Related Manuals for Olympus WA91301W
Summary of Contents for Olympus WA91301W
- Page 1 INSTRUCTIONS FOR USE INSTRUCTIONS FOR USE FOOT SWITCH Single pedal Double pedal WA91301W WA91303W...
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Page 3: Table Of Contents
Contents 1 General information ..............5 1.1 User instructions ..............5 1.2 Conventions throughout this document ....... 5 1.3 Safety-related information in this document ......6 2 Safety information ..............8 2.1 Intended purpose ..............8 2.2 Contact ................9 2.3 General safety notes ............ - Page 4 10.2 Shipment ................. 27 10.3 Disposal ................27 11 Compatible equipment ............28 12 Technical data ..............29 12.1 Specifications for WA91301W (double pedal) ....29 12.2 Specifications for WA91303W (single pedal) ....29 12.3 Ambient conditions ............29 13 Index ..................30...
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Page 5: General Information
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... -
Page 6: Safety-Related Information In This Document
General information Element Explanation Numbers with right parenthesis name elements in illustrations 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. - Page 7 General information 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. DANGER Indicates a hazardous situation which, if not avoided, will result in death or serious injury.
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Page 8: Safety Information
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 Foot switch to activate and deactivate the power output of a compatible electrosurgical generator. -
Page 9: Contact
Repair Repair of the product may only be performed by trained qualified servicing personnel that has been authorized by Olympus. Otherwise, Olympus cannot be held responsible for the safety and performance of the product. 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. -
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 "10 Repair, shipment and disposal" on page 26 for more details. Regular safety check... -
Page 11: Product Description
– Warranty information 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) Foot switch (single pedal or double pedal) -
Page 12: Operating Elements
Product description 3.2 Operating elements 3.2.1 Single-pedal foot switch Top view 1) [COAG] pedal, blue To activate the selected coagulation mode. 2) Connection cable with foot switch plug Bottom view 1) Identification plate... - Page 13 Product description 3.2.2 Double-pedal foot switch Top view 1) Connection cable with foot switch plug 2) Toggle button To change the foot switch assignment remotely. 3) [COAG] pedal, blue To activate the selected coagulation mode. 4) Bail handle Engages at 0°, 90°, 180° and 270°. 5) [CUT] pedal, yellow To activate the selected cutting mode.
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Page 14: Symbols
Product description Bottom view 1) Identification plate 3.3 Symbols This section gives an explanation for each symbol used on the product and on the packaging of the product. Symbol Explanation Medical device Serial number Quantity Catalog number Federal (USA) law restricts this device to sale by or on the order of a physician CE marking indicating that the device is in conformity with the applicable requirements... - Page 15 Product description Symbol Explanation Manufacturer Caution, consult accompanying documents Consult instructions for use Unique device identifier Transport conditions Storage conditions Temperature limit Humidity limit In accordance with European Directive on Waste Electrical and Electronic Equipment (WEEE), this symbol indicates that the product must not be disposed of as unsorted municipal waste, but should be collected separately...
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Page 16: Warranty
Product description 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. -
Page 17: Installation
Installation 4 Installation This chapter explains how to install the foot switch. This includes the information on how to place the foot switch correctly. Precondition for installation To avoid accidental activation, the electrosurgical generator must be switched off. Mechanical stress Do not expose the plug-connections to mechanical stress, as this can damage the electrical connections. -
Page 18: Placing The Foot Switch
Installation ► The connection is fixed. 4.2 Placing the foot switch ● Place the foot switch on an even surface. ● Do not place the foot switch in corridors or in areas that people pass during the procedure. -
Page 19: Before Use
Before use 5 Before use This chapter describes all necessary steps to prepare the foot switch for each use. 5.1 Inspection A thorough inspection ensures that the product is fit for use. Damaged products can cause an electric shock and thermal injury. - Page 20 Before use 3. Ensure that the corresponding foot switch indicator is dispalyed on the touchscreen. 4. Press one pedal of the foot switch. 5. Check that the activation tone of the electrosurgical generator sounds. 6. Do not use the foot switch if any kind of problem is observed.
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Page 21: Use
6 Use 6.1 Adapting the foot switch position If the bail handle is engaged in the upright position (90°), it can be used to conveniently move the foot switch by foot to the user’s preferred position. To minimize the risk of tripping, move the bail handle to its down postion (0°) when the foot switch is not in use. -
Page 22: After Use
After use 7 After use This chapter describes all necessary steps that are required to prepare the foot switch for cleaning and disinfection. 7.1 Disconnecting 1. Switch off the electrosurgical generator. 2. At the foot switch plug, pull back the outer sleeve of the connector and demate the plug. -
Page 23: Reprocessing
Reprocessing 8 Reprocessing 8.1 General information for reprocessing The reprocessing cycle – Reprocess the product according to the instructions in this chapter. – Reprocess the product before each use. Validated reprocessing methods Validated means that the efficacy of the method or agent has been validated for reprocessing the product as described in this document. -
Page 24: Disinfection
Reprocessing 2. Thoroughly wipe the surfaces of the foot switch until visibly clean. 3. In case of heavy soiling, use additional cloths. 4. Before disinfection, let the surfaces dry or wipe them dry using a lint-free cloth. 8.3 Disinfection Suitable disinfectants Low-level disinfection has been validated with an alkaline disinfectant based on low alcohol (<20%) and quaternary ammonium compounds (Sani-Cloth®... -
Page 25: Storage And Maintenance
Storage and maintenance 9 Storage and maintenance 9.1 Storage The foot switch must be stored according to the environmental conditions as described in the section "12.3 Ambient conditions" on page 29. The energy cart TC-E410 provides a special compartment for storing foot switches. -
Page 26: 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 27: Shipment
10.2 Shipment Contaminated products can cause infection Sending used and contaminated products to Olympus represents a risk of infection. Olympus is entitled to refuse soiled or contaminated products for reasons of safety. Reprocess the product before sending in. If reprocessing will damage the product completely, clean the product as thoroughly as possible and mark it accordingly. -
Page 28: Compatible Equipment
Compatible equipment 11 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 29: Technical Data
Technical data 12 Technical data 12.1 Specifications for WA91301W (double pedal) Dimensions ............. 392 x 231 x 49 mm Weight ................1,600 g Voltage ............max. AC 25 V/DC 60 V Cable length ................4 m Degree of protection (IEC 60529) ..IPX8 (n/a for plug, cable) Expected service life ............ -
Page 30: Index
Index 13 Index Annual safety checks ................25 CAUTION, signal word ................7 Cleaning agents ..................23 Clinical benefits ................... 9 Contraindications..................8 DANGER, signal word ................. 7 Disinfectants ....................24 General safety notes ................... 6 Incident reporting ..................9 Intended use .................... - Page 31 Index Safety alert symbol ..................5 Safety checks .................... 25 Safety messages ..................7 Service centers ..................26 Signal word ....................7 Specific safety notes ................... 6 Storage conditions ..................29 System chart ..................... 28 Toggle button function ................21 Transport conditions ..................
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