Endoscopy iSwitch Wireless Universal Foot Control Operation and Maintenance Manual PATENTS PENDING
Table of Contents Table of Contents............................................................................................. 1 Warnings and Cautions .................................................................................. 2 Symbol Definitions ......................................................................................... 3 Product Description / Intended Use ............................................................ 4 The Footswitch ..................................................
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 The personal safety of the patient or physician may be involved. Disregarding this information could result in injury to the patient or physician. Caution Special service procedures or precautions must be followed to avoid damaging the instrument.
7. When the Receiver is interconnected with other medical electrical equipment, leakage currents may be additive. Ensure all systems are installed according to the requirements of IEC 60601-1-1. The Wireless Universal footswitch warranty is void if any of these warnings are disregarded. WARNINGFederal law (United States of America) restricts this device to use by, or on order of, a physician. Stryker Endoscopy reserves the right to make improvements to the product described herein.
Product Description and Intended Use The Stryker Wireless Universal footswitch system is a wireless remote-control system that centralizes control of the various footswitch-operated devices found in the operating room. The iSwitch is intended for use in surgical procedures where footswitch-operated devices, such as the Stryker TPS or SERFAS systems, are normally used.
The Footswitch The footswitch rests on the operating-room floor and provides foot control of all devices connected to the iSwitch system. The footswitch houses three buttons and two pedals, which enable the user to alternate between operating-room devices and perform device-specific functions. When a button or pedal is pressed, the footswitch transmits a radio signal to the receiver, where the command is then routed to the appropriate device. The footswitch and its features are described in Figure 2 below.
The Receiver The receiver connects to the devices that will be controlled by the iSwitch system. It receives commands sent from the footswitch and routes them to the appropriate device. The receiver also determines how footswitches are used and which devices they will control. The features of the receiver are listed in Figures 4 and 5. 1 2 3 4 5 6 7 Figure 4: The receiver front panel Front Panel 1. Power Switch: Powers on and off the receiver. The switch will illuminate when the unit is on. 2.
Rear Panel 1 2 3 4 5 6 7 Figure 5: The receiver rear panel 7 1. TPS output: Provides a dedicated connection to the TPS console, enabling the commands issued from the footswitch to be routed to the TPS console. 2. SERFAS output: Provides a dedicated connection to the SERFAS console, enabling the commands issued from the footswitch to be routed to the SERFAS console. 3.
Setting up the iSwitch Setting Up the Receiver 1. Position the receiver on a Stryker cart or other sturdy platform. 2. Connect the AC Power. • Connect the AC power cord to the AC input on the rear receiver panel. • Connect the other end to a hospital-grade receptacle. 3. Connect the devices that will be controlled by the footswitch System.
Setting Up the Footswitch 1. Insert the Stryker Battery Pack (P/N 277-300-100). Note It is recommended to use the Stryker Battery Pack to achieve maximum battery life and prevent improper insertion. • Twist off the cap on the side of the footswitch by turning 1/2 turn counterclockwise. • Insert the batteries. • Replace the cap and lock in place by turning 1/2 turn clockwise. 2. Synchronize the footswitch with the receiver. • Press buttons I and III simultaneously and release.
System Settings Using the 2 mode buttons on the Receiver, the system Settings may be modified as listed below: To enter the Settings mode Press and hold both mode buttons on the Receiver for 5 seconds • In this mode, the left (Footswitch 1) mode button toggles among options. • In this mode, the right (Footswitch 2) button enables or disables the settings. Settings Speed Mode (Default: Enabled) • When enabled, a single press of button II on the Footswitches changes the mode.
Operating the iSwitch System Note Using Stryker disposable bags (P/N 277-500-100) is recommended to keep the footswitch clean during use. Contact your local Stryker representative for ordering information. The iSwitch system is operated through the controls on the footswitch and the controls on the receiver. Using the Footswitch Controls 1. Press the mode button to select which device the footswitch will control. The footswitch buttons will perform according to the mode selected.
SERFAS Mode Select Device* (SERFAS, TPS, etc.) Decrease Cut Level Cut Increase Cut Level Coag Using the Receiver Controls While the footswitch controls the devices connected to the iSwitch system, the receiver controls how the footswitch functions. Receiver controls are used for selecting which device the footswitch will control, unsynchronizing footswitches, and merging footswitches. Selecting which device the footswitch will control Press the mode button to toggle through the connected devices.
Cleaning and Maintenance Cleaning WARNING Unplug the receiver from the electrical outlet before cleaning the unit. Caution Do not immerse the footswitch in any liquid, as product damage may result. Caution Do not use solvents, such as alcohol, or cleaning solutions that contain ammonia to clean the footswitch, as product damage may result. Caution Do not sterilize the footswitch or receiver, as product damage will result. 1. Wipe the footswitch with a soft cloth dampened in a mild cleaning solution.
Troubleshooting Problem Possible Solution No results when the Footswitch is pressed. • • • Press buttons I or III to wake Footswitch. Synchronize the Footswitch. Replace batteries. The Footswitch will not synchronize with the receiver. • Hold the Footswitch synchronization icon within one inch of the receiver synchronization icon. Press buttons I and III simultaneously and release. Replace batteries and try again. • • The receiver does not indicate that an attached device is attached upon startup.
Technical Specifications Environmental Specifications Operating Temperature: Humidity: 10° to 40°C 35% to 75% RH Shipping/Storage Operating Temperature: Humidity: 10° to 40°C 35% to 75% RH System Input Power Requirements Voltage: Frequency: Current: Fuse Rating: 100-240 VAC 50/60 Hz 0.6 Amps 1.
Wireless USB Specifications Frequency range: Modulation: Power: 2.402 Hz -- 2.478 GHz Direct Sequence Spread Spectrum (DSSS) 0 dBm RFID Specifications Frequency: Modulation: Power: 125 KHz Binary Pulse Length Modulation (BPLM) <0.001W FCC ID SSH-WUF IC ID 4919C-WUF Standards Compliance IEC 60601-1:1988 + A1:1991 + A2:1995 IEC 60601-1-2: 2001 IEC 60601-2-2:1998 CAN/CSA C22.2 No. 601.1-M90 UL 60601-1:2003 AS 3200.1.
Electromagnetic Compatibility Like other electrical medical equipment, the iSwitch requires special precautions to ensure electromagnetic compatibility with other electrical medical devices. To ensure electromagnetic compatibility (EMC), the iSwitch must be installed and operated according to the EMC information provided in this manual. Note The iSwitch has been designed and tested to comply with IEC 60601-1-2:2001 requirements for EMC with other devices.
Guidance and Manufacturer's Declaration: Electromagnetic Immunity iSwitch is intended for use in the electromagnetic environment specified below. The customer or the user of iSwitch should ensure that it is used in such an environment. Electromagnetic Environment: Guidance Immunity Test IEC 60601 Test Level Compliance Level Electrostatic Discharge (ESD) IEC61000-4-2 ±6kV contact ±8kV air ±2,4,6kV contact ±2,4,8kV air Floors should be wood, concrete, or ceramic tile.
Guidance and Manufacturer's Declaration: Electromagnetic Immunity iSwitch is intended for use in the electromagnetic environment specified below. The customer or the user of iSwitch should ensure that it is used in such an environment. Immunity Test IEC 60601 Test Level Compliance Level Conducted RF IEC 61000-4-6 3 Vrms 150 kHz to 80 MHz 3V Radiated RF IEC 61000-4-3 3 V/m 80MHz to 2.
Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and the iSwitch System The iSwitch system is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
Warranty This Stryker Endoscopy product is warranted to the original purchaser for a period of one year from the date of purchase to be free from defects in material and workmanship. This warranty extends to all purchases and is limited to the repair or replacement of the product without charge when returned to: Stryker Endoscopy 5900 Optical Court San Jose, CA 95138 Stryker Endoscopy cannot accept responsibility for returns or replace-ments which have not been authorized.
Other Service For service in the U.S.A., call your Stryker Endoscopy representative or call Stryker Endoscopy Customer Service at 1-800-624-4422. Outside of the U.S.A., please contact your Stryker Endoscopy distributor at one of the following locations: Stryker Corporation 2725 Fairfield Road Kalamazoo, MI 49002 USA Phone:1-269-385-2600 Telex:224464 STRYKER KMZ Fax:1-269-385-1996 Stryker European Rep - RA/QA Manager ZAC Satolas Green Pusignan Av.
Stryker Finland PL 80 (Makelankatuz) FIN 00501 Helsinki FINLAND Phone:358 (0) 9 7744 680 Fax:358 (0) 9 7744 6820 Stryker Middle East / Africa Via Della Posta 6934 Bioggio Switzerland Phone:(4021) 212-1122 Fax:(4021) 212-1133 Stryker Korea 11F Dong Sung Bldg.
