Cod. 389889 Rev.

0434

GB

PACLINE
PORTABLE PACHYMETER

Installation and
operating manual

OPTIKON 2000 S.p.A.

 TABLE OF CONTENTS

GB
WARNINGS .......................................................................................................... 4

1.1 SYSTEM DESCRIPTION .......................................................................... 6

1.2 BASIC PACKAGE ........................................................................................ 6

1.3 INSTALLATION ............................................................................................ 7

2.1 PACLINE PACHYMETER OPERATION .............................................. 8

2.2 PACHYMETER OPERATING PAGE .................................................... 9

2.3 SETTING THE OPERATING PARAMETERS .................................. 11

3.1 MAPS PROGRAMMING ............................................................................ 12

4.1 PROBE TEST ................................................................................................ 13

5.1 PAPER REPLACEMENT .......................................................................... 13

6.1 TECHNICAL SPECIFICATIONS ............................................................ 15

7.1 PACLINE REGISTRATION FORM ........................................................ 16

 WARNINGS

The following warnings will aid the user to provide adequate safeguards
to assure safe, troublefree performance:
1. ALL MEDICAL PERSONNEL SHOULD READ AND UNDERSTAND
THE INSTRUCTIONS IN THIS MANUAL BEFORE THE SYSTEM IS
USED. DO NOT ATTEMPT TO USE THE SYSTEM IF IT FAILS TO
PERFORM AS SET OUT INTHE OPERATION PROCEDURES, IN
THIS MANUAL.
2. USE OF THIS SYSTEM IS A MATTER OF PROFESSIONAL MEDICAL
JUDGMENT IN ALL CASES. OPTIKON 2000 S.p.A. IS NOT
RESPONSIBLE FOR ANY CLINICAL PROBLEM RESULTINO
FROM MISHANDLING THIS INSTRUMENTAND MAKES NO MEDICAL
RECOMMENDATIONS.
3. THE SYSTEM SHOULD NEVER BE USED IN THE PRESENCE
OF FLAMMABLE ANAESTHETICS, DISINFECTING AGENTS,
CLEANING AGENTS, ETC., DUE TO POSSIBLE FIRES OR
EXPLOSION.
4. THE PACHYMETER PROBE IS DELIEVERED NOT STERILIZED
AND IT IS NOT DISINFECTED.
THE PROBE MUST BE DISINFECTED OR STERILIZED BY THE
USER BEFOREEVERY USE.
5. DO NOT SUBJECT THE PROBE TO HOT AIR STERILIZATION,
CHEMCLAVE OR AUTOCLAVE. GAS STERILIZATION UP TO 60°C
CAN BE TOLERATED BY THE PROBE.
6. THE PROBE HANDPIECE MUST BE HANDLED WITH CARE.
FALLS AND SHOCKS CAN EASILY CAUSE PERMANENT DAMAGE
TO THE TRANSDUCER.

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7. FOR OPERATING SAFETY, DO NOT INSTALL THE SYSTEM IN
A LOCATION WHERE IT WILL BE EXPOSED TO HEATING
EQUIPMENT OR RADIATORS, DIRECT SUNLIGHT, AND ANY
OTHER SOURCE OF HIGH TEMPERATURES. GB
8. NON SOTTOPORRE LA SONDA A STERILIZZAZIONE AD ARIA
CALDA O ADAUTOCLAVE CHIMICA.
9. OPTIKON 2000 GUARANTEES ELECTRICAL SAFETY ONLY
WHEN THE CONSOLE IS CONNECTED TO THE ORIGINAL AC/DC
ADAPTER.
10. DO NOT OPEN THE CONSOLE ENCLOSURES. THERE ARE NO
USER ACCESSIBLE PARTS INSIDE THE INSTRUMENT. INTERNAL
DEVICES MUST BE SERVICED BY QUALIFIED SERVICE
PERSONNEL.
11. TURN OFF THE MAIN POWER SWITCH WHENEVER THE
INSTRUMENT IS NOT IN USE.

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1.1 SYSTEM DESCRIPTION
The Optikon 2000 Pacline is an advanced, microprocessor based,
portable unit, for the measurement of the thickness of the cornea .
The measurement technique is not dangerous for the patient, as it is based
on small ultrasounds pulses, emitted by the probe piezo transducer.
The Optikon 2000 Pacline operates with time saving semplicity and it is
very easy to use, nevertheless we strongly recommend to read this
manual to get the best performances from the instrument. After that, the
short instruction summary printed by the instrument (pushing the HELP
key), will be clear enough to operate, in most of the cases, without
consulting this guide.

1.2 BASIC PACKAGE

The Pacline basic package includes:

1 Pachymeter console
1 Solid tip probe, 20 Mhz
1 AC-DC adapter
1 Transportation bag.
1 User manual
2 Rolls of thermal paper

If physical damage is found on any parts, immediately notify the damage

to the carrier and to Optikon 2000 Sales office for replacement.

KEEP UP TO DATE!
Registration form is on the last page of this manual. Mail or fax this
completed form today to receive new product data and new literature
when issued.

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1.3 INSTALLATION
The following procedure should be observed to install the system:

1) Place Pacline pachymeter on a secure plane. The handle of the GB

instrument can be pulled outward at the sides and rotated to be used
as an adjustable support ; orientate the console in a convenient
position.
2) Check that the voltage supply indicated on the AC-DC adapter
corresponds to the value used in your country, then insert the
connector to the rear panel (12V).
3) Connect the optional footswitch
4) Fix the adhesive probe support in a comfortable position (We suggest
the external side of the console handler)
5) Insert the probe connector into the PACLINE front panel .

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2.1 PACLINE PACHYMETER OPERATION
THE AUTO-PRIMING AUTO-CHECK PAGE
Depress "POWER" switch, located on the rear panel to turn ON the
instrument.
The PACLINE performs an automatic priming and check of the instrument
connections and resources, then it reports the current status on the
screen:
SELF TEST: This is the hardware check test report (if no fault is found:
Passed, otherwise the error code ERR XXX is reported).
PRINTER: Reports if the printer has been recognized (Ready or Absent)
PC-LINK: Reports if a connection to a personal computer is detected
on the RS232 rear panel connector (Ready or Absent)

In Test page, the following keys can be used:

CLEAR: enters the pachymetry operating page
SAVE: enters the parameters setting page
PRINT: prints a summary of the main instructions
UP arrow: advances the printer paper

In the parameters setting page, it is possible to reset all the parameters

and the programmed maps. The reset operation can be required in case
of upgrade of the internal program, (to be done from technical personnel).

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2.2 PACHYMETER OPERATING PAGE
This screen page contains all the informations and settings required to
make the corneal map thickness examination.
This means to acquire, each one of the points indicated by a cursor, on GB
the map.
The screen is subdivided in three areas: on the left ,the map pattern is
displayed, in the middle the echoes from the probe with the position
number, and on the right the operating parameters and the average
thickness (AVG) in micron followed by the standard deviation.
When entering the operative page, the PACLINE starts automatically the
acquisition phase, without the need of a "start " footswitch.
The message "SEARCH" flashes on the LCD screen indicating the
instrument is ready to measure.
The probe can be placed now on the cornea waiting for autofreeze.
A short sound prompts the measure is ready.
A short pause of two seconds follows, allowing the operator to evaluate
the result, to save it and to move the probe on the next point.
When all the map points are acquired, two consecutive tones alert the
end of the examination and the cursor resets to first map position.

FIG.1 FRONT PANEL

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Keyboard functions in the operative page:

CLEAR: cancels all the points of the map (for a new

examination)
PROG: enters the map programming page (see chapter 3.1)
TEST: enters the probe testing page (see chapter 4.1)
SAVE: save the actual AVG measure; the cursor steps
on the next point.
PRINT: makes a printout of the map with thickness scaled
by the bias factor
LEFT/RIGHT arrows: move the cursor on the map,
decrementing/incre menting the position number.
The AVG and echoes relative to that position are
displayed.
When a parameter is pointed out, the
horizontal arrows work in a different mode:
they change the parameter value, not the
position on the map.
UP/DOWN arrows: select the parameter field
(MODE, MAP, BIAS, AUDIO) to be changed.
ENTER: confirms the value of the parameter pointed
out on the screen and returns to acquisition
mode. On the contrary, if none of the parameters
is selec ted, the ENTER key selects a parameter.
FOOTSWITCH: works as the SAVE key.

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2.3 SETTING THE OPERATING PARAMETERS
The operating parameters allow to personalize the procedure for different
needs and examination techniques . The operating parameters should be
set once for all or can be changed before a new patient. To change a GB
parameter, press UP or DOWN arrows and repeat until the desired
parameter field is reached. The selected field is displayed in reverse
mode (dark background). Then push the RIGHT or LEFT arrow to change
the parameter value, conforming to your requirements. Finally push the
ENTER key to end the selection.
The following is a list of the available parameters settings:
MODE= Acquisition mode
Three modes available:
1M- - : manual saving on 1 Measure
The operator can save manually the measure in memory, pushing the
SAVE key (or the footswitch).
In this case, the relative box on the map is fìlled and the map pointer
steps to the successive position.
1M+S: Autosaving mode. Autofreezes on 1 Measure
Then, SAVE operation is accomplished automatically without the operator
intervention.
2M+S: Averaging mode
Two measure are required on the same point to make the automatic
average.
If the two measure are reasonably dose (+/- 10 microns), the save operation
occurs automatically after the second acquisition, otherwise another
measure is required.
MAP= Map Number
Standard maps (from O to 3) and programmable maps (from 4 to 13) can
be selected.
The map display is composed of standard position markers (+) and
programmed points markers (square box). The box is filled when the
relative measure has been saved.
BIAS= Scaling factor for the printout.
Ali the saved thickness are percentually scaled by the bias value.
The bias value affects only the printed out thickness, not the values dis-
played on the screen.
The bias value can be incremented or decremented in steps of 1 (%).

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AUDIO= Acoustical prompting
At autofreeze, it is possible to activate sound prompting as well as vocal
prompting.
Change to VOX for the speech of the thickness or select BEEP for
acoustical tones.

3.1 MAPS PROGRAMMING

This page of the screen allows to built custom maps. Ten maps are available
for programming, ranging from number 4 to 13. Push the key Program to
enter the programming page. The first map available (among the
unprogrammed ones) is automatically displayed, then the PROGRAM
MENU is prompted indicating the keys to be used:

KEY name Action

CLEAR: Cancels all the programmed points (displayed as
empty boxes).
ENTER: programs the point indicated by the cursor, draws
a box in the map.
LEFT/RIGHT arrows: move the cursor back/forward in the map area.

PROG: Terminates the map programming session, returning

to acquisition mode.

Use the Left/right arrows to move the square cursor over the first desired
point of the map, then press ENTER. Repeat, as above, for all the other
points.
In case of mistake, the map must be cleared (CLEAR) and reprogrammed
from the first point.
It is important to program the points respecting the measurement
sequence .

If nothing happens pushing "PROG", this means that the displayed map
is not programmable (number 0 to 3 are fixed maps); in this case, select
a different map number.

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4.1 PROBE TEST
In the operating page, the autofreezing can be checked by using the
tester supplied with the probe.
Wet the probe tip, then insert the tip in the cavity and softly touch the GB
black membrane; move gently the probe until autofreezing occurs.
The measurements can be saved on the map as well as printed.
The supplied tester is not useful to test the instrument calibration.
To test probe efficiency and instrument calibration use a glass full of
water.
Softly touch the water surface with the tip, push the TEST key when
ready, avoid moving the probe during the test phase.
If test is unsuccessful, try to modify the probe inclination and press TEST
key again.
If Test is passed, the PACLINE prompts the message "PROBE OK" on
the screen and a series of measurements starts, followed by some
"beeps ".
During the test, probe echoes are displayed on the screen.
Test takes few seconds to be completed, then some statistical results are
provided (MIN, MAX, AVG). The displayed AVG value should match the
Test value, printed either on the probe box or in the attached probe
instructions.
Press TEST key to repeat the test or any other key to exit the Test mode.

5.1 PAPER REPLACEMENT

A pale pink line appearing on the thermal paper indicates that the internal
printer is running out of paper. To load a new roll of thermal paper,
proceed as follow:
1) Turn the instrument on, thus entering the opening page.
2) Remove the lid that conceals the paper receptacle (on the upper
cover of the instrument).
3) Insert the edge of the paper roll in the printer slit (see the drawing on
the next page).
4) Depress the UP arrow to advance paper until it goes through the printer
and comes out approximately five centimeters (2").
5) Place the paper roll in its receptacle and drive the paper lead through
the slit of the paper receptacle lid.
6) Close the paper receptacle with its lid.

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14
THERMAL PAPER SHOULD BE INSERTED
AFTER CUTTING ITS LEADING EDGE AS
SHOWN HERE
THREADED HOLE FOR LID LOCKING
THUMB SCREW PAPER FEED ROLLER INLET
(UPPER)
PAPER ADVANCE KNOB

THERMAL PAPER

THERMAL PAPER
ROLL HOLDER
6.1 TECHNICAL SPECIFICATIONS
Automatic acquisition modes:
• Manual saving mode
GB
• Autosaving mode
• Averaging and autosaving mode
• Test mode

Map programming:

Number of stored maps : 14

Number of map points : 33 max

POWER SUPPLY 13.5V de , +/- 10%, 25 WATT

SIZE 6“ x 9“ x 11“
WEIGHT 2.2 Kg (5lbs)
PROBE 20 Mhz, solid tip probe
CLINICAL ACCURACY 10 micron
INSTRUMENT RESOLUTION 0.5 micron
MEASUREMENT RANGE 0.28 - 1.0 mm
COMPUTER INTERFACE RS232, 9 PIN CONNECTOR
PRINTER thermal 40 columns, 320 dot
SCREEN LCD display, 240 x 128 dots
INTERNAL BATTERY 3.6V, lithium , 10 years lifetime

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7.1 PACLINE REGISTRATION FORM
OPTIKON 2000 S.p.A. maintains a mailing list of people interested in our
products and new product developments. If you wish to be placed in our
mailing list, please complete the registration form below and mail or fax it
to us. This form is for information and registration only, it does not obligate
you to order.

OPTIKON 2000 BIOLINE REGISTRATION FORM

MAIL TO: OPTIKON 2000 S.p.A.

VIA DEL CASALE DI SETTEBAGNI, 13
00138 ROME (ITALY)
or send by fax: + 39 06 8888388
NAME ..............................................................................................................................................................................................................................................

ORGANIZATION OR OFFICE LOCATION ....................................................................................................

ADRESS ....................................................................................................................................................................................................................................

CITY ........................................................................................................................................................STATE.................................ZIP..................

COUNTRY ................................................................................................................TEL ............................................................................................

SIGNATURE ................................................................................................................................................................................

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