Oertli OS3B Operating instructions
Operating Instructions
OS3 Base unit, VC830100
VV016011E
Phaco Emulsification System
0297
29.05.09 VV016011E 1
Operating Instructions OS3 Base unit, VC830100
Contents 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
29.05.09 VV016011E 2
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.
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.
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!
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.
29.05.09 VV016011E 3
3 Control panel
The display and adjustment area
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
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
power as automatic controlled)
Vitrectomy: Number of cuts per minute
Phaco: Power in % and elapsed ultrasound time
(relative to power)
The surgeon display
Shows the number of the selected surgeon memory or name
of the surgeon.
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 familia- rization 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"!
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.
29.05.09 VV016011E 4
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).
(see 8.3.3).
In ParaProg you can specify per surgeon whether Pulse or burst or pulse and
burst shall be available.
Light indicator on: OCC-M function ready
Slow flashing: OCC-M memory ready for programming
Rapid flashing: OCC-Mfunction 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.
I/A system
Flow indicator Suction-(vacuum) IOP indicator
indicator
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.
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
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).
29.05.09 VV016011E 5
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
Reflux
0
1
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 12-3 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.
2
3
29.05.09 VV016011E 6
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 + Sideways, right
Linear instrument control
Aspiraton*
Phaco*
VIT*
DIA LOW (linear)
CAPS REGULAR (fix)
VISCO INJECTION (linear)
Reflux****
Instant diathermy
Pulse on/off (linear phaco)
Top left Top right
Selector**
Venturi-Peristaltic
or AIR on/off
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 lower
or
AIR 3-2-1
or decrease
* 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)
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
Backwards
REFLUX
IRR off
Heel rightHeel left
Bottle higher
or
AIR 1-2-3
or increase
AIR pressure
29.05.09 VV016011E 7
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