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Associat Opr Manual
Associat Opr Manual
30308000-H
D.O.R.C. ASSOCIATE-2500® Instruction Manual
Contents
Section 1 – Introduction ......................................................................................................................5
Section 2 – Controls and Features .....................................................................................................7
2.1 Overall Views of the unit ........................................................................................................7
2.2 Footswitch..............................................................................................................................8
2.3 Remote Control....................................................................................................................10
2.4 User or Operator Instructions for cleaning the ASSOCIATE®...............................................10
Section 3 – General Instructions ......................................................................................................11
3.1 Preparing the Unit for Use....................................................................................................11
3.2 Pre-Operating Procedure .....................................................................................................11
3.3 Installation Irrigation/Aspiration Cartridge (6279-ASC).........................................................11
3.4 Select SURGEON MEMORIES ...........................................................................................12
3.4.1 Surgeon Name ............................................................................................................12
3.4.2 Surgeon Settings.........................................................................................................12
3.5 Priming.................................................................................................................................13
3.6 Change of Pump System .....................................................................................................14
3.7 Cleaning...............................................................................................................................14
3.8 System Settings ...................................................................................................................15
3.8.1 (Main) Pedal ................................................................................................................15
3.8.2 Sound..........................................................................................................................15
3.8.3 Time ............................................................................................................................16
3.8.4 Modules.......................................................................................................................16
3.8.5 Service ........................................................................................................................16
3.8.6 Language ....................................................................................................................17
3.9 Programming .......................................................................................................................17
3.9.1 Quick Programming.....................................................................................................17
3.9.2 Program a new User ...................................................................................................18
3.9.3 Programming using default settings ............................................................................18
3.9.4 Adjusting Existing Procedures .....................................................................................20
3.9.5 Copy Existing Procedure .............................................................................................20
3.9.6 Rename User ..............................................................................................................20
3.9.7 Rename Procedure .....................................................................................................21
3.9.8 Remove User ..............................................................................................................21
3.9.9 Remove Procedure .....................................................................................................21
3.9.10 Advanced Programming ..............................................................................................22
3.9.10.1 Footswitch functions......................................................................................22
3.9.10.2 Options..........................................................................................................25
3.9.10.3 Footswitch User Settings...............................................................................26
3.9.10.4 Step Manager ...............................................................................................27
Section 4 – Phaco Module.................................................................................................................29
4.1 Quick-Start Instruction .........................................................................................................29
4.2 Description...........................................................................................................................29
4.3 Controls and Indicators ........................................................................................................31
4.4 Control interactions with other modules ...............................................................................32
4.5 Operating Procedure (Classic Phaco ).................................................................................32
4.6 Phaco Settings.....................................................................................................................34
4.7 Cleaning an occluded phaco handpiece ..............................................................................35
Section 5 – Vitrectomy Module .........................................................................................................36
5.1 Quick-Start Instructions........................................................................................................36
5.2 Description...........................................................................................................................36
5.2.1 Linear Control.............................................................................................................37
5.2.2 Dual Control ................................................................................................................38
5.3 Controls and Indicators ........................................................................................................38
5.4 Control Interactions with other modules ...............................................................................39
5.5 Operating Procedure – Posterior Vitrectomy........................................................................40
Section 6 – Scissors Module.............................................................................................................41
6.1 Scissors Mode .....................................................................................................................41
6.2 Proportional Scissors Mode .................................................................................................42
6.3 Control interactions with other modules ...............................................................................42
Section 1 – Introduction
The ASSOCIATE® is intended for ophthalmic anterior and posterior segment surgery.
The ASSOCIATE® provides all necessary functions to perform phaco and vitrectomy
surgery. The unit includes nine separate function modules, a remote control and a
footswitch.
The first part of this manual includes some general instructions for the unit. This is
followed by specific descriptions of each of the modules, in the order listed above.
The end of the manual includes a list of the accessories which may be used with the
unit.
2 3 4 5 6 7 8 9
1) Inlet pressure connector
2) Brightness control Users Interface
3) VFI+ (to set-up VFI syringe)
4) Infusion pole connector
5) Footswitch connector
6) Auxiliary connector
1 7) Earth potential point
8) ON/OFF switch
2 3 4 5 6 7 8
2.2 Footswitch
The unit includes a Multi Function Footswitch which allows the surgeon to control
many different functions on the ASSOCIATE®. For more detailed explanations, see
the instructions for the specific modules.
Push
Buttons
Switches
Figure 6. Footswitch
Press Memory
Warning !!
Before switching ON the ASSOCIATE® always connect the Footswitch
first!
Warning !!
Please check all modifications to the programming of the Footswitch
prior to actual surgery! For more information please see chapter
3.9.10.3.
Select the requested function mode with the cursor and by depressing
the “O.K.” button, selected function will be activated or preset
UP/DOWN will be activated.
Before cleaning the ASSOCIATE®, disconnect the power cord and let the
ASSOCIATE® cool down first. The ASSOCIATE® should only be cleaned with a
humid (clean or sterile water) towel. Be aware of liquid running into the
ASSOCIATE®.
1. Be sure that the unit is set to use the voltage provided by your power
outlet. The correct voltage is listed on the label on the rear of the unit.
2. Place the unit on a firm, smooth surface. Allow at least 8 inches (20 cm) of
clearance on all sides of the unit.
1. Turn ON the power to the unit using the ON/OFF switch on the rear panel.
2. Check to see that the source of compressed air is connected to the inlet
port on the rear panel of the ASSOCIATE®. The regulator for the
compressed air source should be set between 5 to 6 BAR (75-90 psi).
1. Switch ON the ASSOCIATE® and the welcome screen appears. Touch the screen
and accordingly the Main Menu will appear.
2. Press the circle indicating ”Surgeon Name”
3. In the “Select User” screen select the Surgeon program. In case the surgeon does
not have an own program, press cancel. Create a program by following the steps
in programming section (see chapter 3.9).
4. The last used procedure will come up in the “Surgeon Settings” field.
3.5 Priming
Step 1 :
• Select Surgeon’s Name
And / or :
• Select Surgeon’s Settings
• Press the blinking Priming Button
Step 2 :
• The priming screen is now automatically
displayed on screen.
• Depress the start button and wait until priming cycle is finished.
o Priming cycle can be stopped temporarily by depressing button “Pause”.
o Priming cycle can be terminated by depressing button “Stop”.
NOTE : During the priming cycle, all sub-functions can be used. E.g. the
diathermy function.
Warning :
If the cartridge is not installed correctly, the unit may not function
properly.
• It is allowed to change the pump system during the surgical procedures. A new
priming routine will not be necessary.
• In case of change from Venturi pump to peristaltic pump, the peristaltic pump will
turn as it connects to the cartridge, which results in some decrease of the
vacuum.
3.7 Cleaning
• Connect male (blue) / female (red) connectors from the Irrigation/Aspiration tubing
to each other and remove giving set from the infusion bottle.
• Depress “Start” button to activate the cleaning cycle.
• The “Start” button automatically changes into “Pause”.
o Depressing the “Pause” button, the cleaning cycle stops and “Pause button
automatically changes back into “Start” button.
• In case the “Stop” key is pressed during cleaning, the “Clean” function is aborted.
• In case fluid is not fully transferred into the cartridge, press “Clean” function for a
second time.
• (Main) Pedal
• Sound
• Time
• Function (modules)
• Service
• Language
3.8.2 Sound
In the sound system setting mode, the loudness of the following functions can be
programmed :
• Alarm
• Voice
• Others
3.8.3 Time
3.8.4 Modules
In this System Mode three optional functions can be enabled: proportional scissors,
automatic infusion pole and the choice of electric or pneumatic vitrectomes.
3.8.5 Service
3.8.6 Language
In the Language Mode, the following text (written & spoken) can be selected :
3.9 Programming
The surgeon’s personal experience can be added to create the perfect surgical
procedure.
2) Press “MEMORY”
Select a default.
7) Press the save memory button
8) Type a name for the Procedure
Warning :
Please check all modifications to the programming prior to actual
surgery!
1) Switch ON the ASSOCIATE® and the welcome screen appears. Touch the
screen. The Main Menu appears.
2) Press “Memory”
3) Select the Surgeon’s program in the “Select User” screen.
4) Select the procedure to be changed in the “Select Memory” screen.
5) The programming screen appears.
6) Adjust the values in the programming screen.
• Use the step selector to go through the several step screens.
7) Add or remove the sub functions in the option screen.
NOTE : the option screen is valid per procedure not per step !
8) Change the functions in the footswitch screen.
NOTE : the footswitch screen settings are valid per step. If a button function has
changed, it will only be changed in the step active on the screen. Not in other
steps!
It allows different functions on the footswitch during the procedure.
9) Press the SAVE M+ button.
Figure 24. Copy Existing Procedure NOTE : it is not possible to copy a user.
INFUSION UP
• The Infusion up function moves the Electric Infusion Pole UP.
INFUSION DOWN
• The Infusion down function moves the Electric Infusion Pole DOWN.
PRESET UP
• The Preset UP function increases the value of the phaco and vitrectomy functions
in active mode (not the aspiration functions).
o E.g. phaco mode, the phaco power will be increased.
o E.g. vitrectomy mode, the cutting frequency will be increased.
• A short press at the button/switch will activate the function. To increase more,
release button and press again.
PRESET DOWN
• The Preset DOWN function is the opposite of the Preset Up Function. It reduces
the values.
• A short press at the button/switch will activate the function. To decrease more,
release button and press again.
ASPIRATION UP
• The Aspiration UP increases the vacuum of the peristaltic or venturi pump.
• A short press at the button/switch will activate the function. To increase more,
release button and press again.
ASPIRATION DOWN
• The Aspiration DOWN decreases the vacuum of the peristaltic or venturi pump.
• A short press at the button/switch will activate the function. To decrease more,
release button and press again.
FLOW UP
• The Flow UP function increases the flow (cc/min) in the peristaltic pump.
• A short press at the button/switch will activate the function. To increase more,
release button and press again.
FLOW DOWN
• The Flow DOWN function decreases the flow (cc/min) in the peristaltic pump.
• A short press at the button/switch will activate the function. To decrease more,
release button and press again.
AIR UP
• The Air UP function increases the air pressure (mmHg) for the air exchange and
the GPC function.
• A short press at the button/switch will activate the function. To increase more,
release button and press again.
AIR DOWN
• The Air DOWN function decreases the air pressure (mmHg) for the air exchange
and the GPC function.
• A short press at the button/switch will activate the function. To decrease more,
release button and press again.
CONSTANT IRRIGATION
• The Constant Irrigation function activates the irrigation bottle and leaves it open
until pressed again. Also possible through panel control.
• A short press on the button/switch will activate the function. To stop the function,
release button and press again.
DIATHERMY
• The Diathermy function can be activated in the fixed mode. Depress the
button/switch. The function remains active as long as the switch/button is
depressed
• To stop the function, release the button/switch.
AIR ON/OFF
• The Air On/Off function activates and deactivates the air flow on the system. Also
possible through panel control.
• A short press on the button/switch will activate the function. To stop the function,
release button and press again.
STEP UP
• The Step UP function.
• A short press at the button/switch will bring the system to the next step. To repeat
this function, press the button/switch again.
STEP DOWN
• The Step DOWN function.
• A short press at the button/switch will bring the system to a previous step. To
repeat this function, press the button/switch again.
TAMPONADE
• The Tamponade function creates a temporary pressure increase by using the
GPC system. A timer will start with a countdown. If the countdown is finished the
tamponade function will automatically switch OFF. Depress the button/switch to
activate the tamponade.
o To stop the tamponade before the countdown is finished, press the
button/switch again.
o To repeat the tamponade, press the button/switch after the countdown is
finished.
STANDARD / REVERSED
• The Standard / Reversed mode
• Depressing the button/switch the mode switches from Standard to Reversed or
from Reversed to Standard. Depressing the button/switch again, the system will
switch back to the original status.
• The Standard/Reversed mode is only active in the Vitrectomy mode.
CUTTING ON/OFF
• The Cutting ON/OFF switches the vitrectomy on or off
• In this way the aspiration is independently controlled from the main function,
Vitrectomy.
3.9.10.2 Options
The option screen makes it possible to set the
ASSOCIATE® to a dedicated function.
E.g. pure phaco or pure vitrectomy. It makes the
screen easier to use.
SCISSORS :
• Activates or hides the scissors mode.
EXT.ASP MODE :
• Activates or hides the linear flow in peristaltic mode and the fixed aspiration in venturi
mode.
I/A :
• Activates or hides the IA mode.
LIGHT :
• Activates or hides the Light mode.
AIR :
• Activates or hides the Air mode.
VFE :
• Activates or hides the Viscous Fluid Extraction mode.
VFI :
• Activates or hides the Viscous Fluid Injection mode
TAMPONADE :
• Activates or hides the Tamponade mode.
• The air mode must be selected as well.
DELTA AIR + INF :
• Activates or hides the Air and or the Infusion pole Follow function.
• The air mode and the infusion pole mode must be selected as well.
INFUSION POLE :
• Activates or hides the Electric Infusion Pole
In the programming screen is the button for selecting the Footswitch User Settings.
The main pedal of the footswitch can be programmed in the following settings :
• Resistance:
Adjust the threshold
resistance from 0 till 10, by
depressing the UP/DOWN
buttons.
• Force (=spring force of
pedal / footswitch)
Adjust the force from 0 till 10
by depressing the UP/DOWN
buttons.
Figure 32. Programming main pedal of the footswitch
NOTE 1 : The memorized main pedal settings are valid for this procedure only but
for all steps.
NOTE 2 : Factory default settings: by depressing the Factory Preset Button, the
main pedal is programmed according to above pictures.
NOTE 1 : The memorized Dual settings are valid for this procedure only but for all
steps.
NOTE 2 : Factory default settings: by depressing the Factory Preset Button, the
main pedal is programmed according to above pictures.
Each of these steps have their own characteristics. It is convenient to have these
characteristics ready on demand.
• The ASSOCIATE® has the possibility to have an 10 steps routine program.
• The 10 steps allow combination operations with phaco and vitrectomy in 1 routine
procedure.
• In the default programs, the steps are already inside. Go to Chapter 3.8.3
4.2 Description
The module can provide linear control of aspiration in combination with both linear,
fixed and/or pulsed outputs to a phaco handpiece.
• This module features continuous auto-tuning. This allows the instrument to
maintain constant performance and adjust automatically for changes in loading.
• When the Phaco is activated, the Irrigation/Aspiration Module is also activated.
• The Peristaltic pump can produce a maximum vacuum of 500 mmHg and max.
50cc/min flow independently from each other.
• The Venturi pump can produce a maximum vacuum of 500 mmHg.
• The upper limit can be selected using the preset control buttons.
• The actual vacuum level can be controlled up to the maximum, using the
Footswitch.
Phaco :
Continuous Phaco
(40 kHz)
Pulsed Phaco
(1-125 Pulses & 10-50% Duty Cycle)
Multi Burst
(1-100 Pulses)
Cool Phaco
SoftSonic Phaco
(10-50% Duty Cycle)
• The control on the footswitch can be to the left or right, or on the buttons which
allow Dual Footswitch control.
• Dual Footswitch control allows 2 feet on 1 pedal.
• Set the max. output power %, using the UP and DOWN buttons.
Phaco Timer :
• The Phaco Timer indicates the phaco time in real time and effective time.
• The timer will be automatically reset to zero after each surgery.
• When the Phaco Module is active, the 4 other main functions I/A, Vitrectomy,
Scissors and VFE are available as well. See the separate module chapters for
more information.
• When in the Sub-Functions like the Diathermy or the VFI, the linear Mode is
activated, the Phaco, Vitrectomy, Irrigation / Aspiration, Scissors and VFE
Modules are turned OFF.
o The Main Pedal is now used for the sub-Functions.
• The reverse is also true. When the main functions are activated, the Diathermy
and the VFI Linear Modules are turned back to Fixed (button/switch control).
1. Assemble the phaco handpiece. Screw the needle onto the phaco handpiece, and
tighten it using a phaco needle wrench. It is very important that the needle
assembly is tight. If the assembly is attached loosely, the ASSOCIATE® unit will
not be able to provide the correct level of power to the needle.
2. Place the infusion sleeve over the needle. This part screws on also.
3. Install I/A cartridge to the side panel of the ASSOCIATE®.
• Connect the infusion bottle to the irrigation line.
• Connect the phaco handpiece to the infusion line of the I/A tubing set (blue
connector) and to the aspiration tubing of the I/A tubing set (red connector).
4. Check to see if the venting valve of the drop chamber is open so that the infusion
bottle is vented ! Check the height of the infusion bottle. It is advisable to set the
height between the drip chamber and the patient eye level around 65 to 80 cm. If
the optional electric infusion pole is installed, this height can be adjusted from the
screen and/or by the Footswitch.
5. If the Global Intra-ocular Air Pressure System is to be used, connect the air tubing
to the irrigation bottle. Place the drip chamber 20 cm above the patient eye to
secure a positive eye pressure. Set the ASSOCIATE® Air pressure to 55-70
mmHg. This can be done in the priming screen.
6. Press Priming Start button on screen and the control system will allow infusion
fluid to flow through the tubing set.
• At the end of this priming period, the tubing should be free of air bubbles.
• If any air bubbles remain, repeat priming process.
7. The Phaco Module will be automatically switched ON.
Priming :
• An advisory pop-up window is displayed when the phaco function is selected,
but not connected, or when no cassette is inserted.
• An advisory pop-up window is displayed when priming/testing has failed.
• If the Stop Key is pressed during priming, the priming is aborted.
• All Sub-Functions are available during priming.
8. Before starting every phaco surgery, check the irrigation/aspiration balance.
9. Compress the outside of the test chamber with your thumb and forefinger, and
then release it.
• Hold the phaco handpiece at the same level as the patient’s eye. Depress
main pedal on the footswitch to activate the Irrigation and Aspiration functions.
• The test chamber should return to its original position within a few seconds,
indicating a successful test.
• If the test chamber remains collapsed, check the infusion line, tubing set and
system settings.
• Repeat the previous steps until the test is successfully completed.
10. Once the test is successful, remove the test chamber from the end of the phaco
handpiece.
11. Select the phaco mode, set the output power using the UP and DOWN buttons.
• When in Pulse mode :
Set the pulse rate using the UP and DOWN buttons.
12. Select Linear or Dual Power.
13. The system is now ready for surgical use. Be sure that all system settings are at
the desired level before beginning the procedure.
14. Control the Phaco output using the third position on the main pedal of the
footswitch or the selected switch/button.
Warning !
The balance between irrigation and aspiration can be tested using a test
chamber. However, this does not simulate the effect of any wound
leakage. The flow rate for irrigation should equal to the flow rate of
aspiration plus an allowance for wound leakage. Because of this, wound
leakage should be kept to a minimum. A suggested setting is to place the
vented fluid level approximately at 65-75 cm. above the patient eye level.
The irrigation bottle may be positioned higher or lower than this
standard, depending on the size of the wound, surgical technique,
variances in ocular tissues and anterior chamber depth.
For Vitrectomy :
• Install I/A cartridge to the side panel of the
ASSOCIATE®.
• Connect the infusion bottle to the irrigation
tubing of the cartridge.
• Connect Irrigation/Aspiration tubing ends to
each other.
• Run priming cycle.
• Connect the infusion cannula to the infusion
line (blue connector).
• Connect the vitrectome (red connector) to
the aspiration line. Figure 41. Vitrectomy module
• Connect the vitrectome (white or transparent violet connector) to the cutter port of
the Vitrectomy Module.
• Check preset-values.
• In standard default use footswitch #2 to call for constant irrigation.
• Select program “standard” or program “reversed” (footswitch #7)
• Use footswitch main pedal to control the functions.
5.2 Description
The Vitrectomy Module provides an output for pneumatic high speed vitrectomes.
This output can produce a maximum frequency of 2,500 cuts per minute in pneumatic
mode. This module can provide linear or Dual control of vitrectomy cutting in
combination with linear control of aspiration.
• The peristaltic pump can produce a maximum vacuum of 500 mmHg and max.
50cc/min. flow independently from each other.
• The Venturi pump can produce a maximum vacuum of 500 mmHg.
• The upper limit can be selected using the preset control buttons.
• The actual vacuum level can be controlled up to the maximum, using the
footswitch.
Setting 1 :
Setting 2 :
In this example, the more the
footswitch is pressed down, the
cutting rate goes down and the
aspiration goes Up. This results in a
higher flow.
Figure 45. Setting 2
When the Vitrectomy Module is active, the 4 other main functions Phaco, I/A, Scissor
and VFE are available as well. See the separate module chapters for more
information.
1. Prepare the unit for use as described in the section on “General Instructions”.
2. Install I/A cartridge to the side panel of the ASSOCIATE®. Connect the infusion
bottle to the “giving set”. Connect the irrigation/aspiration tubing ends to each
other.
3. Check the height of the infusion bottle. The height between the drip chamber and
the patient eye level must be around 40 to 60 cm. If the optional electric infusion
pole is installed, this height can be adjusted from the screen and/or by the
Footswitch.
4. If the Global Intra-ocular Air Pressure System is to be used, connect the air tubing
to the irrigation bottle. Place the drip chamber just above the patient eye to secure
a positive eye pressure. Set the ASSOCIATE® Air pressure to 30-50 mmHg. This
can be done in the priming screen.
5. Connect vitrectome to the cutter port of the Vitrectomy module.
6. Press Priming Start button on screen and the control system will allow infusion
fluid to flow through the tubing set. At the end of this priming period, the tubing
should be free of air bubbles. If any air bubbles remain, press Exit and the
Priming Start button again.
7. The Vitrectomy and I/A modules are automatically switched ON. Connect the
aspiration tubing of the cartridge (red connector) to the aspiration tubing of the
vitrectome and connect the irrigation tubing (blue connector) to the irrigation
cannula.
8. Select the control program to be used for the Footswitch. Select in the Linear
program “standard” or “reversed”.
9. Before starting the Vitrectomy procedure, activate the constant irrigation. Use the
main pedal to control the vitrectomy procedure, as listed.
NOTE: Please use only vitrectomy instruments suitable for operating safely in
combination with the ASSOCIATE®. In doubt please contact your local
distributor.
• The switch will hold the scissors blades closed/opened, respectively. This
provides a method for insertion and removal of the scissors handpiece tips into
and out of the eye.
• Pressing the main pedal on the footswitch, the multiple cutting starts.
When the Scissor Module is active, the 4 other main functions Phaco, I/A,
Vitrectomy, and VFE are available as well. See the separate module chapters for
more information.
• When in the Sub-Functions like the Diathermy or the VFI, the linear Mode is
activated, the Phaco, Vitrectomy, Irrigation / Aspiration, Scissor and VFE Modules
are turned OFF.
o The Main Pedal is now used for the sub-Functions.
• The reverse is also true. When the main functions are activated, the Diathermy
and the VFI Linear Modules are turned back to Fixed (button/switch control).
7.1 Description
I/A-min function :
• Depress “I/A-min” icon to select I/A-min.
• Depress this icon for the second time to enable this function.
When the I/A Module is active, the 4 other main functions Phaco, Vitrectomy, Scissor
and VFE are available as well. See the separate module chapters for more
information.
• When in the Sub-Functions like the Diathermy or the VFI, the linear Mode is
activated, the Phaco, Vitrectomy, Irrigation / Aspiration, Scissor and VFE Modules
are turned OFF.
o The Main Pedal is now used for the sub-Functions.
• The reverse is also true. When the main functions are activated, the Diathermy
and the VFI Linear Modules are turned back to Fixed (button/switch control).
8.2 Description
• Set the maximum power, using the UP and DOWN preset buttons on the screen.
• Set mode “linear” or “fixed” diathermy power.
• Select the diathermy accessory and connect the cable to the diathermy port on
the front panel.
• In “Fixed” Mode : depress switch #4 to get maximum preset output.
In “Linear” Mode : depress the main pedal to get linear output.
• When the Linear feature on the Diathermy Module is activated, the Phaco,
Vitrectomy, Irrigation/Aspiration, Scissors and VFE Modules are turned OFF.
• The reverse is also true. When the Vitrectomy Module is activated, the linear
feature on the Diathermy Module cannot be activated.
• The Diathermy Module will only interact with the other modules when the Linear
switch is turned OFF.
1. Prepare the unit for use as described in the section on “General Instructions”.
2. Select the diathermy accessory to be used and assemble it.
3. Connect the cable for the accessory to the diathermy port on the front of the
console.
4. Turn ON the Diathermy Module by Anterior or Posterior button.
5. Set the maximum power using the UP and DOWN preset buttons (as a guideline,
start at 30 to 40% and make adjustments when necessary).
6. Diathermy starts automatically in fixed diathermy power mode controlled by switch
#4 on the footswitch.
7. Press linear button for linear controlled diathermy power mode controlled by the
main pedal on the footswitch.
NOTE: Please use only diathermy probes suitable for operating safely in
combination with the ASSOCIATE®. In doubt please contact your local
distributor.
9.2 Description
9.3.1 Hidden
In the programming screen the illumination screen can selected.
9.3.2 Standby/Active
If the illumination function is selected, the illumination can be placed in standby or
active mode on the main screen.
This Module includes a Triple-Port Light source which may be used simultaneously.
The set-up and operation procedures for each light source are identical.
1. Prepare the unit for use as described in the section on “General Instructions”
2. Select the fiber optic accessory to be used. Plug the connector into the port on the
front of the console. Do not pull the optical fiber itself. Be sure the light guide is
firmly in place before turning ON the unit.
3. Turn ON the power switch and allow the unit to warm up for 20 seconds before
using the Illumination Module.
4. When Illumination is desired, activate the light source by pressing the light icon.
Select HIGH or LOW intensity using the UP/DOWN buttons (50-100%).
Warning !
The halogen bulbs used in this unit become very hot when the unit is
operating. Before changing the bulb, shut OFF the unit and allow at least
5 minutes for the bulb to cool down. Never touch a hot bulb with your
bare fingers. Do not wear vinyl gloves, when working with a hot bulb.
Caution !
• Do not touch the mirror and lens near the bulb.
• Any fingerprints will reduce the amount of light produced by the unit.
• Remove any fingerprints using a lens cloth and alcohol.
Because prolonged intense light exposure can damage the retina, the use of the
device for ocular examination should not be unnecessarily prolonged, and the
brightness setting should not exceed what is needed to provide clear visualization of
the target structures. This device should be used with filters that eliminate UV
radiation (<400nm) and, whenever possible, filters that eliminate short-wave blue light
(<420nm).
The retinal exposure dose for a photochemical hazard is a product of the radiance
and the exposure time. If the value of radiance were reduced in half, twice the time
would be needed to reach the maximum exposure limit.
While no acute optical radiation hazards have been identified for illuminators, it is
recommended that the intensity of light directed into the patient’s eye be limited to the
minimum level which is necessary for diagnosis. Infants, aphakes and persons with
diseased eyes will be at greater risk. The risk may also be increased if the person
being examined has had any exposure with the same instrument or any other
ophthalmic instrument using a visible light source during the previous 24 hours.
This will apply particularly if the eye has been exposed to retinal photography.
10.1.1 Description
The Air Module provides an automatic air infusion system. The pressure can be
selected on the front panel of the module, and is indicated on the screen. The air is
delivered to the tubing set through an extended 0.22µm filter. During operations on
the posterior segment of the eye, which require fluid-gas exchange, the Air module
provides a constant flow of filtered air at the preset pressure.
Instrument Port :
• The instrument port, located under the screen, is a standard male luer lock fitting.
• A 0.22µm filter is connected to the instrument port, and the air tubing set is
connected to the filter.
3. Connect a three-way stopcock to the connector on the end of the air tubing.
Connect the infusion cannula to one side of the three-way stopcock and connect
the infusion tubing (blue connector) to the other side of the three-way stopcock.
4. Activate the Air Module by pressing the ON/OFF button/switch.
5. Set the Air pressure desired using the UP and DOWN preset buttons.
6. When the Air flow is desired for the Air-Fluid exchange.
Switch the three-way stopcock from infusion fluid to air.
NOTE : When replacing the infusion bottle, the air pressure can still be present
inside the bottle. Therefore please place empty bottle in upright position
first.
10.2.1 Description
• The GPC function provides via the Air Module an infusion system.
• The pressure can be selected on the front panel of the module, and is indicated
on the screen.
• The air is delivered to the tubing set through an external 0.22µm filter.
• During operations on the anterior and posterior segment of the eye, the GPC
function provides a constant and rapid flow of filtered air to the irrigation bottle and
keeps the preset pressure very accurate.
The GPC Function has via the Air Module the following controls :
Instrument Port :
• The instrument port, located under the screen, is a standard male luer lock fitting.
• A 0.22µm filter is connected to the instrument port, and the air tubing set is
connected to the filter.
If GPC is used, connect the air tubing set during the set-up by proceeding as follows:
1. Prepare the unit for use as described in the section on “General Instructions”.
2. Connect the air filter to the luer lock connector on the Air Module.
Connect the open end of the Air tubing to the filter.
3. Connect the male luer to the spike of the infusion set
4. Activate the Air Module by pressing the ON/OFF button/switch.
5. Set the Air pressure desired, using the UP and DOWN preset buttons.
6. Level the drip-chamber of the irrigation bottle just above the patient eye.
If GPC is used, and an Air-Fluid exchange will be performed during the surgical
procedure, connect the air tubing set during the set-up by proceeding as follows :
1. Prepare the unit for use as described in the section on “General Instructions”.
2. Mount the “Y” connector (1250-E) on the air module outlet.
3. Connect the air filter to the luer lock connector on the “Y” Connector.
Connect the open end of the Air tubing to the filter.
4. Connect a three-way stopcock to the connector on
the end of the air tubing. Connect the infusion
cannula to one side of the three-way stopcock and
connect the infusion tubing (blue connector) to the
other side of the three-way stopcock.
5. Connect a second air-tubing set.
6. Connect the air filter to the luer lock connector on
the “Y” Connector.
7. Connect the open end of the Air tubing to the filter.
Figure 66. “Y” connector (1250-E)
NOTE : The GPC / Tamponade procedure requires a Ø 0.3 mm. opening, e.g. a flute
needle, to remove the overpressure in the eye.
10.4.1 Description
• The GPC function provides an infusion system via the Air Module.
• The pressure can be selected on the front panel of the module and is indicated on
the screen.
• The air is delivered to the tubing set through an external 0.22µm filter. During
operations on the anterior and posterior segment of the eye the GPC Function
provides a constant and rapid flow of filtered air to the irrigation bottle and keeping
the preset pressure very accurate.
• The Tamponade function allows the surgeon to temporarily increase the eye
above normal by means of extra air pressure inside the irrigation bottle.
The Tamponade Function has via the Air Module the following controls :
• In example left:
The normal air/IOP pressure is 40 mmHg.
With tamponade ON, the pressure in the eye will
go to 70 mmHg.
• The Tamponade function can only work if the Air
Module is activated.
• Press the UP button to increase the pressure setting, and press DOWN to
decrease the pressure (the preset value increases or decreases in increments of
1 mmHg).
Auto OFF
• The Tamponade function has a build-in Timer function.
This will guarantee an automatic switch off of the
Tamponade function.
• The maximum timer function is 120 sec.
SOUND
• An audible sound will be generated if the tamponade
function is active.
The DELTA AIR+INF. function is very important if the step manager (3.9.10.4) is
used. If the step manager is used the system has several steps.
Each step has its own setting for the Air module and the Automatic Infusion Pole.
If the DELTA AIR+INF is switched off, the user can change the values of the the Air
Module and the Automatic Infusion Pole during surgery.
E.g.:
Step 1 has an Air setting of 30 mmHg
Step 2 has an Air setting of 35 mmHg
Step 3 has an Air setting of 30 mmHg
Step 4 has an Air setting of 20 mmHg
The User may change the Air value in Step 2 with 5 mmHg to 40 mmHg during
surgery. All the other steps are not changed.
With the DELTA AIR+INF activated the same action will change all 4 steps.
If step 2 is changed with 5 mmHg to 40 mmHg this will result in:
11.2 Description
• The V.F.I. (Viscous Fluid Injection) Module can be used with the direct method of
pressurizing a pre-filled 10mL syringe (1363-DD) or with the indirect method using
the (1363-D) V.F.I. accessory.
• This section provides a way of fixed or linear controlled injection of Viscous
Fluids.
• The system can inject Viscous Fluids with a viscosity of up to 5,000 centistokes.
Preset buttons
• The UP and DOWN buttons are used to set the desired injection pressure. Press
the UP button to increase the maximum level (5 BAR), and DOWN to decrease it
(0.5 BAR). The preset value increases or decreases in increments of 0.5 BAR.
VFI linear
• Depress the main pedal to get linear
output.
• All main functions are disabled.
Instrument ports
• The V.F.I. port is located under the screen and is designed for use with the
D.O.R.C. V.F.I. syringe accessory.
• It has a quick-connect fitting. This port is only active when the ON/OFF button for
the V.F.I. function is turned ON.
Delivery syringe
• This section of the syringe is filled with sterile silicone oil.
Syringe holder
• This part holds the two syringe assemblies together.
Pressure syringe
• This syringe is pressurized to provide mechanical power to operate the delivery
syringe.
A dual syringe holder (1363-D) is used for this procedure. The delivery syringe is
filled with sterile silicone oil. The pressure syringe remains empty. As air pressure is
applied to the assembly, the pressure syringe operates as a pressure cylinder to
provide mechanical power to operate the delivery syringe.
1. Fill the 20cc delivery syringe with sterile silicone oil or install a pre-filled 10mL
syringe using the 10mL adaptor.
2. Place the loaded delivery syringe and an empty disposable syringe in the holder.
3. Connect the pressure tube connector to the pressure syringe.
4. Connect the pressure tubing to the pressure tube connector at the end of the
assembly.
5. Connect the tubing of the silicone infusion plug or other instrument to the delivery
syringe.
6. Check to see that all connections are tight.
7. Close the syringe holder using the lock plate.
1. Prepare the unit for use as described in the section on “Pre-Operating Procedures
– General Instructions”.
2. Turn ON the V.F.I. Module using the ON/OFF switch for the V.F.I. section.
3. Select the correct injection pressure to match the viscosity of the silicone oil by
the UP and DOWN button (0.5-5.0 BAR).
4. The set-up may be tested using the “V.F.I.+” switch on the rear panel of the unit.
Or use the separate V.F.I. footswitch with ON/OFF function.
5. Once the set-up procedure has been completed, Viscous Fluid Injection can be
activated by pressing a dedicated switch/button on the footswitch (for fixed VFI) or
the main pedal on the footswitch (for linear controlled VFI).
• Depress the V.F.E. icon and set the aspiration level using the UP and DOWN
buttons.
• The main pedal of the footswitch provides linear control of the vacuum.
12.2 Description
V.F.E. Tab
• This button is used to bring the V.F.E.
Module forward.
When the V.F.E. is activated, the other functions are in standby. Select the other
functions to activate them. The VFE will be placed in standby.
1. Prepare the unit for use as described in the section on “Pre-Operating Procedures
– General Instructions”.
2. Activate the V.F.E. Module using the VFE icon Tab.
3. Select the correct aspiration level to match the viscosity of the silicone oil by the
UP and DOWN button 10-500 mmHg, in case of peristaltic pump up to 600 mmHg
and 1-50cc/min. flow.
4. Once the set-up procedure has been completed, viscous fluid extraction (VFE)
can be activated by pressing the main pedal of the footswitch for linear controlled
VFE.
Backflush Indicator
• This module includes the “automatic Backflush” and “active
Backflush” features explained in the Description.
Figure 84. Backflush indicator
2. It the function Cutting ON/OFF is displayed by: CUTTING ON & CUTTING OFF
Error Messages
Pop-up Text Condition Correction
Check if inlet air pressure is
correct (5-6 BAR). If inlet air
Actual VFI pressure not in line pressure is correct, press O.K. to
VFI FAILURE
with preset value remove pop-up message. If
message reoccurs, contact
D.O.R.C service department.
Check if inlet air pressure is
correct (5-6 BAR). If inlet air
pressure is correct, press O.K. to
AIR PRESSURE LOW Inlet air pressure is too low.
remove pop-up message. If
message reoccurs, contact
D.O.R.C service department.
Connect source pressure.
NO AIR PRESSURE
Inlet air pressure not connected. Press O.K. to remove pop-up
AVAILABLE
message.
Install phaco handpiece.
NO PHACO
No phaco handpiece detected in Press O.K. to remove pop-up
HANDPIECE
anterior mode. message.
CONNECTED
Restart priming cycle.
Switch ASSOCIATE® OFF and
ON. Check cartridge. Press O.K.
ASPIRATION Actual vacuum not in line with
to remove pop-up message. If
FAILURE preset value.
message reoccurs, contact
D.O.R.C service department.
Connect the ASSOCIATE®
footswitch.
Press O.K. to remove pop-up
Footswitch is defect or not message.
PEDAL FAILURE
connected. Check footswitch cable. Replace
footswitch. If message reoccurs,
contact D.O.R.C service
department.
Check if air filter is connected. If
AIR FAILURE Air module error. message reoccurs, contact
D.O.R.C service department.
CONTAINER FULL.
REPLACE Stop surgery a.s.a.p., empty
CONTAINER. Cartridge full and aspiration will cartridge. After cartridge is
ASPIRATION WILL be stopped in 10 seconds. emptied, press O.K., to remove
BE DISABLED IN 10 pop-up message.
SECONDS
Replace vitrectome
ELEC. VITRECTOMY handpiece/cable.
Error on vitrectome and/or cable.
FAILURE Press O.K. to remove pop-up
message.
A halogen bulb is burned-out (and Replace bulb (see section 9.5)
LAMP FAILURE automatically switches to back-up Restart ASSOCIATE® (ON/OFF
bulb) switch).
LAMP MOTOR Automatic back-up bulb switch Contact D.O.R.C. service
FAILURE error. department.
Error Messages
Pop-up Text Condition Correction
Check if inlet air pressure is
correct (5-6 BAR). If inlet air
FLUID AIR Actual pressure not in line with pressure is correct, press O.K. to
EXCHANGE FAILURE preset value. remove pop-up message. If
message reoccurs, contact
D.O.R.C service department.
®
® Switch OFF the ASSOCIATE
TEMPERATURE TOO Temperature inside ASSOCIATE
and contact D.O.R.C. service
HIGH too high, error cool system.
department.
Automatic infusion pole is not
Connect automatic infusion pole
connected to ASSOCIATE® (in
INFUSION POLE to rear panel of ASSOCIATE® (or
combination with enabled
FAILURE disable automatic infusion pole in
automatic infusion pole in system
system settings).
setting).
Install or re-install cartridge.
CONTAINER NOT IN Cartridge is not (properly)
Press O.K. to remove pop-up
POSITION installed.
message.
Open & check infusion line and
Infusion line of “giving set” is re-start priming cycle.
NO IRRIGATION
closed. Press O.K. to remove pop-up
message.
Install or replace proportional
Proportional scissors not
NO PROP. scissors handpiece.
connected, or error in proportional
SCISSORS Press O.K. to remove pop-up
scissors / handles
message.
Check the tubing and re-start the
priming cycle. The irrigation line
should be connected to the
The equipment is not able to
aspiration line. The infusion line
PRIMING FAILURE complete the priming routine
should be open and the cartridge
successfully.
installed properly.
Press O.K. to remove pop-up
message.
The surgeon is able to complete
the current function, if only
footswitch control is needed.
The communication between the To re-establish communication
COMMUNICATION
user interface and the functional the unit should be restarted.
ERROR
control board has been lost. Press O.K. to remove pop-up
message. If message reoccurs,
contact D.O.R.C service
department.
These instructions are intended for use only by persons with the required specialist
knowledge and training.
NOTE: Aluminium alloy may be recognized by bright coloured (red, purple, blue,
frosted grey, gold/yellow, green, black) coatings on metallic
components.
WARNINGS
The DORC instruments and medical devices have been designed to provide the
ophthalmic surgeon with an array of products for the manipulation of very delicate
tissues.
Aluminium based instruments are damaged by alkaline (pH>7) detergents and
solutions. Do not use hydrogen peroxide on titanium instruments or on anodized
surfaces in order to avoid decolourisation. Wherever possible avoid use of mineral
acids and harsh, abrasive agents.
Do not flush with any fluid that might leave a residue, such as a saline solution.
Only detergents and cleaners specially designed for use on surgical stainless steel or
titanium instruments are acceptable for use in the cleaning process.
The cleaning guidelines of the solution manufacturer and your institution should be
observed.
Devices with long, narrow cannulas, hinges and blind holes require particular
attention during cleaning. Please use the additional instructions, when supplied.
Do not exceed 140°C (284°F).
Silicone oil is extremely difficult to completely remove from the silicone accessories.
Therefore, if silicone oil is used in the surgical procedure, all silicone parts that come
in contact with the silicone oil, should be replaced.
Limitations on reprocessing
Repeated processing has minimal effect on these instruments. End of life is normally
determined by wear and damage due to use. Thorough cleaning immediately after
use is essential for the longevity of the instrument or medical device.
INSTRUCTIONS
Point of use:
During surgery the instrument or medical device comes in contact with various
substances including intraocular fluids, blood and membranes. If the instrument or
medical device is not cleaned immediately after use, this can lead to inferior
performance or failure of the product. To prevent drying of these substances to the
product immerse it in a container filled with distilled or demineralized water.
The instruments and medical devices should be washed clean of all residues, dried
and inspected after each use.
Cleaning: Manual
Please use the additional instructions, when supplied.
1. If necessary, clean the instrument or medical device with a detergent or cleaner;
2. Wash the instrument or medical device thoroughly by rinsing with distilled water;
3. Clean the exterior of the instrument carefully using a soft bristle brush or surgical
sponge moistened with 70% alcohol. Avoid direct contact with delicate and
sensitive parts;
4. Wipe the exterior handle of the instrument dry with a lint free cotton tissue or use
dry filtered oil-free compressed air.
Cleaning: Automated
Please use the additional instructions, when supplied.
Ultrasonic Cleaning Equipment:
An ultrasonic cleaner could also be used in the instrument or medical device cleaning
process, but not as the sole cleaning method. The instrument should, at the very
least, be flushed with distilled water prior to being placed in the ultrasonic cleaner.
A five to ten minutes cycle in the ultrasonic cleaner should be sufficient. The
instrument or medical device must be secured on a silicone finger mat during the
ultrasonic cleaning procedure. Special care should be taken to prevent the product
from coming into contact with the sides of the ultrasonic container, as this would
damage the product.
Disinfection:
Disinfection of the instrument or medical device is highly recommended, before a
final sterilization process. Use 70% alcohol as described in the Cleaning: Manual
section or if automated cleaning is employed, a final rinse at 80°C (176°F) for 10
minutes may be used to effect thermal disinfection.
Never use the instrument or medical device without a final sterilization process.
Drying:
It is imperative that as much moisture is eliminated from all of the instrument parts or
medical device, since moisture promotes corrosion of the product.
Using an automated washer-Disinfector Machine a drying cycle of 20 minutes and
cooling down to maximum 40°C (104°F) is recommended.
Packaging:
The instruments and medical devices should be placed in a proper container to
protect the instruments during sterilization. Wrap the trays using an appropriate
method to maintain sterility afterwards. A well sealed peel pouch (ISO 11607-2) fit for
the sterilization process is such an appropriate method.
Packaging of instruments and medical devices could be subject to local protocols.
Sterilization:
The instrument or medical device should be sterilized before the next surgical
procedure shortly after the cleaning process. The instrument or medical device can
be sterilized using any of the following methods:
Steam autoclaving:
Sterilizer type : Gravity-displacement Prevacuum
Sample config. : wrapped wrapped
Temperature : 121°C – 123°C 132°C – 135°C
Temperature US : (250°F to 254°F) (270°F to 275°F)
Exposure time : 15 – 30 minutes 6 – 30 minutes
Storage:
Ensure instruments and medical devices are dry before storage, and stored in dry,
clean conditions at ambient room temperature.
Additional Information:
When sterilizing multiple products in one autoclave cycle ensure that the sterilizer’s
maximum load is not exceeded. Following the manufacturer’s instructions only use
distilled or demineralized water in the autoclave.
The instructions provided above have been validated by the manufacturer of the
medical device as being CAPABLE of preparing a medical device for re-use.
It remains the responsibility of the processor to ensure that the reprocessing as
actually performed using equipment, materials and personnel in the reprocessing
facility achieve the desired result. This normally requires validation and routine
monitoring of the process. Likewise any deviation by the processor from the
instructions provided should be properly evaluated for effectiveness and potential
adverse consequences.
1. Turn OFF the power switch on the back of the unit. Unplug the power cord.
2. The fuses are located on the rear of the unit, inside the black box at the point
where the power cord is attached. The fuse cover has two tabs.
3. Remove the old fuses. Replace them with two new fuses of the same type :
The fuse type is also listed on the label on the back of the unit.
4. Plug-in the power cord and turn ON the power switch on the back of the unit.
5. Important ! If the new fuses fail quickly, there may be something wrong with the
unit. Please call D.O.R.C. International b.v. for instructions.
D.O.R.C. International b.v. recommends that you keep the following parts on hand.
If a problem develops, this will allow you to return the equipment to service quickly.
Part Description
Lamp bulb 24V – 150 Watt
Fuse – 230/240V 3.15A slow-blow
Fuse – 100/120V 6.3A slow-blow
Table 2 – Recommended Spares
Annual inspection: Inspect mains inlet, Equipotential connection and power cord for
damages and insulation resistance.
1. Before returning the equipment to D.O.R.C. International b.v. for service, please
contact the Service Department :
Phone : ++31-181-458080
Fax : ++31-181-458090
E-mail : sales@dorc.nl
Web-site : www.dorc.nl
2. Please try to protect the equipment as much as possible during shipping. It is best
to use the original packaging if it is available.
Section 16 – Specifications
GENERAL
Apparatus : ASSOCIATE®
Type :
Compact Version : 6600
Dual Version : 6700
Weight : 35 Kg.
Dimensions :
Console : 50 x 50 x 36 cm.
Display : 10.1 inch
INPUT
Mains supply : 100VAC~/120VAC~50/60Hz
230VAC~/240VAC~50/60Hz
VITRECTOMY MODULE :
Pneumatic Cutting range : 100-2500 cuts/minute linear (+/- 10%)
Electric Cutting range : 100-1500 cuts/minute linear (+/- 10%)
SCISSORS MODE :
Scissors Cutting Range : 60-600 cuts/minute
Proportional Scissors Mode : 0-100% linear open/close action
PHACO EMULSIFICATION/
FRAGMENTATION MODULE :
Power Consumption : 50 Watts
Frequency : 40 kHz
Auto-tuning
DIATHERMY MODULE :
Output : (values at room temperature)
RF Output : 0-7.5 Watts, 100 Ω (1 MHz) loaded,
linear and fixed output
Frequency : 1 MHz, crystal controlled
AIR MODULE :
Air Pressure : from 0-120 mmHg.
VFI MODULE :
Pressure : from 0.5-5.0 BAR, linear or fixed pressure
VFE MODULE :
Aspiration : Venturi 10-500 mmHg
Peristaltic pump 10-600 mmHg,
also 1-50 cc/min. aspiration flow
ENVIRONMENT :
Operation :
a) An ambient temperature range of +10°C to +40°C.
b) A relative humidity range of 10% to 85% without condensation.
c) An atmospheric pressure range of 700 hPa to 1060 hPa.
DISPOSAL :
The user (owner) of the DORC ASSOCIATE® is responsible for a safe and
environmental friendly disposal of the ASSOCIATE® after its service life.
Please note that the product does not contain any dangerous materials.
Its disposal will not damage the environment and will not put at risk staff
charged with the disposal itself. As an extra safety precaution, we recommend
to contact the waste local services and/or the competent authorities in order to
be properly informed about the disposal of the device.
Symbols used
The following symbols are used in and on the ASSOCIATE®:
Type BF equipment
Rx Only US Federal law restricts this device to sale by on the order of a licensed
physician only.
Alternating current
Non-ionizing radiation
Scissors function
Air function
Diathermy function
Section 17 – Warnings
A warning indicates a potentially harmful situation to yourself or others.
Explosion hazard
• Never use the ASSOCIATE® in the presence of flammable aesthetics.
Electrostatic discharge through the printed circuit boards will damage the
components of the ASSOCIATE®. Handle all circuit boards (replacements and
defective) by their non-conductive edges and use anti-static containers, when
transporting them. Before servicing the equipment, ground yourself and the tool to
discharge any accumulated static charge, by wearing a static tool wrist strap. Use
hospital-grade grounded receptacle only.
Servicing of this products, in accordance with the Service Manual, should never be
undertaken in the absence of proper tools, test equipment and the most recent
revision of the Service Manual, which must be clearly and thoroughly understood.
Do NOT apply tension to the line cord. Check rear panel voltage setting before
connecting the ASSOCIATE® to AC main power.
NEVER IMMERSE THIS UNIT IN LIQUID !!!!
Section 18 – Warranty
• D.O.R.C. International b.v. warrants that all possible care was used in the choice
of materials and manufacture of its products.
• The D.O.R.C. International b.v. warranty will not be valid in case non-original
D.O.R.C. accessories and/or spare parts are used !
• D.O.R.C. International b.v. shall not be liable for any incidental or consequential
loss, damage or expense, arising from abuse of its products. However, if D.O.R.C.
International b.v.’s investigation shows that its products were defective at the time
of shipment by D.O.R.C. International b.v., products will be replaced/repaired at
no charge.
• Otherwise all D.O.R.C. International b.v. equipment is covered with a full year
warranty, which does not cover the accessories.
• D.O.R.C. International b.v. neither assumes nor authorizes any other person to
assume for it, any other or additional liability or responsibility in connection with its
products.
Cautions
- A caution indicates a condition that may lead to equipment damage or
malfunction.
- Note that portable and mobile communication equipment can affect
medical electrical equipment
The Associate is intended for use in the electromagnetic environment specified below. The customer or the user
of the Associate should assure that it is used in such an environment.
RF emissions The Associate uses RF energy only for its internal function. Therefore,
Group 1 its RF emissions are very low and are not likely to cause any
CISPR 11 interference in nearby electronic equipment.
RF emissions The Associate is suitable for use in all establishments other than
Class B domestic and those directly connected to the public low-voltage power
CISPR 11 supply network that supplies buildings used for domestic purposes.
Harmonic emissions
Class A
IEC 61000-3-2
Voltage fluctuations /
flicker emissions Complies
IEC 61000-3-3
The Associate is intended for use in the electromagnetic environment specified below. The customer or the user
of the Associate should assure that it is used in such an environment.
<5 % UT <5 % UT
Voltage dips, short Mains power quality should be that of a typical
interruptions and (>95 % dip in UT) (>95 % dip in UT) commercial or hospital environment. If the user
voltage variations for 0,5 cycle for 0,5 cycle of the Associate requires continued operation
on power supply during power mains interruptions, it is
input lines 40 % UT 40 % UT recommended that the Associate be powered
(60 % dip in UT) (60 % dip in UT) from an uninterruptible power supply or a
IEC 61000-4-11 battery.
for 5 cycle for 5 cycle
70 % UT 70 % UT
(30 % dip in UT) (30 % dip in UT)
for 25 cycle for 25 cycle
<5 % UT <5 % UT
(>95 % dip in UT) (>95 % dip in UT)
for 5 sec for 5 sec
Power frequency Power frequency magnetic fields should be at
(50/60 Hz) levels characteristic of a typical location in a
magnetic field 3 A/m 3 A/m typical commercial or hospital environment.
IEC 61000-4-8
NOTE: UT is the a.c. mains voltage prior to application of the test level.
The Associate is intended for use in the electromagnetic environment specified below. The customer or the user
of the Associate should assure that it is used in such an environment.
IEC 61000-4-6 150 kHz to 80 MHz where P is the maximum output power rating of the
transmitter in watts (W) according to the transmitter
manufacturer and d is the recommended separation
distance in meters (m).
Radiated RF 3 V/m 3 V/m
Field strengths from fixed RF transmitters, as
80 MHz to 2,5 GHz determined by an electromagnetic site survey,a
IEC 61000-4-3 should be less than the compliance level in each
b
frequency range.
Interference may occur in the vicinity of equipment
marked with the following symbol:
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
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land
mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically
with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic
site survey should be considered. If the measured field strength in the location in which the Associate is used
exceeds the applicable RF compliance level above, the Associate should be observed to verify normal
operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting
or relocating the Associate.
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
The Associate is intended for use in the electromagnetic environment in which radiated RF disturbances are
controlled. The customer or the user of the Associate can help prevent electromagnetic interference by
maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and
the Associate as recommended below, according to the maximum output power of the communications
equipment.
100 12 12 23
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in
meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the
maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1: At 80 MHz and 800 MHz, the separation distance for 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.
Footswitch lay-out :
Sub-functions Active
Footswitch lay-out :
Sub-functions Active
1 Step program
Table 5 – Posterior Venturi
Function Mode footswitch Cuts/ Power Aspiration Vacuum Infusion
Min mode mmHg Pole
Setting
Vitrectomy Pneu/Lin Standard 800 Linear 200 70
Scissor Elec/Lin 200 - 65
Phaco Linear 20 % Linear 200 70
IA Linear Linear 100 70
VFE Linear Linear 500 70
Footswitch lay-out :
Sub-functions Active/Standby
1 Step program
Table 6 – Posterior Peristaltic
Function Mode footswitch Cuts/ Power Aspiration Flow Vacuum Infusion
Min mode cc mmHg Pole
Setting
Vitrectomy Pneu/Lin Standard 800 Linear 12 200 70
Scissor Elec/Lin 200 - 65
Phaco Linear 20 % Linear 25 200 70
IA Linear Linear 25 100 70
VFE Linear Linear 20 500 70
Footswitch lay-out :
Sub-functions Active
Sub Button/Switch
Function
Diathermy 4
Light -
Air -
VFI 2
Footswitch lay-out :
Sub-functions Active
Footswitch lay-out :
Sub-functions Active
Footswitch lay-out :
Sub-functions Active
Footswitch lay-out :
Sub-functions Active
Footswitch lay-out :
Sub-functions Active
Footswitch lay-out :
Sub-functions Active
Footswitch lay-out :
Footswitch lay-out :
Sub-functions Active
Footswitch lay-out :
Sub-functions Active
Sub Button/Switch
Function
Diathermy 4
Light -
Air -
VFI -
Footswitch lay-out :
Sub-functions Active
A.15 Oil In
Table 16 – Oil in
Step Function mode footswitch Power Aspiration Vacuum Flow Infusion
mode mmHg CC Pole
Setting
1 Vitrectomy Pneu Linear 1500 cuts Linear 250 - 40
2 Oil In Pneu Linear 5 bar - - - 40
Footswitch lay-out :
Sub-functions Active
Footswitch lay-out :
Sub-functions Active
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