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2500

Ophthalmic Surgical System


Instruction Manual

D.O.R.C. International b.v. Dutch Ophthalmic USA

Scheijdelveweg 2 10 Continental Drive, Bldg 1


3214 VN Zuidland Exeter, NH 03833
The Netherlands U.S.A.

Phone : ++31-181-458080 Phone : 800-75-DUTCH or 603-778-6929


Fax : ++31-181-458090 Fax : 603-778-0911
E-mail : sales@dorc.nl E-mail : sales@dutchophthalmicusa.com
Web-site : www.dorc.nl

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

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D.O.R.C. ASSOCIATE-2500® Instruction Manual

Section 7 – Irrigation / Aspiration Module........................................................................................43


7.1 Description...........................................................................................................................43
7.2 Controls and Indicators ........................................................................................................43
7.3 Control interactions with other modules ...............................................................................44
Section 8 – Diathermy Module ..........................................................................................................45
8.1 Quick-Start Instructions........................................................................................................45
8.2 Description...........................................................................................................................45
8.3 Controls and Indicators ........................................................................................................46
8.4 Control Interactions with other modules ...............................................................................46
8.5 Operating Procedure............................................................................................................46
Section 9 – Triple Port Illumination Module.....................................................................................47
9.1 Quick-Start Instructions........................................................................................................47
9.2 Description...........................................................................................................................47
9.3 Controls and Indicators ........................................................................................................47
9.3.1 Hidden.........................................................................................................................47
9.3.2 Standby/Active ............................................................................................................48
9.4 Operating Procedure............................................................................................................48
9.5 Changing a Halogen Bulb ....................................................................................................49
9.6 Compliance with FDA required information to the user ........................................................50
Section 10 – Air Module/GPC (Global Pressure Control) Module / Tamponade function ............51
10.1 Quick-Start Fluid/Air- Exchange Instructions........................................................................51
10.1.1 Description ..................................................................................................................51
10.1.2 Controls and Indicators................................................................................................51
10.1.3 Operating Procedure ...................................................................................................52
10.2 Quick-Start GPC Instructions ...............................................................................................53
10.2.1 Description ..................................................................................................................53
10.2.2 Controls and Indicators................................................................................................54
10.2.3 Operating Procedure ...................................................................................................54
10.3 Combination Fluid/Air-Exchange with GPC function ............................................................55
10.4 Tamponade Function with GPC ...........................................................................................55
10.4.1 Description ..................................................................................................................55
10.4.2 Controls and Indicators................................................................................................56
10.5 Programming the Air Module/Tamponade/Delta Air + Inf. Function .....................................57
10.6 Default Programs .................................................................................................................58
Section 11 – Viscous Fluid Injection Module...................................................................................59
11.1 Quick-Start Instructions........................................................................................................59
11.2 Description...........................................................................................................................59
11.3 Controls and Indicators ........................................................................................................60
11.4 Set-up Instructions ...............................................................................................................61
11.5 Operating Instructions..........................................................................................................62
11.6 Programming the VFI function .............................................................................................62
11.7 Default Procedures ..............................................................................................................63
Section 12 – Viscous Fluid Extraction Module ................................................................................64
12.1 Quick-Start Instructions........................................................................................................64
12.2 Description...........................................................................................................................64
12.3 Controls and Indicators ........................................................................................................64
12.4 Control interactions with other modules ...............................................................................65
12.5 Operating Procedure............................................................................................................65
12.6 Programming the VFE Module.............................................................................................65
12.7 Default Procedures ..............................................................................................................65
Section 13 – Special Indicators & Pop-Up Error Code Messages ..................................................66
Section 14 – Cleaning & Sterilizing Instructions for Reusable Accessories.................................69
Section 15 – Service Instructions .....................................................................................................73
15.1 Replacing the Fuses ............................................................................................................73
15.2 Recommended Spare Parts.................................................................................................73
15.3 Periodical Instructions for Preventive Inspection and Maintenance......................................73
15.4 Returning the Unit for Service..............................................................................................74
Section 16 – Specifications...............................................................................................................75
Section 17 – Warnings.......................................................................................................................79
Section 18 – Warranty .......................................................................................................................80

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D.O.R.C. ASSOCIATE-2500® Instruction Manual

Section 19 - Electromagnetic Compatibility (EMC) .........................................................................81


Appendix - A Default Settings ASSOCIATE® ............................................................................85
A.1 Anterior Venturi (Classic) .....................................................................................................85
A.2 Anterior Peristaltic (Classic) .................................................................................................86
A.3 Posterior Venturi (Classic) ...................................................................................................86
A.4 Posterior Peristaltic (Classic) ...............................................................................................87
A.5 Phaco D&C Venturi (GPC)...................................................................................................88
A.6 Phaco D&C Peristaltic (GPC)...............................................................................................88
A.7 Phaco Chop Venturi (GPC)..................................................................................................89
A.8 Cool Phaco Venturi (GPC) ...................................................................................................89
A.9 SoftSonic Phaco Venturi (GPC) ...........................................................................................90
A.10 Combi 20G Venturi (GPC) ...................................................................................................90
A.11 Combi 23G Venturi (GPC) ...................................................................................................91
A.12 Dual Vitrectomy 23 G (GPC)................................................................................................92
A.13 Combi Dual 23G (GPC) .......................................................................................................93
A.14 Posterior Peristaltic 23G (GPC) ...........................................................................................93
A.15 Oil In ....................................................................................................................................94
A.16 Oil Out .................................................................................................................................94
Appendix - B Quick Programming.............................................................................................95
Appendix - C Footswitch Reminder...........................................................................................97

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D.O.R.C. ASSOCIATE-2500® Instruction Manual

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 function modules are :


• Phaco-Emulsification /
Fragmentation Module
• Vitrectomy Module
• Scissors Module
• Irrigation/Aspiration Module
• Diathermy Module
• Triple Port Illumination Module
• Air Module
• VFI Module
• VFE Module

Figure 1. The ASSOCIATE®

These modules can be used as a single function, or in combination. Functions of


some of the modules are interactive. For example, when the Phaco & Vitrectomy
Module is activated, the Irrigation/Aspiration Module is activated as well. A footswitch
provides a convenient way of controlling several modules at once.

To provide the ophthalmic surgeon the optimum convenience, the ASSOCIATE® is


equipped with a dual pump system, Peristaltic and Venturi selectable for both anterior
and posterior surgery.

Color LCD Display and Touch Screen


The display and touch screen show the icons and buttons
with which the user interacts with the system. An icon or
button is selected and activated when the user presses
that region of the screen where it is displayed. A sterile
drape can be used over the touch screen so the
ASSOCIATE® can be operated with sterile surgical gloves.

Figure 2. Color LCD Display and Touch Screen®

Instrument Receptacle LED’s


There are LED’s located next to their respective connectors on the front of the
console. These LED’s have dual functions :
• During surgery set-up, when the operator selects a probe, handpiece or
accessory, the corresponding LED is turned on to guide the operator to the
correct connection location.
• During surgery, these LED’s are used to indicate which connections are
active.
The ASSOCIATE® may be ordered with a trolley and automatic infusion pole.

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D.O.R.C. ASSOCIATE-2500® Instruction Manual

High Vacuum Sensor Cartridge


The ASSOCIATE® operates on one cartridge suitable for Peristaltic and Venturi
aspiration system and is suitable for both anterior and posterior segment surgery. An
integrated microprocessor guarantees an optimal intraocular vacuum in surgery.

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.

The ASSOCIATE® vitreoretinal system is certified by KEMA with respect to Electric


Shock, Fire, Mechanical and other specified hazards only in accordance with
• IEC 60601-1:1988, A1:1991, A2:1995 Class 1 Type BF
• IEC 60601-2-2:1998
EMC :
• IEC 60601-1-2: 2001, A1:2006

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D.O.R.C. ASSOCIATE-2500® Instruction Manual

Section 2 – Controls and Features

2.1 Overall Views of the unit


10
1) Triple-port light connector
2) Scissors connector
3) Proportional scissors connector
4) VFI connector
5) Air connector
6) Pneumatic vitrectome connector
7) Electric vitrectome connector
1 8) Phaco connector
9) Diathermy connector
10) ON/OFF indicator

Figure 3. ASSOCIATE® - Front View

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

Figure 4. ASSOCIATE® - Rear View

2 3 4 5 6 7 8

Figure 5. ASSOCIATE® - Side View (with


cartridge set in place)

Handle to release cartridge

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D.O.R.C. ASSOCIATE-2500® Instruction Manual

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

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D.O.R.C. ASSOCIATE-2500® Instruction Manual

The Footswitch is fully programmable.


• Besides the main pedal, the Footswitch has 4 Push Buttons and 4 Switches.
• It is possible to program each button or switch. To change the functions of the
Buttons and Switches, go to the programming section in the Main Menu and
press the footswitch Button.

Press Memory

Press the Footswitch Button

Select the change mode: “ONLY THIS STEP” or


”ALL STEPS SAME”

“ONLY THIS STEP” allows changing one footswitch


step only, the actual footswitch step.

“ALL STEPS SAME” copies the complete actual


footswitch step settings to all steps.

Select the button or switch.

Select the requested function

Figure 7. Footswitch is fully programmable

For restoring default settings go to Appendix A.

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D.O.R.C. ASSOCIATE-2500® Instruction Manual

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.

2.3 Remote Control

The ASSOCIATE® is standard supplied with an infra-red remote


control to select and control all surgical functions without touching the
user’s interface screen.

The ASSOCIATE® Remote Control can be placed in a sterile bag to


be used in the sterile field for surgeon and/or operating staff.
By depressing the UP/DOWN, LEFT/RIGHT button, cursor lights up
and is skipping to the next function mode.

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.

NOTE : The remote control is only functional in the main menu,


priming and surgical screens.
Figure 8. Remote control

2.4 User or Operator Instructions for cleaning the ASSOCIATE®

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®.

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D.O.R.C. ASSOCIATE-2500® Instruction Manual

Section 3 – General Instructions


The following sections outline steps required to set up the ASSOCIATE® prior to
surgical use. Please review this section carefully before preparing the system. Also,
refer to the following sections for additional information on the operation of a specific
module.

3.1 Preparing the Unit for Use

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.

NOTE : In case of the automatic infusion pole is used, install connecting


cable between ASSOCIATE® and automatic infusion pole.

3.2 Pre-Operating Procedure

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).

3.3 Installation Irrigation/Aspiration Cartridge (6279-ASC)

• Install the I/A cartridge to the


side panel of the
ASSOCIATE®,
• Connect the infusion bottle to
the “giving set” of cartridge.
Phaco Mode :
• Connect the Irrigation /
Aspiration tubing ends to the
phaco handpiece connectors
(phaco handpiece complete
with needle, sleeve and test
chamber).
All Other Modes :
• Connect the Irrigation /
Aspiration tubing-ends to each other.

Figure 9. Irrigation/Aspiration Cartridge

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D.O.R.C. ASSOCIATE-2500® Instruction Manual

3.4 Select SURGEON MEMORIES

3.4.1 Surgeon Name


It is possible to store 16 different Surgeons/Users

Selecting a Surgeon Program:

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.

Figure 10. Storage of 16 different Surgeons/Users

3.4.2 Surgeon Settings


• Each Surgeon has the possibility to store 16 different procedures
• Selecting a procedure in Surgeon Settings :
1. Press on the Main Menu the circle of the Surgeon Settings
2. 16 memory fields come up. Select the desired procedure. For a new
procedure press cancel and use the programming section to create a new
procedure.

Figure 11. 16 different procedures for each Surgeon/User

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D.O.R.C. ASSOCIATE-2500® Instruction Manual

3.5 Priming

The priming program is a routine to prepare the system for surgery.

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.

Figure 12. Priming 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.

• On “ending” the priming procedure, the selected surgical mode automatically


appears.

The system is now ready for surgery and the


requested functions and pre-settings can be
activated by depressing black color function icons.

NOTE : However, before starting the phaco


emulsification procedure, it is necessary to check if
the Irrigation/Aspiration balance is correct by using
the phaco test chambers (product # 3007)

Figure 13. Ending priming procedure

Warning :
If the cartridge is not installed correctly, the unit may not function
properly.

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D.O.R.C. ASSOCIATE-2500® Instruction Manual

3.6 Change of Pump System

• 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

The Cleaning button is available in the Main Menu.


Cleaning procedure transfers fluid from the tubing into the cartridge.

• When the “Clean” key is pressed, the cleaning screen pops up :

Figure 14. Cleaning procedure

• 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.

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D.O.R.C. ASSOCIATE-2500® Instruction Manual

3.8 System Settings

In the Main Menu select the button “System Settings”.


The following settings are available :

• (Main) Pedal
• Sound
• Time
• Function (modules)
• Service
• Language

Figure 15. System settings

3.8.1 (Main) Pedal

This is a Service Screen.


The Footswitch Settings can be changed in the
programming mode.

Figure 16. (Main) Pedal

3.8.2 Sound

In the sound system setting mode, the loudness of the following functions can be
programmed :

• Alarm
• Voice
• Others

• Adjust the requested loudness level from 0 till


10 by depressing the UP/DOWN button.
• Depress SAVE M+ button to memorize the
selected settings.

Figure 17. Sound mode

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D.O.R.C. ASSOCIATE-2500® Instruction Manual

3.8.3 Time

• In the Time Mode, the date and time can be


programmed.
• Adjust the requested date and time by
depressing the HIGH/LOW buttons, depress
SAVE M+ button to memorize the settings.
• Depress EXIT to come back in the Main Menu.

Figure 18. Time Mode

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.

• Depress function mode button :


o Light blue function is disabled
o Dark blue function is enabled

• Depress SAVE M+ button to memorize the


settings and depress EXIT to come back in the
Main Menu.

Note: all 3 modes are standard disabled, and


system is preset in pneumatic mode.
Figure 19. System Mode

3.8.5 Service

• Only for Authorized Service Technicians

Figure 20. Service

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D.O.R.C. ASSOCIATE-2500® Instruction Manual

3.8.6 Language

In the Language Mode, the following text (written & spoken) can be selected :

• English / German / French / Italian or Spanish


• Depress the requested language button and the
requested language will change from light blue
into dark blue.
• Depress SAVE M+ button to memorize the
settings and depress EXIT to come back in the
Main Menu.

Figure 21. Language Mode

3.9 Programming

It is possible to store 16 different Users with each 16 different memory programs

3.9.1 Quick Programming


For Quick programming of new users, go to the Quick Programming sheet in
appendix B

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D.O.R.C. ASSOCIATE-2500® Instruction Manual

3.9.2 Program a new User


To create a new user without a procedure setting:

a. Switch ON the ASSOCIATE® and the welcome


screen appears. Touch the screen. The Main
Menu appears.

b. Press “MEMORY” in the programming field

c. Click on an empty position in the “Select User”


screen.

d. Type the new user name and confirm by


pressing “OK”. The new User is now created.
e. Press EXIT to return to the main menu or add a
procedure.
• To add a procedure go to chapter 3.9.3

Figure 22. Program a new user

3.9.3 Programming using default settings

The ASSOCIATE® has 16 Default programs (see appendix A)


• The default programs are a good basis to start from.
• The settings are safe and based on years of experience.

The surgeon’s personal experience can be added to create the perfect surgical
procedure.

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D.O.R.C. ASSOCIATE-2500® Instruction Manual

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. In case the surgeon does not have its own
program, go to Chapter 3.9.2 and add a new user.

4) Press an empty field in the “select memory” screen.

5) The programming screen appears.


6) Press the default button.

Select a default.
7) Press the save memory button
8) Type a name for the Procedure

Figure 23. Programming using default settings

Warning :
Please check all modifications to the programming prior to actual
surgery!

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D.O.R.C. ASSOCIATE-2500® Instruction Manual

3.9.4 Adjusting Existing Procedures

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.

3.9.5 Copy Existing Procedure


1) Switch ON the ASSOCIATE® and the welcome
screen appears. Touch the screen.
The Main Menu appears.
2) Press “Programming”
3) Select the Surgeon’s program in the “Select
User” screen.
4) Select the procedure to be changed in the
“Select Memory” screen. The programming
screen appears.
5) Press the SAVE M+ button
6) Press the “New Memory” position for copying the
existing procedure to a new procedure.

Figure 24. Copy Existing Procedure NOTE : it is not possible to copy a user.

3.9.6 Rename User

1) Switch ON the ASSOCIATE® and the welcome screen appears.


Touch the screen. The Main Menu appears.
2) Press “Programming”
3) Select the “Document” circle in the “Select User” screen.
4) Type the new name.
5) Press the “OK” button to save.
6) Press cancel to return to the Main Menu screen.
Figure 25. Select user

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D.O.R.C. ASSOCIATE-2500® Instruction Manual

3.9.7 Rename Procedure

1) Switch ON the ASSOCIATE® and the welcome screen appears.


Touch the screen. The Main Menu appears.
2) Press “Programming”
3) Select the Surgeon’s program in the “Select User” screen.
4) Select the “Document” circle in the “Select Memory” screen
5) Type the new procedure name.
6) Press the “OK” button to save.
7) Press cancel to return to the “Select User” screen. Figure 26. Select Memory
8) Press cancel to return to the Main Menu screen.

3.9.8 Remove User

1) Switch ON the ASSOCIATE® and the welcome screen appears.


Touch the screen. The Main Menu appears.
2) Press “Programming”
3) Select the “Document” circle of the user to be deleted in
the “Select User” screen.
4) Press the Delete button.
5) Press the “OK” button to confirm.
6) Press cancel to return to the Main Menu screen. Figure 27. Select User

3.9.9 Remove Procedure

1) Switch ON the ASSOCIATE® and the welcome screen appears.


Touch the screen. The Main Menu appears.
2) Press “Programming”
3) Select the Surgeon’s program in the “Select User” screen.
4) Select the “Document” circle of the procedure to be
deleted in “Select Memory”
5) Press the delete button
6) Press the “OK” button to confirm.
7) Press cancel to return to the “Select User” screen. Figure 28. Select Memory
8) Press cancel to return to the Main Menu screen.

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D.O.R.C. ASSOCIATE-2500® Instruction Manual

3.9.10 Advanced Programming

In advanced programming the individual functions are explained.

3.9.10.1 Footswitch functions

• The footswitch functions are very useful to custom


program the footswitch. Each button or switch can
have a different function.
• The default settings are listed in appendix A.
• It is possible to have 1 function on multiple positions.

Figure 29. Footswitch functions


INACTIVE
• The inactive function is very important, it basically deactivates a button switch.
• It is very useful to make the footswitch more simple

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.

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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.

BACKFLUSH / SCISSORS HOLD


• The Backflush Function creates a reverse flow through the aspiration tubing.
The function remains active as long as the switch/button is depressed.
o To stop the function, release the button/switch.
• In the Scissors Mode the aspiration mode is not active. For this reason the
backflush function changes. The function changes to Scissors Hold. The Scissors
Hold function closes the scissor and keeps it closed.
o Depress the button/switch to close the scissor.
o The function remains active as long as the switch/button is depressed.
o To open the scissor, release the button/switch.

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.

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VISCOUS FLUID INJECTION


• The VFI function (Viscous Fluid Injection) can be activated in the fixed mode.
Depress the button/switch. The function remains active as long as the
button/switch 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.

PHACO DUAL MODE


• The Dual Mode function removes the Phaco function from the main pedal to a
button/switch.
• In this way the aspiration is independently controlled from the main function,
Phaco
• To activate the Phaco, keep the Phaco Dual Mode button/switch activated.

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CONSTANT IRR. / VFI


• The Constant Irrigation / VFI button is a combination switch which allows to have
two functions (Constant Irrigation and Viscous Fluid Injection) on the same button.
• When the VFI is on standby, the Constant Irrigation mode is active and the VFI
function does not work. As soon as the VFI module is activated, the function of
the switch will be the VFI On mode. On the screen both functions are selectable.

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.

The options are set :


• only for a procedure,
• not for the whole system,
• not for the complete user programs
• and not per step.

Figure 30. Select options screen

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

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3.9.10.3 Footswitch User Settings

In the programming screen is the button for selecting the Footswitch User Settings.

Figure 31. Select Footswitch User Settings

The main pedal of the footswitch can be programmed in the following settings :

• Threshold positions, step 1


and 2 :
Press 1 : adjust first resistant
point in %
Press 2 : adjust second
resistant point in %

• 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.

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Linear Button (Dual Vitrectomy)


Behind the Linear Button is the user setting for Dual
Mode for Vitrectomy Only.

In the Dual Mode it is possible to control


the aspiration and cutting at the same
time from a starting threshold to an
ending threshold.

• Press 1 : adjust starting point in %


• Press 2 : adjust ending point in %

Figure 33. Programming Linear Main Pedal of the footswitch

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.

3.9.10.4 Step Manager

With the Step Manager it is possible to create 10 different function screens in a


procedure.
• Since the operations have more and more routine elements, it is desirable to
remember these routine steps.
• For example the classic phaco procedure, divide and conquer, is known for a 3
step procedure:
o Step 1 grooving,
o Step 2 removal of quadrants
o Step 3 IA cortex removal.

Figure 34. Step manager

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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 Appendix A1.1-A1.2 the step selector is manually programmed in 4 steps.


• Note: Step 4 is capsule polishing.

The step screens are as below:

Figure 35. Step manager to program routine steps

• In the default programs, the steps are already inside. Go to Chapter 3.8.3

• In appendix C you will find a chart for preparing the programs.

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Section 4 – Phaco Module

• The ASSOCIATE® system is capable to perform Phaco Emulsification and Phaco


Fragmentation.
• With the introduction of Cool Phaco & SoftSonic
the limitations of Phaco Emulsification and
Phaco Fragmentation have changed
completely.
• Different power levels are possible without the
risk to burn cornea or sclera.
• The wide variety of needles and sleeves allow
incisions from 3.2 mm to 1.0 mm.
Figure 36. Phaco Module

4.1 Quick-Start Instruction


This section is included as a reminder for readers who are already familiar with the
unit. For more complete instructions, see the following sections.
• Assemble the phaco handpiece & attach the tubing set of the cartridge.
• Connect the test chamber on the phaco handpiece to check the I/A balance.
• Connect the infusion bottle to the “giving set” of the cartridge.
• Connect (if requested) the GPC system to the air outlet and the giving set.
• Select the User Program and Procedure.
• Depress the priming button and wait till priming is finished.
• Phaco Module appears automatically.
• Perform Irrigation & Aspiration balance test by using the test chamber. Press
DOWN the main pedal and check if the test chamber shows appropriate pressure
at patient eye level.
• Disconnect the test chamber.
• Use the footswitch to control the phaco function.

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.

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Phaco :

• 40 kHz phaco technology with continuous auto-tuning.


• Pulse mode from 1-125 Pulses with 10-50% duty ON cycle
• SoftSonic for Micro Coaxial Phaco and Phaco Fragmentation with 10-50% duty
ON cycle.
• Multiburst for “digging into the lens” with 1 to 100 pulses.
• Cool phaco for M.I.C.S. micro incision cataract surgery.
• Phaco dual mode with simultaneous control of aspiration and phaco.
• Phaco Emulsification and Phaco Fragmentation.
• Peristaltic pump :
o High vacuum occlusion technology for advanced capsular protection.
• Venturi pump :
o Selectable vacuum rise time.

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)

Figure 37. Phaco modes

High Vacuum Sensor Cartridge


The ASSOCIATE® operates on one cartridge suitable for Peristaltic and Venturi
aspiration system and is suitable for both anterior and posterior segment surgery.
An integrated microprocessor guarantees an optimal intraocular vacuum in surgery.

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4.3 Controls and Indicators

For Phaco function :


• Select the Phaco Mode
o Continuous Mode
o Pulse Mode
ƒ Set the pulse rate using the UP and DOWN
buttons.
ƒ Set the duty On Cycle (only programming
mode)
o Multi Burst Mode
ƒ Set the amount of Pulses using the UP and
DOWN buttons Figure 38. Phaco mode
o Cool Phaco Mode
o SoftSonic Mode
ƒ Set the duty On Cycle using the UP and DOWN Buttons

• Set mode Linear or Dual phaco power.


o Linear Phaco is controlled over the main pedal of the footswitch.
o The movement is downwards only and is activated in position 3.
Dual phaco allows the user to activate the phaco power on a button or a
switch.
This function separates the phaco power from the aspiration. It is possible to
control the phaco power independent from the aspiration.

NOTE : It is not possible to create phaco power with zero aspiration.


A minimum flow or vacuum has to be present.

• 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.

For Aspiration function :


• Select Peristaltic or Venturi Pump.
• Set max. vacuum value (mmHg) using the UP and DOWN buttons.

In case of Peristaltic Pump, also :


• Set the linear or fixed flow.
• Set the max. aspiration flow value (cc/min.) using the UP
DOWN buttons.
• A phaco needle with max. ID of 0.7 mm has to be used.

In case of Venturi Pump, also :


• Set the linear or fixed aspiration
• Set the rising time in case of fixed aspiration.
• A phaco needle with max. ID of 0.7 mm has to be used.

Figure 39. Rise Time Selection Screen

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For Irrigation function :


• Set infusion pole height using the UP and DOWN buttons
(only when automatic infusion pole is connected).
• Set the Global Intra-ocular Air Pressure Control (GPC) using the UP and DOWN
buttons (only when the air function is activated).
• Use panel control or footswitch control (to be programmed) to activate the
constant irrigation ON/OFF.

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.

4.4 Control interactions with other modules

• 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).

4.5 Operating Procedure (Classic Phaco )

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.

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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.

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4.6 Phaco Settings

Depending on the phaco procedures it is to be advised to reduce the amount of


phaco power as much as possible. For this reason, modes like cool phaco &
SoftSonic have been introduced. In appendix A.1 guideline settings to the surgeon
are described. However, it is the surgeon’s responsibility to fully understand the result
of the preset values and the result of any adjustment made at it.

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.

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4.7 Cleaning an occluded phaco handpiece

An occluded ultrasonic handpiece or tubing will result in a not-aspirating system and


a blockage of the cooling mechanism. If the system is used at high energy levels it
may result in damage at the incision site. An occlusion could occur in the handpiece,
or at the Y connection at the aspiration pinch valve. Should an occlusion occur, take
the following steps :

• Install a standard three-way stopcock between the aspiration tubing on the


ASSOCIATE® and the aspiration port on the phaco handpiece.
• Fill a syringe with sterile saline solution and attach it to the third port of the three-
way stopcock.
• During normal operation, the handle on the stopcock should be in the position
shown to allow the aspiration fluid to flow from the phaco handpiece to the
ASSOCIATE®.
• If the aspiration tubing becomes
blocked, you can use this apparatus to
force the fluid through the aspiration
tubing port of the phaco handpiece in
the reverse of the normal direction.
Set the three-way stopcock so the fluid
from the syringe is directed into the
phaco handpiece. Use the pressure
from the syringe to backflush the
handpiece.
• Set the three-way stopcock so fluid will
flow to the ASSOCIATE® again. Press
the button on the Aspiration valve
shown in Fig. 4. This will draw the fluid
through the aspiration tubing and into
the collection bottle.
Figure 40. Three-way stopcock

NOTE: Please use only phaco emulsification and fragmentation probes


suitable for operating safely in combination with the ASSOCIATE®.
In doubt please contact your local distributor.

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Section 5 – Vitrectomy Module


Standard the system is set for pneumatic vitrectomy. It is possible to change the
pneumatic vitrectomy mode to an electric vitrectomy mode.
See chapter: 3.8.4 Modules for changing from pneumatic to electric and vice versa.
Please note that the electric vitrectome will run with a max cutting speed of 1500
cuts/min. the pneumatic vitrectome has a cutting speed of max. 2500 cuts/min.
In Section 5 – Vitrectomy Module, the Pneumatic Vitrectome is used in all examples.
If the electric vitrectome is used, read instead of pneumatic vitrectome: electric
vitrectome. The functions are identical. Just the driving mechanism is different.

5.1 Quick-Start Instructions


This section is included as a reminder for readers who are already familiar with the
unit. For more complete instructions, see the following sections.

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.

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5.2.1 Linear Control

In the Linear Mode the system has two possibilities


Standard Mode or Reverse Mode.
With the footswitch or on the touch screen the Standard or
Reversed vitrectomy mode can be selected :
• Standard Mode : for procedures which require minimal
aspiration.
The footswitch movement in standard procedures is: first
linear cutting frequency followed by linear aspiration.
Figure 42. Standard mode

• Reversed Mode : for procedures which require first


aspiration and then cutting.
The footswitch movement in reversed procedures is: first
linear aspiration followed by linear cutting frequency.

Figure 43. Reversed mode


“Standard” Program selected :
• 1st Step : Irrigation ON
• 2nd Step : Linear control of vitrectomy, followed by :
• 3rd Step : Linear control of aspiration
“Reversed” Program selected :
• 1st Step : Irrigation ON
• 2nd Step : Linear control of aspiration, followed by :
• 3rd Step : Linear control of vitrectomy

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5.2.2 Dual Control

In the Dual Mode the system has two important settings.


The Start Position: Setting 1 and End Position: Setting 2.

The Footswitch travels from Setting 1 to Setting 2.

Setting 1 :

In this example the system starts


with high speed cutting and low
aspiration. It creates a low flow and
is ideal for entrance and shaving
techniques.

Figure 44. Setting 1

By pressing down the footswitch, in


a linear way, the system change
towards setting 2.

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

5.3 Controls and Indicators

For Vitrectomy cutting :


• Set mode Linear or Dual vitrectomy.
• Set the max. cutting rate (cpm), using the UP and DOWN buttons and switch
between the Dual Settings 1 and 2 if applicable.

For Aspiration function :


• Select Peristaltic or Venturi Pump.
• Set max. vacuum value (mmHg) using the UP and DOWN buttons.

In case of Peristaltic Pump, also :


• Set the linear or fixed flow.
• Set the max. aspiration flow value (cc/min.) using the UP DOWN buttons.

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In case of Venturi Pump, also :


• Set the linear or fixed Aspiration.
• Set the rising time in case of fixed aspiration.

For Irrigation function :


• Set infusion pole height using the UP and DOWN buttons
(only when automatic infusion pole is connected).
• Set the Global Intra-ocular Air Pressure Control using the UP and DOWN buttons
(only when the air function is activated)
• Use panel control or footswitch control (to be programmed) to activate the
constant irrigation ON/OFF.

5.4 Control Interactions with other modules

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.

• 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).
Figure 46. Control interaction

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5.5 Operating Procedure – Posterior Vitrectomy

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.

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Section 6 – Scissors Module

6.1 Scissors Mode

The Scissors mode provides multiple cutting


capability using electric powered scissors
(1267-HS + 1267-MPC) controlled by the footswitch.

Figure 47. Scissors mode


The scissors function has the following characteristics:
• The mode is entered when the Scissors key is pressed.
• Standard the footswitch has no dedicated button or switch.
• The Backflush / Scissors function has a double function. In scissors mode it holds
the scissors closed if activated.
• The main pedal will activate the cutting action.
• To use the scissor mode go to the programming chapter 3.8 to select a
button/switch. A logic choice would be switch #5.

Figure 48. Footswitch mode

• 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.

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6.2 Proportional Scissors Mode

The Proportional Scissors sub-mode provides


proportional control of the opening and closing of
the scissors blades using the electric powered
proportional scissors (1268-MPC).
• Representation of Scissors closure is indicated
at the Users Interface.
• When footswitch is in rest position, scissors are
fully open = 0%
• When footswitch is at full treadle down, scissors
are fully closed = 100%
Figure 49. Proportional Scissors mode

6.3 Control interactions with other modules

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).

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D.O.R.C. ASSOCIATE-2500® Instruction Manual

Section 7 – Irrigation / Aspiration Module

7.1 Description

The I/A mode generates vacuum by a


selectable peristaltic or venturi pump.

• The I/A mode also provides I/A min. mode


for capsule cleaning, selectable by the
ON/OFF switch on the screen.
• Constant irrigation ON/OFF is controlled by
the ON/OFF switch on the screen or
footswitch command. The irrigation flow is
regulated by the height of the infusion pole.
• The Peristaltic pump can produce a flow of
50 cc/min maximum and in occlusion mode
a vacuum of 500 mmHg.
• 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.

Figure 50. Irrigation / Aspiration Module

7.2 Controls and Indicators

For Aspiration function :


• Select Peristaltic or Venturi Pump.
• Set max. vacuum value (mmHg) using the UP and DOWN buttons.

In case of Peristaltic Pump, also :


• Set the linear or fixed flow
• Set the max. aspiration flow value (cc/min.) using the UP and DOWN buttons.

In case of Venturi Pump, also :


• Set the linear or fixed Aspiration
• Set the rising time in case of fixed aspiration.

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.

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For Irrigation function :


• Set infusion pole height using the UP and DOWN buttons.
(only when automatic infusion pole is connected).
• Set the Global Intra-ocular Air Pressure Control using the UP and DOWN buttons
(only when the air function is activated)
• Use panel control or footswitch control (to be programmed) to activate the
constant irrigation ON/OFF.

7.3 Control interactions with other modules

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).

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D.O.R.C. ASSOCIATE-2500® Instruction Manual

Section 8 – Diathermy Module

8.1 Quick-Start Instructions

This section is included as a reminder for readers who


are already familiar with the unit. For more complete
instructions, see the following sections :
• Connect the accessory to be used.
• Turn ON the Module.
• Set the maximum power using the UP and DOWN
buttons.
• Select linear control if desired.
• If linear control is selected :
Use the main pedal on the Footswitch for linear
control.
• If fixed control is selected :
Use switch # 4 on the Footswitch to call for fixed
preset power.

Figure 51. Diathermy mode

NOTE : Already during the priming cycle, the diathermy function is


continuously standby.

8.2 Description

The Diathermy Module provides selective burn


placement for anterior and posterior segment surgery.
The diathermy energy is produced by a crystal-
controlled solid-state oscillator. The output is regulated
so that the diathermy energy remains constant at the
pre-selected value. The output of the Diathermy
Module can be controlled in fixed or linear mode by
using the footswitch.
Figure 52. Diathermy module

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8.3 Controls and Indicators

• Set the maximum power, using the UP and DOWN preset buttons on the screen.
• Set mode “linear” or “fixed” diathermy power.

NOTE : Fixed diathermy remains stand-by, in combination with all other


functions. Linear diathermy is only functional as stand-alone
function and will automatically switch OFF the phaco, vitrectomy,
irrigation / aspiration, VFE and linear VFI functions.

• 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.

NOTE : a blue indicator is lighting up at the moment the diathermy is activated.

8.4 Control Interactions with other modules

• 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.

8.5 Operating Procedure

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.

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D.O.R.C. ASSOCIATE-2500® Instruction Manual

Section 9 – Triple Port Illumination Module

9.1 Quick-Start Instructions

This section is included as a reminder for readers


who are already familiar with the unit. For more
complete instructions, see the following sections.
• Connect the accessory to be used.
• Active/Standby switch to turn light ON,
UP and DOWN button to set light intensity.

Figure 53. Triple Port Illumination Module

9.2 Description

The Triple Port Illumination Module is intended to provide


intraocular illumination using 20G probes during vitreo-retinal
surgery. The module includes three light source outlets to use
three illumination accessories simultaneously. The light output of
the source can be controlled using the Active/Standby switch and
the UP/DOWN selector on the screen. The light module will
accept a wide range of D.O.R.C. fiber optic accessories.

Figure 54. Intraocular illumination

9.3 Controls and Indicators

The Triple Port Illumination Module has 2 screen possibilities.


Hidden, and Standby/Active

9.3.1 Hidden
In the programming screen the illumination screen can selected.

Figure 55. Selection options illumination

Screen appearance, the illumination is


hidden.

Figure 56. Illumination hidden

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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.

Figure 57. Illumination standby and active

The illumination module has the following controls and indicators :

Active /Standby Switch


Depress the Light icon button to activate the Triple Port Illumination Module.

UP/DOWN Light Intensity Output


The Triple Port Illumination Module contains UP/DOWN buttons which control the
light intensity from 50-100%.

Fiber Optic Triple-Port connector

NOTE: Please use only Triple Port fiber illumination


probes suitable for operating safely in
combination with the ASSOCIATE®. In doubt
please contact your local distributor.

Figure 58. Triple-port connector

9.4 Operating Procedure

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%).

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9.5 Changing a Halogen Bulb

In the event of a bulb burn-out, the Illuminator icon is changed to a broken


lamp bulb icon. The illumination module automatically switches to the
second back-up bulb.
Figure 59. Broken Lamp Bulb Icon

NOTE : At the end of the procedure, it is recommended that the burned-out


bulb be replaced so that a back-up light source is always available.

Changing a Halogen Bulb :


1. Unplug the power cord of the
ASSOCIATE®. Allow about 5 minutes
for the bulb to cool down.
2. Open cover-lid on the left monitor side.
3. Turn inner protection cover to the left to
enter light module.
4. Remove the defective bulb eccentric
from the optical system.
5. Install a new halogen bulb
(24 Volt/150 Watt)
6. Close protection cover and cover lid.
7. Plug-in the power cord again
Figure 60. Changing a Halogen Lamp Bulb

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.

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9.6 Compliance with FDA required information to the user

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.

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D.O.R.C. ASSOCIATE-2500® Instruction Manual

Section 10 – Air Module/GPC (Global Pressure Control) Module /


Tamponade function

10.1 Quick-Start Fluid/Air- Exchange Instructions

This section is included as a reminder for readers who are


already familiar with the unit.
For more complete instructions, see the sections below :
• Connect the 0.22µm filter and air tubing to the module.
• Connect a three-way stopcock to the end of the tubing.
Connect the infusion cannula to one port, and the
infusion tubing (blue connector) to the other port of the
three-way stopcock.
• Turn ON the Air Module. Set the Air pressure using the
UP and DOWN buttons.
Figure 61. Air Module

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.

10.1.2 Controls and Indicators

The Air Module has the following controls :

ON/OFF Button (Panel control)


• The ON/OFF button is used to activate or
de-activate the Air Module.

ON/OFF Button/switch (Footswitch control)


• The ON/OFF button/switch is used to
activate or de-activate the Air Module.
Figure 62. Air module footswitch controls
UP/DOWN Buttons (Panel Control)
• The UP/DOWN buttons are used to select the pressure of the air delivered by the
module.
• The air pressure is adjustable from 0 to 120 mmHg.
• 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).

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UP/DOWN Buttons (Footswitch Control)


• The UP/DOWN buttons are used to select the pressure of the air delivered by the
module.
• The air pressure is adjustable from 0 to 120 mmHg. 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 5 mmHg).

Air Calibration Pop-up :


• When the actual value is higher or lower than the preset value an Air-Calibration
Pop-up screen appears.

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.

10.1.3 Operating Procedure

If 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. Connect the air filter to the luer lock connector on the Air
Module.
Connect the open end of the Air tubing to the filter.
Figure 63. Air module controls and indicators

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.

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10.2 Quick-Start GPC Instructions

This section is included as a reminder for


readers who are already familiar with the unit.
For more complete instructions, see the
sections below.
• Connect the 0.22µm filter and air tubing to
the air module.
• Connect the luer-end to the spike of the
infusion cannula.
• Turn ON the Air Module. Set the Air
pressure using the UP and DOWN buttons.
• Level the drip chamber just above the
patient eye.
®
Figure 64. ASSOCIATE with GPC System

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.

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10.2.2 Controls and Indicators

The GPC Function has via the Air Module the following controls :

ON/OFF Button (Panel control)


• The ON/OFF button is used to activate or de-activate the Air Module.

ON/OFF Button/switch (Footswitch control)


• The ON/OFF button/switch is used to activate or de-activate the Air Module.

UP/DOWN Buttons (Panel Control)


• The UP/DOWN buttons are used to select
the pressure of the air delivered by the
module.
• The air pressure is adjustable from 0 to 120
mmHg. 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).
Figure 65. Air module Footswitch Control
UP/DOWN Buttons (Footswitch Control)
• The UP/DOWN buttons are used to select the pressure of the air delivered by the
module.
• The air pressure is adjustable from 0 to 120 mmHg. 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 5 mmHg).

Air Calibration Pop-up :


• When the actual value is higher or lower than the preset value an Air-Calibration
Pop-up screen appears.

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.

10.2.3 Operating Procedure

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.

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10.3 Combination Fluid/Air-Exchange with GPC function

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)

8. Connect the male luer to the spike of the infusion set


9. Activate the Air Module by pressing the ON/OFF button/switch.
10. Set the Air pressure desired using the UP and DOWN preset buttons.
11. Level the drip-chamber of the irrigation bottle just above the patient eye.
12. When the Air flow is desired for the Air-Fluid exchange, switch the three-way
stopcock from infusion fluid to air.

10.4 Tamponade Function with GPC

• If GPC is used, it is possible to tamponade the eye by means of increased bottle


pressure.
• The setup is identical to the GPC setup.

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.

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10.4.2 Controls and Indicators

The Tamponade Function has via the Air Module the following controls :

Tamponade ON/OFF Button (Panel control)


• The ON/OFF button is used to activate or de-activate the tamponade Function

• 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.

Figure 67. Tamponade mode

ON/OFF Button/switch (Footswitch control)


• The ON/OFF button/switch is used to
activate or de-activate the Tamponade
Function.

UP/DOWN Buttons (Panel Control)


• The UP/DOWN buttons are used to select
the pressure of the air delivered by the
module.
• The air pressure is adjustable from 0 to 120
mmHg.
Figure 68. Air module Footswitch Controls

• 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).

UP/DOWN Buttons (Footswitch Control)


• The UP/DOWN buttons are used to select the pressure of the air delivered by the
module.
• The air pressure is adjustable from 0 to 120 mmHg. 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 5 mmHg).

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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.

Figure 69. Timer function

NOTE : The GPC / Tamponade procedure requires a Ø 0.3 mm opening, e.g. a


flute needle, to remove the overpressure in the eye.

10.5 Programming the Air Module/Tamponade/Delta Air + Inf. Function

• The Air Function, the Tamponade and the


Delta Air + Inf. function are selectable in the
option section of the programming.
• Press Memory and select the option button.

Figure 70. Programming the Air Module/Tamponade/Delta Air+ Inf. Function

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:

Step 1 the Air setting changes from 30 to 35 mmHg


Step 2 the Air setting changes from 35 to 40 mmHg
Step 3 the Air setting changes from 30 to 35 mmHg
Step 4 the Air setting changes from 20 to 25 mmHg

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• To obtain footswitch control, a switch/button on the footswitch must be set.

It is possible to control on the footswitch:


• Air UP
• Air DOWN
• Air ON/OFF
• Tamponade ON/OFF

Figure 71. Footswitch control

10.6 Default Programs

• In the Default screen some procedures are


provided with the GPC function.
• Behind the procedure it is mentioned in
brackets.(GPC)

Figure 72. Default Programs

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D.O.R.C. ASSOCIATE-2500® Instruction Manual

Section 11 – Viscous Fluid Injection Module

11.1 Quick-Start Instructions

• Fill and assemble the V.F.I. syringe. Connect the


pressure tube to the V.F.I. connector.
• Turn ON the V.F.I. section of the module on the
screen.
• Select the injection pressure using the UP and DOWN
buttons.
• Select “Linear” or “Fixed” V.F.I.
• The “VFI+” switch on the rear of the unit may be used
to test the set-up without using the footswitch. Figure 73. V.F.I. module
• Use the footswitch to start fixed Viscous Fluid Injection.

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.

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11.3 Controls and Indicators

The V.F.I. module has the following controls :

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.

Figure 74. VFI Linear


VFI fixed
• It is possible to get fixed preset output.
• A Switch/button on the footswitch has to be
dedicated to this function.
• The Main Function remains available.
Figure 75. VFI fixed

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.

V.F.I.+ switch (rear panel)


• This switch may be used to activate the V.F.I. feature during a set-up. It turns ON
the output required to drive the V.F.I. syringe.
• Once the VFI section of the module has been turned ON, the V.F.I.+ switch
provides the same function as pressing the dedicated button on the footswitch.
This avoids the necessity of using the footswitch during the set-up process.

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11.4 Set-up Instructions

Reusable System (indirect method)

Delivery syringe Syringe holder Pressure syringe Pressure tube


(silicone oil) (empty) connector

Figure 76. Syringe with sterile silicone oil

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.

Pressure tube and connector


• This part of the assembly is connected to the V.F.I. port on the front panel.

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.

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Disposable System (direct method)


• Connect the pressure tubing to the system (instructions are inside the package of
the pressure tubing).
• Place the pre-filled oil syringe in the holder of the pressure tubing.

11.5 Operating Instructions

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).

11.6 Programming the VFI function

• The VFI Function is selectable in the option


section of the programming.
• Press Memory and select the option button.

Figure 77. Programming the VFI function

To obtain footswitch control, a switch/button on the


footswitch must be set.

Figure 78. Footswitch control

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11.7 Default Procedures

In the Default screen there is a pre-programmed setting with Oil-In. :

Figure 79. Default screen

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D.O.R.C. ASSOCIATE-2500® Instruction Manual

Section 12 – Viscous Fluid Extraction Module

12.1 Quick-Start Instructions

This section is included as a reminder for


readers who are already familiar with the unit.
For more complete instructions, see the
following section.

For V.F.E. functions


• Connect the V.F.E. pack 1362-D to the
aspiration tubing (red connector) of the
cartridge.
Figure 80. Viscous Fluid Extraction Module

• 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

• The V.F.E. Module generates a vacuum by Venturi or Peristaltic pump which


provides aspiration to remove intraocular viscous fluids.
• The VFE Module is one of the 5 main functions in the system.
• The peristaltic pump can produce a maximum vacuum of 600 mmHg and
maximum 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.

12.3 Controls and Indicators

V.F.E. Tab
• This button is used to bring the V.F.E.
Module forward.

Switch & Buttons


• The VFE pump functions are identical to the
Irrigation / aspiration functions described in
Section 7.
• Please refer Section 7 for descriptions of the
pump functions.
Figure 81. Footswitch Controls

To activate the V.F.E., use the main pedal of the footswitch.

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12.4 Control interactions with other modules

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.

Set-up and Operating Procedure

For V.F.E. functions


• Connect the V.F.E. pack 1362-D to the aspiration tubing of the cartridge (red
connector).
• 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.

12.5 Operating Procedure

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.

12.6 Programming the VFE Module

• The VFE Function is selectable in the option


section of the programming.
• Press Memory and select the option button.

Figure 82. Selection options

12.7 Default Procedures

In the Default screen the last procedures is


pre-programmed for Oil Out.

Figure 83. Default screen

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D.O.R.C. ASSOCIATE-2500® Instruction Manual

Section 13 – Special Indicators & Pop-Up Error Code Messages

Full Cartridge Indicator


The pop-up screen with full cartridge indicator will come up when the cartridge on the
side of the unit is full (see fig. 3). A sensor determines whether the container is full.

Backflush Indicator
• This module includes the “automatic Backflush” and “active
Backflush” features explained in the Description.
Figure 84. Backflush indicator

• A Backflush indicator on the screen appears if the Backflush feature is activated.

Automatic Infusion Pole


HIGH and LOW buttons
• The HIGH/LOW switches are used with the optional electric
infusion pole.
• By pressing the UP or DOWN switch on the screen or
footswitch, the operator can raise or lower the infusion pole.

Figure 85. Automatic Infusion Pole

Footswitch function display


The footswitch functions are displayed at the screen.
1. The actual position of the main pedal of the footswitch is displayed by 1, 2 or 3
indicators.

Figure 86. Actual Footswitch position display

2. It the function Cutting ON/OFF is displayed by: CUTTING ON & CUTTING OFF

Figure 87. Cutting function ON/OFF

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D.O.R.C. ASSOCIATE-2500® Instruction Manual

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.

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D.O.R.C. ASSOCIATE-2500® Instruction Manual

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.

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D.O.R.C. ASSOCIATE-2500® Instruction Manual

Section 14 – Cleaning & Sterilizing Instructions for Reusable


Accessories

Instructions for initial use


It is essential that the instruments and devices are cleaned and sterilized before initial
use following the procedures as outlined in this instruction manual. Washing, drying
and inspecting the instrument or medical device under magnification helps to ensure
that the product is kept in optimum condition for the next surgical procedure.

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.

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D.O.R.C. ASSOCIATE-2500® Instruction Manual

Preparation for decontamination:


Remove and discard single use, replaceable (silicone) parts. Medical waste is subject
to local protocols and national or regional regulations.
Further disassembly is not required. Please use the additional instructions, when
supplied.
If the instrument has a locking device or a reversed action mechanism (tip is closed
in resting position) the instrument has to be set in a position that the tip is open
during cleaning.

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.

After ultrasonic cleaning, steps 2 to 4 of the “Cleaning: Manual” section should be


followed.

Automated Washer-Disinfector Machine:


Do not clean the instrument inside a closed sterilization tray, however the sterilization
tray should also be cleaned, if used.
If the manufacturer of the Washer-Disinfector provides an ophthalmic rack, please
use this accessory.
Please use protection caps or accessories to flush lumens when supplied with the
instrument or medical device. Place instruments with concave surfaces facing down
to prevent pooling of water.

The following cycle parameters are recommended as a minimum:


1) cold water rinse cycle < 35°C (95°F) during 4 minutes;
2) detergent cycle during 6 minutes:
a) at 70°C (158°F) for 0.5% high alkaline cleaner (pH > 10.5);
b) at 55°C (131°F) for 0.5% enzymatic cleaner;
3) warm water rinse cycle > 40°C (104°F) during 3 minutes;
4) warm water rinse cycle > 40°C (104°F) during 2 minutes.

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D.O.R.C. ASSOCIATE-2500® Instruction Manual

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.

Maintenance, Inspection and Testing:


After cleaning, visually inspect all surfaces, cannulations, ratchets, joints, holes and
lumens for complete removal of soil and fluids. If any soil or fluid is still visible, the
cleaning process must be repeated.
The instruments and medical devices should be carefully inspected under
magnification for any possible wear or damage prior to sterilization. Discard worn and
damaged instruments and medical devices immediately.
Apply surgical grade lubricants to hinges, joints and moving parts, which do not come
in contact with the patient, as per the lubricant manufacturer’s instructions.

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:

100% Ethylene oxide sterilization:


Concentration EO : 625 ± 75mg/l
Temperature : 37°C – 47°C (99°F to 117°F)
Exposure time : 3 – 4 hrs.
Humidity : 70% RH minimum

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

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D.O.R.C. ASSOCIATE-2500® Instruction Manual

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.

Note: If an instrument or medical device is returned to the manufacturer or the local


representative, the instrument must be decontaminated and sterilized and be
accompanied with the relevant documented evidence (a chemical sterility
indicator according to ISO 11140-1 is sufficient evidence).

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.

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D.O.R.C. ASSOCIATE-2500® Instruction Manual

Section 15 – Service Instructions

15.1 Replacing the Fuses

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 :

Voltage Fuse Dimensions


230/240V T3.15A slow-blow
5 x 20 mm.
100/120V T6.3A slow-blow
Table 1 – Fuse Replacement

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.

15.2 Recommended Spare Parts

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

15.3 Periodical Instructions for Preventive Inspection and Maintenance

Periodical instructions for preventive inspection besides user or operator cleaning


instructions (see 2.4 / page 8):

Annual inspection: Inspect mains inlet, Equipotential connection and power cord for
damages and insulation resistance.

Service manual is available on request through your local distributor or at D.O.R.C.


International b.v.

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D.O.R.C. ASSOCIATE-2500® Instruction Manual

15.4 Returning the Unit for Service

1. Before returning the equipment to D.O.R.C. International b.v. for service, please
contact the Service Department :

D.O.R.C. International b.v.


Attn.: Service Department
Scheijdelveweg 2
3214 VN Zuidland
The Netherlands

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.

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D.O.R.C. ASSOCIATE-2500® Instruction Manual

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

Fuses : 2 x at 100VAC~-120VAC~AT T6.3A


2 x at 230VAC~-240VAC~AT T3.15A

Power consumption : 600VA (max. ASSOCIATE® Configuration)

Air pressure input : 5-6 BAR / 35-40 lt. Flow (consumption)


(medical grade filtered air !)

Pump : Peristaltic or Venturi

I/A MODULE Preset :


Vacuum linear : from 0-500 mmHg
In case of Peristaltic Pump : also 1-50 cc/min.

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

(The ASSOCIATE® is prepared for a future combination with an Auxiliary unit)

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D.O.R.C. ASSOCIATE-2500® Instruction Manual

TRIPLE PORT ILLUMINATION MODULE :


Lamp : 24V / 150 Watts Halogen bulb, including
automatic back-up bulb

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.

Transport & Storage Conditions :


a) An ambient temperature range of -40°C to 70°C.
b) A relative humidity range of 10% to 95% without condensation.
c) An atmospheric pressure range of 500 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.

Do not dispose of as a normal domestic refuse. In order to prevent


environmental risks, please address yourself to specialized companies for the
disposal of the device and of all its accessories.

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.

The ASSOCIATE® complies with the safety requirements as described in the


international standards: IEC 60601-1 class 1 type BF & IEC 60601-2-2.

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D.O.R.C. ASSOCIATE-2500® Instruction Manual

Symbols used
The following symbols are used in and on the ASSOCIATE®:

Attention, consult accompanying documents

Equipotential grounding connection

Dispose of equipment and parts properly

Type BF equipment

Rx Only US Federal law restricts this device to sale by on the order of a licensed
physician only.

IPX4 Protected against splashing water

Protective Earth (Ground)

Alternating current

ON (Power: Connection to the mains)

OFF (Power: Disconnection from the mains)

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D.O.R.C. ASSOCIATE-2500® Instruction Manual

CAUTION HOT Surface

Non-ionizing radiation

Light source function

Scissors function

Proportional scissors function

Viscous Fluid Injection function

Air function

Pneumatic vitrectome function

Electric vitrectome function

Phaco emulsification fragmentation function

Diathermy function

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D.O.R.C. ASSOCIATE-2500® Instruction Manual

Section 17 – Warnings
A warning indicates a potentially harmful situation to yourself or others.

Electric shock hazard


• The ASSOCIATE® contains high voltage circuits.
After performing any repair, maintenance or calibration procedure, perform a final
electrical safety check and leakage current test.
• Unplug the power cord before cleaning or servicing the unit. Should the power
cord or plug become cracked, frayed, broken or otherwise damaged, it should be
replaced immediately.
• Do not touch any exposed wiring or conductive surface, while the cover is off and
the unit is energized. The voltages present, when electric power is connected to
the ASSOCIATE®, can cause injury or death.
• Never forget to wear a grounding wrist strap when working on an opened unit.
The operator should not perform any servicing except as specifically stated in the
Instruction Manual.
• Do not, under any circumstances, perform any testing or maintenance on medical
instruments, while they are being used to monitor a patient.
• Always turn ASSOCIATE® OFF before cleaning.

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 !!!!

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D.O.R.C. ASSOCIATE-2500® Instruction Manual

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.

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D.O.R.C. ASSOCIATE-2500® Instruction Manual

Section 19 - Electromagnetic Compatibility (EMC)

EMC between D.O.R.C. ASSOCIATE-2500® and other devices


It is important to install and use the equipment in accordance with the instruction in
order to prevent interference with other devices in the vicinity. The D.O.R.C.
ASSOCIATE-2500® complies with the safety requirements as described in the
international standard: IEC 60601-1-2.
Changes or modifications which are not expressly approved by D.O.R.C.
International b.v for compliance could void the user’s authority to operate the
equipment.

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

Manufacturer's Declaration - Electromagnetic Emissions

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.

Emissions Test Compliance Electromagnetic Environment - Guidance

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

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D.O.R.C. ASSOCIATE-2500® Instruction Manual

Manufacturer's Declaration - Electromagnetic Immunity

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.

Immunity Test IEC 60601 Test Compliance Electromagnetic Environment - Guidance


Level Level

Electrostatic ±6 kV contact ±6 kV contact Floors should be wood, concrete or ceramic tile.


discharge (ESD) If floors are covered with synthetic material, the
±8 kV air ±8 kV air relative humidity should be at least 30 %.
IEC 61000-4-2

Electrical fast Mains power quality should be that of a typical


±2 kV for power ±2 kV for power
transient / burst commercial or hospital environment.
supply lines supply lines
IEC 61000-4-4
±1 kV for input / ±1 kV for input /
output lines output lines

Surge Mains power quality should be that of a typical


±1 kV differential ±1 kV differential
commercial or hospital environment.
mode mode
IEC 61000-4-5
±2 kV common ±2 kV common
mode mode

<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.

30308000-H Page 82/97


D.O.R.C. ASSOCIATE-2500® Instruction Manual

Manufacturer's Declaration - Electromagnetic Immunity

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.

Immunity Test IEC 60601 Test Compliance Electromagnetic Environment - Guidance


Level Level

Portable and mobile RF communications equipment


should be used no closer to any part of the
Associate, including cables, than the recommended
separation distance calculated from the equation
applicable to the frequency of the transmitter.
Recommended separation distance
d = 1.17√P 150 kHz to 80 MHz
d = 1.17√P 80 MHz to 800 MHz
Conducted RF 3 Vrms 3 Vrms
d = 2.33√P 800 MHz to 2,5 GHz

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.

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D.O.R.C. ASSOCIATE-2500® Instruction Manual

Recommended separation distances between


portable and mobile RF communications equipment and the Associate

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.

Separation distance according to frequency of transmitter


Rated maximum output power of m
transmitter
150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2,5 GHz
W
d = 1.17√P d = 1.17√P d = 2.33√P

0,01 0,12 0,12 0,23

0,1 0,37 0,37 0,74

1 1,2 1,2 2,3

10 3,7 3,7 7,4

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.

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D.O.R.C. ASSOCIATE-2500® Instruction Manual

Appendix - A Default Settings ASSOCIATE®


The settings described here are intended to be used as guidelines to the surgeon.
However, it is the surgeon’s responsibility to fully understand the result of any
adjustment made to the preset values.

Figure 88. Default settings

A.1 Anterior Venturi (Classic)

Table 3 – Anterior Venturi


Step Function mode footswitch Power Aspiration Vacuum Flow Infusion
mode mmHg CC Pole
Setting
1 Phaco Continuous Linear 50 % Linear 60 - 70
2 Phaco Continuous Linear 50 % Linear 120 - 70
3 IA Linear 400 - 75
4 IA Min Linear 10 - 70

Vitrectomy settings ready behind the Vitrectomy Tab.


• 800 Cuts
• 200 mmHg Vacuum
• 70cm Irrigation

Footswitch lay-out :

Sub-functions Active

Sub Function Button/Switch


Diathermy 4

Figure 89. Footswitch lay-out

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D.O.R.C. ASSOCIATE-2500® Instruction Manual

A.2 Anterior Peristaltic (Classic)

Table 4 – Anterior Peristaltic


Step Function mode footswitch Power Aspiration Vacuum Flow Infusion
mode mmHg CC Pole
Setting
1 Phaco Continuous Linear 50 % Linear 60 15 70
2 Phaco Continuous Linear 50 % Linear 120 18 70
3 IA Linear 400 19 75
4 IA Min Linear 10 5 70

Vitrectomy ready behind the Vitrectomy Tab.


• 800 Cuts
• 200 mmHg Vacuum
• 25 cc Flow
• 70cm Irrigation

Footswitch lay-out :

Sub-functions Active

Sub Function Button/Switch


Diathermy 4

Figure 90. Footswitch lay-out

A.3 Posterior Venturi (Classic)

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

• Diathermy Fixed 40%


• Air 30 mmHg Standby

30308000-H Page 86/97


D.O.R.C. ASSOCIATE-2500® Instruction Manual

Footswitch lay-out :
Sub-functions Active/Standby

Sub Function Button/Switch


Diathermy 4
Light -
Air -
VFI -

Figure 91. Footswitch lay-out

A.4 Posterior Peristaltic (Classic)

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

• Diathermy Fixed 40%


• Air 30 mmHg Standby

Footswitch lay-out :
Sub-functions Active

Sub Button/Switch
Function
Diathermy 4
Light -
Air -
VFI 2

Figure 92. Footswitch lay-out

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D.O.R.C. ASSOCIATE-2500® Instruction Manual

A.5 Phaco D&C Venturi (GPC)

Table 7 – Phaco D&C Venturi


Step Function mode footswitch Power Aspiration Vacuum Flow GPC
mode mmHg CC mmHg
1 Phaco Continuous Linear 60 % Linear 60 - 75
2 Phaco Continuous Linear 50 % Linear 150 - 80
3 IA Linear 400 - 80
4 IA Min Linear 10 - 60
5 Vitrectomy Linear 500 Linear 200 - 60
cuts

Footswitch lay-out :

Sub-functions Active

Sub Function Button/Switch


Diathermy 4

Figure 93. Footswitch lay-out

A.6 Phaco D&C Peristaltic (GPC)

Table 8 – Phaco D&C Peristaltic


Step Function mode footswitch Power Aspiration Vacuum Flow GPC
mode mmHg CC mmHg
1 Phaco Continuous Linear 60 % Linear 60 14 75
2 Phaco Continuous Linear 50 % Linear 180 20 80
3 IA Linear 400 20 80
4 IA Min Linear 10 5 60
5 Vitrectomy Linear 500 Linear 200 12 60
cuts

Footswitch lay-out :

Sub-functions Active

Sub Function Button/Switch


Diathermy 4

Figure 94. Footswitch lay-out

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D.O.R.C. ASSOCIATE-2500® Instruction Manual

A.7 Phaco Chop Venturi (GPC)

Table 9 – Phaco Chop Venturi


Step Function mode footswitch Power Aspiration Vacuum Flow GPC
mode mmHg CC mmHg
1 Phaco Continuous Linear 50 % Linear 180 - 80
3 IA Linear 400 - 80
4 IA Min Linear 10 - 60
5 Vitrectomy Pneu Linear 300 Linear 200 - 60
cuts

Footswitch lay-out :
Sub-functions Active

Sub Function Button/Switch


Diathermy 4

Figure 95. Footswitch lay-out

A.8 Cool Phaco Venturi (GPC)

Table 10 – Cool Phaco Venturi


Step Function mode Foot- Power Burst Aspiration Vacuum Flow GPC
switch # mode mmHg CC mmHg
1 Phaco Burst Linear 50 % 10 Linear 180 80
2 Phaco Cool Linear 50 % Linear 180 80
Phaco
3 IA Linear 400 80
4 IA Min Linear 10 60
5 Vitrectomy Pneu Linear 300 Linear 200 60
cuts

Footswitch lay-out :

Sub-functions Active

Sub Function Button/Switch


Diathermy 4

Figure 96. Footswitch lay-out

30308000-H Page 89/97


D.O.R.C. ASSOCIATE-2500® Instruction Manual

A.9 SoftSonic Phaco Venturi (GPC)

Table 11 – SoftSonic Phaco Venturi


Step Function mode Foot- Power Duty Aspiration Vacuum Flow GPC
switch Cycle mode mmHg CC mmHg
1 Phaco SoftSonic Linear 40 % 30% Linear 180 - 80
2 IA Linear 400 - 80
3 IA Min Linear 10 - 60
4 Vitrectomy Pneu Linear 300 Linear 200 - 60
cuts

Footswitch lay-out :

Sub-functions Active

Sub Function Button/Switch


Diathermy 4

Figure 97. Footswitch lay-out

A.10 Combi 20G Venturi (GPC)

Table 12 – Combi 20G Venturi


Step Function mode Foot- Power Aspiration Vacuum Flow GPC
switch mode mmHg CC mmH
g
1 Phaco Continuous Linear 60 % Linear 60 - 75
2 Phaco Continuous Linear 50 % Linear 150 - 80
3 IA Linear 400 - 80
4 IA Min Linear 10 - 60
5 Vitrectomy Pneu Linear 900 cuts Linear 250 - 40
6 Vitrectomy Pneu Linear 2500 cuts Linear 250 - 40
7 Vitrectomy Pneu Linear 2500 cuts Linear 200 - 30
8 Vitrectomy Pneu Linear 1500 cuts Linear Flow 100 7 30
9 Oil Linear Linear 600 50
Removal
10 Oil In Linear 5 Bar - - - 30

30308000-H Page 90/97


D.O.R.C. ASSOCIATE-2500® Instruction Manual

Footswitch lay-out :

Step 1, Step 2, Step 3 & Step 4

Sub-functions Active

Sub Function Button/Switch


Diathermy 4
Light -
Air -
VFI -

Figure 98. Footswitch lay-out

Step 5, Step 6, Step 7, Step 8, Step 9 & Step 10

Figure 99. Footswitch lay-out

A.11 Combi 23G Venturi (GPC)

Table 13 – Combi 23G Venturi


Step Function mode Foot- Power Aspiration Vacuum Flow GPC
switch mode mmHg CC mmHg
1 Phaco Continuous Linear 60 % Linear 60 - 75
2 Phaco Continuous Linear 50 % Linear 150 - 80
3 IA Linear 400 - 80
4 IA Min Linear 10 - 60
5 Vitrectomy Pneu Linear 1200 cuts Linear 350 - 40
6 Vitrectomy Pneu Linear 2500 cuts Linear 350 - 40
7 Vitrectomy Pneu Linear 2500 cuts Linear 300 - 30
8 Vitrectomy Pneu Linear 1800 cuts Linear Flow 100 7 30
9 Oil - Linear - Linear 600 - 50
Removal
10 Oil In Pneu Linear 5 bar - - - 30

30308000-H Page 91/97


D.O.R.C. ASSOCIATE-2500® Instruction Manual

Footswitch lay-out :

Step 1, Step 2, Step 3 & Step 4


Sub-functions Active

Sub Function Button/Switch


Diathermy 4
Light -
Air -
VFI -

Figure 100. Footswitch lay-out

Step 5, Step 6, Step 7, Step 8, Step 9 & Step 10

Figure 101. Footswitch lay-out

A.12 Dual Vitrectomy 23 G (GPC)

Table 13 – Dual Vitrectomy


Step Function mode Foot- Power Aspiration Vacuum Flow GPC
switch mode mmHg CC mmHg
start End start End
1 Vitrectomy Pneu Linear 2200 1200 Linear 100 450 - 40
cuts cuts
2 Oil In Pneu Linear 5 bar - - - 30

Footswitch lay-out :

Sub-functions Active

Sub Function Button/Switch


Diathermy 1
Light -
Air -
VFI -

Figure 102. Footswitch lay-out

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D.O.R.C. ASSOCIATE-2500® Instruction Manual

A.13 Combi Dual 23G (GPC)

Table 14 – Combi Dual 23G


Step Function Mode Foot- Power Aspiration Vacuum Flow GPC
switch mode mmHg CC mmHg
1 Phaco Continuous Linear 60 % Linear 60 - 75
2 Phaco Continuous Linear 50 % Linear 150 - 80
3 IA Linear 400 - 80
4 IA Min Linear 10 - 60
5 Vitrectomy Pneu Linear Start End Linear Start End - 40
2200 1200 100 450
cuts cuts
6 Oil Linear - - 600 - 50
Removal
7 Oil In Pneu Linear 5 bar - - - 30

Footswitch lay-out :
Sub-functions Active

Sub Button/Switch
Function
Diathermy 4
Light -
Air -
VFI -

Figure 103. Footswitch lay-out

A.14 Posterior Peristaltic 23G (GPC)

Table 15 – Posterior Peristaltic 23G


Step Function mode footswitch Power Aspiration Vacuum Flow Infusion
mode mmHg CC Pole
Setting
1 Vitrectomy Pneu Linear 1200 cuts Linear 350 25 40
2 Vitrectomy Pneu Dual 2500 cuts Linear 250 12 40
3 Vitrectomy Pneu Dual 2500 cuts Linear 150 7 30
4 Oil In Pneu Linear 5 bar - - - 30

Footswitch lay-out :

Sub-functions Active

Sub Function Button/Switch


Diathermy 7
Light -
Air -
VFI -

Figure 104. Footswitch lay-out

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D.O.R.C. ASSOCIATE-2500® Instruction Manual

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

Sub Function Button/Switch


Diathermy 4
Light -
Air -
VFI 2

Figure 105. Footswitch lay-out

A.16 Oil Out

Table 17 – Oil out


Step Function mode footswitch Power Aspiration Vacuum Flow Infusion
mode mmHg CC Pole
Setting
1 Oil Out Pneu Linear - Linear 600 - 70
2 Vitrectomy Pneu Linear 1500 Linear 250 - 50
cuts

Footswitch lay-out :

Sub-functions Active

Sub Function Button/Switch


Diathermy 4
Light -
Air -
VFI -

Figure 106. Footswitch lay-out

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D.O.R.C. ASSOCIATE-2500® Instruction Manual

Appendix - B Quick Programming

Figure 107. Quick programming

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D.O.R.C. ASSOCIATE-2500® Instruction Manual

Figure 108. Quick programming

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D.O.R.C. ASSOCIATE-2500® Instruction Manual

Appendix - C Footswitch Reminder


Copy this page and tape it to the infusion pole as a reminder how the
footswitch is programmed.

------------------------------------------------------------------------------------------

Figure 109. Footswitch reminder

30308000-H Page 97/97

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