Crossfire Footswitch. User Guide

Transcription

1 Crossfire Footswitch User Guide

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3 Contents Warnings and Cautions... 3 Symbol Glossary... 4 Product Description and Intended Use... 6 System Overview...6 Indications/Contraindications...8 Package Contents...8 Compatible Accessories...8 Setup... 9 Operation Cleaning and Maintenance Cleaning...13 Maintenance...13 Technical Specifications Environmental Specifications...14 EN-1

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5 Warnings and Cautions Please read this manual and follow its instructions carefully. The words warning, caution, and note carry special meanings and should be carefully reviewed: Warning Caution Note Warnings indicate risks to the safety of the patient or user. Failure to follow warnings may result in injury to the patient or user. Cautions indicate risks to the equipment. Failure to follow cautions may result in product damage. Notes provide special information to clarify instructions or present additional useful information. To avoid potential serious injury to the user and the patient and/or damage to this device, the user must obey the following warnings. The warranty is void if any of these warnings is disregarded. 1. Read this operating manual thoroughly and be familiar with its contents prior to setting up or using this equipment. 2. Carefully unpack the unit and check for any damage that may have occurred during shipment. If damage is detected, refer to the Service and Claims section in this manual. 3. Use of this device is restricted to qualified health care professionals who have complete knowledge of the use of this equipment and the devices to which it can be connected. 4. DO NOT use the Crossfire system with non-conductive irrigants (e.g. sterile water, air, gas, glycine, etc.). Use only conductive irrigants, such as saline or Ringer s lactate, in order for the system to function properly. 5. Test this equipment prior to using it in a surgical procedure. This unit was fully tested at the factory before shipment; however, it must be tested for proper function in the environment and setup configuration in which it will be used. 6. Attempt no internal repairs or adjustments not specifically detailed in this operating manual. Refer any readjustments, modifications, and/or repairs to Stryker Endoscopy or its authorized representatives. 7. Pay close attention to the care and cleaning instructions in this manual. Failure to follow these instructions may result in product damage. 8. Install this device in an operating room that complies with all applicable IEC, CEC, and NEC requirements for safety of electrical devices. EN-3

6 Symbol Glossary This device and its labeling contain symbols that provide important information for the safe and proper use of the device. These symbols are defined below. Warning Symbols Warning/Caution: See Instructions for Use Hazardous voltage present Electrosurgical unit Equipotentiality Packaging/Labeling Symbols Legal manufacturer Authorized representative in Europe Date of manufacture Atmospheric pressure range Ambient temperature range Relative humidity range Lot number Product number SN Serial Number C U S Denotes compliance to CSA C22.2 No M90, and UL Protected against the effects of temporary immersion in water. Footswitch EN-4

7 COAG CUT This product contains electrical waste or electronic equipment. It must not be disposed of as unsorted municipal waste and must be collected separately. EN-5

8 Product Description and Intended Use The Crossfire Footswitch is a foot-operated remote control used in conjuction with the Crossfire Integrated Arthroscopy system. It enables the user to activate and control the powered shaver handpiece and radio frequency (RF) electrosurgical probe. System Overview The footswitch is part of the Crossfire Integrated Arthroscopy System, which is a combination powered shaver system/electrosurgical generator, intended for use in arthroscopic and orthopedic procedures. Illustrated below, the Crossfire system consists of the following components: EN-6

9 Crossfire Console Acts as a connection hub for the various components of the Crossfire system Powers a motorized shaver handpiece for the mechanical cutting and debridement of bone and soft tissue Generates bipolar radio frequency (RF) energy for the electrosurgical cutting and coagulation of tissue Provides a central user interface for operating the Crossfire system 2. Disposable RF probe Enables RF cutting and coagulation 3. Powered shaver handpiece (and disposable attachments) 4. Crossfire Footswitch (featured in this manual) Enables arthroscopic cutting and debridement Provides remote, foot control of the powered shaver handpiece and RF probe Note: Instructions for use can be found in the following manuals: Crossfire Console: (English) or P11344 (international) Crossfire Footswitch: (English) or P11345 (international) EN-7

10 Indications/Contraindications The Crossfire system is indicated for use in orthopedic and arthroscopic procedures for the knee, shoulder, ankle, elbow, wrist, and hip. The Crossfire System provides abrasion, resection, debridement, and removal of bone and soft tissue through its shaver blade, and the ablation and coagulation of soft tissue, as well as hemostasis of blood vessels, through its electrosurgical probe. Examples of uses of the product include resection, ablation, and coagulation of torn knee cartilage, subacromial decompressioon, and resection of synovial tissue in other joints. The electrosurgical probe is contraindicated for use in procedures where a nonconductive irrigant is used or with patients having cardiac pacemakers or other electronic implants. Package Contents Carefully unpack the Crossfire Footswitch and inspect each of the following components. Report any damaged components to Stryker. (1) Crossfire Footswitch ( ) (1) User guide Compatible Accessories The Crossfire Footswitch is compatible with the following accessories: Crossfire Console Note: Crossfire footswitches are only compatible with Stryker systems and handpieces. EN-8

11 Setup Stryker Endoscopy considers instructional training an integral part of the Crossfire system. Your Stryker Endoscopy sales representative will perform at least one inservice at your convenience to help you set up your equipment and instruct you and your staff on its operation and maintenance. Please contact your local Stryker Endoscopy representative to schedule an in-service after your equipment has arrived. Warning Be sure that no liquid is present between connections to the console and the handpiece. Connection of wet accessories may lead to electric shock or electrical short. Do not thread or twist the cable connector for insertion or removal. It is a push/pull connector and may be damaged by twisting it into or out of place. To avoid damaging the cable, grasp only the handle portion of the cable connector when connecting or disconnecting the cable. Never pull on the cord itself. Connect the footswitch cable to the Crossfire console. The console will display the footswitch icon. EN-9

12 Operation Warning The Crossfire system is intended for use only by licensed medical professionals, properly trained in the use of electrosurgical equipment and techniques. The Crossfire system generates potentially hazardous levels of energy that can result in injury or even death if improperly used. Before using the Crossfire system in an actual procedure, verify that each component is installed and functioning properly. Improper connection may cause arcing or malfunction of the handpiece or console, which can result in injury, unintended surgical effect, or product damage. To avoid risk of fire, do not operate the footswitch in the presence of a flammable anaesthetic mixture with air, oxygen, or nitrous oxide. The RF and shaver handpieces can be controlled by the Crossfire footswitch. The default footswitch controls are shown below. To customize button assignments, contact your Stryker representative. Note: To keep the footswitch clean during use, Stryker recommends using disposable bags (P/N ). Contact your local Stryker representative for ordering information. EN-10

13 Default RF Controls Button I II III A B Function (controls are the same for defaults 1, 2, and 3) Decrease Cut Level Select Handpiece: RF or Shaver Increase Cut Level Cut Coag EN-11

14 Default Shaver Controls Button Function Default 1 Default 2 Default 3 I Jog Select Mode: Oscillate or Forward/Reverse Select Mode: Oscillate or Forward/Reverse II Select Handpiece: Select Handpiece: Select Handpiece: RF or Shaver RF or Shaver RF or Shaver III Select Direction: Select Speed: Select Speed: Forward or Reverse High or Low High or Low A Oscillate (fixed) Oscillate/Reverse (variable) Oscillate/Reverse (fixed) B Forward/Reverse (variable) Oscillate/Forward (variable) Oscillate/Forward (fixed) Note: When using small-joint handpieces, only Default 2 settings are available. No other defaults or user preferences can be applied. EN-12

15 Cleaning and Maintenance Warning To minimize the risk of infection, clean the footswitch prior to the first use and every use thereafter. Use only non-abrasive cleaning agents. Do not disassemble, sterilize, or immerse the Crossfire Footswitch as this can damage the device. Cleaning 1. Disconnect the footswitch from the console. 2. Wipe the outside of the footswitch with a mild detergent and water according to standard hospital practices. 3. Dry the footswitch with a lint-free cloth. Maintenance The footswitch requires no regular maintenance. To store or ship the footswitch, package it in its original packaging. EN-13

16 Technical Specifications Environmental Specifications Operating temperature: 5ºC 40ºC Operating humidity: 30 95% Shipping temperature: -18ºC 60ºC Shipping humidity: 15 90% Classifications IPX 7 Protected against the effects of temporary immersion in water. Component Dimensions Footswitch: 11" L 10.5" W Cables: 15 EN-14

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18 Stryker Endoscopy 5900 Optical Court San Jose, CA USA , European Representative: Regulatory Manager, Stryker France ZAC Satolas Green Pusignan Av. De Satolas Green MEYZIEU Cedex, France Rev E 2009/10