Stryker Instruments 5400 TPS Core Console w/ Cutter Recognition User Manual 5400 050 700 final pmd

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Date Submitted	2004-09-24 00:00:00
Date Available	2004-09-24 00:00:00
Creation Date	2004-09-10 20:27:36
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Document Title	5400-050-700_final.pmd
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IMPORTANT INFORMATION: File in your maintenance records
Consolidated Operating Room Equipment
(CORE) Powered Instrument Driver
REF 5400-50
Instructions For Use
••••••••••••••••••••••
US Patents: ??? and other patents pending.
Software Version
4100 E. Milham
Kalamazoo, Michigan
(USA) 49001
1-269-323-7700
1-800-253-3210
5400-050-700 Rev-
RA
4.x
10/04
Table of Contents
Important Information ....................................................................................................................................................................................... 3
Compliance Statements ................................................................................................................................................................................... 3
Software License Notice .................................................................................................................................................................................. 4
Limited Warranty .............................................................................................................................................................................................. 4
User/Patient Safety .......................................................................................................................................................................................... 5
Indications For Use .......................................................................................................................................................................................... 5
Contraindications ............................................................................................................................................................................................. 5
System Overview ............................................................................................................................................................................................. 6
System Block Diagram .................................................................................................................................................................................... 6
Hardware Features .......................................................................................................................................................................................... 7
Accessories ..................................................................................................................................................................................................... 7
Operating Instructions ...................................................................................................................................................................................... 8
Interconnect Diagram .................................................................................................................................................................................. 8
To Connect the Components: ...................................................................................................................................................................... 9
Button Definitions ...................................................................................................................................................................................... 10
Software Menu Map ................................................................................................................................................................................... 12
To Power Up: ............................................................................................................................................................................................. 13
To View Options: ........................................................................................................................................................................................ 14
To Adjust Handpiece Speed (or Power): ................................................................................................................................................ 15
To Select Handpiece Direction and Mode: ............................................................................................................................................ 15
To Adjust Options: .................................................................................................................................................................................. 16
To Program Footswitch Options: ....................................................................................................................................................... 17
To Set Handpiece Options: ................................................................................................................................................................ 19
To Select a User Preference Favorite: .................................................................................................................................................. 20
To Replace a User Preference Favorite ............................................................................................................................................ 20
To Adjust Irrigation Pump Settings: ....................................................................................................................................................... 21
To Adjust the Console Settings: - Standard and Advance User Mode .................................................................................................. 21
To Manage User Preference Files: - Advance User Mode Only ....................................................................................................... 23
To Access Help: ..................................................................................................................................................................................... 27
Troubleshooting Guidelines ........................................................................................................................................................................... 28
Periodic Maintenance .................................................................................................................................................................................... 28
Storage and Handling .................................................................................................................................................................................... 28
Cleaning and Sterilization Recommendations ............................................................................................................................................... 28
Error Messages ............................................................................................................................................................................................. 29
Messages ................................................................................................................................................................................................... 30
Specifications ................................................................................................................................................................................................. 31
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© 2003, 2004 Stryker Corporation
Important Information
WARNING - CAUTION - NOTE
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 and user may be involved. Disregarding this information could result in injury to
the patient and/or user.
CAUTION:
These instructions point out special service procedures or precautions that must be followed to avoid damaging
the instrument.
NOTE:
This provides special information to make maintenance easier or important instructions clearer.
An exclamation point within a triangle displayed on the product is intended to alert the user to the presence of important
operating and maintenance instructions in this manual.
Compliance Statements
Federal Communications Commission (FCC)
FCC ID: Q9R-5400
Industry Canada (IC)
IC: 4919A-5400
This device complies with Part 15 of the FCC rules. Operation is
subject to the following two conditions: (1) this device may not
cause harmful interference, and (2) this device must accept any
interference received, including interference that may cause
undesired operation.
The term "IC:" before the radio certification number only signifies
that Industry Canada technical specifications were met.
NOTE:
FCC regulations provide that changes or modifications
not expressly approved by Stryker Instruments could void your
authority to operate this equipment.
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Software License Notice
The Stryker CORE Powered Instrument Driver (console) contains software that is installed by Stryker Corporation (“Stryker”). Stryker
owns this software and is licensing it to you, the original CORE Console customer, subject to the following terms and conditions.
Stryker hereby grants you a nonexclusive, nontransferable License to use the software to operate the CORE Console for your own use
and to perform maintenance thereon. You hereby agree that you will not copy, alter, modify, translate, disassemble, decompile, reverse
engineer, create derivative works of, distribute, sub-license, sell, lease, lend, or otherwise transfer all or any portion of this software, in
either original or modified form, except as specifically authorized under this License Agreement. In addition, you agree that you will not
use this software in any product other than the Stryker product in which the software was initially installed by Stryker.
EXCEPT FOR ANY WARRANTIES THAT MAY BE EXPRESSLY PROVIDED IN THE STRYKER PRODUCT LITERATURE
ACCOMPANYING YOUR CORE CONSOLE OR SOFTWARE, THIS SOFTWARE AND DOCUMENTATION IS PROVIDED “AS IS,”
AND STRYKER MAKES NO REPRESENTATIONS OR WARRANTIES, EXPRESS OR IMPLIED, INCLUDING BUT NOT LIMITED TO,
WARRANTIES OF MERCHANTABILITY OR FITNESS FOR ANY PARTICULAR PURPOSE.
STRYKER WILL NOT BE LIABLE FOR ANY INDIRECT, SPECIAL, PUNITIVE OR CONSEQUENTIAL DAMAGES ARISING OUT OF
ANY USE OF THE SOFTWARE OR DOCUMENTATION.
By using this software, you acknowledge and agree that you have read, understood, and agree to be bound by these terms and
conditions.
Limited Warranty
In the USA only, products of Stryker Instruments are warranted to the original purchaser for a period of one year from the date of
purchase, with exceptions noted below. Products are warranted to be free from defects in material and workmanship. Abnormal wear
and tear or damage caused by misuse or by failure to perform normal and routine maintenance as set out in the Maintenance Manual
or Operating Instructions, or as demonstrated by an authorized Stryker Instruments representative, is not covered by the warranty. Any
effort at field repair or adjustment may invalidate your warranty. Using any accessory that is not a Stryker product will invalidate your
warranty.
The warranty extends to all purchasers and is limited to the repair or replacement of the product without charge when returned prepaid
to Stryker Instruments. There are no other expressed warranties. This warranty gives you specific legal rights and you may have
other rights, which vary by state and municipality.
For selected products.
•
Universal Handswitch is warranted for a period of 6 months from date of invoice.
•
Handpiece cords are warranted for a period of 6 months from date of invoice.
•
Cutting accessories are not warranted.
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User/Patient Safety
WARNINGS:
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
Before using any system component, or any component compatible with this system, read and understand the instructions. Pay
special attention to the important User/Patient Safety information provided in the instruction booklets. Familiarization with the
system prior to use is important. Failure to comply may result in patient and/or operating room staff injury or damage to
components.
The surgeon performing any procedure is responsible to determine the appropriateness of this instrument and the specific
technique for each patient. Stryker, as a manufacturer, does not recommend surgical technique.
Clean and sterilize components before first and every use. See the CORE Cleaning, Maintenance and Sterilization
Recommendations for specific details.
DO NOT use this equipment in the presence of flammable anesthetic mixture with air or with oxygen or nitrous oxide.
Prior to each use, operate system components and inspect for damage. DO NOT use if damage is apparent.
Use only Stryker approved accessories. Other accessories may not properly interface with the console. Contact your Stryker
sales representative for a complete list of accessories. DO NOT modify any accessory. Failure to comply may result in patient
and/or operating room staff injury.
All cutting accessories are intended for single use only. Reuse significantly increases wear on the handpiece and attachment.
Failure to comply may result in patient and/or operating room staff injury.
Always use the appropriate accessory combination with a handpiece. Contact your Stryker sales representative for a complete
list of accessories. Failure to comply may result in patient and/or operating room staff injury.
DO NOT attempt to insert or remove any cutting accessory or attachment while the handpiece is operating. Failure to comply
may result in operating room staff injury.
DO NOT modify the ground connection of the console power cord. Failure to comply may result in patient and/or operating room
staff injury.
DO NOT place a handpiece on a patient. Failure to comply may result in patient injury, for example burns or damage to tissue.
DO NOT place a handpiece on or near a magnetic pad or tray. A magnetic field can simulate the output of a handswitch or
footswitch and may cause the handpiece to operate inadvertently. Failure to comply may result in patient and/or operating room
staff injury.
DO NOT perform footswitch mapping (assign a handpiece port to a footswitch port) while operating a handpiece. Failure to
comply may result in patient and/or operating room staff injury.
Operating a handpiece in the Window Jog mode may increase the temperature of the handpiece. If a handpiece overheats, the
console automatically shuts off the handpiece. (The audible alarm does not warn the user if this event occurs.) Monitor the
operating time of the handpiece to prevent overheating. Failure to comply may result in patient and/or operating room staff injury.
Use safety glasses. Failure to comply may result in operating room staff injury.
NOTE:
If the console screen is touched in two places simultaneously, unintended button activation may result.
Indications For Use
The Stryker Consolidated Operating Room Equipment (CORE) System is intended for use in the cutting, drilling, reaming,
decorticating, and smoothing of teeth, bone, bone cement, and other bone-related tissue in a variety of surgical procedures, including
but not limited to Neuro, ENT, Dental and Endoscopic. It is also usable in the placement or cutting of screws, metal, wires, pins, and
other fixation devices.
Contraindications
None.
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System Overview
The Stryker CORE Powered Instrument Driver (console) provides an integrated, centrally controlled environment that promotes safe
and economical surgical practice.
The console’s software provides control over system components including the console, the graphical user interface (GUI), the
irrigation pump, and the connected handpieces and footswitches. The software’s file management capability allows you to save and
store user preference settings and have convenient access to a favorites list of the most frequently used files to improve efficiency.
The color display, with its touch sensitive screen, provides an intuitive graphical user interface that allows you to view multiple system
components and set their parameters with the touch of a finger. Changes may be made rapidly, with little to no interruption during
surgery.
Multiple handpieces and footswitches may be connected and operated simultaneously from a single console. The console provides a
common interface for both micro and heavy-duty handpieces. Because options vary among different handpieces, the console will only
display those options that are related to the connected handpiece.
Various cutting accessories and irrigation cassettes used with the system are also recognized and identified on the console screen by
means of a wireless tag technology.
The console’s enhanced serial interface provides a serial communications channel between the console and other devices. This
feature allows the transfer of data and control information, like run-time data and software upgrades over a computer network.
An integral irrigation pump system reliably supplies coolant/irrigation to the cutting site with adjustable flow rates.
Console settings, like display brightness and speaker volume, may be easily adjusted. The on board speaker provides audible
feedback during operation and configuration.
The console accepts either 115 VAC or 230 VAC input and has the capability to power heavy-duty handpieces.
System Block Diagram
115 or 230 VAC
Facility Power
Enhanced Serial Interface
Other Devices
via Computer
Network
Handpiece 1
Main Processor
Handpiece Control
Handpiece 2
CORE Console
Handpiece 3
Footswitch 1
Footswitch and Irrigation
Pump Control
Footswitch 2
Touch
Sensitive
Screen
Finger/Stylus
Input
Color
Display
Speaker
Irrigation Pump
Graphical/
Audio Output
Irrigation Pump
Cassette
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Hardware Features
Color Touch Screen
Display Area; allows
you to view and make
handpiece settings using
its touch screen
capability
Footswitch Connection
Area; allows you to
connect two
footswitches simultaneously.
Handpiece Connection Area; allows you
to connect three
handpieces simultaneously.
Irrigation Pump
Cassette; install the
irrigation cassette here
if you use the irrigation
pump (optional).
Power Switch;
press to turn
console power
ON and OFF.
Speaker; provides
audible sounds and
alarms (located inside
console).
Irrigation Bag Pole
Mounting Bracket;
connect the pole here if
you use the irrigation
pump (optional).
Enhanced Serial Interface Connectors; three
communication ports allow you to transfer data and control
information, including software upgrades.
Power Receptacle; connect the
console to facility power using the
console power cord. The console will
accept 115 or 230 V facility power.
Accessories
WARNING:
Use only Stryker approved accessories. Other accessories may not properly interface with the CORE
Console. Contact your Stryker sales representative for a complete list of accessories. DO NOT modify any accessory.
Failure to comply may result in patient and/or operating room staff injury.
Description
REF
Power Cord ................................................................................................................................................................................. 0996-851-010
Cable; push-pull type connector with alignment markings and keyed connectors .................................................................. 5100-004-000
Footswitch .................................................................................................................................................................................. 5100-008-000
Disposable Irrigation Cassette ................................................................................................................................................... 5400-050-001
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Operating Instructions
Interconnect Diagram
The interconnect diagram provides the connection sequence of CORE system components. The diagram's numbered callouts
correspond to the numbered instructions on the next page. See the instructions for use supplied with each component for specific
connection information.
Symbol Definitions
On/Off (push-push)
Footswitch
Handpiece
Irrigation
Type BF Applied Part
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To Connect the Components:
NOTE:
Refer to the Interconnect Diagram while performing the instructions below. See the instructions for use supplied with
each component for specific connection information.
1.
2.
3.
4.
Place the console on a sturdy, flat surface near a hospital grade outlet.
Install the power cord plug into the power receptacle. Pull the bracket over the plug to secure it within the power receptacle.
Install the other end of the power cord into a hospital-grade wall outlet.
Press the power switch to turn the console on. See To Power Up and To Adjust Options sections for more information.
NOTES:
•
•
The universal power supply will automatically adjust to match the voltage and frequency of the facility power.
As you connect components to the console, the console’s screen will change to reflect the various components that are
connected.
CAUTIONS:
•
•
•
5.
6.
DO NOT thread or twist the push/pull connectors on the cords during installation or removal.
When connecting or disconnecting a cable(s) to the front of the console, always hold the cable by its connector (the plug, not the
cord). Failure to comply may result in damage to the cable or console.
Cables that are connected to the front of the console have keyed, push-pull type connectors that lock into place. DO NOT force a
connector into a console port. Each connector and port has an alignment mark to indicate proper cable orientation.
If using a footswitch, plug the footswitch cable into the console port marked with a FOOTSWITCH PORT symbol. Align the marks
and gently push the connectors together. Two footswitches may be connected to the console.
Plug the handpiece cord(s) into the console port(s) marked with a HANDPIECE PORT symbol. Align the marks and gently push
the connectors together. Three handpieces may be connected to the console and operated simultaneously.
NOTE:
7.
If using a CORE Universal Handswitch, attach it to the handpiece before you plug the cord into the handpiece.
Plug the other end of the handpiece cord(s) into the handpiece(s). See instructions for use supplied with each handpiece for
connection information.
WARNING:
8.
Use only Stryker approved cutting accessories.
Attach the cutting accessory to the handpieces. See the instructions for use supplied with each handpiece or attachment for
cutting accessory installation information.
NOTE:
If using the console irrigation pump (optional), install the Irrigation Pole REF 5100-50-28 (optional, may use equivalent
irrigation pole) to the mounting bracket on the back of the console. Hang the irrigation bag from the pole.
9. If required, install the irrigation cassette into the console port marked with a IRRIGATION PUMP CASSETTE symbol.
10. If required, connect the irrigation tubing to the irrigation bag.
11. If required, attach the irrigation clips to the handpiece(s) and connect the tubing. Connect the irrigation tubing to the handpiece.
See the instructions for use supplied with each handpiece for connection information.
12. Test all the CORE system components to ensure that they are performing properly before surgery. Refer to the Button Definitions
and Software Menu Map sections when using the graphical user interface.
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Button Definitions
Button
Button
Name
Definitions
View and adjust handpieces
and system settings
OSCILLATE
Set default mode of
handpiece to oscillate
HELP
Access task-oriented HELP
related to screen and
button functionality
FORWARD
Set default mode of
handpiece to rotate in the
forward (clockwise) direction
REVERSE
BACK
Return to the previous
screen
Set default mode of
handpiece to rotate in the
reverse (counterclockwise)
direction
LOW
Set default mode of
handpiece to operate in the
low rpm range mode
HIGH
Set default mode of
handpiece to operate in the
high rpm range mode
ADJUST
OPTIONS
Adjust handpiece, footswitch
and console options
FIXED SPEED
Set the default run mode of
the handpiece speed to
operate at the set speed only
VARIABLE
SPEED
Set the default run mode of
the handpiece speed to
respond to the degree of
pressure applied to the
handswitch or footswitch
ONE TOUCH
Set the default run mode of
the handpiece activation to
respond to one touch of a
handswitch or footswitch
PROGRAM
FOOTSWITCH
Program the footswitch
pedals and pads based on
the handpiece capabilities
ASSIGN
FOOTSWITCH
TO
HANDPIECE
Assign a specific footswitch
port to a specific handpiece
port
Name
Definitions
HOME
UP
INCREASE
DOWN
DECREASE
OK
ESC
FACTORY
DEFAULT
Scroll up
Increase the value of a
setting
Scroll down
Decrease the value of a
setting
Accept inputs, changes or
selections and return to
previous screen
Close a pop up or screen
without accepting inputs,
changes or selections and
return to previous screen
Apply original factory
default settings
10
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Button Definitions (cont'd)
Button
Name
Definitions
SET
HANDPIECE
OPTIONS
Button
Name
Definitions
Select specific handpiece
options and assign them to
a particular handpiece
button
EDIT
SETTINGS
Change user preference file
settings
MANAGE
USER
PREFERENCES
Create and modify user
preference folders and
files
SAVE
CURRENT
SETTINGS
Save current console
settings as a new user
preference file
NAVIGATE UP
ONE LEVEL
Navigate one directory
level up
ADJUST
CONSOLE
OPTIONS
Adjust console options in the
standard or advanced mode
DELETE
Delete a folder or file
ADJUST
VOLUME
AND
SCREEN
Adjust console volume,
brightness and contrast
CREATE FILE
Create a new user
preference file
ACCESS
ADVANCED
MODE
Access user preference
options
COPY
Copy a user preference
file or folder
SELECT
USER
PREFERENCE
FAVORITE
Select one of five favorite
user preference files as the
console default
CREATE
FOLDER
Create a new user
preference folder
SWAP USER
PREFERENCE
FAVORITE
Replace one of the five
favorite user preference files
with another preference file
OPEN AND
MODIFY
Open a user preference
folder and modify the
file(s) as required
ADJUST
IRRIGATION
PUMP
SETTINGS
Apply an irrigation flow rate
to a handpiece cutting
accessory
ADD
HANDPIECE
Add a handpiece to a user
preference file
FLUSH
TUBING SET
Provide a continuous
irrigation flow rate to flush
the tubing set
SAVE
CHANGES
Save changes to the
handpiece settings of a
user preference file
AUTO
PRIME
TUBING SET
Prime the tubing set from the
pump head to the irrigation
tip clip
VIEW/EDIT
SETTINGS
View and edit the user
preference file settings of
a selected handpiece
UNDO
CHANGES
Undo the last changes
made
11
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Software Menu Map
The software menu map is a visual representation of the menu structure and its hierarchy. The map also provides the sequence of
screen information provided in this manual, top down and left to right. The icons used in this map are the same icons used on buttons
in the software and are also used with the header information in this manual.
Home Screen
Adjust Speed/
Power
Adjust Options
Select
Direction/Mode
Select User
Preference
Favorite
Adjust Irrigation
Pump Settings
Swap User
Preference
Favorite
Adjust Audio
Video Controls
Program
Footswitch
Options
Adjust Console
Options
Access Help
Access
Advance User
Mode
Assign
Footswitch
Create New
Folder(s)
Manage User
Preferences
Folders
Set Handpiece
Options
Create New
File(s)
Manage User
Preference
Files
Modify File
Add Handpiece
Edit Settings
12
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To Power Up:
Power Up Screen
This screen is momentarily displayed while the console powers up. Note the software version is displayed in the lower right corner of
the screen.
Plug in Handpiece Cable Screen
If no handpieces or cords are connected to the console during initial power up, the following screen will appear:
If the Adjust Options button is
pressed before any cords or
handpieces are connected,
the following screen will
appear. At this time, console
options that are not handpiece
specific may be set up before
the sterile handpieces are
brought into the operating
room and plugged into the
console.
Adjust Options
The subdued portions of these screens
will become available once a
handpiece is plugged into the console.
These screens do not depend on
whether a footswitch is plugged into the
console.
13
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To View Options:
HOME screen
The HOME screen is where most user interaction will take place. Up to three handpieces may be displayed on the
screen simultaneously. When the console is initially turned on, the console settings are factory default settings until a
user preference file is selected or the settings are manually modified.
Handpiece Operating Area
View and modify key
handpiece settings.
View User Preference File Name
View name of file that contains
handpiece settings for a specific
procedure, for example,
ACL surgery.
Console Operating Area
Access key console
functions.
Attached Handpieces
Three handpieces may
be attached to the
console and two may
be operated simultaneously.
View Handpiece Name
View name of active
handpiece. Three
handpieces may be
connected and
displayed. Two
powered handpieces may
be operated from the same
console, simultaneously.
View Option Settings
View option settings such as irrigation,
footswitch control, and fixed or variable
RPM. All of these settings may be
modified.
View Cutting Accessory or
Attachment Name
View cutting accessory or
attachment name if the
handpiece, accessory and/or
attachment have recognition
capability.
14
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To Adjust Handpiece Speed (or Power):
From the HOME screen, touch the plus and minus buttons to adjust the handpiece speed or power set point in rpms or
percentage of power.
NOTE:
When you install a cutting accessory with cutter recognition capability, the system will automatically override
the selected speed setting in each mode to the speed settings that are appropriate for the installed cutting accessory.
While the handpiece is
running, the display
shows the actual
handpiece speed. If the
handpiece is not running,
the default or selected
speed is displayed.
The default speed is
displayed for each
handpiece until you
adjust the speed set
point based on the
handpiece capability.
Touch the adjustment buttons (or slider bar that
becomes visible when touching the speed value) to
increase or decrease the speed (power) set point.
To Select Handpiece Direction and Mode:
From the HOME screen, touch the Select Direction/Mode button to adjust the handpiece direction and mode.
FORWARD: Touch to cause
the handpiece cutting
accessory to rotate in the
forward (clockwise) direction.
REVERSE: Touch to cause the
handpiece cutting accessory to
rotate in the reverse
(counterclockwise) direction.
OSC: Touch to cause the
handpiece cutting
accessory to oscillate.
Direction Options
Select the direction of
the cutting accessory
Mode Options
Select the mode of
handpiece
operation
LOW: Touch to cause the
handpiece to operate in the
low rpm range mode.
NOTE: The available handpiece options,
including handpiece direction and mode, will
depend on the type of handpiece that is identified
at the top of the screen.
HIGH: Touch to cause the
handpiece to operate in
the high rpm range mode.
15
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To Adjust Options:
From the HOME screen, touch the Adjust Options button to adjust the handpiece and footswitch options. The available
handpiece options will depend on the type of handpiece that is identified at the top of the screen.
Select Run Mode
• FIXED: handpiece speed runs at the maximum setting
only. Varying pressure on the footswitch or handswitch
will not vary the handpiece speed.
• VARIABLE: handpiece speed responds to the degree
of pressure applied to the footswitch or handswitch.
• ONE TOUCH: Handpiece activation responds to one
touch of a trigger device
(footswitch, handswitch) and
continues to run when the
trigger device is released.
Handpiece is deactivated by
touching any trigger device.
In this mode, the handpiece
operates at constant setpoint speed/power level.
Adjust Acceleration
• Touch the plus and minus buttons or slider bar to adjust the
percent of acceleration [0 to 100%].
• At 100%, the handpiece speed accelerates quickly.
Acceleration slows as the setting approaches zero percent.
Adjust Braking
• Touch the plus
and minus buttons
or slider bar to
adjust the percent
of braking [0 to
100%].
• At 100%, the
handpiece stops
abruptly. The
amount of
deceleration
decreases as the
setting
approaches zero
percent.
Adjust Oscillate Turns
• Touch the plus and minus buttons to select the number of turns per direction when
running a handpiece in the oscillate mode.
16
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To Program Footswitch Options:
From the Adjust Options screen, touch the Program Footswitch button to program the footswitch pedals and pads based
on the capabilities of the connected handpiece. Two footswitches may be connected to and simultaneously operated
from the same console. However, two footswitches cannot be used to control the same handpiece at the same time.
View Handpiece Port
Indicates the handpiece port that the
footswitch is programmed for.
Touch the arrow buttons to scroll
through the footswitch options.
The available options are
handpiece specific. Touch the OK
button to select the option.
Assign Specific Option
Select a footswitch pedal or pad [A, B, I, II
or III] button and assign a specific option.
• LOW: pressure on the footswitch pad will cause the handpiece
to operate in the low speed range or mode.
• SPEED INCREMENT: pressure on the footswitch pad will
increment the set point speed.
• SPEED DECREMENT: pressure on the footswitch pad will
decrement the set point speed.
• IRRIGATION INCREMENT: pressure on the footswitch will
increment the pump flow set point and increase irrigation to the
handpiece cutting accessory.
• IRRIGATION DECREMENT: pressure on the footswitch will
decrement the pump flow set point and decrease irrigation to
the handpiece cutting accessory.
• IRRIGATION ON/OFF: pressure on the footswitch will toggle
the irrigation pump on and off. If pressed and held, the
irrigation pump can be turned on without running the
handpiece. Once started, the irrigation pump can be stopped
by pressing the pad again or by starting the handpiece.
• PUMP FLUSH: pressure on the footswitch will turn the
irrigation pump on at the flush rate. Once started the irrigation
pump may be stopped by pressing the pad again or by starting
the handpiece.
• CHANGE PORT: pressure on the footswitch pad will change
the footswitch assignment to another active handpiece.
• ONE TOUCH: acting like an on/off toggle, tap the footswitch
pad to operate the handpiece at the maximum speed. Tap the
footswitch pad again to stop the operation.
• VARIABLE: varying pressure on the footswitch pad will cause
the handpiece speed to vary.
• FIXED: pressure on the footswitch pad will cause the
handpiece to operate at a constant speed as set on the HOME
screen.
Based on handpiece capabilities, options may include:
• FORWARD: pressure on the pad or pedal will cause the
handpiece to rotate in the forward (clockwise) direction.
• REVERSE: pressure on the pad or pedal will cause the
handpiece to rotate in the reverse (counterclockwise) direction.
• +OSC TURNS: pressure on the footswitch pad will cause the
handpiece to oscillate; increase number of turns.
• -OSC TURNS: pressure on the footswitch pad will cause the
handpiece to oscillate; decrease number of turns.
• ON: pressure on the footswitch pad or pedal will make the port
active, for example it will provide input to the assigned
handpiece.
• OFF: pressure on the footswitch pad or pedal will make the
port inactive, for example it will not provide input to the
assigned handpiece.
• HIGH: pressure on the footswitch pad will cause the handpiece
to operate in the high-speed range or mode.
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To Program Footswitch Options:
WARNING: DO NOT perform footswitch mapping (assign a handpiece port to a footswitch port) while
operating a handpiece. Failure to comply may result in patient and/or operating room staff injury.
Assign Handpiece Port to a Footswitch Port
The Assign Handpiece to Footswitch screen will appear automatically when connecting two footswitches and two or
more handpieces to the console.
Access the Assign Handpiece to Footswitch screen manually as follows:
1. From HOME screen, press Adjust Options button
2. From Adjust Options screen, press Program Footswitch button
3. From Program Footswitch screen, press Assign Handpiece to Footswitch button
The color options above indicate the default setting for two connected footswitches and three connected handpieces.
Touch the handpiece name button to toggle through the four color options. Each color indicates a footswitch to
handpiece port assignment as described below:
Green indicates the top (green) footswitch port is assigned to the handpiece port.
Yellow indicates the bottom (yellow) footswitch port is assigned to the handpiece port.
Green/Yellow combination indicates both footswitch ports are assigned to the handpiece port.
Gray indicates no footswitch port is assigned to the handpiece port.
Color icon indicates which handpiece will be operated when the associated footswitch is
actuated.
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To Set Handpiece Options:
WARNING:
Read and understand the appropriate Stryker handpiece instructions for use.
From the Adjust Options screen, touch the Set Handpiece Options button to select specific handpiece options and
assign them to a particular handpiece button. Options are handpiece dependent and may not be available if the
handpiece does not support them. Handpiece attachments may also be selected, if supported. If selected, the console
will display the correct attachment information and set maximum speed values for the handpiece.
Select Handpiece
Attachment
Select specific
attachment based
on the handpiece
capability.
Touch arrows to
scroll through and
highlight a
handpiece
attachment.
Program Handpiece Buttons
• Touch numbered button to assign
an option.
• Select specific options and assign
them to a particular handpiece
button based on handpiece
capability.
Based on handpiece capabilities, options may include:
• FORWARD: option will rotate cutting accessory in the forward (clockwise) direction.
• REVERSE: option will rotate cutting accessory in the reverse (counterclockwise) direction.
• +OSC TURNS: option will increase the number of oscillate turns.
• -OSC TURNS: option will decrease the number of oscillate turns.
• HIGH: option will operate handpiece in the high-speed mode.
• LOW: option will operate handpiece in the low speed mode.
• CHANGE PORT: option will change the button assignment to another active handpiece.
• +IRRIGATION: option will increase irrigation to the handpiece cutting accessory.
• -IRRIGATION: option will decrease irrigation to the handpiece cutting accessory.
• WINDOW JOG TRIGGER: option will rotate the cutting accessory at a very low speed to position the cutting edge
within the cutting window.
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To Select a User Preference Favorite:
From the HOME screen, touch the Select a User Preference Favorite button to select a favorite user preference file or
replace an existing one. Five favorite files are available. Each file contains specific handpiece(s) settings for a
particular procedure.
Touch to select one of
the five favorite user
preference files.
To Replace a User Preference Favorite
From the Select a User Preference Favorite pop up, make a file selection via the arrow buttons and OK button, then
touch the Swap button to replace an existing favorite file.
Touch arrow buttons to scroll
through the list and highlight
one of the preference files.
Touch OK button to replace
one of the favorite preference
files.
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To Adjust Irrigation Pump Settings:
NOTE:
If using the irrigation pump, assemble the irrigation pole to the mounting bracket located on the back of the
console. Hang the irrigation bag from the pole. Install the irrigation cassette into the console pump. Attach the
irrigation clips onto the handpiece and connect the tubing.
From the HOME screen, touch the Adjust Irrigation Pump Settings button to apply an irrigation flow rate to a handpiece
cutting accessory. AUTO PRIME and FLUSH options are also provided.
Adjust Irrigation
% Setting
• Touch the slide
bar or plus,
minus buttons to
adjust the flow
rate percentage
of irrigation [1 to
100% or OFF] to
the cutting
accessory of the
handpiece.
• At 100%,
irrigation to the
handpiece is set
to maximum
flow rate. The rate
decreases as the
setting approaches
zero.
AUTO PRIME
Tubing Set
• Touch to activate
the priming
sequence of the
installed irrigation
cassette.
• The tubing will be
primed from the
pump head to the
irrigation tip clip
within 20 seconds.
• The button will
remain depressed
during the timed
operation.
Select Handpiece
• Touch one or all of the handpiece buttons to allow activation of the irrigation
pump. If no buttons are selected, the pump will not operate.
• Activation will apply an irrigation flow rate to the handpiece cutting accessory.
• The flow rate will depend on the type of handpiece.
• Activating a handpiece will gain control of the console irrigation. While the first
activated handpiece is running, activating a second or third handpiece will not
change pump flow, but may reduce irrigation to the first handpiece if a Y-splitter
is used. To gain control of console irrigation using a second or third handpiece,
activate the second or third handpiece while the first handpiece is not running.
FLUSH Tubing Set - Touch and
hold to provide a continuous flow
rate of 300 ml/min with no irrigation
clip and a minimum pressure of 30
psi when the tubing is blocked.
To Adjust the Console Settings: - Standard and Advance User Mode
From the Adjust Options screen, touch the Adjust Console Options button to adjust the volume, brightness and contrast.
Adjust Audio/Video Controls - Standard Mode
Adjust Volume
Adjust the percent of
console volume [0 to 100%]
by touching the slide bar or
the plus, minus buttons
Adjust Brightness
Adjust the percent of
console display brightness
[0 to 100%] using the slide
bar or the plus, minus
buttons
Adjust Contrast
Adjust the percent of
console display contrast [0
to 100%] using the slide bar
or the plus, minus buttons
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To Adjust the Console Settings: - Standard and Advance User Mode
Access Advance User Mode
From the Adjust Console Options screen, touch the ADV button to gain access to the Advance User
Mode and the User Preference file management system. A pop up will appear to confirm your request.
Once confirmed, the Manage User Preference button will appear.
Return to Standard User Mode
After managing user
preference files in the advance
user mode, touch the ADV
button to return to the standard
user mode.
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To Manage User Preference Folders: - Advance User Mode Only
NOTE:
You must be in the Advance User Mode to manage user preferences. See To Adjust Console Options
section for details.
From the Adjust Console Options screen, touch the Manage User Preferences button to create and modify user
preference folders and files. Each folder may contain multiple files and each file may contain the settings for multiple
handpieces used for a specific procedure and/or physician.
View Address Bar
View the directory file path (folder/file
name) to help with navigation.
Open Folder
Touch arrow buttons to scroll through and highlight a folder.
Touch folder button to access files within a folder.
Manage user preferences
MAIN
ENT
DR. CARRY
GEN
LAPARASCOPY
ORAL
Create New Folder
Touch to create a new
folder.
ESC
To Manage User Preference Files: - Advance User Mode Only
Open File
Touch arrow buttons to scroll through and highlight a file.
Touch Modify button to open and modify a file.
Create New File
Touch to create a new
file.
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To Manage User Preference Folders and Files: - Advance User Mode Only
Create a New Folder or File
From the Manage User Preferences screen (folder or file screen), touch the Create New Folder or File button to create
a new preference folder or file using a keyboard screen.
Enter a Folder or File
Name
Touch key buttons to
enter a folder or file
name.
Shift Lock/Unlock
Touch to enter symbols or numbers.
Use Backspace
Touch to delete
keystrokes.
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To Manage User Preference Folders and Files: - Advance User Mode Only
Modify File
View and Edit Settings
Touch the ADD Handpiece button to add a handpiece to the file. Once handpieces are
added to a file, touch the arrow buttons to scroll through and highlight a handpiece.
Touch the magnifying glass button to create or edit handpiece settings.
Add Handpiece
Touch to add a
handpiece to the
preference file.
Add a Handpiece
From the Modify File screen, touch the Add Handpiece button to add a handpiece to the preference file from a list of
available handpieces.
View and Add a Handpiece
Touch arrow buttons to scroll through and highlight a handpiece. Touch the
ADD button to add a handpiece to the user preference file.
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To Manage User Preference Folders and Files: - Advance User Mode Only
View and Edit Settings
From the Modify File screen, touch the View and Edit (magnifying glass) button to view and edit the preference settings
of a selected handpiece within a user preference file.
View and Edit Settings
Touch arrow buttons to scroll
through and highlight a handpiece
setting. Touch EDIT button to
change the setting.
Edit Settings
From the Edit screen, touch the EDIT button to modify the setting within the user preference file only (console defaults
remain unchanged). Notice that the user preference Edit screen below (typical example) has a light blue background
color to differentiate it from a console default Edit screen (dark blue).
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To Access Help:
From most screens or pop ups, touch the Help button to obtain specific screen and button information. Each Help
screen is divided into two columns. The right column contains a summary of the screen's overall function. The left
column provides a list of all the screen buttons and their function.
Select Help Topic Screen
View Help Topics - Touch the arrow buttons to scroll
through and view help topic information.
27
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Troubleshooting Guidelines*
Problem
Action
Sporadic electrical interference is
experienced.
Turn off all electrical equipment not in
use in the operating room. Relocate
electrical equipment; increase spatial
distance. Plug the console and other
operating room equipment into
different outlets.
*The CORE Console is not field repairable. In case of operating difficulties, return this product to Stryker Instruments for repair. For
more information, contact your Stryker sales representative or Customer Service at 1-800-253-3210.
Periodic Maintenance
Interval
Activity
Prior to Use.
Inspect console for damage or signs of wear. DO NOT use if damage is apparent.
Storage and Handling
To ensure the longevity, performance, and safety of this equipment, package in original package materials when storing
or transporting.
Cleaning and Sterilization Recommendations
WARNINGS:
•
•
Clean and sterilize handpieces before first and every use.
Cutting accessories are single use only. Sterile only if package is unopened and undamaged. DO NOT resterilize or reuse.
CORE Console, Power Cord, Cable(s) and Footswitch Cleaning Instructions
CAUTIONS:
•
•
•
DO NOT sterilize the CORE Console or power cord.
DO NOT allow moisture in any CORE Console opening, or power cord, handpiece cable and footswitch electrical connection.
DO NOT use an aerosol spray directly on the CORE Console display.
1.
Lightly wipe the CORE Console, cord, handpiece cable and footswitch surfaces with a soft cloth dampened with a non-abrasive,
hospital disinfectant or mild detergent and water.
Apply glass cleaner to a soft cloth and wipe the CORE Console display.
2.
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Error Messages*
Message
Action to Take
Error xxx. Console hardware fault is
detected.
Contact your Stryker service representative. Turn the console off and on
again. If the problem persists, return the console to Stryker for repair.
Error xxx. Footswitch fault is detected;
the right pedal is disabled.
Contact your Stryker service representative. Unplug the footswitch from the
console and plug it into the console again. If the problem persists, return the
footswitch to Stryker for repair.
Error xxx. Footswitch fault detected, left
pedal is disabled.
Contact your Stryker service representative. Unplug the footswitch from the
console and plug it into the console again. If the problem persists, return the
footswitch to Stryker for repair.
Error xxx. Footswitch is not detected or
fails to be recognized by the console.
Contact your Stryker service representative. Unplug the footswitch from the
console and plug it into the console again. If the problem persists, return the
footswitch to Stryker for repair.
Error xxx. Handpiece fault is detected,
handpiece trigger is disabled.
Contact your Stryker service representative. Unplug the cord from
handpiece and plug the cord into the handpiece again. If the problem
persists, return the handpiece to Stryker for repair.
Error xxx. Handpiece is not detected or
fails to be recognized by the console.
Contact your Stryker service representative. Unplug handpiece from
console and plug in again. If problem persists, return handpiece Stryker for
repair.
Error xxx. Handpiece requires
additional console hardware.
Contact your Stryker service representative.
Error xxx. Cutting accessory requires
additional console hardware.
See the instructions for use supplied with the cutting accessory.
* For more information, contact your Stryker sales representative or Customer Service at 1-800-253-3210.
To Be Determined
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Messages*
Message
If You Select OK to a Question
Delete all the surgeon’s user preferences?
The surgeon ID and all user preferences will be deleted.
Change the name of all the surgeon’s user preferences?
User preferences listed under the surgeon will be moved
under the current surgeon’s name.
Identical record found.
Maximum number of records exceeded. Please delete
inactive records.
To Be Determined
Initializing console hardware. Please wait.
Handpiece has reached recommended service interval.
Please return for service at earliest convenience.
Handpiece does not support the selected preference.
Default handpiece setting will be used.
Handpiece temperature has exceeded its nominal
operating range and may cause burning.
Handpiece temperature has exceeded its operating range.
Allow to cool before restarting.
Procedure name unspecified.
DO NOT allow the handpiece speed to exceed specified
attachment limitations. Failure to comply may result in
user and/or patient injury.
Cutter/bur is not compatible with the current handpiece.
Cutter/bur has exceeded its life. Please replace with a
new cutter/bur.
30
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Specifications*
Model:
REF 5400-50 CORE Console
Size:
12.5 in. [317.5 mm] width
5 in. [127 mm] height
17 in. [431.8 mm] depth
Weight:
<20 lbs. [ 9.1 kg]
Equipment Type:
Class I, Type BF Applied Part
Power Supply:
Input voltage: 120V, 60Hz, 6.0A
Output voltage: 40V + 0.25 V
Output power: 200 W continuous, 400 W peak
Enclosure Protection:
IPXO Ordinary Equipment
Protective Earth Ground:
Duty Cycle:
Peak power - 10 A, 400 W 50% duty cycle for 10 seconds
Sustained power - 5 A, 100% duty cycle for three minutes continuous
Display/Color Touch Screen:
Wide 65° minimum viewing angle;
6.5 inch diagonal active LCD;
resolution 800 (horizontal) x 480 (vertical);
16:9 aspect ratio;
16-bit color;
dimensions 3.19 in. [81.0 mm] height
5.67 in. [144.0 mm] width
Volume Adjustment:
0 dBA to 81 dBA
Environmental Conditions:
Operation
Storage and Transportation
Temperature:
Relative Humidity:
Atmospheric Pressure:
*Specifications listed are approximate and may vary slightly from unit to unit or by power supply fluctuations.
31
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4100 E. Milham
Kalamazoo, Michigan
(USA) 49001
1-269-323-7700
1-800-253-3210
RA

---

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