User’s Guide Valleylab FT10 TM FT Series Energy Platform For use with software version 1.
Preface Preface This guide and the equipment it describes are for use only by qualified medical professionals trained in the particular technique and surgical procedure to be performed. It is intended as a guide for using the Covidien Valleylab FT10 FT Series Energy Platform only.
Limited Warranty Limited Warranty Covidien warrants the covered product listed below to be free from defects in material and workmanship for normal use and service for the period(s) set forth below.
Software License Software License Customer hereby acknowledges that Covidien LP and or its affiliates (collectively called “COVIDIEN” herein) owns the entire right, title, and interest in and to the Software, as mat be installed in the Products or Equipment addressed herein or provided separately (“Software”) (including all of the computer code, source and object, comprising the Software and all components and elements thereof), and all associated manuals, drawings, technical information and Documentation
Software License 3.
Software License Software and the remaining warranty, or extended warranty, if any, applicable to the Product or Equipment with which such Software was delivered.
Software License 10. Survival. Sections 2, 3, 4, 8, 9 and this Section 10 shall survive the termination or expiration of these Software License Terms.
Contents Preface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ii Limited Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .iii Software License . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .iv Chapter 1. Overview and General Features The Valleylab FT10 Energy Platform . . . . . . . . . . . . . . . . . . . . . . Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Chapter 3. System Setup Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Unpacking the System. . . . . . . . . . . . . . . . . . . . . . . . . . . . . Before Starting the System . . . . . . . . . . . . . . . . . . . . . . . . . Turning On the VLFT10GEN . . . . . . . . . . . . . . . . . . . . . . . . Turning Off the VLFT10GEN (Normal Power-off) . . . . . . . 3-2 3-2 3-2 3-3 3-3 System Functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Chapter 5. Bipolar Front Panel Bipolar Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2 Rear Panel Bipolar Features. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-3 Bipolar Quick Setup Instructions . . . . . . . . . . . . . . . . . . . . . . . . . 5-3 Bipolar Function Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-4 Bipolar Power Output Modes . . . . . . . . . . . . . . . . . . . . . . . 5-4 Bipolar Default Settings . . . . . . . . . . . . . . . . . . .
Connecting Bipolar Resection Instruments to the Energy Platform . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-6 Bipolar Resection Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-7 Changing the Energy-Delivery Setting. . . . . . . . . . . . . . . . 7-7 Activating a Bipolar Resection Instrument . . . . . . . . . . . . . . . . . 7-7 Incorrect Foot-Pedal Error. . . . . . . . . . . . . . . . . . . . . . . . . . 7-7 After Surgery . . . . . . . . . . . . .
Wireless Fidelity (WiFi) . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-7 Ethernet . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-8 Symbols Used . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-9 Standards and IEC Classifications . . . . . . . . . . . . . . . . . . . . . . Class I Equipment (IEC 60601-1) . . . . . . . . . . . . . . . . . . . Type CF Equipment/Defibrillator Proof (IEC 60601-1, IEC 60601-2-2, and ANSI/AAMI HF18) . . .
Chapter 1 Overview and General Features This chapter provides an overview of the features and functions of the Valleylab FT10 FT Series Energy Platform. Precaution Read the instructions, warnings, and precautions provided with this energy platform and associated accessories before using. Specific instructions for electrosurgical instruments are not included in this manual.
The Valleylab FT10 Energy Platform The Valleylab FT10 Energy Platform Introduction The Valleylab FT10 FT Series Energy Platform (VLFT10GEN) provides RF energy for monopolar and bipolar surgical applications, and tissue-fusion and vessel-sealing applications. It features a touchscreen divided into four sections for viewing and user input of settings and options available for any application. The energy platform automatically detects coded handsets and configures the energy platform accordingly.
The Valleylab FT10 Energy Platform Overview and General Features Front Panel 10 9 FT10 11 8 1 2 3 4 5 6 7 On/Off button ཱ Restore Settings button ི Audio Volume control button ཱི Service/Settings button ུ REM (Return Electrode Monitoring) indicator ཱུ Interface touchscreen ྲྀ REM patient return electrode receptacle ཷ LigaSure™/Bipolar receptacle ླྀ Monopolar 2 instrument receptacle ཹ Monopolar 1 Universal Foot Pedal Port (UFP) receptacle ེ Bipolar instrument receptacle Valleylab FT10 Energy Platfo
The Valleylab FT10 Energy Platform Rear Panel 2 1 3 Monopolar 2 4 Monopolar 1 Bipolar 5 Warning: Risk of Fire. Replace Fuse as Marked 250V, F10.0A (100-127Vac) 250V, F6.3A (220-240Vac) MonopolarMonopolar 2 1 Avertissement: Risque du feu. Remplacez les fusibles comme marqués. 250V, F10.0A (100-127Vac) 250V, F6.
The Valleylab FT10 Energy Platform The VLFT10GEN provides the following modes and settings for a variety of surgical procedures: Monopolar modes Power-Setting Ranges Peak Voltage - PURE Off, 1–300 W 1287 V - BLEND Off, 1–200 W 2178 V 5–85 W 2783 V - SOFT Off, 1–120 W 264 V - FULGURATE Off, 1–120 W 3449 V - SPRAY Off, 1–120 W 3933 V LOW Off, 1–15 W 133 V MEDIUM 16–40 W 214 V HIGH 45–95 W 462 V No power settings 244 V CUT 1–6 742 V COAG 1–6 318 V CUT VALLE
The Valleylab FT10 Energy Platform Monopolar Modes The system produces six modes of monopolar power output. Precaution To provide expected functionality from a hand piece, proper insertion is required. Refer to the alignment dots below the receptacles for proper insertion orientation. CUT Modes PURE CUT provides a clean, precise cut in any tissue with little or no hemostasis. BLEND CUT is a conventional blended waveform that provides slower cutting with simultaneous hemostasis.
The Valleylab FT10 Energy Platform This generator is designed for use with Covidien monopolar instruments. However, monopolar instruments are compatible with the VLFT10GEN if they have a connector that matches the following figure and are rated for peak voltages of at least 3933 V.
The Valleylab FT10 Energy Platform Foot Pedals FT6003 ForceTriad Three-Pedal Footswitch (Monopolar 2 only) E6008 Valleylab Monopolar Footswitch (Monopolar 1, Monopolar 2 with adapter) E6008B Valleylab Monopolar Footswitch (Monopolar 1, Monopolar 2 with adapter) 1017577 6-Pin to 4-Pin Monopolar Footswitch Adapter (Monopolar 2 only) Bipolar Effects Selection of Bipolar effects and power settings is dependent on surgeon preferences, tissue characteristics, accessories selection, and the intended clinical app
The Valleylab FT10 Energy Platform Do not use the FT0501 ForceTriad Bipolar Adapter with Auto Bipolar on the VLFT10GEN. Compatible Bipolar Instruments & Devices The VLFT10GEN is designed for use with Covidien bipolar instruments. However, other bipolar instruments are compatible with the FT10 if their connectors match the following illustration and are rated for peak voltages of at least 531 V. Overview and General Features Precaution Bipolar Utilizes 4 mm banana pins Bipolar with Switching A.
The Valleylab FT10 Energy Platform The following Covidien catalog numbers for bipolar foot pedals are fully compatible with the VLFT10GEN. Foot Pedals E6009 Valleylab Bipolar Standard Footswitch E6009B Valleylab Bipolar Standard Footswitch E6019 Valleylab Bipolar Dome Footswitch Bipolar Resection Bipolar Resection configures the LigaSure/Bipolar receptacle to use bipolar-resection resectoscopes.
The Valleylab FT10 Energy Platform The tissue fusion function has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use this function for these procedures. LigaSure Instruments The LigaSure instruments that complete the VLFT10GEN tissue-fusion system include reusable and single-use instruments for open and laparoscopic procedures. Each reusable instrument requires a corresponding single-use electrode.
The Valleylab FT10 Energy Platform LigaSure with Switching A. Utilizes 4 mm banana pins B. Utilizes 2 mm banana pins The following LigaSure foot pedal is fully compatible with the VLFT10GEN. Foot Pedal LS0300 Tissue Fusion Footswitch, Purple Connection to External Systems The VLFT10GEN can be connected to an external system. For example, connections can be made to enable smoke evacuation or EKG blanking during monopolar activation, or provide argon-enhanced coagulation.
System Conventions The Touchscreen The VLFT10GEN features a user-friendly touchscreen interface to control system functions. The touchscreen is divided into quadrants; each of the four sections is associated with an adjacent instrument receptacle. • Quadrant 1—Settings entered in the touchscreen control an instrument attached to the Monopolar 1 receptacle. • Quadrant 2—Settings entered in the touchscreen control an instrument attached to the Monopolar 2 receptacle.
System Conventions Generator States The appearance of touchscreen components indicates one of the three states of the system. Edit When the system is powered on and no instrument is attached, the instrument controls in the monopolar and bipolar sections can be preset. The following illustration shows monopolar controls edited prior to inserting an instrument.
System Conventions The black background illuminates brightly when the instrument is activated. The following illustration shows the two-button pencil is currently delivering energy for PURE CUT. The mode controls are locked during activation preventing any change in the mode. Power settings can be changed during activation. Overview and General Features Activation System Buttons There are four buttons on the energy platform’s front panel: On/Off Turns system power on and off.
System Conventions Interface Conventions Interface Element Name Description Pop-up window/ menu Pop-up windows and menus appear on screen when user input is needed or requested. Popups close if the user touches anywhere outside of the pop-up window. Up/Down arrows Up and down arrows indicate additional values or selections are available for the current setting. For numeric values, press the up or down arrow to increase or decrease the displayed value.
Chapter 2 Warnings and Precautions for Patient and Operating Room Safety The safe and effective use of electrosurgery depends to a large degree upon factors solely under the control of the operator. There is no substitute for a properly trained and vigilant surgical team. It is important that the operating instructions supplied with this or any electrosurgical equipment be read, understood, and followed. Electrosurgery has been used safely in millions of procedures.
General Warnings and Precautions General Warnings and Precautions Fire/Explosion Hazards Warning Danger - Explosion Hazard Do not use electrosurgery in the presence of flammable anesthetics or oxidizing gases (such as nitrous oxide (N2O and oxygen) or in close proximity of to volatile solvents (such as ether or alcohol). Fire Hazard Do not place active instruments near or in contact with flammable materials (such as gauze or surgical drapes).
General Warnings and Precautions System Setup Warnings and Precautions Warning Electric Shock Hazard Connect the system power cord to a properly grounded power receptacle. Do not use power plug adapters. Electric Shock Hazard When taking measurements or troubleshooting the system, take appropriate precautions, such as using isolated tools and equipment, using the “one hand rule,” etc.
General Warnings and Precautions Warning While using electrosurgery, the user and patient should not be allowed to come into direct contact with grounded metal objects (e.g., surgical-table frame, instrument table, etc.). If this is not possible during certain procedures (e.g., those in which noninsulated head frames are used), use extreme caution to maximize patient safety: • Use the lowest power setting that achieves the desired effect.
General Warnings and Precautions Precaution Inadvertent activation may occur while installing, removing, or bending electrodes. Ensure that the instrument cord is not connected to the VLFT10GEN or that the system is off. Leads connected to the patient should be positioned in such a way that contact with the patient or other leads is avoided because the capacitance between the electrode cable and the patient may result in some local high current densities. 1. U.S. Department of Health and Human Services.
General Warnings and Precautions Important If required by local codes, connect the energy platform to the hospital potential equalization system with an equipotential cable. The operator of the generator may be as far away from the generator as 2 feet (direct product interaction), 5 feet (inside the sterile field), and 13 feet (across the room working with other equipment).
General Warnings and Precautions Notice Make no modifications to the energy platform. Any modifications to the system will void the warranty. When testing RF equipment, follow these test procedures. Keep test leads to the minimum length usable; lead inductance and stray capacitance can adversely affect readings. Carefully select suitable ground points to avoid ground loop error in measurements.
General Warnings and Precautions Precaution Use only instruments that can withstand the maximum output (peak) voltage for each output mode as listed in Chapter 10, Technical Specifications. Using an instrument with a voltage rating that is lower than the maximum output voltage may result in injury to the patient or the operator, or damage to the instrument. Information on voltage ratings for non-Covidien instruments should be obtained from the instrument’s manufacturer.
Warnings and Precautions for Monopolar Procedures Warnings and Precautions for Monopolar Procedures Warning Simultaneously activating suction/irrigation and electrosurgical current may result in increased arcing at the electrode tip, burns to unintended tissues, or shocks and burns to the surgical team. Some surgeons may elect to “buzz the hemostat” during surgical procedures. It is not recommended, and the hazards of such a practice probably cannot be eliminated.
Warnings and Precautions for Monopolar Procedures Warnings and Precautions for Patient Return Electrodes Warning It is not possible to foresee what combination of current and duty cycle may be safely used in every situation—for example, when higher currents and/or longer duty cycles are used on procedures such as tissue lesioning, tissue ablation, tissue vaporization; and procedures where conductive fluid is introduced into the surgical site.
Warnings and Precautions for Monopolar Procedures Important A statement of compatibility from the CQM patient return electrode manufacturer should be obtained prior to the use of a non-Covidien CQM patient return electrode. A patient return electrode is not necessary in bipolar or LigaSure procedures.
Warnings and Cautions for Laparoscopic Procedures Warnings and Cautions for Laparoscopic Procedures Warning For laparoscopic procedures, be alert to these potential hazards: • Laparoscopic surgery may result in gas embolism due to insufflation of gas in the abdomen. • The electrode tip or LigaSure jaws may remain hot enough to cause burns after the electrosurgical current is deactivated.
Warnings and Precautions for Bipolar Procedures Warnings and Precautions for Bipolar Procedures Warning Use of different Covidien cord models or cords from other manufacturers may not achieve proper electrical output for this device, thereby failing to produce the desired clinical effect. For example, Auto Bipolar activation/deactivation settings may not work properly using cords other than those specified by Covidien.
Servicing Warning Fluid in the body cavity should be kept to a minimum during treatment. Conductive fluids (e.g., blood or saline) in direct contact with, or in close proximity to, the instrument may carry electrical current or heat, which may cause unintended burns to the patient. Aspirate fluid from around the instrument jaws before activating the instrument. Do not attempt to seal or cut over clips or staples as incomplete seals may be formed.
Shunt Cords Notice Refer to this system’s service manual for maintenance recommendations, and function and outputpower verification procedures. Do not spray cleaning fluids directly on the generator as damage to the generator may occur. The latest version of the Valleylab FT10 Energy Platform Service Manual is available at www.BioMedConnect.com.
Chapter 3 System Setup This chapter describes how to set up the energy platform, turn it on, and configure system settings. Precaution Read the instructions, warnings, and precautions provided with this energy platform and associated accessories before using. Specific instructions for electrosurgical instruments are not included in this manual.
Setup Setup Unpacking the System Carefully unpack the contents of the shipping container. The container contains the following items: • Valleylab FT10 FT Series Energy Platform • Power cord • First-time setup guide • Quick reference card • User’s guide • DVD with user’s guide translations and service manual • Ethernet cable • Monopolar foot-pedal adapter • Bipolar Resection foot-pedal adapter Before Starting the System Important The VLFT10GEN is intended for use in a hospital environment.
Setup Turning On the VLFT10GEN 1. Turn on the system by depressing the On/Off button on the front panel. Observe the following during the power-on self-test (POST): • The Covidien logo appears on screen. • A status bar indicates authentication activity. • The system revision code appears. • A tone sounds upon completion of the power-on self-test (POST).
System Functions System Functions The VLFT10GEN system functions are accessed from buttons on the front panel: On/Off, Restore, Audio Volume, and Service and Settings. On/Off When the system is plugged into a power source, the On/Off button appears yellow. Turn on power to the energy platform by pressing and holding the On/Off button for 0.25 seconds. After a successful power-on self-test, the On/Off button illuminates green. A tone sounds to signal a successful system power up.
System Functions Audio Volume The VLFT10GEN has five levels of audio volume. Press the audio-volume button on the front panel to view the volume-select menu. The factory setting is as shown with the volume set at it’s highest level. Adjust the volume using the + or - buttons. Dismiss the dialog box by touching the screen outside of the volume menu. The Language Selection menu presents 25 buttons; each labeled with a language available for all software screens and options in the software interface.
Service and Settings Service and Settings The Service and Settings menu is accessed by pressing the gears button on the front panel. The Service and Settings menu displays the generator serial number, IP address (if connected to the network), software version number, and contact information for the Covidien Service Center.
Service and Settings Logs The LOGS button displays the LOGS menu with three options. 1. Touch the LOGS button to view the Logs menu: • EVENTS—A detailed display of all user actions and generator events on the VLFT10GEN • ERROR—A display of all recorded system errors with details • ERROR HISTOGRAM—A summary of how often an error has occurred 2. Touch entries to view available details: • EVENTS—Touch an event entry to view details. Touch BACK to return to the EVENTS screen.
Service and Settings DEMO Mode DEMO mode is used for demonstration of the generator and accessories only. DEMO mode enables monopolar activation through an attached instrument without the use of a REM patient return electrode. When the monopolar surgery is performed clinically, the required return electrode provides a safe path for the current introduced to the patient’s body.
Service and Settings Warning Use of a non-REM return electrode while in DEMO mode does not monitor the quality of pad contact with the patient. Therefore, no warning will be issued from the generator when pad-topatient contact degrades. 5. Touch EXIT DEMO to close DEMO mode and return to the functional monopolar screen. This will enable REM.
Service and Settings Network The Network button allows the technician to select a network connection to the Valleylab Exchange server for service operations. There are 4 ways to connect to the IT network: • Wired Point-to-Point • Wired Automatic • Wired Manual • Wireless Wired Point-to-Point This selection allows the generator to communicate directly with another computer through an Ethernet cable that is connected from the generator to the computer.
Service and Settings Service Menu Items in the Covidien Service menu are specifically for qualified service personnel and are password protected. The password is 423213. The Service Menu button accesses settings for • RF Output Test • Touchscreen Calibration • Energy Calibration • Country Setup • RFID Antenna Control RF Output Test The RF Output Test Screen is used to test the RF output of the generator.
Chapter 4 Monopolar This chapter describes the Monopolar function of the VLFT10GEN. Precaution Read the instructions, warnings, and precautions provided with this energy platform and associated accessories before using. Specific instructions for electrosurgical instruments are not included in this manual.
Front Panel Monopolar Features Front Panel Monopolar Features 2 3 1 4 FT10 6 5 Monopolar 1 Universal Foot Pedal Port (UFP) receptacle ཱ Monopolar 1 touchscreen quadrant ི Monopolar 2 touchscreen quadrant ཱི Monopolar 2 instrument receptacle ུ REM Patient return electrode receptacle ཱུ Return electrode monitoring (REM) indicator 4-2 Valleylab FT10 Energy Platform User’s Guide
Rear Panel Monopolar Features Rear Panel Monopolar Features 2 1 Monopolar 2 Monopolar 1 Bipolar Warning: Risk of Fire. Replace Fuse as Marked 250V, F10.0A (100-127Vac) 250V, F6.3A (220-240Vac) MonopolarMonopolar 2 1 Avertissement: Risque du feu. Remplacez les fusibles comme marqués. 250V, F10.0A (100-127Vac) 250V, F6.
Monopolar Quick Setup Instructions Monopolar Quick Setup Instructions If familiar with the VLFT10GEN, follow this abbreviated procedure to set up the system for monopolar surgery. If more detailed instructions are required, refer to the following sections in this chapter for detailed instructions. 1. Plug the system power cord into the rear panel receptacle. 2. Plug the system power cord into a grounded power outlet. Important Do not plug the system power cord into a power strip or extension cord. 3.
Monopolar Function Overview Monopolar Function Overview Monopolar Power Output Modes The monopolar energy channels can be configured to these modes: PURE CUT, BLEND, VALLEYLAB, SOFT, FULGURATE, and SPRAY. Warning Electric Shock Hazard • Do not connect wet instruments to the system. • Ensure that all instruments and adapters are correctly connected and that no metal is exposed at any connection point. Connect instruments to the proper receptacle.
Foot Pedal Precaution Connect only Covidien foot pedals. Using foot pedals from other manufacturers may cause equipment malfunction or patient injury. See the list of compatible Covidien foot pedals on page 18. Monopolar Foot-Pedal Activation All devices attached to the Monopolar 1 or Monopolar 2 receptacle—whether handswitching or foot-pedal-activated accessories—can be controlled with a foot pedal.
Return Electrodes – REM Contact Quality Monitoring System Return Electrodes – REM Contact Quality Monitoring System Notice Only contact-quality-monitoring-system patient return electrodes can be used with the VLFT10GEN.
Return Electrodes – REM Contact Quality Monitoring System A REM alarm sounds and the system stops producing output power when either of the following occurs: • The measured resistance is below 5 Ω or above 135 Ω, the limits of the standard range of safe resistance. • An increase in contact resistance is greater than 40% from the baseline measurement. Patient Return Electrode Setup The REM icon appears on the main screen each time the FT10 system is started.
Return Electrodes – REM Contact Quality Monitoring System Warning Do not cut a patient return electrode to reduce its size. Patient burns due to high-current density may result. 1. Select a well vascularized, convex area in close proximity to the surgical site for electrode application. Avoid scar tissue, bony prominences, excessive adipose tissue, and areas where fluid may pool. 2. The patient return electrode site should be free of excessive hair.
Monopolar Electrodes REM Alarm (Visual and Audible) If the REM system senses an alarm condition during the activation of an instrument, RF power delivery stops. An error message is displayed on the touchscreen and two audible warnings sound. The indicator below the screen illuminates red. When the alarm condition has been corrected, the error message closes and the REM LED illuminates green.
Monopolar Electrodes Standard Monopolar Mode Functionality Monopolar settings can be selected for an instrument by three methods: • User Input - Modes and power levels are selected before attaching the instrument. • Automatic - Settings are selected by the system when an attached instrument is identified. Most Automatic settings override Preset settings. • Restore Settings - Using the Restore Settings button to reset the system to the settings in use when the system was last powered down.
Monopolar Electrodes Monopolar Default Settings Monopolar Instrument Default PURE CUT (CUT mode) and FULGURATE (COAG mode) Two-button Pencil Power setting defaults to disabled (--) PURE CUT, VALLEYLAB, COAG Force TriVerse Power setting is 1 power bar CUT mode is on (enabled) Restore to the Last Settings Used Use the Restore button to enter the settings when the system was last powered down. The Restore button can be used prior to and after insertion of the instrument. 1. Press the Restore button.
Monopolar Electrodes When an instrument with VALLEYLAB-mode capability is attached to the Monopolar 2 receptacle, the energy platform detects the instrument type and changes the screen from the default two-button to the corresponding screen.
Monopolar Electrodes Using a VALLEYLAB-Mode Instrument 1. Select the desired power level by touching the up and down arrows on the poweroutput mode. A brief double tone sounds. Power output is displayed in watts. The power level cannot be changed during instrument activation. Warning The power-selecting slider, if available on the instrument, increases and decreases power output. Verify the slider position prior to activation. 2. Activate power output by pressing the desired button on the instrument.
After Surgery After Surgery Disconnect the instruments 1. Turn off the energy platform. 2. Disconnect all instruments from the front panel. 3. Dispose of the instrument according to the procedures for your institution. 4. Disconnect and store any foot pedals used. 5. Disconnect the power plug from the wall receptacle by pulling the plug, not the cable.
Chapter 5 Bipolar This chapter describes the Bipolar function of the VLFT10GEN. Precaution Read the instructions, warnings, and precautions provided with this energy platform and associated accessories before using. Specific instructions for electrosurgical instruments are not included in this manual.
Front Panel Bipolar Features Front Panel Bipolar Features FT10 1 3 2 Bipolar receptacle ཱ Bipolar touchscreen quadrant ི Bipolar settings button 5-2 Valleylab FT10 Energy Platform User’s Guide
Rear Panel Bipolar Features 1 Monopolar 2 Bipolar Rear Panel Bipolar Features Monopolar 1 Bipolar Warning: Risk of Fire. Replace Fuse as Marked 250V, F10.0A (100-127Vac) 250V, F6.3A (220-240Vac) MonopolarMonopolar 2 1 Avertissement: Risque du feu. Remplacez les fusibles comme marqués. 250V, F10.0A (100-127Vac) 250V, F6.
Bipolar Function Overview Bipolar Function Overview Delicate tissue requires less energy to desiccate. The VLFT10GEN provides low-voltage, continuous current for faster dessication without sparking. The possibility of sparking increases as desiccated tissue becomes more resistant to energy flow. The system protects against sparking by limiting the bipolar voltage at relatively high levels of tissue impedance.
Foot Pedal The VLFT10GEN in Bipolar mode can accommodate a three-pin, single-pedal bipolar foot pedal. Bipolar Foot Pedal If pedal activation is to be used with a bipolar instrument, attach the bipolar foot-pedal connector to the Bipolar foot-pedal receptacle on the rear panel. Warning Use only Covidien foot pedals. Use of other manufacturer’s foot pedals is not recommended; unexpected output may occur.
Auto Bipolar Function 2. Touch the ammeter ON/OFF switch to enable the visual ammeter and audio ammeter tones for Bipolar procedures. 3. Touch OK to close the ammeter settings window and retain any changes. The visual ammeter is added to the Bipolar screen and the audio and visual feedback is in use during Bipolar activation. Ammeter settings are retained in the Bipolar quadrant until the system is powered down.
Auto Bipolar Function 1. Access Bipolar settings by touching the settings button in the Bipolar quadrant. The Bipolar settings appear with the default Auto Bipolar setting OFF Bipolar Enable/Disable Auto Bipolar 2. Touch the AUTO ON/OFF switch. 3. A confirmation screen appears over the Bipolar quadrant. Touch Yes to enable, or No to reject. When confirmed, the Bipolar settings reappear with Auto Bipolar set to ON. Important When Auto Bipolar is turned ON, the ammeter setting option disappears.
Auto Bipolar Function Warning Use of different Covidien cord models or cords from other manufacturers may not achieve proper electrical output for this device, thereby failing to produce the desired clinical effect. For example, Auto Bipolar activation/deactivation settings may not work properly using cords other than those specified by Covidien. Setting the Auto Bipolar Activation Delay Specify a delay between the instrument’s initial contact with tissue and delivery of bipolar energy. 1.
Shutting Down Bipolar Functions The Auto Bipolar settings can be exited quickly to change non-setting controls in response to the surgeon’s needs. Any of the following actions closes the window and reopens it with the last saved settings.
Chapter 6 LigaSure This chapter describes how to set up and operate the LigaSure tissue-fusion function of the VLFT10GEN. Precaution Read the instructions, warnings, and precautions provided with this energy platform and associated accessories before using. Specific instructions for electrosurgical instruments are not included in this manual.
Front Panel LigaSure Features Front Panel LigaSure Features 4 3 FT10 2 1 LigaSure quadrant ཱ LigaSure/Bipolar receptacle ི Monopolar 2 quadrant (for LigaSure dual-plug instruments) ཱི Monopolar 2 receptacle (for LigaSure dual-plug instruments) Rear Panel LigaSure Features 1 Monopolar 2 Monopolar 1 Bipolar Warning: Risk of Fire. Replace Fuse as Marked 250V, F10.0A (100-127Vac) 250V, F6.3A (220-240Vac) MonopolarMonopolar 2 1 Avertissement: Risque du feu. Remplacez les fusibles comme marqués.
LigaSure Quick Setup Instructions LigaSure Quick Setup Instructions If you are familiar with the VLFT10GEN, follow this abbreviated procedure to setup the system for LigaSure tissue fusion. The following instructions are for a single-plug instrument, which covers most LigaSure devices. For devices that have two plugs and provide both LigaSure and monopolar functionality, see Connecting Dual-Plug LigaSure Instruments on page 6-8.
LigaSure Function Overview LigaSure Function Overview LigaSure tissue fusion can be used on arteries, veins, and lymphatics, up to and including, 7 mm in diameter and tissue bundles. This system provides precise energy delivery and electrode pressure to tissues for a controlled time period to achieve a complete and permanent fusion of tissues and vessel lumens. The system has been designed to produce minimal sticking, charring, or thermal spread to adjacent tissue.
LigaSure Function Overview LigaSure Default Settings Output or Instrument Default LigaSure Handswitching—enabled (On) LF5544 Pistol Grip • MONOPOLAR mode—VALLEYLAB – LF5637 and LF5644 15 W • MONOPOLAR mode—VALLEYLAB • Monopolar power CUT—15 W – VALLEYLAB—15 W – COAG—15 W LigaSure – LigaSure/Bipolar Receptacle The LigaSure/Bipolar receptacle is located adjacent to the lower-right quadrant of the screen.
LigaSure Instruments Foot Pedal A single-pedal LigaSure foot pedal can be used when the energy platform is using the LigaSure quadrant. LigaSure Instruments Reusable-Instrument Assembly To prepare the reusable LigaSure instruments for use in a procedure, refer to the following steps for the general preparation. To find detailed directions for each instrument, refer to the individual instrument instructions that accompany the instrument electrode. 1.
LigaSure Instruments If applicable, refer to the following sections: • Hand-Activation ON/OFF Switch on page 6-9 • Invalid Instrument on page 6-9 Connecting Single-Plug LigaSure Instruments There are multiple instrument designs, but the general LigaSure-instrument connection process is the same for LigaSure instruments with a single purple LigaSure connector. For devices that have two plugs and provide both LigaSure and monopolar functionality, see Connecting Dual-Plug LigaSure Instruments on page 6-8.
LigaSure Instruments Connecting Dual-Plug LigaSure Instruments 6 5 7 4 2 3 1 LigaSure connector (purple) ཱ LigaSure/Bipolar instrument receptacle ི Monopolar connector (blue) ཱི Monopolar 2 instrument receptacle ུ LigaSure touchscreen quadrant ཱུ Monopolar 2 touchscreen quadrant ྲྀ REM patient return electrode Setup 1. With the bar code on the purple LigaSure connector (1) facing up, firmly insert it into the LigaSure/Bipolar receptacle (2) next to the LigaSure touchscreen quadrant (5). 2.
LigaSure Instruments Hand-Activation ON/OFF Switch Some LigaSure instruments cause the hand-activation icon to appear in the lower left corner of the LigaSure control panel. The hand-activation switch toggles between the ON and OFF setting. For example, the LF1212 Curved, Small Jaw, Open Sealer/Divider, is a LigaSure instrument that can be used with hand-activation on or off. When hand-activation is off, a foot pedal is used to initiate energy delivery.
Activating the LigaSure Instrument Activating the LigaSure Instrument 1. Fully grasp the target tissue in accordance with the LigaSure instrument’s IFU. 2. Activate the LigaSure instrument either by pressing and holding the activation button on the instrument or by depressing the foot pedal. During instrument activation, the LigaSure quadrant of the display illuminates purple and rotates clockwise, and an activation tone sounds for the duration of energy delivery. 3.
Activating the LigaSure Instrument Incomplete Seal Cycle - Short The generator detected a short circuit between the LigaSure jaws—possibly due to contact with a metal object or excess fluid around the surgical site. 1. Release the foot pedal or handswitch button. 2. Check for metal clips or staples. LigaSure If this message appears the user should 3. Reposition the instrument to avoid contact with metal. 4. Remove excess fluids from the surgical site. 5. Reactivate the seal cycle.
After Surgery Incomplete Seal Cycle - Time Out Additional time and energy are needed to complete the seal cycle. If this message appears, the user should 1. Release the foot pedal or activation button. 2. Open the instrument jaws and inspect for a successful seal. 3. Remove excess fluids from the surgical site. 4. Clean and dry the LigaSure jaws. 5. Regrasp the tissue. 6. Reactivate the seal cycle. After Surgery Disconnect the instruments 1. Turn off the energy platform. 2.
Chapter 7 Bipolar Resection This chapter describes how to set up and operate the Bipolar Resection application on the energy platform. For information about setting up and using the Bipolar Resection application, refer to these documents: • This chapter. • ForceTriad Bipolar Resection Footswitch Instructions for Use (FT6009) - Instructions for the only foot pedal that supports Bipolar Resection mode.
Front Panel Bipolar Resection Features Front Panel Bipolar Resection Features FT10 2 1 LigaSure/Bipolar receptacle ཱ Bipolar Resection quadrant (appears upon insertion of Bipolar Resection instrument) Rear Panel Bipolar Resection Features 1 Monopolar 2 Monopolar 1 Bipolar Warning: Risk of Fire. Replace Fuse as Marked 250V, F10.0A (100-127Vac) 250V, F6.3A (220-240Vac) MonopolarMonopolar 2 1 Avertissement: Risque du feu. Remplacez les fusibles comme marqués. 250V, F10.0A (100-127Vac) 250V, F6.
Bipolar Resection Function Overview Bipolar Resection Function Overview Certain urology and gynecology procedures use resection electrodes in a saline environment requiring high bipolar-power outputs to obtain resection and hemostasis performance.
Bipolar Resection Function Overview Bipolar Resection Default Settings Output or Instrument Default Bipolar Resection • CUT effect—1 • COAG effect—1 Warning Electric Shock Hazard • Do not connect wet instruments to the energy platform. • Ensure that all instruments are correctly connected and that no metal is exposed at any connection point. Connect instruments to the proper receptacle. Improper connection may result in inadvertent instrument activation or other potentially hazardous conditions.
Bipolar Resection Function Overview Foot Pedal The LigaSure/Bipolar foot-pedal receptacle is located on the rear panel of the energy platform. Monopolar 2 Monopolar 1 1 Bipolar LigaSure/Bipolar foot-pedal receptacle When Bipolar Resection is in use, a single dual-pedal Bipolar Resection Footswitch can be attached to the LigaSure/Bipolar foot-pedal receptacle using a 1060355 adapter.
Bipolar Resection Function Overview Connecting Bipolar Resection Instruments to the Energy Platform Warning Malfunction may be caused by a loose or incorrect connection of the cord to the energy platform or instrument. Worn cords cannot be repaired. Replace cords on a routine basis to maintain optimum functionality and reliability in operating-room use. Connect accessories to the proper receptacle. Improper connection of accessories may result in potentially hazardous conditions.
Bipolar Resection Settings Bipolar Resection Settings Changing the Energy-Delivery Setting Warning Confirm proper power or intensity settings before proceeding with surgery. Touch either the up or down arrows to increase or decrease the effect setting by one. The effect setting does not advance from 6 to 1 when touching the up arrow or from 1 to 6 when touching the down arrow. Instead a warning tone sounds indicating the minimum or maximum effect setting has been reached.
After Surgery After Surgery Disconnect the Instruments 1. Turn off the energy platform. 2. Disconnect the Bipolar Resection cord from the LigaSure/Bipolar receptacle from the front panel. 3. Disconnect the instrument from the cord. • If the instrument is single-use only (disposable), dispose of it according to the procedures for your institution. • If the instrument is reusable, clean and sterilize it according to the manufacturer’s instructions for use.
Chapter 8 Troubleshooting Precaution Read the instructions, warnings, and precautions provided with this energy platform and associated accessories before using. Specific instructions for electrosurgical instruments are not included in this manual.
General Troubleshooting Guidelines General Troubleshooting Guidelines If the VLFT10GEN malfunctions, check for obvious conditions that may have caused the problem: • Check the system for visible signs of physical damage. • Make sure the fuse drawer is tightly closed. • Verify that all cords are connected and attached properly. • If an error code is displayed on the touchscreens, note the code along with all information on the error screen and use the information in this chapter to proceed.
Correcting Malfunctions 3. Verify that there is full contact between the patient and return electrode. Follow the instructions for use provided with the REM Polyhesive patient return electrode to ensure proper attachment. 4. If the REM alarm persists, it may be necessary to use more than one patient return electrode. Refer to the troubleshooting flow chart in the REM Polyhesive patient return electrode instructions for use for more detail.
Correcting Malfunctions Situation Possible Cause Solution System is on, but did not complete the self-test. Software malfunction. Turn off the energy platform, then turn on. Internal component malfunction. Note the code along with all information on the error screen. Note the number and refer to System Alarms on page 8-9. Use a backup energy platform. Contact your biomedical engineering department or a Covidien technical service representative for assistance.
Correcting Malfunctions Situation CHECK LIGASURE INSTRUMENT pop-up screen appears, a fourpulsed tone sounds, and RF output is disabled. Possible Cause Solution System does not detect monopolar instrument. Firmly insert the monopolar connector into the appropriate receptacle on the energy platform front panel. Ensure the associated monopolar quadrant indicates that it has detected the instrument. System does not detect bipolar instrument.
Correcting Malfunctions Situation Possible Cause Solution REACTIVATE LIGASURE pop-up screen appears, a four-pulsed tone sounds, and RF output is disabled. The seal cycle was interrupted before completion. Reactivate the seal cycle without removing or repositioning the instrument. The handswitch or foot pedal was released before the end tone activated. The jaws were opened before the end tone activated. Additional time and energy are needed to complete the fusion cycle.
Correcting Malfunctions Situation Possible Cause Solution Interference with other devices only when the energy platform is activated. Metal-to-metal sparking. Check all connections to the energy platform, patient return electrode, and instruments. High settings used for FULGURATION. Use lower power settings for FULGURATION. Electrically inconsistent ground wires in the operating room. Verify that all ground wires are as short as possible and go to the same grounded metal.
Correcting Malfunctions Situation Possible Cause Solution Pacemaker interference. Intermittent connections or metal-to-metal sparking. Check the active and patient return electrode cord connections. It may be necessary to reprogram the pacemaker. Current traveling from active to return electrode during monopolar electrosurgery is passing too close to pacemaker.
Correcting Malfunctions System Alarms Most system alarms require some action on the user’s part to correct the condition; however, some are corrected automatically. Use the following list to determine how to correct an alarm condition. After correcting the alarm condition, verify that the system completes the self-test as described in Chapter 3, System Setup.
Correcting Malfunctions 8-10 Error Code Error Title Description Alarm Type Clearing Condition E208 SYSTEM ERROR Stack Overflow High Alarm Power on reboot, successful POST E209 SYSTEM ERROR DMA Failure High Alarm Power on reboot, successful POST E210 SYSTEM ERROR Thread Limit Error High Alarm Power on reboot, successful POST E211 SYSTEM ERROR Internal Messaging Error High Alarm Power on reboot, successful POST E212 SYSTEM ERROR PCBA Failure E213 SYSTEM ERROR SR PCBA Failure H
Correcting Malfunctions Error Title Description Alarm Type Clearing Condition E225 SYSTEM ERROR Processor Watchdog Error High Alarm Power on reboot, successful POST E226 SYSTEM ERROR FPCA Comm Error High Alarm Power on reboot, successful POST E227 SYSTEM ERROR REM Circuit Failure High Alarm Power on reboot, successful POST E228 SYSTEM ERROR Relay Feedback Failure High Alarm Power on reboot, successful POST E229 SYSTEM ERROR Connector Diagnostic Failure High Alarm Power on reboot
Correcting Malfunctions 8-12 Error Code Error Title Description Alarm Type Clearing Condition E242 SYSTEM ERROR RF Data Timing Error High Alarm Power on reboot, successful POST E243 SYSTEM ERROR RF Data Delay Error High Alarm Power on reboot, successful POST E244 SYSTEM ERROR RF Interrupt Error E246 SYSTEM ERROR HWC Control Selection Error High Alarm Power on reboot, successful POST E247 SYSTEM ERROR PS PCBA Failure High alarm Power on reboot, successful POST E248 SYSTEM ERROR
Correcting Malfunctions Error Code Error Title Description Alarm Type E310 TOUCHSCREEN ERROR Unintentional Screen Input Medium Alarm E312 INTERNAL CHECK Absolute Integrated Error Medium Alarm Reactivation, User acknowledge, Enter Service E313 INTERNAL CHECK Voltage Sensor Compare Error Medium Alarm Reactivation, User acknowledge, Enter Service E314 INTERNAL CHECK Current Sensor Compare Error Medium Alarm Reactivation, User acknowledge, Enter Service E315 INTERNAL CHECK Power Sensor
Correcting Malfunctions 8-14 Error Code Error Title Description Alarm Type Clearing Condition E326 CHECK INSTRUMENT N/A Medium Alarm Switch release, Remove instrument E327 CHECK FOOT PEDAL N/a Medium Alarm Pedal release E328 UNINTENTIONAL INPUT Panel Button Error Medium Alarm Button release E329 CHECK FOOT PEDAL Invalid Foot Pedal Input Medium Alarm Condition clears E330 PROLONGED ACTIVATION Prolonged Activation Medium Alarm User acknowledge, Enter Service, Reactivation E331
Correcting Malfunctions Error Title Description Alarm Type Clearing Condition E342 INTERNAL CHECK Foot Pedal Comm Issue Medium Alarm Condition clears, User acknowledge, Enter Service E343 INTERNAL CHECK REM Comm Issue Medium Alarm Condition clears, User acknowledge, Enter Service E344 INTERNAL CHECK REM Comm Issue Medium Alarm Condition clears, User acknowledge, Enter Service E345 INTERNAL CHECK REM Comm Issue Medium Alarm User Acknowledge, Enter Service E346 INTERNAL CHECK REM Co
Correcting Malfunctions 8-16 Error Code Error Title Description Alarm Type Clearing Condition E401 AUTHORIZATION ISSUE Invalid Pairing Code Low Alarm User acknowledge, Enter Service E402 INCOMPLETE SEAL CYCLE N/A LigaSure Alarm Reactivation, Remove instrument, User acknowledge, Enter Service, Install instrument E403 INCOMPLETE SEAL CYCLE N/A LigaSure Alarm Reactivation, Remove instrument, User acknowledge, Enter Service E404 INCOMPLETE SEAL CYCLE N/A LigaSure Alarm Reactivation, Re
Correcting Malfunctions Error Code Error Title Description Alarm Type Clearing Condition E415 FEATURE NOT ENABLED N/A Medium Alarm Remove instrument, Enter Service, Dismiss message (select Okay or Cancel) E416 UNKNOWN INSTRUMENT N/A Medium Alarm Remove instrument E417 INVALID INSTRUMENT N/A Medium Alarm Remove instrument E419 Incomplete Setup N/A Low Alarm Remove instrument.
Chapter 9 Maintenance and Repair This chapter presents the following information: • The manufacturer’s responsibility • Routine maintenance and safety checks • Cleaning the energy platform • Product service • Service manual copies and updates • Returning the energy platform for service • Software updates • Covidien Technical Service • Training and education Precaution Read the instructions, warnings, and precautions provided with this energy platform and associated accessories before usin
Responsibility of the Manufacturer Responsibility of the Manufacturer Covidien is responsible for the safety, reliability, and performance of the energy platform only if all of the following conditions have been met: • Installation and setup procedures in this manual are followed. • Assembly, operation, readjustments, modifications, or repairs are carried out by persons authorized by Covidien.
Cleaning Warning Shock Hazard Before cleaning or servicing the unit, disconnect the power plug from the power outlet in order to completely isolate the generator from mains power. Notice Maintenance and Repair Cleaning Do not clean the energy platform with abrasive cleaning or disinfectant compounds, solvents, or other materials that could scratch the panels or damage the energy platform. Do not spray cleaning fluids directly on the generator as damage to the generator may occur. 1.
Product Service Returning the Energy Platform for Service Before returning the energy platform, call a Covidien sales representative for assistance. If the energy platform is to be sent to Covidien, do the following: 1. Obtain a return authorization number. Call the Covidien Technical Service Center (see page 9-6) to obtain a Return Authorization Number.
Software Updates Software updates are available directly from Covidien by using the Valleylab Exchange Remote Software System application. Go to www.covidien.com/valleylabexchange to download and install the latest version of the Valleylab Exchange application. For additional information, the Valleylab Exchange Remote Software System User’s Guide is available on the Valleylab Exchange website.
Service Manual Copies and Updates 12. On the facility computer, open the Valleylab Exchange application. Valleylab Exchange prompts the user to put the energy platform in service mode. 13. Select the software version from Valleylab Exchange to be installed on the energy platform. The software upgrade will start. 14. Confirm the start of the software upgrade on the generator touchscreen. A progress bar on the generator will inform you that the software update is in process. 15.
Training/Education For clinical professionals and service training options, please refer to the Covidien web site: http://www.covidien.
Chapter 10 Technical Specifications Precaution Read the instructions, warnings, and precautions provided with this energy platform and associated accessories before using. Specific instructions for electrosurgical instruments are not included in this manual.
VLFT10GEN Specifications VLFT10GEN Specifications General Output configuration Isolated output Cooling Natural convection and fan Display 7 in. LCD touchscreen Connector receptacles LED illuminated connector readers on the LigaSure/Bipolar receptacle Enclosure Magnesium Mounting • Valleylab Universal Generator Cart (VLFTCRT) • Operating-room boom systems • Any stable, flat surface such as a table or cart top Operating System Linux™* Dimensions and Weight 10-2 Height 7.0 in. (17.
VLFT10GEN Specifications Environmental Parameters Transport and Storage 1,2 Ambient temperature range 50 to 104 °F (10 to 40 °C) 14 to 140 °F (-10 to +60 °C) Relative humidity 30% to 75% non-condensing 25% to 85% non-condensing Atmospheric pressure 700 to 1060 millibars 500 to 1060 millibars 1. The system can be stored for up to one year without performance degradation upon use. 2.
VLFT10GEN Specifications Power Cord Specifications This system is factory equipped with a 110 VAC hospital grade NEMA 5-15 power cord. Should the AC power cord need to be replaced to match another plug configuration, the replacement plug/cable/receptacle configuration must meet or exceed the following specifications: • 100-120 VAC Cable - SJT16/3, IEC color code, maximum length 15 ft.
VLFT10GEN Specifications Internal Memory Storage capacity 8 GB Duty Cycle The VLFT10GEN is capable of operating a duty cycle of 25%, defined as 10 seconds active and 30 seconds inactive, in any mode for a period of four hours. Use of duty cycles greater than 25% (10 seconds active followed by 30 seconds inactive) will increase the risk that heat build-up under a return electrode may be high enough to injure the patient. Do not continuously activate for longer than one minute.
VLFT10GEN Specifications Radio Frequency Identification (RFID) The RFID module is located above the LigaSure/Bipolar receptacle. The intended use of the RFID module is to identify the inserted LigaSure instrument and configure the generator with the data included in the RFID tag. 10-6 Transmit/Receive Frequency Range 13.56MHz RF Output Power 68.
VLFT10GEN Specifications Wireless Fidelity (WiFi) The WiFi module is located on the back of the generator. The intended use of the WiFi module is to perform service operations on the generator. Transmit/Receive Frequency Range 2.4000 ~ 2.4835 GHz (Industrial Scientific Medical Band) IEEE 802.11b, 802.11g, 802.11n RF Output Power 11b: 17 ± 1.5 dBm 11g: 15 ± 1.5 dBm 11n: 14 ± 1.5 dBm Data Rate 11b: 1/2/5.
VLFT10GEN Specifications RF Exposure Statement This device meets the requirements for RF exposure when operated at a minimum distance of 20 cm from the user or nearby persons. EU Declaration of Conformity Hereby, Covidien llc, declares that this wireless LAN and RFID are in compliance with the essential requirements and other relevant provisions of Directive 1999/5/EC.
Symbols Used Symbols Used For prescription use only Consult instructions for use Caution: Consult accompanying documents The energy platform output is floating (isolated) with respect to ground. Technical Specifications Follow instructions for use (blue) Defibrillation proof DANGER Explosion risk if used with flammable anesthetics To reduce the risk of electric shock, do not remove the cover. Refer servicing to qualified service personnel.
Symbols Used 3164410 Conforms to ANSI/AAMI std. ES60601-1:2005 Conforms to IEC std. 60601-2-2 Ed. 5 2009 IP21 Classified with respect to electrical shock, fire, and mechanical hazards only in accordance with AAMI ES standard 60601-1; certified to CSA standard C22.2 60601-1:2008.
Standards and IEC Classifications Foot pedal Volume adjustment for activation tones Equipotential grounding point Do not reuse (Single use only) Technical Specifications Equipment should not be disposed in trash Standards and IEC Classifications The VLFT10GEN meets all pertinent clauses of the IEC 60601-1 editions 2.0 and 3.1, IEC 60601-2-2 editions 4.0 and 5.0, IEC 60601-1-2 editions 2.1 and 3.0 and 4.0, and IEC 60601-1-8 edition 2.1.
Standards and IEC Classifications IP21 Liquid Ingress/Spillage (IEC 60601-1 and IEC 60601-2-2) The VLFT10GEN is constructed so that liquid spillage in normal use does not wet electrical insulation or other components which when wetted are likely to adversely affect the safety of the equipment.
Standards and IEC Classifications Notice The system intentionally applies RF energy for diagnosis or treatment during activation. Observe other electronic medical equipment in the vicinity during the system activation for any possible adverse electromagnetic effects. Ensure adequate separation of electronic medical equipment based on observed reactions.
Standards and IEC Classifications Guidance and manufacturer’s declaration - electromagnetic immunity The Valleylab FT10 FT Series Energy Platform is intended for use in the electromagnetic environment specified below. The customer or the user of the Valleylab FT10 FT Series Energy Platform should assure that it is used in such an environment.
Standards and IEC Classifications Guidance and manufacturer’s declaration - electromagnetic immunity a. 1 cycle is at 50 Hz or 20 ms NOTE: UT is the a.c. mains voltage prior to the application of the test level.
Standards and IEC Classifications Guidance and manufacturer’s declaration - electromagnetic immunity NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people. a.
Standards and IEC Classifications Recommended separation distances between portable and mobile RF communication equipment and the Valleylab FT10 FT Series Energy Platform Frequency ranges and text condition on transmitter bands Test Frequencies (MHz) Modulation Claimed Compliance Level V/m 380 – 390 385 Pulsea – 18 Hz 27 430 – 470 450 FM ± 5 kHz Deviation or Pulsea – 18 Hz 28 704 – 787 710, 745, 780 Pulsea – 217 Hz 9 800 – 960 810, 870, 930 Pulsea – 18 Hz 28 1700 – 1990 1720, 1845, 1970
Standards and IEC Classifications Cables Used for EMC Compliance Testing The following cables, lengths, and instruments were used to determine compliance levels. Model No. Description Shielded Length Location Classification Tests Included 207002060 A/C cable No 15 ft. (4.6 m) Rear panel AC Emissions/ Immunity 1017178 Equipotential cable No 15 ft. (4.6 m) Rear panel EQ Emissions/ Immunity E2450HDB 2-button pencil No 15 ft. (4.
Standards and IEC Classifications Description Shielded Length Location Classification Tests Included Any Ethernet No 15 ft. (4.6 m) min. Rear panel SIP/SOP Emissions/ Immunity SEA3730 Coax No 10 ft. (3 m) Rear panel smoke2 evac. SIP/SOP Emissions/ Immunity SEA3730 Coax No 10 ft.
Standards and IEC Classifications Auto Bipolar The VLFT10GEN is equipped with an Auto Bipolar feature that allows for automatic activation of bipolar energy. Warning Use of different Covidien cord models or cords from other manufacturers may not achieve proper electrical output for this device, thereby failing to produce the desired clinical effect. For example, Auto Bipolar activation/deactivation settings may not work properly using cords other than those specified by Covidien.
Standards and IEC Classifications Audio Tones Activation Tones Tone Duration CUT 660 Hz ± 5% Entire Activation Duration COAG 940 Hz ± 5% Entire Activation Duration VALLEYLAB 800 Hz ± 5% Entire Activation Duration BIPOLAR 940 Hz ± 5% Entire Activation Duration LIGASURE 440 Hz ± 5% Entire Activation Duration Valleylab FT10 Energy Platform User’s Guide Volume User adjustable from 45 dBA to 65 dBA (-0/+6 dBA @ 1 m) Technical Specifications Activation Tones 10-21
Standards and IEC Classifications Alarm Tones Alarm Tones Tone(s) Duration Volume REM 660 Hz ± 5% Two 500 msec. tones separated by 500 msec. of silence Regrasp/ Reactivate High 784 Hz ± 5% Four 175 msec. tones (high, low, high, low) Low 587 Hz ± 5% Seal Cycle Complete 988 Hz ± 5% Two 175 msec. tones separated by 175 msec. of silence High System Alarm Simultaneously play the following tones: Ten 138 msec. tones separated by 88, 88, 312, 88, 825, 88, 88, 312, and 88 msec.
Energy Output Characteristics Notice Alarm characteristics cannot be changed. Alarm response time is less than one second. Energy Output Characteristics Rated Load (Ω) Rated Output Power (W) Peak Voltage Current RMS Max Typical Crest Factor Duty Cycle PURE 300 300 1287 1.25 1.42 100% BLEND 300 200 2178 1 2.5 50% VALLEYLAB 300 200 2783 1 3.8 25% SOFT 100 120 264 1.55 1.42 100% FULGURATE 500 120 3449 1 5.7 6.25% SPRAY 500 120 3933 1 6.5 4.
Energy Output Characteristics Output Waveforms TissueFect Tissue Sensing Technology, an automatic adjustment, controls all modes and effects. As tissue resistance increases from zero, the energy platform outputs constant current, followed by constant power, followed by constant voltage. The maximum output voltage is controlled to reduce capacitive coupling and video interference and to minimize sparking.
Output Power vs. Resistance Graphs LigaSure LIGASURE 434 kHz sinusoid continuous Bipolar Resection BIPOLAR RESECTION 434 kHz sinusoid continuous Technical Specifications Output Power vs. Resistance Graphs For the values stated in the graphs provided in this section: • Output power is within the greater of 15% or 8 W. • Peak voltage includes tolerances.
Output Power vs.
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Output Power vs. Resistance Graphs Peak voltage versus power setting for SPRAY power 1 Open Circuit 2 Peak voltage ཱ Power setting Bipolar Graphs Bipolar LOW Effect Output power versus impedance for Bipolar LOW power 100% 50% 1 2 Output power (watts) ཱ Load impedance (ohms) Note: Bipolar LOW effect is utilized for power settings of Off, 1–15 W inclusive within Bipolar mode (1-95 W).
Output Power vs.
Output Power vs. Resistance Graphs Bipolar MEDIUM Effect Output power versus impedance for Bipolar MEDIUM power 100% 50% 1 2 Output power (watts) ཱ Load impedance (ohms) Note: Bipolar MEDIUM effect is utilized for power settings of 16–40 W inclusive within Bipolar mode (1-95 W).
Output Power vs. Resistance Graphs Peak voltage versus power setting for Bipolar MEDIUM power Open Circuit 1 Technical Specifications 2 Peak voltage ཱ Power setting Bipolar HIGH Effect Output power versus impedance for Bipolar HIGH power 100% 50% 1 2 Output power (watts) ཱ Load impedance (ohms) Note: Bipolar HIGH Effect is utilized for power settings of 45–95 W inclusive within Bipolar mode (1-95 W).
Output Power vs.
Output Power vs. Resistance Graphs LigaSure Output power versus impedance for LigaSure power 1 Output power (watts) ཱ Load impedance (ohms) Technical Specifications 2 Note: The LigaSure Vessel Sealing algorithm is a vessel adaptive algorithm. The LigaSure Vessel Sealing algorithm only requests the power it needs to optimally seal vessels; the power requested will be within the confines of the output power capability curve.
Output Power vs.
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