of injury to the patient Using HF equipment on patients with implanted electronic devices, e.g. cardiac pacemakers or cardioverter defibrillators, can cause failure of the implanted electronic device. Failure of the implanted electronic device will affect the heart and could result in cardiac arrest. •• Prior to the HF procedure, confirm its safety with a cardiologist or the manufacturer of the implanted electronic device. •• Do not apply the HF instrument in close proximity to the implanted electronic device. CAUTION Risk of injury to the patient Using too high power settings could result in burns to the patient. •• The output power level must not set higher than 50 W.

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Safety information CAUTION Risk of injury to the patient If the product becomes brittle and defective a sparkover could cause nerve and muscle stimulation, which could result in injury to the patient. •• Before each use, thoroughly inspect the product for traces of wear. •• Do not use the product if brittle or defective insulation is observed. •• Dispose of the product 12 months after the first use the latest. CAUTION Risk of injury to the user It is safe to use the handpiece CELON ELITE ProCut and its accessories with a maximum output voltage of 700 Vpeak. Using a higher output voltage could result in burns to the user. •• Only use the monopolar cutting modes provided by the compatible electrosurgical generator. •• Do not use an output voltage of more than 700 Vpeak. CAUTION Risk of injury to the patient, the user and the medical personnel The ignition of flammable gases, especially anaesthetics, will cause serious injuries to the patient, the user and the medical personnel. •• Take precautionary measures to keep away flammable gases from the site of intervention. •• Do not use flammable anaesthetics, e.g. nitrous oxygen or oxygen.

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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. WB990278: -- Handpiece CELON ELITE ProCut -- Instructions for use

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

Explanation

Symbol

Explanation

Catalog number ​

Keep away from rain. Keep dry

Batch code

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

Quantity of content

Storage conditions

Manufacturer

Transport conditions

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

Indicates a recovery/recyclable package or package material

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Product description Symbol

Explanation

Symbol

Explanation

Consult instructions for use

In accordance with European Directive 2002/96/EC on Waste Electrical and Electronic Equipment, this symbol indicates that the product must not be disposed of as unsorted municipal waste, but should be collected separately.

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

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

Caution, consult accompanying documents

Duration of use in months

3.3 Handpiece CELON ELITE ProCut

1) 2) 3) 4) 5)

Handle for cutting electrode Connector for gripping forceps Neutral electrode plug Monopolar plug HF cable

3.4 Non-sterile delivery The product is delivered in a non-sterile condition. •• Reprocess the product before first and each subsequent use. 14

Product description •• Refer to the chapter “Reprocessing” on page 25.

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, the user and the medical personnel A wrong identification of the product due to unreadable markings could implicate wrong reprocessing methods. This can cause infection of the patient, the user and the medical personnel as well as damage to the product. •• Before each use, observe the instructions in the section “Inspection of the handpiece CELON ELITE ProCut” on page 18. •• Dispose of the product if the markings on the product become illegible. CAUTION Risk of injury to the patient If the cutting electrode is improperly connected to the handpiece, then the cutting electrode might loosen during the procedure. This could result in stab injury to the patient. •• Before use, make sure that the cutting electrode is properly connected. •• Refer to the section “Assembly and connection” on page 18. CAUTION Risk of injury to the user Assembling the cutting electrode without the protective cover to handpiece could result in injury to the user. •• Before removing the protective cover assemble the cutting electrode to the handpiece. •• Once the cutting electrode is connected and the protective cover is removed, do not disconnect the cutting electrode again, despite for disposal.

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Preparation CAUTION Risk of injury to the patient, the user and the medical personnel For production reasons the product might have defects like rough surfaces and sharp edges or sharp tips. During use these defects can result in stab and cutting injuries. •• Before each use, observe the instructions in the section “Inspection of the handpiece CELON ELITE ProCut” on page 18”. •• Do not use a defective product.

4.2 Preparing the compatible equipment CELON ELITE ESG‑200 •• Refer to the instructions for use of the electrosurgical generator CELON ELITE ESG‑200 for step-by-step instructions regarding the assembly, initial system check and use. CelonProCut-Gripping Forceps •• Refer to the instructions for use of the CelonProCut-Gripping Forceps for preparation and handling of the gripping forceps. CelonProCut-Electrode Type1 •• Do not remove the protective cover before the system is assembled completely. 1. Inspect the packaging of the cutting electrode for integrity of sterility. Do not use the product if there is any damage to the packaging. 2. Inspect the use by date on the label. Do not use the cutting electrode beyond the use by date. 3. Open the packaging only directly before use. 4. Remove the cutting electrode from the packaging. 5. Inspect the cutting electrode for damage. Do not use the product if any damage is visible.

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Preparation

4.3 Inspection of the handpiece CELON ELITE ProCut 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 •• Check that the product has: -- no rough surfaces, sharp edges or sharp tips -- no dents, cracks, kinks, or deformations -- no deep scratches -- no corrosion -- no missing or loose parts -- no brittle or defective insulation •• Check all markings on the product for clear visibility.

4.4 Assembly and connection If force is required to assemble the product, dispose of the product and use another one. 1. Switch on the electrosurgical generator. 2. Connect the monopolar plug to the “Monopolar” socket of the CELON ELITE ESG‑200. 3. Connect the neutral electrode plug to the “Neutral” socket of the CELON ELITE ESG‑200. 4. Plug the CelonProCut-Gripping Forceps into the connector for gripping forceps until it is completely engaged.

5. Plug the CelonProCut-Electrode Type1 into the handle for cutting electrode until it is completely engaged.

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Preparation

6. 7. 8. 9.

Observe the correct direction: The distal tip is under the protective cover. Make sure that the non-insulated part of the cutting electrode is completely covered by the handle. Lay the HF cable in such a way that stumbling or rolling over by chair or bed castors is prevented. Keep hold of the cutting electrode within the handle and remove the protective cover from the cutting electrode. Inspect the cutting electrode for damage. Do not use the product if any damage is visible. CELON ELITE ESG-200

CELON ELITE ESG-200

WB990177

WB990202

WB990278

Completely connected handpiece “CELON ELITE ProCut”

4.5 Settings on the electrosurgical generator The output power must not set higher than 50 W. •• Check the presettings at the electrosurgical generator. 19

Preparation •• Do not choose a setting with an output power level that is higher than 50. •• Olympus recommends to use the modes FineCut or PureCut. •• For more information on selecting appropriate settings refer to the instructions for use of the electrosurgical generator CELON ELITE ESG‑200.

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Use

5 Use 5.1 Safety information for use CAUTION Risk of injury to the patient and the user After deactivation, the cutting electrode remains hot for a while. Unintended contact of the active cutting electrode or the deactivated but hot cutting electrode with non-target tissue or the user’s skin could result in burns. •• Do not contact intact mucous membrane with the active cutting electrode. •• Do not contact intact mucous membrane with the hot cutting electrode. •• Before removing the cutting electrode from the handpiece, wait for a few seconds until the cutting electrode has cooled down. CAUTION Risk of injury to the patient Grasping tissue with the gripping forceps after the cutting electrode is activated could result in burns of the grasped tissue. •• Make sure to use the product correctly as explained in the section “Correct sequence of steps” on page 22. •• Do not use the gripping forceps for grasping tissue other than the target tissue.

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