Covidien RC100 Surgassist Remote Control Unit User Manual REF RCP

Power Medical Interventions, Inc. Surgassist Remote Control Unit REF RCP

Users Manual

- DRAFT -REF RC100Wireless Remote Control Unit (RCU)Instructions For UseIntroductionThe SurgASSIST™ System Remote Control Unit is the hand held portion of the remote control sub-system. The entire wireless system consists of this hand held battery-powered unit and a radiofrequency receiver-antenna mounted within the Power Console (PC100).The wireless RCU is capable of providing remote control operation of the Power Console (PC) within a15-foot radius of the instrument.DescriptionThe SurgASSIST™ Remote Control Unit is a battery powered, hand held device that has transmitscontrol commands to the Power console. A battery capable of supplying power throughout the life of theRemote is permanently installed in the hermetically sealed case. Each Remote Control Unit ispreprogrammed with a unique identification code. When the Remote is used to power-on the PowerConsole, this identification code is read and stored by the Console. The Console with the storedidentification code will then only respond to commands sent by its corresponding Remote Control.Interference from other remotes in the area is prevented by the summation of the following:1 Each command issued from the remote control is of very short duration, the probability of any tworemotes being activated at exactly the same time is unlikely.2 The Remote Control identification number precedes every command sent. The Power Console willonly respond to commands sent from the Remote identified when the system was initially turned on.3 The receiver sensitivity is reduced to minimize long-range reception from possible interferingtransmissions. The physical closeness of its own remote with its relatively high RF output levelshould easily overpower any interfering signal.
DLU OPEN / CLOSE KEYFLEXSHAFT DIRECTIONAL RELEASEFLEXSHAFT ARTICULATIONTIP DIRECTIONAL KEY DLU FIRE KEY ON “START” KEYFigure 1: Wireless Remote Control Key Functions
Procedure1. Prior to switching “ON” the SurgASSIST System Power Console, verify that the hand-held “WiredRemote Control Unit” is not attached to the front panel PC connection. Switch “ON” the Power Consolelocated on the rear panel. PC indicator continuously flashes.2. With the hand-held Wireless Remote Control within a 15 foot perimeter of the SurgASSIST SystemPower Console, press the “ON Key of the remote. The power On indicator located on the PC displaypanel will illuminate continuously. The Wireless Remote Control Unit will now be MATED to that PowerConsole via radio frequency (RF) link. All Remote Control key commands to that Power Console willnow exist via RF link3. Utilize the Wireless Remote Control Unit identically to that of the Wired Unit. Refer to SurgASSISTOperator’s Manual, REF OPMA, for complete System operation.4. When the Power Console is Reset or Turned “OFF” via rear panel switch, the MATED RemoteControl Unit will no longer become MATED. Re-MATING will occur with the Wireless Remote ControlUnit the next time the Power Console is turned “ON” and the RCU is keyed as in step No. 2, above.WARNINGIn the extremely unlikely event that the PowerConsole power indicator lights continuouslybefore the Remote Control pushbutton ispressed, it may indicate that the consolelocked to another remote. If this should occur,simply toggle the Power Console power switchmomentarily to the “OFF” position and repeatstep No. 1.This device complies with Part 15 of the FCC rules.Operation is subject to the following two conditions: (1) Thisdevice must not cause harmful interference, and, (2) thisdevice must accept any interference received, includinginterference that may cause undesired operation.FCC ID: XXXABC123PerformanceOperating RangeThe operating range is required to be at least 15 feet.
Battery LifeA fresh battery within a Remote Control Unit has sufficient capacity to last at least 2000procedures.If the command pushbutton is continuously held down, RF transmission is terminated after 5seconds and will only resume when the next command is issued. *Battery Shelf life: > 90 % capacity remaining after 7-year storage at a temperature not to exceed37°C.Low Battery WarningA low battery warning will be displayed on the PC message panel when the remaining batterycapacity is estimated to be insufficient to complete at least 100 surgical procedures. This isintended as information to the user that the surgical procedure can continue, but the RCU shouldbe replaced prior to starting another set of procedures on the next patient. If the user elects tocontinue without replacing the Remote, the “Battery Empty” message will be displayed when thebattery counter decrements by an amount equivalent to 50 additional procedures.Battery Empty MessageThis message will be displayed when the amount of battery energy available is estimated to beless then what is required to complete at least 50 procedures. The PC will not respond to any ofthe Power Console control commands issued from this remote.Display of this message continues until the battery is depleted beyond its capacity to power theRCU transmitter.Battery TimersA series of timers protect the battery from excessive power drain. The processor will automaticallydisconnect itself and the RF module from the battery within 100 ms after the last transmission. Ahardware timer will temporarily disconnect the battery after 10 seconds if any pushbutton iscontinuously held down.Radio Frequency (RF) Characteristics (USA, Canada and Europe)Center Frequency (Carrier)418 MHzMaximum Transmission Period5 seconds (controlled by processor)Controls and Indicators
RCU ControlsThe design and placement of the control pushbuttons allow the user to comfortably operate theRemote Control Unit with one hand. A set of four pushbuttons arranged as compass points (North,South, East and West) control the steering portion of the shaft. Other pushbuttons are arranged bysize and shape to allow commands to be sent without the need to continuously view the Remote.The other functions are Steering Release, Open / Close, Fire, and On.Number of CommandsAny combination of pushbuttons may be depressed simultaneously. All combinations will betransmitted to the PC.MessagesMessages are displayed on the Power Console to provide user feedback after each pushbutton isdepressed. The messages listed are specific to operation of the Remote Control UnitMessage When DisplayedA short blink ofthe PC “Power”indicator lampshows receipt of acommand.Momentarily when any transmitted command isreceived.“Remote controlBattery lowReplace afterprocedurePress onTo continue”Displayed when the Remote is matched with thePC and the battery capacity counter is less then12. Sufficient capacity remains for less then 100surgical procedures.“Replace RemoteControl Now” Displayed when battery capacity cannot bedeemed sufficient to complete a procedure. Thebattery capacity counter is less then 6.Available Battery CapacityThe counter within the Remote Control Unit will decrement by one count for each standard periodof time of operation. The Remote Control will keep track of elapsed usage and subtract usage fromavailable battery life.Input and Output Connections Required• RCU Inputs and OutputsThe RCU is hermetically sealed and does not require any user accessible input or outputconnections. Internal connections include the transmitter antenna and battery terminals.
• Receiver AntennaThe receiver antenna is permanently mounted within the Power Console.Power Requirements• RCUThe Remote Control Unit is powered by a high temperature lithium battery that is not fieldreplaceable.• BatteryHigh temperature (150 C) lithium AA cell 3.8 VDC, 1.6 Ah• Input Voltage2.8 to 4.0 VDCEnvironmental RequirementsRCUThe RCU is intended for use in normal indoor environments. The case is hermetically sealed,capable of total submersion while cleaning or sterilization procedures are conducted.Battery Disposal: The battery is not accessible for replacement. Once a RCU battery isdetermined to be at is useful end, contact your local Environmental Agency for the proper disposalof lithium batteries. DO NOT DIS-ASSEMBLE REMOTE CONTROL UNIT TO ACCESSBATTERY. DISPOSE OF REMOTE CONTROL HANDLE IN ITS ENTIRITY.Operating Ambient Conditions• Ambient TemperatureThe ambient operating temperature range is 10°C to 40°C (50°F to 104°F)• Relative Humidity10% to 100% RHStorage and Distribution Conditions• Ambient TemperatureThe anticipated temperature extremes are -40°C to 70°C (-40°F to 150°F)
• Relative Humidity10% to 100% RHSterilization• Type of Sterilization AllowedEthylene Oxide gas, Liquid chemical systems containing peracetic acid.Steam Autoclave.Standard Recommendations for Autoclave Steam Flash SterilizationCHARACTERISTICS OFITEM GRAVITY VACUUMNonporusNon-Lumened3 minutes @ 270°F(132°C) with no weightrestrictions, load sizerestrictions or densityrestrictions. Instrumentsmust be properlydecontaminated3 minutes @ 270°F(132°C) with no weightrestrictions, load sizerestrictions or densityrestrictions. Instrumentsmust be properlydecontaminatedNumber of Sterilization Cycles AllowedThe Remote Control Unit has been qualified to function after a minimum of 200 autoclave FlashSterilization cycles, hospital ETO cycles and Steris I, peracetic acid cycles without exhibitingmaterial degradation or other functional defects.WARNINGS:DISPOSE OF REMOTE CONTROL UNIT IN THE PROPER FASHION. DO NOT EXPOSE UNITTO EXCESSIVE HEAT (>160 C) AS INTEGRAL BATTERY MAY HAVE CATASTROPHICFAILURES.CONSULT LOCAL ENVIRONMENTAL REGULATIONS FOR PROPER DISPOSAL OF LITHIUMION BATTERIES.DO NOT CRUSH, PUNCTURE, OR ATTEMPT TO DISASSEMBLE A REMOTE CONTROL UNIT.ENSURE THAT ALL HOSPITAL STEAM STERILIZATION AUTOCLAVES HAVE PROPERTEMPERATURE FAULT CIRCUITS INSTALLED.
\New Hope, PA 18938 USA215-862-4450

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