Covidien RC100 Surgassist Remote Control Unit User Manual REF RCP
Power Medical Interventions, Inc. Surgassist Remote Control Unit REF RCP
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Users Manual
- DRAFT -
REF RC100
Wireless Remote Control Unit (RCU)
Instructions For Use
Introduction
The 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 radio
frequency receiver-antenna mounted within the Power Console (PC100).
The wireless RCU is capable of providing remote control operation of the Power Console (PC) within a
15-foot radius of the instrument.
Description
The SurgASSIST™ Remote Control Unit is a battery powered, hand held device that has transmits
control commands to the Power console. A battery capable of supplying power throughout the life of the
Remote is permanently installed in the hermetically sealed case. Each Remote Control Unit is
preprogrammed with a unique identification code. When the Remote is used to power-on the Power
Console, this identification code is read and stored by the Console. The Console with the stored
identification 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 two
remotes being activated at exactly the same time is unlikely.
2 The Remote Control identification number precedes every command sent. The Power Console will
only 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 interfering
transmissions. The physical closeness of its own remote with its relatively high RF output level
should easily overpower any interfering signal.
DLU OPEN / CLOSE KEY
FLEXSHAFT DIRECTIONAL RELEASE
FLEXSHAFT ARTICULATION
TIP DIRECTIONAL KEY DLU FIRE KEY
ON “START” KEY
Figure 1: Wireless Remote Control Key Functions
Procedure
1. Prior to switching “ON” the SurgASSIST System Power Console, verify that the hand-held “Wired
Remote Control Unit” is not attached to the front panel PC connection. Switch “ON” the Power Console
located on the rear panel. PC indicator continuously flashes.
2. With the hand-held Wireless Remote Control within a 15 foot perimeter of the SurgASSIST System
Power Console, press the “ON Key of the remote. The power On indicator located on the PC display
panel will illuminate continuously. The Wireless Remote Control Unit will now be MATED to that Power
Console via radio frequency (RF) link. All Remote Control key commands to that Power Console will
now exist via RF link
3. Utilize the Wireless Remote Control Unit identically to that of the Wired Unit. Refer to SurgASSIST
Operator’s Manual, REF OPMA, for complete System operation.
4. When the Power Console is Reset or Turned “OFF” via rear panel switch, the MATED Remote
Control Unit will no longer become MATED. Re-MATING will occur with the Wireless Remote Control
Unit the next time the Power Console is turned “ON” and the RCU is keyed as in step No. 2, above.
WARNING
In the extremely unlikely event that the Power
Console power indicator lights continuously
before the Remote Control pushbutton is
pressed, it may indicate that the console
locked to another remote. If this should occur,
simply toggle the Power Console power switch
momentarily to the “OFF” position and repeat
step No. 1.
This device complies with Part 15 of the FCC rules.
Operation is subject to the following two conditions: (1) This
device must not cause harmful interference, and, (2) this
device must accept any interference received, including
interference that may cause undesired operation.
FCC ID: XXXABC123
Performance
Operating Range
The operating range is required to be at least 15 feet.
Battery Life
A fresh battery within a Remote Control Unit has sufficient capacity to last at least 2000
procedures.
If the command pushbutton is continuously held down, RF transmission is terminated after 5
seconds 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 exceed
37°C.
Low Battery Warning
A low battery warning will be displayed on the PC message panel when the remaining battery
capacity is estimated to be insufficient to complete at least 100 surgical procedures. This is
intended as information to the user that the surgical procedure can continue, but the RCU should
be replaced prior to starting another set of procedures on the next patient. If the user elects to
continue without replacing the Remote, the “Battery Empty” message will be displayed when the
battery counter decrements by an amount equivalent to 50 additional procedures.
Battery Empty Message
This message will be displayed when the amount of battery energy available is estimated to be
less then what is required to complete at least 50 procedures. The PC will not respond to any of
the Power Console control commands issued from this remote.
Display of this message continues until the battery is depleted beyond its capacity to power the
RCU transmitter.
Battery Timers
A series of timers protect the battery from excessive power drain. The processor will automatically
disconnect itself and the RF module from the battery within 100 ms after the last transmission. A
hardware timer will temporarily disconnect the battery after 10 seconds if any pushbutton is
continuously held down.
Radio Frequency (RF) Characteristics (USA, Canada and Europe)
Center Frequency (Carrier)
418 MHz
Maximum Transmission Period
5 seconds (controlled by processor)
Controls and Indicators
RCU Controls
The design and placement of the control pushbuttons allow the user to comfortably operate the
Remote 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 by
size 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 Commands
Any combination of pushbuttons may be depressed simultaneously. All combinations will be
transmitted to the PC.
Messages
Messages are displayed on the Power Console to provide user feedback after each pushbutton is
depressed. The messages listed are specific to operation of the Remote Control Unit
Message When Displayed
A short blink of
the PC “Power”
indicator lamp
shows receipt of a
command.
Momentarily when any transmitted command is
received.
“Remote control
Battery low
Replace after
procedure
Press on
To continue”
Displayed when the Remote is matched with the
PC and the battery capacity counter is less then
12. Sufficient capacity remains for less then 100
surgical procedures.
“Replace Remote
Control Now” Displayed when battery capacity cannot be
deemed sufficient to complete a procedure. The
battery capacity counter is less then 6.
Available Battery Capacity
The counter within the Remote Control Unit will decrement by one count for each standard period
of time of operation. The Remote Control will keep track of elapsed usage and subtract usage from
available battery life.
Input and Output Connections Required
• RCU Inputs and Outputs
The RCU is hermetically sealed and does not require any user accessible input or output
connections. Internal connections include the transmitter antenna and battery terminals.
• Receiver Antenna
The receiver antenna is permanently mounted within the Power Console.
Power Requirements
• RCU
The Remote Control Unit is powered by a high temperature lithium battery that is not field
replaceable.
• Battery
High temperature (150 C) lithium AA cell 3.8 VDC, 1.6 Ah
• Input Voltage
2.8 to 4.0 VDC
Environmental Requirements
RCU
The 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 is
determined to be at is useful end, contact your local Environmental Agency for the proper disposal
of lithium batteries. DO NOT DIS-ASSEMBLE REMOTE CONTROL UNIT TO ACCESS
BATTERY. DISPOSE OF REMOTE CONTROL HANDLE IN ITS ENTIRITY.
Operating Ambient Conditions
• Ambient Temperature
The ambient operating temperature range is 10°C to 40°C (50°F to 104°F)
• Relative Humidity
10% to 100% RH
Storage and Distribution Conditions
• Ambient Temperature
The anticipated temperature extremes are -40°C to 70°C (-40°F to 150°F)
• Relative Humidity
10% to 100% RH
Sterilization
• Type of Sterilization Allowed
Ethylene Oxide gas, Liquid chemical systems containing peracetic acid.
Steam Autoclave.
Standard Recommendations for Autoclave Steam Flash Sterilization
CHARACTERISTICS OF
ITEM GRAVITY VACUUM
Nonporus
Non-Lumened
3 minutes @ 270°F
(132°C) with no weight
restrictions, load size
restrictions or density
restrictions. Instruments
must be properly
decontaminated
3 minutes @ 270°F
(132°C) with no weight
restrictions, load size
restrictions or density
restrictions. Instruments
must be properly
decontaminated
Number of Sterilization Cycles Allowed
The Remote Control Unit has been qualified to function after a minimum of 200 autoclave Flash
Sterilization cycles, hospital ETO cycles and Steris I, peracetic acid cycles without exhibiting
material degradation or other functional defects.
WARNINGS:
DISPOSE OF REMOTE CONTROL UNIT IN THE PROPER FASHION. DO NOT EXPOSE UNIT
TO EXCESSIVE HEAT (>160 C) AS INTEGRAL BATTERY MAY HAVE CATASTROPHIC
FAILURES.
CONSULT LOCAL ENVIRONMENTAL REGULATIONS FOR PROPER DISPOSAL OF LITHIUM
ION BATTERIES.
DO NOT CRUSH, PUNCTURE, OR ATTEMPT TO DISASSEMBLE A REMOTE CONTROL UNIT.
ENSURE THAT ALL HOSPITAL STEAM STERILIZATION AUTOCLAVES HAVE PROPER
TEMPERATURE FAULT CIRCUITS INSTALLED.
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New Hope, PA 18938 USA
215-862-4450