Operating Instructions OS3 Base unit, VC830100
VV016011E
Phaco Emulsification System
0297
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1 |
Operating Instructions OS3 Base unit, VC830100 |
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Contents |
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Page |
1 |
Application and description |
3 |
2 |
Points to note and hazards |
3 |
3 |
Control panel |
4 |
3.1 |
Arrangement of control and indicator elements |
4 |
4 |
Control pedal |
6 |
5 |
Mains connection / switching the unit on/off |
8 |
5.1 |
Replacing fuses |
8 |
6 |
Setting up the I/A system |
8 |
6.1 |
Installing the cassette |
9 |
6.2 |
Filling the I/A system (PREOP) |
10 |
6.3 |
Removing and cleaning the cassette |
10 |
6.3.1 |
Cassettes for single use (Fig. 3,4) |
10 |
6.3.2 |
Autoclavable cassette fig. 5 (the instructions on the accompanying packaging insert are binding) |
10 |
7 |
Attaching the operating instruments |
11 |
7.1 |
Suction/rinsing instrument |
11 |
7.2 |
Ultrasonic phaco handpiece |
11 |
7.3 |
Diathermy instruments |
12 |
8 |
Operating the unit |
12 |
8.1 |
Storing values (multimode memory) |
12 |
8.2 |
I/A |
13 |
8.2.1 |
I/A operation |
13 |
8.2.2 |
Changing between venturi/peristaltic operation |
13 |
8.2.3 |
Infusion pressure IOP |
13 |
8.2.4 |
Continuous irrigation |
14 |
8.2.5 |
Reflux |
14 |
8.2.6 |
Proportional Override |
14 |
8.3 |
Ultrasonic phaco |
14 |
8.3.1 |
Phaco test |
14 |
8.3.2 |
Phaco operation |
14 |
8.3.3 |
Phaco pulse and phaco burst |
15 |
8.3.4 |
CMP Phaco |
15 |
8.3.5 |
Occlusion Mode Phaco |
15 |
8.3.6 |
Proportional override for Phaco |
15 |
8.3.7 |
Setting of values for additional aspiration and phaco-power in DUALLINEAR 2 mode |
16 |
8.4 |
Diathermy |
16 |
8.5 |
HF CUT |
16 |
8.5.1 |
Capsulotomy |
16 |
8.5.2 |
Glaucoma |
16 |
8.6 |
Vitrectomy |
17 |
9 |
System communication |
17 |
9.1 |
Visual displays |
17 |
9.2 |
Acoustic signals |
17 |
9.3 |
Voice confirmation |
17 |
10 |
Pre-settings using ParaProg |
18 |
11 |
Selection of setting values |
18 |
12 |
Cleaning and sterilisation regulations |
19 |
12.1 |
Cleaning the Control Device |
19 |
12.2 |
Cleaning the Instruments |
19 |
12.3 |
Sterilisation |
19 |
13 |
Accessories and replacement parts |
19 |
14 |
Authorised service centres |
19 |
15 |
Technical data |
20 |
16 |
Overview of messages, warnings and error messages |
21 |
17 |
Symbols |
22 |
18 |
Calibration and maintenance |
22 |
19 |
Disposal |
22 |
20 |
OS3 Base Unit, VC830100, Overview |
23 |
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1 Application and description
The OS3 operating unit is used in surgical procedures to the anterior and posterior segments of the eye. It performs all essential functions including irrigation and aspiration, ultrasound Phaco, bipolar diathermy for haemostasis and coaptation of conjunctiva, diathermic capsulotomy, diathermic tissue cutting and the drive of vitrectomy instruments. The unit can be supplemented with the VC830200 module for carrying out vitreo-retinal procedures.
The unit actuates and controls companion instrumentation within the performance limits chosen by the operator and as set on the control panel. A foot pedal effects fine adjustments within the pre-set limits. The unit is extremely easy to use. Frequently used equipment settings can be stored and recalled.
The unit may only be used with the Oertli instruments recommended and supplied by the manufacturer (see Section 13).
The unit may only be operated by trained personal. Correct settings are the responsibility of the surgeon.
The unit is not suitable for surgical procedures outside the eye. If in doubt, contact the manufacturer.
2 Points to note and hazards
IMPORTANT
Please read these instructions very carefully before using the apparatus for the first time!
IMPORTANT!
Before connecting the unit, check that the voltage shown on the rating plate is the same as that of the operating room!
IMPORTANT!
1. Patients with heart pacemakers or pacemaker electrodes may be at risk in that the functioning of the pacemaker may be impaired or the pacemaker itself damaged. If in doubt, the cardiology department must be consulted.
2. The functioning of other electro-medical equipment may be affected during the operation of bipolar diathermy, capsulotomy and vitrectomy cutters.
IMPORTANT!
Where high-frequency diathermy, HF-cut or vitreous cutting is used simultaneously with physiological monitoring equipment on the same patient, any monitoring electrodes must be placed as far as possible from the diathermy points. Needle monitoring electrodes are not recommended. Monitoring systems incorporating high-frequency current limiting devices are recommended in all cases.
IMPORTANT!
The correct choice of instrument settings is the responsibility of the surgeon! Values given in this instruction manual are suggestions only.
IMPORTANT!
Only instruments and accessories supplied by the manufacturer and listed in Section 13 may be used!
IMPORTANT!
Only persons authorised by the manufacturer may carry out modifications and repairs, otherwise the proper functioning of the unit may be impaired.
IMPORTANT!
While operating in diathermy or HF-cut mode, the instrument tip must be monitored carefully. The pedal must be released immediately as soon as tissue begins to overheat excessively.
IMPORTANT!
All accessories must be checked regularly! Diathermy cables in particular should be checked for possible damage to the insulation.
IMPORTANT!
The unit must never be used in areas containing inflammable anaesthetics!
IMPORTANT!
The cart with the tray fully stretched out can tip over if inclined more than 6°! The cart must only be moved when the tray is fully folded and stored.
IMPORTANT!
The operator is responsible for compliance with EN ISO 60601-1:2007.
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3 Control panel
All settings for the operation of the OS3 operating unit can be undertaken using the control panel (pre-settings are made using ParaProg. See Section 10). Visual displays serve to show the current operating state of the unit and the current values. The buttons respond to light pressure, which can also be applied using a sterile swab or the special sterile operating pen (VE850003) available from the manufacturer.
Depending on the stage of the operation or the setting of the operating pedal, certain buttons will be blocked. This feature offers increased protection against improper use.
The execution of a button command is accompanied by corresponding changes in the display field. There is no change in the display when a blocked button is pressed.
The control panel can be separated from the unit and placed in a sterile bag for use in the sterile area. To do so, lift and disengage the control panel from below. Alternatively, an additional control panel VE 830025 or a remote controller VE 830020 can be connected to socket M3.
3.1 Arrangement of control and indicator elements
Displays and settings for operation functions
Displays and settings
I/A system
Auxiliary functions
The controls and displays are grouped in such a way that the unit can be operated after just a short familiarization period, even in semi-darkness. The top half of the control panel is the display and adjustment area for the phaco, vitrectomy, diathermy and capsulotomy functions. It shows at a glance the operating state of the unit and the current values. The values displayed can be increased or decreased using the dark green arrow buttons immediately beneath the display.
The lower half of the control panel houses the displays and adjustment buttons for the irrigation/aspiration system.
The lowest row on the control panel contains all the buttons for the auxiliary functions.
Please familiarise yourself thoroughly with this ergonomic arrangement of the control elements; it will quickly enable you to operate the unit almost "blind"!
The display and adjustment area
Function display |
Value display |
Surgeon display |
The function display
Shows which function has been selected and is active. The display matches the symbol on the function button last pressed. Any auxiliary functions selected are also indicated: PULS by a P, Burst by a B, CMP by CMP and IRR by a falling droplet.
The value display
Shows the limit value selected for the instrument being used (or the current value when the pedal is depressed).
Diathermy: |
Power in % |
HF CUT: |
GLAUCOMA or CAPSULE (no indication of |
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power as automatic controlled) |
Vitrectomy: |
Number of cuts per minute |
Phaco: |
Power in % and elapsed ultrasound time |
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(relative to power) |
The surgeon display
Shows the number of the selected surgeon memory or name of the surgeon.
Arrow buttons
The arrow buttons can be used to reduce (down arrow) or increase (up arrow) the value display in the panel immediately above. Press normally to change the values slowly or in single steps, and depress fully to change the values quickly.
0:00 button
If the two arrow buttons are pressed simultaneously, ultrasound time is reset to 0.
PEDAL light indicator
Lights up green when the pedal is active. Certain control elements are then blocked for safety reasons.
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OCC-M button and light indicator
The OCC-M function is switched on and off by light pressure to the button. Pressing the button more forcibly prepares the OCC-M memory for programming (see 8.3.4).
Light indicator on: |
OCC-M function ready |
Slow flashing: |
OCC-M memory ready for programming |
Rapid flashing: |
OCC-M function active |
Function selection area
DIA button
Sets the unit to DIATHERMY function at the output last selected.
HF CUT button
Sets the unit to the CAPSULE (capsulotomy) or GLAUCOMA (as last selected) function with automatic output control.
VIT A button
Sets the unit to VITRECTOMY function, to operate the vitrectomy instruments connected to the VIT A port and using the values selected for cut rate, flow and suction.
VIT B button
Sets the unit to VITRECTOMY function, to operate the vitrectomy instruments connected to the VIT B port and using the values selected for cut rate, flow and suction.
VIT PN button
Sets the unit to VITRECTOMY function, to operate the vitrectomy instruments connected to the VIT PN port and using the values selected for cut rate, flow and suction.
PHACO1 button
Sets the unit to ultrasonic phaco or CMP (as last selected) function, Program 1, with the values stored in this program.
PHACO2 button
Sets the unit to ultrasonic phaco or CMP (as last selected) function, Program 2, with the values stored in this program.
PHACO3 button
Sets the unit to ultrasonic phaco function or CMP (as last selected), Program 3, with the values stored in this program.
CMP button
Switches on CMP operation (for phaco 1, 2, 3) and switches it off when the CMP button is pressed again. If the button is held down, CMP frequency and cooling factor can be changed (see 8.3.4).
PULSE button
Switches on pulse or burst operation (for phaco 1, 2, 3) and switches it off when the button is pressed again. If the button is held down, the pulse or burst parameters can be changed
(see 8.3.3).
In ParaProg you can specify per surgeon whether Pulse or burst or pulse and burst shall be available.
I/A system
Flow indicator |
Suction-(vacuum) |
IOP indicator |
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indicator |
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Flow indicator
In peristaltic mode, this shows the maximum set aspiration flow rate (or the current rate if the pedal is depressed). In venturi operation, it indicates the set venturi speed (100% = immediate creation of vacuum), also called the venturi effect.
Suction (vacuum) indicator
Shows the set limit value for suction (vacuum). The current value is shown if the pedal is depressed.
IOP indicator
Shows the current bottle height in cm. If used in conjunction with Vitrex module VC830200, the air pump pressure (AIR function) can also be indicated here. Press the IOP button on the Vitrex unit to do this.
I/A1 button
Sets the unit to irrigation/aspiration function, Program 1, with the respective stored values for flow rate (or venturi speed) and suction.
I/A2 button
Sets the unit to irrigation/aspiration function, Program 2, with the respective stored values for flow rate (or venturi speed) and suction.
I/A3 button
Sets the unit to irrigation/aspiration function, Program 3, with the respective stored values for flow rate (or venturi speed) and suction.
IRR button and light indicator
Switches on the continuous irrigation function, and switches it off if pressed again. When the light indicator is illuminated: the IRR function is ready (see 8.2.4). If the button is held down, the irrigation valve remains open.
Venturi button and light indicator
Switches between the peristaltic and venturi pump. When the light indicator is illuminated: the venturi pump is ready (see 8.2.2).
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Auxiliary functions
RESET button
Can be pressed at any time, and brings the unit to an immediate stop. Ultrasound time is reset to zero. Reset of the Ultrasound time also after installation of the cassette.
The RESET button restarts the internal processor and is thus an escape button in a situation where, for some reason, normal operation is no longer possible.
AUX button
Used (button held down) to adjust the volume of acoustic signals (SOUND) and voice messages (VOICE). Also adjusts the IOP indicator (bottle height).
VOICE button
Repeats or stops the current voice message. The scope of information given can be defined in ParaProg.
PREOP button
Initiates the filling and rinsing function, and stops the procedure if pressed again. Completes the procedure with a phaco test if PREOP is started when in phaco 1, 2, 3 operating mode.
TEST button
Starts the phaco test when the unit is set to phaco 1, 2 or 3, or activates the connected vitrectomy instrument during button depression, if the unit is in VIT A, VIT B or VIT PN mode.
NOTE: If not willingly activated PREOP or Phacotest also can be interrupted by pressing pedal with the heel. Then the display shows the message “PREOP discontinued” or “Phaco Test discontinued”.
4 Control pedal
The control panel is used to regulate the I/A system and all instruments. It must be connected to the pedal connection socket (M1) on the rear of the unit. The control pedal can be moved vertically (downwards) and
horizontally (sideways) and has four switching elements, which, for safety reasons, can only be accessed by lifting the foot.
The vertical plane
Fig. 1
4 |
0 |
Reflux |
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|
1 |
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2 |
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3 |
The vertical range – from zero to the fully depressed position
– is divided into a maximum of three ranges: irrigation, aspiration and instrument activation. These three ranges lie between positions 0, 1, 2 and 3. If the pedal is pressed slowly, the settings 0-3 can be felt as a slight resistance. This resistance can be changed in ParaProg (low, medium, high).
The pedal is brought to position 4 by pressing with the heel, and this position is always used to activate reflux.
The number of positions and the amount of travel between them can be changed in ParaProg. This is described in detail in the ParaProg user manual, VV016013E.
The vacuum is always off in position 0.There is no suction, and the instruments are inactive.
The service engineer can adjust the firmness of the pedal (resistance to movement).
The horizontal plane
In the horizontal plane, the pedal can be moved to the left and right. The pedal can be moved horizontally from any of the vertical positions, i.e. even when the pedal is depressed.
If duallinear operation is selected in ParaProg (see Section 10), the chosen instrument is controlled linearly by moving the pedal to the left (i.e. the power of the instrument changes in proportion to the deflection).
Moving the pedal to the right switches between the multimode memories of the function just used (e.g. phaco 1- 2-3 etc.).
ParaProg (see Section 10) can be used to specify whether 2 or 3 memories should be available.
In ParaProg (se Section 10) you can invert the assignments of left and right of the horizontal movement to right and left.
Switching elements
The two round switches (heel switches) can be operated with the heel (the pedal does not have to be in the zero position) to change the infusion pressure (bottle height) or air pump pressure. Pressure is always reduced with the left heel switch, and increased with the right heel switch.
The two switches on the pedal grip (TOP switch) are positioned so that they can only be activated after the pedal has been returned to the zero position (foot raised).
TOP left
Switches between the basic functions (selector) e.g. I/A, CAPS, Phaco, etc. Each surgeon can enter his preferred sequence in ParaProg.
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Fig. 2
Overview of the pedal controls
Pos. 3 Instrument (Phaco, VIT, DIA, CAPS, Override)
Pos. 2 ASP
Pos. 1 IRR
Pos. 0
Forwards
Sideways, left +
Linear instrument control
Aspiraton*
Phaco*
VIT* Top left
DIA LOW (linear) CAPS REGULAR (fix)
VISCO INJECTION (linear)
Reflux****
Selector**
Instant diathermy
Pulse on/off (linear phaco)
Heel left
Bottle lower or
AIR 3-2-1 or decrease
AIR pressure
*Only when 'duallinear' has been selected in ParaProg
**Allows you to change between the basic functions
***Single cut or scissors close
****Only when selected in ParaProg
+ Unless left and right are inverted in ParaProg (INVERT)
Backwards
REFLUX IRR off
Top right
Venturi-Peristaltic
or AIR on/off
Heel right
Sideways, right
I/A 1-2-3
Phaco 1-2-3 or Pulse on/off* VIT A-B-PN or Cut-SC*** DIA HIGH (linear)
CAPS HIGH (fix)
VISCO EXTRACTION (linear)
Bottle higher or
AIR 1-2-3 or increase
AIR pressure
TOP right
Switches between the venturi and peristaltic pump. Alternatively, in ParaProg this switch can also be set to switch the air pump on/off.
NOTE: If the Venturi cassette VV635010 is being used, the right TOP switch is automatically set to air pump AIR
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